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XYNTHA® Lyophilized Powder Principal Display Panel (antihemophilic factor [Recombinant])

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 - 4ML VIAL LABEL

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 - LABEL

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 - TRAY LABEL

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 - 250 IU Carton

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 - LABEL

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 - TRAY LABEL

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 - 500 IU Carton

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 - LABEL

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 - TRAY LABEL

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 - 1000 IU Carton

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 - LABEL

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 - TRAY LABEL

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

PRINCIPAL DISPLAY PANEL - 2000 IU Carton
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