Parenteral Nutrition and Hydration
This Medicinal Product is indicated for the treatment of carbohydrate and fluid depletion.
This Medicinal Product is also used as a vehicle and diluent for compatible medicinal
products for parenteral administration.

Posology
Adults, the Elderly and Children:
The concentration and dosage of glucose solution for intravenous use is determined by
several factors including the age, weight and clinical condition of the patient. Serumglucose
concentrations may need to be carefully monitored.
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:
- 10-20 kg body weight:
- > 20 kg body weight:
100 ml/kg/24h.
1000 ml + 50 ml /kg over 10 kg / 24h.
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 this product 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.
This product is a isosmotic 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.

 Simultaneous administration of dextrose solutions (without electrolytes) with blood through the same infusion set; risk of RBC cell pseudoagglutination. Hypertonic Dextrose Solutions  Hypersensitivity to corn products.  Anuria.  Hepatic or diabetic coma.  Intracranial or intraspinal hemorrhage.  Dehydrated patients with delirium tremens. The solution is contraindicated in case of uncompensated diabetes, other known glucose intolerances (such as metabolic stress situations), hyperosmolar coma, hyperglycaemia, hyperlactatemia. Glucose solution should not be used after acute ischemic strokes as hyperglycemia has been implicated in increasing cerebral ischemic brain damage and impairing recovery.  Infusion of glucose solution is contraindicated in the first 24 hours following head trauma, and blood glucose concentration should be closely monitored during intracranial hypertension episodes.

Warnings
Administer concentrated dextrose injections under supervision of a qualified clinician
familiar with IV technique and possible complications.
Use with caution in patients with known subclinical or overt diabetes mellitus.
Use with caution in infants of diabetic mothers except when indicated in hypoglycemic
neonates.
Hyperglycemia and Hyperosmolar Syndrome
Risk of hyperglycemia and/or hyperosmolar syndrome (e.g., dehydration, hypovolemia,
mental confusion, loss of consciousness) with rapid administration, especially in patients
with chronic uremia and known carbohydrate intolerance. Administer hypertonic dextrose
solutions slowly. Monitor blood and urine glucose levels; administration of insulin may be
required.
When infusions of concentrated dextrose are discontinued, consider a 5 or 10% dextrose
substitute solution to prevent rebound hypoglycemia.

Fluid and/or Solute Overload
Possible fluid and/or solute overload resulting in dilution of serum electrolytes,
overhydration, congested conditions, or pulmonary edema.
Risk of dilutional conditions is inversely proportional to the electrolyte concentration
administered. Risk of solute overload and resultant congestive conditions with peripheral
and/or pulmonary edema is directly proportional to the electrolyte concentration
administered.

Infusion Site Reactions
Infusion site and other reactions (e.g., fever, infection at the injection site, venous
thrombosis, hypervolemia, extravasation, phlebitis extending from injection site) possible.
May occur because of the solution (e.g., contamination) or administration technique.
Hypertonic dextrose injections may cause local pain or venous irritation or damage. (See
IV Administration under Dosage and Administration.) If adverse effects occur, discontinue

infusion; evaluate patient and institute appropriate therapeutic measures; save remainder of
fluid for examination, if necessary.

 

When dextrose is used in fixed combination with sodium chloride, consider the cautions,
precautions, and contraindications associated with sodium chloride.
Electrolyte disturbances (i.e., hypokalemia) produced by large doses of dextrose may
predispose digitalized patients to toxicity. So additional potassium may be required in
fasting patients with normal renal function.
Consider the use of other drugs (e.g., glucagon, corticosteroids, and epinephrine) as they
affect the blood glucose level.

Fertility
Not relevant.
Pregnancy
Category C.
Lactation
Not known whether dextrose is excreted into milk. Use with caution in nursing women.

Not relevant.

Hypovolemia, hypervolemia, dehydration, oedema, fever, mental confusion,
unconsciousness, hyperosmolar syndrome, hyperglycaemia, hypokalaemia, acidosis,
hypophosphataemia, hypomagnesemia, polyuria, glycosuria, ketonuria, nausea, diarrhoea,
polydipsia, vein irritation, tissue necrosis, pulmonary oedema, tachypnoea
Reactions which may occur because of the solution or the technique of administration
include febrile response, infection at the site of injection, venous thrombosis or phlebitis
extending from the site of injection.
The physician should also be alert to the possibility of adverse reactions to drug additives.
Prescribing information for drug additives to be administered in this manner should be
consulted.

If the patient is over 65 years of age or very young he may has an increased chance of
getting side effects.
To report any side effect(s):
Saudi Arabia:
The 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
Other GCC States:
Please contact the relevant competent authority.

 Risk of hyperglycemia and/or hyperosmolar syndrome (e.g., dehydration,
hypovolemia, mental confusion, loss of consciousness).
 Possible fluid and/or solute overload resulting in dilution of serum electrolytes,
overhydration, congested conditions, or pulmonary edema.
 Risk of solute overload and resultant congestive conditions with peripheral and/or
pulmonary edema is directly proportional to the electrolyte concentration
administered.
 See undesirable effects section.
Emergency measures
In the event of a fluid or solute overload during parenteral therapy, revaluate the patient's
condition and initiate appropriate corrective treatment.
Monitor blood and urine glucose levels; administration of insulin may be required.

 Increases blood glucose concentrations and provides calories and water.
 May aid in minimizing liver glycogen depletion, exert a protein-sparing action, and
decrease or prevent ketosis.
 Induces diuresis.
Pharmacotherapeutic group Code:
ATC code: B05BA03

Readily metabolized to carbon dioxide and water.

Not relevant

Water for injection

Knowledge of added drug compatibility is needed before mixing drugs.
If drugs mixed together, the mixture should be inspected for precipitations, turbidity or
change in colour, however not all incompatibilities are visible.

2 years for Plastic bag NPVC. 5 years for Plastic bottle. 5 years for glass bottle. From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Store below 30°C for:
Plastic bottle 500 ml and 1000 ml
Non-PVC Bag: 250 ml, 500 ml and 1000 ml
Store below 25°C for:
Plastic bottle size: 250 ml.
Non-PVC Bags size: 50 ml, 100 ml and 150 ml
Glass bottle size: 500 ml

50 ml, 100 ml, 150 ml, 250ml, 500ml and 1000ml Non-PVC Bags.
500 ml 250ml and 1000 ml Plastic bottle (polyethylene).
500 ml glass bottle.

Before administration, the product should be visually inspected for any particulate
matter and discoloration. For single use only. Any unused solution should be
discarded.