Comment
Author: Admin | 2025-04-28
This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.STELARA® (ustekinumab)Medical InformationSIMPONI® (subcutaneous golimumab)STELARA® (ustekinumab)TREMFYA® (guselkumab)-->Air Bubble in Prefilled Syringe and Prefilled Syringe-based Injectors-->Summary Please refer to the full PRESCRIBING INFORMATION, MEDICATION GUIDE, and INSTRUCTIONS FOR USE regarding the proper administration technique and instructions for the following prefilled syringe and prefilled syringe-based injection device products:SIMPONI prefilled syringe1 SIMPONI SmartJect® autoinjector1STELARA prefilled syringe2TREMFYA prefilled syringe3 TREMFYA prefilled pen (TREMFYA PEN)3TREMFYA One-Press patient-controlled injector3The SIMPONI prefilled syringe, SIMPONI SmartJect autoinjector, STELARA prefilled syringe, TREMFYA prefilled syringe, TREMFYA prefilled pen (TREMFYA PEN), and TREMFYA One-Press patient-controlled injector are to be injected subcutaneously.1-4It is normal to see an air bubble or bubbles in the prefilled syringe and prefilled syringe-based injection device products.4Air bubble In Prefilled SyringeDue to the requirements of the fill/finish process and mechanical placement of the stopper in the syringe, there is a headspace (also known as void space) in the syringe.4The bubble/void space positioning can vary within the liquid depending on the prefilled syringe or prefilled syringe-based injection device orientation.4 It is normal to see bubble or bubbles in the prefilled syringe or prefilled syringe-based injection device product.41 SIMPONI ARIA (golimumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI+ARIA-pi.pdf 2 STELARA (ustekinumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf 3 TREMFYA (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf 4 Data on File. Technical Memorandum - Air bubble in SIMPONI (subcutaneous golimumab) prefilled syringe, SIMPONI SmartJect autoinjector, STELARA (ustekinumab) prefilled syringe, TREMFYA (guselkumab) prefilled syringe, TREMFYA prefilled pen, and TREMFYA One-Press patient-controlled injector; 2023.
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