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Stretch experienced staff Use your experienced healthcare workers to supervise newly recruited and or reassigned staff. They can oversee the care for many residents if they are not consumed with providing care to a few. Utilize the core skills listed above and organize resident care in the most efficient manner possible. Use this strategy to pair experienced staff with new staff in dietary, laundry, payroll and housekeeping as well if at all possible. Consistent staff assignments Cohort sick residents, and assign consistent staff to them. Minimize the floating of staff in all departments but especially with staff who are caring for contagious residents. Ideally, the staff assigned to care for sick residents will be: Licensed The most experienced Vaccinated or given antiviral treatment or have recovered from the illness themselves so they are not at a high risk of infection Staff dependants If feasible, organize a safe space at the facility for staff to bring their dependant family members who would otherwise be left unsupervised while staff are at work as a result of school closures, etc. Keep expectations realistic Be realistic about what you can do. Focus on providing basic and essential care to the greatest number of people 54 and watch for staff burnout. Staff burnout Recognize and prepare for caregiver burnout. Caregivers are not immune to the stress and grief of a pandemic. Facilitate access to mental health professionals, clergy and support groups and provide access at the facility if possible. Organize time for caregivers to rest, eat, relax and talk about what they are feeling if they need to. Consider providing literature on the signs and symptoms of burnout and ways to cope with it. It may not be possible to resolve caregiver burnout in a crisis situation, but it is important to recognize it, acknowledge that it exists and take steps to protect residents from it by supporting or replacing staff who have reached their limit of effectiveness. Signs of Caregiver Burnout 55 Being on the verge of tears or crying a lot Feeling helpless or hopeless Overreacting to minor nuisances Constant exhaustion Loss of interest apathy Decreased productivity Social withdrawal Increased use of alcohol or stimulants Change in eating or sleeping habits Inability to relax Scattered thinking Increased feelings of resentment.
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61. Deval B, Vulierme MP, Poilpot S, Menu Y, Levardon M. [Imaging pelvic floor prolapse] J Gynecol Obstet Biol Reprod Paris ; . 32: 22-9, 2003. Kaufman HS, Buller JL, Thompson JR, Pannu HK, DeMeester SL, Genadry RR, Bluemke DA, Jones B, Rychcik JL, Cundiff GW. Dynamic pelvic magnetic resonance imaging and cystocolpoproctography alter surgical management of pelvic floor disorders. Dis Colon Rectum. 44: 1575-83; discussion 1583-4, 2001. 63. Singh K, Reid WM, Berger LA. Assessment and grading of pelvic organ prolapse by use of dynamic magnetic resonance imaging. J Obstet Gynecol. 185: 71-7, 2001. Strohbehn K, Quint LE, Wojno EJ, DeLancey JOL. Magnetic resonance imaging anatomy of the female urethra: A direct histologic comparison. Obstet Gynecol 88: 750-6, 1996. Umek WH, Kearney R, Morgan DM, Ashton-Miller JA, DeLancey JO. The axial location of structural regions in the urethra: a magnetic resonance study in nulliparous women. Obstet Gynecol. 102: 1039-45, 2003. Tan IL, Stoker J, Zwamborn AW, Entius KA, Calame JJ, Lameris JS.Female pelvic floor: endovaginal MR imaging of normal anatomy. Radiology. 206 3 ; : 777-83, 1998. 67. Chou Q, DeLancey JO. A structured system to evaluate urethral support anatomy in magnetic resonance images. J Obstet Gynecol. 185 1 ; : 44-50, 2001. 68. Tunn R, Delancey JO, Howard D, Ashton-Miller JA, Quint LE. Anatomic variations in the levator ani muscle, endopelvic fascia, and urethra in nulliparas evaluated by magnetic resonance imaging. J Obstet Gynecol. 188 1 ; : 116-21, 2003. 69. Singh K, Reid WM, Berger LA. Assessment and grading of pelvic organ prolapse by use of dynamic magnetic resonance imaging. J Obstet Gynecol. 185 1 ; : 71-7, 2001. 70. Torricelli P, Pecchi A, Caruso Lombardi A, Vetruccio E, Vetruccio S, Romagnoli R.Magnetic resonance imaging in evaluating functional disorders of female pelvic floor. Radiol Med 103 56 ; : 488-500, 2002. 71. Handa VL, Pannu HK, Siddique S, Gutman R, VanRooyen J, Cundiff G. Architectural differences in the bony pelvis of women with and without pelvic floor disorders. Obstet Gynecol. 102: 1283-90, 2003. Mant J, Painter R, Vessey M. epidemiology of genital prolapse: observations from the Oxford Family Planning Association Study. Br J Obstet Gynaecol; 104 5 ; : 579-585, 1997. 73. DeLancey JO, Kearney R, Chou Q, Speights S, Binno S. The appearance of levator ani muscle abnormalities in magnetic resonance images after vaginal delivery. Obstet Gynecol 101 1 ; : 4653, 2003. 74. Bump RC, Mattiasson A, B K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. J Obstet Gynecol 175 1 ; : 10-17, 1996. 75. Gufler H, DeGregorio G, Dohnicht S, Allmann KH, Rohr-Reyes A. Dynamic MRI after surgical repair for pelvic organ prolapse. J Comput Assist Tomogr. 26: 734-9, 2002. Umek WH, Morgan DM, Ashton-Miller JA, DeLancey JO. Quantitative analysis of uterosacral ligament origin and insertion points by magnetic resonance imaging. Obstet Gynecol 103 3 ; : 447-51, 2004. B2-IV. IMAGING IN POST-PROSTATECTOMY INCONTINENCE 1. Leach GE, Vip C and Donovan BJ: Post-prostatectomy incontinence: the influence of bladder dysfunction. J Urol, 138: 574, 1987.
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References 1. Bateman E et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma controL study. Am. J. Respir. Crit. Care Med. 2004; 170 836-844 Rabe KF et al. Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe AIRE ; study. Eur Resp J 2000; 16: 802-807 Bellamy D, Harris T. Poor perceptions and expectations of asthma control: results of the International Control of Asthma Symptoms ICAS ; patient survey. Eur Respir J 2004; 24 Suppl 48 ; : 83s plus Poster.
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NDA 20-596 S-025 NDA 20-564 S-024 Page 18 Study ACTG300, pancreatitis was not observed in 236 patients randomized to EPIVIR plus RETROVIR. Pancreatitis was observed in 1 patient in this study who received open-label EPIVIR in combination with RETROVIR and ritonavir following discontinuation of didanosine monotherapy. Paresthesias and peripheral neuropathies were reported in 15 patients 15% ; in Study A2002, 6 patients 9% ; in Study A2005, and 2 patients 1% ; in Study ACTG300. Limited short-term safety information is available from 2 small, uncontrolled studies in South Africa in neonates receiving lamivudine with or without zidovudine for the first week of life following maternal treatment starting at Week 38 or 36 gestation see PRECAUTIONS: Pediatric Use ; . Adverse events reported in these neonates included increased liver function tests, anemia, diarrhea, electrolyte disturbances, hypoglycemia, jaundice and hepatomegaly, rash, respiratory infections, sepsis, and syphilis; 3 neonates died 1 from gastroenteritis with acidosis and convulsions, 1 from traumatic injury, and 1 from unknown causes ; . Two other nonfatal gastroenteritis or diarrhea cases were reported, including 1 with convulsions; 1 infant had transient renal insufficiency associated with dehydration. The absence of control groups further limits assessments of causality, but it should be assumed that perinatally exposed infants may be at risk for adverse events comparable to those reported in pediatric and adult HIV-infected patients treated with lamivudine-containing combination regimens. Long-term effects of in utero and infant lamivudine exposure are not known. Lamivudine in Patients With Chronic Hepatitis B: Clinical trials in chronic hepatitis B used a lower dose of lamivudine 100 mg daily ; than the dose used to treat HIV. The most frequent adverse events with lamivudine versus placebo were ear, nose, and throat infections 25% versus 21% malaise and fatigue 24% versus 28% and headache 21% versus 21% ; , respectively. The most frequent laboratory abnormalities reported with lamivudine were elevated ALT, elevated serum lipase, elevated CPK, and posttreatment elevations of liver function tests. Emergence of HBV viral mutants during lamivudine treatment, associated with reduced drug susceptibility and diminished treatment response, was also reported also see WARNINGS and PRECAUTIONS ; . Please see the complete prescribing information for EPIVIR-HBV Tablets and Oral Solution for more information. Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of lamivudine. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to lamivudine. Body as a Whole: Redistribution accumulation of body fat see PRECAUTIONS: Fat Redistribution ; . Digestive: Stomatitis. Endocrine and Metabolic: Hyperglycemia. General: Weakness. Hemic and Lymphatic: Anemia including pure red cell aplasia and severe anemias progressing on therapy ; , lymphadenopathy, splenomegaly. Hepatic and Pancreatic: Lactic acidosis and hepatic steatosis, pancreatitis, posttreatment exacerbation of hepatitis B see WARNINGS and PRECAUTIONS ; . Hypersensitivity: Anaphylaxis, urticaria. Musculoskeletal: Muscle weakness, CPK elevation, rhabdomyolysis. Nervous: Paresthesia, peripheral neuropathy. Respiratory: Abnormal breath sounds wheezing. Skin: Alopecia, rash, pruritus and leukeran.
EPIVIR Tablets lamivudine tablets ; EPIVIR Oral Solution lamivudine oral solution ; concurrent infection with hepatitis B virus. Information for Patients: EPIVIR is not a cure for HIV infection and patients may continue to experience illnesses associated with HIV infection, including opportunistic infections. Patients should remain under the care of a physician when using EPIVIR. Patients should be advised that the use of EPIVIR has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Patients should be advised that EPIVIR Tablets and Oral Solution contain a higher dose of the same active ingredient lamivudine ; as EPIVIR-HBV Tablets and Oral Solution. If a decision is made to include lamivudine in the HIV treatment regimen of a patient dually infected with HIV and HBV, the formulation and dosage of lamivudine in EPIVIR not EPIVIR-HBV ; should be used. Patients should be advised that the long-term effects of EPIVIR are unknown at this time. EPIVIR Tablets and Oral Solution are for oral ingestion only. Patients should be advised of the importance of taking EPIVIR exactly as it is prescribed. Parents or guardians should be advised to monitor pediatric patients for signs and symptoms of pancreatitis. Drug Interaction: TMP 160 mg SMX 800 mg once daily has been shown to increase lamivudine exposure AUC ; . The effect of higher doses of TMP SMX on lamivudine pharmacokinetics has not been investigated see CLINICAL PHARMACOLOGY ; . Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term carcinogenicity studies with lamivudine in mice and rats showed no evidence of carcinogenic potential at exposures up to 10 times mice ; and 58 times rats ; those observed in humans at the recommended therapeutic dose for HIV infection. Lamivudine was not active in a microbial mutagenicity screen or an in vitro cell transformation assay, but showed weak in vitro mutagenic activity in a cytogenetic assay using cultured human lymphocytes and in the mouse lymphoma assay. However, lamivudine showed no evidence of in vivo genotoxic activity in the rat at oral doses of up to 2000 mg kg producing plasma levels of 35 to times those in humans at the recommended dose for HIV infection. In a study of reproductive performance, lamivudine administered to rats at doses up to 4000 mg kg per day, producing plasma levels 47 to 70 times those in humans, revealed no evidence of impaired fertility and no effect on the survival, growth, and development to weaning of the offspring. Pregnancy: Pregnancy Category C. Reproduction studies have been performed in rats and rabbits at orally administered doses up to 4000 mg kg per day and 1000 mg kg per day respectively, producing plasma levels up to approximately 35 times that for the adult HIV dose. No evidence of teratogenicity due to lamivudine was observed. Evidence of early embryolethality was seen in the rabbit at exposure levels similar to those observed in humans, but there was no indication of this effect in the rat at exposure levels up to 35 times that in humans. Studies in pregnant rats and rabbits showed that lamivudine is transferred to the fetus through the placenta.
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INDICATIONS AND USAGE EPIVIR-HBV is indicated for the treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation. This indication is based on 1-year histologic and serologic responses in adult patients with compensated chronic hepatitis B, and more limited information from a study in pediatric patients ages 2 to 17 years see Description of Clinical Studies below ; . Description of Clinical Studies: Adults: The safety and efficacy of EPIVIR-HBV were evaluated in 4 controlled studies in 967 patients with compensated chronic hepatitis B. All patients were 16 years of age or older and had chronic hepatitis B virus infection serum HBsAg positive for at least 6 months ; accompanied by evidence of HBV replication serum HBeAg positive and positive for serum HBV DNA, as measured by a research solution-hybridization assay ; and persistently elevated ALT levels and or chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis. Three of these studies provided comparisons of EPIVIR-HBV 100 mg once daily versus placebo, and results of these comparisons are summarized below. Study 1 was a randomized, double-blind study of EPIVIR-HBV 100 mg once daily versus placebo for 52 weeks followed by a 16-week no-treatment period in treatment-naive US patients.
The majority of lamivudine-treated patients showed a decrease of HBV DNA to below the assay limit early in the course of therapy. However, reappearance of assay-detectable HBV DNA during lamivudine treatment was observed in approximately one third of patients after this initial response. Pediatrics: The safety and efficacy of EPIVIR-HBV were evaluated in a double-blind clinical trial in 286 patients ranging from 2 to 17 years of age, who were randomized 2: 1 ; to receive 52 weeks of lamivudine 3 mg kg once daily to a maximum of 100 mg once daily ; or placebo. All patients had compensated chronic hepatitis B accompanied by evidence of hepatitis B virus replication positive serum HBeAg and positive for serum HBV DNA by a research branched-chain DNA assay ; and persistently elevated serum ALT levels. The combination of loss of HBeAg and reduction of HBV DNA to below the assay limit of the research assay, evaluated at Week 52, was observed in 23% of lamivudine subjects and 13% of placebo subjects. Normalization of serum ALT was achieved and maintained to Week 52 more frequently in patients treated with EPIVIR-HBV compared with placebo 55% versus 13% ; . As in the adult controlled trials, most lamivudine-treated subjects had decreases in HBV DNA below the assay limit early in treatment, but about one third of subjects with this initial response had reappearance of assay-detectable HBV DNA during treatment. Adolescents ages 13 to 17 years ; showed less evidence of treatment effect than younger children. CONTRAINDICATIONS EPIVIR-HBV Tablets and EPIVIR-HBV Oral Solution are contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the products. WARNINGS Lactic Acidosis Severe Hepatomegaly with Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Most of these reports have described patients receiving nucleoside analogues for treatment of HIV infection, but there have been reports of lactic acidosis in patients receiving lamivudine for hepatitis B. Particular caution should be exercised when administering EPIVIR or EPIVIR-HBV to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with EPIVIR or EPIVIR-HBV should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations ; . Important Differences Between Lamivudine-Containing Products, HIV Testing, and Risk of Emergence of Resistant HIV: EPIVIR-HBV Tablets and Oral Solution contain a lower dose of the same active ingredient lamivudine ; as EPIVIR Tablets and Oral Solution, COMBIVIR lamivudine zidovudine ; Tablets, and TRIZIVIR abacavir, lamivudine, 9 and mysoline.
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EPIVIR-HBV is indicated for the treatment of compensated CHB associated with evidence of viral replication and active liver inflammation in adults and children 2 to 17 years of age. This indication is based on 1-year histologic and serologic responses in adult patients and more limited data from a study in pediatric patients. Safety and efficacy of EPIVIR-HBV have not been established in patients with decompensated liver disease. Patients should be advised that treatment with EPIVIR-HBV has not been shown to reduce the risk of transmission of HBV to others. The relationship between treatment response and long-term outcomes, such as hepatocellular carcinoma or decompensated cirrhosis, is not known. Safety and effectiveness of treatment beyond 1 year have not been established, and the optimal duration of treatment is not known. EPIVIR-HBV is not appropriate for patients dually infected with HBV and human immunodeficiency virus HIV ; . Important safety information continued on back of card and atrovent.
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Fig. 2. KaplanMeier estimates of event rates for time to the first on-study skeletal-related event for all intent-to-treat patients with metastatic prostate cancer randomly assigned to receive zoledronic acid at 4 mg, zoledronic acid at 8 4 mg, or placebo. The number of patients at risk at each time point is shown in the table below the graph. Percentage of patients 95% confidence interval [CI] ; without a skeletal-related event at 90 days: zoledronic acid at 4 mg, 90.9% 95% CI 86.8% to 94.9% zoledronic acid at 8 4 mg, 83.3% 95% CI 78.2% to 88.4% placebo, 83.5% 95% CI 78.4% to 88.7% at 270 days: zoledronic.
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If lamivudine isadministered to such patients, the higher dosage indicated for hiv therapyshould be used as part of an appropriate combination regimen, and theprescribing information for epivir as well as epivir-hbv should beconsulted.
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