SAXENDA liraglutide (rys) 6mg/mL solution for injection, pre-filled pen

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

Liraglutide, Quantity: 6 mg/mL

Доступно од:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (Међународно име):

Liraglutide

Фармацеутски облик:

Injection, solution

Састав:

Excipient Ingredients: phenol; hydrochloric acid; water for injections; propylene glycol; dibasic sodium phosphate dihydrate; sodium hydroxide

Пут администрације:

Subcutaneous

Јединице у пакету:

5 x 3mL Pre-filled pen - Fill volume - 3mL with an overfill to ensure an extractable amount of at least 3mL, 3 x 3mL Pre-filled pen - Fill volume - 3mL with an overfill to ensure an extractable amount of at least 3mL, 1 x 3mL Pre-filled pen - Fill volume - 3mL with an overfill to ensure an extractable amount of at least 3mL

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

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:,- greater than or equal to 30 kg/m2 (obese) or,- greater than or equal to 27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and 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 a patient has not lost at least 5% of their initial body weight.

Резиме производа:

Visual Identification: Clear, colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Статус ауторизације:

Licence status A

Датум одобрења:

2015-12-24

Информативни летак

Saxenda
®
Page 1 of 11
Saxenda cmi-v5
SAXENDA
®
_Liraglutide (rys) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT SAXENDA
® IS AND WHAT IT IS
USED FOR ...................................... 1
BEFORE YOU USE SAXENDA
® .......... 1
HOW TO USE SAXENDA
® ................ 2
WHILE YOU ARE USING SAXENDA
® . 3
THINGS TO BE CAREFUL OF .............. 3
SIDE EFFECTS ................................. 3
AFTER USING SAXENDA
® ............... 4
PRODUCT DESCRIPTION .................. 4
FURTHER INFORMATION ................. 5
This leaflet answers some common
questions about Saxenda
®
. It does not
contain all the available information.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have risks and benefits.
You should discuss with your doctor
the risks of using Saxenda
®
against
the expected benefits.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
USING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SAXENDA
® IS AND
WHAT IT IS USED FOR
Saxenda
®
is a weight loss medicine
that
contains
the
active
ingredient
liraglutide. It is similar to a naturally
occurring hormone called GLP-1 that
is released from the intestine after a
meal. Saxenda
®
is an injection that is
used once a day.
Saxenda
®
is used for weight loss, in
addition to diet and exercise, in adults
aged 18 years and above who have:
•
a BMI greater than or equal to
30 (obese), or
•
a BMI greater than or equal to
27 and less than 30 (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’).
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.
Consult
your
doctor
before
you
continue.
Saxenda
®
should
be
used
with
a
reduced
calorie
diet
and
increased
physical activity.
BMI (Body Mass Index) is a simple
measure of your weight in

Карактеристике производа

_Saxenda pi-v5 _
_ _
_Page 1 of 26 _
AUSTRALIAN PRODUCT INFORMATION
SAXENDA
®
liraglutide solution for injection
1.
NAME OF THE MEDICINE
liraglutide (rys)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SAXENDA contains liraglutide, a human glucagon-like peptide-1 (GLP-1)
analogue that binds
to and activates the GLP-1 receptor (GLP-1R). Liraglutide is produced
by recombinant DNA
technology using
_Saccharomyces cerevisiae_
.
SAXENDA is a solution for injection in a pre-filled pen. One mL
contains 6 mg salt-free
anhydrous liraglutide. One pre-filled pen contains 18 mg liraglutide
in 3 mL.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
SAXENDA is a solution for injection. It is a sterile, clear,
colourless, isotonic solution,
pH=8.15.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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/m
2
(obese) or
•
≥27 kg/m
2
to <30 kg/m
2
(overweight) in the presence of at least one weight related
comorbidity,
such
as
dysglycaemia
(pre-diabetes
and
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 a
patient has not lost at least 5% of their initial body weight.
4.2
DOSE AND METHOD OF ADMINISTRATION
SAXENDA has not been studied in patients taking insulin. SAXENDA and
insulin should not
be used together [see section 4.4 Special Warnings and Precautions for
Use].
SAXENDA and VICTOZA both contain the same active ingredient,
liraglutide, and therefore
should not be used together. SAXENDA should not be used in combination
with any other
GLP-1 receptor agonist.
Dosage
The starting dose is 0.6 mg once daily. The dose should be increased
to 3.0 mg daily in
increments of 0.6 mg with at least one week intervals to improve
gastro-intestinal tolerability
(see Table 1). If escalation to the ne