Pancreatin tab. p / o intestinal. 25ED №60

Release form, composition and packaging

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Enteric-coated tablets 1 tab.

pancreatin 100 mg

with enzymatic activity:

lipase not less than 140 U

amylase not less than 1 500 U

protease 25 UNITS

60 pcs.

- dark glass jars (1) - cardboard packs.

10 pieces.

- blisters (6) - cardboard packs.

pharmachologic effect

Enzymatic agent.

Contains pancreatic enzymes - amylase, lipase and proteases, which facilitate the digestion of carbohydrates, fats and proteins, which contributes to their more complete absorption in the small intestine.

In diseases of the pancreas, it compensates for the insufficiency of its exocrine function and helps to improve the digestion process.

Pharmacokinetics

The pharmacokinetics of pancreatin have not been studied.

Indications for use

Lack of exocrine pancreatic function (including chronic pancreatitis, cystic fibrosis).

Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gallbladder

conditions after resection or irradiation of these organs, accompanied by impaired food digestion, flatulence, diarrhea (as part of combination therapy).

To improve the digestion of food in patients with normal gastrointestinal tract function in case of errors in nutrition, as well as in violation of chewing function, forced prolonged immobilization, a sedentary lifestyle.

Preparation for X-ray and ultrasound examination of the abdominal organs.

Contraindications for use

Acute pancreatitis.

Hypersensitivity to pancreatin.

Dosage regimen

The dose (in terms of lipase) depends on the age and the degree of pancreatic insufficiency.

The average dose for adults is 150,000 U / day.

With complete insufficiency of the exocrine function of the pancreas - 400,000 U / day, which corresponds to the daily requirement of an adult for lipase.

The maximum daily dose is 15,000 U / kg.

Children under the age of 1.5 years - 50,000 U / day

over 1.5 years old - 100,000 U / day.

The duration of treatment can vary from several days (if the digestive process is disturbed due to dietary errors) to several months or even years (if constant substitution therapy is necessary).

Side effect

When used in moderate therapeutic doses, side effects are observed in less than 1%.

From the digestive system: in some cases - diarrhea, constipation, a feeling of discomfort in the stomach, nausea.

The cause-and-effect relationship between the development of these reactions and the action of pancreatin has not been established.

these phenomena refer to the symptoms of exocrine pancreatic insufficiency.

Allergic reactions: in some cases - skin manifestations.

From the side of metabolism: with prolonged use in high doses, hyperuricosuria may develop, in excessively high doses - an increase in the level of uric acid in the blood plasma.

Others: when using pancreatin in high doses in children, perianal irritation may occur.

Drug interactions

With simultaneous use with antacids containing calcium carbonate and / or magnesium hydroxide, it is possible to reduce the effectiveness of pancreatin.

With simultaneous use, it is theoretically possible to reduce the clinical efficacy of acarbose.

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

Application during pregnancy and lactation

The safety of using pancreatin during pregnancy has not been studied enough.

Application is possible in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

In experimental studies, it was found that pancreatin does not have a teratogenic effect.

Special instructions It is not recommended to use in the acute phase of chronic pancreatitis.

In cystic fibrosis, the dose should be adequate to the amount of enzymes required for the absorption of fats, taking into account the quality

Name ENG

PANCREATIN

Clinical and pharmacological group

Enzyme preparation

ATX code

Multienzymes (lipase, protease etc.)

Dosage

25ED

Structure

Active substance: pancreatin 250 mg

Excipients: sodium carboxymethyl starch, pregelatinized starch, low molecular weight medical polyvinylpyrrolidone (povidone), magnesium stearate, microcrystalline cellulose

INN / Active ingredient

pancreatin

Storage conditions and periods

At a temperature not exceeding 25 degrees, in the original packaging.

Expiration date: 2 years

Specifications

Category

Preparations for the gastrointestinal tract

,

Enzymes

Scope of the drug

Gastrointestinal tract

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

60

Minimum age from

3 years old

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Avexim

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

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

Enteric-coated tablets

The target audience

Adult

Expiration date in days

730

Dosage (volume) of the substance in the preparation

250 mg

Package weight, g

thirty

Mode of application

:

Inside, swallowing whole (without chewing), during or immediately after meals, with plenty of liquid (alkaline if possible: water, fruit juices). The dose of the drug is set individually (in terms of lipase) depending on the age and degree of pancreatic insufficiency. < br> < br> It is not recommended to exceed the maximum daily dose of enzymes, which is 15,000-20,000 U of lipase / kg, especially in patients with cystic fibrosis. < br> < br> The average dose for adults is 150 thousand units / day with complete insufficiency of the exocrine function of the pancreas - 400 thousand units / day, which corresponds to the daily requirement of an adult for lipase. < br> < br> The duration of treatment can vary from a single dose or several days (if the digestive process is disturbed due to inaccuracies in the diet) to several months or even years (if constant replacement therapy is necessary). Adults - 3-4 tablets 3 times a day. Higher doses are prescribed by your doctor. 2 tablets 2-3 times a day for 2-3 days before X-ray or ultrasound examination. < br> < br> Children over 3 years old - 100 thousand units / day (by lipase), divided by 3-4 reception.Children over 3 years old - 100 thousand units / day (by lipase), divided into 3-4 doses.Children over 3 years old - 100 thousand units / day (by lipase), divided into 3-4 doses.

Information on technical characteristics, delivery set, country of manufacture