Broncho-vaxom adults

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Broncho-Vaxom Adults / Broncho-Vaxom Children (Broncho-Vaxom® Adults / Broncho-Vaxom® Children)

Composition:

Active substance:

1 capsule of Broncho-Vaxom Adults contains standardized lyophilisate OM-85, comprising 7 mg of lyophilized bacterial lysates: Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis;

Excipients of the standardized lyophilisate OM-85: propyl gallate anhydrous (E 310), sodium glutamate (corresponding to anhydrous sodium glutamate), mannitol (E 421);

Other excipients: pregelatinized maize 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, comprising 3.5 mg of lyophilized bacterial lysates: Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis;

Excipients of the standardized lyophilisate OM-85: propyl gallate anhydrous (E 310), sodium glutamate (corresponding to anhydrous sodium glutamate), mannitol (E 421);

Other excipients: pregelatinized maize starch, magnesium stearate, mannitol (E 421); capsule shell: indigo carmine (E 132), titanium dioxide (E 171), gelatin.

Pharmaceutical form. Capsules.

Main physicochemical properties:

Broncho-Vaxom Adults: capsule size № 3; cap: opaque blue; body: opaque blue; capsule contents: light beige-colored powder;

Broncho-Vaxom Children: capsule size № 3; cap: opaque blue; body: opaque white; capsule contents: light beige-colored powder.

Pharmacotherapeutic group. Other agents acting on the respiratory system.

ATC code: R07AX.

Pharmacological properties.

Pharmacodynamics.

In animal studies, increased resistance to experimental infections has been reported, along with stimulation of macrophages and B-lymphocytes, and enhanced immunoglobulin secretion by mucosal cells of the respiratory tract.

In humans, an increase in circulating T-lymphocyte count and salivary IgA levels has been observed, as well as enhanced non-specific response to polyclonal mitogens and augmented mixed lymphocyte reaction.

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.

Due to the nature of the active substance—its multiple components and the lack of a suitable analytical method—standard pharmacokinetic studies are generally not feasible. To date, no experimental model exists.

Distribution

No data available.

Metabolism

No data available.

Elimination

No experimental model exists.

Preclinical data.

In numerous toxicity studies, no toxic effects have been observed.

Clinical characteristics.

Indications.

Prevention of recurrent respiratory tract infections.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients.

Interaction with other medicinal products and other forms of interactions.

Interaction of the drug with other medicinal products is currently unknown.

Special precautions for use

Broncho-Vaxom may cause hypersensitivity reactions. If allergic reactions or signs of intolerance occur, treatment should be discontinued immediately.

The product contains less than 1 mmol (23 mg) of sodium per capsule, i.e., it is practically sodium-free.

There are no clinical data demonstrating the ability of the medicinal product 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 insufficient animal studies on the effects of the product on pregnancy, embryonic development, fetal development, and/or postnatal development. The potential risk in humans is unknown. The medicinal product should be used with caution during pregnancy.

Specific studies on the use of the product during breastfeeding have not been conducted; data are lacking. The medicinal product should be used with caution during breastfeeding.

Ability to influence the speed of reactions when driving vehicles or operating machinery

Appropriate studies have not been conducted; however, it is unlikely that Broncho-Vaxom would affect the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

Adults and adolescents aged 12 years and older

Preventive treatment course: 1 capsule of Broncho-Vaxom Adult should be taken on an empty stomach once daily for 10 consecutive days each month, for 3 consecutive months.

Preventive treatment may 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 course: 1 capsule of Broncho-Vaxom Children should be taken on an empty stomach once daily for 10 consecutive days each month, for 3 consecutive months.

Preventive treatment may 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 may be opened and its contents emptied into a sufficient amount of water, fruit juice, or milk/formula. The capsule contents dissolve with gentle mixing.

Patients are advised to drink the entire prepared solution within a few minutes after preparation. The solution should be thoroughly mixed immediately before administration.

Children under 6 months of age

Clinical 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 for prophylactic purposes is not recommended.

Special Dosage Instructions

Patients with hepatic or renal impairment

Clinical data on the efficacy and safety of Broncho-Vaxom in these patient groups are lacking.

Children

The product is intended for use in children aged 6 months and older.

Overdose

No cases of overdose have been reported.

Adverse Reactions

The adverse effects identified are listed below according to the MedDRA classification by frequency and by system organ classes to which they belong. Frequencies are listed in decreasing order according to the following 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 not known (post-marketing reports, spontaneous reports from populations of undefined size, precise estimation not possible).

Immune system disorders

Uncommon: hypersensitivity (rash, urticaria, swelling, eyelid/face swelling, generalized pruritus, dyspnea).

Frequency not known: angioedema.

Nervous system disorders

Common: headache.

Respiratory, thoracic and mediastinal disorders

Common: cough.

Gastrointestinal disorders

Common: diarrhea, abdominal pain.

Uncommon: nausea, vomiting.

Skin and subcutaneous tissue disorders

Common: rash.

Uncommon: erythema, erythematous rash, generalized skin rash, pruritus.

General disorders

Uncommon: increased fatigue, peripheral edema.

Rare: pyrexia.

If persistent gastrointestinal or respiratory disturbances occur, treatment should be discontinued.

Shelf life

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 per cardboard box.

Prescription status

Prescription only.

Manufacturer/Marketing Authorization Holder

OM Pharma SA / OM Pharma SA

Manufacturer's address and location of business operations

22 rue du Bois-du-Lan, 1217 Meyrin, Switzerland /
22 rue du Bois-du-Lan, 1217 Meyrin, Switzerland