NovoRapid FlexPen solution for s/c or i/v injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

insulin aspart

Available from:

Novo Nordisk A/S

ATC code:

A10AB05

INN (International Name):

insulin aspart

Dosage:

100U/ml

Pharmaceutical form:

solution for s/c or i/v injection

Units in package:

(5) pre-filled pens 3ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-06-27

Patient Information leaflet

NovoRapid
®
FlexPen
®
Professional Leaflet STF-Mar-2018_site Denmark_8-9670-00-014-1
1
NOVORAPID
®
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 aspart* (equivalent to
3.5 mg).
1 pre-filled pen contains 3 ml equivalent to 300 U.
*Insulin aspart is produced by recombinant DNA technology in
_Saccharomyces cerevisiae._
PHARMACEUTICAL FORM
Clear, colourless, aqueous 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
NovoRapid
®
is a rapid-acting insulin analogue. NovoRapid
®
dosage is individual and determined in
accordance with the needs of the patient. It should normally be used
in combination with intermediate-acting
or long-acting insulin given at least once a day. Blood glucose
monitoring and insulin dose adjustment are
recommended to achieve optimal glycaemic control.
The individual insulin requirement in adults and children is usually
between 0.5 and 1.0 U/kg/day. In a basal-
bolus treatment regimen, 50–70% of this requirement may be provided
by NovoRapid
®
and the remainder by
intermediate-acting or long-acting insulin. Adjustment of dosage may
be necessary if patients undertake
increased physical activity, change their usual diet or during
concomitant illness.
NovoRapid
®
has a faster onset and a shorter duration of action than soluble human
insulin.
Due to the faster onset of action, NovoRapid
®
should generally be given immediately before a meal. When
necessary NovoRapid
®
can be given soon after a meal.
Due to the shorter duration, NovoRapid
®
has a lower risk of causing nocturnal hypoglycaemic episodes.
SPECIAL POPULATIONS
As with all insulin products, in elderly patients and patients with
renal or hepatic impairment, glucose
monitoring should be intensified and the insulin aspart dosage
adjusted on an individual basis.
PAEDIATRIC POPULATION
NovoRapid
®
can be used

Summary of Product characteristics

1
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
2
1.
NAME OF THE MEDICINAL PRODUCT
NovoRapid 100 units/ml solution for injection in vial
NovoRapid Penfill 100 units/ml solution for injection in cartridge
NovoRapid FlexPen 100 units/ml solution for injection in pre-filled
pen
NovoRapid InnoLet 100 units/ml solution for injection in pre-filled
pen
NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled
pen
NovoRapid PumpCart 100 units/ml solution for injection in cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NovoRapid vial
1 vial contains 10 ml equivalent to 1,000 units.1 ml solution contains
100 units insulin aspart*
(equivalent to 3.5 mg).
NovoRapid Penfill
1 cartridge contains 3 ml equivalent to 300 units.1 ml solution
contains 100 units insulin aspart*
(equivalent to 3.5 mg).
NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch
1 pre-filled pen contains 3 ml equivalent to 300 units.1 ml solution
contains 100 units insulin aspart*
(equivalent to 3.5 mg).
NovoRapid PumpCart
1 cartridge contains 1.6 ml equivalent to 160 units.1 ml solution
contains 100 units insulin aspart*
(equivalent to 3.5 mg).
*Insulin aspart 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
NovoRapid 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 aspart, is
expressed in units, whereas the potency
of human insulin is expressed in international units.
NovoRapid dosing is individual and determined in accordance with the
needs of the patient. It should
normally be used in combination with intermediate-acting or
long-acting insulin.
3
3
Moreover NovoRapid vial and NovoRapid PumpCart can be used for
continuous subcutaneous insulin
infusion (CSII) i