- Approval Id
- a975de8426436b76
- Drug Name
- PERTAGEN® SUSPENSION FOR INJECTION 0.5 ML/DOSE
- Product Name
- PERTAGEN® SUSPENSION FOR INJECTION 0.5 ML/DOSE
- Approval Number
- SIN16283P
- Approval Date
- 2021-07-23
- Registrant
- NOVEM HEALTHCARE PTE LTD
- Licence Holder
- NOVEM HEALTHCARE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SUSPENSION
- Dosage
- <p><strong>4.2. Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>A single 0.5 mL dose of <strong>Pertagen®</strong> is recommended.</p>
<p><strong>Pertagen®</strong> should be given in accordance with WHO and national recommendations or medical practices for booster vaccination and for maternal immunization in the second and third trimester preferably at least 15 days before the end of pregnancy, for protection of infants against pertussis.</p>
<p><strong>Pertagen®</strong> may be considered as an alternative to acellular pertussis combinations (DTaP or Tdap-based vaccines) for pertussis booster immunization in subjects with known hypersensitivity to tetanus (Arthus-type hypersensitivity reaction) or diphtheria vaccines and in individuals who have received multiple and frequent tetanus or diphtheria vaccine doses.</p>
<p><u>Method of administration</u></p>
<p><strong>Pertagen®</strong> should be administered by intramuscular injection, preferably in the deltoid region.</p>
<p>Shake well before use. Do not use if resuspension does not occur after vigorous shaking or foreign particles or discoloration are observed. Administer the total volume of 0.5 mL intramuscularly (IM) (see Section 4.4 – <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>4.1. Therapeutic indications</strong></p>
<p><strong>Pertagen®</strong> is indicated for active booster immunization against pertussis in individuals from the age of 3 years onwards.</p>
<p><strong>Pertagen®</strong> is indicated for maternal immunization in pregnant women for the prevention of pertussis in infants too young to be vaccinated.</p>
<p><strong>Pertagen®</strong> should be used in accordance with official recommendations for booster vaccination and maternal immunization against pertussis only.</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong></p>
<p>Hypersensitivity to the active substance(s) or to any of the excipients listed in Section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em> or formaldehyde.</p>
<p><strong>Pertagen®</strong> should not be administered to individuals with past experience or signs of:</p>
<ul class="dash">
<li><p>severe allergic reaction or any encephalopathy with unknown origin following administration of pertussis vaccines or to any components of the vaccine,</p></li>
<li><p>neurological disorders, uncontrolled epilepsy or progressive encephalopathy.</p></li>
</ul>
- Atc Code
- J07AJ02
- Atc Item Name
- pertussis, purified antigen
- Pharma Manufacturer Name
- NOVEM HEALTHCARE PTE LTD
