(35 days)
Not Found
Not Found
No
The device description and intended use describe a traditional agar diffusion method for antimicrobial susceptibility testing using impregnated paper discs. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The interpretation relies on comparing measured zone sizes to established standards.
No
This device is an in vitro diagnostic (IVD) product used to determine the susceptibility of bacteria to Sparfloxacin. It helps select the most suitable antimicrobial therapy but does not directly treat a patient or affect the structure or function of the body.
Yes
The device is used for "semi-quantitative in vitro susceptibility testing" to "determin[e] the susceptibility to Sparfloxacin of a wide range of bacteria". This process involves comparing measured zone sizes to established ranges to determine if an organism is susceptible, intermediate, or resistant to an antimicrobial agent, which is a diagnostic function.
No
The device description clearly states that the device is a physical product consisting of paper discs impregnated with Sparfloxacin. It is a hardware component used in a laboratory procedure.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text explicitly states the device is used for "semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures." The term "in vitro" is a key indicator of an IVD. It also specifies the purpose is to determine the susceptibility of bacteria to Sparfloxacin, which is a diagnostic function performed outside the body.
- Device Description: The description details how the discs are used in a laboratory setting to test bacterial cultures on agar plates. This process of testing biological samples (bacterial isolates) outside the body to aid in diagnosis or treatment decisions is characteristic of an IVD.
- Regulatory Context: The text mentions FDA approval under an NDA (New Drug Application) and adherence to standards from the U.S. Food and Drug Administration (FDA), World Health Organization (WHO), and National Committee for Clinical Laboratory Standards (NCCLS). This regulatory framework is consistent with IVD devices.
- Intended User/Care Setting: The intended user is "Laboratory personnel in a clinical laboratory setting," which is the typical environment for performing in vitro diagnostic tests.
The entire context of the document describes a product used in a laboratory to perform a test on a biological sample (bacterial culture) to provide information relevant to patient care (determining antibiotic susceptibility). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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 codes (comma separated list FDA assigned to the subject device)
Not Found
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Community-Acquired Pneumonia Studies
In the United States, sparfloxacin was compared to erythromycin and cefaclor for community-acquired pneumonia. The clinical success and pathogen eradication rates for sparfloxacin were comparable to the comparators.
| 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
Safety
| Event | Sparfloxacin n=387 | Erythromycin n=209 | Lefacor n=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 Exacerbations of Chronic Bronchitis Study
A study in the United States compared sparfloxacin to ofloxacin for acute bacterial exacerbations of chronic bronchitis. Sparfloxacin demonstrated comparable clinical efficacy.
| 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%) |
Safety
| 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%) |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Other BBL® Sensi-Discs® such as Ofloxacin, 5 mcg, Sensi-Disc®
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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-Discs
Catalog Numbers 4331707, 4331708 |
|--------------------------|----------------------------------------------------------------------|
| Common Name/Description: | Antimicrobial Susceptibility Test Discs |
| Classification Name: | Antimicrobial Susceptibility Test Discs |
| PREDICATE DEVICE: | Other BBL® Sensi-Discs® such as
Ofloxacin, 5 mcg, Sensi-Disc® |
DEVICE DESCRIPTION:
INTENDED USE:
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.
1
INDICATIONS FOR USE:
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.
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:
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
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) | Peak
Cmax (µg/mL) | Trough
C24 (µg/mL) | AUC 0-24
hr. 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 tissues
and fluids | n**
value | Time of Collection Postdose
2 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 |