Land: Indonesien
Sprog: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 DOSIS @ (1 VIAL SERBUK INJEKSI + 1 VIAL LARUTAN INJEKSI @ ...
2022-07-12
ERS_leaMENinj_MA Transfer SBP to GWI (Projecr Rinjani)_circ1_22Nov21 _Page 1 of 11_ MENVEO Powder and solution for injection Meningococcal Group A, C, W135 and Y conjugate vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 mL of the reconstituted vaccine) contains: Each powder vial contains: • Meningococcal group A oligosaccharide_ _ 10 micrograms Conjugated to _Corynebacterium diphtheriae_ CRM 197 protein 16.7 to 33.3 micrograms Each solution vial contains: • Meningococcal group C oligosaccharide_ _ 5 micrograms Conjugated to _Corynebacterium diphtheriae_ CRM 197 protein 7.1 to 12.5 micrograms • Meningococcal group W135 oligosaccharide_ _ _ _ _ _ _ _ 5 micrograms Conjugated to _Corynebacterium diphtheriae_ CRM 197 protein 3.3 to 8.3 micrograms • Meningococcal group Y oligosaccharide_ _ _ _ _ _ _ _ _ _ 5 micrograms Conjugated to _Corynebacterium diphtheriae _CRM 197 protein 5.6 to 10.0 micrograms For a full list of excipients, see section “_List of Excipients_”. PHARMACEUTICAL FORM Powder and solution for solution for injection (powder and solution for injection). The powder is a white to off-white cake. The solution is a colourless clear solution. CLINICAL PARTICULARS INDICATIONS _MENVEO_ is indicated for active immunization of travellers to endemic area in children (from 7 months of age), adolescent and adults at risk of exposure to _Neisseria meningitidis_ serogroup A, C, W135, and Y to prevent invasive disease. The use of this vaccine should be in accordance with official recommendations. DOSAGE AND ADMINISTRATION DOSING IN DIFFERENT POPULATIONS: Vaccine schedule for children from 7 to 23 months of age In unvaccinated children from 7 to 23 months of age, _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. Vaccine schedule for children 2 to 10 years of age _MENVEO _is to be administered intramuscularly as a single dose (0.5 mL) injection. For children 2 th Læs hele dokumentet