Patient Information Leaflet

10% DEXTRAN 40 000 FRESENIUS, 100 mg/ml, infusion solution
Dextranum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What 10% DEXTRAN 40 000 FRESENIUS is and what it is used for
Important information before using 10% DEXTRAN 40 000 FRESENIUS
How to use 10% DEXTRAN 40 000 FRESENIUS
Possible side effects
How to store 10% DEXTRAN 40 000 FRESENIUS
Contents of the pack and other information

1. What 10% DEXTRAN 40 000 FRESENIUS is and what it is used for

10% DEXTRAN 40 000 FRESENIUS is a solution used to increase the volume of circulating blood.
The medicine is administered intravenously.
Indications:

as an adjunct in the treatment of certain types of shock, e.g., shock caused by burns, surgery, hemorrhage, or trauma;
improvement of blood properties (prevention of excessive blood viscosity);
prevention of disturbances in circulation in the smallest blood vessels (so-called microcirculation);
prevention of venous thrombosis and pulmonary embolism in patients undergoing surgical procedures;
prophylactically (anti-shock and antithrombotic) in major surgical procedures involving extracorporeal circulation, as the main fluid or as a component of the priming solution for the heart-lung apparatus.

2. Important information before using the medicinal product 10% DEXTRAN 40 000 FRESENIUS

When not to use 10% DEXTRAN 40 000 FRESENIUS
Do not use 10% DEXTRAN 40 000 FRESENIUS if the patient:

is allergic to the active substance or to any of the other ingredients of this medicinal product (listed in section 6);
has developed pulmonary edema or is at risk of developing pulmonary edema;
has edema caused by circulatory failure;
has bleeding disorders (tendency to bleed);
has thrombocytopenia (marked decrease in platelet count);
has active bleeding;
has intracerebral hemorrhage;
has severe arterial hypertension;
has renal failure with oliguria (urine output less than 500 ml/day) or anuria (urine output less than 100 ml/day);
needs to restrict sodium intake.

Warnings and precautions
During administration of the medicinal product, a mild allergic reaction may occur, with symptoms such as skin redness, urticaria, chills, or a severe allergic reaction, with symptoms such as a significant drop in blood pressure, circulatory collapse due to cardiac arrest.
During administration, anaphylactic shock may occur, with symptoms such as skin rash, itching of the palms and soles spreading throughout the body, swelling of the face, lips or throat causing breathing difficulties, wheezing, shortness of breath, undetectable pulse, significantly lowered blood pressure, sweating, cold extremities, loss of consciousness, or cardiac arrest.
Symptoms of allergic reactions most commonly occur within the first few minutes of infusion. Therefore, it is recommended that this medicinal product be administered in a hospital setting, and the patient should be monitored during and for at least 30 minutes after completion of the infusion.
If any of the above symptoms occur, the infusion must be stopped immediately and the physician should be notified to initiate appropriate treatment.
Before administering this medicinal product, the physician will assess the patient's hydration status.
After administering more than 1000 ml of dextran, a transient prolongation of bleeding time may occur (increased risk of bleeding and bruising); therefore, the physician may order special blood tests.
Administration of large volumes of dextran may reduce blood protein levels.
Use of this medicinal product may lead to circulatory overload; therefore, the physician will monitor the patient's condition.
Due to its sodium content, this medicinal product should be used with caution in patients with congestive heart failure or renal failure.

10% DEXTRAN 40 000 FRESENIUS and other medicinal products
Inform your doctor or pharmacist about all medicinal products currently used, recently used, or planned to be used.
10% DEXTRAN 40 000 FRESENIUS enhances the effects of heparin and warfarin (medicinal products used to reduce blood clotting). When heparin is used concomitantly, the physician will adjust its dose accordingly.
The following medicinal products should not be added to the dextran solution:

ε-aminocaproic acid (a medicinal product used to stop bleeding);
ampicillin (an antibiotic used to treat infections);
soluble barbiturates (medicinal products used to treat insomnia and epilepsy);
chlorpromazine (a psychotropic medicinal product used to treat schizophrenia);
chlorotetracycline (a tetracycline antibiotic used to treat infections);
vitamin C, vitamin K;
promethazine (an antihistamine medicinal product used, among others, in the treatment of allergies);
streptokinase (a medicinal product used in the treatment of myocardial infarction);
sodium cephaloridine and sodium cephalothin (cephalosporin antibiotics used to treat infections).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicinal product.
10% DEXTRAN 40 000 FRESENIUS may be administered to women during pregnancy and breastfeeding only if the physician considers it necessary.

Driving and operating machinery
This medicinal product has no influence on the ability to drive or operate machinery.

10% DEXTRAN 40 000 FRESENIUS contains sodium
1000 ml of solution contains 9 g of sodium chloride.
This should be taken into account in patients with impaired renal function and in patients controlling sodium intake in their diet.

3. How to use 10% DEKSTRAN 40 000 FRESENIUS

This medicine is administered exclusively by medical personnel. Do not use this medicine yourself. In case of
doubt, consult your doctor.
The dosage is determined individually by the doctor for each patient, depending on the indication, clinical
condition, age and body weight of the patient.
Administration of a higher than recommended dose of 10% DEKSTRAN 40 000 FRESENIUS
If a higher than recommended dose is administered, inform the doctor or nurse immediately.
Administration of a higher than recommended dose of the medicine may cause:

circulatory overload;
worsening of edema;
pulmonary edema;
prolonged clotting time;
electrolyte disturbances.

In case of any further doubts regarding the use of this medicine, consult your
doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Frequency unknown (cannot be estimated from the available data):

allergic reactions manifesting as rhinitis (nasal congestion), urticaria (pinkish, itchy skin rash), skin rash;
severe allergic reactions (anaphylactic shock) – see section 2: "Important information before using 10% Dextran 40 000 Fresenius"; symptoms usually resolve, but there have been fatal cases, particularly in elderly patients (over 65 years of age) and/or patients with circulatory failure;
anuria, especially in patients with impaired kidney function;
pulmonary edema caused by too rapid administration of the medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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
E-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continuous monitoring of the medicine's safety and helps to improve the knowledge on its safe use.

5. How to store 10% DEKSTRAN 40 000 FRESENIUS

Keep the medicine out of the sight and reach of children.
Store below 25°C. Do not freeze. The container must not be stored or reused after opening.
Any unused portion of the medicine is not suitable for further use.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What 10% DEXTRAN 40 000 FRESENIUS contains
The active substance is dextran.
1000 ml of solution contains 100 g of dextran with an average molecular weight of approximately 40,000.
The other ingredients are: sodium chloride, water for injections, 2% sodium hydroxide.

What 10% DEXTRAN 40 000 FRESENIUS looks like and contents of the pack
The medicine is a clear solution for infusion.
It is available in glass bottles, packed in cardboard boxes of 12 bottles with a volume of 250 ml or 500 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

Manufacturer
Fresenius Kabi Italia S.r.l.
Via Camagre 41
37063 Isola della Scala, Verona
Italy

For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland
Tel.: +48 22 345 67 89

Information intended exclusively for medical professionals:

Dosage and method of administration
The medicinal product is administered by intravenous infusion using an infusion set.
Dosage and infusion rate are determined by the physician according to the indication, clinical condition (blood pressure, pulse rate, hematocrit values), age and body weight of the patient.

Supportive treatment in shock to increase circulating blood volume
The daily dose on the first day should not exceed 20 ml/kg body weight. The first 500 ml may be administered as a rapid intravenous infusion. Frequent monitoring of central venous pressure is recommended during the initial phase of infusion. If central venous pressure is not monitored, the intravenous infusion should be slower, and the patient should be observed for signs of circulatory overload. If a rapid increase in central venous pressure occurs, administration of the medicinal product must be discontinued. The remaining portion of the dose may be administered by slower infusion.
The daily dose on subsequent days should not exceed 10 ml/kg body weight.
Use of the medicinal product for longer than 5 days is not recommended.

Perioperative antithrombotic prophylaxis
Dose of 500–1000 ml on the first day, followed by 500 ml on the next day.
In patients at high risk of thromboembolism, treatment may be continued at a dose of 500 ml every other day for up to 10 days.

Extracorporeal circulation
Typically 10–20 ml/kg body weight.

Overdose
Overdose may result in circulatory overload, worsening of edema, pulmonary edema, prolonged clotting time, and electrolyte disturbances. In case of excessive parenteral administration of dextran, the patient's clinical condition should be assessed and appropriate treatment initiated.

Interactions with other medicinal products and other types of interactions
10% DEXTRAN 40 000 FRESENIUS potentiates the effects of heparin and warfarin. When used concomitantly with heparin, the heparin dose should be reduced by 30–70% (synergism).

The following medicinal products must not be added to the dextran solution:
ε-aminocaproic acid, ampicillin, soluble barbiturates, chlorpromazine, chlorotetracycline, vitamin C, vitamin K, promethazine, streptokinase, sodium cefalorydine, sodium cephalothin.

As with all infusion solutions, compatibility must be verified before adding any other medicinal products to the dextran solution.

Preparation for administration
Do not use the medicinal product if cloudiness or precipitate is present.
If crystals have formed in the solution, the product should be heated in a water bath to a temperature not exceeding 100°C until the crystals are completely dissolved. The solution must then be cooled to 37°C before administration.
Only clear, transparent solutions should be used.
Any unused portion of the medicinal product is not suitable for further use.
Aseptic techniques must be observed.

Pharmaceutical incompatibilities
See section: "Interactions with other medicinal products and other types of interactions".

Storage conditions
Store below 25°C. Do not freeze.
Once opened, the container must not be reused or re-stored.

Disposal of unused medicinal product or waste
Any unused residues or waste material must be disposed of in accordance with local regulations.