|Pharmacotherapeutic group Description Pharmacokinetics Clinical Pharmacology Indications ContraIndications Warnings Precautions Side effects Dosage and administration Overdosage Drug interactions Patient Information How Supplied Storage conditions And Handling|
Corifact, Factor XIII Concentrate (Human), is a
heat-treated, lyophilized concentrate of coagulation factor XIII for
reconstitution for intravenous use.Corifact (FXIII) consists of two A-subunits
and two B-subunits, and is made from pooled human plasma.Each vial contains
1000-1600 units FXIII, 120 to 200 mg human albumin, 120 to 320 mg total
protein, 80 to 120 mg glucose and 140 to 220 mg sodium chloride.Sodium
hydroxide may have been used to adjust the pH.
All plasma used in the manufacture of Corifact is obtained from US donors and is tested using serological assays for hepatitis B surface antigen and antibodies to HIV-½and HCV.The plasma is tested with Nucleic Acid Testing (NAT) for HCV, HIV-1, HAV and HBV and found to be non-reactive (negative), and the plasma is also tested by NAT for Human Parvovirus B19.Only plasma that passed virus screening is used for production, and the limit for Parvovirus B19 in the fractionation pool is set not to exceed 104 International Units of Parvovirus B19 DNA per mL.
Corifact is manufactured from cryo-depleted plasma into an ethanol precipitate, which is then purified by the following four steps:
The sterile filtered final bulk solution is filled into vials and lyophilized.These four manufacturing steps were independently validated in a series of in vitro experiments for their capacity to inactivate or remove both enveloped and non-enveloped viruses.Table 2 shows the virus clearance capacity of the Corifact manufacturing process, expressed as mean log reduction factor.
Table 2: Overall Virus Inactivation/Removal in
|Manufacturing Steps||Virus Reduction Factor (log10)|
|Enveloped Viruses||Non-Enveloped Viruses|
|Al(OH)3 Adsorption / Vitacel® and Defibrination||HIV||BVDV||WNV||PRV||HAV||CPV|
|Ion Exchange Chromatography||5.0||3.3||n.d.||≥8.0||3.4||3.7|
|20 nm / 20 nm Virus Filtration||≥6.1||≥5.0||≥7.4||≥6.4||≥5.6||6.1|
|Cumulative Virus Reduction (log10)||≥18.8||≥16.4||≥14.8||≥>21.3||≥13.3||10.8|
|HIV, Human immunodeficiency virus type 1, model for HIV-1
BVDV, bovine viral diarrhea virus, model for HCV
WNV, West Nile virus
PRV, pseudorabies virus, a model for large enveloped DNA viruses
HAV, Hepatitis A virus
CPV, canine parvovirus, model for B19V
B19V, Human parvovirus B19
N/A, not applicable
n.d., not done
*Not included in the calculation of the overall virus reduction factor.
†Studies using human parvovirus B19, which are considered experimental in nature, have demonstrated a virus reduction factor of ≥4.0 log 10 by heat treatment.
|Medication Analogs Generic Name||medicines of the ATC group|