Levemir FlexPen

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

insulin detemir (recombinant)

Доступна с:

Novo Nordisk A/S

ИНН (Международная Имя):

insulin detemir (recombinant)

дозировка:

100IU/ml

Фармацевтическая форма:

solution for injection

Тип рецепта:

Prescription

Характеристики продукта

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
2
1.
NAME OF THE MEDICINAL PRODUCT
Levemir_ _100 units/ml solution for injection in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 in pre-filled pen. FlexPen.
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 20% to minimise the risk of hypoglycaemia. Subsequently, dosage
should be adjusted individually.
For individual dose adjustments, the following two titration
guidelines are recommended FOR ADULTS:
ADULT TYPE 1 AND TYPE 2 DIABETES TITRATION GUIDELINE:
Average pre-breakfast SMPG*
Levemir dose adjustment
> 10.0 mmol/l (180 mg/dl)
+ 8 units
9.1-10.0 mmol/l (163-180 mg/dl)
+ 6 units
2
3
8.1