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Pancreatin enteric coated capsule (deweitong)

Common name:
Pancreatin Enteric-coated Capsules
Product No.:
B14200042458
Approval No.:
H20171150 (original h20160180)
Main functions:
Treatment of pancreatic exocrine insufficiency in children and adults. Pancreatic exocrine insufficiency is common in (but not limited to) ·Cystic fibrosis and chronic pancreatitis ·After pancreatectomy ·After gastrectomy Pancreatic cancer ·After gastrointestinal bypass reconstruction (e.g. after Bi ⅱ subtotal gastrectomy) ·Obstruction of pancreatic duct or common bile duct (as caused by tumor) ·Simon Sheehan syndrome
Product specification:
0.15g * 20s (per pass)
Manufacturer:
Abbott Laboratories GmbH (Germany)
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Product name Pancreatin enteric coated capsule (deweitong)
Main raw materials This product is a mixture of various enzymes extracted from porcine pancreas, mainly trypsin, pancreatic lipase and pancreatic amylase.
Main role Treatment of pancreatic exocrine insufficiency in children and adults. Pancreatic exocrine insufficiency is common in (but not limited to) ·Cystic fibrosis and chronic pancreatitis ·After pancreatectomy ·After gastrectomy Pancreatic cancer ·After gastrointestinal bypass reconstruction (e.g. after Bi ⅱ subtotal gastrectomy) ·Obstruction of pancreatic duct or common bile duct (as caused by tumor) ·Simon Sheehan syndrome
Suitable population
Product specification 0.15g * 20s (per pass)
Usage and dosage The specific dose should vary from person to person and be determined according to the severity of the disease and dietary structure. It is recommended to take 1 / 2 or 1 / 3 of the total amount (see below) orally at the beginning of eating, and the remaining dose should be taken during eating. This product should be swallowed with water, not crushed or chewed. If it is difficult to swallow the whole capsule (such as children or the elderly), carefully open the capsule, mix pancreatin particles with liquid (if juice) and drink it together, but the mixed solution should be taken immediately and cannot be preserved. Demetone can be used as a therapeutic drug for Jewish and Muslim patients. Patients with cystic fibrosis: According to the recommendations of the cystic fibrosis consensus conference, the case-control study of the American Cystic Fibrosis Foundation and the results of the case-control study in the UK, the following doses are recommended for trypsin replacement therapy: Children under 4 years old were given 1000 units of pancreatic lipase per kilogram of body weight per meal. Patients over 4 years old were given 500 units of pancreatic lipase per kilogram of body weight per meal. The dose should be adjusted according to the severity of the disease, the control of fatty dysentery and the need to maintain good nutritional status. For most patients, the daily dose should be less than or no more than 10000 units of pancreatic lipase / kg body weight. Other pancreatic exocrine insufficiency diseases: The specific dose should vary from person to person and be determined according to the degree of digestive dysfunction and the fat content in the diet. The usual starting dose is 1-2 pancreatin capsules per meal or each meal. The dosage used should minimize fatty dysentery and maintain good nutritional status. The commonly used clinical dose is: take at least 2-4 pancreatin capsules per meal, and take at least 2 pancreatin capsules orally each time.
manufacturing enterprise Abbott Laboratories GmbH (Germany)
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[drug name]

   Common name: Pancreatin Enteric-coated Capsules

   Trade name: Pancreatin enteric coated capsule (deweitong)

   English Name: Pancreatin Enteric-coated Capsules

   Pinyin full code: YiMeiChangRongJiaoNang(DeMeiTong)

[main ingredients] This product is a mixture of various enzymes extracted from porcine pancreas, mainly trypsin, pancreatic lipase and pancreatic amylase.

[ingredients]

   Chemical name:

   Molecular formula:

   Molecular weight:

[character] This product is a brown and colorless transparent two-color capsule, and the content is brown particles.

[indications / functional indications] Treatment of pancreatic exocrine insufficiency in children and adults. Pancreatic exocrine insufficiency is common in (but not limited to) ·Cystic fibrosis and chronic pancreatitis ·After pancreatectomy ·After gastrectomy Pancreatic cancer ·After gastrointestinal bypass reconstruction (e.g. after Bi ⅱ subtotal gastrectomy) ·Obstruction of pancreatic duct or common bile duct (as caused by tumor) ·Simon Sheehan syndrome

[specification and model] 0.15g * 20s (per pass)

[usage and dosage] The specific dose should vary from person to person and be determined according to the severity of the disease and dietary structure. It is recommended to take 1 / 2 or 1 / 3 of the total amount (see below) orally at the beginning of eating, and the remaining dose should be taken during eating. This product should be swallowed with water, not crushed or chewed. If it is difficult to swallow the whole capsule (such as children or the elderly), carefully open the capsule, mix pancreatin particles with liquid (if juice) and drink it together, but the mixed solution should be taken immediately and cannot be preserved. Demetone can be used as a therapeutic drug for Jewish and Muslim patients. Patients with cystic fibrosis: According to the recommendations of the cystic fibrosis consensus conference, the case-control study of the American Cystic Fibrosis Foundation and the results of the case-control study in the UK, the following doses are recommended for trypsin replacement therapy: Children under 4 years old were given 1000 units of pancreatic lipase per kilogram of body weight per meal. Patients over 4 years old were given 500 units of pancreatic lipase per kilogram of body weight per meal. The dose should be adjusted according to the severity of the disease, the control of fatty dysentery and the need to maintain good nutritional status. For most patients, the daily dose should be less than or no more than 10000 units of pancreatic lipase / kg body weight. Other pancreatic exocrine insufficiency diseases: The specific dose should vary from person to person and be determined according to the degree of digestive dysfunction and the fat content in the diet. The usual starting dose is 1-2 pancreatin capsules per meal or each meal. The dosage used should minimize fatty dysentery and maintain good nutritional status. The commonly used clinical dose is: take at least 2-4 pancreatin capsules per meal, and take at least 2 pancreatin capsules orally each time.

[adverse reactions] In clinical trials, more than 900 patients received each pass. The most frequently reported adverse reactions were mild to moderate gastrointestinal discomfort. The following adverse reactions have been reported in clinical trials. [see instructions for details].

[taboo] It is forbidden for those who are known to be allergic to porcine pancreatic enzyme preparation or any excipient of this product.

[precautions] 1. Special warning: cystic fibrosis patients taking high-dose trypsin preparation have reported ileocecal and large intestine stenosis (colonic fibroid lesions). As a preventive measure, especially when the dose of pancreatic lipase per kilogram of body weight exceeds 10000 units per day, if there are abnormal abdominal symptoms or changes in abdominal symptoms, Medical evaluation should be performed to exclude the possibility of colonic fibroid lesions. 2. This product does not affect driving or mechanical operation.

[medication for children] Please refer to [usage and dosage]. Children with cystic fibrosis have reported ileocecal, colorectal stenosis and colitis after taking high-dose trypsin preparation.

[medication for elderly patients] In the patients with malabsorption caused by insufficient pancreatic exocrine secretion, no special population to be restricted was found.

[medication for pregnant and lactating women] Pregnancy There is no clinical data on the use of trypsin in pregnant women. Animal studies did not show the absorption of trypsin. Therefore, no teratogenic or reproductive toxicity was predicted. Caution for pregnant women.

[drug interaction] drugInteractions

[drug overdose] Excessive administration of trypsin may promote hyperuricemia and hyperuricemia.

[pharmacology and toxicology] The capsule disintegrates in the stomach and releases ultrafine particles, which are mixed with food and distributed in chyme. When the particles reach the small intestine, the particle coating disintegrates rapidly (pH > 5.5) and releases the decomposition enzymes of fat, starch and protein. When digesting fat, starch and protein, they are directly absorbed or further hydrolyzed by small intestinal enzymes.

[pharmacokinetics] Animal studies did not show complete absorption of enzymes, so typical pharmacokinetic studies were not carried out. Pancreatin preparations exert full efficacy in the gastrointestinal tract without absorption. In addition, since trypsin itself is a protein, it is finally absorbed in the form of peptides and amino acids after being decomposed by proteolytic enzymes in the gastrointestinal tract.

[storage] Sealed and placed in a dry place at room temperature

[packaging] 20 capsules / box

[validity period] 24 months

[executive standard]

[approval No.] H20171150 (original h20160180)

[manufacturer] Abbott Laboratories GmbH (Germany)

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