Alfadel

Alfadel may be available in the countries listed below.

Ingredient matches for Alfadel

Alfacalcidol

Alfacalcidol is reported as an ingredient of Alfadel in the following countries:

• Greece

International Drug Name Search

Amoxicillina Mylan

Amoxicillina Mylan may be available in the countries listed below.

Ingredient matches for Amoxicillina Mylan

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicillina Mylan in the following countries:

• Italy

International Drug Name Search

Heparina Northia

Heparina Northia may be available in the countries listed below.

Ingredient matches for Heparina Northia

Heparin

Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Heparina Northia in the following countries:

• Argentina

International Drug Name Search

Metronidazol Domesco

Metronidazol Domesco may be available in the countries listed below.

Ingredient matches for Metronidazol Domesco

Metronidazole

Metronidazole is reported as an ingredient of Metronidazol Domesco in the following countries:

• Vietnam

International Drug Name Search

Cobaltamin-S

Cobaltamin-S may be available in the countries listed below.

Ingredient matches for Cobaltamin-S

Cobamamide

Cobamamide is reported as an ingredient of Cobaltamin-S in the following countries:

• Japan

International Drug Name Search

Eformoterol

Eformoterol may be available in the countries listed below.

Ingredient matches for Eformoterol

Formoterol

Eformoterol (BAN) is known as Formoterol in the US.

International Drug Name Search

Glossary

BAN	British Approved Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Envios-FB

Envios-FB may be available in the countries listed below.

Ingredient matches for Envios-FB

Kaolin

Kaolin is reported as an ingredient of Envios-FB in the following countries:

• Indonesia

Pectin

Pectin is reported as an ingredient of Envios-FB in the following countries:

• Indonesia

International Drug Name Search

Sulmycin

Sulmycin may be available in the countries listed below.

Ingredient matches for Sulmycin

Gentamicin

Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Sulmycin in the following countries:

• Austria


• Germany

International Drug Name Search

Doraplax

Doraplax may be available in the countries listed below.

Ingredient matches for Doraplax

Ibuprofen

Ibuprofen is reported as an ingredient of Doraplax in the following countries:

• Brazil

International Drug Name Search

Nitradisc

Nitradisc may be available in the countries listed below.

Ingredient matches for Nitradisc

Nitroglycerin

Nitroglycerin is reported as an ingredient of Nitradisc in the following countries:

• Argentina


• Brazil


• Luxembourg


• Portugal


• Spain

International Drug Name Search

Clavobay

Clavobay may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Clavobay

Amoxicillin

Amoxicillin is reported as an ingredient of Clavobay in the following countries:

• France

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Clavobay in the following countries:

• Austria


• Belgium


• Italy


• Netherlands


• Portugal


• Sweden

Clavulanate

Clavulanic Acid is reported as an ingredient of Clavobay in the following countries:

• France


• Netherlands


• Portugal


• Sweden

Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Clavobay in the following countries:

• Austria


• Belgium


• Italy

International Drug Name Search

bacillus of calmette and guerin vaccine, live Intradermal

ba-SILL-us of KAL-met and GARE-in VAX-een, lyve

Commonly used brand name(s)

In the U.S.

• BCG Vaccine

In Canada

• Bcg Vaccine Freeze Dried

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Vaccine

Uses For bacillus of calmette and guerin vaccine, live

Bacillus Calmette-Guérin (BCG) vaccine is given by injection to help prevent tuberculosis (TB). TB is a serious disease that can cause severe illness. It is spread by close contact with people who already have TB, such as people living in the same house. Some infected people do not appear to be sick, but they can still spread TB to others. BCG vaccine does not provide 100% protection. Therefore it is important to avoid people with TB, even if you have received the vaccine.

BCG vaccine is to be administered only by or under the direct supervision of a doctor.

Before Using bacillus of calmette and guerin vaccine, live

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bacillus of calmette and guerin vaccine, live, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bacillus of calmette and guerin vaccine, live or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

BCG vaccine has been used widely in children, and it has not been reported to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of BCG vaccine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving bacillus of calmette and guerin vaccine, live, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using bacillus of calmette and guerin vaccine, live with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aclarubicin


• Adalimumab


• Aldesleukin


• Altretamine


• Amonafide


• Amsacrine


• Asparaginase


• Azacitidine


• Azathioprine


• Bleomycin


• Broxuridine


• Busulfan


• Capecitabine


• Carboplatin


• Carmustine


• Certolizumab Pegol


• Chlorambucil


• Cisplatin


• Cladribine


• Cyclophosphamide


• Cytarabine


• Cytarabine Liposome


• Dacarbazine


• Dactinomycin


• Daunorubicin


• Daunorubicin Citrate Liposome


• Decitabine


• Docetaxel


• Doxifluridine


• Doxorubicin Hydrochloride


• Doxorubicin Hydrochloride Liposome


• Edatrexate


• Eflornithine


• Epirubicin


• Estramustine


• Etanercept


• Etoposide


• Everolimus


• Fingolimod


• Floxuridine


• Fludarabine


• Fluorouracil


• Fotemustine


• Gallium Nitrate


• Gemcitabine


• Golimumab


• Hydroxyurea


• Idarubicin


• Ifosfamide


• Irinotecan


• Lomustine


• Mechlorethamine


• Melphalan


• Mercaptopurine


• Methotrexate


• Mitolactol


• Mitomycin


• Mitotane


• Mitoxantrone


• Mycophenolic Acid


• Oxaliplatin


• Paclitaxel


• Pegaspargase


• Pentostatin


• Pipobroman


• Pirarubicin


• Plicamycin


• Procarbazine


• Raltitrexed


• Rilonacept


• Rituximab


• Sirolimus


• Streptozocin


• Tacrolimus


• Teceleukin


• Tegafur


• Temsirolimus


• Teniposide


• Thioguanine


• Thiotepa


• Topotecan


• Treosulfan


• Trimetrexate


• Trofosfamide


• Uracil Mustard


• Ustekinumab


• Vinblastine


• Vincristine


• Vincristine Liposome


• Vindesine


• Vinorelbine

Using bacillus of calmette and guerin vaccine, live with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept


• Leflunomide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of bacillus of calmette and guerin vaccine, live. Make sure you tell your doctor if you have any other medical problems, especially:

• Fever—If an infection is present, the chance of side effects from BCG vaccine may be increased

• Immunity problems—BCG vaccine may not work properly in persons with decreased natural immunity; also, the risk of side effects from BCG vaccine may be increased.

• Widespread skin infections

Proper Use of bacillus of calmette and guerin vaccine, live

Dosing

The dose of bacillus of calmette and guerin vaccine, live will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of bacillus of calmette and guerin vaccine, live. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

bacillus of calmette and guerin vaccine, live Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

More common

• Accumulation of pus


• peeling or scaling of the skin


• sores at place of injection


• sores at different sites of the skin


• swollen lymph glands

Rare

• Cough


• fever


• increase in bone pain


• skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: bacillus of calmette and guerin vaccine, live Intradermal side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More bacillus of calmette and guerin vaccine, live Intradermal resources

• Bacillus of calmette and guerin vaccine, live Intradermal Side Effects (in more detail)
• Bacillus of calmette and guerin vaccine, live Intradermal Use in Pregnancy & Breastfeeding
• Bacillus of calmette and guerin vaccine, live Intradermal Drug Interactions
• Bacillus of calmette and guerin vaccine, live Intradermal Support Group
• 0 Reviews for Bacillus of calmette and guerin vaccine, live Intradermal - Add your own review/rating

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Bromax Tablets

brompheniramine maleate

Dosage Form: tablet, extended release
Bromax Tablets

DESCRIPTION

Each white, dye free, Bromax Tablet for oral administration contains:

Brompheniramine Maleate  ..............  11 mg

Formulated in a specially prepared base which provides prolonged activity suitable for B.I.D. dosing.

Bromax Tablets contain ingredients of the following therapeutic class: Antihistamine.

Brompheniramine Maleate is 2-Pyridinepropanamine, γ-(4- bromophenyl)-N,N-dimethyl-, (±)-, (Z)-2-butenedioate (1:1) and has the following structural formula:

C16H19BrN2 • C4H4O4        M.W. 435.31

INACTIVE INGREDIENTS

Colloidal silicon dioxide, Eudragit, lactose monohydrate, magnesium stearate (veg.), methylcellulose, microcrystalline cellulose, povidone, silicified microcrystalline cellulose and stearic acid.

CLINICAL PHARMACOLOGY

Brompheniramine maleate is classified as an alkylamine antihistamine. This class is among the most active histamine antagonists and is generally effective in relatively low doses. Alkylamines cause a lesser degree of drowsiness and sedation than the phenothiazine and ethanolamine antihistamines and hence may be more suitable for daytime use. It should be noted however that patients taking alkylamine antihistamines may experience some degree of drowsiness and should be cautioned accordingly.

INDICATIONS AND USAGE

Bromax is indicated for the temporary relief of symptoms associated with seasonal and perennial allergic rhinitis and vasomotor rhinitis.

CONTRAINDICATIONS

This product is contraindicated  in patients with hypersensitivity to antihistamines, in nursing mothers, in patients receiving monoamine oxidase inhibitor (MAOI) therapy (see Drug Interactions section), or in patients with narrow angle glaucoma, urinary retention, peptic ulcer and in patients during an asthmatic attack.

WARNINGS

Caution should be exercised in patients with hyperthyroidism, increased intraocular pressure and prostatic hypertrophy.

Patients sixty (60) years and older may demonstrate an increased response to this drug, both in therapeutic effect and in the incidence of adverse reactions. A reduction in dosage may be more appropriate for these patients. Antihistamines may cause drowsiness or excitability, particularly in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur.

PRECAUTIONS

General

Antihistamines have an atropine-like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension.

Information for Patients

Patient consultation should include the following information regarding proper use of this medication:

• Do not take more medication than the amount recommended.

• Take medication with food, water, or milk to minimize gastric irritation.

• Swallow sustained release dosages whole; do not crush tablets.

• Do not drive or operate machinery if drowsiness or dizziness occurs.

• Do not ingest alcoholic beverages, monoamine oxidase inhibitors (MAOI), or CNS depression-producing medications (hypnotics, sedatives, tranquilizers) while taking this medication.

• If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; do not double doses.

• This medication should be stored in a tight, light-resistant container as described in the USP/NF, with a child resistant closure, and at temperatures between 20°- 25°C (68°- 77°F). See USP Controlled Room Temperature.

• Keep all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Caution patients about the signs of potential side effects, especially:

• Anticholinergic effects clumsiness or unsteadiness; severe drowsiness; severe dry mouth, nose, or throat; flushing or redness of face; shortness of breath or troubled breathing;

• Blood dyscrasias – sore throat and fever, unusual bleeding or bruising, unusual tiredness or weakness;

• Fast or irregular heart beat;

• Psychotic episodes;

• Tightness in chest.

DRUG & OR LABORATORY TEST INTERACTIONS

Antihistamines may interfere with diagnostic test results for skin tests using allergen extracts.

Drug Interactions

• MAOIs and Tricyclic Antidepressants - may prolong and intensify the anticholinergic (drying) effects of antihistamines.

• CNS Depressants - concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals and humans.

Pregnancy

Teratogenic Effects

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. This product should be used during pregnancy only if the potential benefits to the mother justify the potential risks to the infant.

Nonteratogenic Effects

Antihistamines should not be used in the third trimester of pregnancy because newborns and premature infants may have severe reactions to them, such as convulsions.

Nursing Mothers

It is not known whether this drug is excreted in human milk. However, certain antihistamines are known to be excreted in human milk. Because of the higher risks of antihistamines for infants generally and for newborns and prematures in particular, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Do not give this product to children under 12 years of age except under the advice and supervision of a physician.

Geriatric Use

Confusion, dizziness, sedation, hypotension, hyperexcitability, and anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), may be more likely to occur in geriatric patients taking antihistamines. Demonstrate safe use of a short-acting antihistamine before use of a sustained action formulation in elderly patients.

ADVERSE REACTIONS

The physician should be alert to the possibility of any of the adverse reactions which have been observed with antihistaminic drugs. These include: drowsiness; confusion; restlessness; nausea; vomiting; drug rash; vertigo; palpitation; anorexia; dizziness; dysuria due to vesicle sphincter spasm; headache, insomnia; anxiety; tension; weakness; tachycardia; angina; sweating; blood pressure elevation; mydriasis; gastric distress; abdominal cramps; central nervous system stimulation; circulatory collapse.

OVERDOSAGE

Signs and Symptoms:

Overdosage with antihistamines may cause hallucinations, convulsions or possible death, especially in infants and children. Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

Recommended General Treatment:

In the event of overdosage, emergency treatment should be started immediately. Since the action of sustained release products may continue for as long as 12 hours, treatment of overdosage should be directed toward reducing further absorption and supporting the patient for at least that length of time.

Since there is no specific antidote for antihistamine overdose, treatment is symptomatic and supportive with possible utilization of the following:

• Induction of emesis (syrup of ipecac recommended); however, precaution against aspiration is necessary, especially in infants and children.

• Gastric lavage (isotonic or 0.45% sodium chloride solution) if patient is unable to vomit within three hours of ingestion.

• Saline cathartics (milk of magnesia) are sometimes used.

• Vasopressors to treat hypotension. However, epinephrine should not be used since it may further lower blood pressure.

• Oxygen and intravenous fluids.

• Precaution against the use of stimulants (analeptic agents) is recommended because they may cause seizures.

• Short-acting barbiturates, diazepam, or paraldehyde, may be administered to control seizures.

• Hyperpyrexia, especially in children, may require treatment with tepid water sponge bath or a hypothermic blanket.

• Apnea is treated with ventilatory support.

DOSAGE AND ADMINISTRATION

Adults and children over 12 years of age: One tablet twice daily (B.I.D.).

Not recommended for children under 12 years of age.

HOW SUPPLIED

Bromax is supplied as white, capsule shaped tablets debossed "POLY / 911" on one side, and “plain” on the opposite side. Available in bottles of 100 tablets, NDC 50991-911-01

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage and Handling

Dispense in tight, light-resistant containers as described in the USP/NF, with a child resistant closure.

Store at 20°- 25°C (68°- 77°F). See USP Controlled Room Temperature.

Rx Only

Manufactured for:

Poly Pharmaceuticals, Inc.

Mobile, AL 36619

Iss. 09/09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: Container Label

BROMAX  brompheniramine maleate  tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50991-911 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 11 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   EUDRAGIT RS 30   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   HYPROMELLOSE 2208 (4000 CPS)   CELLULOSE, MICROCRYSTALLINE   POVIDONE K30   STEARIC ACID

Product Characteristics Color WHITE Score 2 pieces Shape CAPSULE Size 14mm Flavor Imprint Code POLY;911 Contains

Packaging # NDC Package Description Multilevel Packaging 1 50991-911-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		12/01/2009

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Registrant - Poly Pharmaceuticals, Inc. (198449894)

Establishment
Name	Address	ID/FEI	Operations
Sovereign Pharmaceuticals, LLC		623168267	MANUFACTURE

Revised: 03/2010Poly Pharmaceuticals, Inc.

More Bromax Tablets resources

• Bromax Tablets Side Effects (in more detail)
• Bromax Tablets Dosage
• Bromax Tablets Use in Pregnancy & Breastfeeding
• Bromax Tablets Drug Interactions
• Bromax Tablets Support Group
• 0 Reviews for Bromaxs - Add your own review/rating

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