Trulicity solution for injection

Country: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

dulaglutide

Disponibbli minn:

Eli Lilly and Company

Kodiċi ATC:

A10BJ05

INN (Isem Internazzjonali):

dulaglutide

Dożaġġ:

1,5mg/0.5ml

Għamla farmaċewtika:

solution for injection

Unitajiet fil-pakkett:

(4) pre-filled glass pen 0.5ml

Tip ta 'preskrizzjoni:

Prescription

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2018-08-07

Fuljett ta 'informazzjoni

TRULICITY 0.75 MG SOLUTION FOR
INJECTION IN PRE-FILLED PEN
TRULICITY 1.5 MG SOLUTION FOR
INJECTION IN PRE-FILLED PEN
TRULICITY 0.75 MG SOLUTION FOR
INJECTION IN PRE-FILLED PEN
TRULICITY 1.5 MG SOLUTION FOR
INJECTION IN PRE-FILLED PEN
NL007DAEN00
NL007DAEN00
EUSPC21OCT2019
TRULICITY
™
0.75 MG OR 1.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
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
Each pre‑filled pen contains 0.75 mg of dulaglutide* in 0.5 ml
solution.
Trulicity 1.5 mg solution for injection
Each pre‑filled pen contains 1.5 mg of dulaglutide* in 0.5 ml
solution.
Not all strengths may be marketed.
*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.
For potentially vulnerable populations 0.75 mg once weekly can be
considered as a starting dose.
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

Karatteristiċi tal-prodott

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Each pre-filled pen contains 0.75 mg of dulaglutide* in 0.5 ml
solution.
Trulicity 1.5 mg solution for injection
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.
For potentially vulnerable populations 0.75 mg once weekly can be
considered as a starting dose.
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).
3
The use of Trulicity does not require blood glu