Congenital factor XIII deficiency

【Product name】Corifact

[English common name]Factor XIII concentrate

[Chinese common name]Human coagulation factor XIII concentrate

[English name]

[Chinese other name]

[indications]Congenital factor XIII deficiencyThe patient's hemorrhage.

[Usage and dosage] is only for intravenous use. Formulated before use.
Initial dose
(1) 40 international units (units) per kilogram of body weight
(2) Dosage rate should not exceed 4 mL per minute
Subsequently administered
(1) The application of the recent glutathione FXIII activity level was used to guide administration, and the dosing level was maintained at 5% to 20% every 28 days (4 weeks). It is recommended that the FXIII activity level be <5% or >20%, and the patient's clinical condition should be adjusted by ±5 units per kg of drug administration.
(2) Dosing adjustments should be guided according to the specific analysis used to determine FXIII levels. Table 1 below is an overview of an example of a dose adjustment using Berichrom® activity analysis.
Preparation and preparation
(1) The storage vial is in the original box and in the refrigerator at 2-8 ° C (36-46 ° F). Do not freeze.
(2) Prepare Corifact with USG 20 mL sterile water for injection before use.
Administration
(1) Do not mix with other drugs. Administered by separate infusion lines.

[Storage]
(1) Store the Corifact in the refrigerator at 2 – 8 ° C (36 – 46 ° F). Corifact is stable for 24 months until the expiration date on the box and vial label. Within the deadline, Corifact can be stored at room temperature not exceeding 25 ° C (77 ° F) for up to 6 months.
(2) Do not put it back in the refrigerator when the product is stored at room temperature. Clearly mark the date of storage at room temperature on the label of the box.
(3) Do not use more than the expiration date on the box and vial label, or r the end of the room storage period to see which one expires first.
(4) In order to protect from light, store the vial in the original box. Do not freeze.
(5) Immediately after administration. This product does not contain preservatives. This product must be used within 4 hours of preparation. Do not put the prepared solution in the refrigerator or freeze it.

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