Active substancePancreatinPancreatin
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  • Dosage form: & nbspcapsules
    Composition:

    Composition per 1 capsule:

    The active substance-

    pancreatin - in the form of

    intestine-soluble pellets (microgranules) - 672.0 mg of pancreatin-containing powder - 512.0 mg

    which corresponds to the activity:

    protease - 2080 units

    amylase - 30240 units

    lipase - 40000 units

    Auxiliary substances in the intestine-soluble shell of pellets (microgranules): methacrylic acid and ethyl acrylate copolymer [1: 1] - 93.91 mg, triethyl citrate -18.75 mg, simethicone emulsion 0.47 mg, talc 46.95 mg .

    The composition of the capsule shell: Body: gelatin - 85.5%, water - 14.5 %.

    Cap: gelatin - 83.15%, water - 14.5%, dye sunset yellow - 0.55%, titanium dioxide - 1.7998 %.

    Description:

    Hard gelatin capsules № 00 with a transparent casing and an orange lid. The contents of the capsules are pellets (micro granules) of cylindrical or spherical shape from light brown to brown, with a characteristic odor.

    Pharmacotherapeutic group:Digestive enzyme agent
    ATX: & nbsp

    A.09.A.A   Enzyme preparations

    A.09.A.A.02   Pancreatin

    Pharmacodynamics:

    Micrazim® - microgranulated pancreatin in capsules. The preparation includes enzymes - protease, lipase and amylase, which provide digestion of proteins, fats and carbohydrates of food. After taking the drug, Mikrazim®, the gelatin capsule dissolves in the stomach for 1-2 minutes, releasing microgranules pancreatin, covered with an enteric membrane. In the stomach, microgranules quickly and evenly mix with food and, thanks to their small size, easily prpannikayut in the duodenum simultaneously with the food lump. This ensures the reproduction of the natural digestion process, and the maximum speed of the onset of the effect.

    The acid-fast coating of microgranules allows to keep the enzymes completely intact before they start working in the intestines, which ensures their maximum digestive activity.

    In the small intestine at pH> 5.5, the membrane of the microgranules dissolves and at least 97% is released from the microgranules within 30 minutes. enzymes.

    Pharmacokinetics:

    Pharmacological activity of drugs containing pancreatic enzymes, including the drug "Mikrazim®, is realized in the lumen of the gastrointestinal tract, absorption is not required for the manifestation of their effects.

    The intestinal bioavailability of the drug reaches 100%.

    Indications:

    Substitution therapy for violations of exocrine pancreatic function associated with:

    - hereditary diseases - cystic fibrosis;

    - chronic pancreatitis due to intoxication or illness;

    - operative intervention on the pancreas, pancreatectomy;

    - violation of patency and compression of the ducts of the pancreas (tumors of the pancreas, liver, other organs);

    - a decrease in the enzyme-forming function of the gastrointestinal tract in elderly patients. Substitution therapy with exocrine pancreatic insufficiency can not replace the treatment of the underlying disease.

    For symptomatic therapy violations of digestive processes in the following cases:

    - state after resection of the stomach, removal of the gallbladder, part of the intestine,

    - diseases and conditions, accompanied by a violation of the process of biliary excretion (liver disease, cholecystitis, gallstones,chronic diseases of the biliary tract, compression (obstruction) of the bile ducts by neoplasms, cystic growths, etc.);

    For use in integrated training to X-ray examination and ultrasound of the abdominal cavity organs.

    Contraindications:

    Acute pancreatitis (in the early stages), exacerbation of chronic pancreatitis, individual intolerance to pancreatin or individual components of the drug.

    Pregnancy and lactation:

    The use of mikrazyme in pregnancy and lactation (breastfeeding) is recommended if the expected positive effect of therapy for the mother exceeds the possible risk for the fetus or child, due to the lack of reliable clinical data confirming the safety of pancreatic enzyme use this category of patients.

    Dosing and Administration:

    Mikrazim® can be administered to patients of all ages, including infants and elderly people, thanks to the possibility of individual dose selection by combining drugs with different dosages, and also because of the possibility of using directly the contents of gelatin capsules (microgranules).

    Capsules are taken orally, during or after a meal, without chewing, squeezed with enough liquid (water, juices). If a single dose of the drug is more than 1 capsule, you should take half of the total number of capsules immediately before eating, and the other half - while eating. If a single dose is 1 capsule, it should be taken with meals.

    If swallowing is difficult (for example, in young children or elderly people), the capsule is opened and taken directly in microgranules, mixed with a slightly acidic (pH <5.0) liquid or liquid in consistency with food that does not require chewing (pH <5,0 ). Any mixture of microgranules with food or liquid should be taken immediately after preparation.

    When treating Mikrazim® to prevent constipation, it is important to ensure a normal level of water intake, especially with increased loss of fluid.

    The dose of the drug is selected individually depending on the age and severity of the symptoms. To achieve adekvatnoy individual dose, except for capsules Mikrazim® 40000ED, It is possible to use the drug Mikrazim® with a dosage of 10000 units or 25000ED.

    Cystic fibrosis.

    For children older than 4 years, the average dose is 500 units lipases on kiThe body weight at each meal. For children under 4 years of age, the initial calculated dose of 1000 units of ED lipase per kilogram of body weight for each feeding (it is recommended to use the drug Mikrazim® 10000 U or 25,000 units)

    The dose should be selected individually, depending on the severity of the disease, the severity of steatorrhea and nutritional status. The maintenance dose for most patients should not exceed 10,000 units of lipase per kilogram of body weight per day.,

    In other conditions, accompanied by exocrine pancreatic insufficiency, the dose is set individually, taking into account the degree of insufficiency of digestion and the content of fats in food, individual eating habits and the age of the patient: The dose of lipase required by the patient during the main meal (breakfast, lunch or dinner) varies from 20,000 units to 75,000 units,

    When treated with Mikrazim®, the average initial dose of lipase is 10,000-25,000 units at the time of the main meal (with the use of Mikrazim 10000 ED or Mikrazim 25,000 units), but higher doses may be required to achieve a therapeutic effect. Usually the patient should receive, together with food, at least 20,000 ED-50,000 units of lipase

    With severe steatorrhea (more than 15 grams of fat in the feces per day), in the presence of diarrhea, a decrease in body weight and no effect of diet therapy, treatment starts with a dosage of 25,000 units of lipase at each meal, but if necessary and good tolerability, the dose is increased to 35,000 units -40000 units of lipase per dose. Further increasedose in most cases does not improve the results of treatment and requires a revision of the diagnosisbehind, reduction of fat in the diet and / or additional prescription of drugs - proton pump inhibitors.

    The average dose of pancreatin for adults is 150000 U / day; with a complete blockade of the exocrine function of the pancreas - 400,000 units / day, which corresponds to the daily needs of an adult in lipase. The maximum daily dose is 15,000 ED-20000 units / kg. The admissible dose for children under the age of 1.5 years is 50000 U / day; over 1,5 years - 100,000 units / day. The duration of pancreatin can vary from several days (digestive disorders) to several months or years (prolonged replacement therapy).

    Side effects:

    Rarely observed: allergic reactions, diarrhea, nausea, constipation, discomfort in the epigastric region.

    Overdose:

    There may be an increase in uric acid in the urine (hyperuricuria) and blood (hyperuricemia), in children - constipation.

    Treatment: withdrawal of the drug, symptomatic therapy, rehydration.

    Interaction:

    With the simultaneous use of pancreatin with iron preparations, it is possible to reduce absorption of the latter.

    Special instructions:

    The main reasons for the ineffectiveness of enzyme therapy are: inactivation of enzymes in the duodenum as a result of acidification of its contents; concomitant diseases of the small intestine invasion, dysbiosis); failure of recommended treatment regimens; use of enzymes that have lost their activity.

    In connection with the availability of data on the possible interrelation between the intake of highly active pancreatin preparations and the development of strictures in the ileocecal and ascending colon, careful monitoring of the gastrointestinal tract is necessary as a precaution in patients with cystic fibrosis, especially when using a dose of pancreatin more than 10,000 units of lipase / kg / day. Patients receiving long-term therapy with pancreatin in significant doses should be observed in a specialist - gastroenterologist.

    Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive cars and to control machines and mechanisms.
    Form release / dosage:

    Capsules 40000 units.

    Packaging:

    By 3, 5, 10 capsules in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    By 3, 5, 10 capsules in a contour mesh box made of aluminum foil of multi-layer and aluminum foil printed lacquered.

    For 20, 30, 40 or 50 capsules in plastic bottles.

    For 1 bottle or 1, 2, 3, 4, 6, 8 or 10 contour squares, together with the instructions for use, put in a pack of cardboard.

    Storage conditions:

    In a place protected from moisture and light at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001533
    Date of registration:24.02.2012
    The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp17.08.2015
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