Levemir FlexPen solution for injection

Land: Armenien

Språk: engelska

Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiva substanser:

insulin detemir (recombinant)

Tillgänglig från:

Novo Nordisk A/S

ATC-kod:

A10AE05

INN (International namn):

insulin detemir (recombinant)

Dos:

100U/ml

Läkemedelsform:

solution for injection

Enheter i paketet:

(5) pre-filled pen 3ml

Receptbelagda typ:

Prescription

Bemyndigande status:

Registered

Tillstånd datum:

2018-08-08

Bipacksedel

Levemir
®
FlexPen
®
Professional leaflet EN-Aug-2021_site Denmark_8-9678-00-012-1
Based on EU text: 20210406_EN_07209_LEV_42-5
1
LEVEMIR
®
_ _
FlexPen
®
100 U/ml, solution for injection in pre-filled pen
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the solution contains 100 U of insulin detemir* (equivalent to
14.2 mg).
1 pre-filled pen contains 3 ml equivalent to 300 U.
*Insulin detemir is produced by recombinant DNA technology in
_Saccharomyces cerevisiae._
1 unit (U) of insulin detemir corresponds to 1 international unit (IU)
of human insulin.
PHARMACEUTICAL FORM
Clear, colourless, neutral solution for injection in pre-filled pen.
FlexPen
®
.
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
aged 1 year and above.
POSOLOGY
Levemir
®
is a soluble, basal insulin analogue with a prolonged duration of
effect (up to 24 hours).
Compared to other insulin products, basal-bolus therapy with Levemir
®
is not associated with weight gain.
The lower risk of nocturnal hypoglycaemia compared to NPH (Neutral
Protamine Hagedorn) insulin allows a
more intensive titration towards target blood glucose levels for
basal-bolus therapy.
Levemir
®
provides better glycaemic control as measured by Fasting Plasma
Glucose (FPG) compared to
NPH insulin treatment.
Levemir
®
can be used alone as the basal insulin or in combination with bolus
insulin. It can also be used in
combination with oral antidiabetic medicinal products and/or GLP-1
receptor agonists.
DOSAGE
When Levemir
®
is used in combination with oral antidiabetic medicinal products or
when added to GLP-1
receptor agonists, it is recommended to use Levemir
®
once daily, initially at a dose of 0.1–0.2 U/kg, or of 10
U IN ADULT PATIENTS. The dose of Levemir
®
should be titrated based on the individual patient’s needs.
When a GLP-1 receptor agonist is added to Levemir
®
, it is recommended to reduce the dose of Levemir
®
by
20% to minimise the risk of hypoglycaemia. Subsequently, dosage should
be adjusted individually.
For

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Levemir Penfill 100 units/ml solution for injection in cartridge.
Levemir FlexPen 100 units/ml solution for injection in pre-filled pen.
Levemir InnoLet 100 units/ml solution for injection in pre-filled pen.
Levemir FlexTouch 100 units/ml solution for injection in pre-filled
pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levemir Penfill
1 ml of the solution contains 100 units insulin detemir* (equivalent
to 14.2 mg). 1 cartridge contains
3 ml equivalent to 300 units.
Levemir FlexPen/Levemir InnoLet/Levemir FlexTouch
1 ml of the solution contains 100 units insulin detemir* (equivalent
to 14.2 mg). 1 pre-filled pen
contains 3 ml equivalent to 300 units.
*Insulin detemir is produced in _Saccharomyces cerevisiae _by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear, colourless and aqueous.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levemir is indicated for treatment of diabetes mellitus in adults,
adolescents and children aged 1 year
and above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The potency of insulin analogues, including insulin detemir, is
expressed in units, whereas the potency
of human insulin is expressed in international units. 1 unit insulin
detemir corresponds to
1 international unit of human insulin.
Levemir can be used alone as the basal insulin or in combination with
bolus insulin. It can also be used
in combination with oral antidiabetic medicinal products and/or GLP-1
receptor agonists.
When Levemir is used in combination with oral antidiabetic medicinal
products or when added to
GLP-1 receptor agonists it is recommended to use Levemir once daily,
initially at a dose of 0.1–
0.2 units/kg or of 10 units IN ADULT PATIENTS. The dose of Levemir
should be titrated based on the
individual patient’s needs.
When a GLP-1 receptor agonist is added to Levemir, it is recommended
to reduce the dose of Levemir
by