FrancophonIA/ELRC3.0 huggingface dataset:
English: Sevelamer carbonate is not absorbed and may affect the bioavailability of other medicinal products.
Maltese: Bijodisponibilità Sevelamer carbonate mhijiex sustanza li tiġi assorbita u tista' taffettwa l-bijodisponibilità ta' prodotti mediċinali oħra.
English: Titration increases/decreases
Maltese: Żidiet/tnaqqis fit-tittrazzjoni
English: The recommended starting dose of sevelamer carbonate for adults is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level.
Maltese: Id-doża rakkomandata tal-bidu ta' sevelamer carbonate għall-adulti hi ta' 2.4 g jew 4.8 g kuljum skont ilħtiġijiet kliniċi u l-livell ta' fosforu fis-serum.
English: Sevelamer contains multiple amines separated by one carbon from the polymer backbone which become protonated in the stomach.
Maltese: Sevelamer fih diversi ammini multipli separati b'karbonju wieħed fis-sinsla ta' polimer li jiġu protonati fl-istonku.
English: Sevelamer carbonate is not indicated for the control of hyperparathyroidism.
Maltese: Sevelamer carbonate mhix indikata għal kontroll ta' iperparatajrojdiżmu.
English: Excipients This medicine contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn mmol 1 ta' sodium (23 mg) għal kull pillola jiġifieri tista' tgħid li huwa prattikament ‘mingħajr sodium'.
English: In patients with secondary hyperparathyroidism sevelamer carbonate should be used within the context of a multiple therapeutic approach, which could include calcium as supplements, 1,25 - dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
Maltese: F'pazjenti b'ipertajrojdiżmu sekondarju sevelamer carbonate għandha tintuża fi ħdan il-kuntest ta' approċċ terapewtiku multiplu, li jista' jinkludi l-kalċju bħala suppliment, 1,25 - dihydroxy Vitamina D3 jew wieħed mill-analogi tagħha sabiex jitnaqqas il-livelli ta' ormon paratirojde intatt (iPTH).
English: EU/1/09/521/002 180 (6 bottles of 30) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/521/002 180 (6 fliexken ta' 30) pillola miksija b'rita
English: In patients with secondary hyperparathyroidism sevelamer carbonate should be used within the context of a multiple therapeutic approach, which could include calcium as supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
Maltese: F'pazjenti b'ipertajrojdiżmu sekondarju sevelamer carbonate għandha tintuża fi ħdan il-kuntest ta' approċċ terapewtiku multiplu, li jista' jinkludi l-kalċju bħala suppliment, 1,25-dihydroxy Vitamina D3 jew wieħed mill-analogi tagħha sabiex jitnaqqas il-livelli ta' ormon paratirojde intatt (iPTH).
English: Sevelamer carbonate treatment should be reevaluated in patients who develop severe gastrointestinal symptoms.
Maltese: It-trattament b'sevelamer carbonate għandu jerġa' jiġi evalwat f'pazjenti li jiżviluppaw sintomi gastrointestinali severi.
English: Excipients This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn mmol 1 ta' sodium (23 mg) għal kull pillola jiġifieri tista' tgħid li prattikament ‘mingħajr sodium'.
English: In two randomised, cross over clinical trials, sevelamer carbonate has been shown to be therapeutically equivalent to sevelamer hydrochloride and therefore effective in controlling serum phosphorus in CKD patients on haemodialysis.
Maltese: Dawn urew ukoll li sevelamer carbonate fiż-żewġ formulazzjonijiet ta' pillola u trab huwa terapewtikament ekwivalenti għal sevelamer hydrochloride.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON with Blue Box - MULTIPACK OF 180 (6 BOTTLES OF 30) TABLETS
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA bil-Kaxxa l-Blu - PAKKETT MULTIPLU TA' 180 (6 FLIEXKEN TA' 30) PILLOLA
English: EMA/563874/2016 EMEA/V/C/004239
Maltese: EMA/563874/2016
English: Further information on Eravac can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/eravac.
Maltese: Aktar informazzjoni dwar Eravac tinstab fuq is-sit web tal-Aġenzija: ema.europa.eu/medicines/veterinary/EPAR/eravac.
English: Eravac received a marketing authorisation valid throughout the EU for Eravac on 22 September 2016.
Maltese: Eravac ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-22 ta' Settembru 2016.
English: In a later laboratory study involving 48 rabbits, 95% of Eravac vaccinated rabbits survived, compared to 65% of rabbits given placebo, following artificial infection with RHDV2 at 12 months after vaccination.
Maltese: Fi studju fil-laboratorju aktar tard li involva 48 fenek, 95 % tal-fniek imlaqqma b'Eravac baqgħu ħajjin, meta mqabbla ma' 65 % tal-fniek li ngħataw plaċebo, wara infezzjoni artifiċjali bl-RHDV2 12-il xahar wara t-tilqima.
English: Eravac is a vaccine.
Maltese: Eravac huwa vaċċin.
English: Eravac contains inactivated rabbit haemorrhagic disease type 2 virus, strain V-1037, as the active substance.
Maltese: Eravac fih il-virus tal-marda emorraġika tal-fniek tat-tip 2 inattivat, razza V-1037, bħala s-sustanza attiva.
English: What are the risks associated with Eravac?
Maltese: X'inhuma r-riskji assoċjati ma' Eravac?
English: This summary was last updated in December 2019.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Diċembru 2019.
English: The effectiveness of the vaccine was initially compared with that of a placebo (dummy) vaccine in three laboratory studies involving 301 rabbits.
Maltese: L-effikaċja tal-vaċċin fil-bidu tqabblet ma' dik ta' vaċċin plaċebo (fint) fi tliet studji fil-laboratorju li involvew 301 fenek.
English: RHD type 2 virus differs from the classic form of RHD virus since the course of disease is more prolonged, death occurs later and over a longer period and is more severe in young rabbits.
Maltese: Il-virus RHD tat-tip 2 huwa differenti mill-forma klassika tal-virus RHD minħabba li l-kors tal-marda huwa aktar fit-tul, il-mewt isseħħ aktar tard u fuq perjodu itwal u huwa aktar sever fil-fniek żgħar.
English: Eravac contains rabbit haemorrhagic disease type 2 virus (RHDV2) strain V-1037, which has been inactivated so it cannot cause the disease.
Maltese: Eravac fih il-virus tal-marda emorraġika talfniek tat-tip 2 (RHDV2), razza V-1037, li ġie inattivat sabiex ma jikkawżax il-marda.
English: The most common side effects with Eravac (which may affect more than 1 in 10 rabbits) are a shortlived increase in body temperature to slightly above 40 ºC, which may occur between two or three days after vaccination, and nodules or swellings (less than 2 cm in size) at the injection site.
Maltese: L-effetti sekondarji l-aktar komuni b'Eravac (li jistgħu jaffettwaw aktar minn fenek 1 minn kull 10 fniek) huma żieda għal perjodu qasir fit-temperatura tal-ġisem għal ftit aktar minn 40 ºC, li tista' sseħħ bejn jumejn jew tlett ijiem wara t-tilqim, u noduli jew nefħiet (inqas minn 2 cm fid-daqs) fis-sit tal-injezzjoni.
English: How does Eravac work?
Maltese: Informazzjoni oħra dwar Eravac?
English: In the second study survival of Eravac-vaccinated rabbits was 93% compared with 50% for rabbits given placebo.
Maltese: Fit-tieni studju s-sopravivenza tal-fniek imlaqqma b'Eravac kienet ta' 93 % meta mqabbla ma' 50 % għallfniek li ngħataw il-plaċebo.
English: Eravac (rabbit haemorrhagic disease vaccine, inactivated)
Maltese: Eravac fih aġġuvant (żejt minerali) biex itejjeb ir-rispons immunitarju.
English: In one study all Eravac-vaccinated rabbits survived, compared with a 37% survival rate in the group that received the placebo vaccine.
Maltese: Fi studju wieħed il-fniek kollha mlaqqma b'Eravac baqgħu ħajjin, meta mqabbla mar-rata ta' sopravivenza ta' 37 % fil-grupp li rċieva l-vaċċin plaċebo.
English: Eravac is a veterinary vaccine used in rabbits to reduce death due to the rabbit haemorrhagic disease (RHD), caused by the variant of RHD virus called RHD type 2 (RHDV2).
Maltese: Eravac huwa vaċċin veterinarju li jintuża fil-fniek sabiex inaqqas il-mewt minħabba l-marda emorraġika tal-fniek (RHD), ikkawżata mill-varjant tal-virus RHD imsejjaħ virus RHD tat-tip 2 (RHDV2).
English: Other information about Eravac?
Maltese: Kif jaħdem Eravac?
English: The slight temperature increase resolves spontaneously without treatment within 5 days and the local reactions resolve spontaneously within 24 hours.
Maltese: Iż-żieda żgħira fit-temperatura tinżel spontanjament mingħajr kura fi żmien 5 ijiem u rreazzjonijiet lokali jitilqu spontanjament fi żmien 24 siegħa.
English: Protection starts one week after vaccination and lasts 12 months.
Maltese: Il-protezzjoni tibda ġimgħa wara ttilqim u ddum 12-il xahar.
English: Why is Eravac approved in the EU?
Maltese: Għalfejn Eravac huwa awtorizzat fl-UE?
English: How is Eravac used?
Maltese: Kif jintuża Eravac?
English: In the future if rabbits come into contact with rabbit haemorrhagic disease type 2 virus, these antibodies, together with other components of the immune system, will be able to destroy the virus and help protect against the disease.
Maltese: Jekk fil-futur il-fniek jiġu f'kuntatt mal-virus tal-marda emorraġika tal-fniek tat-tip 2, dawn lantikorpi, flimkien ma' komponenti oħra tas-sistema immunitarja, ikunu kapaċi joqtlu l-virus u jgħinu biex jipproteġu kontra l-marda.
English: After vaccination the rabbits were artificially infected with RHDV2.
Maltese: Wara t-tilqima l-fniek ġew infettati artifiċjalment bl-RHDV2.
English: Forceris is a veterinary medicine.
Maltese: Forceris huwa mediċina veterinarja.
English: Further information on Forceris can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/forceris.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/forceris.
English: Other information about Forceris
Maltese: Informazzjoni oħra dwar Forceris
English: Forceris must not be given to piglets suspected to have insufficient levels of vitamin E or selenium.
Maltese: Forceris ma għandux jingħata lill-qżieqeż li huwa ssuspettat li għandhom livelli insuffiċjenti ta' vitamina E jew selenju.
English: Forceris received a marketing authorisation valid throughout the EU on 23 April 2019.
Maltese: Forceris irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fi 23/04/2019.
English: What are the risks associated with Forceris?
Maltese: X'inhuma r-riskji assoċjati ma' Forceris?
English: Toltrazuril is an antiparastic medicine which interferes with the enzymes needed by coccidia parasites to produce energy.
Maltese: It-toltrazuril hija mediċina antiparassitika li tinterferixxi mal-enzimi meħtieġa mill-parassiti koċċidja biex jipproduċu l-enerġija.
English: Care should be taken to avoid accidental self-injection, which may cause local reactions such as irritation, granulomas, or severe anaphylactic (allergic) reactions in sensitive people.
Maltese: Għandha tingħata attenzjoni biex tiġi evitata l-awtoinjezzjoni aċċidentali, li tista' tikkawża reazzjonijiet lokali bħal irritazzjoni, granuloma, jew reazzjonijiet anafilattiċi (allerġiċi) severi f'persuni sensittivi.
English: It is given as a single injection into the muscle behind the ear of piglets between 24 and 96 hours old.
Maltese: Jingħata bħala injezzjoni waħda filmuskolu wara l-widna ta' qżieqeż li jkollhom bejn 24 u 96 siegħa.
English: It is used in young piglets on farms which have been affected by the parasitic infection coccidiosis in the past to prevent diarrhoea caused by a new coccidiosis infection, to reduce spread of the infection through passage of oocysts (disease spores) in faeces, and at the same time to prevent iron deficiency anaemia due to lack of iron in the piglets' diet.
Maltese: Dan jintuża fi qżieqeż żgħar f'irziezet li fil-passat ikunu ġew affettwati mill-infezzjoni parassitika ta' koċċidjożi sabiex tiġi evitata dijarea kkawżata minn infezzjoni ġdida ta' koċċidjożi, biex jitnaqqas it-tixrid tal-infezzjoni permezz tal-passaġġ tal-oċisti (spori tal-mard) fir-rawt, u fl-istess ħin biex tiġi evitata anemija mid-defiċjenza tal-ħadid minħabba nuqqas ta' ħadid fid-dieta tal-qżieqeż.
English: Forceris contains the active substances toltrazuril and gleptoferron (an iron-containing compound).
Maltese: Forceris fih is-sustanzi attivi toltrazuril u gleptoferron (kompost li fih il-ħadid).
English: How is Forceris used?
Maltese: Kif jaħdem Forceris?
English: The other active substance in Forceris, gleptoferron, is an iron-containing compound.
Maltese: Is-sustanza attiva l-oħra f'Forceris, il-gleptoferron, hija kompost li fih il-ħadid.
English: For the full list of side effects and restrictions of Forceris, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Forceris, ara l-fuljett ta' tagħrif.
English: In a field study performed in 3 EU countries and involving over 1,500 piglets, a single intramuscular injection of Forceris given at 24 to 96 hours of age was effective in preventing iron deficiency anaemia,
Maltese: Fi studju fuq il-post li twettaq fi tliet pajjiżi tal-UE u li involva aktar minn 1,500 qażquż, injezzjoni intramuskolari waħda ta' Forceris mogħtija lil qżieqeż li kellhom bejn 24 u 96 siegħa kienet effettiva biex tiġi evitata anemija mid-defiċjenza tal-ħadid, biex titnaqqas l-eskrezzjoni tal-oċisti u biex tiġi evitata d-dijarea assoċjata mal-koċċidjożi kkawżata mill-parassit koċċidja Cystoisospora suis meta mqabbla mal-għoti tal-ħadid waħdu (bħal gleptoferron) fl-ewwel jum wara t-twelid.
English: reducing oocyst excretion and preventing diarrhoea associated with coccidiosis caused by the coccidia parasite Cystoisospora suis, in comparison with giving iron only (as gleptoferron) on the first day after birth.
Maltese: Wara l-injezzjoni fil-muskolu, il-gleptoferron tiġi assorbita u tinqasam biex jiġi rilaxxat il-ħadid għall-użu u/jew għall-ħażna skont il-bżonn nutrizzjonali tal-qażquż.
English: Skin and eye contact with Forceris can cause irritation and should be avoided.
Maltese: Kuntatt mal-ġilda u mal-għajnejn b'Forceris jista' jikkawża irritazzjoni u għandu jiġi evitat.
English: The withdrawal period for meat from pigs treated with Forceris is 70 days.
Maltese: Il-perjodu ta' tiżmim għal-laħam minn qżieqeż ikkurati b'Forceris huwa ta' 70 jum.
English: For more information about using Forceris, see the package leaflet or contact your veterinarian or pharmacist.
Maltese: Għal aktar informazzjoni dwar l-użu ta' Forceris, aqra l-fuljett ta' tagħrif jew ikkuntattja lill-veterinarju jew lill-ispiżjar tiegħek.
English: Oral explanations were given on 9 April 2013.
Maltese: Fid-9 ta' April 2013 kienu mogħtija spjegazzjonijiet orali.
English: International non-proprietary name (INN): amoxicillin and clavulanic acid
Maltese: Isem internazzjonali komuni (INN): amoxicillin u aċidu klavulaniku
English: The Committee appointed Mr J. Schefferlie as rapporteur and Dr J. Bureš as co-rapporteur.
Maltese: Schefferlie bħala rapporteur u lil Dr J.
English: The decentralised procedure started on 29 November 2010.
Maltese: Il-proċedura diċentralizzata bdiet fid-29 ta' Novembru 2010.
English: STRENZEN 500/125 mg/g powder for use in drinking water for pigs contains amoxicillin and clavulanic acid as active ingredients and is intended for use in pigs for the treatment of respiratory tract infections caused by microorganisms susceptible to the combination amoxicillin/clavulanic acid i.e. Actinobacillus pleuropneumoniae, Pasteurella spp, Streptococcus spp.
Maltese: STRENZEN 500/125 mg/g trab għall-użu fl-ilma tax-xorb għall-majjali fih amoxicillin u aċidu klavulaniku bħala sustanzi attivi u huwa maħsub għall-użu fil-majjali għall-kura ta' infezzjonijiet flapparat respiratorju kkawżati minn mikroorganiżmi suxxettibbli għall-kombinazzjoni ta' amoxicillin/aċidu klavulaniku, jiġifieri Actinobacillus pleuropneumoniae, Pasteurella spp, Streptococcus spp. u infezzjonijiet gastrointestinali kkawżati minn Clostridium spp., E. coli u Salmonella spp.
English: The Czech Republic is the reference Member State and Austria, Denmark, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain and the United Kingdom are concerned Member States.
Maltese: Ir-Repubblika Ċeka hija l-Istat Membru ta' riferiment u lAwstrija, id-Danimarka, Franza, il-Ġermanja, l-Irlanda, l-Italja, il-Pajjiżi l-Baxxi, il-Portugall, Spanja u r-Renju Unit huma Stati Membri kkonċernati.
English: This is a generic application according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Amoksiklav 500/125 mg/g powder for use in drinking water authorised in the Czech Republic (MA No. 96/069/98-C).
Maltese: Din hija applikazzjoni ġenerika skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE, kif emendata, li tirreferi għallprodott ta' referenza Amoksiklav 500/125 mg/g trab għall-użu fl-ilma tax-xorb, awtorizzat firRepubblika Ċeka (MA No. 96/069/98-C).
English: The applicant, Novartis Animal Health Inc., submitted an application for a decentralised procedure for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names.
Maltese: L-applikant, Novartis Animal Health Inc., issottometta applikazzjoni għal proċedura diċentralizzata għal STRENZEN 500/125 mg/g trab għall-użu fl-ilma tax-xorb għall-majjali u ismijiet assoċjati.
English: Opinion following an Article 33(4)1 referral for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names
Maltese: Opinjoni wara riferiment għall-Artikolu 33(4)0F għal STRENZEN 500/125 mg/g trab għall-użu fl-ilma tax-xorb għall-majjali u ismijiet assoċjati
English: The opinion was converted into a Decision by the European Commission on 12 August 2013.
Maltese: L-opinjoni nqalbet f'Deċiżjoni mill-Kummissjoni Ewropea fit-12 ta' Awwissu 2013.
English: On 11 July 2012, the reference Member State, the Czech Republic, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Maltese: Fil-11 ta' Lulju 2012, l-Istat Membru ta' riferiment, ir-Repubblika Ċeka, innotifika lill-Aġenzija Ewropea għall-Mediċini li s-CMD(v) naqas milli jilħaq ftehim dwar il-prodott u rrefera l-kwistjoni lis-CVMP skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 2 May 2012.
Maltese: Fil-jum 210, dawn il-kwistjonijiet kienu għadhom ma ġewx solvuti, u għalhekk fit-2 ta' Mejju 2012 ingħata bidu għal riferiment skont l-Artikolu 33(1) tad-Direttiva 2001/82/KE lill-grupp ta' Koordinazzjoni għar-Rikonoxximent reċiproku u l-Proċeduri diċentralizzati (veterinarju) (CMD(v)).
English: and gastrointestinal infections caused by Clostridium spp., E. coli and Salmonella spp.
Maltese: Il-konklużjonijiet xjentifiċi huma pprovduti fl-Anness
English: Day 60 of the CMD(v) procedure was on 29 June 2012, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Maltese: 60 tal-proċedura tas-CMD(v) kien fid-29 ta' Ġunju 2012, u peress li l-Istati Membri kkonċernati naqsu milli jilħqu ftehim dwar il-prodott, il-proċedura ġiet riferuta lis-CVMP.
English: Potential serious risks were identified during the decentralised procedure by the Netherlands and the United Kingdom regarding the environmental safety of the product.
Maltese: Matul il-proċedura diċentralizzata ġew identifikati riskji potenzjali serji mill-Pajjiżi l-Baxxi u r-Renju Unit fir-rigward tas-sigurtà ambjentali talprodott.
English: Preparation:
Maltese: Preparazzjoni:
English: t½ (h)
Maltese: t½ (sigħat)
English: EU/1/15/1046/001 EU/1/15/1046/002 EU/1/15/1046/003 EU/1/15/1046/004 EU/1/15/1046/005 EU/1/15/1046/006 EU/1/15/1046/007 EU/1/15/1046/008 EU/1/15/1046/009 EU/1/15/1046/010
Maltese: EU/1/15/1046/006 EU/1/15/1046/007 EU/1/15/1046/008 EU/1/15/1046/009 EU/1/15/1046/010
English: SE-112 76 Stockholm Sweden
Maltese: SE-112 76 Stockholm
English: 5000 Davis Drive Research Triangle Park, NC 27709 USA
Maltese: Davis Drive Research Triangle Park, NC 27709 L-Istati Uniti tal-Amerika
English: Date of first authorisation: 19 November 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Novembru 2015
English: QR code to be included+ http://www.elocta-instructions.com
Maltese: Kodiċi QR biex tiġi inkluża+ http://www.elocta-instructions.com
English: The specific activity of ELOCTA is 4000-10200 IU/mg protein.
Maltese: L-attività speċifika ta' ELOCTA hi ta' 4,000-10,200 IU/mg.
English: See section 5.2 for pharmacokinetic data.
Maltese: Ara sezzjoni 5.2 għal dejta farmakokinetika.
English: 1500 IU 2000 IU 3000 IU 4000 IU 5000 IU 6000 IU
Maltese: IU 3000 IU 4000 IU 5000
English: Fertility There are no fertility data available.
Maltese: Fertilità M'hemmx dejta disponibbli dwar il-fertilità.
English: Study I*
Maltese: Studju I*
English: Study II
Maltese: Studju II
English: Factor VIII level required (%) (IU/dL)
Maltese: fattur VIII (%) (IU/dL)
English: Uncommon (PTPs)1 Very common (PUPs)1
Maltese: Mhux komuni (PTPs)1
English: Powder: sucrose, sodium chloride, L-Histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, hydrochloric acid.
Maltese: Trab: sucrose, sodium chloride, L-Histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, hydrochloric acid.
English: Activated factor X converts prothrombin into thrombin.
Maltese: Fattur X attivat jibdel prothrombin għal thrombin.
English: 12 to <18 years
Maltese: 12 sa <18-il sena
English: ELOCTA 5000 ELOCTA 6000
Maltese: ELOCTA 6000
English: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Sweden
Maltese: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm
English: Frequency of doses (hours)/ Duration of therapy (days)
Maltese: Frekwenza tad-dożi (sigħat)/Tul tat terapija (jiem)
English: The immunogenicity of ELOCTA was evaluated in the clinical trial programme in 276 previously treated patients with severe haemophilia A (207 adolescents and adult and 69 paediatric patients).
Maltese: Immunoġeniċità L-immunoġeniċità ta' ELOCTA kienet evalwata fil-programm ta' prova klinika f'276 pazjent b'emofilja A severa ttrattati fil-passat (207 pazjenti adolexxenti u adulti u 69 pazjent pedjatriku).
English: 6 to <12 years
Maltese: 6 sa <12-il sena
English: The PK data demonstrate that ELOCTA has a prolonged circulating half-life.
Maltese: Id-dejta PK turi li ELOCTA għandu half-life ċirkolanti mtawla.
English: F) 2 Alcohol swabs G) 2 Plasters
Maltese: F) 2 Biċċiet bl-alkoħol
English: Required units = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL)
Maltese: Unitajiet meħtieġa = piż tal-ġisem (kg) x żieda mixtieqa ta' fattur VIII (%) (IU/dL) x 0.5
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Maltese: Thrombin imbagħad jibdel fibrinogen għal fibrin, u b'hekk ikun jista' jifforma embolu.
English: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sweden
Maltese: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm,
English: ELOCTA contains sodium
Maltese: ELOCTA fih sodium
English: ELOCTA can be used for all age groups.
Maltese: ELOCTA jista' jintuża għall-gruppi kollha ta' età.
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilità, tqala u treddigħ Tqala u treddigħ
English: Paediatric population No age-specific differences in adverse reactions were observed between paediatric and adult subjects.
Maltese: Ma ġiet osservata l-ebda differenza speċifika għall-età fir-reazzjonijiet avversi bejn individwi pedjatriċi u adulti.
English: Administration (Intravenous injection):
Maltese: Għoti (Injezzjoni ġol-vini):
English: Prophylaxis regimens:
Maltese: Korsijiet ta' profilassi:
English: H) 1 Gauze pad
Maltese: A) 1 Kunjett bit-trab
English: The Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: Tabella 2 ippreżentata hawn taħt hi skont is-sistema tal-klassifika tal-organi MedDRA (SOC u Livell ta' Terminu Ppreferut).
English: ELOCTA should be injected intravenously over several minutes.
Maltese: ELOCTA għandu jiġi injettat ġol-vina fuq perjodu ta' diversi minuti.