Ringer's Injection

Product Name:Ringer’s solution

Nombre del Producto: Ringer's Solution

Specification: 500ml

Package: plastic bag,glass bottle

Standard: USP

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Details

Ringer's injection


Description

A colorless transparent liquid.

Indication

Ringer's Solution for Infusion is indicated to:

- Replace extracellular fluid losses

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

 

Dosage and Administration

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. In children with burns, the dose is on average 3.4 ml/kg/per cent burn at 24 h post-burn and 6.3 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.

Additives may be introduced before infusion or during infusion through the injection site.

Monitoring

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

 

Adverse Reaction

During administration of Ringer's solution, the adverse reactions have been reported as very common (≥ 10%):

- Hyperhydration and heart failure in patients with cardiac disorder or pulmonary oedema

- Electrolyte disturbances.

 

Contraindication

The solution is contraindicated in patients presenting:

- Extracellular hyperhydration or hypervolemia

- Hypertonic dehydration

- Hyperkalaemia

- Hypernatraemia

- Hypercalcaemia

- Hyperchloraemia.

- Severe renal insufficiency (with oliguria/anuria).

- Uncompensated cardiac failure

- Severe hypertension

- General oedema and ascitic cirrhosis

- Concomitant digitalis therapy.

 

Precautions

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 (see also Section 4.5 – 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 hyperkalaemia 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.

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.


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