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ALBUTEIN (albumin- human injection, solution


  1. Patient Information
  2. Inform Patients To Immediately Report The Following Signs And Symptoms To Their Physician:
  3. Revised: 3/2019document Id:

Patient Information 

This product is usually given in a hospital setting.

Inform patients being treated with ALBUTEIN 5% about the risks and benefits of its use [seeAdverse Reactions(6)].

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

  • Allergic or anaphylactic type reactions [seeWarnings and Precautions(5.1)].
  • Cardiovascular overload (e.g., headache, dyspnea and jugular venous distention) [seeWarnings and Precautions(5.2)].
  • Increased blood pressure, raised venous pressure and pulmonary edema [seeWarnings and Precautions(5.2)].

Inform patients that ALBUTEIN 5% is a derivative of human plasma and may contain infectious agents that cause disease (e.g., viruses, and theoretically, the CJD agent). Inform patients that the risk that ALBUTEIN 5% may transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing the donated plasma for certain viral agents and by the inactivation and/or removal of certain viruses during the manufacturing process [seeWarnings and Precautions(5.7)].

Manufactured by:

Grifols Biologicals LLC
5555 Valley Boulevard
Los Angeles, CA 90032, U.S.A.
U. S. License No. 1694

Principal Display Panel 50 mL Vial Label

GRIFOLS

NDC 68516-5214-6

Albumin (Human) U.S.P
Albutein5%

5% 2.5 g 50 mL
Store at temperatures not exceeding 30 C.
DO NOT USE IF TURBID. DO NOT BEGIN
ADMINISTRATION MORE THAN 4 HOURS
AFTER THE CONTAINER HAS BEEN ENTERED.

Principal Display Panel     50 mL Vial Label

Principal Display Panel 50 mL Carton Label

GRIFOLS

NDC 68516-5214-5

Albumin (Human) U.S.P.
Albutein5%

Solution 2.5 g 50 mL

5%

Store at temperatures not exceeding 30 C.

Principal Display Panel     50 mL Carton Label

Principal Display Panel 250 mL Vial Label

GRIFOLS

NDC 68516-5214-3

Albumin (Human) U.S.P.
Albutein5%

5% 12.5 g 250 mL
Store at temperatures not exceeding 30 C.
DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE
THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

Principal Display Panel     250 mL Vial Label

Principal Display Panel 250 mL Carton Label

GRIFOLS

NDC 68516-5214-1

Albumin (Human) U.S.P.
Albutein5%

Solution 12.5 g 250 mL

5%

Store at temperatures not exceeding 30 C.

Principal Display Panel     500 mL Vial Label

Principal Display Panel 500 mL Vial Label

GRIFOLS

NDC 68516-5214-4

Albumin (Human) U.S.P.
Albutein5%

5% 25 g 500 mL
Store at temperatures not exceeding 30 C.
DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE
THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

Principal Display Panel     500 mL Vial Label

Principal Display Panel 500 mL Carton Label

GRIFOLS

NDC 68516-5214-2

Albumin (Human) U.S.P.
Albutein5%

Solution 25 g 500 mL

5%

Store at temperatures not exceeding 30 C.

Principal Display Panel     500 mL Carton Label
ALBUTEIN
albumin (human) injection, solution
Product Information
Product TypePLASMA DERIVATIVEItem Code (Source)NDC:68516-5214
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Albumin Human(UNII: ZIF514RVZR) (Albumin Human - UNII:ZIF514RVZR)Albumin Human12.5 g in 250 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride(UNII: 451W47IQ8X)
Sodium Caprylate(UNII: 9XTM81VK2B)
Sodium Acetyltryptophanate(UNII: 3EN9H0M2FX)
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68516-5214-11 in 1 CARTON
1NDC:68516-5214-3250 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC:68516-5214-21 in 1 CARTON
2NDC:68516-5214-4500 mL in 1 VIAL; Type 0: Not a Combination Product
3NDC:68516-5214-51 in 1 CARTON
3NDC:68516-5214-650 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10247808/15/1978
Labeler -GRIFOLS USA, LLC (048987452)
Establishment
NameAddressID/FEIBusiness Operations
Grifols Biologicals LLC092694538manufacture(68516-5214)
Establishment
NameAddressID/FEIBusiness Operations
Grifols Biologicals LLC121076871manufacture(68516-5214)
Establishment
NameAddressID/FEIBusiness Operations
Grifols Therapeutics LLC611019113manufacture(68516-5214)
Establishment
NameAddressID/FEIBusiness Operations
INSTITUTO GRIFOLS SA465562213manufacture(68516-5214)

Revised: 3/2019document Id: 

0784e631-4dc4-4201-966f-c501fc37d334Set id: 9c45986e-4e62-4f7d-971c-bec74dc4d234Version: 12Effective Time: 20190321GRIFOLS USA, LLC



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