By H. Faesul. The Stefan University. 2019.

Phages are efective against multidrug resistant pathogenic bacteria because the mechanisms by which they induce bacteriolysis difer com- 2 buy primaquine 15mg fast delivery. Moreover discount 15mg primaquine overnight delivery, phage has self- limitation discount primaquine 15 mg mastercard, meaning that the number of phages remains at 2 cheap 15 mg primaquine mastercard. Te supernatant was decanted into of phenol : chloroform was added to remove proteinaceous a separate sterile container and mixed with polyethylene material. Te resulting precipitate was dissolved in 5 mL of phage according to standard procedure. An aliquot (200 L) of this processed sewage was carried out following the instructions supplied by man- was mixed with 100 LofanovernightcultureofP. Phage plaques were harvested bred, virgin adult Swiss mice (Wistar strain) of both sexes from the plate, and single plaques were purifed thrice on host with the commendation of the Institute Animals Ethics Com- strains. Large Scale Amplifcation and Purifcation of Phage were fed standard pellet and water ad libitum. Phage was purifed according to the procedure of mice received an intraperitoneal injection of 60, 120, 150, described by Biswas et al. Blood glucose levels were monitored ment, 6- to 8-week-old diabetic and nondiabetic mice were by drawing blood from the tail vein [7]. Indirect enzyme-linked immunosorbent assay was were centrifuged at 8000 rpm for 5 min. Afer appropriate dilution, turbidity at 600 nm was measured to determine bacterial cell numbers. With the intention to know 7 8 9 the histological changes during the course of therapy by serial dilutions of P. Afer infection, mice gross examination of spleen, liver, kidney, and lung was done were kept under standard laboratory conditions with free and dissected out. Six mice were used for each dose; dehydrated in an ascending series of alcohol (70–100%). Te the survival rates of nondiabetic and diabetic mice were then tissue was embedded in parafn wax, sectioned, and stained measured at 2 days afer infection [8]. Te frst two diabetic and nondiabetic isolates from diabetic samples were used for isolation of groups received no antibiotic; the remaining groups received lytic bacteriophage. Te isolated phage was found to form −1 plaques on four imipenem susceptible clinical isolates and intraperitoneal injections of imipenem [30 mg (kg of body also inhibited bacterial growth of two imipenem resistant weight)] afer 20 min of pathogen administration. Treatment of Diabetic and Nondiabetic Bacteremic Mice tively placed in the Siphoviridae family (Ackermann, 2001). Among 12 4 BioMed Research International 120 110 100 100 90 80 80 70 60 60 50 40 40 20 30 20 0 0 10 Post P. On comparing nondiabetic mice whereas 10% diabetic mice died during the the protective efcacy of phage therapy with chemother- subsequent 7-day observation period. In contrast, injections 7 apeutic treatment of diabetic and nondiabetic bacteremic of P. Efcacy of Phage against Lethal Bacteremia in Diabetic and nondiabetic mice from P. BioMed Research International 5 120 120 100 100 80 80 60 60 40 40 20 20 0 0 0 0 1 2 3 4 5 6 7 Post-P. Te Immune Response to Phage in Diabetic and Nondi- comparison, nondiabetic bacteremic mice were rescued 90%, abetic Mice. When treatment was delayed beyond 20 h, only foldand100-fold,respectively,inbothgroups. Te imipenem treated group of infected mice revealed thickened splenic capsule with subcapsular dark pigments possibly hemosiderin (Fig- 60 ure 6(b)). Te group of infected mice treated with phage showed little expansion of red pulp, and restricted white pulps were detected. Te 40 appearance of degeneration was common all over the spleen tissue with some of the improvement in phage treated mice 20 (Figure 6(a)). Histological examination of the group showed normal architecture with occasional dilated central vein with feathery 0 degeneration of hepatocytes (Figure 7(d)). Te section of 4 diseased mice showed degeneration of hepatocytes with focal Time (hours) areas of hemorrhages (Figure 7(c)). Te segment of the liver from the antibiotic treated mice showed eccentrically placed Diabetic Non diabetic nuclei with vacuolated cytoplasm and few of hepatocytes showing feathery degeneration of hepatocytes with focal Figure 4: Delayed phage treatment of diabetic and nondiabetic bac- areas of hemorrhage (Figure 7(b)). Delayed phage administration rescued signifcantly higher numbers Histological examination of the normal structure of the of nondiabetic bacteremic mice than diabetic bacteremic mice. Micro- small airways obstructed with beads and localized cell scopic examination of the kidney in diseased mice infected infammation were observed. Discussion architecture with glomeruli and tubules lined by epithelium with eosinophilic cytoplasm; this showed to be a sign of P. Animals with blood glucose levels >250 mg/dL were considered a diabetic imipenem treatment in diabetic mice correlates with the model. Te present study animals have reached maturity and with negligible weight loss provides the frst experimental evidence that administration [13, 14]. However, 100% mortality occurred in diabetic mice towards phage therapy was once more accompanied by a within 36 h, in contrast to 100% in nondiabetic mice at renewed interest and reappraisal of the beginning of the 21st 48 h. Te innocuous nature of phage was demon- diabetic bacteremic mice than in nondiabetic bacteremic strated by adding high-titer T4 phage stock to the drinking 8 BioMed Research International (a) (b) (c) (d) Figure 6: Histopathology of the spleen. In vitro characterization of phage showed it resistant Enterococcus faecium [6] and methicillin-resistant was able to multiply very rapidly on a P. A report on the treatment of single on the morphology the phage is tentatively placed in the cases of human burns, wounds indicates that bacteriophage Siphoviridae family [25]. In contrast, nondiabetic bacteremic Hence, in the present work, an observational evaluation mice were rescued even when treatment was delayed up to of the healing potential of newly isolated bacteriophage in 20 h afer lethal bacterial challenge. BioMed Research International 9 (a) (b) (c) (d) Figure 7: Histopathology of the liver. Te with earlier studies which showed a marked diference in survival rate between phage treated and the control groups the efect of phage therapy was observed in groups treated is statistically signifcantly diferent. It is well teremic mice by delaying treatment was reduced, suggesting known that drugs are catabolized and removed from the that stressed animals are more sensitive to various factors; in body (half life span), whereas phage keeps on multiplying this case either the phage itself or trace amounts of endotoxins until all host bacteria are followed in the circulation and and exotoxins are present in the phage preparations. It has been reported that a small animals did not display apparent reactions to these factors, population of mutant I phage survived in the circulation, as evidenced by the lack of any adverse efects in the control with a concomitant alteration to major head protein E [8]. Similar fndings comparison of the outcome of treatment of diabetic and non- were reported in the treatment of P. Histological analysis confrmed that the organ Evaluation of results confrmed that a single intraperitoneal damage in the treated group was less severe than in the antibi- injection of the phage dose was more efcacious than the otic and untreated animals. Te reduction in bacterial load severe impairment in most critical organs, especially the liver was refected in the lower morbidity and mortality observed and spleen in the mice treated with antibiotic and untreated 10 BioMed Research International (a) (b) (c) (d) Figure 8: Histopathology of the lung. Karchmer, targets extracellular bacteria and also the role of phagocytosis “Infections in patients with diabetes mellitus,” New England in bacterial removal [30]. Ferreira,“Experi- mental model of induction of diabetes mellitus in rats,” Acta Cirurgica Brasileira,vol.

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In hemolytic anemia discount primaquine 15mg without prescription, it is decreased in urine in obstructive jaundice (cholestatic disease) buy generic primaquine 15mg online. Other drugs that exposed to daylight cause cholestasis cheap primaquine 15 mg, such as chlorpromazine trusted primaquine 15mg, increase the B. Bilirubin excretion is increased by in the form of diglucuronide, some monoglucuronide chlorpromazine and other glycosides are excreted. Bilirubin is excreted only as the diglucuronide transferase deficiency, some bilirubin is excreted as sulfatides. Chemistry/Evaluate laboratory data to recognize problems/Bilirubin/2 218 Chapter 5 | Clinical Chemistry 56. Which condition is caused by deficient secretion of Answers to Questions 56–59 bilirubin into the bile canaliculi? Crigler–Najjar syndrome accumulation of conjugated bilirubin that is not secreted into the bile canaliculi. Total and direct Chemistry/Correlate laboratory data with physiological bilirubin are elevated, but other liver function is processes/Bilirubin/2 normal. In hepatitis, the rise in serum conjugated bilirubin condition that also results in retention of conjugated can be caused by: bilirubin. Enzymatic conversion of urobilinogen to from Dubin–Johnson syndrome by the pattern of bilirubin urinary coproporphyrin excretion and because it D. B Conjugated bilirubin is increased in hepatitis and processes/Bilirubin/2 other causes of hepatic necrosis due to failure to 58. Which of the following is a characteristic of re-excrete conjugated bilirubin reabsorbed from obstructive jaundice? Te ratio of direct to total bilirubin is greater attributed to accompanying intrahepatic obstruction, than 1:2 which blocks the flow of bile. A Obstruction prevents conjugated bilirubin from unconjugated bilirubin is normal reaching the intestine, resulting in decreased C. Conjugated bilirubin regurgitates into Chemistry/Correlate clinical and laboratory data/ sinusoidal blood and enters the general circulation Bilirubin/2 via the hepatic vein. A Conjugated bilirubin increases as a result of Chemistry/Correlate clinical and laboratory data/ obstructive processes within the liver or biliary Bilirubin/2 system or from failure of the enterohepatic circulation. Hemolytic anemia (prehepatic jaundice) presents a greater bilirubin load to a normal liver, resulting in increased bilirubin excretion. When the rate of bilirubin formation exceeds the rate of excretion, the unconjugated bilirubin rises. Type 2 is an autosomal dominant trait Chemistry/Apply knowledge of fundamental biological and is characterized by lesser jaundice and usually characteristics/Bilirubin/1 the absence of kernicterus. Which statement regarding total and direct controlled with phenobarbital, which promotes bilirubin levels is true? Total bilirubin level is a less sensitive and specific autosomal recessive condition characterized by marker of liver disease than the direct level decreased bilirubin uptake and decreased formation B. Dubin–Johnson and Rotor syndromes are in hemolytic anemia autosomal recessive disorders associated with Chemistry/Correlate clinical and laboratory defective delivery of bilirubin into the biliary system. Which statement best characterizes serum specific marker for hepatic and posthepatic jaundice bilirubin levels in the first week following delivery? Serum bilirubin 24 hours after delivery should hemolytic anemia, the total bilirubin does not exceed not exceed the upper reference limit for adults 3. Unconjugated bilirubin is the major fraction in postpartum in neonatal hyperbilirubinemia necrotic liver disease because microsomal enzymes C. Unconjugated bilirubin is elevated along 2–5 days after delivery indicates hemolytic or with direct bilirubin in cholestasis because some hepatic disease necrosis takes place and some conjugated bilirubin is D. Conjugated bilirubin accounts for about 50% of hydrolyzed back to unconjugated bilirubin. B Bilirubin levels may reach as high as 2–3 mg/dL in Chemistry/Correlate clinical and laboratory data/ the first 24 hours after birth owing to the trauma of Bilirubin/2 delivery, such as resorption of a subdural hematoma. Neonatal bilirubin is Chemistry/Correlate clinical and laboratory data/ almost exclusively unconjugated. B Lucey–Driscoll syndrome is a rare form of jaundice caused by unconjugated bilirubin that presents within 2–4 days of birth and can last several weeks. A lab measures total bilirubin by the Answers to Questions 64–67 Jendrassik–Grof bilirubin method with sample blanking. Falsely increased due to optical interference formation and corrects the measurement for optical B. Falsely low due to inhibition of the diazo is an inhibitor of the diazo reaction and will cause reaction by hemoglobin falsely low results in a blank corrected sample. No effect due to correction of positive reason, direct bichromatic spectrophotometric interference by sample blanking methods are preferred when measuring bilirubin in neonatal samples, which are often hemolyzed. C A polarity modifier is required to make unconjugated bilirubin soluble in diazo reagent. Which reagent is used in the Jendrassik–Grof method uses 50% methanol to reduce the polarity method to solubilize unconjugated bilirubin? B Unconjugated bilirubin is poorly soluble in acid, and therefore, direct bilirubin is assayed using diazotized 66. Direct bilirubin must react with diazo reagent 3 minutes to prevent reaction of unconjugated under alkaline conditions bilirubin, or the diazo group can be reduced using B. Most methods are based upon reaction with ascorbate or hydroxylamine preventing any further diazotized sulfanilic acid reaction. Te color of the azobilirubin product is for the measurement of direct bilirubin because independent of pH unconjugated bilirubin is poorly soluble at low pH. Total bilirubin is measured using an acetate buffer Chemistry/Apply principles of basic laboratory with caffeine added to increase the solubility of the procedures/Bilirubin/1 unconjugated bilirubin. Which statement regarding the measurement of sulfanilic acid and incubatiion, the diazo group is bilirubin by the Jendrassik–Grof method is reduced by ascorbic acid, and Fehling’s reagent is correct? Te same diluent is used for both total and direct product changes from pink to blue, shifting the assays to minimize differences in reactivity absorbance maximum to 600 nm where Hgb does B. Positive interference by Hgb is prevented by the not contribute significantly to absorbance. Te color of the azobilirubin product is intensified by the addition of ascorbic acid D. Fehling’s reagent is added after the diazo reaction to reduce optical interference by hemoglobin Chemistry/Apply principles of basic laboratory procedures/Bilirubin/2 5. A neonatal bilirubin assay performed at the Answers to Questions 68–70 nursery by bichromatic direct spectrophotometry is 4. A The Jendrassik–Grof method is based upon a diazo assayed for total bilirubin by the Jendrassik–Grof reaction that may be suppressed by Hgb. Both samples serum blanking and measurement at 600 nm correct are reported to be hemolyzed. What is the most for positive interference from Hgb, the results may likely explanation of these results? A commonly used approach is to direct bilirubin measure absorbance at 454 nm and 540 nm.

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As opposed to the muscle injuries that occur in the rest of the upper extremity effective primaquine 15 mg, soft tissue injuries around the wrist and hand tend to involve injuries to the tendons cheap 15 mg primaquine visa. Cut tendon ends often can be identified in an emergency setting and primarily repaired with good results generic primaquine 15mg. In contrast discount 15 mg primaquine, flexor tendon injuries tend to be avul- sions of the flexor tendons from their distal insertions and usually are the result of forced extension of the finger while the finger flexor is con- tracting. These injuries usually require surgical intervention with meticulous surgical technique. Poor handling of the flexor tendons during surgical repair can result in excessive scar formation and sig- nificant loss of finger motion. Dislocations of the wrist usually are the result of a fall onto an out- stretched hand. Despite the significant trauma to the wrist, this injury is missed in the emergency setting. There is certainly diffuse soft tissue swelling and pain as a result of the injury, but radiographic evaluation of the injury can be confusing. However, careful evaluation of a lateral radiograph of the wrist documents the injury (Fig. Either the lunate is dislocated in a volar direction and the capitate appears to articulate with the distal radius, or the lunate maintains its articulation with the distal radius and the capitate and the rest of the carpus have dislocated in a dorsal direction. This injury results in significant pres- sure on the median nerve as it passes through the carpal tunnel; it requires prompt treatment and almost always requires open reduc- tion and internal fixation due to the multiple ligament injuries that occur between the various carpal bones. More common dislocations involve the metacarpocarpal joints, the metacarpophalangeal joints, and the interphalangeal joints. Many of these dislocations can be treated with closed reduction with longitudinal traction, and main- tained with appropriate positioning of the hand. The carpometacarpal dislocations usually require cast treatment to maintain the reduction. Dislocations of the metacarpophalangeal joints and the interphalangeal joints usually require only minimal immobilization, followed by restoration of motion. Fractures of the distal radius are one of the most commonly encoun- tered injuries. Although a Colles’ fracture describes a comminuted fracture of the distal radius that extends to the articular surface and includes a fracture of the ulnar styloid, the term commonly is used to describe all distal radius fractures. The typical patient with a distal radius fracture is an elderly woman with osteoporosis who has fallen onto her outstretched hand. In these injuries, the distal fragment usually is displaced dorsal relative to the proximal fragment, and the clinical deformity associated with this injury sometimes is referred to as a silver-fork deformity. The majority of these injuries can be treated with a closed reduction and cast immobilization. In the younger patient who sustains a high-energy injury with significant disruption of the articular surface, surgical intervention is required. Fracture of the scaphoid is another injury that occurs as a result of a fall onto an outstretched hand. However, the patient tends to have ten- derness in the anatomic snuffbox to palpation. If a scaphoid fracture is suspected, radiographs should be inspected carefully, since up to 20% of these injuries are not diagnosed at the initial evaluation. If the clinical examination is consistent with a scaphoid fracture and the initial radiographs do not demonstrate a fracture, the patient should be immobilized in a thumb spica splint and follow-up should be arranged, since radiographic evidence of the injury may not be present until 2 to 3 weeks after the injury. This injury does have a high incidence of nonunion, especially if the injury is not immobilized in the early stages or if there is displacement of the fracture. A fracture of the fifth metacarpal neck is referred to as a boxer’s fracture and usually occurs as a result of the patient’s striking a hard object with a clenched fist. This particular injury should be inspected carefully for a laceration over the head of the metacarpal. The laceration can be the result of the clenched fist hitting the tooth of another person. Consequently, this par- ticular injury is at significant risk for infection and requires thorough 33. This injury presents with apex dorsal angulation at the level of the metacarpal neck distally, and this almost always can be successfully reduced and held in good position with cast immobilization. In the poste- rior aspect, the sacrum, which contains the distal spinal nerve roots, articulates with the ilium on either side. The hip joint is formed by the articulation between the head of the proximal femur and the acetabulum. In con- trast to the “ball and socket” joint of the shoulder, the round head of the femur is well contained in the deep socket of the acetabulum. In sports events, high-energy direct blows to the anterior thigh can lead to quadriceps contusions and hematomas. This particular injury can be very painful and lead to a very tense-appearing thigh. The size of the hematoma formation can be controlled by early splinting of the leg with the knee held in hyperflexion, putting the quadriceps muscle on stretch. Since myositis ossificans at the site of the quadriceps injury is a troublesome sequela, minimizing the size of the hematoma formation is beneficial. Another sports-related injury that often has a dramatic presentation is avulsion of the sartorius muscle from the anterosuperior iliac spine or avulsion of the rectus femoris from the anteroinferior iliac spine. In either of these injuries, patients report feeling a pop in their hip and present with significant pain with ambulation. However, palpation over the appropriate iliac spine helps diagnose the site of the injury. Dislocations of the hip joint usually are caused by high-energy trauma, such as a motor vehicle accident or a fall from a height, although they can occur in sporting injuries. The most common dis- location is a posterior dislocation of the femoral head from the acetabulum. In this case, the patient presents with the hip flexed, adducted, and internally rotated. When the dislocation is anterior, the patient presents with the hip held in abduction, flexion, and external rotation. Prior to reduction, a neurovascular examination should be performed with attention paid to sciatic nerve function, since this nerve can be injured, especially with posterior dislocations. Radiographs should be evaluated for other associated injuries, such as acetabular wall fractures, femoral head fractures, or fractures of the femur. Reduction of hip dislocation usually requires some form of sedation, followed by application of longitudinal traction in line with the defor- mity. Once reduced, a repeat neurologic examination should be per- formed, again paying attention to the function of the sciatic nerve.

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The decision to treat with ciprofloxacin or a non-quinolone antibiotic was made prior to enrollment in the study and was based on the particular infection order 15 mg primaquine with mastercard, medical history and the clinical evaluation by the prescribing physician buy generic primaquine 15 mg on-line. After the investigator determined that a particular infant or child with an eligible infection was suitable for treatment with ciprofloxacin or a non-quinolone antibiotic order primaquine 15mg with visa, the selection of study unit dose buy primaquine 15 mg amex, total daily dose, duration of therapy, route of administration, and formulation (i. In general, ciprofloxacin or non-quinolone antibiotic therapy was to be administered for a minimum duration of 7 days and a maximum duration of 21 days. Interim safety results from the first year post-treatment are provided for 487 ciprofloxacin-treated patients and 507 non-quinolone control patients valid for safety analysis. The clinical success and bacteriologic eradication rates in the Per Protocol population at 5 to 9 days following the end of therapy (i. Clinical cure rates and bacteriological eradication rates were not substantially impacted by age, race, or sex of the patient. Study 100201 This was a safety study and therefore did not have any clinical or microbiological efficacy criteria. All cases were reviewed in a blinded fashion, and were judged as either having no evidence of clinically diagnosed arthropathy, or as having at least possible evidence of arthropathy. This definition included events such as bursitis, enthesitis (inflammation of the muscular or tendinous attachment to the bone) and tendonitis. Arthropathy occurred more frequently in patients who received ciprofloxacin than the comparator and was defined as any condition affecting a joint or periarticular tissue that may have been temporary or permanent (including bursitis, inflammation of the muscular or tendinous attachment to the bone, and tendonitis). All musculoskeletal events occurring by 6 weeks resolved, usually within 30 days of end of treatment. Ciprofloxacin patients were more likely to report more than one event and on more than one occasion compared to control patients (37% [17/46] versus 24% [8/33]). Of the 46 patients with arthropathy in the ciprofloxacin arm, radiological testing of the affected joint was reported for 9 patients. X-ray results were negative in 6 patients and included: hip for abnormal gait (Patient 301213), lumbosacral area for lumbar pain (302026), hips and spinal cord for back pain and thoracic spine pain (307004), leg (i. One patient had an X-ray of both knees (307015) for pain and swelling and the findings were “bilateral genu valgum”, which was a pre-existing condition for that patient. Another patient (16001) had an ankle X-ray for pain which showed “lateral soft tissue swelling, no radiological evidence of definite osseous abnormality. Of the 33 comparator patients, one patient (37001) had an X-ray for ankle pain and the results were negative. Another patient (401047) had an X-ray of both knees performed for oligoarthralgia, which was also negative. At both evaluations, the 95% confidence interval indicated that it could not be concluded that ciprofloxacin had findings comparable to the comparator. The arthropathy rates were similar between males and females and consistent between treatment groups. Arthropathy rates were lower than the overall study rates in Mexico (0% for both ciprofloxacin [0/56] and comparator [0/60], respectively) and Peru (2. There was a bigger difference between treatment group arthropathy rates in the United States (21. Neurological Events The incidence of neurological events from initial dosing through 6 weeks up follow-up was 2. All events were reported in less than 1% of patients in either treatment group, as shown in Table 3. The most frequently reported events were gastrointestinal: 15% (50/335) of ciprofloxacin patients compared to 9% (31/349) of control patients. Adverse events, other than those affecting the musculoskeletal or neurologic systems, that occurred in at least 1% of patients treated with ciprofloxacin by six weeks included: diarrhea 4. Study 100201 Patients were treated for various infections, most commonly otitis media (29% [143/487]) and urinary tract infection (22% [105/487]). They had a variety of underlying diseases, including malignancies, and were receiving multiple concomitant medications. Of note, an adolescent female in the ciprofloxacin treatment arm discontinued study drug after 7 days for wrist pain that developed after 3 days of treatment. A diagnosis of overuse syndrome secondary to sports activity was made, but a contribution from ciprofloxacin cannot be excluded. The incidence of any investigator-reported musculoskeletal adverse event by the 1-year post-treatment follow-up in 487 ciprofloxacin-treated patients was 13% (64 patients). The incidence of any neurologic event by 6 weeks of follow-up in ciprofloxacin­ treated patients was 7. Earlier hospital discharge or avoidance of hospital admission could become options for more patients, which in turn holds the potential to improve their quality of life. Myalgia is less frequently reported, but also found in a few case reports in the published literature. These safety concerns and the subsequent restriction of the use of fluoroquinolones in pediatric patients emanated from findings of cartilage damage in the weight- bearing joints of juvenile experimental animals. To date, there is little evidence that fluoroquinolone-associated arthropathy as described in experimental animals 1 correlates with the same phenomenon in humans. Fluoroquinolone-associated arthropathy in children has been described in the literature as a separate clinical phenomenon, distinct from that observed in laboratory animals and without damage 2 to cartilage. The available clinical information describing joint toxicity in humans comes largely from case reports, compassionate-use protocols, and worldwide clinical safety 3-6 databases. A large proportion of the patients included in these studies and reports 8 had cystic fibrosis, which may itself be associated with arthropathy. Tendinopathy appears to be a more significant adverse event associated with fluoroquinolone therapy that can 12 result in tendon rupture. Fluoroquinolone-associated tendinopathy appears to be more common in patients with tendons under high stress, and may pose a risk to those who 13,14 participate in sports or exercise. Other risk factors also have been identified, 15 including age, concomitant steroid therapy, and renal disease. The incidence of neurological side effects such as seizures, hallucinations, tremor, restlessness, dizziness, and headache was reported as approximately 0. Severe central nervous system adverse events such as psychotic reactions, hallucinations, depressions and grand mal convulsions occur at an incidence of less than 0. The primary objective of the studies included in the Written Request was to evaluate the long-term musculoskeletal and neurologic adverse events in pediatric patients (1 to 17 years) who received ciprofloxacin therapy. The current application was submitted in response to the Written Request issued September 23, 2003. It consists of two clinical trials in pediatric patients, a population pharmacokinetic analysis, and an animal toxicology study. Effective therapeutic intervention for children presenting with pyelonephritis is necessary because there may be a correlation between the degree of scarring and renal damage resulting from an infection when it is inappropriately treated.

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