FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Ecalta, anidulafungin, is an antifungal medicine, which belongs to the group ‘echinocandins'.
Maltese: Is-sustanza attiva f'Ecalta, l-anidulafunġina, hija mediċina antifungali li tappartjeni għall-grupp tal‘ekinokandini'.
English: Ecalta should only be given by infusion, at a maximum rate of 1.1 mg per minute to avoid side effects: this corresponds to about three hours for the initial infusion, and one and a half hours for the subsequent infusions.
Maltese: Ecalta għandu jingħata biss b'infużjoni, b'rata massima ta' 1.1 mg fil-minuta biex jiġu evitati effetti sekondarji: dan jikkorrispondi għal madwar tliet sigħat għall-infużjoni inizjali u siegħa u nofs għall-infużjonijiet sussegwenti.
English: An analysis of other studies evaluated the effects Ecalta in 46 patients with neutropenia.
Maltese: Analiżi ta' studji oħrajn evalwat l-effetti ta' Ecalta f'46 pazjent b'newtropenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ecalta on 20 September 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Ecalta valida fl-Unjoni Ewropea kollha fl-20 ta' Settembru 2007.
English: What is the risk associated with Ecalta?
Maltese: X'riskju huwa assoċjat ma' Ecalta?
English: In the analysis of patients with neutropenia, around 57% of patients (26 out of 46) had responded to treatment.
Maltese: Fl-analiżi tal-pazjenti b'newtropenja, madwar 57% tal-pazjenti (26 minn 46) irrispondew għall-kura.
English: The most common side effects with Ecalta (seen in more than 1 patient in 10) are diarrhoea, nausea (feeling sick) and hypokalaemia (low blood potassium levels).
Maltese: L-effetti sekondarji l-aktar komuni b'Ecalta (li dehru f'aktar minn pazjent wieħed minn kull 10) huma dijarrea, dardir (tħossok se tirremetti) u ipokalimija (livelli baxxi ta' potassju fid-demm).
English: Ecalta is a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Ecalta huwa trab li jsir soluzzjoni għall-infużjoni (dripp) fil-vina.
English: Ecalta has been studied in one main study involving 261 patients with invasive candidiasis and who did not have neutropenia (low white blood cell counts).
Maltese: Ecalta ġie studjat fi studju ewlieni wieħed li involva 261 pazjent b'kandidjażi invażiva u li ma kellhomx newtropenja (livelli baxxi ta' ċelloli bojod fid-demm).
English: Why has Ecalta been approved?
Maltese: Għaliex ġie approvat Ecalta?
English: A risk management plan has been developed to ensure that Ecalta is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Ecalta jintuża bl-aktar mod sigur possibbli.
English: A response was defined as a significant or complete improvement of symptoms, with no need for further antifungal treatment and no Candida found in the specimens taken from the patient.
Maltese: Rispons kien definit bħala titjib sinifikanti jew komplut tas-sintomi, mingħajr ebda ħtieġa għal kura antifungali ulterjuri u mingħajr sinjali ta' Candida fil-kampjuni meħuda mill-pazjent.
English: What is Ecalta?
Maltese: X'inhu Ecalta?
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Ecalta's benefits are greater than its risks for the treatment of invasive candidiasis in adult patients.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Ecalta huma akbar mir-riskji tiegħu fil-kura tal-kandidjażi invażiva f'pazjenti adulti.
English: Ecalta was more effective than fluconazole in treating invasive candidiasis in non-neutropenic patients.
Maltese: Ecalta rriżulta aktar effikaċi minn fluconazole fil-kura ta' kandidjażi invażiva f'pazjenti mhux newtropeniċi.
English: The list of fungi against which Ecalta is active can be found in the summary of product characteristics (also part of the EPAR).
Maltese: Illista ta' fungi li Ecalta huwa attiv kontrihom hija disponibbli fis-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: However, the Committee noted that Ecalta has been studied mainly in patients with candidaemia (Candida in the blood) and only in a limited number of patients with neutropenia (low white blood cell counts) or deep tissue infections or abscesses.
Maltese: Madankollu, il-Kumitat innota li Ecalta ġie studjat prinċipalment f'pazjenti b'kandidemija (Candida fid-demm) u f'numru limitat biss ta' pazjenti b'newtropenja (livelli baxxi ta' ċelloli bojod fid-demm) jew infezzjonijiet fil-fond tattessuti jew axxessi.
English: Ecalta is used to treat adult patients with invasive candidiasis (a fungal infection caused by a yeast called Candida).
Maltese: Ecalta jintuża biex jikkura pazjenti adulti b'kandidjażi invażiva (tip ta' infezzjoni fungali kkawżata minn ħmira bl-isem ta' Candida).
English: How has Ecalta been studied?
Maltese: Kif ġie studjat Ecalta?
English: Ecalta is available with or without a solvent.
Maltese: Ecalta huwa disponibbli flimkien ma' solvent jew waħdu.
English: Ecalta must not be used in people who are hypersensitive (allergic) to anidulafungin or any of the other ingredients, or to any other medicines in the echinocandin class.
Maltese: Ecalta ma għandux jintuża f'persuni li jistgħu jkunu ipersensittivi (allerġiċi) għall-anidulafunġina jew għal kwalunkwe ingredjent ieħor tiegħu, jew għal kwalunkwe mediċina oħra fil-klassi tal-ekinokandini.
English: What measures are being taken to ensure the safe and effective use of Ecalta?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Ecalta?
English: It works by interfering with the production of a component of the fungal cell wall called 1,3 β D glucan, which is necessary for the fungus to continue living and growing.
Maltese: Taħdem billi tinterferixxi mal-produzzjoni ta' komponent tal-ħajt taċ-ċellola fungali li jissejjaħ 1,3 β D glukan meħtieġ biex il-fungu jkompli jgħix u jikber.
English: November 2015
Maltese: Novembru 2015
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/02/2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 06/02/2015
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Sodium chloride Water for injections
Maltese: Kloru tal-potassa Potassium dihydrogen phosphate Disodium phosphate dihydrate Kloru tas-sodju
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated Schmallenberg virus (RP ≥ 1/dose)
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Virus ta' Schmallenberg inattivat (RP ≥ 1/doża)
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta fil-friġġ (2°C - 8°C).
English: Off-white or pink liquid.
Maltese: Likwidu off-white jew roża.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/178/001
Maltese: FIS-SUQ EU/2/14/178/001
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - 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: Magyarország Zoetis Hungary Kft. Tel: +361 224 5222
Maltese: Zoetis Hungary Kft. Tel: +361 224 5222
English: Deutschland Zoetis Deutschland GmbH Tel: +49 30 330063 0
Maltese: Zoetis Deutschland GmbH Tel: +49 30 330063 0
English: België/Belgique/Belgien Zoetis Belgium SA Tél/Tel.
Maltese: België/Belgique/Belgien Zoetis Belgium SA
English: * Below the level of detection by the validated RT-PCR method at 3.6 log10 RNA copies/ml of plasma for cattle and at 3.4 log10 RNA copies/ml of plasma for sheep.
Maltese: * Taħt il-livell li jitkejjel bil-metodu RT-PCR ivvalidat f'3.6 log10 RNA copies/ml tal-plażma għall-baqar u 3.4 log10 RNA copies/ml tal-plażma għan-nagħaġ.
English: Pharmacotherapeutic group: immunologicals for bovidae, inactivated viral vaccines for cattle.
Maltese: Grupp farmako-terapewtiku: immunoloġiċi għal bovidae, vaċċini virali inattivati għall-baqar.
English: Excipient: Thiomersal
Maltese: Ingedjenti oħra: Thiomersal
English: Inactivated Schmallenberg virus, strain BH80/11-4
Maltese: Strejn BH80/11-4 tal-virus ta' Schmallenberg inattivat
English: ATCvet code: QI02AA.
Maltese: QI02AA.
English: Luxembourg/Luxemburg Zoetis Belgium SA Tél/Tel.
Maltese: Luxembourg/Luxemburg Zoetis Belgium SA
English: PHARMACEUTICAL FORM Suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Sospensjoni għall-injezzjoni.
English: Τηλ.
Maltese: Xejn.
English: SC (sheep)
Maltese: SC (nagħaġ)
English: ROUTE(S) OF ADMINISTRATION IM (cattle)
Maltese: MOD(I) TA' AMMINISTRAZZJONI IM (baqar)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: intramuscular use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Baqar: użu fil-muskolu.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substance:
Maltese: Sustanza attiva:
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 immunological veterinary medicinal products on the whole or part of its 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 nazzjonali tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fitterritorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: The reactions may last for at least 47 days in the form of diffuse swelling of less than 2 cm diameter.
Maltese: Ir-reazzjonijiet jistgħu jdumu sa' tal-anqas 47 jum f'forma ta' nefħa diffuża ta' anqas minn 2 cm fiddijametru.
English: ZULVAC SBV is available in a cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine.
Maltese: SBV jiġi f'kaxxa tal-kartun b'kunjett wieħed ta' high density polyethylene (HDPE) b'tapp tal-chlorobutyl u siġill tal-aluminju, li fih 50 ml ta' vaċċin.
English: Primary vaccination: - For sheep from 3.5 months of age: administer one dose of 1 ml.
Maltese: - Għan-nagħaġ minn età ta' 3.5 xhur: amministra doża waħda ta' 1 ml.
English: Local reactions may very commonly appear in the vaccinated animals in the form of small intramuscular granulomas up to 0.7 cm of diameter that resolve in a maximum of 10 days.
Maltese: Huwa komuni ħafna li jidhru reazzjonijiet lokali flannimali mlaqqma f'forma ta' granulomi fil-muskolu sa 0.7 cm fid-dijametru li jitilqu wara massimu ta' 10 ijiem.
English: Cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' high density polyethylene (HDPE) b'tapp tal-chlorobutyl u siġill tal-aluminju, li fih 50 ml ta' vaċċin.
English: The reactions may persist for at least 97 days in the form of small granules of less than 0.5 cm of diameter.
Maltese: Ir-reazzjonijiet jistgħu jdumu sa' tal-anqas 97 jum f'forma ta' granuli żgħar ta' anqas minn 0.5 cm fiddijametru.
English: 0.1 mg * Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species
Maltese: 0.1 mg *Qawwa relattiva (test ta' qawwa fil-ġrieden) imqabbel ma' tilqima ta' referenza li ntweriet li hija effikaċi fl-ispeċi li fuqhom ser jintuża l-prodott
English: Zoetis B.V., Podružnica Zagreb za promidžbu
Maltese: U L-UŻU, JEKK APPLIKABBLI
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 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: Tel: +31 (0)10 714 0900
Maltese: Zoetis B.V. Tel: +31 (0)10 714 0900
English: Primary vaccination: - For cattle from 3.5 months of age: administer two doses of 2 ml three weeks apart.
Maltese: - Għall-baqar minn età ta' 3.5 xhur: amministra żewġ dożi ta' 2 ml tliet ġimgħat minn xulxin.
English: Booster vaccination: administer two doses of 2 ml three weeks apart, every twelve months.
Maltese: Tilqim mill-ġdid: amministra żewġ dożi ta' 2 ml tliet ġimgħat minn xulxin, kull 12-il xahar.
English: Zoetis B.V.
Maltese: KONTENUT BĦALA
English: To stimulate active immunity against Schmallenberg virus in cattle and sheep.
Maltese: Biex jistimola immunità attiva kontra l-virus ta' Schmallenberg fil-baqar u fin-nagħaġ.
English: Tel: +48 22 2234800
Maltese: Zoetis Polska Sp. z o.o. Tel: +48 22 2234800
English: Onset of immunity: 21 days after vaccination.
Maltese: Bidu tal-immunità: 21 jum wara t-tilqim.
English: Local reactions may very commonly appear in the vaccinated animals in the form of diffuse swellings or subcutaneous granulomas of up to a maximum diameter of 8 cm.
Maltese: Huwa komuni ħafna li jidhru reazzjonijiet lokali fl-annimali mlaqqma f'forma ta' nefħiet diffużi jew granulomi subkutanji sa 8 cm fid-dijametru.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Maltese: Staqsi lill-kirurgu veterinarju tiegħek dwar kif tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: Duration of immunity: 6 months after vaccination.
Maltese: Tul tal-immunità: 6 xhur wara t-tilqim.
English: Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 4.9 results in reduction of viraemia* and transplacental infection associated with infection by Schmallenberg virus during the first trimester of pregnancy.
Maltese: Tilqim ta' nagħaġ tat-tgħammir qabel it-tqala skont l-iskeda rakkomandata deskritta f'sezzjoni 4.9 jirriżulta f'riduzzjoni ta' virimja* u infezzjoni li tgħaddi mill-plaċenta assoċjata ma' infezzjoni talvirus ta' Schmallenberg waqt l-ewwel trimestru tat-tqala.
English: Name and address of the manufacturer of the biological active substance and the manufacturer responsible for batch release:
Maltese: Isem u indirizz tal-manufattur tas-sustanza bijoloġika attiva u manifattur responsabbli mill-ħruġ tallott:
English: For active immunisation of cattle from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus.
Maltese: Għat-tilqim attiv tan-nagħaġ minn età ta' 3.5 xhur biex tnaqqas il-virimja* assoċjata ma' infezzjoni mill-virus ta' Schmallenberg.
English: On a regular basis
Maltese: U KWANTITATTIVA
English: Tel: +34 91 4191900
Maltese: Zoetis Spain, S.L. Tel: +34 91 4191900
English: Oriola Vilnius UAB Tel: +370 610 05088
Maltese: Tel: +370 610 05088
English: In pregnant ewes, a transient increase in rectal temperature, not exceeding 0.8 ºC, may very commonly occur during the first 4 hours after vaccination.
Maltese: Fin-nagħaġ tqal huwa komuni ħafna li jkun hemm żieda li tgħaddi fit-temperatura tar-rektum ta' mhux aktar minn 0.8 °C, fl-ewwel 4 sigħat ta' wara t-tilqima.
English: At next commercial batch manufacture
Maltese: U METODU TA' AMMINISTRAZZJONI
English: Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 8 results in reduction of viraemia* and transplacental infection associated with infection by Schmallenberg virus during the first trimester of pregnancy.
Maltese: Tilqim ta' nagħaġ tat-tgħammir qabel it-tqala skont l-iskeda rakkomandata deskritta f'sezzjoni 8 jirriżulta għal riduzzjoni ta' virimija* u infezzjoni li tgħaddi mill-plaċenta assoċjata ma' infezzjoni talvirus ta' Schmallenberg waqt l-ewwel trimestru tat-tqala.
English: Adjuvants:
Maltese: Tqala:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZULVAC SBV suspension for injection for cattle and sheep
Maltese: Prodott mediċinali veterinarju li jingħata bir-riċetta.
English: Sheep:
Maltese: Baqar:
English: - For female sheep at breeding age:administer one dose of 1 ml at least 14 days prior to breeding.
Maltese: - Għal nagħaġ nisa fl-età tat-tgħammir: amministra doża waħda ta' 1 ml tal-anqas 14-il jum qabel ittgħammir.
English: Provide data to support the effectiveness of the antimicrobial preservative at the end of shelf life
Maltese: Jipprovdi data li jsostnu l-effiċenza tal-preservattiv kontra l-mikrobi
English: Sheep: subcutaneous use.
Maltese: Mhux applikabbli.
English: Provide stability results for batch 19512 at the end of shelf life
Maltese: Jipprovdi riżultati ta' stabilità għal-lott 19512 fl-aħħar tal-perjodu ta' kemm idum tajjeb il-prodott
English: Subcutaneous use (in the axillar region behind the elbow).
Maltese: Użu taħt il-ġilda (fiż-żona axxillari wara l-minkeb).
English: Cattle:
Maltese: Fertilità:
English: Continue to develop a test to quantify saponin in the finished product and provide regular updates on results
Maltese: Ikompli jiżviluppa test biex jitkejjel l-ammont ta' saponin fil-prodott finali u jipprovdi aġġornament regolari fuq ir-riżultati.
English: Zoetis Hellas S.A.
Maltese: SPEĊI LI GĦALIHOM
English: Read the package leaflet before use.
Maltese: U/JEW UŻU Mhux applikabbli.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Aluminium hydroxide Saponin
Maltese: • OBBLIGAZZJONI BIEX JITTIEĦDU MIŻURI WARA L-AWTORIZZAZZJONI
English: Amount per 1 ml dose (sheep)
Maltese: Ammont f'kull doża ta' 1 ml (nagħaġ)
English: The ‘class' reflects the severity of the disease: ‘class II' involves slight limitation of physical activity and ‘class III' involves marked limitation of physical activity.
Maltese: Il-“klassi” tirrifletti l-gravità tal-marda: “klassi II” tinvolvi limitazzjoni żgħira tal-attività fiżika u “klassi III” tinvolvi limitazzjoni notevoli tal-attività fiżika.
English: Further information on Ambrisentan Mylan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ambrisentan-mylan.
Maltese: ema.europa.eu/medicines/human/EPAR/ambrisentan-mylan.
English: Ambrisentan Mylan is available as tablets (5 and 10 mg).
Maltese: Ambrisentan Mylan jiġi bħala pilloli (5 u 10 mg).
English: Ambrisentan Mylan contains the active substance ambrisentan and is a ‘generic medicine'.
Maltese: Ambrisentan Mylan fih is-sustanza attiva ambrisentan u huwa ‘mediċina ġenerika'.
English: Other information about Ambrisentan Mylan
Maltese: Informazzjoni oħra dwar Ambrisentan Mylan
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Volibris, and do not need to be repeated for Ambrisentan Mylan.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu awtorizzat tal-mediċina ta' referenza, Volibris, u m'hemmx għalfejn jiġu ripetuti għal Ambrisentan Mylan.
English: When taken with ciclosporin (a medicine that reduces the activity of the immune system) the dose of Ambrisentan Mylan should be 5 mg daily and the patient should be closely monitored by their doctor.
Maltese: Meta tittieħed maċ-ċiklosporina (mediċina li tnaqqas l-attività tas-sistema immunitarja) id-doża ta' Ambrisentan Mylan għandha tkun 5 mg kuljum u l-pazjenti għandhom ikunu sorveljati mill-qrib mittabib tagħhom.
English: Ambrisentan Mylan is a medicine that is used alone or combined with other medicines to treat adults with pulmonary arterial hypertension (PAH).
Maltese: Ambrisentan Mylan huwa mediċina li tintuża waħidha jew flimkien ma' mediċini oħra għall-kura ta' adulti b'ipertensjoni arterjali pulmonari (PAH).
English: What are the benefits and risks of Ambrisentan Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Ambrisentan Mylan?
English: The company that markets Ambrisentan Mylan will provide a patient card containing important information on the medicine's side effects and the need to avoid pregnancy during treatment.
Maltese: Il-kumpanija li tqiegħed Ambrisentan Mylan fis-suq se tipprovdi kard tal-pazjenti li fiha informazzjoni importanti dwar l-effetti sekondarji tal-mediċina u l-ħtieġa li tiġi evitata t-tqala waqt il-kura.
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Maltese: Il-PAH hija pressjoni tad-demm anormalment għolja fl-arterji tal-pulmuni.
English: PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs.
Maltese: Il-PAH hija marda debilitanti fejn ikun hemm tidjiq serju tal-vażi tal-pulmuni.
English: Because Ambrisentan Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Ambrisentan Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The dose is increased to 10 mg daily when the medicine is used with tadalafil (another medicine for PAH).
Maltese: Id-doża tiżdied għal 10 mg kuljum meta l-mediċina tintuża ma' tadalfil (mediċina oħra għall-PAH).
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara ddokument bil-mistoqsijiet u t-tweġibiet hawnhekk.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Ilkumpanija wettqet ukoll studju li wera li huwa “bijoekwivalenti” għall-mediċina ta' referenza.
English: Ambrisentan Mylan is effective in PAH with no identified cause and in PAH caused by connective tissue disease.
Maltese: Ambrisentan Mylan huwa effettiv fil-PAH mingħajr kawża identifikata u fil-PAH ikkawżata minn marda tat-tessut konnettiv.
English: As for all medicines, data on the use of Ambrisentan Mylan are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ambrisentan Mylan hija ssorveljata kontinwament.
English: The active substance in Ambrisentan Mylan, ambrisentan, blocks the receptors (targets) for a hormone called endothelin, which causes blood vessels to become narrow.
Maltese: Is-sustanza attiva f'Ambrisentan Mylan, lambrisentan, timblokka r-reċetturi (miri) ta' ormon magħruf bħala endotelin, li jikkawża li l-vażi jidjiequ.
English: This means that Ambrisentan Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Volibris.
Maltese: Dan ifisser li Ambrisentan Mylan fih l-istess sustanza attiva u jaħdem bl-istess mod bħal "mediċina ta' referenza" diġà awtorizzata fl-UE imsejħa Volibris.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ambrisentan Mylan has been shown to have comparable quality and to be bioequivalent to Volibris.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Ambrisentan Mylan wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Volibris.
English: Ambrisentan Mylan is used in patients with class II or III disease.
Maltese: Ambrisentan Mylan jintuża f'pazjenti bil-marda tal-klassi II jew III.
English: How has Ambrisentan Mylan been studied?
Maltese: Kif ġie studjat Ambrisentan Mylan?
English: How does Ambrisentan Mylan work?
Maltese: Ambrisentan Mylan?