MAXIVALEN

Posology The patient’s ability to eliminate the fat infused, should govern the dose and infusion rate, see section

8. This medicinal product contains soya-bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut. Lipid emulsions should be given with caution in conditions of impaired lipid metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism, and sepsis.

Clinical data in patients with diabetes mellitus or renal failure are limited. Administration of medium-chain fatty acids alone can result in metabolic acidosis. This risk is to a great extent eliminated by the simultaneous infusion of the long chain fatty acids included in Maxivalen.

Concomitant administration of carbohydrates will further eliminate this risk. Hence, simultaneous infusion of carbohydrate or a carbohydrate-containing amino acid solution is recommended. Laboratory test generally associated with monitoring of intravenous nutrition should be checked regularly.

These include blood glucose levels, liver functions tests, acid base metabolism, fluid balance, full blood count and electrolytes. Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.

Lipid emulsions should be given with caution to neonates and premature neonates with hyperbilirubinemia and cases with pulmonary hypertension. In neonates, particularly premature neonates on long term parenteral nutrition, blood platelet counts, liver function tests and serum triglycerides should be monitored.

Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products. 6).

g. haemoglobin. 100 ml, 250 ml bags: This medicinal product contains less than 1 mmol sodium (23 mg) per bag, that is to say essentially ‘sodium free’. 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 6). 5 Interaction with other medicinal products and other forms of interaction Heparin given in clinical doses causes a transient increase in lipoprotein lipase release into the circulation.

This may initially result in increased plasma lipolysis, followed by a transient decrease in triglyceride clearance. Soya-bean oil has a natural content of vitamin K1. The content is however so low in Maxivalen that it is not expected to significantly influence the coagulation process in patients treated with coumarin derivatives.

6 Fertility, pregnancy and lactation There are no data available on exposure of lipid emulsions in pregnant or breast- feeding women. There are no studies available on reproductive toxicity in animals. Parenteral nutrition may become necessary during pregnancy and lactation.

Lipid emulsions should only be given to pregnant and breast-feeding women after careful consideration. 7 Effects on ability to drive and use machines Not relevant. g. site conditions anaphylactic or anaphylactoid reactions, skin rash, urticaria, flush, headache), heat or cold sensation, paleness, cyanosis, pain in the neck, back, bones, chest and loins Should these side-effects occur or should the triglyceride level during infusion rise above 3 mmol/l, the infusion of Maxivalen should be stopped or, if necessary, continued at a reduced dose.

Maxivalen should always be a part of a complete parenteral nutritional treatment including amino acids and glucose. Nausea, vomiting and hyperglycemia are symptoms related to conditions indicating parenteral nutrition and may sometimes be associated with parenteral nutrition.

Monitoring of triglycerides and blood glucose levels are recommended to avoid elevated levels, which may be harmful. Fat overload syndrome Impaired capacity to eliminate triglycerides can lead to “Fat overload syndrome” which may be caused by overdose.

Possible signs of metabolic overload must be observed. The cause may be genetic (individually different metabolism) or the fat metabolism may be affected by ongoing or previous illnesses. This syndrome may also appear during severe hypertriglyceridemia, even at the recommended infusion rate, and in association with a sudden change in the patient’s clinical condition, such as renal function impairment or infection.

The fat overload syndrome is characterised by hyperlipemia, fever, fat infiltration, hepatomegaly with or without icterus, splenomegaly, anaemia, leukopenia, thrombocytopenia, coagulation disorder, hemolysis and reticulocytosis, abnormal liver function tests and coma.

The symptoms are usually reversible if the infusion of the fat emulsion is discontinued. Should signs of a fat overload syndrome occur, the infusion of Maxivalen should be discontinued. Reporting of suspected adverse reactions Reporting suspected adverse reactions […]

4. /day. /hour. /day. /day. /hour. In premature and low birthweight neonates, Maxivalen should be infused continuously over about 24 hours. /day. The daily dose should be increased gradually during the first week of administration. /hour. Method of administration Intravenous infusion into a peripheral or central vein.

6). 1. - Severe hyperlipidemia. - Severe liver insufficiency. - Severe blood coagulation disorders. - Severe renal insufficiency without access to hemofiltration or dialysis. - Acute shock. - General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency.

g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration). 4 Special warnings and precautions for use The capacity to eliminate fat is individual and should therefore be monitored according to the routines of the clinician.

This is in general done by checking the triglyceride levels. g. patients with high lipid dose, severe sepsis and extremely low birth weight infants). The concentration of triglycerides in serum should in general not exceed 3 mmol/l during infusion.

Reduction of the dose or cessation of the lipid emulsion should be considered if serum or plasma triglyceride concentrations during or after infusion exceed 3 mmol/l. 8. This medicinal product contains soya-bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions.

Cross allergic reaction has been observed between soya-bean and peanut. Lipid emulsions should be given with caution in conditions of impaired lipid metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism, and sepsis.

Clinical data in patients with diabetes mellitus or renal failure are limited. Administration of medium-chain fatty acids alone can result in metabolic acidosis. This risk is to a great extent eliminated by the simultaneous infusion of the long chain fatty acids included in Maxivalen.

Concomitant administration of carbohydrates will further eliminate this risk. Hence, simultaneous infusion of carbohydrate or a carbohydrate-containing amino acid solution is recommended. Laboratory test generally associated with monitoring of intravenous nutrition should be checked regularly.

These include blood glucose levels, liver functions tests, acid base metabolism, fluid balance, full blood count and electrolytes. Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.

Lipid emulsions should be given with caution to neonates and premature neonates with hyperbilirubinemia and cases with pulmonary hypertension. In neonates, particularly premature neonates on long term parenteral nutrition, blood platelet counts, liver function tests and serum triglycerides should be monitored.

Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products. 6).

g. haemoglobin. 100 ml, 250 ml bags: This medicinal product contains less than 1 mmol sodium (23 mg) per bag, that is to say essentially ‘sodium free’. 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 6).

1. - Severe hyperlipidemia. - Severe liver insufficiency. - Severe blood coagulation disorders. - Severe renal insufficiency without access to hemofiltration or dialysis. - Acute shock. - General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency.

g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration).