Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The frequency categories associated with the adverse events below are estimates. For most events, suitable data for estimating incidence were not available. In addition, adverse events may vary in their incidence depending on the indication.
The following convention has been used for the classification of undesirable effects in terms of frequency:− Very common ≥ 1/10, common ≥ 1/100 and < 1/10, uncommon ≥ 1/1,000 and < 1/100, rare ≥ 1/10,000 and < 1/1,000, very rare < 1/10,000.
Blood and lymphatic system disorders:
Uncommon: decreases in haematological indices (anaemia, thrombocytopenia, leukopenia).


Immune system disorders:
Very rare: anaphylaxis.

Psychiatric and nervous system disorders:
Very rare: headache, dizziness, agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma.
The above events are generally reversible and usually reported in patients with renal impairment or with other predisposing factors (see 4.4 Special Warnings and Precautions for Use).


Vascular disorders:
Common: phlebitis.

Respiratory, thoracic and mediastinal disorders:
Very rare: dyspnoea.

Gastrointestinal disorders:
Common: nausea, vomiting.
Very rare: diarrhoea, abdominal pain.


Hepato-biliary disorders:
Common: reversible increases in liver-related enzymes.
Very rare: reversible increases in bilirubin, jaundice, hepatitis.

Skin and subcutaneous tissue disorders:
Common: pruritus, urticaria, rashes (including photosensitivity).
Very rare: angioedema.

Renal and urinary disorders:
Common: increases in blood urea and creatinine.
Rapid increases in blood urea and creatinine concentrations are believed to be related to the peak plasma concentrations and the state of hydration of the patient. To avoid this effect the drug should not be given as an intravenous bolus injection but by slow infusion over a one-hour period.
Very rare: renal impairment, acute renal failure and renal pain.
Adequate hydration should be maintained. Renal impairment usually responds rapidly to rehydration of the patient and/or dosage reduction or withdrawal of the drug.
Progression to acute renal failure however, can occur in exceptional cases.
Renal pain may be associated with renal failure and crystalluria.


General disorders and administration site conditions:
Very rare: fatigue, fever, local inflammatory reactions
Severe local inflammatory reactions sometimes leading to breakdown of the skin have occurred when Zovirax I.V. has been inadvertently infused into extracellular tissues.

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)