Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Ceftibuten Sensi-Discs® are intended for use in determining the susceptibility of grampositive and gram-negative bacteria, including Streptococcus peuemoniae (penicillin-susceptible strains only), Streptococcus pyrogens, Haemophilus influenzae, (including ß-lactamase-producing strains) and Moraxella catarrhalis (including B-lactamase-producing strains) species to Ceftibuten. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Schering Corporation, and received FDA approval under NDA Nos. 50-685 and 50-686.

Use of BBL® Ceftibuten Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to defermine the susceptibility of bacteria to Ceftibuten.

Device Description

Ceftibuten Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Ceftibuten supplied by the manufacturer, Schering Corporation, Kenilworth, New Jersey. Each Ceftibuten disc is clearly marked on both sides with the agent and content. Ceftibuten discs are furnished in cartridges of 50 discs each. Ceftibuten cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges.

Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.

Various requlatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A5 (12/93) and M100-S6 (12/95).

Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates for Haemophilus Test Medium Agar for H. influenzae or Mueller Hinton Agar with 5% Sheep Blood for S. pneumoniae] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to those found in the respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A5 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Fifth Edition, Approved Standard", 12/93) and of NCCLS Document M100-S6 ("Performance Standards for Antimicrobial Susceptibility Testing", Sixth Informational Supplement, 12/95).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted to address your requests:

1. Table of Acceptance Criteria and Reported Device Performance

The device is an Antimicrobial Susceptibility Test Disc. Its performance is measured by its ability to accurately determine the susceptibility of bacteria to Ceftibuten, compared to established standards.

Acceptance Criteria (from NCCLS Documents M2-A5 and M100-S6)	Reported Device Performance
*Zone diameter for Haemophilus influenzae* (≥28 mm)**	≥28 mm (Susceptible)
*For Streptococcus pneumoniae* (penicillin-susceptible strains only)**	Susceptible
*Control Organism Limits (MIC range for Haemophilus influenzae* ATCC 49274)**	0.25-1.0 µg/mL
Interpretation: Susceptible (S), Intermediate (I), or Resistant (R) zones sizes must align with NCCLS organism tables.	The provided text states that the zone sizes for interpretation and control organism limits were determined by the antimicrobic manufacturer, Schering Corporation, and received FDA approval. The document refers to NCCLS standards for interpretation. The performance data section directly references the Schering Corporation product insert for CEDAX® (Ceftibuten) as the source of performance data. The interpretation criteria are based on comparing measured zone sizes to established zone size ranges in NCCLS M2-A5 and M100-S6 documents.

2. Sample Size Used for the Test Set and Data Provenance

The provided summary for K965159 does not explicitly state the sample size used for the test set specifically for the Sensi-Disc performance evaluation. It refers to the Schering Corporation product insert for CEDAX® (Ceftibuten) for "Performance Data."

Sample Size for Test Set: Not explicitly stated in the provided document. The Schering product insert, which is referenced, would contain this information.
Data Provenance: The device's zone sizes and control organism limits were determined by the antimicrobic manufacturer, Schering Corporation. This suggests the data is likely prospective, generated during the development and testing of Ceftibuten itself, and subsequently used to establish the Sensi-Disc's performance. The specific country of origin for the data is not specified beyond "Schering Corporation, Kenilworth, New Jersey," which implies United States origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications who established the ground truth for the Sensi-Disc test set. It states that "Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Schering Corporation, and received FDA approval." This implies that the ground truth was established by microbiological experts employed or consulted by Schering Corporation, and later validated by the FDA during the drug's approval process (NDA Nos. 50-685 and 50-686).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The ground truth appears to be established by the manufacturer and validated by the FDA, rather than through a typical multi-reader adjudication process often seen in imaging studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or implied in this document. This type of study focuses on comparing human reader performance with and without AI assistance, which is not relevant for an antimicrobial susceptibility test disc.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the testing of the Ceftibuten Sensi-Disc is inherently a standalone performance evaluation. The device itself (the disc) yields a zone of inhibition, which is then measured and interpreted by a human technician. The "performance data" refers to the accuracy of these zone sizes and their interpretation against established standards (NCCLS documents). There is no "human-in-the-loop" AI or algorithm being evaluated here; it's the performance of the physical diagnostic product.

7. The Type of Ground Truth Used

The ground truth used for this study is based on expert consensus and standardized reference methods. Specifically:

Standardized procedures: The "Bauer-Kirby method," adopted by the National Committee for Clinical Laboratory Standards (NCCLS) and published in their documents (M2-A5 and M100-S6).
Manufacturer-determined and FDA-approved zone sizes: The antimicrobic manufacturer (Schering Corporation) determined the specific zone sizes and control organism limits for Ceftibuten, which were then approved by the FDA as part of the drug's New Drug Applications.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of the Sensi-Disc's development, as it's a diagnostic product rather than an AI/machine learning model that undergoes a distinct training phase.

If we interpret "training set" as the data used to initially establish the interpretation breakpoints for Ceftibuten, this information would reside within the drug's original NDA submission by Schering Corporation. The provided text refers to the "antimicrobic manufacturer, Schering Corporation," having determined these values, but does not give sample sizes.

9. How the Ground Truth for the Training Set Was Established

As above, the concept of a "training set" in the modern AI sense is not directly applicable. However, the ground truth for establishing the interpretive breakpoints (zone sizes for S, I, R) for Ceftibuten was established by:

Extensive microbiological testing: By Schering Corporation during the drug's development. This would involve testing a large number of bacterial isolates with known Minimum Inhibitory Concentrations (MICs) against Ceftibuten.
Correlation with clinical outcomes: These in vitro results (MICs and zone sizes) would have been correlated with clinical efficacy data from human trials to establish clinically relevant breakpoints.
Adherence to standardized methodologies: The testing would have followed established microbiological and pharmaceutical industry standards, likely including methods approved by regulatory bodies like the FDA, and subsequently incorporated into or referenced by NCCLS guidelines.

Summary

{0}------------------------------------------------

K965159

FEB - 4 1997

Date 12/20/96

SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTED BY:

Robert E. James, Director International Regulatory and Quality Development Becton Dickinson Microbiology Systems P.O. Box 243 Cockeysville, MD 21030-0243

NAME OF DEVICE:

Trade Name:	Ceftibuten, 30 mcg, Sensi-Discs Catalog Numbers 4331701, 4331702
Common Name/Description:	Antimicrobial Susceptibility Test Discs
Classification Name:	Antimicrobial Susceptibility Test Discs
PREDICATE DEVICE:	Other BBL® Sensi-Discs® such as Cefixime, 5 mcg, Sensi-Disc®

DEVICE DESCRIPTION:

INTENDED USE:

{1}------------------------------------------------

INDICATIONS FOR USE:

Use of BBL® Ceftibuten Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to defermine the susceptibility of bacteria to Ceftibuten.

PRODUCT DESCRIPTION:

{2}------------------------------------------------

of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A5 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Fifth Edition, Approved Standard", 12/93) and of NCCLS Document M100-S6 ("Performance Standards for Antimicrobial Susceptibility Testing", Sixth Informational Supplement, 12/95).

PERFORMANCE DATA:

See attached Schering Corporation product insert section on Susceptibility testing Diffusion Techniques for CEDAX® (Ceftibuten).

{3}------------------------------------------------

CEDAX

(cettibuten capsules) and I ceftibuten for oral suspension!

FOR ORAL USE ONLY

DESCRIPTION

CEDAX (cettibuten capsules) and icettibuten for oral suspension) contain the active inqredient

iginality. A part has increased weight if there is no copy.
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ed in the consuis formulation include: maps of the comment of the comment of the comments of the comments ont to 400 ing of cellibuten. Inactive ingredients CEDAX Ca of er connectystamine collulose, and BRJAN ST de, and a of Society armosonate, ade-

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21.10

CEDAX CAPSULES

lowing table:

Parameter	Average Plasma Concentration(in µg/mL of celibutenafter a single 400-mg dose)and Derived PharmacokineticParameters (± 1 SD)(n = 12 healthy adult males)	Average Plasma Concentration(in µg/mL of celibutenafter a single 9-mg/kg dose)and Derived PharmacokineticParameters (± 1 SD)(n = 32 pediatric patients)
1.0 h	6.1 (5.1)	9.3 (6.3)
1.5 h	9.9 (5.9)	8.6 (4.4)
2.0 h	11.3 (5.2)	11.2 (4.6)
3.0 h	13.3 (3.0)	9.0 (3.4)
4.0 h	11.2 (2.9)	6.6 (3.1)
6.0 h	5.8 (1.8)	3.8 (2.5)
8.0 h	3.2 (1.0)	1.6 (1.3)
12.0 h	1.1 (0.4)	0.5 (0.4)
Cmax, µg/mL	15.0 (3.3)	13.4 (4.9)
Tmax, h	2.6 (0.9)	2.0 (1.0)
AUC, µg·h/mL	73.7 (16.0)	56.0 (16.9)
T½, h	2.4 (0.2)	2.0 (0.6)
Total body clearance(CL/F) mL/min/kg	1.3 (0.3)	2.9 (0.7)

The aboute beather in Declainc assents are acceptional following sincle oncernal concern concess of CEDAX
Crations of 200 mg and of CEDAX Oral Suspension instrument 1,5 mg/kg Otstri

The women apparent volume of distribution (VF) of cettibuten in 6 adult subtects is 0.21 L/kg
(± 1 SD = 0.03 L/kg).

CEDAX CHAJ:

the first

reture to an a mainer.
Cellibutes is 65% bound to plasma proteins. The protein binding is independent of clasma cattibuten
oncementation,

Bronchial secretions: in a study of 15 adults administered a single 400-mg dose of cefobuten and
scheduled to undergo bronchoscopy, the mean concentrations in epithelial lining huid and bronchial
mucase were 15% and 37%, respectively, of the same concentrations

1199 Presents: In a suover 15 auds annonema a more documents and stransman
science and some and more and comments and more and minutes and ministration
com l'a comments and

comment rational evel. in a study of 30 children accurace 3 mg con control.
coment comments cational nocured 20 children accumstance 9 mg con comments.
Coment computer of Ann Tonsillar assue: Data on celtibuten neneration into tonsitiat tossue are not availab

Tensile assay: Data on catabolism/degradation into tonsillar tissue are not available.

Cerabrospiral tituid: Data on cetubuten penetration into cerebrospinal lium are not available

Metabaliem and Excretion:

In A staby with radiolabed cefubuten administered to 6 healthy adult many of concessured convened to the trans-isomer is approximately a as antimicropia. : Dotent as the cis-

Cettibuten is excreted in the urine: 95% of the administered radioactivity was recovered enner in unne or leces. In 6 heatthy adult mate volunceers. approximately 56% of the administers acse of cettingtien

ant pathway of elimination, battents with renal oversions and oatlents undergoling nemodiation is a summ
cant patients of elimination, battents with renal oxinonomano oatlent

Food Ettect on Absorpuon:

Food the no novellability of centralized to the coules and CEDAX Only of the more of the material and mark
The effect of the boardiability of CEDAX Capsules and water a s volution of the Indones is snowed that lood delays the lime of Cms by 1.75 nours. occreases ine
by 18%. and gecreases intent of absoronion (AUC) by 8%

To A and decreases in batten of EDSO DIGE CALL Onl Suspension was evaluated in 18 heattive adult atter a standardied ceatas. Results of a commented a becase overly of 25% and a AUCALE.
atter a standardued coated consideration a becement of CSA and antibio de la MUSA and of 17% and in AUC of 12% when CEOAX Oral Suspension was administered with a low-calone nortal

Biospervatence of Dosage Formatations:

A story in 18 heatmy addi mae wounters demonstrated that Sussense. Awards of CEDAX Carouns
Polyced equivalent concernations to a 400-mg dose of CEDAX Only States of States ( were 80.1 (14.4) ugentler. for the capsure and 87.0 (12.2) ugenrimit for the suspension.

Special Poentations

Geriatric patients: Ceftibuten pharmacokinetics have been investigated in elderly
(65 years of age and older) men (n = 8) and women (n = 41. Each volunteer received celebuten 200-mg
capsules twice daily for 3% davs. The average Cower was 17.5 (3.7) µg/ml after 3 days el sosing com-
pared to 12.9 (2.1) µg/mL after the first dose: ceftibuten accumulation in plasme was 40% at steady
state. Information regarding the renal function of these volunteers was not available; therefore, the sig-
nificance of this finding for clinical use of CEDAX Capsules in siderly betrents is not creer. Ceftibuten
dosage adjustment in elderly pabents may be necessary (see DOSAGE AND ADMINISTRATION).

Micro 中国际

Collinen issus to intribution of coll-wall symbess.
The believen is stable in the symbess.
Cetitution is stable in the presence of most plasmid-mediated beta-lactamases. but This bir

og online of the of connection in the comments on of the a moments and

Ceftibuten has been shown to be active against most strams of the following organisms both in vitro
and in clinical infections (see INDICATIONS AND USAGE):

Gram-pasitive serabas:

Streptococcus pneumoniae (periicillun-susceptible strains only)
Streptococcus pyogenes

Gram-negative nerebes:

Haemophilus influenzae (including B-lactamase-producing strains)

There are no known organism which an e octoral assement an the noicelone and one online onlines and one and one and one and one and one and official one official and estation Property Artists controlled trials.

出现。Carapylobactor, Enterol
MyNococcass, and Saranton
No in vitro actively agames NOTE: Cattibuten is INACTIVE in vitro against Acin stobacter. Bort (except preumonas and pyoganes seccess. In addition, it shows would be and prospection
(except province and pyoganes; seccess. In addition, it snows alle in with and

MIC (ualmi)

ਟ ਨ

Sunsequences (Incluses International Mics provide estimates on estamentes
consembrisons (Inconsiderative methods are estable provinsiones provinsiones provincial provincial p ley of be ein ap a concentrations and standardized concertizente of or or receivere with assessed and Media (HTM):

Internetition1111 - . $ 1 = 1CALL PRODUCT COLLEGION COLLECT COLLEGION CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRAC
(S) Sunceptible

Strains yeals: suggestive of a "Nonsusceptible" category should be submitted to a winners

bearly for the researcy.
I report of 'autimized agent recommended for the strain may be approament vested to
me report of 'autimized agent recommended for that type of intect

on of the of the supervel in formalian and collection in one on onement and ones annoment. A conventeer a comment. A consument a comment and a comment and e comment and entre that are not periicilin-susceptible.
Standardized susceptibility test procedures require the use of laboratory control microon

control the technical aspect of laboratory procedures. Standard cathington personal the tollowing MIC values:

Organism	MIC range (ug/mL)
Haemophilus influenzaeATCC 49274	0.25-1.0

estimates of the susceptiblity of oncere to announce of cone contracted and excellentes associety as one estable as accessories as concented

Reports from the laboratory proving results of the standard supply of the suscentuals tot water and a secondent tot water a onnius species using Haemophilus Test Media (HTM):

Zone diameter (mm)	Interpretation
≥28	(S) Susceptible

The current absence of resistant strains preciudes detiring any categories of her than "Susceptible" Strains yelding results suggestive of a "Nonsusceptible" category should be submitted to a reterence laboratory for further testing

Imerpretation should be as stated above for results using difficion techniques Ceftibuten is indicated for Denicilin-susceptible only strains of Streptococcus onewmoniae

PRODU INFORMATION

{4}------------------------------------------------

Pneumococal isolates with oxacilian zone sizes of ≥20 mm are susceptible to penicilin and can be con-

Field states wir to annum the technica assess on the use of the use of the one of extire on of ye ontrio

Zone grameter (mm)

29-35

tory test quality control strains:

Qroanism omius inttuenzae Haem ATCC 49247

Ceohalosponn-class disks should not be used to test for susceptibility to cefubuten.

indications and USAGE: technique real band.
In costinutes anyon of the secures of indenduals with specific continues in the spective conditions intections in No strains of the designated fricroordanisms sees in the specific concircums insted below caused by susce (see DD E AND AI BORS).

1300 Beterial Eraserations et Circulation of Groups of Security.

HOTE: In acute lasterial exacerations of chronic bronchers clancal anals where Moraction and manufalis

Besterial Otitis Media due to Haemonitus including B-lactamase-aroducing Act a-producing strains), or Streatococcus pyegenes.

strans). Adornunia casarrhalis linche ing 8-lecta ടന്മത്സ്, കോട്ടന്മര്‍ (വലിന്തം വാട്ടോക്കോട് സാമ്പോൾ പാലക്രോസസ്റ്റ് സ് ാഗമേശോസ്ഥാനായ
സ്വീന്‍, Altocologically വാട്ടോസ്റ്റ് വാലയ ശുഖന്ത്ര (Simonomics) (Simplex (Simmer NOTE: Although caltibuton used enn unt to comparators in the treatment of clinically Streetococcussions answer ncally only when adoquests anti-

Black in and Tanalilitir due to StransaCCCUS OVE

NOTE Child by the interescole route of annually offective in the enational of Streets on one of active in the enational of Sheeconomic of Sheecomon of Sheepoor of CEDAX tor t

ICATI C

CEDAX (contraindicated in patients with known allergy to the cephalosponing group of

11 - 11 TO WITH OEDAL IS BISTITUTED. CAREFUL MODEL NOT OF CREACTORS TO OFFECT
A THE PATERIT INSTITUTED SENSER AND PARKET OF THE PATERS OF CONSTITUTION OF TO CONSTITUTION OF CONSULTIO 01日晚报 12月14日 11:00 来源: 11:00:00
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1月 1日 10:17:58 时间:2017-04-07 08:10 08:00
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CONTINUES. CORTICOSTERCASTERCADS. PRESSOR
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arty all morial aponts. teming. Theretore. it is important to con-

agents allers normal flora of the colon and may permit overgrowth of als

14 And The and, appropriate therapount me 1 s at pe anone anyon to management with libert and 18 10 SEVERE C on and tre nort with an are ars home of the more Taxable

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transport TC 11.1 man in applieds were verying degrees of ranal in and of Collection Collins Comments of Concelling Comments of Concerners Corporation Comers of Concerners Corporation Corporation Corporation Comers Corporation of Concerners supportig should be mo 1986 -------

Ca I be prescribed with caution to indiis with a hustory of gastromestinal dis carticularly col

tion to Fallonts:
No should be informa

ont is diabetic, hars H the s the should be intormed that CEDAX Oral Suspension contains

CEDAX Only uncommon should be taken at hast 2 hours before a meas or at least 1 nour atter a

Drug tax

a one 200-ing catabuten caps The S Sans. Will be moming dose of consideracy of consistence on commensed one 2000 C. Canamentes on C. Commenses on C. Canamentes di Creates of themesses comments in themese each volumer recorner recorrect a single intra-

Applies of The enters of Energia Comments of the Final Programments.
Freedom actual vehicles of the Maci and the may The 1017 or AUC of certudures nowner the C. 150 ung of ransidine a12h for 3 day ne a 12h for 3 days mer a the co an Car by 23% as in not implive

DrugAs

anary Test (m)
18 Bosn no Ci ractions with cettibuten noted to date. False-posi There it no chemical or labor There line lists novement sents come with one comment of me comments in and to data, false of an and and and ar assemment as assome as assements as assome as associates mass ore, i a daract Coomos reactions in

Car neale, Muta punesis, impor nt et Fortil ty:

consect and posterial of Personal and Personale Internetic Of antial In anternal Long (CHO) call point mutation assay at the m rats were asministered cettibuten orally up to 2000 mg/kg/day raporoximately 43 times the numan dose
bases on mg/m²/day).

Pregancy, Tarate nine Propensy C.
6 Canada wa Marceles in ma nover on to 400 my contraster in ancomental
6 Canada wa maniyani ( 2 Marc no mano control and manus and transa should be used dunny pregnancy only it clearly needed

Labor and Dolivery:

Cettibuten nas not been studied for use during labor and denetit to both mother and telus.

Nurriag Mothers:

It is not known whether cetuduten i at recommended dosages) is excreted in numan milk. Because it is not known whether centruction is recommended be exercised when certibuten is administered to a nursing woman.

Podizirie Use:

The satery and ethicacy of certibuten in intants less than 6 months of age nas not been established istric Patients

The usual adult dosage recommendation mav be followed for patients in this age group. However these paperss snows be monnored coses, particularly their renal lunction. as ocsage adjustment may De regulired.

ADVENSE EVENTS: al Trials:

In chinical trials. 1728 adurt patients (1092 US and 636 and 636 and 636 and 636 and 636 mere traased with the recom

In the US triats, the lowowing adverse events were thought by the investigators to be possibly, prob-
ably, or almost certainiv related to ceftibuten capsules in multiple-dose clinical trials

ADVERSE REACTIONSCEFTIBUTEN CAPSULESUS CLINICAL TRIALS IN ADULT PATIENTS (n = 1092)
Incidence equal to orgreater than 1%	NauseaHeadacheDiarrheaDyspepsiaDizzinessAbdominal painVomiting	4%3%3%2%1%1%1%
Incidence less than 1% butgreater than 0.1%	AnorexiaConstipationDry mouthDyspneaDysuriaEructationFatigueFlatulenceLoose stoolsMoniliasisNasal congestionParesthesiaPruritusRashSomnolenceTaste perversionUrticariaVaginitis
LABORATORY VALUE CHANGES*CEFTIBUTEN CAPSULESUS CLINICAL TRIALS IN ADULT PATIENTS
Incidence equal to orgreater than 1%	↑ BUN↑ Eosinophils↓ Hemoglobin↑ ALT (SGPT)↑ Bilirubin	4%3%2%1%1%
Incidence less than 1% butgreater than 0.1%	↑ Alk phosphatase↑ Creatinine↑ Platelets↓ Platelets↓ Leukocytes↑ AST (SGOT)

as of whether or not the ance regardia

CEDARSKIN, EVERGREEN, western red

- Changes and the CESS CONSTITY values with consessed connect supercenter movements oncercance researce researce researce recommender concerner concerners concerners of com 19. 97% of whom were ! a 19 mgring ance e

tone curacal main in = 777

ADVERSE REACTIONSCEFTIBUTEN ORAL SUSPENSIONUS CLINICAL TRIALS IN PEDIATRIC PATIENTS (n = 772)
Incidence equal to orgreater than 1%
	Diarrhea*VomitingAbdominal painLoose stools	4%2%2%2%
Incidence less than 1% butgreater than 0.1%
	AgitationAnorexiaDehydrationDiaper dermatitisDizzinessDyspepsiaFeverHeadacheHematuriaHypertonesiaInsomniaIrritabilityNauseaPruritusRashRigors

"NOTE: The increasince of children 52 years old was 8% 123/3011 compared with 2% (9/471) in children >2 vears old.

Regulation Number and Section

§ 866.1620 Antimicrobial susceptibility test disc.

(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).