Omegaven

/ Cure Medical & Technical Supply

Daily dose: 1 ml up to max. 2 ml Omegaven/kg body weight = 0.1 g up to max. 0.2 g fish oil/kg body weight = 70 ml up to max. 140 ml Omegaven for a patient with a body weight of 70 kg.
Maximum infusion rate: The infusion rate should not exceed 0.5 ml Omegaven/kg body weight/hour corresponding to 0.05 g fish oil/kg body weight/hour. The maximum infusion rate should be strictly adhered to, otherwise a severe increase in the serum triglyceride concentration can be observed.
Omegaven should be administered simultaneously with other fat emulsions. On the basis of a recommended total daily lipid intake of 1 – 2 g/kg body weight, the fish oil portion from Omegaven should constitute 10 – 20% of this intake.
Method of administration
– For infusion via central or peripheral vein.
– Containers should be shaken before use.
– When Omegaven is to be administered with other infusion solutions (eg amino acid solutions, cabohydrate solutions) via a common infusion line (by-pass, y-tube), the compatibility of the solutions/emulsions used must be ensured.
Duration of administration: The duration of administration should not exceed 4 weeks.

Parenteral nutrition supplementation with long chain Omega-3-fatty-acids, especially eicosaptentaenoic and docosahexaenoic acids when oral or enteral nutrition is impossible, insufficient or contraindicated.

Severe haemorrhagic disorders. Certain acute and life-threatening conditions such as:
– collapse and shock
– recent cardiac infarction
– stroke
– embolism
– undefined coma status
Due to lack of experience Omegaven should not be administered in patients with severe liver or renal insufficiency. Omegaven should not be used in premature infants, newborns, infants and children due to limited experience.
General contra-indications for parenteral nutrition:
– hypokalaemia
– hyperhydration
– hypotonic dehydration
– unstable metabolism
– acidoses Omegaven must not be administered to patients known to be allergic to fish or egg protein.

Omegaven should be given with caution to patients with an impaired lipid metabolism and uncontrolled diabetes mellitus.
The serum triglyceride level should be monitored daily. Checks of blood glucose profiles, acid base metabolism, serum electrolytes, fluid balance, blood count and bleeding time in patients treated with anticoagulants must be carried out regularly. The serum triglyceride concentration should not exceed 3 mmol/l during the infusion of fat emulsions.

Slight rise in body temperature, heat sensation and/or cold sensations, chills, flush or cyanosis, lack of appetite, nausea, vomiting, dyspnea, headache, pain in the chest, back and loins, bone-pain, priapism (in very rare cases), increase or decrease in blood pressure, anaphylactic reactions (e.g. erythema).
For full details see prescribing information.

The infusion of Omegaven can cause a prolonged bleeding time and an inhibited platelet aggregation. Therefore, Omegaven should be administered with caution to patients requiring anticoagulant therapy even with regard to a possible reduction of anticoagulants.

There is no evidence on the safety of this medicine during pregnancy or breastfeeding. This medicine should be used during pregnancy and breastfeeding only if strictly necessary.

Overdose leading to fat overload syndrome may occur when the triglyceride level during lipid infusion rises above 3 mmol/l, acutely, as a result of too rapid infusion rate, or chronically at recommended rates of infusion in association with a change in the patient´s clinical condition e.g. renal function impairment or infection.
Overdose may lead to side-effects.
In these cases, the lipid infusion should be stopped or, if necessary, continued at a reduced dosage. The administration of fat also has to be stopped if a marked increase in blood glucose levels occur during infusion of Omegaven. A severe overdose of Omegaven without simultaneous administration of a carbohydrate solution, may lead to metabolic acidosis.