Vaccine Information: M-M-R II (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

No. 4681 — M-M-R II vaccine is supplied as follows:
(1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4681-00
(2) a box of 10 vials of diluent (package B)

Exposure to light may inactivate the vaccine viruses.

To maintain potency, M-M-R II must be stored between -58°F and +46°F (-50°C to +8°C). Use of dry ice may subject M-M-R II to temperatures colder than -58°F (-50°C).

Before reconstitution, refrigerate the lyophilized vaccine at 36°F to 46°F (2°C to 8°C).

Store accompanying diluent in the refrigerator (36°F to 46°F, 2°C to 8°C) or at room temperature (68°F to 77°F, 20°C to 25°C). Do not freeze the diluent.

Administer M-M-R II vaccine as soon as possible after reconstitution. If not administered immediately, reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from light, for up to 8 hours. Discard reconstituted vaccine if it is not used within 8 hours.

For information regarding the product or questions regarding storage conditions, call 1-800-MERCK-90 (1-800-637-2590).

17 PATIENT COUNSELING INFORMATION

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

Discuss the following with the patient:

  • Provide the required vaccine information to the patient, parent, or guardian.
  • Inform the patient, parent, or guardian of the benefits and risks associated with vaccination.
  • Question the patient, parent, or guardian about reactions to a previous dose of M-M-R II vaccine or other measles-, mumps-, or rubella-containing vaccines.
  • Question females of reproductive potential regarding the possibility of pregnancy. Inform female patients to avoid pregnancy for 1 month following vaccination [see Contraindications (4.5) and Use in Specific Populations (8.1)].
  • Inform the patient, parent, or guardian that vaccination with M-M-R II may not offer 100% protection from measles, mumps, and rubella infection.
  • Instruct patients, parents, or guardians to report any adverse reactions to their health-care provider. The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at https://www.vaers.hhs.gov.

Distributed 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 © 1978-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-v205c-i-2008r010

Patient Information
M-M-R® II (pronounced “em em ar too”)
Measles, Mumps, and Rubella Virus Vaccine Live

This is a summary of information about M-M-R® II. You should read it before you or your child receives the vaccine. If you have any questions about the vaccine after reading this leaflet, you should ask your health care provider. This is a summary only. It does not take the place of talking about M-M-R II with your doctor, nurse, or other health care provider. Only your health care provider can decide if M-M-R II is right for you or your child.

What is M-M-R II and how does it work?

M-M-R II is also known as Measles, Mumps, and Rubella Virus Vaccine Live. It is a live virus vaccine that is given as a shot. This vaccine is usually given to people one year old or older. It is meant to help prevent measles (rubeola), mumps, and rubella (German measles).

M-M-R II contains weakened forms of measles virus, mumps virus, and rubella virus.

M-M-R II works by helping the immune system protect you or your child from getting measles, mumps, or rubella.

M-M-R II may not protect everyone who gets the vaccine. M-M-R II does not treat measles, mumps, or rubella once you or your child has them.

What do I need to know about measles, mumps, and rubella?

Measles is also known as rubeola. It is a serious illness. Measles virus can be passed to others if you have it. Measles can give you a high fever, cough, and a rash. The illness can last for 1 to 2 weeks. In rare cases, it can also cause an infection of the brain. This could lead to seizures, hearing loss, intellectual disability, and even death.

Mumps can also be passed to others. This virus can cause fever and headache. It can also make the glands under your jaw swell and be painful. The illness often lasts for several days. Sometimes, mumps can make the testicles swell and be painful. In some cases, it can cause meningitis, which is a swelling of the coverings of the brain and spinal cord.

Rubella is also known as German measles. It is often a mild illness. Rubella virus can cause a mild fever, swollen glands in the neck, pain and swelling in the joints, and a rash that lasts for a short time. It can be very dangerous if a pregnant woman catches it. Women who catch German measles when they are pregnant can have babies who are stillborn. Also, the babies may be blind or deaf, or have heart disease or intellectual disability.

Who should not get M-M-R II?

Do not get M-M-R II if you or your child:

  • are allergic to any of its ingredients. (This includes gelatin. See the ingredient list at the end of this leaflet.)
  • have a weakened immune system (which includes taking high doses of steroids by mouth or in a shot).
  • have a fever.
  • have active tuberculosis that is not treated.
  • are pregnant or plan to get pregnant within the next month.

What should you tell your health care provider before getting M-M-R II?

Tell your health care provider if you or your child:

  • have or have had any medical problems.
  • have a history of seizures or someone in your family has a history of seizures.
  • have received blood or plasma transfusions or human serum globulin.
  • take any medicines. (This includes non-prescription medicines and dietary supplements.)
  • have any allergies.
  • had an allergic reaction to any other vaccine.
  • have or have had a low blood platelet count.
  • are allergic to eggs.

How is M-M-R II given?

M-M-R II is given as a shot to people one year old or older. The dose of the vaccine is the same for everyone. If your child gets the shot when he or she is one year old or older, a second dose is recommended. Often, the second dose is given right before the child goes to elementary school (4 to 6 years of age), but may be given earlier as long as the second dose is at least one month after the first dose.

If your child is less than one year old when he or she first gets the shot, a second dose should be given when they are 12 to 15 months old. Then, a third shot should be given between 4 and 6 years of age. Your doctor will decide the best time and number of shots by using official recommendations.

If a dose is missed, your health care provider will let you know when you should have it.

What are the possible side effects of M-M-R II?

The most common side effect of vaccination with M-M-R II is pain at the site of the shot for a short time.

Other side effects may include:

  • Fever
  • Rash

Less common side effects may also include:

  • Swelling of the testicles
  • Joint pain and/or swelling

Some side effects are rare but may be serious. You should call your health care provider if you notice any of the following problems:

  • Difficulty breathing, wheezing, hives, or a skin rash may be signs of an allergic reaction
  • Bleeding or bruising under the skin
  • Seizures, a severe headache, a change in behavior or consciousness, or difficulty walking

Other side effects may also occur. Your doctor has a more complete list of side effects for M-M-R II.

Contact your doctor or health care provider if you or your child have any new or unusual symptoms after receiving M-M-R II.

Report the following to your doctor or your child’s doctor:

  • exposure to M-M-R II during pregnancy
  • exposure to M-M-R II during the month before getting pregnant

You may also report any adverse reactions to your doctor or your child’s health care provider or submit a report directly to the Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or you may report online to www.vaers.hhs.gov.

What are the ingredients of M-M-R II?

Active Ingredients: weakened forms of the measles, mumps, and rubella viruses.

Inactive Ingredients: sorbitol, sucrose, hydrolyzed gelatin, recombinant human albumin, fetal bovine serum, other buffer and media ingredients, neomycin.

What else should I know about M-M-R II?

This leaflet summarizes important information about M-M-R II.

If you would like more information, talk to your health care provider or call 1-800-622-4477.

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 © 1978-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

usppi-v205c-i-2006r205

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 06/2020

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Carton

NDC 0006-4681-00

10 Single-dose 0.5-mL vials

MEASLES, MUMPS, AND RUBELLA VIRUS VACCINE LIVE
M-M-R® II

Measles vaccine: More Attenuated Enders’ Strain. Chick cell tissue culture origin.
Mumps vaccine: Jeryl Lynn™ Strain. Chick cell tissue culture origin.
Rubella vaccine: Wistar RA 27/3 Strain. Human diploid cell (WI-38) culture origin.
Contains approximately 25 mcg neomycin per dose.
Contains no preservative.
Rx only

A

PRINCIPAL DISPLAY PANEL -- 0.5 mL Vial Carton
(click image for full-size original)
M-M-R II
measles, mumps, and rubella virus vaccine live injection, powder, lyophilized, for suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4681
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEASLES VIRUS STRAIN ENDERS’ ATTENUATED EDMONSTON LIVE ANTIGEN (MEASLES VIRUS STRAIN ENDERS’ ATTENUATED EDMONSTON LIVE ANTIGEN) MEASLES VIRUS STRAIN ENDERS’ ATTENUATED EDMONSTON LIVE ANTIGEN 1000 [TCID_50] in 0.5 mL
MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN (MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN) MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN 12500 [TCID_50] in 0.5 mL
RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN (RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN) RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN 1000 [TCID_50] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN BOVINE
ALBUMIN HUMAN 0.3 mg in 0.5 mL
GELATIN, UNSPECIFIED 14.5 mg in 0.5 mL
NEOMYCIN 25 ug in 0.5 mL
SODIUM CHLORIDE
SODIUM PHOSPHATE
SORBITOL 14.5 mg in 0.5 mL
SUCROSE 1.9 mg in 0.5 mL
Product Characteristics
Color YELLOW (clear yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4681-00 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4681-01)
1 NDC:0006-4681-01 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4681-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101069 04/21/1971
Labeler — Merck Sharp & Dohme Corp. (001317601)

Revised: 08/2020 Merck Sharp & Dohme Corp.

Page 3 of 3 1 2 3

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.