Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
SOYBEAN OIL ; TRIGLYCERIDES, MEDIUM CHAIN; REFINED OLIVE OIL; PURIFIED FISH OIL
Fresenius Kabi Limited
B05BA02
SOYBEAN OIL ; TRIGLYCERIDES, MEDIUM CHAIN; REFINED OLIVE OIL; PURIFIED FISH OIL
20% Per Cent
Emulsion for Infusion
Product subject to prescription which may not be renewed (A)
fat emulsions
Marketed
2004-10-27
SMOFLIPID PIL - UK (ersätter) Tryckspecifikation Format: 630 x 210 mm Färger: PMS svart Utskrift: anpassat till A3 Fontsize: 8 pt 6:e korr 2016-11-01 Johanna Eriksson v002/UP/BIO xxx xxx _SMOFLIPID 200 MG/ML,_ _EMULSION FOR INFUSION_ SOYA-BEAN OIL, MEDIUM CHAIN TRIGLYCERIDES, OLIVE OIL, FISH OIL - if you are in an unstable condition, for example shortly after serious injury, heart attack, stroke, blood clot (thrombosis), metabolic acidosis (metabolic disturbance which results in high acid levels in the blood), or untreated diabetes, blood poisoning and dehydration. Warnings and precautions Talk to your doctor or nurse before having this medicine if you have a problem with high levels of lipids in the blood due to that your body cannot use fat properly (called ‘impaired lipid metabolism’). Allergic reactions If you have an allergic reaction while having SMOFlipid, it needs to be stopped straight away. Tell the doctor or nurse straight away if you get any of the following while you are having the infusion: - fever (high temperature) - shivering - rash - difficulty breathing Children Talk to your doctor or nurse if this medicine is being given to your newborn child and they have: - too much of a substance called “bilirubin” in their blood (hyperbiliribinemia) - a high pressure in their lungs (pulmonary hypertension) If your newborn child has SMOFlipid for a long time the doctor will take blood tests to see how it is working. Other medicines and SMOFlipid Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking or have recently taken drugs used to stop blood clotting, such as warfarin and heparin. - SMOFlipid naturally contains vitamin K1, which can affect warfarin. However, the vitamin K1 content in SMOFlipid is so low that such problems are unlikely. - Heparin given in clinical doses may at first cause higher levels of fatty acids in the blood due to liberation of fatty acids from the tissues into the bloodstream and then Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SMOFlipid 200 mg/ml emulsion for infusion, glass bottle. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients with known effect: 1000 ml emulsion contains up to 5 mmol sodium (as sodium hydroxide and sodium oleate). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Emulsion for infusion White homogenous emulsion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Supply of energy and essential fatty acids and omega-3 fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The patient’s ability to eliminate the fat infused, should govern the dosage and infusion rate, see section 4.4. _ADULTS_ The standard dose is 1.0 – 2.0 g fat/kg body weight (b.w.)/day, corresponding to 5 – 10 ml/kg b.w./day. The recommended infusion rate is 0.125 g fat/kg b.w./hour, corresponding to 0.63 ml Smoflipid/kg b.w./hour, and should not exceed 0.15 g fat/kg b.w./hour, corresponding to 0.75 ml Smoflipid/kg b.w./hour. _PAEDIATRIC POPULATION_ Neonates and infants The initial dose should be 0.5 – 1.0 g fat/kg b.w./day followed by a successive increase by 0.5 – 1.0 g fat/kg b.w./day up to 3.0 g fat/kg b.w./day. It is recommended not to exceed a daily dose of 3 g fat/kg b.w./d, corresponding to 15 ml Smoflipid/kg b.w./day. 1000 ml of emulsion for infusion contain: Soya-bean oil, refined 60.0 g Triglycerides, medium-chain 60.0 g Olive oil, refined 50.0 g Fish oil, rich in omega-3-acids 30.0 g Total energy: 8.4 MJ/l (= 2000kcal/l) pH-value: approx. 8 Osmolality approx. 380 mosm/kg H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Lees het volledige document