Prolastin-C alpha1- proteinase inhibitor (human) 1000 mg powder for injection vial with diluent vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Alpha-1-proteinase inhibitor, Quantity: 1000 mg

Available from:

Grifols Australia Pty Ltd

INN (International Name):

Alpha-1-proteinase inhibitor

Pharmaceutical form:

Diluent, not applicable

Composition:

Excipient Ingredients:

Administration route:

Intravenous Infusion

Units in package:

Single vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PROLASTIN-C is an alpha-1-proteinase inhibitor (human, Alpha1-PI) indicated to increase serum Alpha1-PI levels in adults with congenital deficiency of alpha-1 antitrypsin and with clinically significant emphysema (FEV1 less than 80%). The data for clinical efficacy of PROLASTIN-C is derived from changes in the biomarkers alpha-1 anti-protease level and CT lung density. Efficacy on FEV1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials. Clinical trials have only included patients who were not smoking.

Product summary:

Visual Identification: Clear, colorless and practically free of particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2016-11-10

Patient Information leaflet

Consumer Medicine Information
PROLASTIN C
ALPHA-1-PROTEINASE INHIBITOR (HUMAN)
1,000 milligrams, Powder for Reconstitution for Injection
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using PROLASTIN-C
(prō-‘lǎs-tĭn).
This leaflet answers some common questions about PROLASTIN-C, a
prescription
medicine. It does not contain all the available information. It does
not take the place
of talking to your doctor.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
PROLASTIN-C against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR.
Keep this leaflet with you. You may need to read it again.
WHAT PROLASTIN C IS USED FOR
PROLASTIN-C is used to treat Alpha1-PI Deficiency. This is a genetic
disorder. It is
characterised by very low amounts of your own alpha-1-proteinase
inhibitor protein
(Alpha
1
-PI) in your lungs. Some patients develop a serious lung disease
called
emphysema.
PROLASTIN-C contains human Alpha
1
-PI manufactured from blood products.You
take PROLASTIN-C to boost Alpha
1
-PI in your bloodstream and lungs.
One of the reasons your lungs have been damaged is because you lack
enough of
Alpha
1
-PI. Other causes include smoking and infections. Alpha
1
-PI inhibits enzymes
that break down lung tissue. Be aware that there are no medical
studies in people to
prove that taking PROLASTIN-C over a long period of time will stop or
slow down the
symptoms of emphysema.
1
BEFORE YOU USE PROLASTIN C
_WHEN YOU MUST NOT USE IT _
Do not use PROLASTIN-C if you know you lack immunoglobulin A (IgA) in
your
bloodstream and your body has made its own antibodies against IgA. You
could have
a bad allergic reaction to PROLASTIN-C because it contains trace
amounts of IgA.
Smoking is not recommended during your treatment with PROLASTIN-C
If you are not sure whether you should use PROLASTIN-C, talk to your
doctor
_BEFORE YOU START TO USE IT _
Tell your doctor if:
•
You are pregnant or intend to become pre

Summary of Product characteristics

PROLASTIN
®
-C Alpha -Proteinase Inhibitor (Human) Registered Product Information
Page 1 of 11
1
NAME OF THE MEDICINE
Prolastin
®
-C [Alpha
1
-Proteinase Inhibitor (Human)], 1000 milligrams, powder for injection,
vial with diluent vial
CAS: 9041-92-3
DESCRIPTION
PROLASTIN-C, is a sterile, white to beige-colored, lyophilised powder
of Alpha-1-proteinase
inhibitor (Alpha
1
-PI). PROLASTIN-C is produced from pooled human plasma using
purification by polyethylene glycol (PEG) precipitation, anion
exchange chromatography,
and cation exchange chromatography.
The specific activity of PROLASTIN-C is ≥ 0.7 mg functional Alpha
1
-PI per mg of total
protein. PROLASTIN-C has a purity of ≥ 90% Alpha
1
-PI (Alpha
1
-PI protein/total protein).
Each vial contains approximately 1,000 mg of functionally active Alpha
1
-PI as determined by
capacity to neutralize porcine pancreatic elastase. When reconstituted
with 20 mL of Sterile
Water for Injection, PROLASTIN-C has a pH of 6.6–7.4, a sodium
content of 100–210 mM, a
chloride content of 60–180 mM and a sodium phosphate content of
13–25 mM.
PROLASTIN-C contains no preservative and must be administered by the
intravenous
route.
PROLASTIN-C is prepared from pooled human plasma collected from donors
in the USA.
The PROLASTIN-C manufacturing process includes several steps (Cold
Ethanol
Fractionation, PEG Precipitation, and Depth Filtration) that are
important for purifying
Alpha
1
-PI as well as removing potential virus contaminants. Two additional
steps,
Solvent/Detergent Treatment and 15 nm Virus Removal Nanofiltration,
are included in the
process as dedicated pathogen reduction steps. The Solvent/Detergent
Treatment step
effectively inactivates enveloped viruses (such as human
immunodeficiency virus type 1
[HIV-1], vesicular stomatitis virus [VSV], hepatitis B virus [HBV],
hepatitis C virus [HCV], and
West Nile virus [WNV]). The 15 nm Virus Removal Nanofiltration step
has been
implemented to reduce the risk of transmission of enveloped and
non-enveloped viruses as
small