País: Armenia
Idioma: inglés
Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
dulaglutide
Eli Lilly and Company
A10BJ05
dulaglutide
1,5mg/0.5ml
solution for injection
(4) pre-filled glass pen 0.5ml
Prescription
Registered
2018-08-07
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 Leer el documento completo
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 Leer el documento completo