The instruction for medical use of Креон® 10000 medicine the Trade name Креон® 10000 International unlicensed name Are not present the Dosage form of the Capsule, the containing minimicrospheres covered with a kishechnorastvorimy cover, 150 mg Structure One capsule contains active agent – Pancreatinum of 150 mg, with the minimum enzymatic activity: amylases – 8000 Pieces Evr. F., lipases – 10000 Pieces Evr. F., proteases – 600 Pieces Evr. F., excipients kernel of pellets: macrogoal 4000, cover of pellets: cetyl alcohol, gipromelloza phthalate, triethyl citrate, dimetikon 1000, capsule cover: gelatin, gland (III) oxide anhydrous (E 172), gland (III) oxide hydrated (E 172), gland (II, III) oxide (E 172), the titan dioxide (E 171), sodium lauryl sulfate. The description Solid, gelatin capsules, No. in size 2, with a dark brown lid and the colourless body, the Digestive tract and a metabolism filled with brown minimicrospheres (pellets) Pharmacotherapeutic group. Drugs, 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® 10000 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® 10000 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 30 clinical trials of efficiency of Kreon at patients with exocrine insufficiency of a pancreas were conducted. At the same time 10 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 Kreon’s advantage before placebo in primary parameter of efficiency – to the fat absorbtion coefficient (FAC) was primary final point. KPZh is calculated in the form of the percentage of amount of the absorbed fat to amount of the fat removed from an organism with excrements. In placebo – controlled researches with participation of patients with the exocrine insufficiency of a pancreas (EIP) the KPZh average value (%) at treatment by Kreon was above (83.0%), than at intake of placebo (62.6%). In other researches, irrespective of design, the KPZh average value at the end of treatment by Kreon was the same, as well as in placebo – controlled researches. In all researches, regardless of a disease etiology, improvement of specific symptoms (frequency and consistence of a chair, a meteorism) was shown. Children the Efficiency of the drug Kreon® at patients with a mucoviscidosis was shown at patients aged from newborns to teenagers. In all researches the average value of KVZh at children by the end of the Kreon® drug treatment exceeded 80% regardless of age. Indications the Broken exocrine function of a pancreas connected with digestion disturbance. Support of insufficient function of a pancreas for a mucoviscidosis. The route of administration and doses of the Dose of drug select individually depending on disease severity and structure of a diet. ÈÓÑ«¡® 10000 capsules accept inside during meal or right after it. In need of reception more than 1 Креон® 10000 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 children or patients of senile age) capsules carefully open, and minimicrospheres add to the soft food which is not demanding chewing or accept with drink. At the same time food or drink with which mix minimicrospheres have to be with acid taste that there was no premature release and destruction of enzymes (pH & lt, 5.5). It can be apple puree, yogurt or fruit juice, for example, pineapple, apple or orange. Any mix of minimicrospheres with food or with liquid is not subject to storage and it should be accepted at once after preparation. 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. It is also necessary to watch that minimicrospheres did not remain in an oral cavity after meal. 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 Kreon® in time, it is possible to accept the passed dose directly after meal. Much 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 choice of a dose for children and adults in a mucoviscidosis In a mucoviscidosis a dosage of drug is chosen by the attending physician. According to the recommendations of the American Fund of the Mucoviscidosis, the dose of the drug Kreon® is calculated as follows: – Dosing has to be based on body weight and be calculated in number of 1000 units of a lipase on 1 kg of body weight on one meal for children under 4 years and in number of 500 units of a lipase on 1 kg of body weight on one reception for age category 4 years are more senior. 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 are defined 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 10,000 units of a lipase/kg of body weight a day or 4000 units of a lipase on 1 gram of fat in food. 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 3 to 8 Креон® 10000 capsules, and during intake of light meal between the main meals the dose makes about a half of an individual dosage, or 1-4 capsules. Side effects Very often – an abdominal pain * it is frequent – nausea, vomiting, a meteorism, diarrhea, a constipation * Infrequently – rash Frequency is unknown – reactions of hypersensitivity (anaphylactic reactions), skin allergic reactions: urticaria, an itching, a fibroziruyushchy colonopathy ** * 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. 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. 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. Pregnancy and the period of a lactation Креон® 10000 during pregnancy are appointed with care. In view of lack of system absorption of pancreatic enzymes, during breastfeeding appoint Креон® 10000 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® 10000 mechanisms does not affect ability to driving of the car and control of cars and mechanisms. Overdose Symptoms: the doses Креон® 10000 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. Alternative packing. On 10 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 1 or 2 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard bandbox. To Store storage conditions at a temperature not above 25 °C 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 6 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. Name and country of the owner of the registration certificate of Abbott Laboratories GmbH, Hanover, Germany Name and country of the Abbott Laboratories GmbH organization packer, Germany 31535, Noyshtadt am Ryubenberg, Justus-von Libich Strase, 33. The name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety medicinal means: Abbott Kazakhstan LLP 050059 Almaty, Dostyk Ave., 117/6, BC Han Tengri – 2 ph.: +7 727 2447544, fax: +7 727 2447644 e-mail:
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