Package leaflet: Information for the user

Venolyte, infusion solution
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See
section 4.

Contents of the leaflet

What Venolyte is and what it is used for
What you need to know before using Venolyte
How to use Venolyte
Possible side effects
How to store Venolyte
Contents of the pack and other information

1. What Venolyte is and what it is used for

Venolyte is an infusion solution.
Venolyte is used in the treatment of:
extracellular dehydration (loss of water);
hypovolaemia (sudden reduction in circulating blood volume);
mild metabolic acidosis (increased blood acidity caused by metabolic disorders).

2. Information before using Venolyte

When not to use Venolyte:
if the patient is 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).
Venolyte must not be used if the patient:
is overhydrated (excess fluid in the body), especially in case of pulmonary edema (fluid accumulation in the lungs) and in congestive heart failure (heart unable to pump sufficient blood through the body);
has severe kidney function disorders;
has metabolic alkalosis (reduced blood acidity due to metabolic disorders);
has hyperkalemia (excessively high potassium levels in the blood).
The doctor will check whether any of the above conditions apply to the patient.

When to exercise special caution with Venolyte:
if the patient has heart failure;
if the patient has severe cardiac arrhythmias;
if the patient has impaired kidney function;
if the patient has severe electrolyte imbalances (e.g. excessively high levels of potassium, sodium, magnesium, or chlorides);
if the patient has high blood pressure;
if the female patient has eclampsia (a pregnancy complication primarily characterized by high blood pressure and significant protein in the urine);
if the patient has hyperaldosteronism (characterized by high blood pressure and low potassium levels due to excess hormone - aldosterone);
if the patient is receiving other treatments or has symptoms related to sodium retention in the body (e.g. corticosteroids/steroids);
if the patient is taking potassium-sparing diuretics (used to increase urine volume);
if the patient has significant potassium deficiency;
if the patient has taken large doses of digitalis (a medicine used in the treatment of heart diseases);
if the patient has myasthenia (a disease characterized by significant muscle weakness);
if the patient has recently undergone surgery and received muscle relaxants (neuromuscular blocking agents);
when large volumes of this solution are administered.

Warnings and precautions
Before starting treatment with Venolyte, discuss it with your doctor, pharmacist, or nurse.

Children and adolescents
No special warnings or precautions.

Venolyte and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.

Venolyte is not recommended if the patient is taking:
corticosteroids/steroids or carbenoxolone (a medicine used in the treatment of gastrointestinal ulcers), because their use is associated with sodium and water retention in the body (fluid accumulation in tissues and increased blood pressure);
potassium-sparing diuretics (used to increase urine volume, such as amiloride, spironolactone, triamterene, used as monotherapy or in combination with other medicines);
angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists (medicines used mainly to control blood pressure and treat heart failure);
tacrolimus and cyclosporine (medicines used to prevent transplant rejection);
muscle relaxants;
salicylates (medicines used to relieve pain and reduce fever);
lithium (an antidepressant medicine);
alkaline drugs, e.g. sympathomimetics (such as amphetamine).

Venolyte with food and drink
No data available on negative effects when used concomitantly with food and drink.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Venolyte can be safely used during pregnancy and breastfeeding as long as water and electrolyte balance is monitored and maintained.
If another medicine has been added to Venolyte, its properties and use during pregnancy and breastfeeding must be considered separately. The doctor will discuss this with the patient.

Driving and operating machinery
Venolyte does not affect the ability to drive or operate machinery.

3. How to use Venolyte

Venolyte is administered in a hospital setting by a doctor or nurse.
The patient will receive this medicine as an intravenous infusion (infusion into a vein).
The amount of medicine and the rate of administration depend on the patient's condition. The doctor will decide the appropriate dose for the patient.

Use of a higher than recommended dose of Venolyte
It is unlikely that a patient will receive a higher dose than recommended, as this medicine is administered by a doctor or nurse who monitors the patient's condition during treatment. However, any concerns should be reported to the doctor or nurse immediately.

In case of accidental overdose, administration of the medicine will be stopped and the patient will be monitored for any medicine-related symptoms. Treatment may be necessary to remove excess fluid.

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very common (affects more than 1 in 10 patients):
fluid overload (excess fluid in the body) and heart failure in patients with heart disease or
pulmonary oedema (accumulation of fluid in the lungs).
Common (affects more than 1 in 100 patients but less than 1 in 10 patients):
dilution of blood components and decreased haematocrit (the proportion of blood volume occupied by
red blood cells), particularly after administration of a large volume of this solution.
Other adverse effects:
fluid accumulation in tissues (oedema);
fever;
infection at the injection site, local pain or reaction;
vein irritation, venous thrombosis (blood clot formation), or phlebitis spreading from the site of administration;
extravasation (leakage of fluid from the vein).
The doctor or nurse will monitor the patient during treatment with this medicine. If any of these adverse effects occur, treatment will be discontinued.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Email: [email protected]
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Venolyte

Do not store in the refrigerator or freeze.
Keep the medicine in a place invisible and inaccessible to children.
The medicine should be used immediately after opening the bottle or bag.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the package and other information

What Venolyte contains
The active substances in the medicine 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
Other components of the medicine are: water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).
What Venolyte looks like and contents of the pack
Venolyte is a clear, colourless solution packed in a flexible, heat-sealed plastic bag of free\textit{flex} type or in a KabiPac plastic bottle.
The solution is available in packs of 500 ml or 1000 ml.
Polyolefin bags (free\textit{flex}) in protective foil packaging: 20 x 500 ml, 10 x 1000 ml.
LDPE bottles (KabiPac): 10 x 500 ml, 20 x 500 ml, 10 x 1000 ml.
Not all pack sizes may be available on the market.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Manufacturer
Fresenius Kabi Deutschland GmbH
Freseniusstrasse 1
61169 Friedberg
Germany
Fresenius Kabi France
6 rue du Rempart
27400 Louviers
France
This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium Ionolyte, solution for infusion
Bulgaria Йонолайт инфузионен разтвор
Czech Republic Isolyte Infuzní roztok
Croatia Ionolyte, otopina za infuziju
Cyprus Ionolyte, διάλυμα για έγχυση
France Ionoven, solution for perfusion
Greece Ionolyte, διάλυμα για έγχυση
Spain IONOLYTE solución para perfusión
Netherlands Ionolyte, oplossing voor infusie
Ireland Ionolyte Solution for infusion
Malta Ionolyte solution for infusion
Poland Venolyte
Portugal Ionolyte
Romania Ionolyte soluție perfuzabilă
Slovakia Isolyte, infúzny roztok
Slovenia Ionolyte raztopina za infundiranje
Hungary Isolyte, oldatos infúzió
United Kingdom Ionolyte Solution for infusion
Italy Ionovol

Information intended exclusively for medical professionals:

Dosing
Adults, children, and adolescents
The dose and infusion rate depend on age, body weight, clinical condition, and biological parameters of the patient (including acid-base balance) as well as concomitant therapies.
Recommended doses
The maximum daily dose corresponds to the patient's requirements for fluids and electrolytes. For temporary blood volume replacement, a volume 3 to 5 times greater than the lost blood volume must be administered.
Recommended dose in typical cases
Adults, elderly patients, and adolescents (aged 12 years and above): 500 ml to 3 liters/24 hours.
Infants, toddlers, and children (from 28 days to 11 years of age): 20 ml/kg body weight to 100 ml/kg body weight/24 hours.
Infusion rate
In long-term treatment of adult patients, apart from severe fluid loss, the infusion rate is usually 40 ml/kg body weight/24 hours.
In children and adolescents, the infusion rate is usually 5 ml/kg body weight/hour, but varies depending on age: infants 6 to 8 ml/kg body weight/hour, toddlers 4 to 6 ml/kg body weight/hour, school-aged children 2 to 4 ml/kg body weight/hour.
Route of administration
For intravenous administration.