Apidra

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

Insulin glulisine

Verfügbar ab:

Sanofi-Aventis Australia Pty Ltd

Klasse:

Medicine Registered

Gebrauchsinformation

APIDRA
®

_(A-PID-RA)_
_insulin glulisine (in-sue-lin glue-lee-seen)_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Apidra.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or diabetes educator.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Apidra against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT APIDRA IS USED
FOR
Apidra is used to reduce high blood
sugar (glucose) levels in people with
diabetes mellitus.
Apidra is a modified insulin that is
very similar to human insulin. It is a
substitute for the insulin produced by
the pancreas.
Apidra is a short-acting insulin. Your
doctor may tell you to use a long-
acting insulin in combination with
Apidra.
Apidra is not addictive.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY APIDRA HAS
BEEN PRESCRIBED FOR YOU.
BEFORE YOU USE APIDRA
_WHEN YOU MUST NOT USE_
_APIDRA_
DO NOT USE APIDRA:
-
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing insulin
•
any of the ingredients contained
in Apidra listed at the end of this
leaflet
Some of the symptoms of an allergic
reaction may include:
•
redness, swelling, rash and
itching at the injection site
•
rash, itching or hives on the skin
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
-
IF YOU ARE EXPERIENCING LOW
BLOOD SUGAR LEVELS
(HYPOGLYCAEMIA - A "HYPO").
If you have a lot of hypos discuss
appropriate treatment with your
doctor.
-
AFTER THE EXPIRY DATE PRINTED ON
THE PACK OR IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF
TAMPERING.
If you use Apidra after the expiry
date has passed, it may not work as
well. If it has expired or is damaged,
return it to your pharmacist for
disposal.
-
IF THE PRODUCT APP

Fachinformation

 
Apidra PI MKT 
#74921v8.0 
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PRODUCT INFORMATION 
APIDRA 

NAME OF THE DRUG 
Insulin glulisine 
DESCRIPTION 
APIDRA  [insulin  glulisine  injection  {rDNA  origin}]  is  a  recombinant  human  insulin  analogue 
produced  by  recombinant  DNA  technology.  Insulin  glulisine  differs  from  human  insulin  in  that  the 
amino  acid  asparagine  at  position  B3  is  replaced  by  lysine  and  the  lysine  in  position  B29  is 
replaced  by  glutamic  acid.  The  chemical  name  is  3
B
-Lys-29
B
-Glu-human  insulin.  The  empirical 
formula  is  C
258
H
384
N
64
O
78
S
6
  ,  the molecular  weight  is  5823  and the  CAS number  is  207748-29-6. 
The structural formula is shown below: 

APIDRA is a sterile clear, colourless solution of insulin
glulisine in vials and cartridges for use as an 
injection. APIDRA contains 100 IU/mL (3.49 mg/mL) insulin glulisine. It also  contains meta-cresol, 
trometamol,  sodium  chloride,  polysorbate  20,  hydrochloric  acid  and  sodium  hydroxide  for 
adjustment to pH 7.3, and water for injections.   
PHARMACOLOGY 
MODE OF ACTION 
The  primary  activity  of  insulins  and  insulin  analogues,  including  insulin  glulisine,  is  regulation  of 
glucose metabolism. Insulins lower  blood glucose levels by stimulating peripheral glucose uptake 
by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis in 
the adipocyte, inhibit proteolysis and enhance protein
synthesis. 
PHARMACODYNAMICS 
The  glucose  lowering  activities  of  APIDRA  and  of  regular  human  insulin  are  equipotent  when 
administered by the intravenous route. 
Studies  in  healthy  volunteers  and  patients  with  diabetes  de