FrancophonIA/ELRC3.0 huggingface dataset:
English: In these studies CTCAE Grade 3 hypokalaemia occurred in 1.1% and 0.4% of sorafenib treated patients and 0.2% and 0.7% of patients in the placebo group.
Maltese: CTCAE Grad 3 seħħet f'1.1 % u 0.4 % tal-pazjenti kkurati b'sorafenib u f'0.2 % u 0.7 % tal-pazjenti fil-grupp tal-plaċebo.
English: In the pre-specified stratification factors (ECOG status, presence or absence of macroscopic vascular invasion and/or extrahepatic tumour spread) of both Study 3 and 4, the HR consistently favoured sorafenib over placebo.
Maltese: Fil-fatturi ta' stratifikazzjoni speċifikati minn qabel (stat ECOG, preżenza jew nuqqas ta' invażjoni vaskulari makroskopika u/jew firxa tat-tumur barra mill-fwied) ta' l-Istudji 3 u 4, l-HR iffavorixxa b'mod konsistenti lil sorafenib fuq plaċebo.
English: Concomitant treatment with sorafenib resulted in a 21 % increase in the AUC of doxorubicin.
Maltese: Kura flimkien ma' sorafenib wassal għal żjieda ta' 21 % fl-AUC ta' doxorubicin.
English: Differentiated thyroid carcinoma
Maltese: Karċinoma differenzjata tat-tirojde
English: Temporary or permanent discontinuation of sorafenib should be considered in patients who develop cardiac ischaemia and/or infarction (see section 4.8).
Maltese: Twaqqif temporanju jew permanenti ta' sorafenib għandu jiġi kkunsidrat f'pazjenti li żviluppaw iskemija u/jew infart tal-qalb (ara sezzjoni 4.8).
English: Hand foot skin reaction (palmar-plantar erythrodysaesthesia) and rash represent the most common adverse drug reactions with sorafenib.
Maltese: Reazzjoni tal-ġilda fl-id u s-sieq (eritrodisasteżija palmari-plantari) u raxx jirrappreżentaw l-aktar reazzjonijiet avversi komuni tal-mediċina b'sorafenib.
English: Cardiac ischaemia and/or infarction
Maltese: Iskemija u/jew infart tal-qalb
English: No studies have been conducted to investigate the pharmacokinetics of sorafenib in paediatric patients.
Maltese: Ma sarux studji biex jinvestigaw il-farmakokinetika ta' sorafenib f'pazjenti pedjatriċi.
English: Nexavar 200 mg film-coated tablets sorafenib
Maltese: Nexavar 200 mg pilloli miksija b'rita sorafenib
English: Gastrointestinal perforation is an uncommon event and has been reported in less than 1% of patients taking sorafenib.
Maltese: Perforazzjoni gastro-intestinali hija avveniment mhux komuni u ġiet irrappurtata f'inqas minn 1% talpazjenti li qed jieħdu sorafenib.
English: Blood and lymphatic system disorders lymphopenia leucopenia neutropenia anaemia thrombocytopenia
Maltese: Disturbi taddemm u tas sistema limfatika limfopenja lewkopenja newtropenja anemija tromboċitopenja
English: An increased risk of bleeding may occur following sorafenib administration.
Maltese: Żjieda fir-riskju ta' fsada tista' sseħħ wara amministrazzjoni ta' sorafenib.
English: Co-administration of neomycin or other antibiotics that cause major ecological disturbances of the gastrointestinal microflora may lead to a decrease in sorafenib bioavailability (see section 4.5).
Maltese: L-għoti flimkien ta' neomycin jew antibijotiċi oħra li jikkawżaw disturbi maġġuri ekoloġiċi talmikroflora gastro-intestinali jista' jwassal għal tnaqqis fil-bijodisponibiltà ta' sorafenib (ara sezzjoni 4.5).
English: Since sorafenib is mainly eliminated via the hepatic route exposure might be increased in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Maltese: Minħabba li sorafenib jiġi eliminat prinċipalment mir-rotta epatika, l-espożizzjoni tista' tiżdied f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.2 u 5.2).
English: In vitro studies of CYP enzyme induction
Maltese: Studji in vitro ta' l-induzzjoni ta' l-enżima CYP
English: Dermatological toxicities
Maltese: GĦAMLA FARMAĊEWTIKA
English: No data is available on patients with Child Pugh C (severe) hepatic impairment.
Maltese: M'hemmx tagħrif disponibbli dwar pazjenti b'indeboliment epatiku Child Pugh C (sever).
English: High Risk Patients, according to MSKCC (Memorial Sloan Kettering Cancer Center) prognostic group, were not included in the phase III clinical study in renal cell carcinoma (see study 1 in section 5.1), and benefit-risk in these patients has not been evaluated.
Maltese: Pazjenti f'Riskju Għoli, skont il-grupp pronjostiku MSKCC (Memorial Sloan Kettering Cancer Center), ma ġewx inklużi fl-istudju kliniku ta' fażi
English: Some medicines may affect Nexavar, or be affected by it. Tell your doctor or pharmacist if you are taking, have recently taken or might take anything in this list or any other medicines, including medicines obtained without a prescription: - Rifampicin, Neomycin or other medicines used to treat infections (antibiotics) - St John's wort, a herbal treatment for depression - Phenytoin, carbamazepine or phenobarbital, treatments for epilepsy and other conditions - Dexamethasone, a corticosteroid used for various conditions - Warfarin or phenprocoumon, anticoagulants used to prevent blood clots - Doxorubicin, capecitabine, docetaxel, paclitaxel and irinotecan, which are cancer treatments - Digoxin, a treatment for mild to moderate heart failure
Maltese: - Rifampicin, Neomycin jew mediċini oħra użati biex jikkuraw infezzjonijiet (anti-bijotiċi) - St John's wort, kura mill-ħxejejx għad-depressjoni - Phenytoin, carbamazepine jew phenobarbital, kura għall-epilessija u kundizzjonijiet oħra - Dexamethasone, kortikosterojd użat f'diversi kundizzjonijiet - Warfarin jew phenprocoumon, antikoagulanti wżati biex jipprevjenu emboli tad-demm
English: No dose adjustment is required in patients with Child Pugh A or B (mild to moderate) hepatic impairment.
Maltese: L-ebda aġġustament fid-doża ma hija neċessarja f'pazjenti b'indeboliment epatiku Child Pugh A jew B (ħafif sa moderat).
English: may affect up to 1 in 10 people - flu-like illness - indigestion (dyspepsia) - difficulty swallowing (dysphagia) - inflamed or dry mouth, tongue pain (stomatitis and mucosal inflammation) - low calcium levels in the blood (hypocalcaemia) - low potassium levels in the blood (hypokalaemia) - low blood sugar level (hypoglycaemia) - muscle pain (myalgia) - disturbed sensations in fingers and toes, including tingling or numbness (peripheral sensory neuropathy) - depression - erection problems (impotence) - altered voice (dysphonia) - acne - inflamed, dry or scaly skin that sheds (dermatitis, skin desquamation) - heart failure - heart attack (myocardial infarction) or chest pain - tinnitus (ringing sound in the ear) - kidney failure - abnormally high levels of protein in the urine (proteinuria) - general weakness or loss of strength (asthenia) - decrease in the number of white blood cells (leucopenia and neutropenia) - decrease in the number of red blood cells (anaemia) - low number of platelets in the blood (thrombocytopenia) - inflammation of hair follicles (folliculitis) - underactive thyroid gland (hypothyroidism) - low sodium levels in the blood (hyponatraemia) - distortion of the sense of taste (dysgeusia) - red in the face and often other areas of the skin (flushing) - runny nose (rhinorrhoea) - heartburn (gastro oesophageal reflux disease) - skin cancer (keratoacanthomas/squamous cell cancer of the skin) - a thickening of the outer layer of the skin (hyperkeratosis) - a sudden, involuntary contraction of a muscle (muscle spasms)
Maltese: - glandola tat-tirojde mhux attiva biżżejjed (ipotirojdiżmu) - livelli baxxi ta' sodium fid-demm (iponatremija) - tibdil fis-sens tat-togħma (disġewżja) - ħmura fil-wiċċ u ta' spiss f'żoni oħrajn tal-ġilda (fwawar) - imnieħer inixxi (rinoreja) - qrusa fl-istonku (marda ta' rifluss gastroesofagali) - kanċer tal-ġilda (keratoakantomi/kanċer taċ-ċelluli skwamużi tal-ġilda) - is-saff ta' barra tal-ġilda jeħxien (iperkeratożi) - kontrazzjoni għall-għarrieda u involontarja ta' muskolu (spażmi fil-muskoli)
English: Co-administration of neomycin, a non-systemic antimicrobial agent used to eradicate gastrointestinal flora, interferes with the enterohepatic recycling of sorafenib (see section 5.2, Metabolism and Elimination), resulting in decreased sorafenib exposure.
Maltese: L-għoti flimkien ta' neomycin, sustanza mhux sistemika kontra l-mikrobi wżata biex teqred flora gastro-intestinali, jinterferi mar-riċiklaġġ entero-epatiku ta' sorafenib (ara sezzjoni 5.2, Metaboliżmu u
English: - If you are taking Neomycin or other antibiotics.
Maltese: - Jekk qed tieħu Neomycin jew antibijotiċi oħra.
English: Hepatocellular carcinoma
Maltese: enċefalopatija°
English: In study 100554 (HCC), 0.99% of those treated with sorafenib and 1.1% receiving placebo were reported with these events.
Maltese: (HCC), 0.99% ta' dawk ikkurati b'sorafenib u 1.1% li rċevew plaċebo kienu rrapportati b'dawn l-avvenimenti.
English: Package Leaflet: Information for the user Nexavar 200 mg film-coated tablets sorafenib
Maltese: Informazzjoni għall-utent Nexavar 200 mg pilloli miksija b'rita sorafenib
English: The safety and efficacy of Nexavar in children and adolescents aged < 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Nexavar fit-tfal u l-adoloxxenti b'età < 18-il sena għadhom ma ġewx determinati s'issa.
English: Monitoring of fluid balance and electrolytes in patients at risk of renal dysfunction is advised.
Maltese: Hija rrakkomandata sorveljanza tal-bilanċ ta' fluwidu u elettroliti f'pazjenti li għandhom riskju ta' funzjoni renali ħażina.
English: Patients were included in the study if they experienced progression within 14 months of enrollment and had DTC refractory to radioactive iodine (RAI).
Maltese: Il-pazjenti ġew inklużi fl-istudju jekk kellhom progressjoni fi żmien 14-il xahar mir-reġistrazzjoni u kellhom DTC refrattarja għal iodine radjuattiv (RAI - radioactive iodine).
English: Renal cell carcinoma
Maltese: Karċinoma epatoċellulari
English: Coadministration of neomycin has been shown to interfere with this process, decreasing the mean bioavailability of sorafenib by 54%.
Maltese: Intwera li l-għoti flimkien ta' neomycin jinterferi ma' dan ilproċess u jnaqqas il-bijodisponibiltà medja ta' sorafenib b'54%.
English: The effect of sorafenib on PFS was consistent independent of geographic region, age above or below 60 years, gender, histological subtype, and presence or absence of bone metastasis.
Maltese: L-effett ta' sorafenib fuq PFS kien konsistenti, indipendentement mir-reġjun ġeografiku, età ta' iktar jew inqas minn 60 sena, sess, sottotip istoloġiku, u l-preżenza jew l-assenza ta' metastasi fl-għadam.
English: Nexavar might affect the way your wounds heal.
Maltese: Nexavar jista' jaffettwa il-mod kif ifiequ l-feriti.
English: When dose reduction is necessary during the treatment of differentiated thyroid carcinoma (DTC), the Nexavar dose should be reduced to 600 mg sorafenib daily in divided doses (two tablets of 200 mg and one tablet of 200 mg twelve hours apart).
Maltese: Meta jkun meħtieġ tnaqqis fid-doża matul il-kura ta' karċinoma differenzjata tat-tirojde (DTCdifferentiated thyroid carcinoma), id-doża ta' Nexavar għandha titnaqqas għal 600 mg sorafenib kuljum f'dożi diviżi (żewġ pilloli ta' 200 mg u pillola waħda ta' 200 mg b'intervall ta' tnax-il siegħa bejniethom).
English: CTCAE grade 3 hypocalcaemia occurred in 6.8% of sorafenib treated patients and 1.9% of patients in the placebo group, and CTCAE grade 4 hypocalcaemia occurred in 3.4% of sorafenib treated patients and 1.0% of patients in the placebo group.
Maltese: Ipokalċemija ta' CTCAE grad 3 seħħet f'6.8% tal-pazjenti kkurati b'sorafenib u f'1.9% tal-pazjenti fil-grupp talplaċebo, u ipokalċemija ta' CTCAE grad 4 seħħet fi 3.4% tal-pazjenti kkurati b'sorafenib u f'1.0% tal pazjenti fil-grupp tal-plaċebo.
English: Eight metabolites of sorafenib have been identified, of which five have been detected in plasma.
Maltese: Ġew identifikati tmin metaboliti ta' sorafenib, li ħamsa minnhom kienu osservatifil-plażma.
English: Nexavar may lead to a higher risk of bleeding.
Maltese: Dan il-prodott mediċinali jista' jkollu riskju potenzjali għall-ambjent.
English: may affect up to 1 in 100 people - inflamed stomach lining (gastritis) - pain in the tummy (abdomen) caused by pancreatitis, inflammation of the gall bladder and/or bile ducts - yellow skin or eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinaemia) - allergic like reactions (including skin reactions and hives) - dehydration - enlarged breasts (gynaecomastia) - breathing difficulty (lung disease) - eczema - overactive thyroid gland (hyperthyroidism) - multiple skin eruptions (erythema multiforme) - abnormally high blood pressure - holes in the gut wall (gastrointestinal perforation) - reversible swelling in the rear part of the brain that can be associated with headache, altered consciousness, fits and visual symptoms including visual loss (reversible posterior leukoencephalopathy) - a sudden, severe allergic reaction (anaphylactic reaction)
Maltese: Informazzjoni addizzjonali dwar popolazzjonijiet speċjali Fil-provi kliniċi, ċerti reazzjonijiet avversi tal-mediċina bħal reazzjoni tal-ġilda tal-id u s-sieq, dijarea, alopeċja, tnaqqis fil-piż, pressjoni għolja, ipokalċemija, u keratoakantoma/karċinoma taċ-ċelluli skwamużi tal-ġilda seħħew bi frekwenza li kienet ogħla b'mod sostanzjali f'pazjenti b'karċinoma differenzjata tat-tirojde meta mqabbla ma' pazjenti fl-istudji dwar karċinoma taċ-ċelluli tal-kliewi jew tal-fwied.
English: - Keep this leaflet.
Maltese: - Jekk għandek id-dijabete.
English: Red, round, biconvex film-coated tablets, debossed with Bayer cross on one side and "200" on the other side.
Maltese: Pilloli miksija b'rita, ħomor, tondi, ibbuzzati fuq iż-żewġ naħat, imnaqqxa bis-salib ta' Bayer fuq naħa u "200" fuq in-naħa l-oħra.
English: EU/1/06/342/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/342/001
English: Therefore, clinical pharmacokinetic interactions of sorafenib with substrates of these enzymes are unlikely.
Maltese: Għalhekk, interazzjonijiet farmakokinetiċi kliniċi ta' sorafenib ma' substrati ta' dawn l-isożimi mhumiex probabbli.
English: CTCAE Grade 3 or 4 amylase elevations were reported in 1 % and 2 % of patients in the sorafenib group in study 1 and study 3, respectively, compared to 3 % of patients in each placebo group.
Maltese: Elevazzjonijiet ta' amylase CTCAE ta' Grad 3 jew 4 ġew irrappurtati f'1 % u f'2 % tal-pazjenti filgrupp b'sorafenib fi studju 1 u studju 3 rispettivament, meta mqabbla ma' 3 % tal-pazjenti f'kull grupp plaċebo.
English: Results from animal studies further indicate that sorafenib can impair male and female fertility (see section 5.3).
Maltese: Fertilità Riżultati minn studji fuq l-annimali komplew jindikaw li sorafenib jista' jtellef il-fertilità fl-irġiel u fin-nisa (ara sezzjoni 5.3).
English: Drug-drug interactions
Maltese: TAL-PRODOTT MEDIĊINALI
English: Efficacy Parameter
Maltese: Parametru ta'
English: Race
Maltese: Rażża
English: Pregnancy
Maltese: - depressjoni
English: These data indicate no need for dose adjustments when paclitaxel and carboplatin are co-administered with sorafenib with a 3-day break in sorafenib dosing (two days prior to and on the day of paclitaxel/carboplatin administration).
Maltese: Din id-data tindika li m'hemmx bżonn ta' aġġustamenti fid-doża meta paclitaxel u carboplatin jingħataw flimkien ma' sorafenib b'waqfien ta' 3 ijiem fid-dożaġġ ta' sorafenib (jumejn qabel u filġurnata tal-għoti ta' paclitaxel/carboplatin).
English: Байер България ЕООД Тел.
Maltese: UAB Bayer Tel.
English: Information about excipients
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: When dose reduction is necessary during the treatment of hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC), the Nexavar dose should be reduced to two tablets of 200 mg sorafenib once daily (see section 4.4).
Maltese: Meta jkun hemm bżonn ta' tnaqqis fid-doża, matul il-kura ta' karċinoma epatoċellulari (HCChepatocellular carcinoma) u karċinoma avanzata taċ-ċelluli tal-kliewi (RCC - renal cell carcinoma), id-doża ta' Nexavar għandha titnaqqas għal żewġ pilloli ta' 200 mg sorafenib kuljum (ara sezzjoni 4.4).
English: Patients with stable disease on therapy with sorafenib were randomised to placebo or continued sorafenib therapy.
Maltese: Pazjenti b'marda stabbli fuq terapija b'sorafenib kienu randomised għall-plaċebo jew komplew it terapija b'sorafenib.
English: Other inducers of CYP3A4 activity and/or glucuronidation (e.g. Hypericum perforatum also known as St. John's wort, phenytoin, carbamazepine, phenobarbital, and dexamethasone) may also increase metabolism of sorafenib and thus decrease sorafenib concentrations.
Maltese: Indutturi oħra ta' l-attività ta' CYP3A4 u/jew glukuronidazzjoni (e.ż. Hypericum perforatum magħruf ukoll bħala St.
English: Hepatobiliary disorders increase in bilirubin and jaundice, cholecystitis, cholangitis drug induced hepatitis*
Maltese: - Doxorubicin, capecitabine, docetaxel, paclitaxel u irinotecan, li huma kura kontra l-kanċer
English: It is available in strengths from 2,000 IU/ml to 20,000 IU/ml.
Maltese: Huwa jiġi f' qawwiet li jvarjaw minn 2,000 IU/ml sa 20,000
English: The marketing authorisation was renewed on 18 March 2007.
Maltese: Lawtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit-18 ta' Marzu 2007.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Dynepo to Shire Pharmaceutical Contracts Ltd on 18 March 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha, għal Dynepo lil Shire Pharmaceutical Contracts Ltd nhar it-18 ta' Marzu 2000.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) DYNEPO EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEA (EPAR) DYNEPO
English: Dynepo contains the active ingredient epoetin delta.
Maltese: IU/ml. Dynepo fih is-sustanza attiva epoetin delta.
English: The effectiveness of Dynepo to treat anaemia has been studied in a total of 1308 patients with chronic renal failure, including two main clinical studies.
Maltese: L-effettività ta' Dynepo biex jittratta anemija ġiet studjata fuq total ta' 1308 pażjenti bi problemi kroniċi fil-kliewi, inklużi żewġ studji kliniċi prinċipali.
English: This summary was last updated in 03-2007.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'03-2007.
English: What is the risk associated with Dynepo?
Maltese: X'inhu r-riskju assoċjat ma' Dynepo?
English: In one of these, Dynepo given intravenously was compared with epoetin alfa (a similar type of drug).
Maltese: F'wieħed minn dawn, Dynepo mogħti ġol-vina tqabbel ma' epoetin alfa (mediċina simili).
English: The most common side effects are hypertension (raised blood pressure), headache, and, for patients on dialysis, problems with the dialysis tubes.
Maltese: L-aktar effetti sekondarji komuni huma pressjoni għolja, uġigħ ta' ras, u, għal pazjenti fuq dijaliżi, problemi bit-tubi tad-dijaliżi.
English: Dynepo was as effective as epoetin alfa at increasing haemoglobin levels in patients.
Maltese: Dynepo kien effettiv daqs epoetin alfa biex iżid il-livelli ta' emoglobina fil-pazjenti.
English: Epoetin delta, the active ingredient of Dynepo, is a copy of the human hormone, produced by a method known as ‘genetic engineering': the enzyme is made by a cell in which the gene (the code) for the enzyme is activated so that the cell makes more of the enzyme and it can then be extracted and used in Dynepo.
Maltese: Ormon imsejjaħ erythropoietin jistimula l-produzzjoni ta' ċelloli ħomor tad-demm mill-mudullun, Epoetin delta, is-sustanza attiva ta' Dynepo, hija kopja ta' l-ormon uman, magħmula permezz ta' metodu magħruf bħala ‘inġinerija ġenetika': l-enżima hija magħmula minn ċellola, li fiha, il-ġene (ilkodiċi) għall-enzima huwa attivat sabiex iċ-ċellola tipproduċi aktar minn din l-enżima biex umbagħad tkun tista' tiġi estratta u wżata f'Dynepo.
English: How does Dynepo work?
Maltese: X'benefiċċju wera Dynepo waqt l-istudji?
English: The Committee for Medicinal products for Human Use (CHMP) decided that Dynepo's benefits are greater than its risks for the treatment of anaemia in patients with chronic renal failure.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Dynepo għat-trattament ta' anemija f'pazjenti bi problemi kroniċi fil-kliewi huma akbar mir-riskji tiegħu.
English: Dynepo is used to treat anaemia (fewer than normal red blood cells in the blood) in adult patients with chronic renal failure (long-term kidney disease).
Maltese: Dynepo jintuża biex jittratta l-anemija (anqas ċelloli ħomor fid-demm minn normal) f'pazjenti adulti li jbagħtu minn problema kronika fil-kliewi (mard tal-kliewi mifruxa fuq tul ta' żmien).
English: Dynepo works by stimulating production of red blood cells in the same way as erythropoietin.
Maltese: Dynepo jaħdem billi jistimula l-produzzjoni ta' ċelloli ħomor tad-demm bl-istess mod bħal erythropoietin.
English: For the full description of the side effects reported with Dynepo, please see the Package Leaflet.
Maltese: Għal deskrizzjoni sħiħa ta' l-effetti sekondarji kollha rrapportati b'Dynepo, jekk jogħġbok ara l-Fuljett ta' Tagħrif mehmuż mal-pakkett.
English: Dynepo can be given intravenously (injection into a vein) or subcutaneously (injection under the skin).
Maltese: Dynepo jista' jingħata ġol-vina (injezzjoni ġol-vina) jew taħt il-ġilda (injezzjoni taħt il-ġilda).
English: In the other study, three different dosing schedules of subcutaneous Dynepo were compared.
Maltese: Fl-istudju l-ieħor, tqabblu tliet skedi ta' dożi differenti ta' Dynepo mogħti taħt il-ġilda.
English: Dynepo is a solution for injection in pre-filled syringe.
Maltese: Dynepo huwa soluzzjoni għall-injezzjoni ġo siringa mimlija bil-lest.
English: Parameter GM (% CV)
Maltese: Parametru GM (% CV)
English: EU/1/18/1332/001 EU/1/18/1332/002
Maltese: EU/1/18/1332/002
English: Expected: ↔ rosuvastatin ↔ simvastatin
Maltese: ↔ rosuvastatin ↔ simvastatin
English: Expected: ↔ lisinopril
Maltese: Mistenni: ↔ lisinopril
English: EU/1/18/1332/001 EU/1/18/1332/002 90 (3 x 30) tablets
Maltese: EU/1/18/1332/002 90 (3 x 30) pilloli
English: Do not take Pifeltro:
Maltese: Tiħux Pifeltro:
English: Opioid Analgesics methadone
Maltese: Analġeżiċi Opiojdi methadone
English: Expected:  doravirine sofosbuvir
Maltese: ↔ doravirine sofosbuvir
English: Expected: ↔ doravirine ↔ abacavir
Maltese: ↔ doravirine ↔ abacavir
English: Expected: ↔ doravirine ombitasvir/ paritaprevir/ritonavir and dasabuvir+/-ritonavir
Maltese: ↔ doravirine ombitasvir/ paritaprevir/ritonavir u dasabuvir+/-ritonavir
English: *NRTIs in DOR arm: FTC/TDF (333) or ABC/3TC (50); NRTIs in DRV+r arm: FTC/TDF (335) or ABC/3TC (48) **Subjects received FTC/TDF
Maltese: *NRTIs fil-fergħa ta' DOR: FTC/TDF (333) jew ABC/3TC (50); NRTIs fil-fergħa ta' DRV+r: FTC/TDF (335) jew ABC/3TC (48) **Individwi rċevew FTC/TDF
English: Expected: ↔ doravirine ↔ enfuviritide maraviroc
Maltese: ↔ doravirine ↔ enfuviritide maraviroc
English: Expected:  doravirine glecaprevir, pibrentasvir
Maltese: ↔ doravirine glecaprevir, pibrentasvir
English: Pifeltro contains the active substance doravirine - a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Maltese: Pifeltro fih is-sustanza attiva doravirine - inibitur mhux nucleoside ta' reverse transcriptase (NNRTI, non-nucleoside reverse transcriptase inhibitor).
English: • The active substance is doravirine 100 mg.
Maltese: • Is-sustanza attiva hi doravirine 100 mg.
English: Other established NNRTI substitutions yielded a fold change of 5-10 (G190S (5.7), K103N/P225H (7.9), V108I/Y181C (6.9), Y181V (5.1)).
Maltese: Sostituzzjonijiet stabbiliti oħra ta' NNRTI taw bidla ta' 5-10 darbiet (G190S (5.7); K103N/P225H (7.9), V108I/Y181C (6.9), Y181V (5.1)).
English: †- boosted PIs (atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, saquinavir, tipranavir)
Maltese: PIs imsaħħa b'ritonavir† (atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, saquinavir, tipranavir)
English: Interactions table
Maltese: Tabella ta' interazzjonijiet
English: Effects of other medicinal products on doravirine
Maltese: Effetti ta' prodotti mediċinali oħra fuq doravirine
English: Expected: ↔ doravirine ↔ emtricitabine tenofovir alafenamide
Maltese: ↔ doravirine ↔ emtricitabine tenofovir alafenamide