VICTOZA 6MGML SOLUTION FOR INJECTION IN PRE-FILLED PEN

Country: Малезија

Језик: Енглески

Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активни састојак:

LIRAGLUTIDE

Доступно од:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Међународно име):

LIRAGLUTIDE

Јединице у пакету:

3ml mL

Произведен од:

NOVO NORDISK A/S

Информативни летак

VICTOZA
®
_Consumer Medication Information Leaflet (RiMUP) _
Liraglutide (6 mg/ml)
________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. What Victoza
®
is used for
2. How Victoza
®
works
3. Before you use Victoza
®
4. How to use Victoza
®
5. While you are using it
6. Side effects
7. Storage and Disposal of
Victoza
®
8. Product Description
9. Manufacturer
10. Product Registration Holder
11. Date of revision
1. WHAT VICTOZA
® IS USED FOR
Victoza
®
is
used
with
other
medicines for diabetes when they are
not
enough
to
control
your
blood
sugar levels. These may include:
-
oral
antidiabetics
(such
as
metformin,
pioglitazone,
sulfonylurea,
sodium-glucose
cotransporter 2
inhibitor
(SGLT2i)
and/or insulin.
2. HOW VICTOZA
® WORKS
Victoza

contains
the
active
substance liraglutide. It helps your
body reduce your blood sugar level
only when blood sugar is too high. It
also
slows
food
passage
through
your stomach and can help prevent
heart disease.
3. BEFORE YOU USE VICTOZA
®
_- WHEN YOU MUST NOT USE IT _
If you are allergic to liraglutide or
any of the other ingredients of this
medicine (listed in section 8, Product
Description).
CHILDREN AND ADOLESCENTS
Victoza
®
can be used in adolescents
and
children
aged
10
years
and
above.
No
data
are
available
in
children below 10 years of age.
_- BEFORE YOU START TO USE IT _
Talk to your doctor, pharmacist or
nurse:
- Before using Victoza
®
.
- If you have or have had a disease
of the pancreas.
This medicine should not be used if
you have type 1 diabetes (your body
does
not
produce
any
insulin)
or
diabetic ketoacidosis (a complication
of diabetes with high blood sugar
and increase in effort to breathe). It
is not an insulin and should therefore
not
be
used
as
a
substitute
for
insulin.
The
use
of
Victoza
®
is
not
recommended if you are on dialysis.
The
use
of
Victoza
®
is
not
recommended
if
you
have
severe
liver disease.
The
use
of
Victoza
®
is
not
recommended
if
you
have
severe
heart failure.
Thi

Карактеристике производа

Victoza
®
_Professional leaflet_STF-Oct-2020
1
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 glucagon-like peptide-1 (GLP-1) analogue produced by
recombinant DNA technology in
_Saccharomyces cerevisiae._
For the full list of excipients, see
_Pharmaceutical particulars._
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 type 2 diabetes mellitus to achieve glycaemic control in
combination with oral glucose-lowering
medicinal products and/or insulin when these, together with diet and
exercise, do not provide
adequate glycaemic control (see sections
_Special warnings and precautions for use_
and
_Pharmacodynamic properties _
for available data on the different combinations).
Prevention of cardiovascular events:
Victoza
®
is indicated to reduce the risk of major adverse cardiovascular events
(MACE), composed of
cardiovascular (CV) death, non-fatal myocardial infarction and
non-fatal stroke, in adults with type 2
diabetes who have established CV disease or are at high risk for CV
disease.
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.
When Victoza
®
is added to a sulfonylurea or insulin, a reduction in the dose of
sulfonylurea or insulin
should be considered to reduce the risk of hypoglycaemia (s