Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Iron sucrose 540 mg/mL Equivalent to iron 20 mg/mL
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Iron sucrose 540 mg/mL (Equivalent to iron 20 mg/mL)
20 mg/mL
Solution for injection
Active: Iron sucrose 540 mg/mL Equivalent to iron 20 mg/mL Excipient: Water for injection
Ampoule, glass, 5mL, 5 dose units
Pharmacy only
Prescription
Vifor (International) Inc
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, · In active inflammatory bowel disease where oral iron preparations are ineffective.
Package - Contents - Shelf Life: Ampoule, glass, 5mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C
2002-12-20
2023-09-26_Venofer_AU_CMI 1 VENOFER® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING VENOFER? VENOFER provides a source of iron that can help to replenish a shortage of iron in patients with iron deficiency. For more information, see Section 1. Why am I using VENOFER? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE VENOFER? Do not use if you have ever had an allergic reaction to VENOFER or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use VENOFER? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines, such as iron tablets and VENOFER may interfere with each other. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE VENOFER? Your doctor or nurse will prepare this medicine for you. VENOFER is a sterile solution which is diluted immediately before use. It is given by intravenous infusion or by slow injection into the venous limb of the dialysis line for haemodialysis patients. More instructions can be found in Section 4. How do I use VENOFER? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING VENOFER? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using VENOFER. THINGS YOU SHOULD NOT DO • Do not take VENOFER if your anaemia is not due to shortage of iron. • Do not take VENOFER if you are in the first trimester of pregnancy. • Do not take VENOFER if you have a condition known as haemo-chromatosis (an excess of iron in the body) or a genetic tendency towards this condition. DRIVING OR USING MACHINES Be careful before you drive or use any machines or tools until you know how VENOFER affects you. DRINKING ALCOHOL Tell your docto Prečítajte si celý dokument
2023-11-03_Venofer_NZ_DS Page 1 of 12 NEW ZEALAND DATA SHEET 1. PRODUCT NAME VENOFER ® 20 mg/mL solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL ampoule contains 20 mg/mL iron as iron sucrose (iron(III) hydroxide sucrose complex) corresponding to 100 mg iron per ampoule. For the full list of excipients see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. VENOFER is a dark brown, non transparent, sterile aqueous solution of iron sucrose in water for injections with a pH of 10.5 - 11.0 and an osmolarity of 1,150 - 1,350 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, • In active inflammatory bowel disease where oral iron preparations are ineffective. Venofer should only be administered where the indication is confirmed by appropriate investigations (e.g. Hb, serum ferritin, serum iron). 4.2 DOSE AND METHOD OF ADMINISTRATION _DOSE _ 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 2023-11-03_Venofer_NZ_DS Page 2 of 12 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/L] X 0.24* + STORAGE IRON [MG] Below 35 kg BW: Target Hb = 130 g/L and storage iron = 15 mg/kg BW 35 kg BW and above: Target Hb = 150 g/L and storage iron = 500 mg * Factor 0.24 = 0.0034 (iron content of Hb = 0.34%) x 0.07 (blood volume = 7% of BW) x 1000 (conversion of [g] to [mg]) Total Venofer to be administered (in mL)= (Total iron deficit [mg]) (20 mg i Prečítajte si celý dokument