Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name of the administered product should be clearly recorded. It is recommended to record the batch number as well.

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.

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.

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.

Salicylates should be avoided for 6 weeks after each vaccination with Priorix Tetra as Reye’s Syndrome has been reported following the use of salicylates during natural varicella infection.

Limited protection against measles or varicella may be obtained by vaccination up to 72 hours after exposure to natural disease.

Febrile convulsions
There was an increased risk of fever and febrile convulsions 5 to 12 days after the first dose of Priorix Tetra observed as compared to concomitant administration of MMR and varicella vaccines (see sections 4.8 and 5.1).
Vaccination of subjects with a personal or family history of convulsions (including febrile convulsions) should be considered with caution. For these subjects, alternative immunisation with separate MMR and varicella vaccines should be considered for the first dose (see section 4.2). In any case vaccinees should be monitored for fever during the risk period.
Fever rates are usually high after the first dose of measles-containing vaccines. There was no indication of an increased risk of fever after the second dose.

Immunocompromised patients
Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (e.g. asymptomatic HIV subjects, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases).

Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent subjects, therefore some of these patients may acquire measles, mumps, rubella or varicella in case of contact, despite appropriate vaccine administration.
These patients should be monitored carefully for signs of measles, parotitis, rubella and varicella.

Transmission
Transmission of measles, mumps and rubella viruses from vaccinees to susceptible contacts has never been documented, although pharyngeal excretion of the rubella virus is known to occur about 7 to 28 days after vaccination with peak excretion around the 11th day.
Transmission of the Oka varicella vaccine virus has been shown to occur at a very low rate in seronegative contacts of vaccinees with rash. Transmission of the Oka varicella vaccine virus from a vaccinee who does not develop a rash to seronegative contacts cannot be excluded.
Vaccine recipients, even those who do not develop a varicella-like rash, should attempt to avoid , whenever possible, close association with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination. In circumstances where contact with high-risk individuals susceptible to 
varicella is unavoidable, the potential risk of transmission of the varicella vaccine virus should be weighted against the risk of acquiring and transmitting wild-type varicella virus.
High-risk individuals susceptible to varicella include:
• Immunocompromised individuals (see sections 4.3 and 4.4)
• Pregnant women without documented positive history of varicella (chickenpox) or laboratory evidence of prior infection.
• Newborns of mothers without documented positive history of chickenpox or laboratory evidence of prior infection.


Priorix Tetra should under no circumstances be administered intravascularly or intradermally.
Thrombocytopenia
Cases of worsening of thrombocytopenia and cases of 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 Tetra should be carefully evaluated. These patients should be vaccinated with caution.

Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.

As with any vaccine, a protective immune response may not be elicited in all vaccinees. As for other varicella vaccines, cases of varicella disease have been shown to occur in persons who have previously received Priorix-Tetra. These breakthrough cases are usually mild, with a fewer number of lesions and less fever as compared to cases in unvaccinated individuals.

Very few reports exist on disseminated varicella with internal organ involvement following vaccination with Oka varicella vaccine strain mainly in immunocompromised subjects.
Interference with serological testing (see section 4.5).

Excipients with known effects

Priorix-Tetra contains para-aminobenzoic acid. It may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.
The vaccine contains 583 micrograms of phenylalanine per dose. Phenylalanine may be harmful for individuals with phenylketonuria (PKU).

The vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
The vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.

Effects on Driving

4.7   Effects on ability to drive and use machines

No studies on the effects of Priorix-Tetra on the ability to drive and use machines have been performed. Priorix-Tetra is expected to have no or negligible influence on the ability to drive and use machines.