Generic drug of the therapeutic class: Haemostasis and blood
Active ingredients: Human Antithrombin
laboratory: Labo F. Fraction Biotechn
Powder and solvent for solution for injection
Box of 1 Bottle of powder + 5 ml solvent bottle
1. Constitutional deficiencies in antithrombin:
in the treatment of thromboembolic events, in combination with heparin, when heparin, alone, is ineffective;
- in the prevention of venous thrombosis, in case of high risk situation (especially during surgery or pregnancy) when the risk of bleeding does not allow to use sufficient doses of heparin.
2. Severe acquired deficiency (<60%) in antithrombin, in severe, progressive CIVD, especially associated with a septic state.
Dosage ACLOTINE 100 IU / mL Powder and solvent for solution for injection Box of 1 vial of powder + vial of solvent of 5 ml
An international unit (IU) of human antithrombin is equivalent to the amount of antithrombin present in 1 ml of normal human plasma. The normal rate is on average 100%. The administration of 1 IU / kg of human antithrombin increases the circulating rate of about 2% in constitutional deficits, outside a period of thrombosis.
The dosage and duration of treatment depend on the severity of clinical signs and the extent of antithrombin deficiency. The dose administered and the frequency of injections should always be adjusted according to the observed clinical efficacy and antithrombin level. A circulating antithrombin level of 70% should be maintained throughout the course of treatment.
As an indication, the dosage is:
- in the constitutional deficit:
. in prophylactic treatment : 30 to 50 IU / kg, during a thromboembolic risk situation (pregnancy, surgery). The dosage and the rate of injection are adapted to the clinical and biological evolution,
. in curative treatment : 40 to 50 IU / kg every day or every 2 days in adults according to the clinical and biological evolution;
- in the acquired severe deficit:
in curative treatment : initial dose of 40 to 50 IU / kg or 100 IU / kg. Subsequent doses, frequency of injections and duration of treatment will be adapted to clinical status and biological monitoring.
Method and route of administration :
- ACLOTIN is in the form of a powder to be reconstituted extemporaneously with water for injections according to the modalities described in the paragraph instructions for use, handling and disposal.
- Inject only strictly intravenously, all at once, immediately after reconstitution, without exceeding a flow rate of 4 ml / minute.
- Do not inject solution with a non-homogeneous appearance or containing a deposit.
Allergy known to one of the components of the preparation.
Adverse effects Aclotine
- No serious adverse reactions have been reported to date with ACLOTINE. Nevertheless, there is a theoretical risk of allergic reactions such as cutaneous rash, edema or blood pressure drop.
- Rare cases of headache and moderate fever have been reported.
- On the other hand, in the absence of association with another anticoagulant, no haemorrhagic event was reported after infusion of human antithrombin, including during treatments that generated antithrombin levels greater than 200%.
- In case of an allergic or anaphylactic reaction, administration should be stopped immediately. In case of anaphylactic shock, symptomatic treatment of shock should be instituted.