Enterozhermina® (12 capsules)

The instruction for medical use of ENTEROZhERMINA medicine the Trade name of Enterozhermina the International unlicensed name Is not present the Dosage form of the Structure One Capsule Capsule contains active agent - Bacillus clausii spores polyresistant to various chemotherapeutic drugs and antibiotics - 2 billion spores, excipients: heavy kaolin, cellulose microcrystalline, magnesium stearate, structure of a cover: gelatin, the titan dioxide (E171), the water purified. The description Solid gelatin capsules 1 of No. in size, with the opaque body of white color and an opaque lid of white color. Contents of capsules – small powder from whitish color to color of ivory. Pharmacotherapeutic group Digestive tract and metabolism. Antidiarrheal, intestinal anti-inflammatory/antimicrobial drugs. Anti-diarrheal microorganisms. The ATX A07FA code the Pharmacological Pharmacokinetics As properties active agent of the drug Enterozhermina are the spores of bacteria localized and operating only in a digestive tract gleam, pharmacokinetic researches were not conducted. The pharmacodynamics of Enterozhermina is the drug consisting of Bacillus clausii spores – the ordinary inhabitant of the intestines which do not have pathogenic effect. At oral administration Bacillus clausii spores, thanks to the high chemical and physical substances resistance, get through a barrier of gastric juice and in the intact state reach an intestinal path where they will be transformed to metabolic active vegetative cells. Thanks to action of Bacillus clausii the use of Enterozhermina medicine promotes restoration of the intestinal microflora broken as a result of influence of various factors. As Bacillus clausii is also capable to produce various vitamins, in particular vitamins of group B, Enterozhermina® contributes to normalization of disturbance of the vitamin balance in an organism caused by antibiotics and chemotherapy in general. Энтерожермина® allows to achieve the nonspecific antigenic and anti-toxic effect which is closely connected with metabolic action of Bacillus clausii. Besides, artificially caused heterogeneous resistance of high degree of Bacillus clausii to antibiotics provides a therapeutic basis for prevention of disturbances of intestinal microflora as a result of use of antibiotics, especially, of a broad spectrum of activity, or for recovery of balance of intestinal microflora. Due to this resistance to antibiotics, Enterozhermina can be applied in an interval between two doses of antibiotics. Drug has stability concerning penicillin (if not in a combination with inhibitors beta lactamelements), cephalosporins (partial stability in most cases), tetracyclines, macroleads, aminoglycosides (except for gentamycin and amikacin), chloramphenicol, a tiamfenikol, lincomycin, clindamycin, an isoniazid, Cycloserinum, novobiocin, rifampicin, Acidum nalidixicum and pipemidovy acid (intermediate stability) and metronidazole. Indications - treatment and prevention of disturbances of intestinal microflora and the subsequent endogenous disvitaminoz - auxiliary therapy for restoration of the intestinal microflora changed in the result of treatment with antibiotics or chemotherapy - acute or chronic gastrointestinal disorders at adults and children are more senior than 6 years connected with poisoning or with intestinal dysbacteriosis (dismikrobiozy) and disvitaminozy the Route of administration and doses to Children are more senior than 6 years: on 1 capsule 1 or 2 of time a day. Adult: on 1 capsule 2 or 3 of time a day. Duration of treatment is defined individually by the doctor. The following duration of treatment depending on indications is recommended: - treatment of disturbances of intestinal microflora and subsequent endogenous disvitaminoz: in acute diarrhea of 5-7 days, in chronic diarrhea up to 30 days, - prevention of disturbances of intestinal microflora and the subsequent endogenous disvitaminoz during antibacterial therapy: during treatment by antibiotics and up to 1 week after the end of treatment by antibiotics, - auxiliary treatment for restoration of the intestinal microflora which changed during treatment by antibiotics or chemotherapy: during treatment by antibiotics and up to 1 week after the end of treatment by antibiotics, - treatment of acute gastrointestinal disorders at adults and children is more senior than 6 years connected with poisoning or with intestinal dysbacteriosis (dismikrobiozy) and disvitaminozy: acute diarrhea of 5-7 days, - treatment of chronic gastrointestinal disorders at adults and children is more senior than 6 years connected with poisoning or with intestinal dysbacteriosis (dismikrobiozy) and disvitaminozy: chronic diarrhea up to 30 days. Route of administration: Capsules should be accepted entirely, washing down with a small amount of water or a small amount of liquid. Энтерожермина® capsules are not recommended to be used at babies and children up to 6 years (as they cannot swallow the capsule), Enterozhermina® oral suspension is suitable for this group of patients. Side effects Frequency is unknown - (including rash, urticaria and a Quincke's disease) it is important to reaction of hypersensitivity to report the Message about the suspected side reactions about the suspected side reactions during the post-registration period of use of medicine. It allows to conduct continuous monitoring of a ratio advantage/risk of drug. Experts in the field of health care are obliged to report about any cases of the suspected side reactions through national reporting system. Contraindications - hypersensitivity to components or any of drug ingredients Medicinal interactions Medicinal interactions as a result of a concomitant use with other medicines are not known. Special instructions during therapy by antibiotics the drug should be taken between two consecutive receptions of a dose of an antibiotic. Patients have to see the attending physician at deterioration in a clinical state after 2-3 days of treatment, and have to consult immediately with the doctor at emergence of the following symptoms: heat, vomiting, blood or slime in Calais, strong thirst, dryness in a mouth and also in the absence of improvement of a state after two days of treatment. Pregnancy and the period of a lactation Intake of this medicine is possible during pregnancy and in the period of a lactation. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Drug does not affect the abilities necessary for driving and the machine equipment. Overdose Currently clinical manifestations of overdose are not registered. A form of release and packing On 12 capsules in blister strip packaging from polyvinylchloride / polivinildenkhlorida / aluminum. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store storage conditions at a temperature not above 30os. To store out of children's reach! 3 years not to apply a period of storage after an expiration date. Prescription status Without prescription the Producer/owner of the registration certificate of Sanofi S.P.A., Italy Viale Europa, 11 - 221040 Origgio (VA), Italy the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Nazarbayev Ave 187 of B phone number: +7 (727) 244-50-96 fax: +7 (727) 258-25-96 e-mail: quality.info@sanofi.com the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Nazarbayev Ave of 187 B phone number: +7 (727) 244-50-96 fax: +7 (727) 258-25-96 e-mail: Kazakhstan.Pharmacovigilance@sanofi.com