Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
dl-alpha-tocopherol, Quantity: 0.64 mg/mL; retinol palmitate, Quantity: 135.3 microgram/mL; phytomenadione, Quantity: 20 microgram/mL; ergocalciferol, Quantity: 1 microgram/mL
Fresenius Kabi Australia Pty Ltd
dl-alpha-Tocopherol,Ergocalciferol,Phytomenadione,retinol palmitate
Injection, concentrated
Excipient Ingredients: sodium hydroxide; water for injections; glycerol; egg lecithin; Soya Oil
Intravenous
10 x 10mL ampoules
Not scheduled. Not considered by committee
Vitalipid N Infant is indicated as a supplement in complete intravenous nutrition to meet the daily requirements of the fat- soluble Vitamins A, D2, E and K1 in paediatric patients up to 11 years of age.
Visual Identification: A milky white emulsion.; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1992-08-21
Page 1 of 2 VITALIPID N ® INFANT AND ADULT Retinol Palmitate, Ergocalciferol, dl-alpha-tocopherol and Phytomenadione CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VITALIPID N. 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 or your child given VITALIPID N against any benefits they expect it will have for you or your child. PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN VITALIPID N. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT ANYTHING, PLEASE ASK THE DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT IS VITALIPID N USED FOR VITALIPID N is a sterile emulsion which provides the body with fat- soluble multivitamins by the intravenous route. When the intake of nutrients or food into the mouth or directly into the gut is not possible, or it is not enough to supply the body’s needs, then intravenous nutrients or foods can be given. This is especially important for people whose bodies are under physical stress from illness or recent surgery. During illness or after surgery the body requires nutrition or food. BEFORE YOU ARE GIVEN VITALIPID N You or your child should not be given VITALIPID N if: You have an allergy to soya oil, eggs, peanuts or any of the ingredients listed at the end of this leaflet. You have very high levels of vitamins in your system. You have a sudden, dangerous drop in your blood pressure. You have an inability to break down fats. If you are not sure whether any of these apply to you, check with your doctor. You should tell your doctor BEFORE given VITALIPID N if the answer to any of the following questions is YES. Are you pregnant or trying to become pregnant? Are you breastfeeding? Are you allergic to soya-, egg- or peanut protein? Do you have liver or kidney disease? Are you taking anticoagulants (med Lire le document complet
AUSTRALIAN PRODUCT INFORMATION - VITALIPID ® N ADULT AND VITALIPID ® N INFANT (RETINOL PALMITATE, ERGOCALCIFEROL, DL-ALPHA-TOCOPHEROL, PHYTOMENADIONE) Page 1 of 6 1 NAME OF MEDICINE Retinol palmitate (Vitamin A palmitate) Ergocalciferol (Vitamin D 2 ) dl-alpha-tocopherol (Vitamin E) Phytomenadione (Vitamin K 1 ) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 10 mL ampoule contains: Adult Infant Retinol palmitate 1.941 mg 1.353 mg _corresponding to retinol (Vitamin A) _ _ 990 _ _g (3300 IU) _ _ 690 _ _g (2300 IU)_ Ergocalciferol (Vitamin D 2 ) 5 g (200 IU) 10 g (400 IU) dl-alpha-tocopherol (Vitamin E) 9.1 mg 10 IU) 6.4 mg (7.0 IU) Phytomenadione (Vitamin K 1 ) 150 g 200 g Excipients with known effect: Soya oil, Egg lecithin For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Concentrated Emulsion for Injection. A milky white emulsion. Sterile oil/water emulsion with pH: approx..8 and osmolality: approx. 300 mOsm/kg water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vitalipid N Adult is indicated as a supplement in complete intravenous nutrition to meet the daily requirements of the fat-soluble vitamins A, D 2 , E and K 1 . Vitalipid N Infant is indicated as a supplement in complete intravenous nutrition to meet the daily requirements of the fat-soluble vitamins A, D 2 , E and K 1 in paediatric patients up to 11 years of age. 4.2 DOSE AND METHOD OF ADMINISTRATION Must be diluted before use: Adults and children aged 11 years and above. Vitalipid N Adult should be added aseptically within one hour of the commencement of the infusion and should be used within 24 hours. Must be diluted before use: Infants and children under 11 years. Vitalipid N Infant in a dosage of 1 mL per kg bodyweight per day is added to Intralipid 10% or 20%. The daily dose must not exceed 10 mL. After mixing by gentle agitation the emulsion is infused as described for Intralipid. Page 2 of 6 Vitalipid N Infant should be added aseptically within one hour of the commencement of th Lire le document complet