FrancophonIA/ELRC3.0 huggingface dataset:
English: Benign prostatic hypertrophy (BPH) is a natural consequence of ageing.
Maltese: Ipertrofija prostatika beninna (IPB) hi konsegwenza naturali ta' xjuħija.
English: YPOZANE 1.875 mg tablets for dogs YPOZANE 3.75 mg tablets for dogs YPOZANE 7.5 mg tablets for dogs YPOZANE 15 mg tablets for dogs
Maltese: Pilloli Ypozane 1.875 mg għall-klieb Pilloli Ypozane 3.75 mg għall-klieb Pilloli Ypozane 7.5 mg għall-klieb Pilloli Ypozane 15 mg għall-klieb
English: RELEASE
Maltese: Svezja
English: This might lead to multiple non-specific clinical signs such as abdominal pain, difficulties in defaecation and urination, blood in urine and locomotive disorders.
Maltese: Din tista twassal għal sinjali klinikali mhux speċifiċi multipli bħalluġigħ addominali, diffikultajiet fl-ippurgar u għemil ta' l-awrina, demm fl-urina u diżordnijiet lokomottivi.
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 1.875 mg osaterone acetate.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull pillola tikkuntieni 1.875 mg Osaterone acetate.
English: In dogs with BPH associated with prostatitis, the product can be administered concurrently with antimicrobials.
Maltese: Fi klieb b'IPB assoċjata ma' prostatite il-prodott jista' jiġi amministrat b'mod konkorrenti ma' antimikrobiċi.
English: Osaterone acetate is converted to its main, 15β-hydroxylated metabolite, which is also pharmacologically active.
Maltese: L-osaterone acetate hu konvertit fil-metabolita ewlenija tiegħu, 15β-hyrdoxylated metabolite, li hu wkoll farmakologikament attiv.
English: Osaterone acetate is a steroid chemically related to progesterone, and as such it has potent progestagen and potent anti-androgen activity.
Maltese: Osaterone acetate hu sterojdi relatat b'mod kimiku mal-proġesteron, u bħala tali għandu attività proġestaġen u attività anti-androġen qawwija.
English: Italia
Maltese: Italja
English: 4.9 Amounts to be administered and administration route
Maltese: .9 Kwantitajiet li għandhom jiġi amministrati u rotot ta' amministrazzjoni
English: Administer 0.25 - 0.5 mg osaterone acetate per kilogram bodyweight, once a day, for 7 days as follows:
Maltese: Amministra 0.25 - 0.5 mg osaterone acetate għal kull kilogramm ta' piż tal-ġisem, darba kuljum, għal 7 ijiem kif imsemmi hawn taħt:
English: After repeated administration of osaterone acetate at 0.25 mg/kg/day for 7 days, the factor of accumulation is about 34 without change in the rates of absorption or elimination.
Maltese: Wara amministrazzjoni ripetittiva ta' osaterone acetate ta' 0.25 mg/kg/ġurnata għal 7 ijiem, il-fattur ta' akkumulazzjoni hu madwar 3-4 mingħajr tibdiliet fir-rati ta' assorbiment jew eliminazzjoni.
English: Dogs (male)
Maltese: TWISSIJA(IJIET)
English: Magnesium stearate
Maltese: Stearat tal-manjesju
English: An overdose study (up to 1.25 mg/kg bodyweight for 10 days, repeated one month later) did not show undesirable effects except for a decrease of cortisol plasma concentration.
Maltese: Studju ta' doża eċċessiva (sa 1.25 mg għal kull kg ta' piż tal-ġisem għal 10 ijiem, ripetuta xahar wara) ma weriex effetti ħżiena ħlief nuqqas fil-konċentrazzjoni tal-plażma kortisol.
English: SPECIAL WARNING(S)
Maltese: INDIKAZZJONI(IJIET)
English: Pharmacotherapeutic group: drugs used in benign prostatic hypertrophy.
Maltese: Grupp farmakoterapewtiku: drogi wżati f'ipertrofija prostatika beninna.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 3.75 mg tablets for dogs Osaterone acetate
Maltese: VETERINARJU Pilloli Ypozane 3.75 mg għall-klieb Osaterone acetate
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 3.75 mg osaterone acetate
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull pillola tikkuntieni 3.75 mg osaterone acetate
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 7.5 mg osaterone acetate
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull pillola tikkuntieni 7.5 mg osaterone acetate.
English: Osaterone acetate inhibits the effects of an excess of male hormone (testosterone) through various mechanisms.
Maltese: Osaterone acetate jimpedixxi l-effetti mhux mixtieqa ta' eċċess ta' l-ormon maskil (testosterone) b'mekkaniżmi.diversi.
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 15 mg osaterone acetate
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull pillola tikkuntieni 15 mg osaterone acetate.
English: Osaterone is eliminated within 14 days, mainly in faeces via biliary excretion (60%) and to a lesser extent (25%) in urine.
Maltese: L-osaterone jiġi eliminat fi żmien erbatax-il ġurnata, il-biċċa l-kbira fl-ippurgar permezz ta' lekskrezzjoni tal-bile (60%) u fuq livell inqas (25%) fl-awrina.
English: No adverse effects on semen quality have been observed.
Maltese: Ma kien hemm l-ebda effett avvers osservat fil-kwalità tas-semen.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 1.875 mg tablets for dogs Osaterone acetate
Maltese: TAL-PRODOTT MEDIKU VETERINARJU Pilloli Ypozane 1.875 mg għall-klieb Osaterone acetate
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Maltese: Staqsi lill-kirurgu veterinarju tiegħek kif għandek tarmi mediċini li m'għandekx bżonn iżjed.
English: Lactose monohydrate
Maltese: Lattosju monoidrat Lamtu preġelatiniżżat
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 1.875 mg
Maltese: MINIMI LI GĦANDHOM JIDHRU FUQ IL-VIŻIKANT VIŻIKANT - 1.875 mg
English: BPH is a development and enlargement of the prostate due to the male hormone testosterone.
Maltese: IPB hi żvilupp u tkabbir tal-prostata minħabba l-ormon maskili testosterone.
English: Name and address of the manufacturer responsible for batch release Virbac S.A.
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ f'lottijiet Virbac S.A.
English: 4.2 Indications for use, specifying the target species
Maltese: .2 Indikazzjonijiet għall-użu, speċifika ta' l-ispeċi targittati
English: Do not use after the expiry date stated on the blister after “EXP”
Maltese: Tużax wara d-data ta' għeluq indikata fuq il-viżikant wara “EXP” 12.
English: If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary.
Maltese: Jekk irreazzjoni klinika għat-trattament hi konsiderevolment iqsar milli mistenni, rievalwazzjoni tad-dijanjosi hi meħtieġa.
English: A transient reduction of plasma cortisol concentration may occur; this may continue for several weeks after administration.
Maltese: Riduzzjoni transitorja ta' konċentrazzjoni ta' plażma kortisol tista' sseħħ; din tista' tkompli għal diversi ġimgħat wara l-amministrazzjoni.
English: *No data are available for dogs less than 3 kg bodyweight
Maltese: *M'hemmx informazzjoni disponibbli għall-klieb ta' inqas minn 3 kg fil-piż tal-ġisem
English: Suomi/Finland VIRBAC S.A. 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
Maltese: Suomi/Finlandja VIRBAC S.A. 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
English: Number of tablet per day
Maltese: Numru ta' pilloli filġurnata
English: Dogs.
Maltese: PARTIKULARI
English: Treatment of benign prostatic hypertrophy (BPH) in male dogs.
Maltese: Trattament ta' ipertrofija prostatika beninna (IPB) fil-klieb ta' sess maskili.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 15 mg tablets for dogs Osaterone acetate
Maltese: TAL-PRODOTT MEDIKALI VETERINARJU Pilloli Ypozane 15 mg għall-klieb
English: - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effett(i) mhux mixtieq(a) matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: PACKAGE LEAFLET
Maltese: SPEĊI TARGITTATI
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 7.5 mg
Maltese: MINIMI LI GĦANDHOM JIDHRU FUQ IL-VIŻIKANTI VIŻIKANT - 7.5 mg
English: Slovenija VIRBAC S.A. 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
Maltese: Slovenja VIRBAC S.A. 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
English: Treatment of benign prostatic hypertrophy in male dogs.
Maltese: Trattament ta' ipertrofija prostatika beninna fil-klieb ta' sess maskili.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/002
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦALL-BEJGĦ EU/2/06/068/002
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 7.5 mg tablets for dogs Osaterone acetate
Maltese: TAL-PRODOTT MEDIKALI VETERINARJU Pilloli Ypozane 7.5 mg għall-klieb
English: Česká republika VIRBAC S.A. 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
Maltese: Repubblika Čeka VIRBAC S.A. 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/003
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦALL-BEJGĦ EU/2/06/068/003
English: The response to an ACTH stimulation test may also be suppressed for several weeks after administration of osaterone.
Maltese: Ir-reazzjoni ta' eżami ta' stimulazzjoni ACTH tista' tkun issopprimata għal diversi ġimgħat wara l-amministrazzjoni ta' osaterone.
English: Magyarország VIRBAC S.A. 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
Maltese: Ungerija VIRBAC S.A. 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
English: Systemic fungal infections.
Maltese: Infezzjonijiet fungali sistemiċi.
English: • Malassezia folliculitis
Maltese: • Malassezia follikulite
English: Of note, while ketoconazole was available since 1982, fluconazole and itraconazole became later available in the 1990's.
Maltese: Ta' min jinnota li, filwaqt li ketoconazole ilu disponibbli mill-1982, fluconazole u itraconazole saru disponibbli aktar tard fl-1990s.
English: Efficacy studies of ketoconazole on Malassezia folliculitis, Pityriasis versicolor, Tinea Capitis and Tinea Barbae, Tinea Corporis, Tinea Cruris, Tinea Pedis, and Tinea Manuum were scarce.
Maltese: L-istudji dwar l-effikaċja ta' ketoconazole fuq Malassezia follikulite, Pityriasis versicolor, Tinea Capitis u Tinea Barbae, Tinea Corporis, Tinea Cruris, Tinea Pedis, u Tinea Manuum kienu skarsi.
English: In parallel, on 1 July 2011, France triggered a referral under Article 31of Directive 2001/83/EC, as amended.
Maltese: B'mod parallel, fl-1 ta' Lulju 2011, Franza bdiet riferiment skont l-Artikolu 31 tadDirettiva 2001/83/KE, kif emendata.
English: All but 5 tinea capitis (no case of Malassezia folliculitis) corresponded to Chronic Mucocutaneous Candidiasis (n=16).
Maltese: Malassezia follikulite) kienu jikkorrispondu għal Kandidijasi Mukokutanja Kronika (n=16).
English: Of the 1,505 cases of interest; 880 (58%) were medically validated serious of which 18 life-threatening cases did not present any confounding factors and therefore are supportive of a causal role of ketoconazole.
Maltese: Mill-1,505 każijiet ta' interess; 880 (58%) kienu medikament validati bħala serji li minnhom 18-il każ ta' periklu għall-ħajja ma ppreżentaw l-ebda fattur ta' tfixkil u għalhekk jappoġġaw rwol kawżali ta' ketoconazole.
English: • Histoplasmosis
Maltese: • Istoplasmosi
English: • Blastomycosis
Maltese: • Blastomikożi
English: Ketoconazole 20mg/ml oral suspension and ketoconazole 100mg tablet formulations are no longer authorised in any EEA Member State.
Maltese: Il-formulazzjonijiet ta' ketoconazole 20mg/ml suspensjoni orali u ketoconazole 100mg pillola ma għadhom awtorizzati fl-ebda Stat Membru taż-ŻEE.
English: • Chronic mucocutaneous candidosis
Maltese: • Kandidożi mukokutanja kronika
English: Ketoconazole does not penetrate well in the Central Nervous System.
Maltese: Ketoconazole ma jippenetrax tajjeb fis-Sistema Nervuża Ċentrali.
English: Ketoconazole was first registered as tablets and oral suspension in December 1980.
Maltese: Ketoconazole għall-ewwel kien irreġistrat bħala pilloli u suspensjoni orali f'Diċembru 1980.
English: In the literature, incidence of acute injuries is variable and ranged from 1/2000 patients exposed to 12%.
Maltese: Fil-letteratura, l-inċidenza ta' korrimenti akuti hija varjabbli u kienet tvarja minn 1/2000 pazjent espost sa 12%.
English: A cumulative search through 15 July 2011 for adverse events coded to the MedDRA (version 14.0) Preferred Terms (PTs) listed in the Standardised MedDRA Queries (SMQ) Hepatic disorders (broad terms) retrieved 1,512 cases, of which 1,505 cases were part of the sub-SMQ Drug related hepatic disorders (comprehensive search excluding non-drug related events such as congenital, infection, alcohol and pregnancy related events).
Maltese: Tfittxija kumulattiva sal-15 ta' Lulju 2011 għal avvenimenti avversi kodifikati skont it-Termini Preferiti (PTs) fid-database MedDRA (verżjoni 14.0) elenkati fit-Tfittxijiet Standardizzati tal-MedDRA (SMQ) Disturbi epatiċi (termini ġenerali) sabet 1,512-il każ, li 1,505 minnhom kienu parti mis-sub-SMQ ‘Disturbi epatiċi relatati mal-mediċina' (tfittxija komprensiva li teskludi avvenimenti mhux relatati malmediċina bħal avvenimenti konġenitali, ta' infezzjoni, alkoħol u relatati mat-tqala).
English: Treatment duration ranges from 5 consecutive days (vaginal candidosis) to up to 6 months for systemic fungal infections such as paracoccidioidomycosis and histoplasmosis.
Maltese: It-tul tal-kura jvarja minn 5 ijiem konsekuttivi (kandidożi vaġinali) sa anki 6 xhur għal infezzjonijiet fungali sistemiċi bħall-paracoccidioidomycosis u l-istoplasmosi.
English: The potential for hepatotoxicity is a class effect of azole antifungals and has been long reported for ketoconazole in numerous nonclinical and clinical references.
Maltese: Il-potenzjal ta' epatotossiċità huwa effett tal-kategorija tal-antifungali azole u ilu rrapportat għal ketoconazole f'bosta referenzi mhux kliniċi u kliniċi.
English: From 1985 to 2010, around a hundred cases of hepatic disorders with oral ketoconazole were reported to the French Pharmacovigilance Regional Centres network, including hepatitis NOS, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, hepatic failure.
Maltese: Mill-1985 sal-2010, kienu rrapportati madwar mitt każ ta' disturbi tal-fwied b'ketoconazole orali linnetwerk Franċiż ta' Ċentri Reġjonali tal-Farmakoviġilanza, li kienu jinkludu epatite NOS, epatite tossika, epatite ċitolitika, epatite kolestatika, insuffiċjenza tal-fwied.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ketoconazole-containing products for oral use;
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal prodotti li fihom ketoconazole għall-użu orali;
English: The incidence of symptomatic hepatic reactions in the setting of treatment with oral ketoconazole was estimated in several epidemiology studies to be between 1/10,000 and 1/15,000 patients.
Maltese: L-inċidenza tar-reazzjonijiet epatiċi sintomatiċi fl-ambitu tal-kura b'ketoconazole orali kienet stmata f'diversi studji epidemjoloġiċi bejn 1/10,000 u 1/15,000 pazjent.
English: The marketing authorisation holder extensively discussed the mechanism of hepatotoxicity, widely supported with literature data from 1986 to 2007.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq iddiskuta estensivament ilmekkaniżmu tal-epatotossiċità, appoġġat b'mod estensiv b'dejta mil-letteratura mill-1986 sal-2007.
English: The clinical safety of oral ketoconazole was evaluated in 4735 subjects in 92 company-sponsored clinical trials of ketoconazole tablets (or suspension), administered either to treat a variety of fungal infections in patients or to healthy-volunteer subjects.
Maltese: Is-sigurtà klinika ta' ketoconazole orali kienet evalwata f'4735 individwu fi 92 prova klinika sponsorjati mill-kumpanija, tal-pilloli ketoconazole (jew suspensjoni), mogħti jew għall-kura ta' varjetà ta' infezzjonijiet fungali f'pazjenti jew lil voluntiera b'saħħithom.
English: Based on this analysis, the point-estimate risk, in terms of the commonly-used Frequency Categories in the Summary of Product Characteristics (SmPCs), was “Common” (≥ 1/100 to < 1/10) for any Hepatic Function Test result being abnormal, and “Rare” (≥ 1/10,000 to < 1/1,000) for Hepatitis and/or Jaundice.
Maltese: Abbażi ta' din l-analiżi, l-istima tar-riskju, f'termini tal-Kategoriji ta' Frekwenza użati b'mod komuni fis-Sommarju tal-Karatteristiċi tal-Prodott (SmPCs), kienet “Komuni” (≥ 1/100 sa < 1/10) għal kwalunkwe riżultat ta' Test tal-Funzjoni tal-Fwied li jkun abnormali, u “Rari” (≥ 1/10,000 sa < 1/1,000) għall-Epatite u/jew is-Suffejra.
English: • Orapharyngeal and esophageal candidosis
Maltese: • Kandidożi orofaringali u esofagali
English: The SAG was also of the opinion that the pharmacokinetics / pharmacodynamics profile of ketoconazole presents similar limitations as the other systemic antifungal treatments (i.e. limited absorption, distribution) and the drug-drug interaction profile could be even worse.
Maltese: L-SAG kien tal-opinjoni wkoll li l-profil farmakokinetiku / farmakodinamiku ta' ketoconazole jippreżenta limitazzjonijiet simili għat-tipi ta' kura antifungali sistemiċi l-oħra (jiġifieri assorbiment, distribuzzjoni limitati) u l-profil tal-interazzjoni bejn il-mediċini jista' jkun saħansitra agħar.
English: In order to assess the general safety of ketoconazole, relevant information from pre-clinical studies, clinical trials, post-marketing spontaneous case reports, pharmaco-epidemiological studies and published literature was assessed.
Maltese: Sabiex tiġi valutata s-sigurtà ġenerali ta' ketoconazole, kienet valutata informazzjoni rilevanti minn provi prekliniċi, provi kliniċi, rapporti ta' każijiet spontanji wara t-tqegħid fis-suq, studji farmakoepidemjoloġiċi u l-letteratura ppubblikata.
English: The benefits and the risks of oral ketoconazole in dermatophytosis (Tinea Capitis, Tinea Barbae, Tinea Corporis, Tinea Cruris, Tinea Pedis, and Tinea Manuum) Pityriasis Versicolor, Malassezia folliculitis, Infections Due to Candida Species, Cutaneous candidiasis, Chronic Mucocutaneous Candidosis, Oropharyngeal Candidosis, Oesophageal Candidosis, Chronic Recurrent Vulvovaginal Candidosis, Systemic Mycoses (Paracoccidioidomycosis, Histoplasmosis, Coccidioidomycosis, Blastomycosis) were reviewed by the MAH which concluded that ketoconazole had an acceptable safety profile when used at low dose for short periods in benign diseases, but that its use at high doses for extended periods could only be supported where there was good efficacy and the risks of hepatotoxicity were outweighed by the mortality and serious morbidity of the disease.
Maltese: Il-benefiċċji u r-riskji ta' ketoconazole orali f'dermatofitosi (Tinea Capitis, Tinea Barbae, Tinea Corporis, Tinea Cruris, Tinea Pedis, u Tinea Manuum) Pityriasis Versicolor, Malassezia follikulite, Infezzjonijiet minħabba Speċijiet ta' Candida, Kandidijasi tal-ġilda, Kandidożi Mukokutanja Kronika, Kandidożi Orofaringali, Kandidożi Esofagali, Kandidożi Vulvovaġinali
English: Annex II Scientific conclusions and grounds for suspension of the marketing authorisations
Maltese: Anness II Konklużjonijiet xjentifiċi u raġunijiet għas-sospensjoni talawtorizzazzjonijiet għat-tqegħid fis-suq
English: - hepatotoxicity with ketoconazole has been reported at a daily dose of 200 mg (median) which is the recommended daily dose; - the incidence and seriousness of hepatotoxicity associated with the use of oral ketoconazole is higher than with the use of other antifungals in the treatment of superficial, sub-cutaneous and systemic fungal infections, with the highest crude incidence rate per 10 000 patients for acute liver injury among other oral antifungals and with its use associated with the development of chronic hepatitis and cirrhosis (Chien et al, 1997; Garcia et al, 1999); - the onset of hepatotoxicity with ketoconazole usually occurs between 1 and 6 months after initiation of treatment (55% of the cases when the time to onset was documented) but has also be reported earlier than 1 month (including few days) after initiation of treatment (35% of the cases when the time to onset was documented);
Maltese: Garcia et al, 1999); - il-bidu tal-epatotossiċità b'ketoconazole ġeneralment iseħħ bejn 1 u 6 xhur wara l-bidu tal-kura (55% tal-każijiet meta ġie dokumentat iż-żmien sal-bidu) iżda ġie rrapportat ukoll aktar kmieni minn xahar (inkluż ftit ġranet) wara l-bidu tal-kura (35% tal-każijiet meta ġie dokumentat iż-żmien sal-bidu); Ġie konkluż li r-riżultati tal-analiżi attwali tal-każijiet kollha ta' epatotossiċità potenzjali bi prodotti mediċinali li fihom ketoconazole orali jikkonfermaw ir-riskju ta' epatotossiċità serja assoċjata mal-użu ta' ketoconazole orali, li ntwera l-aħjar mill-valutazzjonijiet tal-kawżalità tal-każijiet ta' epatotossiċità fatali/ta' periklu għall-ħajja.
English: At the request of the CHMP, an Anti-Infective Scientific Advisory group (SAG) meeting was held on 3 September 2012.
Maltese: Fuq talba tas-CHMP, fit-3 ta' Settembru 2012 saret laqgħa tal-Grupp Konsultattiv Xjentifiku dwar lAnti-Infettivi.
English: • Chronic, recurrent vaginal candidosis
Maltese: • Kandidożi vaġinali kronika rikorrenti
English: Results from non-clinical toxicity studies indicated the liver and endocrine system as primary target organs.
Maltese: Ir-riżultati minn studji mhux kliniċi dwar it-tossiċità indikaw il-fwied u s-sistema endokrinarja bħala lorgani primarji fil-mira.
English: The therapeutic indications included in the current version of the Company Core Data Sheet (CCDS) of the originator product are as follows:
Maltese: L-indikazzjonijiet terapewtiċi inklużi fl-Iskeda tad-Dejta Ewlenija tal-Kumpanija (CCDS) talprodott oriġinatur huma kif ġejjin:
English: The experts unanimously agreed that there was no scientific evidence to support the MAH's revised indication proposal.
Maltese: L-esperti qablu b'mod unanimu li ma kien hemm ebda evidenza xjentifika li tappoġġa l-proposta tad-detentur talawtorizzazzjoni għat-tqegħid fis-suq għal indikazzjoni riveduta.
English: In 2011, a review performed by the French National Competent Authority concluded that spontaneous reports and literature data indicate that oral ketoconazole is associated with a high level of liver toxicity.
Maltese: Fl-2011, valutazzjoni mwettqa mill-Awtorità Nazzjonali Kompetenti Franċiża kkonkludiet li r-rapporti spontanji u d-dejta mil-letteratura jindikaw li ketoconazole orali huwa assoċjat ma' livell għoli ta' tossiċità tal-fwied.
English: • Cutaneous candidosis
Maltese: • Dermatofitosi
English: Amongst other risk minimisation activities proposed by the MAH were the restriction of prescribing by physicians experienced in treating rare fungal skin disease and rare sub-sets of common fungal disease, Limitation of the use: short treatment periods and treatment of susceptible infecting pathogens only (Candida) and enhanced communication on the risks.
Maltese: Fost attivitajiet oħra ta' minimizzazzjoni tar-riskju proposti mid-detentur tal-awtorizzazzjoni għattqegħid fis-suq kien hemm ir-restrizzjoni tal-preskrizzjoni minn tobba bl-esperjenza fil-kura ta' mard fungali rari tal-ġilda u sottosettijiet rari ta' mard fungali komuni, il-limitazzjoni tal-użu: perjodi qosra ta' kura u l-kura ta' patoġeni infettivi suxxettibbli biss (Candida) u komunikazzjoni aħjar dwar ir-riskji.
English: In children, dosing recommendations are also broadly consistent with 100 mg daily for children weighing 15-30 kg and the same dose as for adults in children weighing more than 30 kg.
Maltese: Fit-tfal, ir-rakkomandazzjonijiet dwar id-doża huma wkoll ġeneralment konsistenti, b'100 mg għat-tfal li jiżnu 15-30 kg u l-istess doża bħal tal-adulti fit-tfal li jiżnu aktar minn 30 kg.
English: Overall, although hepatotoxicity is a class effect of azoles, the quantitative and qualitative aspects of the hepatotoxicity of ketoconazole are of particular concern.
Maltese: B'mod ġenerali, għalkemm l-epatotossiċità hija effett tal-kategorija tal-azoles, l-aspetti kwantitattivi u kwalitattivi tal-epatotossiċità ta' ketoconazole huma ta' tħassib partikolari.