FrancophonIA/ELRC3.0 huggingface dataset:
English: In humans, the combination of ACE inhibitors and NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) can lead to reduced anti-hypertensive efficacy or impaired kidney function.
Maltese: Fil-bnedmin, il-kombinazzjoni ta' inibituri ACE ma' NSAIDs (Mediċini Anti-Infjammatorji Mhux Sterojdali) tista' twassal għal effikaċja mnaqqsa kontra l-pressjoni għolja jew għal funzjoni tal-kliewi indebolita.
English: Your veterinary surgeon may recommend to monitor plasma potassium concentrations when using “product name” (to be completed nationally) in combination with a potassium-sparing diuretic because of the risk of hyperkalaemia (high blood potassium).
Maltese: Il-kirurgu veterinarju tiegħek jista' jirrakkomanda li jimmonitorja lkonċentrazzjonijiet tal-potassju tal-plasma meta jintuża “isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) f'kombinazzjoni ma' dijuretiku li jibża' għall-potassju minħabba riskju ta' iperkalamija (livell ta' potassju għoli fid-demm).
English: “Product name” (to be completed nationally) should be administered orally at a minimum dose of 0.25 mg (range 0.25-0.5) benazepril hydrochloride/kg body weight once daily, according to the following table:
Maltese: “Isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) għandu jingħata oralment f'doża minima ta' 0.25 mg (firxa 0.25-0.5) benazepril hydrochloride/kg piż tal-ġisem darba kuljum, skont it-tabella li ġejja:
English: Dogs: Treatment of heart failure
Maltese: Kelb: Kura ta' indeboliment talqalb
English: Dogs: “Product name” (to be completed nationally) should be administered orally at a minimum dose of 0.25 mg (range 0.25-0.5) benazepril hydrochloride/kg body weight once daily, according to the following table:
Maltese: Klieb: “Isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) għandu jingħata oralment f'doża minima ta' 0.25 mg (firxa 0.25-0.5) benazepril hydrochloride/kg piż tal-ġisem darba kuljum, skont it-tabella li ġejja:
English: Dogs: For the symptomatic, adjunctive therapy in the treatment with the diuretic furosemide of heart failure caused by mitral failure or congestive cardiomyopathy.
Maltese: Klieb: Għall-kura aġġuntiva, sintomatika fil-kura bid-dijuretiku furosemide ta' kollass tal-qalb ikkawżat minn kollass mitrali jew kardjomijopatija konġestiva.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains 2.5 mg benazepril hydrochloride.
Maltese: U INGREDJENT(I) OĦRA Kull pillola fiha 2.5 mg benazepril hydrochloride.
English: Cardiac failure in dogs, chronic renal insufficiency in cats
Maltese: Klieb Kollass kardijaku fil-klieb, insuffiċjenza renali kronika filqtates
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each film-coated tablet contains 20 mg benazepril hydrochloride
Maltese: U INGREDJENT(I) OĦRA Kull pillola miksijn b'rita fiha 20 mg benazepril hydrochloride.
English: There is no significant difference in the pharmacokinetics of benazeprilat when benazepril hydrochloride is administered to fed or fasted dogs.
Maltese: Ma hemm ebda differenza sinifikanti fil-farmakokinetiċi ta' benazeprilat meta benazepril hydrochloride jingħata lil klieb mitmugħin jew sajmin.
English: For dogs over 20 kg Treatment of heart failure
Maltese: Klieb Għal klieb ta' aktar minn 20 kg Kura ta' indeboliment tal-qalb
English: “Product name” (to be completed nationally) reduced erythrocyte counts in normal dogs when dosed at 150 mg/kg body weight once daily for 12 months, but this effect was not observed at the recommended dose during clinical trials in dogs.
Maltese: “Isem tal-prodott" (li għandu jimtela fuq livell nazzjonali) naqqas l-għedud ta' ertroċiti fi klieb normali meta ddożati f'150 mg/kg piż tal-ġisem darba kuljum għal 12-il xahar, iżda dan l-effett ma ġiex osservat fid-doża rakkomandata matul provi kliniċi fil-klieb.
English: Reduction of proteinuria associated with chronic kidney disease.
Maltese: Kura ta' insuffiċjenza renali kronika.
English: • Nefazodone an antidepressant.
Maltese: • Nefazodone antidepressant.
English: SN Lot:
Maltese: SN Lott:
English: INFORMATION IN BRAILLE Priligy 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Priligy 30 mg
English: • Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, black iron oxide (E172), yellow iron oxide (E172).
Maltese: • Kisja tar-rita: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron oxide iswed (E172), iron oxide isfar (E172).
English: PVC-PE-PVDC Blisters in Aluminium Foil
Maltese: Folji tal-PVC-PE-PVDC ġo Fojl tal-Aluminju
English: • Medicines for depression called ‘monoamine oxidase inhibitors' (MAOIs)
Maltese: • Medicines għad-depressjoni msejħa ‘impdeituri ta' monoamine oxidase ' (MAOIs)
English: • Feeling depressed, nervous or indifferent
Maltese: • Tħossok depressat, nervuż jew indifferenti
English: • Lithium a medicine for bipolar disorder
Maltese: • Lithium mediċina għad-disturb bipolari
English: • Certain medicines for fungal infection, including ketoconazole and itraconazole
Maltese: • Ċerti mediċini għal infezzjoni bil-moffa, inkluż ketoconazole u itraconazole
English: Avoid alcohol when taking Priligy.
Maltese: Evita li tixrob l-alkoħol meta tieħu Priligy.
English: • Certain medicines for HIV, including ritonavir, saquinavir, nelfinavir and atazanavir
Maltese: • Ċerti mediċini għall-HIV, inkluż ritonavir, saquinavir, nelfinavir u atazanavir
English: (see section “Taking other medicines”) o Certain medicines for fungal infection, including ketoconazole and itraconazole (see section “Taking other medicines”) o Certain medicines for HIV, including ritonavir, saquinavir, nelfinavir and atazanavir (see section “Taking other medicines”) o Certain antibiotics for treating infection, including telithromycin (see section “Taking other medicines”) o Nefazodone an antidepressant (see section “Taking other medicines”)
Maltese: Jekk m'intix ċert dwar x'se tagħmel, kellem lit-tabib jew lill-ispiżjar tiegħek qabel tieħu Priligy.(ara s-sezzjoni “Meta tieħu mediċini oħra”) o Ċerti mediċini għal infezzjoni bil-moffa, inkluż ketoconazole u itraconazole (ara s-sezzjoni “Meta tieħu mediċini oħra”) o Ċerti mediċini għall-HIV, inkluż ritonavir, saquinavir, nelfinavir u atazanavir (ara s-sezzjoni “Meta tieħu mediċini oħra”) o Ċerti antibijotiċi biex jikkuraw infezzjoni, inkluż telithromycin (ara s-sezzjoni “Meta tieħu mediċini oħra”) o Nefazodone antidepressant (ara s-sezzjoni “Meta tieħu mediċini oħra”)
English: • Avoid alcohol when taking Priligy.
Maltese: • Evita l-alkoħol meta tieħu Priligy.
English: Take Priligy 1 to 3 hours before sexual activity.
Maltese: Ħu Priligy minn 1 sa 3 sigħat qabel attività sesswali.
English: • Non steroidal anti inflammatory medicines such as ibuprofen or acetylsalicyclic acid
Maltese: • Mediċini antiinfjammatorji mhux sterojdi bħal ibuprofen jew acetylsalicyclic acid
English: • Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Maltese: • Qalba tal-pillola: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium,
English: Priligy contains lactose (a type of sugar).
Maltese: Priligy fih il-lactose (tip ta' zokkor).
English: The active substance is dapoxetine.
Maltese: Priligy fih is sustanza attiva msejħa ‘dapoxetine'.
English: • You are taking: o Medicines for depression called ‘monoamine oxidase inhibitors' (MAOIs) o Thioridazine used for schizophrenia o Other medicines for depression o Lithium a medicine for bipolar disorder o Linezolid an antibiotic used to treat infections o Tryptophan a medicine to help you sleep o St John's wort an herbal medicine o Tramadol used to treat serious pain o Medicines used to treat migraines.
Maltese: • Inti qed tieħu: o Mediċini għad-depressjoni msejħa ‘impedituri ta' monoamine oxidase' (MAOIs) o Thioridazine li jintuża għall-iskizofrenija o Mediċini oħra għad-depressjoni o Lithium mediċina għad-disturb bipolari o Linezolid antibijotiku li jintuża biex jikkura infezzjonijiet o Tryptophan mediċina biex tgħinek torqod o St John's wort mediċina magħmula mill-ħxejjex o Tramadol jintuża biex jikkura uġigħ serju o Mediċini użati għall-kura tal-emigranji.
English: • You use recreational drugs such as ecstasy, LSD, narcotics or benzodiazepines
Maltese: • Inti tuża drogi ta' rikreazzjoni bħal ecstasy, LSD, narkotiċi jew benzodiazepines
English: • St John's wort an herbal medicine
Maltese: • St John's wort mediċina magħmula mill-ħxejjex
English: The tablets are provided in compliance multi-fold blister packs containing 1, 2, 3 and 6 film coated tablets.
Maltese: Il-pilloli huma pprovduti f'konformità ma' pakketti ta' folji multi-fold li fihom 1, 2, 3 u 6 pilloli miksijin b'rita.
English: Each tablet contains 30 mg or 60 mg dapoxetine as a hydrochloride salt.
Maltese: Kull pillola fiha 30 mg jew 60 mg ta' dapoxetine bħala hydrochloride salt.
English: Rare side effects (affects 1 to 10 users in 10,000):
Maltese: Effetti sekondarji rari (jaffettwaw minn persuna waħda sa 10 persuni minn kull 10,000):
English: The medicinal product is provided in compliance multi-fold packages of 3 and 6 film-coated tablets.
Maltese: Il-prodott mediċinali huwa pprovdut f'pakketti multi-fold ta'konformità ta' 3 u 6 pilloli miksijin b'rita.
English: Film-coated tablets 1 tablet
Maltese: Pilloli miksijin b'rita pillola 1
English: Priligy 30 mg film-coated tablets Priligy 60 mg film-coated tablets dapoxetine
Maltese: Priligy 30 mg pilloli miksijin b'rita Priligy 60 mg pilloli miksijin b'rita dapoxetine
English: This belongs to a group of medicines called ‘selective serotonin reuptake inhibitors' (SSRIs).
Maltese: Din tagħmel parti minn grupp ta' mediċini msejħa ‘impedituri selettivi tal-assorbiment mill-ġdid tas-serotonin' (SSRIs).
English: • Only take the medicine 1 to 3 hours before sexual activity is anticipated.
Maltese: • Ħu l-mediċina biss minn 1 sa 3 sigħat qabel ma tistenna li se jkun hemm attività sesswali.
English: LABELLING
Maltese: TIKKETTA
English: • Priligy 60 mg filmcoated tablets are grey, round, convex and marked “60” inside a triangle on one side.
Maltese: • Il-pilloli miksijin b'rita Priligy 60 mg huma griżi, tondi, konvessi u mmarkati “60” ġo trijanglu fuq naħa waħda tal-pillola.
English: • Blocked nose (nasal congestion)
Maltese: • Imnieħer imblukkat (konġestjoni fl-imnieħer)
English: Priligy may also be known as a ‘urological' medicine.
Maltese: Priligy jista' jkun magħruf ukoll bħala mediċina ‘uroloġika'.
English: • Thioridazine used for schizophrenia
Maltese: • Thioridazine li jintuża għall-iskizofrenija
English: In these compliance multi-fold packages, the blisters are glued onto the carton.
Maltese: F'dawn il-pakketti multi-fold ta' konformità, il-folji huma mwaħħlin bil-kolla mal-kaxxa.
English: Priligy should not be taken by women.
Maltese: Oqgħod attent ħafna bi Priligy
English: • Priligy 30 mg filmcoated tablets are light grey, round, convex and marked “30” inside a triangle on one side.
Maltese: • Il-pilloli miksijin b'rita Priligy 30 mg huma griżi ċari, tondi, konvessi u mmarkati “30” ġo trijanglu fuq naħa waħda tal-pillola.
English: • Teeth grinding.
Maltese: • Ħalq xott.
English: • The usual dose is 30 mg.
Maltese: • Id-doża tas-soltu hija 30 mg.
English: Do not take Priligy if:
Maltese: Biex tnaqqas ilprobabbiltà li dan jiġri:
English: Do not take Priligy more than once every 24 hours.
Maltese: Tiħux Priligy aktar minn darba kull 24 siegħa.
English: • Certain other antibiotics for treating infection, such as erythromycin and clarithromycin
Maltese: • Ċerti antibijotiċi oħra biex jikkuraw infezzjoni, bħal erythromycin u clarithromycin
English: • Certain antibiotics for treating infection, including telithromycin
Maltese: • Ċerti antibijotiċi biex jikkuraw infezzjoni, inkluż telithromycin
English: • You have ever had a mental health problem such as depression, mania (symptoms include feeling over excited, irritable or not being able to think clearly), bipolar disorder (symptoms include serious mood swings between mania and depression) or schizophrenia (a psychiatric disease)
Maltese: • Inti qatt kellek problemi ta' saħħa mentali bħal ma huma depressjoni, manija (sintomi jinkludu tħossok eċitat iż-żejjed, irritabbli jew ma tkunx tista' taħseb b'mod ċar), disturb bipolari (sintomi jinkludu tibdiliet serji fil-burdata minn manija għal depressjoni ) jew skizofrenija (marda psikjatrika)
English: To help lower the chance of this happening:
Maltese: Tkomplix tieħu Priligy u ara tabib minnufih jekk:
English: • Certain medicines used to treat erectile dysfunction, such as sildenafil, tadalafil or vardenafil,
Maltese: • Ċerti mediċini użati biex jikkuraw disfunzjoni erettili, bħal sildenafil, tadalafil jew vardenafil,
English: • You have not been diagnosed with premature ejaculation
Maltese: • Inti ma ġejtx dijanjostikat b'eġakulazzjoni prematura
English: • You are allergic (hypersensitive) to dapoxetine or any of the other ingredients of Priligy (listed in section 6)
Maltese: • Inti allerġiku (tbati minn sensittività eċċessiva) għal dapoxetine jew sustanzi oħra ta' Priligy (elenkati f'sezzzjoni 6)
English: The effects of alcohol may be increased if taken with Priligy and you may be more at risk of injury from fainting or from other side effects if you take Priligy with alcohol.
Maltese: L-effetti tal-alkoħol jistgħu jiżdiedu jekk jittieħed ma' Priligy u inti jista' jkollok riskju akbar ta' korriment minn ħass ħażin jew minn effetti sekondarji oħra jekk tieħu Priligy mal-alkoħol.
English: • Lower interest in sex
Maltese: • Tnaqqis ta' interess fis-sess
English: • Tryptophan a medicine to help you sleep
Maltese: • Tryptophan mediċina biex tgħinek torqod
English: NAME OF THE MEDICINAL PRODUCT Priligy 30 mg Film-Coated Tablets Priligy 60 mg Film-Coated Tablets Dapoxetine
Maltese: Priligy 30 mg Pilloli Miksijin b'Rita Priligy 60 mg Pilloli Miksijin b'Rita Dapoxetine
English: LIST OF EXCIPIENTS Contains Lactose.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Fih il-Lactose.
English: Each film-coated tablet contains 30 mg of dapoxetine (as hydrochloride) Each film-coated tablet contains 60 mg of dapoxetine (as hydrochloride)
Maltese: Kull pillola miksija b'rita fiha 60 mg ta' dapoxetine (bħala hydrochloride)
English: • Feeling sick.
Maltese: • Tgħażżiż tas-snien.
English: • Linezolid an antibiotic used to treat infections
Maltese: • Linezolid antibijotiku li jintuża biex jikkura infezzjonijiet
English: • Medicines used to treat migraines.
Maltese: • Mediċini użati għall-kura tal-emigranji.
English: • Feeling dizzy following exertion
Maltese: • Diffikultà biex tikseb jew iżżomm erezzjoni
English: This may help lower your chance of fainting (see ‘Fainting and low blood pressure' in section 4).
Maltese: Dan jista' jgħin biex inaqqas il-possibbiltà li jagħtik ħass ħażin (ara ‘Ħass ħażin u pressjoni baxxa' f'sezzjoni 4).
English: EXPIRY DATE EXP {MM/YYYY}
Maltese: DATA TA' META JISKADI JIS {XX/SSSS}
English: This may reduce the frustration or worry about fast ejaculation.
Maltese: Dan jista' jnaqqas il-frustrazzjoni jew l-inkwiet dwar kemm teġakula malajr.
English: • Do not use Priligy after the expiry date which is stated on the carton after EXP.
Maltese: • Tużax Priligy wara d-data ta' skadenza li tidher fuq il-kartuna wara
English: • Drinking alcohol while taking Priligy may increase your risk of injury from fainting or from other side effects.
Maltese: • Ix-xorb tal-alkoħol waqt li tkun qed tieħu Priligy jista' jżid ir-riskju li inti tkorri minn ħass ħażin jew minn effetti sekondarji oħra.
English: • Loss of sex drive, problems reaching orgasm
Maltese: • Telf ta' aptit ta' sess, problemi biex tikseb orgażmu
English: • Certain other medicines for fungal infection, such as fluconazole
Maltese: • Ċerti mediċini oħra għal infezzjoni bil-moffa, bħal fluconazole
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD CARTON
Maltese: Id-dehra ta' Priligy u l-kontenuti tal-pakkett
English: • Shaking or trembling
Maltese: Tqala u treddigħ
English: • You also have another sexual problem, such as erectile dysfunction.
Maltese: • Inti għandek ukoll problema sesswali oħra, bħal disfunzjoni erettili.
English: • Feeling dizzy
Maltese: • Tertir jew tregħid
English: • Certain medicines used to treat high blood pressure and chest pain (angina) (such as verapamil and diltiazem), or enlarged prostate, as these medicines may also lower your blood pressure, possibly upon standing
Maltese: • Ċerti mediċini użati biex jikkuraw pressjoni għolja u uġigħ fis-sider (anġina) (bħal verapamil u diltiazem), jew prostata kbira, minħabba li dawn il-mediċini jistgħu ukoll ibaxxulek il pressjoni, x'aktarx malli tqum bilwieqfa
English: SUMMARY OF PRODUCT CHARACTERISTICS
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: • Feeling tired or sleepy, yawning
Maltese: • Tħossok irritabbli, anzjuż, aġitat jew bla kwiet
English: • Sudden onset of sleep
Maltese: • Tħossok stordut wara li titħabat
English: • Certain other medicines for HIV, such as amprenavir and fosamprenavir
Maltese: • Ċerti mediċini oħra għall-HIV, bħal amprenavir u fosamprenavir
English: SPECIAL STORAGE CONDITIONS
Maltese: TAL-PRODOTT MEDIĊINALI
English: • Headache
Maltese: • Uġigħ ta' ras
English: • Medicines for mental health problems other than depression
Maltese: • Mediċini għal problemi ta' saħħa mentali ħlief dawk għad-depressjoni
English: • You drink alcohol (see section “Taking Priligy with food and drink”)
Maltese: • Inti tixrob l-alkoħol (ara s-sezzjoni “Meta tuża Priligy ma' l-ikel u max-xorb”)
English: Jinarc is available as tablets (15, 30, 45, 60 and 90 mg).
Maltese: Jinarc jiġi bħala pilloli (15, 30, 45, 60 u 90 mg).
English: Further information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni fuq Jinarc tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Jinarc received a marketing authorisation valid throughout the EU on 27 May 2015.
Maltese: Jinarc irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-27 ta' Mejju 2015.
English: The second study included 1,370 patients with moderately to severely reduced kidney function.
Maltese: It-tieni studju inkluda 1,370 pazjent b'funzjoni tal-kliewi mnaqqsa moderatament sa severament.
English: Jinarc contains the active substance tolvaptan.
Maltese: Jinarc fih is-sustanza attiva tolvaptan.
English: Patients should be started with a dose of 45 mg in the morning and 15 mg in the evening (45+15 mg), and the dose should then be increased to 60+30 mg or 90+30 mg, depending on the medicine's side effects.
Maltese: Il-pazjenti għandhom jinbdew b'doża ta' 45 mg filgħodu u 15 mg filgħaxija (45+15 mg), u d-doża mbagħad għandha tiżdied għal 60+30 mg jew 90+30 mg, skont l-effetti sekondarji tal-mediċina.
English: Other information about Jinarc
Maltese: Informazzjoni oħra dwar Jinarc
English: The active substance in Jinarc, tolvaptan, is a vasopressin-2-receptor antagonist: it blocks receptors (targets) in the kidneys for the hormone vasopressin.
Maltese: Is-sustanza attiva f'Jinarc, it-tolvaptan, hija antagonista tar-riċettur vasopressin-2: din timblokka rriċetturi (il-miri) fil-kliewi għall-ormon vasopressin.
English: As for all medicines, data on the use of Jinarc are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Jinarc hija ssorveljata kontinwament.
English: In 262 patients with severely reduced kidney function, the decline in kidney function was 17% less with Jinarc after 1 year of treatment compared with placebo.
Maltese: F'262 pazjent b'funzjoni tal-kliewi indebolita severament, it-tnaqqis filfunzjoni tal-kliewi kien 17 % inqas b'Jinarc wara sena ta' kura meta mqabbel mal-plaċebo.
English: The first study included 1,445 patients with normal or moderately reduced kidney function, and measured the change in kidney size after 3 years of treatment.
Maltese: L-ewwel studju inkluda 1,445 pazjent b'funzjoni tal-kliewi normali jew imnaqqsa moderatament, u kejjel il-bidla fid-daqs tal-kliewi wara 3 snin ta' kura.
English: Jinarc may increase blood levels of certain liver enzymes (a sign of possible liver problems).
Maltese: Jinarc jista' jżid il-livelli ta' ċerti enzimi talfwied fid-demm (sinjal ta' problemi possibbli fil-fwied).
English: What are the risks associated with Jinarc?
Maltese: X'inhuma r-riskji assoċjati ma' Jinarc?
English: In patients taking placebo, the total size of the kidneys increased by 19% whereas in those taking Jinarc the increase was 10%.
Maltese: Fil-pazjenti li kienu qegħdin jieħdu plaċebo, id-daqs totali tal-kliewi żdied bi 19 %, filwaqt li f'dawk li kienu qegħdin jieħdu Jinarc iż-żieda kienet ta' 10 %.
English: Jinarc is a medicine used to treat adults with autosomal dominant polycystic kidney disease.
Maltese: Jinarc huwa mediċina li tintuża biex tikkura adulti b'marda poliċistika tal-kliewi awtosomali dominanti.
English: The most common side effects with Jinarc (which may affect more than 2 in 10 people) are thirst, polyuria (increase in urine production), nocturia (need to pass urine at night) and pollakiuria (increased need to pass urine during the day).
Maltese: L-effetti sekondarji l-aktar komuni b'Jinarc (li jistgħu jaffettwaw aktar minn 2 persuni minn kull 10) huma għatx, polijurja (żieda fil-produzzjoni tal-awrina), nokturja (bżonn li tgħaddi l-awrina bil-lejl) u pollakijurja (bżonn miżjud li tgħaddi l-awrina matul il-jum).
English: Jinarc can be started in patients with normal to severely reduced kidney function and whose disease is progressing rapidly.
Maltese: Jinarc jista' jinbeda f'pazjenti b'funzjoni tal-kliewi normali sa mnaqqsa severament u li l-marda tagħhom tkun qiegħda tipprogressa malajr.
English: The company that markets Jinarc will provide patients and doctors expected to use the medicine with information on the risk of liver toxicity and on the importance of preventing pregnancy during treatment.
Maltese: Il-kumpanija li tqiegħed Jinarc fis-suq ser tipprovdi lill-pazjenti u lit-tobba li mistennija jużaw ilmediċina informazzjoni dwar ir-riskju ta' tossiċità tal-fwied u dwar l-importanza tal-prevenzjoni tat tqala waqt il-kura.
English: This is an inherited condition in which numerous fluid-filled cysts develop in the kidneys, which eventually reduce kidney function and can cause the kidneys to fail.
Maltese: Din hija kondizzjoni ereditarja li fiha jiżviluppaw diversi ċisti mimlijin bi fluwidu fil-kliewi, li eventwalment inaqqsu l-funzjoni tal-kliewi u jistgħu jikkawżaw insuffiċjenza tal-kliewi.
English: It must not be used in patients with hypernatraemia (increased sodium levels in the blood) and in patients who are allergic to tolvaptan or medicines that are similar to tolvaptan, so-called benzazepines or their derivatives.
Maltese: Dan m'għandux jintuża f'pazjenti b'ipernatremija (żieda fil-livelli ta' sodju fid-demm) u f'pazjenti li jkunu allerġiċi għal tolvaptan jew għal mediċini li huma simili għal tolvaptan, l-hekk imsejħa ‘benzazepines' jew id-derivattivi tagħhom.
English: Results showed that in patients treated with Jinarc the decline in kidney function was 35% less than with placebo after 1 year of treatment.
Maltese: Irriżultati wrew li f'pazjenti kkurati b'Jinarc, it-tnaqqis fil-funzjoni tal-kliewi kien 35 % inqas milli bilplaċebo wara sena ta' kura.
English: Jinarc can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in treating autosomal dominant polycystic kidney disease and with knowledge about the risks of treatment with Jinarc.
Maltese: Jinarc jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda u tiġi sorveljata minn tabib li jkollu esperjenza fil-kura tal-marda poliċistika tal-kliewi awtosomali dominanti u b'għarfien dwar ir-riskji ta' kura b'Jinarc.
English: For the full list of side effects reported with Jinarc, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Jinarc, ara l-fuljett ta' tagħrif.