Posology : מינונים

4.2   Posology and method of administration

Posology
The dosage has to be adapted to the patients’ individual requirements.

Maximum daily doses should only be administered after stepwise increase with careful monitoring of the tolerance of the infusions.

The utilisation of intravenous lipids depends on e.g. the severity of underlying disease, body weight, gestational and postnatal age and specific body functions.

Depending on energy requirements, the following daily doses are recommended: 
Adults

The usual dose is 0.7 to 1.5 g lipids/kg body weight (b.w.) per day. A maximum dose of 2.0 g lipids/kg b.w./d, for instance when energy requirements are high or fat utilisation is increased (e.g. oncology patients), should not be exceeded For long-term home parenteral nutrition treatment (> 6 months) and in patients with short bowel syndrome the provision of intravenous lipids should not exceed 1.0 g/kg b.w./d.
For a patient weighing 70 kg a daily dose of 2.0 g/kg b.w./d corresponds to a maximum daily dose of 700 ml Lipidem 200mg/ml.

Paediatric population

A gradual increase of lipid intake in increments of 0.5 – 1.0 g/kg b.w./d may be beneficial regarding the possibility to monitor the increase of the plasma triglyceride level and prevent hyperlipidaemia.

Preterm newborn infants, term newborn infants, infants and toddlers It is recommended not to exceed a daily dose of 2.0 – 3.0 g/kg b.w./d of lipids.
In preterm newborn infants, term newborn infants, infants and toddlers, the daily dose of lipids should be infused continuously over about 24 hours.

Children and adolescents
It is recommended not to exceed a daily lipid dose of 2.0 – 3.0 g/kg b.w./d.
      Elderly patients
Basically the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age.

Patients with diabetes mellitus, impaired cardiac or renal function See section 4.4.

Patients with hepatic impairment
See section 4.4 (‘(‘Patients with impaired lipid metabolism’).

Infusion rate
The infusion should be administered at the lowest possible infusion rate. During the first 15 minutes the infusion rate should only be 50% of the maximum infusion rate to be used.
The patient should be monitored closely for the occurrence of adverse reactions.

Maximum infusion rate

Adults
Up to 0.15 g/kg b.w./h lipids.
For a patient weighing 70 kg this corresponds to a maximum infusion rate of 52.5 ml per hour Lipidem 200mg/ml. The amount of lipids administered then is 10.5 g per hour.

Preterm newborn infants, term newborn infants, infants and toddlers Up to 0.15 g/kg b.w./h lipids.

Children and adolescents
Up to 0.15 g/kg b.w./h lipids.

Method of administration
Intravenous use.
Lipid emulsions are suitable for peripheral venous administration and can also be administered separately via peripheral veins as part of total parenteral nutrition.
The Y- or the bypass connector should be placed as close to the patient as possible if lipid emulsions are co-administered with amino acid and carbohydrate solutions.
For further instructions on handling of the medicinal product before administration, see section 6.6.

When used in neonates and children below 2 years, the solution (in bottles and administration sets) should be protected from light exposure until administration is completed (see sections 4.4, 6.3 and 6.6).

Duration of treatment
As clinical experience with long-term use of Lipidem 200mg/ml is limited, it should normally not be administered for longer than one week. If parenteral nutrition with lipid emulsions is further indicated, Lipidem 200mg/ml can be administered over longer periods provided appropriate monitoring is employed.