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1 Vol.2 o.10 (2004/05/27) MRA.1 [ Desyrel ] trazodone hydrochloride FDA.2 [ Zelnorm ] tegaserod hydrogen maleate ealth Canada.3 ealth Canada.5 [ Viread ] tenofovir disoproxil fumarate ealth Canada.5 [ rthoclone KT3 ] muromonab-cd3 ealth Canada.7 CK Z MEDSAFE.8 MRA Recent reclassifications 2004/05/10 Medicines Act1968 Directive2001/83/EC 3 Prescription nly Medicines PM Pharmacy P General Sale List GSL PM P GSL PM P GSL yoscine butylbromide IBS yoscine 1
2 Adenosine 1 750µg Diclofenac diethylammonium 50g meprazole Clotrimazole 500mg 2% Cetirizine hydrochloride 6 Pre-cooked rice powder GSL Sodium picosulphate 2.5mg Terbinafine hydrochloride C C PM P P GSL FDA FDA MedWatch Web 2004/05/ /05 Changes to Labeling for Desyrel Trazodone ydrochloride Tablets Bristol-Myers Squibb [ Desyrel ] trazodone hydrochloride [ Desyrel ] Bristol-Myers Squibb FDA in vitro trazodone CYP3A P450 3A4 mcpp m-chlorophenylpiperizine trazodone [ Desyrel ] In vitro trazodon CYP3A4 trazodon CYP3A4 ketoconazole ritonavir indinavir 10 ritonavir 200mg trazodone 50mg Trazodone Cmax 34% AUC %Ritonavir trazodone Carbamazepine CYP3A4 Carbamazepine 1 400mg trazodone 1 100mg 300mg 2
3 carbamazepine trazodone mcpp 76% 60% In vitro trazodone CPY3A4 CPY3A4 ritonavir trazodone Cmax AUC Ritonavir trazodone Ketoconazole indinavir CPY3A4 itraconazole nefazodone trazodone Trazodone CPY3A4 trazodone Carbamazepine trazodone trazodone trazodone Cl Cl Trazodone ydrochloride Serotonin2 antagonist/reuptake inhibitor SARI ealth Canada 1. ealth Canada Endorsed Important Safety Information on [ Zelnorm ] tegaserod hydrogen maleate Web 2004/05/ /04/28 ovartis [ Zelnorm ] [ Zelnorm ] serotonin 5-T 4 / [ Zelnorm ]
4 [ Zelnorm ] [ Zelnorm ] [ Zelnorm ] [ Zelnorm ] [ Zelnorm ] [ Zelnorm ] 0.04% [ Zelnorm ] [ Zelnorm ] 11,000 [ Zelnorm ] [ Zelnorm ] [ Zelnorm ] [ Zelnorm ] / [ Zelnorm ] ovartis Pharmaceuticals Canada ealth Canada Product Monograph ovartis Pharmaceuticals Canada ealth Canada Public Advisory ealth Canada Endorsed Important Safety Information on [ Zelnorm ] tegaserod hydrogen maleate 4
5 C 2 C 3 C 2 Tegaserod Maleate 5-T 4 agonist 2. otice to ospitals 2004/05/07 ealth Canada Endorsed Important Safety Information on Absorbable emostatic Agents FDA ealth Products and Foods Branch ealth Canada [ Gelfoam ] Pharmacia & Upjohn [ Surgicel fibrillar absorbable hemostat ] Johnson & Johnson [ Surgifoam absorbable gelatin powder/sponge ] Ferrosan ealth Canada 3. Approval of [ Viread ] tenofovir disoproxil fumarate with Conditions Web 2004/05/ /03/08 ealth Canada trti 1 [ Viread ] tenofovir disoproxil fumarate DF otice of Compliance with conditions C/c [ Viread ] 5
6 Gilead Sciences [ Viread ] [ Viread ] mg DI [ Viread ] 2 18 IV-1 [ Viread ] [ Viread ] [ Viread ] < 60 ml/[ Viread ] [ Viread ] didanosine [ Viread ]didanosine Cmax AUC 48 64% didanosine didanosine [ Viread ] didanosine didanosine didanosine [ Viread ] tenofovir disoproxil fumarate /lamivudine/didanosine tenofovir DF/lamivudine/ abacavir RTI 3 IV IV 3 didanosine lamivudine abacavir lamivudine tenofovir DF [ Viread ] IV-1 RA CD ,000 copies/ml 1 PhaseIII PhaseII IV [ Viread ] 10,000 copies/ml [ Viread ] [ Viread ] [ Viread ] IV trti [ Viread ] IV 0.61 log 10 copies/ml; n=368 [ Viread ] [ Viread ] [ Viread ] 6
7 [ Viread ] mg IV-1 RA 1/100 IV-1 RA 10 Vol.1 o /10/ C 3 C 3 P C 3 C 3 C 3 2 C C 2 Tenofovir Disoproxil Fumarate RTI trti 4. otice to ospitals 2004/05/13 ealth Canada Endorsed Important Safety Information on [ rthoclone KT3 ] muromonab -CD3 [ rthoclone KT3 ] muromonab-cd3 [ rthoclone KT3 ] 17 [ rthoclone KT3 ] [ rthoclone KT3 ] [ rthoclone KT3 ]
8 6 24 [ rthoclone KT3 ] 2 [ rthoclone KT3 ] [ rthoclone KT3 ] [ rthoclone KT3 ] VZV RSV RS EBV CMV SV / EBV EBV LPD EBV LPD [ rthoclone KT3 ] CD3 Muromonab-CD3 IgG2a 1,406 Z MEDSAFE Prescriber Update Articles Myopathy with Statins : Check CK Levels and Interactions Web 2004/05 CK diltiazem 8
9 10 CK 1 20mg 80mg 8 2 CARM Centre for Adverse Reactions Monitoring 6 simvastatin atorvastatin fluvastatin pravastatin 8 Simvastatin diltiazem simvastatin 1 pravastatin bezafibrate 3 2 simvastatin 60mg 80mg CK CK 10 CK 3 10 CK CK CK Simvastatin 1 20mg 0.03% 40mg 0.08% 80mg 0.4% Simvastatin atorvastatin CYP3A4 ; fluvastatin pravastatin CYP3A4 erythromycin itraconazole amiodarone verapamil Diltiazem CYP3A4 1 80mg simvastatin diltiazem 1% diltiazem simvastatin 1 40mg 60mg 2 2 cyclosporin amiodarone verapamil CYP3A4 simvastatin 9
10 atorvastatin Simvastatin atorvastatin Diltiazem simvastatin atorvastatin pravastatin fluvastatin CK C 3 C 3 Simvastatin MG-CoA C 3 F C 2-2 Ca Atorvastatin Calcium ydrate MG-CoA F C 2 a C 3 Fluvastatin Sodium MG-CoA a 2 C C 3 Pravastatin Sodium MG-CoA 10
11 C 3 S C 3 Cl Cl C 3 C 2 C 3 Dilitiazem Ca Bezafibrate EU EMEA 11
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Vol.2 o.8 (2004/04/22) 2004 [ Clozaril ] clozapine DA.1 2004 [ Abilify ] aripiprazole DA.3 ealth Canada.4 Canadian Adverse Reaction ewsletter Vol.14 o.2 April 2004 ealth Canada Sterol sterolin.5 2003.6.7.8
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Vol.1 o.27 (2003. 10. 10) [ Reductil ] sibutramine MRA.1 [ Celance ] pergolide MRA.2 SAIDs MRA.3 MRA.3 [ Prandin ] repaglinide FDA.4 FD&C Blue o.1 FDA.5 [BDDrFVIII] [ ReFacto ] moroctocog- ealth Canada.6
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Vol.3 No.3 2005/02/10 Co-proxamol paracetamol/dextropropoxyphene MHRA.1 2005 1 28 FDA.3 FDA/CDER 2004 11 FDA.3 MCI[ Reminyl ] galantamine Health Canada.5 [ Lariam ] mefloquine Health Canada.5 [ Humira
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Vol.2 No.12 (2004/06/24) I [ Crestor ] rosuvastatin 40mg MHRA.2 domperidone FDA FDA.2 [ Crestor ] rosuvastatin FDA FDA.3 2004 6 9 FDA.4 Health Canada SSRI Health Canada.5 SSRI Health Canada.6 Australian
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CDC MMWR Recommendations and Reports September 30, 2005 / Vol 54 / No. RR-9 Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure
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Vol.3 No.7 2005/04/14 2005 4 7 MHRA FDA Health Canada EMEA [ Bextra ] valdecoxib 2005 [ Avonex ] interferon beta-1a FDA.2 2005 [ Xigris ] drotrecogin alfa FDA.3 2005 [ Trecator ] ethionamide USP FDA.4
HIV1 IAS-USA 1 HIV 1 Amino Acid, Wild-Type Primary Mutation Amino Acid Substitution M I 54 Secondary Mutation Codon Mutation Selected In Vitro MUTATIONS IN THE PROTEASE GENE SELECTED BY PROTEASE INHIBITORS
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Vol.1 o.38 (2003. 12.26) IGIV FDA.1 2003 12 17 FDA.4 Ciprofloxacin.4 floxacin.5 rlistat.7 - Health Canada.9 - Health Canada.10 Health Canada.10 MHRA FDA 1. Immune Globulin Intravenous (Human) (IGIV); Required
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Vol.1 o.20 (2003. 8. 22) RT Million Women Study MRA.1 pyrazinamide rifampin FDA.4 FDA/CDER 2003 4 FDA.4 Salmeterol FDA.9 ADEC TGA.10 MRA 2003.8.8 ormone replacement therapy RTand breast cancer results
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医薬品安全性情報 Vol.1 o.19 (2003. 8. 15) 国立医薬品食品衛生研究所安全情報部 目次各国規制機関情報 FDA/CDER による安全性に関する表示改訂の概要 (2003 年 3 月 ) 米 FDA p.1 更新: 潜伏結核感染の rifampin,pyrazinamide 併用療法に関する有害事象データおよび米国胸部学会 /CDC の勧告 米 CDC p.3 ホルモン補充療法の専門家諮問グループ代表によるアドバイス
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