Dextrose 5% is indicated for fluid replacement, administered alone or in regimens with electrolytes or additives known to be compatible with 5% Dextrose Injection.
Medium for intravenous administration of medicinal products known to be compatible with 5% Dextrose Injection.

For intravenous infusion under medical supervision. Single use only.
To avoid dehydration in a healthy adult or in patients with no complicating factors such as fever or excessive fluid losses, daily fluid requirements are 1.5 to 2.5 liters.
The volume of Dextrose solution needed to replenish deficits will vary with body weight, complementary treatment, severity of the clinical condition and hydration status of the patient, but in adults will usually lie between 2 and 10 liters.

The pathophysiological response to dehydration, to electrolyte loss and to Dextrose infusion will vary with the age of the patient being treated and this  hould be taken into account during rehydration therapy.
There is no recommended dose as this is a matter for clinical judgment and laboratory assessment in each case. The dose range is typically 500 – 3000 ml in a 24 hour period and typical maximum rates are 800 mg/kg/hr or 600 ml/hr.

The rate of infusion should be sufficiently slow to allow detection of osmotic diuresis.
Prior to and during infusion, serum and/or urinary electrolytes and Dextrose should be monitored to assess the nature and severity of fluid depletion and electrolyte imbalance.

Close monitoring of patients with diabetes mellitus, and in patients with renal failure, is necessary during dextrose infusion.
Dextrose infusions are incompatible with blood for transfusion as haemolysis or clumping can occur; do not administer through the same infusion equipment as blood or blood components for transfusion (either before, during or after their administration).
Use with care in patients who have suffered an acute ischaemic stroke.
Hyponatraemia:
Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, postoperative stress, infections, burns, and CNS diseases),

patients with heart-, liver- and kidney diseases and patients exposed to vasopressin agonists (see section 4.5) are at risk of acute hyponatraemia upon infusion of hypotonic fluids.
Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (brain oedema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain oedema are at particular risk of severe, irreversible and life-threatening brain injury. Children, women in the fertile age and patients with reduced cerebral compliance (e.g. meningitis, intracranial bleeding, and cerebral contusion) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

compatibility of medicinal products with 5% Dextrose Injection before administration
with the solution. See section 6.2 Incompatibilities.
Drugs leading to an increased vasopressin effect
The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and increase the risk of hospital acquired
hyponatraemia following inappropriately balanced treatment with i.v. fluids.
• Drugs stimulating vasopressin release, e.g.:
Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-N-methamphetamine, ifosfamide,
antipsychotics, narcotics
• Drugs potentiating vasopressin action, e.g.:
Chlorpropamide, NSAIDs, cyclophosphamide
• Vasopressin analogues, e.g:
Desmopressin, oxytocin, vasopressin, terlipressin
Other medicinal products increasing the risk of hyponatraemia also include diuretics
in general and antiepileptics such as oxcarbazepine.
Check compatibility of medicinal products with 5% glucose before administration with the solution

It is particularly important to avoid maternal hyperglycaemia during intravenous dextrose infusion in the perinatal period in view of the possibility of inducing neonatal hypoglycaemia.

There is no information on the effects of 5% Dextrose Injection solution on the ability to operate an automobile or other heavy machinery.

 The frequency of adverse events listed below is defined using the following convention:
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).
Metabolism and nutrition disorders:
Not known: fluid and electrolyte disturbances including hypokalaemia, hypomagnesaemia and
hypophosphataemia, hyperglycaemia, glycosuria. Hypokalaemia may complicate dextrose
infusions, especially when combined with insulin in the treatment of diabetic ketoacidosis.
Not known: Hospital Acquired Hyponatraemia*
Nervous system disorders
Not known: Hyponatraemic encephalopathy*
*Hospital acquired hyponatraemia may cause irreversible brain injury and death due to
development of acute hyponatraemic encephalopathy

Not known: Irritation and discomfort at the site of infusion.
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.
Note: To report any side effects please contact;
National Pharmacovigilance Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free Phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

Administration of excessive amounts of 5% Dextrose Injection may result in fluid overload and water intoxication.
Severe over-infusion is usually limited to infusion with higher concentrations of dextrose solutions,

which may cause. plasma hyperosmolality and osmotic diuresis. Treatment is symptomatic.

Pharmacotherapeutic group: electrolyte with carbohydrate.
ATC code: B05BB02
 Dextrose is rapidly absorbed into cells and metabolized into carbon dioxide and water with the release of energy. 5% dextrose intravenous infusion solution allows intracellular rehydration and dextrose also serves as a carbohydrate source for cellular nutrition.

The maximum rate of glucose utilization has been estimated to be about 500- 800 mg/ kg body weight /hour.

 Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

Water for Injections

No studies for compatibility have been conducted with this product. Confirm additive compatibility before use.
Dextrose Injections are incompatible with blood for transfusion as haemolysis or clumping can occur; do not administer through the same infusion equipment as blood or blood components for transfusion (either before, during or after their administration).

Do not store above 30°C.

The container is made of Low Density-Polyethylene (LDPE) The primary packaging material
Low Density-Polyethylene (LDPE) is used for several years in the pharmaceutical industry for the primary packaging of comparable drug products.

The material is known for its compatibility with the ingredients of the drug product.
The container material, LD (Low Density)-polyethylene meets the requirements of the European Pharmacopoeia (Ph. Eur. 3.2.2).
The material shows a density of 0.9%26-0.9%30 g/cm3.The container can be sterilised at temperatures between 106-112 °C.

For single use only. Do not use unless the solution is clear and the container undamaged.
Discard any unused solution.
Aseptic techniques must be followed during the preparation of the infusion.
Any unused product or waste material should be disposed of in accordance with local
requirements.
Addition of medicinal products:
Confirm additive compatibility before use.
Clean the injection site using antiseptic solution.
Carefully introduce the sterile needle into the sterile chamber in the injection site, attach the
needle to the container with the medicinal product, introduce the needle through the second
membrane into the bag and inject the medicine. Carefully withdraw the needle.
Mix thoroughly with the solution. Use immediately.