OZEMPIC 1MGDOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34MGML

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

Semaglutide

Verfügbar ab:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

ATC-Code:

A10BJ06

Darreichungsform:

INJECTION, SOLUTION

Zusammensetzung:

Semaglutide 1.34mg/ml

Verabreichungsweg:

SUBCUTANEOUS

Verschreibungstyp:

Prescription Only

Hergestellt von:

Novo Nordisk A/S( Bagsvaerd) (formulation and filling)

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

2021-04-21

Fachinformation

1
1.
Name of the medicinal product
Ozempic
®
1 mg/dose
Solution for injection in pre-filled pen
2.
Qualitative and quantitative composition
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled
pen contains 4 mg semaglutide*
in 3 ml solution. Each dose contains 1 mg of semaglutide in 0.74 ml
solution.
*Human glucagon-like peptide-1 (GLP-1) analogue produced in
Saccharomyces cerevisiae cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
Pharmaceutical form
Solution for injection (injection).
Clear and colourless or almost colourless, isotonic solution; pH=7.4.
4.1 Therapeutic indications
Ozempic
®
is indicated for the treatment of adults with insufficiently
controlled type 2 diabetes mellitus
as an adjunct to diet and exercise
•
as
monotherapy
when
metformin
is
considered
inappropriate
due
to
intolerance
or
contraindications
•
in addition to other medicinal products for the treatment of diabetes.
To reduce the risk of major adverse cardiovascular events in adults
with type 2 diabetes mellitus and
established cardiovascular disease (see section 5.1).
4.2
Posology and method of administration
Posology
The starting dose is 0.25 mg semaglutide once weekly. After 4 weeks
the dose should be increased to
0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once
weekly, the dose can be increased
to 1 mg once weekly to further improve glycaemic control.
Semaglutide 0.25 mg is not a maintenance dose. Weekly doses higher
than 1 mg are not recommended.
When Ozempic
®
is added to existing metformin and/or thiazolidinedione therapy or to
a sodium-glucose
cotransporter 2 (SGLT2) inhibitor, the current dose of metformin
and/or thiazolidinedione or SGLT2
inhibitor can be continued unchanged.
When Ozempic
®
is added to existing therapy of sulfonylurea or insulin, a reduction
in the dose of
sulfonylurea or insulin should be considered to reduce the risk of
hypoglycaemia (see sections 4.4 and
4.8).
Self-monitoring of blood glucose is not needed in order to adjust