TRULICITY 1.5 MG

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

DULAGLUTIDE

Mevcut itibaren:

ELI LILLY ISRAEL LTD, ISRAEL

ATC kodu:

A10BX14

Farmasötik formu:

SOLUTION FOR INJECTION

Kompozisyon:

DULAGLUTIDE 1.5 MG / 0.5 ML

Uygulama yolu:

S.C

Reçete türü:

Required

Tarafından üretildi:

ELI LILLY & COMPANY LTD., USA

Terapötik alanı:

DULAGLUTIDE

Terapötik endikasyonlar:

Type 2 Diabetes MellitusTrulicity is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications• in addition to other medicinal products for the treatment of diabetes.

Yetkilendirme tarihi:

2020-08-31

Bilgilendirme broşürü

I TRULPN S 13
Page 1 of 6
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a
physician’s
prescription only
TRULICITY 0.75 MG,
SOLUTION FOR INJECTION IN
A PRE-FILLED PEN
TRULICITY 1.5 MG,
SOLUTION FOR INJECTION IN
A PRE-FILLED PEN
ACTIVE INGREDIENT AND ITS CONCENTRATION:
Each pre-filled pen contains:
0.75 mg dulaglutide in 0.5 ml solution
ACTIVE INGREDIENT AND ITS CONCENTRATION:
Each pre-filled pen contains:
1.5 mg dulaglutide in 0.5 ml solution
INACTIVE INGREDIENTS AND ALLERGENS: See section 2
“
Important information about some of the
ingredients of this medicine
” and section 6
“
Additional information
”
.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions, ask
your doctor or
pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others.
It may harm them, even if it seems to you that their illness is the
same as yours.
1. WHAT IS THIS MEDICINE USED FOR?
TRULICITY is indicated for the treatment of adults with insufficiently
controlled type 2 diabetes
mellitus as an adjunct to diet and exercise:
•
as monotherapy when metformin is considered inappropriate
•
in addition to other medicinal products for the treatment of diabetes
THERAPEUTIC GROUP: Drugs used in diabetes, blood glucose lowering
drugs, excluding insulins.
TRULICITY contains an active substance called dulaglutide and is used
to lower blood sugar level
(glucose) in adults with type 2 diabetes mellitus and can help prevent
heart disease.
Type 2 diabetes is a condition in which your body does not make enough
insulin, and the insulin
that your body produces does not work as well as it should. When this
happens, sugar (glucose)
builds up in the blood.
It is important to continue to follow the advice on diet and exercise
given to you by your doctor,
nurse or pharmacist.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS ME

Ürün özellikleri

X TRULPN S 14
Page 1 of 25
1.
NAME OF THE MEDICINAL PRODUCT
Trulicity 0.75 mg solution for injection in pre-filled pen
Trulicity 1.5 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trulicity 0.75 mg solution for injection in pre-filled pen
Each pre-filled pen contains 0.75 mg of dulaglutide* in 0.5 ml
solution.
Trulicity 1.5 mg solution for injection in pre-filled pen
Each pre-filled pen contains 1.5 mg of dulaglutide* in 0.5 ml
solution.
*Produced in CHO cells by recombinant DNA technology
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Type 2 Diabetes Mellitus
Trulicity is indicated for the treatment of adults with insufficiently
controlled type 2 diabetes mellitus as
an adjunct to diet and exercise
_ _

as
monotherapy
when
metformin
is
considered
inappropriate
due
to
intolerance
or
contraindications.

in addition to other medicinal products for the treatment of diabetes.
For study results with respect to combinations, effects on glycaemic
control and cardiovascular events, and
the populations studied, see sections 4.4, 4.5 and 5.1.
4.2
Posology and method of administration
_ _
Posology
_Monotherapy _
The recommended dose is 0.75 mg once weekly.
_Add-on therapy_
The recommended dose is 1.5 mg once weekly.
X TRULPN S 14
Page 2 of 25
_Combination therapy _
When Trulicity is added to existing metformin and/or pioglitazone
therapy, the current dose of metformin
and/or pioglitazone can be continued. When Trulicity is added to
existing metformin and/or sodium-
glucose co-transporter 2 inhibitor (SGLT2i) therapy, the current dose
of metformin and/or SGLT2i can be
continued. When it is added to existing therapy of a sulphonylurea or
insulin, a reduction in the dose of
sulphonylurea or insulin may be considered to reduce the risk of
hypoglycaemia (see sections 4.4 and
4.8).
The use of Trulicity does not require blood glucose self-monitoring.
Bloo