VICTOZA liraglutide (rys) 6mg/mL solution for injection, pre-filled pen

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Liraglutide, Quantity: 6 mg/mL

Tilgjengelig fra:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (International Name):

Liraglutide

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: phenol; hydrochloric acid; water for injections; propylene glycol; dibasic sodium phosphate dihydrate; sodium hydroxide

Administreringsrute:

Subcutaneous

Enheter i pakken:

1 x 3mL Pre-filled pen - Fill volume - 3mL with an overfill to ensure an extractable amount of at least 3mL, 3 x 3mL Pre-filled pen - Fill volume - 3mL with an overfill to ensure an extractable amount of at least 3mL, 2 x 3mL Pre-filled pen - Fill volume - 3mL with an overfill to ensure an extractable amount of at least 3mL, 10 x 3mL Pre-filled pen - Fill volume - 3mL with an overfill to ensure an extractable amount of at least 3mL, 5 x 3mL Pre-filled pen - Fill volume - 3mL with an overfill to ensure an extractable amount of at least 3mL

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Glycaemic control,Victoza is indicated as an adjunct to diet and exercise for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control:,- as monotherapy when metformin is contraindicated or is not tolerated,- in combination with other glucose lowering medicines.,Prevention of cardiovascular events,In patients where Victoza is indicated to improve glycaemic control, Victoza is indicated to reduce the risk of cardiovascular events in those at high cardiovascular risk, as an adjunct to standard of care therapy (see CLINICAL TRIALS).

Produkt oppsummering:

Visual Identification: Clear, colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

2010-08-26

Informasjon til brukeren

Victoza cmi-v10
Page 1 of 8
VICTOZA
®
_liraglutide (rys) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT IS IN THIS LEAFLET ................ 1
WHAT VICTOZA
® IS USED FOR ........ 1
BEFORE YOU USE VICTOZA
® ........... 1
HOW TO USE VICTOZA
® ................. 2
WHILE YOU ARE USING VICTOZA
® .. 3
THINGS TO BE CAREFUL OF .............. 3
SIDE EFFECTS ................................. 3
AFTER USING VICTOZA
® ................. 4
PRODUCT DESCRIPTION ................. 4
FURTHER INFORMATION ................. 4
INSTRUCTIONS FOR USE ................. 5
This leaflet answers some common
questions about Victoza
®
.
It does not contain all the available
information. It does not take the place
of talking to your doctor, diabetes
education nurse or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you
using
Victoza
®
against
the
benefits they expect it will have for
you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
USING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VICTOZA
® IS USED
FOR
Victoza
®
contains
the
active
ingredient liraglutide. This belongs
to a group of medicines called ‘GLP-
1 receptor agonists’. Victoza
®
is an
injection that is used once a day.
Victoza
®
is
used
to
treat
type
2
diabetes mellitus.
Diabetes mellitus is a condition where
your
pancreas
does
not
produce
enough insulin to control your blood
sugar (glucose) level.
If you have type 2 diabetes mellitus
your body is also not able to use
insulin properly.
Victoza
®
helps your body to produce
more insulin when your blood sugar
level is high.
Victoza
®
is used on its own if your
blood sugar is not properly controlled
by diet and exercise alone and you
cannot
use
metformin
(another
diabetes medicine). Victoza
®
is also
able to be used with other medicines
for
diabetes
when
they
are
not
enough to control your blood sugar
levels.
Victoza
®
is
used
in
addition
to
standard of care therapy to reduce the
risk of a heart disease related e

Preparatomtale

_Victoza pi 9 _
_ _
_Page 1 of 26_
AUSTRALIAN PRODUCT INFORMATION
VICTOZA
®
liraglutide solution for injection
1.
NAME OF THE MEDICINE
liraglutide (rys)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Victoza contains liraglutide, a human glucagon-like peptide-1 (GLP-1)
analogue that binds to and
activates the GLP-1 receptor (GLP-1R). Liraglutide is produced by
recombinant DNA technology using
_Saccharomyces cerevisiae_
.
Victoza is a solution for injection in a pre-filled pen. One mL of
solution contains 6 mg salt-free
anhydrous liraglutide. One pre-filled pen contains 18 mg liraglutide
in 3 mL
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Victoza is a solution for injection. It is a sterile, clear,
colourless or almost colourless, isotonic solution,
pH=8.15.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glycaemic control
Victoza is indicated as an adjunct to diet and exercise for treatment
of adults with type 2 diabetes
mellitus to achieve glycaemic control:
•
as monotherapy when metformin is contraindicated or is not tolerated
•
in combination with other glucose lowering medicines.
Prevention of cardiovascular events
In patients where Victoza is indicated to improve glycaemic control,
Victoza is indicated to reduce the
risk of cardiovascular events in those at high cardiovascular risk, as
an adjunct to standard of care
therapy (see section 5.1 Pharmacodynamic Properties-Clinical trials).
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage
To improve gastrointestinal tolerability, the starting dose is 0.6 mg
Victoza daily. After at least one
week, the dose should be increased to 1.2 mg. Based on clinical
response and tolerability, and after at
least one week, the dose can be increased to 1.8 mg to achieve maximum
efficacy. Daily doses higher
than 1.8 mg are not recommended.
Victoza may
be
used
when
previous
therapies provide
insufficient
glycaemic
control: in dual
combination
with
metformin
or
a
sulfonylurea;
or
in
triple
combination
with
metformin
and
sulfonylurea;