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Dysuria in Children

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181. Suprapubic urinary catheter

record ( ). The child’s doctor must be informed if the child: is unable to pass urine ( ) has dysuria ( ) if the entry site leaks on their first micturition The entry site must be observed for haemorrhage and urine leakage ( ). If either occurs, pressure must be applied and the child’s doctor informed ( ). The dressing should be removed after 24 hours ( ). Once the site is healed a dressing will no longer be required. The appropriate children’s community nursing team must be informed on admission (...) ( ) Suprapubic catheterisation must only be performed when absolutely necessary and be for the minimum possible time, usually three to 28 days. However, long-term use is suitable for some children ( ). Suprapubic catheters must always be managed using a non-touch technique ( ). It is recommended that all catheters and securing devices are latex free ( ). The child may experience discomfort from the catheter, even if it is the correct size and correctly positioned. Analgesia should be given as prescribed

2014 Publication 1593

182. Xigduo - dapagliflozin / metformin

) of Directive 2001/83/EC – relating to applications for new fixed combination products. The application submitted is a new fixed combination medicinal product, composed of administrative information, complete quality data, non-clinical and clinical data based on applicants’ own tests and studies and/or bibliographic literature substituting/supporting certain tests or studies. Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006, the application included an EMA

2014 European Medicines Agency - EPARs

183. Dapagliflozin (Farxiga)

, MPH NDA 202293; FARXIGA (dapagliflozin) 4 7.5.5 Drug-Drug Interactions 124 7.6 Additional Safety Evaluations 124 7.6.1 Human Carcinogenicity 124 7.6.2 Human Reproduction and Pregnancy Data 124 7.6.3 Pediatrics and Assessment of Effects on Growth 124 7.6.4 Overdose, Drug Abuse Potential, Withdrawal and Rebound 124 7.7 Additional Submissions / Safety Issues 125 8 POSTMARKET EXPERIENCE 125 9 APPENDICES 126 9.1 Literature Review/References 126 9.2 Labeling Recommendations 128 9.3 Advisory Committee (...) Pharmacodynamics SOC System Organ Class PDUFA Prescription Drug User Fee Act ST Short-Term PeRC Pediatric Research Committee SU Sulfonylurea PK Pharmacokinetics T1DM Type 1 Diabetes Mellitus Reference ID: 3426720Clinical Review Frank Pucino, PharmD, MPH NDA 202293; FARXIGA (dapagliflozin) 8 PPG Post Prandial Glucose T2DM Type 2 Diabetes Mellitus PREA Pediatric Research Equity Act TBL Total Bilirubin PT Preferred Term TCC Transitional Cell Carcinomas PVD Peripheral Vascular Disease TEAE Treatment-Emergent

2014 FDA - Drug Approval Package

184. Triumeq - abacavir/dolutegravir/lamivudine (ABC/DTG/3TC)

creatinine compared to baseline values were performed. SINGLE Overall, throughout the 96-week treatment period, the incidence of renal related AEs (regardless of severity, causality) was 6% in the DTG group vs. 7% in the Atripla group. The event rates at Week 48 were 4% and 5% in the DTG and Atripla treatment arms, respectively. By preferred terms, the most common AE (regardless of severity, causality) at Week 96 was dysuria (1% in each arm). Other AEs reported in at least 2 subjects receiving DTG (...) for Postmarketing Risk Evaluation and Management strategies No postmarketing risk management activities are required for this application. Recommendation for other Postmarketing Requirements and Commitments The following PMRs are recommended: 1. Deferred pediatric trial under PREA for the treatment of HIV-1 infection in pediatric subjects from 12 to <18 years of age. Evaluate the safety and antiviral activity of ABC/DTG/3TC FDC in pediatric subjects with safety and virologic response assessed over at least 24

2014 FDA - Drug Approval Package

185. Ureteric stent

perform a hand wash and dry hands thoroughly record the procedure and volume of urine in the child’s health records ( ) The child and family must be reminded that pain may be experienced as the kidney pelvis fills up and during the first micturition. The child’s first micturition must be documented on the fluid balance chart and in the child’s health care record ( ). The child's doctor must be informed if the child: is unable to pass urine ( ) has dysuria or loin pain if the entry site leaks (...) on their first micturition ( pressure should be applied) ( ) The dressing should be removed after 24 hours ( ). O nce the site is healed a dressing will no longer be required. Discharge The child’s parents should be advised to contact the ward if, once discharged, they have concerns about the wound site ( ). The family must be told to contact the ward if the child experiences any of the following problems: if the child is unable to pass urine ( ) the child has dysuria or loin pain ( ) Rationale Rationale 1

2014 Publication 1593

186. New Zealand Guideline for the Management of Gonorrhoea

Partner notification 39 Management of sexual partners/contacts 39 Management of gonorrhoea in children 40 Testing for N. gonorrhoeae in prepubertal children 40 When should N. gonorrhoeae testing be undertaken in prepubertal children? 41 Which specimens should be taken, and which tests should be requested? 41 Additional testing 42 Gonorrhoea typing 42 NAAT 42 Management of gonorrhoea in prepubertal children (excluding neonates) 42 For uncomplicated anogenital and pharyngeal gonorrhoea (not in neonates (...) , gonorrhoea is the second most common bacterial STI after chlamydia. The primary sites of infection are the urethra, rectum, pharynx and conjunctiva in both genders and the endocervix in the female. In infants, the conjunctiva is the most common site of infection. N. gonorrhoeae has traditionally been detected by culture, before measurement of antibiotic susceptibilities. This method is highly specific for N. gonorrhoeae but is time consuming and subjective, and it relies on organism viability, which

2014 New Zealand Sexual Health Society

187. UK National Guidelines on the Management of infection with Chlamydia Trachomatis

Clinical Features The majority of individuals with chlamydial infection are asymptomatic. 24 However symptoms and signs include the following: Women Symptoms: - Increased vaginal discharge - Post-coital and intermenstrual bleeding - Dysuria - Lower abdominal pain 8 - Deep dyspareunia Signs: - Mucopurulent cervicitis with or without contact bleeding - Pelvic tenderness - Cervical motion tenderness Men Symptoms (may be so mild as to be unnoticed): - Urethral discharge - Dysuria Signs: - Urethral (...) be considered in all infants who develop conjunctivitis within 30 days of birth. 130 In view of the fact that infection may occur at multiple sites, oral therapy is recommended. Diagnosis of neonatal chlamydia infection The diagnosis is most frequently made on clinical grounds, as the results of tests are not routinely immediately available. Although NAAT testing is not validated, its widespread use in the diagnosis of rectal and pharyngeal infection in adults suggests that it should be effective

2015 British Association for Sexual Health and HIV

188. UroLift for treating lower urinary tract symptoms of benign prostatic hyperplasia

noted no cases of urinary incontinence or sexual dysfunction. Minor complications included transient dysuria (70%) and urgency (40%), and slight haematuria (30%). Two patients (10%) needed post-operative catheterisation. The authors stated that longer follow-up times and larger patient numbers were needed before conclusions could be made on the safety and efficacy of the technology. An average of 3.8 UroLift implants was used per patient. 3.11 Chin et al. (2012) and Woo et al. (2012) both reported (...) reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 11 of 35some patients continued to show a 34% symptomatic improvement. Similar improvements were shown in BPHII and quality of life. Results were statistically significant for all of these outcomes at all time intervals. No decrease in sexual function was observed, and the MSHQ-EjD showed significant improvements at some intervals. Adverse events were minor, such as dysuria and haematuria

2015 National Institute for Health and Clinical Excellence - Medical technologies

189. Neuro-urology

. Complications of neuro-urological symptoms (infections) account for a major cause of mortality in MSA [31]. Brain tumors 26.8/100,000/yr in adult (> 19 yrs) (17.9 benign, 8.9 malignant) [32]. Neuro-urological symptoms vary according to tumour location. Incontinence occurs mainly in frontal location (part of frontal syndrome or isolated in frontal location) [33]. Voiding dyfunction may occur in other location. Mental retardation and cerebral palsy Intellectual disability in children is a very heterogenous (...) group: including perinatal injury, materno- foetal infections, metabolic disease, genetic disorders and cerebral palsy Mental retardation other than cerebral palsy Cerebral Palsy: 3.1-3.6/1,000 in children aged 8 yrs [34]. Incontinence: In 65% of severe and profoundly retarded adult patients [35, 36]. DO and impaired contractility also reported. 89% incontinence, 70% uninhibited detrusor contraction at urodynamic examination. Recurrent urinary tract infection and radiologic abnormalities in > 10

2015 European Association of Urology

190. Urological Infections

measures 29 3E.5.2 Treatment 30 3E.5.2.1 Relief of obstruction 30 3E.5.2.2 Antimicrobial therapy 30 3E.5.2.3 Adjunctive measures 31 3F CATHETER-ASSOCIATED UTIs 31 3F .1 Introduction 31 3F .2 Methods 31 3F .3 Classification systems 31 3F .4 Diagnostic evaluation 32 3F .5 Disease management 32 3F .6 Summary of recommendations 32 3G UTIs IN CHILDREN 33 3G.1 Introduction 33 3G.2 Epidemiology, aetiology and pathophysiology 34 3G.3 Classification systems 34 3G.4 Diagnostic evaluation 35 3G.4.1 Physical (...) ). These Guidelines cover male and female UTIs, male genital infections and special fields such as UTIs in paediatric urology and risk factors, e.g. immunosuppression, renal insufficiency and diabetes mellitus. Much attention is given to peri-operative antibacterial prophylaxis (ABP), aiming to reduce the overuse of antimicrobial agents in conjunction with surgery. High quality clinical research using strict internationally recognised definitions and classifications, as presented in these Guidelines

2015 European Association of Urology

191. Urological Trauma

Trauma prepared these guidelines in order to assist medical professionals in the management of urological trauma in adults. Paediatric trauma is addressed in the EAU Paediatric Urology Guidelines. 1.2 Panel composition The EAU Urological Trauma Guidelines Panel consists of an international group of clinicians with particular expertise in this area. 1.2.1 Potential conflict of interest The expert panel have submitted potential conflict of interest statements which can be viewed on the EAU website. 1.3 (...) violence, child and sexual abuse, and MVAs [8]. 3.1.1 Genito-Urinary Trauma Genito-urinary trauma is seen in both sexes and in all age groups, but is more common in males. The kidney is the most commonly injured organ in the genito-urinary system and renal trauma is seen in up to 5% of all trauma cases [9, 10], and in 10% of all abdominal trauma cases [11]. In MVAs, renal trauma is seen after direct impact into the seatbelt or steering wheel (frontal crashes) or from body panel intrusion in side-impact

2015 European Association of Urology

194. A Randomized Control Trial Comparing Outcome after Stented and Nonstented Anderson-Hynes Dismembered Pyeloplasty. Full Text available with Trip Pro

A Randomized Control Trial Comparing Outcome after Stented and Nonstented Anderson-Hynes Dismembered Pyeloplasty. The aim of the study was to compare the efficacy and postoperative complications of stented and nonstented open pediatric dismembered pyeloplasty for ureteropelvic junction (UPJ) obstruction.A balanced, parallel group, prospective randomized controlled trial comparing stented and nonstented Anderson-Hynes Dismembered Pyeloplasty.It included 42 children who required Anderson-Hynes (...) dismembered pyeloplasty for UPJ obstruction (UPJO). Patients were randomized into stented (double "J" [DJ] stent) and nonstented pyeloplasty groups. The intraoperative and postoperative course was compared. Both groups were analyzed for problems such as dysuria, frequency, pain, hematuria and urinary tract infection, and postoperative renal status.Mann-Whitney U-test, Fisher's exact test, Student's t-tests, and Chi-squared test were used.Surgical duration was significantly shorter for the nonstented group

2019 Journal of Indian Association of Pediatric Surgeons Controlled trial quality: uncertain

196. Vaginal Cancer Treatment (PDQ®): Health Professional Version

Summaries [Internet]. Bethesda (MD): National Cancer Institute (US); 2002-. Version History NBK65801.8 November 15, 2019 (Displayed Version) February 7, 2019 February 6, 2018 January 30, 2018 February 9, 2017 January 26, 2017 February 9, 2016 July 15, 2015 In this Page Related publications Related information Links to PubMed Similar articles in PubMed [PDQ Cancer Information Summari...] Review Childhood Cervical and Vaginal Cancer Treatment (PDQ®): Health Professional Version PDQ Pediatric Treatment (...) third of the vagina. In women who had not previously undergone hysterectomy, upper vaginal lesions were found in 17 of 50 women (34%). Clinical Features Although early vaginal cancer may not cause noticeable signs or symptoms, possible signs and symptoms of vaginal cancer include the following: Metrorrhagia. Dyspareunia. Pelvic pain. Vaginal mass. Dysuria. Constipation. Diagnostic Evaluation The following procedures may be used to diagnose vaginal cancer: History and physical exam. Pelvic exam

2017 PDQ - NCI's Comprehensive Cancer Database

197. Perjeta - pertuzumab

, complete quality data, non- clinical and clinical data based on applicants’ own tests and studies and/or bibliographic literature substituting/supporting certain test(s) or study(ies). Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006, the application included an EMA Decision P/345/2010 on the granting of a class waiver. Information relating to orphan market exclusivity Similarity Pursuant to Article 8 of Regulation (EC) No. 141/2000 and Article 3

2013 European Medicines Agency - EPARs

198. Dalbavancin hydrochloride (HCl) (Dalvance)

currently breastfeeding an infant. 3. Patients with sustained shock, defined as systolic blood pressure 8 µg/mL). 7. Patients with evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis; endovascular infection, such as clinical and/or echocardiographic evidence of endocarditis or septic thrombophlebitis. 8. Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone

2013 FDA - Drug Approval Package

199. Candida - female genital

(usually white, 'cheese-like', and non-offensive), superficial dyspareunia, and dysuria. Signs may include vulvovaginal inflammation and erythema, vaginal fissuring, and excoriation of the vulva. Microscopy and fungal culture of vaginal secretions to identify yeasts is only recommended for supporting the diagnosis and in cases of severe or recurrent vulvovaginal candidiasis, or treatment failure. Treatment of uncomplicated infection involves: A short course of an intravaginal antifungal (...) (usually white, 'cheese-like', and non-malodorous). Superficial dyspareunia. Dysuria (pain or discomfort during urination). Enquire whether the infection is: An isolated episode, or A recurrence (defined as four or more documented episodes in 1 year, with at least partial resolution of symptoms between episodes), or Treatment failure (failure of symptoms to resolve within 7–14 days of treatment). Ask about any treatments that have been tried already, including over-the-counter treatments. Enquire about

2017 NICE Clinical Knowledge Summaries

200. Herpes simplex - genital

difference in power or mental capacity between the young person and their sexual partner, in particular when the relationship is incestuous or with a person in a position of trust (such as a teacher, sports coach, minister of religion) or there is concern that the young person is being exploited. If child maltreatment is suspected, refer the young person to children's social care, following Local Safeguarding Children Board procedures. Basis for recommendation Basis for recommendation (...) are usually bilateral and develop 4–7 days after exposure to HSV infection. People may complain of dysuria, vaginal or urethral discharge, and systemic symptoms such as fever and malaise. A primary episode can last up to 20 days, and is often more severe than a recurrent episode. Following primary infection, the virus becomes latent in local sensory ganglia. Recurrent genital herpes refers to a recurrence of clinical symptoms due to reactivation of pre-existent HSV infection after a latent period. People

2017 NICE Clinical Knowledge Summaries

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