Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Common              Uncommon               Rare
≥ 1/100 to < 1/10   ≥ 1/1,000 to < 1/100   ≥ 1/10,000 to < 1/1,000 Cardiac disorders                                                  Tachycardia Respiratory, thoracic                                              Dyspnoea and mediastinal disorders
Gastrointestinal                            Lack of appetite,
disorders                                   nausea, vomiting
Metabolism and                              Elevated plasma nutrition disorders                         levels of liver enzymes


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Vascular disorders                                              Hypotension, hypertension
General disorders     Slight increase in   Chills, dizziness,   Hypersensitivity and administration    body temperature     headache             reactions (e.g.
site conditions                                                 anaphylactic or 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 Extra Nitrogen 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 characterized 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 Extra Nitrogen 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/
In addition, suspected adverse events can be reported to the Registration Holder's Patient Safety Unit at: drugsafety@neopharmgroup.com