Bronho-vaxom
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PATIENT LEAFLET: INFORMATION FOR THE USER
Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Broncho-Vaxom(Бронxо-Ваксом За деца)
3.5 mg, hard capsules
To be used in children from 6 months to 12 years of age
Active substance: lyophilized bacterial lysates
Broncho-Vaxom and Бронxо-Ваксом За деца are different trade names for the same medicine, written in Polish and Bulgarian.
You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
- You should keep this leaflet, so you can read it again if you need to.
- If you have any doubts, you should consult a doctor or pharmacist.
- This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
Table of contents of the leaflet
- 1. What is Broncho-Vaxom and what is it used for
- 2. Important information before taking 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 is Broncho-Vaxom and what is it used for
Broncho-Vaxom is a medicine that stimulates the immune system. It contains bacterial lysates that most commonly cause respiratory tract infections. In humans, the medicine stimulates cellular and humoral immune mechanisms by activating macrophages, increasing the number of circulating T lymphocytes, and increasing the concentration of immunoglobulins secreted by the mucous membrane of the respiratory tract. The indications for use of Broncho-Vaxom are as follows:
- prevention of recurrent respiratory tract infections (RTIs) in children from 6 months to 12 years of age.
2. Important information before taking Broncho-Vaxom
When not to take Broncho-Vaxom
- if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting to take Broncho-Vaxom, you should discuss it with your doctor or pharmacist. If an allergic reaction to Broncho-Vaxom occurs, treatment should be stopped immediately and the doctor should be informed. It is not recommended to use Broncho-Vaxom to prevent pneumonia, as there are no clinical trial data to support such use. Children: Data from clinical trials on the use of Broncho-Vaxom in children under 6 months of age are limited. As a precaution, it is not recommended to give Broncho-Vaxom to children under 6 months of age. Use in the elderly: In clinical trials, 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 concerns in terms of safety. 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 concerns in terms of safety.
Broncho-Vaxom and other medicines
You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. So far, no interactions have been observed between Broncho-Vaxom and other medicines.
Pregnancy, breastfeeding, and fertility
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 the use of Broncho-Vaxom in pregnant women. Breastfeeding: No studies have been conducted to assess the use of Broncho-Vaxom in breastfeeding women. As a precaution, it is recommended to avoid the use of Broncho-Vaxom in breastfeeding women.
Driving and using machines
The medicine has no or negligible influence on the ability to drive and use machines.
Broncho-Vaxom contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, which means it is considered "sodium-free".
3. How to take Broncho-Vaxom
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 children from 6 months to 12 years of age. The recommended dose is: Prophylactic treatment cycle in case of recurrent respiratory tract infections: One hard capsule (3.5 mg for children) 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 concomitantly with appropriate treatment methods. If necessary, the prophylactic treatment cycle can be repeated. Administration: Oral administration. If the patient or their child cannot swallow the capsule, it can be opened and its contents can be poured into a suitable amount of water, fruit juice, or milk/modified 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.
Overdose of Broncho-Vaxom
You should contact a doctor.
Missed dose of Broncho-Vaxom
You should not take a double dose to make up for a missed capsule. The next dose should be taken at the usual time.
Stopping treatment with Broncho-Vaxom
You should not stop treatment without consulting your doctor. If you have any doubts about taking the medicine, you should consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, Broncho-Vaxom can cause side effects, although not everybody gets them. The following side effects have been observed:
Common (may affect up to 1 in 10 people):
Headache, cough, diarrhea, abdominal pain, rash.
Uncommon (may affect up to 1 in 100 people):
Nausea, vomiting, hives, fever, fatigue. Allergic reactions, including: rash with 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 (peripheral edema), swelling, swelling of the face, itching, including itching all over the body, shortness of breath.
Frequency not known (frequency cannot be estimated from the available data):
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 a doctor.
Reporting of side effects
If you experience any side effects, including any 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 this medicine.
5. How to store Broncho-Vaxom
Keep out of the 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.
6. Contents of the pack and other information
What Broncho-Vaxom contains
The active substance is OM-85 lyophilisate 20 mg, containing 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 3.5 mg, propyl gallate (E 310) 42 micrograms, sodium glutamate (E 621) 1.515 mg, mannitol up to 20 mg. The other ingredients of the medicine are maize starch, magnesium stearate, mannitol. The capsule shell contains: gelatin, indigo carmine (E 132), titanium dioxide (E 171).
What Broncho-Vaxom looks like and contents of the pack
Broncho-Vaxom is available in non-transparent capsules with a white 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 consult the marketing authorization holder or parallel importer.
Marketing authorization holder in Bulgaria, the country of export:
OMEDICAMED Unipessoal Lda, Avenida António Augusto de Aguiar nº 19 – 4º, 1050-012 Lisbon, Portugal
Manufacturer:
FLAVINE PHARMA FRANCE, 3 voie d’Allemagne, 13127 Vitrolles, France
Parallel importer:
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
Repackaged by:
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw, Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw, 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 Warsaw, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź, Marketing authorization number in Bulgaria, the country of export: 20030170, Parallel import authorization number: 320/20
Date of approval of the leaflet: 29.09.2023
[Information about the trademark]
- Country of registration
- Prescription requiredNo
- Marketing authorisation holder (MAH)OMEDICAMED Unipessoal Lda
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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