Lyophilized Bacterial Lysates

Prevention of acute, sub-acute, chronic or recurrent infections of the upper respiratory tract (Common cold, Sinusitis, Pharyngitis, Epiglottitis, Laryngotracheitis, Otitis) and lower respiratory tract (Bronchitis, Bronchiolitis, Pneumonia, Acute Exacerbations in Chronic Obstructive Pulmonary Disease).

Each capsule contains-

• Active substance: Combination of bacterial lysates corresponding to lyophilized bacterial lysates of: Haemophilus influen- zae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp., pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis.
• Excipients of the capsules: Anhydrous propyl gallate, Monosodium glutamate (corre- sponding to anhydrous sodium glutamate), Pregelatinised starch, Magnesium stearate, Mannitol, color.: indigotin (E 132), titanium dioxide (E171).

Each sublingual tablet contains 50 mg Lyophilized Bacterial Lysate. Of this, 7 mg corresponds to-

• Staphylococcus aureus 6 billions
• Streptococcus pyogenes 6 billions
• Streptococcus viridans 6 billions
• Klebsiella pneumoniae 6 billions
• Klebsiella ozaenae 6 billions
• Haemophilus influenzae B 6 billions
• Neisseria (Moraxella) catarrhalis 6 billions
• Streptococcus (Diplococcus) pneumoniae 6 billions (1 billion unit of type TY1/EQ11; 1 billion unit of type TY2/EQ22; 1 billion unit of type TY3/EQ14; 1 billion unit of type TY5/EQ15; 1 billion unit of type TY8/EQ23; 1 billion unit of type TY47/EQ24) and
• 43mg Glycine for the lyophilization process.

Capsule:

• 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.

• Patients with hepatic or renal disorders: There are no clinical data on the efficacy and safety of Broncho-Vaxom in these patients.

Sublingual tablet:

• Children 3 years and above, adults and elderly: One sublingual tablet daily, to be dissolved under the tongue before meal for 10 consecutive days per month, for three consecutive months.

Interactions with other drugs is not known.

Hypersensivity to the active substance or auxiliary.

Sublingual tablet: In rare cases, respiratory, thoracic and mediastinal violations; skin and subcutaneous violations; general disorders, digestive disorders and local sublingual disturbances caused by the drug. In any case of violation, the treatment should be discontinued.

Capsule: 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 (21/10,000), 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.

Although toxic effects were observed in animals, not controlled studies were performed in pregnant women. For that reason, it is recommended to avoid the use during the first three months of confirmed or suspected pregnancy. During the period of fertility and lactation, special observations on the effect of the drug was carried out.

Lyophilized Bacterial Lysate 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 this can prevent pneumonia. Therefore, the administration of Lyophilized Bacterial Lysate to prevent pneumonia is not recommended.

No cases of overdose were observed.

Other antibacterial preparation

Store in a cool and dry place, protected from light.