SAXENDA® SOLUTION FOR INJECTION IN PRE-FILLED PEN 6MGML

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

Liraglutide

Հասանելի է:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

ATC կոդը:

A10BX07

Դեղագործական ձեւ:

INJECTION, SOLUTION

Կազմը:

Liraglutide 6.0 mg/ml

Կառավարման երթուղին:

SUBCUTANEOUS

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

Novo Nordisk A/S

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2017-10-09

Ապրանքի հատկությունները

1
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:

an inadequate response to reduced calorie diet and increased physical
activity alone, and
•
obesity (BMI corresponding to ≥30 kg/m
2
for adults by international cut-off points)* and
•
body weight above 60 kg.
Limitations of Use: The safety and effectiveness of Saxenda
®
in pediatric patients with type 2 diabetes have
not been established.
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.
*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