JYNNEOS- vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen injection, suspension

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN (UNII: TU8J357395) (VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN - UNII:TU8J357395)

Tilgængelig fra:

Bavarian Nordic A/S

Indgivelsesvej:

SUBCUTANEOUS

Terapeutiske indikationer:

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

Produkt oversigt:

• 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.

Autorisation status:

Biologic Licensing Application

Produktets egenskaber

JYNNEOS- VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-
REPLICATING ANTIGEN INJECTION, SUSPENSION
BAVARIAN NORDIC A/S
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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