NOVORAPID

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

INSULIN ASPART

Available from:

NOVO NORDISK LTD., ISRAEL

ATC code:

A10AB05

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

INSULIN ASPART 100 U/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

NOVO NORDISK A/S, DENMARK

Therapeutic area:

INSULIN ASPART

Therapeutic indications:

Treatment of patients with diabetes mellitus in adults, adolescents and children aged 2 years and above.

Authorization date:

2020-06-30

Patient Information leaflet

NovoRapid FLEX IL PIL FEB-2021 Notification
Page 1 of 15
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) -
1986
The dispensing of this medicine requires a doctor’s prescription
NovoRapid
®
FlexPen
®
100 units/ml
Solution for injection in pre-filled pen
Active substance: Insulin aspart 100 units/ml
Inactive substances and allergens in this medicine: see section 2
“Important
information about some of this medicine's ingredients” and section 6
"Additional
information".

Read all of this leaflet carefully before you start using this
medicine. This
leaflet contains concise information about this medicine. If you have
any further
questions, consult your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if it seems to that their medical condition is
similar to yours.

This medicine is intended for adults, adolescents, and children over
two years
old.
1. What is this medicine intended for?
NovoRapid is used to reduce high blood sugar level in adults,
adolescents and
children aged 2 years and above with diabetes.
Therapeutic group: Medicines for the treatment of diabetes.
Fast-acting insulins and
insulin analogs for injection.
NovoRapid is a modern insulin (insulin analog) with a rapid-acting
effect. Modern
insulin products are improved versions of human insulin.
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.
NovoRapid FLEX IL PIL FEB-2021 Notification
Page 2 of 15
2. Before using this medicine
Do not use this medicine if:

You are sensitive (

Summary of Product characteristics

NovoRapid IL SPC FEB-2021-NOTIFICATION EMA SmpC
Page
1
of
13
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
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
1 pre-filled pen contains 3 ml equivalent to 300 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
Treatment of patients with diabetes mellitus in adults, adolescents
and children aged 2 years 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.
Moreover NovoRapid vial can be used for continuous subcutaneous
insulin infusion (CSII) in pump
systems.
NovoRapid vial can also be used if intravenous administration of
insulin aspart, by physicians or
other healthcare staff, is applicable.
NovoRapid IL SPC FEB-2021-NOTIFICATION EMA SmpC
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Blood glucose monitoring and insulin dose adjustments are recommended
to achieve optimal
glycaemic control.
The individual insulin requirement in adults and children is usually
between 0.5 and 1.0