ACLOTINE 100 IU/ml pdre/solv p sol inj
SYNTHESIS |
pharmacotherapeutic classification:
Hemostasis - Hematopoiesis - Hemoglobinopathies - Antithrombotics : Antithrombins ( Human Antithrombin )ATC classification:
BLOOD AND HEMATOPOIETIC ORGANS : ANTITHROMBOTICS - ANTITHROMBOTICS : HEPARIN GROUP ( ANTITHROMBIN III )Excipients:
solvent excipient: water for injection
SHAPES AND PRESENTATIONS |
COMPOSITION |
| Powder: | p 1 mL * |
| Human Antithrombin ** | 100 IU |
| (specific activity ≥ 3 IU/mg protein) | |
Solvent: water for injections.
One 5 mL vial contains 500 IU of human antithrombin.
One vial of 10 mL contains 1000 IU of human antithrombin.
* From reconstituted solution.** Produced from human donor plasma.
| DC | DIRECTIONS |
- Constitutional antithrombin deficiencies:
- in the treatment of thromboembolic accidents, in combination with heparin, when heparin used alone is ineffective;
- in the prevention of venous thrombosis in the event of a high-risk situation (in particular during surgery or pregnancy), when the risk of bleeding does not allow the use of sufficient doses of heparin.
- in the treatment of thromboembolic accidents, in combination with heparin, when heparin used alone is ineffective;
- Severe acquired deficiencies (<60%) in antithrombin.
| DC | WARNINGS AND PRECAUTIONS FOR USE |
Replacement therapy for antithrombin deficiency involves the management of the patient by a haemostasis specialist.
Clinical and biological monitoring will include in particular close monitoring of coagulation parameters in order to avoid excessive hypocoagulability.
When human antithrombin is associated with anticoagulant treatment, iterative, regular and close checks of APTT, heparinemia, or anti-Xa activity must be carried out, in particular in the minutes or hours following the infusion of human antithrombin in order to adapt the dosage of heparin. There is indeed a risk of overdose of unfractionated or low molecular weight heparin at the start of treatment with human antithrombin in patients receiving heparin.
Antithrombin levels should be measured daily in order to adapt the dosages, as prolonged treatment with unfractionated heparin may lead to a reduction in the level of circulating antithrombin.
The combination of treatment with human antithrombin with another anticoagulant used at a curative dose may put the patient at risk of bleeding when there are favorable circumstances such as: placement or presence of deep vascular access routes , recent surgery, lumbar puncture or spinal analgesia, association with other hemostasis disorders, in particular severe thrombocytopenia or hypofibrinogenemia.
- Pediatric population:
- Data from clinical trials and systematic reviews regarding the use of antithrombin III in the treatment of preterm babies for the unapproved indication of respiratory distress syndrome of newborns (RDS) suggest an increased risk of bleeding intracranial and mortality in the absence of a demonstrated beneficial effect.
- This medicine contains sodium :
- Aclotin contains sodium. This medicinal product contains approximately 0.28 mg sodium per mL of product (2.8 mg sodium per 10 mL vial, 1.4 mg sodium per 5 mL vial). At the usual doses of Aclotin, the amount of sodium provided is less than 23 mg (1 mmol of sodium), ie “sodium-free”.
- Transmissible agents:
- The usual measures to prevent the risk of transmission of infectious agents by medicinal products prepared from human blood or plasma include the clinical selection of donors, the search for specific markers of infection on each donation and on plasma pools, and as the implementation in the manufacturing process of effective steps for viral inactivation/elimination. However, when medicinal products prepared from human blood or plasma are administered, the risk of transmission of infectious agents cannot be completely excluded. This also applies to unknown or emerging viruses or other types of infectious agents.
- The measures taken are considered effective against enveloped viruses such as HIV, HBV and HCV, and against non-enveloped viruses HAV and parvovirus B19.
- Appropriate vaccination (hepatitis A and B) of patients receiving antithrombin is recommended.
At each administration of Aclotine, the name and batch number of the product mentioned on the vial must be recorded in order to maintain a link between the patient and the batch number of the drug.
| DC | INTERACTIONS |
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| DC | FERTILITY / PREGNANCY / BREASTFEEDING |
The safety of Aclotin during pregnancy and lactation has not been evaluated in controlled clinical trials. Animal experimentation is insufficient to establish safety with regard to reproduction, the course of pregnancy, the development of the embryo or fetus and peri- and postnatal development.
Therefore, Aclotine should only be prescribed during pregnancy or breastfeeding if clearly needed.
| DC | DRIVING AND USING MACHINES |
| DC | OVERDOSAGE |
No known adverse effects related to accidental overdose of Aclotin have been reported.
| PP | PRECLINICAL SAFETY |
Aclotin is not toxic by the intravenous route in a single administration in mice at a dose of 1250 IU/kg. There is no action on the arterial pressure and the heart rate of the rat, during and after the injection of Aclotin at the dose of 50 IU/kg.
Preclinical data do not suggest any mutagenic potential of Aclotin.
| DP | INCOMPATIBILITIES |
In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products.
| DP | STORAGE CONDITIONS |
- The duration of the conversation :
- 3 years.
Store at a temperature not exceeding 25°C and protected from light. Do not freeze.
After reconstitution, the product should be used immediately.
| DP | HANDLING/DISPOSAL PROCEDURES |
Respect the usual rules of asepsis.
Never use vials straight out of the refrigerator.
- Bring the two vials (powder and solvent) to a temperature not exceeding 25°C.
- Remove the protective cap from the vial of solvent (water for injections) and the vial of powder.
- Disinfect the surface of each cap.
- Remove the seal from the Mix2Vial device. Without removing the device from its packaging, snap the blue end of the Mix2Vial onto the cap of the solvent vial.
- Remove then discard the packaging. Be careful not to touch the now exposed part of the device.
- Turn the solvent vial-device assembly upside down and snap it onto the powder vial using the transparent part of the device. The solvent is automatically transferred to the powder vial. Hold the whole and shake gently, in a circular motion, to completely dissolve the product.
- Holding the reconstituted product part with one hand and the solvent part with the other, separate the vials by unscrewing the Mix2Vial device.
The dissolution thus carried out is generally instantaneous and must be complete in less than 10 minutes.
The solution is slightly opalescent. Do not use any solution with an uneven appearance or containing a deposit.
- Hold the reconstituted product vial vertically, screwing a sterile syringe onto the Mix2Vial device. Then slowly draw the product into the syringe.
- Once the product has been transferred into the syringe, hold it firmly (piston pointing down) unscrew the Mix2Vial device and replace it with an intravenous needle or an epicranial needle.
- Expel the air from the syringe and prick the vein after disinfection.
- Inject slowly intravenously or by infusion, all at once, immediately after reconstitution, without exceeding a flow rate of 4 mL/minute.
Any unused medication or waste should be disposed of in accordance with applicable regulations.
PRESCRIPTION/ISSUE/CARE |
| Medicine under hospital prescription. | |
| MA | 3400956193714 (1998, SPC rev 29.09.2021) 500 IU/5 mL. |
| 3400956193882 (1998, SPC rev 29.09.2021) 1000 IU/10 mL. | |
| Collect. | |
| Price or liability tariff (excl. VAT) per UCD: | UCD 3400892113883 (500 IU/5 mL bottle): 473.760 euros. |
| UCD 3400892113715 (1000 IU/10 mL bottle): 949,400 euros. | |
| Registered on the retrocession list with 100% support. Registered on the list of specialties covered in addition to the GHS. | |
