Ozempic® 1.34 mgml (1 mgdose) Solution for injection in pre-filled pen

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

SEMAGLUTIDE

Dostupné z:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Medzinárodný Name):

SEMAGLUTIDE

Počet v balení:

1 Units

Výrobca:

Novo Nordisk A/S

Príbalový leták

OZEMPIC
®
SOLUTION FOR INJECTION
IN PRE-FILLED PEN
Semaglutide 1.34 mg/ml (0.25, 0.5 mg/dose, 1 mg/dose)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
WHAT IS IN THIS LEAFLET
1.
What Ozempic
®
is used for
2.
How Ozempic
®
works
3.
Before you use Ozempic
®
4.
How to use Ozempic
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Ozempic
®
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1.
WHAT OZEMPIC
®
IS USED FOR
Ozempic
®
is used to treat adults (aged
18
years
and
older)
with
type
2
diabetes when diet and exercise is not
enough:
►
on its own – when you cannot use
metformin
(another
diabetes
medicine) or
►
with other medicines for diabetes –
when they are not enough to control
your blood sugar levels. These may
be medicines you take by mouth or
inject such as insulin.
Prevention of cardiovascular events
Ozempic
®
is indicated to reduce the
risk of major adverse cardiovascular
events (MACE) such as heart attack,
stroke or death in adults with type 2
diabetes mellitus with known heart
disease or
at
high risk for
heart
disease.
It is important that you continue with
your diet and exercise plan as told by
your doctor, pharmacist or nurse.
2.
HOW OZEMPIC
®
WORKS
Ozempic
®
contains
the
active
substance semaglutide. It helps your
body reduce your blood sugar level
only when blood sugar is too high and
can help prevent heart disease.
3.
BEFORE YOU USE OZEMPIC
®
-
_WHEN YOU MUST NOT USE IT_
If you are allergic to semaglutide or
any of the other ingredients of this
medicine.
-
_BEFORE YOU START TO USE IT_
Talk
to
your
doctor,
pharmacist
or
nurse before using Ozempic
®
.
WARNINGS AND PRECAUTIONS
This
medicine
is
not
the
same
as
insulin and you should not use it if:
►
you
have
type
1
diabetes
– a
condition where your body does not
produce any insulin
►
you develop diabetic ketoacidosis
– a complication of diabetes with high
blood
sugar,
breathing
difficulty,
confusion, excessive thirst, a sweet
smell
to
the
breath
or
a
sweet
or

Súhrn charakteristických

1
Ozempic
®
Professional leaflet_EN-Jun-2023
Based on EU text: 20230124_EN_A0Z0000000A9001_OZE_13-3
1.
NAME OF THE MEDICINAL PRODUCT
OZEMPIC
®
1.34 mg/ml (0.25 mg, 0.5 mg/dose)
Solution for injection in pre-filled pen
OZEMPIC
®
1.34 mg/ml (1 mg/dose)
Solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Ozempic_
_®_
_1.34 mg/ml (0.25 mg, 0.5 mg/dose) Solution for injection in
pre-filled pen_
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled
pen contains 2 mg
semaglutide* in 1.5 ml solution.
_Ozempic_
_®_
_1.34 mg/ml (1 mg/dose) Solution for injection in pre-filled pen_
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled
pen contains 4 mg
semaglutide* in 3 ml solution. Each dose contains 1 mg of semaglutide
in 0.74 ml
solution.
*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 or almost colourless, isotonic solution; pH=7.4.
4.1
THERAPEUTIC INDICATIONS
Ozempic
®
is indicated for the treatment of adults 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.
Prevention of cardiovascular events:
Ozempic
®
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.
For trial results with respect to combinations, effects on glycaemic
control and
cardiovascular events, and the populations studied, see sections 4.4,
4.5 and 5.1
_._
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The starting dose is 0.25 mg semaglutide once w