FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots).
Maltese: Din il-mediċina tintuża għat-trattament tal-ipertensjoni arterjali pulmonarja (i.e., pressjoni għolja tad-demm fil-pulmuni) u ipertensjoni pulmonarja tromboembolika kronika (i.e., pressjoni għolja tad-demm fil-pulmuni kkawżata minn ċapep fid demm).
English: After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range (25-100 mg).
Maltese: Wara doża orali ta' sildenafil l-AUC u Cmax jizdiedu fi proporzjon mad-doża fuq il-medda rrakkomandata tad-doża (25-100-mg).
English: Sildenafil Teva is available in blister packs of 2, 4, 8 and 12 tablets, and perforated unit dose blisters containing 10 x 1 tablet.
Maltese: Sildenafil Teva jiġi f'pakketti b'folji ta' 2, 4, 8 u 12-il pillola, u folji perforati li fihom 10 x 1 pillola ta' doża waħda.
English: Cerebrovascular accident, Transient ischaemic attack, Seizure,* Seizure recurrence,* Syncope
Maltese: Attakk iskimiku temporanju, attakk ta' puplesija,* Rikorrenza ta' puplesija,* Sinkope
English: Non-arteritic anterior ischaemic optic neuropathy (NAION), * Retinal vascular occlusion,* Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect,
Maltese: Emorraġija retinali, Retinopatija arterjosklerotika, Disturb retinali, Glawkoma, Difett fil-kamp viżiv,
English: Sildenafil Teva 25 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8 or 12 tablets.
Maltese: Sildenafil Teva 25 mg pilloli miksija b'rita Strixxa tal-PVC/Aluminju f'kartun ta' 2, 4, 8 jew 12-il pillola.
English: In volunteers with severe renal impairment (creatinine clearance <30 mL/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100 % and 88 % respectively compared to age-matched volunteers with no renal impairment.
Maltese: F'voluntiera b'indeboliment sever tal-kliewi (tneħħija ta' kreatinina < 30 mL/min), it-tneħħija ta' sildenafil naqset, u wasslet għal żidiet medji tal-AUC u Cmax ta' 100 % u 88 % rispettivament meta mqabbla ma' voluntiera tal-istess età li ma kellhomx ħsara fil-kliewi.
English: Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Maltese: Effetti fuq il-vista Każijiet ta' difetti fil-vista relatati mal-amministrazzjoni ta' sildenafil u inibituri ta' PDE5 oħrajn ġew irrapportati b'mod spontanju (ara sezzjoni 4.8).
English: This is most likely to happen within 4 hours after taking Sildenafil Teva.
Maltese: Dan ġeneralment iseħħ fi żmien 4 sigħat wara li tkun ħadt Sildenafil Teva.
English: In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh A and B) sildenafil clearance was reduced, resulting in increases in AUC (84 %) and Cmax (47 %) compared to age-matched volunteers with no hepatic impairment.
Maltese: Insuffiċjenza tal-fwied F'voluntiera b'ċirrożi ħafifa għal moderata tal-fwied ( Child-Pugh A u B) it-tneħħija ta' sildenafil tnaqqas, u rriżulta f żidiet fl-AUC (84 %) u Cmax (47 %) mqabbel ma' voluntiera tal-istess età li ma kellhomx ħsara fil-fwied.
English: Sildenafil Teva is available in blister packs of 2, 4, 8, 12 and 24 tablets, and perforated unit dose blisters containing 10 x 1 tablet.
Maltese: Sildenafil Teva jiġi f'pakketti b'folji ta' 2, 4, 8, 12 u 24-il pillola, u folji perforati li fihom 10 x 1
English: EU/1/09/584/008 EU/1/09/584/009 EU/1/09/584/010 EU/1/09/584/011 EU/1/09/584/012 EU/1/09/584/019
Maltese: EU/1/09/584/008 EU/1/09/584/009 EU/1/09/584/010
English: Respiratory, thoracic and mediastinal disorders
Maltese: Fibrillazzjoni atrijali, Anġina instabbli
English: The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Maltese: <90/50 mmHg), puplesija jew attakk tal-qalb reċenti u mard magħruf ereditarju ta' degenerazzjoni tar-retina bħal retinitis pigmentosa (minoranza ta' dawn il-pazjenti għandhom mard genetiku ta'
English: Tablet core
Maltese: Il-metabolit
English: At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7, 8, 9, 10 and 11.
Maltese: PDE2, 3, 4, 7, 8, 9,10 u 11.
English: In order for Sildenafil Teva to be effective, sexual stimulation is required.
Maltese: Biex Sildenafil Teva ikun effettiv, ikun hemm bżonn ta' stimulazzjoni sesswali.
English: Effects of other medicinal products on sildenafil
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Effetti ta' prodotti mediċinali oħra fuq sildenafil
English: Sildenafil Teva 25 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Maltese: Kull pillola fiha sildenafil citrate ekwivalenti għal 25 mg ta' sildenafil.
English: Sildenafil Teva 25 mg film-coated tablets sildenafil
Maltese: Sildenafil Teva 25 mg pilloli miksija b'rita sildenafil
English: − If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Maltese: • Jekk inti għandek ċertu mard rari ereditarju tal-għajnejn (bħal retinitis pigmentosa).
English: • A sudden decrease or loss of vision - this occurs rarely
Maltese: • Tnaqqis jew telf fil-vista f'daqqa - dan iseħħ rari
English: Sildenafil Teva 50 mg film-coated tablets sildenafil
Maltese: Sildenafil Teva 50 mg pilloli miksija b'rita sildenafil
English: Sildenafil Teva 100 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Maltese: Kull pillola fiha sildenafil citrate ekwivalenti għal 100 mg ta' sildenafil.
English: Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP.
Maltese: Studji in vitro wrew li sildenafil huwa selettiv għal PDE5, li huwa involut fil-proċess ta' twebbis.
English: Sildenafil Teva 50 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Maltese: Kull pillola fiha sildenafil citrate ekwivalenti għal 50 mg ta' sildenafil.
English: EU/1/09/584/014 EU/1/09/584/015 EU/1/09/584/016 EU/1/09/584/017 EU/1/09/584/018 EU/1/09/584/020
Maltese: EU/1/09/584/011 EU/1/09/584/012 EU/1/09/584/019
English: Sildenafil Teva 100 mg film-coated tablets sildenafil
Maltese: Sildenafil Teva 100 mg pilloli miksija b'rita sildenafil
English: Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
Maltese: Rari (jistgħu jaffettwaw sa 1 persuna minn kull 1,000): ħass ħażin, attakk tal-qalb, taħbit tal-qalb irregolari, fluss tad-demm imnaqqas temporanjament għal partijiet tal-moħħ, sensazzjoni ta' għafis filgerżuma, ħalq imtextex, fsada fuq wara tal-għajn, vista doppja, tnaqqis fl-akutezza fil-vista, sensazzjoni anormali fl-għajn, nefħa tal-għajn jew tal-kappell tal-għajn, frak żgħar jew tikek fil-vista tiegħek, tara raġġieri madwar id-dwal, twessigħ tal-ħabba tal-għajn, telf fil-kulur tal-abjad tal-għajn, fsada fil-pene, preżenza ta' demm fis-semen, imnieħer xott, nefħa fuq ġewwa tal-imnieħer, tħossok irritabbli u tnaqqis f'daqqa jew telf ta' smigħ.
English: Deafness
Maltese: ipostesja
English: The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section
Maltese: It-teħid flimkien ta' inibituri ta' PDE5, inkluż sildenafil, ma' stimulaturi ta' guanylate cyclase, bħal riociguat, huwa kontraindikat għax hemm il-possibbiltà li dan iwassal għal ipotensjoni sintomatika
English: Use in patients taking other medicinal products
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
Maltese: Sildenafil huwa mneħħi prinċipalment mill-iżoenzimi mikrożomali CYP3A4 (rotta ewlenija) u
English: Concomitant use with ritonavir
Maltese: TIKKETTAR U FULJETT TA' TAGĦRIF
English: Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90 % higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Maltese: Voluntiera anzjani b'sahhithom (65 sena jew iżjed) kellhom tneħħija mnaqqsa ta' sildenafil, li irrizulta f'madwar 90 % konċentrazzjonijiet ogħla ta' sildenafil fil-plażma u l-metabolit attiv N-desmethly meta mqabbel ma' dawk li nstabu f'voluntiera żgħażagħ b'sahhithom (18-45 sena).
English: Elderly
Maltese: medjastinali
English: The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and.
Maltese: L-aktar reazzjonijiet avversi li ġew irrappurtati minn fost il-pazjenti li użaw sildenafil fl-istudji klinici kienu uġigħ ta' ras, fwawar, dispepsja, sadd fl-imnifsejn, sturdament, dardir, fwawar ta' sħana, disturb viżiv, ċijanopsija u vista mċajpra.
English: Myocardial infarction, Ventricular arrhythmia,* Atrial fibrillation, Unstable angina
Maltese: Infart mijokardijaku, Arritmija ventrikulari,*
English: Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
Maltese: Komuni (jistgħu jaffettwaw sa persuna minn kull 10): dardir, ħmura fil-wiċċ, fwawar (sintomi jinkludu sensazzjoni f'daqqa ta' sħana fil-parti ta' fuq ta' ġismek), indiġestjoni, vista mżewwqa b'xi kulur, vista mċajpra, disturb fil-vista, sadd fl-imnifsejn u sturdament.
English: The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see section 4.3).
Maltese: Il-gruppi li ġejjin ma kinux rappreżentati sew jew ġew esklużi fil-provi kliniċi: pazjenti b'interventi kirurġiċi fil-pelvi, pazjenti wara r-radjuterapija, pazjenti b'indeboliment fil-kliewi jew tal-fwied u pazjenti b'ċertu kundizzjonijiet kardjovaskulari (ara sezzjoni 4.3).
English: Sildenafil Teva is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
Maltese: Sildenafil Teva huwa trattament għal irġiel adulti li għandhom problema biex jibbies il-pene, li kultant imsejjħa impotenza.
English: There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).
Maltese: Ma kienx hemm effett fuq il-morfologija jew il-motilità tal-isperma wara li voluntiera b'saħħithom ħadu doża waħda ta' 100 mg mill-ħalq (ara sezzjoni 4.6).
English: With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
Maltese: Bl-eċċessjoni ta' ritonavir li mhux rakkomandat li jingħata sildenafil miegħu (ara sezzjoni 4.4) doża tal-bidu ta' 25 mg għandha tiġi kunsidrata f pazjenti li fl-istess hin ikunu fuq trattament ta' inibituri ta' CYP3A4
English: Further information on clinical trials
Maltese: Kontenut tal-pakkett u informazzjoni oħra dwar provi kliniċi
English: The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80 % of administered oral dose) and to a lesser extent in the urine (approximately 13 % of administered oral dose).
Maltese: Wara li jittieħed jew mill-ħalq jew minn ġol-vina, sildenafil jiġi eliminat bħala metaboliti prinċipalment mal-ippurgar (madwar 80 % tad-doża orali) u f'proporzjon inqas fl-urina (madwar 13 % tad-doża orali mogħtija). Farmakokinetika fi gruppi speċjali ta' pazjenti
English: Sildenafil Teva 25 mg film-coated tablets
Maltese: Sildenafil Teva 25 mg pilloli miksija b'rita
English: Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Maltese: Nitric oxide mbagħad jattiva l-enzima guanylate cyclase, li tirriżulta f'livelli miżjuda ta' cyclic guanosine monophosphate (cGMP), li tipproduċi rilassament fil-muskoli melliesa tal-corpus cavernosum u tikkawża d-dħul tad-demm Sildenafil huwa impeditur potenti u silettiv ta' cGMP specific phosphodiesterase type 5 (PDE5) fil-corpus cavernosum, fejn PDE5 huwa responsabbli għad-degradazzjoni ta' cGMP. Sildenafil għandu sit periferali ta' azzjoni fuq erezzjonijiet.
English: − If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.
Maltese: • Jekk inti qed tieħu mediċini li huma magħrufin li jiġġeneraw nitric oxide, bħal amyl nitrite (“poppers”), dawn ukoll jistgħu jikkawżaw tnaqqis perikoluż fil-pressjoni tad-demm potenzjalment ta' ħsara.
English: How to take Sildenafil Teva
Maltese: Sildenafil Teva.
English: Sildenafil Teva 50 mg film-coated tablets
Maltese: Sildenafil Teva 50 mg pilloli miksija b'rita
English: In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan, (an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19) at steady state (125 mg twice a day) with sildenafil at steady state (80 mg three times a day) resulted in 62.6% and 55.4% decrease in sildenafil AUC and Cmax, respectively.
Maltese: flimkien ma' sildenafil fi stat fiss (80 mg tlett darbiet kuljum) irriżulta fi tnaqqis ta' 62.6% u 55.4% flAUC u Cmax ta' sildenafil rispettivament.
English: Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of sildenafil.
Maltese: arritmja ventrikulari, emorraġija ċerebrovaskulari, attakk iskimiku transitorju, pressjoni għolja u pressjoni baxxa.
English: Sildenafil Teva 100 mg film-coated tablets
Maltese: KARTUNA-Sildenafil Teva 100 mg Pilloli miksija b'rita
English: Haematuria
Maltese: Manifattur
English: When the NO/cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil results in increased corpus cavernosum levels of cGMP.
Maltese: PDE5 minn sildenafil tirrizulta f'livelli aktar għoljin ta cGMP fil-corpus cavernosum.
English: Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil
Maltese: Kull pillola fiha sildenafil citrate ekwivalenti għal 100 mg ta' sildenafil
English: At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/mL, compared to approximately 5 ng/mL when sildenafil was administered alone.
Maltese: F'24 siegħa, il-livelli ta' sildenafil fil-plażma kienu għadhom bejn wieħed u ieħor 200 ng/mL, imqabblin ma' bejn wieħed u ieħor 5 ng/mL meta sildenafil ingħata waħdu.
English: • Importance of evaluating liver function tests (LFTs), TSH and signs/symptoms of irARs before each treatment.
Maltese: • Importanza li jiġu evalwati t-testijiet tal-funzjoni tal-fwied (LFTs), TSH u sinjali/sintomi ta' irARs qabel kull kura.
English: o Gastrointestinal: diarrhea, bloody stool, abdominal pain, nausea, or vomiting o Liver: yellowing of your skin or whites of your eyes o Skin: rash, blisters and/or peeling, mouth sores o Eye: blurred vision, vision changes, eye pain, o General: fever, headache, feeling tired, dizziness or fainting, dark urine, bleeding, weakness, numbness of legs, arms, or faces, changes in behavior, such as less sex drive, being irritable or forgetful
Maltese: o Gastrointestinali: dijarrea, ippurgar bid-demm, uġigħ addominali, dardir, jew rimettar o Fwied: sfurija tal-ġilda jew tal-abjad ta' għajnejk o Ġilda: raxx, bżieżaq u/jew tqaxxir, feriti fil-ħalq o Għajnejn: vista mċajpra, tibdil fil-vista, uġigħ fl-għajnejn, o Ġenerali: deni, uġigħ ta' ras, tħossok għajjien/a, sturdament jew ħass ħażin, awrina skura,
English: • Patient Information Brochures including Alert Cards
Maltese: Fuljetti ta' Informazzjoni għall-Pazjent inkluż Kards ta' Twissija
English: Key elements of the Healthcare Professional FAQ Brochure (Q&A format):
Maltese: Elementi ewlenin tal-Fuljett ta' Mistoqsijiet Komuni għall-Professjonisti tal-Kura tas-Saħħa (format Mistoqsija u Tweġiba):
English: Key elements for the Patient Information Brochure and Alert Card:
Maltese: Elementi ewlenin għall-Fuljett ta' Informazzjoni tal-Pazjent u l-Kard ta' Twissija:
English: • Follow-up of patients due to late onset (months after treatment) of irARs
Maltese: • Follow-up tal-pazjenti minħabba feġġa tardiva (xhur wara l-kura) ta' irARs
English: • List of important immune-related adverse reactions (irARs) and their symptoms, as outlined in section 4.4 of the Summary of Product Characteristics (SmPC): o Inflammation of the gastrointestinal tract, such as colitis, which can lead to bowel perforation o Inflammation of the liver, such as hepatitis, which can lead to liver failure o Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis) o Inflammation of the nerves that can lead to neuropathy o Inflammation of the endocrine system.
Maltese: o Infjammazzjoni tal-passaġġ gastrointestinali bħal kolite, li tista' twassal għal perforazzjoni tal musrana o Infjammazzjoni tal-fwied, bħal epatite, li tista' twassal għal ħsara fil-fwied o Infjammazzjoni tal-ġilda li tista' twassal għal reazzjoni severa tal-ġilda (nekroliżi epidermali tossika) o Infjammazzjoni tan-nervituri li tista' twassal għal newropatija o Infjammazzjoni tas-sistema endokrinali, inkluż il-glandoli adrenali, pitwitarji jew tat-tirojde o Infjammazzjoni tal-għajnejn o irARs relatati oħrajn (eż. pulmonite, glomerulonefrite, ħsara f'aktar minn organu wieħed…)
English: The Card reminds patients about key symptoms that need to be reported immediately to the physician/nurse.
Maltese: Il-Kard tfakkar lill-pazjenti dwar sintomi ewlenin li jeħtieġu li jiġu rrapportati minnufih lit-tabib/infermier/a.
English: including the adrenal, pituitary, or thyroid glands o Inflammation of the eyes o Other related irARs (e.g. pneumonitis, glomerulonephritis, multi-organ failure…) o Severe infusion reaction
Maltese: L-Istati Membri għandhom jagħmlu ċert li l-kundizzjonijiet u r-restrizzjonijiet kollha fir-rigward tal-użu sikur u effettiv tal-prodott mediċinali deskritt hawn taħt huma implimentati:
English: • The importance of carrying the detachable wallet-sized Patient Alert Card at all times to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals).
Maltese: • L-importanza li ma tippruvax tikkura inti stess kwalunkwe sintomu mingħajr ma tikkonsulta malprofessjonista tal-Kura tas-saħħa tagħhom l-ewwel.
English: • Description of the main symptoms of irARs and the importance of notifying their treating physician immediately if symptoms occur, persist or worsen.
Maltese: • Deskrizzjoni tas-sintomi ewlenin ta' irARs u tal-importanza li dawn jiġu nnotifikati minnufih lit-tabib li jkun qiegħed jagħti l-kura jekk iseħħu sintomi, jew jekk is-sintomi jippersistu jew jaggravaw.
English: (See sections 4.2 and 5.2).
Maltese: (Ara ttaqsimiet 4.2 u 5.2).
English: Overall mortality
Maltese: Mortalità totali
English: Nervous system disorders parkinsonism c,
Maltese: Disturbi fis-sistema nervuża parkinsoniżmu c,
English: Day 8
Maltese: Jum 8
English: logrank test, p-value<0.0001
Maltese: test logrank, valur p <0.
English: Week 19 to Week 24, inclusive
Maltese: Ġimgħa 19 sa Ġimgħa 24, inklużivi
English: TREVICTA (N=160)
Maltese: TREVICTA (N=160) Plaċebo (N=145)
English: Extrapyramidal symptoms (EPS)
Maltese: Sintomi ekstrapiramidali (EPS - extrapyramidal symptoms)
English: Excipients: polysorbate 20, polyethylene glycol 4000, citric acid monohydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, water for injections
Maltese: Eċċipjenti: polysorbate 20, polyethylene glycol 4000, citric acid monohydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, ilma għall-injezzjonijiet
English: In the clinical trials of TREVICTA, akathisia, dyskinesia, dystonia, parkinsonism, and tremor were reported in 3.9%, 0.8%, 0.9%, 3.6%, and 1.4% of subjects, respectively.
Maltese: Fil-provi kliniċi ta' TREVICTA, akatisja, diskineżja, distonja, parkinsoniżmu u rogħda kienu rrappurtati fi 3.9%, 0.8%, 0.9%, 3.6%, u 1.4% tal-individwi, rispettivament.
English: TREVICTA contains sodium
Maltese: TREVICTA fih sodium
English: The pharmacological activity of the (+)- and (-)-paliperidone enantiomers are qualitatively and quantitatively similar.
Maltese: L-attività farmakoloġika tal-enantjomeri (+) u (-) ta' paliperidone hija simili mill-aspetti kwalitattivi kif ukoll kwantitattivi.
English: The plasma protein binding of racemic paliperidone is 74%.
Maltese: L-irbit ta' paliperidone raċemiku mal-proteini tal-plażma huwa 74%.
English: Check suspension
Maltese: Iċċekkja s-suspensjoni
English: > 3½ months up to 4 months
Maltese: > 3½ xhur sa 4 xhur
English: Week number after last TREVICTA dose Week 12 to Week 18, inclusive
Maltese: Numru tal-ġimgħa wara l-aħħar doża ta' TREVICTA Ġimgħa 12 sa Ġimgħa 18, inklużivi
English: CARDBOARD CARTON
Maltese: KARTUNA TAL-KARTUN
English: Citric acid monohydrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Citric acid monohydrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide (għal aġġustament tal-pH) Ilma għall-injezzjonijiet
English: In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicines metabolised by cytochrome P450 isozymes, including CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4, and CYP3A5.
Maltese: Studji in vitro filmikrożomi tal-fwied tal-bniedem urew li paliperidone ma jinibixxix b'mod sostanzjali l-metaboliżmu ta' mediċini metabolizzati bl-isozimi taċ-ċitokroma P450, inklużi CYP1A2, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4, u CYP3A5.
English: The hazard ratio was 3.81 (95% CI: 2.08, 6.99) indicating a 74% decrease in relapse risk with TREVICTA compared to placebo.
Maltese: Il-proporzjon ta' periklu (hazard ratio) kien ta' 3.81 (95% CI: 2.08, 6.99) li jindika tnaqqis ta' 74% fir-riskju ta' rikaduta bi TREVICTA meta mqabbel mal-plaċebo.
English: Concomitant use of TREVICTA with psychostimulants
Maltese: L-użu konkomitanti ta' TREVICTA ma' psikostimulanti
English: Figure 1: Kaplan-Meier plot of time to relapse - Final analysis
Maltese: Figura 1: Plot Kaplan-Meier taż-żmien għar-rikaduta - Analiżi finali
English: Body mass index (BMI)/body weight
Maltese: Indiċi tal-massa tal-ġisem (BMI - body mass index)/piż tal-ġisem
English: Neuroleptic malignant syndrome
Maltese: Sindrom newrolettiku malinn
English: Immune system disorders hypersensitivity anaphylactic reaction
Maltese: Disturbi fis-sistema immuni sensittività eċċessiva reazzjoni anafilattika