Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ACTIVATED CHARCOAL
RX PHARMA SDN BHD
ACTIVATED CHARCOAL
30Capsule Capsules
NORIT NEDERLAND B.V
COMPOSITION: Each capsule contains 200 mg Activated Charcoal as active ingredient. PRODUCT DESCRIPTION: Norit capsules contains activated charcoal which is a fine, black, insoluble powder without taste or odor in black hard gelatin capsule that has a unique shorter and wider shape. ROUTE OF ADMINSTRATION: Oral PHARMACODYNAMICS: Mechanism of Action: Activated charcoal is obtained by destructive distillation of organic material, coconut shells (which contain high carbon content and low ash and tar content), which are then ‘activated’ by exposing it to oxidizing STEAM at approximately 1000ºC high temperature (in depleted oxygen environment), resulting in the production of vastly increased surface area from the creation of pores (with controlled pore size). The drug has the ability to adsorb a wide variety of substances onto its surface. This property can be applied in preventing the absorption of various harmful substances, which are responsible for diarrhea cases (traveler’s disease), from the gastrointestinal tract and various drugs and toxicants involved with oral poisonings. Norit activated charcoal has fulfilled the requirements of USA/ EUROPEAN PHARMACOPOEIA for its adsorption capacity of ≥ 38% VS METHYLENE BLUE and ≥ 40% PHENAZONE respectively (the references test compounds in both respective pharmacopoeia). Adsorption of substances onto charcoal is a reversible process with rapid adsorption and slow resorption. The rate of adsorption depends on the particle size, viscosity of the medium, pH (acids and bases) and the amount and type of gastrointestinal contents. PHARMACOKINETICS: Since activated charcoal is not absorbed from the gastro intestinal tract, there is no distribution phase nor any metabolism. The complex between activated carbon and the adsorbed compounds may only be passed in the stool. Norit activated charcoal is compliance with ICH Q3D guidelines on elemental impurities. NORIT CAPSULE 200 MG ACTIVATED CHARCOAL INDICATIONS: Norit is indicated as gastrointestinal absorbent in the treatm Прочитајте комплетан документ