البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DEXAMETHASONE SODIUM PHOSPHATE; GENTAMICIN SULPHATE
PHARMAFORTE (MALAYSIA) SDN. BHD.
DEXAMETHASONE SODIUM PHOSPHATE; GENTAMICIN SULPHATE
5ml mL
Ursapharm Arzneimittel GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ DEXA-GENTAMICIN EYE DROPS _ _ Dexamethasone Phosphate/ Gentamicin Sulphate (1mg/5mg per 1ml) 1 WHAT IS IN THIS LEAFLET 1. What Dexa-Gentamicin is used for 2. How Dexa-Gentamicin works 3. Before you use Dexa-Gentamicin 4. How to use Dexa-Gentamicin 5. While you are using it 6. Side effects 7.Storage and Disposal of Dexa- Gentamicin 8. Product Description 9.Manufacturer and Product Registration Holder 10. Date of revision WHAT DEXA-GENTAMICIN IS USED FOR Dexa-Gentamicin is used for bacterial infections associated with allergic reaction or inflammation of the eyes or eyelids. HOW DEXA-GENTAMICIN WORKS Dexa-Gentamicin contains active ingredients of dexamethasone and gentamicin. Dexamethasone is in corticosteroid group which help to reduce inflammation, redness and itchiness, while gentamicin is an antibiotic that kills certain bacteria that caused infections. BEFORE YOU USE DEXA-GENTAMICIN _- When you must not use it _ Do not use Dexa-Gentamicin if: • you are allergic to dexamethasone, gentamicin sulphate or any ingredients of this medicine (listed in Product Description) • you have viral, tuberculous or fungal infection or ulceration of the eyes • you have increased pressure in the eyes (glaucoma) Consult your doctor before using Dexa-Gentamicin. _- Before you start to use it _ Please tell your doctor if you have any medical illness. Not to be used in children below 8 years old. _Pregnancy and lactation _ Please consult your doctor or pharmacist if you are pregnant, planning for pregnancy or breast- feeding before using any medicine. Dexa-Gentamicin must only be used during pregnancy if the benefits is more than the risks to the fetus. Dexamethasone is secreted into breast milk and may affect your baby. Your doctor will discuss the risk and benefits of breast feeding while you’re using Dexa-Gentamicin. _- Taking other medicines _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supe اقرأ الوثيقة كاملة
DEXA-GENTAMICIN™ EYE DROPS DEXAMETHASONE SODIUM PHOSPHATE 1.00 MG/ML AND GENTAMICIN SULPHATE 5.00 MG/ML ANTIALLERGIC, ANTI-INFLAMMATORY AND ANTI-INFECTIVE AGENT PRODUCT DESCRIPTION Dexa-Gentamicin™ eye drops (1.0 mg/ml Dexamethasone sodium phosphate and 5.0 mg/ml Gentamicin sulphate) is a clear, colourless solution available as 5 ml solution filled in plastic bottles with dropping inserts and caps. PHARMACOLOGY PHARMACODYNAMICS _ANTIBIOTIC_ The bactericidal action of Gentamicin is based on an irreversible inhibition of the bacterial protein synthesis. Gentamicin elicits rapid bacterial action by acting directly on the bacterial ribosome, where it disrupts the normal cycle of ribosomal function. Additionally, Gentamicin includes misreading of the genetic code of the mRNA template, leading to incorporation of incorrect amino acids into the growing polypeptide chain. _CORTICOSTEROID_ The corticosteroid’s method of action is not yet completely known. The corticosteroids are thought to act by controlling the rate of synthesis of proteins important for chemotactic and immunologic reactions. Modifications of the leukocyte’s and macrophage’s functions seem to have an influence on the suppression of inflammatory and allergic reactions. PHARMACOKINETICS _ANTIBIOTIC_ Systemically available Gentamicin has a half-life of plasma of 2 to 3 hours in healthy adults and is excreted unchanged by the kidneys. Topically applied, Gentamicin is absorbed by conjunctiva and cornea and is detectable in the aqueous humour 15 minutes after application. Using Gentamicin on intact mucous membranes of the eye, no detectable amounts of Gentamicin are to be expected in serum. _CORTICOSTEROID_ Dexamethasone sodium phosphate and Dexamethasone poorly penetrate an intact corneal epithelium. The penetration is significantly elevated in eyes with inflamed or lesioned mucosal membranes. Systemically absorbed Dexamethasone is bound to proteins to 80 %. It is excreted by the kidneys (as glucuronid) with a half-life of 3 to 4 hours. INDICATIONS اقرأ الوثيقة كاملة