País: República de Sud-àfrica
Idioma: anglès
Font: South African Health Products Regulatory Authority (SAHPRA)
Schering
CREON 25 000 capsules SCHEDULING STATUS: S1 PROPRIETARY NAME (and dosage form): CREON 25 000 capsules COMPOSITION Per capsule: pancreatin 300 mg. The enzyme activities per capsule are: Amylase : 18 000 FIP units* Lipase : 25 000 FIP units Protease : 1 000 FIP units * FIP = Fédération Internationale Pharmaceutique PHARMACOLOGICAL CLASSIFICATION A. 11.1 Digestants. PHARMACOLOGICAL ACTION Creon 25 000 (pancreatin) substitutes pancreatic enzymes if they are deficient. The capsule dissolves rapidly in the stomach releasing the enzymes in micro-encapsulated pellets. The enteric coating of the pellets has been formulated to resist inactivation by gastric acid, but is rapidly dissolved in the alkaline pH of the duodenum, thus releasing the enzymes at the appropriate site. The enzymes become dispersed in the duodenum and digest fats, proteins and carbohydrates. INDICATIONS Supplement for pancreatic exocrine insufficiency which may be caused by: - chronic pancreatitis - cystic fibrosis - partial pancreatectomy CONTRA-INDICATIONS - Patients with a known hypersensitivity to pig proteins. - Early stages of acute pancreatitis (due to the fact that patients are not allowed to eat for the first two to three days). Safety of Creon 25 000 in pregnancy has not been established. DOSAGE AND DIRECTIONS FOR USE The dose of pancreatin must be adjusted according to the needs of the individual patient. Initially one Creon 25 000 capsule should be taken, with liquid, with meals. If necessary, the dosage can be increased. Children with cystic fibrosis who are taking, or have been given in excess of 10 000 units of lipase/kg/day are at risk of developing colon damage. The capsule should be swallowed whole, without chewing. Alternatively the capsule may be Llegiu el document complet