Lyophilized Bacterial Lysates

Broncho-Vaxom is indicated as

Immunotherapy.

Prevention of recurrent respiratory tract infections and acute infective exacerbations of chronic bronchitis.

In animals, increased resistance to experimental infections, stimulation of macrophages and B lymphocytes as well as an increase in immunoglobulins secreted by the respiratory mucosal cells have been reported. In humans, an increase in the rate of circulating T lymphocytes, in salivary IgA, in the non-specific response to polyclonal mitogens and in the mixed lymphocyte reaction have been observed. Absorption: The active ingredient of OM-85 is a bacterial extract comprising lyophilised fractions of 21 inactivated bacterial strains belonging to eight different species: Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis. Due to the nature of the product, a conventional pharmacokinetic study cannot be performed, mainly because of the multiplicity of components and the lack of a suitable analytical method. No experimental model is currently available. Distribution, Metabolism, Elimination: No data available.

Adults and adolescents aged over 12 : The prophylactic treatment cycle for recurrent respiratory tract infections is 1 capsule Broncho-Vaxom Adults daily on an empty stomach during 10 consecutive days per month for 3 consecutive months. Broncho-Vaxom is not indicated for the treatment of acute respiratory infections but instead for the prevention of their recurrence. Prophylactic treatment can be initiated during the acute phase of respiratory tract infections, in combination with other treatments. Children aged from 6 months to 12 years : The prophylactic treatment cycle for recurrent respiratory tract infections is: one capsule of Broncho-Vaxom Children daily, to be taken on an empty stomach, for 10 consecutive days per month, over 3 consecutive months. Broncho-Vaxom is not indicated for the treatment of acute respiratory infections but instead for the prevention of their recurrence. Prophylactic treatment can be initiated during the acute phase of respiratory tract infections in combination with other treatments. Note : If the child has difficulty swallowing the capsule, it can be opened and the content poured into a sufficient quantity of water, fruit juice or milk. The mixture will dissolve with gentle stirring. Patients are advised to drink the entire mixture within a few minutes and to stir it well just before drinking. Patients with hepatic or renal disorders : There are no clinical data on the efficacy and safety of Broncho-Vaxom in these patients. Children aged under 6 months : Limited data from clinical studies are available on the use of Broncho-Vaxom in children under 6 months of age. As a precautionary measure, the use of Broncho-Vaxom in children under 6 months of age is not recommended.

Interactions with other drugs is not known.

Hypersensitivity to the active substance or to any of the excipients in accordance with the composition.

The identified undesirable effected are listed below according to the MedDRA classification, depending on their frequency and the system organ classes concerned. The frequencies are indicated in descending order in accordance with the following convention:

• Very common (≥ 1/10)
• Common (≥1/100 to <1/10)
• Uncommon (≥1/1,000 to <1/100)
• Rare (≥1/10,000), including isolated cases

Not known (reported after authorization). Reported voluntarily by a population of undetermined size, it is not possible to provide a viable estimate.

Immune system disorders : Uncommon: hypersensitivity (rash, urticarial, swelling, swelling of the eyelids/face, generalized pruritus, dyspnea). Not known: angioedema Nervous system disorders : Common: headaches Respiratory, thoracic and mediastinal disorders : Common: coughing Gastrointestinal disorders : Common: diarrhea, abdominal pain. Uncommon: nausea, vomiting Skin and subcutaneous tissue disorders : Common: rash. Uncommon: erythema, erythematous rash, general skin rash, pruritus General disorders : Uncommon: fatigue, peripheral swelling. Rare: pyrexia In cases of persistent gastrointestinal or respiratory disorders, treatment should be discontinued. If you notice any side effects, contact your doctor, pharmacist. This is particularly important in regard to side effects that are not listed in this package leaflet.

There is limited clinical data regarding use in pregnant women. Animal studies have not shown any direct or indirect toxicity affecting pregnancy, embryonic development, foetal development and/or post-natal development. As a precautionary measure, it is preferable to avoid the use of Broncho-Vaxom during pregnancy. Regarding breast-feeding, no specific studies have been conducted and no data have been reported. Caution is advised when breast-feeding.

Broncho-Vaxom may cause hypersensitivity reactions. If allergic reactions or signs of intolerance occur, treatment should be stopped immediately. No data from clinical studies are available to demonstrate that the use of Broncho-Vaxom can prevent pneumonia. Therefore, the administration of Broncho-Vaxom to prevent pneumonia is not recommended.

No cases of overdose were observed.

Store in its original package, out of sight and reach of children. Broncho-Vaxom has a shelf life of 5 years. Do not store above 30°C. Do not use this medicinal product after the expiry date which is stated on the container after 'EXP'.