FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effect with Filgrastim Hexal (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Maltese: L-effett sekondarju l-aktar komuni b'Filgrastim Hexal (li deher f'iktar minn pazjent wieħed minn kull għaxra) hu wġiegħ muskoloskeletali (uġigħ fil-muskoli u fl-għadam).
English: EU/1/16/1130/001
Maltese: EU/1/16/1130/001 ONIVYDE lipożomali pegilat
English: 4.3 mg/ml Concentrate for solution for infusion
Maltese: 4.3 mg/mL Konċentrat għal soluzzjoni għall-infużjoni
English: ONIVYDE pegylated liposomal
Maltese: Mnejn għandu jingħata
English: EMA/CHMP/149365/2011 EMEA/H/C/002356
Maltese: EMA/149365/2011 EMEA/H/C/002356
English: The full EPAR for Leflunomide Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Leflunomide Teva jista' jiġi kkonsultat fis-sit elettoniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Leflunomide Teva to TEVA Pharma B.V. on 10 March 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Leflunomide Teva lil TEVA Pharma B.V. fl-10 ta' Marzu 2011.
English: Leflunomide Teva is a ‘generic medicine'.
Maltese: Leflunomide Teva huwa ‘mediċina ġenerika'.
English: The active substance in Leflunomide Teva, leflunomide, is an immunosuppressant.
Maltese: Is-sustanza attiva f'Leflunomide Teva, leflunomide, hija immunosuppressiv.
English: It is available as tablets (white and round: 10 mg; dark beige and triangular: 20 mg).
Maltese: Jiġi bħala pilloli (bojod u tondi: 10 mg; beġ skur u f'għamla triangolari: 20 mg).
English: The recommended maintenance dose is 10 to 20 mg once a day.
Maltese: Id-doża rakkomandata hija ta' 10 sa 20 mg darba kuljum.
English: Leflunomide Teva EMA/CHMP/149365/2011
Maltese: EMA/149300/2011
English: This is a summary of the European public assessment report (EPAR) for Leflunomide Teva.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Leflunomide Teva.
English: The CHMP concluded that, in accordance with EU requirements, Leflunomide Teva has been shown to have comparable quality and to be bioequivalent to Arava.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Leflunomide Teva wera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Arava.
English: Leflunomide Teva is a medicine that contains the active substance leflunomide.
Maltese: Leflunomide Teva huwa mediċina li fiha s-sustanza attiva leflunomide.
English: Leflunomide Teva is used to treat adults with active rheumatoid arthritis (an immune system disease
Maltese: Leflunomide Teva jintuża fil-kura ta' adulti b'artrite rewmatojde attiva (marda tas-sistema immunitarja li tikkawża l-infjammazzjoni tal-ġogi).
English: Leflunomide Teva treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Maltese: Il-kura b'Leflunomide Teva tibda b'‘doża inizjali' ta' 100 mg darba kuljum għal tliet ijiem, u wara tiġi segwita b'doża ta' manteniment.
English: This means that Leflunomide Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Maltese: Dan ifisser li Leflunomide Teva huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Arava.
English: Other information about Leflunomide Teva
Maltese: Leflunomide Teva leflunomide
English: Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Maltese: Leflunomide jagħmel dan billi jimblokka enzima li tissejjaħ ‘dihydroorotate dehydrogenase', li hija meħtieġa biex il-limfoċiti jimmultiplikaw.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument ta' mistoqsija u tweġiba hawn.
English: Because Leflunomide Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Maltese: Minħabba li Leflunomide Teva huwa mediċina ġenerika, l-istudji fuq pazjenti ġew limitati għal testijiet li jiddeterminaw jekk huwiex bijoekwivalenti għall-mediċina ta' referenza, Arava.
English: The medicine
Maltese: Leflunomide Teva
English: This summary was last updated in 01-2011.
Maltese: Is-sommarju ġie aġġornat l-aħħar f'01-2011.
English: Because Leflunomide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Leflunomide Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu huma meqjusin bħala l-istess għal dawk tal-mediċina ta' referenza.
English: Why has Leflunomide Teva been approved?
Maltese: Għaliex ġie approvat Leflunomide Teva?
English: How has Leflunomide Teva been studied?
Maltese: Kif ġie studjat Leflunomide Teva?
English: How does Leflunomide Teva work?
Maltese: Għalxiex jintuża Leflunomide Teva?
English: It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Maltese: Din tnaqqas linfjammazzjoni billi tnaqqas il-produzzjoni ta' ċelloli immuni li jissejħu ‘limfoċiti', li huma responsabbli għall-infjammazzjoni.
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide Teva, and regularly during treatment.
Maltese: Minħabba li jkun hemm inqas limfoċiti, ikun hemm inqas infjammazzjoni, u dan jgħin biex is-sintomi tal-artrite jiġu kkontrollati.
English: Antiviral activity in vitro
Maltese: Attività anti-virali in vitro
English: Alpha 1-adrenoreceptor antagonists Alfuzosin
Maltese: Antagonisti ta' alpha 1-adrenoreceptor Alfuzosin
English: Immunosupressants Cyclosporin Tacrolimus Sirolimus
Maltese: Immunosoppressanti Cyclosporin Tacrolimus Sirolimus
English: Mutations at protease codons 33, 82, 84 and 90
Maltese: - Mutazzjonijiet f'protease codons 33, 82, 84 u 90
English: Phosphodiesterase 5 (PDE5) inhibitors Sildenafil
Maltese: Impedituri ta' phosphodiesterase 5 (PDE5) Sildenafil
English: Oral contraceptives and oestrogens
Maltese: Kontraċettivi orali u oestrogens
English: Overall population FAS
Maltese: Popolazzjoni globali FAS
English: UNIQUE IDENTIFIER --- 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: Tipranavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M non-clade B isolates (A, C, D, F, G, H, CRF01 AE, CRF02 AG, CRF12 BF).
Maltese: Tipranavir juri attività antivirali in vitro kontra firxa wiesa' ta' HIV-1 group M non-clade B isolates (A, C, D, F, G, H, CRF01 AE, CRF02 AG, CRF12 BF).
English: - abacavir and zidovudine.
Maltese: - abacavir u zidovudine.
English: RESIST study
Maltese: studju RESIST
English: Antiarrhythmics Amiodarone Bepridil
Maltese: Mediċini anti-arritimiċi Amiodarone Bepridil
English: Omeprazole AUC ↓ 70%
Maltese: AUC ta' Omeprazole ↓ 70%
English: Rosuvastatin Cmin ↑ 6%
Maltese: Cmin ta' Rosuvastatin ↑ 6%
English: 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)
Maltese: Komuni ħafna (≥1/10); komuni (≥ 1/100 sa 1/10), mhux komuni (≥1/1,000 sa 1/100), rari (≥1/10,000 sa 1/1,000)
English: Rifabutin Cmin ↑ 114%
Maltese: Cmin ta' Rifabutin ↑ 114%
English: p-value n (%)
Maltese: valur p n (%)
English: Antipsychotics Pimozide
Maltese: Mediċini antipsikotiċi Pimozide
English: Date of latest renewal: 19 June 2015
Maltese: Data tal-aħħar tiġdid: 19 ta' Ġunju, 2015
English: Similar effects were observed for the S-enantiomer, esomeprazole.
Maltese: Effetti simili kienu osservati għall-S-enantiomer, esomeprazole.
English: See also Section 2, under “Oral contraceptives/hormone replacement therapy (HRT)”.
Maltese: Ara wkoll Sezzjoni 2, taħt “Kontraċettivi orali/ terapija ta' sostituzzjoni ormonali (HRT)”.
English: Baseline CD4+ (cells/mm
Maltese: Riferiment bażi CD4+ (celluli/mm
English: Median (Min - Max) % with VL > 100,000 copies/ml
Maltese: Median (Min - Massimu) % b'VL > 100,000 kopji/ml
English: Protease inhibitors (PIs)
Maltese: Impedituri tal-protease (PIs)
English: Metabolic profile of tipranavir
Maltese: Profil metaboliku ta' tipranavir
English: Sedatives/hypnotics Midazolam 2 mg QD (iv)
Maltese: Sedattivi/ipnotiċi Midazolam 2 mg QD (iv)
English: BSA Range (m
Maltese: Firxa BSA (m
English: Butter mint (flavouring) Butter toffee (flavouring) Ascorbic acid
Maltese: Butter toffee (benna) Ascorbic acid
English: Integrase strand transfer inhibitors Raltegravir 400 mg BID Raltegravir Cmax ↔ Raltegravir AUC 0-12↔ Raltegravir C12: ↓ 45%
Maltese: Impedituri tat-trasferiment ta' integrase strand Raltegravir 400 mg BID Cmax ta' Raltegravir ↔ AUC 0-12 ta' Raltegravir ↔ Raltegravir C12: ↓ 45%
English: Abacavir and zidovudine
Maltese: Abacavir u zidovudine
English: UNIQUE IDENTIFIER --- 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Pharmacokinetic enhancer Cobicistat and cobicistatcontaining products
Maltese: Enhancer farmakokinetiku Cobicistat u prodotti li fihom cobicistat
English: Vitamin E polyethylene glycol succinate Purified water
Maltese: Vitamina E polyethylene glycol succinate Ilma purifikat
English: Purified water ‘Sorbitol special-glycerin blend' (d-sorbitol, 1,4 sorbitan, mannitol and glycerin) Titanium dioxide (E171)
Maltese: Ilma purifikat ‘Sorbitol special-glycerin blend' (d-sorbitol, 1,4 sorbitan, mannitol u glycerin) Titanium dioxide (E 171)
English: Baseline HIV-1 RNA (log10 copies/ml)
Maltese: Riferiment bażi ta' RNA għal HIV-1 (log10 kopji/ml)
English: Median (Min - Max)
Maltese: Medjan (Min - Massimu)
English: *Carbamazepine total = total of carbamazepine and epoxycarbamazepine (both are pharmacologically active moieties).
Maltese: *Carbamazepine totali = totali ta' carbamazepine u epoxycarbamazepine ([it-tnejn huma moieties farmakoloġikament attivi).
English: Black printing ink Propylene glycol Black iron oxide (E172) Polyvinyl acetate phthalate Macrogol
Maltese: Linka ta' l-istampar sewda Propylene glycol Black iron oxide (E 172) Polyvinyl acetate phthalate Macrogol
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg QD No clinically significant interaction is observed.
Maltese: Impedituri non-nucleoside tar-reverse transcriptase (NNRTIs) Efavirenz 600 mg QD L-ebda interazzjoni klinikament sinifikanti ma ġiet osservata.
English: Tipranavir is extensively bound to plasma proteins (>99.9%).
Maltese: Tipranavir jeħel b'mod qawwi mal-proteini tal-plażma (>99.9%).
English: Rifabutin 150 mg QD Rifabutin Cmax ↑ 70% Rifabutin AUC ↑ 190%
Maltese: Rifabutin 150 mg QD Cmax ta' Rifabutin ↑ 70% AUC ta' Rifabutin ↑ 190%
English: In a
Maltese: A.
English: INFORMATION IN BRAILLE Aptivus 250 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Aptivus 250 mg
English: Rash:
Maltese: Raxx:
English: Tipranavir is a substrate, an inducer and an inhibitor of cytochrome P450 CYP3A.
Maltese: Tipranavir huwa sustrat, stimulant u impeditur tas-cytochrome P450 CYP3A.
English: Proton pump inhibitors (PPIs) Omeprazole 40 mg QD Omeprazole Cmax ↓ 73%
Maltese: Impedituri tal-pompa tal-proton (PPIs) Omeprazole 40 mg QD Cmax ta' Omeprazole ↓ 73%
English: Rosuvastatin 10 mg QD Rosuvastatin Cmax ↑ 123% Rosuvastatin AUC ↑ 37%
Maltese: Rosuvastatin 10 mg QD Cmax ta' Rosuvastatin ↑ 123% AUC ta' Rosuvastatin ↑ 37%
English: Gastrointestinal motility agents Cisapride
Maltese: Sustanzi tal-moviment gastrointestinali Cisapride
English: Loperamide 16 mg QD Loperamide Cmax ↓ 61% Loperamide AUC ↓ 51%
Maltese: Loperamide 16 mg QD Cmax ta' Loperamide ↓ 61% AUC ta' Loperamide ↓ 51%
English: 3, respectively, (ranges 1-1893 and 1
Maltese: 3, rispettivament, (fuq firxa ta' bejn 1-1893 u 1-1184 ċelluli/mm
English: Carbamazepine induces CYP3A4.
Maltese: Carbamazepine jikkaġuna CYP3A4.
English: INFORMATION IN BRAILLE Aptivus 100 mg/ml
Maltese: INFORMAZZJONI BIL-BRAILLE Aptivus 100 mg/ml
English: Previous ADI*
Maltese: ADI Preċedenti*
English: C-tipranavir human study (500 mg
Maltese: C-tipranavir (500 mg
English: Colchicine is a substrate of CYP3A4 and P-gp (an intestinal efflux transporter).
Maltese: Colchicine hu sottostrat ta' CYP3A4 u P-gp (trasportatur talefflus intestinali).
English: Buprenorphine/Naloxone Buprenorphine ↔ Norbuprenorphine AUC  79% Norbuprenorphine Cmax  80% Norbuprenorphine Cmin  80%
Maltese: Norbuprenorphine  79% Cmax ta' Norbuprenorphine  80% Cmin ta' Norbuprenorphine  80%
English: Atazanavir Cmax ↓ 57% Atazanavir AUC ↓ 68% Atazanavir Cmin ↓ 81%
Maltese: Cmax ta' Atazanavir ↓ 57% AUC ta' Atazanavir ↓ 68% Cmin ta' Atazanavir ↓ 81%
English: Macrogolglycerol ricinoleate Ethanol
Maltese: Il-kontenut tal-kapsula Macrogolglycerol ricinoleate Ethanol
English: Includes abdominal pain (N=1), dysphagia (N=1) and epigastric discomfort (N=1).
Maltese: Jinkludi uġigħ addominali (N=1) u disfaġja (N=1) u skonfort epigastriku (N=1).
English: Ergot derivatives Dihydroergotamine Ergonovine Ergotamine Methylergonovine No interaction study performed
Maltese: Derivattivi ta' ergot Dihydroergotamine Ergonovine Ergotamine Methylergonovine Ma sarux studji dwar linterazzjonijiet
English: At 48-weeks the relative risk decreased to 1.27 (95% CI=0.76, 2.12).
Maltese: Mat-48 ġimgħa rriskju relattiv tnaqqas għal 1.27 (95% CI=0.76, 2.12).
English: Tipranavir Cmax ↔ Tipranavir AUC ↔ Tipranavir Cmin ↓ 26%
Maltese: Cmax ta' Tipranavir ↔ AUC ta' Tipranavir ↔ Cmin ta' Tipranavir ↓ 26%
English: Oral contraceptives / Oestrogens Ethinyl oestradiol 0.035 mg / Norethindrone 1.0 mg QD (TPV/r 750/200 mg BID)
Maltese: Kontraċettivi orali/Estroġeni Ethinyl oestradiol 0.035 mg / Norethindrone 1.0 mg QD (TPV/r 750/200 mg BID)
English: Nucleoside analogue DNA polymerase inhibitors Valaciclovir 500 mg single dose
Maltese: Impedituri nucleoside analogue DNA polymerase Valaciclovir doża waħda ta' 500 mg
English: Dose Aptivus (mg)
Maltese: Doża ta' Aptivus (mg)
English: Aptivus/ritonavir dose (375 mg/m2 Aptivus + 150 mg/m2 ritonavir)
Maltese: Doża ta' Aptivus ma' ritonavir (375 mg/m2 Aptivus + 150 mg/m2 ritonavir)
English: Anticonvulsants Carbamazepine 200 mg BID
Maltese: Mediċini kontra l-konvulżjoni Carbamazepine 200 mg BID
English: Fluconazole 200 mg QD (Day 1) then 100 mg QD
Maltese: Fluconazole 200 mg QD (Jum 1) imbagħad 100 mg QD
English: Mint and Butter Toffee flavourings.
Maltese: benna tal-Butter Mint u Butter Toffee..
English: - with ENF (FAS) - without ENF (FAS)
Maltese: - b'ENF (FAS) - mingħajr ENF (FAS)
English: Aptivus 100 mg/ml oral solution tipranavir
Maltese: Aptivus 100 mg/ml soluzzjoni orali tipranavir
English: Studies in human liver microsomes indicated tipranavir is an inhibitor of CYP 1A2, CYP 2C9, CYP 2C19 and CYP 2D6.
Maltese: Studji fil-mikrożomi tal-fwied uman indikaw li tipranavir huwa impeditur għal CYP 1A2, CYP 2C9, CYP 2C19 u CYP 2D6.
English: The capsule shell contains gelatin, red iron oxide, propylene glycol, purified water, ‘sorbitol special-glycerin blend' (d-sorbitol, 1,4 sorbitan, mannitol and glycerin) and titanium dioxide.
Maltese: Il-qoxra tal-kapsula fiha ġelatina, red iron oxide, propylene glycol, ilma purifikat, ‘sorbitol specialglycerin blend' (d-sorbitol, 1,4 sorbitan, mannitol u glycerin) u titanium dioxide.
English: Abacavir Cmax ↓ 46% Abacavir AUC ↓ 36%
Maltese: Cmax ta' Abacavir ↓ 46% AUC ta' Abacavir ↓ 36%
English: The black printing ink contains propylene glycol, black iron oxide, polyvinyl acetate phthalate, macrogol and ammonium hydroxide.
Maltese: Il-linka ta' l-istampar sewda tikkonsisti minn propylene glycol, black iron oxide, polyvinyl acetate phthalate, macrogol u ammonium hydroxide.
English: Narcotic analgesics Methadone 5 mg QD Methadone Cmax ↓ 55% Methadone AUC ↓ 53% Methadone Cmin ↓ 50%
Maltese: Analġesiċi narkotiċi Methadone 5 mg QD Cmax ta' Methadone ↓ 55% AUC ta' Methadone ↓ 53% Cmin ta' Methadone ↓ 50%
English: Bupropion 150 mg BID Bupropion Cmax ↓ 51% Bupropion AUC ↓ 56%
Maltese: Bupropion 150 mg BID Cmax ta' Bupropion ↓ 51% AUC ta' Bupropion ↓ 56%
English: Do not store below 15°C.
Maltese: Taħżinx f'temperatura taħt 15°C.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany.
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Boehringer Ingelheim Pharma GmbH & Co.KG, Binger Strasse 173, D-55216 Ingelheim am Rhein, Il-Ġermanja.
English: Didanosine Cmax ↓ 43% Didanosine AUC ↓ 33%
Maltese: Cmax ta' Didanosine ↓ 43% AUC ta' Didanosine ↓ 33%
English: With respect to mutations on codons 33, 82, 84 and 90 approximately 4% had no mutations, 24% had mutations at codons 82 (less than 1% of patients had the mutation V82L) and 90, 18% had mutations at codons 84 and 90 and 53% had at least one key mutation at codon 90.
Maltese: Fir-rigward ta' mutazzjonijiet fil-codons 33, 82, 84 u 90 madwar 4% ma kellhomx mutazzjonijiet, 24% kellhom mutazzjonijiet f'codons 82 (inqas minn 1% tal-pazjenti kellhom mutazzjoni f'V82L) u 90, 18% kellhom mutazzjonijiet f'codons 84 u 90 u 53% kellhom ta' lanqas mutazzjoni ewlenija f'codon 90.
English: 3); median baseline plasma HIV-1 RNA was 4.79 and 4.80 log10 copies/ml, respectively (ranges 2.34-6.52 and 2.01-6.76 log10 copies/ml).
Maltese: 3); il-valur tal-linja bażi medja ta' HIV-1 RNA kienet ta' 4.79 u 4.80 log10kopji/ml, rispettivament (fuq firxa ta' 2.34-6.52 u 2.01-6.76 log10 kopji/ml).
English: Phenobarbital and phenytoin induce CYP3A4.
Maltese: Phenobarbital u phenytoin jikkaġunaw CYP3A4.
English: Ethinyl oestradiol Cmax ↓ 52% Ethinyl oestradiol AUC ↓ 43% Mechanism unknown Norethindrone Cmax ↔ Norethindrone AUC ↑ 27% Tipranavir ↔
Maltese: Cmax ta' Ethinyl oestradiol ↓ 52% AUC ta' Ethinyl oestradiol ↓ 43% Mekkaniżmu mhux magħruf Cmax ta' Norethindrone ↔ AUC ta' Norethindrone ↑ 27% Tipranavir ↔
English: Etravirine Cmax ↓ 71% Etravirine AUC ↓ 76% Etravirine Cmin ↓ 82%
Maltese: Cmax ta' etravirine ↓ 71% AUC ta' etravirine ↓ 76% Cmin ta' etravirine ↓ 82%
English: PHARMACEUTICAL FORM Oral solution.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni orali.
English: This is due to induction of drug metabolising enzymes by St John's wort.
Maltese: Dan hu minħabba l-induzzjoni ta' enzimi metabolanti fil-mediċina minn St John's wort.
English: Aptivus capsules contain ethanol, macrogolglycerol ricinoleate and sorbitol (E420) Aptivus contains 7 % ethanol (alcohol), i.e. up to 400 mg per daily dose, equivalent to 8 ml of beer, or less than 4 ml of wine.
Maltese: Il-kapsuli Aptivus fihom l-ethanol, macrogolglycerol ricinoleate u sorbitol (E420) Aptivus fih 7 % ethanol (alkoħol), ie sa doża ta' 400 mg kuljum, ekwivalenti għal 84 ml ta' birra jew inqas minn 4 ml ta' inbid.
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (f'temperatura ta' 2°C - 8°C).
English: Clinical pharmacodynamic data
Maltese: Dejta farmakodinamika klinikali
English: HMG CoA reductase inhibitors Atorvastatin 10 mg QD Atorvastatin Cmax ↑ 8.6 fold Atorvastatin AUC ↑ 9.4 fold Atorvastatin Cmin ↑ 5.2 fold
Maltese: Impedituri ta' HMG-CoA reductase Atorvastatin 10 mg QD Cmax ta' Atorvastatin ↑ 8.6 darbiet AUC ta' Atorvastatin ↑ 9.4 darbiet Cmin ta' Atorvastatin ↑ 5.2 darbiet
English: PHARMACEUTICAL FORM AND CONTENTS 120 soft capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 120 kapsula ratba
English: Dose ritonavir (mg)
Maltese: Doża ta' ritonavir (mg)
English: Amprenavir Cmax ↓ 39% Amprenavir AUC ↓ 44% Amprenavir Cmin ↓ 55%
Maltese: Cmax ta' Amprenavir ↓ 39% AUC ta' Amprenavir ↓ 44% Cmin ta' Amprenavir ↓ 55%
English: Tipranavir Cmax  8% Tipranavir AUC  20% Tipranavir Cmin  75%
Maltese: Cmax ta' Tipranavir  8% AUC ta' Tipranavir  20% Cmin ta' Tipranavir  75%
English: First-dose tipranavir/r Digoxin Cmax ↑ 93% Digoxin AUC ↑ 91%
Maltese: L-ewwel doża ta' tipranavir/r Cmax ta' Digoxin ↑ 93% AUC ta' Digoxin ↑ 91%
English: Interactions with other HIV medicines: - etravirine belongs to a class of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Maltese: Interazzjonijiet ma' mediċini oħra tal-HIV: - etravirine jappartjeni għal klassi ta' mediċini kontra l-HIV imsejħa non-nucleoside reverse transcriptase inhibitors (NNRTIs).
English: Aptivus is not a cure for HIV infection:
Maltese: Aptivus mhuwiex kura għal infezzjoni b'HIV:
English: R-methadone Cmax ↓ 46% R-methadone AUC ↓ 48%
Maltese: Cmax ta' R-methadone ↓ 46% AUC ta' R-methadone ↓ 48%
English: Saquinavir Cmax ↓ 70% Saquinavir AUC ↓ 76% Saquinavir Cmin ↓ 82%
Maltese: Cmax ta' Saquinavir ↓ 70% AUC ta' Saquinavir ↓ 76% Cmin ta' Saquinavir ↓ 82%
English: This medicine contains sorbitol.
Maltese: Din il-mediċina fiha sorbitol.
English: Tipranavir Cmax ↑ 40% Tipranavir AUC ↑ 66% Tipranavir Cmin ↑ 100%
Maltese: Cmax ta' Tipranavir ↑ 40% AUC ta' Tipranavir ↑ 66% Cmin ta' Tipranavir ↑ 100%
English: Includes abdominal pain (N=1) and dyspepsia (N=1).
Maltese: Jinkludi uġigħ addominali (N=1) u dispepsja (N=1).
English: Ritonavir acts by inhibiting hepatic cytochrome P450 CYP3A, the intestinal P-glycoprotein (P-gp) efflux pump and possibly intestinal cytochrome P450 CYP3A as well.
Maltese: Ritonavir jaġixxi billi jimpedixxi ċ-ċitokroma epatika P450 CYP3A, P-glycoprotein (P-gp) efflux pump ta' l-imsaren u possibbilment ċ-ċitokroma ta' l-imsaren P450 CYP3A ukoll.
English: No cases of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis have been reported in the clinical development programme of tipranavir.
Maltese: Ma kien ebda każijiet irraportati tas-Sindromu ta' Stevens-Johnson jew in-Nekrolisi Epidermali Tossika fil-programm ta' żvilupp kliniku ta' tipranavir.
English: Contains macrogolglycerol ricinoleate, sorbitol and ethanol (see package leaflet for further information)
Maltese: TA' EĊĊIPJENTI Fih macrogolglycerol ricinoleate, sorbitol u ethanol (ara l-fuljett tal-pakkett għal aktar informazzjoni)
English: Didanosine Cmax ↓ 24% Didanosine AUC ↔
Maltese: Cmax ta' Didanosine ↓ 24% AUC ta' Didanosine ↔
English: Zidovudine Cmax ↓ 49% Zidovudine AUC ↓ 36%
Maltese: Cmax ta' Zidovudine ↓ 49% AUC ta' Zidovudine ↓ 36%
English: 25-O-desacetylrifabutin Cmin ↑ 7.8 fold
Maltese: Cmin ta' 25-O-desacetylrifabutin ↑ 7.8 darbiet
English: - digoxin (used to treat heart arrhythmias and heart failure) - antifungal medications including fluconazole, itraconazole, ketoconazole or voriconazole
Maltese: - mediċini antifungali li jinkludu fluconazole, itraconazole, ketoconazole jew voriconazole
English: Tipranavir maintains significant antiviral activity (< 4-fold resistance) against the majority of HIV-1 clinical isolates showing post-treatment decreased susceptibility to the currently approved protease inhibitors: amprenavir, atazanavir, indinavir, lopinavir, ritonavir, nelfinavir and saquinavir.
Maltese: Tipranavir iżomm attività ta' kontra l-vajrus sinifikanti (reżistenza < 4 darbiet aktar) kontra lmaġġoranza tal-kampjuni kliniċi ta' HIV-1 li juru tnaqqis fis-suxxettibblità ta' wara t-trattament għal impedituri protease li huma approvati attwalment: amprenavir, atazanavir, indinavir, lopinavir, ritonavir, nelfinavir u saquinavir.
English: There was an average decrease in susceptibility of 2-fold wild type (WT) for tipranavir, 12-fold WT for amprenavir, 55-fold WT for atazanavir, 41-fold WT for indinavir, 87-fold WT for lopinavir, 41fold WT for nelfinavir, 195-fold WT for ritonavir, and 20-fold WT for saquinavir.
Maltese: Kien hemm tnaqqis medju fis-suxxettibilità ta' darbtejn għat-tip selvaġġ (WT) għal tipranavir, 12-il darba għal amprenavir, 55 darba WT għal atazanavir, 41 darba WT għal indinavir, 87 darba WT għal lopinavir, 41 darba WT għal nelfinavir, 195 darba WT għal ritonavir u 20 darba WT għal saquinavir.