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AboutAboutAbout APEXXNARMechanism of actionClinical programmeClinical programmeAPEXXNAR clinical study overviewAPEXXNAR adverse drug reactionsAdministration
Dosage, administration, and storage1
  • To minimise resuspension time, syringes should be stored in the refrigerator horizontally
  • Approved for administration as a single dose
  • Packaged as a pre-filled syringe
Dosage and administration1

For intramuscular administration only 

Preparation1

Do not mix APEXXNAR® with other vaccines/products in the same syringe.

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Steps
1. Resuspend drug product Hold the pre-filled syringe horizontally between the thumb and the forefinger and shake vigorously until the contents of the syringe are a homogeneous white suspension. Do not use the vaccine if it cannot be resuspended.
2. Visual inspection Visually inspect the vaccine for large particulate matter and discolouration prior to administration. Do not use if large particulate matter or discolouration is found. If the vaccine is not a homogenous white suspension, repeat steps 1 and 2.
3. Remove syringe cap Remove the syringe cap from the Luer lock adapter by slowly turning the cap counter clockwise while holding the Luer lock adapter.
4. Attach a sterile needle Attach a needle appropriate for intramuscular administration to the pre-filled syringe by holding the Luer lock adapter and turning the needle clockwise.
Administration1

Apexxnar should be administered intramuscularly, preferably in the deltoid muscle, with care to avoid injection into or near nerves and blood vessels.
 
Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied pre-filled syringe. 

Please refer to the Summary of Product Characteristics for full dosing and administration recommendations.1

Storage and handling1
  • Upon receipt, store refrigerated at 2 °C to 8 °C (36 ºF to 46 ºF)
  • Syringes should be stored in the refrigerator horizontally to minimise the resuspension time
  • Do not freeze. Discard if the vaccine has been frozen. Any unused product or waste material should be disposed of in accordance with local requirements
  • APEXXNAR should be administered as soon as possible after being removed from refrigeration 
  • Stability data indicate that the vaccine is stable for 96 hours when stored at temperatures from 8 °C to 25 °C, or 72 hours when stored at temperatures from 0 °C to 2 °C. At the end of these time periods Apexxnar should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only. 
  • The tip cap and plunger stopper of the pre-filled syringe are not made with natural rubber latex
  • The shelf life for APEXXNAR is 24 months
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 for how to report adverse reactions.Reference:APEXXNAR® Summary of Product Characteristics.
View Summary of Product Characteristics     Apexxnar® Loading

Legal Category: S1A
Further information is available upon request

PP-PNR-IRL-0018 Date of Preparation: August 2022

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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