Ringers Solution For Infusion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ringer's Solution for Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml of solution contains:
|
Sodium Chloride |
8.60 |
g |
|
Potassium Chloride |
0.30 |
g |
|
Calcium Chloride Dihydrate |
0.33 |
g |
|
Electrolyte concentrations: | ||
|
Sodium |
147 |
mmol/l |
|
Potassium |
4.0 |
mmol/l |
|
Calcium |
2.2 |
mmol/l |
|
Chloride |
156 |
mmol/l |
|
Theoretical osmolarity |
139 |
mOsm/l |
|
Titration acidity (to pH 7.4) |
< 1 |
mmol/l |
|
pH |
5.0 - 7.0 | |
For excipients see 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion A clear, colourless aqueous solution
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
- Fluid and electrolyte substitution in the condition of hypochloraemic alkalosis;
- Chloride losses;
- Isotonic or hypotonic dehydration;
Short-term intravascular volume replacement;
4.2 Posology and method of administration
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.
4.3 Contraindications
Ringer’s Solution for Infusion must not be administered to patients in states of:
- hyperhydration,
- hypertonic dehydration
- hyperchloraemia.
It must not be administered to patients receiving concomitant digitalis therapy (see section 4.5)
4.4
Special warnings and precautions for use
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.
4.5 Interactions with other medicinal products and other forms of interaction
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. potassiumsparing 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.
4.6 Pregnancy and lactation
Ringer’s Solution for Infusion can be given during pregnancy and lactation but should be used with caution in the presence of eclampsia.
4.7 Effects on ability to drive and use machines
Not applicable: Solution for intravenous infusion
4.8 Undesirable effects
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
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 overinfusion will be related to the nature of the additive being used.
In the event of accidental overinfusion, 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.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
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
5.2 Pharmacokinetic Properties
Administration of Ringer’s Solution for Infusion directly results in replenishment of the interstitial space which amounts to about /3 of the extracellular space. Only 1/3 of the administered volume stays in the intravascular space. Thus the solution has a short haemodynamic effect.
5.3 Preclinical Safety Data
Preclinical safety data are not relevant since its constituents are physiological components of animal and human plasma.
6.1 List of Excipients:
Water for Injections
6.2 Incompatibilities
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 colour 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.
6.3 Shelf Life
Shelf life of the medicinal product as packaged for sale
Unopened: 3 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.
6.4 Special Precautions for Storage
Unopened: This medicinal product does not require any special storage conditions.
6.5 Nature and Contents of Container
Polyethylene bottles,
contents: 500 ml, 1000 ml in packs of 10.
6.6 Instructions for Use and Handling
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.
7. MARKETING AUTHORISATION HOLDER
B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen, Germany
8. MARKETING AUTHORISATION NUMBER
PL 03551/0087
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/01/2009
10 DATE OF REVISION OF THE TEXT
07/10/2014