FrancophonIA/ELRC3.0 huggingface dataset:
English: Within the first 2 hours, ventricular arrhythmia occurred in 6.4 % of patients treated with vernakalant versus none after placebo.
Maltese: Fi żmien l-ewwel sagħtejn, arritmija ventrikulari seħħet f'6.4 % tal-pazjenti trattati b'vernakalant kontra x-xejn wara l-plaċebo.
English: However, in post-marketing experience rare cases of atrial flutter with 1:1 atrioventricular conduction are observed.
Maltese: Madankollu, fl-esperjenza ta' wara t-tqegħid fis-suq, ġew osservati każijiet rari ta' palpitazzjoni atrijali ma' konduzzjoni atrijuventrikulari 1:1.
English: Some patients with typical atrial flutter were included in ACT II and ACT III and vernakalant was not found to be effective in converting atrial flutter.
Maltese: Xi pazjenti b'palpitazzjoni atrijali tipika ġew inklużi f'ACT II u ACT III u vernakalant ma nstabx li kien effettiv biex jibdel il-palpitazzjoni atrijali.
English: • sneezing
Maltese: SN:
English: Cumulative doses above 565 mg have not been evaluated.
Maltese: Dożi kumulattivi 'l fuq minn 565 mg ma ġewx evalwati.
English: Uncommon: Lacrimation increased; eye irritation; visual impairment
Maltese: Mhux komuni: żieda fid-dmugħ; irritazzjoni fl-għajnejn; disturb fil-vista
English: Atrial Flutter
Maltese: Palpitazzjoni atrijali
English: • BRINAVESS should be used with caution in patients on oral AADs (class I and III), due to limited experience.
Maltese: • BRINAVESS għandu jintuża b'kawtela f'pazjenti fuq AADs orali (klassi I u III), minħabba esperjenza limitata.
English: Patients with renal impairment: No dose adjustment necessary (see section 5.2).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża (ara sezzjoni 5.2).
English: Bradycardia was observed predominantly at the time of conversion to sinus rhythm.
Maltese: Bradikardija kienet osservata l-aktar fil-ħin tal-qlib għar-ritmu sinusali.
English: • generalised itching
Maltese: • għatis
English: Clear and colourless to pale yellow solution with a pH of approximately 5.5.
Maltese: Soluzzjoni ċara u bla kulur għal safra mitfija b'pH ta' madwar 5.5.
English: If the patient was in atrial fibrillation or atrial flutter at the end of the 15-minute observation period, a second 10-minute infusion of 2.0 mg/kg BRINAVESS (or matching placebo) was administered.
Maltese: Jekk il-pazjent kien f'fibrillazzjoni atrijali jew palpitazzjoni atrijali fit-tmiem tal-perjodu ta' osservazzjoni ta' 15-il minuta, ingħatat infużjoni oħra ta' 2.0 mg/kg fuq għaxar minuti ta' BRINAVESS (jew plaċebo li jaqbel).
English: No patients with NYHA III/IV were included in the study.
Maltese: Ebda pazjent b'NYHA III/IV ma ġie inkluż fl-istudju.
English: This is equivalent to 4 % of the recommended maximum daily dietary intake for an adult.
Maltese: Dan hu ekwivalenti għal 4 % tat-teħid massimu rakkomandat ta' kuljum għal adult.
English: - Alert HCP for adverse reactions, which may occur after BRINAVESS administration, including hypotension, bradycardia, atrial flutter, or ventricular arrhythmia.
Maltese: - Wissi lill-HCP dwar reazzjonijiet avversi, li jistgħu jseħħu wara l-għoti ta' Brinavess, inkluż pressjoni baxxa, bradikardja, palpitazzjonijiet atrijali jew arrittmija ventrikulari.
English: This medicinal product contains 32 mg sodium per 200 mg vial, equivalent to 1.6 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 32 mg sodium f'kull kunjett ta' 200 ml, li skont il-WHO hu ekwivalenti għal 1.6% tat-teħid massimu rakkomandat kuljum ta' 2 g sodium għal adult .
English: Correvio Τηλ: +41 848 00 79 70
Maltese: Τηλ: +41 848 00 79 70
English: However, acute intravenous administration of vernakalant is not expected to markedly impact the PK of chronically administered 2D6 substrates, as a consequence of vernakalant's short half-life and the ensuing transient nature of 2D6 inhibition.
Maltese: Madankollu, l-għoti akut ġol-vini ta' vernakalant mhuwiex mistenni li jaffettwa b'mod sinfikanti l-PK ta' substrati 2D6 mogħtija b'mod kroniku, b'riżultat tal-half-life qasira ta' vernakalant u n-natura temporanja konsegwenti tal-inibizzjoni ta' 2D6.
English: This medicine contains 32 mg sodium (main component of cooking/table salt) in each 200 mg vial.
Maltese: Dan il-prodott mediċinali fih 32 mg sodium (komponent ewlieni tal-melħ għat-tisjir/fuq il-mejda) f'kull kunjett ta' 200 mg.
English: The relative selectivity of vernakalant on atrial versus ventricular refractoriness is postulated to result from the block of currents regulated by ion channels that are expressed in the atria, but not in the ventricles, as well as the unique electrophysiologic condition of the fibrillating atria.
Maltese: Is-selettività relattiva ta' vernakalant fuq irrefrattorjetà atrijali kontra dik ventrikolari hija postulata li tirriżulta mill-imblokk ta' kurrenti regolati b'kanali joniċi li huma espressi fl-atriji, iżda mhux fil-ventrikoli, kif ukoll il-kundizzjoni elettrofiżjoloġika unika tal-atriji li jkunu qegħdin jiffibrillaw.
English: If conversion to sinus rhythm has not occurred, the patient's vital signs and cardiac rhythm should be observed for an additional 15 minutes.
Maltese: Jekk ma jkunx hemm qlib għar-rittmu sinusali, osserva s-sinjali vitali u r-rittmu tal-qalb tal-pazjent għal 15-il minuta oħra.
English: Hypotension reported as a serious adverse experience or leading to medicinal product discontinuation occurred in CHF patients following exposure to vernakalant in 1.8 % of these patients compared to 0.3 % in placebo.
Maltese: Pressjoni baxxa rrappurtata bħala esperjenza avversa serja jew li twassal għat-twaqqif tal-prodott mediċinali rriżultat f'pazjenti CHF wara esponiment għal vernakalant fi 1.8% ta' dawn il-pazjenti meta mqabbel ma' 0.3% fi plaċebo.
English: Glucuronidation and renal excretion are the main mechanisms of elimination in CYP2D6 poor metabolisers.
Maltese: Mhux magħruf jekk vernakalant/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: Conversion of atrial fibrillation to sinus rhythm occurred rapidly (in responders the median time to conversion was 10 minutes from start of first infusion) and sinus rhythm was maintained through 24 hours (97 %).
Maltese: Il-qlib tal-fibrillazzjoni atrijali għal ritmu sinusali seħħet malajr (fil-pazjenti li rrispondew għall-kura, il-ħin medjan sal-qlib kien ta' 10 minuti mill-bidu tal-ewwel infużjoni) u rritmu sinusali nżamm sa 24 siegħa (97 %).
English: This is equivalent to 1.6 % of the recommended maximum daily dietary intake for an adult.
Maltese: Dan hu ekwivalenti għal 1.6 % tat-teħid massimu rakkomandat ta' kuljum għal adult.
English: Magyarország
Maltese: Magyarország Correvio
English: In preclinical studies, vernakalant blocks currents in all phases of the atrial action potential, including potassium currents that are expressed specifically in the atria (e.g., the ultra-rapid delayed rectifier and the acetylcholine dependent potassium currents).
Maltese: Fi studji ta' qabel l-użu kliniku, vernakalant jimblokka l-kurrenti fil-fażijiet kollha tal-potenzjal ta' azzjoni atrijali, inklużi l-kurrenti tal-potassju li huma espressi speċifikament fl-atriji (eż., ir-rettifikatur ittardjat rapidu ħafna u l-kurrenti tal-potassju dipendenti fuq l-aċitilkolina).
English: -For non-surgery patients: atrial fibrillation ≤ 7 days duration -For post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration
Maltese: Qlib malajr ta' fibrillazzjoni atrijali li ma tkunx ilha li bdiet għal ritmu sinusali fl-adulti -Għal pazjenti li ma jkunux ser jagħmlu operazzjoni: fibrillazzjoni atrijali li ddum ≤ 7 ijiem -Għal pazjenti wara operazzjoni tal-qalb: fibrillazzjoni atrijali li ddum ≤ 3 ijiem
English: • pain or numbness at the infusion site, numbness, decreased skin sensation, or tingling feelings
Maltese: • uġigħ mtarrax fis-sit tal-infużjoni, tirżiħ, sensazzjoni mnaqqsa tal-ġilda, jew sensazzjoni ta'
English: Patient selection criteria, including contraindications, special warnings and precautions for use and information about patient populations with limited information from clinical trials.
Maltese: Kriterji tal-għażla tal-pazjenti, inkluż kontraindikazzjonijiet, twissijiet speċjali u prekawzjonijiet għall-użu u informazzjoni dwar il-popolazzjonijiet tal-pazjenti b'informazzjoni limitata minn provi kliniċi
English: Do not use BRINAVESS if you take certain other intravenous medicines (antiarrhythmics Class I and III) used to normalize an abnormal heart rhythm, 4 hours before BRINAVESS is to be used.
Maltese: Tużax BRINAVESS jekk tieħu ċertu mediċini ġol vina oħrajn (antiarritmiċi ta klassi I u III) użati biex jinnormalizzaw rittmu tal-qalb mhux normali, sa 4 sigħat qabelmhu se jingħata BRINAVESS.
English: Each 10 ml vial contains 200 mg of vernakalant hydrochloride equivalent to 181 mg of vernakalant.
Maltese: Kull kunjett ta' 10 ml fih 200 mg ta' vernakalant hydrochloride ekwivalenti għal 181 mg ta' vernakalant.
English: In patients with hepatic impairment, exposures were elevated by 9 to 25 %.
Maltese: F'pazjenti b'indeboliment tal-fwied, l-espożizzjonijiet għolew b'9 sa 25%.
English: • runny nose, sore throat
Maltese: • għaraq kiesaħ, fwawar
English: Has the patient presented with an acute coronary syndrome (including myocardial infarction) in the last 30 days?
Maltese: Il-pazjent kellu sindrome akut tal-qalb (inkluż infart mijokardijaku) f'dawn l-aħħar 30 jum?
English: Key elements to be included in the educational material:
Maltese: Elementi ewlenin li għandhom jiġu inklużi fil-materjal edukattiv:
English: It will be given to you into your vein over 10 minutes.
Maltese: Huwa se jingħatalek ġewwa vina fuq perjodu ta' 10 minuti.
English: In adults it is used if you have a fast, irregular heart beat called atrial fibrillation which has started recently, less than or equivalent to 7 days, for non-surgery patients and less than or equivalent to 3 days for post-cardiac surgery patients.
Maltese: Fl-adulti jintuża jekk ikollok taħbita tal-qalb irregolari, mgħaġġla msejħa fibrillazzjoni atrijali li ma tkunx ilha li bdiet, inqas minn jew ekwivalenti għal 7 ijiem, għal pazjenti mhux kirurġiċi u inqas minn jew ekwivalenti għal 3 ijiem għal pazjenti kirurġiċi post-kardijaċi.
English: EXP Diluted solution: use within 12 hours and store at or below 25 °C.
Maltese: Soluzzjoni dilwita: uża fi żmien 12-il siegħa u aħżen f'temperatura taħt il-25 °C.
English: *The adverse reactions included in the table occurred within 24 hours of administration of vernakalant (see sections 4.2 and 5.2) with an incidence > 0.1 % of vernakalant patients and higher than placebo **see section below
Maltese: * Ir-reazzjonijiet avversi inklużi fit-tabella seħħew fi żmien 24 siegħa mill-għoti ta' vernakalant (ara sezzjonijiet 4.2 u 5.2) b'inċidenza ta' >0.
English: Vernakalant was shown to provide relief of atrial fibrillation symptoms consistent with conversion to sinus rhythm.
Maltese: Vernakalant intwera li jipprovdi solljiev mis-sintomi ta' fibrillazzjoni atrijali konsistenti ma' qlib għal ritmu sinusali.
English: Targeted effects on atrial tissue coupled with block of late sodium current suggests that vernakalant has a low proarrhythmic potential.
Maltese: L-effetti mmirati fuq it-tessut atrijali flimkien mal-imblokk ta' sodium tardiv jissuġġerixxu li vernakalant għandu potenzjal proarritmiku baxx.
English: In patients, the typical total body clearance of vernakalant was estimated to be 0.41 l/hr/kg.
Maltese: Fil-pazjenti, ittneħħija totali tipika ta' vernakalant mill-ġisem kienet stmata għal 0.41 l/siegħa/kg.
English: Vernakalant must not be administered in patients who received intravenous AADs (class I and III) within 4 hours prior to vernakalant (see section 4.3).
Maltese: Vernakalant m'għandux jingħata lil pazjenti li rċevew AADs ġol-vina (klassi I u III) sa 4 sigħat qabel ma jingħata vernakalant (ara sezzjoni 4.3).
English: Patients with CHF showed a higher overall incidence of hypotensive events, during the first 2 hours after dose in patients treated with vernakalant compared to patients receiving placebo (13.4 % versus 4.7 %, respectively).
Maltese: Pazjenti b'CHF urew inċidenza globali ogħla ta' episodji ta' pressjoni baxxa, matul l-ewwel sagħtejn wara d-doża fil-pazjenti ttrattati b'vernakalant meta mqabbla ma' pazjenti li ħadu plaċebo (13.4 % kontra 4.7 %, rispettivament).
English: This medicine contains 80 mg of sodium (main component of cooking/table salt) in each vial of 500 mg.
Maltese: Dan il-prodott mediċinali fih 80 mg ta' sodium (komponent ewlieni ta' melħ tat-tisjir/ta' fuq il-mejda) f'kull kunjett ta' 500 mg.
English: If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10-minute infusion of 226 mg (56.5 ml of 4 mg/ml solution) may be administered.
Maltese: Jekk konverżjoni għal ritmu sinusali ma jseħħx fi żmien 15-il minuta wara tmiem l-aħħar infużjoni, infużjoni oħra ta' 10 minuti ta' 226 mg (56.5 ml ta' soluzzjoni ta' 4 mg/ml) għandha tiġi amministrata.
English: This medicinal product contains 80 mg sodium per 500 mg vial, equivalent to 4 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 80 mg ta' sodium f'kull kunjett ta' 500 mg, li skont il-WHO hu ekwivalenti għal 4 % tat-teħid massimu rakkomandat kuljum ta' 2 g sodium għal adult.
English: The Marketing Authorisation Holder shall provide a check list in each pack, the text of which is included in Annex IIIA.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jipprovdi lista ta' kontroll f'kull pakkett, liema kitba hija inkluża f'Anness IIIA.
English: ACT II examined the effect of vernakalant on patients who developed atrial fibrillation of < 3 days duration after recently undergoing coronary artery bypass graft, (CABG) and/or valvular surgery (atrial fibrillation occurred more than 1 day but less than 7 days after surgery).
Maltese: ACT II eżamina l-effett ta' vernakalant fuq pazjenti li żviluppaw fibrillazzjoni atrijali li damet iżjed minn 3 ijiem wara li ftit qabel kienu għamlu coronary artery bypass graft, (CABG) u/jew operazzjoni valvulari (il-fibrillazzjoni atrijali seħħet iżjed minn jum wieħed iżda inqas minn sebat ijiem wara l-operazzjoni).
English: BRINAVESS should be administered by intravenous infusion in a monitored clinical setting appropriate for cardioversion.
Maltese: Mal-prodott mediċinali hemm ipprovdut lista ta' kontroll għal qabel l-infużjoni.
English: Common: Pruritus; hyperhidrosis Uncommon: Pruritus generalised; cold sweat
Maltese: Komuni: Pressjoni baxxa Mhux komuni: Fwawar; fwawar tal-menopawsa; sfurija ta' mard
English: Conversion of atrial fibrillation to sinus rhythm occurred rapidly (median time to conversion 12 minutes from the start of infusion).
Maltese: Il-qalba tal-fibrillazzjoni atrijali għal ritmu sinusali seħħet malajr (ħin medjan sal-qalba, 12-il minuta mill-bidu tal-infużjoni).
English: Create a solution with a concentration of 4 mg/ml following the dilution guidelines below: Patients ≤ 100 kg: 25 ml of BRINAVESS 20 mg/ml is added to 100 ml of diluent.
Maltese: Pazjenti ≤ 100 kg: 25 ml ta' BRINAVESS 20 mg/ml huma miżjudin ma' 100 ml ta' dilwent.
English: The primary endpoint was the proportion of patients that achieved sinus rhythm (SR) at 90 minutes after initiating therapy, limiting the conclusions to the effects seen in this time window.
Maltese: Il-punt ta' tmiem primarju kien il-proporzjon ta' pazjenti li kisbu ritmu sinusali (SR) 90 minuta wara l-bidu tat-terapija, li jillimita l-konklużjonijiet għall-effetti li dehru f'dan ilperjodu ta' żmien.
English: The Marketing Authorisation Holder shall ensure that all healthcare professionals (HCP) involved in the administration of BRINAVESS are provided with a healthcare professional information pack containing the following:
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura li l-Professjonisti tal-Kura tasSaħħa (HCP) kollha involuti fl-għoti ta' BRINAVESS jiġu pprovduti b'pakkett ta' informazzjoni għall-professjonisti tal-kura tas-saħħa li jkun fih dan li ġej:
English: This will be a slightly lower dose of 2 mg/kg, with a maximum calculated dose based upon 113 kg. Total doses of greater than 5 mg/kg should not be administered within 24 hours.
Maltese: Din tkun doża ftit aktar baxxa ta' 2 mg/kg b'doża massima kkalkulata bażata fuq 113 kg.
English: If haemodynamically stable atrial flutter is observed after the initial infusion, the second infusion may be administered as patients may convert to sinus rhythm (see sections 4.4 and 4.8).
Maltese: Jekk ikun osservat taħbit emodinamiku stabbli tal-atriju wara l-ewwel infużjoni, tista' tingħata t-tieni infużjoni billi l-pazjenti jistgħu jaqilbu għar-ritmu sinusali (ara ssezzjonijiet 4.4. u 4.8).
English: • Observe the patient frequently and carefully for the entire duration of the infusion and for at least 15 minutes after completion of the infusion for: o Any signs or symptoms of a sudden decrease in blood pressure or heart rate, with or without symptomatic hypotension or bradycardia o Bradycardia o Hypotension o Unexpected ECG changes (see SmPC)
Maltese: • Osserva l-pazjent ta' sikwit u b'attenzjoni matul il-ħin kollu tal-infużjoni u għal mill-inqas 15-il minuta wara li tintemm l-infużjoni għal: o Kwalunkwe sinjal jew sintomu ta' pressjoni jew rata ta' taħbit tal-qalb li titbaxxa f'daqqa,
English: • Intravenous rhythm control AADs should not be used in the first 4 hours after BRINAVESS administration.
Maltese: • AADs ta' kontroll tar-rittmu li jingħataw ġol-vina ma għandhomx jintużaw fl-ewwel 4 sigħat wara l-għoti ta' Brinavess.
English: • your heart beat (such as a very fast (uncommon) or very slow heart beat (common), a missed beat (uncommon), or a short pause in the normal activity of your heart (uncommon))
Maltese: • fit-taħbita ta' qalbek (bħal taħbit tal-qalb mgħaġġel wisq (mhux komuni) jew bil-mod wisq (komuni), titlef taħbita (mhux komuni) jew b'pawża qasira fl-attività normali ta' qalbek (mhux komuni))
English: • stuffy nose
Maltese: TWISSIJIET SPEĊJALI
English: In these studies treatment with vernakalant effectively converted atrial fibrillation to sinus rhythm as compared with placebo (see Table 2).
Maltese: F'dawn l-istudji, it-trattament b'vernakalant qaleb b'mod effettiv il-fibrillazzjoni atrijali għar-ritmu sinusali meta pparagunat malplaċebo (ara Tabella 2).
English: Your doctor will consider if you need additional rhythm control medicine 4 hours after using BRINAVESS.
Maltese: It-tabib tiegħek iqis jekk inti teħtieġx mediċina addizzjonali ta' kontroll tar-rittmu 4 sigħat wara li tuża BRINAVESS.
English: • if you take certain other intravenous medicines (antiarrhythmics Class I and III) used to normalize an abnormal heart rhythm, 4 hours before BRINAVESS is to be used
Maltese: • jekk tieħu ċerti mediċini intravenużi oħrajn (antiarritmiċi Klassi I u III) li jintużaw sabiex jinnormalizzaw rittmu tal-qalb mhux normali, 4 sigħat qabel ikun irid jintuża BRINAVESS
English: Vernakalant is extensively and rapidly distributed in the body, with a volume of distribution of approximately 2 l/kg.
Maltese: Vernakalant huwa distribwit b'mod estensiv u malajr fil-ġisem, b'volum ta' distribuzzjoni ta' madwar 2 l/kg.
English: No dose adjustment of vernakalant is required on the basis of CYP2D6 metaboliser status, or when vernakalant is administered concurrently with 2D6 inhibitors.
Maltese: M'hemmx bżonn ta' aġġustament fid-doża ta' vernakalant abbażi tal-istatus tal-metabolizzaturi ta' CYP2D6, jew meta vernakalant jingħata fl-istess ħin ma' inibituri ta' 2D6.
English: With a significantly higher conversion rate in patients treated with vernakalant, the incidence of bradycardia events was higher within the first 2 hours in vernakalant treated patients than in placebo-treated patients (1.6 % versus 0 %, respectively).
Maltese: B'rata ta' konverżjoni ferm ogħla fil-pazjenti kkurati b'vernakalant, l-inċidenza tal-episodji ta' bradikardija fl-ewwel sagħtejn kienet ogħla fil-pazjenti kkurati b'vernakalant milli fil-pazjenti kkurati bi plaċebo (1.6 % kontra 0 %, rispettivament).
English: Mechanism of action
Maltese: ACT III
English: • liver problems
Maltese: • imnieħer miżdud
English: 2800 Lyngby Denmark
Maltese: 2800 Lyngby
English: ATCvet code: QJ01FA91.
Maltese: QJ01FA91.
English: Pulmotil Tilmicosine 40 Porcins
Maltese: Pulmotil Tilmikosinae 40 Porcins
English: SPC harmonisation
Maltese: Armonizzazzjoni tal-SPC
English: Rabbits: Pasteurella multocida, Staphylococcus aureus and Bordetella bronchoseptica
Maltese: Pasteurella multocida, Staphylococcus aureus u Bordetella bronchoseptica
English: 2 kg, 5 kg and 10 kg 200g/kg: 1 kg and 10 kg
Maltese: 2 kg, 5 kg u 10 kg 200 g/kg: 1 kg u 10 kg
English: The elimination half-life was 22 hours.
Maltese: Il-half-life ta' eliminazzjoni kienet ta' 22 siegħa.
English: Maximum concentrations were reached in 30 minutes, being the Cmax obtained of 0.35 µg/ml.
Maltese: Il-konċentrazzjonijiet massimi ntlaħqu fi 30 minuta, li kien is-Cmax miksub ta' 0.35 µg/ml.
English: Eli Lilly Danmark A/S Elanco Animal Health Nybrovej 110
Maltese: Id-Danimarka Eli Lilly Danmark A/S Elanco Animal Health Nybrovej 110
English: Pigs: Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae.
Maltese: Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: antibacterials for systemic use, macrolides.
Maltese: Grupp Farmakoterapewtiku: antibatteriċi għal użu sistemiku, makrolidi.
English: Rabbits: 4 days
Maltese: Fniek: 4 ijiem
English: 2 kg, 5 kg and 10 kg 100 g/kg Premix:
Maltese: 2 kg, 5 kg u 10 kg Premix ta' 100 g/kg:
English: Kg Premix/tonne feed = Dose rate (mg/kg bodyweight) x bodyweight (kg) Daily feed intake (kg) x premix strength (g/kg)
Maltese: Kg Premix/tunnellata għalf = Rata tad-doża (mg/kg piż tal-ġisem) x piż tal-ġisem (kg) Teħid tal-għalf kuljum (kg) x qawwa ta' premix (g/kg)
English: Pigs: 21 days Rabbits: 4 days
Maltese: Ħnieżer: 21 jum Fniek: 4 ijiem
English: Biotransformation: Several metabolites are formed, the predominant one being identified as T1.
Maltese: Jiffurmaw bosta metaboliti, l-aktar wieħed predominanti ġie identifikat bħala T1.
English: Pigs, Rabbits
Maltese: Ħnieżer, Fniek
English: 40 g/kg Premix:
Maltese: Premix ta' 40 g/kg:
English: Do not store above 25 °C.
Maltese: Taħżinx f'temperaturi ogħla minn 25 ºC.
English: 8-16 mg/kg bodyweight/day
Maltese: 8-16 mg/kg piż tal-ġisem/jum
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substance:
Maltese: Sustanza Attiva:
English: Quantifiable levels of tilmicosin were found in lung tissue with the maximum concentration (1.43±1.13 µg/ml) being recorded on day 10 of medication.
Maltese: Livelli kwantifikabbli ta' tilmikosina nstabu fit-tessut tal-pulmun bl-ogħla konċentrazzjoni (1.43±1.13 µg/ml) rreġistrata fl-10 jum tat-trattament.
English: After 5 days of treatment with medicated feed at a dosage of 200 ppm of Pulmotil, tilmicosin concentrations in lung tissues were of 192 ± 103 µg/g.
Maltese: Wara 5 ijiem ta' trattament b'għalf medikat f'doża ta' 200 ppm ta' Pulmotil, il-konċentrazzjonijiet ta' tilmikosina fit-tessut tal-pulmun kienu ta' 192 ± 103 µg/g.
English: For products containing 200g tilmicosin/kg:
Maltese: Għall-prodotti li fihom 200g tilmikosina/kg:
English: 12 mg/kg bodyweight/day
Maltese: 12 mg/kg piż talġisem/jum
English: Paper/polyethylene/aluminium/polyethylene/paper bags containing 2 kg, 5 kg or 10 kg of product.
Maltese: F'boroż tal-karti/polietilene/aluminju/poliethilene/ li fihom 2 kg, 5 kg jew 10 kg ta' prodott.
English: The maximum concentration in lung tissue (2.59±1.01 µg/ml) was recorded on day 10 of medication.
Maltese: Il-konċentrazzjoni massima fittessut tal-pulmun (2.59±1.01 µg/ml) kienet irreġistrata fl-10 jum tat-trattament.
English: The CVMP has assessed for the preventive use a pilot study, four dose determination studies and 12 field trial reports.
Maltese: Is-CVMP vvaluta, għall-użu preventiv, studju pilota, erba' studji ta' determinazzjoni tad-doża u 12-il rapport ta' prova fil-prattika.