Држава: Сингапур
Језик: Енглески
Извор: HSA (Health Sciences Authority)
Dulaglutide
DKSH SINGAPORE PTE. LTD.
A10BJ05
INJECTION, SOLUTION
Dulaglutide 0.75mg/0.5ml
SUBCUTANEOUS
Prescription Only
Eli Lilly and Company
ACTIVE
2016-03-18
INSTRUCTIONS FOR USE TRULICITY TM 0.75 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN dulaglutide Unfold and lay flat → Read both sides for full instructions ABOUT TRULICITY PRE-FILLED PEN PLEASE READ THESE INSTRUCTIONS FOR USE AND THE PACKAGE INSERT CAREFULLY AND COMPLETELY BEFORE USING YOUR PRE-FILLED PEN. TALK TO YOUR DOCTOR, PHARMACIST OR NURSE ABOUT HOW TO INJECT TRULICITY CORRECTLY. • The pen is a disposable, pre-filled delivery device that is ready to use. Each pen contains one weekly dose of Trulicity (0.75 mg). Each pen delivers one dose only. • TRULICITY IS ADMINISTERED ONCE A WEEK. You may want to mark your calendar to remind you when to inject your next dose. • When you press the green injection button, the pen will automatically insert the needle INTO YOUR SKIN, inject the medicine, and pull back (retract) the needle AFTER THE INJECTION IS COMPLETE. BEFORE YOU GET STARTED REMOVE CHECK INSPECT PREPARE from the refrigerator. Leave the base cap on until you are ready to inject. the label to make sure you have the correct medicine and it has not expired. the pen. Do not use if you notice that the pen is damaged, or the medicine is cloudy, discoloured or has particles in it. by washing your hands. CHOOSE YOUR INJECTION SITE • Your doctor, pharmacist or nurse can help you choose the injection site that is best for you. • You may inject the medicine into your stomach (abdomen) or thigh. • Another person may give you the injection in your upper arm. • Change (rotate) your injection site each week. You may use the same area of your body, but be sure to choose a different injection site in that area. FRONT BACK 1. UNCAP 2. PLACE AND UNLOCK 3. PRESS AND HOLD 1 UNCAP Make sure the pen is LOCKED . • Pull off the grey base cap. DO NOT PUT THE BASE CAP BACK ON – THIS COULD DAMAGE THE NEEDLE. DO NOT TOUCH THE NEEDLE. • When removed, the grey base cap appears as shown and can be discarded 2 PLACE AND UNLOCK • Place the clear base flat and firmly against your skin at the injection site. UNLOCK Прочитајте комплетан документ
Page 1 of 25 EUSPC17JUN2021 TRULICITY™ 0.75 MG OR 1.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN Prescription only. 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. Not all strengths, pack sizes, or presentations 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 Page 2 of 25 _ _ 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 insul Прочитајте комплетан документ