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 Lipidem 200mg/ml. 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).

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       (cannot be estimated from the available data)

Blood and lymphatic system disorders
Very rare:      Hypercoagulation
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, metabolic acidosis
The frequency of these adverse reactions is dose-dependent and may be higher under conditions of absolute or relative overdose.
Very rare:      Hyperglycaemia

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

Skin and subcutaneous tissue disorders
Very rare:       Erythema, sweating
Hepatobiliary disorders
Not known:       Cholestasis

Musculoskeletal and connective tissue disorders
Rare:   Back, bones, chest and lumbar region pain

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

Should adverse reactions occur, the infusion must be stopped.

Should the triglyceride level rise to above 11.4 mmol/l (1000 mg/dl) during infusion, the infusion must be stopped. With levels above 4.6 mmol/l (400 mg/dl), the infusion may be continued at a reduced dosage (see section 4.4).

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

Information on particular undesirable effects
Nausea, vomiting and lack of appetite are symptoms often related to conditions for which parenteral nutrition is indicated, and may be associated with parenteral nutrition at the same time.

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 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, leucopenia, 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 Lipidem 200mg/ml must be discontinued 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.