Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NATAMYCIN
LINK HEALTHCARE SDN. BHD.
NATAMYCIN
15ml mL
ALCON LABS INC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 NATACYN OPHTHALMIC SUSPENSION Natamycin (50mg/ml) WHAT IS IN THIS LEAFLET 1. What NATACYN is used for 2. How NATACYN works 3. Before you use NATACYN 4. How to use NATACYN 5. While you are using NATACYN 6. Side effects of NATACYN 7. Storage and Disposal of NATACYN 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT NATACYN IS USED FOR Natacyn is used to treat the fungal infections of the eye. HOW NATACYN WORKS Natacyn contains natamycin which is anti-fungal. BEFORE YOU USE NATACYN - _When you must not use it_ Do not use Natacyn if you are allergic to natamycin or any of the other ingredients of this medicine. _Pregnancy and breast-feeding_ If you are pregnant or breastfeeding, you think you may be pregnant or are planning to have baby, ask your doctor or pharmacist for advice before using this medicine. - _Before you start to use it_ _ _ Talk to your doctor or pharmacist before using Natacyn. If your symptoms do not improve, get worse or suddenly return, please consult your doctor. • If you notice any signs of drug toxicity such as pain, itching, swelling or redness of the eye with Natacyn, discontinue use and consult your doctor. A preservative in Natacyn (benzalkonium chloride) may cause eye irritation and is also known to discolor soft contact lenses. Avoid contact with soft contact lenses. Contact lenses wear is not recommended during treatment of eye infection. - _Taking other medicines_ Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Caution is required in the use of corticosteroids because they can adversely affect the efficacy of antifungal. HOW TO USE NATACYN - _How much to use_ The recommended initial dosage in fungal keratitis is one drop of Natacyn instilled in the conjunctival sac at hourly or two-hourly intervals. Always use this medicine exactly as your doctor has told you. - _When to use it_ Use as directed by your doctor or pharm Baca dokumen lengkap
1. NAME OF THE MEDICINAL PRODUCT NATACYN ® OPTHALMIC SUSPENSION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Preservative: benzalkonium chloride For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension White to yellow 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NATACYN ® is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including _Fusarium solani _keratitis. As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response. Whenever possible the _in vitro _activity of natamycin against the responsible fungus should be determined. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The preferred initial dosage in fungal keratitis is one drop of NATACYN® (natamycin ophthalmic suspension, USP) 5% instilled in the conjunctival sac at hourly or two-hourly intervals. The frequency of application can usually be reduced to one drop 6 to 8 times daily after the first 3 to 4 days. Therapy should generally be continued for 14 to 21 days or until there is resolution of active fungal keratitis. In many cases, it may be helpful to reduce the dosage gradually at 4 to 7 days intervals to assure that the replicating organism has been eliminated. Less frequent initial dosage (4 to 6 daily applications) may be sufficient in fungal blepharitis and conjunctivitis. METHOD OF ADMINISTRATION • For ocular use. • Shake well before using. • To prevent contamination of the dropper tip and suspension, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. • If more than one topical ophthalmic medicinal product is being used, the medicines must be administered 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL Baca dokumen lengkap