FrancophonIA/ELRC3.0 huggingface dataset:
English: The duration of immunity after the last re-vaccination is 3 years for rhinotracheitis, calicivirosis and panleucopenia components.
Maltese: L-immunità wara l-aħħar tilqima tibqa 3 snin għall-komponenti tar-rinotrakeite, kaliċivirosi, u panlewkopenja.
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia.
Maltese: - kontra l-panlewkopenja fil-qtates biex tipprevjeni l-mortalità u sinjali kliniċi
English: Nyxoid is a ‘hybrid medicine'.
Maltese: Nyxoid huwa “mediċina ibrida”.
English: The full EPAR for Nyxoid 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: Nyxoid is a nasal spray available in single-dose containers (1.8 mg).
Maltese: Nyxoid huwa sprej għall-imnieħer li jiġi f'kontenituri ta' doża unika (1.8 mg).
English: It contains the active substance naloxone.
Maltese: Fih is-sustanza attiva naloxone.
English: Nyxoid can be used in adults and adolescents from 14 years of age.
Maltese: Nyxoid jista' jintuża fuq adulti u adolexxenti ta' aktar minn 14-il sena.
English: This is a summary of the European public assessment report (EPAR) for Nyxoid.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Nyxoid.
English: In addition, a study involving 38 healthy volunteers showed that, when given by a healthcare professional, Nyxoid 2 mg given as a spray into the nose produced a similar level of naloxone in the body as naloxone given in the usual dose of 0.4 mg by injection into a muscle.
Maltese: Barra minn hekk, studju li fih ħadu sehem 38 voluntier b'saħħithom wera li, meta mogħti minn professjonista fil-qasam tal-kura tas-saħħa, Nyxoid 2 mg mogħti bħala sprej fl-imnieħer ipproduċa livell simili ta' naloxone filġisem bħal naloxone mogħti fid-doża tas-soltu ta' 0.4 mg permezz ta' injezzjoni ġo muskolu.
English: The active substance in Nyxoid, naloxone, counteracts the effects of opioid drugs.
Maltese: Is-sustanza attiva f'Nyxoid, naloxone, taħdem kontra l-effetti ta' drogi opjojdi.
English: Why is Nyxoid approved?
Maltese: Għalxiex ġie approvat Nyxoid?
English: Other information about Nyxoid
Maltese: Informazzjoni oħra dwar Nyxoid
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but is given in a different way.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' li fiha l-istess sustanza attiva, iżda tingħata b'mod differenti.
English: While the reference medicine Naloxon HCl B. Braun is given by injection, Nyxoid is given as a spray into the nose.
Maltese: Filwaqt li l-mediċina ta' referenza Naloxon HCl B.
English: What are the risks associated with Nyxoid?
Maltese: X'inhuma r-riskji assoċjati ma' Nyxoid?
English: Typical opioid withdrawal syndrome is expected after Nyxoid is given to people addicted to opioids; symptoms include restlessness, agitation, feeling or being sick, a fast heart rate and sweating.
Maltese: Wara l-għoti ta' Nyxoid lil persuni dipendenti fuq l-opjojdi wieħed jista' jistenna s-sindrome tipiku tal-irtirar tal-opjojdi; is-sintomi jinkludu irrekwitezza, aġitazzjoni, dardir jew rimettar, rata talqalb mgħaġġla u għeriq.
English: Nyxoid is a medicine used for emergency treatment in case of known or suspected overdose of opioid drugs (such as heroin or morphine).
Maltese: Nyxoid huwa mediċina li tintuża għal kura ta' emerġenza f'każ ta' doża eċċessiva magħrufa jew suspettata ta' mediċini opjojdi (bħall-eroina jew il-morfina).
English: Signs of overdose include pinpoint pupils, abnormally slow and irregular breathing, severe sleepiness and unresponsiveness to touch or loud noises.
Maltese: Sinjali ta' doża eċċessiva jinkludu pupilli tal-għajnejn żgħar ħafna, teħid tan-nifs abnormalment bilmod u irregolari, ngħas sever u nuqqas ta' rispons għal mess jew ħsejjes qawwija.
English: The company provided data from the published literature showing that naloxone is effective in treating opioid overdose when given by injection (the standard treatment for opioid overdose) as well as into the nose.
Maltese: Il-kumpanija pprovdiet data mil-letteratura ppubblikata li turi li naloxone huwa effettiv fil-kura ta' doża eċċessiva ta' opjojdi meta jingħata b'injezzjoni (il-kura standard għal doża eċċessiva ta' opjojdi) kif ukoll fl-imnieħer.
English: The company that markets Nyxoid will issue educational materials, including a video, for healthcare professionals and for patients with detailed information on how to use the medicine.
Maltese: Il-kumpanija li tqiegħed Nyxoid fis-suq sejra tippubblika materjal edukattiv, inkluż vidjow, għallprofessjonisti fil-qasam tal-kura tas-saħħa u għall-pazjenti b'informazzjoni dettaljata dwar il-mod kif tintuża l-mediċina.
English: The recommended dose is one spray into one nostril given immediately on suspecting an opioid overdose and while awaiting emergency services; if the first dose does not have an effect, a second dose should be given after 2-3 minutes in the other nostril.
Maltese: Id-doża rrakkomandata hija ta' sprejjatura waħda f'minfes wieħed li tingħata immedjatament f'każ ta' suspett ta' doża eċċessiva ta' opjojdi u sakemm wieħed ikun qiegħed jistenna li jaslu s-servizzi ta' emerġenza; jekk lewwel doża ma jkollhiex effett, wara 2-3 minuti għandha tingħata t-tieni doża fil-minfes l-ieħor.
English: For the full list of all side effects and restrictions with Nyxoid, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati b'Nyxoid, ara l-fuljett ta' tagħrif.
English: Naloxone, the active substance in Nyxoid, has been widely used in emergency medicine since the 1970s to treat opioid overdose.
Maltese: Naloxone, is-sustanza attiva f'Nyoxid, ilu jintuża b'mod wiesgħa fil-mediċina ta' emerġenza missebgħinijiet għall-kura ta' doża eċċessiva ta' opjojdi.
English: The most common side effect with Nyxoid (which may affect more than 1 in 10 people) is nausea (feeling sick).
Maltese: L-effett sekondarju l-aktar komuni b'Nyxoid (li jista' jaffettwa aktar minn 1 minn kull 10) huwa nawżja (dardir).
English: The safety and effectiveness of naloxone as an antidote for opioid overdose are well known.
Maltese: Is-sigurtà u l-effikaċja ta' naloxone bħala antidotu għal doża eċċessiva ta' opjojdi huma magħrufa sew.
English: How is Nyxoid used?
Maltese: Kif jaħdem Nyxoid?
English: EMA/596398/2014 EMEA/H/C/002810
Maltese: EMEA/H/C/002810
English: Moventig naloxegol
Maltese: Moventig naloksegol
English: The full EPAR and risk management plan summary for Moventig 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: Moventig is available as tablets (12.5 and 25 mg).
Maltese: Moventig jiġi bħala pilloli (12.5 u 25 mg).
English: The active substance in Moventig, naloxegol, is a peripheral mu-opioid-receptor antagonist.
Maltese: Is-sustanza attiva f'Moventig, in-naloksegol, hija antagonista tar-riċettur mu-opjojdi periferali.
English: When looking at the results of both main studies together, 48% (115 out of 241) of adults who previously had an inadequate response to laxatives and who took 25 mg Moventig responded to treatment compared with 30% (72 out of 239) of adults on placebo.
Maltese: Meta wieħed iħares lejn irriżultati taż-żewġ studji ewlenin, 48% (115 minn 241) tal-adulti li qabel kellhom rispons inadegwat għal-lassattivi u li ħadu 25 mg ta' Moventig irrispondew għall-kura meta mqabbla ma' 30% (72 minn 239) tal-adulti fuq plaċebo.
English: For adults who took 12.5 mg Moventig and who previously had an inadequate response to laxatives, 43% (102 out of 240) responded to treatment.
Maltese: Għall-adulti li ħadu 12.5 mg ta' Moventig u li qabel kellhom rispons inadegwat għal-lassattivi, 43% (102 minn 240) irrispondew għall-kura.
English: Moventig contains the active substance naloxegol.
Maltese: Moventig fih is-sustanza attiva naloksegol.
English: Other information about Moventig
Maltese: Informazzjoni oħra dwar Moventig
English: In terms of safety, the side effects were considered acceptable or manageable.
Maltese: F'termini ta' sigurtà, l-effetti sekondarji tqiesu aċċettabbli jew maniġġevoli.
English: This is a summary of the European public assessment report (EPAR) for Moventig.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Moventig.
English: The recommended dose is one 25 mg tablet a day.
Maltese: Id-doża rakkomandata hija ta' pillola waħda ta' 25 mg kuljum.
English: What are the risks associated with Moventig?
Maltese: X'inhuma r-riskji assoċjati ma' Moventig?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Moventig on 8 December 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Moventig fit-8 ta' Diċembru 2014.
English: Why is Moventig approved?
Maltese: Għaliex ġie approvat Moventig?
English: The most common side effects with Moventig (which may affect more than 5 in 100 people) are abdominal pain (stomach ache), diarrhoea, nausea (feeling sick), headache and flatulence (passing wind).
Maltese: L-effetti sekondarji l-aktar komuni b'Moventig (li jistgħu jaffettwaw aktar minn 5 persuni minn kull 100) huma uġigħ addominali (uġigħ fl-istonku), dijarea, nawżja (dardir), uġigħ ta' ras u gass fl-istonku (tgħaddi l-gass).
English: People either received Moventig (at 12.5 and 25 mg) or placebo (a dummy treatment) for 12 weeks.
Maltese: Il-persuni jew irċevew Moventig (f'12.5 u 25 mg) jew plaċebo (kura finta) għal 12-il ġimgħa.
English: How is Moventig used?
Maltese: Kif jaħdem Moventig?
English: A risk management plan has been developed to ensure that Moventig is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Moventig jintuża bl-aktar mod sigur possibbli.
English: A lower starting dose of 12.5 mg may be prescribed in patients with moderately or severely reduced kidney function or who are taking certain other medicines that increase the effects of Moventig.
Maltese: Pazjenti bi tnaqqis moderat jew sever fil-funzjoni tal-kliewi jew li jkunu qed jieħdu ċerti mediċini oħra li jżidu l-effetti ta' Moventig jistgħu jinbdew fuq doża aktar baxxa ta' 12.5 mg.
English: Moventig must not be used in patients who have or who are at high risk of bowel obstruction (blockage in the gut) or in patients with cancer who are at a high risk of gastro-intestinal perforation (a hole that develops in the wall of the gut).
Maltese: Moventig m'għandux jintuża f'pazjenti li għandhom jew li qegħdin f'riskju għoli ta' ostruzzjoni fl-imsaren (imblukkar fl-imsaren) jew f'pazjenti b'kanċer li qegħdin f'riskju għoli ta' perforazzjoni gastro-intestinali (toqba li tiżviluppa fil-ħajt tal-imsaren).
English: The studies involved 1,352 adults with constipation caused by opioids that were being used to treat non-cancer pain, half of whom had an inadequate response to laxatives (720).
Maltese: Fl-istudji ħadu sehem 1,352 adult bi stitikezza kkawżata mill-opjojdi li kienu qed jintużaw għall-kura ta' uġigħ li ma kienx ġej mill-kanċer, li nofshom kellhom rispons inadegwat għal-lassattivi (720).
English: The CHMP considered that Moventig had shown a clinically relevant benefit when used in adults who have not responded adequately to previous treatment with laxatives.
Maltese: Is-CHMP qies li Moventig wera benefiċċju klinikament rilevanti meta ntuża f'adulti li ma rrispondewx b'mod adegwat għal kura preċedenti bil-lassattivi.
English: Naloxegol is derived from naloxone, a well-known substance that is used to block the action of opioids.
Maltese: In-naloksegol tiġi derivata min-nalokson, sustanza magħrufa sew li tintuża biex timblokka l-azzjoni tal-opjojdi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Moventig's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Moventig huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Moventig has been shown to be effective at treating constipation in adults who had an inadequate response to laxatives in two main studies.
Maltese: Moventig intwera li kien effettiv fil-kura tal-istitikezza fl-adulti li kellhom rispons inadegwat għallassattivi f'żewġ studji ewlenin.
English: Moventig is a medicine used in adults to treat constipation caused by pain relief medicines called opioids.
Maltese: Moventig huwa mediċina li tintuża fl-adulti għall-kura ta' stitikezza kkawżata minn mediċini għas-serħan mill-uġigħ magħrufin bħala opjojdi.
English: † and ‡
Maltese: † u ‡
English: 84 hard capsules.
Maltese: 84 kapsula iebsa.
English: • The active substance is boceprevir.
Maltese: • Is-sustanza attiva hi boceprevir.
English: • immunosuppressants - tacrolimus, sirolimus, cyclosporine
Maltese: • immunosoppressanti - tacrolimus, sirolimus, cyclosporine
English: C/C C/T
Maltese: C/C
English: ORAL CONTRACEPTIVES Drospirenone/Ethinyl estradiol*: (drospirenone
Maltese: Drospirenone/Ethinyl estradiol*: (drospirenone
English: ≥ 1-log10 decline
Maltese: tnaqqis ≥ 1-log10
English: diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil)
Maltese: amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil)
English: < 1-log10 decline
Maltese: tnaqqis < 1-log10
English: Each capsule contains 56 mg of lactose monohydrate.
Maltese: Kull kapsula fiha 56 mg ta' lactose monohydrate.
English: IL28B rs12979860 Genotype
Maltese: Ġenotip IL28B rs12979860
English: Boceprevir is primarily metabolized by aldoketo reductase (AKR).
Maltese: Boceprevir huwa metabolizzat prinċipalment b'aldoketo reductase (AKR).
English: • statins - simvastatin or lovastatin
Maltese: • statins - simvastatin jew lovastatin
English: Please see "Possible side effects" for more information.
Maltese: Jekk jogħġbok ara “Effetti sekondarji possibbli” għal aktar informazzjoni.
English: • The other ingredients are sodium lauryl sulfate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pre-gelatinized starch, magnesium stearate, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin, and shellac.
Maltese: • Is-sustanzi l-oħra huma sodium lauryl sulfate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pre-gelatinized starch, magnesium stearate, iron oxide isfar (E 172), iron oxide aħmar (E 172), titanium dioxide (E171), gelatin, u shellac.
English: The subjects included 62% (104/168) genotype 1a and 38% (63/168) genotype 1b.
Maltese: L-individwi inkludew 62% (104/168) ta' ġenotip 1a u 38% (63/168) ta' ġenotip 1b.
English: Neutrophils (see section 4.4)
Maltese: Newtrofili (ara sezzjoni 4.4)
English: Capsule shell:
Maltese: Kontenut tal-kapsula:
English: • HIV protease inhibitors - atazanavir, darunavir, lopinavir, ritonavir
Maltese: • inibituri tal-protease ta' HIV - atazanavir, darunavir, lopinavir, ritonavir
English: 3 and/or serum albumin < 35 g/L and/or signs of coagulopathy (International Normalized Ratio (INR) > 1.7) at baseline.
Maltese: 3 u/jew serum albumin < 35 g/L u/jew sinjali ta' koagulapatija (Proporzjon Normalizzat Internazzjonali (INR) > 1.7) fil-linja bażi.
English: • HIV non-nucleoside reverse transcriptase inhibitor - efavirenz, etravirine
Maltese: • inibituri ta' non-nucleoside reverse transcriptase tal-HIV - efavirenz, etravirine
English: Cholecystitis*
Maltese: Koleċistite*
English: • antiarrhythmic medicines- amiodarone, quinidine
Maltese: • mediċini kontra l-arritmiji - amiodarone, quinidine
English: • lumefantrine and halofantrine - anti-malaria medicines
Maltese: • lumefantrine u halofantrine - mediċini kontra l-malarja
English: • The Physician Educational Materials (PEM)
Maltese: • Il-Materjali Edukattivi għat-Tabib (PEM - Physician Educational Materials)
English: (Refer to the stopping rule in Table 1 for all patients.)
Maltese: (Irreferi għar-regola biex twaqqaf f'Tabella 1 għall-pazjenti kollha).
English: Point estimate of the difference (Victrelis-RGT minus VictrelisPR48) [95% CI]
Maltese: Punt ta' stima tad-differenza (Victrelis-PR48 imnaqqas minn Victrelis-RGT) [95% CI]
English: Multipack: 336 (4 packs of 84) hard capsules
Maltese: 336 (4 pakketti b'84) kapsula iebsa
English: Victrelis contains lactose.
Maltese: Victrelis fih lactose.
English: • intravenous sedatives - benzodiazepines (e.g., alprazolam, midazolam, triazolam)
Maltese: • sedattivi li jingħataw ġol-vina - benzodiazepines (eż., alprazolam, midazolam, triazolam)
English: %, (n/N) 73 (80/110) 79 (90/114) EOT %, (n/N) 86 (95/110) 89 (101/114) Relapse
Maltese: %, (n/N) 73 (80/110) 79 (90/114) 25 (17/67) EOT %, (n/N) 86 (95/110) 89 (101/114) 37 (25/67) Irkadar
English: Adverse reactions are listed by System Organ Class (see Table 3).
Maltese: Reazzjonijiet avversi huma elenkati skont il-Klassi tas-Sistemi u tal-Organi (ara Tabella 3).
English: Boceprevir is an inhibitor of the HCV NS3 protease.
Maltese: Boceprevir huwa impeditur tal-protease NS3 ta' HCV.
English: • antifungal medicines - ketaconazole, itraconazole, posaconazole, voriconazole
Maltese: • mediċini kontra l-moffa - ketoconazole, itraconazole, posaconazole, voriconazole
English: Sustained Virologic Response (SVR)
Maltese: Rispons Viroloġiku Miżmum (SVR)
English: Use in patients with rare hereditary disorders
Maltese: Użu f'pazjenti b'disturbi ereditarji rari
English: Victrelis contains lactose (a type of sugar).
Maltese: Victrelis fih lactose (tip ta' zokkor).
English: MSD Polska Sp.z o.o.
Maltese: MSD Α.Φ.Β.Ε.Ε.
English: The SVR rate was 62.5% (40/64) in subjects treated with Victrelis in combination with PR and 29.4% (10/34) in subjects treated with PR alone (see Table 6).
Maltese: Ir-rata ta' SVR kienet ta' 62.5% (40/64) fil-pazjenti li ngħataw Victrelis f'kombinazzjoni ma' PR u 29.4% (10/34) fil-pazjenti li ngħataw PR waħdu (ara Tabella 6).
English: Exploratory pharmacogenomic analysis of IL28B in phase 3 studies of Victrelis
Maltese: Analiżi farmakoġenomika esploratorja ta' IL28B fl-istudji ta' fażi 3 ta' Victrelis
English: Among the variants, 91% of V36M, 98% of T54A, 71% of T54S, 78% of V55A, 76% of R155K, 92% of A156S, 96% of I/V170A, 77% of R155K+T54S and 95% of R155K+V36M were undetectable by population sequencing.
Maltese: Fost il-varjanti, 91% ta' V36M, 98% ta' T54A, 71% ta' T54S, 78% ta' V55A, 76% ta' R155K, 92% ta' A156S, 96% ta' I/V170A, 77% ta' R155K+T54S u 95% ta' R155K+V36M ma setgħux jitkejlu permezz ta' sekwenzar tal-popolazzjoni.
English: Pack sizes: carton of 84 hard capsules and multipack containing 336 (4 packs of 84) hard capsules.
Maltese: Daqsijiet tal-pakkett: kartuna ta' 84 kapsula iebsa u multipack li fih 336 (4 pakketti ta' 84) kapsula iebsa.
English: Anaemia*, neutropenia* Leukopenia*, thrombocytopenia*, pancytopenia,
Maltese: Anemija*, newtropenija* Lewkopenija*, tromboċitopenija*, panċitopenija,
English: Table 10 Sustained Virologic Response (SVR) rates by IL28B rs12979860 genotype
Maltese: Tabella 10 Rati ta' Rispons Viroloġiku Miżmum (SVR) skont il-ġenotip IL28B rs12979860
English: HCV protease monotherapy
Maltese: Monoterapija b'HCV protease
English: Victrelis 200 mg hard capsules
Maltese: Victrelis 200 mg kapsuli ibsin
English: Sarcoidosis*, porphyria non-acute
Maltese: Sarkojdożi*, porfirja mhux akuta
English: {MM/YYYY}
Maltese: Ελλάδα
English: Victrelis 200 mg hard capsules boceprevir
Maltese: Victrelis 200 mg kapsuli ibsin boceprevir
English: The majority of subjects (87%; 85/98) were taking a ritonavir-boosted HIV protease inhibitor (PI) combined with HIV nucleoside reverse transcriptase inhibitors (NRTIs).
Maltese: Il-maġġoranza tal-individwi (87%; 85/98) kienu qed jieħdu inibitur protease (PI) tal-HIV imsaħħaħ b'ritonavir flimkien ma' nucleoside reverse transcriptase inhibitors (NRTIs) talHIV.
English: Clinical Study
Maltese: Studju kliniku
English: The percentage of patients with Grades 3-4 neutropenia (neutrophil counts < 0.75 x 10
Maltese: Ilperċentwal ta' pazjenti b'newtropenija ta' Gradi 3-4 (għadd ta' newtrofili <0.75 x 10
English: Mean age of subjects randomized was 52.7 years.
Maltese: L-età medja tal-individwi magħżula b'mod każwali kienet ta' 52.7 snin.
English: IL28B rs12979860 was genotyped in 653 of 1,048 (62%) subjects in SPRINT-2 (previously untreated) and 259 of 394 (66%) subjects in RESPOND-2 (previous treatment failure) [see section 5.1 for the clinical trial descriptions].
Maltese: IL28B rs12979860 kien ġenotajpjat f'653 minn 1,048 (62%) individwu fi SPRINT-2 (mhux ikkurati qabel) u 259 minn 394 (66%) individwu f'RESPONS-2 (ma ħadmitx fuqhom kura li ngħataw qabel) [ara sezzjoni 5.1 għaddeskrizzjonijiet tal-provi kliniċi].
English: 3 mg daily + ethinyl estradiol 0.02 mg daily + Victrelis 800 mg three times daily)
Maltese: 3 mg kuljum + ethinyl estradiol 0.02 mg kuljum + Victrelis 800 mg tliet darbiet kuljum)
English: ASSESSMENT* (HCV-RNA Results
Maltese: STIMA* (Riżultati tal-RNA ta' HCV
English: 1 plasma HCV-RNA at Follow-up Week (FW) 24.
Maltese: 1 fil-Ġimgħa tal-Follow-up (FW) 24.
English: Potent CYP3A4 inducers
Maltese: • indutturi ta' CYP3A4
English: drospirenone AUC ↑ 99% drospirenone Cmax ↑ 57%
Maltese: L-AUC ta' drospirenone ↑ 99% Is-Cmax ta' drospirenone ↑ 57%
English: Continue with all three medicines (peginterferon alfa and ribavirin [PR] + Victrelis) and finish through Treatment Week 28 (TW 28).
Maltese: Kompli bit-tliet mediċini kollha (peginterferon alfa u ribavirin [PR] + Victrelis) u ieqaf filĠimgħa ta' Kura 28 (TW 28).
English: Combined use with peginterferon alfa-2a as compared to alfa-2b:
Maltese: Użu kombinat ma' peginterferon alfa-2a meta mqabbel ma' alfa-2b:
English: atorvastatin AUC ↑ 130% atorvastatin Cmax ↑ 166%
Maltese: L-AUC ta' atorvastatin ↑ 130% Is-Cmax ta' atorvastatin ↑ 166%
English: • Peginterferon alfa-2b + ribavirin for 48 weeks (PR48).
Maltese: • Peginterferon alfa-2b + ribavirin għal 48 ġimgħa (PR48).
English: The safety profile of Victrelis in HCV/HIV-1 co-infected patients (n=64) was overall similar to the safety profile in mono-infected HCV patients.
Maltese: Il-profil tas-sigurtà ta' Victrelis f'pazjenti ko-infettati bl-HCV/HIV-1 (n=64) kien b'mod ġenerali simili għall-profil tas-sigurtà f'pazjenti infettati biss bl-HCV.
English: Angioedema (see section 4.4), drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, Stevens-Johnson syndrome Musculoskeletal and connective tissue disorders Arthralgia, myalgia
Maltese: Anġjoedema (ara sezzjoni 4.4), sindrome ta' raxx minħabba l-mediċina b'sintomi ta' esinofilja u sintomi sistemiċi (DRESS), sindromu ta' Stevens-Johnson Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Artralġja, mijalġja
English: Clinical data (semen analyses and inhibin B levels - [a glycoprotein produced by Sertoli cells - used as a surrogate marker of testicular function]) showed no evidence of altered testicular function.
Maltese: Dejta klinika (analiżi tas-semen u livelli ta' inhibin B - [glikoproteina li jipproduċuha ċ-ċelluli ta' Sertolili tintuża bħala markatur li indirettament ikejjel il-funzjoni tat-testikoli]) ma wriet l-ebda evidenza ta' funzjoni mibdula fit-testikoli.
English: • birth control medicines - drospirenone
Maltese: • mediċini għal kontroll tat-twelid - drospirenone
English: Daily doses of 3,600 mg have been taken by healthy volunteers for 5 days without untoward symptomatic effects.
Maltese: Dożi ta' 3,600 mg kuljum ittieħdu minn voluntiera f'saħħithom għal 5 ijiem mingħajr sintomi ta'
English: The majority of the anaemia subjects received erythropoietin when haemoglobin levels were ≤ 10 g/dL (or 6.2 mmol/L).
Maltese: Il-maġġoranza tal-individwi bl-anemija rċivew erythropoietin meta l-livelli tal-emoglobina kienu ≤ 10 g/dL (jew 6.2 mmol/L).