FrancophonIA/ELRC3.0 huggingface dataset:
English: Moreover, it appears that the prolonged release part of the formulation is not significantly affected by food, which is confirmed by the similar results obtained in the studies with the 54 mg strength in fasting and fed conditions, respectively, for both the test and reference product.
Maltese: Barra minn hekk, jidher li l-parti tal-formulazzjoni li terħi l-mediċina bil-mod mhijiex affettwata b'mod sinifikanti mill-ikel, li huwa kkonfermat mir-riżultati simili miksuba fl-istudji bil-qawwa ta' 54 mg f'kundizzjonijiet ta' stonku vojt u wara l-ikel, rispettivament, kemm għall-prodott tat-test kif ukoll għall-prodott ta' referenza.
English: The applicant/MAH claimed that the administration of a biphasic methylphenidate modified release formulation with a high fat meal has a major impact on the gastric emptying and transit time, and therefore, can lead to different shapes in the pharmacokinetic profiles in the early absorption phase.
Maltese: L-applikant/detentur tal-awtorizzazzjoni għat-tqegħid fis-suq sostna li l-għoti ta' formulazzjoni ta' methylphenidate b'żewġ fażijiet li terħi l-mediċina b'mod modifikat flimkien ma' ikla b'kontenut għoli ta' xaħam kellu impatt kbir fuq it-tbattil tal-istonku u fuq il-ħin tal-passaġġ, u għalhekk, jista' jwassal għal mudelli differenti fil-profili farmakokinetiċi fil-fażi tal-assorbiment bikri.
English: Ethinylestradiol and terbutaline
Maltese: Ethinylestradiol u terbutaline
English: de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Maltese: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spanja.
English: Angioedema2
Maltese: Anġjoedima2
English: Date of last renewal: 12 November 2012
Maltese: Data tal-aħħar tiġdid: 12 ta' Novembru 2012
English: CYP2C9 substrates (e.g. R-warfarin)
Maltese: Substrati CYP2C9 (e.ż. R-warfarin)
English: Tachycardia, Palpitations
Maltese: Takikardija, Palpitazzjonijiet
English: Adult men
Maltese: Irġiel adulti
English: Nitrates
Maltese: Nitrati
English: - phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
Maltese: - phenobarbital, phenytoin u carbamazepine (mediċini kontra l-aċċessjonijiet).
English: Hypotension3, Hypertension
Maltese: Ipotensjoni3 , Ipertensjoni
English: CYP1A2 substrates (e.g. theophylline)
Maltese: Substrati CYPIA2 (e.g. theophylline)
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: These effects are unlikely to lead to a lack of fertility.
Maltese: Dan mhux probabbli li jwassal għal nuqqas ta' fertilità.
English: Nederland Eli Lilly Nederland B.V.
Maltese: Eli Lilly Nederland B.V.
English: - sudden loss of vision (frequency rare).
Maltese: - telf tal-vista f'daqqa waħda (frekwenza rari).
English: See leaflet for further information.
Maltese: Tkellem mat-tabib tiegħek għal aktar informazzjoni.
English: Papendorpseweg 83, 3528 BJ Utrecht The Netherlands
Maltese: Papendorpseweg 83, 3528 BJ Utrecht L-Olanda
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 November 2002
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni:12 ta' Novembru 2002
English: Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19.
Maltese: Xi studji kkonfermaw li tadalafil ma jinibixxix jew ma jistimulax iżoformi ta' CYP450, iklużi CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 u
English: The major circulating metabolite is the methylcatechol glucuronide.
Maltese: Ilmetabolu prinċipali ċirkolanti huwa methylcatechol glucuronide.
English: BATCH NUMBER Lot.
Maltese: NUMRU TAL- LOTT Lott.
English: Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Maltese: Tadalafil huwa inibitur riversibbli, selettiv ta' cyclic guanosine monophosphate (cGMP) speifikament phosphodiesterase tip 5 (PDE5).
English: - are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite.
Maltese: - qed tieħu xi forma ta' nitrate organiku jew donaturi ta' nitric oxide bħal amyl nitrite.
English: Frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to
Maltese: Konvenzjoni tal-frekwenza: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1000), Rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli)
English: CIALIS may still be effective up to 36 hours after taking the tablet.
Maltese: CIALIS jista' jibqa' effettiv sa 36 siegħa wara li tieħu l-pillola.
English: - a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
Maltese: - inibitur ta' 5-alpha reductase (użat fil-kura ta' iperplażja beninna tal-prostata).
English: See also section 5.1.
Maltese: Ara wkoll sezzjoni 5.1
English: Tadalafil did not show efficacy in slowing the decline in ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean change in 6MWD at 48 weeks was -51.0 meters (m) in the placebo group, compared with -64.7 m in the tadalafil 0.3 mg/kg group (p = 0.307) and -59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538).
Maltese: Tadalafil ma weriex effikaċja biex inaqqas ittnaqqis fl-ippassiġġar kif imkejjel permezz tal-punt finali primarju tad-distanza li wieħed jimxi f'6 minuti (6MWD - 6 minute walk distance): il-bidla medja fl-inqas numru ta' kwadrati (LS -least squares ) f'6MWD fit-48 ġimgħa kien -51.0 metri (m) fil-grupp tal-plaċebo, meta mqabbel ma' -64.7 m fil-grupp ta' tadalafil 0.3 mg/kg (p = 0.307) u -59.1 m fil-grupp ta' tadalafil 0.6 mg/kg
English: Also, patients with erectile dysfunction in all severity categories reported improved erections whilst taking CIALIS (86 %, 83 %, and 72 % for mild, moderate, and severe, respectively, as compared to 45 %, 42 %, and 19 % with placebo).
Maltese: pazjenti b'disfunzjoni erettili fil-kategoriji kollha ta' severita' kellhom erezzjonijiet imtejbin meta ħadu CIALIS (86%, 83%, u 72% għal disfunzjoni ħafifa, moderata, u gravi, rispettivament, meta mqabbel ma' 45%, 42%, u 19% li ħadu l-plaċebo).
English: This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway.
Maltese: Dan huwa maħsub li jirriżulta mill-effetti kkombinati ta' nitrati u tadalafil fir-rotta ta' nitric oxide/cGMP.
English: 5- alpha reductase inhibitors
Maltese: Inibituri ta' 5-alpha reductase
English: Hypersensitivity reactions
Maltese: sensittività eċċessiva
English: - a severe kidney problem.
Maltese: - problema serja tal-kliewi.
English: This metabolite is at least 13,000-fold less potent than tadalafil for PDE5.
Maltese: Dan il-metabolu huwa mill-inqas 13,000-il darba inqas qawwi minn tadalafil għal PDE5.
English: This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”).
Maltese: Dan huwa grupp ta' mediċini (“nitrati”) li jintużaw fit-trattament ta' angina pectoris (“uġigħ fis-sider”).
English: In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates.
Maltese: Fl-istudji kliniċi, tadalafil (5, 10 u 20 mg) deher li jkabbar l-effetti ipotensivi tan-nitrati.
English: OTHER MON, TUE, WED, THU, FRI, SAT, SUN
Maltese: OĦRAJN TNE, TLI, ERB, ĦAM, ĠIM, SIB, ĦAD
English: Over a dose range of 2.5 to 20 mg, exposure (AUC) increases proportionally with dose.
Maltese: Fi skala ta' doża minn 2.5 sa 20 mg, l-esponiment (AUC) jiżdied b'mod proporzjonali għad-doża.
English: Cytochrome P450 inducers
Maltese: Indutturi Cytochrome P450
English: The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues.
Maltese: Il-volum medju tad-distribuzzjoni huwa madwar 63 l, li jindika li tadalafil jiġi distribwit fit-tessuti.
English: Myocardial infarction, Unstable angina pectoris2, Ventricular arrhythmia2
Maltese: Infart mijokardijaku, Angina pectoris instabbli2, Arritmja ventrikulari2
English: Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax by 22 %.
Maltese: Ketoconazole (400 mg kuljum) żied l-esponiment għal tadalafil (20 mg) (AUC) b'erba darbiet u Cmax bi 22%.
English: Tadalafil is principally metabolised by CYP3A4.
Maltese: Tadalafil huwa prinċipalment metaboliżżat minn CYP3A4.
English: Priapism, Penile haemorrhage, Haematospermia
Maltese: Prijapiżmu, Emorraġija fil-pene, Ematospermja
English: CIALIS 20 mg is available in blister packs containing 2, 4, 8, 10 or 12 tablets.
Maltese: CIALIS 20 mg issibu f'pakketti b'folji ta' 2, 4, 8, 10 jew 12-il pillola.
English: Erectile dysfunction in adult men
Maltese: Disfunzjoni erettili fl-irġiel adulti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/237/007-008, 010
Maltese: FIS-SUQ EU/1/02/237/007-008, 010
English: In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin.
Maltese: F'studji ta' interazzjoni magħmula fuq numru limitat ta' volontiera b'saħħithom, dawn l-effetti ma ġewx irrapportati b'alfuzosin u tamsulozin.
English: CIALIS 2.5 mg is available in blister packs containing 28 tablets.
Maltese: CIALIS 2.5 mg issibu f'pakketti b'folji li fihom 28 pillola.
English: Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq : Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda.
English: Priapism and anatomical deformation of the penis
Maltese: Prijapiżmu u deformazzjoni anatomika tal-pene
English: - rifampicin, erythromycin , clarithromycin or itraconazole.
Maltese: - rifampicin, erythromycin , clarithromycin jew itraconazole. - trattamenti oħra għad-disfunzjoni erettili.
English: - medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
Maltese: - mediċini bħall-pilloli ketoconazole (biex tikkura infezzjonijiet tal-moffa) u inibituri ta' protease għall-kura tal-AIDS u tal-HIV.
English: Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see section 4.3).
Maltese: It-teħid fl-istess ħin ta' riociguat ma' inibituri ta' PDE5, inkluż tadalafil, huwa kontraindikat (ara sezzjoni 4.3).
English: Consequently, it is not expected to be clinically active at observed metabolite concentrations.
Maltese: Konsegwentement, mhuwiex mistenni li jkun klinikament attiv fil-konċentrazzjonijiet osservati tal-metabolu.
English: PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum.
Maltese: PDE5 hija enżima li tinsab fil-muskoli involontarji tal-corpus cavernosum, fil-muskoli involuntarji vaskolari u vixxerali, fil-muskoli skeletali, plejtlits, fil-kliewi, fil-pulmuni u fiċ-ċervellett.
English: Urticaria, Stevens-Johnson syndrome2, Exfoliative dermatitis2, Hyperhydrosis (sweating)
Maltese: Urtikarja, Sindromu ta' Stevens-Johnson2, Dermatite esfoljattiva2,
English: What CIALIS contains - The active substance is tadalafil.
Maltese: - Is-sustanza attiva hi tadalafil.
English: Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 ml of 40 % alcohol [vodka] in an 80-kg male) but in some subjects, postural dizziness and orthostatic hypotension were observed.
Maltese: Tadalafil (20 mg) ma żiedx il-medja tat-tnaqqis ta' pressjoni tad-demm prodotta mill-alkoħol (0.7 g/kg jew madwar 180 ml ta' 40% alkoħol [vodka] f'irġiel ta' 80 kg) iżda f'xiindividwi, kienu osservati sturdament dovut għat-tibdil fil-pożizzjoni tal-persuna u pressjoni baxxa ortostatika.
English: The improvement in the total international prostate symptom score with CIALIS 5mg in the four studies were -4.8, -5.6, -6.1 and -6.3 compared to -2.2,3.6, -3.8 and -4.2 with placebo.
Maltese: It-titjib fil-total tal-punteġġ internazzjonali għas-sintomi tal-prostata b'CIALIS 5 mg fl-erba' studji kienu -4.8, -5.6 u -6.3 meta mqabbel ma' -2.2, -3.6, -3.8 u -4.2 bi plaċebo.
English: These effects are normally mild to moderate in nature.
Maltese: Dawn l-effetti normalment ikunu ta' natura ħafifa jew moderata.
English: Major classes of antihypertensive medicinal products were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers).
Maltese: Klassijiet ewlenin ta' prodotti mediċinali li jintużaw kontra l-pressjoni għolja kienu studjati, inklużi l-calcium channel blockers (amlodipine), inibituri ta' lenżimi li jbiddlu l-angiotensin (ACE) (enalapril), dawk li jimblukkaw ir-riċetturi beta-adrenerġiċi (metoprolol), id-djuretiċi ta't-tip thiazide (bendrofluazide), u dawk li jimblukkaw ir-riċetturi ta' l angiotensin II (tipi u dożi varji, waħedhom jew flimkien ma' thiazides, dawk li jimblukkaw il-passaġġi tal-kalċjum, blokkaturi-beta, u/jew blokkaturi-alpha).
English: Before treatment with CIALIS
Maltese: Mediċini oħra u CIALIS
English: Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
Maltese: Qalba tal-pillola: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
English: Benign prostatic hyperplasia
Maltese: Iperplażja beninna tal-prostata
English: Use with CYP3A4 inhibitors
Maltese: L-użu ma inibituri CYP3A4
English: CIALIS 10 mg is available in blister packs containing 4 tablets.
Maltese: CIALIS 10 mg issibu f'pakketti b'folji ta' 4 pilloli.
English: The mean per-subject proportion of successful sexual intercourse attempts was 71.9% with CIALIS 5 mg compared to 48.3% with placebo.
Maltese: Il-proporzjon ta' tentattivi ta' kopulazzjoni sesswali b'suċċess għal kull pazjent kien medja ta' 71.9% għall-pazjenti b'CIALIS 5 mg meta mqabbel ma' 48.3% għall-pazjenti fuq plaċebo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/237/002-005, 009
Maltese: FIS-SUQ EU/1/02/237/002-005, 009
English: 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 10 film-coated tablets 12 film-coated tablets
Maltese: 2 pilloli miksijin b'rita 4 pilloli miksijin b'rita 8 pilloli miksijin b'rita 10 pilloli miksijin b'rita 12-il pillola miksijin b'rita
English: Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.
Maltese: Il-kura tas-sinjali u s-sintomi tal-iperplażja beninna tal-prostata fl-irġiel adulti.
English: Light orange-yellow and almond shaped tablets, marked "C 2 ½" on one side.
Maltese: Pilloli oranġjo-sofor ċari u għandhom forma ta' lewża, immarkati "C 2½" fuq naħa waħda.
English: Each coated tablet contains 87 mg of lactose (as monohydrate).
Maltese: Kull pillola miksija fiha 87 mg lactose (bħala monohydrate).
English: CIALIS 5 mg is available in blister packs containing 14, 28 or 84 tablets.
Maltese: CIALIS 5 mg issibu f'pakketti b'folji li fihom 14, 28 jew 84 pillola.
English: Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform.
Maltese: Tadalafil huwa prinċipalment metabolizzat permezz ta' l-iżoforma ċitokromju P450 (CYP) 3A4 .
English: Alcohol concentrations (mean maximum blood concentration 0.08 %) were not affected by coadministration with tadalafil (10 mg or 20 mg).
Maltese: Alkoħol Konċentrazzjonijiet ta' l-alkoħol (medja massima tal-konċentrazzjoni fid-demm 0.08%) ma kinux affettwati mit-teħid ta' tadalafil magħhom (10 mg jew 20 mg).
English: In one of the studies, which also included tamsulosin 0.4 mg as an active comparator, the improvement in total international prostate symptom score with CIALIS 5mg, tamsulosin and placebo were -6.3, -5.7 and -4.2 respectively.
Maltese: 0.4 mg bħala komparatur attiv, it-titjib fit-total tal-punteġġ internazzjonali għas-sintomi tal-prostata b'CIALIS 5 mg, tamsulosin u plaċebo kienu ta' -6.3, -5.7 u -4.2 rispettivament.
English: In a clinical trial that compared tadalafil 5 mg coadministered with finasteride 5 mg to placebo plus finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified.
Maltese: Ma ġiet identifikata ebda reazzjoni avversa ġdida f'studju kliniku fejn tadalafil 5 mg mogħti flimkien ma' finasteride 5 mg ġie mqabbel ma' plaċebo flimkien ma' finasteride 5 mg għas-solliev mis-sintomi ta' BPH.
English: Benign prostatic hyperplasia in adult men
Maltese: Iperplażja beninna tal-prostata fl-irġiel adulti
English: Patients who are unable to tolerate tadalafil 5 mg for the treatment of benign prostatic hyperplasia should consider an alternative therapy as the efficacy of tadalafil 2.5mg for the treatment of benign prostatic hyperplasia has not been demonstrated.
Maltese: Pazjenti li ma jkunux kapaċi jittolleraw id-doża ta' tadalafil 5 mg għall-kura tal-iperplażja beninna tal prostata għandhom jikkunsidraw terapija alternattiva peress li l-effikaċja ta' tadalafil 2.5 mg ma ġietx murija fl-iperplażja beninna tal-prostata.
English: Facial oedema2,
Maltese: Uġigħ tad-dahar,
English: At therapeutic concentrations, 94 % of tadalafil in plasma is bound to proteins.
Maltese: F'konċentrazzjonijiet terapewtiċi, 94% ta' tadalafil fil-plażma jkun marbut mal-proteini.
English: This will be given as a 2.5mg tablet.
Maltese: Din tingħata bħala pillola ta' 2.5 mg.
English: CIALIS is a treatment for adult men with erectile dysfunction.
Maltese: CIALIS huwa trattament għall-irġiel adulti b'disfunzjoni erettili.
English: Consequently the incidence of the adverse reactions listed in section 4.8 might be increased.
Maltese: Konsegwentement l-inċidenza tal-effetti avversi elenkati fit-sezzjoni 4.8 tista' tiżdied.
English: In the study in patients with erectile dysfunction secondary to diabetes, the mean per-subject proportion of successful attempts were 41 and 46 % on CIALIS 5 mg and 2.5 mg, respectively, as compared to 28 % with placebo.
Maltese: Fl-istudju f'pazjenti li kellhom disfunzjoni erettili sekondarja għad-dijabete, il-proporzjon ta' tentattivi ta' suċċess għal kull pazjent kienu medja ta' 41 u 46% għal dawk fuq CIALIS 5 mg u 2.5 mg rispettivament, meta mqabbel ma' 28% li ħadu plaċebo.
English: In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates.
Maltese: Fi studji kliniċi, tadalafil intwera li jkabbar l-effetti ipotensivi tan-nitrati.
English: - removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non nerve-sparing prostatectomy).
Maltese: - tneħħija totali jew ta' parti tal-glandola tal-prostata fejn jiġu mqatta' n-nervituri tal-prostata (prostatektomija radikali li taffettwa n-nervituri).
English: In clinical pharmacology studies using single-dose tadalafil (5 to 20 mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/min) or moderate (creatinine clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis.
Maltese: Fl-istudji tal-farmakoloġija klinika fejn intużat doża waħda ta' tadalafil (5 sa 20 mg), l-esponiment għal tadalafil (AUC) kien madwar id-doppju f'individwi b'indeboliment ħafif fil-kliewi (tneħħija tal krejatinina 51 sa 80 ml/min) jew moderat (tneħħija tal-krejatinina 31 sa 50 ml/min) u f'individwi fuq id-dijaliżi bi stat terminali tal-funzjoni tal-kliewi.
English: Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
Maltese: Kisja b'rita: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
English: CIALIS 20 mg film-coated tablets Aluminium/PVC blisters in cartons of 2, 4, 8, 10 and 12 film-coated tablets.
Maltese: Folji tal-aluminju /PVC f'kartuniet ta' 2, 4, 8, 10 u 12-il pillola miksijin b'rita.
English: INFORMATION IN BRAILLE cialis 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE cialis 20 mg
English: Tadalafil is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4, enzymes which are found in the heart, brain, blood vessels, liver, and other organs.
Maltese: Tadalafil huwa > 10,000 darba aktar potenti għal PDE5 milli għal PDE1, PDE2 u PDE4, li huma enżimi li jinsabu fil-qalb, fil-moħħ, fil-vini u l-arterji, fil-fwied u f'organi oħra.
English: Renal insufficiency
Maltese: Insuffiċjenza renali
English: Treatment of erectile dysfunction in adult males.
Maltese: Trattament ta' disfunzjoni erettili fl-irġiel adulti.
English: INFORMATION IN BRAILLE cialis 2.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE cialis 2.5 mg
English: Each coated tablet contains 121 mg lactose (as monohydrate).
Maltese: Kull pillola miksija fiha 121 mg lactose (bħala monohydrate).
English: A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15 %, relative to the AUC and Cmax values for tadalafil alone.
Maltese: Inibitur selettiv ta' CYP3A4, ketoconazole (200 mg kuljum), żied l-esponiment għal tadalafil (10-mg) (AUC) b'darbtejn u Cmax bi 15%, relattivament għall-AUC u għal valuri ta' Cmax għal tadalafil biss.
English: Caution should be exercised when prescribing CIALIS to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined (see section 4.5).
Maltese: Wieħed għandu joqgħod attent meta jikteb riċetta għal CIALIS lill-pazjenti li qed jużaw inibituri qawwijin ta' CYP3A4 (ritonavir, saquinavir, ketoconazole, itraconazole, u erythromycin) għaliex kien osservat esponiment akbar għal tadalafil (AUC) meta l-prodotti mediċinali jingħataw flimkien (Ara sezzjoni 4.5).
English: ELI LILLY ČR, s.r.o.
Maltese: ČR, s.r.o.
English: Yellow and almond shaped tablets, marked "C 20" on one side.
Maltese: Pilloli sofor u għandhom forma ta' lewża, immarkati "C 20" fuq naħa waħda.
English: It may be taken at least 30 minutes prior to sexual activity.
Maltese: Tista' tittieħed għall-inqas 30 minuta qabel l-attivita' sesswali.
English: Stroke1 (including haemorrhagic events), Syncope, Transient ischaemic attacks1, Migraine2, Seizures2, Transient amnesia
Maltese: (inklużi avvenimenti emorraġiċi), Sinkope, Attakki iskemiċi tranżitorji1, Emikranja2 Konvulżjonijiet2, Amnesija tranżitorja
English: Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin.
Maltese: Tadalafil (10 mg 20 mg) ma kellu l-ebda effett klinikament sinifikanti fuq l-espożizzjoni (AUC) għal S-warfarin jew R-warfarin (substrat ta' CYP2C9), u tadalafil lanqas ma affettwa tibdil fil-ħin talprotrombin indott mill-warfarin.
English: Each coated tablet contains 233 mg lactose (as monohydrate).
Maltese: Kull pillola miksija fiha 233 mg lactose (bħala monohydrate).
English: - priapsim, a prolonged and possibly painful erection after taking CIALIS (frequency rare).
Maltese: - prijapiżmu, erezzjoni fit-tul u possibilment bl-uġigħ wara li tieħu CIALIS (frekwenza rari).
English: In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.
Maltese: Fi studji kliniċi, ġie muri li riociguat jżid l-effetti ipotensivi tal-inibituri ta' PDE5.
English: Skin and subcutaneous tissue disorders
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue
English: Gastrointestinal disorders Dyspepsia
Maltese: Disturbi gastro-intestinali Dispepsja,
English: The mean per-subject proportion of successful sexual intercourse attempts was 68 % for CIALIS patients compared to 52 % for patients on placebo.
Maltese: Il-proporzjon ta' tentattivi ta' kopulazzjoni sesswali b'suċċess għal kull pazjent kien medja ta' 68% għall-pazjenti fuq CIALIS meta mqabbel ma' 52% għall-pazjenti fuq plaċebo.
English: - are taking riociguat.
Maltese: - qed/a tieħu riociguat.