FrancophonIA/ELRC3.0 huggingface dataset:
English: It must also not be used in patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors or in patients with a history of certain medical conditions.
Maltese: Ma għandux jintuża f'pazjenti li qegħdin jieħdu mediċini magħrufin bħala inibituri ta' monoamine oxidase mhux selettivi (MAO) jew f'pazjenti bi storja ta' ċerti kundizzjonijiet mediċini.
English: Numient capsules are taken with a glass of water.
Maltese: Il-kapsuli ta' Numient jittieħdu ma' tazza ilma.
English: Patients who have difficulty swallowing can have the content of the capsules sprinkled on soft food such as apple sauce, yoghurt or pudding.
Maltese: Il-pazjenti li għandhom diffikultà biex jibilgħu jistgħu jraxxu l-kontenut tal-kapsuli fuq ikel artab bħal zalza tat-tuffieħ, jogurt jew pudina.
English: In a study of 381 patients with early stage Parkinson's disease, Numient at various doses was more effective at improving symptoms than placebo (a dummy treatment).
Maltese: Fi studji ta' 381 pazjent b'marda ta' Parkinson fi stadju bikri, Numient f'diversi dożi kien iktar effikaċi biex itejjeb is-sintomi minn plaċebo (kura finta).
English: Studies show that Numient is effective at reducing symptoms in patients with early and late stage Parkinson's disease.
Maltese: Studji juru li Numient huwa effikaċi fit-tnaqqis tas-sintomi f'pazjenti b'marda ta' Parkinson fi stadju bikri u avvanzat.
English: More serious side effects include bleeding from the gut and allergic reactions, and have been reported uncommonly.
Maltese: Effetti sekondarji iktar serji jinkludu fsada mill-imsaren u reazzjonijiet allerġiċi, u ġew irrapportati b'mod mhux komuni.
English: How is Numient used?
Maltese: Kif jaħdem Numient?
English: Another benefit is the way the active substances are formulated in Numient, which helps maintain more steady levodopa levels.
Maltese: Benefiċċju ieħor huwa l-mod li bih is-sustanzi attivi huma fformulati f'Numient, li jgħin iżomm livelli iktar stabbli ta' levodopa.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Numient's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Numient huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: In patients with Parkinson's disease, the cells in the brain that produce dopamine, a neurotransmitter important for controlling movement, begin to die and the amount of dopamine in the brain decreases.
Maltese: F'pazjenti bil-marda ta' Parkinson, iċ-ċelloli fil-moħħ li jipproduċu d-dopamina, newrotrażmettitur importanti għall-ikkontrollar tal-movimenti, jibdew imutu u l-ammont ta' dopamina fil-moħħ jonqos.
English: Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer
Maltese: Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170
English: Potassium chloride Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Water for injections
Maltese: Potassium chloride Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Ilma għall-injezzjonijiet
English: ATCvet code: QI08AA
Maltese: Kodici ATĊ veterinarja QI08AA
English: Pregnant does should be handled with special care to avoid stress and risk of abortion
Maltese: Fniek tqal għandhom jiġu ttrattati b'attenzjoni speċjali biex ikun evitat stress u r-riskju ta' abort
English: Mineral oil
Maltese: Żejt minerali
English: Whitish emulsion.
Maltese: Emulsjoni bajdanija.
English: 1 x 40 doses (20 ml).
Maltese: 1 x 40 doża (20 ml).
English: Tel. +34 972 430660 Fax +34 972 430661 E-mail: hipra@hipra.com
Maltese: +34 972 430661 {e-mail}> hipra@hipra.com
English: Vial label (1, 10 or 40 doses)
Maltese: Kunjetti (1, 10 jew 40 doża)
English: Overdose (symptoms, emergency procedures, antidotes): No available data.
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti):
English: Mineral oil: ………………..104.125 mg
Maltese: Żejt minerali: ………………104.125 mg
English: 10 x 1 dose (0.5 ml).
Maltese: 10 x 1 doża (0.5 ml).
English: 1 x 10 doses (5 ml).
Maltese: 1 x 10 doża (5 ml).
English: Batch{number}
Maltese: Lott {numru}
English: Date of first authorisation: 22 September 2016
Maltese: Data tal-ewwel awtorizazzjoni: 22.09.2016
English: la Selva, 135 17170 Amer (Girona) SPAIN
Maltese: S.A. Avda. la Selva, 135 17170- AMER (Girona) SPANJA
English: Inactivated RHDV2, strain V-1037: ………….≥70% cELISA40
Maltese: RHDV2 inattivat, razza V-1037: ≥70% cELISA40
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: {MM/YYYY}
Maltese: Jiskadi {xahar/sena}
English: Type I colourless glass vials with 0.5 ml (1 dose), 5 ml (10 doses) and 20 ml (40 doses).
Maltese: Kunjett tal-ħġieġ mingħajr kulur tat-Tip I b'0.5 ml (1 doża), 5 ml (10 dożi) u 20 ml (40 doża).
English: Nodules or swelling (< 2 cm) can be very commonly observed in the injection site, which may last 24 hours.
Maltese: Noduli jew nefħa (<2 cm) jistgħu jiġu osservati ħafna fis-sit ta' injezzjoni, li jista' jdum 24 siegħa.
English: Administer 1 dose (0.5 ml) of the veterinary medicinal product to rabbits from the age of 30 days by subcutaneous injection in the lateral thoracic wall.
Maltese: Amministra doża waħda (0.5 ml) mill-prodott veterinarju mediċinali lil fniek mill-età ta' 30 jum b'injezzjoni taħt il-ġilda fil-ħajt toraċiku laterali.
English: The frequency of adverse reactions is defined using the following convention: -very common (more than 1 in 10 animals treated displaying adverse reaction (s) -common (more than 1 but less than 10 animals in 100 animals treated) -uncommon (more than 1 but less than 10 animals in 1,000 animals treated) -rare (more than 1 but less than 10 animals in 10,000 animals treated) -very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effett(i) mhux mixtieq(a)) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: The vaccine provides protection only against RHDV2, cross protection against classical RHDV has not been demonstrated.
Maltese: It-tilqima tipprovdi biss protezzjoni kontra RHDV2; protezzjoni inkroċjata kontra RHDV klassiku ma ntweritx.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: To stimulate active immunity against the rabbit haemorrhagic disease type 2 virus (RHDV2).
Maltese: Biex tistimola l-immunità attiva kontra l-mard emorraġiku tal-fniek virus tat-tip 2 (RHDV2).
English: Onset of immunity: 1 week Duration of immunity: 12 months demonstrated by challenge
Maltese: Bidu tal-immunità: Ġimgħa Tul tal-immunità:
English: Mineral oil…………104.125 mg
Maltese: ………………104.125 mg
English: Onset of immunity: 1 week.
Maltese: Ġimgħa Tul tal-immunità:
English: Laboratory studies in pregnant doe in the last third of gestation have not been produced any evidence of a teratogenic, foetotoxic and maternotoxic effects.
Maltese: Tqala Studji fil-laboratorji fuq fniek nisa fl-aħħar terz tal-ġestazzjoni ma produċew ebda evidenza ta' effetti teratoġeniċi, fetetotossiċi u maternotossiċi.
English: Store and transport refrigerated (2 ºC-8 ºC).
Maltese: Aħżen u ttrasporta fi friġġ (2 sa 8 °C).
English: Lethargy and/or inappetence may be observed very rarely in the first 48 hours after injection, based on post-authorisation pharmacovigilance reporting.
Maltese: Tista' tiġi osservata letarġija u/jew nuqqas ta' aptit b'mod rari ħafna fl-ewwel 48 siegħa wara t-tilqima, abbażi ta' rapportar ta' farmakoviġilanza ta' wara l-awtorizzazzjoni.
English: Laboratory studies in doe rabbits in the last third of gestation have not been produced any evidence of a teratogenic, foetotoxic and maternotoxic effects.
Maltese: Studji fil-laboratorji fuq fniek nisa fl-aħħar terz tal-ġestazzjoni ma produċew ebda evidenza ta' effetti teratoġeniċi, fetetotossiċi u maternotossiċi.
English: For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2).
Maltese: Għal immunizzazzjoni attiva ta' fniek minn 30 jum biex tnaqqas l-mortalità kkawżata minn mard emorraġiku tal-fniek virus tat-tip 2 (RHDV2).
English: Special precautions for use in animals Vaccination is recommended where RHDV2 is epidemiologically relevant.
Maltese: It-tilqim huwa rakkomandat fejn RHDV2 huwa epidemjoloġikament rilevanti.
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strainV-1037……≥70% cELISA40*
Maltese: Mard emorraġiku tal-fniek virus tat-tip 2 (RHDV2) mhux attivat, razzaV-1037……≥70% cELISA40*
English: No available data.
Maltese: M'hemm l-ebda dejta disponibbli.
English: ERAVAC emulsion for injection for rabbits
Maltese: VETERINARJU ERAVAC emulsjoni għal injezzjoni għall-fniek
English: ERAVAC emulsion for injection for rabbits.
Maltese: VETERINARJU ERAVAC emulsjoni għal injezzjoni għall-fniek.
English: Duration of immunity: 12 months demonstrated by challenge
Maltese: 12 xhur murija bi sfida
English: Revaccination: 12 months after vaccination.
Maltese: Tilqim mill-ġdid: 12 xhur wara t-tilqima.
English: Pharmacotherapeutic group: Inactivated viral vaccines for Leporidae, inactivated viral vaccine for rabbits.
Maltese: Tilqim virali inattivat għal Leparopidi, tilqima virali inattivata għall fniek.
English: ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Maltese: ≥70 % tal-fniek imlaqqma għandhom jagħtu titri tal-antikopri cELISA ugwali għal jew ogħla minn 40.
English: Each dose of 0.5 ml contains:
Maltese: Kull doża ta' 0.5 ml fiha:
English: This slight temperature increase resolves spontaneously without treatment by day 5 post vaccination.
Maltese: Din iż-żieda ħafifa fit-temperatura tirriżolvi ruħha b'mod spontajnu mingħajr kura sa jum 5 minn wara t-tilqima.
English: Cardboard box of 1 glass vial of 40 doses (20 ml).
Maltese: Kaxxa tal-kartun b'kunjett tal-ħġieġ 1 ta' 40 doża (20 ml).
English: Rabbits
Maltese: IEĦOR
English: Vaccination of rabbits induced the production of hemagglutination inhibition antibodies that persisted for at least 12 months.
Maltese: It-tilqim tal-fniek ikkaġuna l-produzzjoni ta' antikorpi ta' inibizzjoni tal-hemagglutination li ppersistew għal mill-inqas 12-il xahar
English: Cardboard box of 10 glass vials of 1 dose (0.5 ml).
Maltese: Kaxxa tal-kartun b'10 kunjetti tal-ħġieġ ta' doża 1 (0.5 ml).
English: A transient temperature increase slightly above 40 ºC might very commonly occur between two or three days following vaccination.
Maltese: Żieda temporanja fit-temperatura kemmxejn ogħla minn 40 ºC tista' sseħħ b'mod komuni ħafna bejn jumejn u tlett ijiem wara t-tilqima.
English: The full EPAR for Controloc Control 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: The active substance in Controloc Control, pantoprazole, is a proton pump inhibitor.
Maltese: Is-sustanza attiva f'Controloc Control, pantoprazole, hija inibitur tal-pompa tal-proton.
English: Controloc Control is a medicine that contains the active substance pantoprazole.
Maltese: Controloc Control huwa mediċina li fiha s-sustanza attiva pantoprazole.
English: This is a summary of the European public assessment report (EPAR) for Controloc Control.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Controloc Control.
English: The European Commission granted a marketing authorisation valid throughout the EU for Controloc Control on 12 June 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Controloc Control fit-12 ta' Ġunju 2009.
English: Controloc Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Controloc.
Maltese: Controloc Control huwa simili għal ‘mediċina ta' referenza' msejħa Controloc li hija diġà awtorizzata flUnjoni Ewropea (UE).
English: Other information about Controloc Control
Maltese: Informazzjoni oħra dwar Controloc Control
English: What is the risk associated with Controloc Control?
Maltese: X'inhu r-riskju assoċjat ma' Controloc Control?
English: What benefit has Controloc Control shown during the studies?
Maltese: Liema benefiċċji wera Controloc Control waqt l-istudji mwettqa?
English: Controloc Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Maltese: Controloc Control m'għandux jintuża f'nies li huma ipersensittivi (allerġiċi) għal pantoprazole, soja jew għal xi sustanza oħra tiegħu.
English: Controloc Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Maltese: Controloc Control jintuża għall-kura għal żmien qasir tas-sintomi ta' rifluss tal-aċidu fl-adulti.
English: The reference medicine, Controloc, is only available with a prescription.
Maltese: Il-mediċina ta' referenza, Controloc, hija disponibbli biss permezz ta' riċetta tat-tabib.
English: What is Controloc Control?
Maltese: Kif jintuża Controloc Control?
English: Why has Controloc Control been approved?
Maltese: Għaliex ġie approvat Controloc Control?
English: EMA/295022/2019 EMEA/H/C/004110
Maltese: 29 ta' Mejju 2019 EMA/295022/2019 EMEA/H/C/004110
English: The company that applied for authorisation is TLC Biopharmaceuticals B.V.
Maltese: Il-kumpanija li applikat għal awtorizzazzjoni hija TLC Biopharmaceuticals B.V.
English: Doxolipad is a cancer medicine that contains the active substance doxorubicin.
Maltese: Doxolipad huwa mediċina kontra l-kanċer li fiha s-sustanza attiva doxorubicin.
English: Refusal of the marketing authorisation for Doxolipad (doxorubicin)
Maltese: Doxolipad (doxorubicin)
English: What is Doxolipad?
Maltese: X'inhu Doxolipad?
English: The applicant presented data from the scientific literature, and data from studies conducted in experimental models, including comparisons with another authorised doxorubicin medicine, Caelyx, which contains doxorubicin in pegylated liposomal form.
Maltese: L-applikant ippreżenta dejta mil-letteratura xjentifika, u dejta minn studji li saru f'mudelli sperimentali, inkluż tqabbil ma' mediċina awtorizzata oħra ta' doxorubicin, Caelyx, li fiha doxorubicin f'forma lipożomali pegilata.
English: Doxolipad was developed as a ‘hybrid medicine'.
Maltese: Doxolipad ġie żviluppat bħala ‘mediċina ibrida'.
English: The active substance in Doxolipad, doxorubicin, is a cytotoxic medicine that belongs to the group ‘anthracyclines'.
Maltese: Is-sustanza attiva f'Doxolipad, doxorubicin, hija ċitotossika li tappartjeni għall-grupp ‘antraċiklini'.
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 29 May 2019.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, is-CHMP eżamina l-opinjoni mill-ġdid u kkonferma r-rifjut tal-awtorizzazzjoni għattqegħid fis-suq fid-29 ta' Mejju 2019.
English: In Doxolipad, it is enclosed in ‘pegylated liposomes' (tiny fatty spheres that are coated with a chemical called polyethylene glycol).
Maltese: F'Doxolipad, din tinsab ġo ‘lipożomi pegilati' (sferi tax-xaħam żgħar ħafna li huma miksija b'kimika msejħa polietilenglikol).
English: What was Doxolipad expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Doxolipad?
English: Doxolipad was expected to be used to treat metastatic breast cancer in patients at risk of heart problems (‘metastatic' means the cancer has spread to other parts of the body), and cancer of the ovary in women whose previous treatment including a platinum-based cancer medicine has stopped working.
Maltese: Doxolipad kien mistenni li jintuża biex jikkura kanċer tas-sider metastatiku f'pazjenti f'riskju ta' problemi tal-qalb (‘metastatiku' tfisser li l-kanċer ikun infirex għal partijiet oħra tal-ġisem), u kanċer tal-ovarji f'nisa li l-kura preċedenti tagħhom inkluż mediċina kontra l-kanċer ibbażata fuq il-platinu tkun waqfet taħdem.
English: 29 May 2019
Maltese: EMA/295022/2019
English: Therefore, the CHMP was of the opinion that there was insufficient evidence to show that Doxolipad was bioequivalent to Caelyx, and it was not possible to establish that the benefits of Doxolipad outweigh its risks.
Maltese: Għalhekk, is-CHMP kien tal-opinjoni li ma kienx hemm biżżejjed evidenza li turi li Doxolipad kien bijoekwivalenti għal Caelyx, u ma kienx possibbli li jiġi stabbilit li l-benefiċċji ta' Doxolipad huma akbar mir-riskji tiegħu.
English: On 31 January 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Doxolipad, intended for the treatment of breast and ovarian cancer.
Maltese: Fil-31 ta' Jannar 2019, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Doxolipad, maħsub għall-kura ta' kanċer tas-sider u tal-ovarji.
English: Doxorubicin has been available since the 1960s.
Maltese: Doxorubicin ilu disponibbli mis-sittinijiet.
English: For more information on hybrid medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar ilmediċini ibridi, ara d-dokument ta' mistoqsijiet u tweġibiet hawnhekk.
English: The company informed the CHMP that there are no ongoing clinical trials with Doxolipad in the EU.
Maltese: Il-kumpanija infurmat lis-CHMP li ma hemm l-ebda prova klinika għaddejja b'Doxolipad fl-UE.
English: It was to be available as a concentrate to be made into a solution for infusion (drip) into a vein.
Maltese: Dan kellu jkun disponibbli bħala konċentrat biex isir soluzzjoni għall-infużjoni (dripp) ġo vina.
English: The results of the bioequivalence study showed that Doxolipad is comparable to Caelyx in terms of ‘liposome-encapsulated doxorubicin', but failed to show that the amount of ‘free doxorubicin' is the same for the two medicines.
Maltese: Ir-riżultati tal-istudju tal-bijoekwivalenza wrew li Doxolipad huwa komparabbli għal Caelyx f'termini ta' ‘doxorubicin inkapsulat ġo lipożoma', iżda naqas milli juri li l-ammont ta' ‘doxorubicin ħieles' huwa listess għaż-żewġ mediċini.
English: This means that Doxolipad was intended to be similar to a ‘reference medicine' already authorised in the European Union called Adriamycin.
Maltese: Dan ifisser li Doxolipad kien maħsub biex ikun simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fl-Unjoni Ewropea msejħa Adriamycin.
English: The difference between the products is that in Doxolipad the active substance doxorubicin is enclosed in tiny fatty spheres called liposomes (see below for more details).
Maltese: Iddifferenza bejn il-prodotti hija li f'Doxolipad, is-sustanza attiva doxorubicin tinsab ġo sferi mxaħħmin żgħar ħafna li jissejħu lipożomi (ara hawn taħt għal aktar dettalji).
English: Because Doxolipad was developed as a hybrid medicine, the company also presented the results of a study carried out to investigate whether it is ‘bioequivalent' to Caelyx.
Maltese: Minħabba li Doxolipad ġie żviluppat bħala mediċina ibrida, il-kumpanija ppreżentat ukoll ir-riżultati ta' studju li sar biex jinvestiga jekk huwiex ‘bijoekwivalenti' għal Caelyx.
English: Although the reference medicine for Doxolipad is Adriamycin, this could not be used in the bioequivalence study because it contains doxorubicin in a different form (not enclosed in pegylated liposomes).
Maltese: Għalkemm il-mediċina ta' referenza għal Doxolipad hija Adriamycin, din ma setgħetx tintuża fl-istudju tal-bijoekwivalenza minħabba li fiha doxorubicin f'forma differenti (mhux ġo lipożomi pegilati).
English: They also reduce the medicine's effects on non-cancer cells, so it is less likely to cause some side effects.
Maltese: Dawn inaqqsu wkoll l-effetti talmediċina fuq ċelloli mhux tal-kanċer, b'hekk ikun hemm inqas probabbiltà li tikkawża xi effetti sekondarji.
English: The full EPAR for Oslif Breezhaler 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: The medicine contains the active substance indacaterol.
Maltese: Il-mediċina fiha s-sustanza attiva indacaterol.
English: The active substance in Oslif Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist.
Maltese: Is-sustanza attiva f'Oslif Breezhaler, indacaterol, hija agonista tar-riċettur adrenerġiku ta' beta-2.
English: Oslif Breezhaler is used for maintenance (regular) treatment.
Maltese: Oslif Breezhaler jintuża għall-kura ta' manteniment (regolari).
English: Overall, the effects of the 150 and 300 microgram doses of Oslif Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease.
Maltese: B'mod globali, l-effetti tad-dożi ta' 150 u 300 mikrogramma ta' Oslif Breezhaler kienu simili, iżda r-riżultati wrew li d-doża ta' 300 mikrogramma tista' tipprovdi solliev aħjar f'pazjenti b'mard iktar sever.
English: In three main studies involving over 4,000 patients with COPD, Oslif Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD).
Maltese: Fi tliet studji ewlenin li involvew 'il fuq minn 4,000 pazjent bis-COPD, Oslif Breezhaler tqabbel malplaċebo (kura finta), tiotropium jew formoterol (mediċini oħra li jiġu inalati li jintużaw għall-kura tasCOPD).
English: European Commission granted a marketing authorisation valid throughout the European Union for Oslif Breezhaler on 30 November 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Oslif Breezhaler fit-30 ta' Novembru 2009.
English: This is a summary of the European public assessment report (EPAR) for Oslif Breezhaler.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Oslif Breezhaler.
English: Oslif Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD).
Maltese: Oslif Breezhaler huwa mediċina li tintuża biex iżomm il-passaġġi tal-arja miftuħin f'adulti b'mard pulmonari ostruttiv kroniku (COPD, chronic obstructive pulmonary disease).
English: On average, the increase in FEV1 in patients who received Oslif Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml.
Maltese: Bħala medja, it-titjib ta' FEV1 f'pazjenti li rċevew Oslif Breezhaler kien madwar 150 u 190 ml, filwaqt li għal pazjenti li rċevew il-plaċebo il-bidla f'FEV1 varjat minn tnaqqis ta' 10 ml sa żieda ta' 20 ml.
English: Other information about Oslif Breezhaler
Maltese: Informazzjoni oħra dwar Oslif Breezhaler