Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN (UNII: TU8J357395) (VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN - UNII:TU8J357395)
Bavarian Nordic A/S
SUBCUTANEOUS
JYNNEOS is a vaccine indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available human data on JYNNEOS administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. The effect of JYNNEOS on embryo-fetal and post-natal development was evaluated in four developmental toxicity studies conducted in female rats and rabbits. In two studies, rats were administered a single human dose of JYNNEOS (0.5 mL) once prior to mating and on one or two occasions during gestation. In the third study, rats were administered a single human dose of JYNNEOS (0.5 mL) on two occasions during gestation. In the fourth study, rabbits were ad
• Package of 10 single-dose vials (Package NDC number: 50632-001-03; Vial NDC number: 50632-001-01) • Package of 20 single-dose vials (Package NDC number: 50632-001-02; Vial NDC number: 50632-001-01) Keep frozen at -25°C to -15°C (-13°F to +5°F). Store in the original package to protect from light. Do not re-freeze a vial once it has been thawed. Once thawed, the vaccine may be kept at +2°C to +8°C (+36°F to +46°F) for 4 weeks. Do not use the vaccine after the expiration date shown on the vial label.
Biologic Licensing Application
JYNNEOS- VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON- REPLICATING ANTIGEN INJECTION, SUSPENSION BAVARIAN NORDIC A/S ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE JYNNEOS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JYNNEOS. JYNNEOS (SMALLPOX AND MONKEYPOX VACCINE, LIVE, NON-REPLICATING) SUSPENSION FOR SUBCUTANEOUS INJECTION INITIAL U.S. APPROVAL: 2019 RECENT MAJOR CHANGES Dosage and Administration (2.2) 03/2023 Warnings and Precautions (5.2) 09/2023 INDICATIONS AND USAGE JYNNEOS is a vaccine indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. (1) DOSAGE AND ADMINISTRATION FOR SUBCUTANEOUS INJECTION ONLY. Administer two doses (0.5 mL each) 4 weeks apart. (2.1, 2.2) DOSAGE FORMS AND STRENGTHS Suspension for injection. Each dose (0.5 mL) is supplied in a single-dose vial. (3) ADVERSE REACTIONS • • • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAVARIAN NORDIC AT TOLL-FREE PHONE 1- 800-675-9596 OR VAERS AT 1-800-822-7967 OR WWW.VAERS.HHS.GOV. SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 9/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Dose and Schedule 2.2 Preparation and Administration 3 DOSAGE FORMS AND STRENGTHS 5 WARNINGS AND PRECAUTIONS 5.1 Severe Allergic Reactions In smallpox vaccine-naïve healthy adults, the most common (> 10%) solicited injection site reactions were pain (84.9%), redness (60.8%), swelling (51.6%), induration (45.4%), and itching (43.1%); the most common solicited systemic adverse reactions were muscle pain (42.8%), headache (34.8%), fatigue (30.4%), nausea (17.3%) and chills (10.4%). (6.1) In healthy adults previously vaccinated with a smallpox vaccine, the most common (> 10%) solicited injection site reactions were redness (80.9%), pain (79.5%), induration (70.4%), swelling (67.2%), and itching (32.0%); the most comm Lue koko asiakirja