Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Sparfloxacin Sensi-Discs® are intended for use in determining the susceptibility to Sparfloxacin of a wide range of bacteria, including Staphylococcus aureus, Streptococcus pneumoniae (penicillin-susceptible strains), Enterobacter cloacae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, and Mycoplasma pneumoniae. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Rhone Poulenc Rorer Pharmaceuticals, Inc., and received FDA approval under NDA No. 20-677.

Use of BBL® Sparfloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Sparfloxacin. Sparfloxacin has been shown to be active against most strains of microorganisms listed below, both in vitro and in clinical infections, as described in the Rhone Poulenc Rorer Pharmaceuticals, Inc., package insert for this antimicrobic.

Device Description

Sparfloxacin Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Sparfloxacin supplied by the manufacturer, Rhone Poulenc Rorer Pharmaceuticals, Inc., Collegeville, Pennsylvania. Each Sparfloxacin disc is clearly marked on both sides with the agent and content. Sparfloxacin discs are furnished in cartridges of 50 discs each. Sparfloxacin 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 1940's. 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 regulatory 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 [or 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

This document describes the BBL® Sparfloxacin Sensi-Discs® for antimicrobial susceptibility testing. The data provided focuses on the clinical effectiveness of Sparfloxacin itself, rather than the performance of the Sensi-Discs® as a diagnostic device. The Sensi-Discs® are intended to determine the susceptibility of bacteria to Sparfloxacin using standardized agar diffusion tests.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies, contextualized for the device (Sparfloxacin Sensi-Discs®) where possible, and acknowledging that much of the performance data relates to the drug Sparfloxacin:

1. Table of Acceptance Criteria and Reported Device Performance

For the Sparfloxacin Sensi-Discs®, the acceptance criteria are not explicitly detailed in terms of a device-specific performance study with metrics like accuracy, sensitivity, or specificity against a reference method. Instead, the performance is tied to zone size interpretation and quality control ranges provided by the drug manufacturer (Rhone Poulenc Rorer Pharmaceuticals) and standardized by NCCLS.

Acceptance Criteria (from NCCLS guidelines, applied to disc test)	Reported Device Performance (Implicit via compliance with NCCLS)
*For aerobic microorganisms (other than Haemophilus influenzae):*
Zone Diameter ≥19 mm for Susceptible (S)	Implied to meet these interpretive standards through product design and quality control, as per NCCLS M2-A5. The device's function is to produce these zones.
Zone Diameter 16-18 mm for Intermediate (I)
Zone Diameter ≤15 mm for Resistant (R)
*For Haemophilus influenzae* and Haemophilus parainfluenzae:**
Zone Diameter ≥19 mm for Susceptible (S)	Implied to meet these interpretive standards as above. "The current absence of data on resistant strains precludes defining any category other than 'Susceptible.'"
Quality Control Ranges (Zone Diameter for Disc Diffusion):
Escherichia coli ATCC 25922: 30-38 mm	The device is expected to produce zone diameters within this range for quality control organisms.
Staphylococcus aureus ATCC 25923: 27-33 mm	The device is expected to produce zone diameters within this range for quality control organisms.
MIC Interpretive Standards (Sparfloxacin drug performance, not disc diameter directly):
≤1 µg/mL for Susceptible (S) (for aerobic microorganisms other than Haemophilus influenzae)	The drug (Sparfloxacin) exhibits these MIC values against various organisms. The discs are calibrated to reflect this.
2 µg/mL for Intermediate (I)
≥4 µg/mL for Resistant (R)
<0.25 µg/mL for Susceptible (S) (for Haemophilus influenzae and Haemophilus parainfluenzae)	The drug (Sparfloxacin) exhibits these MIC values against various organisms. "The current absence of data on resistant strains precludes defining ones other than 'Susceptible.'"
Quality Control Ranges (MIC values for Broth Microdilution):
Enterococcus faecalis ATCC 29212: 0.12-0.5 µg/mL	The Sparfloxacin drug is expected to have MICs within this range for quality control organisms when tested by broth microdilution. The discs are calibrated to correlate.
Escherichia coli ATCC 25922: 0.004-0.016 µg/mL
Haemophilus influenzae ATCC 49247a: 0.004-0.016 µg/mL
Staphylococcus aureus ATCC 29213: 0.03-0.12 µg/mL
Streptococcus pneumoniae ATCC 49619b: 0.12-0.5 µg/mL

The primary study mentioned directly concerning the device's acceptable performance is the adherence to the National Committee for Clinical Laboratory Standards (NCCLS) documents M2-A5 and M100-S6. These documents provide the standardized procedures for antimicrobial disk susceptibility tests, including zone size interpretation and quality control limits. The device, by its nature as an "Antimicrobial Susceptibility Test Disc," is designed to be used within these established guidelines.

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

The document does not detail a specific "test set" for the Sparfloxacin Sensi-Discs® themselves, as the approval relies on adherence to established NCCLS standards and the clinical data for the drug Sparfloxacin.

For the drug Sparfloxacin clinical studies (Community-Acquired Pneumonia and Acute Bacterial Exacerbations of Chronic Bronchitis):
- Community-Acquired Pneumonia:
  - Sparfloxacin: n=22 to 41 per organism (total = 199 unique pathogen-patient cases reported across listed organisms)
  - Erythromycin: n=4 to 15 per organism (total = 49)
  - Cefaclor: n=5 to 24 per organism (total = 124)
- Acute Bacterial Exacerbations of Chronic Bronchitis:
  - Sparfloxacin: n=13 to 109 per organism (total = 269 unique pathogen-patient cases)
  - Ofloxacin: n=14 to 95 per organism (total = 277)
- Data Provenance: The clinical studies were conducted "in the United States." The data is prospective, as these are clinical trials comparing drug efficacy.

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

This information is not provided for the Sensi-Discs® themselves or for the clinical studies of the Sparfloxacin drug. For diagnostic device performance, establishing ground truth often involves reference methods performed by qualified laboratory personnel. For the Sensi-Discs®, the "ground truth" for interpretation is implicitly derived from the established NCCLS zone diameter breakpoints, which are scientifically determined standards rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

This information is not provided. For antimicrobial susceptibility testing, adjudication is typically not performed in the same way as in image-based diagnostic studies. The results are quantitative measurements (zone diameters) interpreted against predefined breakpoints. Clinical success in drug trials is usually determined by clinical outcomes and microbiological eradication, not an adjudication process by experts on individual treatment responses in the context of the device's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was done, as this document predates the widespread application of AI in diagnostics and the device (antimicrobial susceptibility disc) is not an AI-powered diagnostic tool. The "readers" in this context are laboratory technicians measuring zone diameters, and their performance is standardized and controlled by NCCLS guidelines and quality control measures, not by AI assistance.

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

This is not applicable. The device is a physical disc used in a laboratory procedure requiring human measurement and interpretation. There is no "algorithm only" component.

7. The Type of Ground Truth Used

For the Sparfloxacin Sensi-Discs® (as a diagnostic device): The ground truth is expert consensus-based standards and recognized reference methods. The interpretive zone sizes and quality control ranges are established by organizations like NCCLS (National Committee for Clinical Laboratory Standards) through a consensus process involving experts in microbiology and infectious diseases, validated against clinical outcomes and MIC data. The "gold standard" for determining MICs (Minimum Inhibitory Concentrations) is typically broth microdilution or agar dilution as per CLSI (formerly NCCLS) guidelines. The disc diffusion method is then correlated to these MIC values.
For the Sparfloxacin drug clinical trials: The ground truth for treatment effectiveness was clinical success (e.g., patient recovery, resolution of symptoms) and pathogen eradication (microbiological cure) demonstrated through follow-up cultures.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. For the Sparfloxacin Sensi-Discs®, the "training data" for establishing breakpoints and QC ranges would implicitly be the extensive historical data and research collected by the NCCLS and drug manufacturers to correlate MICs with zone sizes and clinical outcomes. This would have involved numerous isolates and experiments over time, but is not quantified as a single "training set size" in this document.

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

As discussed above, the concept of a "training set" with ground truth in the AI sense does not apply directly here. For antimicrobial susceptibility testing, the "ground truth" for establishing interpretive breakpoints and quality control ranges (which guide the use of the device) is established through:

Correlation studies: Comparing disc diffusion zone diameters with MIC values obtained from reference methods (e.g., broth microdilution) for a large number of bacterial isolates.
Clinical outcome data: Analyzing the clinical efficacy (patient response) and microbiological eradication rates of the drug in patients infected with organisms having specific MICs and corresponding disc diffusion zone diameters. This helps define the clinical relevance of "susceptible," "intermediate," and "resistant" categories.
Expert consensus: Committees like NCCLS (now CLSI) using all available scientific evidence, including in vitro data and clinical trial results, to determine and periodically update the breakpoints.

In essence, the Sparfloxacin Sensi-Discs® rely on well-established and scientifically validated methodologies rather than new, device-specific performance studies against a novel ground truth. The "study that proves the device meets the acceptance criteria" is primarily the adherence to and validation against the NCCLS standards and the clinical data for the drug itself provided by Rhone Poulenc Rorer Pharmaceuticals.

Summary

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

K970385

Date 1/30/97

SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTED BY:

ﻟﻤﻤﺴﻴﺴﻴﺔ

)

Virginia C. Weinknecht Regulatory Affairs Specialist Becton Dickinson Microbiology Systems P.O. Box 243 Cockeysville, MD 21030-0243

MAR 1 0 1997

NAME OF DEVICE:

Trade Name:	Sparfloxacin, 5 mcg, Sensi-DiscsCatalog Numbers 4331707, 4331708
Common Name/Description:	Antimicrobial Susceptibility Test Discs
Classification Name:	Antimicrobial Susceptibility Test Discs
PREDICATE DEVICE:	Other BBL® Sensi-Discs® such asOfloxacin, 5 mcg, Sensi-Disc®

DEVICE DESCRIPTION:

INTENDED USE:

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

INDICATIONS FOR USE:

Aerobic Gram-Positive Microorganisms

Staphylococcus aureus

Streptococcus pneumoniae (penicillin-susceptible strains)

Aerobic Gram-Negative Microorganisms Enterobacter cloacae
Escherichia coli
Haemophilus influenzae
Haemophilus parainfluenzae
Klebsiella pneumoniae
Moraxella catarrhalis Other Microorganisms
Chlamydia pneumoniae Mycoplasma pneumoniae

PRODUCT DESCRIPTION:

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

(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).

PERFORMANCE DATA:

)

See attached Rhone Poulenc Rorer Pharmaceuticals, Inc., product insert section on Susceptibility Tests - Diffusion Techniques for Zagam® (Sparfloxacin).

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

Tablets Tloxacin.

ﻣﺴﺴﺴﺴ

oxacin, a synthetic broad-spectrum
is-3,5-dimethyl-1-pipers in aminodidus.
Is-3,5-dimetthyl-1-pipers in aminodidus. Be
xylic acid. Its empincal formulas. B
cal structure: Zagame (spano (sparin
antimicrobia) antimicrobial a ablets comtain sparitorial commisticals
-1-cyclopropy-7-leiss n) tab agent
S-Amit na na ni
1.1.4.40
Max and it has the no chemi

Image /page/3/Figure/3 description: The image is a chemical structure diagram of an organic molecule. The molecule contains multiple cyclic rings, including a six-membered ring with two methyl groups and a cyclopropyl group. The structure also includes functional groups such as an amine, carbonyl, and carboxylic acid, as well as fluorine atoms.

charie of 392.41. 85 D Sparfloxacin has l w crystalline
ether. It disannoty soluble in glaci ਸੀ।
And

round, white film-com
collulose NF, magnesi Zagam is available as a 200 evailable Esta Esta 2004
El Nie, The Kollowing 194 osted tablet.
crocrystalling
sium stearst Each 200 ine cellulose NF, and Col-ാന film coating contains: methylhy USP, pol iose USP, polyethylene otyco
CLINICAL PHARMACOLOGY

ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺮﺍﻗﺐ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ Absorption: Sparfloxacin it
absolute oral biolowing
concentration foollawing
1.3 (±0.2) up/n) = The single = the =
1.3 (±0.2) =0.2) =0.7180 = 1188 = 10.0
400-mg oral dosse = ing oral rith 100-mg oral dose was a provincial a poproving
curve limean AUCa -------------------------------------------------------------------------------------------------------------

Steady-state plasma concentration was achieved on the first day by giving a
looding dose that was double the daily dose. Maan (a SC) pharmacounting to the recommonded
dosing dose of the obser
egimen

Dosing Regimen(mg/day)	PeakCmax (µg/mL)	TroughC24 (µg/mL)	AUC 0-24hr. µg/ml
400 mg loading dose (day 1)	1.3 (±0.2)	0.5 (±0.1)	20.6 (±3.1)
200 mg q 24 hours (steady state)	1.1 (±0.1)	0.5 (±0.1)	18.7 (±3.6)

0.5 (±0.1)
400-mg Kot
administration
concentratio Maximu
Typically
Value Gi for the initi
hours follo
eximum pl 1884
1884
1878
1972 - 1974
1972 - 1974
1972 - 1974 - 1974 - 1974 - 1974 - 1974 - 1974 - 1974 - 1974 - 1974 - 1974 - 1974 - 1974 - 1976 - 1976 - 1976 - 1976 - 1976 - 1976 Cor ng 200 . . . . . 8 for a 6 80 dose were also

Oral absorpt
food, includi ion of sparfic
ng high fat m d by administ . O ਨੇ ਨ ੜ੍ਹ ਤੋਂ oral bi ing magnesium hy
ability of sparfloxations
Patients, and Drug hydroxide reduces I
(See PRECAUTIONS క్రంగా in by as mu

Distribution: Upon reaching general
into the body, es reflected by the larger
(Vd.,) of 3.9 (s0.6) L/kg. Sparfloxecin
serum et about 45%. well maan stea ne of distrib g in

Sparfloxacin penetrates well
body fluid distribution stu body fluids and tissues. Results of tissue and at 100 ding plas 0 spartioxi
II. and bro 68 2 to 6 h ulety 3 to
plasma. 8 times r thi n in 0 n the ing co 1 and first

----tion Maso Ratio 19.0%

Respiratory tissuesand fluids	n**value	Time of Collection Postdose2 to 6 hour	12 to 24 hour
alveolar macrophage	6/5	51.8 (88.7%)	68.1 (47.9%)
epithelial lining fluid	10/10	12.3 (26.7%)	17.5 (35.3%)
pulmonary parenchyma	8/7	5.9 (15.0%)	15.8 (32.0%)
bronchial wall	8/7	2.8 (16.0%)	5.7 (25.0%)
bronchial mucosa	6/5	2.7 (11.5%)	3.1 (11.6%)

% CV (percent coefficient of variation) . To the more with two values, the first n is for 2 to 6 hours and the sect
for 12 to 24 hours. d n is

were 0.34 and 0.69 at 4 Mean pleursi effusion to plasma concentration ration

Metabolism: Sparfloxacin is metabolized
curonidation, to form a glucuronide conn conjugate. Its metabolism does not usilia or interfere
P450.

P450.
E11.4 lt 13.55 and 1.5 (18.1 total body)
11.18 lt 3.5) and 1.5 (14.1 last 1.5 km)
19.18.15076) in the article and 1.5 million ask
pon. Following a success and al ci of ebsit Cir Creted in bot tively. Spanoxac
10% of an function foots (50%) and in grid
tion. Forested in groupe
tion. Francosioning
trations 4 proventually
concentrations and the many of the concern of concerner concerner സ് സംസ്ഥാപത്തിനും പ്രാമത്തിന്റെ സ്വീതിക്കുന്നു. അവലംബം പ്രവർത്തിച്ചു. അവലംബം സമീഹത്തിന്റെ സ്വീതിയ സമീഹത്തിന്റെ സ്വീ ശേഷം സ്ഥിത സമീഹത്തിന്റെ സമീഹത്തിന്റെ സ്വാതന്ത്രി സമീഹത്തി in C ss of 12.0 µr m fo mal renal fun

The terminal elimination phase half-life (ty) of spartic generally

varies between 16 and 30 hours, with a mean to of approximately 20 hours.
The 1x, independent of the administered dose, suggesting that
sparfloxacin slimination kinstics are Special Populations

Special Populabors
Gerietric: The pharmacokinetics of sparfloxacin are not altered in the alderly
with normal renal function.

Pediatric: The pharmacokinetics of sparfloxacin in pediatric subjects have

not been studied.
Gender: There are no gender differences in the pharmacokinetics of
sparfloxacin.

ents with renal impairment (creating is engineers on is engineers on the entination is entination is entination is engineers on the contrastination is and conservation one on Renal insufficiency: In pati in), the Single or multiple doses of sparfloxacin in paties of the constitution of the constitution of the series of the series of the articles of the all final formal formeral and fi

Hepatic insufficiancy: The pharmacokinetics of sparfoxacin are not altered MICROBIOLOGY

Sparfloxacin has in viro activity against a wide range of pram-nogative and
gram-positive microopanisms. Sparfoxacin exerts its and ministral propriams.
by inhibiting DNA. op

tion, ropan, access renor, and enother and mode of ection from P-lactam
Quinolones differ in chemical structure and mode of ection from P-lactam
antibiotics. Quinolones may,

tps
It to Although cross-resistance has been observed
other fluoroquinolones, some microorganism
quinolones may be susceptible to sparfloxacin, 1 between
18 resistant in and
flunco.

In vitro tests show that the combination of sparfloxacin and rifampin is
antagonistic against Staphylococcus aureus.

Sparfloxacin has been shown to be active and in clinical infections as described
lowing microorganisms, both in vitro and in clinical infections as described
in the INDICATIO

Aerobic prom-positive m ganismi

Streptococcus pneumoniae (penicillin-susceptible strains)

Aerobic pram-negative micropornanisms

Enterobacter
Haemophilus influen

Haemophilus parainfluenzae
Klebsiella pneumoniae

iella pneumonia
catalla catarrhalis

Other microgrammiams

Chiamydia pneumoniae

ing in vitro data are available, but their clinical significance is The forma

minimal inhibitory concentrations (MICTs) of
t (290%) strains of the following microportion
d effectiveness of sparfloxacin internetinin
icroorganisms have not been establis Sparfloxacin
1 µg/mL or exchibits in
ess against ന്നും
അവലംബം
1988
1988
1998
1998
1998
1998
1998 1998
1998 1998
1998 1998
1998 1998
1998 1998
1998 1998
1998 1998
1998 1998
1998 1998
1998 1998
19 ಿ ಕೆ.
ಉಪಿರಿಯ isms; h 10 thes The Portion Levels

Accubis pram-positive mi organisms

agalactiae

(penicillin-resistant strains) eptococcus
Idens group 2000

CCi Ascabic stam-negative mis

ter anitratus
ter hvolfi

Pantoea agglomerans
Citrobacter diversus
Enterobacter aerogenes

Klebsiella oxytoca
Legionella pneumophila

Morganella morganii
Proteus mirabilis

Proceus vulgaris
Proceus vulgaris
SUSCEPTIBILITY TESTS

SUSCEPTIBILITY TESTS

s). These mibion Dial minima (MIC MIC's pr ty of be mates of the ਨੂੰ ਦ Th ng a US કપ ਵਿੱਚ ਹੈ।
ਹਵਾਲੇ
ਮਾਰਤੀ ਜੀਵਨ
ਮਾਰਤੀ ਜੀਵਨ ਜੀ tions of spandardos The MIC acin powde

For testing aerobic microorganisms other than Heemophilus influ

MIC (µg/mL)	Interpretation
≤1	Susceptible (S)
2	Intermediate (I)
≥4	Resistant (R)
For testing Haemophilus influenzae and Haemophilus parainfluenzae
MIC (µg/mL)	Interpretation
<0.25	Susceptible (S)

• These interpretive standards are applicable only to broth
ceptibility testing with Haemophilus influenzae and Ha

The current absence of data on resistant strains p
ones other than "Susceptible." Strains vietline
"nonsusceptible" category should be submitted
for further testing. MIC reau
MIC reau
Lo La Let ા દાપ્પત

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

ﻟﻤﺴﺴﺴ

ﺭﺳﻴﺴﻴﺔ

land/dil a	HILETPLETBLOUI
	The first and the many of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of theSusceptible (S)

sus using cation-adjusted Mueller-Hinton broth with 2-5% lysed

The current absence of data on resistant strains preciudes defining and suggest
goies other than "Susceptible." Strans vielding MiC msuits suggest
toolsusceptible" category s

r ricres valuel be soloces .
dardined susceptibility test procedures require the use of laboratory control
porganisms to control the technical aspects of the laboratory proce

Microorganism	MIC Range (µg/mL
Enterococcus faecalis ATCC 29212	0.12-0.5
Escherichia coli ATCC 25922	0.004-0.016
Haemophilus influenzae ATCC 49247a	0.004-0.016
Staphylococcus aureus ATCC 29213	0.03-0.12
Streptococcus pneumoniae ATCC 49619b	0.12-0.5

This quality control range is applicable to only H. influenzae ATCC 49247
tested by a broth microdition procedure using Haemophilus Test Medium INTMI

nise ATCC 49619
djusted Muellercontrol range is applicable to on રે.

Thistory arous a reprinted in the stock that require most
the states are reprinted in the success that subcert the sustem the sustem the stoceres and the station of concerner of 180
bace
North State o our

leports from the laboratory providing results of the standard sin
the following sciteria:

shillus influenzas. Haemophilus For asrobic microorganisms other .. ----

Zone Diameter (mm)	Interpretation
≥19	Susceptible (S)
16-18	Intermediate (I)
≤15	Resistant (R)

fivenzae and Heemophilus parainfluenzae should not be tested Straptocogcus Dhe

Zona Diameter Imm)of the production of the contraction and the comments and the consideration and the later the commend and the later the commend of the labor of the larges and the later the c	interpretation
and and and the many of the same of the same of the same of the comments of the comments of the comments of the comments of the comments of219	The program of program and the program and consisted and a commended a commended to a many come of the comments of the comments of the comments of the comments of the commentSusceptible (S)
	These sone dismater standants for Strentnenous nownersian annu pohy t

ests performed using Muelle

The current absence of data on resistant strains procludes any category
than "Susceptiole" Strains vielding zone diameter results suggetive

urther testing.
therpretation involves correlation of the diameter obtained in the disk tea
nterpretation involves correlation of the diameter obtained in the disk tea
he MIC

rith standard dilution I starks are choolon nation internations
Portrol microcorpanism Political
Portiony procedures Following
Estains: to control the te
technique, the ochnical aspects of the circulation

Microorganism	Zone Diameter (mm)ages of agently from the figure with a provide
Eschanchia soli ATCC 25922	30-30-38 38-38
Staphylococcus aureus ATCC 25923	27-33
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	AL AW

Mueller-Hinton agar supplemented with 5% sheep blood દર્શામાં આવેલું એક

IDICATIONS AND USAGE

m (sparlloxacin) is indicated for the transment of adults (a 18 years of age)

Gemmunity-acquired pneumonia caused by Chiamydia pneumoniae.
Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarhalis.
Mycoplasma pnaumoniae, or Streptococcus

Acute bacterial exacter character chemic bronchitis caused by Chiampdia
moniae, Enterbacter cloacae, Haemophilus influenzae, Haemophilus
ரிமலாமல், Kiebialia pneumoniae, Morax

culture and susceptibility to openis The organis The organis The organis The armanis The a
their susceptibility to opening the manistration of The Antiques of There respectio uld be pe ned before treat.
infection and It in o led b lests are known: once

l periodically during theraby will provide information on the
tibility of the pathogen to the antimicrobial agent and also on
ergence of bactenal resistance.

CONTRAINDICATIONS

CONTRAINDICATIONS
Spariloxacin is contraindicated for individuals with a history of hyper
or photosenstivaly reactions.

Torano on anner and Province and Constituent and Manufacturer
Sommercial or more of Control Construct and Caranter Comment
Comments and Ministration Comer Comments of Cana

forest of be avot exposue to the sun, bright natural light, and UV ras
throught of treament of treament and for 5 days after treatment of the treatment of the treasing only
m

WARNINGS

MODERATE TO SETYEE BHOTOTORAL MANAGARANA AND SANA AND SASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MASA MANA MANA RED ASS ED TO DIS
YMPTOMS
BURNING

Ness Startas Sun Croman Croman Croman Comments Andress Andress Andress Andress Andress Andress Andress Andress Andress Andre Comments Andre Comments Comments Comments Comer C terized by by by b
discontinuati
1.1% (n=17).

ﺍﻟﺬﻱ ﻳﻌﺘﺮ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

SPARELON

These phototoxic reactions have been associated with and ੇ ਜਿਹ

THE SAFETY AND EFFECTIVENESS OF SPARFLOXACIN IN CHILDREN, ADO-
LESCENTS (UNDER THE AGE OF 18 YEARS), PREGNANT WOMEN, AND LAC
TATING WOMEN HAVE NOT BEEN ESTABLISHED. (See PRECAUTIONS -
Pregnancy, Nursing Mothers: and Pediatric Use.)

Sparfloxodin has been shown to cause arthropathy in
human doser of 25 mg/kg/kg/sey (anseim) in the states
human doser on a market of 25 mg/kg/sersean and and around around ar 1.9 times the dogs revealed small erosions of cartilage of

Convulsions and toxic paychoses have been reported in tations and min in the minutes of the management.

Nota
Suid-African
Suid-African
Suid-African
Suid-African
Suid-African
Suid-African
Suid-African
Suid-African
Suid-Afr adedness
mnia, and res paranoia
Acts. These patients re
nate meas
sed with c reachdin should and appear d. As in pr Chis d that m
are brai costs Carabler antenoses to serioss on seitures of the one the crait chairement the triang that manant the triang the there that missures that the way the trials we was we wa (6.0 tain drug
Diycemia
Petients,

Serious and occasions, some following the first dose, have hylactoid or inst Crosse. Accomments of Comments
Corporal Comments of Comments of Comments
Comments of Comments of Comments of Comments
Comments of Comments of Comments
Comby and Cont ension/shock. Seizure
Brongue, listyngen, larvingen in the man BSUSCREIN antik

Serious and sometimes fatal events, some due to hypersensnivity, and som

の 2008年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 1

{5}------------------------------------------------

patients receiving ther.
Benerally occur focus from the comments
Researching may ertain etbology, have been reported rere y in ್ಕೆ ಕೆಲ ooses. Clinks
rash or sevel
-Johnson Sy one read
One realitis : nsufficiency o s, faundical throm സമ്മത്തു സസ്ഥാനം മാര മുഖർ നിന്നും സ്വാസ്ത്രം സ്ഥാനം സമ്മാനാവും സമ്മാനാവാമാന്
സ്വനം സ്ഥാനം ചില്പ് കാലാസ് ബാഹ്യത്യസ് മാന്യസ് സസ്യങ്ങൾ
ജനനം സസ്യക്ഷിത്രം (See PRECAUTIONS: അവലംബ

CAUTIONS: Information
with nearly all amilia translation
in severity all amilia transis and the comments of the commission
de childer of the mille the Pseudomembranous colitis has been reported with new in the new
ents, including sparfloxacin, and may range in the world
the sining. Therefore, it is important to the editions

The ment with antibate is a studies indicate that a the colon and may
permit overgrowth of clostridia. Studies indicate that a toxin produced by
Clostridium difficile is one

ക്ഷം നിരമ്പരാദം നിറ്റുക്കാനുണ്ടാക്കാന അക്ഷരത്തി നാടക്കും നേടിക്കുന്നു.
മാധ്പോ നാടക്കാന്മാനം സ്ഥാപന്തരം നിന്നും സമ്പോക്കും വേണ്ടിക
വാസ് നോക്കോഗം വേറ്റിയ സ്വാസംസ്ഥാനം വേട്ടത് colitis ally respond to drug discontinuation
sideration should be given to management with
against C. difficile collection and with the management with
against C. difficile collines. રું. ભાગમાં આવેલું એક ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેત toin
Ora

Pupluss of the shoulder, band, and Achilles tendons that mornel furgical regules from and the control arounds around and the more of the comments of the comments.
There bon

PRECAUTIONS

Generat Adequate hydration of patients receiving sparfloxecin should be main-

minister sparfloxacin with caution in the presence
rout clinical observation and en cappropriate laboration of the prosence
mod prince to and conservation on capitale alience of renal ins to and during the d of spar essary for patients with impaired renal function-creatinine clearance 50 ml.

Avoid the concomitant prescription of medications known to
interval, e.g., erythromycin, terfenadine, assemizole, cisapride, ong the QT,
tamidine, th Contraince anticlepressants. evelic antidepressants, Sparfloxecin is not recommondondono pheno
with pro-amments is not recommiss including programmendondondondonomich pro-ammendonomianons manastial monil ines. IS in

Moderate to severe photoloxicity reactions in this class exposunt in patients
succeso to direct suniph more in this class construction compress compress component

with other quindines, sparficial City, serdar situal serdar with and trith and trith and trith and thith and the colter of the comment
tures of inother of the off of the mail with caution in any predispose to
brai artenoscierosis As with other tain drug therapy, renal dysfunctions ormation for Patients:

Patients should be advised

to sunscreans and lives and lives are inclined sunlight
using sunscreens and litunblocks, reflected, sunt and the summer
exports and strollecitorial vitalians and substant an cluding throught throught the send of the most of the most of exposure the 문을 sun cannot brief e skin as pos na:

to discontinue spartloxacin therapy at the first sign or symptom of ph
ity reaction such as a sentation of skin burning, redness, evealing,
rash, itching or dermatios;

hat a patient who has nenced
void fur . Pl ੇ ਹੋ |
ਜੋ ਕੇ ਉਸ
ਮੈਡ to Sun
solved she has longer, In
stopping completely recovered from th
rare cases. reactions have the reaction or for to whichever is
Freeks after

that sparfloxacin may cause neurologic adverse effects
automobile or machinery or eng (a.g.
ಗಾರದ atzanesa, agrilosacións
other activities in the sparficial a la specifica
El and ADVERSE or ma re they ery or engage in requiring man

to discontinue nue treatment and inform their physician if they experience
on, or rupture of a tendon, and to rest and mifrain from experience until the diag
excluded;

that sparfloxacin can be taken with food or milk or caffeine-containing produccs:

that mineral supplements or vitamins with iron, or zinc, or calcium
taken 4 hours after sparfloxacin administration;

that succellate or magnesium- and aluminum-containing antacids may be
taken 4 hours after spariloxacin administration (see PRECAUTIONS - Drug
interactions);

that sparfloxacin may be
lowing the first dose, and associated with hypersensitivity reactions.
to discontinue the drug at the first sign of a even folskin rash

to drink fluids liberally.

Orug interactions:

Digoxin: Spartloxacin has no effect on the pharmacokinetics of digo

trations. Since there is no interaction with theophyline, interaction writh other
trations. Since there is no interaction with theophylline, interaction writh other
methylxan

Wartarirt Spartloxacin does not increase the anti-coagulant effect of wartann. Cimetidine: Cimetidine does not affect the pharmacokinetics of sparfloxacin.

Cimetides: Cimetine does not allective chamboscin.
Anteriore Andres Aluminate and manuscipality and Promoted Promoter Pro
ent sparticos Alminum and minumes and minumant manu

Zinchron salts: Absorption of quinolones is reduced significantly by these

Probenecid: Probenecid does not atter the pharmacokinetics of sparfloxacin. Drug/Laboratory Test Interactions:

Spartloxacin therapy may produce false-negative culture for

Carcinogenesis. Mutagenesis, Impairment of Fertility:

Carcinogenesis: Sparloxacin was not cartinogenic in mice or rats when art artement
istered for 104 weeks at daily oral doses 3.5 - 5. Steplant in the states of the states of or rats when a

Margarasia: San Sarania been

Imparment of Ferniny. Sparfloxecin had no effect on the fertility or repro
tive performance of male of female rate and to 15.4 times in the ferritoriale in the faction in the

Pregnancy: Teratogenic effects: Pregnancy Category C

45
did 85 eal any in Mas
Might (
100 M
100 M
100 M
100 M 100 M
100 M 100 M 100 M
100 M 100 M
100 M 100 M 100 M
100 M 100 M 100 M
100 M 100 M 100 M
100 M 100 M 100 M
100 clearly matemaily
matermal toxicilly
clearly nationalism
ed upon moving mallering
ed upon moving may many
nce of fetuses with the sinc to the sects, however, increaver, increase in the student were war were war were war were were were were were were were were were were were were werken worder op worder d

Nursing mothers: Sparilose reactions in interts nursing from mille.
potential for serious adverse reactions in infacts nursing from mother in the comment of the comment of th discontinue the drug, takia
mother. (See WARNINGS.)

Pediatric use: Salety and effectiveness have not been established in
the and osteochondrosis Quinclones, including spartnoxacin, causes
the and osteochondrosis in juvenile an WARN NGS I

adverse reactions

in clinical trials. most of the adverse events were mild to moderate in enteres in erents more resert in elerse is and the resert is moders more manarem met
a partiers. This to moderate in
with the recome 6.6%

The most frequently reported a vents (sincesta province of arces of the organization of Property of Property of Property of Chinas of Childred of Children of Children
(2.33%) bably di 11.87

in the nose a cinical trials of shouser treases comments of the mean the me
mended dosepat met most med met met memor memor me me me me
possible of probablement meller met me 217.6%) (3.2%)

Additional possibly or probably related events that occurred in less than 1% of
all patients enrolled in US phase 3 clinical trials are listed below.

BODY AS A WHOLE: fever, chills, face edema, malaise, accidental injury, anabind
luitis, back pain, chills, face edema, malaise, accidental injury, anabhasida arth

GARDOVASCULAR: ANDRESS PARTICO PARKAL ANDREAL ANDRE MANAGER PARTICOLORAL PARTICOLAST PARTO
PART PARTICAL COMES COMES COMPLETERS COMPANIA CONSTITUTION CONSTITUTIO
CASTRONAL CO

GASTROINTESTINAL: constipation, anorexia, gingivitis, oral moniliasis, stom-
atitis, tongue disorder, tooth disorder, gastroenteritis, increased appetite, mouth
ulceration. flatulenca, vomiting:

HEMATOLOGIC: cyanosis, ecchymosis, fymphadenopathy;

METABOLISM: gout, peripheral edema, thirst;

MUSCULOSKELETAL: arthraigia, arthritis, ioint disorder, myalgia:

{6}------------------------------------------------

RESPIRATORY: asthma, epistaxis, pneumonia, minitis, pharyngisis, bronchins,
hemoptysis, sinusitis, cough increased, dyspnea, laryngismus, lung disorder
oleural disorder;

SKIN/HYPERSENSFITY/TY: rash, macuboapular rash, dry skin, herpes simplex,
sweaking, urticala, vesiculobullous rash, exiculative, demando, acon, alcocolar rash,
skin discolor

skin discoloration, herpes zoster, perechal rash;
SPECDAL SENSES: ear pain, amblyopia, photophobia, tinnius, conjunctivitis;
diplopia, abnormainy of accommodation, blephariis

UROGENITAL: vaginitis, dysuna, breast pain, dysmenomea, hematura,
ormagia, nocturia, polyuria, urinary tract infection, kidney pain, leuko
metrorrhagia, vulvovaginal disorde

LABORATORY CHANGES: In the US phase 3 clinical trials, with the cred creats, with the blood cells (1.1%)

increases for the following laboratory tests were are and the more of the more of the more of the more of the more of the more of the many of the management of the commend un vere reported in less than 1% of all all all all all all all all all all all all all all and and and and and and and and and and proteins.

Decreases for the following laboratory tests were reported in less than 1% of also
patients "encolled in clinical trials: albumin, creatinine clearance, hematocrt,

Increases and decreases for the following laboratory tests were reported in
than 1% of all patients in clinical trials: blood glucose, platelets, potessium,
white blood cells

Postmarketing adv ਤੇ additio onship to
cincin other nal fa sis. ac partionalcan
Uption, cand agranuloc
ataxia, buil viactic st n, candiduna
Alluna, dysp . ia, dya is, crystallur
osum, exaction, exactive,
tic necimis,
rstitial poest, embolism.
Themostyriisi
interstriisi
interstriisi
ryngesi or ાં છે. દિવેલા દિવેલા ગુજરાત રાજ્યના દિવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા ulsio ang
110 h oroman hiccough, hiccough, hiccouph, stinal perio a visi Gastranola The More anemia, hopatic necrosis, necrosis, homenia, homono nonomia, nomania, nomania, nomania, nomania, nomania, nomania, nomania, na manatan
Brance, Sciencis, C tis, hiccouroh, hiccouroh,
intestimali pention
lintestimali pentina
renal calculi, met
renal calculi, m mous cell carci ne, sqi ntils
bance, Stovens-Johnson syndrome, squamous centralia, thromania, thromania, thromania, thromania, thromania, thromania,
epidermal necrolysis, toxic psychosis, urinery retemic carcinoma, pui
uvenis, pui nal

Laboratory chang
Diucose, senum serum in the series
Level, hematorial
T-GTP, total biling on of serum trighterides, serum cholesserol, blood
decrease in WBC counts, RBC counts, hemography
mbocyte counts, elevation in GOT, GPT, GFT, ALP, LDH, level, thun

OVERDOSAGE

In case of overdosage, the patient should be monitored in a suipped
modical facility and avvid sun exposum for five days. ECG monitors
ing is recommended due to the possible

It is not known whether sparfloxacin is dialyzable.

Sindle doess of seatloxecin were relatively non-toxic via the ora noute on
astritustiment misseres and destine occures of the arter a more of the antin and com and chini.
Eli

DOSAGE AND ADMINISTRATION

Zagam (sparfloxacin) can be taken th or without food.

Zagam (spanioxacin) can os taxen with of without with comal menal menal menal menal menal menal menal menal menal menal menal menal menal menal menal menal menal menal menars ther, one
I there py

of Zagam in patients with renal impainment ic
is two 200-mg tablets taken on the first day a The recome
stinine clea ed daily
1 450 mil
Breation, dose loading dose. Thereat ાં જિલ્લાનું મુખ્યત્વે ઘઉં, જીવનગર જિલ્લામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાયમાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાયમાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાયમાં આવેલું സ്റ്റ് സ്റ്റ്
പ്രോട്ടി. CLINICAL STUDIES

Cammunity-Ac uired Pneumonia Studies

in the United States, sperfloxacin was compand to environment
The patient clinical success and pathogen eradication rates and celacion
spariloxacin coss and
to of the
rates/pro for thogen eradication In th is,
Sin port . ﯾ ﯿﻮ

Organism	Sparfloxacin	Erythromycin*	Cefaclor
C. pneumoniae	19/22 (86.4%)	3/4 (75%)	5/5 (100%)
H. influenzae	20/24 (83.3%)	0	25/31 (80.6%)
H. parainfluenzae	61/63 (96.8%)	4/4 (100%)	31/41 (75.6%)
M. catarrhalis	7/8 (87.5%)	4/4 (100%)	5/6 (83.3%)
M. pneumoniae	36/39 (92.3%)	15/15 (100%)	20/24 (83.3%)
S. pneumoniae	39/41 (95.1%)	10/11 (90%)	16/17 (94.1%)

· Pathogen numbers were small

Satety

The following table lists possibly end probably drug-related adverse events that

Event	Spamoxacinn=387	Erythromycinn=209	Lefacorn=162
Abdominal Pain	6 (1.6%)	18 (8.6%)	2 (1.2%)
Photosensitivity Reaction	16 (4.1%)	0	1 (0.6%)
QT Interval Prolonged	8 (2.1%)	2 (1.0%)	1 (0.6%)
Sinus Bradycardia	2 (0.5%)	6 (2.9%)	0
Diarrhea	15 (3.9%)	33 (15.8%)	7 (4.3%)
Flatulence	0	5 (2.4%)	0
Nausea	11 (2.8%)	32 (15.3%)	4 (2.5%)
Vomiting	10 (2.6%)	15 (7.2%)	1 (0.6%)
Insomnia	6 (1.6%)	5 (2.4%)	0

Acute Bacterial Exacemations of Chronic Bronchitis Study

Arman Archives Study of acuted States, spaceral exacerballons of Chronic
ononcontailed in the United States, sparticular mass of childred in the more of childred in the reall

Organism	Sparfloxacin	Ofloxacin
H. parainfluenzae	104/109 (95.4%)	90/95 (94.7%)
H. influenzae	51/57 (89.5%)	61/65 (93.8%)
C. pneumoniae	37/45 (82.2%)	35/40 (90%)
M. catarrhalis	36/38 (94.7%)	33/34 (97.1%)
S. pneumoniae	30/34 (88.2%)	20/22 (90.9%)
S. aureus	16/19 (84.2%)	13/14 (92.9%)
K. pneumoniae	17/17 (100%)	15/17 (88.2%)
E. cloacae	12/13 (92.3%)	12/15 (80%)

Salery

The following table lists possibly and probably drug-related adverse events

Event	Sparfloxacin(n=395)	Ofloxacin(n=403)
Headache	11 (2.8%)	6 (1.5%)
Photosensitivity Reaction	29 (7.3%)	3 (0.7%)
Diarrhea	6 (1.5%)	9 (2.2%)
Dyspepsia	8 (2.0%)	14 (3.5%)
Nausea	16 (4.1%)	29 (7.2%)
Dizziness	12 (3.0%)	10 (2.5%)
Insomnia	4 (1.0%)	46 (11.4%)
Taste Perversion	10 (2.5%)	10 (2.5%)
HOW SUPPLIED

Markings C 0075 Blister Pack of 11 5410-11
Bottle of 55 200 mg round, white tablet RPR 201 .

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F).

Caution: Federal law prohibits dispensing without a prescription.

Keep out of the reach of children.

ANIMAL PHARMACOLOGY

Sparfloxacin and other quinolones have been shown to cause arthropathy

Sparfloxacin had no convulsive activity in mice when administered alone on in combin

References

Association of Committee for Clinical Laboratory Standards. Mothods for
Di Nation A Rimicrobial Susceptibility Tests for Bacteria that Greation MT+A3,
Acrocicles

vol. 13, No. 25, NCCSS, Villanova, PA, December, 1993.
2. National Committee for Clinical Laboratory Standards. Performance
Standerds for Antimicrobial Disk Susceptibility

RHÔNE-POULENC RORER PHARMACEUTICALS INC.

COLLEGEVILLE, PA 19426 USA
IN-6300

Rev. 11.95

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).