- Approval Id
- a4a6774abc41eafb
- Drug Name
- SHINGRIX POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 50MCG/0.5ML
- Product Name
- SHINGRIX POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 50MCG/0.5ML
- Approval Number
- SIN16079P
- Approval Date
- 2021-01-12
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>The immunisation schedule for <em>Shingrix</em> should be based on official recommendations.</p>
<p><strong>Posology</strong></p>
<p>The primary vaccination schedule consists of two doses of 0.5 ml each; an initial dose followed by a second dose 2 to 6 months later.</p>
<p>For subjects who are immunodeficient, immunosuppressed or likely to become immunosuppressed due to known 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 <em>Pharmacodynamic Effects</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>The need for booster doses has not been established.</p>
<p><em>Shingrix</em> can be given with the same schedule in individuals previously vaccinated with live attenuated HZ vaccine (see <em>Pharmacodynamic Effects</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Shingrix</em> is not indicated for prevention of primary varicella infection.</p>
<p><strong>Method of administration</strong></p>
<p><em>Shingrix</em> is for intramuscular injection only, preferably in the deltoid muscle.</p>
<p>For instructions on reconstitution of the medicinal product before administration, see <em>Instructions for Use/Handling</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>Indications</strong></p>
<p><em>Shingrix</em> is indicated for the prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in:</p>
<ul>
<li>adults 50 years of age or older;</li>
<li>adults 18 years of age or older at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.</li>
</ul>
<p>The vaccine’s effect on the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.</p>
<p>The use of <em>Shingrix</em> should be based on official recommendations.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Hypersensitivity to the active substances or to any component of the vaccine (see <em>Qualitative and Quantitative Composition</em> and <em>Excipients</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- J07BK
- Atc Item Name
- 水痘带状疱疹疫苗
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
