FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, the in vitro characterisation of phenotypic cross-resistance between lopinavir and other protease inhibitors suggest that decreased susceptibility to lopinavir correlated closely with decreased susceptibility to ritonavir and indinavir, but did not correlate closely with decreased susceptibility to amprenavir, saquinavir, and nelfinavir.
Maltese: Fuq kollox, il-karatterizzazzjoni in vitro ta' cross-resistance fenotipika bejn lopinavir u impedituri protejaż oħrajn tissuġġerixxi li ssuxxettibilità imnaqqsa għal lopinavir ikkorrelatat mill-qrib mas-suxxettibilità imnaqqsa għal ritonavir u indinavir, iżda ma kkorrelatatx mill-qrib mas-suxxettibilità imnaqqsa għal amprenavir, saquinavir, u nelfinavir.
English: Concomitant use of sildenafil prescribed for the treatment of pulmonary arterial hypertension with lopinavir/ritonavir is contraindicated (see section 4.3).
Maltese: L-għoti ta' sildenafil meta preskritt għalltrattament ta' pressjoni għolja fl-arterji pulmonari flimkien ma' lopinavir/ritonavir huwa kontro-indikat (ara sezzjoni 4.3).
English: More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.5 and refer to the bedaquiline SmPC).
Maltese: Monitoraġġ aktar frekwenti b'elettrokardjogramma u l-monitoraġġ ta' transaminases huwa rrakkomandat (ara sezzjoni 4.5 u rreferi għall-SmPC ta' bedaquiline).
English: Serum concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir, resulting in increased risk of tumor lysis syndrome at the dose initiation and during the ramp-up phase (see section 4.3 and refer to the venetoclax SmPC).
Maltese: Il-konċentrazzjonijiet fis-serum jistgħu jiżdiedu minħabba linibizzjoni ta' CYP3A minn lopinavir/ritonavir, li jirriżultaw f'żieda fir-riskju tas-sindrome tallisi tat-tumur fil-bidu tad-doża u matul il-fażi ta' żieda fid-doża (ara sezzjoni 4.3 u rreferi għallSmPC ta' venetoclax).
English: M06-802 was a randomised open-label study comparing the safety, tolerability and antiviral activity of oncedaily and twice daily dosing of lopinavir/ritonavir tablets in 599 subjects with detectable viral loads while receiving their current antiviral therapy.
Maltese: M06-802 kien studju open-label u li fih il-parteċipanti ntgħażlu b'mod każwali, li qabbel is-sigurtà, ittollerabilità u l-attività antivirali ta'dożaġġ darba kuljum u dożaġġ darbtejn kuljum tal-pilloli lopinavir/ritonavir f'599 individwu li kellhom ammonti virali li setgħu jiġu osservati waqt li kieu qed jirċievu t-terapija antivirali kurrenti tagħhom.
English: − colchicine (used to treat gout) if you have kidney and/or liver problems (see the section on Other medicines and Lopinavir/Ritonavir); elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV]); ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used to treat chronic hepatitis C virus [HCV]);
Maltese: Fusidic acid użat biex jittratta infezzjonijiet fit-tul flgħadam u fil-ġogi jista' jittieħed taħt osservazzjoni ta' tabib (ara sezzjoni Mediċini oħra u Lopinavir/Ritonavir Mylan); - colchicine (jintuża għal trattament tal-gotta) jekk għandek problemi tal-kliewi u/jew tal-fwied (ara t-taqsima dwar Mediċini oħra u Lopinavir/Ritonavir Mylan); - elbasvir/grazoprevir (jintużaw għall-kura tal-virus ta' epatite Ċ kronika [HCV]); - ombitasvir/paritaprevir/ritonavir bi jew mingħajr dasabuvir (jintużaw għall-kura tal-virus talepatite Ċ kronika [HCV]); - avanafil jew vardenafil (użat biex jittratta disfunzjoni erettili); - sildenafil użat għall-kura ta' ipertensjoni arterjali pulmonari (pressjoni għolja fl-arterja talpulmun).
English: If a patient is already taking St John's wort, stop St John's wort and if possible check viral levels.
Maltese: Jekk pazjent ikun diġà qiegħed jieħu l-fexfiex tar-raba' (St John's wort), waqqafulu u jekk ikun possibbli iċċekkja llivelli virali.
English: In case of co-administration of Lopinavir/Ritonavir Mylan with contraceptives containing ethinyl oestradiol (whatever the contraceptive formulation e.g. oral or patch), additional methods of contraception must be used.
Maltese: Rakkomandazzjoni klinika dwar l-għoti ta' prodotti mediċinali oħra flimkien ma' Lopinavir/Ritonavir Mylan oestradiol (tkun xi tkun ilformolazzjoni tal-kontraċettiv eż orali jew garża li tipprovdi mediċina li tgħaddi minn ġolġilda), għandhom jintużaw metodi ta' kontraċezzjoni addizzjonali.
English: The use of vardenafil with Lopinavir/Ritonavir Mylan is contraindicated (see section 4.3).
Maltese: L-użu ta' vardenafil flimkien ma' Lopinavir/Ritonavir Mylan huwa kontro-indikat (ara sezzjoni 4.3).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg ritonavir as a pharmacokinetic enhancer.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola miksija b'rita fiha 100 mg ta 'lopinavir koformulat b'25 mg ta 'ritonavir bħala enhancer farmakokinetiku.
English: Lovastatin and Simvastatin Lovastatin, Simvastatin: Markedly increased plasma concentrations due to CYP3A inhibition by lopinavir/ritonavir.
Maltese: Iżjed u iżjed , każi rari ta' żidiet flintervall PR ġew rrapurtati waqt t-terapija b'lopinavir/ritonavir.
English: - Multipacks containing 60 or 60x1 (2 cartons of 30 or 30x1) film-coated tablets.
Maltese: - Pakketti multipli li jkun fihom 60 jew 60x1 (2 kartuni ta' 30 jew 30x1) pillola miksija b'rita.
English: Concomitant administration of Lopinavir/Ritonavir Mylan and quetiapine is contraindicated as it may increase quetiapine-related toxicity.
Maltese: Amministrazzjoni konkomitanti ta' Lopinavir/Ritonavir Mylan ma' quetiapine huwa kontraindikat għax jista' jżid ittossiċità relatata ma' quetiapine.
English: - Lopinavir/Ritonavir Mylan is not a cure for HIV infection or AIDS - Lopinavir/ritonavir is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
Maltese: - Lopinavir/ritonavir jintuża minn tfal ta' sentejn jew ikbar, minn adoloxxenti u minn adulti li huma infettati bl-HIV, il-virus li jikkawża l-AIDS.
English: The use of rivaroxaban is not recommended in patients receiving concomitant treatment with Lopinavir/Ritonavir Mylan (see section 4.4).
Maltese: Rakkomandazzjoni klinika dwar l-għoti ta' prodotti mediċinali oħra flimkien ma' Lopinavir/Ritonavir Mylan b'Lopinavir/Ritonavir Mylan (ara sezzjoni 4.4).
English: At least 13 lopinavir oxidative metabolites have been identified in man.
Maltese: Mill-inqas 13 -il metabolit ossidattiv ta' lopinavir ġew identifikati fil-bniedem.
English: The adult dose of lopinavir/ritonavir tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2. For children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, please refer to the dosing guideline tables below.
Maltese: Id-doża għall-adulti tal-pilloli lopinavir/ritonavir (400/100 mg darbtejn kuljum) tista 'tintuża fi tfal li jiżnu 40 kg jew aktar, jew li għandhom Erja tas-Superfiċje tal-Ġisem (Body Surface Area, (BSA)*) ta ' aktar minn 1.4 m2.
English: Outcomes at Week 48: Study M98-863 Lopinavir/ritonavir (N=326)
Maltese: Tabella 1 Riżultati ta' ġimgħa 48: Studju M98-863
English: Concomitant use of avanafil or vardenafil and lopinavir/ritonavir is contraindicated (see section 4.3).
Maltese: L-użu ta' avanafil jew vardenafil flimkien ma' lopinavir/ritonavir huwa kontra-indikat (ara sezzjoni 4.3).
English: Cases of pancreatitis have been reported in patients receiving lopinavir/ritonavir, including those who developed hypertriglyceridaemia.
Maltese: Pankreatite Ġew irrapurtati każijiet ta' pankreatite f'pazjenti li qegħdin jieħdu lopinavir/ritonavir, inklużi dawk li żviluppaw l-ipertrigliċeridemija.
English: Due to the risk of QTc prolongation associated with DM-6705, if coadministration of delamanid with Lopinavir/Ritonavir Mylan is considered necessary, very frequent ECG monitoring throughout the full delamanid treatment period is recommended (see section 4.4 and refer to the delamanid SmPC).
Maltese: Għalhekk, jekk l-għoti ta' delamanid flimkien ma' lopinavir/ritonavir huwa kkunsidrat neċessarju, huwa rrakkomandat monitoraġġ ta' ECG frekwenti ħafna matul il-perjodu kollu tat-trattament ta' delamanid (ara sezzjoni 4.5 u rreferi għall-SmPC ta' delamanid).
English: Interactions between lopinavir/ritonavir and co-administered medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, once daily as “QD”, twice daily as “BID” and three times daily as "TID").
Maltese: L-interazzjonijiet bejn lopinavir/ritonavir u prodotti mediċinali li jittieħdu ma' lopinavir/ritonavir huma mniżżla fit-tabella t'hawn taħt (iż-żidiet huma indikati bħala “↑”, tnaqqis bħala “↓”, l-ebda tibdil “↔”,darba kuljum bħala “QD”, darbtejn kuljum bħala “BID” u tliet darbiet kuljum bħala "TID").
English: Lopinavir/ritonavir Mylan is not a cure for HIV infection or AIDS - Lopinavir/ritonavir is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
Maltese: Lopinavir/ritonavir mhuwiex kura għall-infezzjoni ta' l-HIV jew għall-AIDS - Lopinavir/ritonavir jintuża minn tfal ta' sentejn jew ikbar, minn adoloxxenti u minn adulti li huma infettati bl-HIV, il-virus li jikkawża l-AIDS.
English: Paediatric populations
Maltese: Popolazzjoni Pedjatrika
English: Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg ritonavir as a pharmacokinetic enhancer.
Maltese: Kull pillola miksija b'rita fiha 100 mg ta 'lopinavir koformulata b'25 mg ta 'ritonavir bħala enhancer farmakokinetiku.
English: Children were eligible when they were aged <18 years, ≥15 kg in weight, receiving cART that included lopinavir/ritonavir, HIV-1 ribonucleic acid (RNA) <50 copies/ml for at least 24 weeks and able to swallow tablets.
Maltese: It-tfal kienu eliġibbli meta kellom inqas minn 18-il sena, kienu jiżnu 15-il kilo jew iktar, kienu qed jirċievu cART li kien jinkludi lopinavir/ ritonavir, kellhom anqas minn 50 kopja/ml ta' acidu ribonuklejku (RNA) ta' HIV-1 għal mill-inqas 24 ġimgħa u kienu kapaċi jibilgħu pilloli.
English: Lopinavir/ritonavir was not found to be mutagenic or clastogenic in a battery of in vitro and in vivo assays including the Ames bacterial reverse mutation assay, the mouse lymphoma assay, the mouse micronucleus test and chromosomal aberration assays in human lymphocytes
Maltese: F'serje sħiħa ta' analiżi in vitro u in vivo, inklużi l-analiżi Ames bacterial reverse mutation, l-analiżi tal-limfoma fil-ġurdien, it-test talmikronukleu fil-ġurdien u l-analiżi tat-telfien tal-kromosomi fil-limfoċiti umani, lopinavir/ritonavir ma' instabx li hu mutaġeniku jew klastoġeniku
English: Through Week 96, genotypic resistance testing results were available from 25 patients in the QD group and 26 patients in the BID group who had incomplete virologic response.
Maltese: Matul Ġimgħa 96, ir-riżultati tal-ittestjar għal reżistenza ġenotipika kienu disponibbli minn 25 pazjent fil-grupp QD (darba kuljum) u minn 26 pazjent fil-grupp BID (darbtejn kuljum) li kellhom rispons viroloġiku mhux komplut.
English: Oral midazolam, triazolam Increased plasma concentrations of oral midazolam and triazolam.
Maltese: Żieda fil-konċentrazzjoni fil-plażma ta' midazolam mittieħed mill-ħalq u triazolam.
English: No subject experienced an increase in QTcF of ≥ 60 ms from baseline or a QTcF interval exceeding the potentially clinically relevant threshold of 500 ms.
Maltese: L-ebda suġġett ma ġarrab żieda fil-QTcF li hi  60 ms mil-linja bażi jew intervall QTcF li jeċċedi l-limitu li hu potenzjalment klinikament rilevanti ta' 500 ms.
English: Medicinal products within class
Maltese: Prodotti mediċinali oħra
English: Hepatobiliary disorders
Maltese: Mediċini antibijotiċi
English: Erectile dysfunction, menstrual disordersamenorrhoea, menorrhagia
Maltese: Disturbi fl-erezzjoni, disturbi filmenstruazzjoni - amenorrea, menorraġia
English: The 19 isolates demonstrated a 4.3-fold increase in IC50 compared to baseline isolates (from 6.2- to 43-fold, compared to wild-type virus).
Maltese: Id-19 -il iżolat urew żieda ta' 4.3 drabi aktar f'IC50 meta mqabbla ma' iżolati tal-linja bażi (minn 6.2 sa 43 darba aktar, imqabbla ma' virus tat-tip mhux kkultivat).
English: GI motility agent
Maltese: Għeja li tinkludi astenja
English: Lopinavir/ritonavir plasma concentrations may decrease due to CYP3A4 induction by bosentan.
Maltese: Minħabba li lopinavir/ritonavir jimpedixxi CYP3A4, jista' jkun hemm żieda fil-konċentrazzjoni fil-plażma.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg ritonavir as a pharmacokinetic enhancer.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola miksija b'rita fiha 200 mg ta 'lopinavir koformulat b'50 mg ta 'ritonavir bħala enhancer farmakokinetiku.
English: Rash including maculopapular rash, dermatitis/rash including eczema and seborrheic dermatitis, night sweats, pruritus
Maltese: Raxx li jinkludi raxx makulopapulari, dermatite/raxx li jinkludi ekżema u dermatite ta' seborreja, perspirazzjoni eċċessiva bil-lejl, prurite
English: CYP3A4 inhibition likely due to lopinavir/ritonavir.
Maltese: Inibizzjoni ta' CYP3A4 x'aktarx li tiġri minħabba lopinavir/ritonavir.
English: Concomitant administration of Lopinavir/Ritonavir Mylan with fusidic acid is contra-indicated in dermatological indications due to the increased risk of adverse events related to fusidic acid, notably rhabdomyolysis (see section 4.3).
Maltese: L-għoti fl-istess ħin ta' Lopinavir/Ritonavir Mylan u cisapride hu kontraindikat, għax jista' jżid ir-riskju ta' arritmiji serji minn din is-sustanza (ara sezzjoni 4.3).
English: Trazodone single dose (Ritonavir, 200 mg BID)
Maltese: Antidipressanti u Mediċini għal kontra l-ansjetà Trazodone doża waħda (Ritonavir, 200 mg
English: Events noted as having frequency “Not known” were identified via post-marketing surveillance.
Maltese: Avvenimenti li l-frekwenza tagħhom ġiet imnizzla bħala ‘mhux magħrufa', kienu identifikati waqt sorveljanza ta' wara t-tqegħid fis-suq.
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: L-detentur tal-awtorizzazzjoni għat-tqegħid (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għattqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: In dogs, prominent U waves on the electrocardiogram have been observed associated with prolonged PR interval and bradycardia.
Maltese: Fil-klieb, fuq l-elettrokardjogramm ġew osservati mewġ prominenti tat-tip U assoċjati ma' intervall PR imtawwal u mal-bradikardija.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
Maltese: F'każ li terapiji antivirali għall-epatite B jew Ċ jittieħdu flistess waqt, jekk jogħġbok irreferi għall-informazzjoni tal-prodott rilevanti għal dawn il-prodotti mediċinali.
English: Vasodilating agents
Maltese: Pazjenti Speċjali
English: Increased risk of tumor lysis syndrome at the dose initiation and during the ramp-up phase (see section 4.5).
Maltese: Żieda fir-riskju tas-sindrome tal-lisi tat-tumur fil-bidu tad-doża u matul il-fażi ta' żieda fid-doża (ara sezzjoni 4.5).
English: Patients should be informed that nausea has been reported during treatment with lopinavir/ritonavir (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu infurmati li ġew irrappurtati każi ta' nawseja waqt il-kura b'lopinavir/ritonavir (ara sezzjoni 4.8).
English: AUC: ↑ 13-fold Due to CYP3A inhibition by lopinavir/ritonavir.
Maltese: AUC: ↑ 13-il darba Minħabba li lopinavir/ritonavir jinibixxi CYP3A.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1067/007
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1067/007
English: Subsequently, all patients were continued on the 300/75 mg per m2 dose.
Maltese: Sussegwentement il-pazjenti kollha komplew fuq id-doża 300/75 mg kull m2.
English: Safety, efficacy and pharmacokinetic profiles of the two dose regimens were assessed after 3 weeks of therapy in each patient.
Maltese: Sigurta', effikaċja u l-profili farmakokinetiċi tażżewġ dużaġġi kienu analiżati wara 3 ġimgħat terapija f'kull pazjent.
English: Due to CYP3A inhibition by lopinavir/ritonavir.
Maltese: Minħabba l-inibizzjoni ta' CYP3A b' lopinavir/ritonavir.
English: Bosentan
Maltese: Dronedarone
English: It is important to note that cases of pancreatitis have been reported in patients receiving lopinavir/ritonavir, including those who developed hypertriglyceridaemia.
Maltese: Huwa importanti li ninutaw li każi ta' pankreatite ġew rappurtati f'pazjenti li qed jieħdu lopinavir/ritonavir, inklużi dawk li żvillupaw ipertrigliċeridemija.
English: Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with Lopinavir/Ritonavir Mylan.
Maltese: Rakkomandazzjoni klinika dwar l-għoti ta' prodotti mediċinali oħra flimkien ma' Lopinavir/Ritonavir Mylan
English: AUC: ↑ 3-fold Cmax: ↑ 1.8-fold
Maltese: AUC: ↑ 5 darbiet Cmax: ↑ 6 darbiet
English: Lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years.
Maltese: Lopinavir/ritonavir huwa indikat flimkien ma' aġenti antiretrovirali oħra, għall-kura ta' tfal ta' 'il fuq minn sentejn, ta' adoloxxenti u ta' adulti, li huma nfettati bil- human immunodeficiency virus (HIV-1).
English: Do not take Lopinavir/Ritonavir Mylan if: - you are allergic to lopinavir, ritonavir or any of the other ingredients of this medicine (listed in section 6); - you have severe liver problems.
Maltese: Tiħux Lopinavir/Ritonavir Mylan jekk: - int allerġiku/a għal lopinavir, ritonavir jew sustanzi oħra ta 'din il-mediċina (elenkati fis sezzjoni 6); - int għandek problemi serji ħafna tal-fwied.
English: Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg ritonavir as a pharmacokinetic enhancer.
Maltese: Kull pillola miksija b'rita fiha 200 mg ta 'lopinavir koformulata b'50 mg ta 'ritonavir bħala enhancer farmakokinetiku.
English: Lopinavir/Ritonavir Mylan must not be co-administered with oral midazolam (see section 4.3), whereas caution should be used with coadministration of Lopinavir/Ritonavir Mylan and parenteral midazolam.
Maltese: Lopinavir/Ritonavir Mylan huwa kkunsidrat neċessarju, huwa rrakkomandat monitoraġġ ta' ECG frekwenti ħafna matul ilperjodu kollu tat-trattament ta' delamanid (ara sezzjoni 4.4 u rreferi għall-SmPC ta' delamanid).
English: The frequency of this is unknown (see section 4.4).
Maltese: Il-frekwenza ta' dan mhux magħrufa (ara sezzjoni 4.4).
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Maltese: Barra min infezzjonijiet opportunistiċi, jista' ikun hemm disturbi awtoimmunitarji (kundizzjoni li sseħħ meta is-sistema immunitarja tattakka tessuti b'saħħithom tal-ġisem) wara li tbda tieħu mediċini għat-trattament tal-infezzjoni tal-HIV tiegħek.
English: − anti-gout medicines (e.g. colchicine).
Maltese: Dawn il-prodotti mediċinali jinkludu:
English: Sustained virological response to lopinavir/ritonavir (in combination with nucleoside/nucleotide reverse transcriptase inhibitors) has been also observed in a small Phase II study (M97-720) through 360 weeks of treatment.
Maltese: Respons viroloġiku sostnut b'lopinavir/ritonavir (flimkien ma ' inibituri ta ' nucleoside/nucleotide reverse transcriptase) ġie osservat ukoll fi studju żgħir ta ' Fażi
English: Pharmacotherapeutic group: Corticosteroids.
Maltese: Kategorija farmakoterapewtika: Corticosteroids.
English: Alisade contains benzalkonium chloride.
Maltese: Alisade fih benzalkonium chloride.
English: *Epistaxis
Maltese: * Epistassi
English: Sími: + 354 530 3700
Maltese: Tel: + 354 530
English: Clinical experience:
Maltese: Esperjenza klinika:
English: The following convention has been used for the classification of frequencies: Very common >1/10; Common >1/100 to <1/10; Uncommon >1/1000 to <1/100; Rare >1/10,000 to <1/1000; Very rare
Maltese: Komuni ħafna >1/10; Komuni >1/100 sa <1/10; Mhux komuni >1/1000 sa <1/100;
English: Glaxo Group Ltd Greenford, Middlesex, UB6 0NN United Kingdom
Maltese: Glaxo Group Ltd Greenford, Middlesex, UB6 0NN
English: • ritonavir, used to treat HIV
Maltese: • ritonavir, li jintuża għat-trattament ta' l-HIV
English: Alisade belongs to a group of medicines called glucocorticoids.
Maltese: Alisade jiforma parti mill-grupp ta' mediċini msejħa glucocorticoids.
English: *Epistaxis was generally mild to moderate in intensity.
Maltese: *Epistassi kienet ġeneralment ħafifa sa moderata f'dik li hi intensita`.
English: In a drug interaction study of intranasal fluticasone furoate with the potent CYP3A4 inhibitor ketoconazole there were more subjects with measurable fluticasone furoate concentrations in the ketoconazole group (6 of the 20 subjects) compared to placebo (1 out of 20 subjects).
Maltese: Fi studju dwar interazzjoni ta' fluticasone furoate fl-imnieħer bl-inibitur potenti CYP3A4 ketoconazole, kien hemm aktar suġġetti b'konċentrazzjonijiet jitkejlu ta' fluticasone furoate fil-grupp ketoconazole (6 minn 20 suġġett) meta mqabbla ma' dawk bi plaċebo (1 minn 20 suġġett).
English: However, it is usually effective within 8 to 24 hours of use.
Maltese: normalment ikun effettiv wara 8 sa 24 siegħa li jkun ġie wżat.
English: Manufacturer:
Maltese: Distribuzzjoni:
English: Perennial Allergic Rhinitis in adults and adolescents:
Maltese: Rinite Allerġika ta' l-Istaġun f'adulti u adolexxenti
English: A study of a single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate hepatic impairment resulted in increased Cmax (42 %) and AUC(0-∞) (172 %) and a modest (on average 23 %) decrease in cortisol levels in patients compared to healthy subjects.
Maltese: Studju fuq doża waħda ta' 400 mikrogrammi ta' fluticasone furoate meħuda mill-ħalq minn pazjenti b'indeboliment moderat tal-fwied wera żieda ta' Cmax (42 %) u AUC(0-∞) (172 %) u tnaqqis moderat (medja ta' 23 %) fil-livelli ta' kortisol fil-pazjenti meta mqabbla ma' suġġetti f'saħħithom.
English: The principal route of metabolism was hydrolysis of the Sfluoromethyl carbothioate function to form the 17β-carboxylic acid metabolite.
Maltese: Ir-rotta prinċipali ta' metaboliżmu kienet l-idrolisi tal-funzjoni S-fluoromethyl carbothioate biex tifforma l-metabolit 17β-carboxylic acid.
English: Hepatic Impairment:
Maltese: Sintomi jinkludu:
English: Metabolism: Fluticasone furoate is rapidly cleared (total plasma clearance of 58.7 l/h) from systemic circulation principally by hepatic metabolism to an inactive 17β-carboxylic metabolite (GW694301X), by the cytochrome P450 enzyme CYP3A4.
Maltese: Fluticasone furoate jitneħħa malajr (tneħħija totali ta' 58.7 l/s ta' plażma) miċċirkolazzjoni sistemika prinċipalment b'metaboliżmu tal-fwied għal metabolit 17β-carboxylic mhux attiv (GW694301X), bl-enzima CYO3A4 taċ-ċitokromu P450.
English: Also contains: Glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water
Maltese: Fih ukoll: Glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, ilma purifikat
English: Only a small number of elderly patients (≥ 65 years, n=23/872; 2.6 %) provided pharmacokinetic data.
Maltese: Ħareġ tagħrif farmakokinetiku minn numru tassew żgħir ta' pazjenti anzjani (≥ 65 sena, n=23/872; 2.6 %).
English: PHARMACEUTICAL FORM Nasal spray, suspension.
Maltese: Sprej ta' l-imnieħer, suspensjoni.
English: Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Maltese: Reazzjonijiet ta' sensittività eċċesiva inkluż anafilassi, anġjoedima, raxx,