Anbinex

PACKAGE LEAFLET: INFORMATION FOR THE USER

Anbinex
50 IU/ml; 500 IU and 1000 IU
Powder and solvent for solution for infusion.
Antithrombinum III humanum densatum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse immediately. See section 4.

Leaflet Contents:

1. What Anbinex is and what it is used for
2. Important information before using Anbinex
3. How to use Anbinex
4. Possible side effects
5. How to store Anbinex
6. Contents of the pack and other information

1. What Anbinex is and what it is used for

Anbinex is an antithrombotic medicine and belongs to the class of parenteral anticoagulants.
This medicine is used in the treatment of congenital antithrombin deficiency and in the prevention of deep vein thrombosis in the lower limbs, as well as thromboembolic changes in other blood vessels.
It may also be administered during surgical procedures and in the perioperative period if indicated. In certain cases, it may be given in combination with heparin.
Anbinex is also used in acquired antithrombin deficiency.

2. Important information before using Anbinex

When not to use Anbinex

Do not use Anbinex if the patient is allergic to antithrombin or to any of the other ingredients of this medicine (listed in section 6).
Please read the important information at the end of this section.

Warnings and precautions

Before starting treatment with Anbinex, discuss it with your doctor, pharmacist, or nurse.
As with other intravenously administered products, allergic reactions may occur. The patient should be closely monitored during infusion due to the risk of adverse reactions. If symptoms of hypersensitivity occur, including rash, generalized urticaria, chest tightness, wheezing (difficulty breathing), hypotension, or signs of anaphylaxis, the patient must immediately inform the attending physician.

In the manufacturing process of medicines derived from human blood or plasma, specific procedures are implemented to prevent transmission of infections to treated patients. These procedures include:

• careful selection of blood and plasma donors to exclude those who may be sources of infection;
• testing of each donation and pooled plasma for the presence of viruses/infectious agents;
• inclusion of steps in the plasma processing procedure that inactivate or eliminate viruses.

Despite these preventive measures, it cannot be completely excluded that infection may be transmitted when medicines derived from human blood or plasma are administered. This also applies to unknown or newly emerging viruses and other pathogens.
The preventive measures currently used are considered effective against enveloped viruses, such as human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, and non-enveloped hepatitis A virus. However, these measures may have limited effectiveness against non-enveloped viruses such as parvovirus B19.
Parvovirus B19 infection may be particularly dangerous for pregnant women (fetal infection) and for individuals with compromised immunity or suffering from certain types of anemia (e.g., sickle cell anemia, hemolytic anemia).
For patients receiving human antithrombin from plasma on a regular or repeated basis, the doctor may recommend vaccination against hepatitis A and B viruses.
It is strongly recommended that, with each administration of Anbinex, the patient's name and the product batch number be recorded to allow traceability between the patient and the medicine batch.

Anbinex and other medicines

Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Concomitant administration of antithrombin and therapeutic doses of heparin increases the risk of bleeding. The effect of antithrombin is significantly potentiated by heparin. Simultaneous administration of heparin to patients with an increased risk of bleeding should be carefully monitored both clinically and biologically.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Anbinex should be used during pregnancy and lactation only when clearly indicated. The decision should take into account the increased risk of thromboembolic events during pregnancy.

Driving and operating machinery

Anbinex has no or negligible influence on the ability to drive vehicles or operate machinery.

Anbinex contains sodium

Anbinex 500 IU contains 1.45 mmol (33.35 mg) of sodium in 10 ml.
Anbinex 1000 IU contains 2.90 mmol (66.7 mg) of sodium in 20 ml.
This should be taken into consideration for patients on a low-sodium diet.

3. How to use Anbinex

The Anbinex medication is prepared for intravenous infusion by a doctor or nurse.
Use in children and adolescents
Due to insufficient data, the use of Anbinex is not recommended in children under 6 years of age.
Frequency of administration
The doctor will determine the frequency of Anbinex administration and the intervals between doses.
Duration of treatment
The doctor will determine the duration of treatment with Anbinex.
If you are given more Anbinex than recommended
No cases of overdose have been reported.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
In rare cases, increased body temperature and allergic or anaphylactic reactions such as facial flushing, rash, increased or decreased blood pressure, tachycardia (accelerated heart rate), chills, wheezing, and oedema have been observed, as well as generalized reactions (including chest pain, fever, headache, nausea and/or vomiting), which in some cases led to the development of severe anaphylactic reactions (including shock).
Increased body temperature has been observed in rare cases.

Table of adverse reactions:
The frequency of occurrence was assessed using the following criteria:

• Very common (> 1/10),
• Common (> 1/100, < 1/10),
• Uncommon (> 1/1000, < 1/100),
• Rare (> 1/10 000, < 1/1000),
• Very rare (< 1/10 000),
• Frequency not known (frequency cannot be determined from available data)

You should inform your doctor if any of these symptoms occur.
Information on precautions against transmission of infectious agents – see section 2.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet,
you should inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions
of the 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]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions enables continuous monitoring of the benefit-risk balance of the medicinal product.
5. How to store Anbinex
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the label. The expiry date refers to the last day of the stated month.
Do not store above 30°C. Do not freeze.
After reconstitution:
Stability studies indicate a shelf life of up to 12 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately after reconstitution, the solution may be stored for no longer than 24 hours at 2°C–8°C, provided that the person responsible for storage ensures sterility during preparation.
The solution should be clear and slightly opalescent.
Do not use this medicine if clumps or precipitate are observed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Anbinex contains
The active substance is human antithrombin.
The vial with powder contains 500 IU or 1000 IU of human antithrombin.
After reconstitution, the product contains 50 IU/mL (500 IU/10 mL or 1000 IU/20 mL) of human antithrombin.
The other ingredients are: D-mannitol, sodium chloride and sodium citrate.
The pre-filled syringe contains 10 mL or 20 mL of water for injections.
For more information on excipients, see section 2.

What Anbinex looks like and contents of the pack
The pack contains a vial with a white, hygroscopic, friable solid substance or powder, and a pre-filled syringe with water for injections.
Each Anbinex 500 IU pack contains one vial with 500 IU of human antithrombin (powder for solution for infusion) and one pre-filled syringe with 10 mL of water for injections (diluent).
Each Anbinex 1000 IU pack contains one vial with 1000 IU of human antithrombin (powder for solution for infusion) and one pre-filled syringe with 20 mL of water for injections (diluent).
Each Anbinex pack includes a reconstitution kit containing a vial adapter and a microfilter.

Marketing Authorisation Holder and Manufacturer
Instituto Grifols, S.A.
Poligono Levante, c/Can Guasch, 2
Parets del Vallès
08150 Barcelona, SPAIN

For further information, please contact the local representative of the Marketing Authorisation Holder.
Grifols Polska Sp. z o.o.
Ul. Grzybowska 87, 00-844 Warsaw
Tel.: +48 22 5040641

Information intended exclusively for healthcare professionals:

In congenital antithrombin deficiency, dosage and duration of treatment should be individually adjusted
for each patient based on family history including cases of thromboembolic events, currently present
clinical risk factors, and laboratory test results.
Dosage and duration of replacement therapy in acquired antithrombin deficiency depend on
plasma antithrombin levels, presence of signs indicating accelerated consumption, underlying
disease, and severity of clinical symptoms. The dose amount and frequency of administration must
always be individually adjusted for each patient, depending on clinical outcomes.
The administered antithrombin dose is expressed in international units (IU), according to
current WHO standards. Plasma antithrombin activity may be reported in percentages (relative to
activity in normal plasma) or in international units (according to the international standard for
plasma antithrombin).
One international unit (IU) of antithrombin activity corresponds to the average amount of
antithrombin present in one ml of normal human plasma. The calculation of the required antithrombin dose
is based on empirical observation that administration of 1 IU of antithrombin per kg of body weight
results in an increase of plasma antithrombin activity by approximately 1.1% to 1.6%.
The initial dose is calculated using the following formula:
Required number of units = body weight (kg) x (100 – baseline antithrombin activity (in
percent)) x 0.8
In the initial phase of treatment, the desired plasma antithrombin activity level should be established
according to the clinical situation. After determining the indication for antithrombin use, a dose
should be administered to achieve the desired antithrombin activity level, followed by maintenance
dosing to ensure therapeutic efficacy.
The dose should be calculated and monitored based on laboratory measurements of plasma
antithrombin activity. Measurements should be performed at least twice daily, and once daily
when the patient's condition stabilizes; always immediately before the next dose administration.
It should be remembered that in severe clinical conditions such as disseminated intravascular
coagulation (DIC), the half-life of antithrombin may be significantly shortened. Dose adjustments
should take into account both the rate of antithrombin consumption determined by laboratory
measurements and the clinical course. Antithrombin activity should be maintained above 80% of
normal throughout the treatment period, or appropriately adjusted if clinical symptoms suggest
that another level may be more effective.
In the treatment of congenital deficiency, the initial dose is 30–50 IU/kg body weight.
Subsequently, the dose amount, frequency of administration, and duration of treatment depend on
the biological response in the given clinical situation.

Instructions for preparation of the medicinal product for administration

1. Warm the vials to a temperature not exceeding 30°C (Figure 1).
2. Assemble the plunger into the diluent pre-filled syringe (Figure 2).
3. Remove the filter from its packaging. Remove the plastic cap from the tip of the pre-filled syringe and attach the filter (Figure 3).
4. Remove the vial adapter and connect the syringe with the attached filter (Figure 4).
5. Remove the plastic cap from the vial and disinfect the exposed rubber stopper with a suitable antiseptic (Figure 5).
6. Pierce the vial stopper with the adapter needle (Figure 6).
7. Inject all the diluent into the vial (Figure 7).
8. Gently swirl the vial until the powder is completely dissolved (Figure 8).
9. Disconnect the syringe with filter from the vial adapter. Pull back the plunger to draw in air equal to the volume of diluent. Reconnect the syringe with attached filter to the vial adapter (Figure 9).
10. Invert the vial and aspirate the solution into the pre-filled syringe (Figure 10).
11. Disconnect the syringe from the filter and vial and administer slowly intravenously at a rate not exceeding 0.08 ml/kg/min (Figure 11).

Do not retain unused product for later use.
Do not reuse the administration set.
When using an infusion set, verify its compatibility with the pre-filled syringe. Use appropriate adapters to ensure proper administration of the product.