Roztvur Ringera

Leaflet attached to the packaging: information for the patient and user

Ringer's Solution

(Sodium chloride + Potassium chloride + Calcium chloride)
infusion solution (8.6 mg + 0.3 mg + 0.33 mg)/ml

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor, pharmacist, or nurse if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their illness symptoms are the same.
• If any of the side effects worsen or if any side effects not mentioned in the leaflet occur, you should tell your doctor, pharmacist, or nurse.

Table of contents:

• 1. What is Ringer's Solution and what is it 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. Package contents and other information

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

Ringer's Solution is a sterile, clear, colorless aqueous solution used in cases of:

• replenishing fluids and electrolytes in hypochloremic alkalosis;
• loss of chlorides;
• isotonic or hypotonic dehydration;
• short-term intravascular volume replenishment;
• diluent for compatible electrolyte or drug concentrates.

2. Important information before using Ringer's Solution

Ringer's Solution must not be administered to patients with conduction.

Use Ringer's Solution with caution

Ringer's Solution should be administered with caution in the following situations:

• hypertonic dehydration;
• hyperkalemia;
• hypernatremia;
• hyperchloremia;
• renal failure with a tendency to hyperkalemia;
• disorders where sodium intake is recommended to be restricted, such as heart failure, generalized edema, pulmonary edema, hypertension, eclampsia, and severe renal failure.

Recommended precautions

Clinical monitoring should include control of serum ionogram and water balance.
If the solution is to be administered by pressure method (using, for example, a pressure cuff or infusion pump), before starting the infusion, ensure that all air is removed from the container and infusion system.

Using other medicines

No pharmacological interactions have been found.
If other medicines are to be added to the solution, their compatibility with the solution should be considered.

Pregnancy or breastfeeding

Before using any medicine, consult a doctor. Ringer's Solution can be administered during pregnancy and breastfeeding, but caution should be exercised in case 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.
Administration rate: maximum 5 ml per hour per kg of body weight, which corresponds to a maximum of 1.7 drops per minute per kg of body weight.
Children and the elderly
According to individual needs.
If Ringer's Solution is used as a diluent, the instructions for administering the diluted medicine should be followed.
Administration method
Intravenous administration.
Information on precautions for pressure infusion can be found in the Recommended precautionssection above.
General guidelines for administering body fluids and electrolytes
A fluid intake of 30 ml/kg body weight only covers the basic physiological need for fluids. Patients in the postoperative period and those requiring intensive therapy have increased fluid needs due to limited renal ability to concentrate urine and increased excretion of metabolites, so it is necessary to increase fluid intake to approximately 40 ml per kilogram of body weight per day. Additional losses (due to fever, diarrhea, fistulas, vomiting, etc.) must be compensated for by an even higher, individually tailored fluid intake.
In each case, the current and individual need for fluids must be related to monitoring diuresis, serum and urine osmolality, and determination of excreted substances.
The basic intake 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 current need depends on the proper determination of electrolyte balance and the level determined by laboratory tests in the serum.

In case of overdose of Ringer's Solution:

Symptoms
Overdose may cause overhydration with increased skin tension, vein filling, edema - including pulmonary and cerebral edema, electrolyte disturbances, hyperosmolality of serum, and metabolic acidosis.
Emergency measures, antidotes
Discontinuation of infusion, administration of diuretics, constant monitoring of serum electrolyte concentrations, correction of electrolyte disturbances and acid-base balance.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although they may not occur in everyone.
During administration, hyperchloremia may occur.

Reporting side effects

If any side effects occur, including any side effects not mentioned in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al.
Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Ringer's Solution

The medicine should be stored in a place inaccessible and invisible to children.
You should not use Ringer's Solution after the expiry date stated on the packaging.
There are no special precautions for storing the medicinal product.

6. Package contents and other information

To obtain more detailed information, you should contact a representative of the responsible entity.
Poland
Aesculap Chifa Sp. z o.o.
ul. Tysiąclecia 14
64-300 Nowy Tomyśl
phone: (0-61) 44 20 100
1000 ml of the 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
Chlorides
156
mmol/l
Theoretical osmolality
309
mOsm/1
Titration acidity
<0,3 mmol/l
pH
5.0-7.0
The packaging contains:
500 ml glass bottles with rubber stoppers
in a cardboard box
10 x 500 ml
500 ml or 1000 ml Ecoflac plus polyethylene containers
in a cardboard box
10 x 500 ml
10 x 1000 ml

Responsible entity with a permit for marketing authorization

Manufacturer

• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany

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

• B. Braun Avitum AG Schwarzenberger Weg 73-79 34212 Melsungen Germany
• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany

Date of last update of the leaflet:2023-04-19