Vaccine Information: Adenovirus Type 4 and Type 7 Vaccine, Live (Page 3 of 3)

15 REFERENCES

  1. Van den Veyver et al. 1998. Detection of intrauterine viral infection using the polymerase chain reaction. Mol Genet Metab, 63: 85-95
  2. Calvin et al. 2000. Fatal intrauterine adenoviral endomyocarditis with aortic and pulmonary valve stenosis: diagnosis by polymerase chain reaction. Hum Pathol. 31(11):1433-5
  3. Ranucci-Weiss et al. 1998. Intrauterine adenoviral infection associated with fetal non-immune hydrops. Prenat. Diagn. 18(2):182-5
  4. Baschat et al., 2003. Is adenovirus a fetal pathogen? Am J Obstet Gynecol. 189(3):758-63.
  5. Fields Virology, Fifth Edition, 2007, p2409

16 HOW SUPPLIED/STORAGE AND HANDLING

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Enteric Coated Tablets is packaged in a carton of two bottles of 100 tablets of each component of the vaccine:

  • Adenovirus Type 4 Component of Adenovirus Type 4 and Type 7 Vaccine, Live, Oral enteric coated tablet, a white to off-white, round, coated tablet with stylized b and a 4 imprinted on one side, for oral administration NDC 51285-174-02
  • Adenovirus Type 7 Component of Adenovirus Type 4 and Type 7 Vaccine, Live, Oral enteric coated tablet, a light peach, round, coated tablet with stylized b and a 7 imprinted on one side, for oral administration NDC 51285-175-02
  • Supplied as a single carton containing 1 x 100 tablets Adenovirus Type 4 Component and 1 x 100 tablets Adenovirus Type 7 Component NDC 51285-138-50

Store refrigerated between 2° and 8° C (35° and 46° F). Do not freeze. Keep bottle tightly closed and protect from moisture. Do not remove desiccant canister from bottle.

17 PATIENT COUNSELING INFORMATION

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is contraindicated for use in pregnant women.

Inform women to avoid becoming pregnant following vaccination for at least 6 weeks after vaccination to prevent the fetus from being exposed to adenovirus.

Instruct patients to swallow each tablet whole without chewing.

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral contains live virus that is shed in the stool for up to 28 days following vaccination and can cause disease if transmitted. It is given to individuals, undergoing intensive military training, who have limited contact with pregnant women, children under age seven and persons with compromised immune systems. To minimize the risk for transmitting and infecting others with the virus, instruct patients to take the following precautions during the 28-day period following vaccination:

  • Observe proper personal hygiene, such as, frequent hand washing, especially following bowel movements.
  • Caution is advised when in close contact with children less than 7 years of age, immunocompromised individuals (e.g., HIV infected, has cancer, or is receiving cancer treatments) and pregnant women because they may be more vulnerable to infection if exposed to the virus.

If anyone has any questions or concerns regarding this vaccine, they should speak with their healthcare provider.

Manufactured by:
Teva Women’s Health, Inc.
West Chester, PA 19380

Distributed by:
Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054

© 2020 Teva Pharmaceuticals USA, Inc.

Rev. 1/2020

Package/Label Display Panel, Type 4 Component

image
(click image for full-size original)

Adenovirus Type 4 Component of Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Tablets 100s Label Text

NDC 51285-174 -02

Rx only

Adenovirus Type 4 Component

Of Adenovirus Type 4 and

Type 7 Vaccine, Live, Oral

Enteric coated tablets,

For oral administration

NOT TO BE USED ALONE

Take with Adenovirus Type 7 Component

100 tablets

teva

Package/Label Display Panel, Type 7 Component

image
(click image for full-size original)

Adenovirus Type 7 Component of Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Tablets 100s Label Text

NDC 51285-175 -02

Rx only

Adenovirus Type 7 Component

Of Adenovirus Type 4 and

Type 7 Vaccine, Live, Oral

Enteric coated tablets,

For oral administration

NOT TO BE USED ALONE

Take with Adenovirus Type 4 Component

100 tablets

teva

Package/Label Display Panel, Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Kit Carton, Part 1 of 2

image
(click image for full-size original)

Package/Label Display Panel, Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Kit Carton, Part 2 of 2

image
(click image for full-size original)

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Tablets Kit Carton Text

NDC 51285-138-50

Adenovirus Type 4 and Type 7

Vaccine, Live, Oral

Enteric Coated Tablets for Oral Administration

  • 4 7

This vaccine product contains two (2) components.

Package contains:

One bottle of 100 tablets of Adenovirus Type 4 Component and

One bottle of 100 tablets of Adenovirus Type 7 Component

One tablet of Adenovirus Type 4 Component and

one tablet of Adenovirus Type 7 Component are to

be taken at the same time.

Rx only

teva

ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE adenovirus type 4 and type 7 vaccine, live kit
Product Information
Product Type VACCINE Item Code (Source) NDC:51285-138
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51285-138-50 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 100
Part 2 1 BOTTLE 100
Part 1 of 2
ADENOVIRUS TYPE 4 VACCINE, LIVE adenovirus type 4 vaccine, live tablet, coated
Product Information
Item Code (Source) NDC:51285-174
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 (HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578) HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 32000 [TCID_50]
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN
ANHYDROUS LACTOSE
DEXTROSE
FRUCTOSE
MANNOSE, D-
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MONOSODIUM GLUTAMATE
POLACRILIN POTASSIUM
POTASSIUM PHOSPHATE, UNSPECIFIED FORM
SUCROSE
CELLACEFATE
CASTOR OIL
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code b4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51285-174-02 100 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125296 09/16/2011
Part 2 of 2
ADENOVIRUS TYPE 7 VACCINE, LIVE adenovirus type 7 vaccine, live tablet, coated
Product Information
Item Code (Source) NDC:51285-175
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ANTIGEN (HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ANTIGEN) HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ANTIGEN 32000 [TCID_50]
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN
ANHYDROUS LACTOSE
DEXTROSE
FRUCTOSE
MANNOSE, D-
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MONOSODIUM GLUTAMATE
POLACRILIN POTASSIUM
POTASSIUM PHOSPHATE, UNSPECIFIED FORM
SUCROSE
CELLACEFATE
CASTOR OIL
FD&C YELLOW NO. 6
ALUMINUM OXIDE
Product Characteristics
Color ORANGE (light peach) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code b7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51285-175-02 100 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125296 09/16/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125296 09/16/2011
Labeler — Teva Women’s Health, Inc. (017038951)

Revised: 02/2020 Teva Women’s Health, Inc.

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