Broncho-vaxom
Poland
Table of Contents
Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Broncho-Vaxom (Broncho-Vaxom for children)
3.5 mg, hard capsules
For use in children aged from 6 months to 12 years
Active substance: lyophilized bacterial lysates
Broncho-Vaxom and Broncho-Vaxom for children are different trade names of the same medicinal product,
written in Polish and Bulgarian languages.
Please read the leaflet carefully before taking the medicine, as it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any doubts, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
- If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Leaflet contents
- What Broncho-Vaxom is and what it is used for
- Important information before using Broncho-Vaxom
- How to use Broncho-Vaxom
- Possible side effects
- How to store Broncho-Vaxom
- Contents of the pack and other information
1. What Broncho-Vaxom is and what it is used for
Broncho-Vaxom is an immunostimulant medicine. It contains bacterial lysates from the most common pathogens causing 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 respiratory mucosa.
The indications for use of Broncho-Vaxom are as follows:
- prevention of recurrent respiratory tract infections (RTIs) in children aged from 6 months to 12 years.
2. Important information before taking Broncho-Vaxom
When not to take Broncho-Vaxom
- if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Broncho-Vaxom, discuss it with your doctor or pharmacist.
If an allergic reaction to Broncho-Vaxom occurs, treatment must be discontinued immediately and the doctor should be informed.
The use of Broncho-Vaxom for the prevention of pneumonia is not recommended, as there are no clinical data confirming such an effect.
Children
Clinical data on the use of Broncho-Vaxom in children under 6 months of age are limited.
As a precautionary measure, Broncho-Vaxom should not be administered to children under 6 months of age.
Use in elderly patients
In clinical studies, elderly patients were well represented. No general safety concerns were identified.
Renal impairment
Data on the use in patients with renal impairment are limited.
In preclinical toxicity studies, no relevant signs of nephrotoxicity were observed in rats or dogs. Therefore, use in this patient group does not raise safety concerns.
Hepatic impairment
There are no available data on the use in patients with hepatic impairment.
In preclinical toxicity studies, no relevant signs of hepatotoxicity were observed in rats or dogs. Therefore, use in this patient group does not raise safety concerns.
Other medicines and Broncho-Vaxom
Tell your doctor or pharmacist about any other medicines you are currently taking, have recently taken, or plan to take.
No interactions between Broncho-Vaxom and other medicines have been observed to date.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Only limited data are 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 precautionary measure, the use of Broncho-Vaxom in pregnant women should be avoided.
Breastfeeding
No studies have been conducted to evaluate the use of this medicine in breastfeeding women.
As a precautionary measure, the use of Broncho-Vaxom should be avoided during breastfeeding.
Driving and operating machinery
Broncho-Vaxom has no effect or negligible effect on the ability to drive and operate machinery.
Broncho-Vaxom contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, i.e. the medicine is considered "sodium-free".
3. How to use Broncho-Vaxom
This medicine should always be taken as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
Broncho-Vaxom is intended for oral use in children aged 6 months to 12 years.
Recommended dose:
Prophylactic treatment cycle in cases of recurrent respiratory tract infections:
One hard capsule (3.5 mg for children) once daily on an empty stomach, for 10 consecutive days
per month over 3 consecutive months.
During the acute phase of respiratory tract infections, the medicinal product may be used
concurrently with appropriate treatment methods.
If necessary, the prophylactic treatment cycle may be repeated.
Administration method
Oral administration.
If the patient or their child cannot swallow the capsule, it may be opened and its contents poured
into a suitable amount of water, fruit juice, or milk/modified milk.
The mixture disperses with gentle stirring.
The mixture should then be taken entirely within a few minutes and should always be stirred
immediately before ingestion.
Taking more than the recommended dose of Broncho-Vaxom
Contact a physician.
Missed dose of Broncho-Vaxom
Do not take a double dose to make up for the missed capsule. Take the next dose at the usual time.
Stopping treatment with Broncho-Vaxom
Do not discontinue treatment without consulting the physician.
If in doubt about the use of this medicine, consult the physician or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed:
Common (may affect up to 1 in 10 patients):
Headache, cough, diarrhoea, abdominal pain, rash.
Uncommon (may affect up to 1 in 100 patients):
Nausea, vomiting, urticaria, fever, fatigue.
Allergic reactions, including: red skin rash, generalized rash, redness (erythema), swelling, including swelling of the eyelids or face, fluid accumulation in the feet, ankles or legs (peripheral oedema), swelling, facial swelling, itching, including generalized itching, shortness of breath.
Frequency not known (frequency cannot be estimated from the available data):
Swelling of the face, lips, tongue, throat, feet and hands (angioedema).
In case of skin reactions, respiratory disorders, or gastrointestinal disturbances, treatment with Broncho-Vaxom should be discontinued and medical advice should be sought.
Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store the medicine Broncho-Vaxom
Keep the medicine 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 stated month.
Store below 25°C.
Keep in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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
Excipients: propyl gallate (E 310), monosodium glutamate (E 621), mannitol, pregelatinized starch, magnesium stearate.
Capsule shell composition: gelatin, indigotine (E 132), titanium dioxide (E 171).
What Broncho-Vaxom capsules look like and contents of the pack
Broncho-Vaxom capsules are opaque, with a white body and a blue cap.
Pack containing 10 hard capsules (1 blister of 10 units, in a cardboard box).
Pack containing 30 hard capsules (3 blisters of 10 units each, in a cardboard box).
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in Bulgaria, country of export: 20030170
Parallel Import Licence Number: 199/20