국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
Olive Oil, Quantity: 0 QS; Soya Oil, Quantity: 0 QS
Baxter Healthcare Pty Ltd
Injection, emulsion
Excipient Ingredients: sodium oleate; egg lecithin; sodium hydroxide; glycerol; ascorbyl palmitate; water for injections
Intravenous
250mL, 350mL, 500mL, 100mL, 1000mL
Not scheduled. Not considered by committee
Parenteral nutrition when oral or enteral nutrition is impossible, insufficient or contraindicated.
Visual Identification: Milky white emulsion.; Container Type: Bag; Container Material: Plastic; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2004-02-19
CLINOLEIC CMI Page 1 of 2 Baxter CLINOLEIC _soya oil and olive oil emulsion _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET _ _ This leaflet answers some common questions about CLINOLEIC 20%. It does not contain all of the available information. All medicines have risks and benefits. Your doctor has weighed the risks of you using ClinOleic against the benefit they expect it will have for you. It does not take the place of talking to your doctor or pharmacist. If you have any concerns about being_ _administered this medicine, ask your doctor or pharmacist. WHAT CLINOLEIC IS USED FOR ClinOleic is a sterile fat emulsion containing soya_ _ oil and olive oil as active components. It is used as a source of energy and for correction of essential fatty acids deficiency, and is given as an infusion directly into your veins. ClinOleic is intended to provide you with nourishment (essential fatty acids) whilst you are unable to consume food by mouth. BEFORE YOU ARE GIVEN CLINOLEIC _CLINOLEIC SHOULD NOT BE _ _GIVEN TO YOU IF: _ you have an allergy to any ingredient listed at the end of this leaflet; you have had an allergic reaction to egg-yolk containing foodstuffs or soybean products. Some of the symptoms of an allergic reaction may include skin rash, peeling of the skin and swelling of the face, lips or tongue causing difficulty swallowing or shortness of breath; you have one of the following conditions: - an abnormal level of lipids in the blood - uncontrolled diabetes, lactic acidosis - a blood or other infection - severe liver disease - blood clotting problems - kidney disease - heart attack The expiry date printed on the pack has passed. _ _ _YOU MUST TELL YOUR DOCTOR IF _ _YOU: _ are fluid overloaded or overhydrated; have diabetes; have liver disease are taking any prescription medicine are taking any other medicines including nutritional supplements, purchased from your pharmacy, supermarket or health food stores, , in particular warfarin; are pregnant;_ _ are breas 전체 문서 읽기
ClinOleic 20% Version 2.0 Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION – CLINOLEIC 20% (SOYA OIL AND OLIVE OIL) EMULSION FOR INJECTION 1 NAME OF THE MEDICINE Olive oil and Soya oil. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ClinOleic is a sterile fat emulsion [containing a mixture of refined Olive oil (approximately 80%) and refined Soya oil (approximately 20%)] 200 g, Egg lecithin (purified egg phospholipids) 12 g, Glycerol 22.5 g, Sodium oleate 0.3 g and Water for Injections to 1,000 mL (final pH between 6.0- 8.0). One of the active ingredients, Soya oil, contains ascorbyl palmitate as an antioxidant (free radical scavenger), in the concentration of 0.15 mg/g of oil. 3 PHARMACEUTICAL FORM ClinOleic is an emulsion for intravenous injection. ClinOleic 20% is a milk-like homogeneous liquid. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Parenteral nutrition when oral or enteral nutrition is impossible, insufficient or contraindicated. 4.2 D OSE AND METHOD OF ADMINISTRATION The dosage depends on energy expenditure, the patient’s clinical status, body weight, and ability to metabolise ClinOleic 20%, as well as additional energy given orally/enterally. Therefore, the dosage should be individualised and the bag size chosen accordingly. The maximum daily dose of ClinOleic 20% should be based on individual total nutritional requirements and patient tolerance. _DOSAGE _ _Note_: the percentage (%) of lipid in the ClinOleic 20% formulation is expressed in weight by volume (w/v). That is, 5 mL of ClinOleic 20% contains 1 g of lipid. • _Adult_: The dosage is 1 to a maximum of 2 g lipids/kg/day. Never exceed 0.15 g lipids/kg/hour (0.75 mL/kg/hour). ClinOleic 20% Version 2.0 Page 2 of 16 TABLE 1: CLINOLEIC DOSAGE OF ADULTS ADULTS PER KG OF BODY WEIGHT 70 KG ADULT Usual lipid dosage 1 to 2 g/kg/day 70 to 140 g/day Infused volume of ClinOleic 20% 5 to 10 mL/kg/day 350 to 700 mL/day • _Children_: It is recommended not to exceed a daily dose of 3g lipids/kg of body weight and an infusion rate of 0.15 g lipids/kg of bo 전체 문서 읽기