FrancophonIA/ELRC3.0 huggingface dataset:
English: Natriuretic peptides also reduce blood pressure and protect the heart from developing fibrosis (scar tissues) that occurs in heart failure.
Maltese: Il-peptidi natrijuretiċi jnaqqsu wkoll il-pressjoni tad-demm u jħarsu l-qalb milli tiżviluppa fibrożi (tessuti taċ-ċikatriċi) li sseħħ f'insuffiċjenza tal-qalb.
English: Entresto tablets are taken twice a day.
Maltese: Il-pilloli ta' Entresto jittieħdu darbtejn kuljum.
English: Valsartan is an ‘angiotensin-II-receptor antagonist', which means that it blocks the action of a hormone called angiotensin II.
Maltese: Valsartan huwa tip ta' 'antagonista tar-riċettur tal-anġjotensina
English: In the main study, Entresto was compared to enalapril, another medicine used for heart failure.
Maltese: Fl-istudju ewlieni, Entresto tqabbel ma' enalapril, mediċina oħra użata għall-insuffiċjenza tal-qalb.
English: Entresto's serious side effects in the main study were similar to those of enalapril, which is already authorised for use in heart failure.
Maltese: L-effetti sekondarji serji ta' Entresto fl-istudju ewlieni kienu simili għal dawk ta' enalapril, li diġà huwa awtorizzat għall-użu f'insuffiċjenza tal-qalb.
English: The most common side effects with Entresto (which may affect more than 1 in 10 people) are high blood potassium levels, low blood pressure and the kidneys working less well.
Maltese: L-effetti sekondarji l-aktar komuni b'Entresto (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma livelli għoljin ta' potassju fid-demm, pressjoni baxxa tad-demm u l-kliewi jaħdmu b'mod anqas tajjeb.
English: Entresto must not be taken with medicines known as ACE inhibitors (which are used to treat heart failure and high blood pressure).
Maltese: Entresto ma għandux jittieħed ma' mediċini magħrufin bħala inibituri ACE (li jintużaw biex jikkuraw insuffiċjenza tal-qalb u pressjoni għolja tad-demm).
English: For the full list of all side effects reported with Entresto, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Entresto, ara l-fuljett ta' tagħrif.
English: ATCvet code: QI09AL08.
Maltese: Kodici ATC veterinarja : QI09AL08.
English: Date of first authorisation: 07/11/2014.
Maltese: Data tal-ewwel awtorizzazzjoni: 07/11/2014.
English: Avoid introduction of contamination.
Maltese: Evita li tindroduċi xi kontaminazzjoni.
English: Light mineral oil Aluminium hydroxide Sorbitan oleate Polysorbate 80
Maltese: Żejt minerali ħafif Aluminjum hydroxide Sorbitan oleate Polysorbate 80
English: Milton Keynes Buckinghamshire MK7 7AJ
Maltese: Buckinghamshire MK7 7AJ
English: EU/2/14/175/001 (20 ml) EU/2/14/175/002 (50 ml) EU/2/14/175/003 (100 ml) EU/2/14/175/004 (200 ml) EU/2/14/175/005 (500 ml) EU/2/14/175/006 (10x20 ml) EU/2/14/175/007 (10x50 ml) EU/2/14/175/008 (10x100 ml) EU/2/14/175/009 (10x200 ml) EU/2/14/175/010 (10x500 ml)
Maltese: EU/2/14/175/006 (10x20 ml) EU/2/14/175/007 (10x50 ml) EU/2/14/175/008 (10x100 ml) EU/2/14/175/009 (10x200 ml) EU/2/14/175/010 (10x500 ml)
English: 20 ml 50 ml 100 ml 200 ml 500 ml 10x20 ml 10x50 ml 10x100 ml 10x200 ml 10x500 ml
Maltese: 500 ml 10x20 ml 10x50 ml 10x100 ml 10x200 ml 10x500 ml
English: 1 Antigenic units as determined in the in vitro potency test (ELISA).
Maltese: 1 Units antiġeniċi kif determinati f'test tal-potenza in vitro (ELISA).
English: 30938 Burgwedel GERMANY
Maltese: 30938 Burgwedel Il-ĠERMANJA
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fil-friġġ (2°C - 8°C ).
English: Aluminium (as hydroxide)
Maltese: Aluminjum (bħala hydroxide)
English: Cardboard box with 1 or 10 vials of 20, 50, 100, 200 or 500 ml.
Maltese: Kaxxa tal-kartun b'1 jew 10 kunjetti ta' 20, 50, 100, 200 jew 500ml.
English: 100 ml 200 ml 500 ml
Maltese: 100 ml 200 ml
English: If such reactions occur, appropriate treatment is recommended.
Maltese: F'każ ta' reazzjonijiet simili, għandu jkun hemm it-trattament addattat.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - 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: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali trattati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal trattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal trattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal trattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati trattat).
English: PET (polyethylene terephthalate) vials of 20, 50, 100, 200 or 500 ml, closed with nitrile rubber stoppers and sealed with aluminium caps.
Maltese: Kunjetti PET (polyethylene terephtalate) ta' 20,50, 100, 200 jew 500ml, magħluqa b'tapp tal-gomma nitrile u ssiġillat b'kappa tal-aluminjum.
English: Intramuscular use.
Maltese: Mhux applikabbli.
English: Date of last renewal: dd/mm/yyyyy
Maltese: Data ta` l-aħħhar tiġdid: dd/mm/yyyyy
English: 2 ml contains:
Maltese: U KWANTITATTIVA 2 ml fiha:
English: EU/2/14/175/001-010
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/141/175/001-010
English: In laboratory studies and field trials:
Maltese: Fi studji fil-laboratorju u provi fil-post:
English: Per 2 ml: PCV2 ORF2 subunit antigen
Maltese: PCV2 ORF2 subunit antiġen
English: Ethyl alcohol Glycerol
Maltese: Ethyl alckoħol Gliċerina
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer OLANDA
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA(i) ATTIVA(I)
English: M. hyopneumoniae: 21 weeks after (the last) vaccination.
Maltese: M. hyopneumoniae: 21 ġimgħa wara (l-aħħar) l-vaċċinazzjoni.
English: Active substances:
Maltese: Sustanzi Attivi :
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: PCV2 ORF2 subunit antigen ≥ 2,828 AU M. hyopneumoniae inac.
Maltese: PCV2 ORF2 subunit antiġen ≥ 2,828 AU
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 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 tas-Sommarju tal-Karatteristiċi tal-Prodott huma jew 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 kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan ilprodott mediċinali veterinarju.
English: 20 ml 50 ml
Maltese: 20 ml
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/).
English: 2 Relative potency units defined against a reference vaccine.
Maltese: 2 Units ta' potenza relattiva kif imqabbla ma' vaċċin ta' referenza.
English: No data available.
Maltese: M'hemmx informazzjoni.
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated viral and inactivated bacterial vaccines for pigs.
Maltese: Immunoloġiċi għall-ħnieżer, vaċċini virali u batteriċi inattivati għallħnieżer.
English: The vaccine stimulates active immunity against porcine circovirus type 2 and Mycoplasma hyopneumoniae in pigs.
Maltese: Il-vaċċin jistimula immunità attiva kontra circovirus tal-ħnieżer tip 2 u Mycoplasma hyopneumoniae fil-ħnieżer.
English: Intervet International BV 5831 AN Boxmeer The NETHERLANDS
Maltese: Wim de Korverstraat 35 5831 AN Boxmeer OLANDA
English: The product stimulates the development of active immunity against porcine circovirus type 2 and Mycoplasma hyopneumoniae in pigs.
Maltese: Il-prodott jistimula immunità attiva kontra circovirus tal-ħnieżer tip 2 u Mycoplasma hyopneumoniae fil-ħnieżer.
English: The product literature of Porcilis PRRS should be consulted.
Maltese: Il-fuljett tal-informazzjoni tal Porcilis PRRS ghandu jigi kunsuktat.
English: Transient local injection site reactions, which are restricted to a slight swelling (< 2 cm diameter), may uncommonly occur.
Maltese: Reazzjonijiet tranżitorji fis-sit tal-injezzjoni, li huma restritti għal nefħa żgħira (< 2 cm dijametru), jistgħu rarament iseħħu.
English: M. hyopneumoniae: 4 weeks after vaccination.
Maltese: M.hyopneumoniae: 4 ġimġħat wara l-vaċċinazzjoni.
English: Cardboard box with 10 vials of 20 ml.
Maltese: Kaxxa tal-kartun b'10 kunjetti ta' 20ml.
English: For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection, and severity of lung lesions caused by Mycoplasma hyopneumoniae infection.
Maltese: Għall-immunità attiva tal-ħnieżer sabiex inaqqas viremija, l-ammont ta' virus fil-pulmun u t-tessuti tallimf, it-tixrid tal-virus ikkawżat minn infezzjoni tal-circovirus tal-ħnieżer tip2 (PCV2), u s-severità talleżjonijiet ikkawżati minn infezzjoni tal-Mycoplasma hyopneumoniae.
English: Two injections each of 1 ml in pigs starting at 3 days of age with an interval of at least 18 days.
Maltese: Żewġ injezzjonijiet ta` 1ml kull wieħed fi ħnieżer li jibdew minn 3 ijiem ta' età b`intervall ta` millanqas ta` 18 il-ġurnata.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR
English: Pigs for fattening
Maltese: Użu fil-muskolu
English: Cardboard box
Maltese: Mhux Applikabbli
English: The temperature returns to normal from 1 to 2 days after the peak temperature is observed.
Maltese: It-temperatura tirritorna għan-normal minn 1 sa 2 granet wara li lgħola temperatura li ġiet isservata.
English: Porcilis PCV M Hyo emulsion for injection for pigs
Maltese: VETERINARJU Porcilis PCV M Hyo emulsjoni għall-injezzjoni għall-ħnieżer
English: PCV2: 18 days after first vaccination M. hyopneumoniae: 3 weeks after the second vaccination.
Maltese: PCV2: 18 il-ġurnata wara l-ewwel vaċċinazzjoni M.hyopneumoniae: 3 ġimgħat wara t-tieni vaċċinazzjoni.
English: EXP {month/year} Once broached use within 8 hours.
Maltese: DATA TA' SKADENZA Jiskadi {xahar/sena} Ladarba jitħallat uża fi żmien 8 sigħat.
English: Cardboard box with 1 vial of 20 ml.
Maltese: Kaxxa tal-kartun b'1 kunjett ta' 20ml.
English: Disposal: read package leaflet.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq .
English: Mild systemic reactions may uncommonly be observed up to one day after vaccination and consist of being less active, a tendency of the animal to lie down and minor signs of discomfort.
Maltese: Sintomi ħfief sistemiċi jistgħu rarament jiġu osservati sa ġurnata wara l-vaċċinazzjoni u jikkonsistu f'anqas attività, tendenza tal-annimal li jimtedd u sinjali żgħar ta' skumdità.
English: Cardboard box with 1 vial of 100 ml.
Maltese: Kaxxa tal-kartun b'1 kunjett ta' 100ml.
English: Hypersensitivity reactions after vaccination may occur uncommonly.
Maltese: Rejazzjonijiet ta` ipersensittivita jistghu jsehhu rarament wara lvaccinazzjoni.
English: Cardboard box with 10 vials of 50 ml.
Maltese: Kaxxa tal-kartun b'10 kunjetti ta' 50ml.
English: Cardboard box with 1 vial of 500 ml.
Maltese: Kaxxa tal-kartun b'1 kunjett ta' 500ml.
English: To be supplied only on veterinary prescription.
Maltese: Tħallatx ma' ebda prodott mediċinali veterinarju ieħor.
English: Porcine circovirus type 2 (PCV2) ORF2 subunit antigen ≥ 2,828 AU1 Mycoplasma hyopneumoniae J strain inactivated
Maltese: Cirovirus tal-ħnieżer tip 2 (PCV2) ORF2 subunit antiġen
English: Cardboard box with 10 vials of 200 ml.
Maltese: Kaxxa tal-kartun b'10 kunjetti ta' 200ml.
English: Onset of immunity with two dose vaccination:
Maltese: Bidu tal-immunità b`doża waħda ta` vaċċinazzjoni:
English: Cardboard box with 1 vial of 50 ml.
Maltese: Kaxxa tal-kartun b'1 kunjett ta' 50ml.
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 tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Cardboard box with 10 vials of 100 ml.
Maltese: Kaxxa tal-kartun b'10 kunjetit ta' 100ml.
English: The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġika maħsuba sabiex tipproduċi immunità attiva ma taqax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: In individual pigs the temperature increase after associated use may commonly exceed 2°C.
Maltese: Fi hniezer individwali z-zieda fit- temperatura wara l-uzu flinkien tista komunament taqbes 2°C.
English: Cardboard box with 1 vial of 200 ml.
Maltese: Kaxxa tal-kartun b'1 kunjett ta' 200ml.
English: Cardboard box with 10 vials of 500 ml.
Maltese: Kaxxa tal-kartun b'10 kunjetti ta' 500ml
English: When PCV2 and/or M. hyopneumoniae infections occur early the two dose vaccination schedule is recommended.
Maltese: Meta infezzjoni tal-PVC2 u/jew M. hyopneumoniae isseħħ kmieni, l-iskeda taż-żewġ vaċċinazzjoni hija rakkomandata.
English: A transient increase in body temperature very commonly occurs on the day of vaccination (mean ±1 °C, in individual pigs up to 2 °C).
Maltese: Żieda tranżitorja fit-temperatura tal-ġisem spiss isseħħ filġurnata tal-vaċċinazzjoni (medja ±1 °C, f'xi majjali individwali sa 2°C).
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Maltese: Inkompatibilitajiet Tħallatx ma' ebda prodott mediċinali veterinarju.
English: Sodium chloride Water for injections
Maltese: Klorur tas-sodju
English: Light mineral oil
Maltese: Żejt minerali ħafif
English: Duration of immunity (both vaccination schedules): PCV2: 22 weeks after (the last) vaccination M. hyopneumoniae: 21 weeks after (the last) vaccination.
Maltese: Kemm iddum l-immunità (għaż-żewġ skedi ts` vaċċinazzjoni) PCV2: 22 ġimgħa wara (l-aħħar) l-vaċċinazzjoni.
English: PACKAGE LEAFLET: Porcilis PCV M Hyo emulsion for injection for pigs
Maltese: FIL-PAKKETT: Porcilis PCV M Hyo emulsjoni għall- injezzjoni għall-ħnieżer
English: This veterinary medicinal product contains mineral oil.
Maltese: Dan il-prodott fih żejt minerali.
English: Safety and efficacy data are available which demonstrate that this vaccine can be given with Porcilis PRRS at the same time at separate sites from 3 weeks of age.
Maltese: Hemm informazzjoni dwar is-sigurtà u l-effikaċja li turi li din t-tilqima tista tingħ ata mal- Porcilis PRRS fl-istess ħin f` postijiet differenti minn eta`ta` 3 ġimgħat.
English: Marketing authorisation holder and manufacturer responsible for batch release:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq u l-manifattur responsabbli għall-ħrug tal-lott:
English: Further information on Nerlynx 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 is available as tablets (40 mg).
Maltese: Il-mediċina tiġi bħala pilloli (40 mg).
English: Other information about Nerlynx
Maltese: Informazzjoni oħra dwar Nerlynx
English: The recommended dose is 6 tablets (240 mg) once a day with food, preferably in the morning.
Maltese: Id-doża rakkomandata hija 6 pilloli (240 mg) darba kuljum malikel, preferibbilment filgħodu.
English: Other common side effects (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, tiredness, belly pain, rash, decreased appetite, stomatitis (sore, inflamed mouth), and muscle spasms.
Maltese: Effetti sekondarji oħrajn komuni (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma nawsja (tħossok ma tiflaħx), rimettar, għeja, uġigħ ta' żaqq, raxx, tnaqqis fl-aptit, stomatite (ħalq juġgħuk u infjammat), u spażmi tal-muskoli.
English: The active substance in Nerlynx, neratinib, is a type of cancer medicine called a tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Nerlynx, in-neratinib, hija tip ta' mediċina tal-kanċer imsejħa inibitur tal-kinażi tattirożina.
English: Around 94% of the women given a year's treatment with Nerlynx lived for 1 further year after stopping Nerlynx without their cancer coming back versus 92% of those given placebo.
Maltese: Madwar 94 % tan-nisa li ngħataw kura għal sena b'Nerlynx għexu għal sena oħra wara li twaqqaf Nerlynx mingħajr ma rritorna l-kanċer tagħhom kontra 92 % ta' dawk li ngħataw plaċebo.
English: What are the risks associated with Nerlynx?
Maltese: X'inhuma r-riskji assoċjati ma' Nerlynx?
English: As for all medicines, data on the use of Nerlynx are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Nerlynx hija ssorveljata kontinwament.
English: When only women with hormone-receptor positive cancer were considered, about 95% of those given Nerlynx lived another year without the cancer coming back versus 91% of those given placebo.
Maltese: Meta tqiesu biss in-nisa b'kanċer pożittiv għar-riċettur tal-ormon, madwar 95 % ta' dawk li ngħataw Nerlynx għexu sena oħra mingħajr ma rritorna l-kanċer tagħhom kontra 91 % ta' dawk li ngħataw plaċebo.
English: Nerlynx has been shown to be more effective than placebo (a dummy treatment) at preventing the cancer from coming back in one main study involving 2,840 women with HER2-positive early breast cancer who had already received trastuzumab.
Maltese: Nerlynx intwera li huwa aktar effettiv minn plaċebo (kura finta) fil-prevenzjoni tal-kanċer milli jirritorna fi studju ewlieni wieħed li involva 2,840 mara b'kanċer tas-sider bikri pożittiv għall-HER2 li diġà kienu rċivew trastuzumab.
English: The doctor may reduce the dose or stop treatment if a patient has severe side effects, including diarrhoea.
Maltese: It-tabib jista' jnaqqas id-doża jew iwaqqaf il-kura jekk il-pazjent ikollu effetti sekondarji severi, inkluż dijarea.
English: How does Nerlynx work?
Maltese: Kif jaħdem Nerlynx?
English: Nerlynx must not be used in patients with severely reduced liver function.
Maltese: Nerlynx m'għandux jintuża f'pazjenti b'funzjoni tal-fwied indebolita severament.
English: Nerlynx is a breast cancer medicine used to reduce the risk of the disease coming back in patients with early breast cancer who have had surgery.
Maltese: Nerlynx huwa mediċina tal-kanċer tas-sider li tintuża biex tnaqqas ir-riskju li tirritorna l-marda f'pazjenti b'kanċer tas-sider bikri li saritilhom kirurġija.
English: Although the side effects, particularly diarrhoea, can be severe and lead to treatment being stopped, there would be patients with HER2-positive, hormone-receptor positive early breast cancer for whom treatment with Nerlynx after surgery and trastuzumab would be a reasonable option.
Maltese: Minkejja li l-effetti sekondarji, partikolarment id-dijarea, jistgħu jkunu severi u jwasslu sabiex titwaqqaf il-kura, ikun hemm pazjenti b'kanċer tas-sider bikri pożittiv għall-HER2 u pożittiv għarriċettur tal-ormon li għalihom kura b'Nerlyx wara kirurġija u trastuzumab tkun għażla raġonevoli.
English: The most common serious side effects are diarrhoea and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni serji huma dijarea u rimettar.
English: Why is Nerlynx authorised in the EU?
Maltese: Għaliex Nerlynx ġie awtorizzat fl-EU?
English: It is given following treatment with trastuzumab (another medicine used for the same purpose).
Maltese: Dan jingħata wara kura bi trastuzumab (mediċina oħra li tintuża għall-istess skop).
English: For the full list of side effects of Nerlynx, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Nerlynx, ara l-fuljett ta' tagħrif.
English: It is intended for use only in breast cancers that produce high levels of a protein called HER2, which helps cells to divide and grow (HER2-positive breast cancer), and that also have receptors (targets) for the female sex hormones (hormone-receptor positive breast cancer).
Maltese: Dan huwa maħsub biss għall-użu f'kanċers tas-sider li jipproduċu livelli għoljin ta' proteina msejħa HER2, li tgħin liċ-ċelloli jinqasmu u jikbru (kanċer tas-sider pożittiv għall-HER2), u li għandhom ukoll riċetturi (miri) għall-ormoni sesswali tan-nisa (kanċer tas-sider pożittiv għar-riċettur tal-ormon).
English: Nerlynx received a marketing authorisation valid throughout the EU on 31 August 2018.
Maltese: Ħarsa ġenerali lejn Nerlynx u għalfejn huwa awtorizzat fl-UE
English: Content
Maltese: Kontenut
English: --1 Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units
Maltese: --1 Strejn tal-virus ħaj myxoma vectored RHD 009: ≥103.0 u ≤106.1 FFU* *Focus Forming Units
English: Route of administration
Maltese: Metodu ta' amministrazzjo ni
English: Packaging
Maltese: Ippakjar
English: Lyophilisate: 5 vials; Solvent: 5 vials
Maltese: Lajofiliżejt: 5 fjali ; Solent 5 fjali
English: Lyophilisate: vial (glass); Solvent: vial (PET)
Maltese: Solvent: fjal (PET)
English: Target species
Maltese: Daqs talpakett
English: Lyophilisate: vial (glass); Solvent: vial (glass)
Maltese: Solvent: fjal (ħġieġ)
English: EU/1/14/983/001
Maltese: EU/1/14/983/001 Exviera
English: Blister (PVC/PE/PCTFE/ALU)
Maltese: Folja (PVC/PE/PCTFE/ALU)
English: 56 tablets (multipack)
Maltese: 56 pilloli (pakkett multiplu)
English: 250 mg Film-coated tablet Oral use
Maltese: 250 mg
English: 18 November 2010 EMA/703976/2010 EMEA/H/C/001217
Maltese: EMA/703976/2010
English: Formoterol is a long-acting beta-2 agonist.
Maltese: Formoterol huwa agonista beta-2 li jaġixxi fit-tul.
English: Mometasone is a corticosteroid with anti-inflammatory effects.
Maltese: Mometasone huwa kortikosterojde b'effetti anti-infjammatorji.
English: What is Zenhale?
Maltese: X'inhu Zenhale?
English: What was Zenhale expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Zenhale?
English: Zenhale is a medicine that contains the active substances mometasone furoate and formoterol fumarate.
Maltese: Zenhale hija mediċina li fiha s-sustanzi attivi mometasone furoate u formoterol fumarate.
English: The patients were treated with one of the following: Zenhale, mometasone furoate alone, formoterol fumarate alone, an asthma medicine containing fluticasone propionate and salmeterol (another combination of a steroid and a long-acting bronchodilator used in asthma), or placebo (a dummy treatment).
Maltese: Zenhale, mometasone furoate waħdu, formoterol fumarate waħdu, mediċina għall-ażżma li fiha fluticasone propionate u salmeterol (kombinazzjoni oħra ta' sterojde u bronkodilatur li jaġixxi fit-tul użat fl-ażżma), jew plaċebo (kura finta).
English: There were four main studies involving a total of 2,977 adults and adolescents who had been receiving treatment with inhaled corticosteroids or a combination of inhaled corticosteroid and a long-acting beta-2 agonist.
Maltese: Kien hemm erba' studji prinċipali li nvolvew total ta' 2,977 adult u adoloxxent li kienu qegħdin jirċievu kura b'kortikosterojdi li jittieħdu man-nifs għal ġol-pulmun jew b'kombinazzjoni ta' kortikosterojde li jittieħed man-nifs u agonista beta-2 li jaġixxi fit-tul.
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 evalwa d-dokumentazzjoni pprovduta mill-kumpanija u fformula lista ta' mistoqsijiet.