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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

PFIZER-BIONTECH COVID-19 VACCINE BNT162b2 Suspension for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Pfizer Manufacturing Belgium NV

Λέξεις κλειδιά

59267-1000

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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1. Indications and Usage

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory ...

2. Dosage and Administration

For intramuscular injection only. 2.1 Preparation for Administration <u>Prior to Dilution:</u> The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a frozen suspension that does not contain ...

3. Dosage Forms and Strengths

Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. After preparation, a single dose is 0.3 mL.

4. Contraindications

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine <em>[see ...

5. Warnings and Precautions

5.1 Management of Acute Allergic Reactions Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following ...

6. Adverse Reactions

Overall Safety Summary <b>It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

7. Drug Interactions

There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

8.1. Pregnancy

Risk Summary 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 ...

8.2. Lactation

Risk Summary Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

8.4. Pediatric Use

Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine in adolescents 16 and 17 years of age is based on extrapolation of safety and effectiveness from adults 18 years of age and older. Emergency ...

8.5. Geriatric Use

Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy <em>[see Overall Safety Summary ...

11. Description

The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form ...

12.1. Mechanism of Action

The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits ...

14. Clinical Studies

Clinical Trial Results and Supporting data for EUA Efficacy in Participants 16 Years of Age and Older Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, ...

16.1. How Supplied

Pfizer-BioNTech COVID-19 Vaccine Suspension for Intramuscular Injection, Multiple Dose Vials are supplied in a carton containing 25 multiple dose vials (NDC 59267-1000-3) or 195 multiple dose vials (NDC ...

16.2. Storage and Handling

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Do not refreeze thawed vials. Frozen Vials Prior to Use Cartons of Pfizer-BioNTech COVID-19 ...

17. Patient Counseling Information

Advise the recipient or caregiver to read the Fact Sheet for Recipients and Caregivers. The vaccination provider must include vaccination information in the state/local jurisdictions Immunization Information ...