FrancophonIA/ELRC3.0 huggingface dataset:
English: Nervous system disorders Very common headache Common peripheral neuropathy, dizziness headache, peripheral neuropathy, dizziness
Maltese: Disturbi fis-sistema nervuża Komuni ħafna uġigħ ta' ras Komuni newropatija periferika, sturdament uġigħ ta' ras, newropatija periferika, sturdament
English: Median time to onset was 1.4 months (range: 0.027.9).
Maltese: Ħin medjan sal-bidu kien ta' 1.4 xhur (firxa: 0.0-27.9).
English: Serious lung infection (pneumonia), bronchitis
Maltese: Mhux komuni pulmonitea, bronkite
English: Although ECOG status, baseline glomerular filtration rate (GFR), albumin, body weight, and mild hepatic impairment had an effect on nivolumab CL, the effect was not clinically meaningful.
Maltese: Għalkemm l-istat tal-ECOG, ir-rata ta' filtrazzjoni glomerulari (glomerular filtration rate, GFR), albumina, piż u indeboliment talfwied ħafif, kellhom effett fuq nivolumab CL, l-effett ma kienx klinikament notevoli.
English: Of the 2022 patients who were treated with nivolumab monotherapy 3 mg/kg every 2 weeks and evaluable for the presence of anti-product-antibodies, 231 patients (11.4%) tested positive for treatment-emergent anti-product-antibodies with fifteen patients (0.7 %) testing positive for neutralising antibodies.
Maltese: Mill-2022 pazjent li ġew ikkurati b'monoterapija ta' Nivolumab 3 mg/kg kull ġimagħtejn, u evalwabbli għall-preżenza ta' antikorpi kontra l-prodott, 231 pazjent (11.4%) li ttestjaw pożittivi għal antikorpi kontra l-prodott li seħħew minħabba l-kura, bi ħmistax-il pazjent (0.7%) jittestjaw pożittivi għal antikorpi newtralizzanti.
English: The median duration of time from initial diagnosis to randomisation was 0.4 years in both the nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg and sunitinib groups.
Maltese: It-tul medjan taż-żmien mid-dijanjożi inizjali sal-għażla każwali kien 0.4 snin kemm fil-grupp nivolumab 3 mg/kg flimkien ma' ipilimumab 1 mg/kg u fil-grupp sunitinib.
English: Nivolumab baseline CL in adjuvant melanoma patients was approximately 40% lower and steady state CL approximately 20 % lower relative to advanced melanoma.
Maltese: IsCL tal-linja bażi ta' Nivolumab f'pazjenti b'melanoma aġġuvanti kienet madwar 40% iktar baxxa u sCL fi stat fiss kienet madwar 20% iktar baxxa meta mqabbla ma' melanoma avvanzata.
English: Among these 37 patients, treatment with nivolumab resulted in an ORR of 59.5% (22/37).
Maltese: Fost dawn it-37 pazjent, il-kura b'nivolumab irriżultat f'ORR ta' 59.5% (22/37).
English: Severe pneumonitis or interstitial lung disease, including fatal cases, has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Maltese: B'monoterapija ta' Nivolumab jew b'nivolumab mogħti flimkien ma' ipilimumab ġiet osservata pulmonite severa jew marda interstizjali severa tal-pulmun, li jinkludu każijiet fatali (ara sezzjoni 4.8).
English: Per the AJCC 8th edition, this corresponds to patients with lymph node involvement or metastases.
Maltese: Skont it-8 edizzjoni talAJCC, dan jikkorrespondi għal pazjenti b'involviment tan-nodi limfatiċi jew metastażi.
English: OPDIVO as monotherapy
Maltese: OPDIVO bħala monoterapija
English: After opening
Maltese: U LUŻU
English: Data from SCCHN and adjuvant melanoma patients 75 years of age or older are too limited to draw conclusions on this population (see section 5.1).
Maltese: Tagħrif minn pazjenti tal-SCCHN u melanoma aġġuvanti ta' 75 sena jew aktar huwa limitat wisq biex jinstiltu konklużjonijiet dwar din il-popolazzjoni (ara sezzjoni 5.1).
English: Among 128 patients who discontinued nivolumab in combination with ipilimumab due to adverse reaction after 18 months of follow-up, median PFS was 16.7 months (95% CI: 10.2, NA).
Maltese: Fost 128 pazjent li waqfu jieħu nivolumab flimkien ma' ipilimumab minħabba reazzjoni avversa wara 18-il xahar ta' segwitu, il-medjan PFS kien 16.7 xhur (95% CI: 10.
English: Quality of life (QoL) with nivolumab remained stable and close to baseline values during treatment, as assessed by valid and reliable scales like the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EQ-5D utility index and visual analog scale (VAS).
Maltese: QLQ-C30 u l-indiċi tal-utilità tal-EQ-5D u l-iskala anolog viżiva (visual analog scale, VAS).
English: OPDIVO in combination with ipilimumab Melanoma
Maltese: OPDIVO flimkien ma' ipilimumab Melanoma
English: Bristol-Myers Squibb AB Tel: + 46 8 704 71 00
Maltese: Bristol-Myers Squibb Polska Sp. z o.o. Tel.: + 48 22 2606400
English: No overall differences in safety were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Maltese: L-ebda differenzi ġenerali fis-sigurtà ma kienu rrapportati bejn pazjenti anzjani (≥ 65 sena) u pazjenti iżgħar (< 65 sena).
English: Chanhold (selamectin)
Maltese: Chanhold (selamektina)
English: The medicine is available as a spot-on solution in 2 different concentrations (6% and 12%) and in tubes of various strengths (15, 30, 45, 60, 120, 240 and 360 mg).
Maltese: Il-mediċina tiġi bħala soluzzjoni għal użu lokalizzat f'2 konċentrazzjonijiet differenti (6 % u 12 %) u f'tubi ta' diversi qawwiet (15, 30, 45, 60, 120, 240 u 360 mg).
English: Further information on Chanhold can be found on the Agency's website: ema.europa.eu/Find medicines/veterinary/EPAR/chanhold.
Maltese: ema.europa.eu/Find medicines/veterinary/EPAR/chanhold.
English: Chanhold received a marketing authorisation valid throughout the EU on 17 April 2019.
Maltese: Chanhold ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fi 17/04/2019.
English: Other information about Chanhold
Maltese: Informazzjoni oħra dwar Chanhold
English: Chanhold contains the active substance selamectin and is a ‘generic medicine'.
Maltese: Chanhold fih is-sustanza attiva selamektina u huwa ‘mediċina ġenerika'.
English: What are the benefits and risks of Chanhold?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Chanhold?
English: Chanhold contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin' class.
Maltese: Chanhold fih is-selamektina, li hija mediċina antiparassitika li tappartjeni għall-klassi ‘avermektina'.
English: It can also be used as part of a treatment for flea allergy dermatitis (skin inflammation), to prevent heartworm disease in cats and dogs, to treat ear mites in cats and dogs, to treat adult intestinal roundworms and intestinal hookworms in cats, to treat adult intestinal roundworms in dogs, to treat biting lice infestations in cats and dogs, to treat sarcoptic mange (scabies) in dogs.
Maltese: Din tista' tintuża wkoll bħala parti minn kura għal dermatite allerġika għallbriegħed (infjammazzjoni fil-ġilda), biex jipprevjeni l-marda tal-heartworm fil-qtates u fil-klieb, biex jikkura d-dud tal-widnejn fil-qtates u l-klieb, biex jikkura roundworms adulti intestinali u hookworms intestinali fil-qtates, biex jikkura roundworms adulti intestinali fil-klieb; biex jikkura l-infestazzjonijiet mill-qamel li jigdem fil-qtates u fil-klieb, biex jikkura l-iskabbja sarkoptika (skabbja) fil-klieb.
English: How has Chanhold been studied?
Maltese: Kif ġie studjat Chanhold?
English: Chanhold is an antiparasitic medicine used to treat and prevent infestations with parasites that live on the skin or in the fur of cats and dogs, such as fleas and mites, as well as treating worm parasites that live inside the body.
Maltese: Chanhold huwa mediċina antiparassitika li tintuża għall-kura u l-prevenzjoni ta' infestazzjonijiet ta' parassiti li jgħixu fuq il-ġilda jew fil-pil tal-qtates u l-klieb, bħall-briegħed u d-dud, kif ukoll li jikkuraw parassiti tad-dud li jgħixu fil-ġisem.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Stronghold, and do not need to be repeated for Chanhold.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użi awtorizzati bil-mediċina ta' referenza, Stronghold, u ma għandhomx għalfejn jiġu ripetuti għal Chanhold.
English: The precautions are the same as for the reference medicine since Chanhold is a generic medicine.
Maltese: Il-prekawzjonijiet huma bħal dawk tal-mediċina ta' referenza minħabba li Chanhold huwa mediċina ġenerika.
English: This means that Chanhold contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Stronghold.
Maltese: Dan ifisser li Chanhold fih listess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) msejħa Stronghold.
English: There was no need for ‘bioequivalence' studies to investigate whether Chanhold is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' ‘bijoekwivalenza' biex jiġi investigat jekk Chanhold jiġix assorbit b'mod simili għall-mediċina ta' referenza biex jipproduċi l-istess livell ta' sustanza attiva fid-demm.
English: Because Chanhold is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Chanhold huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk talmediċina ta' referenza.
English: It is used in the following ways: to treat and prevent flea infestations in cats and dogs, by killing adult fleas, their larvae and their eggs on the animal, and in the litters of pregnant or nursing cats or dogs.
Maltese: Jintuża bil-modi li ġejjin: biex jikkura u jipprevjeni infestazzjonijiet ta' briegħed fil-qtates u l-klieb, billi joqtol il-briegħed adulti, il-larva tagħhom u l-bajd tagħhom fuq l-annimal, u fil-boton ta' qtates tqal jew qtates jew klieb li qed ireddgħu.
English: ATCvet code: QI06AH08.
Maltese: Q106AH08
English: Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 LYON
Maltese: Laboratorju ta' Lyon Gerland 254, Avenue Marcel Mérieux 69007 LYON
English: Laboratory of Lyon Porte des Alpes Rue de l'aviation
Maltese: Laboratorju ta' Lyon Porte des Alpes Rue de l'aviation
English: Lyophilisate (10x1 dose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Maltese: Lijofiliżat (doża 10x1 ) + solvent (10x1 ml) Lijofiliżat (doża 50 x 1) + solvent (50 x 1 ml)
English: Date of first authorisation: 23/02/2005 Date of last renewal: 15/01/2010
Maltese: Data tal-aħħar tiġdid: 15/01/2010
English: EU/2/04/051/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/051/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Maltese: EU/2/04/051/001 Lijofiliżat (10 fliexken ta' doża ) + solvent (10 fliexken ta' doża) EU/2/04/051/002 Lijofiliżat (50 flixkun ta' doża) + solvent (50 flixkun ta' doża)
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs.
Maltese: Immunizzazzjoni attiva tal-qtates ta' 8 ġimgħat u akbar: - kontra r-rinotrakeite virali fil-qtates biex tnaqqas sinjali kliniċi, - kontra l-infezzjoni tal-kaliċivirus biex tnaqqas sinjali kliniċi.
English: EXP (mm/yyyy)
Maltese: EXP (XX/SSSS)
English: Stimulates active immunity against feline rhinotracheitis herpesvirus and feline calicivirus.
Maltese: Tistimola immunità attiva kontra l-herpesvajrus tar-rinotrakeite fil-qtates u kaliċivirus fil-qtates.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens .................................. ≥ 2.0 ELISA U.
Maltese: Herpesvajrus attenwat tar-rinotrakeite fil-qtates (FHV strejn F2) ................................... ≥ 104.9 CCID501 kaliċivirus fil-qtates inattivat (strejn FCV 431 u G1) ........................................ antiġeni ≥ 2.0 ELISA U.
English: Sucrose
Maltese: Sukrozju
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI
English: Water for injections ..................................................................................................................... q.s.
Maltese: Ilma għall-injezzjoni . ............................................................................................................................................ .q.s. ml. 1: doża infettiva tas-cell culture 50 %
English: Rue de l'Aviation
Maltese: Laboratoire Porte des Alpes Rue de l'Aviation
English: Purevax RC lyophilisate and solvent for suspension for injection.
Maltese: VETERINARJU Purevax RC, lijofiliżat u solvent għal suspensjoni għall-injezzjoni.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pack containing 10 bottles of lyophilisate and 10 bottles of solvent Pack containing 50 bottles of lyophilisate and 50 bottles of solvent
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Pakkett li għandu 10 fliexken ta' lijofiliżat u 10 fliexken ta' solvent Pakkett li għandu 50 flixkun ta' lijofiliżat u 50 flixkun ta' solvent
English: Excipient:
Maltese: Lijofiliżat:
English: Per dose of 1 ml: Lyophilisate:
Maltese: U KWANTITATTIVA Għal kull doża ta' ml:
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U.
Maltese: FHV (strejn F2). .................................................................................................................. ≥ 104.9 CCID50 FCV (strejn 431 u G1). ................................................................................................... ≥ 2.0 ELISA U.
English: Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium or plastic cap.
Maltese: Flixkun tal-ħġieġ ta' Tip I li fih doża ta' lijofiliżat u flixkun tal-ħġieġ ta' Tip I li fih ml ta' solvent, ittnejn magħluqin b'tapp tal-butyl elastomer u ssiġillati b'tapp tal-aluminju jew tal-plastik.
English: In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Maltese: F'kundizzjonijiet normali tal-użu, jista' jkun hemm apatija u anoressja li jgħaddu, u wkoll żieda fit temperatura tal-ġisem (li ddum normalment għal ġurnata jew tnejn).
English: Lyophilisate:
Maltese: OĦRA
English: WITHDRAWAL PERIOD(s)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq
English: Lyophilisate and solvent for suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Lijofiliżat u solvent għal suspensjoni għall-injezzjoni.
English: Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.
Maltese: Pakkett li għandu 50 flixkun ta' doża ta' lijofiliżat u 50 flixkun ta' ml ta' solvent.
English: Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent.
Maltese: Pakkett li għandu 10 fliexken ta' doża ta' lijofiliżat u 10 fliexken ta' ml ta' solvent.
English: Where high levels of maternal antibodies against rhinotracheitis or calicivirosis components are expected to be present (e.g. in kittens of 9-12 weeks of age borne from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Maltese: Fejn livelli għolja ta' antikorpi materni kontra l-komponenti tar-rinotrakeite u tal-kaliċivirosi huma mistennija li jkunu preżenti (per eżempju fi frieħ ta' bejn 9 u 12-il ġimgħa mwielda minn nisa li kienu mlaqqma qabel it-tqala u/jew kellhom espożizzjoni preċedenti magħrufa jew issuspettata għallpatoġenu/patoġeni), l-ewwel kors ta' tilqima għandu jiġi rimandat sal-età ta' 12-il ġimgħa
English: Gentamicin, at most ....................................................................................................................... 16.5 µg
Maltese: Ilma għall-injezzjonijiet ............................................................................................................... q.s. ml. 1: doża infettiva tas-cell culture 50%
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Maltese: .8 Effetti fuq prodotti mediċinali oħra jew effetti oħra Hemm informazzjoni dwar is-sigurtà u l-effikaċja li turi li dan il-vaċċin jista jitħallat mal-vaċċin talMerial mingħajr aġġuvant kontra l-lewkemja fil-qtates u/jew jiġi amministrat fl-istess ġurnata iżda mhux jitħallat mal-vaċċin bl-aġġuvant tal-Merial kontra r-rabbja.
English: Onsets of immunity have been demonstrated 1week after primary vaccination course for rhinotracheitis and calicivirus components.
Maltese: - tilqim sussegwenti għandhom jingħataw f'intervalli sa tliet snin għall-komponenti tarrinotrakeite u tal-kaliċivirosi.
English: 6 cells/ml).
Maltese: 6 ċelluli/ml).
English: EU/1/14/924/001 (7 capsules)
Maltese: EU/1/14/924/001 (7 kapsuli) EU/1/14/924/002 (28 kapsuli)
English: B-2340 Beerse Belgium
Maltese: B-2340 Beerse
English: HPC3011 (RESTORE; Phase 3)
Maltese: HPC3011 (RESTORE; Fażi 3)
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Maltese: MARKETING AUTHORISATION
English: OLYSIO capsules contain lactose monohydrate.
Maltese: Il-kapsuli OLYSIO fihom lactose monohydrate.
English: Date of first authorisation: 14 May 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 14 ta' Mejju 2014
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: NUMBER(S)
English: UAB "JOHNSON & JOHNSON" Geležinio Vilko g. 18A LT-08104 Vilnius Tel: +370 5 278 68 88
Maltese: JOHNSON" Geležinio Vilko g. 18A LT-08104 Vilnius Tel: +370 5 278 68 88
English: * darunavir/ritonavir + 50 mg simeprevir compared to
Maltese: * darunavir/ritonavir + 50 mg simeprevir meta mqabbel
English: rash*, pruritus*
Maltese: raxx*, ħakk*
English: placebo % (n/N)
Maltese: plaċebo % (n/N)
English: Study C206
Maltese: Studju C206
English: Study HPC3021 N = 40 % (n/N)
Maltese: Studju HPC3021 N = 40 % (n/N)
English: Slovenská republika Johnson & Johnson s.r.o.
Maltese: Slovenská republika Johnson & Johnson s.r.o. CBC
English: OLYSIO contains lactose (a type of sugar).
Maltese: OLYSIO fih lactose (tip ta' zokkor).
English: Capsule content Sodium lauryl sulfate Magnesium stearate Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate
Maltese: Kontenut tal-kapsula Sodium lauryl sulfate Magnesium stearate silica anidru kollojdali Croscarmellose sodium
English: Antibiotics - macrolides (systemic administration) Azithromycin
Maltese: Antibijotiċi - makrolidi (amministrazzjoni sistemika)
English: Study HPC2014
Maltese: Fl-istudju HPC2014
English: Viral breakthrough rates were 24% (11/45), 20% (5/25) and 11% (4/36) in patients with genotype 4a, 4d and 4/other, respectively.
Maltese: Ir-rati ta' progress virali kienu 24% (11/45), 20% (5/25) u 11% (4/36) f'pazjenti b'ġenotip 4a, 4d u 4/oħrajn, rispettivament.
English: 24 weeks N = 31
Maltese: 24 ġimgħa N = 31
English: The adverse reactions are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very
Maltese: Irreazzjonijiet avversi huma elenkati skont il-klassifika tas-sistema tal-organi (SOC - system organ class) u l-frekwenza: (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000).
English: - Keep this leaflet.
Maltese: Popolazzjoni ta' pazjenti
English: - OLYSIO contains the active substance ‘simeprevir'.
Maltese: - OLYSIO fih is-sustanza attiva ‘simeprevir'.
English: * Ketoconazole: pending further ATC classification.
Maltese: * Ketoconazole: aktar klassifikazzjoni ta' ATC pendenti.
English: Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000
Maltese: Mangion Building, Triq Ġdida fi Triq Valletta
English: Simeprevir is classified as a PBT (persistent, bioaccumulative and toxic) substance (see section 6.6).
Maltese: Simeprevir huwa kklassifikat bħala sustanza PBT (persistenti, bijoakkumulattiv u tossiku) (ara sezzjoni 6.6).
English: Excipient with known effect: each capsule contains 78.4 mg of lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf: kull pillola fiha 78.4 mg lactose (bħala monohydrate).
English: Less than 10% Less than 10% Less than 10%
Maltese: Inqas minn 10% Inqas minn 10% Inqas minn 10%
English: - The other ingredients are sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, gelatin, titanium dioxide (E171), iron oxide black (E172) and shellac (E904).
Maltese: - Is-sustanzi l-oħra huma sodium lauryl sulfate, magnesium stearate, silica anidru kollojdal, croscarmellose sodium, lactose monohydrate, gelatin, titanium dioxide (E171), iron oxide black
English: Comparison based on historic controls.
Maltese: Tqabbil ibbażżat fuq kontrolli storiċi.
English: Antiretroviral - non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz
Maltese: Antiretrovirali - impedituri mhux nukleosidi ta' reverse transcriptase (NNRTIs - nonnucleoside reverse transcriptase inhibitors)
English: Opaque polyvinylchloride/polyethylene/polyvinylidenechloride (PVC/PE/PVDC) aluminium push-through blister strips of 7 capsules.
Maltese: Folji opaki tal-polyvinylchloride/polyethylene/polyvinylidenechloride (PVC/PR/PVDC) aluminium
English: In vitro, simeprevir induced a phototoxic response on BALB/c 3T3 fibroblasts after UVA exposure, in the absence and presence of protein supplements.
Maltese: In vitro, simeprevir induċa rispons fototossiku fuq fibroplasts ta' BALB/c 3T3 wara esponiment UVA, fin-nuqqas u l-preżenza ta' supplimenti ta' proteini.
English: Table 12: Demographics and baseline characteristics (studies HPC3017 and HPC3018) HPC3017 N = 310
Maltese: Tabella 12: Id-demografika u l-karatteristiċi fil-linja bażi (studji HPC3017 u HPC3018) HPC3017 N = 310
English: In these patients the SVR12 rates were 89%, 93%, 75% and 90%, respectively.
Maltese: F'dawn il-pazjenti r-rati ta' SVR12 kienu 89%, 93%, 75% u 90%, rispettivament.
English: Other medicines and OLYSIO
Maltese: Mediċini oħra u OLYSIO
English: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Il-Belġju
English: Involvement of CYP2C8 and CYP2C19 cannot be excluded.
Maltese: L-involviment ta' CYP2C8 u CYP2C19 ma jistax jiġi eskluż.
English: Table 9: Antiviral activity of simeprevir 200 mg monotherapy (studies C201 and C202) Mean (SE) change in HCV RNA at day 7/8 (log10 IU/mL)
Maltese: Tabella 9: Attività antivirali ta' monoterapija b'simeprevir 200 mg (studji C201 u C202) Bidla medja (SE) f'HCV RNA f'jum 7/8 (log10 IU/ml)
English: The median simeprevir EC50 and EC90 values against a HCV genotype 1b replicon were 9.4 nM (7.05 ng/ml) and 19 nM (14.25 ng/ml), respectively.
Maltese: Il-valuri medjani ta' EC50 u EC90 ta' simeprevir kontra replikon ta' HCV ta' ġenotip 1b kienu 9.4 nM (7.05 ng/ml) u 19 nM (14.25 ng/ml) rispettivament.
English: Less than 1% of the administered dose was recovered in urine.
Maltese: Inqas minn 1% tad-doża amministrata kienet irkuprata fl-urina.
English: Respiratory, thoracic and mediastinal disorders: very common dyspnoea*
Maltese: Disturbi respiratorji, toraċiċi u medjastinali: komuni ħafna dispnea*
English: nelfinavir, nevirapine, ritonavir, saquinavir or tipranavir to treat HIV infection - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin or simvastatin to lower cholesterol
Maltese: nelfinavir, nevirapine, ritonavir, saquinavir jew tipranavir biex tiġi ttrattata infezzjoni ta' HIV - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin jew simvastatin biex inaqqas il