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Novoeight®
NovoSeven® RT
Rebinyn® RT
Tretten® RT

Novoeight®

antihemophilic factor (recombinant)

Prior to reconstitution, Novoeight® and diluent (0.9% sodium chloride solution) can be stored between 36ºF-46°F (2ºC-8°C) for up to 30 months from the date of manufacture until the expiration date stated on the label. Within the 30-month period, Novoeight® may also be stored at room temperature not to exceed 86°F (30°C) for up to 12 months or up to 104°F (40°C) for no longer than 3 months.1

 

If Novoeight® is stored at room temperature, record the date the product was removed from the refrigerator in the space provided on the outer carton. At the end of the 12-month period, immediately use the product or discard it. Do not return Novoeight® to the refrigerator.1

 

Novoeight® should not be used after the expiration date stated on the vial or after the end of the 12-month period at room temperature storage. The product should be stored protected from light and should not be frozen.1

 

After Reconstitution:
Reconstituted Novoeight® may be stored at room temperature for up to 4 hours (up to 86°F/30°C), or for up to 2 hours (86°F-104°F/30°C-40°C). Store the reconstituted product in the vial. If administration does not take place immediately or within the specified 4 or 2-hour time-frame post-reconstitution, any unused reconstituted solution should not be used and should be discarded.1

 

NovoSeven® RT

coagulation Factor VIIa (recombinant)

Novo Nordisk does not recommend use of NovoSeven® RT when stored outside of refrigerated or controlled room temperature conditions (36ºF-77°F/2ºC-25°C) prior to reconstitution.2

 

Prior to reconstitution, store NovoSeven® RT and histidine diluent between 36ºF-77°F (2ºC-25°C). Unreconstituted NovoSeven® RT stored between 36ºF-77°F (2ºC-25°C) will retain biologic activity until the expiration date specified on the package label. NovoSeven® RT should not be used after the expiration date. Exposure to direct sunlight should be avoided. Do not freeze NovoSeven® RT or histidine diluent.2

 

Reconstituted NovoSeven® RT may be stored either at room temperature (up to 77°F) or refrigerated for up to 3 hours. Administration should take place immediately or within 3 hours after dissolution and any unused solution should be discarded. As indicated in the prescribing information, Novo Nordisk recommends that reconstituted NovoSeven® RT be discarded after 3 hours.2

Rebinyn®

coagulation Factor IX (recombinant), glycoPEGylated

Prior to reconstitution, Rebinyn® and diluent (10mM histidine solution) can be stored between 36ºF-46°F (2ºC-8°C) for up to 24 months from the date of manufacture until the expiration date stated on the label. Within the 24-month period, Rebinyn® may also be stored at room temperature not to exceed 86°F (30°C) for up to 6 months.3

 

If Rebinyn® is stored at room temperature, record the date the product was removed from the refrigerator in the space provided on the outer carton. At the end of the 6-month period, immediately use the product or discard it. Do not return Rebinyn® to the refrigerator.3

 

Rebinyn® should not be used after the expiration date stated on the vial or after the end of the 6-month period at room temperature storage. The product should be stored protected from light and should not be frozen.3

 

Reconstituted Rebinyn® may be stored at room temperature (up to 86°F/30°C) for up to 4 hours. Store the reconstituted product in the vial. Administration should take place immediately or within 4 hours after reconstitution and any unused solution should be discarded.3

 

Tretten®

coagulation Factor XIII A-subunit (recombinant)

Novo Nordisk does not recommend use of Tretten® when stored outside of refrigerated conditions (36ºF-46°F/2ºC-8°C) prior to reconstitution.4

 

Prior to reconstitution, Tretten® and diluent (Sterile Water for Injection) should be stored between 36ºF-46°F (2ºC-8°C). Unreconstituted Tretten® stored between 36ºF-46°F (2ºC-8°C) will retain biologic activity until the expiration date specified on the package label. Tretten® should not be used after the expiration date. The product should be stored protected from light and should not be frozen.4

 

Reconstituted Tretten® may be stored either at room temperature (up to 77°F/25°C) or refrigerated for up to 3 hours. Administration should take place immediately or within 3 hours after dissolution and any unused solution should be discarded. Reconstituted Tretten® should not be frozen or stored in syringes.4

See what to do when products are exposed to freezing or other conditions.

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References

1. Rebinyn® Prescribing Information. Plainsboro, NJ; Novo Nordisk Inc
2. Novoeight® Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
3. NovoSeven® RT Prescribing Information. Plainsboro, NJ; Novo Nordisk Inc.
4. Tretten® Prescribing Information. Plainsboro, NJ; Novo Nordisk Inc.

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