NovoRapid Penfill 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) glass cartridges 3ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-06-27

Patient Information leaflet

Regulatory Operations
Insert: 2010-501,65x150-001
Current 4
Professionel
COLOUR: PMS 280C
NovoRapid® Penfill®
100 U/ml solution for injection in cartridge.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the solution contains 100 U of insulin aspart*
(equivalent to 3.5 mg).
1 cartridge 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 cartridge.
Penfill®.
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 in children and adolescent

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
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 ml solution contains 100 units insulin aspart* (equivalent to 3.5
mg). 1 vial contains 10 ml
equivalent to 1,000 units.
NovoRapid Penfill
1 ml solution contains 100 units insulin aspart* (equivalent to 3.5
mg). 1 cartridge contains 3 ml
equivalent to 300 units.
NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch
1 ml solution contains 100 units insulin aspart* (equivalent to 3.5
mg). 1 pre-filled pen contains 3 ml
equivalent to 300 units.
NovoRapid PumpCart
1 ml solution contains 100 units insulin aspart* (equivalent to 3.5
mg). 1 cartridge contains 1.6 ml
equivalent to 160 units.
*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.
2
3
Moreover NovoRapid can be used for continuous subcutaneous insulin
infusion (CSII) in pump
systems.
It can als