Full Prescribing Info
Special Precautions
Prior to immunisation: It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
As with other vaccines, vaccination with Shingrix should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
As with any vaccine, a protective immune response may not be elicited in all vaccines.
In a post-marketing observational study in individuals aged 65 years or older, an increased risk of Guillain-Barré syndrome (estimated 3 excess cases per million doses administered) was observed during the 42 days following vaccination with Shingrix. Available information is insufficient to determine a causal relationship with Shingrix.
Precautions for use: Do not administer the vaccine intravascularly, intradermally or subcutaneously.
Maladministration via the subcutaneous route may lead to an increase in transient local reactions.
As with other vaccines administered intramuscularly, Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
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.
Effects on Ability to Drive and Use Machines: No studies on the effects of Shingrix on the ability to drive and use machines have been performed.
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