Ozempic 1mg0.74ml solution for injection 3ml pre-filled pen

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Semaglutide

Доступна с:

Novo Nordisk Ltd

код АТС:

A10BJ06

ИНН (Международная Имя):

Semaglutide

дозировка:

1.34mg/1ml

Фармацевтическая форма:

Solution for injection

Администрация маршрут:

Subcutaneous

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: ; GTIN: 5017954002245

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OZEMPIC® 1 MG
Solution for injection in pre-filled pen
SEMAGLUTIDE
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Ozempic® is and what it is used for
2.
What you need to know before you use Ozempic®
3.
How to use Ozempic®
4.
Possible side effects
5.
How to store Ozempic®
6.
Contents of the pack and other information
1.
WHAT OZEMPIC® IS AND WHAT IT IS USED FOR
Ozempic® contains the active substance semaglutide. It
_ _
helps your body reduce your blood sugar level
only when blood sugar is too high and can help prevent heart disease.
Ozempic® is used:
•
on its own – if your blood sugar is not controlled well enough by
diet and exercise alone, and
you cannot use metformin (another diabetes medicine) or
•
with other medicines for diabetes – when they are not enough to
control your blood sugar levels.
These other medicines may include: oral antidiabetics (such as
metformin, thiazolidinediones,
sulfonylureas, sodium-glucose cotransporter 2 (SGLT2) inhibitor) or
insulin.
It is important that you continue with your diet and exercise plan as
told by your doctor, pharmacist or
nurse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OZEMPIC®
_ _
DO NOT USE OZEMPIC®
•
if you are allergic to semaglutide or

Характеристики продукта

OZEMPIC 0.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
Summary of Product Characteristics Updated 04-Feb-2021 | Novo Nordisk
Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
1. NAME OF THE MEDICINAL PRODUCT
Ozempic 0.25 mg solution for injection in pre-filled pen
Ozempic 0.5 mg solution for injection in pre-filled pen
Ozempic 1 mg solution for injection in pre-filled pen
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ozempic 0.25 mg solution for injection
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled
pen contains 2 mg semaglutide* in 1.5 ml solution.
Each dose contains 0.25 mg of semaglutide in 0.19 ml solution.
Ozempic 0.5 mg solution for injection
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled
pen contains 2 mg semaglutide* in 1.5 ml solution.
Each dose contains 0.5 mg of semaglutide in 0.37 ml solution.
Ozempic 1 mg solution for injection
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled
pen contains 4 mg semaglutide* in 3.0 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. CLINICAL PARTICULARS
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.
For study results with respect to combinations, effects on glycaemic
control and cardi