FrancophonIA/ELRC3.0 huggingface dataset:
English: Coadministration with medicinal products that strongly induce cytochrome P450 3A4 (CYP3A4) and P-glycoprotein transporter (P-gp) and thus may lead to lower exposure and loss of efficacy of Daklinza.
Maltese: L-għoti flimkien ma' prodotti mediċinali li jissensibilizzaw b'mod qawwi lil ċitokrom P450 3A (CYP3A4) u trasportatur ta' P-glikoproteina (P-gp) u minħabba f'hekk jista' jikkaġuna esponiment aktar baxx u telf ta' effikaċja ta' Daklinza.
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP07
Maltese: Antivirali li jaġixxu b'mod dirett, Kodiċi ATC:
English: 600 mg daily 400 mg daily 200 mg daily Discontinue ribavirin
Maltese: 600 mg kuljum 400 mg kuljum 200 mg kuljum
English: Because daclatasvir is highly protein bound (99%) and has a molecular weight >500, dialysis is unlikely to significantly reduce plasma concentrations of daclatasvir.
Maltese: Peress li daclatasvir jintrabat sew mal-proteini (99%) u għandu piż molekulari >500, id-dijalisi mhix probabbli tnaqqas b'mod sinifikanti l
English: Grade 3/4 increases in total bilirubin were observed in 5% of patients (all in patients with HIV coinfection who were receiving concomitant atazanavir, with Child-Pugh A, B, or C cirrhosis, or who
Maltese: Kienu osservati żidiet ta' Grad 3/4 fil-bilirubina totali f'5% tal-pazjenti (kollha f'pazjenti b'koinfezzjoni tal-HIV li kienu qegħdin jirċievu atazanavir konkomittanti, b'ċirrożi ta' Child-Pugh A, B jew C, jew li kellhom trapjant tal-fwied).
English: The most frequently detected NS5A RAVs included Q30E or Q30R in combination with L31M.
Maltese: L-aktar NS5A RAVs misjuba b'mod komuni kienu jinkludu Q30E jew Q30R flimkien ma' L31M.
English: ANTIVIRALS, HIV or HBV Protease inhibitors (PIs) Atazanavir 300 mg/ritonavir
Maltese: Antivirali oħra ta' HCV Peginterferon alfa 180 µg darba fil-ġimgħa u ribavirin
English: Coadministration with strong inducers of CYP3A4 and P-gp is contraindicated while dose adjustment of Daklinza is recommended when coadministered with moderate inducers of CYP3A4 and P-gp (see Table 4).
Maltese: L-għoti flimkien ta' indutturi qawwija ta' CYP3A4 u P-gp huwa kontraindikat filwaqt li l-aġġustament fid-doża ta' Daklinza huwa rakkomandat meta jingħata flimkien ma' indutturi moderati jew CYP3A4 u P-gp (ara Tabella 4).
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; therefore, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients (see the Summary of Product Characteristics for ribavirin).
Maltese: Effetti teratoġeniċi u/jew embrijoċidali sinifikanti ġew osservati fi speċi ta' annimali esposti għal ribavirin, għalhekk għandha tingħata attenzjoni estrema sabiex tiġi evitata t-tqala f'pazjenti nisa u fi sħab nisa ta' pazjenti rġiel (ara s-Sommarju talKaratteristiċi tal-Prodott għal ribavirin).
English: If you forget to take Daklinza It is important not to miss a dose of this medicine.
Maltese: Huwa importanti li ma taqbiżx doża ta' din il-mediċina.
English: ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital
Maltese: ewlieni fiċ-ċirkolazzjoni tal-prodrug
English: Digoxin 0.125 mg once daily (daclatasvir 60 mg once daily)
Maltese: Sofosbuvir 400 mg darba kuljum (daclatasvir 60 mg darba
English: The HCV RNA thresholds that trigger discontinuation of treatment (i.e. treatment stopping rules) are
Maltese: Illimiti ta' HCV RNA li jagħtu bidu għall-waqfien tal-kura (i.e. regoli ta' twaqqif tal-kura) huma
English: AI444042: Patients received daclatasvir 60 mg once daily (n=82) or placebo (n=42) plus pegIFN/RBV for 24 weeks.
Maltese: Il-pazjenti rċivew daclatasvir 60 mg darba kuljum (n=82) jew plaċebo (n=42) flimkien ma' IFN/RBV għal 24 ġimgħa.
English: NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg film-coated tablets
Maltese: Daklinza 30 mg pilloli
English: Ten percent of patients had compensated cirrhosis, and 75% of patients had IL-28B rs12979860 non-CC genotypes.
Maltese: Għaxra fil-mija ta' pazjenti kellhom ċirrożi kumpensata u 75% tal-pazjenti kellhom IL-28B rs12979860 mhux ġenotip CC.
English: Treatmentexperienced N=24
Maltese: Irċevew kura filpassat N=24
English: Telaprevir 500 mg q12h (daclatasvir 20 mg once daily)
Maltese: Darunavir 800 mg/ritonavir 100 mg darba kuljum (daclatasvir 30 mg darba
English: Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
Maltese: Kull pillola miksija b'rita fiha 60 mg ta' daclatasvir (bħala dihydrochloride).
English: The AUC value associated with this dose is 4-fold the clinical AUC exposure.
Maltese: Il-valur tal-AUC assoċjata ma' din id-doża kienet ta' 4 darbiet l-esponiment tal-AUC klinika.
English: In the majority of clinical studies of daclatasvir in combination with sofosbuvir or with peginterferon alfa and ribavirin, plasma HCV RNA values were measured using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System, with a lower limit of quantification (LLOQ) of 25 IU/ ml.
Maltese: Fil-maġġoranza tal-istudji kliniċi ta' daclatasvir flimkien ma' sofosbuvir jew ma' peginterferon alfa u ribavirin, il-valuri tal-HCV RNA fil-plażma tkejlu permezz tat-test tal-HCV COBAS TaqMan (verżjoni 2.0), sabiex jintuża mas-Sistema Pura Għolja, b'limitu aktar baxx ta' kwantifikazzjoni (LLOQ) ta' 25 IU/ ml.
English: Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets daclatasvir
Maltese: Informazzjoni għall-pazjent Daklinza 30 mg pilloli miksija b'rita Daklinza 60 mg pilloli miksija b'rita daclatasvir Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Regimen and duration
Maltese: Reżistenza inkroċjata
English: Fusion inhibitor Enfuvirtide
Maltese: IL-PRODOTT MEDIĊINALI
English: No clinically relevant antiviral activity was observed against a variety of RNA and DNA viruses, including HIV, confirming that daclatasvir, which inhibits a HCV-specific target, is highly selective
Maltese: Ma ġiet osservata l-ebda attività klinika rilevanti kontra varjetà ta' viruses ta' RNA u DNA, li jinkludu HIV, u dan jikkonferma li daclatasvir, li jimpedixxi mira speċifika ta' HCV, huwa selettiv ħafna għal
English: * Mainly interferon-based therapy, but 7 patients received sofosbuvir + ribavirin and 2 patients received a ** Cirrhosis was determined by liver biopsy (METAVIR F4) for 14 patients, FibroScan >14.6 kPa for 11 patients or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2 for 7 patients.
Maltese: ** Iċ-ċirrożi ġiet stabbilita permezz ta' bijopsija tal-fwied (METAVIR F4) għal 14-il pazjent, FibroScan ta' >14.6 kPa għal 11-il pazjent jew punteġġ ta' FibroTest ta' ≥0.75 u aspartate aminotransferase (AST): indiċi tal-proporzjon tal-plejtlits (APRI) ta' >2 għal 7 pazjenti.
English: Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Maltese: Kull pillola miksija b'rita fiha 30 mg ta' daclatasvir (bħala dihydrochloride).
English: Musculoskeletal and connective tissue disorders arthralgia, myalgia arthralgia, myalgia
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda raxx, alopeċja, ħakk, Disturbi muskolu-skeletriċi u tat-tessuti konnettivi artralġja, mijalġja artralġja, mijalġja
English: Refer to the Summary of Product Characteristics of ribavirin.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi talProdott ta' ribavirin.
English: For detailed recommendations regarding pregnancy and contraception, refer to the Summary of Product Characteristics for ribavirin and peginterferon alfa.
Maltese: Għal rakkomandazzjonijiet detalljati dwar it-tqala u l-kontraċezzjoni, irreferi għas-Sommarju talKaratteristiċi tal-Prodott għal ribavirin u peginterferon alfa.
English: 12 weeks therapy HCV Treatmentnaïve N=101
Maltese: 12-il ġimgħa ta' terapija Pazjenti li qatt ma ġew ikkurati qabel għal HCV N=101
English: Respiratory, thoracic and mediastinal disorders dyspnoea, dyspnoea exertional, cough, nasal diarrhoea, vomiting, abdominal pain, gastrooesophageal reflux disease, constipation, dry mouth, flatulence nausea, diarrhoea, abdominal pain
Maltese: Disturbi respiratorji, toraċiċi u medjastinali qtugħ ta' nifs, qtugħ ta' nifs minħabba l-istrapazz, sogħla konġestjoni fl dijarea, rimettar, uġigħ addominali, mard ta' rifluss gastrointestinali, stitikezza, ħalq xott, gass dardir, dijarea, uġigħ addominali
English: Italy
Maltese: España
English: Cmax: 0.95 (0.89, 1.02) Cmin: 1.17 (1.10, 1.24)
Maltese: ↔ Daclatasvir* AUC: 0.95 (0.82, 1.10) Cmass: 0.88 (0.78, 0.99)
English: Detectable HCV RNA at end of treatment
Maltese: HCV RNA mhux osservat
English: For 5 patients, cirrhosis status was indeterminate.
Maltese: F'5 pazjenti, listatus taċ-ċirrożi ma kienx determinat.
English: Cases of severe bradycardia and heart block have been observed when Daklinza is used in combination with sofosbuvir and concomitant amiodarone and/or other drugs that lower heart rate (see
Maltese: Każijiet ta' bradikardija severa u mblokkar tal-qalb ġew osservati meta Daklinza intuża flimkien ma' sofosbuvir u amiodarone konkomitanti u/jew mediċini oħrajn li jbaxxu r-rata ta' taħbit tal-qalb (ara s
English: CYP3A4 inhibition by ketoconazole
Maltese: CYP3A4 minn atazanavir/cobicistat:
English: Lamivudine Zidovudine Emtricitabine Abacavir
Maltese: KONDIZZJONIJIET U REKWIŻITI OĦRA TAL-AWTORIZZAZZJONI
English: Response was rapid (viral load at Week 4 showed that more than 97% of patients responded to therapy), and was not influenced by HCV subtype (1a/1b), IL28B genotype, or use of ribavirin.
Maltese: Ir-rispons kien malajr (tagħbija virali f'Ġimgħa 4 wera li aktar minn 97% ta' pazjenti rrispondew għat-terapija) u ma kienx influwenzat minn sottotip ta' HCV (1a/1b), ġenotip IL28B, jew l-użu ta' ribavirin.
English: Do not take Daklinza if you are taking any of the following medicines: phenytoin, carbamazepine, oxcarbazepine or phenobarbital, used to treat epileptic seizures rifampicin, rifabutin or rifapentine, antibiotics used to treat tuberculosis dexamethasone, a steroid used to treat allergic and inflammatory diseases medicines containing St. John's wort (Hypericum perforatum, a herbal preparation).
Maltese: Tiħux Daklinza jekk qed tieħu xi waħda minn dawn il-mediċini li ġejjin: phenytoin, carbamazepine, oxcarbazepine jew phenobarbital, użati fit-trattament ta' attakki rifampicin, rifabutin jew rifapentine, antibijotiċi użati fil-kura ta' tuberkulosi dexamethasone, sterojde użat biex jittratta mard allerġiku u infjammatorju mediċini li jkun fihom St.
English: Table 14: Treatment outcomes, daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV), treatment-naïve patients with HCV genotype 4
Maltese: Riżultati tat-trattament, daclatasvir flimkien ma' peginterferon alfa u ribavirin (pegIFN/RBV), pazjenti b'HCV ġenotip 4 li ma kinux ġew ittrattati qabel Studju AI444010 daclatasvir + pegIFN/RBV N=12
English: Treatment-naïve
Maltese: Tmiem ittrattament
English: Table 13: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 24 weeks, HCV genotype 3 patients with cirrhosis in Study ALLY-3C Treatment-naïve N=54
Maltese: Tabella 13: Riżultati tal-kura, daclatasvir flimkien ma' sofosbuvir u ribavirin għal 24 ġimgħa, pazjenti b'HCV ta' ġenotip 3 b'ċirrożi fi Studju ALLY-3 Qatt ma rċevew kura fil-passat
English: Coadministration of Daklinza with systemic dexamethasone or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' Daklinza ma' dexamethasone sistemiku jew ma' indutturi qawwija oħra ta' CYP3A4 hu kontraindikat (ara sezzjoni 4.3).
English: AI444043: 301 treatment-naïve patients with HCV genotype 1 infection and HIV co-infection (10% with compensated cirrhosis) were treated with daclatasvir in combination with pegIFN/RBV.
Maltese: 301 pazjent li qatt ma ġew ikkurati qabel b'infezzjoni tal-ġenotip 1 tal-HCV u koinfezzjoni tal-HIV (10% b'ċirrożi kumpensata) kienu kkurati b'daclatasvir flimkien ma' pegIFN/RBV.
English: Observed emergent NS5A resistance-associated variants are reported in Table 15.
Maltese: Varjanti assoċjati mar-reżistenza ta' NS5A li żviluppaw li ġew osservati huma rrapportati fit-Tabella 15.
English: Among 302 patients who achieved SVR12 with daclatasvir + pegIFN/RBV with a median duration of post-SVR12 follow-up of 44 months, 2% (n=6) of patients relapsed.
Maltese: SVR12 ta' 44 xahar, 2% (n=6) ta' pazjenti kienu rkadaw.
English: Bristol-Myers Squibb Pharmaceuticals uc
Maltese: Bristol-Myers Squibb Pharma EEIG Plaza 254
English: The relapse rate was around 15%, and similar for patients with Child-Pugh A, B and C. The programmes do not allow for a direct comparison of efficacy between the 12- and 24-week regimens.
Maltese: Ir-rata ta' rikaduta kienet ta' madwar 15%, u kienet simili għal pazjenti b'Child-Pugh A, B u Ċ.
English: No dose adjustment of Daklinza or raltegravir is required.
Maltese: Kontraċettivi orali oħrajn ma ġewx studjati.
English: Treatment outcomes in study AI444010 for patients with HCV genotype 4 are presented in Table 14.
Maltese: Ir-riżultati tat-trattament fi studju AI444010 għal pazjenti b'HCV ġenotip 4 huma ppreżentati f'Tabella 14.
English: Daklinza must not be administered as monotherapy.
Maltese: Daklinza m'għandux jingħata bħala monoterapija.
English: dabigatran etexilate, used to to prevent blood clots ketoconazole, itraconazole, posaconazole or voriconazole, used to treat fungal infections verapamil, diltiazem, nifedipine or amlodipine, used to decrease blood pressure rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin or pravastatin, used to lower blood cholesterol oral contraceptives
Maltese: Ittabib jaf ikun jeħtieġ iżid il-frekwenza tat-testijiet tad-demm tiegħek biex jiċċekkja kemm iddemm tiegħek jista' jagħqad sew. dabigatran etexilate, użat biex jevita l-emboli tad-demm ketoconazole, itraconazole, posaconazole jew voriconazole użati fil-kura ta' infezzjonijiet bilmoffa verapamil, diltiazem, nifedipine jew amlodipine, użati biex ibaxxu l-pressjoni tad-demm rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin jew pravastatin użati biex ibaxxu l
English: Among treatment-naïve patients with HCV RNA results at both follow-up Weeks 12 and 24, concordance between SVR12 and SVR24 was 99.5% independent of
Maltese: Fost pazjenti li ma ġewx ikkurati qabel ir-riżultati ta' HCV RNA fiż-żewġ Ġimgħat ta' segwiment, Ġimgħa 12 u Ġimgħa 24, il-konkordanza bejn SVR12 u SVR24 kienet 99.5% indipendentement mit-tul tal-kura.
English: Keep this leaflet.
Maltese: Hi rrakkomandata lattenzjoni.
English: Table 9: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 12 weeks, patients with cirrhosis or HCV recurrence after liver transplantation, Study ALLY-1
Maltese: Tabella 9: Riżultati tal-kura, daclatasvir f'kombinazzjoni ma' sofosbuvir u ribavirin għal 12il ġimgħa, pazjenti b'ċirrożi jew rikorrenza HCV wara trapjant tal-fwied, Studju ALLY-1
English: Discontinue Daklinza, peginterferon alfa and ribavirin Discontinue Daklinza, peginterferon alfa and ribavirin
Maltese: Azzjoni Ġimgħa ta' kura 4: >1,000 IU/mL Waqqaf Daklinza, peginterferon alfa u ribavirin
English: Among 258 patients who achieved SVR12 with daclatasvir and sofosbuvir (± ribavirin) with a median duration of post-SVR12 follow-up of 38 months, no relapses occurred (with relapses defined as confirmed or last available HCV RNA ≥ LLOQ).
Maltese: SVR12 ta' 38 xahar, ma seħħ lebda rkadar (b'rikaduti definiti bħala kkonfermati jew l-aħħar disponibbli HCV RNA ≥ LLOQ).
English: Missed doses
Maltese: FEJN MA
English: When Daklinza is used together with sofosbuvir (without ribavirin), the following side effects have
Maltese: Meta Daklinza jintuża flimkien ma' sofosbuvir (mingħajr ribavrin), ġew irrappurtati l-effetti
English: Table 15: Summary of noted newly emergent HCV NS5A substitutions on treatment or during follow-up in treated non-SVR12 subjects infected with HCV genotypes 1
Maltese: Sommarju ta' sostituzzjonijiet HCV NS5A li għadhom kif jiżviluppaw li ġew osservati fuq jew matul is-segwitu ta' individwi kkurati mingħajr SVR12 infettati b'HCV tal-ġenotipi 1 sa 3 Kategorija/ Sostituzzjoni, n
English: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Maltese: Każijiet ta' attivazzjoni mill-ġdid tal-virus tal-epatite B (HBV), xi wħud minnhom fatali, ġew irrappurtati matul jew wara trattament b'sustanzi antivirali li jaħdmu b'mod dirett.
English: Impact of baseline NS5A RAVs on cure rates
Maltese: L-impatt ta' NS5A RAVs fil-linja bażi fuq ir-rati tal-kura tal-infezzjoni ta'
English: CARDIOVASCULAR AGENTS Antiarrhythmics
Maltese: Kategorija farmakoterapewtika:
English: PK trough levels for peginterferon alfa in patients who received peginterferon alfa, ribavirin, and daclatasvir were received peginterferon alfa, ribavirin,
Maltese: L-ebda aġġustament fid-doża ta' Daklinza, peginterferon alfa, jew ribavirin mhu meħtieġ.
English: Table 4: Interactions and dose recommendations with other medicinal products Medicinal products by therapeutic areas
Maltese: Tabella 4: Interazzjonijiet u rakkomandazzjonijiet dwar id-doża ma' prodotti mediċinali oħra Prodotti mediċinali skont iżżoni terapewtiċi
English: Tel.: + 48 22 5796666
Maltese: Τηλ: + 30 210 6074300
English: Close monitoring is recommended if this medicinal product is administered with Daklinza in combination with sofosbuvir (see sections 4.4 and
Maltese: Huwa rrakkomandat monitoraġġ mill-qrib jekk dan il-prodott mediċinali jingħata ma' Daklinza flimkien ma' sofosbuvir (ara ssezzjonijiet 4.4 u 4.8).
English: All 3 HCV/HIV co
Maltese: Ġenotip 3 tal-HCV (ALLY-3)
English: For daclatasvirtreated patients with HCV RNA results at both follow-up Weeks 12 and 24, concordance of SVR12 and SVR24 was 97% for HCV genotype 1 and 100% for HCV genotype 4.
Maltese: Għal pazjenti b'HCV ittrattati b'daclatasvir riżultati ta' HCV RNA fiż-żewġ ġimgħat ta' segwiment, il-Ġimgħat 12 u 24, il-konkordanza ta' SVR12 u SVR 24 kienet 97% għal ġenotip 1 ta' HCV u 100%
English: migraine shortness of breath, cough, nasal congestion (blocked nose) hot flush dry skin, unusual hair loss or thinning, rash, itching diarrhoea, vomiting, abdominal pain, constipation, heartburn, excessive gas in the stomach or bowel dry mouth joint pain, aching or tender muscles, not caused by exercise
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): tnaqqis fl-aptit diffikultà biex torqod, irritabilità sturdament emigranja qtugħ ta' nifs, sogħla, konġestjoni fl-imnieħer (imnieħer misdud) ġilda xotta, telf ta' xagħar mhux tas-soltu jew ix-xagħar ma jibqax folt, raxx, ħakk dijarea, rimettar, uġigħ ta' żaqq, stitikezza, ħruq ta' stonku, gass żejjed fl-istonku jew fl-imsaren uġigħ fil-ġogi, uġigħ jew sensittività fil-muskoli, mhux ikkawżati mill-eżerċizzju Meta Daklinza jintuża flimkien ma' peginterferon alfa u ribavirin l-effetti sekondarji rrappurtati jkunu l-istess bħal dawk elenkati fil-fuljetti ta' tagħrif għal dawn il-mediċini.
English: In patients who received daclatasvir 60 mg tablet orally followed by 100 μg [
Maltese: F'pazjenti li rċivew pillola orali ta' daclatasvir 60 mg segwita minn doża ta' 100 μg ġol-vina ta'
English: 40 to 59
Maltese: 40 sa 59
English: Member State EU / EEA
Maltese: Stat Membru UE / ŻEE
English: 2 - 4, rue Lionel Terray 92500 Rueil-Malmaison France
Maltese: 2 - 4, rue Lionel Terray 92500 Rueil-Malmaison Franza
English: Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes 764.E-08013 Barcelona Spain
Maltese: Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes 764.E-08013 Barcelona Spanja
English: Famvir is an antiviral medicine.
Maltese: Famvir huwa mediċina antivirali.
English: Largo Umberto Boccioni 1 I-21040 Origgio Italy
Maltese: Largo Umberto Boccioni 1 I-21040 Origgio L-Italja
English: Several doses were investigated in pivotal studies (004, 011, 040).
Maltese: Diversi dożi ġew investigati fi studji pivotali (004, 011, 040).
English: Grünwalder Gesundheitsprodukte GmbH
Maltese: Il-Ġermanja Grünwalder Gesundheitsprodukte GmbH
English: Serious side effects of Famvir are:
Maltese: Effetti sekondarji gravi ta' Famvir huma:
English: 90429 Nürnberg Germany
Maltese: 90429 Nürnberg
English: A total of 1,587 patients have received famciclovir at recommended doses in placebo- (n=657) and active- (n=930) controlled studies.
Maltese: Total ta' 1,587 pazjent rċevew famciclovir skont id-dożi rrakkomandati fi plaċebo- (n=657) u fi studji attivi kkontrollati- (n=930).
English: Penciclovir triphosphate resembles deoxyguanosine triphosphate (dGTP), a component of DNA.
Maltese: Penciclovir trifosfat jixbaħ lil deoxyguanosine triphosphate (dGTP), komponent tad-DNA.
English: Box 23490 Nicosia
Maltese: Box 23490
English: Fertility
Maltese: Fertlità
English: Urticaria, serious skin reactions* (e.g. erythema multiforme, StevensJohnson Syndrome, Toxic Epidermal Necrolysis).
Maltese: Urtikarja, reazzjonijiet gravi fil-ġilda* (eż. eritrema multiformi, Sindromu ta' Stevens-Johnson, Nekrolożi Epidermali Tossika).
English: Elderly patients (≥ 65 years)
Maltese: Pazjenti anzjani(≥ 65 sena)
English: Novartis Hungaria Kft. Bartók Béla út 43-47 H-1114 Budapest Hungary
Maltese: L-Ungerija Novartis Hungaria Kft. Bartók Béla út 43-47
English: 2007; 44 (Suppl. 1): S1-26, Volpi A. Herpes 2007; 14 (Suppl. 2): 35A-39A).
Maltese: Herpes 2007; 14 (Suppliment 2): 35A-39A).
English: 183 11 Täby Sweden
Maltese: 183 11 Täby L-Isvezja
English: 12th Km National Road No. 1 GR-144 51 Metamorphosis Greece
Maltese: 1 GR-144 51 Metamorphosis
English: An article by (Strick, et al 2006) discussed the merits of suppressive versus episodic treatment of HSV in the HIV-infected patient.
Maltese: Artiklu minn (Strick, et al 2006) iddiskuta l-merti tat-trattamenti suppressivi kontra dawk episodiċi tal-HSV fil-pazjenti infettati bl-HIV.
English: Section 4.3: Contraindications
Maltese: Sezzjoni 4.3: Kontra-indikazzjonijiet
English: The deacetylation is catalyzed by the enzyme aldehyde oxidase.
Maltese: Id-deaċetilazzjoni hija kkatalizzata mill-enzima aldehyde oxidase.
English: Rash, pruritus.
Maltese: Raxx, prurite.
English: A recent publication, by Money B et al, supported the inclusion of this warning, which was endorsed by the CHMP.
Maltese: Pubblikazzjoni reċenti, ta' Money B et al, appoġġjat l-inklużjoni ta' din it-twissija, li ġiet approvata mis-CHMP.
English: • Raloxifen (used to prevent and treat osteoporosis).
Maltese: • Raloxifene (użat sabiex tipprevjeni u tikkura l-osteoporożi).
English: United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park
Maltese: Ir-Renju Unit Novartis Pharmaceuticals UK Ltd Frimley Business Park
English: Mean peak plasma concentration of penciclovir, following a 125 mg, 250 mg, 500 mg and 750 mg oral dose of famciclovir, was 0.8 microgram/ml, 1.6 micrograms/ml, 3.3 micrograms/ml and 5.1 micrograms/ml, respectively, and occurred at a median time of 45 minutes post-dose.
Maltese: Il-quċċata medja tal-konċentrazzjoni tal-plażma fil-penciclovir, wara li ngħatat doża orali ta' famciclovir ta' 125 mg, 250 mg, 500 mg u 750 mg, kienet ta' 0.8 mikrogrammi/ml, 1.6 mikrogrammi/ml, 3.3 mikrogrammi/ml u 5.1 mikrogrammi/ml, rispettivament, u seħħet f'ħin medju ta' 45 minuta wara li ngħatat id-doża.
English: It was noted that this dose is also in line with current literature recommendations (Dworkin RH et al, Clin.
Maltese: Ġie nnotat li din id-doża hija wkoll konformi mar-rakkomandazzjonijiet tal-letteratura attwali (Dworkin RH et al, Clin.
English: Several doses and regimens (bid, tid) were studied in different clinical trials.
Maltese: Diversi dożi u korsijiet (bid, tid) ġew studjati fi provi kliniċi differenti.
English: Section 4.1 Therapeutic indication
Maltese: Sezzjoni 4.1 Indikazzjoni terapewtika
English: Hypersensitivity to penciclovir.
Maltese: Sensittività eċċessiva għal penciclovir.
English: A total of 14 patients were withdrawn in Period 1 and 7 patients were withdrawn in Period 2.
Maltese: Total ta' 14-il pazjent ġew irtirati f'Perijodu 1 u 7 pazjenti ġew irtirati f'Perijodu 2.
English: 2100 Kopenhagen Ø Denmark
Maltese: Kopenhagen Ø Id-Danimarka