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Formulation	12 years & older, Ready to use	12 years & older, Ready to use	5 to 11 years old, Ready to use	5 to 11 years old, Dilute to use	6 months to 4 years old, Dilute to use
Vial	Multi-dose vial Single-dose vial	Multi-dose vial Single-dose vial	Multi-dose vial Single-dose vial	Multi-dose vial	Multi-dose vial
Vial Cap Color	Grey Omicron XBB.1.5	Grey BA.4-5	Blue Omicron XBB.1.5	Orange BA.4-5	Maroon Omicron XBB.1.5
Summary of Product Characteristics	เอกสารกำกับยา	เอกสารกำกับยา	เอกสารกำกับยา	เอกสารกำกับยา	เอกสารกำกับยา
Dosage	30 mcg of raxtozinameran	15 mcg of tozinameran & 15 mcg of famtozinameran	10 mcg of raxtozinameran	5 mcg of tozinameran & 5 mcg of famtozinameran	3 mcg of raxtozinameran
Dilution	Dilution NOT required	Dilution NOT required	Dilution NOT required	Dilution required	Dilution required
Amount of Diluent Needed per Vial	No dilution	No dilution	No dilution	1.3 mL	2.2 mL
Vial Size	2 mL	2 mL	2 mL	2 mL	2 mL
Doses per Vial	6 doses per vial or 1 dose per vial	6 doses per vial or 1 dose per vial	6 doses per vial or 1 dose per vial	10 doses per vial (after dilution)	10 doses per vial (after dilution)
Injection Volume per Dose	0.3 mL	0.3 mL	0.3 mL	0.2 mL	0.2 mL
Fill Volume per Vial	2.25 mL Or 0.3 mL	2.25 mL Or 0.3 mL	2.25 mL Or 0.3 mL	1.3 mL	0.4 mL
Storage Conditions
Refrigeration Storage Time (2°C to 8°C)	10 weeks	10 weeks	10 weeks	10 weeks	10 weeks
Freezer Storage Time (-25°C to -15°C)	DO NOT STORE	DO NOT STORE	DO NOT STORE	DO NOT STORE	DO NOT STORE
ULT Freezer Storage Time (-90°C to -60°C)	18 months (shelf life)	18 months (shelf life)	12 months (shelf life)	18 months (shelf life)	18 months (shelf life)
Room Temperature (8 °C to 30 °C)	12 hours prior to first puncture (including any thaw time)	12 hours prior to first puncture (including any thaw time)	12 hours prior to first puncture (including any thaw time)	12 hours prior to first puncture (including any thaw time)	12 hours prior to first puncture (including any thaw time)
After First Puncture or Dilution (2 °C to 30 °C)	Discard 12 hours after first puncture	Discard 12 hours after first puncture	Discard 12 hours after first puncture	Discard 12 hours after dilution	Discard 12 hours after dilution
Package Size	10 vials	10 vials	10 vials	10 vials	10 vials

January 2024. PP-CVV-THA-0413

เลขทะเบียนตำรับยา:

1C 8/64 (NBC)

2C 8/66 (NBC)