Broncho-vaxom
Poland
Table of Contents
Warning! Keep the package leaflet! Information on the immediate packaging in a foreign language.
Broncho-Vaxom (Broncho Vaxom), 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 are different trade names for the same medicinal product.
Please read carefully the information contained in this leaflet before taking the medicine, as it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- 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. It may harm someone else, 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 is Broncho-Vaxom and what it is used for
- Important information before taking Broncho-Vaxom
- How to take Broncho-Vaxom
- Possible side effects
- How to store Broncho-Vaxom
- Contents of the pack and other information
1. What is Broncho-Vaxom and what it is used for
Broncho-Vaxom is an immunostimulant medicine. It contains bacterial lysates from bacteria most commonly 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, consult 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 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, administration of Broncho-Vaxom is not recommended in children under 6 months of age.
Use in elderly patients
The elderly population was well represented in clinical studies with Broncho-Vaxom. No safety concerns have been identified.
Renal impairment
Data on the use of Broncho-Vaxom in patients with renal impairment are limited.
In preclinical toxicity studies, no specific 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 of Broncho-Vaxom in patients with hepatic impairment.
In preclinical toxicity studies, no specific 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 if the patient is taking, has recently taken or might take any other medicines.
No interactions between Broncho-Vaxom and other medicines have been observed 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 her doctor or pharmacist before using 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 Broncho-Vaxom in breastfeeding women.
As a precautionary measure, the use of Broncho-Vaxom should be avoided during breastfeeding.
Driving and operating machinery
This medicine 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 exactly as directed by a doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
Broncho-Vaxom is intended for oral use in children aged 6 months to 12 years.
Recommended dosage:
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, for 3 consecutive months.
In 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
emptied into 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 recommended
Contact your doctor.
If you forget to take Broncho-Vaxom
Do not take a double dose to make up for the missed capsule. Take the next dose at the usual time.
Stopping Broncho-Vaxom
Do not stop treatment without consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed:
Common (may affect up to 1 in 10 people):
Headache, cough, diarrhoea, abdominal pain, rash
Uncommon (may affect up to 1 in 100 people):
Nausea, vomiting, urticaria, fever, fatigue
Allergic reactions, including: red skin patches, 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 available data):
Swelling of the face, lips, tongue, throat, feet and hands (angioedema)
In case of skin reactions and respiratory, gastrointestinal disorders, discontinue use of Broncho-Vaxom and consult a doctor.
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.
By reporting adverse reactions, more information on the safety of this medicine can be collected.
5. How to store 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.
No special temperature storage conditions are required. Store in the original packaging to protect from light.
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,
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 ingredients are: propyl gallate (E 310), sodium glutamate, mannitol, pregelatinized starch,
magnesium stearate.
Capsule shell: gelatin, indigo carmine (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 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 further detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Italy, 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 by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Italy, country of export: 026029037
Parallel Import Licence Number: 8/25