Country: Մալթա
language: անգլերեն
source: Medicines Authority
LYOPHILIZED BACTERIAL, LYSATES
OM PHARMA S.A. R. da Industria, 2, 2610-088 Amadora, Lisboa, Portugal
R07AX
LYOPHILIZED BACTERIAL LYSATES 7 mg
CAPSULE
LYOPHILIZED BACTERIAL LYSATES 7 mg
POM
OTHER RESPIRATORY SYSTEM PRODUCTS
Withdrawn
2006-10-31
_ _ Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER BRONCHO-VAXOM ® ADULTS, 7 MG, CAPSULES, HARD BRONCHO-VAXOM ® CHILDREN, 3.5 MG, CAPSULES, HARD LYOPHILIZED BACTERIAL LYSATES READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Broncho-Vaxom is and what it is used for 2. What you need to know before you take Broncho-Vaxom 3. How to take Broncho-Vaxom 4. Possible side effects 5. How to store Broncho-Vaxom 6. Contents of the pack and other information 1. WHAT BRONCHO-VAXOM IS AND WHAT IT IS USED FOR Immunotherapy. Prevention of recurrent infections of the airways and acute infectious exacerbations of chronic bronchitis. Co-medication in the treatment of acute airway infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRONCHO-VAXOM DO NOT TAKE BRONCHO-VAXOM - if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Broncho-Vaxom. In the event of allergic reactions to Broncho-Vaxom, stop the treatment immediately and inform your doctor. CHILDREN On the basis of present knowledge, the administration of Broncho-Vaxom to children aged less than 6 months is not recommended. OTHER MEDICINES AND BRONCHO-VAXOM Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. No drug interaction is known up to now. PREGNANCY, BREAST-FEEDING AND FERTILITY If you are pregnant or breast-feeding, think you may be pregnant o read_full_document
_ _ Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BRONCHO-VAXOM ® Adults, 7 mg, capsules, hard BRONCHO-VAXOM ® Children, 3.5 mg, capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ _1 hard capsule for adults contains: _ _ _ Lyophilized bacterial lysates of Haemophilus influenzae, Streptococcus (Diplococcus) pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis (viridans), Moraxella (Branhamella/Neisseria) catarrhalis: 7 mg. _ _ _ _ _1 hard capsule for children contains: _ _ _ Lyophilized bacterial lysates of Haemophilus influenzae, Streptococcus (Diplococcus) pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis (viridans), Moraxella (Branhamella/Neisseria) catarrhalis: 3.5 mg. _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Broncho-Vaxom Adults Capsule, hard Opaque capsules with a blue capsule body and a blue cap. Broncho-Vaxom Children Capsule, hard Opaque capsules with a white capsule body and a blue cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Immunotherapy. Prevention of recurrent infections of the airways and acute infectious exacerbations of chronic bronchitis. Co-medication in the treatment of acute airway infections. _ _ Page 2 of 5 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Oral route. Adults _ _ _Pre_v_entive treatment and/or consolidation therapy_: 1 capsule daily on an empty stomach during 10 consecutive days per month for 3 months. _ _ _Treatment of acute episodes: _1 capsule daily on an empty stomach until disappearance of the symptoms (but for at least 10 days). In cases in which antibiotics are needed, the administration of Broncho-Vaxom Adults should be associated preferably from the start of therapy. Children (aged from 6 months to 12 years) The capsule can be opened and the content poured into a drink (water, fruit juice, milk, etc.). _Pre_v_entive treatment read_full_document