Ordin nr. 1301/500/2008 din 11 iulie 2008 Partea a ii-a
Tratamentul pacienţilor cu neoplasm de sân metastatic cu HER2 amplificat
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| Tratamentul pacienţilor cu neoplasm de sân metastatic cu HER2 amplificat:
a) ca monoterapie în cazul pacienţilor trataţi cu cel puţin două regimuri chimioterapice pentru boala lor metastatică. Chimioterapia anterioară trebuie să fi inclus cel puţin o antraciclină şi un taxan, cu excepţia cazurilor în care aceste chimioterapice nu erau indicate. Pacienţii pozitivi la receptorii hormonali trebuie de asemenea să fi prezentat un eşec la tratamentul hormonal, cu excepţia cazurilor în care acest tip de tratament nu a fost indicat. b) în asociere cu Paclitaxel pentru tratamentul pacienţilor care nu au primit chimioterapie pentru boala lor metastatică şi pentru care nu este indicat tratamentul cu antracicline. Herceptin trebuie folosit numai la pacienţii ale căror tumori prezintă HER2 amplificat la nivel 3+, determinat prin imunohistochimie. Trastuzumab nu trebuie utilizat la pacienţi cu o fracţie de ejecţie ventriculară a ventriculului stâng mai mică de 45% şi/sau cu insuficienţă cardiacă simptomatică. Funcţia cardiacă trebuie testată. ________________________________________________________________________________ DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XC03 TRASTUZUMABUM PULB. PT. CONC. PT. 150 mg SOL. PERF. HERCEPTIN 150 mg 150 mg ROCHE REGISTRATION LTD. ________________________________________________________________________________
| 745 |L01XC06| CETUXIMABUM**** | Protocol: L037C | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XC06 CETUXIMABUM SOL. PERF. 2 mg/ml ERBITUX 2 mg/ml 2 mg/ml MERCK KGAA
ERBITUX 5 mg/ml 5 mg/ml MERCK KGAA L01XC06 CETUXIMABUM SOL. PERF. 5 mg/ml ERBITUX 5 mg/ml 5 mg/ml MERCK KGAA ________________________________________________________________________________
| 746 |L01XC07| BEVACIZUMABUM**** | Protocol: L004C | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XC07 BEVACIZUMABUM CONC. PT. SOL. PERF. 25 mg/ml AVASTIN 25 mg/ml 25 mg/ml ROCHE REGISTRATION LTD. ________________________________________________________________________________ ______________________________________________________________________________ | 747 |L01XE01| IMATINIBUM**** | Protocol: L008C | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XE01 IMATINIBUM CAPS. 100 mg GLIVEC 100 mg 100 mg NOVARTIS EUROPHARM LTD.
GLIVEC 100 mg 100 mg NOVARTIS EUROPHARM LTD. L01XE01 IMATINIBUM CAPS. 100 mg GLIVEC 100 mg 100 mg NOVARTIS EUROPHARM LTD. ________________________________________________________________________________
| 748 |L01XE03| ERLOTINIBUM**** | Protocol: L031C | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XE03 ERLOTINIBUM COMPR. FILM. 100 mg TARCEVA 100 mg 100 mg ROCHE REGISTRATION LTD.
TARCEVA 150 mg 150 mg ROCHE REGISTRATION LTD. L01XE03 ERLOTINIBUM COMPR. FILM. 25 mg TARCEVA 25 mg 25 mg ROCHE REGISTRATION LTD. ________________________________________________________________________________
| 749 |L01XE04| SUNITINIBUM**** | Protocol: L042C | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XE04 SUNITINIBUM CAPS. 12,5 mg SUTENT 12,5 mg 12,5 mg PFIZER LIMITED
SUTENT 25 mg 25 mg PFIZER LIMITED L01XE04 SUNITINIBUM CAPS. 50 mg SUTENT 50 mg 50 mg PFIZER LIMITED ________________________________________________________________________________
| 750 |L01XE05| SORAFENIBUM**** | Protocol: L038C | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XE05 SORAFENIBUM COMPR. FILM. 200 mg NEXAVAR 200 mg 200 mg BAYER HEALTHCARE AG ________________________________________________________________________________ ______________________________________________________________________________ | 751 |L01XE06| DASATINIBUM**** | Protocol: L035C | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XE06 DASATINIBUM COMPR. FILM. 20 mg SPRYCEL 20 mg 20 mg BRISTOL-MYERS SQUIBB PHARMA EEIG L01XE06 DASATINIBUM COMPR. FILM. 50 mg SPRYCEL 50 mg 50 mg BRISTOL-MYERS SQUIBB PHARMA EEIG
SPRYCEL 70 mg 70 mg BRISTOL-MYERS SQUIBB PHARMA EEIG
SPRYCEL 20 mg 20 mg BRISTOL-MYERS SQUIBB PHARMA EEIG
SPRYCEL 50 mg 50 mg BRISTOL-MYERS SQUIBB PHARMA EEIG
SPRYCEL 70 mg 70 mg BRISTOL-MYERS SQUIBB PHARMA EEIG ________________________________________________________________________________ ______________________________________________________________________________ | 753 |L01XX02| ASPARAGINAZUM | | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XX02 ASPARAGINAZUM LIOF. PT. SOL. 10000 ui INJ./PERF. ASPARAGINASE 10000 MEDAC 10000 ui MEDAC GESELLSCAFT FUR KUNISCHE SPEZIALPRĂPARATE
INJ./PERF. ASPARAGINASE 5000 MEDAC 5000 ui MEDAC GESELLSCAFT FUR KUNISCHE SPEZIALPRĂPARATE ________________________________________________________________________________
| 754 |L01XX05| HYDROXYCARBAMIDUM | | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XX05 HYDROXYCARBAMIDUM CAPS. 500 mg HYDREA 500 mg BRISTOL MYERS SQUIBB KFT ________________________________________________________________________________ ______________________________________________________________________________ | 755 |L01XX11| ESTRAMUSTINUM | | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XX11 ESTRAMUSTINUM CAPS. 140 mg ESTRACYT 140 mg PFIZER EUROPE MA EEIG ________________________________________________________________________________ ______________________________________________________________________________ | 757 |L01XX17| TOPOTECAMUM | | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XX17 TOPOTECAMUM PULB. CONC. SOL. PERF. 4 mg HYCAMTIN 4 mg 4 mg SMITHKLINE BEECHAM PLC ________________________________________________________________________________ ______________________________________________________________________________ | 758 |L01XX19| IRINOTECANUM | | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XX19 IRINOTECANUM CONC. PT. SOL. PERF. 20 mg/ml CAMPTO 100 mg/5 ml 20 mg/ml PFIZER EUROPE MA EEIG IRINOTESIN 20 mg/ml 20 mg/ml ACTAVIS S.R.L. L01XX19 IRINOTECANUM CONC. PT. SOL. PERF. 20 mg/ml CAMPTO 100 mg/5 ml 20 mg/ml PFIZER EUROPE MA EEIG IRINOTESIN 20 mg/ml 20 mg/ml ACTAVIS S.R.L. ________________________________________________________________________________ ______________________________________________________________________________ | 759 |L01XX32| BORTEZOMIBUM**** | Protocol: L012C | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L01XX32 BORTEZOMIBUM PULB. PT. SOL. INJ. 3.5 mg VELCADE 3,5 mg 3.5 mg JANSSEN-CILAG INTERNATIONAL NV ________________________________________________________________________________
| 760 |L02AB01| MEGESTROLUM | | |_______|_______|____________________________________________|_________________|
DCI/DENUMIRE COMERCIALĂ FORMA FARM. __________________________________________________ CONCENTRAŢIE FIRMA ________________________________________________________________________________ L02AB01 MEGESTROLUM COMPR. 160 mg MEGESIN 160 mg 160 mg ACTAVIS S.R.L.
MEGACE 40 mg/ml BRISTOL MYERS SQUIBB KFT ________________________________________________________________________________
| 761 |L02AE02| LEUPRORELINUM** | | |_______|_______|____________________________________________|_________________|
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