- Approval Id
- 93f07a8abf90a60b
- Drug Name
- VAXNEUVANCE® SUSPENSION FOR INJECTION
- Product Name
- VAXNEUVANCE® SUSPENSION FOR INJECTION
- Approval Number
- SIN16944P
- Approval Date
- 2024-02-07
- 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>
The vaccination schedule for VAXNEUVANCE should be based on official recommendations. The national immunization practice recommendations/guidelines should also be considered.</p>
<p><strong>Dosage</strong><br>
Administer a 0.5 mL dose of VAXNEUVANCE intramuscularly.</p>
<p><strong>Method of Administration</strong><br>
For intramuscular use only. Do not inject intravascularly.</p>
<p>The preferred site for injection is the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in children and adults. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.</p>
<p><strong>2.2 Pediatrics</strong><br>
<em><strong>Routine Vaccination Schedule for Infants and Toddlers</strong></em><br>
<em>4-Dose Regimen (Three-Dose Primary Series Followed by a Toddler Dose)</em><br>
The recommended vaccination regimen consists of 4 doses of VAXNEUVANCE, with the first dose given as early as 6 to 12 weeks of age, with an interval of 4 to 8 weeks between doses in the primary series. The fourth dose should be administered at approximately 11 through 15 months of age and at least 2 months after the third dose.</p>
<p><em>3-Dose Regimen (Two-Dose Primary Series Followed by a Toddler Dose)</em><br>
The alternative vaccination regimen consists of 3 doses of VAXNEUVANCE, with the first dose given as early as 6 weeks of age, and a second dose administered 8 weeks later. The third dose should be administered at approximately 11 through 15 months of age.</p>
<p><em>Preterm Infants</em><br>
Preterm infants (<37 weeks gestation at birth) should receive a 4-dose regimen (three-dose primary series followed by a toddler dose) of VAXNEUVANCE, with the first dose given as early as 6 to 12 weeks of age, with an interval of 4 to 8 weeks between doses in the primary series. The fourth dose should be administered at approximately 11 through 15 months of age and at least 2 months after the third dose. <em>[See Warnings and Precautions (5) and Use in Specific Populations (7.5)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>.]</em></p>
<p><em>Prior Vaccination with Another Pneumococcal Conjugate Vaccine</em><br>
The vaccination regimen can be completed with VAXNEUVANCE if initiated with another pneumococcal conjugate vaccine <em>[see Clinical Studies (10)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><em><strong>Catch-Up Vaccination Schedule for Children 7 Months Through 17 Years of Age</strong></em></p>
<p>For children 7 months through 17 years of age who are pneumococcal vaccine-naïve or not fully vaccinated or completed a dosing regimen with lower-valency pneumococcal conjugate vaccines, the following catch-up schedule should be considered:</p>
<p><em>Infants 7 Through 11 months of age</em><br>
Three doses, with the first two doses given at least 4 weeks apart. The third dose is given after 12 months of age, separated from the second dose by at least 2 months.</p>
<p><em>Children 12 Through 23 months of age</em><br>
Two doses, with an interval of 2 months between doses.</p>
<p><em>Children and adolescents 2 Through 17 years of age</em><br>
One single dose.</p>
<p>If a previous pneumococcal conjugate vaccine was administered, at least 2 months should elapse before receiving VAXNEUVANCE.</p>
<p><strong>2.3 Adults</strong><br>One single dose.</p>
<p><strong>2.4 Special Populations</strong><br>
The dosing schedule in special populations should be guided by official recommendations and may include more than one dose of VAXNEUVANCE <em>[see Use in Specific Populations (7.5)</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>VAXNEUVANCE is a vaccine indicated in infants, children and adolescents from 6 weeks through 17 years of age (prior to the 18<sup>th</sup> birthday) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by <em>Streptococcus pneumoniae</em> serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.</p>
<p>VAXNEUVANCE is indicated in adults 18 years of age and older for active immunization for the prevention of invasive disease and pneumonia caused by <em>Streptococcus pneumoniae</em> serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.</p>
<p>VAXNEUVANCE may not prevent disease caused by <em>S. pneumoniae</em> serotypes that are not contained in the vaccine.</p>
- Contraindications
- <p><strong>4. CONTRAINDICATIONS</strong></p>
<p>VAXNEUVANCE is contraindicated in individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or any diphtheria toxoid-containing vaccine. <em>[See Pharmaceutical Particulars (15.2)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>.]</em></p>
- Atc Code
- J07AL02
- Atc Item Name
- pneumococcus, purified polysaccharides antigen conjugated
- Pharma Manufacturer Name
- MSD PHARMA (SINGAPORE) PTE. LTD.
