Ionovol

Package leaflet: Information for the user

Ionovol infusion solution

Please read this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Ionovol is and what it is used for
2. What you need to know before Ionovol is administered to you
3. How Ionovol is administered
4. Possible side effects
5. How to store Ionovol
6. Contents of the pack and other information

1. What Ionovol is and what it is used for

Ionovol is an infusion solution.
Ionovol is used for the treatment of:

• Extracellular dehydration (loss of water)
• Hypovolemia (sudden decrease in circulating blood volume)
• Mild metabolic acidosis (increased blood acidity caused by a metabolic disorder)

2. What you need to know before being given Ionovol

Do not use Ionovol

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

You must not receive Ionovol 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 is unable to pump an adequate amount of blood through the body)
• Severe impairment of kidney function
• Metabolic alkalosis (decreased blood acidity caused by metabolic disorders)
• Hyperkalemia (excessively high levels of potassium in the blood)

Your doctor will check for these conditions.
Special caution is needed with Ionovol if you:

• Have heart failure
• Have severe heart rhythm disorders
• Have impaired kidney function
• Have severe electrolyte imbalances (for example, excessively high levels of potassium, sodium, magnesium, or chloride in the blood)
• Have high blood pressure
• Suffer from eclampsia (a pregnancy complication characterized mainly by high blood pressure and significant amounts of protein in the urine)
• Suffer from aldosteronism (a syndrome of high blood pressure and low potassium levels in the blood caused by excess of the natural hormone aldosterone)
• Are receiving other treatments or have conditions associated with sodium retention (e.g., corticosteroids/steroids)
• Are taking potassium-sparing diuretics (used to increase urine volume)
• Have severe potassium deficiency
• Have taken high doses of digitalis (a medicine used to treat heart conditions)
• Suffer from myasthenia gravis (a disease involving severe muscle weakness)
• Have recently undergone surgery involving the use of a muscle relaxant (neuromuscular blockade)
• Are receiving large volumes of this solution

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ionovol.
Children and adolescents
There are no specific warnings or precautions.
Other medicines and Ionovol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ionovol is not recommended if you are taking/using:

• Corticosteroids/steroids and carbenoxolone (used to treat ulcers of the digestive tract), 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 (e.g., amphetamines)

Ionovol with food and drinks
It is not known that Ionovol has negative effects when administered with food and drinks.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
This medicine can be used safely during pregnancy and breastfeeding provided that electrolyte and fluid balance is monitored.
When another medicine is added to Ionovol, the nature of that drug and its use during pregnancy and breastfeeding must be considered separately. Your doctor will discuss this with you.
Driving and using machines
Ionovol has no effect on your ability to drive or operate machinery.

3. How Ionovol is administered

Ionovol will be administered to you in a hospital by a doctor or nurse.
It will be given as an intravenous infusion (an infusion into a vein).
The amount and rate at which the infusion is administered will depend on your condition. The doctor will decide the correct dose for you.
If you receive more Ionovol than you should
It is very unlikely that you will receive more infusion than required, as the medicine will be administered by a doctor or nurse who will monitor you during treatment. However, inform the doctor or nurse if you have any concerns.
In case of accidental overdose, treatment will be stopped and you will be monitored for any drug-related signs and symptoms. Therapy to remove excess fluid may be necessary.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

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):

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

• large volumes of this solution may lead to dilution of blood components and reduction in haematocrit (the percentage of blood volume occupied by red blood cells)

Other side effects include:

• accumulation of fluid in tissues (oedema)
• fever
• infection at injection site, pain or local reaction
• venous irritation, venous thrombosis (blood clot formation), or phlebitis (vein inflammation) 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 side effects occur, treatment will be stopped.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ionovol

Do not refrigerate or freeze.
Keep this medicine out of the sight and reach of children.
The medicine should be used immediately after opening.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ionovol 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
CH\textsubscript{3}COO 34.0 mmol/l
Theoretical osmolarity: 286.5 mOsm/l
Titratable acidity: < 2.5 mmol NaOH/l
pH: 6.9 – 7.9
The other components are:
water for injections
sodium hydroxide (for pH adjustment)
hydrochloric acid (for pH adjustment)

Description of the appearance of Ionovol and package contents
Ionovol is a clear, colourless solution contained in a sealed flexible plastic bag known as free\textit{flex} or in a plastic bottle known as KabiPac.
The solution is available in 500 ml and 1000 ml bags or bottles.
Polyolefin bag (free\textit{flex}®) with overpouch: 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
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala, Verona
Italy

Manufacturer responsible for batch release
Fresenius Kabi Deutschland GmbH
61169 Friedberg
Germany
Fresenius Kabi France
6 rue du Rempart
27400 Louviers
France

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

The following information is intended exclusively for healthcare professionals:

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

Recommended dosage:
The maximum daily dose corresponds to the amount of fluids and electrolytes required by the patient. To restore lost blood volume, 3 to 5 times the volume of blood lost is required.
Typical recommended dosages are:
For adults, elderly patients, and adolescents (aged 12 years and older): 500 ml to 3 liters/24 hours.
For neonates, toddlers, 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 treatment, outside of acute fluid losses, the infusion rate is generally 40 ml/kg/24 hours in adults.
In pediatric patients, the average infusion rate is 5 ml/kg/hour, but this value varies with age: 6–8 ml/kg/hour for neonates, 4–6 ml/kg/hour for toddlers, and 2–4 ml/kg/hour for children.

Method of administration
For intravenous use.