Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Amorolfine Hydrochloride
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
Amorolfine Hydrochloride
2.5 ml
GLENMARK PHARMACEUTICALS LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 OFLOMIL NAIL LACQUER 5% W/V AMOROLFINE HYDROCHLORIDE 5% W/V WHAT IS IN THIS LEAFLET 1. What _Oflomil_ is used for 2. How _Oflomil_ works 3. Before you use _Oflomil_ 4. How to use _Oflomil_ 5. While you are using it 6. Side Effects 7. Storage and Disposal of _Oflomil_ 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision 12. Serial Number WHAT _OFLOMIL_ IS USED FOR _Oflomil_ is used to treat fungal infections of the nails. HOW _OFLOMIL_ WORKS _Oflomil _ is a topical antimycotic, containing active ingredient amorolfine (as amorolfine hydrochloride). It belongs to a new chemical class, and its fungicidal action is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. Amorolfine from nail lacquer penetrates into and diffuses through the nail plate and is thus able to eradicate poorly accessible fungi in the nail bed. Systemic absorption of the active ingredient is very low with this type of application. Microbiology Amorolfine is a broad spectrum antimycotic. It is highly active (MIC < 2mcg/ml) _in vitro_ against _yeasts: Candida, Cryptococcus, _ _Malassezia _ _dermatophytes: Trichophyton, _ _Microsporum, Epidermophyton _ _moulds: Hendersonula, Alternaria, _ _Scopulariopsis _ _dematiacea: Cladosporium, Fonsecaea, _ _Wangiella _ _dimorphic _ _fungi: _ _Coccidioides, _ _Histoplasma, Sporothrix _ _ _ With the exception of _Actinomyces_ , bacteria are not sensitive to amorolfine. _Propionibacterium _ _acnes_ is only slightly sensitive. BEFORE YOU USE _OFLOMIL_ - _When you must not use it _ _ _ DO NOT USE _OFLOMIL_ IF YOU ARE: Allergic (hypersensitive) to amorolfine or any of the other ingredients of _Oflomil. _ Please check list of ingredients _ _ stated under _ _PRODUCT DESCRIPTION section. If you answer yes, you must inform your doctor before starting treatment. Please seek immediate medical attention if you experience symptoms of an allergic reaction. Signs or sympto Lue koko asiakirja
SAME SIZE ARTWORK LEAFLET SIZE : 176 mm x 186 mm 22 mm 24 mm Manufactured by: B/2, Mahalaxmi Chambers, 22, Bhulabhai Desai Road, Mumbai - 400 026, (India). At: Plot No. E-37, 39, D-Road, MIDC, Satpur, Nashik - 422 007, Maharashtra State, India ® Registered Trade Mark PE00000 MY PANTONE BLACK PROCESS C SUPERSEDES ARTWORK CODE PANTONE SHADE ICONGRAPHICS CODE: PHARMACODE: SPACE FOR PHARMACODE SPACE FOR PHARMACODE SPACE FOR PHARMACODE SPACE FOR PHARMACODE PRODUCT REGISTRATION HOLDER Glenmark Pharmaceuticals (Malaysia) Sdn Bhd (660397-W) D-31-02, Menara Suezcap 1,No. 2, Jalan Kerinchi, 59200 Kuala Lumpur, Malaysia. COMPOSITION Amorolfine Hydrochloride Ph.Eur equivalent to Amorolfine 5% w/v Absolute Alcohol 63.5% v/v Base q.s.. PHARMACEUTICAL FORM Nail Lacquer CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Onychomycoses caused by dermatophytes, yeasts and moulds POSOLOGY AND METHOD OF ADMINISTRATION The nail lacquer should be applied to the affected finger or toe nails once weekly. Twice weekly application may prove beneficial in some cases. The patient should apply the nail lacquer as follows: 1.Before the first application of Amorolfine Nail Lacquer, it is essential that the affected areas of nail (particularly the nail surfaces) should be filed down as thoroughly as possible using the nail file supplied. The surface of the nail should then be cleansed and degreased using a cleaning pad (as supplied). Cosmetic nail lacquer may be applied at least 10 min after amorolfine 5% nail lacquer application. Before repeat application of Amorolfine Nail Lacquer, any remaining nail lacquer, and cosmetic nail lacquer if any, should be removed carefully, then the affected nails should be filed down again as required, and at any rate be cleansed with an alcohol soaked swab to remove any remaining lacquer. _Caution:_ Nail files used for affected nails must not be used for healthy nails. 2.With one of the reusable applicators supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry. After use, c Lue koko asiakirja