国: マレーシア
言語: 英語
ソース: 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 完全なドキュメントを読む
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 完全なドキュメントを読む