Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
PANCREATIN
ABBOTT MEDICAL LABORATORIES LTD, ISRAEL
A09AA02
CAPSULES
PANCREATIN 150 MG
PER OS
Not required
ABBOTT LABORATORIES GMBH , GERMANY
MULTIENZYMES (LIPASE, PROTEASE ETC.)
MULTIENZYMES (LIPASE, PROTEASE ETC.)
Pancreatic exocrine insufficiency.
2022-02-23
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed without a doctor’s prescription CREON 10,000 CAPSULES Each capsule contains: Pancreatin 150 mg, comprising: Lipase 10,000 Ph. Eur. Units Amylase 8,000 Ph. Eur. Units Protease 600 Ph. Eur. Units For 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. Use this medicine in the correct manner. Consult a pharmacist if you need further information. - Creon 10,000 is a 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 capsules must 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 and malabsorption of lipids also related to the pancreas. THERAPEUTIC GROUP: Digestive enzymes. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: you are sensitive (allergic) to the active ingredient, pancreatin, to products of pig origin, pig proteins or to any of the additional ingredient Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS CREON ® 10,000 1. NAME OF THE MEDICINAL PRODUCT Creon ® 10,000, Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: 150 mg pancreatin (pancreas powder) corresponding to Amylase 8,000 Ph.Eur. units Lipase 10,000 Ph.Eur. units Protease 600 Ph.Eur. units For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Brown/clear capsules containing gastro-resistant granules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of Pancreatic exocrine insufficiency. 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 to two capsules with each meal. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology. 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 important that they are taken immediately and the mixture not stored, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed Crushing and chewing of the minimicrospheres or mixing with food or flui Прочитайте повний документ