Ringer's solution fresenius

Package leaflet: Information for the user

RINGERS SOLUTION FRESENIUS, (8.6 mg + 0.3 mg + 0.33 mg)/ml, infusion solution
Sodium chloride + Potassium chloride + Calcium chloride dihydrate
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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

1. What RINGERS SOLUTION FRESENIUS is and what it is used for

RINGERS SOLUTION FRESENIUS is an aqueous solution of mineral salts (sodium, potassium, calcium) used to replenish intravascular volume and restore the body's fluid and electrolyte balance. The composition of the solution closely resembles that of extracellular fluid in the body. The solution is administered intravenously.

Indications:

• Dehydration of any cause (e.g. vomiting, diarrhoea, fistula losses, etc.);
• Hypovolaemia (reduced blood volume in the circulatory system) due to:
  • Burns;
  • Loss of water and/or electrolytes following surgical procedures;
  • Haemorrhagic shock – for initial restoration of intravascular volume.

RINGERS SOLUTION FRESENIUS may be used for diluting and dissolving electrolyte concentrates and medicinal products that are compatible.

2. Important information before using the medicinal product PŁYN RINGERA FRESENIUS

When not to use PŁYN RINGERA FRESENIUS
PŁYN RINGERA FRESENIUS must not be used:

• if the patient is allergic to the active substances or to any of the other components of this medicinal product (listed in section 6);
• if the patient has excess body fluid (is overhydrated).

Use of this medicinal product may be contraindicated:

• if the patient has congestive heart failure (heart dysfunction manifested, among others, by ankle swelling, pulmonary edema);
• if the patient has too high blood levels of sodium, chloride, potassium, or calcium;
• in situations when the patient should restrict sodium intake (e.g. due to severe renal failure, pulmonary edema);
• concomitantly with cardiac glycosides and potassium-sparing diuretics (see section: PŁYN RINGERA FRESENIUS and other medicinal products).

Warnings and precautions
During administration of PŁYN RINGERA FRESENIUS, the physician will monitor the patient's condition and order blood tests (to check for disturbances in fluid balance, electrolyte concentrations, and acid-base balance), especially if the patient:

• has congestive heart failure;
• has severe renal failure;
• has edema caused by sodium retention;
• is being treated with corticosteroids and their derivatives (see section: PŁYN RINGERA FRESENIUS and other medicinal products).

PŁYN RINGERA FRESENIUS will be administered with caution due to the risk of:

• complications related to the volume of infused solution and the amount of electrolytes administered;
• circulatory overload with pulmonary edema (particularly in patients with congestive heart failure or severe renal failure).

Due to the potassium content of this medicinal product, the physician will recommend monitoring blood potassium levels in patients at risk of hyperkalemia (elevated potassium levels), e.g. in patients with severe renal failure.
Due to the calcium content and the risk of precipitation, the physician will not recommend using PŁYN RINGERA FRESENIUS during blood transfusion through the same set.

PŁYN RINGERA FRESENIUS and other medicinal products
Inform the physician or pharmacist about all medicinal products currently or recently used, as well as any medicinal products the patient plans to use.
Do not use the following medicinal products concomitantly with PŁYN RINGERA FRESENIUS:

• cardiac glycosides (medicinal products used in the treatment of heart failure) due to the risk of severe or life-threatening cardiac rhythm disturbances (arrhythmias), especially if the patient has low blood potassium levels;
• potassium-sparing diuretics (amiloride, potassium canrenoate, spironolactone, triamterene) due to the risk of life-threatening hyperkalemia (elevated blood potassium levels), particularly in patients with renal function disorders.

Exercise particular caution when using the following medicinal products concomitantly with PŁYN RINGERA FRESENIUS:

• thiazide diuretics (medicinal products increasing urine production, such as hydrochlorothiazide) due to the risk of increased blood calcium levels caused by reduced calcium excretion in urine;
• angiotensin-converting enzyme (ACE) inhibitors (medicinal products used in the treatment of arterial hypertension) due to the risk of life-threatening hyperkalemia, particularly in patients with renal function disorders;
• tacrolimus (a medicinal product used, among others, in the treatment of atopic dermatitis) due to the risk of life-threatening hyperkalemia, particularly in patients with renal function disorders;
• corticosteroids (also known as steroids, medicinal products used, among others, in the treatment of rheumatic diseases);
• corticotropin (a pituitary hormone).

Due to the calcium content, PŁYN RINGERA FRESENIUS must not be mixed with solutions containing carbonates, oxalates, or phosphates.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a physician or pharmacist before using this medicinal product.
PŁYN RINGERA FRESENIUS may be administered during pregnancy and breastfeeding only if the physician considers it necessary. Monitoring of fluid and electrolyte balance is required in such cases.

Driving and operating machinery
No data available.

3. How to use PŁYN RINGERA FRESENIUS

This medicine is administered exclusively by medical personnel.
You must not use this medicine yourself.
If in doubt, consult your doctor.
The dosage is determined individually for each patient by the doctor, depending on clinical condition,
age, body weight, and laboratory test results. Detailed information is provided in the section:
Information intended exclusively for healthcare professionals.
Administration of a higher than recommended dose of PŁYN RINGERA FRESENIUS
If a higher dose of the medicine is administered, inform the doctor or nurse immediately.
Administration of a higher than recommended dose may cause:

• fluid overload (excess fluid in the body);
• overload with substances dissolved in PŁYN RINGERA FRESENIUS.

If you have any further doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Very common (may affect more than 1 in 10 people):

• electrolyte disturbances.

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

• fluid overload;
• heart failure in patients with impaired cardiac function or pulmonary edema.

Frequency unknown (cannot be estimated from available data):

• edema caused by fluid overload or sodium overload;
• when large amounts of the medicine are administered, dilution of blood components may occur, e.g. clotting factors and other plasma proteins, as well as decreased hematocrit (a parameter assessed in blood tests).

The following adverse symptoms related to the administration technique may occur:

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

If adverse reactions occur, the physician will immediately discontinue the infusion, assess the patient's condition, and initiate appropriate treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store RINGER FRESINIUS SOLUTION

Keep the medicine out of sight and reach of children.
Do not freeze.
Use only a clear, transparent solution.
Do not use this medicine if you notice any particles, discoloration, or if the packaging is damaged.
Any unused portion of the medicine must not be used later. Follow aseptic techniques.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. The labelling on the packaging reads: EXP – expiry date, Lot – batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

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

What PŁYN RINGERA FRESENIUS looks like and contents of the pack
The medicinal product is a clear, colourless solution.
Packaging:

• Polyethylene container KabiPac with cap – 100 ml, 250 ml, 500 ml, 1000 ml;
• Polyethylene container KabiPac with 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;
• Polypropylene container KabiClear with cap – 100 ml, 250 ml, 500 ml, 1000 ml;
• Polypropylene container KabiClear with 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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

For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

Information intended exclusively for medical professionals:

Dosage and administration
Dosage
The dosage is determined by the physician according to the patient's clinical condition, age, body weight, and laboratory test results. The daily dose depends on the patient's requirements for fluids and electrolytes.
The usual administered dose is 250–2800 ml of the solution administered as an intravenous infusion over 24 hours, at a maximum rate of 6 ml/min.
The infusion rate depends on the patient's clinical condition and is determined by the physician.
The maximum daily dose of 40 ml/kg body weight must not be exceeded.

Route of administration
Intravenous administration. May be administered via peripheral veins.
Do not administer intramuscularly.

Overdose
Overdose or too rapid administration may lead to fluid overload and sodium overload, resulting in risk of peripheral, pulmonary, or cerebral edema. Electrolyte imbalances and disturbances in acid-base equilibrium may occur.
In case of fluid overload or solute overload, the infusion must be immediately discontinued, the patient's clinical condition assessed, and appropriate treatment initiated to enhance renal excretion, using fast-acting diuretics (e.g., furosemide).

Interactions with other medicinal products and other forms of interactions
Calcium interactions
Concomitant use with cardiac glycosides (digitalis) is contraindicated due to the risk of severe or life-threatening cardiac arrhythmias, especially in patients with hypokalemia.
Particular caution is required when using thiazide diuretics concomitantly, due to the risk of hypercalcemia caused by reduced urinary calcium excretion.

Potassium interactions
Concomitant use with potassium-sparing diuretics (amiloride, potassium canrenoate, spironolactone, triamterene), used either as monotherapy or in combination, is contraindicated due to the risk of life-threatening hyperkalemia, particularly in patients with impaired renal function (additive hyperkalemic effect).
Concomitant use of PŁYN RINGERA FRESENIUS with the following is not recommended:

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

Preparation of the medicinal product for administration
Use only clear solution.
Do not use this medicinal product if contamination or discoloration is observed, or if the container is damaged.
Any unused portion of the medicinal product must not be retained for later use.
Follow aseptic procedures.

Instructions for use of KabiPac and KabiClear container types:

1. Before use, inspect the container and solution visually – the solution should be clear and free from particulate matter (do not use damaged and/or previously used containers).
2. Preparing the infusion:
   a) Place the KabiPac/KabiClear container on a stable, flat surface.
   b) Remove the plastic cover/plug from the larger port (infusion port) with the arrow pointing outward from the container.
   c) Insert the spike of the infusion set vertically into the infusion port, gently rotating the set with one hand while holding the neck of the container with the other hand.
3. Adding medicinal product to the container:
   a) Place the KabiPac/KabiClear container on a stable, flat surface.
   b) Remove the plastic cover/plug from the smaller port (injection port) with the arrow pointing inward toward the container, then insert the needle into the center of the injection port and add the medicinal product to the KabiPac/KabiClear container.

Note: Ports are sterile and do not require disinfection before first use.
Medical devices intended for administration and addition of medicinal products must be used in accordance with their instructions for use. The solution resulting from the addition of a medicinal product should be thoroughly mixed, and it must be ensured that no precipitate has formed.

Pharmaceutical incompatibilities
Due to its calcium content, PŁYN RINGERA FRESENIUS must not be mixed with solutions containing carbonates, oxalates, or phosphates.
Potential incompatibilities with other medicinal products added to PŁYN RINGERA FRESENIUS must be considered, paying attention to possible changes in color and/or formation of precipitates, insoluble complexes, or crystals. The product information of the medicinal product to be added should be consulted.
Before adding another medicinal product, verify whether its effective pH range is compatible with that of PŁYN RINGERA FRESENIUS.
When other medicinal products are added to PŁYN RINGERA FRESENIUS, the mixture should be administered immediately.

Disposal of unused medicinal product or waste
Any unused residues of the medicinal product or waste materials must be disposed of in accordance with local regulations.