FrancophonIA/ELRC3.0 huggingface dataset:
English: *A step-down statistical testing procedure was used in this study and this comparison was below a comparison that did not achieve statistical significance.
Maltese: * F'dan l-istudju intużat proċedura ta' ttestjar statistiku step-down u dan it-tqabbil kien anqas minn tqabbil li ma kisibx sinifikanza statistika.
English: An approximately 1.4-fold increase in umeclidinium bromide AUC was observed.
Maltese: Ġiet osservata żieda ta' madwar 1.4 darbiet fl-AUC ta' umeclidinium bromide.
English: France
Maltese: Deutschland
English: A greater improvement compared with placebo in the change from baseline in SGRQ total score at Week 24 was demonstrated for Rolufta Ellipta (-4.69 units, p<0.001∗) in the 24-week study.
Maltese: Titjib akbar meta mqabbel ma' plaċebo fil-bidla mil-linja bażi fil-punteġġ totali ta' SGRQ fil-Ġimgħa 24 intwera għal Rolufta Ellipta 55 mikrogramma (-4.69 unità p<0.
English: Your Rolufta Ellipta inhaler carton contains
Maltese: X'inhu Rolufta Ellipta u għalxiex jintuża
English: GSK Services Sp. z o.o.
Maltese: Informazzjoni għall-utent
English: Glaucoma
Maltese: Stitikezza
English: The instructions for use of the Ellipta inhaler provided below can be used for either the 30-dose inhaler (30 day supply) or the 7-dose inhaler (7 day supply).
Maltese: L-istruzzjonijiet li ġejjin għall-inalatur ta' 30 doża japplikaw ukoll għall-inalatur ta' 7 dożi.
English: B. PACKAGE LEAFLET
Maltese: MANIFATTUR(I) RESPONSABBLI
English: This leaflet
Maltese: Deskrizzjoni
English: Uncommon side effects
Maltese: Effetti sekondarji oħra
English: The European Medicines Agency has waived the obligation to submit the results of studies with Rolufta Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Maltese: Rolufta Ellipta f'kull sett tal-popolazzjoni pedjatrika f'COPD (ara sezzjoni 4.2 għal informazzjoni dwar l użu pedjatriku).
English: PC: SN: NN:
Maltese: PC:
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics, ATC code: R03BB07
Maltese: Mediċini għal mard ostruttiv tal-passaġġi tal-arja; Kodiċi ATC:
English: The absolute bioavailability of inhaled umeclidinium bromide was on average 13% of the dose, with negligible contribution from oral absorption.
Maltese: Il-bijodisponibilità assoluta ta' umeclidinium bromide man-nifs kienet bħala medja 13% tad-doża,
English: The Ellipta inhaler consists of a grey body, light green mouthpiece cover and a dose counter, packed into a foil laminate tray containing a desiccant packet.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih L-inalatur Ellipta jikkonsisti minn korp griż, għatu aħdar ċar tal-biċċa tal-ħalq u counter tad-dożi, ippakkjat fi trej laminat tal-fojl li fih pakkett ta' dessikant.
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: • irregular heart beat
Maltese: • taħbita irregolari tal-qalb
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Tray lid
Maltese: ANNESS IV
English: Annex A
Maltese: ANNESS A
English: 28 patches (7 x 2 mg/24h, 7 x 4 mg/24h, 7 x 6 mg/24h, 7 x 8 mg/24h)
Maltese: mg/24 siegħa, 7 x 4 mg/24 siegħa, 7 x 6 mg/24 siegħa, 7 x 8 mg/24 siegħa)
English: Transdermal patch Transdermal use sachet (paper/LDPE/alu/ET copolymer PE/Alu/ET copolymer/paper)
Maltese: Mnjen jingħata L-Ippakkeġġjar
English: PE/Alu/ ET copolymer/paper)
Maltese: Isem (Ivvintat)
English: The application was withdrawn at ‘day 180'.
Maltese: L-applikazzjoni ġiet irtirata fil-‘180 jum'.
English: It was to be available as capsules.
Maltese: Kien ser ikun disponibbli f'kapsuli.
English: 20 January 2009
Maltese: 20 ta' Jannar 2010
English: Diphenhydramine hydrochloride is an antihistamine.
Maltese: Diphenhydramine hydrochloride huwa antistamina.
English: How far into the evaluation was the application when it was withdrawn?
Maltese: Sa fejn kienet waslet l-evalwazzjoni tal-applikazzjoni qabel ma din ġiet irtirata?
English: Ibuprofen is a painkiller that belongs to the class non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Ibuprofen huwa analġesiku li jagħmel parti mill-klassi ta' mediċini mhux sterojdi kontra linfjammazzjoni (NSAIDs).
English: What is Ibuprofen/Diphenhydramine Hydrochloride Wyeth?
Maltese: X'inhu Ibuprofen/Diphenhydramine Hydrochloride Wyeth?
English: Ibuprofen/Diphenhydramine Hydrochloride Wyeth is a medicine that contains the active substances ibuprofen and diphenhydramine hydrochloride.
Maltese: Ibuprofen/Diphenhydramine Hydrochloride Wyeth hija mediċina li fiha s-sustanzi attivi ibuprofen u diphenhydramine hydrochloride.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Maltese: Dan ifisser li s-CHMP kien evalwa d-dokumentazzjoni pprovduta u fformula lista ta' mistoqsijiet.
English: It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation and pain.
Maltese: Huwa jaħdem billi jimblokka enzima msejħa cyclo-oxygenase, li tipproduċi lprostaglandini, sustanzi li huma involuti fl-infjammazzjoni u l-uġigħ.
English: The CHMP noted that the applicant had not shown enough evidence that there was a relevant advantage of using Ibuprofen/Diphenhydramine Hydrochloride Wyeth over using ibuprofen alone.
Maltese: Is-CHMP innota li l-applikant ma kienx wera biżżejjed evidenza li kien hemm vantaġġ rilevanti mill-użu ta' Ibuprofen/Diphenhydramine Hydrochloride Wyeth fuq l-użu ta' ibuprofen waħdu.
English: On 7 January 2010, Wyeth Consumer Healthcare officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth, for use in the treatment of mild to moderate pain in adults who are having difficulty sleeping because of the pain.
Maltese: Fis-7 ta' Jannar 2010, Wyeth Consumer Healthcare innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li hija tixtieq tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Ibuprofen/Diphenhydramine Hydrochloride Wyeth, għall-użu fit-trattament ta' uġigħ ħafif sa moderat fl-adulti li jkollhom diffikultà biex jorqdu minħabba l-uġigħ.
English: Diphenhydramine hydrochloride is found in medicines used to treat allergies, cough and sleep problems.
Maltese: Diphenhydramine hydrochloride jinsab fil-mediċini użati għat-trattament talallerġiji, sogħla u problemi ta' rqad.
English: The effects of Ibuprofen/Diphenhydramine Hydrochloride Wyeth were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Ibuprofen/Diphenhydramine Hydrochloride Wyeth għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq il-bniedem.
English: The company informed the CHMP that at present there are no ongoing clinical trials or compassionate use programmes with Ibuprofen/Diphenhydramine Hydrochloride Wyeth.
Maltese: Il-kumpanija għarrfet lis-CHMP li fil-preżent ma kienet qiegħda ssir l-ebda prova klinika jew programm ta' użu b'kumpassjoni b'Ibuprofen/Diphenhydramine Hydrochloride Wyeth.
English: Juluca (dolutegravir / rilpivirine)
Maltese: Juluca (dolutegravir / rilpivirina)
English: Further information on Juluca 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: • rifampicin, rifapentine (antibiotics);
Maltese: • rifampicin, rifapentine (antibijotiċi);
English: • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for epilepsy);
Maltese: • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (mediċini għall-epilessija);
English: • omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
Maltese: • omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (inibituri tal-pompa tal-proton għat-tnaqqis tal-aċidu fl-istonku);
English: Other information about Juluca
Maltese: Informazzjoni oħra dwar Juluca
English: Juluca is a HIV medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Juluca huwa mediċina kontra l-HIV li jintuża biex jikkura adulti infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindrome tal-immunodefiċjenza akkwiżita (AIDS).
English: The studies involved a total of 1,028 patients whose HIV infection was well controlled for at least 6 months on a combination of three HIV medicines that included a class of HIV medicines called nucleoside (or nucleotide) reverse transcriptase inhibitors (NRTIs).
Maltese: L-istudji involvew total ta' 1,028 pazjent li l-infezzjoni tal-HIV tagħhom kienet ikkontrollata tajjeb għal tal-inqas 6 xhur fuq kombinazzjoni ta' tliet mediċini kontra l-HIV li inkludiet klassi ta' mediċini kontra l-HIV imsejħa inibituri tat-traskriptażi inversa nukleosidiċi (jew nukleotidi) (NRTIs, nucleoside (or nucleotide) reverse transcriptase inhibitors).
English: • St John's wort (a herbal medicine used for treating depression).
Maltese: • St John's wort (preparazzjoni erbali li tintuża biex tikkura d-dipressjoni).
English: Dolutegravir, an integrase inhibitor, blocks an enzyme called integrase while rilpivirine, a non-nucleoside reverse-transcriptase inhibitor, blocks the activity of another enzyme called reverse transcriptase.
Maltese: Dolutegravir, inibitur ta' integrażi, timblokka enzima msejħa integrażi filwaqt li rilpivirina, inibitur tat-traskriptażi inversa mhux nukleosidiku, timblokka l-attività ta' enzima oħra msejħa traskriptażi inversa.
English: What are the risks associated with Juluca?
Maltese: X'inhuma r-riskji assoċjati ma' Juluca?
English: The active substances in Juluca are dolutegravir and rilpivirine.
Maltese: Is-sustanzi attivi f'Juluca huma dolutegravir u rilpivirina.
English: The proportion of patients whose viral load was below 50 copies/ml after 48 weeks was the same for patients switching compared with those remaining on the current medicines (95% in both cases).
Maltese: Il-proporzjon ta' pazjenti li t-tagħbija virali tagħhom kienet taħt 50 kopja/ml wara 48 ġimgħa kienet l-istess għall-pazjenti li qalbu meta mqabbel ma' dawk li baqgħu fuq il-mediċini attwali (95 % fiż-żewġ każijiet).
English: Both active substances are already available in the European Union: dolutegravir has been authorised since 2014 and rilpivirine has been authorised since 2011.
Maltese: Iż-żewġ sustanzi attivi diġà huma disponibbli fl-Unjoni Ewropea: dolutegravir ilha awtorizzata sa mill2014 u rilpivirina ilha awtorizzata sa mill-2011.
English: Two main studies found that the combination of dolutegravir and rilpivirine (the active substances in Juluca) was effective for keeping HIV infection under control.
Maltese: Żewġ studji ewlenin sabu li l-kombinazzjoni ta' dolutegravir u rilpivirina (is-sustanzi attivi f'Juluca) kienet effettiva biex iżżomm l-infezzjoni tal-HIV taħt kontroll.
English: Side effects reported with Juluca are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Juluca huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: • dexamethasone given by mouth or by injection (a steroid anti-inflammatory and immunosuppressant medicine) except when used as a single-dose treatment;
Maltese: • dexamethasone mogħti mill-ħalq jew permezz ta' injezzjoni (mediċina sterojde antiinfjammatorja u immunosoppressanti) ħlief meta jintuża bħala kura ta' doża waħda;
English: Because Juluca does not contain an NRTI, it is free of long-term side effects caused by NRTIs.
Maltese: Minħabba li Juluca ma fihx NRTI, dan m'għandux effetti sekondarji fit-tul ikkawżati mill-NRTIs.
English: The studies compared the effectiveness of switching to the combination of dolutegravir and rilpivirine with that of remaining on the current combination of HIV medicines.
Maltese: L-istudji qabblu l-effikaċja tal-qlib għall-kombinazzjoni ta' dolutegravir u rilpivirina ma' dik meta l-pazjent jibqa' fuq il-kombinazzjoni attwali ta' mediċini kontra l-HIV.
English: The European Medicines Agency considered that Juluca's effectiveness was comparable to that of combination treatment with three HIV medicines that include NRTIs.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkunsidrat li l-effikaċja ta' Juluca kienet komparabbli ma' dik talkura kombinata bi tliet mediċini kontra l-HIV li tinkludi NRTIs.
English: As for all medicines, data on the use of Juluca are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Juluca hija ssorveljata kontinwament.
English: Juluca is only used for patients whose levels of HIV-1 in the blood (viral load) have been below 50 copies/ml for at least 6 months on their current HIV treatment combination.
Maltese: Juluca jintuża biss għal pazjenti li l-livelli tagħhom ta' HIV-1 fid-demm (tagħbija virali) ilhom taħt 50 kopja/ml għal tal-inqas 6 xhur fuq il-kura kombinata attwali tagħhom kontra l-HIV.
English: The two active substances in Juluca, dolutegravir and rilpivirine, block the actions of enzymes that the HIV needs to make copies of itself in the cells it has infected.
Maltese: Iż-żewġ sustanzi attivi f'Juluca, dolutegravir u rilpivirina, jimblukkaw l-azzjonijiet tal-enzimi li teħtieġ lHIV biex tagħmel kopji tagħha fiċ-ċelloli li tkun infettat.
English: How is Juluca used?
Maltese: Kif jintuża Juluca?
English: For the full list of restrictions and side effects of Juluca, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet u l-effetti sekondarji ta' Juluca, ara l-fuljett ta' tagħrif.
English: • attenuated Chlamydophila felis (905 strain),
Maltese: • Chlamydophila felis (razza 905) attenwata,
English: • feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
Maltese: • virus tal-lewkimja felina (FeLV) virus tal-canarypox rikombinanti (vCP97).
English: • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
Maltese: • antiġeni tal-kaliċivirożi (razez FCV 431 u G1) inattivati (maqtula),
English: • attenuated feline panleucopenia virus (PLI IV),
Maltese: • virus tal-panlewkopenja felina (PLI IV) attenwat,
English: Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated), feline leukaemia and feline calicivirosis (inactivated) vaccine
Maltese: Tilqima tar-rinotrakeite virali felina, il-klamidjożi felina, il-panlewkopenja felina (ħajja attenwata), il-lewkimja felina u l-kaliċivirożi felina (inattivata)
English: The effectiveness of Purevax RCPCh FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, C. felis, parvovirus or leukaemia virus.
Maltese: L-effikaċja ta' Purevax RCPCh FeLV ġiet studjata f'diversi provi f'kundizzjonijiet ta' laboratorju fejn il-qtates tlaqqmu u ġew infettati b'virus tal-erpete, kaliċivirus, C. felis, parvovirus jew virus tal-lewkimja.
English: Purevax RCPCh FeLV is a veterinary vaccine that contains:
Maltese: Purevax RCPCh FeLV huwa tilqima veterinarja li fiha:
English: To protect against feline leukaemia, the vaccine contains two genes from the FeLV called env and gag, which have been inserted into another vector (carrier) virus called canarypox using ‘recombinant DNA technology'.
Maltese: Biex tipproteġi kontra l-lewkimja felina t-tilqima fiha żewġ ġeni mill-FeLV imsejħa env u gag, li ġew inseriti f'virus vettur (trasportatur) ieħor imsejjaħ canarypox li juża “teknoloġija tad-DNA rikombinanti”.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CVMP, aqra d-diskussjoni xjentifika (parti wkoll mill-EPAR).
English: The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.
Maltese: Il-viruses tal-canarypox ma jinfirxux jew jimmultiplikaw fil-qtates iżda jipproduċu proteini mill-ġeni tal-FeLV.
English: • feline leukaemia (an illness affecting the immune system caused by a retrovirus, feline leukaemia virus).
Maltese: • il-lewkimja felina (marda li taffettwa s-sistema immunitarja kkawżata minn retrovirus, il-virus tal-lewkimja felina).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh FeLV on 23 February 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Purevax RCPCh FeLV fit-23 ta' Frar 2005.
English: Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days.
Maltese: Xi drabi, il-qtates jiżviluppaw apatija temporanja (nuqqas ta' interess fl-ambjent ta' madwarhom) u anoressija (nuqqas ta' aptit) kif ukoll ipertermija (temperatura għolja tal-ġisem) li ddum jum jew tnejn.
English: • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
Maltese: • virus tal-erpete tar-rinotrakeite felina (razza FHV F2) attenwat (imdgħajjef),
English: Other information about Purevax RCPCh FeLV:
Maltese: Informazzjoni oħra dwar Purevax RCPCh FeLV:
English: • feline chlamydiosis (a flu-like illness caused by the bacterium C. felis),
Maltese: • il-klamidjożi felina (marda li tixbah l-influwenza kkawżata mill-batterju C. felis),
English: • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
Maltese: • ir-rinotrakeite virali felina (marda li tixbah l-influwenza kkawżata minn virus tal-erpete),
English: Purevax RCPCh FeLV is a vaccine.
Maltese: Purevax RCPCh FeLV huwa tilqima.
English: In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses.
Maltese: Fl-istudju fuq il-post tat-tilqim bażiku kien hemm żieda fl-antikorpi kontra l-virus tal-erpete tar-rinotrakeite felina, l-infezzjoni tal-kaliċivirus, u l-viruses tal-panlewkopenja felina.
English: For a full list of the side-effects reported with Purevax RCPCh FeLV, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Purevax RCPCh FeLV, ara l-fuljett ta' tagħrif.
English: In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly.
Maltese: Fl-istudju li eżamina t-tilqima booster, il-livelli tal-anitkorpi kontra l-virus tal-erpete tar-rinotrakeite, l-infezzjoni tal-kaliċivirus, u l-viruses tal-panlewkopenja felina u C. felis baqgħu stabbli f'livell għoli jew żdiedu bi ftit.
English: Purevax RCPCh FeLV contains small amounts of weakened or killed viruses and bacteria that cause feline viral rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia.
Maltese: Purevax RCPCh FeLV fih ammonti żgħar ta' viruses u ta' batterji mdgħajfa jew maqtula li jikkawżaw ir-rinotrakeite, il-kaliċivirożi, il-klamidjożi u l-panlewkopenja tal-qtates.
English: What is Purevax RCPCh FeLV?
Maltese: X'inhu Purevax RCPCh FeLV?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh FeLV exceed the risks for the approved indications and recommended that Purevax RCPCh FeLV be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Purevax RCPCh FeLV huma akbar mir-riskji għall-kura tal-indikazzjoni approvata u rrakkomanda li Purevax RCPCh FeLV jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Purevax RCPCh FeLV is used to vaccinate cats from the age of 8 weeks against:
Maltese: Purevax RCPCh FeLV jintuża sabiex il-qtates mill-età ta' 8 ġimgħat ‘il fuq jitlaqqmu kontra:
English: • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),
Maltese: • il-kaliċivirożi felina (marda li tixbah l-influwenza b'infjammazzjoni tal-ħalq ikkawżata minn kaliċivirus),
English: The vaccine helps to reduce the symptoms of the diseases.
Maltese: It-tilqima tgħin tnaqqas is-sintomi tal-mard.
English: Purevax RCPCh FeLV is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Maltese: Purevax RCPCh FeLV huwa disponibbli bħala lijofilizzat (pilloli f'boċċi żgħar imnixxfa bl-iffriżar li fihom il-mediċina) u solvent li jitħalltu flimkien f'sospensjoni għal injezzjoni.
English: Why has Purevax RCPCh FeLV been approved?
Maltese: Għaliex ġie approvat Purevax RCPCh FeLV?
English: It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study.
Maltese: L-identifikazzjoni ta' żieda fl-antikorpi kontra C. felis ma kinitx possibbli minħabba livelli għoljin ta' antikorpi fil-qtates fil-bidu tal-istudju.
English: In laboratory conditions, Purevax RCPCh FeLV was demonstrated to provide protection against the diseases listed above.
Maltese: F'kundizzjonijiet ta' laboratorju, Purevax RCPCh FeLV intwera li jipprovdi protezzjoni kontra l-mard elenkat hawn fuq.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju jista' jinstab fil-modulu ta' diskussjoni xjentifika ta' dan l-EPAR.
English: • feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus),
Maltese: • il-panlewkopenja felina (marda serja li tikkawża dijarea bid-demm ikkawżata minn parvovirus),
English: EMA/CHMP/472762/2013 EMEA/H/C/003755
Maltese: EMA/472762/2013 EMEA/H/C/003755
English: The full EPAR for Xoterna Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Xoterna Breezhaler jista' jinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Indacaterol / glycopyrronium
Maltese: Indakaterol / glikopirronju
English: Indacaterol is a long-acting beta-2 agonist.
Maltese: L-indakaterol huwa agonista beta-2 li jaġixxi fit-tul.
English: Glycopyrronium is a muscarinic receptor antagonist.
Maltese: Il-glikopirronju huwa riċettur antagonita muskariniku.
English: This summary was last updated in 09-2013.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi: 09-2013.
English: Xoterna Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Maltese: Xoterna Breezhaler huwa mediċina li fiha żewġ sustanzi attivi, l-indakaterol (85 mikrogramma) u lglikopirronju (43 mikrogramma).
English: Xoterna Breezhaler has been studied in two main studies involving a total of 2,667 patients with COPD.
Maltese: Xoterna Breezhaler ġie studjat f'żewġ studji ewlenin li involvew total ta' 2,667 pazjent b'COPD.
English: This is a summary of the European public assessment report (EPAR) for Xoterna Breezhaler.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Xoterna Breezhaler.
English: It is used as maintenance (regular) treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Jintuża bħala kura ta' manteniment (regolari) biex itaffi s-sintomi talmarda kronika ostruttiva tal-pulmun (COPD) fl-adulti.