Product Dossier

VIAFLO

Product Dossier for VIAFLO (sodium chloride, Baxter Healthcare). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

VIAFLO 5% Glucose Intravenous (IV) Infusions are sterile, non-pyrogenic parenteral solutions containing glucose (5%) in Water for Injections. They do not contain an antimicrobial agent or added buffer, and have a pH of 3.5 — 6.5. VIAFLO 5% Glucose IV Infusions are isotonic solutions. The solution is a clear colourless liquid for Intravenous Infusion.

Approved indications VIAFLO 5% Glucose IV infusions are mainly indicated:

— Whenever non-electrolyte fluid replacement is required — As a vehicle for drug delivery, provided that the added components are compatible with glucose

Dosing overview

The infusion rate and volume of the VIAFLO 5% Glucose IV Infusions are dependent upon the age, weight, concomitant therapy, clinical and metabolic conditions of the patient as well as laboratory determinations. VIAFLO 5% Glucose IV Infusion may be administered intravenously to healthy individuals at a rate of 0.5 g/kg per hour without producing glycosuria; the maximum infusion rate should not exceed 0.8 g/kg per hour.

Key safety warnings

Hypersensitivity/infusion reactions, including anaphylactic/anaphylactoid reactions, have been reported with glucose intravenous infusions. The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. The administration of VIAFLO 5% Glucose IV Infusions can cause fluid and/or solute overloading resulting in dilution of the serum electrolyte concentrations, over-hydration, congested states, or pulmonary oedema. Depending on the volume and rate of infusion and depending on a patient's underlying clinical condition and capability to metabolise glucose, intravenous administration of glucose can cause hyperosmolality, osmotic diuresis and dehydration; hypoosmolality; electrolyte disturbances such as hypo- or hyperosmotic hyponatraemia, hypokalaemia, hypophosphataemia, and hypomagnesaemia; and overhydration/hypervolaemia and congested states, including pulmonary congestion and oedema. Monitoring of serum sodium is particularly important. High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatraemia. Rapid administration of glucose solutions may produce substantial hyperglycaemia and a hyperosmolar syndrome. In order to avoid hyperglycaemia the infusion rate should not exceed the patient's ability to utilise glucose. To reduce the risk of hyperglycaemia-associated complications, the infusion rate must be adjusted and/or insulin administered if blood glucose levels exceed levels considered acceptable for the individual patient.

Contraindications

VIAFLO 5% Glucose IV Infusions are contraindicated in patients who have had head trauma within 24 hours with blood glucose concentrations being closely monitored during intracranial hypertension; with known hypersensitivity to the product; with known allergy to corn or corn products, because cornstarch is used as raw material for glucose production; and with clinically significant hyperglycaemia. Avoid use after an ischaemic stroke episode as under this condition, the induced lactic acidosis aggravates the recovery of the brain damage tissue.

Regulatory history

VIAFLO 5% Glucose was first approved on 30 September 1991. VIAFLO 5% Glucose Intravenous Infusion in multiple pack sizes (50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags) was first listed on the ARTG on 2018-03-13 under licence category RE.