Amitriptyline HCl CF may be available in the countries listed below.
Amitriptyline hydrochloride (a derivative of Amitriptyline) is reported as an ingredient of Amitriptyline HCl CF in the following countries:
International Drug Name Search
Nifluderm may be available in the countries listed below.
Niflumic Acid is reported as an ingredient of Nifluderm in the following countries:
International Drug Name Search
Depreks may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Depreks in the following countries:
International Drug Name Search
Iodiojet may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sodium Iodide is reported as an ingredient of Iodiojet in the following countries:
International Drug Name Search
Anxyrex may be available in the countries listed below.
Bromazepam is reported as an ingredient of Anxyrex in the following countries:
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Treating pain including, headache, muscle aches, sprains, tooth extraction and toothache, menstrual cramps, arthritis and rheumatism, and pain and fever of the common cold. It may also be used for other conditions as determined by your doctor.
Aspirin/Caffeine is a combination salicylate and stimulant. It works by blocking several different chemical processes within the body that cause pain, inflammation, and fever. It also reduces the tendency for blood to clot.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Aspirin/Caffeine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Aspirin/Caffeine. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Aspirin/Caffeine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Aspirin/Caffeine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Aspirin/Caffeine.
Some people who use Aspirin/Caffeine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.
If you stop taking Aspirin/Caffeine suddenly, you may have WITHDRAWAL symptoms including dizziness, headache, unusual tiredness, irritability, muscle tension, and nausea.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness; heartburn; irritability; nausea; nervousness; upset stomach.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; diarrhea; drowsiness; hearing loss; ringing in the ears; severe or persistent dizziness; severe or persistent stomach pain or heartburn; shakiness; trouble sleeping; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Aspirin/Caffeine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include agitation; anxiety; confusion; fever; hearing loss; lethargy; lightheadedness, especially upon standing; muscle twitching; nausea; rapid breathing; rapid or irregular heartbeat; ringing in the ears; seizures; shortness of breath; stomach pain; trouble sleeping; vomiting.
Store Aspirin/Caffeine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aspirin/Caffeine out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Aspirin/Caffeine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Promisec may be available in the countries listed below.
Omeprazole is reported as an ingredient of Promisec in the following countries:
International Drug Name Search
Bactroban® 2% Cream.
1g Cream contains: 21.5mg Mupirocin calcium equivalent to 20.0mg mupirocin.
For excipients, see Section 6.1.
Cream.
Bactroban Cream is presented as a white cream of homogeneous appearance.
Bactroban Cream is indicated for the topical treatment of secondarily infected traumatic lesions such as small lacerations, sutured wounds or abrasions (up to 10cm in length or 100cm2 in area), due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes.
Dosage
Adults/children/elderly
Three times a day for up to 10 days, depending on the response.
Patients not showing a clinical response within 3 to 5 days should be re-evaluated.
The duration of treatment should not exceed 10 days.
Children < 1 year
Mupirocin Cream has not been studied in infants under 1 year old and therefore it should not be used in these patients until further data become available.
Hepatic impairment: No dosage adjustment is necessary.
Renal impairment: No dosage adjustment is necessary.
Method of administration
A thin layer of cream should be applied to the affected area with a piece of clean cotton wool or gauze swab.
The treated area may be covered by a dressing.
Do not mix with other preparations, as there is a risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupirocin in the cream.
Hypersensitivity to mupirocin or any of the excipients (see section 6.1).
Should a possible sensitisation reaction or severe local irritation occur with the use of Bactroban Cream, treatment should be discontinued, the product should be washed off and appropriate therapy instituted.
As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms.
Bactroban Cream formulation is not suitable for intranasal use. For intranasal use, a separate presentation, Bactroban nasal ointment, is available.
Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the cream residues have been removed.
Bactroban Cream contains cetyl alcohol and stearyl alcohol. These inactive ingredients may cause local skin reactions (e.g. contact dermatitis).
No drug interactions have been identified.
Use in pregnancy:
Reproduction studies on mupirocin in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on its use during pregnancy, mupirocin should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.
Use in lactation:
There is no information on the excretion of mupirocin in milk. If a cracked nipple is to be treated, it should be thoroughly washed prior to breast feeding.
No adverse effects on the ability to drive or operate machinery have been identified.
Data from clinical trials was used to determine the frequency of very common to rare undesirable effects.
The following convention has been used for the classification of frequency:-
very common >1/10, common >1/100 and <1/10 , uncommon >1/1000 and <1/100,
rare >1/10,000 and <1/1000 , very rare <1/10,000.
Skin and subcutaneous tissue disorders:
Common: Application site hypersensitivity reactions including urticaria, pruritus, erythema, burning sensation, contact dermatitis, rash
Skin dryness and erythema have been reported in irritancy studies in volunteers.
The toxicity of mupirocin is very low. In the event of accidental ingestion of the cream symptomatic treatment should be given.
ATC classification
Properties
ATC-code : D06A X09, Antibiotics and chemotherapeutics for dermatological use.
Mode of Action
Mupirocin is an antibiotic produced through fermentation by Pseudomonas fluorescens. Mupirocin inhibits isoleucyl transfer-RNA synthetase, thereby arresting bacterial protein synthesis. Due to this particular mode of action and its unique chemical structure, mupirocin does not show any cross-resistance with other clinically available antibiotics.
Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higher concentrations reached when applied locally.
Activity
Mupirocin is a topical antibacterial agent showing in vivo activity against Staphylococcus aureus (including methicillin-resistant strains), S. epidermidis and beta-haemolytic Streptococcus species.
The in-vitro spectrum of activity includes but is not limited to the following bacteria which are most often implicated in skin infections:
- Staphylococcus aureus (including beta-lactamase-producing strains and methicillin resistant strains).
- Staphylococcus epidermidis (including beta-lactamase-producing strains and methicillin-resistant strains).
- Other coagulase-negative staphylococci (including methicillin-resistant strains).
- Streptococcus species.
Absorption
Systemic absorption of mupirocin through intact human skin is low although it may occur through broken/diseased skin. However, clinical trials have shown that when given systemically, it is metabolised to the microbiologically inactive metabolite monic acid and rapidly excreted.
Excretion
Mupirocin is rapidly eliminated from the body by metabolism to its inactive metabolite monic acid which is rapidly excreted by the kidney.
Pre-clinical effects were seen only at exposures which give no cause for concern for man under normal conditions of clinical use. Mutagenicity studies revealed no risks to man.
Xanthan gum, liquid paraffin, cetomacrogol 1000, stearyl alcohol, cetyl alcohol, phenoxyethanol, benzyl alcohol, purified water.
None known
18 months
Do not store above 25°C. Do not freeze.
Squeezable aluminium tubes with a screw cap containing 15 g of white cream.
Any product remaining at the end of treatment should be discarded.
Beecham Group plc
980 Great West Road, Brentford
Middlesex TW8 9GS
Trading as:
GlaxoSmithKline UK
Stockley Park West,
Uxbridge,
Middlesex, UB11 1BT
PL 00038/0372
28 October 1998
8th March 2010
POM
Nicorax may be available in the countries listed below.
Carvedilol is reported as an ingredient of Nicorax in the following countries:
International Drug Name Search
Ozlodip may be available in the countries listed below.
Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Ozlodip in the following countries:
International Drug Name Search
Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: N-Isopropyl-α-(2-methylhydrazino)-p-toluamide monohydrochloride
Molecular Formula: C16H22N2O3•HCl
CAS Number: 366-70-1
Brands: Matulane
Use under supervision of a qualified clinician experienced in therapy with antineoplastic agents.100
Use only when adequate treatment facilities for appropriate management of therapy and complications are available.100
Antineoplastic agent; a polyfunctional alkylating agent.100 b d
Treatment of stage III and IV Hodgkin’s disease.100 101
Used in various combination therapy regimens; comparative efficacy continually being evaluated.102 103 104
Used in combination with mechlorethamine, vincristine, and prednisone (known as the MOPP regimen) in an alternating schedule with the ABVD regimen (doxorubicin, bleomycin, vinblastine, and dacarbazine) for treatment of Hodgkin’s disease.101 102 103 104
Used in combination with bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, and prednisone (increased-dose BEACOPP regimen) for treatment of advanced Hodgkin’s disease.101 104
Use in other combination regimens for treatment of advanced Hodgkin’s disease being investigated.104
Treatment of brain tumors†.106
Used in combination with lomustine and vincristine (PCV) as adjuvant therapy following surgery and radiation therapy for malignant gliomas (e.g., anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma)†.101 107 108 109
Has been used as a component of combination chemotherapy regimens for treatment of intermediate-grade non-Hodgkin’s lymphomas†.101
Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.100 b
Individualize dosage according to clinical and hematologic response.100 b
Administer orally in single or divided doses.100 b
Has been administered IV† (IV preparation not commercially available in the US); however, produced a higher incidence of toxicity than oral therapy.b
Available as procarbazine hydrochloride; dosage expressed in terms of procarbazine.b
Dosage based on patient’s actual body weight; if patient is obese or has abnormal fluid retention (e.g., edema, ascites), use ideal body weight to calculate dosage.100
Consult published protocols for dosage of procarbazine and other chemotherapeutic agents and method and sequence of administration.100 b
Not definitely established; manufacturer recommends 50 mg/m2 daily for first week of therapy.100
Subsequently, 100 mg/m2 daily until maximum response obtained, unless hematologic or other toxicity occurs.100 (See Pediatric Patients: Dosage Modification for Toxicity and Contraindications for Continued Therapy, under Dosage and Administration.)
After maximum response attained, usual maintenance dosage is 50 mg/m2 daily.100
Interruption or discontinuance of the drug may be required in patients experiencing toxicity.100 Upon satisfactory recovery from toxicity, resume therapy at discretion of the clinician.100
If leukocyte count is <4000/mm3 or if platelet count is <100,000/mm3, interrupt therapy.100
If hemorrhage or bleeding tendencies develop, discontinue therapy.100 (See Hematologic Effects under Cautions.)
At onset of stomatitis, discontinue therapy immediately.100
If diarrhea occurs, discontinue therapy.100 (See GI Effects under Cautions.)
If manifestations of CNS toxicity occur (e.g., paresthesia, neuropathy, confusion), discontinue therapy.100 (See Pediatric Use and also see Nervous System Effects under Cautions.)
If hypersensitivity reaction occurs, discontinue therapy.100 (See Sensitivity Reactions under Cautions.)
Single-agent therapy: Initially, 2–4 mg/kg daily, in single or divided doses, for first week.100
Subsequently, 4–6 mg/kg daily until maximum response obtained, unless hematologic or other toxicity occurs.100 (See Adults: Dosage Modification for Toxicity and Contraindications for Continued Therapy, under Dosage and Administration.)
After maximum response attained, usual maintenance dosage is 1–2 mg/kg daily.100
Component of MOPP regimen: Usually, 100 mg/m2 daily on days 1–14 of a 28-day cycle.100 102 103
Interruption or discontinuance of the drug may be required in patients experiencing toxicity.100 Upon satisfactory recovery from toxicity, resume therapy at discretion of the clinician.100
Single-agent therapy: After satisfactory recovery from toxicity, may resume dosage at 1–2 mg/kg daily.100
If leukocyte count is <4000/mm3 or if platelet count is <100,000/mm3, interrupt therapy.100
If hemorrhage or bleeding tendencies develop, discontinue therapy.100 (See Hematologic Effects Under Cautions.)
At onset of stomatitis, discontinue therapy immediately.100
If diarrhea occurs, discontinue therapy.100 (See GI Effects under Cautions.)
If manifestations of CNS toxicity occur (e.g., paresthesia, neuropathy, confusion), discontinue therapy.100 (See Nervous System Effects under Cautions.)
If hypersensitivity reaction occurs, discontinue therapy.100 (See Sensitivity Reactions under Cautions.)
No special population dosage recommendations at this time.100 (See Hepatic Impairment and also see Renal Impairment under Cautions.)
Inadequate marrow reserve as demonstrated by bone marrow aspiration.100
Known hypersensitivity to procarbazine.100
Procarbazine possesses some MAO inhibitory activity; avoid concomitant use with certain food or prescription and OTC drugs.100 (See Specific Drugs, Foods, and Therapies under Interactions.)
Leukopenia, anemia, and thrombocytopenia occur frequently.100 Discontinue therapy if leukocyte count is <4000/mm3 or platelet count is <100,000/mm3.100 Consider possibility of inadequate marrow reserve in patients with leukopenia, thrombocytopenia, or anemia.100 (See Dosage Modification for Toxicity and Contraindications for Continued Therapy in Pediatric Patients and also in Adults under Dosage and Administration.)
Myelosuppression often occurs 2–8 weeks after beginning treatment.100 Leukopenia may require hospitalization for appropriate treatment to prevent systemic infection.100
Possible hemolysis and appearance of Heinz-Ehrlich inclusion bodies in erythrocytes.100 Hemorrhagic tendencies (e.g., petechiae, purpura, epistaxis, hemoptysis, hematemesis, hematuria, melena) reported.100 Discontinue therapy if bleeding or bleeding tendencies occur.100
If the patient received previous radiation or chemotherapy with myelosuppressive effects, delay procarbazine administration for ≥1 month.100 Perform successive bone marrow studies to determine when bone marrow recovery is sufficient to allow procarbazine therapy initiation.100
May cause fetal harm; teratogenicity demonstrated in animals.100 Avoid pregnancy during therapy.100 If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.100
Secondary malignancies (e.g., acute myeloid leukemia, lung cancer, malignant myelosclerosis) reported in patients receiving procarbazine in combination with other chemotherapy and/or radiation therapy.100
Increased risk of secondary lung cancer reported in patients receiving procarbazine in combination with tobacco products; discontinue tobacco use.100
Generalized allergic reactions reported. 100
If hypersensitivity reaction occurs, discontinue therapy.100
Photosensitivity reported.b
Severe nausea and vomiting occur frequently.100
Discontinue therapy if stomatitis (e.g., small ulceration or persistent soreness around the mouth) or diarrhea (frequent bowel movements or watery stools) occurs.100 (See Dosage Modification for Toxicity and Contraindications for Continued Therapy in Pediatric Patients and also in Adults under Dosage and Administration.)
Discontinue therapy if paresthesia, neuropathy, or confusion occurs.100
Possible mental depression, hallucinations, dizziness, headache, apprehension, nervousness, insomnia, nightmares, falling, unsteadiness, ataxia, footdrop, nystagmus, decreased reflexes, tremors, coma, confusion, and seizures.100 (See Pediatric Use under Cautions.)
Highly toxic drug; administer only under constant supervision of a qualified clinician experienced in cancer chemotherapy.100 When appropriate, initiate therapy with the patient hospitalized;100 carefully consider patient’s clinical and histologic diagnosis and hematologic, renal, and hepatic status.100 b
Monitor hematologic status carefully.100 Perform blood counts (hemoglobin, hematocrit, leukocyte and differential counts, reticulocyte and platelet determinations) prior to therapy and at least every 3–4 days thereafter.100 (See Hematologic Effects under Cautions.)
Perform urinalysis, serum transaminase, serum alkaline phosphatase, and BUN determinations prior to therapy and at least weekly thereafter.100
Category D.100 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Not known whether procarbazine is distributed into milk;100 discontinue nursing.100
Undue toxicity (i.e., coma, seizures, tremor) has occurred in a few pediatric patients.100 (See Nervous System Effects under Cautions.)
Individualize dosage; careful monitoring required.100
Possible increased incidence of toxicity.100 Consider initiating therapy with the patient hospitalized.100 (See Adequate Patient Evaluation and Monitoring and also see Major Toxicities under Cautions.)
Possible increased incidence of toxicity.100 Consider initiating therapy with the patient hospitalized.100 (See Adequate Patient Evaluation and Monitoring and also see Major Toxicities under Cautions.)
Leukopenia, anemia, thrombocytopenia, nausea, vomiting.100
Drug, Food, or Therapy | Interaction | Comments |
|---|---|---|
Alcohol | Possible disulfiram-like reactions100 | Alcohol should not be consumed during procarbazine therapy100 |
Antidepressants, tricyclics (e.g., amitriptyline, imipramine) | Potential serious and life-threatening serotonin syndromec | Avoid concomitant use100 b |
CNS depressants (antihistamines, barbiturates, hypotensive agents, opiates, phenothiazines) | Possible additive CNS depression100 | Use concomitantly with caution100 Avoid concomitant use with OTC preparations containing antihistamines. |
Food, tyramine-containing (e.g., bananas, cheese, caffeine, yogurt) | Potential for hypertensive reactionsc | Avoid food and drinks with high tyramine content 100 Consult specialized references on food constituents or a dietician for specific information on the tyramine content of foods and beveragesc |
Myelosuppressive agents | Possible additive myelosuppressive effects100 | An interval of ≥1 month without myelosuppressive therapy should elapse before initiating procarbazine;100 during this interval, perform bone marrow studies to determine when to initiate therapy100 |
Radiation therapy | Possible additive myelosuppressive effects100 | An interval of ≥1 month without radiation therapy should elapse before initiating procarbazine;100 during this interval, perform bone marrow studies to determine when to initiate therapy100 |
Sympathomimetic agents (e.g., ephedrine, phenylpropanolamine [no longer commercially available in the US]) | Potential for hypertensive reactionsc | Avoid concomitant usec |
Tobacco | Concomitant use may increase risk of secondary lung cancer100 | Discontinue tobacco use100 |
Rapidly and completely absorbed;100 peak plasma concentrations attained within 1 hour following oral administration.100
Oral administration may result in plasma concentrations similar to those achieved following IV administration of the drug (IV preparation not commercially available in the US).b
Readily crosses the blood-brain barrier; rapidly equilibrates between plasma and CSF following oral administration.100
Distributed into liver, kidneys, intestinal wall, and skin following IV administration.b
Not known whether procarbazine is distributed into milk.100
Metabolized principally in liver and kidneys.100
Excreted in urine as metabolites.100
IV: Approximately 10 minutes.100
Tight, light-resistant containers at 15–30°C (may be exposed to ≤40°C).b
Precise mechanism(s) of cytotoxic action unknown; may inhibit protein, RNA, and DNA synthesis by inhibiting transmethylation of methyl groups of methionine into t-RNA.100 b d
Cycle-phase nonspecific.d
Inhibits mitosis by prolonging the interphase of cell division and causing chromatid breaks in ascites carcinoma cells.b
May directly damage DNA; hydrogen peroxide formed during auto-oxidation of the drug may attack protein sulfhydryl groups contained in residual protein tightly bound to DNA.100
Cytotoxic effects limited to tissues with high rates of cellular proliferation; effects only evident in cells actively synthesizing DNA.b
Also has MAO inhibiting properties.100
Risk of bone marrow suppression, nausea, vomiting, and secondary malignancies.100
Importance of close medical supervision during therapy.100
Importance of avoiding alcoholic beverages and tobacco during therapy.100
Importance of avoiding foods with known high tyramine content such as wine, yogurt, ripe cheese, and bananas.100
Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy and to advise pregnant women of risk to the fetus.100
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs (e.g., antihistamines) and dietary or herbal supplements, as well as any concomitant illnesses.100
Importance of advising patients of other important precautionary information.100 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 50 mg (of procarbazine) | Matulane | Sigma-Tau |
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
100. Sigma-Tau Pharmaceuticals, Inc. Matulane (procarbazine hydrochloride) capsules prescribing information. Gaithersburg, MD; 2004 Feb.
101. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52.
102. Urba WJ, Longo DL. Hodgkin’s disease. N Engl J Med. 1992; 326:678-687. [IDIS 292239] [PubMed 1736106]
103. DeVita VT Jr, Hubbard SM. Hodgkin’s disease. N Engl J Med. 1993; 328:560-5. [IDIS 309839] [PubMed 8426624]
104. Adult Hodgkin lymphoma. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2008 Mar 3.
105. Food and Drug Administration. Prescription drug advertising; content and format for labeling of human prescription drugs. Fed Regist. 1979; 44:37434-67.
106. Green SB, Byar DP, Walker MD et al. Comparisons of carmustine, procarbazine, and high-dose methylprednisolone as additions to surgery and radiotherapy for the treatment of malignant glioma. Cancer Treat Rep. 1983; 67:121-32. [IDIS 168449] [PubMed 6337710]
107. Levin VA, Silver P, Hannigan J et al. Superiority of post-radiotherapy adjuvant chemotherapy with CCNU, procarbazine, and vincristine (PCV) over BCNU for anaplastic gliomas: NCOG 6G61 final report. Int J Radiat Oncol Biol Phys. 1990; 18:321-4. [PubMed 2154418]
108. Cairncross G, Macdonald D, Ludwin S et al. Chemotherapy for anaplastic oligodendroglioma. National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 1994; 12:2013-21. [IDIS 337224] [PubMed 7931469]
109. Olson JD, Riedel E, DeAngelis LM. Long-term outcome of low-grade oligodendroglioma and mixed glioma. Neurology. 2000; 54:1442-8. [IDIS 446653] [PubMed 10751254]
110. Department of Health and Human Services, Food and Drug Administration. Subpart B—Labeling requirements for prescription drugs and/or insulin. (21 CFR Ch. 1 [4-1-87 Ed.]). 1987:18-24.
b. AHFS drug information 2009. McEvoy GK, ed. Procarbazine. Bethesda, MD: American Society of Health-System Pharmacists, Inc; 2009:1217–20.
c. AHFS drug information 2009. McEvoy GK, ed. MAO inhibitors general statement. Bethesda, MD: American Society of Health-System Pharmacists, Inc; 2009:2331–6.
d. AHFS drug information 2009. McEvoy GK, ed. Antineoplastic agents general statement. Bethesda, MD: American Society of Health-System Pharmacists, Inc; 2009. From website: .
Adrovance may be available in the countries listed below.
Alendronic Acid is reported as an ingredient of Adrovance in the following countries:
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Adrovance in the following countries:
Colecalciferol is reported as an ingredient of Adrovance in the following countries:
International Drug Name Search
Generic Name: brinzolamide ophthalmic (brin ZOE la mide off THAL mik)
Brand Names: Azopt
Brinzolamide reduces the amount of fluid in the eye, which decreases pressure inside the eye.
Brinzolamide ophthalmic (for the eyes) is used to treat certain types of glaucoma and other causes of high pressure inside the eye.
Brinzolamide ophthalmic may also be used for other purposes not listed in this medication guide.
Before using this medication, tell your doctor if you are allergic to any drugs, or if you have narrow-angle glaucoma.
Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using brinzolamide ophthalmic. Do not use the medications at the same time.
Before using this medication, tell your doctor if you are allergic to any drugs, or if you have narrow-angle glaucoma.
Use brinzolamide ophthalmic exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.
Wash your hands before using the eye drops.
To apply the eye drops:
Tilt your head back slightly and pull down on the lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper. Squeeze out a drop and close your eye. Gently press your finger to the inside corner of the eye (near the nose) for about 1 minute to keep the liquid from draining into your tear duct.
If you use the drops in both eyes, repeat the steps above in your other eye. Also wait at least 10 minutes before using any other eye drops that your doctor has prescribed.
Tell your doctor right away if you have an eye infection, injury, or plan to have any type of eye surgery. You may need to stop using the medicine for a short time.
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.
An overdose of brinzolamide ophthalmic is not expected to produce life-threatening symptoms.
Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using brinzolamide ophthalmic. Do not use the medications at the same time.
swelling or redness of your eyelids;
eye redness, discomfort, or sensitivity to light;
drainage, crusting, or oozing of your eyes or eyelids;
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
pain in your upper stomach, jaundice (yellowing of your skin or eyes);
pale skin, easy bruising or bleeding; or
chest pain.
Less serious side effects may include:
blurred vision, double vision, drooping eyelid;
burning or stinging in your eye;
bitter or unusual taste in your mouth;
stomach or back pain;
dry eyes, feeling that something is in your eye;
headache; or
nausea, diarrhea.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Before using brinzolamide ophthalmic, tell your doctor if you are using any of the following drugs:
salicylates such as aspirin, Novasal, Doan's Extra Strength, Salflex, Tricosal, and others;
This list is not complete and there may be other drugs that can interact with brinzolamide ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: Azopt side effects (in more detail)
Amigrenex may be available in the countries listed below.
Sumatriptan is reported as an ingredient of Amigrenex in the following countries:
International Drug Name Search
Relieving symptoms of sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, and cough due to colds, upper respiratory infections, or allergies. It may also be used for other conditions as determined by your doctor.
Pseudoephedrine/Triprolidine/Codeine Liquid is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Pseudoephedrine/Triprolidine/Codeine Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Pseudoephedrine/Triprolidine/Codeine Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Triprolidine/Codeine Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Pseudoephedrine/Triprolidine/Codeine Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Pseudoephedrine/Triprolidine/Codeine Liquid.
When used for long periods of time or at high doses, Pseudoephedrine/Triprolidine/Codeine Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Pseudoephedrine/Triprolidine/Codeine Liquid stops working well. Do not take more than prescribed.
Some people who use Pseudoephedrine/Triprolidine/Codeine Liquid for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Pseudoephedrine/Triprolidine/Codeine Liquid suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, irritability); persistent trouble sleeping; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; trouble urinating or inability to urinate; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness; vision changes or blurred vision.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; cold and clammy skin; coma; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; unusually fast, slow, or irregular heartbeat; vomiting.
Store Pseudoephedrine/Triprolidine/Codeine Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Triprolidine/Codeine Liquid out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Pseudoephedrine/Triprolidine/Codeine Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Itorol may be available in the countries listed below.
Isosorbide Mononitrate is reported as an ingredient of Itorol in the following countries:
International Drug Name Search
Protaxil may be available in the countries listed below.
Proglumetacin dimaleate (a derivative of Proglumetacin) is reported as an ingredient of Protaxil in the following countries:
International Drug Name Search
Qvar 50 Aerosol 50 micrograms per actuation pressurised inhalation solution
Beclometasone Dipropionate 50 micrograms per metered (ex-valve) dose.
(The dose delivered from the mouthpiece is an average 37.5 micrograms).
For a full list of excipients, see section 6.1.
Pressurised inhalation, solution.
A colourless solution in a pressurised aluminium canister fitted with a metering valve and an actuator.
Qvar contains a propellant, which does not contain any chlorofluorocarbons (CFCs).
Prophylactic management of mild, moderate or severe asthma.
Qvar is for inhalation use only.
Patients should be instructed in the proper use of their inhaler, including rinsing out their mouth with water after use. Patients should be advised that Qvar may have a different taste and feel than a CFC inhaler.
NOTE: The recommended total daily dose of Qvar is lower than that for current beclometasone dipropionate CFC containing products and should be adjusted to the needs of the individual patient.
ADULT STARTING AND MAINTENANCE DOSE:
It is important to gain control of asthma symptoms and optimise pulmonary function as soon as possible. When patients' symptoms remain under satisfactory control, the dose should be titrated to the lowest dose at which effective control of asthma is maintained.
To be effective, inhaled Qvar must be used on a regular basis even when patients are asymptomatic.
THERAPY IN NEW PATIENTS SHOULD BE INITIATED AT THE FOLLOWING DOSAGES
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TRANSFERRING PATIENTS TO QVAR FROM A CFC-CONTAINING INHALER
The general approach to switching patients to Qvar involves two steps as detailed below. Specific guidance on switching well-controlled and poorly-controlled (symptomatic) patients is given below the table.
Step 1: Consider the dose of CFC containing beclometasone dipropionate product appropriate to the patient's current condition.
Step 2: Convert the CFC containing beclometasone dipropionate dose to the Qvar dose according to the table below.
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*CFC-BDP = CFC beclometasone dipropionate
1. Dosing in well-controlled patients with asthma
Patients with well-controlled asthma using beclometasone dipropionate CFC containing product should be switched to Qvar at a dose in accordance with the table above.
For example:
Patients on 2 puffs twice daily of CFC beclometasone dipropionate 100 micrograms would change to 2 puffs twice daily of Qvar 50 micrograms.
2. Dosing in poorly-controlled (symptomatic) patients with asthma
Patients with poorly-controlled asthma may be switched from CFC containing beclometasone dipropionate products to Qvar at the same microgram for microgram dose up to 800 micrograms daily. Comparative clinical studies have demonstrated that asthma patients achieve equivalent pulmonary function and control of symptoms with Qvar at lower total daily doses than with CFC containing beclometasone dipropionate products.
Alternatively the patient's current CFC containing beclometasone dipropionate dose can be doubled and this dose can be converted to the Qvar dose according to the table above.
Patients on budesonide inhalers may be transferred to Qvar as described for CFC containing beclometasone dipropionate products.
Patients on fluticasone inhalers may be transferred to the same total daily dose of Qvar up to 800 micrograms daily.
Once transferred to Qvar the dose should be adjusted to meet the needs of the individual patient.
The maximum recommended dose is 800 micrograms per day in divided doses.
The same total daily dose in micrograms from either Qvar 50 or Qvar 100 (a higher strength) aerosol provides the same clinical effect.
CHILDREN
There are no data to date on Qvar in children under 12 years of age, hence no definitive dosage recommendation can be made.
SPECIAL PATIENT GROUPS
No special dosage recommendations are made for elderly or patients with hepatic or renal impairment.
INSTRUCTIONS FOR USE
Qvar aerosol is recommended for those patients who have demonstrated consistent good technique with co-ordinating actuation and inhalation.
The patient should read the instruction leaflet before use.
Before first use of the inhaler, or if the inhaler has not been used for two weeks or more, prime the inhaler by releasing two puffs into the air.
Where a spacer is considered necessary for specific patient needs, Qvar aerosol can be used with AeroChamber Plus™ holding chamber, as the extrafine particle fraction is maintained.
Qvar delivers a consistent dose
- whether or not the canister is shaken by the patient
- without the need for the patient to wait between individual actuations
- regardless of storage orientation or periods without use of up to 14 days
- at temperatures as low as -10°C.
Hypersensitivity to beclometasone dipropionate or to any of the excipients.
To be effective, Qvar must be used by patients on a regular basis, even when patients do not have asthma symptoms. When symptoms are controlled, maintenance Qvar therapy should be reduced in a stepwise manner to the minimum effective dose. Inhaled steroid treatment should not be stopped abruptly. Patients with asthma are at risk of acute attacks and should have regular assessments of their asthma control including pulmonary function tests.
Qvar is not indicated for the immediate relief of asthma attacks. Patients therefore need to have relief medication (inhaled short-acting bronchodilator) available for such circumstances.
Qvar is not indicated in the management of status asthmaticus.
Severe asthma exacerbations should be managed in the usual way. Subsequently, it may be necessary to increase the dose of Qvar up to the maximum daily dose. Systemic steroid treatment may be needed and/or an antibiotic, if there is an infection.
Patients should be advised to seek medical attention for review of maintenance Qvar therapy if peak flow falls, symptoms worsen or if the short-acting bronchodilator becomes less effective and increased inhalations are required. This may indicate worsening asthma.
Patients who have received systemic steroids for long periods of time or at high doses, or both, need special care and subsequent management when being transferred to inhaled steroid therapy. Patients should have stable asthma before being given inhaled steroids in addition to the usual maintenance dose of systemic steroid. Withdrawal of systemic steroids should be gradual, starting about seven days after the introduction of Qvar therapy. For daily oral doses of prednisolone of 10mg or less, dose reduction in 1mg steps, at intervals of not less than one week is recommended. For patients on daily maintenance doses of oral prednisolone greater than 10mg, larger weekly reductions in the dose might be acceptable. The dose reduction scheme should be chosen to correlate with the magnitude of the maintenance systemic steroid dose.
Most patients can be successfully transferred to inhaled steroids with maintenance of good respiratory function, but special care is necessary for the first few months after the transfer, until the hypothalamic-pituitary-adrenal (HPA) system has sufficiently recovered to enable the patient to cope with stressful emergencies such as trauma, surgery or serious infections. Patients should, therefore, carry a steroid warning card to indicate the possible need to re-instate systemic steroid therapy rapidly during periods of stress or where airways obstruction or mucus significantly compromises the inhaled route of administration. In addition, it may be advisable to provide such patients with a supply of corticosteroid tablets to use in these circumstances. The dose of inhaled steroids should be increased at this time and then gradually reduced to the maintenance level after the systemic steroid has been discontinued. As recovery from impaired adrenocortical function, caused by prolonged systemic steroid therapy is slow, adrenocortical function should be monitored regularly.
Patients should be advised that they may feel unwell in a non-specific way during systemic steroid withdrawal despite maintenance of, or even improved respiratory function. Patients should be advised to persevere with their inhaled product and to continue withdrawal of systemic steroids, even if feeling unwell, unless there is evidence of HPA axis suppression.
Discontinuation of systemic steroids may also cause exacerbation of allergic diseases such as atopic eczema and rhinitis. These should be treated as required with topical therapy, including corticosteroids and/or antihistamines.
Beclometasone dipropionate, like other inhaled steroids, is absorbed into the systemic circulation from the lungs. Beclometasone dipropionate and its metabolites may exert detectable suppression of adrenal function. Within the dose range 100-800 micrograms daily, clinical studies with Qvar have demonstrated mean values for adrenal function and responsiveness within the normal range. However, systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important, therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.
Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than the recommended doses, may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Like other corticosteroids, caution is necessary in patients with active or latent pulmonary tuberculosis.
No interaction studies have been performed.
The potential risk of this product for humans is unknown.
Qvar
There is no experience of this product in pregnancy and lactation in humans, therefore the product should only be used if the expected benefits to the mother are thought to outweigh any potential risk to the foetus or neonate
Beclometasone dipropionate
There is inadequate evidence of safety in human pregnancy.
The use of beclometasone dipropionate in pregnancy requires that the possible benefits of the drug be weighed against the possible hazards. The drug has been in widespread use for many years without apparent ill consequence.
It is probable that beclometasone dipropionate is excreted in milk. However, given the relatively low doses used by the inhalation route, the levels are likely to be low. In mothers breast feeding their baby the therapeutic benefits of the drug should be weighed against the potential hazards to mother and baby.
Not relevant.
A serious hypersensitivity reaction including oedema of the eye, face, lips and throat (angioedema) has been reported rarely.
As with other inhaled therapy, paradoxical bronchospasm may occur after dosing. Immediate treatment with a short-acting bronchodilator should be initiated, Qvar should be discontinued immediately and an alternate prophylactic treatment introduced.
Systemic effects of inhaled corticosteroids may occur, particularly with high doses prescribed for prolonged periods. These include adrenal suppression, growth retardation in children, decrease in bone mineral density and the occurrence of cataract and glaucoma.
Commonly, when taking Qvar, hoarseness and candidiasis of the throat and mouth may occur. To reduce the risk of hoarseness and candida infection, patients are advised to rinse their mouth after using their inhaler.
Based on the MedDra system organ class and frequencies, adverse events are listed in the table below according to the following frequency estimate: very common (
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Acute overdosage is unlikely to cause problems. The only harmful effect that follows inhalation of large amounts of the drug over a short time period is suppression of HPA function. Specific emergency action need not be taken. Treatment with Qvar should be continued at the recommended dose to control the asthma; HPA function recovers in a day or two.
If excessive doses of beclometasone dipropionate were taken over a prolonged period a degree of atrophy of the adrenal cortex could occur in addition to HPA suppression. In this event the patient should be treated as steroid dependent and transferred to a suitable maintenance dose of a systemic steroid such as prednisolone. Once the condition is stabilised, the patient should be returned to Qvar by the method described above in section 4.4.
Pharmacotherapeutic group: Glucocorticoids, ATC Code: R03B A01
Qvar contains beclometasone dipropionate in solution in propellant HFA-134a resulting in an extrafine aerosol. The aerosol droplets are on average much smaller than the beclometasone dipropionate particles delivered by CFC-suspension formulations or dry powder formulations of beclometasone dipropionate. The extrafine particle fraction will be 60% ± 20% of the drug particles
Radio-labelled deposition studies in adults with mild asthma have demonstrated that the majority of drug (>55% ex-actuator) is deposited in the lung and a small amount (< 35% ex-actuator) is deposited in the oropharynx. These delivery characteristics result in equivalent therapeutic effects at lower total daily doses of Qvar, compared with CFC beclometasone dipropionate formulations.
Inhaled beclometasone dipropionate is now well established in the management of asthma. It is a synthetic glucocorticoid and exerts a topical, anti-inflammatory effect on the lungs, with fewer systemic effects than oral corticosteroids.
Comparative clinical studies have demonstrated that asthma patients achieve equivalent pulmonary function and control of symptoms with Qvar at lower total daily doses than CFC containing beclometasone dipropionate aerosol inhalers.
Pharmacodynamic studies in patients with mild asthma given Qvar for 14 days, have shown that there is a linear correlation among urinary free cortisol suppression, dose administered, and serum total-beclometasone levels obtained. At a daily dose of 800 micrograms Qvar, suppression of urinary free cortisol was comparable with that observed with the same daily dose of CFC containing beclometasone dipropionate, indicating a wider safety margin, as Qvar is administered at lower doses than the CFC product.
The pharmacokinetic profile of Qvar shows that the peak serum concentration for total- beclometasone (BOH) (total of any beclometasone OH and beclometasone dipropionate or monopropionate hydrolysed to beclometasone OH) after single and multiple doses is achieved after 30 minutes.
The value at the peak is approximately 2 nanograms/ml after a total daily dose of 800 micrograms and the serum levels after 100, 200 and 400 micrograms are proportional. The principal route of elimination of beclometasone dipropionate and its several metabolites is in the faeces. Between 10% and 15% of an orally administered dose is excreted in the urine, as both conjugated and free metabolites of the drug.
In both single dose and multiple dose pharmacokinetic studies, a dose of 200 micrograms of Qvar achieved comparable total-BOH levels, as a dose of 400 micrograms of CFC containing beclometasone dipropionate aerosol. This provided the scientific rationale for investigating lower total daily doses of Qvar to achieve the same clinical effect.
Pharmacokinetic studies with Qvar have not been carried out in any special populations.
In animal studies, propellant HFA-134a has been shown to have no significant pharmacological effects other than at very high exposure concentrations, then narcosis and a relatively weak cardiac sensitising effect were found. The potency of the cardiac sensitisation was less than that of CFC-11 (trichlorofluoromethane).
In studies to detect toxicity, repeated high dose levels of propellant HFA-134a indicated that safety margins based on systemic exposure would be of the order 2200, 1314 and 381 for mouse, rat and dog with respect to humans.
There are no reasons to consider propellant HFA-134a as a potential mutagen, clastogen or carcinogen judged from in vitro and in vivo studies including long-term administration by inhalation in rodents.
Studies of propellant HFA-134a administered to pregnant and lactating rats and rabbits have not revealed any special hazard.
In animals, systemic administration of relatively high doses can cause abnormalities of foetal development including growth retardation and cleft palate. There may therefore be a very small risk of such effects in the human foetus. However, inhalation of beclometasone dipropionate into the lungs avoids the high level of exposure that occurs with administration by systemic routes.
Safety studies with Qvar in rat and dog showed few, if any, adverse effects other than those normally associated with general steroid exposure including lymphoid tissue alterations such as reduction in thymus, adrenal and spleen weights. An inhalation reproductive study with this product in rats did not exhibit any teratogenic effects.
Propellant HFA-134a (Norflurane)
Ethanol.
Not applicable.
3 years
Do not store above 25°C. Protect from frost and direct sunlight.
The canister contains a pressurised liquid. Do not expose to temperatures higher that 50°C. Do not pierce the canister.
Pressurised aluminium canister closed with a metering valve containing either 100 or 200 actuations.
Not applicable.
Teva UK Limited
Brampton Road
Hampden Park
Eastbourne
East Sussex
BN22 9AG
United Kingdom
PL 00289/1371
2nd November 2009
11/05/2011
