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Dysuria in Children

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141. Point-of-care testing for urinary tract infections

by Anacleto et al., 26 the authors compared the accuracy of the Uricult Trio device against conventional urine microscopy and culture. They tested 198 mid-stream clean-catch, randomly voided (i.e. urine collected at any point in the stream) or catheterized urine samples from children aged 0-7 if the sample had been screened positive for nitrites or leukocyte esterase with a urine dipstick test. A urine sample was obtained from children 2 years of age if they presented with dysuria, urgency, flank pain (...) when using the cut-off value of >5×10 4 CFU/ml. The lower accuracy of the study can be explained to a degree by the higher cut-off value for significant bacteriuria. Paediatric patients 6. Waisman et al. 35 tested the diagnostic accuracy of Uriscreen® compared to urine culture in early detection of UTIs in urine specimens obtained through midstream void technique, bladder catheterization, or suprapubic aspiration from children aged 1 month to 17 years of age. The study was conducted over a period

2016 Publication 4878904

142. Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals ? protocol version 5.3

-producing C. difficile organisms in stool. ? SYS-CSEP: no change in the definition, but change of the name from ‘clinical sepsis’ to ‘treated unidentified severe infection’ in adults and children, to differentiate this last-resort HAI case definition from the modern concept of sepsis based on organ dysfunction. TECHNICAL DOCUMENT PPS of HAIs and antimicrobial use in European acute care hospitals – protocol version 5.3 3 Objectives The objectives of the ECDC point prevalence survey of healthcare (...) on maternity and paediatric wards if born before/at 8 a.m. (see also under neonates). Exclude day cases: ? patients undergoing same day treatment or surgery; ? patients seen at outpatient department; ? patients in the emergency room; ? dialysis patients (outpatients). Note: Decision to include/exclude patients is based on information available at 8 a.m. on the day of the survey. Figure 1. Examples of included and excluded patients in the point prevalence survey Legend. W1: ward 1, W2: ward 2 Note: Include

2016 European Centre for Disease Prevention and Control - Technical Guidance

143. Edistride - dapagliflozin

this medicine. Pediatric population Product labeling: Posology and method of administration: Paediatric population The safety and efficacy of dapagliflozin in children aged 0 to < 18 years have not yet been established. No data are available. Patient information Children and adolescents Forxiga is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients. Not applicable Pregnancy / Nursing mothers Product labeling: Fertility, pregnancy (...) 82.1 of Regulation (EC) No 726/2004. Information on Paediatric requirements Not applicable Similarity Pursuant to Article 8 of Regulation (EC) No. 141/2000 and Article 3 of Commission Regulation (EC) No 847/2000, the applicant did not submit a critical report addressing the possible similarity with authorised orphan medicinal products because there is no authorised orphan medicinal product for a condition related to the proposed indication. Licensing status The cross-referred product Forxiga

2015 European Medicines Agency - EPARs

144. Ebymect - dapagliflozin / metformin

: Warnings and precautions If you are 75 years old or older, you should not start taking this medicine. This is because you may be more prone to some side effects. If you are taking another medicine for diabetes that contains “pioglitazone”, you should not start taking this medicine. Not applicable Pediatric population Product labeling: Posology and method of administration: Paediatric population The safety and efficacy of Xigduo in children aged 0 to < 18 years have not yet been established. No data (...) of dapagliflozin and metformin as separate tablets. The legal basis for this application refers to: Article 10(c) of Directive 2001/83/EC – relating to informed consent from a marketing authorisation holder for an authorised medicinal product. The application submitted is composed of administrative information, quality, non-clinical and clinical data with a letter from AstraZeneca AB allowing the cross reference to relevant quality, non-clinical and/or clinical data. Information on Paediatric requirements

2015 European Medicines Agency - EPARs

145. Zerbaxa - ceftolozane / tazobactam

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 Decision P/0126/2014 on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP P/0126/2014 was not yet completed as some (...) should be administered at the earliest possible time following completion of haemodialysis) *CrCL estimated using Cockcroft-Gault formula **All doses of Zerbaxa are administered intravenously over 1 hour and are recommended for all indications. The duration of treatment should follow the recommendations in Table 1. Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see section 5.2). Paediatric population The safety and efficacy of ceftolozane/tazobactam

2015 European Medicines Agency - EPARs

146. Xydalba - dalbavancin

that Dalbavancin was considered to be a new active substance. The application submitted is 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 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(s) P/0245/2013 on the agreement of a paediatric investigation

2015 European Medicines Agency - EPARs

147. Senshio - ospemifene

. The applicant indicated that ospemifene was considered to be a new active substance (refer to sections on New active Substance status for further information). The application submitted is 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 (...) , a feeling of pressure and bleeding (particularly associated with sexual activity). VVA is also associated with urinary symptoms including urethral discomfort, frequency, hematuria, urinary tract infection, dysuria, and stress incontinence (MacBride et. al., 2010). Over time these symptoms, especially dyspareunia, can lead to female sexual dysfunction and subsequent emotional distress. Despite the impact of VVA on women’s health, this condition is underdiagnosed and undertreated, with only an estimated

2015 European Medicines Agency - EPARs

148. Avibactam sodium / ceftazidime (Avycaz)

-Disease Interactions 145 7.5.5 Drug-Drug Interactions 145 7.6 Additional Safety Evaluations 145 7.6.1 Human Carcinogenicity 145 7.6.2 Human Reproduction and Pregnancy Data 146 7.6.3 Pediatrics and Assessment of Effects on Growth 146 7.6.4 Overdose, Drug Abuse Potential, Withdrawal and Rebound 147 7.7 Additional Submissions / Safety Issues 147 8 POSTMARKET EXPERIENCE 149 9 APPENDICES 151 9.1 Literature Review/References 151 9.2 Labeling Recommendations 151 9.3 Advisory Committee Meeting 153 REFERENCES (...) to recommend routine pharmacovigilance as a sufficient strategy for postmarket risk evaluation. 1.4 Recommendations for Postmarket Requirements and Commitments The Applicant submitted a deferral request with their initial pediatric study plan, which assumes that efficacy can be extrapolated from adult data for cIAI and cUTI in pediatric patients as young as 3 months of age. Pursuant to PREA requirements, an open-label single-dose trial to evaluate the pharmacokinetic, safety and tolerability of CAZ-AVI

2015 FDA - Drug Approval Package

149. Sepsis

with sepsis, particularly Staphylococcus aureus , Pseudomonas species, and Escherichia coli [ ; ]. In children, Neisseria meningitides and Haemophilus influenzae may also be involved [ ]. Rarely, fungal, viral, or parasitic infections are causative [ ]. In about one-third of people with sepsis, no causative pathogen is identified [ ]. About 80% of hospital-treated sepsis cases originate from community-acquired infection [ ]. Risk factors What are the risk factors? Risk factors for sepsis include : Infants (...) [ ]. The information that people with sepsis may have non-specific or non-localized clinical features is based on the experience and opinion of the NICE guideline development group [ ], the UK Sepsis Trust publication [ ], and expert opinion in review articles [ ; ]. Older children may present with a focus of infection, but infants often present with non-specific symptoms and signs, which can lead to late recognition of sepsis [ ; ]. The information that sepsis may present with hypothermia is based on the UK

2019 NICE Clinical Knowledge Summaries

150. Hypertension in pregnancy

. If an ACE inhibitor or AIIRA is stopped, first-line treatment is usually labetalol if not contraindicated. Alternative treatment is with methyldopa or nifedipine, taking into account the adverse effect profiles for the woman, fetus, and newborn infant. For labetalol, start with a dose of 100 mg twice a day. For methyldopa, start with a dose of 250 mg 2–3 times a day. For nifedipine, a modified-release preparation should be used and the same brand prescribed for the duration of treatment to ensure (...) ductus arteriosus and premature delivery [ ]. UKTIS states that there is no strong evidence that exposure to ACE inhibitors in the first trimester is associated with congenital malformations in the infant, but exposure to AIIRAs may be associated with congenital malformations, and AIIRAs should therefore be avoided at all stages of pregnancy [ ]. Choice of alternative antihypertensive treatment when an ACE inhibitor or AIIRA is stopped The recommendation that first-line treatment is usually labetalol

2019 NICE Clinical Knowledge Summaries

151. Opioid dependence

, in particular, seems to promote thrombosis. Venous and arterial thrombosis can result from poor injecting technique, especially in people injecting into the groin. Poor nutrition and dental disease — people who have a history of substance use problems are more likely to have poorer oral and dental health, and may suffer from poor nutrition. Social problems, including: Crime — it is estimated that half of all recorded crime is drug related. Imprisonment. Effect on partner and children including child (...) of family income. Emotional availability to children. The effects on family routines (for example, getting children to school on time). Other people supporting the children (for example, family) and their fitness to provide that support. Ability to access professional support. Storage of illicit drugs, prescribed medication and drug-using paraphernalia. If risk of significant harm to a young person is found, involve other professionals in line with local child protection requirements and child

2019 NICE Clinical Knowledge Summaries

152. Pelvic inflammatory disease

, acute bowel infection, or diverticular disease. See the CKS topics on and for more information. Complications of an ovarian cyst, such as rupture, torsion, or haemorrhage — symptoms are often of sudden onset. Urinary tract infection — often associated with dysuria and/or urinary frequency. See the CKS topic on for more information. Mittelschmerz pain. Functional pain (that is of unknown physical origin) — there may be other longstanding symptoms. Basis for recommendation Basis for recommendation

2019 NICE Clinical Knowledge Summaries

153. Pyelonephritis - acute

. People with megaloblastic anaemia or other blood dyscrasias. Premature infants or children aged under 4 months. Women who are pregnant. Prescribe trimethoprim with caution in people: With impaired renal function. With hyperkalaemia, or taking medication that is known to cause hyperkalaemia. With acute porphyria. Predisposed to folate deficiency — because of the potential anti-folate effect of trimethoprim, there is a risk of further exacerbating folate deficiency in people who are folate deficient (...) in pregnancy. Emphysematous pyelonephritis. Acute pyelonephritis should be diagnosed by taking a detailed medical history and conducting a physical examination. Acute pyelonephritis should be suspected in people with signs or symptoms of a urinary tract infection (for example, dysuria, frequency, urgency) accompanied by any new signs or symptoms of pyelonephritis (including fever, nausea, vomiting, or flank pain). A midstream or catheter specimen of urine should be sent for culture and sensitivity. A urine

2019 NICE Clinical Knowledge Summaries

154. Vaginal discharge

, dysuria, pelvic pain, or intermenstrual or post-coital bleeding. The most common causes of abnormal vaginal discharge are bacterial vaginosis (BV) and vaginal candidiasis. Other causes include sexually transmitted infections (STIs) and non-infective causes, such as retained foreign body, inflammation due to allergy or irritation, tumours, and cervical ectopy or polyps. The nature and/or volume of normal physiological discharge may also be altered by pregnancy, sexual stimulation, contraceptive use (...) , consistency, volume, and/or odour, and may be associated with symptoms such as itch, soreness, dysuria, pelvic pain, or intermenstrual or post-coital bleeding. It is most commonly caused by infection; however, there can be non-infective causes. See the section on for more information. [ ; ; ; ; ; ] Causes of abnormal vaginal discharge What are the causes of abnormal vaginal discharge? Abnormal vaginal discharge is most commonly caused by infection. This includes: Vaginal infections, such as: Bacterial

2019 NICE Clinical Knowledge Summaries

155. Urinary tract infection (lower) - women

assessment is required to exclude other causes before treating for UTI. Pregnancy Pregnancy should be excluded in all women of child-bearing age as untreated UTI in pregnancy is associated with premature labour and low-birthweight [ ]. Symptoms that may indicate another cause of dysuria Urinary symptoms can be due to urethral inflammation (for example due to sexually transmitted infections, inflammation post sexual intercourse or contact with irritants) or symptoms of menopause, atrophic vaginitis (...) infecting organisms. Co-morbidities such as immunosuppression. Complications of lower UTI include pyelonephritis, impaired renal function, urosepsis and in pregnancy pre-term delivery and low-birthweight. Clinical features of lower UTI include dysuria, frequency, urgency, change in urine appearance, nocturia and suprapubic discomfort. Typical features may be absent (in particular in those with underlying cognitive impairment) — UTI may present with delirium and reduced functional ability. Urinary

2019 NICE Clinical Knowledge Summaries

156. Gonorrhoea

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. For more information, see the CKS topic on . Basis for recommendation (...) arthralgia, tenosynovitis, or septic arthritis. In men, if left untreated, complications include epididymitis, infertility and prostatitis. In women, complications include pelvic inflammatory disease (PID). Gonorrhoea in pregnancy is associated with spontaneous abortion and other complications. A diagnosis of gonorrhoea may be suspected on the basis of history, symptoms, and examination. In men, symptoms (such as urethral discharge and dysuria) usually develop 2–5 days after exposure. Examination

2019 NICE Clinical Knowledge Summaries

157. Scrotal pain and swelling

. If there are no features of strangulation or obstruction: For an infant or young boy, refer urgently to a paediatric surgeon (preferably to be seen within 2 weeks). For men or older boys: Refer urgently for surgical repair if the hernia is irreducible, or only partially reducible. Refer all others routinely for surgical repair, unless they have minimally symptomatic inguinal hernias and significant comorbidity, and do not want to have surgery. Basis for recommendation Basis for recommendation These recommendations (...) on the management of varicocele, see the CKS topic on . Scenario: Hydrocele Scenario: Hydrocele Management - congenital How should I manage a boy with a congenital hydrocele? For an infant or toddler with a hydrocele since birth: Reassure the parents that the hydrocele is likely to resolve without treatment by 2 years of age. Progression to hernia is rare and does not result in incarceration. Refer to a paediatric surgeon if any of the following apply: There is an underlying pathology. Concomitant inguinal

2019 NICE Clinical Knowledge Summaries

158. Chlamydia - uncomplicated genital

, purulent vaginal discharge, mucopurulent cervical discharge, deep dyspareunia, dysuria, pelvic pain and tenderness, inflamed or friable cervix. In men: dysuria, urethral discharge, urethral discomfort. Samples are taken by the following methods: In women: endocervical or vulvovaginal swab, or first-void urine sample. In men: first-void urine sample or urethral swab. Treatment should be initiated promptly in all people who test positive for chlamydia, or have symptoms or signs strongly suggestive (...) to reflect the new Faculty of Sexual and Reproductive Healthcare guidance, Drug interactions with hormonal contraception (2011). Issued in June 2011. September 2010 — minor update. The Health Protection Agency (HPA) figures for new diagnoses of chlamydia in 2008/9 have been added. Issued in September 2010. August 2009 — minor update. Advice from the National Institute for Health and Care Excellence (NICE) guideline When to suspect child maltreatment (2009) has been added to this topic. Issued in August

2019 NICE Clinical Knowledge Summaries

159. Neutropenic sepsis

with haematological malignancy was 37.8% [ ]. Expert opinion in a review article notes that people with haematological malignancies such as leukaemia have higher rates of mortality from febrile neutropenia than people with solid tumours [ ]. In a US retrospective analysis of paediatric cancer patients on an intensive care unit (n = 359), the overall mortality from sepsis was 17%. This rate increased to 30% in children who had undergone haematopoietic stem cell transplants. Mortality varied by causative pathogen (...) the right topic? Have I got the right topic? From age 1 month onwards. This CKS topic is largely based on the National Institute for Health and Care Excellence (NICE) clinical guideline Neutropenic sepsis: prevention and management of neutropenic sepsis in cancer patients [ ]. This CKS topic covers when to suspect and refer cases of suspected neutropenic sepsis in children over one month of age and adults in primary care. This CKS topic does not cover the recognition and referral of pregnant

2019 NICE Clinical Knowledge Summaries

160. The Role of Early Goal-Directed Therapy in Severe Sepsis and Septic Shock

The Role of Early Goal-Directed Therapy in Severe Sepsis and Septic Shock Emergency Medicine > Journal Club > Archive > July 2015 Toggle navigation July 2015 The Role of Early Goal-Directed Therapy in Severe Sepsis and Septic Shock Vignette You are working a shift in TCC one busy afternoon when a patient is brought in by EMS for flank pain and a fever. You enter the room the find a 60­‐year female with a history of hypertension who is in no distress. She complains of dysuria, right flank pain (...) recognition and management were vital, and it was likely this increased awareness that has resulted in the drastic reduction in mortality observed. Intranet Locations Contact Us Follow Us: F: (314) 362-0478 EM Statistics Adult ED Visits: 95,600 Pediatric ED Visits: 55,000 Trauma Center: Level 1 Residency Type: 1-4 Fellowship Programs: 5 FT Faculty: 46 Residents: 53 | | | | © 2019 by Washington University in St. Louis One Brookings Drive, St. Louis, MO 63130

2015 Washington University Emergency Medicine Journal Club

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