Land: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Tixagevimab 100 mg/mL; ; Cilgavimab 100 mg/mL;
AstraZeneca Limited
100 mg/mL
Solution for injection
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
Prescription
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).
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
2022-04-26
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 Lestu allt skjalið
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 Lestu allt skjalið