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FLEBOGAMMA DIF (immune globulin intravenous- human injection, solution


  1. Instruct Patients To Immediately Report The Following Signs And Symptoms To Their Physician:
  2. Expires:
  3. 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(seeRenal 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(seeThrombosis (5.4))
  • Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea and vomiting(seeAseptic Meningitis Syndrome (5.5))
  • Increased heart rate, fatigue, yellowing of skin or eyes and dark-colored urine(seeHemolysis (5.6))
  • Trouble breathing, chest pain, blue lips or extremities, fever(seeTRALI (5.7))

Inform patients that Flebogamma 10% 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 10% DIF transmitting an infection has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating and/or removing certain viruses during manufacturing.(seeWarnings and Precautions (5.8))Instruct patients to report any symptoms that concern them and might be caused by infections.

Inform patients that Flebogamma 10% 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.(seeDrug Interactions (7))

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

Principal Display Panel 5g Vial Label

GRIFOLS

NDC 61953-0005-4

Immune Globulin Intravenous (Human)
Flebogamma10% DIF

10%
5 g in 50 mLRx only.

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

3039373

Expires: 

Principal Display Panel - Vial Label

Principal Display Panel - Carton Label

GRIFOLS

NDC 61953-0005-3

Immune Globulin
Intravenous (Human)
Flebogamma10% DIF

Solution for infusion

20 g in 200 mL

10%

Nanofiltered (20 nm)

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

CONTENTS

One each: 200 mL vial Immune Globulin Intravenous (Human)

Each 200 mL contains 20 g Immune Globulin (Human), 10 g D-sorbitol

Protein content is 100 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: 00361953000531
SN: XXXXXXXXXXXXXXXX
Lot: XXXXXXXXXX
Exp.: DD-MMM-YY

3048661

carton-200ml-3048661
FLEBOGAMMA DIF
immune globulin intravenous (human) injection, solution
Product Information
Product TypePLASMA DERIVATIVEItem Code (Source)NDC:61953-0005
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Human Immunoglobulin G(UNII: 66Y330CJHS) (Human Immunoglobulin G - UNII:66Y330CJHS)Human Immunoglobulin G5 g in 50 mL
Inactive Ingredients
Ingredient NameStrength
sorbitol(UNII: 506T60A25R)
Polyethylene Glycol, Unspecified(UNII: 3WJQ0SDW1A)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61953-0005-11 in 1 CARTON
1NDC:61953-0005-450 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC:61953-0005-21 in 1 CARTON
2NDC:61953-0005-5100 mL in 1 VIAL; Type 0: Not a Combination Product
3NDC:61953-0005-31 in 1 CARTON
3NDC:61953-0005-6200 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12507707/27/2010
Labeler -GRIFOLS USA, LLC (048987452)
Establishment
NameAddressID/FEIBusiness Operations
Instituto Grifols, S.A.465562213manufacture(61953-0005)

Revised: 12/2018document Id: 

a4dc06fd-8a09-4fb9-ad52-bcb2b498a14bSet id: f9bf6322-75b4-4ccf-9a4b-4724203f5eefVersion: 24Effective Time: 20181214GRIFOLS USA, LLC



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