Gammaplex: Package Insert and Label Information (Page 4 of 4)

17 PATIENT COUNSELING INFORMATION

Inform patients to immediately report the following signs and symptoms to their healthcare professional:

Inform patients that GAMMAPLEX 10% is made from human plasma and may contain infectious agents that can cause disease. While the risk that GAMMAPLEX 10% can transmit an infection has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating or removing certain viruses during manufacturing, patients should report any symptoms that concern them [see Warnings and Precautions (5.9)].

Inform patients that GAMMAPLEX 10% can interfere with their immune response to live viral vaccines (e.g. measles, mumps, and rubella), and instruct patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations [see Drug Interactions (7)].

Instruct patients to immediately report symptoms of thrombosis. These symptoms may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.

Manufactured by:
Bio Products Laboratory Ltd.,
Elstree,
WD6 3BX.
United Kingdom.
U.S. License No. 1811

U.S. Distributor:
BPL Inc.,
302 E. Pettigrew Street,
Suite C-190,
Durham, NC 27701
U.S.A.

GSUS7PI

PRINCIPAL DISPLAY PANEL — 50 mL Bottle Label

NDC 64208-8235-1

Immune Globulin Intravenous (Human)
solution for infusion

Gammaplex ® 10%

5 g

  • For intravenous use only
  • Directions for use:
    Read enclosed package insert
    before use. Use immediately
    after piercing cap

  • Do not freeze
  • Do not use unless clear and free
    from deposit

  • Maximum infusion rate 0.08 mL/kg per minute
  • Store between 2°C and 25°C
    (35.6°F and 77°F) protected from light

Rx only
50 mL

Distributor: BPL USA, Inc., 302 E. Pettigrew Street,
Suite C-190, Durham, NC 27701 USA

Manufactured by: Bio Products Laboratory Ltd.,
Elstree, WD6 3BX. U.K.
U.S. License No. 1811GSCUS2L

PRINCIPAL DISPLAY PANEL -- 50 mL Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mL Bottle Carton

NDC: 64208-8235-5

Immune Globulin
Intravenous (Human)Gammaplex® 10%

5 g

solution for infusion

For intravenous use only

Rx only

1 vial

50 mL

Bio Products Laboratory

PRINCIPAL DISPLAY PANEL -- 50 mL Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mL Bottle Label

NDC 64208-8235-2

Immune Globulin Intravenous (Human) solution for infusion

Gammaplex ® 10%

10 g

  • For intravenous use only
  • Directions for use:
    Read enclosed package insert
    before use. Use immediately
    after piercing cap

  • Do not freeze
  • Do not use unless clear and free
    from deposit

  • Maximum infusion rate 0.08 mL/kg per minute
  • Store between 2°C and 25°C
    (35.6°F and 77°F) protected from light

Rx only
100 mL

Distributor: BPL USA, Inc., 302 E. Pettigrew Street,
Suite C-190, Durham, NC 27701 USA

Manufactured by: Bio Products Laboratory Ltd.,
Elstree, WD6 3BX. U.K.
U.S. License No. 1811GSAUS2L

PRINCIPAL DISPLAY PANEL -- 100 mL Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mL Bottle Carton

NDC: 64208-8235-6

Immune Globulin
Intravenous (Human)Gammaplex® 10%

10 g

solution for infusion

For intravenous use only

Rx only

1 vial

100 mL

Bio Products Laboratory

PRINCIPAL DISPLAY PANEL -- 100 mL Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mL Bottle Label

NDC: 64208-8235-3

Immune Globulin Intravenous (Human) solution for infusion

Gammaplex ® 10%

20 g

  • For intravenous use only
  • Directions for use:
    Read enclosed package
    insert before use. Use
    immediately after piercing cap

  • Do not freeze
  • Do not use unless clear
    and free from deposit

  • Maximum infusion rate 0.08 mL/kg
    per minute
  • Store between 2°C and 25°C
    (35.6°F and 77°F) protected
    from light

Rx only
200 mL

Distributor: BPL USA, Inc., 302 E. Pettigrew Street,
Suite C-190, Durham, NC 27701 USA

Manufactured by: Bio Products Laboratory Ltd.,
Elstree, WD6 3BX. U.K.
U.S. License No. 1811GSBUS2L

PRINCIPAL DISPLAY PANEL -- 200 mL Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mL Bottle Carton

NDC: 64208-8235-7

Immune Globulin
Intravenous (Human)Gammaplex® 10%

20 g

solution for infusion

For intravenous use only

Rx only

1 vial

200 mL

Bio Products Laboratory

PRINCIPAL DISPLAY PANEL -- 200 mL Bottle Carton
(click image for full-size original)
GAMMAPLEX human immunoglobulin g solution
Product Information
Product Type Item Code (Source) NDC:64208-8235
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN IMMUNOGLOBULIN G (HUMAN IMMUNOGLOBULIN G) HUMAN IMMUNOGLOBULIN G 5 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
GLYCINE 0.9 g in 50 mL
POLYSORBATE 80 0.001 g in 50 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64208-8235-5 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS (64208-8235-1)
1 NDC:64208-8235-1 50 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (64208-8235-5)
2 NDC:64208-8235-6 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS (64208-8235-2)
2 NDC:64208-8235-2 100 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (64208-8235-6)
3 NDC:64208-8235-7 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS (64208-8235-3)
3 NDC:64208-8235-3 200 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (64208-8235-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125329 04/07/2017
Labeler — Bio Products Laboratory Limited (216845337)
Establishment
Name Address ID/FEI Operations
Bio Products Laboratory Limited 216845337 ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE

Revised: 05/2020 Bio Products Laboratory Limited

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