Vaccine Information: PNEUMOVAX 23 (Page 3 of 3)

15 REFERENCES

  1. Liang KY, Zeger S. Longitudinal data analysis of continuous and discrete responses for pre-post designs. Sankhyā: The Indian Journal of Statistics (Series B) 2000; 62: 134-148.

16 HOW SUPPLIED/STORAGE AND HANDLING

PNEUMOVAX 23 is supplied as follows:

NDC 0006-4943-00 — a box of 10 single-dose vials, color coded with a purple cap and stripe on the vial labels and cartons.

NDC 0006-4837-03 — a box of 10 single-dose, pre-filled Luer-Lok™ syringes with tip caps, color coded with a violet plunger rod and purple stripe on the syringe labels and cartons.

Storage and Handling

  • Store at 2-8°C (36-46°F).
  • All vaccine must be discarded after the expiration date.

The vial stoppers, syringe plunger stopper and syringe tip cap are not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

  • Inform the patient, parent or guardian of the benefits and risks associated with vaccination.
  • Tell the patient, parent or guardian that vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.
  • Provide the patient, parent or guardian with the vaccine information statements required by the National Childhood Vaccine Injury Act of 1986, with each immunization.
  • Instruct the patient, parent or guardian to report any serious adverse reactions to their health care provider who in turn should report such events to the vaccine manufacturer or the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967, or report online at www.vaers.hhs.gov.

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

The trademarks depicted herein are owned by their respective companies.

Copyright © 1986-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-v110-i-2009r043

Patient Information about
PNEUMOVAX® 23 (pronounced “noo-mo-vax 23″)Generic Name: pneumococcal vaccine polyvalent

Read this leaflet before you or your child gets the vaccine called PNEUMOVAX 23. If you have any questions about the vaccine after you read this, you should ask your health care provider. This is a summary only. It does not take the place of talking to your doctor, nurse or other health care provider about the vaccine. Only your health care provider can decide if PNEUMOVAX 23 is right for you or your child.

What is PNEUMOVAX 23?

PNEUMOVAX 23 is a vaccine that is given as a shot. It helps protect you from infection by certain germs or bacteria which are called pneumococcus (pronounced “noo-mo-ca-cus”). PNEUMOVAX 23 is for people 50 years of age and older. It is also for people who are 2 years of age and older if they have certain medical conditions that put them at increased risk for infection.

Illnesses or health problems may allow these germs to spread into the blood, lungs, or brain where they can cause serious diseases such as:

  • An infection in the blood
  • A lung infection (pneumonia) that can also come with an infection in the blood
  • An infection of the coverings of the brain and spinal cord (meningitis).

PNEUMOVAX 23 may not protect everyone who gets it. It will not protect against diseases that are caused by bacteria types that are not in the vaccine.

Who should not get PNEUMOVAX 23?

You should not get this vaccine if you (or your child):

  • are allergic to any of its ingredients
  • had an allergic reaction to PNEUMOVAX 23 in the past
  • are less than 2 years old.

What should I tell my health care provider before getting PNEUMOVAX 23?

Tell your health care provider if you (or your child):

  • are allergic to PNEUMOVAX 23
  • have heart or lung problems
  • have a fever
  • have immune problems or are receiving radiation treatment for chemotherapy
  • are pregnant or breast-feeding

How is PNEUMOVAX 23 given?

Most often, just one shot is given.

If you or your child is in a high-risk group for pneumococcal infection, then your health care provider will decide if it would be helpful to give a second shot of PNEUMOVAX 23 at a later time.

Can PNEUMOVAX 23 be given with other vaccines?

Talk to your health care provider if you plan to get ZOSTAVAX at the same time as PNEUMOVAX 23 because it may be better to get these vaccines at least 4 weeks apart.

Talk to your health care provider if you plan to get PNEUMOVAX 23 at the same time as other vaccines.

What are the possible side effects of PNEUMOVAX 23?

The most common side effects are:

  • pain, warmth, soreness, redness, swelling, and hardening at the injection site
  • headache
  • weakness, feeling tired
  • muscle pain

Tell your health care provider or get emergency help right away if you get any of the following problems after vaccination because these may be signs of an allergic reaction or other serious conditions:

  • difficulty breathing
  • wheezing
  • rash
  • hives

Side effects at the site where you get the shot may be more common and may feel worse after a second shot than after the first shot.

Tell your health care provider if you or your child has a side effect that bothers you or that does not go away.

For a more complete list of side effects, ask your health care provider.

You may also report any side effect to your or your child’s health care provider, or directly to the Vaccine Adverse Event Reporting System (VAERS). You may call the VAERS number 1-800-822-7967 at no charge, or report online to www.vaers.hhs.gov.

What are the ingredients of PNEUMOVAX 23?

Active Ingredients: Bacterial sugars from 23 pneumococcal types: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F
Inactive Ingredients: Phenol (a preservative)

What else should I know about PNEUMOVAX 23?

Some adults and children have problems with leakage of spinal fluid after the skull is cracked or injured or after medical operations and this may increase their risk for pneumococcal infection. PNEUMOVAX 23 may not be able to prevent all of these infections.

The vial stoppers, syringe plunger stopper and syringe tip cap for PNEUMOVAX 23 are not made with natural rubber latex.

This leaflet is a summary of information about PNEUMOVAX 23. If you would like more information, talk to your health care provider. You can also call the Merck National Service Center at 1-800-622-4477.

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 2011-2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 12/2019

usppi-v110-i-1912r040

PRINCIPAL DISPLAY PANEL — 5 Dose Vial Carton

NDC 0006-4739-00

One 5-Dose Vial
(0.5 mL/dose)

Pneumococcal
Vaccine
Polyvalent
PNEUMOVAX® 23

Do not use in children less
than 2 years of age.

Each 0.5-mL dose contains
25 mcg of polysaccharide from
each pneumococcal capsular type.

Contains phenol 0.25% addedas preservative.

FOR SYRINGE USE ONLY

Rx only

PRINCIPAL DISPLAY PANEL -- 5 Dose Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 Dose Vial Carton

NDC 0006-4943-00
10 Single-Dose 0.5-mL Vials

Pneumococcal Vaccine Polyvalent
PNEUMOVAX® 23

Do not use in children less than 2 years of age.

Each 0.5-mL dose contains 25 mcg of polysaccharide from each pneumococcal capsular type.
Contains phenol 0.25% added as preservative.

Rx only FOR SYRINGE USE ONLY

PRINCIPAL DISPLAY PANEL -- 10 Dose Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5-mL Syringes Carton

NDC 0006-4837-03

10 Single-dose 0.5-mL Syringes

Pneumococcal Vaccine Polyvalent
PNEUMOVAX® 23

Do not use in children less than 2 years of age.
Each prefilled syringe contains 25 mcg of polysaccharide from each pneumococcal capsular type.Contains phenol 0.25% added as preservative.

Rx only

PRINCIPAL DISPLAY PANEL -- 0.5-mL Syringes
(click image for full-size original)
PNEUMOVAX 23 pneumococcal vaccine polyvalent injection, solution
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4739
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4739-00 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (0006-4739-01)
1 NDC:0006-4739-01 0.5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0006-4739-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101094 07/07/1983 05/16/2015
PNEUMOVAX 23 pneumococcal vaccine polyvalent injection, solution
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4943
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4943-00 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4943-01)
1 NDC:0006-4943-01 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4943-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101094 07/07/1983
PNEUMOVAX 23 pneumococcal vaccine polyvalent injection, solution
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4837
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4837-03 10 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS (0006-4837-01)
1 NDC:0006-4837-01 0.5 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (0006-4837-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101094 07/21/2014
Labeler — Merck Sharp & Dohme Corp. (001317601)

Revised: 09/2020 Merck Sharp & Dohme Corp.

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