Atenative 50 IU / ml Antithrombin powder for solution for infusion solution
1. What Atenative Is And What Atenative Used For
Atenativ is a so-called antithrombotic drug containing antithrombin isolated from human blood plasma. Antithrombin is a normal component of blood plasma and an important inhibitor of blood coagulation (clotting).
Atenatives 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 other ingredients of Atenative (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
- Fainting
If such symptoms occur after receiving Atenativ, contact a doctor immediately.
Virus safety
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 individual donations and plasma pools for signs of virus/infection and introducing steps in the processing of blood and plasma that can inactivate different 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, unknown viruses and other types of infections.
The measures taken are 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 individuals with a weakened immune system or condition nedbrystning of red blood cells (e.g., hemolytic anaemia).
When given Atenativ, it is recommended that the product name and batch number be registered to trace 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. Concomitant heparin treatment must be carefully considered if you have an increased risk of bleeding. If your doctor finds that you need heparin, you will be closely monitored using laboratory tests.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or healthcare professional for advice before taking Atenative. Your doctor will decide if you can use Atenativ during pregnancy or breastfeeding. 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 Atenative 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
- Seizures
- Headaches
- Dizziness
- Fatigue
- Lack of energy
- Tingling
- Restlessness
- Nausea
- Vomiting
- Abdominal pain
- Diarrhoea
- 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
- Fever
Reporting of side effects are
Talk to your doctor, pharmacist, or nurse if you get any Atenative side effects. This also applies to any side effects not mentioned in this information. You can also report side effects directly. By reporting side effects, you can help increase drug safety information.
5. How To Store Atenativ
- Keep Atenative out of 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 product’s shelf life. 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 before use is the user’s responsibility. The storage time should not exceed 12 hours at 2-8 ° C unless reconstitution has occurred under controlled and validated aseptic conditions.
- Do not use Atenative after the expiry date stated on the carton EXP. The expiration date is the last day of the specified month.
- Any new solution will be discarded according to local regulations.
- Do not use Atenative 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 that are no longer required. These measures will help to protect the environment.
6. Contents Of The Packaging And Other Information
Content Declaration
- 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
Octapharma AB
Lars Forssells gata 23
112 75 Stockholm
Tel 08-566 430 00
Customer support: 020-31 10 20
fraga@octapharma.se
Medical Products Agency
Box 26
751 03 Uppsala
Website: www.lakemedelsverket.se