Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Clarithromycin
Martindale Pharmaceuticals Ltd
J01FA; J01FA09
Clarithromycin
500 milligram(s)
Pdr/Conc/Soln for Infus
Product subject to prescription which may not be renewed (A)
Macrolides; clarithromycin
Not marketed
2009-10-16
PACKAGE LEAFLET: INFORMATION FOR THE USER CLARITHROMYCIN 500MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Clarithromycin 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. - 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. This medicine will be referred to as Clarithromycin in the rest of this leaflet WHAT IS IN THIS LEAFLET: 1. What Clarithromycin is and what it is used for 2. What you need to know before you are given Clarithromycin 3. How Clarithromycin will be given 4. Possible side effects 5. How to store Clarithromycin 6. Contents of the pack and other information 1. WHAT CLARITHROMYCIN IS AND WHAT IT IS USED FOR Clarithromycin contains the active substance clarithromycin, which belongs to a group of medicines called ‘macrolide antibiotics’. These are used to kill bacteria or ‘germs’ that cause infections. Clarithromycin is used whenever an intravenous (injection into a vein) antibiotic is required to treat severe infections or alternatively if a patient is unable to swallow clarithromycin tablets. It is used to treat infections such as Chest infections such as bronchitis and pneumonia throat and sinus infections skin and tissue infections caused by bacteria. Clarithromycin is for use in adults and children 12 years and older. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CLARITHROMYCIN YOU SHOULD NOT BE GIVEN CLARITHROMYCIN: if you are allergic to clarithromycin or other macrolide antibiotics such as erythromycin or azithromycin or to any of the other ingredients of this medicine, (listed in section 6) if you are taking ergotamine or dihydroergotamine tablets or ergotamine inhalers (used to treat migraine if you are taking oral midazolam (a sedative) if you are taking terfenadine Perskaitykite visą dokumentą
Health Products Regulatory Authority 13 December 2019 CRN008L8W Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarithromycin Martindale Pharma 500 mg Powder for Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg clarithromycin as clarithromycin lactobionate. When reconstituted and diluted, the final diluted solution contains approximately 2 mg/ml of clarithromycin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for Concentrate for Solution for Infusion A white to off-white caked powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin is indicated when parenteral therapy is required for treatment of infections caused by susceptible organisms in the following conditions (see sections 4.4 and 5.1); - Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia (see section 4.4 and 5.1 regarding Sensitivity Testing).- Upper respiratory tract infections for example, sinusitis, pharyngitis and tonsilitis.Skin and soft tissue infections (e.g. folliculitis, cellulitis, erysipelas) (see section 4.4 and 5.1 regarding Sensitivity Testing). Consideration should be given to official guidance in the appropriate use of antibacterial agents. Clarithromycin is indicated in adults and children 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Intravenous therapy may be given for 2 to 5 days and should be changed to oral clarithromycin therapy whenever possible as determined by the physician.. The total duration of treatment should not exceed more than 14 days. The usual duration of treatment is 6 to 14 days. Adults: The recommended dosage of Clarithromycin is 1gram daily, divided into two 500 mg doses, appropriately diluted (see section 6.6). Paediatric population Children older than 12 years: As for adults. Children younger than 12 years: Use of clarithromycin IV is not recommended for children younger than 12 years. Use clarithromycin P Perskaitykite visą dokumentą