Insulin aspart Sanofi

Kraj: Unia Europejska

Język: angielski

Źródło: EMA (European Medicines Agency)

Składnik aktywny:

insulin aspart

Dostępny od:

Sanofi Winthrop Industrie

Kod ATC:

A10AB05

INN (International Nazwa):

insulin aspart

Grupa terapeutyczna:

Drugs used in diabetes

Dziedzina terapeutyczna:

Diabetes Mellitus

Wskazania:

Insulin aspart Sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Podsumowanie produktu:

Revision: 4

Status autoryzacji:

Authorised

Data autoryzacji:

2020-06-25

Ulotka dla pacjenta

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
INSULIN ASPART SANOFI 100 UNITS/ML SOLUTION FOR INJECTION IN VIAL
insulin aspart
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 to 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 Insulin aspart Sanofi is and what it is used for
2.
What you need to know before you use Insulin aspart Sanofi
3.
How to use Insulin aspart Sanofi
4.
Possible side effects
5.
How to store Insulin aspart Sanofi
6.
Contents of the pack and other information
1.
WHAT INSULIN ASPART SANOFI IS AND WHAT IT IS USED FOR
Insulin aspart Sanofi is a modern insulin (insulin analogue) with a
rapid-acting effect. Modern insulin
products are improved versions of human insulin.
Insulin aspart Sanofi 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 nsulin aspart helps
to prevent complications from your diabetes.
Insulin aspart 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 insulin aspart should normally be taken in comb

Charakterystyka produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Insulin aspart Sanofi 100 units/ml solution for injection in vial
Insulin aspart Sanofi 100 units/ml solution for injection in cartridge
Insulin aspart Sanofi 100 units/ml solution for injection in
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 100 units insulin aspart* (equivalent to 3.5
mg).
Insulin aspart Sanofi 100 units/ml solution for injection in vial
Each vial contains 10 ml equivalent to 1,000 units insulin aspart.
Insulin aspart Sanofi 100 units/ml solution for injection in cartridge
Each cartridge contains 3 ml equivalent to 300 units insulin aspart.
Insulin aspart Sanofi 100 units/m
l solution for injection in pre-filled pen
Each pre-filled pen contains 3 ml equivalent to 300 units insulin
aspart.
Each pre-filled pen delivers 1-80 units in steps of 1 unit.
*produced in
_Escherichia coli_
by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Insulin aspart Sanofi is indicated for the 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.
Insulin aspart Sanofi 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, Insulin aspart Sanofi vial can be used for continuous
subcutaneous insulin infusion (CSII