FrancophonIA/ELRC3.0 huggingface dataset:
English: In the long-term extension study of Protocol 018, 326 boys 9-15 years old during vaccination with Silgard in the base study, were followed.
Maltese: Fl-istudju ta' estensjoni fit-tul tal-Protokoll 018, ġew segwiti 326 tifel li kellhom minn 9-15-il sena meta tlaqqmu b'Silgard fl-istudju bażi.
English: At 36 month follow-up, the GMT in girls (2 doses, n = 86) remained non-inferior to the GMT in women (3 doses, n = 86) for all 4 HPV types.
Maltese: Wara 36 xahar ta' segwitu, il-GMT fil-bniet (2 dożi, n=86) baqgħet mhux inferjuri għall-GMT fin-nisa (3dożi, n=86) għall-4 tipi ta' HPV kollha.
English: Overall 12% of the combined study population had an abnormal Pap test suggestive of CIN at Day 1.
Maltese: B'kollox, 12% tal-popolazzjoni konġunta li kienet studjata kellha test anormali tal-Pap li jissuġġerixxi li kien hemm CIN f'Jum 1.
English: Very rarely (less than 1 in 10,000 patients), difficulty breathing (bronchospasm) has been reported.
Maltese: Rari ħafna (inqas minn pazjent wieħed minn kull 10,000 pazjent) diffikultà biex tieħu n-nifs (bronkospażmu) kienet irrappurtata.
English: However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunisation.
Maltese: Madankollu, il-preżenza ta' infezzjoni minuri, bħal infezzjoni ħafifa fl-apparat respiratorju ta' fuq jew deni mhux qawwi, mhix kontra-indikazzjoni għall-immunizzazzjoni.
English: What Silgard looks like and contents of the pack 1 dose of Silgard suspension for injection contains 0.5 ml.
Maltese: Doża waħda ta' Silgard suspensjoni għall-injezzjoni fiha 0.5 ml.
English: This assay measures antibodies against a single neutralizing epitope for each individual HPV type.
Maltese: Dan lassaġġ ikejjel l-anti-korpi kontra epitopu newtralizzanti wieħed għal kull tip individwali ta' HPV.
English: The efficacy for HPV 16/18-related CIN 2/3 or AIS is based on data from protocols 005 (16-related endpoints only), 007, 013, and 015.
Maltese: L-effikaċja għal CIN 2/3 jew AIS relatat ma' HPV 16/18 hija bbażata fuq it-tagħrif mill-protokolli 005 (16-il punt ta' tmiem relatat biss), 007, 013 u 015.
English: Alternatively, Silgard can be administered according to a 3-dose schedule:
Maltese: Għaldaqstant, Silgard jista' jintuża waqt it-treddigħ.
English: In post hoc analyses of individuals (who received at least one vaccination) with evidence of a prior infection with a vaccine HPV type (seropositive) no longer detectable (PCR negative) at vaccination onset, the efficacy of Silgard to prevent conditions due to the recurrence of the same HPV type was 100% (95% CI: 62.8, 100.0; 0 vs. 12 cases [n = 2572 from pooled studies in young women]) against HPV 6-, 11-, 16-, and 18-related CIN 2/3, VIN 2/3, VaIN 2/3, and genital warts in women 16 to 26 years.
Maltese: F'analiżi post hoc ta' individwi (li rċivew mill-anqas tilqima waħda) b'xhiedali kien hemm infezzjoni qabel b'tip ta' HPV (seropożittiv) tat-tilqima li ma nstabx aktar kif beda t-tilqim (negattiv għal PCR), l-effikaċja ta' Silgard biex tilqa' kontra kondizzjonijiet minħabba rikorrenza tal-istess tip ta' HPV kienet 100% (95% CI: 62.8, 100.
English: Silgard, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
Maltese: Silgard, suspensjoni għall-injezzjoni - siringa mimlija lesta mingħajr labra, pakkett ta' 1, 10, 20
English: Table 7 compares the 1 month Postdose 3 anti-HPV 6, 11, 16, and 18 GMTs in 9- to 15-year-old boys with those in 16- to 26-year-old men.
Maltese: Tabella 7 tqabbel il-GMTs ta' kontra HPV 6, 11, 16, u 18 fl-ewwel xahar ta' Wara d-Doża 3 f'subien b'età minn 9 sa 15-il sena ma' dik f'irġiel b'età minn 16 sa 26 sena.
English: Efficacy** at 2 years (95% CI)
Maltese: f'sena 2 (95% CI)
English: The efficacy of Silgard in 16- through 26-year-old men was assessed in 1 placebo-controlled, doubleblind, randomised Phase III clinical study (Protocol 020) including a total of 4,055 men who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Maltese: III, double-blind, randomised, ikkontrollat bil-plaċebo (Protokoll 020) li kien jiġbor fih total ta' 4,055 raġel li ddaħħlu fl-istudju u ġew imlaqqma mingħajr ma sarilhom eżami qabel dwar jekk kellhomx infezzjoni b'HPV.
English: Immunogenicity was related to age and Month 7 anti-HPV levels were significantly higher in younger individuals.
Maltese: L-immunoġeniċità kienet marbuta mal-età u l-livelli ta' kontra l-HPV fix-Xahar 7 kienu ogħla
English: The efficacy of Silgard in 16- through 26-year-old women was assessed in 4 placebo-controlled, double-blind, randomised Phase II and III clinical studies including a total of 20,541 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Maltese: L-effikaċja ta' Silgard f'nisa ta' bejn 16 u 26 sena ġiet evalwata f'4 provi kliniċi kkontrollati bilplaċebo, double-blind, randomised ta' Fażi
English: • Inject immediately using the intramuscular (IM) route, preferably in the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
Maltese: • Injetta immedjatament billi tuża r-rotta ta' ġol-muskolu (IM - intramuscular), preferibbilment fiż-żona deltojd tan-naħa ta' fuq tad-driegħ jew fiż-żona anterolaterali tannaħa ta' fuq tal-koxxa.
English: The impact of Silgard on rates of biopsy and treatment of EGL regardless of causal HPV types was evaluated in 2,545 individuals enrolled in Protocol 020.
Maltese: L-impatt ta' Silgard fuq ir-rati ta' biopsiji u kura ta' EGL kienu x'kienu t-tipi li kkawżaw HPV ġie stmat f'2,545 individwu li ddaħħlu fil-Protokoll 20.
English: Protection Against the Overall Burden of HPV disease in 16- Through 26-Year-Old Men
Maltese: Protezzjoni Kontra t-Tagħbija Globali ta' Mard b'HPV fi Rġiel b'Età minn 16 sa 26 Sena
English: The impact of Silgard against the overall risk for external genital lesions was evaluated after the first dose in 2,545 individuals enrolled in the Phase III efficacy trial (Protocol 020).
Maltese: L-impatt ta' Silgard kontra r-riskju globali ta' leżjonijiet ġenitali esterni kien stmat wara l-ewwel doża f'2,545 individwu mdaħħla fil-prova tal-effikaċja ta' Fażi
English: Silgard is a vaccine.
Maltese: Silgard hu vaċċin.
English: EXP MM/YYYY
Maltese: TWISSIJA(IET)SPEĊJALI
English: In these studies, individuals who were seronegative for anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 in the cLIA were still protected against clinical disease after a follow-up of 9 years for 16-23 year-old women, 10 years for 24-45 year-old women, and 10 years for 16-26 year-old men.
Maltese: F'dawn l-istudji, individwi li kienu seronegattivi kontra HPV 6, kontra HPV 11, kontra HPV 16, u kontra HPV 18 f'cLIA kienu għadhom protetti kontra mard kliniku wara segwitu ta' 9 snin għal nisa li kellhom minn 16-23 sena, 10 snin għal nisa li kellhom minn 24-45 sena, u 10 snin għal irġiel li
English: Silgard will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to a limited extent against diseases caused by certain related HPV types (see section 5.1).
Maltese: Silgard ser jipproteġi biss kontra l-mard ikkawżat mit-tipi 6, 11, 16 u 18 tal-HPV u sa ċertu punt, kontra l-mard ikkawżat minn ċerti tipi ta' HPV relatati (ara sezzjoni 5.1).
English: *Number of individuals with at least one follow-up visit after Month 7 **Based on virologic evidence, the first CIN 3 case in a patient chronically infected with HPV 52 is likely to be causally related to HPV 52.
Maltese: **Abbażi ta' evidenza viroloġika, l-ewwel każ ta' CIN 3 f'pazjent infettat kronikament b'HPV 52 x'aktarx li huwa każwalment relatat ma' HPV 52.
English: The impact of Silgard against the overall risk for cervical, HPV disease (i.e., disease caused by any HPV type) was evaluated starting 30 days after the first dose in 17,599 individuals enrolled in the two phase III efficacy trials (Protocols 013 and 015).
Maltese: L-impatt ta' Silgard kontra r-riskju globali għal mard HPV (jiġifieri mard ikkawżat minn kwalunkwe tip ta' HPV) ġie evalwat wara 30 jum mill-ewwel doża fi 17,599 individwu reġistrati fiż-żewġ provi ta' l-effikaċja ta' fażi
English: Silgard, suspension for injection in a pre-filled syringe.
Maltese: Silgard, suspensjoni għall-injezzjoni f'siringa mimlija lesta.
English: • Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and
Maltese: • Iġbed id-doża ta' 0.5 ml tal-vaċċin mill-kunjett ta' doża waħda permezz ta' labra u siringa sterili.
English: The efficacy for all other endpoints is based on protocols 007, 013, and 015.
Maltese: L-effikaċja għall-punti ta' tmiem l-oħrajn kollha hija bbażata fuq il-protokolli 007, 013, u 015.
English: During clinical trials, dizziness was observed as a common adverse reaction in females.
Maltese: Waqt provi kliniċi, kien osservat sturdament bħala reazzjoni avversa komuni fin-nisa.
English: Tel: +386 1 5204 201 msd.slovenia@merck.com
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 5204 201 msd.slovenia@merck.com dkmail@merck.com
English: There were no significant differences in types of anomalies or proportion of pregnancies with an adverse outcome in Silgard and placebo treated individuals.
Maltese: Ma kien hemm ebda differenza sinifikanti f'tipi ta' anomaliji jew proporzjonijiet ta' tqaliet b'riżultat avvers f'individwi ikkurati b'Silgard u f'dawk ikkurati bi plaċebo.
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related External Genital Lesions) were observed through 10.6 years (median follow-up of
Maltese: Fil-popolazzjoni PPE, ma kienu osservati l-ebda każijiet ta' mard b'HPV (Feriti Ġenitali Esterni marbuta ma' tipi 6/11/16/18 ta' HPV) sa 10.6 snin (medjan ta'
English: This is based on the results from a clinical trial in which a combined dTap-IPV vaccine was administered concomitantly with the first dose of Silgard (see section 4.8).
Maltese: Dan huwa bbażat fuq ir-riżultati minn prova klinika li fiha, vaċċin dTap-IPV ikkombinat ingħata fl-istess ħin mal-ewwel doża ta' Silgard (ara sezzjoni 4.8).
English: Antibodies against all four HPV types were transferred to the offspring during gestation and possibly during lactation.
Maltese: Anti-korpi kontra l-erba' tipi kollha ta' HPV kienu trasferiti lill-frieħ matul it-tqala u possibbilment waqt it-treddigħ.
English: Skin and subcutaneous tissue disorders:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
English: Among women with an abnormal Pap test at Day 1 who were already infected with the relevant vaccine HPV types at Day 1, no vaccine efficacy was
Maltese: Fost nisa li kellhom test anormali tal-Pap f'Jum 1 li kienu diġà infettati bit-tipi tal-vaċċin HPV rilevanti f'Jum 1, l-ebda
English: Duration of protection of a 2-dose schedule of Silgard has not been established.
Maltese: Għadu ma ġiex stabbilit it-tul tal-protezzjoni bi skeda ta' 2 dożi ta' Silgard.
English: Efficacy in women with evidence of HPV 6, 11, 16, or 18 infection or disease at day 1
Maltese: Effikaċja f'nisa b'evidenza ta' infezzjoni jew marda b'HPV 6, 11, 16 jew 18 f'jum 1.
English: Hypersensitivity to the active substances or to any of the excipients.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti.
English: Please speak to your doctor for more information.
Maltese: Jekk jogħġbok kellem lit-tabib tiegħek għal aktar informazzjoni.
English: Girls and boys vaccinated with Silgard at 9-15 years of age in Protocol 018 base study were followed up in an extension study.
Maltese: Subien u bniet imlaqqma b'Silgard f'età ta' 9-15-il sena fl-istudju bażi tal-Protokoll 018 ġew segwiti fi studju ta' estensjoni.
English: The efficacy of Silgard against HPV 6-, 11-, 16-, 18-related external genital warts was 68.1% (95% CI: 48.8, 79.3).
Maltese: L-effikaċja ta' Silgard kontra l-inċidenza kombinata ta' infezzjoni, felul ġenetali, leżjonijiet vulvari u vaġinali, persistenti relatati ma' HPV 6, 11, 16 jew 18, CIN ta' kwalunkwe grad, AIS u kanċers ċervikali kienet 88.7% (95% CI: 78.1, 94.8).
English: In the long-term extension study of Protocol 020, 917 men 16-26 years old during vaccination with Silgard in the base study, were followed.
Maltese: Fl-istudju ta' estensjoni fit-tul tal-Protokoll 020, ġew segwiti 917-il raġel li kellhom minn 16-26 sena meta tlaqqmu b'Silgard fl-istudju bażi.
English: In a supplemental analysis, the efficacy of Silgard was evaluated against HPV 16/18-related CIN 3 and
Maltese: F'analiżi supplimentali, l-effikaċja ta' Silgard ġiet evalwata kontra CIN 3 u AIS relatati ma' HPV
English: The efficacy of Silgard in 24- through 45-year-old women was assessed in 1 placebo-controlled, double-blind, randomised Phase III clinical study (Protocol 019, FUTURE III) including a total of 3,817 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Maltese: II u III, li kienu jinkludu total ta' 20,541 mara, li kienu rreġistrati u vaċċinati mingħajr screening minn qabel, għall-preżenza ta' infezzjoni tal-HPV.
English: At Month 7, in the Per Protocol population, the immune response in girls aged 9-13 years (n = 241) who received 2 doses of Silgard (at 0, 6 months) was non-inferior and numerically higher to the immune response in women aged 16-26 years (n = 246) who received 3 doses of Silgard (at 0, 2,
Maltese: Fix-Xahar 7, fil-popolazzjoni Skont il-Protokoll, ir-rispons immuni fi bniet b'età minn 9 snin sa 13-il sena (n=241) li rċivew 2 dożi ta' Silgard (fix-xhur 0 u 6) ma kienx inferjuri u kien numerikament ogħla mir-rispons immuni f'nisa b'eta minn 16 sa 26 sena (n=246) li rċivew 3 dożi ta' Silgard (fixxhur 0, 2 u 6).
English: AntiHBs geometric mean antibody titres were lower on co-administration, but the clinical significance of
Maltese: It-titres medji ġeometriċi ta' l-anti-korpi ta' kontra l-HBs kienu inqas fl-għoti flimkien, iżda s-sinifikat kliniku ta' din l-osservazzjoni mhux magħruf.
English: Trevicta paliperidone
Maltese: paliperidone
English: Trevicta is available as a prolonged-release suspension for injection in pre-filled syringes (175 mg, 263 mg, 350 mg and 525 mg).
Maltese: Trevicta huwa disponibbli bħala sospensjoni ta' rilaxx fit-tul għal injezzjoni f'siringi mimlijin għal-lest (175 mg, 263 mg, 350 mg, 100 mg u 525 mg).
English: The full EPAR and risk management plan summary for Trevicta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Trevicta
Maltese: Informazzjoni oħra dwar Trevicta
English: 1 Previously known as Paliperidone Janssen.
Maltese: 1 Qabel kien magħruf bħala Paliperidone Janssen.
English: In the second study (in 305 patients) Trevicta was more effective than placebo (a dummy treatment), with 9% of patients given the medicine suffering a relapse of their condition compared with 29% of those on placebo.
Maltese: Fit-tieni studju (fi 305 pazjenti), Trevicta kien iktar effettiv minn plaċebo (kura finta), b'9% tal-pazjenti li ngħataw il-mediċina sofrew minn rikaduta tal-kundizzjoni tagħhom meta mqabbla ma' 29% ta' dawk fuq plaċebo.
English: Trevicta contains the active substance paliperidone.
Maltese: Trevicta fih is-sustanza attiva paliperidone.
English: The name of the medicine was changed to Trevicta on 26 May 2016.
Maltese: L-isem tal-mediċina nbidel għal Trevicta fis-26 ta' Marzu 2016.
English: This is a summary of the European public assessment report (EPAR) for Trevicta.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Trevicta.
English: The active substance in this medicine, paliperidone, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'din il-mediċina, paliperidone, hija mediċina antipsikotika.
English: Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Maltese: Paliperidone jaġixxi prinċipalment billi jimblokka lir-riċetturi tannewrotransmittur dopamine, 5-hydroxytryptamine (imsejjaħ ukoll serotonin).
English: Why is Trevicta approved?
Maltese: Għaliex ġie approvat Trevicta?
English: What are the risks associated with Trevicta?
Maltese: X'inhuma r-riskji assoċjati ma' Trevicta?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Paliperidone Janssen on 5 December 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Paliperidone Janssen fil-5 ta' Diċembru 2014.
English: The most common side effects with Trevicta (seen in at least 5 in 100 patients) are insomnia (difficulty sleeping), headache, anxiety, upper respiratory tract infections (such as colds), reactions at the site of injection and increased weight.
Maltese: L-aktar effetti sekondarji serji bi Trevicta (li dehru f'mill-inqas 5 pazjenti minn kull 100 pazjent) huma insomnija (diffikultà fl-irqad), uġigħ ta' ras, ansjetà, infezzjonijiet fil-parti ta' fuq tal-passaġġ respiratorju (bħal irjiħat), reazzjonijiet fis-sit tal-injezzjoni u żieda fil-piż.
English: This authorisation was based on the authorisation granted to Xeplion in 2011 (‘informed consent').
Maltese: Din l-awtorizzazzjoni hija bbażata fuq l-awtorizzazzjoni mogħtija għal Xeplion fl-2011 (‘kunsens infurmat').
English: A risk management plan has been developed to ensure that Trevicta is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Trevicta jintuża bl-aktar mod sigur possibbli.
English: In one of them (involving 1,016 patients) Trevicta was as effective as paliperidone monthly injections in preventing relapses of schizophrenia.
Maltese: F'wieħed minnhom (li involva 1,016-il pazjent), Trevicta kien effettiv daqs injezzjonijiet ta' paliperidone kull xahar fil-prevenzjoni ta' rikaduti taliskizofrenija.
English: Trevicta is an antipsychotic medicine used for the maintenance treatment of schizophrenia in adults whose disease has been stable on treatment with once-monthly injections of paliperidone.
Maltese: Trevicta huwa mediċina antipsikotika użata għall-kura ta' manteniment tal-iskizofrenja f'adulti li lmarda tagħhom diġà ġiet stabbilizzata b'kura b'injezzjonijiet darba fix-xahar ta' paliperidone.
English: Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Maltese: Paliperidone huwa prodott tat-tkissir (metabolit) attiv ta' risperidone, mediċina antipsikotika oħra li ilha tintuża fil-kura tal-iskizofrenija sa mis-snin disgħin.
English: The symptoms of schizophrenia include disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Maltese: Issintomi tal-iskizofrenija jinkludu ħsibijiet u diskors diżorganizzati, alluċinazzjonijiet (tisma' jew tara affarijiet li mhumiex hemm), suspetti u delużjonijiet (twemmin falz).
English: Paliperidone has been authorised in the European Union (EU) as Invega since 2007 for use by mouth to treat schizophrenia.
Maltese: Paliperidone ilu awtorizzat fl-Unjoni Ewropea (UE) bħala Invega mill-2007 għal użu mill-ħalq għall-kura tal-iskizofrenja.
English: Trevicta, which is given by injection every 3 months, is more effective than placebo and as effective as paliperidone monthly injection in preventing relapses of schizophrenia.
Maltese: Trevicta, li jingħata b'injezzjoni kull 3 xhur, huwa iktar effettiv minn plaċebo u huwa effettiv daqs injezzjonijiet ta' paliperidone kull xahar fil-prevenzjoni ta' rikaduti tal-iskizofrenija.
English: What measures are being taken to ensure the safe and effective use of Trevicta?
Maltese: X'miżuri qed jitteħdu biex jassiguraw l-użu sigur u effikaċi ta' Trevicta?
English: In the brain, paliperidone attaches to several different receptors on the surface of nerve cells.
Maltese: Fil-moħħ, paliperidone jeħel ma' diversi riċetturi differenti fuq issuperfiċje taċ-ċelloli tan-nervituri.
English: For the full list of all side effects reported with Trevicta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Trevicta, ara l-fuljett ta' tagħrif.
English: It has also been authorised as Xeplion since 2011 for use by monthly injections for the maintenance treatment of schizophrenia.
Maltese: Ilu awtorizzat ukoll bħala Xeplion sa mill-2011 sabiex jintuża b'injezzjonijiet kull xahar għall-kura ta' manteniment tal-iskizofrenija.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that paliperidone injections are effective in treating schizophrenia symptoms.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Mill-Bniedem (CHMP) tal-Aġenzija nnota li injezzjonijiet ta' paliperidone huma aktar effettivi fil-kura ta' sintomi tal-iskizofrenja.
English: It is not intended to provide practical advice on how to use Trevicta.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Trevicta.
English: Probability of survival (%)
Maltese: Probabbiltà ta' sopravivenza (%)
English: Safety data for Black and African American patients are limited.
Maltese: Dejta tas-sigurtà għal pazjenti Amerikani u Afrikani Suwed hi limitata.
English: Placebo Nintedanib
Maltese: Plaċebo Nintedanib
English: Vargatef + Docetaxel Placebo + Docetaxel
Maltese: Vargatef + Docetaxel Plaċebo + Docetaxel
English: 120 x 1 soft capsule
Maltese: 120 x 1 kapsula ratba
English: In addition Fms-like tyrosine-protein kinase (Flt)-3, lymphocyte-specific tyrosine-protein kinase (Lck) and proto-oncogene tyrosine-protein kinase Src (Src) are inhibited.
Maltese: Flimkien ma' dan, Fms-like tyrosine-protein kinase (Flt)-3, Lymphocyte-specific tyrosine-protein kinase (Lck) u proto-oncogene tyrosine-protein kinase Src (Src) jiġu inibiti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 November 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 ta' Novembru 2014
English: Myocardial infarction (see section 4.4)
Maltese: Infart mijokardijaku (ara sezzjoni 4.4)
English: Date of latest renewal: 26 August 2019
Maltese: Data tal-aħħar tiġdid: 26 ta' Awwissu 2019
English: The absolute bioavailability of a 100 mg dose was 4.69 % (90 % CI: 3.615 - 6.078) in healthy volunteers.
Maltese: Il-bijodisponibilità assoluta ta' doża ta' 100 mg kienet ta' 4.69 %(90 % CI: 3.615-6.078 ) f'voluntiera b'saħħithom.
English: After intravenous infusion, a high volume of distribution (Vss: 1050 L, 45.0 % gCV) was observed.
Maltese: Wara infużjoni fil-vini, ġie osservat volum għoli ta' distribuzzjoni (Vss : 1,050 L, 45.0 % gCV).
English: Stratified Log-Rank Test p-value** Progression free survival (PFS)*** - follow-up analysis Patients, n
Maltese: Valur p stratifikat tat-Test Log-Rank** Sopravivenza ħielsa minn progressjoni (PFS)*** - analiżi follow-up Pazjenti, n
English: Mucositis (including stomatitis), Rash, Alopecia
Maltese: Mukożite (li tinkludi stomatite), Raxx, Alopeċja
English: BIBF 1202 is subsequently glucuronidated by UGT enzymes, namely UGT 1A1, UGT 1A7, UGT 1A8, and UGT 1A10 to BIBF 1202 glucuronide.
Maltese: BIBF 1202 sussegwentement jiġi glukuronidat minn enzimi UGT, jiġifieri UGT 1A1, UGT 1A7, UGT 1A8, u UGT 1A10 għal BIBF 1202 glucuronide.
English: Capsule content Triglycerides, medium-chain Hard fat
Maltese: Kontenut tal-kapsula Triglycerides, medium-chain Xaħam iebes
English: Vargatef 150 mg soft capsules Pack-size: 60 capsules.
Maltese: Vargatef 150 mg kapsuli rotob Daqs tal-pakkett: 60 kapsula.
English: Therapeutic anticoagulation
Maltese: Antikoagulazzjoni terapewtika
English: Diarrhoea occurred in 43.4 % (≥ grade 3: 6.3 %) of adenocarcinoma patients in the nintedanib arm.
Maltese: Id-dijarea seħħet fi 43.4 % (≥ grad 3: 6.3 %) ta' pazjenti b'adenokarċinoma fil-parti tal-istudju dwar nintedanib.
English: Dose proportionality was shown by increase of nintedanib exposure (dose range 50 - 450 mg once daily and 150 - 300 mg twice daily).
Maltese: Il-proporzjonalità tad-doża ntweriet biż-żieda tal-esponiment ta' nintedanib (medda tad-doża 50-450 mg darba kuljum u 150-300 mg darbtejn kuljum).