FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take VFEND: - If you are allergic to the active ingredient voriconazole, or to sulfobutylether beta cyclodextrin sodium
Maltese: - Jekk inti allerġiku għal sustanza attiva voriconazole, jew għal sulfobutylether beta cyclodextrin sodium (elenkati f'sezzjoni 6).
English: Intravenous loading doses of 6 mg/kg IV twice daily on day 1 followed by 4 mg/kg intravenous dose twice daily and 300 mg oral tablets twice daily were evaluated in one adolescent pharmacokinetic study.
Maltese: Dożi inizjali fil-vina aktar qawwija ta' 6 mg/kg darbtejn kuljum fl-ewwel ġurnata segwiti minn doża fil-vina ta' 4 mg/kg darbtejn kuljum u pilloli li jittieħdu mil-ħalq ta' 300 mg kienu evalwati fi studju farmakokinetiku wieħed fl-adoloxxenti.
English: Excipient with known effect Each vial contains 217.6 mg sodium.
Maltese: Eċċipjent bl-effett magħruf Kull kunjett fih 217.6 mg sodju.
English: For Caucasians and Blacks the prevalence of poor metabolisers is 3-5%.
Maltese: Fil-każ tal-Kawkasi u s-Suwed il-prevalenza ta' metabolizzaturi ħżiena hija 3-5%.
English: Bioequivalence was established between the 200 mg tablet and the 40 mg/ml oral suspension when administered as a 200 mg dose.
Maltese: Kienet stabbilita bijoekwivalenza bejn il-pillola ta' 200mg u s-suspensjoni orali ta' 40mg/ml meta mogħtija bħala doża ta' 200 mg.
English: • Alfentanil and fentanyl and other short-acting opiates such as sufentanil (painkillers used for surgical procedures)
Maltese: • Warfarin u sustanzi oħra kontra l-koagulazzjoni tad-demm (e.ż., phenprocoumon,
English: When multiple doses of voriconazole are administered with high fat meals, Cmax and AUCτ are reduced by 34% and 24%, respectively.
Maltese: Meta dożi multipli ta' voriconazole jiġu mogħtija ma' ikliet b'kontenut għoli ta' xaħam, Cmax u AUC jitnaqqsu b'34% u 24%, rispettivament.
English: In the combined data from three bioequivalence studies using the powder for oral suspension formulation, treatment-related taste perversion was recorded in 12 (14%) of subjects.
Maltese: Fid-dejta kkombinata minn tliet studji ta' bijoekwivalenza fejn intużat il-formulazzjoni tat-trab għal suspensjoni orali, kienet irreġistrata perverżjoni tat-togħma relatata mat-trattament fi 12 (14%) -il suġġett.
English: 200 mg (5 ml) twice a day
Maltese: 200 mg (5 ml) kull 12il siegħa
English: Bottle outer pack and bottle label for 200 mg film-coated tablets - Pack of 2, 30, 100
Maltese: Pakkett ta' barra tal-flixkun u t-tikketta tal-flixkun għal pilloli ta' 200 mg miksijin b'rita - Pakkett ta' 2,
English: Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended when coadministered with voriconazole since methadone levels increased following coadministration of voriconazole.
Maltese: Huwa rrakkomandat monitoraġġ frekwenti għal reazzjoniiet avversi u tossiċità marbuta malmethadone, inkluż titwil tal-QTc, meta l-methadone jiġi amministrat flimkien ma' voriconazole billi llivelli tal-methadone żdiedu wara li ngħata ma' voriconazole.
English: * Primary endpoint of study ** Using a margin of 5%, non inferiority is demonstrated *** Difference in proportions, 95% CI obtained after adjustment for randomization
Maltese: * Punt tat-tmiem primarju tal-istudju ** Użu ta' marġini ta' 5%, tintwera li m'hemmx inferjorità ***Differenza fil-proporzjonijiet, 95% CI miksub wara aġġustament għall-għażla b'mod każwali
English: • Remove the bag of VFEND solvent for solution for infusion from the foil overwrap (do not use scissors or any other sharp tool).
Maltese: • Neħħi l-borża ta' VFEND solvent għal soluzzjoni għall-infużjoni mill-foil overwrap (tużax imqass jew xi ħaġa oħra li taqta').
English: No significant differences in Cmax and AUCτ were observed between healthy elderly females (≥ 65 years) and healthy young females (18-45 years).
Maltese: Ma kinux osservati differenzi sinifikanti f'Cmax u AUC bejn nisa anzjani b'saħħithom ( 65 sena) u nisa żgħażagħ b'saħħithom (18-45 sena).
English: VFEND 200 mg powder for solution for infusion
Maltese: VFEND 200 mg trab għal soluzzjoni għall-infużjoni
English: • VFEND powder for solution for infusion needs to first be reconstituted with either 19 ml of Water for Injections or 19 ml of 9 mg/ml (0.9%) Sodium Chloride for Infusion to obtain an extractable volume of 20 ml of clear concentrate containing 10 mg/ml voriconazole.
Maltese: • VFEND trab għal soluzzjoni għall-infużjoni l-ewwel irid jiġi rikostitwit bi 19-il ml Ilma għallInjezzjonijiet jew 19 ml ta' 9 mg/ml (0.9%) Sodium Chloride għall-Infużjoni sabiex jinkiseb volum li jista' jinġibed ta' 20 ml ta' konċentrat ċar li fih 10 mg/ml ta' voriconazole.
English: Therapy must be initiated with the specified loading dose regimen of either intravenous or oral VFEND to achieve plasma concentrations on Day 1 that are close to steady state.
Maltese: It-terapija trid tinbeda bl-iskema speċifikata tad-doża inizjali aktar qawwija ta' VFEND ġol-vini jew orali sabiex jinkisbu konċentrazzjonijiet tal-plasma fl-1 Jum li jkunu qrib ta' stat stabbli.
English: Efavirenz 400 mg QD, coadministered with voriconazole 200 mg BID
Maltese: Efavirenz 400 mg QD, amministrat flimkien ma' 200mg voriconazole BID
English: The modified intent-to-treat (MITT) group included 465 allogeneic HSCT recipients with 45% of patients having AML.
Maltese: Ilgrupp modifikat b'intenzjoni ta' trattament (MITT) kien jinkludi 465 riċevitur alloġeniku ta' HSCT fejn 45% tal-pazjenti kellhom AML. Mill-pazjenti kollha, 58% kienu suġġetti għal skemi ta' kundizzjonijiet majeloablattivi.
English: • The required volume of the reconstituted concentrate is then added to a recommended compatible infusion solution listed below to obtain a final VFEND solution containing 0.5 to 5 mg/ml of voriconazole.
Maltese: • Il-volum meħtieġ tal-konċentrat rikostitwit imbagħad jiġi miżjud ma' infużjoni kompatibbli rakkomandata għal infużjoni msemmija hawn isfel biex tinkiseb soluzzjoni finali ta' VFEND li jkun fiha 0.5 sa 5 mg/ml ta' voriconazole.
English: Voriconazole (N=98)
Maltese: Punti tat-tmiem tal-istudju Voriconazole (N=98)
English: Efavirenz may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 400 mg every 12 hours and the efavirenz dose is reduced by 50%, i.e. to 300 mg once daily.
Maltese: Efavirenz jista' jingħata flimkien ma' voriconazole jekk id-doża ta' manteniment b'voriconazole tiżdied għal 400 mg kull 12-il siegħa u d-doża ta' efavirenz titnaqqas b'50 %, i.e. għal 300 mg darba kuljum.
English: An impurity present in SBECD has been shown to be an alkylating mutagenic agent with evidence for carcinogenicity in rodents.
Maltese: Impurità, preżenti f'SBECD, intweriet li kienet aġent mutaġeniku alkalitiku b'evidenza għal karċinoġeniċità f'annimali gerriema.
English: • Patient Alert Card for Phototoxicity and SCC: - Reminds patients of the risk of phototoxicity and skin SCC.
Maltese: • Kartuna ta' twissijja għal-Pazjent għal Fototossiċità u SCC:
English: The breakthrough IFI rate to Day 180 and the primary endpoint of the study, which is Success at Day 180, for patients with AML and myeloablative conditioning regimens respectively, is presented in the table below:
Maltese: Ir-rata ta' IFIs li jiġu f'daqqa sa Jum 180 u l-punt tat-tmiem primarju tal-istudju, li hu Suċċess f'Jum 180, għal pazjenti b'AML u reġim kondizzjunarju majeloablattiv rispettivament, qed tiġi ppreżentata fit-tabella hawn taħt:
English: VFEND 50 mg film-coated tablets and 200 mg film-coated tablets are available as packs of 2, 10, 14, 20, 28, 30, 50, 56 and 100.
Maltese: Il-pilloli VFEND 50 mg miksijin b'rita u l-pilloli VFEND 200 mg miksijin b'rita huma disponibbli bħala pakketti ta' 2, 10, 14, 20, 28, 30, 50, 56 u 100.
English: VFEND 200 mg powder and solvent for solution for infusion Voriconazole
Maltese: VFEND 200 mg trab u solvent għal soluzzjoni għal infużjoni Voriconazole
English: VFEND 200 mg powder and solvent for solution for infusion
Maltese: VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni
English: One study enrolled 31 patients with possible, proven or probable invasive aspergillosis (IA), of whom 14 patients had proven or probable IA and were included in the MITT efficacy analyses.
Maltese: Studju wieħed kellu rreġistrati fi ħdanu 31 pazjent b'asperġillożi invażiva (IA - invasive aspergillosis) possibbli, ipprovata jew probabbli, li minnhom, 14-il pazjent kellhom IA ipprovata jew probabbli u ġew inklużi fl-analiżi taleffikaċja tal-MITT.
English: Bottle outer pack and bottle label for 50 mg film-coated tablets - Pack of 2, 30, 100
Maltese: Pakkett ta' barra tal-flixkun u t-tikketta tal-flixkun għal pilloli ta' 50 mg miksijin b'rita - Pakkett ta' 2,
English: 7a Attach the IV line to the patient injection site.
Maltese: 3a Neħħi l-qoxra tal-adattatur tal-kunjett u armiha.
English: Inflammation of the sinuses, inflammation of the gums, chills, weakness Low numbers of some types, including severe, of red (sometimes immune-related) and/or white blood cells (sometimes with fever), low numbers of cells called platelets that help the blood to clot Low blood sugar, low blood potassium, low sodium in the blood Anxiety, depression, confusion, agitation, inability to sleep, hallucinations Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness Bleeding in the eye
Maltese: Infjammazjoni tas-sinus, infjammazzjoni tal-ħanek, kesħa, indeboliment - Ammonti baxxi ta' xi tipi, inkluż severi, ta' ċelloli tad-demm ħomor (xi kultant relatati malimmunità) u/jew bojod (xi kultant bid-deni), ammonti baxxi ta' ċelluli msejħa pjastrini li jgħinu lid-demm biex jagħqad - Livell baxx ta' zokkor fid-demm, livell baxx ta' potassium fid-demm, livell baxx ta' sodium fiddemm - Ansjetà, depressjoni, konfużjoni, aġitazzjoni, ma tkunx tista' torqod, alluċinazzjonijiet - Aċċessjonijiet, rogħda jew movimenti tal-muskoli mhux ikkontrollati, tnemnim jew sensazzjonijiet mhux normali tal-ġilda, żieda fit-ton tal-muskoli, ngħas, sturdament
English: Coadministration with high-dose ritonavir (400 mg and above twice daily) because ritonavir significantly decreases plasma voriconazole concentrations in healthy subjects at this dose (see section 4.5, for lower doses see section 4.4).
Maltese: L-amministrazzjoni flimkien ma' doża għolja ta' ritonavir (400 mg u aktar darbtejn kuljum) billi ritonavir inaqqas b'mod sinifikanti l-konċentrazzjonijiet ta' voriconazole fil-plasma f'suġġetti b'saħħithom f'din id-doża (ara sezzjoni 4.5, għal dożi aktar baxxi ara sezzjoni 4.4).
English: For administration, the required volume of the reconstituted concentrate is added to a recommended compatible infusion solution (detailed in the table below) to obtain a final voriconazole solution containing 0.5-5 mg/ml.
Maltese: Biex jingħata, il-volum meħtieġ tal-konċentrat rikostitwit jiġi miżjud ma' soluzzjoni kompatibbli rakkomandata għall-infużjoni (dettaljata fit-tabella hawn isfel) biex tinkiseb soluzzjoni finali ta' voriconazole li fiha 0.5-5 mg/ml.
English: A comparison of the paediatric and adult population pharmacokinetic data indicated that the predicted total exposure (AUC) in children following administration of a 9 mg/kg IV loading dose was comparable to that in adults following a 6 mg/kg IV loading dose.
Maltese: Paragun tad-dejta farmakokinetika fit-tfal u fl-adulti indika li l-esponiment totali (AUC) mbassar fittfal wara amministrazzjoni ta' doża inizjali fil-vina aktar qawwija ta' 9 mg/kg kien kumparabbli ma' dak tal-adulti wara amministrazzjoni ta' doża inizjali fil-vina aktar qawwija ta' 6 mg/kg. Lesponimenti totali mbassra fit-tfal wara dożi ta' manteniment fil-vina ta' 4 u 8 mg/kg darbtejn kuljum kienu kumparabbli ma' dawk tal-adulti wara dożi fil-vina ta' 3 u 4 mg/kg darbtejn kuljum, rispettivament.
English: Prophylaxis should be as short as possible depending on the risk for developing invasive fungal infection (IFI) as defined by neutropenia or immunosuppression.
Maltese: Il-profilassi għandha tkun qasira kemm jista' jkun skont ir-riskju li titfaċċa infezzjoni fungali invażiva (IFI) kif definit minn newtropenija jew immunosoppressjoni.
English: The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell membrane and may be responsible for the antifungal activity of voriconazole.
Maltese: L-akkumulazzjoni tal-14 alpha-methyl sterols jirrelata mat-telf sussegwenti ta' ergosterol fil-membrana taċ-ċellola fungali u jista' jkun responsabbli għal attività antifungali ta' voriconazole.
English: The median duration of study drug prophylaxis was 95.5 days in the MITT group.
Maltese: Il-medjan tat-tul ta' żmien talprofilassi bil-mediċina tal-istudju kien ta' 95.5 jum fil-grupp MITT.
English: When voriconazole treatment is stopped, the initial dose of efavirenz should be restored (see section 4.2 and 4.4).
Maltese: Disturbi tal-elettroliti bħal ipokalimja, ipomanjesemija u ipokalċimja għandhom jiġu korretti qabel ma jinbeda t-trattament b'voriconazole (ara sezzjonijiet 4.2 u 4.4).
English: The intravenous vehicle, SBECD, is haemodialysed with a clearance of 55 ml/min.
Maltese: Il-prodott mogħti ġol-vini, SBECD, jiġi ħemodijalizzat bi tneħħija ta' 55 ml/min.
English: Inhibitors or inducers of these isoenzymes may increase or decrease voriconazole plasma concentrations, respectively, and there is potential for voriconazole to increase the plasma concentrations of substances metabolised by these CYP450 isoenzymes.
Maltese: L-inibituri u l-indutturi ta' dawn l-isoenzimi jistgħu jżidu jew inaqqsu il-konċentrazzjoni ta' voriconazole fil-plażma, rispettivament, u hemm potenzjal għal voriconazole li jżid l-konċentrazzjonijiet tas-sustanzi mmetabolizzati minn dawn l-isoenzimi talCYP450.
English: VFEND 200 mg powder and solvent for solution for infusion Powder for solution for infusion: White lyophilised powder.
Maltese: VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni Trab għal soluzzjoni għall-infużjoni:
English: Phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased from 200 mg to 400 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Maltese: Aġġustamenti fid-dożaġġ f'każ ta' għoti ta' mediċini differenti flimkien Phenytoin jista' jingħata flimkien ma' voriconazole jekk id-doża ta' manteniment ta' voriconazole tiżdied minn 200 mg għal 400 mg b'mod orali, darbtejn kuljum (bejn 100 mg u 200 mg b'mod orali, darbtejn kuljum f'pazjenti li jiżnu inqas minn 40 kg), ara sezzjonijiet 4.4 u 4.5.
English: Concomitant use of voriconazole and phenytoin should be avoided unless the benefit outweighs the risk (see section 4.5).
Maltese: L-użu f'daqqa ta' voriconazole u phenytoin għandu jiġi evitat jekk il-benefiċċju ma jkunx akbar mir-riskju (ara sezzjoni 4.5).
English: Each vial contains 200 mg voriconazole, equivalent to a 10 mg/ml solution when reconstituted as directed by your hospital pharmacist or nurse (see the information at the end of this leaflet).
Maltese: Kull kunjett fih 200 mg voriconazole, ekwivalenti għal soluzzjoni ta' 10 mg/ml meta rikostitwita kif indikat mill-ispiżjar jew infermier ta' l-isptar tiegħek (ara t-tagħrif fl-aħħar ta' dan il-fuljett).
English: The clinical efficacy data were supported by limited susceptibility data.
Maltese: Id-dejta dwar l-effikaċja klinika kienet sostnuta b'dejta limitata dwar is-suxxettibilità.
English: When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see sections 4.4 and 4.5).
Maltese: Meta t-trattament b'voriconazole titwaqqaf, id-dożaġġ inizjali ta' efavirenz għandu jkun mibdul għal li kien (ara sezzjonijiet 4.4 u 4.5).
English: Treatment of invasive aspergillosis
Maltese: Tossiċità tal-fwied
English: Hang the infusion bag.
Maltese: Pakkett issiġillat.
English: What VFEND looks like and contents of the pack VFEND powder and solvent for solution for infusion is presented as an administration kit containing:
Maltese: Id-dehra ta' VFEND u l-kontenut tal-pakkett VFEND trab u solvent għal soluzzjoni għall-infużjoni hu ppreżentat f'sett ta' amministrazzjoni li fih:
English: Content
Maltese: Kontenut (konċentrazzjoni)
English: Invented name Strength Pharmaceutical form Route of administration
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: 50 jars
Maltese: 75 mg 13C urea 50 vażett
English: EU/1/97/045/003 Helicobacter Test INFAI for children of the age 3-11
Maltese: Mnejn jingħata Il-pakkett
English: 12 x (1 vial + 1 prefilled syringe + 1 vial adapter with needle + 2 alcohol wipes) (Titration pack)
Maltese: 12 x (kunjett 1 + siringa mimlija għal-lest 1 + adattatur għall-kunjett b'labra 1 + 2 imsielaħ bl-alkoħol) (Pakkett ta' titrazzjoni)
English: MA (EU) number (Invented) name
Maltese: Numru tal-EU (MA)
English: Ifirmasta irbesartan
Maltese: irbesartan
English: Ifirmasta is a ‘generic medicine'.
Maltese: Ifirmasta huwa ‘mediċina ġenerika'.
English: It is available as tablets (75, 150 and 300 mg).
Maltese: Jiġi bħala pilloli (75, 150 u 300 mg).
English: The full EPAR for Ifirmasta 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 Ifirmasta:
Maltese: Informazzjoni oħra dwar Ifirmasta:
English: Ifirmasta is a medicine that contains the active substance irbesartan.
Maltese: Ifirmasta huwa mediċina li fiha s-sustanza attiva irbesartan.
English: What are the benefit and risk of Ifirmasta?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Ifirmasta?
English: This document is a summary of the European public assessment report (EPAR) for Ifirmasta.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ifirmasta.
English: The usual recommended dose of Ifirmasta is 150 mg once a day.
Maltese: Id-doża normalment rakkomandata ta' Ifirmasta hija ta' 150 mg darba kuljum.
English: The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Krka on 1 December 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Irbesartan Krka valida fl-Unjoni Ewropea kollha fl-1 ta' Diċembru 2008.
English: A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
Maltese: Doża inizjali ta' 75 mg tista' tintuża f'pazjenti li għaddejjin minn emodijaliżi (teknika ta' tisfija tad-demm) jew f'pazjenti li għandhom iktar minn 75 sena.
English: This means that Ifirmasta is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aprovel.
Maltese: Dan ifisser li Ifirmasta huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Aprovel.
English: Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
Maltese: Il-kura tinbeda b'doża ta' 150 mg darba kuljum u normalment tiżdied għal 300 mg darba kuljum.
English: The CHMP concluded that, in accordance with EU requirements, Ifirmasta has been shown to have comparable quality and to be bioequivalent to Aprovel.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Ifirmasta wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Aprovel.
English: What is Ifirmasta?
Maltese: X'inhu Ifirmasta?
English: Why has Ifirmasta been approved?
Maltese: Għaliex ġie approvat Ifirmasta?
English: How has Ifirmasta been studied?
Maltese: Kif ġie studjat Ifirmasta?
English: Because Ifirmasta is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Billi Ifirmasta huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji jitqiesu li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: The active substance in Ifirmasta, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Ifirmasta, l-irbesartan, hija ‘antagonist tar-riċetturi tal-anġjotensina
English: Because Ifirmasta is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine.
Maltese: Billi Ifirmasta huwa mediċina ġenerika, l-istudji f'pazjenti ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza.
English: Ifirmasta is used in adults who have essential hypertension (high blood pressure).
Maltese: Ifirmasta jintuża f'adulti li jkollhom ipertensjoni (pressjoni tad-demm għolja) essenzjali.
English: If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide.
Maltese: Jekk il-pressjoni taddemm ma tkunx ikkontrollata kif xieraq, id-doża tista' tiżdied għal 300 mg kuljum jew inkella jistgħu jiżdiedu mediċini oħra għall-ipertensjoni, bħall-idroklorotijażide.
English: Ifirmasta is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Maltese: Ifirmasta jintuża wkoll għall-kura ta' mard tal-kliewi f'adulti li jbatu minn ipertensjoni u dijabete tat-tip 2.
English: This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Maltese: Dan iwassal għal tnaqqis fil-pressjoni tad-demm, u b'hekk jitnaqqas ir-riskju kkawżat minn pressjoni għolja tad-demm, fosthom il-puplesija.
English: Previously known as Irbesartan Krka.
Maltese: L-EPAR sħiħ għal Ifirmista jinstab fis-sit web tal-Aġenzija:
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Maltese: L-EPAR sħiħ tal-mediċina ta' referenza jinstab ukoll fis-sit web tal-Aġenzija.
English: How is Ifirmasta used?
Maltese: Għal xiex jintuża Ifirmasta?
English: Intervet Nederland B.V. Wim de Körverstraat 35 5831 AN Boxmeer Tel: +31.485.587652
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer Tel: +31.485.587652
English: EU/2/11/122/001 bottle of 52 ml EU/2/11/122/002 bottle of 100 ml EU/2/11/122/003 bottle of 252 ml
Maltese: EU/2/11/122/001 flixkun ta' 52 ml EU/2/11/122/002 flixkun ta' 100 ml EU/2/11/122/003 flixkun ta' 252 ml
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati)
English: Date of first authorisation: 14/04/2011 Date of last renewal: 15/03/2016
Maltese: Data tal-ewwel awtorizzazzjoni: 14/04/2011 Data tal-aħħar tiġdid tal-awtorizzazzjoni: 15/03/2016
English: Onset of immunity:
Maltese: Tul ta' żmien tal-immunità:
English: ATCvet codes: QI04AA02 (sheep) and QI02AA08 (cattle).
Maltese: Kodiċijiet vet ATC: QI04AA02 (ngħaġ) u QI02AA08 (frat).
English: ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle).
Maltese: QI04AA02 (ngħaġ) u QI02AA08 (frat).
English: (*) equivalent to titre prior to inactivation (log10)
Maltese: (*) ekwivalenti għal titrazzjoni qabel l-inattivazzjoni (log10)
English: BLUEVAC BTV8 stimulates active immunity against bluetongue virus, serotype 8.
Maltese: BLUEVAC BTV8 jistimula l-immunità attiva kontra l-virus tal-Bluetongue, serotip 8
English: Each ml of vaccine contains: BTV8 antigen 106.5 CCID50
Maltese: Antiġen ta' BTV8 106.5