Adverse reactions : תופעות לוואי

4.8    Undesirable effects

The following listing includes a number of systemic adverse reactions that may be associated with the use of Lipofundin MCT/LCT 20%. Under the conditions of correct use, in terms of dosing, monitoring, observation of safety restrictions and instructions, most of them are very rare (< 1/10,000).

Listing of undesirable effects

Undesirable effects are listed according to their frequencies as follows: Very common (≥ 1/10)
Common        (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare          (≥ 1/10,000 to < 1/1,000)
Very rare     (< 1/10,000)
Not known     (frequency cannot be estimated from the available data) 
Blood and lymphatic system disorders
Very rare:   Hypercoagulability
Not known: Leucopenia, thrombocytopenia

Immune system disorders
Very rare:  Allergic reactions (e.g. anaphylactic reactions, dermal eruptions, laryngeal, oral and facial oedema)

Metabolism and nutrition disorders
Very rare:   Hyperlipidaemia, hyperglycaemia, metabolic acidosis, ketoacidosis The frequency of these adverse reactions is dose-dependent and may be higher under conditions of absolute or relative overdose.

Nervous system disorders
Very rare:   Headache, drowsiness

Vascular disorders
Very rare:    Hypertension or hypotension, flush
Respiratory, thoracic and mediastinal disorders
Very rare:     Dyspnoea, cyanosis
Gastrointestinal disorders
Very rare:    Nausea, vomiting, loss of appetite

Hepatobiliary disorders
Not known: Cholestasis

Skin and subcutaneous tissue disorders
Very rare:   Erythema, sweating
Musculoskeletal and connective tissue disorders
Very rare:   Pain in the back, bones, chest and lumbar region

General disorders and administration site conditions
Very rare:    Elevated body temperature, feeling cold, chills, fat overload syndrome (see below).

If adverse reactions occur, the infusion of Lipofundin MCT/LCT 20% must be stopped or, if necessary, continued at a reduced dosage.

If the infusion is restarted, the patient must be carefully monitored, especially at the beginning, and serum triglycerides should be determined at short intervals.

Information on particular undesirable effects

Nausea, vomiting, lack of appetite and hyperglycaemia are symptoms related to conditions constituting an indication for parenteral nutrition and may sometimes be associated with parenteral nutrition.

Fat overload syndrome
Overdose of lipid emulsion or impaired capacity to eliminate triglycerides can lead to “fat overload syn-drome”. 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 diseases.
This syndrome may also appear during severe hypertriglyceridaemia, 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 hyperlipidaemia, fever, fat infiltration, hepatomegaly with or without icterus, splenomegaly, anaemia, leukopenia, thrombocytopenia, coagulation disorder, haemolysis 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 Lipofundin MCT/LCT 20% must be discon-tinued immediately.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form (https://sideeffects.health.gov.il).