Panzinorm 10000

General characteristics. Structure:

Active ingredient: 123,9 mg of Pancreatinum powder (pork, in the form of pellets) 96,6, Evr corresponding to activity of a lipase of 10 000 Units. T., activities of amylase not less than 7 200 Units Evr. T., general proteolytic activity not less than 400 Units Evr. T.

Excipients: methacrylic acid and ethyl acrylate copolymer (1:1), dispersion of 30%, dry weight, triethyl citrate, talc, симетикон emulsion of 20%, dry weight.

Pellet cover: methacrylic acid and ethyl acrylate copolymer (1:1), dispersion of 30%, dry weight, triethyl citrate, talc, симетикон emulsion of 20%, dry weight.

Capsule lid: gelatin, titanium dioxide (E171), sodium lauryl sulfate. Capsule body: gelatin, titanium dioxide (E171), sodium lauryl sulfate.

The fermental drug used at digestive tract diseases including disturbance of functions of secretion of a pancreas.

Pharmacological properties:

Pharmacodynamics. Panzinorm 10 000 compensates insufficiency of vneshnesekretorny function of a pancreas. The combined drug which effect is caused by the components which are its part. High lipazny activity plays an important role in treatment of the maldigestiya caused by pancreatic fermental insufficiency. The lipase splits fats by hydrolysis on fatty acids and глицерол, thus, promotes their absorption and absorption of fat-soluble vitamins. Amylase splits carbohydrates on dextrins and sugar whereas protease splits proteins. Has a protective cover thanks to which active enzymes are released in a small intestine where pancreatic enzymes work. 

The enzymes which are a part of Pancreatinum the lipase, amylase and protease facilitate digestion of fats, carbohydrates and proteins that promotes their fuller absorption in a small intestine. Eliminates the symptoms arising owing to digestion disturbance (feeling of weight and overflow of a stomach, a meteorism, feeling of shortage of air, the asthma caused by accumulation of gases in intestines, diarrhea). Improves process of digestion of food at children; stimulates release of own enzymes of a pancreas, stomach and small intestine, and also bile.

Pharmacokinetics. Panzinorm 10 000 is issued in the form of the capsule in which pellets, film coated contain. The film cover of pellets protects active enzymes from influence of acid medium of a stomach that allows enzymes to be released in a small bowel. The most part of enzymes is inactivated, as a result of an autolysis and proteolysis. An insignificant part of digestive enzymes is allocated through intestines.

Indications to use:

• Compensates insufficiency of vneshnesekretorny function of a pancreas;

• Eliminates the symptoms arising owing to digestion disturbance (feeling of weight and overflow of a stomach, a meteorism, feeling of shortage of air, the asthma caused by accumulation of gases in intestines, diarrhea);

• Stimulates release of own enzymes of a pancreas, stomach and small intestine, and also bile.

Route of administration and doses:

Capsules are accepted inside, during food or light meal. Capsules should be accepted entirely, without chewing with enough liquid.

The dose and duration of therapy is defined individually   depending on age, degree of insufficiency of a pancreas and a diet.

The adult Panzinorm 10 000 recommend to accept (in the absence of other instructions) in an initiation of treatment the minimum doses: on 1-2 capsules 3 times a day, during each main meal (a breakfast, a lunch, a dinner). If necessary the single dose is gradually increased. Panzinorm's reception 10 000 is possible during reception of light meal.

It is necessary to accept the smallest effective doses, especially at patients with a mucoviscidosis.

At children drug is used on doctor's orders. To children is aged more senior than 3 years of-100 thousand. Piece/days (in terms of a lipase).

Duration of treatment can vary from a single dose or several days (at disturbance of process of digestion owing to errors in a diet) up to several months or years (in need of continuous replacement therapy).

Features of use:

Panzinorm 10 000 it is necessary to accept, without chewing, with enough liquid.

At a mucoviscidosis in case of exceeding of a necessary dose of Pancreatinum (more than 10 000 PIECES of Ph. Eur. lipases on 1 kg of body weight) development of strictures (a fibrous colonopathy) in ileocecal department and in the ascending colon is possible. Therefore at a mucoviscidosis the dose has to be adequate to amount of enzymes which is necessary for absorption of fats taking into account quality and amount of the consumed food.

If against the background of reception of capsules Panzinorm 10 000 there are symptoms of intestinal impassability, it is necessary to exclude a fibrous colonopathy.

Panzinorm's use 10 000 at pregnancy and in the period of a lactation (breastfeeding) is possible only if the expected positive effect of therapy surpasses possible risk, due to the lack of the clinical data confirming safety of use of enzymes of a pancreas for this category of patients.

It is not known of negative influence on ability of driving and work with other mechanisms.

Side effects:

Panzinorm 10 000 seldom causes undesirable effects.

Allergic reactions: hypersensitivity reactions, including dermahemia, skin rash, skin itch; obstruction of respiratory tracts.

From the alimentary system (at reception of high doses of drug): nausea, vomiting, abdominal pain (including intestinal colic), diarrhea, lock, perianal irritation, irritation of a mucous membrane of an oral cavity. At a mucoviscidosis in case of exceeding of a necessary dose of Pancreatinum (more than 10 000 PIECES of Ph. Eur. lipases on 1 kg of body weight) development of strictures (a fibrous colonopathy) in ileocecal department and in the ascending colon is seldom possible.

Others: hyperuricemia, hyper uricosuria, insufficiency of folates.

Interaction with other medicines:

At simultaneous prolonged use from Pancreatinum in high doses decrease in absorption of iron preparations (clinically not significantly) and folic acid is possible. It is recommended to control periodically the level of folates and/or purpose of folic acid.

At simultaneous use with Cimetidinum, bicarbonates it is also recommended to control periodically the level of folates and/or purpose of folic acid.

Pancreatinum can reduce efficiency of acarbose and a miglitol.

The cover of pellets, steady against acid, Panzinorm 10 000 is dissolved in a 12-perstny gut. At low PH value in a 12-perstny gut Pancreatinum is not released. Simultaneous use of blockers of H2-histamine receptors (Cimetidinum), hydrocarbonates, inhibitors of the protonew pump can lead to increase in efficiency of Pancreatinum that allows to lower Panzinorm's dose 10 000.

Contraindications:

Hypersensitivity to pork protein or other components of drug;

Acute pancreatitis, exacerbation of chronic pancreatitis;

Children up to 3 years (for this dosage form) and the children up to 15 years suffering from a mucoviscidosis.

Overdose:

The overdose by drug Panzinorm 10 000 does not cause system intoxication.

Symptoms: nausea, vomiting, diarrhea, hyper uricosuria, hyperuricemia, perianal irritation; seldom the fibrous colonopathy (develops at a mucoviscidosis).

Treatment: drug withdrawal, hydration, symptomatic therapy.

Storage conditions:

List B. To store at a temperature not above 30 °C. To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

Capsules: on 7 capsules in the blister. On 3, 8 or 12 blisters in a pack cardboard together with the application instruction