LEVEMIR® FLEXPEN® 100UML 3ML

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

Insulin Detemir

Prieinama:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

ATC kodas:

A10AE05

Dozė:

14.2 mg/ml

Vaisto forma:

INJECTION, SOLUTION

Sudėtis:

Insulin Detemir 14.2 mg/ml

Vartojimo būdas:

SUBCUTANEOUS

Recepto tipas:

Prescription Only

Pagaminta:

Novo Nordisk A/S

Autorizacija statusas:

ACTIVE

Leidimo data:

2005-06-13

Pakuotės lapelis

 
1 
LEVEMIR
®
_ _FLEXPEN
®

100 U/ml Solution for injection in pre-filled pen 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
1 ml contains 100 U of insulin detemir *(Equivalent to 14.2mg). 
1 pre-filled pen contains 3 ml equivalent to 300 U. 
*Insulin detemir,rDNA( 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 2 years and above. 

POSOLOGY  
Levemir
®
 is a soluble, basal insulin analogue with  a prolonged duration of
effect(up to 24 hours). 

Levemir
®
 can be used alone as the basal insulin or in combination with
bolus insulin. It can also be used in 
combination with oral anti-diabetic medicines or as add-on therapy
to liraglutide treatment.

DOSAGE 
In combination with oral anti-diabetic medicines or as add-on
to liraglutide , it is recommended to use 
Levemir
®
 once daily, initially at a dose of 10 U or 0.1-0.2 U/kg. The dose
of Levemir
®
 should be titrated 
based on individual patients’ needs. 

Based on study results, the following titration guideline is
recommended : 

_ADULT TITRATION GUIDELINE _

AVERAGE PRE-BREAKFAST SMPG* 
LEVEMIR
®
 DOSE ADJUSTMENT 
  > 10.0 mmol/l (180 mg/dl) 
+ 8 U 
  9.1-10.0 mmol/l (163-180 mg/dl) 
+ 6 U 
  8.1-9.0 mmol/l (145-162 mg/dl) 
+ 4 U 
  7.1-8.0 mmol/l (127-144 mg/dl) 
+ 2 U 
  6.1-7.0 mmol/l (109-126 mg/dl) 
+ 2 U 
If one SMPG measurement 

  3.1-4.0 mmol/l (56-72 mg/dl) 
- 2 U 
  < 3.1 mmol/l (< 56 mg/dl) 
- 4 U 
* Self-monitored Plasma Glucose  

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 Leve

Prekės savybės

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 2 years and above.
POSOLOGY
Levemir
®
is a soluble, basal insulin analogue with a prolonged duration of
effect (up to 24 hours).
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 individual dose adjustments, the following two titration
guidelines are recommended
FOR ADULTS:
ADULT TYPE 2 DIABETES TITRATION GUIDELINE:
AVERAGE PRE-BREAKFAST SMPG*
LEVEMIR
® DOSE ADJUSTMENT
> 10.0 mmol/l (180 mg/dl)
+8 U
9.1–10.0 mmol/l (163–180 mg/dl)
+6 U
8.1–9.0 mmol/l (145–162 mg/dl)
+4 U
7.1–8.0 mmol/l (127–144 mg/dl)
+2 U
6.1–7.0 mmol/l (109–126 mg/dl)
+2 U
4.1–6.0 mmol/l (73–108 mg/dl)
no change (target)
If one SMPG measurement
3.1–4.0 mmol/l (56–72 mg/dl)
-2 U
< 3.1 mmol/l (< 56 mg/dl)
-4 U
* Self-Monitored