Efient Den europeiske union - maltesisk - EMA (European Medicines Agency)

efient

substipharm - prasugrel - acute coronary syndrome; angina, unstable; myocardial infarction - aġenti antitrombotiċi - efient, ko amministrati bl-aċidu aċetilsaliċiliku (asa), huwa indikat għall-prevenzjoni ta ' avvenimenti ta ' atherothrombotic fil-pazjenti bl-sindromu coronary akuta (i. anġina instabbli, mhux-st-segment-elevazzjoni myocardial infarzjoni [ua / nstemi] jew st-segment-elevazzjoni myocardial infarzjoni [stemi]) li jkunu għaddejjin minn intervent coronary perkutanja (pci) ta ' primarja jew mdewma.

Feraccru Den europeiske union - maltesisk - EMA (European Medicines Agency)

feraccru

norgine b.v. - maltol ferriku - anemija, deficjenza tal-Ħadid - preparazzjonijiet antianemiċi - feraccru huwa indikat fl-adulti għall-kura ta 'defiċjenza ta' ħadid.

Giotrif Den europeiske union - maltesisk - EMA (European Medicines Agency)

giotrif

boehringer ingelheim international gmbh - afatinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - giotrif bħala monoterapija hija indikata għat-trattament ofepidermal growth factor receptor (egfr) tki pazjenti adulti naΐve għal kura bil-lokalment avvanzat jew dak metastatiku li mhux ta 'ċelluli żgħar kanċer tal-pulmun (nsclc) ma' l-attivazzjoni tal-egfr-mutazzjoni tal - (s);lokalment avvanzat jew metastatiku nsclc tal-kanser skwamuż tar-istoloġija tal-progress fuq jew wara ibbażat fuq il-platinu ' kimoterapija.

Glubrava Den europeiske union - maltesisk - EMA (European Medicines Agency)

glubrava

takeda pharma a/s - metformin hydrochloride, pioglitazone hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - glubrava huwa indikat bħala kura tat-tieni linja ta 'pazjenti adulti tat-tip-2-diabetes-mellitus, speċjalment pazjenti b'piż żejjed, li ma jistgħux jiksbu kontroll glikimiku suffiċjenti bid-doża massima ttollerata ta' metformin orali waħdu. wara l-bidu tat-terapija b'pioglitazone, il-pazjenti għandhom jiġu riveduti wara tlieta sa sitt xhur biex tevalwa l-adegwatezza tal-rispons għall-kura (e. it-tnaqqis fl-hba1c). f'pazjenti li jonqsu li juru rispons adegwat, pioglitazone għandu jitwaqqaf. fid-dawl tar-riskji potenzjali fit-tul mal-terapija, it-tobba għandhom jikkonfermaw fil-sussegwenti ta 'rutina reviżjonijiet li l-benefiċċju ta' pioglitazone jinżamm.

Broadline Den europeiske union - maltesisk - EMA (European Medicines Agency)

broadline

boehringer ingelheim vetmedica gmbh - eprinomectin, fipronil, praziquantel, (s) -methoprene - antiparasitic products, insecticides and repellents, avermectins, eprinomectin, combinations, - qtates - għall-qtates, jew f'riskju minn infestazzjonijiet imħallta permezz ta 'ċestodi, nematodi u ektoparassiti. il-prodott mediċinali veterinarju huwa esklussivament indikat meta l-tliet gruppi huma maħsuba fl-istess ħin. ectoparasitestreatment u l-prevenzjoni ta ' infestazzjonijiet minn briegħed (ctenocephalides felis). l-eliminazzjoni tal-briegħed fi żmien 24 siegħa. trattament wieħed jippreveni t-infestazzjonijiet għal mill-inqas xahar. il-prevenzjoni ta'l-ambjent tal-briegħed-kontaminazzjoni billi jinibixxi l-iżvilupp tal-briegħed immaturi-istadji (bajd, il-larva u l-pupi) għal aktar minn xahar. il-prodott jista 'jintuża bħala parti minn strateġija ta' trattament għall-kontroll tad-dermatite tal-allerġija tal-briegħed (fad). it-trattament u l-prevenzjoni ta ' infestazzjonijiet bil-qurdien (ixodes ricinus). l-eliminazzjoni tal-qurdien fi żmien 48 siegħa. trattament wieħed jippreveni t-infestazzjonijiet sa 3 ġimgħat. it-trattament tal-notoedric mange (notoedres cati). cestodestreatment ta ' infestazzjonijiet bil-dud (dipylidium caninum, taenia taeniaeformis, echinococcus multilocularis, joyeuxiella pasqualei (adulti), u joyeuxiella fuhrmanni (adulti)). nematodestreatment ta ' infestazzjonijiet bil-ħniex gastro-intestinali (l3, l4-larva u l-adulti tal-toxocara cati, adulti tat-toxascaris leonina, larva l4 u l-adulti tal-ancylostoma tubaeforme u ancylostoma ceylanicum, u l-adulti tal-ancylostoma brazilienze). it-trattament ta ' infestazzjonijiet bil-feline lungworms (larva l3, l4-larva u l-adulti tal-aelurostrongylus abstrusus, larva l4 u l-adulti tal-troglostrongylus brevior). it-trattament ta ' infestazzjonijiet bil-vesical dud (capillaria plica). il-prevenzjoni tal-mard tal-heartworm (dirofilaria immitis larva) għal xahar.

Imatinib Accord Den europeiske union - maltesisk - EMA (European Medicines Agency)

imatinib accord

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. Ħlief fil għadhom kif ġew dijanjostikati cml ta ' fażi kronika, m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard. .

Imatinib medac Den europeiske union - maltesisk - EMA (European Medicines Agency)

imatinib medac

medac - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; leukemia, myelogenous, chronic, bcr-abl positive; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome - inibituri tal-proteina kinase - imatinib medac huwa indikat għall-kura ta': pazjenti pedjatriċi li jkunu għadhom kif ġew dijanjostikati-kromosoma ta 'filadelfja (bcr-abl) positive (ph+) lewkimja kronika tal-majelojd (cml) li għalihom trapjant tal-mudullun ma jkunx meqjus bħala l-ewwel linja ta' trattament;pazjenti pedjatriċi b'ph+cml fil-fażi kronika wara l-falliment ta ' l-interferon-alpha-terapija, jew fil-fażi aċċelerata;pazjenti adulti u pedjatriċi b'ph+cml fi blast crisis;pazjenti adulti u pedjatriċi li jkunu għadhom kif ġew dijanjostikati philadelphia chromosome positive li għandhom lewkimja limfoblastika akuta (ph+all) integrata b'kimoterapija;pazjenti adulti b'all rikadut jew refrattarju ph+all bħala monoterapija;pazjenti adulti b'mard majelodisplastiku/majeloproliferattiv (mds/mpd) assoċjat ma ' plejtlits-riċettur tal-fattur tat-tkabbir derivat (pdgfr) ġeni mill-ġdid l-arranġamenti;pazjenti adulti b'avvanzati sindrome ipereżinofiliku (hes) u/jew lewkimja kronika eosinofilika (cel) b'fip1l1-pdgfra arranġament mill-ġdid;il-pazjenti adulti li ma jistax jitneħħa dermatofibrosarcoma protuberans (dfsp) u pazjenti adulti bil-rikorrenti u/jew metastatiku dfsp li mhumiex eliġibbli għall-kirurġija. l-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. f'pazjenti adulti u pedjatriċi, l-effikaċja ta 'imatinib hija bbażata fuq globali ematoloġiċi u ċitoġenetiċi-rati ta' rispons u sopravivenza mingħajr progressjoni f'cml, fuq ematoloġiċi u ċitoġenetiċi-rati ta 'rispons f'ph+all, mds/mpd, fuq il-rati ta' rispons ematoloġiku f'hes/cel u dwar l-objettiv tal-rati ta ' rispons fil-pazjenti adulti li ma jistax jitneħħa u/jew metastiku dfsp. l-esperjenza b'imatinib f'pazjenti b'mds/mpd assoċjati ma ' tibdil fil-ġene pdgfr hija limitata ħafna. Ħlief fil għadhom kif ġew dijanjostikati cml ta ' fażi kronika, m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

Imbruvica Den europeiske union - maltesisk - EMA (European Medicines Agency)

imbruvica

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli) Den europeiske union - maltesisk - EMA (European Medicines Agency)

porcilis porcoli diluvac forte (previously porcilis porcoli)

intervet international bv - f4ab (k88ab) fimbrial adhesin, f4ac (k88ac) fimbrial adhesin, f5 (k99) fimbrial adhesin, f6 (987p) fimbrial adhesin, lt-tossojde - immunoloġiċi - majjali (ħnieżer nisa u majjali nisa) - għall-immunizzazzjoni passiva ta 'qżieqeż permezz ta' tilqim attiv ta 'ħnieżer nisa / majjali żgħar biex titnaqqas il-mortalità u sinjali kliniċi bħal dijarrea minħabba enterotossikosi tat-twelid matul l-ewwel jiem tal-ħajja, ikkawżati minn dawk e. coli li jesprimu l-adesivi fimbrial f4ab (k88ab), f4ac (k88ac), f5 (k99) jew f6 (987p).

Quadrisol Den europeiske union - maltesisk - EMA (European Medicines Agency)

quadrisol

vetcool b.v. - vedaprofen - anti-infjammatorji u anti-rewmatiċi-prodotti - Żwiemel - tnaqqis ta 'infjammazzjoni u eżenzjoni ta' uġigħ assoċjat ma 'mard muskuloskeletali u leżjonijiet tat-tessut artab (korrimenti trawmatiċi u trawma kirurġika). f'każijiet ta 'trawma kirurġika antiċipata, quadrisol jista' jingħata profilattiku mill-inqas tliet sigħat qabel l-operazzjoni elettiva.