TREGLUDEC 100UML

Pajjiż: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

INSULIN DEGLUDEC

Disponibbli minn:

NOVO NORDISK LTD., ISRAEL

Kodiċi ATC:

A10AE06

Għamla farmaċewtika:

SOLUTION FOR INJECTION

Kompożizzjoni:

INSULIN DEGLUDEC 100 U/ML

Rotta amministrattiva:

S.C

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

NOVO NORDISK A/S, DENMARK

Żona terapewtika:

INSULIN DEGLUDEC

Indikazzjonijiet terapewtiċi:

Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year.

Data ta 'l-awtorizzazzjoni:

2019-03-31

Fuljett ta 'informazzjoni

Page 1 of 18
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
TREGLUDEC
®
100 UNITS/ML
SOLUTION FOR INJECTION IN PRE-FILLED PEN
ACTIVE INGREDIENT: INSULIN DEGLUDEC 100 UNITS/ML
Inactive ingredients and allergens in this medicine: see section 2
under ‘Important information about
some of this medicine’s ingredients’ and section 6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Tregludec 100 units/ml is used to treat diabetes mellitus in adults,
adolescents, and children aged 1
year and above.
THERAPEUTIC GROUP: diabetes medicines, long-acting insulins and
analogs for injection.
Tregludec 100 units/ml is a long-acting basal insulin called insulin
degludec. Tregludec 100 units/ml
helps your body lower your blood sugar level. It is used for
once-daily dosing. On occasions when
you cannot follow your regular dosing schedule, you can change the
injection time because
Tregludec 100 units/ml has a long-acting blood sugar-lowering effect
(see section 3 for ‘Flexibility in
injection time'). Tregludec 100 units/ml can be used in combination
with meal-related rapid-acting
insulin products.
In type 2 diabetes mellitus, Tregludec 100 units/ml can be combined
with antidiabetic preparations:
tablets or injectables other than insulin.
In type 1 diabetes mellitus, Tregludec 100 units/ml must always be
used in combination with meal-
related rapid-acting insulin products.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:

you are sensitive (allergic) to insulin degludec or any of the other
ingredients in this
medicine (listed in sec

Karatteristiċi tal-prodott

1.
NAME OF THE MEDICINAL PRODUCT
Tregludec
®
100 units/mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled pen contains 300 units of insulin degludec in 3 mL
solution.
1 mL solution contains 100 units insulin degludec* (equivalent to 3.66
mg insulin degludec).
*Produced in
_Saccharomyces cerevisiae_
by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (FlexTouch).
Clear, colourless, neutral solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
from the age of 1 year.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
This medicinal product 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. One (1) unit of
insulin degludec corresponds to 1 international unit of human insulin,
1 unit of insulin glargine
(100 units/mL), or 1 unit of insulin detemir.
In patients with type 2 diabetes mellitus, this medicinal product can
be administered alone or in any
combination with oral antidiabetic medicinal products, GLP-1 receptor
agonists and bolus insulin (see
section 5.1).
In type 1 diabetes mellitus, Tregludec 100 units/mL must be combined
with short-/rapid-acting insulin
to cover mealtime insulin requirements.
Tregludec 100 units/mL 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.
Adjustment of dose may be necessary if patients undertake increased
physical activity, change their
usual diet or during concomitant illness.
The needed dose is dialled in units.
A dose of 1–80 units per injection, in steps of 1 unit, can be
administered.
The dose counter shows the number of units regardless of strength and
NO
dose conversion should be
done when transferring a patient to a new strength.
_Flexibilit