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Emergency Pediatric Dosing 12-14 kilogram

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161. Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A

curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method. Incremental Recovery (INCREC) [ Time Frame: Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose ] Incremental recovery is the increase in circulating FVIII activity for every IU of Xyntha administered per kilogram of body weight. Other Outcome Measures: Number (...) -emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern [ Time Frame: Baseline up to Day 4 ] The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, RBC morphology, platelet count, white blood cell

2015 Clinical Trials

162. Injectafer (VIT-45, ferric carboxymaltose injection; FCM)

. This request for a waiver is to meet the requirements of Pediatric Research Equity Act (PREA).” It should be noted that pediatric studies of Venofer for iron deficiency anemia in patients age 1.0 g/dL from baseline to the end of study period, the result for the Injectafer arm was superior to that for the Venofer arm in this study. For Study 1VIT09031: Reference ID: 3162510Cross Discipline Team Leader Review NDA 203565 Page 9 of 14 9 For the primary efficacy analysis of Cohort 1 in Study 1VIT09031 (...) or the pooled comparator group for the two pivotal studies (6.0%, 4.1% and 3.5%, respectively). Among patients receiving Injectafer in the two pivotal studies the most common treatment-emergent adverse events leading to study drug discontinuation were flushing and hypertension (0.5% and 0.6% of patients, respectively). See Dr. Lu’s Clinical Review for a detailed description and summary of the adverse events seen with Injectafer for the various safety analysis populations of patients exposed and doses used

2013 FDA - Drug Approval Package

163. Safety and Efficacy Study of Sebelipase Alfa in Patients With Lysosomal Acid Lipase Deficiency

included infants >8 months, children, and adults. At least 4 participants in the study were to be between the age of 2 and 4 years. Eligible participants received sebelipase alfa at a dose of 1 milligram/kilogram (mg/kg) every other week (qow). Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 31 participants Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Multi-Center (...) , Open-Label Study of Sebelipase Alfa in Patients With Lysosomal Acid Lipase Deficiency Actual Study Start Date : June 24, 2014 Actual Primary Completion Date : December 28, 2017 Actual Study Completion Date : December 28, 2017 Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Sebelipase Alfa Pediatric and adult participants initiated IV treatment with sebelipase alfa at a dose

2014 Clinical Trials

164. Study to Evaluate the Efficacy and Safety of REGN2222, for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants

Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1. Other Name: REGN2222 Experimental: Part B: Placebo Matched to Suptavumab Drug: Placebo Matched to Suptavumab Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57. Experimental: Part B: Suptavumab 30 mg/kg- 1 Dose Drug: Suptavumab 30 mg/kg- 1 Dose Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single (...) Respiratory Tract Infection [LRTI]) Up to Day 150 [ Time Frame: From first study drug administration up to Day 150 ] A medically attended RSV infection defined as an infant with positive RSV test by Reverse-transcriptase polymerase chain reaction (RT-PCR) with any of following events: Hospitalized (on basis of assessment of admitting physician) for RSV infection or outpatient visit (emergency room [ER], urgent care [UC], or pediatric clinic visits [for either a sick or well visit]) with RSV lower

2014 Clinical Trials

165. Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency

Biological: BT524 (fibrinogen concentrate from human plasma) Phase 3 Detailed Description: The present study is designed as a prospective, open-label, multicentre, phase I/III study investigating the 14 day single-dose pharmacokinetic properties, efficacy and safety of BT524 following intravenous administration in the treatment or prophylaxis of bleeding in patients with congenital afibrinogenemia or severe congenital hypofibrinogenemia. Study Design Go to Layout table for study information Study Type (...) Date : October 2018 Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: BT524 Single intravenous infusion of a fixed dose of 70 mg BT524 per kilogram body weight (BW) Biological: BT524 (fibrinogen concentrate from human plasma) single intravenous infusion Outcome Measures Go to Primary Outcome Measures : Terminal Elimination Half-life (t1/2) for fibrinogen antigen, [ Time Frame

2014 Clinical Trials

166. A Long-Term, Open-Label Study of LUM001 With a Double-Blind, Placebo Controlled, Randomized Drug Withdrawal Period to Evaluate Safety and Efficacy in Children With Alagille Syndrome

. Condition or disease Intervention/treatment Phase Alagille Syndrome Drug: LUM001 Drug: Placebo Phase 2 Detailed Description: The study is divided into 6 parts: a 6-week open-label, dose escalation period, a 12-week open-label stable dosing period, a 4-week randomized, double-blind, placebo-controlled drug withdrawal period, a 26-week long-term stable dosing period, and an a 52-week optional follow-up treatment period, and a long-term optional follow-up treatment period for eligible participants who (...) will be administered orally once a day (QD) up to 400 microgram per kilogram per day (mcg/kg/day) up to Week 52, followed by an increase in dose orally twice a day (BID) during long-term follow-up based on efficacy (serum bile acid [sBA] level and ItchRO[Obs] score) and safety assessment. Drug: LUM001 LUM001 will be administered orally Once Daily (OD). To be administered Twice Daily (BID) for patients who are eligible. Placebo Comparator: Placebo Placebo will be administered orally once a day during randomized

2014 Clinical Trials

167. Wilms Tumor and Other Childhood Kidney Tumors

to have a congenital anomaly.[ , ] In patients with congenital anomalies and Wilms tumor, nephrogenic rests have been reported in 60% of cases.[ ] Of 295 consecutive patients with Wilms tumor seen at the Institute Curie in Paris, 52 (17.6%) had anomalies or syndromes, 43 of which were considered major, and 14 of which were genetically proven tumor predisposition syndromes.[ ] Children with Wilms tumor may have associated hemihyperplasia and urinary tract anomalies, including cryptorchidism (...) is 67-fold.[ ] About half of individuals with sporadic aniridia and PAX6 and WT1 deletions develop Wilms tumor.[ ] Constitutional 11p15 abnormalities. Constitutional 11p15 abnormalities have been identified in 13 of 437 individuals (3%) with sporadic Wilms tumor without features of growth disorders, including 12% of bilateral cases. All were de novo abnormalities, except for one novel microdeletion in a child whose mother was not affected. This suggests that constitutional 11p15 analysis should

2012 PDQ - NCI's Comprehensive Cancer Database

168. Gastrointestinal Complications

to the abdomen, pelvis, or rectum. One report also documented radiation-induced diarrhea as a result of radiation for lung and head and neck cancers in individuals who were receiving radiation with or without chemotherapy.[ ] The large and small bowel are very sensitive to ionizing radiation. Although the probability of tumor control increases with the radiation dose, so does the damage to normal tissues. Acute side effects to the intestines occur at approximately 10 Gy. Because curative doses for many (...) constipation is common with the use of opioids, a bowel regimen will be initiated at the time opioids are prescribed and continued for as long as the patient takes opioids. Opioids produce varying degrees of constipation, suggesting a dose-related phenomenon. One study suggests that clinicians should not base laxative prescribing on the opioid dose, but rather titrate the laxative according to bowel function. Lower doses of opioids or weaker opioids, such as codeine, are just as likely to cause

2012 PDQ - NCI's Comprehensive Cancer Database

169. Hematopoietic Stem Cell Transplantation (Diagnosis)

. In addition, HSCT is used to allow patients with cancer to receive higher doses of chemotherapy than bone marrow can usually tolerate; bone marrow function is then salvaged by replacing the marrow with previously harvested stem cells. Examples of emerging indications for HSCT include replacement of marrow progenitors for the purpose of making normal red cells (eg, in hemoglobinopathies), making corrective enzymes (eg, in storage disorders), and mediating tissue repair (eg, in epidermolysis bullosa). HSCT (...) Vermylen 50 7.5 9-23 Sibling bone marrow 11 Bu/Cy ± TLI or ATG 2 42 (85) 20 10 5 Bernaudin 34 8 2-14 Sibling bone marrow 1 Bu/Cy ± TLI or ATG 3 31 9 2 1 Locatelli 11 5 1-20 Sibling cord blood 2 Bu/Cy ± ATG/ALG, Bu/Flu/TT 0 10 1 1 1 Panepinto 67 10 2-27 Bone marrow, peripheral blood stem cell, cord blood 5 Bu/Cy (63), other (4) 3 55 10 22 9 Adamkiewicz 3 6 3-12 4/6 Unrelated donor/umbilical cord blood 4 Bu/Cy/ATG 0 2 3 1 1 Abbreviations: ALG, antilymphocyte globulin; ATG, antithymocyte globulin; Bu

2014 eMedicine Pediatrics

170. Mercury (Diagnosis)

. Rec 32. WHO. 2003 Jun 11-12. 282-284. Environmental Protection Agency (EPA). Spills, Disposal and Site Cleanup. US Environmental Protection Agency. Available at . Accessed: March 30, 2009. Jao-Tan C, Pope E. Cutaneous poisoning syndromes in children: a review. Curr Opin Pediatr . 2006 Aug. 18(4):410-6. . Tezer H, Kaya A, Kalkan G, Erkocoglu M, Ozturk K, Buyuktasli M. Mercury poisoning: a diagnostic challenge. Pediatr Emerg Care . 2012 Nov. 28(11):1236-7. . Takaoka S, Kawakami Y, Fujino T, Oh-ishi (...) distress syndrome (ARDS) has been reported following elemental mercury inhalation. Vaccine-associated exposure Thimerosal is a mercury-containing preservative used in some vaccines and other products since the 1930s. No harmful effects have been reported from thimerosal at doses used in vaccines, except for minor reactions, such as redness and swelling at the injection site. However, in July 1999, the Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed

2014 eMedicine.com

171. Therapeutic Injections for Pain Management (Treatment)

of the allowed radiation dose that an individual may receive without the risk of significant side effects. The annual whole body MPD limit for physicians is 50 mSv. The annual MPD for the lens of the eye is 150 mSv, and for the thyroid, gonads and extremities it is 500 mSv. The fluoroscopy's x-ray tube should be kept as far away from the patient as possible. Federal regulations limit the maximum output for C-arm fluoroscopy to 10 R/min at 12 in (30 cm) from the image intensifier. Beam collimation reduces (...) characteristics should be considered when choosing an LA. The latency of onset of anesthetic action is an important clinical property; however, concentration, total dose, distance between the injection site and target, and relative penetrance of the compound also should be considered. Penetrance depends on target-tissue characteristics, including the thickness of superimposed, fibrous, and other intervening tissues. Tissue penetrance of specific LAs determines latency of onset and intensity of induced

2014 eMedicine.com

172. Hypothyroidism (Treatment)

of the following: Give 4 µg of LT4 per kilogram of lean body weight (approximately 200-250 µg) as an IV bolus in a single or divided dose, depending on the patient’s risk of cardiac disease 24 hours later, give 100 µg IV Subsequently, give 50 µg/day IV, along with stress doses of IV glucocorticoids Adjust the dosage on the basis of clinical and laboratory findings If adrenal insufficiency is suspected (eg, in a patient with hypothyroidism secondary to panhypopituitarism), that diagnosis should be investigated (...) and is generally reserved for patients who are not improving clinically on LT4. LT3 can be given initially as a 10 µg IV bolus, which is repeated every 8-12 hours until the patient can take maintenance oral doses of T4. Advanced age, high-dose T4 therapy, and cardiac complications have the highest associations with mortality in myxedema coma (see ). [ ] Previous Next: Complications of Treatment Thyroid hormone replacement can precipitate adrenal crises in patients with untreated adrenal insufficiency

2014 eMedicine.com

173. Therapeutic Injections for Pain Management (Overview)

of the allowed radiation dose that an individual may receive without the risk of significant side effects. The annual whole body MPD limit for physicians is 50 mSv. The annual MPD for the lens of the eye is 150 mSv, and for the thyroid, gonads and extremities it is 500 mSv. The fluoroscopy's x-ray tube should be kept as far away from the patient as possible. Federal regulations limit the maximum output for C-arm fluoroscopy to 10 R/min at 12 in (30 cm) from the image intensifier. Beam collimation reduces (...) characteristics should be considered when choosing an LA. The latency of onset of anesthetic action is an important clinical property; however, concentration, total dose, distance between the injection site and target, and relative penetrance of the compound also should be considered. Penetrance depends on target-tissue characteristics, including the thickness of superimposed, fibrous, and other intervening tissues. Tissue penetrance of specific LAs determines latency of onset and intensity of induced

2014 eMedicine.com

174. Hematopoietic Stem Cell Transplantation (Overview)

. In addition, HSCT is used to allow patients with cancer to receive higher doses of chemotherapy than bone marrow can usually tolerate; bone marrow function is then salvaged by replacing the marrow with previously harvested stem cells. Examples of emerging indications for HSCT include replacement of marrow progenitors for the purpose of making normal red cells (eg, in hemoglobinopathies), making corrective enzymes (eg, in storage disorders), and mediating tissue repair (eg, in epidermolysis bullosa). HSCT (...) Vermylen 50 7.5 9-23 Sibling bone marrow 11 Bu/Cy ± TLI or ATG 2 42 (85) 20 10 5 Bernaudin 34 8 2-14 Sibling bone marrow 1 Bu/Cy ± TLI or ATG 3 31 9 2 1 Locatelli 11 5 1-20 Sibling cord blood 2 Bu/Cy ± ATG/ALG, Bu/Flu/TT 0 10 1 1 1 Panepinto 67 10 2-27 Bone marrow, peripheral blood stem cell, cord blood 5 Bu/Cy (63), other (4) 3 55 10 22 9 Adamkiewicz 3 6 3-12 4/6 Unrelated donor/umbilical cord blood 4 Bu/Cy/ATG 0 2 3 1 1 Abbreviations: ALG, antilymphocyte globulin; ATG, antithymocyte globulin; Bu

2014 eMedicine.com

175. Local Anesthesia and Regional Nerve Block Anesthesia (Overview)

of lidocaine per kilogram of body weight can be administered, whereas as much as 7 mg/kg can be used if the lidocaine solution has 1:100,000 epinephrine added as a vasoconstrictor. For children, lower maximal doses are recommended; only 1.5-2.5 mg/kg of plain lidocaine and 3-4 mg/kg of lidocaine with epinephrine should be used. Systemic toxicity resulting from excessive blood levels of anesthetics is clinically manifested as adverse reactions in the CNS and cardiovascular system. The CNS is affected (...) . A case report of probable drug interactions. Dermatol Surg . 1997 Dec. 23(12):1169-74. . Dinehart SM. Topical, local and regional anesthesia. Wheeland RG, ed. Cutaneous Surgery . Philadelphia: WB Saunders; 1994. 103. Mossetti V, Vicchio N, Ivani G. Local anesthetis and adjuvants in pediatric regional anesthesia. Curr Drug Targets . 2012 Jun. 13(7):952-60. . Auletta M, Grekin R. Local Anesthesia for Dermatologic Surgery . New York: Churchill Livingstone; 1991. Hogan ME, Vandervaart S, Perampaladas K

2014 eMedicine.com

176. Mercury (Overview)

. Rec 32. WHO. 2003 Jun 11-12. 282-284. Environmental Protection Agency (EPA). Spills, Disposal and Site Cleanup. US Environmental Protection Agency. Available at . Accessed: March 30, 2009. Jao-Tan C, Pope E. Cutaneous poisoning syndromes in children: a review. Curr Opin Pediatr . 2006 Aug. 18(4):410-6. . Tezer H, Kaya A, Kalkan G, Erkocoglu M, Ozturk K, Buyuktasli M. Mercury poisoning: a diagnostic challenge. Pediatr Emerg Care . 2012 Nov. 28(11):1236-7. . Takaoka S, Kawakami Y, Fujino T, Oh-ishi (...) distress syndrome (ARDS) has been reported following elemental mercury inhalation. Vaccine-associated exposure Thimerosal is a mercury-containing preservative used in some vaccines and other products since the 1930s. No harmful effects have been reported from thimerosal at doses used in vaccines, except for minor reactions, such as redness and swelling at the injection site. However, in July 1999, the Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed

2014 eMedicine.com

177. Hematopoietic Stem Cell Transplantation (Treatment)

. In addition, HSCT is used to allow patients with cancer to receive higher doses of chemotherapy than bone marrow can usually tolerate; bone marrow function is then salvaged by replacing the marrow with previously harvested stem cells. Examples of emerging indications for HSCT include replacement of marrow progenitors for the purpose of making normal red cells (eg, in hemoglobinopathies), making corrective enzymes (eg, in storage disorders), and mediating tissue repair (eg, in epidermolysis bullosa). HSCT (...) Vermylen 50 7.5 9-23 Sibling bone marrow 11 Bu/Cy ± TLI or ATG 2 42 (85) 20 10 5 Bernaudin 34 8 2-14 Sibling bone marrow 1 Bu/Cy ± TLI or ATG 3 31 9 2 1 Locatelli 11 5 1-20 Sibling cord blood 2 Bu/Cy ± ATG/ALG, Bu/Flu/TT 0 10 1 1 1 Panepinto 67 10 2-27 Bone marrow, peripheral blood stem cell, cord blood 5 Bu/Cy (63), other (4) 3 55 10 22 9 Adamkiewicz 3 6 3-12 4/6 Unrelated donor/umbilical cord blood 4 Bu/Cy/ATG 0 2 3 1 1 Abbreviations: ALG, antilymphocyte globulin; ATG, antithymocyte globulin; Bu

2014 eMedicine.com

178. Hypothyroidism (Follow-up)

of the following: Give 4 µg of LT4 per kilogram of lean body weight (approximately 200-250 µg) as an IV bolus in a single or divided dose, depending on the patient’s risk of cardiac disease 24 hours later, give 100 µg IV Subsequently, give 50 µg/day IV, along with stress doses of IV glucocorticoids Adjust the dosage on the basis of clinical and laboratory findings If adrenal insufficiency is suspected (eg, in a patient with hypothyroidism secondary to panhypopituitarism), that diagnosis should be investigated (...) and is generally reserved for patients who are not improving clinically on LT4. LT3 can be given initially as a 10 µg IV bolus, which is repeated every 8-12 hours until the patient can take maintenance oral doses of T4. Advanced age, high-dose T4 therapy, and cardiac complications have the highest associations with mortality in myxedema coma (see ). [ ] Previous Next: Complications of Treatment Thyroid hormone replacement can precipitate adrenal crises in patients with untreated adrenal insufficiency

2014 eMedicine.com

179. Therapeutic Injections for Pain Management (Follow-up)

of the allowed radiation dose that an individual may receive without the risk of significant side effects. The annual whole body MPD limit for physicians is 50 mSv. The annual MPD for the lens of the eye is 150 mSv, and for the thyroid, gonads and extremities it is 500 mSv. The fluoroscopy's x-ray tube should be kept as far away from the patient as possible. Federal regulations limit the maximum output for C-arm fluoroscopy to 10 R/min at 12 in (30 cm) from the image intensifier. Beam collimation reduces (...) characteristics should be considered when choosing an LA. The latency of onset of anesthetic action is an important clinical property; however, concentration, total dose, distance between the injection site and target, and relative penetrance of the compound also should be considered. Penetrance depends on target-tissue characteristics, including the thickness of superimposed, fibrous, and other intervening tissues. Tissue penetrance of specific LAs determines latency of onset and intensity of induced

2014 eMedicine.com

180. Hematopoietic Stem Cell Transplantation (Follow-up)

. In addition, HSCT is used to allow patients with cancer to receive higher doses of chemotherapy than bone marrow can usually tolerate; bone marrow function is then salvaged by replacing the marrow with previously harvested stem cells. Examples of emerging indications for HSCT include replacement of marrow progenitors for the purpose of making normal red cells (eg, in hemoglobinopathies), making corrective enzymes (eg, in storage disorders), and mediating tissue repair (eg, in epidermolysis bullosa). HSCT (...) Vermylen 50 7.5 9-23 Sibling bone marrow 11 Bu/Cy ± TLI or ATG 2 42 (85) 20 10 5 Bernaudin 34 8 2-14 Sibling bone marrow 1 Bu/Cy ± TLI or ATG 3 31 9 2 1 Locatelli 11 5 1-20 Sibling cord blood 2 Bu/Cy ± ATG/ALG, Bu/Flu/TT 0 10 1 1 1 Panepinto 67 10 2-27 Bone marrow, peripheral blood stem cell, cord blood 5 Bu/Cy (63), other (4) 3 55 10 22 9 Adamkiewicz 3 6 3-12 4/6 Unrelated donor/umbilical cord blood 4 Bu/Cy/ATG 0 2 3 1 1 Abbreviations: ALG, antilymphocyte globulin; ATG, antithymocyte globulin; Bu

2014 eMedicine.com

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