The instruction for medical use of Креон® 25000 medicine the Trade name Креон® 25000 International unlicensed name Are not present the Dosage form of the Capsule, the containing minimicrospheres covered with a kishechnorastvorimy cover, 300 mg Structure One capsule contains active agent – Pancreatinum of 300 mg, with the minimum enzymatic activity: amylases – 18000 Pieces Evr. F., lipases – 25000 Pieces Evr. F., proteases – 1000 Pieces Evr. F., made from tissue of a pancreas of pork origin, excipients a kernel of pellets: macrogoal 4000, cover of pellets: gipromelloza phthalate, cetyl alcohol, triethyl citrate, dimetikon 1000, capsule cover: gelatin, ferrous oxide anhydrous III (E 172), the ferrous oxide hydrated by III (E 172), the titan dioxide (E 171), sodium lauryl sulfate. The description Solid, gelatin capsules, No. in size 0, with a red-brown lid and the colourless body, the Drugs filled with brown minimicrospheres (pellets) Pharmacotherapeutic group, digestant (including fermental drugs). Digestive fermental drugs. Pancreatinum the ATX A09AA02 Code the Pharmacological Pharmacokinetics It Is Known properties that intact enzymes are not soaked up therefore classical researches on pharmacokinetics Креон® 25000 were not conducted. Implementation of effect of pancreatic enzymes does not require their absorption. On the contrary, full therapeutic action is carried out in a digestive tract gleam. As they represent proteinaceous molecules, enzymes are exposed further to proteolytic digestion in process of advance on digestive tract, are not absorbed in the form of peptides or amino acids yet. A pharmacodynamics Креон® 25000 capsules contain Pancreatinum of pork origin in the form of the minimicrospheres covered with a kishechnorastvorimy (acid resisting) cover. The cover of capsules is quickly dissolved in a stomach, releasing hundreds of minimicrospheres. At the same time minimicrospheres mix up with a chyme already in a stomach that considerably increases the area of contact of a food lump and pancreatic enzymes. When minimicrospheres reach a small intestine, their kishechnorastvorimy cover quickly collapses (at rn & gt, 5.5) with the subsequent release of enzymes with lipolytic, amylolytic and proteolytic activity that as a result leads to disintegration of molecules of fats, starches and proteins. Then products of pancreatic digestion are exposed to absorption or the subsequent hydrolysis by intestinal enzymes. Results of clinical trials of All 23 clinical trials of efficiency of Kreona® at patients with exocrine insufficiency of a pancreas were conducted. At the same time 7 of them were placebos – controlled or the researches estimating efficiency of treatment of rather initial state with participation of patients with a mucoviscidosis, chronic pancreatitis or after surgical interventions. In all randomized placebos – controlled researches advantage of Kreona® before placebo in primary parameter of efficiency, that is the fat absorbtion coefficient (FAC) was primary final point. In all researches, regardless of a disease etiology, considerable improvement of specific symptoms (such as frequency and consistence of a chair, meteorism and abdominal pain) was shown. Children In a mucoviscidosis the efficiency of Kreona® was shown in three placebos – the controlled researches conducted with participation of children and teenagers with a mucoviscidosis and also in one controlled on an initial state to a research with participation of babies. In total 118 patients participated in these researches. The KPZh loudspeaker shows that there are no differences in efficiency of Kreona® caused by age of patients. Indications With the replaceable purpose at exocrine insufficiency of a pancreas – a mucoviscidosis – chronic pancreatitis – a state after pancreatectomy – a pancreatic cancer – a state after a full or partial resection of a stomach (a gastroenterostom) – obstruction of pancreat ducts or the general bile duct (including, owing to a new growth) – Shvakhmana-Diamond’s syndrome – acute pancreatitis during restoration of an enteroalimentation select the Route of administration and doses of the Dose of drug for Billroth-II individually depending on disease severity and structure of a diet. ÈÓÑ«¡® 25000 capsules accept inside during meal. In need of reception more than 1 Креон® 25000 1 capsule the capsule is accepted to, by the others – during meal. Capsules should be swallowed entirely, without breaking them and without chewing, washing down with enough liquid. At the complicated swallowing (for example, at small children or patients of senile age) capsules carefully open, and minimicrospheres add to the soft food which is not demanding chewing (for example, to apple puree), or accept with liquid. At the same time food or liquid with which mix minimicrospheres have to be acid (fruit juice or yogurt) that there was no premature release and destruction of enzymes (pH<, 5.5). Chewing or damage of minimicrospheres can break a protective kishechnorastvorimy cover therefore premature release of enzymes can cause irritation of a mucous oral cavity and/or reduce therapeutic effect of drug. Any mix of minimicrospheres with food or with liquid is not subject to storage and it should be accepted at once after preparation. It is important to accept constantly enough liquid, especially at the strengthened its loss. Insufficient intake of liquid can become the cause of a constipation. If the patient forgot to accept Креон® 25000 in time, it is possible to accept the passed dose directly after meal. Later reception is not reasonable. During the following meal it is necessary to accept a usual dose of drug. It is not necessary to accept a double dose for compensation of the passed dose. The mucoviscidosis In a mucoviscidosis a dosage of drug is selected by the attending physician. According to the recommendations of the American Fund of the Mucoviscidosis, the dose Креон® 25000 is expected in number of lipase units 1 kg of body weight on one meal. Depending on age the single dose is calculated as follows: The age of the child of the Recommendation Up to 4 years of 1000 units of a lipase on 1 kg of body weight Is more senior than 4 years of 500 units of a lipase on 1 kg of body weight the Dosage and duration of treatment define depending on disease severity, results of control of a steatorrhea and maintenance of the good status of food. At most of patients the dose should not exceed 10000 units of a lipase/kg of body weight a day or 4000 units of a lipase on 1 gram of fat in food. For optimum individual dosing except Креон® 25000, there is a dosage with lower content of enzymes. As it is difficult to divide contents of the Креон® 25000 capsule into several receptions, treatment is recommended to begin at children with body weight not less than 25 kg. For use for children weighing less than 25 kg the dosage with lower content of enzymes (Креон® 10000) is recommended. A dosage at other states which are followed by exocrine insufficiency of a pancreas. The dosage and duration of treatment should be established taking into account specific features of the patient to which extent of disturbance of digestion and content of fat in food belongs. The dose which is required to the patient together with the main meals (a lunch, a breakfast or a dinner) can vary from 25000 to 80000 Units of a lipase (Evr. F.) that makes from 1 to 3 Креон® 25000 capsules, and during intake of light meal between the main meals the dose makes about a half of an individual dosage, or 1/2-2 capsules. Side effects Very often – an abdominal pain * it is frequent – nausea, vomiting, a meteorism, diarrhea, a constipation Infrequently – rash Frequency is unknown – a fibroziruyushchy colonopathy, reactions of hypersensitivity (anaphylactic reactions), skin allergic reactions: urticaria, 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 In clinical trials with participation of patients of children’s age additional side reactions are not revealed. The contraindication – the increased individual sensitivity to Pancreatinum of pork origin or any other component of drug Medicinal interactions of Messages about interaction with other medicines or about other forms of interaction does not exist. At a concomitant use the absorption of folic acid decreases that demands increase in a dose of the last and also reduction of effect of drugs of acarbose and a miglitol. Special indications of the Stricture of an ileocecal corner and a large intestine (fibroziruyushchy colonopathy) are described at the patients with a mucoviscidosis accepting high doses of Pancreatinum. As a precautionary measure it is recommended to subject all unusual symptoms or changes from digestive tract to careful medical assessment for the purpose of an exception of damage of a large intestine. Especially in case the patient accepts more than 10000 units of a lipase/kg of body weight a day. As well as other drugs containing Pancreatinums Креон® 25000 are produced from tissue of a pancreas of the pigs who are specially grown up for consumption. Though the risk of transfer of infectious agents to the person Креоном® 25000 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 the new or not identified viruses. Presence of pork viruses which could infect the person cannot be excluded completely. However currently there are no messages about transfer of the infectious diseases connected with use of pork Pancreatinum whereas this substance is used throughout a long span. Pregnancy and the period of a lactation Креон® 25000 during pregnancy are appointed with care. In view of lack of system absorption of pancreatic enzymes, during breastfeeding appoint Креон® 25000 in the doses necessary for ensuring the sufficient status of food. The feature of influence of medicine on ability to run the vehicle or potentially dangerous Креон® 25000 mechanisms does not affect ability to driving of the car and control of cars and mechanisms. Overdose Symptoms: the doses Креон® 25000 much exceeding therapeutic can cause a hyper uricosuria and a hyperuricemia. Treatment: the drug withdrawal, sufficient consumption of liquid supporting actions. A form of release and packing On 20, 50, 100 capsules in the bottles from polyethylene of high density of white color corked by the twisting cover with the opening control unit. On bottles paste labels from paper self-adhesive. Each bottle together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard bandbox. To Store storage conditions at a temperature not higher than 25 wasps in densely closed packing. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Not to apply after 3 months after opening of a bottle. Prescription status Without prescription the Name and the country of the Abbott Laboratories GmbH manufacturing organization, Germany. 31535, Noyshtadt am Ryubenberg, Justus-von Libich Strase, 33. The name and the country of the owner of the registration certificate of Abbott Laboratories GmbH, Germany the Name and the country of the Abbott Laboratories GmbH organization packer, Germany the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products: Representative office “Abbott Laboratories S.A.” in Republic of Kazakhstan, Dostyk Ave. 117/6, Business center “Khan Tengri-2”, 050059, Almaty, Republic of Kazakhstan. Ph.: +77272447544, fax: +77272447644. e-mail:
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