COMPOUND SODIUM LACTATE

8). Monitoring of serum sodium is particularly important for hypotonic fluids. g. 4. 8).

Recommended dosage:

The amount of 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 3 L/24h - for infants, toddlers and children: 20 ml to 100 ml/kg/24 h Administration rate: The infusion rate is usually 40 mL/kg/24h in adults.

Use in paediatric patients The safety and efficacy of 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.

Lactate- containing solutions should be administered with particular caution to neonates and infants less than 6 months of age. 3 mL/kg/percent 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.

Note: - infants and toddlers: aged from 28 days to 23 months (a toddler is an infant who can walk) - children: age from 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 product should be inspected visually for particulate matter and discoloration prior to administration.

Do not administer unless solution is clear, free from visible particles and the bag is intact. Administer immediately following the insertion of infusion set. 6. Additives may be introduced before infusion or during infusion through the injection port.

6.

The following adverse reactions (listed by MedDRA System Organ Class) have been reported spontaneously during the post-market experience. 2. 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 • Hypervolemia • Panic Attack • Other infusion site reactions: Infection at the site of injection, Extravasation, Infusion site anaesthesia (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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4. Compound Sodium Lactate 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

As for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and Compound Sodium Lactate is contraindicated in new-borns (≤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