Ionolyte Solution for infusion – patient leaflet, side effects, dosage

1. What Ionolyte is and what it is used for

Ionolyte is a Solution for infusion.

Ionolyte is used for the treatment of:

• extracellular dehydration (water loss)
• hypovolaemia (sudden drop in volume of circulating blood)
• mild metabolic acidosis (increased acid in the blood caused by a metabolic disorder).

2. What you need to know before you are given 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 ingredients of this medicine (listed in section 6). You should not receive Ionolyte if you have
• hyperhydration (too much fluid in the body), especially in cases of pulmonary oedema (fluid accumulation in the lungs) and congestive cardiac failure (your heart cannot pump enough blood througout the body)
• severely impaired kidney function
• metabolic alkalosis (decreased acidity of the blood caused by a metabolic disorder)
• hyperkalaemia (too high blood levels of potassium) Your doctor will check these.

Special care will be taken with Ionolyte if

• you have heart failure
• you have severe heart rate disorders
• you have impaired kidney function
• you have severe electrolyte abnormalities (e.g. too high blood levels of potassium, sodium, magnesium or chloride)
• you have high blood pressure
• you suffer from eclampsia (complication of pregnancy mainly manifested by high blood pressure and significant amounts of protein in the urine)
• you suffer from aldosteronism (syndrome of high blood pressure and low blood potassium levels caused by an excess of the natural hormone aldosterone)
• you have other treatments or conditions associated with sodium retention (e.g. corticoids/steroids)
• you are taking potassium-sparing diuretics (used to increase the urine volume)
• you have severe potassium deficiency
• you have taken heavy doses of digitalis (a medicine used for treatment of heart diseases)
• you suffer from myasthenia gravis (a disease involving severe muscle weakness)
• you recently had an operation where a muscle relaxant was used (neuromuscular block)
• larger volumes of this solution are to be used

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Ionolyte.

Children and adolescents

No special warnings and precautions.

Other medicines and Ionolyte

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Ionolyte is not recommended if you are taking/using:

• corticoids/steroids and carbenoxolone (for the treatment of digestive tract ulcers) as these are associated with retention of sodium and water (with fluid accumulation in tissues and high blood pressure)
• potassium-sparing diuretics (used to increase the urine volume, such as amiloride, spironolactone, triamterene, given alone or in combination)
• angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists (medicines that are mainly used for controlling blood pressure, treating heart failure)
• tacrolimus and cyclosporine (medicine used to prevent organ rejection)
• muscle relaxants
• salicylates (used to ease pains and reduce fever)
• lithium (anti-depressant)

• alkaline drugs like sympathomimetics (such as amphetamine). Ionolyte with food and drink

Ionolyte is not known to have any negative effect when given at the same time as food and drink.

Pregnancy and breast-feeding

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

Ionolyte can be used safely during pregnancy and breast- feeding as long as the electrolyte and fluid balance is controlled. When another medicinal product is added to Ionolyte, the nature of the drug and its use during pregnancy and breast-feeding have to be considered separately. 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 given to you in hospital by a doctor or nurse. You will receive your medicine by intravenous infusion (infusion into a vein).

The amount and rate at which the infusion is given depends on your condition. Your doctor will decide on the correct dose for you to receive.

If you are given more Ionolyte than you should It is very unlikely that you will receive more infusion than you should, because this medicine will be given to you by your doctor or nurse who will monitor you during the treatment. However, tell your doctor or nurse if you have any concerns. In the event of accidental overdose, treatment will be stopped and you will be observed for signs and symptoms related to the drug. Therapeutic removal of excessive fluid might be necessary. 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, alt-hough not everybody gets them.

Very common (more than 1 in 10 patients):

• hyperhydration (too much fluid in your body) and heart failure in patients with heart disorder or pulmonary oedema (fluid accumulation in the lungs)

Common (more than 1 in 100 patients, but less than 1 in 10 patients):

• Large volumes of this solution may lead to dilution of com-ponents of the blood and decrease in the haematocrit (pro-portion of blood volume that is occupied by red blood cells) Other side effects include:
• fluid accumulation in tissues (oedema)
• fever
• infection at the site of injection, local pain or reaction
• vein irritation, venous thrombosis (formation of a clot) or phlebitis (inflammation of the vein) extending from the site of injection
• extravasation (fluid leakage from the vein)

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly; For UK - Via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard

For Ireland – Via;

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 which is stated on the label. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environ-ment.

6. Contents of the pack and other information

What Ionolyte contains

• The active substances are:

  500 ml 1000 ml Sodium acetate trihydrate 2.32 g 4.63 g Sodium chloride 3.01 g 6.02 g Potassium chloride 0.15 g 0.30 g Magnesium chloride hexahydrate 0.15 g 0.30 g

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:

Titrable acidity:

pH:

• The other ingredients are:

  Water for injections

  Sodium hydroxide (for pH-adjustment)

  Hydrochloric acid (for pH-adjustment)

What Ionolyte looks like and contents of the pack Ionolyte is a clear and colourless solution packed in a flexible sealed plastic container known as a freeflex^® bag or in a plastic

bottle known as a KabiPac^®.

The solution is available in 500 ml or 1000 ml presentation. Polyolefine bag (freeflex^®) with overwrap: 20 x 500 ml, 10 x 1000 ml LDPE bottle (KabiPac^®): 10 x 500 ml, 20 x 500 ml, 10 x 1000 ml

Not all pack sizes may be marketed.

286.5 mOsm/l < 2.5 mmol NaOH/l

6.9 – 7.9

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

MAH for UK:

Fresenius Kabi Limited

Cestrian Court, Eastgate Way, Manor Park, Runcorn,

Cheshire, WA7 1NT

UK

MAH for IE:

Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,

61352 Bad Homburg

v.d.Höhe

Germany

Manufacturer:

Fresenius Kabi Deutschland GmbH 61169 Friedberg

Tel: +49 6172 686 8667

Kundenberatung@fresenius-kabi.de This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in July 2020.