Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
MEPHARM (MALAYSIA) SDN BHD
DICLOFENAC SODIUM
100Capsule Capsules
Acino Pharma AG
Olfen ® -100 SR _Depocaps_ ® _ _ _ _ _Antirheumatic _ _agent _ _with _ _anti-inflammatory _ _and _ _antipyretic _ _properties _ _ _ _ _ Composition Each Olfen-100 SR Depocaps ® contains: Diclofenac sodium 100mg (as sustained-release pellets) Properties and actions Olfen contains the sodium salt of diclofenac, a non-steroidal active substance having pronounced anti-rheumatic, anti-inflammatory, analgesic and anti-pyretic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated experimentally, is thought to be important for the mechanism of action. Prostaglandins play an essential role in the development of inflammation, pain and fever. The anti-inflammatory and analgesic properties become clinically evident in the case of rheumatic disorders in that the symptoms, such as rest pain, pain on motion, morning stiffness, swelling of the joints, are significantly improved and functional ability increases. In post- traumatic/post- operative inflammations, diclofenac causes a rapid reduction in spontaneous pain and pain on motion and reduces inflammatory swelling and wound oedema. For moderate and severe states of pain of a non-rheumatic type, as well, the pronounced analgesic effect was demonstrated in clinical trials. In cases of primary dysmenorrhoea, diclofenac can alleviate pain and reduce the extent of bleeding. Pharmacokinetics After oral administration, diclofenac is rapidly and completely absorbed. The plasma concentrations are linearly dose-dependent. Plasma protein binding amounts to more than 97%. Peak plasma concentrations are attained 1-4 hours after taking the enteric-coated Lactab tablets. The therapeutic plasma concentration range is 0.7- 2mcg/ml. Diclofenac undergoes first pass metabolism. Elimination is about 2/3 renal and about 1/3 via the bile in metabolized form (about 90% of the administered dose in 96 hours). The greater amounts of the hydroxyl-glucuronide and sulphated metabolites are biologically inactive. Only about 1% is renally excreted in unchanged form. The plasma Perskaitykite visą dokumentą