Atenativ 1000 IU, powder and solvent for solution for infusion
SpainTable of Contents
Package leaflet: Information for the user
Introduction
ATENATIV 500 IU, powder and solvent for solution for infusion.
Antithrombin III human plasma-derived
ATENATIV 1000 IU, powder and solvent for solution for infusion.
Antithrombin III human plasma-derived
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if such adverse effects are not listed in this leaflet. See section 4.
Leaflet contents:
- What Atenativ is and what it is used for
- What you need to know before using Atenativ
- How to use Atenativ
- Possible side effects
- How to store Atenativ
- Contents of the pack and other information
1. What Atenativ is and what it is used for
Atenativ is a medicine called an antithrombotic (anticoagulant) which contains antithrombin isolated from human plasma. Antithrombin is a normal component of human plasma and an important inhibitor of blood coagulation.
Atenativ is used to treat patients with congenital (inherited) antithrombin deficiency, particularly to prevent the formation and progression of blood clots in deep veins (deep vein thrombosis) and embolisms (thromboembolism) in clinical risk situations (for example, during surgery or childbirth), and in association with heparin if necessary.
2. What you need to know before using Atenativ
Do not use Atenativ:
If you are allergic to antithrombin III or to any of the components of this medicine (listed in section 6).
Warnings and precautions:
Inform your doctor if you have any other medical conditions.
Talk to your doctor, pharmacist, or nurse before starting to use Atenativ.
Viral safety
When medicines are manufactured from human blood or plasma, certain measures are implemented to prevent infections from being transmitted to patients. These include careful selection of blood and plasma donors to ensure that individuals at risk of carrying infections are excluded, testing of each donation and pooled plasma for signs of viruses/infections, and inclusion of steps in the manufacturing process that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of transmitting infections cannot be completely ruled out. This also applies to unknown or emerging viruses and other types of infections.
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, as well as against the non-enveloped hepatitis A virus. However, the measures may have limited effectiveness against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection can be severe in pregnant women (fetal infection) and in individuals with compromised immune systems or with anemia (e.g., sickle cell disease or hemolytic anemia).
It is strongly recommended that each time you receive a dose of Atenativ, the name and batch number of the medicine be recorded to maintain a record of the batch used.
- Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive antithrombin products derived from human plasma.
Other medicines and Atenativ:
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
The anticoagulant effect of heparin increases with treatment using Atenativ, and the risk of bleeding may increase. If you have an increased risk of bleeding, concomitant administration of heparin should be carefully evaluated. If your doctor decides you should receive heparin, you will be closely monitored through laboratory tests.
Atenativ with food and drink:
No effects have been observed.
Pregnancy, breastfeeding, and fertility:
Consult your doctor or pharmacist before using this medicine if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant.
There is only limited information available on the safety of using Atenativ during pregnancy or breastfeeding. Atenativ should only be used during pregnancy and breastfeeding if considered necessary due to the high risk of thromboembolism in patients with congenital antithrombin deficiency.
Driving and using machines:
No effects on the ability to drive or operate machinery have been observed. However, you are solely responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks requiring high concentration.
Important information about some of the components of Atenativ
This medicine contains 36 mg (Atenativ 500) or 72 mg (Atenativ 1000) of sodium (a main component of table/cooking salt) in each vial. This corresponds to 1.8% or 3.6% of the maximum daily sodium intake recommended for an adult.
3. How to use Atenativ
Treatment should be initiated under the supervision of a physician specialized in the treatment of patients with antithrombin deficiency.
Your doctor will decide whether you need Atenativ and at what dose. The dose should be individualized for each patient, taking into account family history related to thromboembolic episodes, actual clinical risk factors, and laboratory tests. Appropriate laboratory tests will be performed to monitor treatment.
Atenativ is administered as an infusion by healthcare professionals.
If you use more Atenativ than you should:
Symptoms of overdose have not been reported with Atenativ.
If you forget to use Atenativ:
Your doctor is responsible for supervising optimal administration and for maintaining your laboratory values within the specified ranges.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The use of plasma-derived products may cause allergic or hypersensitivity reactions (for example, swelling of the eyes or face, burning or stinging at the infusion site, fever, chills, urticaria (hives), nausea, vomiting, dyspnea, headache, dizziness, vertigo, difficulty breathing, wheezing, changes in blood pressure, palpitations, lethargy, restlessness, back pain, sweating, tingling, or even shock).
If an allergy or hypersensitivity reaction is suspected with the symptoms listed above, administration must be stopped immediately. Your doctor will follow applicable guidelines for the treatment of shock.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
For information on viral safety, see section 2.
5. Storage of Atenativ
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (between 2°C and 8°C). Keep the vials in the outer packaging to protect them from light.
Do not freeze.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Do not use Atenativ if you notice that the solution is cloudy or contains any residue.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Atenativ:
The active substance is human plasma-derived antithrombin III (50 IU/mL).
The other components are:
- Powder: sodium chloride, human albumin acetylated with tryptophan, caprylic acid.
- Solvent: water for injections.
Appearance of the product and contents of the pack
Atenativ is a powder and solvent for solution for infusion. The pack contains a lyophilized powder in a vial (type II glass) and a solvent (water for injections) in a vial (type I glass), which is used to reconstitute the powder. The resulting solution is normally clear or slightly opalescent. The reconstituted solution contains 50 IU of human antithrombin III per mL of infusion solution.
Atenativ is available in two pack sizes: 500 IU or 1000 IU.
Marketing Authorization Holder
OCTAPHARMA S.A.
Avda. Castilla, 2. (P.E. San Fernando) Ed. Dublín, 2nd Floor
28830 San Fernando de Henares, Madrid
Manufacturer:
OCTAPHARMA AB.
Lars Forssells gata 23
SE-112 75 Stockholm
Sweden
Date of the most recent review of this summary: February 2020
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/
This information is intended for healthcare professionals only:
INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS:
Dosage:
In congenital deficiency, the dose should be individualized for each patient, taking into account family history of thromboembolic episodes, actual clinical risk factors, and laboratory tests.
The number of antithrombin units administered is expressed in International Units (IU), related to the current WHO standard for antithrombin. Antithrombin activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to the international standard for antithrombin in plasma).
One International Unit of antithrombin III is equivalent to the amount of antithrombin III present in 1 mL of normal human plasma. This concentration corresponds to 100%. Administration of 1 IU of Atenativ per kg of body weight increases antithrombin III activity by approximately 1%.
The initial dose is calculated using the following formula:
Required units (IU) = body weight (kg) × [desired level (%) – actual antithrombin III level (%)]
The antithrombin activity to be initially achieved depends on the clinical situation. When antithrombin replacement is indicated, the dose should be sufficient to reach the desired antithrombin activity and to maintain an effective level. The dose should be determined and monitored according to analytical data on antithrombin activity, which should be performed at least twice daily until the patient is stabilized, and thereafter once daily, preferably immediately before the next infusion. Dose adjustments should take into account both laboratory evidence of increased antithrombin turnover and the patient's clinical evolution. Antithrombin activity should be maintained above 80% throughout the entire treatment period, unless clinical data indicate a different effective level.
The usual initial dose in congenital deficiency is 30–50 IU/kg.
Subsequently, the dose, frequency, and duration of treatment should be adjusted according to biological data and clinical status.
There are insufficient data to recommend administration of this product in children under 6 years of age.
Instructions for correct administration of the preparation:
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The lyophilized powder must be reconstituted with the recommended solvent (water for injections).
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Atenativ is compatible and may also be reconstituted with isotonic sodium chloride solution (9 mg/mL) and isotonic glucose solution (50 mg/mL) in glass infusion bottles as well as in plastic containers.
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The maximum reconstitution time is 5 minutes. Once reconstituted, the preparation should be used as soon as possible and always within 12 hours.
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Any unused solution must be discarded.
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Do not use solutions that are cloudy or contain particulate matter.
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The Atenativ solution should be reconstituted as indicated above and administered slowly by intravenous infusion (maximum rate: 300 IU/minute).