Special Warning : אזהרת שימוש

4.4     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. Special caution should be taken in patients with a marked risk for hyperlipidema (e.g. patients with high lipid dosage, 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 dosage or cessation of the lipid emulsion should be considered if serum or plasma triglyceride concentrations during or after infusion exceed 3 mmol/L. An overdose may lead to fat overload syndrome, see section 4.8.
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.

Smoflipid 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 Smoflipid. 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.

Smoflipid 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 trace elements and/or vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products. When used in neonates and children below 2 years, Smoflipid should be protected from ambient light until administration is completed (see section 4.2, 6.3 and 6.6).

High levels of lipids in plasma may interfere with some laboratory blood tests, e.g.
haemoglobin.

Smoflipid contains up to 5 mmol sodium per 1000 ml. To be taken into consideration by patients on a controlled sodium diet.

The addition of other medicaments or substances to Smoflipid should generally be avoided unless compatibility is known (see 6.2 and 6.6).

Effects on Driving

4.7   Effects on ability to drive and use machines
Not relevant.