Creon 10000 20 pcs. enteric capsules abbott laboratories gmbh/

Nosological classification (ICD-10)

• C25 Malignant neoplasm of the pancreas
• E84.1 Cystic fibrosis with intestinal manifestations
• K31.5 Duodenal obstruction
• K31.8 Other specified diseases of the stomach and duodenum
• K74 Fibrosis and cirrhosis of the liver
• K83.1 Bile duct obstruction
• K86.1 Other chronic pancreatitis
• K86.8 Other specified diseases of the pancreas
• K86.8.0* Hypofunction of the pancreas, exocrine
• K91 Digestive disorders following medical procedures, not elsewhere classified
• K91.5 Postcholecystectomy syndrome
• K92.8 Other specified diseases of the digestive system
• R54 Old age
• Z100* CLASS XXII Surgical practice

Composition and release form

Creon® 10000

10 pcs in blister; in a cardboard pack there are 2 blisters; 25 pcs in blister; in a cardboard pack there are 2 or 4 blisters; in polyethylene bottles of 20 and 50 pcs.; 1 bottle in a cardboard pack.

Creon® 25000

10 pcs in blister; in a cardboard pack there are 2 blisters; 25 pcs in blister; in a cardboard pack there are 2 or 4 blisters; in polyethylene bottles of 20 and 50 pcs.; 1 bottle in a cardboard pack.

Pharmacodynamics

An enzyme preparation that improves digestion processes. Pancreatic enzymes included in the drug facilitate the breakdown of proteins, fats, and carbohydrates, which leads to their complete absorption in the small intestine. Capsules containing enteric-coated mini-microspheres dissolve quickly in the stomach, releasing hundreds of mini-microspheres. The purpose of the multi-unit dose principle is to mix the mini-microspheres with the intestinal contents, and ultimately to better distribute the enzymes after their release within the intestinal contents.

Creon 10000 20 pcs. enteric capsules abbott laboratories gmbh/

pharmachologic effect

Digestive enzyme agent.

Composition and release form Creon 10000 20 pcs. enteric capsules abbott laboratories gmbh/

Capsules - 1 capsule:

• Active substance: pancreatin - 150 mg (which corresponds to 10,000 IU of Eur.F. lipase, 8,000 IU of Eur.F. amylase, 600 IU of Eur.F. protease.);
• Excipients: macrogol 4000 - 37.50 mg, hypromellose phthalate - 56.34 mg, dimethicone 1000 - 1.35 mg, cetyl alcohol - 1.18 mg, triethyl citrate - 3.13 mg;
• Hard gelatin capsule: gelatin - 60.44 mg, red iron oxide dye (E 172) - 0.23 mg, yellow iron oxide dye (E 172) - 0.05 mg, black iron oxide dye (E 172) - 0, 09 mg, titanium dioxide (E 171) - 0.07 mg, sodium lauryl sulfate - 0.12 mg.

20, 50 or 100 capsules in a white high-density polyethylene bottle with a polypropylene screw cap and tamper evident. A label is placed on the bottle. 1 bottle along with instructions for use in a cardboard box.

Description of the dosage form

Hard gelatin capsules No. 2, consisting of a brown opaque cap and a transparent colorless body.

The contents of the capsules are minimicrospheres of light brown color.

Directions for use and doses

Creon is taken orally. The dose of the drug depends on the age and degree of pancreatic insufficiency and is calculated in terms of lipase enzyme.

The average dose for adults is 150,000 units of lipase/day. In case of complete insufficiency of pancreatic function - 400,000 units/day, which corresponds to the daily requirement of an adult for lipase. The maximum daily dose is 15,000-20,000 units/kg of weight.

Children under 1.5 years of age are prescribed 50,000 units/day; over 1.5 years - 100,000 units/day. Capsules are taken with meals, swallowed whole with plenty of non-alkaline liquid (water, fruit juices).

Pharmacodynamics

An enzyme preparation that improves digestion processes. Pancreatic enzymes included in the drug facilitate the breakdown of proteins, fats, and carbohydrates, which leads to their complete absorption in the small intestine. Capsules containing enteric-coated mini-microspheres dissolve quickly in the stomach, releasing hundreds of mini-microspheres. The purpose of the multi-unit dose principle is to mix the mini-microspheres with the intestinal contents, and ultimately to better distribute the enzymes after their release within the intestinal contents.

Pharmacokinetics

When the mini-microspheres reach the small intestine, the enteric coating is destroyed, releasing enzymes with lipolytic, amylolytic and proteolytic activity, which ensure the breakdown of fats, starches and proteins.

Indications for use Creon 10000 20 pcs. enteric capsules abbott laboratories gmbh/

Creon is an enzyme preparation that improves digestion processes. Creon is used as replacement therapy for insufficiency of exocrine pancreatic function, for symptomatic treatment of digestive disorders in the following cases: conditions after cholecystectomy, partial resection of the stomach, total gastrectomy, duodeno- and gastrostasis, biliary obstruction, cholestatic hepatitis, cirrhosis of the liver, pathology of the terminal part of the small intestines, bacterial overgrowth in the small intestine.

Contraindications

Creon should not be taken in the early stages of acute pancreatitis, as well as in case of hypersensitivity to porcine pancreatin or to any other component of the drug.

Application Creon 10000 20 pcs. enteric capsules abbott laboratories gmbh/ during pregnancy and breastfeeding

The use of Creon is possible under the supervision of a physician.

special instructions

In patients with cystic fibrosis who received high doses of pancreatin preparations, strictures of the ileum, cecum and colon (fibrosing colonopathy) have been described. As a precaution, if unusual symptoms or changes in the abdominal cavity occur, medical examination is necessary to rule out fibrosing colonopathy, especially in patients taking the drug at a dose of more than 10,000 lipase units/kg per day.

Impact on the ability to drive vehicles and operate machinery

The use of the drug Krson® 10000 does not affect or has an insignificant effect on the ability to drive a car and operate machinery.

Overdose

Symptoms: hyperuricuria, hyperuricemia. Treatment: drug withdrawal, symptomatic therapy.

Side effects Creon 10000 20 pcs. enteric capsules abbott laboratories gmbh/

When using Creon, adverse reactions may occur, such as diarrhea, nausea, and allergic reactions.

Drug interactions

There are no reports of interaction with other drugs.

Indications of the drug Creon® 10000

replacement therapy for insufficiency of exocrine pancreatic function in cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, duct obstruction (pancreatic duct or common bile duct) due to neoplasm, Shwachman-Diamond syndrome, in old age;

symptomatic treatment of digestive disorders during partial gastrectomy (Billroth-I/II), total gastrectomy; after cholecystectomy, with duodeno- and gastrostasis, biliary obstruction, cholestatic hepatitis, liver cirrhosis, pathology of the terminal part of the small intestine, excessive bacterial growth in the small intestine.

Creon 10000 capsules No. 20

Creon 10000 capsules No. 20

Instructions for use Creon 10000 caps. No. 20

Dosage forms capsules 10000 units Synonyms Gastenorm forte Gastenorm forte 1000

Mezim 20000

Mikrasim Pangrol 10000 Pangrol 25000 Panzinorm 10000 Panzinorm forte 20000 Panzinorm forte-N Pancreazim Pancreatin Pancreatin forte Pancreatin-LekT Penzital Enzistal-P Ermital Group Enzyme agents that improve digestive processes International nonproprietary name Pancreatin Composition Active ingredient - pancreatin 150 mg, which corresponds to the content: lipase 10,000 units, amylase 8,000 units, protease 600. Manufacturers Abbott Products GmbH (Germany) Pharmacological action An enzyme preparation that improves digestive processes. Pancreatic enzymes included in the drug facilitate the digestion of proteins, fats, and carbohydrates, which leads to their complete absorption in the small intestine. The drug contains pancreatin in the form of mini-microspheres, enteric-coated, which quickly dissolve in the stomach, releasing hundreds of mini-microspheres. The purpose of this principle is to mix the mini-microspheres with the intestinal contents and, ultimately, to better distribute the enzymes after their release within the intestinal contents. When minimicrospheres reach the small intestine, the enteric coating is destroyed (at pH>5.5), pancreatic enzymes with lipolytic, amylolytic and proteolytic activity are released, which leads to the breakdown of fats, carbohydrates and proteins. The resulting substances are then either directly absorbed or further hydrolyzed by intestinal enzymes. Animal studies have demonstrated a lack of absorption of intact (uncleaved) enzymes and, as a consequence, classical pharmacokinetic studies have not been performed. Drugs containing pancreatic enzymes do not require absorption to exert their effects. On the contrary, the full therapeutic activity of these drugs is realized in the lumen of the gastrointestinal tract. Moreover, in their chemical structure they are proteins and, in connection with this, when passing through the gastrointestinal tract, they undergo proteolytic cleavage until they are absorbed in the form of peptides and amino acids. effects Gastrointestinal disorders. Very common (>=1/10): pain in the abdominal area. Often (>= 1/100, =1/1000, Indications for use Replacement therapy for insufficiency of exocrine pancreatic function in children and adults, caused by various diseases of the gastrointestinal tract and most often found in: cystic fibrosis; chronic pancreatitis; after pancreatic surgery gland; after gastrectomy; pancreatic cancer; partial gastrectomy (for example, Billroth II); obstruction of the pancreatic ducts or common bile duct (for example, due to a neoplasm); Shwachman-Diamond syndrome; condition after an attack of acute pancreatitis and resumption of nutrition. Contraindications Increased sensitivity to any of the components of the drug. Method of administration and dosage Orally. Doses of the drug are selected individually depending on the severity of the disease and the composition of the diet. Capsules should be taken during or immediately after each meal (including light snacks), swallowed whole, do not break or chew with sufficient liquid. If swallowing is difficult (for example, in small children or elderly patients), the capsules are carefully opened, and minimicrospheres are added to soft food that does not require chewing and has a sour taste (pH Overdose Symptoms: hyperuricuria and hyperuricemia. Treatment: discontinuation of the drug, symptomatic therapy. Interaction No studies have been conducted. Special instructions In patients with cystic fibrosis who received high doses of pancreatin preparations, strictures of the ileum, cecum and colon (fibrosing colonopathy) have been described. As a precaution, if unusual symptoms or changes in the abdominal cavity occur, medical examination is necessary to rule out fibrosing colonopathy, especially in patients taking the drug at a dose of more than 10,000 lipase units/kg per day. Like all currently used porcine pancreatin preparations, the drug is made from pancreatic tissue from pigs specially raised for human consumption. Although the potential for transmission of an infectious agent to humans has been minimized by testing and inactivation of certain viruses during the manufacturing process, there is a theoretical risk of transmission of viral disease, including diseases caused by new or unknown viruses. The presence of swine viruses that can infect humans cannot be completely excluded. However, over a long period of time using porcine pancreas extracts, not a single case of infectious disease transmission has been recorded. Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 25 C in tightly closed packaging.

Directions for use and doses

Inside. The dose is selected individually depending on the severity of the disease and the composition of the diet. It is recommended to take 1/3 or 1/2 of a single dose at the beginning of a meal, and the rest during meals. If swallowing is difficult (for example, in small children or elderly patients), the capsules are carefully opened, and mini-microspheres are added to liquid food that does not require chewing, or taken with liquid. Any mixture of mini-microspheres with food or liquid cannot be stored and should be taken immediately after preparation. Crushing or chewing mini-microspheres, as well as adding them to food with a pH above 5.5, leads to the destruction of their shell, which protects against the action of gastric juice.

For cystic fibrosis, the dose depends on body weight and is at the beginning of treatment in children under 4 years of age - 1000 lipase units / kg for each meal, over 4 years - 500 lipase units / kg during meals. The dose depends on the severity of symptoms of the disease, control of steatorrhea and maintenance of good nutritional status. In most patients, the dose should not exceed 10,000 units/kg/day.

For other conditions accompanied by exocrine pancreatic insufficiency, the dose is set taking into account the individual characteristics of the patient (degree of digestive insufficiency, fat content in food). The dose with the main meal (breakfast, lunch and dinner) is 20,000–75,000 IU of EP lipase, while taking a light snack - 5,000–25,000 IU of EP lipase.

The usual initial dosage of Creon® is 10,000–25,000 IU of EP lipase with the main meal. To reduce steatorrhea and maintain optimal patient condition, the dose may be increased. According to usual clinical practice, the patient should receive at least 20,000–50,000 units of EP lipase with food.

Creon 25000 300 mg No. 20 caps. with mk/spheres.

Trade name Creon® 25000 International nonproprietary name No Dosage form Capsules containing enteric-coated minimicrospheres, 300 mg Composition One capsule contains the active substance - pancreatin 300 mg, with minimal enzymatic activity: amylase - 18,000 Euro units. F., lipases - 25,000 EUR units. F., proteases - 1000 EUR units. F., produced from pancreatic tissue of porcine origin, excipients pellet core: macrogol 4000, pellet shell: hypromellose phthalate, cetyl alcohol, triethyl citrate, dimethicone 1000, capsule shell: gelatin, anhydrous iron oxide III (E 172), hydrated iron oxide III (E 172), titanium dioxide (E 171), sodium lauryl sulfate. Description Hard, gelatin capsules, size No. 0, with a red-brown cap and a colorless body, filled with brown mini-microspheres (pellets). Pharmacotherapeutic group Drugs that promote digestion (including enzyme preparations). Digestive enzyme preparations. Pancreatin Code ATC A09AA02 Pharmacological properties Pharmacokinetics It is known that intact enzymes are not absorbed, therefore classical studies on the pharmacokinetics of Creon® 25000 have not been conducted. Pancreatic enzymes do not require absorption to function. On the contrary, the full therapeutic effect occurs in the lumen of the gastrointestinal tract. Because they are protein molecules, enzymes undergo further proteolytic digestion as they move through the gastrointestinal tract until they are absorbed as peptides or amino acids. Pharmacodynamics Creon® 25000 capsules contain pancreatin of porcine origin in the form of minimicrospheres coated with an enteric (acid-resistant) coating. The capsule shell quickly dissolves in the stomach, releasing hundreds of minimicrospheres. In this case, minimicrospheres are mixed with chyme already in the stomach, which significantly increases the contact area between the food bolus and pancreatic enzymes. When the minimicrospheres reach the small intestine, their enteric coating is rapidly destroyed (at pH > 5.5) with the subsequent release of enzymes with lipolytic, amylolytic and proteolytic activities, resulting in the disintegration of fat, starch and protein molecules. The products of pancreatic digestion then undergo absorption or subsequent hydrolysis by intestinal enzymes. Results of clinical studies A total of 23 clinical studies of the effectiveness of Creon® were conducted in patients with exocrine pancreatic insufficiency. However, 7 of them were placebo-controlled or studies that assessed the effectiveness of treatment relative to the initial condition, involving patients with cystic fibrosis, chronic pancreatitis or after surgical interventions. In all randomized, placebo-controlled trials, the primary endpoint was the superiority of Creon® over placebo in the primary efficacy parameter, fat absorption coefficient (FA). All studies, regardless of disease etiology, showed significant improvements in specific symptoms (such as stool frequency and consistency, flatulence and abdominal pain). Children In cystic fibrosis, the effectiveness of Creon® has been demonstrated in three placebo-controlled studies in children and adolescents with cystic fibrosis, as well as in one baseline-controlled study in infants. A total of 118 patients participated in these studies. The dynamics of LCP shows that there are no differences in the effectiveness of Creon® due to the age of patients. Indications for use For replacement purposes in exocrine pancreatic insufficiency - cystic fibrosis - chronic pancreatitis - condition after pancreatectomy - pancreatic cancer - condition after complete or partial resection of the stomach (gastroenterostomy according to Billroth-II) - obstruction of the pancreatic ducts or common bile duct (in including due to neoplasm) - Shwachman-Diamond syndrome - acute pancreatitis during the period of restoration of enteral nutrition. Method of administration and dosage. Doses of the drug are selected individually depending on the severity of the disease and the composition of the diet. Creon® 25000 capsules are taken orally during meals. If it is necessary to take more than 1 capsule of Creon® 25000, take 1 capsule before and the rest during meals. Capsules should be swallowed whole, without breaking them or chewing them, with a sufficient amount of liquid. If swallowing is difficult (for example, in small children or elderly patients), the capsules are carefully opened, and the minimicrospheres are added to soft food that does not require chewing (for example, applesauce), or taken with liquid. In this case, the food or liquid with which the minimicrospheres are mixed must be acidic (fruit juice or yogurt) to prevent premature release and destruction of enzymes (pH <5.5). Chewing or damage to minimicrospheres may disrupt the protective enteric coating, resulting in premature release of enzymes that may cause irritation of the oral mucosa and/or reduce the therapeutic effect of the drug. Any mixture of minimicrospheres with food or liquid cannot be stored and should be taken immediately after preparation. It is important to constantly take enough fluid, especially if there is increased fluid loss. Not taking in enough fluids can cause constipation. If the patient forgot to take Creon® 25000 on time, you can take the missed dose immediately after a meal. A later appointment is not advisable. At your next meal, you should take the usual dose of the drug. Do not take a double dose to make up for a missed dose. Cystic fibrosis For cystic fibrosis, the dosage of the drug is selected by the attending physician. According to the recommendations of the American Cystic Fibrosis Foundation, the dose of Creon® 25000 is calculated in the number of lipase units per 1 kg of body weight per meal. Depending on age, a single dose is calculated as follows: Age of the child Recommendations Up to 4 years 1000 units. lipase per 1 kg of body weight Over 4 years 500 units. lipase per 1 kg of body weight Dosage and duration of treatment are determined depending on the severity of the disease, control of steatorrhea and maintenance of good nutritional status. In most patients, the dose should not exceed 10,000 lipase units/kg body weight per day or 4,000 lipase units per gram of fat in food. For optimal individual dosing, in addition to Creon® 25000, there is a dosage with a lower enzyme content. Since it is difficult to divide the contents of the Creon® 25000 capsule into several doses, it is recommended to start treatment in children weighing at least 25 kg. For use in children weighing less than 25 kg, a dosage with a lower enzyme content is recommended (Creon® 10000). Dosage for other conditions accompanied by exocrine pancreatic insufficiency. The dosage and duration of treatment should be determined taking into account the individual characteristics of the patient, which include the degree of digestive disturbance and the fat content of food. The dose that the patient requires along with main meals (lunch, breakfast or dinner) can vary from 25,000 to 80,000 units. lipase (Eur. F.), which is from 1 to 3 capsules of Creon® 25000, and when taking a light snack between meals, the dose is approximately half the individual dosage, or 1/2-2 capsules. Side effects Very common - abdominal pain* Common - nausea, vomiting, flatulence, diarrhea, constipation Uncommon - rash Frequency unknown - fibrosing colonopathy, hypersensitivity reactions (anaphylactic reactions), allergic skin reactions: urticaria, itching *Gastrointestinal disorders associated with main disease. The incidence of abdominal pain and diarrhea was similar to or lower than in the placebo group. Fibrosing colonopathy has been described in patients with cystic fibrosis who took high doses of drugs containing pancreatin. In clinical studies involving pediatric patients, no additional adverse reactions were identified. Contraindications - increased individual sensitivity to porcine pancreatin or any other component of the drug. Drug interactions There are no reports of interactions with other drugs or other forms of interaction. When taken simultaneously, the absorption of folic acid decreases, which requires an increase in the dose of the latter, as well as a decrease in the effect of the drugs acarbose and miglitol. Special instructions Strictures of the ileocecal angle and large intestine (fibrosing colonopathy) have been described in patients with cystic fibrosis who took high doses of pancreatin. As a precaution, it is recommended that any unusual symptoms or changes in the gastrointestinal tract be subjected to a thorough medical evaluation to rule out involvement of the colon. Especially if the patient takes more than 10,000 lipase units/kg body weight per day. Like other products containing pancreatins, Creon® 25000 is made from pancreatic tissue from pigs specially raised for human consumption. Although the risk of transmission of infectious agents to humans by Creon® 25000 has been minimized by testing and inactivating certain viruses during the manufacturing process, there is a theoretical risk of transmission of viral disease, including diseases caused by new or unidentified viruses. The presence of swine viruses that could infect humans cannot be completely excluded. However, to date there are no reports of infectious disease transmission associated with the use of porcine pancreatin, while this substance has been used for a long period of time. Pregnancy and lactation Creon® 25000 is prescribed with caution during pregnancy. Due to the lack of systemic absorption of pancreatic enzymes, during breastfeeding Creon® 25000 is prescribed in doses necessary to ensure adequate nutritional status. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Creon® 25000 does not affect the ability to drive a car or operate machines and mechanisms. Overdose Symptoms: Doses of Creon® 25000, much higher than therapeutic doses, can cause hyperuricosuria and hyperuricemia. Treatment: discontinuation of the drug, sufficient fluid intake, supportive measures. Release form and packaging 20, 50, 100 capsules in white high-density polyethylene bottles, sealed with a screw cap with a tamper evident device. Labels made of self-adhesive paper are glued onto the bottles. Each bottle, along with instructions for medical use in the state and Russian languages, is placed in a box made of cardboard. Storage conditions Store at a temperature not exceeding 25°C in tightly closed packaging. Keep out of the reach of children! Shelf life: 3 years Do not use after expiration date. Do not use after 3 months after opening the bottle. Conditions for dispensing from pharmacies Without a prescription Name and country of the manufacturing organization Abbott Laboratories GmbH, Germany. 31535, Neustadt am Rübenberge, Justus-von Liebig Strasse, 33. Name and country of the owner of the registration certificate Abbott Laboratories GmbH, Germany Name and country of the packing organization Abbott Laboratories GmbH, Germany Address of the organization receiving claims from consumers regarding product quality in the territory of the Republic of Kazakhstan : Representative office in the Republic of Kazakhstan, Dostyk Ave. 117/6, Business, 050059, Almaty, Republic of Kazakhstan. Tel.: +77272447544, fax: +77272447644. e-mail

special instructions

Strictures of the ileum and cecum and colitis have been described in patients with cystic fibrosis who received high doses of pancreatin preparations. In case-control studies, there was no evidence of a relationship with Creon and the occurrence of fibrosing colonopathy. As a precaution to exclude colonic involvement in patients with cystic fibrosis, it is recommended to monitor any unusual symptoms or changes in the abdominal cavity - especially if the patient is taking more than 10,000 IU lipase/kg/day.

The drug does not affect the ability to drive a car or control machines and mechanisms.