PROSPECTO : INFORMATION FOR THE USER

Ionolyte solution for perfusion

5. Storage of Ionolyte

6. Contents of the container and additional information

Ionolyte is a perfusion solution.

Ionolyte is used in the treatment of:

• extracellular dehydration (water loss)
• hypovolemia (rapid decrease in circulating blood volume)
• mild metabolic acidosis (increase in blood acidity caused by a metabolic disorder)

No use Ionolyte:

• If you are allergic to sodium trihydrate acetate, sodium chloride, potassium chloride, magnesium chloride hexahydrate, or any of the other components of this medication (listed in section 6).

Do not administer Ionolyte if you have:

-excessive hydration (too much fluid in your body), especially in cases of pulmonary edema (fluid accumulation in the lungs) and congestive heart failure (the heart cannot pump enough blood to the entire body)
(fluid accumulation in the lungs and congestive heart failure)

-severely impaired renal function

-metabolic alkalosis (a metabolic disorder causing a decrease in blood acidity)

-hyperkalemia (elevated potassium levels in the blood)

Your doctor must check this.

Be extra cautious with Ionolyte if:

-you have heart failure

-you have a severe cardiac arrhythmia

-you have altered renal function

-you have a severe electrolyte anomaly (e.g. elevated levels of potassium, sodium, magnesium, or chloride in the blood)

-you have high blood pressure

-suffer from eclampsia (a complication of pregnancy primarily manifested by high blood pressure and significant proteinuria)

-suffer from aldosteronism (a condition of high blood pressure and low potassium levels in the blood caused by an excess of aldosterone hormone)

-receiving other treatments or suffering from conditions related to sodium retention (e.g. corticosteroids, steroids)

-taking potassium-sparing diuretics (used to increase urine volume)

-severe potassium deficiency

-having taken high doses of digitalis (a medication used to treat heart diseases)

-suffering from myasthenia gravis (a disease involving severe muscle weakness)

-having recently undergone surgery and used a muscle relaxant (neuromuscular blockade)

-administering large volumes of this solution

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Ionolyte.

Children and adolescents

No special warnings and precautions are noted.

Use of Ionolyte with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Ionolyte is not recommended if you are taking/using:

• corticosteroids/steroids and carbenoxolone (for the treatment of digestive system ulcers) as these are associated with sodium and water retention (fluid accumulation in tissues and high blood pressure).
• potassium-sparing diuretics (used to increase urine volume, such as amiloride, spironolactone, triamterene, administered alone or in combination)
• angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists (medications primarily used to control blood pressure, heart failure treatment)
• tacrolimus and cyclosporine (medications used to prevent organ rejection)
• muscle relaxants
• salicylates (used to relieve pain and reduce fever)
• lithium (antidepressant)
• alkaline medications such as sympathomimetics (e.g. amphetamines)

Use of Ionolyte with food and beverages

Ionolyte has not shown any negative effects when administered with food and beverages.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Ionolyte can be used safely during pregnancy and lactation as long as the electrolyte and fluid balance is controlled.

When adding another medication to Ionolyte, the nature of the medication and its use during pregnancy and lactation should be considered independently. Your doctor will discuss this with you.

Driving and operating machinery

Ionolyte has no effect on the ability to drive or operate machinery.

Ionolyte will be administered to you in a hospital by a doctor or nurse.

You will receive your medication through intravenous infusion (drop by drop through a vein). The volume and interval of the infusion that they administer to you will depend on your needs.

Your doctor will decide what is the suitable dose that you should receive.

If you receive more Ionolyte than you should

It is very unlikely that you will receive more medication than you should, because this medication will be administered to you by your doctor or nurse who will be monitoring you during treatment. However, inform your doctor or nurse if you have any doubts.

In the event of an accidental overdose, treatment will be stopped and you will be observed for the possible appearance of signs and symptoms related to the medication. You may need therapeutic removal of excess fluid.

In cases of overdose or accidental ingestion, consult the Toxicological Information Service, Phone: 91-5620420

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Very common (may affect more than 1 in 10 people):

• Hyperhydration (excess fluid in the body) and heart failure in patients with heart disorder or pulmonary edema (fluid accumulation in the lungs)

Common (may affect up to 1 in 10 people, but less than 1 in 10 patients):

• Large volumes of this solution may lead to dilution of blood components and decrease hematocrit (proportion of blood volume occupied by red blood cells)

Other adverse effects include:

• Fluid accumulation in tissues (edema)
• Fever
• Infection at the injection site, local reaction or pain
• Vein irritation, venous thrombosis (formation of a clot) or phlebitis (vein inflammation) extending from the injection site
• Extravasation (loss of fluid from the vein)

You will be monitored by your doctor or nurse during treatment with this medication. If any of these adverse effects appear, treatment will be stopped.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not refrigerate or freeze.

Keep this medication out of the sight and reach of children.

The product must be used immediately once opened.

Do not use this medication after the expiration date that appears on the label after CAD.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Protect the environment.

Electrolytes:

Na+137.0 mmol/l

K+4.0 mmol/l

Mg++1.5 mmol/l

Cl-110.0 mmol/l

CH3COO-34.0 mmol/l

Theoretical osmolality:286.5 mOsm/l

Titration acidity:2.5 mmol NaOH/l

pH:6.9 – 7.9

The other components are:

Water for injection

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

Appearance of the product and contents of the package

Ionolyte is a transparent and colorless solution that is presented in a sealed plastic bag known as afreeflex®or in plastic bottles known as KabiPac®.

The solution is available in presentations of 500 ml or 1000 ml.

Bag of polyolefin (freeflex®) with overbag: 20 x 500 ml, 10 x 1000 ml

LDPE bottle (KabiPac®): 10 x 500 ml, 10 x 1000 ml

It may not be all packaging sizes that are marketed.

Holder of the marketing authorization and responsible manufacturer

Holder:

Fresenius Kabi España, S.A.U

C/ Marina 16-18

08005-BARCELONA (Spain)

Manufacturer:

Fresenius Kabi Deutschland GmbH

61169 Friedberg

Tel: +49 6172 686 8667

[email protected]

Fresenius Kabi France

6 rue du Rempart

27400 Louviers

Tel: +33 2 32 09 59 00

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: February 2016

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This information is intended solely for healthcare professionals:

Adults and pediatric population

The dose and rate of administration depend on the age, body weight, clinical and biological condition of the patient (including acid-base balance) and concomitant treatment.

Recommended dose:

The maximum daily dose depends on the patient's fluid and electrolyte needs.

To temporarily restore blood volume, a volume equivalent to 3-5 times the lost blood volume is required.

Usual recommended doses:

For adults, elderly and adolescents (from 12 years): 500 ml to 3 liters/24 hours.

For infants and children (from 28 days to 11 years): 20 ml/kg to 100 ml/kg/24 hours.

Administration rate:

In continuous treatments, except in cases of severe fluid loss, the perfusion rate is normally 40 ml/kg/24 hours in adults.

In pediatric patients, the perfusion rate is 5 ml/kg/hour on average, but the value varies with age: 6-8 ml/kg/hour for infants, 4-6 ml/kg/h for children aged 1 to 2 years and a half, and 2-4 ml/kg/hour for school-age children.

Administration form

Intravenous