MMR Vaccine package Insert.

 ADVERSE REACTIONS

The following adverse reactions include those identified during clinical trials or reported during post- approval use of M-M-R II vaccine or its individual components.
Body as a Whole

Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability.

Cardiovascular System

Vasculitis.

Digestive System

Pancreatitis; diarrhea; vomiting; parotitis; nausea.

Hematologic and Lymphatic Systems

Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis.

Immune System

Anaphylaxis, anaphylactoid reactions, angioedema (including peripheral or facial edema) and bronchial spasm.
Musculoskeletal System

Arthritis; arthralgia; myalgia.

Nervous System

Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) subacute sclerosing panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM); transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis; polyneuropathy; ocular palsies; paresthesia.

Respiratory System

Pneumonia; pneumonitis; sore throat; cough; rhinitis.

Skin

Stevens-Johnson syndrome; acute hemorrhagic edema of infancy; Henoch-Schönlein purpura; erythema multiforme; urticaria; rash; measles-like rash; pruritus; injection site reactions (pain, erythema, swelling and vesiculation).
Special Senses — Ear

Nerve deafness; otitis media.

Special Senses — Eye

Retinitis; optic neuritis; papillitis; conjunctivitis.

Urogenital System

Epididymitis; orchitis.

7 DRUG INTERACTIONS

7.1 Corticosteroids and Immunosuppressive Drugs

M-M-R II vaccine should not be administered to individuals receiving immunosuppressive therapy, including high dose corticosteroids. Vaccination with M-M-R II vaccine can result in disseminated disease due to measles vaccine in individuals on immunosuppressive drugs [see Contraindications (4.2)].
7.2 Immune Globulins and Transfusions

Administration of immune globulins and other blood products concurrently with M-M-R II vaccine may interfere with the expected immune response {9-11} [see Warnings and Precautions (5.5)]. The ACIP has specific recommendations for intervals between administration of antibody containing products and live virus vaccines.

7.3 Tuberculin Skin Testing

It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin skin test with tuberculin purified protein derivative (PPD) is to be done, it should be administered before, simultaneously with, or at least 4 to 6 weeks after vaccination with M-M-R II vaccine.
7.4 Use with Other Live Viral Vaccines

M-M-R II vaccine can be administered concurrently with other live viral vaccines. If not given concurrently, M-M-R II vaccine should be given one month before or one month after administration of other live viral vaccines to avoid potential for immune interference.

 

 

8 pages

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Measles, Mumps, Rubella and Varicella

24 pages.

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