Vitalipid N® Infant and Adult Palmitate, , dl-alpha- and Phytomenadione

Consumer Medicine Information

What is in this leaflet Before you are given If you have not told your doctors about any of the above, tell them VITALIPID N before you are given VITALIPID N. This leaflet answers some You or your child should not be common questions about given VITALIPID N if: How to take VITALIPID VITALIPID N. It does not contain all the available information. It  You have an allergy to N does not take the place of talking soya oil, eggs, peanuts or to your doctor or pharmacist. any of the ingredients The dose of VITALIPID N will be listed at the end of this determined by the doctor or All medicines have risks and leaflet. pharmacist. The doctor will benefits. Your doctor has weighed  You have very high levels supervise your treatment or your the risks of you or your child given of in your system. child’s treatment with VITALIPID VITALIPID N against any benefits  You have a sudden, N. they expect it will have for you or dangerous drop in your your child. blood pressure. VITALIPID N is usually mixed in a

 You have an inability to bottle or a bag of amino acids, Please read this leaflet carefully break down fats. glucose and/or fats, fat-soluble before you are given VITALIPID vitamins and given as a continuous N. If you have any questions or If you are not sure whether any of infusion into a central vein. An are unsure about anything, these apply to you, check with your electronic pump may be used to please ask the doctor or doctor. control the speed of the infusion of pharmacist. drip.

You should tell your doctor Keep this leaflet with the BEFORE given VITALIPID N if the medicine. You may need to read Side Effects answer to any of the following it again. questions is YES. Since VITALIPID N has to be diluted with other nutrient What is VITALIPID N  Are you pregnant or trying solutions, it may cause unwanted used for to become pregnant? effects in some people. All the  Are you ? unwanted effects associated with  Are you allergic to soya-, VITALIPID N may not yet been VITALIPID N is a sterile emulsion egg- or peanut protein? which provides the body with fat- detected.  Do you have liver or soluble by the kidney disease? intravenous route. When the intake If you or your child have/has any  Are you taking of nutrients or food into the mouth unwanted effects during treatment, anticoagulants (medicines or directly into the gut is not tell your doctor or pharmacist. for preventing blood possible, or it is not enough to clotting)? supply the body’s needs, then If you are given too much  Are you taking any other intravenous nutrients or foods can (overdose) medicines including any be given. This is especially that you buy without a important for people whose bodies This rarely happens as VITALIPID prescription from your are under physical stress from N is administered under the care of pharmacy, supermarket or illness or recent surgery. During a trained professional in a hospital health food shop. These illness or after surgery the body or clinic setting. However if you or medicines may affect the requires nutrition or food. your child is given too much of action of VITALIPID N or VITALIPID N, you or your child may affect how well may experience a condition of high VITALIPID N works. levels of vitamins in your system.

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Your doctor has information on VITALIPID N INFANT how to recognise and treat an One mL contains the active overdose. Ask your doctor if you ingredients A (as retinol have any concerns. palmitate) 69 g, Ergocalciferol 1.0 g, dl-alpha-tocopherol 0.64 mg, Otherwise, immediately telephone Phytomenadione 20 g and your doctor or contact the Poisons excipients Soya oil 100 mg, Egg Information Centre in your country. lecithin 12 mg, Glycerol 22.0 mg, Australia: 13 11 26 Sodium hydroxide to pH 8 and New Zealand: 0800 764 766. Water for Injections to 1 mL.

Storage VITALIPID N does not contain gluten, lactose, sucrose, tartrazine

or any other azo dyes. Store below 25ºC. VITALIPID N does not contain any Protect from light and do not preservative. freeze.

Further Information Do not use this medicine after the expiry date which is stated on the More detailed information is carton label and embossed on the available from your doctor or ampoule. pharmacist. Therefore, if you have

any concerns about the The contents of each ampoule of information or about VITALIPID N VITALIPID N should be dissolved ask your doctor or pharmacist. first and then diluted for single infusion only. Sponsor Any unused VITALIPID N should be discarded. Australia: Fresenius Kabi Australia Pty Product Description Limited Level 2, 2 Woodland Way,

Mount Kuring-gai NSW 2080 What it looks like Australia

Telephone: (02) 9391 5555 VITALIPID N is a sterile, white emulsion in an ampoule. It comes New Zealand: in a carton pack of 10 ampoules. Fresenius Kabi New Zealand

Limited VITALIPID N can be identified by 60 Pavilion Drive the following: Airport Oaks, Auckland 2022

New Zealand Vitalipid N Adult – AUST R 40252 Freecall: 0800 144 892 Vitalipid N Infant – AUST R 40253

® = Registered Trademark Ingredients

Date of Information VITALIPID N ADULT This leaflet was prepared in One mL contains the active January 2017. ingredients (as retinol palmitate) 99 g, Ergocalciferol 0.5 g, dl-alpha-tocopherol 0.91 mg, Phytomenadione 15 g and excipients Soya oil 100 mg, Egg lecithin 12 mg, Glycerol 22.0 mg, Sodium hydroxide to pH 8 and Water for Injections to 1 mL.

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