Država: Izrael
Jezik: angleščina
Source: Ministry of Health
PANCREATIN
ABBOTT MEDICAL LABORATORIES LTD, ISRAEL
A09AA02
CAPSULES
PANCREATIN 300 MG
PER OS
Required
ABBOTT LABORATORIES GMBH , GERMANY
MULTIENZYMES (LIPASE, PROTEASE ETC.)
MULTIENZYMES (LIPASE, PROTEASE ETC.)
For the treatment of pancreatic exocrine insufficiency.
2020-08-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only CREON 25,000 CAPSULES Each capsule contains: Pancreatin 300 mg, comprising: Lipase 25,000 Ph. Eur. Units Amylase 18,000 Ph. Eur. Units Protease 1,000 Ph. Eur. Units For a list of the inactive ingredients in the medicine, see section 6. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. - Creon 25,000 is a high-dosage pancreatic enzyme supplement indicated for people whose bodies cannot produce enough enzymes required to digest food. - The capsules contain a mix of natural enzymes used to digest food. - The enzymes are extracted from pig pancreas. - The medicine should be taken as per the doctor’s instructions. - Take the medicine together with a meal or snack, with a lot of water (see section 3). - Do not take the medicine if you are allergic to pig-derived ingredients, pig proteins (see section 2). - If you experience SEVERE ABDOMINAL PAINS during the course of treatment with the medicine, refer to the doctor immediately (see section 4). 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended to treat exocrine pancreatic insufficiency. The medicine contains pancreatic enzymes which aid digestion, in cases where the pancreas does not produce these enzymes, or does not produce enough of them. The medicine is intended to balance low enzymatic activity in the intestine, in cases of pancreatic insufficiency, e.g., cystic fibrosis, chronic pancreatitis, excision of the pancreas and partial excision of the digestive system in adults and children. THERAPEUTIC GROUP: Digestive enzymes. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: you are sensitive ( Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS CREON ® 25000 1. NAME OF THE MEDICINAL PRODUCT CREON ® 25000, CAPSULES 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule Creon 25000 contains 300 mg pancreatin (pancreas powder) corresponding to: Amylase 18,000 Ph.Eur. units Lipase 25,000 Ph.Eur. units Protease 1,000 Ph.Eur. units 3. PHARMACEUTICAL FORM Gastro-resistant capsule, hard (hard gelatin capsules filled with gastro-resistant pellets (=Minimicrospheres™). Bicoloured capsule with Swedish orange opaque cap and transparent body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of pancreatic exocrine deficiency. Enzyme replacement therapy in patients with deficient exocrine pancreatic secretions, cystic fibrosis, chronic pancreatitis, postpancreatectomy, ductal obstructions caused by cancer of the pancreas, pancreatic insufficiency and for steatorrhea of malabsorption syndrome and postgastrectomy (Billroth II and Total). Presumptive test for pancreatic function, especially in pancreatic insufficiency due to chronic pancreatitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The posology aims at individual needs and depends on the severity of the disease and the composition of food. It is recommended to take the enzymes during or immediately after each meal or snack. _ _ _Adults (including the elderly) and children: _ Initially one capsule with meals. Dose increases, if required, should be added slowly with careful monitoring of response and symptomatology. For infants and children a median lipase intake of 10,000 Ph.Eur. units per kg body weight a day is recommended. A daily lipase intake of 15,000 - 20,000 Ph.Eur. units per kg body weight should not be exceeded. The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing. This could be apple sauce or yoghurt or any fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice. If the granules are mixed with fluid or food, it is impor Preberite celoten dokument