FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, concerns were raised over the adequacy of the data provided by the Marketing Authorisation Holder on the incidence of bovine respiratory disease (BRD) within an infected herd and as a consequence objections were raised over the proposal to deviate from the default value of 50% specified in CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) as the value for the proportion of infected animals for use in calculation of the Predicted Environmental Concentration in soil (PECsoil).
Maltese: B'mod partikolari, tqajjem tħassib dwar l-adegwatezza tad-data pprovduta mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq dwar l-inċidenza ta' mard respiratorju bovin (bovine respiratory disease - BRD) f'merħla infettata u b'konsegwenza tqajmu oġġezzjonijiet dwar il-proposta ta' devjazzjoni mill-valur prestabbilit ta' 50% speċifikat fil-Gwida dwar il-Valutazzjoni tal-Impatt Ambjentali għal Prodotti Mediċinali Veterinarji tas-CVMP b'Appoġġ għal-Linji gwida VICH GL6 u GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) bħala l-valur għall-proporzjon ta' annimali infettati għall użu fil-kalkolu tal-Konċentrazzjoni Ambjentali
English: = Number of days of treatment [d] BW = Animal body weight [kgbw] (see Table 3 of the guideline.)
Maltese: = Piż tal-ġisem tal-annimal [kgbw] (ara t-Tabella 3 tal-linja gwida.)
English: The product is presented as a solution for injection containing 300 mg of florfenicol per ml solution for injection and it is intended for the therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Maltese: Il-prodott huwa disponibbli bħala soluzzjoni għall-injezzjoni li fiha 300 mg ta' florfenicol għal kull ml ta' soluzzjoni għall-injezzjoni u huwa maħsub għall-kura terapewtika ta' infezzjonijiet tal-apparat respiratorju fil-frat ikkawżati minn Mannheimia haemolytica, Pasteurella multocida u Histophilus somni.
English: Invented name Pharmaceutical form
Maltese: TAL-PRODOTT MEDIĊINALI
English: The Marketing Authorisation Holder provided data with the aim of demonstrating that the percentage of herd animals that will be treated for Bovine Respiratory Disease (BRD) is less than the default value of 50% given in the CVMP guideline mentioned above (EMEA/CVMP/ERA/418282/2005Rev.1).
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda dejta bl-għan li juri li l-perċentwal ta' annimali tal-merħla li sejrin jiġu kkurati għall-Mard Respiratorju Bovin (BRD) huwa inqas mill-valur prestabbilit ta' 50% mogħti fil-linja gwida tas-CVMP msemmi hawn fuq (EMEA/CVMP/ERA/418282/2005-Rev.1).
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER/APPLICANT IN THE MEMBER STATES
Maltese: VETERINARJU, SPEĊI TA' ANNIMALI, MNEJN JINGĦATA, DETENTUR/APPLIKANT TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI
English: The DT50 was further recalculated in accordance with a biphasic model.
Maltese: Id-DT50 ġie kkalkulat mill-ġdid f'konformità ma' mudell bifażiku.
English: = Housing factor either 1 for animals housed throughout the year or 0.5 for animals housed for only 6 months (see Table 3 of the guideline) = Conversion factor [1000 μg.mg-1]
Maltese: = (Housing factor) Fattur ta' akkomodazzjoni: 1 għal annimali miżmuma ġewwa matul is-sena kollha jew 0.5 għal annimali miżmuma ġewwa għal 6 xhur biss (ara t-Tabella 3 tal-linja gwida) = Fattur ta' konverżjoni [1000 μg.mg-1]
English: According to the CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guideline GL6 and GL38 (EMEA/CVMP/ERA/418282/2005Rev.1), complete degradation has to be demonstrated either by total mineralisation or by the presence of degradation products all representing 5% or less of the total dose.
Maltese: Skont il-Linja Gwida tas-CVMP dwar il-Valutazzjoni tal-Impatt Ambjentali għal Prodotti Mediċinali Veterinarji b'Appoġġ għal-Linji gwida VICH GL6 u GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1), id-degradazzjoni sħiħa għandha tintwera jew permezz tal-mineralizzazzjoni totali jew bil-preżenza ta' prodotti ta' degradazzjoni li kollha jirrappreżentaw 5% jew inqas tad-doża totali.
English: • The nature and the biological activity of bound residues is not known,
Maltese: • In-natura u l-attività bijoloġika ta' residwi marbuta mhumiex magħrufa,
English: Bristol
Maltese: Il-Belġju
English: The CVMP considers that the therapeutic indication as currently authorised in the Reference Member State does not make the limitations of the approved use clear as the existing wording could be interpreted as allowing use of the product for preventative and therapeutic treatment of all diseases caused by florfenicol susceptible bacteria.
Maltese: Is-CVMP jikkunsidra li l-indikazzjoni terapewtika kif awtorizzata fil-preżent flIstat Membru ta' referenza ma tiċċarax il-limiti tal-użu approvat minħabba li l-formulazzjoni attwali tista' tiġi interpretata bħala li l-użu tal-prodott għal kura preventiva u terapewtika tal-mard kollu kkawżat minn batterji suxxettibbli għal florfenicol huwa permess.
English: • Commercial farms (several breeds and age): France - 15.7%, Germany - 20.3%, Italy - 15.2%, Spain - 17.1% (Godinho et al, 20055).
Maltese: 2%, Spanja - 17.1% (Godinho et al, 20055).
English: The PECsoil for each cattle type (calves, dairy cows, cattle 0-1 year, cattle over 2 years) has been calculated using 38% as the proportion of the herd treated, according to the following formula (from the CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1).
Maltese: Il-PECħamrija għal kull tip ta' frat (għoġiela, baqar tal-ħalib, frat minn 0 sa sena, frat 'il fuq minn sentejn) ġie kkalkulat bl-użu ta' 38% bħala l-proporzjon tal-merħla kkurata, skont il-formola li ġejja (mil-Linja Gwida tas-CVMP dwar il-Valutazzjoni tal-Impatt Ambjentali għal Prodotti Mediċinali Veterinarji b'Appoġġ għalLinji gwida VICH GL6 u GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1).
English: It is assumed that veterinary medicinal products with limited use and limited environmental exposure will have a limited impact on the environment.
Maltese: Huwa ipotizzat li prodotti mediċinali veterinarji b'użu limitat u espożizzjoni ambjentali limitata jkollhom impatt limitat fuq l-ambjent.
English: To support the argument that the environmental risk assessment could be completed at Phase I, the Marketing Authorisation Holder also provided a manure degradation study, which was performed in accordance with the criteria laid out in the above mentioned CVMP guideline.
Maltese: Bħala sostenn għall-argument li l-valutazzjoni tar-riskju ambjentali tista' titlesta f'Fażi I, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda wkoll studju ta' degradazzjoni tad-demel, li sar f'konformità mal-kriterji stabbiliti fil-linja gwida tas-CVMP msemmija hawn fuq.
English: When such specific information is not available then the default values given in Table 2 of the CVMP guideline in support of VICH guidelines (Guideline on Environmental Impact Aassessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - EMEA/CVMP/ERA/418282/2005Rev.1 - also known as the Technical Guidance Document - TGD) should be used.
Maltese: Gwida dwar il-Valutazzjoni tal-Impatt Ambjentali għal Prodotti Mediċinali Veterinarji b'Appoġġ għal-Linji gwida VICH GL6 u GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1 - magħrufin ukoll bħala d-Dokument ta' Gwida Teknika - TGD).
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI
English: The CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) indicates that the proportion of animals in the herd which is treated may be available from information in the dossier such as field trial data or from the scientific literature.
Maltese: Il-Linja Gwida tas-CVMP dwar il-Valutazzjoni tal-Impatt Ambjentali għal Prodotti Mediċinali Veterinarji b'Appoġġ għal-Linji Gwida VICH GL6 u GL38 (EMEA/CVMP/ERA/418282/2005Rev.1) tindika li l-proporzjon ta' annimali fil-merħla li tkun qiegħda tiġi ttrattata jista' jkun disponibbli minn informazzjoni fid-dossier, bħalma hija d-data ta' prova fil-post ta' applikazzjoni jew mill-materjal letterarju xjentifiku.
English: place-1.y-1] (see Table 3 of the guideline)
Maltese: = Nitroġenu prodott f'sena f'kull post [kg.N. post-1.s-1] (ara t-Tabella 3 tal-linja gwida)
English: 2.3 Degradation of residues in manure
Maltese: 2.3 Degradazzjoni tar-residwi fid-demel
English: The CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL8 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) provides default values for the proportion of animals in a herd which is treated, for use in the calculation of PECsoil.
Maltese: Il-Linja Gwida tas-CVMP dwar il-Valutazzjoni tal-Impatt Ambjentali għal Prodotti Mediċinali Veterinarji b'Appoġġ għal-Linji gwida VICH GL6 u GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) tipprovdi valuri stabbiliti minn qabel għall-proporzjon ta' annimali f'merħla li tkun qiegħda tiġi kkurata, għall-użu fil-kalkolu tal-PECħamrija.
English: Marixino memantine
Maltese: Marixino memantina
English: The full EPAR for Marixino 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: Marixino is a ‘generic medicine'.
Maltese: Marixino huwa ‘mediċina ġenerika'.
English: This is a summary of the European public assessment report (EPAR) for Marixino.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Marixino.
English: It contains the active substance memantine hydrochloride.
Maltese: Dan fih is-sustanza attiva memantina.
English: What are the benefits and risks of Marixino?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Marixino?
English: Marixino is available as 10 mg and 20 mg tablets and can only be obtained with a prescription.
Maltese: Marixino jiġi f'pilloli ta' 10 mg u 20 mg u jinkiseb biss b'riċetta ta' tabib.
English: The active substance in Marixino, memantine, is an antidementia medicine.
Maltese: Is-sustanza attiva f'Marixino, il-memantina, hija mediċina kontra d-dimenzja.
English: Why is Marixino approved?
Maltese: Għal xiex ġie approvat Marixino?
English: Marixino is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Maltese: Marixino huwa mediċina li tintuża fit-trattament ta' pazjenti bil-marda ta' Alzheimer moderata sa gravi, tip ta' dimenzja (diżordni fil-moħħ) li b'mod gradwali taffettwa l-memorja, il-kapaċità intellettwali u limġiba.
English: This means that Marixino is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Maltese: Dan ifisser li Marixino huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Ebixa.
English: For more information, see the package leaflet.
Maltese: Preċedentement magħrufa bħala Maruxa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Maruxa on 29 April 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Marixino valida fl-Unjoni Ewropea kollha fid-29 ta' April 2013.
English: ‘Bioequivalent' means that the medicines are expected to produce the same levels of the active substance in the body.
Maltese: ‘Bijoekwivalenti' tfisser li lmediċini jkunu mistennija jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: Because Marixino 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: Billi Marixino 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: By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
Maltese: Billi timblokka r-riċetturi NMDA, il-memantina ttejjeb it-trażmissjoni tas-sinjali fil-moħħ u tnaqqas is-sintomi tal-marda ta' Alzheimer.
English: To prevent side effects, the dose of Marixino is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Maltese: Bil-għan li jiġu evitati l-effetti sekondarji, id-doża ta' Marixino tiżdied bil-mod il-mod matul l-ewwel tliet ġimgħat tat-trattament: fl-ewwel ġimgħa d-doża tkun 5 mg; fit-tieni ġimgħa titla' għal 10 mg; u fit-tielet ġimgħa ssir 15 mg.
English: The name of the medicine was changed to Marixino on 9 August 2013.
Maltese: L-isem tal-mediċina nbidel f' Marixino fl-Fid-9 ta' Awwissu 2013.
English: What measures are being taken to ensure the safe and effective use of Marixino?
Maltese: X'miżuri qed jittieħdu biex jassiguraw l-użu sigur u effikaċi ta' Marixino?
English: How has Marixino been studied?
Maltese: Kif ġie studjat Marixino?
English: The Committee recommended that Marixino be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Marixino ikun approvat għall-użu fl-UE.
English: Therefore, the CHMP's view was that, as for Ebixa, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Ebixa, il-benefiċċji huma akbar mir-riskji identifikati.
English: It is not intended to provide practical advice on how to use Marixino.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika fuq l-użu ta' Marixino.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Marixino has been shown to have comparable quality and to be bioequivalent to Ebixa.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-Aġenzija kkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Marixino għandu kwalità kumparabbli u huwa bijoekwivalenti għal Ebixa.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Marixino, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzoni rigward issigurtà ta' Marixino, fosthom il-prekawzjonijiet xierqa li jridu jkunu segwiti mill-professjonisti fil-kura tas-saħħa u mill-pazjenti.
English: 15 September 2017 EMA/609151/2017 EMEA/H/C/004388
Maltese: 15 ta' Settembru 2017 EMA/609151/2017 EMEA/H/C/004388
English: The company that applied for authorisation is XBiotech Germany GmbH.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija XBiotech Germany GmbH.
English: What is Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech?
Maltese: IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech?
English: On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicine ‘Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech', intended for intended for treating debilitating symptoms of advanced colorectal cancer.
Maltese: Fit-18 ta' Mejju 2017, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-mediċina 'Human
English: Outcome of re-examination
Maltese: Human
English: This is a medicine containing the active substance human IgG1 monoclonal antibody specific for human interleukin-1 alpha.
Maltese: Dan huwa mediċina li fiha s-sustanza attiva human IgG1 monoclonal antibody specific for human interleukin-1 alpha.
English: The medicine was compared with placebo (a dummy treatment).
Maltese: Ilmediċina tqabblet ma' plaċebo (kura finta).
English: By blocking the actions of human interleukin-1 alpha, the medicine was expected to slow down the growth of the cancer, thus relieving patients' symptoms.
Maltese: Billi timblokka l-azzjonijiet ta' human interleukin-1 alpha, ilmediċina hija mistennija li tnaqqas it-tkabbir tal-kanċer, u b'hekk ittaffi s-sintomi tal-pazjenti.
English: The medicine was expected to be used for treating debilitating symptoms of advanced colorectal cancer (cancer of the large intestine).
Maltese: Il-mediċina kienet mistennija li tintuża għall-kura ta' sintomi debilitanti ta' kanċer kolorettali avvanzat (kanċer tal-musrana l-ħoxna).
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, is-CHMP għamel eżaminazzjoni mill-ġdid tal-opinjoni inizjali u kkonferma r-rifjut talawtorizzazzjoni għat-tqegħid fis-suq fl-14 ta' Settembru 2017.
English: Lastly, there were inadequate controls of the manufacturing process to ensure the medicine would have the same quality as the product used in clinical trials.
Maltese: Fl-aħħar nett, kien hemm kontrolli inadegwati tal-proċess ta' manifattura biex jiġi żgurat li l-mediċina jkollha l-istess kwalità bħall-prodott użat fil-provi kliniċi.
English: Secondly, at that time, there appeared to be an increased risk of infection in patients taking the medicine, which was not considered acceptable in vulnerable patients who will be receiving palliative care.
Maltese: It-tieni nett, deher li kien hemm riskju akbar ta' infezzjoni fil-pazjenti li jieħdu l-mediċina, li ma ġiex ikkunsidrat bħala aċċettabbli f'pazjenti vulnerabbli li ser jirċievu kura palljativa.
English: Such symptoms include cachexia, a form of muscle wasting with significant weight loss.
Maltese: Tali sintomi jinkludu kakessja, li hija forma ta' rquqija żejda tal-muskolu b'telf sinifikanti fil-piż.
English: The active substance is a protein that attaches to and blocks the actions of another protein called human interleukin-1 alpha, which is involved in many activities in the body including some that aid the
Maltese: Is-sustanza attiva hija proteina li tintrabat ma' u timblokka l-azzjonijiet ta' proteina oħra msejħa human interleukin-1 alpha, li hija involuta f'bosta attivitajiet fil-ġisem inkluż xi wħud li jgħinu fittkabbir u t-tixrid taċ-ċelloli tal-kanċer.
English: VIRBAC Danmark A/S Profilvej 1
Maltese: Danimarka VIRBAC Danmark A/S Profilvej 1
English: ATC vet code : QG04C X
Maltese: Kodiċi vet ATC : QG04C X
English: For a full list of excipients, see section 6.1.
Maltese: Għal lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: PHARMACEUTICAL FORM Tablet.
Maltese: FORMA FARMAĊEWTIKA Pillola.
English: Date of first authorisation: 11/01/2007 Date of latest renewal: 19/12/2011
Maltese: Data tal-ewwel awtorizazzjoni: 11/01/2007 Data tal-aħħar tiġdid: 19/12/2011
English: Ελλάδα
Maltese: U/JEW UŻU
English: PACKAGE SIZE 7 tablets.
Maltese: ID-DAQS TAL-PAKKETT 7 pilloli.
English: Nederland
Maltese: Olanda
English: PHARMACEUTICAL FORM
Maltese: FORMA FARMAĊEWTIKA
English: Tablet Round, white, biconvex tablet of 5.5 mm, 7 mm, 9 mm and 12 mm.
Maltese: Pillola Pillola tonda, bajda, bikonvessa ta' 5.5 mm, 7 mm, 9 mm u 12-il mm.
English: France VIRBAC 13ème rue - L.I.D - BP 27 F-06517 Carros
Maltese: Franza VIRBAC 13ème rue - L.I.D - BP 27 F-06517 Carros
English: United Kingdom VIRBAC Ltd UK-Suffolk IP30 9 UP Tel: 44 (0) 1359 243243
Maltese: VIRBAC Ltd UK-Suffolk IP30 9 UP Tel: 44 (0) 1359 243243
English: 4.11 Withdrawal period(s)
Maltese: 4.11 Perjodu(i) ta' rtirar
English: Polska
Maltese: Polonja
English: España
Maltese: Spanja
English: 4.6 Adverse reactions (frequency and seriousness)
Maltese: 4.6 Reazzjonijiet avversi (frekwenza u serjetà)
English: 4.1 Target species
Maltese: 4.1 Speċi targittati
English: 4.8 Interaction with other medicinal products and other forms of interaction
Maltese: .8 Interazzjoni ma' prodotti oħra mediċinali u modijiet oħra ta' interazzjoni
English: Carmellose calcium
Maltese: Kalċju karamellosju
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti, jekk meħtieġa
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 hi disponibbli fuq is-sit ta' l-internet ta' l-Aġenzija Ewropea tal-Mediċini http://www.ema.europa.eu/
English: Latvija
Maltese: Latvja
English: 5.2 Pharmacokinetic particulars
Maltese: .2 Dettalji farmakokinetiċi
English: Osaterone is a steroid anti-androgen, which inhibits the effects of an excess production of male hormone (testosterone).
Maltese: Osaterone hu sterojdi anti-androġina, li jimpedixxi l-effetti ta' produzzjoni eċċessiva ta' l-ormon maskil (testosteron).
English: Also, the major metabolite of osaterone acetate (15β-hydroxylatedosaterone acetate) has anti-androgenic activity.
Maltese: Barra minn hekk, il-metabolita ewlieni ta' l-osaterone acetate (15β-hydroxylated-osaterone acetate) għandha attività anti-androġenika.
English: Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate Excipients:
Maltese: Kull pillola tikkuntieni 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate
English: The clinical response persists for at least 5 months after treatment.
Maltese: Ir-reazzjoni klinika tippersisti għal mill-inqas 5 xhur wara t-trattament.
English: After a dose of 0.25 mg/kg/day, the mean maximum concentration (Cmax) in plasma is about 60 µg/l.
Maltese: Wara doża ta' 0.25 mg/kg/ġurnata, ilkonċentrazzjoni medja massima (Cmax) fil-plażma hi madwar 60 µg/l.
English: EXPIRY DATE EXP {month/year}
Maltese: EXP {xahar/sena}
English: Osaterone acetate and its metabolite are bound to plasma proteins (around 90% and 80% respectively), mainly to albumin.
Maltese: L-osaterone acetate u il-metabolita tiegħu huma magħqudin malproteini tal-plażma (madwar 90% u 80% rispettivament), il-biċċa l-kbira ma' l-albumina.
English: A single oral dose of 40 mg osaterone acetate in human males was followed by a sporadic decrease in FSH, LH and testosterone, reversible after 16 days.
Maltese: Doża orali waħda ta' 40 mg osaterone acetate fil-maskji umani ġiet segwita minn nuqqas sporadiku flFSH, LH u testosteron, riversibbli wara 16-il ġurnata.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Maltese: METODU U ROTOT TA' AMMINISTRAZZJONI Użu orali.
English: Luxembourg/Luxemburg VIRBAC BELGIUM S.A. B-3001 Leuven Tel: 32 (0) 10 47 06 35
Maltese: Lussemburgu VIRBAC BELGIUM S.A. B-3001 Leuven Tel: 32 (0) 10 47 06 35
English: In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions.
Maltese: Fl-annimali femminili tal-laboratorju, l-osaterone acetate jikkawża effetti avversi serji fuq ilfunzjonijiet riproduttivi.
English: Eesti
Maltese: Estonja
English: A single oral dose of 40 mg osaterone acetate in human males was followed by a sporadic decrease of sexual hormones, reversible after 16 days.
Maltese: Doża orali waħda ta' 40 mg osaterone acetate f'umani ta' sess maskili ġiet segwita minn nuqqas sporadiku fl-ormoni sesswali, riversibbli wara 16-il ġurnata.
English: YPOZANE tablets to be administered
Maltese: Il-piż tal-kelb Pilloli YPOZANE biex jiġu amministrati
English: ADVICE ON CORRECT ADMINISTRATION
Maltese: PARIR DWAR AMMINISTRAZZJONI KORRETTA
English: België/Belgique/Belgien VIRBAC BELGIUM S.A. B-3001 Leuven Tel: 32 (0) 10 47 06 35
Maltese: VIRBAC BELGIUM S.A. B-3001 Leuven Tel: 32 (0) 10 47 06 35