Pvin Ringera z mlehanami Fresenius

Leaflet attached to the packaging: information for the user

RINGER'S SOLUTION WITH LACTATE FRESENIUS, solution for infusion

Complex product

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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

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

RINGER'S SOLUTION WITH LACTATE FRESENIUS is an aqueous solution of mineral salts (sodium, potassium, calcium) and salts of organic acids (sodium lactate) used to fill the vascular bed and restore the water-electrolyte balance of the body. The composition of the medicine is very similar to the composition of the extracellular fluid in the body. The medicine is administered intravenously.

Indications for use:

• dehydration regardless of the cause (vomiting, diarrhea, fistulas, etc.);
• hypovolemia (too small a volume of blood 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 WITH LACTATE 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 WITH LACTATE FRESENIUS

FRESENIUS

When not to use RINGER'S SOLUTION WITH LACTATE FRESENIUS

Do not use RINGER'S SOLUTION WITH LACTATE FRESENIUS:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has an excess of fluid in the body (is overhydrated);
• in the treatment of lactic acidosis (accumulation of lactic acid in the body).

The use of the medicine may be contraindicated:

• if the patient has congestive heart failure (disorders of heart function manifesting as swelling in the legs, pulmonary edema);
• if the patient has too high a concentration of sodium, chloride, potassium or calcium in the blood;
• in situations where the patient should limit sodium intake (e.g. due to severe renal failure, pulmonary edema);
• concomitantly with digitalis glycosides and potassium-sparing diuretics (see section "RINGER'S SOLUTION WITH LACTATE FRESENIUS and other medicines");
• if the patient has liver failure;
• if the patient has too high a concentration of lactate in the blood.

Warnings and precautions

During the administration of RINGER'S SOLUTION WITH LACTATE FRESENIUS, the doctor will monitor the patient's condition and order blood tests (to check for fluid balance disorders, electrolyte concentration and acid-base balance), especially if the patient:

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

RINGER'S SOLUTION WITH LACTATE 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 renal failure);
• metabolic alkalosis due to the presence of lactate ions;
• disorders of lactate ion utilization in patients with liver function disorders, and especially with liver failure, in whom the concentration of lactate ions is increased.

Before starting treatment with RINGER'S SOLUTION WITH LACTATE FRESENIUS, the patient should inform their doctor or nurse if:

• the patient has heart failure;
• the patient has respiratory failure;
• the patient has a condition that may cause increased vasopressin levels (a hormone that regulates water content in the body). In the above cases, the medicine should be administered under special supervision.

Increased vasopressin levels in the body may occur:

• if the patient has had a sudden or severe illness;
• if the patient is experiencing severe pain;
• if the patient has undergone surgery;
• if the patient has an infection, burn or central nervous system disease;
• if the patient has heart, liver or kidney disease;
• if the patient is taking certain medications. This may increase the risk of low sodium levels in the blood, which can lead to symptoms such as headache, nausea, seizures, lethargy, coma, brain edema and death. Brain edema increases the risk of death and brain damage. The increased risk of brain edema occurs in:
• children;
• women (especially of childbearing age);
• patients with disorders of cerebrospinal fluid volume, which may be caused by meningitis, intracranial hemorrhage or brain damage.

Patients should be closely monitored. In cases where normal regulation of water content in the blood is disturbed due to increased secretion of antidiuretic hormone (ADH), infusion of low-sodium fluids (hypotonic fluids) may lead to low sodium levels in the blood (hyponatremia). This can cause symptoms such as headache, nausea, seizures, drowsiness, coma, brain edema and death, so the occurrence of these symptoms (severe symptomatic encephalopathy with hyponatremia) is considered a life-threatening condition.

The doctor will recommend monitoring the potassium level in the blood in patients at risk of hyperkalemia (elevated potassium levels) e.g. in severe renal failure due to the potassium content in the medicine.

The doctor will not recommend using RINGER'S SOLUTION WITH LACTATE FRESENIUS during blood transfusion through the same set due to the calcium content and the risk of coagulation.

RINGER'S SOLUTION WITH LACTATE FRESENIUS and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or plan to take.

Do not use the following medicines concomitantly with RINGER'S SOLUTION WITH LACTATE 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 low 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), especially in patients with renal function disorders.

Particular caution should be exercised when using the following medicines concomitantly with RINGER'S SOLUTION WITH LACTATE 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, especially in patients with renal function disorders;
• tacrolimus (a medicine used to treat e.g. atopic dermatitis) due to the risk of life-threatening hyperkalemia, especially in patients with renal function disorders;
• corticosteroids (also known as steroids, medicines used to treat e.g. rheumatic disease);
• corticotropin (a hormone of the pituitary gland).

It is especially important to inform the doctor if the patient is taking any medicines that affect the action of vasopressin, including:

• antidiabetic medicines (chlorpropamide);
• cholesterol-lowering medicines (clofibrate);
• antiepileptic medicines (carbamazepine);
• medicines with a chemical structure similar to amphetamine (including MDMA);
• certain anticancer medicines (vincristine, ifosfamide, cyclophosphamide);
• selective serotonin reuptake inhibitors (used to treat depression);
• antipsychotic medicines;
• opioids used to treat severe pain;
• analgesic and/or anti-inflammatory medicines (also known as nonsteroidal anti-inflammatory drugs, NSAIDs);
• medicines that mimic or enhance the action of vasopressin, such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat bleeding from the esophagus) and oxytocin (used to induce labor);
• other medicines that increase the risk of hyponatremia, including all diuretics and antiepileptic medicines such as oxcarbazepine.

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

RINGER'S SOLUTION WITH LACTATE FRESENIUS may be administered during pregnancy and breastfeeding only if the doctor considers it necessary. Monitoring of water-electrolyte balance is necessary.

Particular caution should be exercised when administering this medicine to pregnant women during labor, especially in combination with oxytocin (a hormone used to induce labor and limit bleeding) due to the risk of hyponatremia.

Driving and using machines

No data available.

3. How to use RINGER'S SOLUTION WITH LACTATE FRESENIUS

This medicine is administered only by medical personnel. The medicine should not be used by itself.

In case of doubts, consult a doctor.

The 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 only for healthcare professionals.

The doctor will monitor the amount of fluid in the body, blood acidity, urine flow and electrolyte concentration (especially sodium) in the blood (mainly in patients with high vasopressin levels or patients taking other medicines that enhance the action of vasopressin), at the beginning of the infusion (drip) and during its administration.

Administration of a higher dose of RINGER'S SOLUTION WITH LACTATE FRESENIUS than recommended

FRESENIUS

In case of administration of a higher dose of the medicine, the doctor or nurse should be informed immediately.

Administration of a higher dose of the medicine than recommended may cause:

• overhydration (excess fluid in the body);
• overload with substances dissolved in RINGER'S SOLUTION WITH LACTATE 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):

• allergic reactions, sometimes severe, such as local or generalized urticaria, rash and flushing, itching, skin edema, facial edema and/or laryngeal edema (Quincke's edema);
• electrolyte disorders;
• respiratory symptoms: feeling of nasal congestion, cough, sneezing, bronchospasm and/or difficulty breathing.

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

• feeling of restlessness;
• heart failure in patients with heart function disorders or pulmonary edema;
• chest tightness;
• chest pain with rapid heart rate (tachycardia) or slow heart rate (bradycardia);
• itching;
• overhydration.

Uncommon (may affect up to 1 in 100 people):

• seizures (caused by alkalosis).

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);
• low sodium levels in the blood (hyponatremia) that can lead to brain damage and death due to brain edema (see section "Warnings and precautions").

A few cases of panic have been reported.

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

• increased body temperature;
• infection at the injection site;
• phlebitis (inflammation of the vein, manifesting as a palpable hardening of the vein, redness around it, pain and tenderness);
• spread of inflammation 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 side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 WITH LACTATE FRESENIUS

The medicine should be stored out of sight and reach of children.

Do not freeze.

Use only a clear solution.

Do not use this medicine if you notice any contamination or color change, or if the packaging is damaged.

Unused medicine should not be used. Follow aseptic procedures.

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. The packaging is labeled with: 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 packaging and other information

What RINGER'S SOLUTION WITH LACTATE FRESENIUS contains

The active substances of the medicine are: sodium chloride, potassium chloride, calcium chloride dihydrate, sodium lactate.

1000 ml of the solution contains:

Sodium chloride (Natrii chloridum)

6.00 g

Potassium chloride (Kalii chloridum)

0.40 g

Calcium chloride dihydrate (Calcii chloridum dihydricum)

0.27 g

Sodium lactate (Natrii lactate)

6.34 g

Ions:

Na

131.0 mmol/1000 ml

5.36 mmol/1000 ml

K

Ca

1.84 mmol/1000 ml

C H O

Cl

28.3 mmol/1000 ml

112.0 mmol/1000 ml

The other ingredients (excipients) are: water for injections, hydrochloric acid (to adjust pH) and sodium hydroxide (to adjust pH).

The osmolality of the solution is 278.5 mOsmol/l, pH: 5.0 - 7.0.

What RINGER'S SOLUTION WITH LACTATE FRESENIUS looks like and what the packaging contains

The medicine is a clear and transparent liquid.

Packaging of the medicine:

• KabiPac polyethylene container with cap - 100 ml, 250 ml, 500 ml, 1000 ml;
• KabiPac polyethylene container 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;
• KabiClear polypropylene container with cap - 100 ml, 250 ml, 500 ml, 1000 ml;
• KabiClear polypropylene container 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 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, 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 only 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, a dose of 2.5 ml/kg body weight/hour should be administered by intravenous infusion.

The maximum daily dose should not exceed 40 ml/kg body weight.

The maximum daily dose depends on the patient's need for fluids and electrolytes.

The maximum infusion rate depends on the patient's clinical condition and is determined by the doctor.

Administration

Intravenous administration. Can be administered into peripheral veins.

Do not administer intramuscularly.

Due to the risk of hospital-acquired hyponatremia, before and during administration of the medicine, it may be necessary to monitor electrolyte concentrations in serum and acid-base balance, as well as pay special attention to sodium levels in serum in patients with non-osmotic stimulation of vasopressin secretion (syndrome of inappropriate antidiuretic hormone secretion - SIADH) and in patients receiving concomitantly vasopressin agonist drugs.

Monitoring of sodium levels in serum is especially important during administration of hypotonic fluids relative to physiological osmotic pressure.

The rate and volume of infusion depend on the patient's age, body weight and clinical condition (e.g. burns, surgery, head injuries, infections), so in children, concomitant treatment should be determined by a doctor specializing in intravenous fluid therapy in children.

Overdose

Overdose or too rapid administration may lead to overhydration and sodium overload, which carries the risk of peripheral edema, pulmonary edema and brain edema. Electrolyte and acid-base balance disorders may occur.

Administration of too much potassium may lead to the development of hyperkalemia, especially in patients with renal function disorders. Symptoms include: paresthesia in the limbs, muscle weakness, paralysis, heart rhythm disorders, heart block, cardiac arrest, confusion.

Administration of too much calcium may lead to hypercalcemia. Symptoms of hypercalcemia include: anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disorders, excessive thirst, polyuria, kidney stones and, in severe cases, heart rhythm disorders and coma. Too rapid intravenous infusion of calcium may cause many symptoms of hypercalcemia, as well as a chalky taste in the mouth, hot flashes and peripheral vasodilation. Mild, asymptomatic hypercalcemia usually resolves after discontinuation of calcium and other similarly acting medicines, such as vitamin D. In case of acute hypercalcemia, immediate treatment is necessary (e.g. loop diuretics, hemodialysis, calcitonin, bisphosphonates, sodium edetate).

Administration of too much lactate may lead to metabolic alkalosis. Metabolic alkalosis may be accompanied by hypokalemia. Symptoms may include: mood changes, fatigue, shortness of breath, muscle weakness and irregular heart rhythm. Increased muscle tone, tremors and tetany may worsen, especially in patients with hypocalcemia. Treatment of metabolic alkalosis caused by lactate overdose consists mainly of restoring water-electrolyte balance. Particular attention should be paid to supplementing calcium, chloride and potassium deficiencies.

If the overdose concerns medicines added to the solution administered by infusion, the subjective and objective symptoms of overdose will depend on the properties of the added component.

In case of accidental administration of too large a volume of the solution, the infusion should be stopped and the patient should be monitored for symptoms of overdose of the administered medicine. If necessary, appropriate symptomatic and supportive treatment should be applied.

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 low potassium levels in the blood.

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, especially in patients with renal function disorders (additive hyperkalemic effect).

The following medicines should not be used concomitantly with RINGER'S SOLUTION WITH LACTATE FRESENIUS:

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

Medicines that enhance the action of vasopressin

The following medicines enhance the action of vasopressin, leading to decreased renal excretion of water without electrolytes and may increase the risk of hospital-acquired hyponatremia after inadequately balanced fluid therapy:

• medicines that stimulate the release of vasopressin, e.g. chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotic medicines, opioids;
• medicines that enhance the action of vasopressin, e.g. chlorpropamide, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclophosphamide;
• vasopressin analogues, e.g. desmopressin, oxytocin, vasopressin, terlipressin.

Other medicines that increase the risk of hyponatremia include all diuretics and antiepileptic medicines, such as oxcarbazepine.

Preparation of the medicine for use

Use only a clear solution.

Do not use this medicine if you notice any contamination or color change, or if the packaging is damaged.

Unused medicine should not be used. Follow aseptic procedures.

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/cap from the larger port (infusion port) with the arrow pointing outward from the packaging. c) Insert the needle 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 medicine to the packaging: a) Place the KabiPac/KabiClear container on a stable and even surface. b) Remove the plastic cover/cap from the smaller port (injection port) with the arrow pointing inward from the packaging, 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, no disinfection is required 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 resulting from the addition of the medicine should be carefully mixed and checked for precipitation or sediment.

Incompatibilities

RINGER'S SOLUTION WITH LACTATE FRESENIUS contains calcium ions and should not be administered during blood transfusion through the same set due to the risk of coagulation.

Potential incompatibilities of medicines added to RINGER'S SOLUTION WITH LACTATE FRESENIUS should be considered, paying attention to possible color changes and/or formation of precipitates, insoluble complexes or crystals. Information about the medicine to be added should also be consulted.

For example, RINGER'S SOLUTION WITH LACTATE FRESENIUS is incompatible with medicines containing carbonates, oxalates, phosphates, aminocaproic acid, amphotericin B, mafenide, cefamandole, hydrocortisone acetate, diethylstilbestrol, erythromycin, etomidate, ethanol, oxytetracycline, sodium thiopental, disodium edetate.

In addition, partial incompatibilities with RINGER'S SOLUTION WITH LACTATE FRESENIUS have been reported for the following medicines:

• tetracycline - stable for 12 hours;
• sodium ampicyllin:
• at a concentration of 2% to 3% stable for 4 hours;
• at a concentration >3% should be administered within 1 hour;
• minocycline - stable for 12 hours;
• doxycycline - stable for 6 hours.

The above list of substances is not exhaustive.

Before adding another medicine, check if the pH range in which it is effective is the same as for RINGER'S SOLUTION WITH LACTATE FRESENIUS.

When adding other medicines to RINGER'S SOLUTION WITH LACTATE FRESENIUS, the mixture should be administered immediately.

Disposal of unused medicine

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