FrancophonIA/ELRC3.0 huggingface dataset:
English: Women taking Tyverb with trastuzumab lived without their disease getting worse for 12.0 weeks on average, compared with 8.1 weeks in those taking Tyverb alone.
Maltese: Innisa li kienu qegħdin jieħdu Tyverb ma' trastuzumab għexu għal medja ta' 12.0-il ġimgħa mingħajr ma lmarda tagħhom marret għall-agħar, meta mqabbla ma' 8.1 ġimgħat f'dawk li kienu qegħdin jieħdu Tyverb waħdu.
English: Portugal capsule
Maltese: Portugal kapsula
English: Lemesos 3501
Maltese: Street Lemesos 3501
English: Benzstraße 1
Maltese: KG Benzstraße 1
English: Castilla 2, Edificio Berlín 2ª planta Parque Empresarial San Fernando
Maltese: Edificio Berlín 2ª planta Parque Empresarial San Fernando
English: Unit 34/35, Block A Dunboyne Business Park Dunboyne
Maltese: Unit 34/35, Block A Dunboyne Business Park Dunboyne Co. Meath Ireland
English: Sopharma AD 16"Iliensko shose" Str. Sofia
Maltese: Sopharma AD 16"Iliensko shose" Str.
English: Meda AS, Askerveien 61, Postboks 194, 1371 Asker
Maltese: Meda AS Askerveien 61 Postboks 194 1371 Asker Norway
English: Benzstr.
Maltese: KG Benzstr.
English: MEDA PHARMACEUTICALS S.A., GREECE 3 Evrytanias Str., Halandri, 15231, Attiki, Greece
Maltese: 3 Evrytanias Str., Halandri 15231, Attiki
English: Belgium Meda Pharma s.a. Chaussée de la Hulpe 166 1170 Brussels
Maltese: Chaussée de la Hulpe 166 1170 Brussels Belgium
English: 170 09 Solana Box 906
Maltese: 170 09 Solna Box 906
English: Maksimirska 120/V, Zagreb
Maltese: Maksimirska 120/V Zagreb 10 000 Croatia
English: Medochemie Ltd Constantinoupoleos 1-10 Street
Maltese: Medochemie Ltd Constantinoupoleos 1-10
English: Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Maltese: Il-Ġermanja ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Czech Republic Medochemie Ltd. Konstantinoupoleos Str. 1_10 3011 Limassol - Tsiflikoudia Cyprus
Maltese: Constantinoupoleos Str. 1_10 3011 Limassol - Tsiflikoudia Cyprus
English: Parlodel 10 mg 10 mg
Maltese: Parlodel 10 mg
English: Gedeon Richter Plc Gyömrői út 19-21.
Maltese: Gedeon Richter Plc Gyömrői út 19-21 H-1103 Budapest Hungary
English: S.C. BIOFARM S.A. Str. Logofăt Tăutu nr. 99, sector 3,
Maltese: Logofăt Tăutu nr. 99 sector 3, Bucureşti
English: Bromocriptin AbZ 2,5 mg
Maltese: Bromocriptin AbZ 2,5 mg 2.5 mg
English: Lek farmacevtska družba d.d.,
Maltese: Lek farmacevtska družba d.d. Verovškova 57
English: Germany betapharm Arzneimittel GmbH
Maltese: Il-Ġermanja betapharm Arzneimittel GmbH Kobelweg 95
English: Meda AS, Solvang 8, DK-3450 Allerød, Denmark
Maltese: DK-3450 Allerød Denmark
English: 89079 Ulm germany bromocriptin-ct 2,5mg Tabletten
Maltese: Industriestr. 25 83607 Holzkirchen Germany bromocriptin-ct 2,5mg Tabletten
English: MEDA PHARMA 25, boulevard de l'Amiral Bruix,
Maltese: 25, boulevard de l'Amiral Bruix 75016 Paris
English: Slovak Republic MEDA Pharma s.r.o.
Maltese: MEDA Pharma s.r.o.
English: MEDA PHARMA, S.A.U.
Maltese: MEDA PHARMA, S.
English: United Kingdom Teva UK Limited, Brampton Road,
Maltese: Teva UK Limited Brampton Road, Hampden Park Eastbourne, East Sussex BN22 9AG
English: Parlodel 5mg Tablets capsule
Maltese: Parlodel 5mg Tablets kapsula
English: BROMOCRIPTINRICHTER
Maltese: BROMOCRIPTIN
English: Luxembourg MEDA Pharma GmbH & Co. KG
Maltese: Il-Lussemburgu MEDA Pharma GmbH & Co.
English: Parlodel 10mg Tablets capsule
Maltese: Parlodel 10 mg Tablets kapsula
English: Bromocriptinratiopharm 2,5mg Tabletten
Maltese: Bromocriptin-ratiopharm 2,5mg Tabletten
English: Pravidel 2,5 mg Tabletten
Maltese: Pravidel 2,5 mg Tabletten 2.5 mg
English: Parlodel 2,5 mg 2.5 mg
Maltese: Parlodel 2,5 mg
English: Bromergon 2,5 mg tablete
Maltese: Bromergon 2,5 mg tablete 2.5 mg
English: BromocriptinRichter 2,5 mg tabletta
Maltese: Bromocriptin-Richter 2,5 mg tabletta
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for bromocriptine-containing medicinal products indicated in the “prevention or suppression of physiological lactation in the immediate post-partum period and in the late post-partum period”
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: Industriestr.
Maltese: S.A.
English: Verovškova 57, 1000 Ljubljana, Slovenia
Maltese: 1526 Ljubljana
English: BROMOCRIPTIN 2.5 mg coated tablet
Maltese: Bromocriptine 2.5 mg Tablets 2.5 mg
English: 75016 Paris
Maltese: Sofia 1220
English: 16 December 2016 EMA/822769/2016 EMEA/H/C/004342
Maltese: EMA/822769/2016 EMEA/H/C/004342
English: Withdrawal of the marketing authorisation application for Cavoley (pegfilgrastim) EMA/822769/2016
Maltese: (pegfilgrastim) EMA/822769/2016
English: Filgrastim is very similar to a human protein called
Maltese: Filgrastim huwa simili ħafna għal proteina tal
English: Cavoley was developed as a ‘biosimilar' medicine.
Maltese: Cavoley ġie żviluppat bħala mediċina ‘bijosimili'.
English: On 16 November 2016, Gedeon Richter Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cavoley, for reducing neutropenia.
Maltese: Fis-16 ta' Novembru 2016, Gedeon Richter Plc għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Cavoley, għat-tnaqqis tan-newtropenja.
English: What is Cavoley?
Maltese: X'inhu Cavoley?
English: granulocyte-colony-stimulating factor (G-CSF).
Maltese: bniedem imsejħa fattur li jistimula l-kolonji ta' granuloċiti (G-CSF).
English: The active substance in Cavoley, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Maltese: Is-sustanza attiva f'Cavoley, il-pegfilgrastim, hija magħmula minn filgrastim li jkun ġie ‘pegilat' (imwaħħal ma' sustanza kimika msejħa glikol politin).
English: Cavoley is a medicine that contains the active substance pegfilgrastim, which stimulates the production of neutrophils (a type of white blood cell that fights infections).
Maltese: Cavoley huwa mediċina li fiha s-sustanza attiva pegfilgrastim, li tistimula l-produzzjoni ta' newtrofili (tip ta' ċellola bajda tad-demm li tiġġieled l-infezzjonijiet).
English: What was Cavoley expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Cavoley?
English: Withdrawal of the marketing authorisation application for Cavoley (pegfilgrastim)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Cavoley (pegfilgrastim)
English: The company presented results of studies in healthy people designed to show that Cavoley is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Maltese: Il-kumpanija ppreżentat riżultati ta' studji ta' persuni b'saħħithom imfassla sabiex juru li Cavoley huwa simili għall-mediċina ta' referenza tiegħu Neulasta f'termini ta' struttura kimika, purità, il-mod kif jaħdem u l-mod kif il-ġisem juża l-mediċina.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Cavoley could not have been approved for reducing neutropenia.
Maltese: Fuq il-bażi tar-reviżjoni tad-data u t-tweġibiet tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fiżżmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-idea provviżorja li Cavoley ma setax jiġi approvat għat-tnaqqis ta' newtropenja.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for Cavoley.
Maltese: Il-kumpanija infurmat lis-CHMP li ma hemm ebda prova klinika għaddejja jew programm ta' użu b'kumpassjoni għal Cavoley.
English: This means that Cavoley was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union called Neulasta.
Maltese: Dan ifisser li Cavoley kien intiż li jkun simili ħafna għal mediċina bijoloġika (il-‘mediċina ta' referenza') li diġà tinsab awtorizzata fl-Unjoni Ewropea msejħa Neulasta.
English: A further study in patients receiving cancer medicines compared the safety and effectiveness of Cavoley and Neulasta.
Maltese: Studju ieħor fuq pazjenti li kienu qegħdin jirċievu mediċini tal-kanċer qabbel is-sigurtà u l-effikaċja ta' Cavoley u Neulasta.
English: Store below 25 °C.
Maltese: Aħżen taħt il 25° C.
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Maltese: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Franza
English: 2,500 doses
Maltese: 2.500 doża
English: ATCvet code: QI01BD03.
Maltese: Q101BDO3.
English: Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dehydrate Water for injections.
Maltese: Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dehydrate Ilma għal injezzjoni
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/04/2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 11/04/2014
English: PACKAGE SIZE 10 x 500 doses 1x 2,500 doses
Maltese: DAQS TAL-PAKKETT 10 x 500 doża 1 x 2,500 doża
English: Muscovy ducks.
Maltese: Papri Muscovy
English: - Second vaccination: at 17 days of age.
Maltese: - It-tieni tilqima : fl-età ta' 17 il-ġurnata.
English: PACKAGE SIZE 500 doses.
Maltese: DAQS TAL-PAKKETT 500 doża.
English: Store and transport refrigerated (2° C - 8° C).
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C).
English: MARKETING AUTHORISATION NUMBERS EU/2/14/162/001-002
Maltese: FIS-SUQ EU/2/14/162/001-002
English: STATEMENT OF ACTIVE SUBSTANCES Saline buffer
Maltese: DIKJARAZZJONI TAS-SUSTANZI ATTIVI Saline buffer
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: live viral vaccines, duck parvovirus.
Maltese: Grupp farmako-terapewtiku: vaċċini virali ħajja, parvovirus fil-papri.
English: 6.2 Major incompatibilities
Maltese: .2 Inkompatibilitajiet Maġġuri
English: Do not use in birds in lay (see section 4.3).
Maltese: Tużax fi tjur li qed ibidu (ara sezzjoni 4.3).
English: Concentrate:
Maltese: Konċentrat :
English: Manufacturer responsible for batch release: MERIAL
Maltese: Manifattur responsabbli għall-ħrug tal-lott: MERIAL
English: Live attenuated Muscovy duck parvovirus strain GM 199 .................................... 2.6-4.8 log10 CCID50.
Maltese: Parvovirus ħaj imdgħajjef tal-papra Muscovy strejn GM 199 ............................... 2.6-4.8 log10 CCID50.
English: Polypropylene bags with butyl elastomer closure and trocar.
Maltese: Boroż tal-polypropylene b'għeluq tal-butyl elastomer u trocar.
English: Antigen Concentrate:
Maltese: Konċentrat tal-antiġen:
English: Live attenuated Muscovy duck parvovirus strain GM 199 ...................... 2.6-4.8 log10 CCID50* * Cell culture infectious dose 50%.
Maltese: Il-parvovirus ħaj imdgħajjef tal-papra Muscovy strejn GM199 ......................... 2.6 - 4.8 log10 CCID50* Doża infettiva ta' kultura ta' ċelloli 50%
English: Due to the limited period the veterinary medicinal product Parvoduk has been placed on the market and the consequently limited post-marketing safety information, the CVMP at their meeting on 6-8 November 2018 decided that one five-year renewal is required.
Maltese: Minħabba l-perjodu limitat li fih l-prodott veterinarju mediċinali Parvoduk tqiegħed fuq is-suq u minħabba li l-informazzjoni tas-sigurtà wara t-tqegħid fis-suq hija konsegwentement limitata, ilKumitat CVMP waqt il-laqgħa tas-6 - 8 ta' Novembru 2018 iddeċieda li hemm ħtieġa ta' tiġdid wieħed ta' ħames snin.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Solvent for Parvoduk concentrate
Maltese: VETERINARJU Solvent għall-konċentrat tal-Parvoduk.
English: ANNEX IV GROUNDS FOR ONE ADDITIONAL RENEWAL
Maltese: ANNESS IV RAĠUNIJIET GĦAL TIĠDID ADDIZZJONALI WIEĦED
English: Detailed information of 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 veterinarju mediċinali tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: Do not freeze.
Maltese: Neħħi t-trocar.
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: Is-sustanza attiva peres li hija ingredjent ta' oriġini bijoloġika intiża biex tipproduċi immunità attiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: PHARMACEUTICAL FORM Concentrate for suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Konċentrat għal suspensjoni għal injezzjoni.
English: PHARMACEUTICAL FORM Concentrate and solvent for suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Konċentrat u solvent għal suspensjoni għal injezzjoni.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji ta' kompatibilità, dan il-prodott veterinarju mediċinali m'ghandux jitħallat ma ebda prodotti mediċinali veterinarji oħra.
English: C T C G C C C A A T A The vaccine strain can be found in the spleen for at least 35 days.
Maltese: A G T C T A T C G A G Parvovirus tal-papra C A C G C C C A A C A Parvovirus tal-wiżż C T C G C C C A A T A L-istrejn tal-vaċċin jista' jinsab fil-milsa għal mill-inqas 35 ġurnata.
English: The excipients 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 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 għandhom jiġu 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: The concentrate is opalescent and homogeneous.
Maltese: Il-konċentrat huwa opalexxenti u omoġenu.
English: Active immunisation of Muscovy ducks to reduce weight loss and lesions of Muscovy duck parvovirosis and Derzsy's disease and, in the absence of maternally derived antibodies, to also prevent mortality.
Maltese: Immunizzazzjoni attiva ta' papri Muscovy biex tnaqqas telf ta' piż u leżjonijiet tal-virus tal-papri Muscovy u l-Marda Derzsy u, fin-nuqqas ta' antikorpi derivati mill-omm, biex tevita wkoll ilmortalità.
English: Eleven genetic markers (nucleotides) in the VP1 gene allow differentiation of the Parvoduk vaccine strain from the field strains of duck and goose parvovirus, as shown below:
Maltese: Ħdax-il marker ġenetiku (nukleotidi) fil-ġene VPI jippermettu differenzjar tal-istrejn tal-vaċċin talParvoduk mill-istrejnijiet li jinstabu barra tal-parvovirus tal-papri u tal-wiżż, kif jigi muri hawn taħt:
English: MARKETING AUTHORISATION NUMBERS EU/2/14/162/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/2/14/162/001
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each reconstituted dose of 0.2 ml contains:
Maltese: Kull doża rikostitwita ta' 0.2 ml fiha:
English: It induces an active and specific immunity against Muscovy duck parvovirosis and Derzsy's disease in the vaccinated birds.
Maltese: Jinduċi immunità attiva u speċifika kontra lparvovirus tal-papra Muscovy u l-marda ta' Derzsy fit-tjur imlaqqma.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk solvent for suspension for injection for Muscovy ducks
Maltese: VETERINARJU Parvoduk solvent għal suspensjoni għal injezzjoni għal papri Muscovy.
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 turi l-intenzjoni li timmanifattura, timporta, tippossjedi, tbigħ, tipprovdi u tuża dan ilprodott veterinarju mediċinali għandha l-ewwel tikkonsulta mal-Awtorità Kompetenti tal-Istat Membru dwar il-programmi ta' tilqim kurrenti peress li dawn l-attivitajiet jistgħu jkunu projbiti fi Stat Membru fit-territorju kollu tiegħu jew f'parti minnu taħt leġislazzjoni nazzjonali.
English: 4.2 Indications for use, specifying the target species Active immunisation of Muscovy ducks to reduce weight loss and lesions of Muscovy duck parvovirosis and Derzsy's disease and, in the absence of maternally derived antibodies, to also prevent mortality.
Maltese: .2 Indikazzjonijiet għal użu tal-prodott li jispeċifikaw l-ispeċi li fuqhom se jintuża l-prodott Immunizzazzjoni attiva ta' papri Muscovy biex tnaqqas telf ta' piż u leżjonijiet tal-virus tal-papri Muscovy u tal-Marda Derzsy u, fin-nuqqas ta' antikorpi derivati mill-omm, biex tevita wkoll ilmortalità.
English: Onset of immunity: 11 days after the primary vaccination course
Maltese: Bidu tal-immunità: 11-il ġurnata wara l-ewwel kors ta' tilqim.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Live attenuated Muscovy duck parvovirus.
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Parvovirus ħaj imdgħajjef tal-papra Muscovy.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i)
English: Cardboard box of 10 vials of 500 doses.
Maltese: Kaxxa tal-kartun li fiha 10 boroż ta' 500 doża.
English: TARGET SPECIES Muscovy ducks.
Maltese: HUWA INDIKAT IL-PRODOTT Papri Muscovy.
English: Transfer the content of the glass vial into the bag of solvent.
Maltese: Ittrasferixxi l-kontenut tal-kunjett fil-borża tas-solvent .
English: One reconstituted dose of 0.2 ml contains:
Maltese: Doża waħda rikostitwita ta' 0.2 ml fiha:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk concentrate and solvent for suspension for injection for Muscovy ducks
Maltese: VETERINARJU Parvoduk konċentrat u solvent għal suspensjoni għal injezzjoni għal papri Muscovy.
English: No adverse reactions were observed after the administration of an overdose (10 x the dose).
Maltese: L-ebda effetti mhux mixtieqa ma ġew osservati meta ngħatat doża eċċessiva (10 x id-doża).
English: Type I glass vials with butyl elastomer closure.
Maltese: Kunjetti tal-ħġieġ tat-Tip I b'għeluq tal-butyl elastomer.
English: Position on VP1 gene
Maltese: Pożizzjoni fuq ilġene VP1
English: The vaccine contains a live attenuated Muscovy duck parvovirus.
Maltese: Il-vaċċin fih parvovirus ħaj attenwat tal-papra Muscovy.
English: Goose Parvovirus
Maltese: PARIR SABIEX
English: Duck Parvovirus
Maltese: Parvovajrus talpapra
English: Cardboard box of 1 bag of 2,500 doses.
Maltese: Kaxxa tal-kartun li fiha kunjett ta' 2,500 doża.
English: Transfer the content of the glass vial into the bag of diluent.
Maltese: Ittrasferixxi lkontenut tal-kunjett fil-borża tad-dilwent.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk concentrate for suspension for injection for Muscovy ducks
Maltese: VETERINARJU Parvoduk konċentrat għal injezzjoni għal papri Muscovy.
English: EXP Once diluted, use within 4 hours.
Maltese: EXP Ladarba dilwit , uża fi żmien 4 sigħat.
English: Shake the vial of antigen concentrate.
Maltese: Ħawwad il-kunjett bil-konċentrat tal-antiġen.
English: The demonstrated duration of immunity protects the birds during the period when they are most susceptible to Muscovy duck parvovirosis and Derzsy's disease.
Maltese: Il-tul ta' immunità muri jipproteġi t-tjur waqt il-perijodu meta jkunu l-iżjed suxxettibbli għallparvovirus tal-papri Muscovy u l-Marda ta' Derzsy.
English: Overdose (symptoms, emergency procedures, antidotes): No adverse reactions were observed after the administration of an overdose (10x the dose).
Maltese: L-ebda effetti mhux mixtieqa ma ġew osservati meta ingħatat doża eċċessiva ( 10 x id-doża)
English: --1 Lyophilisate (live attenuated) Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15
Maltese: --1 Lijofilizzat (attenwat ħaj) Canine parainfluenza type 2 virus, strejn CPiV-2-Bio 15
English: Lyophlilisate: vial (glass)
Maltese: Numru tal-UE Isem kummerċjali
English: Packaging
Maltese: TCID50*
English: Lyophilisate: vial (glass)
Maltese: Speċi li fuqhom għandu jintuża l-prodott
English: 75011 Paris France
Maltese: 75011 Pariġi
English: Lucane Pharma 172 rue de Charonne 75011 Paris France
Maltese: Manifattur Lucane Pharma 172 rue de Charonne 75011 Paris
English: Uncommon bradycardia
Maltese: Mhux komuni bradikardija
English: Eurocept International BV Tel: +31 35 528 39 57 info@eurocept.nl
Maltese: Eurocept International BV Tel: +31 35 528 39 57
English: Lucane Pharma 172 rue de Charonne
Maltese: 172 rue de Charonne
English: - The active substance is carglumic acid.
Maltese: - Is-sustanza attiva hi carglumic acid.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100) 100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma mfissra bħala: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10) u mhux komuni (≥1/1,000 sa <1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: • increased transaminases (liver enzymes),
Maltese: • żieda fit-transaminases (enzimi tal-fwied),
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Lucane Pharma
English: sodium stearyl fumarate, mannitol, copovidone K28, crospovidone type B.
Maltese: mannitol, copovidone K28, crospovidone tip B.
English: • bradycardia (decreased frequency of the heart),
Maltese: • bradikardija (tnaqqis fil-frekwenza tat-taħbit tal-qalb),
English: Lucane Pharma Teл.
Maltese: Lucane Pharma
English: Pack size of 12 or 60 tablets.
Maltese: Daqs tal-pakkett ta' 12 jew 60 pillola.
English: Ucedane 200 mg dispersible tablets carglumic acid
Maltese: Ucedane 200 mg pilloli li jinfirxu carglumic acid
English: Carglumic acid showed no significant mutagenic activity in a battery of genotoxicity tests performed in vitro (Ames test, human lymphocyte metaphase analysis) and in vivo (micronucleus test in rat).
Maltese: Carglumic acid ma wera l-ebda attività mutaġenika sinifikanti f'sensiela ta' testijiet dwar ilgenotossiċità mwettqa in vitro (Ames Test, analiżi tal-metafażi tal-limfoċiti fil-bniedem) u in vivo (eżami mikronuklejari fil-far).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients microcrystalline cellulose, mannitol, colloidal anhydrous silica, sodium stearyl fumarate, crospovidone type B, copovidone K 28.
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti microcrystalline cellulose, mannitol, colloidal anhydrous silica, sodium stearyl fumarate,
English: Luxembourg/Luxemburg
Maltese: Luxembourg/Luxemburg Lucane Pharma
English: Uncommon increased transaminases
Maltese: Mhux komuni transaminases ogħla
English: - The other ingredients are microcrystalline cellulose, colloidal anhydrous silica,
Maltese: - Sustanzi oħra jinkludu microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate,
English: info@lucanepharma.com info@lucanepharma.com
Maltese: info@medicalneed.com
English: Uncommon diarrhea, vomiting
Maltese: Mhux komuni dijarea, remettar
English: FrostPharma AB Tel: +46 775 86 80 02 info@frostpharma.com
Maltese: FrostPharma AB Tel: +46 775 86 80 02