Nuwiq 500unit powder and solvent for solution for injection vials
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Summary of Product characteristics
(SPC)
29-06-2018
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Active ingredient:
Simoctocog alfa
Available from:
Octapharma Ltd
INN (International Name):
Simoctocog alfa
Dosage:
500unit
Pharmaceutical form:
Powder and solvent for solution for injection
Administration route:
Intravenous
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02110000; GTIN: 5060237670594
Summary of Product characteristics
OBJECT 1
NUWIQ POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 23-May-2018 | Octapharma
Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Nuwiq 250 IU powder and solvent for solution for injection.
Nuwiq 500 IU powder and solvent for solution for injection.
Nuwiq 1000 IU powder and solvent for solution for injection.
Nuwiq 2000 IU powder and solvent for solution for injection.
Nuwiq 2500 IU powder and solvent for solution for injection.
Nuwiq 3000 IU powder and solvent for solution for injection.
Nuwiq 4000 IU powder and solvent for solution for injection.
2. Qualitative and quantitative composition
Nuwiq 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 250 IU contains approximately 100 IU/ml of human coagulation
factor VIII (rDNA), simoctocog
alfa after reconstitution.
Nuwiq 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 500 IU contains approximately 200 IU/ml of human coagulation
factor VIII (rDNA), simoctocog
alfa after reconstitution.
Nuwiq 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 1000 IU contains approximately 400 IU/ml of human coagulation
factor VIII (rDNA), simoctocog
alfa after reconstitution.
Nuwiq 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 2000 IU contains approximately 800 IU/ml of human coagulation
factor VIII (rDNA), simoctocog
alfa after reconstitution.
Nuwiq 2500 IU powder and solvent for solution fo
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