Adverse reactions : תופעות לוואי

4.8      Undesirable effects
Common                       Uncommon                     Rare
≥ 1/100 to <1/10             ≥ 1/1000 to <1/100           ≥ 1/10000 to <1/1000 Cardiac disorders                                                                      Tachycardia Respiratory, thoracic and                                                               Dyspnoea mediastinal disorders
Gastrointestinal disorders                                Lack of appetite, nausea, vomiting
Metabolism and nutrition                                  Elevated plasma levels of disorders                                                 liver enzymes Vascular disorders                                                                      Hypotension, hypertension
General disorders and        Slight increase in body      Chills, dizziness,            Hypersensitivity-reactions administration site          temperature                  headache                      (e.g. anaphylactic or 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 the infusion of SmofKabiven should be stopped or, if necessary, continued at a reduced dosage.

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 lipid 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, lipid 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 lipid emulsion is discontinued.

Excess of amino acid infusion
As with other amino acid solutions, the amino acid content in SmofKabiven may cause undesirable effects when the recommended infusion rate is exceeded. These effects are nausea, vomiting, shivering and sweating. Amino acid infusion may also cause a rise in body temperature. With an impaired renal function, increased levels of nitrogen containing metabolites (e.g. creatinine, urea) may occur.

Excess of glucose infusion
If the glucose clearance capacity of the patient is exceeded, hyperglycaemia will develop.

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