Victoza

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

liraglutide

זמין מ:

Novo Nordisk A/S

קוד ATC:

A10BJ02

INN (שם בינלאומי):

liraglutide

קבוצה תרפויטית:

Drugs used in diabetes

איזור תרפויטי:

Diabetes Mellitus, Type 2

סממני תרפויטית:

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 exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin 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.

leaflet_short:

Revision: 23

מצב אישור:

Authorised

תאריך אישור:

2009-06-30

עלון מידע

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
VICTOZA 6 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
liraglutide
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 Victoza is and what it is used for
2.
What you need to know before you use Victoza
3.
How to use Victoza
4.
Possible side effects
5.
How to store Victoza
6.
Contents of the pack and other information
1.
WHAT VICTOZA IS AND WHAT IT IS USED FOR
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.
Victoza is used on its own if your blood sugar is not properly
controlled by diet and exercise alone,
and you cannot use metformin (another diabetes medicine).
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.
WHAT YOU NEED TO KNOW BEFORE YOU USE VICTOZA
DO NOT USE VICTOZA
–
if you are allergic to liraglutide 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 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 insuli

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Victoza 6 mg/ml
solution for injection in pre-filled pen
2.
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 section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless or almost colourless, isotonic solution; pH=8.15.
4.
CLINICAL PARTICULARS
4.1
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.
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.
4.2
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 (see section
4.4). Combination therapy with
sulfonylurea is only valid for adult patients.
Self-monitoring of blood glucose is not needed in order to adjust the
dose of Victoza. Blood glucose
self-monitoring is necessary to adjust the dose of sulfonylurea and