PRINCIPAL DISPLAY PANEL - 4ML VIAL LABEL
0.9% Sodium Chloride
Diluent, 4 mL
Disposable syringe for
drug diluent use with Xyntha®
Antihemophilic Factor (Recombinant)
Sterile, nonpyrogenic.
Contains no preservatives.
Manufactured for:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
Manufactured by:
Vetter Pharma-Fertigung GmbH & Co. KG
88212 Ravensburg, Germany
Pfizer
Rx only
US Govt. License No. 3
LOT:
EXP:
PAA034338
PRINCIPAL DISPLAY PANEL - 250 IU - LABEL
250 IU RANGE
xyntha®
Antihemophilic Factor (Recombinant),
Plasma/Albumin-Free
No Preservatives. Single Use.
Store in a refrigerator at 2° to 8°C (36° to 46°F).
See Package Insert for room temperature storage information, reconstitution instructions,
and complete information on dosage and directions for use. Protect from light.
For Factor VIII
Replacement
NDC 58394-112-01
Manufactured by:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
US Govt. License No. 3
Pfizer
Rx only
POT.: I.U.
LOT:
EXP.:
PAA034300
PRINCIPAL DISPLAY PANEL - 250 IU - TRAY LABEL
250 IU RANGE
xyntha®
Antihemophilic Factor
(Recombinant),
Plasma/Albumin-Free
For Intravenous Administration.
Rx only
Pfizer
Manufactured by:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
US Govt. License No. 3
For Factor VIII
Replacement
Therapy Only
Plasma-Free
Albumin-Free Cell Culture Process
NDC 58394-012-01
Store in a refrigerator at 2° to 8°C
(36° to 46°F).
Xyntha® may also be stored at room
temperature not to exceed 25°C (77°F) for up
to 3 months, until the expiration date. After room
temperature storage, the product can be returned
to refrigerated storage until the expiration date.
Do not store Xyntha® at room temperature and
return it to refrigerated storage more than once.
During storage, avoid prolonged exposure of
Xyntha® vial to light. Do not freeze, or damage
to the pre-filled diluent syringe may result.
Lot:
Exp.:
Pot.: I.U.
PAA034334
PRINCIPAL DISPLAY PANEL - 250 IU Carton
One single-use vial with 4 mL pre-filled diluent syringe
NDC 58394-012-01
250 IU RANGE
xyntha®
Antihemophilic Factor
(Recombinant),
Plasma/Albumin-Free
For Intravenous Administration.
Plasma-Free
Albumin-Free Cell Culture Process
For Factor VIII
Replacement
Therapy Only
Rx only
Manufactured by:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
US Govt. License No. 3
Pfizer
PRINCIPAL DISPLAY PANEL - 500 IU - LABEL
500 IU RANGE
xyntha®
Antihemophilic Factor (Recombinant),
Plasma/Albumin-Free
No Preservatives. Single Use.
Store in a refrigerator at 2° to 8°C (36° to 46°F).
See Package Insert for room temperature storage information, reconstitution instructions,
and complete information on dosage and directions for use. Protect from light.
For Factor VIII
Replacement
NDC 58394-113-01
Manufactured by:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
US Govt. License No. 3
Pfizer
Rx only
POT.: I.U.
LOT:
EXP.:
PAA034331
PRINCIPAL DISPLAY PANEL - 500 IU - TRAY LABEL
500 IU RANGE
xyntha®
Antihemophilic Factor
(Recombinant),
Plasma/Albumin-Free
For Intravenous Administration.
Rx only
Pfizer
Manufactured by:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
US Govt. License No. 3
For Factor VIII
Replacement
Therapy Only
Plasma-Free
Albumin-Free Cell Culture Process
NDC 58394-013-01
Store in a refrigerator at 2° to 8°C
(36° to 46°F).
Xyntha® may also be stored at room
temperature not to exceed 25°C (77°F) for up
to 3 months, until the expiration date. After room
temperature storage, the product can be returned
to refrigerated storage until the expiration date.
Do not store Xyntha® at room temperature and
return it to refrigerated storage more than once.
During storage, avoid prolonged exposure of
Xyntha® vial to light. Do not freeze, or damage
to the pre-filled diluent syringe may result.
Lot:
Exp.:
Pot.: I.U.
PAA034335
PRINCIPAL DISPLAY PANEL - 500 IU Carton
One single-use vial with 4 mL pre-filled diluent syringe
NDC 58394-013-01
500 IU RANGE
xyntha®
Antihemophilic Factor
(Recombinant),
Plasma/Albumin-Free
For Intravenous Administration.
Plasma-Free
Albumin-Free Cell Culture Process
For Factor VIII
Replacement
Therapy Only
Rx only
Manufactured by:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
US Govt. License No. 3
Pfizer
PRINCIPAL DISPLAY PANEL - 1000 IU - LABEL
1000 IU RANGE
xyntha®
Antihemophilic Factor (Recombinant),
Plasma/Albumin-Free
No Preservatives. Single Use.
Store in a refrigerator at 2° to 8°C (36° to 46°F).
See Package Insert for room temperature storage information, reconstitution instructions,
and complete information on dosage and directions for use. Protect from light.
For Factor VIII
Replacement
NDC 58394-114-01
Manufactured by:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
US Govt. License No. 3
Pfizer
Rx only
POT.: I.U.
LOT:
EXP.:
PAA034332
PRINCIPAL DISPLAY PANEL - 1000 IU - TRAY LABEL
1000 IU RANGE
xyntha®
Antihemophilic Factor
(Recombinant),
Plasma/Albumin-Free
For Intravenous Administration.
Rx only
Pfizer
Manufactured by:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
US Govt. License No. 3
For Factor VIII
Replacement
Therapy Only
Plasma-Free
Albumin-Free Cell Culture Process
NDC 58394-014-01
Store in a refrigerator at 2° to 8°C
(36° to 46°F).
Xyntha® may also be stored at room
temperature not to exceed 25°C (77°F) for up
to 3 months, until the expiration date. After room
temperature storage, the product can be returned
to refrigerated storage until the expiration date.
Do not store Xyntha® at room temperature and
return it to refrigerated storage more than once.
During storage, avoid prolonged exposure of
Xyntha® vial to light. Do not freeze, or damage
to the pre-filled diluent syringe may result.
Lot:
Exp.:
Pot.: I.U.
PAA034336
PRINCIPAL DISPLAY PANEL - 1000 IU Carton
One single-use vial with 4 mL pre-filled diluent syringe
NDC 58394-014-01
1000 IU RANGE
xyntha®
Antihemophilic Factor
(Recombinant),
Plasma/Albumin-Free
For Intravenous Administration.
Plasma-Free
Albumin-Free Cell Culture Process
For Factor VIII
Replacement
Therapy Only
Rx only
Manufactured by:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
US Govt. License No. 3
Pfizer
PRINCIPAL DISPLAY PANEL - 2000 IU -LABEL
2000 IU RANGE
xyntha®
Antihemophilic Factor (Recombinant),
Plasma/Albumin-Free
No Preservatives. Single Use.
Store in a refrigerator at 2° to 8°C (36° to 46°F).
See Package Insert for room temperature storage information, reconstitution instructions,
and complete information on dosage and directions for use. Protect from light.
For Factor VIII
Replacement
NDC 58394-115-01
Manufactured by:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
US Govt. License No. 3
Pfizer
Rx only
POT.: I.U.
LOT:
EXP.:
PAA034333
PRINCIPAL DISPLAY PANEL - 2000 IU - TRAY LABEL
2000 IU RANGE
xyntha®
Antihemophilic Factor
(Recombinant),
Plasma/Albumin-Free
For Intravenous Administration.
Rx only
Pfizer
Manufactured by:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
US Govt. License No. 3
For Factor VIII
Replacement
Therapy Only
Plasma-Free
Albumin-Free Cell Culture Process
NDC 58394-015-01
Store in a refrigerator at 2° to 8°C
(36° to 46°F).
Xyntha® may also be stored at room
temperature not to exceed 25°C (77°F) for up
to 3 months, until the expiration date. After room
temperature storage, the product can be returned
to refrigerated storage until the expiration date.
Do not store Xyntha® at room temperature and
return it to refrigerated storage more than once.
During storage, avoid prolonged exposure of
Xyntha® vial to light. Do not freeze, or damage
to the pre-filled diluent syringe may result.
Lot:
Exp.:
Pot.: I.U.
PAA034337
PRINCIPAL DISPLAY PANEL - 2000 IU Carton
One single-use vial with 4 mL pre-filled diluent syringe
NDC 58394-015-01
2000 IU RANGE
xyntha®
Antihemophilic Factor
(Recombinant),
Plasma/Albumin-Free
For Intravenous Administration.
Plasma-Free
Albumin-Free Cell Culture Process
For Factor VIII
Replacement
Therapy Only
Rx only
Manufactured by:
Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc
Philadelphia, PA 19101
US Govt. License No. 3
Pfizer
