TRIMOVAX
CONTENTS
Live attenuated measles, mumps and rubella virus.
PRESENTATION
Vial (freeze-dried powd for susp for inj) 1 dose + syringe 0.5 mL (diluent).
DESCRIPTION
Each dose of vaccine contains measles virus (Schwarz strain) cultivated on primary culture of chicken embryo cells at least 1000 CCID50, mumps virus (Urabe AM-9 strain) cultivated in embryonated hen eggs at least 5000 CCID50, rubella virus (Wistar RA 27/3M strain) activated on human diploid cells at least 1000 CCID50. It also contains human albumin for lyophilization and water for injections 0.5 mL as diluent.
*CCID50=TCID50=cell culture infectious dose 50%.
Trimovax is generally a homogenous pellet varying from yellow to pinkish beige.
After reconstitiution with the provided diluent, Trimovax is a clear solution varying from yellow to pinkish yellow.
INDICATIONS
Combined prevention of measles, mumps and rubella, from 12 months of age in children of both sexes.
DOSAGE & ADMINISTRATION
The 1st injection is administered from 12 months of age. A 2nd injection is recommended between 3 and 6 years.
Trimovax should be administered by SC or IM route.
Any reconstituted vaccine should be used immediately.
CONTRAINDICATIONS
History of severe hypersensitivity to any component of Trimovax or following a previous administration of Trimovax or a vaccine containing the same components or constituents (see Warnings).
Intramuscular route should not be administered for individuals with bleeding disorders eg, hemophilia or thrombocytopenia or malignant diseases.
Trimovax should not be administered to anyone with congenital or acquired immune deficiency impairing cellular immunity, including immunosuppressive therapies eg, chemotherapy, high doses of systemic corticosteroids given generally for ³14 days.
Use in pregnancy: As with all live attenuated vaccines, pregnancy constitutes a contraindication.
Immunization of women of childbearing age may only be carried out after checking that the woman is not pregnant. Pregnancy should be avoided 2 months following administration of the vaccine.
WARNINGS
In the case of individuals receiving immunosuppressive treatment, a 3-month delay after the end of the treatment should be observed before vaccine administration.
The immunization of women in childbearing age may be carried out only after checking that the woman is not pregnant (see Use in pregnancy under Contraindications).
Neomycin is used in the manufacturing process of Trimovax. As each dose may contain residual amounts of neomycin (<25 mcg/dose), caution must be exercised when Trimovax is administered to subjects with hypersensitivity to this antibiotic (and other antibiotic of the same class).
As each dose may contain residual amounts of ovalbumine (<1 mcg/dose), caution must be exercised when the vaccine is administered to subjects with true egg allergy.
Generally, vaccination must be postponed in cases of moderate or severe febrile and/or acute disease or severe infections.
Caution must be exercised when the vaccine is administered to subjects with convulsion history.
Recent injection of immunoglobulins (see Interactions).
PRECAUTIONS
Do not inject via the intravascular route.
Avoid contact between the vaccine and disinfectant products used for cleaning the injection site since they may inactivate the vaccine viruses.
As with all injectable vaccines, supervision and adrenaline used for the control of immediate allergic reactions must be available in case of an anaphylactic event following administration of the vaccine.
Use in lactation: Trimovax is not contraindicated in lactation.
ADVERSE REACTIONS
Based on data gathered from Trimovax post-marketing surveillance, the reported reactions are as follows: The adverse events are ranked under headings of frequency, using the following convention: Rare: 0.01% and 0.1%; very rare: 0.01%, including isolated reports.
General Disorder and Administration Site Conditions: Rare: Pain, induration, nodule, local urticaria, febrile reaction (pyrexia).
Skin and Subcutaneous Tissue Disorders: Rare: Lymphadenopathy. Very Rare: Erythematous or maculopapular rash.
Blood and Lymphatic System Disorders: Very Rare: Thrombocytopenic purpura, thrombocytopenia with a risk of haemorrhage in severe cases (1/100,000 doses).
Immune System Disorders: Very Rare: Allergic reaction including urticaria and face oedema.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Rhinopharyngeal and cough.
Nervous System Disorders: Very Rare: Meningitis, meningoencephalitis, febrile convulsion.
Infections and Infestations: Very Rare: Orchitis.
Musculoskeletal and Connective Tissue Disorders: Very Rare: Arthralgia.
INTERACTIONS
In order to avoid neutralization of the attenuated viruses contained in the vaccine, vaccination must generally not be performed within 3 months of injection of human immunoglobulins or blood products containing immunoglobulins eg, blood or plasma.
For the same reason, immunoglobulins should not be administered for 2 weeks following immunization. To prevent the potential risk of interference, a 4-week delay should be observed before and after injection of any live attenuated vaccine.
Tuberculin tests may transiently show false negative results subsequent to vaccination.
STORAGE
Store between 2°C and 8°C. Protect from light.
Shelf-Life: 24 months.