LEVEMIR FLEXPEN insulin detemir (rys) 100 U/mL injection cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Insulin detemir, Quantity: 100 U/mL

Available from:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (International Name):

Insulin detemir

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: glycerol; sodium hydroxide; dibasic sodium phosphate dihydrate; water for injections; hydrochloric acid; zinc acetate; metacresol; phenol; sodium chloride

Administration route:

Subcutaneous

Units in package:

5 x 3mL multidose cartridge

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of diabetes mellitus. (See 'Pharmacology' and 'Clinical Trials.')

Product summary:

Visual Identification: Clear colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2011-09-09

Patient Information leaflet

Consumer Medicine Information
Page 1 of 2
Levemir FlexPen (LevFpcmi14).docx
LEVEMIR
® FLEXPEN
®
_insulin detemir (rys)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT LEVEMIR
® IS USED FOR ....... 1
BEFORE YOU USE LEVEMIR
® FLEXPEN
® .................................................... 1
HOW TO USE LEVEMIR
® FLEXPEN
® 2
WHILE
YOU
ARE
USING
LEVEMIR
®
FLEXPEN
® .................................... 4
SIDE EFFECTS ................................. 5
AFTER
USING
LEVEMIR
®
FLEXPEN
® .................................................... 5
PRODUCT DESCRIPTION .................. 6
FURTHER INFORMATION ................. 6
INSTRUCTIONS FOR USE .................. 7
This leaflet answers some common
questions about Levemir
®
FlexPen
®
.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
using
Levemir
®
FlexPen
®
against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING
THIS
MEDICINE,
ASK
YOUR
DOCTOR,
DIABETES
EDUCATION
NURSE
OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT LEVEMIR
® IS USED
FOR
The
insulin
detemir
(rys),
or
“Levemir
®
”, in Levemir
®
FlexPen
®
is a long-acting insulin used to treat
diabetes mellitus. It may be used in
combination
with
oral
antidiabetic
medicines
(diabetes
tablets)
or
as
add-on
therapy
to
liraglutide
(Victoza
®
),
which
is
used
to
treat
type 2 diabetes mellitus in adults.
Levemir
®
can also be used with a
meal-related
short-
or
rapid-acting
insulin such as NovoRapid
®
.
Diabetes
mellitus
is
a
condition
where
your
pancreas
does
not
produce
enough
insulin
to
control
your
blood
sugar
(glucose)
level.
Extra insulin is therefore needed.
There
are
two
types
of
diabetes
mellitus:
Type
1
diabetes
–
also
called
juvenile onset diabetes
Type
2
diabetes
–
also
called
maturity onset diabetes.
Patients with type 1 diabetes always
require insulin to con

Summary of Product characteristics

Levemir
®
Product Information
Levpi11.docx
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
Levemir
®
FlexPen
®
(insulin detemir (rys)) solution for injection
Levemir
®
Penfill
®
(insulin detemir (rys)) solution for injection
1
NAME OF THE MEDICINE
insulin detemir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levemir is a soluble, basal insulin analogue with a prolonged duration
of effect. Insulin detemir (rys)
is produced by recombinant DNA technology using Saccharomyces
cerevisiae.
One unit of insulin detemir contains 0.142 mg salt-free anhydrous
insulin detemir. One unit (U) of
insulin detemir corresponds nominally to one IU (international unit)
of human insulin.
Levemir also contains the following inactive ingredients: glycerol,
phenol, metacresol, zinc acetate,
dibasic sodium phosphate dihydrate, sodium chloride, hydrochloric
acid, sodium hydroxide and water
for injections.
3
PHARMACEUTICAL FORM
Levemir is a clear, colourless, neutral solution of insulin detemir
100 U/mL. Levemir is a solution for
injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus. (See section 5 - Pharmacological
Properties and section 5.1 -
Pharmacodynamic Properties, Clinical trials.)
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Levemir is a long-acting insulin analogue used alone as a basal
insulin or in combination with bolus
insulin. It can also be used in combination with oral antidiabetic
drugs (OADs) or as add-on therapy to
liraglutide.
_ _
For patients with type 1 diabetes mellitus, Levemir must be used in
combination with rapid- or short-
acting insulin.
When Levemir is used as part of a basal-bolus insulin regimen Levemir
should be administered once or
twice daily depending on patients’ needs. Dosage of Levemir should
be adjusted individually. For
patients who require twice daily dosing to optimise blood glucose
control, the evening dose can be
administered either with the evening meal, at bedtime, or 12 hours
after the morning dose.
In combination with OADs or as add on therapy to liraglu