Instructions for Broncho-Vaxom Children capsules 3.5 mg No. 30
Composition
active ingredient:
1 capsule of Broncho-Vaxom Adults contains standardized lyophilisate OM-85, which contains lyophilisate of bacterial lysates 7 mg: Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis;
excipients: standardized lyophilisate OM-85: anhydrous propyl gallate (E 310), sodium glutamate (corresponding to anhydrous sodium glutamate), mannitol (E 421);
other excipients: pregelatinized corn starch, magnesium stearate, mannitol (E 421); capsule shell: indigo carmine (E 132), titanium dioxide (E 171), gelatin;
1 capsule of Broncho-Vaxom Children contains standardized lyophilisate OM-85, which contains lyophilisate of bacterial lysates 3.5 mg: Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis;
excipients: standardized lyophilisate OM-85: anhydrous propyl gallate (E 310), sodium glutamate (corresponding to anhydrous sodium glutamate), mannitol (E 421);
other excipients: pregelatinized corn starch, magnesium stearate, mannitol (E 421); capsule shell: indigo carmine (E 132), titanium dioxide (E 171), gelatin.
Dosage form
Capsules.
Main physicochemical properties:
Broncho-Vaxom Adults: capsule No. 3; cap: opaque blue; body: opaque blue; capsule contents: light beige powder;
Broncho-Vaxom Children: capsule No. 3; cap: opaque blue; body: opaque white; capsule contents: light beige powder.
Pharmacotherapeutic group
Other agents acting on the respiratory system.
ATX code R07A X.
Pharmacological properties
Pharmacodynamics.
Animal studies have reported increased resistance to experimental infections, stimulation of macrophages and B lymphocytes, and increased secretion of immunoglobulins by cells of the respiratory mucosa.
In humans, an increase in the number of circulating T lymphocytes and salivary IgA, an increase in the nonspecific response to polyclonal mitogens, and an increase in the mixed lymphocytic reaction have been observed.
Pharmacokinetics.
Absorption
The active ingredient of OM-85 is a bacterial extract containing lyophilized fractions of 21 inactivated bacterial strains belonging to eight different species: Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis.
Given the origin of the active substance, a conventional pharmacokinetic study is impossible to conduct, largely due to the multiplicity of components and the lack of an appropriate analytical method. No experimental model exists to date.
Distribution
No data.
Metabolism
No data.
Elimination
There is no experimental model.
Preclinical data.
Numerous toxicity studies have not revealed any toxic effects.
Indication
Prevention of recurrent respiratory tract infections.
Contraindication
Hypersensitivity to the active substance or to any of the excipients.
Interaction with other medicinal products and other types of interactions
The interaction of the drug with other medications is currently unknown.
Application features
Broncho-Vaxom may cause hypersensitivity reactions. If allergic reactions or signs of intolerance are observed, treatment should be discontinued immediately.
This medicine contains less than 1 mmol (23 mg) sodium per capsule, i.e. essentially sodium-free.
There is no clinical trial data demonstrating the ability of Broncho-Vaxom to prevent the development of pneumonia. Therefore, the use of Broncho-Vaxom for the prevention of pneumonia is not recommended.
Use during pregnancy or breastfeeding
There are no adequate animal studies on the effects of the drug on pregnancy, embryonic development, fetal development and/or postnatal development. The potential risk for humans is unknown. During pregnancy, the drug is recommended to be used with caution.
No specific studies have been conducted on the use of the drug during breastfeeding, and no data are available. It is recommended to use the drug with caution during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
No relevant studies have been conducted, but it is unlikely that Broncho-Vaxom will affect the ability to drive vehicles and operate other mechanisms.
Method of administration and doses
Adults and adolescents aged 12 years and over
Preventive treatment course: Adults take 1 capsule of Broncho-Vaxom on an empty stomach daily for 10 consecutive days per month for 3 consecutive months.
Preventive treatment can be initiated during the acute phase of respiratory tract infections in combination with other treatment methods.
Children aged 6 months to 12 years
Preventive treatment can be initiated during the acute phase of respiratory tract infections in combination with other treatment methods.
Note: If a child has difficulty swallowing the capsule, it can be opened and the contents poured into a sufficient amount of water, fruit juice or milk/mixture. The contents of the capsule will dissolve with gentle stirring.
Patients are advised to drink the entire solution within a few minutes of preparation; the solution should be mixed well immediately before administration.
Children under 6 months of age
Clinical trial data on the use of Broncho-Vaxom Children in children under 6 months of age are limited. The use of Broncho-Vaxom Children in children under 6 months of age as a precautionary measure is not recommended.
Special dosage instructions
Patients with hepatic or renal insufficiency
There are no clinical data on the efficacy and safety of Broncho-Vaxom in these patients.
Children.
Used for children aged 6 months and over.
Overdose
No cases of overdose have been reported.
Adverse reactions
The identified adverse reactions are listed below according to the MedDRA classification by frequency of occurrence and by the system organ class to which they belong. The frequency is indicated in descending order of frequency using the following conventional categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000, including isolated cases); frequency unknown (post-marketing reports, spontaneous reports from a population of uncertain size, precise estimation not possible).
Immune system disorders
Uncommon: hypersensitivity (rash, urticaria, edema, eyelid/face edema, generalized itching, shortness of breath).
Frequency unknown: angioedema.
Nervous system disorders
Common: headache.
Respiratory, thoracic and mediastinal disorders
Common: cough.
Digestive system disorders
Common: diarrhea, abdominal pain.
Uncommon: nausea, vomiting.
Skin and subcutaneous tissue disorders
Common: rash.
Uncommon: erythema, erythematous rash, generalized skin rash, pruritus.
General violations
Uncommon: fatigue, peripheral edema.
Rare: pyrexia.
In case of persistent disorders of the digestive or respiratory system, treatment should be discontinued.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 capsules in a blister; 1 or 3 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
OM Pharma SA / OM Pharma SA
Location of the manufacturer and address of its place of business.
22 rue du Bois-du-Lan, 1217 Meiren, Switzerland /
22 rue du Bois-du-Lan, 1217 Meyrin, Switzerland
