ISOLYTE 2000 ML Roztwór infuzyjny

Treść ulotki

1. ISOLYTE solution for infusion
   1. What is ISOLYTE and what is it used for
   2. What you need to know before you are given ISOLYTE
   3. How ISOLYTE is administered
   4. Possible side effects
   5. How ISOLYTE is stored
   6. Contents of the pack and other information

ISOLYTE solution for infusion

Electrolytes associated with carbohydrates

Read this leaflet carefully before you are given 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 any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What ISOLYTE is and what it is used for
• 2. What you need to know before ISOLYTE is given to you
• 3. How ISOLYTE is given
• 4. Possible side effects
• 5. How ISOLYTE is stored
• 6. Contents of the pack and other information

1. What is ISOLYTE and what is it used for

Isolyte is an infusion solution containing electrolytes associated with carbohydrates.
Isolyte is indicated to treat losses of extracellular fluids and electrolytes, when it is necessary:

• to correct mild or moderate, but not severe, states of metabolic acidosis, a condition in which there is an increase in blood acidity,
• to ensure a caloric intake for the body.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before you are given ISOLYTE

You will not be given ISOLYTE

• If you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6).
• If you have a higher than normal amount of sugar in your blood (hyperglycemia)
• If you have high potassium concentrations in your blood (hyperpotassemia) or have a decreased ability to eliminate potassium from the body (potassium retention).
• If you have high calcium concentrations in your blood (hypercalcemia).
• If you suffer from a severe liver disease (severe hepatic insufficiency).
• If you have high levels of acetate or an impairment in its utilization.
• If you have low concentrations of acids in your blood (metabolic and respiratory alkalosis).
• If you are receiving a blood transfusion.
• If you have a heart malformation (congenital heart defect).
• If you suffer from a severe kidney disease (severe renal insufficiency).
• If you suffer from fluid retention causing swelling (edema) due to sodium retention .

If the patient is a newborn (≥28 days of age), Isolyte will not be administered concurrently with
ceftriaxone (an antibiotic), even in case of using separate infusion lines (see Other
medicines and ISOLYTE).

Warnings and precautions
Talk to your doctor or nurse before you are given ISOLYTE:

• If you have kidney problems (severe renal insufficiency, reduced renal function), as the administration of this solution may cause sodium or potassium retention.
• If you have heart problems (congestive heart failure).
• If you have fluid accumulation (edema with saline retention).
• If you suffer from diabetes mellitus; your doctor will monitor your blood sugar levels for the corrections to the therapy they deem most appropriate.
• if you are taking medicines for the heart (cardiac inotropic drugs) or corticosteroids or corticotropins (see section Other medicines and ISOLYTE).
• If you suffer from low levels of chloride and potassium ions in the blood with an increase in alkalinity in the body (hypochloremia, hypokalemia, alkalosis)
• If you suffer from an allergy to corn or corn-derived products
• If you suffer from high concentrations of magnesium in the blood (hypermagnesemia) or conditions predisposing to it such as severe kidney disease (severe renal insufficiency) or magnesium-based therapy such as for eclampsia (a condition that can affect women during pregnancy).
• If you suffer from muscle weakness (myasthenia gravis)
• If you suffer from an increase in alkalinity in the blood (alkalosis)
• If you suffer from high blood volume (hypervolemia) or are overhydrated
• If you suffer from saline retention, fluid overload or edema
• Any condition that may lead to high potassium levels in the blood (hyperpotassemia) such as:
• Kidney damage
• Adrenocortical insufficiency (this is a disease of the adrenal glands that affects hormones that control substance concentrations in the body)
• Acute dehydration (a loss of water from the body e.g. due to vomiting or diarrhea)
• Extensive tissue damage (which can occur in severe burns)
• Heart disease
• If you suffer from kidney stones or have a history of kidney stones
• If you are in a condition that can cause high concentrations of vasopressin, a hormone that regulates fluids in your body. You may have too much vasopressin in your body for example because:
• you have had a sudden and serious illness
• you are in pain
• you have undergone surgery
• you have an infection, burns or a brain disease
• you have diseases related to the heart, liver, kidneys or the central nervous system
• you are taking certain medications (see the section “Other medicines and Isolyte” This can increase the risk of low sodium levels in the blood and can lead to headache, nausea, seizures, lethargy, coma, brain edema and death. Brain edema increases the risk of death and brain damage. People at high risk of cerebral edema are:
• children
• women (especially of childbearing potential)
• people who have problems with the levels of brain fluids, for example due to meningitis, intracranial bleeding or brain damage

Children
The safety and efficacy of ISOLYTE have not been established in children.

Other medicines and ISOLYTE
Tell your doctor if you are taking, have recently taken or might take any other
medicines such as:

• corticosteroids (medicines used to treat inflammation and allergies),
• corticotropin,
• ceftriaxone (an antibiotic). Ceftriaxone should not be administered concurrently with intravenous solutions containing calcium, including Isolyte, through the same infusion line. Concurrent treatment with ceftriaxone is contraindicated in newborns (≤28 days of age), even in case of using separate infusion lines (risk of precipitation of particles in the newborn's bloodstream, which can lead to death).
• Salicylates: a medicine used to treat inflammation and fever
• Barbiturates, a medicine used to treat seizures or sleep problems
• Lithium, a medicine used to treat certain psychiatric conditions (bipolar disorders)
• Ephedrine, a medicine used to treat low blood pressure or bronchospasm in cases of asthma or bronchitis
• Pseudoephedrine, a medicine used to treat cold and flu symptoms
• Quinidine, a medicine used to treat or prevent irregular heartbeats
• Destroamphetamine (or dexamphetamine) sulfate, a medicine used to treat attention deficit disorders. Some drugs affect the vasopressin hormone. These may include:
• cholesterol medications (clofibrate)
• some cancer medications (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or opioids for strong pain relief
• pain relievers and/or anti-inflammatory drugs (also known as NSAIDs)
• drugs that reproduce or enhance the effect of vasopressin such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat esophageal bleeding) and oxytocin (used to induce labor)
• antiepileptic drugs (carbamazepine and oxcarbazepine)
• diuretics (drugs to increase diuresis) .

The following interactions should be considered if there is an increase in blood levels of:

• sodium
• Corticosteroids and carbenoxolone, as they may promote sodium and water retention (with edema and high blood pressure).
• potassium These medicines can increase potassium levels in the blood, especially if you have kidney disease:
• suxamethonium, a medicine used for muscle relaxation;
• potassium-sparing diuretics (amiloride, spironolactone, triamterene, alone or in combination);
• tacrolimus, cyclosporine, medicines used after an organ transplant to prevent rejection;
• ACE inhibitors, medicines used to treat high blood pressure;
• heparin, a medicine used to prevent blood clots.
• calcium
• digitalis glycosides, medicines used to treat heart rhythm disorders, especially if you have high calcium levels in the blood (hypercalcemia).
• vitamin D, a medicine used to promote bone development.

Pregnancy, breastfeeding and fertility
ISOLYTE should be administered with particular caution in pregnant women during
labor, especially if administered in association with oxytocin, due to the risk of
hyponatremia (see paragraphs “ Warnings and precautions”and “Other medicines and ISOLYTE”)
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before you are given this medicine.
The safety of this product in pregnant women has not been established.
During pregnancy and breastfeeding Isolyte will be given to you only if necessary.

3. How ISOLYTE is administered

Isolyte will be prepared by a doctor, pharmacist or nurse and will not be mixed, nor will it be administered at the same time as injections containing ceftriaxone.
ISOLYTE is generally administered by a doctor or nurse via an intravenous drip (intravenous infusion).
Before and during the infusion, the doctor will monitor:

• potassium levels
• the amount of fluids in your body
• the acidity of blood and urine
• the amount of electrolytes in your body (in particular sodium, in patients with high levels of vasopressin, or who are taking other drugs that increase the effect of vasopressin).

If you have any doubts, consult your doctor.
The doctor will determine the correct dose of ISOLYTE for you, based on your age, weight and state of health.

If you are given more ISOLYTE than you should
It is very unlikely that you will be given more infusion solution than necessary because your doctor or nurse will monitor you during treatment.
If you are accidentally given more Isolyte than the prescribed dose, the doctor will stop the administration and monitor you carefully.
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 everybody gets them.
Rarely, serious, and in some cases fatal, side effects have been reported in premature and full-term infants (under 28 days of age) who had been treated with ceftriaxone and calcium intravenously.
Cases of renal precipitation have been reported, mainly in children over 3 years of age treated with high daily doses. The risk of precipitate formation increases in patients who are bedridden or
dehydrated.
You may experience pain when urinating, or the amount of urine produced may be reduced.
Calcium-ceftriaxone salt precipitation has been observed in the gallbladder, mainly in patients
treated with doses higher than the standard recommended dose, which may be accompanied by
pain, nausea and vomiting.
The possible side effects are listed below according to the following frequency:
Not known (the frequency cannot be estimated on the basis of the available data)

• severe allergic reactions that can cause difficulty breathing or dizziness (anaphylactoid reactions), urticaria
• high blood glucose concentration (hyperglycemia)
• high blood potassium concentration (hyperpotassemia)
• a fast heartbeat (tachycardia) or fast and irregular heartbeat (palpitations)
• low blood pressure (hypotension) redness of the eyes (hyperemia)
• shortness of breath (dyspnea) panting
• goosebumps (piloerection) cold sweats
• reactions due to the route of administration: infection at the injection site, inflammation and/or blockage of the vein at the injection site (phlebitis, thrombophlebitis, venous thrombosis), fever, chills, redness, burning sensation, chest pain, malaise, weakness, feeling strange, fluid accumulation under the skin, especially in the ankles (peripheral edema), localized pain at the injection site,
• increased respiratory rate
• Hospital-acquired hyponatremia (low sodium levels in the blood that can be acquired during hospitalization)*
• Hyponatremic encephalopathy (brain disorders)*

*Acute hyponatremia can cause irreversible brain damage and death, due to the development of cerebral edema/swelling (see also section “Warnings and Precautions”)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system at 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 ISOLYTE is stored

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the bag after Scad.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the 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 ISOLYTE contains

• The active ingredients per 1000 ml of solution are:

Approximately mEq/liter
Sodium 50.0
Potassium 22.5
Magnesium 5.0
Calcium 2.5
Chloride 50.0
Acetate 38.0
Approximately mOsm/l 450
pH approximately 5
Kcal/l 200 (837 kJ/l)

• The other components are water for injections, acetic acid.

Description of the appearance of ISOLYTE and contents of the pack
ISOLYTE comes as a solution contained in a sealed Clearflex plastic bag and
inserted into a plastic pouch.
The bag contains 2000 ml of solution.
It is available in packs of 6 bags per box.

Marketing authorisation holder and manufacturer
Baxter S.p.A. - Piazzale dell’Industria 20- 00144 Rome

Manufacturer
Bieffe Medital S.p.A. - Via Nuova Provinciale - 23034 Grosotto (So)

-------------------------------------------------------------------------------------------------------------------------

• - The following information is intended exclusively for doctors or healthcare professionals:

Precautions for use
Intravenous administration of this solution may cause fluid or
electrolyte overload and lead to dilution of serum electrolyte concentrations, hyperhydration, congestive states or pulmonary edema.
ISOLYTE should be administered with particular caution in patients with

• known allergy to corn or corn-derived products.
• hypermagnesemia or conditions predisposing to hypermagnesemia including but not limited to severe renal impairment or magnesium therapy such as for eclampsia;
• myasthenia gravis
• alkalosis or risk of alkalosis, excessive administration of ISOLYTE may cause metabolic alkalosis.
• hypervolemia or overhydration
• sodium retention, excess fluid and edema.
• hyperpotassemia or conditions predisposing to hyperpotassemia (such as severe renal failure or adrenal insufficiency, acute dehydration, extensive tissue damage or burns) and in patients with heart disease.
• calcium renal stones or a history of calcium renal stones.
• congestive heart failure, severe renal impairment, clinical conditions presenting with edema and salt retention, in patients treated with cardiotropic drugs or corticosteroids or corticotropins.
• diabetes mellitus, monitor blood glucose levels in order to intervene with any necessary pharmacological adjustment

Due to the presence of potassium, administration should be guided by serial electrocardiograms;
potassemia is not indicative of intracellular potassium concentrations.
Monitor fluid balance, electrolytes, plasma osmolarity and acid-base balance.
Administer with intact renal function and at a perfusion rate not exceeding 10 mEq
potassium/hour.
ISOLYTE should not be administered simultaneously through the same transfusion kit with
blood or with citrate-based or blood preservatives.
Do not connect flexible plastic containers in series in order to avoid the formation of gaseous emboli following the presence of air in the primary container.
Completely eliminate any air present in the flexible plastic containers before
administration. Subjecting intravenous solutions contained in flexible plastic containers to high pressures in order to increase the flow rate may cause the formation of gaseous emboli if the
air content has not been completely eliminated.
Using a vented intravenous administration set with the vent open may cause the
formation of gaseous emboli. Vented intravenous administration sets with the vent in the
open position should not be used with flexible plastic containers

Hyperglycemia
In order to avoid hyperglycemia, the infusion rate should not exceed the patient's ability to
utilize glucose.
Hyperglycemia has been implicated in increased cerebral ischemia and mental damage and reduced recovery capacity after acute ischemic stroke. Caution is recommended in the use of glucose-containing solutions
in such patients.
Early hyperglycemia has been associated with poor outcomes in patients with severe brain injury
due to trauma. Glucose-containing solutions should also be used with caution in patients
with head injuries, particularly during the first 24 hours after trauma.
If hyperglycemia occurs, the glucose administration rate should be reduced or insulin should be administered or the insulin dose should be adjusted.
Administration of hyperosmotic solutions may cause venous irritation including phlebitis.

Method and time of administration
Use immediately after opening the container, after verifying its integrity.
Use for a single and uninterrupted administration. Any residue cannot be used and
must be disposed of.

Use aseptic technique.

1. Remove the bag from its protective pouch only when you are ready to use it.

2. Make sure there are no leaks by pressing the bag. Check the clarity

of the solution and the absence of foreign particles.

3. Hang the bag. Remove the protection from the outlet tube of the bag.

4. Connect the i.v. administration set to be used following the instructions

provided.
To read the volume during administration, gently pull the bag slightly above the
level of the solution.

• Precautions during administration
• Do not use air vents.
• Do not connect in series as it may produce a gaseous embolism due to the residual air carried from the first container, before administrationof the solution into the second container.
• Do not store partially used bags.
• Technique for introducing additional medicinesIf it is deemed necessary to introduce additional medicines, use an aseptic technique. Ensure complete mixing of the added substances and their compatibility.
• Keep the container in a vertical position, with the tubes facing upwards.
• Disinfect the injection site.
• Inject the medicine into the injection site using a 0.7-0.9 mm needle.
• Empty the tubes by pressing them and shake the container to mix the solution well and the added medicine.

Unused medicine and waste derived from such medicine must be disposed of in accordance with
current local regulations.

Overdose

Symptoms
Administration of excessive doses of ISOLYTE may cause metabolic alkalosis. Metabolic alkalosis may also be accompanied by hypokalemia and reduced levels of calcium and
magnesium ions in the serum.
Excessive volume of ISOLYTE may cause fluid and sodium retention and the risk of edema
(peripheral and/or pulmonary), especially when the ability to eliminate sodium at the renal level is
compromised.
Excessive administration of potassium may cause hyperpotassemia, especially in patients with
severe renal failure.
Excessive administration of calcium may cause hypercalcemia
Excessive administration of magnesium may cause hypermagnesemia
Excessive administration of glucose-containing solutions may cause hyperglycemia, hyperosmolarity,
osmotic diuresis and dehydration.
If the overdose is due to drugs added to the solution, the signs and symptoms will be related to
the added drugs.

TreatmentIn case of accidental overdose, treatment should be discontinued and the patient
should remain under observation to identify the signs and symptoms related to the administered drug. If
necessary, appropriate symptomatic and supportive measures should be taken.
When evaluating an overdose, any additive added to the solution should also be considered. The
effects of an overdose may require immediate treatment and clinical attention.