Blood and lymphatic system disorders.
Not known: Infusion of glucose sodium chloride solution may lead to fluid and electrolyte imbalances such as hypokalaemia, hypomagnesaemia and hypophosphataemia. Hypokalaemia may complicate glucose infusions, especially when combined with insulin in the treatment of diabetic ketoacidosis. Other adverse effects may be sodium retention, oedema.
Cardiac disorders: Not known: Hypertension, tachycardia.
Gastrointestinal disorders: Not known: Gastrointestinal effects.
General disorders and administration site conditions: Not known: Prolonged intravenous infusion may lead to venous irritation and thrombophlebitis at the infusion site.
Post Marketing Adverse reactions: Metabolism and nutrition disorders – severe hyponatraemia, which could lead to death, has been reported.
In the event of adverse reaction, stop infusion immediately.
Blood and lymphatic system disorders.
Not known: Infusion of glucose sodium chloride solution may lead to fluid and electrolyte imbalances such as hypokalaemia, hypomagnesaemia and hypophosphataemia. Hypokalaemia may complicate glucose infusions, especially when combined with insulin in the treatment of diabetic ketoacidosis. Other adverse effects may be sodium retention, oedema.
Cardiac disorders: Not known: Hypertension, tachycardia.
Gastrointestinal disorders: Not known: Gastrointestinal effects.
General disorders and administration site conditions: Not known: Prolonged intravenous infusion may lead to venous irritation and thrombophlebitis at the infusion site.
Post Marketing Adverse reactions: Metabolism and nutrition disorders – severe hyponatraemia, which could lead to death, has been reported.
In the event of adverse reaction, stop infusion immediately.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:
For United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
For Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie