FrancophonIA/ELRC3.0 huggingface dataset:
English: HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the viral reverse transcriptase (RT).
Maltese: Ir-reżistenza ta' HIV-1 għal lamivudine tinvolvi l-iżvilupp ta' bidla fl-aċidu amino M184V qrib is-sit attiv tar- reverse transcriptase tal-virus (RT).
English: Older people: No specific data are available; however, special care is advised in this age group due to age-associated changes such as the decrease in renal function and alteration of haematological parameters.
Maltese: Ebda dejta speċifika disponibbli; madankollu, huwa rrakkomandat li tingħata kura speċjali f'dan il-grupp ta' età minħabba tibdiliet assoċjati mal-età bħat-tnaqqis fil-funzjoni talkliewi u tibdil fil-parametri ematoloġiċi.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li trażżin virali effettiv b'terapija antiretrovirali ntwera li jnaqqas b'mod sostanzjali r-riskju ta' trasmissjoni sesswali, riskju residwu ma jistax jiġi eskluż.
English: This variant arises both in vitro and in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
Maltese: Dan il-varjant joħroġ kemm in vitro kif ukoll f'pazjenti infettati bl-HIV-1 li jkunu fuq terapija antiretrovirali li jkun fiha lamivudine.
English: What Corlentor contains - The active substance is ivabradine (as hydrochloride).
Maltese: X'fih Corlentor - Is-sustanza attiva hi ivabradine (bħala hydrochloride)
English: Excipient with known effect: 63.91 mg lactose monohydrate Corlentor 7.5 mg film-coated tablets
Maltese: Eċċipjent b'effett magħruf: 63.91 mg lactose monohydrate Corlentor 7.5 mg pilloli miksija b'rita.
English: Children Corlentor is not intended for use in children and adolescents younger than 18 years.
Maltese: Corlentor mhuwiex intenzjonat sabiex jintuża fi tfal u adoloxxenti ta' inqas minn 18-il sena.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Les Laboratoires Servier
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Les Laboratoires Servier
English: Marketing Authorisation Holder: Les Laboratoires Servier 50, rue Carnot
Maltese: 50, rue Carnot
English: Corlentor 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other.
Maltese: Corlentor 7.5 mg pilloli huma pilloli miksija b'rita, kulur is-salamun, triangulari, imnaqqxin b'“7.5”
English: Corlentor 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Maltese: Corlentor 5 mg: pillola waħda miksija b'rita fiha 5 mg ivabradine (ekwivalenti għal 5.390 mg ivabradine hydrochloride)
English: Precautions for use
Maltese: Les Laboratoires Servier
English: In a 97-patient randomised placebo-controlled study, the data collected during specific ophthalmologic investigations, aiming at documenting the function of the cone and rod systems and the ascending visual pathway (i.e. electroretinogram, static and kinetic visual fields, colour vision, visual acuity), in patients treated with ivabradine for chronic stable angina pectoris over 3 years, did not show any retinal toxicity.
Maltese: Fi studju randomizzat, ta' 97 pazjent ikkontrollat bi plaċebo, id-dejta miġbura waqt investigazzjonijiet oftalmoloġiċi speċifiċi, bil-għan li jiġu ddokumentati kemm il-funzjoni ta' sistemi ta' koni u vireg kif ukoll il-passaġġ viżwali axxendentali (eż. elettroretinogramma, kampi viżivi statiċi u kinetiċi, viżjoni tal-kuluri, ċarezza tal-viżta), f'pazjenti kkurati b'ivabradine għal angina pectoris kronika stabbli fuq
English: Package leaflet: information for the patient Corlentor 5 mg film-coated tablets Corlentor 7.5 mg film-coated tablets ivabradine
Maltese: Corlentor 5 mg pilloli miksija b'rita Corlentor 7.5 mg pilloli miksija b'rita ivabradine
English: One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride)
Maltese: Pillola waħda miksija b'rita fiha 7.5 mg ivabradine (ekwivalenti ghal 8.085 mg bħala ivabradine hydrochloride)
English: Corlentor 7.5 mg film-coated tablets
Maltese: Corlentor 7.5 mg pilloli miksija b'rita.
English: Talk to your doctor or pharmacist before taking Corlentor - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
Maltese: - jekk tbati minn sintomi ta' fibrillazzjoni atrijali (rata tal-polz fi stat mistrieħ eċċezzjonalment għolja (aktar minn 110 taħbita fil-minuta) jew irregolari, mingħajr l-ebda raġuni evidenti, li jagħmilha diffiċli biex titkejjel, - jekk riċentament kellek puplesija (attakk ċerebrali), - jekk tbati ħafif għal moderat minn pressjoni baxxa, - jekk tbati minn pressjoni tad-demm mhux ikkontrollata, speċjalment wara bidla fil-kura tiegħek kontra l-pressjoni għolja, - jekk tbati minn insuffiċjenza severa tal-qalb jew kollass tal-qalb b'anormalità tal-ECG imsejħa
English: Rare: Urticaria, itching, skin reddening, feeling unwell.
Maltese: anġina eżasperata, palpitazzjonijiet, u polz irregolari).
English: Corlentor 5 mg film-coated tablets
Maltese: Corlentor 5 mg pilloli miksija b'rita.
English: Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle spasms, changes in laboratory parameters : high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision.
Maltese: ċelloli bojod tad-demm) u livell għoli ta' kreatinina fid-demm (prodott ta' tkissir tal-muskoli), raxx tal-ġilda, anġjoedema (bħal nefħa fil-wiċċ, ilsien jew griżmejn, diffikultà fit-teħid tan-nifs jew biex tibla'), pressjoni tad-demm baxxa, ħass ħażin, sensazzjoni ta' għeja, sensazzjoni ta' dgħufija, intraċċar mhux normali tal-qalb b'ECG, vista doppja, indeboliment fil-vista.
English: Salmon-coloured, triangular, film-coated tablet engraved with “7.5” on one face and on the other face.
Maltese: Pillola miksija b'rita, kulur is-salamun, triangolari, imnaqqxa b'“7.5” fuq naħa waħda u b' fuq in naħa l-oħra.
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Corlentor 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Maltese: F'xi każijiet (eż. jekk inti anzjan), it-tabib tiegħek jista' jordnalek nofs iddoża, jiġifieri nofs pillola ta' 5 mg ta' Corlentor 5 mg (li tikkorrispondi għal 2.5 mg ta' ivabradine) filgħodu u nofs pillola ta' 5 mg filgħaxija.
English: Corlentor 7.5 mg film-coated tablets EU/1/05/317/008-014
Maltese: EU/1/05/317/008-014
English: Corlentor 5 mg film-coated tablets EU/1/05/317/001-007
Maltese: EU/1/05/317/001-007
English: - if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heartbeat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
Maltese: - jekk tbati minn pressjoni baxxa ħafna; - jekk tbati minn anġina mhux stabbli (tant qawwija li l-uġigħ fis-sider ikun spiss ħafna anke meta mhemmx eżerċizzju fiżiku); - jekk tbati minn insuffiċjenza tal-qalb li dan l-aħħar marret għall-agħar; - jekk it-taħbita ta' qalbek hija imposta esklussivament mill-pacemaker tiegħek;
English: Excipients
Maltese: MEDIĊINALI
English: How to store Corlentor
Maltese: Jekk tieqaf tieħu Corlentor
English: - Hepatic impairment: in patients with mild hepatic impairment (Child Pugh score up to 7) unbound AUC of ivabradine and the main active metabolite were about 20% higher than in subjects with normal hepatic function.
Maltese: ivabradine maħlul u l-prodott attiv tal-metaboliżmu prinċipali kienu madwar 20% ogħla milli f'pazjenti fejn il-fwied kien jaħdem normali.
English: Innovation Center BioCity Nottingham Pennyfoot Street
Maltese: BioCity Nottingham Pennyfoot Street
English: HIPRA UK AND IRELAND, Ltd.
Maltese: United Kingdom HIPRA UK AND IRELAND, Ltd.
English: ATCvet code QI02AD01.
Maltese: Kodici ATC veterinarja QI02AD01
English: Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) SPAIN
Maltese: Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona)
English: Date of first authorisation: 27/01/2011 Date of last renewal: 06/11/2015
Maltese: Data tal-aħħar tiġdid: 06/11/2015
English: 5 doses 25 doses 30 doses
Maltese: 5 dożi 25 doża 30 doża
English: 7 rue Roland Garros, Batiment H 44700 - Orvault
Maltese: 7 rue Roland Garros, Batiment H
English: Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Gelatine
Maltese: Disodium phosphate dodecahydrate Potassium dihydrogen phosphate
English: Solvent: transparent homogenous liquid.
Maltese: Solvent: likwidu omoġenu trasparenti
English: Portela de Mafra e Fontaínha - Abrunheira 2665 - 191 Malveira e-mail: portugal@hipra.com
Maltese: Portugal ARBUSET, Produtos Farmacêuticos e Sanitários De Uso Animal, Lda Portela de Mafra e Fontaínha - Abrunheira 2665 - 191 Malveira e-mail: portugal@hipra.com
English: Solvent for HIPRABOVIS IBR MARKER LIVE
Maltese: Solvent għal HIPRABOVIS IBR MARKER LIVE
English: HIPRA EΛΛAΣ A.E. Ψuχάρη 3 / 184 53 Níκαια Tηλ: 210 4978660 - Fax: 210 4978661 e-mail: greece@hipra.com
Maltese: Tηλ: 210 4978660 - Fax: 210 4978661
English: HIPRA BENELUX NV Adequat Business Center Brusselsesteenweg 159 9090 Melle e-mail: benelux@hipra.com
Maltese: België/Belgique/Belgien HIPRA BENELUX NV Adequat Business Center Brusselsesteenweg 159 9090 Melle e-mail: benelux@hipra.com
English: - 02 51 80 77 91 Fax - 02 51 8082 20 e-mail: france@hipra.com
Maltese: 44700 - Orvault Tél. - 02 51 80 77 91 Fax - 02 51 8082 20
English: Pharmacotherapeutic group: Live viral vaccines, bovine rhinotracheitis virus (IBR).
Maltese: Vaċċini bovini virali ħajjin, virus bovin rhinotracheitis (IBR).
English: Monosodium glutamate Sodium chloride
Maltese: Monosodium glutamate Sodium chloride Potassium chloride Sucrose
English: HIPRA DEUTSCHLAND GmbH Münsterstraße 306
Maltese: Münsterstraße 306
English: Cattle (calves and adult cows).
Maltese: Frat (għoġġiela u baqar adulti).
English: Abbreviations: gE-: deleted glycoprotein E; tk-: deleted thymidine kinase; CCID: cell culture infectious dose
Maltese: gE-: glycoprotein E mneħħi; tk-: thymidine kinase mneħħi;CCID: cell culture infectious dose (doża infettiva ta' kultura ta'
English: Suspension after reconstitution: transparent pinkish liquid.
Maltese: Sospensjoni wara rikostituzzjoni: likwidu roża trasparenti.
English: Solvent: Colourless type I glass bottle (10 ml) or Type II glass bottle (50 ml or 100 ml containing 60 ml of solvent) or PET bottles (10, 50 or 100 ml containing 60 ml of solvent) closed with a bromobutyl rubber closure and an aluminium cap.
Maltese: Flixkun tal-ħġieġ Tip I bla kulur (10 ml) jew flixkun tal-ħġieġ Tip II (50 ml jew 100 ml li fih 60 ml ta' solvent) jew fliexken PET (10, 50 jew 100 ml li fih 60 ml ta' solvent) magħluq b'tapp talgomma tal-bromobutyl u b'kappa tal-aluminju.
English: To stimulate active immunity against bovine herpesvirus type 1 (BoHV-1) in cattle.
Maltese: Biex tistimula l-immunità attiva kontra ħerpesvirus bovin tip 1 (BoHV-1) fil-frat.
English: EU/2/10/114/001 EU/2/10/114/002
Maltese: EU/2/10/114/002
English: 4.6 Adverse reactions (frequency and seriousness)
Maltese: 4.6 Effetti mhux mixtieqa (frekwenza u gravità) Reazzjonijiet avversi komuni:
English: Ul.
Maltese: Tel.
English: Batch {number}
Maltese: Jiskadi {xahar / sena}
English: Solvent: Phosphate buffer solution.
Maltese: Soluzzjoni buffer tal-fosfati.
English: Solvent of 5 and 25 doses: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C) Solvent ta' 5 u 25 doża: Aħżen u ttrasporta ġo friġġ (2°C - 8°C) Solvent ta' 30 doża:
English: Lyophilisate for suspension for injection.
Maltese: Lijofiliżat għal sospensjoni għal injezzjoni.
English: Live gE- tk- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 106.3 - 107.3
Maltese: Virus tal-Ħerpes tal-Bovini ħaj tip 1 (BoHV-1) gE- tk- bil-ġene mneħħi darbtejn, speċi CEDDEL: 106.3
English: The solvent should be allowed to warm to a temperature between 15 ºC and 20 ºC before reconstitution of the lyophilisate.
Maltese: Is-solvent għandu jitħalla jisħon għal temperatura ta' bejn 15 ºC u 20ºC qabel rikostituzzjoni tal-lijofiliżat.
English: Cardboard box containing 1 bottle with 25 doses lyophilisate and 1 bottle with 50 ml of solvent.
Maltese: Kaxxa tal-kartuna li fiha flixkun 1 b'25 doża ta' lijofiliżat u flixkun 1 b'50 ml ta' solvent.
English: The method of administration is by intramuscular route, in the neck muscles.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu intramuskolari.
English: The manufacture, import, possession, sale, supply and/or use of HIPRABOVIS IBR MARKER LIVE may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: Il-manifattura, l-importazzjoni, il-pussess, il-bejgħ, il-provvista u/jew l-użu ta' HIPRABOVIS IBR MARKER LIVE jista' jkun ipprojbit f'ċertu Stat Membru fit-territorju kollu tiegħu jew f'parti minnu taħt leġiżlazzjoni nazzjonali.
English: Commonly, an increase in rectal temperature up to 1.63 ºC in adult cows and up to 2.18 ºC in calves may be observed.
Maltese: Komunament, tista' tiġi osservata żieda fit-temperatura tar-rektum b'sa 1.63 ºC fil-baqar adulti u b'sa 2.18 ºC fl-għoġġiela.
English: This slight swelling lasts for less than 24 hours in most cases.
Maltese: F'ħafna mill-każi, din in-nefħa ħafifa ddum għal inqas minn 24 siegħa.
English: Each dose of 2 ml: Live gE- tk- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 106.3 - 107.3 CCID50.
Maltese: Għal kull doża ta' 2 ml: Virus tal-Ħerpes tal-Bovini ħaj gE- tk- bil-ġene mneħħi darbtejn tip 1 (BoHV1), speċi CEDDEL: 106.3 - 107.3 CCID50.
English: Animals exposed to gE surface protein will test positive (i.e. cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines) but unexposed animals will test negative (i.e. non-infected animals, including those vaccinated with HIPRABOVIS IBR MARKER LIVE).
Maltese: Annimali esposti għal proteina tal-wiċċ gE jittestjaw pożittiv (jiġifieri frat infettati b'virus tal-għalqa BoHV-1 jew imlaqqmin b'vaċċini BoHV-1 mhux markaturi konvenzjonali) iżda annimali mhux esposti jittestjaw negattiv (jiġifieri annimali mhux infettati, inkluż dawk imlaqqmin b'Markatur IBR talHiprabovis Ħaj).
English: Each dose of 2 ml contains: Lyophilisate:
Maltese: Kull doża ta‘ 2 ml fiha:
English: Each dose of 2 ml contains: Live gE- tk- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 106.3 - 107.3 CCID50.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Għal kull doża ta' 2 ml: Virus tal-Ħerpes tal-Bovini ħaj tip 1 (BoHV-1) gE- tk- bil-ġene mneħħi darbtejn, speċi CEDDEL: 106.3 - 107.3 CCID50.
English: The absence of the gene coding for the gE surface protein entails that the vaccine does not elicit antibodies to glycoprotein E of BoHV-1 (marker vaccine).
Maltese: In-nuqqas tal-kodifikazzjoni tal-ġene għall-proteina tal-wiċċ gE ifisser li l-vaċċin ma jislitx antikorpi għall-glikoproteina E ta' BoHV-1 (vaċċin markatur).
English: Vaccination might very rarely cause hypersensitivity reactions.
Maltese: It-tilqima tista', rari ħafna, tikkawża reazzjonijiet ta' sensittività eċċessiva.
English: Animals vaccinated with HIPRABOVIS IBR MARKER LIVE will test positive (alongside cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines) when samples are analysed in tests based on the identification of antibodies to any other BoHV-1 antigens.
Maltese: Annimali mlaqqmin b'Markatur IBR tal-Hiprabovis ħaj jittestjaw pożittiv (flimkien ma' frat infettati bil-virus tal-għalqa ta' BoHV-1 jew imlaqqmin b'vaċċini BoHV-1 mhux markaturi konvenzjonali) meta jiġu analizzati kampjuni f'testijiet ibbażati fuq l-identifikazzjoni ta' antikorpi għal xi antiġeni oħrajn tal-BoHV-1.
English: HIPRABOVIS IBR MARKER LIVE lyophilisate for suspension for injection for cattle.
Maltese: VETERINARJU HIPRABOVIS IBR MARKER LIVE lijofiliżat għal sospensjoni għal injezzjoni.
English: Cardboard box containing 1 bottle with 5 doses of lyophilisate and 1 bottle with 10 ml of solvent.
Maltese: Kaxxa tal-kartuna li fiha flixkun 1 b'5 dożi ta' lijofiliżat u flixkun 1 b'10 ml ta' solvent.
English: The injections should be preferably administered on the alternate sides of the neck.
Maltese: L-injezzjonijiet għandhom preferibbilment jingħataw fuq in-naħat alternati tal-għonq.
English: Name and address of the manufacturer responsible for batch release Laboratorios Hipra, S.A.
Maltese: Isem u indirizz tal-manifattur(i) responsabbli mill-ħruġ tal-lott. Laboratorios Hipra S.A.
English: HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection.
Maltese: HIPRABOVIS IBR MARKER LIVE lijofiliżat u solvent għal sospensjoni għal injezzjoni.
English: Lyophilisate and solvent for suspension for injection.
Maltese: Lijofiliżat u solvent għal sospensjoni għal injezzjoni.
English: Cattle from the age of 3 months onwards.
Maltese: U METODU TA' AMMINISTRAZZJONI Frat mill-età ta' 3 xhur 'il quddiem.
English: Lyophilisate: Colourless type I glass bottle closed with a bromobutyl rubber closure and an aluminium cap.
Maltese: Flixkun tal-ħġieġ Tip I bla kulur b'tapp tal-gomma tal-bromobutyl u b'kappa tal-aluminju.
English: Cardboard box containing 1 bottle with 60 ml of solvent.
Maltese: Kaxxa tal-kartuna li fiha flixkun 1 bi 30 doża ta' lijofiliżat Kaxxa tal-kartuna li fiha flixkun 1 b'60 ml ta' solvent.
English: This enables discrimination between cattle vaccinated with this vaccine and cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines.
Maltese: Dan jippermetti li ssir diskriminazzjoni bejn frat imlaqqmin b'dan il-vaċċin u frat infettati bil-virus talgħalqa BoHV-1 jew imlaqqmin b'vaċċini BoHV-1 mhux markaturi konvenzjonali.
English: For the active immunisation of cattle from 3 months of age against bovine herpes virus type 1 (BoHV-1) to reduce the clinical signs of Infectious bovine rhinotracheitis (IBR) and field virus excretion.
Maltese: Għall-immunizzazzjoni attiva ta' frat minn età ta' tliet xhur kontra Virus tal-Ħerpes tal-Bovini tip 1 (BoHV-1) sabiex tnaqqas is-sinjali kliniċi ta' rinotrakeite tal-bovini li tittieħed (IBR) u x-xħit tal-virus fl-għelieqi
English: HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection for cattle.
Maltese: VETERINARJU HIPRABOVIS IBR MARKER LIVE lijofiliżat u solvent għal sospensjoni għal injezzjoni għal frat.
English: A slight increase in body temperature up to 1 °C is common within 4 days following vaccination.
Maltese: Żieda ħafifa fit-temperatura tal-ġisem b'sa 1°C hija komuni fi żmien 4 ijiem wara t-tilqima.
English: The vaccine contains a BoHV-1 strain (CEDDEL strain) that is double deleted within the genes coding for the gE surface protein and the tk enzyme.
Maltese: Il-vaċċin fih speċi ta' BoHV-1 (speċi CEDDEL) li hija mneħħija darbtejn fi ħdan il-kodifikazzjoni tal-ġeni għall-proteina tal-wiċċ gE u l-enzim tk.
English: The tk deletion is related to reduced viral neurotropism and reduced establishment of latency.
Maltese: Evita lintroduzzjoni ta' kontaminazzjoni matul ir-rikostituzzjoni u l-użu.
English: A transient inflammation at the inoculation site is common in cattle within 72 hours post-vaccination.
Maltese: Infjammazzjoni temporanja fis-sit tal-inokulazzjoni hija komuni fi frat fi żmien 72 siegħa wara ttilqima.
English: Vaccinated animals can be differentiated from field virus infected animals due to the marker deletion (gE-) by means of commercial diagnostic kits, unless the animals were previously vaccinated with a conventional vaccine or infected with field virus.
Maltese: Annimali mlaqqmin jistgħu jintgħarfu minn annimali infettati minn virus tal-għalqa permezz tattneħħija tal-markatur (gE-) permezz ta' kits dijanjostiċi kummerċjali, sakemm l-annimali ma jkunux ġew imlaqqmin b'vaċċin konvenzjonali jew infettati b'virus tal-għalqa.
English: Administer one dose of 2 ml by intramuscular injection in the neck muscles.
Maltese: Id-doża inizjali rakkomandata hija injezzjoni 1 ta' 2 ml tal-vaċċin rikostitwit għal kull annimal.
English: EMA/32703/2016 EMEA/H/C/000984
Maltese: EMA/32703/2016 EMA/H/C/000984
English: The full EPAR for Efient 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: It is available as tablets (5 and 10 mg).
Maltese: Jiġi bħala pilloli (5 u 10 mg).
English: The patients were followed up for an average of 14.5 months.
Maltese: Il-pazjenti ġew segwiti sa medja ta' 14.5 xhur.
English: The active substance in Efient, prasugrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Efient, il-prasugrel, hija inibitur tal-aggregazzjoni tal-pjastrini.
English: Efient is a medicine that contains the active substance prasugrel.
Maltese: Efient huwa mediċina li fiha s-sustanza attiva prasugrel.
English: This is a summary of the European public assessment report (EPAR) for Efient.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Efient.
English: The most common side effects with Efient (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haematoma (a collection of blood under the skin or in a muscle), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), rash, haematuria (blood in the urine), bleeding from needle puncture sites, haematoma at puncture sites and bruising.
Maltese: L-effetti sekondarji l-aktar komuni b'Efient (li dehru f'bejn pazjent 1 u 10 minn kull 100) huma anemija (għadd baxx ta' ċelloli tad-demm ħomor), ematoma (ġbir ta' demm taħt il-ġilda jew f'muskolu), epistassi (fsada mill-imnieħer), emorraġija gastrointestinali (fsada fl-istonku jew fl-intestini), raxx, ematurja (demm fl-awrina), fsada mill-partijiet fejn ikun sar xi titqib, ematoma u tbenġil fil-postijiet fejn ikun sar xi titqib.