Інструкція із застосування BRONKO VAXOM
Зміст інструкції
BRONCHO VAXOM Adults 7 mg hard capsules
BRONCHO VAXOM Children 3.5 mg hard capsules
BRONCHO VAXOM Children 3.5 mg granules in sachet
Lyophilized bacterial lysate
Read this leaflet carefully before taking this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What BRONCHO VAXOM is and what it is used for
- 2. What you need to know before you take 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 a preparation that works by stimulating the body to produce antibodies (proteins that protect it against germs that cause infectious diseases).
BRONCHO VAXOM is used in adults to prevent recurrent respiratory infections.
BRONCHO VAXOM is used in children and adolescents (aged between 1 and 17 years) to prevent recurrent infections (number of episodes higher than those that normally occur in that age group) of the upper airways.
If you do not feel better or if you feel worse, please consult your doctor.
2. What you need to know before taking BRONCHO VAXOM
Do not take BRONCHO VAXOM
- If you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6).
- If the child is under 1 year of age.
- If you suffer from autoimmune diseases (diseases of the immune system that react against organs and tissues of your own body).
- If you have acute intestinal infections.
Warnings and precautions
Consult your doctor or pharmacist before taking/giving BRONCHO VAXOM to the child.
- If you/the child develops a fever, especially at the beginning of treatment, stop taking BRONCHO VAXOM and consult your doctor. If you develop a high fever above 39°C (see section 4 “Possible side effects”), stop treatment and do not resume it. The doctor will assess whether this fever is related to taking the medicine or to the underlying condition of you/your child.
- If you/the child is taking other medicines with nonspecific immunomodulatory activity such as those containing bacterial extracts, do not take/give the child BRONCHO VAXOM as well.
- In some cases, the onset of asthma attacks has been observed in predisposed patients after taking medicines containing bacterial extracts. In this case, BRONCHO VAXOM adults/children should no longer be taken.
- If you/the child has an allergic reaction. Immediately stop taking BRONCHO VAXOM and consult your doctor (see section 4 “Possible side effects”). Treatment with BRONCHO VAXOM should not be resumed.
- The use of BRONCHO VAXOM for the prevention of pneumonia is not recommended because there is no data from clinical studies demonstrating such an effect.
- BRONCHO VAXOM is not indicated for the treatment of acute respiratory infections but exclusively for the prevention of recurrences; however, it is not necessary to discontinue recurrence prophylaxis of respiratory infections during the treatment of an ongoing respiratory infection.
Children
Do not give BRONCHO VAXOM to children under 1 year of age.
Other medicines and BRONCHO VAXOM
Tell your doctor or pharmacist if you/the child is taking, has recently taken or
may take any other medicine.
No interaction studies have been conducted with other medicines or vaccines.
The immune response may be inhibited in subjects with congenital or acquired immunodeficiency, undergoing
immunosuppressive therapy or with corticosteroids.
BRONCHO VAXOM with food and drink
See section 3 How to take BRONCHO VAXOM.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with milk
mother, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Data relating to the use of BRONCHO VAXOM in pregnant women are limited. Studies
on animals do not indicate any direct or indirect harmful effects regarding reproductive toxicity.
As a precautionary measure, it is preferable to avoid the use of BRONCHO VAXOM during pregnancy.
Breastfeeding
No specific studies have been conducted regarding breastfeeding and no data are available. Therefore, as a
precautionary measure, it is preferable to avoid the use of the product during breastfeeding.
Fertility
BRONCHO VAXOM has not shown effects on fertility
Driving and operating machinery
BRONCHO VAXOM does not or negligibly influences the ability to drive vehicles or operate
machinery.
Broncho Vaxom contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
3. How to take BRONCHO VAXOM
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Adults and adolescents over 12 years of age:
One hard capsule (7 mg) daily on an empty stomach, for 10 consecutive days in a month, for 3 months
consecutively.
The prophylactic treatment cycle can be repeated, if necessary.
Use in children aged between 1 year and 12 years
One hard capsule or 1 sachet (3.5 mg) daily on an empty stomach, for 10 consecutive days in a month, for
3 consecutive months.
The prophylactic treatment cycle can be repeated, if necessary.
Method of administration
Oral
The contents of the sachet should be poured into a beverage (water, fruit juice, milk/formula) before
administration.
If you or the child cannot swallow the capsule, it can be opened and its contents can be
poured into an adequate amount of water, fruit juice, milk/formula, as for the sachet formulation.
The mixture dissolves by gently stirring it. Then take the entire mixture within a few minutes and
always shake it just before drinking.
If you take more BRONCHO VAXOM than you should
If you have taken too much BRONCHO VAXOM, contact your doctor or go to hospital
immediately.
If you forget to take BRONCHO VAXOM
Do not take a double dose to make up for a missed dose.
If you stop taking BRONCHO VAXOM
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/the child experience
- stomach and intestinal disorders
- long-lasting respiratory disorders
- allergic reactions stoptreatment. If you/the child experience skin reactions stoptreatment, as they may be a symptom of an allergic reaction.
Other side effects reported for BRONCHO VAXOM are listed below according to frequency:
common (may affect up to 1 in 10 people)
- headache
- cough
- diarrhoea
- abdominal pain
- skin rash uncommon (may affect up to 1 in 100 people)
- allergic reactions (erythematous rash, generalized rash, erythema, edema, eyelid edema, facial edema, peripheral edema, swelling, facial swelling, itching, generalized itching, dyspnea)
- urticaria
- fatigue rare (may affect up to 1 in 1,000 people)
- fever not known (frequency cannot be estimated based on available data)
- rapid swelling of the skin and mucous membranes (angioedema)
- vomiting
- nausea
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store BRONCHO VAXOM
Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the pack after SCAD.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
InformationWhatcontainsBRONCHO
VAXOM
BRONCHO VAXOM Adults 7 mg hard capsules
- The active ingredients contained in a hard capsule are 7 mg of OM-85 lyophilized bacterial lysate of Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp.ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella)catarrhalis
- The other ingredients are Pregelatinized corn starch, mannitol, anhydrous propyl gallate (E310), anhydrous sodium glutamate, magnesium stearate. Capsule shell composition: gelatin; titanium dioxide (E 171), indigotin (E 132).
BRONCHO VAXOM Children 3.5 mg hard capsules
- The active ingredients contained in a hard capsule are 3.5 mg of OM-85 lyophilized bacterial lysate of Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp.ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella)catarrhalisThe other ingredients are Pregelatinized corn starch, mannitol, anhydrous propyl gallate (E310), anhydrous sodium glutamate, magnesium stearate. Capsule shell composition: gelatin; titanium dioxide (E 171), indigotin (E 132).
BRONCHO VAXOM Children 3.5 mg granules in sachet
- The active ingredients contained in a sachet are 3.5 mg of OM-85 lyophilized bacterial lysate of Haemophilus influenzae, Streptococcus pneumoniae. Klebsiella pneumoniae ssp. pneumoniae and ssp.ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella)catarrhalis
- The other ingredients are pregelatinized corn starch, mannitol, magnesium silicate ,anhydrous propyl gallate (E310), anhydrous sodium glutamate, magnesium stearate.
Description of the appearance of BRONCHO VAXOM and contents of the pack
BRONCHO VAXOM 7 mg hard capsules are presented as opaque capsules, with a blue body and cap,
containing a powder from white to light beige.
It is available in packs of 10 and 30 hard capsules.
BRONCHO VAXOM 3.5 mg hard capsules are presented as opaque capsules, with a white body and
blue cap, containing a powder from white to light beige.
It is available in packs of 10 and 30 hard capsules.
BRONCHO VAXOM 3.5 mg granules in sachet are presented as light beige granules. It is
available in packs of 10 and 30 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
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
Exclusive distributor for sale in Italy:
Aziende Chimiche Riunite Angelini Francesco
A.C.R.A.F. - S.p.A. - viale Amelia, 70
00181 Rome, Italy

- Країна реєстрації
- Лікарська формаHard capsule, 7 MG
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до BRONKO VAXOMЛікарська форма: Powder and solvent for injectable solution, 0,5 MLДіюча речовина: haemophilus influenzae B, combinations with toxoidsВиробник: SANOFI WINTHROP INDUSTRIEПотрібен рецептЛікарська форма: Injectable suspension in pre-filled syringe, 0.5MLДіюча речовина: meningococcus B, multicomponent vaccineВиробник: GLAXOSMITHKLINE VACCINES S.R.L.Рецепт не потрібенЛікарська форма: Injectable suspension, 0.5 MLДіюча речовина: pertussis, purified antigen, combinations with toxoidsВиробник: GLAXOSMITHKLINE S.P.A.Рецепт не потрібен
Аналоги BRONKO VAXOM в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог BRONKO VAXOM у Польща
Аналог BRONKO VAXOM у Україна
Лікарі онлайн щодо BRONKO VAXOM
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на BRONKO VAXOM онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
BRONKO VAXOM потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
BRONKO VAXOM виробляється компанією OMEDICAMED UNIPESSOAL LDA.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування BRONKO VAXOM з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати BRONKO VAXOM у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною () включають AKTIB, BEXSERO, BOOSTRIX. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















