FrancophonIA/ELRC3.0 huggingface dataset:
English: United Kingdom HEC Pharm GmbH
Maltese: Il-Ġermanja HEC Pharm GmbH
English: bupropion
Maltese: bupropjon
English: Memantine Dawa 10mg filmcoated tablets memantine
Maltese: Memantine Dawa 10 mg filmcoated tablets memantina
English: hydrocortisone
Maltese: idrokortiżon
English: Voriconazol Aurovitas voriconazol
Maltese: Voriconazol Aurovitas vorikonażol
English: Betahistin HEXAL 16 mg Tabletten
Maltese: Betahistin HEXAL 16 mg Tabletten betahistina
English: Bupropion Sandoz 300 mgTablette mit veränderter Wirkstofffreisetzung bupropion
Maltese: Bupropion Sandoz 300 mg - Tablette mit veränderter Wirkstofffreisetzung bupropjon
English: Bupropion Sandoz bupropion
Maltese: Bupropion Sandoz bupropjon
English: Memantine Dawa 20mg filmcoated tablets memantine
Maltese: Memantine Dawa 20 mg filmcoated tablets memantina
English: Paracetamol 1000mg Tablets paracetamol
Maltese: Paracetamol 1000 mg Pilloli paraċetamol
English: Tadalafil Milpharm 2.5 mg film-coated tablets
Maltese: Tadalafil Milpharm 2.5 mg filmcoated tablets
English: Aripiprazole 10 mg tablets aripiprazole
Maltese: Aripiprazole 10 mg pilloli aripiprażol
English: Aripiprazole 5 mg tablets aripiprazole
Maltese: Aripiprazole 5 mg pilloli aripiprażol
English: Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 5 mg/80 mg
Maltese: Arrow Génériques amlodipine / valsartan Arrow amlodipina / valsartan
English: Hydroxyzine ARROW hydroxyzine
Maltese: Hydroxyzine ARROW
English: Aurobindo Pharma Ltd, Malta
Maltese: Il-Finlandja Aurobindo Pharma Ltd,
English: Memantin Pharmascope 10 mg Filmtabletten memantine
Maltese: Memantin Pharmascope 10 mg Filmtabletten memantina
English: Memantin Pharmascope 20 mg Filmtabletten memantine
Maltese: Memantin Pharmascope 20 mg Filmtabletten memantina
English: Betahistine Sandoz 24 mg, tabletten
Maltese: Betahistine Sandoz 24 mg, tabletten betahistina
English: Betahistine Sandoz 16 mg, tabletten
Maltese: Betahistine Sandoz 16 mg, tabletten betahistina
English: Paracetamol 500mg Tablets paracetamol
Maltese: Paracetamol 500 mg Pilloli paraċetamol
English: Tablet
Maltese: MG TABLETY
English: Memantine Pharmascope 10 mg filmomhulde tabletten memantine
Maltese: Memantine Pharmascope 10 mg filmomhulde tabletten memantina
English: Aripiprazole 15 mg tablets aripiprazole
Maltese: Aripiprazole 15 mg pilloli aripiprażol
English: Memantine Pharmascope 20 mg filmomhulde tabletten memantine
Maltese: Memantine Pharmascope 20 mg filmomhulde tabletten memantina
English: Betahistine Sandoz 8 mg, tabletten
Maltese: Betahistine Sandoz 8 mg, tabletten betahistina
English: Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů ethinylestradiol / levonorgestrel
Maltese: 125 mikrogramů/30 mikrogramů etinilestradjol / levonorgestrel
English: Betahistine Sandoz 24 mg betahistine
Maltese: Betahistine Sandoz 24 mg
English: Betahistin Sandoz 16 mg betahistine
Maltese: Betahistin Sandoz 16 mg
English: Betahistin Sandoz 24 mg tablete
Maltese: Betahistin Sandoz 24 mg tablete betahistina
English: Tadalafil Milpharm 5 mg filmcoated tablets
Maltese: Tadalafil Milpharm 5 mg film-coated tablets
English: Betahistin Sandoz 16 mg tablete
Maltese: Betahistin Sandoz 16 mg tablete betahistina
English: Betahistin Sandoz 8 mg betahistine
Maltese: BETAHISTIN SANDOZ 8 MG
English: Betahistin Sandoz 8 mg tablete
Maltese: Betahistin Sandoz 8 mg tablete betahistina
English: Aurovitas Spain Voriconazol Aurovitas 50 mg comprimidos recubiertos con película EFG
Maltese: Voriconazol Aurovitas 50 mg comprimidos recubiertos con película EFG
English: Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipine / valsartan 5 mg /80 mg
Maltese: Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipina / valsartan
English: Betahistin Sandoz 24 mg tabletes
Maltese: Betahistin Sandoz 24 mg tabletes betahistina
English: Olanzapin HEC Pharm 20 mg Schmelztabletten olanzapin
Maltese: Olanzapin HEC Pharm 20 mg Schmelztabletten olanżapin
English: Betahistin Sandoz 8 mg tabletes
Maltese: Betahistin Sandoz 8 mg tabletes betahistina
English: Betahistin Sandoz 16 mg tabletes
Maltese: Betahistin Sandoz 16 mg tabletes betahistina
English: Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /80 mg
Maltese: Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipina / valsartan
English: Betahistin Sandoz 24 mg betahistine
Maltese: Betahistin Sandoz 24 mg
English: voriconazol
Maltese: vorikonażol
English: Olanzapin HEC Pharm 10 mg Schmelztabletten olanzapin
Maltese: Olanzapin HEC Pharm 10 mg Schmelztabletten olanżapin
English: Metformina Almus metformin hydrochloride
Maltese: Metformina Almus klorur tal-metformina 500 mg
English: Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipine / valsartan 10 mg /160 mg
Maltese: Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipina / valsartan
English: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 4 mg / 1.25 mg
Maltese: ZYDUS Franza perindopril/Indapamide Zydus Franza perindopril/indapami d
English: Olanzapin HEC Pharm 15 mg Schmelztabletten olanzapin
Maltese: Olanzapin HEC Pharm 15 mg Schmelztabletten olanżapin
English: Olanzapin HEC Pharm 5 mg Schmelztabletten olanzapin
Maltese: Olanzapin HEC Pharm 5 mg Schmelztabletten olanżapin
English: Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipine / valsartan 10 mg/160 mg
Maltese: Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipina / valsartan
English: United Kingdom Lupin (Europe) Limited
Maltese: Ir-Renju Unit Lupin (l-Ewropa) Limited
English: Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /160 mg
Maltese: Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipina / valsartan
English: Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipine / valsartan 5 mg /160 mg
Maltese: Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipina / valsartan
English: 2care4 Generics ApS
Maltese: Generics ApS
English: Metformin 850 mg Film-coated tablet metformin hydrochloride
Maltese: Metformin 850 mg Pillola miksija b'rita klorur tal-metformina 850 mg
English: Metformine Almus metformin hydrochloride
Maltese: Metformine Almus klorur tal-metformina 500 mg
English: Maexeni 150/30 microgram Film Coated Tablets ethinylestradiol / levonorgestrel
Maltese: Maexeni 150/30 mikrogramma Pilloli Miksijin b'Rita etinilestradjol / levonorgestrel
English: Amlodipina + Valsartan Aurovitas amlodipine / valsartan 5 mg /80 mg
Maltese: Amlodipine + Valsartan Aurovitas amlodipina / valsartan
English: Finland
Maltese: Malta
English: metformin hydrochloride
Maltese: MG betahistina diidroklorur
English: United Kingdom
Maltese: ΑΝΩΝΥΜΗ
English: 0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled syringes with needle safety device (multipack)
Maltese: 6 (3 x2) siringi mimlijin għal-lest b'apparat ta' sigurtà għal-labra (pakkett multiplu)
English: 0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled pens (multipack)
Maltese: 6 (3 x2) pinen mimlijin għal-lest (pakkett multiplu)
English: 0.8 ml (40 mg/0.8ml) 2 pre-filled pens
Maltese: 2 pinen mimlijin għal-lest
English: 0.8 ml (40 mg/0.8ml) 1 pre-filled pen
Maltese: pinna 1 mimlija għal-lest
English: EMA/34577/2014 Rev.1 EMEA/H/A-30/1302
Maltese: Rev.1 EMEA/H/A-30/1302
English: Rocephin is a medicine that contains the active substance ceftriaxone.
Maltese: Rocephin huwa mediċina li fiha s-sustanza attiva ceftriaxone.
English: Rocephin is marketed in the following EU Member States: Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Luxembourg, Malta, the Netherlands, Portugal, Romania, Sweden and the United Kingdom, as well as Iceland.
Maltese: Rocephin jiġi kkumerċjalizzat fl-Istati Membri tal-UE li ġejjin: il-Belġju, id-Danimarka, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Latvija, il-Lussemburgu, Malta, il-Pajjiżi lBaxxi, il-Portugall, ir-Rumanija, l-Isvezja u r-Renju Unit, kif ukoll l-Islanda.
English: What is Rocephin?
Maltese: X'inhu Rocephin?
English: The CHMP also harmonised other sections of the SmPC including section 4.3 (contraindications), 4.4 (special warnings and precautions for use) and 4.6 (pregnancy and lactation).
Maltese: Is-CHMP armonizza sezzjonijiet oħra tal-SmPC inkluż is-sezzjoni 4.3 (kontraindikazzjonijet), 4.4 (twissijiet speċjali u prekawzjonijiet għall-użu) u 4.6 (tqala u treddigħ).
English: Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion)
Maltese: (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, trab għal soluzzjoni għall-injezzjoni jew għal infużjoni).
English: It is also available in the EU under other trade names: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.
Maltese: Huwa disponibbli wkoll fl-UE taħt ismijiet kummerċjali oħrajn: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.
English: The areas harmonised include:
Maltese: L-oqsma armonizzati jinkludu:
English: What are the conclusions of the CHMP?
Maltese: X'inhuma il-konklużjonijiet tal-CHMP?
English: • complicated urinary tract infections, including pyelonephritis (kidney infection);
Maltese: • infezzjonijiet tal-apparat tal-awrina (UTI), inkluż pajelonefrite (infezzjoni fil-kliewi);
English: On 23 January 2014, the European Medicines Agency completed a review of Rocephin.
Maltese: Fit-23 ta' Jannar 2014, l-Aġenzija Ewropea tal-Mediċina temmet reviżjoni ta' Rocephin.
English: Rocephin may be used to treat acute exacerbations (flare-ups) of chronic obstructive pulmonary disease in adults.
Maltese: Rocephin jista' jintuża biex jikkura taħrix akut (flare-ups) tal-marda pulmonari ostruttiva kronika f'adulti.
English: Rocephin is authorised in the EU via national procedures.
Maltese: Rocephin huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: • acute otitis media (infection of the middle ear);
Maltese: • otite medja akuta (infezzjoni fil-widna tan-nofs);
English: Rocephin should preferably be given into a vein by injection over a period of 5 minutes or by infusion (drip) over at least 30 minutes, or else by deep intramuscular injection.
Maltese: Rocephin preferibbilment għandu jingħata fil-vina b'injezzjoni fuq perjodu ta' 5 minuti jew b'infużjoni (dripp) fuq mill-inqas 30 minuta, jew inkella b'injezzjoni fil-fond ġo muskolu.
English: • the sexually transmitted infections gonorrhoea and syphilis;
Maltese: • l-infezzjonijiet trasmessi sesswalment, gonorrea u sifilise;
English: • bacterial endocarditis (an infection in the heart).
Maltese: • endokardite batterika (infezzjoni fil-qalb).
English: • bacterial meningitis;
Maltese: • meninġite batterika;
English: Rocephin may be used to manage patients with neutropenia (low levels of neutrophils, a type of white blood cell) who also have fever suspected to be caused by bacterial infection, patients with bacteraemia (when the bacteria are detected in the blood) suspected to be caused by any of the infections mentioned above, and for the pre-operative prevention of surgical site infections.
Maltese: Rocephin jista' jintuża sabiex jimmaniġġja pazjenti b'newtropenja (livelli baxxi ta' newtrofili, tipi ta' ċelloli bojod tad-demm) li jkollhom ukoll deni suspettat li jkun ikkawżat minn infezzjoni batterjali, pazjenti b'batterimija (meta l-batterji jiġu rilevati fid-demm) suspettata li hija kkawżata b'xi infezzjoni imsemmija fuq, u għal prevenzjoni qabel l-operazzjoni ta' infezzjonijiet fis-sit tal-kirurġija.
English: Rocephin was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Rocephin ġie identifikat bħala li għandu bżonn armonizzazzjoni mill-Grupp ta' Koordinazzjoni għarRikonoxximent Reċiproku u Proċeduri Deċentralizzati - Bniedem (CMDh).
English: The CHMP agreed that Rocephin should no longer be used to treat sinusitis (inflammation of the sinuses), pharyngitis (sore throat) and prostatitis (inflammation of the prostate, a gland of the male reproductive system) because not enough clinical data are available to support these indications.
Maltese: Is-CHMP qabel li Rocephin ma għandux jintuża iktar biex jikkura s-sinusite (infjammazzjoni tas-sinus), il-farinġite (uġigħ fil-griżmejn) u l-prostatite (inflammazzjoni tal-prostata, glandola tas-sistema riproduttiva maskili) għax m'hemmx biżżejjed dejta klinika li tappoġġja dawn l-indikazzjonijiet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Rocephin in the European Union (EU).
Maltese: Il-Kumitat taltal-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ikkonkluda li hemm bżonn li ssir armonizzazzjoni tal-informazzjoni tal-preskrizzjoni għal Rocephin fl-Unjoni Ewropea (UE).
English: • intra-abdominal infections (infections within the abdomen);
Maltese: • infezzjonijiet intra-addominali (infezzjoni fi ħdan l-addome);
English: Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Rocephin in adults and children.
Maltese: Wara li armonizza l-indikazzjonijiet, is-CHMP armonizza wkoll ir-rakomandazzjonijiet ta' kif għandu jintuża Rocephin f'adulti u tfal.
English: In adults and children over 12 years of age, the recommended dose varies between 1 and 4 g of Rocephin once daily depending on the condition it is used to treat.
Maltese: Fl-adulti u fit-tfal ta' aktar minn 12-il sena, id-doża rakkomandata tvarja bejn 1 u 4 g ta' Rocephin waħda kuljum, jiddependi fuq il-kundizzjoni li għaliha jkun intuża biex jikkura.
English: 4.2 Posology and method of administration
Maltese: 4.2 Pożoloġija u metodu ta' kif għandu jingħata
English: It is an antibiotic used to treat a wide range of bacterial infections including pneumonia (infection of the lungs) and meningitis (infection of the membranes around the brain and spine).
Maltese: Dan huwa aġent antibijotiku użat biex jikkuraw firxa wiesgħa ta' infezzjoniet antibatteriċi inklużi pulmonite (infezzjoni fil-pulmun) u meninġite (infezzjoni fil-membrani madwar il-moħħ u s-sinsla).
English: Ceftriaxone belongs to the group ‘cephalosporins'; it works by attaching to proteins on the surface of bacteria.
Maltese: Ceftriaxone jappartjeni għall-grupp ‘cephalosporins'; jaħdem billi jeħel mal-proteini fuq il-wiċċ tal-batterji.
English: On 9 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Rocephin in the EU.
Maltese: Fid-9 ta' Diċembru 2011, il-Kumissjoni Ewropea irriferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzajoni għat-tqegħid fis-suq ta' Rocephin fl-UE.
English: It may also be used to treat disseminated Lyme borreliosis (a bacterial infection spread to humans by infected ticks) in adults and children including neonates from 15 days of age.
Maltese: Jista' jintuża wkoll biex jikkura Lyme borreliosis imxerrda (infezzjoni batterjali li tinfirex għallbniedem minn qurdien infettat) fl-adulti u tfal inkluż trabi tat-twelid li għandhom minn 15 il-ġurnata ‘l fuq.
English: Why was Rocephin reviewed?
Maltese: Għaliex ġie rivedut Rocephin?
English: The CHMP concluded that Rocephin should be used to treat the following infections in adults and children, which were already approved in several but not all EU Member States:
Maltese: Is-CHMP ikkonkluda li Rocephin għandu jintuża biex jikkura l-infezzjonijiet li ġejjin fl-adulti u fit-tfal, li kienu diġà approvati f'ħafna imma mhux fl-Istati Membri tal-UE kollha:
English: 1 dose 5 x 1 dose 10 x 1 dose
Maltese: 5 x 1 doża 10 x 1 doża
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti
English: Active substances:
Maltese: Sustanza Attiva :
English: Cholesterol
Maltese: Kolesterol
English: 1 dose
Maltese: 1 doża
English: 62.5 micrograms
Maltese: 62.5 mikrogrammi
English: 375 micrograms
Maltese: 375 mikrogrammi
English: 125 micrograms
Maltese: 125 mikrogrammi
English: Tetanus toxoid
Maltese: Tetanus Toksojd
English: Phosphate buffer, traces of thiomersal, traces of formaldehyde
Maltese: Buffer tal-fosfat, tracci ta' tajomersal, traċċi ta formalina.
English: A/equine-2/ South Africa/4/03 (50 AU), A/equine-2/Newmarket/2/93 (50 AU), Tetanus toxoid 40 Lf.
Maltese: Doża ta 1 ml: A/equine-2/ South Africa/4/03 (50 AU), A/equine-2/Newmarket/2/93 (50 AU), Tetanus toksojd 40 Lf.
English: C/Zeppelin 6, Parcela 38 37008 Carbajosa de la Sagrada Salamanca
Maltese: 37008 Carbajosa de la Sagrada
English: Prequenza Prequenza
Maltese: Prequenza Prequenza Prequenza
English: 4.3 Contraindications None
Maltese: 4.3 Kontra indikazzjonijiet
English: Onset of immunity:
Maltese: Bidu tal-immunita:
English: 1 Antigenic units
Maltese: 1 Partijiet antiġeniċi
English: NL-5831 AN Boxmeer
Maltese: Wim de Körverstraat 35 NL-5831 AN Boxmeer Olanda
English: CONTRAINDICATIONS
Maltese: Indikazzjonijiet
English: V1 V2
Maltese: T1 T2 5
English: i.m.
Maltese: A.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/057/001-004
Maltese: EU/2/05/057/001-004
English: 1 ml.
Maltese: Doża kull 1 ml
English: Tetanus
Maltese: Tetnu
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 (inklus l-adġuvanti) msemmija f'sezzjoni 6.1 tal- KPQ huma, jew sustanzi permessi li tabella 1 tal-anness tar-Regoli tal-Kummissjoni (EU) No 37/2010 tindika li l-ebda MRLs huma meħtieġa jew kunsidrati li ma jaqawx fl-iskop tar-Regolamenti (EC) No 470/2009 meta użati bħall f'dan il-prodott mediċinali veterinarju.
English: Prequenza Prequenza Te
Maltese: Equilis Prequenza Te
English: Concurrent active and passive immunisation (emergency vaccination)
Maltese: Immunita attiva u passiva f daqqa (tilqima ta' emerġenza)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza Te
Maltese: VETERINARJU Equilis Prequenza Tegstampa ċara ta'żiemelħ
English: Equine influenza virus strains:
Maltese: Strejn tal-virus tal-influenza taż-żwiemel
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 08 July 2005 / 27 July 2010
Maltese: 08 ta' Lulju 2005/ 27 ta' Lulju 2010
English: 5831 AN Boxmeer
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer Olanda
English: Adjuvants: Purified Saponin
Maltese: Sustanzi mhux attivi Saponin purifikat
English: Phosphatidylcholine
Maltese: KWALITAJIET FARMAKOLOĠIĊI
English: Influenza
Maltese: Influwenza
English: METHOD AND ROUTE OF ADMINISTRATION
Maltese: U METODU TA' AMMINISTRAZZJONI
English: 62.5 micrograms For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' l-ingredjenti mhux attivi, ara s-sezzjoni 6.1.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI
English: use
Maltese: AU
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (Primary vaccination course at 6 months of age and 4 weeks later)
Maltese: F' kas ta' riskju akbar ta' infezzjoni jew nuqqas ta' teħid ta' kolostrum, tilqima addizjonali tista' tingħata fir-raba' xahar segwita bil programm komplut ta' vaċċinazzjoni (l-ewwel kors ta' tilqim ta' 6 xhur u doża ohra 4 ġimgħat wara).
English: Horses
Maltese: VETERINARJU
English: TARGET SPECIES Horses
Maltese: Kodici ATĊ veterinarja:
English: Concurrent use of Equilis Prequenza Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Prequenza Te in the absence of tetanus antitoxin serum.
Maltese: L- użu flimkien ta' Equilis Prequenza Te u Tetanus-Serum tal-Intervet jista' jnaqqas l-immunita attiva kontra t-tetnu meta mqabbla ma żwiemel oħra mlaqqma bl- Equilis Prequenza Te biss (mingħajr l-antitoksin tas-sirum tat-tetnu).
English: Store at 2-8 °C, protected from light.
Maltese: Aħżen fil-friġġ (2°C - 8°C ), Ipproteġi mid-dawl.
English: SPECIAL WARNING(S)
Maltese: MANIFATTUR(I)
English: The second revaccination is given 12 months after the first revaccination.
Maltese: It- tieni rivaċċinazzjoni tingħata wara 12-il xahar mill-ewwel rivaċċinazzjoni .
English: Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur.
Maltese: Qies ta' ekwivalenti ta' flokulazzjoni; jikkorispondu ma ≥30IU/ml sirum tal-fenek tal-Indi fit-test ta' potenza tal-Farmakopeja Ewropeja.
English: Cardboard box with 10 glass vials of 1 ml.
Maltese: Kaxxa tal- kartun b 10 fjali tal-ħ[ie[ ta 1 ml.
English: In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate injection site, using separate syringes and needles.
Maltese: F dak il-kas, l-ewwel doża (T1) tal-vaċċin tista tingħata flimkien mad-doża profilattika adatta ta' Tetanus-Serum tal-Intervet iżda f' post tal-injezzjoni differenti u b'labar u siringi differenti.
English: Spain
Maltese: Salamanca Spanja
English: IMMUNOLOGICAL PROPERTIES
Maltese: IMMUNOLOĠIĊI
English: The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.
Maltese: Iċ-ċiklu tar-rapport perjodiku aġġornat tas-sigurtaċ (PSUR) għandu jerġa jinbeda kull 6 xhur għallsottomissjoni tar-rapporti (li jkopru kull preżentazzjoni awtorizzata tal-prodott) għall-sentejn, segwit b'rapporti annwali għas-sentejn sussegwenti u wara f'perjodi ta'3 snin.
English: Adjuvant Purified saponin
Maltese: PARIR SABIEX
English: PHARMACEUTICAL FORM Clear opalescent suspension for injection
Maltese: Suspensjoni għall-injezzjoni
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet (see section 4.9).
Maltese: L-informazzjoni dwar is-sigurtà u l-effikaċja ta' dan il-vaċċin turi li jista jiġi amministrat fl-istess ġurnata li jinghata is-Serum tat-Tetnu tal-Intervet , imma mhux imħallat mieghu, (ara sezzjoni 4.9
English: To stimulate active immunity against Equine influenza and tetanus ATC-vet code: QI05AL01
Maltese: B' din it-tilqima l-immunita kontra l- influwenza taż-zwiemel iddum talanqas għal 12-il xahar.
English: For animal treatment only - to be supplied only on veterinary prescription.
Maltese: Tħallatx ma l-ebda prodott mediċinali veterinarju ieħor.
English: Read package leaflet before use.
Maltese: Mhux id-daqs tal-pakketti kollha jistgħu qegħdin fis-suq.
English: INDICATION(S) Active immunisation of horses against equine influenza and tetanus
Maltese: Biex tistimula immunita attiva kontra l-influwenza taż-zwiemel u t-tetnu.
English: The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/equine-2/South Africa/4/03and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme).
Maltese: Kull 12 -il xahar huwa rakkomandat li tingħata tilqima addattata kontra l-influwenza taż-żwiemel, li jkollha dawn l-istrejns A/equi 1/Prague 56, A/equi 2/Newmarket-1/93 u A/equi 2/Newmarket-2/93,
English: 4.2 Indications for use, specifying the target species Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection, and active immunisation against tetanus to prevent mortality.
Maltese: Immunizzazzjoni attiva għal żwiemel minn sitt xhur il-fuq, kontra l-influwenza taż-żwiemel, biex tnaqqas is-sintomi kliniċi u l-eskrezzjoni tal- virus wara l-infezzjoni, u immunizzazzjoni kontra t-tetnu biex tipprevjeni l-imwiet.
English: GSK Vaccines GmbH
Maltese: Isem u indirizz tal-manufattur tas-sustanzi bioloġika(ċi) attiva(i) GSK Vaccines GmbH
English: Package size:
Maltese: Daqs tal-pakketti:
English: Name and address of the manufacturer of the biological active substance(s)
Maltese: TAS-SUSTANZA(I) BIOLOĠIKA(/BIOLOĠIĊI)