Krajina: Južná Afrika
Jazyk: angličtina
Zdroj: South African Health Products Regulatory Authority (SAHPRA)
Hexal
CICLOHEXAL 25 (soft gelatine capsules) CICLOHEXAL 100 (soft gelatine capsules) CICLOHEXAL ORAL (100 mg/1 mL oral solution) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): CICLOHEXAL 25 (soft gelatine capsules) CICLOHEXAL 100 (soft gelatine capsules) CICLOHEXAL ORAL (100 mg/1 mL oral solution) COMPOSITION Each CicloHexal 25 soft gelatine capsule contains 25 mg ciclosporin . Ethanol content 25,8%v/v (absolute) Each CicloHexal 100 soft gelatine capsule contains 100 mg ciclosporin. Ethanol content 25,8%v/v (absolute) Each 1 mL oral solution contains 100 mg ciclosporin. Ethanol content 25,8%v/v (absolute). PHARMACOLOGICAL CLASSIFICATION A 34 Other. PHARMACOLOGICAL ACTION Ciclosporin is a cyclic polypeptide consisting of 11 amino acids and it is a potent immunosuppressive agent. The exact mechanism of action of ciclosporin is not yet known. It has been suggested, based on animal studies, that ciclosporin inhibits the development of cell mediated reactions, including allograft immunity, delayed cutaneous hypersensitivity, experimental allergic encephalomyelitis, Freund adjuvant arthritis, graft versus host disease and also T- cell dependent anti-body production. It seems as though ciclosporin blocks the resting lymphocytes in the G 0 or early G 1 phase of the cell cycle. Lymphokine production, as well as the release of interleukin2, (T cell growth factor -TCGF), is also inhibited. Evidence suggests that ciclosporin acts specifically and reversibly on the lymphocytes. Pharmacokinetics. CicloHexal soft gelatine capsules and CicloHexal oral solution are bio-equivalent. The substance is extensively bio-transformed to approximately 15 metabolites, possessing little or no pharmacological activity. Parent drugs and the metabolites are excreted mainly via the bile, with only 6% of the oral dose excr Prečítajte si celý dokument