CREON 25000 Multienzymes capsules 300mg №20

CREON 25000 Multienzymes capsules 300mg №20

Product Code: 8061
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Composition

active substance:

Kreon10000: 1 capsule contains 150 mg Pancreatin in gastroresistant granules (microspheres ), which have enzyme activity of: lipase 10000 units EPH, EPH amylase 8000 units, protease 600 units. EPH;

Kreon25000: 1 capsule contains 300 mg Pancreatin in gastroresistant granules (microspheres ), which have enzyme activity of: lipase 25000 units EPH, EPH amylase 18000 units, protease 1000 units EPH;

Kreon40000: 1 capsule contains 400 mg of Pancreatin in gastroresistant granules (microspheres ) that have enzymatic activity: 40000 units EPH lipase, amylase 25000 units EPH, protease 1600 units. EPH;

Excipients:macrogol 4000, hypromellose phthalate, cetyl alcohol, triethyl citrate, dimethicon 1000,

capsule solid:gelatin, iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate. 

The

Dosage form

Capsules hard with gastroresistant granules.

basic physico-chemical properties:

CREON10000-two-colour solid gelatin capsules of size 2 with a brown opaque lid and a colourless transparent body filled with brownish granules (minimicrospheres)

Kreon25000 two - color hard gelatin capsules of size 0 with orange opaque cap and colourless transparent body filled with brownish granules (minimicrospheres )

CREON40,000 - two-tone solid gelatin capsules of size 00 with a brown opaque lid and a colorless transparent body filled with brownish granules (minimicrospheres ).

The

drug description

Medications improving digestion, including enzymes. Multienzyme preparations. Code ATH A09A A02.

The

Pharmacological properties

Pharmacodynamics.

Kreoncontains Pancreatin porcine origin in the form of a coated enteric-soluble shell (resistant to acidic environment) minimicrospheres in gelatin capsules. The capsules dissolve quickly in the stomach, releasing a large amount of minimicrosfer for a multi-dose principle, which provides good mixing with the contents of the stomach, transport from the stomach along with its contents and after releasing a good distribution of enzymes in the contents of the intestine. When minimicrospheres enter the small intestine, the membrane dissolves quickly (with pH> 5.5), releasing enzymes with lipolytic, amylolytic and proteolytic activity, provides the splitting of fats, carbohydrates and proteins. The products of pancreatic digestion is then absorbed immediately or after further hydrolysis by intestinal enzymes.

Clinical efficacy.

a total of 30 studies were conducted on the efficacy of CREONin patients with exocrine pancreatic insufficiency (EPP). Ten of them were either placebo-controlled or compared with baseline data; patients with cystic fibrosis, chronic pancreatitis, or postoperative conditions participated in these studies.

in all randomized placebo-controlled studies of the effectiveness of a predetermined primary goal was to increase the efficiency of the drug CREONcompared with placebo in the primary indicator of effectiveness - fat absorption coefficient (CVZH).

fat absorption Factor determines the fat content that is absorbed into the body, taking into account the consumption of fat and the elimination of fat with feces. In placebo-controlled studies of EPP, the mean EHW (%) was higher in patients taking CREON(83%) compared with the placebo group (62.6%). In all studies, regardless of design, the average value KVZH (%) at the end of the treatment period CREONwas similar to the average values KVZH for drug CREON, were used in the placebo-controlled studies.

during all the studies, regardless of the etiology of the disease, there was also an improvement in the characteristic symptoms (frequency of the chair, their consistency, flatulence).

Children.

the Efficacy of CREONhas been demonstrated in 288 children from newborn to adolescence with cystic fibrosis. In all studies, mean values of EHF at the end of CREON treatmentexceeded 80% in children of all age groups.

Pharmacokinetics.

animal Studies have revealed no signs of absorption of the enzymes in an unmodified form, and therefore classical pharmacokinetic studies have not been conducted. Supplements of pancreatic enzymes do not require suction to achieve its effect. On the contrary, their full therapeutic effect is manifested in the lumen of the gastrointestinal tract. Moreover, as proteins they undergo proteolytic digestion, passing through the gastrointestinal tract, before being absorbed in the form of peptides and amino acids.

data from preclinical studies do not indicate any relevant acute, sub-chronic or chronic toxicity. There were no studies of genotoxicity, Carcinogenicity or toxic effects on reproduction.

Reading

treatment of exocrine pancreatic insufficiency in adults and children caused by various diseases, including those listed below, but not limited to:

The
    The
  • cystic fibrosis
  • The
  • chronic pancreatitis
  • The
  • pancreatectomy;
  • The
  • gastrectomy;
  • The
  • surgery with imposing gastrointestinal anastomosis (eg resection of stomach by Billroth II);
  • The
  • syndrome of Shwachman-diamond;
  • The
  • after the attack of acute pancreatitis and recover oral or enteral nutrition.

Contra

Hypersensitivity to the active substance or to any other component of the drug.

The

Interaction with other medicinal products and other forms of interaction

the Study of the interaction have not been conducted.

application Features

in patients with cystic fibrosis, who took high doses of Pancreatin, there were narrowing of the ileocecal intestine and colon (fibrous colonopathy).

as a preventive measure, it is recommended to seek medical advice in case of unusual abdominal symptoms or changes in the nature of abdominal symptoms in order to exclude the possibility of fibrous colonopathy, especially if the patient takes more than 10,000 units of lipase/kg/day.

Like other on the market today drugs Pancreatin of porcine origin, Kreonis made from the pancreatic tissue of pigs intended for food purposes. Although the risk that CREON drugin the human body will be the infectious agent is reduced by testing, and deactivation of certain viruses during the manufacturing process, there is a theoretical risk of transmission of viral infections, including those caused by new or uncertain viruses. The presence of swine viruses that can affect a person can not be completely excluded.

however, no cases of transmission of infectious disease due to the use of porcine Pancreatin have been reported so far, although they have been used for a long time.

the Drug should be used with caution in patients with renal insufficiency, hyperuricemia, patients with Allergy to proteins of porcine origin.

use during pregnancy or lactation.

due To the fact that there are no data from clinical studies of the effect of pancreatic enzymes on the course of pregnancy, the drug should be used with caution in pregnant women. Studies on animals showed no signs of absorption of pancreatic enzymes. Thus, the possibility of toxic effects on reproduction and development of the fetus is not expected.

Because animal studies show the lack of systemic exposure of pancreatic enzymes in lactating, any influence on the child, breastfeeding, is not expected. Therefore, pancreatic enzymes can be used in women during breastfeeding.

If necessary, pregnant women or women who are breastfeeding, can you take CREONin doses sufficient to provide adequate nutritional status.

Ability to influence the reaction rate when driving motor transport or operating other mechanisms.

the Effect of CREONon the ability to drive vehicles or operate other machinery is absent or negligible.

Method of application and doses

the Dosage of the drug is based on the individual needs of the patient and depends on the severity of the disease and the composition of the food.

the Drug should be taken during or immediately after a meal.

Capsules and mini granules should be swallowed as a whole, without breaking or chewing, with enough liquid during or after meals, Including snacks. If the patient can not swallow the whole capsule (for example, children and elderly patients), it can be carefully opened and add mini granules to the soft food with acidic medium (pH <5.5), does not require chewing, or to the liquid with acidic medium (pH <5.5).

it can be Apple puree or yogurt, or fruit juice with pH <5.5, such as Apple, orange or pineapple juice. This mixture should not be stored. Cleavage and chewing minimicrospheres granules or adding them to food or liquid with pH> 5.5 can destroy their protective intestinal lining. This can lead to the premature release of enzymes in the oral cavity, as well as to a decrease in the effectiveness of the drug and irritation of the mucous membranes.

it is necessary to control that the drug does not remain in the oral cavity.

During treatment with CREON10000, CREON25000, CREON40,000 it is very important to consume enough fluid, especially during the period of increased loss. Lack of fluid can increase constipation. Minimicrospheres any mixture of granules with food or liquids should be taken immediately and not stored.

Dosing for cystic fibrosis.

Based on the recommendations of the conciliation conference on cystic fibrosis (MV), the case-control studies of the mV Association and the case-control studies in the UK, the following General dosing recommendations for substitution therapy with pancreatic enzymes can be proposed

The
  • the starting dose for children under 4 years of age is 1000 lipases per kilogram of body weight for each meal and for children under 4 years of age-500 lipases per kilogram of body weight for each meal;
  • the dose should be selected individually, depending on the severity of the disease, control steatorrhea and maintain proper nutritional status;
  • The
  • maintenance dose for most patients should not exceed 10,000 units of lipase per kilogram of body weight per day or 4000 units of lipase per gram of fat consumed.

Dosing for other types of exocrine pancreatic insufficiency

The
  • the dose should be selected individually, depending on the degree of digestive disorders and fat composition of the food. When eating, you need doses of 25,000 to 80,000 units. EF lipase and half of the individual dose with a light snack.
The

Children

CREONcan be used for children.

Overdose

cases of hyperuricosuria and hyperuricemia have been Reported to have been associated with extremely high doses of Pancreatin. 

Side effects

in clinical trials, the effect of CREONhas been studied in more than 900 patients. This files most often reported gastro-intestinal tract, mainly light and medium severity.

Adverse reactions that have been observed during clinical trials and their frequency presented below.

from the gastrointestinal tract:very often (? 1/10)-abdominal pain *; often (? 1/100 to <1/10) - nausea, vomiting, constipation, bloating, diarrhea *, unknown frequency - narrowing of the ileocecal part of the intestine and large intestine (fibrosis colonopathy).

disorders of the gastrointestinal tract was mainly related to an existing disease. About diarrhea and abdominal pain was reported with a frequency similar to or less than when using a placebo.

on the part of the skin and subcutaneous tissue:uncommon (? 1/1, 000 to<1/100) - rash, unknown frequency - itching, hives.

from the immune system: unknown frequency - hypersensitivity (anaphylactic reactions).

it was Reported about the narrowing of the ileocecal intestine and colon (fibrosarcoma kolonopatii) in patients with cystic fibrosis who took high doses of Pancreatin (see Section "Peculiarities of use").

most allergic reactions that occur from the skin, but not only, have been detected as adverse reactions during the post-registration application. Since reports of these reactions were spontaneous and received from an indefinite number of patients, it is not possible to estimate the exact frequency of these reactions.

children

the Specific adverse reactions in children is not established. The frequency, type and severity of adverse reactions in children with cystic fibrosis were similar in adults.

The

shelf Life

3 years. Shelf life after the first opening - 6 months.

storage Conditions

Store at a temperature not exceeding 25° C in a tightly closed container. Keep out of reach of children.

The

Packaging

At 20, 50, 100 capsules in bottles of high density polyethylene, 1 bottle in a cardboard box.

CREON25000, CREON40,000:10 capsules per blister, 2 blisters per carton.

CREON10000:10 capsules each in a blister, 1 or 2 or 3 blisters each in a carton.

The

Category vacation

over the counter.

The

Manufacturer

Abbott laboratories GmbH/Abbott Laboratories GmbH.

location of the manufacturer and address of the place of business

Abbott laboratoriz, plant Neustadt, Justus-von-Liebig-str. 33, 31535 Neustadt A. Rbge., Germany/Abbott Laboratories, Plant Neustadt, Justus-von-Liebig-Str. 33, 31535 Neustadt a. Rbge., Germany.

& nbsp;

CAPSULES CREON 25000 300MG

enteric coated Medicinal remedy CREON 25000 is a gelatin hard capsule with a colorless transparent body and opaque orange cap. Comes in a tight plastic vials of 20 units each. One capsule contains 300 mg of Pancreatin, an active ingredient in the drug. Refers to the means from the group of multienzyme preparations improves digestion. Assigned in these States:

    The
  • Pancreatitis in the chronic form.
  • The
  • Removal of the stomach or pancreas.
  • Cystic fibrosis. The

  • Patients with the syndrome of Shwachman-diamond.

How to use & nbsp;

this medicine is recommended to be used orally in the process of eating or immediately after eating. Before the start of the reception requires a doctor's consultation, which will calculate the dose and duration of treatment (they may vary depending on the results achieved).

Contraindications to use

there are a number of conditions in which the drug can not be used: individual intolerance to the components of the drug, renal failure. With caution assigned to children, elderly patients.

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