Saxenda
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
12-09-2023
Charakterystyka produktu
(SPC)
12-09-2023
Sprawozdanie z oceny publicznego
(PAR)
05-10-2023
Składnik aktywny:
liraglutide
Dostępny od:
Novo Nordisk A/S
Kod ATC:
A10BJ02
INN (International Nazwa):
liraglutide
Grupa terapeutyczna:
Drugs used in diabetes
Dziedzina terapeutyczna:
Obesity; Overweight
Wskazania:
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 (obese), 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, dyslipidaemia or obstructive sleep apnoea.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.
Podsumowanie produktu:
Revision: 14
Status autoryzacji:
Authorised
Data autoryzacji:
2015-03-23
Ulotka dla pacjenta
30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SAXENDA 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 Saxenda is and what it is used for
2.
What you need to know before you use Saxenda
3.
How to use Saxenda
4.
Possible side effects
5.
How to store Saxenda
6.
Contents of the pack and other information
1.
WHAT SAXENDA
IS AND WHAT IT IS USED FOR
WHAT SAXENDA IS
Saxenda is a weight loss medicine that contains the active substance
liraglutide. It is similar to a
natural occurring hormone called glucagon-like peptide-1 (GLP-1) that
is released from the intestine
after a meal. Saxenda works by acting on receptors in the brain that
control your appetite, causing you
to feel fuller and less hungry. This may help you eat less food and
reduce your body weight.
WHAT SAXENDA IS USED 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/m² or greater (obesity) or
•
a BMI of 27 kg/m² and less than 30 kg/m² (overweight) and
weight-related health problems
(such as diabetes, high blood pressure, abnormal levels of fats in the
blood or breathing
problems during sleep called ‘obstructive sleep apnoea’).
BMI (Body Mass Index) is a measure of your weight in relation to your
height.
You should only continue using Saxenda if you have lost at least 5% of
your initial body weight after
12 weeks on the 3.0 mg/day dose (see section 3). Cons
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Saxenda 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
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 (prediabetes or type 2 diabetes mellitus),
hypertension, dyslipidaemia or
obstructive sleep apnoea.
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.
3
*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
12
26.02
26.67
12.5
26.43
27.24
13
26.84
27.76
13.
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