FrancophonIA/ELRC3.0 huggingface dataset:
English: Hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy
Maltese: Alluċinazzjoni, attakk ta' paniku, irrekwitezza aġitazzjoni, depressjoni, burdata depressa, burdata ta' entużjażmu, agressjoni, bidla filburdata minn tajba ħafna għal ħażina ħafna fi żmien qasir, spersonalizzazzjoni, diffikultà biex issib kelma, ħolm anormali, żieda fil-libido, inkapaċità li tilħaq orgażmu, apatija
English: There are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g. intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
Maltese: Tnaqqis fil-funzjoni gastrointestinali fil-parti t'isfel Kien hemm rapporti ta' episodji assoċjati mal- funzjoni gastrointestinali tal-parti t'isfel (eż. imblukkar tal-intestini, ileus paralitiku, stitikezza) ) fl-esperjenza ta' wara t-tqegħid fis-suq, meta pregabalin ġie mogħti flimkien ma' mediċini li għandhom il-potenzjal li jikkawżaw stitikezza, bhal analġesiċi opjojd.
English: The AUC was lower by 30% in paediatric patients below a weight of 30 kg due to an increased body weight adjusted clearance of 43% for these patients in comparison to patients weighing ≥ 30 kg.
Maltese: L-AUC kien inqas bi 30% f'pazjenti pedjatriċi b'piż ta' inqas minn 30 kg minħabba żieda fittneħħija aġġustata għall-piż tal-ġisem ta' 43% għal dawn il-pazjenti meta mqabbla ma' pazjenti li kienu jiżnu ≥30 kg.
English: Population pharmacokinetic analysis showed that creatinine clearance was a significant covariate of pregabalin oral clearance, body weight was a significant covariate of pregabalin apparent oral volume of distribution, and these relationships were similar in paediatric and adult patients.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni wriet li t-tneħħija tal-krejatinina kienet kovarjant sinifikanti ta' tneħħija orali ta' pregabalin, il-piż tal-ġisem kien kovarjant sinifikanti tal-volum apparenti tad-distribuzzjoni ta' pregabalin mogħti mill-ħalq, u dawn ir-relazzjonijiet kienu simili f'pazjenti pedjatriċi u adulti.
English: Each hard capsule contains 25 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 25 mg pregabalin.
English: Each hard capsule contains 300 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 300 mg pregabalin.
English: belongs to a group of medicines used to treat epilepsy, neuropathic pain and generalised anxiety disorder (GAD) in adults.
Maltese: k.s. jappartjeni għal grupp ta' mediċini li jintużaw għall-kura ta l-epilessija, l-uġigħ nevrotiku u d-disturb ta' ansjetà ġeneralizzata (GAD - generalised anxiety disorder) fl-adulti.
English: 200 mg hard capsules Pregabalin Zentiva k.s.
Maltese: k.s. 200 mg kapsuli ibsin Pregabalin Zentiva
English: 75 mg hard capsules Pregabalin Zentiva k.s.
Maltese: k.s. 75 mg kapsuli ibsin Pregabalin Zentiva
English: 225 mg hard capsules Pregabalin Zentiva k.s.
Maltese: k.s. 225 mg kapsuli ibsin Pregabalin Zentiva k.s. 300 mg kapsuli ibsin Pregabalin
English: Neutropaenia
Maltese: Tqala
English: Each hard capsule contains 200 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 200 mg pregabalin.
English: • Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood, mental impairment, difficulty with thinking, increase in sexual interest, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation.
Maltese: • Bidla fil-mod kif tħares lejk innifsek, irrekwitezza, depressjoni, aġitazzjoni bidliet fil-burdata, diffikultà biex issib il-kelma, alluċinazzjonijiet, ħolm anormali, attakk ta' paniku, apatja, agressjoni, burdata ta' entużjażmu, indeboliment mentali, diffikultà biex taħseb, żieda fl-interess sesswali, problemi fil-funzjoni ta' natura sesswali li jinkludu inkapaċità li tilħaq orgażmu, dewmien fl-ejakulazzjoni.
English: • Some patients taking pregabalin have reported symptoms suggesting an allergic reaction.
Maltese: • Xi pazjenti li kienu qed jieħdu pregabalin irrappurtaw sintomi li jindikaw reazzjoni allerġika.
English: looks like and contents of the pack 25 mg capsules Light grey cap and light grey body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “25”, containing almost white powder.
Maltese: Kapsuli ta' 225 mg Għatu opak kulur il-ġilda u korp griż ċar; b'tul ta' madwar 19.4 mm, kapsula iebsin tal-ġelatina stampata b'“225”, li fiha trab kważi abjad.
English: As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in table 1 determined using the following formula.
Maltese: Billi t-tneħħija ta' pregabalin hija direttament proporzjonali mat-tneħħija talkreatinina (ara sezzjoni 5.2), it-tnaqqis fid-doża f'pazjenti b'funzjoni renali kompromessa jrid ikun individwalizzat skond it-tneħħija tal-kreatinina (CLcr), kif indikat f'tabella 1 stabbilit billi tintuża lformula li ġejja.
English: Since pregabalin does not undergo significant metabolism and is excreted predominantly as unchanged drug in the urine, impaired liver function would not be expected to significantly alter pregabalin plasma concentrations.
Maltese: Billi pregabalin ma jiġix metabolizzat b'mod sinifikanti u jitneħħa fil-biċċa l-kbira bħala mediċina mhux mibdula fl-awrina, indeboliment fil-funzjoni tal-fwied mhux mistenni li jbiddel b'mod sinifikanti lkonċentrazzjonijiet ta' pregabalin fil-plasma.
English: • Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring.
Maltese: • Sensittività eċċessiva, nefħa fil-wiċċ, ħakk, urtikarja, imnieħer inixxi, fsada mill-imnieħer, sogħla, inħir.
English: This decrease in pregabalin oral clearance is consistent with decreases in creatinine clearance associated with increasing age.
Maltese: Dan it-tnaqqis fittneħħija orali ta' pregabalin huwa konsistenti mat-tnaqqis fit-tneħħija ta' krejatinina assoċjat mat-tkabbir fl-età.
English: Excipient with known effect: Each hard capsule also contains 10 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha wkoll 10 mg lactose monohydrate.
English: 300 mg hard capsules Capsule cap
Maltese: Pregabalin Zentiva k.s. 300 mg kapsuli ibsin Għatu tal-kapsula
English: 25 mg hard capsules Pregabalin
Maltese: k.s. 25 mg kapsuli ibsin Pregabalin
English: Excipient with known effect: Each hard capsule also contains 5 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha wkoll 5 mg lactose monohydrate.
English: Red cap and light grey body; approx. 21,7 mm in length, hard gelatin capsule with imprinting “300”, containing almost white powder.
Maltese: Kapsuli ta' 300 mg Għatu aħmar u korp griż ċar; b'tul ta' madwar 21.7 mm, kapsula iebsin talġelatina stampata b'“300”, li fiha trab kważi abjad.
English: Excipient with known effect: Each hard capsule also contains 15 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha wkoll 15 mg lactose monohydrate.
English: Your doctor will prescribe Pregabalin Zentiva k.s.
Maltese: Mediċini oħra u Pregabalin Zentiva k.s.
English: EU/1/16/1166/001 EU/1/16/1166/002 EU/1/16/1166/003 EU/1/16/1166/004 EU/1/16/1166/029 EU/1/16/1166/005
Maltese: EU/1/16/1166/001 EU/1/16/1166/002 EU/1/16/1166/003 EU/1/16/1166/004
English: Flesh opaque cap and light grey body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “225”, containing almost white powder.
Maltese: Għatu opak kulur il-ġilda u korp griż ċar; b'tul ta' madwar 19.4 mm, kapsula iebsa tal-ġelatina stampata b'“225”, li fiha trab kważi abjad.
English: 200 mg capsules Flesh opaque cap and Flesh opaque body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “200”, containing almost white powder.
Maltese: Għatu opak kulur il-ġilda u korp opak kulur il-ġilda; b'tul ta' madwar 19.4 mm, kapsula iebsin tal-ġelatina stampata b'“200”, li fiha trab kważi abjad.
English: 25 mg hard capsules Pregabalin Zentiva k.s.
Maltese: k.s. 25 mg kapsuli ibsin Pregabalin Zentiva
English: • Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased,
Maltese: • Bidliet fir-riżultati tat-testijiet tad-demm u tal-fwied (żieda fil-kreatina phosphokinase fiddemm, żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, tnaqqis fl-għadd ta' pjastrini, newtropenja, żieda fil-krejatinina fid-demm, tnaqqis fil-potassju fid-demm).
English: Relief of the symptoms of GAD as reflected by the Hamilton Anxiety Rating Scale (HAM-A) was observed by Week 1.
Maltese: Solliev tas-sintomi ta' GAD kif rifless mill-Iskala ta' Hamilton għal-Livell ta' Ansjetà (HAM-A) kien osservat mal-Ewwel Ġimgħa.
English: For patients who experienced somnolence the responder rates were 48% on pregabalin and 16% on placebo.
Maltese: Fil-każ tal-pazjenti li esperjenzaw in-ngħas ir-rati tar-rispons kienu 48% fuq pregabalin u 16% fuq il-plaċebo.
English: Printing ink Shellac
Maltese: Intolleranza għal-lactose
English: 50 mg hard capsules Pregabalin Zentiva k.s.
Maltese: Pregabalin Zentiva k.s. 50 mg kapsuli ibsin Pregabalin
English: Light grey cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “50”, containing almost white powder.
Maltese: Kapsuli ta' 50 mg Għatu griż ċar u korp griż ċar; b'tul ta' madwar 14.3 mm, kapsula iebsin talġelatina stampata b'“50”, li fiha trab kważi abjad.
English: Light grey cap and light grey body; approx. 18,0 mm in length, hard gelatin capsule with imprinting “150”, containing almost white powder.
Maltese: Għatu griż ċar u korp griż ċar; b'tul ta' madwar 18.0 mm, kapsula iebsa tal-ġelatina stampata b'“150”, li fiha trab kważi abjad.
English: Creatinine clearance (CLcr) (ml/min)
Maltese: Aġġustment fid-doża ta' pregabalin abbażi tal-funzjoni tal-kliewi Tneħħija tal-krejatinina (CLcr) (ml/min)
English: Red cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “75”, containing almost white powder.
Maltese: Għatu aħmar u korp griż ċar; b'tul ta' madwar 14.3 mm, kapsula iebsa tal-ġelatina stampata b'“75”, li fiha trab kważi abjad.
English: Generalised oedema, face oedema, chest tightness, pain, pyrexia, thirst, chills, asthenia
Maltese: • Ħalq xott, stitikezza, rimettar, gass fl-istonku, dijarea, dardir, nefħa fiż-żaqq.
English: Red cap and red body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “100”, containing almost white powder.
Maltese: Għatu aħmar u korp aħmar; b'tul ta' madwar 15.9 mm, kapsula iebsa tal-ġelatina stampata b'“100”, li fiha trab kważi abjad.
English: Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with either BID or TID dosing.
Maltese: Pregabalin ġie studjat fi 3 provi kliniċi kkontrollati li damu 12-il ġimgħa fejn ingħataw dożi BID jew TID - three times a day.
English: Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
Maltese: Fuq il-bażi tar-rispons u t-tolleranza tal-pazjent individwali, id-doża tista' tiżdied għal 300 mg kuljum wara intervall ta' 3 sa 7 ijiem, u jekk ikun meħtieġ, għal doża massima ta' 600 mg kuljum wara intervall ieħor ta' 7 ijiem.
English: 300 mg hard capsules Pregabalin
Maltese: Pregabalin Zentiva k.s. 300 mg kapsuli ibsin Pregabalin
English: 75 mg hard capsules
Maltese: Pregabalin Zentiva k.s 75 mg kapsuli ibsin
English: Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness
Maltese: Amenorreja, tnixxija mis-sider, tkabbir tas-sider, ginekomastija
English: Withdrawal of concomitant anti-epileptic medicinal products There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Maltese: Twaqqif ta' prodotti mediċinali konkomitanti kontra l-epilessija M'hemmx informazzjoni dwar it-twaqqif ta' prodotti mediċinali konkomitanti kontra l-epilessija, ladarba jkun inkiseb kontroll tal-aċċessjonijiet bi pregabalin fis-sitwazzjoni add-on, bil-għan li tintlaħaq terapija waħdanija bi pregabalin.
English: Pregabalin was excreted into breast milk with average steady-state concentrations approximately 76% of those in maternal plasma.
Maltese: Pregabalin tneħħa fil-ħalib tassider b'medja tal-konċentrazzjonijiet fl-istat fiss ta' madwar 76% ta' dawk fil-plasma materna.
English: Supplementary dosage following haemodialysis (mg)
Maltese: Dożaġġ supplimentari wara l-emodijalisi (mg)
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli bħalissa hija deskritta f'sezzjonijiet 4.8, 5.1 u 5.2 iżda l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-folja u l-kartuna wara “JIS”.
English: In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, CNS adverse reactions and especially somnolence was increased (see section 4.4).
Maltese: Fil-kura ta' uġigħ nevrotiku ċentrali minħabba leżjoni fil-korda spinali, l-inċidenza ta' reazzjonijiet avversi b'mod ġenerali, reazzjonijiet avversi tas-CNS u b'mod speċjali tan-ngħas żdiedet (ara sezzjoni 4.4).
English: Discontinuation of pregabalin
Maltese: Enċefalopatija
English: Pregnancy and breast-feeding
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Komuni
English: • Changes in eyesight, unusual eye movement, changes in vision including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell.
Maltese: • Bidliet viżta tal-għajnejn, moviment mhux normali tal-għajnejn, bidliet fil-viżta ta' l- għajnejn li jinkludu telf tal-viżta , tberrieq ta' dawl, movimenti bl-iskossi, tnaqqis fir-riflessi, attività akbar, sturdament meta tkun qiegħed bil-wieqfa, ġilda sensittiva, telf tat-togħma, sensazzjoni ta' ħruq, rogħda meta tiċċaqlaq, koxjenza mnaqqsa, tintilef minn sensik, ħass ħażin, sensittivita' akbar għall-ħsejjes, tħossok ma tiflaħx.
English: 200 mg hard capsules
Maltese: Kapsuli ta' 200 mg
English: Pregabalin has been studied in 1 controlled clinical trial of 56 week duration with BID dosing.
Maltese: Monoterapija (pazjenti li għadhom kemm ġew dijanjostikati) Pregabalin ġie studjat fi prova klinika waħda kkontrollata li damet 56 ġimgħa b'dożaġġ BID.
English: • Changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances.
Maltese: • Tibdil fir-riżultati elettriċi (ECG) tal-qalb li jirrifletttu disturbi fir-ritmu tal-qalb.
English: There have been reports in the post-marketing experience of hypersensitivity reactions, including cases of angioedema.
Maltese: Reazzjonijiet oħra rrapportati mill-esperjenza ta' wara t-tqegħid fis-suq huma inklużi bil-korsiv fillista ta' hawn isfel.
English: contains
Maltese: Tel:
English: EU/1/16/1166/020 EU/1/16/1166/021 EU/1/16/1166/034 EU/1/16/1166/022
Maltese: EU/1/16/1166/021 EU/1/16/1166/034
English: Repeated intermittent use:
Maltese: Użu intermittenti ripetut:
English: Gedeon Richter Plc, 1103 Budapest Gyömrői út 19-21 Hungary
Maltese: Gedeon Richter Plc, 1103 Budapest Gyömrői út 19-21 L-Ungerija
English: EU/1/12/750/001 EU/1/12/750/002 EU/1/12/750/003 EU/1/12/750/004 EU/1/12/750/005
Maltese: EU/1/12/750/001 EU/1/12/750/002 EU/1/12/750/003 EU/1/12/750/004
English: Date of first authorisation: 23 February 2012 Date of latest renewal: 14 November 2016
Maltese: Data tal-aħħar tiġdid: 14 ta' Novembru 2016
English: 28 tablets 30 tablets 84 tablets
Maltese: 28 pillola 30 pillola 84 pillola
English: ATC code: G03XB02.
Maltese: G03XB02.
English: Pack of 28, 30 and 84 tablets.
Maltese: Pakkett ta' 28, 30 u 84 pillola.
English: EU/1/12/750/001 28 tablets EU/1/12/750/002 84 tablets EU/1/12/750/003 30 tablets EU/1/12/750/004 28 tablets EU/1/12/750/005 84 tablets
Maltese: EU/1/12/750/001 28 pillola EU/1/12/750/002 84 pillola EU/1/12/750/003 30 pillola EU/1/12/750/004 28 pillola EU/1/12/750/005 84 pillola
English: 17, Rue de Pontoise FR-95520 Osny France
Maltese: 17, Rue de Pontoise FR-95520
English: 17 rue de Pontoise F-95520 Osny France
Maltese: 17 rue de Pontoise F-95520
English: clarithromycin, erythromycin, rifabutin).
Maltese: clarithromycin, erythromycin, rifbutin).
English: Patients in amenorrhea b,c
Maltese: Pazjenti f'amenorrea b,c
English: System Organ Class
Maltese: Sistema tal-klassifika tal-organi
English: • the indications.
Maltese: • l-indikazzjonijiet.
English: Patients with controlled bleeding b,c, d
Maltese: Pazjent bi fsada kkontrollata b,c,d
English: Educational material for pathologists
Maltese: Materjal edukattiv għall-patoloġisti
English: Endometrium
Maltese: Endometriju
English: Manufacturer Cenexi
Maltese: Manifattur Cenexi
English: DATE
Maltese: DATA
English: ESMYA 5mg TABLETS
Maltese: ESMYA 5mg PILLOLI
English: - The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium, talc and magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, mannitol, croscarmellose sodium, talc u magnesium stearate.
English: Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid glycoprotein, high density lipoprotein and low density lipoprotein.
Maltese: Ulipristal acetate jeħel ħafna (>98%) mal-proteini tal-plażma, inkluż l-albumina, il-glikoproteina alpha-l-acid, il-lipoproteina b'densità għolja u l-lipoproteina b'densità baxxa.
English: Leuprorelin 3.75 mg/ month N=93
Maltese: Leuprorelin 3.75 mg/ xahar N=93
English: - Certain medicines used to treat epilepsy (e.g. phenytoin, fosphenytoin, phenobarbital,
Maltese: - Ċerti mediċini użati għall-kura tal-epilessija (eż. phenytoin, fosphenytoin, phenobarbital,
English: Alu/PVC/PE/PVDC or Alu/PVC/PVDC blister.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folja tal-Alu/PVC/PE/PVDC jew tal-Alu/PVC/PVDC.
English: Esmya 5 mg tablets Ulipristal acetate
Maltese: Esmya 5 mg pilloli Ulipristal acetate
English: Study 1 was double-blind placebo controlled.
Maltese: L-istudju 1 kien double blind kkontrollat bi plaċebo.
English: CYP3A4 inducers
Maltese: Indutturi ta' CYP3A4
English: Study 4 was a randomized, double-blind clinical study assessing ulipristal acetate 5 or 10 mg.
Maltese: Studju 4 kien studju kliniku, double-blind, randomizzat li jivvaluta ulipristal acetate 5 jew 10 mg.
English: In vitro data indicate that ulipristal acetate and its active metabolite do not inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, or induce CYP1A2 at clinically relevant concentrations.
Maltese: Dejta in vitro tindika li ulipristal acetate u l-metabolit attiv tiegħu ma jimpedixxux lil CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, u 3A4, jew jinduċu lil CYP1A2 f'konċentrazzjonijiet klinikament rilevanti.
English: Frequencies are defined as very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from available data).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (1/10), komuni (1/100 sa <1/10), mhux komuni (1/1,000 sa <1/100) rari (1/10,000 sa <1/1,000), rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: NA N=202 N=192
Maltese: NA N=199 N=191 NA N=202 N=192
English: It is available in Alu/PVC/PE/PVDC blisters in cartons containing 28, 30 and 84 tablets or Alu/PVC/PVDC blisters in cartons containing 28 and 84 tablets.
Maltese: Dan jiġi f'folji tal-Alu/PVC/PE/PVDC f'kaxex tal-kartun li fihom 28, 30 u 84 pillola jew f'folji talAlu/PVC/PVDC f'kaxex tal-kartun li fihom 28 u 84 pillola.
English: In vitro data indicate that ulipristal acetate and its active metabolite are not P-gp (ABCB1) substrates.
Maltese: Dejta in vitro tindika li ulipristal acetate u l-metabolit attiv tiegħu mhumiex substrati ta' P-gp (ABCB1).
English: • Educational material for pathologists which contains o Pathologist's guide o USB stick or CD ROM with images of digital specimens (digital library with high resolution images) o SmPC
Maltese: • Materjal edukattiv għal patoloġisti li fih o Gwida għall-patoloġisti o USB stick jew CD ROM bi stampi ta' kampjuni diġitali (librerija diġitali bi stampi ta' riżoluzzjoni għolja) o SmPC
English: Co-administration of moderate (e.g. erythromycin, grapefruit juice, verapamil) or potent (e.g. ketoconazole, ritonavir, nefazodone, itraconazole, telithromycin, clarithromycin) CYP3A4 inhibitors and ulipristal acetate is not recommended (see section 4.5).
Maltese: L-għoti ta' inibituri moderati (eż. erythromycin, meraq tal-grejpfrut, verapamil) jew qawwija (eż. ketoconazole, ritonavir, nefazodone, itraconazole, telithromycin, clarithromycin) ta' CYP3A4 flimkien ma' ulipristal acetate mhuwiex irrakkomandat (ara sezzjoni 4.5).
English: In vitro data indicate that this is predominantly mediated by the cytochrome P450 3A4 isoform (CYP3A4).
Maltese: Dejta in vitro tindika li dan huwa medjat prinċipalment milliżoforma 3A4 taċ-ċitokromju P450 (CYP3A4).
English: DD/MM/YYYY
Maltese: JJ/XX/SSSS
English: • fatigue, severe tiredness
Maltese: • għeja, għeja severa
English: • the differential diagnosis between PAEC, unopposed oestrogen and endometrial hyperplasia.
Maltese: • id-dijanjożi differenzjali bejn PAEC, estroġenu mhux oppost u iperplasija endometrijali.
English: In all Phase III studies including repeated intermittent treatment studies, a total of 7 cases of hyperplasia were observed out of 789 patients with adequate biopsies (0.89%).
Maltese: III kollha li jinkludu studji b'kuri intermittenti ripetuti, ġew osservati total ta' 7 każijiet ta' iperplażja minn 789 pazjent b'bijopsiji adegwata (0.89%).
English: Repeated intermittent treatment has been studied up to 4 intermittent courses.
Maltese: Il-kura intermittenti ripetuta fit-tul ġiet studjata sa 4 korsijiet ta' kura intermittenti.
English: 5 mg/day N=213
Maltese: 5 mg/kulj um N=213
English: Median PBAC at baseline
Maltese: PBAC medjan fillinja bażi
English: Potential for other medicinal products to affect ulipristal acetate:
Maltese: Il-potenzjal li prodotti mediċinali oħra jaffettwaw lil ulipristal acetate:
English: In study 4, 61.9% and 72.7% of patients were in amenorrhea at the end of both treatment course 1 and 2 combined (5 mg dose and 10 mg dose, respectively, p=0.032); 48.7 % and 60.5 % were in amenorrhea at the end of all four treatment courses combined (5 mg dose and 10 mg dose, respectively, p=0.027).
Maltese: Fi studju 4, 61.9% u 72.7% tal-pazjenti kienu f'amenorrea kemm fi tmiem il-kors ta' kura 1 kif ukoll 2 ikkombinati (doża ta' 5 mg u doża ta' 10 mg, rispettivament, p=0.032). 48.7% u 60.5% kienu f'amenorreja fl-aħħar tal-erba' korsijiet ta' kura kkombinati kollha (doża ta' 5 mg u doża ta' 10 mg, rispettivament, p=0.027).
English: Marketing Authorisation Holder Gedeon Richter Plc.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Gedeon Richter Plc.
English: At the end of treatment course 4, 158 (69.6%) subjects and 164 (74.5%) subjects were assessed as being in amenorrhea, in the 5 mg dose and 10 mg dose respectively (p=0.290).
Maltese: Fl-aħħar tal-kors ta' kura 4, 158 (69.6%) individwu u 164 (74.5%) individwu kienu evalwati bħala li kienu f'amenorreja, fid-doża ta' 5 mg u d-doża ta' 10 mg rispettivament (p=0.290).
English: - Certain medicines used to treat HIV infection (e.g. ritonavir, efavirenz, nevirapine).
Maltese: - Ċerti mediċini użati għall-kura ta' infezzjoni tal-HIV (eż. Ritonavir, efavirenz, nevirapine).