FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents Clopidogrel Acino Pharma GmbH is not intended for use in children or adolescents.
Maltese: Tfal u adolexxenti Clopidogrel Acino Pharma GmbH m'għandux jingħata lit-tfal jew lill-adolexxenti.
English: BEFORE YOU TAKE CLOPIDOGREL ACINO PHARMA GMBH
Maltese: X'fih Clopidogrel Acino Pharma GmbH
English: Clopidogrel Acino Pharma GmbH is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Maltese: GmbH jittieħed biex inaqqas ir-riskju li emboli tad-demm (trombi) jifformaw fl-arterji mwebbsin (arterji), proċess imsejjaħ aterotrombosi, li jista' jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
English: • If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Acino Pharma GmbH;
Maltese: • Jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għall-clopidogrel jew sustanzi oħra ta' Clopidogrel Acino Pharma
English: What Clopidogrel Acino Pharma GmbH looks like and contents of the pack
Maltese: Id-Dehra ta' Clopidogrel Acino Pharma GmbH u l-kontenuti tal-pakkett
English: INFORMATION IN BRAILLE Clopidogrel Acino Pharma GmbH 75 mg
Maltese: QABEL MA TIEĦU CLOPIDOGREL ACINO PHARMA GMBH
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Acino Pharma GmbH 75 mg film-coated tablets Clopidogrel NAME OF THE MARKETING AUTHORISATION HOLDER Acino Pharma GmbH EXPIRY DATE
Maltese: Id-doża normali hija ta' pillola waħda ta' 75 mg Clopidogrel Acino Pharma
English: Clopidogrel Acino Pharma GmbH 75 mg film-coated tablets are white to off-white, marbled, round and biconvex.
Maltese: Pillola miksija b'rita Pilloli miksija b'rita, bojod sa bojod jagħtu fil-griż, qishom irħam, tondi u bikonvessi.
English: If you experience prolonged bleeding when taking Clopidogrel Acino Pharma GmbH.
Maltese: TAD-DETENTUR TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Acino Pharma GmbH
English: If you forget to take Clopidogrel Acino Pharma GmbH If you forget to take a dose of Clopidogrel Acino Pharma GmbH, but remember within 12 hours of your usual time, take your tablet straight away and then take your next tablet at the usual time.
Maltese: Jekk toħroġ tqila waqt li qiegħda tieħu Clopidogrel Acino Pharma GmbH, għarraf minnufih lit-tabib tiegħek billi huwa rrakkomandat li ma tieħux clopidrogrel waqt it-tqala.
English: Open date: __________
Maltese: Data ta' ftuħ: __________
English: Dexamethasone (systemic)
Maltese: Dexamethasone (sistemiku)
English: 95% confidence intervals.
Maltese: Intervalli ta' kunfidenza ta' 95%.
English: Midazolam (oral) Triazolam
Maltese: Midazolam (orali) Triazolam
English: Treatment difference (95% CI of difference)
Maltese: Differenza fil-kura (95% CI tad-differenza)
English: 400 copies/ml) b IAS-USA lists
Maltese: < 400 kopja/ml) b IAS-listi tal-USA
English: [On carton only:] Open date: __________
Maltese: [Fuq il-kartuna biss:] Data ta' ftuħ: __________
English: Midazolam (parenteral) Zoldipem
Maltese: Midazolam (parenterali) Zoldipem
English: Lidocaine (systemic) Mexiletine Propafenone
Maltese: Lidocaine (sistemiku) Mexiletine
English: Tenofovir disoproxil 245 mg once daily‡
Maltese: Tenofovir disoproxil 245 mg darba kuljum‡
English: SEDATIVES/HYPNOTICS Buspirone
Maltese: SEDATTIVI/IPNOTIĊI Buspirone
English: 675 milligram
Maltese: 675 milligramma
English: Clades A1, D, F1, G, K, CRF02_AG, CRF12_BF, and CRF06_CPX
Maltese: Gruppi ta' virusis ġejjin mill-istess antenat A1, D, F1, G, K, CRF02_AG, CRF12_BF, u CRF06_CPX d Differenza fil-medji e
English: Infections and infestations Uncommon herpes simplex
Maltese: Infezzjonijiet u infestazzjonijiet Mhux komuni herpes simplex
English: Date of first authorisation: 4th January 2017
Maltese: 4 Jannar 2017
English: Mylan Hungary Kft Mylan utca 1, Komárom, 2900, Hungary
Maltese: Mylan utca 1, Komárom, 2900, L-Ungerija
English: Difference in means e
Maltese: Differenza fil-medji e
English: Latvija*
Maltese: Lietuva*
English: Adverse reactions are listed by system organ class (SOC) and frequency category.
Maltese: Ir-reazzjonijiet avversi huma elenkati skond is-sistema tal-klassifika ta' l-organi (SOC) u l-kategorija ta' frekwenza.
English: PI RAMs
Maltese: * DRV-RAMs:
English: - Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels).
Maltese: - Atorvastatin, pravastatin, rosuvastatin (biex tnaqqas il-livelli ta' kolesterol fid-demm).
English: 800 milligram
Maltese: 800 milligramma
English: AUC24h, ng.h/mL 47,293 ± 19,058
Maltese: AUC24h, ng.siegħa/mL 47,293 ± 19,058 47,991 ± 9,879 Cmin, ng/mL
English: GS-US-216-130 Week 48
Maltese: GS-US-216-130 Ġimgħa 48
English: Silica, colloidal anhydrous Cellulose microcrystalline Crospovidone Sodium starch glycolate Hypromellose Magnesium stearate
Maltese: Qalba tal-pillola Silica, colloidal anhydrous Cellulose microcrystalline Crospovidone Sodium starch glycolate Hypromellose Magnesium stearate
English: - Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Maltese: - Kortikosterojdi inkluż betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
English: - Oestrogen-based hormonal contraceptives and hormonal replacement therapy.
Maltese: - Kontraċettivi ormonali b'bażi ta' estroġenu u terapija ta' sostituzzjoni tal-ormoni.
English: 600 milligram
Maltese: 600 milligramma
English: Cmax, ng/ml AUC12h, ng.h/ml Cmin, ng/ml a n=11 for AUC12h
Maltese: Cmax, ng/ml AUC12-il siegħa, ng.siegħa/ml Cmin, ng/ml a n=11 għal AUC12-il siegħa
English: Cmax, ng/ml AUC24h, ng.h/ml Cmin, ng/ml
Maltese: Cmax, ng/ml AUC24 siegħa, ng.siegħa/ml Cmin, ng/ml
English: Patients co-infected with hepatitis B and/or hepatitis C virus
Maltese: Pazjenti ko-infettati bil-virus tal-epatite B u/jew Ċ
English: What is Darunavir Mylan?
Maltese: X'inhu Darunavir Mylan?
English: Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 x 10
Maltese: Darunavir huwa impeditur tad-dimerizzazzjoni u l-attività katalittika ta' l- HIV-1 protease (KD ta' 4.5 x 10
English: Carbamazepine 200 mg twice daily carbamazepine AUC ↑ 45% carbamazepine Cmin ↑ 54% carbamazepine Cmax ↑ 43% darunavir AUC ↔ darunavir Cmin ↓ 15% darunavir Cmax ↔
Maltese: Carbamazepine 200 mg darbtejn kuljum carbamazepine AUC ↑ 45% carbamazepine Cmin ↑ 54% carbamazepine Cmax ↑ 43% darunavir AUC ↔ darunavir Cmin ↓ 15% darunavir Cmax ↔
English: • Risk management plan (RMP)
Maltese: ● Pjan tal-ġestjoni tar-riskju (RMP)
English: Gastrointestinal disorders Very common
Maltese: Disturbi gastrointestinali Komuni ħafna dijarea
English: 100 milligram between 30 and 40 kilograms
Maltese: 100 milligramma bejn 30 u 40 kilogramma
English: Colchicine (if you have kidney and/or liver problems)
Maltese: Colchicine (jekk inti għandek problemi fil-kliewi u/jew fil-fwied)
English: Darunavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M (A, B, C, D, E, F, G) and group O primary isolates with EC50 values ranging from < 0.1 to 4.3 nM.
Maltese: Darunavir juri attività antivirali in vitro kontra sezzjoni wiesa' ta' ċelluli puri talvirusis iżolati primarjament ta' HIV-1 grupp M (A, B, C, D, E, F, G) u grupp O b'valuri EC50 minn < 0.1 to 4.3 nM.
English: angioedema, pruritus, urticaria drug reaction with eosinophilia and systemic symptoms*, Stevens-Johnson syndrome*
Maltese: Rari reazzjoni għall-mediċina b'eosinofilja u sintomi sistemiċi *, sindrome ta' Stevens-Johnson*
English: ≥ 30 kg to < 40 kg
Maltese:  30 kg sa < 40 kg
English: (-4.6; 9.2)d d d
Maltese: (-5.2; 7.9)d
English: 100 milligram a ritonavir oral solution: 80 milligram per milliliter
Maltese: 100 milligramma a soluzzjoni orali ta' ritonavir: 80 milligramma f'kull millilitru
English: Rifabutin 150 mg once every other day rifabutin AUC** ↑ 55% rifabutin Cmin
Maltese: 150 mg ġurnata iva u oħra le rifabutin AUC** ↑ 55% rifabutin Cmin
English: 150 mg once every other day rifabutin AUC rifabutin Cmin
Maltese: Rifabutin 150 mg ġurnata iva u oħra le rifabutin AUC rifabutin Cmin
English: CORTICOSTEROIDS Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone)
Maltese: KORTIKOSTEROJDI Kortikosterojdi mmetabolizzati primarjament minn CYP3A (inkluż betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone)
English: NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE Methadone individual dose ranging from 55 mg to 150 mg once daily
Maltese: ANALĠEŻIĊI NARKOTIĊI/KURA TA' DIPENDENZA FUQ L-OPJOJDI Methadone doża individwali fuq firxa minn 55 mg sa 150 mg darba kuljum
English: ANTIANGINA/ANTIARRHYTHMIC Disopyramide
Maltese: ANTIANĠINA/ANTIARRITMIĊI Disopyramide
English: HIV RNA < 50 copies/ml a
Maltese: HIV RNA < 50 kopja/ml a
English: DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and Stevens-Johnson syndrome has been rarely (< 0.1%) reported, and during post-marketing experience toxic epidermal necrolysis and acute generalised exanthematous pustulosis have been reported.
Maltese: DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) u s-sindrome ta' Stevens-Johnson kien irrappurtat b'mod rari (< 0.1%), u waqt l-esperjenza ta' wara t-tqegħid fis-suq ġew irrappurtati nekroliżi epidermali tossika u reazzjoni akuta ta' bżieżaq b'materja mifruxa.
English: (CYP3A and OATP1B inhibition).
Maltese: (inibizzjoni ta' CYP3A u OATP1B).
English: #darunavir AUC ↓ 26% darunavir Cmin ↓ 42% #darunavir Cmax ↓ 17% saquinavir AUC ↓ 6% saquinavir Cmin ↓ 18% saquinavir Cmax ↓ 6%
Maltese: Saquinavir 1,000 mg darbtejn kuljum darunavir AUC ↓ 26% #darunavir Cmin ↓ 42% darunavir Cmax ↓ 17% saquinavir AUC ↓ 6% saquinavir Cmin ↓ 18% saquinavir Cmax ↓ 6%
English: DRESS, Stevens-Johnson syndrome, erythema multiforme, dermatitis, seborrhoeic dermatitis, skin lesion, xeroderma toxic epidermal necrolysis, acute generalised exanthematous pustulosis
Maltese: DRESS, sindrome ta' Stevens-Johnson, eritema multiforme, dermatite, dematite tas-saborrea, ġerħa fil-ġilda, kserodema.
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 jkun diġà qed jieħu St John's wort, waqqaf isSt John's wort u jekk possibbli iċċekkja l-livelli virali.
English: 150 mg twice daily darunavir AUC ↔ #darunavir Cmin ↔ darunavir Cmax ↔
Maltese: 20 mg darba kuljum darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
English: Digoxin 0.4 mg single dose digoxin AUC ↑ 61% digoxin Cmin ND digoxin Cmax ↑ 29% (↑ digoxin from probable inhibition of P-gp)
Maltese: Digoxin Doża waħda ta' 0.4 mg digoxin AUC ↑ 61% digoxin Cmin ND digoxin Cmax ↑ 29% (↑ digoxin x'aktarx minn impediment ta' P-gp)
English: Do not combine darunavir with products that contain St John's wort (Hypericum perforatum).
Maltese: Tikkombinax darunavir ma' prodotti li fihom St John's wort (Hypericum perforatum).
English: Lopinavir/ritonavir 533/133.3 mg twice daily lopinavir AUC ↑ 9% lopinavir Cmin ↑ 23% lopinavir Cmax ↓ 2% darunavir AUC ↓ 38%‡
Maltese: Lopinavir/ritonavir 533/133.3 mg darbtejn kuljum lopinavir AUC ↑ 9% lopinavir Cmin ↑ 23% lopinavir Cmax ↓ 2% darunavir AUC ↓ 38%‡
English: e d a
Maltese: d a
English: rifabutin Cmax darunavir AUC ↑ 53% darunavir Cmin ↑ 68%
Maltese: rifabutin Cmax darunavir AUC ↑ 53% darunavir Cmin ↑ 68% darunavir Cmax ↑ 39%
English: Darunavir and ritonavir are inhibitors of CYP3A, CYP2D6 and P-gp.
Maltese: Darunavir u ritonavir huma impedituri ta' CYP3A, CYP2D6 u P-gp.
English: After a 400/100 mg
Maltese: 400/100 mg darbtejn kuljum
English: Indinavir 800 mg twice daily indinavir AUC ↑ 23% indinavir Cmin ↑ 125% indinavir Cmax ↔ #darunavir AUC ↑ 24% darunavir Cmin ↑ 44% #darunavir Cmax ↑ 11%
Maltese: Indinavir 800 mg darbtejn kuljum indinavir AUC ↑ 23% indinavir Cmin ↑ 125% indinavir Cmax ↔ darunavir AUC ↑ 24% #darunavir Cmin ↑ 44% darunavir Cmax ↑ 11%
English: ● antiretroviral therapy (ART)-naïve (see section 4.2).
Maltese: • qatt ma ħadu kura b'antiretrovirali (ART), qabel (ara sezzoni 4.2).
English: ≥ 30 kg-< 40 kg 675 mg darunavir/100 mg ritonavir once daily
Maltese: ≥ 30 kg-< 40 kg 675 mg darunavir/100 mg ritonavir darba kuljum
English: With Baseline CD4+ cell count (x 106/l)
Maltese: B'għadd ta' ċelluli CD4+ (x 106/l)
English: ≥ 15 kg to < 30 kg
Maltese:  15 kg sa < 30 kg
English: It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles.
Maltese: Huwa selettivament jimpedixxi l-qasma ta' poliproteini Gag-Pol li fihom ilkowd ta' l-HIV fiċ-ċelluli infettati bil-virus, u permezz t'hekk ifixkel il-formazzjoni ta' biċċiet infettivi maturi tal-virus.
English: Darunavir is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection.
Maltese: Darunavir huwa mediċina antiretrovirali użat għattrattament ta' infezzjoni bil-Virus Uman ta' l-Immunodefiċjenza (HIV).
English: 600 mg once daily efavirenz AUC ↑ 21% efavirenz Cmin ↑ 17% efavirenz Cmax ↑ 15% darunavir AUC ↓ 13% #darunavir Cmin ↓ 31% darunavir Cmax ↓ 15% (↑ efavirenz from CYP3A inhibition) (↓ darunavir from CYP3A induction)
Maltese: 600 mg darba kuljum efavirenz AUC ↑ 21% efavirenz Cmin ↑ 17% efavirenz Cmax ↑ 15% darunavir AUC ↓ 13% darunavir Cmin ↓ 31% darunavir Cmax ↓ 15% (↑ efavirenz minn impediment ta' CYP3A) (↓ darunavir minn induzzjoni ta' CYP3A)
English: The table below shows the development of HIV-1 protease mutations and resistance to PIs in virologic failures at endpoint in the GS-US-216-130 trial.
Maltese: It-tabella taħt turi l-iżvilupp ta' mutazzjonijiet ta' protease ta' HIV-1 u reżistenza għal PIs f'fallimenti viroloġiċi fil-punt finali talprova GS-US-216-130.
English: Fluticasone: in a clinical study where ritonavir 100 mg capsules twice daily were co-administered with 50 μg intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, fluticasone propionate plasma concentrations increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% CI 8289%).
Maltese: Fluticasone: fi studju kliniku fejn kapsuli ta' 100 mg ritonavir darbtejn kuljum ingħataw flimkien ma' 50 µg fluticasone propionate mogħti ġol-imnieħer (4 darbiet kuljum) għal 7 ijiem f'pazjenti b'saħħithom, il-konċentrazzjonijiet ta' fluticasone propionate fil-plażma żdiedu b'mod sinifikanti filwaqt li l-livelli intrinsiċi tal-cortisol naqsu b'bejn wieħed u ieħor 86% (90% CI 82 - 89%).
English: ethinylestradiol AUC ↓ 44% β ethinylestradiol Cmin ↓ 62% β
Maltese: Cmin ta' ethinylestradiol ↓ 62%β Cmax ta' ethinylestradiol ↓ 32%
English: Darunavir was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation (Ames), chromosomal aberration in human lymphocytes and in vivo micronucleus test in mice.
Maltese: Darunavir ma kienx mutaġeniku jew ġenotossiku f'għadd ta' analiżi in vitro u in vivo inkluż mutazzjoni batterjali bil-kuntrarju (Ames), aberrazzjoni tal-kromożomi fil-limfoċit uman u t-test in vivo tal-mikronukleju fil-ġrieden.
English: The following patient populations were evaluated (see section 5.1):
Maltese: Il-popolazzjonijiet ta' pazjenti li ġejjin ġew evalwati (ara s-sezzjoni 5.1):
English: UROLOGICAL DRUGS Fesoterodine
Maltese: MEDIĊINI UROLOĠIĊI Fesoterodine
English: Darunavir Mylan contains the active substance darunavir.
Maltese: Darunavir Mylan fih is-sustanza attiva darunavir.
English: Medicinal products that may be affected by darunavir boosted with cobicistat The recommendations for darunavir boosted with ritonavir are adequate also for darunavir boosted with cobicistat with regard to substrates of CYP3A4, CYP2D6, P-glycoprotein, OATP1B1 and OATP1B3 (see contraindications and recommendations presented in the section above).
Maltese: Ir-rakkomadazzjonijiet għal darunavir intensifikat b'ritonavir huma adegwati anke għal darunavir intensifikat b'cobicistat għal dawk li huma sustrati ta' CYP3A4, CYP2D6, glikoproteina P, OATP1B1 u OATP1B3 (ara kontraindikazzjonijiet u rakkomandazzjonijiet ippreżentati fis-sezzjoni fuq).
English: During the Phase III clinical trial GS-US-216-130 with darunavir/cobicistat (N=313 treatment-naïve and treatment-experienced subjects), 66.5% of subjects experienced at least one adverse reaction.
Maltese: III tal-prova klinika GS-US-216-130 b'darunavir/cobicistat (N=313-il individwu li qatt ma ħadu kura qabel u li kienu diġà ħadu kura qabel), 66.5% tal-individwi kellhom mill-inqas reazzjoni avversa waħda.
English: Rosuvastatin 10 mg once daily rosuvastatin AUC ↑ 48%║ rosuvastatin Cmax ↑ 144% ║ based on published data with darunavir/ritonavir
Maltese: Rosuvastatin 10 mg darba kuljum rosuvastatin AUC ↑ 48%║ rosuvastatin Cmax ↑ 144% ║ ibbażat fuq dejta publikata b'darunavir/ritonavir
English: ‡ Study was conducted with tenofovir disoproxil fumarate 300 mg once daily.
Maltese: L-istudju sar b'tenofovir disoproxil fumarate 300 mg darba kuljum.
English: During the darunavir/ritonavir clinical development program (N=3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with darunavir/ritonavir.
Maltese: Waqt il-programm ta' żvilupp kliniku (N=3,063) ta' darunavir/ritonavir, l-epatite kienet irrappurtata f'0.5% tal-pazjenti li kienu qed jirċievu terapija antiretrovirali mħallta bi darunavir/ritonavir.
English: Concomitant use of darunavir/ritonavir and darunavir/cobicistat with lopinavir/ritonavir, rifampicin and herbal products containing St John's wort, Hypericum perforatum, is contraindicated (see section 4.5).
Maltese: L-użu ta' darunavir/ritonavir u darunavir/cobicistat flimkien ma' lopinavir/ritonavir, rifampicin u prodotti magħmula mill-ħxejjex li fihom St John's wort, Hypericum perforatum, huwa kontraindikat (ara sezzjoni 4.5).
English: Following intravenous administration, the volume of distribution of darunavir alone was 88.1 ± 59.0 l (Mean ± SD) and increased to 131 ± 49.9 l (Mean ± SD) in the presence of 100 mg twice-daily ritonavir.
Maltese: Wara amministrazjoni fil-vini, il-volum ta' distribuzzjoni ta' darunavir waħdu kien ta' 88.1 ± 59.0 l (Medja ± SD) u żdied għal 131 ± 49.9 l (Medja ± SD) fil-preżenza ta'100 mg ritonavir darbtejn kuljum.
English: The table below shows the efficacy data of the 48 week analyses from the GS-US-216-130 trial:
Maltese: It-tabella taħt turi d-dejta ta' effikaċja tal-analiżi tal-ġimgħa 48 mill-prova GS-US-216-130:
English: OESTROGEN-BASED CONTRACEPTIVES Drospirenone Ethinylestradiol (3 mg/0.02 mg once daily)
Maltese: Drospirenone Ethinylestradiol (3 mg/0.
English: Population pharmacokinetic analysis in HIV infected patients showed that darunavir pharmacokinetics are not considerably different in the age range (18 to 75 years) evaluated in HIV infected patients (n=12, age ≥ 65) (see section 4.4).
Maltese: Analiżi farmakokinetika ta' popolazzjoni f'pazjenti infettati bl-HIV uriet li l-farmakokinetika ta' darunavir m'hijiex konsiderevolment differeni fil-medda ta' l-eta'(18 sa 75 sena) evalwati f'pazjenti infettati bl-HIV (n=12, età  65) (ara sezzjoni 4.4).
English: 25-O-desacetylrifabutin.
Maltese: J05AE10.
English: Darunavir Mylan 75 mg film-coated tablets Darunavir Mylan 150 mg film-coated tablets Darunavir Mylan 300 mg film-coated tablets Darunavir Mylan 600 mg film-coated tablets
Maltese: Darunavir Mylan 75 mg pilloli miksijin b'rita Darunavir Mylan 150 mg pilloli miksijin b'rita Darunavir Mylan 300 mg pilloli miksijin b'rita Darunavir Mylan 600 mg pilloli miksijin b'rita
English: Darunavir FC was less than 10 for 90% of 3,309 clinical isolates resistant to amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir and/or tipranavir showing that viruses resistant to most PIs remain susceptible to darunavir.
Maltese: L-FC ta' darunavir kien anqas minn 10 għal 90% minn 3,309 virusis iżolati klinikament reżistenti għal amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir u/jew tipranavir li juri li lvirusis reżistenti għall-maġġoranza tal-PIs jibqgħu suxxettibbli għal darunavir.
English: Cobicistat 150 mg given with darunavir 800 mg once daily enhances darunavir pharmacokinetic parameters in a comparable way to ritonavir (see section 5.2).
Maltese: Cobicistat 150 mg mogħti ma' darunavir 800 mg darba kuljum jintensifika l-parametri farmakokinetiċi b'mod kumparabbli għal ritonavir (ara sezzjoni 5.2).
English: Atorvastatin 10 mg once daily atorvastatin AUC ↑ 3-4 fold atorvastatin Cmin ↑ ≈5.5-10 fold atorvastatin Cmax ↑ ≈2 fold #darunavir/ritonavir atorvastatin AUC ↑ 290% Ω
Maltese: Atorvastatin 10 mg darba kuljum atorvastatin AUC ↑ 3-4 drabi aktar atorvastatin Cmin ↑ ≈5.5-10 drabi aktar atorvastatin Cmax ↑ ≈2 drabi aktar darunavir/ritonavir atorvastatin AUC ↑ 290%
English: - Clarithromycin (antibiotic) - Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as the therapeutic effect or side effects of these medicines might be increased.
Maltese: - Clarithromycin (antibijotiku) - Ciclosporin, everolimus, tacrolimus, sirolimus (biex titnaqqas il-qawwa tas-sistema immuni tiegħek) minħabba li l-effett terapewtiku jew l-effetti sekondarji ta' dawn il-mediċini jistgħu jiżdiedu.
English: GS-US-216-130 is a single arm, open-label, Phase III trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with cobicistat in 313 HIV-1 infected adult patients (295 treatment-naïve and 18 treatment-experienced).
Maltese: GS-US-216-130 hija prova tal-Fażi III, open-label, b'fergħa waħda biex tistma l-farmakokinetika, issigurtà, it-tollerabbiltà u l-effikaċja ta' darunavir ma' cobicistat fi 313-il pazjent adult infettat blHIV-1 (295 li qatt ma ħadu kura qabel u 18 li diġà kienu ħadu kura qabel).
English: See the Summary of Product Characteristics for darunavir 75 mg, 150 mg, 300 mg and 600 mg tablets (see section 4.5).
Maltese: Ara s-Sommarju tal-Karattersitiċi talProdott għall-pilloli darunavir 75 mg, 150 mg, 300 mg u 600 mg (ara sezzjoni 4.5).
English: After day 23 of life, the exposure was comparable to that in adult rats.
Maltese: Wara t-23 jum ta' ħajja, lesponiment kien komparabbli ma dak ta' firien adulti.
English: Number of baseline mutations a
Maltese: b mill-linja bażi a
English: - The other ingredients are colloidal anhydrous silica, cellulose microcrystalline, crospovidone,
Maltese: - Is-sustanzi l-oħra huma colloidal anhydrous silica, cellulose microcrystalline, crospovidone,
English: Metabolism and nutrition disorders Common anorexia, diabetes mellitus, hypercholesterolaemia, hypertriglyceridaemia, hyperlipidaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni anoressija, dijabete mellitus, iperkolesterolemija, ipertrigliċeridemija, iperlipidemija
English: <PVC/PE/PVDC-Al blister pack only> Do not store above 25°C.
Maltese: <Pakkett bil-folji tal-PVC/PE/PVDC-Al biss> Taħżinx f'temperatura 'l fuq minn 25°C.
English: HIV ANTIRETROVIRALS Integrase strand transfer inhibitors Dolutegravir dolutegravir AUC ↓ 22% dolutegravir C24h ↓38% dolutegravir Cmax ↓ 11% darunavir ↔* * Using cross-study comparisons to historical pharmacokinetic data
Maltese: HIV Impedituri ta' integrase strand transfer Dolutegravir dolutegravir AUC ↓ 22% dolutegravir C24h ↓ 38% dolutegravir Cmax ↓ 11% darunavir ↔*
English: Medicinal products that may be affected by darunavir boosted with ritonavir Darunavir and ritonavir are inhibitors of CYP3A, CYP2D6 and P-gp.
Maltese: Prodotti mediċinali li jistgħu jiġu affettwati minn darunavir intensifikat b'ritonavir Darunavir u ritonavir huma impedituri ta' CYP3A, CYP2D6 u P-gp.
English: 100 milligram more than 40 kilograms
Maltese: 100 milligramma aktar minn 40 kilogramma
English: Co-administration of boosted darunavir and amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine is contraindicated (see section 4.3).
Maltese: Darunavir intensifikat mogħti flimkien ma' amiodarone, bepridil, dronedarone, ivabradine, quinidine, jew ranolazine huwa kontraindikat (ara sezzjoni 4.3).