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Vaccine Package Inserts
[Links to Sources]
Human Vaccines - Here:
Animal Vaccines (Click)
Suggestion:
If you do not see the vaccine of interest in our "Mini Index", then use your browser Edit/Find to locate on this page the inserts of interest.

M I N I   -  I N D E X

Alphabetical-List  |   FluVaccines  |   TB-VAX/Tubersol  |   5-in-one/6-in-one(hexa)  |   Animal Vaccines
GlaxoSmithKline/GSK  |   Merck  |   Misc   |   Military  |   RotaVirus/ProQuad-MMRV/VAQTA-HepA  |   SwineFluVaccines  |   Vaccine_Information_Sheets_(VIS)  |   VitaminK



Links to CDC lists of Vaccine Ingredients
Includes some archived material for research
http://vaclib.org/basic/vacingredient.htm#tables

Vaccine Ingredients and Manufacturer Information (ProCon.org)
http://vaccines.procon.org/view.resource.php?resourceID=005206

For more Material Safety Data Sheets See: Animal Vaccines

Alphabetical list of Vaccines
Their page may also be sorted by Antigen or by Manufacturer
A good One Stop page for links to current vaccine package inserts is this John Hopkins Bloomberg School of Public Health web site:
http://www.vaccinesafety.edu/package_inserts.htm


Manufacturers: sanofi pasteur, CLS Limited, Novartis, Bayer, Emergent BioSolutions, GlaxoSmithKline, Merck, Aventis Pasteur, MedImmune, Intercell Biomedical, NABI, Chiron, Mass Biol Labs, Berna/

Package Inserts
Vaccines, Blood & Biologics
http://www.fda.gov/BiologicsBloodVaccines/vaccines/ApprovedProducts/ucm093830.htm


MilVax
Military Vaccine Agency
http://www.vaccines.mil/Package_Insert
Includes childhood vaccines


Package Inserts maintained by Immunization Action Coalition [several manufacturers]
Merck package inserts

Listed here are all the products currently distributed by sanofi pasteur, sorted by disease category. Click on the PDF graphic to download the package insert.
http://www.vaccineshoppe.com/index.cfm?fa=anon.piexpress

L I N K to many package inserts - US Licensed Vaccines and Immunoglobulins:
http://www.vaccinesafety.edu/package_inserts.htm
Institute for Vaccine Safety: Package Insert INDEX page for following:

Vaccine "Information" Statement
IMPORTANT: By Federal law, all vaccine providers must give patients, or their parents or legal representatives, the appropriate Vaccine Information Statement (VIS) whenever a vaccination is given.

Quote from CDC
"What is a Vaccine Information Statement?
A Vaccine Information Statement (VIS) is a one-page (two-sided) information sheet, produced by CDC. VISs inform vaccine recipients — or their parents or legal representatives — about the benefits and risks of a vaccine. The law requires that VISs given out whenever certain vaccinations are given."


[Note: Please question the rather brief VIS "information" statements for accuracy regarding alleged benefits and risks. The package inserts will give a fuller picture of contraindications and reported side effects.]


GlaxoXmithKline Vaccines
See links under Alphabetical list of Vaccines above


FluMist package inserts:
PDR Drug information for Flumist Vaccine http://www.drugs.com/PDR/Flumist_Vaccine.html

http://www.medimmune.com/pdf/products/flumist_pi.pdf


Other Flu Vaccine Package Inserts:
Name - Manufacturer
Fluarix - GlaxoSmithKline | http://us.gsk.com/products/assets/us_fluarix.pdf

Fluzone - sanofi pasteur | http://www.vaccineshoppe.com/index.cfm?fa=anon.piexpress

FluMist - MedImmune | http://www.medimmune.com/pdf/products/flumist_pi.pdf



The vaccines.mil site includes package inserts for common vaccines including those for children, as well as links to smallpox vaccine and travel or military service related vaccines.

See the next section (below) for links to RotaVirus, MMRV and HepA vaccine Package Insert pages as well as information pages.
Vaccine Info: Vaccines
AFLURIA® (Influenza Virus Vaccine)
COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]
GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]
M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live)
PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]
PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)
ProQuad® (Measles, Mumps, Rubella, and Varicella Virus Vaccine Live)
RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)]
RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)
Tetanus and Diphtheria Toxoids Adsorbed
VAQTA® (Hepatitis A Vaccine, Inactivated)
VARIVAX® (Varicella Virus Vaccine Live)
ZOSTAVAX® (Zoster Vaccine Live)
On Merck's web page, Click on disease of interest.
On each vaccine, click on prescribing information for the pdf package insert for that vaccine.
Package Inserts
Merck: Pneumococcal/Rotavirus/MMRV/HepA/Varicella
Pneumovax 23® Package Insert
http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdf

RotaTeq®
[Rotavirus Vaccine, Live, Oral, Pentavalent]
RotaTeq PACKAGE INSERT:http://www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_pi.pdf

ProQuad® (MMRV)
ProQuad (MMRV) PACKAGE INSERT: http://www.merck.com/product/usa/pi_circulars/p/proquad/proquad_pi.pdf

VAQTA®/HepA
http://www.merck.com/product/usa/pi_circulars/v/vaqta/vaqta_pi.pdf

ZOSTAVAX® (live Varicella/Chicken Pox)
http://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_pi.pdf

Swine Flu Vaccines
2012-2013
Fluvirin®. 2012-2013 FORMULA


2009-2010 [For Reference]
CSL Biotherapies INC.
CSL Package insert for Influenza A (H1N1) 2009 Monovalent Vaccine
Note: the 2009 Monovalent Vaccine is an inactivated influenza virus vaccine manufactured by the same process as AFLURIA. There have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA.

MedImmune LLC
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal manufactured by MedImmune LLC
package insert and related documents:  ||   Package Insert for Medimmune:

Novartis
Novartis’ Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (FLUVIRIN) are manufactured by the same process.
package insert and related documents:
Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited) Package Insert:

Sanofi Pasteur
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine
package insert and related documents:
Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur, Inc.) package insert:

Vitamin K
Merck & Co., Inc
AquaMEPHYTON® (Phytonadione)
Aqueous Colloidal Solution of Vitamin K

Not a vaccine, but Vitamin K is often given at birth.

There are warnings about Intravenous and Intramuscular administration including severe reactions including death in situations where subcutanneous injection is not feasible.

The Merck PDF document is available on the Web Archives site.
Archive.org ... AquaMEPHYTON_PI.pdf

Prescribing information for Vitamin K (Phytonadione)

http://fdb.rxlist.com/drugs/drug-9003-Aqua-Mephyton+Inj.aspx?drugid=9003&drugname=Aqua-Mephyton+Inj
Drugs & Medications - Aqua-Mephyton InjDrugs
VITAMIN K - INJECTION
Warnings
The injectable form of vitamin K can rarely cause severe (sometimes fatal) allergic reactions when given by injection into a muscle or vein. Therefore, vitamin K should be injected into a muscle or vein only when it cannot be given by injection under the skin or taken by mouth, or when your doctor has judged that the benefit is greater than the risk. Seek immediate medical attention if you experience symptoms of an allergic reaction such as rash, itching, swelling, dizziness, or trouble breathing.

http://www.drugs.com/cons/aquamephyton.html
Common names:
AquaMEPHYTON, Mephyton, phylloquinone , phytomenadione , vitamin K 1 , and vitamin K 4 .

Phytonadione is available in both Tablets and by injection.

See above link for a list of risks versus benefits.

http://www.drugs.com/cdi/phytonadione.html
Phytonadione is the generic name for Vitamin K.

http://content.nhiondemand.com/psv/monoAll-style.asp
Pharmasave library on Vitamin K (general info)




The link to Tubersol's package insert is available online here:
http://www.vaccineshoppe.com/index.cfm?fa=anon.piexpress
another version is here:
Commonly used brand name(s): Aplisol; Aplitest; Tuberculin PPD TINE TEST; Tubersol. http://www.drugs.com/MMX/Tuberculin__Purified_Protein_Derivative.html

Gen-Probe: AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST


Infanrix, DTaP, PediaRix, Infanrix hexa, many MISC Vaccines
Infanrix, DTaP vaccine package insert - 2002 - http://us.gsk.com/products/assets/us_infanrix.pdf

5 in 1 vaccine PediaRix Vaccine Package Insert http://us.gsk.com/products/assets/us_pediarix.pdf

Infanrix hexa (6 in 1 vaccine), package leaflet
European Public Assessment Report (EPAR)
http://www.eudra.org/humandocs/Humans/EPAR/Infanrixhexa/Infanrixhexa.htm
Package Leaflet for Infanrix hexa in 11 European languages, includes Danish, German, Greek, English, Spanish, Finnish, French, Italian, Dutch, Portuguese and Swedish.
The DTaP-HepB-IPV component is a white, slightly milky liquid presented in a prefilled syringe (0.5 ml).
The Hib component is a white powder presented in a glass vial. Both components must be mixed together...

M I S C

http://www.whale.to/vaccines/pack.html
Whale.to site has a page of links to Package Inserts

Prevnar 13 (New) Package Insert: http://www.wyeth.com/content/showlabeling.asp?id=501

Prevnar 7 (Old) Package Insert: http://www.wyeth.com/content/showlabeling.asp?id=134

Smallpox - Archived
[This vaccine has been replaced by a newer smallpox vaccine, see Military package inserts.
Smallpox Vaccine - Dryvax - (Wyeth) Revised 04-05
DRYVAX, Wyeth smallpox package insert formerly on US GOV site .PDF Rev. Oct. 2004
Now archived on wayback.archive.org

Smallpox Vaccine - Dryvax - (Wyeth) Revised 11/02.
If you dont want the .PDF file you can download the [archived] HTML file at:
http://web.archive.org/web/20021201115810/http://www.fda.gov/cber/label/smalwye102502LB.htm Rev. Nov 6, 2002


Animal Vaccines - Here:
Human Vaccines (Click)

Products, including vaccines, for animals:

https://animalhealth.pfizer.com/sites/pahweb/US/EN/Products/Pages/ProductsLanding.aspx