Država: Švedska
Jezik: švedščina
Source: Läkemedelsverket (Medical Products Agency)
järn(III)karboximaltos
Cross Pharma AB
B03AC
iron (III) karboximaltos
50 mg Fe/ml
Injektions-/infusionsvätska, lösning
järn(III)karboximaltos 180 mg Aktiv substans
Apotek
Receptbelagt
parenterala preparat
Avregistrerad
2014-09-10
1/8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FERINJECT 50 MG IRON/ML DISPERSION FOR INJECTION/INFUSION Ferric carboxymaltose READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ferinject is and what it is used for 2. What you need to know before you receive Ferinject 3. How Ferinject is administered 4. Possible side effects 5. How to store Ferinject 6. Contents of the pack and other information 1. WHAT FERINJECT IS AND WHAT IT IS USED FOR Ferinject is a medicine that contains iron. Medicines that contain iron are used when you do not have enough iron in your body. This is called iron deficiency. Ferinject is used to treat iron deficiency when: - oral iron is not effective enough. - you cannot tolerate oral iron. - your doctor decides you need iron very quickly to build up your iron stores. The doctor will determine whether you have iron deficiency by performing a blood test. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FERINJECT YOU MUST NOT RECEIVE FERINJECT - if you are allergic (hypersensitive) to ferric carboxymaltose or any of the other ingredients of this medicine (listed in section 6). - if you have experienced serious allergic (hypersensitive) reactions to other injectable iron preparations. - if you have anaemia NOT caused by iron deficiency. - if you have an iron overload (too much iron in your body) or disturbances in the utilisation of iron. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before receiving Ferinject: - if you have a history of medicine allergy. - if you have systemic lupus erythematosus. - if you have rheumatoid arthritis. - if you have severe asthma, eczema or other allergies. - if you have an infection. - if you have liver disorders. - if Preberite celoten dokument
1/13 1. NAME OF THE MEDICINAL PRODUCT Ferinject 50 mg iron/mL dispersion for injection/infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of dispersion contains ferric carboxymaltose corresponding to 50 mg iron. Each 2 mL vial contains ferric carboxymaltose corresponding to 100 mg iron. Each 10 mL vial contains ferric carboxymaltose corresponding to 500 mg iron. Each 20 mL vial contains ferric carboxymaltose corresponding to 1,000 mg iron. Excipient(s) with known effect One mL of dispersion 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 Dispersion for injection/infusion. Dark brown, non-transparent, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ferinject is indicated for the treatment of iron deficiency when (see section 5.1): - oral iron preparations are ineffective. - oral iron preparations cannot be used. - there is a clinical need to deliver iron rapidly. 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. 2/13 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 total iron need. 2 Preberite celoten dokument