FrancophonIA/ELRC3.0 huggingface dataset:
English: -1 Cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain: 2,500 - 8,000 PFU*
Maltese: -1 Vajrus tal-herpes rikombinanti attiv tad-dundjani assoċjat maċ-ċelloli (rHVT/ND) li jesprimi l-proteina ta' fużjoni tal-istrejn lentoġeniku tal-vajrus D-26 tal-mard Newcastle:
English: EU (MA) Number
Maltese: Numru tal-UE Isem kummerċja li
English: Benepali etanercept
Maltese: Benepali etanersept
English: The full EPAR and risk management plan summary for Benepali 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: 78% of patients given Benepali (193 out of 247) achieved at least a 20% reduction in ACR scores after 24 weeks of treatment, compared with 80% of patients given Enbrel (188 out of 234).
Maltese: Ir-riżultati ta' dan l-istudju wrew li Benepali huwa effettiv daqs Enbrel biex inaqqas is-sintomi tal-artrite rewmatojde: 78% tal-pazjenti li ngħataw Benepali (193 minn 247) laħqu mill-inqas tnaqqis ta' 20% fil-punteġġi ACR wara 24 ġimgħa ta' kura, meta mqabbla ma' 80% ta' pazjenti li ngħataw Enbrel (188 minn 234).
English: The usual recommended dose is 50 mg once a week.
Maltese: Id-doża rakkomandata normalment hija ta' 50 mg darba fil-ġimgħa.
English: This is a summary of the European public assessment report (EPAR) for Benepali.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Benepali.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Benepali on 14 January 2016.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Benepali valida fl-Unjoni Ewropea kollha fl-14 ta' Jannar 2016.
English: Benepali is an anti-inflammatory medicine.
Maltese: Benepali huwa mediċina antiinfjammatorja.
English: Benepali contains the active substance etanercept and is a ‘biosimilar medicine'.
Maltese: Benepali fih is-sustanza attiva etanersept u huwa ‘mediċina bijosimili'.
English: Other information about Benepali
Maltese: Informazzjoni oħra dwar Benepali
English: The reference medicine for Benepali is Enbrel.
Maltese: Il-mediċina ta' referenza għal Benepali hi Enbrel.
English: Benepali was also compared with Enbrel in one main study involving 596 adult patients with moderate to severe rheumatoid arthritis despite treatment with methotrexate.
Maltese: Benepali tqabbel ukoll ma' Enbrel fi studju ewlieni li involva 596 pazjent b'artrite rewmatojde moderata sa severa minkejja l-kura b'metotressat.
English: • moderate to severe rheumatoid arthritis (an immune-system disease causing inflammation of the joints) in adults (aged 18 years or over).
Maltese: • artrite rewmatojde moderata sa severa (marda tas-sistema immunitarja li tikkawża infjammazzjoni fil-ġogi) f'adulti (minn 18-il sena 'l fuq).
English: The active substance in Benepali, etanercept, is a protein designed to block the activity of a protein in the body called tumour necrosis factor (TNF).
Maltese: Is-sustanza attiva f'Benepali, l-etanersept, hija proteina li tfasslet biex timblokka l-attività ta' proteina fil-ġisem magħrufa bħala fattur tan-nekrożi tumorali (TNF, tumour necrosis factor).
English: The most common side effects with Benepali are injection-site reactions (including bleeding, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections).
Maltese: L-effetti sekondarji l-aktar komuni b'Benepali huma reazzjonijiet fis-sit tal-injezzjoni (inkluż dmija, ħmura, ħakk, uġigħ u nefħa), u infezzjonijiet (inkluż irjiħat, u infezzjonijiet fil-pulmun, fil-bużżieqa talawrina u fil-ġilda).
English: • severe non-radiographic axial spondyloarthritis (a chronic inflammatory disease of the spine) when there are objective signs of inflammation but no abnormalities seen on x-ray;
Maltese: • spondiloartrite aksjali mhux radjografika severa (marda infjammatorja kronika tal-ispina) meta jkun hemm sinjali oġġettivi ta' infjammazzjoni iżda l-ebda anormalità ma tidher fuq ir-raġġi x;
English: Why is Benepali approved?
Maltese: Għaliex ġie approvat Benepali?
English: Benepali is not for use in children weighing less than 62.5 kg, as Benepali does not have low-dose formulations.
Maltese: Benepali mhuwiex għall-użu fit-tfal li jiżnu inqas minn 62.5kg, peress li Benepali ma jkollux formulazzjonijiet ta' doża baxxa.
English: A study was carried out to show that Benepali produces similar levels of the active substance in the body to Enbrel.
Maltese: Sar studju sabiex juri li Benepali jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħal Enbrel.
English: Laboratory studies comparing Benepali with Enbrel have shown that the active substance in Benepali is highly similar to that in Enbrel in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorju li jqabblu Benepali ma' Enbrel urew li s-sustanza attiva f'Benepali hija simili ħafna għal fik f'Enbrel f'termini ta' struttura, purità u attività bijoloġika.
English: What are the risks associated with Benepali?
Maltese: X'inhuma r-riskji assoċjati ma' Benepali?
English: This means that Benepali is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Benepali huwa simili ħafna għal mediċina bijoloġika (magħrufa wkoll bħala l-‘mediċina ta' referenza') li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: The educational materials also include a reminder that Benepali is not for use in children and adolescents who weigh less than 62.5 kg.
Maltese: Il-materjali edukattivi jinkludu wkoll tfakkira li Benepali mhuwiex għall-użu fit-tfal u fladoloxxenti li jiżnu inqas minn 62.5kg.
English: − adolescents aged 12 to 17 years who have psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) and who have not responded adequately to or cannot take methotrexate;
Maltese: − adolexxenti li għandhom bejn 12 u 17-il sena li jkollhom artrite psorjatika (marda li tikkawża rqajja' ħomor, bil-qoxra fuq il-ġilda u infjammazzjoni tal-ġogi) u li ma jkunux irrispondew b'mod adegwat għall-metotressat jew li ma jistgħux jiħduh;
English: − adolescents aged 12 to 17 years who have enthesitis-related arthritis and have not responded adequately to or cannot take standard treatment;
Maltese: − adolexxenti li għandhom bejn 12 u 17-il sena li jkollhom artrite relatat mal-enteżiti u li ma jkunux irrispondew b'mod adegwat għall-kura standard jew li ma jistgħux jiħduha;
English: The main measure of effectiveness was the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 24 weeks of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-proporzjon ta' pazjenti li kisbu mill-inqas tnaqqis ta' 20% fil-punteġġi ACR (kejl tal-ġogi li jikkawżaw l-uġigħ u li huma minfuħin u sintomi oħrajn) wara 24 ġimgħa ta' kura.
English: • psoriatic arthritis in adults who have not responded adequately to other treatments;
Maltese: • artrite psorjatika f'adulti li ma jkunux irrispondew b'mod adegwat għal kuri oħra;
English: Patients who take Benepali must be given the special alert card that summarises important safety information about the medicine so they can recognise any serious side effects and know when to seek urgent attention from their doctor.
Maltese: Il-pazjenti li jieħdu Benepali għandhom jingħataw il-kard ta' twissija speċjali li tiġbor fil-qosor l-informazzjoni importanti dwar is-sigurtà tal-mediċina sabiex ikunu jistgħu jagħrfu xi effetti sekondarji serji u jkunu jafu meta għandhom ifittxu l-attenzjoni urġenti tattabib tagħhom.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Benepali has a highly similar structure, purity and biological activity to Enbrel and is distributed in the body in the same way.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Benepali għandu struttura, purità u attività bijoloġika simili ħafna għal Enbrel u jiġi distribwit bl-istess mod fil-ġisem.
English: By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Maltese: Billi timblokka t-TNF, l-etanersept tnaqqas l-infjammazzjoni u sintomi oħrajn tal-mard.
English: Benepali is used either in combination with methotrexate (a medicine that acts on the immune system) in adults with moderate or severe disease who have not responded adequately to other treatments, or on its own if methotrexate is not suitable for the patient.
Maltese: Benepali jintuża f'kombinazzjoni ma' metotressat (mediċina li taġixxi fuq is-sistema immunitarja) f'adulti morda b'mod moderat jew sever jew li ma jkunux irrispondew b'mod adegwat għal kuri oħrajn, jew waħdu jekk il-metotressat ma jkunx jaqbel mal-pazjent.
English: • severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) who have not responded adequately to other treatments;
Maltese: • spondilite ankilosanti severa (marda li tikkawża infjammazzjoni tal-ġogi tal-ispina) f'adulti li ma jkunux irrispondew b'mod adegwat għal kuri oħra;
English: • certain forms of juvenile idiopathic arthritis (a rare childhood disease causing inflammation of joints) in the following groups:
Maltese: • ċerti forom tal-artrite idjopatika ġuvenili (marda rari li tfeġġ fit-tfulija li tikkawża infjammazzjoni ta' ħafna ġogi) fil-gruppi li ġejjin:
English: • plaque psoriasis (a disease causing red, scaly patches on the skin) with moderate to severe disease in adults and in patients from the age of six years with long-term severe disease.
Maltese: • psorijażi bil-qoxra (marda li tikkawża rqajja' ħomor bil-qoxra fuq il-ġilda) bil-marda moderata sa severa f'adulti morda moderatament sa serjament u f'pazjenti minn sitt snin 'il fuq li jkollhom marda severa fit-tul.
English: − patients aged two to 17 years with disease that affects many joints (polyarthritis which is rheumatoid-factor-positive or -negative) and disease that starts in a few joints and then extends to many (oligoarthritis) and have not responded adequately to or cannot take methotrexate;
Maltese: − pazjenti li għandhom bejn sentejn u 17-il sena bil-marda li taffettwa ħafna ġogi (poliartrite pożittiva jew negattiva għall-fattur rewmatojde) u l-marda li tibda fi ftit ġogi u mbagħad tiġi estiża għal ħafna (oligoartrite) u li ma jkunux irrispondew b'mod adegwat għall-metotressat jew li ma jistgħux jiħduh.
English: Thus, all these data were considered sufficient to conclude that Benepali will behave in the same way in terms of effectiveness in adults as in children in Benepali's approved indications.
Maltese: Għaldaqstant, din id-data kollha tqieset suffiċjenti biex jiġi konkluż li Benepali se jaġixxi bl-istess mod f'termini ta' effikaċja fl-adulti kif ukoll fit-tfal fl-indikazzjonijiet approvati ta' Benepali.
English: How does Benepali work?
Maltese: Kif jintuża Benepali?
English: Therefore, the CHMP's view was that, as for Enbrel, the benefits outweighs the identified risks.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Enbrel, il-benefiċċju huwa akbar mir-riskji identifikati.
English: 20 February 2013 EMA/796016/2012 rev.1
Maltese: 20 ta' Frar 2013 EMA/796016/2012 rev.1
English: • Tygacil: 30 November 2012
Maltese: • Tygacil: 30 ta' Novembru 2012
English: • Fenofibrato Pensa and Fenofibrato Ranbaxy: 20 February 2013
Maltese: • Fenofibrato Pensa u Fenofibrato Ranbaxy: 20 ta' Frar 2013
English: Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V.
Maltese: Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva u Ribavirin Teva Pharma B.V.
English: For more information, see: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/07/WC500130159.pdf
Maltese: Għal aktar tagħrif, ara: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/07/WC500130159.pdf globali ppreżentata fl-applikazzjonijiet.
English: • Ribavirin Teva and Ribavirin Teva Pharma B.V., generic medicines containing ribavirin, used for the treatment of hepatitis C (a disease of the liver due to an infection with the hepatitis C virus); 1 Procedure numbers: EMEA/H/C/001018/A-20/0008, EMEA/H/C/001064/A-20/0007, EMEA/H/C/000229/A-20/0060, EMEA/H/C/000644/A-20/0072, EMEA/H/A-31/001340.
Maltese: 1 Numri tal-Proċeduri: EMEA/H/C/001018/A-20/0008, EMEA/H/C/001064/A-20/0007, EMEA/H/C/000229/A-20/0060, EMEA/H/C/000644/A-20/0072, EMEA/H/A-31/001340.
English: • Temodal: 26 November 2012
Maltese: • Temodal: 26 ta' Novembru 2012
English: Outcome of four procedures under Article 20 of Regulation (EC) No 726/2004 and of one procedure under Article 31 of Directive 2001/83/EC as amended
Maltese: Eżitu ta' erba' proċeduri skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 u ta' proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE kif emendat1
English: • Ribavirin Teva Pharma B.V: 06 December 2012
Maltese: • Ribavirin Teva Pharma B.V: 06 ta' Diċembru 2012
English: The studies concerned were all conducted at the Cetero Research facility in Houston, Texas, USA.
Maltese: L-istudji kkonċernati saru kollha fil-faċilità tar-Riċerka Cetero fi Houston, Texas, fl-Istati Uniti tal-Amerika.
English: More information on these medicines can be found on the EMA website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Aktar tagħrif dwar dawn il-mediċini jinstab fuq is-sit elettroniku tal-EMA: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • Ribavirin Teva: 06 December 2012
Maltese: • Ribavirin Teva:06 ta' Diċembru 2012
English: • Leflunomide Apotex and associated names: 30 November 2012
Maltese: • Leflunomide Apotex u ismijiet assoċjati: 30 ta' Novembru 2012
English: • Leflunomide Actavis and Leflunomide Apotex, generic medicines containing the active substance leflunomide, used for the treatment of rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints).
Maltese: • Leflunomide Actavis u Leflunomide Apotex, mediċini ġeneriċi li fihom is-sustanza attiva leflunomide, użati għall-kura tal-artrite rewmatika (marda tas-sistema immunitarja li tikkawża ħsara u infjammazzjoni fil-ġogi).
English: • Temodal, anticancer medicine containing temozolomide, used for the treatment of malignant glioma (brain tumours);
Maltese: • Temodal, mediċina ta' kontra l-kanċer li fiha temozolomide, użata għall-kura ta' glijoma malinna
English: • Cilazapril Teva and associated names: 10 December 2012
Maltese: • Cilazapril Teva u ismijiet assoċjati: 10 ta' Diċembru 2012
English: • Fenofibrato Pensa and Fenofibrato Ranbaxy, generic medicines containing fenofibrate, used to control the levels of cholesterol and other lipids (fats) in the blood;
Maltese: • Fenofibrato Pensa u Fenofibrato Ranbaxy, mediċini ġeneriċi li fihom fenofibrate, użati għall-kontroll tal-livelli ta' kolesterol u lipidi (xaħmijiet) oħrajn fid-demm;
English: • Leflunomide Actavis and associated names: 30 November 2012
Maltese: • Leflunomide Actavis u ismijiet assoċjati: 30 ta' Novembru 2012
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that for seven medicines (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V.) some of the studies that supported their authorisation could not be considered reliable.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li għal seba' mediċini (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva u Ribavirin Teva Pharma B.V.) xi wħud mill-istudji li kienu jappoġġjaw lawtorizzazzjoni tagħhom ma setgħux jitqiesu affidabbli.
English: • Tygacil, an antibiotic containing tigecycline, used for the treatment of complicated infections of the skin and soft tissue (the tissue below the skin), and complicated infections in the abdomen.
Maltese: • Tygacil, antibijotiku li fih tigecycline, użat għall-kura ta' infezzjonijiet ikkumplikati fil-ġilda u fit tessut artab (it-tessut ta' taħt il-ġilda), u infezzjonijiet ikkumplikati fl-addome.
English: In July 2012, the CHMP had concluded a similar review for three other concerned centrally authorised medicines: Conbriza, PecFent and Torisel.3
Maltese: F'Lulju 2012, is-CHMP kien temm reviżjoni simili għal tliet mediċini oħrajn ikkonċernati awtorizzati skont il-proċedura ċentrali: Conbriza, PecFent u Torisel.
English: The EMA was made aware that recent inspections of the Texas-based Cetero Research facility by the US Food and Drug Administration had raised concerns over the way laboratory analyses of certain studies, called ‘bio-analytical' studies, were conducted at this facility in the period from April 2005 to June 2010.
Maltese: L-EMA ġiet mgħarrfa li spezzjonijiet reċenti tal-faċilità tar-Riċerka Cetero li tinsab f'Texas millAmministrazzjoni Amerikana tal-Ikel u l-Mediċini kienu qajmu tħassib dwar il-mod kif saru l-analiżijiet fil-laboratorju ta' ċerti studji, imsejħa studji ‘bijoanalitiċi', f'din il-faċilità fil-perjodu bejn April 2005 u Ġunju 2010.
English: Hence, the results of the studies concerned could not be considered reliable.
Maltese: Għaldaqstant, ir-riżultati tal-istudji kkonċernati ma setgħux jitqiesu affidabbli.
English: On 20 September 2012, the European Medicines Agency completed a review of nine centrally and nationally authorised medicines2, following concerns over the conduct of laboratory analyses of certain studies submitted as part of their marketing authorisation applications.
Maltese: Fl-20 ta' Settembru 2012, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' disa' mediċini awtorizzati skont il-proċedura ċentrali u dik nazzjonali2, wara tħassib dwar kif saru ċerti analiżijiet fillaboratorju ta' ċerti studji ppreżentati bħala parti mill-applikazzjonijiet tagħhom għall-awtorizzazzjoni għat-tqegħid fis-suq.
English: For these generic medicines, the studies conducted at the Texas-based Cetero Research facility were bioequivalence studies, to demonstrate that they produce the same levels of the active substance in the body as their reference medicines.
Maltese: Fil-każ ta' dawn il-mediċini ġeneriċi, l-istudji li saru fil-faċilità tar-Riċerka Cetero li tinsab f'Texas kienu studji ta' bijoekwivalenza, sabiex juru li huma jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem bħall-mediċini ta' referenza tagħhom.
English: In July 2012, the CHMP had already completed a similar review of three other medicines (Conbriza, PecFent and Torisel) and concluded that there is no impact on the benefit-risk balance of these medicines and that the marketing authorisation should be maintained.
Maltese: F'Lulju 2012, is-CHMP kien diġà temm reviżjoni simili ta' tliet mediċini oħrajn (Conbriza, PecFent u Torisel) u kkonkluda li m'hemm l-ebda impatt fuq il-bilanċ bejn il-benefiċċju u r-riskju ta' dawn ilmediċini u li l-awtorizzazzjoni għat-tqegħid fis-suq għandha tinżamm.
English: Immediate Packaging
Maltese: Daqs tal-pakkett pillola waħda
English: Packaging Package size Withdrawal period
Maltese: Ippakkjar Daqs talpakkett
English: Pack size bottle (HDPE)
Maltese: Daqs talpakkett folja (PVC/PCTFE/alu) 112-ilpillola folja(PVC/PCTFE/alu) 120 pillola flixkun (HDPE)
English: Immediate Packaging
Maltese: 120 pillola
English: 90 (3x30) tablets
Maltese: 90 (3x30) pillola
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Maltese: Mnejn għandu jingħata Il-pakkett li jmiss mal-prodott
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: Date of last renewal: DDMMYY
Maltese: Data tal-aħħar tiġdid: DDMMYY
English: Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Hungary McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Maltese: Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, L-Ungerija McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, L-Irlanda
English: • Alcohol
Maltese: • Alkoħol
English: Elevated liver enzymes*
Maltese: Enzimi tal-fwied elevati* Suffejra
English: • Lorazepam - (used for treating anxiety)
Maltese: • Lorazepam - (użat għall-kura ta' ansjetà)
English: Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, The Netherlands Logiters, Logistica, Portugal, S.A., Estrada dos Arneiros, 4, Azambuja, 2050-544, Portugal For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Maltese: Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, L-Olanda Logiters, Logistica, Portugal, S.A., Estrada dos Arneiros, 4, Azambuja, 2050-544, Portugall
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,
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: • Oxycodone - (used as a pain-killer)
Maltese: • Oxycodone - (użat biex itaffi l-uġigħ)
English: White blood cell count decreased * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Maltese: Tnaqqis fl-għadd ta' ċelloli bojod tad-demm *Żieda fl-alanine aminotransferase (ALT) u żieda fl-aspartate aminotransferase (AST)
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: Pregabalin Mylan 25 mg hard capsules Pregabalin Mylan 50 mg hard capsules Pregabalin Mylan 75 mg hard capsules Pregabalin Mylan 100 mg hard capsules Pregabalin Mylan 150 mg hard capsules Pregabalin Mylan 200 mg hard capsules Pregabalin Mylan 225 mg hard capsules Pregabalin Mylan 300 mg hard capsules
Maltese: Pregabalin Mylan 25 mg kapsuli iebsin Pregabalin Mylan 50 mg kapsuli iebsin Pregabalin Mylan 75 mg kapsuli iebsin Pregabalin Mylan 100 mg kapsuli iebsin Pregabalin Mylan 150 mg kapsuli iebsin Pregabalin Mylan 200 mg kapsuli iebsin Pregabalin Mylan 225 mg kapsuli iebsin Pregabalin Mylan 300 mg kapsuli iebsin
English: Very rare: may affecr up to 1 in 10,000 people
Maltese: Rari Ħafna: jistgħu jaffettwaw sa persuna 1 minn kull 10,000