Source: Medicines Authority (MT) Revision Year: 2020 Publisher: Kedrion S.p.A. Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca)
EMOCLOT 1000 IU/10 ml, powder and solvent for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for infusion. The medicinal product is a white or pale yellow, hygroscopic powder or friable solid. |
Human plasma coagulation Factor VIII, freeze dried.
Each vial contains nominally 1000 IU of human coagulation factor VIII.
EMOCLOT contains approximately 1000 IU/ 10 ml of human coagulation factor VIII after reconstitution.
EMOCLOT is presented as a powder and solvent for solution for infusion containing nominally:
| EMOCLOT 1000 IU/10 ml | |
|---|---|
| human plasma coagulation factor VIII 1000 IU/vial | |
| human plasma coagulation factor VIII reconstituted with water for injections | 100 IU/ ml (1000 IU/10 ml) |
| solvent volume | 10 ml |
The potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
The specific activity of EMOCLOT is approximately 80 IU/mg protein.
Produced from the plasma of human donors.
This preparation contains human von Willebrand factor.
Excipient(s) with known effect: this medicinal product contains up to 41 mg sodium per vial of 10 ml.
For a full list of excipients, see paragraph 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Coagulation factor VIII |
Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X (factor Xa). Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. |
| List of Excipients |
|---|
|
Vial of powder: Tribasic sodium citrate Vial of solvent: Water for injections |
One neutral type I glass vial with type I elastomer stopper containing the powder; one neutral type I glass vial with type I elastomer stopper containing the solvent; a non pyrogenic, sterile, disposable set consisting of a medical device for reconstitution, a syringe for injection and a butterfly needle with PVC tube.
EMOCLOT 1000 IU/10 ml Powder and solvent for solution for infusion. One vial of powder + one vial of solvent + set for reconstitution and administration.
Kedrion S.p.A. Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca)
EMOCLOT 1000 IU/10 ml powder and solvent for solution for infusion + set for reconstitution and administration: MA128/00202
Date of first authorisation: 5th April 2007
Date of latest renewal: 1st February 2012
| Drug | Countries | |
|---|---|---|
| EMOCLOT | Ecuador, Croatia, Malta, Poland, Romania, Tunisia, Turkey |
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