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FLEBOGAMMA DIF (immune globulin- human injection, solution


  1. Instruct Patients To Immediately Report The Following Signs And Symptoms To Their Physician:
  2. Lot No.:
  3. Expires:
  4. Revised: 12/2018document Id:

Instruct Patients To Immediately Report The Following Signs And Symptoms To Their Physician: 

  • Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (see Renal Failure [5.2])
  • Symptoms of thrombosis which 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 (see Thrombosis [5.4])
  • Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting (see Aseptic Meningitis Syndrome [5.5])
  • Fatigue, increased heart rate, yellowing of the skin or eyes, and dark-colored urine (see Hemolysis [5.6])
  • Trouble breathing, chest pain, blue lips or extremities, fever (see TRALI [5.7])

Inform patients that Flebogamma 5% DIF is made from human plasma and may contain infectious agents that can cause disease (e.g., viruses, the vCJD agent and, theoretically, the CJD agent). The risk of Flebogamma 5% DIF transmitting an infectious agent has been reduced by screening plasma donors for prior exposure, testing the donated plasma, and inactivating and/or removing certain viruses during manufacturing. (see Warnings and Precautions [5.8]) Instruct patients to report any symptoms that concern them and might be caused by infections.

Inform patients that Flebogamma 5% DIF may interfere with their immune response to live viral vaccines such as measles, mumps, and rubella. Inform patients to notify their health care professional of this potential interaction when they are receiving vaccinations. (see Drug Interactions [7])

Manufactured by:
INSTITUTO GRIFOLS, S.A.
BARCELONA SPAIN
U.S. License No. 1181

Principal Display Panel - Vial Label

NDC 61953-0004-6

Immune Globulin Intravenous (Human)
Flebogamma5% DIF

0.5 g in 10 mL

Rx only.

5%

Store at 2 - 25 C (36 - 77 F).

Manufactured byInstituto Grifols, S.A.
Barcelona - SPAIN
U.S. License No. 1181

3039363

Lot No.: 


Expires

Principal Display Panel - Vial Label

Principal Display Panel - Carton Label

GRIFOLS

NDC 61953-0004-3

Immune Globulin
Intravenous (Human)
Flebogamma5% DIF


Solution for infusion
5 g in 100 mL

5%

Nanofiltered (20 nm)

DO NOT USE IF TURBID. ONCE THE CONTAINER HAS BEEN ENTERED IT SHOULD BE USED PROMPTLY.

CONTENTS

One each: 100 mL vial Immune Globulin Intravenous (Human)

Each 100 mL contains 5 g Immune Globulin (Human), 5 g D-sorbitol.

Protein content is 50 g/L

Contains no preservatives.

The patient and physician should discuss the risks and benefits of this product.

INSTRUCTIONS

For information on dosage and directions for administration, see enclosed package insert.

STORE AT 2 - 25 C (36 - 77 F)

Rx only.

PRECAUTION

Do not allow to freeze.

Single dose container for intravenous administration.

Discard any unused contents and administration devices after use.

Manufactured by:
Instituto Grifols, S.A.
Barcelona - SPAIN
U.S. License No. 1181

GTIN: 00361953000432
SN: XXXXXXXXXXXXXXXX
Lot: XXXXXXXXXX
Exp.: DD-MMM-YY

3048655

100 mL carton

Principal Display Panel - Vial Label

NDC 61953-0004-9

Immune Globulin Intravenous (Human)
Flebogamma5% DIF
10 g in 200 mL

Rx only.

5%

CONTENTS: Each 200 mL contains
Immune Globulin (Human) 10 g; D-sorbitol 10 g; Protein content is 50 g/L

Dosage and directions for administration, see package insert.

Store at 2 - 25 C (36 - 77 F).

DO NOT USE IF TURBID, ONCE THE CONTAINER HAS BEEN ENTERED IT SHOULD BE USED PROMPTLY.

The patient and physician should discuss the risks and benefits of this product.

Manufactured byInstituto Grifols, S.A.Barcelona - SPAIN
U.S. License No. 1181

3039369

Expires: 

400 mL vial

Principal Display Panel - Carton Label

GRIFOLS

NDC 61953-0004-5

Immune Globulin
Intravenous (Human)
Flebogamma5% DIF


Solution for infusion
20 g in 400 mL

5%

Nanofiltered (20 nm)

DO NOT USE IF TURBID. ONCE THE CONTAINER HAS BEEN ENTERED IT SHOULD BE USED PROMPTLY.

CONTENTS

One each: 400 mL vial Immune Globulin Intravenous (Human)

Each 400 mL contains 20 g Immune Globulin (Human), 20 g D-sorbitol.

Protein content is 50 g/L

Contains no preservatives.

The patient and physician should discuss the risks and benefits of this product.

INSTRUCTIONS

For information on dosage and directions for administration, see enclosed package insert.

STORE AT 2 - 25 C (36 - 77 F)

Rx only.

PRECAUTION

Do not allow to freeze.

Single dose container for intravenous administration.

Discard any unused contents and administration devices after use.

Manufactured by:
Instituto Grifols, S.A.
Barcelona - SPAIN
U.S. License No. 1181

GTIN: 00361953000456
SN: XXXXXXXXXXXXXXXX
Lot: XXXXXXXXXX
Exp.: DD-MMM-YY

3048658

400 mL carton
FLEBOGAMMA DIF
immune globulin (human) injection, solution
Product Information
Product TypePLASMA DERIVATIVEItem Code (Source)NDC:61953-0004
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HUMAN IMMUNOGLOBULIN G(UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)HUMAN IMMUNOGLOBULIN G0.05 g in 1 mL
Inactive Ingredients
Ingredient NameStrength
SORBITOL(UNII: 506T60A25R)
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61953-0004-11 in 1 CARTON
1NDC:61953-0004-610 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC:61953-0004-21 in 1 CARTON
2NDC:61953-0004-750 mL in 1 VIAL; Type 0: Not a Combination Product
3NDC:61953-0004-31 in 1 CARTON
3NDC:61953-0004-8100 mL in 1 VIAL; Type 0: Not a Combination Product
4NDC:61953-0004-41 in 1 CARTON
4NDC:61953-0004-9200 mL in 1 VIAL; Type 0: Not a Combination Product
5NDC:61953-0004-51 in 1 CARTON
5NDC:61953-0004-0400 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12507712/21/2006
Labeler -GRIFOLS USA, LLC (048987452)
Establishment
NameAddressID/FEIBusiness Operations
Instituto Grifols, S.A.465562213MANUFACTURE(61953-0004)

Revised: 12/2018document Id: 

1f8c566e-d36b-469d-b6e0-ba2011a8b1f8Set id: 2cf22c72-64ac-45be-b7c6-d20340730096Version: 28Effective Time: 20181214GRIFOLS USA, LLC



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