Supplementary CALCULATIONS GUIDEFor use with Intrathecal Catheter For use with Prometra® Programmable Pump

CALCULATIONS GUIDE, For use with Prometra® Programmable Pump

Contents

Pump Fluid Volumes Easy Reference ................................................................................................1Catheter Fluid Volumes Easy Reference ..............................................................................................2Constant Values and Terminology .....................................................................................................3Variable Values and Terminology .......................................................................................................4Calculations Easy Reference .............................................................................................................5Calculations ...................................................................................................................................6 Bolus Drug Dose from Manual Bolus Injection/Flushing or Myelography ...........................................6 Catheter Aspiration Volume .........................................................................................................6 Catheter Implanted Volume .........................................................................................................6 Changing Drug Concentration ......................................................................................................7 Refill Syringe Concentration ....................................................................................................7 Bridge Bolus with Aspiration ...................................................................................................8 Bridge Bolus after Manual Bolus Injection/Flushing or Myelography ............................................8 Bridge Bolus without Aspiration ..............................................................................................9

CALCULATIONS GUIDE, For use with Prometra® Programmable Pump

CALCULATIONS GUIDE, For use with Prometra® Programmable Pump Page 1

Pump Fluid Volumes Easy Reference

Pump Fluid Pathway Volume = Drug Metering Volume + T-Stem Volume0.205 mL = 0.137 mL + 0.068 mL

T-Stem Volume: 0.068 mL

Drug Metering Controller Volume: 0.137 mL

0.068 mL

Page 2 CALCULATIONS GUIDE, For use with Prometra® Programmable Pump

Catheter Fluid Volumes Easy Reference

Catheter Fluid Pathway Volume = Catheter Access Chamber Volume + T-Stem Volume0.259 mL = 0.191 mL + 0.068 mL

T-Stem Volume: 0.068 mL

Catheter Access Chamber Volume: 0.191 mL

0.068 mL

0.191 mL

0.191 mL

CALCULATIONS GUIDE, For use with Prometra® Programmable Pump Page 3

Constant Values and Terminology

Term Abbreviation Value Definition

Catheter Access Chamber Volume

Cath Access Vol 0.191 mL The volume in the catheter access chamber beneath the catheter access septum.

Catheter Fluid Pathway Volume

Cath Path Vol 0.259 mL The total volume from the catheter access chamber to the distal end of the pump stem, not including the pump drug metering controller. It includes the catheter access chamber volume and the pump T-stem volume.

Intrathecal Catheter Linear Volume

Cath Linear Vol 0.0026 mL/cm The volume in each centimeter length of the intrathecal catheter.

Maximum Delivery Rate

Max Del Rate 0.02 mL/min The maximum rate of drug delivery.

Pump Drug Metering Controller Vol

Drug Meter Vol 0.137 mL The volume in the pump drug metering controller.

Pump Fluid Pathway Volume

Pump Path Vol 0.205 mL The total volume from the drug refill reservoir to the distal end of the pump stem, not including the catheter. It includes the pump drug metering controller volume and the pump T-stem volume.

Pump T-Stem Volume T-Stem Vol 0.068 mL The volume in the pump T-stem connecting the pump drug metering controller with the catheter.

Reservoir Residual Volume

Res Residual Vol 3 mL The volume in the drug refill reservoir after emptying.

Total Catheter Length Total Cath Length 110 cm The length of the catheter as supplied, before trimming.

Page 4 CALCULATIONS GUIDE, For use with Prometra® Programmable Pump

Variable Values and Terminology

Term Abbreviation Definition

Bridge Bolus Bridge Bolus A transitional dose and duration to ensure that the patient is receiving the new changed drug concentration or solution at the prescribed dose. The bridge bolus takes into consideration the old drug concentration being cleared from the pump and catheter fluid pathway before the new programmed regimen takes over.

Implanted Catheter Length (cm) Impl Cath Length

The length of catheter implanted in patient, after trimming. This is determined by subtracting the length of the trimmed portion of catheter from the total catheter length.

Implanted Catheter Volume (mL) Impl Cath Vol The infusate volume in the implanted catheter. This volume is dependent on the implanted catheter length.

Manual Bolus Injection/Flushing Man Bolus Manual bolus of infusate remaining in the catheter access chamber, pump T-stem and intrathecal catheter. This is done by injection through the catheter access septum.

New Drug Concentration (mg/mL) New Conc The target drug concentration when changing drug concentration during a refill procedure.

Old Drug Concentration (mg/mL) Old Conc The drug concentration of infusate remaining in the implanted pump and catheter. This is the same as the new drug concentration calculated at the previous pump refill procedure.

Refill Syringe Concentration (mg/mL)

Refill Conc The drug concentration required in the refill syringe to achieve the desired patient dose. If changing drug concentration or solution, this needs to consider residual volume of Old Drug Concentration in the pump drug refill reservoir after emptying.

Refill Volume (mL) Refill Vol The volume infused into pump drug refill reservoir during a refill procedure.

Targeted Daily Rate (mg/day) Targ DRate The desired daily dose rate for the patient.

Trimmed Catheter Length (cm) Trimmed Cath Length

The length of catheter trimmed and removed during implant. This must be measured in order to calculate implanted catheter length and volume.

CALCULATIONS GUIDE, For use with Prometra® Programmable Pump Page 5

Calculations Easy Reference

Bolus Drug Dose during Manual Bolus Injection/Flushing or Myelography

Man Bolus Dose (mg) = [Impl Cath Vol (mL) + 0.259 mL] x Old Conc (mg/mL)

Catheter Aspiration Volume

Aspirate Volume (mL) = Implanted Catheter Volume (mL) + 0.259 mL

Catheter Implanted Volume

Impl Cath Length (cm) = 110 cm – Trimmed Cath Length (cm)

Impl Cath Vol (mL) = Impl Cath Length (cm) x 0.0026 mL/cm

Changing Drug ConcentrationRefill Syringe Concentration

Refill Conc (mg/mL) = {[New Conc (mg/mL) – Old Conc (mg/mL)] x CF} + New Conc (mg/mL), where

CF = Reservoir Residual Volume (mL) / Refill Vol (mL)

Bridge Bolus with Aspiration or Manual Bolus Injection Bridge Bolus with AspirationBridge Bolus after Manual Bolus Injection/Flushing or Myelography

Bridge 1 Dose (mg) = [0.068 mL + Impl Cath Vol (mL)] x New Conc (mg/mL)

Bridge 1 Duration (min) = [0.068 mL + Impl Cath Vol (mL)] ÷ 0.02 mL/min

Note: Round up to the next whole number for Bridge 1 duration.

Old Conc Dose (mg) = 0.137 mL x Old Conc (mg/mL)

Bridge 2 Dose (mg) = Old Conc Dose (mg) x New Conc (mg/mL) ÷ Old Conc (mg/mL)

Bridge 2 Duration (hr) = Old Conc Dose (mg) ÷ [Targ DRate (mg/day) ÷ 24 hr/day]

Note: For programmer entry, Bridge 2 duration must be expressed in hh:mm

Bridge Bolus Without Aspiration

Old Conc Dose (mg) = [0.205 mL + Impl Cath Vol (mL)] x Old Conc (mg/mL)

Bridge Dose (mg) = Old Conc Dose (mg) x New Conc (mg/mL) ÷ Old Conc (mg/mL)

Bridge Duration (hr) = Old Conc Dose (mg) ÷ [Targ DRate (mg/day) ÷ 24 hr/day]

Note: For programmer entry, Bridge 2 duration must be expressed in hh:mm

Page 6 CALCULATIONS GUIDE, For use with Prometra® Programmable Pump

CalculationsBolus Drug Dose from Manual Bolus Injection/Flushing or MyelographyIf no aspiration is performed, a manual bolus injection/flushing or myelography delivers the full drug dose remaining in the catheter as well as the catheter fluid pathway. Refer to Catheter Access Instructions for Warnings, Precautions and Adverse Events.

Man Bolus Dose (mg) = [Impl Cath Vol (mL) + Cath Path Vol (mL)] x Old Conc (mg/mL)

ExampleIf the • Impl Cath Vol = 0.156 mL, and• Old Conc= 8 mg/mL,

Then, the Man Bolus Dose (mg) = [Impl Cath Vol (mL) + Cath Path Vol (mL)] x Old Conc (mg/mL) = (0.156 mL + 0.259 mL) x 8 mg/mL = (0.415 mL) x 8 mg/mL Man Bolus Dose = 3.320 mg

Catheter Aspiration VolumeRefer to the patient chart or patient implant card for implanted catheter volume.

Aspirate Volume = Implanted Catheter Volume (mL) + 0.259 mL

ExampleIf the • Impl Cath Vol = 0.156 mL,

Then, the Aspirate Volume (mL) = Implanted Catheter Volume (mL) + 0.259 mL = 0.156 mL + 0.259 mL Aspirate Volume = 0.415 mL

Catheter Implanted Volume Impl Cath Length (cm) = Total Cath Length (cm) – Trimmed Cath Length (cm) Impl Cath Vol (mL) = Impl Cath Length (cm) x Cath Linear Vol (mL/cm)

Example If the • Trimmed Cath Length = 50 cm,

Then the Impl Cath Length (cm) = Total Cath Length (cm) – Trimmed Cath Length (cm) = 110 cm – 50 cm Impl Cath Length = 60 cm,

And the

Impl Cath Vol (mL) = Impl Cath Length (cm) x Cath Linear Vol (mL/cm) = 60 cm x 0.0026 mL/cm Impl Cath Vol = 0.156 mL

CALCULATIONS GUIDE, For use with Prometra® Programmable Pump Page 7

CalculationsChanging Drug ConcentrationWhen changing drug concentration, the following values must be calculated:• Refill Syringe Concentration• Bridge Bolus Dose(s)• Bridge Bolus Duration(s)

Refill Syringe Concentration

A correction factor (CF) must be used to calculate refill syringe concentration to account for the old drug concentration in the residual pump reservoir volume.

CF = Reservoir Residual Volume (mL) / Refill Vol (mL) Refill Conc (mg/mL) = {[New Conc (mg/mL) – Old Conc (mg/mL)] x CF} + New Conc (mg/mL)

ExampleIf the• Refill Vol = 20 mL, and the• New Conc = 12 mg/mL, and the• Old Conc = 8 mg/mL,

Then, CF = Reservoir Residual Volume (mL) / Refill Vol (mL) = 3 mL / 20 mL = 0.15,And, Refill Conc (mg/mL) = {[New Conc (mg/mL) – Old Conc (mg/mL)] x CF} + New Conc (mg/mL) = {(12 mg/mL – 8 mg/mL) x 0.15} + 12 mg/mL = {4 mg/mL} x 0.15 + 12 mg/mL = 0.6 mg/mL + 12 mg/mL Refill Conc = 12.6 mg/mL

Page 8 CALCULATIONS GUIDE, For use with Prometra® Programmable Pump

CalculationsChanging Drug Concentration

Bridge Bolus with AspirationBridge Bolus after Manual Bolus Injection/Flushing or Myelography

A bridge bolus may be performed with or without prior aspiration. A bridge bolus is a transitional dose and duration to ensure that the patient is receiving the new, changed drug concentration or solution at the prescribed dose. The bridge bolus takes into consideration the old drug concentration being cleared from the pump and catheter fluid pathway before the new programmed regimen takes over.

After aspiration or manual bolus injection/flushing or myelography, two bridge boluses are programmed. Bridge 1 Bolus moves the old drug concentration to the tip of the catheter. Bridge 2 Bolus delivers the old drug at the new dosing rate and moves the new concentration to the tip of the catheter.

Bridge 1 Dose (mg) = [T-Stem Vol (mL) + Impl Cath Vol (mL)] x New Conc (mg/mL) Bridge 1 Duration (min) = [T-Stem Vol (mL) + Impl Cath Vol (mL)] ÷ Max Del Rate (mL/min) Note: Round up to the next whole number for Bridge 1 duration. Old Conc Dose (mg) = Drug Meter Vol (mL) x Old Conc (mg/mL) Bridge 2 Dose (mg) = Old Conc Dose (mg) x New Conc (mg/mL) ÷ Old Conc (mg/mL) Bridge 2 Duration (hr) = Old Conc Dose (mg) ÷ [Targ DRate (mg/day) ÷ 24 hr/day]

For programmer entry, duration expressed in hours must be converted to hours:minutes. Bridge 2 Duration (hh:mm) = xx.yy hr = xx (hr):[0.yy (hr) x 60 min/hr] (hh:mm)

ExampleIf the • Old Conc= 8 mg/mL, and the• New Conc= 12 mg/mL, and the• Impl Cath Vol = 0.156 mL, and the• Targ DRate = 6 mg/day,

Then, the Bridge 1 Dose (mg) = [T-Stem Vol (mL) + Impl Cath Vol (mL)] x New Conc (mg/mL) = (0.068 mL + 0.156 mL) x 12 mg/mL = (0.224 mL) x 12 mg/mL Bridge 1 Dose = 2.688 mg,

And the Bridge 1 Duration (min) = [T-Stem Vol (mL) + Impl Cath Vol (mL)] ÷ Max Del Rate (mL/min) = (0.068 mL + 0.156 mL) ÷ 0.02 mL/min = (0.224 mL) ÷ 0.02 mL/min = 11.2 min. Rounding to next whole number gives Bridge 1 Duration = 12 min,

And the Old Conc Dose (mg) = Drug Meter Vol (mL) x Old Conc (mg/mL) = 0.137 mL x 8 mg/mL Old Conc Dose =1.096 mg,

And the Bridge 2 Dose (mg) = Old Conc Dose (mg) x New Conc (mg/mL) ÷ Old Conc (mg/mL) = 1.096 mg x 12 mg/mL ÷ 8 mg/mL Bridge 2 Dose = 1.644 mg

CALCULATIONS GUIDE, For use with Prometra® Programmable Pump Page 9

And the Bridge 2 Duration (hr) = Old Conc Dose (mg) ÷ [Targ DRate (mg/day) ÷ 24 hr/day] = 1.096 mg ÷ (6 mg/day ÷ 24 hr/day) = 1.096 mg ÷ 0.25 mg/hr = 4.384 hr, or Bridge 2 Duration (hh:mm) = 4 : (0.384 hr x 60 min/hr) Bridge 2 Duration = 4:23 hh:mm

Bridge Bolus without Aspiration

A bridge bolus may be performed with or without prior aspiration. A bridge bolus is a transitional dose and duration to ensure that the patient is receiving the new, changed drug concentration or solution at the prescribed dose. The bridge bolus takes into consideration the old drug concentration being cleared from the pump and catheter fluid pathway before the new programmed regimen takes over.

Without aspiration or manual bolus, one bridge bolus is programmed. This one bridge bolus delivers the old drug at the new dosing rate and moves the new concentration to the tip of the catheter.

Old Conc Dose (mg) = [Pump Path Vol (mL) + Impl Cath Vol (mL)] x Old Conc (mg/mL) Bridge Dose (mg) = Old Conc Dose (mg) x New Conc (mg/mL) ÷ Old Conc (mg/mL) Bridge Duration (hr) = Old Conc Dose (mg) ÷ [Targ DRate (mg/day) ÷ 24 hr/day]

For programmer entry, duration expressed in hours must be converted to hours:minutes. Bridge Duration (hh:mm) = xx.yy hr = xx (hr):[0.yy (hr) x 60 min/hr] (hh:mm)

ExampleIf the • Old Conc = 8 mg/mL, and the• New Conc = 12 mg/mL, and the• Impl Cath Vol = 0.156 mL, and the• Targ DRate = 6 mg/day,

Then, the Old Conc Dose (mg) = [Pump Path Vol (mL) + Impl Cath Vol (mL)] x Old Conc (mg/mL) = (0.205 mL + 0.156 mL) x 8 mg/mL = 0.361 mL x 8 mg/mL Old Conc Dose = 2.888 mg,

And the Bridge Dose (mg) = Old Conc Dose (mg) x New Conc (mg/mL) ÷ Old Conc (mg/mL) = 2.888 mg x 12 mg/mL ÷ 8 mg/mL Bridge Dose = 4.332 mg,

And the Bridge Duration (hr) = Old Conc Dose (mg) ÷ [Targ DRate (mg/day) ÷ 24 hr/day] = 2.888 mg ÷ (6 mg/day ÷ 24 hr/day) = 2.888 mg ÷ 0.25 mg/hr = 11.55 hr, or Bridge Duration (hh:mm) = 11:(0.55 hr x 60 min/hr) Bridge Duration = 11:33 hh:mm

CalculationsChanging Drug Concentration

Bridge Bolus with AspirationBridge Bolus after Manual Bolus Injection/Flushing or Myelography

Page 10 CALCULATIONS GUIDE, For use with Prometra® Programmable Pump

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