P 8.6 mg/0.3 mg/0.33 mg Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
2. What is RINGER'S SOLUTION FRESENIUS and what is it used for
3. Important information before using RINGER'S SOLUTION FRESENIUS
   1. When not to use RINGER'S SOLUTION FRESENIUS
   2. Warnings and precautions
   3. RINGER'S SOLUTION FRESENIUS and other medicines
   4. Pregnancy and breast-feeding
   5. Driving and using machines
4. How to use RINGER'S SOLUTION FRESENIUS
   1. Use of a higher than recommended dose of RINGER'S SOLUTION FRESENIUS
5. Possible side effects
   1. Very common (may affect more than 1 in 10 people):
   2. Common (may affect up to 1 in 10 people):
   3. Frequency not known (cannot be estimated from the available data):
   4. Reporting side effects
6. How to store RINGER'S SOLUTION FRESENIUS
7. Contents of the pack and other information
   1. What RINGER'S SOLUTION FRESENIUS contains
   2. What RINGER'S SOLUTION FRESENIUS looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet:
   7. Information intended exclusively for healthcare professionals:
   8. Dosage and administration
   9. Overdose
   10. Interactions with other medicines and other types of interactions
   11. Preparation of the medicine for use
   12. Note: The ports are sterile, do not require disinfection before first use.
   13. Incompatibilities
   14. Disposal of unused medicine

Package Leaflet: Information for the User

RINGER'S SOLUTION FRESENIUS, (8.6 mg + 0.3 mg + 0.33 mg)/ml, solution for infusion
Sodium chloride + Potassium chloride + Calcium chloride dihydrate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is RINGER'S SOLUTION FRESENIUS and what is it used for
• 2. Important information before using RINGER'S SOLUTION FRESENIUS
• 3. How to use RINGER'S SOLUTION FRESENIUS
• 4. Possible side effects
• 5. How to store RINGER'S SOLUTION FRESENIUS
• 6. Contents of the pack and other information

1. What is RINGER'S SOLUTION FRESENIUS and what is it used for

RINGER'S SOLUTION FRESENIUS is an aqueous solution of mineral salts (sodium, potassium, calcium)
used to fill the vascular bed and restore the water-electrolyte balance of the body. The composition of the drug is very similar to the composition of the extracellular fluid in the body. The drug is administered intravenously.
Indications for use:

• dehydration, regardless of the cause (vomiting, diarrhea, fistulas, etc.);
• hypovolemia (too small a blood volume in the blood vessels) resulting from:
• burns;
• loss of water and/or electrolytes after surgical procedures;
• hypovolemic shock - for initial filling of the vascular bed.

RINGER'S SOLUTION FRESENIUS can be used to dilute and dissolve electrolyte concentrates and drugs that do not show incompatibility.

2. Important information before using RINGER'S SOLUTION FRESENIUS

When not to use RINGER'S SOLUTION FRESENIUS

Do not use RINGER'S SOLUTION FRESENIUS:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you have an excess of fluid in the body (you are overhydrated).

The use of the medicine may be contraindicated:

• if you have congestive heart failure (heart function disorders manifested by e.g. swelling in the ankles, pulmonary edema);
• if you have too high a concentration of sodium, chloride, potassium, or calcium in the blood;
• in situations where you should limit your sodium intake (e.g. due to severe kidney failure, pulmonary edema);
• concomitantly with digitalis glycosides and potassium-sparing diuretics (see section: RINGER'S SOLUTION FRESENIUS and other medicines).

Warnings and precautions

During the administration of RINGER'S SOLUTION FRESENIUS, the doctor will monitor the patient's condition
and order blood tests (to check if there is no disturbance of fluid balance, electrolyte concentration, and acid-base balance), especially if the patient:

• has congestive heart failure;
• has severe kidney failure;
• has edema caused by sodium retention in the body;
• is being treated with corticosteroids and their derivatives (see section: RINGER'S SOLUTION FRESENIUS and other medicines).

RINGER'S SOLUTION FRESENIUS will be administered with caution due to the risk of:

• complications dependent on the volume of the administered solution and the amount of administered electrolytes;
• overload of the circulatory system with pulmonary edema (especially in patients with congestive heart failure or severe kidney failure).

Due to the potassium content in the medicine, the doctor will recommend monitoring the potassium concentration in the blood
in patients with a risk of hyperkalemia (elevated potassium levels) e.g. in patients with severe kidney failure.
Due to the calcium content and the risk of coagulation, the doctor will not recommend the use of RINGER'S SOLUTION FRESENIUS during blood transfusion through the same set.

RINGER'S SOLUTION FRESENIUS and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Do not use the following medicines concomitantly with RINGER'S SOLUTION FRESENIUS:

• digitalis glycosides (medicines used to treat heart failure) due to the risk of severe or life-threatening heart rhythm disorders (arrhythmias), especially if the patient has decreased potassium levels in the blood;
• potassium-sparing diuretics (amiloride, potassium canrenoate, spironolactone, triamterene) due to the risk of life-threatening hyperkalemia (elevated potassium levels in the blood), particularly in patients with kidney function disorders.

Particular caution should be exercised when using the following medicines concomitantly with RINGER'S SOLUTION FRESENIUS:

• thiazide diuretics (medicines that increase urine production, such as hydrochlorothiazide) due to the risk of increased calcium levels in the blood caused by decreased calcium excretion in the urine;
• angiotensin-converting enzyme inhibitors (medicines used to treat high blood pressure) due to the risk of life-threatening hyperkalemia, particularly in patients with kidney function disorders;
• tacrolimus (a medicine used to treat e.g. atopic dermatitis) due to the risk of life-threatening hyperkalemia, particularly in patients with kidney function disorders;
• corticosteroids (also known as steroids, medicines used to treat e.g. rheumatic disease);
• corticotropin (a hormone of the pituitary gland).

Due to the calcium content, RINGER'S SOLUTION FRESENIUS should not be mixed with solutions containing carbonates, oxalates, or phosphates.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
RINGER'S SOLUTION FRESENIUS may be administered during pregnancy and breast-feeding only if the doctor considers it necessary. Monitoring of water-electrolyte balance is necessary.

Driving and using machines

No data available.

3. How to use RINGER'S SOLUTION FRESENIUS

This medicine is administered only by medical personnel. The medicine must not be used by itself.
In case of doubts, consult a doctor.
Dosage is determined by the doctor individually for each patient, depending on the clinical condition,
age, body weight, and laboratory test results. Detailed information is contained in the section:
Information intended exclusively for healthcare professionals.

Use of a higher than recommended dose of RINGER'S SOLUTION FRESENIUS

In case of use of a higher dose of the medicine, inform the doctor or nurse immediately.
Use of a higher dose of the medicine may cause:

• overhydration (excess fluid in the body);
• overload with substances dissolved in RINGER'S SOLUTION FRESENIUS.

In case of any further doubts related to the use of this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

• electrolyte disturbances.

Common (may affect up to 1 in 10 people):

• overhydration;
• heart failure in patients with heart function disorders or pulmonary edema.

Frequency not known (cannot be estimated from the available data):

• edema caused by overhydration or sodium overload;
• when using large amounts of the medicine, dilution of blood components may occur, e.g. coagulation factors and other plasma proteins, as well as a decrease in hematocrit (a parameter evaluated in a blood test).

The following side effects may occur related to the administration technique:

• increased body temperature;
• infection at the injection site;
• phlebitis (formation of inflammation and small blood clots, manifested by palpable hardening of the vein, redness around it, pain, and tenderness);
• phlebitis spreading from the injection site;
• extravasation (leakage of the medicine outside the vein);
• hypervolemia (excessive blood volume in the blood vessels).

In case of side effects, the doctor will immediately stop the infusion, assess the patient's condition, and apply appropriate treatment.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store RINGER'S SOLUTION FRESENIUS

Store the medicine out of the sight and reach of children.
Do not freeze.
Use only a clear solution.
Do not use this medicine if you notice contamination or color changes, or if the packaging is damaged.
Unused remainder of the medicine is not suitable for further use. Follow the principles of asepsis.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month. Labeling on the packaging: EXP - expiry date, Lot - batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What RINGER'S SOLUTION FRESENIUS contains

The active substances of the medicine are: sodium chloride, potassium chloride, calcium chloride dihydrate .
1000 ml of the solution contains:
Sodium chloride (Natrii chloridum)
Potassium chloride (Kalii chloridum)
Calcium chloride dihydrate (Calcii chloridum dihydricum)
8.6 g
0.3 g
0.33 g
Ions:
Na
K
Ca
147.2 mmol/1000 ml
4.0 mmol/1000 ml
2.25 mmol/1000 ml
155.7 mmol/1000 ml
Cl
The other ingredients (excipients) are: water for injections, hydrochloric acid (for pH adjustment)
and sodium hydroxide (for pH adjustment).
The osmolality of the solution is 309 mOsmol/l, pH: 5.0 – 7.5.

What RINGER'S SOLUTION FRESENIUS looks like and contents of the pack

The medicine is a clear, colorless solution.
Packaging of the medicine:

• KabiPac polyethylene container with a cap - 100 ml, 250 ml, 500 ml, 1000 ml;
• KabiPac polyethylene container with a cap - 40 x 100 ml, 20 x 250 ml, 10 x 500 ml, 20 x 500 ml, 10 x 1000 ml, in a cardboard box;
• KabiClear polypropylene container with a cap - 100 ml, 250 ml, 500 ml, 1000 ml;
• KabiClear polypropylene container with a cap - 40 x 100 ml, 20 x 250 ml, 10 x 500 ml, 20 x 500 ml, 10 x 1000 ml, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Fresenius Kabi Polska Sp. z o.o.
ul. Sienkiewicza 25
99-300 Kutno
To obtain more detailed information, please contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

Date of last revision of the leaflet:

Information intended exclusively for healthcare professionals:

Dosage and administration

Dosage
The dosage is determined by the doctor depending on the patient's clinical condition, age, body weight, and laboratory test results. The daily dose depends on the patient's need for fluids and electrolytes.
Usually, the administered dose is 250 - 2800 ml of the solution in intravenous infusion per day,
at a maximum rate of 6 ml/min.
The infusion rate depends on the patient's clinical condition and is determined by the doctor.
Do not exceed the maximum daily dose of 40 ml/kg body weight.
Administration
Intravenous administration. Can be administered into peripheral veins.
Do not administer intramuscularly.

Overdose

Overdose or too high an administration rate may lead to overhydration and sodium overload, which carries the risk of peripheral edema, pulmonary edema, and cerebral edema. Electrolyte concentration and acid-base balance disorders may occur.
In case of overhydration or overload with substances dissolved in the medicine, immediately stop the infusion and assess the patient's clinical condition, and apply appropriate treatment to increase renal excretion through the use of fast-acting diuretics (e.g. furosemide).

Interactions with other medicines and other types of interactions

Interactions with calcium
Concomitant use with digitalis glycosides is contraindicated due to the risk of severe or life-threatening heart rhythm disorders (arrhythmias), especially if the patient has hypokalemia.
Particular caution should be exercised when using thiazide diuretics concomitantly due to the risk of hypercalcemia caused by decreased calcium excretion in the urine.
Interactions with potassium
Concomitant use with potassium-sparing diuretics (amiloride, potassium canrenoate, spironolactone, triamterene) is contraindicated due to the risk of life-threatening hyperkalemia, particularly in patients with kidney function disorders (additive hyperkalemic effect).
It is not recommended to combine RINGER'S SOLUTION FRESENIUS with:

• angiotensin-converting enzyme inhibitors due to the risk of life-threatening hyperkalemia, particularly in patients with kidney function disorders (additive hyperkalemic effect);
• tacrolimus due to the risk of life-threatening hyperkalemia, particularly in patients with kidney function disorders (additive hyperkalemic effect);
• corticosteroids and corticotropin.

Preparation of the medicine for use

Use only a clear solution.
Do not use this medicine if you notice contamination or color changes,
or if the packaging is damaged.
Unused remainder of the medicine is not suitable for further use.
Follow the principles of asepsis.
Instructions for use of KabiPac and KabiClear containers:

• 1. Before use, check the appearance of the container and the solution – the solution should be clear, without contamination (do not use damaged and/or previously used containers).
• 2. Preparation of the infusion: a) Place the KabiPac/KabiClear container on a stable and even surface. b) Remove the plastic cover/plug from the larger port (infusion port) with the arrow pointing outward. c) Insert the needle of the infusion set perpendicularly into the infusion port, gently rotating the set with your hand, while holding the neck of the container with your other hand.
• 3. Adding the medicine to the packaging: a) Place the KabiPac/KabiClear container on a stable and even surface. b) Remove the plastic cover/plug from the smaller port (injection port) with the arrow pointing inward, and then insert the needle into the center of the injection port and add the medicine to the KabiPac/KabiClear container.

Note: The ports are sterile, do not require disinfection before first use.

Medical devices intended for administration and addition of the medicine should be used in accordance with their instructions for use. The solution obtained after adding the medicine should be carefully mixed and checked to ensure that no precipitates have formed in the solution.

Incompatibilities

Due to the calcium content, RINGER'S SOLUTION FRESENIUS should not be mixed with solutions containing carbonates, oxalates, or phosphates.
Consider the potential possibility of incompatibility of medicines added to RINGER'S SOLUTION FRESENIUS, paying attention to possible color changes and/or formation of precipitates, insoluble complexes, or crystals. Also, consult the information about the medicine to be added.
Before adding another medicine, check if the pH range in which it is effective is the same as for RINGER'S SOLUTION FRESENIUS.
When adding other medicines to RINGER'S SOLUTION FRESENIUS, the mixture should be administered immediately.

Disposal of unused medicine

Any unused remainder of the medicine or its waste should be disposed of in accordance with local regulations.