- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
|Live attenuated measles virus1 (Schwarz strain)||not less than 103.0 CCID503|
|Live attenuated mumps virus1 (RIT 4385 strain, derived from Jeryl Lynn strain)||not less than 103.7 CCID503|
|Live attenuated rubella virus2 (Wistar RA 27/3 strain)||not less than 103.0 CCID503|
PosologyThe use of PRIORIX should be based on official recommendations.
Individuals 12 months of age or olderThe dose is 0.5 ml. A second dose should be given according to official recommendations.PRIORIX may be used in individuals who have previously been vaccinated with another monovalent or combined measles, mumps and rubella vaccine.
Infants between 9 and 12 months of ageInfants in their first year of life may not respond sufficiently to the components of the vaccines. In case an epidemiological situation requires vaccinating infants in their first year of life (e.g. outbreak or travel to endemic regions, a second dose of PRIORIX should be given in the second year of life, preferably within three months after the first dose. Under no circumstances should the interval between doses be less than four weeks (see sections 4.4 and 5.1).
Infants less than 9 months of ageThe safety and efficacy of PRIORIX in infants under 9 months of age has not been established.
Method of administrationPRIORIX is for subcutaneous injection, although it can also be given by intramuscular injection (see sections 4.4 and 5.1).The vaccine should preferably be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder (see section 4.4).For instructions on reconstitution of the medicinal product before administration see section 6.6.
ThrombocytopeniaCases 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. MMR-associated thrombocytopenia is rare and generally self-limited. In patients with existing thrombocytopenia or a history of thrombocytopenia after measles, mumps or rubella vaccination the risk-benefit of administering PRIORIX should be carefully evaluated. These patients should be vaccinated with caution and preferably using subcutaneous route.
Immunocompromised patientsVaccination 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 or rubella in case of contact, despite appropriate vaccine administration. These patients should be monitored carefully for signs of measles, parotitis and rubella.
TransmissionTransmission of measles and mumps virus from vaccinees to susceptible contacts has never been documented. Pharyngeal excretion of the rubella and measles 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 these excreted vaccine viruses to susceptible contacts. Transmission of the rubella vaccine virus to infants via breast milk as well as transplacental transmission has been documented without any evidence of clinical disease.
PRIORIX has not been evaluated in fertility studies.
Pregnant women should not be vaccinated with PRIORIX.However, fetal damage has not been documented when measles, mumps or rubella vaccines have been given to pregnant women.Even if a theoretical risk cannot be excluded yet, no cases of congenital rubella syndrome have been reported in more than 3500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated with rubella containing vaccines. Therefore, inadvertent vaccination of unknowingly pregnant women with measles, mumps and rubella containing vaccines should not be a reason for termination of pregnancy.Pregnancy should be avoided for 1 month following vaccination. Women who intend to become pregnant should be advised to delay.
Breast-feedingThere is limited experience with PRIORIX during breast-feeding. Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccines may secrete the virus in breast milk and transmit it to breast-fed infants without evidence of any symptomatic disease. Only in the event the child is confirmed or suspected to be immunodeficient, risks and benefits of vaccinating the mother should be evaluated (see section 4.3).
Summary of the safety profileThe safety profile presented below is based on a total of approximately 12,000 subjects administered PRIORIX in clinical trials.Adverse reactions which might occur following the use of a combined mumps, measles, rubella vaccine correspond to those observed after administration of the monovalent vaccines alone or in combination.In controlled clinical studies, signs and symptoms were actively monitored during a 42-day follow-up period. The vaccinees were also requested to report any clinical events during the study period. The most common adverse reactions following PRIORIX administration were injection site redness and fever ≥38°C (rectal) or ≥37.5°C (axillary/oral).
List of adverse reactionsAdverse reactions reported are listed according to the following frequency:Frequencies are reported as:Very common (≥ 1/10)Common (≥ 1/100 to < 1/10)Uncommon (≥ 1/1,000 to < 1/100)Rare (≥ 1/10,000 to <1/1,000)
Clinical trial data
Infections and infestations:Common: upper respiratory tract infectionUncommon: otitis media
Blood and lymphatic system disorders:Uncommon: lymphadenopathy
Immune system disorders:Rare: allergic reactions
Metabolism and nutrition disorders:Uncommon: anorexia
Psychiatric disorders:Uncommon: nervousness, abnormal crying, insomnia
Nervous system disorders:Rare: febrile convulsions
Eye disorders:Uncommon: conjunctivitis
Respiratory, thoracic and mediastinal disorders:Uncommon: bronchitis, cough
Gastrointestinal disorders:Uncommon: parotid gland enlargement, diarrhoea, vomiting
Skin and subcutaneous tissue disorders:Common: rash
General disorders and administration site conditions:Very common: redness at the injection site, fever ≥38°C (rectal) or ≥37.5°C (axillary/oral)Common: pain and swelling at the injection site, fever >39.5°C (rectal) or >39°C (axillary/oral)In general, the frequency category for adverse reactions was similar for the first and second vaccine doses. The exception to this was pain at the injection site which was Common after the first vaccine dose and Very common after the second vaccine dose.
Post-marketing dataThe following adverse reactions have been identified in rare occasions during post-marketing surveillance. Because they are reported voluntarily from a population of unknown size, a true estimate of frequency cannot be provided.
Infections and infestations:Meningitis, measles-like syndrome, mumps-like syndrome (including orchitis, epididymitis and parotitis)
Blood and lymphatic system disorders:Thrombocytopenia, thrombocytopenic purpura
Immune system disordersAnaphylactic reactions
Nervous system disorders:Encephalitis*, cerebellitis, cerebellitis like symptoms (including transient gait disturbance and transient ataxia), Guillain- Barré syndrome, transverse myelitis, peripheral neuritis
Skin and subcutaneous tissue disorders:Erythema multiforme
Musculoskeletal and connective tissue disorders:Arthralgia, arthritis* Encephalitis has been reported with a frequency below 1 per 10 million doses. The risk of encephalitis following administration of the vaccine is far below the risk of encephalitis caused by natural diseases (measles: 1 in 1000 to 2000 cases; mumps: 2-4 in 1000 cases; rubella: approximately 1 in 6000 cases).Accidental intravascular administration may give rise to severe reactions or even shock. Immediate measures depend on the severity of the reaction (see section 4.4).
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Immune response in children 12 months and olderIn clinical studies in children aged from 12 months to 2 years PRIORIX has been demonstrated to be highly immunogenic.Vaccination with a single dose of PRIORIX induced antibodies against measles in 98.1%, against mumps in 94.4% and against rubella in 100% of previously seronegative vaccinees.Two years after primary vaccination seroconversion rates were 93.4% for measles, 94.4% for mumps and 100% for rubella.Although there are no data available concerning the protective efficacy of PRIORIX, immunogenicity is accepted as an indication of protective efficacy. However, some field studies report that the effectiveness against mumps may be lower than the observed seroconversion rates to mumps.
Immune response in children aged 9 to 10 monthsA clinical trial enrolled 300 healthy children 9 to 10 months of age at the time of first vaccine dose. Of these 147 subjects received PRIORIX and VARILRIX concomitantly. Seroconversion rates for measles, mumps and rubella were 92.6%, 91.5% and 100%, respectively. The seroconversion rates reported following the second dose given 3 months after the first dose were 100% for measles and 99.2% for mumps. Therefore a second dose of PRIORIX should be given within three months to provide optimal immune responses.
Adolescents and adultsThe safety and immunogenicity of PRIORIX in adolescents and adults has not been specifically studied in clinical trials.
Intramuscular route of administrationA limited number of subjects received PRIORIX intramuscularly in clinical trials. The seroconversion rates to the three components were comparable to those seen after subcutaneous administration.
Powder:Amino acidsLactose (anhydrous)MannitolSorbitolSolvent:Water for injections
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