Creon 25000 capsules. kish.rastv. fl.p / e 50 pc

Description

Composition
Active substance:
1 capsule contains: pancreatin – 300 mg, which corresponds to 25000 units Eur.
F. lipase, 18,000 units Heb.
F. amylase 1000 U Heb. F. protease.
Excipients:
Macrogol 4000 – 75.00 mg hypromellose phthalate – 112.68 mg, dimethicone 1000 – 2.69 mg Cetyl Alcohol – 2.37 mg of triethyl citrate – 6.26 mg. Hard gelatin capsule: gelatin – 95.08 mg, colorant ferric oxide red (E 172) – 0.46 mg Iron oxide yellow dye (E 172) – 0.08 mg titanium dioxide (E 171) – 0.19 mg sodium lauryl sulfate – 0.19 mg.
Description:
Hard gelatin capsules №0, consisting of orange-brown opaque cap and a colorless transparent body. Contents of capsules – minimicrospheres light brown.
Product form:
Enteric capsules 25,000 IU. 20, 50 or 100 capsules in a bottle made of polyethylene of high density with white polypropylene screw cap c control of the first opening. On the bottle label paste. 1 bottle together with instructions for use in a cardboard pack.
Contraindications
Hypersensitivity to pancreatin porcine origin or one of the auxiliary substances, acute pancreatitis, acute exacerbation of chronic pancreatitis.
Dosage
25,000 IU
Indications
Substitution therapy failure of exocrine pancreatic function in children and adults. Insufficiency of the exocrine pancreas function is associated with various diseases of the gastrointestinal tract, most commonly found at: – cystic fibrosis, – chronic pancreatitis – after operations on pancreas, – after gastrectomy, – pancreas cancer – partial gastrectomy (e.g. Billroth II), – ductal obstruction of the pancreas or common bile duct (e.g., due to tumors), – Shvahmana Diamond syndrome.
To avoid complications be used only after consulting a doctor.
Interaction with other drugs
Interaction studies have been conducted.
Overdose
Symptoms: hyperuricosuria and hyperuricemia. Treatment: removal of the drug, symptomatic therapy.
pharmachologic effect
Pharmacological group:
Digestive enzymatic means.
Pharmacodynamics:
Enzyme preparation improves digestion. Pancreatic enzymes included in the formulation, facilitate cleavage of proteins, fats, carbohydrates, leading to their complete absorption in the small intestine.
Kreon® 25000 contains porcine pancreatin in the form minimicrospheres coated with an enteric (acid resistant) shell gelatin capsules. The capsules dissolve rapidly in the stomach releasing hundreds minimicrospheres. This principle is designed to thoroughly mix minimicrospheres the intestinal contents, and, ultimately, a better distribution of enzymes after their release in the intestinal contents.
When minimicrospheres reach the small intestine, the enteric coat is destroyed rapidly (at pH> 5,5), is released enzymes with lipolytic, proteolytic and amylolytic activity that leads to the splitting of fats, carbohydrates and proteins. The resulting cleavage agent then either are absorbed directly or subjected to further hydrolysis by intestinal enzymes.
Pharmacokinetics:
In animal studies have demonstrated the absence of absorption of the intact (uncleaved) enzymes, whereby classical pharmacokinetic studies were not conducted. Preparations containing pancreatic enzymes that do not require absorption to exhibit their effects. Conversely, the therapeutic activity of said drugs is fully implemented in the lumen of the gastrointestinal tract. According to their chemical structure, they are proteins and, therefore, the passage through the gastrointestinal tract exposed to proteolytic degradation as long as they are not absorbed in the form of peptides and amino acids.
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.
Prescribed the drug to pregnant women should be cautious if the expected benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
Based on animal studies, during which revealed no systematic negative impact of pancreatic enzymes, is not expected any harmful effects of the drug on the infant through breast milk. During breastfeeding can take pancreatic enzymes.
If necessary, take during pregnancy and lactation, the drug should be taken in dosages sufficient to maintain adequate nutritional status.
Conditions of supply of pharmacies
Without recipe.
side effects
Disorders of the gastrointestinal tract
Often (> 1/100,
Gastrointestinal disorders are mainly related to the underlying disease. The frequency of occurrence of these adverse events was lower or similar to that with placebo: diarrhea (often> 1/100
special instructions
Patients with cystic fibrosis treated with high doses of drugs pancreatin described stricture ileum, caecum and colon (fibrosing colonopathy). The studies carried out using the method of case-control data were not obtained, indicating the relationship between the occurrence of fibrosing colonopathy Kreon® preparation and application 25000. As a precaution, the appearance of the symptoms or unusual changes in the peritoneal cavity is necessary medical examination to exclude fibrosing colonopathy, particularly in patients who are taking a drug at a dose of more than 10,000 lipase units / kg per day.
As with all currently used drugs of porcine pancreatin Kreon® 25,000 produced from pancreatic tissue of pigs, specially bred for human consumption. Although the risk of transmission of infectious agents to man has been minimized by checking and inactivation of certain viruses during the manufacturing process, there is a theoretical risk of transmission of viral diseases, including diseases caused by new or unknown viruses. The presence of porcine viruses that can infect humans, it is impossible to eliminate completely. However, over a long period of time using porcine pancreatic extracts a single case was reported transfer of infectious disease.
Impact on the ability to drive a car and other mechanisms
Use of the drug Kreon®25000 no effect or has little effect on the ability to drive a car and mechanisms.
Storage conditions
Store at a temperature not higher than 25 ° C in a tightly closed package. Keep out of the reach of children!.
Dosing and Administration
Inside.
The dose selected individually depending on the severity of the disease and diet composition.
The capsules should be taken during or immediately after each meal (in t. H. Snacks), swallowed whole, not chewed or crush, drinking plenty of fluids.
If difficulty swallowing (e.g., young children or elderly patients) capsules gently opened, minimicrospheres added to a liquid food that does not require mastication and having a sour taste, for example, apple purees or fruit juice (pH
It is important to ensure adequate fluid intake constant patient, especially at high fluid loss. Inadequate fluid intake can lead to or enhance constipation.
The dose for adults and children with cystic fibrosis – dose depends on body weight and should be at the beginning of treatment in 1000 lipase units / kg per meal for children under four years old, and 500 lipase units / kg at the time of eating for children over four years. – The dose should be determined depending on the severity of symptoms, test results of steatorrhea and maintenance of adequate nutritional status. – In most patients the dose should remain less than or not more than 10,000 lipase units / kg body weight per day, or 4,000 lipase units / g of fat consumed.
The dose when other conditions involving pancreatic exocrine insufficiency
The dose should be set taking into account the individual characteristics of the patient, which include the degree of insufficiency of digestion and fat content in food. The dose that requires a patient, together with a main meal ranges from 25,000 to 80,000 IU of lipase, and during reception snack – half of the individual dose.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist