Tresiba ® Flextouch® 200 UmL Solution for Injection

国家: 马来西亚

语言: 英文

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

有效成分:

Insulin Degludec

可用日期:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN（国际名称）:

Insulin Degludec

每包单位数:

3 Pre-Filled Syringes

厂商:

NOVO NORDISK A/S

资料单张

TRESIBA
® FLEXTOUCH
®
SOLUTION FOR INJECTION
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
Insulin Degludec
(100U/ml & 200 U/ml)
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
12.
Serial Number
1. 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.
2. 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.
3. 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 (listed in section 8).
_- 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) – if your blood
sugar
is
too
low,
follow
the
guidance for low blood sugar in
section 6 S_ide effects_.

High
blood
sugar
(hyperglycaemia) – if your blood
sugar
is
too
high,
follow
the
guidance for high blood sugar in
section 6 S_ide effects_.

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,
see
_Thiazolidine

产品特点

Tresiba
®
FlexTouch
®
200 U/ml Professional leaflet EN-Mar-2021 8-9562-00-010-1
Based on EU text: 20210326_EN_07216_TRE_15-3
1 of 23
TRESIBA
®
FlexTouch
®
200 units/ml
Solution for injection in pre-filled pen.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 200 units insulin degludec* (equivalent to 7.32
mg insulin degludec).
One pre-filled pen contains 600 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