Novo Nordisk NovoPen 3 PenMate Instruction Manual page 29

NDA 19-938/S-037
Page 29
insulin to leak out of the needle. With a suspension insulin (white and cloudy),
this may change the concentration (strength) of the insulin.
IMPORTANT (cont.)
Do not inject a suspension insulin (white and cloudy) if the rear rubber
•
stopper can be seen in the small inspection window.
Always keep a spare insulin delivery device available in case the NovoPen 3
•
PenMate system you are using is lost or damaged.
Keep NovoPen 3 PenMate, NovoPen 3 PenMate system, NovoPen device,
•
PenFill cartridges, and NovoFine disposable needles out of the reach of
children.
Your NovoPen device, NovoPen 3 PenMate, or NovoPen 3 PenMate system
•
should not be shared with anyone else even if you attach a new NovoFine
needle for each injection.
NovoPen 3 PenMate system is not recommended for blind or visually
•
impaired patients, without the assistance of a sighted individual trained to use
it.
If you use more than one type of insulin in Novo Nordisk 3 mL PenFill
•
cartridge, use a separate NovoPen 3 PenMate system for each type of insulin
to avoid giving an injection with a wrong type of insulin.
The American Diabetes Association recommends that insulin should be self-
•
administered. The proper age for self administration of insulin should be
decided by the adult caregiver.
Use only a new 3 mL PenFill cartridge when loading the NovoPen 3 PenMate
•
system. Never load the NovoPen 3 PenMate system with a partially filled
PenFill cartridge.
The NovoPen 3 PenMate system is designed for use with Novo Nordisk 3 mL
•
PenFill cartridges, NovoFine single-use disposable needles, and NovoPen
devices.
Novo Nordisk is not responsible for any consequences arising from the use of
the NovoPen 3 PenMate with products that are not recommended by Novo
Nordisk.
NNPI submission date: 5/17/05
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