Ringer Lactate

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Ringer Lactate, solution for infusion

Active substances: sodium chloride, potassium chloride, calcium chloride dihydrate, and sodium lactate

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 or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, inform the doctor or nurse. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS RINGER LACTATE AND WHAT IS IT USED FOR

Ringer Lactate is an aqueous solution containing the following substances:

• sodium chloride;
• potassium chloride;
• calcium chloride dihydrate;
• sodium lactate. Sodium, potassium, calcium, chloride, and lactate are chemical substances (electrolytes) found in the blood.

Ringer Lactate is used:

• to treat fluid and chemical loss (e.g., due to excessive sweating, kidney disorders);
• in cases of low blood volume (hypovolemia) or low blood pressure (hypotension);
• in metabolic acidosis (when the blood becomes too acidic).

2. IMPORTANT INFORMATION BEFORE USING RINGER LACTATE

RINGER LACTATE SHOULD NOT BE USED IF THE PATIENT HAS ANY OF THE FOLLOWING CONDITIONS:

• newborn (under 28 days) receiving ceftriaxone (an antibiotic);
• allergy to sodium lactate or any other component of Ringer Lactate (listed in section 6);
• excessive fluid accumulation in the tissues (hyperhydration);
• higher than normal blood volume (hypervolemia);
• severe kidney failure (when kidney function is impaired and the patient requires dialysis);
• uncontrolled heart failure. This is heart failure that is not properly treated and causes symptoms such as:
• shortness of breath;
• swelling around the ankles.
• high potassium levels in the blood (hyperkalemia);
• high calcium levels in the blood (hypercalcemia);
• metabolic alkalosis (a condition where the blood becomes too alkaline);
• liver disease causing fluid accumulation in the abdominal cavity (liver cirrhosis with ascites);
• severe metabolic acidosis (a life-threatening condition);
• a certain type of metabolic acidosis (lactic acidosis);
• severe liver disease (when liver function is impaired and requires intensive treatment);
• impaired lactate metabolism (occurring in severe liver disease, as lactate is removed from the body by the liver);
• in cases of using cardiac glycosides (cardiotonic drugs), such as digitalis or digoxin, used to treat heart failure (see also "RINGER LACTATE SHOULD NOT BE USED IF THE PATIENT HAS..."). The action of these drugs may be enhanced by calcium, which can lead to life-threatening changes in heart rhythm.

WARNINGS AND PRECAUTIONS

Before starting Ringer Lactate, consult a doctor or nurse if the patient currently has or has had any of the following situations or clinical conditions:

• receiving ceftriaxone (an antibiotic) (see also "OTHER MEDICINES AND RINGER LACTATE");
• heart failure;
• respiratory failure (lung disease) (in the above cases, the patient may require special monitoring);
• impaired kidney function;
• higher than normal chloride levels in the blood (hyperchloremia);
• high blood pressure (hypertension);
• fluid accumulation under the skin, affecting all parts of the body (generalized edema);
• fluid accumulation under the skin, especially around the ankles (peripheral edema);
• fluid accumulation in the lungs (pulmonary edema);
• high blood pressure during pregnancy (pre-eclampsia);
• a disease causing high levels of a hormone called aldosterone (aldosteronism);
• higher than normal sodium levels in the blood (hypernatremia) or any other conditions related to sodium retention (when the body retains too much sodium) such as steroid treatment (see also "OTHER MEDICINES AND RINGER LACTATE");
• any heart diseases;
• any conditions where the patient has an increased risk of high potassium levels in the blood (hyperkalemia), such as:
• kidney failure;
• adrenal gland failure (a disease of the adrenal gland that affects hormone levels);
• severe dehydration (fluid loss from the body, e.g., due to vomiting or diarrhea);
• extensive tissue damage (e.g., after severe burns). It is necessary to closely monitor potassium levels in the blood.
• diseases related to high levels of vitamin D (e.g., sarcoidosis, skin and internal organ disease);
• kidney stones;
• impaired liver function;
• diabetes;
• a condition that may cause high levels of vasopressin, a hormone that regulates fluid in the body. Excessive vasopressin levels in the body can be caused by, for example:
• -sudden and severe illness;
• -pain;
• -surgery;
• -infection, burns, or brain disease;
• -diseases related to the heart, liver, kidneys, or central nervous system;
• -taking certain medications (see also "OTHER MEDICINES AND RINGER LACTATE"); This may increase the risk of low sodium levels in the blood and cause symptoms such as headache, nausea, seizures, drowsiness, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. Patients at higher risk of brain swelling are:
• -children
• -women (especially of childbearing age)
• patients with problems with cerebrospinal fluid levels, such as due to meningitis, intracranial hemorrhage, or brain damage.

The patient receiving Ringer Lactate infusion will undergo blood and urine tests, and the doctor will also monitor:

• fluid levels in the body;
• blood and urine acidity (acid-base balance);
• electrolyte levels in the blood (especially sodium and potassium).

Although Ringer Lactate contains potassium, its amount is not sufficient to treat very low potassium levels in the blood (severe hypokalemia).
Calcium chloride can be harmful if injected into body tissues. Therefore, Ringer Lactate should not be injected into muscles (intramuscular injection). Additionally, the doctor will take all necessary precautions to avoid the solution leaking into the tissues surrounding the vein.
Ringer Lactate should not be administered through the same needle used for blood transfusion. This may cause damage to red blood cells or their clumping.
Since Ringer Lactate contains lactate (a substance found in the body), it may cause excessive alkalinity of the blood (metabolic alkalosis).
Particular caution should be exercised when administering Ringer Lactate to children under 6 months of age.
The doctor will consider whether the patient is receiving parenteral nutrition (nutrition administered through an intravenous infusion). If Ringer Lactate is administered for a long time, the patient will receive nutrients from an additional source.

OTHER MEDICINES AND RINGER LACTATE

Tell the doctor or nurse about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important to inform the doctor about the use of:

• ceftriaxone (an antibiotic), which should not be administered through the same infusion line without thorough flushing of the line;
• cardiac glycosides (cardiotonic drugs), such as digitalis or digoxin, used to treat heart failure; these should not be used in combination with Ringer Lactate (see also "RINGER LACTATE SHOULD NOT BE USED IF THE PATIENT HAS..."). The action of these drugs may be enhanced by calcium, which can lead to life-threatening changes in heart rhythm.
• corticosteroids (anti-inflammatory drugs). These drugs may cause sodium and water retention in the body, leading to:
• swelling of tissues due to fluid accumulation under the skin (edema);
• high blood pressure (hypertension).

The following medicines may increase potassium levels in the blood. This effect may be life-threatening, especially in patients with kidney disease.

• potassium-sparing diuretics (certain diuretics, e.g., amiloride, spironolactone, triamterene) (Note that these drugs may be part of combination products);
• angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure);
• angiotensin II receptor antagonists (used to treat high blood pressure);
• tacrolimus (used to prevent transplant rejection and treat certain skin diseases);
• cyclosporine (used to prevent transplant rejection).

Certain medicines may affect vasopressin levels. These include:

• -antidiabetic drugs (chlorpropamide)
• -cholesterol-lowering drugs (clofibrate)
• -certain anticancer drugs (vincristine, ifosfamide, cyclophosphamide)
• -selective serotonin reuptake inhibitors (used to treat depression)
• -antipsychotic drugs
• -opioids used to relieve severe pain
• -pain relievers and (or) anti-inflammatory drugs (also known as NSAIDs)
• -drugs that mimic or enhance the action of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat bleeding from the esophagus), and oxytocin (used to induce labor)
• -antiepileptic drugs (carbamazepine and oxcarbazepine)
• -diuretics (diuretics).

Other medicines that may interact with Ringer Lactate or be affected by it include:

• thiazide diuretics, such as hydrochlorothiazide or chlorthalidone;
• vitamin D;
• bisphosphonates (used to treat bone diseases, e.g., osteoporosis);
• fluoride (used to strengthen teeth and bones);
• fluoroquinolones (a type of antibiotic, including ciprofloxacin, norfloxacin, ofloxacin);
• tetracyclines (a type of antibiotic, including tetracycline);
• acidic drugs, including:
• salicylates used to treat inflammatory conditions (aspirin);
• barbiturates (sleeping pills);
• lithium (used to treat mental illnesses).
• alkaline drugs, including:
• sympathomimetics (stimulating drugs such as ephedrine and pseudoephedrine, ingredients in cough and cold preparations);
• other stimulating drugs (e.g., dexamphetamine, fenfluramine).

USING RINGER LACTATE WITH FOOD AND DRINK

Ask the doctor what the patient can eat or drink.

PREGNANCY, BREASTFEEDING, AND FERTILITY

In pregnancy, breastfeeding, or if the patient is pregnant or plans to become pregnant, consult a doctor or nurse before using this medicine.
Ringer Lactate can be safely used during pregnancy or breastfeeding.
The doctor will monitor electrolyte levels in the blood and fluid levels in the body.
Calcium may pass into the unborn baby's body through the placenta and, after birth, through breast milk.
If it is necessary to add another medicine to the infusion solution during pregnancy or breastfeeding, the patient should:

• consult a doctor;
• read the leaflet included with the added medicine.

DRIVING AND USING MACHINES

Ask the doctor or pharmacist for advice before driving or using machines.

3. HOW TO USE RINGER LACTATE

Ringer Lactate is administered by a doctor or nurse. The doctor will decide what dose to use and when to administer the medicine. This depends on the patient's age, weight, condition, and reason for treatment.
The amount of medicine administered may also depend on other medicines the patient is taking.
DO NOT USE RINGER LACTATE IF THE SOLUTION CONTAINS VISIBLE PARTICLES OR IF THE PACKAGE IS DAMAGED IN ANY WAY.
Ringer Lactate infusion solution is usually administered through a plastic tube connected to a needle inserted into a vein. Typically, the solution is administered through a vein in the arm. However, the doctor may use a different method to administer the medicine to the patient.
Before and during infusion, the doctor will monitor:

• fluid levels in the body;
• blood and urine acidity;
• electrolyte levels in the body (especially sodium and potassium, in patients with high vasopressin levels or taking other medicines that increase the effect of vasopressin).

Discard any unused solution. Partially used bags of Ringer Lactate infusion solution MUST NOTbe reconnected.

USING A HIGHER DOSE OF RINGER LACTATE THAN RECOMMENDED

If too much Ringer Lactate infusion solution is used (overdose) or the medicine is administered too quickly, symptoms such as:

• fluid overload and (or) sodium overload with excessive fluid accumulation in tissues (edema) causing swelling;
• high potassium levels in the blood (hyperkalemia), especially in patients with kidney failure, causing symptoms such as:
• tingling sensation in hands and feet (paresthesia);
• muscle weakness;
• inability to move (paralysis);
• irregular heart rhythm (arrhythmia);
• heart block (very slow heart rhythm);
• cardiac arrest (the heart stops beating; a life-threatening condition);
• confusion.
• high calcium levels in the blood (hypercalcemia) causing symptoms such as:
• loss of appetite (anorexia);
• nausea;
• vomiting;
• constipation;
• abdominal pain;
• mental disorders such as irritability or depression;
• excessive thirst (polydipsia);
• excessive urination (polyuria);
• kidney disease caused by calcium accumulation in the kidneys (nephrocalcinosis);
• kidney stones;
• coma (loss of consciousness);
• bitter taste in the mouth;
• flushing (hot flashes);
• peripheral vasodilation (widening of blood vessels).
• low potassium levels in the blood (hypokalemia) and metabolic alkalosis (when the blood becomes too alkaline), especially in patients with kidney failure, causing symptoms such as:
• mood changes;
• fatigue;
• shortness of breath;
• muscle stiffness;
• muscle twitching;
• muscle cramps.

If the patient experiences any of these symptoms, inform the doctor immediately. The infusion will be stopped, and the doctor will provide treatment depending on the symptoms.
If another medicine was added to the infusion solution before the overdose, that medicine may also cause symptoms. Read the leaflet included with the added medicine to learn about possible symptoms.

STOPPING RINGER LACTATE TREATMENT

The doctor will decide when to stop the infusion.
If the patient has any further doubts about using this medicine, consult a doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ringer Lactate can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, contact a doctor or nurse immediately. These may be symptoms of a severe or life-threatening allergic reaction (anaphylaxis):

• hives, which may occur locally or affect the entire body;
• skin rash;
• redness of the skin (flushing);
• itching (pruritus);
• skin swelling (angioedema);
• cough;
• constriction of airways, making breathing difficult (bronchospasm);
• rapid heartbeat (tachycardia);
• slow heartbeat (bradycardia);
• low blood pressure;
• discomfort or pain in the chest;
• anxiety;
• chest tightness (making breathing difficult);
• shortness of breath (dyspnea);
• sudden flushing of the face;
• throat irritation;
• tingling and numbness (paresthesia);
• reduced sensation in the mouth (hypoesthesia);
• taste disturbances;
• fever;
• nausea;
• headache.

High potassium levels in the blood (hyperkalemia).
Low sodium levels in the blood, which may be related to hospital treatment (hospital-acquired hyponatremia) and associated neurological disorders (acute hyponatremic encephalopathy). Hyponatremia may lead to irreversible brain damage and death due to brain swelling (see also section 2 "WARNINGS AND PRECAUTIONS").
Reactions caused by the infusion technique, manifested by one or more of the following symptoms:

• local pain or reaction of redness or swelling at the infusion site;
• irritation and inflammation of the vein into which the solution is administered (phlebitis). This may cause redness, pain, or burning and itching along the vein into which the solution is administered;
• rash or itching (pruritus) at the infusion site.

Other side effects from similar medicines (other lactate-containing solutions) include:

• other symptoms of hypersensitivity/infusion reactions: nasal congestion (nasal stuffiness), sneezing, throat swelling making breathing difficult (angioedema), skin swelling (angioedema);
• changes in blood chemical levels (electrolyte disturbances);
• excessive blood volume (hypervolemia);
• panic attacks;
• other reactions related to the infusion technique: infection at the infusion site, leakage of the solution into the tissue surrounding the vein (extravasation). This may damage tissues and lead to scarring.

If another medicine is added to the infusion solution, it may also cause side effects. These will depend on the added medicine. Read the leaflet included with the added medicine to learn about possible side effects.

REPORTING SIDE EFFECTS

If the patient experiences any side effects not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 gather more information on the safety of this medicine.

5. HOW TO STORE RINGER LACTATE

Keep the medicine out of the sight and reach of children.
250 ml: Do not store above 30°C.
500 ml and 1000 ml: No special storage precautions.
Ringer Lactate should not be used after the expiry date stated on the bag (after "EXP"). The expiry date refers to the last day of the month.
Do not use Ringer Lactate if it contains visible particles or if the packaging is damaged in any way.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

WHAT RINGER LACTATE CONTAINS

The active substances are:

• sodium chloride: 6.00 g per liter
• potassium chloride: 0.40 g per liter
• calcium chloride dihydrate: 0.27 g per liter
• sodium lactate: 3.20 g per liter

The only excipient is water for injections.

WHAT RINGER LACTATE LOOKS LIKE AND CONTENTS OF THE PACKAGE

Ringer Lactate infusion solution is a clear solution, free from visible particles.
It is available in polyolefin/polyamide plastic bags (Viaflo). Each bag is placed in a closed, protective, plastic outer packaging.
Sizes of bags:

• 250 ml
• 500 ml
• 1000 ml

Sizes of packages:

• 30 bags of 250 ml in a carton
• 1 bag of 250 ml
• 20 bags of 500 ml in a carton
• 1 bag of 500 ml
• 10 bags of 1000 ml in a carton
• 12 bags of 1000 ml in a carton
• 1 bag of 1000 ml

Not all package sizes may be marketed.

MARKETING AUTHORIZATION HOLDER AND MANUFACTURERS

Marketing Authorization Holder:
Baxter Polska Sp. z o.o.
Kruczkowskiego 8
00-380 Warsaw
Manufacturers:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain
Date of last revision of the leaflet:August 2023
Baxter and Viaflo are trademarks of Baxter International Inc.
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The following information is intended for healthcare professionals only:

Handling and preparation

The medicinal product for parenteral use should be inspected visually for particulate matter and coloration prior to administration, whenever the solution and container permit. Do not use if the solution is not clear and the seal is broken.
Do not remove from the outer packaging until use.
The inner bag ensures the sterility of the product.
Administer immediately after connecting the infusion set.
Do not connect plastic containers in series. Such use could result in air embolism due to residual air in the primary container when the secondary container is added to the system. The application of additional pressure on intravenous infusion bags made of flexible plastic materials (e.g., Viaflex bags) during administration may cause air embolism when the bag is empty, if the bag is not fully evacuated. The use of infusion sets with an air vent (with the air vent in the open position) may also cause air embolism. Infusion sets with air vents (with the air vent in the open position) should not be used with flexible plastic containers (e.g., Viaflex bags).
Administer the intravenous solution using a sterile infusion set with aseptic technique. Fill the infusion set with solution to prevent air from entering the system.
Additional medications can be introduced into the solution before or during administration through the medication port. When using another medication, verify its compatibility with Ringer Lactate prior to parenteral administration. It is essential to mix thoroughly under aseptic conditions with each additional medication. Solutions containing additional medications should be used immediately, without storage.
The addition of other medications or improper infusion technique may cause the formation of precipitates or the introduction of particulate matter, resulting in febrile reactions. In the event of a reaction, discontinue the infusion immediately.

Opening

• Remove the Viaflo bag from the outer packaging immediately before use.
• By squeezing the inner bag, check for leakage. If leakage is found, the bag should be discarded, as the contents may not be sterile.
• Check that the solution is clear and free from visible particles. If the solution is not clear or contains particles, it should be discarded.

Preparation for administration

Use sterile materials during preparation and administration.

• Suspend the bag on a stand.
• Remove the plastic protector from the medication port at the bottom of the bag:
• grasp the smaller wing on the neck of the port with one hand;
• grasp the larger wing on the cap with the other hand and twist;
• the cap will pop off.
• When connecting the infusion set, follow aseptic technique.
• Connect the infusion set according to the manufacturer's instructions for the set, regarding connection, filling, and administration of the solution.

Methods of adding other medications

Caution: Added medications may be incompatible. Before use, verify the compatibility of the added medication with Ringer Lactate and the container. If another medication is added, verify its isotonicity prior to parenteral administration (see below "INCOMPATIBILITY OF ADDED MEDICATIONS").
Adding medications before administration

• Disinfect the medication port.
• Using a needle (19G to 22G), puncture the resealable medication port and inject the medication.
• Mix thoroughly after adding the medication. For dense preparations such as potassium chloride, gently tap the ports while the bag is in an upright position and mix.

Caution: Do not store bags containing added medications.
Adding medications during administration

• Close the roller clamp on the infusion set.
• Disinfect the medication port.
• Using a needle (19G to 22G), puncture the resealable medication port and inject the medication.
• Remove the bag from the stand and (or) turn it upside down.
• Empty both ports by gently tapping the bag while it is in an upright position.
• Mix thoroughly after adding the medication.
• Hang the bag in its original position, reopen the roller clamp, and continue the infusion.

Shelf life after opening: Added medications

Prior to use, establish the chemical and physical stability of each added medication in the pH range of Ringer Lactate in the Viaflo container.
From a microbiological point of view, the diluted product should be used immediately, unless reconstitution or dilution has been carried out under controlled and validated aseptic conditions. If the solution is not used immediately, the user is responsible for the storage conditions and time prior to administration.

INCOMPATIBILITY OF ADDED MEDICATIONS

Do not mix ceftriaxone with solutions containing calcium, including Ringer Lactate.
As with any parenteral nutrition solution, added medications may be incompatible. Before adding, evaluate the compatibility of the added medications with Ringer Lactate.
After adding incompatible medications, a visible change in color and (or) the formation of precipitates, insoluble complexes, or crystals may occur.
Consult the package leaflet of the added medication and relevant literature.
Before adding a substance or medication, verify its solubility and (or) stability in water at the pH of Ringer Lactate solution (pH 5.0 to 7.0).
When adding medications to Ringer Lactate, follow aseptic technique. Mix thoroughly after adding medications. Do not store solutions containing added medications.
Consider that the following substances are incompatible with Ringer Lactate ( list not exhaustive):

• Medications with pharmaceutical incompatibilities with Ringer Lactate:
• aminocaproic acid
• amphotericin B
• metaraminol bitartrate
• cefamandole
• ceftriaxone
• cortisone acetate
• diethylstilbestrol
• etamivan
• ethanol
• phosphate and carbonate solutions
• oxytetracycline
• sodium thiopental
• disodium edetate
• Medications with partial incompatibility with Ringer Lactate:
• tetracycline stability for 12 hours
• ampicillin sodium 2%-3% stability for 4 hours, concentrations >3% should be administered within 1 hour
• minocycline stability for 12 hours
• doxycycline stability for 6 hours

Do not use substances with known pharmaceutical incompatibilities.
Baxter and Viaflo are trademarks of Baxter International Inc.