IONOLYTE SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ionolyte solution for infusion

Contents of the pack:

1. What is Ionolyte and what is it used for
2. What you need to know before you use Ionolyte
3. How to use Ionolyte
4. Possible side effects

1. Storage of Ionolyte
2. Contents of the pack and other information

1. What is Ionolyte and what is it used for

Ionolyte is a solution for infusion.

Ionolyte is used in the treatment of:

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

2. What you need to know before you use Ionolyte

Do not use Ionolyte:

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

Ionolyte should not be administered to you if you have:

• hyperhydration (too much fluid in your body), especially in cases of pulmonary edema (fluid accumulation in the lungs) and congestive heart failure (the heart is unable to pump enough blood to the whole body)
• severely impaired renal function
• metabolic alkalosis (decrease in blood acidity caused by a metabolic disorder)
• hyperkalemia (high potassium levels in the blood)

Your doctor should check this.

Be careful with Ionolyte if you have:

• heart failure
• a severe cardiac rhythm disorder
• altered renal function
• a severe electrolyte imbalance (e.g. high levels of potassium, sodium, magnesium or chloride in the blood)
• high blood pressure
• eclampsia (a complication of pregnancy characterized by high blood pressure and significant amounts of protein in the urine)
• aldosteronism (a syndrome of high blood pressure and low potassium levels in the blood caused by an excess of a hormone called aldosterone)
• you are receiving other treatments or have conditions related to sodium retention (e.g. corticosteroids, steroids)
• you are taking potassium-sparing diuretics (used to increase urine volume)
• you have severe potassium deficiency
• you have taken high doses of digitalis (a medication used to treat heart conditions)

corazón)

• you have myasthenia gravis (a disease that involves severe muscle weakness)
• you have recently undergone surgery and a muscle relaxant (neuromuscular blockade) has been used
• you are going to receive large volumes of this solution

Warnings and precautions

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

Children and adolescents

There are no special warnings and precautions.

Using Ionolyte with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Ionolyte is not recommended if you are taking/using:

• corticosteroids/steroids and carbenoxolone (for the treatment of ulcers of the digestive system) as these are associated with sodium and water retention (with 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 (medicines used primarily to control blood pressure, treatment of heart failure)
• tacrolimus and cyclosporin (medicines used to prevent organ rejection)
• muscle relaxants
• salicylates (used to relieve pain and reduce fever)
• lithium (antidepressant)
• alkaline medicines such as sympathomimetics (e.g. amphetamines)

Using Ionolyte with food and drinks

Ionolyte has not shown any negative effects when administered at the same time as food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Ionolyte can be used safely during pregnancy and breastfeeding as long as electrolyte and fluid balance is monitored.

When another medicine is added to Ionolyte, the nature of the medicine and its use during pregnancy and breastfeeding should be considered independently. Your doctor will discuss this with you.

Driving and using machines

Ionolyte has no effect on the ability to drive or use machines.

3. How to use Ionolyte

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

You will receive your medicine by intravenous infusion (drip by drip through a vein). The volume and interval of the infusion that you are given will depend on your needs.

Your doctor will decide what dose is suitable for you to receive.

If you receive more Ionolyte than you should

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

In the event of an accidental overdose, treatment will be stopped and you will be monitored for any signs and symptoms related to the medicine. Therapeutic removal of excess fluid may be necessary.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• hyperhydration (too much fluid in your body) and heart failure in patients with heart disorders 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 a dilution of blood components and decrease hematocrit (proportion of blood volume occupied by red blood cells)

Other side effects include:

• fluid accumulation in tissues (edema)
• fever
• infection at the injection site, reaction or local pain
• irritation of the veins, venous thrombosis (formation of a blood clot) or phlebitis (inflammation of the vein) extending from the injection site
• extravasation (fluid loss from the vein)

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ionolyte

Do not refrigerate or freeze.

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

The product should be used immediately once opened.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

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 ingredients are:

Water for injections

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

Appearance and packaging

Ionolyte is a clear and colorless solution presented in a sealed plastic container known as a freeflex®bag or in plastic bottles known as KabiPac®.

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

Polyolefin bag (freeflex®) with overbag: 20 x 500 ml, 10 x 1000 ml

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

Kundenberatung@fresenius-kabi.de

Fresenius Kabi France

6 rue du Rempart

27400 Louviers

Tel: +33 2 32 09 59 00

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: February 2016

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This information is intended only 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.

Rate of administration:

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

In pediatric patients, the infusion 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/hour for children from 1 to 2 years and a half, and 2-4 ml/kg/hour for school-age children.

Method of administration

Intravenous route