powder and solvent for solution for injection/infusion, 
human antithrombin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read about it.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Antithrombin III Baxalta is and what it is used for 
2. What you need to know before you use Antithrombin III Baxalta 
3. How to use Antithrombin III Baxalta 
4. Possible side effects 
5. How Antithrombin III Baxalta must be stored 
6. Package contents and other information

1. What Antithrombin III Baxalta is and what it is used for

Antithrombin III Baxalta, which contains antithrombin, belongs to a group of medicines called anticoagulants . Antithrombin is a normal component of blood that reduces the blood’s ability to coagulate.

Antithrombin III Baxalta is used to treat and prevent blood clots in blood vessels in people with congenital deficiency or certain forms of acute antithrombin deficiency.

What you need to know before you use Antithrombin III Baxalta

Do not use Antithrombin III Baxalta

  • if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6.)
  • if you have previously received heparin and this has caused a decrease in the number of platelets (heparin-induced thrombocytopenia ).

Warnings and cautions

Traceability

To facilitate the traceability of biological drugs, the name and manufacturing batch number of the drug must be documented.

Antithrombin III Baxalta is made from human plasma. When medicines are made from human plasma or blood, special measures are taken to prevent the transmission of infection to patients. This includes:

a careful selection of blood and plasma donors to ensure that people at risk of being carriers are excluded, as well as testing of individual donations and plasma pools for signs of virus/infection. The manufacturers of these products also include steps in the processing of blood and plasma that can inactivate and secrete viruses.

Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infections.

The measures taken are considered to be effective against enveloped viruses, such as HIV, hepatitis B, and hepatitis C viruses, and for non-enveloped viruses, hepatitis A virus . The measures may be of limited value against unencapsulated viruses such as parvovirus B19. Parvovirus B19 infection can be serious in pregnant women ( fetal infection ), immunocompromised individuals, or in patients with certain types of anemia (eg, hemolytic anemia ).

Your doctor may suggest vaccination against Hepatitis A and B if you are regularly / repeatedly treated with plasma-derived antithrombin products.

Children

Do not give this medicine to children under 6 years of age as safety and efficacy have not yet been established.

Use of other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are using, or have recently used, medicines containing heparin(eg for the treatment of blood clots) as heparin significantly increases the effect of Antithrombin III Baxalta.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you can use Antithrombin III Baxalta during pregnancy or breast-feeding.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects (eg fatigue and low blood pressure ). Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Antithrombin III Baxalta contains sodium

500 IU / 10 ml

This medicine contains 37.7 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 1.9% of the WHO’s highest recommended daily intake (2 grams of sodium for adults).

1000 IU / 20 ml

This medicine contains 74.5 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 3.8% of the WHO’s highest recommended daily intake (2 grams of sodium for adults).

3. How to use Antithrombin III Baxalta

Antithrombin III Baxalta is given under the medical supervision of a healthcare professional.

The doctor adjusts your dose according to your body weight and your individual needs.

Antithrombin is given as an injection or infusion (a slow injection ) into a vein.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Hypersensitivity or allergic reactions have sometimes occurred. Symptoms include burning and stinging sensation at the injection/infusion site, chills, redness, headache, hives, fatigue, nausea, restlessness, rapid heartbeat, tingling, and vomiting. In some cases, this has led to severe hypersensitivity or allergic reactions (including shock ), so-called anaphylactic shock.

Contact a doctor immediately if you get any of the following symptoms of severe hypersensitivity or allergic reaction (during or after treatment):

  • swelling of the face, tongue, or throat,
  • difficulty swallowing
  • generalized urticaria and difficulty breathing
  • the feeling of pressure over the chest
  • low blood pressure

Other side effects may occur

Rare (may affect up to 1 in 1,000 people)

fever decreased platelet count

Has been reported (occurs in an unknown number of users)

tremors, hot flashes

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Antithrombin III Baxalta

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 ° C – 8 ° C). Store in the original package. Sensitive to light. Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is human plasma-derived antithrombin III. One ampoule contains nominally 500 IU and 1000 IU, respectively, of human plasma-derived antithrombin III.
    500 IU / 10 ml 
    This medicinal product contains approximately 50 IU / ml (500 IU / 10 ml) of human plasma-derived antithrombin III when reconstituted with 10 ml of sterile water for injections.
    1000 IU / 20 mlThis medicinal product contains approximately 50 IU / ml (1000 IU / 20 ml) of human plasma-derived antithrombin III when reconstituted with 20 ml of sterile water for injections.
  • The other ingredients are glucose, sodium chloride, sodium citrate dihydrate, and trometamol.
  • The diluent is sterile water for injections.

What the medicine looks like and the contents of the pack

Antithrombin III Baxalta is a lyophilized light yellow to light green brittle solid or a powder.

The solution is usually clear or slightly opalescent.

500 IU powder (antithrombin) in a glass bottle (type II) and 10 ml diluent in a glass bottle (type I).

1000 IU powder (antithrombin) in a glass bottle (type II) and 20 ml diluent in a glass bottle

(type II).

Each package also contains:

  • a transfer cannula
  • a filter needle
  • an aeration cannula
  • a disposable cannula
  • an infusion set

Marketing Authorization Holder and Manufacturer

Baxalta Innovations GmbH

Industriestrasse 67

1221 Vienna

Austria

Manufacturer

Baxter AG

Industristrasse 67

1221 Vienna

Austria

Takeda Manufacturing Austria AG

Industriestrasse 67

A-1221 Vienna

Austria

Agent

Takeda Pharma AB

Vasagatan 7, 6 tr

111 20 Stockholm

Muhammad Nadeem

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