FrancophonIA/ELRC3.0 huggingface dataset:
English: Temozolomide SUN in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/l, and the thrombocyte count is ≥ 100 x 109/l.
Maltese: Fil-bidu ta' Ċiklu 2, id-doża tiżdied għal 200 mg/m2 jekk ittossiċità mhux ematoloġika CTC għal Ċiklu 1 huwa Grad ≤ 2 (ħlief għal alopeċja, tqalligħ u rimettar), jekk l- għadd assolut tan-newtrofili (ANC) jkun ≥ 1.5 x 109/l, u l-għadd tat-tromboċiti jkun ≥ 100 x 109/l.
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days.
Maltese: Pazjenti adulti u pedjatriċi minn 3 snin 'il fuq bi glijoma malinna rikorrenti jew progressiva:
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Maltese: sturdament, indeboliment talmemorja, indeboliment tal konċentrazzjoni, disfażja, disturbi newroloġiċi (NOS), newropatija, newropatija periferali, parasteżija, ma jitkellmux tajjeb, tregħid
English: Temozolomide SUN 100 mg hard capsules have a white opaque body and cap, imprinted in pink ink.
Maltese: Temozolomide SUN 100 mg kapsuli ibsin tal-ġelatina, b'għatu u korp opaki bojod, stampati b'linka roża.
English: Capsule shell Gelatin
Maltese: Kontenut tal-kapsula Lactose
English: Package Leaflet: Information for the user Temozolomide SUN 20 mg hard capsules temozolomide
Maltese: Informazzjoni għall-utent Temozolomide SUN 20 mg kapsuli ibsin temozolomide
English: † Including cases with fatal outcome * Frequencies estimated based on relevant clinical trials.
Maltese: Inkluż każijiet b'riżultat fatali * Il-frekwenzi stmati kienu bbażati fuq provi kliniċi rilevanti.
English: Temozolomide SUN 5 mg hard capsules have a white opaque body and cap, imprinted in green ink.
Maltese: Temozolomide SUN 5 mg kapsuli ibsin tal-ġelatina, b'għatu u korp opaki bojod, stampati b'linka ħadra.
English: Opportunistic infections and reactivation of infections Opportunistic infections (such as Pneumocystis jirovecii pneumonia) and reactivation of infections (such as HBV, CMV) have been observed during the treatment with TMZ (see section 4.8).
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu Infezzjonijiet opportunistiċi u attivazzjoni mill-ġdid ta' infezzjonijiet Ġew osservati infezzjonijiet opportunistiċi (bħal pnewmonja kkawżata minn Pneumocystis jirovecii) u attivazzjoni mill-ġdid ta' infezzjonijiet (bħal HBV, CMV) waqt il-kura b'TMZ (ara sezzjoni 4.8).
English: Temozolomide SUN 20 mg hard capsules
Maltese: Temozolomide SUN 20 mg kapsuli ibsin
English: EU/1/11/697/023 (5 capsules in blister) EU/1/11/697/024 (20 capsules in blister)
Maltese: EU/1/11/697/023(5 kapsuli ibsin) EU/1/11/697/024 (20 kapsuli ibsin)
English: - The other ingredients are: capsule content: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 "Temozolomide SUN contains lactose") capsule shell: gelatin, titanium dioxide (E171), sodium laurilsulfate printing ink: shellac, propylene glycol, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).
Maltese: kontenut tal-kapsula: lactose, sodium starch glycolate (Tip B), tartaric acid, stearic acid (ara sezzjoni 2 “Temozolomide SUN fih lactose”) qoxra tal-kapsula: gelatin, titanium dioxide (E171), sodium laurilsulfate linka tal-istampar: shellac, propylene glycol, red iron oxide (E172), isfar iron oxide (E172), titanium dioxide (E171).
English: Thus, prophylaxis against PCP is required for all patients receiving concomitant TMZ and RT for the 42-day regimen (with a maximum of 49 days) regardless of lymphocyte count.
Maltese: Għalhekk hija meħtieġa profilassi kontra PCP għall-pazjenti kollha li jkunu qegħdin jirċievu TMZ flimkien ma' RT għall- kors ta' 42 jum (b'massimu ta' 49 jum) irrispettivament mill-għadd tal-limfoċiti.
English: EU/1/11/697/015 (5 capsules in blister) EU/1/11/697/016 (20 capsules in blister)
Maltese: EU/1/11/697/015 (5 kapsuli ibsin) EU/1/11/697/016 (20 kapsuli ibsin)
English: Frequency groupings are defined according to the following convention: very common (≥ 1/10);
Maltese: Komuni ħafna (≥ 1/10); Komuni (≥ 1/100 sa < 1/10);
English: Package Leaflet: Information for the user Temozolomide SUN 140 mg hard capsules temozolomide
Maltese: Informazzjoni għall-utent Temozolomide SUN 140 mg kapsuli ibsin temozolomide
English: EU/1/11/697/021 (5 capsules in blister) EU/1/11/697/022 (20 capsules in blister)
Maltese: EU/1/11/697/021 (5 kapsuli ibsin) EU/1/11/697/022 (20 kapsuli ibsin)
English: EU/1/11/697/013 (5 capsules in blister) EU/1/11/697/014 (20 capsules in blister)
Maltese: EU/1/11/697/013 (5 kapsuli ibsin) EU/1/11/697/014(20 kapsuli ibsin)
English: If you have been previously treated with chemotherapy, your first dose of Temozolomide SUN will be 150 mg/m2 once daily for the first 5 days.
Maltese: Jekk tkun ġejt ikkurat bil-kimoterapija filpassat, l-ewwel doża tiegħek ta' Temozolomide SUN se tkun ta' 150 mg/m2 darba kuljum għall-ewwel 5 ijiem.
English: TMZ is administered orally at a dose of 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
Maltese: TMZ jingħata b'mod orali b'doża ta' 75 mg/m2 kuljum għal 42 jum flimkien ma' radjuterapija fokali (60
English: Vascular disorders Common:
Maltese: Mhux komuni::
English: Dermatitis, dry skin, erythema, pruritus
Maltese: Dermatite, ġilda xotta, ħmura, ħakk
English: Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of Temozolomide SUN.
Maltese: Tabella 5 tinkludi reazzjonjiet avversi li kienu rrappurtati fi provi kliniċi għall-glijoma malinna rikurrenti jew progressiva u wara t-tqegħid fis-suq ta' Temozolomide SUN.
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide SUN only
Maltese: Pazjenti b'tumuri li jkunu reġgħu tfaċċaw jew marru għall-agħar (glijoma malinna, bħal glijoblastoma multiforme jew astroċitoma anaplastika) li jkunu qed jieħdu Temozolomide SUN biss
English: EU/1/11/697/019 (5 capsules in blister) EU/1/11/697/020 (20 capsules in blister
Maltese: EU/1/11/697/019 (5 kapsuli ibsin) EU/1/11/697/020 (20 kapsuli ibsin)
English: Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Maltese: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/ Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/Nederland/Norge/Österreich/Portugal/ Slovenija/Slovenská republika/Suomi/Finland/Sverige Sun Pharmaceutical Industries Europe B.V.
English: In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
Maltese: Fi studju separat ta' fażi I, l-għoti ta' TMZ ma' ranitidine ma bidilx il-grad ta' assorbiment ta' temozolomide jew l-esponiment għall metabolit attiv tiegħu monomethyl triazenoimidazole carboxamide (MTIC).
English: Malignancies
Maltese: anġjoedima
English: Somnolence, dizziness, paresthesia
Maltese: Dijarea, uġigħ addominali, dispepsja
English: A treatment cycle with Temozolomide SUN lasts 28 days.
Maltese: Ċiklu ta' kura b'Temozolomide SUN idum 28 jum.
English: There may be up to 6 treatment periods (cycles).
Maltese: Jista' jkun hemm sa 6 perjodi (ċikli) ta' kura.
English: If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x 109/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Maltese: Jekk l-ANC jaqa' għal < 1.0 x 109/l jew l-għadd tal-plejtlets ikun < 50 x 109/l waqt xi ċiklu, iċ-ċiklu li jmiss għandu jitnaqqas b'livell wieħed ta' doża (ara sezzjoni 4.2).
English: - The other ingredients are: capsule content: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 "Temozolomide SUN contains lactose") capsule shell: gelatin, titanium dioxide (E171), sodium laurilsulfate printing ink: shellac, propylene glycol, black iron oxide (E172).
Maltese: kontenut tal-kapsula: lactose, sodium starch glycolate (Tip B), tartaric acid, stearic acid (ara sezzjoni 2 “Temozolomide SUN fih lactose”) qoxra tal-kapsula: gelatin, titanium dioxide (E171), sodium laurilsulfate linka tal-istampar: shellac, propylene glycol, black iron oxide (E172).
English: Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption,
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000): ħmura tal-ġilda, urtikarja (ħorriqija), eruzzjoni tal-ġilda, reazzjonijiet allerġiċi.
English: CTC non-haematological toxicity (except for alopecia, nausea, vomiting)
Maltese: Tossiċità mhux ħematoloġika CTC (ħlief għal alopeċja, tqallih, rimettar)
English: - The other ingredients are: capsule content: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 "Temozolomide SUN contains lactose") capsule shell: gelatin, titanium dioxide (E171), sodium laurilsulfate printing ink: shellac, propylene glycol, red iron oxide (E172).
Maltese: kontenut tal-kapsula: lactose, sodium starch glycolate (Tip B), tartaric acid, stearic acid (ara sezzjoni 2 “Temozolomide SUN fih lactose”) qoxra tal-kapsula: gelatin, titanium dioxide (E171), sodium laurilsulfate linka tal-istampar: shellac, propylene glycol, red iron oxide (E172).
English: Contains lactose.
Maltese: Tnaqqis tal-piż
English: Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
Maltese: konfużjoni, indeboliment talmemorja, indeboliment tal konċentrazzjoni, newropatija, parasteżija, ma jitkellmux tajjeb, tregħid
English: - The other ingredients are: capsule content: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 "Temozolomide SUN contains lactose") capsule shell: gelatin, titanium dioxide (E171), sodium laurilsulfate printing ink: shellac, propylene glycol, yellow iron oxide (E172).
Maltese: kontenut tal-kapsula: lactose, sodium starch glycolate (Tip B), tartaric acid, stearic acid (ara sezzjoni 2 “Temozolomide SUN fih lactose”) qoxra tal-kapsula: gelatin, titanium dioxide (E171), sodium laurilsulfate linka tal-istampar: shellac, propylene glycol, isfar iron oxide (E172).
English: Dyspnoea, coughing
Maltese: OĦRAJN QOXRA HAWN
English: Hard gelatin capsules, with white opaque cap and body, imprinted in red ink.
Maltese: Kapsuli ibsin tal-ġelatina, b'għatu u korp opaki bojod, stampati b'linka roża.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Isem inventat Qawwa
English: ATCvet code: QI06AJ05.
Maltese: QI06AJ05
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C ).
English: EU/2/04/047/001 lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/047/002 lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Maltese: EU/2/04/047/001 Lijofiliżat (10 fliexken ta' doża ) + solvent (10 fliexken ta' doża) EU/2/04/047/002 Lijofiliżat (50 flixkun ta' doża) + solvent (50 flixkun ta' doża)
English: Lyophilisate (10x1 dose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Maltese: Lijofiliżat (doża 10x1 ) + solvent (10x1)
English: 2 egg infective dose 50%
Maltese: 1: doża infettiva tas-cell culture 50% 2: doża infettiva tal-bajda 50%
English: Under field conditions, only sub-group A is infective and immunisation against sub-group A provides full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but does not replicate in the cat.
Maltese: F'kundizzjonijiet normali, s-sotto-grupp A biss huwa infettiv u limmunizzazzjoni kontra s-sotto-grupp A jipprovdi protezzjoni totali kontra A, B u C.
English: Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Maltese: Sid l-Awtorizzazzjoni tal-Kummerċ Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus, Chlamydophila felis, feline panleucopenia virus and feline leukaemia virus.
Maltese: Tistimola immunità attiva kontra l-virus tal-ħerpes tar-rinotrakeite fil-qtates, kaliċivirus fil-qtates, Chlamydophila felis, il-virus tal-panlewkopenja fil-qtates u l-virus tal-lewkemja fil-qtates.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ...................................................................... ≥ 103.0 EID502 Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Maltese: Virus tal-Ħerpes attenwat tar-rinotrakeite fil-qtates (FHV strejn F2)......................... ≥ 104.9 CCID501 kaliċivirus fil-qtates (strejn FCV 431 u G1) antiġeni ................................................... ≥ 2.0 ELISA U. Chlamydophila felis attenwat (strejn 905) ................................................................... ≥ 103.0 EID502
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta kura waħda) - 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: FeLV recombinant canarypox virus (vCP97)................................................................... ≥ 107.2 CCID50.
Maltese: virus rikombinant tal-canarypox FeLV (vCP97) ........................................................... ≥ 107.2 CCID501
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against Chlamydophila felis infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs, - against leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Maltese: Immunizzazzjoni attiva tal-qtates ta' 8 ġimgħat u akbar: - kontra r-rinotrakeite virali fil-qtates biex tnaqqas sinjali kliniċi, - kontra l-infezzjoni tal-kaliċivirus biex tnaqqas sinjali kliniċi
English: Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection.
Maltese: VETERINARJU Purevax RCPCh FeLV lijofiliżat u solvent għal suspensjoni għall-injezzjoni.
English: In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1or 2 days).
Maltese: F'kundizzjonijiet normali tal-użu, jista' jkun hemm apatija li tgħaddi u anoreksja, u wkoll żieda fittemperatura tal-ġisem (li ddum normalment għal ġurnata jew tnejn).
English: As a consequence, the vaccine induces an immune status against feline leukaemia virus.
Maltese: Konsegwentement, il-vaċċin jinduċi stat ta' immunità kontra l-virus tal- lewkemja fil-qtates.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/)
English: FeLV recombinant canarypox virus (vCP97) .................................................................. ≥ 107.2 CCID501 1 cell culture infective dose 50%
Maltese: virus rikombinant tal-canarypox FeLV (vCP97) ........................................................ ≥ 107.2 CCID501
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 tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/).
English: Lyophilisate and solvent for suspension for injection.
Maltese: lijofiliżat u solvent għal suspensjoni għall-injezzjoni.
English: Cats
Maltese: UŻU
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZI BIJOLOĠIĊI ATTIVI U MANIFATTUR RESPONSABBLI
English: It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
Maltese: Huwa rakkomandat li jsir test għal FeLV antigenaemia qabel it-tilqim.
English: The feline leukaemia vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
Maltese: L-istrejn tal- vaċċin tal- lewkemja fil-qtates huwa virus rikombinat tal-canarypox li jesprimi l-ġeni talenv u gag ta' FeLV-A.
English: Primary vaccination course: - first injection: from 8 weeks of age, - second injection: 3 to 4 weeks later.
Maltese: - l-ewwel injezzjoni: minn età ta' 8 ġimgħat, - it-tieni injezzjoni: 3 sa' 4 ġimgħat wara.
English: The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the Chlamydophila felis and feline leukaemia components.
Maltese: L-immunità wara l-aħħar tilqima tibqa 3 snin għall-komponenti tar-rinotrakeite, kaliċivirosi u panlewkopenja u sena għall-komponenti tal-Chlamydophila felis u lewkimja fil-qtates.
English: Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the chlamydiosis and feline leukaemia components and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Maltese: Tilqim mill-ġdid: - l-ewwel ripetizzjoni tal-vaċċinazzjoni għandha tingħata għall-komponenti kollha sena wara l-ewwel kors ta' vaċċinazzjoni, tilqim sussegwenti għandhom jingħataw kull sena għall-komponent tal-klamidjosi u lewkimja filqtates, u f'intervalli sa tliet snin għall-komponenti tar-rinotrakeite, tal-kaliċivirosi u tal panlewkopenja.
English: Manufacturer responsible for the batch release: MERIAL
Maltese: Manifattur responsabbli għall-ħrug tal-lott MERIAL
English: FPV (PLI IV) ..................................................................................................................... ≥ 103.5 CCID50
Maltese: FPV (PLI IV).................................................. ............................................................... ≥ 103.5 CCID501 Virus rikombinant tal-canarypox FeLV (vCP97)........................................................... ≥ 107.2 CCID50
English: Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.
Maltese: Lijofiliżat (doża 50x1) + solvent (50 flixkun ta' doża50x1)
English: EMA/622534/2010 EMEA/V/C/002231
Maltese: EMEA/V/C/002231
English: Other information about BTVPUR:
Maltese: Informazzjoni oħra dwar BTVPUR:
English: Further information on BTVPUR can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar BTVPUR tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: BTVPUR received a marketing authorisation valid throughout the EU on 12 April 2016.
Maltese: BTVPUR ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-12 ta' April 2016.
English: BTVPUR is a vaccine.
Maltese: BTVPUR huwa vaċċin.
English: As the company had supplied additional information requested, the ‘exceptional circumstances' ended on 6 May 2013.
Maltese: Minħabba li l-kumpanija kienet ipprovdiet l-informazzjoni addizzjonali mitluba, iċ-"ċirkustanzi ta' eċċezzjoni" intemmew fis-6 ta' Mejju 2013.
English: Previously known as BTVPUR AlSap 1-8 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: Preċedentement magħruf bħala BTVPUR AlSap 1-8 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom jekk l-annimali jiġu esposti għall-virus tal-marda tal-ilsien blu, is-sistema immunitarja tagħhom tkun kapaċi tipproduċi antikorpi aktar malajr.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) that enhance the response of the immune system.
Maltese: Il-vaċċin fih ukoll “adjuvanti” (aluminium hydroxide u saponin) li jtejbu r-rispons tas-sistema immunitarja.
English: There can also be a slight rise in body temperature, usually of no more than 1 °C, in the 24 hours following vaccination.
Maltese: Jista' jkun hemm ukoll żieda żgħira fit-temperatura tal-ġisem, normalment ta' mhux aktar minn 1 ℃, fl-24 siegħa wara t-tilqima.
English: What are the risks associated with BTVPUR?
Maltese: X'inhuma r-riskji assoċjati ma' BTVPUR?
English: BTVPUR is developed using data from the vaccine BTVPUR AlSap 1-8 originally authorised under ‘exceptional circumstances' on 17 December 2010 because limited information was available at the time of approval.
Maltese: BTVPUR jiġi żviluppat permezz ta' data mill-vaċċin BTVPUR AlSap 1-8 li kien oriġinarjament awtorizzat taħt "ċirkustanzi ta' eċċezzjoni" fis-17 ta' Diċembru 2010 minħabba li kien hemm informazzjoni limitata meta saret l-approvazzjoni.
English: BTVPUR contains bluetongue virus of one or two types selected from serotypes 1, 2, 4 and 8.
Maltese: BTVPUR fih il-virus tal-marda tal-ilsien blu ta' tip wieħed jew żewġ tipi magħżula mis-serotipi 1, 2, 4 u 8.
English: The company also presented results from a series of studies conducted with vaccines of similar composition but including different serotypes from the ones in BTVPUR to provide supportive information that could be used to calculate the effectiveness of the vaccine.
Maltese: Il-kumpanija ppreżentat ukoll riżultati minn serje ta' studji li saru b'vaċċini b'kompożizzjoni simili iżda li jinkludu serotipi differenti minn dawk f'BTVPUR biex tipprovdi informazzjoni ta' sostenn li tista' tintuża biex tikkalkula l-effikaċja tal-vaċċin.
English: Vaccination may be followed by a small local swelling at the injection site, which normally resolves within five weeks.
Maltese: It-tilqim jista' jiġi segwit minn nefħa lokali żgħira fis-sit tal-injezzjoni, li normalment tgħaddi fi żmien ħames ġimgħat.
English: In 2016 the CVMP considered that data submitted allowed BTVPUR AlSap 1-8 to convert to a BTVPUR vaccine based on three possible serotypes with one or two serotypes selected depending on the need.
Maltese: Fl-2016, is-CVMP ikkunsidra li ddata sottomessa ppermettiet li BTVPUR AlSap 1-8 jinbidel f'vaċċin BTVPUR ibbażat fuq tliet serotipi possibbli b'serotip wieħed jew tnejn magħżula skont il-bżonn.
English: The vaccine contains inactivated (killed) bluetongue virus.
Maltese: Il-vaċċin fih il-virus inattivat (maqtul) tal-marda tal-ilsien blu.
English: Why is BTVPUR authorised in the EU?
Maltese: Għaliex BTVPUR huwa awtorizzat fl-UE?