Priorix-Tetra

/ GSK

Children from 12 months up to 12 years: Infants and children aged from 12 months up to 12 years should receive two doses (each of 0.5 ml) of vaccine. The age at which infants or children may receive this vaccine should reflect applicable official recommendations*, which vary according to the epidemiology of these diseases. The dose interval should preferably* be between 6 weeks and 3 months. When the first dose is administered at 11 months of age, the second dose should be administered within 3 months. Under no circumstances should the dose interval be less than 4 weeks. Alternatively, and in accordance with applicable official recommendations*:
A single dose may be administered to children who have already received a single dose of another measles, mumps and rubella (MMR) vaccine and/or a single dose of another varicella vaccine.
A single dose may be administered followed by a single dose of another measles, mumps and rubella (MMR) vaccine and/or a single dose of another varicella vaccine.
Applicable official recommendations may vary regarding the interval between doses and the need for two or one doses of measles, mumps and rubella and of varicella-containing vaccines.
Method of administration: The vaccine is to be injected by the subcutaneous route in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.
For instructions on reconstitution of the medicinal product before administration- See prescribing information for full details.

Active immunisation against measles, mumps, rubella and varicella in children from the age of 12 months up and including 12 years of age.  Note: The use of this vaccine should be based on official recommendations.

* As with other vaccines, the administration of the vaccine should be postponed in subjects suffering from acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
* Hypersensitivity to the active substances or to any of the excipients or neomycin. A history of contact dermatitis to neomycin is not a contra-indication. For egg allergy.
* Hypersensitivity after previous administration of measles, mumps, rubella and/or varicella vaccines.
* Current or recent immunosuppressive therapy (including high doses of corticosteroids). It is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e.g. for asthma prophylaxis or replacement therapy)
* Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15%.
* Pregnancy. Furthermore, pregnancy should be avoided for 1 month following vaccination.

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. Patients with rare hereditary problems of fructose intolerance should not take this vaccine. Salicylates should be avoided for 6 weeks after each vaccination with this vaccine 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 observed as compared to concomitant administration of MMR and varicella vaccines. 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). 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 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. Due to the potential risk of decreased vaccine response and/or disseminated diseases, consideration should be given to the time interval between vaccination and immunosuppressive therapy
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 vaccine virus has been shown to occur at a very low rate in seronegative contacts of vaccinees with rash. Transmission of the Oka 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. 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. This vaccine 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 this vaccine be carefully evaluated. 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 this vaccine. 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.
Encephalitis: Encephalitis has been reported during post-marketing use of live attenuated measles, mumps, rubella and varicella vaccines. In a few cases fatal outcomes have been observed, especially in patients who were immunocompromised. Vaccinees/parents should be instructed to seek prompt medical attention if they/their child experience, after vaccination, symptoms suggestive of encephalitis such as loss or reduced levels of consciousness, convulsions or ataxia accompanied by fever and headache.

See prescribing information for full details.

Swelling at the injection site, fever, rush.
See prescribing information for full details.

This vaccine can be given simultaneously (but at separate injection sites) with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV).
There are no data to support the use of this vaccine with any other vaccines.
Serological testing: If tuberculin testing has to be done it should be carried out before or simultaneously with vaccination since it has been reported that combined measles, mumps and rubella vaccines may cause a temporary depression of tuberculin skin sensitivity. As this anergy may last up to a maximum of 6 weeks, tuberculin testing should not be performed within that period after vaccination to avoid false negative results.
In subjects who have received human gammaglobulins or a blood transfusion, vaccination should be delayed for at least three months because of the likelihood of vaccine failure due to passively acquired antibodies. Vaccine recipients should avoid use of salicylates for 6 weeks after each vaccination with this vaccine.

Pregnancy: Pregnant women should not be vaccinated with this vaccine.
In a review of more than 3 500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated with a rubella-containing vaccine, no cases of congenital rubella syndrome were reported. Subsequent post-marketing surveillance identified congenital rubella syndrome associated with a rubella vaccine strain (Wistar RA 27/3) following inadvertent vaccination of a pregnant woman with a measles, mumps and rubella vaccine. Foetal damage has not been documented when measles, mumps or varicella vaccines have been given to pregnant women. Pregnancy should be avoided for 1 month following vaccination. Women who intend to become pregnant should be advised to delay.
Lactation: Adequate human data on the use of this vaccine during lactation are not available.

No case of overdose has been reported.

Storage: Store and transport refrigerated (2°C– 8°C). Do not freeze. Store in the original packaging in order to protect from light. For storage conditions after reconstitution of the medicinal product- See prescribing information for full details. After reconstitution, the vaccine should be administered promptly or kept in the refrigerator (2°C–8°C). If it is not used within 24 hours, it should be discarded.