FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rare (may affect up to 1 in 10,000 people):
Maltese: Rari ħafna (jistgħu jaffettwaw sa 1 persuna minn kull 10,000):
English: Several studies against placebo have shown that Fluenz may have some efficacy in adults.
Maltese: Diversi studji kontra l-plaċebo wrew li Fluenz jista' jkollu xi effikaċja f'persuni adulti.
English: Frequency and duration of vaccine virus shedding in these immunocompromised children and adolescents were comparable to that seen in healthy children and adolescents.
Maltese: Il-frekwenza u t-tul tat-tnaqqis tal-virus tat-tilqima f'dawn it-tfal u adolexxenti immunokompromessi kienu komparabbli għal dawk li ġew osservati fi tfal u adolexxenti b'saħħithom.
English: It is used in children and adolescents 24 months to less than 18 years of age.
Maltese: Jintuża fi tfal u adolexxenti li jkollhom 24 xahar sa inqas minn 18-il sena ta' età.
English: (See also, How Fluenz Tetra is given, in section 3).
Maltese: (Ara wkoll, Kif jingħata Fluenz Tetra, f'sezzjoni 3).
English: PACK SIZE OF 1 SINGLE-USE NASAL APPLICATOR PACK SIZE OF 1 SINGLE-USE NASAL APPLICATOR (IN A TRI-FOLD CARTON) PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (IN TRAYS) PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS
Maltese: DAQS TAL-PAKKETT TA' 10 APPLIKATURI TA' L-IMNIEĦER LI JINTUŻAW DARBA BISS (IN TRAYS)
English: • if you are allergic to gentamicin, gelatin or any of the other ingredients of this vaccine (listed in section 6 “Contents of the pack and other information”).
Maltese: • jekk inti allerġiku għal gentamicin, ġelatina, jew sustanzi oħra ta' din it-tilqima (dawn huma elenkati f'sezzjoni 6 “Kontenut tal-pakkett u informazzjoni oħra”).
English: The vaccine may contain residues of the following substances: egg proteins (e.g. ovalbumin) and gentamicin.
Maltese: It-tilqima jista' jkun fiha residwi tas-sustanzi li ġejjin: proteini tal-bajd (eż. ovalbumin) u gentamicin.
English: - Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
Maltese: Tfal u adolexxenti li jkollhom inqas minn età ta' 18-il sena li jkunu qed jirċievu terapija b'salicylate minħabba assoċjazzjoni tas-sindrome ta' Reye b'salicylates u infezzjoni b'influwenza wild-type.
English: 6 to 71 M 2,085 2002-2003
Maltese: D153-P514 Ewropa 6 sa 71 X 2,085 2002-2003
English: The concurrent use of Fluenz Tetra with antiviral agents that are active against influenza A and/or B viruses has not been evaluated.
Maltese: L-użu fl-istess ħin ta' Fluenz Tetra ma' mediċini antivirali li huma attivi kontra l-viruses tal-influwenza A u/jew B ma ġiex evalwat.
English: • muscle aches
Maltese: • uġigħ fil-muskoli
English: Name and address of the manufacturer of the biological active substances
Maltese: Isem u indirizz tal-manifattur tas-sustanzi bijoloġiċi attivi
English: Ask your doctor, nurse or pharmacist if you want more information about possible side effects from Fluenz Tetra.
Maltese: Staqsi lit-tabib, lill-infermiera jew lill-ispiżjar tiegħek jekk tixtieq aktar informazzjoni dwar l-effetti sekondarji possibbli minn Fluenz Tetra.
English: There was no evidence of significant maternal adverse outcomes in 138 pregnant women who had a record of receiving trivalent Fluenz in a US-based health insurance claims database.
Maltese: Ma kien hemm l-ebda evidenza ta' riżultati avversi sinifikanti materni f'138 nisa tqal li kellhom rekord li kienu jirċievu Fluenz trivalenti f'database ta' klejms tal-assigurazzjoni tas-saħħa bbażata fl-Istati Uniti.
English: This observation with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-liveattenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra.
Maltese: Din l-osservazzjoni bi Fluenz trivalenti hi rilevanti għall-użu ta' Fluenz Tetra għax Fluenz Tetra (tilqima kontra l-influwenza ħajja attenwata, nażali) hu identiku għal Fluenz bl-unika differenza li tkun iż-żieda tar-raba' razza (it-tieni razza B) ma' Fluenz Tetra.
English: Efficacy (95% CI) Matched strains
Maltese: Effikaċja (95% CI) Razez li Jaqblu
English: General disorders and administration site conditions Very common: Malaise
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna: Telqa
English: • severe allergic reaction: signs of a severe allergic reaction may include shortness of breath and swelling of the face or tongue.
Maltese: • reazzjoni allerġika severa: sinjali ta' reazzjoni allerġika jistgħu jinkludu, qtugħ ta' nifs u nefħa tal-wiċċ jew tal-ilsien.
English: Common: Pyrexia
Maltese: • dgħufija
English: • runny or stuffy nose
Maltese: • Ħruġ tal-lott uffiċjali
English: See Table 1 and 2 for a summary of efficacy results in the paediatric population.
Maltese: Ara Tabella 1 u 2 għal sommarju tar-riżultati tal-effikaċja fil-popolazzjoni pedjatrika.
English: No adverse effects on HIV viral load or CD4 counts were identified following trivalent Fluenz administration.
Maltese: Ma ġew identifikati l-ebda effetti avversi fuq l-ammont ta' virus tal-HIV jew fuq l-għadd ta' CD4 wara l-għoti ta' Fluenz trivalenti.
English: AstraZeneca S.p.A. Tel: +39 02 98011
Maltese: Tel: +39 02 98011
English: AstraZeneca AB SE-151 85
Maltese: SE-151 85 Södertälje L-Isvezja
English: Fluenz Tetra will be administered under the supervision of a doctor, nurse or pharmacist.
Maltese: Fluenz Tetra se jingħata taħt is-superviżjoni ta' tabib, infermiera jew spiżjar.
English: This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 1 and 10.
Maltese: Din it-tilqima hi ppreżentata bħala suspensjoni ta' sprej għall-imnieħer f'applikatur ta' l-imnieħer li jintuża darba biss (0.2 ml) f'daqs tal-pakkett ta' 1 u 10.
English: The suspension is colourless to pale yellow, clear to opalescent with a pH of approximately 7.2.
Maltese: Is-suspensjoni hi bla kulur sa lewn isfar ċar, minn ċara sa opalexxenti b'pH ta' madwar 7.2.
English: Study Number
Maltese: U KWANTITATTIVA
English: Uncommon: Epistaxis
Maltese: TWISSIJA(IET) SPEĊJALI
English: Children less than 24 months of age should not receive this vaccine because of the risk of side effects.
Maltese: Tfal li jkollhom inqas minn 24 xahar m'għandhomx jirċievu din it-tilqima minħabba r-riskju ta' effetti sekondarji.
English: • if you are already taking acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever).
Maltese: • jekk diġà qed tieħu acetylsalicylic acid (sustanza li tinsab f'ħafna mediċini li tintuża għas-solliev tal-uġigħ u biex tnaqqas id-deni).
English: Fluenz Tetra demonstrated immunologic non-inferiority to the two formulations of Fluenz as the upper bound for each of the four 95% CIs for the post-dose strain-specific GMT HAI antibody ratios was ≤ 1.5.
Maltese: L-immunoġeniċità ġiet evalwata billi tqabblu t-titres medji ġeometriċi (GMTs) ta' antikorpi tal-inibizzjoni tal-emagglutinazzjoni tas-serum li huma speċifiċi għar-razza (HAI) wara d-dożaġġ. Fluenz Tetra wera noninferjorità immunoloġika għaż-żewġ formulazzjonijiet ta' Fluenz għax l-upper bound għal kull wieħed mill-erba' 95% CIs għall-proporzjonijiet tal-antikorpi GMT HAI speċifiċi għar-razza wara d-dożaġġ kien ta' ≤ 1.5.
English: Vaccine recipients should be informed that Fluenz Tetra is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts.
Maltese: Dawk li jingħataw it-tilqima għandhom jiġu infurmati li Fluenz Tetra hu tilqima ta' virus ħaj attenwat u għandu l-potenzjal għal trasmissjoni lil kuntatti immunokompromessi.
English: 6 to 17 Y 2,211 2002-2003
Maltese: D153-P515 Ewropa 6 sa 17 S 2,211 2002-2003
English: Do not inject Fluenz Tetra.
Maltese: Tinjettax Fluenz Tetra.
English: How to store Fluenz Tetra
Maltese: X'fih Fluenz Tetra
English: Table 2 Fluenz Relative Efficacy in Active-controlled Paediatric Studies with Injectable Influenza Vaccine
Maltese: Tabella 2 Effikaċja Relattiva ta' Fluenz fi Studji Pedjatriċi Kkontrollati b'Mod Attiv b'Tilqima Kontra l-Influwenza li Tista' Tiġi Injettata
English: SINGLE-USE NASAL APPLICATOR
Maltese: Informazzjoni għall-utent
English: Immunogenicity was evaluated by comparing geometric mean titres (GMTs) of strain-specific serum haemagglutination inhibition (HAI) antibodies post dosing.
Maltese: L-għoti ta' mediċini antivirali kontra influwenza fi żmien ġimagħtejn mit-tilqima jista' jaffettwa r-rispons tat-tilqima.
English: 6 to 35 M 1,041
Maltese: 6 sa 35 X 1,616
English: A multicentre, randomised, double-blind, active-controlled, non-inferiority study was conducted to assess the immunogenicity of Fluenz Tetra compared to Fluenz (active control) in children and adolescents 2-17 years of age.
Maltese: Studju multiċentriku, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat b'mod attiv, dwar in-noninferjorità, twettaq biex jevalwa l-immunoġeniċità ta' Fluenz Tetra meta mqabbel ma' Fluenz (kontroll attiv) fi tfal u adolexxenti li kellhom minn sentejn sa 17-il sena.
English: *** fluorescent focus units.
Maltese: Dan il-prodott fih organiżmi ġenetikament modifikati (GMOs). *** unitajiet fokus fluworexxenti (fluorescent focus units).
English: • reduced appetite
Maltese: • nuqqas ta' aptit
English: Fluenz has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
Maltese: Fluenz wera superjorità fi 3 studji kkontrollati b'mod attiv b'tilqima kontra l-influwenza li tista' tiġi injettata.
English: This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2019/2020 season.
Maltese: Din it-tilqima hi konformi mar-rakkomandazzjoni tal-WHO (Emisferu tat-Tramuntana) u d-deċiżjoni tal-UE għall-istaġun 2019/2020.
English: Dosage
Maltese: Treddigħ
English: The co-administration of trivalent Fluenz with the live attenuated vaccines: measles, mumps, rubella, varicella and orally-administered poliovirus has been studied.
Maltese: Ġie studjat l-għoti flimkien ta' Fluenz trivalenti mat-tilqim attenwat ħaj: ħosba, gattone, ħosba Ġermaniża, ġidri r-riħ u poliovirus li jingħata mill-ħalq.
English: Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in Fluenz clinical studies.
Maltese: L-inċidenza massima tal-irkuprar tal-virus tat-tilqima seħħ minn jumejn sa 3 ijiem wara t-tilqima bi Fluenz fi studji kliniċi.
English: In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus.
Maltese: F'ċirkustanzi fejn kuntatt ma' individwi immunokompromessi b'mod sever ikun inevitabbli, ir-riskju potenzjali ta' trasmissjoni tal-virus tal-influwenza tal-tilqima għandu jintiżen kontra r-riskju li jinkiseb u jiġi trasmess virus tal-influwenza wild-type.
English: Fluenz efficacy
Maltese: Effikaċja ta' Fluenz
English: No clinically meaningful changes in immune responses to measles, mumps, varicella, orally-administered poliovirus or Fluenz have been observed.
Maltese: Ma kien osservat l-ebda tibdil klinikament sinifikanti fir-risponsi immuni għal ħosba, gattone, ġidri r-riħ, poliovirus li jingħata mill-ħalq jew Fluenz.
English: EXP
Maltese: AV006
English: Skin and subcutaneous tissue disorders Uncommon: Rash
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Mhux komuni: Raxx
English: Non-clinical data reveal no special hazard for humans based on conventional non-clinical studies of repeated dose toxicity, reproduction and developmental toxicity, local tolerance and neurovirulence.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq is-sistema riproduttiva u l-iżvilupp, tolleranza lokali u newrovirulenza, ma juri l-ebda periklu speċjali għall-bnedmin.
English: • fever
Maltese: • tinfaraġ
English: If influenza antiviral agents and Fluenz Tetra are administered concomitantly, revaccination should be considered based on clinical judgement.
Maltese: Jekk mediċini antivirali kontra influwenza u Fluenz Tetra jingħataw fl-istess ħin, għandu jiġi kkunsidrat tilqim mill-ġdid skont il-ġudizzju kliniku.
English: Age Range
Maltese: Numru tal-Istudju
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a veterinary medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Poland, Portugal, Slovakia, Spain and The Netherlands).
Maltese: Din hija proċedura fejn Stat Membru partikolari (l-'Istat Membru ta' referenza', f'dan il-każ ir-Renju Unit) jivvaluta mediċina veterinarja bil-għan li jagħti awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (l-'Istati Membri kkonċernati', f'dan il-każ l-Awstrija, il-Belġju, irRepubblika Ċeka, id-Danimarka, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, ilLussemburgu, il-Polonja, il-Portugall, is-Slovakkja, is-Slovenja, Spanja u n-Netherlands).
English: Amoxicillin is a bactericidal antibiotic belonging to the semisynthetic penicillin group.
Maltese: Amoxicillin huwa antibijotiku batteriċidja tal-grupp tal-peniċillina semisintetika.
English: Solamocta contains 800 mg amoxicillin trihydrate (equivalent to 697 mg amoxicillin) as an active substance per gram product.
Maltese: Solamocta fih 800 mg amoxicillin trihydrate (ekwivalenti għal 697 mg amoxicillin) bħala prodott b'sustanza attiva f'kull gramma.
English: The CVMP also recommended that the product information for Solamocta be amended.
Maltese: Is-CVMP irrakkomanda wkoll li tiġi emendata l-informazzjoni tal-prodott għal Solamocta.
English: Eurovet Animal Health B.V. submitted a marketing authorisation application, under Article 13(3) of Directive 2001/82/EC (i.e. hybrid or mixed application), for Solamocta to the United Kingdom via the decentralised procedure referring to the reference product Amoxinsol 100% w/w Powder for Oral Solution authorised in the United Kingdom.
Maltese: Eurovet Animal Health B.V. issottomettiet applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq, skont l-Artikolu 13(3) tad-Direttiva 2001/82/KE (jiġifieri applikazzjoni ibrida jew imħallta), għal Solamocta fir-Renju Unit permezz ta' proċedura deċentralizzata li tagħmel referenza għall-prodott ta' referenza Amoxinsol 100% w/w Trab għal Soluzzjoni Orali awtorizzat fir-Renju Unit.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that a satisfactory justification has been provided that the product, Solamocta, is eligible for a waiver from the requirement to demonstrate in vivo bioequivalence with the reference product in accordance with section 7.1.c) of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2) and that the excipients will not impact the bioavailability or safety of this product compared to the reference product.
Maltese: Abbażi ta' evalwazzjoni tad-dejta disponibbli attwalment u d-diskussjoni xjentifika fi ħdan il-Kumitat, is-CVMP ikkonkluda li ġiet ipprovduta ġustifikazzjoni sodisfaċenti li l-prodott, Solamocta, huwa eliġibbli għal rinunzja mir-rekwiżit biex tintwera bijoekwivalenza in vivo mal-prodott ta' referenza skont issezzjoni 7.1.c) tal-linja gwida tas-CVMP rigward it-tmexxija ta' studji ta' bijoekwivalenza għal prodotti mediċinali veterinarji (EMA/CVMP/016/00-Rev.2) u li l-eċċipjenti mhux se jkollhom impatt fuq ilbijodisponibilità jew is-sigurtà ta' dan il-prodott meta mqabbel mal-prodott ta' referenza.
English: On 4 November 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys.
Maltese: Fl-4 ta' Novembru 2015, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni talprodott mediċinali veterinarju Solamocta 697 mg/g Trab għall-Użu fl-Ilma tax-Xorb għat-Tiġieġ, Papri u Dundjani.
English: Denmark considered that Solamocta is essentially different from the reference product Amoxinsol 100% w/w Powder for Oral Solution and that these differences could be sufficient to require a formal bioequivalence study.
Maltese: IdDanimarka kkunsidrat li Solamocta huwa essenzjalment differenti mill-prodott ta' referenza Amoxinsol 100% w/w Trab għal Soluzzjoni Orali u li dawn id-differenzi jistgħu jkunu biżżejjed biex ikun hemm bżonn ta' studju formali ta' bijoekwivalenza.
English: 7 January 2016
Maltese: 7 ta' Jannar 2016 EMEA/90163/2016
English: However, the Member States were not able to reach an agreement and the Veterinary Medicines Directorate of the United Kingdom referred the matter to the CVMP for arbitration on 28 May 2015.
Maltese: Madankollu, l-Istati Membri ma kinux kapaċi jaslu għal ftehim u d-Direttorat tal-Mediċini Veterinarji tar-Renju Unit irrefera l-kwistjoni lis-CVMP għal arbitraġġ fit-28 ta' Mejju 2015.
English: Questions and answers on Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (amoxicillin trihydrate)
Maltese: Mistoqsijiet u tweġibiet dwar Solamocta 697 mg/g Trab għall-Użu fl-Ilma tax-Xorb għat-Tiġieġ, Papri u Dundjani (amoxicillin trihydrate)
English: What is Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys?
Maltese: X'inhu Solamocta 697 mg/g Trab għall-Użu fl-Ilma tax-Xorb għat-Tiġieġ, Papri u Dundjani?
English: Why was Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys reviewed?
Maltese: Għaliex Solamocta 697 mg/g Trab għall-Użu fl-Ilma tax-Xorb għat-Tiġieġ, Papri u Dundjani ġie rivedut?
English: Questions and answers on Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (amoxicillin trihydrate) EMA/23095/2016
Maltese: Mistoqsijiet u tweġibiet dwar Solamocta 697 mg/g Trab għall-Użu fl-Ilma tax-Xorb għat-Tiġieġ, Papri u Dundjani
English: Thus the CVMP concluded that the concerns expressed by Denmark should not prevent the granting of marketing authorisations and recommended marketing authorisation be granted in the concerned Member States.
Maltese: Għalhekk, is-CVMP ikkonkluda li t-tħassib muri mid-Danimarka ma għandux iwaqqaf l-għoti ta' awtorizzazzjoni għat-tqegħid fis-suq u rrakkomanda li tingħata awtorizzazzjoni għat-tqegħid fis-suq flIstati Membri kkonċernati.
English: ATC-vet code: QL03AX90.
Maltese: Kodici ATC veterinarja QL03AX90.
English: Oncept IL-2 lyophilisate
Maltese: Oncept IL-2
English: Lyophilisate: 6 x 1 dose Solvent: 6 x 1 ml
Maltese: Solvent : 6 x ml
English: Disodium phosphate dihydrate Potassium dihydrogen phosphate.
Maltese: Collagen hydrolysate Casein hydrolysate Sodium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate
English: Date of first authorisation: 03/05/2013 Date of last renewal: 20/03/2018
Maltese: Data tal-ewwel awtorizzazzjoni; 03/05/2013 Data tal-aħħar tiġdid; 20/03/2018
English: Store and transport refrigerated (2 °C-8 °C).
Maltese: Aħżen u ttrasporta fil-friġġ (2 °C- 8 °C).
English: Lyophilisate:
Maltese: Tqala u trddiegħ:
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other immunostimulants.
Maltese: Aġenti antineoplastiċi u immunomodulating, immunostimolanti oħra.
English: Feline interleukin-2 recombinant canarypox virus (vCP1338) ........................................ ≥ 106.0 EAID50
Maltese: Vajrus rikombinat tal-canarypox Feline interleukin-2 (vCP1338) ...................................≥ 106.
English: Solvent for Oncept IL-2
Maltese: VETERINARJU Solvent għal Oncept IL-2
English: Oncept IL-2 injected into the tumour bed thus delivers in situ a low dose of feline interleukin-2, which stimulates antitumour immunity while avoiding toxicity associated with systemic treatment.
Maltese: Oncept IL-2 injettat fit-tumour bed jagħti doża baxxa in situ tal-feline interleukin-2, li jistimola immunità kontra t-tumuri waqt li jevita tossiċità assoċjata ma' kura li tingħata biex tinfirex mal-ġisem kollu.
English: 1 dose
Maltese: 2 snin.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated ) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: Treatment course: 4 administrations at 1-week intervals (day 0, day 7, day 14, day 21) followed by 2 administrations at 2-week intervals (day 35, day 49).
Maltese: Kors tal-kura: 4 għotjiet f'intervalli ta' ġimgħa (jum 0, jum 7, jum 14, jum 21) segwiti minn 2 għotjiet f'intervalli ta' ġimagħtejn ( jum 35, jum 49).
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA(I)
English: Transient apathy and hyperthermia (above 39.5 °C) occurred commonly in field studies.
Maltese: Kien hemm b'mod komuni apatija tranżitorja u ipertermija ('l fuq minn 39.5˚C) waqt studji fuq ilpost.
English: 4.11 Withdrawal period(s)
Maltese: (ara sezzjoni 4.9)
English: In a randomized clinical study, cats from different origins presenting a fibrosarcoma without metastasis or lymph node involvement were included in two groups, one receiving the reference treatment - surgery and radiotherapy - and the other receiving Oncept IL-2 in addition to surgery and radiotherapy.
Maltese: Fi studju kliniku qtates minn oriġini differenti bi fibrosarcoma mingħajr metastasi jew effetti fuq il lymph nodes ġew maqsuma f'żewġ gruppi, wieħed li jieħu l-kura ta' kirurgija u radjoterapija u l-ieħor jieħu Oncept IL-2 flimkien mal-kirurgija u radioterapia.
English: The vaccine strain vCP1338 is a recombinant canarypox virus expressing feline interleukin-2 (IL-2).
Maltese: L-istrejn tal-vaċċin vCP1338 huwa vajrus rikombinant tal-Canarypox li jesprimi feline interleukin-2 (IL-2).
English: Oncept IL-2 lyophilisate and solvent for suspension for injection for cats
Maltese: VETERINARJU Oncept IL-2 lijofiliżat u solvent għal suspensjoni għal injezzjoni għal qtates
English: Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manufatturi tas-sustanza bijoloġika attiva
English: Lyophilisate: whitish homogeneous pellet.
Maltese: Pritkuna bajdanija u omoġena.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 6 vials of lyophilisate and 6 vials of solvent
Maltese: Kaxxa tal-kartun li fiha 6 kunjetti ta' lijofiliżat u 6 kunjetti ta' solvent
English: Oncept IL-2 treatment reduced the risk of relapse, from 6 months after the start of treatment, by approximately 56% after 1 year and 65% after 2 years.
Maltese: Il-kura bl-Oncept IL-2 naqqset irriskju ta' rikorrenza, minn 6 xhur, wara l-bidu tal-kura, b'56 % wara sena u 65 % wara sentejn.
English: Oncept IL-2 treatment reduced the risk of relapse, from 6 months after the start of treatment, by approximately 56% after 1 year and 65% after 2 years, compared to the control group.
Maltese: Il-kura bl-Oncept IL-2 naqqset irriskju ta' rikorrenza, minn 6 xhur, wara l-bidu tal-kura, b'56% wara sena u 65% wara sentejn.
English: Sucrose
Maltese: MERIAL
English: EXP {month/year}
Maltese: EAID*50