Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Chlorhexidine Gluconate; MICONAZOLE NITRATE
PET ARCADE SDN BHD
Chlorhexidine Gluconate; MICONAZOLE NITRATE
Ensign Laboratories Pty Limited
PACKAGE INSERT Product Name DERMCARE MALASEB® MEDICATED SHAMPOO Active Substance Chlorhexidine gluconate 20g/L Miconazole nitrate 20g/L Description A topical keratolytic, antibacterical, antifungal and antipruritic shampoo for dogs and cats. Pharmacodynamics/ Pharmacokinetics The primary pharmacodynamic action of the active substances is antimicrobial. Miconazole is an imidazole with market antifungal and anti-yeast activity. The fungicidal action of the imidazole compounds, including miconazole, is by inhibition of ergosterol incorporation into membranes, so increasing concentrations of cytotoxic hydrogen peroxide accumulate within the fungal cell wall. Chlorhexidine is an antiseptic with broad spectrum activity. It is effective against many Gram negative and Gram positive bacteria. Chlorhexidine is absorbed onto bacterial membranes and interferes with membrane functions such as the sodium and potassium ATPase pump. At bacteriostatic concentrations, lysis of the membrane occurs, but at bactericidal concentrations, coagulation of the cytoplasm occurs without cell rupture. Chlorhexidine gluconate and miconazole nitrate possess virtually no secondary pharmacodynamics properties. Miconazole is poorly absorbed from the skin and gastrointestinal tract. Systemically available miconazole is metabolised in the liver and the metabolites excreted in the urine and faeces. Therefore, the combination of poor absorption and hepatic metabolism following topical application of this drug to dogs would not result in significant systemic concentrations of the drug either by absorption through the skin or by ingestion if the dog licked its coat or a lesion. Environmental Not applicable. Indication For the treatment of seborrhoeic dermatitis associated with infectious by _Staphylococcus _ _intermedius_, _Malassezia _ _(Pityrosporum) _ _pachydermatis_ and an aid in the treatment of dermatophyte (Ringworm) infections due to _Microsporum _ _canis_, _Microsporum _ _gypseum_ and _Trichophyton _ _mentagrophytes_ in dogs and cats by decrea Przeczytaj cały dokument