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IONOLYTE SOLUTION FOR INFUSION

Active substance(s): MAGNESIUM CHLORIDE HEXAHYDRATE / POTASSIUM CHLORIDE / SODIUM ACETATE TRIHYDRATE / SODIUM CHLORIDE

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0xxxxx1_00_Ionolyte_Kabipac_PB 01.09.2015 16:51 Seite 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ionolyte Solution for infusion

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Ionolyte is and what it is used for
2.
What you need to know before you are given Ionolyte
3.
How you are given Ionolyte
4.
Possible side effects
5.
How to store 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 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).

V001/FB

1

0xxxxx1_00_Ionolyte_Kabipac_PB 01.09.2015 16:51 Seite 2

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)

2

0xxxxx1_00_Ionolyte_Kabipac_PB 01.09.2015 16:51 Seite 3

• 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.

3

0xxxxx1_00_Ionolyte_Kabipac_PB 01.09.2015 16:51 Seite 4

4. Possible side effects
Like all medicines this medicine can cause side effects, although 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 components of the blood and
decrease in the haematocrit (proportion 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 treatment 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.

4

0xxxxx1_00_Ionolyte_Kabipac_PB 01.09.2015 16:51 Seite 5

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 environment.

6. Contents of the pack and other information
What Ionolyte contains
• The active substances are:
Sodium acetate trihydrate
Sodium chloride
Potassium chloride
Magnesium chloride hexahydrate
Electrolytes:
Na+
K+
Mg++
ClCH3COO-

500 ml
2.32 g
3.01 g
0.15 g
0.15 g

1000 ml
4.63 g
6.02 g
0.30 g
0.30 g

137.0 mmol/l
4.0 mmol/l
1.5 mmol/l
110.0 mmol/l
34.0 mmol/l

Theoretical osmolarity:
Titrable acidity:
pH:

286.5 mOsm/l
< 2.5 mmol NaOH/l
6.9 – 7.9

• 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.

5

0xxxxx1_00_Ionolyte_Kabipac_PB 01.09.2015 16:51 Seite 6

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT
UK
Manufacturer:
Fresenius Kabi Deutschland GmbH
61169 Friedberg
Tel: +49 6172 686 8667
Kundenberatung@fresenius-kabi.de

6

0xxxxx1_00_Ionolyte_Kabipac_PB 01.09.2015 16:51 Seite 7

This medicinal product is authorised in the Member States of the EEA
under the following names:
Belgium

Ionolyte, oplossing voor infusie

Bulgaria

Ionolyte

Croatia

Ionolyte, otopina za infuziju

Cyprus

Ionolyte, διάλυμα για έγχυση

Czech Republic

Isolyte, Infuzní roztok

France

Ionoven, solution pour perfusion

Greece

Ionolyte, διάλυμα για έγχυση

Hungary

Isolyte, oldatos infúzió

Ireland

Ionolyte Solution for infusion

Italy

Ionolyte

Malta

Ionolyte Solution for infusion

Netherlands

Ionolyte, oplossing voor infusie

Norway

Ionolyte infusjonsvæske, oppløsning

Poland

Venolyte

Portugal

Ionoven, solução para perfusão

Romania

Ionolyte solu ie perfuzabil

Slovakia

Isolyte, infúzny roztok

Slovenia

Ionolyte raztopina za infundiranje

Spain

IONOLYTE solución para perfusión

United Kingdom

Ionolyte Solution for infusion

This leaflet was last revised in 08/2015.

7

0xxxxx1_00_Ionolyte_Kabipac_PB 01.09.2015 16:51 Seite 8

The following information is intended for healthcare professionals only:
Posology
Adults and paediatric patients
The dose and rate of administration depends on age, body weight, clinical and
biological conditions of the patient (including acid-base balance) and the concomitant therapy.
Recommended dosage:
The maximum daily dose corresponds to the fluid and electrolyte needs of the
patient. To temporary restore blood volume 3 to 5 times the volume of the lost
blood is required.
Typical recommended dosages are:
For adults, the elderly and adolescents (age 12 years and above): 500 ml to 3
litres/24 hours.
For infants, toddlers and children (from 28 days to 11 years of age): 20 ml/kg to
100 ml/kg/24 hours.
Administration rate:
In continuous treatment outside acute fluid losses the infusion rate is usually 40
ml/kg/24 hours in adults.
In pediatric patients the infusion rate is 5 ml/kg/hour in average but the value varies with the age: 6-8 ml/kg/hour for infants, 4-6 ml/kg/h for toddlers, and 2-4
ml/kg/hour for school children.
Method of administration
For intravenous use.

8

0xxxxx1_00_Ionolyte_FreeFlex_PB 01.09.2015 16:59 Seite 1

Ionolyte Solution for infusion
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1.
What Ionolyte is and what it is used for
2.
What you need to know before you are given Ionolyte
3.
How you are given Ionolyte
4.
Possible side effects
5.
How to store 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 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)

V001/FB

1

0xxxxx1_00_Ionolyte_FreeFlex_PB 01.09.2015 16:59 Seite 2








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 breastfeeding 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, although 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 components of the blood and decrease in the haematocrit (proportion of
blood volume that is occupied by red blood cells)

2

0xxxxx1_00_Ionolyte_FreeFlex_PB 01.09.2015 16:59 Seite 3

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
treatment 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 environment.

6. Contents of the pack and other information
What Ionolyte contains
• The active substances are:
Sodium acetate trihydrate
Sodium chloride
Potassium chloride
Magnesium chloride hexahydrate
Electrolytes:
Na+
K+
Mg++
ClCH3COO-

500 ml
2.32 g
3.01 g
0.15 g
0.15 g

137.0 mmol/l
4.0 mmol/l
1.5 mmol/l
110.0 mmol/l
34.0 mmol/l

Theoretical osmolarity:
Titrable acidity:
pH:

286.5 mOsm/l
< 2.5 mmol NaOH/l
6.9 – 7.9

• The other ingredients are:
Water for injections
Sodium hydroxide (for pH-adjustment)
Hydrochloric acid (for pH-adjustment)

3

1000 ml
4.63 g
6.02 g
0.30 g
0.30 g

0xxxxx1_00_Ionolyte_FreeFlex_PB 01.09.2015 16:59 Seite 4

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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT
UK
Manufacturer:
Fresenius Kabi Deutschland GmbH
61169 Friedberg
Tel: +49 6172 686 8667
Kundenberatung@fresenius-kabi.de

4

0xxxxx1_00_Ionolyte_FreeFlex_PB 01.09.2015 16:59 Seite 5

This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium

Ionolyte, oplossing voor infusie

Bulgaria

Ionolyte

Croatia

Ionolyte, otopina za infuziju

Cyprus

Ionolyte, διάλυμα για έγχυση

Czech Republic

Isolyte, Infuzní roztok

France

Ionoven, solution pour perfusion

Greece

Ionolyte, διάλυμα για έγχυση

Hungary

Isolyte, oldatos infúzió

Ireland

Ionolyte Solution for infusion

Italy

Ionolyte

Malta

Ionolyte Solution for infusion

Netherlands

Ionolyte, oplossing voor infusie

Norway

Ionolyte infusjonsvæske, oppløsning

Poland

Venolyte

Portugal

Ionoven, solução para perfusão

Romania

Ionolyte solu ie perfuzabil

Slovakia

Isolyte, infúzny roztok

Slovenia

Ionolyte raztopina za infundiranje

Spain

IONOLYTE solución para perfusión

United Kingdom

Ionolyte Solution for infusion

This leaflet was last revised in 08/2015.

5

0xxxxx1_00_Ionolyte_FreeFlex_PB 01.09.2015 16:59 Seite 6

The following information is intended for healthcare professionals only:
Posology
Adults and paediatric patients
The dose and rate of administration depends on age, body weight, clinical and biological conditions of the patient (including acid-base balance) and the concomitant therapy.
Recommended dosage:
The maximum daily dose corresponds to the fluid and electrolyte needs of the patient. To temporary restore blood volume
3 to 5 times the volume of the lost blood is required.
Typical recommended dosages are:
For adults, the elderly and adolescents (age 12 years and above): 500 ml to 3 litres/24 hours.
For infants, toddlers and children (from 28 days to 11 years of age): 20 ml/kg to 100 ml/kg/24 hours.
Administration rate:
In continuous treatment outside acute fluid losses the infusion rate is usually 40 ml/kg/24 hours in adults.
In pediatric patients the infusion rate is 5 ml/kg/hour in average but the value varies with the age: 6-8 ml/kg/hour for infants,
4-6 ml/kg/h for toddlers, and 2-4 ml/kg/hour for school children.
Method of administration
For intravenous use.

6

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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