Pangrol 10,000 IU capsule contains 20s. minitablets coated sol. / intestinal.

The instruction for medical use of Пангрол®10,000 medicine the Trade name Пангрол®10,000 International unlicensed name Are not present the Dosage form of the Capsule, active agent contains the containing minitablets covered with a kishechnorastvorimy cover 10000ED Structure One capsule: Pancreatinum (pancreas powder) 153.5 ¹ (98.3 - 178.6) mg (lipases: 10,000 PIECES, amylases: not less than 9,000 PIECES of protease: not less than 500 PIECES) excipients: sodium of a kroskarmelloz, cellulose microcrystalline, the castor oil hydrogenated of silicon dioxide colloidal anhydrous, magnesium stearate, copolymer methacrylic acid - % ethyl acrylate (1:1) 30 dispersion, talc, trietit citrate, a simetikon of 30% an emulsion (dry) cover of the capsule: ferrous oxide red (E172), ferrous oxide yellow (E172), indigo carmine (E 132), quinolinic yellow (E 104), titan dioxide (E 171), gelatin. 1 - There corresponds to the stated maintenance of at least 10,000 EF of units of lipolytic activity, including 30% the surplus for stability the Description Solid gelatin capsules of 2 in size, with the opaque body of light orange color and an opaque lid of yellowish-green color. Contents of capsules - homogeneous brilliant mini-tablets of light brown color. Pharmacotherapeutic group Drugs, digestant (including fermental drugs). Digestive fermental drugs. Pancreatinum. The ATX A09AA02 code the Pharmacological Pharmacokinetics Powder properties from pancreases is not acquired in digestive tract, and output with a stake, its most part collapses or denatured by gastric juice or bakterialno. Bioavailability of the Mini-tablet are released in a stomach from self-soluble capsules and are evenly distributed in food weight. The Kishechnorastvorimy cover of mini-tablets protects enzymes, sensitive to acid, from deactivation by gastric juice during passing through a stomach. Enzymes begin to be released after achievement of the neutral or weak-basic environment of a small intestine and after dissolution of a covering. As powder from pancreases is not soaked up, it is impossible to provide data on its pharmacokinetics and bioavailability. The efficiency of powder from pancreases is determined by degree and speed with which enzymes are released from a dosage form and, thus, corresponds to pharmaceutical availability. The pharmacodynamics Пангрол® 10,000 contains Pancreatinum. Pancreatinum is a powder from pancreases of pigs which along with the emitted pancreatic enzymes a lipase, alpha amylase, trypsin and chymotrypsin contains other enzymes. Pancreatinum also contains other accompanying substances not having enzymatic activity. The digestive efficiency is determined by activity of enzymes and also in a galenichesky form. The enzymatic activity of a lipase and content of trypsin whereas the amylolytic activity matters only for treatment of cystous fibrosis as splitting of the polysaccharides which are contained in food is not affected even in chronic pancreatitis are decisive. The pancreatic lipase splits fatty acids of a molecule of a triatsilglitserid in provisions 1 and 3. Thus, free fatty acids are formed, and 2 monoglycerides are quickly acquired mainly in an upper part of a small intestine by means of bile acids. The pancreatic lipase of animals, like a lipase of the person, easily decays acid, it means that lipolytic activity it is irreversible is inactivated at pH lower than 4. For this reason of Pangrol®10000 is issued in a kishechnorastvorimy dosage form. Trypsin is activated from trypsinogen of an avtokatalicheska or enterokinase of a small intestine, and causes activation of other proteolytic enzymes. As well as an endopeptidase, it splits peptide bonds in which the lysine and arginine are involved and, thus, provides proteolysis in amino acids and small peptides along with other enzymes due to splitting of peptide bonds. On the basis of recently conducted researches, for trypsin the inhibition as feedback of stimulated secretion of a pancreas active trypsin in an upper part of a small intestine is supposed. The soothing effect of drugs of a pancreas described in some researches is attributed to this effect. Alpha amylase, as well as endoamylase, very quickly splits the polysaccharides containing glucose therefore its activity is usually enough, even at significant deterioration in secretory activity of a pancreas, connected with a disease. Indications For treatment of exocrine insufficiency of a pancreas the Route of administration and doses the Purpose of Пангрол® 10000 drug treatment is achievement or maintenance of normal body weight and normalization of frequency of defekation or consistence a calla. The dose is defined according to weight of the available insufficiency of function of a pancreas. Usually recommended dose is the lipase dose 20000 - 40000 Ph. Eur. units on meal. Therefore if other is not appointed, the dose makes 2 - 4 Пангрола® 10,000 capsules on meal (20000 - 40000 Ph is equivalent. Eur. lipase units on meal). The required dose can be above stated. It is necessary to increase a dose only after consultation with the doctor and for the purpose of improvement of symptoms (for example, at a steatorrhea, a stomach ache). It is not necessary to exceed a daily dose of enzymes of 15,000 - 20,000 units of a lipase on kilogram of body weight. It is not necessary to exceed the dose of enzymes necessary for sufficient absorption of fats, taking into account quantity and structure of food, especially at patients with a mucoviscidosis. Пангрол® 10,000 it is necessary to swallow entirely, washing down with enough liquid, in the middle of meal. For reception simplification solid capsules it is also possible to open and swallow only their contents, washing down with a small amount of liquid. At reception you watch swallowing Пангрол® 10,000 entirely as its efficiency can decrease when chewing, and the enzymes which are contained in it at release in an oral cavity can lead to injury of a mucous membrane of a mouth. Duration of use Пангрола® 10,000 depends on course of a disease and is defined by the doctor. Side effects Very often - an abdominal pain * Often nausea, vomiting, a meteorism, diarrhea, a constipation * Infrequently rash Very seldom:  1/10,000 - hypersensitivity of a stomach and intestines, discomfort and an abdominal pain - allergic reactions of immediate type (such as skin rash, small tortoiseshell, sneezing, dacryagogue, otdyshka and bronchospasm). - formation of strictures in ileocecal area and in the ascending gut at patients with a mucoviscidosis were described after reception of high doses of powder from pancreases (a fibroziruyushchy colonopathy **) It is unknown: it is impossible to estimate on the basis of available data At patients with a mucoviscidosis, especially at reception of high doses of powder from pancreases, perhaps strengthened removal of uric acid with urine. Therefore at such patients the removal of uric acid with urine is necessary to avoid formation of urate stones. An itching * Gastrointestinal disorders are connected with a basic disease. Frequency of an abdominal pain and diarrhea is similar or below, than in the group accepting placebo. ** The Fibroziruyushchy colonopathy is described at the patients with a mucoviscidosis accepting high doses of the drugs containing Pancreatinum (see. Special instructions). In clinical trials with participation of patients of children's age additional side reactions are not revealed. Contraindications - hypersensitivity to Pancreatinum of pork origin, to pork (allergy to pork) or on any excipient of drug Пангрол® 10,000 - acute pancreatitis and bad attacks of chronic pancreatitis are in full swing diseases. However in a phase of recession of a disease during expansion of a diet the periodic administration of drug is reasonable if signs of deterioration in function of a pancreas are resistant - children's age up to 18 years Medicinal interactions At reception of the finished pharmaceutical products containing powder from pancreases the reduction of absorption of folic acid is possible therefore additional intake of folic acid can be required. At the accompanying reception with drug Пангрол® 10,000 the effect of acarbose and a miglitol - antidiabetic means for intake can decrease. Special instructions At the patients with a mucoviscidosis accepting high doses of Pancreatinum are described strictures of the ileocecal gate and a large intestine (fibroziruyushchy colonopathy). For caution of any unusual symptoms or changes in abdominal area the medical control is necessary for patients who take the drug in a dose of more than 10000 PIECES of a lipase on body weight kg a day for an exception of a fibroziruyushchy colonopathy, especially. Пангрол® 10,000 contains active enzymes which at release in an oral cavity, for example, when chewing, can lead to injury of a mucous membrane of a mouth (ulcerations). Therefore at reception you watch swallowing Пангрол® 10,000 entirely. Пангрол® 10000 pregnant women have no pregnancy and the period of a lactation of Sufficient data on use. Concerning impact on pregnancy, development of an embryo/fruit, childbirth or post-natal development of the data obtained in experiments on animals it is not enough. Therefore the potential risk for the person is unknown. In this regard at pregnancy and a lactation the reception Пангрол®10,000 is not recommended unless it is absolutely necessary. Features of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms Special precautionary measures are not required. Overdose Symptoms: significantly the exceeding therapeutic can lead doses to increase in concentration of uric acid in blood serum and in urine. Treatment: the drug withdrawal, sufficient consumption of liquid supporting actions. The form of release and packing On 20, 50 capsules place in a polypropylene bottle with the polyethylene cover containing dehumidifier - polypropylene capsules with silica gel. On 1 bottle together with the instruction for medical use in the state and Russian languages put in a cardboard pack. To Store storage conditions at a temperature not above 25ºC. To store out of children's reach! A period of storage In the sealed packings: 2 years the use Period after opening of a bottle no more than 6 months. Not to apply after expiry date. Prescription status Without prescription the Owner of the registration certificate of Menarini International Opereyshnz the Village of Luxembourg. And., Luxembourg Producer: Berlin-Hemi AG (Menarini Group) Gliniker Weg 125 12489 Berlin, Germany of Organization-upakovshchik Advans Pharm GmbH, Germany it Is made on
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