FrancophonIA/ELRC3.0 huggingface dataset:
English: Opdivo is used on its own after treatment with brentuximab vedotin (another cancer medicine);
Maltese: Opdivo jintuża waħdu wara kura bi brentuximab vedotin (mediċina oħra kontra l-kanċer);
English: For squamous NSCLC, a study involving 272 adults showed that patients given Opdivo survived for 9.2 months, compared with 6.0 months in patients given docetaxel.
Maltese: Għal NSCLC skwamuż, studju li involva 272 adult wera li l-pazjenti li ngħataw Opdivo għexu madwar 9.2 xhur, meta mqabbla ma' 6.0 xhur fil-pazjenti li ngħataw docetaxel.
English: Opdivo was investigated in one main study involving 361 adults with SCCHN whose cancer progressed despite previous treatment with platinum medicines.
Maltese: Opdivo kien investigat fi studju ewlieni li involva 361 adult b'SCCHN li l-kanċer tagħhom mar għallagħar minkejja kura preċedenti b'mediċini tal-platinu.
English: One main study involving 1,096 adults with previously untreated advanced renal cell carcinoma compared treatment with Opdivo and ipilimumab versus treatment with another cancer medicine for renal cell carcinoma, sunitinib.
Maltese: Studju ewlieni li involva 1,096 adult b'karċinoma avvanzata taċ-ċelloli renali li ma kinitx ġiet ikkurata qabel qabbel il-kura b'Opdivo u b'ipilimumab ma' kura b'mediċina oħra kontra l-kanċer għal karċinoma taċ-ċelloli renali, sunitinib.
English: The first study, involving 418 previously untreated advanced melanoma patients, found that patients treated with Opdivo survived longer than patients who received the cancer medicine dacarbazine: 73% of patients treated with Opdivo were alive at 12 months compared with 42% of patients given dacarbazine.
Maltese: L-ewwel studju li involva 418-il pazjent li ma kinux ġew ikkurati qabel għal melanoma avvanzata, sab li l-pazjenti kkurati b'Opdivo għexu iktar mill-pazjenti li ngħataw il-mediċina kontra l-kanċer dacarbazine: 73 % tal-pazjenti kkurati b'Opdivo kienu ħajjin fit-12-il xahar meta mqabbla ma' 42 % tal-pazjenti li ngħataw dacarbazine.
English: • advanced renal cell carcinoma, a kidney cancer.
Maltese: • karċinoma avvanzata taċ-ċelloli renali, kanċer tal-kliewi.
English: More patients were alive after 2 years with Opdivo and ipilimumab treatment (64%) than with Opdivo alone (59%) or ipilimumab alone (45%).
Maltese: Aktar pazjenti baqgħu ħajjin wara sentejn kura b'Opdivo u b'ipilimumab (64 %) milli b'Opdivo waħdu (59 %) jew b'ipilimumab waħdu (45 %).
English: In the study, 20% of patients (54 out of 270) responded to treatment and had a tumour size reduction.
Maltese: Fl-istudju, 20 % tal-pazjenti (54 minn 270) irrispondew għall-kura u tnaqqsilhom id-daqs tat-tumur.
English: Other common side effects with Opdivo in combination with ipilimumab, which are also mostly mild or moderate, include pyrexia (fever), thyroid issues, decreased appetite, vomiting, colitis (inflammation of the gut), abdominal (belly) pain, headache and breathing difficulty.
Maltese: Effetti sekondarji komuni oħra b'Opdivo f'kombinazzjoni ma' ipilimumab, li huma wkoll filbiċċa l-kbira ħfief jew moderati, jinkludu piressija (deni), kwistjonijiet bit-tirojde, nuqqas ta' aptit, remettar, kolite (infjammazzjoni tal-imsaren), ugigħ addominali (fiż-żaqq), uġigħ ta' ras u diffikultà fitteħid tan-nifs.
English: The most common side effects with Opdivo (which may affect more than 1 in 10 people) include tiredness, diarrhoea, nausea (feeling sick), rash and itching, pain in joints, muscles and bones, and hypothyroidism (an underactive thyroid gland), most of which are mild to moderate in severity.
Maltese: L-effetti sekondarji l-aktar komuni b'Opdivo (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) jinkludu għeja, dijarrea, nawsja (tħossok ma tiflaħx), raxx u prurite, uġigħ fil-ġogi, fil-muskoli u flgħadam, u ipotirojdiżmu (glandola tirojde li taħdem bil-mod), li ħafna minnhom huma ħfief sa moderati fis-severità.
English: Opdivo is given as an infusion (drip) into a vein.
Maltese: Opdivo jingħata bħala infużjoni (dripp) ġol-vina.
English: The company that markets Opdivo will provide educational packs for doctors who are expected to prescribe Opdivo containing information on how the medicine should be used, how to manage side effects, particularly those related to the activity of the immune system, and possible risks for classical Hodgkin lymphoma patients if they go on to have an allogeneic stem cell transplant (a transplant of stem cells from a donor).
Maltese: Il-kumpanija li tipproduċi Opdivo ser tipprovdi pakketti edukattivi għat-tobba li huma mistennija jippreskrivu Opdivo, li jkun fihom informazzjoni dwar kif għandha tintuża l-mediċina, kif għandhom jiġu ġestiti l-effetti sekondarji, b'mod partikolari dawk relatati mal-attività tas-sistema immunitarja, u rriskji possibbli għall-pazjenti b'limfoma ta' Hodgkin klassika jekk isirilhom trapjant alloġeniku taċ-ċelluli staminali (trapjant taċ-ċelluli staminali minn donatur).
English: Opdivo was compared with everolimus (another cancer medicine) in one main study involving 821 patients with advanced renal cell carcinoma whose disease advanced despite previous treatment.
Maltese: Opdivo tqabbel ma' everolimus (mediċina oħra kontra l-kanċer) fi studju ewlieni li involva 821 pazjent b'karċinoma avvanzata taċ-ċelloli renali li l-marda tagħhom aggravat minkejja kura preċedenti.
English: As for all medicines, data on the use of Opdivo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Opdivo hija ssorveljata kontinwament.
English: The time patients lived before their disease got worse was 11.6 months with the combination compared with 8.4 with sunitinib.
Maltese: Iż-żmien li l-pazjenti għexu qabel ma l-marda tagħhom qalbet għall-agħar kien 11.6 xhur bilkombinazzjoni meta mqabbel ma' 8.4 xhur b'sunitinib.
English: Patients given Opdivo survived on average for 7.5 months, compared with 5.1 months in patients given other treatments.
Maltese: Il-pazjenti li ngħataw Opdivo għexu madwar 7.5 xhur, meta mqabbla ma' 5.1 xhur f'pazjenti li ngħataw kuri oħra.
English: • classical Hodgkin lymphoma, a cancer of the lymphocytes (a type of white blood cell), that has not improved or has returned after an autologous stem cell transplant (a procedure where the bone marrow is replaced with the patient's own stem cells to form new bone marrow that produces healthy blood cells).
Maltese: • linfoma ta' Hodgkin klassika, kanċer tal-limfoċiti (tip ta' ċellula bajda tad-demm), li ma marx għallaħjar jew li reġa' tfaċċa wara trapjant awtologu taċ-ċelluli staminali (proċedura fejn il-mudullun jiġi sostitwit biċ-ċelluli staminali tal-pazjenti stess sabiex jifforma mudullun ġdid li jipproduċi ċelluli tad-demm b'saħħithom).
English: The average survival with Opdivo was 12.2 months, compared with 9.4 months with docetaxel.
Maltese: Is-sopravivenza medja b'Opdivo kienet 12.2 xhur, meta mqabbla ma' 9.4 xhur b'docetaxel.
English: Patients given Opdivo survived for 25.0 months, compared with 19.6 months for patients given everolimus.
Maltese: 0 xhur, meta mqabbla ma' 19.6 xhur f'pazjenti li ngħataw everolimus.
English: After treatment, cancer cells were partially or completely cleared in around 66% of patients (63 out of 95).
Maltese: Wara l-kura, iċ-ċelluli tal-kanċer tneħħew parzjalment jew kompletament f'madwar 66 % talpazjenti (63 minn 95).
English: The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms.
Maltese: Il-kumpanija ser tipprovdi wkoll kard ta' twissija għall-pazjenti b'informazzjoni dwar ir-riskji tal-mediċina, kif ukoll struzzjonijiet dwar meta għandhom jikkuntattjaw lit-tabib tagħhom jekk jesperjenzaw sintomi.
English: Opdivo was investigated in one main study involving 270 adults with urothelial cancer whose cancer got worse or returned despite previous treatment with platinum medicines.
Maltese: Opdivo kien investigat fi studju ewlieni li involva 270 adult b'kanċer uroteljali li l-kanċer tagħhom qaleb għall-agħar jew reġa' tfaċċa minkejja kura preċedenti b'mediċini tal-platinu.
English: Opdivo was studied in one main study and a supportive study involving a total of 95 adults with classical Hodgkin lymphoma whose disease had not responded or had returned after autologous stem cell transplantation and treatment with brentuximab vedotin.
Maltese: Opdivo ġie studjat fi studju ewlieni u fi studju ta' appoġġ li involva total ta' 95 pazjent b'limfoma ta' Hodgkin klassika li l-marda tagħhom ma rrispondietx jew reġgħet tfaċċat wara trapjant awtologu taċċelluli staminali u kura bi brentuximab vedotin.
English: Patients who were given Opdivo plus ipilimumab lived for another 11.5 months without their disease getting worse and patients given only Opdivo lived for another 6.9 months without their disease getting worse.
Maltese: Il-pazjenti li ngħataw Opdivo flimkien ma' ipilimumab għexu 11.5 xhur oħra mingħajr ma l-marda tagħhom qalbet għallagħar u l-pazjenti li ngħataw Opdivo biss għexu 6.9 xhur oħra mingħajr ma l-marda tagħhom qalbet għall-agħar.
English: By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Maltese: Billi teħel marriċettur, in-nivolumab tipprevjeni PD-L1 u PD-L2 milli jitfu ċ-ċelluli T, b'hekk tiżdied l-abilità tassistema immunitarja biex toqtol iċ-ċelluli tal-kanċer.
English: In this study, where patients were followed up for at least 6 months, around 32% (38 out of 120) of patients given Opdivo responded to treatment and had a reduction in their tumours compared with about 11% (5 out of 47) of patients given investigator's choice of treatment (dacarbazine or a combination of carboplatin and paclitaxel).
Maltese: F'dan l-istudju, fejn il-pazjenti ġew segwiti għal tal-inqas 6 xhur, madwar 32 % (38 minn 120) tal-pazjenti li ngħataw Opdivo rrispondew għall-kura u kellhom tnaqqis fit-tumuri tagħhom meta mqabbla ma' madwar 11 % (5 minn 47) tal-pazjenti li ngħataw l-għażla ta' kura tal-investigatur (dacarbazine jew kombinazzjoni ta' carboplatin u paclitaxel).
English: How is Opdivo used?
Maltese: Kif jaħdem Opdivo?
English: • urothelial cancer, a cancer of the bladder and urinary tract, that has spread locally and cannot be surgically removed or has spread to other parts of the body.
Maltese: • kanċer uroteljali, kanċer tal-bużżieqa u l-kanal tal-awrina, li jkun infirex lokalment u li ma jistax jitneħħa b'kirurġija jew ikun infirex ma' partijiet oħra tal-ġisem.
English: • a lung cancer called non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body.
Maltese: • kanċer taċ-ċelluli skwamużi tar-ras u tal-għonq (SCCHN) li reġa' tfaċċa jew li jkun infirex ma' partijiet oħra tal-ġisem.
English: The active substance in Opdivo, nivolumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells.
Maltese: Is-sustanza attiva f'Opdivo, in-nivolumab, hija antikorp monoklonali, tip ta' proteina li tfasslet sabiex tagħraf u teħel ma' riċettur (mira) imsejjaħ PD-1 li jinsab fuq ċerti ċelluli tas-sistema immunitarja msejħin ċelluli T. Iċ-ċelluli tal-kanċer jistgħu jipproduċu proteini (PD-L1 u PD-L2) li jeħlu ma' dan irriċettur u jitfu l-attività taċ-ċelluli T, b'hekk jipprevjenuhom milli jattakkaw il-kanċer.
English: Studies of classical Hodgkin lymphoma involved only a small number of patients.
Maltese: Listudji tal-limfoma ta' Hodgkin klassika involvew biss numru żgħir ta' pazjenti.
English: A fourth study in 945 previously untreated advanced melanoma adult patients investigated Opdivo in combination with ipilimumab, Opdivo used alone or ipilimumab used alone.
Maltese: It-tieni studju eżamina 405 pazjenti b'melanoma avvanzata li l-marda tagħhom qalbet għall-agħar minkejja kura preċedenti b'mediċina kontra l-kanċer.
English: Opdivo is used on its own or with another cancer medicine, ipilimumab, to treat adults whose cancer has spread to other parts of the body or cannot be surgically removed.
Maltese: Opdivo jintuża waħdu jew ma' mediċina oħra kontra l-kanċer, ipilimumab, għall-kura ta' adulti li l-kanċer tagħhom infirex ma' partijiet oħra tal-ġisem u ma jistax jitneħħa b'kirurġija.
English: A third study in 906 adults with melanoma who had undergone surgery and who were at high risk of the cancer coming back compared Opdivo with ipilimumab.
Maltese: It-tielet studju f'906 pazjenti b'melanoma li kienu diġa' għaddew minn kirurġija u li kienu f'riskju kbir li l-kanċer jerġa' jitfaċċa qabbel Opdivo ma' ipilimumab.
English: For the full list of side effects and restrictions with Opdivo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Opdivo, ara l-fuljett ta' tagħrif.
English: Sorbitol 70% (solution)
Maltese: Sorbitol 70% (soluzzjoni)
English: DIVA tests:
Maltese: Testijiet DIVA:
English: Date of first authorisation: 10/02/2015.
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 10/02/2015.
English: * min 100 PD50 ** Tissue culture infectious dose
Maltese: * min 100 PD50 ** Doża infettiva tal-kultura tat-tessut
English: L2 Freeze-drying Stabilizer composed as follows Dextran 40
Maltese: L2 Freeze-drying Stabilizer magħmul minn Dextran 40
English: See section 4.4
Maltese: Ara sezzjoni 4.4
English: EU/2/14/179/001-002
Maltese: FIS-SUQ EU/2/14/179/001-002
English: 10 doses 50 doses
Maltese: 10 dożi 50 doża
English: Lot {number}
Maltese: JISK {xahar/sena}
English: EU/2/14/179/001 (10 doses) EU/2/14/179/002 (50 doses)
Maltese: EU/2/14/179/002 (50 doża)
English: Solvent for Suvaxyn CSF Marker
Maltese: VETERINARJU Solvent għal Suvaxyn CSF Marker
English: Lyophilisate:
Maltese: Tqala:
English: Limited studies in young pigs support protection against CSF1045 (genotype 2, Germany 2009) and CSF1047 (genotype 2, Israel 2009) field strains.
Maltese: Studji limitati fi ħnieżer żgħar jappoġġjaw il-protezzjoni kontra l-istrejns tal-marda CSF1045 (genotip 2, Ġermanja 2009) u CSF1047 (genotip 2, Iżrael 2009).
English: Sodium chloride 9 mg/ml Water for injections q.s.p.
Maltese: Kloru tas-sodju 9 mg/ml Ilma għall-injezzjonijiet q.s.p. 1 ml
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta ġo friġġ (2 °C - 8 °C)
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U
English: Name and address of the manufacturers of the biological active substance
Maltese: Isem u indirizz tal-manufatturi tas-sustanza bioloġika attiva
English: 6.2 Major Incompatibilities
Maltese: .2 Inkompatibilitajiet maġġuri
English: To stimulate active immunity to Classical Swine Fever virus.
Maltese: Biex jistimola l-immunità attiva għall-virus tal-Classical Swine Fever.
English: Sodium chloride solution 9 mg/ml
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Soluzzjoni tal-kloru tas-sodju 9 mg/ml
English: Live recombinant CP7-E2Alf:
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Rikombinat ħaj (CP7-E2Alf)
English: 104.8 to 106.5 TCID50
Maltese: 104.8 sa 106.
English: Challenge studies were conducted with the Koslov strain (genotype 1) of CSFV.
Maltese: Studji ta' sfida tmexxew bl-istrejn ta' Koslov (genotip 1) tal-CSFV.
English: Pharmacotherapeutic group: live viral vaccines, live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene, ATC vet code: QI09AD04
Maltese: Grupp farmako-terapewtiku: vaċċini virali ħajjin, virus ħaj tal-Bovine Viral Dirrhoea rikombinat mingħajr il-ġin E2 li fih il-ġin tal-Classical Swine Fever E2, Kodici ATĊ veterinarja:
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Lyophilisate: Off-white pellet
Maltese: Pellit offwajt
English: Live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene (CP7_E2alf)
Maltese: Virus rikombinat ħaj tal-Bovine Viral Dirrhoea mingħajr il-ġin E2 li fih il-ġin tal-Classical Swine Fever E2 (CP7_E2alf)
English: Serological DIVA tools based on detection of CSFV antibodies other than those raised against E2, such as Erns antibody detection should be able to differentiate between antibody responses against Erns-BVDV after solely herd vaccination with CP7_E2alf from responses against Erns-CSFV after natural field CSFV infection.
Maltese: Għodda sjeroloġika DIVA ibbażata fuq l-għarfien ta' antikorpi CSFV barra minn dawk iffurmati kontra E2, bħal għarfien tal-antikorpi ta' Erns, għandha tkun tista' tagħraf bejn rispons tal-antikorpi kontra ErnsBVDV wara tilqim biss tal-merħla b'CP7_E2alf u rispons kontra Erns-CSFV wara infezzjoni talmarda naturali tal-CSFV.
English: Type I hydrolytic glass vials containing 10 or 50 doses of lyophilisate and 10 or 50 ml of solvent.
Maltese: Kunjetti tal-ħġieġ tat-Tip I hydrolytic li fihom 10 jew 50 doża ta' lijofiliżżat u 10 jew 50 ml ta' solvent.
English: Onset of immunity: 14 days after vaccination Duration of immunity: at least 6 months after vaccination
Maltese: Bidu tal-immunità: 14-il jum wara t-tilqima Tul tal-immunità: tal-anqas 6 xhur wara t-tilqima
English: b) the manipulation, manufacture, storage, supply, distribution and sale of classical swine fever vaccines must be carried out under supervision and in accordance with the eventual instructions established by the competent authority of the Member State.
Maltese: b) Il-manipulazzjoni, il-manifattura, il-ħażna, il-provvista, id-distribuzzjoni u il-bejgħ ta' vaċċini kontra l-classical swine fever għandhom isiru taħt is-supervizzjoni u skont struzzjonijiet li eventwalment jiġu stabbiliti mill-awtorità kompetenti tal-Istat Membru.
English: Therefore, sows should not be vaccinated, due to the risk of birth of immunotolerant persistently infected offspring.
Maltese: Għalhekk il-majjaliet m'għandhomx jiġu mlaqqma minħabba fir-riskju ta' wlied li jkunu immunotolleranti u infettati b'mod persistenti.
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 li hija prinċipju ta' oriġini bioloġiku maħsuba sabiex tipproduċi immunità attiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: Pregnancy:
Maltese: Inkompatibilitajiet:
English: Lyophilisate
Maltese: KARATTERISTIĊI
English: 104.8* to 106.5 TCID**50
Maltese: 104.8* sa 106.
English: C. STATEMENT OF THE MRLs
Maltese: DIKJARAZZJONI TA' L-MRLs
English: Cardboard box containing 1 vial with 50 doses of lyophilisate and 1 vial with 50 ml solvent.
Maltese: Kaxxa tal-kartun li fiha kunjett 1 b'50 doża ta' lijofiliżżat u kunjett wieħed b'50 ml ta' solvent.
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 mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Vaccine virus genome is rarely detectable by RT-PCR in tonsils and lymph nodes for up to 63 days after vaccination and vaccine virus is very rarely detectable by virus isolation in tonsil for the first week after vaccination.
Maltese: Il-genome tal-virus mill-vaċċin rari li jinqabad permezz ta' RT-PCR fit-tunsilli u l-lymph nodes sa 63 jum wara t-tilqim u l-virus mill-vaċċin rari jinqabad permezz ta' iżolament tal-virus mit-tunsilli sa ġimgħa wara t-tilqim.
English: Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs
Maltese: VETERINARJU Suvaxyn CSF Marker lijofiliżat u solvent għal sospensjoni għall-injezzjoni fil-ħnieżer
English: Suvaxyn CSF Marker lyophilisate for suspension for injection for pigs
Maltese: VETERINARJU Suvaxyn CSF Marker lijofiliżat għal sospensjoni għall-injezzjoni fil-ħnieżer
English: QUANTITY OF THE ACTIVE SUBSTANCES
Maltese: Sustanza Attiva:
English: Council Directive 2001/89/EC and Commission Decision 2002/106 prohibit prophylactic vaccination within the European Union.
Maltese: Id-Direttiva tal-Kunsill 2001/89/KE u d-Deċizzjoni tal-Kummissjoni 2002/106 tipprojbixxi t-tilqim profilattiku fl-Unjoni Ewropeja.
English: Studies in vaccinated breeding boars addressing potential shedding of virulent challenge virus in semen have not been conducted.
Maltese: Ma sarux studji li indirizzaw il-potenzjal għal tixrid tal-virus ta' sfida virulenti fl-isperma ta' ifħla għat-tgħammir imlaqqma.
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: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma 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 huma ikunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: Cardboard box containing 1 vial with 10 doses of lyophilisate and 1 vial with 10 ml solvent.
Maltese: Kaxxa tal-kartun li fiha kunjett 1 b'10 dożi ta' lijofiliżżat u kunjett wieħed b'10 ml ta' solvent.
English: The vaccine is a live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene.
Maltese: Il-vaċċin huwa virus ħaj tal-Bovine Viral Dirrhoea rikombinat mingħajr il-ġin E2 li fih il-ġin talClassical Swine Fever E2.
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: a) the use of classical swine fever vaccines is prohibited.
Maltese: a) l-użu ta' vaċċini kontra l-classical swine fever huma projbiti.
English: Basic vaccination
Maltese: GĦAMLA FARMAĊEWTIKA
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial label (10 and 50 doses)
Maltese: Tikketta tal-kunjett tal-lijofiliżżat (10 u 50 doża)
English: Active substance: Lyophilisate:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull doża ta' 1 ml fiha:
English: Date of last renewal:
Maltese: Data tal-aħħar tiġdid:
English: Lyophilisate and solvent for suspension for injection.
Maltese: Lijofiliżat u solvent għal sospensjoni għall-injezzjoni
English: 1ml
Maltese: ANNESS I
English: Challenge studies have shown lack of protection against transplacental transmission of CSFV.
Maltese: Studji ta' sfida wrew nuqqas ta' protezzjoni kontra trasmissjoni tal-CSFV li tgħaddi mill-plaċenta.
English: Disposal: read package leaflet.
Maltese: Wara r-rikostituzzjoni, is-sospensjoni għandha tkun likwidu ċar ħarira fir-roża.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial (10 and 50 ml)
Maltese: Kunjett tas-solvent (10 u 50 ml)
English: For active immunisation of pigs from 7 weeks of age onwards to prevent mortality and reduce infection and disease caused by classical swine fever virus (CSFV).
Maltese: Għat-tilqim attiv ta' ħnieżer minn età ta' 7 ġimgħat ‘il fuq biex tħares kontra l-mortalità u tnaqqas linfezzjoni u l-mard ikkawżat mill-virus tal-classical swine fever.
English: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM
Maltese: 4.7 Użu fit-tqala, fit-treddigħ u fi żmien il-bidien
English: PHARMACEUTICAL INDUSTRY Proel Epam.
Maltese: INDUSTRY PROEL EPAM.
English: Rafarm Aebe Korinthou 12, Neo Psychiko,
Maltese: AEBE korinthou 12, Neo Psychiko,
English: Pharmaceutical Products Ltd,
Maltese: S.M. Pharmaceutical Products Ltd,
English: 92931 Paris La Défense Cedex FRANCE
Maltese: 92931 Paris La Défense Cedex
English: Diagonal, 67-69 08019 Barcelona Spain
Maltese: Diagonal, 67-69 08019 Barcelona ESPAÑA
English: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest FRANCE
Maltese: SAS 117, allée des Parcs 69800 Saint-Priest France