PediGri®
PediGri® is a system that provides easy and immediate access to additional information about the quality and safety of Grifols plasma derivatives.
More than 700 million IU of AlphaNine SD have been infused worldwide over 20 years
How it's Supplied
For your patients with hemophilia B
Three convenient vial sizes with 10 mL diluent
Potency
500 IU FIX range
- Diluent size
-
10 mL
- NDC numbers
-
68516-3607-2
68516-3610-2
1000 IU FIX range
- Diluent size
-
10 mL
- NDC numbers
-
68516-3608-2
68516-3611-2
1500 IU FIX range
- Diluent size
-
10 mL
- NDC numbers
-
68516-3609-2
68516-3612-2
| Potency | Diluent size | NDC numbers |
|---|---|---|
|
500 IU FIX range |
10 mL |
68516-3607-2 |
|
1000 IU FIX range |
10 mL |
68516-3608-2 |
|
1500 IU FIX range |
10 mL |
68516-3609-2 |
- A Mix2Vial® included in every carton for easy reconstitution
- Room temperature storage for up to 1 month
*Mix2Vial® is a registered trademark of Medimop Medical Projects, Ltd., a subsidiary of West Pharmaceuticals Services, Inc.
Storage
- AlphaNine SD is stable for 3 years, up to the expiration date printed on its label, provided that the storage temperature is between 2 and 8 ˚C (36 and 46 ˚F)
- Do not freeze to prevent damage to diluent vial
- May be stored at room temperature not to exceed 30 ˚C for 1 month
- When removed from refrigeration, record the date removed on the space provided on the carton
Access to information related to each plasma donation
- Donation number
- Virus screenings at the origin
Specific information about each product lot
- Number of plasma units
- Total volume of plasma
Certificate of analysis, including:
- Plasma origin
- Virus screenings
- Biochemical characteristics of the finished product
PediGri®
PediGri® is a free service available only to healthcare professionals who are using Grifols plasma derivatives.
Reconstitution and Administration
Every package of AlphaNine SD comes with a Mix2Vial® device for easy reconstitution.
Watch the Mix2Vial® reconstitution demo:
*Mix2Vial® is a registered trademark of Medimop Medical Projects, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Administration
AlphaNine® SD (coagulation factor IX [human]) should be administered intravenously promptly following reconstitution. Administration of AlphaNine SD within 3 hours after reconstitution is recommended to avoid the potential ill effect of any inadvertent bacterial contamination occurring during reconstitution. Discard any unused contents into the appropriate safety container.
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Indication
AlphaNine® SD (coagulation factor IX [human]) is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B.
Important Safety Information
AlphaNine SD is made from human plasma. Plasma products carry a risk of transmitting infectious agents, including viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.
Incidences of thrombosis or disseminated intravascular coagulation (DIC) have been reported following administration of Factor IX Complex concentrates which contain high amounts of Factor II, VII, and X. AlphaNine SD contains low, nontherapeutic levels of Factor II, VII, and X.
Following administration in surgery patients and individuals with known liver disease, the physician should closely observe the patient for signs and symptoms of potential disseminated intravascular coagulation.
Allergic type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. The administration of plasma preparations may cause allergic reactions, mild chills, nausea or stinging at the infusion site.
Nephrotic syndrome has been reported following attempted immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors and a history of severe allergic reactions to Factor IX.
In order to minimize the possibility of thrombogenic complications, dosing guidelines should be strictly followed.
AlphaNine SD should not be administered at a rate exceeding 10 mL/ minute. Rapid administration may result in vasomotor reactions.
Please see full Prescribing Information for AlphaNine SD.