Broncho-vaxom
Poland
Table of Contents
Warning! Keep the package leaflet! Information on the immediate packaging in a foreign language.
Broncho-Vaxom, 3.5 mg, hard capsules
For use in children aged from 6 months to 12 years
Active substance: lyophilised bacterial lysates
Please read the leaflet carefully before taking this medicine, as it contains
important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, 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 or pharmacist. See section 4.
Table of contents of the leaflet
- 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 package and other information
1. What Broncho-Vaxom is and what it is used for
Broncho-Vaxom is an immunostimulating agent. 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 using Broncho-Vaxom
When not to use 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 this with your doctor or
pharmacist.
If an allergic reaction to Broncho-Vaxom occurs, treatment should 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 precaution, Broncho-Vaxom should not be administered to children under 6 months of age.
Use in elderly patients
The elderly population was widely represented in clinical studies with Broncho-Vaxom. No general safety concerns were identified.
Renal impairment
Data on 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 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
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions between Broncho-Vaxom and other medicines have been reported to date.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Available data on the use of Broncho-Vaxom in pregnant women are limited.
Animal studies did not show 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 the 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 has a 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 and is therefore considered "sodium-free".
3. How to use Broncho-Vaxom
This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Broncho-Vaxom is intended for oral use in children aged 6 months to 12 years.
Recommended dose:
Prophylactic treatment cycle in the case of recurrent respiratory tract infections:
One hard capsule (3.5 mg in the case of 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 medicine may be used concurrently with appropriate treatment methods.
If necessary, the prophylactic treatment cycle may be repeated.
Method of administration
Oral administration.
If the patient or their child cannot swallow the capsule, it may be opened and the contents mixed with a suitable amount of water, fruit juice, or milk/modified milk.
The mixture dissolves with gentle stirring.
The mixture should then be taken entirely within a few minutes and should always be mixed immediately before consumption.
Taking more Broncho-Vaxom than prescribed
Contact a doctor.
Missed dose of Broncho-Vaxom
Do not take a double dose to make up for a missed capsule. Take the next dose at the usual time.
Stopping Broncho-Vaxom treatment
Do not stop treatment without consulting a doctor.
If in doubt about how to use this medicine, consult a doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed:
Common (may occur in up to 1 in 10 patients):
Headache, cough, diarrhoea, abdominal pain, rash.
Uncommon (may occur in up to 1 in 100 patients):
Nausea, vomiting, urticaria, fever, fatigue.
Allergic reactions, including: red skin spots, generalized rash, redness (erythema), swelling, including swelling of the eyelids or face, fluid accumulation in the feet, ankles or legs (peripheral oedema), oedema, facial swelling, itching, including generalized itching, dyspnoea.
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 immediately.
Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. 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 181C, 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 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 stated month.
Do not store above 25°C. Store 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. 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,
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.
Other components of the medicine are: simethicone emulsion (dimethicone, anhydrous colloidal silica), sodium
chloride, propyl gallate (E 310), sodium glutamate, pregelatinized starch, magnesium stearate, mannitol.
Capsule shell: gelatin, indigotine (E 132), titanium dioxide (E 171).
What Broncho-Vaxom capsules look like and contents of the pack
Broncho-Vaxom is an opaque capsule with a white body and blue cap.
Pack size: 10 hard capsules (1 blister of 10 units, in a cardboard box).
Pack size: 30 hard capsules (3 blisters of 10 units each, in a cardboard box).
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Austria, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Austria, country of export: 2-00002
Parallel Import Licence Number: 70/25