Active substancePancreatinPancreatin
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  • Dosage form: & nbspcapsules
    Composition:Composition per 1 capsule:

    Active substance:

    Pancreatin in the form of enteric-soluble pellets,

    10000ED

    25000ED

    containing pancreatin

    168 mg *

    420 mg *

    powder, which corresponds to the activity:

    125 mg

    312 mg

    proteases

    520 units

    1300 units

    amylase

    7500 units

    19,000 units

    lipase

    10000 units

    25,000 units

    * - in terms of nominal lipolytic activity.
    Auxiliary substances, which are part of the enteric coating of pellets:
    methacrylic acid and ethyl acrylate copolymer (1: 1) (as a 30% dispersion, further comprising polysorbate-80, sodium lauryl sulfate) 25.3 mg / 63.2 mg, triethyl citrate 5.1 mg / 12.6 mg, simethicone emulsion 30%, dry weight (32.6%) 0.1 mg / 0.3 mg including: dimethicone - 27.8%; silicon colloid precipitated - 1.3%; silicon colloidal weighted - 0.9%; methyl cellulose - 2.5%; acid, sorbic - 0.1%; water - 67.4%, talc - 12.6 mg / 31.6 mg.
    Capsule shell composition: body: gelatin - up to 100%, water - 13-16%
    Cover: gelatin - up to 100%, water - 13-16%, dye crimson (Ponso 4R) - 0.6666% / 0.7999%, dye quinoline yellow - 0.1000% / 0.3166%, dye patented blue - 0,0200% / 0,0053%, titanium dioxide - 1,2999% / 2,9674%.
    Description:

    Hard gelatin capsules No. 2 transparent body with a brown lid (for a dosage of 10,000 units) and No. 0e1 a transparent case with a dark orange lid (for a dosage of 25,000 units). Contents of capsules - pellets of cylindrical or spherical or irregular shape from light brown to brown, with a characteristic odor. Color heterogeneity is allowed.

    Pharmacotherapeutic group:Digestive enzyme agent
    ATX: & nbsp

    A.09.A.A   Enzyme preparations

    A.09.A.A.02   Pancreatin

    Pharmacodynamics:

    Mikrazim® - pancreatin pellets in capsules. The preparation contains natural enzymes from the pancreas of animals - protease, lipase and amylase, which provide digestion of proteins, fats and carbohydrates of food.

    After taking Mikrazyma, the capsule dissolves rapidly in the stomach, releasing the pancreatin pellets coated with the enteric coating. Due to the small size, pellets quickly and evenly mix with food and simultaneously with the food lump easily enter the duodenum and then into the small intestine,where pancreatic enzymes are released and begin to act actively, facilitating the rapid and complete digestion of proteins, fats and carbohydrates of food.

    Rapid mixing of pancreatin pellets with the contents of the stomach, their uniform distribution in it, simultaneous passage with chyme, and also the preservation of enzymes before their operation in the intestine (due to the presence of an enteric coating of pellets), provide higher digestive activity and maximum approach of the drug to the natural process digestion. The enzymatic activity of Mikrizima® is manifested as much as possible after 30 minutes after ingestion, which ensures the rapid onset of the effect.

    After interaction with substrates, the protease, lipase and amylase in the lower parts of the intestine lose their activity and are removed from the body together with the intestinal contents.

    Mikrazim® is not absorbed from the gastrointestinal tract and acts only in the lumen of the intestine.

    Indications:

    Substitution therapy with exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, condition after irradiation, dyspepsia, cystic fibrosis; flatulence, diarrhea of ​​non-infectious genesis.

    Violation of digestion (a condition after resection of the stomach and small intestine) to improve food digestion in patients with normal function of the gastrointestinal tract in the case of errors in the diet (eating fatty foods, large quantities of food, irregular meals) and for violations of the chewing function, sedentary lifestyle, long-term immobilization. Remkheld's syndrome (gastrocardial syndrome).

    Contraindications:

    Individual intolerance to pancreatin or individual components of the drug. Acute pancreatitis, exacerbation of chronic pancreatitis.

    Pregnancy and lactation:

    Data on the potential risks of use of pancreatin during pregnancy and lactation are not available, so the drug should be administered to pregnant and lactating women only if the expected effect of therapy exceeds potential risks.

    Dosing and Administration:

    The dose of the drug is selected individually, depending on the age, severity of symptoms and composition of the diet. The dose is selected with the help of registered medicines Mikrazim® 10000 ED and Mikrazim® 25000 ED.Capsules are taken orally, squeezed with a sufficient amount of non-alkaline liquid (water, fruit 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 children or the elderly), the capsule can be opened and taken directly into microgranules, mixed with liquid or liquid food (pH <5.0), not requiring chewing (apple puree, yogurt). Grinding or chewing pellets, as well as adding them to food with a pH above 5.5, leads to the destruction of their shell, which protects against the action of gastric juice. Any mixture of microgranules with food or liquid should be taken immediately after preparation.,

    The admissible dose for children under the age of 13 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).

    Replacement therapy for various types of exocrine pancreatic insufficiency.

    The dose is selected individually and depends on the degree of manifestation of exocrine insufficiency, individual eating habits and the patient's age.

    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 dietary therapy, 25,000 units of lipase are administered at each meal. If necessary and good tolerability dose increase to 30 000 - 35 000 units of lipase per dose. A further increase in the dose, in most cases, does not improve the results of treatment and requires a revision of the diagnosis, a decrease in the fat content in the diet, and / or an additional prescription of proton pump inhibitors.

    With a mildly expressed steatorrhea, not accompanied by diarrhea and a decrease in body weight, a dose of 10,000 units to 25,000 units of lipase is administered.

    Cystic fibrosis.

    The initial calculated dose for children under 4 years is 1,000 ED lipase per kilogram of body weight for each feeding, for children older than 4 years, 500 ED of lipase per kilogram of body weight at each meal. 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.

    Side effects:Allergic reactions to the drug components are possible. When using large doses of the drug are rarely observed: diarrhea, nausea, constipation, discomfort in the epigastric region. With prolonged use in high doses, it is possible to develop hyperuricosuria, hyperuricemia.
    Overdose:

    Symptoms: an increase in uric acid in the urine (hyperuricuria) and blood (hyperuricemia). Children have constipation.

    Treatment: withdrawal of the drug, symptomatic therapy.

    Interaction:

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

    Special instructions:

    Children and adults who have been receiving pancreatin therapy for a long time in significant doses should be observed by a specialist.

    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 (helminthic invasion, dysbiosis); failure of recommended treatment regimens; use of enzymes that have lost their activity.
    Effect on the ability to drive transp. cf. and fur:There is no separate data.
    Form release / dosage:

    Capsules 10000 units and 25000 units.

    Packaging:

    By 3 (for a dosage of 10,000 units) or 10 capsules in a contour mesh box made of a polyvinylchloride film or a polyvinyl chloride / polyvinylidene chloride film and an aluminum printed lacquer foil.

    For 20, 30, 40 or 50 capsules in cans of polymeric with screw caps.

    Each can, 1 capsule, 3 capsules, or 1, 2, 3, 4 or 5 contiguous cell packs of 10 capsules, together with instructions for use, is placed in a pack of cardboard.

    Storage conditions:

    In dry and protected from light and out of reach of children at a temperature not exceeding 25 ° C.

    Shelf life:2 years. The drug should not be used after the expiration date!
    Terms of leave from pharmacies:Without recipe
    Registration number:LS-000995
    Date of registration:18.10.2011 / 16.01.2018
    Expiration Date:Unlimited
    The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp08.06.2018
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