FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE ...
justifying the authorization of the emergency use of REGEN-COV under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Treatment This EUA is for the use of the unapproved product, REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab)
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HIGHLIGHTS OF PRESCRIBING INFORMATION immune …
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www.regeneron.com5% Dextrose Injection, USP to a final concentration between 1 mg/mL to 20 mg/mL. • Mix diluted solution by gentle inversion. Do not shake. • Discard any unused medicinal product or waste material. Storage of Infusion Solution • Store at room temperature up to 25°C (77°F) for no more than 8 hours from the time
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www.regeneron.comCompassionate Use Policy In the USA, this type of compassionate use program is also known as an Expanded Access Program (EAP) and is intended for patients with serious or life-threatening conditions who do not have any viable or available treatment options and are unable to participate in ongoing clinical trials.
DUPIXENT (DU-pix-ent) (dupilumab) injection, Single-Dose ...
www.regeneron.comB. Choose and prepare your injection site B1. Wash your hands well with soap and water B2. Choose an injection site • Thigh • Stomach except for the 2 inches (5 cm) around your belly button (navel). • A caregiver can also inject in the outer area of the upper arm. • Chooseadif ferent site for each injection. B3. Prepare the injection ...
FACT SHEET FOR PATIENTS, PARENTS AND CAREGIVERS …
www.regeneron.comREGEN-COV to treat people with COVID-19 or to prevent COVID-19 in people who are at high risk of being exposed to someone who is infected with SARS-CoV-2. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19. The FDA has authorized the emergency use of . REGEN-COV . for the treatment of COVID-19
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HIGHLIGHTS OF PRESCRIBING INFORMATION The …
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