Aclotine – Indications, Posology, Against indications, Undesirable effects

Aclotine – Indications, Posology, Against indications, Undesirable effects
Source RESIP-BCB
ACLOTINE 100 UI/ml Powder and solvent for injectable solution Boîte of 1 powder Bottle + solvent bottle of 5 ml
Therapeutic class:   Hémostase and blood
Active ingredients:   Human Antithrombine
Statute:   Drug subjected to medical regulation
Laboratory:   Laboratory F. Biotechn Fraction

Indications

1. Constitutional deficits in antithrombine:
- in the treatments of the accidents thrombo-embolic, in partnership with heparin, when heparin, used only, is ineffective;
- in the prevention of venous thromboses, in the event of situation at the high risk (in particular at the time of a surgery or a pregnancy) when the hemorrhagic risk does not make it possible to use sufficient heparin amounts.
2. Severe deficit acquired (< 60%) in antithrombine, in the serious, evolutionary CIVD, in particular associated in a septic state.

Posology

Posology:
An international unit (UI) of antithrombine human is equivalent to the quantity of antithrombine present in 1 ml of normal human plasma. The normal level is on average of 100%. The human administration of 1 UI/kg of antithrombine increases the circulating rate from approximately 2% in the constitutional deficits, apart from one period of thrombosis.
The posology and the duration of the treatment depend on the severity of the clinical signs and the importance of the deficit in antithrombine. The administered dose and the frequency of the injections must always be adapted according to the clinical effectiveness and of the rates of antithrombine observed. A circulating rate of antithrombine of 70% must be maintained throughout all treatment.
As an indication, posology is:
- in the constitutional deficit:
. in prophylactic treatment: 30 to 50 UI/kg, at the time of a thrombo-embolic situation at the risk (pregnancy, surgery). The posology and the rate/rhythm of injection are adapted to the clinical and biological evolution,
. in curative treatment: 40 to 50 UI/kg the every day or every 2 days in the adult according to the clinical and biological evolution;
- in the severe acquired deficit:
in curative treatment: initial amount from 40 to 50 UI/kg even 100 UI/kg. The later amounts, the frequency of the injections and the duration of the treatment will be adapted at the clinical state and the biological follow-up.
Mode and route of administration:
- ACLOTINE is appeared as a powder to reconstitute extemporanément with water for injectable preparations according to the methods described in the paragraph instructions for the use, handling and elimination.
- To inject exclusively by strict intravenous way, in only once, immediately after reconstitution, without exceeding a flow of 4 ml/minute.
- Not to inject a solution presenting a nonhomogeneous aspect or containing a deposit.

Against indications

Allergy known to the one of the components of the preparation.

Undesirable effects

- No serious undesirable effect was reported to date with ACLOTINE. Nevertheless, there exists a theoretical risk of allergic reactions of cutaneous rash type, edema or falls tensionnelle.
- Rare cases of cephalgias and moderate fever were announced.
- On the other hand, in the absence of association with another anticoagulant, no hemorrhagic accident was reported after human perfusion of antithrombine, including during treatments having generated rates of antithrombine higher than 200%.
- In the event of reaction of type the allergic or anaphylactic, the administration must be stopped immediately. In the event of shock anaphylactic, the symptomatic treatment of the state of shock will have to be founded.