Storage:
active substance: pancreatin;
1 tablet|tablet| contains pancreatin 384 mg with an activity of at least 10,000 amylolytic IU (Ph. Eur. U.), 14,000 lipolytic IU, 800 proteolytic IU;|contains|
excipients: lactose, monohydrate; microcrystalline cellulose, croscarmellose sodium, crospovidone, povidone, colloidal anhydrous silicon dioxide, magnesium stearate, polyethylene glycol, azorubin (E 122); dry mixture “Acryl-eze white”, containing talc, titanium dioxide (E 171), methacrylate copolymer, sodium lauryl sulfate, sodium hydrogen carbonate, silicon dioxide.
Pharmaceutical form. Film-coated tablets, enteric-soluble.
Main physico-chemical properties: tablets|pills|, covered with a shell, round in shape with a biconvex surface, light pink in color, with a weak specific smell. The cross section shows two layers.
Pharmacological properties.
Pharmacodynamics. A polyenzyme preparation that promotes digestion. The composition of the drug includes the main pancreatic digestive enzymes: lipase, α-amylase, proteases (trypsin and chymotrypsin|), which do|does, reveals, does| lipolytic, amylolytic and proteolytic effect, enhances|enhances| breakdown of proteins, carbohydrates and fats in the proximal duodenum parts|parts| of the small intestine, which contributes to their more complete|complete| absorption Improves the functional state of the digestive tract and normalizes digestion processes.
Pills|pills| have a protective membrane insoluble in the acidic contents of the stomach, which prevents the destruction of pancreatic enzymes under the action of gastric juice. Pancreatic enzymes are active only|only| in an alkaline environment and are released from|from| of the dosage form in an alkaline environment small intestine, acting in the intestinal lumen.
Pharmacokinetics. Enzymes included in the composition of the drug are not absorbed in the digestive tract, so they are not detected in the systemic bloodstream; are inactivated in the process of hydrolysis and digested. A small part of enzymes that have not undergone hydrolysis is released in an unchanged form with|with| feces
Clinical characteristics.
Indication.
– Replacement therapy for exocrine pancreatic insufficiency: chronic pancreatitis, conditions after pancreatectomy|, pancreatic cancer|irradiation|, dyspepsia.
– Flatulence, diarrhea of non-infectious origin.
– Maldigestion (state after resection of the stomach and small intestine).
– In order to improve|improve| digestion of food in|in, near| persons|faces, faces| with|with| normal function of the digestive tract in the case of disorders of the chewing function, when using|use, use| difficult to digest vegetable, fatty or unusual food; consuming excessive amounts of food.
– Preparation for x-ray examination and ultrasound diagnostic examinations organs of the abdominal cavity (intestinal degassing).
Contraindication. Hypersensitivity to porcine pancreatin/other components of the drug, |intolerance|acute pancreatitis, exacerbation of chronic pancreatitis, intestinal obstruction.
Pharmacotherapeutic group. Means that improve digestion, including enzymes. Polyenzyme preparations.
Method of application and dosage. Take internally during or immediately after eat|eat|, tablets should be swallowed whole, without chewing, with plenty of liquid (water, fruit juices). The dosage of the drug is based on the individual needs of the patient and depends on his age, the degree of indigestion and the composition of the food.
It is recommended to take 1-2 tablets (14000-28000 MO of lipase) during each meal. However, it is possible that some patients may need to increase the dose by 1.5-2 times or even more to eliminate steatorrhea and maintain proper nutritional status. It is not recommended to exceed a dose of 15,000-20,000 MO of lipase/kg of body weight/day.
The duration of treatment can vary from several days (in case of digestive disorders due to consumption of excessive amounts of food) to several months or even years (if constant replacement therapy is required).
Children. The drug is recommended for use by children aged 4 and over.
Overdose. Symptoms: hyperuricosuria|, hyperuricemia; in|in, near| children – constipation.
Treatment: discontinuation of the drug, adequate hydration, symptomatic therapy.
Adverse reactions. From the side of the digestive system: very rarely – nausea, vomiting, flatulence, diarrhea, discomfort in the epigastric area, change in the nature of stools.
Hypersensitivity reactions (including rash, itching, sneezing, lacrimation, bronchospasm, urticaria, anaphylactic reactions), perianal irritation are possible.
Expiration date. 3 years.
Storage conditions. Store in the original packaging at a temperature not higher than 25 °C. Keep out of the reach of children.
Packaging. Tablets No. 10, No. 10´2, No. 10´5 in blisters in a box.
Release category. Without a prescription.
Producer. Limited Liability Company “Pharmaceutical Company “Zdorovya”.
Limited liability company
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