AJOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 225 MG1.5ML

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Fremanezumab

Disponível em:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Código ATC:

N02CD03

Forma farmacêutica:

INJECTION, SOLUTION

Composição:

Fremanezumab 225 mg/1.5ml

Via de administração:

SUBCUTANEOUS

Tipo de prescrição:

Prescription Only

Fabricado por:

Vetter Pharma-Fertigung GmbH & Co. KG

Status de autorização:

ACTIVE

Data de autorização:

2021-10-04

Folheto informativo - Bula

90°
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BEFORE YOU USE THE AJOVY PRE-FILLED PEN, READ AND CAREFULLY FOLLOW
THE STEP-BY-STEP INSTRUCTIONS.
IMPORTANT INFORMATION:
•
TheAJOVYpre-filledpenisforsingleuseonly.
•
EachAJOVYpre-filledpencontains225mgoffremanezumab.
Dependingonyourdoseyouwillneedtouse1pre-filledpenor3pre-filledpens.
•
AJOVYisinjectedunderyourskin(subcutaneousinjection).Youshouldnotinject
yourselfuntilyouhavebeentrainedbyyourdoctorornurse.
•
CarefullyreadtheAJOVYpackageleaflettolearnmoreaboutyourmedicine.
•
DO NOTshakethepre-filledpen.
•
PUT THE CARTON BACK IN THE REFRIGERATOR
IMMEDIATELY,ifyouhaveanyunused
pre-filledpensinthecarton.
AJOVY PRE-FILLED PEN (BEFORE USE)
•
Theblueplungermovesdowntheviewing
windowduringtheinjection.Theblue
plungerfillsthewindowwhentheinjection
iscomplete.(Note:Whentheblueplunger
hasfilledtheviewingwindowyouwillstill
beabletoseethegreystopper.)
•
WheninjectingAJOVY,holdthepre-filled
pensothatyourhanddoesnotcoverthe
viewingwindow.
AJOVY PRE-FILLED PEN (AFTER USE)
STEP 1: GETTING READY FOR AN INJECTION
A) GATHER THE FOLLOWING SUPPLIES FOR YOUR INJECTION:
−
1or3AJOVYpre-filledpenstoenable1or3injectionsdependingonyourdose
−
1alcoholswabperinjection
−
1gauzepadorcottonballperinjection
−
1sharpsdisposalorpuncture-resistantcontainer
B) PLACE THE SUPPLIES YOU HAVE GATHERED ON A CLEAN, FLAT SURFACE.
C) WAIT FOR 30 MINUTES TO LET AJOVY REACH ROOM TEMPERATURE (<30°C) TO
REDUCE DISCOMFORT DURING
INJECTION.
−
DO NOTleavethepre-filledpenindirectsunlight.
−
DO
NOTwarmupthepre-filledpenusingamicrowaveoranyotherheatsource.
D) WASH YOUR HANDS WITH SOAP AND WATER AND DRY WELL WITH A CLEAN
TOWEL.
E) INSPECT YOUR AJOVY PRE-FILLED PEN.
−
Checkthepenlabel.MakesurethenameAJOVYappearsonthelabel.
−
Checkthatthemedicineinthepenviewingwindowlooksclearandiscolourlesstoslightlyyellow.
−

Características técnicas

PAGE 1 of
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33098_s1
3-8-22
Submission
SMPC
Tiffany
P: Fremanezumab (Ajovy),
PFP, 225mg/1.5ml, PI, Teva
SINGAPORE (SG)
National
AM
t
This medicinal product is subject to additional monitoring. This will
allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse reactions. See section 4.8 for how to report adverse
reactions.
1. NAME OF THE MEDICINAL PRODUCT
AJOVY solution for injection in pre-filled syringe 225 mg/1.5ml
AJOVY solution for injection in pre-filled pen 225 mg/1.5ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe contains 225 mg fremanezumab.
One pre-filled pen contains 225 mg fremanezumab.
Fremanezumab is a humanised monoclonal antibody produced in Chinese
Hamster
Ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection (injection)
Clear to opalescent, colourless to slightly yellow solution with a pH
of 5.5 and an
osmolality of 300-450 mOsm/kg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AJOVY is indicated for the preventive treatment of migraine in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated by a physician experienced in the
diagnosis and
treatment of migraine.
Posology
Two dosing options are available:
•
225 mg once monthly (monthly dosing) or
•
675 mg every three months (quarterly dosing)
When switching dosing regimens, the first dose of the new regimen
should be
administered on the next scheduled dosing date of the prior regimen.
When initiating treatment with fremanezumab, concomitant migraine
preventive treatment
may be continued if considered necessary by the prescriber (see
section 5.1).
The treatment benefit should be assessed within 3 months after
initiation of treatment.
Any further decision to continue treatment should be taken on an
individual patient basis.
Evaluation of the need to contin