Bronho-vaxom
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Patient Information Leaflet: User Information
Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Broncho-Vaxom (Бронхо-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 Бронхо-Ваксом за деца are different trade names for the same medicinal product, written in Polish and Bulgarian, respectively.
It is necessary to carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.
- The leaflet should be kept in order to be able to re-read it if necessary.
- In case of any doubts, the patient should consult a doctor or pharmacist.
- This medicinal product has been prescribed to a specific person. It should not be given to others. The medicinal product may harm another person, even if the symptoms of their disease are the same.
- If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform 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 an immunostimulant medicinal product. It contains bacterial lysates that most frequently cause respiratory tract infections.
In humans, the medicinal product 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 the 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 medicinal product (listed in section 6).
Warnings and precautions
Before starting treatment with Broncho-Vaxom, the patient should discuss it with their doctor or pharmacist.
In case of an allergic reaction to Broncho-Vaxom, treatment should be stopped immediately and the doctor informed.
Broncho-Vaxom should not be used to prevent pneumonia, as there are no clinical data supporting such use.
Children
Data on the use of Broncho-Vaxom in children under 6 months of age are limited.
As a precautionary measure, the use of Broncho-Vaxom is not recommended in children under 6 months of age.
Elderly patients
The elderly population was widely represented in clinical trials of Broncho-Vaxom. 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 safety concerns.
Hepatic impairment
No data are available 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 safety concerns.
Broncho-Vaxom and other medicinal products
The patient should inform their doctor or pharmacist about all medicinal products they are currently taking or have recently taken, as well as any medicinal products they plan to take.
No interactions have been identified between Broncho-Vaxom and other medicinal products.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicinal product.
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 is not recommended during pregnancy.
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 is not recommended during breastfeeding.
Driving and using machines
The medicinal product has no or negligible influence on the ability to drive and use machines.
Broncho-Vaxom contains sodium
This medicinal product contains less than 1 mmol of sodium (23 mg) per hard capsule, which is considered to be essentially sodium-free.
3. How to take Broncho-Vaxom
This medicinal product should always be taken exactly as instructed by the doctor or pharmacist. In case of doubts, the patient should consult their 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 for 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 an 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.
Method of administration:
Oral use.
If the patient or their child is unable to swallow the capsule, it can be opened and its contents poured into a suitable amount of water, fruit juice, or milk/modified milk.
The mixture dissolves under gentle stirring.
The mixture should be taken in its entirety within a few minutes and always stirred just before drinking.
Overdose of Broncho-Vaxom
The patient should contact their doctor.
Missed dose of Broncho-Vaxom
The patient 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
Treatment should not be stopped without consulting a doctor.
In case of doubts related to the use of the medicinal product, the patient should consult their doctor or pharmacist.
4. Possible side effects
Like all medicinal products, 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, treatment with Broncho-Vaxom should be stopped and medical advice sought.
Reporting side effects
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist.
Side effects can also be reported directly to the Department of Post-Marketing Surveillance 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 side effects, it is possible to gather more information on the safety of the medicinal product.
5. How to store Broncho-Vaxom
Keep out of the sight and reach of children.
Do not use this medicinal product 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.
Medicinal products should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.
6. Contents of the pack and other information
What Broncho-Vaxom contains
The active substance is OM-85 20 mg lyophilisate, containing:
Haemophilus influenzae, Streptococcus (Diplococcus) pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis (viridans), Moraxella (Branhamella/Neisseria) catarrhalis3.5 mg
Other ingredients are: propyl gallate (E 310), sodium glutamine, mannitol.
The other ingredients of the medicinal product are: maize starch, magnesium stearate, mannitol.
Capsule shell: 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.
Packaging: 10 hard capsules (1 blister of 10, in a cardboard box)
Packaging: 30 hard capsules (3 blisters of 10, in a cardboard box)
For more detailed information, the patient should contact the marketing authorization holder or the 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20030170
Parallel import authorization number:307/20
Date of approval of the leaflet: 27.09.2023
[Information about the trademark]
- Country of registration
- Prescription requiredYes
- 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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