Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Chromium trichloride hexahydrate 5.33 µg/mL; ; Copper chloride dihydrate 0.34 mg/mL; ; Ferric chloride hexahydrate 0.54 mg/mL; ; Manganese chloride tetrahydrate 99 µg/mL; ; Potassium iodide 16.6 µg/mL; Sodium fluoride 0.21 mg/mL; Sodium molybdate dihydrate 4.85 µg/mL; ; Sodium selenite 10.5 µg/mL; ; ; Zinc chloride 1.36 mg/mL; ; ; Chromium trichloride hexahydrate 5.33 µg/mL; Copper chloride dihydrate 102.3 µg/mL; Ferric chloride hexahydrate 540 µg/mL; Manganese chloride tetrahydrate 19.79 µg/mL; Potassium iodide 16.6 µg/mL; Sodium fluoride 210 µg/mL; Sodium molybdate dihydrate 4.85 µg/mL; Sodium selenite 17.29 µg/mL; Zinc chloride 1050 µg/mL
Fresenius Kabi New Zealand Limited
Chromium trichloride hexahydrate 5.33 µg/mL
Solution for infusion
Active: Chromium trichloride hexahydrate 5.33 µg/mL Copper chloride dihydrate 0.34 mg/mL Ferric chloride hexahydrate 0.54 mg/mL Manganese chloride tetrahydrate 99 µg/mL Potassium iodide 16.6 µg/mL Sodium fluoride 0.21 mg/mL Sodium molybdate dihydrate 4.85 µg/mL Sodium selenite 10.5 µg/mL Zinc chloride 1.36 mg/mL Excipient: Hydrochloric acid Water for injection Xylitol Active: Chromium trichloride hexahydrate 5.33 µg/mL Copper chloride dihydrate 102.3 µg/mL Ferric chloride hexahydrate 540 µg/mL Manganese chloride tetrahydrate 19.79 µg/mL Potassium iodide 16.6 µg/mL Sodium fluoride 210 µg/mL Sodium molybdate dihydrate 4.85 µg/mL Sodium selenite 17.29 µg/mL Zinc chloride 1050 µg/mL Excipient: Hydrochloric acid Water for injection Xylitol
Ampoule, plastic, 10ml polypropylene single dose amp, 20 dose units
General sale
General sale
Merck KGaA
To meet basal to moderately increased requirements of trace elements in parenteral nutrition in adults and children weighing 15 kg and over, when either oral or enteral nutrition is inappropriate
Package - Contents - Shelf Life: Ampoule, plastic, 10ml polypropylene single dose amp - 20 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C
1990-08-27
Addaven CMI – NEW ZEALAND ADDAVEN ® Infusion, solution concentrate 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 less than 15 kg body weight. _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, Read the complete document
Page 1 of 6 NEW ZEALAND DATA SHEET 1. PRODUCT NAME ADDAVEN ® (infusion, solution concentrate) 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) For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Addaven is a concentrated trace element solution for infusion which is clear and colourless to slightly yellow. Osmolality: 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 parenteral nutrition in adults and children weighing 15 kg and over, when either oral or enteral nutrition is inappropriate 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage _Adults:_ The recommended daily dosage of Addaven in adult patients with basal to moderately increased requirements is 10 mL (one ampoule). In patients with renal or hepatic impairments, or mild cholestasis the dose should be adapted. Page 2 of 6 _Children ≥ 15kg:_ 0.1 mL Addaven is given per kg body weight and day. Method of administration Addaven must not be given undiluted. Addaven shall be diluted in a parenteral nutrition solution/emulsion before being given as an intravenous infusion. Information on admixtures is availabl Read the complete document