Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
FERRIC CHLORIDE HEXAHYDRATE ; ZINC CHLORIDE ; MANGANESE CHLORIDE TETRAHYDRATE ; CUPRIC CHLORIDE DIHYDRATE ; POTASSIUM IODIDE ; CHROMIUM TRICHLORIDE HEXAHYDRATE; SODIUM SELENITE ; SODIUM MOLYBDATE DIHYDRATE ; SODIUM FLUORIDE
Fresenius Kabi Limited
B05XA31
FERRIC CHLORIDE HEXAHYDRATE ; ZINC CHLORIDE ; MANGANESE CHLORIDE TETRAHYDRATE ; CUPRIC CHLORIDE DIHYDRATE ; POTASSIUM IODIDE ; CHROMIUM TRICHLORIDE HEXAHYDRATE; SODIUM SELENITE ; SODIUM MOLYBDATE DIHYDRATE ; SODIUM FLUORIDE
10 Millilitre
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
electrolytes in combination with other drugs
Marketed
1988-05-16
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, pharmacist or nurse. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Additrace ® is and what it is used for 2. What you need to know before you use Additrace ® 3. How to use Additrace ® 4. Possible side effects 5. How to store Additrace ® 6. Contents of the pack and other information 1. WHAT ADDITRACE ® IS AND WHAT IT IS USED FOR Additrace ® provides trace elements into your blood stream when you cannot eat normally. Trace elements are tiny amounts of chemicals that your body needs to work normally. Additrace ® 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 USE ADDITRACE ® DO NOT USE ADDITRACE ® : • if you are allergic to any of the ingredients of Additrace ® mentioned in section 6. IF YOU DEVELOP A RASH OR OTHER ALLERGIC REACTIONS (LIKE ITCHING, SWOLLEN LIPS OR FACE OR SHORTNESS OF BREATH), PLEASE INFORM YOUR DOCTOR. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Additrace ® if you suffer from: - impaired liver and/or kidney function Your doctor may want to do regular blood tests to check your condition. Additrace ® MUST BE DILUTED BEFORE USE. It will be added to another solution before it is given to you. Your doctor, pharmacist or nurse will make sure it is prepared correctly before you receive Additrace ® . Additrace ® should not be used if the solution is cloudy or contains particles. The doctor, pharmacist or nurse will check that the solution is particle free before it is administered to you. OTHER MEDICINES AND ADDITRACE ® Talk to your doctor, pharmacist or nurse if you are taking, Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Additrace, concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Sterile, clear, almost colourless solution for addition to amino acid solutions • Osmolality: approx. 3100 mosm/kg water • pH: 2.3 – 2.8 Each ampoule contains 10ml of concentrate. Each 1 ml of concentrate contains: Ferric chloride, 6H2O Ph. Eur. 540 microgram Zinc chloride Ph. Eur 1.36 mg Manganese chloride 4H 2 O USP 99.0 microgram Copper chloride 2H 2 O USP 340 microgram Chromic chloride 6H 2 O USP 5.33 microgram Sodium selenite, 5H 2 O 10.5 microgram Sodium molybdate, 2H 2 O Ph. Eur. 4.85 microgram Sodium fluoride BP 210 microgram Potassium iodide Ph. Eur 16.6 microgram One 10ml ampoule of Additrace contains: Fe 3+ 20 micromol Zn 2+ 100 micromol Mn 2+ 5 micromol Cu 2+ 20 micromol Cr 3+ 0.2 micromol Se 4+ 0.4 micromol Mo 6+ 0.2 micromol F - 50 micromol I - 1 micromol Less than 1 mmol of both potassium and sodium. For a full list of excipients, see section 6.1. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _3_ _/_ _0_ _8_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _7_ _3_ _5_ _0_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A source of electrolytes and trace elements as an integral part of a complete intravenous nutritional regimen, for adults and children over 40 kg. 4.2 POSOLOGY AND MET Olvassa el a teljes dokumentumot