Country: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Iron sucrose
Vifor Pharma UK Ltd
Iron sucrose
20mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 09010102; GTIN: 7640114720307
PACKAGE LEAFLET: INFORMATION FOR THE USER VENOFER 20 MG IRON /ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION IRON SUCROSE This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before receiving Venofer if: - You have a history of medicine al সম্পূর্ণ নথি পড়ুন
OBJECT 1 VENOFER (IRON SUCROSE) Summary of Product Characteristics Updated 09-Nov-2016 | Vifor Pharma UK Limited This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Venofer 20 mg iron / ml, solution for injection or concentrate for solution for infusion. 2. Qualitative and quantitative composition One millilitre of solution contains 20 mg 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). Each 2.5 ml vial of Venofer contains 50 mg iron as iron sucrose (iron(III)-hydroxide sucrose complex). Each 5 ml vial of Venofer contains 100 mg iron as iron sucrose (iron(III)-hydroxide sucrose complex). 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. 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 সম্পূর্ণ নথি পড়ুন