Broncho-vaxom
Poland
Table of Contents
Warning! Keep the package leaflet! Information on the immediate packaging in a foreign language.
Broncho-Vaxom (Broncho-Vaxom for children)
3.5 mg, hard capsules
Lyophilized bacterial lysates
For use in children aged from 6 months to 12 years
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, 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. 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
- What you need to know 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 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. 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, you should discuss this with your doctor or
pharmacist.
If an allergic reaction to Broncho-Vaxom occurs, treatment must be discontinued immediately and the doctor must 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
The elderly population was widely represented in clinical studies with Broncho-Vaxom. No overall safety concerns were identified.
Renal impairment
Data on use in patients with renal impairment are limited.
Preclinical toxicity studies did not reveal any significant signs of nephrotoxicity 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.
Preclinical toxicity studies did not reveal any significant signs of hepatotoxicity 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 baby, 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 this medicine 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 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, i.e. the medicine is 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 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 acute phases of respiratory tract infections, the medicinal product may be used concomitantly with appropriate treatment methods.
If necessary, the prophylactic treatment cycle may be repeated.
Method of administration
Oral use.
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 recommended
Contact a doctor.
If you miss a 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 Broncho-Vaxom treatment
Do not stop treatment without consulting a doctor.
If you have any further questions about the use of this medicine, consult a doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine may cause adverse reactions, although not everybody will experience 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 rash, generalized rash, flushing (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, 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 immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions 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, 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 enables better assessment of the medicine's safety profile.
5. How to store Broncho-Vaxom
Keep this 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. These measures will help protect the environment.
6. Contents of the packaging 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 looks like and contents of the pack
Broncho-Vaxom is supplied as opaque capsules with a white body and blue cap.
Pack contents: 10 hard capsules (1 blister strip of 10 capsules in a cardboard box).
Pack contents: 30 hard capsules (3 blister strips of 10 capsules each in a cardboard box).
For further information, please contact the marketing authorisation holder 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:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Bulgaria, country of export: 20030170
Parallel Import Licence Number: 307/20