Panzinorm forte 20,000 tab. p / o ksh / sol. # 30

Release form, composition and packaging

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Enteric-coated tablets of white or light gray color, smooth, round, biconvex, with the smell of vanillin and bergamot.

1 tab.

pancreatin with minimal enzymatic activity:

lipase 20,000 U Ph.Eur.

amylase 12,000 U Ph.Eur.

proteases 900 U Ph.Eur.

lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate.

Shell composition: hypromellose, copolymer of methacrylic acid and ethyl acrylate, triethyl citrate, titanium dioxide (E171), talc, simethicone emulsion, vanilla flavor 54286C, bergamot flavor 54253T, macrogol 6000, sodium carmellose, polysorbate 80.10 pcs.

- blisters (1) - cardboard packs.

10 pieces.

- blisters (3) - cardboard packs.

10 pieces.

- blisters (10) - cardboard packs.

10 pieces.

- bottles of dark glass (1) - packs of cardboard.

30 pcs.

- dark glass bottles (1) - cardboard packs.

100 pieces.

- dark glass bottles (1) - 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.

At the same time

Name ENG

PANZINORM FORTE 20,000

Clinical and pharmacological group

Enzyme preparation

ATX code

Multienzymes (lipase, protease etc.)

Dosage

269.12-279.44mg

Structure

1 tablet contains: NUCLEUS: Active substance: pancreatin (porcine) (with enzyme activity: lipase 20,000 Eur.Pharm., Amylase 12,000 U. Eur.Pharm. And drotease 900 U. Eur.Pharm.) 269.12 mg - 279.44 mg (15% excess of pancreatin is due to technical losses during the production process. 10% excess of pancreatin is used to compensate for losses during decay during the storage period.).

Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, anhydrous, magnesium stearate.

SHELL: hypromellose, methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide (E171), talc, simethicone emulsion, vanilla flavor 54286 C, bergamot flavor 54253 T, macrogol 6000, sodium carmellose, polysorbate 80.

Indications

insufficiency 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 digestion of food, flatulence, diarrhea (as part of combination therapy)

to improve the digestion of food in patients with normal gastrointestinal tract function in case of inaccuracies in nutrition, in violation of chewing function (damage to teeth and gums, during the period of getting used to dentures), a sedentary lifestyle, prolonged immobilization

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

INN / Active ingredient

pancreatin with minimal enzymatic activity:

Contraindications

acute pancreatitis

exacerbation of chronic pancreatitis

children under 3 years of age (for this dosage form)

children with cystic fibrosis under the age of 15

hypersensitivity to pork protein or other components of the drug.

The drug should be prescribed with caution during pregnancy.

Storage conditions and periods

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

Expiration date: 3 years

Specifications

Category

Preparations for the gastrointestinal tract

Scope of the drug

Gastrointestinal tract

Release form

Tablet

Manufacturer country

Slovenia

Package quantity, pcs

thirty

Scope of application

Gastroenterology

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

KRKA

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

1095

Package weight, g

thirty

Mode of application

:

Inside, take with meals. The tablets should be taken without chewing with sufficient liquid. < br> The dose and duration of therapy is determined individually, depending on the age and degree of pancreatic insufficiency. < br> Adults Panzinorm forte 20,000 is recommended to take (unless otherwise prescribed) at the beginning of treatment, 1 tablet 3 times a day, during each main meal. It is possible to take Panzinorm forte 20,000 with a light snack. If necessary, a single dose is doubled. Average daily dose: 1-2 tablets 3 times. Before X-ray and ultrasound examinations - 2 tablets 2-3 times a day 2-3 days before the examination. < br> < br> In children, the drug is used as directed by a doctor. Children over the age of 3 years -100 thousand.U / day (in terms of lipase). < br> The duration of treatment can vary from a single dose or several days (if the digestive process is disturbed due to dietary errors) to several months or years (if permanent replacement therapy is necessary).

Dosage (volume) of the substance in the preparation

:

pancreatin (porcine) (with enzyme activity: lipase 20,000 Eur.Pharm., amylase 12,000 Eur.Pharm. and drotease 900 U. Eur.Pharm.) 269.12 mg - 279.44 mg (15% an excess of pancreatin is caused by technical losses in the production process. 10% excess of PA

Information on technical characteristics, delivery set, country of manufacture