- Approval Id
- b9c55434b90e6a3e
- Drug Name
- MENVEO POWDER AND SOLUTION FOR SOLUTION FOR INJECTION
- Product Name
- MENVEO POWDER AND SOLUTION FOR SOLUTION FOR INJECTION
- Approval Number
- SIN14083P
- Approval Date
- 2012-01-20
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<ul>
<li><p>Vaccine schedule for children from 2 to 23 months of age</p>
<p><u>Infants initiating vaccination from 2 to 6 months of age</u></p>
<p>First three doses of Menveo, each of 0.5 ml, should be given with an interval of at least 2 months; the fourth dose should be administered during the second year of life (at 12 to 16 months).</p>
<p>Alternatively, when Menveo is given as part of a routine infant immunisation programme or according to a national recommendation, a series consisting of three doses, each of 0.5ml, may be given. The first dose should be administered from the age of 2 months, with a second dose 2 months later. The third dose should be administered as early as possible during the second year of life (see section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>If optimal protection against serogroup A is required (for example, travellers to areas where serogroup A is endemic), a 4-dose schedule should be used (see Section 4.4 Special warnings and precautions for use – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Infants with medical conditions associated with increased risk of invasive meningococcal disease should receive a 4-dose schedule (see Section 4.4 Special warnings and precautions for use – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</p>
<p><u>Unvaccinated children from 7 to 23 months of age,</u><br>
Menveo should be administered as two doses, each as a single dose (0.5 ml), with the second dose administered in the second year of life and at least two months after the first dose.</p></li>
<li><p>Vaccine schedule for children 2 to 10 years of age</p>
<p>Menveo is to be administered as single dose (0.5 ml).</p></li>
<li><p>Vaccine schedule for adolescents and adults (from 11 years of age)</p>
<p>Menveo is to be administered as single dose (0.5 ml).</p></li>
</ul>
<p><u>Booster</u></p>
<p>Menveo may be given as a booster dose in subjects who have previously received primary vaccination with Menveo, other conjugated meningococcal vaccine or meningococcal unconjugated polysaccharide vaccine. The need for and timing of a booster dose in subjects previously vaccinated with Menveo is to be defined based on national recommendations.</p>
<p><u>Elderly</u></p>
<p>There are limited data in individuals aged 56 to 65 and there are no data in individuals aged >65 years.</p>
<p><u>Method of administration</u></p>
<p>Each Menveo dose is to be administered as a single 0.5 ml intramuscular injection, preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle (upper arm) in children, adolescents and adults.</p>
<p>It must not be administered intravascularly, subcutaneously or intradermally.</p>
<p>Separate injection sites must be used if more than one vaccine is being administered at the same time.</p>
<p>For instructions on preparation and reconstitution of the product, see section 6.6 – <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>Menveo is indicated for active immunization of children (from 2 months of age), adolescents and adults at risk of exposure to <em>Neisseria meningitidis</em> groups A, C, W-135 and Y, to prevent invasive disease.</p>
<p>The use of this vaccine should be in accordance with official recommendations.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substances or to any of the excipients of the vaccine, including diphtheria toxoid (CRM<sub>197</sub>), or a life-threatening reaction after previous administration of a vaccine containing similar components (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- J07AH08
- Atc Item Name
- meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
