Pharmacological properties

Pharmacodynamics. medicament contains Pancreatinum from a pancreas of pigs in the form of covered with an enterosoluble cover (steady in acidic environment) microtablets in gelatin capsules. capsules are quickly dissolved in a stomach, releasing microtablets by the multidose principle that provides good hashing with stomach contents, transportation from a stomach together with its contents and after release sufficient distribution of enzymes in intestines contents. when microtablets get into a small intestine, the cover is quickly dissolved (at rn 5.5), releasing enzymes with lipolytic, amylolytic and proteolytic activity that provides splitting of fats, carbohydrates and proteins. products of pancreatic digestion are soaked up after that or at once, or after further hydrolysis by intestinal enzymes.

Pharmacokinetics. Researches on animals did not reveal signs of absorption of enzymes in not changed look and therefore classical pharmacokinetic researches were not conducted. Additives of enzymes of a pancreas do not demand absorption for achievement of the effect. On the contrary, their full therapeutic action is shown in a GIT gleam. Moreover, as proteins they are exposed to proteolytic digestion, passing through a GIT before being absorbed in the form of peptides and amino acids.

corresponding acute, subchronic or chronic toxicity. Researches of genotoxicity, carcinogenicity or toxic impact on reproductibility were not conducted.

Indication

Insufficiency of exocrine function of a pancreas at adults and children caused various diseases, including stated below:

• mucoviscidosis;
• chronic pancreatitis;
• pancreatectomy;
• gastrectomy;
• pancreatic cancer;
• operation with an applying gastrointestinal anastomosis (for example gastroenterostomy according to Billroth of II);
• Shvakhman's syndrome — Diamonda;
• a state after an attack of acute pancreatitis and restoration of enteral or oral food.

Drug dosing is based by

on individual need of the patient and depends on extent of disturbance of digestion and structure of food. for selection of an adequate individual dose there are three doses of medicament — ermital 10,000, ermital 25,000, ermital 36,000. the medicament is recommended to be taken in time or right after food. of capsules and microtablets it is necessary to swallow entirely, without breaking and without chewing and to wash down with enough liquid or to use with light meal. if the capsule cannot be swallowed whole (children and elderly people), it can be opened and added a microtablet to the liquid food which is not demanding chewing, for example to apple puree, liquid with the neutral or subacidic environment (yogurt, grated apple). such mix should be accepted immediately and not to store.

during treatment by the medicaments Ermital 10,000, Ermital 25,000, Ermital 36,000 the use of enough liquid, especially during its increased loss is very important

. The deficiency of liquid can cause a constipation.

Dosing in a mucoviscidosis. Based on the recommendations of the Conciliatory conference on a mucoviscidosis, the researches "case control" of Association of a mucoviscidosis of the USA and the researches "case control" in Great Britain, it is possible to offer the following general recommendations for replacement therapy by pancreas enzymes.

Initial dose for children under 4 years makes 1000 PIECES of a lipase/kg of body weight during each meal and for children aged from 4 years — 500 PIECES of a lipase/kg of body weight during each meal.

Dose should be selected individually, depending on disease severity, control of a steatorrhea and maintenance of the appropriate nutritive status.

Maintenance dose for most of patients should not exceed 10,000 PIECES of lipases/kg/days or 4000 PIECES of a lipase on 1 g of the consumed fat.

Dosing at other types of exocrine insufficiency of a pancreas. The dose should be selected individually, depending on extent of disturbance of digestion and fat structure of food.

Initial dose makes from 10,000 to 25,000 PIECES of a lipase during each main meal. However it is possible that higher doses are necessary for some patients for elimination of a steatorrhea and maintenance of the appropriate nutritive status. According to the standard clinical practice it is considered that with food it is necessary to accept from at least 20,000 to 50,000 PIECES of a lipase. The dose for inclusion in time of the main meals (breakfast, a lunch or a dinner) can be from 25,000 to 80,000 PIECES of a lipase, and at additional easy food between the main meals has to make a half of an individual dose.

Contraindication

Hypersensitivity to active ingredient or any other component of drug.

Side effects

When studying influence of the medicaments containing Pancreatinum on patients it was most often reported about disturbances from a GIT, mainly easy and moderate severity.

further.

from a GIT: an abdominal pain (disturbances from a GIT were mainly connected with the existing disease), nausea, vomiting, a constipation, an abdominal distension, diarrhea, narrowing of ileocecal department of intestines and large intestine (fibroziruyushchy colonopathy).

from skin and hypodermic cellulose: rash, itching, urticaria.

from the immune system: hypersensitivity (anaphylactic reactions).

It was reported about narrowing of ileocecal department of intestines and large intestine (fibroziruyushchy colonopathy) at patients with a mucoviscidosis who accepted high doses of medicaments of Pancreatinum (see. Special INSTRUCTIONS).

Majority of the allergic reactions which are shown from skin and not only, are revealed as side reactions during postregistration use.

Children. Specific undesirable reactions at children it is not established. Type weight of undesirable reactions at the children sick with a mucoviscidosis, were similar to that at adults.

Special instructions

observed narrowing of ileocecal department of intestines and large intestine (fibroziruyushchy colonopathy) at patients with a mucoviscidosis who accepted high doses of medicaments of Pancreatinum.

as a measure of prevention it is recommended to address in case of unusual abdominal symptoms or change of nature of abdominal symptoms for medical consultation to exclude a possibility of a fibroziruyushchy colonopathy, especially if the patient accepts more than 10,000 PIECES of lipase/kg/days

As well as other medicaments of Pancreatinum of pork origin presented today at the market, Ermital 10,000, Ermital 25,000, Ermital 36,000 is made from tissues of a pancreas of the pigs intended for the food purposes. Though risk that with medicament the contagium will get into a human body it is reduced by tests and deactivation of certain viruses during production process, there is a theoretical risk of transfer of the viral infections including caused by new or uncertain viruses. Presence of pork viruses which can affect the person completely cannot be excluded.

However still did not register any case of transfer of an infectious disease owing to use of medicaments of pork Pancreatinum though they are applied already for a long time.

should use Drug with care at patients with a renal failure, a hyperuricemia, patients with an allergy to proteins of pork origin.

Use during pregnancy and feeding by a breast. Because there are no influences of enzymes of a pancreas on a pregnancy course given clinical trials, it is necessary to appoint medicament with care pregnant. Researches on animals showed lack of signs of absorption of enzymes of a pancreas. Thus, the possibility of toxic influence on a reproduction and fetation is not expected.

As researches on animals demonstrate lack of system exposure of enzymes of a pancreas at the woman during feeding by a breast, any impact on the child who is on breastfeeding is not predicted. Therefore there are no contraindications to use of enzymes of a pancreas during feeding by a breast.

If necessary pregnant women or women who nurse can take the medicament in the doses sufficient for ensuring the adequate status of food.

Children. Apply in pediatric practice.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Influence of medicament on ability to run vehicles or to work with other mechanisms is absent or is insignificant.

Research of interaction was not conducted by

Interaction

Overdose

It was reported about cases of a hyper uricosuria and a hyperuricemia which were connected with reception of Pancreatinum in very high doses.

Storage conditions

At a temperature not above 25 °C.