Irina Lenin. MED_SKM p
`
`(smaller standard deviation).
`also improved is closer to the reference value
`FP2 is 30% lower than in FPI. Dose accuracy is
`Regarding to first tests the Injection force or the
`
`Injection force 8, dose accuracy
`
`in FPI; in FP2 it ends before the dial grip area.
`The winding notch "runs" ink': the Dial Drip area
`
`wider arid higher in FlexPers 2.
`part of the Number Sleeve seem to be slightly
`4 Number Sleeve. The ratchet teeth of the upper
`
`Flex Pen 2
`
`The button is harder to remove fr An the DRS.
`feature to the Dialling Ratcnet Spring (ORS).
`is deeper and has a different "push-fit"
`2. Dose Sutton Mt: The DS of the Flex Pen 2
`
`IFlex Pen 1
`
`r'JFlel'P.fl2 I
`
`Flex Pen 1
`
`and the dose correction torque is lowered.
`slightly different so that the friction is reduced
`the Dose Sutton. The arms of the spring are
`Flex Pen 2 has a different "push..fit" feature to
`3. Dialling_Ratchet SpringiDRS): The DRS of the
`
`dispensing and lowers the dispense f>nrce.
`longer. That reduces friction during
`different The arms are slightly thicker and
`1. Drive Sieeve; The ratchet spring is
`
`Differences in construction
`
`Rex Pen "I vs. Rex Pen 2
`
`Dieing module
`
`ribs inside the Drive Sleeve Nut.
`lower end of the drive sleeve which
`caused by a ratchet spring at the
`Clicks during dispensing will be
`
`the cartridge.
`Bearing and pushes down the bung of
`Lead Screw Nut and the notch of the
`The Lead Screw turns through the
`the Lead Screw inside turns forward.
`Clutch so that the Drive Sleeve with
`Number Sleeve engages with the
`Number Sleeve inside the body. The
`Pushing on the Dose Button turns the
`
`Disoensino dose
`
`ratchet spring
`Dialling
`
`sleeve
`number
`the
`inside
`Teeth
`
`separating plate inside the body.
`of the number sleeve against the
`through the stop of the lower end
`the drive sleeve and additionally
`the lower end of the groove of
`01U stop is implemented through
`be turned inside the body: The
`dose" but the number sleeve will
`Same procedure as "Dialling
`
`Correct a dose
`
`inside the Number Sleeve.
`Ratchet Spring and the teeth
`the upper part of the Dialling
`dialling will be provided by
`The clicking sound for
`
`Dialing mockee
`
`:
`ix, • •:::::•••or ••;;;;;;••••;:f.
`:xi:: •
`
`:: .
`
`• •
`
`kW, *
`
`plate inside the Body.
`Ratchet Spring and a separating
`by the position of the Small
`drive sleeve will be hold in place
`tU stop) The lower part of the
`out of the dose mechanism. (60
`end of the grooves limits the way
`grooves of the Drive Sleeve. The
`with tongues inside moves in the
`thread of the Clutch. The Clutch
`body and inside through the
`outside through the thread of the
`out of the Body, the NS turns
`While turning the Number Sleeve
`
`palling a dose
`
`Pen Body
`
`Cap Cap Clip
`
`•
`
`Sbnitiner•
`
`voision,'
`
`lap• •
`
`:
`
`rts:
`
`v,iov
`
`Button
`Dose
`
`Spring
`Ratchet
`Dialling
`
`••-•
`
`Sleeve
`Number
`
`>Tx'
`
`• 12 plastic components •i• cartridoe
`
`remain in the cartridge
`
`- User cannot dial more units than
`
`cancelled or dispensed
`
`• Audible click with every unit dialled,
`
`without losing drug
`
`^ Can dial-down dose (cancel dose)
`
`Clutch
`
`Nut
`Dose
`Last
`
`Drive Sleeve
`
`Lead Screw
`
`• M•=4;;;'.'?:4 :
`
`000e*WriM.' Of- • •
`
`7.7
`
`Nut
`
`Screw
`Lead
`
`• •
`
`Bearing
`
`Cartridge
`
`Cartridge Holder
`
`• , • kz.•,..1M1 • •
`
`Replace the pen cap
`
`the needle
`cover and unscrew
`Replace the outer
`
`from the skin
`Remove the needle
`
`for S seconds
`all the way in — hold
`Press the dose knob
`
`and insert the needle
`
`correct without loss)
`(user can dial and
`Dial the teguired dose Grasp a fold of skin
`
`ee,
`
`injection
`Deliver
`
`lib
`
`• Variable dose, 9..60 113 in I 1U
`
`increments
`
`to prime the pen
`Press the dose knob
`
`to 21ti
`Turn the dose knob
`
`Inner needle cover
`Remove and discard
`
`and keep it safe
`Remove needle cap
`
`screwing into place
`
`by
`
`Remove per cap
`
`* Accepts 'standard' Type A needles
`
`• Accepts Novo 3m1 cartridges only
`
`• Disposable, manual injection device
`Key points
`
`:
`
`:::: : • ••••iiiitssi..
`
`0
`
`pen
`Prepare
`
`User steps
`
`•Xt.DXfAd
`
`•
`
`FlexPone - Novo Nordisk®
`
`1
`
`SANOFI 2328
`Mylan v. Sanofi
`IPR2018-01679
`IPR2018-01680
`IPR2018-01682
`
`