FrancophonIA/ELRC3.0 huggingface dataset:
English: Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section “Warnings and precautions”):
Maltese: Dawn huma s-sinjali ta' ketoaċidożi tad-dijabete (ara wkoll is-sezzjoni “Twissijiet u prekawzjonijiet”):
English: Patients were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo administered once daily in addition to continuation of background metformin therapy (see Table 2).
Maltese: Il-pazjenti ntagħżlu b'mod arbitrarju biex jingħataw ertugliflozin 5 mg, ertugliflozin 15-il mg, jew plaċebo darba kuljum flimkien mat-tkomplija tat-terapija fl-isfond b'metformin (ara Tabella 2).
English: In the rat fertility and embryonic development study, male and female rats were administered ertugliflozin at 5, 25, and 250 mg/kg/day.
Maltese: Fl-istudju dwar il-fertilità u l-iżvilupp tal-embriju fil-far, firien irġiel u nisa ngħataw ertugliflozin biddożi ta' 5, 25, u 250 mg/kg/jum.
English: Each tablet contains 2.5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Maltese: Kull pillola fiha 2.5 mg ta' ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 850 mg ta' metformin hydrochloride.
English: Similarly, there was no tumorigenic potential observed with metformin in male rats.
Maltese: B'mod simili, ma kien osservat l-ebda potenzjal tumoriġeniku b'metformin f'firien irġiel.
English: Alternative methods should be used to monitor glycaemic control.
Maltese: Għandhom jinużaw metodi alternattivi biex jiġi mmonitorjat ilkontroll gliċemiku.
English: At usual clinical doses and dosing schedules of metformin hydrochloride tablets, steadystate plasma concentrations of metformin are reached within 24-48 hours and are generally <1 µg/ml.
Maltese: Bid-dożi u l-iskedi tad-dożi kliniċi tas-soltu ta' pilloli metformin hydrochloride, ilkonċentrazzjonijiet fi stat fiss ta' metformin fil-plażma jintlaħqu fi żmien 24-48 siegħa u b'mod ġenerali jkunu <1 μg/mL.
English: Segluromet 7.5 mg/850 mg film-coated tablets
Maltese: Segluromet 7.5 mg/850 mg pilloli miksija b'rita
English: Limited data from controlled pharmacokinetic studies of metformin in healthy elderly subjects suggest that total plasma clearance of metformin is decreased, the half-life is prolonged, and Cmax is increased, compared to healthy young subjects.
Maltese: Data limitata minn studji farmakokinetiċi kkontrollati ta' metformin f'individwi anzjani f'saħħithom tissuġġerixxi li t-tneħħija totali ta' metformin mill-plażma tonqos, il-half-life titwal, u s-Cmax tiżdied, meta mqabbla ma' individwi żgħażagħ f'saħħithom.
English: Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
Maltese: Segluromet huwa indikat fl-adulti li għandhom 18-il sena u aktar b'dijabete mellitus tat-tip 2 bħala żieda mad-dieta u mal-eżerċizzju biex itejjeb il-kontroll gliċemiku:
English: Baseline (mean) Change from baseline (LS mean Difference from Sitagliptin Ertugliflozin 5 mg Ertugliflozin 15 mg (LS mean
Maltese: Sejbiet neoplastiċi marbuta ma' ertugliflozin kienu jinkludu żieda fl-inċidenza ta' feokromoċitoma beninna fil-medulla tal-glandoli adrenali fil-firien irġiel bid-doża ta' 15-il mg/kg/jum.
English: During controlled clinical trials of metformin, maximum metformin plasma levels did not exceed 5 µg/mL, even at maximum doses.
Maltese: Waqt provi kliniċi kkontrollati ta' metformin, l-ogħla livelli ta' metformin fil-plażma ma qabżux il-5 µg/mL, anke bl-ogħla dożi.
English: Consideration may also be given to stopping treatment with ertugliflozin/metformin in patients who develop events which may precede amputation such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene.
Maltese: Għandu jitqies ukoll ittwaqqif tat-trattament b'ertugliflozin/metformin f'pazjenti li jiżviluppaw avvenimenti li jistgħu jiġu qabel amputazzjoni bħal ulċera fil-ġilda, infezzjoni, osteomijelite jew kankrena fir-riġel.
English: The mean systemic plasma clearance following an intravenous 100 µg dose was 11 l/hr.
Maltese: Il-medja tat-tneħħija sistemika mill-plażma wara doża ta' 100 µg fil-vini kienet 11-il l/siegħa.
English: Segluromet 2.5 mg/850 mg film-coated tablets
Maltese: Segluromet 2.5 mg/850 mg pilloli miksija b'rita
English: Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Maltese: Sintomi gastrointestinali bħal nawsja, rimettar, dijarea, uġigħ fl-addome u telf t'aptit iseħħu l-aktar frekwenti waqt il-bidu tat-terapija u fil-biċċa l-kbira tal-każijiet jgħaddu b'mod spontanju.
English: Fournier's gangrene has to be treated immediately.
Maltese: Il-kankrena ta' Fournier trid tiġi ttrattata immedjatament.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kondizzjoni ma kinitx tipika b'żieda moderata biss ta' inqas minn 14-il mmol/l (250 mg/dl) fil-valuri tal-glucose fid-demm.
English: Patients were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo administered once daily in addition to continuation of background metformin and sitagliptin therapy (see Table 4).
Maltese: Il-pazjenti ntagħżlu b'mod arbitrarju biex jirċievu ertugliflozin 5 mg, ertugliflozin 15-il mg, jew plaċebo darba kuljum flimkien mat-tkomplija tat-terapija fl-isfond b'metformin u sitagliptin (ara Tabella 4).
English: Reproductive system and breast disorders Common
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Komuni
English: Ertugliflozin may add to the diuretic effect of diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Maltese: Ertugliflozin jista' jżid mal-effett dijuretiku tad-dijuretiċi u jista' jżid ir-riskju ta' deidratazzjoni u pressjoni baxxa (ara sezzjoni 4.4).
English: • Metformin works by inhibiting sugar (glucose) production in the liver.
Maltese: • Metformin jaħdem billi jinibixxi l-produzzjoni taz-zokkor (glucose) fil-fwied.
English: Table 5: Results at Week 52 from an active-controlled study comparing ertugliflozin to glimepiride as add-on therapy in patients inadequately controlled on metformin*
Maltese: Riżultati f'Ġimgħa 52 minn studju kkontrollat b'mod attiv li qabbel ertugliflozin ma' glimepiride bħala terapija miżjuda f'pazjenti li ma kinux ikkontrollati b'mod adegwat b'metformin*
English: Each tablet contains 7.5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Maltese: Kull pillola fiha 7.5 mg ta' ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 850 mg ta' metformin hydrochloride.
English: Includes: pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia.
Maltese: ¶ Tinkludi: pollakijurja, urġenza biex tagħmel l-awrina, polijurja, żieda fl-ammont tal-awrina li tagħmel, u awrina bil-lejl. #
English: Interference with 1,5 anhydroglucitol (1,5-AG) assay Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycaemic control in patients taking medicines containing an SGLT2 inhibitor.
Maltese: Il-monitoraġġ tal-kontroll gliċemiku b'analiżi ta' 1,5-AG mhuwiex rakkomandat minħabba li l-kejl ta' 1,5-AG mhuwiex affidabbli għall-istima tal-kontroll gliċemiku f'pazjenti li jkunu qed jieħdu mediċini li jkun fihom inibitur ta' SGLT2.
English: With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.
Maltese: B'terapija b'metformin, it-tnixxija tal-insulina ma tinbidilx filwaqt li l-livelli tal-insulina waqt is-sawm u r-rispons tal-insulina fil-plażma matul il-jum jistgħu fil-fatt jonqsu.
English: The impact of UGT inhibitors on the pharmacokinetics of ertugliflozin has not been studied clinically, but potential increase in ertugliflozin exposure due to UGT inhibition is not considered to be clinically relevant.
Maltese: L-impatt ta' inibituri ta' UGT fuq il-farmakokinetika ta' ertugliflozin ma ġiex studjat b'mod kliniku, iżda ż-żieda possibbli fl-esponiment għal ertugliflozin minħabba inibizzjoni ta' UGT mhijiex ikkunsidrata li tkun rilevanti b'mod kliniku.
English: Hepatic impairment
Maltese: Effett tossiku ġenerali
English: For patients switching from separate tablets of ertugliflozin and metformin Patients switching from separate tablets of ertugliflozin (5 mg or 15 mg total daily dose) and metformin to Segluromet should receive the same daily dose of ertugliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
Maltese: Pazjenti li se jibdlu minn għoti ta' pilloli separati ta' ertugliflozin (doża totali ta' 5 mg jew 15-il mg kuljum) u metformin għal Segluromet għandhom jirċievu l-istess doża ta' kuljum ta' ertugliflozin u metformin li tkun diġà qed tittieħed jew l-eqreb doża terapewtika xierqa ta' metformin.
English: Moderate hepatic impairment (based on the Child-Pugh classification) did not result in an increase in exposure of ertugliflozin.
Maltese: Indeboliment moderat tal-fwied (abbażi tal-klassifikazzjoni ta' Child-Pugh) ma wassalx għal żieda flesponiment għal ertugliflozin.
English: Epivir lamivudine
Maltese: Epivir lamivudina
English: The full EPAR for Epivir 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: This summary was last updated in 02-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'02-2015.
English: It is available as tablets (150 and 300 mg) and as an oral solution (10 mg/ml).
Maltese: Jiġi bħala pilloli (150 mg u 300 mg) u bħala soluzzjoni orali (10 mg/ml).
English: The most common side effects with Epivir (seen in between 1 and 10 patients in 100) are diarrhoea, nausea (feeling sick), vomiting, headache, insomnia (difficulty sleeping), cough, nasal symptoms, rash, muscle disorders, arthralgia (joint pain), alopecia (hair loss), fever, abdominal pain (stomach ache) or cramps, malaise (feeling unwell) and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Epivir (li dehru f'bejn pazjent 1 u 10 minn 100) huma dijarrea, nawżja (dardir), remettar, uġigħ ta' ras, insonnja (diffikultà fl-irqad), sogħla, sintomi nażali, raxx, disturbi tal-muskoli, artralġija (uġigħ fil-ġogi), alopeċja (telf ta' xagħar), deni, uġigħ (uġigħ fl-istonku) jew brim addominali, tħossok ma' tiflaħx u għeja kbira.
English: Epivir is a medicine containing the active substance lamivudine.
Maltese: Epivir huwa mediċina li fiha s-sustanza attiva lamivudina.
English: In the fifth adult study, adding Epivir to existing treatment reduced the risk of disease progression or death: after a year, 9% of the patients taking Epivir had developed an AIDS-related illness or died (128 out of 1,369), compared with 20% of those taking placebo (95 out of 471).
Maltese: Fil-ħames studju fuq adulti, iż-żieda ta' Epivir ma' kura eżistenti naqqset ir-riskju tal-progressjoni talmarda jew il-mewt: wara sena, 9% tal-pazjenti li kienu qed jieħdu Epivir kienu żviluppaw marda relatata mal-AIDS jew mietu (128 minn 1,369), meta mqabbla ma' 20% ta' dawk li ħadu l-plaċebo (95 minn 471).
English: This document is a summary of the European Public Assessment Report (EPAR) for Epivir.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Epivir.
English: Other information about Epivir
Maltese: Aktar informazzjoni dwar Epivir
English: The recommended dose of Epivir for adults and children weighing at least 25 kg is 300 mg a day.
Maltese: Id-doża rakkomandata ta' Epivir għal adulti u tfal li jiżnu mill-inqas 25 kg hija 300 mg kuljum.
English: Epivir is used in combination with other antiviral medicines to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Epivir jintuża flimkien ma' mediċini antivirali oħra għall-kura ta' pazjenti infettati bil-virus talimmunodefiċjenza umana (HIV), il-virus li jikkawża s-sindromu tad-defiċenza immunitarja akkwiżita (AIDS).
English: What is the risk associated with Epivir?
Maltese: X'inhu r-riskju assoċjat ma' Epivir?
English: What is Epivir?
Maltese: X'inhu Epivir?
English: The studies examined the effects of Epivir on the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count).
Maltese: L-istudji eżaminaw l-effetti ta' Epivir fuq il-livelli ta' HIV fid-demm (tagħbija virali) u l-għadd ta' ċelloli-CD4 T fid-demm (għadd taċ-ċelloli CD4).
English: Why has Epivir been approved?
Maltese: Għaliex ġie approvat Epivir?
English: Epivir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Epivir, meħud f'kombinazzjoni ma' mediċini antivirali oħra, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: The active substance in Epivir, lamivudine, is a nucleoside reverse transcriptase inhibitor (NRTI).It works by blocking the activity of reverse transcriptase, an enzyme needed by HIV to produce the genetic instructions for making more viruses once it has infected the cell.
Maltese: Is-sustanza attiva f'Epivir,il-lamivudina, hija inibitur nukleosidiku tat-transkrittażi inversa (NRTI).
English: The study compared the effects of Epivir taken with zidovudine to didanosine (another antiviral medicine) taken alone.
Maltese: L-istudju qabbel l-effetti ta' Epivir meħud flimkien ma' żidovudina, ma' didanosina (mediċina antivirali oħra) meħud waħdu.
English: Four of these studies compared Epivir in combination with zidovudine (another antiviral medicine) to either Epivir or zidovudine alone, or to the combination of Epivir and zalcitabine (another antiviral medicine).
Maltese: Erbgħa minn dawn l-istudji qabblu Epivir f'kombinazzjoni ma' żidovudina (mediċina antivirali oħra) ma' jew Epivir jew żidovudina waħdu, jew il-kombinazzjoni ta' Epivir u żalċitabina (mediċina antivirali oħra).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Epivir on 8 August 1996.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Epivir fit-8 ta' Awwissu 1996.
English: In children weighing less than 25 kg the recommended dose depends on their weight.
Maltese: Fi tfal li jiżnu inqas minn 25 kg id-doża rakkomandata tiddependi mill-piż tal-ġisem.
English: A risk management plan has been developed to ensure that Epivir is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Epivir jintuża bl-aktar mod sigur possibbli.
English: Epivir has also been studied in 615 patients aged between nine months and 15 years.
Maltese: Epivir ġie studjat ukoll f'615-il pazjent li kellhom bejn disa' xhur u 15-il sena.
English: CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Maltese: Iċ-ċelloli-CD4 T huma ċelloli tad-demm bojod li huma importanti fil-ġlieda kontra l-infezzjonijiet, iżda li jinqatlu bl-HIV.
English: Epivir has been studied in five main studies involving almost 3,000 adults (aged 18 years or over).
Maltese: Epivir ġie studjat f'ħames studji ewlenin li kienu jinvolvu kważi 3,000 adult (minn 18-il sena 'l fuq).
English: The dose of Epivir needs to be adjusted in patients who have severe kidney problems.
Maltese: Id-doża ta' Epivir għandha tiġi aġġustata f'pazjenti li għandhom problemi renali gravi.
English: In the first four studies in adults, Epivir, taken in combination with zidovudine, increased CD4 cell counts more than the comparator medicines after 24 weeks of treatment.
Maltese: Fl-ewwel erba' studji fuq adulti, Epivir, meħud flimkien ma' żidovudina, żied l-għadd ta' ċelloli CD4 aktar mill-mediċini tat-tqabbil wara kura ta' 24 ġimgħa.
English: This can be taken either as a single daily dose or divided into 150 mg twice a day.
Maltese: Din tista' tittieħed bħala doża unika ta' kuljum jew maqsuma f' 150 mg darbtejn kuljum.
English: 50 doses (50 ml)
Maltese: 50 doża (50 ml)
English: Laboratory of Lyon Porte des Alpes Rue de l'Aviation,
Maltese: Laboratorju ta' Lyon Porte des Alpes Rue de l'Aviation
English: Silicon antifoam Phosphate buffer Glycine buffer
Maltese: Silicon antifoam Buffer ta' fosfat Buffer ta' glycine
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of the first authorisation: 17/12/2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17/12/2010
English: PACKAGE SIZE 100 doses (100 ml)
Maltese: DAQS TAL-PAKKETT 100 doża (100 ml)
English: Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code QI04AA02 (sheep) and QI02AA08 (cattle).
Maltese: Grupp Farmako-terapewtiku: vaċċin kontra l-virus tal-Bluetongue, Kodici ATC veterinarja Q104AA02 (nagħaġ) u Q102AA08 (baqar).
English: Store and transport refrigerated (2 °C-8 °C).
Maltese: Aħżen u ttrasporta fil-friġġ (2 °C-8 °C)
English: Al3+ (as hydroxide)
Maltese: (bħala hydroxide)
English: EU/2/10/112/001 EU/2/10/112/002 EU/2/10/112/003 EU/2/10/112/004 EU/2/10/112/005
Maltese: EU/2/10/112/001 EU/2/10/112/002 EU/2/10/112/003 EU/2/10/112/004
English: EU/2/10/112/005 EU/2/10/112/003 EU/2/10/112/004 EU/2/10/112/001 EU/2/10/112/002
Maltese: EU/2/10/112/005 EU/2/10/112/003 EU/2/10/112/004
English: The vaccine contains inactivated Bluetongue Virus Serotype 1 with aluminium hydroxide and saponin adjuvants.
Maltese: Il-vaċċin fih il-virus tal-Bluetongue serotip 1 inattivat, bl-adjuvanti aluminju hydroxide u saponin.
English: In very rare cases it has been observed a transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Maltese: F'każi rari ħafna ġiet osservata żieda temporaneja fit-temperatura tal-ġisem, normalment ta' mhux iżjed minn medja ta' 1.1 °C, fi żmien 24 siegħa wara t-tilqim.
English: Date of the last renewal:
Maltese: Data tal-aħħar tiġdid:
English: Box of 10 bottles of 100 ml
Maltese: Kaxxa ta'10 fliexken ta' 100 ml
English: Do not freeze.
Maltese: Nagħaġ u baqar.
English: Inactivated BTV1 ..................................................................................................... ≥ 1.9 log10 pixels* Aluminium hydroxide, Saponin, qs 1 dose (*) (*) see package leaflet
Maltese: BTV1 inattivat ........................................................................................................ ≥ 1.9 log10 pixels * Aluminium hydroxide, Saponin, qs doża waħda (*)
English: Type I glass bottle of 10 ml with butyl elastomere closure Box of 1 bottle of 10 doses (1 x 10 ml)
Maltese: Flixkun tal-ħġieġ tat-Tip I ta' 10 ml b'tapp tal-butyl elastomere Kaxxa ta' flixkun ta' 10 dożi (1 x 10 ml)
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Maltese: Is-sustanzi mhux attivi,(inklużi l-adjuvanti), elenkati f'sezzjoni 6.1 tal-SPC huma jew sustanzi permessi li għalihom tabella 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Numru 37/2010 tindika li l-ebda MRL mhu meħtieġ.
English: (**) Haemolytic units For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva, peress li hija kostitwent ta' oriġini bioloġika intiża biex tipproduċi immunità attiva, mhix fl-ambitu tar-Regolament (KE)Numru 470/2009.
English: 1 bottle of 10 doses (1x 10 ml) 1 bottle of 50 doses (1 x 50 ml) 10 bottles of 50 doses (10 x 50 ml) 1 bottle of 100 doses (1 x 100 ml) 10 bottles of 100 doses (10 x 100 ml)
Maltese: Flixkun ta' 10 doża (1 x 10 ml) Flixkun ta' 50 doża (1 x 50 ml) 10 fliexken ta' 50 dożi (10 x 50 ml) Flixkun ta' 100 doża (1 x 100 ml) 10 fliexken ta' 100 doża (10 x 100 ml)
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated BTV 1 ...................................................................................................... ≥ 1.9 log10 pixels
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI BTV1 inattivat ............................................................................................................ ≥ 1.9 log10 pixels
English: Box of 10 bottles of 50 ml,
Maltese: Flixkun ta' 10 u 50 ml
English: Detailed information of this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Inactivated Bluetongue Virus Serotype 1 ................................................................. ≥ 1.9 log10 pixels* (*) Antigen content (VP2 protein) by immuno-assay Adjuvants: .
Maltese: Serotip 1 tal-virus inattivat tal-Bluetongue ........................................................... ≥ 1.9 log10 pixels*
English: It induces an active and specific immunity against Bluetongue Virus Serotype 1 in the vaccinated animal.
Maltese: Jinduċi immunita' attiva u speċifika kontra s-serotip 1 tal-virus tal-bluetongue fl-annimal imlaqqam.
English: Veterinary medicinal product subject to prescription.
Maltese: Tħallat ma' ebda prodott mediċinali veterinarju ieħor.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 1 suspension for injection for sheep and cattle
Maltese: VETERINARJU BTVPUR AlSap 1 suspensjoni għal injezzjoni għan-nagħaġ u l-baqar
English: The manufacture, import, possession sale, supply and/or use of BTVPUR AlSap 1 may be prohibited in a Member State on the whole or part of their territory pursuant to national legislation.
Maltese: Il-manifattura, -l-importazzjoni, il-pussess, bejgħ, provista u / jew l-użu ta' BTVPUR AlSap 1 jistgħu jkunu pprojbiti f'ċertu Stat Membru jew ġo parti mit-Territorju tiegħu minħabba l-leġiżlazzjoni nazzjonali.
English: - 2nd injection: after 3-4 weeks
Maltese: - It-tieni injezzjoni: wara 3-4 ġimgħat
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 doses (10 ml)
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 10 dożi (10 ml)
English: *(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission).
Maltese: Immunizzazzjoni attiva ta' nagħaġ u baqar għall-prevenzjoni tal-viremia* u għat-tnaqqis ta' sinjali kliniċi kkawżati mis-serotip 1 tal-virus tal-bluetongue. *(taħt il-livell ta' detection bil-metodu validat RT-PCR ta' 3.68 log10 RNA kopji/ml, li jindika li ma kienx hemm trażmissjoni ta' virus infettiv).
English: Not all pack sizes may be marketed Box of 1 bottle of 10 doses (1 x 10 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml) Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml)
Maltese: Kaxxa ta' flixkun ta' 10 dożi (1 x 10 ml) Kaxxa ta' flixkun ta' 50 doża (1 x 50 ml) Kaxxa ta' 10 fliexken ta' 50 doża (10 x 50 ml) Kaxxa ta' flixkun ta' 100 doża (1 x 100 ml) Kaxxa ta' 10 fliexken ta' 100 doża (10 x 100 ml)