Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use

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 Ringer 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
Ringer 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.
Ringer 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
Ringer 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.
Ringer 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 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.

Use in patients at risk for hyperkalaemia
Ringer 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
Ringer Lactate solution should be administered with particular caution to patients with renal impairment. In such patients, administration of Ringer 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 Ringer 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, post-operative stress, infections, burns, and CNS diseases), patients with heart-, liver- and 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 life-threatening 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 severe and life-threatening brain swelling caused by acute hyponatraemia.

Use in patients with hypervolaemia, overhydration or conditions causing sodium retention and oedema
Ringer Lactate solution should be administered with particular caution to hypervolaemic or overhydrated patients.
Due to the sodium chloride content, Ringer 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
Ringer 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, Ringer 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 Ringer 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.

This medicinal product contains 301.3 mg sodium per 100 ml, equivalent to 15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This medicine contains 0.536 mmol (or 20.95 mg) potassium per 100 ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.


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