Emgality

Страна: Нова Зеландія

мова: англійська

Джерело: Medsafe (Medicines Safety Authority)

Активний інгредієнт:

Galcanezumab 120 mg/mL

Доступна з:

Eli Lilly and Company (NZ) Limited

Дозування:

120 mg/mL

Фармацевтична форма:

Solution for injection

Склад:

Active: Galcanezumab 120 mg/mL Excipient: Histidine Histidine hydrochloride monohydrate Polysorbate 80 Sodium chloride Water for injection

Тип рецепту:

Prescription

Терапевтичні свідчення:

EMGALITY is indicated for the prophylaxis of migraine in adults

Огляд продуктів:

Package - Contents - Shelf Life: Syringe, glass, pre-fitted into a syringe injector device (1 mL fill) - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 7 days not refrigerated stored at or below 30°C protect from light. do not freeze, no return to refrigeration - Syringe, glass, pre-fitted into a syringe injector device (1 mL fill) - 2 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 7 days not refrigerated stored at or below 30°C protect from light. no retrun to refrigeration - Syringe, glass, pre-fitted into a syringe injector device (1 mL fill) - 3 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 7 days not refrigerated stored at or below 30°C protect from light. do not freeze, no return to refrigeration

Дата Авторизація:

2019-09-06

інформаційний буклет

EMGALITY
Page 1 of 4
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 have had
vertigo whilst using EMGALITY.
EMGALITY has not been studied in
patients under 18 years of age.
BEFORE YOU TAKE
EMGALITY
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE EMGALITY IF YOU
HAVE AN ALLERGY TO:
•
Galcanezumab
•
Any of the ingredients listed at
the end of

Характеристики продукта

NEW ZEALAND DATA SHEET
VA1.0_03Sep20
Page 1 of 15
1.
PRODUCT NAME
EMGALITY® 120mg/mL prefilled pen
EMGALITY® 120mg/mL prefilled syringe
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.
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.
VA1.0_03Sep20
Page 2 of 15
The recommended dose is 120 mg galcanezumab injected subcutaneously
once monthly,
with a 240 mg loading dose as the initial dose.
Treatment response for galcanezumab should be evaluated by the
prescriber after 8-12
weeks as recommended by the current American Headache Society
Consensus
Statement
1
. 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 as soon as possible.
Thereafter, resume monthly
dosing.
METHOD OF ADMINISTRATION
EMGALITY is for subcutaneous administration.
A patient may self-inject EMGALITY by following the instructions for
use.
Site