Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GATIFLOXACIN
Allergan Malaysia Sdn Bhd
GATIFLOXACIN
5ml mL; 2.5ml mL
Allergan Sales, LLC
ZYMAXID ™ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ (gatifloxacin ophthalmic solution) 0.5% 1 WHAT IS IN THIS LEAFLET? 1. What ZYMAXID ™ is used for 2. How ZYMAXID ™ works 3. Before you use ZYMAXID ™ 4. How to use ZYMAXID ™ 5. While you are using it 6. Side effects 7. Storage and disposal of ZYMAXID ™ 8. Product description 9. Manufacturer and product registration holder 10. Date of revision 1. WHAT ZYMAXID ™ IS USED FOR ZYMAXID ™ is an antibiotic eye drop and is used for the treatment of conjunctivitis caused by bacteria. 2. HOW ZYMAXID ™ WORKS ZYMAXID ™ is an antibacterial drug that interferes with DNA replication, thus causing bacterial death. 3. BEFORE YOU USE ZYMAXID ™ _When you must not use it_ Do not use ZYMAXID ™ : - If you are hypersensitive (allergic) to gatifloxacin, other quinolones or to any of the components of ZYMAXID ™ (for a full list of ingredients, see section 8 “PRODUCT DESCRIPTION”). _Pregnancy and lactation _ If you are pregnant or breast feeding your baby, you should not use ZYMAXID ™ . It is not known whether this medicine is excreted in human milk. _Children _ Do not use in infants under the age of one year. _Before you start to use it_ Benzalkonium chloride: Special care should be taken if you have an extensive eye surface disease. You should not wear your contact lenses if your eye is red, and while using ZYMAXID ™ . _Taking other medicines_ The safety of using ZYMAXID ™ together with other medicines has not been determined. 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 ZYMAXID ™ _How much to use _ The usual dose for children of age 1 year and above & adults is: Day 1: Instil one drop every two hours in the affected eye(s) while awake, up to 8 times daily. Day 2 through 7: Instil one drop two to four times daily in the affected eye(s) while awake. No change in dosage is required for elderly patients. If you use ZYMAXID Soma hati kamili
ZYMAXID™ (gatifloxacin ophthalmic solution) 0.5% HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZYMAXID™ safely and effectively. See full prescribing information for ZYMAXID™. -------------------- ----------------- INDICATIONS AND USAGE ------------------------------------------ ZYMAXID™ ophthalmic solution is a topical fluoroquinolone anti -infective indicated for the treatment of patients 1 year of age or older with bacterial conjunctivitis caused b y susceptible strains of the following organisms: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, , Streptococcus mitis group*, Streptococcus oralis*, Streptococcus pneumoniae *Efficacy for this organism was studied in fewer th an 10 infections. (1) ------------------------------------- DOSAGE AND ADMINISTRATION --------------------------------- Patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Instill on e drop two to four times daily in the affected eye(s) while awake on Days 2 through 7. (2) ------------------------------------- DOSAGE FORMS AND STRENGTHS ------------------------------- Gatifloxacin ophthalmic solution 5.0 mg/mL. (3) ------------------- ------------------------- CONTRAINDICATIONS ----------------------------------------- Hypersensitivity to gatifloxacin, to other quinolones, or to any other ingredient in this product. (4) -------------------------------------- WARNINGS AND PRECAUTIONS ----- ----------------------------- • Topical Ophthalmic Use Only (5.1) • Growth of Resistant Organisms with Prolonged Use (5.2) • Avoidance of Contact Lenses. Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with ZYMAXID™ (5.3) --------------------------------------------- ADVERSE REACTIONS ---------------------------------------- Most common a dverse reactions occurring in ≥ 1 % of patients included eye irrit Soma hati kamili