VICTOZA

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

LIRAGLUTIDE

Disponible des:

NOVO NORDISK LTD., ISRAEL

Codi ATC:

A10BX07

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

LIRAGLUTIDE 6.0 MG/ML

Vía de administración:

S.C

tipo de receta:

Required

Fabricat per:

NOVO NORDISK A/S, DENMARK

Grupo terapéutico:

LIRAGLUTIDE

Área terapéutica:

LIRAGLUTIDE

indicaciones terapéuticas:

Victoza is indicated for:• 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:1. As monotherapy when metformin is considered inappropriate due to intolerance or contraindications2. In addition to other medicinal products for the treatment of diabetes.• To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease

Data d'autorització:

2015-02-28

Informació per a l'usuari

Victoza IL PIL
OCT 23 - notification
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
VICTOZA
SOLUTION FOR INJECTION IN PRE-FILLED PEN
ACTIVE INGREDIENT: liraglutide 6 mg/ml
Inactive ingredients and allergens in the medicine: see section 2
"Important information
about some of this medicine’s ingredients
" and section 6 "Additional information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
Victoza is indicated for 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:
1.
As monotherapy when you cannot use metformin (another medicine for the
treatment of diabetes) due to intolerance or contraindication.
2.
Combined with other medicines for the treatment of diabetes when they
are not
sufficient to control your blood sugar levels, such as metformin,
pioglitazone,
sulfonylurea, SGLT2 inhibitors and/or insulin.
•
Victoza is administered for reduction of the risk of major
cardiovascular events in
adults with type 2 diabetes and cardiovascular diseases.
THERAPEUTIC GROUP: medicines for the treatment of diabetes, GLP-1
analogs.
Victoza contains the active substance liraglutide. It helps your body
reduce your blood sugar
level only when the blood sugar level is too high. It also slows food
passage through your
stomach and may help prevent heart disease.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive (allergic) to liraglutide or to any of the other
ingredients in this medicine
(see section 6 "Additional information").
SPECIAL W

Fitxa tècnica

Victoza IL SPC OCT 23 - notification
1.
NAME OF THE MEDICINAL PRODUCT
Victoza
®
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:

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:
1.
As monotherapy when metformin is considered inappropriate due to
intolerance or
contraindications
2.
In addition to other medicinal products for the treatment of diabetes.

To reduce the risk of major adverse cardiovascular events
(cardiovascular death, non-fatal
myocardial infarction, or non-fatal stroke) in adults with type 2
diabetes mellitus and established
cardiovascular disease
.
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-