


Ask a doctor about a prescription for Bronho-vaxom
Broncho-Vaxom(Бронxо-Ваксом For adults)
Broncho-Vaxom and Бронxо-Ваксом За възрастни are different trade names for the same drug, written in Polish and Bulgarian.
Broncho-Vaxom is an immunostimulant medicine. It contains bacterial lysates that most commonly cause respiratory tract infections. In humans, the medicine stimulates cellular and humoral immunity mechanisms by activating macrophages, increasing the number of circulating T lymphocytes, and increasing the concentration of immunoglobulins secreted by the respiratory tract mucosa. The indications for using Broncho-Vaxom are as follows:
Before starting to take Broncho-Vaxom, you should discuss it with your doctor or pharmacist. If you experience an allergic reaction to Broncho-Vaxom, you should stop the treatment immediately and inform your doctor. It is not recommended to use Broncho-Vaxom to prevent pneumonia, as there are no clinical trial data confirming such an effect. Use in the elderly In clinical trials of Broncho-Vaxom, the elderly population was widely represented. No safety concerns were identified. Renal impairment Data on the use of Broncho-Vaxom in patients with renal impairment are limited. In preclinical toxicity studies, no signs of nephrotoxicity were observed in rats or dogs. Therefore, the use of Broncho-Vaxom in this patient group does not raise safety concerns. Hepatic impairment There are no available data on the use of Broncho-Vaxom in patients with hepatic impairment. In preclinical toxicity studies, no signs of hepatotoxicity were observed in rats or dogs. Therefore, the use of Broncho-Vaxom in this patient group does not raise safety concerns.
You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. So far, no interactions have been observed between Broncho-Vaxom and other medicines.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine. Pregnancy There are only limited data available on the use of Broncho-Vaxom in pregnant women. Animal studies have not shown any direct or indirect harmful effects on reproduction. As a precaution, it is recommended to avoid using Broncho-Vaxom during pregnancy. Breastfeeding No studies have been conducted to evaluate the use of Broncho-Vaxom in breastfeeding women. As a precaution, it is recommended to avoid using Broncho-Vaxom in breastfeeding women.
The medicine has no or negligible influence on the ability to drive and use machines.
This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, which means that the medicine is considered "sodium-free".
This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. Broncho-Vaxom is intended for oral use in adults. The recommended dose is: Prophylactic treatment cycle in case of recurrent respiratory tract infections: One hard capsule (7 mg for adults) per day on an empty stomach, for 10 consecutive days per month for 3 consecutive months. In case of acute phase of respiratory tract infections, the medicinal product may be used simultaneously with appropriate treatment methods. If necessary, the prophylactic treatment cycle can be repeated. Method of administration For oral use. If the patient cannot swallow the capsule, it can be opened and its contents can be poured into a suitable amount of water, fruit juice, or milk. The mixture dissolves under gentle stirring. Then, the mixture should be taken in its entirety within a few minutes and always stirred just before drinking.
You should contact your doctor.
You should not take a double dose to make up for a missed capsule. The next dose should be taken at the usual time.
You should not stop the treatment without consulting your doctor. If you have any doubts about taking the medicine, you should consult your doctor or pharmacist.
Like all medicines, Broncho-Vaxom can cause side effects, although not everybody gets them. The following side effects have been observed:
Headache, cough, diarrhea, abdominal pain, rash
Nausea, vomiting, hives, fever, fatigue Allergic reactions, including: rash in the form of red spots on the skin, rash covering the whole body, redness, swelling, including swelling of the eyelids or face, fluid accumulation in the feet, ankles, or legs, swelling, swelling of the face, itching, including itching all over the body, shortness of breath
Facial swelling, lips, tongue, throat, feet, and hands (angioedema) In case of skin reactions and respiratory system disorders, gastrointestinal disorders, you should stop taking Broncho-Vaxom and consult your doctor.
If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of the medicine.
Keep out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Store in a temperature below 25°C. Store in the original packaging. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
The active substance is OM-85 lyophilisate 40 mg, including lyophilized bacterial lysates: 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 propyl gallate (E 310) 84 micrograms sodium glutamate (E 621) 3.03 mg mannitol up to 40 mg Other ingredients of the medicine are corn starch, magnesium stearate, mannitol. The capsule shell contains: gelatin, indigo carmine (E 132), titanium dioxide (E 171).
Broncho-Vaxom is in non-transparent capsules with a blue body and blue cap. The pack contains 30 hard capsules (3 blisters of 10 each, in a cardboard box). For more detailed information, you should contact the marketing authorization holder or the parallel importer.
OM PHARMA S.A.
FLAVINE PHARMA FRANCE 3 voie d’Allemagne 13127 Vitrolles France
Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź
Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź CEFEA Sp. z o.o. Sp. komandytowa ul. Działkowa 56 02-234 Warszawa Pharma Innovations Sp. z o.o. ul. Jagiellońska 76 03-301 Warszawa Synoptis Industrial Sp. z o.o. ul. Szosa Bydgoska 58 87-100 Toruń IVA Pharm Sp. z o.o. ul. Drawska 14/1 02-202 Warszawa CANPOLAND SPÓŁKA AKCYJNA ul. Beskidzka 190 91-610 Łódź Marketing authorization number in Bulgaria, the country of export: 20030171 Parallel import authorization number: 321/20
[Information about the trademark]
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