50 IU / ml powder for solution for infusion solution
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.
– This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information.
See section 4.
In this leaflet you will find information about:
1. What Atenativ is and what it is used for
2. Before you use Atenativ
3. How to use Aternative
4. Possible side effects
5. How to store Atenativ
6. Contents of the packaging and other information
1. WHAT ATENATIVE IS AND WHAT IT IS USED FOR
Atenativ is a so-called antithrombotic drug, which contains antithrombin isolated from human blood plasma. Antithrombin is a normal component of blood plasma and an important inhibitor of blood coagulation (clotting).
Atenatives are used to treat and prevent blood clots in blood vessels in people with congenital or certain forms of acute antithrombin deficiency.
2. BEFORE YOU USE ATENATIV
Do not use Options
– if you are allergic to human plasma antithrombin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Atenatives contain very small amounts of other human proteins. All medicines that contain proteins injected into a vein ( intravenous administration ) can cause allergic reactions.
Early signs of hypersensitivity reaction are hives ( urticaria ), feeling of pressure in the chest, difficulty breathing, dizziness, and fainting.
If such symptoms occur after receiving Atenativ, contact a doctor immediately.
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, testing of individual donations and plasma pools for signs of virus/infection, and the introduction of steps in the processing of blood and plasma that can inactivate and separate 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 effective against enveloped viruses, such as HIV, hepatitis B, and hepatitis C virus, and for non-enveloped viruses, hepatitis A virus. The measures may be of limited value against unencapsulated viruses such as parvovirus B19. Infection of parvovirus B19 can be serious for pregnant women and for individuals with weakened immune system or condition nedbrystning of red blood cells (e.g., hemolytic anemia ).
When you are given Atenativ, it is recommended that the product name and batch number be registered to enable the tracing of the medicine used.
Your doctor may suggest vaccination against Hepatitis A and B if you are regularly / repeatedly treated with plasma-derived medicines.
Other Medicines and Alternatives
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Co-administration of heparin with antithrombin increases the risk of bleeding. If you have an increased risk of bleeding, concomitant heparin treatment must be carefully considered. If your doctor finds that you need heparin, you will be closely monitored using laboratory tests
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 healthcare professional for advice before taking this medicine. Your doctor will decide if you can use Atenativ during pregnancy or breast-feeding. Pregnancy in itself means an increased risk of blood clots.
Driving and using machines
No effects have been observed on the ability to drive and use machines.
3. HOW TO USE ATENATIVE
Your doctor will decide if you need Atenativ and in what dose. Healthcare professionals will give you Atenativ as an infusion directly into the bloodstream. You will be checked with the necessary laboratory tests during the treatment.
If you use too much Atenativ
No overdose symptoms have been reported. Your doctor will treat you appropriately if you experience any adverse effects.
If you stop using Options
Your doctor will decide when to stop the treatment, depending on laboratory values and your state of health.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Atenativ can cause side effects, although not everybody gets them.
Contact a doctor immediately if you get any of the following symptoms:
- swelling of the tongue, face, or throat
- difficulty swallowing
- hives and difficulty breathing.
- the feeling of pressure in the chest
- drop in blood pressure
This may be a sign of angioedema, hypersensitivity, or allergic reactions.
The following symptoms have been observed when using Atenativ but the frequency can not be calculated from the available data:
Anxiety, anxiety, seizures, headaches, dizziness, fatigue, lack of energy, tingling, restlessness, nausea, vomiting, abdominal pain, diarrhea, high blood pressure, low blood pressure, palpitations, cardiac arrest, bleeding, blood clots, wheezing, dermatitis, arthritis, arthritis or back pain, chest pain, injection site reactions, chills, redness , sweating and fever.
Reporting of side effects ar
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information. You can also report side effects directly to The
Medical Products Agency
751 03 Uppsala
By reporting side effects, you can help increase drug safety information.
5. HOW TO STORE ATENATIV
Keep this medicine out of the sight and reach of children.
Store at 2-8 ° C (in a refrigerator). However, storage at room temperature for one month does not affect the shelf life of the product. After this period, the medicine should not be put back in the safe and thrown away.
The reconstituted solution should be used within 12 hours.
From a microbiological point of view, the drug should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. The storage time should not exceed 12 hours at 2-8 ° C unless reconstitution has taken place under controlled and validated aseptic conditions.
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.
Any unused solution will be discarded according to local regulations.
Do not use this medicine if the solution is cloudy or contains particles.
The medicine 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
– The active ingredient is human antithrombin, 50 International Units (IU) / ml
– The other ingredients are:
Powder: Sodium chloride, human albumin, stabilized with acetyltryptophan and caprylic acid
Liquid: Water for injections
What the medicine looks like and the contents of the pack
The pack contains powder and solvent for solution for injection.
The powder for solution for injection contains 500 IU or 1000 IU antithrombin.
The reconstituted solution should be clear or slightly opalescent.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Lars Forssells gata 23
112 75 Stockholm
Tel 08-566 430 00
Customer support: 020-31 10 20