ELETTROLITICA DI REINTEGRATSIONE KON SODIO LUKONATO BAXTER 100 ML Инфузионный раствор

Содержание инструкции

1. ELECTROLYTIC REINTEGRATION WITH SODIUM GLUCONATE BAXTER
   1. What is Electrolytic Reintegration with Sodium Gluconate Baxter and what is it used for
   2. What you need to know before you are given Elettrolitica di Reintegrazione
   3. How Elettrolitica di Reintegrazione con Sodio Gluconato will be administered to you
   4. Possible side effects
   5. How to store Elettrolitica di Reintegrazione con Sodio Gluconato Baxter
   6. Contents of the pack and other information

ELECTROLYTIC REINTEGRATION WITH SODIUM GLUCONATE BAXTER

Solution for infusion
Sodium chloride, Potassium chloride, Magnesium chloride, Sodium acetate, Sodium gluconate

EQUIVALENT MEDICINAL PRODUCT
Read this leaflet carefully before this medicine is administered to you
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, pharmacist or nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What is Electrolytic Reintegration with Sodium Gluconate Baxter and what it is used for
• 2. What you need to know before Electrolytic Reintegration with Sodium Gluconate Baxter is administered to you
• 3. How Electrolytic Reintegration with Sodium Gluconate Baxter will be administered to you
• 4. Possible side effects
• 5. How to store Electrolytic Reintegration with Sodium Gluconate Baxter
• 6. Contents of the pack and other information

1. What is Electrolytic Reintegration with Sodium Gluconate Baxter and what is it used for

Electrolytic Reintegration with Sodium Gluconate Baxter contains electrolytes, substances
naturally present in the blood that are useful for the functioning of the body.
Electrolytic Reintegration with Sodium Gluconate Baxter is indicated in adultsfor
reintegrating fluids and electrolytes following their loss and for treating mild levels of acids in
the blood (metabolic acidosis).

2. What you need to know before you are given Elettrolitica di Reintegrazione

with Sodium Gluconate Baxter
You will not be given Elettrolitica di Reintegrazione with Sodium Gluconate Baxter

• if you are allergic to one or more of the electrolytes or to any of the components of this medicine (listed in paragraph 6).
• if you suffer from high sodium concentrations in the blood (hypernatremia);
• if you suffer from high concentrations of water and salts in the blood;
• if you suffer from high potassium concentrations in the blood (hyperkalemia) or if your body retains potassium;
• if you suffer from a severe liver disease (inability to metabolize the acetate ion);
• if you suffer from a severe kidney disease;
• if you suffer from a kidney disease andproduce little urine;
• if you suffer from a severe heart disease; 1 of 12
• if you take less than 16 breaths per minute;
• if you have low levels of acids in the blood (respiratory and metabolic alkalosis);
• if you have an excess of coagulation factors that promote the formation of thrombi (hypercoagulability);
• if you are taking medicines to treat heart disease (cardioactive glycosides - see paragraph Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter);
• if you have lost a lot of fluids;
• if you are in a coma;
• if you suffer from a disease of the adrenal glands, glands located above the kidneys, and are not taking medicines to treat it (untreated Addison's disease);
• if you suffer from cramps after physical activity.

Warnings and precautions
Consult your doctor or nurse before you are given Elettrolitica di
Reintegrazione with Sodium Gluconate Baxter.
Tell your doctor:

• if you suffer from a heart disease (congestive heart failure),
• if you suffer from a severe kidney disease and fluid and salt retention causing swelling,
• if you are taking medicines to treat heart disease or inflammation (see paragraph Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter),
• if you suffer from high blood pressure,
• if you have a weak heart (heart failure), especially if you are taking medicines based on digitalis (see paragraph Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter),
• if you suffer from swelling of the ankles, hands and feet (peripheral edema),
• if you suffer from fluid accumulation around the lungs,
• if you suffer from a kidney disease,
• if you are pregnant and have high blood pressure (pre-eclampsia),
• if you suffer from a disease of the adrenal glands,
• if you or someone in your family suffers from a disease that causes paralysis (familial periodic paralysis),
• if you or someone in your family suffers from a disease that prevents you from relaxing your muscles after contracting them (congenital myotonia),
• if you have recently undergone surgery,
• if you suffer from a severe muscle disease that can lead to paralysis (myasthenia gravis),
• if you are taking medicines that inhibit the action of the central nervous system and neuromuscular blockers (see paragraph Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter),
• if you suffer from a liver disease, even mild or moderate,
• if you suffer from high levels of magnesium in the blood (hypermagnesemia) or are taking magnesium (see paragraph Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter),
• if you suffer from low levels of acids in the blood (alkalosis),
• if you suffer from an increase in blood circulation or have received a lot of fluids,
• if you suffer from low levels of calcium in the blood,
• if you suffer from high levels of potassium in the blood, 2 of 12
• if you have lost a lot of fluids,
• if you have a burn,
• if you are in a condition that can cause high levels of vasopressin, a hormone that regulates fluids in your body. You may have too much vasopressin in your body because for example:
• you have a sudden and serious illness
• you are in pain
• you have undergone surgery
• you have infections, burns or brain diseases
• you have diseases related to your heart, liver, kidneys or central nervous system because you are taking certain drugs (see also below “Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter”)
• This can increase the risk of low sodium levels in your blood and can lead to headache, nausea, seizures, lethargy, coma, cerebral edema. Cerebral edema increases the risk of serious, irreversible and life-threatening brain injury. People who are at higher risk of cerebral edema are:
• children
• women (especially of childbearing age) people who have problems with their brain fluid levels, for example, due to meningitis, intracranial hemorrhage or brain damage

Elettrolitica di Reintegrazione with Sodium Gluconate Baxter may interfere with the results of
blood tests for the detection of the fungus Aspergillus. Tell your doctor or laboratory technician that you are taking Elettrolitica di Reintegrazione with Sodium Gluconate Baxter

Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter
Tell your doctor or nurse if you are taking, have recently taken or may
take any other medicine.
Some drugs act on the hormone vasopressin. These may include:

• antidiabetic drugs (chlorpropamide)
• cholesterol drugs (clofibrate)
• anticonvulsant drugs (carbamazepine)
• some cancer drugs (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• 3,4-methylenedioxy-N-methamphetamine
• antipsychotics
• narcotics
• painkillers and/or anti-inflammatory drugs (also known as NSAIDs) drugs that reproduce 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.

In particular, tell your doctor if you are taking one of the following medicines because the administration together with Elettrolitica di Reintegrazione with Sodium
Gluconate Baxter is not recommended:

• medicines to treat high blood pressure such as potassium-sparing diuretics (amiloride, spironolactone, triamterene), ACE inhibitors (Angiotensin Converting Enzyme), and angiotensin II receptor antagonists
• tacrolimus or cyclosporine, if you have undergone an organ transplant 3 of 12

The doctor will perform blood tests because these medicines can increase
potassium levels in the blood.
Also tell your doctor if you are taking:

• corticosteroids and salicylates, medicines to treat inflammation (see paragraph Warnings and precautions)
• barbiturates, narcotics or other hypnotics, medicines to treat mental disorders or to induce sleep
• drugs that depress the central nervous system
• cardioactive glycosides (digitalis), digoxin and digitoxin, quinidine, medicines to treat heart disease (see paragraph 2. You will not be given Elettrolitica di Reintegrazione with Sodium Gluconate Baxter),
• calcium antagonists (isradipine, felodipine, nicardipine and nifedipine), medicines to treat high blood pressure
• neuromuscular blockers or systemic anesthetics such as rocuronium, medicines administered during operations (see paragraph Warnings and precautions),
• aminoglycoside antibiotics, medicines to treat infections
• eltrombopag, a medicine used to help increase the number of platelets in the blood.
• labetolol, a medicine to treat heart disease (see paragraph Warnings and precautions). If you take Elettrolitica di Reintegrazione with Sodium Gluconate Baxter and labetolol you may experience shortness of breath, dizziness or fainting
• lithium, a medicine to treat mental disorders
• sympathomimetics (e.g. ephedrine, pseudoephedrine), medicines that stimulate the nerves
• destroamphetamine (desamphetamine) sulfate, a medicine to treat prolonged drowsiness.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Elettrolitica di Reintegrazione with Sodium Gluconate Baxter should be given with
particular caution in pregnant women during labor, especially for serum sodium, if administered in association with oxytocin.
Elettrolitica di Reintegrazione with Sodium Gluconate Baxter will be given to you
during pregnancy or breastfeeding only if absolutely necessary.

Avoidthe use of magnesium 2 hours before delivery. If magnesium chloride is administered
(especially for more than 24 hours before delivery) to control seizures in mothers affected by
pregnancy toxemia, it can cause magnesium toxicity in newborns, including neuromuscular and respiratory depression.

Driving and using machines
The medicine does not impair the ability to drive vehicles or use machinery.

3. How Elettrolitica di Reintegrazione con Sodio Gluconato will be administered to you

Baxter
This medicine will be administered to you intravenously, always following the doctor's or nurse's instructions exactly. If you have any doubts, consult your doctor.
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The dose will be established by the doctor based on your age, weight and state of health and treatments with other medicines in progress.

If you are given more Elettrolitica di Reintegrazione con Sodio Gluconato
Baxter than you should
It is very unlikely that you will be given more Elettrolitica di Reintegrazione con Sodio Gluconato Baxter than you should, as your doctor or nurse will monitor you during treatment.

Symptoms
High concentrations in the blood of the substances contained in Elettrolitica di Reintegrazione con Sodio Gluconato Baxter could cause:

• death due to decreased activity, heart rhythm disturbances or cardiac arrest;
• increased levels of sodium and decreased fluids in the blood, which could cause dehydration of internal organs, and fluid accumulation in organs (e.g. brain and lungs);
• flushing, sweating, low blood pressure, paralysis, decreased body temperature, inability of the heart to pump enough blood to meet the body's needs, decreased heart and central nervous system activity that can lead to respiratory arrest;
• decreased acids in the blood, which can cause decreased levels of potassium, calcium and magnesium in the blood TreatmentThe doctor will immediately stop the infusion and institute corrective therapy to reduce the levels of substances that are in excess in the blood. You may also undergo blood filtration (dialysis).

If you stop taking Elettrolitica di Reintegrazione con Sodio Gluconato
Baxter
The doctor will decide when to stop the treatment.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience the following side effects during the administration of Elettrolitica di Reintegrazione con Sodio Gluconato Baxter,
the doctor will IMMEDIATELYstop the administration at the first sign of alarm, and will administer, when
possible, appropriate therapy to treat these symptoms, which can lead to death:

• allergic reactions, which, in some cases, may progress to become severe allergic reactions (anaphylaxis). Allergic reactions may include the following symptoms:
• very fast heart rate (tachycardia)
• feeling of perceiving the heartbeat (palpitations)
• chest pain and discomfort
• difficulty breathing (dyspnea), increased breathing rate,
• redness, warmth, weakness,
• feeling of abnormality, goosebumps (piloerection),
• swelling of the ankles (peripheral edema), fever, hives
• lowering of blood pressure (hypotension), shortness of breath, cold sweats, chills, high levels of potassium in the blood (hyperkalemia)
• pain or redness at the injection site, as this may indicate leakage of the medicine from blood vessels. 5 of 12

In addition, the doctor may ask you to undergo periodic checks and laboratory tests.
Below are the side effects of Elettrolitica di Reintegrazione con Sodio
Gluconato Baxter. Sufficient data are not available to establish the frequency of individual
effects listed:

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* Hospital-acquired hyponatremia can cause irreversible brain damage and death, due to the
development of acute hyponatremic encephalopathy, with unknown frequency (see also paragraph
"Warnings and Precautions")

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
contact your doctor, pharmacist or nurse. You can also report side effects directly via the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Elettrolitica di Reintegrazione con Sodio Gluconato Baxter

Store in the original packaging and keep the container tightly closed.
Do not refrigerate or freeze.
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Keep this medicine out of 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.
Do not use this medicine if you notice any leakage.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Elettrolitica di Reintegrazione con Sodio Gluconato Baxter contains

• The active ingredients are: sodium chloride, potassium chloride, magnesium chloride, sodium acetate, sodium gluconate.
• The other ingredients are: water for injections; hydrochloric acid

Description of the appearance of Elettrolitica di Reintegrazione con Sodio Gluconato Baxter and
contents of the pack
Elettrolitica di Reintegrazione con Sodio Gluconato Baxter is presented as a solution
It is available in the following packs:
Glass bottles 100 ml Pack of 1 unit
Glass bottles 250 ml Pack of 1 unit
Glass bottles 500 ml Pack of 20 units
ClearFlex flexible bags 100 ml Pack of 1 unit
ClearFlex flexible bags 250 ml Pack of 1 unit
ClearFlex and Viaflo flexible bags 500 ml Pack of 20 units
ClearFlex flexible bags 1000 ml Pack of 1 unit
Viaflo flexible bags 500 ml Pack of 24 units
Viaflo flexible bags 1000 ml Pack of 10 units
Viaflo flexible bags 1000 ml Pack of 12 units
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
BAXTER S.p.A.
Piazzale dell’Industria 20 – 00144 Rome
Manufacturer
Bottles and ClearFlex bags:
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BIEFFE MEDITAL S.p.A. Via Nuova Provinciale - 23034 Grosotto (So)
The ClearFlex and Viaflo bags may be produced by:
BIEFFE MEDITAL S.A. Ctra de Biescas - 22666 Sabiñánigo (Spain)
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The following information is intended only for doctors or healthcare professionals:

Dosage, method and duration of administration
It may be necessary to monitor electrolyte balance, serum electrolytes and
acid-base balance before and during administration, with particular attention to
serum sodium in patients with increased non-osmotic vasopressin release (syndrome
of inappropriate antidiuretic hormone secretion, SIADH) and in patients undergoing
concomitant therapy with vasopressin agonists, due to the risk of hospital-acquired
hyponatremia (see sections Special warnings, Interactions and Undesirable effects).
Monitoring of serum sodium is particularly important for hypotonic solutions.
Osmolarity of Elettrolitica di Reintegrazione con Sodio Gluconato Baxter: mOsm/l 296
The infusion rate and volume depend on age, weight, clinical condition
(e.g. burns, surgery, head injuries, infections) and concomitant therapy must be determined by a doctor experienced in paediatric therapy with intravenous solutions (see sections Special warnings and Undesirable effects).
The solution is isotonic with blood and must be administered by intravenous infusion
with caution and at a controlled infusion rate.
Use immediately after opening the container. The solution must be clear, colourless or
slightly straw-yellow and free from visible particles. It is for single use and
uninterrupted administration and any remaining solution must not be used.

Shake well before preparation and before use.
Administer only with intact renal function and at an infusion rate not exceeding
10 mEq potassium/hour.

Adults
Generally the dose is approximately 2 litres/day, administered at an infusion rate of approximately
2 litres/hour.

Children
In children, the safety and efficacy of the medicine have not been established.
Do not inject intramuscularly, subcutaneously or into perivascular tissues.
Administration should be stopped if the patient experiences pain or redness at the injection site, as this may indicate extravasation of the drug. Infusions that are too rapid
can cause local pain and the infusion rate must be adjusted according to
tolerance.
It is recommended that the patient remain lying down for a short period after
administration.
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When choosing the type of solution and the volume/infusion rate for an elderly patient,
consider that elderly patients are generally more prone to various
problems such as cardiac, renal, hepatic and also consider concomitant pharmacological therapies.
Do not connect flexible plastic containers in series to avoid gas embolism due to
possible residual air contained in the primary container.
Pressurizing intravenous solutions contained in flexible plastic containers to
increase flow rates can cause gas embolism if the residual air in the container
is not completely removed before administration.
The use of an intravenous administration set with the vent in the open position can
cause gas embolism. Intravenous administration sets with the vent in the open
position must not be used with flexible plastic containers.

Warnings
Infusion of large volumes should be used with specific monitoring
in patients with heart or lung failure and in patients with non-osmotic release of
vasopressin (including SIADH), due to the risk of hospital-acquired hyponatremia (see
below).
Hyponatremia
Patients with non-osmotic release of vasopressin (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 (see section Interactions) 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 haemorrhage, contusion and cerebral edema) are particularly at risk of
severe and life-threatening cerebral edema caused by acute hyponatremia.
Due to the presence of potassium, administration should be guided by serial electrocardiograms; serum potassium is not indicative of intracellular potassium concentrations.
High plasma potassium concentrations can cause death from cardiac depression,
arrhythmias or arrest. To avoid potassium poisoning, the infusion must be slow.
During the infusion of the medicine, monitoring of the electrocardiographic tracing is essential and it is good practice to monitor fluid balance, electrolytes,
plasma osmolarity, blood pressure, acid-base balance, osteotendinous reflexes,
the latter in order to monitor for possible respiratory paralysis.
Serum magnesium levels must be carefully monitored during therapy to ensure that these do not exceed.
Do not administer to patients in a coma.
The solution is not indicated for the treatment of hypochloremic-hypokaliemic alkalosis.
Although the solution has a potassium concentration similar to the concentration in
plasma, it is not sufficient to produce useful effects in case of severe potassium deficiency;
therefore it should not be used for the correction of severe potassium deficiency.
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The solution is not indicated for the primary treatment of severe metabolic acidosis or for
the treatment of hypomagnesemia.
Infusion/hypersensitivity reactions have been reported, including anaphylactoid reactions.
The infusion must be stopped immediately if signs or symptoms of a
suspected hypersensitivity reaction occur. Appropriate therapeutic countermeasures must be taken as clinically indicated.
Depending on the volume and infusion rate, intravenous administration of
the solution can cause:

• fluid and/or solute overload leading to hyperhydration/hypervolemia and, for example, congestive states, including pulmonary congestion and edema
• clinically relevant electrolyte disturbances and acid-base imbalance Periodic clinical assessment and laboratory tests may be necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or when the patient's condition or infusion rate requires such tests.

Incompatibilities with Elettrolitica di Reintegrazione con Sodio Gluconato Baxter:
Due to the presence of magnesium, the medicine is incompatible with solutions containing alcohol (at
high concentrations), heavy metals, carbonates and bicarbonates, sodium hydrocortisone, succinates,
phosphates, polymyxin B sulfate, procaine hydrochloride, calcium salicylate, clindamycin phosphate,
tartrates, as precipitates may form.
Potential incompatibility is often influenced by modification of the concentration
of the reagents and the pH of the solutions.
Use immediately after opening the container. The container is for single and uninterrupted
administration and any remaining solution must not be used.
Shake well before administration. Do not use the medicine if the solution does not
appear clear, colourless or slightly straw-yellow or if it contains particles.
Take all usual precautions to maintain sterility before and during intravenous infusion.
If used to dilute drugs, consult the pharmacist if available before introducing
the drug additives; however, consider the characteristics of the products to be introduced; use
aseptic techniques. Mix the solution thoroughly when drug additives are introduced. Do not store solutions containing additives.
As with all parenteral solutions, the compatibility of drug additives with the solution
must be assessed before addition. Before adding a substance or drug, verify that it is soluble and/or stable in water and that the pH range is appropriate. After
addition, check for any colour change and/or the appearance of precipitates, insoluble complexes or crystals.
Drug additives that are known to be incompatible or for which it has been established that they are
incompatible must not be used.

Overdosage

Symptoms
High plasma potassium concentrations can cause death from cardiac depression,
arrhythmias or arrest.
Administration of excessive doses of sodium chloride can lead, depending on
the patient's clinical condition, to hypernatremia and/or hypervolemia. Hypernatremia and
excessive sodium retention where there is impaired renal sodium excretion determines dehydration of internal organs, in particular the brain, and the accumulation of
extracellular fluid with edema that can affect the cerebral, pulmonary and
peripheral circulation with the appearance of pulmonary and peripheral edema.
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In case of administration of high doses of magnesium, the following symptoms of intoxication may occur: flushing, sweating, hypotension, flaccid paralysis, hypothermia,
circulatory collapse, cardiac and central nervous system depression which may evolve into
respiratory paralysis. Magnesium intoxication manifests with a peak in blood pressure and respiratory paralysis. The disappearance of the patellar reflex is a useful clinical sign for
identifying the onset of intoxication.
Excessive administration of the solution can cause metabolic alkalosis which may be
accompanied by hypokalaemia as well as a decrease in ionized serum calcium and magnesium.
Excessive volume of solution can cause fluid and sodium overload with risk of
edema (peripheral and/or pulmonary), especially when renal sodium excretion is impaired.
Excessive administration of potassium can cause the development of hyperkalaemia,
especially in patients with severe renal impairment.
Excessive administration of magnesium can cause hypermagnesaemia.
When an overdose is detected, any addition to the solution should also be considered.
The effects of an overdose may require immediate medical attention and immediate
treatment.

Treatment
Immediately stop the infusion and institute corrective therapy to reduce plasma levels
of excess ions and restore, if necessary, acid-base balance (see Warnings and precautions).
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 can be used.
In case of hyperkalaemia, glucose (with or without insulin) or sodium bicarbonate can be administered intravenously.
In case of magnesium intoxication manifesting with respiratory paralysis, artificial respiration is necessary.
To counteract the effects of hypermagnesaemia, calcium must be administered intravenously (10-20 ml of a 5% solution). The administration of 0.5-1 mg of physostigmine subcutaneously may be helpful.
High levels of plasma electrolytes may require dialysis.
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