MIKRAZIM

Active material: Pancreatin
When ATH: A09AA02
CCF: The enzyme preparation
ICD-10 codes (testimony): C25, E84, K30, K80, K82.8, K83.1, K86.1, K86.8, K90.3, K91.2, K91.5, Z51.4
When CSF: 11.05
Manufacturer: STI-MED-SORB JSC (Russia)

Pharmaceutical form, composition and packaging

◊ Capsules hard gelatin, size №2, with a brown cap and a transparent casing; contents of capsules – pellets of cylindrical or Oblate spheroid shape from light brown to Brown, with a characteristic odor.

Excipients: Shell Microsphere: èudragit (E100) (methyl methacrylate, dimethylaminoethyl methacrylate and butyl methacrylate copolymer), triэtiltsitrat, talc, simethicone emulsion.

Ingredients of the capsule shell: gelatin, water, sodium lauryl, methylparaben, propyl, Dyes (poncho 4R, quinoline yellow, patent blue V, Titanium dioxide).

10 PC. – packings Valium planimetric (1) – packs cardboard.
10 PC. – packings Valium planimetric (2) – packs cardboard.
10 PC. – packings Valium planimetric (3) – packs cardboard.
10 PC. – packings Valium planimetric (4) – packs cardboard.
10 PC. – packings Valium planimetric (5) – packs cardboard.
20 PC. – plastic bottles (1) – packs cardboard.
30 PC. – plastic bottles (1) – packs cardboard.
40 PC. – plastic bottles (1) – packs cardboard.
50 PC. – plastic bottles (1) – packs cardboard.
20 PC. – jars of dark glass (1) – packs cardboard.
30 PC. – jars of dark glass (1) – packs cardboard.
40 PC. – jars of dark glass (1) – packs cardboard.
50 PC. – jars of dark glass (1) – packs cardboard.

◊ Capsules hard gelatin, size №0, with dark orange cover and transparent casing; contents of capsules – pellets of cylindrical or Oblate spheroid shape from light brown to Brown, with a characteristic odor.

Excipients: Shell Microsphere: èudragit (E100) (methyl methacrylate, dimethylaminoethyl methacrylate and butyl methacrylate copolymer), triэtiltsitrat, talc, simethicone emulsion.

Ingredients of the capsule shell: gelatin, water, sodium lauryl, metilparagidroksiʙenzoat, propilparagidroksibenzoat, Dyes (poncho 4R, quinoline yellow, patent blue V, Titanium dioxide).

10 PC. – packings Valium planimetric (1) – packs cardboard.
10 PC. – packings Valium planimetric (2) – packs cardboard.
10 PC. – packings Valium planimetric (3) – packs cardboard.
10 PC. – packings Valium planimetric (4) – packs cardboard.
10 PC. – packings Valium planimetric (5) – packs cardboard.
20 PC. – jars of dark glass (1) – packs cardboard.
20 PC. – plastic bottles (1) – packs cardboard.
30 PC. – jars of dark glass (1) – packs cardboard.
30 PC. – plastic bottles (1) – packs cardboard.
40 PC. – jars of dark glass (1) – packs cardboard.
40 PC. – plastic bottles (1) – packs cardboard.
50 PC. – jars of dark glass (1) – packs cardboard.
50 PC. – plastic bottles (1) – packs cardboard.

Pharmacological action

Enzyme preparation from the pancreas of animals, composed of protease, lipase and amylase, to ensure that digestion of proteins, fat and carbohydrate foods.

After taking the drug under jelatinova capsule action of gastric juice dissolves in the stomach and micro pancreatin, stable in the acidic stomach Wednesday, together with gastric contents fall into the duodenum, and then in small intestine, where does the release of digestive enzymes and digestion of food jenzimaticheskoe is provided. Pancreatin granules form ensures more rapid mixing of digestive enzymes from intestinal contents and their even distribution, What causes a higher perevarivajushhuju activity.

Pancreatin enzyme activity manifests itself as much as possible through the 30-40 minutes after ingestion.

Pharmacokinetics

After interaction with substrates protease, lipase and amylase in the lower intestine lose activity and, together with the intestinal content removed from the body.

The drug is not absorbed from the intestine and acts locally.

Testimony

Substitution therapy in external pancreatic insufficiency:

-chronic pancreatitis;

- Mukovystsydoz;

-tumors of the pancreas;

— surgical interventions on the pancreas.

Symptomatic therapy in complex treatment for the correction of the digestive process, occur in other diseases or pathological conditions of the GASTROINTESTINAL TRACT:

-conditions after gastrectomy, gallbladder, part of the bowel;

is a disease or condition, violating bile process (liver disease, cholecystitis, gall bladder stones, chronic diseases of biliary tract, impaction of the biliary tract Neoplasms, kistoznymi growths);

-bowel disease, violating the intestinal contents move.

To improve food digestion in adults and children with a normal function of the DIGESTIVE TRACT if:

— errors in diet (consumption of fatty foods or large amounts of food, irregular meals);

-violations of chewing function, When sedentary lifestyle, prolonged immobilization.

Preparation for x-ray and ultrasound examination of abdominal cavity organs.

Dosage regimen

Dose picked individually depending on the severity of the disease and diet. If a single dose of the drug more 1 capsules, should take half of the total number of capsules immediately before the meal, and the other half – while eating, with non-alkaline liquid (water, fruit juices). If a single dose is 1 capsule, It should take at meal times.

When swallowing difficulties and children can be opened and the capsule to add micro to food, that does not require chewing (eg, yablochnoe puree, yogurt). Grinding or chewing microgranules, as well as adding them to food with a pH above 5.5 leads to destruction of the shell, protecting them from the action of the gastric juice. Prepared mixture should be used immediately.

During the enzyme therapy to use enough liquid, liquid deficiency may cause constipation.

At mukovystsydoze initial estimated dose for children from 1 to 4 years is 1000 Lipase UNITS/kg of body weight at each feeding, to older children 4 years - 500 Lipase UNITS/kg of body weight at every meal. The dose should be selected individually, depending on the severity of the disease, severity of steatorrhea and nutritivnogo status. Supporting dose for most patients should not exceed 10 000 Lipase UNITS/kg body weight/day.

At other types of exocrine pancreatic insufficiency or substitution therapy in patients with chronic pancreatitis doses of enzymes depend on the degree of external failure, as well as individual dietary habits of the patient.

At steatoree (more 15 grams of fat in the stool per day), and if the diarrhoea and reduce body weight, When the diet has no significant effect, appoint 25 000 U lipases at every meal. If necessary, and good endurance dose increase to 30 000-35 000 UNITS of lipase on 1 reception. Further increase in dose, In most cases, improves treatment results and require revision of the diagnosis, reduce the fat content in the diet and/or supplemental drugs – proton pump inhibitors. At out of focus pronounced steatoree, not accompanied by diarrhea and reduced body weight, assign from 10 000 to 25 000 UNITS of lipase on reception.

Permissible dose for Children up to 1.5 years – 50 000 Lipase UNITS/day; to older children 1.5 years daily dose should not exceed – 100 000 U lipase.

Side effect

Maybe: allergic reactions.

Rarely: when used in high doses – diarrhea, nausea, constipation, discomfort in epigastric.

At long-term use at high doses: perhaps development giperurikozurii, hyperuricemia.

At Cystic Fibrosis in case of exceeding the necessary dose of pancreatin Perhaps the strictures (fibrous colonopathy) in the ileocekal'nom Division of the ascending part of the colon.

Contraindications

- Acute pancreatitis;

- Exacerbation of chronic pancreatitis;

- Hypersensitivity to the drug.

Pregnancy and lactation

Data on the use of Mikrazima^® Pregnancy and lactation (breast-feeding) no, Therefore, use of the drug is possible only in cases, when the intended benefits to the mother outweighs the potential risk to the fetus or child.

Cautions

Children and adults, for a long time, receiving pankreatinom therapy in the substantial doses, should be monitored regularly at specialist.

The main reasons for the ineffectiveness of enzyme therapy enzymes inactivation are in the duodenum as a result of acidification of its contents, concomitant diseases of the small intestine (helminthic infestation, dysbiosis), duodenostasis, the failure of patients to treatment regimens recommended, use of enzymes, no longer active.

Substitution therapy for pancreatic enzyme deficiency cannot replace treatment of the underlying disease.

Overdose

Symptoms: giperurikozurija, hyperuricemia; children – constipation.

Treatment: removal of the drug; if necessary, symptomatic therapy.

Drug Interactions

Together with the use of pancreatin with drugs iron may reduce iron intake.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored in a dry, protected from light and away from children at a temperature no higher than 25 ° C. Shelf life – 2 year.