Saxenda

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Liraglutide 6 mg/mL;  

Fáanlegur frá:

Novo Nordisk Pharmaceuticals Ltd

INN (Alþjóðlegt nafn):

Liraglutide 6 mg/mL

Skammtar:

6 mg/mL

Lyfjaform:

Solution for injection

Samsetning:

Active: Liraglutide 6 mg/mL   Excipient: Dibasic sodium phosphate dihydrate Hydrochloric acid Phenol Propylene glycol Sodium hydroxide Water for injection

Gerð lyfseðils:

Prescription

Framleitt af:

Novo Nordisk A/S

Ábendingar:

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 or greater (obese) or · 27 kg/m2 or greater (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.

Vörulýsing:

Package - Contents - Shelf Life: Cartridge, glass, 3 mL Pre-filled pen injector - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 1 months opened stored at or below 30°C protect from light. or In a refrigerator at 2° to 8°C, do not freeze. - Cartridge, glass, 3 mL Pre-filled pen injector - 3 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 1 months opened stored at or below 30°C protect from light. or In a refrigerator at 2° to 8°C, do not freeze. - Cartridge, glass, 3 mL Pre-filled pen injector - 5 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 1 months opened stored at or below 30°C protect from light. or In a refrigerator at 2° to 8°C, do not freeze.

Leyfisdagur:

2015-06-11

Upplýsingar fylgiseðill

Saxenda®
VV-LAB-098366
1
SAXENDA
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SAXENDA®?
Saxenda® contains the active ingredient liraglutide. Saxenda® is
used in weight loss, in addition to diet and exercise in adults
aged 18 years or older.
For more information, see Section 1. Why am I using Saxenda®? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SAXENDA®?
Do not use if you have ever had an allergic reaction to liraglutide or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Saxenda®? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Saxenda® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE SAXENDA®?
•
Your doctor or pharmacist will have given you advice on how to use
your medicine.
•
The usual starting dose of Saxenda® is 0.6 mg once per day, which
will be increased step wise until reaching the
recommended dose of 3.0 mg once a day.
More instructions can be found in Section 4. How do I use Saxenda®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SAXENDA®?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist or health professional you
visit that you are using Saxenda®.
•
Tell your doctor if you have diabetes, or a racing heartbeat when at
rest.
•
Do not use Saxenda® in combination with other medicines that contain
GLP-1 receptor agonists.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine unless your doctor tells you to.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how Saxenda®
affects you.
DRINKING
ALCOHOL
•
n/a
LOOKIN

Vara einkenni

_Saxenda ds-v11 _
_VV-LAB-098465_
_ _
_ _
_ _
_Page 1 of 26 _
NEW ZEALAND DATASHEET
1 PRODUCT NAME
SAXENDA
®
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 6 mg salt-free anhydrous liraglutide. One pre-filled pen
contains 18 mg
liraglutide in 3 ml.
3 PHARMACEUTICAL FORM
SAXENDA is a sterile, clear, colourless, isotonic solution of
liraglutide 6 mg/ml (pH=8.15).
SAXENDA is a solution for injection in a pre-filled pen.
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_. In liraglutide, the
lysine at position 34 has been
replaced with arginine, and a palmitic acid has been attached via a
glutamoyl spacer to lysine
at position 26.
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]_. _
_ _
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.
ADMINISTRATION
SAXENDA is for subcutaneous use only. It must NOT be administered
intravenously or
intramuscularly.
SAXENDA is administered once daily at any time, independent of meals.
It should be injected
in the abdomen, in the