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For internal use only - not for distribution PillCam ® COLON 2 Regimen Guidelines The following PillCam COLON 2 regimen was used in MA-201, the European PillCam COLON 2 Multicenter Trial. 5-000- 239

For internal use only - not for distribution PillCam ® COLON 2 Regimen Guidelines The following PillCam COLON 2 regimen was used in MA-201, the European

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Page 1: For internal use only - not for distribution PillCam ® COLON 2 Regimen Guidelines The following PillCam COLON 2 regimen was used in MA-201, the European

For internal use only - not for distribution

PillCam® COLON 2 Regimen Guidelines

The following PillCam COLON 2 regimen was used in MA-201, the

European PillCam COLON 2 Multicenter Trial.

5-000-239

Page 2: For internal use only - not for distribution PillCam ® COLON 2 Regimen Guidelines The following PillCam COLON 2 regimen was used in MA-201, the European

PillCam COLON 2 Regimen Day Time Instructions Comments

Day -2 At bedtime4 Senna tablets (12mg)

Improves cleansing

Day -1All day Clear liquid diet Only clear liquids, no solid food

7 pm – 9 pm 2L PEG The 2L+2L PEG split improves cleansing (versus 3L+1L split)

Exam Day

7 am – 8:30 am

2L PEG Wait 45-75 min between morning

PEG and capsule ingestion No drinking is allowed after

morning PEG until 1st boost (with the exception of 1 cup with capsule ingestion) not to delay capsule exit from stomach

9:15 am(45-75 min.

after PEG)Capsule Ingestion*

Boost IUpon SB

detection

30ml NaP diluted in ½ glass of water + 1L water

First boost is given upon SB detection to reduce SB transit time

Approx. 50% of capsules will be excreted after 1st boost

Drink the 1L water within 1 hour

Boost II3 hrs after Boost

I

25ml NaP diluted in ½ glass of water + 1L water

Suppository2 hrs after Boost II

10mg Bisacodyl Suppository

Approx 25% of patients require suppository

In approx 50% of cases, capsule will be excreted after suppository (guaranteeing complete exam)

[*] Use of Domperidone 20mg only if capsule is delayed in stomach >1h (approx. 30% of patients) For internal use only - not for distribution

Page 3: For internal use only - not for distribution PillCam ® COLON 2 Regimen Guidelines The following PillCam COLON 2 regimen was used in MA-201, the European

Pre-treatment

Excretion Cleansing Comments

Pre

-treatm

ent M

eth

ods

High Carb Diet Same Same or betterOnly white pasta/noodles cooked in salt water with no sauce were evaluated

Bisacodyl (day-1) -10% Same Not recommended

Senna (day-2) Same Same or better Recommended

Low Residue Diet Same -10-30 % Not recommended

Simethicone-10%-20%

(high dose, with MgC)

?? Not recommended

For internal use only - not for distribution

Page 4: For internal use only - not for distribution PillCam ® COLON 2 Regimen Guidelines The following PillCam COLON 2 regimen was used in MA-201, the European

Alternative Boosts

Dose Excretion Cleansing Comments

Alte

rnativ

e B

oosts

(NaP S

ubstitu

tes)

PEG1L PEG for 1st boost (drink

within 30 min) and 0.5L PEG for 2nd boost (drink within

15 min)

?? Same Up to a total of 5.5L PEG

MoviPrep2/3L MoviPrep (drink within 15 min) + 1L water for 1st boost and 1/3L MoviPrep (drink all at once) + 0.5L

water for 2nd boost

-10% Same Up to a total of 3L MoviPrep

Mg-Citrate

200ml (12gr) Magnesium Citrate (drink all at once) + 1L water (complete within the next hour) for 1st and

2nd boost

-10% ??Brand names:

Citramag, Citroma

Mg-Citrate -Sodium

Picosulfate

1 sachet Mg-Citrate-Sodium-Picosulfate prepared

according to instruction (drink all at once) + 1.5L

water (complete within the next hour) for 1st and 2nd

boost

-10% SameBrand names:

Citrafleet, Picolax, Piclax, Picoprep

Alternative laxatives should be used for boost only if NaP is unavailable or contraindicated

For internal use only - not for distribution