FrancophonIA/ELRC3.0 huggingface dataset:
English: Capsicum preparations are obtained by ethanol or propanol extraction (a technique used to extract compounds from plant parts by dissolving them in alcohol).
Maltese: Il-preparazzjonijiet tal-bżar jinkisbu bl-estrazzjoni tal-etanol jew propanol (teknika użata għallestrazzjoni ta' komposti minn partijiet tal-pjanta billi dawn jiddewbu fl-alkoħol.
English: Further information on the risks associated with capsicum 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 mal-mediċini bil-bżar, inklużi l-prekawzjonijiet xierqa għallużu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku talAġenzija:
English: In rare cases allergic skin reactions can occur.
Maltese: F'każijiet rari, jistgħu jseħħu reazzjonijiet allerġiċi fil-ġilda.
English: The capsaicin is used to overstimulate the TRPV1 receptors.
Maltese: Il-capsaicin tintuża biex tistimula b'mod eċċessiv ir-riċetturi tal-TRPV1.
English: The HMPC conclusions on the use of capsicum medicines relief of muscle pain are based on their ‘wellestablished use' in this condition.
Maltese: Mediċini bil-bżar jistgħu jikkawżaw ħmura u sensazzjoni ta' ħruq fuq iż-żoni tal-ġilda fejn jiġu applikati.
English: EU/2/11/130/002
Maltese: EU/2/11/130/001 EU/2/11/130/002 EU/2/11/130/003
English: Adjuvants: Aluminium hydroxide (Al3+)
Maltese: Aluminium hydroxide (Al3+)
English: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 Aluminium hydroxide, saponin and thiomersal.
Maltese: Virus Bluetongue inattivat, serotip 1, strejn BTV-1/ ALG2006/01 E1 Aluminium hydroxide, saponin u thiomersal.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05/08/2011
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 05/08/2011
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta fil friġġ (2 °C-8 °C).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 1 Bovis suspension for injection for cattle
Maltese: VETERINARJU Zulvac 1 Bovis suspensjoni għall-injezzjoni għall-baqar
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20ml, 1 x 100ml and 1 x 240ml
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun 1 x 20ml, 1 x 100ml u 1 x 240ml
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each 2 ml dose contains:
Maltese: TAS-SUSTANZA(I) ATTIVA (I) Kull doża ta' 2ml:
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of the immunological veterinary medicinal products on the whole or part of their territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill kif emendata, Stat Membru jista, skont il-liġijiet nazzjonal tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f'sezzjoni 6.1 tal-Karatteristiċi tal-prodott fil-qosor huma sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: After second and third vaccination a rectal temperature increase of up to 1.3 °C and 2.8 °C respectively may occur very commonly one day after the injection and then rectal temperatures return to normal values.
Maltese: Wara t-tieni u t-tielet tilqima huwa komuni ħafna li jkun hemm żieda fit-temperatura tar-rektum sa 1.3 °C u 2.8 °C rispettivament jum wara l-injezzjoni imbagħad it-temperatura tar-rektum tiġi għall-valuri normali.
English: STATEMENT OF ACTIVE SUBSTANCES Per dose of 2 ml:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull doża ta' 2ml:
English: Interactions with other medical products and other forms of interaction:
Maltese: Interazzjoni ma' prodotti mediċinal oħrajn u forom oħrajn ta' interazzjoni:
English: Cardboard box with one type II glass vial of either 100 ml (containing 50 doses) or 240 ml (containing 120 doses) with a chlorobutyl rubber stopper and aluminium cap.
Maltese: Kaxxa tal-kartun b'kunjett wieħed tal-ħġieġ tat-Tip II ta' 100ml (fih 50 doża) jew 240ml (fih 120 doża) b'għeluq ta' chlorobutyl rubber u siġill tal-aluminju.
English: Cardboard box with one type I glass vial of 20 ml (containing 10 doses) with a chlorobutyl rubber stopper and aluminium cap.
Maltese: Kaxxa tal-kartun b'kunjett wieħed tal-ħġieġ tat-Tip I ta' 20ml (fih 10 dożi) b'għeluq ta' chlorobutyl rubber u siġill tal-aluminju.
English: IMMUNOLOGICAL PROPERTIES
Maltese: Applika proċeduri asettiċi tas-soltu
English: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1
Maltese: BTV-1/ALG2006/01 E1
English: ATCvet code: QI02AA08 To stimulate active immunity against Bluetongue Virus, serotype 1 in cattle.
Maltese: Biex jistimula immunità attiva kontra l-Virus Bluetongue, serotip 1 fil-baqar.
English: A slight to moderate increase of local reactions may commonly be observed after a 2-fold overdose lasting for a maximum of 56 days.
Maltese: Huwa komuni li wieħed josserva żieda ħafifa jew moderata f'reazzjonijiet lokali li jdumu sa massimu ta' 56 ġurnata, wara doża eċċessiva ta' darbtejn aktar minn dik rakkomandata.
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in calves.
Maltese: RP* ≥ 1 * Qawwa Relattiva skont test ta' qawwa fil-ġrieden imqabbel ma' tilqima ta' referenza li ntweriet li hija effikaċi fil-baqar.
English: After administration of a two-fold overdose a rectal temperature increase up to 2.1ºC may occur 1 day after the injection and then rectal temperatures return to normal values.
Maltese: Wara l-għoti ta' doża doppja, jista' jkun hemm żieda fit-temepratura tar-rektum sa 2.1ºC jum wara linjezzjoni imbagħad it-temperatura tar-rektum tiġi għall-valuri normali.
English: Onset of immunity: 15 days after completion of the primary vaccination scheme.
Maltese: Bidu ta' l-immunità: 15-il ġurnata wara li jitlesta l-kors primarju ta' tilqim.
English: Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus.
Maltese: Vaċċini b'virus inattivat -Bluetongue virus Kodici ATC veterinarja: QI02AA08
English: Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Maltese: Kull skeda ta' tilqim mill-ġdid għandha tiġi approvata mill-Awtorità Kompetenti jew mill-veterinarju responsabbli, li għandhom jikkunsidraw is-sitwazzjoni epidemjoloġika lokali.
English: After first vaccination a rectal temperature increase of up to 1.6 °C may occur very commonly the 3rd day after the injection.
Maltese: Wara l-ewwel tilqima huwa komuni ħafna li jkun hemm żieda fit-temperatura tar-rektum sa 1.6 °C fittielet jum wara l-injezzjoni imbagħad it-temperatura tar-rektum tiġi għall-valuri normali.
English: Excipient: Thiomersal
Maltese: KWALITAJIET IMMUNOLOĠIĊI
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Maltese: Għal tilqim attiv ta' baqar minn xahrejn u nofs għall-prevenzjoni* ta' viremija kkawżata mill-virus Bluetongue (BTV), serotip 1. *(Valur cycling (Ct) ≥ 36 minn metodu RT_PCR validat, jindika li m'hemmx preżenza tal-ġenom virali)
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
Maltese: Sabiex tiġi evitata kontaminazzjoni aċċidentali tal-vaċċin waqt l-użu, huwa rrakkomandat li tintuża sistema ta' tilqim tat-tip ta' ‘aktar minn injezzjoni waħda' meta jintużaw preżentazzjonijiet ta' dożi akbar.
English: The full EPAR for Stocrin 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 Stocrin, efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Maltese: Is-sustanza attiva fi Stocrin, l-efavirenz, hija inibitur mhux nukleosidiku tat-traskriptażi inversa (NNRTI, non-nucleoside reverse transcriptase inhibitor).
English: The recommended dose of Stocrin for adults is 600 mg once a day.
Maltese: Id-doża rakkomandata ta' Stocrin għall-adulti hija 600 mg darba kuljum.
English: This is a summary of the European public assessment report (EPAR) for Stocrin.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Stocrin.
English: Stocrin has shown benefit in controlling HIV infection in three main studies involving over 1,100 adults.
Maltese: Stocrin wera benefiċċju fil-kontroll ta' infezzjoni tal-HIV fi tliet studji ewlenin li involvew aktar minn 1,100 adult.
English: Other information about Stocrin
Maltese: Informazzjoni oħra dwar Stocrin
English: Stocrin is an antiviral medicine that is used together with other antiviral medicines to treat patients aged three years or older infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Stocrin huwa mediċina antivirali li tintuża flimkien ma' mediċini antivirali oħra biex jikkura pazjenti ta' tliet snin jew iktar infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża ssindromu tal-immunodefiċjenza akkwiżita (AIDS).
English: The Stocrin combination was more effective than the combination without Stocrin: 70% and 30% of the patients, respectively, had viral loads below 500 copies/ml after 48 weeks;
Maltese: Il-kombinazzjoni bi Stocrin kienet aktar effettiva millkombinazzjoni mingħajr Stocrin: 70 % u 30 % tal-pazjenti, rispettivament, kellhom tagħbijiet virali taħt il-500 kopja/ml wara 48 ġimgħa;
English: 67% of the adults treated with Stocrin in combination with zidovudine and lamivudine had viral loads below 400 copies/ml after 48 weeks, compared with 54% of the patients treated with Stocrin and indinavir, and 45% of the patients treated with indinavir, lamivudine and zidovudine;
Maltese: • fl-ewwel studju, Stocrin flimkien ma' lamivudine u zidovudine jew ma' indinavir (mediċini antivirali oħra), tqabbel mal-kombinazzjoni ta' indinavir, lamivudine u zidovudine. 67 % tal-adulti kkurati bi Stocrin flimkien ma' zidovudine u lamivudine kellhom tagħbijiet virali taħt l-400 kopja/ml wara 48 ġimgħa, meta mqabbla ma' 54 % tal-pazjenti kkurati bi Stocrin u indinavir, u 45 % tal-pazjenti kkurati b'indinavir, lamivudine u zidovudine;
English: Similar results were seen in a study in 57 children aged between 3 and 16 years, given Stocrin in combination with nelfinavir and other antiviral medicines.
Maltese: Dehru riżultati simili fi studju f'57 tifel u tifla ta' bejn 3 snin u 16-il sena, li ngħataw Stocrin flimkien ma' nelfinavir u mediċini antivirali oħra.
English: Why is Stocrin approved?
Maltese: Għaliex ġie approvat Stocrin?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stocrin on 28 May 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Stocrin fit-28 ta' Mejju 1999.
English: It is available as capsules, tablets and oral solution and must be given in combination with other antiviral medicines.
Maltese: Dan jiġi bħala kapsuli, pilloli u soluzzjoni orali u għandu jingħata flimkien ma' mediċini antivirali oħra.
English: In all of the studies, the main measure of effectiveness was the number of patients with undetectable levels of HIV-1 in their blood (viral loads) after 24 or 48 weeks of treatment:
Maltese: Fl-istudji kollha, il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti b'livelli ta' HIV 1 li ma jistgħux jiġu osservati fid-demm tagħhom (tagħbijiet virali) wara kura ta' 24 jew 48 ġimgħa:
English: What are the risks associated with Stocrin?
Maltese: X'inhuma r-riskji assoċjati ma' Stocrin?
English: The European Medicines Agency decided that Stocrin's benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents, and children three years of age and older and recommended that it be approved for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Stocrin huma akbar mir-riskji tiegħu filkura kombinata ta' antivirali ta' adulti, adolexxenti u tfal ta' età ta' tliet xhur jew aktar infettati bl-HIV u rrakkomandat li jkun approvat għall-użu fl-UE.
English: The Agency noted that Stocrin has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Maltese: L-Aġenzija nnutat li Stocrin ma ġiex studjat biżżejjed f'pazjenti b'marda avvanzata (għadd ta' ċelloli CD4 inqas minn 50 ċellola/mm3) jew wara kura b'inibituri tal-proteażi (tip ta' mediċina antivirali oħra) li ma kinitx qed taħdem.
English: Stocrin can affect the electrical activity of the heart and so must also not be used in patients with heart problems such as changes in heart rhythm and activity, slow heart rate or heart failure or other conditions that can affect the heart's electrical activity, or who have close relatives that have died suddenly from a heart condition or were born with heart problems.
Maltese: Stocrin jista' jaffettwa l-attività elettrika tal-qalb u għalhekk lanqas m'għandu jintuża f'pazjenti bi problemi tal-qalb bħal tibdil fir-ritmu jew fl-attività tat-taħbit tal-qalb, rata ta' taħbit tal-qalb bil-mod jew insuffiċjenza kardijaka jew kondizzjonijiet oħra li jistgħu jaffettwaw l-attività elettrika tal-qalb, jew li għandhom qraba viċini li mietu f'daqqa minn kondizzjoni tal-qalb jew li twieldu bi problemi tal-qalb.
English: • the third study compared adding Stocrin or placebo (a dummy treatment) to a combination of antiviral medicines that included indinavir and two other antiviral medicines, in patients who had already been receiving treatment for HIV infection.
Maltese: • it-tielet studju qabbel iż-żieda ta' Stocrin jew plaċebo (kura finta) ma' kombinazzjoni ta' mediċini antivirali li kienu jinkludu indinavir u żewġ mediċini antivirali oħra, f'pazjenti li diġà kienu qed jirċievu kura għall-infezzjoni tal-HIV.
English: The most common side effect with Stocrin (seen in more than 1 patient in 10) is rash.
Maltese: L-effett sekondarju l-aktar komuni bi Stocrin (li deher f'aktar minn pazjent 1 minn kull 10) huwa raxx.
English: Taking Stocrin with food may lead to an increase in the frequency of side effects.
Maltese: It-teħid ta' Stocrin mal-ikel jista' jwassal għal żieda fil-frekwenza ta' effetti sekondarji.
English: • the second study compared Stocrin in combination with nelfinavir and two other antiviral medicines with the same combination without Stocrin.
Maltese: • it-tieni studju qabbel Stocrin flimkien ma' nelfinavir u żewġ mediċini antivirali oħra mal-istess kombinazzjoni mingħajr Stocrin.
English: How is Stocrin used?
Maltese: Kif jaħdem Stocrin?
English: By blocking this enzyme, Stocrin, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Billi jimblokka din l-enzima, Stocrin, meħud flimkien ma' mediċini antivirali oħra, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: It is recommended that Stocrin be taken on an empty stomach and without food, preferably at bedtime.
Maltese: Huwa rakkomandat li Stocrin jittieħed fuq stonku vojt u mingħajr ikel, preferibbilment mal-ħin tal-irqad.
English: Stocrin does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Maltese: Stocrin ma jfejjaqx infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara li ssir lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: For patients who are unable to swallow the capsules or tablets, Stocrin can be given using the oral solution.
Maltese: Għal pazjenti li ma jistgħux jibilgħu l-kapsuli jew il-pilloli, Stocrin jista' jingħata permezz ta' soluzzjoni orali.
English: Stocrin is also commonly associated with dizziness, headache, nausea (feeling sick) and tiredness.
Maltese: Stocrin huwa assoċjat b'mod komuni wkoll ma' sturdament, uġigħ ta' ras, nawżja (tħossok ma tiflaħx) u għeja.
English: More patients receiving Stocrin had viral loads below 400 copies/ml than those taking placebo after 24 weeks
Maltese: Aktar pazjenti li kienu qed jirċievu Stocrin kellhom tagħbijiet virali taħt l-400 kopja/ml minn dawk li kienu qed jieħdu l-plaċebo wara 24 ġimgħa
English: In patients aged 3 to 17 years, the dose depends on body weight.
Maltese: F'pazjenti minn 3 snin sa 17il sena, id-doża tiddependi mill-piż tal-ġisem.
English: Further information on Laventair Ellipta 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: Each inhalation provides 65 micrograms of umeclidinium bromide (equivalent to 55 micrograms of umeclidinium) and 22 micrograms of vilanterol.
Maltese: Kull inalazzjoni tipprovdi 65 mikrogramma ta' umeclidinium bromide (ekwivalenti għal 55 mikrogramma ta' umeclidinium) u 22 mikrogramma ta' vilanterol.
English: Laventair Ellipta received a marketing authorisation valid throughout the EU on 8 May 2014.
Maltese: Laventair Ellipta rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fit-8 ta' Mejju 2014.
English: The most common side effects with Laventair Ellipta (which may affect up to 1 in 10 people) are upper respiratory tract infections (nose and throat infection), urinary tract infections (infection of the structures that carry urine), pharyngitis (inflammation of the throat), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough, oropharyngeal pain (pain in the mouth and throat), constipation and dry mouth.
Maltese: L-effetti sekondarji l-aktar komuni b'Laventair Ellipta (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma infezzjonijiet fl-apparat respiratorju ta' fuq (infezzjoni fl-imnieħer u fil-griżmejn), infezzjonijiet flapparat tal-awrina (infezzjoni tal-istrutturi li jġorru l-awrina), farinġite (infjammazzjoni tal-griżmejn), sinusite (infjammazzjoni tas-sinusis), nażofarinġite (infjammazzjoni tal-imnieħer u l-griżmejn), uġigħ ta' ras, sogħla, uġigħ orofarinġeali (uġigħ fil-ħalq u l-griżmejn), stitikezza u ħalq xott.
English: Umeclidinium bromide is a muscarinic receptor antagonist.
Maltese: L-umeclidinium bromide hija antagonista tar-riċettur muskariniku.
English: Other information about Laventair Ellipta
Maltese: Informazzjoni oħra dwar Laventair Ellipta
English: Laventair Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Laventair Ellipta huwa mediċina użata biex ittaffi s-sintomi tal-mard pulmonari ostruttiv kroniku (COPD) fl-adulti.
English: Laventair Ellipta contains the active substances umeclidinium bromide and vilanterol.
Maltese: Laventair Ellipta fih is-sustanzi attivi umeclidinium bromide u vilanterol.
English: Laventair Ellipta and a higher-dose combination of umeclidinium bromide and vilanterol were compared with placebo (a dummy treatment), vilanterol alone, umeclidinium bromide alone and another COPD medicine called tiotropium in 4 main studies.
Maltese: Laventair Ellipta u kombinazzjoni ta' doża ogħla ta' umeclidinium bromide u vilanterol tqabblu ma' plaċebo (kura finta), vilanterol waħdu, umeclidinium bromide waħdu u mediċina oħra tas-COPD imsejħa tiotropium f'4 studji ewlenin.
English: It works by attaching to beta-2 receptors found in the muscle cells of many organs including the airways in the lungs.
Maltese: Din taħdem billi teħel ma' riċetturi ta' beta-2 li jinsabu fiċ-ċelloli tal-muskoli ta' bosta organi inkluż il-passaġġi talarja fil-pulmun.
English: Previously known as Laventair.
Maltese: Preċedentement magħruf bħala Laventair.
English: Laventair Ellipta also increased FEV1 by an average of 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone.
Maltese: Laventair Ellipta żied ukoll il-FEV1 b'medja ta' 95 ml aktar minn vilanterol waħdu u bi 52 ml aktar minn umeclidinium bromide waħdu.
English: Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Maltese: Antagonisti tar-riċettur muskariniku u agonisti beta2 li jaġixxu fit-tul jiġu kkombinati b'mod komuni fil-ġestjoni ta' COPD.
English: Results showed that Laventair Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment.
Maltese: Ir-riżultati wrew li Laventair Ellipta tejjeb il-funzjoni tal-pulmun b'FEV1 medju ta' 167 ml aktar minn plaċebo wara 24 ġimgħa ta' kura.
English: What are the risks associated with Laventair Ellipta?
Maltese: X'inhuma r-riskji assoċjati ma' Laventair Ellipta?
English: Laventair Ellipta contains two active substances.
Maltese: Laventair Ellipta fih żewġ sustanzi attivi.
English: As for all medicines, data on the use of Laventair Ellipta are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Laventair Ellipta hija ssorveljata kontinwament.
English: In all 4 studies, involving over 4,700 patients, the main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Maltese: Fl-4 studji kollha, li involvew aktar minn 4,700 pazjent, il-kejl ewlieni tal-effikaċja kien ibbażat fuq ittibdil fil-volumi espiratorji furzati tal-pazjenti (FEV1, il-volum massimu ta' arja li persuna tista' toħroġ man-nifs f'sekonda).
English: How is Laventair Ellipta used?
Maltese: Kif jaħdem Laventair Ellipta?
English: The average increase in FEV1 with Laventair Ellipta was 90 ml more than with tiotropium after 24 weeks of treatment.
Maltese: Iż-żieda medja fil-FEV1 b'Laventair Ellipta kienet 90 ml aktar milli bi tiotropium wara 24 ġimgħa ta' kura.
English: Laventair Ellipta can only be obtained with a prescription.
Maltese: Aktar informazzjoni fuq Laventair Ellipta tinstab fis-sit elettroniku tal-Aġenzija:
English: 90 (3 x 30) tablets
Maltese: Daqs tal-pakkett flixkun (HDPE) 30 pillola flixkun (HDPE) 90 (3 x 30) pillola
English: [Actavis logo]
Maltese: [Logo tal-Actavis]
English: 1.0 mg/dl or 88 micromol/l.
Maltese: 1.0 mg/dl jew 88 micromol/l.
English: Actavis Italy S.p.A Via Pasteur, 10 20014 Nerviano (MI) Italy
Maltese: Actavis Italy S.p.A Via Pasteur, 10 20014
English: Reykjavíkurvegur 76-78 220 Hafnarfjörður Iceland
Maltese: Reykjavíkurvegur 76 78 220
English: <2D barcode carrying the unique identifier included.> <Not applicable.>
Maltese: <barcode 2D li jkollu identifikatur uniku inkluż.>