NovoRapid

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

insulin aspart

Available from:

Novo Nordisk A/S

ATC code:

A10AB05

INN (International Name):

insulin aspart

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus

Therapeutic indications:

NovoRapid is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Product summary:

Revision: 32

Authorization status:

Authorised

Authorization date:

1999-09-07

Patient Information leaflet

56
B. PACKAGE LEAFLET
57
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVORAPID 100 UNITS/ML SOLUTION FOR INJECTION IN VIAL
insulin aspart
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, nurse or
pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk with your doctor, nurse or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What NovoRapid is and what it is used for
2.
What you need to know before you use NovoRapid
3.
How to use NovoRapid
4.
Possible side effects
5.
How to store NovoRapid
6.
Contents of the pack and other information
1.
WHAT NOVORAPID IS AND WHAT IT IS USED FOR
NovoRapid is a modern insulin (insulin analogue) with a rapid-acting
effect. Modern insulin products
are improved versions of human insulin.
NovoRapid is used to reduce the high blood sugar level in adults,
adolescents and children aged 1 year
and above with diabetes mellitus (diabetes). Diabetes is a disease
where your body does not produce
enough insulin to control the level of your blood sugar. Treatment
with NovoRapid helps to prevent
complications from your diabetes.
NovoRapid will start to lower your blood sugar 10–20 minutes after
you inject it, a maximum effect
occurs between 1 and 3 hours after the injection and the effect lasts
for 3–5 hours. Due to this short
action NovoRapid should normally be taken in combination with
intermediate-acting or long-acting
insulin preparations. Moreover NovoRapid can be used for continuous
infusion in a pump system.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NOVORAPID
DO NOT USE NOVORAPID
►
If you are allergic to insulin aspart, or any of the other ingredients
in this medicine (see section
6, Conten

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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
Moreover NovoRapid vial and NovoRapid PumpCart can be used for
continuous subcutaneous insulin
infusion (CSII) in pum