FrancophonIA/ELRC3.0 huggingface dataset:
English: Difference in proportions and the 95% confidence interval (CI)
Maltese: Differenza fil-proporzjonijiet u l-intervall ta' kunfidenza ta' 95% (CI)
English: Incompatibilities:
Maltese: Inkompatibbiltajiet:
English: Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença 2705-906 Terrugem SNT Portugal
Maltese: Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença 2705-906 Terrugem SNT Portugall
English: Dosage adjustment (Adults)
Maltese: Aġġustament tad-doża (Adulti)
English: Anticoagulants
Maltese: Antikoagulaneti
English: Oral*
Maltese: Orali*
English: Low dose (100 mg BID)*
Maltese: Doża baxxa (100 mg BID)*
English: • Phototoxicity
Maltese: • Fototossiċità
English: 8 See section 4.4.
Maltese: Ara sezzjoni 4.4. 8 Ara sezzjoni 4.4.
English: P-Value
Maltese: Valur P
English: Other Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.g., delavirdine, nevirapine)*
Maltese: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) oħra (eż. delavirdine, nevirapine)*
English: Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UK
Maltese: Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW Ir-Renju Unit
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {27 May 2015}
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 Mejju 2015
English: pH of the reconstituted solution is 4.0 to 7.0.
Maltese: Il-pH tas-soluzzjoni rikostitwita hi 4.0 sa 7.0.
English: Voriconazole Hikma is an antifungal medicine.
Maltese: Voriconazole Hikma huwa mediċina antifungali.
English: Packs of 1 or 5 vials.
Maltese: Pakketti ta' kunjett 1 jew 5.
English: • Abnormal electrocardiogram (ECG)
Maltese: • Elettrokardjogramm (ECG) anormali
English: Digoxin (0.25 mg QD) [P-gp substrate]
Maltese: Digoxin (0.25 mg QD) [sottostrat ta' P-gp]
English: • invasive aspergillosis (a type of fungal infection due to Aspergillus sp.),
Maltese: • aspergillosis invażiva (tip ta' infezzjoni fungali b'Aspergillus sp),
English: R-methadone (active) Cmax ↑ 31% R-methadone (active) AUCτ ↑ S-methadone Cmax ↑ 65% S-methadone AUCτ ↑ 103%
Maltese: R-methadone (active) AUCτ ↑ 47% S-methadone Cmax ↑ 65% S-methadone AUCτ ↑ 103%
English: Astemizole, cisapride, pimozide, quinidine and terfenadine [CYP3A4 substrates]
Maltese: Astemizole, cisapride, pimozide, quinidine u terfenadine [sottostrati ta' CYP3A4]
English: Macrolide antibiotics Erythromycin (1 g BID) [CYP3A4 inhibitor] Azithromycin (500 mg QD)
Maltese: Antibijotiċi Makrolide Erythromycin (1 g BID) [inibitur ta' CYP3A4] Azithromycin (500 mg QD)
English: Mycophenolic acid (1 g single dose) [UDP-glucuronyl transferase substrate]
Maltese: Mycophenolic acid (doża waħda ta' 1 g) [sottostrat ta' UDP-glucuronyl transferase]
English: Patients less than 40 kg**
Maltese: minn 40 kg**
English: Not studied clinically.
Maltese: Mhux studjat klinikament.
English: and Sporothrix spp.
Maltese: u Sporothrix spp.
English: 6 See “Visual impairments” paragraph in section 4.8.
Maltese: 6 Ara l-paragrafu “Indebolimenti viżwali” fis-sezzjoni 4.8.
English: Norethisterone/ethinylestradiol (1 mg/0.035 mg QD)
Maltese: Norethisterone/ethinylestradiol (1 mg/0.
English: • St John's Wort (herbal supplement)
Maltese: St John's Wort (fexfiex)
English: Frequency categories are expressed as: 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 rare (<1/10,000); Not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10; Komuni (≥1/100 u <1/10); Mhux komuni (≥1/1,000 u <1/100); Rari (≥1/10,000 u <1/1,000);
English: Uncommon ≥ 1/1,000 to <
Maltese: Mhux komuni ≥ 1/1,000 sa <
English: In an independent published study, Voriconazole AUC0-∞ ↓ 59%
Maltese: Fi studju indipendenti ppubblikat, Voriconazole AUC0-∞ ↓ 59%
English: In an independent published study, Oxycodone Cmax ↑ 1.7-fold Oxycodone AUC0-∞ ↑ 3.6-fold
Maltese: Fi studju indipendenti ppubblikat, Oxycodone Cmax ↑ 1.7 darbiet Oxycodone AUC0-∞ ↑ 3.6 darbiet
English: Stability after dilution:
Maltese: Stabilità wara d-dilwazzjoni:
English: Compared to efavirenz 600 mg QD,
Maltese: Ikkomparat ma' efavirenz 600 mg QD,
English: Sulfonylureas (e.g., tolbutamide, glipizide, glyburide) [CYP2C9 substrates]
Maltese: Sulfonylureas (eż. tolbutamide, glipizide, glyburide) [sottostrati ta' CYP2C9]
English: Benzodiazepines (e.g., midazolam, triazolam, alprazolam) [CYP3A4 substrates]
Maltese: Benzodiazepines (eż., midazolam, triazolam, alprazolam) [sottostrati ta' CYP3A4]
English: • Astemizole (used for allergy)
Maltese: • Astemizole (użat għal allerġija)
English: EU/1/15/1004/001 1 Pack EU/1/15/1004/002 5 Pack
Maltese: EU/1/15/1004/002 pakkett ta' 5
English: Rifabutin Cmax ↑ 195% Rifabutin AUCτ ↑ 331% Compared to voriconazole 200 mg BID,
Maltese: Rifabutin Cmax ↑ 195% Rifabutin AUCτ ↑ 331% Ikkomparat ma' voriconazole 200 mg BID,
English: Respiratory, thoracic and mediastinal disorders respiratory distress9
Maltese: Disturbi respiratorji, toraċiċi u medjastinali disturb respiratorju9
English: 2 Includes immune thrombocytopenic purpura.
Maltese: 2 Tinkludi purpura tromboċitopenika immuni.
English: acute respiratory distress syndrome, pulmonary oedema
Maltese: sindromu ta' dieqa akuta respiratorja, edima pulmonari
English: Insufficient evidence
Maltese: Evidenza insuffiċjenti
English: Hikma Italia S.p.A. Tél/Tel: + 39 0382 1751801
Maltese: Tél/Tel: + 39 0382 1751801
English: Rifampicin (600 mg QD) [potent CYP450 inducer]
Maltese: Rifampicin (600 mg QD) [induttur qawwi ta' CYP450]
English: Fusarium spp.
Maltese: u Fusarium spp.
English: Immunosuppressants [CYP3A4 substrates] Sirolimus (2 mg single dose)
Maltese: Immunosoppressanti [sottostrati ta' CYP3A4] Sirolimus (doża waħda ta' 2 mg)
English: Efavirenz (a non-nucleoside reverse transcriptase inhibitor) [CYP450 inducer; CYP3A4 inhibitor and substrate] Efavirenz 400 mg QD, coadministered with voriconazole 200 mg BID*
Maltese: Efavirenz (inibitur ta' nonnucleoside reverse transcriptase) [induttur ta' CYP450; induttur u sottostrat ta' CYP3A4] Efavirenz 400 mg QD, li jingħata flimkien ma' voriconazole 200 mg BID*
English: General pharmacokinetic characteristics
Maltese: Karatteristiċi farmakokinetiċi ġenerali
English: Voriconazole is a triazole antifungal agent.
Maltese: Voriconazole huwa aġent antifungali tat-tip triazole.
English: Statins (e.g., lovastatin) [CYP3A4 substrates]
Maltese: Statins (eż. lovastatin) [sottostrati ta' CYP3A4]
English: Multiple intravenous doses of 3, 4, 6, 7 and 8 mg/kg twice daily and multiple oral doses (using the powder for oral suspension) of 4 mg/kg, 6 mg/kg, and 200 mg twice daily were evaluated in 3 paediatric pharmacokinetic studies.
Maltese: Dożi multipli fil-vina ta' 3, 4, 6, 7 u 8 mg/kg darbtejn kuljum u dożi multipli orali (bl-użu tat-trab għas-suspensjoni orali) ta' 4 mg/kg, 6 mg/kg, u 200 mg darbtejn kuljum kienu evalwati fi 3 studji farmakokinetiċi f'pazjenti tfal.
English: The placeboadjusted mean maximum increases in QTc from baseline after 800, 1200 and 1600 mg of voriconazole were 5.1, 4.8, and 8.2 msec, respectively and 7.0 msec for ketoconazole 800 mg. No subject in any group had an increase in QTc of ≥60 msec from baseline.
Maltese: Iż-żidiet massimi medji aġġustati bil-plaċebo fil-QTc mil -linja bażika wara 800, 1200 u 1600 mg ta' voriconazole kienu 5.1, 4.8, u 8.2 msec, rispettivament u 7.0 msec għal ketoconazole 800 mg.
English: • Ergot alkaloids (e.g., ergotamine, dihydroergotamine; used for migraine)
Maltese: • Alkalojdi tal-ergotina (eż., ergotamine, dihydroergotamine; użati għall-emigranja)
English: • Terfenadine (used for allergy)
Maltese: • Terfenadine (użat għal allerġija)
English: • Fluconazole (used for treating fungal infections)
Maltese: • Fluconazole (użat għal infezzjonijiet fungali)
English: Adults
Maltese: Trattament Adulti
English: Not for bolus injection.
Maltese: Mhux għal injezzjoni bolus.
English: There is limited data on the safety of voriconazole in patients with abnormal liver function tests (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), or total bilirubin >5 times the upper limit of normal).
Maltese: Hemm dejta limitata dwar is-sigurtà ta' voriconazole f'pazjenti b'testijiet tal-funzjoni tal-fwied mhux normali (aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], jew bilirubin totali >5 darbiet il-limitu ta' fuq tan-normal).
English: Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) [CYP2C9 substrates] Ibuprofen (400 mg single dose)
Maltese: Mediċini anti-infjammatorji mhux sterojdi (non-steroidal antiinfiammatory Drugs, NSAIDs) [sottostrati ta' CYP2C9] Ibuprofen (doża waħda ta' 400 mg)
English: In an independent published study, Sirolimus Cmax ↑ 6.6-fold Sirolimus AUC0-∞ ↑ 11-fold
Maltese: Fi studju indipendenti ppubblikat, Sirolimus Cmax ↑ 6.6-darbiet Sirolimus AUC0-∞ ↑ 11-il darba
English: • Statins (e.g., atorvastatin, simvastatin) (used for lowering cholesterol)
Maltese: • Statins (eż. atorvastatin, simvastatin) (użati biex ibaxxu l-kolesterol)
English: In vitro, voriconazole displays broad-spectrum antifungal activity with antifungal potency against Candida species (including fluconazole resistant C. krusei and resistant strains of C. glabrata and C. albicans) and fungicidal activity against all Aspergillus species tested.
Maltese: In vitro, voriconazole juri attività antifungali ta' spettru wiesgħa b'qawwa antifungali kontra speċi Candida (fosthom C. krusei reżistenti għal fluconazole u forom reżistenti ta' C. glabrata u C. albicans) u attività funġiċida kontra l-ispeċi Aspergillus kollha ttestjati.
English: In an independent published study, Alfentanil AUC∞ ↑ 6-fold
Maltese: Alfentanil AUC∞ ↑ 6 darbiet
English: • Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
Maltese: • Kura ta' infezzjonijiet invażivi serji Candida reżistenti għal fluconazole (fosthom C. krusei).
English: • Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac) (used for treating pain and inflammation)
Maltese: • Mediċini anti-infjammatorji mhux sterojdi (eż. ibuprofen, diclofenac) (użati kontra l-uġigħ u infjammazzjoni)
English: Serious dermatological adverse reactions
Maltese: Reazzjonijiet avversi dermatoloġiċi serji
English: The survival rate at Day 180 was 80.0% (32/40) and at 1 year was 70.0% (28/40).
Maltese: Ir-rata ta' sopravivenza f'Jum 180 kienet ta' 80% (32/40) u mas-sena kienet 70.0% (28/40).
English: Compared to voriconazole 200 mg BID,
Maltese: Ikkomparat ma' voriconazole 200 mg BID,
English: In 10 therapeutic studies, the median for the average and maximum plasma concentrations in individual subjects across the studies was 2425 ng/ml (inter-quartile range 1193 to 4380 ng/ml) and 3742 ng/ml (interquartile range 2027 to 6302 ng/ml), respectively.
Maltese: F'10 studji terapewtiċi, il-punt medjan għal konċentrazzjonijiet medji u massimi fil-plasma f'suġġetti individwali madwar l-istudji kien 2425 ng/ml (medda inter -quartile 1193 sa 4380 ng/ml) u 3742 ng/ml (medda inter-quartile 2027 sa 6302 ng/ml), rispettivament.
English: The overall rate of response (ICC and EC combined) was 88.9% (8/9) for 2 to <12 years old and 62.5% (5/8) for 12 to <18 years old.
Maltese: Ir-rata ta' rispons globali (ICC u EC flimkien) kienet 88.9% (8/9) għal pazjenti li kellhom minn sentejn sa <12-il sena u 62.5% (5/8) għal pazjenti li kellhom minn 12 sa <18-il sena.
English: • Rifabutin (used for treating tuberculosis).
Maltese: • Rifabutin (użat għall-kura tat-tuberkulosi).
English: Overall, the safety profile of voriconazole in paediatric population was similar to that in adults.
Maltese: Globalment, il-profil tas-sigurtà ta' voriconazole fil-popolazzjoni pedjatrika kien simili għal dak fl-adulti.
English: A single adverse reaction of photophobia of 10 minutes duration was reported.
Maltese: Kienet irrapportata reazzjoni avversa waħda ta' fotofobija li damet 10 minuti.
English: Methadone (CYP3A4 substrate)
Maltese: Methadone (sottostrat CYP3A4)
English: 6 weeks after EOT
Maltese: 6 ġimgħat wara EOT
English: Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
Maltese: ċelluli steminali ematopojetiċi (hematopoietic stem cell transplant, HSCT).
English: Everolimus [CYP3A4 substrate, P-gp substrate]
Maltese: Everolimus [sottostrat ta' CYP3A4, sottostrat ta' P-gp]
English: Rifabutin [potent CYP450 inducer] 300 mg QD
Maltese: Rifabutin [induttur qawwi ta' CYP450] 300 mg QD
English: 5 Includes akathisia and parkinsonism.
Maltese: Tinkludi akatisja u parkinsoniżmu.
English: There have been reports of prolonged visual adverse reactions, including blurred vision, optic neuritis and papilloedema (see section 4.8).
Maltese: Kien hemm rapporti ta' episodji twal ta' reazzjonijiet avversi tal-vista, inklużi vista mċajpra, newrite tal-għajn u papilloedema (ara sezzjoni 4.8).
English: Omeprazole Cmax ↑ 116% Omeprazole AUCτ ↑ 280% Voriconazole Cmax ↑ 15% Voriconazole AUCτ ↑ 41% Other proton pump inhibitors that are CYP2C19 substrates may also be inhibited by voriconazole and may result in increased plasma concentrations of these medicinal products.
Maltese: Omeprazole Cmax ↑ 116% Omeprazole AUCτ ↑ 280% Voriconazole Cmax ↑ 15% Voriconazole AUCτ ↑ 41% Inibituri oħra tal-proton-pump li huma sottostrati ta' CYP2C19 jistgħu wkoll jiġi inibiti minn voriconazole u jistgħu jirriżultaw f'konċentrazzjonijiet ogħla ta' dawn il-prodotti mediċinali fil-plażma.
English: • Sulfonylureas (e.g., tolbutamide, glipizide and glyburide) (used for diabetes)
Maltese: • Sulfonylureas (eż. tolbutamide, glipizide, u glyburide) (użati għad-dijabete)
English: The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to <18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
Maltese: Is-sigurtà ta' voricoanzole ġiet studjata f'288 pazjenti tfal fl-etajiet ta' 2 sa <12-il sena (169) u 12 sa <18-il sena (119) li rċevew voriconazole għal profilassi (183) u għal użu terapewtiku (105) fil-provi kliniċi.
English: Ergot alkaloids (e.g., ergotamine and dihydroergotamine) [CYP3A4 substrates]
Maltese: Alkalojdi tal-ergotina (eż., ergotamine u dihydroergotamine) [sottostrati ta' CYP3A4]
English: Rifabutin (Potent CYP450 inducer)
Maltese: Rifabutin (induttur qawwi ta' CYP450)
English: • Problems with balance or coordination
Maltese: • Problema bil-bilanċ jew koordinazzjoni
English: No subject experienced an interval exceeding the potentially clinically relevant threshold of 500 msec (see section 5.1).
Maltese: Ebda suġġett ma esperjenza intervall li jaqbeż il-limitu kliniku potenzjalment rilevanti ta' 500 msec (ara sezzjoni 5.1).
English: [CYP3A4 substrate; CYP2C19 inhibitor]
Maltese: [sottostrat ta' CYP3A4; inibitur ta' CYP2C19]
English: Pharmacokinetic/pharmacodynamic relationship
Maltese: Relazzjonijiet farmakokinetiċi/farmakodinamiċi
English: Phenytoin [CYP2C9 substrate and potent CYP450 inducer] 300 mg QD
Maltese: Phenytoin [sottostrat ta' CYP2C9 u induttur qawwia ta' CYP450 ] 300 mg QD
English: Aspergillus infections - efficacy in aspergillosis patients with poor prognosis Voriconazole has in vitro fungicidal activity against Aspergillus spp.
Maltese: Infezzjonijiet b'aspergillus - effikaċja f'pazjenti b'aspergillosi bi pronjosi fqira Voriconazole għandu attività fungiċida in vitro kontra l-Aspergillus spp.
English: Phenytoin (CYP2C9 substrate and potent CYP450 inducer) Careful monitoring of phenytoin levels is recommended when phenytoin is co-administered with voriconazole.
Maltese: Phenytoin (sottostrat ta' CYP2C9 u induttur qawwi ta' CYP450) Huwa rakkomandat monitoraġġ attent tal-livelli ta' phenytoin meta phenytoin jiġi amministrat flimkien ma' voriconazole.
English: Voriconazole Hikma must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition (e.g. Aminofusin 10% Plus).
Maltese: Voriconazole Hikma ma għandux jiġi infuż fl-istess pajp jew kannula fl-istess ħin ma' infużjonjiet ta' prodotti mediċinali oħra, inkluż nutriment parenterali (eż Aminofusin 10% Plus).
English: Co-administration of voriconazole and sirolimus is contraindicated (see section 4.3).
Maltese: Amministrazzjoni ta' voriconazole u sirolimus hu kontraindikat (ara sezzjoni 4.3).
English: The safety profile of voriconazole in adults is based on an integrated safety database of more than 2,000 subjects (including 1,603 adult patients in therapeutic trials) and an additional 270 adults in prophylaxis trials).
Maltese: Il-profil tas-sigurtà ta' voriconazole fl-adulti huwa bbażat fuq database integrata tas-sigurtà ta' aktar minn 2,000 suġġett (li jinkludu 1, 603 pazjent adult f'testijiet terapewtiċi) u 270 adult addizzjonali ] fi provi profilattiċi.
English: The asterisk (*) indicates a two-way interaction.
Maltese: L-asterisk (*) jindika interazzjoni miż-żewġ naħat.
English: Omeprazole (40 mg QD)* [CYP2C19 inhibitor; CYP2C19 and CYP3A4 substrate]
Maltese: Omeprazole (40 mg QD)* [inibitur ta' CYP2C19; sottostrat ta' CYP2C19 u CYP3A4]
English: Timepoint
Maltese: TIKKETTAR
English: BATCH NUMBER
Maltese: (numru ta'
English: In an independent published study, Fentanyl AUC∞ ↑ 1.34-fold
Maltese: Fentanyl AUC∞ ↑ 1.34 darbiet
English: Vinca Alkaloids (e.g., vincristine and vinblastine) [CYP3A4 substrates]
Maltese: Alkalojdi Vinca (eż. vincristine u vinblastine) [sottostrati ta' CYP3A4]
English: For example, 15-20 % of Asian populations may be expected to be poor metabolisers.
Maltese: Ngħidu aħna, 15-20 % tal-popolazzjonijiet Asjatiċi aktarx li jkunu metabolizzaturi ħżiena.
English: 9 mg/kg twice daily (a maximum dose of 350 mg twice daily)
Maltese: 8 mg/kg darbtejn kuljum (doża massima ta' 350 mg
English: Voriconazole has not been studied in patients with severe chronic hepatic cirrhosis (Child-Pugh C).
Maltese: Voriconazole ma ġiex studjat f'pazjenti b'ċirrożi tal-fwied kronika severa (Child-Pugh C).
English: Dose reduction of methadone may be needed (see section 4.5).
Maltese: Jista' jkun meħtieġ tnaqqis fiddoża ta' methadone (ara sezzjoni 4.5).
English: Scedosporium spp.
Maltese: Curvularia spp.
English: Endocrine disorders adrenal insufficiency, hypothyroidism hyperthyroidism
Maltese: Disturbi fissistema endokrinarja insuffiċjenza adrenali, ipotirojdiżmu ipertirojdiżmu
English: • Vinca alkaloids (e.g., vincristine and vinblastine) (used in treating cancer)
Maltese: • Alkalojdi vinka (eż., vincristine u vinblastine) (użati fil-kura tal-kanċer)
English: For patients with IA the overall rates of global response at 6 weeks were 64.3% (9/14), the global response rate was 40% (2/5) for patients 2 to <12 years and 77.8% (7/9) for patients 12 to <18 years of age.
Maltese: Għal pazjenti b'IA, ir-rati ġenerali ta' rispons globali wara 6 ġimgħat kienu 64.3% (9/14), ir-rata ta' rispons globali kienet 40% (2/5) għal pazjenti ta' bejn sentejn u <12-il sena u 77.8% (7/9) għal pazjenti ta' bejn 12 sa <18-il sena.
English: • A disorder in which the body's immune system attacks part of the peripheral nervous system
Maltese: • Disturb li fih is-sistema immuni tal-ġisem tattakka parti mis-sistema nervuża periferali
English: Each vial contains 217.6 mg of sodium.
Maltese: Kull kunjett fih 217.6 mg ta' sodju.
English: In vivo studies indicated that CYP2C19 is significantly involved in the metabolism of voriconazole.
Maltese: Studji in vivo indikaw li CYP2C19 huwa involut b'mod sinifikanti fil-metaboliżmu ta' voriconazole.
English: Other treated fungal infections (often with partial or complete response) included isolated cases of Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp.
Maltese: Infezzjonijiet fungali oħra kkurati (ħafna drabi jew b'rispons parzjali jew sħiħ, ara taħt Esperjenza Klinika) kienu jinkludu każi iżolati ta' Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp. fosthom P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis u Trichosporon spp. fosthom infezzjonijiet T. beigelii.
English: Pharmacotherapeutic group: Antimycotics for systemic use, - triazole derivatives ATC code: J02AC03
Maltese: Antimikotċi għal użu sistemiku, derivattivi tat-triazole, Kodiċi ATC:
English: Efavirenz (CYP450 inducer; CYP3A4 inhibitor and substrate)
Maltese: Efavirenz (induttur ta' CYP450; inibitur u sottostrat ta' CYP3A4)
English: [CYP3A4 substrates, inhibitors or CYP450 inducers]
Maltese: [sottostrati ta' CYP3A4, inihibituri jew indutturi ta' CYP450]
English: Fluconazole (200 mg QD) [CYP2C9, CYP2C19 and CYP3A4 inhibitor]
Maltese: Fluconazole (200 mg QD) [inibitur ta' CYP2C9, CYP2C19 u CYP3A4]
English: There was evidence of attenuation with repeated doses of voriconazole.
Maltese: Kien hemm evidenza ta' attenwazzjoni b'dożi ripetuti ta' voriconazole.
English: • Benzodiazepines (e.g., midazolam, triazolam) (used for severe insomnia and stress)
Maltese: • Benzodiazepines (eż. midazolam, triazolam) (użati għal nuqqas ta' rqad sever u stress)
English: Tacrolimus (0.1 mg/kg single dose)
Maltese: Tacrolimus (doża waħda ta' 0.1 mg/kg)
English: In the 22 patients less than 2 years old who received voriconazole in a compassionate use programme, the following adverse reactions (for which a relationship to voriconazole could not be excluded) were reported: photosensitivity reaction (1), arrhythmia (1), pancreatitis (1), blood bilirubin increased (1), hepatic enzymes increased (1), rash (1) and papilloedema (1).
Maltese: Fit-22 pazjent ta' anqas minn sentejn li rċevew voriconazole fi programm ta' użu ħanin, kienu rrapportati r-reazzjonijiet avversi li ġejjin (li għalihom ma setgħetx tiġi eskluża relazzjoni ma' voriconazole): reazzjoni ta' fotosensittività (1), arritmija (1), pankreatite (1), bilirubin fid-demm aktar (1), enzimi epatiċi aktar (1), raxx (1) u papilloedima (1).
English: Prophylaxis with study drug was started immediately after HSCT: 224 received voriconazole and 241 received itraconazole.
Maltese: Profilassi bil-mediċina tal-istudju nbdiet immedjatament wara HSCT: 224 irċevew voriconazole u 241 irċevew itraconazole.
English: Prednisolone (60 mg single dose) [CYP3A4 substrate]
Maltese: Prednisolone (doża waħda ta' 60 mg) [sottostrat ta' CYP3A4]
English: • Phenytoin (used to treat epilepsy).
Maltese: • Phenytoin (użat għall-kura ta' l-epilessija).
English: retinal haemorrhage optic nerve disorder7, papilloedema8, oculogyric crisis, diplopia, scleritis, blepharitis optic atrophy, corneal opacity
Maltese: emorraġija tarretina mard tan-nerv ottiku7, papilloedima8, kriżi okuloġirika, tara doppju, sklerite, blefarite atrofija ottika, opaċità talkornea
English: • Rifampicin (used for treating tuberculosis)
Maltese: • Rifampicin (użat għall-kura tat-tuberkulosi)
English: 5% Glucose and 0.45% Sodium Chloride Intravenous Infusion 5% Glucose Intravenous Infusion 5% Glucose in 20 mEq Potassium Chloride Intravenous Infusion 0.45% Sodium Chloride Intravenous Infusion 5% Glucose and 0.9% Sodium Chloride Intravenous Infusion
Maltese: 5% Glucose u Lactated Ringer's Infużjoni ġol-vina 5% Glucose u 0.45% Sodium Chloride Infużjoni ġol-vina 5% Infużjoni ġol-vina ta' Glucose 5% Glucose fi 20 mEq ta' Infużjoni ġol-vina ta' Potassium Chloride 0.45% Infużjoni ġol-vina ta' Sodium Chloride