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Zemaira

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Zemaira

ZEMAIRA™
ALPHA1-PROTEINASE INHIBITOR (HUMAN)
AVENTIS BEHRING L.L.C. Kankakee,Illinois 60901,U.S.A.

Zemaira

DRUG DESCRIPTION

Alpha1-Proteinase Inhibitor (Human), Zemaira™, is a sterile, stable, lyophilized preparation of highly purified human alpha1-proteinase inhibitor (A1-PI), also known as alpha1-antitrypsin, derived from human plasma. Zemaira™ is manufactured from large pools of human plasma by cold ethanol fractionation according to a modified Cohn process followed by additional purification steps.

Zemaira (alpha-proteinase inhibitor human) is supplied as a sterile, white, lyophilized powder to be administered by the intravenous route. The specific activity of Zemaira (alpha-proteinase inhibitor human) is ≥0.7 mg of functional A1-PI per milligram of total protein. The purity is ≥90% A1-PI. Following reconstitution with 20 mL of Sterile Water for Injection, U.S.P., each vial contains approximately 1000 mg of functionally active A1-PI, 81 mM sodium, 38 mM chloride, 17 mM phosphate, and 144 mM mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH. Zemaira (alpha-proteinase inhibitor human) contains no preservatives.

Each vial of Zemaira (alpha-proteinase inhibitor human) contains the labeled amount of functionally active A1-PI in milligrams as stated on the vial label as determined by its capacity to neutralize human neutrophil elastase.

The plasma used in the manufacture of this product has been tested and found to be nonreactive to HBsAg, nonreactive for antibody to Hepatitis C Virus (Anti-HCV), and negative for antibody to Human Immunodeficiency Virus (Anti-HIV-1/HIV-2).

Two viral reduction steps are employed in the manufacture of Zemaira (alpha-proteinase inhibitor human) : pasteurization at 60°C for 10 hours in an aqueous solution with stabilizers and two sequential ultrafiltration steps. These viral reduction steps have been validated in a series of in vitro experiments for their capacity to inactivate/remove Human Immunodeficiency Virus (HIV), Hepatitis A Virus (HAV), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV) as a model virus for HCV, Canine Parvovirus (CPV) as a model virus for Parvovirus B19, and Pseudorabies Virus (PRV) as a nonspecific model virus to cover a wide range of physiochemical properties of the viruses studied. Total mean log10 reductions range from 6.8 to >12.2 log10 as shown in Table 1.

Table 1: Mean (cumulative) virus reduction factors

 

Mean Reduction Factor

Mean Reduction Factor

Cumulative Reduction

 

Pasteurization

Two Ultrafiltration

Factor [log10]

 

[log10]

Steps [log10]

 

HIV-1

≥ 6.7

≥ 5.5

≥ 12.2

BVDV

≥ 5.9

5.1

≥ 11.0

PRV

4.3

≥ 6.9

≥ 11.2

HAV

≥ 5.4

≥ 6.3

≥ 11.7

CPV

(0.9)

6.8

6.8

What are the possible side effects of alpha 1-proteinase inhibitor (Aralast, Aralast NP, Prolastin, Zemaira)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • chest pain, severe headache, buzzing in your ears, uneven heartbeats;
  • fast heart rate;
  • problems with vision; or
  • fever, chills, runny nose, skin rash, and joint pain.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Zemaira »

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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