10% Dekstran 40 000 Fresenius

Package Leaflet: Information for the User

10% DEKSTRAN 40 000 FRESENIUS, 100 mg/ml, Solution for Infusion

Dextran

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is 10% DEKSTRAN 40 000 FRESENIUS and what is it used for
• 2. Important information before using 10% DEKSTRAN 40 000 FRESENIUS
• 3. How to use 10% DEKSTRAN 40 000 FRESENIUS
• 4. Possible side effects
• 5. How to store 10% DEKSTRAN 40 000 FRESENIUS
• 6. Contents of the pack and other information

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

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

• as an auxiliary in the treatment of certain types of shock, e.g. shock resulting from burns, surgical procedures, bleeding, or injury;
• to improve blood properties (prevent excessive thickening);
• to prevent circulatory disorders in the smallest blood vessels (so-called microcirculation);
• to prevent the occurrence of venous thrombosis and pulmonary embolism in patients undergoing surgical procedures;
• as a preventive measure (anti-shock and anti-thrombotic) in severe surgical procedures using extracorporeal circulation as the main fluid or a component of the fluid to fill the heart-lung machine.

2. Important information before using 10% DEKSTRAN 40 000 FRESENIUS

When not to use 10% DEKSTRAN 40 000 FRESENIUS

Do not use 10% DEKSTRAN 40 000 FRESENIUS if the patient:

• is allergic to the active substance or any of the other ingredients of this medicine (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 (significant decrease in platelet count);
• has bleeding;
• has had a cerebral hemorrhage;
• has severe hypertension;
• has renal failure with oliguria (production of less than 500 ml of urine per day) or anuria (production of less than 100 ml of urine per day);
• should limit sodium intake.

Warnings and precautions

During administration of the medicine, a mild allergic reactionmay occur, with symptoms such as skin redness, hives, chills, or a severe allergic reactionwith symptoms such as significant decrease in blood pressure, vascular collapse due to circulatory arrest.
During administration of the medicine, an anaphylactic shockmay occur, with symptoms such as skin rash, itching of the hands and feet spreading throughout the body, facial swelling, mouth or throat swelling making breathing difficult, wheezing, shortness of breath, unpalpable pulse, significantly decreased blood pressure, sweating, cold limbs, loss of consciousness, cardiac arrest.
Symptoms of an allergic reaction usually occur within the first few minutes of infusion. Therefore, it is recommended to administer this medicine in a hospital setting and to monitor the patient's condition during infusion and for at least 30 minutes after its completion.
If any of the above symptoms occur, the infusion should be stopped immediately and the doctor should be notified, who will provide appropriate treatment.
Before administering this medicine, the doctor will assess the patient's hydration status.
After administering more than 1000 ml of dextran, transient prolongation of bleeding time (increased risk of bleeding and bruising) may occur; therefore, the doctor will order special blood tests.
Administration of large volumes of dextran can lead to a decrease in blood protein levels.
During the use of this medicine, circulatory overload may occur; therefore, the doctor will monitor the patient's condition.
Due to the sodium content, this medicine should be used with caution in patients with congestive heart failure and renal failure.

10% DEKSTRAN 40 000 FRESENIUS and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
10% DEKSTRAN 40 000 FRESENIUS enhances the effect of heparin and warfarin (medicines used to reduce blood clotting). When used concomitantly with heparin, the doctor will reduce its dose accordingly.
The following medicines should not be added to the dextran solution:

• ε-aminocaproic acid (a medicine used to stop bleeding);
• ampicillin (an antibiotic used to treat infections);
• soluble barbiturates (medicines used to treat insomnia and epilepsy);
• chlorpromazine (a psychotropic medicine used to treat schizophrenia);
• chlorotetracycline (an antibiotic from the tetracycline group used to treat infections);
• vitamin C, vitamin K;
• promethazine (an antihistamine medicine used to treat allergies);
• streptokinase (a medicine used to treat myocardial infarction);
• cefaloridine sodium and cefalotin sodium (antibiotics from the cephalosporin group used to treat infections).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
10% DEKSTRAN 40 000 FRESENIUS can be administered to pregnant women and during breastfeeding only if the doctor considers it necessary.

Driving and using machines

The medicine has no effect on the ability to drive and use machines.

10% DEKSTRAN 40 000 FRESENIUS contains sodium

1000 ml of the solution contains 9 g of sodium chloride.
This should be taken into account in patients with reduced renal function and in patients controlling their sodium intake.

3. How to use 10% DEKSTRAN 40 000 FRESENIUS

This medicine is administered only by medical personnel. Do not use the medicine yourself. If you have any doubts, ask your doctor.
The dosage is determined by the doctor individually for each patient, depending on the indication, clinical condition, age, and weight of the patient.

Using a higher dose of 10% DEKSTRAN 40 000 FRESENIUS than recommended

If a higher dose of the medicine is used, tell your doctor or nurse immediately.
Using a higher dose of the medicine than recommended may cause:

• circulatory overload;
• exacerbation of edema;
• pulmonary edema;
• prolongation of bleeding time;
• electrolyte disturbances.

If you have any further doubts about using this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known(cannot be estimated from the available data):

• allergic reactions (hypersensitivity) with symptoms such as rhinitis (runny nose), urticaria (hives), skin rash;
• severe allergic reactions (anaphylactic shock) - see section 2: "Important information before using 10% DEKSTRAN 40 000 FRESENIUS"; usually these symptoms resolve, but there are cases of death, which concerned elderly patients (over 65 years) and (or) patients with circulatory failure;
• anuria, especially in patients with impaired renal function;
• pulmonary edema caused by too rapid administration of the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store 10% DEKSTRAN 40 000 FRESENIUS

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze. The packaging should not be stored and used again after opening. Unused medicine should not be used.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What 10% DEKSTRAN 40 000 FRESENIUS contains

The active substance of the medicine is dextran.
1000 ml of the solution contains 100 g of dextran with an average molecular weight of about 40,000.
The other ingredients are sodium chloride, water for injections, sodium hydroxide 2%.

What 10% DEKSTRAN 40 000 FRESENIUS looks like and contents of the pack

The medicine is a colorless solution for infusion.
It is available in glass bottles packaged in a cardboard box, 12 bottles of 250 ml or 500 ml each.
Not all pack 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 Italia S.r.l.
Via Camagre 41
37063 Isola della Scala Verona
Italy
To obtain more detailed information, contact the marketing authorization holder: Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, tel.: +48 22 345 67 89

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Dosage and administration

The medicine is administered by intravenous infusion using an infusion set.
Dosage and infusion rate are determined by the doctor, depending on the indication, clinical condition (blood pressure, heart rate, hematocrit value), age, and weight of the patient.
Auxiliary 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 can be administered by rapid intravenous infusion. Frequent monitoring of central venous pressure is recommended in the initial phase of infusion. If central venous pressure is not monitored, intravenous infusion should be slower and the patient should be observed for signs of circulatory overload.
If there is a sudden increase in central venous pressure, the administration of the medicine should be stopped.
The remaining dose can be administered by slower infusion.
The daily dose on subsequent days should not exceed 10 ml/kg body weight.
The medicine should not be used for more than 5 days.
In perioperative anti-thrombotic prophylaxis
Dose of 500-1000 ml on the first day, 500 ml on the next day.
In patients with high risk of thrombosis, treatment may be continued at a dose of 500 ml every other day for up to 10 days.
In extracorporeal circulation
Usually 10-20 ml/kg body weight.

Overdose

In case of overdose, circulatory overload, exacerbation of edema, pulmonary edema, prolongation of bleeding time, or electrolyte disturbances may occur. In case of accidental administration of an excessive amount of dextran, the patient's clinical condition should be assessed and appropriate treatment should be initiated.

Interactions with other medicines and other types of interactions

10% DEKSTRAN 40 000 FRESENIUS enhances the effect of heparin and warfarin. When used concomitantly with heparin, the dose of heparin should be reduced by 30-70% (synergism).
The following medicines should not be added to the dextran solution:
ε-aminocaproic acid, ampicillin, soluble barbiturates, chlorpromazine, chlorotetracycline, vitamin C, vitamin K, promethazine, streptokinase, cefaloridine sodium, cefalotin sodium.
Similarly, as with all infusion solutions, the compatibility of other medicines added to the dextran solution should be checked.

Preparation of the medicine for use

The medicine should not be used if it is cloudy or contains sediment.
In case of crystal formation in the solution, the medicine should be heated in a water bath to a temperature not exceeding 100°C until the crystals are completely dissolved. Before administration, the medicine should be cooled to 37°C.
Only use a clear solution.
Unused medicine should not be used.
Follow aseptic procedures.

Incompatibilities

See the section: "Interactions with other medicines and other types of interactions".

Storage conditions

Store in a temperature below 25°C. Do not freeze.
The packaging should not be stored and used again after opening.

Disposal of unused medicine

Any unused medicine or waste material should be disposed of in accordance with local regulations.