ÈÓÑ«¡® 10000

General characteristics. Structure:

1 capsule contains:

Active agent: Pancreatinum — 150 mg that corresponds:

10000 PIECES Evr. T. lipases,

8000 PIECES Evr. T. amylases,

600 PIECES Evr. T. proteases.

Excipients: a macrogoal of 4000 — 37,50 mg, gipromelloza phthalate — 56,34 mg, диметикон 1000 — 1,35 mg, cetyl alcohol — 1,18 mg, triethyl citrate — 3,13 mg.

Solid gelatin capsule: gelatin — 60,44 mg, dye ferrous oxide red (E 172) — 0,23 mg, dye ferrous oxide yellow (E 172) — 0,05 mg, dye ferrous oxide black (E 172) — 0,09 mg, titanium dioxide (Е 171) — 0,07 mg, sodium lauryl sulfate — 0,12 mg.

Description: the solid gelatin capsules No. 2 consisting of a brown opaque lid and the transparent colourless case.

Contents of capsules — minimicrospheres of light brown color.

Pharmacological properties:

Pharmacodynamics. The fermental drug improving digestion processes. The pancreatic enzymes which are a part of drug facilitate the proteolysis, fats, carbohydrates that leads to their full absorption in a small bowel.

ÈÓÑ«¡® 10000 contains pork Pancreatinum in the form of the minimicrospheres covered with a kishechnorastvorimy (acid resisting) cover in gelatin capsules. Capsules are quickly dissolved in a stomach, releasing hundreds of minimicrospheres. This principle is developed for the purpose of careful hashing of minimicrospheres with intestinal contents, and, eventually, the best distribution of enzymes after their release in intestines contents. When minimicrospheres reach a small bowel, the kishechnorastvorimy cover quickly collapses (at pH> 5,5), there is a release of enzymes to lipolytic, amylolytic and proteolytic activity that leads to splitting of fats, carbohydrates and proteins. The substances received as a result of splitting then either are absorbed directly, or are exposed to further hydrolysis by intestinal enzymes.

Pharmacokinetics. In researches on animals lack of absorption of the intact (not split) enzymes was shown owing to what classical pharmacokinetic researches were not conducted. The drugs containing pancreas enzymes do not need absorption for manifestation of the effects. On the contrary, therapeutic activity of the specified drugs is fully implemented in a digestive tract gleam. On the chemical structure they are proteins and, in this regard, when passing through digestive tract are exposed to proteolytic splitting until they are not absorbed in the form of peptides and amino acids.

Indications to use:

Replacement therapy of the insufficiency of exocrine function of the pancreas at children and adults caused by various diseases of digestive tract and which is the most often found at:
- mucoviscidosis;
- chronic pancreatitis;
- after pancreas operation;
- after a gastrectomy;
- pancreatic cancer;
- partial resection of a stomach (for example, Billroth of II);
- obstructions of pancreat ducts or the general bilious channel (for example, owing to a new growth);
- Shvakhman's syndrome — Daymonda;
- a state after an attack of acute pancreatitis and resuming of food.

In order to avoid complications to apply only after consultation with the doctor.

Route of administration and doses:

Inside.

Doses of drug select individually depending on disease severity and structure of a diet.

Capsules should be accepted in time or right after each meal (including light meal), to swallow entirely, not to break and not to chew, washing down with enough liquid.

At the complicated swallowing (for example, at small children or patients of advanced age) capsules carefully open, and minimicrospheres add to the soft food which is not demanding a chewing and having acid taste (pH <5,5), or accept with the liquid which also have acid taste (pH <5,5). For example, the minimicrosphere can be added to apple puree, yogurt or fruit juice (apple, orange or pineapple) with pH less than 5,5. It is not recommended to add contents of capsules to hot food. Any mix of minimicrospheres with food or liquid is not subject to storage, and it should be accepted at once after preparation.

Razmelcheniye or chewing of minimicrospheres, and also their mixing with food or liquid with pH more than 5,5 can destroy their protective kishechnorastvorimy cover. It can lead to early release of enzymes in an oral cavity, to decrease in efficiency and irritation of mucous membranes. It is necessary to be convinced that in a mouth there is no minimicrosphere left.

It is important to provide sufficient constant reception of liquid by the patient, especially at the raised liquid loss. Inadequate consumption of liquid can lead to emergence or strengthening of a lock.

Dose for adults and children at a mucoviscidosis
 
The dose depends on body weight and has to make in an initiation of treatment of 1000 lipazny units/kg on each meal for children is younger than four years, and 500 lipazny units/kg during meal for children are more senior than four years and adults.
The dose should be defined depending on expressiveness of symptoms of a disease, results of control of a steatorrhea and maintenance of the adequate nutritive status.
The dose has to remain with most of patients less or not exceed 10000 lipazny units/kg of body weight a day or 4000 lipazny units/g of the consumed fat.

Dose at other states which are followed by exocrine insufficiency of a pancreas

The dose should be established taking into account specific features of the patient to which degree of insufficiency of digestion and content of fat in food belong. The dose which is required to the patient together with the main meal varies from 25000 to 80000 PIECES of a lipase, and during reception of light meal — a half of an individual dose.

At children drug has to be used according to appointment of the doctor.

Features of use:

At the patients with a mucoviscidosis receiving high doses of drugs of Pancreatinum strictures of an ileal, blind and large intestine (a fibroziruyushchy colonopathy) are described. As a precautionary measure, at emergence of unusual symptoms or changes in an abdominal cavity medical examination is necessary for an exception of a fibroziruyushchy colonopathy, especially at patients who accept drug in a dose more than 10000 lipazny units/kg a day.

As well as all drugs of pork Pancreatinum used now, Креон® 10000 it is made from tissue of a pancreas of the pigs who are specially grown up for consumption. Though the probability of transfer of the infectious agent to the person was minimized by means of check and an inactivation of certain viruses in the course of production, there is a theoretical risk of transfer of a viral disease, including the diseases caused by new or unknown viruses. Existence of pork viruses which can infect the person cannot be excluded completely. However for a long span of use of extracts of a pancreas of pigs of any case of transfer of an infectious disease it was not registered.

Influence on ability to driving and other mechanisms

Use of the drug Креон® 10000 does not influence or exerts insignificant impact on ability to driving and mechanisms.

Side effects:

Disturbances from digestive tract

Very often (≥1/10): pain in a stomach.

Often (≥1/100, <1/10): nausea, vomiting, lock, abdominal distention, diarrhea.

Frequency is unknown: strictures of an ileal, blind and large intestine (fibroziruyushchy colonopathy).

Gastrointestinal frustration are connected mainly with a basic disease. Frequency of emergence of such undesirable reactions as pain in a stomach and diarrhea was lower or similar to that at placebo use. Strictures of an ileal, blind and large intestine (a fibroziruyushchy colonopathy) were observed at the patients with a mucoviscidosis receiving high doses of drugs of Pancreatinum (see the section "Special Instructions").

Disturbances from skin and hypodermic fabrics

Infrequently (≥1/1000, <1/100): rash.

Frequency is unknown: itch, urticaria.

Disturbances from immune system

Frequency is unknown: hypersensitivity (anaphylactic reactions).

Allergic reactions were observed preferential from integuments, but were noted as well other displays of an allergy. Messages on these side effects were received during post-marketing use and had spontaneous character. For exact assessment of frequency of cases of the available data it is not enough.

At use for children any specific undesirable reactions were not noted. Frequency, type and severity of undesirable reactions at children with a mucoviscidosis were similar to those at adults.

Interaction with other medicines:

Researches on interaction were not conducted.

Contraindications:

Hypersensitivity to any of drug components.

Use at pregnancy and during breastfeeding

Pregnancy

Clinical data on treatment of pregnant women the drugs containing pancreas enzymes no. During the researches on animals absorption of enzymes of a pancreas of a pork origin therefore toxic impact on reproductive function and fetation is not supposed is not revealed.

It is necessary to appoint drug to pregnant women with care if the estimated advantage for mother exceeds potential risk for a fruit.

Breastfeeding period

Proceeding from researches on animals during whom the systematic negative impact of enzymes of a pancreas is not revealed no adverse effect of drug on the baby through breast milk is expected.

During feeding by a breast it is possible to accept pancreas enzymes.

In need of inclusion in time of pregnancy or feeding by a breast, drug should be accepted in the doses sufficient for maintenance of the adequate nutritive status.

Overdose:

Symptoms: hyper uricosuria and hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

Storage conditions:

To store at a temperature not over 25 ºС in densely closed packaging. To store in the place, unavailable to children! Period of validity 2 years. A period of validity after the first opening of a bottle — 3 months. Not to apply after the period of validity specified on packaging.

Issue conditions:

Without recipe

Packaging:

Capsules kishechnorastvorimy 10000 PIECES. On 20, 50 or 100 capsules in a bottle from polyethylene of high density of white color with the screw-on cover from polypropylene with control of the first opening. On a bottle paste the label. On 1 bottle together with the application instruction in a pack cardboard.