Tresiba® FlexTouch® 100 Uml Solution for Injection

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

Insulin Degludec

Mevcut itibaren:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (International Adı):

Insulin Degludec

Paketteki üniteler:

1 unit x 3ml Pre-Filled Pen; 5 unit x 3ml Pre-Filled Pen

Tarafından üretildi:

Novo Nordisk Production SAS

Bilgilendirme broşürü

TRESIBA® FLEXTOUCH®
SOLUTION FOR INJECTION
Insulin Degludec
(100U/ml & 200 U/ml)
_Consumer Medication Information Leaflet (RiMUP)_
1
WHAT IS IN THIS LEAFLET
1.
What Tresiba
®
is used for
2.
How Tresiba
®
works
3.
Before you use Tresiba
®
4.
How to use Tresiba
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Tresiba
®
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT TRESIBA
® IS USED FOR
It is used to treat diabetes mellitus
in adults, adolescents and children
aged 1 year and above. Tresiba
®
helps
your
body
reduce
your
blood sugar level.
HOW TRESIBA
® WORKS
Tresiba
®
is a long-acting basal insulin
called insulin degludec. It is used for
once-daily
dosing.
On
occasions
when you cannot follow your regular
dosing schedule you can change the
time of dosing because Tresiba
®
has a
long blood-sugar-lowering effect.
In type 2 diabetes mellitus, Tresiba
®
may
be
used
in
combination
with
tablets for diabetes or with injectable
antidiabetic
products
other
than
insulin.
In type 1 diabetes mellitus, Tresiba
®
must always be used in combination
with meal-related rapid acting insulin
products.
BEFORE YOU USE TRESIBA
®
_ _
_- WHEN YOU MUST NOT USE IT _
If you are allergic to insulin degludec
or any of the other ingredients of this
medicine.
_- BEFORE YOU START TO USE IT _
Talk to your doctor, pharmacist or
nurse
before
using
Tresiba
®
.
Be
especially aware of the following:
►Low blood sugar (hypoglycaemia).
►High
blood
sugar
(hyperglycaemia).
►Switching
from
other
insulin
products – The insulin dose may need
to
be
changed
if you
switch
from
another type, brand or manufacturer
of insulin. Talk to your doctor.
►Thiazolidinediones
used
together
with insulin.
►Eye disorder – Fast improvements
in blood sugar control may lead to a
temporary worsening of diabetic eye
disorder.
If
you
experience
eye
problems, talk to your doctor.
►Ensuring you use the right type of
insulin – Always check the insulin
label before each injection to avo

Ürün özellikleri

Tresiba
®
FlexTouch
®
100 U/ml Professional leaflet STF-Feb-2018
1 of 23
TRESIBA
®
FlexTouch
®
100 units/ml
Solution for injection in pre-filled pen.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 100 units insulin degludec* (equivalent to 3.66
mg insulin degludec).
One pre-filled pen contains 300 units of insulin degludec in 3 ml
solution.
*Produced in
_Saccharomyces cerevisiae_
by recombinant DNA technology.
For the full list of excipients, see
_List of excipients._
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, neutral solution.
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
from the age of 1 year.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Tresiba
®
is a basal insulin for once-daily subcutaneous administration at any
time of the day, preferably at
the same time every day.
The potency of insulin analogues, including insulin degludec, is
expressed in units (U). One (1) unit (U) of
insulin degludec corresponds to 1 international unit (IU) of human
insulin, 1 unit of insulin glargine (100
units/ml) or 1 unit of insulin detemir.
In patients with type 2 diabetes mellitus, Tresiba
®
can be administered alone or in any combination with oral
antidiabetic medicinal products, GLP-1 receptor agonists and bolus
insulin (see
_Pharmacodynamic _
_properties_
).
In type 1 diabetes mellitus, Tresiba
®
must be combined with short-/rapid-acting insulin to cover mealtime
insulin requirements.
Tresiba
®
is to be dosed in accordance with the individual patient’s needs. It
is recommended to optimise
glycaemic control via dose adjustment based on fasting plasma glucose
(FPG).
As with all insulin products, adjustment of dose may be necessary if
patients undertake increased physical
activity, change their usual diet or during concomitant illness.
_ _
_Tresiba_
_®_
_ 100 units/ml and Tresiba_
_®_
_ 200 units/ml _
Tresiba
®
is available in two strengths. For both, the needed dose is dialled in
units. The dose steps, however,
differ between the t