מדינה: הולנד
שפה: הולנדית
מקור: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
OFLOXACINE 3 mg/ml
Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)
S01AE01
OFLOXACINE 3 mg/ml
Oogdruppels, oplossing
NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),
Oculair gebruik
Ofloxacin
Hulpstoffen: NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); WATER, GEZUIVERD; ZOUTZUUR (E 507);
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER OFLOXACINE DEVATIS 3 MG/ML, OOGDRUPPELS, OPLOSSING, VERPAKKING VOOR ÉÉNMALIG GEBRUIK Ofloxacin 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 signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ofloxacine Devatis is and what it is used for 2. What you need to know before you use Ofloxacine Devatis 3. How to use Ofloxacine Devatis 4. Possible side effects 5. How to store Ofloxacine Devatis 6. Contents of the pack and other information 1. WHAT OFLOXACINE DEVATIS IS AND WHAT IT IS USED FOR Ofloxacine Devatis is an eye drop to treat external eye infections such as bacterial conjunctivitis (inflammation of the conjunctiva) and keratitis (inflammation of the cornea) in adults and children caused by ofloxacin-sensitive organisms. Ofloxacin is an antibacterial agent and belongs to a group of medicines called fluoroquinolones (sometimes shortened to quinolones). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OFLOXACINE DEVATIS DO NOT TAKE: - If you are allergic (hypersensitive) to ofloxacin, to any other quinolones (the group of this medicine) or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Ofloxacine Devatis. - if you are sensitive to other quinolone antibacterial agents - if you suffer from defects or ulcers of the ocular surface. Long term use may result in a new bacterial infection which does not respond to Ofloxacine Devatis. Tendon swelling and rupture have happened in people taking oral or intravenous fluoroquinolones קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Ofloxacine Devatis 3 mg/ml, oogdruppels, oplossing, Verpakking voor éénmalig gebruik 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 3 mg ofloxacin in a preservative free formulation. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FROM Eye drop solution in single-dose container for administration by instillation in the conjunctival sac. Clear, pale light yellow solution, free from visible particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ofloxacine Devatis is indicated for the topical treatment of external ocular infections (such as conjunctivitis and keratitis) in adults and children caused by ofloxacin - sensitive organisms. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ocular use POSOLOGY Instillation of one drop of Ofloxacine Devatis in the conjunctival sac of the affected eye(s) every two to four hours for the first two days, followed by four times daily. The length of treatment should not exceed 14 days. _Paediatric population _ No dose adjustment is necessary. _ _ _Elderly population _ No dose adjustment is necessary (see section 4.4). METHOD OF ADMINISTRATION Patients should be instructed to avoid contact between the tip of the SINGLE-DOSE container and the eyes or areas around the eyes. The solution from one individual single-dose container of Ofloxacine Devatis is to be used immediately after opening since sterility cannot be maintained after the individual single-dose container is opened. If another topical agent is being used, Ofloxacine Devatis and the other agent should be administered at least 15 minutes apart. Eye ointments should always be applied at last. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance, any other quinolones or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Safety and effectiveness in infants below the age of one קרא את המסמך השלם