Ozempic

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

semaglutide

Saatavilla:

Novo Nordisk A/S

ATC-koodi:

A10BJ06

INN (Kansainvälinen yleisnimi):

semaglutide

Terapeuttinen ryhmä:

Drugs used in diabetes

Terapeuttinen alue:

Diabetes Mellitus

Käyttöaiheet:

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.For study 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.

Tuoteyhteenveto:

Revision: 10

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-02-08

Pakkausseloste

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OZEMPIC 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
semaglutide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor, pharmacist or
nurse.
–
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
–
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ozempic is and what it is used for
2.
What you need to know before you use Ozempic
3.
How to use Ozempic
4.
Possible side effects
5.
How to store Ozempic
6.
Contents of the pack and other information
1.
WHAT OZEMPIC IS AND WHAT IT IS USED FOR
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.
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.
It is important that you continue with your diet and exercise plan as
told by your doctor, pharmacist or
nurse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OZEMPIC
_ _
DO NOT USE OZEMPIC
•
if you are allergic to semaglutide or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using this medicine.
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 no

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ozempic 0.25 mg solution for injection in pre-filled pen
Ozempic 0.5 mg solution for injection in pre-filled pen
Ozempic 1 mg solution for injection in pre-filled pen
Ozempic 2 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ozempic 0.25 mg
solution for injection
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled
pen contains 2 mg semaglutide*
in 1.5 ml solution. Each dose contains 0.25 mg of semaglutide in 0.19
ml solution.
Ozempic 0.5 mg solution for injection
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled
pen contains 2 mg semaglutide*
in 1.5 ml solution. Each dose contains 0.5 mg of semaglutide in 0.37
ml solution.
Ozempic 1 mg solution for injection
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.
Ozempic 2 mg solution for injection
One ml of solution contains 2.68 mg of semaglutide*. One pre-filled
pen contains 8 mg semaglutide*
in 3 ml solution. Each dose contains 2 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.
CLINICAL PARTICULARS
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.
3
For trial results with respect to combinations, effects on glycaemic
control and cardiovascular events,
and the populations studied, see sections 4.4,