RINGERS

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

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.

Administration rate:

The infusion rate is usually 40 ml/kg/24h in adults, the elderly and adolescents. In paediatric patients the infusion rate is 5 ml/kg/h on average but the value varies with age: 6-8 ml/kg/h for infants, 4-6 ml/kg/h for toddlers, and 2-4 ml/kg/h for schoolchildren.

3 ml/kg/per cent 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 and schoolchildren: aged from 2 years to 11 years.

Method of administration:

The administration is performed by intravenous route. The solution for infusion should be visually inspected prior to use. Use only if the solution is clear, without visible particles and if the container is undamaged. Administer immediately following the insertion of infusion set.

Do not remove unit from overwrap until ready for use. The inner bag maintains the sterility of the product. Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.

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. The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.

The following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible. Tabulated list of adverse reactions MedDRA System Organ Class Adverse Reactions (Preferred term) Frequency Metabolism and nutrition disorders Hyperhydration* Electrolytes disturbances Hospital acquired hyponatraemia** Very common Very common Not known Cardiac disorders Heart failure* Very common Nervous system Disorders Acute hyponatraemic encephalopathy** Not known * in patients with cardiac disorder or pulmonary oedema **Hospital acquired hyponatraemia may cause irreversible brain injury and death due to development of acute hyponatraemic encephalopathy Fluid overload, hypersensitivity and urticaria have been reported with other similar solutions.

Adverse reactions may be associated to 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 and extravasation.

Adverse reactions may be associated to the medicinal product added to the solution; the nature of the additive will determine the likelihood of any other adverse reactions. In case of adverse reaction(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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

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Ringer’s Solution for Infusion 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.

During long-term parenteral treatment, a convenient nutritive supply must be given to the patient. Depending on the volume and rate of infusion, intravenous administration of Ringer’s Solution can cause fluid retention and or/solute overload resulting in overhydration and for example, congested states, including pulmonary congestion and edema.

g. 5 – Interactions with other medicinal products and other forms of interaction). 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.

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).

g. 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. 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.

The solution is contraindicated in patients presenting with: - Extracellular hyperhydration or hypervolemia - Hypertonic dehydration - Hyperkalemia - Hypernatremia - Hypercalcaemia - Hyperchloraemia - Severe renal insufficiency (with oliguria/anuria).

5) As for other calcium-containing infusion solutions, treatment with ceftriaxone and Ringer's Solution for Infusion 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).