Therapeutic indications
– Fluid and electrolyte substitution in the condition of hypochloremia
alkalosis;
– Chloride losses;

– Isotonic or hypotonic dehydration;
– Short-term intravascular volume replacement;

Adults and the elderly
Recommended dosage schedule:
The dose and rate of infusion are adjusted according to the weight, actual
requirements of water and electrolytes and the clinical condition of the patient,
especially renal and cardiovascular status. Monitoring of serum electrolytes is
essential.
Maximum daily dose:
40 ml/kg BW, corresponding to 6 mmol of sodium per kg BW
Infusion rate:
Up to 5 ml/kg BW/hour.
In the management of shock higher volumes and higher rates of infusion may be
administered.

In patients with chronic hyponatraemia the rate of infusion should be slow, so
that the resulting increase of the serum sodium level is limited to a maximum
of 0.35 mmol/l/h.
Children
In children the posology for adults should be used as a guide.
Method of administration
Intravenous infusion.
This container contains a significant volume of air. To avoid risk of air embolism,
expel all air before pressure infusion.

Ringer’s Solution for Infusion must not be administered to patients in states of: – hyperhydration, – hypertonic dehydration – hyperchloremia. It must not be administered to patients receiving concomitant digitalis therapy (see section 4.5)

Special warnings
Ringer’s Solution for Infusion should only be administered with particular caution in
the following conditions:
- Hyperkalaemia
- Hypernatraemia,
- Renal insufficiency with a tendency towards hyperkalaemia,
- Disorders where restriction of sodium intake is indicated, such as cardiac
insufficiency, generalised oedema, pulmonary oedema, hypertension, eclampsia,
severe renal insufficiency.

Solutions containing potassium salts should be administered with caution to
patients with cardiac disease.
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 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.
Precautions for use
Clinical supervision should include checks of the serum electrolytes and the
water balance.

Corticosteroids are associated with the retention of sodium and water (with
oedema and hypertension).
Solutions containing potassium should be used with caution in patients receiving
drugs that increase serum potassium concentrations (e.g. potassium sparing
diuretics, ACE inhibitors, cyclosporin and tacrolimus).

Hypercalcemia may occur in patients receiving concomitant thiazide diuretics
or vitamin D.
Calcium enhances the effects of digitalis glycosides on the heart and may
precipitate digitalis intoxication.

Ringer’s Solution for Infusion can be given during pregnancy and lactation but
should be used with caution in the presence of eclampsia.

Not applicable: Solution for intravenous infusion

The following undesirable effects have been reported:
- Hyperhydration and heart failure in patients with cardiac or pulmonary oedema
- Electrolytes disturbances
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 and
extravasation.
Adverse reactions may be associated with the medications added to the solution;
the nature of the additive will determine the likelihood of any other undesirable
effects.

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 at:

Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000

E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States:
Please contact the relevant competent authority.

Overdose may lead to water and sodium overload with a risk of oedema,
particularly when there is a defective renal sodium excretion. In this case dialysis
may be necessary.
Excessive administration of potassium may lead to the development of
hyperkalemia, especially in patients with renal impairment. Symptoms include
paresthesia of the extremities, muscle weakness, paralysis, cardiac arrhythmias,
heart block, cardiac arrest, and mental confusion. Treatment of hyperkalemia
involves the administration of calcium, insulin (with glucose), sodium bicarbonate,
exchange resins or dialysis.
Excessive administration of calcium salts may lead to hypercalcemia. Symptoms of
hypercalcemia may include anorexia, nausea, vomiting, constipation, abdominal
pain, muscle weakness, mental disturbances, polydipsia, polyuria,
nephrocalcinosis, renal calculi, and, in severe cases, cardiac arrhythmias and coma.
Too rapid intravenous injection of calcium salts may also lead to many of the
symptoms of hypercalcemia as well as to chalky taste, hot flushes, and peripheral
vasodilatation. Mild asymptomatic hypercalcemia will usually resolve on stopping

administration of calcium and other contributory drugs such as vitamin D. If
hypercalcemia is severe, urgent treatment (such as loop diuretics, hemodialysis,
calcitonin, bisphosphonates, trisodium edetate) is required.
Excessive administration of chloride salts may cause a loss of bicarbonate with an
acidifying effect.
When overdose is related to medications added to the solution infused, the signs
and symptoms of over-infusion will be related to the nature of the additive being
used.
In the event of accidental over-infusion, treatment should be discontinued and the
patient should be observed for the appropriate signs and symptoms related to the
drug administered. The relevant symptomatic and supportive measures should be
provided as necessary.

Ringer’s Solution for Infusion has a similar electrolyte composition as the
extracellular fluid. It is used for correction of serum electrolyte and acid-base
imbalances. Electrolytes are administered in order to achieve or to maintain a
normal osmotic situation in both the extra- and the intracellular space. Due to its
relatively high chloride content the solution has a mild acidifying effect.

Administration of Ringer’s Solution for Infusion directly results in replenishment of
the interstitial space which amounts to about 2/3 of the extracellular space. Only
1/3 of the administered volume stays in the intravascular space. Thus, the solution
has a short hemodynamic effect.

Preclinical safety data are not relevant since its constituents are physiological
components of animal and human plasma

Water for Injections

Drugs containing oxalate, phosphate, or carbonate/bicarbonate may cause
precipitation upon mixing with Ringer’s Solution for Infusion.
No other medicament or substance should be added to the fluid unless known to
be compatible. As with all parenteral solutions, before adding medications,
compatibility of these additives with the product in the container must be assessed.
It is the responsibility of the physician to judge the incompatibility of an additive
medication with the Ringer’s solution for infusion by checking for eventual color
change and/or eventual precipitate, insoluble complexes or crystals apparition.
The Instructions for Use of the medication to be added must be consulted.
Before adding a drug, verify it is soluble and stable in water at the pH of Ringer’s
Solution for Infusion.

When a compatible medication is added to this formulation, the solution must be
administered immediately.

Calcium salts have been reported to be incompatible with a wide range of drugs.
Complexes may form resulting in the formation of a precipitate.
As a guidance, the following medications are incompatible with the Ringer’s
solution (non-exhaustive listing):
- Amphotericin B
- Cortisone
- Erythromycin lactobionate
- Etamivan
- Ethyl alcohol
- Thiopental sodium
- Disodium edetate
Those additives known to be incompatible should not be used.

 

Shelf life of Plastic Bottle as packaged for sale Unopened: 4 years Shelf life of NON-PVC Bags as packaged for sale Unopened: 2 years Shelf life after first opening the container: Not applicable. Product should be administered immediately after connecting to the giving set. In-use shelf-life (Additives) Chemical and physical stability of any additive medication at the pH of the Ringer’s Solution in the container should be established prior to use. From a microbiological point of view, the diluted product should be used immediately and infusion completed within 24 hours of the addition of any additive. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

Unopened: Store below 30°C.

Polyethylene bottles, contents: 500 ml, 1000 ml

NON-PVC Bags, contents: 1000ml

Use only if the solution is clear, without visible particles and if the container is
undamaged.
The solution should not be administered if the container or its closure show visible
signs of damage.
For single use only. Discard unused contents. Do not reconnect partially used
containers.
Administer immediately following the insertion of infusion set.
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.
When additive is used verify isotonicity prior to parenteral administration. Thorough
and careful aseptic mixing of any additive is mandatory. Solutions containing
additives should be used immediately after preparation unless preparation has
taken place in controlled and validated aseptic conditions.

In case of an adverse reaction, infusion must be stopped immediately.