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 all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, 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.

Contents of the leaflet:

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 anticoagulant medicine and belongs to the class of parenteral anticoagulants.
This medicine is used in the treatment of congenital antithrombin deficiency, for the prevention of deep vein thrombosis in the lower limbs and thromboembolic changes in other blood vessels.
It may also be administered during surgical procedures and in the perinatal period if clinically 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 products administered intravenously, allergic reactions may occur. The patient should be closely monitored during infusion due to the risk of adverse reactions. If symptoms of hypersensitivity reactions occur, including rash, generalized urticaria, chest tightness, wheezing (difficulty breathing), hypotension or symptoms 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 during which viruses may be inactivated or removed.

Despite these preventive measures, it cannot be completely excluded that administration of medicines derived from human blood or plasma may lead to transmission of infection. This also applies to unknown or newly emerging viruses and other pathogens.
The preventive measures taken 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 weakened immunity or suffering from certain types of anemia (e.g. sickle cell anemia, hemolytic anemia).
For patients receiving repeated or regular administration of plasma-derived human antithrombin, 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, so that the patient can be linked to the batch of medicine used.

Anbinex with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used or planned for use by the patient.
Concomitant administration of antithrombin with 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 be made after considering that the risk of thromboembolic events is increased during pregnancy.

Driving and operating machinery
Anbinex has none or negligible influence on the ability to drive 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 account for patients on a low-sodium diet.

3. How to use Anbinex

Anbinex for intravenous infusion is prepared by a doctor or nurse.
Use in children and adolescents
Due to insufficient data, the use of Anbinex is not recommended in children below 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.
In case of administration of a higher than recommended dose of Anbinex
No cases of overdose have been reported.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everybody will experience them.
In rare cases, increased body temperature and allergic or anaphylactic reactions have been observed, such as facial flushing, rash, increased or decreased blood pressure, tachycardia (accelerated heart rate), chills, wheezing, and swelling, 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.

List of adverse reactions in tabular form.
Frequency of occurrence was assessed using the following criteria:

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

You should inform your doctor if any of these symptoms occur.
Information on safety regarding the transmission of infectious agents – see point 2.
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should tell your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 adverse reactions helps to provide more information on the safety 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 specified 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 standpoint, the product should be used immediately. If the product is not used immediately after reconstitution, it may be stored for no longer than 24 hours at 2°C–8°C, provided that the user assumes responsibility and the solution has been prepared under aseptic conditions.
The solution should be clear and slightly opalescent.
Do not use this medicine if flakes or sediment 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 of 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.
Other ingredients: D-mannitol, sodium chloride, and sodium citrate.
The prefilled syringe contains 10 mL or 20 mL of water for injections.
For more information on the ingredients, see section 2.

What Anbinex looks like and contents of the pack
The pack contains a vial with a white, hygroscopic, friable solid or powder, and a prefilled syringe with water for injections.
Each Anbinex 500 IU pack contains one vial of 500 IU human antithrombin (powder for solution for infusion) and one prefilled syringe of 10 mL water for injections (diluent).
Each Anbinex 1000 IU pack contains one vial of 1000 IU human antithrombin (powder for solution for infusion) and one prefilled syringe of 20 mL water for injections (diluent).
Each Anbinex pack includes a preparation set 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 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 deficiency, dosage and duration of treatment should be individually adjusted
for each patient according to family history regarding 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 dose of antithrombin is expressed in international units (IU), in accordance with
current WHO standards. Antithrombin activity in plasma 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 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 antithrombin activity in plasma 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 antithrombin activity level should be established based on
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 effective treatment.
The dose should be calculated and monitored based on laboratory measurements of antithrombin
activity in plasma. 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, the half-life of antithrombin
may be significantly shortened. Dose adjustments should take into account both the rate of antithrombin consumption
determined from 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 preparing the medicinal product for administration

1. Warm the vials to a temperature not exceeding 30°C (Figure No. 1).
2. Insert the plunger into the syringe containing the solvent (Figure No. 2).
3. Remove the filter from its packaging. Remove the plastic cover from the end of the syringe and attach the filter (Figure No. 3).
4. Remove the vial adapter and connect the syringe with the filter (Figure No. 4).
5. Remove the plastic cap from the vial and disinfect the exposed rubber stopper with a disinfectant (Figure No. 5).
6. Pierce the stopper of the vial with the needle of the adapter (Figure No. 6).
7. Inject all the solvent into the vial (Figure No. 7).
8. Gently shake the vial until the powder is completely dissolved (Figure No. 8).
9. Disconnect the syringe with the attached filter from the vial with adapter. Pull the plunger to draw in air equal to the volume of solvent. Reconnect the syringe with the attached filter to the vial with adapter (Figure No. 9).
10. Invert the vial and aspirate the solution into the syringe (Figure No. 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 No. 11).

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