PROLASTIN C LIQUID alpha-1-proteinase inhibitor (human) 500 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: 500 mg

Available from:

Grifols Australia Pty Ltd

Pharmaceutical form:

Liquid, multipurpose

Composition:

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

Administration route:

Intravenous

Units in package:

one 10 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:

2022-05-27

Patient Information leaflet

PROLASTIN
®
C LIQUID
1
Consumer Medicine Information
PROLASTIN
®
C LIQUID
PROLASTIN C LIQUID Alpha-1-proteinase inhibitor (human) 500 mg
solution for
injection for intravenous infusion vial
PROLASTIN C LIQUID Alpha-1-proteinase inhibitor (human) 1000 mg
solution for
injection for intravenous infusion vial
PROLASTIN C LIQUID Alpha-1-proteinase inhibitor (human) 4000 mg
solution for
injection for intravenous infusion vial
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using PROLASTIN
®
C (prō-‘lǎs-tĭn)
LIQUID.
This leaflet answers some common questions about PROLASTIN
®
C LIQUID, 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 LIQUID 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 LIQUID IS USED FOR
PROLASTIN
®
C LIQUID is used to treat Alpha-1-proteinase inhibitor deficiency.
This
is a genetic disorder. It is characterised by very low amounts of your
own Alpha-1-
proteinase inhibitor protein in your lungs. Some patients develop a
serious lung
disease called emphysema.
PROLASTIN
®
C LIQUID contains human Alpha-1-proteinase inhibitor manufactured
from blood products. You take PROLASTIN
®
C LIQUID to boost Alpha-1-proteinase
inhibitor in your bloodstream and lungs.
One of the reasons your lungs have been damaged is because you lack
enough of
Alpha-1-proteinase inhibitor. Other causes include smoking and
infections. Alpha-1-
PROLASTIN
®
C LIQUID
2
proteinase inhibitor inhibits enzymes that break down lung tissue. Be
aware that
there are no medical studies in people to prove that taking PROLASTIN
®
C LIQUID
over a long period of time will stop or slow down the symptoms of
emphysema.
BEFORE YOU USE PROLASTIN
®
C LIQUID
_WHEN YOU MUST NOT USE IT_

Summary of Product characteristics

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