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

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

Insulin detemir, Quantity: 100 U/mL

Fáanlegur frá:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (Alþjóðlegt nafn):

Insulin detemir

Lyfjaform:

Injection, solution

Samsetning:

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

Stjórnsýsluleið:

Subcutaneous

Einingar í pakka:

5 x 3mL multidose cartridge

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

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

Vörulýsing:

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

Leyfisstaða:

Registered

Leyfisdagur:

2011-09-09

Upplýsingar fylgiseðill

Consumer Medicine Information
Levemir Penfill (LevPfcmi12).docx
Page 1 of 7
LEVEMIR
® PENFILL
®
_insulin detemir (rys)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT LEVEMIR
® IS USED FOR ....... 1
BEFORE
YOU
USE
LEVEMIR
®
PENFILL
® ....................................... 1
HOW TO USE LEVEMIR
® PENFILL
® .. 3
WHILE YOU ARE USING LEVEMIR
®
PENFILL
® ....................................... 5
THINGS TO BE CAREFUL OF .............. 5
SIDE EFFECTS ................................. 6
AFTER USING LEVEMIR
® PENFILL
®
.. 6
PRODUCT DESCRIPTION .................. 7
FURTHER INFORMATION ................. 7
This
leaflet
answers
some
common
questions
about
Levemir
®
Penfill
®
.
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
®
Penfill
®
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
®
Penfill
®
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 control
their blood sugar levels.
Some
patients
with
type
2

Vara einkenni

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