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Rare Bleeding Disorders

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Esperoct®

antihemophilic factor (recombinant) glycopegylated-exei

Safety Data Sheet
Prescribing Information

Prior to reconstitution, Esperoct® can be stored at refrigerated temperatures (36°F to 46°F/2°C to 8°C) for up to 30 months until the expiration date stated on the carton.1 During the 30-month shelf life, Esperoct® may be kept 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 or the expiration date on the vial, whichever is earliest.

If stored at room temperature, record the date the product was removed from the refrigerator, and do not return to the refrigerator.1 Esperoct® should be stored in the original packaging to protect the vial from light.

After Reconstitution:

Reconstituted Esperoct® should be used within 4 hours of reconstitution when stored ≤86°F (30°C) or within 24 hours if stored in the refrigerator.1 Store the reconstituted product in the vial, and discard any unused reconstituted product.


Novoeight®

antihemophilic factor (recombinant)

Safety Data Sheet
Prescribing Information

Prior to reconstitution, Novoeight® and diluent (0.9% sodium chloride solution) can be stored between 36°F - 46°F (2°C - 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.2

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.2

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.2

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.2


NovoSeven® RT

coagulation Factor VIIa (recombinant)

Safety Data Sheet
Prescribing Information

Novo Nordisk does not recommend use of NovoSeven® RT when stored outside of refrigerated or controlled room temperature conditions (36°F-77°F/2°C-25°C) prior to reconstitution.3

Prior to reconstitution, store NovoSeven® RT and histidine diluent between 36°F - 77°F (2°C - 25°C). Unreconstituted NovoSeven® RT stored between 36°F-77°F (2°C - 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.3

After Reconstitution:

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.3


Rebinyn®

coagulation Factor IX (recombinant), glycoPEGylated

Safety Data Sheet
Prescribing Information

Prior to reconstitution, Rebinyn® and diluent (10mM histidine solution) can be stored between 36°F - 46°F (2°C - 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.4

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.4

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.4

After Reconstitution:

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.4


Tretten®

coagulation Factor XIII A-subunit (recombinant)

Safety Data Sheet
Prescribing Information

Novo Nordisk does not recommend use of Tretten® when stored outside of refrigerated conditions (36°F - 46°F/2°C - 8°C) prior to reconstitution.5

Prior to reconstitution, Tretten® and diluent (Sterile Water for Injection) should be stored between 36°F - 46°F (2°C - 8°C). Unreconstituted Tretten® stored between 36°F - 46°F (2°C - 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.5

After Reconstitution:

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.5


References

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

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