Fluzone package insert fda
[PDF File]Influenza Vaccine STN BL 125254 Package insert
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Package insert Influenza Vaccine STN BL 125254 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE AFLURIA® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A …
Sanofi Pasteur 26 December 2017 v 0.2 450/477 Fluzone ...
22 Fluzone Quadrivalent Southern Hemisphere is supplied in 3 presentations: Sanofi Pasteur 26 December 2017 v 0.2 450/477 Fluzone ® Quadrivalent Southern Hemisphere LE7138, 7141
[PDF File]HIGHLIGHTS OF PRESCRIBING INFORMATION maintenance …
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demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of RETACRIT has been demonstrated for the condition(s) of use
[PDF File]Page 1 of 4 Influenza Virus Vaccine
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Fluzone vaccine is a sterile suspension for intramuscular injection. Each 0.25 mL dose of Fluzone vaccine contains 7.5 micrograms (mcg) of influenza virus hemagglutinin (HA) and each 0.5 mL dose contains 15 mcg HA from each of the following 3 viruses: A/Brisbane/59/2007, IVR-148 (H1N1), A/Uruguay/716/2007,
Sanofi Pasteur 450/477 Fluzone Quadrivalent Southern ...
Fluzone Quadrivalent Southern Hemisphere is a suspension for injection. Fluzone Quadrivalent Southern Hemisphere is supplied in 3 presentations: 1) Prefilled single-dose syringe (pink syringe plunger rod), 0.25 mL, for persons 6 months
Page 1 of 6 Sanofi Pasteur Quadrivalent HIGHLIGHTS OF ...
Fluzone Quadrivalent should not be combined through reconstitution or mixed with any other vaccine. 3 DOSAGE FORMS AND STRENGTHS Fluzone Quadrivalent is a suspension for injection. Fluzone Quadrivalent is supplied in 4 presentations: 1) Prefilled single-dose syringe (pink syringe plunger rod), 0.25 mL, for persons 6 months through 35 months of age.
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Fluzone Quadrivalent is a vaccineindicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Sanofi Pasteur 07Jan2019v0.2 372 Fluzone High-Dose LE7413 ...
Dose or Fluzone (2011-2012 and 2012-2013 formulations). The study compared the efficacy and safety of Fluzone High-Dose to those of Fluzone. The safety analysis set included 15,992 Fluzone High-Dose recipients and 15,991 Fluzone recipients. Within the study surveillance period (approximately 6 to 8 months post-vaccination), 1323
[PDF File]Vaccine Excipient Summary-Excipients Included in U.S ...
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PI, which can be found on the FDA’s website (see below) contains a description of that vaccine’s manufacturing process, including the amount and purpose of each substance. In most PIs, this information is found in Section 11: “Description.” All information was extracted from manufacturers’ package inserts.
[PDF File]HIGHLIGHTS OF PRESCRIBING INFORMATION ...
https://info.5y1.org/fluzone-package-insert-fda_1_eb9e51.html
FDA-approved patient labeling. Tablets: 20 mg and 40 mg (3) Revised: 10/2018 . FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS . 5.1 Bacterial Infections . 6 ADVERSE REACTIONS . 6.1 Clinical Trials Experience . 7 DRUG …
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