FrancophonIA/ELRC3.0 huggingface dataset:
English: On 14 March 2012, Astellas Pharma Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Qutenza, which would have extended its use to patients with diabetes who have peripheral neuropathic pain not caused by their diabetes.
Maltese: Fl-14 ta' Marzu 2012, Astellas Pharma Europe B.V. għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għal tibdil flawtorizzazzjoni għat-tqegħid fis-suq għal Qutenza, li kien jestendi l-użu tiegħu lil pazjenti bid-dijabete li jbatu minn uġigħ newropatiku periferiku li ma jkunx ikkawżat mid-dijabete tagħhom.
English: Qutenza has been authorised in the EU since May 2009 and is already used to treat peripheral neuropathic pain (pain that is caused by damage to the nerves in the extremities) in adults who do not have diabetes.
Maltese: Qutenza ilu awtorizzat fl-UE minn Mejju 2009 u diġà jintuża għall-kura ta' uġigħ newropatiku periferiku (uġigħ ikkawżat minn ħsara fin-nervituri fl-estremitajiet) f'adulti li ma jkunux morda bid-dijabete.
English: Qutenza is a cutaneous patch (a patch that delivers a medicine to the skin).
Maltese: Qutenza huwa stikk kuntanju (dan ifisser li l-mediċina tingħata minn ġol-ġilda).
English: This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Maltese: Dan ifisser li s-CHMP kien evalwa d-dokumentazzjoni pprovduta mill-kumpanija u fformula lista ta' mistoqsijiet.
English: What was Qutenza expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Qutenza?
English: This means that it stimulates the TRPV1 receptor, which is found in the nociceptors (pain receptors) in the skin.
Maltese: Dan ifisser li din tistimula r-riċettur TRPV1, li jinstab fin-noċiċetturi (riċetturi tal-uġigħ) fil-ġilda.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Qutenza could not have been approved to treat diabetic patients with non-diabetic peripheral neuropathic pain.
Maltese: Abbażi tal-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, is-CHMP kellu xi tħassib u opinjoni proviżorja li Qutenza ma setax jiġi approvat għall-kura ta' pazjenti dijabetiċi li jbatu minn uġigħ newropatiku periferiku mhux dijabetiku.
English: Overstimulating the receptors makes them become ‘desensitised' and no longer able to respond to the stimuli that normally cause pain in patients with peripheral neuropathic pain.
Maltese: L-istimulazzjoni eċċessiva tar-riċetturi tneħħilhom issensittività u ma jibqgħux ikunu kapaċi jirrispondu għall-istimuli li normalment jikkawżaw l-uġigħ filpazjenti li jbatu mill-uġigħ newropatiku periferiku.
English: Patients with diabetes, but especially those with diabetic neuropathic pain, could be put at risk as Qutenza may increase their chances of developing ulcers in the foot, which could lead to serious complications.
Maltese: Pazjenti morda bid-dijabete, iżda speċjalment dawk li jbatu minn uġigħ newropatiku dijabetiku, ma setgħux jitpoġġew f'riskju peress li Qutenza jista' jżid il-possibbiltajiet tagħhom li jiżviluppaw ulċeri fis-sieq, li jista' jwassal għal kumplikazzjonijiet serji.
English: Expected: ↓ esomeprazole, lansoprazole
Maltese: Mistenni: ↓ esomeprazole, lansoprazole
English: See section 5.1 for additional information.
Maltese: Ara sezzjoni 5.1 għal informazzjoni addizzjonali.
English: AbbVie Ltd Maidenhead SL6 4UB United Kingdom
Maltese: AbbVie Ltd Maidenhead SL6 4UB
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/982/001
Maltese: EU/1/14/982/001
English: ↑ lovastatin, simvastatin, atorvastatin
Maltese: Mistenni: ↑ lovastatin, simvastatin, atorvastatin
English: HIV ANTIVIRALS: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Rilpivirine2
Maltese: INIBITURI NON-NUCLEOSIDE REVERSE TRANSCRIPTASE Rilpivirine
English: 60 patients were randomized and treated, and 60/60 (100%) achieved SVR12.
Maltese: 60 pazjent kienu randomizzati u trattati, u 60/60 (100%) kisbu SVR12.
English: PEARL I was conducted in the US and Europe, M12536 in Japan.
Maltese: PEARL I kien sar fl-Istati Uniti u l-Ewropa, M12536 fil-Ġappun.
English: Polyvinyl alcohol (E1203) Polyethylene glycol 3350 Talc (E553b) Titanium dioxide (E171) Iron oxide red (E172)
Maltese: Kisja tal-pillola Polyvinyl alcohol (E1203) Polyethylene glycol 3350 Talc (E553b) Titanium dioxide (E171) Iron oxide red (E172)
English: ANTI-GOUT Colchicine
Maltese: ANTI-GOTTA Colchicine
English: Expected: ↑ ticagrelor
Maltese: Mistenni: ↑ ticagrelor
English: Manufacturer
Maltese: Prodotti
English: ALPHA 1-ADRENORECEPTOR ANTAGONIST Alfuzosin
Maltese: ANTAGONIST TAL-ALPHA 1-ADRENORECEPTER
English: Number of Responders at the End of Treatment AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment
Maltese: AFP* < 20 ng/mL, plejtlits ≥ 90 x 109/L, U albumina ≥ 35 g/L qabel it-trattament
English: − Tablet core: copovidone, vitamin E polyethylene glycol succinate, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E551), sodium stearyl fumarate.
Maltese: − Qalba tal-pillola: copovidone, vitamina E polyethylene glycol succinate, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E551), sodium stearyl fumarate.
English: 4-24 mg/16 mg once daily
Maltese: 4-24 mg/ 1-6 mg darba
English: Duloxetine 60 mg single dose
Maltese: Duloxetine 60 mg doża waħda
English: INFORMATION IN BRAILLE viekirax
Maltese: INFORMAZZJONI BIL-BRAILLE viekirax
English: TURQUOISE III (open-label)
Maltese: TURQUOISE III (tikketta miftuħa)
English: Simvastatin, lovastatin and atorvastatin are contraindicated (see section 4.3 and 4.5).
Maltese: Simvastatin, lovastatin u atorvastatin huma kontraindikati (ara sezzjoni 4.3 u 4.5).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 15 Jannar 2015
English: The magnitude of interaction when administered with medicinal products listed in Table 2 are similar
Maltese: Id-daqs tal-interazzjoni meta jingħata ma' prodotti mediċinali elenkati fit-Tabella 2 huma simili
English: − Tablet film-coating: polyvinyl alcohol (E1203), polyethylene glycol 3350, talc (E553b), titanium dioxide (E171) and red iron oxide (E172).
Maltese: − Kisja tar-rita tal-pillola: polyvinyl alcohol (E1203) , polyethylene glycol 3350, talc, (E553b),titanium dioxide (E171) u red iron oxide (E172)
English: Patients with severe hepatic impairment (Child-Pugh C) (see section 5.2).
Maltese: Pazjenti b'indeboliment epatiku sever (Child-Pugh C) (ara sezzjoni 5.2).
English: Viekirax and dasabuvir + ribavirin 12 or 24 weeks N = 380 n (%)
Maltese: Viekirax u dasabuvir + ribavirin 12 jew 24 ġimgħa N = 380 n (%)
English: 33 out of the 34 subjects (97.1%) achieved SVR12 (96.6% in subjects with genotype 1a infection and 100% in subjects with genotype 1b infection).
Maltese: 33 mill-34 individwi (97.1%) kisbu SVR12 (96.6% f'individwi b'infezzjoni tal-ġenotip 1a u 100% f'individwi b'infezzjoni tal-ġenotip 1b).
English: Ethinylestradiol is contraindicated in combination with Viekirax (see sections 4.3 and 4.4).
Maltese: Ethinylestradiol huwa kontraindikat f'kombinazzjoni ma' Viekirax (ara sezzjoni 4.3 u 4.4).
English: ANTIPSYCHOTICS Lurasidone
Maltese: ANTIPSIKOTIĊI Lurasidone Pimozide
English: Viekirax dasabuvir hydrocodone
Maltese: Viekirax + dasabuvir hydrocodon e
English: SVR12, n/N (%) [95% CI] Outcome for subjects without SVR12 On-treatment virologic failure Post-treatment relapse
Maltese: SVR12, n/N (%) [95% CI] Riżultati għall-individwi mingħajr SVR12
English: Medicinal products that inhibit CYP3A4 and transport proteins Paritaprevir is eliminated via CYP3A4 mediated metabolism and biliary excretion (substrate of the hepatic transporters OATP1B1, P-gp and BCRP).
Maltese: Prodotti mediċinali li jinibixxu CYP3A4 u proteini tat-trasport Paritaprevir jiġi eliminat permezz ta' metaboliżmu medjat ta' CYP3A4 u eliminazzjoni biljari (substrat ta' l-trasportaturi epatiċi OATP1B1, P-gp u BCRP).
English: Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL
Maltese: HCV ≥ 25 IU/mL ikkonfermat wara RNA tal-HCV < 25 IU/mL matul il-kura, żieda ta' 1 log10 IU/mL
English: Such medicinal products include some statins (see Table 2), fexofenadine, repaglinide and angiotensin II receptor antagonists (e.g., valsartan).
Maltese: Prodotti mediċinali bħal dawn jinkludu xi statins (ara Tabella 2), fexofenadine, repaglinide u antagonisti tar riċettur tal-angiotensin II (eż. valsartan).
English: Table 19.
Maltese: Tabella 19.
English: (see sections 4.2, 4.4, and
Maltese: (ara sezzjoni 4.3).
English: Clinical trials in peginterferon+ribavirin-experienced adults
Maltese: Provi kliniċi bl-esperjenza ta' peginterferon+ribavirin f'adulti
English: CYP2D6 substrates (e.g. desipramine, metoprolol and dextromethorphan) are not expected to require dose adjustments.
Maltese: Subtrati ta' CYP2D6 (e.ż. desipramine, metoprolol u dextromethorphan) mhumiex mistennija li jeħtieġu aġġustamenti fid-doża.
English: In subjects receiving Viekirax and dasabuvir without ribavirin, adverse events typically associated to ribavirin (e.g. nausea, insomnia, anaemia) were less frequent and no subjects (0/588) permanently discontinued treatment due to adverse reactions.
Maltese: F'individwi li qed jirċievu Viekirax u dasabuvir mingħajr ribavirin, reazzjonijiet avversi tipikament assoċjati ma' ribavirin (e.ż. dardir, għejja, anemija) kienu anqas frekwenti u l-ebda individwi (0/588) ma waqqfu l-kura b'mod permanenti minħabba avvenimenti avversi.
English: Viekirax tablets are usually taken with other anti-viral medicines such as “dasabuvir” and “ribavirin”.
Maltese: Pilloli ta' Viekirax huma normalment meħudin ma' mediċini anti-virali oħra bħal "dasabuvir" u "ribavirin".
English: HCV genotype 1b
Maltese: Ġenotip 1b HCV
English: Age, median (range) years Male gender, n (%) Prior HCV Treatment: naïve, n (%) Peg-IFN + RBV, n (%) Baseline albumin, median g/L < 35, n (%)
Maltese: Eta, snin medja (firxa) Sess maskil, n (%) Qabel it-trattament ta' HCV: naïve, n (%) Peg-IFN + RBV, n (%) Linja bażi ta' albumina, medja g/L <35, n (%) >35, n (%) Linja bażi tal-għadd ta' plejtlits, medja (x109/L) 132.0 < 90, n (%) > 90, n (%)
English: Hepatitis B Virus Reactivation
Maltese: Riattivazzjoni tal-Virus tal-Epatite B
English: CYP3A substrates evaluated in drug interaction studies which may require dose adjustment and/or clinical monitoring include (see Table 2) cyclosporine, tacrolimus, amlodipine, rilpivirine and alprazolam.
Maltese: Substrati ta' CYP3A evalwati fi studji ta' interazzjoni ta' mediċina li jistgħu jeħtieġu aġġustament fiddoża u/ jew monitoraġġ kliniku jinkludu (ara Tabella 2) cyclosporine, tacrolimus, amlodipine, rilpivirine u alprazolam .
English: Drug interactions were evaluated for the Viekirax and dasabuvir regimen, but not for the Viekirax without dasabuvir, with carbamazepine, furosemide, zolpidem, darunavir twice daily, darunavir (evening administration), atazanavir (evening administration), rilpivirine, abacavir/lamivudine, dolutegravir, metformin, sulfamethoxazole/trimethoprim, cyclobenzaprine, carisoprodol, hydrocodone/ paracetamol or diazepam.
Maltese: furosemide, zolpidem, darunavir darbtejn kuljum, darunavir (għoti filgħaxija), atazanavir (għoti filgħaxija), rilpivirine, abacavir/lamivudine, dolutegravir, metformin, sulfamethoxazole/trimethoprim, cyclobenzaprine, carisoprodol, hydrocodone/ paracetamol or diazepam.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Sussegwentement, id-detentur talawtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Viekirax is not recommended in patients with moderate hepatic impairment (Child-Pugh B) (see sections 4.4 and 4.8).
Maltese: Viekirax mhux rrakkomandat f'pazjenti b'indeboliment epatiku moderat (Child-Pugh B) (ara sezzjonijiet 4.4 u 4.8).
English: Viekirax is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Maltese: Viekirax mhux rrakkomandat f'pazjenti b'indeboliment epatiku moderat (Child-Pugh B).
English: Viekirax is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.3, 4.8 and
Maltese: Viekirax m'għandux jintuża f'pazjenti b'indeboliment epatiku serju (Child-Pugh C) (ara sezzjonijiet 4.2, 4.3, 4.8 u
English: AbbVie Deutschland GmbH & Co. KG Knollstrasse,
Maltese: AbbVie Deutschland GmbH & Co.
English: 20-120 mg once daily
Maltese: 20-120mg darba kuljum5
English: These medicinal products may show clinically relevant increases in exposures of paritaprevir (e.g., ritonavir with atazanavir, erythromycin, diltiazem or verapamil).
Maltese: Dawn il-prodotti mediċinali jistgħu juru żidiet klinikament rilevanti fil-espożizzjonijiet ta' paritaprevir (eż ritonavir ma' atazanavir, erythromycin, diltiazem jew verapamil).
English: • Monitor for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage).
Maltese: • Tissorvelja għal sinjali kliniċi u sintomi ta' dikompensazzjoni epatika (bħal axxite, enċefalopatija epatika, emorraġija variceal).
English: increase in HCV RNA from nadir, or HCV RNA persistently ≥ 25 IU/mL with at least 6 weeks of treatment.
Maltese: ikkonferma f'RNA tal-RNA tal-HCV minn nadir, jew RNA tal-HCV persistentement ≥ 25 IU/mL b'talanqas kura ta' 6 ġimgħat.
English: SVR12 for HIV-1 co-infected Subjects in TURQUOISE-I
Maltese: SVR12 għal individwi bi ko-infezzjoni ta' HIV-1 fi TURQUOISE-I
English: The mean EC50 of paritaprevir against replicons containing NS3 from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.86 nM (range 0.43 to 1.87 nM; n=11) and 0.06 nM (range 0.03 to 0.09 nM; n=9), respectively.
Maltese: L-EC50 medja ta' paritaprevir meta mqabbel mar-replicons li fihom NS3 minn penil ta' iżolati tal-ġenotip 1a u 1b naïve għall-kura flanaliżi tal-kultura taċ-ċelloli ta' replicon ta' HCV kienet 0.86 nM (medda minn 0.43 sa 1.87 nM; n=11) u 0.06 nM (medda minn 0.03 sa 0.09 nM; n=9), rispettivament.
English: Results from the pharmacokinetic evaluation of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg can be extrapolated to the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg.
Maltese: Ir-riżultati mill-evalwazzjoni tal-farmokokinetika tal-kombinazzjoni ta' ombitasvir 25 mg, paritaprevir 200 mg, u ritonavir 100 mg, ma' dasubuvir 400 mg tista' tiġi estrapolata għallkombinazzjoni ta' ombitsavir 25 mg, paritaprevir 200 mg, u ritonavir 100 mg.
English: In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
Maltese: 90 x 109 / L, u albumina ≥ 35 g / L), rati ta' rikaduta kienu simili f'individwi kkurati għal 12 jew 24 ġimgħa.
English: CONTRACEPTIVES Ethinylestradiol/ norgestimate
Maltese: Ethinyl estradiol/ norgestimate mg darba kuljum
English: Follow the dosing recommendations in Table 1.
Maltese: Segwi ir-rakkomandazzjonijiet ta' dożaġġ f'Tabella 1.
English: Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AX67
Maltese: Antivirali għal użu sistemiku; antivirali b'azzjoni diretta, Kodiċi ATC:
English: Concomitant use of fluticasone can increase systemic exposures of fluticasone.
Maltese: fluticasone jista' jżid esponimenti sistemiċi ta'
English: Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Maltese: Il-valuri HCV RNA fil-plażma tkejlu matul il-provi kliniċi permezz tat-test COBAS TaqMan HCV (verżjoni 2.0), għall-użu mas-Sistema High Pure.
English: ANGIOTENSIN RECEPTOR BLOCKER Valsartan
Maltese: IMBLOKKATUR TAR-RIĊETTUR TA' ANGIOTENSIN Valsartan
English: It contains the active substances ombitasvir, paritaprevir and ritonavir.
Maltese: Fiha is-sustanzi attivi ombitasvir, paritaprevir u ritonavir.
English: Viekirax is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.3 and 5.2).
Maltese: Viekirax huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (ChildPugh C) (ara sezzjoni 4.3 u 5.2).
English: CYP2C19 substrates evaluated in drug interaction studies include omeprazole and escitalopram (see Table 2).
Maltese: interazzjoni ta' mediċina jinkludu omeprazole u escitalopram (ara Tabella 2).
English: No increase in incidence of ALT elevations was observed with other types of estrogens commonly used for hormone replacement therapy (e.g. estradiol and conjugated estrogens).
Maltese: Ebda żieda fl-inċidenza ta' elevazzjoni fl-ALT ma kienet osservata ma' tipi oħra ta ' estroġeni sistemiċi komunament użati għal terapija ta' sostituzzjoni bl-ormoni (e.ż, estradiol u estroġeni konjugat).
English: Alprazolam 0.5 mg single dose
Maltese: Alprazolam 0.5mg doża waħda Mekkaniżmu:
English: % (n)
Maltese: N=7 % (n)
English: ANTIHISTAMINES Astemizole
Maltese: AĠENTI ANTIPLEJTLITS
English: Expected:
Maltese: *Nota:
English: The EC50 of paritaprevir against genotype 1a-H77 and 1b-Con1 strains in the HCV replicon cell culture assay was 1.0 and 0.21 nM, respectively.
Maltese: L-EC50 ta' paritaprevir meta mqabbel mar-razez tal-ġenotip 1a-H77 u 1b-Con1 fl-analiżi tal-kultura taċ ċelloli ta' replicon ta' HCV kienet 1.0 u 0.21 pM, rispettivament.
English: SAPPHIRE-II - genotype 1, pegIFN+RBV-experienced, without cirrhosis
Maltese: SAPPHIRE-II - ġenotip 1, bl-esperjenza ta' pegIFN+RBV, mingħajr ċirrożi
English: Mechanism: CYP2C19 induction by ritonavir.
Maltese: induzzjoni ta' CYP2C19 minn ritonavir .
English: Viekirax 12.5 mg/75 mg/50 mg film-coated tablets ombitasvir/paritaprevir/ritonavir
Maltese: Viekirax 12.5 mg / 75 mg / 50 mg pilloli miksijin b'rita ombitasvir / paritaprevir / ritonavir
English: Atazanavir/ ritonavir
Maltese: Atazanavir/ ritonavir atazanavir
English: NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg / 75 mg / 50 mg tablets ombitasvir / paritaprevir / ritonavir
Maltese: Viekirax 12.5 mg/75 mg/50 mg pilloli miksijin b'rita ombitasvir / paritaprevir / ritonavir
English: Phase 3 global multicentre studies conducted with Viekirax and dasabuvir with or without ribavirin (RBV).
Maltese: Tabella 6 Studji multiċentriċi globali, ta' Fażi 3, imwettqa b'Viekirax u Exviera b'ribavirin jew mingħajru (RBV).
English: SVR12 for HCV Genotype 4-Infected Subjects with Compensated Cirrhosis Ombitasvir + Paritaprevir + Ritonavir with RBV 12 Weeks
Maltese: Infettati b'HCV ġenotip 4 b'Ċirrożi Kkumpensata Ombitasvir + Paritaprevir + Ritonavir b' RBV
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 56 (4 packs of 14) film-coated tablets
Maltese: Pakkett multiplu: 56 (4 pakketti ta' 14) pillola miksija b'rita
English: • Discontinue treatment in patients who develop evidence of hepatic decompensation.
Maltese: • Waqqaf it-trattament f'pazjenti li jiżviluppaw evidenza ta' dekompensazzjoni epatika.
English: Pink, oblong, biconvex, film-coated tablets of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘AV1'.
Maltese: Pilloli roża, tawwalin, bikonvessi, miksijin b'rita b'daqs ta' 18.8mm x 10.
English: In TURQUOISE-I, the SVR12 rates in HCV/HIV-1 co-infected subjects were consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
Maltese: Fi TURQUOISE-I , ir-rati ta' SVR12 f'individwi b'ko-infezzjoni ta' HCV/HIV-1 kienu konsistenti ma' rrati ta' SVR12 fil-provi kliniċi ta' fażi 3 ta' individwi mono-infettati b'HCV.
English: These medicines may be available without a prescription atorvastatin, lovastatin, simvastatin to lower blood cholesterol carbamazepine, phenytoin, phenobarbital for epilepsy cisapride for relieving certain stomach problems clarithromycin, fusidic acid, rifampicin, telithromycin for bacterial infections colchicine in patients who have severe problems with their liver or kidneys for treating gout attacks conivaptan for making the sodium levels in the blood normal efavirenz, etravirine, lopinavir/ritonavir, saquinavir, tipranavir, nevirapine, indinavir, cobicistat for HIV infection enzalutamide for prostate cancer ergotamine, dihydroergotamine for migraine headaches ergonovine, methylergometrine used in childbirth ethinylestradiol-containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception itraconozole, ketoconozole, posaconazole, voriconazole for fungal infections midazolam, triazolam (when taken by mouth) for anxiety or trouble sleeping mitotane for symptoms of malignant tumours of the adrenal glands pimozide, lurasidone for schizophrenia quetiapine for schizophrenia, bipolar disorder and major depressive disorder quinidine for abnormal heart rhythms or malaria ranolazine for chronic angina (chest pain)
Maltese: Dawn il-mediċini jistgħu jkunu disponibbli mingħajr riċetta atorvastatin, lovastatin, simvastatin biex jitnaqqas il-kolesterol fid-demm carbamazepine, phenytoin, phenobarbital għal epilessija cisapride biex itaffi ċerti problemi fl-istonku clarithromycin, fusidic acid, rifampicin, telithromycin għall-infezzjonijiet batteriċi colchicine in patients who have severe problems with their liver or kidneys għat-trattament tal-attakki tal-gotta conivaptan
English: Y93H, Y93N or M28V in combination with Q30R reduced the activity of ombitasvir by more than 42,802-fold.
Maltese: Y93H, Y93N jew M28V flimkien ma' Q30R naqqsu l-attività ta' ombitasvir b'aktar minn
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of multipack containing 56 (4 packs of 14) film-coated tablets - including blue box
Maltese: Kartuna ta' barra ta' pakkett multiplu li fih 56 (4 pakketti ta 14-il) pillola miksijin b'rita - inkluż kaxxa blu
English: Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or raltegravir, coadministered with a backbone of tenofovir plus emtricitabine or lamivudine.
Maltese: Individwi li kienu fuq kors ta' terapija antiretrovirali (ART) HIV-1 li kienu inklużi ritonavir imsaħħaħ b'atazanavir jew raltegravir, amministrati fl-istess ħin b'sinsla ta' tenofovir + emtricitabine jew lamivudine.
English: PEARL-IV - genotype 1a, treatment-naïve, without cirrhosis
Maltese: PEARL-IV - ġenotip 1a, naïve għall-kura, mingħajr ċirrożi Disinn:
English: CYP3A4 inhibition by protease inhibitors.
Maltese: inibizzjoni ta' CYP3A4 minn inibituri tal-protease
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, female subjects would have approximately 55% higher, 100% higher and 15% higher ombitasvir, paritaprevir and ritonavir exposures than male subjects.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni ta' dejta minn studji kliniċi Fażi 3, individwi nisa jkollhom jkollhom espożizzjonijiet ta' madwar 55% ogħla, 100% ogħla u 15% ogħla ta'ombitasvir,
English: CORAL-I: treatment-naïve or pegIFN + RBV-experienced, at least 12 months post liver transplant
Maltese: CORAL-I: naïve għall-kura jew bl-esperjenza ta' pegIFN+RBV, mill-inqas 12-il xahar wara t-trapjant tal-fwied
English: PEARL-III - genotype 1b, treatment-naïve, without cirrhosis Design:
Maltese: PEARL-III - ġenotip 1b, naïve għall-kura, mingħajr ċirrożi Disinn: