FrancophonIA/ELRC3.0 huggingface dataset:
English: darunavir/cobicistat (anti-HIV medicine) - carbamazepine, phenobarbital, phenytoin (medicines to prevent seizures) - rifampicin, because it is contraindicated with boosted protease inhibitors, and rifapentine
Maltese: HIV) - carbamazepine, phenobarbital, phenytoin (mediċini li jipprevjenu l-aċċessjonijiet). - rifampicin, minħabba li hu kontra-indikat flimkien ma' impedituri protease msaħħa, u rifapentine (mediċini li jitrattaw ċerti infezzjonijiet bħal tuberkolożi) - prodotti li fihom St John's wort (Hypericum perforatum) (prodott mill-ħxejjex li jintuża għad dipressjoni) - daclatasvir, simeprevir (mediċini biex jittrattaw infezzjoni tal-epatite Ċ).
English: Study was conducted with tenofovir disoproxil fumarate 300 mg once daily Note: In drug-drug interaction studies, different formulations and/or doses of etravirine were used which led to similar exposures and, therefore, interactions relevant for one formulation are relevant for the other.
Maltese: L-istudju sar b'tenofovir disoproxil fumarate 300 mg darba kuljum Nota: Fi studji dwar interazzjonijiet bejn mediċina u oħra, intużaw formulazzjonijiet u/jew dożi differenti ta' etravirine li wasslu għal espożizzjonijiet simili u, għalhekk, interazzjonijiet rilevanti għal formulazzjoni waħda huma rilevanti għal oħra.
English: INTELENCE is not a cure for HIV infection.
Maltese: INTELENCE m'huwiex kura għall-infezzjoni HIV.
English: Very rare side effects (may affect up to 1 in 10,000 people) - severe hypersensitivity reactions characterised by rash accompanied by fever and organ inflammation such as hepatitis.
Maltese: Effetti sekondarji rari ħafna (tista' taffettwa sa persuna waħda minn kull 10,000) - reazzjonijiet qawwija ta' sensittività eċċessiva kkaratterizzati minn raxx flimkien ma' deni u infjammazzjoni tal-organi bħal ma hija l-epatite.
English: Significantly fewer patients in the etravirine arm reached a clinical endpoint (AIDS-defining illness and/or death) as compared to the placebo arm (p = 0.0408).
Maltese: Għadd ferm inqas ta' pazjenti fil-fergħa ta' etravirine laħqu l-punt aħħari kliniku (mard li jfisser li hemm l-AIDS u/jew mewt) meta mqabbel mal-fergħa tal-plaċebo (p = 0.0408).
English: Rifampicin and rifapentine are expected to decrease plasma concentrations of etravirine.
Maltese: Rifampicin u rifapentine huma mistennija li jnaqqsu l-konċentrazzjonijiet filplażma ta' etravirine.
English: Each tablet contains 25 mg etravirine.
Maltese: Kull pillola fiha 25 mg etravirine
English: Skin and subcutaneous tissue disorders very common rash common night sweats, dry skin, prurigo uncommon angioneurotic oedema a, swelling face, hyperhidrosis rare
Maltese: Disturbi fil-ġilda u fittessuti ta' taħt il-ġilda komuni ħafna raxx komuni tgħereq ħafna matul il-lejl, ġilda xotta, prurigo mhux komuni edima anġionevrotika a, nefħa tal-wiċċ, iperidrożi rari
English: In rare instances, very serious rash has been reported which can be potentially life-threatening.
Maltese: F'każijiet rari, raxx serju ħafna kien irrapportat li jista' jkun ta' periklu għall-ħajja.
English: How to store INTELENCE
Maltese: X'fih INTELENCE:
English: Co-administration with medicinal products primarily metabolised by CYP2C9 or CYP2C19, or transported by P-glycoprotein, may result in increased plasma concentrations of such medicinal products, which could increase or prolong their therapeutic effect or alter their adverse events profile.
Maltese: Teħid flimkien ma' prodotti mediċinali metabolizzati primarjament minn CYP2C9 jew CYP2C19, jew ittrasportati permezz tal-glikoproteina P jistgħu jwasslu għal żieda filkonċentrazzjonijiet fil-plażma ta' dawn il-prodotti mediċinali, li jistgħu jżidu jew itawwlu l-effetti terapewtiċi tagħhom jew ibiddlu l-profil tar-reazzjonijiet avversi tagħhom.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Maltese: Għalkemm l-etjoloġija hija kkunsidrata bħala multifattorjali (inkluż użu ta' kortikosteroide, konsum tal-alkoħol, immunosoppressjoni qawwija, indiċi tal-massa tal-ġisem ogħla), każijiet ta' osteonekrożi ġew irrapportati partikolarment f'pazjenti bil-marda tal-HIV f'fażi avvanzata u/jew espożizzjoni fit-tul għal CART.
English: Concomitant use of PDE-5 inhibitors with INTELENCE may require dose adjustment of the PDE-5 inhibitor to attain the desired clinical effect.
Maltese: Bl-użu konkomittanti ta' impedituri ta' PDE-5 ma' INTELENCE jista' jkun hemm bżonn ta' aġġustament fid-doża tal-impeditur ta' PDE-5 sabiex jinkiseb l-effett kliniku mixtieq.
English: Etravirine had no effect on offspring development during lactation or post weaning at maternal exposures equivalent to those observed at the recommended clinical dose.
Maltese: Etravirine ma kellux effett fuq l-iżvilupp taż-żgħar waqt treddigħ jew wara ftim f'espożizzjonijiet materni ekwivalenti għal dawk osservati fid-doża klinika rrakkomandata.
English: Tel.: +48 22 237 60 00
Maltese: Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 00
English: AUC ↑ 3.10 (2.57-3.74) Cmin ↑ 5.27 (4.51-6.15) Cmax ↑ 1.77 (1.20-2.60) * compared to maraviroc 150 mg twice daily
Maltese: Cmax ↑ 1.77 (1.20-2.60) * meta mqabbel ma' maraviroc 150 mg darbtejn kuljum.
English: AUC ↔ 1.03 (0.90-1.18) Cmin ↓ 0.87 (0.75-1.02) Cmax ↔ 1.06 (0.95-1.20) etravirine
Maltese: 87 (0.75-1.02) Cmax ↔ 1.06 (0.95-1.20) etravirine
English: All ranges
Maltese: U KWANTITATTIVA
English: 200 mg twice daily eight 25 mg tablets twice daily or two 100 mg tablets twice daily or one 200 mg tablet twice daily
Maltese: 200 mg darbtejn kuljum tmien pilloli ta' 25 mg darbtejn kuljum jew żewġ pilloli ta'100 mg darbtejn kuljum jew pillola waħda ta' 200 mg darbtejn kuljum
English: INTELENCE is used in combination with other anti-HIV medicines to treat adults and children 6 years of age and older who are infected by HIV and who have used other anti-HIV medicines before.
Maltese: INTELENCE jintuża f'kombinazzjoni ma' mediċini oħrajn kontra l-HIV sabiex jittratta adulti u tfal li għandhom eta' ta' 6 snin jew iktar infettati bl-HIV u li użaw mediċini oħrajn kontra l-HIV qabel.
English: INTELENCE and didanosine can be used without dose adjustments.
Maltese: INTELENCE u didanosine jistgħu jintużaw mingħajr aġġustamenti fid-doża.
English: No data other than drug-drug interaction data (see section 4.5) are available when etravirine is combined with raltegravir or maraviroc.
Maltese: M'hemmx informazzjoni disponibbli ħlief tagħrif dwar interazzjonijiet bejn il-mediċini (ara sezzjoni 4.5) meta etravirine huwa kkombinat ma' raltegravir jew maraviroc.
English: ATCvet code: QI01AD.
Maltese: QI01AD.
English: Date of first authorisation: 08/09/2015
Maltese: Data tal-ewwel awtorizazzjoni: 08/09/2015
English: SC or in-ovo use.
Maltese: SC jew in-ovo.
English: Casein hydrolisate Sorbitol
Maltese: Kaseina Idrolisate Sorbitol
English: 2,500 - 8,000 PFU*
Maltese: 8,000 PFU*/doża
English: Store below 25°C.
Maltese: Aħżen f'temperatura inqas minn 25°C.
English: Store below 25 °C.
Maltese: Aħżen f'temperatura inqas minn 25 °C.
English: Store and transport frozen in liquid nitrogen (-196 °C).
Maltese: Aħżen u ttrasporta ffriżat fin-nitroġenu likwidu (-196 °C).
English: L-glutamine Sodium bicarbonate Hepes
Maltese: L-glutamina Bikarbonat tas-sodju Hepes
English: For in-ovo administration:
Maltese: Għal amministrazzjoni in-ovo:
English: EXP {month/year}
Maltese: EXP{xahar/sena}
English: Dipotassium hydrogen phosphate Potassium dihydrogen phosphate Phenol red
Maltese: Idroġenufosfat tad-dipotassju Diidroġenufosfat tal-potassju Phenol aħmar
English: Bovine serum Dimethyl sulfoxide Water for injection
Maltese: Serum tal-bovini Dimethyl sulfoxide
English: Solvent presentation (ml)
Maltese: Preżentazzjoni tas solvent (ml)
English: Each dose of reconstituted vaccine (0.05 ml in-ovo or 0.2 ml subcutaneous) contains:
Maltese: Kull doża tal-vaċċin rikostitwit (0.05 ml in-ovo jew 0.2 ml taħt il-ġilda) fiha:
English: Overview table for dilution possibilities of different presentations:
Maltese: Tabella ta' ħarsa ġenerali għal possibbiltajiet ta' dilwizzjoni ta' preżentazzjonijiet differenti:
English: Sterile solvent
Maltese: Solvent sterili
English: Cell-associated live recombinant viral turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle disease virus D-26 lentogenic strain: 2,500-8,000 PFU*/dose
Maltese: Vajrus tal-herpes rikombinanti attiv tad-dundjani assoċjat maċ-ċelloli (rHVT/ND) li jesprimi lproteina ta' fużjoni tal-istrejn lentoġeniku tal-vajrus (D-26) tal-marda Newcastle: 2,500 - 8,000 PFU*
English: Vectormune ND suspension and solvent for suspension for injection for chickens
Maltese: Vectormune ND suspensjoni u solvent għal suspensjoni għal injezzjoni għat-tiġieġ
English: Repeat the operations in point 2-7 for the appropriate number of ampoules to be thawed.
Maltese: Irrepeti l-operazzjonijiet f'punt 2-7 għan numru xieraq ta' ampulletti li jridu jiġu mdewba.
English: Orange-yellowish semi-transparent frozen suspension.
Maltese: Suspenzjoni ffriżata semitrasparenti safranija fl-oranġjo.
English: Draw up 2 ml of sterile solvent into a 5 ml syringe then draw up the thawed content of Vectormune ND ampoule in it.
Maltese: Iġbed 2 ml ta' solvent sterilizzat f'siringa tal-5 ml u mbagħad iġbed il-kontenut imdewweb ta' Vectormune ND ampolla fiha.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: mhijiex fl-iskop tar-Regolament tal-Kummissjoni (UE) Nru 470/2009.
English: PACKAGE LEAFLET: Vectormune ND suspension and solvent for suspension for injection for chickens
Maltese: VETERINARJU Vectormune ND suspensjoni u solvent għal suspensjoni għal injezzjoni għat-tiġieġ
English: Suspension and solvent for suspension for injection.
Maltese: Suspensjoni u solvent għal suspensjoni għal injezzjoni.
English: The mixed products protect against Newcastle disease virus, Marek's disease virus with a phenotype “virulent” and Avian Infectious Bursal Disease (IBD) viruses.
Maltese: Il-prodotti mħallta jipproteġu kontra l-virus tal-marda Newcastle, il-virus tal-marda Marek bil-finotip “virulenti” u l-virus tal-marda infettiva Avjan
English: HUNGARY
Maltese: L-UNGERIJA
English: The speed of automatic injection is at least 2,500 eggs per hour, therefore solvent presentation of at least or more than 400 ml is recommended to prime and inject for longer than 10 minutes.
Maltese: Il-veloċità tal-injezzjoni awtomatika hija ta' mill-inqas 2,500 bajda kull siegħa, għalhekk il preżentazzjoni tas-solvent ta' mill-inqas 400 ml jew aktar hija rakkomandata biex tipprajmja u tinjetta għal aktar minn 10 minuti.
English: Company logo or
Maltese: logo jew
English: Draw up 2 ml of solvent into a 5 ml syringe.
Maltese: Iġbed 2 ml ta' solvent għal ġo siringa ta' 5 ml.
English: Sucrose
Maltese: KWANTITÀ
English: Solvent: Polyvinylchloride bag containing 200 ml, 400 ml or 800 ml in individual over-pouch.
Maltese: Borża tal-polyvinylchloride li jkun fiha 200 ml, 400 ml jew 800 ml f'over-pouch individwali.
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, il pussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Suspension: EMEM
Maltese: EMEM
English: Glass ampoule of 1,000; 2,000 or 4,000 doses of the vaccine.
Maltese: IEĦOR Ampullett tal-ħġieġ li jkun fih 1,000, 2,000 jew 4,000 doża tal-vaċċin.
English: The vaccine strain was shown to be excreted by chickens and there was a slow spread to turkeys which was not detectable at 35 days but was detectable after 42 days of a contact study.
Maltese: Tixrid bil-mod għad-dundjani fejn li ma kienx identifikabbli f'35 ġurnata iżda kien identifikabbli wara 42 ġurnata ta' studju ta' kuntatt.
English: For active immunisation of 18 day-old embryonated chicken eggs or one-day-old chicks to reduce mortality and clinical signs caused by Newcastle disease virus and to reduce mortality, clinical signs and lesions caused by Marek's disease virus with a phenotype “virulent”.
Maltese: Għal immunizzazzjoni attiva tal-bajd tat-tiġieġ embrijonat ta' 18-il ġurnata jew flieles ta' ġurnata biex tnaqqas l-imwiet u sinjali kliniċi kkawżati mill-vajrus tal-marda Newcastle u biex tnaqqas l-imwiet, sinjali kliniċi u leżjonijiet kkawżati mill-vajrus tal-marda ta' Marek bil-finotip “virulenti”.
English: Be familiar with all safety and precautionary measures for handling liquid nitrogen in order to prevent personal injury.
Maltese: Kun familjari mal-miżuri ta' sigurtà u ta' prekawzjoni kollha għall-immaniġġjar tan-nitroġenu likwidu sabiex tevita korriment personali.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inklużi l-adjuvanti) elenkati f'sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il prodott mediċinali veterinarju
English: The usual aseptic precautions should be applied to all administration methods.
Maltese: Applika l-prekawzjonijiet assettiċi tas-soltu għall-metodi kollha ta' amministrazzjoni.
English: Read the package leaflet before use.
Maltese: Mhux id-daqsijiet kollha tal-pakketti jistgħu jkunu fis-suq.
English: Type I glass ampoule containing 1,000, 2,000 or 4,000 doses of the vaccine.
Maltese: Ampullett tal-ħġieġ tat-tip I li jkun fih 1,000, 2,000 jew 4,000 doża tal-vaċċin.
English: Pharmacotherapeutic group: Immunologicals for Aves, live viral vaccines for domestic fowls.
Maltese: Immunoloġiċi għal Aves, vaċċini virali ħajjin għal tjur domestiċi.
English: (ml)
Maltese: Ltd.
English: Cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain:
Maltese: Vajrus tal-herpes rikombinanti attiv tad-dundjani assoċjat maċ-ċelloli (rHVT/ND) li jesprimi l-proteina ta' fużjoni tal-istrejn lentoġeniku tal-vajrus (D-26) tal-mard Newcastle: 2,500
English: Once the ampoule is open, slowly draw up the content into the 5 ml sterile syringe already containing 2 ml of solvent with a needle of at least 18 gauge diameter.
Maltese: Ladarba l-ampullett jinfetaħ, iġbed bil-mod il-kontenut tiegħu f'siringa sterilizzata ta' 5 ml li diġà jkun fiha 2 ml ta' solvent b'labra ta' dijametru ta' mill-inqas 18 gejġ.
English: Thaw rapidly the contents of the ampoules by gentle agitation in water at 27-39 °C.
Maltese: Dewweb il-kontenut tal-ampulletti malajr billi tħawwad bil-mod fl-ilma f'temperatura ta' bejn 27oC - 39oC.
English: 400 ml
Maltese: 4,000 doża
English: Once the ampoule is open slowly draw up the content into the 5 ml sterile syringe already containing 2 ml solvent with a needle of at least 18 gauge diameter.
Maltese: Ladarba l-ampullett jinfetaħ, iġbed bil-mod il-kontenut tiegħu f'siringa sterilizzata ta' 5 ml li diġà jkun fiha 2 ml ta' solvent b'labra ta' dijametru ta' mill-inqas 18G.
English: Do not mix with any other veterinary medicinal product, except Cevac Transmune (where it is marketed) and the solvent (Cevac Solvent Poultry) supplied for use with the veterinary medicinal product.
Maltese: Tħallatx ma' kwalunkwe prodott mediċinali veterinarju ieħor, minbarra Cevac Transmune (fejn dan huwa kummerċjalizzat) u s-solvent (Cevac Solvent Poultry) forniti għall-użu mal-prodott mediċinali veterinarju.
English: 200 ml
Maltese: 2,000 doża
English: Solvent presentation smaller than 400 ml are not recommended to be used for in-ovo application by an automated machine as it may not be enough to prime the machine and to inject for longer than 10 minutes.
Maltese: Preżentazzjoni tas-solvent inqas minn 400 ml mhijiex rakkomandata għall-użu f'applikazzjoni in-ovo permezz ta' magna awtomizzata peress li din tista' ma tkunx biżżejjed biex tipprajmja l-magna u tinjetta għal aktar minn 10 minuti.
English: For inovo application an automatic in-ovo egg injector can be used.
Maltese: Għal applikazzjoni in-ovo jista' jintuża injettur tal-bajd awtomatiku in-ovo.
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 ilMediċini (http://www.ema.europa.eu/).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE OR OUTER PACKAGES Solvent bags of 200 ml, 400 ml or 800 ml
Maltese: Boroż tas-solvent ta' 200 ml, 400 ml jew 800 ml
English: Transfer the suspension into the solvent bag.
Maltese: Ittrasferixxi s-suspensjoni għal ġol-borża tas-solvent.
English: The efficacy of the vaccine was challenged with the Marek virus strain MD70 which has a phenotype “virulent”.
Maltese: L-effikaċja tat-tilqima ġiet sfidata bir-razza tal-virus ta' Marek MD70 li għandha l-finotip “virulenti”.
English: The canes with ampoules are stored in a liquid nitrogen container.
Maltese: ampulletti meħtieġa mill-kontenitur tan-nitroġenu likwidu.
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: U/JEW UŻU Kull persuna li tkun bi ħsiebha timmanifattura, timporta, tippossjedi, tbigħ, tforni u tuża dan il-prodott mediċinali veterinarju għanda l-ewwel tikkonsulta mal-awtorità kompetenti tal-Istat Membru relevanti dwar il-politika ta' tilqim kurrenti, peres li dawn l-attivitajiet jistgħu jkunu pprojbiti f'parti tat-territorju jew kollu ta' Stat Membru skont il-leġislazzjoni nazzjonali.
English: In-ovo equipment should be calibrated to ensure that a 0.05 ml dose is applied to each egg.
Maltese: Tagħmir in-ovo għandu jiġi kalibrat sabiex ikun żgurat li qed tiġi applikata doża ta' 0.05 ml lil kull bajda.
English: Preparation of vaccine suspension for injection:
Maltese: Preparazzjoni tas-suspensjoni tal-vaċċin għal injezzjoni:
English: Onset of immunity against Newcastle disease for broilers and layers: 3 weeks of age.
Maltese: Tul ta' żmien ta' immunità kontra l-marda Newcastle għal tiġieġ tas-simna: ta' disa' ġimgħat.
English: Solvent presentation smaller than 400 ml is not recommended to be used for in-ovo application as it may not be enough to prime the machine and to inject longer than 10 minutes.
Maltese: Preżentazzjoni tas-solvent inqas minn 400 ml mhijiex rakkomandata għall-użu f'applikazzjoni in-ovo peress li din tista' ma tkunx biżżejjed biex tipprajmja l-magna u tinjetta għal aktar minn 10 minuti.
English: Polyvinylchloride bag containing 200 ml of solvent in individual over-pouch.
Maltese: Borża tal-polyvinylchloride li jkun fiha 200 ml f'over-pouch individwali.
English: Personal protective equipment consisting of protective gloves, spectacles and boots should be worn when handling the veterinary medicinal product, before withdrawing from liquid nitrogen, during the ampoule thawing and opening operations.
Maltese: Waqt li tuża dan il-prodott mediċinali veterinarju għandu jintlibes tagħmir personali protettiv li jikkonsisti f'ingwanti protettivi, nuċċali u bwiez, qabel ma tieħu min-nitroġenu likwidu, waqt li lkontenut tal-ampullett ikun qed idub u waqt li qed tiftaħ il-prodott.
English: It should be ensured that the vaccine suspension is mixed regularly in a gentle way during the vaccination session to guarantee that the vaccine suspension remains homogenous and that the correct vaccine virus titer is administered (e.g. when automatic in-ovo injection machines are used or during long vaccination sessions).
Maltese: Għandu jiġi żgurat li s-suspensjoni tal-vaċċin titħallat regolarment bil-mod matul is-sessjoni tat-tilqim sabiex jiġi garantit li s-suspensjoni tal-vaċċin tibqa' omoġena u li jiġi amministrat it-titru korrett talvajrus tal-vaċċin (eż. meta jintużaw magni ta' injezzjoni in-ovo awtomatiċi jew matul sessjonijiet twal ta' tilqim).
English: Polyvinylchloride bag containing 800 ml of solvent in individual over-pouch.
Maltese: Borża tal-polyvinylchloride li jkun fiha 800 ml f'over-pouch individwali.
English: Safety trials show the excreted vaccine strain is not harmful in turkeys; however, special precautions should be taken to avoid spreading of the vaccine strain to turkeys.
Maltese: Provi kliniċi ta' sigurtà juru li l-istrejn tal-vaċċin li joħroġ bħala eskrement ma jagħmilx ħsara lid-dundjani; madankollu, għandhom jittieħdu prekawzjonijiet speċjali biex jiġi evitat it-tixrid tal istrejn tal-vaċċin għad-dundjani.
English: Store and use liquid nitrogen only in a dry and well-ventilated place.
Maltese: Aħżen u uża n-nitroġenu likwidu f'post xott u ventilat.
English: Polyvinylchloride bag containing 400 ml of solvent in individual over-pouch.
Maltese: Borża tal-polyvinylchloride li jkun fiha 400 ml f'over-pouch individwali.
English: As soon as they are completely thawed, open ampoules holding them at arms length in order to prevent any risk of injury should the ampoule break.
Maltese: Armi dawk l-ampulletti li ġew imdewba bi żball.
English: One single injection of 0.05 ml is applied to each 18day-old embryonated broiler chicken egg.
Maltese: Injezzjoni waħda ta' 0.05 ml hija injettata f'kull bajda embrijonata ta' tiġieġ tas-simna ta' 18-il ġurnata.
English: Chickens and embryonated chicken eggs
Maltese: TA' PRODOTTI MHUX
English: Procedure for preparing vaccine suspension:
Maltese: Proċedura għall-preparazzjoni tas-suspenzjoni tal-vaċċin:
English: One single dose of 0.05 ml is injected into each 18-day-old embryonated broiler chicken egg.
Maltese: Injezzjoni waħda ta' 0.05 ml hija injettata f'kull bajda embrijonata ta' tiġieġ tas-simna 18-il ġurnata.
English: 1,000 doses 2,000 doses 4,000 doses
Maltese: Ampulletti ta' 1,000, 2,000 jew 4,000 doża ISEM
English: In-ovo and subcutaneous use.
Maltese: Użu in-ovo u taħt il-ġilda.
English: Draw up 2 ml of sterile solvent into another 5 ml syringe then dissolve the content of Cevac Transmune vial in it.
Maltese: Iġbed 2 ml ta' solvent sterili f'siringa oħra tal-5 ml u mbagħad ħoll il-kontenut tal-kunjett Cevac
English: Read also the product information of Cevac Transmune before use.
Maltese: Aqra wkoll l-informazzjoni tal-prodott ta' Cevac Transmune qabel l-użu.
English: Duration of immunity against Newcastle disease for layers: 18 weeks of age
Maltese: Tul ta' żmien ta' immunità kontra l-marda ta' Newcastle għal tiġieġ tal-bajd: ta' 18-il ġimgħa
English: Duration of immunity for broilers and layers: A single vaccination is sufficient to provide protection during the risk period of infection with Marek's disease virus with a phenotype “virulent”.
Maltese: Tilqima waħda hija biżżejjed biex tagħti protezzjoni waqt il-perjodu ta' riskju ta' infezzjoni bil-marda ta' Marek.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/165563/2018 EMEA/H/C/000332
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 ta' Marzu 2018 EMA/165563/2018 EMEA/H/C/000332
English: Further information on Aranesp's current uses 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: It contains the active substance darbepoetin alfa.
Maltese: Huwa fih is-sustanza attiva darbepoetina alfa.
English: What is Aranesp?
Maltese: Kif jaħdem Aranesp?