FrancophonIA/ELRC3.0 huggingface dataset:
English: Through a pronounced reduction of bleeding, reducing anaemia and related symptoms, Esmya has been demonstrated to rapidly contribute to the improvement of the quality of life in patients who did not undertake a surgical treatment.
Maltese: Permezz ta' tnaqqis evidenti ta' fsada, tnaqqis ta' anemija u sintomi relatati, Esmya ntwera li jikkontribwixxi malajr għat-titjib tal-kwalità tal-ħajja f'pazjenti li ma sarilhomx kura kirurġika.
English: The PRAC considers that in vitro studies should be performed by the MAH, in order to better characterize the mechanistic profile of DILI as associated with Esmya.
Maltese: Il-PRAC jikkunsidra li l-MAH għandu jwettaq studji in vitro, sabiex jiġi kkaratterizzat aħjar il-profil mekkanistiku ta' DILI kif assoċjat ma' Esmya.
English: Emtriva emtricitabine
Maltese: Emtriva emtriċitabina
English: The full EPAR for Emtriva 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: Other information about Emtriva:
Maltese: Informazzjoni oħra dwar Emtriva:
English: The active substance in Emtriva, emtricitabine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Maltese: Is-sustanza attiva f'Emtriva, l-emtriċitabina, hija inibitur nukleosidiku tat-transkrittażi inversa (nucleoside reverse transcriptase inhibitor - (NRTI)).
English: The usual dose of oral solution is 6 mg per kilogram body weight once a day, up to a maximum of 240 mg (24 ml).
Maltese: Id-doża normali ta' soluzzjoni orali hija 6 mg għal kull kilogramm ta' piż tal-ġisem darba kuljum, sa massimu ta' 240 mg (24 ml).
English: Emtriva is an antiviral medicine for treating adults and children infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Emtriva huwa mediċina antivirali li tintuża biex tikkura adulti u tfal infettati bil-virus talimmunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu tal-immunodefiċjenza akkwiżita (AIDS).
English: This is a summary of the European public assessment report (EPAR) for Emtriva.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Emtriva.
English: This difference was maintained after 48 weeks of treatment (73% and 56%).
Maltese: Din id-differenza nżammet wara 48 ġimgħa ta' kura (73% u 56%).
English: • In a third study in 459 patients who had been taking three antiviral medicines (including lamivudine), the number of patients switching from lamivudine to Emtriva who had viral loads below 400 copies/ml after 48 weeks was similar to the number of those who continued taking lamivudine (73% and 82%, respectively).
Maltese: • Fit-tielet studju f'459 pazjent li kienu qed jieħdu tliet mediċini antivirali (inkluż lamivudina), lgħadd ta' pazjenti li qalbu minn lamivudina għal Emtriva li kellhom tagħbijiet virali taħt 400 kopja/ml wara 48 ġimgħa kien simili għall-għadd ta' dawk li komplew jieħdu lamivudina (73% u 82%, rispettivament).
English: Emtriva is available as capsules (200 mg) and as a solution (10 mg/ml) to be taken by mouth.
Maltese: Emtriva jiġi bħala kapsuli (200 mg) u bħala soluzzjoni (10 mg/ml) li tittieħed mill-ħalq.
English: Why is Emtriva approved?
Maltese: Għaliex ġie approvat Emtriva?
English: • In a study of 571 previously untreated adults, more patients taking Emtriva (in combination with didanosine and efavirenz) had viral loads below 50 copies/ml after 24 weeks of treatment than those taking stavudine (81% and 70%, respectively).
Maltese: • Fi studju ta' 571 adult mhux ikkurati preċedentement, aktar pazjenti li ħadu Emtriva (f'kombinazzjoni ma' didanosine u efavirenz) kellhom tagħbijiet virali taħt 50 kopja/ml wara 24 ġimgħa ta' kura minn dawk li ħadu stavudina (81% u 70%, rispettivament).
English: • In another study in 468 previously untreated patients, Emtriva was as effective as lamivudine (both taken in combination with stavudine and either efavirenz or nevirapine).
Maltese: • Fi studju ieħor f'468 pazjent mhux ikkurati preċedentement, Emtriva kien effettiv daqs lamivudina (it-tnejn meħudin f'kombinazzjoni ma' stavudina u jew efavirenz jew nevirapina).
English: Emtriva is used in combination with other antiviral medicines and contains the active substance emtricitabine.
Maltese: Emtriva jintuża f'kombinazzjoni ma' mediċini antivirali oħrajn u fih is-sustanzza attiva emtriċitabina.
English: What is the risk associated with Emtriva?
Maltese: X'inhu r-riskju assoċjat ma' Emtriva?
English: The usual dose of Emtriva is one capsule once a day for patients who weigh 33 kg or more.
Maltese: Id-doża normali ta' Emtriva hija kapsula waħda darba kuljum għal pazjenti li jiżnu 33 kg jew aktar.
English: It blocks the activity of reverse transcriptase, an enzyme made by the virus that allows it to reproduce itself in the cells it has infected.
Maltese: Din timblokka l-attività tat-transkrittażi inversa, enzima prodotta mill-virus li jippermettilha tirriproduċi lilha nnifisha fiċ-ċelloli li tkun infettat.
English: The most common side effects with Emtriva (seen in more than 1 patient in 10) are headache, diarrhoea, nausea (feeling sick), and elevated creatine kinase levels in the blood (an enzyme found in muscles).
Maltese: L-effetti sekondarji l-iktar komuni b'Emtriva (li dehru f'iktar minn pazjent 1 minn kull 10) huma wġigħ ta' ras, dijarea, nawżja (tħossok ma tiflaħx) u livelli għoljin ta' kreatina kinażi fid-demm (enzima li tinsab fil-muskoli).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emtriva on 24 October 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Emtriva fl-24 ta' Ottubru 2003.
English: Studies have shown that Emtriva, in combination with other antiviral medicines, reduces viral loads in HIV-infected patients and compares well with other medicines used in combination.
Maltese: Studji wrew li Emtriva, f'kombinazzjoni ma' mediċini antivirali oħrajn, inaqqas it-tagħbijiet virali f'pazjenti infettati bl-HIV u jitqabbel sew ma' mediċini oħrajn użati f'kombinazzjoni.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Emtriva's benefits are greater than its risks for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Emtriva huma akbar mir-riskji tiegħu għall-kura ta' adulti u tfal infettati b'HIV-1 f'kombinazzjoni ma' aġenti antiretrovirali oħrajn.
English: Similar results on effectiveness were seen in two studies involving 120 children and adolescents taking Emtriva in combination with other antiviral medicines.
Maltese: Riżultati simili dwar l-effikaċja dehru f'żewġ studji li kienu jinvolvu 120 tfal u adoloxxenti li kienu qed jieħdu Emtriva f'kombinazzjoni ma' midiċini antivirali oħrajn.
English: How does Emtriva work?
Maltese: Kif jintuża Emtriva?
English: For patients who have taken medicines to treat their HIV infection before and did not respond to that treatment, doctors should only prescribe Emtriva once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus's response to any new antiviral medicines that might be prescribed.
Maltese: Il-Kumitat innota li din l-indikazzjoni hija bbażata fuq studji f'pazjenti li ma kinux irċevew kura preċedenti kontra l-HIV, jew li l-HIV tagħhom hija diġà kkontrollata tajjeb b'mediċini antivirali, u li ma kienx hemm esperjenza li Emtriva f'pazjenti li l-kura preċedenti tagħhom kontra l-HIV ma kinitx qed taħdem.
English: How is Emtriva used?
Maltese: Kif jaħdem Emtriva?
English: The oral solution is for patients who weigh less than 33 kg, and those who cannot swallow the capsules.
Maltese: Is-soluzzjoni orali hija għal pazjenti li jiżnu inqas minn 33 kg, u għal dawk li ma jistgħux jibilgħu l-kapsuli.
English: Emtriva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Emtriva, meta jittieħed f'kombinazzjoni ma' mediċini antivirali oħrajn, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: In this study after 48 weeks, around two thirds of the patients had viral loads below 400 copies/ml, and slightly fewer had viral loads below 50 copies/ml.
Maltese: F'dan l-istudju wara 48 ġimgħa, madwar żewġ terzi tal-pazjenti kellhom tagħbijiet virali taħt 400 kopja/ml, u ftit inqas kellhom tagħbijiet virali taħt 50 kopja/ml.
English: Pharmacokinetics
Maltese: Farmakokinetiċi
English: Betavert N was approved in EU, on 18 April 2007, during a Mutual Recognition Procedure (MRP) with Germany as Reference Member State (RMS) plus 7 Concerned Member States (CMS): AT, BG, CZ, HU, PL, RO and SK.
Maltese: Betavert N kien approvat fl-UE, fit-18 ta' April 2007, waqt Proċedura ta' Rikonoxximent Reċiproku (Mutual Recognition Procedure - MRP) bil-Ġermanja bħala Stat Membru ta' Referenza (RMS) flimkien ma' 7 Stati Membri Konċernati (CMS): AT, BG, CZ, HU, PL, RO u SK.
English: Benefit Risk Assessment
Maltese: Evalwazzjoni Benefiċċju Riskju
English: Metabolism: Betahistine dihydrochloride is rapidly metabolised in the liver to the inactive major metabolite, 2-pyridylacetic acid and to demethyl-betahistine [2-(2 aminoethylpyridine)].
Maltese: Betahistine dihydrochloride huwa metabolizzat malajr fil-fwied għall-metabolit maġġuri mhux attiv, 2-pyridylacetic acid u għal demethyl-betahistine [2-(2 aminoethylpyridine)].
English: Betahistine is a structural analogue of the endogenous histamine.
Maltese: Betahistine huwa analogu strutturali tal-istamina endoġena.
English: No significant changes were observed in 6 months accelerated stability study (40°C/ 75% RH) and up to 5 years controlled room temperature stability study.
Maltese: Ma ġewx osservati bidliet sinifikanti fi studju ta' stabilità aċċelerata ta' 6 xhur (40°C/ 75% RH) u fi studju ta' stabilità b'temperatura ambjentali kkontrollata sa 5 snin.
English: The active substance Betahistine hydrochloride is described in Ph.Eur.
Maltese: Is-sustanza attiva Betahistine hydrochloride hija deskritta fil-Ph.Eur.
English: Bulgaria
Maltese: Il-Bulgarja
English: Quality aspects
Maltese: Aspetti tal-kwalità
English: Validations of the analytical methods have been presented.
Maltese: Ġew ippreżentati validazzjonijiet tal-metodi analitiċi.
English: The MAH has provided documents that set out a detailed description of the system of pharmacovigilance.
Maltese: Il-MAH ipprovda dokumenti li jistabbilixxu deskrizzjoni dettaljata tas-sistema ta' farmakoviġilanza.
English: The Marketing Authorisation Holder of Betavert N is Hennig Arzneimittel GmbH & Co.KG
Maltese: Il-Ġermanja HENNIG ARZNEIMITTEL GmbH & Co.
English: The Marketing Authorisation Holder of the originator is Solvay Pharma B.V. settled in Netherlands.
Maltese: Id-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq (MAH) tal-oriġinatur huwa Solvay Pharma B.V. stabbilit fl-Olanda.
English: The CHMP concluded that betahistine dihydrochloride can be classified as Class I according to Biopharmaceutics Classification System.
Maltese: Is-CHMP kkonkluda li betahistine dihydrochloride jista' jiġi kklassifikat bħala Klassi I skont is-Sistema ta' Klassifikazzjoni tal-Bijofarmaċewtiċi.
English: This procedure concerns Betavert N, a generic version of betahistine dihydrochloride tablets.
Maltese: Din il-proċedura tikkonċerna Betavert N, verżjoni ġenerika ta' pilloli ta' betahistine dihydrochloride.
English: Strength
Maltese: KG
English: The determination of 2-Pyridylacetic acid (PAA), the active metabolite of betahistine, from urine samples was not considered as up-to-date method, the measurement of PAA in human plasmas would have considered more appropriate.
Maltese: Id-determinazzjoni ta' 2-Pyridylacetic acid (PAA), il-metabolit attiv ta' betahistine, minn kampjuni tal-awrina ma kinitx ikkunsidrata bħala metodu aġġornat, il-kejl ta' PAA fil-plażma umana kien ikun ikkunsidrat aktar xieraq.
English: (Invented) Name
Maltese: Id-Detentur tal
English: The MAH has demonstrated that Betavert N (Hennig Arzneimittel GmbH, Germany) and the originator, Betaserc® 8 (Duphar, UK), are bioequivalent after single administration.
Maltese: Il-MAH wera li Betavert N (Hennig Arzneimittel GmbH, il-Ġermanja) u l-oriġinatur, Betaserc® 8 (Duphar, Renju Unit), huma bijoekwivalenti wara għotja waħda.
English: The CHMP agreed that there were no objections to approval of Betavert N 8 mg and Betavert N 16 mg from a nonclinical point of view.
Maltese: Is-CHMP qabel li ma kien hemm l-ebda oġġezzjoni għall-approvazzjoni ta' Betavert N 8 mg u Betavert N 16 mg minn lat mhux kliniku.
English: Based on these, the CHMP proposed a re-test period of 5 years for betahistine hydrochloride.
Maltese: Abbażi ta' dawn, is-CHMP ppropona perijodu ta' prova mill-ġdid ta' 5 snin għal betahistine hydrochloride.
English: The binding of Betahistine to human plasma proteins has been measured by equilibrium dialysis.
Maltese: It-twaħħil ta' Betahistine mal-proteini tal-plażma uman tkejjel permezz ta' dijaliżi ta' ekwilibriju.
English: The BCS-studies of betahistine substance and formulations presented herein along with the properties of the drug substance (therapeutic index, safety and complete absorption) and the formulations (composition) provided robust support for waiving in vivo BE studies for Betavert N. Moreover, betahistine fulfils the regulatory requirements for granting a biowaver, being assigned to the group of compounds with high solubility and complete absorption - accordant with Class I of BCS.
Maltese: Barra minn hekk, betahistine jissodisfa r-rekwiżiti regolatorji għall-għoti ta' biowaver, minħabba li huwa kklassifikat filgrupp ta' komposti b'solubbiltà għolja u assorbiment totali - b'konformità ma' Klassi I ta' BCS.
English: The issue was referred to the CMD(h) and an assessment was carried out by the RMS.
Maltese: Il-kwistjoni ġiet riferuta lis-CMD(h) u l-RMS wettaq evalwazzjoni.
English: The CHMP considered the chemicalpharmaceutical documentation and Expert Report, of Betahistine, of sufficient quality in view of the present European regulatory requirements.
Maltese: Is-CHMP qies id-dokumentazzjoni kimika-farmaċewtika u r-Rapport tal-Esperti, ta' Betahistine, ta' kwalità adegwata meta wieħed jikkunsidra r-rekwiżiti regolatorji Ewropej preżenti.
English: The MAH demonstrated the bioequivalence with two types of data: an in vivo BE-study (bioequivalence study) with urine measurement and in vitro studies on BA/BE based on Biopharmaceutics Classification System (BCS).
Maltese: Il-MAH wera l-bijoekwivalenza permezz ta' żewġ tipi ta' dejta: studju BE (studju ta' bijoekwivalenza) invivo bil-kejl tal-awrina u studji invitro dwar BA/BE ibbażati fuq is-Sistema ta' Klassifikazzjoni talBijofarmaċewtiċi (Biopharmaceutics Classification System - BCS).
English: The conditions for the suitability of this biowaiver have been discussed taking into account: solubility, dissolution, and absorption/permeability.
Maltese: Il-kundizzjonijiet għall-konvenjenza ta' dan il-biowaiver ġew diskussi filwaqt li ġew ikkunsidrati: is-solubbiltà, it-taħlil, u l-assorbiment/il-permeabilità.
English: This was done by a bioequivalence study investigating urine levels of the main metabolite and by supportive in vitro studies, performed in the course of the national authorisation procedure, leading to the conclusion that it is justified to waive for further bioequivalence studies in human volunteers.
Maltese: Dan sar permezz ta' studju ta' bijoekwivalenza li investiga l-livelli ta' awrina tal-metabolit ewlieni u permezz ta' studji ta' appoġġ in vitro, imwettqa matul ilproċedura tal-awtorizzazzjoni nazzjonali, li wasslu għall-konklużjoni li r-rinunzja għal aktar studji ta' bijoekwivalenza fil-volontiera umani hija ġġustifikata.
English: The evaluation of the permeability and the absorption of the active substance was derived from a bioequivalence and a mass balance study in vivo.
Maltese: L-evalwazzjoni tal-permeabilità u l-assorbiment tas-sustanza attiva saret minn studju ta' bijoekwivalenza u ta' bilanċ tal-massa in vivo.
English: Peak plasma concentrations of C14-labelled betahistine dihydrochloride are reached approximately 1 hour after oral administration in fasting volunteers.
Maltese: Ilkonċentrazzjonijiet massimi ta' plażma ta' betahistine dihydrochloride tikkettjat C14 jintlaħqu bejn wieħed u ieħor siegħa wara l-għotja orali f'volontiera sajmin.
English: The bioequivalence between Betavert N and the originator is based on Biopharmaceutics Classification System (BCS) approach (biowaiver).
Maltese: Il-bijoekwivalenza bejn Betavert N u l-oriġinatur hija bbażata fuq l-approċċ (biowaiver) tas- Sistema ta' Klassifikazzjoni tal-Bijofarmaċewtiċi (BCS).
English: Betahistine is an analogue of histamine, which is indicated in the treatment of vertigo associated with functional disorders of the vestibular apparatus in the context of Meniere's symptom complex.
Maltese: Betahistine huwa analogu tal-istamina, li huwa indikat fil-kura tal-isturdament assoċjat ma' disturbi filfunzjoni tal-apparat vestibulari fil-kuntest tal-kumpless tas-sintomi ta' Meniere.
English: The Benefit-Risk-Assessment is positive.
Maltese: L-Evalwazzjoni Benefiċċju-Riskji hija waħda pożittiva.
English: Distribution: The human volume of distribution of betahistine dihydrochloride is not known.
Maltese: Il-volum uman ta' distribuzzjoni ta' betahistine dihydrochloride mhuwiex magħruf.
English: The RMS considers that the Pharmacovigilance system as described by the MAH fulfils the requirements as described in Volume 9A of the Rules Governing Medicinal Products in the European Union and provides adequate evidence that the MAH has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country.
Maltese: L-RMS jikkunsidra li s-sistema ta' Farmakoviġilanza kif deskritta mill-MAH tissodisfa r-rekwiżiti kif deskritti fil-Volum 9A tar-Regoli li Jirregolaw il-Prodotti Mediċinali fl-Unjoni Ewropea u tipprovdi prova adegwata li l-MAH għandu s-servizzi ta' persuna kwalifikata responsabbli għall-farmakoviġilanza u għandu l-mezzi meħtieġa għan-notifika ta' kwalunkwe reazzjoni avversa suspettata li tista' sseħħ kemm filKomunità kif ukoll f'pajjiż terz.
English: The CHMP, considered these data, concluded that betahistine dihydrochloride can be assigned to the highly soluble class according to Biopharmaceutics Classification System, Class I.
Maltese: Is-CHMP, ikkunsidra dawn id-dejta u kkonkluda li betahistine dihydrochloride jista' jitpoġġa fil-klassi b'solubbiltà għolja skont is-Sistema ta' Klassifikazzjoni tal-Bijofarmaċewtiċi, Klassi I.
English: Human plasma protein binding is under 5%.
Maltese: It-twaħħil mal-proteina tal-plażma huwa taħt il-5%.
English: Elimination: Excretion of Betahistine is almost entirely (85 % - 90 %) in the urine within 24 hours Betahistin is excreted almost completely as the major metabolite in the urine.
Maltese: It-tneħħija ta' Betahistine issir kważi kollha (85 % - 90 %) fl-awrina fi żmien 24 siegħa Betahistin jitneħħa kważi kollu bħala l-metabolit maġġuri fl-awrina.
English: Germany HENNIG ARZNEIMITTEL GmbH & Co. KG
Maltese: GmbH & Co.
English: Drug substance
Maltese: Sustanza tal-mediċina
English: A statement signed by the MAH and the qualified person for pharmacovigilance, indicating that the MAH has the services of a qualified person responsible for pharmacovigilance and the necessary means for the notification of any adverse reaction occurring either in the Community or in a third country has been provided.
Maltese: Ġiet ipprovduta dikjarazzjoni ffirmata mil-MAH u l-persuna kwalifikata għall-farmakoviġilanza, li tindika li lMAH għandu s-servizzi ta' persuna kwalifikata responsabbli għall-farmakoviġilanza u l-mezzi meħtieġa għan-notifika ta' kwalunkwe reazzjoni avversa li tista' sseħħ kemm fil-Komunità kif ukoll f'pajjiż terz.
English: The absolute bioavailability of betahistine dihydrochloride is not known.
Maltese: Il-bijodisponibbiltà assoluta ta' betahistine dihydrochloride mhijiex magħrufa.
English: Consequently the drug product is eligible for BCS based biowaiver approach.
Maltese: Għaldaqstant il-prodott mediċinali huwa eliġibbli għal approċċ biowaiver ibbażat fuq il-BCS.
English: Absorption: following oral administration, betahistine dihydrochloride is rapidly and completely absorbed.
Maltese: Assorbiment: wara għotja orali, betahistine dihydrochloride jiġi assorbit b'mod mgħaġġel u b'mod sħiħ.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION
Maltese: RAĠUNIJIET GĦAL OPINJONI POŻITTIVA
English: Comprimate
Maltese: Distribuzzjoni:
English: The originator product is Betaserc® 8 available in 8 mg tablets.
Maltese: Il-prodott oriġinatur huwa Betaserc® 8 li jiġi f'pilloli ta' 8 mg.
English: Efficacy and safety of betahistine dihydrochloride in the treatment of symptoms associated with Menière's disease have been demonstrated in preclinical-and clinical trials.
Maltese: Effikaċja klinika/sigurtà L-effikaċja u s-sigurtà ta' betahistine dihydrochloride fil-kura tas-sintomi assoċjati mal-marda ta' Menière intwerew fi provi ta' qabel l-użu kliniku u ta' waqt l-użu kliniku.
English: The CHMP asked the MAH to clearly prove the bioequivalence between Betavert N and the originator.
Maltese: Betahistine dihydrochloride pur ma setax jikkwantifika b'mod affidabbli fil-ġisem tal-bniedem.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru MA (UE) Isem (ivvintat)
English: Immediate Packaging
Maltese: Għamla Farmaċewtika
English: Bovine rhinotracheitis vaccine (inactivated)
Maltese: Tilqima ta' rinotrakeite bovina (inattivata)
English: The full EPAR for Bovalto Ibraxion 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: A booster injection is given at 6 month intervals.
Maltese: Injezzjoni booster tingħata f'intervalli ta' 6 xhur.
English: Bovalto Ibraxion is an emulsion containing mineral oil.
Maltese: Bovalto Ibraxion huwa emulsjoni li fih żejt minerali.
English: This summary was last updated in August 2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Awwissu 2016.
English: This is a summary of the European public assessment report (EPAR) for Bovalto Ibraxion.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Bovalto Ibraxion.
English: The European Commission granted a marketing authorisation valid throughout the EU for Bovalto Ibraxion on 9 March 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Bovalto Ibraxion fid-9 ta' Marzu 2000.
English: Ibraxion may cause a slight rise in body temperature (less than 1°C) for less than 48 hours after injection.
Maltese: Ibraxion jista' jikkawża żieda żgħira fit-temperatura tal-ġisem (inqas minn 1°C) għal inqas minn 48 siegħa wara l-injezzjoni.
English: Bovalto Ibraxion is a veterinary vaccine used to protect cattle against infectious bovine rhinotracheitis (IBR) virus.
Maltese: Bovalto Ibraxion huwa tilqima veterinarja li tintuża biex tipproteġi lill-ifrat mill-virus ta' rinotrakeite bovina infettiva (IBR).
English: The name of the medicine was changed to Bovalto Ibraxion on 10 August 2016.
Maltese: L-isem tal-mediċina nbidel għal Bovalto Ibraxion fl-10 ta' Awwissu 2016.
English: Bovalto Ibraxion contains the active substance inactivated gene deleted IBR virus.
Maltese: Bovalto Ibraxion fih is-sustanza attiva tal-virus tal-IBR inattivat b'ġene mħassra.
English: Cattle vaccinated with Bovalto Ibraxion had protective levels of antibodies to IBR virus at 2 weeks after vaccination and the duration of protection was shown to last 6 months.
Maltese: L-ifrat li tlaqqmu b'Bovalto Ibraxion kellhom livelli protettivi ta' antikorpi għall-virus tal-IBR ġimagħtejn wara t-tilqim u deher li l-protezzjoni damet 6 xhur.