vaccine, mmr




Zuellig Pharma
Full Prescribing Info
Live attenuated measles, mumps and rubella vaccine.
Each 0.5-mL dose of the reconstituted vaccine contains Schwarz measles not less than 103 TCID50, RIT 4385 mumps not less than 103.7 TCID50 and Wistar RA 27/3 rubella virus strains not less than 103 TCID50. It also contains the following excipients: Vaccine: Amino acids, lactose, mannitol, neomycin sulphate and sorbitol. Diluent: Water for injection.
Priorix is a lyophilised mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived from Jeryl Lynn strain) and Wistar RA 27/3 rubella strains of viruses, separately obtained by propagation either in chick embryo tissue cultures (mumps and measles) or MRC5 human diploid cells (rubella).
Due to minor variation of its pH, the reconstituted vaccine may vary in colour from clear peach to fuchsia pink without deterioration of the vaccine potency.
Priorix meets the World Health Organisation (WHO) requirements for the manufacture of biological substances and for measles, mumps and rubella vaccines, and combined vaccines (live).
Pharmacology: Pharmacodynamics: In clinical studies, Priorix has been demonstrated to be highly immunogenic. Antibodies against measles were detected in 98%, against mumps in 96.1% and against rubella in 99.3% of previously seronegative vaccinees.
In comparative studies, antibodies against measles, mumps and rubella were detected in 98.7%, 95.5% and 99.5% of previously seronegative vaccinees who received Priorix compared to 96.9%, 96.9% and 99.5%, respectively, in the group receiving a commercially available measles, mumps and rubella-combined vaccine.
Subjects followed up to 12 months following vaccination all remained seropositive for antimeasles and antirubella antibodies. 88.4% were still seropositive at month 12 for antimumps antibody. This percentage is in line with what was observed for the commercially available measles, mumps and rubella-combined vaccine (87%).
Pharmacokinetics: Evaluation of pharmacokinetic properties is not required for vaccines.
Toxicology: Preclinical Safety Data: Not applicable.
Active immunisation against measles, mumps and rubella.
Dosage/Direction for Use
Dosage: The 1st dose administration of Priorix is from 9 months of age with a 2nd dose at school age (4-6 years).
Administration: Priorix is for SC injection, although it can also be given by IM injection (see Precautions).
Instructions for Use/Handling: The diluent and reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspects prior to administration. In the event of either being observed, discard the diluent or reconstituted vaccine.
Priorix must be reconstituted by adding the entire contents of the supplied container of diluent to the vial containing the powder. After the addition of the diluent to the powder, the mixture should be well shaken until the powder is completely dissolved in the diluent.
After reconstitution, Priorix should be injected as soon as possible and not later than 8 hrs after reconstitution.
Monodose Presentation: Inject the entire content of the vial, using a new needle for administration.
Multidose Presentation: When using a multidose vial, each dose should be withdrawn using a sterile needle and syringe under strict aseptic conditions; precautions should be taken to avoid contamination of the contents. A new needle should be used to administer each individual dose of the vaccine.
Cases of overdose (up to 2 times the recommended dose) have been reported during post-marketing surveillance. No adverse events have been associated to the overdose.
Subjects with known systemic hypersensitivity to neomycin or to any other component of Priorix. A history of contact dermatitis to neomycin is not a contraindication. For egg allergy, see Precautions.
Subjects with impaired immune responses. These include patients with primary or secondary immunodeficiencies.
However, measles, mumps and rubella-combined vaccines can be given to asymptomatic HIV-infected persons without adverse consequences to their illness and may be considered for those who are symptomatic.
Use in pregnancy: Priorix is contraindicated in pregnant women. Furthermore, pregnancy should be avoided for 3 months after vaccination.
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 contraindication 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 Priorix since they can inactivate the attenuated viruses in the vaccine.
Limited protection against measles may be obtained by vaccination up to 72 hrs after exposure to natural measles.
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 Priorix 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 (eg, 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 7-28 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 IM. An adequate immune response was obtained for all 3 components (see Dosage & Administration).
Priorix should under no circumstances be administered IV.
Cases of worsening of thrombocytopenia and recurrence of thrombocytopenia in subjects who suffered thrombocytopenia after the 1st 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.
Effects on the Ability to Drive or Operate Machinery: Not applicable.
Use in lactation: There are no human data regarding use in breastfeeding women. Persons can be vaccinated where the benefit outweighs the risk.
Use in children: Infants below 12 months 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 Priorix in younger infants (<12 months) since vaccination may be indicated in some situations eg, high-risk areas. In these circumstances, revaccination at or after 12 months of age should be considered.
Use In Pregnancy & Lactation
Use in pregnancy: Priorix is contraindicated in pregnant women. Furthermore, pregnancy should be avoided for 3 months after vaccination.
Use in lactation: There are no human data regarding use in breastfeeding women. Persons can be vaccinated where the benefit outweighs the risk.
Adverse Reactions
Frequencies are reported as: Very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1000 to <1/100; rare: ≥1/10,000 to <1/1000; very rare: <1/10,000.
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 safety profile presented as follows is based on a total of approximately 12,000 subjects administered with Priorix in clinical trials.
Infections and Infestations: Common: Upper respiratory tract infection. Uncommon: 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 1st and 2nd vaccine doses. The exception to this was pain at the injection site which was common after the 1st vaccine dose and very common after the 2nd vaccine dose.
During post-marketing surveillance, the following reactions have been reported additionally in temporal association with Priorix vaccination:
Infections and Infestations: Meningitis.
Blood and Lymphatic System Disorders: Thrombocytopenia, thrombocytopenic purpura.
Immune System Disorders: Anaphylactic reactions.
Nervous System Disorders: Transverse myelitis, Guillain-Barre syndrome, peripheral neuritis, encephalitis [encephalitis has been reported with a frequency <1/10 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 1000-2000 cases; rubella: Approximately 1 in 6000 cases)].
Skin and Subcutaneous Tissue Disorders: Erythema multiforme.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, arthritis.
General Disorders and Administration Site Conditions: Kawasaki syndrome.
In rare cases, a mumps-like condition with an abbreviated incubation period cannot be ruled out. In isolated cases, transient, painful swelling of the testicles has been reported after combined mumps, measles and rubella vaccination.
In rare cases, a measles-like syndrome has been reported following vaccination with Priorix.
Accidental intravascular administration may give rise to severe reactions or even shock. Immediate measures depend on the severity of the reaction (see Precautions).
In comparative studies, a statistically significant lower incidence of local pain, redness and swelling was reported with Priorix compared with the comparator. The incidence of other adverse reactions listed previously was similar in both vaccines.
Drug Interactions
If tuberculin testing has to be done, it should be carried out before or simultaneously with vaccination since it has been reported that live measles (and possibly mumps) vaccine may cause a temporary depression of tuberculin skin sensitivity. This anergy may last for 4-6 weeks and tuberculin testing should not be performed within that period after vaccination to avoid false negative results.
Studies have shown that Priorix can be administered at the same time as the live attenuated varicella vaccine (Varilrix) if separate injection sites are used.
Although data on the concomitant administration of Priorix and other vaccines are not yet available, it is generally accepted that measles, mumps and rubella-combined vaccine may be given at the same time as the oral polio vaccine (OPV) or inactivated polio vaccine (IPV), the injectable trivalent diphtheria, tetanus and pertussis vaccines (DTPw/DTPa) and Haemophilus influenzae type b (Hib) if separate injection sites are used.
If Priorix cannot be given at the same time as other live attenuated vaccines, an interval of at least 1 month should be left between both vaccinations.
In subjects who have received human γ-globulins or a blood transfusion, vaccination should be delayed for at least 3 months because of the likelihood of vaccine failure due to passively acquired mumps, measles and rubella antibodies.
Priorix may be given as a booster dose in subjects who have previously been vaccinated with another measles, mumps and rubella-combined vaccine.
Incompatibilities: Priorix should not be mixed with other vaccines in the same syringe.
Store in a refrigerator between +2°C and +8°C. The diluent can be stored in the refrigerator or at ambient temperature. Do not freeze the lyophilised vaccine nor the diluent. During transport, recommended conditions of storage should be respected, particularly in hot climates.
ATC Classification
J07BD52 - measles, combinations with mumps and rubella, live attenuated ; Belongs to the class of morbilli viral vaccines.
Vial 0.5 mL (lyophilised, whitish to slightly pink powd) x 1's.
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