FrancophonIA/ELRC3.0 huggingface dataset:
English: • Adult women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth,
Maltese: • Nisa adulti li għaddejjin minn ovulazzjoni mgħaġla qabel l-użu ta' teknika ta' riproduzzjoni assistita bħall-fertiliżżazzjoni in vitro (IVF): Ovitrelle jittieħed biex iħeġġeġ maturazzjoni follikulari finali u lutejniżżazzjoni wara l-istimulazzjoni tat-tkabbir follikulari.
English: One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after the last administration of a follicle stimulating hormone (FSH) or human menopausal gonadotropin (hMG) preparation, i.e. when optimal stimulation of follicular growth is achieved.
Maltese: Siringa waħda mimlija għal-lest ta' Ovitrelle (250 mikrogrammi) tingħata 24 sa 48 siegħa wara l-aħħar somministrazjoni ta' ormon li jistimula l-follikuli (FSH) - jew preparazzjoni ta' gonadotropin menopawsali uman (hMG), i.e. meta l-istimulazzjoni ottimali tat-tkabbir follikulari tkun inkisbet.
English: Ovitrelle is a medicinal product of choriogonadotropin alfa produced by recombinant DNA techniques.
Maltese: Ovitrelle hu prodott mediċinali ta' choriogonadotropin alfa prodott minn teknika ta' DNA rikombinat.
English: • Malformations of sexual organs incompatible with pregnancy
Maltese: • Malformazzjoni ta' organi sesswali li ma jippermettux it-tqala
English: In anovulation, the risk of OHSS is increased by a serum estradiol level > 1500 pg/mL (5400 pmol/L) and more than 3 follicles of 14 mm or more in diameter.
Maltese: Waqt ovulazzjoni, ir-riskju ta' OHSS jiżdied b'livell ta' estradiol fisserum ta' > 1,500 pikogramma/millitru (5,400 pikomol/litru) u/jew aktar minn 3 follikuli ta' dijametru ta' 14 millimetru jew aktar.
English: One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after optimal stimulation of follicular growth is achieved.
Maltese: Siringa waħda mimlija għal-lest ta' Ovitrelle (250 mikrogrammi) tingħata 24 sa 48 siegħa wara li tinkiseb stimulazzjoni ottimali tat-tkabbir follikulari.
English: Paediatric population There is no relevant use of Ovitrelle in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' Ovitrelle fil-popolazzjoni pedjatrika.
English: • Local reactions at the injection site, such as pain, redness or swelling.
Maltese: • Reazzjonijiet lokali fis-sit tal-injezzjoni, bħal uġigħ, ħmura jew nefħa.
English: Clinical investigation in women for the indication of ART and anovulation was limited to one treatment cycle.
Maltese: Investigazzjoni klinika fuq in-nisa għallindikazzjoni ta' ART u għan-nuqqas ta' ovulazzjoni kienet limitata għal trattament ta' ċiklu wieħed.
English: Following intravenous administration, choriogonadotropin alfa is distributed to the extracellular fluid space with a distribution half-life of around 4.5 hours.
Maltese: Wara teħid minn ġol-vini, choriogonadotropin alfa jitqassam fl-ispazju fluwidu extra-ċellulari b'nofsħajja ta' distribuzzjoni ta' madwar 4.5 siegħa.
English: It shares the amino acid sequence with urinary hCG. Chorionic gonadotropin binds on the ovarian theca (and granulosa) cells to a transmembrane receptor shared with the luteinising hormone, the LH/CG receptor.
Maltese: Il- chorionic gonadotropin tingħaqqad fuq iċ-ċelloli theca (u granulosa) ta' l-ovarji ma' riċettur transmembraniku li hu wżat ukoll mill-ormon ta' lutejniżżazzjoni, ir-riċettur LH/CG.
English: Batch
Maltese: UŻU
English: To minimise the risk of OHSS, ultrasonographic assessments of follicular development and/or determination of serum estradiol levels should be performed prior to treatment and at regular intervals during treatment.
Maltese: Biex jitnaqqas ir-riskju ta' OHSS għandhom isiru evalwazzjonijiet ultrasonografiċi tal-iżvilupp follikulari u/jew għandha ssir determinazzjoni tal-livelli tal-estradiol tas-serum qabel il-kura u f'intervalli regolari matul il-kura.
English: • Ovarian, uterine or mammary carcinoma
Maltese: • Karċinoma fl-ovarji, fl-utru jew mammarja
English: It should be noted, however, that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Maltese: Madankollu għandu jiġi nnutat li t-tqala nnifisha kif ukoll l-OHSS, ukoll iġibu magħhom żieda fir-riskju ta' avvenimenti tromboemboliċi, bħal emboliżmu pulmonari, puplesija iskemika jew infart mijokardijaku.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains: 250 micrograms (6500 IU) of Choriogonadotropin alfa
Maltese: Kull siringa mimlija għal-lest fiha: 250 mikrogrammi (6,500 IU) ta' Choriogonadotropin alfa.
English: Interference with serum or urinary testing
Maltese: Interferenza mal-ittestjar tas-serum jew l-awrina
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 PRE-FILLED PEN
Maltese: L-aħjar li terġa' tpoġġiha lura fil-pakkett oriġinali.
English: • Discard the pen.
Maltese: • Armi l-pinna.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Maltese: Dan il- mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Ovitrelle is indicated in the treatment of
Maltese: Ovitrelle huwa indikat fil-kura ta'
English: Ovitrelle 250 micrograms/0.5 mL solution for injection in a pre-filled syringe Choriogonadotropin alfa
Maltese: Ovitrelle 250 mikrogrammi/0.5 millitru soluzzjoni għall-injezzjoni Choriogonadotropin alfa
English: Miscarriage
Maltese: Dijarea
English: Mild reversible skin reactions manifesting as rash Reproductive system and breast disorders Common:
Maltese: Reazzjonijiet riversibbli tal-ġilda, li jidhru bħala raxx Disturbi fis-sistema riproduttiva u fis-sider Komuni:
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Therefore, if signs of ovarian hyperstimulation occur such as serum estradiol level > 5,500 pg/mL (20,000 pmol/L) and/or when there are 30 or more follicles in total, it is recommended to withhold hCG administration and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Maltese: Għalhekk, jekk iseħħu sinjali ta' iperstimulazzjoni tal-ovarji bħal livell ta' estradiol fis-serum li jkun ta' >5,500 pikogrammi/millilitru (20,000 pikomol/litru) u/jew fejn hemm 30 follikulu jew aktar b'kollox, huwa rrakkomandat li jitwaqqaf it-teħid tal-hCG u li l-pazjenta tingħata l-parir li ma tagħmilx l-att sesswali jew li tuża metodi kontraċettivi li jostakola għal mill-inqas 4 ijiem.
English: When undergoing Assisted Reproductive Techniques, the risk of having a multiple pregnancy is related to the number of fertilised eggs or embryos placed inside you.
Maltese: Meta jkunu qed isirulek Tekniki ta' Riproduzzjoni Assistita, ir-riskju li jkollok tqala multipla jkun marbut man-numru ta' bajd fertilizzat jew embrijuni li jitpoġġew ġo fik.
English: Pack of 1 pre-filled pen and 1 injection needle.
Maltese: Pakkett ta' 1 pinna mimlija għal-lest u 1 labra ta' l-injezzjoni.
English: • Each pre-filled pen contains 250 micrograms choriogonadotropin alfa in 0.5 mL (equivalent to approximately 6,500 International Units, IU).
Maltese: Kull pinna mimlija għal-lest fiha 250 mikrogrammi ta' choriogonadotropin alfa f'0.5 millitru (ekwivalenti għal madwar 6,500 Unità Internazzjonali, IU).
English: Ovitrelle contains a medicine called ‘choriogonadotropin alfa', made in a laboratory by a special recombinant DNA technique.
Maltese: Ovitrelle fih mediċina msejħa ‘choriogonadotropin alfa', li ssir f'laboratorju minn teknika speċjali ta' DNA rikombinanti.
English: EXP
Maltese: WERREJ
English: A comparative study between the freeze-dried and the liquid formulation showed bioequivalence between the two formulations.
Maltese: Studju komparattiv bejn il-formulazzjoni friżata-niexfa li hi reġistrata preżentement u l-formulazzjoni likwida juri bio-ekwivalenza bejn iż-żewġ formulazzjonijiet.
English: • After the injection, dispose of the used needle safely, and discard the pen.
Maltese: • Wara l-injezzjoni, armi l-labra użata b'mod sigur, u armi l-pinna.
English: • This confirms that the dose has been fully delivered.
Maltese: • Iċċekkja d-data ta' skadenza fuq it-tikketta tal-pinna.
English: 3 mL cartridge (type I glass, with a bromobutyl rubber plunger stopper and an aluminium crimp cap with bromobutyl rubber) preassembled in a pre-filled pen.
Maltese: Skartoċċ ta' 3 mL (ħġieġ ta' tip I, b'tapp-planġer tal-lastku tal-bromobutyl u crimp cap b'lastku talbromobutyl) immuntat minn qabel f'pinna mimlija għal-lest.
English: • The other ingredients are mannitol, methionine, poloxamer 188, phosphoric acid, sodium hydroxide, water for injections.
Maltese: • Is-sustanzi mhux attivi l-oħra huma mannitol, methionine, poloxamer 188, phosphoric acid,
English: Subcutaneous use.
Maltese: Aħsel idejk.
English: In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events.
Maltese: F'nisa b'mard tromboemboliku riċenti jew li għadu għaddej jew nisa b'fatturi ta' riskju rikonoxxuti b'mod ġenerali għal avvenimenti tromboemboliċi, bħal storja medika personali jew tal-familja, il-kura b'gonadotropins tista' żżid b'mod addizzjonali r-riskju għal aggravament jew l-okkorrenza ta' dawn lavvenimenti.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 250 micrograms choriogonadotropin alfa* (equivalent to approximately 6,500 IU) in 0.5 mL solution.
Maltese: U KWANTITTATIVA Kull siringa mimlija għal-lest fiha 250 mikrogramma ta' choriogonadotropin alfa* (ekwivalenti għal madwar 6,500 IU) f'-0.
English: • The recommended dose is 1 pre-filled syringe (250 micrograms/0.5 mL) given as a single injection.
Maltese: • Id-doża rakkomandata hija ta' 1 siringa mimlija għal-lest (250 mikrogrammi/0.5 millitru)
English: Instructions For Use OVITRELLE 250 micrograms solution for injection in pre-filled pen Choriogonadotropin alfa
Maltese: Ovitrelle 250 mikrogrammi soluzzjoni għall-injezzjoni Choriogonadotropin alfa
English: • Allergic reactions such as fast or uneven pulse, swelling of your tongue and throat, sneezing, wheezing, or serious breathing difficulty are very rare (may affect up to 1 in 10,000 people).
Maltese: • Reazzjonijiet allerġiċi bħal rata tal-polz mgħaġla jew mhux regolari, nefħa f'ilsienek u lgerżuma, għatis, tħarħir, jew diffikultà serja biex tieħu n-nifs huma rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000).
English: * recombinant human chorionic gonadotropin, r-hCG produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Maltese: * gonadotropin korjoniku uman rikombinanti, r-hCG hu prodott permezz ta' teknoloġija ta' DNA rikombinanti f'ċelloli ta' l-ovarji tal-ħamster Ċiniż.
English: Each pre-filled pen contains 250 micrograms choriogonadotropin alfa* (equivalent to approximately 6,500 IU).
Maltese: Kull pinna mimlija għal-lest fiha 250 mikrogramma ta' choriogonadotropin alfa* (ekwivalenti għal madwar 6,500 IU).
English: Ovarian hyperstimulation syndrome may become a serious medical event characterised by large ovarian cysts, which are prone to rupture, weight gain, dyspnoea, oliguria or the presence of ascites within a clinical picture of circulatory dysfunction.
Maltese: Sindromu ta' stimulazzjoni eċċessiva tal-ovarji jista' jsir avveniment mediku serju karatteriżżat minn ċisti kbar fl-ovarji, li jistgħu jinfaqgħu, żieda fil-piż, qtugħ ta' nifs, oligurija jew il-preżenza ta' axxite fi ħdan sitwazzjoni klinika ta' funzjonament ċirkolatorju ħażin. OHSS sever jista' jkun ikkumplikat f'każijiet rari minn emoperitonew, problemi pulmonari akuti, torsjoni tal-ovarji, u tromboemboliżmu.
English: • if you have any condition that usually makes a normal pregnancy impossible, such as menopause or early menopause (ovarian failure), or malformations of sexual organs.
Maltese: • għandek xi kundizzjoni li normalment minħabba fiha tqala normali mhix possibbli, bħal menopawsa jew menopawsa bikrija (insuffiċjenza tal-ovarji), jew malformazzjonijiet tal-organi sesswali.
English: There is no clinical experience with Ovitrelle in the treatment of other conditions (such as corpus luteum insufficiency or male conditions); therefore, Ovitrelle is not indicated in these conditions.
Maltese: Ma hemm ebda esperjenza klinika b'Ovitrelle fil-kura ta' kundizzjonijiet oħrajn (bħal insuffiċjenza tal-corpus luteum jew kundizzjonijiet tal-irġiel); għaldaqstant, Ovitrelle mhuwiex indikat f'dawn ilkundizzjonijiet.
English: Uncommon: Severe OHSS, breast pain General disorders and administration site conditions Common:
Maltese: OHSS sever, uġigħ fis-sider Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni:
English: Dispose of all used items:
Maltese: Disturbi psikjatriċi Mhux komuni:
English: If you do a pregnancy test with serum or urine after use of Ovitrelle, and up to ten days later, it may happen that you get a false positive test result.
Maltese: Jekk tagħmel test tat-tqala bis-serum jew bl-awrina wara li tuża Ovitrelle, u sa għaxart ijiem wara, jista' jkun li tikseb riżultat ta' test pożittiv falz.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2)
English: Wipe the chosen area with an alcohol swab.
Maltese: Uża kull labra u pinna darba biss.
English: The incidence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Maltese: ART tista' tkun kemmxejn ogħla milli wara konċezzjonijiet spontanji.
English: Do not inject directly into a vein.
Maltese: mogħtija bħala injezzjoni waħda.
English: • if you have unexplained vaginal bleeding
Maltese: Ilma għall-injezzjonijiet
English: • The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and possible fluid accumulation in your stomach or chest.
Maltese: • L-OHSS jista' jsir sever b'ovarji li jikbru b'mod ċar, tnaqqis fil-produzzjoni tal-awrina, żieda fil-piż, diffikultà biex tieħu n-nifs u akkumulazzjoni possibbli ta' fluwidu fl-istonku jew fissider.
English: How to store Ovitrelle
Maltese: Mediċini oħra u Ovitrelle
English: • If you see a tiny drop(s) of fluid proceed to Section 4: Setting the dose to 250.
Maltese: • Jekk tara qatra/qtar żgħira/żgħar ta' fluwidu kompli minn Sezzjoni 4: Kif tissettja d-doża għal 250.
English: • The dose number shown in the dose display will turn back to ‘0'.
Maltese: • In-numru tad-doża muri fid-displej tad-doża se jmur lura għal 0.
English: • The recommended dose is 1 pre-filled pen (250 micrograms/0.5 mL) given as a single injection.
Maltese: • Id-doża rakkomandata hija ta' 1 pinna mimlija għal-lest (250 mikrogramma/0.5 mL) mogħtija bħala injezzjoni waħda.
English: For instructions on the administration with the pre-filled pen, see section 6.6 and the “Instructions for use” provided in the carton.
Maltese: Għal struzzjonijiet dwar l-għoti ta' pinna mimlija għal-lest, ara sezzjoni 6.6 u l-“Istruzzjonijiet għallużu” li hemm ipprovdut fil-kartuna.
English: “Instructions for use” provided in the carton.
Maltese: Ara l-“Istruzzjonijiet għall-użu” ipprovduti fil-kartuna.
English: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock Psychiatric disorders
Maltese: Reazzjonijiet ta' sensittività eċċessiva minn ħfief sa severi li jinkludu reazzjonijiet anafilattiċi u xokk
English: This could cause chest pain, breathlessness, stroke or heart attack (see also in section 2. under “Blood clotting problems”).
Maltese: Dan jista' jikkawża wġigħ fis-sider, qtugħ ta' nifs, puplesija jew attakk tal-qalb (ara wkoll f'sezzjoni 2 taħt “Problemi b'emboli taddemm”).
English: Pregnancy outside of the womb (an ectopic pregnancy) may occur in women with damaged fallopian tubes (the tubes which carry the egg from the ovary to the womb).
Maltese: Tqala 'l barra mill-utru (tqala ektopika) tista' sseħħ f'nisa b'tubi fallopjani difettużi (it-tubi li jġorru lbajda mill-ovarji għall-utru).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen contains 250 micrograms (approximately 6,500 IU) choriogonadotropin alfa
Maltese: Kull pinna mimlija għal-lest fiha 250 mikrogrammi (madwar 6,500 IU) ta' choriogonadotropin alfa.
English: • Feeling depressed, irritable or restless.
Maltese: • Tħossok dipressa, irritabbli jew bla kwiet.
English: • Anovulatory or oligo-ovulatory women:
Maltese: Injetta s-soluzzjoni immedjatament:
English: During Ovitrelle therapy, a minor thyroid stimulation is possible, of which the clinical relevance is unknown.
Maltese: Matul it-terapija permezz ta' Ovitrelle, hemm il-possibilità ta' stimulazzjoni żghira ta' tirojde, li tagħha r-relevanza klinika mhix magħrufa.
English: The rate of miscarriage, in both anovulatory patients and women undergoing assisted reproductive techniques, is higher than that found in the normal population but comparable with the rates observed in women with other fertility problems.
Maltese: Ir-rata ta' korriment, kemm f'pazjenti li ma jovulawx u f'nisa li fuqhom qed tintuża t-teknika ta' riproduzzjoni assistita, hi aktar għolja minn dik li tinstab fil-popolazzjoni normali iżda titqabbel marrati osservati fost nisa bi problemi oħra ta' fertilità.
English: • Anovulatory or oligo-ovulatory adult women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory women after stimulation of follicular growth.
Maltese: • Uġigħ fin-naħa t'isfel taż-żaqq flimkien ma' nawseja (tħossok imdardra) jew rimettar, jistgħu jkunu s-sintomi ta' Sindromu tal-Iperstimulazzjoni tal-Ovarji (OHSS).
English: In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Maltese: F'dawn in-nisa, il-benefiċċji tal-għoti ta' gonadotropin jeħtieġ li jiġu evalwati kontra rriskji.
English: * recombinant human chorionic gonadotropin, r-hCG produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Renal events
Maltese: Avvenimenti renali
English: UNIQUE IDENTIFIER -2D BARCODE
Maltese: IDENTIFIKATUR UNIKU -BARCODE 2D
English: Months 4, 5, 6
Maltese: Xahar 4, 5, 6
English: Difference in proportion (95% C.I.)
Maltese: Differenza fil-proporzjon (95 % C.I.)
English: --o-- Placebo + Allopurinol,
Maltese: --o-- Plaċebo + Allopurinol,
English: Name and address of the manufacturer responsible for batch release
Maltese: Name and address of the manufacturer responsible for batch release Grünenthal GmbH
English: Renal clearance is 25.6 mL/min (CV=56%).
Maltese: It-tneħħija renali hija 25.6 mL/min (CV=56 %).
English: CYP2B6 has not been studied in vivo.
Maltese: CYP2B6 ma ġiex studjat in vivo.
English: 6.1 List of excipients
Maltese: 6.1 Lista ta'eċċipjenti
English: Zurampic 200 mg vs. placebo
Maltese: Zurampic 200 mg vs. plaċebo
English: Oval, 5.7 x 12.9 mm, blue tablets.
Maltese: Pilloli blu, ta' 5.7 x 12.9 mm, ovali.
English: Epoxide hydrolase inhibitors
Maltese: Inibituri ta' epoxide hydrolase
English: Tablet core hypromellose microcrystalline cellulose lactose monohydrate crospovidone type A magnesium stearate
Maltese: Qalba tal-pillola hypromellose microcrystalline cellulose lactose monohydrate crospovidone tip A magnesium stearate
English: Clear (PVC/PVDC/Aluminium) blister of 10 or 14 (calendar blister) tablets.
Maltese: Folja (PVC/PVDC/Aluminju) ċara ta'10 jew 14-il pillola (folja kalendarja).
English: < PC: {number} SN: {number} NN: {number}>
Maltese: {numru} NN: {numru} >
English: Tablet coat hypromellose titanium dioxide triacetin
Maltese: Kisja tal-pillola hypromellose titanium dioxide triacetin
English: **Includes the preferred terms: renal failure, renal failure chronic and renal failure acute.
Maltese: ** Tinkludi t-termini ppreferuti: insuffiċjenza renali, insuffiċjenza renali kronika u insuffiċjenza renali akuta.
English: crospovidone, magnesium stearate - film-coating:hypromellose, titanium dioxide, triacetin, indigo carmine, brilliant blue FCF.
Maltese: - kisja tal-pillola: hypromellose (E464), titanium dioxide, triacetin, indigo carmine, brilliant blue FCF
English: Pack sizes of 10, 28, 30, 98 in non-perforated blisters.
Maltese: Daqsijiet tal-pakkett ta' 10, 28, 30, 98 f'folji mhux imtaqqbin.
English: *Photodermatosis, photosensitivity reaction, dermatitis allergic, pruritus and urticaria.
Maltese: Fotodermatożi, reazzjoni ta' fotosensittività, dermatite allerġika, ħakk u urtikarja.
English: Salicylates
Maltese: Saliċilati
English: Lesinurad is not an in vitro inhibitor of P-glycoprotein, BCRP, OATP1B3, MRP2, MRP4, OCT2, MATE1 and MATE2-K.
Maltese: Lesinurad mhuwiex inibitur in vitro tal-glikoproteina-P, BCRP, OATP1B3, MRP2, MRP4, OCT2, MATE1 u MATE2-K.
English: Mean (SE) Serum Uric Acid (mg/dL)
Maltese: Livelli medji (SE) ta' uric acid fis-serum (mg/dl)
English: Placebo + febuxostat 80 mg N=51
Maltese: Punt ta' żmien Plaċebo + febuxostat 80 mg N=51
English: Date of first authorisation: 18 February 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta' Frar 2016
English: Additionally, lesinurad led to a 6-8% decrease in International Normalised Ratio (INR) and Prothrombin Time (PT).
Maltese: Barra minn hekk, lesinurad wassal għal tnaqqis ta' 6-8% fil-Proporzjon Normalizzat Internazzjonali (INR) u l-Ħin tal-Prothrombin (PT).
English: In vitro, lesinurad is an inhibitor of CYP2C8, but not of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4 and mEH.
Maltese: In vitro, lesinurad huwa inibitur ta' CYP2C8, iżda mhux ta' CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4 u mEH.
English: Frequency categories are defined according to the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000) and very rare (<1/10,000).
Maltese: Ilkategoriji ta' frekwenza huma ddefiniti skont il-konvenzjonijiet li ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1000 sa < 1/100), rari (≥ 1/10000 sa < 1/1000) u rari ħafna (< 1/10,000).
English: Secondary hyperuricaemia
Maltese: Iperurikemija sekondarja
English: Zurampic 200 mg tablets lesinurad
Maltese: Zurampic 200 mg pilloli lesinurad
English: In vitro assessment of interactions
Maltese: Valutazzjonijiet in vitro tal-interazzjonijiet
English: The absolute bioavailability of lesinurad is approximately 100%.
Maltese: Il-bijodisponibbiltà assoluta ta' lesinurad hija ta' madwar 100 %.
English: Zieglerstraße 6
Maltese: Xahar 6
English: Excipient with known effect: Each tablet contains 52.92 mg of lactose (as monohydrate).
Maltese: Kull pillola fiha 52.92 mg ta' lactose (bħala monohydrate).
English: Based on population pharmacokinetic analysis, age, gender, race and ethnicity do not have a clinically meaningful effect on the pharmacokinetics of lesinurad.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, l-età, is-sess, ir-razza u l-etniċità ma għandhomx effett klinikament sinifikanti fuq il-farmakokinetika ta' lesinurad.
English: Acute gouty attacks (gout flares)
Maltese: Attakki akuti tal-gotta (irkadar tal-gotta)
English: Effects on serum uric acid and urinary excretion of uric acid In healthy subjects, lesinurad 200 mg lowered sUA levels and increased renal clearance and fractional excretion of uric acid.
Maltese: Effetti fuq uric acid fis-serum u l-eliminazzjoni urinarja ta' uric acid F'individwi b'saħħithom, lesinurad 200 mg naqqas il-livelli ta' sUA u żied l-eliminazzjoni mill-kliewi u l-eskrezzjoni frazzjonali tal-uric acid.