Treatment of exocrine pancreatic insufficiency in adults and children caused by various diseases, including those listed below, but not limited to this list: chronic pancreatitis pancreatectomy; gastrectomy; surgery with imposing gastrointestinal anastomosis (eg resection of stomach by Billroth II); Schwachman-diamond syndrome; condition after an attack of acute pancreatitis and recovery of enteral or oral nutrition.
Ermital (pancreatin) Storage
active substance: pancreatin;
1 capsule 10000 IU contains pancreatin from the pancreas of pigs with enzymatic activity of lipase 10000 IU, amylase 9000 IU, protease 500 IU;
1 capsule 25000 IU contains pancreatin from the pancreas of pigs with enzymatic activity of lipase 25000 IU, amylase 22500 IU, protease 1250 IU;
1 capsule 36000 IU contains pancreatin from the pancreas of pigs with enzymatic activity of lipase 36000 IU, amylase 18000 IU, protease 1200 IU;
Excipients: microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate, methacrylate copolymer dispersion, triethyl citrate, talc, simethicone, montan-glycol wax, gelatin, iron oxide red (E 172), for dioxide (E 171), sodium lauryl sulfate.
Ermital (pancreatin) Dosage form
Capsules are gastroresistant firm.
Basic physical and chemical properties:
HERMITAL 10 000: oblong hard gelatin capsule size 2, lid brown, opaque, body colorless, transparent; capsule contents: whitish-gray round biconvex microplate tablets, film-coated, with a characteristic odor;
HERMITAL 25 000: oblong hard gelatin capsule size 0, lid brown, opaque, body colorless, transparent; capsule contents: whitish-gray round biconvex microplate tablets, film-coated, with a characteristic odor;
HERMITAL 36 000: oblong hard gelatin capsule size 00, lid brown, opaque, body colorless, transparent; capsule contents: whitish-gray round biconvex microtablets, film-coated, with a characteristic odor.
Drugs that improve digestion, including enzymes. Polyenzyme preparations. ATX code A09A A02.
The drug contains pancreatin from the pancreas of pigs in the form of enteric-coated (acid-resistant) microtablets in gelatin capsules. The capsules dissolve rapidly in the stomach, releasing micro-tablets on a multidose basis, which ensures good mixing with the stomach contents, transport from the stomach together with its contents and after release sufficient distribution of enzymes within the intestinal contents. When microtablets enter the small intestine, the shell dissolves rapidly (at pH> 5.5), releasing enzymes with lipolytic, amylolytic and proteolytic activity, which provides the breakdown of fats, carbohydrates and proteins. The products of pancreatic digestion are then absorbed either immediately or after further hydrolysis by intestinal enzymes.
Ermital (pancreatin) Pharmacokinetics.
Animal studies have shown no evidence of uptake of enzymes unchanged, and therefore classical pharmacokinetic studies have not been performed. Pancreatic enzyme supplements do not require absorption to achieve their effect. On the contrary, their full therapeutic effect is manifested in the lumen of the gastrointestinal tract. Moreover, as proteins, they undergo proteolytic digestion by passing through the gastrointestinal tract before being absorbed as peptides and amino acids.
Preclinical data do not indicate an appropriate acute, subchronic or chronic toxicity. No studies on genotoxicity, carcinogenicity or toxicity to reproduction have been performed.
Treatment of exocrine insufficiency of the pancreas in adults and children, which is caused by various diseases, including the following, but not limited to this list:
operations with the imposition of a gastrointestinal anastomosis (eg gastroenterostomy by Billroth II);
condition after an attack of acute pancreatitis and restoration of enteral or oral nutrition.
Hypersensitivity to the active substance of pancreatin, pig / pork proteins or to any other component of the drug.