Pangrol 25,000 caps. kish.rastv. 25000ed fl.plast 50 pc

Description

Composition
Active substance:
1 capsule contains:
Pancreatin – 356.10 mg with minimal activity: 25,000 IU of lipase amylase 22500 1250 protease units.
Excipients:
Croscarmellose sodium – 11.87 mg, Microcrystalline Cellulose – 19.77 mg Hydrogenated castor oil – 3.96 mg silica colloidal anhydrous – 1.97 mg magnesium stearate – 1.97 mg; sheath: methacrylic acid-ethyl acrylate copolymer (1: 1) 30% dispersion of -57.9 mg triethyl citrate – 5.82 mg Simethicone emulsion 30% (dry weight) – 0,036 mg; talc – 11.63 mg; capsule body: gelatin – 65.40 mg titanium dioxide (E 171) – 0.30 mg; dye Yellow iron oxide (E 172) – 0.30 mg; dye iron oxide red (E 172) – 0.02 mg; Cap: gelatin – 42,900 mg; titanium dioxide (E 171) – 0.800 mg; dye quinoline yellow (E 104) – 0.300 mg; indigo carmine (E 132) – 0.003 mg.
Description:
Opaque hard gelatin capsule of cylindrical form with hemispherical ends № 0: capsule housing pale orange capsule cap yellowish green color. The contents of capsules: minitablets cylindrical enteric coated, light beige color with a shiny surface.
Product form:
Enteric capsules, 25 000 units.
20, 50 or 100 capsules in a polypropylene bottle with a plastic lid provided with a desiccant.
1 bottle together with instructions for use in a cardboard package.
Contraindications
Acute pancreatitis; exacerbation of chronic pancreatitis; hypersensitivity to pancreatin of porcine origin or to other components of the drug.
Indications
Substitution therapy insufficiency exocrine pancreatic function in children and adults under the following conditions: chronic pancreatitis; cystic fibrosis; pancreas cancer; status after surgical interventions on the pancreas and stomach (complete or partial resection of the body); after irradiation of the digestive tract, accompanied by violation of the digestion of food, flatulence, diarrhea (in combination therapy); restriction pancreatic duct, for example due to a tumor or gallstones; Shvahmana Diamond Syndrome; subacute pancreatitis; other diseases accompanied by exocrine pancreatic insufficiency.
Relative enzyme deficiency in the following conditions and situations: gastrointestinal disorders functional nature, acute intestinal infections, irritable bowel syndrome; the use of indigestible plant or fatty foods;
Preparing to X-ray and ultrasound examination of the abdominal cavity.
Interaction with other drugs
Interaction studies have been conducted.
Overdose
Symptoms: The use of high doses of pancreatic enzymes may be accompanied hyperuricosuria and hyperuricemia in patients with cystic fibrosis.
Treatment: removal of the drug, symptomatic therapy.
pharmachologic effect
Pharmacological group:
Digestive enzymatic means.
Pharmacodynamics:
The active substance Pangrol® 25000 drug is pancreatin, which is a powder of porcine pancreatic glands. Enzymes belonging to the pancreatin promote lipolysis, carbohydrate and protein, coming from the food. Pancreatin, rendering proteolytic, amylolytic and lipolytic action compensates pancreatic enzyme insufficiency, improving the functional state of the gastrointestinal tract (GIT), normalizes digestion.
Pharmacokinetics:
Gelatin capsule formulation Pangrol * 25000 dissolve rapidly in the stomach, releasing the mini-tablets coated with an enteric (acid resistant) coating. Thus, the enzymes are protected from inactivation in the acidic environment of the stomach. release form of the drug provides a mixing mini-tablets with intestinal contents and even distribution of enzymes. Dissolution shell minitablets enzymes and activation occurs at a neutral or slightly alkaline pH in the small intestine. Pancreatin is not absorbed in the intestine, it is excreted in the feces.
Pregnancy and breast-feeding
Pregnancy
Clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes are lacking. Studies in animals have not revealed absorption of pancreatic enzymes swine origin, so the toxic effects on reproduction and fetal development is not expected.
Use of the drug Pangrol 10,000 during pregnancy is possible in that case, if the expected benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
Based on animal studies, during which did not reveal the negative impact of pancreatic enzymes, is not expected any harmful effects of the drug on the child through breast milk. During breastfeeding can take pancreatic enzymes.
Conditions of supply of pharmacies
Without recipe.
side effects
Possible side effects are listed below in descending frequency of occurrence: often (> 1/100, 1/1000, 1/10000,
Disorders of the gastrointestinal tract:
Common: nausea, vomiting, and abdominal distension.
Gastrointestinal disorders are mainly associated with the underlying disease.
The frequency of occurrence of these adverse events was lower or similar to those of placebo:
Very common: pain in the abdomen; often diarrhea.
Violations of the skin and subcutaneous tissue disorders:
Rare: rash; itching, hives – to assess the frequency of these cases is not enough.
special instructions
Patients with cystic fibrosis treated with high doses of pancreatin preparations described stricture ileum, caecum and colon (fibrosing colonopathy). As a precaution, the appearance of the symptoms or unusual changes in the character of symptoms of the main disease necessary medical examination to exclude lesion of the colon, particularly in the case of the drug at a dose of more than 10000 lipase units per kg body weight per day.
Effect on the ability to road management and other mechanisms:
Pangrol® 25000 does not affect the performance of potentially hazardous activities that require attention and speed of reaction.
Storage conditions
Store at a temperature not higher than 25 C.
Drug store out of reach of children !.
Dosing and Administration
Dose Pangrol 25,000 selected individually depending on the severity of the disease, as well as the amount and composition of food intake.
Unless otherwise indicated, an adult should be 1-2 capsules preparation Pangrol® 25000 during each meal, swallowing whole (not chew), squeezed enough liquid (e.g. water glass). If the reception of an entire capsule for the patient difficult (eg small children or elderly patients) can be emptied of its contents, for example, a glass, opening the capsule by separating the lid from the body, and then take the contents of the (mini-pills), squeezed some liquid or added to a liquid food that does not require chewing (eg, applesauce or fruit juice). A mixture of the mini-tablets with food or liquid can not be stored (taken immediately after preparation).
Increasing the dose of the drug should be administered only under medical supervision, in line with the dynamics of symptoms (eg, reduction of steatorrhea, abdominal pain relief).
The daily dose of enzymes component 15000-20000 lipase units / kg body weight, not to exceed recommended.
The duration of treatment is established physician and depends on the course of the disease.
Children dosage and duration of treatment regimen determined by a doctor depending on the severity of the disease and the composition of the food at the rate of 500 – 1000 lipase units / kg of body weight of the child at every meal.
Application in cystic fibrosis
Dose Pangrol 25000 depends on body weight and shall be the beginning of treatment 1000 lipase units / kg per meal for children under 4 years of age and 500 lipase units / kg during each meal for children older than 4 years. The dose should be selected individually depending on the severity of the disease, under control of steatorrhea and support optimal diet. In most patients, the dose should not exceed 10,000 lipase units / kg body weight per day, or 4,000 lipase units / g of fat consumed.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist