Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
FERRIC CARBOXYMALTOSE
CTS LTD
SOLUTION FOR INJECTION / INFUSION
FERRIC CARBOXYMALTOSE 1800 MG/VIAL
I.V
Required
VIFOR (INTERNATIONAL) INC, SWITZERLAND
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.
2016-06-30
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only FERINJECT SOLUTION FOR INJECTION/INFUSION 50 MG/ML THE ACTIVE INGREDIENT AND ITS CONCENTRATION: Each 10 ml of solution contains 500 mg iron (as 1800 mg ferric carboxymaltose) For a list of the inactive and allergenic ingredients in the preparation - see Section 6. 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 the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. The diagnosis must be based on laboratory tests. 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 ferric carboxymaltose 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. You have too much iron in your body or a problem in the way your body utilises iron.. ! SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE COMMENCING THE TREATMENT WITH FERINJECT, INFORM THE DOCTOR IF YOU HAVE: A history of sensitivity to medicines. Systemic lupus erythematosus. Rheumatoid arthritis. Severe asthma, eczema or other allergies. Any infections. Liver problems. Low levels of phosphate in the blood. Incorrect administration of Ferinject may cause leakage of the substance at the administration site, which may lead to skin irritation and even long-lasting skin discolouration at the administration si Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 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 180 mg ferric carboxymaltose. Each 10 mL vial contains 500 mg of iron as 1800 mg 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 the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion. Dark brown, non-transparent, aqueous solution inside a dark brown vial. 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 of iron deficiency 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 observed for adverse effects for at least 30 minutes following each Ferinject administration (see section 4.4). _ _ 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: _ _ _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: DETERMINATION OF THE IRON NEED HB PATIENT BODY WEIGHT G/DL MMOL/L BELOW 35 KG 35 KG TO <70 KG 70 KG AND ABOVE <10 <6.2 500 mg 1,500 mg 2,000 mg 10 to <14 6.2 to <8.7 500 mg 1,000 mg 1,500 mg >14 >8.7 50 Đọc toàn bộ tài liệu