Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
FERROUS AS IRON III HYDROXIDE SUCROSE COMPLEX
CTS LTD
B03AC03
SOLUTION FOR INJECTION
FERROUS AS IRON III HYDROXIDE SUCROSE COMPLEX 100 MG / 5 ML
I.V
Required
VIFOR (INTERNATIONAL) INC, SWITZERLAND
IRON-SORBITOL-CITRIC ACID COMPLEX
IRON-SORBITOL-CITRIC ACID COMPLEX
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,• In chronic kidney disease when oral iron preparations are less effective.The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Hb, serum ferritin, TSAT, serum iron, etc.)(Hb haemoglobin, TSAT transferrin saturation)
2013-03-31
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only VENOFER SOLUTION FOR INJECTION 100 MG / 5ML THE ACTIVE INGREDIENT AND ITS CONCENTRATION: Each 5 ml of solution contains 100 mg of iron (as an iron III hydroxide sucrose complex) For a list of the inactive and allergenic ingredients in the preparation - see section 6 and the "Important information about some of the ingredients of the medicine" section. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? For 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 In chronic kidney disease when oral iron preparations are less effective The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g., haemoglobin, serum ferritin, TSAT (transferrin saturation), serum iron, etc.). THERAPEUTIC GROUP: Iron, preparations for the treatment of anaemia 2. BEFORE USING THE MEDICINE: X DO NOT USE THE MEDICINE IF: You are sensitive (allergic) to iron (FERROUS) or to any of the other ingredients contained in the medicine (see section 6). You have had a severe allergic reaction (hypersensitivity) to other injectable iron preparations. You have anaemia that is not caused by a shortage of iron. Your body has an excess of iron or improperly uses iron. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: ! BEFORE COMMENCING THE TREATMENT WITH VENOFER, INFORM THE DOCTOR IF YOU HAVE: Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT: Venofer, solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One millilitre of solution contains 20 mg of iron as iron sucrose (iron(III)-hydroxide sucrose complex). Each 5 ml ampoule of Venofer contains 100 mg iron as iron sucrose (iron(III)-hydroxide sucrose complex). Excipient with known effect Venofer contains up to 7 mg sodium per ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Venofer is a dark brown, non-transparent, aqueous solution. 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, • In chronic kidney disease when oral iron preparations are less effective. The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Hb, serum ferritin, TSAT, serum iron, etc.). (Hb haemoglobin, TSAT transferrin saturation) 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 administration (see section 4.4). Posology The cumulative dose of Venofer must be calculated for each patient individually and must not be exceeded. Calculation of dosage: 2 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 f Baca dokumen lengkap