PANCITRAT

Active material: Pancreatin
When ATH: A09AA02
CCF: The enzyme preparation
ICD-10 codes (testimony): E84, K30, K83.1, K86.1, K86.8, K90.3, K91.2, K91.5, Z51.4
When CSF: 11.05
Manufacturer: NORDMARK PHARMACEUTICALS GmbH & Co.KG (Germany)

Pharmaceutical form, composition and packaging

Capsules hard gelatin, size №2, oblong, with a brown cap and a colorless transparent casing; the contents of capsules — convex mikrotabletki, covered with whitish-gray.

1 caps.
pancreatin10 th. ED
with enzymatic activity:
lipase10000 ED. Ph. EUR.
amilazы9000 ED. Ph. EUR.
proteases500 ED. Ph. EUR.

Excipients: microcrystalline cellulose, krospovydon, aэrosyl, magnesium stearate, a copolymer of methacrylic acid and ethyl acrylate, triэtiltsitrat, talc, simethicone 23% emulsion, montan glycol wax, gelatin, Titanium dioxide, iron oxide red, iron oxide black.

20 PC. – bottles (1) – packs cardboard.
50 PC. – bottles (1) – packs cardboard.
100 PC. – bottles (1) – packs cardboard.

Capsules hard gelatin, size №0, oblong, with a brown cap and a colorless transparent casing; the contents of capsules — convex mikrotabletki, covered with whitish-gray.

1 caps.
pancreatin25 th. ED
with enzymatic activity:
lipase25000 ED. Ph. EUR.
amilazы22500 ED. Ph. EUR.
proteases1250 ED. Ph. EUR.

Excipients: microcrystalline cellulose, krospovydon, aэrosyl, magnesium stearate, a copolymer of methacrylic acid and ethyl acrylate, triэtiltsitrat, talc, simethicone 23% emulsion, montan glycol wax, gelatin, Titanium dioxide, iron oxide red, iron oxide black.

20 PC. – bottles (1) – packs cardboard.
50 PC. – bottles (1) – packs cardboard.
100 PC. – bottles (1) – packs cardboard.

 

Pharmacological action

The enzyme preparation. Compensates for lack of exocrine pancreatic function, provides proteoliticescoe, amiloliticescoe and lipolytic effect. Improves functional status syndrome, normalizes digestion.

Included in the pancreatin enzymes (lipase, alpha-amylase, trypsin, ximotripsin) contribute to the breakdown of proteins to amino acids, fats to glycerol and fatty acids, starch to dextrin and monosaccharide. Trypsin inhibited stimulirovannuyu secretion of the pancreas, exerting analgesic action.

Capsules contain mikrotabletki, enteric coated. Pancreatic enzymes are released from the dosage form in alkaline Wednesday thin intestine, since protected against the action of the gastric juice-coated.

 

Pharmacokinetics

The farmakokinetike drug Pancitrat not available.

 

Testimony

-substitution therapy in external pancreatic insufficiency (incl. in chronic pancreatitis, condition after irradiation, dyspepsia, Remhelda syndrome, mukovystsydoze, meteorism, diarrhea noninfectional, After pankreatjektomii);

-If there is a violation of the assimilation of food after stomach resection and/or thin intestine;

— to improve food digestion in those with normal DIGESTIVE function in case of errors in nutrition (incl. the irregular nutrition, use a large quantity of food, consuming fatty foods, violations of chewing function, sedentary lifestyle, prolonged immobilization);

- Preparation for X-ray and ultrasound of the abdominal cavity.

 

Dosage regimen

The drug is taken orally during or after a meal, with liquid squeezed liquid non-alkaline (water, fruit juices).

Dose is determined depending on the degree of digestive disorders. Adults appoint 1-2 caps. (by 10 000 ED) or 1 caps. (by 25 000 ED) 3 times / day. In older children 6 years the drug is applied by a physician, dose determined individually.

The duration of treatment can vary from a few days (If there is a violation of the digestive process due to errors in the diet) up to several months or years (If you need constant replacement therapy).

 

Side effect

From the digestive system: rarely – diarrhea, constipation, the feeling of discomfort in the stomach, nausea (the causal link of development of these reactions to the action of pancreatin is not installed, Since these phenomena are related to symptoms of deficiency vneshnesecretorna the pancreas).

Prolonged use of high doses: perhaps – giperurikozurija, hyperuricemia.

In cystic fibrosis in case of exceeding the necessary dose of pancreatin: perhaps – stricture (fibrous colonopathy) in the ileocekalnom Division of the ascending colon.

When used in high doses in children: perhaps – perianalnoe irritation, irritation of the mucous membranes of the oral cavity.

Other: allergic reactions.

 

Contraindications

- Acute pancreatitis;

- Exacerbation of chronic pancreatitis;

- Children up to age 6 years;

- Hypersensitivity to the drug.

 

Pregnancy and lactation

Application of pancreatin in pregnancy and lactation (breast-feeding) not contraindicated.

 

Cautions

In cystic fibrosis is not recommended the use of pancreatin in high doses due to increased risk of strictures (fibrous colonopathy).

Dose should be adequate to the number of enzymes, necessary for fat intake, taking into account the quality and quantity of food consumed.

Use in Pediatrics

Do not use this drug in Children up to 6 years.

 

Overdose

Symptoms: giperurikozurija, hyperuricemia; children – constipation.

Treatment: removal of the drug, simptomaticheskaya therapy.

 

Drug Interactions

When applying pancreatin may reduce intake of iron and folic acid.

The simultaneous use of antacids, containing calcium carbonate and/or magnesium hydroxide, could result in diminishing the effectiveness of pancreatin.

 

Conditions of supply of pharmacies

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

 

Conditions and terms

The drug should be stored out of reach of children, in dry place at a temperature of no higher than 20° c. Shelf life – 3 year.

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