Capsules Ermital 25000ED, # 20

Dosage 10,000 IU: Solid oblong gelatin capsule size No. 2, brown opaque lid, colorless transparent body. Capsule contents: whitish-gray convex film-coated microtablets the presence of a characteristic odor in microtablets is allowed. Dosage 25,000 U: Hard, oblong gelatin capsule, size no. 0 el, brown opaque cap, colorless transparent body. Capsule contents: whitish-gray convex film-coated microtablets the presence of a characteristic odor in microtablets is allowed. Dosage 36,000 U: Hard, elongated gelatin capsule, size No. 00, brown opaque cap, colorless transparent body. Capsule contents: whitish-gray convex film-coated microtablets the presence of a characteristic odor in microtablets is allowed.

Pharmaco-therapeutic group

N4 In adults and children: to improve the digestion of food in patients with normal gastrointestinal tract function in case of nutritional deficiencies

replacement therapy for exocrine pancreatic insufficiency: cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, ductal obstruction due to neoplasm (including obstruction of the pancreatic ducts, common bile duct), Schwachman-Diamond syndrome, conditions after an attack and acute pancreatitis renewal of food

symptomatic therapy of digestive disorders: condition after cholecystectomy, partial gastrectomy (Billroth-I / II), total gastrectomy, duodeno- and gastrostasis, biliary obstruction, cholestatic hepatitis, liver cirrhosis, Crohn's disease, dysbiosis.

Application during pregnancy and during breastfeeding

The use of the drug Ermital® during pregnancy and lactation is possible only after a careful assessment of the ratio of benefits to the mother and risks to the fetus or baby.

Due to the insignificant systemic absorption of pancreatin, a negative effect on the mother's body, as well as the fetus and infant, is not expected.

Dosage form

Capsules 10,000 IU, 25,000 IU, 36,000 IU.

There are 20 or 50 capsules in a dark glass vial, sealed with a plastic cap, the vial is equipped with a sealing disc, consisting of two parts, fastened with wax points.

The first opening splits the disc into two parts.

Part 1 (glassine / aluminum foil / wax dots) remains on the neck of the bottle and part 2 (aluminum foil / paper / cardboard) remains in the cap.

1 bottle in a cardboard box together with instructions for medical use of the medicinal product.

Shelf life

3 years.

Do not use after the expiration date stated on the package. Use after the expiration date stated on the package.

Category

Gastrointestinal tract

Name ENG

ERMYTAL

Clinical and pharmacological group

Enzyme preparation

ATX code

Multienzymes (lipase, protease etc.)

Dosage

25000ED

Structure

Dosage 25,000 U: One capsule with gastric-resistant microtablets contains 218.2 - 282.4 mg of pancreatin from the pancreas of a pig, which corresponds to a lipase activity of 25,000 U, amylase

22,500 units, proteases 1 250 units (according to the European Pharmacopoeia).

.Auxiliary substances: microcrystalline cellulose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate

film coating of microtablets: copolymer of methacrylic acid and ethyl acrylate (1: 1), triethyl citrate, talc, simethicone

polishing agent: montan glycol wax. Capsule cap: gelatin, red iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate

capsule body: gelatin, sodium lauryl sulfate.

Indications

In adults and children: - to improve the digestion of food in patients with normal gastrointestinal tract function in case of inaccuracies in nutrition

- replacement therapy for exocrine pancreatic insufficiency: cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, ductal obstruction due to neoplasm (including obstruction of the pancreatic duct, common bile duct), Schwachman-Diamond syndrome, conditions after an attack and re-feeding

- symptomatic therapy of digestive disorders: condition after cholecystectomy, partial gastrectomy (Billroth-I / II), total gastrectomy, duodeno- and gastrostasis, biliary obstruction, cholestatic hepatitis, liver cirrhosis, Crohn's disease, dysbiosis.

Contraindications

Known hypersensitivity to any component of the drug.

INN / Active ingredient

Pancreatin

Storage conditions and periods

At a temperature not higher than 25? С.

Keep out of the reach of children!

Specifications

Category

Preparations for the gastrointestinal tract

,

Enzymes

Scope of the medicinal product

Gastrointestinal tract

Release form

Capsules

Manufacturer country

Germany

Package quantity, pcs

twenty

Scope of application

Gastroenterology

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Nordmark Arzneimittel GmbH

The amount of the dosage form in the primary package

20 pcs.

Primary packaging type

Dark glass bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Digestive Enzyme Remedy

Anatomical and therapeutic characteristics

A09AA02 Polyenzyme preparations (lipase + protease, etc.)

Dosage form

Capsules

Expiration date in days

1095

Package weight, g

75

Mode of application

:

Inside, the doses are selected individually, depending on the severity of the disease and diet. The dose is calculated in terms of units of lipase activity. Capsules should be swallowed whole during meals with plenty of fluids (water, juices) if it is difficult to swallow, the capsules can be opened and their contents added to liquid food that has a sour taste (pH5.5), or the contents of the capsules can be poured into the mouth and swallowed without chewing and drinking plenty of liquid (about a glass of water). Crushing, chewing microtablets or adding them to food with a pH of 5.5 leads to the destruction of their shell, which protects against the action of gastric juice. This can lead to early release of enzymes in the mouth, decreased effectiveness and irritation of the mucous membranes. Make sure there are no microtablets left in your mouth.Cystic fibrosis The dose depends on body weight and should be 1000 lipase units / kg at the beginning of treatment for each meal for children under four years of age and 500 lipase units / kg at meals for children over four years of age and adults. The dose should be determined depending on the severity of the symptoms of the disease, the results of steatorrhea control and the maintenance of an adequate nutritional status. In most patients, the dose should remain less than or not exceed 10,000 lipase units / kg of body weight per day or 4,000 lipase units / g of fat consumed. Other conditions accompanied by exocrine pancreatic insufficiency The recommended dose is 2-4 capsules of Ermital® 10,000 IU, or 1-2 capsules of Ermital® 25,000 IU, or 1 capsule of Ermital® 36,000 IU with each meal.The dose can be increased if necessary. Dose escalation should be under the supervision of a physician. Do not exceed the daily dose of enzymes in the range of 15-20 thousand lipase units per kg of body weight. Therapy should be carried out against a background of abundant fluid intake. In children, the drug should be used in accordance with the doctor's prescription.

Dosage (volume) of the substance in the preparation

:

microtablets contains 218.2 - 282.4 mg of pancreatin from the pancreas of a pig, which corresponds to the activity of lipase 25,000 units, amylase 22,500 units, proteases 1 250 units (according to the European Pharmacopoeia).

Information on technical characteristics, delivery set, country of manufacture