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November 2015 PBAC Meeting Agenda
November 2015 PBAC Meeting Agenda

... circumstances, consumers will be able to comment on items in other sections of the agenda. The submissions for which input is sought will be listed in alphabetical order by drug name. There is no provision for consumer comments to the PBAC on agenda item 8 which relates to pricing matters. Pharmaceu ...
Ampicillin
Ampicillin

... the beta-lactam moiety or to the amino group in the side-chain, or to a toxic reaction. The occurrence of a maculopapular rash during ampicillin use does not necessarily preclude the subsequent use of other penicillins. However, since it may be difficult in practice to distinguish between hypersensi ...
VP Anesthesiology Patel 2002 - University of British Columbia
VP Anesthesiology Patel 2002 - University of British Columbia

... dopamine, and dobutamine, are currently used to achieve these goals. A number of studies favor norepinephrine as an effective vasopressor to maintain an adequate mean arterial pressure during septic shock.2– 4 However, at high doses, norepinephrine has several potential adverse effects, including in ...
ZITHROMAX (azithromycin tablets) and
ZITHROMAX (azithromycin tablets) and

... In asymptomatic HIV-seropositive adult subjects receiving 600-mg ZITHROMAX tablets once daily for 22 days, steady state azithromycin serum levels were achieved by Day 15 of dosing. When azithromycin capsules were administered with food, the rate of absorption (Cmax) of azithromycin was reduced by 52 ...
First-aid treatment of anaphylaxis to food: Focus on epinephrine
First-aid treatment of anaphylaxis to food: Focus on epinephrine

... studies would be difficult to conduct because anaphylaxis episodes usually occur without warning in a nonmedical setting and differ in severity among individuals and from one episode to another in the same individual; consequently, baseline measurements and frequent timed measurements would be hard ...
Evaluation of Diuretic activities of hydro
Evaluation of Diuretic activities of hydro

... Results: The hydro-alcoholic extract increased diuresis significantly at the doses of 400 and 600 mg/kg (p<0.001), while the solvent fractions of the hydro-alcoholic extract the aqueous and n-butanol fractions significantly increased urine volume (p< 0.01) at 400 mg/kg, with maximum urine output at ...
AusPAR: Metformin HCI / Linagliptin
AusPAR: Metformin HCI / Linagliptin

... extending the half-life of glucagon-like peptide 1 (GLP-1). GLP-1 lowers blood glucose by augmenting the glucose-stimulated insulin release and limiting glucagon secretion, and is associated with slowing of gastric emptying. It is approved for combination use with metformin in Australia. Metformin h ...
Low-Dose Methotrexate: A Mainstay in the Treatment of Rheumatoid
Low-Dose Methotrexate: A Mainstay in the Treatment of Rheumatoid

... Methotrexate is generally administered to patients with rheumatoid arthritis as a single weekly dose given either intramuscularly or orally. In the treatment of rheumatoid arthritis, the usual dose of methotrexate is in the range of 15 to 17.5 mg/week, although early studies utilized much lower dose ...
METHOTREXATE 25 MG/ML SOLUTION FOR INJECTION
METHOTREXATE 25 MG/ML SOLUTION FOR INJECTION

... The application and dosage recommendations for the administration of methotrexate (low-dose therapy, mostly as part of polychemotherapy) for different indications varies considerably. Some common dosages and therapy protocols, which have proved to be efficacious in the therapy of the disorder in eac ...
DRUG ENCAPSULATION IN PECTIN HYDROGEL BEADS- A SYSTEMATIC STUDY OF
DRUG ENCAPSULATION IN PECTIN HYDROGEL BEADS- A SYSTEMATIC STUDY OF

... In plant cells, the biological activities of the pectin fragments are well know 18 as well as their size dependency: fragments with a degree of polymerization higher than 8 are able to associate intermolecularly through Ca2+ bridges to form so-called “egg boxes”, a conformation that determines their ...
Cyclomen (danazol)
Cyclomen (danazol)

... appear to be ethisterone and 17-hydroxymethylethisterone. The mean plasma elimination half-life of danazol is in the order of 24 hours. Bioavailability studies indicate that blood levels do not increase proportionally with increases in the administered dose. When the dose of Cyclomen is doubled the ...
Discriminative Stimulus Properties of MDMA
Discriminative Stimulus Properties of MDMA

... in 1977 and the United States Drug Enforcement Administration (DEA) placed the drug on the highest schedule of controlled substances in 1985 citing animal studies that suggested neurotoxicity. In New Zealand, MDMA was initially scheduled under part 2 of Class B in the Misuse of Drugs act in 1975 but ...
Astelin
Astelin

... There have been no reported overdosages with Astelin Nasal Spray. Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse reactions, other than increased somnolence, since one bottle of Astelin Nasal Spray contains 30 mg of azelastine hydrochloride. C ...
metronidazole
metronidazole

... adverse reactions have involved the gastrointestinal tract, particularly nausea, sometimes accompanied by headache, anorexia and occasionally vomiting, diarrhoea, epigastric distress and abdominal cramping; constipation and oral mucositis have also been reported. A metallic, sharp unpleasant taste i ...
Prescribing Information - REMS Program | SUBOXONE
Prescribing Information - REMS Program | SUBOXONE

... Patients dependent on heroin or other short‐acting opioid products   Patients dependent on heroin or short‐acting opioid products may be inducted with either SUBOXONE sublingual  film or with sublingual buprenorphine monotherapy.  The first dose of SUBOXONE sublingual film or  buprenorphine should b ...
Grapefruit juice–drug interactions
Grapefruit juice–drug interactions

... A systematic examination for obvious possible causes, such as incorrect dose or drug assay problems, did not resolve this discrepancy and eventually resulted in a pilot project in a single volunteer to judge the role of the juice. Plasma felodipine concentrations were more than five-fold greater wit ...
Greenway FL, Whitehouse MJ, Guttadauria M
Greenway FL, Whitehouse MJ, Guttadauria M

... subjects provided a medical history and received a physical examination, electrocardiogram, waist circumference, fasting chemistry panel, complete blood count, urinalysis, thyroid stimulating hormone, and were administered the Hospital Anxiety and Depression Scale. Qualifying subjects were then blin ...
Apo-Amoxi
Apo-Amoxi

... than those those recommended recommended bacteriological and clinical clinical appraisals above should not be used. In stubborn infections, therapy therapy may be required required for several several weeks. It necessary to continue continue clinical clinical and/or and/or bacteriological bacteriolo ...
oxycodone controlled release tablets
oxycodone controlled release tablets

... The usual starting dose for opioid-naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 10 mg 12-hourly, or 5 mg 12-hourly for patients with renal or hepatic impairment. The dose should then be carefully titrated, as frequently as once a day if necessary, to achie ...
Mash-Summary-Ibogain..
Mash-Summary-Ibogain..

... tion of the cerebellar purkinje cells in rats. Molinari et at.63 reevaluate,d in reducof ibogaine. In this study, a lower dose (40 mg/kg) of ibogaine, one effective the above ation degener no d displaye on, inistrati self-adm ing morphin e and cocaine degenerative level seen in saline-treated contro ...
P R E S C R I B I N G I N F O R M A T I O N
P R E S C R I B I N G I N F O R M A T I O N

... patients experiencing partial onset seizures, immediaterelease KEPPRA causes the occurrence of central nervous system adverse reactions that can be classified into the following categories: 1) somnolence and fatigue, 2) coordination difficulties, and 3) behavioral abnormalities. In controlled trials ...
CASE  4-16180/-JCIP APPENDIX  F
CASE 4-16180/-JCIP APPENDIX F

... submitted to this IND with respect to the issue of ‘acute renal failure’. The contents of the investigator aieti for this case is included and contains what actions Novartis has taken and will take. ...
Product Monograph - Paladin Labs Inc.
Product Monograph - Paladin Labs Inc.

... Interactions between GlucaGen® (glucagon) and other drugs are not known, when GlucaGen® is used in diabetes. Published literature has shown the following interactions: Insulin: Reacts antagonistically towards glucagon (12). Indomethacin: Glucagon may lose its ability to raise blood glucose or parado ...
Doc - PAGE meetings
Doc - PAGE meetings

... Hoai Thu Thai A-41 Bootstrap methods for estimating uncertainty of parameters in mixed-effects models ....................................................................................................................................................52 Celia Barthelemy A-42 New methods for complex m ...
Warfarin-herb interactions: a review and study based on assessment
Warfarin-herb interactions: a review and study based on assessment

... adults in developed countries and more than 60% Asians use herb as an alternative medicines (Zhou, 2007; Anonymous, 2006). Despite widespread use of herbal remedies, scientific data about their safety and efficacy are lacking in most cases plus reporting of adverse drug events is currently limited. ...
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