Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Azithromycin dihydrate
Laboratoires Thea
S01AA; S01AA26
Azithromycin dihydrate
15 milligram(s)/gram
Eye drops, solution
Product subject to prescription which may not be renewed (A)
Antibiotics; azithromycin
Marketed
2011-05-20
Package Leaflet: Information for the patient AZYTER 15 MG/G, EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINER Azithromycin dihydrate 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 the doctor treating your child, or pharmacist or nurse. - This medicine has been prescribed for you or for your child 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. What is in this leaflet: 1. What AZYTER is and what it is used for 2. What you need to know before you use AZYTER 3. How to use AZYTER 4. Possible side effects 5. How to store AZYTER 6. Contents of the pack and other information 1. WHAT AZYTER IS AND WHAT IT IS USED FOR Azyter contains azithromycin, which is an antibiotic (macrolide class). Azyter is used to treat some eye infections that are caused by bacteria in adults (including the elderly) and in children from birth to 17 years of age. • purulent bacterial conjunctivitis, • trachoma conjunctivitis (a particular infection of the eye caused by bacteria called _Chlamydia trachomatis_ , which is usually found in developing countries). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AZYTER DO NOT USE AZYTER: - If you are allergic to azithromycin, to any other antibiotic from the macrolide class or to medium-chain triglycerides. WARNINGS AND PRECAUTIONS Talk to your doctor, or the doctor treating your child, or your pharmacist or nurse before using Azyter - If you or your child have an allergic reaction, stop the treatment and tell your doctor or the doctor treating your child. - If you or your child’s eye infection does not get better after three days using the drops, or if you notice anything unusual, tell your doctor or the doctor treating your child Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 17 January 2019 CRN008TNK Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azyter 15 mg/g eye drops, solution, in single-dose container 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of solution contains 15 mg of azithromycin dihydrate equivalent to 14.3 mg of azithromycin. One single-dose container of 250 mg solution contains 3.75 milligrams of azithromycin dihydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution in single-dose container. Clear, colourless to slightly yellow, oily liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AZYTER 15 mg/g, eye drops, solution in single-dose container is indicated for the local antibacterial curative treatment of conjunctivitis caused by susceptible strains (see sections 4.4 and 5.1): - Purulent bacterial conjunctivitis in children (aged from birth to 17 years) and adults, - Trachomatous conjunctivitis caused by _Chlamydia trachomatis_ in children (aged from birth to 17 years) and adults (see section 4.4 “Use in neonates”). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ Adult population Instil one drop in the conjunctival fornix twice a day, morning and evening, during three days. It is unnecessary to prolong treatment beyond three days. Adherence to the dosing regimen is important for the success of treatment. Health Products Regulatory Authority 17 January 2019 CRN008TNK Page 2 of 11 Elderly patients: No dose adjustment is necessary. Paediatric population No dose adjustment is necessary (see section 4.4 and 5.1). _Method of administration_ Ocular use. The patient should be advised to: - thoroughly wash hands before and after the instillation, - avoid touching the eye or eyelids with the dropper tip of the single-dose container, - discard the single-dose container after use, and not keep it for subsequent use. 4.3 CONTRAINDICATIONS Hyperse Olvassa el a teljes dokumentumot