Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Soya bean oil, refined; Calcium chloride dihydrate; Methionine; Potassium chloride; Tryptophan; Olive oil, refined; Zinc sulphate heptahydrate; Phenylalanine; Triglycerides medium-chain; Proline; Isoleucine; Magnesium sulfate heptahydrate; Alanine; Tyrosine; Sodium acetate trihydrate; Serine; Sodium glycerophophate hydrate; Arginine; GLUCOSE MONOHYDRATE; Taurine; GLYCINE; Valine; Lysine acetate; Fish oil, rich in omega-3 acids; Leucine; Histidine
Fresenius Kabi Limited
B05BA; B05BA10
Soya bean oil, refined; Calcium chloride dihydrate; Methionine; Potassium chloride; Tryptophan; Olive oil, refined; Zinc sulphate heptahydrate; Phenylalanine; Triglycerides medium-chain; Proline; Isoleucine; Magnesium sulfate heptahydrate; Alanine; Tyrosin
Unknown
Emulsion for infusion
Product subject to prescription which may not be renewed (A)
Solutions for parenteral nutrition; combinations
Authorised
2017-08-25
337 103 _SMOFKABIVEN EXTRA NITROGEN _ emulsion for infusion - if you have serious liver disorder - if you have blood clotting problems (coagulation disorder) - if your body has problems using amino acids - if you have serious kidney disease without access to dialysis - if you are in acute shock - if you have too much sugar in your blood (hyperglycaemia) which is uncontrolled - if you have high blood (serum) levels of the salts (electrolytes) included in SmofKabiven extra Nitrogen - if you have fluid in the lungs (acute pulmonary oedema) - if you have too much body fluid (hyperhydrated) - if you have heart failure that is not treated - if you have a defect in your blood clotting system (hemo- phagocytotic syndrome) - if you are in an unstable condition, such as after serious trauma, uncontrolled diabetes, acute heart attack, stroke, blood clot, metabolic acidosis (a disturbance resulting in too much acid in the blood), serious infection (severe sepsis), coma and if you don’t have enough body fluid (hypotonic dehydration) - in newborn babies or children under 2 years of age Warnings and precautions Talk to your doctor before using SmofKabiven extra Nitrogen if you have: - kidney problems - diabetes mellitus - pancreatitis (inflammation of the pancreas) - liver problems - hypothyrodism (thyroid problems) - sepsis (serious infection) If you during the infusion get fever, rash, swelling, difficulty in breathing, chills, sweating, nausea or vomiting, tell the healthcare professional immediately because these symp- toms might be caused by an allergic reaction or that you have been given too much of the medicine. Your doctor may regularly need to check your blood for liver function tests and other values. Children and adolescents SmofKabiven extra Nitrogen is not meant for newborn ba- bies or children younger than 2 years of age. SmofKabiven extra Nitrogen can be given to children and adolescents from 2 to 16/18 years old. Other medicines and SmofKabiven extra Nitrogen Tell your doctor if you are taking, have recently Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SmofKabiven extra Nitrogen, emulsion for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SmofKabiven extra Nitrogen consists of a three chamber bag system. Each bag contains the following partial volumes depending on the five pack sizes. This corresponds to the following total compositions: 506 ML 1012 ML 1518 ML 2025 ML 2531 ML PER 1000 ML Amino acid solution 10% with electrolytes 331 ml 662 ml 993 ml 1325 ml 1656 ml 654 ml Glucose 42% 102 ml 204 ml 306 ml 408 ml 510 ml 202 ml Lipid emulsion 20% 73 ml 146 ml 219 ml 292 ml 365 ml 144 ml ACTIVE INGREDIENTS 506 ML 1012 ML 1518ML 2025 ML 2531 ML PER 1000 ML Alanine 4.6 g 9.3 g 14 g 19 g 23 g 9.2 g Arginine 4.0 g 7.9 g 12 g 16 g 20 g 7.9 g Glycine 3.6 g 7.3 g 11 g 15 g 18 g 7.2 g Histidine 1.0 g 2.0 g 3.0 g 4.0 g 5.0 g 2.0 g Isoleucine 1.7 g 3.3 g 5.0 g 6.6 g 8.3 g 3.3 g Leucine 2.4 g 4.9 g 7.3 g 9.8 g 12 g 4.8 g Lysine (as acetate) 2.2 g 4.4 g 6.6 g 8.7 g 11 g 4.3 g Methionine 1.4 g 2.8 g 4.3 g 5.7 g 7.1 g 2.8 g Phenylalanine 1.7 g 3.4 g 5.1 g 6.8 g 8.4 g 3.3 g Proline 3.7 g 7.4 g 11 g 15 g 19 g 7.3 g Serine 2.2 g 4.3 g 6.5 g 8.6 g 11 g 4.3 g Taurine 0.33 g 0.66 g 1.0 g 1.3 g 1.7 g 0.65 g Threonine 1.5 g 2.9 g 4.4 g 5.8 g 7.3 g 2.9 g Tryptophan 0.66 g 1.3 g 2.0 g 2.7 g 3.3 g 1.3 g Tyrosine 0.13 g 0.26 g 0.40 g 0.53 g 0.66 g 0.26 g Valine 2.1 g 4.1 g 6.2 g 8.2 g 10 g 4.1 g Calcium chloride dihydrate _corresponding to_ Calcium chloride 0.14 g 0.29 g 0.43 g 0.58 g 0.72 g 0.28 g Sodium glycerophosphate (hydrate)_ corresponding to_ Sodium glycerophosphate 1.2 g 2.3 g 3.5 g 4.6 g 5.8 g 2.3 g Magnesium sulphate heptahydrate_ corresponding_ _to_ Magnesium sulphate 0.31 g 0.62 g 0.92 g 1.2 g 1.5 g 0.61 g Potassium chloride 1.2 g 2.3 g 3.5 g 4.6 g 5.8 g 2.3 g Sodium acetate trihydrate _corresponding to_ Sodium acetate 0.82 g 1.6 g 2.5 g 3.3 g 4.1 g 1.6 g Zinc sulphate heptahydrate 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Прочитайте повний документ