APIDRA SOLOSTAR 100 UNITSML SOLUTION FOR INJECTION IN A PRE-FILLED PEN

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

Insulin glulisine

Disponible desde:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

Designación común internacional (DCI):

Insulin glulisine

Unidades en paquete:

5Units Units

Fabricado por:

Sanofi-Aventis Deutschland GmbH

Información para el usuario

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
APIDRA SOLOSTAR 100 UNITS/ML
Solution for Injection in a Pre-filled Pen
Insulin glulisine (100 Units/ml)
1
WHAT IS IN THIS LEAFLET:
1. What is Apidra used for
2. How Apidra works
3. Before you use Apidra
4. How to use Apidra
5. While you are using Apidra
6. Side effects
7. Storage and disposal of Apidra
8. Product description
9.
Manufacturer and Product
Registration Holder
10. Date of revision WHAT IS APIDRA USED FOR
Apidra is used in the treatment of
adults,
adolescents
and
children
6
years or older with diabetes mellitus,
where
treatment
with
insulin
is
required. HOW APIDRA WORKS
Apidra is an antidiabetic agent, used
to reduce high blood sugar in patients
with
diabetes
mellitus.
Diabetes
mellitus is a disease where your body
does not produce enough insulin to
control the level of blood sugar.
It is made by biotechnology. It has a
rapid onset within 10-20 minutes and
a short duration, about 4 hours.
Insulin
glulisine
lowers
blood
glucose
levels
by
stimulating
peripheral glucose uptake, especially
by skeletal muscle and fat, and by
inhibiting
hepatic
glucose
production. Insulin inhibits lipolysis
(breakdown of fats) in the adipocyte
(cells for the storage of fat), inhibits
proteolysis (breakdown of proteins)
and enhances protein synthesis. BEFORE YOU USE APIDRA
_-When you must not use it _
- If you are allergic (hypersensitive)
to insulin glulisine or any of the other
ingredients of Apidra.
-
If
your
blood
sugar
is
too
low
(hypoglycaemia),
follow
the
guidance
for
hypoglycaemia
(see
HYPERGLYCAEMIA
AND
HYPOGLYCAEMIA at the end of
this leaflet).
_-Before you start to use it _
Apidra
in
a
pre-filled
pen
is
only
suitable for injecting just under the
skin.
Speak
to
your
doctor
if
you
need to inject your insulin by another
method.
Take special care with Apidra
Follow
closely
the
instructions
for
dose, monitoring (blood tests), diet
and physical activity (physical work
and exercise) as discussed with your
doctor.
Special patient groups
If you have liver or kidney problem

Ficha técnica

MY/API/1120/CCDSv12
PROPOSED CLEAN PACKAGE INSERT
SANOFI LOGO
1. NAME OF THE MEDICINAL PRODUCT
Apidra SoloStar 100 Units/ml solution for injection in a pre-filled
pen
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Each pen contains 3 ml of solution for injection, equivalent to 300
Units.
Insulin glulisine is produced by recombinant DNA technology in
_Escherichia coli_.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection in a pre-filled pen.
Clear, colourless, aqueous solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of adults, adolescents and children 6 years or older with
diabetes mellitus, where
treatment with insulin is required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The potency of this preparation is stated in units. These units are
exclusive to Apidra and are not
the same as IU or the units used to express the potency of other
insulin analogues (see section
5.1).
Apidra should be used in regimens that include an intermediate or long
acting insulin or basal
insulin analogue and can be used with oral hypoglycaemic agents.
The dosage of Apidra should be individually adjusted.
Special populations
_Renal impairment _
The pharmacokinetic properties of insulin glulisine are generally
maintained in patients with renal
impairment. However, insulin requirements may be reduced in the
presence of renal impairment
(see section 5.2).
_ _
_Hepatic impairment _
The pharmacokinetic properties of insulin glulisine have not been
investigated in patients with
decreased liver function. In patients with hepatic impairment, insulin
requirements may be
diminished due to reduced capacity for gluconeogenesis and reduced
insulin metabolism.
_ _
_Elderly _
Limited pharmacokinetic data are available in elderly patients with
diabetes mellitus. Deterioration
of renal function may lead to a decrease in insulin requirements.
_ _
_Paediatric population _
There is insufficient clinical information o