País: Malta
Idioma: anglès
Font: Medicines Authority
CHROMIC CHLORIDE, COPPER CHLORIDE, FERRIC CHLORIDE, MANGANESE CHLORIDE, POTASSIUM IODIDE, SODIUM FLUORIDE, SODIUM MOLYBDATE, DIHYDRATE, SODIUM SELENITE, ZINC CHLORIDE
Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy
B05XA31
CHROMIC CHLORIDE 5.33 µg/ml COPPER CHLORIDE 0.102 mg/ml FERRIC CHLORIDE 0.54 mg/ml MANGANESE CHLORIDE 19.8 µg/ml POTASSIUM IODIDE 16.6 µg/ml SODIUM FLUORIDE 0.21 mg/ml SODIUM MOLYBDATE DIHYDRATE 4.85 µg/ml SODIUM SELENITE 17.3 µg/ml ZINC CHLORIDE 1.05 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
CHROMIC CHLORIDE 5.33 µg/ml COPPER CHLORIDE 0.102 mg/ml FERRIC CHLORIDE 0.54 mg/ml MANGANESE CHLORIDE 19.8 µg/ml POTASSIUM IODIDE 16.6 µg/ml SODIUM FLUORIDE 0.21 mg/ml SODIUM MOLYBDATE DIHYDRATE 4.85 µg/ml SODIUM SELENITE 17.3 µg/ml ZINC CHLORIDE 1.05 mg/ml
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2016-03-15
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ADDAVEN CONCENTRATE FOR SOLUTION FOR INFUSION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Addaven is and what it is used for 2. What you need to know before you receive Addaven 3. How you are given Addaven 4. Possible side effects 5. How to store Addaven 6. Contents of the pack and other information 1. WHAT ADDAVEN IS AND WHAT IT IS USED FOR Addaven is a medicine that contains trace elements. Trace elements are tiny amounts of chemicals that your body needs to work normally. Addaven is given intravenously (into a vein) when you can not eat normally. This medicine is usually used as part of a balanced intravenous diet, together with proteins, fat, carbohydrates, salts and vitamins. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ADDAVEN _ _ YOU SHOULD NOT RECEIVE ADDAVEN: - if you are allergic (hypersensitive) to any of the ingredients of this medicine (listed in section 6). IF YOU DEVELOP A RASH OR OTHER ALLERGIC REACTIONS (LIKE ITCHING, SWOLLEN LIPS OR FACE, OR SHORTNESS OF BREATH), INFORM YOUR DOCTOR IMMEDIATELY. - if your bile excretion is blocked; - if you have Wilson’s disease (a genetic disorder in which copper builds up in the body) or hemochromatosis (accumulation of iron in the body). Addaven must not be given to children less than 40 kg body weight WARNINGS AND PRECAUTIONS Talk to your doctor if you have problems with the way your liver and/or kidney work. Your doctor may want to do regular blood tests to check your condition. If you are taking iron orally in parallell with the infusion your doctor will check that iron is not accumulating in your body. Iron and iodine may cause allergic reactions on rare Llegiu el document complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Addaven concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ampoule of 10 ml contains: Chromic chloride hexahydrate 53.3 microgram Copper chloride dihydrate 1.02 milligram Ferric chloride hexahydrate 5.40 milligram Manganese chloride tetrahydrate 198 microgram Potassium iodide 166 microgram Sodium fluoride 2.10 milligram Sodium molybdate dihydrate 48.5 microgram Sodium selenite anhydrous 173 microgram Zinc chloride 10.5 milligram _The active ingredients in 10 ml of Addaven correspond to: _ _ _ Cr Cu Fe Mn 0.2 μmol 6 μmol 20 μmol 1 μmol 10 μg 380 μg 1.1 mg 55 μg I 1 μmol 130 μg F 50 μmol 950 μg Mo 0.2 μmol 19 μg (as Mo 6+) Se 1 μmol 79 μg (as Se 4+ ) Zn 77 μmol 5 mg _ _ _ _ The content of sodium and potassium in 10 ml corresponds to Sodium 1.0 mg 52 μmol Potassium 39 μg 1 μmol For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear solution, almost colourless. 2 • Osmolality: approx. 3100 mosm/kg water • pH: 2.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To meet basal to moderately increased requirements of trace elements in intravenous nutrition. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dosage is dependent on age, weight and any degree of deficiency of the patient and must be decided on an individual basis. _Adults_ : The recommended daily dosage of Addaven in adult patients with basal to moderately increased requirements is 10 ml (one ampoule). _Children: _ Addaven is not recommended for use in children weighing under 40 kg body weight. The trace element Peditrace should be used. Method of administration Addaven must not be given undiluted. For instructions on dilution of the medicinal product before administration, see section 6.6. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Conditions with total biliary obstruction - Wilson’s disease, he Llegiu el document complet