Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amylase; Lipase; Protease
Essential Pharma Ltd
A09AA02
Amylase; Lipase; Protease
30000unit ; 25000unit ; 1400unit
Powder for gastroenteral or oral liquid
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 01090400; GTIN: 5015001141022
Tear here, BUT DO NOT REMOVE EAN CODE EAN CODE Batch no.: Manuf. date: Expiry date: PanVPow-LPL-UK-1 PanVPow-LPL-UK-1 PanVPow-LPL-UK-1 P P CONTAINS LACTOSE. SEE LEAFLET FOR FURTHER INFORMATION CONTAINS LACTOSE. SEE LEAFLET FOR FURTHER INFORMATION IN THIS LEAFLET: 1. What Pancrex V Powder is and what it is used for 2. Before you take Pancrex V Powder 3. How to take Pancrex V Powder 4. Possible side effects 5. How to store Pancrex V Powder 6. Further information 1. WHAT PANCREX V POWDER IS AND WHAT IT IS USED FOR The active ingredient in Pancrex V Powder is PANCREATIN. Pancreatin is a combination of enzymes normally produced by the pancreas which help to digest protein, fat, starch and sugars in the food that you eat. Pancreatin is given to people who do not produce enough enzymes to digest their food properly, in conditions such as cystic fibrosis, persistent inflammation of the pancreas, and when the pancreas has been removed. Pancrex V Powder may also be used when the stomach has been removed, as an aid to digestion. The pancreatin in Pancrex V Powder is derived from pancreases of pigs. 2. BEFORE YOU TAKE PANCREX V POWDER DO NOT TAKE PANCREX V POWDER IF YOU • are ALLERGIC (hypersensitive) to PANCREATIN There are no known diseases that may prevent you from taking Pancrex V Powder. TAKING OTHER MEDICINES Pancrex V Powder is not known to interfere with any other medicines that you may be taking. However, if you are prescribed another medicine, inform the doctor you are taking Pancrex V Powder. PREGNANCY AND BREAST-FEEDING If you are pregnant, thinking of becoming pregnant or breast-feeding, discuss this with your doctor before taking your medicine as dose adjustments may be necessary. Ask your doctor or pharmacist for advice before taking any medicine. DRIVING AND USING MACHINES Pancrex V Powder does not interfere with your ability to drive or operate machinery. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF PANCREX V POWDER • LACTOSE If you have been told by your doctor that you have an intolerance to Baca dokumen lengkap
OBJECT 1 PANCREX V POWDER Summary of Product Characteristics Updated 10-Feb-2017 | Essential Pharmaceuticals Ltd 1. Name of the medicinal product Pancrex V Powder 2. Qualitative and quantitative composition Pancreatin BP to provide enzymatic activity per gram not less than: Free protease 1400 BP units Lipase 25000 BP units Amylase 30000 BP units 3. Pharmaceutical form Powder. 4. Clinical particulars 4.1 Therapeutic indications Pancrex is used to compensate for reduced intestinal enzyme activity in pancreatic deficiency states. It is indicated for the treatment of fibrocystic disease of the pancreas (cystic fibrosis), chronic pancreatitis and pancreatic steatorrhoea following pancreatectomy. It may also be indicated following gastrectomy as an aid to digestion. 4.2 Posology and method of administration Posology Dosage should be adjusted according to the needs of the individual patient and the amount and type of food consumed. The following dosage ranges provide a suitable basis for adjustment. Adults, the Elderly, and Children 0.5 g - 2 g swallowed dry or mixed with a little water or milk before each snack or meal. New-born infants 0.25 g - 0.5 g with each feed. Method of administration (1) Oral (2) Pancrex V Powder may be administered via a nasogastric tube or a gastrostomy tube. Refer to relevant local and national official guidelines (see section 4.4). 4.3 Contraindications Hypersensitivity to the active ingredient (porcine pancreatin) or to any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use It is possible that some irritation of the skin of the mouth may occur if the powder is retained in the mouth. Irritation of the anus may also occur. A barrier cream may prevent this local irritation. Allergic/asthmatic reactions have occasionally occurred on handling the powder. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose- galactose malabsorption should not take this medicine. If the powder is mixed with liquids or feeds the Baca dokumen lengkap