FrancophonIA/ELRC3.0 huggingface dataset:
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients
Maltese: PTPs = pazjenti kkurati qabel, PUPs (previously untreated patients) = pazjenti li ma ġewx ittrattati filpassat
English: Helixate NexGen contains sodium
Maltese: Helixate NexGen fih is-sodium
English: Detailed instructions for reconstitution and administration of Helixate NexGen using the Mix2Vial adapter:
Maltese: Istruzzjonijiet dettaljati għar-rikostituzzjoni u l-għoti ta' Helixate NexGen bl-użu tal-adattatur Mix2Vial:
English: Additional pharmacokinetic parameters for Helixate NexGen for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 mL/h.Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 mL/h corresponding to 3.0 mL/h/kg (range 1.6-4.6 mL/h/kg).
Maltese: Aktar parametri farmakokinetiċi ta' Helixate NexGen għall-injezzjoni bolus huma: żmien medju residenzjali [MRT (0-48)] ta' madwar 22 siegħa, u tneħħija ta' madwar 160 mL/siegħa.
English: • one vial with solvent (6 mL clear glass type 1 vial with latex-free grey chlorobutyl rubber blend stopper and aluminium seal)
Maltese: • kunjett wieħed bis-solvent (kunjett ta' 6 ml tal-ħġieġ trasparenti tip 1 b'tapp griż magħmul minn taħlita ta' gomma chlorobutyl li ma fihx latex u siġill tal-aluminju).
English: Helixate NexGen 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution.
Maltese: IU fih (250 IU / 2.5 mL) = 100 IU octocog alfa f'kull mL wara r-rikostituzzjoni.
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Maltese: Tiffiltra billi tuża l-adattatur Mix2Vial.
English: Usually, the substitution therapy with Helixate NexGen is a life-time treatment.
Maltese: Ġeneralment, it-terapija ta' sostituzzjoni b'Helixate NexGen hija trattament tul il-ħajja kollha.
English: No interactions of Helixate NexGen with other medicinal products have been reported.
Maltese: Ma ġiet irrappurtata l-ebda interazzjoni ta' Helixate NexGen ma' prodotti mediċinali oħra.
English: Other medicines and Helixate NexGen
Maltese: Mediċini oħra u Helixate NexGen
English: No studies were performed on the mutagenic potential of Helixate NexGen, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of Helixate NexGen.
Maltese: Ma sarux studji dwar il-potenzjal mutaġeniku ta' Helixate NexGen peress li ma seta jiġi osservat lebda potenzjal mutaġeniku in vitro jew in vivo għall-prodott predeċessur ta' Helixate NexGen.
English: However, during in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in PVC bags for continuous infusion".
Maltese: Madankollu, waqt studji in vitro, l-istabbilità kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 30°C f'boroż tal-PVC għall-infużjoni kontinwa.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 August 2000
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 04 ta' Awwissu 2000
English: • one vial with powder (10 mL clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal)
Maltese: • kunjett wieħed bit-trab (kunjett ta' 10 mL tal-ħġieġ trasparenti tip 1 b'tapp griż magħmul minn taħlita ta' gomma halogenobutyl li ma fihx latex u siġill tal-aluminju).
English: How to store Helixate NexGen Contents of the pack and other information
Maltese: Kif jidher Helixate NexGen u l-kontenut tal-pakkett
English: • One mL Helixate NexGen 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Maltese: IU fih madwar 100 IU (250 IU / 2.5 mL) ta' fattur VIII rikombinanti tal-koagulazzjoni umana (INN: octocog alfa) wara r-rikostituzzjoni b'ilma għallinjezzjonijiet.
English: Expected factor VIII rise (% of normal) = 2 × administered IU
Maltese: II. Żieda mistennija ta' fattur VIII (% tan-normal)= 2 × IU mogħtija piż tal-ġisem (kg)
English: How to store Helixate NexGen
Maltese: Tużax Helixate NexGen
English: • One mL Helixate NexGen 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Maltese: IU fih madwar 400 IU (1000 IU / 2.5 mL) ta' fattur VIII rikombinanti tal-koagulazzjoni umana (INN: octocog alfa) wara r-rikostituzzjoni b'ilma għallinjezzjonijiet.
English: • an additional package with: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 mL syringe - 2 alcohol swabs for single use
Maltese: [Mix2Vial] - sett biex ittaqqab il-vina - siringa ta' 5 ml li tintrema wara li tintuża - 2 imsielaħ bl-alkoħol biex jintużaw darba.
English: Helixate NexGen 250 IU powder and solvent for solution for injection Helixate NexGen 500 IU powder and solvent for solution for injection Helixate NexGen 1000 IU powder and solvent for solution for injection Helixate NexGen 2000 IU powder and solvent for solution for injection Helixate NexGen 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Helixate NexGen 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni Fattur VIII rikombinanti tal-koagulazzjoni (octocog alfa)
English: After administration of Helixate NexGen, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours.
Maltese: Wara l-għoti ta' Helixate NexGen, l-ogħla attività tal-fattur VIII naqset permezz ta' degradazzjoni esponenzjali f'żewġ fażijiet b'half-life terminali medja ta' madwar 15-il siegħa.
English: Helixate NexGen is used for treatment and prophylaxis of bleeding adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).
Maltese: Helixate NexGen jintuża għat-trattament u l-profilassi ta' fsada f'adulti, adolexxenti u tfal ta' kull età li għandhom l-emofilja A (nuqqas konġenitali tal-fattur VIII).
English: • the severity of your haemophilia
Maltese: • is-severità tal-emofilja tiegħek
English: Warm both unopened vials in your hands to a comfortable temperature (do not exceed 37 °C).
Maltese: Saħħan iż-żewġ kunjetti magħluqa f'idejk sakemm dawn jilħqu temperatura komda (taqbizx 37 °C).
English: Helixate NexGen 2000 IU contains (2000 IU / 5 mL) = 400 IU octocog alfa per mL after reconstitution.
Maltese: IU / 5 mL) = 400 IU octocog alfa f'kull mL wara rrikostituzzjoni.
English: Haemophilia.
Maltese: Tħawwadx.
English: Helixate NexGen 250 IU powder for solution for injection Helixate NexGen 500 IU powder for solution for injection Helixate NexGen 1000 IU powder for solution for injection Helixate NexGen 2000 IU powder for solution for injection Helixate NexGen 3000 IU powder for solution for injection
Maltese: Il-grupp qabel ukoll li dejta speċifika dwar il-frekwenza tal-inibituri għal kull prodott għandha tiġi inkluża fl-SmPC peress li l-istudji disponibbli mhumiex fornuti b'mod adegwat biex joħorġu konklużjonijiet preċiżi dwar il-frekwenza assoluta għal kull prodott jew dwar il-frekwenza relattiva tal-inibituri bejn il-prodotti.
English: It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that Helixate NexGen can be used for continuous infusion in surgeries (pre-, during and postoperative).
Maltese: Fi studju kliniku li twettaq fuq pazjenti adulti b'emofilja A li kellhom operazzjoni maġġuri, intwera li Helixate NexGen jista' jintuża għall-infużjoni kontinwa fl-operazzjonijiet (qabel, matul u wara loperazzjoni).
English: Eligible
Maltese: Maġġuri
English: EMA/439864/2014 EMEA/H/C/00165
Maltese: EMEA/H/C/00165
English: The full EPAR for Enyglid 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: Enyglid is a ‘generic medicine'.
Maltese: Enyglid huwa ‘mediċina ġenerika'.
English: It is available as tablets (0.5, 1 and 2 mg).
Maltese: Jiġi f'għamla ta' pilloli (0.5, 1 u 2 mg).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dijabete tat-tip 2 li l-livelli ta' glukożju fid-demm tagħhom is-soltu jiġu kkontrollati sew b'dieta, iżda li qegħdin jitilfu kontroll tal-glukożju fid-demm għal perjodu temporanju.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Enyglid on 14 October 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Enyglid valida fl-Unjoni Ewropea kollha fl-14 ta' Ottubru 2009.
English: Enyglid is a diabetes medicine that contains the active substance repaglinide.
Maltese: Enyglid huwa mediċina tad-dijabete li fiha s-sustanza attiva repaglinide.
English: Enyglid is taken before meals, normally up to 15 minutes before each main meal.
Maltese: Enyglid jingħata qabel l-ikliet, is-soltu mhux aktar minn 15-il minuta qabel kull ikla prinċipali.
English: This is a summary of the European public assessment report (EPAR) for Enyglid.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Enyglid.
English: This means that Enyglid is similar to a ‘reference medicine' already authorised in the European Union (EU) called NovoNorm.
Maltese: Dan ifisser li Enyglid huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem NovoNorm.
English: Because Enyglid is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, NovoNorm.
Maltese: Billi Enyglid huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, NovoNorm.
English: Why has Enyglid been approved?
Maltese: Għaliex ġie approvat Enyglid?
English: The CHMP concluded that, in accordance with EU requirements, Enyglid has been shown to have comparable quality and to be bioequivalent to NovoNorm.
Maltese: Is-CHMP ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Enyglid għandu kwalità komparabbli u li huwa bijoekwivalenti għal NovoNorm.
English: If patients are transferred from another diabetes medicine, the recommended starting dose is 1 mg.
Maltese: Jekk pazjenti jibdlu minn mediċina oħra tad-dijabete, id-doża tal-bidu rakkomandata hija 1 mg.
English: What is Enyglid?
Maltese: X'inhu Enyglid?
English: What are the benefits and risks of Enyglid?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Enyglid?
English: It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) is not adequately controlled by diet, weight reduction and exercise.
Maltese: Jintuża flimkien ma' dieta u eżerċizzju biex ibaxxi l-livelli ta' glukożju (zokkor) fid-demm f'pazjenti li jkollhom ipergliċemija (livelli għoljin ta' glukożju fid-demm) li ma tkunx tista' tiġi kkontrollata b'mod adegwat permezz ta' dieta, tnaqqis fil-piż u eżerċizzju.
English: How has Enyglid been studied?
Maltese: Kif ġie studjat Enyglid?
English: Enyglid helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Maltese: Enyglid jgħin lill-frixa tipproduċi iktar insulina f'ħin l-ikel u jintuża biex jikkontrolla d-dijabete tat-tip 2.
English: Enyglid may also be used with metformin (another diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Maltese: Enyglid jista' jintuża wkoll ma' metformin (mediċina oħra tad-dijabete) f'pazjenti biddijabete tat-tip 2 li jkollhom livelli ta' glukożju fid-demm li ma jkunux ikkontrollati biżżejjed bl-użu ta' metformin waħdu.
English: Because Enyglid is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Maltese: Minħabba li Enyglid huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċju u r-riskju tiegħu huma meqjusa li huma analogi għal dawk tal-mediċina ta' referenza.
English: Enyglid is used in adults who have type 2 diabetes.
Maltese: Enyglid jintuża f'adulti li għandhom id-dijabete tat-tip 2.
English: Therefore, the CHMP's view was that, as for NovoNorm, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' NovoNorm, il-benefiċċju huwa akbar mir-riskju identifikat.
English: EMEA/V/C/052
Maltese: EMEA/V/C/052 RAPPORT TAL-VALUTAZZJONI
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 46 E-mail: mail@emea.europa.eu http://www.emea.europa.eu EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 46 E-mail: mail@emea.europa.eu http://www.emea.europa.eu EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged prevalenza ta' razez reżistenti fl-ispeċi fil-mira għalkemm dan ir-riskju huwa mistenni li jkun inqas ta' tħassib minħabba t-trattament ta' annimali individwali b'dan il-prodott.
English: Ibaflin is available as tablets (30, 150, 300 and 900 mg) and as oral gels (3 and 7.5%).
Maltese: Ibaflin jiġi bħala pilloli (30, 150, 300 u 900 mg) u bħala ġellijiet li jittieħdu mill-ħalq (3 u
English: What is Ibaflin?
Maltese: Ibaflin?
English: The standard dose is 15 mg per kilogram body weight once a day for the length of time determined by your veterinarian.
Maltese: Id-doża standard hija 15 mg għal kull kilogramm tal-piż tal-ġisem darba kuljum għat-tul ta' żmien stabbilit mill-veterinarju tiegħek.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) IBAFLIN EPAR summary for the public
Maltese: PUBBLIKA EWROPEW (EPAR) IBAFLIN
English: The marketing authorisation was renewed on 13 June 2005.
Maltese: awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit-13 ta' Ġunju 2005.
English: • upper respiratory tract infections caused by Staphylococci, E. coli and Klebsiella species.
Maltese: • Infezzjonijiet fil-parti ta' fuq tal-passaġġ respiratorju ikkawżati mill-ispeċi Staphylococci, E. coli u Klebsiella.
English: Ibafloxacin, is an antibiotic belonging to the class ‘fluoroquinolones'.
Maltese: Ibafloxacin, huwa antibijotiku li jappartieni għall-klassi ta' ‘fluoroquinolones'.
English: • skin infections, including shallow and deep ‘pyoderma', infected wounds and abscesses caused by bacteria such as Staphylococci, E. coli, Proteus species and Pasteurella species,
Maltese: • Infezzjonijiet tal-ġilda, inkluż ‘pyoderma' fil-wiċċ u fonda, feriti infettati u axxesi kkawżati minn baterji bħall-ispeċi Staphylococci, E. coli, Proteuss u l-ispeċi Pasteurella,
English: Why has Ibaflin been approved?
Maltese: Għaliex ġie approvat Ibaflin?
English: Cats are treated using the 3% oral gel.
Maltese: Il-qtates huma ttrattati permezz ta' 3% ġel orali.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ibaflin to Intervet International B.V. on 13 June 2000.
Maltese: Ewropea kollha għal Ibaflin lil Intervet International B.V. fit-13 ta' Ġunju 2000.
English: These effects are mild and temporary.
Maltese: Dawn l-effetti huma ħfief u temporanji.
English: Other information about Ibaflin:
Maltese: Tagħrif ieħor dwar Ibaflin:
English: From data of two different clinical trials, comparable efficacy was shown between the Ibaflin gel formulations and a positive control to support the claims for skin (soft tissue infections - wounds, abscesses) and upper respiratory tract infections in cats for the oral gel formulations.
Maltese: Mit-tagħrif miġbur minn żewġ provi kliniċi differenti, intweriet effikaċja komparabbli bejn ilformulazzjonijiet tal-ġel ta' Ibaflin u kontroll pożittiv biex jiġu appoġġjati l-klejms għal infezzjonijiet tal-ġilda (infezzjonijiet tat-tessut artab - feriti, axxesi) u infezzjonijiet tal-parti ta' fuq tal-passaġġ respiratorju fi qtates għall-formolazzjonijiet tal-ġel orali.
English: It is also used in dogs to treat acute (short-lived), uncomplicated infections of the urinary tract caused by Staphylococci, Proteus species, Enterobacter species, E. coli and Klebsiella species.
Maltese: Jintuża wkoll fi klieb biex jittratta infezzjonijiet akuti (li jdumu qasir żmien), mhux ikkumplikati tal-passaġġ urinarju ikkawżati mill-ispeċi Staphylococci, l-ispeċi Proteus, l-ispeċi Enterobacter, E. coli u Klebsiella.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ibaflin exceed the risks for the treatment of skin infections, and respiratory tract infections (upper tract) in dogs and cats, and acute, uncomplicated urinary tract infections in dogs, and recommended that Ibaflin be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Ibaflin jisbqu r-riskji għat-trattament ta' infezzjonijiet tal-ġilda, u infezzjonijiet fil-passaġġ respiratorju (parti ta' fuq) fi klieb u qtates, u infezzjonijiet akuti mhux ikkumplikati fil-passaġġ urinarju, u rrakkomanda li Ibaflin jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: By blocking DNA gyrase, ibafloxacin prevents the bacteria from making DNA and stops them making proteins and growing, resulting in their death.
Maltese: Billi jimblokka DNA gyrase, ibafloxacin jimpedixxi l-batterji milli jagħmlu DNA u jwaqqafhom milli jagħmlu proteini u milli jikbru, u dan iwassal għall-mewt tagħhom.
English: How has Ibaflin been studied?
Maltese: Kif ġie studjat Ibaflin?
English: Ibaflin oral gel is indicated in dogs for the treatment of skin infections (pyoderma - superficial and deep, wounds, abscesses).
Maltese: Il-ġel orali Ibaflin huwa indikat sabiex jintuża fuq klieb għat-trattament ta' infezzjonijiet tal-ġilda (pyoderma - feriti fil-wiċċ u fondi,
English: For more information, see the Package Leaflet.
Maltese: Bil-ġel orali jista' jiġi osservat tbeżliq.
English: A strain which is resistant to one type of fluoroquinolone will also be resistant to other members of the class of fluoroquinolones.
Maltese: Razza li hija reżistenti għal tip ta' fluoroquinolone tkun reżistenti wkoll għal membri oħrajn tal-klassi ta' fluoroquinolones.
English: EMEA 2007
Maltese: Kif jaħdem
English: Diarrhoea, soft faeces, vomiting, dullness (lack of responsiveness) and anorexia (loss of appetite) occur with low frequency in dogs and cats given Ibaflin.
Maltese: Dijarrea, ippurgar maħlul, rimettar, nuqqas ta' rispons u anoreksja (nuqqas ta' aptit) iseħħu bi frekwenza baxxa fi klieb u qtates mogħtija Ibaflin.
English: The tablets and oral gel were of comparable effectiveness in treating skin infections in dogs.
Maltese: Il-pilloli u l-ġel orali kienu ta' effettività komparabbli fit-trattament ta' infezzjonijiet tal-ġilda fil-klieb.
English: People who are hypersensitive (allergic) to quinolones should avoid any contact with Ibaflin.
Maltese: Nies li huma sensittivi żżejjed (allerġiċi) għal quinolones għandhom jevitaw kwalunkwe kuntatt ma' Ibaflin.
English: How does Ibaflin work?
Maltese: X'inhu Ibaflin?
English: Ibaflin contains ibafloxacin, which belongs to a class of medicines having an antibiotic action.
Maltese: Ibaflin fih ibafloxacin, li jappartieni għal klassi ta' mediċini li għandhom azzjoni antibijotika.
English: The indication for treatment of urinary infections in cats was not accepted.
Maltese: L-indikazzjoni għat-trattament ta' l-infezzjonijiet urinarji fi qtates ma ġietx aċċettata.
English: The oral gel has been studied in cats looking at skin, respiratory tract and urinary tract infections.
Maltese: Il-ġel orali ġie studjat fuq il-qtates billi ġew osservati infezzjonijiet tal-ġilda, tal-passaġġ respiratorju u tal-passaġġ urinarju.
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport tal-Valutazzjoni Pubblika Ewropew..
English: It works by blocking an enzyme called ‘DNA gyrase', which is important in allowing bacteria to make copies of their DNA.
Maltese: Jaħdem billi jimblokka enzim imsejjaħ ‘DNA gyrase', li huwa importanti sabiex il-batterji jitħallew jagħmlu kopji tad-DNA tagħhom.
English: This summary was last updated in November 2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Novembru 2018.
English: Further information can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/aftovaxpur-doe.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/aftovaxpur-doe.
English: These strains belong to four different serotypes (groups) of the virus known as O, A, Asia 1 and SAT2, and are selected, depending on the epidemiological need, from the following eight strains: O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir and SAT2 Saudi Arabia.
Maltese: Dawn ir-razez jagħmlu parti minn erba' serotipi (gruppi) differenti tal-virus magħrufa bħala O, A, Asia 1 u SAT2, u jintgħażlu, skont il-ħtieġa epidemjoloġika, mit-tmien razez li ġejjin: O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir u SAT2 Saudi Arabia.
English: Other information about Aftovaxpur DOE
Maltese: Informazzjoni oħra dwar Aftovaxpur DOE
English: Sufficient justification for extrapolation of these data to other strains was provided.
Maltese: Kienet ipprovduta ġustifikazzjoni suffiċjenti għall-estrapolazzjoni ta' din id-data għal razez oħra.
English: A slight increase in rectal temperature, of up to 1.2 °C for 4 days, may affect up to 1 in 10 animals following vaccination.
Maltese: Żieda żgħira fit-temperatura tar-rektum, ta' massimu ta' 1.2 °C għal 4 ijiem, tista' taffettwa sa 1 minn kull 10 annimali wara t-tilqima.
English: Aftovaxpur DOE is a vaccine.
Maltese: Aftovaxpur DOE huwa vaċċin.
English: The range of antibodies produced following vaccination with Aftovaxpur DOE was different from that produced by natural infection; this makes it possible to distinguish vaccinated from infected animals, which is important for disease control.
Maltese: Il-firxa ta' antikorpi prodotti wara t-tilqim b'Aftovaxpur DOE kienet differenti minn dik prodotta minn infezzjoni naturali; dan jagħmilha possibbli li ssir distinzjoni bejn annimali mlaqqma u annimali infettati, li huwa importanti għall-kontroll tal-marda.
English: Aftovaxpur DOE received a marketing authorisation valid throughout the EU on 15 July 2013.
Maltese: Aftovaxpur DOE ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-15 ta' Lulju 2013.
English: What are the risks associated with Aftovaxpur DOE?
Maltese: X'inhuma r-riskji assoċjati ma' Aftovaxpur DOE?
English: Aftovaxpur DOE contains an adjuvant (liquid paraffin) to enhance the immune response.
Maltese: Aftovaxpur DOE fih aġġuvant (paraffin likwidu) biex itejjeb ir-rispons immunitarju.
English: Aftovaxpur DOE (Foot-and-mouth disease vaccine, killed)
Maltese: Aftovaxpur DOE (vaċċin kontra l-marda tal-ilsien u ddwiefer, maqtula)
English: Swellings (up to 12 cm diameter in ruminants and 4 cm in pigs) at the injection site occur in most animals after vaccination.
Maltese: Wara t-tilqim il-biċċa l-kbira tal-annimali jkollhom nefħa (dijametru sa 12 cm f'ruminanti u 4 cm filħnieżer) fis-sit tal-injezzjoni.
English: If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Maltese: Jekk l-uġigħ jippersisti għal aktar minn 12il siegħa wara l-eżami mediku, it-tabib għandu jerġa' jiġi kkuntattjat.
English: Vaccine containing O1 Manisa antigen reduces clinical signs of foot-and-mouth disease in cattle, sheep and pigs.
Maltese: Il-vaċċin li fih l-antiġen O1 Manisa jnaqqas is-sinjali kliniċi tal-marda tal-ilsien u d-dwiefer fil-frat, fin-nagħaġ u fil-ħnieżer.