Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
MOXIFLOXACIN HYDROCHLORIDE
Alcon Laboratories (UK) Ltd
S01AE07
MOXIFLOXACIN HYDROCHLORIDE
0.5 %w/v
Eye Drops Solution
Product subject to prescription which may not be renewed (A)
Fluoroquinolones
Authorised
2009-07-31
InDesign CS4 140 x 335 / 140 x 22 mm AANTAL KLEUREN : 1 MM 02-09- 2014 GBI RECTO - verso Moxivig 0.5 % 5 ml 64121 - 3 - DRAFT BELGIUM V1 PMS ZWART À 100 % - 20 % 64121 - 3 MOXIVIG * 0.5 % W / V EYE DROPS, SOLUTION Moxifloxacin hydrochloride PACKAGE LEAFLET : INFORMATION FOR THE USER MOXIVIG eye drops are used for the treatment of infections of the eye ( conjunctivitis ) when caused by bacteria. The active ingredient is moxifloxacin an ophthalmological anti-infective. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT’S IN THIS LEAFLET : 1. What MOXIVIG is and what it is used for 2. What you need to know before you use MOXIVIG 3. How to use MOXIVIG 4. Possible side effects 5. How to store MOXIVIG 6. Contents of the pack and other information DO NOT USE MOXIVIG • If you are allergic ( hypersensitive ) to moxifloxacin, to other quinolones, or any of the other ingredients of this medicine. WARNINGS AND PRECAUTIONS • IF YOU EXPERIENCE AN ALLERGIC REACTION TO MOXIVIG. Allergic reactions occur uncommonly and serious reactions occur rarely. If you experience any allergic ( hypersensitivity ) reaction or any side effect please refer to section 4. • IF YOU WEAR CONTACT LENSES – stop wearing your lenses if you have any signs or symptoms of an eye infection. Wear your glasses instead. Do not start wearing your lenses again until the signs and symptoms of the infec Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Moxivig 0.5% w/v eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 5.45 mg moxifloxacin hydrochloride equivalent to 5 mg moxifloxacin (0.5% w/v). Each eye drop contains 190 micrograms of moxifloxacin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution Clear, greenish -yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of purulent bacterial conjunctivitis, caused by moxifloxacin susceptible strains (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For ocular use only. Not for injection. MOXIVIG 0.5%w/v eye drops, solution should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. Use in adults including the elderly ( 65 years) The dose is one drop in the affected eye(s) 3 times a day. The infection normally improves within 5 days and treatment should then be continued for a further 2 -3 days. If no improvement is observed within 5 days of initiating therapy, the diagnosis and/or treatment should be reconsidered. The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection. Paediatric patients No dosage adjustment is necessary. Use in hepatic and renal impairment No dosage adjustment is necessary. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. In order to prevent the drops from being absorbed via the nasal mucosa, particularly in new-born infants or Belgenin tamamını okuyun