Antithrombin Iii Nf Takeda

Leaflet attached to the packaging: information for the user

Antithrombin III NF Takeda, 50 IU/ml, powder and solvent for solution for infusion
human antithrombin III derived from plasma

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

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

Table of contents of the leaflet

• 1. What is Antithrombin III NF Takeda and what is it used for
• 2. Important information before using Antithrombin III NF Takeda
• 3. How to use Antithrombin III NF Takeda
• 4. Possible side effects
• 5. How to store Antithrombin III NF Takeda
• 6. Contents of the packaging and other information

1. What is Antithrombin III NF Takeda and what is it used for

Antithrombin III NF Takeda comes in the form of a pale yellow to pale green powder or substance with a solvent for solution for infusion.
Antithrombin III NF Takeda is available in packages containing:

• 500 IU of antithrombin III and 10 ml of solvent or
• 1000 IU of antithrombin III and 20 ml of solvent

Antithrombin III NF Takeda belongs to the pharmacotherapeutic group called anticoagulants.
Antithrombin III NF Takeda is used to treat congenital or acquired antithrombin III deficiency, where acquired deficiency may occur in the course of many clinical disorders.

2. Important information before using Antithrombin III NF Takeda

When not to use Antithrombin III NF Takeda

• if the patient is allergic to antithrombin III or any of the other ingredients of this medicine (listed in section 6)
• in patients with heparin-induced thrombocytopenia (i.e. decreased platelet count) in their medical history

Warnings and precautions

Identifiability
In order to improve the identifiability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

• The doctor should be informed if the first symptoms of an allergic reaction occur (e.g. hives, including generalized, chest tightness, wheezing, low blood pressure, and anaphylactic shock). Severe symptoms may require emergency treatment.
• The doctor should be informed if the patient is taking or has recently taken heparin-containing medications (e.g. for thrombosis treatment), as the effect of antithrombin is significantly enhanced by heparin.
• Antithrombin III NF Takeda is produced from human plasma. When administering drugs obtained from human blood or plasma, it is not possible to completely exclude the transmission of infectious agents. This also applies to pathogens that are not yet known. However, the risk of transmitting infectious agents is reduced through careful selection of donors and plasma, testing of plasma banks, and virus inactivation/removal procedures.

Children

This medicine should not be used in children under 6 years of age, as its safety and efficacy have not been established in this age group.

Antithrombin III NF Takeda and other medicines

The doctor should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The doctor should be informed about any heparin-containing medications (e.g. for thrombosis treatment) the patient is currently taking or has recently taken, as the effect of antithrombin is significantly enhanced by heparin.

Pregnancy, breastfeeding, and fertility

The doctor should be informed if the patient is pregnant or breastfeeding. The doctor will decide whether it is possible to use Antithrombin III NF Takeda during pregnancy or 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.

Driving and using machines

Although no effect on the ability to drive and use machines has been observed, such an effect cannot be ruled out. Therefore, it is recommended that the patient does not drive or operate machines without prior consultation with their doctor.

Antithrombin III NF Takeda contains sodium

500 IU/10 ml
The medicine contains 37.7 mg of sodium (the main component of common salt) in each vial, which corresponds to 1.9% of the WHO-recommended maximum daily sodium intake of 2 g for adults.
1000 IU/20 ml
The medicine contains 75.5 mg of sodium (the main component of common salt) in each vial, which corresponds to 3.8% of the WHO-recommended maximum daily sodium intake of 2 g for adults.

3. How to use Antithrombin III NF Takeda

Antithrombin III NF Takeda will be administered under medical supervision only. The dose will depend on the patient's body weight and individual needs. The doctor will determine the dose to be administered. Antithrombin III NF Takeda will be administered by intravenous infusion.

Using a higher dose of Antithrombin III NF Takeda than recommended

No symptoms of antithrombin overdose have been reported.

Missing a dose of Antithrombin III NF Takeda

Not applicable.

Stopping the use of Antithrombin III NF Takeda

Not applicable.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects observed after the introduction of Antithrombin III NF Takeda to the market include hypersensitivity, anaphylactic reaction, shivering, and flushing.

• Hypersensitivity or allergic reactions, such as: angioedema, burning and stinging at the infusion site, chills, flushing, generalized hives, headache, itching rash, low blood pressure, drowsiness, nausea, anxiety, rapid heartbeat, feeling of chest tightness, tingling, vomiting, wheezing, were rarely observed, but may in some cases develop into a severe anaphylactic reaction (including shock).
• Fever has been observed in rare cases.
• In rare cases, thrombocytopenia (i.e. decreased platelet count) may occur, which is mediated by heparin-induced antibodies. A decrease in platelet count below 100,000/µl or a decrease in platelet count by 50% has been observed.

If any of the side effects worsen or if any side effects not listed in this leaflet occur, the doctor should be informed.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Website: https://smz.ezdrowie.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 Antithrombin III NF Takeda

Store the medicine out of sight and reach of children.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month.
Do not use this medicine if the solution is cloudy or contains sediment.
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 packaging and other information

What Antithrombin III NF Takeda contains

• The active substance of the medicine is human antithrombin III derived from plasma
• The other ingredients are glucose, sodium chloride, disodium citrate dihydrate, and tris (hydroxymethyl) aminomethane

What Antithrombin III NF Takeda looks like and what the pack contains

Antithrombin III NF Takeda comes in the form of a powder for solution for infusion containing nominally 500 IU (or 1000 IU) of antithrombin derived from human plasma in a vial and solvent.
500 IU/10 ml
After reconstitution in 10 ml of sterile water for injection, the medicine contains approximately 50 IU/ml (500 IU/10 ml) of human antithrombin III from plasma.
1000 IU/20 ml
After reconstitution in 20 ml of sterile water for injection, the medicine contains approximately 50 IU/ml (1000 IU/20 ml) of human antithrombin III from plasma.
Antithrombin III NF Takeda is a lyophilized pale yellow or pale green powder or substance.
Each package also contains:

• 1 transfer needle
• 1 filter needle
• 1 venting needle
• 1 single-use needle
• 1 infusion set

Marketing authorization holder and manufacturer

Marketing authorization holder

Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warsaw

Manufacturer

Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna, Austria

Date of last update of the leaflet: ------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Dosing and administration

Treatment should be carried out under the supervision of a doctor with experience in treating patients with antithrombin deficiency.
Dosing
In congenital antithrombin deficiency, the dose should be individually tailored for each patient and take into account the family history of thromboembolic events, current risk factors, and laboratory results.
The dosage and duration of substitution therapy in acquired deficiency depend on the antithrombin level in plasma, the presence of symptoms of increased consumption, the cause of the disorder, and the severity of the patient's clinical condition. In each case, the dose and frequency of administration should be determined based on laboratory results and the patient's clinical condition and response to treatment.
The number of antithrombin units administered is expressed in international units (IU), which refer to the current WHO standard for antithrombin. Antithrombin activity in plasma is expressed as a percentage (relative to normal human plasma) or in international units (relative to the International Standard for antithrombin in plasma).
The activity of one international unit (IU) of antithrombin corresponds to the amount of antithrombin in one ml of normal human plasma. The calculation of the required dose of antithrombin is based on empirical data that the administration of 1 international unit (IU) of antithrombin per kilogram of body weight increases the antithrombin activity in plasma by approximately 2%.
The initial dose is calculated according to the following formula:

Required units = body weight (kg) x (Target level - current antithrombin activity [%]) x 0.5

The initial target antithrombin activity in plasma depends on the assessment of the patient's clinical condition.
After establishing the indication for antithrombin substitution, a single dose should ensure the achievement of the target antithrombin activity in plasma and then maintain its normal level. The dose administered should be determined and controlled based on antithrombin activity measurements, which should be performed at least twice a day until the patient's condition stabilizes, and then once a day, preferably shortly before the next infusion. Dose adjustment should take into account both increased antithrombin consumption and laboratory results and clinical symptoms. During treatment, antithrombin activity should be maintained above 80%, unless clinical reasons require a different, effective level.
The average initial dose in congenital deficiency is 30-50 IU/kg body weight.
Subsequently, the dose and frequency of administration, as well as the duration of treatment, should be adjusted based on laboratory results and the patient's clinical condition.
Children and adolescents
The safety and efficacy of Antithrombin III NF Takeda have not been established in children under 6 years of age. Therefore, the use of this medicine is not recommended in this patient group.
Administration
Administer intravenously. The maximum infusion rate is 5 ml/min.

Special precautions for disposal and preparation of the medicine for administration

Antithrombin III NF Takeda should be dissolved immediately before administration, as the product does not contain preservatives.
Only the provided infusion set should be used. During the preparation of the solution, aseptic techniques should be used. The prepared solution should be used immediately after preparation.
Before administration, check that the reconstituted medicine does not contain insoluble particles and has not changed color. The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain sediment.
Do not store in a refrigerator after reconstitution.
Preparing the solution:

• 1. Bring the closed vial containing the solvent (water for injection) to room temperature (max. 37°C).
• 2. Remove the protective caps from the vials with powder and solvent (Fig. A) and disinfect the rubber stoppers of both vials.
• 3. Remove the protective cap from one end of the transfer needle by twisting and pulling (Fig. B). Insert the exposed end of the needle into the rubber stopper of the vial with solvent (Fig. C).
• 4. Remove the protective cap from the other end of the transfer needle, taking care not to touch the exposed part.
• 5. Invert the vial with solvent and insert the free end of the transfer needle into the vial with powder (Fig. D). The solvent will be drawn into the vial with powder by vacuum.
• 6. Separate the two vials by pulling out the needle from the vial with powder (Fig. E). Gently shake the vial to speed up the dissolution.
• 7. After the powder has completely dissolved, insert the provided venting needle (Fig. F), and the formed foam will settle. Remove the venting needle.

Administration:

• 8. Remove the protective cap from the provided filter needle by twisting and pulling, and attach it to a sterile single-use syringe. Draw the solution into the syringe (Fig. G).
• 9. Detach the filter needle from the syringe and, after attaching the provided single-use needle (or the provided infusion set), slowly administer the solution intravenously (maximum infusion rate 5 ml/min).

If the medicine was not filtered during dissolution, a single-use infusion set with an appropriate filter should be used (maximum infusion rate: 5 ml/min).

Fig. A Fig. B
Fig. C Fig. D
Fig. E Fig. F Fig. G
Any unused medicine or waste material should be disposed of in accordance with local regulations.

Incompatibilities

The medicine should not be mixed with other medicines.

Special warnings and precautions for use

As with other protein-containing medicines administered intravenously, the administration of Antithrombin III NF Takeda may cause allergic-type hypersensitivity reactions.
Hypersensitivity and anaphylactic reactions have been reported after the introduction of Antithrombin III NF Takeda to the market. In some cases, they may develop into a severe anaphylactic reaction (including anaphylactic shock).
During infusion, patients should be closely monitored and carefully observed for any adverse reactions. The patient should be informed about early symptoms of hypersensitivity, such as: itching rash, generalized hives, chest tightness, wheezing, low blood pressure, and anaphylactic shock. If these symptoms occur after administration, the patient should contact their doctor.
In case of shock, standard treatment should be applied.
Takeda is a registered trademark of Takeda Pharmaceutical Company Limited.