Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Erythromycin
Amdipharm Limited
J01FA; J01FA01
Erythromycin
1 gram(s)
Powder for concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Macrolides; erythromycin
Marketed
1980-01-28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ERYTHROCIN ® IV LACTOBIONATE 1 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION (ERYTHROMYCIN LACTOBIONATE)_ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or nurse. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Erythrocin IV Lactobionate 1 g Powder for Concentrate for Solution for Infusion (will be referred to Erythrocin IV Lactobionate throughout this leaflet). WHAT IS IN THIS LEAFLET 1. What Erythrocin IV Lactobionate is and what it is used for 2. What you need to know before you are given Erythrocin IV Lactobionate 3. How Erythrocin IV Lactobionate will be given to you 4. Possible side effects 5. How to store Erythrocin IV Lactobionate 6. Contents of the pack and other information 1. WHAT ERYTHROCIN IV LACTOBIONATE IS AND WHAT IT IS USED FOR Erythrocin IV Lactobionate belongs to a group of drugs called antibiotics, and is used in adults and children to treat infections which are caused by bacteria. Erythrocin IV Lactobionate may be used if you cannot swallow erythromycin tablets or are at particular risk of developing an infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ERYTHROCIN IV LACTOBIONATE DO NOT BE GIVEN ERYTHROCIN IV LACTOBIONATE: • If you are allergic to erythromycin or any of the other ingredients of this medicine (listed in section 6). • If you are allergic to macrolide antibiotics such as clarithromycin or azithromycin. • If you are currently taking a medicine called - ergotamine or dihydroergotamine (used to treat migraines) while taking erythromycin as this may cause serious side effects; - terfenadine or astemizole (widely taken for hayfever and allergies), cisapride (for stomach disorders) or pimozide ( Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 27 March 2023 CRN00DG0D Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Erythrocin IV Lactobionate 1 g Powder for Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains erythromycin lactobionate equivalent to 1 g of erythromycin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (Powder for sterile concentrate). A white to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Erythrocin IV Lactobionate is indicated in adults and children for the prophylaxis and treatment of infections caused by erythromycin sensitive organisms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults, children and neonates: Severe and immunocompromised infections; 50 mg/kg/day, preferably by continuous infusion, (equivalent to 4g per day for adults). Mild to moderate infections (oral route compromised); 25 mg/kg/day. Elderly: No special dosage recommendations. Hepatic impairment Erythromycin should be used with caution in patients with impaired hepatic function (see sections 4.4 & 5.2). Method of administration BOLUS INJECTION (IV PUSH) IS CONTRAINDICATED Continuous infusion of erythromycin lactobionate is preferred due to the slower infusion rate and lower concentration of erythromycin; however, intermittent infusion at intervals not greater than every six hours is also effective. Erythromycin lactobionate must be administered by continuous or intermittent intravenous infusion only. Intravenous erythromycin should be replaced by oral erythromycin as soon as possible. PREPARATIONS FOR ADMINISTRATION: For Intermittent Infusion of 1 gram dose: Step 1 - add 20 ml of Water for Injections BP to the 1 g vial. Step 2 - add 20 ml of Step 1 solution to 200-250 ml of Sodium Chloride Intravenous Infusion BP (0.9% Saline). This provides a 0.5%-0.4% solution. Health Products Regulatory Authority 27 March 2023 CRN00DG0D Page 2 of 9 If it is decide Կարդացեք ամբողջական փաստաթուղթը