FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/08/457/008 14 film-coated tablets EU/1/08/457/009 28 film-coated tablets EU/1/08/457/010 56 film-coated tablets EU/1/08/457/021 60 film-coated tablets EU/1/08/457/011 112 film-coated tablets EU/1/08/457/012 168 film-coated tablets EU/1/08/457/022 180 film-coated tablets EU/1/08/457/013 196 film-coated tablets EU/1/08/457/014 50 x 1 film-coated tablets EU/1/08/457/016 196 (2 x 98) film-coated tablets EU/1/08/457/018 168 (2 x 84) film-coated tablets
Maltese: EU/1/08/457/008 14-il pillola miksija b'rita EU/1/08/457/009 28 pillola miksija b'rita EU/1/08/457/010 56 pillola miksija b'rita EU/1/08/457/021 60 pillola miksija b'rita EU/1/08/457/011 112-il pillola miksija b'rita EU/1/08/457/012 168 pillola miksija b'rita EU/1/08/457/022 180 pillola miksija b'rita
English: Efficib is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.
Maltese: Efficib huwa indikat bħala terapija tripla kombinata ma' agonist ta' peroxisome proliferator-activated receptor gamma (PPARγ) (jiġifieri, thiazolidinedione) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament b'metformin u agonist ta' PPARγ bid-doża massima ttollerata tagħhom.
English: Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)
Maltese: Frekwenza mhix magħrufa: problemi fil-kliewi (xi drabi jeħtieġu d-dijalisi), rimettar, uġigħ fil-ġogi, uġigħ fil-muskoli, uġigħ fid-dahar, mard tal-interstizju tal-pulmun, pemfigojd bulluż (tip ta' nuffata fil-ġilda)
English: Hepatic impairment Efficib must not be used in patients with hepatic impairment (see section 5.2).
Maltese: Efficib ma' sitagliptin u metformin mgħotijin flimkien (ara sezzjoni 5.2).
English: For the different doses on metformin, Efficib is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
Maltese: Għal dożi differenti ta' metformin, Efficib jinsab bħala 50 mg sitagliptin u 850 mg metformin hydrochloride jew 1,000 mg metformin hydrochloride.
English: Efficib is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Maltese: Efficib huwa indikat f'kumbinazzjoni ma' sulphonylurea (jiġifieri, terapija ta' kumbinazzjoni tripla) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u sulphonylurea.
English: Efficib 50 mg/1,000 mg tablets sitagliptin/metformin HCl
Maltese: Pilloli Efficib 50 mg/1,000 mg sitagliptin/metformin hydrochloride
English: Efficib 50 mg/850 mg tablets sitagliptin/metformin HCl
Maltese: Pilloli Efficib 50 mg/850 mg sitagliptin/metformin hydrochloride
English: Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
Maltese: Kull pillola miksija b'rita (pillola) fiha sitagliptin phosphate monohydrate ekwivalenti għal 50 mg ta' sitagliptin u 850 mg ta' metformin hydrochloride.
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél: +32 (0)27766211 dpoc_belux@merck.com
Maltese: +32(0)27766211 dpoc_belux@merck.com
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 dpoc_czechslovak@merck.com
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204201 msd_slovenia@merck.com
English: EU/1/08/457/009 EU/1/08/457/010 EU/1/08/457/011 EU/1/08/457/012 EU/1/08/457/013 EU/1/08/457/014 EU/1/08/457/016 EU/1/08/457/018 EU/1/08/457/021 EU/1/08/457/022
Maltese: EU/1/08/457/016 EU/1/08/457/018 EU/1/08/457/021 EU/1/08/457/022
English: The dose of antihyperglycaemic therapy with Efficib should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Maltese: Id-doża ta' terapija kontra l-ipergliċemija b'Efficib għandha tkun individwalizzata fuq il-bażi tal-kors kurrenti, l-effettività, u t-tolerabbilità tal-pazjent waqt li ma tinqabiżx id-doża massima ta' kuljum irrakkomandata ta' 100 mg sitagliptin.
English: A bioequivalence study in healthy subjects demonstrated that the Efficib (sitagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Maltese: (sitagliptin/metformin hydrochloride) huma bijoekwivalenti għal għoti konkomitanti ta' sitagliptin phosphate u metformin hydrochloride bħala pilloli individwali.
English: Avoid excessive alcohol intake while taking Efficib since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Maltese: Efficib ma' alkoħol Evita konsum eċċessiv ta' alkoħol waqt li tkun qed tieħu Efficib peress li dan jista' jżid ir-riskju ta'
English: Efficib 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride
Maltese: Efficib 50 mg/850 mg pillola miksija b'rita sitagliptin/metformin hydrochloride
English: Efficib 50 mg/850 mg film-coated tablets
Maltese: Efficib 50 mg/850 mg pilloli miksijin b'rita
English: In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin was CYP3A4, with contribution from CYP2C8.
Maltese: Studji in vitro indikaw li l-enzima primarja responsabbli għall-metaboliżmu limitat ta' sitagliptin kienet CYP3A4, b'kontribuzzjoni minn
English: Efficib is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued during conditions with the potential to alter renal function (see section 4.3).
Maltese: Efficib huwa kontraindikat f'pazjenti b'GFR <30 mL/min u għandu jitwaqqaf temporanjament fil preżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali (ara sezzjoni 4.3).
English: There have been no therapeutic clinical trials conducted with Efficib tablets however bioequivalence of Efficib with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Maltese: Ma saru l-ebda provi terapewtiċi kliniċi b'pilloli Efficib, madankollu ntweriet il-bijoekwivalenza ta' Efficib ma' sitagliptin u metformin mgħotijin flimkien (ara sezzjoni 5.2).
English: When Efficib is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Maltese: sulphonylurea, tista' tkun meħtieġa doża aktar baxxa ta' sulphonylurea biex tnaqqas ir-riskju ta' ipogliċemija (ara sezzjoni 4.4).
English: Efficib should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Maltese: Efficib għandu jingħata darbtejn kuljum mal-ikel sabiex jitnaqqsu r-reazzjonijiet gastrointestinali avversi assoċjati ma' metformin.
English: Efficib 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride
Maltese: Efficib 50 mg/1,000 mg pilloli miksijin b'rita sitagliptin/metformin hydrochloride
English: If no adequate strength of Efficib is available, individual monocomponents should be used instead of the fixed-dose combination.
Maltese: Jekk ma jkun hemm l-ebda qawwa ta' Efficib, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: Sitagliptin 100 mg once daily added to ongoing insulin + metformin therapy (N=223)
Maltese: Sitagliptin 100 mg darba kuljum miżjud ma' terapija konkomitanti b'insulina u metformin 
English: Efficib may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Maltese: Efficib jista' jikkawża effett sekondarju rari ħafna, (jista' jaffettwa sa persuna 1 minn kull 10,000 li qed jużawh), iżda serju ħafna li jissejjaħ aċidożi lattika (ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: Cardiovascular death
Maltese: infart majokardjali reċenti,
English: Patients treated with sitagliptin exhibited a significant mean decrease from baseline in body weight (-1.5 kg) compared to a significant weight gain in patients administered glipizide (+1.1 kg).
Maltese: Pazjenti kkurati b'sitagliptin urew tnaqqis sinifikanti fil-piż (-1.5 kg) mill-medja tal-linja bażi meta imqabbel ma' żieda fil-piż f'pazjenti mogħtijin glipizide (+1.1 kg).
English: Tibolone is a synthetic steroid hormone drug which acts as an agonist, mainly on oestrogen receptors.
Maltese: Tibolone hija mediċina għall-ormoni bi sterojdi sintetiċi li taġixxi bħala agonist, prinċipalment fuq ir-riċetturi tal-estroġenu.
English: • the CHMP reviewed the available data, including the Rapporteurs' assessment reports and the explanations submitted by the Applicant during the CMDh procedure
Maltese: • is-CHMP irreveda d-dejta disponibbli, inklużi r-rapporti ta' valutazzjoni tar-Rapporteurs u lispjegazzjonijiet ppreżentati mill-Applikant matul il-proċedura tas-CMDh
English: A referral under Article 29(4) of Directive 2001/83/EC was triggered and the CHMP was requested to give its opinion on whether the proposed products Tibolona Aristo and Tibocina can be considered bioequivalent to the reference product.
Maltese: Inbeda riferiment skont lArtikolu 29(4) tad-Direttiva 2001/83/KE, u s-CHMP intalab jagħti l-opinjoni tiegħu dwar jekk ilprodotti proposti Tibolona Aristo u Tibocina jistgħux jiġu kkunsidrati bijoekwivalenti għall-prodott ta' referenza.
English: Two applications under the decentralised procedure were submitted for the generic products Tibolona Aristo and Tibocina, both 2.5 mg tablets with the indication “treatment of oestrogen deficiency symptoms in women, more than one year after the menopause”.
Maltese: Żewġ applikazzjonijiet taħt il-proċedura deċentralizzata ġew ippreżentati għall-prodotti ġeneriċi Tibolona Aristo u Tibocina, it-tnejn li huma pilloli ta' 2.5 mg bl-indikazzjoni "kura ta' sintomi marbuta ma' nuqqas ta' estroġenu fin-nisa, aktar minn sena wara l-menopawsa".
English: The CHMP therefore reviewed the additional clinical evidence available, including the assessment carried out during the CMDh procedure and the evidence submitted by the Applicant.
Maltese: Għalhekk, is-CHMP irreveda l-evidenza klinika addizzjonali disponibbli, inkluża l-valutazzjoni mwettqa matul ilproċedura tas-CMDh u l-evidenza ppreżentata mill-Applikant.
English: During the assessment of the application dossiers, a Good Clinical Practice (GCP) inspection of the clinical site identified a lack of evidence documenting the transfer date and time and the identification of pharmacokinetic samples from the dry ice box used for flash freezing to the freezer used at this site until the samples were transferred to the bioanalytical site.
Maltese: Matul ilvalutazzjoni tad-dossiers ta' applikazzjoni, spezzjoni ta' Prassi Klinika Tajba (PKT) tas-sit kliniku identifikat nuqqas ta' evidenza li tiddokumenta d-data u l-ħin tat-trasferiment u l-identifikazzjoni ta' kampjuni farmakokinetiċi mill-kaxxa tas-silġ niexef użata għall-iffriżar malajr tal-friżer użat f'dan is-sit sakemm il-kampjuni jkunu ġew ittrasferiti lejn is-sit bijoanalitiku.
English: • the CHMP considered that the available data confirms that the results of the bioequivalence study are reliable and demonstrate the bioequivalence of the proposed products and the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Tibocina and associated names (see Annex I).
Maltese: • is-CHMP ikkunsidra li d-dejta disponibbli tikkonferma li r-riżultati tal-istudju ta' bijoekwivalenza huma affidabbli u juru l-bijoekwivalenza tal-prodotti proposti u l-prodott ta' referenza is-CHMP irrakkomanda l-għoti tal-awtorizzazzjonijiet għat-tqegħid fis-suq li għalihom is-sommarju tal-karatteristiċi tal-prodott, it-tikkettar u l-fuljett ta' tagħrif jibqgħu skont il-verżjonijiet finali miksuba waqt il-proċedura tal-Grupp ta' Koordinazzjoni kif imsemmi fl-Anness
English: Overall summary of the scientific evaluation of Tibocina and associated names (see Annex I)
Maltese: III għal Tibocina u ismijiet assoċjati (ara Anness I).
English: Having reviewed the available data, the CHMP considered that there was sufficient additional evidence indicating that the study samples were not put at risks during the study and that these were maintained under adequate temperature conditions.
Maltese: Wara li analizza d-dejta disponibbli, is-CHMP ikkunsidra li kien hemm evidenza addizzjonali suffiċjenti li tindika li l-kampjuni tal-istudju ma kinux f'riskju matul l-istudju u li dawn inżammu f'kundizzjonijiet ta' temperatura xierqa.
English: The CHMP acknowledged that the findings are considered as a critical deficiency, however it did not consider that GCP inspection findings classified as critical should automatically invalidate the results of a bioequivalence study.
Maltese: Is-CHMP irrikonoxxa li s-sejbiet huma kkunsidrati bħala nuqqas kritiku, madankollu ma kkunsidrax li s-sejbiet tal-ispezzjoni tal-PKT ikklassifikati bħala kritiċi għandhom jinvalidaw b'mod awtomatiku r-riżultati tal-istudju ta' bijoekwivalenza.
English: The CHMP therefore concluded that while deviations from GCP requirements were identified, the totality of the available evidence confirms that the results of the bioequivalence study are reliable and demonstrates the bioequivalence of the proposed products and the reference product.
Maltese: Għalhekk, is-CHMP ikkonkluda li, filwaqt li kienu identifikati devjazzjonijiet mir-rekwiżiti PKT, ittotalità tal-evidenza disponibbli tikkonferma li r-riżultati tal-istudju ta' bijoekwivalenza huma affidabbli u juru li l-bijoekwivalenza tal-prodotti proposti u l-prodott ta' referenza.
English: HRA Pharma Rare Diseases 200 avenue de Paris 92320 CHATILLON France
Maltese: HRA Pharma Rare Diseases 200 avenue de Paris 92320 CHATILLON Franza
English: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Courron d‘Auvergne France
Maltese: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Courron d‘Auvergne Franza jew
English: Antivirals products Saquinavir (saquinavir/ritonavir 1000/100 mg bid)
Maltese: Saquinavir (saquinavir/ritonavir 1000/100 mg bid)
English: Analgesic opioid Methadone
Maltese: Opioid analġesiku Methadone
English: Immunosuppressants Everolimus Sirolimus (rapamycin)
Maltese: Immunosoppressanti Everolimus Sirolimus (rapamycin)
English: Józefów 9, 99-300 Kutno Poland
Maltese: Józefów 9, 99-300 Kutno Il-Polonja
English: Antiarrhythmics Disopyramide Quinidine
Maltese: Antiarritmiċi Disopyramide Quinidine
English: Vincristine, vinblastine (vinca alkaloids)
Maltese: Vincristine, vinblastine (alkalojdi vinka)
English: Respiratory Drugs Salmeterol
Maltese: Mediċini Respiratorji Salmeterol
English: Urticaria, alopecia
Maltese: Urtikarja, alopeċja
English: • Nervousness
Maltese: • Nervożiżmu
English: Antineoplastics Irinotecan
Maltese: Antineoplastiċi Irinotecan
English: Anticonvulsants Carbamazepine Phenytoin
Maltese: Antikonvulsanti Carbamazepine Phenytoin
English: Each tablet contains 19 mg of lactose (as monohydrate).
Maltese: Kull pillola fiha 19 mg ta' lactose (bħala monohydrate).
English: Antimigraine Drugs Ergots alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)
Maltese: Mediċini kontra lEmigranja Alkalojdi tal-ergotina bħal dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)
English: Potential interaction with medicinal products
Maltese: Interazzjoni potenzjali ma' prodotti mediċinali
English: Lipid Lowering Drugs Lovastatin, simvastatin, atorvastatin*
Maltese: Lovastatin, simvastatin, atorvastatin*
English: Anti-infectives Rifabutin Rifampicin Isoniazid
Maltese: Rifabutin Rifampicin Isoniazid
English: Nevirapine: plasma levels: ↑1.15-1.28fold compared to historical controls
Maltese: Nevirapine: livelli fil-plażma: ↑1.15-1.28 darbiet meta mqabbel mal-kontrolli storiċi
English: HRA Pharma Rare Diseases
Maltese: FIS-SUQ HRA Pharma Rare Diseases
English: PVC/Alu blister of 10 tablets Pack sizes containing 60 tablets (6 blisters of 10 tablets).
Maltese: Pakketti li fihom 60 pillola (6 folji ta' 10 pilloli).
English: At clinically relevant concentrations inhibition of CYP2B6, 2C9/C8, 2C19 and 2D6 by ketoconazole cannot be excluded.
Maltese: F'konċentrazzjonijiet klinikament rilevanti l-inibizzjoni ta' CYP2B6, 2C9/C8, 2C19 u 2D6 permezz ta' ketoconazole ma tistax tiġi eskluża.
English: AUC: ↑ 3.0 to 3.9-fold
Maltese: AUC: ↑ 3.0 sa 3.9 darbiet
English: Other dihydropyridines Verapamil
Maltese: Dihydropyridines oħra Verapamil
English: Doses of 80 and 160 mg/kg inhibited ovulation in immature rats.
Maltese: Dożi ta' 80 u 160 mg/kg impedew l-ovulazzjoni f'firien immaturi.
English: • Allergic reactions which can, rarely, be serious
Maltese: • Reazzjonijiet allerġiċi li, rarament, jistgħu jkunu serji
English: • Intolerance to alcohol
Maltese: • Intolleranza għall-alkoħol
English: Antidiabetics Repaglinide
Maltese: Antidijabetiċi Repaglinide
English: Gastrointestinal Drugs Aprepitant
Maltese: Mediċini gastrointestinali Aprepitant
English: Effects on human reproduction cannot be excluded.
Maltese: Ma jistgħux jiġu esklużi effetti fuq ir-riproduzzjoni umana.
English: Lactose monohydrate Povidone
Maltese: Lamtu tal-qamħirrum Lactose monohydrate Povidone
English: Other medicinal products and Ketoconazole HRA
Maltese: Prodotti mediċinali oħra u Ketoconazole HRA
English: Table 2: Incidence of adverse reactions and marked laboratory abnormalities reported in the literature in adults and adolescents patients
Maltese: Tabella 2: Inċidenza tar-reazzjonijiet avversi u tal-anormalitajiet fir-riżultati tal-laboratorju mmarkati filletteratura f'pazjenti adulti u adolexxenti
English: - Ketoconazole inhibits BCRP (Breast Cancer Resistance Protein) in in vitro studies.
Maltese: - Ketoconazole jinibixxi l-BCRP (Proteina ta' Reżistenza għall-Kanċer tas-Sider) fi studji in vitro.
English: Frequency groupings are defined according to the following convention: 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), very rare (< 1/10,000), not known:
Maltese: komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf: ma tistax tittieħed stima mid-data disponibbli.
English: Ciclesonide active metabolite:
Maltese: Metabolit attiv ta' Ciclesonide:
English: Ketoconazole HRA 200 mg tablets
Maltese: Ketoconazole HRA 200 mg pilloli
English: Urinary free cortisol (UFC) levels were normalised in about 50% of patients on ketoconazole.
Maltese: Il-livelli tal-kortisol liberu fl-awrina (UFC) kienu normalizzati f'madwar 50% tal-pazjenti li kienu qed jieħdu ketoconazole.
English: Use in ectopic Adrenocorticotropic Hormone (ACTH) syndrome
Maltese: Użu fis-sindrome ta' Ormon Adrenokortikotropiku (ACTH) ektopiku
English: Alcohol intolerance, anorexia, increased appetite
Maltese: Intolleranza tal-alkoħol, anoressija, żieda fl-aptit
English: Hepatic impairment Ketoconazole is contraindicated in patients with acute or chronic hepatic impairment (see sections 4.3, 4.4 and
Maltese: Ketoconazole huwa kontraindikat f'pazjenti b'indeboliment epatiku akut jew kroniku (ara sezzjonijiet 4.3, 4.4 u 5.3).
English: Cardiovascular Drugs, Miscellaneous Ranolazine
Maltese: Mediċini kardjovaskulari, Mixxellanji Ranolazine
English: The maximal dose that was used for treatment of Cushing's syndrome is 1,600 mg/day.
Maltese: Id-doża massima li ntużat għall-kura tas-sindrome ta' Cushing hija 1,600 mg/jum.
English: At the last follow-up, clinical signs were improved in 74/134 patients (55.2%), hypertension in 36/90 patients (40), hypokalaemia in 10/26 patients (38.4%), and diabetes mellitus in 23/39 patients (59%).
Maltese: Fl-aħħar segwitu, is-sinjali kienu tjiebu f'74/134 pazjent (55.2%), pressjoni għolja f'36/90 pazjent (40%), ipokalimja f'10/26 pazjent (38.4%), u dijabete mellitus fi 23/39 pazjent (59%).
English: Serious hepatic toxicity caused by ketoconazole treatment is rare (1/15000).
Maltese: Tossiċità epatika serja kkawżata minn kura b'ketoconazole hija rari (1/15000).
English: EU/1/14/965/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/965/001
English: cabazitaxel, crizotinib, ibrutinib - certain medicines used to treat infections: rifabutin, telithromycin, rifampicin, isoniazide, clarithromycin,
Maltese: cabazitaxel, crizotinib, ibrutinib - ċerti mediċini użati għall-kura tal-infezzjonijiet: rifabutin, telithromycin, rifampicin, isoniazide,
English: The overall pharmacological activity of cilostazol increases 35% when coadministered with ketoconazole.
Maltese: L-attività farmakoloġika globali ta' cilostazol tiżdied b'35% meta jingħata flistess ħin ma' ketoconazole.
English: Insomnia, nervousness
Maltese: Nuqqas ta' rqad, nervożiżmu
English: Use in ACTH-independent Cushing's syndrome
Maltese: Użu fis-sindrome ta' Cushing indipendenti mill-ACTH
English: - certain medicines for lowering blood cholesterol: simvastatin, atorvastatin, lovastatin
Maltese: - ċerti mediċini li jbaxxu l-kolesterol fid-demm: simvastatin, atorvastatin, lovastatin
English: At the last visit, 78 patients (49.3%) were controlled, 37 patients (23.4%) had partial control with at least 50% decrease of UFC (without normalisation), and 43 patients (27.2%) had unchanged UFC levels.
Maltese: Fl-aħħar viżta, 78 pazjent (49.3%) kienu kkontrollati, 37 pazjent (23.4%) kellhom kontroll parzjali bi tnaqqis ta' mill-anqas 50% fl-UFC (mingħajr normalizzazzjoni), u 43 pazjent (27.2%) kellhom livelli ta' UFC mhux mibdula.
English: Ketoconazole inhibits primarily the activity of 17α-hydroxylase, but it also inhibits 11-hydroxylation steps, and at higher doses the cholesterol side-chain cleavage enzyme.
Maltese: Ketoconazole jinibixxi primarjament l-attività ta' 17α-hydroxylase, iżda jinibixxi wkoll passi ta' 11-hydroxylation, u f'dożi aktar għoljin il-cholesterol side-chain cleavage enzyme.
English: • Pyrexia (fever)
Maltese: • Piressija (deni)
English: * Rosuvastatin is not a CYP 3A4 substrate.
Maltese: * Rosuvastatin mhuwiex substrat ta' CYP 3A4.
English: At doses > 400 mg/day, half-lives of 3 to 10 hours have been reported.
Maltese: B'dożi ta' > 400 mg/jum, kienu rrappurtati halflives ta' 3 sa 10 sigħat.
English: Musculoskeletal and connective tissue disorder
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi
English: Ketoconazole HRA contains lactose
Maltese: Ketoconazole HRA fih il-lactose
English: • Myalgia (muscle pain)
Maltese: • Majalġja (uġigħ fil-muskoli)
English: Fesoterodine active metabolite:
Maltese: Metabolit attiv ta' Fesoterodine:
English: Ketoconazole is extensively metabolised to a large number of inactive metabolites.
Maltese: Ketoconazole jiġi metabolizzat b'mod estensiv f'numru kbir ta' metaboliti inattivi.
English: Off-white to light cream, round, 10 mm diameter, biconvex.
Maltese: Offwajt għal lewn il-krema ċar, tonda, b'dijametru ta' 10 mm, bikonvessa.
English: • Transient decrease of testosterone, a male hormone (androgen) made by the body,
Maltese: • Tnaqqis temporanju fit-testosteron, ormon tal-irġiel (androġen) magħmul mill-ġisem,
English: AUC: ↑ 2 fold Cmax: ↑ 2 fold
Maltese: AUC: ↑ 2 darbiet Cmax: ↑ 2 darbiet
English: Endocrine disorders Common
Maltese: Disturbi fis-sistema endokrinarja
English: AUC ↑ 12.9 fold
Maltese: Naloxegol AUC ↑ 12.9 darbiet max
English: About 13% of the dose is excreted in the urine, of which 2 to 4% is unchanged medicinal product.
Maltese: Madwar 13% tad-doża tiġi eliminata fl-awrina, li 2 sa 4% minnha tkun prodott mediċinali mhux mibdul.