Země: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
FERRIC CARBOXYMALTOSE 180 mg EQV IRON
VIFOR PHARMA ASIA PACIFIC PTE. LTD.
B03AC01
50mg
INJECTION, SOLUTION
FERRIC CARBOXYMALTOSE 180 mg EQV IRON 50 mg/ml
INTRAVENOUS DRIP, INTRAVENOUS BOLUS
Prescription Only
IDT Biologika GmbH
ACTIVE
2011-10-19
FERINJECT ® 1. NAME OF THE MEDICINAL PRODUCT Ferinject 50 mg iron/ml solution for injection/infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains 50 mg of iron as ferric carboxymaltose. Each 2 ml vial contains 100 mg of iron as ferric carboxymaltose. Each 10 ml vial contains 500 mg of iron as ferric carboxymaltose. One ml of solution contains up to 5.5 mg (0.24 mmol) sodium, see section 4.4. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion. Dark brown, non-transparent, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ferinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. The diagnosis must be based on laboratory tests. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Ferinject. Ferinject 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 closely observed for signs and sympotms of hypersensitivity reactions during and for at least 30 minutes following each Ferinject injection. _ _ _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 haemoglobin level and must not be exceeded. The following table should be used to determine the cumulative iron dose: 140808 SPC-YV007/YV080/SG/E05 Vifor (International) Inc Page 1/9 Hb (g/dL) Patients with body weight 35 kg Přečtěte si celý dokument
Vifor (International) Inc Page 1/11 BUSINESS USE FERINJECT ® 1. NAME OF THE MEDICINAL PRODUCT Ferinject 50 mg iron/ml solution for injection/infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains 50 mg of iron as ferric carboxymaltose. Each 2 ml vial contains 100 mg of iron as ferric carboxymaltose. Each 10 ml vial contains 500 mg of iron as ferric carboxymaltose. Excipient(s) with known effect One ml of solution contains up to 5.5 mg (0.24 mmol) sodium, see section 4.4. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion. Dark brown, non-transparent, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ferinject is indicated for the treatment of iron deficiency when (see section 5.1) -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 POSOLOGY AND METHOD OF ADMINISTRATION Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Ferinject. Ferinject 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 closely observed for signs and sympotms of hypersensitivity reactions during and for at least 30 minutes following each Ferinject administration . _ _ Posology The posology of Ferinject follows a stepwise approach: [1] determination of the individual iron need, [2] calculation and administration of the iron dose(s), and [3] post-iron repletion assessments. These steps are outlined below: Vifor (International) Inc Page 2/11 BUSINESS USE _Step 1: Determination of the iron need_ The individual iron need for repletion using Ferinject is determined based on the patient’s body weight and haemoglobin (Hb) level. Refer to Table 1 for determination of the iron need: TABLE 1: DET Přečtěte si celý dokument