natgillin/translations-raw huggingface dataset:
Vihuma 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Vihuma 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 500 International Units simoctocog alfa (200 IU/ml after reconstitution).
1 viala s praškom vsebuje 500 mednarodnih enot simoktokoga alfa (200 i.e./ml po rekonstituciji).
Common side effects may affect up to 1 in 10 people Hypersensitivity, fever.
Pogosti neželeni učinki se lahko pojavijo pri največ 1 od 10 bolnikov
Vihuma 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Vihuma 3000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 3000 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
Vihuma 4000 IU contains approximately 1600 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Zdravilo Vihuma 4000 i.e. vsebuje po rekonstituciji približno 1600 i.e./ml humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
Vihuma 3000 IU contains approximately 1200 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Zdravilo Vihuma 3000 i.e. vsebuje po rekonstituciji približno 1200 i.e./ml humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
NAME OF THE MEDICINAL PRODUCT Vihuma 2500 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 2500 mednarodnih enot prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
Common* Uncommon* Uncommon* Uncommon*
občasni* občasni* občasni*
PC:
Profilaksa:
STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 1000 International Units simoctocog alfa (400 IU/ml after reconstitution).
1 viala s praškom vsebuje 1000 mednarodnih enot simoktokoga alfa (400 i.e./ml po rekonstituciji).
Vihuma 1000 IU contains approximately 400 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Zdravilo Vihuma 1000 i.e. vsebuje po rekonstituciji približno 400 i.e./ml humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
Attach the threaded end of the plunger rod to the solvent syringe plunger.
Pritrdite navojni konec ročaja bata na bat brizge z vehiklom.
NAME OF THE MEDICINAL PRODUCT Vihuma 500 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 500 mednarodnih enot prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
glass vial, closed with coated bromobutyl stopper and sealed with aluminium flip-off cap - Solvent: 2.5 ml water for injections in a pre-filled borosilicate glass syringe - 1 sterile vial adapter for reconstitution with 1 butterfly needle and 2 alcohol swabs
Eno pakiranje vsebuje: - 1 vialo s praškom z 250, 500, 1000, 2000, 2500, 3000 ali 4000 i.e. simoktokoga alfa v viali iz stekla tipa 1, zaprti z obloženim bromobutilnim zamaškom in zaščiteni z aluminijasto snemljivo zaporko - Vehikel: 2,5 ml vode za injekcije v napolnjeni borosilikatni stekleni injekcijski brizgi - 1 sterilen vmesnik za vialo za rekonstitucijo z 1 iglo z držalom v obliki metuljčka in 2 alkoholna zloženca
NAME OF THE MEDICINAL PRODUCT Vihuma 250 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 250 mednarodnih enot prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
Injection site inflammation Injection site pain Malaise
Splošne težave in spremembe na mestu aplikacije zvišana telesna temperatura vnetje na mestu injiciranja bolečina na mestu injiciranja slabo počutje pogosti*
Vihuma 500 IU contains approximately 200 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Zdravilo Vihuma 500 i.e. vsebuje po rekonstituciji približno 200 i.e./ml humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
NAME OF THE MEDICINAL PRODUCT Vihuma 4000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 4000 mednarodnih enot prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT Vihuma 3000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 3000 mednarodnih enot prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT Vihuma 1000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 1000 mednarodnih enot prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/007
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1168/007
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/005
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1168/005
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 2500 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
IME ZDRAVILA IN POT(I) UPORABE Vihuma 2500 mednarodnih enot prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
Inhibitors
aminokislinami.
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1168/002
Ear and labyrinth disorders
Ušesne bolezni, vključno z motnjami labirinta vrtoglavica občasni*
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/006
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1168/006
NAME OF THE MEDICINAL PRODUCT Vihuma 2000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 2000 mednarodnih enot prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 250 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
IME ZDRAVILA IN POT(I) UPORABE Vihuma 250 mednarodnih enot prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/004
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1168/004
Attach the provided infusion set to the syringe.
Pritrdite priloženi infuzijski sistem na brizgo.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 1000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
IME ZDRAVILA IN POT(I) UPORABE Vihuma 1000 mednarodnih enot prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1168/001
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 3000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
IME ZDRAVILA IN POT(I) UPORABE Vihuma 3000 mednarodnih enot prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 4000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
IME ZDRAVILA IN POT(I) UPORABE Vihuma 4000 mednarodnih enot prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/003
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1168/003
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 500 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
IME ZDRAVILA IN POT(I) UPORABE Vihuma 500 mednarodnih enot prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
Mean ± SD
kratka sapa.
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
katere znak je bolečina, ne ustavi oziroma dokler se ne začne celjenje.
Dry mouth
VIALA S PRAŠKOM
For long-term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days.
Za dolgoročno preprečevanje krvavitev pri bolnikih s hudo hemofilijo A znašajo običajni odmerki od
The applicant has applied for a Marketing Authorisation in several member states through the Mutual Recognition Procedure with Czech Republic as reference member state (RMS).
Predlagatelj je predložil vlogo za izdajo dovoljenja za promet v več državah članicah po postopku medsebojnega priznavanja s Češko republiko kot referenčno državo članico.
National Competent Authorities, coordinated by the Reference Member State (RMS), shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Pristojni nacionalni organi, ki jih koordinira referenčna država članica, morajo zagotoviti, da imetniki dovoljenj za promet z zdravilom izpolnijo naslednje pogoje:
Viale G. Richard 7, 20143 Milano Italy
Viale G. Richard 7, 20143 Milano Italija
The bioequivalence between the reference and test products was sufficiently proven and was not questioned in this referral.
Bioekvivalenca med referenčnim in testnim zdravilom je bila v zadostni meri dokazana in v tem postopku napotitve ni bila vprašljiva.
The Article 29 referral procedure was initiated due to concerns raised by Germany on the potential serious risk to public health regarding the benefit/risk ratio of this product.
Postopek napotitve v skladu s členom 29 je bil sprožen zaradi pomislekov Nemčije glede potencialnega tveganja za javno zdravje, in sicer zaradi razmerja med tveganji in koristmi tega zdravila.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
It binds to androgen receptors without activating gene expression and thus inhibits androgen stimulation.
Veže se na androgene receptorje, ne da bi aktiviral gensko ekspresijo, in tako zavira androgeno stimulacijo.
A reduction in risk of objective disease progression was seen across most patient groups but was most evident in those at highest risk of disease progression.
Tveganje za objektivno napredovanje bolezni se je zmanjšalo v večini skupin bolnikov, najočitneje pa pri bolnikih z najvišjim tveganjem za napredovanje bolezni.
For patients with localised disease, receiving bicalutamide alone, there was no significant difference in progression free survival.
Pri bolnikih z lokalizirano boleznijo, ki so dobivali samo bikalutamid, ni bilo bistvenih razlik pri preživetju brez napredovanja.
TEVA Classics S.A. 1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 France
1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 Francija
Pharmacotherapeutic group: anti-androgens, ATC code: L02BB03
Farmakoterapevtska skupina: antiandrogeni, ATC koda: L02BB03.
Therefore, the CHMP has recommended to maintain the Marketing Authorisations for all medicinal products and to grant Marketing Authorisations for all applications referred to in Annex I of the Opinion in accordance with the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet, set out in Annex III of the Opinion.
CHMP je zato priporočil ohranitev dovoljenj za promet za vsa zdravila in podelitev dovoljenj za promet za vse vloge iz Dodatka I Mnenja, skladno s spremembami ustreznih poglavij Povzetka glavnih značilnosti zdravila in Navodila za uporabo, kot so navedene v Dodatku III Mnenja.
Treatment discontinuation may result in antiandrogen withdrawal syndrome in some patients.
Prenehanje zdravljenja lahko pri nekaterih bolnikih povzroči „antiandrogen odtegnitveni sindrom“.
Anti-androgens act against the effects of androgens (male sex hormones).
Antiandrogeni delujejo proti androgenom (moškim spolnim hormonom).
Hazard ratio (95% CI)
Koeficient tveganja (95% IZ)
Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing.
Zato se lahko zdravniki odločijo , da je optimalna medicinska strategija pri bolniku z majhnim tveganjem za napredovanje bolezni, zlasti v adjuvantnih okoliščinah po radikalni prostatektomiji, odložitev hormonskega zdravljenja, dokler se ne pojavijo znaki napredovanja bolezni.
At 7.4 years median follow-up, 27.4 % of all bicalutamide-treated patients and 30.7 % of all placebo-treated patients had experienced objective disease progression.
Po mediano 7,4 leta spremljanja se je objektivno napredovanje bolezni pojavilo pri 27,4% vseh bolnikov, ki so prejemali bikalutamid, in pri 30,7% vseh bolnikov, ki so prejemali placebo.
Inhibition results in the regression of prostatic tumours.
Posledica tega zaviranja je regresija tumorjev prostate.
The CHMP also concluded that a potential association between the use of bicalutamide 150 mg and heart failure could not be ruled out and therefore considered that the need to further study cardiovascular morbidity and mortality remains.
CHMP je nadalje ugotovil, da potencialne povezave med uporabo bikalutamida 150 mg in srčno odpovedjo ni mogoče izključiti, ter zato meni, da so potrebne nadaljnje študije kardiovaskularne obolevnosti in smrtnosti.
Progression-free survival and overall survival data for patients with locally advanced disease are summarised in the following tables:
Podatki o preživetju brez napredovanja in celotnem preživetju bolnikov z lokalno napredovalo boleznijo so povzeti v naslednjih dveh preglednicah:
Bicalutamide is a non-steroidal anti-androgen without any other endocrine activity.
Bikalutamid je nesteroidni antiandrogen brez drugih endokrinih učinkov.
Bicalutamide is used in adult men for the treatment of prostate cancer without metastases, when castration or other types of treatment are not indicated or unacceptable.
Bikalutamid uporabljamo za zdravljenje odraslih moških z rakom prostate brez zasevkov, kadar kastracija ali drugi načini zdravljenja niso primerni ali sprejemljivi.
In these patients there was also a trend toward decreased survival compared with placebo patients (HR=1.16, 95% CI 0.99 to 1.37).
Pri teh bolnikih je bil opazen tudi trend zmanjšanega preživetja v primerjavi z bolniki, ki so dobivali placebo (koeficient tveganja=1,16, 95% IZ 0,99 do 1,37).
- In addition to routine pharmacovigilance activities, identified and potential risks highlighted for increased monitoring and follow-up should include heart failure, hepatic failure, interstitial lung disease, breast cancer, and reports concerning pregnancy in partners of patients taking bicalutamide.
- Poleg rutinskih farmakovigilančnih aktivnosti je treba med ugotovljena in potencialna tveganja, izbrana za podroben nadzor in spremljanje, vključiti odpoved srca, odpoved jeter, intersticijsko pljučno bolezen, rak dojke ter poročila, ki obravnavajo nosečnost pri partnerjih bolnikov, ki jemljejo bikalutamid.
In view of this, the benefit-risk profile for the use of bicalutamide is not considered favourable in this group of patients.
Glede na to, velja razmerje med koristjo in tveganjem pri tej skupini bolnikov za neugodno.
The valid labelling text is the final version achieved during the Coordination group procedure.
Veljavno označevanje je zadnja različica, ki je bila pripravljena v postopku koordinacijske skupine.
No overall survival difference was seen at 7.4 years median follow-up with 22.9% mortality (HR = 0.99; 95% confidence interval 0.91 to 1.09).
Po mediano 7,4 leta spremljanja ni bilo razlik v preživetju; umrljivost je bila 22,9%, (koeficient tveganja[J1]= 0,99; 95% interval zaupanja 0,91 do 1,09).
The CHMP concluded that the benefit/risk balance of bicalutamide 150 mg containing medicinal products in the agreed restricted indication is favourable.
CHMP je zaključil, da je razmerje med koristmi in tveganji za zdravila, ki vsebujejo bikalutamid 150 mg, pri usklajeni omejeni indikaciji ugodno.
are generic preparations containing bicalutamide as the active substance.
je generično zdravilo, ki vsebuje zdravilno učinkovino bikalutamid.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BICALUTAMIDE 150 mg CONTAINING MEDICINAL PRODUCTS
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO BIKALUTAMID 150 mg
However some trends were apparent for patients in exploratory subgroup analyses.
Vendar so eksplorativne analize pokazale nekatere trende.
It may be used in combination with radiotherapy or prostate surgery in early treatment programmes.
V programih zgodnjega zdravljenja se lahko se uporablja v kombinaciji z radioterapijo ali kirurškim posegom na prostati.
acceptable for registration based on a positive benefit/risk ratio of bicalutamide 150mg containing products as recently assessed in the Casodex Article 31 Referral.
primerne za registracijo zaradi pozitivnega razmerja med tveganji in koristmi zdravil, ki vsebujejo bikalutamid 150 mg, kot je bilo nedavno ugotovljeno v postopku napotitve v skladu s členom 31 za zdravilo Casodex.
The effectiveness of bicalutamide 150 mg in the treatment of patients with locally advanced prostatic carcinoma without metastases, for whom primary treatment with hormones was indicated, was evaluated separately using the meta-analysis of two studies comprising 480 patients with prostatic carcinoma without metastases (M0) who had not been treated before.
Učinkovitost 150 mg bikalutamida za zdravljenje lokalno napredovalega karcinoma prostate brez metastaz, za kar je bilo hormonsko zdravljenje primarno indicirano, je bila ovrednotena posebej z uporabo meta analize dveh študij, ki sta zajeli 480 predhodno nezdravljenih bolnikov s karcinomom prostate brez metastaz (M0).
The Committee, considering the Casodex Referral (bicalutamide 150 mg) made under article 31 of Directive 2001/83/EC for medicinal products containing bicalutamide, reached the conclusion that bicalutamide 150mg is effective in the treatment of locally advanced prostate cancer; however the CHMP considered that the therapeutic indication should be restricted to: “Bicalutamide 150mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression”.
Odbor je ob upoštevanju postopka napotitve za zdravilo Casodex (bikalutamid 150 mg), sproženem v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo bikalutamid, sklenil, da je bikalutamid 150 mg učinkovit pri zdravljenju lokalno napredovalega raka prostate, vendar pa je treba terapevtsko indikacijo omejiti na: „Bikalutamid 150 mg je indiciran bodisi samostojno ali kot dodatek k radikalni prostatektomiji ali radioterapiji pri bolnikih z lokalno napredovalim rakom prostate, pri katerih obstaja veliko tveganje za napredovanje bolezni“.
Combined analysis of 2 clinical studies comprising 805 patients with metastatic prostatic carcinoma, who had not been treated before with expected mortality 43%, showed that the treatment with bicalutamide 150 mg is less effective than castration as for the survival time (HR = 1.30 [confidence interval 1.04 - 1.65]).
Kombinirana analiza dveh kliničnih študij, ki sta zajeli 805 predhodno nezdravljenih bolnikov s karcinomom prostate z zasevki, s pričakovano smrtnostjo 43%, je pokazala, da je zdravljenje s 150 mg bikalutamidom glede preživetja manj učinkovito kot kastracija (koeficient tveganja = 1,30 [interval zaupanja 1,04-1,65]).Ocenjena razlika je 42 dni, medtem ko je srednji čas preživetja 2 leti.
Based on these conclusions, the CHMP considered generic Bicalutamide 150mg film-coated tablets (Ingers Industrial Solutions s.r.o.)
Na podlagi teh zaključkov je CHMP sklenil, da so generične Bikalutamid 150 mg filmsko obložene tablete (Ingers Industrial Solutions s.r.o.)
Events (%) in placebo patients
Dogodki (%) pri bolnikih, ki so prejemali placebo
The United Kingdom
Velika Britanija
Bicalutamide is an oral-androgen used in the management of locally advanced prostate cancer, as an immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Bikalutamid je peroralni antiandrogen, ki se uporablja pri zdravljenju lokalno napredovalega raka prostate, in sicer kot takojšnje samostojno zdravljenje ali kot dodatek k zdravljenju z radikalno prostatektomijo ali radioterapijo.
Bicalutamide 150mg film-coated tablets (Ingers Industrial Solutions s.r.o.)
Bikalutamid 150 mg filmsko obložene tablete (Ingers Industrial Solutions s.r.o.)
Bicaluplex 150 mg tablets are indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1).
Zdravilo Bicaluplex 150 mg tablete je indicirano bodisi kot monoterapija ali kot adjuvantna terapija poleg radikalne prostatektomije ali radioterapije pri bolnikih z lokalno napredovalim rakom prostate z visokim tveganjem napredovanja bolezni (glejte poglavje 5.1).
0.81 (0.66 to 1.01)
0,81 (0,66 do 1,01)
Bicalutamida Teva
Bicalutamid-Teva
1.09 (0.85 to 1.39)
1,09 (0,85 do 1,39)
Deaths (%) in placebo patients
Smrti (%) pri bolnikih, ki so prejemali placebo
Bicalutamide 150 mg was studied as a treatment for patients with localized (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, any N, M0; T1-T2, N+, M0) non-metastatic prostate cancer, in a combined analysis of 3 placebo-controlled double-blind studies in 8,113 patients, where the product was given as immediate hormone therapy or as adjuvant to radical prostatectomy or radiotherapy (primarily external beam radiation).
Bikalutamid v odmerku 150 mg je bil proučevan kot terapija za bolnike z lokaliziranim (T1-T2, N0 ali NX, M0) ali lokalno napredovalim (T3-T4, katerikoli N, M0; T1-T2, N+, M0) nemetastatskim rakom prostate v kombinirani analizi treh s placebom kontroliranih, dvojno slepih študij pri 8113 bolnikih.
Bicalutamide is a racemate, the (R)-enantiomer of which has most of the anti-androgen activity.
Bikalutamid je racemat, katerega antiandrogeno delovanje je skoraj izključno omejeno na (R)enantiomer.
The scope of Bicaluplex Article 29 Referral concerns the benefit/risk ration of both indications: treatment of locally advanced prostatic cancer and monotherapy in early treatment or as adjunct to treatment with radiotherapy or radical prostatectomy in patients with prostate cancer.
Predmet postopka napotitve v skladu s členom 29 za zdravilo Bicaluplex se nanaša na razmerje med tveganji in koristmi pri obeh indikacijah: zdravljenje lokalno napredovalega raka prostate v obliki monoterapije pri zgodnjem zdravljenju ali kot dodatek k zdravljenju z radioterapijo ali radikalno prostatektomijo pri bolnikih z rakom prostate.
Helsingborg Sweden
SE - 25110 Helsingborg Švedska