International nonproprietary name:lyophylisate of bacterial lysates.
Key properties of the dosage form:
Broncho-VaxomAdults: the opaque hard gelatin capsules No. 3 with case and cover blue color, filled with powder of light beige colour
Broncho-VaxomChildren: the opaque hard gelatin capsules No. 3 with white housing and cap blue color, filled with powder of light beige color.
take 1 capsule, Broncho-VaxomAdultscontains
active ingredients:standardized lyophilisate OM-85 containing 7 mg of lyophilized bacterial lysates:Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Moraxella catarrhalis.
take 1 capsule, Broncho-VaxomChildrencontains
active ingredients:standardized lyophilisate OM-85 containing 3.5 mg of lyophilized bacterial lysates:Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Moraxella catarrhalis.
Excipients:propylgalate anhydrous (E 310), sodium glutamate (corresponding to sodium glutamate anhydrous), manit (E 421), corn starch modified, magnesium stearatecapsule shell constituents:indigotine (E 132), titanium dioxide (E 171) , gelatin.The
ATC CODER07A X. Means acting on the respiratory system.
Broncho-Vaxom stimulates the body's immune defense.
in the application of Broncho-VAX in humans, there is an increase in the level of circulating t lymphocytes, the content of IgA in saliva, a non-specific reaction to polyclonal mitogens and a mixed lymphocytic reaction.
Immunotherapy. Prevention of recurrent respiratory infections and severe infectious exacerbations of chronic bronchitis. A concomitant agent in the treatment of acute respiratory infections.
Adults and adolescents over 12
Preventive therapy/combination therapy:1 capsule per day on an empty stomach for 10 consecutive days per month, 3 consecutive months.
treatment of exacerbations:1 capsule per day on an empty stomach until symptoms disappear (minimum course - 10 days). In the case of concomitant administration with antibiotics, broncho-Wax is recommended to apply from the beginning of treatment.
Pediatric population(children aged 6 months to 12 years):the course of therapy does not differ from that for adults. Broncho-VaxomChildrencontains a dose (3.5 mg), half that of an adult.
note:Broncho-VAX capsulesChildrencan be opened. If the child is difficult to swallow the capsule, its contents can be mixed in the appropriate drinks (water, fruit juice, milk).
Side effects reported that are classified below in accordance with МеdDRA by organ system and frequency: very often (?1/10), often (?1/100 to<1/10), infrequently (?1/1,000 to<1/100), rare (?1/10,000 to <1/1000), very rare (<1/10000), including isolated cases, frequency unknown (cannot be evaluated according to the available data).
from the immune system:infrequently - hypersensitivity reactions (erythematous rashes, generalized rash, erythema, edema, eyelid edema, facial edema, peripheral edema, swelling, swelling of the face, itching, generalized itching, shortness of breath).
From the nervous system:is often a headache.
from the respiratory system, chest and mediastinal organs:frequent cough.
from the gastrointestinal tract:frequent-diarrhea, abdominal pain infrequently - nausea, vomiting.
in the skin and subcutaneous tissue:often - rash, rarely urticaria frequency unknown - angioedema.
General disorders and the condition of the injection site:infrequently - increased fatigue; rarely - fever.
In the case of long-term gastro-intestinal or respiratory disorders, the treatment should be stopped. In skin reactions treatment is also interrupted, as these manifestations may be allergic nature.
Hypersensitivity to the active substance or to any auxiliary substance forming part of Broncho-VAX.
the Drug Broncho-VAX children up to 6 months is not prescribed. The safety and efficacy of the drug in children under the age of 6 months have not been established.
Broncho-Vaxom can cause hypersensitivity reactions. In the case of allergic reactions or signs of intolerance to the drug treatment should be stopped immediately.
the Effect on the ability to drive and use machinery.
Broncho-VAX does not affect the ability to control the car and use the mechanisms.
Pregnancy and breast-feeding.
there are no Clinical data on the use of the drug for pregnant women. Animal experiments showed no direct or indirect toxicity, effect on pregnancy, embryo development, fetal growth and postnatal development. No specific studies have been carried out on breastfeeding and no data are available. The drug should be used with caution during pregnancy and breast-feeding.
Interaction with other drugs is currently unknown. TheOverdose.cases of overdose have not been reported to date. The biological nature of Broncho-VAX and the results of Toxicological studies carried out on animals indicate the impossibility of achieving overdose.
Store at temperatures between 15 ° C and 25 ° C, out of reach of children.The
10 capsules in a blister. 1 or 3 blisters in a cardboard carton together with instructions for use.The
According to the recipe.The
OM Pharma SA
St. Bois du LAN 1217 Meyrin 22, 2, Geneva, Switzerland.
in the case OF side effects (complications) after use of iibp, an emergency message should be sent to:
Department of medicines and medical products of the Ministry of health of Ukraine (01021, g.. Kiev, 7 Grushevskogo str., tel. (044) 200-07-93)
State enterprise "State expert centre of the Ministry of health of Ukraine" (03151, g. . Kiev, Ushinskogo str., 40, tel. (044) 393-75-86) and to the address of the manufacturer.
"Broncho-VAX" is an immunostimulatory agent in the form of a light beige powder in gelatin opaque capsules of bacterial origin.
the immune response of the digestive tract is observed during consumption, the number of circulating b-lymphocytes increases, which stimulates the production of antibody – protective line against infectious bacteria. The drug contributes to a strong stimulating effect on white blood cells. Thus, "Broncho-Vaxom" causes biological reactio