5% Dextrose w/v with Compound Sodium Lactate (Ringer Lactate & Dextrose
5% w/v solution) is used in the following indications when a source of
carbohydrate is required: - Restoration of extracellular fluid and electrolyte balance
or replacement of extracellular fluid loss where isotonic concentrations of
electrolytes are sufficient
- Short term volume replacement (alone or in association with colloid) in case of
hypovolemia or hypotension. - Regulation or maintenance of metabolic acidosis
balance and/or treatment of mild to moderate metabolic acidosis (except lactic
acidosis)

Posology
Adults and the Elderly
Dosage, rate, and duration of administration are to be individualized and depend
upon the indication for use, the patient’s age, weight, clinical condition, and
concomitant treatment, and on the patient’s clinical and laboratory response to
treatment. It should be determined by a physician experienced in intravenous fluid
therapy.
Recommended dosage: The amount of 5% Dextrose w/v solution with Compound
Sodium Lactate needed to restore normal blood volume is 3 to 5 times the volume
of lost blood.
The recommended dosage is:
• for adults: 500 ml to 3Liters /24h
• for infants, toddlers and children :
• 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 infusion rate is usually 40 mL/kg/24h in adults.
Paediatric patients The safety and efficacy of 5% Dextrose w/v solution with
Compound Sodium Lactate in children has not been established by adequate and
well-controlled trials; however, the use of electrolyte solutions in the paediatric
population is referenced in the medical literature.
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 pediatric intravenous fluid therapy
Lactate-containing solutions should be administered with particular caution to
neonates and infants less than 6 months of age.

Pediatric infusion rate is 5 ml/kg/h in average but the value varies with age: •
infants: 6-8 mL/kg/h • toddlers: , 4-6 mL/kg/h,
• Children: 2-4 mL/kg/h.

In children with burns, the dose is on average 3.4 mL/kg/per cent burn at 24 h postburn
and 6.3 mL/kg/per cent burn at 48 h. In severely head-injured children the
dose is on average 2850 mL/m².
Infusion rate and total volume can be higher in surgery or in case of need.
The infusion rate of intravenous solutions containing Dextrose should be selected
with caution in children. It should not exceed the patient’s ability to utilize
Dextrose in order to avoid hyperglycaemia. Therefore the maximum acute
administration rate 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. See also section
4.4, Paediatric population.
Note: - infants and toddlers: aged from 28 days to 23 months (a toddler is an infant
who can walk)
- Children: age from about 2 to 11 years
Use in geriatric patients
When selecting the type of infusion solution and 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.
Method of administration:

The solution is for intravenous administration through a sterile and non-pyrogenic
administration set using aseptic technique. The equipment should be primed with
the solution in order to prevent air entering the system.
The solution should be inspected visually for particulate matter and discoloration
prior to administration. Do not administer unless the solution is clear, free from
visible particles and the seal is intact. Do not remove unit from overwrap until
ready for use. The inner bag maintains the sterility of the solution. Administer
immediately following the insertion of infusion set.
Do not connect flexible plastic containers in series in order to avoid air embolism
due to possible residual air contained in the primary container. 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.
This hypertonic solution should be administered via a large peripheral or
preferably a central vein. Rapid infusion in peripheral veins may be harmful.
Additives may be introduced before infusion or during infusion through the
injection site. When making additions to 5% Dextrose w/v solution with
Compound Sodium Lactate, aseptic technique must be used. Mix the solution
thoroughly when additives have been introduced. Do not store solutions containing
additives.
For information on incompatibilities and preparation of the product with additives,
please see sections 6.2 and 6.6.

As for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and 5% Dextrose w/v solution with Compound Sodium Lactate is contraindicated in newborns (≤ 28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream). For patients over 28 days of age please see section 4.4. 5% Dextrose w/v solution with Compound Sodium Lactate is also contraindicated in patients with • A known hypersensitivity to sodium lactate. • Extracellular hyperhydration or hypervolemia • Severe renal insufficiency (with oliguria/anuria) • Uncompensated cardiac failure • Hyperkalemia • Hypercalcaemia • Metabolic alkalosis • Ascitic cirrhosis • Severe metabolic acidosis • Conditions associated with increased lactate levels (hyperlactatemia) including lactic acidosis, or impaired lactate utilization, such as severe hepatic insufficiency. • Concomitant digitalis therapy (see section 4.5 Interactions with other medicinal products and other forms of interaction) The solution is also contraindicated in case of uncompensated diabetes, other. known Dextrose intolerances (such as metabolic stress situations), hyperosmolar. coma, hyperglycemia, hyperlactatemia

Hypersensitivity reactions
The infusion must be stopped immediately if any signs or symptoms of a suspected
hypersensitivity reaction develop. Appropriate therapeutic countermeasures must
be instituted as clinically indicated. Solutions containing Dextrose should be used
with caution in patients with known allergy to corn or corn products.
Incompatibilities
Ceftriaxone In patients older than 28 days (including adults), ceftriaxone must not
be administered simultaneously with intravenous calcium-containing solutions,
including Compound Sodium Lactate & Dextrose 5% solution, through the same
infusion line. If the same infusion line is used for sequential administration, the
line must be thoroughly flushed between infusions with a compatible fluid. . For
patients under 28 days, please see section 4.3.
Administration of citrate anticoagulated/preserved blood Due to the risk of
coagulation precipitated by its calcium content, 5% Dextrose w/v solution with
Compound Sodium Lactate must not be added to or administered simultaneously
through the same tubing with citrate anticoagulated/preserved blood.
Due to Dextrose presence, 5% Dextrose w/v solution with Compound Sodium
Lactate should not be infused concomitantly to massive blood transfusion (risk of
pseudo-agglutination) through the same infusion set.
Electrolyte balance
Hypernatraemia Compound Sodium Lactate solution should only be administered
to patients with hypernatraemia after careful consideration of the underlying cause
and alternative intravenous fluids. Monitoring of plasma sodium and volume status
during treatment is recommended. Compound Sodium Lactate solution should be

administered with particular caution in patients with conditions predisposing to
hypernatraemia (such as adrenocortical insufficiency, diabetes insipidus or
extensive tissue injury) and in patients with cardiac disease.”
Hyperchloraemia Compound Sodium Lactate solution should only be administered
to patients with hyperchloraemia after careful consideration of the underlying
cause and alternative intravenous fluids. Monitoring of plasma chloride and acidbase
balance during treatment is recommended. Compound Sodium Lactate
solution should be administered with particular caution to patients with conditions
predisposing to hyperchloraemia (such as renal failure and renal tubular acidosis,
diabetes insipidus), and patients with urinary diversion or patients taking certain
diuretics (carbonic anhydrase inhibitors e.g. acetazolamide) or steroids (androgens,
estrogens corticosteroids) and in patients with severe dehydration
Use in patients with potassium deficiency
Although 5% Dextrose w/v solution with Compound Sodium Lactate has a
potassium concentration similar to the concentration in plasma, it is insufficient to
produce a useful effect in case of severe potassium insufficiency and therefore it
should not be used for this purpose.
Use in patients at risk for hyperkalaemia
5% Dextrose w/v solution with Compound Sodium Lactate should be administered
with particular caution to patients with conditions predisposing to hyperkalaemia
(such as severe renal impairment or adrenocortical insufficiency, acute
dehydration, or extensive tissue injury or burns) and in patients with cardiac
disease.
The plasma potassium level of the patient must be particularly closely monitored in
patients at risk of hyperkalaemia.
Use in patients at risk for hypercalcaemia
Calcium chloride is irritant, therefore care should be taken to prevent extravasation
during intravenous injection and intramuscular injection must be avoid

Solutions containing calcium salts should be used with caution in patients with
conditions predisposing to hypercalcaemia, such as patients with renal impairment
and granulomatous diseases associated with increased calcitriol synthesis such as
sarcoidosis, calcium renal calculi or a history of such calculi fluid balance/renal
function.
Use in patients with renal impairment
5% Dextrose w/v solution with Compound Sodium Lactate should be administered
with particular caution to patients with renal impairment. In such patients
administration of 5% Dextrose w/v solution with Compound Sodium Lactate may
result in sodium and/or potassium retention.
Risk of Fluid and/or Solute Overload and Electrolyte Disturbances
Depending on the volume and rate of infusion, intravenous administration of 5%
Dextrose w/v solution with Compound Sodium Lactate can cause
• Fluid and/or solute overload resulting in overhydration and, for example,
congested states,including pulmonary congestion and edema.
• Clinically relevant electrolyte disturbances and acid-base imbalance.
Clinical evaluation and periodic laboratory determinations may be necessary to
monitor changes in fluid balance, electrolyte and Dextrose concentrations and acidbase
balance during prolonged parenteral therapy or whenever the condition of the
patient or the rate of administration warrants such evaluation.
High volume infusion must be used under specific monitoring in patients with
cardiac or pulmonary failure.
Use in patients with hypervolemia, overhydration or conditions causing sodium
retention and edema 5% Dextrose w/v solution with Compound Sodium Lactate
should be administered with particular caution to hypervolemic or overhydrated
patients.
Due to the sodium chloride content 5% Dextrose w/v solution with Compound
Sodium Lactate should be administered with particular caution to patients with
conditions that may cause sodium retention, fluid overload and edema, such as
patients with primary hyperaldosteronism, secondary hyperaldosteronism
(associated with, e.g., hypertension, congestive heart failure, renal artery stenosis
or nephrosclerosis), or preeclampsia. (see also Section Error! Reference source not
found.)
Acid-base balance Use in patients at risk for alkalosis 5% Dextrose w/v solution
with Compound Sodium Lactate should be administered with particular caution to
patients at risk for alkalosis. Because lactate is metabolized to bicarbonate

administration may result in, or worsen, metabolic alkalosis. Seizure may be
precipitated by the alkalosis induced by lactate but this is uncommon.
Dextrose metabolism Use in patients with or at risk for hyperglycemia Solutions
containing Dextrose should be used with caution in patients with impaired
Dextrose tolerance or diabetes mellitus. For newborns – especially those born
premature and with low birth weight, please see below “use in paediatric patients”.
Lactate is a substrate for gluconeogenesis. Therefore, Dextrose levels should be
carefully monitored in Type 2 diabetics receiving 5% Dextrose w/v solution with
Compound Sodium Lactate
Because 5% Dextrose w/v solution with Compound Sodium Lactate contains
Dextrose and lactate (which is metabolized to Dextrose ), administration of 5%
Dextrose w/v solution with Compound Sodium Lactate that exceeds the metabolic
capacity for Dextrose may lead to hyperglycaemia.
Hyperglycaemia has been implicated in increasing cerebral ischemic brain damage
and impairing recovery after acute ischemic strokes. Caution is recommended in
using Dextrose containing solutions in such patients.
Early hyperglycaemia has been associated with poor outcomes in patients with
severe traumatic brain injury. Infusion of Dextrose solution could be
contraindicated in the first 24 hours following head trauma and blood Dextrose
concentration should be closely monitored during intracranial hypertension
episodes.
If hyperglycaemia occurs, the rate of administration should be reduced and/or
insulin administered, or the insulin dose adjusted
Use in paediatric patients
Newborns – especially those born premature and with low birth weight - are at
increased risk of developing hypo- or hyperglycaemia and therefore need close
monitoring during treatment with intravenous Dextrose solutions to ensure
adequate glycaemic control in order to avoid potential long term adverse effects. •

Hypoglycaemia in the newborn can cause prolonged seizures, coma and brain
damage. • Hyperglycaemia has been associated with intraventricular haemorrhage,
late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing
enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and
death.
In order to avoid potentially fatal over infusion of intravenous fluids to the
neonate, special attention needs to be paid to the method of administration. When
using a syringe pump to administer intravenous fluids or medicines to neonates, a
bag of fluid should not be left connected to the syringe. When using an infusion
pump all clamps on the intravenous administration set must be closed before
removing the administration set from the pump, or switching the pump off. This is
required regardless of whether the administration set has an anti-free flow device.
The intravenous infusion device and administration equipment must be frequently
monitored.
Plasma electrolyte concentrations should be closely monitored in the paediatric
population as this population may have impaired ability to regulate fluids and
electrolytes.
Other warnings Osmolarity 5% Dextrose w/v solution with Compound Sodium
Lactate is a hypertonic solution, with an approximate osmolarity of 555 mOsm/l.
The normal physiologic serum osmolarity range is approximately 280 to 310
mOsmol/L.

Administration of substantially hypertonic solutions may cause venous irritation,
including phlebitis. Hyperosmolar solutions should be administered with caution, if
at all, to patients with hyperosmolar states.
Administration
Adding other medication or using an incorrect administration technique might
cause the appearance of fever reactions due to the possible introduction of
pyrogens. In such case the infusion must be stopped immediately.
For information on incompatibilities and preparation of the product with additives,
please see sections 6.2 and 6.6.
 

Ceftriaxone: See section 4.3 and 4.4 for more information.
Interaction related to the presence of sodium: Caution is advised when
administering 5% Dextrose w/v solution with Compound Sodium Lactate to
patients treated with drugs that may increase the risk of sodium and fluid retention
(with oedema and hypertension), such as corticosteroids.
Interaction related to the presence of potassium: Because of its potassium content,
5% Dextrose w/v solution with Compound Sodium Lactate should be administered
with caution in patients treated with agents or products that can cause
hyperkalaemia or increase the risk of hyperkalaemia, such as - Potassium-sparing
diuretics (amiloride, spironolactone, triamterene, alone or in association). -
Angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor
antagonists - Tacrolimus, cyclosporin.
Administration of potassium in patients treated with such medications can produce
severe and potentially fatal hyperkalaemia, particularly in patients with severe
renal insufficiency.
Interaction related to the presence of calcium: Administration of calcium may
increase the effects of digitalis and lead to serious or fatal cardiac arrhythmia.
Therefore, larger volumes or a faster infusion rates should be used with caution in
patients treated with digitalis glycosides.

- Caution is advised when administering 5% Dextrose w/v solution with
Compound Sodium Lactate to patients treated with thiazide diuretics or vitamin D,
as these can increase the risk of hypercalcemia. - Bisphosphonates, fluoride, some
fluoroquinolones and tetracyclines which are less absorbed (lower availability)
when administered with calcium.
Interaction related to the presence of lactate (which is metabolized into
bicarbonate):
Caution is advised when administering 5% Dextrose w/v solution with Compound
Sodium Lactate to patients treated with drugs for which renal elimination is pH
dependent. Due to the alkalinizing action of lactate (formation of bicarbonate), 5%
Dextrose w/v solution with Compound Sodium Lactate may interfere with the
elimination of such drugs. - Renal clearance of acidic drugs such as salicylates,
barbiturates, and lithium may be increased because of the alkalinisation of urine by
the bicarbonate resulting from lactate metabolism. - Renal clearance of alkaline
drugs, such as sympathomimetics (e.g. ephedrine, pseudoephedrine) and stimulants
(e.g. dexamphetamine sulfate, phenfluramine hydrochloride) may be decreased

Pregnancy 5% Dextrose w/v solution with Compound Sodium Lactate can be used
safely during pregnancy and lactation as long as the electrolyte- and fluid balance
is controlled
Breast-feeding It is reminded that calcium crosses the placenta and is distributed
into breast milk.
Additions When a medication is added, the nature of the drug and its use during
pregnancy and lactation have to be considered separately.

No studies have been conducted on the influence of 5% Dextrose w/v solution with
Compound Sodium Lactate on the ability to operate an automobile or other heavy
machinery.

The following adverse reactions (listed by MedDRA System Organ Class) have
been reported spontaneously during the post-market experience. The frequency
cannot be estimated from the available data.

System Organ Class (SOC)	Adverse reactions (Preferred Term)	Frequency category
Immune System Disorders	Hypersensitivity/infusion reactions, including Anaphylactic/Anaphylactoid reactions, possibly manifested by one or more of the following symptoms: Angioedema, Chest pain, Chest discomfort, Bronchospasm, Dyspnea, Cough, Urticaria, Rash, Pruritus, Erythema, Nausea, Pyrexia,	Not known
General Disorders and Administration Site Conditions	Infusion site reactions possibly manifested by one or more of the following symptoms: Infusion site pruritus, Infusion site erythema, Infusion site anaesthesia(numbness)	Not known

The following adverse reactions have been reported spontaneously during the use
of other sodium-lactate containing solutions
• Other manifestations of hypersensitivity/infusion reactions: Laryngeal edema
(Quincke’s edema), Bradycardia, Tachycardia, Blood pressure decreased,
Respiratory distress, Flushing, Throat irritation, Skin swelling, Paraesthesia,
Hypoesthesia oral, Dysgeusia, Anxiety, Headache, Nasal congestion, Sneezing
• Electrolyte disturbances
• Hyperkalaemia
• Hypervolemia
• Panic Attack
Other infusion site reaction symptoms: Infection at the site of injection, Phlebitis,
Extravasation, Infusion site inflammation, Infusion site swelling, Infusion site rash,
Infusion site pain, Infusion site burning
Reporting of suspected adverse reactions Reporting suspected adverse reactions
after authorisation of the medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal product.
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.

An excessive volume or too high a rate of administration of 5% Dextrose w/v
solution with Compound Sodium Lactate may lead to fluid and sodium overload
with a risk of edema (peripheral and/or pulmonary), particularly when renal
sodium excretion is impaired. In this case extra renal dialysis may be necessary.
Excessive administration of potassium may lead to the development of
hyperkalemia, especially in patients with renal impairment. Symptoms include
paresthesia of the extremities, muscle weakness, paralysis, cardiac arrhythmias,
heart block, cardiac arrest, and mental confusion.
Excessive administration of calcium salts may lead to hypercalcemia. Symptoms of
hypercalcemia may include anorexia, nausea, vomiting, constipation, abdominal
pain, muscle weakness, mental disturbances, polydipsia, polyuria,
nephrocalcinosis, renal calculi, and, in severe cases, cardiac arrhythmias and coma.
Too rapid intravenous injection of calcium salts may also lead to many of the
symptoms of hypercalcemia as well as to chalky taste, hot flushes, and peripheral
vasodilatation. Mild asymptomatic hypercalcemia will usually resolve on stopping
administration of calcium and other contributory drugs such as vitamin D. If
hypercalcemia is severe, urgent treatment (such as loop diuretics, hemodialysis,
calcitonin, bisphosphonates, trisodium edetate) is required.
Excessive administration of lactate may lead to metabolic alkalosis. Metabolic
alkalosis may be accompanied by hypokalemia. Symptoms may include mood

changes, tiredness, shortness of breath, muscle weakness, and irregular heartbeat.
Muscle hypertonicity, twitching, and tetany may develop especially in
hypocalcemic patients. Treatment of metabolic alkalosis due to bicarbonate
overdose consists mainly of appropriate correction of fluid and electrolyte balance.
Replacement of calcium, chloride, and potassium may be of particular importance.
Excessive administration of a Dextrose -containing solution may lead to
hyperglycemia, hyperosmolarity, osmotic diuresis, and dehydration.
When overdose is related to medications added to the solution infused, the signs
and symptoms of over infusion will be related to the nature of the additive being
used. In the event of accidental over infusion, treatment should be discontinued
and the patient should be observed for the appropriate signs and symptoms related
to the drug administered. The relevant symptomatic and supportive measures
should be provided as necessary

Pharmacotherapeutic group (ATC code): B05BB02 “Electrolytes with
Carbohydrates”.
5% Dextrose w/v solution with Compound Sodium Lactate (Ringer Lactate &
Dextrose 5% w/v solution) is an hypertonic solution of electrolytes and Dextrose .
The pharmacological properties of the 5% Dextrose w/v solution with Compound
Sodium Lactate (Ringer Lactate & Dextrose 5% w/v solution) are those of its
components (Dextrose, sodium, potassium, calcium, chloride and lactate).
Dextrose is the main source of energy, and this solution provides 200 kcal/L.
The main effect of 5% Dextrose w/v solution with Compound Sodium Lactate
(Ringer Lactate & Dextrose 5% w/v) is the expansion of the extracellular
compartment including both the interstitial fluid and the intravascular fluid.
The lactate is metabolised into bicarbonate, mainly in the liver, and produces an
alkalinising effect on the plasma.
In healthy volunteers receiving Compound Sodium Lactate (Ringer Lactate),
central venous pressure changes were associated with a secretion of atrial
natriuretic peptide.
There is no significant changes in glucagon, norepinephrine, epinephrine, blood
Dextrose and insulin levels in aortic surgery patients receiving Compound Sodium
Lactate & Dextrose 5% w/v (Ringer Lactate & Dextrose 5% w/v).
When medication is added to 5% Dextrose w/v solution with Compound Sodium
Lactate (Ringer Lactate & Dextrose 5% w/v), the overall pharmacodynamics of the
solution will depend on the nature of the drug used.

The pharmacokinetic properties of the 5% Dextrose w/v solution with Compound
Sodium Lactate (Ringer Lactate & Dextrose 5% w/v solution) are those of its
components (Dextrose, sodium, potassium, calcium, chloride and lactate).
Infusion of 5% Dextrose w/v solution with Compound Sodium Lactate (Ringer
Lactate & Dextrose 5% w/v) in normal hemodynamically stable adults does not
increase circulating lactate concentrations.
The pharmacokinetics of D-lactate and L-lactate are similar.

The lactate in Compound Sodium Lactate & Dextrose 5% w/v solution (Ringer
Lactate & Dextrose 5% w/v solution) is metabolized by both oxidation and
gluconeogenesis, predominantly in the liver, and bicarbonate is generated by both
processes over 1-2 h.
When medication is added to 5% Dextrose w/v solution with Compound Sodium
Lactate (Ringer Lactate & Dextrose 5% w/v), the overall pharmacokinetics of the
solution will depend on the nature of the drug used.

Preclinical safety data of 5% Dextrose w/v solution with Compound Sodium
Lactate (Ringer Lactate & Dextrose 5% w/v) solution in animals are not relevant
since its constituents are physiological components in 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

Ceftriaxone must not be mixed with calcium-containing solutions including 5%
Dextrose w/v solution with Compound Sodium Lactate. See also sections 4.3 and
4.4.
As with all parenteral solutions additives may be incompatible. Compatibility of
the additives with the Compound Sodium Lactate & Dextrose 5% solution and
Viaflo container must be assessed before addition. After addition of an additive,
check for a possible colour change and/or the appearance of precipitates, insoluble
complexes or crystals.
The Instructions for Use of the medication to be added and other relevant literature
must be consulted.
Before adding a substance or medication, verify that it is soluble and/or stable in
water and that the pH range of 5% Dextrose w/v solution with Compound Sodium
Lactate is appropriate.(pH 4.0 to

When making additions to 5% Dextrose w/v solution with Compound Sodium
Lactate, aseptic technique must be used. Mix the solution thoroughly when
additives have been introduced. Do not store solutions containing additives.
As guidance the following medications are incompatible with the 5% Dextrose w/v
solution with Compound Sodium Lactate (non-exhaustive listing):
Medications incompatible with 5% Dextrose w/v solution with Compound Sodium
Lactate Aminocaproic acid Amphotericin B Ceftriaxone Cortisone acetate
Diethylstilbestrol Etamivan Ethyl alcohol Phosphate and carbonate solutions
Oxytetracycline Thiopental sodium Versenate disodium
Medications with partial incompatibility with 5% Dextrose w/v solution with
Compound Sodium Lactate: Tetracycline stable for 12 hours Ampicillin sodium
concentration of 2%-3% stable for 4 hours concentration >3% must be given
within 1 hour Minocycline stable for 12 hours Doxycycline stable for 6 hours
Additives known or determined to be incompatible should not be used.

2 years for NPVC bags. 4 years for Plastic bottle.

Do not store above 30 Co

The product is a clear, colorless solution in over wrapped Non-PVC Bag with two
SFC ports, poly ethylene plastic bottle.
NPVC Bag sizes: 1000ml.
Plastic bottles sizes: 500 ml and 1000 ml.

After opening the container, the contents should be used immediately and should
not be stored for a subsequent infusion.
Discard after single use. Discard any unused portion. Do not reconnect partially
used bags.

Return container to in use position, re-open the clamp and continue administration.
7. MARKETING AUTHORISATION HOLDER
Pharmaceutical Solutions Industry Ltd.
Industrial Estate, Phase-2,
Road No. 208, Str. - 203
P O Box 17476
Jeddah 21484
Western Province
Saudi Arabia
Phone: +966-12-6361383
FAX: +966-12-6379460
Website: http://www.psiltd.com