Fiasp

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

insulin aspart

Beschikbaar vanaf:

Novo Nordisk A/S

ATC-code:

A10AB05

INN (Algemene Internationale Benaming):

insulin aspart

Therapeutische categorie:

Drugs used in diabetes, Insulins and analogues for injection, fast-acting

Therapeutisch gebied:

Diabetes Mellitus

therapeutische indicaties:

Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Product samenvatting:

Revision: 8

Autorisatie-status:

Authorised

Autorisatie datum:

2017-01-09

Bijsluiter

52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FIASP 100
UNITS/ML FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN
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, pharmacist or
nurse.
–
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
What Fiasp is and what it is used for
2
What you need to know before you use Fiasp
3
How to use Fiasp
4
Possible side effects
5
How to store Fiasp
6
Contents of the pack and other information
1.
WHAT FIASP IS AND WHAT IT IS USED FOR
Fiasp is a mealtime insulin with a fast-acting blood sugar lowering
effect. Fiasp is a solution for
injection containing insulin aspart and is used to treat diabetes
mellitus in adults, adolescents and
children aged 1 year and above. Diabetes is a disease where your body
does not produce enough
insulin to control the level of blood sugar. Treatment with Fiasp
helps to prevent complications from
your diabetes.
Fiasp should be injected up to 2 minutes before the start of the meal,
with an option to inject up to
20 minutes after starting the meal.
This medicine has its maximum effect between 1 and 3 hours after the
injection and the effect lasts for
3 to 5 hours.
This medicine should normally be used in combination with
intermediate-acting or long-acting insulin
preparations.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FIASP
_ _
DO NOT USE FIASP
•
if you are allergic to insulin aspart, or any of the other ingredients
of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Fiasp. Be
especially awa

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fiasp 100 units/mL FlexTouch solution for injection in pre-filled pen
Fiasp 100 units/mL Penfill solution for injection in cartridge
Fiasp 100 units/mL solution for injection in vial
Fiasp 100 units/mL PumpCart solution for injection in cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of the solution contains 100 units of insulin aspart* (equivalent
to 3.5 mg).
Fiasp 100 units/mL FlexTouch solution for injection in pre-filled pen
Each pre-filled pen contains 300 units of insulin aspart in 3 mL
solution.
Fiasp 100 units/mL Penfill solution for injection in cartridge
Each cartridge contains 300 units of insulin aspart in 3 mL solution.
Fiasp 100 units/mL solution for injection in vial
Each vial contains 1,000 units of insulin aspart in 10 mL solution.
Fiasp 100 units/mL PumpCart solution for injection in cartridge
Each cartridge contains 160 units of insulin aspart in 1.6 mL
solution.
*Insulin aspart is produced in
_Saccharomyces cerevisiae _
by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Fiasp 100 units/mL FlexTouch solution for injection in pre-filled pen
Solution for injection (FlexTouch).
Fiasp 100 units/mL Penfill solution for injection in cartridge
Solution for injection (Penfill).
Fiasp 100 units/mL solution for injection in vial
Solution for injection.
Fiasp 100 units/mL PumpCart solution for injection in cartridge
Solution for injection (PumpCart).
Clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
3
Treatment of diabetes mellitus in adults, adolescents and children
aged 1 year and above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Fiasp is a mealtime insulin for subcutaneous administration up to 2
minutes before the start of the
meal, with the option to administer up to 20 minutes after starting
the meal (see section 5.1).
Dosing with Fiasp is individual and determined in accordance with the
needs of the patient. Fia