ly for 5 minutes, and the status light is flashing red, take the On-body Injector off of the patient.
DO NOT apply On-body Injector to patient if red error light is on.
DO NOT leave On-body Injector on patient if red error light is on.
In all cases, do not use. Start over with a new Neulasta Onpro kit, and call Amgen at 1-800-772-6436.
If patient reports an On-body Injector leak, they might not have received full dose. Schedule a follow-up appointment, and report the incident to Amgen at 1-800-772-6436.
Neulasta® (pegfilgrastim)
Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
© 2002 to 2015 Amgen Inc. All rights reserved.
www.neulasta.com 1-800-772-6436 (1-800-77-AMGEN)
Issued: 11/2015
v4
Do not expose the On-body Injector for Neulasta to the following environments as the On-body Injector may be damaged and the patient could be injured:
• MRI
• X-ray
• CT-Scan
• Ultrasound
• Oxygen rich environments such as hyperbaric chambers
Symbol Meaning
Do not reuse this On-body Injector. Single-use only
Refer to Instructions for Use
Do not use if packaging is damaged.
Temperature Limitation
Humidity Limitation
Expiration Date (use by date)
Reference/model number
Lot Number
Type BF medical device (protection from electrical shock)
Sterilized by ethylene oxide
Waterproof up to 8 feet for 1 hour
Prescription use only
Not MRI-safe
On-body Injector for Neulasta® (pegfilgrastim)
Neulasta® (pegfilgrastim) Prefilled Syringe
Electromagnetic Compatibility
The information contained in this section (such as separation distances) is, in general, specifically written in regard to the On-body Injector for Neulasta. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment; older equipment may be particularly susceptible to interference.
General Notes:
Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC), and needs to be installed and put into service according to the EMC information provided in this document.
Portable and mobile RF communications equipment can affect medical electrical equipment.
Cables and accessories not specified within the instructions for use are not authorized. Using cables and/or accessories may adversely impact safety, performance, and electromagnetic compatibility (increased emission and decreased immunity).
Care should be taken if the On-body Injector for Neulasta is used adjacent to other electrical equipment; if adjacent use is inevitable, the On-body Injector for Neulasta should be observed to verify normal operation in this setting.
Electromagnetic Emissions
The On-body Injector for Neulasta is intended for use in the electromagnetic environment specified below. The user of the On-body Injector for Neulasta should ensure that it is used in such an environment.
Emissions Compliance according to Electromagnetic environment
RF Emissions (CISPR 11) Group 1 The On-body Injector for Neulasta uses RF energy only for its inte
