Broncho - VAXOM . 7 mg. 30 capsules 

 

INGREDIENTS:

Broncho-vaksom is immunotherapy and preventive product. One capsule contains children, active substance: 

lyophilisate standardized bacterial lysates 20 mg ** of which 17.5 mg excipients and 3,5 mg bacterial lysates of the following types: 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 stearate - 3,000 mg

Propyl gallate - 0,042 mg

-1,515 Mg sodium glutamate 

Mannitol - up to 200,000 mg Capsule (average weight 50,00 mg):

Indigotine - 0,01 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

1 capsule for adults include:

Active substance:

lyophilisate standardized bacterial lysates 40 mg ** of which 17.5 mg excipients and 7 mg bacterial lysates of the following types: 

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 pyogene 

Streptococcus viridans (3 strains)

Branhamella catarrhalis (3 strains) 

Excipients

 

Modified corn starch 

(Pregelatinized) - 110,000 mg

Magnesium stearate - 3,000 mg

Propyl gallate - 0,084 mg

Glutamate - 3,030 mg 

Mannitol - up to 200,000 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 mg-3 

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 secretory. immunoglobulins in the mucosa of the respiratory tract,

Preclinical Safety Data: Toxicological studies show no toxic effects.

 

INDICATIONS

 

Immunotherapy. Prevention of recurrent respiratory infections and 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: 1 capsule daily on an empty stomach, until symptoms but at least 10 consecutive days. When necessary and antibiotic therapy, treatment started simultaneously with Broncho-vaksom. In children aged 6 months to 12 years: same regimen, but the dose is half (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

 

Stuies 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

 

Store in original packaging Broncho-vaksom has a shelf life of 5 years.

 

STORAGE CONDITIONS

 

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

PACKAGING

 

Broncho-vaksom for adults:

Boxes 10 and 30 capsules - 3 blisters of 10 hard capsules or 1 blister of 10 hard capsules.

Broncho-vaksom children: Boxes 10 and 30 capsules - 3 blisters of 10 capsules or hard I blister of 10 hard capsules.