FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP concluded that, in accordance with EU requirements, Temomedac has been shown to have comparable quality and to be bioequivalent to Temodal.
Maltese: Is-CHMP kkonkluda li, b'konformità mar-rekwiżiti tal-UE, Temomedac wera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Temodal.
English: Temomedac is used to treat malignant glioma (brain tumours) in the following groups of patients:
Maltese: Temomedac jintuża biex ifejjaq il-glijoma malinna (tumuri fil-moħħ) fil-gruppi tal-pazjenti li ġejjin:
English: The active substance in Temomedac, temozolomide, belongs to a group of cancer medicines called alkylating agents.
Maltese: Is-sustanza attiva f'Temomedac, it-temożolomur, tappartjeni għal grupp ta' mediċini tal-kanċer li jissejħu aġenti alkilanti.
English: Why has Temomedac been approved?
Maltese: Għaliex ġie approvat Temomedac?
English: This means that Temomedac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Maltese: Dan ifisser li Temomedac huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Temodal.
English: Temomedac is a cancer medicine that contains the active substance temozolomide.
Maltese: Temomedac hu mediċina tal-kanċer li fiha s-sustanza attiva temożolomur.
English: Because Temomedac is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Maltese: Billi Temomedac huwa mediċina ġenerika, l-istudji ġew limitati għal testijiet biex jiddeterminaw ilbijoekwivalenza tiegħu mal-mediċina ta' referenza, Temodal.
English: Because Temomedac is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Maltese: Minħabba li Temomedac huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċju u r-riskju tiegħu huma meqjusa li huma analogi għal dawk tal-mediċina ta' referenza.
English: What is Temomedac?
Maltese: X'inhu Temomedac?
English: How does Temomedac work?
Maltese: Għal xiex jintuża Temomedac?
English: 1 vial + 1 filter needle
Maltese: 0.165 ml siringa mimlija għal-lest waħda kunjett wieħed + labra b'filtru waħda
English: Packaging Package size unit dose blister (PVC/PVDC/alu)
Maltese: strixxa b' doża waħda (PVC/PVDC/alu)
English: 100 x 1 tablet l t o r
Maltese: 100 x 1 pillola t x
English: EMEA Number
Maltese: Numru tal- EMA
English: Route of Administration
Maltese: Pakkett
English: 2 February 2016 EMA/822538/2015
Maltese: EMA/822538/2015
English: Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba
Maltese: Epilobium angustifolium L. u/jew Epilobium parviflorum Schreb., herba
English: It has no relevant use in patients under 18 years of age.
Maltese: M'għandhiex użu rilevanti f'pazjenti ta' inqas minn 18-il sena.
English: Further information on the HMPC assessment of willow herb medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with willow herb medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini li fihom iż-żafżafa, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' fil-websajt tal-Aġenzija:
English: What is willow herb?
Maltese: X'inhi żafżafa?
English: How are willow herb medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini li fihom iż-żafżafa?
English: Results from laboratory studies indicate that willow herb may have an effect on the growth of prostate cells as well as anti-inflammatory and pain-relieving activity.
Maltese: Ir-riżultati minn studji fi-laboratorju jindikaw li ż-żafżafa jista' jkollha effett fuq iż-żieda tan-numri taċ-ċelloli tal-prostata kif ukoll attività antiinfjammatorja u ta' serħan mill-uġigħ.
English: The HMPC concluded that, on the basis of its long-standing use, willow herb can be used by patients with benign prostatic hyperplasia (BPH) for the relief of lower urinary tract symptoms such as difficulty starting urination or a frequent need to urinate.
Maltese: BPH hija żieda mhux kanċeruża fid-daqs tal-glandola tal-prostata li ddawwar l-uretra, it-tubu li jġorr lawrina mill-bużżieqa tal-awrina 'l barra mill-ġisem.
English: What are the risks associated with willow herb medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini li fihom iż-żafżafa?
English: The HMPC conclusions on the use of willow herb medicines for the relief of lower urinary tract symptoms related to BPH are based on their ‘traditional use' in this condition.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu tal-mediċini li fihom iż-żafżafa għas-serħan tas-sintomi tal-kanal saflieni tal-awrina relatati mal-BPH huma bbażati fuq l-"użu tradizzjonali" tagħhom f'din il-kundizzjoni.
English: Any applications for the licensing of medicines containing willow herb have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom iż-żafżafa għandha titressaq lill-awtoritajiet nazzjonali responsabbli mill-prodotti mediċinali, li ser jivvalutaw l-applikazzjoni għall-mediċina talħxejjex u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: 14 July 2017 EMA/463868/2017
Maltese: 14 ta' Lulju 2017 EMA/463868/2017
English: The safety of the multiple sclerosis medicine Zinbryta is being reviewed.
Maltese: Is-sigurtà tal-mediċina tal-isklerożi multipla Zinbryta qed tiġi riveduta.
English: Zinbryta is a medicine used to treat adults with relapsing forms of multiple sclerosis.
Maltese: Zinbryta hija mediċina użata għall-kura ta' adulti b'forom rikaduti ta' sklerożi multipla.
English: • While on treatment with this medicine, you should contact your doctor immediately if you develop any symptoms of liver problems, such as unexplained nausea (feeling sick), vomiting, abdominal pain, tiredness, loss of appetite, yellowing of the skin and eyes and dark urine.
Maltese: • Waqt li tkun fuq il-kura b'din il-mediċina, int għandek tikkuntattja lit-tabib tiegħek immedjatament jekk tiżviluppa xi sintomi ta' problemi fil-fwied, bħal nawsja bla raġuni (tħossok ma tiflaħx), remettar, uġigħ addominali, għeja, nuqqas ta' aptit, sfurija tal-ġilda u tal-għajnejn u awrina skura.
English: • Treatment initiation is not recommended in patients with concurrent autoimmune conditions other than multiple sclerosis and in patients with serum transaminases (ALT or AST) that are at least twice the upper limit of normal (≥ 2 times the ULN).
Maltese: • Il-bidu tal-kura mhuwiex rakkomandat f'pazjenti b'kondizzjonijiet awtoimmuni konkurrenti minbarra l-isklerożi multipla u f'pazjenti bi transaminases fis-seru (ALT jew AST) li huma tal-inqas id-doppju tal-limitu massimu tan-normal (≥darbtejn l-ULN).
English: The review of Zinbryta has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-reviżjoni ta' Zinbryta nbdiet fuq talba tal-Kummissjoni Ewropea, skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004.
English: • Once the review of Zinbryta is concluded, further information will be provided.
Maltese: • Ladarba tiġi konkluża r-reviżjoni ta' Zinbryta, se tiġi pprovdut/a aktar informazzjoni.
English: This medicine was authorised in the EU in July 2016 to treat adults with relapsing forms of multiple sclerosis (a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord).
Maltese: Din il-mediċina ġiet awtorizzata fl-UE f'Lulju 2016 sabiex tikkura adulti b'forom rikaduti ta' sklerożi multipla (marda li fiha l-infjammazzjoni tagħmel ħsara lill-għata protettiva madwar iċ-ċelluli tannervituri fil-moħħ u fis-sinsla tad-dahar).
English: • As a precaution and while the review is ongoing, Zinbryta's use has been restricted to adult patients with highly active relapsing disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or with rapidly evolving severe relapsing multiple sclerosis who are unsuitable for treatment with other DMTs.
Maltese: • Bħala prekawzjoni u waqt li qiegħda ssir ir-reviżjoni, l-użu ta' Zinbryta ġie ristrett għal pazjenti adulti b'marda rikaduta attiva ħafna minkejja kors ta' kura sħiħ u adegwat b'tal-inqas terapija li timmodifika l-marda (DMT, disease modifying therapy) waħda jew bi sklerożi multipla rikaduta severa li tevolvi b'mod rapidu li mhumiex xierqa għal kura b'DMTs oħra.
English: These were forwarded to the European Commission (EC), which on 14 July 2017 issued a provisional legally binding decision applicable in all EU Members States.
Maltese: Dawn intbagħtu lill-Kummissjoni Ewropea (KE), li fl-14 ta' Lulju 2017 ħarġet deċiżjoni provviżorja legalment vinkolanti applikabbli fl-Istati Membri tal-UE kollha.
English: • Caution is recommended before giving Zinbryta in combination with medicinal products of known hepatotoxic potential, including non-prescription medicines and herbal supplements.
Maltese: • Hija rakkomandata l-kawtela qabel Zinbryta jingħata flimkien ma' prodotti mediċinali ta' potenzjal epatotossiku magħruf, inkluż mediċini li jinxtraw mingħajr riċetta u supplimenti erbali.
English: The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Maltese: L-istadju finali tal-proċedura ta' reviżjoni kien l-adozzjoni mill-Kummissjoni Ewropea ta' deċiżjoni legalment vinkolanti applikabbli fl-Istati Membri tal-UE kollha.
English: Relapsing means that the patient has flare-ups of the symptoms.
Maltese: Rikaduti tfisser li l-pazjent ikollu taħrix f'daqqa tas-sintomi.
English: EMA restricts use of multiple sclerosis medicine Zinbryta
Maltese: Aktar dwar il-mediċina
English: The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Maltese: Ir-reviżjoni qed issir mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC), ilKumitat responsabbli mill-valutazzjoni ta' kwistjonijiet tas-sigurtà għall-mediċini għall-użu millbniedem.
English: • Zinbryta treatment is not recommended in multiple sclerosis patients who have autoimmune diseases other than multiple sclerosis.
Maltese: • Il-kura b'Zinbryta mhijiex rakkomandata f'pazjenti bi sklerożi multipla li għandhom mard awtoimmuni ieħor minbarra l-isklerożi multipla.
English: Once the PRAC review is concluded, any further recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for evaluating medicines for human use, which will adopt a final opinion.
Maltese: Ladarba tiġi konkluża r-reviżjoni, kwalunkwe rakkomandazzjoni ulterjuri ser tintbagħat lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli mill-valutazzjoni tal-mediċini għall-użu mill-bniedem, li se jadotta opinjoni finali.
English: The European Medicines Agency (EMA) has provisionally restricted the use of the multiple sclerosis medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.
Maltese: L-Aġenzija Ewropea għall-Mediċini (EMA) rristrenġiet b'mod provviżorju l-użu tal-mediċina tal-isklerożi multipla Zinbryta (daclizumab) għal pazjenti b'marda rikaduta attiva ħafna li ma rrisponditx għal ċerta kura oħra, u għal pazjenti b'marda rikaduta li qed tevolvi b'mod rapidu li ma jistgħux jiġu kkurati b'mediċini oħra.
English: The risk of liver damage with the medicine was already known at time of its approval in the EU, and several measures were in place to manage this risk, including the requirement to monitor liver function and provide educational materials to healthcare professionals and patients on the risk of liver damage.
Maltese: Ir-riskju ta' ħsara fil-fwied bil-mediċina kien diġà magħruf meta ġie approvat fl-UE, u kien hemm diversi miżuri fis-seħħ sabiex jimmaniġġjaw dan ir-riskju, inkluż ir-rekwiżiti sabiex tiġi mmonitorjata l-funzjoni tal-fwied u sabiex jiġi pprovdut materjal edukattiv għall-professjonisti tal-kura tas-saħħa u għall-pazjenti dwar ir-riskju ta' ħsara fil-fwied.
English: Serum transaminase and bilirubin levels should be monitored at least monthly, and more frequently if clinically indicated, during treatment and for up to 4 months after the last dose.
Maltese: Il-livelli tattransaminase u tal-bilirubina fis-seru għandhom jiġu mmonitorjati tal-inqas kull xahar u b'mod aktar frekwenti jekk ikun indikat klinikament, waqt il-kura u sa 4 xhur wara l-aħħar doża.
English: • The use of Zinbryta has been restricted to patients with highly active relapsing disease that has failed to respond to other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.
Maltese: • Jekk ma jkunx inkiseb rispons terapewtiku adegwat, għandu jiġi kkunsidrat it-twaqqif tat-terapija.
English: Further information on Oprymea 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: It is available as immediate-release tablets (0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg and 1.1 mg) and prolonged-release tablets (0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg).
Maltese: Jiġi bħala pilloli b'rilaxx immedjat (0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg u 1.1 mg) u pilloli b'rilaxx fit-tul (0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg u 3.15 mg).
English: Oprymea is a ‘generic medicine'.
Maltese: Oprymea huwa “mediċina ġenerika”.
English: Other information about Oprymea
Maltese: Informazzjoni oħra dwar Oprymea
English: Oprymea received a marketing authorisation valid throughout the EU on 12 September 2008.
Maltese: Oprymea rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-12 ta' Settembru 2008.
English: Oprymea contains the active substance pramipexole.
Maltese: Oprymea fih is-sustanza attiva pramipeżol.
English: The active substance in Oprymea, pramipexole, is a dopamine agonist, which imitates the action of dopamine.
Maltese: Is-sustanza attiva f'Oprymea, il-pramipeżol, hija agonista tad-dopamina li timita l-azzjoni taddopamina.
English: • moderate to severe restless-legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Maltese: • sindromu tar-riġlejn bla mistrieħ (restless-legs syndrome) minn moderat għal gravi li huwa disturb li bih il-pazjent mhuwiex kapaċi jieqaf milli jċaqlaq riġlejh biex iwaqqaf sensazzjonijiet strambi, ta' skumdità jew ta' wġigħ fil-ġisem, normalment matul il-lejl.
English: Oprymea is a medicine used to treat the symptoms of the following diseases:
Maltese: Oprymea huwa mediċina użata fil-kura tas-sintomi tal-mard segwenti:
English: • Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Maltese: • Il-marda ta' Parkinson, disturb progressiv fil-moħħ li jikkawża rogħda, dewmien fil-movimenti u ebusija fil-muskoli.
English: Oprymea (pramipexole)
Maltese: Kif jintuża Oprymea?
English: This means that Oprymea contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Sifrol (also known as Mirapexin).
Maltese: Dan ifisser li Oprymea fih l-istess sustanza attiva u jaħdem blistess mod bħal “mediċina ta' referenza” diġà awtorizzata fl-UE imsejħa Sifrol (magħrufa wkoll bħala Mirapexin).
English: The recommended starting dose is one 0.088 mg tablet, but, if needed, this can be increased every four to seven days to reduce symptoms further, to a maximum of three 0.18 mg tablets.
Maltese: Id-doża inizjali rakkomandata hija ta' pillola ta' 0.088 mg, iżda jekk ikun meħtieġ din tista' tiżided kull erba' sa sebat ijiem sabiex is-sintomi jibqgħu jonqsu, sa massimu ta' tliet pilloli ta' 0.18 mg.
English: Because Oprymea 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: Minħabba li Oprymea huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: For Parkinson's disease, the starting dose is either one 0.088 mg immediate-release tablet three times a day or one 0.26 mg prolonged-release tablet once a day.
Maltese: Għall-marda ta' Parkinson, id-doża inizjali hija ta' pillola waħda b'rilaxx immedjat ta' 0.088 mg tliet darbiet kuljum jew pillola b'rilaxx fit-tul waħda ta' 0.26 mg darba kuljum.
English: The maximum daily dose for the immediate-release tablets is 1.1 mg three times a day and in case of the prolonged release tablets is 3.15 mg once a day.
Maltese: Id-doża massima li tista' tingħata fl-istess jum għall-pilloli b'rilaxx immedjat hija ta' 1.1 mg tliet darbiet kuljum filwaqt li fil-każ ta' pilloli b'rilaxx fit-tul id-doża massima hija ta' 3.15 mg darba kuljum.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Sifrol, and do not need to be repeated for Oprymea.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użi awtorizzati bil-mediċina ta' referenza, Sifrol, u ma għandhomx għalfejn jiġu ripetuti għal Oprymea.
English: The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated.
Maltese: Id-doża għandha tiżdied kull ħames sa sebat ijiem sakemm is-sintomi jiġu kkontrollati mingħajr ma jiġu kkawżati effetti sekondarji li ma jistgħux jiġu tollerati.
English: How has Oprymea been studied?
Maltese: Kif ġie studjat Oprymea?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Oprymea has been shown to have comparable quality and to be bioequivalent to Sifrol.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Oprymea wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Sifrol.
English: The syndrome is thought to be caused by problems in the way dopamine works in the brain, which can be corrected by pramipexole.
Maltese: Informazzjoni dwar il-mediċina ta' referenza tinstab ukoll fis-sit elettroniku tal-Aġenzija.
English: Oprymea must be given less frequently in patients who have problems with their kidneys.
Maltese: Oprymea għandu jingħata anqas frekwentement lil pazjenti li għandhom problemi fil-kliewi.
English: Oprymea can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective;
Maltese: Oprymea jista' jintuża jew waħdu jew flimkien ma' levodopa (mediċina oħra kontra l-marda ta' Parkinson) f'kull stadju tal-marda, anke fl-aħħar stadji meta levodopa tibda ssir inqas effettiva;
English: As for all medicines, data on the use of Oprymea are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Oprymea hija ssorveljata kontinwament.
English: De la Industria, 30,28108 Alcobendas, Madrid, Spain.
Maltese: De la Industria, 30, 28108 Alcobendas, Madrid, Spanja.
English: 3See section 4.4
Maltese: 3Ara sezzjoni 4.4
English: S.C.S.
Maltese: S.C
English: Excipients: sucrose 17.2 mg.
Maltese: Sustanzi mhux attivi: sucrose 17.2 mg.
English: Elevated liver enzymes (ALT, AST, alkaline phosphatase) Hepatitis3
Maltese: Enzimi talfwied għoljin (ALT, AST, alkaline phosphatase) Epatite3
English: • depression, anxiety and urinary incontinence.
Maltese: • depressjoni, ansjetà u inkontinenza awrinarja
English: Capsule content: hypromellose, Hypromellose Acetate Succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate.
Maltese: Kontenut tal-kapsula: hypromellose, hypromellose acetate succinate, sucrose, sferi taz-zokkor, talkum,titanium dioxide (E171), triethyl citrate.
English: Suicidal ideation 5 Suicidal5
Maltese: Formazzjoni ta' ideat suwiċidali5
English: Angio-neurotic oedema StevensJohnson Syndrome
Maltese: Edima anġjonewrotika Sindromu ta' StevensJohnson
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 8th October 2008
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI 8 ta' Ottubru 2008
English: Frequency estimate: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥ 1/10,000 and <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10), komuni (≥1/100 u <1/10), mhux komuni (≥1/1000 u <1/100), rari (≥1/10,000 u <1/1000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Tel.: + 42 02 34 65 51 11
Maltese: s r.o. Tel.: + 42 02 34 65 51 11
English: Use with antidepressants
Maltese: Użu ma' anti-depressivi
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 6828 patients, 4199 on duloxetine and 2629 on placebo).
Maltese: Tabella 1 turi r-reazzjonijiet avversi osservati minn rapporti spontanji u f'studji kliniċi kkontrollati bi plaċebo (b'total ta' 6828 pazjent, 4199 minnhom fuq duloxetine u 2629 fuq plaċebo).
English: Musculoskeletal and connective tissue disorders Musculoskeletal pain
Maltese: Disturbi muskolu-skeletrali u tal-connective tissue Uġigħ muskoluskeletali
English: Very common Common Uncommon
Maltese: Komuni Ħafna Komuni
English: Polyvinylchloride (PVC), Polyethylene (PE), and Polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminum foil.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Polyvinylchloride (PVC), Polyethylene (PE), u folja tal-polychlorotrifluoroethylene (PCTFE) issiġillata b'għatu tal-fojl ta' l-aluminju.
English: (See end of Section 2 for further information on sucrose) Capsule shell: gelatin, sodium lauryl sulphate, titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg).
Maltese: (Ara fl-aħħar ta' sezzjoni 2 għal aktar informazzjoni dwar sucrose) Il-Qoxra tal-kapsula: ġelatina, sodium lauryl sulphate, titanium dioxide (E171), indigo carmine (E132), iron oxide isfar (E172) (għas-60mg biss) u inkjostru aħdar li jittiekel (30mg) jew inkjostru abjad li jittiekel (60mg).
English: Hepatic impairment: moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Maltese: Indeboliment tal-fwied: mard moderat fil-fwied (Child Pugh Klassi B) affettwa l-farmakokinetika ta' duloxetine.
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with DULOXETINE BOEHRINGER INGELHEIM and 23% of patients taking placebo.
Maltese: F'provi kliniċi avvenimenti mhux mixtieqa b'sospensjoni tal-kura f'daqqa seħħew f'madwar 45% ta' pazjenti b'kura ta' DULOXETINE BOEHRINGER INGELHEIM u 23% ta' pazjenti jieħdu l-plaċebo.
English: Boehringer Ingelheim Comm.V.
Maltese: .S. Boehringer Ingelheim Comm.V.