|
Excipient
|
Type
|
Vaccine Name
|
Vaccine Type
|
Amount
|
|
2-Phenoxyethanol
|
Stabilizer
|
Adacel
|
Tdap
|
Not as a preservative
|
|
2-Phenoxyethanol
|
Stabilizer
|
Daptacel
|
DTaP
|
3.3 mg (0.6% v/v) (not as a preservative)
|
|
2-Phenoxyethanol
|
Preservative
|
IPOL
|
Polio
|
0.5% (as a preservative)
|
|
2-Phenoxyethanol
|
Stabilizer
|
Pentacel
|
DTaP+IPV+Hib
|
3.3 mg (0.65 v/v) (not as a preservative)
|
|
3-O-desacyl-4’-monophosphoryl lipid A (MPL)
|
Adjuvant
|
Cervarix
|
HPV
|
50 mcg
|
|
Albumin, Bovine
|
Stabilizer
|
Ixiaro
|
Japanese Encephalitis
|
≤ 100 ng/mL
|
|
Albumin, Bovine
|
Stabilizer
|
Vaqta
|
HepA
|
.1 ng
|
|
Albumin, Calf Serum
|
Stabilizer
|
Kinrix
|
DTaP+IPV
|
VERO cell culture growth
|
|
Albumin, Calf Serum
|
Stabilizer
|
Zostavax
|
Zoster
|
Trace amounts
|
|
Albumin, Calf Serum Protein
|
Stabilizer
|
IPOL
|
IPV
|
< 1 ppm
|
|
Albumin, Calf Serum Protein
|
Stabilizer
|
Pediarix
|
DTaP+HepB+IPV
|
≤ 50 ng residual
|
|
Albumin, Calf Serum Protein
|
Stabilizer
|
Pentacel
|
DTaP+IPV+Hib
|
Supplements CMRL 1969 medium
|
|
Albumin, Egg (Ovalbumin)
|
Residual Medium
|
Afluria
|
Influenza
|
≤ 1 mcg
|
|
Albumin, Egg (Ovalbumin)
|
Residual Medium
|
Fluarix
|
Influenza
|
≤ 0.05 mcg
|
|
Albumin, Egg (Ovalbumin)
|
Residual Medium
|
Flulaval
|
Influenza
|
≤ 0.3 mcg
|
|
Albumin, Egg (Ovalbumin)
|
Residual Medium
|
FluMist
|
Influenza
|
≤ 0.24 mcg
|
|
Albumin, Egg (Ovalbumin)
|
Residual Medium
|
Fluvirin
|
Influenza
|
≤ 1 mcg
|
|
Albumin, Egg (Ovalbumin)
|
Residual Medium
|
FluZone
|
Influenza
|
Limited quantity
|
|
Albumin, Egg (Ovalbumin)
|
Residual Medium
|
RabAvert
|
Rabies
|
< 3 ng/dose
|
|
Albumin, Fetal Bovine Serum
|
Stabilizer
|
MMR-II
|
MMR
|
< 1 ppm
|
|
Albumin, Fetal Bovine Serum
|
Stabilizer
|
ProQuad
|
MMRV
|
0.5 mcg
|
|
Albumin, Fetal Bovine Serum
|
Stabilizer
|
RotaTeq
|
Rotavirus
|
Trace amounts
|
|
Albumin, Fetal Bovine Serum
|
Stabilizer
|
Varivax
|
Varicella
|
Trace amounts
|
|
Albumin, Human Serum
|
Diluent/Stabilizer
|
ACAM2000
|
Smallpox
|
2%
|
|
Albumin, Human
|
Stabilizer
|
Imovax
|
Rabies
|
< 100 mg
|
|
Albumin, Human Serum
|
Diluent/Stabilizer
|
MMR-II
|
MMR
|
≤ 0.3 mg
|
|
Albumin, Human Serum
|
Diluent/Stabilizer
|
ProQuad
|
MMRV
|
0.31 mg
|
|
Albumin, Human Serum
|
Diluent/Stabilizer
|
RabAvert
|
Rabies
|
< 0.3 mg
|
|
Aluminum
|
Adjuvant
|
Adacel
|
Tdap
|
0.33 mg
|
|
Aluminum
|
Adjuvant
|
BioThrax
|
Anthrax
|
1.2 mg/mL
|
|
Aluminum
|
Adjuvant
|
Boostrix
|
Tdap
|
≤ 0.39 mg
|
|
Aluminum
|
Adjuvant
|
Cervarix
|
HPV
|
0.5 mg aluminum hydroxide
|
|
Aluminum
|
Adjuvant
|
Comvax
|
Hib+HepB
|
225 mcg
|
|
Aluminum
|
Adjuvant
|
Daptacel
|
DTaP
|
0.33 mg
|
|
Aluminum
|
Adjuvant
|
DT
|
DT
|
≤ 0.17 mg
|
|
Aluminum
|
Adjuvant
|
Engerix-B
|
HepB
|
0.5 mg/mL as aluminum hydroxide
|
|
Aluminum
|
Adjuvant
|
Gardasil
|
HPV
|
225 mcg
|
|
Aluminum
|
Adjuvant
|
Havrix
|
HepA
|
0.5 mg/mL as aluminum hydroxide
|
|
Aluminum
|
Adjuvant
|
Infanrix
|
DTaP
|
≤ 0.625 mg
|
|
Aluminum
|
Adjuvant
|
Ixiaro
|
Japanese Encephalitis
|
250 mcg aluminum hydroxide
|
|
Aluminum
|
Adjuvant
|
Kinrix
|
DTaP+IPV
|
≤ 0.6 mg
|
|
Aluminum
|
Adjuvant
|
Pediarix
|
DTaP+HepB+IPV
|
≤ 0.85 mg
|
|
Aluminum
|
Adjuvant
|
PedvaxHIB
|
Hib+HepB
|
225 mcg
|
|
Aluminum
|
Adjuvant
|
Pentacel
|
DTaP+IPV+Hib
|
0.33 mg
|
|
Aluminum
|
Adjuvant
|
Prevnar
|
Pneumococcal 7-valent
|
0.125 mg
|
|
Aluminum
|
Adjuvant
|
Prevnar 13
|
Pneumococcal 13-valent
|
0.125 mg
|
|
Aluminum
|
Adjuvant
|
Recombivax HB
|
HepB
|
0.5 mg/mL
|
|
Aluminum
|
Adjuvant
|
Td
|
Td
|
≤ 0.53 mg
|
|
Aluminum
|
Adjuvant
|
Twinrix
|
HepA+HepB
|
0.45 mg
|
|
Aluminum
|
Adjuvant
|
Vaqta
|
HepA
|
0.45 mg/mL (0.225 mg in ped dose)
|
|
Amino Acid
|
Medium Nutrient
|
BioThrax
|
Anthrax
|
Unspecified amount in growth medium
|
|
Amino Acid
|
Medium Nutrient
|
Cervarix
|
HPV
|
Unspecified amount in growth medium
|
|
Amino Acid
|
Medium Nutrient
|
Comvax
|
Hib+HepB
|
Unspecified amount in growth medium
|
|
Amino Acid
|
Medium Nutrient
|
Flublok
|
Influenza
|
In growth medium
|
|
Amino Acid
|
Medium Nutrient
|
FluMist
|
Influenza
|
2.42 mg/dose Arginine
|
|
Amino Acid
|
Medium Nutrient
|
Gardasil
|
HPV
|
In growth medium
|
|
Amino Acid
|
Medium Nutrient
|
Havrix
|
HepA
|
0.3% w/v
|
|
Amino Acid
|
Medium Nutrient
|
Menveo
|
Meningococcal
|
In growth medium
|
|
Amino Acid
|
Medium Nutrient
|
MMR-II
|
MMR
|
In growth medium
|
|
Amino Acid
|
Medium Nutrient
|
PedvaxHIB
|
Hib+HepB
|
Amount not specified in Package Insert
|
|
Amino Acid
|
Medium Nutrient
|
Recombivax HB
|
HepB
|
In fermentation medium
|
|
Amino Acid
|
Medium Nutrient
|
Rotarix
|
Rotavirus
|
In DMEM (Dulbecco's Modified Eagle Medium)
|
|
Amino Acid
|
Medium Nutrient
|
Twinrix
|
HepA+HepB
|
Amount not specified in Package Insert
|
|
Amino Acid
|
Medium Nutrient
|
Vivotif
|
Typhoid
|
1.4-7 mg/capsule
|
|
Ammonium Sulfate
|
Protein Purifier
|
ActHIB
|
Hib
|
Ingredient in purification
|
|
Ammonium Sulfate
|
Protein Purifier
|
Adacel
|
Tdap
|
Ingredient in purification
|
|
Ammonium Sulfate
|
Protein Purifier
|
Daptacel
|
DTaP
|
Ingredient in purification
|
|
Ammonium Sulfate
|
Protein Purifier
|
DT
|
DT
|
Ingredient in purification
|
|
Ammonium Sulfate
|
Protein Purifier
|
Pentacel
|
DTaP+IPV+Hib
|
Ingredient in purification
|
|
Ammonium Sulfate
|
Protein Purifier
|
Prevnar
|
Pneumococcal 7-valent
|
Ingredient in purification
|
|
Ammonium Sulfate
|
Protein Purifier
|
Prevnar 13
|
Pneumococcal 13-valent
|
Ingredient in purification
|
|
Ammonium Sulfate
|
Protein Purifier
|
Td
|
Td
|
Ingredient in purification
|
|
Amphotericin B
|
Antimicrobial
|
RabAvert
|
Rabies
|
< 2 ng
|
|
Ascorbic Acid
|
Anitoxidant
|
Vivotif
|
Typhoid
|
1-5 mg/capsule
|
|
Benzethonium Chloride
|
Preservative
|
BioThrax
|
Anthrax
|
25 mcg/mL
|
|
Beta-Propiolactone
|
Viral Inactivator
|
Afluria
|
Influenza
|
< 2 ng
|
|
Beta-Propiolactone
|
Viral Inactivator
|
Flucelvax
|
Influenza
|
≤ 0.5 mcg
|
|
Beta-Propiolactone
|
Viral Inactivator
|
Fluvirin
|
Influenza
|
≤ 5 mcg
|
|
Beta-Propiolactone
|
Viral Inactivator
|
Imovax
|
Rabies
|
< 50 ppm
|
|
Bovine Casein
|
Medium Nutrient
|
Boostrix
|
Tdap
|
Amount not specified in Package Insert
|
|
Bovine Casein
|
Medium Nutrient
|
Infanrix
|
DTaP
|
12.2-18.3 ng/mL
|
|
Bovine Casein
|
Medium Nutrient
|
Kinrix
|
DTaP+IPV
|
Ingredient in Latham medium
|
|
Bovine Casein
|
Medium Nutrient
|
Pediarix
|
DTaP+HepB+IPV
|
Ingredient of Latham medium
|
|
Bovine Casein
|
Medium Nutrient
|
Vivotif
|
Typhoid
|
Ingredient in medium
|
|
Bovine Extract
|
Medium Nutrient
|
Boostrix
|
Tdap
|
Amount not specified in Package Insert
|
|
Bovine Extract
|
Medium Nutrient
|
DT
|
DT
|
Amount not specified in Package Insert
|
|
Bovine Extract
|
Stabilizer
|
Infanrix
|
DTaP
|
Ingredient in Fenton medium
|
|
Bovine Extract
|
Stabilizer
|
Kinrix
|
DTaP+IPV
|
Ingredient in Fenton medium
|
|
Bovine Extract
|
Stabilizer
|
Pediarix
|
DTaP+HepB+IPV
|
Ingredient of Fenton medium
|
|
Bovine Extract
|
Stabilizer
|
Td
|
Td
|
Ingredient in Mueller's media
|
|
Bovine, Casamino Acid
|
Stabilizer
|
Adacel
|
Tdap
|
8.1-17.3 ng/mL
|
|
Bovine, Casamino Acid
|
Stabilizer
|
Daptacel
|
DTaP
|
10 ng/mL
|
|
Bovine, Casamino Acid
|
Stabilizer
|
Menomune
|
Meningococcal
|
Ingredient in growth medium
|
|
Bovine, Casamino Acid
|
Stabilizer
|
Pentacel
|
DTaP+IPV+Hib
|
Ingredient in growth medium
|
|
Bovine, Casamino Acid
|
Stabilizer
|
Prevnar
|
Pneumococcal 7-valent
|
Ingredient in growth medium
|
|
Bovine, Casamino Acid
|
Stabilizer
|
Prevnar 13
|
Pneumococcal 13-valent
|
Ingredient in growth medium
|
|
Calcium Carbonate
|
Buffer
|
Rotarix
|
Rotavirus
|
Ingredient in diluent
|
|
Calcium Chloride
|
Medium Nutrient
|
Afluria
|
Influenza
|
1.5 mcg
|
|
Calcium Chloride
|
Medium Nutrient
|
Rotarix
|
Rotavirus
|
In DMEM (Dulbecco’s Modified Eagle Medium)
|
|
Carbohydrates
|
Medium Nutrient
|
Gardasil
|
HPV
|
Ingredient in fermentation medium
|
|
Cetyltrimethylammonium Bromide (CTAB)
|
Protein Purifier
|
Agriflu
|
Influenza
|
≤ 12 mcg
|
|
CTAB
|
Protein Purifier
|
Flucelvax
|
Influenza
|
≤ 13.5 mcg
|
|
Chick Embryo
|
Residual Medium
|
MMR-II
|
MMR
|
No intact cells (may have trace residual protein)
|
|
Chick Embryo
|
Residual Medium
|
ProQuad
|
MMRV
|
No intact cells (may have trace residual protein)
|
|
Chick fibroblasts
|
Protein Purifier
|
RabAvert
|
Rabies
|
Growth medium
|
|
Chlortetracycline
|
Antimicrobial
|
RabAvert
|
Rabies
|
1 mcg
|
|
Dextrose
|
Medium Nutrient
|
Comvax
|
Hib+HepB
|
Amount not specified in Package Insert
|
|
Dextrose
|
Medium Nutrient
|
Recombivax HB
|
HepB
|
Ingredient of fermentation medium
|
|
Dextrose
|
Medium Nutrient
|
TwinRix
|
HepA+HepB
|
Amount not specified in Package Insert
|
|
Dextrose
|
Medium Nutrient
|
Vivotif
|
Typhoid
|
Ingredient in medium
|
|
D-glucose
|
Medium Nutrient
|
Rotarix
|
Rotavirus
|
In DMEM (Dulbecco’s Modified Eagle Medium)
|
|
Dimethyl-beta-cyclodextrin
|
Medium Nutrient
|
Adacel
|
Tdap
|
Amount not specified in Package Insert
|
|
Dimethyl-beta-cyclodextrin
|
Medium Nutrient
|
Daptacel
|
DTaP
|
Amount not specified in Package Insert
|
|
Dimethyl-beta-cyclodextrin
|
Medium Nutrient
|
Pentacel
|
DTaP+IPV+Hib
|
Ingredient of Stainer-Scholte medium
|
|
DNA
|
Residual Medium
|
Flublok
|
Influenza
|
≤ 10 ng
|
|
DNA
|
Residual Medium
|
Flucelvax
|
Influenza
|
≤ 10 ng MDCK cell
|
|
DNA
|
Residual Medium
|
Ixiaro
|
Japanese Encephalitis
|
≤ 200 pg/mL ('host cell DNA')
|
|
DNA
|
Residual Medium
|
ProQuad
|
MMRV
|
Residual component of MRC-5 cells
|
|
DNA
|
Residual Medium
|
RotaTeq
|
Rotavirus
|
|
|
DNA
|
Residual Medium
|
Vaqta
|
HepA
|
< 4 x 10–6 mcg
|
|
DNA
|
Residual Medium
|
Varivax
|
Varicella
|
Residual component of MRC-5 cells
|
|
DNA
|
Residual Medium
|
Zostavax
|
Zoster
|
Residual component of MRC-5 cells
|
|
Egg Protein
|
Residual Medium
|
Fluvirin
|
Influenza
|
≤ 1 mcg ovalbumin
|
|
Egg, Allantoic fluid
|
Residual Medium
|
FluMist
|
Influenza
|
Amount not specified in Package Insert
|
|
Ethylene diamine-Tetracetic Acid Sodium (EDTA)
|
Preservative
|
FluMist
|
Influenza
|
< 0.37 mcg/dose
|
|
EDTA
|
Preservative
|
RabAvert
|
Rabies
|
0.3 mg sodium EDTA
|
|
EDTA
|
Preservative
|
Varivax
|
Varicella
|
Trace amounts
|
|
Ferric (III) Nitrate
|
Medium Nutrient
|
Rotarix
|
Rotavirus
|
In DMEM (Dulbecco’s Modified Eagle Medium)
|
|
Formaldehyde
|
Inactivating Agent
|
ActHIB
|
Hib
|
< 0.5 mcg
|
|
Formaldehyde
|
Inactivating Agent
|
Adacel
|
Tdap
|
≤ 5 mcg
|
|
Formaldehyde
|
Inactivating Agent
|
Agriflu
|
Influenza
|
≤ 10 mcg
|
|
Formaldehyde
|
Inactivating Agent
|
BioThrax
|
Anthrax
|
100 mg/mL
|
|
Formaldehyde
|
Inactivating Agent
|
Boostrix
|
Tdap
|
≤ 100 mcg (residual)
|
|
Formaldehyde
|
Inactivating Agent
|
Comvax
|
Hib+HepB
|
≤ 0.0004% (w/v) residual
|
|
Formaldehyde
|
Inactivating Agent
|
Daptacel
|
DTaP
|
≤ 5 mcg (residual)
|
|
Formaldehyde
|
Inactivating Agent
|
DT
|
DT
|
< 0.02%
|
|
Formaldehyde
|
Inactivating Agent
|
Fluarix
|
Influenza
|
≤ 5 mcg
|
|
Formaldehyde
|
Inactivating Agent
|
Flulaval
|
Influenza
|
≤ 25 mcg
|
|
Formaldehyde
|
Inactivating Agent
|
FluZone
|
Influenza
|
≤ 100 mcg/.5mL in Fluzone
|
|
Formaldehyde
|
Inactivating Agent
|
FluZone Intradermal
|
Influenza
|
≤ 20 mcg in Fluzone Intradermal
|
|
Formaldehyde
|
Inactivating Agent
|
Havrix
|
HepA
|
≤ 0.1 mg/mL formalin
|
|
Formaldehyde
|
Inactivating Agent
|
Hiberix
|
Hib
|
< 0.5 mcg (residual)
|
|
Formaldehyde
|
Inactivating Agent
|
Infanrix
|
DTaP
|
≤ 100 mcg (residual)
|
|
Formaldehyde
|
Inactivating Agent
|
IPOL
|
Polio
|
≤ 0.02%
|
|
Formaldehyde
|
Inactivating Agent
|
Ixiaro
|
Japanese Encephalitis
|
≤ 200 pmm
|
|
Formaldehyde
|
Inactivating Agent
|
JE-Vax
|
Japanese Encephalitis
|
< 100 mcg
|
|
Formaldehyde
|
Inactivating Agent
|
Kinrix
|
DTaP+IPV
|
≤ 100 mcg (residual)
|
|
Formaldehyde
|
Inactivating Agent
|
Menhibrix
|
Meningococcal CY+Hib
|
≤ 0.72 mcg
|
|
Formaldehyde
|
Inactivating Agent
|
Menactra
|
Meningococcal
|
< 2.66 mcg
|
|
Formaldehyde
|
Inactivating Agent
|
Menveo
|
Meningococcal
|
≤ 0.3 mcg
|
|
Formaldehyde
|
Inactivating Agent
|
Pediarix
|
DTaP+HepB+IPV
|
≤ 100 mcg (residual)
|
|
Formaldehyde
|
Inactivating Agent
|
Pentacel
|
DTaP+IPV+Hib
|
≤ 5 mcg (residual)
|
|
Formaldehyde
|
Inactivating Agent
|
Recombivax HB
|
HepB
|
< 15 mcg/mL (residual)
|
|
Formaldehyde
|
Inactivating Agent
|
Td
|
Td
|
< 100 mcg
|
|
Formaldehyde
|
Inactivating Agent
|
Twinrix
|
HepA+HepB
|
≤ 0.1 mg formalin
|
|
Formaldehyde
|
Inactivating Agent
|
Vaqta
|
HepA
|
< 0.8 mcg
|
|
Galactose
|
Medium Nutrient
|
Vivotif
|
Typhoid
|
Ingredient in medium
|
|
Gelatin
|
Stabilizer
|
FluZone
|
Influenza
|
0.05% in 0.25 mL and 0.5 mL Fluzone
None in Fluzone HiDose or Intradermal
|
|
Gelatin
|
Manufacturing residue
|
JE-Vax
|
Japanese Encephalitis
|
500 mcg
|
|
Gelatin
|
Stabilizer
|
YF-Vax
|
Yellow Fever
|
Amount not specified in Package Insert
|
|
Gelatin, Bovine
|
Stabilizer, solvent
|
RabAvert
|
Rabies
|
12 mg polygeline
|
|
Gelatin, hydrolyzed
|
Stabilizer
|
MMR-II
|
MMR
|
14.5 mg
|
|
Gelatin, hydrolyzed
|
Stabilizer
|
ProQuad
|
MMRV
|
11 mg
|
|
Gelatin, hydrolyzed
|
Stabilizer
|
Varivax
|
Varicella
|
12.5 mg
|
|
Gelatin, Porcine, Hydrolyzed
|
Stabilizer
|
FluMist
|
Influenza
|
2.00 mg/0.2 mLdose
|
|
Gelatin, Porcine, Hydrolyzed
|
Stabilizer
|
Zostavax
|
Varicella Zoster
|
15.58 mg
|
|
Gentamicin Sulfate
|
Antimicrobial
|
Fluarix
|
Influenza
|
≤ 0.15 mcg
|
|
Gentamicin Sulfate
|
Antimicrobial
|
FluMist
|
Influenza
|
< 0.015 mcg/mL
|
|
Glutamate
|
Medium Nutrient
|
MMR-II
|
MMR
|
Ingredient in growth medium (Medium 199)
|
|
Glutaraldehyde
|
Inactivating Agent
|
Adacel
|
Tdap
|
< 50 ng (residual)
|
|
Glutaraldehyde
|
Inactivating Agent
|
Boostrix
|
Tdap
|
Amount not specified in Package Insert
|
|
Glutaraldehyde
|
Inactivating Agent
|
Daptacel
|
DTaP
|
< 50 ng (residual)
|
|
Glutaraldehyde
|
Inactivating Agent
|
Infanrix
|
DTaP
|
Amount not specified in Package Insert
|
|
Glutaraldehyde
|
Inactivating Agent
|
Kinrix
|
DTaP+IPV
|
Amount not specified in Package Insert
|
|
Glutaraldehyde
|
Inactivating Agent
|
Pediarix
|
DTaP+HepB+IPV
|
Amount not specified in Package Insert
|
|
Glutaraldehyde
|
Inactivating Agent
|
Pentacel
|
DTaP+IPV+Hib
|
< 50 ng (residual)
|
|
Glycerin
|
Stabilizer
|
ACAM2000
|
Smallpox
|
50% v/v in diluent
|
|
HEPES
|
Buffer
|
ACAM2000
|
Smallpox
|
6-8 mM
|
|
Hexadecyltrimethylammonium Bromide
|
Protein Purifier
|
Typhim Vi
|
Typhoid
|
Amount not specified in Package Insert
|
|
Hydrocortisone
|
Medium Nutrient
|
Fluarix
|
Influenza
|
≤ 0.0016 mcg
|
|
Insect cell
|
Residual medium
|
Cervarix
|
HPV
|
≤ 40 ng
|
|
Kanamycin
|
Antimicrobial
|
Agriful
|
Influenza
|
≤ 0.03 mcg
|
|
Lactalbumin Hydrolysate
|
Medium Nutrient
|
Kinrix
|
DTaP+IPV
|
Ingredient in growth medium
|
|
Lactalbumin Hydrolysate
|
Medium Nutrient
|
Pediarix
|
DTaP+HepB+IPV
|
Ingredient in growth medium
|
|
Lactose
|
Stabilizer
|
Hiberix
|
Hib
|
12.6 mg
|
|
Lactose
|
Stabilizer
|
Meactra
|
Meningococcal
|
2.5-5 mg
|
|
Lactose
|
Stabilizer
|
Menomune
|
Meningococcal
|
2.5-5 mg
|
|
Lactose
|
Stabilizer
|
Vivotif
|
Typhoid
|
100-180 mg/capsule
|
|
L-cystine
|
Medium Nutrient
|
Rotarix
|
Rotavirus
|
Amount not specified in Package Insert
|
|
L-histidine
|
Medium Nutrient
|
Gardasil
|
HPV
|
0.78 mg
|
|
L-tyrosine
|
Medium Nutrient
|
Rotarix
|
Rotavirus
|
Amount not specified in Package Insert
|
|
Magnesium Stearate
|
Lubricant for capsule filling
|
Vivotif
|
Typhoid
|
3.6-4.4 mg/capsule
|
|
Magnesium Sulfate
|
Medium Nutrient
|
Rotarix
|
Rotavirus
|
Amount not specified in Package Insert
|
|
Mannitol
|
Stabilizer
|
ACAM2000
|
Smallpox
|
5%
|
|
Monosodium glutamate
|
Stabilizer
|
FluMist
|
Influenza
|
0.188 mg/0.2 mL dose
|
|
Monosodium L-glutamate
|
Stabilizer
|
ProQuad
|
MMRV
|
0.40 mg
|
|
Monosodium L-glutamate
|
Stabilizer
|
Zostavax
|
Varicella Zoster
|
0.62 mg
|
|
Monosodium L-glutimate
|
Stabilizer
|
Varivax
|
Varicella
|
0.5 mg
|
|
Mouse Serum Protein
|
Manufacturing residue
|
JE-Vax
|
Japanese Encephalitis
|
< 50 ng
|
|
MRC-5
|
Manf residue
|
Havrix
|
HepA
|
≤ 5 mcg/mL
|
|
MRC-5
|
Manf residue
|
Imovax
|
Rabies
|
Amount not specified in Package Insert
|
|
MRC-5
|
Growth Medium
|
Pentacel
|
DTaP+IPV+Hib
|
Amount not specified in Package Insert
|
|
MRC-5
|
Manf residue
|
ProQuad
|
MMRV
|
Residual
|
|
MRC-5
|
Manf residue
|
Twinrix
|
HepA+HepB
|
≤2.5 mcg
|
|
MRC-5
|
Manf residue
|
Vaqta
|
HepA
|
Amount not specified in Package Insert
|
|
MRC-5
|
Manf residue
|
Varivax
|
Varicella
|
Residual components
|
|
MRC-5
|
Manf residue
|
Zostavax
|
Varicella Zoster
|
Residual
|
|
Neomycin
|
Antimicrobial
|
ACAM2000
|
Smallpox
|
Trace amounts
|
|
Neomycin
|
Antimicrobial
|
Agriflu
|
Influenza
|
≤0.02 mcg (residual amounts)
|
|
Neomycin
|
Antimicrobial
|
Fluvirin
|
Influenza
|
≤2.5 mcg
|
|
Neomycin
|
Antimicrobial
|
IPOL
|
IPV
|
< 5 ng
|
|
Neomycin
|
Antimicrobial
|
Kinrix
|
DTaP+IPV
|
≤ 0.05 ng
|
|
Neomycin
|
Antimicrobial
|
MMR-II
|
MMR
|
25 mcg
|
|
Neomycin
|
Antimicrobial
|
Pediarix
|
DTaP+HepB+IPV
|
≤ 0.05 ng
|
|
Neomycin
|
Antimicrobial
|
Pentacel
|
DTaP+IPV+Hib
|
< 4 pg
|
|
Neomycin
|
Antimicrobial
|
ProQuad
|
MMRV
|
< 16 mcg
|
|
Neomycin
|
Antimicrobial
|
RabAvert
|
Rabies
|
<1 mcg
|
|
Neomycin
|
Antimicrobial
|
Vaqta
|
HepA
|
< 10 ppb (residual amount)
|
|
Neomycin
|
Antimicrobial
|
Varivax
|
Varicella
|
Trace amounts
|
|
Neomycin
|
Antimicrobial
|
Zostavax
|
Varicella Zoster
|
Trace amounts
|
|
Neomycin Sulfate
|
Antimicrobial
|
Afluria
|
Influenza
|
≤3 ng
|
|
Neomycin Sulfate
|
Antimicrobial
|
Havrix
|
HepA
|
≤ 40 ng/mL
|
|
Neomycin Sulfate
|
Antimicrobial
|
Imovax
|
Rabies
|
<150 mcg
|
|
Neomycin Sulfate
|
Antimicrobial
|
Twinrix
|
HepA+HepB
|
≤ 20 ng
|
|
Nonylphenol Ethoxylate
|
Surfacant
|
Fluvirin
|
Influenza
|
≤0.015% w/v
|
|
Octoxynol-10 (Triton X-100)
|
Surfactant
|
Fluarix
|
Influenza
|
≤ 0.085 mg
|
|
Octylphenol Ethoxylate (Triton X-100)
|
Surfactant
|
FluZone
|
Influenza
|
≤ 150 mcg/0.5mL Fluzone
≤250 mcg in Fluzone HiDose
≤50 mcg in Fluzone Intradermal
|
|
Peptone
|
Medium Nutrient
|
DT
|
TD
|
Amount not specified in Package Insert
|
|
Peptone, Soy
|
Medium Nutrient
|
Comvax
|
Hib+HepB
|
Amount not specified in Package Insert
|
|
Peptone, Soy
|
Medium Nutrient
|
Prevnar
|
Pneumococcal 7-valent
|
Growth medium
|
|
Peptone, Soy
|
Medium Nutrient
|
Prevnar 13
|
Pneumococcal 13-valent
|
Growth medium
|
|
Peptone, Soy
|
Medium Nutrient
|
Recombivax HB
|
HepB
|
Ingredient of fermentation medium
|
|
Phenol
|
Preservative, antibacterial
|
ACAM2000
|
Smallpox
|
0.25% v/v in diluent
|
|
Phenol
|
Preservative, antibacterial
|
Comvax
|
Hib+HepB
|
Ingredient in purification procedure
|
|
Phenol
|
Preservative, antibacterial
|
PedvaxHIB
|
Hib+HepB
|
Ingredient in purification procedure
|
|
Phenol
|
Preservative
|
Pneumovax 23
|
Pneumococcal 23-valent
|
Saline containing 0.25% phenol
|
|
Phenol
|
Preservative, antibacterial
|
Typhim Vi
|
Typhoid
|
0.25%
|
|
Phenol Red Indicator
|
pH indicator, dye
|
Imovax
|
Rabies
|
20 mcg
|
|
Phenol Red Indicator
|
pH indicator, dye
|
Rotarix
|
Rotavirus
|
Ingredient of Growth Medium
|
|
Phosphate Buffer
|
Buffer
|
Afluria
|
Influenza
|
20 mcg potassium phosphate monobasic
80 mcg sodium phosphate monobasic
300 mcg sodium phosphate dibasic
|
|
Phosphate Buffer
|
Buffer
|
Cervarix
|
HPV
|
0.624 mg sodium dihydrogen phosphate dihydrate
|
|
Phosphate Buffer
|
Buffer
|
Engerix-B
|
HepB
|
0.98 mg/mL Disodium Phosphate Dihydrate
0.71 mg/mL Sodium Dihydrogen Phosphate Dihydrate
|
|
Phosphate Buffer
|
Buffer
|
Flublok
|
Influenza
|
0.195 mcg sodium phosphate monobasic
1.3 mg sodium phosphate dibasic
|
|
Phosphate Buffer
|
Buffer
|
FluMist
|
Influenza
|
0.96 mg/0.2 mL dose potassium phosphate monobasic
2.26 mg/dose potassium phosphate dibasic
|
|
Phosphate Buffer
|
Buffer
|
FluZone
|
Influenza
|
Sodium phosphate-buffered isotonic sodium chloride solution - “quantity sufficient to appopriate volume”
|
|
Phosphate Buffer
|
Buffer
|
Havrix
|
HepA
|
Phosphate-buffered saline solution
|
|
Phosphate Buffer
|
Buffer
|
Ixiaro
|
Japanese Encephalitis
|
potassium dihydrogen phosphate
0.5 mL phosphate buffered saline
|
|
Phosphate Buffer
|
Buffer
|
Menactra
|
Meningococcal
|
Amount not specified in Package Insert
|
|
Phosphate Buffer
|
Buffer
|
MMR-II
|
MMR
|
Sodium phosphate
|
|
Phosphate Buffer
|
Buffer
|
ProQuad
|
MMRV
|
36 mcg potassium phosphate dibasic
72 mcg potassium phosphate monobasic
0.34 mg sodium phosphate dibasic
|
|
Phosphate Buffer
|
Buffer
|
Rotarix
|
Rotavirus
|
Sodium phosphate in DMEM (medium)
|
|
Phosphate Buffer
|
Buffer
|
RotaTeq
|
Rotavirus
|
Sodium phosphate monobasic monohydrate
|
|
Phosphate Buffer
|
Buffer
|
Twinrix
|
HepA+HepB
|
Amount not specified in Package Insert
|
|
Phosphate Buffer
|
Buffer
|
Typhim Vi
|
Typhoid
|
0.065 mg Disodium Phosphate
0.023 mg Monosodium Phosphate
|
|
Phosphate Buffer
|
Buffer
|
Varivax
|
Varicella
|
0.08 mg potassium phosphate monobasic
0.45 mg sodium phosphate dibasic
Sodium phosphate monobasic, trace amounts
|
|
Phosphate Buffer
|
Buffer
|
Zostavax
|
Varicella Zoster
|
0.10 mg potassium phosphate monobasic
0.57 mg sodium phosphate monobasic
|
|
Polymyxin
|
Antimicrobial
|
Fluvirin
|
Influenza
|
≤3.75 mcg
|
|
Polymyxin B
|
Antimicrobial
|
ACAM2000
|
Smallpox
|
Trace amounts
|
|
Polymyxin B
|
Antimicrobial
|
Afluria
|
Influenza
|
≤ 0.5 ng
|
|
Polymyxin B
|
Antimicrobial
|
IPOL
|
Polio
|
25 ng
|
|
Polymyxin B
|
Antimicrobial
|
Kinrix
|
DTaP+IPV
|
≤ 0.01 ng
|
|
Polymyxin B
|
Antimicrobial
|
Pediarix
|
DTaP+HepB+IPV
|
≤ 0.01 ng
|
|
Polymyxin B
|
Antimicrobial
|
Pentacel
|
DTaP+IPV+Hib
|
< 4 pg
|
|
Polysorbate 20
|
Surfactant
|
Flublok
|
Influenza
|
≤ 27.5 mcg (Tween 20)
|
|
Polysorbate 20
|
Surfactant
|
Havrix
|
HepA
|
0.05 mg/mL
|
|
Polysorbate 20
|
Surfactant
|
Twinrix
|
HepA+HepB
|
Amount not specified in Package Insert
|
|
Polysorbate 80
|
Surfactant
|
Agriflu
|
Influenza
|
≤ 50 mcg
|
|
Polysorbate 80
|
Surfactant
|
Boostrix
|
Tdap
|
≤ 100 mcg (Tween 80)
|
|
Polysorbate 80
|
Surfactant
|
Fluarix
|
Influenza
|
≤ 0.415 mg (Tween 80)
|
|
Polysorbate 80
|
Surfactant
|
Flucelvax
|
Influenza
|
≤1125 mcg (Tween 80)
|
|
Polysorbate 80
|
Surfactant
|
Gardasil
|
HPV
|
50 mcg
|
|
Polysorbate 80
|
Surfactant
|
Infanrix
|
DTaP
|
≤ 100 mcg (Tween 80)
|
|
Polysorbate 80
|
Surfactant
|
JE-Vax
|
Japanese Encephalitis
|
< 0.0007%
|
|
Polysorbate 80
|
Surfactant
|
Kinrix
|
DTaP+IPV
|
≤ 100 mcg (Tween 80)
|
|
Polysorbate 80
|
Surfactant
|
Pediarix
|
DTaP+HepB+IPV
|
≤ 100 mcg (Tween 80)
|
|
Polysorbate 80
|
Surfactant
|
Pentacel
|
DTaP+IPV+Hib
|
10 ppm
|
|
Polysorbate 80
|
Surfactant
|
Prevnar 13
|
Pneumococcal 13-valent
|
100 mcg
|
|
Polysorbate 80
|
Surfactant
|
RotaTeq
|
Rotavirus
|
Amount not specified in Package Insert
|
|
Porcine DNA
|
Residual Medium
|
Rotarix
|
Rotavirus
|
PCV-1
|
|
Porcine DNA
|
Residual Medium
|
RotaTeq
|
Rotavirus
|
PCV-1 and PCV-2
|
|
Potassium Aluminum Sulfate
|
Adjuvant
|
Comvax
|
Hib+HepB
|
Amount not specified in Package Insert
|
|
Potassium Aluminum Sulfate
|
Adjuvant
|
Recombivax HB
|
HepB
|
Amount not specified in Package Insert
|
|
Potassium Chloride
|
Buffer
|
Afluria
|
Influenza
|
20 mcg
|
|
Potassium Chloride
|
Buffer
|
ProQuad
|
MMRV
|
60 mcg
|
|
Potassium Chloride
|
Medium Nutrient
|
Rotarix
|
Rotavirus
|
in medium
|
|
Potassium Chloride
|
Buffer
|
Varivax
|
Varicella
|
0.08 mg
|
|
Potassium Chloride
|
Buffer
|
Zostavax
|
Varicella Zoster
|
0.10 mg
|
|
Potassium Glutamate
|
Stabilizer
|
RabAvert
|
Rabies
|
1 mg
|
|
Protamine Sulfate
|
Protein Purifier
|
Ixiaro
|
Japanese Encephalitis
|
≤ 1 mcg/mL
|
|
Salts
|
Adjust tonicity
|
Pneumovax 23
|
Pneumococcal 23-valent
|
Amount not specified in Package Insert
|
|
Salts and Sugars, Inorganic
|
Medium Nutrient
|
BioThrax
|
Anthrax
|
Amount not specified in Package Insert
|
|
Salts, Inorganic
|
Medium Nutrient
|
Twinrix
|
HepA+HepB
|
Sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
ACAM2000
|
Smallpox
|
0.5-0.7% (sodium chloride)
|
|
Salts, Mineral
|
Adjust tonicity
|
ActHIB
|
Hib
|
0.4% sodium chloride in diluent
|
|
Salts, Mineral
|
Adjust tonicity
|
Afluria
|
Influenza
|
4.1 mg sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
BioThrax
|
Anthrax
|
0.85% sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
Boostrix
|
Tdap
|
4.5 mg sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
Cervarix
|
HPV
|
4.4 mg sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
Comvax
|
Hib+HepB
|
0.9% sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
Engerix-B
|
HepB
|
9 mg/mL sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
Flublok
|
Influenza
|
4.4 mg sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
Gardasil
|
HPV
|
9.56 mg sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
Hiberix
|
Hib
|
0.9% sodium chloride in diluent
|
|
Salts, Mineral
|
Adjust tonicity
|
Infanrix
|
DTaP
|
4.5 mg sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
Kinrix
|
DTaP+IPV
|
4.5 mg sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
Menhibrix
|
Meningococcal CY+Hib
|
0.9% sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
MMR-II
|
MMR
|
sodium chloride
|
|
Salts, Mineral
|
Adjust tonicity
|
Pediarix
|
DTaP+HepB+IPV
|
|