Source: Health Products Regulatory Authority (ZA) Revision Year: 2020 Publisher: MSD (Pty) Ltd, 117 16 th Road, Halfway House, 1685, South Africa
OMZYTA is indicated for simultaneous vaccination against measles, mumps and rubella in individuals 12 months of age or older (see section 4.2).
There is some evidence to suggest that infants who are born to mothers who had wild type measles and who are vaccinated at <1 year of age may not develop sustained antibody levels when later revaccinated. The advantage of early protection must be weighed against the chance for failure to respond adequately on re-immunisation.
Infants who are <12 months of age may fail to respond to the measles component of the vaccine due to presence in the circulation of residual measles antibody of maternal origin; the younger the infant, the lower the likelihood of seroconversion. In geographically isolated or other relatively inaccessible populations for whom immunisation programs are logistically difficult, and in population groups in which wild type measles infection may occur in a significant proportion of infants before 15 months of age, it may be desirable to give the vaccine to infants at an earlier age. Infants vaccinated under these conditions at <12 months of age should be revaccinated after reaching 12 to 15 months of age.
The dose for any age is 0,5 mL administered subcutaneously, preferably into the outer aspect of the upper arm.
Individuals first vaccinated at 12 months of age or older should be revaccinated at 4 to 6 years of age since increased risk of exposure typically occurs around primary school entry. Revaccination is intended to seroconvert those who do not respond to the first dose.
Local health authorities may recommend measles vaccination of infants between 6 to 12 months of age in outbreak situations. This population may fail to respond to the components of the vaccine. Safety and effectiveness of mumps and rubella vaccine in infants <12 months of age have not been established. The younger the infant, the lower the likelihood of seroconversion. Such infants should receive a second dose of OMZYTA at 12 to 15 months of age followed by revaccination at 4 to 6 years of age.
Local health authorities may recommend mumps vaccination in a mumps outbreak situation.
Immunisation of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see section 4.4). Vaccinating susceptible post-pubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the foetus and consequent congenital rubella injury.
Women of childbearing age should be advised not to become pregnant for 1 month after vaccination and should be informed of the reasons for this precaution (see section 4.6).
If it is practical and if reliable laboratory services are available, women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. However, with the exception of premarital and prenatal screening, routinely performing serologic tests for all women of childbearing age to determine susceptibility (so that vaccine is given only to proven susceptible women) can be effective but is expensive. Also, 2 visits to the healthcare provider would be necessary – one for screening and one for vaccination. Accordingly, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing – and may be preferable, particularly when costs of serology are high and follow up of identified susceptible women for vaccination is not assured.
Post-pubertal females should be informed of the frequent occurrence of generally selflimited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination (see section 4.8).
It has been found convenient in many instances to vaccinate rubella susceptible women in the immediate postpartum period (see section 4.6).
Previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella vaccine (such as that contained in monovalent rubella vaccine or in OMZYTA) to reduce the risk of exposure of the pregnant woman.
Individuals planning travel abroad, if not immune, can acquire measles, mumps or rubella and import these diseases to their country.Therefore, prior to international travel, individuals known to be susceptible to one or more of these diseases can receive either a monovalent vaccine (measles, mumps or rubella) or a combination vaccine as appropriate. However, OMZYTA is preferred for persons likely to be susceptible to mumps and rubella; and if monovalent measles vaccine is not readily available, travellers should receive OMZYTA regardless of their immune status to mumps or rubella.
Vaccination has been recommended for susceptible individuals in high risk groups such as college students, healthcare workers and military personnel.
Vaccination of individuals exposed to wild type measles may provide some protection if the vaccine can be administered within 72 hours of exposure. If, however, vaccine is given a few days before exposure, substantial protection may be afforded. There is no conclusive evidence that vaccination of individuals recently exposed to wild type mumps or wild type rubella will provide protection.
If the prevention of sporadic measles outbreaks is the sole objective, revaccination with a measles containing vaccine should be considered (see appropriate product package insert). If concern also exists about immune status regarding mumps or rubella, revaccination with appropriate mumps or rubella containing vaccine should be considered after consulting the appropriate product package inserts.
First withdraw the entire volume of diluent into the syringe to be used for reconstitution. Inject all the diluent in the syringe into the vial of lyophilised vaccine and agitate to mix thoroughly. If the lyophilised vaccine cannot be dissolved, discard. Withdraw the entire contents into a syringe and inject the total volume of reconstituted vaccine subcutaneously.
It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of Hepatitis B and other infectious agents from one person to another.
FOR SUBCUTANEOUS ADMINISTRATION. Do not inject intravascularly.
Do not give immune globulin (IG) concurrently with OMZYTA (see section 4.5).
CAUTION: A sterile syringe free of preservatives, antiseptics and detergents should be used for each injection and/or reconstitution of the vaccine because these substances may inactivate the vaccine viruses. A 25 gauge, 5/8" (16 mm) needle is recommended.
To reconstitute the vaccine, use only the diluent supplied since it is free of preservatives or other antiviral substances, which might inactivate the vaccine viruses.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. Before reconstitution, the lyophilised vaccine is a light yellow compact crystalline plug. OMZYTA, when reconstituted, is a clear yellow liquid.
Overdose has been reported rarely and was not associated with any serious adverse events.
2 years.
After reconstitution, the vaccine should be used immediately; however, in-use stability has been demonstrated for 8 hours when refrigerated at 2 to 8°C.
To maintain potency, OMZYTA must be stored between -50°C and +8°C. Use of dry ice may always subject OMZYTA to temperatures colder than -50°C. Protect the vaccine from light, since such exposure may inactivate the viruses.
Before reconstitution, store the lyophilised vaccine in a refrigerator at 2 to 8°C. The diluent may be stored in the refrigerator with the lyophilised vaccine or separately at room temperature. Do not freeze the diluent.
Combination pack containing lyophilised vaccine and diluent together should be stored at 2 to 8°C.
It is recommended that the vaccine be used as soon as possible after reconstitution. Store reconstituted vaccine in the vaccine vial in a dark place at 2 to 8°C and discard if not used within 8 hours.
Keep out of reach of children.
Vial Powder: 3 mL clear Type 1 borosilicate glass vial with a grey stopper (butyl rubber) and a blue plastic cap.
Sterile Diluent Vial: 0,7 mL water for injection in a 3 mL glass vial with grey rubber stopper and dark grey plastic flipoff cap.
Carton: 3 mL vial of OMZYTA and 3 mL vial of DILUENT are packed together in a cardboard carton with the package insert and patient information leaflet.
Pack sizes of 1 or 10 vials.
Not all pack sizes may be marketed.
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