Страна: Швеция
Език: шведски
Източник: Läkemedelsverket (Medical Products Agency)
levofloxacinhemihydrat
Actavis Group PTC ehf.
S01AE05
levofloxacin hemihydrate
5 mg/ml
Ögondroppar, lösning
bensalkoniumklorid Hjälpämne; levofloxacinhemihydrat 5,12 mg Aktiv substans
Receptbelagt
Förpacknings: Droppflaska, 5 ml
Godkänd
2016-03-17
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVOFLOXACIN ACTAVIS 5 MG/ML EYE DROPS, SOLUTION levofloxacin 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 /…/ is and what it is used for 2. What you need to know before you use /…/ 3. How to use /…/ 4. Possible side effects 5. How to store /…/ 6. Contents of the pack and other information 1. WHAT /…/ IS AND WHAT IT IS USED FOR Levofloxacin is an antibiotic of the type called fluoroquinolones (sometimes shortened to quinolones). It works by killing some types of bacteria that can cause infections. When levofloxacin is given in eye drops, it is used in children aged 1 year or over and in adults to treat bacterial infections that affect the front surfaces of the eye. One type of infection in this area is called bacterial conjunctivitis, which is an infection of the covering of the front of the eye (conjunctiva). /.../ is not recommended to be used in children aged below 1 year. You must talk to a doctor if you do not feel better or if you feel worse after 5 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE /…/ DO NOT USE /…/ - if you are allergic to levofloxacin or other quinolones or any of the other ingredients of this medicine (listed in section 6). If you are not sure, ask your doctor or pharmacist first. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using /…/ - if an allergic reaction occurs even after a single dose, stop using the medicine - if you observe worsening of your eye symptoms during treatment, please Прочетете целия документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levofloxacin Actavis 5 mg/ml eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of eye drops, solution, contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg of levofloxacin. Excipient with known effect: Each ml of eye drops, solution contains 0.05 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. Clear, pale yellow to pale greenish-yellow solution, practically free from visible particles. The pH of the solution is 6.0-6.8 and the osmolality is 270-320 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS /.../ 5 mg/ml eye drops are indicated for the topical treatment of bacterial external ocular infections in patients ≥1 year of age caused by levofloxacin susceptible microorganisms (see also sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. /.../ is indicated in adults, children aged ≥1 to 12 years and adolescents aged 12 to 18 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For all patients instil one to two drops in the affected eye(s) every two hours up to 8 times per day while awake for the first two days and then four times daily on days 3 through 5. If different topical ocular medications are used concomitantly, at least a 15-minute interval is required between instillations. To prevent contaminating the dropper tip and solution, the dropper tip should not come into contact with the eyelids or surrounding areas. The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection. The usual treatment duration is 5 days. Safety and efficacy in the treatment of corneal ulcer and ophthalmia neonatorum has not been established. 2 /.../ is not recommended for use in children below age 1 year due to a lack of data on safety and efficacy. _Use in the Elderly_ No adjustment of dosage is required. _Pa Прочетете целия документ