NOVOTHIRTEEN catridecacog (rys) 2500 IU powder for injection vial with diluent vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Catridecacog, Quantity: 5.25 mg/mL

Available from:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (International Name):

Catridecacog

Pharmaceutical form:

Drug delivery system

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

1 vial of powder for injection and one vial of diluent for resuspension with one vial adaptor

Prescription type:

Not Scheduled after consideration by Committee

Therapeutic indications:

NovoThirteen is indicated for routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.

Product summary:

Visual Identification: ; 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:

2013-11-07

Patient Information leaflet

page 1 of 5
NovoThirteen-cmiv2.doc
NOVOTHIRTEEN
®
2500 IU
catridecacog (rys)
Recombinant coagulation factor XIII
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT NOVOTHIRTEEN
® IS USED FOR
1
BEFORE YOU USE NOVOTHIRTEEN
® . 1
USING NOVOTHIRTEEN
® ................ 2
WHILE YOU ARE USING NOVOTHIRTEEN
® .................................................... 2
SIDE EFFECTS ................................. 3
STORAGE ....................................... 3
PRODUCT DESCRIPTION .................. 3
NOVOTHIRTEEN
® USER INSTRUCTIONS 4
This
leaflet
answers
some
common
questions about NovoThirteen
®
. It does
not contain all the available information.
It does not take the place of talking to
your doctor or healthcare professional.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you
using
NovoThirteen
®
against
the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
HEALTHCARE PROFESSIONAL.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NOVOTHIRTEEN
® IS
USED FOR
NovoThirteen
®
contains
the
active
substance
catridecacog,
which
is
identical
to
human
coagulation
factor
XIII, and is produced by recombinant
technology.
FXIII
is
an
enzyme
necessary for blood clotting.
NovoThirteen
®
is
used
to
prevent
bleeding in patients who are missing the
factor
XIII
(A-subunit)
protein.
NovoThirteen
®
replaces
the
missing
Factor XIII and helps to stabilise the
initial
blood
clot
by
producing
a
mesh around the clot.
ASK
YOUR
DOCTOR
OR
HEALTHCARE
PROFESSIONAL
IF
YOU
HAVE
ANY
QUESTIONS
ABOUT
WHY
NOVOTHIRTEEN
® HAS BEEN GIVEN TO
YOU.
Your
doctor
may
have
prescribed it for another reason.
BEFORE
YOU
USE
NOVOTHIRTEEN
®
_WHEN _
_NOVOTHIRTEEN_
_®_
_ _
_SHOULD NOT BE USED _
You should not use or be treated
with NovoThirteen
®
if you have an
allergy to:
•
catridecacog
or
any
of
the
ingredients listed at the end of
this leaflet
(refer to the section “Side effects”
to
look
for
signs
of
an
allergic
reaction).
IF

Summary of Product characteristics

Product Information
NovoThirteen piv3.docx
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
NOVOTHIRTEEN
® CATRIDECACOG (RYS)
1.
NAME OF THE MEDICINE
Recombinant human factor XIII (rFXIII) 2500 IU (15 mg) powder and
solvent for solution
for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NovoThirteen contains catridecacog, a recombinant coagulation factor
XIII A-subunit with a
molecular mass of approximately 83.2 kDa. Catridecacog is produced in
yeast cells
(
_Saccharomyces cerevisiae_
) by recombinant DNA technology, without the use of animal
derived materials.
One vial of NovoThirteen contains 2500 IU catridecacog per 3 mL, after
reconstitution,
corresponding to a concentration of 833 IU/mL. The specific activity
of rFXIII is
approximately 165 IU/mg protein.
The potency of this medicinal product is expressed in international
units (IU). These units are
not interchangeable with the units used to express the potency for
other FXIII-containing
products.
3.
PHARMACEUTICAL FORM
NovoThirteen is supplied as a white lyophilised powder to be
reconstituted with solvent for
injection. The solvent is clear and colourless. The reconstituted
solution has a pH of
approximately 8.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NovoThirteen is indicated for routine prophylaxis of bleeding in
patients with congenital
Factor XIII A-subunit deficiency.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be initiated and continued for a period of time under
the supervision of a
doctor experienced in the treatment of rare bleeding disorders. The
congenital factor XIII A-
subunit deficiency should be confirmed by appropriate diagnostic
procedures.
For detailed instructions for reconstitution and administration of
NovoThirteen, refer to the
Instructions for Use leaflet.
Product Information
NovoThirteen piv3.docx
Page 2 of 19
Dosage
_DOSE AND DOSE INTERVAL _
The recommended dose is 35 IU/kg body weight (bw) once monthly (every
28 days ± 2
days), administered as an intravenous bolus injection. The dose volume
in millilitre