FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity reactions including angioedema have been reported in patients receiving prasugrel, including in patients with a history of hypersensitivity reaction to clopidogrel.
Maltese: Reazzjonijiet ta' sensittività eċċessiva inkluża l­anġjoedima ġew irrapportati f'pazjenti li qed jirċievu prasugrel, inkluż f'pazjenti b'passat ta' reazzjoni ta' sensittività eċċessiva għal clopidogrel.
English: Therapeutic experience with prasugrel is limited in patients with renal impairment (including ESRD) and in patients with moderate hepatic impairment.
Maltese: L­esperjenza terapewtika b'prasugrel f'pazjenti b'indeboliment tal-kliewi (inkluż ESRD) u f'pazjenti b'indeboliment moderat tal-fwied hija limitata.
English: Symptomatic ICHe
Maltese: Fatali ICH sintomatika d
English: Prasugrel Mylan can also be concomitantly administered with ASA, heparin, digoxin, and medicinal products that elevate gastric pH, including proton pump inhibitors and H2 blockers.
Maltese: Prasugrel Mylan jista' jingħata wkoll flimkien ma' ASA, eparina, digoxin, u prodotti mediċinali li jgħollu l­pH tal­istonku, inklużi inibituri tal-pompa tal-proton u mblokkaturi ta' H2.
English: Prasugrel Mylan 5 mg: Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel.
Maltese: Prasugrel Mylan 5 mg: Kull pillola fiha prasugrel besilate ekwivalenti għal 5 mg prasugrel.
English: Pharmacokinetics of prasugrel and its inhibition of platelet aggregation were similar in subjects with mild to moderate hepatic impairment compared to healthy subjects.
Maltese: Il-farmakokinetika u l­inibizzjoni ta' l­aggregazzjoni ta' plejtlets ta' prasugrel kienu simili f'suġġetti b'indeboliment tal-fwied ħafif jew moderat meta mqabbel ma' suġġetti b'saħħithom.
English: Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel.
Maltese: Kull pillola fiha prasugrel besilate ekwivalenti għal 5 mg prasugrel.
English: NAME OF THE MEDICINAL PRODUCT Prasugrel Mylan 5 mg film-coated tablets Prasugrel Mylan 10 mg film-coated tablets
Maltese: Informazzjoni għall-utent Prasugrel Mylan 5 mg pilloli miksija b'rita Prasugrel Mylan 10 mg pilloli miksija b'rita prasugrel
English: Because of the potential for increased risk of bleeding, chronic NSAIDs (including COX-2 inhibitors) and Prasugrel Mylan should be co-administered with caution (see section 4.4).
Maltese: Minħabba l­potenzjal ta' riskju akbar ta' fsada, NSAIDs kroniċi (inklużi inibituri ta' COX­2) u Prasugrel Mylan għandhom jingħataw flimkien b'kawtela (ara sezzjoni 4.4).
English: The use of Prasugrel Mylan in patients ≥75 years of age is generally not recommended.
Maltese: Normalment l­użu ta' Prasugrel Mylan f'pazjenti ≥75 sena mhux rakkomandat.
English: b Other standard therapies were used as appropriate.
Maltese: e a Intużaw terapiji standard oħra skont il-bżonn.
English: Talk to your doctor before taking Prasugrel Mylan.
Maltese: Mediċini oħra u Prasugrel Mylan
English: Prasugrel should be used with caution in patients ≥75 years of age due to the potential risk of bleeding in this population (see sections 4.2 and 4.4).
Maltese: Prasugrel għandu jintuża b'kawtela f'pazjenti ta' ≥75 sena minħabba r­riskju potenzjali ta' fsada f'din il-popolazzjoni (ara sezzjonijiet 4.2 u 4.4).
English: In the All ACS population, prasugrel was associated with a lower incidence of CV death, non-fatal MI, or non-fatal stroke compared to clopidogrel, regardless of baseline characteristics such as age, sex, body weight, geographical region, use of GP IIb/IIIa inhibitors, and stent type.
Maltese: Fil-popolazzjoni tal-Pazjenti Kollha b'ACS, prasugrel kien assoċjat ma' inċidenza aktar baxxa ta' mewt kardjovaskulari, MI mhux fatali, jew puplesija mhux fatali meta mqabbel ma' clopidogrel, mingħajr kunsiderazzjoni tal-karateristiċi bażi bħall-età, is-sess, il-piż tal-ġisem, ir-reġjun ġeografiku, l­użu ta' inibituri ta' GP IIb/IIIa, it-tip ta' stent.
English: c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Maltese: c Kwalunkwe emorraġija intrakranjali jew kwalunkwe tip ta' fsada evidenti b'mod kliniku assoċjata ma' tnaqqis fl-emoglobina ta' ≥5 g/dL.
English: • ≥75 years of age (see below).
Maltese: • ≥75 sena (ara hawn taħt).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction.
Maltese: Informazzjoni mhux klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva, ma turi l­ebda periklu speċjali għall-bnedmin.
English: Higher inhibition of platelet aggregation was observed in patients switched to prasugrel 10 mg compared with those treated with clopidogrel 150 mg.
Maltese: Ġiet osservata inibizzjoni ogħla ta' aggregazzjoni ta' plejtlets fil-pazjenti li nqalbu għal 10 mg prasugrel meta mqabbel ma' dawk ikkurati b'150 mg clopidogrel.
English: • Sudden confusion, difficulty speaking or understanding others
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura
English: Subcutaneous haematoma
Maltese: Disturbi vaskulari Ematoma
English: • with concomitant administration of medicinal products that may increase the risk of bleeding, including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics.
Maltese: • li fl-istess waqt jingħataw prodotti mediċinali li jistgħu jkabbru r­riskju ta' fsada, inklużi sustanzi kontra l-koagulazzjoni tad-demm li jittieħdu mill-ħalq, clopidogrel, mediċini anti infjammatorji mhux sterojdi (NSAIDs), u fibrinolitiċi.
English: Approximately 40% of patients (in each of the treatment groups) received GP IIb/IIIa inhibitors in support of PCI (no information available regarding the type of GP IIb/IIIa inhibitor used).
Maltese: Madwar 40% tal-pazjenti (f'kull grupp ta' kura) irċevew inibitur ta' GP IIb/IIIa bħala sostenn għal PCI (m'hemmx tagħrif dwar it-tip ta' inibitur GP IIb/IIIa li ntuża).
English: Exposure in subjects of African and Hispanic descent is comparable to that of Caucasians.
Maltese: L­espożizzjoni f'suġġetti ta' dixxendenza Afrikana u Spanjola jew Latin-Amerikana hija komparabbli ma' dik tal-Kawkażi.
English: HDPE bottle: Do not store above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l­attivitajiet u l­interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talAwtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Requiring inotropes Requiring surgical intervention Requiring transfusion (≥4 units) TIMI minor bleedingf a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study
Maltese: Ħtieġa ta' inotropes Ħtieġa ta' intervent kirurġiku Ħtieġa ta' trasfużjoni (≥4 unitajiet) Fsada Minuri skont TIMI
English: * ICH = intracranial haemorrhage.
Maltese: * ICH = emorraġija fir-ras.
English: In TRITON, for every 1000 patients treated with prasugrel, there were 22 fewer patients with myocardial infarction, and 5 more with non-CABG-related TIMI major haemorrhages, compared with patients treated with clopidogrel.
Maltese: F'TRITON, għal kull 1000 pazjent ikkurat b'prasugrel, kien hemm 22 pazjent anqas b'infart mijokardijaku, u 5 aktar b'emorraġiji maġġuri skont TIMI relatata ma' non-CABG, meta mqabbel ma' pazjenti kkurati b'clopidogrel.
English: The safety and efficacy of Prasugrel Mylan in children below age 18 has not been established.
Maltese: Is-sigurtà u l­effikaċja ta' Prasugrel Mylan fit-tfal ta' taħt it-18-il sena ma ġewx determinati s'issa.
English: TIMI major bleedingc
Maltese: • Demm mal-ippurgar
English: Blister packs only: Do not store above 30°C.
Maltese: Pakketti bil-folji biss: Taħżinx f'temperatura 'l fuq minn 30°C.
English: Prasugrel had no effect on fertility of male and female rats at oral doses up to an exposure 240 times the recommended daily human maintenance dose (based on mg/m²).
Maltese: Prasugrel ma kellu l-ebda effett fuq il-fertilità ta' firien maskili u femminili b'dożi mill-ħalq sa espożizzjoni ta' 240 darba aktar mid-doża ta' manteniment irrakkomandata għall-umani li tittieħed kuljum (ibbażata fuq mg/m²).
English: If you weigh less than 60 kg or are more than 75 years of age, the dose is 5 mg Prasugrel Mylan per day.
Maltese: Jekk tiżen inqas minn 60 kg jew għandek iżjed minn 75 sena, id-doża hi ta' 5 mg ta' Prasugrel Mylan kuljum.
English: Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 5.2).
Maltese: L­għoti fuq stonku vojt tad-doża ta' kkargar ta' 60 mg prasugrel jista' jipprovdi l-aktar mod mgħaġġel biex jibda jaħdem (ara sezzjoni 5.2).
English: In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients ≥75 years old taking 5 mg prasugrel was approximately half that in patients <65 years old taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was reduced but was noninferior compared to 10 mg.
Maltese: Fi studju f'pazjenti b'aterosklerożi stabbli, il-medja tal-AUC tal-metabolit attiv f'pazjenti ≥75 sena li kienu qed jieħdu 5 mg prasugrel kienet ta' madwar nofs dik tal-pazjenti <65 sena li kienu qed jieħdu 10 mg prasugrel u l-effett kontra l-plejtlets tal-5 mg kien anqas iżda ma kienx inferjuri meta mqabbel mal-10 mg.
English: e ICH = intracranial haemorrhage.
Maltese: e ICH = emorraġija fir-ras.
English: ◦ Patients weighing <60 kg should have a reduced maintenance dose of 5 mg
Maltese: Għandha tintuża doża ta' manteniment ta' 5 mg.
English: There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4).
Maltese: L­esperjenza terapewtika f'pazjenti b'disfunzjoni tal-fwied ħafifa u moderata hija limitata (ara sezzjoni 4.4).
English: Of these, bleeding was the most common adverse reaction for both drugs leading to study drug discontinuation (2.5% for prasugrel and 1.4% for clopidogrel).
Maltese: Minn dawn, il-fsada kienet ir-reazzjoni avversa l­aktar komuni għaż-żewġ mediċini li wasslet għat-twaqqif tal-mediċina taħt studju (2.5% għal prasugrel u 1.4% għal clopidogrel).
English: Study TADO teste the use of prasugrel (n=171) vs placebo (n=170) in patients, ages 2 to less than 18 years of age, with sickle cell anaemia for reduction of vaso occlusive crisis in a phase III study.
Maltese: L­istudju TADO ttestja l­użu ta' prasugrel (n=171) kontra plaċebo (n=170) f'pazjenti, b'etajiet minn sentejn sa inqas minn 18-il sena, b'anemija tat-tip sickle cell għal tnaqqis fi kriżi vaso okklussiva fi studju ta' fażi
English: Concomitant administration of Prasugrel Mylan with coumarin derivatives other than warfarin has not been studied.
Maltese: It-teħid ta' Prasugrel Mylan flimkien ma' derivattivi ta' coumarin minbarra warfarin ma ġiex studjat.
English: TIMI Major bleedingb Life-threateningc Fatal
Maltese: • Għadd baxx tal-plejtlets fid-demm
English: You should tell your doctor immediately if you develop a medical condition called Thrombotic Thrombocytopaenic Purpura (or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Maltese: Għandek minnufih tgħid lit-tabib tiegħek jekk tiżviluppa kundizzjoni medika msejħa Purpura Tromboċitopenika Trombotika (jew TTP) li tinkludi deni u tbenġil taħt il-ġilda li jista' jidher bħala ponot ħomor żgħar ħafna, flimkien jew mingħajr għeja kbira li m'għandhiex spjegazzjoni, konfużjoni, sfurija tal-ġilda jew tal-għajnejn (suffejra) (ara sezzjoni 4 ‘Effetti sekondarji possibbli').
English: Use of any thienopyridine within 5 days before enrolment was an exclusion criterion.
Maltese: L­użu ta' xi thienopyridine fi żmien 5 ijiem qabel ir-reġistrazzjoni kien kriterju ta' esklużjoni.
English: b Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Maltese: b Kwalunkwe emorraġija intrakranjali jew kwalunkwe tip ta' fsada evidenti b'mod kliniku assoċjata ma' tnaqqis fl-emoglobina ta' ≥5 g/dL.
English: NAME OF THE MEDICINAL PRODUCT Prasugrel Mylan 10 mg film-coated tablets Prasugrel
Maltese: Prasugrel Mylan 10 mg pilloli miksija b'rita Prasugrel
English: This medicine is available in plastic bottles containing a desiccant and 28 or 30 film-coated tablets and in blister packs containing 28, 30, 84 or 98 film-coated tablets.
Maltese: Din il-mediċina hija disponibbli fi fliexken tal-plastik li jkun fihom dessikant u 28 jew 30 pillola miksija b'rita u f'pakketti bil-folji li jkun fihom 28, 30, 84 jew 98 pillola miksija b'rita.
English: Clopidogrelb + ASA (N=4980)
Maltese: ASA (N=4980)
English: Clopidogrelb + ASA (N=6716)
Maltese: ASA (N=6716)
English: Prasugrel Mylan 5 mg film-coated tablets prasugrel
Maltese: Prasugrel Mylan 5 mg pilloli miksija b'rita prasugrel
English: It was to be available as capsules (120 mg).
Maltese: Kienet sejra tkun disponibbli bħala kapsuli (120 mg).
English: 27 June 2014 EMA/354906/2014 EMEA/H/C/003720
Maltese: EMEA/H/C/003720
English: Faldaprevir Boehringer Ingelheim is an antiviral medicine that contains the active substance faldaprevir.
Maltese: Faldaprevir Boehringer Ingelheim huwa mediċina antivirali li fiha s-sustanza attiva faldaprevir.
English: What is Faldaprevir Boehringer Ingelheim?
Maltese: X'inhu Faldaprevir Boehringer Ingelheim?
English: The active substance in Faldaprevir Boehringer Ingelheim, faldaprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply.
Maltese: Is-sustanza attiva fi Faldaprevir Boehringer Ingelheim, il-faldaprevir, timblokka l-azzjoni ta' enzima msejħa ‘NS3/4A serine protease' fil-virus tal-epatite Ċ, li hija essenzjali għall-virus biex jimmultiplika.
English: The company presented data including the results of three main studies involving 1,705 patients with chronic hepatitis C, in which faldaprevir was compared with placebo (a dummy treatment) when added to two other medicines for hepatitis C, peginterferon and ribavirin.
Maltese: Il-kumpanija ppreżentat dejta li tinkludi r-riżultati ta' tliet studji ewlenin li involvew 1,705 pazjent b'epatite Ċ kronika, li fihom, il-faldaprevir tqabbel ma' plaċebo (kura finta) meta miżjud ma' żewġ mediċini oħra għall-epatite Ċ, peginterferon u ribavirin.
English: A fourth study involving 308 patients examined the effects of treatment with Faldeprevir Boehringer Ingelheim in patients who also had HIV infection.
Maltese: Ir-raba' studju, li involva 308 pazjenti, eżamina l-effetti tal-kura b'Faldeprevir Boehringer Ingelheim f'pazjenti li kellhom ukoll infezzjoni tal-HIV.
English: Faldaprevir Boehringer Ingelheim was expected to be used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Maltese: Faldaprevir Boehringer Ingelheim kien mistenni li jintuża biex jikkura adulti b'epatite Ċ (marda infettiva li taffetwa l-fwied, ikkawżata mill-virus tal-epatite Ċ) kronika (fit-tul).
English: On 10 June 2014, Boehringer Ingelheim International GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Faldaprevir Boehringer Ingelheim, for the treatment of hepatitis C.
Maltese: Fl-10 ta' Ġunju 2014, Boehringer Ingelheim International GmbH għarrfet uffiċjalment lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni tagħha li tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Faldaprevir Boehringer Ingelheim, għall-kura tal-epatite Ċ.
English: It was to be used in combination with other medicines.
Maltese: Kien sejjer jintuża f'kombinazzjoni ma' mediċni oħra.
English: Remaining clinical trials were expected to finish on schedule by July 2014.
Maltese: Provi kliniċi li fadal kienu mistennija li jispiċċaw skont kif skedat sa Lulju 2014.
English: How is Faldaprevir Boehringer Ingelheim expected to work?
Maltese: Kif huwa mistenni li jaħdem Faldaprevir Boehringer Ingelheim?
English: Several varieties (genotypes) of hepatitis C virus exist: Faldaprevir Boehringer Ingelheim was intended to be used against genotype 1.
Maltese: Jeżistu diversi varjetajiet (ġenotipi) ta' virus tal-epatite Ċ:
English: What was Faldaprevir Boehringer Ingelheim expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Faldaprevir Boehringer Ingelheim?
English: Statins (e.g., lovastatin)
Maltese: Statins (e.ż., lovastatin)
English: Astemizole, cisapride, pimozide, quinidine and terfenadine
Maltese: Astemizole, cisapride, pimozide, quinidine u terfenadine
English: Non-Steroidal AntiInflammatory Drugs (NSAIDs)
Maltese: Mediċini anti-infjammatorji non-sterojdali (NSAIDs)
English: Lactose monohydrate Pregelatinized starch Croscarmellose sodium Povidone
Maltese: Lactose monohydrate Pregelatinised starch Croscarmellose sodium Povidone
English: [UDP-glucuronyl transferase substrate]
Maltese: UDP-glucuronyl transferas]
English: • Serious dermatological adverse reactions (including SCC)
Maltese: Reazzjonijiet avversi dermatoloġiċi serji (inkluż SCC)
English: Ritonavir (protease inhibitor)
Maltese: Ritonavir (inibitur talprotease )
English: *ADR identified post-marketing
Maltese: *ADR identifikata wara t-tqegħid fis-suq
English: Efavirenz (a non-nucleoside reverse transcriptase inhibitor)
Maltese: Efavirenz (inibittur tan-nonnucleoside reverse transcriptase) [induttur ta'
English: In vitro activity against clinical isolates has been observed for Acremonium spp., Alternaria spp.,
Maltese: Attività in vitro kontra iżolati kliniċi kienet osservata għal Acremonium spp., Alternaria spp.,
English: Digoxin Cmax ↔ Digoxin AUCτ ↔
Maltese: Digoxin Cmax ↔ Digoxin AUC ↔
English: Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park, Paola, PLA 3000
Maltese: KW20A Kordin Industrial Park, Paola, PLA 3000
English: Benzodiazepines (e.g., midazolam, triazolam, alprazolam)
Maltese: Benzodiazepines (e.ż., midazolam, triazolam, alprazolam)
English: R-methadone (active) Cmax  R-methadone (active) AUCτ  S-methadone Cmax  65% S-methadone AUCτ  103%
Maltese: R-methadone (attiv) Cmax 31% R-methadone (attiv) AUC 47% S-methadone Cmax 65% S-methadone AUC 103%
English: Ciclosporin Cmax  13% Ciclosporin AUCτ  70%
Maltese: Ciclosporin Cmax 13% Ciclosporin AUC 70%
English: [Mechanism of interaction]
Maltese: [Mekkaniżmu ta' interazzjoni]
English: MIC breakpoint (mg/L)
Maltese: MIC breakpoint (mg/L) ≤S (Suxxettibbli)
English: including A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, Candida spp., including C. albicans, C. glabrata, C. krusei, C. parapsilosis and C. tropicalis and limited numbers of C. dubliniensis, C. inconspicua, and C. guilliermondii, Scedosporium spp., including S. apiospermum, S. prolificans and Fusarium spp.
Maltese: A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, Candida spp., fosthom C. albicans, C. glabrata, C. krusei, C. parapsilosis u C. tropicalis u ammonti limitati ta' C. dubliniensis, C. inconspicua, u C. guilliermondii, Scedosporium spp., fosthom S. apiospermum, S. prolificans u Fusarium spp.
English: and Sporothrix spp.
Maltese: Curvularia spp.u Sporothrix spp.
English: Sulfonylureas (e.g., tolbutamide, glipizide, glyburide)
Maltese: Sulfonylureas (e.ż., tolbutamide, glipizide, glyburide)
English: Bipolaris spp., Cladophialophora spp., and Histoplasma capsulatum, with most strains being inhibited by concentrations of voriconazole in the range 0.05 to 2 μg/ml.
Maltese: Bipolaris spp., Cladophialophora spp., u Histoplasma capsulatum, bil-maġġoranza tal-forom jiġu mwaqqfa b'konċentrazzjonijiet ta' voriconazole fil-medda ta' 0.05 sa 2 g/ml.
English: cutaneous lupus erythemato sus*, ephelides*, lentigo*
Maltese: lupus eritematoż us talġilda*, efelide*, lentigo*
English: Vinca Alkaloids (e.g., vincristine and vinblastine)
Maltese: Alkalojdi Vinca (e.ż., vincristine u vinblastine)
English: and Fusarium spp.
Maltese: u Fusarium spp.
English: Macrolide antibiotics Erythromycin (1 g BID)
Maltese: Erythromycin (1 g BID)
English: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Maltese: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow,
English: • Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac) (used for treating pain and
Maltese: • Mediċini anti-infjammatorji non-sterojdali (e.ż. ibuprofen, diclofenac) (użati kontra l-uġigħ u infjammazzjoni)
English: Voriconazole Accord is an antifungal medicine.
Maltese: Voriconazole Accord huwa mediċina antifungali.
English: 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: Everolimus (CYP3A4 substrate, P-gp substrate)
Maltese: Everolimus (substrat CYP3A4, substrat P-gp)
English: Indinavir Cmax ↔ Indinavir AUCτ ↔ Voriconazole Cmax ↔ Voriconazole AUCτ ↔
Maltese: Ikkuntattja lit-tabib tiegħek immedjatament jekk tinqabad tqila waqt li tkun qiegħda tieħu Voriconazole Accord.
English: Ergot alkaloids (e.g., ergotamine and dihydroergotamine)
Maltese: Alkalojdi tal-ergotina (e.ż., ergotamine u dihydroergotamine)
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: Carbamazepine and longacting barbiturates (e.g., phenobarbital, mephobarbital)
Maltese: Carbamazepine u barbiturates li jaħdmu fit-tul (e.ż., phenobarbital, mephobarbital)
English: [increases gastric pH]
Maltese: [jżid il-pH gastriku]
English: 6 See “Visual impairments” paragraph in section 4.8.
Maltese: 6 Ara l-paragrafu “Indebolimenti fil-vista” fis-sezzjoni 4.8.
English: In an independent published study, Alfentanil AUC0-∞  6fold.
Maltese: Fi studju indipendenti ppubblikat, Alfentanil AUC0- 6 darbiet
English: Itraconazo le (N=109)
Maltese: Itraconazole (N=109)
English: EU/1/13/835/010 2 film-coated tablets EU/1/13/835/011 10 film-coated tablets EU/1/13/835/012 14 film-coated tablets EU/1/13/835/013 20 film-coated tablets EU/1/13/835/014 28 film-coated tablets EU/1/13/835/015 30 film-coated tablets EU/1/13/835/016 50 film-coated tablets EU/1/13/835/017 56 film-coated tablets EU/1/13/835/018 100 film-coated tablets EU/1/13/835/025 10x1 film-coated tablets EU/1/13/835/026 14x1 film-coated tablets EU/1/13/835/027 28x1 film-coated tablets EU/1/13/835/028 30x1 film-coated tablets EU/1/13/835/029 56x1 film-coated tablets EU/1/13/835/030 100x1 film-coated tablets
Maltese: EU/1/13/835/010 2 pilloli miksija b'rita EU/1/13/835/011 10 pilloli miksija b'rita EU/1/13/835/012 14 pilloli miksija b'rita EU/1/13/835/013 20 pilloli miksija b'rita EU/1/13/835/014 28 pilloli miksija b'rita EU/1/13/835/015 30 pilloli miksija b'rita EU/1/13/835/016 50 pilloli miksija b'rita EU/1/13/835/017 56 pilloli miksija b'rita EU/1/13/835/018 100 pilloli miksija b'rita EU/1/13/835/025 10x1 pillola miksija b'rita EU/1/13/835/026 14x1 pillola miksija b'rita EU/1/13/835/027 28x1 pillola miksija b'rita EU/1/13/835/028 30x1 pillola miksija b'rita EU/1/13/835/029 56x1 pillola miksija b'rita EU/1/13/835/030 100x1 pillola miksija b'rita
English: 9 mg/kg twice a day (a maximum dose of 350 mg twice daily)
Maltese: 9 mg/kg darbtejn kuljum (doża massima ta' 350 mg darbtejn kuljum)
English: The ERG measures electrical currents in the retina.
Maltese: L-ERG ikejjel ilkurrenti elettriċi fir-retina.