País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GATIFLOXACIN
Allergan Malaysia Sdn Bhd
GATIFLOXACIN
5ml mL
Allergan Sales, LLC
ZYMAR™ gatifloxacin (0.3%) Ophthalmic Solution 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What ZYMAR™ is used for 2. How ZYMAR™ works 3. Before you use ZYMAR™ 4. How to use ZYMAR™ 5. While you are using it 6. Side effects 7. Storage and Disposal of ZYMAR™ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 1. WHAT ZYMAR™ IS USED FOR ZYMAR™ is used to treat the signs and symptoms of bacterial eye surface inflammation in patients 1 year of age or older. 2. HOW ZYMAR™ WORKS ZYMAR™ is an antibiotic eye drop used to treat bacterial eye infections. ZYMAR™ kills many kinds of bacteria that can cause infections of the eye and is ineffective against viruses. 3. BEFORE YOU USE ZYMAR™ - _When you must not use it _ _ _ Do not use ZYMAR™ : - If you are allergic (hypersensitive to gatifloxacin, or any of the other ingredients of ZYMAR™ . (for a full list of ingredients, see section 8 “PRODUCT DESCRIPTION”). - If you have ever had an allergic reaction to gatifloxacin Tablets or I.V., or any medicine in the group of antibiotics known as “quinolones”, such as ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, or norfloxacin. - _Pregnancy and lactation _ Ask your doctor or pharmacist for advice before using ZYMAR™ if you are pregnant, trying to get pregnant or think you may be pregnant. Ask your doctor or pharmacist for advice before using ZYMAR™ if you are breast-feeding. - _Children _ ZYMAR™ is not recommended for children under 1 year of age. - _Before you start use it _ Take special care with ZYMAR™ . If you have allergies to other medications, discuss with your doctor before taking ZYMAR™ . - _Taking other medicines _ Discuss with your doctor if you are taking other eye drops other than ZYMAR™ . Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. 4. HOW TO USE ZYMAR™ - _How much to use _ The recom Leia o documento completo
ZYMAR ™ (GATIFLOXACIN OPHTHALMIC SOLUTION) 0.3% STERILE DESCRIPTION ZYMAR™ (gatifloxacin ophthalmic solution) 0.3% is a sterile ophthalmic solution. It is an 8-methoxy fluoroquinolone anti- infective for topical ophthalmic use. CHEMICAL NAME: (±)-1-cyclopropyl-6-fluoro-1,4-dihydro-8- methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3- quinolinecarboxylic acid sesquihydrate CONTAINS: ACTIVE: gatifloxacin 0.3% (3 mg/mL). PRESERVATIVE: benzalkonium chloride 0.005%. INACTIVES: edetate disodium; purified water and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH to approximately 6. ZYMAR™ is a sterile, clear, pale yellow colored isotonic unbuffered solution. It has an osmolality of 260-330 mOsm/kg. CLINICAL PHARMACOLOGY PHARMACOKINETICS: Gatifloxacin ophthalmic solution 0.3% or 0.5% was administered to one eye of 6 healthy male subjects each in an escalated dosing regimen starting with a single 2 drop dose, then 2 drops 4 times daily for 7 days and finally 2 drops 8 times daily for 3 days. At all time points, serum gatifloxacin levels were below the lower limit of quantification (5 ng/mL) in all subjects. MICROBIOLOGY: Gatifloxacin is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl substituent at C7. The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. The mechanism of action of fluoroquinolones including gatifloxacin is different from that of aminoglycoside, macrolide, and tetracycline antibiotics. Therefore, gatifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to gatifloxacin. There is no cross-resistance between gatifloxacin and the aforementioned classes of antibiotics. Cross resistan Leia o documento completo