HARTMANNS

Posology Recommended dosage:

The amount of Compound Sodium Lactate solution (Ringer Lactate solution) needed to restore normal blood volume is 3 to 5 times the volume of lost blood. The recommended dosage depends on the weight, age and clinical condition. For routine maintenance of intravenous fluids, it is commonly within the following limits: - for adults: 500 ml to 3 litres/24 h - for paediatrics: 20 ml to 100 ml/kg/24 h.

Special clinical conditions, such as massive blood loss, burns, surgical drains, diarrhea, require additional adjustments of the necessary IV fluid volume. 8). Monitoring of serum sodium is particularly important for hypotonic fluids.

Administration rate:

The infusion rate is usually 40 ml/kg/24 h in adults. For calculating the intravenous fluid maintenance rate in adults, a “4-2-1” rule can be used: - 4 ml/kg/h for the first 10 kg of body weight, - 2 ml/kg/h for the second 10 kg of body weight, - 1 ml/kg/h for subsequent body weight.

For example, a 70 kg patient would require the following hourly maintenance fluid rate: 40+20+50=110 ml/h. 5-10 kg body weight (except newborns of 0- 28 days old), - 1000 ml + 50 ml for every kg over 10 kg for children of 11-20 kg weight, - 1500 ml + 20 ml/kg for every kg over 20 kg for children of >20 kg weight.

In patients with burns, the Parkland formula provides a basis for calculation of fluid requirements within the first 24 hours: 4 ml/kg/percentage of the body surface burned; onehalf to be given during the first 8 h and the second half in the next 16 h after the injury.

The volume may be adjusted according to the patient’s hemodynamic condition. Pediatric patients may require larger volumes, especially in the presence of inhalational injury. Therefore, the estimation of the necessary fluid resuscitation therapy should be based on the monitored hemodynamics parameters, such as urine output, mental status, lactate level and base deficit.

Less liquid volume should be infused in patients: - Having renal impairment, - Having cardiac failure, - Having severe hepatic insufficiency, especially with impaired lactate metabolism, - Elderly.

Method of administration:

During administration of Ringer Lactate solution, the following undesirable effects have been reported as: - very common: Allergic reactions or anaphylactic/anaphylactoid symptoms such as localized or generalized urticaria, skin rash & erythema and itching/pruritus; skin swelling, periobial facial and/or laryngeal oedema (Quincke's oedema).

Nasal congestion, coughing, sneezing, bronchospasm and/or difficulty breathing. - common: Chest tightness, chest pain, with tachycardia or bradycardia. Pruritus has been reported to occur in about 10% of patients receiving Ringer Lactate.

Hyperhydration and heart failure are very common in patients with cardiac disorder or pulmonary oedema. Electrolytes disturbances have been very commonly reported too. Lactate infusions commonly induce feelings of anxiety, and a few cases of panic attack have been reported.

5). Seizure may be precipitated by the alkalosis induced by lactate but this is uncommon. Adverse reactions may be associated with the technique of administration including febrile response, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

Adverse reactions may be associated to the medications added to the solution; the nature of the additive will determine the likelihood of any other undesirable effects. In case of undesirable effect(s), the infusion must be discontinued.

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

The patient's clinical status and laboratory parameters (blood and urine electrolytes as well as acid-base balance) must be monitored during use of this solution. The plasma potassium level of the patient must be particularly closely monitored in patients at risk of hyperkalaemia.

5). 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.

Although Ringer 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.

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 given cautiously to patients with impaired renal function, or disease associated with elevated vitamin D concentrations such as sarcoidosis.

They should be avoided in patients with calcium renal calculi, or a history of renal calculi. In case of concomitant blood transfusion and because of the presence of calcium, Ringer lactate solution must not be administered via the same infusion system because of the risk of coagulation.

Ringer lactate solution may cause metabolic alkalosis because of the presence of lactate ions. Ringer lactate solution may not produce its alkalinizing action in patients with liver insufficiency since lactate metabolism may be impaired.

The solution containing lactate should be administered with particular care to neonates less than 3 months old. During long term parenteral treatment, a convenient nutritive supply must be given to the patient. 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).

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