NovoSeven RT

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Eptacog alfa (activated) 2mg

Dostupné z:

Novo Nordisk Pharmaceuticals Ltd

INN (Medzinárodný Name):

Eptacog alfa (activated) 2 mg

Dávkovanie:

2 mg

Forma lieku:

Powder for injection with diluent

Zloženie:

Active: Eptacog alfa (activated) 2mg Excipient: Calcium chloride dihydrate Glycylglycine Mannitol Methionine Nitrogen Polysorbate 80 Sodium chloride Sucrose Histidine Water for injection

Počet v balení:

Combination pack, 1x(active+diluent), 2 mg

Trieda:

General sale

Typ predpisu:

General sale

Výrobca:

Novo Nordisk A/S

Terapeutické indikácie:

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

Prehľad produktov:

Package - Contents - Shelf Life: Combination pack, 1x(active+diluent) - 2 mg - 36 months from date of manufacture stored at or below 25°C protect from light 5 hours reconstituted stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Stored in vial 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Prepared in aseptic conditions and stored in a polypropylene syringe - Syringe, glass, diluent, Type 1 glass - 2.1 mL - 48 months from date of manufacture stored at or below 25°C 36 months from date of manufacture stored at or below 30°C - Vial, glass, active - 2 mg -   - Vial, glass, diluent - 2.1 mL -  

Dátum Autorizácia:

2008-01-03

Príbalový leták

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_

Súhrn charakteristických

- 1 -
NEW ZEALAND DATASHEET
1 PRODUCT NAME
NOVOSEVEN
®
RT
1.0 mg, 2.0 mg, 5.0 mg, 8.0 mg powder and solvent for solution for
injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
NovoSeven RT 1 mg (50 KIU)
NovoSeven RT is presented as powder and solvent for solution for
injection containing 1 mg
eptacog alfa (activated) per vial (corresponds to 50 KIU/vial).
NovoSeven RT 2 mg (100 KIU)
NovoSeven RTis presented as powder and solvent for solution for
injection containing 2 mg
eptacog alfa (activated) per vial (corresponds to 100 KIU/vial).
NovoSeven RT 5 mg (250 KIU)
NovoSeven RT is presented as powder and solvent for solution for
injection containing 5 mg
eptacog alfa (activated) per vial (corresponds to 250 KIU/vial).
NovoSeven RT 8 mg (400 KIU)
NovoSeven RT is presented as powder and solvent for solution for
injection containing 8 mg
eptacog alfa (activated) per vial (corresponds to 400 KIU/vial).
1 KIU equals 1,000 IU (International Units).
Eptacog alfa (activated) is recombinant coagulation factor VIIa
(rFVIIa) with a molecular
mass of approximately 50,000 Daltons produced in baby hamster kidney
cells (BHK Cells)
by recombinant DNA technology.
After
reconstitution,
the
product
contains
1
mg/ml
eptacog
alfa
(activated)
when
reconstituted with solvent.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White lyophilised powder. Solvent: clear colourless solution. The
reconstituted solution has a
pH of approximately 6.0. The reconstituted solution is colourless.
4 CLINICAL PARTICULARS
4.1 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.
4.2 Dose and method of administration
NOVOSEVEN
RT
must
be
reconstituted
with
the
sterile
solvent
provided
a