Ringer's solution

Patient and user information leaflet

Ringer's Solution
(Sodium chloride + Potassium chloride + Calcium chloride)
infusion solution (8.6 mg + 0.3 mg + 0.33 mg)/ml
Please read the entire leaflet before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others.
• This medicine may harm others, even if their symptoms are identical.
• If any adverse reactions worsen or if any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Table of contents:

1. What Ringer's Solution is and what it is used for
2. Important information before using Ringer's Solution
3. How to use Ringer's Solution
4. Possible side effects
5. How to store Ringer's Solution
6. Contents of the pack and other information

1. What Ringer's Solution is and what it is used for

Ringer's Solution is a sterile, clear, colourless aqueous solution used in the following situations:

• fluid and electrolyte replacement in hypochloraemic alkalosis;
• chloride loss;
• isotonic or hypotonic dehydration;
• short-term intravascular volume replacement;
• as a diluent for compatible electrolyte concentrates or medicinal products.

2. Important information before using the medicinal product Ringer's Solution

Ringer's Solution must not be administered to patients who are dehydrated.
Special caution must be exercised when administering Ringer's Solution
Ringer's Solution should be administered with particular caution in the following conditions:

• hypertonic dehydration;
• hyperkalemia;
• hypernatremia;
• hyperchloremia;
• renal failure with a tendency towards hyperkalemia;
• disorders in which sodium intake should be restricted, such as cardiac failure, generalized edema, pulmonary edema, hypertension, eclampsia, severe renal failure.

Recommended precautions
Clinical monitoring should include plasma electrolyte control and water balance assessment.
If the solution is to be administered under pressure (using, for example, a pressure cuff or infusion pump), care must be taken before starting the infusion to completely remove air from the container and infusion system.
Use with other medicinal products
No pharmacological interactions have been reported.
If other medicinal products are to be added to the solution, their compatibility with the solution must be considered.
Pregnancy or breastfeeding
Consult a physician before using any medicinal product. Ringer's Solution may be administered during pregnancy and breastfeeding, but caution should be exercised in cases of eclampsia.
Driving and operating machinery
Not applicable

3. How to use Ringer's Solution

Dosage
The dosage of Ringer's Solution depends on the patient's age, body weight, and clinical condition.
General guidelines for adults
Up to 40 ml per day per kg of body weight.
Rate of administration: maximum 5 ml per hour per kg of body weight, corresponding to a maximum
of 1.7 drops per minute per kg of body weight.
Children and elderly patients
According to individual needs.
If Ringer's Solution is used as a diluent, follow the instructions for administration of the drug being diluted.
Method of administration
Intravenous administration.
Information regarding precautions for pressure infusion is provided in the Recommended
precautions section above.
General guidelines for administration of body fluids and electrolytes
A fluid intake of 30 ml/kg body weight covers only the physiological basal fluid requirement.
Postoperative patients and those requiring intensive therapy have increased fluid requirements due to limited renal ability to concentrate urine and increased excretion of metabolites; therefore, fluid administration should be increased to approximately 40 ml per kilogram of body weight per day. Additional losses (caused by fever, diarrhea, fistulas, vomiting, etc.) must be compensated by even higher, individually adjusted fluid administration.
In every case, the current and individual fluid requirement must be correlated with monitoring of diuresis, serum and urine osmolality, and determination of excreted substances.
The basal supply of the most important cations, sodium and potassium, is approximately 1.5–3 mmol/kg body weight per day and 0.8–1.0 mmol/kg body weight per day, respectively. During infusion, the actual requirement depends on proper assessment of electrolyte balance and on laboratory-determined serum levels.
In case of administration of a higher dose of Ringer's Solution than recommended:
Symptoms
Overdose may cause overhydration with increased skin turgor, venous distension, edema—including pulmonary and cerebral edema—electrolyte disturbances, hyperosmolality of plasma, and metabolic acidosis.
Management in emergencies, antidote
Discontinue infusion, administer diuretics, continuously monitor plasma electrolyte concentrations, and correct electrolyte imbalances and acid-base equilibrium.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Hyperchloremia may occur during administration.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products at:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ringer's Solution

Keep this medicine out of the sight and reach of children.
Do not use Ringer's Solution after the expiry date stated on the packaging.
There are no special storage instructions for this medicinal product.

6. Contents of the package and other information

For more detailed information, please contact the representative of the marketing authorisation holder.
Poland
Aesculap Chifa Sp. z o.o.
Tysiąclecia 14 Street
64-300 Nowy Tomyśl
Phone: (0-61) 44 20 100

1000 ml of solution contains:
Sodium chloride 8.60 g
Potassium chloride 0.30 g
Calcium chloride dihydrate 0.33 g
Water for injections

Electrolyte concentrations
Sodium 147 mmol/l
Potassium 4.0 mmol/l
Calcium 2.2 mmol/l
Chloride 156 mmol/l
Theoretical osmolarity 309 mOsm/l
Titratable acidity < 0.3 mmol/l
pH 5.0–7.0

Packaging contains:
Glass bottles with rubber stoppers, capacity 500 ml,
in cardboard box 10 x 500 ml
Polyethylene containers of Ecoflac plus type, capacity 500 ml or 1000 ml,
in cardboard box 10 x 500 ml
10 x 1000 ml

Marketing Authorisation Holder Manufacturer
B. Braun Melsungen AG B. Braun Melsungen AG
Carl-Braun-Strasse 1 Carl-Braun-Strasse 1
34212 Melsungen 34212 Melsungen
Germany Germany

B. Braun Medical SA
Carretera de Terrassa, 121
08191 Rubi (Barcelona)
Spain

B. Braun Avitum AG
Schwarzenberger Weg 73-79
34212 Melsungen
Germany