AusPAR Attachment 2: Extract from the Clinical Evaluation Report
... from the Clinical Evaluation Report (CER) prepared by the TGA. This extract does not include sections from the CER regarding product documentation or post market activities. ...
... from the Clinical Evaluation Report (CER) prepared by the TGA. This extract does not include sections from the CER regarding product documentation or post market activities. ...
LSD (Lysergic acid diethylamide), death? and distraction
... • Later revelation by the CIA indicate that he was dosed with LSD without his consent, and may have been bludgeoned and thrown out of his hotel room by CIA agents – no longer considered a clear case of LSD-related suicide” Erowid 2013 ...
... • Later revelation by the CIA indicate that he was dosed with LSD without his consent, and may have been bludgeoned and thrown out of his hotel room by CIA agents – no longer considered a clear case of LSD-related suicide” Erowid 2013 ...
Which neuroreceptors mediate the subjective effects of MDMA in
... In preclinical studies, 3,4-methylenedioxymethamphetamine (MDMA, `Ecstasy') has been shown to release serotonin (5-HT), dopamine and norepinephrine. However, the role of these neurotransmitters and their corresponding receptor sites in mediating the subjective effects of MDMA has not yet been studie ...
... In preclinical studies, 3,4-methylenedioxymethamphetamine (MDMA, `Ecstasy') has been shown to release serotonin (5-HT), dopamine and norepinephrine. However, the role of these neurotransmitters and their corresponding receptor sites in mediating the subjective effects of MDMA has not yet been studie ...
AusPAR: Trastuzumab emtansine - Therapeutic Goods Administration
... The company has proposed a shelf life of 3 years when stored at 2-8°C based on real time storage of a single Phase III batch and stressed storage. The evaluator recommends a shelf life of 24 months at 2-8°C be applied equally to the 100 mg and 160 mg Drug Product presentations based on real time sto ...
... The company has proposed a shelf life of 3 years when stored at 2-8°C based on real time storage of a single Phase III batch and stressed storage. The evaluator recommends a shelf life of 24 months at 2-8°C be applied equally to the 100 mg and 160 mg Drug Product presentations based on real time sto ...
PrDALACIN* C FLAVOURED GRANULES
... palmitate hydrochloride). CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of a ...
... palmitate hydrochloride). CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of a ...
Exelon WS-119-121-G PI highlighted EN
... specific, assessment tools which were assessed at periodic intervals during 6 month treatment periods. These include the ADAS-Cog (a performance based measure of cognition), the CIBIC-Plus (a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS ...
... specific, assessment tools which were assessed at periodic intervals during 6 month treatment periods. These include the ADAS-Cog (a performance based measure of cognition), the CIBIC-Plus (a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS ...
Valerian - E
... Valerian is also used for conditions connected to anxiety and psychological stress including nervous asthma, hysterical states, excitability, fear of illness (hypochondria), headaches, migraine, and stomach upset. Some people use valerian for depression, mild tremors, epilepsy, attention deficit-hyp ...
... Valerian is also used for conditions connected to anxiety and psychological stress including nervous asthma, hysterical states, excitability, fear of illness (hypochondria), headaches, migraine, and stomach upset. Some people use valerian for depression, mild tremors, epilepsy, attention deficit-hyp ...
ACETYLCYSTEINE Solution, USP
... The physical and chemical compatibility of acetylcysteine with certain other drugs that might be concomitantly administered by nebulization, direct instillation, or topical application, has been studied. Acetylcysteine should not be mixed with certain antibiotics. For example, the antibiotics tetrac ...
... The physical and chemical compatibility of acetylcysteine with certain other drugs that might be concomitantly administered by nebulization, direct instillation, or topical application, has been studied. Acetylcysteine should not be mixed with certain antibiotics. For example, the antibiotics tetrac ...
Clinical and pharmacological evaluation of buprenorphine and
... effects and was considered liable to abuse by these subjects. The buprenorphine and naloxone combination was very aversive and not substantially different from naloxone alone. Following the combination dose, opiate agonist effects did eventually emerge but they were always delayed and attenuated whe ...
... effects and was considered liable to abuse by these subjects. The buprenorphine and naloxone combination was very aversive and not substantially different from naloxone alone. Following the combination dose, opiate agonist effects did eventually emerge but they were always delayed and attenuated whe ...
Discriminative Stimulus Properties of MDMA
... unique and complex subjective effects which distinguish it from other recreationally used drugs. An understanding of the neurochemical mechanisms that underlie these effects is important in order to assess the potential for MDMA abuse and to inform researchers exploring of the drug’s therapeutic pot ...
... unique and complex subjective effects which distinguish it from other recreationally used drugs. An understanding of the neurochemical mechanisms that underlie these effects is important in order to assess the potential for MDMA abuse and to inform researchers exploring of the drug’s therapeutic pot ...
Acquisition of Nicotine Discrimination and Discriminative Stimulus
... tend to smoke more cigarettes while drinking coffee, and they ...
... tend to smoke more cigarettes while drinking coffee, and they ...
DIPYRIDAMOLE TABLETS USP 25 MG, 50 MG AND 75 MG
... In these trials, the coumarin anticoagulant was begun between 24 hours and 4 days postoperatively, and the dipyridamole tablets were begun between 24 hours and 10 days postoperatively. The length of follow-up in these trials varied from 1 to 2 years. Dipyridamole tablets do not influence prothrombi ...
... In these trials, the coumarin anticoagulant was begun between 24 hours and 4 days postoperatively, and the dipyridamole tablets were begun between 24 hours and 10 days postoperatively. The length of follow-up in these trials varied from 1 to 2 years. Dipyridamole tablets do not influence prothrombi ...
labetalol hydrochloride injection usp
... since it may not have its usual effects in the treatment of anaphylaxis. On the one hand, larger doses of epinephrine may be needed to overcome the bronchospasm, while on the other, these doses can be associated with excessive alpha adrenergic stimulation with consequent hypertension, reflex bradyca ...
... since it may not have its usual effects in the treatment of anaphylaxis. On the one hand, larger doses of epinephrine may be needed to overcome the bronchospasm, while on the other, these doses can be associated with excessive alpha adrenergic stimulation with consequent hypertension, reflex bradyca ...
Zolpidem Physical Dependence Assessed Across Increasing Doses
... showed full generalization to zolpidem, whereas diazepamand pentobarbital-trained rats did (Ator and Griffiths, 1992a). However, Rowlett and Woolverton (1997) found that pentobarbital-trained rats did not generalize to zolpidem. Rats trained to discriminate a low and a high dose of midazolam from th ...
... showed full generalization to zolpidem, whereas diazepamand pentobarbital-trained rats did (Ator and Griffiths, 1992a). However, Rowlett and Woolverton (1997) found that pentobarbital-trained rats did not generalize to zolpidem. Rats trained to discriminate a low and a high dose of midazolam from th ...
Australian public assessment for Febuxostat (FBX)
... conditions. For Cmax, AUC from time 0 to T (AUCt) and AUC from 0 to infinity (AUC∞), the 90% confidence intervals for the relative bioavailability of FBX from Regimen B (one 120 mg tablet administered under non-fasting conditions) to Regimen A (one 120 mg tablet administer under fasting conditions) ...
... conditions. For Cmax, AUC from time 0 to T (AUCt) and AUC from 0 to infinity (AUC∞), the 90% confidence intervals for the relative bioavailability of FBX from Regimen B (one 120 mg tablet administered under non-fasting conditions) to Regimen A (one 120 mg tablet administer under fasting conditions) ...
A Review of the Toxicity and Environmental Behaviour of Bromine in
... Bromine is an oxidising acidic gas with a noxious odour. The principal sources are associated with bromine production and use in the chemical industry. As a result, releases are often of short duration due to batch operations. A number of measurement methods have been published for bromine but while ...
... Bromine is an oxidising acidic gas with a noxious odour. The principal sources are associated with bromine production and use in the chemical industry. As a result, releases are often of short duration due to batch operations. A number of measurement methods have been published for bromine but while ...
Characterization of a novel model of chronic migraine
... therapy sumatriptan in the chronic NTG model. Consistent with previous studies [3], we found that sumatriptan (600 lg/kg, i.p.) reversed the acute hyperalgesia evoked by NTG injection. Systemic Sumatriptan continued to effectively ameliorate acute NTG-evoked hyperalgesia with each injection over 9 d ...
... therapy sumatriptan in the chronic NTG model. Consistent with previous studies [3], we found that sumatriptan (600 lg/kg, i.p.) reversed the acute hyperalgesia evoked by NTG injection. Systemic Sumatriptan continued to effectively ameliorate acute NTG-evoked hyperalgesia with each injection over 9 d ...
Australian public assessment Report for Abiraterone Acetate
... evidence of abiraterone binding to the androgen receptor (AR) and inhibiting AR activation induced by eplerenone, suggesting abiraterone may inhibit prostate cancer growth by AR binding, in addition to enzyme inhibition. Atrophy of hormone-sensitive reproductive organs was consistently observed in r ...
... evidence of abiraterone binding to the androgen receptor (AR) and inhibiting AR activation induced by eplerenone, suggesting abiraterone may inhibit prostate cancer growth by AR binding, in addition to enzyme inhibition. Atrophy of hormone-sensitive reproductive organs was consistently observed in r ...
SUMMARY OF PRODUCT CHARACTERISTIC
... Data regarding efficacy and safety of fluconazole in children and adolescents less than 16 years of age are still limited. Therefore the benefits of the treatment with fluconazole should be carefully evaluated against the risks. Patients concurrently receiving fluconazole at doses below 400 mg/day a ...
... Data regarding efficacy and safety of fluconazole in children and adolescents less than 16 years of age are still limited. Therefore the benefits of the treatment with fluconazole should be carefully evaluated against the risks. Patients concurrently receiving fluconazole at doses below 400 mg/day a ...
Journal home page: http://www.iajpr.com/index.php/en/ INDO
... Tremendous approved pharmacological activity of Aegle marmelos Antidiabetic activity Diabetes mellitus is metabolic disorder which independent risk factor for coronary artery disease, hypertension, myocardial infaraction & hyperlipidemia. Diabetes & its related complication are closely related with ...
... Tremendous approved pharmacological activity of Aegle marmelos Antidiabetic activity Diabetes mellitus is metabolic disorder which independent risk factor for coronary artery disease, hypertension, myocardial infaraction & hyperlipidemia. Diabetes & its related complication are closely related with ...
Paracetamol - IARC Monographs on the Evaluation of Carcinogenic
... Figure 1. The major urinary metabolites (the glucuronide, sulfate and 3-mercapto derivatives) are observed in most species, although there is much species variation regarding the percentages of these conjugates excreted in the urine (Davis et al., 1976). Each of the other metabolites shown in Figure ...
... Figure 1. The major urinary metabolites (the glucuronide, sulfate and 3-mercapto derivatives) are observed in most species, although there is much species variation regarding the percentages of these conjugates excreted in the urine (Davis et al., 1976). Each of the other metabolites shown in Figure ...
vancomycin 500mg and 1000mg powder for concentrate for solution
... Based on the results, a shelf life of 2 years for the unopened products has been set, with storage instructions “Store below 25°C. Keep the vial in the outer carton in order to protect from light”. This is satisfactory. From a microbiological point of view, the medicinal products should be used imme ...
... Based on the results, a shelf life of 2 years for the unopened products has been set, with storage instructions “Store below 25°C. Keep the vial in the outer carton in order to protect from light”. This is satisfactory. From a microbiological point of view, the medicinal products should be used imme ...
Is there Evidence to Support the use of Enteric Coated (EC) Aspirin
... that the use of EC aspirin was associated with less mucosal damage. However, limitations of this research included only using a Medline search, no reported search strategy, no details given of the papers reviewed, and no attempt to aggregate data. The RCT’s reviewed by Walker et al. were small scale ...
... that the use of EC aspirin was associated with less mucosal damage. However, limitations of this research included only using a Medline search, no reported search strategy, no details given of the papers reviewed, and no attempt to aggregate data. The RCT’s reviewed by Walker et al. were small scale ...
PRODUCT MONOGRAPH
... In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia, or melaena) and when gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with PANTOLOC® (pantoprazole sodium) is instituted ...
... In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia, or melaena) and when gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with PANTOLOC® (pantoprazole sodium) is instituted ...
Influence of Yohimbine on Blood Pressure, Autonomic Reflexes, and
... Investigator-observed, or subject-volunteered, effects of yohimbine during dose-ranging and doubleblind phases are listed in table 2. During the doubleblind studies, three of five subjects correctly guessed the yohimbine day in retrospect. Two were unable to differentiate yohimbine from saline, even ...
... Investigator-observed, or subject-volunteered, effects of yohimbine during dose-ranging and doubleblind phases are listed in table 2. During the doubleblind studies, three of five subjects correctly guessed the yohimbine day in retrospect. Two were unable to differentiate yohimbine from saline, even ...
Hormesis
Hormesis (from Greek hórmēsis ""rapid motion, eagerness,"" from ancient Greek hormáein ""to set in motion, impel, urge on"") is the term for generally favorable biological responses to low exposures to toxins and other stressors. A pollutant or toxin showing hormesis thus has the opposite effect in small doses as in large doses. A related concept is Mithridatism, which refers to the willful exposure to toxins in an attempt to develop immunity against them. Hormetics is the term proposed for the study and science of hormesis.In toxicology, hormesis is a dose response phenomenon characterized by a low dose stimulation, high dose inhibition, resulting in either a J-shaped or an inverted U-shaped dose response. Such environmental factors that would seem to produce positive responses have also been termed ""eustress.""The hormesis model of dose response is vigorously debated. The notion that hormesis is important for chemical risks regulations is not widely accepted.The biochemical mechanisms by which hormesis works are not well understood. It is conjectured that low doses of toxins or other stressors might activate the repair mechanisms of the body. The repair process fixes not only the damage caused by the toxin, but also other low-level damage that might have accumulated before without triggering the repair mechanism.