Ionolyte solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ionolyte infusion solution

Package leaflet:

1. What Ionolyte is and what it is used for

2. What you need to know before using Ionolyte

3. How to use Ionolyte

4. Possible side effects

5. Storage of Ionolyte

6. Contents of the pack and other information

1. What Ionolyte is and what it is 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 using 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 must not be administered to you if you have:

• hyperhydration (excess fluid in the body), especially in cases of pulmonary edema (fluid accumulation in the lungs) and congestive heart failure (the heart cannot pump enough blood to the body)
• severely impaired kidney function
• metabolic alkalosis (decreased blood acidity caused by a metabolic disorder)
• hyperkalemia (excessively high level of potassium in the blood)

Your doctor must check for these conditions.

Take special care with Ionolyte if:

• you have heart failure

• you have a severe cardiac rhythm disorder

• you have impaired kidney function

• you have a severe electrolyte imbalance (e.g., excessively high blood levels of potassium, sodium, magnesium, or chloride)

• you have high blood pressure

• you suffer from eclampsia (a pregnancy complication mainly characterized by high blood pressure and significant amounts of protein in the urine)

• you suffer from aldosteronism (a syndrome of high blood pressure and low blood potassium levels caused by excess of a hormone called aldosterone)

• you are receiving treatments or have conditions associated with 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 medicine used to treat heart conditions)

• you suffer from myasthenia gravis (a disease causing severe muscle weakness)

• you have recently undergone surgery and a muscle relaxant (neuromuscular blocker) was used

• large volumes of this solution are to be administered

Warnings and precautions

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

Children and adolescents

No special warnings or precautions apply.

Use of Ionolyte with other medicines

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

Ionolyte is not recommended if you are taking/using:

• corticosteroids/steroids and carbenoxolone (used to treat gastrointestinal ulcers), 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 (ACE) inhibitors and angiotensin II receptor antagonists (medicines mainly used to control blood pressure and treat heart failure)
• tacrolimus and cyclosporine (medicines used to prevent organ rejection)
• muscle relaxants
• salicylates (used to relieve pain and reduce fever)
• lithium (an antidepressant)
• alkaline medicines such as sympathomimetics (amphetamine-type)

Use of Ionolyte with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Ionolyte can be used safely during pregnancy and breastfeeding provided that fluid and electrolyte balance is monitored.

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

Driving and use of machines

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

3. How to use Ionolyte

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

You will receive your medication by intravenous infusion (intravenous drip). The volume and frequency of the infusion will depend on your individual requirements.

Your doctor will decide the appropriate dose you should receive.

If you receive more Ionolyte than you should

It is highly unlikely that you will receive more medication than intended, as this medicine will be administered by your doctor or nurse, who will monitor you during treatment. However, inform your doctor or nurse if you have any concerns.

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• fluid overload (excess fluid in the body) and heart failure in patients with heart disorders or pulmonary edema (accumulation of fluid 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 reduction in haematocrit (the proportion of blood volume occupied by red blood cells)

Other adverse effects include:

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

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

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 after opening.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. 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 osmolarity: 286.5 mOsm/l

Titratable acidity: < 2.5 mmol NaOH/l

pH: 6.9 – 7.9

Other components are:

Water for injections

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

Appearance of the product and contents of the pack

Ionolyte is a clear, colourless solution supplied 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 pack sizes.

Polyolefin bag (freeflex®) with overpouch: 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
[email protected]

Fresenius Kabi France
6 rue du Rempart
27400 Louviers
Tel: +33 2 32 09 59 00

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

Date of last review of this summary: February 2016

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This information is intended for healthcare professionals only:

Adults and pediatric population

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

Recommended dose:

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

To temporarily restore blood volume, a volume equivalent to 3 - 5 times the volume of blood lost must be administered.

Recommended usual doses:

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

For infants and children (from 28 days up to 11 years of age): 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 averages 5 ml/kg/hour, but varies with age: 6–8 ml/kg/hour for infants, 4–6 ml/kg/hour for children aged 1 to 2.5 years, and 2–4 ml/kg/hour for school-aged children.

Method of administration

Intravenous route