RINGER 100 ML Инфузионный раствор

Содержание инструкции

1. RINGER LATTATO S.A.L.F. infusion solution
   1. What is RINGER LATTATO S.A.L.F. and what is it used for
   2. What you need to know before using RINGER LACTATE S.A.L.F.
   3. How to use RINGER LATTATO S.A.L.F.
   4. Possible side effects
   5. How to store RINGER LATTATO S.A.L.F.
   6. Package Contents and Other Information

RINGER LATTATO S.A.L.F. infusion solution

Sodium chloride, potassium chloride, calcium chloride dihydrate, sodium lactate
Equivalent medicinal product

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What RINGER LATTATO S.A.L.F. is and what it is used for
• 2. What you need to know before you use RINGER LATTATO S.A.L.F.
• 3. How to use RINGER LATTATO S.A.L.F.
• 4. Possible side effects
• 5. How to store RINGER LATTATO S.A.L.F.
• 6. Contents of the pack and other information

1. What is RINGER LATTATO S.A.L.F. and what is it used for

RINGER LATTATO S.A.L.F. is an infusion solution to be injected directly into a vein that contains
a combination of active ingredients: sodium chloride, potassium chloride, calcium chloride dihydrate and sodium lactate.
This medicine is indicated:

• to provide the body with water and mineral salts following losses of extracellular fluids and mineral salts, in order to restore normal salt levels, useful for the correct functioning of the body and restore the normal pH of the blood, when an increase in acidity (mild or moderate acidosis) occurs;
• to restore normal blood pressure following shock caused by significant blood loss (mild or moderate hemorrhagic shock).

2. What you need to know before using RINGER LACTATE S.A.L.F.

Do not use RINGER LACTATE S.A.L.F.

• if you are allergic to sodium chloride, potassium chloride, calcium chloride dihydrate, sodium lactate or any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (renal failure);
• if you have high levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria) or suffer from serious kidney diseases;
• if you have high levels of sodium in the blood (hypernatremia) or of other mineral salts (hydrosaline plethora);
• if you have high levels of potassium in the blood (hyperkalemia) or decreased ability to eliminate potassium (potassium retention);
• if you have an alteration of the heartbeat called ventricular fibrillation, because calcium chloride may increase the risk of irregular heartbeat (arrhythmias);
• if you have kidney stones, which may increase with the administration of calcium;
• if you have a chronic systemic disease called sarcoidosis which may enhance the increase of calcium levels in the blood (hypercalcemia);
• if you have circulation problems due to a high tendency of the blood to coagulate (hypercoagulability);
• if you are taking medicines for heart diseases called cardiac glycosides (see section “Other medicines and RINGER LACTATE S.A.L.F.”);
• if you have an increase in blood pH (metabolic and respiratory alkalosis);
• if you suffer from a disease of the adrenal glands (Addison's disease) and are not following any therapy to treat it;
• if you experience painful and short-lived muscle cramps (heat cramps);
• if the patient is a newborn (less than 28 days of age), RINGER LACTATE S.A.L.F. (or other calcium solutions) should not be administered at the same time as ceftriaxone (an antibiotic), even if separate infusion lines are used. There is a fatal risk of particle formation in the newborn's bloodstream. In conjunction with blood transfusions, the solution should not be administered through the same infusion catheter with whole blood due to the possible risk of blood coagulation.

Warnings and precautions
Consult your doctor, pharmacist or nurse before using RINGER LACTATE S.A.L.F.
This medicine must be administered to you via a very slow infusion, as it may
manifest potassium intoxication which can lead to death due to loss of heart function
(cardiac depression), problems with irregular heartbeat (arrhythmias) up to cardiac arrest
(See section “How to use RINGER LACTATE S.A.L.F.”).
If you develop signs or symptoms of a suspected hypersensitivity, the infusion must be stopped
immediately.
This medicine must be administered with caution and under specific monitoring for the
risk of reduction of sodium concentration in the plasma (hyponatremia) if:

• you have heart problems (heart failure) or lung problems (pulmonary failure);
• you have a liver and/or kidney disease (hepatopathy and/or nephropathy);
• you present a non-osmotic release of the antidiuretic hormone (vasopressin) including the syndrome of inappropriate secretion of vasopressin (SIADH) or are undergoing therapy with vasopressin agonists. Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral edema are particularly at risk of severe, irreversible and life-threatening brain injury. Children, women of childbearing potential and patients with reduced cerebral compliance (e.g. meningitis, intracranial hemorrhage and cerebral contusion) are particularly at risk of severe and life-threatening brain fluid accumulation (cerebral edema) caused by acute hyponatremia. Due to the presence of sodium, this medicine must be administered with caution in the following cases:
• if you have heart problems (congestive heart failure, heart failure);
• if you have kidney problems (renal failure);
• if you have fluid accumulation (edema with salt retention) both in the lung (pulmonary edema), and associated with swelling of the ankles and legs (peripheral edema);
• if you are taking medicines for the heart (cardiotropic drugs), anti-inflammatory corticosteroids or hormonal medicines (corticotrophins);
• if you have high blood pressure (hypertension);
• if you suffer from a disease called pre-eclampsia characterized by high blood pressure, swelling due to fluid accumulation and the presence of protein in the urine, or other conditions caused by sodium accumulation.

Due to the presence of potassium, this medicine must be administered with caution in the following cases:

• if you have kidney problems (renal failure), because it can cause potassium retention;
• if you have heart problems (heart failure) and are taking other medicines for the heart (digitalis);
• if you have a disease of the adrenal glands (adrenal insufficiency);
• if you have liver problems (hepatic insufficiency);
• if someone in your family suffers from a disorder characterized by sudden muscle weakness (periodic paralysis);
• if you suffer from a disease characterized by muscle stiffness (congenital myotonia);
• if you have recently undergone surgery (early postoperative phase). This medicine should not be used to treat potassium deficiencies.

Due to the presence of calcium, this medicine must be administered with great caution in the following cases:

• if you have kidney problems (renal failure) or heart problems, as it may increase the risk of irregular heartbeat (arrhythmias);
• if you have received a blood transfusion as the concentrations of calcium ions may be different from those expected;
• if you suffer from lung problems that can cause enlargement of the heart (cor pulmonale);
• if you have difficulty breathing (respiratory failure) or have a decrease in blood pH (respiratory acidosis);
• if you have low water levels in the body (dehydration) or have an electrolyte imbalance (electrolyte imbalance);
• if you have low blood pressure, because the administration of calcium chloride can cause vasodilation with consequent lowering of blood pressure;
• if you have suffered from kidney stones. Calcium chloride solution is irritating and, therefore, should not be administered by injection into the muscle (intramuscularly) or under the skin (subcutaneously) or into the tissue surrounding blood vessels (peri-vascularly), as tissue damage and death (necrosis) may occur. Due to the presence of lactate, the medicine must be used with caution if:
• you suffer from lactic acidosis and in case of alteration of the oxidative processes that prevent the utilization of lactate (shock, hypoxemia);
• you suffer from type 2 diabetes;
• you suffer from an alteration of lactate levels in the blood (e.g. if you suffer from severe liver failure). In this case, RINGER LACTATE S.A.L.F. may only be administered to you if your doctor deems it necessary;
• you suffer from an alteration of blood pH characterized by bicarbonate accumulation called metabolic alkalosis. This medicine should not be administered in the following cases:
• if you suffer from diseases that can cause sodium accumulation, excess fluid or swelling due to fluid accumulation such as one of the following diseases: primary hyperaldosteronism, secondary hyperaldosteronism or preeclampsia.
• if you suffer from conditions that can cause potassium accumulation such as: severe kidney damage, adrenal cortical insufficiency, severe dehydration, or extensive tissue damage, heart failure. In these cases, RINGER LACTATE S.A.L.F. may only be administered to you if your doctor deems it necessary.

During treatment with this medicine, the doctor will periodically check heart function by serial electrocardiograms and the concentration of mineral salts (electrolytes) - in particular sodium as hospital-acquired hyponatremia may develop - fluids, osmolarity and blood pH.
Calcium and urine concentrations must be monitored frequently to avoid hypercalciuria (high levels of calcium in the urine), as it may turn into an increase in calcium levels in the blood (hypercalcemia).
This medicine must be used immediately after opening the container. The solution must be
clear, colorless and free of visible particles and is for single and uninterrupted administration.
Any residue cannot be used.

Children
In children, the safety and efficacy of the medicine have not been determined.
As with other solutions containing calcium, concomitant treatment with ceftriaxone is contraindicated
in newborns (less than 28 days of age) due to the fatal risk of precipitation of ceftriaxone-calcium salt in
the newborn's bloodstream (see section “Possible side effects”).

Other medicines and RINGER LACTATE S.A.L.F.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
This medicine should not be administered to you together with the following medicines:

• cardiac glycosides (digitalis), digoxin and digitoxin, used for heart problems, as concomitant use may increase the risk of irregular heartbeat (arrhythmias) considering that the inotropic effect and toxic effects are synergistic.

This medicine must be administered with caution if you are taking:

• medicines used to lower blood pressure such as: potassium-sparing diuretics, ACE-inhibitors that cause a decrease in aldosterone levels, angiotensin II receptor antagonists and medicines that inhibit the immune system response such as immunosuppressants (such as tacrolimus and cyclosporine), because they can lead to an increase in potassium in the blood (hyperkalemia); in this case, blood potassium levels must be monitored closely;
• anti-inflammatory corticosteroids, which can cause sodium and water retention, resulting in fluid accumulation (edema) and increased blood pressure (hypertension);
• medicines such as thiazide diuretics, used to treat high blood pressure, and vitamin D because they can lead to an increase in calcium levels in the blood (hypercalcemia) due to decreased renal calcium excretion;
• medicines containing magnesium, as they may increase the risk of increased calcium (hypercalcemia) or magnesium (hypermagnesemia) levels, especially in patients with kidney disorders;
• medicines that cause an increase in the effect of vasopressin hormone, for example: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics, chlorpropamide, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin;
• diuretics in general and antiepileptics (e.g. oxcarbazepine) as they may increase the risk of hyponatremia. Due to the alkalinizing action of lactate (bicarbonate formation), the medicine may interfere with the elimination of acidic drugs such as salicylates, barbiturates and lithium (increases renal clearance) and alkaline, such as sympathomimetics (e.g. ephedrine, pseudoephedrine sulfate) and phenfluramine hydrochloride (decreases renal clearance).

Due to the presence of calcium chloride, RINGER LACTATE S.A.L.F. may interact with the following medicines:

• verapamil (and other calcium channel blockers), used to treat high blood pressure, as concomitant use may decrease the antihypertensive effect of verapamil;
• medicines containing magnesium, as they may increase the risk of increased calcium (hypercalcemia) or magnesium (hypermagnesemia) levels, especially in patients with kidney disorders;
• neuromuscular blockers, as calcium salts may reverse the action of non-depolarizing blockers; an increase and prolongation of the action of tubocurarine has also been observed in some cases;
• ceftriaxone (an antibiotic) due to the risk of particle formation.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor for advice before you are given this medicine.
RINGER LACTATE S.A.L.F. should be administered with particular caution in pregnant women
during labor, especially for blood sodium levels, if administered in association with a
medicine called oxytocin.
This medicine should not be used during pregnancy and breastfeeding unless absolutely necessary.

Driving and operating machinery
The medicine does not impair the ability to drive vehicles or operate machinery.

3. How to use RINGER LATTATO S.A.L.F.

This medicine will be prepared by a doctor, pharmacist or nurse and will not be mixed, nor will it be administered simultaneously with injections containing ceftriaxone or other incompatible medicines.
Monitoring of electrolyte balance, serum electrolytes and acid-base balance may be necessary, before and during administration, with particular attention to serum sodium if you suffer from the syndrome of inappropriate antidiuretic hormone secretion (SIADH), or if you are undergoing concomitant therapy with vasopressin agonists, due to the risk of hospital-acquired hyponatremia.
Monitoring of serum sodium is particularly important for hypotonic solutions.
This medicine must be administered directly into a vein (intravenous infusion) by specialized medical personnel using clean and uncontaminated (sterile and apyrogenic) equipment. It must not be injected through other routes of administration (intramuscularly, subcutaneously or into perivascular tissues).
This medicine must be administered only if your kidney function is intact and at a rate not exceeding 10 mEq of potassium per hour.
After administration of the medicine, remain lying down for a short period.
The dose, volume of solution and frequency of administration will depend on age, weight, your state of health and any concomitant treatment with other medicines and your response to treatment with this medicine.
The recommended dose in adults is approximately 20 – 30 ml of solution per kg of body weight per day, which may be increased up to a maximum of 40 ml of solution per kg of body weight per day.
Infusions that are too rapid can cause local pain; the infusion rate must be adjusted according to your needs.
Administration must be stopped if you experience pain or redness at the injection site, as this may be caused by leakage of the medicine from the vein (extravasation of the drug).

Preparation of the medicine:Use the solution immediately after opening the container. The container is for single and uninterrupted administration only and any residual solution cannot be used.
Shake well before administration. Do not use the medicine if the solution is not clear, colourless or if it contains particles.
Ensure that all precautions are taken to maintain sterility before and during intravenous infusion.
During treatment with this medicine, you will be subject to monitoring of blood levels of electrolytes and especially sodium.

If you use more RINGER LATTATO S.A.L.F. than you should
This medicine will be administered by a doctor or specialized personnel; it is unlikely that you will be injected with an excessive dose. However, if you think that you have been administered an excessive dose of RINGER LATTATO S.A.L.F., immediately inform the doctor or go to the nearest hospital.
Following the administration of an excessive dose of this medicine, the following may occur:

• increased levels of potassium in the blood (hyperkalaemia), which can lead to death due to heart damage (cardiac depression, arrhythmias or arrest);
• increased levels of sodium (hypernatraemia) and blood volume in circulation (hypervolaemia). If sodium levels in the blood increase too much, fluid loss from internal organs (dehydration) may occur, particularly from the brain, and fluid accumulation that can affect the cerebral, pulmonary and peripheral circulation, leading to fluid accumulation around the lung (pulmonary oedema) or swelling of the legs and ankles (peripheral oedema);
• increased levels of chlorine which determines the reduction of the pH of the blood (acidosis) due to the reduction of the concentration of bicarbonate ions;
• increased levels of calcium in the blood (hypercalcaemia) with consequent thirst, nausea, vomiting, constipation, increased urine production (polyuria), abdominal pain, muscle weakness, mental disorders and, in severe cases, even heart problems (cardiac arrhythmia) and coma.

If you have any doubts about the use of RINGER LATTATO S.A.L.F., consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur, especially in case of inadequate administration or
too fast administration (See section “Warnings and precautions”):

Not known(frequency cannot be estimated from available data):
Gastrointestinal disorders:

• discomfort and irritation to the stomach and intestines (gastrointestinal), nausea, vomiting, diarrhoea, abdominal pain, constipation, thirst, reduced salivation, metallic taste, chalky taste; Nervous system disorders:
• muscle and nerve disorders (neuromuscular), muscle rigidity, altered sensitivity of the limbs (paresthesia), loss of muscle tone (flaccid paralysis), weakness, mental confusion, headache, dizziness, restlessness, irritability, convulsions, coma, death, acute hyponatremic encephalopathy*; Psychiatric disorders:
• drowsiness, confused states, mental disorders; Cardiac disorders:
• irregular heartbeat such as arrhythmias, tachycardia, bradycardia, conduction disturbances, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, syncope, ventricular fibrillation, cardiac arrest; Vascular disorders:
• reduction or increase in blood pressure (hypotension, hypertension), swelling of the limbs (peripheral edema), vasodilation, flushing; Disorders of water and electrolyte balance:
• increased levels of sodium (hypernatremia), chlorine (hyperchloremia) and volume (hypovolemia) in the blood; Respiratory, thoracic and mediastinal disorders:
• difficulty breathing (dyspnea, respiratory arrest);
• accumulation of fluid in the lungs (pulmonary edema) and air around the lung (pneumothorax); Eye disorders:
• reduced tear production; Renal and urinary disorders:
• kidney problems (renal failure), increased urine production (polyuria); Metabolism and nutrition disorders:
• increased levels of calcium in the blood (hypercalcemia);
• Burnett's syndrome (also called milk-alkali syndrome), a disease caused by excessive intake of milk or alkaline compounds, characterized by symptoms such as nausea, vomiting, headache, muscle weakness;
• hospital-acquired hyponatremia*; Musculoskeletal and connective tissue disorders:
• muscle weakness; Systemic disorders and conditions related to the site of administration:
• fever, infection and inflammation at the infusion site, pain or local reaction, redness, rash, burning, itching, swelling localized at the infusion site, circulatory problems due to blood clot formation in the veins (thrombosis), inflammation of the veins at the infusion site (phlebitis), leakage of the medicine into the tissues around the injection site (extravasation), tissue damage and death (tissue necrosis), abscess formation and formation of calcium deposits on the skin (cutaneous calcification); Immune system disorders:
• Hypersensitivity reactions to infusion, including anaphylactic/anaphylactoid reactions; Calcium-ceftriaxone salt precipitation:
• kidney problems caused by calcium-ceftriaxone deposits. Pain may occur when urinating, or the amount of urine produced may decrease.

* Hospital-acquired hyponatremia can cause irreversible brain damage and death due to the
development of acute hyponatremic encephalopathy.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the address http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store RINGER LATTATO S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What RINGER LATTATO S.A.L.F. contains

• The active ingredients are: sodium chloride, potassium chloride, calcium chloride dihydrate, sodium lactate solution 60%. 1000 ml of solution contains 6.0 g of sodium chloride, 0.4 g of potassium chloride, 0.27 g of calcium chloride dihydrate, 5.46 g of sodium lactate solution 60%. Each liter of solution contains 132 mEq of sodium, 5 mEq of potassium, 4 mEq of calcium, 112 mEq of chloride and 29 mEq of lactate. (pH: 5.5 - 7.0).
• The other component is water for injections.

Description of the appearance of RINGER LATTATO S.A.L.F. and contents of the pack
Pack containing a glass vial of 100 ml or 500 ml of infusion solution;
Pack containing a PP vial of 500 ml of infusion solution;
Pack containing a PVC bag of 500 ml, 1000 ml or 3000 ml of infusion solution;
Pack of 15 PVC bags of 500 ml of infusion solution;
Pack of 10 PVC bags of 1000 ml of infusion solution.

Marketing Authorisation Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 – Cenate Sotto (BG) – Italy.
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The following information is intended exclusively for doctors or healthcare professionals

RINGER LATTATO S.A.L.F. infusion solution
Treatment of overdose
Immediately discontinue the infusion and institute corrective therapy to reduce plasma levels of
ions that are in excess and restore, if necessary, acid-base balance (see Precautions for
use).
The patient should be kept under observation to assess the appearance of any signs and symptoms
related to the administered drug, ensuring the patient receives appropriate symptomatic and supportive measures as
needed.
In case of high natremia, loop diuretics may be used.
In case of hyperkalemia, glucose (with or without
insulin) or sodium bicarbonate may be administered by intravenous infusion.
In case of modest calcium chloride overdose, treatment involves immediate suspension
of the infusion and any other drug containing calcium. In case of severe overdose (plasma concentrations
>2.9 mmol/l), the following measures should be taken:

• rehydration by administering a 0.9% sodium chloride solution;
• use of non-thiazide diuretics to promote calcium elimination;
• monitoring of plasma potassium and calcium levels with immediate restoration of levels to normal values;
• monitoring of cardiac function, use of beta-blockers to reduce the risk of cardiac arrhythmia;
• possible recourse to hemodialysis. Elevated plasma electrolyte levels may require dialysis.

Incompatibilities
If used to dilute drugs, consult the pharmacist if available before introducing the additive drugs;
however, consider the characteristics of the products to be introduced; use aseptic techniques.
Due to the presence of calcium chloride, the medicinal product is incompatible with:

• magnesium sulfate: formation of a precipitate;
• medicines containing phosphate: formation of a calcium phosphate precipitate;
• medicines containing carbonate: formation of a calcium carbonate precipitate;
• medicines containing tartrate: formation of a calcium tartrate precipitate. Incompatibilities of calcium chloride have been reported with:
• aminophylline: due to precipitate formation;
• amphotericin B: due to the development of numbness;
• cefamandole: due to the presence of sodium carbonate in the preparation of cefamandole;
• cephalothin: due to physical incompatibility;
• cefradine: due to the presence of sodium carbonate in the preparation of cefradine;
• chlorphenamine: due to physical incompatibility;
• dobutamine: due to the development of numbness;
• fat emulsion: due to the presence of flocculate;
• sodium heparin;
• indometacin: due to precipitate formation;
• nitrofurantoin sodium;
• promethazine: due to precipitate formation:
• propofol: due to precipitate formation;
• streptomycin: as calcium may inhibit the activity of streptomycin;
• tetracyclines: calcium salts can complex tetracyclines;
• Calcium salts can form complexes with many drugs and this can determine the formation of precipitates.
• sodium ceftriaxone: due to precipitate formation, therefore the administration of calcium solution should not occur within 48 hours of the administration of ceftriaxone.

Interactions
Medicines that can increase the risk of hospital-acquired hyponatremia, following
treatment not adequately balanced with intravenous solutions, are:

• medicines stimulating vasopressin release, for example: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy- N-methamphetamine, ifosfamide, antipsychotics, narcotics
• medicines that potentiate the action of vasopressin, for example: chlorpropamide, NSAIDs, cyclophosphamide
• vasopressin analogues: desmopressin, oxytocin, vasopressin, terlipressin Other medicines that increase the risk of hyponatremia also include diuretics in general and antiepileptics such as oxcarbazepine.

Warnings and precautions
Monitoring of serum sodium is particularly important for hypotonic solutions.
Ringer Lactate S.A.L.F. can become extremely hypotonic after administration.
Patients with non-osmotic vasopressin release (e.g. in the acute phase of the disease, pain, post-
operative stress, infections, burns and diseases of the central nervous system), patients with heart disease, liver disease and
kidney disease and patients treated with vasopressin agonists, are particularly at risk of acute hyponatremia
following infusion of hypotonic solutions. Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with
cerebral edema are particularly at risk of severe, irreversible and life-threatening brain injury.
Children, women of childbearing potential and patients with reduced cerebral compliance (e.g. meningitis, intracranial hemorrhage and cerebral contusion) are particularly at risk of severe and life-threatening cerebral edema caused by acute hyponatremia.

Pregnancy
Ringer Lactate S.A.L.F. should be administered with particular caution in pregnant women during
labor, especially if administered in association with oxytocin, due to the risk of hyponatremia.

For further information consult the Summary of Product Characteristics.