Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as follows: very common ≥1/10 (≥10%); common ≥1/100 and <1/10 (≥1% and <10%); uncommon ≥1/1000 and <1/100 (≥0.1% and <1%); rare ≥1/10,000 and <1/1000 ( ≥0.01% and <0.1%); very rare <1/10,000 (< 0.01%) and not known (cannot be estimated from the available data).

Infections and Infestations
Common             Sepsis, septicaemia (mostly related to delivery system for Flolan)1 Blood and Lymphatic System Disorders
Common             Decreased platelet count, bleeding at various sites (e.g. pulmonary, gastrointestinal, epistaxis, intracranial, post-procedural,
retroperitoneal)
Unknown            Splenomegaly, Hypersplenism
Endocrine Disorders
Very rare          Hyperthyroidism
Psychiatric Disorders
Common             Anxiety, nervousness
Very rare          Agitation
Nervous System Disorders
Very common        Headache
Cardiac Disorders
Common             Tachycardia2, bradycardia3
Not known          High output cardiac failure
Vascular Disorders
Very common        Facial flushing (seen even in the anaesthetised patient) Common             Hypotension
Very rare          Pallor


Not known            Ascites
Respiratory, thoracic and mediastinal disorders
Unknown              Pulmonary oedema
Gastrointestinal Disorders
Very common          Nausea, vomiting, diarrhoea
Common               Abdominal colic, sometimes reported as abdominal discomfort Uncommon             Dry mouth
Skin and Subcutaneous Tissue Disorders
Common               Rash
Uncommon             Sweating
Musculoskeletal and Connective Tissue Disorders
Very common          Jaw pain
Common               Arthralgia
General Disorders and Administration Site Conditions
Very common          Pain (unspecified)
Common               Pain at the injection site*, chest pain
Rare                 Local infection*
Very rare            Erythema over the infusion site*, occlusion of the long i.v.
catheter*, lassitude, chest tightness
Investigations
Unknown              Blood glucose increased
* Associated with the delivery system for Flolan
1
Catheter-related infections caused by organisms not always considered pathogenic (including micrococcus) have been reported.
2
Tachycardia has been reported as a response to Flolan at doses of 5 nanograms/kg/min and below.
3
Bradycardia, sometimes accompanied by orthostatic hypotension, has occurred in healthy volunteers at doses of Flolan greater than 5 nanograms/kg/min. Bradycardia associated with a considerable fall in systolic and diastolic blood pressure has followed i.v. administration of a dose of Flolan equivalent to 30 nanograms/kg/min in healthy conscious volunteers.

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
Additionally, you should also report to GSK Israel (il.safety@gsk.com).