FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about Xeloda
Maltese: Informazzjoni oħra dwar Xeloda
English: The most common side effects with Xeloda are diarrhoea, nausea (feeling sick), vomiting, abdominal (belly) pain, stomatitis (sores in the mouth), palmar-plantar erythrodysaesthesia (hand-foot syndrome, a skin reaction with rash and pain on the hands and feet), tiredness, weakness, loss of appetite, problems due to formation of blood clots in the blood vessels, heart problems and kidney problems in patients who already have reduced kidney function.
Maltese: L-effetti sekondarji l-aktar komuni b'Xeloda huma dijarea, nawżja (tħossok ma' tiflaħx), rimettar, uġigħ addominali (fiż-żaqq), stomatite (selħiet fil-ħalq), eritrodisasteżija palmar-plantar (sindrome tas-saqajn u l-idejn, reazzjoni tal-ġilda b'raxx u wġigħ fl-idejn u fis-saqajn), għeja, dgħufija, nuqqas ta' aptit, problemi minħabba l-formazzjoni ta' emboli tad-demm fil-vażijiet, problemi tal-qalb, u problemi talkliewi f'pazjenti li diġà kellhom funzjoni tal-kliewi mnaqqsa.
English: Fluorouracil is very similar to pyrimidine.
Maltese: Il-fluworuraċil hija simili ħafna għall-pirimidina.
English: Xeloda contains the active substance capecitabine.
Maltese: Xeloda fih is-sustanza attiva kapeċitabina.
English: Treatment is continued for 6 months after colon surgery.
Maltese: Il-kura titkompla għal 6 xhur wara l-intervent kirurġiku fil-kolon.
English: • advanced gastric (stomach) cancer.
Maltese: • kanċer gastriku (tal-istonku) avvanzat.
English: What are the risks associated with Xeloda?
Maltese: X'inhuma r-riskji assoċjati ma' Xeloda?
English: Xeloda is taken as tablets, while fluorouracil normally needs to be injected.
Maltese: Xeloda jittieħed bħala pilloli, filwaqt li l-fluworuraċil normalment tkun trid tiġi injettata.
English: Xeloda (capecitabine)
Maltese: Kanċer tas-sider
English: Another study involving 1,886 patients who had had surgery showed that Xeloda together with oxaliplatin (another cancer medicine) was more effective than the combination of fluorouracil and folinic acid: patients taking Xeloda and oxaliplatin had 20% lower risk of getting cancer again or death compared with patients taking fluorouracil and folinic acid.
Maltese: Studju ieħor li involva 1,886 pazjent li kien sarilhom intervent kirurġiku wera li Xeloda flimkien maloksaliplatin (mediċina oħra kontra l-kanċer) kien aktar effettiv mit-taħlita tal-fluworuraċil u l-aċidu foliniku: il-pazjenti li kienu qed jieħdu Xeloda u oksaliplatin kellhom 20 % inqas riskju li jerġgħu jkollhom il-kanċer jew li jmutu meta mqabbla ma' pazjenti li kienu qed jieħdu l-fluworuraċil u l-aċidu foliniku.
English: Xeloda has also been compared with the combination of fluorouracil and folinic acid, both used in combination with oxaliplatin, in 2 studies: the first involved 2,035 patients who had not been treated before, and the second involved 627 patients in whom previous treatment with irinotecan and a fluoropyrimidine (a group of cancer medicines that includes fluorouracil) had not worked.
Maltese: Xeloda tqabbel ukoll mat-taħlita tal-fluworuraċil u l-aċidu foliniku, it-tnejn li huma jintużaw f'taħlita mal-oksaliplatin, f'2 studji: l-ewwel wieħed involva 2,035 pazjent li ma kinux ġew ikkurati qabel, u ttieni wieħed involva 627 pazjent li fuqhom il-kura preċedenti b'irinotekan u bi fluworopirimidina (grupp ta' mediċini kontra l-kanċer li jinkludi l-fluworuraċil) ma tkunx ħadmet.
English: Xeloda received a marketing authorisation valid throughout the EU on 2 February 2001.
Maltese: Xeloda ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-2 ta' Frar 2001.
English: In metastatic colorectal cancer, Xeloda taken on its own was as effective as the combination of fluorouracil and folinic acid in 2 studies involving 1,207 patients.
Maltese: Fil-kanċer kolorettali metastatiku, l-użu ta' Xeloda waħdu kien effettiv daqs it-taħlita tal-fluworuraċil u tal-aċidu foliniku f'2 studji li involvew 1,207 pazjenti.
English: Xeloda is used with docetaxel (another cancer medicine) after treatment with anthracyclines (another type of cancer medicine) has failed.
Maltese: Xeloda jintuża mad-doketaksel (mediċina oħra kontra l-kanċer) wara li l-kura bl-antraċiklini (tip ieħor ta' mediċina kontra l-kanċer) tkun falliet.
English: Xeloda has been shown to be effective in treating colon, colorectal, gastric and breast cancer.
Maltese: Intwera li Xeloda huwa effettiv fil-kura ta' kanċer tal-kolon, kanċer kolorettali, kanċer gastriku u kanċer tas-sider.
English: The safety profile of the medicine is considered acceptable.
Maltese: Il-profil tas-sigurtà tal-mediċina huwa kkunsidrat aċċettabbli.
English: The active substance in Xeloda, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Maltese: Is-sustanza attiva f'Xeloda, il-kapeċitabina, hija mediċina ċitotossika (mediċina li toqtol iċ-ċelloli li jkunu qegħdin jinqasmu, bħaċ-ċelloli tal-kanċer), li tagħmel parti mill-grupp tal-‘antimetaboliti'.
English: • patients who have had severe and unexpected reactions to fluoropyrimidine therapy;
Maltese: • f'pazjenti li kellhom reazzjonijiet severi u mhux mistennija għal terapija bi fluworopirimidina;
English: • colon (large bowel) cancer.
Maltese: • kanċer tal-kolon (musrana l-kbira).
English: In the body, fluorouracil takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Maltese: Fil-ġisem, il-fluworuraċil tissostitwixxi l-pirimidina u tinterferixxi mal-enzimi involuti filproduzzjoni ta' DNA ġdid.
English: Xeloda tablets should be taken within 30 minutes after a meal.
Maltese: Il-pilloli ta' Xeloda għandhom jittieħdu sa 30 minuta wara l-ikel.
English: Xeloda is used with other cancer medicines, including a platinum-containing cancer medicine such as cisplatin;
Maltese: Xeloda jintuża flimkien ma' medicini oħra kontra l-kanċer, inklużi mediċini kontra l-kanċer li jkun fihom il-platinu bħaċ-ċisplatina;
English: Also, the results of a published study involving 1,002 patients showed that patients taking combinations of medicines that included Xeloda survived for a similar period as those taking combinations that included fluorouracil.
Maltese: 1,002 pazjenti wrew li l-pazjenti li kienu qed jieħdu taħlitiet ta' mediċini li inkludew Xeloda ssopravivew għal perjodu simili għal dawk li kienu qed jieħdu t-taħlitiet li kienu jinkludu l-fluworuraċil.
English: Patients taking Xeloda with docetaxel had a longer time before the disease got worse compared with patients taking docetaxel on its own (186 days compared with 128 days).
Maltese: Il-pazjenti li kienu qed jieħdu doketaksel kellhom żmien itwal qabel ma l-marda qalbet għall-agħar meta mqabbla ma' pazjenti li kienu qed jieħdu doketaksel waħidha (186 jum meta mqabbla ma' 128 jum).
English: In colon cancer, Xeloda on its own has been shown to be as effective as the combination of fluorouracil and folinic acid (a medicine that enhances the effects of fluorouracil) in a main study involving 1,987 patients who had had surgery for their cancer.
Maltese: F'kanċer tal-kolon, intwera li Xeloda waħdu kien effettiv daqs it-taħlita tal-fluworuraċil u l-aċidu foliniku (mediċina li ttejjeb l-effetti tal-fluworuraċil) fi studju ewlieni li involva 1,987 pazjent li kien sarilhom intervent kirurġiku għall-kanċer tagħhom.
English: In advanced gastric cancer, Xeloda with cisplatin was as effective as a combination of fluorouracil and cisplatin in slowing down the disease in a study involving 316 patients.
Maltese: F'kanċer gastriku avvanzat, Xeloda maċ-ċisplatina kien effettiv daqs it-taħlita tal-fluworuraċil u ċċisplatina fit-trażżin tal-marda fi studju li involva 316-il pazjent.
English: How does Xeloda work?
Maltese: Kif jintuża Xeloda?
English: As for all medicines, data on the use of Xeloda are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Xeloda hija ssorveljata kontinwament.
English: Colon cancer
Maltese: Kanċer tal-kolon
English: Two smaller studies (238 patients) showed that Xeloda was effective after treatment with taxanes and anthracyclines did not work.
Maltese: Żewġ studji iżgħar (238 pazjent) urew li Xeloda kien effettiv wara l-kura b'tassani u l-antraċiklini ma ħadmux.
English: Xeloda is a cancer medicine that is used to treat:
Maltese: Xeloda huwa mediċina kontra l-kanċer li tintuża biex tikkura:
English: • patients with severe leucopenia, neutropenia, or thrombocytopenia (low levels of white cells or platelets in the blood);
Maltese: • f'pazjenti li jbatu minn forom serji ta' lewkopenija, newtropenija jew tromboċitopenija (livelli baxxi ta' ċelloli bojod jew ta' pjastrini fid-demm);
English: Xeloda is used on its own or with other cancer medicines in patients who have had surgery for stage III or Dukes' stage C colon cancer;
Maltese: Xeloda jintuża waħdu jew ma' mediċini oħra kontra l-kanċer fuq pazjenti li kien sarilhom intervent kirurġiku għal kanċer tal-kolon fil-fażi
English: How is Xeloda used?
Maltese: Kif jaħdem Xeloda?
English: For the full list of side effects reported with Xeloda, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Xeloda, ara l-fuljett ta' tagħrif.
English: Ref. EMEA/551181/2008
Maltese: EMEA/599103/2008
English: International non-proprietary name (INN): duloxetine
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): duloxetine
English: The companies that applied for authorisation are Eli Lilly Nederland B.V. (for Cymbalta) and Boehringer Ingelheim International GmbH (for Xeristar).
Maltese: Il-kumpaniji li applikaw għallawtorizzazzjoni huma Eli Lilly Nederland B.V. (għal Cymbalta) u Boehringer Ingelheim International GmbH (għal Xeristar).
English: • episodes of major depression;
Maltese: • episodji ta' dipressjoni maġġuri;
English: Cymbalta/Xeristar is a medicine containing the active substance duloxetine.
Maltese: Cymbalta/Xeristar huwa mediċina li fiha s-sustanza attiva duloxetine.
English: On 23 October 2008, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Cymbalta/Xeristar 30 mg and 60 mg gastroresistant capsules.
Maltese: Fit-23 ta' Ottubru 2008, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, fejn irrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Cymbalta/Xeristar 30 mg u 60 mg kapsuli gastroreżistenti.
English: Duloxetine, under the names Ariclaim and Yentreve, is also authorised for use in stress urinary incontinence.
Maltese: Duloxetine, bl-ismijiet Ariclaim u Yentreve, huwa awtorizzat ukoll sabiex jintuża f'inkontinenza urinarja taħt stress.
English: What is Cymbalta/Xeristar?
Maltese: X'inhu Cymbalta/Xeristar?
English: Cymbalta/Xeristar has been authorised since December 2004.
Maltese: Cymbalta/Xeristar ilu awtorizzat sa minn Diċembru 2004.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Maltese: • disturbi ta' ansjetà ġeneralizzati (ansjetà jew nervożiżmu fit-tul fuq kwistjonijiet ta' kuljum).
English: The results of five studies involving a total of 1,718 adults with fibromyalgia were presented to the CHMP to support the application.
Maltese: Ir-riżultati tal-ħames studji li jinvolvu total ta' 1,718-il adult b'fibromijalġija ġew ippreżentati lillCHMP biex jappoġġjaw l-applikazzjoni.
English: The active substance in Cymbalta/Xeristar, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Maltese: Is-sustanza attiva f'Cymbalta/Xeristar, duloxetine, hija inibitur ta' teħid mill-ġdid ta' serotoninnoradrenaline.
English: Four of the studies were short-term, lasting between three and six months, and comparing Cymbalta/Xeristar with placebo (a dummy treatment) in a total of 1,411
Maltese: Erbgħa mill-istudji kienu għal perjodu ta' żmien qasir, li damu bejn tliet u sitt xhur, u qabblu Cymbalta/Xeristar ma' plaċebo (kura finta) f'total ta' 1,411-il pazjent.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Maltese: • uġigħ dovut għal newropatija periferali dijabetika (ħsara għan-nervituri fl-estremitajiet li jistgħu jseħħu f'pazjenti b'dijabete);
English: In the short-term studies, the CHMP considered that the effect of Cymbalta/Xeristar was too small to be relevant for patients: there was no clear demonstration of improvement in symptoms, and the modest effects of Cymbalta/Xeristar could be due to the medicine's effect of improving the patients' mood.
Maltese: Fl-istudji b'perjodi ta' żmien qosra, is-CHMP qies li l-effett ta' Cymbalta/Xeristar kien żgħir wisq biex ikun relevanti għall-pazjenti: ma kien hemm ebda turija ċara tat-titjib fis-sintomi, u l-effetti modesti ta' Cymbalta/Xeristar setgħu kienu dovuti għall-effett tal-mediċina li ttejjeb ilburdata tal-pazjenti.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Maltese: Newrotrasmettituri huma kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Maltese: Jaħdem billi jimpedixxi lin-newrotrasmettituri 5-hydroxytryptamine (magħrufin ukoll bħala serotonin) u noradrenaline milli jittieħdu mill-ġdid lura miċ-ċelloli tan-nervituri fil-moħħ u filkorda spinali.
English: The CHMP was concerned that the effectiveness of Cymbalta/Xeristar in treating fibromyalgia had not been shown sufficiently.
Maltese: Is-CHMP kien imħasseb li l-effikaċja ta' Cymbalta/Xeristar ma ntwerietx b'mod konvinċenti fil-kura ta' fibromijalġija.
English: Cymbalta/Xeristar was also expected to be used to treat adults with fibromyalgia, a disease causing long-lasting, widespread pain and painful responses to touch.
Maltese: Cymbalta/Xeristar kien mistenni wkoll li jintuża biex jikkura adulti b'fibromijalġija, marda li tikkawża uġigħ li jdum u mifrux u risponsi b'uġigħ mal-mess.
English: The companies informed the CHMP that there are currently no ongoing clinical trials with Cymbalta/Xeristar in fibromyalgia patients in Europe.
Maltese: Il-kumpaniji għarrfu lis-CHMP li fil-preżent ma kien hemm ebda prova klinika għaddejja b' Cymbalta/Xeristar fuq pazjenti b'fibromijalġija fl-Ewropa.
English: What are the consequences of the refusal for patients in clinical trials with Cymbalta/Xeristar?
Maltese: Għal x'hiex kien mistenni li jintuża Cymbalta/Xeristar?
English: These were measured using standard scales and questionnaires.
Maltese: Dawn tkejlu skont miżuri u kwestjonarji standard.
English: The fifth, a long-term study, compared the effects of two doses of Cymbalta/Xeristar over a year in 307 patients.
Maltese: Il-ħames, studju fit-tul, qabbel l-effetti taż-żewġ dożi ta' Cymbalta/Xeristar fuq sena fi 307 pazjenti.
English: At that point in time, the CHMP was of the opinion that the benefits of Cymbalta/Xeristar in the treatment of fibromyalgia did not outweigh its risks.
Maltese: F'dak il-mument speċifiku, is-CHMP kien tal-opinjoni li l-benefiċċji Cymbalta/Xeristar fil-kura ta' fibromijalġija ma kinux jegħlbu r-riskji li kellu.
English: It is used for the treatment of adults with the following diseases:
Maltese: Jintuża għat-trattament ta' adulti bil-mard li ġej:
English: How is Cymbalta/Xeristar expected to work?
Maltese: Kif huwa mistenni li jaħdem Cymbalta/Xeristar?
English: The change concerned an extension of indication to add the treatment of fibromyalgia.
Maltese: Il-bidla kellha x'taqsam ma' estensjoni tal-indikazzjoni biex iżżid il-kura ta' fibromijalġija.
English: There are no consequences on the use of Cymbalta/Xeristar, Ariclaim or Yentreve in their authorised indications, for which the balance of benefits and risks remains unchanged.
Maltese: Ma hemm l-ebda konsegwenza fuq l-użu ta' Cymbalta/Xeristar, Ariclaim jew Yentreve fl-indikazzjonijiet awtorizzati tagħhom, fejn il-bilanċ bejn il-benefiċċji u r-riskji jibqa' kif kien.
English: 3.3 mg Powder for suspension for implantation
Maltese: 3.3 mg Trab għalsuspensjoni għallimpjantazzjoni
English: Intraosseous use Vial (glass)
Maltese: Għall-użu intrajossew kunjett (ħġieġ)
English: 1 vial l t o r
Maltese: 1 Kunjett t x
English: Invented name Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Isem ivvintat Qawwa Għamla farmaċewtika
English: Pregabalin Mylan Pharma is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Maltese: Pregabalin Mylan Pharma jiġi bħala kapsuli (25, 50, 75, 100, 150, 200, 225 u 300 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: The full EPAR for Pregabalin Mylan Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Pregabalin Mylan Pharma jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Pregabalin Mylan Pharma, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Maltese: Is-sustanza attiva f'Pregabalin Mylan Pharma, il-pregabalin, hija simili fl-istruttura għall-aċidu butriku tal-gamma-amino (GABA) ‘newrotrażmettitur' tal-ġisem stess, iżda għandu effetti bijoloġiċi differenti ħafna.
English: Pregabalin Mylan Pharma is a ‘generic medicine'.
Maltese: Pregabalin Mylan Pharma huwa ‘mediċina ġenerika'.
English: • epilepsy, where it is used as an ‘add-on' to other epilepsy treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain);
Maltese: • epilessija, fejn jintuża bħala "żieda" flimkien ma' kura eżistenti f'pazjenti li jbatu minn aċċessjonijiet parzjali (aċċessjonijiet epileptiċi li jibdew f'parti speċifika tal-moħħ);
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Mylan Pharma.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat mal-mediċina ta' referenza, Lyrica, u ma għandhomx għalfejn jiġu ripetuti għal Pregabalin Mylan Pharma.
English: Because Pregabalin Mylan Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Pregabalin Mylan Pharma huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Pregabalin Mylan Pharma contains the active substance pregabalin.
Maltese: Pregabalin Mylan Pharma fih is-sustanza attiva pregabalin.
English: Pregabalin Mylan Pharma pregabalin
Maltese: Informazzjoni oħra dwar Pregabalin Mylan Pharma
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Mylan Pharma.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pregabalin Mylan Pharma.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Mylan Pharma on 25 June 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pregabalin Mylan Pharma fil-25 ta' Ġunju 2015.
English: Why is Pregabalin Mylan Pharma approved?
Maltese: Għaliex ġie approvat Pregabalin Mylan Pharma?
English: For more information on generic medicines, see the questionand-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument ta ' mistoqsijiet u tweġibiet hawnhekk.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Mylan Pharma has been shown to have comparable quality and to be bioequivalent to Lyrica.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, skont irrekwiżiti tal-UE, intwera li Pregabalin Mylan Pharma għandu kwalità komparabbli u huwa bijoekwivalenti għal Lyrica.
English: What are the benefits and risks of Pregabalin Mylan Pharma?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Pregabalin Mylan Pharma?
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.
Maltese: Dan inaqqas l-attività ta' xi ċelloli tannervituri fil-moħħ u fis-sinsla tad-dahar, billi jnaqqas ir-rilaxx ta' newrotrażmettituri oħrajn li huma involuti fl-uġigħ, l-epilessija u l-ansjetà.
English: How has Pregabalin Mylan Pharma been studied?
Maltese: Kif ġie studjat Pregabalin Mylan Pharma?
English: The Committee recommended that Pregabalin Mylan Pharma be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Pregabalin Mylan Pharma jkun approvat għall-użu fl-UE.
English: How does Pregabalin Mylan Pharma work?
Maltese: Kif jintuża Pregabalin Mylan Pharma?
English: This means that Pregabalin Mylan Pharma contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Maltese: Dan ifisser li Pregabalin Mylan Pharma fih l-istess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) msejħa Lyrica.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Mylan Pharma have been included in the summary of product characteristics and the package leaflet.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u fil-fuljett ta' tagħrif ġew inklużi r-rakkomandazzjonijiet u lprekawzjonijiet li għandhom jiġu segwiti mill-professjonisti fil-qasam tal-kura tas-saħħa u mill-pazjenti għall-użu sigur u effettiv ta' Pregabalin Mylan Pharma.
English: Children (<40 kg) Indication
Maltese: Tfal (<40 kg) Indikazzjoni
English: 180 to 250 7.5 to 10
Maltese: 180 sa 250 7.5 sa 10
English: Spain - Nivador
Maltese: Spanja - Nivador
English: This will reduce the risk of any problems.
Maltese: Dan inaqqas ir-riskju ta' xi problemi.
English: 2.5 to 5 2 (250 mg) 1 (250 mg)
Maltese: 2.5 sa 5 2 (250 mg) 1 (250 mg)
English: S=susceptible, R=resistant
Maltese: S=suxxettibbli, R=reżistenti
English: • positive Coomb's test.
Maltese: • test ta' Coombs pożittiv.
English: • sinus
Maltese: • tas-sinus
English: Adults and children (≥40 kg)
Maltese: Adulti u tfal ( 40 kg)
English: Enterobacteriaceae 1, 2 Staphylococcus spp.
Maltese: Enterobacteriaceae 1, 2 L-ispeċijiet Staphylococcus
English: 40 to 60 6 months to 2 years 60 to 120 2.5 to 5 2 to 18 years
Maltese: 40 sa 60 6 xhur sa sentejn 60 sa 120 2.5 sa 5
English: Streptococcus pyogenes Streptococcus agalactiae Gram-negative aerobes:
Maltese: Streptococcus pyogenes Streptococcus agalactiae Aerobi negattivi għal Gram:
English: Staphylococcus aureus (methicillin susceptible)*
Maltese: Staphylococcus aureus (suxxettibbli għall-methicillin)*
English: Spain - Cefuroxima Solasma
Maltese: Spanja - Cefuroxima Solasma
English: Zinnat suspension contains sugar (sucrose).
Maltese: Is-suspensjoni ta' Zinnat fiha z-zokkor (sucrose).
English: Spain - Cefuroxima Allen
Maltese: Spanja - Cefuroxima Allen
English: haemolytic anaemia
Maltese: anemija emolitika
English: The following convention has been utilised for the classification of 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 and not known (cannot be estimated from the available data).
Maltese: Il-konvenzjoni li ġejja kienet utilizzata għall-klassifikazzjoni tal-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 u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: 2 Uncomplicated UTI (cystitis) only (see section 4.1).
Maltese: 2UTI mhux ikkumplikata (ċistite) biss (ara sezzjoni 4.1).