Adverse reactions : תופעות לוואי

4.8. Undesirable effects

Adverse drug reactions (ADRs) that occurred after administration of ClinOleic 20% in clinical trials and those from post-marketing reports are presented. ClinOleic was administered to 274 adult patients in the clinical trials. The most frequent ADRs noted for ClinOleic 20% in clinical trials were nausea/vomiting, which occurred in more than 2% of the patients.

Frequencies of ADRs are presented using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000); and unknown (cannot be estimated from the available data).

Clinical Trial and Post-Marketing Adverse Drug Reactions Reported for ClinOleic 20% System Organ Class (SOC)                 MedDRA Preferred Term             Frequency BLOOD AND LYMPHATIC                      Leukopaenia                       Uncommon SYSTEM DISORDERS                         Thrombocytopaenia                 Unknown IMMUNE SYSTEM DISORDERS                  Hypersensitivity                  Unknown Hyperglycaemia                    Common
METABOLISM AND NUTRITION
DISORDERS                                Hypoproteinaemia                  Common Hyperlipidaemia†                  Common
Mean arterial pressure
Common decreased
VASCULAR DISORDERS                       Circulatory collapse              Uncommon Hypotension                       Uncommon
Hot flush                         Uncommon
RESPIRATORY, THORACIC AND
Dyspnoea                          Uncommon
MEDIASTINAL DISORDERS
Nausea/Vomiting                   Common
GASTROINTESTINAL                         Abdominal distension              Common DISORDERS                                Abdominal pain                    Uncommon Epigastric discomfort             Uncommon
Cholestasis                       Common
Cytolytic hepatitis               Uncommon
HEPATOBILIARY DISORDERS
Cholecystitis                     Unknown
Cholelithiasis                    Unknown
MUSCULOSKELETAL AND                      Muscle spasms                     Common CONNECTIVE TISSUE AND
Back pain                         Uncommon
BONE DISORDERS
SKIN AND SUBCUTANEOUS
Pruritus                          Unknown
DISORDERS
GENERAL DISORDERS AND
ADMINISTRATION SITE                      Chills                            Uncommon CONDITIONS
Blood bilirubin increased**       Common

Liver function test abnormal‡     Common
INVESTIGATIONS
Pancreatic enzyme increased       Uncommon

Blood triglycerides increased     Common
†includes reports of Hypertriglyceridemia
‡includes reports of Hepatic Function Abnormal, Hepatic Enzyme Increased, Blood Alkaline Phosphatase Increased, Gamma Glutamyl Transferase Increased, Blood Alkaline Phosphatase Abnormal, Gamma Glutamyl Transferase Abnormal
** Includes Bilirubin Conjugated Increased

Fat overload syndrome (very rare): see section 4.4 for more information.
During long-term parenteral nutrition, the following adverse reactions have been observed: - increase of alkaline phosphatase, transaminases and bilirubin,
- rarely: hepatomegaly and icterus,
- moderate thrombocytopenia.
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