SHINGRIX

/ GSK

The primary vaccination schedule consists of two doses of 0.5 mL each: an initial dose followed by a second dose 2 months later.
If flexibility in the vaccination schedule is necessary, the second dose can be administered between 2 and 6 months after the first dose.
For subjects who are or might become immunodeficient or immunosuppressed due to disease or therapy, and whom would benefit from a shorter vaccination schedule, the second dose can be given 1 to 2 months after the initial dose.
See prescribing information to full details.

For prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in:
• adults 50 years of age or older;
• adults 18 years of age or older at increased risk of HZ.

Hypersensitivity to the active substances or to any of the excipients

Prior to immunisation
* Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
* Vaccination should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
* The vaccine is for prophylactic use only and is not intended for treatment of established clinical disease.
* Should not be administered intravascularly or intradermally. Subcutaneous administration is not recommended. Maladministration via the subcutaneous route may lead to an increase in transient local reactions.
* Should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these subjects.
* Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.

* There are no safety, immunogenicity or efficacy data to support replacing a dose of Shingrix with a dose of another HZ vaccine.
* This medicinal product contains 0.08 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions.
See prescribing information to full details.

Very common: headache, gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), myalgia, injection site reactions (such as pain, redness, swelling), fatigue, chills, fever.
Common: injection site pruritus, malaise

This vaccine can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23), 13-valent pneumococcal conjugate vaccine (PCV13) reduced antigen diphtheria-tetanus-acellular pertussis vaccine (dTpa), or coronavirus disease 2019 (COVID-19) messenger ribonucleic acid (mRNA) vaccine. The vaccines should be administered at different injection sites.
The vaccines should be administered at different injection sites.
Concomitant administration with other vaccines than those listed above has not been studied.
See prescribing information to full details.

Pregnancy: There are no data from the use of this medical product in pregnant women. As a precautionary measure, it is preferable to avoid the use of this medical product during pregnancy.
Lactation: The effect on breast-fed infants of administration of this medical product to their mothers has not been studied. It is unknown whether this medical product is excreted in human milk.

No case of overdose has been reported.