Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Undesirable effects observed during the administration of fat emulsions: 
Common            Uncommon             Rare                Very rare (≥1/100 to <1/10) (≥1/1000 to          (≥1/10,000 to       (<1/10,000) <1/100)              <1/1000)
Vascular                                                  Hypotension, disorders                                                 hypertension Respiratory,                                              Dyspnoea thoriacic and mediastinal disorders
Gastrointestinal                      Lack of appetite,
disorders                             nausea, vomiting
Reproductive                                                                  Priapism system and breast disorders
General            Slight increase in Chills              Hypersensitivity- disorders and      body                                   reactions (e.g.
administration     temperature                            anaphylactic or site conditions                                           anaphylactoid reactions, skin rash, urticaria,
flush, headache),
heat or cold sensation,
paleness,
cyanosis, pain in the neck, back,
bones, chest and loins

Should these side-effects occur or should the triglyceride level during infusion rise above 3 mmol/l, the infusion of Smoflipid should be stopped or, if necessary, continued at a reduced dosage.

Smoflipid should always be a part of a complete parenteral nutritional treatment including amino acids and glucose. Nausea, vomiting and hyperglycemia are symptoms related to conditions indicating parenteral nutrition and may sometimes be associated with parenteral nutrition.

Monitoring of triglycerides and blood glucose levels are recommended to avoid elevated levels, which may be harmful.

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 illnesses. This syndrome may also appear during severe hypertriglyceridemia, 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 hyperlipemia, fever, fat infiltration, hepatomegaly with or without icterus, splenomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorder, hemolysis 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 Smoflipid should be discontinued.


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/ and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com.