البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
Ferric carboxymaltose
Vifor Pharma Pty Ltd
Medicine Registered
CONSUMER MEDICINE INFORMATION FERINJECT ® WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FERINJECT. It does not contain all the available information. This does not replace talking with your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of using FERINJECT against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET. You may need to read it again. WHAT IS FERINJECT FERINJECT is an intravenous iron preparation, a medicine that is used in the treatment of iron deficiency conditions. It contains iron in the form of ferric carboxymaltose, an iron carbohydrate compound. Iron is an essential element required for the oxygen-carrying capacity of haemoglobin in red blood cells and of myoglobin in muscle tissue. Moreover, iron plays an important role in many other vital processes in the human body. WHAT FERINJECT IS USED FOR FERINJECT is used for the treatment of patients with iron deficiency, when oral iron preparations are ineffective or cannot be used. The aim of the therapy is to replenish body iron stores and to remedy anaemia, a reduced level of haemoglobin due to iron deficiency. Before administration, your doctor will perform a blood test to calculate the dose of FERINJECT you require. BEFORE YOU ARE GIVEN FERINJECT WHEN YOU MUST NOT BE GIVEN IT - if you are hypersensitive (allergic) to ferric carboxymaltose or any of the other ingredients of FERINJECT, - if you have ana اقرأ الوثيقة كاملة
FERINJECT PAGE 1/13 PRODUCT INFORMATION AU E07 PRODUCT INFORMATION FERINJECT ® NAME OF THE MEDICINE FERINJECT Ferric carboxymaltose Chemical structure The active substance of FERINJECT is a complex of polynuclear iron(III)-hydroxide with 4(R)-(poly-(1→4)-_O_-α-D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate. The relative molecular weight is approximately 150,000 Da, corresponding to the empirical formula: [FeO x (OH) y (H 2 O) z ] n [{(C 6 H 10 O 5 ) m (C 6 H 12 O 7 )} l ] k , where n ≈ 10 3 , m ≈ 8, l ≈ 11, and k ≈ 4. CAS-Number 9007-72-1 DESCRIPTION Solution for intravenous use. FERINJECT is a dark brown, non-transparent, colloidal solution. Excipients Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections PHARMACOLOGY Pharmacodynamic properties Ferric carboxymaltose (FCM) solution for injection/infusion contains iron in a stable ferric state as a complex with a carbohydrate polymer designed to provide iron for the iron transport and storage proteins in the body (transferrin and ferritin). FCM was effective in increasing haemoglobin (Hb) and serum ferritin concentrations in patients with mild to moderate iron-deficiency anaemia. The intravenous (IV) iron dose was 500 mg weekly for up to 4 weeks (n=20) or 1,000 mg weekly for up to 2 weeks (n=26). With the 500 mg iron dose, 37% of patients achieved normal Hb levels within 8 weeks and 75% achieved a ≥20 g/L increase in Hb on at least one occasion. With 1,000 mg iron, 48% of patients achieved normal Hb levels within 6 weeks and 73% achieved a اقرأ الوثيقة كاملة