Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
iron sucrose, Quantity: 540 mg/mL (Equivalent: iron, Qty 20 mg/mL)
Seqirus Pty Ltd
Injection, concentrated
Excipient Ingredients: sodium hydroxide; water for injections
Intravenous
5 x 5mL ampoules
(S4) Prescription Only Medicine
VENOFER is indicated for the treatment of iron deficiency anaemia in patients undergoing chronic haemodialysis and who are receiving supplemental erythropoietin therapy.,The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. serum ferritin, serum iron, transferrin saturation and hypochromic red cells).
Visual Identification: Dark brown, non-transparent aqueous solution contained in a 5 mL glass ampoule.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2004-05-19
Venofer Consumer Medicine Information v06 VENOFER ® _ _ _iron sucrose _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VENOFER. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you being given VENOFER against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING VENOFER ASK YOUR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT VENOFER IS USED FOR VENOFER provides a source of iron that can help to replenish a shortage of iron in patients with iron deficiency. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY VENOFER HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor's prescription. There is no evidence that it is addictive. BEFORE YOU ARE GIVEN VENOFER _ _ _ _ _When you must not be _ _given it _ YOU MUST NOT BE GIVEN VENOFER IF: • you are known to be sensitive to any of the ingredients of this medicine listed at the end of this leaflet • your anaemia is not due to a shortage of iron • you are in the first trimester of a pregnancy • you have a condition known as haemo- chromatosis (an excess of iron in the body) or a genetic tendency towards this condition. VENOFER should not be used after the expiry date printed on the label. IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN VENOFER, TALK TO YOUR DOCTOR. _Before you are given it _ _ _ YOU SHOULD BE AWARE THAT: • a blood test should have been carried out to ensure treatment with this medicine is appropriate • if you have a history of asthma, eczema or other atopic allergies you are more susceptible to experience allergic reactions • intravenous iron preparations can cause severe allergic reactions. These allergic reactions may include chest pain. Tell your doctor immediately if you experience it. TELL YOUR DOCTOR IF YOU Prečítajte si celý dokument
20210825 - SPC-YA539/AU/E07 Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION - VENOFER (IRON SUCROSE) 1 NAME OF THE MEDICINE Iron sucrose 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each VENOFER 5 mL ampoule contains 20 mg/mL iron as iron sucrose (iron(III) hydroxide sucrose complex) as the active ingredient corresponding to 100 mg iron per 5 mL ampoule. For the full list of excipients see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Concentrated injection for intravenous use. 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 anaemia in patients undergoing chronic haemodialysis and who are receiving supplemental erythropoietin therapy. The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. serum ferritin, serum iron, transferrin saturation and hypochromic red cells). 4.2 DOSAGE AND METHOD OF ADMINISTRATION The dosage of VENOFER is expressed in terms of mg of iron. Each mL contains 20 mg of iron. Since a test dose without incident does not indicate that subsequent doses will also be reaction free, test doses may still be carried out but are not required. 20210825 - SPC-YA539/AU/E07 Page 2 of 12 TREATMENT OF IRON DEFICIENCY IN HAEMODIALYSIS PATIENTS RECEIVING ERYTHROPOIETIN: The recommended dosage of VENOFER for the treatment of iron deficiency in haemodialysis patients receiving erythropoietin therapy is 100 mg of iron (5 mL of VENOFER) delivered intravenously during the dialysis session. Frequency of dosing should not be more than three times per week. Most patients will require a minimum cumulative dose of 1000 mg of iron, administered over 10 sequential dialysis sessions, to achieve a favourable haemoglobin or haematocrit response. Patients may continue to require therapy with VENOFER at the lowest dose necessary to maintain target levels of haemoglobin, haematocrit and laboratory parameters of iron sto Prečítajte si celý dokument