Venolite

Leaflet attached to the packaging: information for the user

Venolyte, solution for infusion

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.
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Keep this leaflet, you may need to read it again.
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In case of any doubts, consult a doctor or pharmacist.
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If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Venolyte and what is it used for
• 2. Important information before using Venolyte
• 3. How to use Venolyte
• 4. Possible side effects
• 5. How to store Venolyte
• 6. Package contents and other information

1. What is Venolyte and what is it used for

Venolyte is a solution for infusion.
Venolyte is used to treat:
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extracellular dehydration (water loss);
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hypovolemia (sudden decrease in circulating blood volume);
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mild metabolic acidosis (increased blood acidity caused by metabolic disorders).

2. Important information before using Venolyte

When not to use Venolyte:

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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 should not be used if the patient:

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is over-hydrated (has too much 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 enough blood through the body);
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has severe kidney function disorders;
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has metabolic alkalosis (decreased blood acidity caused by metabolic disorders);
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has hyperkalemia (high potassium levels in the blood).
The doctor will check if the above situations apply to the patient.

When to exercise special caution when using Venolyte:

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if the patient has heart failure;
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if the patient has severe heart rhythm disorders;
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if the patient has kidney function disorders;
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if the patient has severe electrolyte disorders (e.g., high potassium, sodium, magnesium, or chloride levels);
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if the patient has high blood pressure;
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if the patient has preeclampsia (a complication during pregnancy, mainly characterized by high blood pressure and significant proteinuria);
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if the patient has aldosteronism (characterized by high blood pressure and low potassium levels, caused by an excess of the hormone aldosterone);
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if the patient is taking other treatments or has symptoms related to sodium retention in the body (e.g., corticosteroids/steroids);
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if the patient is taking potassium-sparing diuretics (used to increase urine volume, such as amiloride, spironolactone, triamterene, used as monotherapy or in combination with other medicines);
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if the patient has significant potassium deficiency;
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if the patient has taken large doses of digitalis (a medicine used to treat heart conditions);
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if the patient has myasthenia (a disease characterized by significant muscle weakness);
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if the patient has recently undergone surgery and has been given a muscle relaxant (a medicine that blocks nerve-muscle conduction);
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in case of using large volumes of this solution.

Warnings and precautions

Before starting to use Venolyte, the patient should discuss it with their doctor, pharmacist, or nurse.

Children and adolescents

There are no special warnings or precautions.

Venolyte and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Venolyte is not recommended if the patient is taking:
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corticosteroids/steroids or carbenoxolone (a medicine used to treat gastrointestinal ulcers), as their use is associated with sodium and water retention in the body (fluid accumulation in tissues and increased blood pressure);
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potassium-sparing diuretics (used to increase urine volume, such as amiloride, spironolactone, triamterene, used as monotherapy or in combination with other medicines);
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angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists (medicines used mainly to control blood pressure and treat heart failure);
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tacrolimus and cyclosporin (medicines that prevent transplant rejection);
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muscle relaxants;
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salicylates (medicines used to relieve pain and reduce fever);
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lithium (an antidepressant medicine);
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medicines with an alkaline reaction, such as sympathomimetics (e.g., amphetamine).

Venolyte with food and drink

There is no data on the negative impact of concurrent use with food and drink.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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.
If another medicine has been added to Venolyte, its properties and use during pregnancy and breastfeeding should be considered separately. The doctor will discuss this with the patient.

Driving and using machines

Venolyte does not affect the ability to drive or use machines.

3. How to use Venolyte

Venolyte is administered in a hospital 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 on the appropriate dose for the patient.

Using a higher dose of Venolyte than recommended

It is unlikely that the patient will receive a higher dose than they should, as this medicine is administered by a doctor or nurse who monitors the patient's condition during treatment. However, the patient should inform their doctor or nurse about any doubts.
In case of accidental overdose, the administration of the medicine will be stopped, and the patient will be monitored for signs related to the medicine. Treatment may be necessary to remove excess fluid.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Venolyte can cause side effects, although not everybody gets them.
Very common (occurring in more than 1 in 10 patients)
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over-hydration (too much fluid in the body) and heart failure in patients with heart disease or pulmonary edema (fluid accumulation in the lungs).
Common (occurring in more than 1 in 100 patients, but less than 1 in 10 patients)
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dilution of blood components and decreased hematocrit (the proportion of blood volume occupied by red blood cells), especially after administration of a large volume of this solution.
Other side effects:
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fluid accumulation in tissues (edema);
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fever;
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infection at the infusion site, local pain, or reaction;
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vein irritation, venous thrombosis (blood clot formation), or phlebitis (inflammation of the vein) extending from the infusion site;
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extravasation (fluid leakage from the vein).
The doctor or nurse will monitor the patient during the use of this medicine. If any of these side effects occur, the treatment will be stopped.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Venolyte

Do not store in the refrigerator or freeze.
The medicine should be stored out of sight and reach of 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 given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Venolyte contains

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The active substances of 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 COO
34.0 mmol/l
Theoretical osmolality:
286.5 mOsm/l
Buffer capacity:
 2.5 mmol NaOH/l
pH:
6.9 – 7.9
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The other ingredients of the medicine are: water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).

What Venolyte looks like and what the package contains

Venolyte is a clear and colorless solution packaged in a flexible, welded, plastic bag of the freeflextype or in a plastic KabiPac bottle.
The solution is available in 500 ml or 1000 ml packages.
Polyolefin bags (freeflex) in protective packaging with foil: 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 package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized for marketing in the Member States of the European Economic Area under the following names:

Belgium
Bulgaria
Czech Republic
Croatia
Cyprus
France
Greece
Spain
Netherlands
Ireland
Malta
Poland
Portugal
Romania
Slovakia
Slovenia
Hungary
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Italy
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Date of last revision of the leaflet:09.12.2019
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Information intended exclusively for healthcare professionals:
Dosage
Adult patients, children, and adolescents
The dose and rate of infusion depend on the patient's age, weight, clinical condition, and biological parameters (including acid-base balance) and on concomitant therapy.
Recommended doses
The maximum daily dose corresponds to the patient's needs for fluids and electrolytes. For temporary blood volume replacement, it is necessary to administer a volume 3- to 5-fold greater than the lost blood volume.
Recommended dose in typical cases
Adult patients, elderly patients, and adolescents (12 years and older): 500 ml to 3 liters/24 hours.
Infants, young children, and children (from 28 days to 11 years): 20 ml/kg body weight to 100 ml/kg body weight/24 hours.
Rate of administration
In long-term treatment of adult patients, except for 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 the rate varies depending on age: infants 6 to 8 ml/kg body weight/hour, young children 4 to 6 ml/kg body weight/hour, school-age children 2 to 4 ml/kg body weight/hour.
Method of administration
For intravenous administration.