NOVOSEVEN RT eptacog alfa (activated) (bhk) 2mg powder for injection vial with pre-filled diluent syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

histidine, Quantity: 3.26 mg

Available from:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (International Name):

Eptacog alfa (activated),Histidine

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: hydrochloric acid; sodium hydroxide; water for injections

Administration route:

Intravenous

Units in package:

2mg

Prescription type:

Not Scheduled after consideration by Committee

Therapeutic indications:

NovoSeven RT is indicated for the control of bleeding and surgical prophylaxis in patients: with inhibitors to coagulation Factors VIII or IX; with congenital FVII deficiency; with Glanzmann's Thrombasthenia, who have antibodies to GPIIb-IIIa and/or HLA, and with past or present refractoriness to platelet transfusions.

Product summary:

Visual Identification: vial with clear liquid; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-05-01

Patient Information leaflet

NovoSeven
®
RT
page 1 of 8
NovoSeven RT-cmi7.docx
NOVOSEVEN
® RT
1.0MG, 2.0MG, 5.0MG AND 8.0MG
eptacog alfa (activated) (bhk)
Recombinant coagulation factor VIIa
_CONSUMER MEDICINE INFORMATION _
WHAT IS IN THIS LEAFLET
WHAT IS IN THIS LEAFLET .......................... 1
WHAT NOVOSEVEN
® RT IS USED FOR ..... 1
BEFORE YOU USE NOVOSEVEN
® RT ........ 1
USING NOVOSEVEN
® RT ........................ 2
WHILE YOU ARE USING NOVOSEVEN
® RT .............................................................. 2
SIDE EFFECTS ........................................... 2
STORAGE ................................................. 2
PRODUCT DESCRIPTION ........................... 3
INSTRUCTIONS FOR USE ........................... 4
This
leaflet
answers
some
common
questions
about
NovoSeven®
RT.
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 NovoSeven® RT 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
NOVOSEVEN
®
RT
IS
USED FOR
NovoSeven
®
RT
is
a
medicine
that
works by activating the blood clotting
system at the site of bleeding. It is
similar to the activated factor VII (7) in
human blood. NovoSeven
®
RT is made
by genetic engineering.
NovoSeven
®
RT
is
used
to
control
bleeding
episodes
and
to
prevent
excessive
bleeding
connected
with
surgery in people who have:

inhibitors
to
clotting
factors
VIII
(8) or IX (9), or

congenital FVII deficiency,

Glanzmann’s
Thrombasthenia
which
cannot
be
treated
effectively
with
platelet
transfusions.
Your doctor may want to give you
NovoSeven
®
RT for another reason.
ASK
YOUR
DOCTOR
OR
HEALTHCARE
PROFESSIONAL
IF
YOU
HAVE
ANY
QUESTIONS ABOUT WHY NOVOSEVEN
®
RT HAS BEEN GIVEN TO YOU.
BEFORE
YOU
USE
NOVOSEVEN
® RT
_WHEN _
_NOVOSEVEN_

Summary of Product characteristics

_NovoSeven RT pi8.docx _
_ _
_Page 1 of 17_
AUSTRALIAN PRODUCT INFORMATION
NOVOSEVEN
® RT (EPTACOG ALFA (ACTIVATED) (BHK))
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Eptacog alfa (activated) (bhk)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NovoSeven

RT contains activated recombinant coagulation Factor VII of
approximate molecular
mass 50K Daltons produced by genetic engineering from baby hamster
kidney cells (BHK cells). The
recombinant coagulation Factor VIIa (rFVIIa) in NovoSeven RT is
structurally very similar to human
plasma-derived activated Factor VIIa.
After reconstitution with solvent, each vial contains rFVIIa 1.0 mg/mL
(50,000 IU/mL), sodium
chloride 2.3 mg/mL, calcium chloride dihydrate 1.5 mg/mL,
glycylglycine 1.3 mg/mL, polysorbate 80
0.1 mg/mL and mannitol 25 mg/mL, sucrose 10 mg/mL, methionine 0.5
mg/mL and histidine 1.6
mg/mL.
The units of rFVIIa are international units measured with reference to
the first international standard
of FVIIa 89/688. These units should not be mistaken for units of other
coagulation factors including
FVII.
3
PHARMACEUTICAL FORM
NovoSeven RT (eptacog alfa (activated) (bhk)) is supplied as a stable,
sterile, freeze-dried white
powder in single-use vials, and solvent, for solution for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
NovoSeven RT is indicated for the control of bleeding and surgical
prophylaxis in patients:

with inhibitors to coagulation Factors VIII or IX;
_ _

with congenital FVII deficiency;
_ _

with Glanzmann's Thrombasthenia, who have antibodies to GPIIb-IIIa
and/or HLA, and with past
or present refractoriness to platelet transfusions.
_ _
_ _
4.2
D
OSE AND METHOD OF ADMINISTRATION
NovoSeven RT must be reconstituted with the sterile solvent provided
and then administered by
intravenous bolus injection over a period of 2-5 minutes.
Coagulation parameters should not be used to evaluate NovoSeven RT
effectiveness.
_DOSING IN CHILDREN _
Current clinical experience does not warrant a general differenti