SODIUM LACTATE RINGER'S INJECTION 500ML

Indications:

Sodium Lactate Ringers Injection is indicated to:

- Replace extracellular fluid losses,

- Restore the sodium, potassium, calcium and chloride balances, for treatment of isotonic dehydration

Dosage and Administration:

Posology

Adults, the Elderly, Adolescents and Children:

The dosage depends on the age, weight, clinical and biological conditions of the patient and concomitant therapy.

Recommended dosage:

The recommended dosage is:

- for adults, the elderly and adolescents : 500 ml to 3 litres /24h

- for babies and children : 20 ml to 100 ml / kg / 24 h.

Method of administration:

The administration is performed by intravenous route.

Monitoring

Fluid balance and plasma electrolytes concentrations (sodium, potassium, calcium and chlorides) must be monitored during administration.

Precautions & Warning:

Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborn infants aged less than 1 month have been described.

High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure.

Solutions containing sodium chloride should be administered with caution to patients with hypertension, heart failure, peripheral or pulmonary oedema, impaired renal function, pre-eclampsia, aldosteronism or other conditions or treatment (e.g. corticoids/steroids) associated with sodium retention.

Solutions containing potassium salts should be administered with caution to patients with cardiac disease, or conditions predisposing to hyperkalemia such as renal or adrenocortical insufficiency, acute dehydration, or extensive tissue destruction as occurs with severe burns.

Because of the presence of calcium:

- care should be taken to prevent extravasation during intravenous infusion

- the solution should be given cautiously to patients with impaired renal function or diseases associated with elevated vitamin D concentrations such as sarcoidosis

- in case of concomitant blood transfusion, the solution must not be administered via the same infusion set because of the risk of coagulation.

Sodium Lactate Ringers Injection contains insufficient concentration of potassium and calcium to be used for maintenance of these ions or to correct their deficits. Hence, after dehydration is treated, the IV fluid has to be changed to a maintenance fluid that will provide these ions.

Contra-indications:

The solution is contraindicated in patients presenting:

- Extracellular hyperhydration or hypervolemia

- Hypertonic dehydration

- Hyperkalemia

- Hypernatremia

- Hypercalcaemia

- Hyperchloraemia

- Severe renal insufficiency (with oliguria/anuria).

- Uncompensated cardiac failure

- Severe hypertension

- General oedema and ascitic cirrhosis

- Concomitant digitalis therapy

As for other calcium-containing infusion solutions , treatment with ceftriaxone and Sodium Lactate Ringers Injection is contraindicated in preterm newborn infants and term newborn infants (≤28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone calcium salt precipitation in the neonate's bloodstream).

Drug interactions:

Interaction with ceftriaxone

Interaction related to the presence of sodium

Interaction related to the presence of calcium

Storage instructions:

Do not store above 30°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.