Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Ferric carboxymaltose 180mg equivalent to iron 50mg
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Ferric carboxymaltose 180 mg (= iron 50mg)
50 mg/mL
Solution for injection
Active: Ferric carboxymaltose 180mg equivalent to iron 50mg Excipient: Hydrochloric acid Sodium hydroxide Water for injection
Vial, glass, Type I, bromobutyl rubber stopper and aluminium cap, 10 mL, 1 dose unit
Prescription
Prescription
Vifor (International) Inc
Indicated for the treatment of iron deficiency when oral iron preparations are ineffective, oral preparations cannot be used or there is a clinical need to deliver iron rapidly.
Package - Contents - Shelf Life: Vial, glass, Type I, bromobutyl rubber stopper and aluminium cap, 20 mL - 1 dose units - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate or freeze. - Vial, glass, Type I, bromobutyl rubber stopper and aluminium cap, 10 mL - 1 dose units - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate or freeze. - Vial, glass, Type I, bromobutyl rubber stopper and aluminium cap, 2 mL - 1 dose units - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate or freeze. - Vial, glass, Type I, bromobutyl rubber stopper and aluminium cap, 10 mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate or freeze. - Vial, glass, Type I, bromobutyl rubber stopper and aluminium cap, 2 mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate or freeze.
2011-09-27
Vifor Pharma Pty Ltd Version 09 1 FERINJECT _ _ FERRIC CARBOXYMALTOSE (FER-RIK CAR-BOXY-MALT-OSE) – SOLUTION FOR INJECTION CONSUMER MEDICINE INFORMATION _ _ 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 given 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 GIVEN FOR FERINJECT is given 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. It is also used when there is a clinical need to deliver iron rapidly. 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 FERINJECT _ - if you are hypersensitive (allergic) to ferric carboxymaltose or any of the other ingredients of FERINJECT, - if you have anaemia NOT caused by iron deficiency, - if you have iron overload (too much iron in your body) or disturbances in utilisation of iron. YOU MUST TELL YOUR DOCTOR IF - if you are under the age of 14 years. - you have an infection, asthma, eczemas, allergies or liver disorders. - you are pregnant or breastfe Lesen Sie das vollständige Dokument
Ferinject Datasheet NZ E14 Page 1 of 19 NEW ZEALAND DATA SHEET 1 PRODUCT NAME FERINJECT (ferric carboxymaltose) 50 mg/mL solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 mL vial contains 100 mg of iron as ferric carboxymaltose. Each 10 mL vial contains 500 mg of iron as ferric carboxymaltose. Each 20 mL vial contains 1000 mg of iron as ferric carboxymaltose. EXCIPIENT(S) WITH KNOWN EFFECT: Sodium hydroxide (for pH adjustment). For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. Chemical structure The active substance of FERINJECT is a complex of polynuclear iron(III)-hydroxide with 4(R)- (poly-(1 → 4)- _O_ - -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 1461680-64-7 3 PHARMACEUTICAL FORM Solution for injection. FERINJECT is a dark brown, non-transparent, colloidal solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FERINJECT is indicated for the treatment of iron deficiency when • oral iron preparations are ineffective • oral iron preparations cannot be used • there is a clinical need to deliver iron rapidly The diagnosis must be based on laboratory tests. Ferinject Datasheet NZ E14 Page 2 of 19 4.2 DOSE AND METHOD OF ADMINISTRATION DETERMINATION OF THE CUMULATIVE IRON DOSE The cumulative dose for repletion of iron using FERINJECT is determined based on the patient’s body weight and Hb level and must not be exceeded. There are two methods for determining the cumulative dose, the Ganzoni Method and the Simplified Method. Caution is recommended with the Simplified Method since it is based on experience in a single trial in adults with median Hb 104 g/L (range 61-146 g/L) and body weight ≥35 kg – See section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials Patients should be closely monitored whe Lesen Sie das vollständige Dokument