Wegovy® 1.7 mg0.75 mL (1.7 mgdose) Solution for injection in pre-filled pen

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

SEMAGLUTIDE

Sẵn có từ:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Tên quốc tế):

SEMAGLUTIDE

Các đơn vị trong gói:

4 Pre-Filled Syringes

Sản xuất bởi:

Novo Nordisk Pharmaceutical Industries, LP

Tờ rơi thông tin

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WEGOVY
® SOLUTION FOR INJECTION IN PRE-FILLED PEN
Semaglutide (0.25 mg/0.5 mL (0.25mg/does), 0.5 mg/0.5 mL (0.5mg/does),
1 mg/0.5 mL (1mg/does), 1.7 mg/0.75 mL
(1.7mg/dose), 2.4 mg/0.75 mL (2.4mg/does))
1
WHAT IS IN THIS LEAFLET
1.
What Wegovy
®
is used for
2.
How Wegovy
®
works
3.
Before you use Wegovy
®
4.
How to use Wegovy
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Wegovy
®
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1. WHAT WEGOVY
® IS USED FOR
Wegovy
®
is used together with diet
and physical activity for weight loss
and to help keep the weight under
control. It is used in adults, who
have
•
a BMI of 30 kg/m² or greater
(obesity) or
•
a BMI of at least 27 kg/m² but
less than 30 kg/m² (overweight)
who have weight-related health
problems
(such
as
diabetes,
high blood pressure, abnormal
levels
of
fats
in
the
blood,
breathing
problems
during
sleep called ‘obstructive sleep
apnoea’ or a history of heart
attack, stroke or blood vessel
problems).
BMI
(Body
Mass
Index)
is
a
measure of your weight in relation
to your height.
2. HOW WEGOVY
® WORKS
Wegovy
®
is a medicine for weight
loss and weight maintenance that
contains
the
active
substance
semaglutide. It is similar to a natural
hormone
called
glucagon-like
peptide-1 (GLP-1) that is released
from the intestine after a meal. It
works
by
acting
on
targets
(receptors) in the brain that control
your appetite, causing you to feel
fuller
and
less
hungry
and
experience
less
craving
for
food.
This will help you eat less food and
reduce your body weight.
3. BEFORE YOU USE WEGOVY
®
_- WHEN YU MUST NOT USE IT _
DO NOT USE WEGOVY
®
•
if
you
are
allergic
to
semaglutide or any of the other
ingredients
of
this
medicine
(listed in section 8).
_- BEFORE YOU START TO USE IT _
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or
nurse before using Wegovy
®
.
The
use
of
Wegovy
®
is
not
recommended if you:
•
use other

Đặc tính sản phẩm

Wegovy
®
Professional leaflet EN-Jan-2022_8-9570-00-001-1
Based on EU text: 20211111_EN_06614_WEG_0-7
1
Wegovy
®
0.25 mg/0.5 mL (0.25 mg/dose) Solution for injection in pre-filled pen
Wegovy
®
0.5 mg/0.5 mL (0.5 mg/dose) Solution for injection in pre-filled pen
Wegovy
®
1 mg/0.5 mL (1 mg/dose) Solution for injection in pre-filled pen
Wegovy
®
1.7 mg/0.75 mL (1.7 mg/dose) Solution for injection in pre-filled pen
Wegovy
®
2.4 mg/0.75 mL (2.4 mg/dose) Solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Wegovy
®
0.25 mg solution for injection
Each single-use pre-filled pen contains 0.25 mg semaglutide* in 0.5 mL
solution. One mL of solution
contains 0.5 mg of semaglutide*.
Wegovy
®
0.5 mg solution for injection
Each single-use pre-filled pen contains 0.5 mg semaglutide* in 0.5 mL
solution. One mL of solution
contains 1 mg of semaglutide*.
Wegovy
®
1 mg solution for injection
Each single-use pre-filled pen contains 1 mg semaglutide* in 0.5 mL
solution. One mL of solution
contains 2 mg of semaglutide*.
Wegovy
®
1.7 mg solution for injection
Each single-use pre-filled pen contains 1.7 mg semaglutide* in 0.75 mL
solution. One mL of solution
contains 2.27 mg of semaglutide*.
Wegovy
®
2.4 mg solution for injection
Each single-use pre-filled pen contains 2.4 mg semaglutide* in 0.75 mL
solution. One mL of solution
contains 3.2 mg of semaglutide*.
*human glucagon-like peptide-1 (GLP-1) analogue produced in
_Saccharomyces cerevisiae _
cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
Clear and colourless isotonic solution; pH=7.4.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Wegovy
®
is indicated as an adjunct to a reduced-calorie diet and increased
physical activity for weight
management, including weight loss and weight maintenance, in adults
with an initial Body Mass Index
(BMI) of
Wegovy
®
Professional leaflet EN-Jan-2022_8-9570-00-001-1
Based on EU text: 20211111_EN_06614_WEG_