Priorix Special Precautions

As with other vaccines, the administration of Priorix should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contra-indication for vaccination.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they can inactivate the attenuated viruses in the vaccine.
Limited protection against measles may be obtained by vaccination up to 72 hours after exposure to natural measles.
Infants below 12 months of age may not respond sufficiently to the measles component of the vaccine, due to the possible persistence of maternal measles antibodies. This should not preclude the use of the vaccine in younger infants (<12 months) since vaccination may be indicated in some situations such as high-risk areas. In these circumstances revaccination at or after 12 months of age should be considered.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
The measles and mumps components of the vaccine are produced in chick embryo cell culture and may therefore contain traces of egg protein. Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g. generalised urticaria, 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 vaccination, although these types of reactions have been shown to be very rare. Individuals who have experienced anaphylaxis after egg ingestion should be vaccinated with extreme caution, with adequate treatment for anaphylaxis on hand should such a reaction occur.
Priorix should be given with caution to persons with a history or family history of allergic diseases or those with a history or family history of convulsions.
Transmission of measles and mumps virus from vaccinees to susceptible contacts has never been documented. Pharyngeal excretion of the rubella virus is known to occur about 7 to 28 days after vaccination with peak excretion around the 11th day. However, there is no evidence of transmission of this excreted vaccine virus to susceptible contacts.
A limited number of subjects received Priorix intramuscularly. An adequate immune response was obtained for all three components (See Dosage & Administration).
PRIORIX MUST NOT BE ADMINISTERED INTRAVASCULARLY.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Cases of worsening of thrombocytopenia and recurrence of thrombocytopenia in subjects who suffered thrombocytopenia after the first dose have been reported following vaccination with live measles, mumps and rubella vaccines. In such cases, the risk-benefit of immunising with Priorix should be carefully evaluated.
There is limited data on the use of Priorix in immunocompromised subjects, therefore vaccination should be considered with caution and only when, in the opinion of the physician, the benefits outweigh the risks (e.g. asymptomatic HIV subjects).
Immunocompromised subjects who have no contraindication for this vaccination (see Contraindications) may not respond as well as immunocompetent subjects, therefore some of these subjects may acquire measles, mumps or rubella despite appropriate vaccine administration. Immunocompromised subjects should be monitored carefully for signs of measles, mumps and rubella.
Effects on Ability to Drive and Use Machines: Not applicable.