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Kreazim 10 000; 20 000 капс. No. 20

Препарат Креазим 10 000 ; 20 000 капс. №20. ЗАО "Лекхим-Харьков" Украина


Producer: CJSC Lekhim-Kharkiv Ukraine

Code of automatic telephone exchange: A09AA02

Release form: Firm dosage forms. Capsules.

Indications to use: Pancreatitis. Shvakhmana-Daymond's syndrome. Cirrhosis. Mucoviscidosis. Pancreatic cancer. Cholestatic hepatitis. Cirrhosis.


General characteristics. Structure:

Active ingredients: 1 capsule contains Pancreatinum 0,14 g (Kreazim 10000) that corresponds to activity not less: 10 000 PIECES of Ph. Eur. lipases, 8 000 PIECES of Ph. Eur. amylases and 600 PIECES of Ph. Eur. proteases, or 0,28 g (Kreazim 20000) that corresponds to activity not less: 20 000 PIECES of Ph. Eur. lipases, 16 000 PIECES of Ph. Eur. amylases and 1 200 PIECES of Ph. Eur. proteases; excipients: коликоат MAE-30 DP (methacrylic acid – ethyl acrylate copolymer (1:1) dispersions of 30%), симетикон, talc, was trietit by citrate, a sugar krupka.




Pharmacological properties:

The means of replacement therapy applied at digestive disturbances. Fermental drug. Fills shortage of enzymes of a pancreas (a lipase, amylase and protease) which hydrolyze respectively vegetable and animal fats (to glycerin and fatty acids), polysaccharides (to dextrins and monosaccharides) and proteins (to dipeptides and amino acids), promoting fuller absorption of feedstuffs in a small intestine. Improves digestion processes.
The special dosage form of drug allows to avoid decrease of the activity of enzymes owing to an inactivation a gastric juice.
The drug granules which are contained in the capsule and having an acid resisting covering evenly mix up with contents of a stomach and get into a duodenum. Bystry release and activation of enzymes begins in her subacidic or neutral environment where the covering of granules breaks up.
Granules are stable in the gastric environment at рН lower than 5,5. Are steady in the presence of a gastric juice within 45 min. Release of enzymatic activity at рН 6 makes 75 – 100% during 1 h, at рН 6,8 - 100% within 30 min., at рН 8 – full release in 15 min.


Indications to use:

Replacement therapy at vneshnesekretorny insufficiency of a pancreas at chronic pancreatitis, a mucoviscidosis, pancreatectomy, a pancreatic cancer, obstruction of pancreat ducts or the general bilious channel owing to a new growth, Shvakhmana-Daymond's syndrome, at advanced age; at symptomatic therapy of disturbances of processes of digestion at a stomach resection, states after a cholecystectomia, duodeno-and a gastrostaza, biliary obstruction, cholestatic hepatitis, cirrhosis, pathology of terminal department of a small bowel, excess bacterial growth in a small bowel, errors in food.

Before an initiation of treatment consult to the doctor!
At use of drug to adhere to the recommended doses.


Route of administration and doses:

Inside, capsules should be swallowed, without chewing, washing down with enough liquid.
The dose is selected individually, depending on degree of insufficiency of function of a pancreas and structure of a diet.
It is recommended to accept 1/3 or ½ single doses at the beginning of food, other part – during food.
In an initiation of treatment drug is appointed on 10000-20000 PIECES of a lipase with the main meal. For reduction of a steatorrhea and maintenance of an optimum condition of the patient increase in a dose is possible: the dose with the main meal (a breakfast, a lunch and a dinner) makes 20000-70000 PIECES of a lipase, during reception of light meal – 5000-20000 PIECES of a lipase.
At a mucoviscidosis the dose depends on body weight and makes in an initiation of treatment at children 4 years – 1000 lipazny PIECES/kg are younger, 4 years – 500 lipazny PIECES/kg are more senior during meal. The dose depends on expressiveness of symptoms of a disease, results of control of a steatorrhea and maintenance of the optimum food status. The maximum dose – 10000 lipazny PIECES/kg/days.
At difficulty of swallowing at small children or patients of senile age carefully open capsules, and granules add to the liquid food which is not demanding a prozhevyvaniye or accept with liquid. The prepared mix is not subject to storage.
Duration of treatment can vary of several days (at disturbance of process of digestion owing to errors in a diet) up to several months and even years (in need of continuous replacement therapy).
Overdose. At reception of extremely high doses of other drugs of Pancreatinum the hyperuricemia and a hyperuricuria therefore their emergence at Kreazim's overdose is potentially possible was observed. If such symptoms arise and are clinically meaning, it is necessary to resolve an issue of drug withdrawal.


Features of use:

At a mucoviscidosis the dose of drug has to be adequate to amount of enzymes which is necessary for hydrolysis of fats taking into account quality and amount of the consumed food. The children receiving prolonged treatment by drug concerning a mucoviscidosis have to be observed regularly at the specialist.
Safety of use of drug at pregnancy is studied insufficiently. Use at pregnancy and in the period of a lactation perhaps only on doctor's orders in cases if the expected effect of therapy for mother exceeds potential risk for a fruit or the child.


Side effects:

At use in average therapeutic doses side effect is observed less than in 1% of cases.
From the alimentary system: in some cases – diarrhea, a lock, a sensation of discomfort in a stomach, nausea. Allergic reactions: in some cases – skin manifestations.
In case of any undesirable phenomena consult to the doctor of rather further use of drug!


Interaction with other medicines:

If you accept any other medicines, surely consult with the doctor about a possibility of use of drug! Pancreatinum reduces iron absorption therefore at prolonged use purpose of iron preparations can be necessary for you.


Contraindications:

Hypersensitivity, acute pancreatitis, exacerbation of chronic pancreatitis.



Storage conditions:

It is not necessary to use drug after the termination of the period of validity specified on packaging. To store in dry, protected from light and the place, unavailable to children, at a temperature from 15 °C to 25 °C.

Period of validity - 2 years.


Issue conditions:

Without recipe


Packaging:

On 10 capsules in a blister strip packaging. 2 blister strip packagings in a pack from a cardboard.



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