国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
Soya Oil; Olive Oil
Baxter Healthcare Pty Ltd
Alanine,Arginine,calcium chloride dihydrate,glucose,Glycine,Histidine,Isoleucine,Leucine,Lysine,magnesium chloride hexahydrate,M
Injection, intravenous infusion
Excipient Ingredients: ascorbyl palmitate; glycerol; sodium oleate; water for injections; sodium hydroxide; egg lecithin
Intravenous Infusion
2000 mL
Not scheduled. Not considered by committee
Parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.
Visual Identification: smallest outside compartment containing a homogeneous liquid with a milky appearance.; Container Type: Bag; Container Material: Composite plastic laminate; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2007-09-04
OLICLINOMEL Consumer medicine Information WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OLICLINOMEL Intravenous (IV) Emulsion for Infusion and OLICLINOMEL IV Emulsion for Infusion with Electrolytes (called ‘OLICLINOMEL’ hereafter) . It does not contain all of 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 using OLICLINOMEL against the benefits he or she may expect it will have for you. If you have any concerns about being_ _administered this medicine, ask your doctor or pharmacist. Keep this leaflet. You may need to read it again. WHAT OLICLINOMEL IS USED FOR AND HOW IT WORKS OLICLINOMEL is a sterile emulsion containing fat (with soya_ _oil and olive oil as active components), amino acids and glucose. It is used as a source of energy, maintaining the nitrogen/energy balance and correcting essential fatty acids deficiency. OLICLINOMEL with Electrolytes also helps balance nutrient levels. OLICLINOMEL products are given as an infusion directly into your veins. They are intended to provide you with nourishment (essential fatty acids, proteins, glucose and other nutrients) whilst you are unable to consume food by mouth. BEFORE YOU ARE GIVEN OLICLINOMEL _ _ _OLICLINOMEL MUST _ _NOT BE GIVEN TO YOU/ _ _YOUR CHILD IF:_ • you/they have an allergy to components of the container or to any ingredient listed at the end of this leaflet; • you/they have had an allergic reaction to egg or soya protein containing foodstuffs or soybean products, amino acids, olive products components of the container or to any of the active or inactive ingredients. Some of the symptoms of an allergic reaction may include fever, shivering, skin rash, swelling of the face, lips or tongue, which may cause difficulty swallowing or shortness of breath; • you /they are suffering from one of the following conditions: • have an abnormal level of lipids in the blood; • sugar diabetes (requi 完全なドキュメントを読む
OLICLINOMEL Product Information NAME OF THE MEDICINE : OLICLINOMEL _Composition_: Lipid emulsion, amino acid solution and glucose solution presented in the form of a 3-compartment bag. There are eight different formulations of OLICLINOMEL, four with electrolytes and four without electrolytes. The general compositions of the formulations are summarised in the following table: WITHOUT ELECTROLYTES & CALCIUM WITH ELECTROLYTES NITROGEN 1 LIPID EMULSION 2 AMINO ACID SOLUTION 3 GLUCOSE SOLUTION 4 OLICLINOMEL N4- 550 OLICLINOMEL N4- 550E 3.6g/L 10% 5.5% 20% OLICLINOMEL N5- 800 OLICLINOMEL N5- 800E 4.6g/L 20% 7% 25% OLICLINOMEL N6- 900 OLICLINOMEL N6- 900E 5.6g/L 20% 8.5% 30% OLICLINOMEL N7- 1000 OLICLINOMEL N7- 1000E 6.6g/L 20% 10% 40% 1 Prefixes N4, N5, N6, N7 refer to rounded up content of nitrogen, expressed as g/L. 2 Contains refined olive oil (80%) and soya oils (20%) 3 Contains 15 L-series amino acids and electrolytes if present 4 Contains calcium, if present For the detailed formulations, refer to APPENDIX 1 . There are four presentations of each formulation, which have the following different volumes: COMPARTMENT 1000 ML 1500 ML 2000 ML 2500 ML Lipid emulsion 200 mL 300 mL 400 mL 500 mL Amino acid solution 400 mL 600 mL 800 mL 1000 mL Glucose solution 400 mL 600 mL 800 mL 1000 mL DESCRIPTION: _Appearance prior to reconstitution: _ OLICLINOMEL is presented in the form of a 3-compartment bag, each containing liquids: • The lipid emulsion is a homogeneous liquid with a milky appearance • The amino acid and glucose solutions are clear and colourless or slightly yellow liquids. After reconstitution, OLICLINOMEL is a milk-like homogeneous liquid (see PRESENTATIONS AND STORAGE CONDITIONS for further information). OLICLINOMEL is a hypertonic emulsion. The osmolality and energy contents of the formulations are as follows: OLICLINOMEL PI ( ccds40520140925) Page 1 of 23 Baxter Healthcare OLICLINOMEL Product Information FORMULATION OSMOLALITY MOSMOL/KG ENERGY CONTENT KJ/L (KCAL/L) FORMULATION OSMOLALITY MOSMOL/KG ENERGY 完全なドキュメントを読む