Ryzodeg® FlexTouch® 100 Uml Solution for Injection

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

INSULIN ASPART; Insulin Degludec

Sẵn có từ:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Tên quốc tế):

INSULIN ASPART; Insulin Degludec

Các đơn vị trong gói:

1 Pre-Filled Syringes; 5 Pre-Filled Syringes

Sản xuất bởi:

NOVO NORDISK A/S

Tờ rơi thông tin

RYZODEG
®
FlexTouch
®
100 UNITS/ML
SOLUTION FOR INJECTION IN PRE-FILLED PEN
_ _
_ _
_ Consumer Medication Information Leaflet (RiMUP) _
insulin degludec/insulin aspart_ _
1
WHAT IS IN THIS LEAFLET
1.
What Ryzodeg
®
is used for
2.
How Ryzodeg
®
works
3.
Before you use Ryzodeg
®
4.
How to use Ryzodeg
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Ryzodeg
®
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1. WHAT RYZODEG
® IS USED FOR
Ryzodeg
®
is used to treat diabetes
mellitus in adults, adolescents and
children from the age of 2 years.
Ryzodeg
®
helps your body reduce
your blood sugar level.
2. HOW RYZODEG
® WORKS
Ryzodeg
®
contains
two
types
of
insulin:

Basal
insulin
called
insulin
degludec – this has a long blood-
sugar-lowering effect.

Rapid-acting
insulin
called
insulin aspart – this lowers your
blood sugar soon after you inject
it.
3. BEFORE YOU USE RYZODEG
®
_ _
_- WHEN YOU MUST NOT USE IT _
►
If
you
are
allergic
to
insulin
degludec, insulin aspart 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
Ryzodeg
®
.
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_ Side 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
_Thiazolidinediones_ below.

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

Đặc tính sản phẩm

Ryzodeg
®
FlexTouch
®
100 U/ml Professional Leaflet STF-Dec-2020 8-9564-00-009-1
Based on EU text: 20200618_EN_06949_RYZ_12-3
1 of 22
1.
NAME OF THE MEDICINAL PRODUCT
RYZODEG
®
FlexTouch
®
100 units/ml
Solution for injection in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 100 units insulin degludec/insulin aspart* in
the ratio 70/30 (equivalent to 2.56 mg
insulin degludec and 1.05 mg insulin aspart).
One pre-filled pen contains 300 units of insulin degludec/insulin
aspart in 3 ml solution.
*Produced in _Saccharomyces cerevisiae _by recombinant DNA technology.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, neutral solution.
4.
CLINICAL PARTICULARES
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
from the age of 2 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Ryzodeg
®
is a soluble insulin product consisting of the basal insulin degludec
and the rapid-acting prandial
insulin aspart.
The potency of insulin analogues, including Ryzodeg
®
, is expressed in units. One (1) unit of this insulin
corresponds to 1 international unit of human insulin, 1 unit of
insulin glargine, 1 unit of insulin detemir or
1 unit of biphasic insulin aspart.
Ryzodeg
®
is to be dosed in accordance with the individual patient’s needs.
Dose-adjustments are
recommended to be based on fasting plasma glucose measurements.
Adjustment of dose may be necessary if patients undertake increased
physical activity, change their usual
diet or during concomitant illness.
_Patients with type 2 diabetes mellitus_
Ryzodeg
®
can be administered once or twice daily with the main meal(s) alone,
in combination with oral
antidiabetic medicinal products, and in combination with bolus insulin
(see section 5.1). When using
Ryzodeg
®
once-daily, changing to twice daily should be considered when higher
doses are needed, e.g. to
avoid hypoglycaemia. Split the dose based on individual patient’s
ne