Sodium Chloride 0.9 % w/v and Dextrose 5% w/v solution is indicated for the Treatment of sodium depletion, extracellular dehydration or hypovolaemia in cases where supply of water and carbohydrates is required due to restriction of the intake of fluids and electrolytes by normal routes.

The choice of the specific sodium chloride and Dextrose concentration, dosage, volume, rate and duration of administration depends on the age, weight, clinical condition of the patient and concomitant therapy. It should be determined by a physician. For patients with electrolyte and Dextrose abnormalities and for paediatric patients, consult a physician experienced in intravenous fluid therapy.

Rapid correction of hyponatraemia and hypernatraemia is potentially dangerous (risk of serious neurologic complications).

Adults, Older Patients And Adolescents (Age 12 Years And Over):
The recommended dosage is: 500 ml to 3 L/24h.

Administration rate:
The infusion rate is usually 40 ml/kg/24h and should not exceed the patient’s Dextrose oxidation capacities in order to avoid hyperglycaemia. Therefore the maximum acute administration rate is 5 mg/kg/min.
Paediatric Population:
The dosage varies with weight: •
0-10 kg body weight: 100 ml / kg / 24 h.
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.
Administration rate:
The administration rate varies with weight:
0-10 kg body weight: 6-8 ml/kg/h.
10-20 kg body weight: 4-6 ml/kg/h
> 20 kg body weight: 2-4 ml/kg/h.
The infusion rate should not exceed the patient’s Dextrose oxidation capacities in order to avoid hyperglycaemia. Therefore the maximum acute administration rate is 10-18 mg/kg/min depending on the total body mass.
For all patients, a gradual increase of flow rate should be considered when starting administration of Dextrose containing products.
Method of Administration:
The administration is performed by intravenous infusion.
Precautions to be taken before manipulating or administering the product:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not administer unless the solution is clear and the seal is intact. Administer immediately following the insertion of infusion set. Do not remove unit from overwrap until ready for use. The inner bag maintains the sterility of the product.
The solution should be administered with sterile equipment using an aseptic technique.
The equipment should be primed with the solution in order to prevent air entering the system.
Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed. Pressurizing intravenous solutions contained in  flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers
Additives may be introduced before or during infusion through the resealable medication port. When additive is used, verify tonicity prior to parenteral administration. Hyperosmolar solutions may cause venous irritation and phlebitis. Thus, any hyperosmolar solution is recommended to be administered through a large central vein, for rapid dilution of the hyperosmotic solution.
For further information on the product with additives, please see sections 6.2, 6.3 and 6.6.
Monitoring:
Fluid balance and the concentrations of Dextrose and electrolytes (especially sodium) in plasma must be monitored during administration. Electrolyte supplementation may be indicated according to the clinical needs of the patient.

The solution is contraindicated in patients presenting with: Known hypersensitivity to the product Extracellular hyperhydration or hypervolaemia Fluid and sodium retention Severe renal insufficiency (with oliguria/anuria) Uncompensated cardiac failure Hypernatraemia or hyperchloraemia General oedema and ascetic cirrhosis Clinically significant hyperglycaemia. The solution is also contraindicated in case of uncompensated diabetes, other known Dextrose intolerances (such as metabolic stress situations), hyperosmolar coma or hyperlactataemia.

Hypokalaemia: The infusion of Sodium chloride 0.9% w/v and Dextrose 5% w/v solution may result in hypokalaemia. Close clinical monitoring may be warranted in patients with or at risk for hypokalaemia, for example:

 Persons with metabolic alkalosis
 Persons with thyrotoxic periodic paralysis. Administration of intravenous Dextrose has been associated in aggravating hypokalaemia
 Persons with increased gastrointestinal losses (e.g., diarrhea, vomiting)
 Prolonged low potassium diet
 Persons with primary hyperaldosteronism
 Patients treated with medications that increase the risk of hypokalaemia (e.g. diuretics, beta-2 agonists or insulin)
Sodium Retention, Fluid Overload and Oedema:
Sodium chloride 0.9% w/v and Dextrose 5% w/v solution should be used with particular caution in
 Patients with metabolic acidosis
 Patients at risk of
o Hypernatraemia
o Hyperchloraemia
o Hypervolaemia
 Patients with conditions that may cause sodium retention, fluid overload and oedema (central and peripheral), such as,.
o o Primary hyperaldosteronism,
o Secondary hyperaldosteronism associated with, for example,
 hypertension,
 congestive heart failure,
 liver disease (including cirrhosis),
 renal disease (including renal artery stenosis, nephrosclerosis)
o Pre-eclampsia.
Patients taking medications that may increase the risk of sodium and fluid retention, such as corticosteroids

Hyperosmolality, Serum Electrolytes And Water Imbalance:
Depending on the volume, rate of infusion, the patient’s underlying clinical condition and capability to metabolize Dextrose, administration of Sodium chloride 0.9% w/v and Dextrose 5% w/v solution can cause:
 Hyperosmolality, osmotic diuresis and dehydration
 Electrolyte disturbances such as
o hyponatraemia (see “Sodium imbalance” below)
o hypokalaemia (see above)
o hypophosphataemia,
o hypomagnesaemia,
 Acid-base imbalance
 Overhydration/hypervolaemia and, for example, congested s tates, including central (e.g. pulmonary congestion) and peripheral oedema.
 An increase in serum Dextrose concentration is associated with an increase in serum osmolality. Osmotic diuresis associated with hyperglycaemia can result in or contribute to the development of dehydration and in electrolyte losses.
Sodium Imbalance:
Sodium chloride 0.9% w/v and Dextrose 5% w/v solution should be used with particular caution in patients with; or at risk for hyponatraemia, for example:
 children
 elderly patients
 women
 postoperatively
 persons with psychogenic polydipsia
Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, cerebral oedema, and death. Acute symptomatic hyponatraemic encephalopathy is considered a medical emergency.
Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.

Hyperglycaemia:
Rapid administration of Dextrose solutions may produce substantial hyperglycaemia and hyperosmolar syndrome. In order to avoid hyperglycaemia the infusion rate should not exceed the patient’s ability to utilize Dextrose. To reduce the risk of hyperglycaemia-associated complications, the infusion rate must be adjusted and/or insulin administered if blood Dextrose levels exceed levels considered acceptable for the individual patient.
Intravenous Dextrose should be administered with caution in patients with, for example:
Impaired glucose tolerance (such as in diabetes mellitus, renal impairment, or in the presence of sepsis, trauma, or shock),
Severe malnutrition (risk of precipitating a refeeding syndrome, see below),
Thiamine deficiency, e.g., in patients with chronic alcoholism (risk of severe lactic acidosis due to impaired oxidative metabolism of pyruvate),
Water and electrolyte disturbances that could be aggravated by increased glucose and/or free water load.
Other groups of patients in whom 5% Dextrose and 0.9% Sodium Chloride Injection solution should be used with caution include:
 Patients with ischemic stroke. Hyperglycaemia has been implicated in increasing cerebral ischemic brain damage and impairing recovery after acute ischemic strokes.
 Patients with severe traumatic brain injury (in particular during the first 24 hours following the trauma). Early hyperglycaemia has been associated with poor outcomes in patients with severe traumatic brain injury.
 Newborns (See Paediatric glycaemia-related issues).
Prolonged intravenous administration of glucose and associated hyperglycaemia may result in decreased rates of glucose-stimulated insulin secretion.
Hypersensitivity Reactions:
Hypersensitivity/infusion reactions, including anaphylaxis, have been reported (see section 4.8).
Stop the infusion immediately if signs or symptoms of hypersensitivity/infusion reactions develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Solutions containing glucose should be used with caution in patients with known allergy to corn or corn products.

Refeeding Syndrome:
Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized by the shift of potassium, phosphorus, and magnesium intracellularly as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. Careful monitoring and slowly increasing nutrient intake while avoiding overfeeding can prevent these complications.

Severe renal Impairment:
5% Dextrose and 0.9% Sodium Chloride Injection solution should be administered with particular caution to patients at risk of (severe) renal impairment. In such patients, administration may result in sodium retention and/or fluid overload.
Paediatric Use:
The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy, and should be determined by a physician experienced in paediatric intravenous fluid therapy.
Pediatric glycaemia-related issues:
Newborns, especially those born premature and with low birth weight, are at increased risk of developing hypo- or hyperglycaemia. Close monitoring during treatment with intravenous glucose solutions is needed to ensure adequate glycaemic control, in order to avoid potential long term adverse effects.
Hypoglycaemia in the newborn can cause, e.g., prolonged seizures, coma, and cerebral injury
Hyperglycaemia has been associated with cerebral injury, including intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, increased oxygen requirements, prolonged length of hospital stay, and death..
Paediatric Hyponatraemia-Related Issues:
Children (including neonates and older children) are at increased risk of developing hyponatraemia as well as for developing hyponatraemic encephalopathy.
 Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, cerebral oedema and death; therefore, acute symptomatic hyponatraemic encephalopathy is considered a medical emergency.
 Plasma electrolyte concentrations should be closely monitored in the paediatric population

Rapid correction of hyponatraemia is potentially dangerous (risk of serious neurologic complications). Dosage, rate, and duration of administration should be determined by a physician experienced in paediatric intravenous fluid therapy.

Blood:
5% Dextrose and 0.9% Sodium Chloride Injection solution should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or haemolysis.
Geriatric Use:
When selecting the volume/rate of infusion for a geriatric patient, consider that geriatric patients are generally more likely to have cardiac, renal, hepatic and other diseases or concomitant drug therapy.

 

Both the glycaemic and effects on water and electrolyte balance should be taken into account when administering 5% Dextrose and 0.9% Sodium Chloride Injection solution to patients treated with other substances that affect glycaemic control, or fluid and/or electrolyte balance.
Caution is advised in patients treated with,
 Lithium. Renal sodium and lithium clearance may be increased during administration and can result in decreased lithium levels.
 Corticosteroids, which are associated with the retention of sodium and water (with oedema and hypertension).
 Diuretics, beta-2 agonists or insulin, whom increase the risk of hypokalemia.

Fertility:
There is no information on the effects of 5% Dextrose and 0.9% Sodium Chloride Injection solution on fertility.
Pregnancy:
Intrapartum maternal intravenous glucose infusion may result in foetal hyperglycaemia and metabolic acidosis as well as rebound neonatal hypoglycaemia due to foetal insulin production.
Lactation:
5% Dextrose and 0.9% Sodium Chloride Injection solution can be used during breastfeeding.

The potential risks and benefits for each specific patient should be carefully considered before administration.

There is no information on the effects of 5% Dextrose and 0.9% Sodium Chloride Injection solution on the ability to operate an automobile or other heavy machinery.

The following adverse reactions have been reported in post-marketing experience, listed by MedDRA System Organ Class (SOC), then where feasible, by Preferred Term in order of severity.
Frequencies cannot be estimated from the available data, as all listed adverse reactions are based on spontaneous reporting.

Note: Potential manifestation in patients with allergy to corn, see section 4.4
Other adverse reactions reported with isotonic saline and glucose infusions include:
Hyponatraemia, which may be symptomatic
Hyperchloraemic acidosis
Adverse reactions may be associated to the medicinal product(s) added to the solution; the nature of the additive will determine the likelihood of any other adverse reactions.

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 to SFDA.
Note: To report any side effects please contact;
National Pharmacovigilance and Drug Safety 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

 

Excess administration of 5% Dextrose and 0.9% Sodium Chloride Injection solution can cause:
Hyperglycaemia, adverse effects on water and electrolyte balance and corresponding complications. For example, severe hyperglycaemia and severe dilutional hyponatraemia and their complications, can be fatal.
Hyponatraemia (which can lead to CNS manifestations, including seizures, coma, cerebral edema and death).
Hypernatraemia especially in patients with severe renal impairment.
Fluid overload (which can lead to central and/or peripheral edema).
See also sections 4.4 and 4.8.
A clinically significant overdose of 5% Dextrose and 0.9% Sodium Chloride Injection solution may, therefore, constitute a medical emergency.
When assessing an overdose, any additives in the solution must also be considered..
Interventions include discontinuation of 5% Dextrose and 0.9% Sodium Chloride Injection solution administration, dose reduction, administration of insulin and other measures as indicated for the specific clinical constellation

 

Pharmacotherapeutic group “Electrolytes with Carbohydrates”, ATC code: “B05BB02.

The pharmacokinetic properties of this solution are those of its components (glucose, sodium and chloride).
After injection of radiosodium (24Na), the half-life is 11 to 13 days for 99% of the injected Na and one year for the remaining 1%. The distribution varies according to tissues: it is fast in muscles, liver, kidney, cartilage and skin; it is slow in erythrocytes and neurons; it is very slow in the bone. Sodium is predominantly excreted by the kidneys, but (as described earlier).
There is extensive renal reabsorption. Small amounts of sodium are lost in the faeces and sweat. The two main metabolic pathways of glucose are gluconeogenesis (energy storage) and glycogenolysis (energy release). Glucose metabolism is regulated by insulin.

Preclinical safety data of this solution for infusion in animals are not relevant since its constituents are physiological components of animal and human plasma. 
Toxic effects are not to be expected under the condition of clinical application. The safety of potential additives should be considered separately.

 

Water for Injections

Incompatibility of the medicinal product to be added with the solution in container must be assessed before addition. In the absence of compatibility studies, this solution must not be mixed with other medicinal products.
The Instructions for Use of the medicinal product to be added must be consulted. Before adding a drug, verify it is soluble and stable in water at the pH of 5% Dextrose and 0.9% Sodium Chloride Injection (see section 3).
As guidance, the following medications are incompatible with the 5% Dextrose and 0.9% Sodium Chloride Injection (non-exhaustive listing):
Ampicillin sodium
Mitomycin
Amphotericin B
Those additives known to be incompatible should not be used.
Because of the presence of glucose, 5% Dextrose and 0.9% Sodium Chloride Injection should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or haemolysis.

3 years.

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.
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.