FrancophonIA/ELRC3.0 huggingface dataset:
English: Each tablet contains 21.4 mg sorbitol (E420) For the full list of excipients, see section 6.1.
Maltese: Kull pillola fiha 21.4 mg sorbitol (E420)
English: Insomnia, depression
Maltese: Nuqqas ta' rqad, dipressjoni
English: Other
Maltese: Ansjetà
English: EU/1/09/610/028 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/09/610/038 Kaxxi tal-kartun ta' 90x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Maltese: Trabi li ommijiethom ikunu ħadu antagonisti tar-riċetturi ta' angiotensin II, għandhom ikunu taħt osservazzjoni mill-qrib għal pressjoni baxxa (ara sezzjonijiet 4.3 u 4.4).
English: Aluminium-Aluminium peelable perforated unit dose blisters and aluminium-aluminium perforated unit-dose blisters.
Maltese: Folji ta' doża waħda perforati li jistgħu jitqaxxru tal-aluminju-aluminju u folji ta' doża waħda perforati tal-aluminju-aluminju.
English: Patients with rare hereditary problems of fructose intolerance should not take Telmisartan Teva.
Maltese: Pazjenti li għandhom problemi ereditarji ta' intolleranza għall-fructose m'għandhomx jieħdu Telemisartan Teva.
English: Hypotension2, orthostatic hypotension
Maltese: Pazjenti b'indeboliment epatiku
English: In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo.
Maltese: Fil-prova PRoFESS, kienet osservata żieda fl-inċidenza ta' sepsis b'telmisartan meta mqabbel mal-plaċebo.
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Teva 80 mg tablets telmisartan
Maltese: Kull pillola fiha 80 mg telmisartan
English: The safety and efficacy of Telmisartan Teva in children and adolescents aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Telmisartan Teva fit-tfal u adoloxxenti li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
English: Magnesium stearate
Maltese: Mhux applikabbli
English: EU/1/09/610/041 Cartons of 14x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/042 Cartons of 28x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/043 Cartons of 30x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/044 Cartons of 40x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/045 Cartons of 56x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/046 Cartons of 60x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/047 Cartons of 84x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/048 Cartons of 90x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/049 Cartons of 98x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/050 Cartons of 100x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/09/610/061 Carton of 30 tablets in aluminium-aluminium blister
Maltese: Kaxxi tal-kartun ta' 56x1 pillola f'folji perforati ta' doża waħda li jistgħu jitqaxxru magħmulin minn aluminju-aluminju EU/1/09/610/026 Kaxxi tal-kartun ta' 60x1 pillola f'folji perforati ta' doża waħda li jistgħu jitqaxxru magħmulin minn aluminju-aluminju EU/1/09/610/027 Kaxxi tal-kartun ta' 84x1 pillola f'folji perforati ta' doża waħda li jistgħu jitqaxxru magħmulin minn aluminju-aluminju EU/1/09/610/028 Kaxxi tal-kartun ta' 90x1 pillola f'folji perforati ta' doża waħda li jistgħu jitqaxxru magħmulin minn aluminju-aluminju
English: Other medicines and Telmisartan Teva
Maltese: Mediċini oħra u Telmisartan Teva
English: EU/1/09/610/006 Cartons of 60x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Maltese: EU/1/09/610/056 Kaxxi tal-kartun ta' 60x1 pillola f'folji perforati ta' doża waħda magħmulin minn aluminju-aluminju
English: Galafold is available as capsules (123 mg).
Maltese: Galafold jiġi f'kapsuli (123 mg).
English: The full EPAR for Galafold 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: The summary of the opinion of the Committee for Orphan Medicinal Products for Galafold can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Galafold jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Galafold contains the active substance migalastat.
Maltese: Galafold fih is-sustanza attiva migalastat.
English: This is a summary of the European public assessment report (EPAR) for Galafold.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Galafold.
English: Other information about Galafold
Maltese: Informazzjoni oħra dwar Galafold
English: The first study, which compared Galafold with placebo (a dummy treatment) in 67 patients, looked at the proportion of patients who responded to treatment (defined as a reduction of at least 50% in GL-3 deposits in the kidneys).
Maltese: L-ewwel studju, li qabbel Galafold mal-plaċebo (kura finta) f'67 pazjent, ħares lejn il-proporzjon ta' pazjenti li rrispondew għal kura (definit bħala t-tnaqqis ta' mill-inqas 50 % fid-depożiti tal-GL-3 filkliewi).
English: This is a rare inherited disorder where patients have various mutations (changes) in the gene responsible for the production of an enzyme called alpha-galactosidase A, which normally breaks down a fatty substance called globotriaosylceramide (GL-3).
Maltese: Din hija disturb rari li jintiret fejn il-pazjenti jkollhom diversi mutazzjonijiet (bidliet) fil-ġeni responsabbli għall-produzzjoni tal-enzima msejħa alpha-galactosidase A, li normalment tkisser issustanza xaħmija msejħa globotriaosylceramide (GL-3).
English: Galafold has been investigated in two main studies involving a total of 127 patients with Fabry disease.
Maltese: Galafold ġie studjat f'żewġ studji ewlenin li fihom b'kollox ħadu sehem 127 pazjent li jbatu mill-mard ta' Fabry.
English: Why is Galafold approved?
Maltese: Għaliex ġiet approvat Galafold?
English: Overall, Galafold was not found to be more effective than placebo at reducing GL-3 deposits; however, additional analyses including only patients with those genetic mutations that can be treated with Galafold showed that patients responded better to Galafold than to placebo after 6 months of treatment.
Maltese: B'mod ġenerali, Galafold ma nstabx li huwa iżjed effettiv mill-plaċebo fit-tnaqqis tad-depożiti tal-GL-3; madankollu, l-analiżi addizzjonali li tinkludi biss pazjenti b'dawk il-mutazzjonijiet ġenetiċi li jistgħu jiġu kkurati b'Galafold uriet li l-pazjenti rrispondew aħjar għal Galafold milli għall-plaċebo wara 6 xhur ta' kura.
English: Because the number of patients with Fabry disease is low, the disease is considered ‘rare' and Galafold was designated an ‘orphan medicine' (a medicine used in rare diseases) on 22 May 2006.
Maltese: Peress li n-numru ta' pazjenti li jbatu mill-marda ta' Fabry huwa wieħed baxx, il-marda titqies bħala ‘rari', u Galafold ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-22 ta' Mejju
English: What are the risks associated with Galafold?
Maltese: X'inhuma r-riskji assoċjati ma' Galafold?
English: The active substance in Galafold, migalastat, attaches to certain unstable forms of alpha-galactosidase A, stabilising the enzyme.
Maltese: Is-sustanza attiva f'Galafold, migalastat, teħel ma' ċerti forom instabbli ta' alpha-galactosidase A, u b'hekk tistabbilixxi l-enżima.
English: The Committee noted that Galafold was studied in a limited number of patients, however the available evidence is considered sufficient for such a rare disease.
Maltese: Il-Kumitat innota li Galafold ġie studjat f'numru limitat ta' pazjenti, madankollu l-evidenza disponibbli hija meqjusa suffiċjenti għal marda rari bħal din.
English: The second study, in 60 patients, compared Galafold with the medicines agalsidase alfa or agalsidase beta, two treatments that replace the missing enzyme.
Maltese: It-tieni studju, f'60 pazjent, qabbel Galafold mal-mediċini agalsidase alfa jew agalsidase beta, żewġ kuri li jissostitwixxu l-enzima nieqsa.
English: Regarding safety, Galafold was well-tolerated.
Maltese: Rigward is-sigurtà, Galafold kien ittollerat tajjeb.
English: A risk management plan has been developed to ensure that Galafold is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Galafold jintuża bl-aktar mod sigur possibbli.
English: As a result, GL-3 cannot be broken down and it builds up in various cells in the body, including in the heart and kidneys.
Maltese: B'riżultat ta' dan, il-GL-3 ma tkunx tista' titkisser u takkumula f'diversi ċelloli filġisem, inkluż fil-qalb u fil-kliewi.
English: Galafold is only for use in patients with certain mutations in the alpha-galactosidase A gene.
Maltese: Galafold huwa biss għall-użu f'pazjenti b'ċerti mutazzjonijiet fil-ġene alpha-galactosidase A.
English: Galafold is a medicine used to treat patients aged 16 years or over with Fabry disease.
Maltese: Galafold huwa mediċina użata biex tikkura pazjenti li għandhom 16-il sena jew iżjed bil-marda ta' Fabry.
English: The CHMP also noted that Galafold is taken by mouth and this could be an advantage compared with other authorised treatments such as enzyme replacement which are given by infusion (drip) into a vein.
Maltese: Is-CHMP innota wkoll li Galafold jittieħed mill-ħalq u dan jista' jkun ta' vantaġġ meta mqabbel ma' kuri awtorizzati oħrajn bħas-sostituzzjoni tal-enzima li jingħataw permezz ta' infużjoni (dripp) fil-vina.
English: Strength Pharmaceutical Form
Maltese: Għamla Farmaċewtika
English: EU Number
Maltese: Numru tal-MA
English: (Invented) name
Maltese: Isem (ivvintat) Qawwa
English: CMDh agreement
Maltese: Ftehim mas-CMDh
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC;
Maltese: • Il-Kumitat tal-Evalwazzjoni tar-Riskju fil-qasam tal-Farmakoviġilanza (PRAC) ikkunsidra lproċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE;
English: The CMDh amended the product information accordingly, revising the wording of Section 4.2 of the SmPC as follows: “In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day” and clarifying the wording of the recommendation in children up to 40 kg in weight.
Maltese: Is-CMDh emenda l-informazzjoni tal-prodott kif xieraq, billi rriveda l-formulazzjoni tas-Sezzjoni 4.2 tal-SmPC kif ġej: “F'adulti u tfal li jiżnu aktar minn 40 kg, id-doża massima ta' kuljum hija 100 mg kuljum” u ċċara l-formulazzjoni tar-rakkomandazzjoni fi tfal li jiżnu sa 40 kg.
English: On 7th March 2014, the Hungarian competent authority was informed of new data on the potential risk for developing QT interval prolongation and/or Torsades de Pointes after exposure to hydroxyzine.
Maltese: Fis-7 ta' Marzu 2014, l-awtorità kompetenti Ungeriża ġiet infurmata dwar data ġdida dwar riskju potenzjali li jiġi żviluppat titwil fl-intervall QT u/jew Tosades de Pointes wara esponiment għal hydroxyzine.
English: As the recommendation in children below 40 kg in weight is 2 mg/kg/day, the maximum daily dose in this population is 80 mg per day.
Maltese: Peress li r-rakkomandazzjoni fi tfal li jiżnu anqas minn 40 kg hija 2 mg/kg/kuljum, id-doża massima ta' kuljum f'din il-popolazzjoni hija 80 mg kuljum.
English: Based on the available non-clinical data, the PRAC concluded that hydroxyzine has the potential to block hERG channels and other types of cardiac channels, resulting in a potential risk of QT interval prolongation and cardiac arrhythmia events.
Maltese: Abbażi tad-data mhux klinika disponibbli, il-PRAC ikkonkluda li hydroxyzine għandu l-potenzjal li jimblokka l-kanali hERG u tipi oħrajn ta' kanali kardijaċi, u dan jirriżulta f'riskju potenzjali ta' titwil fl-intervall QT u avvenimenti ta' arritmija kardijaka.
English: • The PRAC considered that the available safety data confirms the potential risk of QT interval prolongation associated with the use of hydroxyzine;
Maltese: • Il-PRAC ikkunsidra li d-data dwar is-sigurtà disponibbli tikkonferma r-riskju potenzjali ta' titwil fl-intervall QT assoċjat mal-użu ta' hydroxyzine;
English: The PRAC recommended that hydroxyzine should be contra-indicated in patients with a known acquired or congenital QT interval prolongation as well as in patients with a known risk factor to QT interval prolongation including a known cardiovascular disease, significant electrolytes imbalance (hypokalaemia, hypomagnesaemia), family history of sudden cardiac death, significant bradycardia, concomitant use with other drugs known to prolong the QT interval and/or induce Torsades de Pointes.
Maltese: Il-PRAC irrakkomanda li hydroxyzine għandu jkun kontraindikat f'pazjenti b'titwil fl-intervall QT miksub jew konġenitali magħruf kif ukoll f'pazjenti b'fattur ta' riskju magħruf għal titwil fl-intervall QT inkluż mard kardjovaskulari magħruf, żbilanċ sinifikanti fl-elettroliti (ipokalimja, ipomagnesimja), storja fil-familja ta' mewt kardijaka għall-għarrieda, bradikardija sinifikanti, l-użu fl-istess ħin ma' mediċini oħrajn magħrufa li jtawlu lintervall QT u/jew jinduċu Torsades de Pointes.
English: • The PRAC reviewed the totality of the available data in relation to the potential risk for developing QT interval prolongation and/or Torsades de Pointes after exposure to hydroxyzine, including pre-clinical data, clinical efficacy and safety data and post-marketing safety data, the MAHs' submissions as well as reports from the Paediatric Committee and the Geriatric Expert Group;
Maltese: • Il-PRAC irrieżamina d-data kollha disponibbli fir-rigward tar-riskju potenzjali li jiġi żviluppat titwil fl-intervall QT u/jew Torsades de Pointes wara esponiment għal hydroxyzine, inkluż data ta' qabel l-użu kliniku, data dwar l-effikaċja klinika u s-sigurtà u data dwar is-sigurtà ta' wara ttqegħid fis-suq, is-sottomissjonijiet tal-MAHs kif ukoll ir-rapport mill-Kumitat Pedjatriku u lGrupp ta' Esperti Ġerjatriċi;
English: A maximum daily dose of 100 mg was found to be efficacious and well-tolerated and the PRAC therefore recommended restricting the maximum daily dose to 100 mg per day in adults, with corresponding changes in the paediatric and elderly populations, based on pharmacokinetic data.
Maltese: Doża ta' kuljum massima ta' 100 mg instabet li hija effikaċi u ttollerata sew u għalhekk il-PRAC irrakkomanda restrizzjoni tad-doża massima ta' kuljum għal 100 mg kuljum fl-adulti, b'bidliet korrispondenti filpopolazzjoni pedjatrika u dik anzjana, abbażi tad-data farmakokinetika.
English: Hydroxyzine hydrochloride is a first generation antihistamine first authorised in the 1950s and available in 24 EEA member states.
Maltese: Hydroxyzine hydrochloride huwa antistamina tal-ewwel ġenerazzjoni li ġie awtorizzat għall-ewwel darba fis-snin ħamsin u huwa disponibbli fl-24
English: However, the CMDh considered that additional changes were necessary to the wording proposed for the Summary of Product Characteristics (SmPC) and the Package Leaflet, to provide appropriate guidance on the recommendation regarding the maximum daily dose in children and adolescents over 40 kg of body weight but below 18 years of age.
Maltese: Madankollu, is-CMDh ikkunsidra li kienu meħtieġa bidliet addizzjonali fil-formulazzjoni proposta għas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) u l-Fuljett ta' Tagħrif, biex tiġi pprovduta gwida xierqa dwar ir-rakkomandazzjoni rigward id-doża massima ta' kuljum fi tfal u adolexxenti li għandhom piż tal-ġisem ta' aktar minn 40 kg iżda li għandhom anqas minn 18-il sena.
English: For products with a paediatric formulation (syrup or oral solution), consideration should be given to making available an appropriate measuring device.
Maltese: Għal prodotti b'formulazzjoni pedjatrika (ġulepp jew soluzzjoni orali), għandu jiġi kkunsidrat li jitqiegħed għad-dispożizzjoni apparat ta' kejl xieraq.
English: 2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation
Maltese: 2 - Spjegazzjoni ddettaljata tar-raġunijiet xjentifiċi għal differenzi mirrakkomandazzjoni tal-PRAC
English: This potential risk was confirmed by clinical and post-marketing data, which also identified the at-risk population as consisting of patients with risk factors for QT interval prolongation, such as cardiac medical history, concomitant medications associated with QT interval prolongation and electrolyte imbalance.
Maltese: Dan ir-riskju potenzjali kien ikkonfermat minn data klinika u ta' wara t-tqegħid fis-suq, li identifikat ukoll il-popolazzjoni f'riskju bħala li tikkonsisti minn pazjenti b'fatturi ta' riskju għal titwil fl-intervall QT, bħal storja medika kardijaka, medikazzjonijiet li jittieħdu fl-istess ħin assoċjati ma' titwil fl-intervall QT u żbilanċ fl-elettroliti.
English: The risk did not differ between indications and no dose effect could be observed based on postmarketing data, despite pre-clinical data suggesting that hydroxyzine has a dose-dependent hERG inhibitory effect.
Maltese: Ir-riskju ma kienx differenti bejn l-indikazzjonijiet u ma seta' jiġi osservat ebda effett tad-doża abbażi ta' data ta' wara t-tqegħid fis-suq, minkejja dejta ta' qabel l-użu kliniku li tissuġġerixxi li hydroxyzine għandu effett inibitorju hERG li jiddependi mid-doża.
English: The PRAC reviewed all available data, including pre-clinical data, clinical efficacy and safety data and post-marketing safety data, as well as input from the PDCO and the GEG, in the context of its review of the potential risk for developing QT interval prolongation and Torsades de Pointes after exposure to hydroxyzine.
Maltese: Il-PRAC irrieżamina d-data kollha disponibbli, inkluż id-data ta' qabel l-użu kliniku, id-data dwar leffikaċja klinika u s-sigurtà u d-data dwar is-sigurtà ta' wara t-tqegħid fis-suq, kif ukoll il-kontribut tal-PDCO u l-GEG, fil-kuntest tar-rieżami tiegħu tar-riskju potenzjali li jiġi żviluppat titwil fl-intervall QT u Torsades de Pointes wara esponiment għal hydroxyzine.
English: The PRAC also requested the MAHs to circulate a ‘Direct healthcare professional' communication (DHPC), assess the effectiveness of the risk minimisation measures and continue to monitor the risks of QT interval prolongation, Torsades de Pointes, ventricular arrhythmia, sudden death and cardiac arrest.
Maltese: Il-PRAC talab ukoll lill-MAHs biex jiċċirkolaw komunikazzjoni 'Diretta tal-Professjonisti fil-Qasam tas-Saħħa' (DHPC), jivvalutaw l-effikaċja tal miżuri ta' minimizzazzjoni tar-riskju u jkomplu jissorvejlaw ir-riskji ta' titwil fl-intervall QT, Tosadesde Pointes, arritmija ventrikulari, mewt għall-għarrieda u arrest kardijaku.
English: Because 40 kg in weight is generally considered to be the weight of a child aged 12 years, the CMDh considered that based on the available pharmacokinetic data, the adult maximum daily dose of 100 mg per day would be considered appropriate also for children over 40 kg in weight.
Maltese: Minħabba li piż ta' 40 kg huwa ġeneralment ikkunsidrat bħala l-piż ta' tfal ta' 12-il sena, isCMDh ikkunsidra li abbażi tad-data farmakokinetika disponibbli, id-doża massima ta' kuljum taladulti ta' 100 mg kuljum tkun ikkunsidrata xierqa anki għal tfal li jiżnu aktar minn 40 kg.
English: The PRAC considered that the potential risk of QT interval prolongation and Torsades de Pointes can be adequately minimised through appropriate risk minimisation measures targeting the identified risk factors and restricting the use of hydroxyzine, in particular in the atrisk populations.
Maltese: Il-PRAC ikkunsidra li r-riskju potenzjali ta' titwil fl-intervall QT u ta' Torsades de Pointes jista' jitnaqqas b'mod adegwat permezz ta' miżuri ta' minimizzazzjoni tar-riskju xierqa li jkollhom fil-mira l-fatturi ta' riskju identifikati u li jillimitaw l-użu ta' hydroxyzine, b'mod partikolari fil-popolazzjonijiet f'riskju.
English: (the half-life in children 12 months of age is 4 hours, compared to 11 hours for children aged 14 years, 14 hours in adults and 29 hours in the elderly).
Maltese: Is-CMDh innota li d-data farmakokinetika rrieżaminata matul ilproċedura tindika li l-half-life ta' hydroxyzine tidher li turi żieda lineari mal-età (il-half-life fi tfal li għandhom 12-il xahar hija 4 sigħat, meta mqabbel ma' 11-il siegħa għal tfal li għandhom 14il sena, 14-il siegħa fl-adulti u 29 siegħa fl-anzjani).
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the hydroxyzinecontaining products identified in Annex I remains favourable, subject to the agreed amendments to the product information and additional pharmacovigilance activities and additional risk minimisation measures.
Maltese: Bħala konsegwenza, il-PRAC ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti mediċinali li fihom hydroxyzine identifikati fl-Anness I jibqa' favorevoli, soġġett għall-emendi maqbula fl-informazzjoni tal-prodott u attivitajiet ta' farmakoviġilanza u miżuri ta' minimizzazzjoni tar-riskju addizzjonali.
English: Package size l t o r
Maltese: t x
English: The full EPAR for Ingelvac PCV Flex can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This summary was last updated in March 2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f᾿ Marzu 2017.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ingelvac PCV Flex on 24 May 2017.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Ingelvac PCV Flex 24/05/2017.
English: PCV2 infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin).
Maltese: L-infezzjonjiet PCV2 jistgħu jipproduċu sinjali kliniċi bħal telf fil-piż jew nuqqas ta᾿ żvilupp, limfonodi mkabbra, diffikultà fit-teħid tan-nifs, ġilda pallida u suffejra (sfurija tal-ġilda).
English: Ingelvac PCV Flex contains the active substance porcine circovirus type 2 ORF2 protein.
Maltese: Ingelvac PCV Flex fih is-sustanza attiva ċircovirus tal-ħnieżer ta' tip 2 proteina ORF2.
English: Ingelvac PCV Flex porcine circovirus type 2 vaccine
Maltese: Ingelvac PCV Flex ċircovirus tal-ħnieżer ta' tip 2 vaċċin
English: This is a summary of the European public assessment report (EPAR) for Ingelvac PCV Flex.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ingelvac PCV Flex.
English: Ingelvac PCV Flex is a vaccine.
Maltese: Ingelvac PCV Flex huwa vaċċin.
English: The trials showed that vaccination of pigs (which had no antibodies to PCV2 before vaccination) with Ingelvac PCV Flex reduced the levels of PCV2 in the blood, clinical signs of PCV2 infection, virus excreted from the nose and death rates.
Maltese: Il-provi wrew li t-tilqima tal-ħnieżer (li ma kellhomx antikorpi għal PCV2 qabel it-tilqima) b'Ingelvac PCV Flex naqqset il-livelli ta' PCV2 fid-demm, sinjali kliniċi tal-infezzjoni PCV2, vajrus eliminat mill-imnieħer u r-rati tal-mewt.
English: This medicine is the same as Ingelvac CircoFLEX, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina hija l-istess bħal Ingelvac CircoFLEX, li hija diġà awtorizzata fl-Unjoni Ewropea (UE).
English: The most common side effect with Ingelvac PCV Flex (which may affect more than 1 in 10 animals) is a mild and short lived increase in body temperature on the day of vaccination.
Maltese: L-effett sekondarju l-aktar komuni b'Ingelvac PCV Flex (li jista' jaffettwa aktar minn persuna 1 minn kull 10) huwa żieda ħafifa u li ma ddumx fit-temperatura tal-ġisem fil-jum tat-tilqima.
English: Other information about Ingelvac PCV Flex:
Maltese: Informazzjoni oħra dwar Ingelvac PCV Flex