FrancophonIA/ELRC3.0 huggingface dataset:
English: • The mixture will be whitish and cloudy.
Maltese: • It-taħlita se tkun bajdanija u mdardra.
English: Plasma and cerebrospinal fluid concentrations are linearly related to dose over the recommended dose range.
Maltese: Il-konċentrazzjonijiet fil-plażma u fil-fluwidu ċerebrospinali huma relatati b'mod lineari mad-doża fuq il-firxa tad-doża rakkomandata.
English: General disorders and fatigue oedema, irritability administratio n site conditions
Maltese: Disturbi ġenerali u kondizzjoniji għeja edema, irritabilità et ta' mnejn jingħata
English: 1 x 500 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening
Maltese: 1 x 500 mg u 1 x 100 mg pillola filgħodu
English: One tablet (500 mg) and one tablet (100 mg)
Maltese: Nofs pillola (500 mg) jew żewġ pilloli u nofs (100 mg)
English: Rare side effects (may affect up to 1 in 1,000 people) serious allergic reaction, which causes swelling of the face or throat.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 f'1,000) reazzjoni allerġika serja, li tikkawża nefħa fil-wiċċ jew fil-gerżuma.
English: Half a tablet (500 mg) or two and a half tablets (100 mg)
Maltese: Pillola waħda (500 mg) u pillola waħda (100 mg)
English: Luxe mbourg/Luxemburg ORPHELIA Pharma SAS Tél/Tel: + 33 1 42 77 08 18
Maltese: ORPHELIA Pharma SAS Tél/Tel: + 33 1 42 77 08 18
English: Fill a drinking glass with one or two teaspoons of water (approximately 5 or 10 ml), according to the age of the child. Add the prescribed number of Kigabeq tablets or tablet halves to the water.
Maltese: Imla tazza b'kuċċarina jew tnejn ilma (madwar 5 jew 10 ml), skont l-età tat-tifel/tifla.
English: Contact the doctor if your child has these psychological effects nausea (feeling sick), vomiting and abdominal pain blurred vision, double vision and uncontrolled movement of the eye, which may cause dizziness speech disorder decrease in the number of red blood cells (anaemia)
Maltese: Ikkuntattja lit-tabib jekk it-tifel/tifla tiegħek ikollu/ikollha dawn l-effetti psikoloġiċi dardir (taqlib), rimettar u uġigħ addominali vista mċajpra, vista doppja u ċaqliq mingħajr kontroll tal-għajnejn, li jista' jikkawża sturdament disturb fid-diskors tnaqqis fin-numru ta' ċelloli ħomor tad-demm (anemija)
English: 1 x 500 mg and 3 x 100 mg tablet morning 1 x 500 mg and 3 x 100 mg tablet evening
Maltese: 3 x 100 mg pillola filgħodu 3 x 100 mg pillola filgħaxija
English: 1 x 500 mg and 2 x 100 mg tablet morning 1 x 500 mg and 2 x 100 mg tablet evening
Maltese: 2 x 100 mg pillola filgħodu 2 x 100 mg pillola filgħaxija
English: Asymptomatic and transient Magnetic Resonance Imaging (MRI) abnormalities in the brain have been observed in some infants treated with vigabatrin for infantile spasms.
Maltese: Ġew osservati anormalitajiet mingħajr sintomi u temporanji fl-Immaġnijiet b'Riżonanza Manjetika (MRI) tal-moħħ f'xi trabi ttrattati b'vigabatrin għall-ispażmi infantili.
English: These reactions occurred in patients with and without a psychiatric history and were usually reversible when vigabatrin doses were reduced or gradually discontinued (see section 4.4).
Maltese: Dawn ir-reazzjonijiet seħħew f'pazjenti b'passat psikjatriku jew mingħajr u normalment kienu riversibbli meta d-dożi ta' vigabatrin tnaqqsu jew twaqqfu gradwalment (ara s-sezzjoni 4.4).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1302/001
Maltese: EU/1/18/1302/001
English: NAME OF THE MEDICINAL PRODUCT Kigabeq 500 mg soluble tablets vigabatrin
Maltese: Kigabeq 500 mg pilloli li jinħallu vigabatrin
English: It is used to treat infantile spasms (West's syndrome) or, together with other epilepsy medicines to treat partial epilepsy that is not controlled well enough with current treatment.
Maltese: Jintuża għat-trattament tal-ispażmi infantili (sindrome ta' West) jew, flimkien ma' mediċini oħrajn kontra l-epilessija għall- ta' epilessija parzjali li ma tkunx ikkontrollata biżżejjed bit-trattament attwali.
English: Vigabatrin is widely distributed with an apparent volume of distribution slightly greater than total body water.
Maltese: Vigabatrin jiġi distribwit b'mod wiesa' b'volum apparenti ta' distribuzzjoni kemxejn akbar mil-ilma totali tal-ġisem.
English: 1 x 500 mg and 1 x 100 mg tablet morning 1 x 500 mg and 2 x 100 mg tablet evening
Maltese: 1 x 500 mg u 1 x 100 mg pillola filgħaxija
English: Movement disorders can occur in young infants treated for infantile spasms (West's syndrome).
Maltese: Id-disturbi tal-moviment jistgħu jseħħu fi tfal żgħar ikkurati għall-ispażmi infantili (sindrome ta'
English: NAME OF THE MEDICINAL PRODUCT Kigabeq 100 mg soluble tablets vigabatrin
Maltese: - Pillola waħda li tinħall ta' Kigabeq 100 mg fiha 100 mg vigabatrin
English: Vigabatrin should not be used concomitantly with other retinotoxic medicinal products.
Maltese: Vigabatrin m'għandux jintuża fl-istess ħin ma' prodotti mediċinali retinotossiċi oħrajn.
English: Half a tablet (500 mg)
Maltese: Pillola u nofs (500 mg)
English: Lie tuva
Maltese: Tfal
English: A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Maltese: Metaanaliżi ta' provi aleatorji kkontrollati bi plaċebo ta' prodotti mediċinali antiepilettiċi ukoll uriet żieda żgħira fir-riskju ta' ħsibijiet u mġiba suwiċidali.
English: What Kigabeq looks like and contents of the pack Kigabeq are white oval scored soluble tablets.
Maltese: Kigabeq huma pilloli li jinħallu, ovali u bojod b'linja fin-nofs.
English: Vigabatrin should be gradually withdrawn under close medical supervision.
Maltese: Vigabatrin għandu jiġi rtirat b'mod gradwali taħt superviżjoni medika attenta.
English: Management
Maltese: Manifattur
English: Eye disorders visual field defect vision blurred, diplopia, nystagmus retinal disorder (such as peripheral retinal atrophy)
Maltese: diplopja, nistagmus disturb fir-retina
English: The full EPAR for Dificlir 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 is available as tablets (200 mg).
Maltese: Jiġi f'pilloli (200 mg).
English: EPAR summary for the public fidaxomicin
Maltese: Sommarju tal-EPAR għall-pubbliku fidaxomiċina
English: Dificlir has been compared with vancomycin (another antibiotic for C. difficile infections) in two main studies involving a total of 1,147 adult patients with mild to moderately severe C. difficile infection.
Maltese: Dificlir tqabbel mal-vankomiċina (antibijotiku ieħor kontra l-infezzjonijiet mis-C. difficile) f'żewġ studji ewlenin li b'kollox fihom ħadu sehem 1,147 pazjent adult b'infezzjoni mis-C. difficile minn moderata sa gravi.
English: Dificlir is a medicine that contains the active substance fidaxomicin.
Maltese: Dificlir huwa mediċina li fih is-sustanza attiva fidaxomiċina.
English: The active substance in Dificlir, fidaxomicin, is an antibiotic that belongs to the class of macrocylic antibiotics.
Maltese: Is-sustanza attiva f'Dificlir, il-fidaxomiċina, hija antibijotiku li tappartieni lill-klassi l-ġdida tal-antibijotiċi makroċikliċi.
English: How has Dificlir been studied?
Maltese: Kif ġie studjat Dificlir?
English: This is a summary of the European public assessment report (EPAR) for Dificlir.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Dificlir.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dificlir on 5 December 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Dificlir fil-5 ta' Diċembru 2011.
English: When looking at the results of the two studies, 92 % of patients on Dificlir were cured compared with 90% of patients on vancomycin.
Maltese: Ir-riżultati taż-żewġ studji juru li 92% tal-pazjenti li ngħataw Dificlir fiequ, apparagun mad-90% tal-pazjenti li ngħataw ilvankomiċina.
English: The effects of Dificlir were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Dificlir qabelxejn ġew ittestjati f'mudelli sperimentali qabel ma mbagħad ġew studjati fuq ilbnedmin.
English: What is the risk associated with Dificlir?
Maltese: X'inhu r-riskju assoċjat ma' Dificlir?
English: The CHMP considered that Dificlir was effective in curing C. difficile infections and was generally well tolerated with side effects that are similar to vancomycin.
Maltese: Is-CHMP qies li Dificlir kien effikaċi fil-kura tal-infezzjonijiet C. difficile u li ġeneralment il-pazjenti ttollerawh tajjeb b'xi effetti sekondarji li kienu simili għal dawk tal-vankomiċina.
English: At this point, a person is said to be infected with C. difficile.
Maltese: Dificlir kien effikaċi tal-inqas daqs il-vankomiċina kontra l-infezzjoni C. difficile.
English: Other information about Dificlir
Maltese: Kif jintuża Dificlir?
English: How is Dificlir used?
Maltese: X'inhu Dificlir?
English: Why has Dificlir been approved?
Maltese: Għaliex ġie approvat Dificlir?
English: Dificlir is used to treat adults with infections of the gut caused by bacteria called Clostridium difficile.
Maltese: Dificlir jintuża fit-trattament ta' adulti b'infezzjonijiet fl-imsaren ikkawżati mill-batterju Clostridium difficil.
English: The most common side effects with Dificlir (seen in between 1 and 10 patients in 100) are nausea (feeling sick), vomiting and constipation.
Maltese: L-effett sekondarju l-aktar komuni bl-użu ta' Dificlir (li deher f'bejn pazjent 1 u 10 minn 100) huma nawżja (dardir), remettar u stitikezza.
English: However, some antibiotics that are used to treat infections can interfere with the balance of 'good' bacteria in the gut.
Maltese: Madankollu ċerti antibijotiċi li jintużaw kontra l-infezzjonijiet jistgħu jikkawżaw interferenza fil-bilanċ tal-batterji ‘beninnji' fl-imsaren.
English: The CHMP noted however, that there are uncertainties about the effects of Dificlir in certain groups of patients such as those with liver and kidney problems and recommended that further studies in this group should be carried out.
Maltese: Madankollu s-CHMP irrimarka li għad fadal xi interċezzi dwar l-effetti ta' Dificlir f'ċerti gruppi ta' pazjenti bħal dawk li jkollhom problemi fil-fwied u fil-kliewi, u rrakkomanda li jsiru iżjed studji fuq dan il-grupp.
English: C. difficile are bacteria that are present naturally in the gut and do not cause any problems in healthy people.
Maltese: C. difficile huma batterji li jgħammru fl-imsaren b'mod naturali u li ma jikkawżaw l-ebda problema fissaħħa ta' persuni f'saħħithom.
English: polymerase, which is used to produce the RNA that the bacteria need to make proteins.
Maltese: Taħdem billi timblokka l-enzima batterika RNA polimerasi, li tintuża fil-produzzjoni tal-RNA meħtieġa mill-batterji biex jipproduċu l-proteini.
English: The recommended dose is one tablet twice a day (every 12 hours) for 10 days.
Maltese: Id-doża rakkomandata hija pillola waħda darbtejn kuljum (kull 12-il siegħa) għal 10 ijiem.
English: The CHMP considered the severity of C. difficile infections and the drawbacks of current treatments and concluded that benefits of Dificlir are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bl-użu ta' Dificlir, ara l-fuljett ta' tagħrif.
English: When this happens, C. difficile bacteria can multiply and produce toxins (poisons), which cause illness such as diarrhoea and fever.
Maltese: Meta jiġri hekk, il-batterji C. difficile jistgħu jitkattru u jipproduċu ċerti tossini (veleni) li jikkaġunaw mard bħad-dijarrea u d-deni.
English: It works by blocking the bacterial enzyme RNA
Maltese: Il-mediċina tinkiseb biss b'riċetta ta' tabib.
English: Article 34 of Directive 2001/82/EC
Maltese: L-Artikolu 34 tad-Direttiva 2001/82/KE
English: International non-proprietary name (inn): benazepril hydrochloride
Maltese: Denominazzjoni komuni internazzjonali (inn): benazepril hydrochloride
English: Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Maltese: Hydrochloride benazepril huwa promediċina idrolizzata in vivo għall-metabolit attiv tagħha, benazeprilat.
English: Opinion following an Article 34 referral for Fortekor and associated names EMA/965903/2011
Maltese: Opinjoni wara riferiment skont l-Artikolu 34 għal Fortekor u ismijiet assoċjati EMA/965903/2011
English: 6 February 2012
Maltese: 6 ta' Frar 2012
English: Opinion following an Article 34
Maltese: Opinjoni wara riferiment skont l-Artikolu 34
English: In line with the principles of referrals under Article 34(1) of Directive 2001/82/EC, on 16 September 2010 Sweden sent a revised referral notification under Article 34(1) of Directive 2001/82/EC and extended the scope of the referral procedure to all Fortekor and associated names tablet strengths and formulations.
Maltese: F'konformità mal-prinċipji ta' referenzi tal-Artikolu 34(1) tad-Direttiva 2001/82/KE, fis16 ta' Settembru 2010, l-Isvezja bagħtet notifika ta' riferiment riveduta skont l-Artikolu 34(1) tadDirettiva 2001/82/KE u estendiet il-kamp ta' applikazzjoni tal-proċedura ta' riferiment għal kull kontenut u formulazzjonijiet tal-pilloli ta' Fortekor u ismijiet assoċjati.
English: The Committee appointed Dr Karolina Törneke as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur.
Maltese: Törneke bħala rapporteur u lil Dr Michael Holzhauser-Alberti bħala korapporteur.
English: Fortekor and associated names is a veterinary medicinal product containing benazepril hydrochloride presented in 2.5 mg, 5 mg and 20 mg flavoured tablets and 5 mg and 20 mg film-coated tablets intended for use in dogs and cats.
Maltese: Fortekor u ismijiet assoċjati huwa prodott mediċinali veterinarju li fih hydrochloride benazepril ippreżentat f'pilloli bit-togħma ta' 2.5 mg, 5 mg u 20 mg u f'pilloli miksija b'rita ta' 5 mg u 20 mg li huma maħsuba biex jintużaw għall-klieb u għall-qtates.
English: The referral procedure started on 11 November 2009.
Maltese: Il-proċedura ta' riferiment bdiet fil-11 ta' Novembru 2009.
English: referral for
Maltese: III.
English: Veterinary Medicines and Product Data Management
Maltese: Mediċini Veterinarji u Ġestjoni ta' Dejta dwar il-Prodotti
English: Due to the divergent decisions taken by Member States concerning the authorisation of Fortekor and associated names (5 mg benazepril hydrochloride film-coated tablet) and differences between the summary of product characteristics of the product as authorised in the Member States, the issue was referred on 16 October 2009 by Sweden to the CVMP under Article 34(1) of Directive 2001/82/EC.
Maltese: Minħabba d-deċiżjonijiet diverġenti meħuda mill-Istati Membri dwar l-awtorizzazzjoni ta' Fortekor u ismijiet assoċjati (pillola miksija b'rita ta' hydrochloride benazepril ta' 5 mg) u d-differenzi bejn issommarju tal-karatteristiċi tal-prodott kif awtorizzat fl-Istati Membri, il-kwistjoni ġiet riferuta fis16 ta' Ottubru 2009 mill-Isvezja lis-CVMP skont l-Artikolu 34(1) tad-Direttiva 2001/82/KE.
English: Oral explanations were given on 4 May 2011.
Maltese: L-ispjegazzjonijiet bil-fomm ingħataw fl4 ta' Mejju 2011.
English: holders' oral explanations to the Committee, the CVMP, at its May 2011 meeting, agreed that an ad-hoc expert group should be consulted regarding the scientific evidence base for angiotensin converting enzyme inhibitor in the treatment of chronic kidney disease in dogs.
Maltese: Wara l-ispjegazzjonijiet bil-fomm mid-detenturi tal-awtorizzazzjoni għallkummerċjalizzazjzoni lill-Kumitat, is-CVMP, fil-laqgħa tiegħu ta' Mejju 2011, qabel li għandu jiġi kkonsultat grupp ta' esperti ad-hoc dwar il-bażi ta' evidenza xjentifika għall-inibitur ta' enżima li tikkonverti l-anġotensina fit-trattament ta' mard kroniku tal-kliewi fl-klieb.
English: The Committee adopted a positive opinion by majority on 10 November 2011.
Maltese: IlKumitat adotta opinjoni pożittiva b'maġġoranza fl-10 ta' Novembru 2011.
English: An ad-hoc expert group meeting was held on 10 October 2011 and the marketing authorisation holders attended the meeting for an oral explanation.
Maltese: Fl-10 ta' Ottubru 2011 saret laqgħa tal-grupp ta' esperti ad-hoc u d-detenturi tal-awtorizzazzjoni għall-kummerċjalizzazzjoni attendew il-laqgħa għal spjegazzjoni bil-fomm.
English: Written explanations were provided by the marketing authorisation holders on 24 May 2010 and 6 January 2011.
Maltese: Fl-24 ta' Mejju 2010 u fis-6 ta' Jannar 2011, id-detenturi tal-awtorizzazzjoni għallkummerċjalizzazzjoni pprovdew spjegazzjonijiet bil-miktub.
English: Based on the assessment of the currently available data and further to a consultation with the ad-hoc expert group, the CVMP considered that the benefit-risk balance for Fortekor and associated names remains positive, except for the chronic kidney disease in dogs, subject to variation of the marketing authorisations in accordance with the recommended product information.
Maltese: Abbażi tal-valutazzjoni tad-dejta attwalment disponibbli u wara konsultazzjoni mal-grupp ta' esperti ad hoc, is-CVMP ikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju għal Fortekor u ismijiet assoċjati jibqa' wieħed pożittiv, ħlief għall-mard tal-kliewi kroniku fil-klieb, soġġett għall-varjazzjoni talawtorizzazzjonijiet għall-kummerċjalizzazzjoni skont l-informazzjoni tal-prodott irrakkomandata.
English: Benazeprilat is a highly potent and selective inhibitor of angiotensin converting enzyme, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone.
Maltese: Benazeprilat huwa inibitur qawwi ħafna u selettiv ta' enzima li tikkonverti l-anġotensina, u li b'hekk timpedixxi l-konverżjoni ta' anġotensina inattiva I għal anġotensina attiva
English: The final opinion was converted into a Decision by the European Commission on 6 February 2012.
Maltese: L-opinjoni finali ġiet ikkonvertita f'Deċiżjoni mill-Kummissjoni Ewropea fi 6 ta' Frar 2012.
English: Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom
Maltese: Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ Renju Unit
English: The Reference Member State was Ireland and the Concerned Member States were Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Greece, Spain, Finland, France, Hungary, Iceland, Latvia, Lithuania, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden.
Maltese: L-Istati Membru ta' Referenza kienet l-Irlanda u lIstati Membri Kkonċernati kienu l-Awstrija, il-Bulgarjia, Ċipru, ir-Repubblika Ċeka, id-Danimarka, lEstonja, il-Greċja, Spanja, il-Finlandja, Franza, l-Ungerija, l-Islanda, il-Latvja, il-Litwanja, Malta, ilPajjiżi l-Baxxi, in-Norveġja, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja u l-Isvezja.
English: The product has claims for persistent efficacy ranging from 18 to 42 days.
Maltese: Ġie ddikkjarat li l-prodott għandu effikaċja persistenti li tvarja bejn 18 sa 42 jum.
English: Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Maltese: Iż-żewġ komposti jikkondividu spettru wiesa' ta' attività antiparasitika u jipproduċu paraliżi simili f'nematodi u artropodi parasitiċi.
English: The n-octanol/water coefficient (log Pow) was determined as 4.4 using the shake flask method.
Maltese: Ġie stabbilit li l-koeffiċjent n-octanol/ilma (log Pow) huwa ta' 4.4 bil-metodu ‘shake flask'.
English: The weights of animals were below 250 kg. Only injection sites (500-600 g) were sampled.
Maltese: Ġew kampjunati s-siti ta' injezzjoni (500-600 g) biss.
English: Whereas:
Maltese: BAQAR:
English: The log Pow of 4.4 can therefore only be considered as an indicator of the actual value.
Maltese: Għaldaqstant, il-log Pow ta' 4.4 jista' jitqies biss bħala indikatur tal-valur attwali.
English: • During this referral procedure in Ireland the marketing authorisations of the two reference products Dectomax 1% w/v solution for injection for cattle and sheep and Dectomax 10 mg/ml solution for injection for pigs were transferred from Pfizer Healthcare Ireland to Elanco Animal Health, Eli Lilly and Company Limited and the names of the reference products in Ireland were changed to Zearl 10 mg/ml solution for injection for cattle and sheep and Zearl 10 mg/ml solution for injection for pigs).
Maltese: • Matul din il-proċedura ta' konsultazzjoni, fl-Irlanda, l-awtorizzazzjoni għat-tqegħid fis-suq tażżewġ prodotti ta' referenza, Dectomax 1% w/v soluzzjoni għal injezzjoni għal frat u nagħaġ u Dectomax 10 mg/ml soluzzjoni għal injezzjoni għal ħnieżer ġew trasferiti minn Pfizer Healthcare Ireland għal Elanco Animal Health, Eli Lilly and Company Limited u l-ismijiet talprodotti ta' referenza fl-Irlanda nbidlu għal Zearl 10 mg/ml soluzzjoni għal injezzjoni għal frat u nagħaġ u Zearl 10 mg/ml soluzzjoni għal injezzjoni għal ħnieżer).
English: The application has been presented in accordance with Article 13(1) of Directive 2001/82/EC as amended, i.e. it is a generic application.
Maltese: Lapplikazzjoni ġiet ippreżentata skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE kif emendata, jiġifieri hija applikazzjoni ġenerika.
English: Cattlesubcutaneous
Maltese: Valutazzjoni tal-benefiċċji
English: An ERA was performed by the applicant in accordance with the VICH guidelines for Phase I and Phase II assessment adopted by the CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final) as well as the CVMP guideline on Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH Guidelines GL6 and GL38 (CVMP/ERA/418282/2005-corr).
Maltese: Twettqet ERA mill-applikant skont il-linji gwida tal-VICH għall-valutazzjoni tal-Fażi I u l-Fażi II adottati mis-CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final) kif ukoll il-linja gwida tas-CVMP dwar il-Valutazzjoni tal-Impatt Ambjentali għall-Prodotti Mediċinali Veterinarji b'appoġġ tal-Linji Gwida talVICH GL6 u GL38 (CVMP/ERA/418282/2005-corr).
English: The application was submitted in accordance with the Article 13(1) of the Directive 2001/82/EC (i.e. an application for a generic product).
Maltese: Lapplikazzjoni ġiet sottomessa skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE (jiġifieri applikazzoni għal prodott ġeneriku).
English: 4.11 Withdrawal Period(s)
Maltese: 4.11 Perjodu(i) ta' Tiżmim
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, withdrawal periods, applicant in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, saħħa tal-prodott mediċinali veterinarju, speċi ta' annimal, metodu ta' amministrazzjoni, perjodi ta' tiżmim, applicant fl-iStati Membri
English: Doramectin is an antiparasitic agent, isolated from the fermentation of selected strains derived from the soil organism Streptomyces avermitilis.
Maltese: Id-doramektina hija aġent antiparasitiku, iżolata mill-fermentazzjoni ta' razez magħżula derivati mill-organiżmu tal-ħamrija Streptomyces avermitilis.
English: Muscle: 40 μg/kg
Maltese: Muskolu: 40 μg/kg
English: The following MRLs have been established in the EU for the active substance doramectin (Table 1 of the Annex to Regulation (EU) No 37/2010 for all mammalian food producing species:
Maltese: L-MRLs li ġejjin ġew stabbiliti fl-UE għas-sustanza attiva doramektina (it-Tabella 1 tal-Anness għarRegolament (UE) Nru 37/2010 għall-ispeċi mammali kollha li jipproduċu l-ikel:
English: Pigs - 1 ml per 33 kg bodyweight
Maltese: Ħniezer - 1 ml kull 33 kg piż
English: CATTLE: Meat and offal:withdrawal period: 54 days.
Maltese: Laħam u ġewwieni:perjodu ta' tiżmim: 54 jum.