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Priorix
Childhood vaccine given at 1 year old.
Intramuscular injection.
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Australia
Europe
USA
Manufactured by GlaxoSmithKline Biologicals
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Measles virus Schwarz strain (live, attenuated)
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Mumps virus RIT 4385 strain derived from the Jeryl Lynn strain (live, attenuated)
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Rubella virus Wistar RA 27/3 strain (live, attenuated)
1 dose (0.5 ml) also contains:
Anhydrous lactose (32 mg) - a milk sugar. People who are specifically "allergic" to lactose (not just lactose intolerant) should not use medications containing lactose, or ask their health care provider prior to use.
Sorbitol (9 mg) - a sugar alcohol with a sweet taste, a naturally occurring sweetener synthetically extracted from glucose.
Amino acids (9 mg) - organic molecules used by all living things to make proteins.
Mannitol (8 mg) - a sugar alcohol used to test for asthma, to reduce intracranial and intraocular pressure, to measure glomerular filtration rate, and to manage pulmonary symptoms associated with cystic fibrosis. Mannitol may also be used for the promotion of diuresis before irreversible renal failure becomes established. (1)
Residuals from the manufacturing process:
Neomycin sulphate (≤25 mcg) - antibiotic class of drugs.
Ovalbumin (≤60 ng) - the major protein component of egg white.
Bovine serum albumin (≤50 ng) - a serum albumin protein derived from cows.
WARNINGS AND PRECAUTIONS
Febrile Seizures
There is a risk of febrile seizure following immunization with PRIORIX.
Thrombocytopenia
Thrombocytopenia and thrombocytopenic purpura have been reported following vaccination with PRIORIX.
Pregnancy
Do not administer PRIORIX to individuals who are pregnant. Pregnancy should be avoided for 1 month following vaccination.
PRIORIX contains the Schwarz strain of live attenuated measles virus, the RIT 4385 strain of live attenuated mumps virus (derived from the Jeryl Lynn strain), both propagated in chick-embryo fibroblasts from embryonated eggs of specific pathogen-free flocks and the Wistar RA 27/3 strain of live attenuated rubella virus propagated in MRC-5 human diploid cells.
Carcinogenesis, Mutagenesis, Impairment of Fertility
PRIORIX has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.
Frequencies per dose are defined and colour coded as follows:
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
Very rare - <1/10,000
Side effects that are not colour coded are of unknown frequency.
Side effects in trials
Side effects postmarketing
Haematologic/ Lymphatic
Anaemia
Lymphadenopathy
Nervous system disorders
Nervousness
Insomnia
Febrile convulsions
Respiratory disorders
Pharyngitis
Bronchitis
Coughing
Respiratory disorder
Other upper respiratory tract infection
Rhinitis
Pneumonia
Laryngitis
Stridor
Gastrointestinal disorders
Diarrhoea
Anorexia
Gastrointestinal disorder
Parotid gland enlargement
Toothache
Vomiting
Enteritis
Gastroenteritis
Stomatitis
Stomatitis aphthous
Skin and appendage
Rash
Dermatitis
Eczema
Pruritis
Herpes simplex
Herpes zoster
Special Senses
Otitis media
Conjunctivitis
General disorders and administration site conditions
Redness at the injection site
Fever ≥ 38°C (rectal) or ≥ 37.5°C (axillary/oral)
Pain and swelling at the injection site
Fever > 39.5°C (rectal) or >39°C (axillary/oral)
Viral infection
Injury
Infection
Allergy
Abnormal crying
Fatigue
Infection bacterial
Infection fungal
Infections and infestation
Meningitis
Measles-like syndrome
Mumps-like syndrome (including orchitis, epididymitis and parotitis)
Blood and lymphatic system disorders
Thrombocytopenia
Thrombocytopenic purpura
Immune system disorders
Anaphylactic reactions
Nervous system disorders
Encephalitis
Cerebellitis
Cerebellitis like symptoms (including transient gait disturbance and transient ataxia)
Guillain Barré syndrome
Transverse myelitis
Peripheral neuritis
Afebrile seizures
Syncope
Vascular disorders
Vasculitis (including Henoch Schonlein purpura and Kawasaki syndrome)
Skin and subcutaneous tissue disorders
Erythema multiforme
Musculoskeletal and connective tissue disorders
Arthralgia
Arthritis
*side effect list is a combination of Priorix Europe, Canada and USA.