EMGALITY galcanezumab 120mg/mL prefilled syringe

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

galcanezumab, Quantity: 120 mg/mL

Tersedia dari:

Eli Lilly Australia Pty Ltd

Bentuk farmasi:

Injection, solution

Komposisi:

Excipient Ingredients: histidine; water for injections; polysorbate 80; sodium chloride; histidine hydrochloride monohydrate

Rute administrasi :

Subcutaneous

Unit dalam paket:

1, 2, 3

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

EMGALITY is indicated for the prophylaxis of migraine in adults.

Ringkasan produk:

Visual Identification: The solution is clear and colourless to slightly yellow; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

2019-05-28

Selebaran informasi

EMGALITY
Page 1 of 4

This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can
help by reporting any side effects you may get. You can report side
effects to your doctor, or directly at
www.tga.gov.au/reporting-problems.
EMGALITY
®
_PREFILLED PEN (AUTOINJECTOR) AND PREFILLED SYRINGE _
_Galcanezumab _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EMGALITY. It does
not contain all the available
information. It should not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking EMGALITY
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT EMGALITY IS
USED FOR
EMGALITY is used to prevent
migraine in adult patients.
Migraine is a disease affecting the
nervous system where patients suffer
with repeated headaches, often only
affecting one side of the head. The
headaches are commonly associated
with feeling nauseous, or actually
vomiting, and patients can also be
very sensitive to light and sound.
The active ingredient in EMGALITY
is galcanezumab. Galcanezumab
belongs to a group of preventative
medicines that stop the activity of a
naturally occurring substance in the
body called calcitonin-gene-related
peptide (CGRP). Increased levels of
CGRP have been associated with
migraine.
EMGALITY has been shown to
improve quality of life by
significantly reducing the frequency
of migraine headache, with an onset
of effect as early as one week after
starting treatment.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY EMGALITY
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
EMGALITY is available only with a
doctor's prescription.
.EMGALITY could have a minor
effect on your ability to drive and use
machines. Some patients hav

Karakteristik produk

AUSTRALIAN PRODUCT INFORMATION
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to
report any suspected adverse events at
www.tga.gov.au/reporting-problems.
EMGALITY® (GALCANEZUMAB) PREFILLED PEN AND PREFILLED
SYRINGE
1.
NAME OF THE MEDICINE
Galcanezumab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prefilled pen (autoinjector) or prefilled syringe contains 120 mg
of galcanezumab in
1 mL.
EMGALITY solution is sterile and preservative-free.
Galcanezumab is a humanised monoclonal antibody (IgG4) produced in
Chinese Hamster
Ovary (CHO) cells by recombinant DNA technology. It is composed of two
identical
immunoglobulin kappa light chains and two identical immunoglobulin
gamma heavy
chains (Molecular Weight = 144,084 Da non-glycosylated, disulfide
linked).
EMGALITY is administered as a subcutaneous injection.
EXCIPIENT WITH KNOWN EFFECT
Each 1mL of product contains approximately 3.5 mg sodium.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen (autoinjector).
Solution for injection in pre-filled syringe.
The solution is clear and colourless to slightly yellow.
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2
vA1.0_29May2019
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EMGALITY is indicated for the prophylaxis of migraine in adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Emgality should be initiated by physicians experienced in the
diagnosis and treatment of
migraine.
The recommended dose is 120 mg galcanezumab injected subcutaneously
once monthly,
with a 240 mg loading dose as the initial dose.
Treatment response should be evaluated by the prescriber after 8-12
weeks as
recommended by the current Australian treatment guideline. 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.
Instruct patients to inject a missed dose