Glukoza 10% viaflo

Overdose

Overdose of Glukoza 10% Viaflo 20% may lead to hyperglycaemia and glycosuria leading to dehydration, hyperosmolar coma and death.

The blood levels of Glukoza 10% Viaflo can be reduced by slow infusion of insulin. Careful monitoring of blood Glukoza 10% Viaflo levels would be necessary.

Incompatibilities

Glukoza 10% Viaflo solutions which do not contain electrolytes, should not be administered concomitantly with blood through the same infusion set, because of the possibilities of agglomeration.

Undesirable effects

Very common (> 1/10); Common (> 1/100 to < 1/10); Uncommon (> 1/1,000 to < 1/100); Rare (> 1/10,000 to < 1/1,000); Very rare (<1/10,000), Not known (cannot be estimated from the available data)

System Organ Class (SOC)

Adverse reaction (MedDRA term)

Frequency

Metabolism and nutrition disorders

Hospital acquired hyponatraemia *

Hyperglycaemia**

Hypokalaemia

Hypophosphataemia

Hypomagnesaemia

Fluid and electrolyte imbalance.

Not known

Nervous system disorders

Hyponatraemic encephalopathy*

Not known

General disorders and administration site conditions

Pain at the injection site

Vein irritation

Venous thrombosis

Phlebitis

Not known

* Hospital acquired hyponatraemia may cause irreversible brain injury and death due to development of acute hyponatraemic encephalopathy.

** Hyperglycaemia (possibly indicated by mental confusion or loss of consciousness) and glycosuria may occur as a result of the rate of administration or metabolic insufficiency. If undetected and untreated hyperglycaemia can lead to dehydration, hyperosmolar coma and death.

The administration of Glukoza 10% Viaflo without adequate levels of thiamine may precipitate overt deficiency states e.g. Wernicke's encephalopathy. Sodium retention, oedema, pulmonary oedema and congestive heart failure may be induced in patients with severe under-nutrition.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Preclinical safety data

No further information other than that which is included in the Summary of Product Characteristics.

Pharmacotherapeutic group

Solutions for parenteral nutrition, Carbohydrates

Pharmacodynamic properties

Pharmacotherapeutic group: Solutions for parenteral nutrition, Carbohydrates

ATC code: B05BA03

The metabolism of Glukoza 10% Viaflo is an energy source for the body.

Pharmacokinetic properties

Glukoza 10% Viaflo is rapidly metabolised into carbon dioxide and water

Effects on ability to drive and use machines

None known.

Special precautions for disposal and other handling

Use as directed by the physician.

Glukoza 10% Viaflo 20% is provided in a concentration that is ready for administration.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.