- Approval Id
- d784be7f02bc1052
- Drug Name
- GARDASIL 9 SUSPENSION FOR INJECTION
- Product Name
- GARDASIL 9 SUSPENSION FOR INJECTION
- Approval Number
- SIN15141P
- Approval Date
- 2016-12-16
- Registrant
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Licence Holder
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SUSPENSION
- Dosage
- <p><strong>2. DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 General</strong><br>
<strong>Dosage</strong><br>
GARDASIL 9 should be administered intramuscularly as 3 separate 0.5-mL doses according to the following schedule:</p>
<p>First dose: at elected date<br>
Second dose: 2 months after the first dose<br>
Third dose: 6 months after the first dose</p>
<p>Individuals are encouraged to adhere to the 0, 2, and 6 months vaccination schedule. However, in clinical studies, efficacy has been demonstrated in individuals who have received all 3 doses within a 1-year period. The second dose should be administered at least 1 month after the first dose, and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.</p>
<p>Alternatively, in individuals 9 through 14 years of age, GARDASIL 9 can be administered according to a 2-dose schedule; the second dose should be administered between 5 and 13 months after the first dose. If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered.</p>
<p>The use of GARDASIL 9 should be in accordance with official recommendations.</p>
<p>It is recommended that individuals who receive a first dose of GARDASIL 9 complete the vaccination course with GARDASIL 9.</p>
<p>The need for a booster dose has not been established. The duration of protection is currently unknown.</p>
<p><strong>Method of Administration</strong><br>
GARDASIL 9 should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.</p>
<p>GARDASIL 9 must not be injected intravascularly. Neither subcutaneous nor intradermal administration has been studied. These methods of administration are not recommended.</p>
<p><strong>2.2 Administration of GARDASIL 9 in Individuals Who Have Been Previously Vaccinated with GARDASIL</strong><br>
Studies using a mixed regimen (interchangeability) of HPV vaccines were not performed for GARDASIL 9.</p>
<p>Safety and immunogenicity of GARDASIL 9 were assessed in individuals who previously completed a three-dose vaccination series with GARDASIL <em>[See 8 ADVERSE REACTIONS and 10 CLINICAL STUDIES</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>1. INDICATIONS AND USAGE</strong></p>
<p>GARDASIL 9 is a vaccine indicated in girls and women from 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, and anal cancer; premalignant genital lesions (cervical, vulvar and vaginal); premalignant anal lesions; HPV infections; cervical adenocarcinoma <em>in situ</em> (AIS); and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58.</p>
<p>GARDASIL 9 is indicated in boys and men from 9 through 45 years of age for the prevention of premalignant lesions and HPV infections caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 and genital warts (condyloma acuminata) caused by HPV types 6 and 11.</p>
- Contraindications
- <p><strong>4. CONTRAINDICATIONS</strong></p>
<p>GARDASIL 9 is contraindicated in patients with hypersensitivity to either GARDASIL 9 or GARDASIL or any of the inactive ingredients in either vaccine.</p>
<p>Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL 9 or GARDASIL should not receive further doses of GARDASIL 9.</p>
- Atc Code
- J07BM03
- Atc Item Name
- papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58)
- Pharma Manufacturer Name
- MSD PHARMA (SINGAPORE) PTE. LTD.
