GLUCOSE 5% BP Solution for infusion Ref.[8099] Active ingredients: Glucose

Posology

Adults, the Elderly and Children

The concentration and dosage of Glucose 5% intravenous infusion is determined by several factors including the age, weight and clinical condition of the patient. Serum-glucose concentrations may need to be carefully monitored.

Fluid balance, serum glucose, serum sodium and other electrolytes should be monitored before and during administration, especially in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs due to the risk of hyponatraemia. Monitoring of serum sodium is particularly important for physiologically hypotonic fluids. <Product name> may become extremely hypotonic after administration due to glucose metabolization in the body (see sections 4.4, 4.5 and 4.8).

The recommended dosage for treatment of carbohydrate and fluid depletion is:

• for adults: 500 ml to 3 litres/24h.
• for babies and children:
  • 0-10 kg body weight: 100 ml/kg/24h.
  • 10-20 kg body weight: 1000 ml + 50 ml/kg over 10 kg/24h.
  • >20 kg body weight: 1500 ml + 20 ml/kg over 20 kg/24h.

The infusion rate depends on the patient’s clinical condition.

Infusion rate should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycaemia. Therefore, the maximum dose ranges from 5mg/kg/min for adults to 10-18 mg/kg/min for babies and children depending on the age and the total body mass.

The recommended dosage when used as a vehicle or diluent ranges from 50 to 250 ml per dose of medicinal product to be administered.

When Glucose 5% is used as a diluent for injectable preparations of other drugs, the dosage and the infusion rate will be principally dictated by the nature and the dose regimen of the prescribed drug.

Paediatric population

The infusion rate and volume depends on the age, weight clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in paediatric intravenous fluid therapy.

Method of administration

The solution is for administration by intravenous infusion (peripheral or central vein).

When the solution is used for dilution and delivery of therapeutic additives for administration by intravenous infusion, the direction for use with additive therapeutic substances will dictate the appropriate volumes for each therapy.

Glucose 5% intravenous infusion is a isosmotic solution.

Please see section 3 for the information about the osmolarity of the solution.

Precautions to be taken before handling or administering the medicinal product

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if the solution is clear, without visible particles and the container is undamaged. Administer immediately following the insertion of infusion set.

The solution should be administered with sterile equipment using aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.

Electrolyte supplementation may be indicated according to the clinical needs of the patient.

Additives may be introduced before or during infusion through the injection site.

When introducing additives, the final osmolarity of solutions need to be checked. Administration of hyperosmolar solutions may cause venous irritation and phlebitis. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored.

Please see section 4.4 for the risk of air embolism.

Prolonged administration or rapid infusion of large volumes of Glucose 5% may cause hyperosmolarity and hyponatraemia, dehydration, hyperglycaemia, hyperglycosuria, osmotic diuresis (due to the hyperglycaemia) and water intoxication and oedema. Severe hyperglycaemia and hyponatraemia may be fatal (see sections 4.4 and 4.8).

In case of suspected overdose, treatment with Glucose 5% must be stopped immediately. Management of overdose is symptomatic and supportive, with appropriate monitoring.

Shelf life

Shelf life as packaged:

50 ml bag: 15 months
100 ml bag: 2 years
250 and 500 ml bags: 2 years
1000 ml bags: 3 years

In-use shelf life: Additives

Chemical and physical stability of any additive at the pH of Glucose 5% in the Viaflo container should be established prior to use.

From a microbiological point of view, the diluted product must be used immediately unless dilution has taken place in controlled and validated aseptic conditions. If not used immediately, in-use storage times and conditions are the responsibility of the user.

50 and 100 ml bags: Do not store above 30°C.

250, 500 and 1000 ml bags: This medicinal product does not require any special storage conditions.

Bag sizes: 50, 100, 250, 500 or 1000 mL.

The bags known as Viaflo are composed of polyolefin/polyamide co-extruded plastic (PL-2442).

The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene.

Pack sizes:

• 50 bags of 50 ml per carton
• 75 bags of 50 ml per carton.
• 1 bag of 50 ml
• 50 bags of 100 ml per carton
• 1 bag of 100 ml
• 30 bags of 250 ml per carton
• 1 bag of 250 ml
• 20 bags of 500 ml per carton
• 1 bag of 500 ml
• 10 bags of 1000 ml per carton
• 1 bag of 1000 ml

Not all pack size may be marketed.

Discard after single use.

Discard any unused portion.

Do not store solutions containing additives.

Do not reconnect partially used bags.

Do not remove unit from overwrap until ready for use. The inner bag maintains the sterility of the product.

When introducing additives to Glucose 5% solution aseptic technique must be used.

Mix the solution thoroughly when additives have been introduced.

Opening:

• Remove the Viaflo container from the overpouch just before use.
• Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution, as sterility may be impaired.
• Check the solution for limpidity and absence of foreign matters. If solution is not clear or contains foreign matters, discard the solution.

Preparation for administration:

Use sterile material for preparation and administration.

• Suspend container from eyelet support.
• Remove plastic protector from outlet port at bottom of container:
  • grip the small wing on the neck of the port with one hand,
  • grip the large wing on the cap with the other hand and twist,
  • the cap will pop off.
• Use an aseptic method to set up the infusion
• Attach administration set. Refer to complete directions accompanying set for connection, priming of the set and administration of the solution.

Techniques for injection of additive medications:

Warning: Additives may be incompatible.

To add medication before administration:

• Disinfect medication site.
• Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture resealable medication port and inject.
• Mix solution and medication thoroughly. For high-density medication such as potassium chloride, tap the ports gently while ports are upright and mix.

Caution: Do not store bags containing added medications.

To add medication during administration:

• Close clamp on the set.
• Disinfect medication site.
• Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture resealable medication port and inject.
• Remove container from IV pole and/or turn to an upright position.
• Evacuate both ports by tapping gently while the container is in an upright position.
• Mix solution and medication thoroughly.
• Return container to in use position, re-open the clamp and continue administration.