Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
IRON (III)
Vifor France
B03AB; B03AB02
IRON (III)
20 milligram(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Iron trivalent, oral preparations; saccharated iron oxide
Not marketed
2000-03-20
2021-12-13 PIL-VEN/MRP/E12 T IE01 1 / 7 PACKAGE LEAFLET: INFORMATION FOR THE USER VENOFER 20 MG IRON /ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION IRON SUCROSE 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Venofer is and what it is used for 2. What you need to know before Venofer is given to you 3. How Venofer is given 4. Possible side effects 5. How to store Venofer 6. Contents of the pack and other information 1. WHAT VENOFER IS AND WHAT IT IS USED FOR Venofer is a medicine that contains iron. Medicines that contain iron are used when you do not have enough iron in your body. This is called “iron deficiency”. Venofer is given when: - You cannot take iron by mouth - such as when iron tablets make you feel ill. - You have taken iron by mouth - and it has not worked. 2. WHAT YOU NEED TO KNOW BEFORE VENOFER IS GIVEN TO YOU YOU MUST NOT RECEIVE VENOFER IF: - You are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6). - You have experienced serious allergic (hypersensitive) reactions to other injectable iron preparations. - You have anaemia which is not caused by a shortage of iron. - You have too much iron in your body or a problem in the way your body uses iron. You must not be given Venofer if any of the above apply to you. If you are not sure, talk to your doctor before having Venofer. 2021-12-13 PIL-VEN/MRP/E12 T IE01 2 / 7 WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before receiving Venofer if: - You have a history of medicine allergy. - You have systemic lupus erythematosus. - You have rheumatoid arthritis. - You have severe asthma, eczema or other allergies. - You have any read_full_document
Health Products Regulatory Authority 22 March 2022 CRN00CRK4 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venofer 20 mg iron/mL solution for injection or concentrate for solution for infusion, ampoule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One millilitre of solution contains 20mg of iron as iron sucrose (iron(III)-hydroxide sucrose complex). Each 5 mL ampoule of Venofer contains 100 mg iron as iron sucrose (iron(III)-hydroxide sucrose complex). Excipient with known effect Venofer contains up to 7 mg sodium per mL. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or concentrate for solution for infusion. Venofer is a dark brown, non transparent, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Venofer is indicated for the treatment of iron deficiency in the following indications: - Where there is a clinical need for a rapid iron supply, - In patients who cannot tolerate oral iron therapy or who are non-compliant, - In active inflammatory bowel disease where oral iron preparations are ineffective, - In chronic kidney disease when oral iron preparations are less effective than Venofer. The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Hb, serum ferritin, TSAT, serum iron, etc.). (Hb haemoglobin, TSAT transferrin saturation). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Venofer. Venofer should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each Venofer administration (see section 4.4). Posology The cumulative dose of Venofer must be calculated for each patient individually and must not be exceeded. _Calculation of dosage_ The total cumulative dos read_full_document