This solution is indicated for use in adults and pediatric patients as a source of electrolytes,
calories and water for hydration

This solution is for intravenous use only.
Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition
of the patient and laboratory determinations. Frequent laboratory determinations and clinical
evaluation are essential to monitor changes in blood glucose and electrolyte concentrations,
and fluid and electrolyte balance during prolonged parenteral therapy.
When a hypertonic solution is to be administered peripherally, it should be slowly infused
through a small bore needle, placed well within the lumen of a large vein to minimize venous
irritation. Carefully avoid infiltration.
Fluid administration should be based on calculated maintenance or replacement fluid
requirements for each patient.
The presence of calcium ions in this solution should be considered when phosphate is present
in additive solutions, in order to avoid precipitation.
Some additives may be incompatible. Consult with pharmacist. When introducing additives,
use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be
inspected visually for particulate matter and discoloration prior to administration, whenever
solution and container permit.

Solutions containing lactate are not for use in the treatment of lactic acidosis. Solutions containing lactate should be used with great care in patients with metabolic or respiratory alkalosis, and in those conditions in which there is an increased level or an impaired utilization of lactate, such as severe hepatic insufficiency.
The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.
Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema.
Solutions containing potassium ions should be used with great care, if at all, in patients with
hyperkalemia, severe renal failure, and in conditions in which potassium ions retention is present.
In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.
Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation.
PRECAUTIONS
General
This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.
Extraordinary electrolytes losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.
Additional essential electrolytes, minerals and vitamins should be supplied as needed.
Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients.
Care should be exercised in administering solutions containing sodium or potassium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.
Solutions containing calcium should be used with caution in the presence of cardiac disease,
particularly when accompanied by renal disease. Parenteral calcium should be administered with extreme caution to patients receiving digitalis preparations.
Solutions containing lactate should be used with caution. Excess administration may result in
metabolic alkalosis.The conversion of lactate to bicarbonate is markedly delayed in the presence of tissue anoxia and reduced capacity of the liver to metabolize lactate. This may occur under conditions such as metabolic
acidosis associated with circulatory insufficiency, extracorporeal circulation, hypothermia, glycogen storage disease, liver dysfunction, respiratory alkalosis, shock or cardiac decompensation.
Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.
To minimize the risk of possible incompatibilities arising from mixing this solution with other
additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.
Do not use plastic container in series connection.
If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.
This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.
Use only if solution is clear and container and seals are intact.
Laboratory Tests
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in this or an alternative solution.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with 5% Dextrose in Lactated Ringer’s Injection have not been performed to evaluate
carcinogenic potential, mutagenic potential or effects on fertility.
Pregnancy: Teratogenic Effects
Pregnancy Category C. Animal reproduction studies have not been conducted with 5% Dextrose in Lactated Ringer’s Injection. It is also not known whether 5% Dextrose in Lactated Ringer’s Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Dextrose in Lactated Ringer’s Injection should be given to a pregnant woman only if clearly needed.
Labor and Delivery
The effects of 5% Dextrose in Lactated Ringer’s Injection on the duration of labor or delivery, on the possibility that forceps delivery or other intervention or resuscitation of the newborn will be necessary, and on the later growth, development, and functional maturation of the child are unknown.”
As reported in the literature, 5% Dextrose in Lactated Ringer’s Injection has been administered during labor and delivery. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.

Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 5% Dextrose in Lactated Ringer’s Injection is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of 5% Dextrose in Lactated Ringer’s Injection in pediatric patients has not been established by adequate and well-controlled studies. However, the use of potassium chloride in pediatric patients to treat potassium deficiency states when oral replacement therapy is not feasible is referenced in the medical literature.
For patients receiving potassium supplement at greater than maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended.
Dextrose is safe and effective for the stated indications in pediatric patients (see Indications and Usage). As reported in the literature, the dosage selection and constant infusion rate of intravenous
dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.
In neonates or in very small infants even small volumes of fluid may affect fluid and electrolyte
balance. Care must be exercised in treatment of neonates, especially pre-term neonates, whose renal function may be immature and whose ability to excrete fluid and solute loads may be limited. Fluid intake, urine output, and serum glucose and electrolytes should be monitored closely.
See WARNINGS and DOSAGE AND ADMINISTRATION.
Geriatric Use
Clinical studies of 5% Dextrose in Lactated Ringer’s Injection, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. See WARNINGS.

– see Contraindications

Pregnancy Category C. Animal reproduction studies have not been conducted with 5% Dextrose in Lactated Ringer’s Injection. It is also not known whether 5% Dextrose in Lactated Ringer’s Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Dextrose in Lactated Ringer’s Injection should be given to a pregnant woman only if clearly needed.

There is no information of the effects of Dextrose 5% & Lactated Ringer’s on the ability to operate an automobile or other heavy machinery.

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, extravasation and hypervolemia.
Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.
Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.
If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an
acidifying effect.
Although the metabolism of lactate to bicarbonate is a relatively slow process, aggressive
administration of sodium lactate may result in metabolic alkalosis. Careful monitoring of blood acidbase balance is essential during the administration of sodium lactate.
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 an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

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

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition and institute appropriate corrective treatment.

5% Dextrose in Lactated Ringer’s Injection provides electrolytes and calories, and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient. This solution also contains lactate which produces a metabolic alkalinizing effect.
Sodium, the major cation of the extracellular fluid, functions primarily in the control of water
distribution, fluid balance and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.
Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.
Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.
Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate. In the ionized form, calcium is essential for the functional
mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular
irritability.Sodium lactate is a racemic salt containing both the levo form, which is oxidized by the liver to bicarbonate, and the dextro form, which is converted to glycogen. Lactate is slowly metabolized to carbon dioxide and water, accepting one hydrogen ion and resulting in the formation of bicarbonate for the lactate consumed. These reactions depend on oxidative cellular activity.
Dextrose provides a source of calories. Dextrose is readily metabolized, may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.

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Water for Injections

see Contraindications

Do not store above 30ºC.

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).

Solution containing visible solid particles should not be used.
Do not use unless the solution is clear and the container undamaged.
Do not connect in series and purge the infusion system to remove all air because of the risk of air embolism.
Discard any unused solution.
Verify the integrity of the container and the site for attachment.
For slow infusion only.
Addition of Medicinal Products:
The healthcare professional should assess compatibility by checking absence of colour change or formation of precipitate, insoluble complexes or crystals. Mix thoroughly with the solution. Use immediately after addition of medicine