FrancophonIA/ELRC3.0 huggingface dataset:
English: In this study there were no changes in glucose, insulin, and C-peptide levels.
Maltese: F'dan l-istudju ma kienx hemm tibdiliet fil-glukosju, flinsulina, u fil-livelli tas-C-peptid.
English: LESCOLXL 80 mg Prolonged Release Tablets 80 mg Prolonged-release tablet
Maltese: LESCOLXL 80 mg Prolonged Release Tablets
English: ‘Treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.'
Maltese: ‘Il-kura tal-adulti b'iperkolesterolemija jew b'dislipidemija mħallta, bħala żjieda mad-dieta, meta r-rispons għad-dieta u trattamenti mhux farmakoloġiċi oħrajn (eż. eżerċizzju, tnaqqis fil-piż) ma jkunx adegwat.'
English: Vasculitis
Maltese: Ċipru
English: The CHMP concluded that the following indications are supported by the available data submitted by the MAH:
Maltese: Is-CHMP ikkonkluda li l-indikazzjonijiet li ġejjin huma sostnuti bid-dejta disponibbli sottomessa mill-MAH:
English: Lescol and associated names (see Annex I) 20 mg capsules, hard
Maltese: Lescol u ismijiet assoċjati miegħu (ara Anness I) 20 mg kapsuli, iebsa
English: Biochemical abnormalities of liver function have been associated with HMG-CoA reductase inhibitors and other lipid-lowering agents.
Maltese: Anomaliji bijokimiċi fil-funzjoni tal-kliewi kienu assoċjati ma' inibituri ta' HMC-CoA reductase u ma' aġenti oħrajn li jbaxxu l-lipidi.
English: HOW TO TAKE LESCOL/LESCOL XL
Maltese: QABEL MA TIEĦU LESCOL/LESCOL XL
English: Dose
Maltese: Av.
English: Interstitial lung disease
Maltese: Marda interstizzjali tal-pulmun
English: All patients were started on Lescol capsules 20 mg daily with dose adjustments every 6 weeks to 40 mg daily then 80 mg daily (Lescol 80 mg XL tablet) to achieve an LDL-C goal of < 130 mg/dl (3.4 mmol/l).
Maltese: Il-pazjenti kollha bdew jingħataw kapsuli Lescol ta' 20 mg kuljum b'aġġustament tad-doża kull 6 ġimgħat sa 40 mg kuljum u wara sa 80 mg kuljum (pillola Lescol XL ta' 80 mg) sabiex jintlaħaq l-għan ta' LDL-C ta' < 130 mg/dl (3.4 mmol/l). 70 pazjent kienu laħqu l-età talpubertà jew qabżuha (n=69 kienu evalwati għall-effikaċja).
English: Use reliable contraception for the whole time that you are taking Lescol / Lescol XL.
Maltese: Uża kontraċezzjoni affidabbli matul iż-żmien kollu li fih tkun qed tieħu Lescol/Lescol XL.
English: Vilvoorde, Belgium
Maltese: Vilvoorde Il-Belġju
English: Lescol/Lescol XL has not been investigated and is not intended for the use in children below 9 years.
Maltese: Lescol/Lescol XL ma ġiex investigat u mhux intiż għall-użu fi tfal taħt id-9 snin.
English: The recommendations that women of childbearing potential have to use effective contraception and that treatment should be discontinued from women who become pregnant while taking Lescol/Lescol XL, has been included.
Maltese: Irrakkomandazzjonijiet li n-nisa b'potenzjal li jkollhom it-tfal iridu jużaw kontraċettiv effettiv u li ttrattament għandu jitwaqqaf minn dawk in-nisa li jinqabdu tqal waqt li qed jieħdu Lescol/Lescol XL, ġew inklużi.
English: Do not take Lescol/Lescol XL
Maltese: Jekk tinsa tieħu Lescol/Lescol XL
English: The CHMP agreed with the following wording proposed by the MAH for this indication:
Maltese: Is-CHMP qabel mal-formolazzjoni tal-kliem segwenti proposti mill-MAH għal din l-indikazzjoni:
English: There is consistency across all EU Member States in contraindicating Lescol/Lescol XL for patients with known hypersensitivity to fluvastatin or any of the excipients and in patients with active liver disease, or unexplained, persistent elevations in serum transaminases.
Maltese: Hemm konsistenza mal-Istati Membri tal-UE fil-kontraindikazzjonijiet ta' Lescol/Lescol XL għal pazjenti li għandhom sensittività żejda għal fluvastatin jew għal xi waħda mis-sustanzi mhux attivi u f'pazjenti b'mard tal-fwied attiv, jew elevazzjonijiet persistenti, mhux spjegati tat-transaminases fisserum.
English: The analyses from the Lescol pooled clinical trial database and the ALERT study presented by the MAH has provided further data regarding the efficacy and safety of fluvastatin 40-80mg in patients with renal impairment.
Maltese: L-analiżi mid-database tal-provi kliniċi miġbura flimkien ta' Lescol u l-istudju ALERT ippreżentat mill-MAH ipprovdew aktar dejta rigward l-effikaċja u s-sigurtà ta' fluvastatin tal-40-80 mg f'pazjenti b'indeboliment renali.
English: Children and adolescents with heterozygous familial hypercholesterolaemia Prior to initiating treatment with Lescol/Lescol XL in children and adolescents aged 9 years and older with heterozygous familial hypercholesterolaemia, the patient should be placed on a standard cholesterollowering diet, and continued during treatment.
Maltese: Tfal u adoloxxenti b'iperkolesterolemija familjari eterozigote Qabel ma tinbeda l-kura b'Lescol/Lescol XL fi tfal u adoloxxenti li għandhom 9 snin u aktar b'iperkolesterolemija familjari eterozigote, il-pazjent għandu jibda dieta standard li tnaqqas ilkolesterol u din għandha tissokta waqt il-kura.
English: The most commonly reported adverse reactions are mild gastrointestinal symptoms, insomnia and headache.
Maltese: L-iktar reazzjonijiet avversi rrappurtati b'mod komuni huma sintomi gastrointestinali ħfief, insomnja u uġigħ ta' ras.
English: Section 4.2 - Posology and method of administration
Maltese: Sezzjoni 4.6 - Tqala u treddigħ
English: Rifampicin
Maltese: Il-kolkiċini
English: Liposit Prolib 80
Maltese: Liposit Prolib 80 mg
English: - The dose range for adults is 20 to 80 mg per day and depends on the extent of cholesterol lowering which needs to be achieved.
Maltese: • Id-dożaġġ għall-adulti għandu jkun bejn 20 u 80 mg kuljum u jiddependi mill-ammont li għandu jiġi milħuq fit-tbaxxija tal-kolesterol.
English: The results from another study in which Lescol XL tablets (80 mg fluvastatin) was administered to renal transplant patients who were on stable ciclosporin regimen showed that fluvastatin exposure (AUC) and maximum concentration (Cmax) were increased 2-fold compared to historical data in healthy subjects.
Maltese: Irriżultati miksuba minn studju ieħor li fih il-pilloli Lescol XL (80 mg fluvastatin) ingħataw lil pazjenti bi trapjant tal-kliewi li kienu qed jingħataw kura fissa biċ-ċiklosporina wrew li l-espożizzjoni għallfluvastatin (AUC) u l-konċentrazzjoni massima (Cmax) għolew b'darbtejn meta mqabbel malinformazzjoni storika f'suġġetti b'saħħithom.
English: Lescol XL prolonged release tablet 80 mg 80 mg Prolonged-release tablet
Maltese: Lescol XL Prolonged release tablet 80 mg
English: 40 mg
Maltese: Vaditon 40 mg
English: Creatine kinase measurement
Maltese: Kejl tal-kreatina kinasi
English: Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland
Maltese: Novartis Finland OY Metsänneidonkuja 10
English: Hepatobiliary disorders Very rare:
Maltese: Disturbi fil-fwied u fil-marrara Rari ħafna:
English: Dose titration intervals
Maltese: Intervalli tat-titrazzjoni tad-doża
English: Novartis Hungária Kft. Pharma
Maltese: Qawwa Għamla Farmaċewtika
English: Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8).
Maltese: Ġew irrapurtati każijiet eċċeżżjonali ta' mard interstizzjali tal-pulmun b'xi statini, speċjalment bilkura fit-tul (ara s-sezzjoni 4.8).
English: Liposit 40 mg caps
Maltese: Liposit 40 mg
English: Marked elevations of CK levels to more than 5x ULN developed in a very small number of patients (0.3 to 1.0%).
Maltese: Kien hemm żidiet f'daqqa ta' aktar minn 5x ULN fil-livelli tas-CK li seħħew f'għadd żgħir ħafna ta' pazjenti (bejn 0.3 u 1.0%).
English: For patients requiring LDL-C reduction to a goal of ≥25%, the recommended starting dose is 40 mg as one capsule in the evening.
Maltese: Għal pazjenti li jeħtieġu tnaqqis LDL-C għal mira ta' ≥25%, tista' tintuża doża inizjali ta' 40 mg bħala kapsula waħda filgħaxija.
English: What Lescol/Lescol XL looks like and contents of the pack [To be completed nationally]
Maltese: Id-dehra ta' Lescol/Lescol XL u l-kontenuti tal-pakkett [Biex timtela mill-pajjiż partikolari]
English: Lescol 40 mg caps
Maltese: Lescol caps. 40 mg
English: The pharmacokinetics of fluvastatin remain unchanged in patients with mild to severe renal insufficiency.
Maltese: Il-farmakokinetiċi ta' fluvastatin f'pazjenti b'insuffiċjenza renali ħafifa sa severa jibqgħu mhux mibdula.
English: − Your doctor can also prescribe Lescol/ Lescol XL to prevent further serious cardiac events (e.g. heart attack) in patients after they already went through a heart catheterisation, with an intervention in the heart vessel.
Maltese: − It-tabib tiegħek jista' wkoll jippreskrievi Lescol/Lescol XL sabiex jipprevjeni aktar episodji kardijaċi serji (eż. attakk tal-qalb) f'pazjenti li jkunu diġà għamlu kateterizzazzjoni tal-qalb b'intervent fil-vini u l-arterji tal-qalb.
English: 114 patients (66 boys and 48 girls) were treated with fluvastatin administered as either Lescol capsules (20 mg/day to 40 mg twice daily) or Lescol XL 80 mg prolonged-release tablets once daily using a dose-titration regimen based upon LDL-C response.
Maltese: Lescol u ismijiet assoċjati miegħu (ara Anness I) 20 mg kapsuli, iebsa Lescol u ismijiet assoċjati miegħu (ara Anness I) 40 mg kapsuli, iebsa Lescol XL u ismijiet assoċjati miegħu (ara Anness I) 80 mg pilloli li jerħu l-mediċina bil-mod
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: It is given by a veterinarian.
Maltese: Jingħata minn veterinarju.
English: Recuvyra is a medicine that contains the active substance fentanyl.
Maltese: Recuvyra hija mediċina li fiha s-sustanza attiva fentanyl.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Recuvyra on 6 October 2011.
Maltese: Il-Kummissjoni Ewropea ħarġet awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Recuvyra fis-6 ta' Ottubru 2011.
English: The active substance in Recuvyra, fentanyl, is an opioid painkiller.
Maltese: Is-sustanza attiva f'Recuvyra, fentanyl, hija opjojde għas-serħan mill-uġigħ.
English: Diarrhoea and vomiting are also common side effects.
Maltese: Dijarrea u rimettar huma wkoll effetti sekondarji komuni.
English: What is Recuvyra?
Maltese: X'inhu Recuvyra?
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni fuq il-bażi tar-rakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: Why has Recuvyra been approved?
Maltese: Għaliex ġie approvat Recuvyra?
English: The recommended dose is 2.6 mg per kilogram bodyweight applied with a specially designed syringe to the skin between the shoulder blades of the dog.
Maltese: Id-doża rakkomandata hija 2.6 mg għal kull kilogramma piż tal-ġisem, applikata b'siringa ddisinjata b'mod speċjali fuq il-ġilda bejn l-ispallejn tal-kelb.
English: It is available as a transdermal solution (a solution applied to the skin).
Maltese: Jiġi bħala soluzzjoni transdermali (soluzzjoni applikata fuq il-ġilda).
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ benefiċċju-riskju jinsab fil-modulu taddiskussjoni xjentifika ta' dan l-EPAR.
English: Recuvyra very commonly causes sleepiness which may last for more than 24 hours after applying the medicine, and which can be associated with reduced food and water intake, decreased stool production and transient weight loss.
Maltese: Spiss, Recuvyra jikkawża ħedla li tista' ddum aktar minn 24 siegħa wara li jiġi applikat il-prodott mediċinali, u li tista' tiġi assoċjata ma' konsum inqas ta' ikel u ilma, tnaqqis fil-produzzjoni tal-ippurgar u telf temporanju fil-piż.
English: The studies compared the two medicines in terms of failure rate (dogs that had to be taken off treatment due to lack of pain control) and the need for additional treatment to counteract the harmful effects of opioid medicines.
Maltese: L-istudji qabblu ż-żewġ mediċini f'termini ta' rata ta' falliment (klieb li kellhom jitneħħew mit-trattament minħabba nuqqas ta' kontroll tal-uġigħ) u l-ħtieġa għal trattament addizzjonali bħala azzjoni kontra l-effetti ta' ħsara tal-prodotti mediċinali bl-opijodi.
English: The person administering Recuvyra should avoid contact with their skin as the medicine can be absorbed by human skin and may cause reactions in people, including skin irritation.
Maltese: Il-persuna li tamministra Recuvyra għandha tevita kuntatt mal-ġilda tagħha minħabba li l-mediċina tista' tiġi assorbita mill-ġilda tal-bniedem u tista' tikkawża reazzjonijiet fin-nies, inkluża irritazzjoni talġilda.
English: Contact with the dog's skin after application of Recuvyra should not cause problems for adults.
Maltese: Kuntatt mal-ġilda tal-kelb wara l-applikazzjoni ta' Recuvyra m'għandux jikkawża problemi għall-adulti.
English: In two main studies, dogs undergoing orthopaedic or soft tissue surgery were either given Recuvyra or buprenorphine (another opioid painkiller) in advance of surgery to control their pain.
Maltese: F'żewġ studji ewlenin, klieb li kienu għaddejjin minn kirurġija ortopedika jew fit-tessuti rotob ingħataw Recuvyra jew buprenorphine (prodott mediċinali għas-serħan mill-uġigħ bl-opijodu) qabel il-kirurġija sabiex jiġi kkontrollat l-uġigħ tagħhom.
English: What is the risk associated with Recuvyra?
Maltese: X'inhu r-riskju assoċjat ma' Recuvyra?
English: The most common symptoms associated with fentanyl overdose in people include respiratory depression, sleepiness and myosis (narrowing of the pupil in the eye).Protective equipment of clothing should be used when handling the medicine.
Maltese: Is-sintomi l-aktar komuni assoċjati ma' doża eċċessiva ta' fentanyl fin-nies jinkludu dipressjoni respiratorja, ħedla u mijożi (tidjiq tal-ħabba tal-għajn).
English: Recuvyra is used to control pain in dogs that have undergone major orthopaedic (bone) or soft tissue surgery.
Maltese: Recuvyra jintuża biex jikkontrolla l-uġigħ fil-klieb li jkunu għaddew minn kirurġija ortopedika maġġuri (tal-għadam) jew kirurġija tat-tessut artab.
English: Other side effects include mild reductions in body temperature, heart rate and breathing rate for up to three days following use.
Maltese: Effetti sekondarji oħra jinkludu tnaqqis ħafif fit-temperatura tal-ġisem, fir-rata tat-tħabbit tal-qalb u fir-rata tat-teħid tan-nifs sa tliet ijiem wara l-użu.
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR).
English: The CVMP decided that the benefits of Recuvyra outweighed its risks and recommended that it be given a marketing authorisation.
Maltese: Is-CVMP iddeċieda li l-benefiċċji ta' Recuvyra huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: Informazzjoni dwar l-istatus tal-preskrizzjoni ta' dan il-prodott tinsab fuq it-tikketta/il-pakkett ta' barra.
English: When applied to the skin of dogs, a dose of fentanyl is rapidly absorbed into the blood stream through the blood vessels below the skin.
Maltese: Meta applikata fuq il-ġilda tal-klieb, doża ta' fentanyl tiġi assorbita b'mod rapidu fis-sistema tal-fluss tad-demm permezz ta' vini u arterji tad-demm taħt il-ġilda.
English: In both studies Recuvyra was as effective as the comparator medicine in treating pain in dogs following orthopaedic or soft tissue surgery.
Maltese: Fiż-żewġ studji, Recuvyra kien effettiv daqs il-mediċina tat-tqabbil fit-trattament tal-uġigħ fil-klieb li kienu qegħdin isegwu kirurġija ortopedika jew fit-tessuti rotob.
English: What benefit has Recuvyra shown during the studies?
Maltese: X'benefiċċju wera Recuvyra matul l-istudji?
English: 15 March 2012
Maltese: Marzu 15, 2012
English: It was to be available as an oral suspension (125 mg/ml).
Maltese: Kellu jiġi f'sospensjoni orali (125 mg/ml).
English: Megestrol Alkermes was assessed as a ‘hybrid generic medicine'.
Maltese: Megestrol Alkermes ġie vvalutat bħala ‘mediċina ġenerika ibrida'.
English: Megestrol Alkermes is a medicine that contains the active substance megestrol.
Maltese: Megestrol Alkermes huwa mediċina li fiha s-sustanza attiva megestrol.
English: What is Megestrol Alkermes?
Maltese: X'inhu Megestrol Alkermes?
English: The active substance in Megestrol Alkermes, megestrol, is similar to a naturally occurring hormone called progesterone and is used in the treatment of certain cancers.
Maltese: Is-sustanza attiva f'Megestrol Alkermes, il-megestrol, hija simili għall-ormon naturali progesterone, u tintuża filkura ta' ċerti kankri.
English: On 6 March 2012, Alkermes Pharma Ireland Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Megestrol Alkermes, intended to treat weight loss and loss of appetite in patients with cancer or AIDS.
Maltese: Fis-6 ta' Marzu 2012, Alkermes Pharma Ireland Ltd. innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għal awtorizzazzjoni għattqegħid fis-suq għal Megestrol Alkermes, li huwa prodott mediċinali maħsub biex jikkura t-telf tal-piż u tal-aptit f'pazjenti morda bil-kanċer u bl-AIDS.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Maltese: Dan ifisser li s-CHMP ivvaluta d-dokumentazzjoni mressqa mill-kumpanija u ħejja lista ta' mistoqsijiet.
English: Megestrol Alkermes is expected to work in the same way as the reference medicine, Megace.
Maltese: Megestrol Alkermes mistenni jaħdem bl-istess mod bħall-mediċina ta' referenza, Megace.
English: Because Megestrol Alkermes was assessed as a hybrid generic medicine, the company presented the results of studies carried out to investigate whether it is bioequivalent to the reference medicine, Megace.
Maltese: Ġaladarba Megestrol Alkermes ġie vvalutat bħala mediċina ġenerika ibrida, il-kumpanija ppreżentat irriżultati tal-istudji li saru biex jistħarrġu jekk huwiex bijoekwivalenti għall-mediċina ta' referenza, Megace.
English: The company also presented a study investigating the effectiveness of Megestrol Alkermes in the treatment of weight loss and loss of appetite in patients with AIDS and data from the scientific literature supporting the use of megestrol in the treatment of weight loss and loss of appetite in patients with cancer and AIDS.
Maltese: Il-kumpanija ppreżentat ukoll studju li stħarreġ l-effikaċja ta' Megestrol Alkermes fil-kura tattelf tal-piż u tal-aptit f'pazjenti morda bil-kanċer u bl-AIDS u data minn dokumentazzjoni xjentifika li tappoġġa l-użu tal-megastrol fil-kura tat-telf tal-piż u tal-aptit f'pazjenti morda bil-kanċer u bl-AIDS.
English: Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Megestrol Alkermes could not have been approved.
Maltese: Skont l-analiżi tad-data u t-tweġibiet mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fiżżmien tal-irtirar is-CHMP wera xi tħassib u kellu l-opinjoni proviżorja li Megestrol Alkermes ma setax jiġi approvat.
English: How is Megestrol Alkermes expected to work?
Maltese: Għal xiex kien mistenni jintuża Megestrol Alkermes?
English: Based on the data submitted, the CHMP was of the opinion that the studies did not show that Megestrol Alkermes was bioequivalent to the reference medicine and therefore cannot be considered to have the same effectiveness as Megace in reversing weight loss and loss of appetite in patients with cancer and AIDS.
Maltese: Abbażi tad-data mressqa, is-CHMP kien tal-fehma li l-istudji ma wrewx li Megestrol Alkermes kien tabilħaqq bijoekwivalenti għall-mediċina ta' referenza u li għaldaqstant ma setax jitqies li dan kien effikaċi daqs Megace fl-irġiegħ lura tat-telf tal-piż u tal-aptit f'pazjenti morda bil-kanċer u bl-AIDS.
English: This means that it was intended to be similar to a ‘reference medicine' called Megace which is already authorised in the European Union and contains the same active substance.
Maltese: Dan ifisser li kien maħsub biex ikun simili għal ‘mediċina ta' referenza' msejħa Megace li hija diġà awtorizzata fl-Unjoni Ewropea u li fiha listess sustanza attiva.
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU- - BARCODE 2D
English: Urticaria,
Maltese: Urtikarja,
English: Peripheral oedema,
Maltese: Edema periferali,
English: Myalgia,
Maltese: Mijalġja,
English: Komárom, 2900 Hungary
Maltese: Komárom, 2900
English: Mylan UK Healthcare Limited Building 20, Station Close Potters Bar, EN6 1TL United Kingdom
Maltese: Mylan UK Healthcare Limited Building 20, Station Close Potters Bar, EN6 1TL Ir-Renju Unit
English: - phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
Maltese: - phenobarbital, phenytoin u carbamazepine (mediċini kontra l-aċċessjonijiet)
English: Pack sizes of 14, 28, 30, 56, 84 and 98 tablets.
Maltese: Daqsijiet tal-pakkett ta' 14, 28, 30, 56, 84 u 98 pillola.
English: Generics [UK] Limited Station Close Potters Bar, EN6 1TL United Kingdom
Maltese: Generics [UK] Limited Station Close Potters Bar, EN6 1TL Ir-Renju Unit
English: 5-alpha reductase inhibitors
Maltese: Inibituri ta' 5-alpha reductase
English: Dyspnoea, Epistaxis
Maltese: Qtugħ ta' nifs, Epistassi
English: България (Bulgaria) Майлан ЕООД Тел: + 359 2 44 55 400
Maltese: Майлан ЕООД Тел: + 359 2 44 55 400
English: Κύπρος (Cyprus) Varnavas Hadjipanayis LtdTel: + 357 222 077 23
Maltese: Κύπρος (Cyprus) Varnavas Hadjipanayis Ltd Τηλ: +357 222 077 23
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 CYP2C19.
English: Pack sizes of 28 and 56 tablets.
Maltese: Daqsijiet tal-pakkett ta' 28 u 56 pillola.
English: Pack sizes of 4, 12 and 24 tablets.
Maltese: Daqsijiet tal-pakkett ta' 4, 12 u 24 pillola.
English: Tablet core: lactose anhydrous (see section 2 ‘Tadalafil Mylan contains lactose'), poloxamer 188, cellulose microcrystalline (pH101), povidone (K-25), croscarmellose sodium, magnesium stearate, sodium laurilsulfate, silica colloidal anhydrous.
Maltese: Qalba tal-pillola: lactose anhydrous (ara sezzjoni 2 ‘Tadalafil Mylan fih il-lactose'), poloxamer 188, cellulose microcrystalline (pH101), povidone (K-25), croscarmellose sodium, magnesium stearate, sodium laurilsulfate, silica colloidal anhydrous.
English: Myocardial infarction, Unstable angina pectoris Ventricular arrhythmia
Maltese: Infart mijokardijaku, Anġina pectoris instabbli
English: Gastrointestinal disorders Dyspepsia
Maltese: Disturbi gastrointestinali
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 fil-mixi 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 filgrupp ta' tadalafil 0.3 mg/kg (p = 0.307) u -59.1 m fil-grupp ta' tadalafil 0.6 mg/kg (p = 0.538).
English: Transient ischaemic attacks Migraine
Maltese: Attakki iskemiċi temporanji Emigranja
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%.