Digoxin-specific antibody fragment F(ab) ovine
... current expectations for a standalone marketing authorisation application but this is a result of the emergency nature and the prevalence of the condition. The sponsor does not intend to conduct further clinical studies of DigiFab. ...
... current expectations for a standalone marketing authorisation application but this is a result of the emergency nature and the prevalence of the condition. The sponsor does not intend to conduct further clinical studies of DigiFab. ...
AusPAR: Sevelamer hydrochloride
... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
Posanol (Posaconazole)
... from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Clinical Trial Safety Experience with POSANOL® Solution for Injection Solution for Injection Study 1 Solution for Injection Study 1 was a non-comparative multi-center study performed to evaluate t ...
... from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Clinical Trial Safety Experience with POSANOL® Solution for Injection Solution for Injection Study 1 Solution for Injection Study 1 was a non-comparative multi-center study performed to evaluate t ...
Anaphylaxis - World Allergy Organization
... • It prevents and relieves fall in blood pressure and shock. ...
... • It prevents and relieves fall in blood pressure and shock. ...
Early phase PET research in the UK
... PET research in the UK. Hurdles include the volume of paperwork involved, the time required to arrange a first in man microdosing trial, and uncertainty between the definition of a PET clinical trial and a mechanistic study. There is a need to work with the MHRA to reduce regulatory hurdles. 9. Many ...
... PET research in the UK. Hurdles include the volume of paperwork involved, the time required to arrange a first in man microdosing trial, and uncertainty between the definition of a PET clinical trial and a mechanistic study. There is a need to work with the MHRA to reduce regulatory hurdles. 9. Many ...
DUAC Gel - GSK Source
... week induced squamous cell skin tumors in transgenic TgAC mice in a study using 20 weeks of topical treatment. The clinical significance of this is unknown. In a 2-year dermal carcinogenicity study in mice, treatment with DUAC Gel at doses up to 8,000 mg per kg per day (16 times the highest recommen ...
... week induced squamous cell skin tumors in transgenic TgAC mice in a study using 20 weeks of topical treatment. The clinical significance of this is unknown. In a 2-year dermal carcinogenicity study in mice, treatment with DUAC Gel at doses up to 8,000 mg per kg per day (16 times the highest recommen ...
OMNARIS Full Prescribing Information
... Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. OMNARIS Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction i ...
... Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. OMNARIS Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction i ...
aerius kids
... After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors as the drug is effectively excluded from entry into the central nervous system. Wheal and Flare: Desloratadine 5mg was significantly better than placebo, as measured by a reduction in histamine-induced whea ...
... After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors as the drug is effectively excluded from entry into the central nervous system. Wheal and Flare: Desloratadine 5mg was significantly better than placebo, as measured by a reduction in histamine-induced whea ...
united states district court
... indication for Neurontin to include “patients over 12 years of age with epilepsy” and added an indication for “adjunctive therapy in the treatment of partial seizures in pediatric patients age 312 years.” In May 2002, the FDA approved an additional indication for Neurontin, “for the management of po ...
... indication for Neurontin to include “patients over 12 years of age with epilepsy” and added an indication for “adjunctive therapy in the treatment of partial seizures in pediatric patients age 312 years.” In May 2002, the FDA approved an additional indication for Neurontin, “for the management of po ...
Always refer to full prescribing information.
... 45 mg/kg/day in rats and 20 mg/kg/day in rabbits. In the absence of maternal toxicity, indicators of embryofetal toxicity (post-implantation loss and reduction in litter size) were noted at 45 mg/kg/day (38X MRHD based on AUC comparisons) in the oral fertility and embryofetal developmental study co ...
... 45 mg/kg/day in rats and 20 mg/kg/day in rabbits. In the absence of maternal toxicity, indicators of embryofetal toxicity (post-implantation loss and reduction in litter size) were noted at 45 mg/kg/day (38X MRHD based on AUC comparisons) in the oral fertility and embryofetal developmental study co ...
St. John`s Wort - American Botanical Council
... fewer short term adverse side effects. A recent trial comparing SJW with the conventional antidepressant imipramine is the largest comparison trial to date and the first to compare the two agents at the normal daily dose of imipramine (150 mg). (Previous trials used 75 mg imipramine to reduce advers ...
... fewer short term adverse side effects. A recent trial comparing SJW with the conventional antidepressant imipramine is the largest comparison trial to date and the first to compare the two agents at the normal daily dose of imipramine (150 mg). (Previous trials used 75 mg imipramine to reduce advers ...
OnCore® Clinical Research Management Data Entry
... 8. Disease Sites section of the form, click the Select button to choose all the disease sites that are eligible for the protocol from the popup window by checking the appropriate checkboxes and clicking the Add button. 9. Institution section of the form, click the Select button to choose West Virgin ...
... 8. Disease Sites section of the form, click the Select button to choose all the disease sites that are eligible for the protocol from the popup window by checking the appropriate checkboxes and clicking the Add button. 9. Institution section of the form, click the Select button to choose West Virgin ...
Lumacaftor–ivacaftor for treating cystic fibrosis homozygous
... over with cystic fibrosis who are homozygous for the F508del mutation. People were randomised in a 1:1:1 ratio to: lumacaftor 600 mg once daily plus ivacaftor 250 mg twice daily (TRAFFIC, n=183; TRANSPORT, n=185) a fixed-dose combination of lumacaftor 400 mg–ivacaftor 250 mg twice daily (TRAFFIC, n= ...
... over with cystic fibrosis who are homozygous for the F508del mutation. People were randomised in a 1:1:1 ratio to: lumacaftor 600 mg once daily plus ivacaftor 250 mg twice daily (TRAFFIC, n=183; TRANSPORT, n=185) a fixed-dose combination of lumacaftor 400 mg–ivacaftor 250 mg twice daily (TRAFFIC, n= ...
Appropriate use criteria for amyloid PET: A
... The second question deals with diagnostic accuracy (clinical validity) based on an autopsy truth standard. Considerable progress has been achieved to establish clinical validity using histopathology-to-image comparisons. As with other elements of validation, each tracer and its associated interpreta ...
... The second question deals with diagnostic accuracy (clinical validity) based on an autopsy truth standard. Considerable progress has been achieved to establish clinical validity using histopathology-to-image comparisons. As with other elements of validation, each tracer and its associated interpreta ...
HOW TO PRUNE GUIDELINES FOR DECISION SUPPORT SYSTEMS Maarten DE SMET
... project showed up in the list of thesis topics. As a dedicated Linux user, I was excited to step into this web of freely shared information technology in the spirit of the open source philosophy. The open source idea originated in the automobile industry at the start of the 20th century when Henry F ...
... project showed up in the list of thesis topics. As a dedicated Linux user, I was excited to step into this web of freely shared information technology in the spirit of the open source philosophy. The open source idea originated in the automobile industry at the start of the 20th century when Henry F ...
A Family Medicine program for Guyana
... presentations; early detection of breast cancer, colorectal, cancer, cervical cancer and melanoma4,5. These findings are consistent after adjusting for socio-demographic and socioeconomic factors5,7. In line with the desire to ‘close the gap’8, the effect of primary care is most pronounced in areas ...
... presentations; early detection of breast cancer, colorectal, cancer, cervical cancer and melanoma4,5. These findings are consistent after adjusting for socio-demographic and socioeconomic factors5,7. In line with the desire to ‘close the gap’8, the effect of primary care is most pronounced in areas ...
How should I prescribe methadone for detoxification
... group and none in the PB group, while only one patient dropped out in the PB group on day 8. Throughout the 8-day study, patients in both groups received similar amount of adjunct medication: 0.64 +/- 0.07 mg (NB group) of clonidine vs 0.73 +/- 0.15 mg (PB group; NS). Only 25% of patients required u ...
... group and none in the PB group, while only one patient dropped out in the PB group on day 8. Throughout the 8-day study, patients in both groups received similar amount of adjunct medication: 0.64 +/- 0.07 mg (NB group) of clonidine vs 0.73 +/- 0.15 mg (PB group; NS). Only 25% of patients required u ...
PrCOPAXONE - Teva Canada Innovation
... Pregnant Women: There are no adequate and well-controlled studies in pregnant women. No evidence of reproductive toxicity was observed in preclinical studies (see TOXICOLOGY: Reproduction and Teratology). Because animal reproduction studies are not always predictive of human response, this drug shou ...
... Pregnant Women: There are no adequate and well-controlled studies in pregnant women. No evidence of reproductive toxicity was observed in preclinical studies (see TOXICOLOGY: Reproduction and Teratology). Because animal reproduction studies are not always predictive of human response, this drug shou ...
Ziprasidon Pfizer capsule hard ENG SmPC
... An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other ant ...
... An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other ant ...
Prescribing Information
... combination with another HCV direct-acting antiviral, including OLYSIO. A fatal cardiac arrest was reported in a patient receiving a sofosbuvir-containing regimen (ledipasvir/sofosbuvir). Bradycardia has generally occurred within hours to days, but cases have been observed up to 2 weeks after initia ...
... combination with another HCV direct-acting antiviral, including OLYSIO. A fatal cardiac arrest was reported in a patient receiving a sofosbuvir-containing regimen (ledipasvir/sofosbuvir). Bradycardia has generally occurred within hours to days, but cases have been observed up to 2 weeks after initia ...
Centralized Non-Formulary Processing
... Centralization of these reviews has resulted in better adherence to the national criteria and VISN PBM policies and removed local provider influences and pressure, thus increasing evidence-based practice. The PBM Clinical Pharmacy Specialist positions require advanced training or certification as we ...
... Centralization of these reviews has resulted in better adherence to the national criteria and VISN PBM policies and removed local provider influences and pressure, thus increasing evidence-based practice. The PBM Clinical Pharmacy Specialist positions require advanced training or certification as we ...
Prescribing Information
... antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and anti ...
... antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and anti ...
Triumeq - ViiV Healthcare
... Following a hypersensitivity reaction to abacavir, NEVER restart TRIUMEQ or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death. When therapy with TRIUMEQ has been discontinued for reasons other than symptom ...
... Following a hypersensitivity reaction to abacavir, NEVER restart TRIUMEQ or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death. When therapy with TRIUMEQ has been discontinued for reasons other than symptom ...
Study Protocol Phase II clinical trial testing the safety and efficacy of
... refine and standardize MDMA-assisted psychotherapy for PTSD patients. If results of both of these pilot studies, plus another small pilot study to be conducted in Israel, are promising, the data gathered will be used to inform the design of two large (N= at least 280) multi-site Phase III studies of ...
... refine and standardize MDMA-assisted psychotherapy for PTSD patients. If results of both of these pilot studies, plus another small pilot study to be conducted in Israel, are promising, the data gathered will be used to inform the design of two large (N= at least 280) multi-site Phase III studies of ...
Username: Password: Help Join Now (Advanced) American
... experienced URI, while 3 of 13 in the magnesium group and 4 of 13 in the placebo group developed URI. A total of six in both the magnesium and placebo groups reported symptoms of other infections, while none on echinacea did. The authors concluded that preventive treatment of athletes with the E. pu ...
... experienced URI, while 3 of 13 in the magnesium group and 4 of 13 in the placebo group developed URI. A total of six in both the magnesium and placebo groups reported symptoms of other infections, while none on echinacea did. The authors concluded that preventive treatment of athletes with the E. pu ...