SAXENDA

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

LIRAGLUTIDE

Disponibbli minn:

NOVO NORDISK LTD., ISRAEL

Kodiċi ATC:

A10BX07

Għamla farmaċewtika:

SOLUTION FOR INJECTION

Kompożizzjoni:

LIRAGLUTIDE 6 MG / 1 ML

Rotta amministrattiva:

S.C

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

NOVO NORDISK A/S, DENMARK

Żona terapewtika:

LIRAGLUTIDE

Indikazzjonijiet terapewtiċi:

AdultsSaxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of •≥30 kg/m² (obesity), or •≥27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension or dyslipidaemia, and who have failed a previous weight management intervention. Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight.Adolescents (≥12 years)Saxenda can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with:• obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points)* and• body weight above 60 kg. Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. Re-evaluation should be performed periodically

Data ta 'l-awtorizzazzjoni:

2021-02-28

Fuljett ta 'informazzjoni

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s prescription only
Saxenda
®
Solution for injection in pre-filled pen
Active ingredient: liraglutide 6 mg/ml
Inactive ingredients and allergens in the preparation: 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 the medicine. If you have any
further questions,
ask 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?
Saxenda is used for weight loss in addition to diet and exercise in
adults aged 18 and
above who have:
•
a BMI of 30 kg/m
2
or greater (obesity) or
•
a BMI of 27 to 30 kg/m
2
(overweight) and weight-related health problems (such
as diabetes, high blood pressure, abnormal levels of fats in the
blood) and who
have failed a previous weight management intervention.
BMI (Body Mass Index) is a measure of weight in relation to height.
You should only continue using Saxenda if you have lost at least 5% of
your initial
body weight after 12 weeks of treatment with the 3.0 mg/day dose (see
section 3).
Consult your doctor before you continue.
Saxenda can be used in addition to healthy diet and increased physical
activity for
weight management in adolescents aged 12 years and older with:
•
obesity (diagnosed by a doctor)
•
body weight above 60 kg
You should only continue using Saxenda if you have lost at least 4% of
your BMI
after 12 weeks on the 3.0 mg/day dose or maximum tolerated dose (see
section 3).
Consult your doctor before you
continue.
Therapeutic group: Drugs for treatment of diabetes, glucagon-like
peptide-1
(GLP-1) analogs.
_ _
Saxenda is a weight loss medicine that contains the active sub

Karatteristiċi tal-prodott

1
1.
NAME OF THE MEDICINAL PRODUCT
Saxenda
®
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
Adults
Saxenda is indicated as an adjunct to a reduced-calorie diet and
increased physical activity for weight
management in adult patients with an initial Body Mass Index (BMI) of
•
_≥ _
30 kg/m² (obesity), or
•
_≥ _
27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one
weight-related
comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes
mellitus), hypertension, or
dyslipidaemia and who have failed a previous weight management
intervention.
Treatment with Saxenda should be discontinued after 12 weeks on the
3.0 mg/day dose if patients
have not lost at least 5% of their initial body weight.
Adolescents (≥12 years)
Saxenda can be used as an adjunct to a healthy nutrition and increased
physical activity for weight
management in adolescent patients from the age of 12 years and above
with:
•
obesity (BMI corresponding to ≥30 kg/m
2
for adults by international cut-off points)* and
•
body weight above 60 kg.
Treatment with Saxenda should be discontinued and re-evaluated if
patients have not lost at least 4%
of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or
maximum tolerated dose. Re-
evaluation should be performed periodically.
*IOTF BMI cut-off points for obesity by sex between 12–18 years (see
table 1):
_ _
Table 1 IOTF BMI cut-off points for obesity by sex between 12–18
years
Age
(years)
BMI corresponding to 30 kg/m
2
for adults by
international cut-off points.
Males
Females
2
12
26.02
26.67
12.5
26.43
27.24
13
26.84
27.76
1