Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
CHROMIC CHLORIDE, POTASSIUM IODIDE, COPPER CHLORIDE, FERRIC CHLORIDE, ZINC CHLORIDE, MANGANESE CHLORIDE, SODIUM FLUORIDE, SODIUM MOLYBDATE, SODIUM SELENITE
Fresenius Kabi Limited Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire WA7 1NT, United Kingdom
B05XA
CHROMIC CHLORIDE 5.33 µg POTASSIUM IODIDE 16.6 µg COPPER CHLORIDE 340 µg FERRIC CHLORIDE 544 µg ZINC CHLORIDE 1.36 mg MANGANESE CHLORIDE 99 µg SODIUM FLUORIDE 210 µg SODIUM MOLYBDATE 4.85 µg SODIUM SELENITE 10.5 µg
CONCENTRATE FOR SOLUTION FOR INFUSION
CHROMIC CHLORIDE 5.33 µg POTASSIUM IODIDE 16.6 µg COPPER CHLORIDE 340 µg FERRIC CHLORIDE 544 µg ZINC CHLORIDE 1.36 mg MANGANESE CHLORIDE 99 µg SODIUM FLUORIDE 210 µg SODIUM MOLYBDATE 4.85 µg SODIUM SELENITE 10.5 µg
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Withdrawn
2006-11-01
32 32 15801016D.indd 1 2012-03-14 10:13:02 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Additrace ® infusions contain Each vial contains 10ml of concentrate. ACTIVE INGREDIENTS: 1 MILLILITRE OF ADDITRACE ® CONTAINS: EACH VIAL CONTAINS 10ML OF CONCENTRATE. Ferric chloride, 6H 2 O 540 microgram 20 micromol Zinc chloride 1.36 mg 100 micromol Manganese chloride 99.0 microgram 5 micromol Copper chloride 340 microgram 20 micromol Chromic chloride 5.33 microgram 0.2 micromol Sodium selenite anhydrous 6.9 microgram 0.4 micromol Sodium molybdate, 2H 2 O 4.85 microgram 0.2 micromol Sodium fluoride 210 microgram 50 micromol Potassium iodide 16.6 microgram 1 micromol Note: Less than 1 mmol for potassium and sodium Additrace ® also contains xylitol, hydrochloric acid, water for injections. What Additrace® looks like and contents of the pack Additrace ® is a clear, almost colourless solution of trace elements. Additrace is available in a clear glass ampoule or polypropylene ampoule containing 10 ml of concentrate, in the following pack sizes: • glass ampoule, 10 x 10ml • polypropylene ampoule, 20 x 10 ml Not all pack sizes may be marketed. 15801016D.indd 2 2012-03-14 10:13:02 Baca dokumen lengkapnya
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Additrace® Concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 10ml of concentrate. Each 1 ml of concentrate contains: Ferric chloride, 6H2O 540 microgram Zinc chloride 1.36 mg Manganese chloride 99.0 microgram Copper chloride 340 microgram Chromic chloride 5.33 microgram Sodium selenite, 5H2O 10.5 microgram Sodium molybdate, 2H2O 4.85 microgram Sodium fluoride 210 microgram Potassium iodide 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 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 Page 2 of 5 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A source of electrolytes and trace elements as an integral part of complete intravenous regimen, for adults and children over 40kg. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Route of administration:_ Intravenous infusion after dilution Additrace must not be given undiluted. For instructions on dilution of the medicinal product before administration, see section 6.6. Baca dokumen lengkapnya