FrancophonIA/ELRC3.0 huggingface dataset:
English: For UPA-containing emergency contraceptive products (ellaOne) it is concluded that limited and inconclusive data suggest that there may be reduced efficacy of UPA with increased body weight in women.
Maltese: Għal prodotti kontraċettivi ta' emerġenza li fihom UPA (ellaOne), ġie konkluż li dejta limitata u inkonklużiva tissuġġerixxi li jaf ikun hemm tnaqqis fl-effikaċja ta' UPA b'żieda fil-piż tal-ġisem finnisa.
English: On 16 January 2014 the Swedish Agency sent a notification for a referral under Article 31 of directive 2001/83 EC regarding all emergency contraceptives containing LNG or UPA asking the CHMP to give its opinion on whether the marketing authorisations should be maintained, varied, suspended or withdrawn.
Maltese: Fis-16 ta' Jannar 2014, l-Aġenzija Svediża bagħtet notifika għal riferiment skont l-Artikolu 31 tadDirettiva 2001/83/KE dwar il-kontraċettivi ta' emerġenza kollha li fihom LNG jew UPA fejn talbet lisCHMP biex jagħti opinjoni dwar jekk għandhomx jinżammu, jiġu varjati, sospiżi jew irtirati lawtorizzazzjonijiet għat-tqegħid fis-suq.
English: excluded intake later than 72 hours after unprotected intercourse (i.e. off-label use of LNG) and women who had further acts of unprotected intercourse.
Maltese: Iż-żewġ meta-analiżijiet eskludew teħid aktar tard minn 72 siegħa wara kopulazzjoni mhux protetta (jiġifieri użu off-label ta' LNG) u n-nisa li kellhom atti ulterjuri ta' kopulazzjoni mhux protetta.
English: • The Committee reviewed all data from clinical studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs), on the efficacy of emergency contraceptive medicinal products containing LNG or UPA, in particular with regards to a possible effect of high weight/BMI of women.
Maltese: • Il-Kumitat irreveda d-dejta kollha mill-istudji kliniċi, id-dokumentazzjoni ppubblikata, lesperjenza wara t-tqegħid fis-suq, inkluż ir-risponsi sottomessi mid-detenturi talawtorizzazzjoni għat-tqegħid fis-suq (MAHs), dwar l-effikaċja tal-prodotti mediċinali kontraċettivi ta' emerġenza li fihom LNG jew UPA, b'mod partikolari fir-rigward tal-effett possibbli ta' piż/BMI għoli tan-nisa.
English: Benefit -risk balance
Maltese: Il-bilanċ bejn il-benefiċċji u r-riskji
English: While the analyses of data from the three randomised controlled trials in which 2,098 women received UPA indicate a weak effect of body weight or BMI on pregnancy rates, the open label study (n=1,241) indicated no such effect.
Maltese: Filwaqt li l-analiżijiet tad-dejta mill-provi kliniċi randomizzati fejn 2,098 mara rċevew UPA, jindikaw effett dgħajjef tal-piż tal-ġisem jew il-BMI fuq ir-rati ta' tqala, l-istudju b'tikketta mikxufa (n=1,241) ma indika l-ebda tali effett.
English: Further, the data of the two meta-analyses should be reflected in section 5.1 of the SmPC.
Maltese: Barra minn hekk, id-dejta tal-meta-analiżijiet għandha tiġi ppreżentata fis-sezzjoni 5.1 tal-SmPC.
English: Overall summary of the scientific evaluation of emergency contraceptives medicinal products containing levonorgestrel or ulipristal acetate
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali ta' kontraċettivi ta' emerġenza li fihom levonorgestrel jew ulipristal acetate
English: In the meta-analysis including the three WHO studies, primarily including African and Asian women, no trend for a reduced efficacy with increasing body weight/BMI was observed (Table 1).
Maltese: Fil-meta-analiżi li tinkludi t-tliet studji tad-WHO, li prinċipalment tinkludi nisa Afrikani u Ażjatiċi, ma ġiet osservata ebda xejra għal tnaqqis fl-effikaċja b'piż talġisem/BMI dejjem jiżdied (Tabella 1).
English: The CHMP concluded that a warning in section 4.4 of the SmPC is appropriate to indicate that limited and inconclusive data are present regarding a possible reduced efficacy in women with a high body weight/BMI and that in all women emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman's body weight or BMI.
Maltese: Is-CHMP ikkonkluda li twissija fis-sezzjoni 4.4 tal-SmPC hija xierqa biex tindika li hija preżenti dejta limitata u inkonklużiva fir-rigward ta' tnaqqis fl-effikaċja f'nisa b'piż tal-ġisem/BMI għoli u li fin-nisa kollha, għandha tittieħed kontraċezzjoni ta' emerġenza malajr kemm jista' jkun wara kopulazzjoni mhux protetta, irrispettivament mill-piż tal-ġisem jew il-BMI tan-nisa.
English: The CHMP reviewed all data from clinical studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs), on the efficacy of emergency contraceptive medicinal products containing LNG or UPA, in particular with regards to the relation of high weight/BMI of women.
Maltese: Is-CHMP irreveda d-dejta kollha mill-istudji kliniċi, id-dokumentazzjoni ppubblikata, l-esperjenza wara t-tqegħid fis-suq, inkluż ir-risponsi sottomessi mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs), dwar l-effikaċja tal-prodotti mediċinali kontraċettivi ta' emerġenza li fihom LNG jew UPA, b'mod partikolari fir-rigward tar-relazzjoni ta' piż/BMI għoli tan-nisa.
English: The product is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Maltese: Il-prodott huwa indikat għall-kontraċezzjoni ta' emerġenza fi żmien 120 siegħa (5 ijiem) ta' kopulazzjoni sesswali mhux protetta jew nuqqas kontraċettiv.
English: For LNG-containing emergency contraceptives overall it is concluded that there is limited and inconsistent data on the effect of high body weight/high BMI on the contraceptive efficacy.
Maltese: B'mod globali, għall-kontraċettivi ta' emerġenza li fihom LNG, ġie konkluż li hemm dejta limitata u dejta inkonsistenti fuq l-effett ta' piż tal-ġisem għoli/BMI għoli fuq l-effikaċja kontraċettiva.
English: The emergency contraceptives can be divided into levonorgestrel (LNG)- and ulipristal acetate (UPA)-containing emergency contraceptives and they act by inhibiting and/or delaying ovulation.
Maltese: Il-kontraċettivi ta' emerġenza jistgħu jinqasmu f'kontraċettivi ta' emerġenza li fihom levonorgestrel (LNG) u ulipristal acetate u jaġixxu billi jinibixxu u/jew idewwmu l-ovulazzjoni.
English: The data are currently too limited and therefore insufficiently precise to draw definite conclusions whether efficacy is negatively influenced by increased body weight and BMI; for instance for the obese category (BMI ≥30) three pregnancies were reported in the first analysis, and eleven pregnancies in the second.
Maltese: Fil-preżent, id-dejta hija wisq limitata u għalhekk mhijiex preċiża biżżejjed biex jinstiltu konklużjonijiet definittivi dwar jekk l-effikaċja hijiex influwenzata b'mod negattiv minn żieda fil-piż tal-ġisem u l-BMI; pereżempju għall-kategorija tal-obeżi (BMI>30) ġew irrapportati tliet tqaliet flewwel analiżi, u ħdax-il tqala fit-tieni.
English: Overall for of LNG-containing emergency contraceptives it is concluded that there is limited data on the effect of high body weight/high BMI on the contraceptive efficacy.
Maltese: B'mod globali, għal kontraċettivi ta' emerġenza li fihom LNG, ġie konkluż li hemm dejta limitata fuq l-effett ta' piż tal-ġisem għoli/BMI għoli fuq l-effikaċja kontraċettiva.
English: This summary was last updated in 10-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'10-2017.
English: The full EPAR for Nuwiq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Nuwiq.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Nuwiq.
English: Other information about Nuwiq
Maltese: Informazzjoni oħra dwar Nuwiq
English: It contains the active substance simoctocog alfa (human coagulation factor VIII).
Maltese: Dan fih is-sustanza attiva simoctocog alfa (fattur tal-koagulazzjoni VIII tal-bniedem).
English: Simoctocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Maltese: Simoctocog alfa hija magħmula permezz ta' metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': din magħmula minn ċelloli li ġiet introdotta fihom ġene (DNA) li tagħmilhom kapaċi jipproduċuha.
English: Treatment with Nuwiq was rated as ‘excellent' or ‘good' for 94% of bleeding episodes.
Maltese: Il-kura b'Nuwiq ġiet ikklassifikata bħala “eċċellenti”jew “tajba” f'94% tal-episodji tal-emorraġija.
English: Why is Nuwiq approved?
Maltese: Għaliex ġie approvat Nuwiq?
English: Nuwiq has been shown to be effective at preventing and treating bleeding episodes in three main studies involving 113 patients with haemophilia A.
Maltese: Nuwiq intwera li hu effettiv fil-prevenzjoni u fil-kura ta' episodji ta' emorraġija fi tliet studji ewlenin li involvew 113-il pazjent b'emofilja A.
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Maltese: Pazjenti bl-emofilja A għandhom nuqqas tal-fattur VIII, li jikkawża problemi fil-koagulazzjoni, bħal emorraġija fil-ġogi, fil-muskoli jew fl-organi interni.
English: What are the risks associated with Nuwiq?
Maltese: X'inhuma r-riskji assoċjati ma' Nuwiq?
English: Nuwiq is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Maltese: Nuwiq huwa mediċina li tintuża għall-kura u l-prevenzjoni ta' emorraġija f'pazjenti ta' kull età b'emofilja A (disturb ta' emorraġija li jintiret ikkawżat minn nuqqas tal-fattur VIII).
English: When used for treatment, bleeding episodes resolved in 81% of cases following one or two injections with Nuwiq.
Maltese: Meta ntuża għall-kura, episodji ta' emorraġija ġew solvuti f'81% tal-każijiet wara injezzjoni waħda jew tnejn b'Nuwiq.
English: The second study involved 32 patients aged 12 years and above who were given Nuwiq to prevent and treat bleeding events as well as to prevent bleeding during surgery.
Maltese: It-tieni studju involva 32 pazjent minn 12-il sena'l fuq li ngħataw Nuwiq biex jipprevjeni u jikkura avvenimenti ta' emorraġija kif ukoll biex jipprevjeni emorraġija waqt il-kirurġija.
English: The first study involved 22 patients aged 12 years and above, who were given Nuwiq for the treatment of bleeding episodes or to prevent bleeding during surgery.
Maltese: L-ewwel studju involva 22 pazjent minn 12-il sena 'l fuq, li ngħataw Nuwiq għall-kura ta' episodji ta' emorraġija jew għall-prevenzjoni ta' emorraġija waqt il-kirurġija.
English: There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Maltese: Hemm riskju li bil-mediċini tal-fattur VIII ċerti pazjenti jiżviluppaw inibituri (antikorpi) kontra lfattur VIII, li jikkawżaw lill-mediċina li tieqaf tkun effikaċi u dan jirriżulta f'telf tal-kontroll talemorraġija.
English: The active substance in Nuwiq, simoctocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Maltese: Is-sustanza attiva f'Nuwiq, is-simoctocog alfa, (fattur tal-koagulazzjoni VIII tal-bniedem), hija sustanza li tgħin lid-demm jagħqad.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nuwiq on 24 July 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Nuwiq fl-24 ta' Lulju 2014.
English: For the full list of all side effects and restrictions with Nuwiq, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Nuwiq, ara l-fuljett ta' tagħrif.
English: In the five surgeries that occurred during the study, Nuwiq was rated as excellent in preventing bleeding episodes for four surgeries and as moderate to prevent bleeding during one surgical intervention.
Maltese: Fil-ħames kirurġiji li seħħew waqt l-istudju, Nuwiq ġie kklassifikat bħala eċċellenti fil-prevenzjoni ta' episodji ta' emorraġija għal erba' kirurġiji u bħala moderat filprevenzjoni ta' emorraġija waqt intervent kirurġiku wieħed.
English: A total of 986 bleeding episodes were recorded, the majority of which resolved with one injection of Nuwiq.
Maltese: B'kollox, ġie rreġistrat 986 episodju ta' emorraġija, li l-maġġoranza tagħhom issolvew b'injezzjoni waħda ta' Nuwiq.
English: When used for the treatment of bleeding episodes, Nuwiq was mainly rated as ‘excellent' or ‘good' at treating major bleeding episodes and most bleeding episodes resolved following one or more injections of Nuwiq.
Maltese: Meta ntuża għall-kura ta' episodji ta' emorraġija, Nuwiq ġie primarjament ikklassifikat bħala “eċċellenti” jew “tajjeb” fil-kura ta' episodji ta' emorraġija maġġuri u ħafna mill-episodji ta' emorraġija ssolvew wara injezzjoni waħda jew iktar ta' Nuwiq.
English: Hypersensitivity (allergic) reactions have been reported with factor VIII medicines and may in some cases become severe.
Maltese: Ġew irrapportati reazzjonijiet ta' ipersensittività (reazzjonijiet allerġiċi) bil-mediċini tal-fattur VIII u f'ċerti każijiet dawn jistgħu jsiru severi.
English: The dose and duration of treatment depend on whether Nuwiq is used to treat or prevent bleeding, or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Maltese: Iddoża u frekwenza tal-kura jiddependu fuq jekk Nuwiq jintużax għall-kura jew għall-prevenzjoni ta' emorraġija, jew matul kirurġija, kif ukoll fuq il-livelli tal-fattur VIII tal-pazjent, is-severità tal-emofilja, il-firxa u l-post tal-emorraġija u l-kundizzjoni u l-piż tal-ġisem tal-pazjent.
English: When Nuwiq was used to prevent bleeding, an average of 0.34 bleeds per month was recorded for each child.
Maltese: Meta Nuwiq intuża biex jipprevjeni emorraġija, ġiet irreġistrata medja ta' 0.34 emorraġija kull xahar għal kull tifel u tifla.
English: Nuwiq is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Maltese: Nuwiq jiġi bħala trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għal injezzjoni ġol-vina.
English: The Agency decided that Nuwiq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: L-Aġenzija ddeċidiet li l-benefiċċji ta' Nuwiq huma akbar mir-riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: The Agency concluded that Nuwiq has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Maltese: L-Aġenzija kkonkludiet li Nuwiq wera li kien effikaċi fil-kura u fil-prevenzjoni ta' emorraġija f'pazjenti bl-emofilja A u għandu profil ta' sigurtà aċċettabbli.
English: For practical information about using Nuwiq, patients should read the package leaflet or contact their doctor or pharmacist.
Maltese: It-tielet studju involva 59 tifel u tifla ta' bejn is-sentejn u t-12-il sena.
English: Nuwiq is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Maltese: Nuwiq jintuża biex jikkoreġi d-defiċjenza tal-fattur VIII billi jissostitwixxi l-fattur VIII nieqes, u jagħti kontroll temporanju taddisturb tal-emorraġija.
English: Mylan S.A.S 117 Allée des Parcs 69800 Saint-Priest France
Maltese: Mylan S.A.S 117 Allée des Parcs 69800 Saint-Priest Franza
English: 200 hard capsules
Maltese: 200 kapsula iebsa
English: Dieselweg 25, 3752 LB Bunschoten The Netherlands
Maltese: Dieselweg 25, 3752 LB Bunschoten L-Olanda
English: The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)5- methylhexanoic acid].
Maltese: Is-sustanza attiva, pregabalin, hija gamma-aminobutyric acid analogue [(S) 3 (aminomethyl) 5 methylhexanoic acid].
English: The active substance is pregabalin.
Maltese: Is-sustanza attiva hi pregabalin.
English: Capsules content Hydroxylpropylcellulose Maize starch Talc
Maltese: Kontenut tal-kapsuli Hydroxylpropylcellulose Maize starch Talc
English: McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland
Maltese: McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 L-Irlanda
English: Capsules shell Iron oxide yellow (E172) Titanium dioxide (E171) Erythrosine (E127) Gelatin
Maltese: Qoxra tal-kapsuli Iron oxide yellow (E172) Titanium dioxide (E171) Erythrosine (E127) Ġelatina
English: QT prolongation, sinus tachycardia, sinus arrhythmia
Maltese: Titwil tal-perijodu QT, sinus tachycardia, sinus arrhythmia
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Mylan Hungary Kft Mylan utca 1, Komárom, 2900, Hungary
Maltese: Mylan Hungary Kft Mylan utca 1, Komárom, 2900, L-Ungerija
English: Each hard capsule contains either 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg jew 300 mg pregabalin.
English: • Vertigo, problems with balance, fall
Maltese: • Vertigo, problemi fil-bilanċ, waqgħat
English: Ammonia solution, concentrated Potassium hydroxide
Maltese: Soluzzjoni ta' ammonia, konċentrata Potassium hydroxide
English: The other ingredients are: hydroxylpropylcellulose, maize starch, talc, gelatin, titanium dioxide (E171), sodium laurilsulfate, black ink (which contains shellac, black iron oxide (E172), macrogol, potassium hydroxide and concentrated ammonia solution), yellow iron oxide (E172) and erythrosine (E127).
Maltese: Is-sustanzi l-oħra huma: hydroxylpropylcellulose, maize starch, talc, ġelatina, titanium dioxide (E171), sodium laurilsulfate, linka sewda (li fiha shellac, black iron oxide (E172), macrogol, potassium hydroxide u soluzzjoni ta' ammonia konċentrata), yellow iron oxide (E172) u erythrosine (E127).
English: Creatinine clearance (CLcr) (ml/min)
Maltese: Tneħħija talkrejatinina (CLcr) (ml/min)
English: Vertigo Hyperacusis
Maltese: Hyperacusis
English: Pregabalin oral bioavailability is estimated to be ≥ 90% and is independent of dose.
Maltese: Il-bijodisponibilità orali ta' pregabalin hija stmata għal ≥90% u hija indipendenti mid-doża.
English: White blood cell count decreased * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Maltese: *Żieda fl-alanine aminotransferase (ALT) u żieda fl-aspartate aminotransferase (AST)
English: Epilepsy
Maltese: Epilessija
English: Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated funduscopic examination) was conducted in over 3600 patients within controlled clinical trials.
Maltese: Testijiet oftalmoloġiċi (inklużi testijiet fuq akutezza viżiva, ittestjar formali tal-kamp viżiv u eżaminazzjoni ta' dilatar funduskopiku) sar fi 3600 pazjent fi studji kliniċi kontrollati.
English: Paediatric population Pregabalin pharmacokinetics were evaluated in paediatric patients with epilepsy (age groups: 1 to 23 months, 2 to 6 years, 7 to 11 years and 12 to 16 years) at dose levels of 2.5, 5, 10 and 15 mg/kg/day in a pharmacokinetic and tolerability study.
Maltese: Il-farmakokinetika ta' pregabalin ġiet evalwata f'pazjenti pedjatriċi bl-epilessija (gruppi ta' età: xahar sa 23 xahar, sentejn sa 6 snin, 7 sa 11-il sena u 12 sa 16-il sena) f'livelli ta' doża ta' 2.5, 5, 10 u 15 mg/kg/jum fi studju dwar il-farmakokinetika u t-tollerabilità.
English: Uncommon Rare
Maltese: Rari ħafna
English: The percentage of subjects with at least a 50% reduction in partial onset seizures as compared to baseline was 40.6% of subjects treated with pregabalin 10 mg/kg/day (p=0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p=0.2600 versus placebo) and 22.6% of those receiving placebo.
Maltese: Il-persentaġġ ta' suġġetti li kellhom tal-inqas tnaqqis ta' 50% fl-aċċessjonijiet ta' bidu parzjali kkomparat mal-linja bażi kien ta' 40.6% mis-suġġetti kkurati bi pregabalin 10mg/kg/jum (p=0.0068 kontra il-placebo), 29.1% ta' suġġetti kkurati bi pregabalin 2.5mg/kg/jum (p=0.2600 kontra il-plaċebo) u 22.6% ta' dawk li kienu qed jircievu l-plaċebo.
English: In vivo studies and population pharmacokinetic analysis Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.
Maltese: Studji in vivo u analiżi farmakokinetika tal-popolazzjoni F'dan ir-rigward, fi studji in vivo ma kienu osservati ebda interazzjonijiet farmakokinetiċi klinikament rilevanti bejn pregabalin u phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone jew ethanol.
English: Maximum dose (mg/day)
Maltese: Doża massima (mg/ġurnata)
English: Pregabalin mean elimination half-life is 6.3 hours.
Maltese: Il-half life medja ta' l-eliminazzjoni ta' pregabalin hija 6.3 sigħat.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 June 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25 Ġunju, 2015
English: Central nervous system influencing medical products Pregabalin may potentiate the effects of ethanol and lorazepam.
Maltese: Prodotti mediċinali li jinfluwenzaw is-sistema nervuża ċentrali Pregabalin jista' jżid l-effetti ta' ethanol u lorazepam.
English: Pregabalin pharmacokinetics in patients younger than 3 months old have not been studied (see sections 4.2, 4.8 and 5.1).
Maltese: Il-farmakokinetika ta' pregabalin f'pazjenti iżgħar minn 3 xhur ma ġietx studjata (ara sezzjonijiet 4.2, 4.8 u 5.1).
English: Inter-subject pharmacokinetic variability for pregabalin is low (<20%).
Maltese: Ilvarjabilità fil-farmakokinetika bejn persuna u oħra għal pregabalin hija baxxa (<20%).
English: Oral contraceptives, norethisterone and/or ethinyl oestradiol Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.
Maltese: Kontraċettivi orali norethisterone u/jew ethinyl oestradiol L-amministrazzjoni ta' pregabalin mal-kontraċettivi orali norethisterone u/jew ethinyl oestradiol ma tinfluwenzax il-farmakokinetika stabbli ta' xi waħda mis-sustanzi.
English: In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (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), not known (cannot be estimated from the available data)).
Maltese: F'tabella 2 ta' hawn isfel ir-reazzjonijiet avversi kollha, li seħħew b'inċidenza akbar mill-plaċebo u f'aktar minn pazjent wieħed, huma elenkati bil-klassi u l-frekwenza (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) mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Gastrointestinal disorders Common
Maltese: Disturbi gastro-intestinali Komuni
English: The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) with partial onset seizures were similar to those observed in adults.
Maltese: L-avvenimenti avversi osservati fi studju farmakokinetiku u studju dwar it-tollerabilità, li rregistraw pazjenti li kellhom minn 3 xhur sa 16-il sena (n=65) b'aċċessjonijiet ta' bidu parzjali kienu simili għal dawk osservati fl-adulti.