Ajovy
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
20-11-2023
Karatteristiċi tal-prodott
(SPC)
20-11-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
17-04-2019
Ingredjent attiv:
fremanezumab
Disponibbli minn:
Teva GmbH
Kodiċi ATC:
N02CD03
INN (Isem Internazzjonali):
fremanezumab
Grupp terapewtiku:
Calcitonin gene-related peptide (CGRP) antagonists
Żona terapewtika:
Migraine Disorders
Indikazzjonijiet terapewtiċi:
Ajovy is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
Sommarju tal-prodott:
Revision: 10
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2019-03-28
Fuljett ta 'informazzjoni
26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AJOVY 225 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
fremanezumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What AJOVY is and what it is used for
2.
What you need to know before you use AJOVY
3.
How to use AJOVY
4.
Possible side effects
5.
How to store AJOVY
6.
Contents of the pack and other information
1.
WHAT AJOVY IS AND WHAT IT IS USED FOR
WHAT AJOVY IS
AJOVY is a medicine containing the active substance fremanezumab, a
monoclonal antibody, a type
of protein that recognises and attaches to a specific target in the
body.
HOW AJOVY WORKS
A substance in the body called calcitonin gene-related peptide (CGRP)
plays an important role in
migraine. Fremanezumab attaches to CGRP and prevents it from working.
This reduction in CGRP's
activity reduces migraine attacks.
WHAT AJOVY IS USED FOR
AJOVY is used to prevent migraine in adults who have at least 4
migraine days per month.
WHAT ARE THE BENEFITS OF USING AJOVY
AJOVY reduces the frequency of migraine attacks and days with
headache. This medicine also
decreases the disability associated with migraine and it reduces the
need for medicines used to treat
migraine attacks.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AJOVY
_ _
DO NOT USE AJOVY
Do not use this medicine if you are allergic to fremanezumab or any of
the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse immediately if you get any
signs
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
AJOVY 225 mg solution for injection in pre-filled syringe
AJOVY 225 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringe
One pre-filled syringe contains 225 mg fremanezumab.
Pre-filled pen
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 prophylaxis of migraine in adults who have at
least 4 migraine days per
month.
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
continue treatment is recommended regularly thereafter.
3
_Missed dose _
If a fremanezumab injection is missed on the planned date, dosing
should resume as soon as possible
on the indicated dose and regimen. A double dose must not be
administered to make up for a missed
dose.
Special populations
_Elderly _
There is limited data available on the use of fremanezumab in patie
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