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cnl .....SJNP

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••• NOTE: 11Iis ,..,irllq I.d .....E •••

17

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••• NOTE: ThillJeView........,_,........ ""iM1IIiIlslMMlld.'""a•••d10 the puMic. •••

19

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C.....(C~OticSohdioa) ia 1oDI __Wrial I.-for otic1111. e.trualCI is ....._ tbI tree..of..ditIIaI etit!iI in adult..,....,...OIlIyear_o1cIer,..to....,.le of~·~tI_St9~

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A. IXPIkT'AN!L DJSCU$SION

Aa.,.,..I ·wuhekl~DMI1'S ....,olthe~-.e.a.ua. PotIIIItiII_ NpRIiaa _~

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..~ .

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l

Table 1: Potential Sound-Alike/Look-Alike Names Identified for Cetraxal

Citracal

Citrucel

Trexall

Calcium citrate 200 mg tablets;Calcium citrate and vitamin D caplets315 mg/200 lUiCalcium citrate and vitamin D tablets250 mg/62,5 IU;Calcium citrate, vitamin D, magnesium(and other nutrients) tablets 250 mg/125 1U/80mMethylcellulose2 gram/scoop (tablespoonful) powder;

500 m tabletsMethotrexate sodiumTablets: 5 mg, 7.5 mg, 10 mg, 15 mg

1to 2 tablets or caplets twice a day. LA/SA

Dissolve one scoop in water and drink up to three LA/SAtimes daily.

2 to 4 tablets as needed u to 12 er da .Choriocarcinoma and similar trophoblastic SAdiseases: 15 mg to 30 mg daily for a five-daycourse.Acute lymphoblastic leukemias: Induction ofremission: 3.3 mg/m2 in combination with60 mg/m2 ofprednisone given daily.Maintenance therapy: 2 times weekly in totalweekly doses of30 mg/m2• .

Lymphomas: in Burkitt's tumor, Stages I-II:10 mg to 25 mg/day orally for 4 to 8 days. Stage1lI: combined drug therapy with MTX given indoses of0.625 mg to 2.5 mglkg daily.Mycosis fungoides (cutaneous T cell lymphoma):5 mg to 50 mg once weekly. Twice weekly in dosesranging from 15 mg to 37.5 mg in patients whohave responded poorly to weekly therapy.Psoriasis and rheumatoid arthritis: 7.5 mg to30 mg once a week or 3 consecutive doses at 12hour intervals up to 30 mg/week - given as a courseonce weeki .

*Frequently used, not all-inclusive.**LA (look-alike), SA (sound-alike)

B. PHONETIC ORTHOGRAPHIC COMPUTER ANALYSIS (POCA)

As part of the name similarity assessment, proposed names are evaluated via aphonetic/orthographic algorithm. The proposed proprietary name is converted into its phonemicrepresentation before it runs though the phonetic algorithm. The phonetic search modules returna numeric score to the search engine based on the phonetic similarity to the input text. Likewise,an orthographic algorithm exists which operates in a similar fashion. All names identified byPOCA as having significant phonetic or orthographic similarities to Cetraxal were discussed bythe Expert Panel (EPD).

4

C. PRISCIUPTJON ANALYSIS snJDlIS

l.~

. ThRe w_ ceaductII& wi1hia PDA for .. propoM prop...".... to

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vtaW JCeICIip1ioa theJlldieipea1t iDteqn of l'ia to the......·..Itaft

CttraulO.2% 50....DiIIpeDIII1Ud111 ... to die afIIctecI ..

twice cIaiIy for'.

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.. "..... \ ~.