Charm II Antibiotic Analysis—Grain

Total Page：16

File Type：pdf, Size：1020Kb

Charm ii Antibiotic Analysis for Grain Products PROCeDURAL FLOWCHART + Binding Tracer Reagent Tablet Tablet Sample Charm ii 7600 analyzer Incubate START STOP Centrifuge Families DeteCteD = Aminoglycosides = Amphenicols/Chloramphenicol Resuspend = Beta-lactams = Macrolides = Sulfonamides C2Soft = Tetracyclines (optional) Count Results SAMPLE SIZe 50 to 100 g Computer Report SAMPLE PREPARATION Homogenize product in extraction solution for 60 seconds. Filter or centrifuge for 3 minutes. sample printout Test supernatant. Date = 08/23/10 preparation time Approximately 10-15 minutes, Time = 14:28:12 depending on the number of Operator = 1 samples. Time Counted = 60 Sample I.D. = 7764 ASSAY TIME Approximately 10 minutes, depending on drug family. Assay = Chloramphenicol CAPACITY 6 to 12 samples in assay, Lot# = ATBL 014 depending on drug family. Control Point = 2564 Sample (CPM) = 3676 Interpretation = Not Found Charm sciences, inc. 659 Andover Street, Lawrence, MA 01843, USA | Tel: +1.978.687.9200 | www.charm.com Charm ii Antibiotic Analysis for Grain Products Charm ii Kit Drug test sensitivity 1 (ppb) aminoglycosides (STIIHG) Streptomycin 2000 Dihydrostreptomycin 7500 Gentamicin 5000 aminoglycosides (GIIHG) Gentamicin 1000 Neomycin 500 Beta-lactams (PIIG) Penicillin-G 200 Amoxicillin 450 Ampicillin 400 Cephapirin 200 Ceftiofur 500 Cloxacillin 2500 Oxacillin 3750 Dicloxacillin 2500 Cefazolin 1500 Cefodroxil 1500 Cefotaxime 400 Cephalexin 1500 Cephradine 1500 Cefquinome 1000 Hetacillin 400 Nafcillin 3000 Penethamate 200 Piperacillin 1000 Ticarcillin 3500 Chloramphenicol Chloramphenicol 40 Florfenicol 160 & other amphenicols (CIIHG) Thiamphenicol 200 Chloramphenicol (AIIHG) Chloramphenicol 5 macrolides (EIIG) Erythromycin 1000 Tylosin 1000 Spiramycin 1000 Pirlimycin 2000 Tilmicosin 1000 Lincomycin 2500 sulfonamides (SMIIHG) Sulfamethazine 500 Sulfadimethoxine 200 Sulfathiazole 400 Sulfadiazine 200 tetracyclines (TIIHG) Tetracycline 100 Chlortetracycline 800 Oxytetracycline 800 1 Exceed 90% positive at a 95% confidence limit Charm sciences, inc. 659 Andover Street, Lawrence, MA 01843-1032, USA Tel: +1.978.687.9200 | Fax: +1.978.687.9216 | Email: [email protected] | www.charm.com © Copyright 2010 Charm Sciences, Inc. Charm is a registered trademark of Charm Sciences, Inc. MRK-123-001 0810 .

Copy Link

Recommended publications

Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Augmentin 125 mg/31.25 mg/5 ml powder for oral suspension Augmentin 250 mg/62.5 mg/5 ml powder for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted, every ml of oral suspension contains amoxicillin trihydrate equivalent to 25 mg amoxicillin and potassium clavulanate equivalent to 6.25 mg of clavulanic acid. Excipients with known effect Every ml of oral suspension contains 2.5 mg aspartame (E951). The flavouring in Augmentin contains maltodextrin (glucose) (see section 4.4). This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium- free’. When reconstituted, every ml of oral suspension contains amoxicillin trihydrate equivalent to 50 mg amoxicillin and potassium clavulanate equivalent to 12.5 mg of clavulanic acid. Excipients with known effect Every ml of oral suspension contains 2.5 mg aspartame (E951). The flavouring in Augmentin contains maltodextrin (glucose) (see section 4.4). This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium- free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral suspension. Off-white powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): • Acute bacterial sinusitis (adequately diagnosed) • Acute otitis media • Acute exacerbations of chronic bronchitis (adequately diagnosed) • Community acquired pneumonia • Cystitis • Pyelonephritis 2 • Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis • Bone and joint infections, in particular osteomyelitis.
[Show full text]
Staphylococcus Aureus Bloodstream Infection Treatment Guideline
Staphylococcus aureus Bloodstream Infection Treatment Guideline Purpose: To provide a framework for the evaluation and management patients with Methicillin- Susceptible (MSSA) and Methicillin-Resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI). The recommendations below are guidelines for care and are not meant to replace clinical judgment. The initial page includes a brief version of the guidance followed by a more detailed discussion of the recommendations with supporting evidence. Also included is an algorithm describing management of patients with blood cultures positive for gram-positive cocci. Brief Key Points: 1. Don’t ignore it – Staphylococcus aureus isolated from a blood culture is never a contaminant. All patients with S. aureus in their blood should be treated with appropriate antibiotics and evaluated for a source of infection. 2. Control the source a. Removing infected catheters and prosthetic devices – Retention of infected central venous catheters and prosthetic devices in the setting of S. aureus bacteremia (SAB) has been associated with prolonged bacteremia, treatment failure and death. These should be removed if medically possible. i. Retention of prosthetic material is associated with an increased likelihood of SAB relapse and removal should be considered even if not clearly infected b. Evaluate for metastatic infections (endocarditis, osteomyelitis, abscesses, etc.) – Metastatic infections and endocarditis are quite common in SAB (11-31% patients with SAB have endocarditis). i. All patients should have a thorough history taken and exam performed with any new complaint evaluated for possible metastatic infection. ii. Echocardiograms should be strongly considered for all patients with SAB iii. All patients with a prosthetic valve, pacemaker/ICD present, or persistent bacteremia (follow up blood cultures positive) should undergo a transesophageal echocardiogram 3.
[Show full text]
Current Use for Old Antibacterial Agents: Polymyxins, Rifamycins, and Aminoglycosides
Current Use for Old Antibacterial Agents: Polymyxins, Rifamycins, and Aminoglycosides a, b,c Luke F. Chen, MBBS (Hons), MPH, CIC, FRACP *, Donald Kaye, MD KEYWORDS Rifaximin Pharmacokinetics Pharmacodynamics Toxicity Polymyxins Aminoglycoside Rifampin The polymyxins, rifamycins, and the aminoglycosides may be considered special use antibacterial agents. They are all old agents and are rarely considered the drugs of choice for common bacterial infections. The polymyxins are increasingly important because of the continued emergence of multidrug resistant (MDR) gram-negative organisms, such as strains of Pseudomonas aeruginosa or carbapenemase-producing Enterobacteriaceae that are susceptible to few remaining drugs. Rifampin is only considered in the context of nonmycobacterial infections where its role is limited and sometimes controversial. Rifaximin is a new enteric rifamycin that is increasingly used for gastrointestinal infections such as trav- eler’s diarrhea and Clostridium difficile infections (CDIs). This article will also review the current role of aminoglycosides in nonmycobacterial systemic infections, with an emphasis on the use of single daily administration. POLYMYXINS The polymyxins were discovered in 1947. Although there are five known polymyxin molecules, sequentially named polymyxin A through polymyxin E, only two polymyxins are available for therapeutic use: polymyxin B and polymyxin E (colistin) (Table 1). Both polymyxin B and polymyxin E are large cyclic cationic polypeptide detergents A version of this article appeared in the 23:4 issue of the Infectious Disease Clinics of North America. a Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Box 102359, Hanes House, Durham, NC 27710, USA b Department of Medicine, Drexel University College of Medicine, Philadelphia, PA 19102, USA c 1535 Sweet Briar Road, Gladwyne, PA 19035, USA * Corresponding author.
[Show full text]
MICU Antibiotics and Associated Drug Interactions
MICU Antibiotics and Associated Drug Interactions Resistant Bacteria ► MICU patient are at risk for resistant organisms: § Recent hospitalizations § From a skilled nursing facility § Immunocompromised patients ►Transplant population ►Chronic steroid use Organisms of Concern ► Gram Negative organisms § Pseudomonas aeruginosa § Acinetobacter § Klebsiella pneumoniae ► ESBL § E.Coli ► ESBL ► Staph Aureus § MRSA ► Enterococcus faecalis & faecium § VRE Antibiotic Management Program (AMP) ► Patient safety initiative to address: § The infections related to C. difficile § Increasing antimicrobial resistance § Increasing antimicrobial cost Commonly Used Restricted Antibiotics ► Must call AMP to get an approval code (Full list on page 12 of Guide to Antimicrobial Chemotherapy) § Commonly used agents ► Ciprofloxacin ► Moxifloxacin ► Linezolid ► Ceftriaxone ► Ceftazidime ► Aztreonam ► Daptomycin ► Clindamycin ► Meropenem ► Imipenem ► Oral Vancomycin—unless you fill out a C.diff order set Not Restricted in the ICU ► Vancomycin ► Zosyn (piperacilin/tazobactam) ► Cefepime ► Aminoglycosides § Gentamicin § Tobramycin Pharmacodynamics ► Concentration dependant killing ► Goal: maximize the concentration § AUC/MIC ratio and Peak/MIC are predictors of efficacy § Antibiotics kill with increasing antibiotic concentrations at a greater rate and extent § Aminoglycosides ►Fluoroquinolones ►Metronidazole Pharmacodynamics ► Time dependent killing ► Goal: Maximize duration of exposure § T > MIC correlates best with efficacy ►Antibiotics kill bacteria at the same rate
[Show full text]
Interest in the Physical, Chemical and Spectroscopic Properties of the P
VOL. XXVII NO. 3 THE JOURNAL OF ANTIBIOTICS 215 A CHIROPTICAL STUDY OF PENICILLINS L. A MITSCHER, PETER W. HOWISON* and THEODORE D. SOKOLOSKI Division of Natural Products Chemistry The Ohio State University, Columbus, Ohio 43210. U.S. A. (Received for publication November 9, 1973) ORD and CD spectra are reported for a series of penicillin antibiotics and related degradation products. The results, when compared with published X-ray data, suggest that some conformational changes can apparently go undetected by chiroptical techniques in this series and that the side chain substituent at C6 plays a relatively minor role in determining the sign and intensity of the COTTON effect unless its stereochemistry is inverted. The rather large spectroscopic effect following Ca epimerization has potential for development as an assay for the percentage of 6-epihetacillin in a given mixture. Some preliminary data are presented showing the utility of this method for investigating the kinetics of CB epimerization. Semiempirical predictive rules developed for simple amides are inadequate for rationalizing the penicillin spectra. The origin of the COTTON effects is briefly discussed and contrasted with the cephalosporin antibiotics. Interest in the physical, chemical and spectroscopic properties of the p-lactam antibiotics remains high because of their outstanding clinical utility and a desire to rationalize their mode of action on a molecular level. A recent review volume has collected much of this scattered information1). One of the techniques which has found wide application for the study of the stereo-chemistry and solution conformation of antibiotics is optical rotatory dispersion and circular dichroism spectroscopy2). Although CD measurements of the cephalosporins have been discussed 3,4) no corresponding study of the chiroptical properties of the penicillins has yet appeared except in brief extracts'.
[Show full text]
Ceftaroline Fosamil for the Treatment of Gram-Positive Endocarditis: CAPTURE Study Experience
International Journal of Antimicrobial Agents 53 (2019) 644–649 Contents lists available at ScienceDirect International Journal of Antimicrobial Agents journal homepage: www.elsevier.com/locate/ijantimicag Ceftaroline fosamil for the treatment of Gram-positive endocarditis: CAPTURE study experience ∗ Christopher J. Destache a, David J. Guervil b, Keith S. Kaye c, a School of Pharmacy and Health Professions, Creighton University, Omaha, NE, USA b Memorial Hermann-Texas Medical Center, Houston, TX, USA c Wayne State University and Detroit Medical Center, Detroit, MI, USA a r t i c l e i n f o a b s t r a c t Article history: Background: The clinical experience of ceftaroline fosamil (CPT-F) therapy for Gram-positive infective Received 3 October 2018 endocarditis is reported from CAPTURE, a retrospective study conducted in the USA. Accepted 27 January 2019 Methods: Data, including patient demographics, medical history, risk factors, microbiological aetiology and clinical outcomes, were collected by review of patient charts between September 2013 and February Editor: Professor Matthew Falagas 2015. Results: Patients ( n = 55) with Gram-positive endocarditis were treated with CPT-F. The most common Keywords: risk factors were intravascular devices (43.6%), diabetes mellitus (40.0%) and injection drug use (38.2%). Ceftaroline fosamil Gram-positive endocarditis The most commonly isolated pathogens were meticillin-resistant Staphylococcus aureus (MRSA; 80%), Meticillin-resistant Staphylococcus aureus meticillin-susceptible S. aureus (MSSA; 7.3%) and coagulase-negative staphylococci (7.3%). CPT-F was given Meticillin-susceptible Staphylococcus aureus as ﬁrst-line therapy in 7.3% of patients and as second-line or later therapy in 92.7% of patients, and as CAPTURE study monotherapy in 41.8% of patients and as concurrent therapy in 58.2% of patients.
[Show full text]
DICLOXACILLIN SODIUM- Dicloxacillin Sodium Capsule Teva Pharmaceuticals USA, Inc
DICLOXACILLIN SODIUM- dicloxacillin sodium capsule Teva Pharmaceuticals USA, Inc. ---------- Dicloxacillin Sodium Capsules USP Rx only To reduce the development of drug resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Dicloxacillin sodium, USP is a semisynthetic antibiotic substance which resists destruction by the enzyme penicillinase (beta - lactamase). It is monosodium (2S,5R,6R)-6-[3-(2,6-dichlorophenyl)-5- methyl-4-isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylate monohydrate. Dicloxacillin is administered orally via capsule form or powder for reconstitution. Structurally, dicloxacillin sodium, USP may be represented as follows: C19H16Cl2N3NaO5 S·H2O MW 510.32 Inactive Ingredients Capsules Magnesium Stearate. Capsule Shell and Print Constituents D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #1, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10, Gelatin, Shellac, Sodium Lauryl Sulfate, Sorbitan Monolaurate, Black Iron Oxide, Titanium Dioxide, Propylene Glycol. CLINICAL PHARMACOLOGY Microbiology Mechanism of Action Penicillinase-resistant penicillins exert a bactericidal action against penicillin-susceptible microorganisms during the state of active multiplication. All penicillins inhibit the biosynthesis of the bacterial cell wall. bacterial cell wall. Antibacterial Activity Dicloxacillin sodium has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Gram-positive Bacteria Staphylococcus spp.
[Show full text]
Gram Positive Cocci (GPC) Gram Neg (Rods = GNR) Anaerobes
Gram Positive Cocci (GPC) Gram Neg (rods = GNR) Anaerobes Atypicals Classification Antibiotic Cluster Streptococcus Entero- Resp Enteric Non- Bacteroides, Mycoplasma = Staph β↓ & α-hemolytic↓ coccus (cocci) GI flora enteric Clostridium Legionella Beta-Lactams General Spectrum MSSA Group pneumo, faecalis H. flu, E. coli, Pseud- (non-dfficile) Chlamydia Penicillins of Activity → only A / B Viridans only M. cat Klebsiella omonas Peptostrep. (pneumonia) Natural Penicillin G IV/ PenVK PO +/- ++ + + 0 0 0 + 0 Anti- Oxacillin/Nafcillin IV, ++ ++ + 0 0 0 0 0 0 Staphylococcal Dicloxacillin PO Aminopenicillins Amp/Amoxicillin IV/PO 0 ++ + ++ +R +/- 0 + 0 Anti-Pseudomonal Piperacillin/Ticarcillin IV 0 + + + + + ++R + 0 Beta-Lactamase Clavulanate IV/PO, sulbactam Increase Inc by Increase Increase Inhibitor added tazobactam, vaborbactam IV by + + by + by + Cephalosporins Cefazolin IV/ ++ ++ +/- 0 +/- + 0 0 0 1st Generation Cephalexin PO 2nd Generation Cefuroxime IV/PO + ++ + 0 + + 0 +/- 0 Cephamycins Cefoxitin/Cefotetan IV 0 + 0 0 + + 0 + 0 3rd Generation Ceftriaxone/Cefotaxime IV + ++ ++ 0 ++ ++R 0 +/- 0 (PO in between 2nd Ceftazidime IV (+ Avibactam 0 + 0 0 ++ ++R ++R 0 0 and 3rd gen) for Carb-Resistant Enterics) 4th Generation Cefepime IV + ++ ++ 0 ++ ++ ++R 0 0 Novel Ceftolozane-tazo/Cefiderocol 0 + + 0 ++ ++ ++ +/- 0 Carbapenems Imipenem, Meropenem IV + + + +/- ++ ++ ++R ++ 0 (+rele/vaborbactam for CRE) Ertapenem IV + ++ ++ 0 ++ ++ 0 ++ 0 Monobactam Aztreonam IV 0 0 0 0 ++ ++R + 0 0 Non β-Lactams Includes MRSA Both sp. Aminoglycosides Gentamicin,
[Show full text]
Benzylpenicillin / Dihydrostreptomycin Sul- Phate / Nafcillin Formulation
SAFETY DATA SHEET Benzylpenicillin / Dihydrostreptomycin Sul- phate / Nafcillin Formulation Version Revision Date: SDS Number: Date of last issue: 30.10.2020 2.0 09.04.2021 7213846-00002 Date of first issue: 30.10.2020 SECTION 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Benzylpenicillin / Dihydrostreptomycin Sulphate / Nafcillin For- mulation Manufacturer or supplier's details Company : MSD Address : Rua Coronel Bento Soares, 530 Cruzeiro - Sao Paulo - Brazil CEP 12730-340 Telephone : 908-740-4000 Emergency telephone : 1-908-423-6000 E-mail address : [email protected] Recommended use of the chemical and restrictions on use Recommended use : Veterinary product SECTION 2. HAZARDS IDENTIFICATION GHS Classification in accordance with ABNT NBR 14725 Standard Respiratory sensitization : Category 1 Skin sensitization : Category 1 Specific target organ toxicity - : Category 2 (ear, Kidney, inner ear) repeated exposure (Oral) Aspiration hazard : Category 1 Short-term (acute) aquatic : Category 2 hazard Long-term (chronic) aquatic : Category 4 hazard GHS label elements in accordance with ABNT NBR 14725 Standard Hazard pictograms : Signal Word : Danger Hazard Statements : H304 May be fatal if swallowed and enters airways. H317 May cause an allergic skin reaction. H334 May cause allergy or asthma symptoms or breathing 1 / 18 SAFETY DATA SHEET Benzylpenicillin / Dihydrostreptomycin Sul- phate / Nafcillin Formulation Version Revision Date: SDS Number: Date of last issue: 30.10.2020 2.0 09.04.2021 7213846-00002 Date of first issue: 30.10.2020 difficulties if inhaled. H373 May cause damage to organs (ear, Kidney, inner ear) through prolonged or repeated exposure if swallowed. H401 Toxic to aquatic life. H413 May cause long lasting harmful effects to aquatic life.
[Show full text]
Benzylpenicillin / Dihydrostreptomycin Sul- Phate / Nafcillin Formulation
SAFETY DATA SHEET Benzylpenicillin / Dihydrostreptomycin Sul- phate / Nafcillin Formulation Version Revision Date: SDS Number: Date of last issue: 30.10.2020 1.1 09.04.2021 7213864-00002 Date of first issue: 30.10.2020 SECTION 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Benzylpenicillin / Dihydrostreptomycin Sulphate / Nafcillin Formulation Manufacturer or supplier's details Company name of supplier : MSD Address : 2000 Galloping Hill Road Kenilworth - New Jersey - U.S.A. 07033 Telephone : 908-740-4000 Emergency telephone : 1-908-423-6000 E-mail address : [email protected] Recommended use of the chemical and restrictions on use Recommended use : Veterinary product SECTION 2. HAZARDS IDENTIFICATION GHS Classification Respiratory sensitization : Category 1 Skin sensitization : Category 1 Specific target organ toxicity : Category 1 (ear, Kidney, inner ear) - repeated exposure (Oral) Aspiration hazard : Category 1 GHS label elements Hazard pictograms : Signal Word : Danger Hazard Statements : H304 May be fatal if swallowed and enters airways. H317 May cause an allergic skin reaction. H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled. H372 Causes damage to organs (ear, Kidney, inner ear) through prolonged or repeated exposure if swallowed. Precautionary Statements : Prevention: P260 Do not breathe mist or vapors. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P272 Contaminated work clothing should not be allowed out of the workplace. P280 Wear protective gloves. P284 Wear respiratory protection. 1 / 18 SAFETY DATA SHEET Benzylpenicillin / Dihydrostreptomycin Sul- phate / Nafcillin Formulation Version Revision Date: SDS Number: Date of last issue: 30.10.2020 1.1 09.04.2021 7213864-00002 Date of first issue: 30.10.2020 Response: P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/ physician.
[Show full text]
Antibiotic Classes
Penicillins Aminoglycosides Generic Brand Name Generic Brand Name Amoxicillin Amoxil, Polymox, Trimox, Wymox Amikacin Amikin Ampicillin Omnipen, Polycillin, Polycillin-N, Gentamicin Garamycin, G-Mycin, Jenamicin Principen, Totacillin, Unasyn Kanamycin Kantrex Bacampicillin Spectrobid Neomycin Mycifradin, Myciguent Carbenicillin Geocillin, Geopen Netilmicin Netromycin Cloxacillin Cloxapen Paromomycin Dicloxacillin Dynapen, Dycill, Pathocil Streptomycin Flucloxacillin Flopen, Floxapen, Staphcillin Tobramycin Nebcin Mezlocillin Mezlin Nafcillin Nafcil, Nallpen, Unipen Quinolones Oxacillin Bactocill, Prostaphlin Generic Brand Name Penicillin G Bicillin L-A, First Generation Crysticillin 300 A.S., Pentids, Flumequine Flubactin Permapen, Pfizerpen, Pfizerpen- Nalidixic acid NegGam, Wintomylon AS, Wycillin Oxolinic acid Uroxin Penicillin V Beepen-VK, Betapen-VK, Piromidic acid Panacid Ledercillin VK, V-Cillin K Pipemidic acid Dolcol Piperacillin Pipracil, Zosyn Rosoxacin Eradacil Pivampicillin Second Generation Pivmecillinam Ciprofloxacin Cipro, Cipro XR, Ciprobay, Ciproxin Ticarcillin Ticar Enoxacin Enroxil, Penetrex Lomefloxacin Maxaquin Monobactams Nadifloxacin Acuatim, Nadoxin, Nadixa Generic Brand Name Norfloxacin Lexinor, Noroxin, Quinabic, Aztreonam Azactam, Cayston Janacin Ofloxacin Floxin, Oxaldin, Tarivid Carbapenems Pefloxacin Peflacine Generic Brand Name Rufloxacin Uroflox Imipenem, Primaxin Third Generation Imipenem/cilastatin Balofloxacin Baloxin Doripenem Doribax Gatifloxacin Tequin, Zymar Meropenem Merrem Grepafloxacin Raxar Ertapenem
[Show full text]
N200327s0160
Clinical Review Sheral S. Patel, M.D. NDA 200327 SD478 S-16 and S-17 Ceftaroline fosamil (Teflaro®) CLINICAL REVIEW Application Type Pediatric Efficacy Supplements Application Number(s) NDA 200327 SD478 S-16 and S-17 Priority or Standard Priority Submit Date 7 December 2015 Received Date 7 December 2015 PDUFA Goal Date 7 June 2016 Division/Office Division of Anti-Infective Products/ OAP/ OND/ CDER Reviewer Name Sheral S. Patel, M.D. Team Leader Hala Shamsuddin, M.D. Review Completion Date 13 May 2016 Established Name Ceftaroline fosamil (Proposed) Trade Name Teflaro® Applicant Cerexa, Inc. (A Subsidiary of Forest Laboratories, LLC.) Formulation(s) Powder for Injection Dosing Regimen 1. Children aged 2 months to < 2 years: 8 mg/kg every 8 hours IV administered over 5 to 60 minutes 2. Children and adolescents aged 2 years to ≤ 18 years: 12 mg/kg (up to a maximum of 400 mg for pediatric patients weighing > 33 kg) q8h by IV infusion administered over 5 to 60 minutes Applicant Proposed For the pediatric population 2 months to < 18 years Indication(s)/Population(s) 1. Acute bacterial skin and skin structure infections 2. Community acquired bacterial pneumonia Recommendation on Approval Regulatory Action Recommended For the pediatric population 2 months to < 18 years Indication(s)/Population(s) 1. Acute bacterial skin and skin structure infections (if applicable) 2. Community acquired bacterial pneumonia CDER Clinical Review Template 2015 Edition 1 Reference ID: 3933750 Clinical Review Sheral S. Patel, M.D. NDA 200327 SD478 S-16 and S-17 Ceftaroline fosamil (Teflaro®) Table of Contents Glossary ........................................................................................................................................
[Show full text]