Fiasp® Penfill® 100 unitsml Solution for injection

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Insulin Aspart

Boleh didapati daripada:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Insulin Aspart

Unit dalam pakej:

5 Units

Dikeluarkan oleh:

NOVO NORDISK A/S

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
FIASP
®
Insulin Aspart (100 units/ml)
1
WHAT IS IN THIS LEAFLET
1.
What Fiasp
®
is used for
2.
How Fiasp
®
works
3.
Before you use Fiasp
®
4.
How to use Fiasp
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Fiasp
®
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial number
1. WHAT FIASP
® 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.
2. HOW FIASP
® WORKS
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.
3. BEFORE YOU USE FIASP
®
_-_
_ _
_WHEN YOU MUST NOT USE IT_
If you are allergic to insulin aspart
or any of the other ingredients of
this medicine (listed in section 8
_Product description_).
_-_
_ _
_BEFORE YOU START TO USE IT_
Talk to your doctor, pharmacist or
nurse
before
using
Fiasp
®
.
Be
especially aware of the following:

Low
blood
sugar
(hypoglycaemia)
–
If
your
blood sugar is too low, follow
the
guidance
for
low
blood
sugar in section 6_ Side effects._
Fiasp
®
starts to lower blood
sugar faster compared to other
mealtime
insulins.
If
hypoglycaemia
occurs,
you
may experience it earlier after
an injection with Fiasp
®
.

High
blood
sugar
(hyperglycaemia)
–
If
your
blood sugar is too high, follow
the
guidance
for
high
blood
sugar in section 6 _Side effects._

Sw

Ciri produk

1
Fiasp
®
Penfill
®
Professional leaflet_STF-Feb-2021_site Denmark_8-0910-00-004-1
Based on EU text: 20200603_EN_06992_Fiasp_Vers 9-2
1.
NAME OF THE MEDICINAL PRODUCT
FIASP
®
Penfill
®
100 units/ml
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).
One cartridge contains 300 units of insulin aspart in 3 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
Solution for injection (Penfill
®
).
Clear, colourless, aqueous
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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. Fiasp
®
given by subcutaneous injection should be used in combination with
intermediate- or long-acting
insulin given at least once a day. In a basal-bolus treatment regimen
approximately 50% of this
requirement may be provided by Fiasp
®
and the remaining by intermediate- or long-acting insulin.
The individual total daily insulin requirement in adults, adolescents
and children may vary and is
usually between 0.5 and 1.0 unit/kg/day.
Blood glucose monitoring and insulin dose adjustment are recommended
to achieve optimal
glycaemic control.
Adjustment of dose may be necessary if patients undertake increased
physical activity, change their
usual diet or during concomitant illness. Blood glucose levels should
be monitored adequately
under these conditions.
The duration of action will vary according to the dose, injection
site, blood flow, temperature and
level of physical activi