Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METRONIDAZOLE
ZUELLIG PHARMA SDN BHD
METRONIDAZOLE
15gm mcg/mL; 30gm mcg/mL; 5gm mcg/mL
LABS GALDERMA
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ROZEX ® GEL Metronidazole 0.75% 1 WHAT IS IN THIS LEAFLET 1. What Rozex Gel is used for 2. How Rozex Gel works 3. Before you use Rozex Gel 4. How to use Rozex Gel 5. While you are using it 6. Side Effects 7. Storage and disposal of Rozex Gel 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ROZEX GEL IS USED FOR Rozex Gel is used as topical application to treat pimples, _pustules_ (spots) and redness that develops with _rosacea_ condition. HOW ROZEX GEL WORKS Rozex Gel contains active ingredient _metronidazole_ which acts against harmful microorganisms to help control infection and inflammation in the skin due to _rosacea._ BEFORE YOU USE ROZEX GEL - _When you must not use it _ Rozex Gel must not be used in individuals with a history of hypersensitivity to _metronidazole_ , parabens, or other ingredients of the formulation. - _Before you start to use it _ Rozex Gel has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If local irritations occur, patient should be directed to use less frequently, discontinue use temporarily or discontinue use until further instruction. - _Taking other medicines _ Rozex Gel is expected to have minimal interactions with other medications. Individuals who are receiving anticoagulant treatment should inform their doctor, as absorption of metronidazole into the bloodstream may increase the anticoagulant (blood thinning) effect of such medication. HOW TO USE ROZEX GEL - _How much to use _ Apply and rub in a thin film of Rozex Gel twice daily, morning and evening, to the entire affected areas after washing. - _When to use it _ Apply twice daily, morning and evening. Cosmetics may be used after application of Rozex Gel. _How long to use it _ Improvement should be noticed within three weeks. Your doctor will decide how long you need to use Rozex Gel to keep your _rosacea_ under control. _If you forget to use it _ Although this gel works best if yo Preberite celoten dokument
R O Z E X ® m e t r o n i d a z o l e T O P I C A L G E L NOTICE RECTO 180x315 PLAN n° MT.09.DRA.0352.R02.2 COMPOSITION ROZEX Gel contains metronidazole 0.75% as the active ingredient in a single phase, colourless to pale yellow, viscous and homogenous gel containing purified water, methylparaben, propylparaben, propylene glycol, carbomer 940, disodium edetate and sodium hydroxide. PHARMACEUTICAL FORM ROZEX Gel is for cutaneous use only. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMICS: Metronidazole has an antibacterial and antiprotozoal effect against a large number of pathogenic micro- organisms. The mechanism of action of metronidazole in rosacea is not known but pharmacological data available suggest that the activity is based on an antibacterial and / or anti-inflammatory action. PHARMACOKINETICS: Following a single, topical 7.5mg application of ROZEX Gel to the face of ten rosacea patients (aged 36 to 70 years), the maximum metronidazole serum concentration (C max ) ranged from below detectable limits (n =3) to 66 ng/mL, with a mean in the seven patients with quantifiable serum concentrations of 40.6 ng/mL. The mean C max following 30 mg oral dose of a 5 mg/mL metronidazole solution administered in the same patients was 850 ng/mL. When corrected for the dose difference between formulations, the estimated C max for the oral solution is 212 ng/mL. The difference in C max between the two formulations was significant (p < 0.01). The time of the maximum serum concentration (T max ) was also found to be significantly (p < 0.01) different between the two formulations. The median Tmax was 5.98 hours with the topical gel as compared to 0.97 hours with the oral solution. An accurate estimation of the area under the curve (AUC) following the topical 0.75% gel was not possible because of undetectable serum concentrations at the majority time points. The mean (%CV) AUC following the oral solution was 7476.1 (35.8%) ng.hr/mL. Serum metronidazole and the hydroxymethyl metabolite (2-hydroxymethylmetronidazole) were below the Preberite celoten dokument