FrancophonIA/ELRC3.0 huggingface dataset:
English: Nemdatine 15 mg film-coated tablets:
Maltese: Nemdatine 15 mg pilloli miksija b'rita:
English: Nemdatine 5 mg film-coated tablets:
Maltese: Nemdatine 5 mg pilloli miksija b'rita:
English: IJsland/Islande/Island Tél/Tel: +354 5503300
Maltese: Islande/Island Tél/Tel:
English: Each film-coated tablet contains 0.95 mg lactose monohydrate.
Maltese: Nemdatine 10 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 0.95 mg lactose monohydrate.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/018
Maltese: FIS-SUQ EU/1/13/824/018
English: 5 mg tablet
Maltese: 3 pilloli ta' 5mg
English: Nemdatine 5 mg film-coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, with the marking “M5” engraved on one side.
Maltese: Il-pilloli Nemtadine miksijin b'rita ta' 5 mg huma bojod, f'għamla ovali ta' daqs ta' 8 mm x 4.5 mm, b'marka ta' ‘M5' fuq naħa waħda.
English: Blister packs: 42 and 98 film-coated tablets.
Maltese: Pakketti b'folji: 42 u 98 pilloli miksija b'rita.
English: Each film-coated tablet contains 1.89 mg lactose monohydrate.
Maltese: Nemdatine 20 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 1.89 mg lactose monohydrate.
English: White, oval shaped, biconvex film-coated tablets, 8 mm x 4.5 mm in size, with the marking “M5”
Maltese: Pilloli miksija b'rita, bojod, f'għamla ovali ta' daqs ta' 8 mm x 4.5 mm, b'marka ta' ‘M5' fuq naħa waħda.
English: White, oval shaped, biconvex film-coated tablet, 8 mm x 4.5 mm in size, with the marking “M5”
Maltese: Id-dehra ta' Nemdatine u l-kontenuti tal-pakkett Il-pilloli Nemdatine miksijin b'rita ta' 5 mg huma bojod, f'għamla ovali ta' daqs ta' 8 mm x 4.5 mm,
English: Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse effects of memantine were noted on fertility.
Maltese: Memantine ma kienx teratoġeniku fil-firien u fniek, anki meta d-dożi kienu tossiċi għall-omm, u l-ebda effetti avversi ma dehru b'memantine fuq il-fertilità.
English: Clinical efficacy and safety
Maltese: L-effikaċja u s-sigurtà klinika
English: Fri.
Maltese: kuljum.
English: Each pack with 28 film-coated tablets for a 4 week treatment schedule contains: Week 1: 7 film-coated tablets of Nemdatine 5 mg
Maltese: Kull pakkett bi 28 pillola miksija b'rita għal 4 skeda ta 'trattament ġimgħa fiha: Ġimgħa 1: 7 pilloli miksijin b'rita ta 'Nemdatine 5 mg
English: From the fourth week on, the usual dose is 4 tablets once a day (1x 20 mg).
Maltese: Mir-raba 'ġimgħa fuq, id-doża tas-soltu hija ta' 4 pilloli darba kuljum (1x 20 mg).
English: The recommended dose of Nemdatine for adults and older people is 20 mg once a day.
Maltese: Id-doża rakkomandata ta 'Nemdatine għall-adulti u pazjenti ta' età akbar hija 20 mg darba kuljum.
English: Children and adolescents Nemdatine is not recommended for children and adolescents under the age of 18 years.
Maltese: Tfal u adolexxenti Nemdatine mhux rakkomandat fit-tfal u adolexxenti taħt it-18-il sena.
English: Concomitant Medication checklist
Maltese: Mediċini Kontraindikati li Jingħataw fl-Istess Ħin
English: • That there is a potential risk of teratogenicity and so Eurartesim should not be used in situations where other suitable and effective anti-malarials are available.
Maltese: • Li hemm ir-riskju potenzjali ta' teratoġeniċità u għalhekk Eurartesim m'għandux jintuża f'sitwazzjonijiet fejn mediċini oħrajn adattati u effettivi kontra l-malarja jkunu disponibbli.
English: • The need to counsel patients on important risks associated with Eurartesim therapy and appropriate precautions when using the medicine.
Maltese: • Il-ħtieġa li l-pazjenti jingħataw parir dwar riskji importanti assoċjati mat-terapija b'Eurartesim u l-prekawzjonijiet adattati meta tintuża l-mediċina.
English: • The ECG monitoring recommendations.
Maltese: • Ir-rakkomandazzjonijiet dwar il-monitoraġġ permezz ta' ECG
English: The Member States shall agree the final educational material with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.
Maltese: L-Istati Membri għandhom jaqblu dwar il-materjal edukattiv finali mad-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) qabel it-tnedija tal-prodott fit-territorju tagħhom.
English: No food should be taken within 3 hours after each dose.
Maltese: Lebda ikel m'għandu jittieħed sa 3 sigħat wara kull doża.
English: • The scope and use of the Contraindicated Conditions of Use and Contraindicated Concomitant Medication checklist
Maltese: • L-għan u l-użu tal-Kundizzjonijiet Kontraindikati tal-Użu u l-Lista ta' Mediċini li Jingħataw flIstess Ħin Kontraindikati
English: • That piperaquine absorption is increased in the presence of food, therefore to reduce this risk of QTc interval prolongation, the patients should be advised to take the tablets with water, without food, no less than three hours after the last food intake.
Maltese: • Li l-assorbiment ta' piperaquine jiżdied fil-preżenza tal-ikel u għalhekk, biex jitnaqqas dan irriskju ta' titwil tal-intervall tal-QTc, il-pazjenti għandhom jingħataw parir biex jieħdu l-pilloli mal-ilma, fuq stonku vojt, mhux inqas minn tliet sigħat wara li tkun ittieħdet l-aħħar ikla.
English: The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Eurartesim a healthcare professional educational pack containing the following:
Maltese: Anness Kundizzjonijiet jew restrizzjonijiet fir-rigward ta' l-użu mingħajr periklu u effettiv tal-prodott mediċinali li jridu jiġu implimentati mill-Istati Membri
English: • That patients should be advised to contact their doctor about adverse events and that physicians/pharmacists should report suspected adverse reactions to Eurartesim, and in particular, those associated with a QT prolongation.
Maltese: • Fl-Istati Membri fejn ir-reġistru dwar is-sigurtà tal-UE ser ikun disponibbli, il-materjal edukattiv għandu jinkludi dettalji dwar ir-reġistru u kif il-pazjenti jinkitbu fih.
English: 15 November 2007
Maltese: 15 ta' Novembru 2007
English: Ref. EMEA/CHMP/263995/2009
Maltese: EMEA/263921/2009
English: Depression.
Maltese: Depressjoni.
English: London, 7 April 2009 Doc.
Maltese: Londra, 7 ta' April 2009 Dok. ta' Ref.
English: 1 Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Maltese: 1 L-Artikolu 30 tad-Direttiva 2001/83/KE kif emendata, referenza abbażi ta' deċiżjonijiet diverġenti adottati minn Stati Membri
English: Zoloft contains the active substance sertraline.
Maltese: Zoloft fih is-sustanza attiva sertraline.
English: The maximum dosage is 200 mg daily.
Maltese: Id-doża massima hija ta' 200 mg kuljum.
English: Company responses provided on: 22 February 2008, 10 September 2008, 09 December 2008 Opinion date:
Maltese: Tweġibiet tal-kumpanija pprovduti 22 ta' Frar 2008, 10 ta' Settembru 2008, 09 ta' Diċembru 2008
English: Hepatic Impairment.
Maltese: Indeboliment epatiku.
English: Therapeutic Indication
Maltese: Indikazzjoni Terapewtika
English: Prevention of recurrence of major depressive episodes”
Maltese: Prevenzjoni ta' rikorrenza ta' episodji depressivi maġġuri”
English: What is Zoloft?
Maltese: X'inhu Zoloft?
English: Post-traumatic Stress Disorder:.
Maltese: Disturb ta' Stress Post-Trawmatiku:
English: Obsessive Compulsive Disorder in adults.
Maltese: Disturb Koerċittiv Ossessiv fl-adulti.
English: Zoloft can also be available in the EU and the EEA under other trade names: Tresleen, Serlain, Lustral, Tatig, Sertraline and Besitran.
Maltese: Zoloft jista' jkun disponibbli ukoll fl-UE u ż-ŻEE taħt ismijiet kummerċjali oħrajn: Tresleen, Serlain, Lustral, Tatig, Sertraline u Besitran.
English: Questions and answers on the referral for Zoloft Hard capsules and film coated tablets containing 25 mg, 50 mg or 100 mg sertraline Concentrate for oral solution containing 20 mg/ml sertraline
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Zoloft Kapsuli iebsin u pilloli miksija b'rita li fihom 25 mg, 50 mg jew 100 mg ta' sertraline Konċentrat għal soluzzjoni orali li fih 20 mg/ml ta' sertraline
English: “Sertraline is indicated for the treatment of major depressive episodes.
Maltese: “Sertraline huwa indikat għall-kura ta' episodji depressivi maġġuri.
English: Zoloft can be used in adults to treat depression and prevent recurrence of depression, social anxiety disorder, post traumatic stress disorder (PTSD), panic disorder; and to treat obsessive compulsive disorder (OCD) in adults and children and adolescents, aged 6-17 years old.
Maltese: Zoloft jista' jintuża fl-adulti sabiex jikkura d-depressjoni u jipprevjeni r-rikorrenza tad-depressjoni, iddisturb tal-ansjetà soċjali, id-disturb ta' stress post-trawmatiku (post traumatic stress disorder - PTSD), id-disturb ta' paniku; u għall-kura tad-disturb koerċittiv ossessiv (obsessive compulsive disorderOCD) f'adulti, tfal u adolexxenti, bejn is-6 u 17-il sena.
English: The European Medicines Agency (EMEA) has completed a review of Zoloft.
Maltese: L-Aġenzija Ewropea dwar il-Mediċini (EMEA) temmet reviżjoni ta' Zoloft.
English: The CHMP endorsed the harmonised indication: “Sertraline is indicated for the treatment of post traumatic stress disorder (PTSD)”,
Maltese: Is-CHMP approva l-indikazzjoni armonizzata: “Sertraline huwa indikat għall-kura tad-disturb ta' stress post-trawmatiku (PTSD)”,
English: Paediatric-onset OCD shares important similarities with the adult disorder but also shows important differences.
Maltese: Il-bidu pedjatriku ta' OCD għandu xebħ importanti mad-disturb fl-adulti iżda juri wkoll differenzi importanti.
English: Neurotransmitters are chemicals that transfer chemical signals from one nerve cell to another.
Maltese: In-newrotrasmettituri huma kimiċi li jittrasferixxu sinjali kimiċi minn ċellola tan-nervituri għal oħra.
English: Zoloft is authorised in the European Union (EU) via national procedures.
Maltese: Zoloft huwa awtorizzat fl-Unjoni Ewropea (UE) permezz ta' proċeduri nazzjonali.
English: The CHMP endorsed the harmonised indication: “Panic disorder with or without agoraphobia”.
Maltese: Is-CHMP approva l-indikazzjoni armonizzata: “Disturb tal-paniku bi jew mingħajr agorafobija”.
English: The CHMP endorsed the following: “Concomitant intake of pimozide is contraindicated (see section 4.5)”
Maltese: Is-CHMP approva dan li ġej: “It-teħid fl-istess ħin ta' pimozide huwa kontraindikat (ara sezzjoni 4.5)”
English: The CHMP adopted the following:
Maltese: Is-CHMP adotta dan li ġej:
English: Low levels of serotonin in the central nervous system may be associated with depression or anxiety.
Maltese: Livelli baxxi ta' serotonin fis-sistema nervuża ċentrali jistgħu jkunu assoċjati ma' depressjoni jew ansjetà.
English: Zoloft has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Zoloft ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Reċiproki u Deċentralizzati - Bnedmin (CMD(h)).
English: The CHMP concluded that the safety in children and adolescents has not sufficiently been established and that a commitment to further investigate safety in paediatric patients is required in order to adopt the following indication: “Sertraline is indicated for the treatment of obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years.” with the condition that the following text is inserted in the section 5.1 “Pharmacodynamic Properties” of the SPC: "Long term safety and efficacy data are lacking for this paediatric population.
Maltese: Is-CHMP ikkonkluda li s-sigurtà fit-tfal u fl-adolexxenti ma ġietx stabbilita biżżejjed u li hemm bżonn ta' impenn biex issir investigazzjoni ulterjuri tas-sigurtà f'pazjenti pedjatriċi sabiex tiġi adottata lindikazzjoni li ġejja: “Sertraline huwa indikat għall-kura tad-disturb koerċittiv ossessiv (OCD) fl-adulti u f'pazjenti pedjatriċi ta' bejn is-6 u s-17-il sena.” bil-kundizzjoni li l-kliem li ġej jiddaħħal fis-sezzjoni 5.1 “Tagħrif farmakodinamiku” tal-SPC:
English: The CHMP also discussed this indication.
Maltese: Is-CHMP iddiskuta wkoll din l-indikazzjoni.
English: Sertraline is a selective serotonin re-uptake inhibitor (SSRI), It works by preventing the neurotransmitter serotonin from being taken back up into nerve cells in the brain and spinal cord.
Maltese: Sertraline huwa inibitur selettiv tat-teħid mill-ġdid ta' serotonin (selective serotonin re-uptake inhibitor - SSRI).
English: Prevention of relapse and recurrence was proposed during the assessment by the CHMP.
Maltese: Il-prevenzjoni tar-rikaduta u tar-rikorrenza kienet proposta waqt l-evalwazzjoni misCHMP.
English: Why was Zoloft reviewed?
Maltese: Għaliex ġie rivedut Zoloft?
English: Considering the incidence of adverse events in PTSD, the CHMP agreed that the safety of sertraline in the treatment of PTSD is similar to that of major depressive disorder and does not present any new issues.
Maltese: Meta wieħed jikkunsidra l-inċidenza ta' avvenimenti avversi f'PTSD, is-CHMP qabel li s-sigurtà ta' sertraline fil-kura ta' PTSD hija simili għal dik ta' disturb depressiv maġġuri u li dan ma jippreżentax xi kwistjonijiet ġodda.
English: Panic disorder with or without agoraphobia disorder.
Maltese: Disturb tal-paniku bi jew mingħajr disturb tal-agorafobija.
English: Data from the clinical programme for the indication PTSD were submitted and the results showed that only two of the four studies demonstrated efficacy.
Maltese: Ġiet sottomessa dejta mill-programm kliniku għall-indikazzjoni PTSD u r-riżultati wrew li tnejn biss mill-erba' studji wrew effikaċja.
English: Therefore the CHMP endorsed the following indication: “Sertraline is indicated for the treatment of obsessive compulsive disorder (OCD) in adults”,
Maltese: Għaldaqstant is-CHMP approva l-indikazzjoni li ġejja: “Sertraline huwa indikat għall-kura tad-disturb koerċittiv ossessiv (OCD) fl-adulti”,
English: Noting that major depression is considered to be a chronic or chronic intermittent condition, the CHMP considered it unnecessary to accept this separate indication.
Maltese: Minħabba li nnota li d-depressjoni maġġuri hija kkunsidrata bħala kundizzjoni kronika jew kundizzjoni intermittenti kronika, is-CHMP ma ħassx il-bżonn li jaċċetta din l-indikazzjoni separata.
English: The clinical programme for the indication OCD was submitted and sertraline demonstrated a modest short-term effect and no safety concerns.
Maltese: Ġie sottomess il-programm kliniku għall-indikazzjoni OCD u sertraline wera effett modest fuq żmien qasir u ma wera l-ebda tħassib dwar is-sigurtà.
English: The CHMP, considered the benefit/risk balance, approved the following indication: “Sertraline is indicated for the treatment of social anxiety disorder”.
Maltese: Is-CHMP, wara li kkunsidra l-bilanċ bejn il-benefiċċju u r-riskju, approva l-indikazzjoni li ġejja: “Sertraline huwa indikat għall-kura tad-disturb tal-ansjetà soċjali”.
English: Regarding the use of sertraline in Hepatic Insufficiency and in Renal Insufficiency, the CHMP agreed with the wording proposed by the MAH for harmonisation.
Maltese: Rigward l-użu ta' sertraline fl-Insuffiċjenza Epatika u fl-Insuffiċjenza Renali, is-CHMP qabel malkliem propost mill-MAH għall-armonizzazzjoni.
English: However, the generally lower body weights of children compared to those of adults should be taken into consideration when increasing the dose from 50 mg.
Maltese: Madankollu, il-piżijiet tal-ġisem ġeneralment aktar baxxi fit-tfal meta mqabbla ma' dawk tal-adulti għandhom jiġu kkunsidrati meta wieħed iżid id-doża minn 50 mg.
English: Obsessive Compulsive Disorder in paediatric patients .In order to support the paediatric indication, one single study was submitted including children and adolescents aged 6-17.
Maltese: Bħala appoġġ għall-indikazzjoni pedjatrika, ġie sottomess studju waħdieni li kien jinkludi tfal u adolexxenti bejn is-6 u s-17-il sena.
English: The CHMP discussed the results of the clinical programme that showed a significant improvement in reducing panic attacks.
Maltese: Is-CHMP iddiskuta r-riżultati talprogramm kliniku li wera titjib sinifikanti fit-tnaqqis tal-attakki ta' paniku.
English: The CHMP concluded that short-term efficacy has been demonstrated, but that concerns remain over the lack of evidence with respect to relapse.
Maltese: Is-CHMP ikkonkluda li l-effikaċja fuq żmien qasir intweriet, iżda jibqa' tħassib dwar in-nuqqas ta' evidenza fir-rigward ta' rikaduta.
English: The European Commission issued a decision on 27 March 2009.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fis-27 ta' Marzu 2009.
English: “Subsequent doses may be increased in case of less than desired response in 50 mg increments over a period of some weeks, as needed.
Maltese: “Dożi sussegwenti jistgħu jiżdiedu f'każ ta' rispons inqas minn dak mixtieq f'żidiet ta' 50 mg fuq perijodu ta' xi ġimgħat, kif meħtieġ.
English: Although the safety profile of sertraline is acceptable, the CHMP implemented the section ‘Posology and Method of Administration' of the SPC, to indicate that the need for continued treatment should be regularly evaluated.
Maltese: Għalkemm il-profil ta' sigurtà ta' sertraline huwa aċċettabbli, isCHMP implimenta s-sezzjoni ‘Pożoloġija u Metodu ta' Kif Għandu Jingħata' tal-SPC, sabiex jindika li l-ħtieġa għal kura kontinwa għandha tkun evalwata b'mod regolari.
English: Burgwedel Biotech GmbH Im Langen Felde 5
Maltese: Burgwedel Biotech GmbH Im Langen Felden 5
English: Date of last renewal: 13/12/2013
Maltese: Data tal-aħħar tiġdid: 13/12/2013
English: ATCvet code: QI09AA07.
Maltese: QI09AA07
English: The NETHERLANDS
Maltese: L-Olanda
English: 30938 Burgwedel GERMANY
Maltese: 30938 Burgwedel Ġermanja
English: 100 ml 200 ml 500 ml 10 x 20 ml 10 x 50 ml 10 x 100 ml 10 x 200 ml 10 x 500 ml
Maltese: 200 ml 500 ml 10 x 20 ml 10 x 50 ml 10 x 100 ml 10 x 200 ml 10 x 500 ml
English: EU/2/08/091/003 100 ml EU/2/08/091/004 200 ml EU/2/08/091/005 500 ml EU/2/08/091/006 10 x 20 ml EU/2/08/091/007 10 x 50 ml EU/2/08/091/008 10 x 100 ml EU/2/08/091/009 10 x 200 ml EU/2/08/091/010 10 x 500 ml
Maltese: EU/2/08/091/003 100 ml EU/2/08/091/004 200 ml EU/2/08/091/005 500 ml EU/2/08/091/006 10 x 20 ml EU/2/08/091/007 10 x 50 ml
English: Dl-α-tocopheryl acetate
Maltese: D1-α-tocopheryl acetate
English: 25 mg dl-α-tocopheryl acetate
Maltese: 25mg D1-α-tocopheryl acetate
English: 346 mg light liquid paraffin.
Maltese: 346mg Paraffina likwida ħafifa
English: Simethicon
Maltese: Simetikon
English: Dl-α-tocopheryl acetate Light liquid paraffin Polysorbate 80
Maltese: D1-α-tocopheryl acetate Paraffina likwida ħafifa Polisorbejt 80
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12/01/2009.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 12/01/2009
English: Vaccine to stimulate active immunity against porcine circovirus type 2.
Maltese: Vaċċin biex jistimula immunità attiva kontra l-virus tal-circovirus fil-ħnieżer tip 2.
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer L-Olanda
English: Avoid introduction of contamination.
Maltese: Evita li tinroduċi kontaminazzjoni.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għall-użu intramoskulari
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' l-ingredjenti mhux attivi, ara sezzjoni 6.1.
English: Porcine circovirus type 2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units.
Maltese: Circovirus tal-ħnieżer tip 2 ORF2 subunit tal-antiġen: tal-anqas 4.5 log2 ELISA units
English: When it is expected that higher levels of maternally derived antibodies against PCV2 are present, the following schedule of two vaccinations is advised: the first injection (2 ml) can be given from an age of 3-5 days, the second injection (2 ml) 2-3 weeks later.
Maltese: Meta huwa mistenni li livelli għola ta' antikorpi derivati mill-omm kontra l-PCV2 huma preżenti, liskema li ġejja ta' żewġ vaċċinazzjonijiet hija rrakomandata: l-ewwel injezzjoni (2ml) tista' tingħata mill-età ta' 3-5 ijiem, u t-tieni injezzjoni (2ml) 2-3 ġimgħat wara.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti)jekk ikun hemm bżonn
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 hija fil-prinċipju ta' oriġini bioloġika intenzjonata li tipproduċi immunità attiva, u għaldaqstant ma taqax taħt ir-Regolament tal-Kunsill (EC) No 470/2009.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: Is-sustanzi mhux attivi(inkulżi l-aġġuvanti) msemmija f'sezzjoni 6.1 tal-KPQ huma jew sustanzi permessi li t-tabella 1 tal-anness tar-Regoli tal-Kumissjoni (EU) No 37/2010 turi li m'hemmx bżonn MRL's jew li huma kunsidrati li ma jaqgħux taħt l-iskop tar-Regolamenti (EC) No 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Pack sizes: cardboard boxes with either 1 or 10 vials of 20, 50, 100, 200 or 500 ml (10, 25, 50, 100 or 250 doses).
Maltese: Daqs tal-pakkett: kaxxi tal-kartun b'1 jew 10 kunketti ta' 20, 50, 100, 200 jew 500 ml.(10.25,50,100 jew 250 dożi)
English: This veterinary medicinal product contains mineral oil.
Maltese: Dan il-prodott veterinarju fih żejt minerali.
English: In the event of such reactions, treatment may be needed.
Maltese: F'każ ta' rejazzjonijiet simili, jista' jkun hemm bżonn ta' trattament.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U L
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 tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.emea.europa.eu)
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.emea.europa.eu/
English: PCV2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units.
Maltese: PCV2 ORF2 subunits tal-antiġen:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Per 2 ml dose:
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI Għall kull doża ta' 2 ml:
English: High levels of MDA may be expected when sows/gilts are vaccinated against PCV2 virus or when sows/gilts have recently been exposed to high levels of PCV2 virus.
Maltese: Livelli ogħla ta' antikorpi li ġejjin mill-omm huma mistennija meta l-majjaliet/qżieqeż huma vaċċinati kontra l virus tal-PVC2 jew jekk il-majjaliet/qżieqeż ġew esposti għall-livelli għolja tal-virus PVC2.
English: Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units* * Antibody titre obtained according to the in vivo potency test in chickens.
Maltese: Subunit tal-antiġen ta' Circovirus tal- ħnieżer tip 2 ORF2: tal-anqas 4.5 log2 ELISA units* *Tajter tal-antikorpi miksub minn testijiet ta' potenza in vivo fil-flieles.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/091/001-010
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/08/091/001-010
English: Emulsion for injection.
Maltese: Emulsjoni għal injezzjoni
English: Each dose of 2 ml contains:
Maltese: Kull doża ta' 2 ml: