Broncho - VAXOM . 3,5 mg. 30 capsules

CHILDREN / ADULT

Immunotherapy and prevention of infections of the respiratory system

INGREDIENTS:

Broncho-vaksom is immunotherapy and preventive product.

One capsule for children include:

Active substance: standardized lyophilisate bacterial lnzati 20 mg * 17.5 mg from Conti excipients and 3,5 mg bacterial lysates of the following types: I lemophilus influenzae type Ü, Streptococcus pneumoniae (type 1, type 2, type 3 and type 47) Klebsiella pneumoniae subsp. pneumoniae (2 strains) Klebsiella pneumoniae subsp. ozaenae, Staphylococcus aureus (6 strains), Streptococcus pyogenes Streptococcus viridans (3 strains), Branhamella catarrhalis (3 strains)

Other ingredients: Modified corn starch (nrezhelatinnzirana) - 110,000 mg Magnesium Silicate - 45,000 mg Magnesium stearate - 3,000 mg Propyl gallate - 0,042 mg Sodium glutamate -1,515 mg Mannitol - up to 240,000 mg * Capsule (average weight 50,00 mg): Indigotine - 0,01 mg Titanisv dioxide - 1,00 mg Gelatin-to 50,00 mg

  Composition of ink: Shellac - 65.10-3 mg Vegetable carbon - 18.I0-3 mg / capsule for adults: Active substance: standardized lyophilisate from bacterial lysates 40 mg ** of which 17.5 mg excipients and 7 mg of bacterial lysates the following 

Haemophilus influenzae type b, Streptococcus pneumoniae (type 1, type 2, type 3 and type 47), Klebsiella pneumoniae subsp. pneumoniae (2 strains) Klebsiella pneumoniae subsp. ozaenae,. Staphylococcus aureus (6 strains), Streptococcus pyogenes Streptococcus viridans (3 strains), Branhamella catarrhalis (3 strains)

Excipients

Modified corn starch

(Pregelatinized) - 110,000 mg

Magnesium silicate - 45,000 mg 

Magnesium stearate - 3,000 mg

Propyl gallate - 0,084 mg

Glutamate - 3,030 mg

Mannitol - up to 240,000 mg

 Capsule (average weight 50,00 mg):

Indigotine - 0,03 mg

Titanium dioxide - 1,00 mg

Gelatin - to 50,00 mg

  Composition of ink:

Shellac - 65.10-3 mg

Vegetable carbon -18.10-3 mg

PHARMACEUTICAL FORM

Hard capsules.

PROPERTIES / Mode of Action

Broncho-vaksom stimulate natural defenses and increase resistance to respiratory infections. This effect is demonstrated by testing active protection for the stimulation of macrophages and increase in circulating T-lymphocytes and immunoglobulins sekretornnte in the mucosa of the respiratory patishta.Predklinichni sa Safety Data: Toxicological studies show no toxic effects.

INDICATIONS

Immunotherapy. Prevention of recurrent respiratory tract infectious exacerbations of chronic bronchitis. Supporting the management of acute respiratory infections. Broncho-vaksom recommended as adjunctive therapy for specifically:

 Acute and chronic bronchitis

 Angina, tonsillitis, pharyngitis, laryngitis

  Rhinitis, sinusitis and otitis

 Infections resistant to common antibiotics

  Bacterial complications of viral respiratory infections, especially in children and the elderly.

CONTRAINDICATIONS

Known hypersensitivity to any component of Broncho-vaksom.

DOSAGE AND ADMINISTRATION

Preventive treatment and / or supportive therapy: 1 capsule daily fasting for 10 consecutive days, three months. Treatment during the acute episode pa: 1 capsule daily, fasting, until the symptoms disappear, but at least 10 consecutive days. When necessary and antibiotic therapy, treatment started simultaneously with Broncho-vaksom. Children pa aged 6 months to 12 years: same regimen, but is half the dose (capsules for children). Note: Broncho-vaksom capsules for children can be dissolved in a liquid (juice, milk, etc..), If a child swallows them hard.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Acceptance of Broncho-vaksom not recommended for children under 6 months of age because of the immaturity of their immune system.

Pregnancy and lactation

Studies on reproduction in animals show no danger to the fetus, but there are no data from controlled trials in pregnant women. As for breastfeeding, no specific studies have not been conducted so far and have not provided any data.

DRIVE AND CONTROL OF MACHINES

Broncho-vaksom not affect driving or operating machinery.

SIDE EFFECTS

The incidence of adverse effects in clinical trials is between 3-4%. Gastrointestinal complaints (nausea, abdominal pain, vomiting), skin reactions (rash, urticaria) and respiratory disorders (cough, dyspnea, asthma) and common problems (fever, fatigue, allergic reactions) are the most frequently reported complaints.

In case of prolonged gastrointestinal disorders, treatment should be prekasne.Pri lasting skin reactions and respiratory problems, treatment should be discontinued as can trigger an allergic reaction.

INTERACTIONS

In patients receiving immunosuppressive therapy or immune deficiency effect of Broncho-vaksom may be weaker.

OVERDOSE

Signs of overdose has been reported.

Physical and Chemical Incompatibilities

There are currently unknown.

SHELF LIFE

Stored in originalnati packages Broncho-vaksom has a shelf life of 5 years.

STORAGE CONDITIONS

The drug should be stored pa place protected from heat (15-25 ° C). Do not use after the expiration date printed on the package.