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Vaccine Package Inserts
[Links to Sources]

Human Vaccines - Here:
Animal Vaccines (Click)

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

For more Material Safety Data Sheets See: Animal Vaccines

Swine Flu Vaccines

2010-2011
Fluvirin®. 2010-2011 FORMULA

Fluzone, regular and high dose

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:

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, Merck Bayer, BioPort Corporation, GlaxoSmithKline, Aventis Pasteur, Mdimmune, Wyeth, Intercell Biomedical, NABI, Chiron, Mass Biol Labs, and Berna.

Package Inserts maintained by <Immunization Action Coalition [several manufacturers]

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


GlaxoXmithKline Vaccines
Trademark	Generic
ACWY Vax	meningococcal polysaccharides serogroups A, C, W135 and Y
Ambirix		Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Boostrix	tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed
Cervarix	Human Papillomavirus vaccine (types 16, 18) - recombinant, adjuvanted, adsorbed
Engerix-B	Hepatitis B Vaccine (Recombinant)
Fendrix		Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Fluarix		influenza vaccine
FluLaval	influenza vaccine
Havrix		hepatitis A vaccine, inactivated
Hepatyrix	Hepatitis A (inactivated, adsorbed) and Typhoid Polysaccharide vaccine
Hiberix		haemophilus B conjugate vaccine (tetanus toxoid conjugate)
Infanrix	diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed
Infanrix IPV	diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)
Infanrix IPV + HIB   diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated)
		and Haemophilus influenzae serotype b conjugate vaccine (adsorbed)
Influenza A 	(H1N1) 2009 / Monovalent Vaccine Influenza A (H1N1) 2009 Monovalent Vaccine
Kinrix		diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine
Menitorix	combined Haemophilus influenzae type b and Neisseria meningitidis group C (Hib-MenC) conjugate vaccines
Pandemrix	influenza vaccine (split virion, inactivated)
Pediarix	diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and
		inactivated poliovirus vaccine combined
Priorix		measles, mumps and rubella vaccine (live attenuated virus)
Rotarix		human rotavirus vaccine, live attenuated
Synflorix	Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Twinrix		combined hepatitis A (inactivated virus) and hepatitis B vaccine (genetically derived surface antigen)
Typherix	typhoid vaccine (purified polysaccharide antigen)
Varilrix	varicella in healthy adults and adolescents

Note the list above is subject to change.

FluMist package inserts: 2006-2007 PDR Drug information for Flumist Vaccine http://www.drugs.com/PDR/Flumist_Vaccine.html http://www.flumist.com/pdf/prescribinginfo.pdf 2006-2007 Formula http://www.medimmune.com/pdf/products/flumist_pi.pdf 2006-2007 Formula Other Flu Vaccine Package Inserts: 2006-2007 Name - Manufacturer Fluarix - GlaxoSmithKline \| http://us.gsk.com/products/assets/us_fluarix.pdf Fluvirin - Chiron \| http://www.fda.gov/Cber/label/inflchi072106LB1.pdf Fluzone - sanofi pasteur \| http://www.vaccineshoppe.com/index.cfm?fa=anon.piexpress FluMist - MedImmune \| http://www.medimmune.com/pdf/products/flumist_pi.pdf FluLaval - GlaxoSmithKline \|OK'ed October 5, 2006 for adults. http://www.fda.gov/cber/label/inflidb100506LB.pdf
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: If you do not find a Package Insert on the above site, then try the Cache managed by this site: http://poisonevercure.150m.com/vaccines/package_inserts/package_inserts.htm

L I N K :
Military website page with links to the following common vaccines: http://www.vaccines.mil/default.aspx?cnt=resource/quickReferenceCategories&sID=16

Anthrax
    Package Insert 31 Jan 02, Anthrax Vaccine Adsorbed (BioThrax)
    Package Insert PDF 27 Aug 02, Anthrax Vaccine (Spanish Version)

Chickenpox
    Package Insert 01 Dec 03, Chickenpox Vaccine (Merck) Diphtheria
    Daptacel (Aventis-Pateur) 01 Jan 03
    Tripedia (Aventis-Pasteur) 01 Dec 03
    Infanrix (GlaxoSmithKline) 01 Aug 03
DTaP
    Package Insert 02 Mar 04, DTaP (GlaxoSmithKline)
    Daptacel (Aventis-Pateur) 01 Jan 03
    Tripedia (Aventis-Pasteur) 01 Dec 03
    Infanrix (GlaxoSmithKline) 01 Aug 03
Haemophilus B
    Package Insert 01 Jan 04, Haemophilus B Vaccine (Merck)
    ActHIB (Aventis-Pasteur) 01 Sep 00
    PedvaxHIB (Merck) 26 Apr 04
    HibTITER (Wyeth) 26 Apr 04
Hepatitis A
    Vaqta (Merck) 01 Jan 04
    Havrix (GlaxoSmithKline) 03 Aug 03
Hepatitis B
    Recombivax (Merck) 01 Jun 03
    Engerix-B (GlaxoSmithKline) 01 Aug 04
Influenza
    Fluvirin (Chiron) 01 May 04
    Fluzone (Aventis-Pasteur) 01 Jun 04
    FluMist (MedImmune) 01 Sep 04
Japanese encephalitis
    JE-Vax (Aventis-Pasteur) 01 Feb 97
Measles
    M-M-R II (Merck) 01 Oct 03
Meningococcal
    Menomune (Aventis-Pasteur) 01 Jan 03
Mumps
    M-M-R II (Merck) 01 Oct 03
M-M-R II (Merck) 01 Oct 03
Pertussis
    Pertussis Vaccine (GlaxoSmithKline) 01 Aug 03
    Daptacel (Aventis-Pateur) 01 Jan 03
    Tripedia (Aventis-Pasteur) 01 Dec 03
    Infanrix (GlaxoSmithKline) 01 Aug 03
Pneumococcal
    Pneumovax (Merck) 01 May 04
Polio
    M-M-R II (Merck) 01 Oct 03
Ipol (Aventis-Pateur) 01 Dec 99
Rabies
    RabAvert (Chiron) 01 Aug 01
    Imovax (Aventis-Pasteur) 26 Apr 04
Rubella
    M-M-R II (Merck) 01 Oct 03
M-M-R II (Merck) 01 Oct 03
Smallpox
    Package Insert 27 Jan 04, Smallpox Vaccine (Wyeth)
Tetanus
    Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Aventis-Pasteur) 02 Jun 96
Tuberculosis (TB)
    Tubersol (Aventis-Pasteur) 01 Sep 01
Typhoid
    Vivotif (Berna) 02 Mar 04,
    Typhim Vi (Aventis-Pasteur) 26 Apr 04
Yellow Fever
    Y-F Vax (Aventis-Pasteur) 05 Dec 03

L I N K : MERCK Vaccines
Click on the vaccine, then click on Prescribing Information, https://www.merckvaccines.com/vaccineInfo_frmst.html

See the next section (below) for links to RotaVirus, MMRV and HepA vaccine Package Insert pages as well as information pages.

Vaccine Info: Vaccines
Flu (Afluria)
Gardasil (HPV4)
Haemophilus influenzae type b (Hib) (Recombivax HB)
Haemophilus influenzae type b, Meningococcal, and Hepatitis B (Comvax)
Haemophilus influenzae type b and Meningococcal (PedvaxHib)
Hepatitis A (Vaqta)
Hepatitis B
Hepatitis B/Hib
Measles, Mumps, Rubella (MMRII)
Pneumococcal Disease (PNEUMOVAX®23)
RotaVirus (RotaTeq)
Varicella (Varivax)
Zoster (Zostavax)

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

  -Merck's RotaTeq information: https://www.merckvaccines.com/rotateqProductPage_frmst.html

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

  -Merck's ProQuad (MMRV) information: https://www.merckvaccines.com/proquadProductPage_frmst.html

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

  -Merck's VAQTA/HepA information: https://www.merckvaccines.com/vaqtaProductPage_frmst.html

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

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

Denmark: BCG/Tuberculosis http://www.ssi.dk/sw2853.asp

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

Pentacel (Act-HIB® Reconstituted with QUADRACEL®) http://198.73.159.214/statics/vaccines/english/Pentacel_E.pdf

http://gskvaccines.com/vaccines/pages/utility_prescribing.jsp
Main page for GlaxoSmithKline package inserts, both Adult and Pediatric.
Adult Engerix-B®, Havrix®, Twinrix®, Malarone® (Malaria Tablets)
Pediatric Engerix-B®, Havrix®, Infanrix®, Malarone® (Malaria Tablets), Pediarix®

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

Package Inserts from http://www.biologicsconsulting.com/packageinserts.htm for:
Hoffman-La Roche, Inc, PEGASYS31A
Sanofi-Synthelabo, Inc, Elitek ET19980831A)
Aventis Pasteur Limited, DAPTACEL
Eli Lilly and Co, XigrisLET19980831A)
SmithKline Beecham Biologicals, 9980831A)
Pasteur T19980831A)
And several others

Vaccine Pkg Insert - DTaP - Certiva - Baxter.pdf

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

Rhogam Pkg insert. [Immuune Globulin (Human)]
http://www.babycenter.com/rhogam/info.pdf

Rotavirus Rotashield by Wyeth-Ayerst
"http://www.fda.gov/cber/label/rotawy083198lb.pdf

Smallpox Vaccine - Dryvax - (Wyeth) Revised 04-05
DRYVAX, Wyeth smallpox package insert on US GOV site .PDF Rev. Oct. 2004
Smallpox Vaccine - Dryvax - (Wyeth) Revised 11/02.
If you dont want the .PDF file you can download the HTML file at:
http://www.fda.gov/cber/label/smalwye102502LB.htm Rev. Nov 6, 2002

http://www.vaers.org/reportable.htm
Still have not found an insert? Several links are at the bottom of this Vaers page

Animal Vaccines - Here:
Human Vaccines (Click)

For Horses

Equine Rhinopneumonitis Vaccine
Modified Live Virus
Rhinomune®
http://www.pfizerah.com/PAHimages/compliance_pdfs/US_EN_RH_compliance.pdf

For calves

Main page to lead into the individual vaccines.
http://www.selectvac.com/program_info.asp?country=US&lang=EN&drug=PU&species=BF&s=2&id=1

BOVI-SHIELD® 4
Injectable
Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza3-Respiratory SyncytialVirus
Vaccine
http://www.pfizerah.com/PAHimages/compliance_pdfs/US_EN_B4_compliance.pdf

MATERIAL SAFETY DATA SHEET
http://www.pfizerah.com/PAHimages/msds_us/B4.pdf

CATTLEMASTER® 4 Injectable
Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza3-Respiratory Syncytial Virus
Vaccine Modified Live and Killed Virus
CattleMaster® 4
http://www.pfizerah.com/PAHimages/compliance_pdfs/US_EN_CM_compliance.pdf

MATERIAL SAFETY DATA SHEET
http://www.pfizerah.com/PAHimages/msds_us/CM.pdf

BOVI-SHIELD™ BRSV
Injectable
http://www.pfizerah.com/PAHimages/compliance_pdfs/US_EN_BH_compliance.pdf

MATERIAL SAFETY DATA SHEET
http://www.pfizerah.com/PAHimages/msds_us/BH.pdf