Victoza® solution for injection in pre-filled pen 6mgml

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Liraglutide

Tersedia dari:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Kode ATC:

A10BJ02

Dosis:

6mg/ml

Bentuk farmasi:

INJECTION, SOLUTION

Komposisi:

Liraglutide 6mg/ml

Rute administrasi :

SUBCUTANEOUS

Jenis Resep:

Prescription Only

Diproduksi oleh:

Novo Nordisk A/S

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

2010-12-30

Selebaran informasi

Page 1 of 16 

NAME OF THE MEDICINAL PRODUCT 

VICTOZA
® 
6 mg/ml  
Solution for injection in pre-filled pen 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
One ml of solution contains 6 mg of liraglutide*.  
One pre-filled pen contains 18 mg liraglutide in 3 ml. 
*human glucagon-like peptide-1 (GLP-1) analogue produced by
recombinant DNA 
technology in _Saccharomyces cerevisiae_. 
For a full list of excipients, see pharmaceutical  particulars. 

PHARMACEUTICAL FORM 
Solution for injection in pre-filled pen (injection).  
Clear, colourless, isotonic solution; pH=8.15. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Victoza
®
 is indicated as an adjunct to diet and exercise for treatment of
adults 
with type 2 diabetes mellitus to achieve glycaemic control: 
In combination with: 
– Metformin or a sulphonylurea, in patients with insufficient
glycaemic control 
despite maximal tolerated dose of monotherapy with metformin or
sulphonylurea. 
In combination with: 
– Metformin and a sulphonylurea
in patients with insufficient glycaemic control 
despite dual therapy. 
In combination with: 
-Metformin and a basal insulin in patients not achieving
adequate glycaemic 
control with Victoza
®
 and metformin. 

POSOLOGY AND METHOD OF ADMINISTRATION 
_POSOLOGY _
To improve gastro-intestinal tolerability, the starting dose is 0.6
mg liraglutide 
daily. After at least one week, the dose should be increased
to 1.2 mg. Some 
patients are expected to benefit from an increase in dose from 1.2 mg to 1.8 mg 
and based on clinical response, after at least one week the dose can
be increased 
to 1.8 mg to further improve glycaemic control. Daily doses higher
than 1.8 mg 
are not recommended. 
Victoza
®
 can be added to existing metformin or to a combination
of metformin 
and thiazolidinedione therapy. The current dose of metformin and 
thiazolidinedione can be continued unchanged. 
Victoza
®
 can be a

Karakteristik produk

Page 1 of 21
NAME OF THE MEDICINAL PRODUCT
VICTOZA
®
6 mg/ml
Solution for injection in pre-filled pen
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 6 mg of liraglutide*.
One pre-filled pen contains 18 mg liraglutide in 3 ml.
*
human
gl
ucagon-like
peptide-1
(GLP-1)
analogue
produced
by
recombinant
DNA
technology
in
_Saccharomyces cerevisiae_
.
For the full list of excipients, see
_Pharmaceutical part_
_iculars_
.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless or almost colourless, isotonic solution; pH=8.15.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Victoza
®
is indicated for the treatment of adults, adolescents and children
aged 10 years and
above with insufficiently controlled type 2 diabetes mellitus as an
adjunct to diet and exercise
•
as monotherapy when metformin is considered inappropriate due to
intolerance or
contraindications
•
in
addition
to
other
medicinal
products
for
the
treatment
of
diabetes
(see
_Pharmacodynamic properties – Clinical efficacy and safety
section)._
Prevention of cardiovascular events
Victoza is indicated as an adjunct to diet, exercise and standard care
therapy to reduce the risk
of major cardiovascular events (cardiovascular death, non-fatal
myocardial infarction, or
nonfatal stroke) in adult patients with type 2 diabetes mellitus and
established cardiovascular
disease who have inadequate glycaemic control (see
_Pharmacodynamic properties – Clinical _
_efficacy and safety section_
).
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
To improve gastro-intestinal tolerability, the starting dose is 0.6 mg
liraglutide daily. After at
least one week, the dose should be increased to 1.2 mg. Some patients
are expected to benefit
from an increase in dose from 1.2 mg to 1.8 mg and based on clinical
response, after at least
one week, the dose can be increased to 1.8 mg to further improve
glycaemic control. Daily
doses higher than 1.8 mg are not recommended.
When Victoza
®
is added to a sulfonylurea or insulin, a reduction in the dose