APIDRA insulin glulisine (rbe) 100IU/mL 3mL injection cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Insulin glulisine, Quantity: 3.49 mg/mL

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: trometamol; sodium chloride; polysorbate 20; hydrochloric acid; sodium hydroxide; water for injections; metacresol

Administration route:

Subcutaneous

Units in package:

5 x 3mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Apidra is indicated for the treatment of type 1 and type 2 diabetes mellitus in adults and children of 4 years or above who require insulin for the control of hyperglycaemia.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2005-05-02

Patient Information leaflet

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 APPEARS CLOUDY,
DIS

Summary of Product characteristics

apidra-ccdsv12-piv13-15feb21
Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION – APIDRA (INSULIN
GLULISINE)
1
NAME OF THE MEDICINE
Insulin glulisine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Apidra contains 100 IU/mL (3.49 mg/mL) insulin glulisine.
For full list of excipients, see Section 6.1, List of Excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
Apidra is a sterile clear, colourless solution of insulin glulisine in
vials and cartridges for use
as an injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Apidra is indicated for the treatment of type 1 and type 2 diabetes
mellitus in adults and
children of 4 years or above who require insulin for the control of
hyperglycaemia.
4.2 DOSE AND METHOD OF ADMINISTRATION
Apidra is a recombinant human insulin analogue that has been shown to
be equipotent to
human insulin. After subcutaneous administration it has a more rapid
onset and a shorter
duration of action than regular human insulin.
Apidra is for single patient use only.
Apidra should be given by injection within 15 minutes before or
immediately after a meal.
DOSE
The dosage of Apidra should be individualised and determined based on
the physician’s
advice in accordance with the needs of the patient. Apidra should
normally be used in
regimens that include a longer-acting insulin or basal insulin
analogue.
Apidra should be administered by subcutaneous injection in the
abdominal wall, the thigh or
deltoid. As with all insulins, injection sites within an injection
area (abdomen, thigh, deltoid)
should be rotated from one injection to the next in order to reduce
the risk of lipodystrophy
and localised cutaneous amyloidosis. Do not inject into areas of
lipodystrophy and localised
apidra-ccdsv12-piv13-15feb21
Page 2 of 21
cutaneous amyloidosis. (see Section 4.4 Special warnings and
precautions for use and 4.8
Adverse Effects (Undesirable Effects).
As for all insulins, the rate of absorption, and consequently the
onset and duration of action,
may be affected by injection site, exercise and other variable