FrancophonIA/ELRC3.0 huggingface dataset:
English: Study in animals has shown effects on semen parameters, without a significant impact on reproductive performance in males and reduction on the percentage of live foetuses in treated females (see section
Maltese: Studju fl-annimali wera effetti fuq il-parametri tas-semen, mingħajr impatt sinifikanti fuq ilprestazzjoni riproduttiva fl-irġiel u tnaqqis fuq il-perċentwal ta' feti ħajjin fin-nisa kkurati (ara sezzjoni 5.3).
English: General physical condition abnormal Electrocardiogram repolarisation abnormality Electrocardiogram T wave inversion
Maltese: Kundizzjoni fiżika ġenerali mhux normali Anormalità firripolarizzazzjoni talelettrokardjogramma Inverżjoni tal-mewġa T talelettrokardjogramma
English: High density polyethylene (HDPE) bottle with a tamper evident, child-resistant, polypropylene screw cap fitted with desiccant (silica gel).
Maltese: Flixkun tal-polyethylene ta' densità għolja (HDPE - high density polyethylene) b'tapp b'kamin talpolypropylene li jagħmel kull tbagħbis fuqu evidenti u li huwa reżistenti għat-tfal b'dessikant (silica gel).
English: Pitolisant blocked hERG channel with an IC50 exceeding therapeutic concentrations and induced a slight QTc prolongation in dogs.
Maltese: Pitolisant imblokka l-kanal hERG b'IC50 li jaqbeż il-konċentrazzjonijiet terapewtiċi u wassal għal prolongament żgħir tal-QTc fil-klieb.
English: Figure 2: Changes in weekly cataplexy episodes (geometric mean) from Baseline to week 7 in Harmony CTP study
Maltese: Figura 2: Tibdil fl-episodji ta' kataplessija fil-ġimgħa (medja ġeometrika) mil-Linja bażi għal ġimgħa 7 fl-istudju Harmony CTP
English: Wakix 4.5 mg tablet Each tablet contains 5 mg of pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant
Maltese: Wakix 4.5 mg pillola miksija b'rita Kull pillola fiha 5 mg ta' pitolisant hydrochloride, ekwivalenti għal 4.45 mg ta' pitolisant.
English: Caution should be taken for patients with severe epilepsy.
Maltese: Għandu jkun hemm attenzjoni għal pazjenti b'epilessija severa.
English: Erythema Pruritus Rash Hyperhidrosis Sweating
Maltese: Dardir Rimettar Dispepsija
English: With oral contraceptives, the combination with pitolisant should be avoided and a further reliable contraceptive method used.
Maltese: Bil-kontraċettivi orali, għandha tiġi evitata kombinazzjoni ma' pitolisant u għandu jintuża metodu ta' kontraċezzjoni ieħor affidabbli.
English: Teratogenic effect of pitolisant was observed at maternally toxic doses (teratogenicity safety margins < 1 in rats and in rabbits).
Maltese: Effett teratoġeniku ta' pitolisant kien osservat f'dożi tossiċi għall-omm (livelli ta 'sigurtà teratoġeniċità <1 fil-firien u fil-fniek).
English: Wakix 18 mg film-coated tablet
Maltese: Wakix 18 mg pillola miksija b'rita
English: Symptoms of Wakix overdose may include headache, insomnia, irritability, nausea and abdominal pain.
Maltese: Sintomi ta' doża eċċessiva ta' Wakix jistgħu jinkludu uġigħ ta' ras, insomnija, irritabilità, dardir u uġigħ addominali.
English: The exposure to pitolisant in healthy volunteers was assessed in studies involving more than 200 subjects that received doses of pitolisant in single administration up to 216 mg and for a duration up to 28 days.
Maltese: L-esponiment għal pitolisant f'voluntiera b'saħħithom ġie vvalutat fi studji li jinvolvu aktar minn 200 individwu li rċevew dożi ta' pitolisant f'għoti waħdieni ta' mhux aktar minn 216 mg u għal perjodu ta' żmien ta' mhux aktar minn 28 jum.
English: Rebound effect
Maltese: Effett rebound
English: Maintenance of efficacy
Maltese: Manteniment tal-effikaċja
English: In rats, transient reversible convulsive episodes occurred at Tmax , that may be attributable to a metabolite abundant in this species but not in humans.
Maltese: Fil-firien, seħħew episodji konvulsivi riversibbli temporanji f'Tmax, li jistgħu jkunu attribwibbli għal metabolit abbundanti f'din l-ispeċi iżda mhux fil-bnedmin.
English: The major non-conjugated metabolites are hydroxylated derivatives in several positions and cleaved forms of pitolisant leading to inactive major carboxylic acid metabolite found in urine and serum.
Maltese: Il-metaboliti mhux konjugati maġġuri huma d-derivattivi hydroxylated f'bosta pożizzjonijiet u forom maqsumin ta' pitolisant li jwassal għall-metabolit tal-carboxylic acid maġġuri inattiv li jinsab fl-awrina u fis-serum.
English: The MWT value in the pitolisant group was 80% higher than in the placebo group.
Maltese: Il-valur ta' MWT fil-grupp ta' pitolisant kien 80% ogħla milli fil-grupp ta' plaċebo.
English: The metabolisation of pitolisant in humans is fully characterized.
Maltese: Il-metabolizzazzjoni ta' pitolisant fil-bnedmin mhijiex kompletament karatterizzata.
English: OUTER CARTON WITH BLUE BOX
Maltese: L-KAXXA BLU
English: Based on in vitro data, pitolisant and its main metabolites may induce CYP3A4 and CYP2B6 at therapeutic concentrations and by extrapolation, CYP2C, UGTs and P-gp.
Maltese: Abbażi ta' dejta in vitro, pitolisant u l-metaboliti ewlenin tiegħu jistgħu jinduċu CYP3A4 u CYP2B6 f'konċentrazzjonijiet terapewtiċi u permezz ta' estrapolazzjoni, CYP2C, UGTs u P-gp. Mhija disponibbli l-ebda dejta klinika dwar il-kobor ta' din l-interazzjoni.
English: Decreased appetite Increased appetite Fluid retention
Maltese: - Telf ta' aptit, żieda fl-aptit
English: Gastrooesophageal reflux disease Gastritis Gastrointestinal pain Hyperacidity Paraesthesia oral Stomach discomfort
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: stomach pain and discomfort, gastritis, excessive acidity of the gastrointestinal tract - Itching, skin condition of the face where the nose and cheeks are unusually red, excessive sweating - Joint pain, back pain, muscle rigidity, muscle weakness, pain of the muscle and the bones, pain in the toes and in the fingers - Abnormal urination - Irregular uterine bleeding - Loss of strength or extreme tiredness, chest pain, malaise, oedema - Weight increase, weight decrease, abnormal reading (ECG) of the heart, abnormal blood values related to the function of the liver.
Maltese: - Imġiba mhux normali, stat ta' konfużjoni, burdata depressa, eċċitabbiltà, sentimenti ta' skonfort emozzjonali u mentali, sensazzjoni li tara jew tisma' affarijiet li mhumiex tabilħaqq hemm meta torqod - Telf mis-sensi, uġigħ ta' ras b'tensjoni, problemi ta' memorja, irqad ta' kwalità ħażina - Skumdità fl-addome, diffikultà jew uġigħ biex tibla', gass, infjammazzjoni tas-sistema diġestiva - Infezzjoni tal-ġilda, sensittività għolja b'mod anormali għax-xemx - Uġigħ fl-għonq, uġigħ fis-sider - Abort spontanju - Uġigħ, għaraq bil-lejl, sens ta' oppressjoni - Livell għoli fid-demm tal-enzima creatinine phosphokinase, kundizzjoni fiżika ġenerali anormali, modifika tar-reġistrazzjoni elettrika tal-qalb (ECG)
English: To date, there are limited amount of data from an open label study on long term efficacy of Wakix in this indication.
Maltese: Sal-lum, hemm ammont limitat ta' dejta minn studju open label fuq l-effikaċja fit-tul ta' Wakix f'din l-indikazzjoni.
English: Electrocardiogram QT prolonged Heart rate increased Gammaglutamyltransferase increased
Maltese: Prodotti mediċinali li pitolisant jista' jaffettwa l-metaboliżmu tagħhom
English: Results from cataplexy rate at 18 mg once a day were not consistent with those of the first pivotal study (36 mg once a day).
Maltese: Ir-riżultati minn rata ta' kataplessija ta' 18 mg darba kuljum ma kinux konsistenti ma' dawk tal-ewwel studju pivotali (36 mg darba kuljum).
English: Renal impairment In patients with renal impairment, the maximum daily dose should be 18 mg.
Maltese: Indeboliment tal-kliewi F'pazjenti b'indeboliment tal-kliewi, id-doża massima ta' kuljum għandha tkun 18 mg.
English: Coating
Maltese: Tinnite
English: At the highest doses, no histopathological changes were recorded in monkeys and rats presented some limited histopathological changes in some organs (liver, duodenum, thymus, adrenal gland and lung).
Maltese: Fl-ogħla dożi, l-ebda tibdil istopatoloġiku ma ġie rreġistrat fix-xadini u l-firien ippreżentaw xi tibdiliet istopatoloġiċi limitati f'xi organi (fwied, duwodenu, timu, glandola adrenali u pulmun).
English: Narcolepsy (with or without cataplexy) is a chronic condition.
Maltese: Narkolessija (bi jew mingħajr kataplessija) hija kundizzjoni kronika.
English: Elderly
Maltese: Kisja
English: Pitolisant is a potent, orally active histamine H3-receptor antagonist/inverse agonist which, via its blockade of histamine auto-receptors enhances the activity of brain histaminergic neurons, a major arousal system with widespread projections to the whole brain.
Maltese: Pitolisant huwa antagonista/agonista invers tar-riċettur tal-istamini H3 attiv oralment, qawwi li, permezz tal-imblokk ta' awto-riċetturi tal-istamini jtejjeb l-attività tan-newroni istaminerġiċi tal-moħħ, sistema ta' qawmien maġġuri bi projezzjonijiet mifruxin għall-moħħ kollu.
English: Non-interventional post-authorisation safety study (PASS): A multi-center, observational post-authorization safety study to document the drug utilisation of Wakix and to collect information on the safety of Wakix when used in routine medical practice
Maltese: Studju dwar is-sigurtà multiċentriku, osservazzjonali ta' wara lawtorizzazzjoni biex jiddokumenta l-użu talmediċina ta' Wakix u biex jiġbor informazzjoni dwar is-sigurtà ta' Wakix meta użat fi prattika mediċinali ta' rutina.
English: In patients with mild hepatic impairment (Child-Pugh A), there was no significant changes in pharmacokinetics compared with normal healthy volunteers.
Maltese: F'pazjenti b'indeboliment tal-fwied ħafif (Child-Pugh A), ma kien hemm l-ebda tibdil sinifikanti filfarmakokinetiċi meta mqabbel ma' voluntiera normali b'saħħithom.
English: 30 film-coated tablets.
Maltese: 30 pillola miksija b'rita.
English: Wakix 4.5 mg film-coated tablets Wakix 18 mg film-coated tablets
Maltese: Wakix 4.5 mg pillola miksija b'rita
English: In clinical trials, no specific cardiac safety signal was identified at therapeutic doses of pitolisant.
Maltese: Fi provi kliniċi, ma ġie identifikat l-ebda sinjal tas-sigurtà kardijaka speċifiku fid-dożi terapewtiċi ta' pitolisant.
English: Animal study has shown excretion of pitolisant/metabolites in milk.
Maltese: Studju fl-annimali wera l-eliminazzjoni ta' pitolisant/metaboliti fil-ħalib.
English: Therefore, an alternative method of effective contraception should be used if the woman patient is using hormonal contraceptives (see sections 4.5 and 4.6).
Maltese: Għalhekk, metodu alternattiv ta' kontraċezzjoni effikaċi għandu jintuża jekk il-pazjenta mara tkun qiegħda tuża kontraċettivi ormonali (ara sezzjonijiet 4.5 u 4.6).
English: Page 2/2
Maltese: Pågna 2/2
English: The full EPAR for Leflunomide ratiopharm can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Leflunomide ratiopharm jinsab fuq il-websajt tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as white round tablets (10 and 20 mg).
Maltese: Tiġi f'pilloli tondi bojod (10 mg u 20 mg).
English: The applicant presented data on experimental models from the scientific literature.
Maltese: L-applikant ippreżenta dejta fuq mudelli sperimentali mil-letteratura xjentifika.
English: Leflunomide ratiopharm is a ‘generic medicine'.
Maltese: Leflunomide ratiopharm hija ‘mediċina ġenerika'.
English: The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Maltese: Id-doża ta' manteniment irrakkomandata hija 10 mg sa 20 mg darba kuljum f'pazjenti li jbatu bl-artrite rewmatojde, u 20 mg darba kuljum f'pazjenti li jbatu bl-artrite psorjatika.
English: Leflunomide ratiopharm is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Maltese: Leflunomide ratiopharm jintuża biex jittratta adulti bl-artrite rewmatojde attiva (marda tas-sistema immunitarja li tikkawża infjammazzjoni tal-ġogi) jew l-artrite attiva psorjatika (marda li tikkawża rqajja ħomor li jitqaxxru fuq il-ġilda u infjammazzjoni tal-ġilda).
English: The active substance in Leflunomide ratiopharm, leflunomide, is an immunosuppressant.
Maltese: Is-sustanza attiva f'Leflunomide ratiopharm, hija immunosuppressur.
English: This is a summary of the European public assessment report (EPAR) for Leflunomide ratiopharm.
Maltese: Dan huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropea (EPAR) għal Leflunomide ratiopharm.
English: The CHMP concluded that, in accordance with EU requirements, Leflunomide ratiopharm has been shown to have comparable quality and to be bioequivalent to Arava.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, kien intwera li Leflunomide ratiopharm għandu kwalità komparabbli ma' Arava u li huwa bijoekwivalenti għalih.
English: Leflunomide ratiopharm is a medicine that contains the active substance leflunomide.
Maltese: Leflunomide ratiopharm huwa mediċina li fiha s-sustanza attiva leflunomide.
English: Other information about Leflunomide ratiopharm
Maltese: Aktar informazzjoni dwar Leflunomide ratiopharm
English: The European Commission granted a marketing authorisation valid throughout the European Union for Leflunomide ratiopharm on 29 November 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unojoni Ewropea kollha għal Leflunomide ratiopharm lil ratiopharm GmbH fid-29 ta' Novembru 2010.
English: Because Leflunomide ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Maltese: Ġaladarba Leflunomide ratiopharm huwa mediċina ġenerika u bijoekwivalenti għall-mediċini ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċini ta' referenza.
English: Leflunomide ratiopharm treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Maltese: It-trattament b'Leflunomide ratiopharm jibda b'‘doża ta' tagħbija' ta' 100 mg darba kuljum tul tlett ijiem, u wara għandha tittieħed doża ta' manteniment.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Iż-żewġ mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli ta' sustanza attiva fil-ġisem.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għall-aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument li jwieġeb mistoqsijiet komuni hawnhekk.
English: Because Leflunomide ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Maltese: Billi Leflunomide ratiopharm huwa mediċina ġenerika, l-istudji fil-pazjenti ġew limitati għal testitjiet li jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza Arava.
English: What is Leflunomide ratiopharm?
Maltese: X'inhu Leflunomide ratiopharm?
English: This means that Leflunomide ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Maltese: Dan ifisser li Leflunomide ratiopharm jixbah lil ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li tissejjaħ Arava.
English: How has Leflunomide ratiopharm been studied?
Maltese: Kif ġie studjat Leflunomide ratiopharm?
English: It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Maltese: Dan inaqqas l-infjammazzjoni billi jnaqqas il-produzzjoni ta' ċelloli immuni msejħin ‘limfoċiti', li jikkaġunaw l-infjammazzjoni.
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide ratiopharm, and regularly during treatment.
Maltese: Inqas ma jkun hemm limfoċiti inqas ikun hemm infjammazzjoni, u dan jgħin biex jiġu kkontrollati s-sintomi tal-artrite.
English: Why has Leflunomide ratiopharm been approved?
Maltese: Għaliex ġie approvat Leflunomide ratiopharm?
English: tadalafil
Maltese: Adcirca tadalafil
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom necessary depending on the patient's response.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The full EPAR for Adcirca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Adcirca is a medicine that contains the active substance tadalafil.
Maltese: Adcirca huwa mediċina li fiha s-sustanza attiva tadalafil.
English: The ‘class' reflects the seriousness of the disease: ‘class II' involves slight limitation of physical activity and ‘class III' involves marked limitation of physical activity.
Maltese: Il-'klassi' tirrifletti l-gravità tal-marda: “klassi II” tinvolvi limitazzjoni żgħira tal-attività fiżika u “klassi III” tinvolvi limitazzjoni notevoli tal-attività fiżika.
English: Previously known as Tadalafil Lilly.
Maltese: Preċedentement magħruf bħala Tadalafil Lilly.
English: The most common side effects with Adcirca (seen in more than 1 patient in 10) are headache, flushing (reddening of the skin), nasopharyngitis (inflammation of the nose and throat) including a blocked or runny nose and blocked sinuses, nausea (feeling sick), dyspepsia (heartburn) including stomach ache, myalgia (muscle pain), back pain and pain in the extremities (arms, hands, legs and feet).
Maltese: L-effetti sekondarji l-aktar komuni b'Adcirca (li dehru f'aktar minn pazjent wieħed minn għaxra) huma l-uġigħ ta' ras, fwawar (ħmura fil-ġilda), nasofarinġite (infjammazzjoni tal-imnieħer u l-griżmejn) inkluż imnieħer imblukkat jew flissjoni u sinus imblukkat, nawżja (dardir), dispepsja (ħruq ta' stonku) inkluż uġigħ fl-istonku, mijalġja (uġigħ fil-muskoli), uġigħ fid-dahar u uġigħ fl-estremitajiet (dirgħajn, idejn, riġlejn u saqajn).
English: This is a summary of the European public assessment report (EPAR) for Adcirca.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Adcirca.
English: Four doses of Adcirca (2.5, 10, 20 and 40 mg once a day) have been compared with placebo (a dummy treatment) in one main study involving 406 patients with PAH, most of whom had class II or class III disease that was of unknown cause or caused by collagen vascular disease.
Maltese: Ġew imqabbla erba' dożi ta' Adcirca (2.5, 10, 20 u 40 mg darba kuljum) ma' plaċebo (kura finta) fi studju ewlieni li involva 406 pazjent li jbatu bil-PAH, li l-biċċa l-kbira tagħhom kellhom il-marda talklassi II jew tal-klassi III li l-kawża tagħha ma kinitx magħrufa jew li kienet ikkawżata minn mard vaskulari tal-kollaġene.
English: The active substance in Adcirca, tadalafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Maltese: Is-sustanza attiva f'Adcirca, it-tadalafil, tappartjeni lil grupp ta' mediċini msejħa “inibituri tal-fosfodjesterażi ta' tip 5 (PDE5)”, jiġifieri li jfisser li jimblokka l-enzima PDE5.
English: The European Commission granted a marketing authorisation valid throughout the EU for Tadalafil Lilly on 1 October 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Tadalafil Lilly fl-1 ta' Ottubru 2008.
English: How does Adcirca work?
Maltese: Għal xiex jintuża Adcirca?
English: What is the risk associated with Adcirca?
Maltese: X'inhu r-riskju assoċjat ma' Adcirca?
English: Adcirca must not be taken with nitrates (a group of medicines used to treat angina) or medicines of the class ‘guanylate cyclase stimulators' such as riociguat (another medicine to treat pulmonary hypertension).
Maltese: Adcirca m'għandux jittieħed man-nitrati (grupp ta' mediċini użati għall-kura tal-anġina) jew mediċini tal-klassi 'guanylate cyclase stimulators' bħal riociguat (mediċina oħra li tikkura l-ipertensjoni pulmonari).
English: A risk management plan has been developed to ensure that Adcirca is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Adcirca jintuża bl-aktar mod sigur possibbli.
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Maltese: Il-PAH huwa pressjoni taddemm għolja b'mod anormali fl-arterji tal-pulmuni.
English: Adcirca is used in patients with class II or III disease.
Maltese: Adcirca jintuża f'pazjenti bil-marda tal-klassi II jew III.
English: This authorisation was based on the authorisation granted to Cialis in 2002 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija lil Cialis fl-2002 (‘kunsens infurmat').
English: After 16 weeks, this distance had increased by 26 metres more in the patients taking 40 mg Adcirca than in the patients taking placebo.
Maltese: Wara 16-il ġimgħa, din id-distanza żdiedet b'26 metru aktar fil-pazjenti li qed jieħdu Adcirca ta' 40 mg milli fil-pazjenti li qed jieħdu plaċebo.
English: Adcirca is used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Maltese: Adcirca jintuża għall-kura tal-adulti li jbatu minn ipertensjoni arterjali fil-pulmun (PAH) sabiex itejjeb ilkapaċità tal-eżerċizzju fiżiku (l-abbiltà li bniedem jagħmel attività fiżika).
English: How has Adcirca been studied?
Maltese: Kif ġie studjat Adcirca?
English: PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Maltese: Il-PAH hija marda ta' indeboliment meta jkun hemm konstrizzjoni (tidjieq) gravi fl-arterji u fil-vini talpulmuni.
English: This enzyme is found in the blood vessels of the lungs.
Maltese: Din l-enzima tinstab fil-vini u fl-arterji tal-pulmun.
English: For the full list of all side effects and restrictions with Adcirca, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Adcirca, ara l-fuljett ta' tagħrif.
English: When the enzyme is blocked, a substance called ‘cyclic guanosine monophosphate' (cGMP) cannot be broken down and remains in the vessels where it causes the relaxation and widening of the blood vessels.
Maltese: Meta l-enzima tiġi mblukkata, sustanza msejħa “gwanożina monofosfat ċikliku” (cyclic guanine monophosphate - cGMP) ma tistax titkisser u tibqa' fl-arterji u fil-vini fejn tikkawża r-rilassament u t-twessigħ fil-vini u l-arterji.
English: Why has Adcirca been approved?
Maltese: Għaliex ġie approvat Adcirca?
English: Other information about Adcirca
Maltese: X'inhu Adcirca?
English: The CHMP decided that Adcirca's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Adcirca huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Adcirca is not recommended for patients with severe kidney or liver problems.
Maltese: Adcirca mhux rakkomandat għal pazjenti bi problemi serji fil-kliewi jew fil-fwied.
English: Before treatment, the patients could walk an average of 343 metres in six minutes.
Maltese: Qabel il-kura, ilpazjenti setgħu jimxu medja ta' 343 metru f'sitt minuti.
English: Vojvodići 25, Novaki Sveta Nedelja
Maltese: Vojvodići 25, Novaki Sveta
English: Denmark Eli Lilly Danmark A/S Lyskær 3E, 2.tv.
Maltese: Danimarka Eli Lilly Danmark A/S Lyskær 3E, 2.tv.
English: 169 27 Solna
Maltese: 169 27 Solna Sweden
English: Sweden Eli Lilly Sweden AB Box 721
Maltese: Eli Lilly Sweden AB Box 721
English: 203 11 Malmö
Maltese: 203 11 Malmö Sweden
English: Ringener Str. 45
Maltese: KG Ringener Str. 45
English: Sweden Ferring Läkemedel AB Box 4041
Maltese: Ferring Läkemedel AB Box 4041