PROLASTIN C LIQUID alpha-1-proteinase inhibitor (human) 1000 mg solution for injection for intravenous infusion 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

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: monobasic sodium phosphate; alanine; water for injections

Administration route:

Intravenous

Units in package:

One 20 mL vial in one carton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PROLASTIN? C LIQUID is an Alpha-1-proteinase inhibitor indicated to increase serum Alpha-1-proteinase inhibitor levels in adults with congenital deficiency of alpha-1-antitrypsin and with clinically significant emphysema (FEV1 <80%).,The data for clinical efficacy of PROLASTIN? C LIQUID 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: The solution is clear or slightly opalescent, colourless or pale yellow or pale green or pale brown.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-07-01

Patient Information leaflet

PROLASTIN
®
C LIQUID Alpha-1-proteinase inhibitor Page 1 of 13
Product Information
AUSTRALIAN PRODUCT INFORMATION
PROLASTIN
®
C LIQUID (Alpha-1-proteinase inhibitor) Solution for Injection for
Intravenous
Infusion Vial
1
NAME OF THE MEDICINE
Alpha-1-proteinase inhibitor (human) 500 mg solution for injection for
intravenous
infusion vial
Alpha-1-proteinase inhibitor (human) 1000 mg solution for injection
for intravenous
infusion vial
Alpha-1-proteinase inhibitor (human) 4000 mg solution for injection
for intravenous
infusion vial
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROLASTIN
®
C LIQUID has a purity of ≥ 90% Alpha-1-proteinase inhibitor. Each
single-use vial contains approximately 500 mg (10 mL), 1,000 mg (20
mL), and 4,000
mg (80 mL) of functionally active Alpha-1-proteinase inhibitor as
determined by
capacity to neutralise porcine pancreatic elastase.
PROLASTIN
®
C LIQUID is prepared from pooled human plasma collected from
donors in the USA.
PROLASTIN
®
C LIQUID contains no preservative.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
PROLASTIN
®
C LIQUID is a sterile non-pyrogenic solution for injection for
intravenous infusion of Alpha-1-proteinase inhibitor. The solution is
clear or slightly
opalescent, colourless or pale yellow or pale green or pale brown.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROLASTIN
®
C LIQUID is an Alpha-1-proteinase inhibitor indicated to increase
serum Alpha-1-proteinase inhibitor levels in adults with congenital
deficiency of alpha-
1-antitrypsin and with clinically significant emphysema (FEV
1
<80%).
The data for clinical efficacy of PROLASTIN
®
C LIQUID is derived from changes in
the biomarkers alpha-1 anti-protease level and CT lung density.
Efficacy on FEV
1
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
FOR INTRAVENOU

Summary of Product characteristics

PROLASTIN
®
C LIQUID Alpha-1-proteinase inhibitor Page 1 of 12
Product Information
AUSTRALIAN PRODUCT INFORMATION
PROLASTIN
®
C LIQUID (Alpha-1-proteinase inhibitor) Solution for Injection
1
NAME OF THE MEDICINE
Alpha-1-proteinase inhibitor
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROLASTIN
®
C LIQUID has a purity of ≥ 90% Alpha-1-proteinase inhibitor. Each 20
mL single-use vial contains approximately 1,000 mg of functionally
active Alpha-1-
proteinase inhibitor as determined by capacity to neutralise porcine
pancreatic
elastase.
PROLASTIN
®
C LIQUID is prepared from pooled human plasma collected from
donors in the USA.
PROLASTIN
®
C LIQUID contains no preservative.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
PROLASTIN
®
C LIQUID is a sterile non-pyrogenic solution for injection of Alpha-1-
proteinase inhibitor. The solution is clear or slightly opalescent,
colourless or pale
yellow or pale green or pale brown.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROLASTIN
®
C LIQUID is an Alpha-1-proteinase inhibitor
indicated to increase
serum Alpha-1-proteinase inhibitor levels in adults with congenital
deficiency of alpha-
1-antitrypsin and with clinically significant emphysema (FEV
1
<80%).
The data for clinical efficacy of PROLASTIN
®
C LIQUID is derived from changes in
the biomarkers alpha-1 anti-protease level and CT lung density.
Efficacy on FEV
1
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
FOR INTRAVENOUS USE ONLY.
Treatment must be initiated and monitored by a respiratory physician,
and should be in
conjunction with other pharmacological and non-pharmacological
therapies.
To be eligible for treatment, patients must be diagnosed with
alpha-1-antitrypsin
deficiency on the basis of genotype, as well as have levels of
alpha-1-antitrypsin
< 11 µM, and clini