FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardiac disorders
Maltese: Funzjoni adrenali
English: INHALER
Maltese: Salmeterol
English: The data from the study indicated that regardless of age and underlying disease severity, children, adolescents and adults with asthma as well as patients with COPD were able to achieve inspiratory flow rates through the Spiromax device that were similar to those generated through the marketed multi-dose dry powder inhaler device.
Maltese: Id-data mill-istudju indikat li irrispettivament mill-età u mis-severità tal-marda eżistenti, tfal, adolexxenti u adulti bl-ażżma kif ukoll pazjenti b'COPD kienu kapaċi jiksbu rati ta' fluss inspiratorju permezz tal-apparat Spiromax li kienu simili għal dawk iġġenerati permezz ta' apparat għat-teħid man-nifs b'dożi multipli ta' trab niexef diġà fuq is-suq.
English: Salmeterol is a selective long-acting (12 hour) β2 adrenoceptor agonist with a long side chain which binds to
Maltese: Salmeterol huwa agonist selettiv li jaħdem fit-tul (12-il siegħa) tar-riċetturi β2 adrenerġiċi b'katina tal-ġenb twila li teħel ma' exo-sit tar-riċettur.
English: Each Aerivio Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent yellow
Maltese: Kull inalatur Aerivio Spiromax fih 60 inalazzjoni u huwa abjad b'għatu tal- parti li titqiegħed fil-ħalq isfar semi-trasparenti.
English: Tel: +370 5 266 02 03
Maltese: UAB “Sicor Biotech” Tel: +370 5 266 02 03
English: In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%.
Maltese: Fi studju żgħir f'voluntiera f'saħħithom, ketoconazole, inibitur ta' CYP3A ftit inqas potenti żied lesponiment għal fluticasone propionate wara inalazzjoni waħda b'150%.
English: The pharmacological effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
Maltese: L-effetti farmakoloġiċi ta' trattament b'agonisti tar-riċetturi β2, bħal rogħda, palpitazzjonijiet u uġigħ ta' ras, ġew irrappurtati, iżda għandhom tendenza li jkunu temporanji u jonqsu b'terapija regolari.
English: The following side effects have also been reported in patients with chronic obstructive pulmonary disease (COPD):
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati wkoll f'pazjenti b'marda kronika ostruttiva tal-pulmun (COPD - chronic obstructive pulmonary disease):
English: Moderate/ severe exacerbations were defined as worsening symptoms that required treatment with oral corticosteroids and/or antibiotics or in-patient hospitalisation.
Maltese: Episodji ta'rkadar moderat/sever kienu definiti bħala aggravar ta' sintomi li jeħtieġ trattament b'kortikosterojdi orali u/jew antibijotiċi jew dħul l-isptar.
English: Patients should be given a strength of salmeterol/fluticasone propionate inhaler containing the appropriate fluticasone propionate dosage for the severity of their disease.
Maltese: Mhux magħruf jekk salmeterol u fluticasone propionate/metaboliti jiġux eliminati fil-ħalib tas-sider talbniedem.
English: Placebo-controlled clinical trials, over 6 and 12 months, have shown that regular use of salmeterol/fluticasone propionate 50/500 micrograms improves lung function and reduces breathlessness and
Maltese: Provi kliniċi kkontrollati bil-plaċebo, fuq 6 u 12-il xahar, urew li l-użu regolari ta' salmeterol/fluticasone propionate 50/500 mikrogramma itejjeb il-funzjoni tal-pulmun u jnaqqas il-qtugħ ta' nifs u l-użu ta' medikazzjoni ta' serħan.
English: The average improvement over three years for salmeterol/fluticasone propionate compared with placebo was -3.1 units (95% CI: -4.1 to -2.1; p<0.001) and when compared with salmeterol was -2.2 units (p<0.001) and when compared with FP was -1.2 units (p=0.017).
Maltese: It-titjib medju fuq tliet snin għal salmeterol/fluticasone propionate mqabbel mal-plaċebo kien ta' -3.1 unitajiet (CI ta' 95%: -4.1 sa -2.1; p<0.001) u meta mqabbel ma' salmeterol kien ta' -2.2 unitajiet (p<0.
English: *Well controlled asthma was achieved more rapidly with salmeterol/fluticasone propionate than with ICS alone.
Maltese: *Ażżma ikkontrollata tajjeb inkisbet aktar malajr b'salmeterol/fluticasone propionate milli b'ICS waħdu.
English: Close the mouthpiece cover.
Maltese: Mhux applikabbli.
English: The use of concurrent inhaled long-acting β2 agonists and anticholinergic drugs, salbutamol/ipratropium bromide combination products, oral β2 agonists and theophylline preparations were not allowed during the treatment period.
Maltese: Ġew irrappurtati effetti farmakoloġiċi ta' trattament b'agonist tar-riċetturi β2, bħal rogħda, palpitazzjonijiet u uġigħ ta' ras, iżda dawn għandhom tendenza li jkunu temporanji u jonqsu b'terapija regolari.
English: In animal reproduction studies, glucocorticosteroids have been shown to induce malformations (cleft palate, skeletal malformations).
Maltese: Fi studji dwar ir-riproduzzjoni fl-annimali, glukokortikosterojdi intwerew li jwasslu għal malformazzjonijiet (palat mixquq, malformazzjonijiet skeletriċi).
English: There was a trend towards improved survival in subjects treated with salmeterol/fluticasone propionate compared with placebo over 3 years however this did not achieve the statistical significance level p≤0.05.
Maltese: Kien hemm tendenza lejn sopravivenza mtejba f'individwi ttrattati b'salmeterol/fluticasone propionate meta mqabbel mal-plaċebo fuq 3 snin iżda dan ma kisibx il-livell statistikament sinifikanti p≤0.05.
English: This may lead to an increase in the incidence of systemic effects (e.g. prolongation in the QTc interval and palpitations).
Maltese: Dan jista' jwassal għal żieda fl-inċidenza ta' effetti sistemiċi (eż. titwil fl-intervall QTc u palpitazzjonijiet).
English: Concomitant use of systemic ketoconazole significantly increases systemic exposure to salmeterol.
Maltese: L-użu flimkien ma' ketoconazole sistemiku jżid b'mod sinifikanti l-esponiment sistemiku għal salmeterol.
English: • Check the dose indicator to see that there are 60 inhalations in the inhaler.
Maltese: • Iċċekkja l-indikatur tad-doża biex tara li hemm 60 inalazzjoni fl-inalatur.
English: Salmeterol produces a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting β2 agonists.
Maltese: Salmeterol jipproduċi żmien itwal ta' bronkodilatazzjoni, li ddum għal mill-inqas 12-il siegħa, meta mqabbel ma' dożi rakkomandati ta' agonisti tar-riċetturi β2 konvenzjonali li jaħdmu għal żmien qasir.
English: The trials had a 4 week run-in period during which all subjects received open-label salmeterol/FP 50/250 to standardize COPD pharmacotherapy and stabilise disease prior to randomisation to blinded study medication for 52 weeks.
Maltese: Il-provi kellhom perjodu ta' introduzzjoni ta' 4 ġimgħat li matulu l-individwi kollha rċevew salmeterol/FP 50/250 open-label biex tiġi standardizzata l-farmakoterapija ta' COPD u tiġi stabilizzata l-marda qabel randomisation għall-medikazzjoni blinded tal-istudju għal 52 ġimgħa.
English: The signs and symptoms of salmeterol overdose are dizziness, increases in systolic blood pressure, tremor, headache and tachycardia.
Maltese: Is-sinjali u s-sintomi ta' doża eċċessiva ta' salmeterol huma sturdament, żidiet fil-pressjoni sistolika taddemm, rogħda, uġigħ ta' ras u takikardija.
English: Oral infections
Maltese: .2 Inkompatibbiltajiet
English: Patients with severe lactose intolerance should use this medicine with caution and those with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti b'intolleranza severa għal lactose għandhom jużaw din ilmediċina b'kawtela u dawk li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
Maltese: Inalazzjoni waħda ta' 50 mikrogramma salmeterol u 500 mikrogramma fluticasone propionate darbtejn kuljum.
English: • Diabetes mellitus (Aerivio Spiromax may increase your blood sugar)
Maltese: • Dijabete mellitus (Aerivio Spiromax jista' jżid iz-zokkor fid-demm tiegħek)
English: The increased incidence of reported pneumonia with salmeterol/fluticasone propionate 50/250 micrograms twice daily appears to be of similar magnitude to the incidence reported following treatment with salmeterol/fluticasone propionate 50/500 micrograms twice daily in TORCH.
Maltese: L-inċidenza akbar ta' pulmonite irrappurtata b'salmeterol/fluticasone propionate 50/250 mikrogramma darbtejn kuljum tidher li hija ta' kobor simili għall-inċidenza irrappurtata wara trattament b'salmeterol/fluticasone propionate 50/500 mikrogramma darbtejn kuljum f'TORCH.
English: If Aerivio Spiromax therapy has to be withdrawn due to overdose of the β agonist component of the medicinal product, provision of appropriate replacement steroid therapy should be considered.
Maltese: Jekk it-terapija b'Aerivio Spiromax ikollha tiġi mwaqqfa minħabba doża eċċessiva tal-komponent agonist tar-riċetturi β tal-prodott mediċinali, għandha tiġi kkunsidrata proviżjoni ta' terapija xierqa ta' sostituzzjoni ta' sterojdi.
English: If you are using Aerivio Spiromax for asthma, your doctor will want to check your symptoms regularly.
Maltese: Il-frekwenzi ġew derivati minn data minn provi kliniċi.
English: Side panel: For use in adults 18 years of age and older only.
Maltese: Għal użu f'adulti ta' età minn 18-il sena 'l fuq biss.
English: - The active substances are salmeterol and fluticasone propionate.
Maltese: X'fih Aerivio Spiromax - Is-sustanzi attivi huma salmeterol u fluticasone propionate.
English: • Low blood pressure and seizures (fits)
Maltese: Sintomi respiratorji (qtugħ ta' nifs)
English: To prevent these symptoms, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).
Maltese: Biex jipprevjeni dawn is-sintomi, it-tabib tiegħek jista' jippreskrivilek aktar kortikosterojdi forma ta' pilloli (bħal prednisolone).
English: Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics.
Maltese: Kawtela partikolari hija rakkomandata f'ażżma akuta severa għax dan l-effett jista' jitqawwa permezz ta' trattament flimkien ma' derivattivi ta' xanthine, sterojdi u dijuretiċi.
English: • Depression or aggression (although these effects are more likely to occur in children when prescribed this combination of drugs but in a lower strength).
Maltese: • Depressjoni jew aggressjoni (għalkemm dawn l-effetti huma aktar probabbli li jseħħu fit-tfal meta jiġu preskritti din il-kombinazzjoni ta' mediċini iżda b'qawwa aktar baxxa).
English: Symptomatic candidiasis of the mouth and throat can be treated with topical anti-fungal therapy whilst still continuing with Aerivio Spiromax.
Maltese: Kandidjasi sintomatika tal-ħalq u l-gerżuma tista' tiġi ttrattata b'terapija topika kontra l-fungi waqt li jitkompla Aerivio Spiromax.
English: Aerivio Spiromax contains salmeterol and fluticasone propionate, which have differing modes of action.
Maltese: Mekkaniżmu ta' azzjoni u effetti farmakodinamiċi Aerivio Spiromax fih salmeterol u fluticasone propionate, li għandhom modi ta'azzjoni differenti.
English: There are no data available from clinical trials on overdose with Aerivio Spiromax, however data on overdose with both active substances are given below:
Maltese: M'hemmx data disponibbli minn provi kliniċi dwar doża eċċessiva b'Aerivio Spiromax, madankollu data dwar doża eċċessiva biż-żewġ sustanzi attivi hija mogħtija hawn taħt:
English: This leaflet was last revised in month YYYY.
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: Suomi/Finland Teva FinlandPuh/Tel: +358 20 180 5900
Maltese: Pliva Hrvatska d.o.o Tel: + 385 1 37 20 000
English: Aerivio Spiromax is for the treatment of patients with severe asthma only.
Maltese: Aerivio Spiromax jista' ma jkunx adattat biex jittieħed ma' xi mediċini oħra.
English: This medicinal product contains lactose.
Maltese: Dan il-prodott mediċinali fih lactose.
English: It is very important that you take your Aerivio Spiromax every day as directed.
Maltese: Huwa importanti ħafna li tieħu Aerivio Spiromax tiegħek kuljum kif ordnat.
English: PC: SN: NN:
Maltese: Puh /Tel:
English: In TORCH, older patients, patients with a lower body mass index (<25 kg/m2) and patients with very severe disease (FEV1<30% predicted) were at greatest risk of developing pneumonia regardless of treatment.
Maltese: F'TORCH, pazjenti ta' età akbar, pazjenti li għandhom indiċi tal-massa tal-ġisem aktar baxx (<25 kg/m2) u pazjenti b'marda severa ħafna (FEV1<30% ta' dak imbassar) kellhom l-akbar riskju li jiżviluppaw pulmonite irrispettivament mit-trattament.
English: It is important to inhale forcefully to ensure optimal dosing.
Maltese: L/min wara taħriġ ottimali.
English: Not for use in children or adolescents under 18 years of age.
Maltese: M'għandux jintuża fi tfal u adolexxenti ta' età inqas minn 18-il sena.
English: • Bruising and fractures.
Maltese: • Uġigħ fis-sider.
English: Aerivio Spiromax affecting your adrenal glands.
Maltese: Aerivio Spiromax huwa għall-użu f'pazjenti b'ażżma severa biss.
English: Frequency not known, but may also occur:
Maltese: Frekwenza mhux magħrufa, iżda jistgħu jseħħu wkoll:
English: Lietuva UAB “Sicor Biotech”
Maltese: Тева Фармасютикълс България ЕООД Teл:
English: The primary endpoint in SMART was the combined number of respiratory-related deaths and respiratory-related life-threatening experiences.
Maltese: Il-punt tat-tmiem primarju fi SMART kien in-numru kkombinat ta' mwiet relatati mar-respirazzjoni u esperjenzi ta' periklu għal ħajja relatati mar-respirazzjoni.
English: Palpitations
Maltese: Bronkite
English: The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid undesirable effects.
Maltese: Il-kombinazzjoni għandha tiġi evitata sakemm il-benefiċċju ma jkunx akbar miż-żieda fir-riskju ta' effetti mhux mixtieqa sistemiċi talglukokortikojdi.
English: Read the package leaflet carefully before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: (see section 5.1).
Maltese: (ara sezzjoni 5.1).
English: N % Δ N % Δ N % Δ N % Δ N % Δ
Maltese: N % ΔN % Δ N % ΔN % Δ N % Δ
English: Av. Diagonal, 507
Maltese: Diagonal, 507
English: 1235 Wien, Austria
Maltese: 1235 Wien
English: U Nákladového nádraží 10, 13000 Prague 3, Czech Republic
Maltese: U Nákladového nádraží 10 13000 Prague 3
English: 6800 LZ Arnhem The Netherlands
Maltese: 6800 LZ Arnhem L-Olanda
English: À Av. da Siderurgia Nacional - 4745-457 S. Mamede do Coronado
Maltese: À Av. da Siderurgia Nacional4745-457 S.
English: Pharmacotherapeutic group: HMG-CoA reductase inhibitors, ATC code: C10A A04
Maltese: Kategorija farmakoterapewtika: inibituri ta' HMG-CoA reductase, Kodiċi ATC: C10A A04
English: Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 Boulogne France
Maltese: Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 Boulogne Franza
English: UCB PHARMA S.p.A Via Gadames, 57 20151 Milano Italy
Maltese: UCB PHARMA S.p.A Via Gadames, 57 20151 Milano L-Italja
English: National Road No. 1 (12th Km)
Maltese: National Road No. 1 (12th Km), Metamorphosis
English: Kasou 21, 1086 Nicosia, Cyprus
Maltese: Kasou 21, 1086 Nicosia Ċipru
English: Metamorphosis GR-144 51 Athens, Greece
Maltese: GR-144 51 Athens
English: Novartis Farmacéutica S.A. Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,
Maltese: Novartis Farmacéutica S.A. Gran Via de les Corts Catalanas, N° 764, 08013 Barcelona Spanja
English: Baseline TG ≥ 200 mg/dl
Maltese: Linja bażi tat-TG ≥ 200 mg/dl
English: - Rifampicin (an antibiotic).
Maltese: - Rifampiċin (antibjotiku).
English: Lescol was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Maltese: Lescol kien inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju ta' Karatteristiċi tal-Prodotti (SPC) magħmula misCMD(h), skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendata.
English: Novartis Norge AS, Postboks 237 Økern, 0510 Oslo, Norway
Maltese: In-Norveġja Novartis Norge AS Postboks 237 Økern 0510
English: The apparent volume of distribution (Vz/f) for the drug is 330 litres.
Maltese: Il-volum apparenti tad-distribuzzjoni (Vz/f) għall-mediċina huwa ta' 330 litru.
English: Homozygous familial hypercholesterolaemia
Maltese: Iperkolesterolemija familjari omozigote
English: Section 4.3 - Contra-indications
Maltese: Sezzjoni 4.3 - Kontra-indikazzjonijiet
English: ITALFARMACO S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
Maltese: Viale Fulvio Testi, 330 20126 Milano L-Italja
English: Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR,
Maltese: Frimley Business Park Frimley, Camberley Surrey GU16 7SR Ir-Renju Unit
English: Novartis Sverige AB Box 1150, 18311 Täby, Sweden
Maltese: Novartis Sverige AB Box 1150
English: Gesundheitsproducte GmbH Ruhlandstrasse 5, 83646 Bad Töltz,
Maltese: Ruhlandstrasse 5, 83646 Bad Töltz Il-Ġermanja
English: Slovak Republic Novartis, s.r.o.
Maltese: Is-Slovakkja Novartis, s.r.o.
English: Frimley Business Park Frimley, Camberley
Maltese: Frimley, Camberley
English: • Personal or familial history of hereditary muscular disorders.
Maltese: • Storja personali jew fil-familja ta' disturbi muskolari ereditarji.
English: The primary endpoint of MACE occurred in 21.4% of patients treated with fluvastatin vs 26.7% of patients treated with placebo (absolute risk difference: 5.2%; 95% CI: 1.1 to 9.3).
Maltese: L-endpoint primarju ta' MACE seħħ f'21.4% tal-pazjenti ikkurati bi fluvastatin kontra 26.7% tal-pazjenti ikkurati bi plaċebo (differenza ta' riskju assolut: 5.2%; 95% CI: 1.1 għal 9.3).
English: SANDOZ S.p.A Address: Largo Umberto Boccioni 1
Maltese: SANDOZ S.p.A Largo Umberto Boccioni 1 I-21040
English: United Kingdom Novartis Pharmaceuticals UK Ltd (Trading as Sandoz
Maltese: Ir-Renju Unit Novartis Pharmaceuticals UK Ltd (Trading as Sandoz Pharmaceuticals) Frimley Business Park
English: Follow your doctor's instructions carefully.
Maltese: Jaf ikollok bżonn ta' attenzjoni medika.
English: Lescol/Lescol XL is contraindicated:
Maltese: Lescol/Lescol XL huwa kontraindikat:
English: Novartis Finland Oy Metsänneidonkuja 10 FIN-02130 Espoo, Finland
Maltese: Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Il-Finlandja
English: 08029 Barcelona Spain
Maltese: 08029 Barcelona Spanja
English: Bulgaria, Estonia, Hungary, Slovenia
Maltese: Il-Bulgarija, L-Estonja, L-Ungerija, Slovenja
English: The incidence of MACE was 21.4% on fluvastatin and 26.7% on placebo.
Maltese: L-inċidenza ta' MACE kienet ta' 21.4% bi fluvastatin u 26.7% bil-plaċebo.
English: Glibenclamide (5 to 20 mg daily) increased the mean Cmax and AUC of fluvastatin by 44% and 51%, respectively.
Maltese: Il-glibenklamida (5 sa 20 mg kuljum) żiedet il-medja Cmax u AUC ta' fluvastatin b'44% u 51% rispettivament.
English: Fluvastatin "Novartis" MR 80 mgFilmtabletten
Maltese: Fluvastatin "Novartis" MR 80 mg - Filmtabletten
English: 2100 Kopenhagen Ø, Denmark
Maltese: København Ø Id-Danimarka
English: The Reference Member State was Germany (BfArM).
Maltese: L-Istat Membru ta' Referenza kien il-Ġermanja (BfArM).
English: Itraconazole and erythromycin
Maltese: L-itrakonazol u l-eritromiċin
English: Laboratório NormalProdutos Farmacêuticos, S.A. Rua do Centro empresarial, Edifício 8, Quinta da Beloura 2710-444 Sintra Portugal
Maltese: Rua do Centro empresarial, Edif. 8 Quinta da Beloura 2710-444
English: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Malta, Norway, Netherlands, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, United Kingdom
Maltese: L-Awstrija, Il-Belġju, Ċipru, Ir-Repubblika Ċeka, IdDanimarka, Il-Finlandja, Franza, Il-Ġreċja, L-Islanda, LIrlanda, L-Italja, Malta, In-Norveġja, L-Olanda, Il-Polonja, Il-Portugall, Ir-Rumanija, Is-Slovakkja, Spanja, L-Isvezja, Ir-Renju Unit
English: Fibrates and niacin
Maltese: Fibrati u nijaċin
English: Rhabdomyolysis, myositis, lupus erythematosus-like reactions
Maltese: Rabdomijolożi, mijositi, reazzjonijiet bħal lupus erythematosus
English: Based on pooled analyses of controlled clinical trials confirmed elevations of alanine aminotransferase or aspartate aminotranferase levels to more than 3 times the upper limit of normal occurred in 0.2% on Lescol capsules 20 mg/day, 1.5% to 1.8% on Lescol capsules 40 mg/day, 1.9% on Lescol XL tablets 80 mg/day and in 2.7% to 4.9% on twice daily Lescol capsules 40 mg.
Maltese: Skont firxa ta' analiżijiet miġburin flimkien meħudin minn provi kliniċi kkontrollati differenti ġie kkonfermat li kien hemm żidiet fil-livelli tal-alanina aminotransferasi jew tal-aspartat aminotransferasi ta' tliet darbiet aktar mill-ogħla limitu tan-normal f'0.2% tal-pazjenti li ngħataw kapsuli ta' 20 mg Lescol kuljum, f'bejn 1.5% u 1.8% tal-pazjenti li ngħataw kapsuli ta' 40 mg Lescol kuljum, f'1.9% tal-pazjenti li ngħataw pilloli ta' 80 mg Lescol XL kuljum u f'bejn 2.7% u 4.9% tal-pazjenti li ngħataw kapsuli ta' 40 mg Lescol darbtejn kuljum.
English: Also, the relative reduction in LDL-C is similar across different baseline levels of LDL-C.
Maltese: Barra minn hekk, it-tnaqqis relattiv f'LDL-C huwa simili tul il-livelli bażi differenti ta' LDL-C.
English: The risk ratios of cardiac death (RR 0.53) and cardiac death or nonfatal MI (RR 0.69) were also less than 1 but the study was not powered for these endpoints.
Maltese: Il-proporzjonijiet tar-riskju ta' mewta kardijaka (RR 0.53) u mewta kardijaka jew MI mhux fatali (RR 0.69) kienu wkoll inqas minn 1 iżda l-istudju ma kienx ippreparat għal dawn il-punti ta' tmiem.
English: Demark, Finland, Iceland, Norway, Sweden
Maltese: Id-Danimarka, Il-Finlandja, L-Islanda, In-Norveġja, LIsvezja
English: Overall Lescol was safe and well tolerated and the observed safety profile consistent with the known adverse event profile.
Maltese: Globalment, Lescol kien sigur u tollerat sewwa u l-profil ta' sigurtà osservat kien konsistenti malprofil ta' avveniment avvers magħruf.
English: Myalgia, muscle weakness, myopathy
Maltese: Mijalġija, indebboliment muskolari, mijopatija
English: Other skin reactions (e.g. eczema, dermatitis, bullous exanthema), face oedema, angioedema Musculoskeletal and connective tissue disorders Rare:
Maltese: Reazzjonijiet oħrajn tal-ġilda (eż. ekżema, dermatite, eżantema bulluża), edima fil-wiċċ, anġjodema Disturbi muskoluskeletrali u tat-tessuti konnettivi
English: In this randomised, double-blind, placebo-controlled trial fluvastatin (n=844), given as 80 mg daily over 4 years, significantly reduced the risk of the first MACE by 22% (p=0.013) as compared to placebo (n=833).
Maltese: F'din il-prova randomizzata, double-blind u kkontrollata bi plaċebo l-fluvastatin (n=844), mogħti f'doża ta' 80 mg kuljum għal 4 snin, naqqas b'mod sinifikanti r-riskju ta' MACE għall-ewwel darba bi 22% (p=0.013) meta mqabbel mal-plaċebo (n=833).
English: Skeletal muscle
Maltese: Il-muskoli skeletriċi
English: 40 mg Capsule
Maltese: 40 mg Kapsula
English: Bartók Béla út 43-47, 5th Floor, 1114 Budapest, Hungary
Maltese: L-Ungerija Novartis Hungária Kft. Pharma Bartók Béla út 43-47, 5th Floor 1114
English: Hungary, Ireland, Latvia, Lithuania, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, United Kingdom
Maltese: L-Estonja, Il-Bulgarija, Ċipru, Ir-Repubblika Ċeka, IlĠreċja, L-Ungerija, L-Irlanda, Il-Latvja, Il-Litwanja, Malta, L-Olanda, Il-Polonja, Il-Portugall, Ir-Rumanija, IsSlovakkja, Slovenja, Ir-Renju Unit