Eperzan 50mg powder and solvent for solution for injection pre-filled pen

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Albiglutide

Доступна з:

GlaxoSmithKline UK Ltd

Код атс:

A10BJ04

ІПН (Міжнародна Ім'я):

Albiglutide

Дозування:

50mg

Фармацевтична форма:

Powder and solvent for solution for injection

Адміністрація маршрут:

Subcutaneous

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 06010203; GTIN: 5000123114337

інформаційний буклет

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPERZAN 50 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Albiglutide
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 TAKING 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 or pharmacist.
-
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, nurse or pharmacist.
This includes any possible side
effects not listed in this leaflet.See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT EPERZAN IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPERZAN
3.
HOW TO TAKE EPERZAN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE EPERZAN
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
INSTRUCTIONS FOR USE OF THE PRE-FILLED PEN
_(overleaf)_
QUESTIONS AND ANSWERS ABOUT THE INSTRUCTIONS FOR USE OF THE PRE-FILLED
PEN
_ _
READ BOTH SIDES OF THIS LEAFLET
1.
WHAT EPERZAN IS AND WHAT IT IS USED FOR
Eperzan contains the active ingredient albiglutide which belongs to a
group of medicines called GLP-1
receptor agonists that are used to lower blood sugar (glucose) in
adults with Type 2 diabetes.
You have Type 2 diabetes either:

because your body does not make enough insulin to control the level of
sugar in your blood
or

because your body is not able to use the insulin properly.
Eperzan helps your body to increase the production of insulin when
your blood sugar is high.
Eperzan is used to help control your blood sugar, either:
-
on its own if your blood sugar is not properly controlled by diet and
exercise alone, and you can’t take
metformin (another diabetes medicine)
or
-
in combinati

Характеристики продукта

OBJECT 1
EPERZAN 30 MG POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION
Summary of Product Characteristics Updated 19-Sep-2017 |
GlaxoSmithKline UK
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
Eperzan 30 mg powder and solvent for solution for injection
Eperzan 50 mg powder and solvent for solution for injection
2. Qualitative and quantitative composition
Eperzan 30 mg powder and solvent for solution for injection
Each pen delivers 30 mg albiglutide per 0.5 ml dose following
reconstitution.
Eperzan 50 mg powder and solvent for solution for injection
Each pen delivers 50 mg albiglutide per 0.5 ml dose following
reconstitution.
Albiglutide is a recombinant fusion protein consisting of two copies
of a 30-amino acid sequence of
modified human glucagon-like peptide 1 genetically fused in series to
human albumin.
Albiglutide is produced in _Saccharomyces cerevisiae_ cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for solution for injection.
Powder: lyophilised white to yellow powder.
Solvent: A clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Eperzan is indicated for the treatment of type 2 diabetes mellitus in
adults to improve glycaemic control
as:
Monotherapy
When diet and exercise alone do not provide adequate glycaemic control
in patients for whom use of
metformin is considered inappropriate due to contraindications or
intolerance.
Add-on combination therapy
In combination with other glucose-lowering medicinal products
including basal insulin, when these,
together with diet and exercise, do not provide adequate glycaemic
control (see section 4.4 and 5.1 for
available data on different combinations).
4.2 Posology and method of administration
Posology
The recommended dose