FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Trevaclyn's benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Trevaclyn huma ikbar mir-riskji tiegħu għat-trattament tad-dislipidemija, b'mod partikolari f'pazjenti b'dislipidemija mħallta kombinata u f‘pazjenti b'livell għoli primarju ta' kolesterol fid-demm.
English: For the full list of all side effects reported with Trevaclyn, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji kollha rrappurtata bi Trevaclyn, ara lFuljett ta' Tagħrif.
English: It contains the active substance rilonacept (80 mg/ml).
Maltese: Fih is-sustanza attiva rilonacept (80 mg/ml).
English: The active substance in Rilonacept Regeneron, rilonacept, is an interleukin inhibitor.
Maltese: Is-sustanza attiva f'Rilonacept Regeneron, rilonacept, hija inibitur tal-interleukin.
English: The starting dose is 4.4 mg per kilogram body weight (up to a maximum of 320 mg), which is followed a week later by once weekly injections of 2.2 mg/kg (up to a maximum of 160 mg).
Maltese: Id-doża tal-bidu hija ta' 4.4 mg kull kilogramm ta' piż tal-ġisem (sa massimu ta' 320 mg), segwita ġimgħa wara b'injezzjonijiet darba fil-ġimgħa ta' 2.2 mg/kg ( sa massimu ta' 160 mg).
English: The full EPAR for Rilonacept Regeneron can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Rilonacept Regeneron jinstab fuq il-websajt tal-Aġenzija taħt EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: Rilonacept Regeneron is used to treat CAPS that are causing severe symptoms in adults and children aged 12 years and older, including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS).
Maltese: Rilonacept Regeneron jintuża fil-kura ta' CAPS li jkunu qed jikkawżaw sintomi gravi fl-adulti u tfal minn 12-il sena 'l fuq, fosthom is-sindromu tar-riħ awtoinflammatorju famlijari (familial cold autoinflammatory syndrome (FCAS)) u s-sindromu Muckle-Wells (Muckle-Wells syndrome (MWS)).
English: Rilonacept Regeneron is used to treat cryopyrin-associated periodic syndromes (CAPS).
Maltese: Rilonacept Regeneron jintuża fit-trattament ta'sindromi perjodiċi assoċjati mal-krijopirin (cryopyrinassociated periodic syndromes (CAPS)).
English: This document is a summary of the European public assessment report (EPAR) for Rilonacept Regeneron.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Rilonacept Regeneron.
English: Other information about Rilonacept Regeneron:
Maltese: Informazzjoni oħra dwar Rilonacept Regeneron:
English: CAPS are a group of diseases where patients have a defect in the gene that produces a protein called cryopyrin.
Maltese: CAPS huma grupp ta' mard fejn il-pazjent ikollu difett fil-ġene li jipproduċi proteina msejħa krijopirin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Arcalyst to Regeneron UK Limited on 23 October 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Arcalyst lil Regeneron UK Limited fit-23 ta' Ottubru 2009.
English: After the sixweek treatment, patients who received Rilonacept Regeneron had a reduction in symptoms of 2.5 points on the scale compared with 0.3 points in patients who received placebo.
Maltese: Wara t-trattament ta' sitt ġimgħat, il-pazjenti li ngħataw Rilonacept Regeneron kellhom tnaqqis fis-sintomi ta' 2.5 punti fuq l-iskala meta mqabbla ma' 0.3 punti f'pazjenti li ngħataw plaċebo.
English: Five symptoms (rash, fever or chills, joint pain, tiredness and eye redness or pain) were assessed by patients themselves on a scale from 0 to 10 points.
Maltese: Ħames sintomi (raxx, deni jew tertir, uġigħ tal-ġogi, għeja u għeja tal-għajnejn jew uġigħ) kienu evalwati mill-pazjenti nfushom fuq skala minn 0 sa 10 punti.
English: It works by attaching to chemical messengers in the body called interleukin-1beta and interleukin-1 alpha. One of these messengers, interleukin-1 beta, is produced at high levels in patients with CAPS, causing inflammation.
Maltese: Dan jaħdem billi jeħel mal-messaġġiera kimiċi fil-ġisem imsejħa interleukin-1beta u interleukin-1 alpha.
English: In the second part of the study, symptoms increased more in patients switched to placebo (0.9 points) compared with patients who remained on Rilonacept Regeneron (0.1 points).
Maltese: Fit-tieni parti tal-istudju, issintomi żdiedu aktar f'pazjenti li qalbu għal plaċebo (0.9 punti) meta mqabbla ma' dawk li baqgħu fuq Rilonacept Regeneron (0.1 punti).
English: Blocking interleukin-1 may interfere with the body's immune response to infection and there have been reports of serious infections in patients taking Rilonacept Regeneron.
Maltese: L-imblukkar ta' interleukin-1 jista' jinterferixxi mar-rispons immunitarju tal-ġisem għall-infezzjoni u kien hemm rapporti ta' infezzjonijiet serji f'pazjenti li kienu qegħdin jieħdu Rilonacept Regeneron.
English: The company that makes Rilonacept Regeneron will provide regular information on the safety and effectiveness of Rilonacept Regeneron in adults and children from a registry and will perform a study in children to further investigate what happens to the medicine in the body.
Maltese: Il-kumpanija li timmanifattura Rilonacept Regeneron ser tipprovdi informazzjoni regolari fuq is-sigurtà u l-effikaċja ta' Rilonacept Regeneron fl-adulti u fit-tfal minn reġistru u ser tagħmel studju fost it-tfal sabiex tinvestiga aktar x'jiġri lill-mediċina fil-ġisem.
English: Because the number of patients with CAPS is low, the diseases are considered ‘rare', and Rilonacept Regeneron was designated an ‘orphan medicine' (a medicine used in rare diseases) on 10 July 2007.
Maltese: Minħabba li n-numru ta' pazjenti b'CAPS huwa wieħed baxx, il-mard huma kkonsidrati bħala ‘rari', u Rilonacept Regeneron ġie denominat bħala ‘mediċina orfni' (mediċina wżata f'mard rari) fl-10 ta' Lulju
English: Adults should be given a starting dose of two injections of 160 mg each in two different parts of the body on the same day.
Maltese: L-adulti għandhom jingħataw doża inizjali ta' żewġ injezzjonijiet ta' 160 mg kull waħda f'żewġ partijiet differenti tal-ġisem fl-istess jum.
English: What is Rilonacept Regeneron?
Maltese: X'hinu Rilonacept Regeneron?
English: What information is still awaited for Rilonacept Regeneron?
Maltese: Liema informazzjoni għadha mistennija għal Rilonacept Regeneron?
English: The most common side effects with Rilonacept Regeneron (seen in more than 1 patient in 10) are reactions at the injection site, upper respiratory tract infections (colds), sinusitis (inflammation of the sinuses) and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Rilonacept Regeneron (li dehru f'iktar minn pazjent 1 minn kull 10) huma r-reazzjonijiet fil-post tal-injezzjoni, infezzjonijiet tal-parti ta' fuq tal-passaġġ respiratorju (irjiħat), sinusite (infjammazzjoni tas-sinus) u wġigħ ta' ras.
English: In the first part of one main study involving 47 patients with CAPS, patients were given either Rilonacept Regeneron or placebo (a dummy treatment) for six weeks.
Maltese: Fl-ewwel parti ta' studju ewlieni li involva 47 pazjent li kienu jbatu b'CAPS, il-pazjenti ngħataw jew Rilonacept Regeneron jew plaċebo (trattament finta) għal sitt ġimgħat.
English: The name of the medicine was changed to Rilonacept Regeneron on 23 July 2010.
Maltese: L-isem tal-mediċina inbidel għal Rilonacept Regeneron fit-23 ta' Lulju 2010.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Rilonacept Regeneron is available here.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat dwar Prodotti Mediċinali Orfni għal Rilonacept Regeneron jista' jiġi kkonsultat hawn.
English: The company that makes Rilonacept Regeneron will provide doctors in all Member States who will use Rilonacept Regeneron with a pack containing the prescribing information, a patient alert card and information for doctors explaining the risk of side effects and how to use the medicine properly.
Maltese: Il-kumpanija li timmanifattura Rilonaacept Regeneron ser tipprovdi lit-tobba fl-Istati Membri kollha li ser jużaw Rilonacept Regeneron b'pakkett li jkun fih l-informazzjoni dwar il-preskrizzjoni, il-kard ta' alert tal-pazjent u informazzjoni għat-tobba fejn jiġi spjegat ir-riskju tal-effetti sekondarji u kif għandha tintuża sew il-mediċina.
English: This leads to inflammation in many parts of the body, with symptoms such as fever, rash, joint pain, and tiredness.
Maltese: Dan iwassal għal fjammazzjoni f'diveri partijiet tal-ġisem, b'sintomi bħad-deni, raxx, uġigħ fil-ġogi, u għejja.
English: Rilonacept Regeneron was more effective than placebo at treating symptoms of CAPS.
Maltese: Rilonacept Regeneron kien aktar effettiv minn plaċebo fil-kura tas-sintomi ta' CAPS.
English: Rilonacept Regeneron is a powder and solvent that are made up into a solution for injection.
Maltese: Rilonacept Regeneron huwa trab u solvent magħmulin f'soluzzjoni għall-injezzjoni.
English: Why has Rilonacept Regeneron been approved?
Maltese: Għaliex ġie approvat Rilonacept Regeneron?
English: The CHMP decided that Rilonacept Regeneron's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Rilonacept Regeneron huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: For the full list of all side effects reported with Rilonacept Regeneron, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Rilonacept Regeneron, ara l-Fuljett ta' Tagħrif.
English: Sanofi-Chimie Route d'Avignon Aramon 30390 France
Maltese: Sanofi-Chimie Route d'Avignon Aramon 30390 Franza
English: 5711 CP Someren The Netherlands
Maltese: 5711 CP Someren L-Olanda
English: Pharming Group N.V., Darwinweg 24, NL-2333 CR LEIDEN, The Netherlands
Maltese: Pharming Group N.V., Darwinweg 24, NL-2333 CR LEIDEN, L-Olanda
English: Time (minutes) to minimal symptoms median (95% CI)
Maltese: Ħin (minuti) għall-medjan tas-sintomi minimi (95% CI)
English: Saline n = 13
Maltese: Salina n = 13
English: Saline n = 16
Maltese: Salina n = 16
English: • Any adverse events
Maltese: • Kwalunkwe avvenimenti avversi
English: 2100 U of conestat alfa.
Maltese: 2100 U ta' conestat alfa
English: • Release the tourniquet.
Maltese: • Erħi t-turnikett.
English: • 1 vial of 20 ml solvent
Maltese: • 1 kunjett b'20 ml ta' solvent
English: • 1 sterile non-woven pad
Maltese: • 1 non-woven pad sterili
English: • The active substance is conestat alfa.
Maltese: • Is-sustanza attiva hi conestat alfa.
English: The complement component (protein) C4, is a substrate for activated C1s.
Maltese: Il-komponent ta' kumpliment (proteina) C4, huwa substrat għal C1s attivati.
English: • 2 vial adapters
Maltese: • 2 adapters tal-kunjett
English: 84 kg and above
Maltese: 84 kg u aktar
English: • Dizziness, throat irritation
Maltese: • Sturdament, irritazzjoni tal-gerżuma
English: 1 powder vial 1 solvent vial 2 vial adapters 1 syringe
Maltese: 1 kunjett bit-trab 1 kunjett bis-solvent 2 adapters tal-kunjett 1 siringa
English: Date of first authorisation: 28 October 2010 Date of latest renewal: 18 September 2015
Maltese: Data tal-aħħar tiġdid: 18 ta' Settembru 2015
English: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000),
Maltese: Rari (≥1/10,000 sa <1/1,000),
English: Marketing Authorisation Holder: Pharming Group N.V.
Maltese: Pharming Group N.V.
English: The active substance is conestat alfa.
Maltese: Is-sustanza attiva hi conestat alfa.
English: Draw in 14 ml of solvent.
Maltese: Iġbed 14 ml ta' solvent.
English: The frequency of adverse reactions listed below is defined using the following convention:
Maltese: Il-frekwenza ta' reazzjonijiet avversi elenkati taħt hija definita permezz tal-konvenzjoni li ġejja:
English: • 1 syringe
Maltese: • 1 siringa
English: Inject the Ruconest solution immediately after preparation, preferably while seated.
Maltese: Injetta s-soluzzjoni ta' Ruconest immedjatament wara l-preparazzjoni, preferibbilment waqt li tkun bilqiegħda.
English: Other medicines and Ruconest
Maltese: Mediċini oħra u Ruconest
English: An additional dose of 50 U/kg was administered for 13/133 (10%) attacks.
Maltese: U/kg għal 13/133 (10%) tal-attakki.
English: Scientific literature indicates an interaction of tissue-type plasminogen activator (tPA) and C1INH containing medicinal products.
Maltese: Letteratura xjentifika tindika interazzjoni ta' attivatur plasminoġen tip ta' tessut (tPA) u C1INH li fih prodotti mediċinali.
English: • Repeat steps 4 and 5 if you need to prepare a second solution.
Maltese: • Irrepeti passi 4 u 5 jekk ikollok bżonn tipprepara t-tieni soluzzjoni.
English: Step 9: Required components
Maltese: Pass 9: Komponenti meħtieġa
English: administered (ml) = body weight (kg) times 50 (U/kg) 150 (U/ml)
Maltese: = piż tal-ġisem (kg) immultiplikat b'50 (U/kg) 150 (U/ml)
English: In a rabbit embryotoxicity study an increase in the incidence of fetal cardiac vessel defects (1.12% in the treatment group versus 0.03% in historical controls) was observed for animals that were administered conestat alfa.
Maltese: Fi studju tal-embrijotossiċità tal-fniek, ġiet osservata żieda fl-inċidenza tad-difetti tal-vettura kardijaka fetali (1.12% fil-grupp tal-kura kontra 0.03% fil-kontrolli storiċi) għal annimali li ngħataw conestat alfa.
English: • The risk of formation of anti-C1INH antibodies and therefore the potential risk of formation of neutralising antibodies.
Maltese: • Ir-riskju ta' formazzjoni ta' antikorpi kontra C1INH u għaldaqstant ir-riskju potenzjali ta'
English: • 1 infusion set with 35 cm tubing and 25G needle
Maltese: • 1 sett tal-infużjoni b'tubu ta' 35 ċm u labra ta' 25G
English: Ruconest contains conestat alfa as the active substance.
Maltese: Ruconest fih conestat alfa bħala s-sustanza attiva.
English: • The potential risk of an immune complex-mediated type III hypersensitivity reaction due to the formation of antibodies directed against Host Related Impurities (HRI).
Maltese: • Ir-riskju potenzjali ta' reazzjoni ta' sensittività eċċessiva tip III medjata b'kumpless immuni dovuta għall-formazzjoni ta' antikorpi diretti kontra Impuritajiet Relatati mal-Ospitu (HRIHost Related Impurities).
English: Ruconest contains sodium (19.5 mg per vial)
Maltese: Ruconest fih sodju(19.5 mg f'kull kunjett)
English: - bodyweight 42 kg or less: 1 powder and 1 solvent vial - bodyweight over 42 kg: 2 powder and 2 solvent vials
Maltese: - piż tal-ġisem ta' 42 kg jew inqas: 1 kunjett bit-trab u 1 kunjett bis-solvent - piż tal-ġisem tra' aktar minn 42 kg: 2 kunjetti bit-trab u 2 kunjetti bis-solvent
English: Chemical and physical in-use stability has been demonstrated for 48 hours between 5˚C and 25˚C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 48 siegħa f'temperatura ta' bejn 5˚C u 25˚C.
English: Within a single kit box, different components may have different expiry dates.
Maltese: F'kaxxa waħda tal-kitt, komponenti differenti jista' jkollhom dati ta' meta jiskadu differenti.
English: Repeat steps 3 and 4 if you need to prepare a second solution (this requires a second kit).
Maltese: Irrepeti passi 3 u 4 jekk ikollok bżonn tipprepara t-tieni soluzzjoni (dan jeħtieġ it-tieni kitt).
English: Ruconest is administered into a vein over about 5 minutes.
Maltese: Ruconest jingħata ġo vina fuq perjodu ta' madwar 5 minuti.
English: After administration of Ruconest (50 U/kg) to asymptomatic HAE patients, a Cmax of 1.36 U/ml was observed.
Maltese: U/kg) għal pazjenti HAE mingħajr sintomi, ġie osservat Cmax ta' 1.36 U/ml.
English: No formal distribution studies have been performed.
Maltese: Ma sarux studji formali dwar id-distribuzzjoni.
English: Ruconest 2100 Units powder and solvent for solution for injection conestat alfa
Maltese: Ruconest 2100 Unità Trab u solvent għal soluzzjoni għal injezzjoni conestat alfa
English: As for plasma-derived C1INH, the pharmacodynamic effects of conestat alfa on C4 show dose-dependent restoration of complement homeostasis in HAE patients at a plasma C1INH activity level greater than 0.7 U/ml, which is the lower limit of the normal range.
Maltese: Bħal fil-każ ta' C1INH derivat mill-plasma, l-effetti farmakodinamiċi ta' conestat alfa fuq C4 juru ritorn dipendenti fuq id-doża ta' omeostażi f'pazjenti b'HAE f'livell ta' attività ta' C1INH tal-plasma ikbar minn 0.7 U/ml, li huwa l-limitu ta' isfel talmedda normali.
English: Tabulated lists of adverse reactions
Maltese: Listi tabulati ta' reazzjonijiet avversi
English: In the randomized controlled trials 39/41 (95%) of patients treated with Ruconest reached time to beginning of relief within 4 hours.
Maltese: Fil-provi kkontrollati randomizzati 39/41 (95%) tal-pazjenti kkurati b'Ruconest laħqu ħin għall-bidu tas-solliev fi żmien 4 sigħat.
English: Never exceed 14 ml per syringe.
Maltese: Qatt taqbeż 14 ml f'kull siringa.
English: Millilitres of prepared solution to be injected below 84 kg bodyweight in kg divided by three
Maltese: Millilitri tas-soluzzjoni ppreparata li tkun se tiġi injettata taħt 84 kg piż tal-ġisem f'kg diviż bi tlieta
English: Nine adolescent HAE patients (aged 13 to 17 years) were treated with 50 U/kg for 26 acute angioedema attacks, and 7 (aged 16 to 17 years) with 2100 U for 24 acute angioedema attacks.
Maltese: anġjoedema akuta, u 7 (ta' bejn 16 u 17-il sena) b'2100 U għal 24 attakk ta' anġjoedema akuta.
English: HAE patients have a heterozygous deficiency of the plasma protein C1INH.
Maltese: Il-pazjenti b'HAE għandhom nuqqas eterożiguż tal-proteina tal-plasma C1INH.
English: = body weight (kg)
Maltese: = Piż tal-ġisem (kg)
English: 1 Unit of conestat alfa activity is defined as the equivalent of C1 esterase inhibiting activity present in 1 ml of pooled normal plasma.
Maltese: Unità waħda ta' attività ta' conestat alfa hija definita bħala l-ekwivalenti tal-attività inibitorja ta' esterase C1 preżenti f'1 ml ta' plasma normali miġbura.
English: 50 and 100 U/kg.
Maltese: U/kg), għal 50 u 100 U/kg.
English: Ruconest is supplied with an administration kit in a carton box containing:
Maltese: Ruconest jiġi pprovdut bħala kitt f'kaxxa tal-kartun li fiha:
English: The distribution volume of conestat alfa was approximately 3 L, comparable to plasma volume.
Maltese: Il-volum ta' distribuzzjoni ta' conestat alfa kien madwar 3 L, meta mqabbel mal-volum tal-plasma.
English: The amino acid sequence of conestat alfa is identical to that of endogenous C1INH.
Maltese: Is-sekwenza tal-amino acid ta' conestat alfa hija identika għal dik ta' C1INH endoġenuż.
English: Each vial of Ruconest (2100 U) should be reconstitued with 14 ml of solvent.
Maltese: Kull kunjett ta' Ruconest (2100 U) għandu jiġi rikostitwit b'14 ml ilma ta' solvent.
English: The plasma protein C1INH is the main regulator of activation of the contact and complement systems in vivo.
Maltese: Il-proteina plasma C1INH hija r-regolatur ewlieni ta' attivazzjoni tas-sistemi ta' kuntatt u ta' kumpliment in vivo.
English: 2100 U of conestat alfa powder in a 25 ml vial (type 1 glass) with a stopper (siliconized chlorobutyl rubber) and a flip-off seal (aluminium and coloured plastic).
Maltese: 2100 U ta' trab ta' conestat alfa f'kunjett ta' 25 ml (ħġieġ tip 1) b'tapp (lastiku ta' chlorobutyl silikonizzat) u b'siġill tat-tip flip-off (aluminju u plastik ikkulurit).
English: Inhibition kinetics were found to be comparable with those observed for plasma-derived human C1INH.
Maltese: Il-kinetiċi ta' inibizzjoni nstabu li kienu komparabbli ma' dawk osservati għal C1INH umani derivati mill-plasma.
English: Data in patients older than 65 years are limited.
Maltese: It-tagħrif f'pazjenti ikbar minn 65 sena huwa limitat.
English: Hypersensitivity reactions cannot be excluded.
Maltese: Reazzjonijiet ta' sensittività eċċessiva ma jistgħux jiġu esklużi.
English: Conestat alfa is a recombinant (not blood-derived) form of human C1 inhibitor (rhC1INH).
Maltese: Conestat alfa huwa għamla rikombinanti (mhux derivata mid-demm) ta' inibitur C1 tal-bniedem (rhC1INH - recombinant human C1 inhibitor).
English: The efficacy and safety in adolescent patients were consistent with that seen in adults.
Maltese: Issigurtà u l-effikaċja f'pazjenti adolexxenti kienu konsistenti ma' dawk osservati fl-adulti.
English: In the study in rats there were no malformed fetuses in either the conestat alfa or the control group.
Maltese: Fl-istudju fil firien, ma kien hemm ebda fetu malformat, la fil-conestat alfa u lanqas fil-grupp ta' kontroll.
English: Administration kit:
Maltese: Pakkett tal-kitt:
English: Ruconest is indicated for treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.
Maltese: Ruconest hu indikat għall-użu ta' attakki ta' anġjoedema akuti fl-adulti u fl-adolexxenti b'anġjoedema ereditarja (HAE) dovuta għal nuqqas ta' inibitur ta' esterase C1.
English: • Position the tourniquet above the injection site - preferably the middle part of the upper arm.
Maltese: • Poġġi t-turnikett fuq is-sit tal-injezzjoni - preferibbilment fil-parti tan-nofs tal-parti ta' fuq tad driegħ.
English: The elimination half-life of conestat alfa was approximately 2 hours.
Maltese: Il-half-life tal-eliminazzjoni ta' conestat alfa kien ta' madwar 2 sagħtejn.
English: • Take the syringe with solvent that you prepared in step 4.
Maltese: • Ħu s-siringa bis-solvent li tkun ippreparajt f'pass 4.
English: Preclinical data do not indicate any safety concern for the use of conestat alfa in humans based on studies of safety pharmacology, single-dose toxicity, two-week sub-chronic toxicity and local tolerance in various animal species including rats, dogs, rabbits and cynomolgus monkeys.
Maltese: Tagħrif ta' qabel l-użu kliniku ma jindika ebda tħassib dwar is-sigurtà għall-użu ta' conestat alfa f'umani fuq il-bażi ta' studji ta' farmakoloġija tas-sigurtà, tossiċità ta' doża waħda, tossiċità subkronika ta' ġimagħtejn u tolleranza lokali f'diversi speċi tal-annimali inkluż firien, klieb, fniek u xadini ċinomolgus.
English: In HAE patients, Ruconest at a dose of 50 U/kg increases plasma C1INH activity level to greater than 0.7 U/ml for approximately 2 hours (see section 5.2).
Maltese: U/kg iżid il-livelli ta' attività ta' C1INH tal plasma għal iktar minn 0.7 U/ml għal madwar 2 sagħtejn (ara sezzjoni 5.2).
English: Powder vial:
Maltese: Kunjett bit-trab:
English: • 2 alcohol pads
Maltese: • 2 tajjariet bl-alkoħol
English: Do not remove the syringe packaging.
Maltese: formazzjoni ta' antikorpi newtralizzanti.
English: Conestat alfa, recombinant human complement component 1 (C1) esterase inhibitor (rhC1INH), is an analogue of human C1INH and is obtained from the milk of rabbits expressing the gene encoding for human C1INH.
Maltese: Conestat alfa, inibitur esterase (C1) komponent kumpliment tal-bniedem rikombinanti (rhC1INH), huwa analogu ta' C1INH uman u jinkiseb mill-ħalib tal-fniek li jesprimu l-kodifikar tal-ġene għal C1INH uman.
English: - Keep this leaflet.
Maltese: Iċċaqlaqx bis saħħa.
English: - Body weight up to 84 kg One intravenous injection of 50 U/kg body weight.
Maltese: - Piż tal-ġisem ta' mhux aktar minn 84 kg Injezzjoni waħda ġol-vini ta' 50
English: How to store Ruconest
Maltese: X'fih Ruconest
English: - Body weight of 84 kg or greater One intravenous injection of 4200 U (two vials).
Maltese: - Piż tal-ġisem ta' 84 kg jew iktar Injezzjoni waħda ġol-vini ta' 4200 U (żewġ kunjetti).
English: Pharmacotherapeutic group: Other haematological agents, drugs used in hereditary angioedema, ATC code: B06AC04.
Maltese: Mediċini Sustanzi ematoloġiċi oħra, mediċini li jintużaw għal anġjoedema ereditarja, kodiċi ATC:
English: • 1 solvent vial
Maltese: • 1 kunjett bis-solvent