Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
IRON EQV IRON SUCROSE
VIFOR PHARMA ASIA PACIFIC PTE. LTD.
B03AC
100 mg/5 ml
INJECTION
IRON EQV IRON SUCROSE 100 mg/5 ml
INTRAVENOUS
Prescription Only
IDT Biologika GmbH
ACTIVE
2000-07-20
1. Trade Name of the Medicinal Product Venofer 2. Qualitative and Quantitative Composition Each 5 ml ampoule contains 20 mg/ml iron as iron sucrose corresponding to 100 mg iron per ampoule. 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 with a pH of 10.5 – 11.0 and an osmolarity of 1250 mOsmol/l. 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 Where oral iron preparations are ineffective (e.g., in active inflammatory bowel disease) Venofer should only be administered where the indication is confirmed by appropriate investigations. 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 immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each Venofer injection. Posology The cumulative dose of Venofer must be calculated for each patient individually and must not be exceeded. Calculation of dosage The total cumulative dose of Venofer, equivalent to the total iron deficit (mg), is determined by the haemoglobin level (Hb) and body weight (BW). The dose of Venofer must be individually calculated for each patient according to the total iron deficit calculated with the following Ganzoni formula, for example: Total iron deficit [mg] = BW [kg] x (target Hb - actual Hb) [g/dl] x 2.4* + storage iron [mg] Below 35 kg BW: Target Hb = 13 g/dl and storage iron = 15 mg/kg BW 35 kg BW and above: Target Hb = 15 Đọc toàn bộ tài liệu