The instruction for medical use of Bronkho-Munal® medicine P Trade name of Bronkho-Munal® P International unlicensed name Is not present Medicinal a formakapsula of 3.5 mg Structure One capsule contains active agent - the lysate of bacteria of OM 85 lyophilized 20.00 mg corresponding: - to the lyophilized lysate of bacteria of 3.50 mg: Haemophilus influenzae Streptococcus (Diplococcus) of pneumoniae Klebsiella pneumoniae and ozaenae Staphylococcus aureus Streptococcus pyogenes and viridans Moraxella (Branhamella/Neisseria) catarrhalis - propyl gallate of anhydrous 0.042 mg - sodium a glutamate of anhydrous 1.515 mg - Mannitolum up to 20:00 mg excipients: Mannitolum, starch prezhelatinizirovanny, magnesium stearate. structure of a cover of the capsule: titan dioxide (E 171), gelatin. The description Solid gelatin capsules 3 of No. in size, with the body and a lid of white color. Contents of capsules - thinly granulated powder from white till slightly beige color. Pharmacotherapeutic group Immunomodulators. Immunostimulators. Other immunostimulators. The ATX L03AX code the Pharmacological Pharmacokinetics Later properties of intake drug is not soaked up in the standard way. After reception of the capsule, the lysate of bacteria collects in Peyerovy plaques of a mucous membrane of a GIT. Cavities of Peyerovy plaques absorb antigen and direct it to subepithelial lymphatic cells and by that the humoral immune response is caused that leads to more intensive products of IGA mucous which then get through a membrane of a mucous membrane and prevent penetration of microorganisms. Through Peyerovy plaques this antigen also stimulates lymphatic cells which then by means of regional lymph nodes migrate in a chest lymphatic channel, and then in a blood flow, and from there in a mucous membrane of a GIT and a respiratory path and other mucous membranes in which they have protective function. Thus, at the patients taking the drug the protection against bacteria and viruses increases. A pharmacodynamics of Bronkho-Munal® P contain the lyophilized lysate of bacteria most of which often cause respiratory infections: Streptococcus (Diplococcus) pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Moraxella (Branhamella/Neisseria) catarrhalis. Бронхо-Мунал® P modulates the immune response of an organism in fight against respiratory infections. Drug reduces the incidence frequency, duration and disease severity, promoting, thus, decrease in doses of antibiotics and other drugs. Drug stimulates cellular (locally in mucous airways), antibody-mediated (system) immunity, and nonspecific resistance. The following action of Bronkho-Munala® P is installed on protective mechanisms: • stimulation of alveolar macrophages, activation of emission of anti-inflammatory cytokines. • increase in number of the circulating T lymphocytes • activation of peripheral monocytes • increase in concentration secretory IgA on mucous membranes of airways and a digestive tract • stimulation of products of protective adhesive molecules • decrease in concentration of antibodies of the class IgE in the circulating blood - triggers of reactions of hypersensitivity. Indications - combined use with other drugs at treatment of respiratory infections - as prophylactic in recurrent infections of upper and lower airways (chronic bronchitis, tonsillitis, pharyngitis, laryngitis, rhinitis, sinusitis, otitis). The route of administration and doses of Bronkho-Munal® P is intended for intake, to accept in the morning on an empty stomach. If the patient forgot to accept Bronkho-Munal® P, it should be accepted the next morning. Children from 6 months to 12 years. For prevention of infectious diseases of airways appoint on 1 Bronkho-Munal® capsule P a day continuously, 10 day courses within 3 months. At an opportunity the treatment is begun in the same day of each of 3 next months, providing, thus, preservation of a 20-day break between individual courses. In a sharp phase of an infectious disease of airways it is necessary to accept on 1 Bronkho-Munal® capsule P a day continuously within 10 - 30 days. In the next two months it is necessary to accept on 1 capsule a day continuously within 10 days of every month. Between courses the 20-day interval has to remain. In need of purpose of an antibiotic of Bronkho-Munal® P it is necessary to accept as the accompanying means along with an antibiotic. For small children who cannot swallow the whole capsule it is recommended to open the capsule, then to mix capsule contents with drink (water, tea, milk or juice) and to accept ready mix inside in the morning on an empty stomach. Children from 12 to 18 years. For prevention of infectious diseases of airways appoint 2 Bronkho-Munal® capsules P a day continuously, 10 day courses within 3 months. At an opportunity the treatment is begun in the same day of each of 3 next months, providing, thus, preservation of a 20-day break between individual courses. In a sharp phase of an infectious disease of airways it is necessary to accept 2 Bronkho-Munal® capsules P a day continuously within 10 - 30 days. In the next two months it is necessary to accept 2 capsules a day continuously within 10 days of every month. Between courses the 20-day interval has to remain. In need of purpose of an antibiotic of Bronkho-Munal® P it is necessary to accept as the accompanying means along with an antibiotic. Side effects Often - diarrhea - a headache - an erythema Infrequently - an abdominal cavity pains, nausea, vomiting - feeling of weakness - a small tortoiseshell - a dieback - short wind, cough, asthma Seldom - fever, a fever - allergic reactions Very seldom - thrombocytopenia In isolated cases - the purpura connected or not connected with thrombocytopenia - dispnoe with rash - spasms in a stomach - a complication of an allergic vasculitis - idiopathic thrombocytopenia - a Quincke's edema, a Quincke's disease - a generalized dieback - a heavy arthralgia - a complication Cherdzha-Strauss's syndrome - tachycardia - feeling of weakness as a part of a syndrome of hypersensitivity - a Lyell's disease - a toxic epidermal necrolysis of the Contraindication - hypersensitivity to any of drug components - children's age up to 6 months - pregnancy and the period of a lactation Medicinal interactions are not established Special instructions It is recommended to observe a 4 weeks break between intake of live vaccine and use of Bronkho-Munal® of the Item. Pregnancy and a lactation Safety of its use at pregnancy and a lactation is not studied. At use in the period of a lactation it is necessary to stop breastfeeding. The feature of influence on ability to run transport and potentially dangerous Bronkho-Munal® mechanisms P does not influence ability to drive the car and mechanisms. The overdose is not revealed the Form of release and packing On 10 capsules in blister strip packaging from a film of polyvinylchloride/polyvinylidene chloride and aluminum foil. On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions in the dry place at a temperature not above 25 °C. To store out of children's reach! Not to use a period of storage of 5 years after the expiry date specified on packing. Prescription status Without prescription OHM Producer of Pharm, Switzerland 22, rue du Bois-du-Lan, 1217 Meyrin 2, Geneva the Packer/owner of the registration certificate Lek Pharmasyyutikals of of, Slovenia Verovskova 57, Ljubljana the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of JSC Sandoz Pharmasyyutikals d. d. in the Republic of Kazakhstan, Almaty, st. Luhansk 96, Phone number: +7 727 258 10 48, fax: +7 727 258 10 47 e-mail: kzsdz.drugsafety@sandoz.com 8 800 080 0066 – free number of dialing across Kazakhstan
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