Broncho-vaxom for children
Poland
Table of Contents
Broncho-Vaxom dla dzieci
3.5 mg, granules in sachets
Active substance: lyophilized bacterial lysate
Please read carefully the leaflet before taking this 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 questions, please 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 another person, even if their symptoms are the same.
- If any adverse effects occur in the patient, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents:
- What Broncho-Vaxom dla dzieci is and what it is used for
- Important information before using Broncho-Vaxom dla dzieci
- How to use Broncho-Vaxom dla dzieci
- Possible side effects
- How to store Broncho-Vaxom dla dzieci
- Contents of the package and other information
1. What Broncho-Vaxom dla dzieci is and what it is used for
Broncho-Vaxom dla dzieci is an immunostimulant medicine. It contains a lysate of bacteria most commonly responsible for 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 dla dzieci are as follows:
- prevention of recurrent respiratory tract infections (RTIs) in children aged 6 months to 12 years.
2. Information before using Broncho-Vaxom dla dzieci
When not to use Broncho-Vaxom dla dzieci
- 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 dla dzieci, discuss it with your doctor or
pharmacist.
If an allergic reaction to Broncho-Vaxom dla dzieci occurs, treatment should be discontinued immediately and the doctor should be informed.
The use of Broncho-Vaxom dla dzieci in children for the prevention of pneumonia is not recommended,
as there are no clinical study data confirming such an effect.
Children
Clinical data on the use of Broncho-Vaxom dla dzieci in children under 6 months of age are limited.
As a precautionary measure, Broncho-Vaxom dla dzieci should not be given to children under 6 months of age.
Use in elderly patients
In clinical studies of Broncho-Vaxom dla dzieci, the elderly population was well represented. No safety concerns were identified.
Renal impairment
Data on use in patients with impaired renal function are limited.
In preclinical toxicity studies, no significant 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 impaired liver function.
In preclinical toxicity studies, no significant signs of hepatotoxicity were observed in rats or dogs. Therefore, use in this patient group does not raise safety concerns.
Broncho-Vaxom dla dzieci and other medicines
Tell 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.
To date, no interactions between Broncho-Vaxom dla dzieci and other medicines have been observed.
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
Available data on the use of Broncho-Vaxom dla dzieci in pregnant women are limited.
Animal studies have not shown any direct or indirect harmful effects on reproduction.
As a precautionary measure, the use of Broncho-Vaxom dla dzieci 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 dla dzieci should be avoided during breastfeeding.
Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive or operate machinery.
Broncho-Vaxom dla dzieci 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 dla dzieci
This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Broncho-Vaxom dla dzieci is intended for use in children aged 6 months to 12 years.
Recommended dosage:
Prophylactic treatment cycle for recurrent respiratory tract infections: One sachet (3.5 mg) 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 concurrently with appropriate treatment methods.
If necessary, the prophylactic treatment cycle may be repeated.
Method of administration
Oral use.
Empty the contents of the sachet into an appropriate amount of water, fruit juice, or milk/modified milk.
The mixture dissolves with gentle stirring.
The entire mixture should then be taken within a few minutes, and always stirred immediately before drinking.
Taking more Broncho-Vaxom dla dzieci than recommended
Contact your doctor.
If you miss a dose of Broncho-Vaxom dla dzieci
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse events observed during treatment were as follows:
Common (may occur in up to 1 in 10 patients):
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, 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, dyspnoea
Frequency not known (frequency cannot be estimated from the available data):
Headache, swelling of the face, lips, tongue, throat, feet and hands (angioedema)
In case of skin reactions and respiratory system disorders, gastrointestinal disturbances, discontinue use of Broncho-Vaxom dla dzieci and consult a doctor.
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 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
5. How to store the medicine Broncho-Vaxom dla dzieci
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package in the place marked "Expiry date" EXP. The expiry date refers to the last day of the
specified month.
Store below 25°C.
Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.
6. Contents of the pack and other information
What Broncho-Vaxom dla dzieci contains
One dose (sachet) contains:
OM-85 lyophilisate 20 mg
including lyophilised bacterial lysates:
Haemophilus influenzae, Streptococcus (Diplococcus) pneumoniae,
Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae,
Staphylococcus aureus, Streptococcus pyogenes and sanguinis 3.5 mg
(viridans), Moraxella (Branhamella/Neisseria) catarrhalis
propyl gallate (E 310) 42 micrograms
monosodium glutamate (E 621) 1.515 mg
mannitol up to 20 mg
The other ingredients are: pregelatinised starch, magnesium silicate, magnesium stearate, mannitol.
What Broncho-Vaxom dla dzieci looks like and contents of the pack
One sachet contains 240 mg of granules, including 3.5 mg of lyophilised bacterial lysate.
The granules are slightly beige in colour.
Pack containing 10 or 30 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
OMEDICAMED Unipessoal Lda
Avenida António Augusto de Aguiar nº 19 – 4º
1050-012 Lisboa
Portugal
Importer
FLAVINE PHARMA FRANCE
3 voie d’Allemagne,
13127 Vitrolles, France.
For further information, please contact your doctor or:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
Tel. 22 209 70 00, e-mail: [email protected]