Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
ferric carboxymaltose, Quantity: 3.6 g (Equivalent: iron, Qty 1000 mg)
Seqirus Pty Ltd
Injection, solution
Excipient Ingredients: hydrochloric acid; sodium hydroxide; water for injections
Intravenous
1 x 20 mL
(S4) Prescription Only Medicine
FERINJECT is indicated for the treatment of iron deficiency in adults and adolescents aged 14 years and older when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used ? there is a clinical need to deliver iron rapidly,The diagnosis of iron deficiency must be based on laboratory tests.,FERINJECT is indicated for the treatment of iron deficiency anaemia in children aged 1 to 13 years when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used,The diagnosis of iron deficiency anaemia must be based on laboratory tests.
Visual Identification: Dark brown, non-transparent, colloidal solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2018-06-05
Vifor Pharma Pty Ltd Version 10 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 Lire le document complet
210913 Ferinject Product Information Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION - FERINJECT ® (FERRIC CARBOXYMALTOSE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Ferric carboxymaltose 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. 3 PHARMACEUTICAL FORM Solution for intravenous use. 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. 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. 210913 Ferinject Product Information Page 2 of 18 Patients should be closely monitored when large single doses of FERINJECT (>200 mg iron) are administered since the safety data are limited. Post repletion, regular assessments should be done to ensure that iron levels are corrected and maintained. _Ganzoni Method _ Cumulative Iron Dose = Body Weight _kg_ x (Target Hb – Actual Hb _g/L_ ) x 0.24 + Iron Stores _mg_ where Target Hb = 130 g/L for body weight <35 kg and 150 g/L for bo Lire le document complet