מדינה: ארמניה
שפה: אנגלית
מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
tobramycin, dexamethasone
Rompharm Company SRL
S01CA01
tobramycin, dexamethasone
3mg/ml+ 1mg/ml
drops eye (suspension)
plastic vial 5ml
Prescription
Registered
2022-12-06
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE DRUG PRODUCT Dexatobrom 1 mg + 3 mg/ml eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre of suspension contains 1 mg dexamethasone and 3 mg tobramycin. Suspension pH: 5.0 - 6.0 Excipient with known effect: benzalkonium chloride 0.10 mg/ml For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension White or almost white suspension that may present a sediment which is readily redispersible by shaking. 4. CLINICAL DATA 4.1. THERAPEUTIC INDICATION Prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults and children aged 2 years and older. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Topical use. _Doses _ Use in adolescents and adults, including the elderly One or two drops are instilled into the conjunctival sac (s) of the affected eye (s) at intervals of 4-6 hours. In the first 24 to 48 hours of treatment, the dose may be increased to one or two drops given at 2-hour intervals. The frequency of administration should be gradually reduced as clinical signs improve. Treatment will not be stopped prematurely. In severe conditions, one or two drops should be given at one-hour intervals until the inflammation is under control, and then the frequency of administration should be gradually reduced to one or two drops at 2-hour intervals for 3 days; subsequently, one or two drops are administered at 4-hour intervals for 5 to 8 days, and finally, if deemed necessary, one or two drops per day for 5 to 8 days. After cataract surgery, the dose is one drop instilled 4 times a day, starting the following day after surgery, for up to 24 days. Treatment can be started one day before surgery, by administering a drop 4 times a day, continuing with a drop after surgery and then with a drop 4 2 times a day for up to 23 days. If deemed necessary, the frequency of administration may be increased to one drop administered at 2-hour intervals during the first two days of treat קרא את המסמך השלם