Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AZITHROMYCIN DIHYDRATE
TRB CHEMEDICA MALAYSIA SDN BHD
AZITHROMYCIN DIHYDRATE
6 Units
Unimed Laboratories
AZYTER ® _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ Azithromycin dihydrate (15 mg/g) 1/2 WHAT IS IN THIS LEAFLET 1. What AZYTER is used for 2. How AZYTER works 3. Before you use AZYTER 4. How to use AZYTER 5. While you are using AZYTER 6. Side effects 7. Storage and Disposal of AZYTER 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT AZYTER IS USED FOR AZYTER (eye drops) is used for the local treatment of certain eye infections of bacterial origin in adults (including the elderly) and in children from birth to 17 years of age: purulent bacterial conjunctivitis, trachomatous conjunctivitis (particular ocular infection due to bacteria called _Chlamydia_ _trachomatis_ , found or occurring in some countries). HOW AZYTER WORKS AZYTER contains azithromycin, an antibiotic belonging to the macrolide class. BEFORE YOU USE AZYTER _When you must not use it_ Do not use AZYTER if you are allergic to azithromycin, to any other antibiotic from the macrolide class or to triglycerides, medium-chain. _Before you start to use it_ Talk to your doctor, or the doctor treating your child or your pharmacist or nurse before using AZYTER. This medicine is only intended for ocular use. Do not inject or swallow it. _Pregnancy:_ AZYTER can be used during pregnancy. Your doctor may prescribe this medicine for you while you are pregnant, if he/she considers it to be necessary. _Breast_ _feeding:_ Limited data indicate that azithromycin is excreted in breast milk, this medicine can be used during breast feeding. If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. _Taking other medicines_ If you are using any other eye medicine to be applied in the eye, you should: apply the other ophthalmic medicine, wait for 15 minutes, apply AZYTER last. Tell your doctor or the doctor treating your child or pharmacist if you are using or have recently use Baca dokumen lengkap
This printing proof represents exactly the way the PI will be printed. This means that by puting your signature on it, you fully accept its design, texts and that anything comply on a regulatory point of view to your local requirements. Name: Date: Signature: Your signature on this pdf means that you guarantee that technicals aspects of this PI comply with the size of the PI, the cutting shapes, the margins, the codes and their positions, the reserved areas, the varnished areas, the braille and all the embossed elements and all the necessary marks in order to ensure that the fi nished product will look at what is shown below. You should not modify this pdf. Name: Date: Signature: !! Customer approval !! !! Manufacturer approval !! Product: REG Safety AZYTER 6 UD Malaisie MAY-MSA - 1225U6MYS-2 - (ENG) PI Théa’s Code: N1225U6MYS-2/0119 Manufacturer: UNIMED PI Manufacturer’s Code: XXAZYXXX Type of PI: LEAFLET Dimensions (WH): 300 x 295 mm Remarks: Théa’s Template: GAB-UNED-N-300x295-0812-2 Fonts: Amœbia, Formata Title size: 18 pt Subtitle size: 12 pt Text size: 9 pt Interline size: 5 pt Code size: 7 pt Soft: InDesign (CC) Global version: 0119-5 Global version date: 2019-05-13 Customer version: 5 Customer version date: 2019-05-13 Technical version: 0 Technical version date: 2019-01-11 Black Black 67 % Black 35 % Used colours 3 PAGES Overscan Baca dokumen lengkap