Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
chromic chloride hexahydrate, Quantity: 5.33 microgram/mL; ferric chloride hexahydrate, Quantity: 540 microgram/mL; sodium selenite, Quantity: 17.29 microgram/mL; sodium fluoride, Quantity: 210 microgram/mL; cupric chloride dihydrate, Quantity: 102.3 microgram/mL; potassium iodide, Quantity: 16.6 microgram/mL; sodium molybdate dihydrate, Quantity: 4.85 microgram/mL; manganese chloride tetrahydrate, Quantity: 19.79 microgram/mL; zinc chloride, Quantity: 1.05 mg/mL
Fresenius Kabi Australia Pty Ltd
chromic chloride hexahydrate,cupric chloride dihydrate,Ferric chloride hexahydrate,manganese chloride tetrahydrate,Potassium iod
Injection, concentrated
Excipient Ingredients: water for injections; hydrochloric acid; xylitol
Intravenous Infusion
20
Not scheduled. Not considered by committee
To meet basal to moderately increased requirements of trace elements in parenteral nutrition in adults, when either oral or enteral nutrition is inappropriate
Visual Identification: Clear and colourless to slightly yellow solution.; Container Type: Ampoule; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-07-29
ADDAVEN ® Concentrated solution for injection CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Addaven. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Addaven against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT ADDAVEN IS USED FOR Addaven is a medicine that contains trace elements. Trace elements are tiny amounts of chemicals that your body needs to function normally. Addaven is given intravenously (as a drip into a vein) when you cannot eat normally. This medicine is usually used as part of a balanced intravenous diet, together with proteins, fat, carbohydrates, salts and vitamins. BEFORE YOU ARE GIVEN ADDAVEN _WHEN YOU MUST NOT TAKE IT _ if you are allergic to any of the ingredients of this medicine. 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 under 12 years of age. _BEFORE YOU START TO TAKE IT _ 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 parallel with the infusion your doctor will check that iron is not accumulating in your body. Iron and iodine may cause allergic reactions on rare occasions when given as a drip. Tell your doctor or nurse if you get any allergic reaction when receiving Addaven. _PREGNANCY AND BREAST-FEEDING _ If you are pregnant or breast- feeding, think you may be pregnant or Přečtěte si celý dokument
AUSTRALIAN PRODUCT INFORMATION - ADDAVEN ® (CHROMIUM, COPPER, IRON, MANGANESE, IODINE, FLUORIDE, MOLYBDENUM, SELENIUM, ZINC) Page 1 of 7 1 NAME OF MEDICINE Chromic chloride hexahydrate Cupric chloride dihydrate Ferric chloride hexahydrate Manganese chloride tetrahydrate Potassium iodide Sodium fluoride Sodium molybdate dihydrate Sodium selenite Zinc chloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mL ampoule of Addaven contains: Chromic chloride hexahydrate 53.33 µg Cupric chloride dihydrate 1.02 mg Ferric chloride hexahydrate 5.40 mg Manganese chloride tetrahydrate 198 µg Potassium iodide 166 µg Sodium fluoride 2.10 mg Sodium molybdate dihydrate 48.5 µg Sodium selenite 173 µg Zinc chloride 10.5 mg The active ingredients per 10 mL of Addaven correspond to the following electrolyte profile: Chromium (Cr 3+ ) 0.20 µmol (10 µg) Copper (Cu 2+ ) 6.0 µmol (380 µg) Iron (Fe 3+ ) 20 µmol (1.10 mg) Manganese (Mn 2+ ) 1.0 µmol (55 µg) Iodine (I - ) 1.0 µmol (130 µg) Fluoride (F - ) 50 µmol (950 µg) Molybdenum (Mo 6+ ) 0.20 µmol (19 µg) Selenium (Se 4+ ) 1.0 µmol (79 µg) Zinc (Zn 2+ ) 77 µmol (5.0 mg) The content of sodium and potassium correspond to: Sodium content: 52 µmol (1.20 mg) Potassium content: 1 µmol (39 µg) Excipients with known effect: Xylitol For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Addaven is a concentrated trace element solution for intravenous infusion which is clear and colourless to slightly yellow. Osmolality: 3100 mOsm/kg water pH: 2.5 Page 2 of 7 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To meet basal to moderately increased requirements of trace elements in parenteral nutrition in adults, when either oral or enteral nutrition is inappropriate. 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage The recommended daily dosage of Addaven in patients over 12 years of age with basal to moderately increased requirements is 10 mL (one ampoule). In patients with renal or hepatic impairments, or mild cholestasis the dose shou Přečtěte si celý dokument