Evusheld

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Tixagevimab 100 mg/mL;  ; Cilgavimab 100 mg/mL;  

Предлага се от:

AstraZeneca Limited

дозиране:

100 mg/mL

Лекарствена форма:

Solution for injection

Композиция:

Active: Tixagevimab 100 mg/mL   Excipient: Histidine Histidine hydrochloride monohydrate Polysorbate 80 Sucrose Water for injection Active: Cilgavimab 100 mg/mL   Excipient: Histidine Histidine hydrochloride monohydrate Polysorbate 80 Sucrose Water for injection

Вид предписание :

Prescription

Терапевтични показания:

Evusheld is indicated for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg, - Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination or - For whom vaccination with any approved COVID-19 vaccine is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).

Каталог на резюме:

Package - Contents - Shelf Life: Combination pack, 1x single dose vial of tixagevimab + 1x single dose vial of cilgavimab - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 hours opened stored at 2° to 8°C (Refrigerate, do not freeze). (or at or below 25?C), not to exceed a cumulative in-use time of 4 hours - Vial, glass, Single dose of formulated cilgavimab (150 mg) - 1.5 mL - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Single dose of formulated tixagevimab (150 mg) - 1.5 mL - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Дата Оторизация:

2022-04-26

Листовка

Evusheld™ CMI 200323
1(3)
E
VUSHELD
™
TIXAGEVIMAB 150 MG AND CILGAVIMAB 150 MG, SOLUTION FOR INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
EVUSHELD. It does not contain all the
information that is known about EVUSHELD.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking EVUSHELD against the
benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet, you may need to read it again.
WHAT EVUSHELD IS USED FOR
EVUSHELD contains the active ingredients tixagevimab and cilgavimab.
Tixagevimab and cilgavimab are types of protein called ‘monoclonal
antibodies’.
Tixagevimab and cilgavimab (EVUSHELD) work specifically against the
SARS-CoV-2 virus preventing it from entering
your cells. This can help prevent you from getting COVID-19 illness.
COVID-19 is an illness which can affect your lungs, airways and other
organs. COVID-19 illnesses can be very mild
(sometimes with no symptoms), however in some cases symptoms can be
severe and can result in hospitalisation
or even death.
EVUSHELD is used to help prevent adults and adolescents (aged 12 years
and older weighing at least 40 kg), who
have not been recently in contact with someone who has COVID-19, from
getting COVID-19 illness when they:
•
have an illness or take medicines making them unlikely to respond to
or be protected by vaccination against
COVID-19
•
or are not recommended to have a vaccine due to a history of severe
allergies to a COVID-19 vaccine or its
components.
EVUSHELD is not a substitute for vaccination in individuals for whom
COVID-19 vaccination is recommended.
This medicine is only available with a doctor's prescription.
BEFORE YOU USE EVUSHELD
_WHEN YOU MUST NOT USE IT _
DO NOT USE EVUSHELD IF: you are allergic to tixagevimab, cilgavimab or
any of the ingredients listed

Данни за продукта

E
VUSHELD
Data Sheet 200323
Copyright
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
E
VUSHELD
; 150 mg + 150 mg; solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each carton of E
VUSHELD
contains two vials:
•
150 mg of tixagevimab in 1.5 mL (100 mg/mL).
•
150 mg of cilgavimab in 1.5 mL (100 mg/mL).
Tixagevimab and cilgavimab are human monoclonal antibodies 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.
Clear to opalescent, colourless to slightly yellow, pH 6.0 solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
E
VUSHELD
has provisional consent (see section 5.1) for the following indication
below:
E
VUSHELD
is indicated for the pre-exposure prophylaxis of COVID-19 in adults
and adolescents
aged 12 years and older weighing at least 40 kg,
-
Who have moderate to severe immune compromise due to a medical
condition or receipt
of immunosuppressive medications or treatments that make it likely
that they will not
mount an adequate immune response to COVID
‐
19 vaccination, OR
-
For whom vaccination with any approved COVID
‐
19 vaccine is not recommended due to
a history of severe adverse reaction (e.g., severe allergic reaction)
to a COVID
‐
19
vaccine(s) and/or COVID
‐
19 vaccine component(s).
See sections 4.2, 5.1 and 5.2.
4.2
DOSE AND METHOD OF ADMINISTRATION
Administration should be under conditions where management of severe
hypersensitivity
reactions, such as anaphylaxis, is possible. Individuals should be
observed after administration
according to local medical practice
E
VUSHELD
Data Sheet 200323
Copyright
2
DOSE
The recommended dose in adults and adolescents aged 12 years and older
weighing at least
40 kg is 150 mg of tixagevimab and 150 mg of cilgavimab, administered
as two separate
sequential intramuscular injections.
There are no safety and efficacy data available on repeat dosing.
SPECIAL PATIENT POPULATIONS
Elderly
No dose adjustment is required (s