Levemir Flexpen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Insulin detemir 100 U/mL

Available from:

Novo Nordisk Pharmaceuticals Ltd

INN (International Name):

Insulin detemir 100 U/mL

Dosage:

100 U/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Insulin detemir 100 U/mL Excipient: Dibasic sodium phosphate dihydrate Glycerol Hydrochloric acid Metacresol Phenol Sodium chloride Sodium hydroxide Water for injection Zinc

Units in package:

Cartridge, 5 x 3mL with disposable pen, 15 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Novo Nordisk A/S

Therapeutic indications:

For the treatment of diabetes mellitus

Product summary:

Package - Contents - Shelf Life: Cartridge, 5 x 3mL with disposable pen - 15 mL - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 weeks opened stored at or below 30°C protect from light 4 weeks opened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2002-12-18

Patient Information leaflet

Consumer Medicine Information
Page 2 of 11
Levemir FlexPen (LevFpcmi14).docx
LEVEMIR
® FLEXPEN
®
_insulin detemir (rys)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT LEVEMIR
® IS USED FOR ....... 2
BEFORE YOU USE LEVEMIR
® FLEXPEN
® .................................................... 2
HOW TO USE LEVEMIR
® FLEXPEN
® 4
WHILE
YOU
ARE
USING
LEVEMIR
®
FLEXPEN
® .................................... 5
SIDE EFFECTS ................................. 6
AFTER
USING
LEVEMIR
®
FLEXPEN
® .................................................... 6
PRODUCT DESCRIPTION .................. 7
FURTHER INFORMATION ................. 7
INSTRUCTIONS FOR USE .................. 8
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 co

Summary of Product characteristics

LEVEMIR 20.4.2021.doc
2
NEW ZEALAND DATASHEET
1 PRODUCT NAME
LEVEMIR
®
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin detemir (rys) 100 Units/mL
Recombinant DNA origin: _Saccharomyces cerevisiae _
_ _
3 PHARMACEUTICAL FORM
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.
Levemir is a clear, colourless, neutral solution of insulin detemir
100 U/mL. Levemir is a
solution for injection. 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 of human
insulin. Levemir is presented in 3 mL Penfill
®
cartridges made of glass, closed with a rubber
disc. The Penfill cartridges are designed to be used with Novo Nordisk
insulin delivery
systems and are also included in the FlexPen
®
pre-filled syringes.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of diabetes mellitus (See Pharmacodynamic properties).
4.2 Dose and method of administration
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 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 liraglutide in type 2
diabetes it is
recommended to initiate Levemir treatment with once daily
administration at a dose of 10 U
or 0.1-0.2 U/kg. The dose of Levemir should be titrated based on
individual patients’ n