Package leaflet: Information for the user

RINGER LACTATE BAXTER

Infusion solution
Sodium lactate + Sodium chloride + Potassium chloride + Calcium chloride dihydrate
Generic medicinal product
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

What RINGER LACTATE BAXTER is and what it is used for
What you need to know before you use RINGER LACTATE BAXTER
How to use RINGER LACTATE BAXTER
Possible side effects
How to store RINGER LACTATE BAXTER
Contents of the pack and other information

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

RINGER LACTATE BAXTER belongs to the class of electrolytes (substances essential for all cells to maintain a condition allowing them to perform their functions optimally).
This medicinal product is used:

In replacement therapy for extracellular fluid and electrolyte losses, when correction of mild to moderate, but not severe, acidotic states (increased blood acidity) is required.
In the treatment of mild or moderate, but not severe, hemorrhagic shock (a pathological condition caused by a significant decrease in circulating blood).

2. WHAT YOU NEED TO KNOW BEFORE USING RINGER LACTATE BAXTER

Do not use RINGER LACTATE BAXTER

If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
If you have severe renal insufficiency (reduced kidney function).
If you have hypercalcemia (increased calcium levels in the blood), hypercalciuria (high calcium concentration in urine), or severe kidney diseases.
In case of hypernatremia (elevated sodium concentration in the blood).
In case of hypervolemia (excess fluid and salt accumulation).
In case of hyperkalemia (elevated potassium concentration in the blood) or conditions involving potassium retention.
In case of ventricular fibrillation (heart rhythm disorder). Calcium chloride may increase the risk of arrhythmias.
In case of metabolic or respiratory alkalosis (decreased blood acidity).
If you have kidney stones (the condition may worsen with calcium administration).
If you suffer from sarcoidosis (an inflammatory disease that may affect all organs). Hypercalcemia typical of this condition may be exacerbated.
In case of hypercoagulability (abnormal blood coagulation). 1 of 13
If you are concurrently receiving treatment with cardioactive glycosides (see "Other medicines and RINGER LACTATE BAXTER").
If you have untreated Addison's disease (a condition caused by reduced adrenal cortex function).
In case of heat cramps (muscle cramps due to physical exertion and caused by water intake without salt replacement).

During blood transfusions, this solution must not be administered through the same
infusion catheter as whole blood due to the possible risk of coagulation.
As with all infusion solutions containing calcium, concomitant administration of
ceftriaxone and RINGER LACTATE BAXTER is contraindicated in neonates (less than 28 days of age), even
if separate infusion lines are used (risk of fatal precipitation of calcium-ceftriaxone salts in the
neonate's bloodstream) (see "Children and adolescents", "Other medicines and RINGER LACTATE
BAXTER", and section 4 "Possible side effects").
Warnings and precautions
RINGER LACTATE BAXTER solution is irritating and must not be administered
intramuscularly, subcutaneously (under the skin), or into peri-vascular tissue (around blood vessels),
as tissue necrosis (tissue death) may occur.
The medicine should be administered with caution in patients:

With renal insufficiency (reduced kidney function); administration of solutions containing potassium ions in patients with impaired renal function may cause potassium and sodium retention.
With cardiac insufficiency (reduced heart function), especially if being treated with digitalis drugs (medicines acting on heart function).
With adrenal insufficiency (reduced adrenal gland function).
With hepatic insufficiency (reduced liver function).
With familial periodic paralysis (a muscle disorder with functional disturbances).
With congenital myotonia (a pathological condition present from birth characterized by prolonged muscle contraction).
In the early postoperative phase.
With kidney disease, cor pulmonale (enlargement of the right ventricle of the heart caused by lung disease), respiratory failure, or respiratory acidosis (a condition characterized by irritability, headache, anorexia, drowsiness, potentially progressing to coma, caused by carbon dioxide accumulation in the blood due to diseases leading to respiratory failure). In these situations, acidification caused by calcium chloride may worsen the clinical picture.
Who are in conditions where there is an increased risk of hypercalcemia (high calcium levels in blood), such as chronic renal failure, dehydration (excessive fluid loss), or electrolyte imbalance.
With heart conditions, as calcium salts may increase the risk of arrhythmias.
Who are in a condition that may cause elevated levels of vasopressin, a hormone regulating body fluids. You may have excessive vasopressin in your body, for example, if:
you have an acute illness
you have pain
you have undergone surgery
you have infections, burns, or brain diseases
you have diseases affecting your heart, liver, kidneys, or central nervous system, or are taking certain medications (see also below "Other medicines and Ringer Lactate Baxter") This may increase the risk of low sodium levels in your blood and may lead to headache, nausea, seizures, lethargy, coma, or cerebral edema. Cerebral edema increases the risk of death and severe, irreversible, life-threatening brain damage. People at higher risk of cerebral edema include:
children
women (especially those of childbearing age) 2 of 13

people with conditions affecting their cerebral fluid levels, for example due to meningitis,
intracranial hemorrhage, or brain injury

Due to the presence of sodium, administer the medicine with caution:

In patients with congestive heart failure (a pathological condition caused by the heart's inability to pump adequate blood to meet the body's needs).
In case of severe renal insufficiency (reduced kidney function).
In clinical states associated with edema (swelling) with hydro-saline retention (water and salt).
In patients receiving treatment with cardiac inotropic drugs (stimulating heart function) or corticosteroid drugs (anti-inflammatory), or corticotropin drugs (used to assess adrenal gland function), or
In patients with hypertension (high blood pressure).
In case of cardiac insufficiency.
In patients with peripheral or pulmonary edema.
In patients with reduced renal function.
In case of pre-eclampsia (a specific pregnancy condition characterized by edema, protein in urine, and high blood pressure), or other conditions associated with sodium retention (see "Other medicines and RINGER LACTATE BAXTER").

Due to the presence of calcium, the medicine must be used with great caution in patients:

With kidney diseases, particularly if they have had kidney stones.
With heart conditions.
Who have received a blood transfusion, as calcium ion concentrations may differ from expected levels.

Due to the presence of lactate, the medicine must be used with caution:

In patients with lactic acidosis (a pathological condition characterized by increased blood acidity).
In case of impaired oxidative processes preventing lactate utilization, such as shock or hypoxemia (a condition characterized by reduced oxygen concentration in the blood).

RINGER LACTATE BAXTER is not indicated for the treatment of lactic acidosis or severe metabolic
acidosis.
This medicine should not be administered to patients with conditions associated with elevated
lactate levels or impaired lactate utilization, such as severe hepatic insufficiency; however, if strictly necessary, it should be administered with particular care.
In patients with severe hepatic insufficiency, lactate metabolism may be impaired; therefore, RINGER LACTATE BAXTER may fail to exert its alkalizing effect and hyperlactatemia (elevated lactate concentration in blood) may develop.
This should be taken into account when RINGER LACTATE BAXTER is used in patients with type 2 diabetes.
Due to the presence of potassium, administration should be guided by serial electrocardiograms
(repeated ECGs); serum potassium levels (blood potassium concentration) do not reliably reflect intracellular potassium concentrations. High potassium concentrations in the blood may cause death due to cardiac depression, arrhythmias (heart rhythm disturbances), or cardiac arrest. To avoid potassium intoxication,
infusion must be performed at a controlled rate (see section 3 "How to use RINGER LACTATE BAXTER").
The potassium concentration in RINGER LACTATE BAXTER is similar to that in blood; nevertheless, this medicine is not indicated in cases of severe potassium deficiency.
Administration of calcium chloride may cause vasodilation (dilation of blood vessels) resulting in decreased blood pressure.
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Due to the risk of coagulation precipitates from its calcium content, RINGER LACTATE BAXTER must not be mixed or administered simultaneously through the same line with citrate anticoagulants used to preserve blood.
Immediately discontinue infusion if signs or symptoms of suspected hypersensitivity (allergy) occur; appropriate therapeutic countermeasures should be instituted as clinically indicated.
Intravenous administration of the medicine, depending on volume and infusion rate, may cause:

Hyperhydration/hypervolemia and, for example, congestive states, including pulmonary congestion and edema due to fluid overload;
Clinically significant electrolyte imbalances and acid-base imbalance (see "Children and adolescents").

RINGER LACTATE BAXTER should not be administered to patients in conditions predisposing to hyperkalemia (such as severe kidney damage or adrenocortical insufficiency, severe dehydration, or extensive tissue damage or burns) and in patients with cardiac insufficiency; however, if strictly necessary, it should be administered with particular care.
RINGER LACTATE BAXTER should not be administered to patients at risk of alkalosis; however, if strictly necessary, it should be administered with particular care. Since lactate is metabolized into bicarbonate, administration may cause or worsen metabolic alkalosis.
RINGER LACTATE BAXTER should not be administered to hypervolemic or hyperhydrated patients; however, if strictly necessary, it should be administered with particular care.
RINGER LACTATE BAXTER should not be administered to patients with conditions that may cause sodium retention, fluid overload, and edema, such as patients with primary hyperaldosteronism, secondary hyperaldosteronism (associated, for example, with hypertension, congestive heart failure, renal artery stenosis, or nephrosclerosis), or pre-eclampsia; however, if strictly necessary, it should be administered with particular care.
During infusion of the medicine, continuous ECG monitoring is essential, and it is good practice to monitor fluid balance, electrolytes, plasma osmolarity (blood osmotic pressure), and acid-base balance.
Serum and urine calcium concentrations should be monitored frequently to prevent hypercalciuria (excessive calcium loss in urine), as hypercalciuria may progress to hypercalcemia (excessive calcium levels in blood).
Do not use plastic containers connected in series, as they may cause gas embolism due to residual air from the primary container.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates may cause gas embolism if residual air in the container is not completely removed before administration.
Using an intravenous administration set with the vent in the open position may cause gas embolism. Intravenous administration sets with the vent in the open position must not be used with flexible plastic containers.
Use in elderly patients
The choice of type and volume/infusion rate will be decided by the physician, considering that elderly patients generally have a higher probability of having heart, kidney, liver, or other diseases or of receiving concomitant therapy.
Use immediately after opening the container.
The solution must be clear, colorless, and free from visible particles.
This medicine is intended for single, uninterrupted administration; any residual solution must not be reused.
Children and adolescents
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In children, the safety and efficacy of the medicine have not been established.
Lactate-containing solutions must be administered with particular care in neonates and children under 6 months of age.
Other medicines and RINGER LACTATE BAXTER
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Some drugs affect the hormone vasopressin. These may include:

antidiabetic drugs (chlorpropamide)
cholesterol-lowering drugs (clofibrate)
anticonvulsants (carbamazepine)
certain oncology drugs (vincristine, ifosfamide, cyclophosphamide)
selective serotonin reuptake inhibitors (used to treat depression) such as
3,4-methylenedioxy-N-methamphetamine
antipsychotics
narcotics
analgesic and/or anti-inflammatory drugs (also known as NSAIDs), and drugs that mimic or enhance the effect of vasopressin, such as desmopressin, oxytocin, terlipressin, vasopressin
Other medicines that increase the risk of hyponatremia also include diuretics in general and antiepileptics such as oxcarbazepine.

RINGER LACTATE BAXTER must be administered with caution when used in combination with:

Potassium-sparing diuretics (drugs that increase urine production while preserving potassium) (amiloride, spironolactone, triamterene); such combination may increase the risk of hyperkalemia (high potassium levels in blood), especially in the presence of renal dysfunction. Therefore, in such cases, blood potassium levels must be closely monitored.
Angiotensin II receptor antagonists (medicines used to treat hypertension) or immunosuppressants tacrolimus and cyclosporine due to potassium content and the risk of severe and potentially fatal hyperkalemia, especially in patients with severe renal insufficiency.
ACE inhibitors (medicines used to lower blood pressure); these drugs reduce aldosterone levels and may lead to potassium retention; therefore, blood potassium levels must be closely monitored.
Corticosteroid drugs (anti-inflammatory); these drugs are associated with sodium and water retention, leading to edema (fluid accumulation) and hypertension (see "Warnings and precautions").
Thiazide diuretics or vitamin D; hypercalcemia may occur due to reduced renal calcium excretion.
Cardioactive glycosides (digitalis), digoxin, and digitoxin, as concomitant use may increase the risk of severe or fatal arrhythmias, considering that inotropic (increased heart function) and toxic effects are synergistic (mutually enhancing).
Verapamil (and other calcium channel blockers), as concomitant use may reduce verapamil's antihypertensive effect.
Medicines containing magnesium, as this may increase the risk of hypercalcemia or hypermagnesemia (increased magnesium concentration in blood), especially in patients with renal disorders.
Neuromuscular blocking agents (drugs used to achieve muscle relaxation during surgery); calcium salts may counteract the effect of non-depolarizing blockers. In some cases, increased and prolonged action of tubocurarine (a neuromuscular blocker) has also been observed.
Medicines whose renal elimination depends on pH. Due to its alkalizing effect (bicarbonate formation), the medicine may interfere with the elimination of acidic drugs such as salicylates, barbiturates, and lithium, whose renal clearance may be increased, and

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alkaline drugs, such as sympathomimetics (e.g., ephedrine, pseudoephedrine), phenfluramine
hydrochloride or dextroamphetamine (dexamfetamine) sulfate, whose renal clearance may be decreased.

Ceftriaxone: this combination is contraindicated in neonates (under 28 days of age), even when separate infusion lines are used (fatal risk of precipitation of calcium-ceftriaxone salt in the neonate's bloodstream; see section 4 "Possible side effects"). In patients over 28 days of age (including adults), ceftriaxone must not be administered concomitantly with intravenous solutions containing calcium, including RINGER LACTATE BAXTER, through the same infusion line (e.g., via a Y-connector). If the same line is used for sequential administration, the line must be flushed with a compatible fluid between infusions.

Pregnancy, breastfeeding, and fertility
You must inform your doctor if:

You are pregnant or think you may be pregnant.
You are planning a pregnancy.
You are breastfeeding.

The medicine must not be used during pregnancy or breastfeeding unless absolutely necessary and only after the doctor has evaluated the risk/benefit ratio.
No data are available on possible adverse effects of the medicine when administered during pregnancy or breastfeeding or on reproductive capacity.
Ringer Lactate Baxter must be administered with particular caution in pregnant women during labor, especially regarding serum sodium, if administered in combination with oxytocin (see sections Warnings and Precautions, How to use Ringer Lactate Baxter, and Possible Side Effects).
Driving and using machines
The medicine does not affect the ability to drive or use machinery.

3. HOW TO USE RINGER LACTATE BAXTER

Your treatment with RINGER LACTATE BAXTER will be supervised by a physician. The physician will determine the amount of RINGER LACTATE BAXTER to administer and will prepare the medicinal product.
The solution is isotonic (has the same concentration) as blood and must be administered by intravenous infusion (into a vein) with caution and at a controlled infusion rate, using sterile and pyrogen-free equipment.
Do not administer the solution if it is not clear or if the seal is broken; parenteral medicinal products should be visually inspected for particulate matter and discoloration.
Shake well during preparation and before use.
The medicinal product should be administered only if renal function is normal and at a rate not exceeding 10 milliequivalents of potassium per hour.
Infusions that are too rapid may cause local pain, and the infusion rate must be adjusted according to tolerance.
Do not inject intramuscularly (into muscle), subcutaneously (under the skin), or into perivascular tissues (around blood vessels).
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Before and during administration, the physician will monitor fluid and electrolyte levels in the body, particularly sodium levels in the blood.
Administration must be discontinued if the patient experiences pain or redness at the injection site, as this may indicate extravasation of the drug.
It is advisable for the patient to remain lying down for a short period after administration.
The usual adult dose is generally about 20–30 mL of solution/kg body weight, up to a maximum of 40 mL of solution/kg body weight.
If used to dilute medicinal products, consult the pharmacist, if possible, before adding additive drugs; always consider the characteristics of the products to be added; when adding additive drugs, use aseptic (sterile) techniques.

Incompatibilities with RINGER LACTATE BAXTER
The medicinal product is incompatible with:

Magnesium sulfate: formation of a precipitate (formation of an insoluble solid).
Medicinal products containing phosphate: formation of calcium phosphate precipitate.
Medicinal products containing carbonate: formation of calcium carbonate precipitate.
Medicinal products containing tartrate: formation of calcium tartrate precipitate.
Aminophylline: formation of a precipitate.
Amphotericin B: development of cloudiness.
Cefamandole.
Sodium ceftriaxone: formation of precipitate; administration of RINGER LACTATE BAXTER must not occur within 48 hours following administration of ceftriaxone (see “Do not take RINGER LACTATE BAXTER” and “Other medicines and RINGER LACTATE BAXTER”).
Cephalothin: physical incompatibility.
Cefradine.
Chlorpheniramine: physical incompatibility.
Dobutamine: development of cloudiness.
Fat emulsion: flocculation (formation of flakes in suspension).
Sodium heparin.
Indomethacin: formation of precipitate.
Sodium nitrofurantoin.
Promethazine: formation of precipitate.
Propofol: formation of precipitate.
Streptomycin: calcium may block the activity of streptomycin.
Tetracyclines: calcium salts may complex with tetracyclines.

Use immediately after opening the container. The container is intended for single, uninterrupted administration and any remaining residue must not be used.
Do not use the medicinal product if the solution is not clear and colorless or if it contains particles.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.

If you use more RINGER LACTATE BAXTER than you should
High concentrations of potassium in the blood can cause death due to cardiac depression, arrhythmias, or cardiac arrest.
Excessive administration of sodium chloride may lead, depending on the patient's clinical condition, to hypernatremia (elevated sodium concentration in the blood) and/or hypervolemia (increased blood volume). Hypernatremia and excessive sodium retention, particularly when renal sodium excretion is impaired, may result in dehydration of internal organs, especially the brain, and accumulation of extracellular fluid (outside the cells) causing edema that may affect the cerebral, pulmonary, and peripheral circulation, leading to pulmonary and peripheral edema.
Excessive administration of lactate may lead to metabolic alkalosis, which may be accompanied by hypokalemia.
Excessive administration of potassium may lead to the development of hyperkalemia, especially in patients with severe renal insufficiency.
Accumulation of chloride ions leads to a reduction in bicarbonate ion concentration, resulting in acidosis.
In case of excessive administration of calcium chloride, hypercalcemia may occur, particularly in patients with renal disease. Typical symptoms of hypercalcemia include thirst, nausea, vomiting, constipation, polyuria (excessive urine production), abdominal pain, muscle weakness, mental disturbances, and in severe cases, cardiac arrhythmias and coma. Hypercalcemia is defined as serum calcium levels exceeding 2.6 mmol/L; therefore, such levels must be continuously monitored.
When assessing an overdose, any medicinal products added to the solution must also be taken into account.
In case of administration of an excessive dose of RINGER LACTATE BAXTER, immediately discontinue the infusion and initiate corrective therapy to reduce blood levels of excess ions and, if necessary, restore acid-base balance (see “Warnings and precautions”).
The patient should be kept under observation to monitor for any signs and symptoms related to the administered drug, to ensure appropriate symptomatic and supportive measures as needed.
In case of elevated natremia, loop diuretics may be used.
In case of hyperkalemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
In case of mild overdose of calcium chloride, treatment involves immediate discontinuation of the infusion and of any other calcium-containing medicinal products. In case of severe overdose (plasma concentrations greater than 2.9 mmol/L), the following measures should be taken:

Rehydration by administration of 0.9% sodium chloride solution.
Use of non-thiazide diuretics to promote calcium excretion.
Monitoring of potassium and calcium levels in the blood with immediate correction to normal values.
Monitoring of cardiac function; use of beta-blockers to reduce the risk of cardiac arrhythmias.
Possible recourse to hemodialysis (a physical therapy replacing kidney function). Elevated electrolyte levels in the blood may require dialysis.

If you have any doubts about the use of this medicinal product, consult your doctor or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Possible adverse reactions include:

Gastrointestinal disturbances and irritation, thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain, constipation, metallic taste, chalky taste.
Neuromuscular disturbances, muscle rigidity, paresthesia (altered sensation in limbs or other body parts), flaccid paralysis (loss of voluntary movement associated with decreased muscle tone), weakness, mental confusion, headache, dizziness, restlessness, irritability, seizures, coma, death, acute hyponatremic encephalopathy*.
Drowsiness, confusion, mental disorders.
Arrhythmias, tachycardia (increased heart rate), bradycardia (decreased heart rate), conduction disturbances, disappearance of the P wave, widening of the QRS complex on electrocardiogram, syncope (transient loss of consciousness), ventricular fibrillation (severe cardiac decompensation), cardiac arrest. 8 of 13
Hypotension, hypertension, peripheral edema, vasodilation, hot flushes.
Hypernatremia, hypervolemia, hyperchloremia.
Dyspnea (difficulty breathing), respiratory arrest, pulmonary edema, pneumothorax (a condition with sudden onset characterized by accumulation of air in the space between the lung and the chest wall).
Reduced tear production.
Renal failure, polyuria (excessive urine production).
Hypercalcemia, Burnett's syndrome (a condition caused by excessive intake of calcium-rich foods), hyperkalemia, hospital-acquired hyponatremia*.
Muscle weakness.
Feverish reactions, infection at infusion site, pain or local reaction, redness, rash, venous irritation, thrombosis (a pathological process involving formation of blood clots within blood vessels, obstructing or preventing normal blood flow) or venous phlebitis (inflammation of veins) extending from the infusion site, extravasation, tissue necrosis, abscess formation (collection of pus within tissue), cutaneous calcification (calcium salt deposition in tissues). At the infusion site, inflammation, swelling, itching, erythema, burning, anesthesia (numbness) may occur.
Hypersensitivity reactions (allergy) to the infusion, including anaphylactic/anaphylactoid reactions with the following manifestations: angioedema (rapid swelling of subcutaneous and submucosal tissues), chest pain, chest discomfort, reduced heart rate, tachycardia, drop in blood pressure, breathing difficulties, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesias, hypoesthesia of the oral cavity, dysgeusia, nausea, anxiety, pyrexia, migraine.
Precipitation of calcium-ceftriaxone salt (see “Other Medicines and RINGER LACTATE BAXTER”)

*Hospital-acquired hyponatremia may lead to irreversible brain damage and death due to the development of acute hyponatremic encephalopathy, frequency not known (see sections “How to use RINGER LACTATE BAXTER”, “Warnings and Precautions”, and “Other Medicines and RINGER LACTATE BAXTER”).

Additional adverse reactions in children and adolescents
Severe, and in some cases fatal, adverse reactions have been rarely reported in preterm and full-term neonates (under 28 days of age) treated with intravenous ceftriaxone and calcium. Post-mortem findings revealed precipitation of calcium-ceftriaxone salt in the lungs and kidneys.
Cases of renal precipitation have been reported, primarily in children over 3 years of age receiving high daily doses (e.g., greater than 80 mg/kg per day) or total doses exceeding 10 grams, and who had other risk factors (e.g., fluid restriction, bedridden patients). The risk of precipitate formation increases in immobilized or dehydrated patients. This event may be symptomatic or asymptomatic, may lead to renal failure and anuria, and is reversible upon discontinuation of administration.

Calcium-ceftriaxone salt precipitation in the gallbladder has been observed, mainly in patients treated with doses exceeding the recommended standard dose. Prospective studies in children have shown variable incidence of precipitation with intravenous administration; in some studies, the incidence exceeded 30%. This incidence appears lower when infusions are administered slowly (over 20–30 minutes). This effect is generally asymptomatic, but in rare cases precipitations have been associated with clinical symptoms such as pain, nausea, and vomiting. In such cases, symptomatic treatment is recommended. Precipitation is generally reversible upon discontinuation of administration.

If you experience any of the following potentially serious adverse reactions:
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If you are in hospital: inform your doctor or nurse immediately.
After leaving hospital: go immediately to the Emergency Department of the nearest hospital.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report adverse reactions directly via
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE RINGER LACTATE BAXTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month and applies to the product in its original, undamaged packaging stored under proper conditions.
The solution should be clear, colourless, and free from visible particles.
This medicine is intended for single, continuous administration; any remaining solution must not be used.
Use immediately after opening the container.
Store in the original packaging and in a tightly closed container.
Do not refrigerate or freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What RINGER LACTATE BAXTER contains
1000 ml of solution contains:
Active substances:
Sodium (S)-Lactate 60% solution 5.39 g
Sodium Chloride 6 g
Potassium Chloride 0.4 g
Calcium Chloride Dihydrate 0.27 g
Other components:
Water for injections, q.s.
Hydrochloric acid, q.s. to adjust pH to 5.5 – 7.0
milliequivalents/litre: Na 132
K 5
Ca 4
Cl 112
Lactate 29
Theoretical osmolarity: (mOsm/litre) 280
pH: 5.5–7
Description of the appearance of RINGER LACTATE BAXTER and packaging contents
Infusion solution, sterile and free from bacterial endotoxins.
Clear, colourless solution, free from visible particles.
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Various pack sizes are available:
Glass bottles: 50, 100, 250 and 500 ml Single packaging
Glass bottles 500 ml Pack of 20 units
ClearFlex flexible bags: 100, 250, 500 and 1000 ml. Single packaging
ClearFlex and Viaflo flexible bags: 500 ml Pack of 20 units
ClearFlex and Viaflo flexible bags: 1000 ml Pack of 12 units
Viaflo flexible bags: 500 ml Pack of 24 units
Viaflo flexible bags: 1000 ml Pack of 10 units
Marketing Authorisation Holder
BAXTER S.p.A. - Piazzale dell’Industria 20 – 00144 Rome, Italy.
Manufacturer
BIEFFE MEDITAL S.p.A. - Via Nuova Provinciale - 23034 Grosotto (SO), Italy.
BIEFFE MEDITAL S.A. Ctra de Biescas - 22666 Sabiñánigo (Spain).

The following information is intended exclusively for physicians or healthcare professionals:
Dosage, method and duration of administration
The solution is isotonic with blood and must be administered by intravenous infusion with caution and at a controlled infusion rate, using sterile and pyrogen-free equipment.
Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer if the solution is not clear or if the seal is not intact.
Electrolyte balance, serum electrolytes and acid-base balance must be monitored before and during administration, with particular attention to serum sodium in patients with non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists, due to the risk of hospital-acquired hyponatremia (see sections Warnings and Precautions, How to use Ringer Lactate Baxter and Possible Side Effects).
Monitoring of serum sodium is particularly important for hypotonic solutions.
Tonicity of Ringer Lactate Baxter: approximately 280 mOsm/l
Infusion rate and volume depend on age, weight, clinical condition (e.g. burns, surgical procedures, head injuries, infections) and concomitant therapy, and must be determined by a physician experienced in paediatric intravenous therapy (see sections Warnings and Precautions and Possible Side Effects).
Shake well during preparation and before use.
The medicine should be administered only if renal function is intact and at a rate not exceeding 10 mEq potassium/hour.
Adults
Generally, the dose is about 20–30 ml of solution/kg body weight, up to a maximum of 40 ml of solution/kg body weight.
Children
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In children, the safety and efficacy of the medicine have not been established.
Infusions that are too rapid may cause local pain; the infusion rate should be adjusted according to tolerance.
Do not inject intramuscularly, subcutaneously or into perivascular tissues.
Administration must be discontinued if the patient experiences pain or redness at the injection site, as this may indicate extravasation of the drug.
It is advisable for the patient to remain lying down for a short period after administration.
Warnings and precautions
Use immediately after opening the container. The container is intended for single, uninterrupted administration and any residual solution must not be used.
Shake well before administration. Do not use the medicine if the solution is not clear and colourless or if it contains particles.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.
When selecting the type of solution and the volume/infusion rate for elderly patients, consider that elderly patients generally have a higher likelihood of underlying conditions such as cardiac, renal or hepatic impairment, and consider also concomitant pharmacological therapies.
Do not connect flexible plastic containers in series to avoid gas embolism due to possible residual air in the primary container.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates may cause gas embolism if residual air in the container is not completely removed before administration.
Using an intravenous administration set with the vent in the open position may cause gas embolism. Intravenous administration sets with the vent in the open position must not be used with flexible plastic containers.
Infusion of large volumes should be used under specific monitoring conditions in patients with cardiac or pulmonary insufficiency and in patients with non-osmotic release of vasopressin (including SIADH), due to the risk of hospital-acquired hyponatremia.
Hyponatremia (low plasma sodium concentration)
Patients with non-osmotic release of vasopressin (e.g. during acute illness, pain, postoperative stress, infections, burns and central nervous system disorders), patients with heart, liver or kidney disease, and patients receiving vasopressin agonists (see section Other medicines and Ringer Lactate Baxter) are particularly at risk of acute hyponatremia following infusion of hypotonic solutions.
Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral oedema), characterized by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral oedema are particularly at risk of severe, irreversible and life-threatening brain injury.
Children, women of childbearing age and patients with reduced cerebral compliance (e.g. meningitis, intracranial haemorrhage, contusion and cerebral oedema) are particularly at risk of severe, life-threatening cerebral oedema caused by acute hyponatremia.
If used to dilute medicinal products, consult a pharmacist, if available, before adding additives; always consider the characteristics of the products to be added, checking for any change in colour and/or formation of precipitates, insoluble complexes or crystals. Before adding any substance or medicinal product, verify that it is soluble and/or stable in water and that the pH range of Ringer Lactate is appropriate. Additives known to be incompatible must not be used (see “Incompatibilities with Ringer Lactate Baxter”).
Use aseptic techniques; mix the solution thoroughly when additives are added; do not store solutions containing added medicinal products.
Overdose
Symptoms
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias or arrest.
Excessive administration of sodium chloride may lead, depending on the patient's clinical condition, to hypernatremia and/or hypervolemia. Hypernatremia and excessive sodium retention, especially when renal sodium excretion is impaired, may cause dehydration of internal organs, particularly the brain, and accumulation of extracellular fluid with oedema affecting the cerebral, pulmonary and peripheral circulation, leading to pulmonary and peripheral oedema.
Excessive administration of lactate may lead to metabolic alkalosis, which may be accompanied by hypokalaemia.
Excessive administration of potassium may lead to hyperkalaemia, especially in patients with severe renal insufficiency.
Accumulation of chloride ions leads to reduced bicarbonate ion concentration, resulting in acidosis.
Excessive administration of calcium chloride may cause hypercalcaemia, particularly in patients with renal disease. Typical symptoms of hypercalcaemia include thirst, nausea, vomiting, constipation, polyuria, abdominal pain, muscle weakness, mental disturbances and, in severe cases, cardiac arrhythmias and coma. Hypercalcaemia is diagnosed when plasma calcium concentrations exceed 2.6 mmol/l; therefore, plasma calcium levels must be constantly monitored.
When assessing overdose, any additives to the solution must also be considered.
The effects of an overdose may require immediate medical attention and treatment.
Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of excess ions and, if necessary, restore acid-base balance (see Warnings and Precautions).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, ensuring appropriate symptomatic and supportive measures as needed.
In cases of severe hypernatremia, loop diuretics may be used.
In cases of hyperkalaemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
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Ringer's lactate Baxter