Source: Health Products Regulatory Authority (ZA) Revision Year: 2020 Publisher: MSD (Pty) Ltd, 117 16 th Road, Halfway House, 1685, South Africa
Hypersensitivity to any component of the vaccine, including gelatin.
Do not give OMZYTA to pregnant females; the possible effects of the vaccine on foetal development are unknown at this time. If vaccination of post-pubertal females is undertaken, pregnancy should be avoided for one month following vaccination (see section 4.6).
Anaphylactic or anaphylactoid reactions to neomycin (each dose of reconstituted vaccine contains approximately 25 µg of neomycin).
Any febrile respiratory illness or other active febrile infection.
Active untreated tuberculosis.
Patients receiving immunosuppressive therapy. This contraindication does not apply to patients who are receiving corticosteroids as replacement therapy e.g. for Addison’s disease.
Individuals with blood dyscrasias, leukaemia, lymphomas of any type or other malignant neoplasms affecting the bone marrow or lymphatic systems.
Primary and acquired immunodeficiency states, including patients who are immunosuppressed in association with AIDS or other clinical manifestations of infection with human immunodeficiency viruses; cellular immune deficiencies and hypogammaglobulinemic and dysgammaglobulinemic states. Measles inclusion body encephalitis (MIBE), pneumonitis and death as a direct consequence of disseminated measles vaccine virus infection have been reported in severely immunocompromised individuals inadvertently vaccinated with measles containing vaccine.
Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
Adequate treatment provisions, including epinephrine injection (1:1 000), should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.
Due caution should be employed in administration of OMZYTA to persons with individual or family history of convulsions, a history of cerebral injury or any other condition in which stress due to fever should be avoided. The physician should be alert to the temperature elevation which may occur following vaccination (see section 4.8).
Live measles vaccine and live mumps vaccine are produced in chick embryo cell culture. Persons with a history of anaphylactic, anaphylactoid or other immediate reactions (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension or shock) subsequent to egg ingestion may be at an enhanced risk of immediate type hypersensitivity reactions after receiving vaccines containing traces of chick embryo antigen. The potential risk to benefit ratio should be carefully evaluated before considering vaccination in such cases. Such individuals may be vaccinated with extreme caution, having adequate treatment on hand should a reaction occur.
Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination. In addition, individuals who experienced thrombocytopenia following the first dose of OMZYTA (or its component vaccines) may develop thrombocytopenia with repeat doses. Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed. The potential risk to benefit ratio should be carefully evaluated before considering vaccination in such cases (see section 4.8).
Safety and effectiveness of measles vaccine in infants below the age of 6 months have not been established. Safety and effectiveness of mumps and rubella vaccine in infants <12 months of age have not been established.
Children and young adults who are known to be infected with human immunodeficiency viruses and are not immunosuppressed may be vaccinated. However, the vaccinees who are infected with HIV should be monitored closely for vaccine preventable diseases because immunisation may be less effective than for uninfected persons (see section 4.3).
Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination. There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals. Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk. However, transmission of the rubella vaccine virus to infants via breast milk has been documented (see section 4.6).
There are no reports of transmission of live attenuated measles or mumps viruses from vaccinees to susceptible contacts.
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 test is to be done, it should be administered either any time before, simultaneously with, or at least 4 to 6 weeks after OMZYTA. Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunised with live measles virus vaccine; no studies have been reported to date of the effect of measles virus vaccines on untreated tuberculous children.
As for any vaccine, vaccination with OMZYTA may not result in protection in 100 % of vaccinees.
Administration of immune globulins (IG) concurrently with OMZYTA may interfere with the expected immune response. Vaccination should be deferred for 3 months or longer following administration of immune globulin (human) and blood or plasma transfusions.
OMZYTA should be given one month before or after administration of other live viral vaccines.
OMZYTA has been administered concurrently with live attenuated varicella and inactivated Haemophilus influenzae type b (Hib) conjugate vaccines using separate injection sites and syringes. No impairment of immune response to individually tested vaccine antigens was demonstrated. The type, frequency and severity of adverse experiences observed with OMZYTA were similar to those seen when each vaccine was given alone.
Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concurrently with measles, mumps and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens.
However, other schedules have been used. Data from published studies concerning the simultaneous administration of the entire recommended vaccine series (i.e. DTaP [or DTwP], IPV [or OPV], Hib with or without Hepatitis B vaccine and varicella vaccine), indicate no interference between routinely recommended childhood vaccines (either live, attenuated or killed).
It is not known whether OMZYTA can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, the vaccine should not be administered to pregnant females; furthermore, pregnancy should be avoided for one month following vaccination (see section 4.3).
In an 18-year survey involving over 1 200 pregnant women who received rubella vaccine within 3 months before or after conception (of whom 683 received the Wistar RA 27/3 strain), none of the newborns had abnormalities compatible with congenital rubella syndrome. Additional data from post-marketing reports and published observational studies have not identified abnormalities compatible with congenital rubella syndrome in patients who received OMZYTA.
Mumps infection during the first trimester of pregnancy may increase the rate of spontaneous abortion. Although mumps vaccine virus has been shown to infect the placenta and foetus, there is no evidence that it causes congenital malformations in humans. Reports have indicated that contracting of wild type measles during pregnancy enhances foetal risk. Increased rates of spontaneous abortion, stillbirth, congenital defects and prematurity have been observed subsequent to infection with wild type measles during pregnancy. There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy. However, it would be prudent to assume that the vaccine strain of virus is also capable of inducing adverse foetal effects.
It is not known whether measles or mumps vaccine virus is secreted in human milk. Recent studies have shown that lactating post-partum women immunised with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breastfed infants. In the infants with serological evidence of rubella infection, none exhibited severe disease; however, one exhibited mild clinical illness typical of acquired rubella. Caution should be exercised when OMZYTA is administered to a nursing woman.
No studies on the effects on the ability to drive and use machines have been performed. OMZYTA is expected to have no or negligible influence on ability to drive and use machines.
Adverse reactions are ranked under headings of frequency using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1 000 to <1/100), Frequency not known (frequency cannot be estimated for post-marketing data)
Uncommon: nasopharyngitis, upper respiratory tract infection or viral infection
Frequency not known: aseptic meningitis, atypical measles, epididymitis, orchitis, otitis media, parotitis, rhinitis, subacute sclerosing panencephalitis
Frequency not known: regional lymphadenopathy, thrombocytopenia
Frequency not known: anaphylactoid reaction, anaphylaxis and related phenomenon such as angioneurotic oedema, facial oedema and peripheral oedema
Frequency not known: irritability
Frequency not known: acute disseminated encephalomyelitis (ADEM), afebrile convulsions or seizures, aseptic meningitis, ataxia, dizziness, encephalitis, encephalopathy, febrile convulsion (in children), Guillain-Barre syndrome, headache, Measles inclusion body encephalitis (MIBE), ocular palsies, optic neuritis, paraesthesia, polyneuritis, polyneuropathy, retrobulbar neuritis, transverse myelitis, syncope
Frequency not known: conjunctivitis, retinitis
Frequency not known: nerve deafness
Uncommon: rhinorrhoea
Frequency not known: bronchial spasm, cough, pneumonia, pneumonitis, sore throat
Uncommon: diarrhoea, vomiting
Frequency not known: nausea
Common: rash morbiliform or other rash
Uncommon: urticaria
Frequency not known: panniculitis, purpura, skin induration, Stevens-Johnson syndrome, Henoch-Schönlein purpura, acute haemorrhagic oedema of infancy, pruritus
Frequency not known: arthritis and/or arthralgia (usually transient and rarely chronic), myalgia
Very common: fever ≥38,5°C, injection site erythema, injection site pain and injection site swelling
Common: injection site bruising
Uncommon: injection site rash
Frequency not known: burning and/or stinging of short duration at the injection site, malaise, papillitis, peripheral oedema, swelling, tenderness, vesicles at the injection site, wheal and flare at the injection site
Frequency not known: vasculitis.
Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of infection with wild type rubella and vary in frequency and severity with age and sex, being greatest in adult females and least in pre-pubertal children.
Chronic arthritis has been associated with wild type rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues. Only rarely have vaccine recipients developed chronic joint symptoms.
Following vaccination in children, reactions in joints are uncommon and generally of brief duration. In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (children: 0 to 3%; women: 12 to 20%) and the reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of months or on rare occasions for years. In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and adult women. Even in older women (35 to 45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
There have been reports of SSPE in children who did not have a history of infection with wild type measles but did receive measles vaccine. Some of these cases may have resulted from unrecognised measles in the first year of life or possibly from the measles vaccination. Based on estimated nationwide measles vaccine distribution, the association of SSPE cases to measles vaccination is about one case per million vaccine doses distributed. This is far less than the association with infection with wild type measles, 6 to 22 cases of SSPE per million cases of measles. The results of a retrospective casecontrolled study conducted by the Centres for Disease Control and Prevention suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE.
Cases of aseptic meningitis have been reported following measles, mumps and rubella vaccination. Although a causal relationship between the Urabe strain of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn mumps vaccine to aseptic meningitis.
Encephalitis/encephalopathy have been reported approximately once for every 3 million doses of the measles, mumps and rubella vaccine manufactured by Merck & Co., Inc. Since 1978, post-marketing surveillance indicates that serious adverse events such as encephalitis and encephalopathy continue to be rarely reported. The risk of such serious neurological disorders following live measles virus vaccine administration remains far less than that for encephalitis and encephalopathy with wild type measles (one per one thousand reported cases).
In severely immunocompromised individuals inadvertently vaccinated with measlescontaining vaccine, measles inclusion body encephalitis, pneumonitis and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported (see section 4.3); disseminated mumps and rubella vaccine virus infection have also been reported.
Panniculitis has been reported rarely following administration of measles vaccine.
In the absence of compatibility studies, the vaccine must not be mixed with other medicinal products.
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