Compound Sodium Lactate solution is used in the following indications:
- Restoration of extracellular fluid and electrolytes balances 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
hypovolaemia or hypotension.
- Regulation or maintenance of metabolic acidosis balance and/or treatment of mild
to moderate metabolic acidosis (except lactic acidosis)

Posology
Adults, the Elderly and Children:
Fluid balance, serum electrolytes and acid-base balance should be monitored
before and during administration, with particular attention to serum sodium in
patients with increased non-osmotic vasopressin release (syndrome of
inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated
with vasopressin agonist drugs, due to the risk of hospital acquired hyponatraemia
(see sections 4.4, 4.5 and 4.8). Monitoring of serum sodium is particularly
important for hypotonic fluids.

Compound Sodium Lactate solution has a tonicity of 278 mOsm/l (approx.)
The infusion rate and volume depend on the age, weight, clinical condition (e.g.
burns, surgery, head-injury, infections), and concomitant therapy should be
determined by the consulting physician experienced in intravenous fluid therapy
(see sections 4.4. and 4.8).

Recommended dosage:
The amount of Compound Sodium Lactate solution needed to restore normal blood
volume is 3 to 5 times the volume of lost blood.
Dosage
The recommended flow rate 2.5 ml/kg BW/h.i.e
60 Drops/minute or 180 ml/h /70kg BW

Use in paediatric patients
The safety and efficacy of Compound Sodium Lactate solution 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. Lactate-containing solutions should be administered with particular
caution to neonates and infants less than 6 months of age.

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.
Additives may be introduced before infusion or during infusion through the
injection site. When making additions to Compound Sodium Lactate solution,
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 Compound Sodium Lactate solution is contraindicated in newborns (≤28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxonecalcium salt precipitation in the neonate's bloodstream). For patients over 28 days of age please see section 4.4. Compound Sodium Lactate solution is also contraindicated in patients with • A known hypersensitivity to sodium lactate. • Extracellular hyperhydration or hypervolaemia • Severe renal insufficiency (with oliguria/anuria) • Uncompensated cardiac failure • Hyperkalaemia • Hypercalcaemia • Metabolic alkalosis • Ascitic cirrhosis • Severe metabolic acidosis • Conditions associated with increased lactate levels (hyperlactataemia) 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)

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.
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 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.

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 acid-base 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 eg
acetazolamide) or steroids (androgens, estrogens corticosteroids) and in patients
with severe dehydration.

Use in patients with potassium deficiency
Although Compound Sodium Lactate solution 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
Compound Sodium Lactate solution 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 avoided.
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
Compound Sodium Lactate solution should be administered with particular caution
to patients with renal impairment. In such patients administration of Compound
Sodium Lactate solution 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
Compound Sodium Lactate solution can cause
• fluid and/or solute overload resulting in overhydration and, for example,
congested states, including pulmonary congestion and oedema.
• clinically relevant electrolyte disturbances and acid-base imbalance.
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.

High volume infusion must be used under specific monitoring in patients with
cardiac or pulmonary failure and in patients with non-osmotic vasopressin release
(including SIADH), due to the risk of hospital-acquired hyponatraemia (see
below).
Hyponatraemia
Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, postoperative
stress, infections, burns, and CNS diseases), patients with heart-, liverand
kidney diseases and patients exposed to vasopressin agonists (see section 4.5)
are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids.
Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral
oedema) characterized by headache, nausea, seizures, lethargy and vomiting.

Patients with cerebral oedema are at particular risk of severe, irreversible and lifethreatening
brain injury.
Children, women in the fertile age and patients with reduced cerebral compliance
(e.g. meningitis, intracranial bleeding, cerebral contusion and brain oedema) are at
particular risk of the severe and life-threatening brain swelling caused by acute
hyponatraemia.
Use in patients with hypervolaemia, overhydration or conditions causing sodium
retention and oedema
Compound Sodium Lactate solution should be administered with particular caution
to hypervolaemic or overhydrated patients.
Due to the sodium chloride content Compound Sodium Lactate solution should be
administered with particular caution to patients with conditions that may cause
sodium retention, fluid overload and oedema, 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 4.5)

Acid-base balance
Use in patients at risk for alkalosis
Compound Sodium Lactate solution 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.

Other warnings
Administration of citrate anticoagulated/preserved blood
Due to the risk of coagulation precipitated by its calcium content, Compound
Sodium Lactate solution must not be added to or administered simultaneously
through the same tubing with citrate anticoagulated/preserved blood.
Use in patients with type 2 diabetes
Lactate is a substrate for gluconeogenesis. Therefore, glucose levels should be
carefully monitored in patients receiving Compound Sodium Lactate.
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.
During long term parenteral treatment, a convenient nutritive supply must be given
to the patient.

 

Ceftriaxone: See sections 4.3 and 4.4 for more information
Drugs leading to an increased vasopressin effect
The below listed drugs increase the vasopressin effect, leading to reduced renal
electrolyte free water excretion and may increase the risk of hospital acquired
hyponatraemia following inappropriately balanced treatment with i.v. fluids (see
sections 4.2, 4.4 and 4.8).
• Drugs stimulating vasopressin release include: Chlorpropamide, clofibrate,
carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-
methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, and narcotics.
• Drugs potentiating vasopressin action include: Chlorpropamide, NSAIDs, and
cyclophosphamide
• Vasopressin analogues include: Desmopressin, oxytocin, terlipressin
Other medicinal products increasing the risk of hyponatraemia also include

diuretics in general and antiepileptics such as oxcarbazepine.
Interaction related to the presence of sodium:
Caution is advised when administering Compound Sodium Lactate solution 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, Compound Sodium Lactate solution 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, cyclosporine

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 Compound Sodium Lactate solution to
patients treated with thiazide diuretics or vitamin D, as these can increase the risk
of hypercalcaemia.
- 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 Compound Sodium Lactate solution to
patients treated with drugs for which renal elimination is pH dependent. Due to the
alkalinizing action of lactate (formation of bicarbonate), Compound Sodium
Lactate solution 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

 

Compound Sodium Lactate solution can be used safely during pregnancy and
lactation as long as the electrolyte- and fluid balance is controlled.
It is reminded that calcium crosses the placenta and is distributed into breast milk.
Compound Sodium Lactate solution should be administrated with special caution
for pregnant women during labour particularly as to serum-sodium if administered
in combination with oxytocin (see section 4.4, 4.5 and 4.8).
When a medication is added, the nature of the drug and its use during pregnancy
and lactation have to be considered separately.

There is no information of the effects of Compound Sodium Lactate solution 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.

Immune System Disorders	Hypersensitivity/Infusion reactions including Anaphylactic/Anaphylactoid reaction, possibly manifested by one or more of the following
	symptoms: Angioedema, Chest pain, Chest discomfort, Decreased heart rate, Tachycardia, Blood pressure decreased, Respiratory distress, Bronchospasm, Dyspnea, Cough, Urticaria, Rash, Pruritus, Erythema, Flushing, Throat irritation, Paresthesias, Hypoesthesia oral, Dysgeusia, Nausea, Anxiety, Pyrexia, Headache
Metabolism and Nutrition Disorders	Hyperkalaemia Hospital acquired hyponatraemia*
Nervous system disorders	Acute hyponatraemic encephalopathy*
General Disorders and Administration Site Conditions	Infusion Site Reactions manifested by one or more of the following symptoms: Phlebitis, Infusion site inflammation, Infusion site swelling, Infusion site rash, Infusion site pruritus, Infusion site erythema, Infusion site pain, Infusion site burning

*Hospital acquired hyponatraemia may cause irreversible brain injury and death,
due to development of acute hyponatraemic encephalopathy, frequency unknown
(see sections 4.2. 4.4, 4.5).
The following adverse reactions have been reported spontaneously during the use
of other sodium-lactate containing solutions:
• Hypersensitivity: Laryngeal oedema (Quincke's oedema), skin swelling, Nasal
congestion, Sneezing
• Electrolyte disturbances
• Hypervolaemia
• Panic Attack
• Other infusion site reactions: Infection at the site of injection, Extravasation,
Infusion site anesthesia (numbness)

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.

 

 

 

An excessive volume or too high a rate of administration of Compound Sodium
Lactate solution may lead to fluid and sodium overload with a risk of oedema
(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
hyperkalaemia, 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 hypercalcaemia. Symptoms
of hypercalcaemia 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 hypercalcaemia as well as to chalky taste, hot flushes, and peripheral
vasodilatation. Mild asymptomatic hypercalcaemia will usually resolve on
stopping administration of calcium and other contributory drugs such as vitamin D.
If hypercalcaemia is severe, urgent treatment (such as loop diuretics,
haemodialysis, calcitonin, bisphosphonates, trisodium edetate) is required.

Excessive administration of lactate may lead to metabolic alkalosis. Metabolic
alkalosis may be accompanied by hypokalaemia, Symptoms may include mood
changes, tiredness, shortness of breath, muscle weakness and irregular heartbeat.
Muscle hypertonicity, twitching, and tetany may develop especially in
hypocalcaemic 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.

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): B05BB01 “Electrolytes”

Compound Sodium Lactate solution is an isotonic solution of electrolytes. The
constituents of Compound Sodium Lactate Solution and their concentrations are
designed to match those of plasma.
The pharmacological properties of the Compound Sodium Lactate solution are
those of its components (sodium, potassium, calcium, chloride and lactate). The
main effect of Compound Sodium Lactate Solution 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 Solution, central
venous pressure changes were associated with a secretion of atrial natriuretic
peptide
In healthy volunteers, Compound Sodium Lactate Solution decreased serum
osmolality, increased blood pH, and the time until first urination was shorter than that with normal saline.

There is no significant change in glucagon, norepinephrine, epinephrine, blood
glucose and insulin levels in aortic surgery patients receiving Compound Sodium
Lactate Solution.
When medication is added to Compound Sodium Lactate Solution, the overall
pharmacodynamics of the solution will depend on the nature of the drug used.

 

The pharmacokinetic properties of the Compound Sodium Lactate solution are
those of the ions its composition includes (sodium, potassium, calcium and
chloride).
Infusion of Compound Sodium Lactate Solution 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 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 Compound Sodium Lactate Solution, the overall
pharmacokinetics of the solution will depend on the nature of the drug used.

Preclinical safety data of Compound Sodium Lactate 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
Compound Sodium Lactate solution. 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 solution and Viaflo container
must be assessed before addition. After addition of the additive, incompatibility
may become visible by 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 Compound Sodium Lactate solution is appropriate
(pH 5.0 to 7.0).
When making additions to Compound Sodium Lacate solution, aseptic technique
must be used. Mix the solution thoroughly when additives have been introduced.
Do not store solutions containing additives.

As a guidance the following medications are incompatible with the Compound
Sodium Lactate solution (non-exhaustive listing):
Medications incompatible with Compound Sodium Lactate Solution
Aminocaproic acid
Amphotericin B
Metaraminol tartrate
Cefamandole
Ceftriaxone
Cortisone acetate
Diethylstilbestrol
Etamivan
Ethyl alcohol
Phosphate and carbonate solutions
Oxytetracycline

Thiopental sodium
Versenate disodium
Medications with partial incompatibility with Compound Sodium Lactate Solution:
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.

48 months for plastic bottle. 24 months for NPVC bag.

Do not store above 30°C
Do not store above 25°C for sizes: 250 ml NPVC bag.

The product is a clear, colorless solution in over wrapped Non-PVC Bag with two
SFC ports and Polyethylene plastic bottle.
The solutions are supplied in 250ml, 500 ml, 1000 ml and 3000 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.