Exocrine pancreatic insufficiency in children, adolescents and adults often associated, but not limited to: cystic fibrosis (cystic fibrosis), chronic pancreatitis, pancreatectomy (pancreatectomy), gastrectomy (gastrectomy), pancreatic cancer, condition after anastomosis gastrointestinal (e.g., Billroth II gastroenterostomy), narrowing of the pancreatic duct or common bile duct (eg due to cancer), Shwachman-Diamond syndrome or condition after an acute pancreatitis attack and initiation of enteral or oral nutrition.
Composition:
1 capsules of 10,000 entero contains 150 mg of Pancreatin with the enzyme content: 10,000 U. Ph. Eur. lipase, 8,000 U. Ph. Eur. amylases and 600 U. Ph. Eur. proteases. 1 capsules, 25,000, contain 300 mg of pancreatin with an enzyme content of 25,000 U. Ph. Eur. lipase, 18,000 j. Ph. Eur. Amylase, 1,000 U. Ph. Eur. proteases. 1 capsules, 40,000, contain 400 mg pancreatin with an enzyme content of 40,000 U. Ph. Eur. lipase, 25,000 U. Ph. Eur. amylases, 1,600 U. Ph. Eur. proteases.
Action:
The drug contains pork pancreatin in the form of minimosospheres in the enteric coating, placed in a gelatin capsule. After dissolving the capsule, the minimosphere mixes with the nutritional content (multiple dose formula), then in the small intestine (pH> 5.5) their shell dissolves and the enzymes with lipolytic, amylolytic and proteolytic activity are released.
Contraindications:
Hypersensitivity to pork pancreatin or other ingredients of the preparation.
Precautions:
In patients with cystic fibrosis of pancreas receiving high doses of Pancreatin, narrowing of the ileocecal segment and large intestine (fibrotic colonopathy) was observed. As a precaution, any unusual abdominal symptoms or changes in existing symptoms should be examined in order to rule out possible fibrotic colonopathy, especially if the patient accepts more than 10,000 J.Ph.Eur. lipase / kg / day. It can not be completely ruled out the presence in the pork from which the medicine is obtained, viruses that can infect people. However, despite the long time of use, no cases of transmission of the infectious disease have been reported as a result of receiving pork-derived pancreatin extracts. During treatment, adequate hydration should be provided. Chewing and chewing on minimicospheres and mixing with food or liquid with a pH> 5.5 may destroy the protective enteric coating and cause the enzymes to be released too early in the mouth, which leads to reduced effectiveness and irritation of the oral mucosa. Care should be taken not to hold the capsules in the mouth.
Pregnancy and lactation:
Caution should be exercised when using the drug in pregnant women. Pancreatic enzymes can be used during breastfeeding.
Side effects:
Very common: abdominal pain. Common: nausea, vomiting, constipation, bloating, diarrhea. Uncommon: rash. Not known: narrowing of the ileocecal segment and large intestine (fibrotic colonopathy), pruritus, urticaria, hypersensitivity reactions (anaphylactic reactions).
Dosage:
Orally.Cystic fibrosis of the pancreas: at the beginning of 1000 U / kg / pysy in children under 4 years and 500 U of lipases / kg / pysy in children over 4 years of age; in most patients the dose should be less or should not exceed 10,000 U. Ph. Eur. lipase / kg / day or 4,000 IU lipase / g fat consumed; dosage should be adjusted taking into account the severity of the disease, control of fatty diarrhea and maintenance of good nutritional status.Other disorders associated with exocrine pancreatic insufficiency: the dose for the main meal is 25,000-80,000 U. Ph. Eur. lipase, in the case of snacks between meals, half of an individually determined dose; the dosage should be adjusted to the individual needs of each patient depending on the severity of the digestive disorders and the fat content in the food. The capsules should be swallowed whole, during meals or immediately after a meal, with liquid.If swallowing the capsule is difficult, you can open it and add the minimosphere to acidic, soft food or liquid (at pH <5.0), eg apple mousse, yogurt or fruit juice (eg apple, orange or pineapple), the mixture should be immediately use.
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