Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
Rowex Ltd Newtown Bantry, Co. Cork, , Ireland
B03AC
IRON 50 mg/ml
SOLUTION FOR INJECTION/INFUSION
IRON 50 mg/ml
POM
ANTIANEMIC PREPARATIONS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-11-17
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FERRIC CARBOXYMALTOSE 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 Ferric carboxymaltose is and what it is used for 2. What you need to know before you use Ferric carboxymaltose 3. How Ferric carboxymaltose is administered 4. Possible side effects 5. How to store Ferric carboxymaltose 6. Contents of the pack and other information 1. WHAT FERRIC CARBOXYMALTOSEIS AND WHAT IT IS USED FOR Ferric carboxymaltose 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. Ferric carboxymaltose 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 USE FERRIC CARBOXYMALTOSE YOU MUST NOT RECEIVE FERRIC CARBOXYMALTOSE • 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 Page 2 of 8 Talk to your doctor or nurse before receiving Ferric carboxymaltose: if you have a history of medicine allergy • if you have systemic lupus erythema Perskaitykite visą dokumentą
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT _ _ Ferric carboxymaltose 50 mg iron/mL dispersion for injection/infusion} 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of dispersion contains 50 mg of iron (as ferric carboxymaltose). Each 2 mL vial contains 100 mg of iron (as ferric carboxymaltose). Each 10 mL vial contains 500 mg of iron (as ferric carboxymaltose). Each 20 mL vial contains 1,000 mg of iron (as ferric carboxymaltose). Excipient(s) with known effect One mL of dispersion contains up to 5.9 mg (0.26 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 Ferric carboxymaltose} 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 Ferric carboxymaltose}. Ferric carboxymaltose} 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 Ferric carboxymaltose} administration (see section 4.4). Posology The posology of Ferric carboxymaltose} 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 _ Page 2 of 12 The individual iron need for repletion using Ferric carboxymaltose} is determined based on the p Perskaitykite visą dokumentą