FrancophonIA/ELRC3.0 huggingface dataset:
English: For the indication “orthostatic hypotension” the submitted studies were considered by the CHMP of poor methodological quality: they were mainly uncontrolled trials with only 1 double-blind study but with low number of patients.
Maltese: Għall-indikazzjoni “pressjoni baxxa ortostatika” l-istudji ppreżentati kienu meqjusa mis-CHMP bħala ta' kwalità metodoloġika fqira: dawn kienu prinċipalment provi mhux ikkontrollati, bi studju wieħed biss li kien bi blindaġġ doppju imma b'għadd baxx ta' pazjenti.
English: The CHMP noted the position of several MAHs that there is not enough evidence to support an indication of oral dihydroergotamine in the symptomatic treatment of veno-lymphatic insufficiency and was of the opinion that no scientific conclusion can be drawn regarding the efficacy of dihydroergotamine based on these study results.
Maltese: Is-CHMP innota l-pożizzjoni ta' bosta MAHs li ma hemmx biżżejjed evidenza biex tappoġġa indikazzjoni ta' dihydroergotamine orali fil-kura sintomatika ta' insuffiċjenza veno-limfatika u kien tal-fehma li abbażi ta' dawn ir-riżultati tal-istudju ma tista' tinġibed l-ebda konklużjoni xjentifika dwar l-effikaċja ta' dihydroergotamine.
English: To conclude, given the cases reported for a reaction difficult to diagnose early (delayed symptoms) and probably under reported, the use of the drug at an approved dosage, added to a plausible pharmacological profile, dihydroergotamine is considered to be strongly associated with a risk of fibrotic reactions.
Maltese: Bħala konklużjoni, minħabba l-każijiet irrapportati għal reazzjoni li diffiċli tiġi dijanjostikata kmieni (sintomi ttardjati) u probabbilment mhux daqshekk irrapportata, l-użu tal-mediċina f'doża approvata, flimkien ma' profil farmakoloġiku plawżibbli, dihydroergotamine huwa meqjus li huwa assoċjat mill-qrib ma' riskju ta' reazzjonijiet fibrotiċi.
English: • Prophylaxis of migraine headache
Maltese: • Profilassi tal-uġigħ ta' ras tal-emigranja
English: The efficacy of dihydroergotamine in the prevention of migraine in this study has not been demonstrated taking into account that there was no statistically significant difference between dihydroergotamine and placebo with respect to the reduction of the frequency of migraine attacks (the primary efficacy criterion) in the overall population.
Maltese: L-effikaċja ta' dihydroergotamine filprevenzjoni tal-emigranja f'dan l-istudju ma ntwerietx meta wieħed jikkunsidra li ma kien hemm lebda differenza statistikament sinifikanti bejn dihydroergotamine u l-plaċebo fir-rigward tat-tnaqqis tal-frekwenza tal-attakki tal-emigranja (il-kriterju primarju tal-effikaċja) fil-popolazzjoni ġenerali.
English: A total of 363 subjects were treated with dihydroergotamine or placebo during 4 months after 1 month of placebo “run-in”.
Maltese: Total ta' 363 individwu rċevew kura b'dihydroergotamine jew plaċebo għal 4 xhur wara xahar ta' “run-in” bi plaċebo.
English: Ergotism is a serious reaction, which leads in rare cases reported to important sequelae following amputation or colon resection for example.
Maltese: L-ergotiżmu huwa reazzjoni serja, li f'każijiet rari rrapportati jwassal għal konsegwenzi negattivi importanti wara pereżempju amputazzjoni jew risezzjoni tal-kolon.
English: In the only recent, large study with appropriate design (PROMISE study) there was no statistically significant difference between dihydroergotamine and placebo with respect to the reduction of the frequency of migraine attacks (the primary efficacy criterion) in the overall population.
Maltese: Fl-uniku studju kbir, riċenti u b'disinn adegwat (l-istudju PROMISE) ma kien hemm l-ebda differenza statistikament sinifikanti bejn dihydroergotamine u plaċebo fir-rigward tat-tnaqqis tal-frekwenza tal-attakki tal-emigranja (il-kriterju primarju tal-effikaċja) fil-popolazzjoni ġenerali.
English: In the acute treatment of migraine, it is administered parenterally or in the form of a nasal spray because of the low bioavailability of the unchanged drug by the oral route.
Maltese: Fil-kura akuta tal-emigranja, jingħata b'mod parenterali jew fil-forma ta' sprej nażali minħabba lbijodisponibilità baxxa tal-mediċina mhux mibdula mir-rotta orali.
English: − Prophylaxis of migraine headache.
Maltese: Profilassi tal-uġigħ ta' ras tal-emigranja.
English: − Is not favourable for orthostatic hypotension.
Maltese: Mhuwiex favorevoli għall-pressjoni baxxa ortostatika.
English: Agonism to 5-HT2B receptors induces a proliferative response and mitogenicity of the cells expressing this receptor leading to fibrogenesis.
Maltese: L-agoniżmu għarriċetturi ta' 5-HT2B jinduċi rispons proliferattiv u mitoġeniċità taċ-ċelloli li jesprimu dan riċettur li jwassal għal fibroġenesi.
English: On the efficacy side for the indication “prophylaxis of migraine headache” data derive from a few randomised, double-blind, placebo-controlled studies or double-blind non placebo-controlled and open label studies, the majority of which was conducted after the granting of the initial marketingauthorisation.
Maltese: Fir-rigward tal-effikaċja għall-indikazzjoni “profilassi tal-uġigħ ta' ras tal-emigranja” id-dejta ġejja minn ftit studji aleatorji, bi blindaġġ doppju, ikkontrollati bi plaċebo jew studji bi blindaġġ doppju mhux ikkontrollati bi plaċebo u b'tikketta miftuħa, li l-maġġoranza tagħhom saru wara l-għoti talawtorizzazzjoni inizjali għat-tqegħid fis-suq.
English: However, given the number of cases reported with dihydroergotamine, with symptoms related to ergotism (despite probable lacking cases) even when dihydroergotamine is used as recommended (no overdosage, no contraindicated drug, and short time treatment), the high pharmacological plausibility and a suggestive chronology in most of the cases, it is considered that patients are exposed to a high risk of ergotism when treated with dihydroergotamine.
Maltese: Madankollu, minħabba l-għadd ta' każijiet irrapportati b'dihydroergotamine, b'sintomi relatati mal-ergotiżmu (minkejja l-probabbiltà ta' każijiet nieqsa) anke meta dihydroergotamine jintuża kif rakkomandat (l-ebda doża eċċessiva, l-ebda mediċina kontraindikata, u kura fuq żmien qasir), il-plawżibilità farmakoloġika għolja u kronoloġija suġġestiva fil-maġġoranza tal-każijiet, huwa meqjus li meta jirċievu kura b'dihydroergotamine lpazjenti jiġu esposti għal riskju għoli ta' ergotiżmu.
English: • Fibrosis is mentioned in several current European Summaries of Product Characteristics (SmPCs) and expected reactions are often under-reported
Maltese: • Il-fibrożi hija msemmija f'bosta Sommarji tal-Karatteristiċi tal-Prodott (SmPCs) Ewropej u ħafna drabi ikun hemm nuqqas ta' rapportar tar-reazzjonijiet mistennija
English: • The Committee is of the opinion that the evidence for clinically significant efficacy of oral dihydroergotamine in the currently assessed indications is very limited, and therefore the potential benefit for patients in these indications is outweighed by the above identified risk.
Maltese: • Il-Kumitat huwa tal-fehma li l-evidenza għall-effikaċja klinikament sinifikanti ta' dihydroergotamine orali fl-indikazzjonijiet attwalment ivvalutati hija limitata ħafna, u għalhekk il-benefiċċju potenzjali għall-pazjenti f'dawn l-indikazzjonijiet huwa megħlub mir-riskju identifikat hawn fuq.
English: • The variation to the terms of the marketing authorisation for dihydroergotamine containing medicinal products referred to in Annex I, to delete the below indications from the Product Information (specific wording of the indication may vary from product to product and from country to country) as well as any relevant reference to these indications in the Product Information, when there are other therapeutic indications approved as part of their marketing authorisation:
Maltese: • Il-varjazzjoni fit-termini tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodotti mediċinali li fihom dihydroergotamine msemmija fl-Anness I, it-tneħħija tal-indikazzjonijiet ta' hawn taħt millInformazzjoni dwar il-Prodott (il-kliem speċifiku tal-indikazzjoni jista' jvarja minn prodott għallieħor u minn pajjiż għall-ieħor) kif ukoll kwalunkwe referenza rilevanti għal dawn l-indikazzjonijiet fl-Informazzjoni dwar il-Prodott, meta jkun hemm indikazzjonijiet terapewtiċi oħra approvati bħala parti mill-awtorizzazzjoni għat-tqegħid fis-suq tagħhom:
English: Moreover, the number of cases reported with a contraindicated concomitant drug reveals that information in the SmPC is not sufficient to avoid an exposition of the patient to the serious risk of ergotism.
Maltese: Barra minn hekk, l-għadd ta' każijiet irrapportati b'mediċina konkomitanti kontraindikata juri li l-informazzjoni fl-SmPC mhijiex biżżejjed biex tiġi evitata l-espożizzjoni tal-pazjent għar-riskju serju tal-ergotiżmu.
English: Moreover, given the seriousness of ergotism and its consequences (sequelae, need for surgery, amputation), the young age of the patients with symptoms of ergotism and the short time to onset of the reaction, the safety profile of dihydroergotamine is highly questionable.
Maltese: Barra minn hekk, minħabba s-serjetà tal-ergotiżmu u l-konsegwenzi tiegħu (konsegwenzi negattivi, il-ħtieġa ta' kirurġija, amputazzjoni), l-età żgħira tal pazjenti b'sintomi ta' ergotiżmu u ż-żmien qasir għall-bidu tar-reazzjoni, il-profil tas-sigurtà ta'dihydroergotamine huwa ferm dubjuż.
English: − Is not favourable for symptomatic treatment of veno-lymphatic insufficiency.
Maltese: Mhuwiex favorevoli għall-kura sintomatika ta' insuffiċjenza veno-limfatika.
English: From the approved indications of the dihydroergotamine containing medicinal products the ones that are in the scope of this referral procedure and are approved in at least one Member State are the following (specific wording of the indication may vary from product to product):
Maltese: Mill-indikazzjonijiet approvati tal-prodotti mediċinali li fihom dihydroergotamine, dawk li huma fil-kamp ta' applikazzjoni ta' din il-proċedura ta' referenza u li huma approvati f'mill-inqas Stat Membru wieħed huma dawn li ġejjin (il-kliem speċifiku tal-indikazzjoni jista' jvarja minn prodott għall-ieħor):
English: However the CHMP noted that beta blockers are not widely recognised as a cause of fibrosis.
Maltese: Madankollu sCHMP innota li l-imblokkaturi beta mhumiex ġeneralment rikonoxxuti bħala l-kawża ta' fibrożi.
English: There is little evidence from double-blind, placebo-controlled clinical trials and no uniform picture of the efficacy of oral ergotamine compared to placebo or other substances in the prevention of migraine emerges from these studies since studies reported both positive and negative results.
Maltese: Ftit hemm evidenza minn provi kliniċi bi blindaġġ doppju, ikkontrollati bi plaċebo u minn dawn l-istudji ma toħroġ l-ebda stampa uniformi taleffikaċja ta' ergotamina orali meta mqabbla ma' plaċebo jew sustanzi oħra fil-prevenzjoni tal-emigranja, peress li l-istudji rrapportaw riżultati kemm pożittivi kif ukoll negattivi.
English: How to report side effects
Maltese: Kif tirrapporta effetti sekondarji
English: For more information, visit www.ema.europa.eu
Maltese: Għal aktar tagħrif, żur www.ema.europa.eu
English: "This medicinal product is subject to additional monitoring."
Maltese: "Dan il-prodott mediċinali huwa soġġett għal monitoraġġ addizzjonali."
English: Visit your national medicines regulator at: www.mhra.gov.uk (United Kingdom) www.imb.ie (Ireland) www.medicinesauthority.gov.mt (Malta)
Maltese: www.medicinesauthority.gov.mt
English: Why are medicines monitored after they are approved?
Maltese: Wara li jiġu approvati, il-mediċini għaliex jitqiegħdu taħt sorveljanza?
English: Examples of medicines under additional monitoring include new medicines authorised since the start of 2011 and medicines for which regulators require more studies to be carried out, e.g. on long-term use or on rare side effects seen in clinical trials.
Maltese: Eżempji ta' mediċini taħt sorveljanza addizzjonali jinkludu mediċini ġodda awtorizzati mill-bidu tal-2011 u mediċini li għalihom ir-regolaturi jeħtieġu li jitwettqu aktar studji, eż. dwar l-użu fit-tul jew dwar effetti sekondarji rari li dehru fil-provi kliniċi.
English: Clinical trials usually involve a limited number of patients for a defined time period in controlled conditions.
Maltese: Normalment, il-provi kliniċi jinvolvu għadd limitat ta' pazjenti għal perjodu ta' żmien definit f'kundizzjonijiet ikkontrollati.
English: European regulatory authorities decide to authorise medicines after assessing the results of laboratory tests and clinical trials.
Maltese: L-awtoritajiet regolatorji Ewropej jiddeċiedu li jawtorizzaw mediċini wara li jivvalutaw ir-riżultati tat-testijiet tal-laboratorju u tal-provi kliniċi.
English: What does the black triangle mean?
Maltese: It-triangolu iswed xi jfisser?
English: These medicines have a black inverted triangle displayed in their package leaflet, together with a short sentence that reads:
Maltese: Dawn il-mediċini għandhom triangolu iswed bil-maqlub muri fuq il-fuljett ta' tagħrif tagħhom, flimkien ma' sentenza qasir li taqra:
English: In a real-life setting, a larger and more diverse group of patients will use the medicine.
Maltese: Fir-realtà, il-mediċina se tintuża minn grupp ikbar u iktar varjat ta' pazjenti.
English: All medicines are carefully monitored after they are placed on the EU market.
Maltese: Il-mediċini kollha jiġu ssorveljati bir-reqqa wara li jitqiegħdu fis-suq tal-UE.
English: This is generally because there is less information available about them compared with other medicines, for example because they are new on the market.
Maltese: Normalment, dan isir għaliex ikun hemm inqas informazzjoni disponibbli dwarhom meta mqabbla ma' mediċini oħra, pereżempju għaliex għadhom ġodda fis-suq.
English: By reporting side effects, you can help medicines regulators assess whether the benefits of a medicine remain greater than its risks.
Maltese: Billi tirrapporta effetti sekondarji, tista' tgħin lir-regolaturi tal-mediċini jivvalutaw jekk il-benefiċċji ta' mediċina jibqgħux jisbqu r-riskji tagħha.
English: You can report side effects to your doctor, pharmacist or nurse.
Maltese: Tista' tirrapporta effetti sekondarji lit-tabib, lill-ispiżjar jew lill-infermier tiegħek.
English: Some less common side effects may only be apparent when a medicine has been used for a long time by a large number of people.
Maltese: Għalhekk, huwa ferm importanti li s-sigurtà tal-mediċini kollha tibqa' tiġi ssorveljata filwaqt li jkunu fis-suq.
English: Invented name Strength
Maltese: Numru ta' l-EU Isem inventat
English: Pharmaceutical Form Route of Administration Packaging
Maltese: Għamla farmaċewtika
English: Uferstraße 15
Maltese: Uferstrasse 15
English: 6.2 Incompatibilities
Maltese: 6.2 Inkompatibilitajiet
English: Hypersensitivity a)
Maltese: Sensittività eċċessiva a)
English: ATC code: B02BD04.
Maltese: B02BD04.
English: The osmolality is greater than 240 m osmol/kg.
Maltese: L-osmolalità hi aktar minn 240 m osmol/kg.
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: 17 IDENTIFIKATUR UNIKU - BARCODE 2D
English: Nephrotic syndrome
Maltese: Sindrome nefrotiku
English: RIXUBIS Repeat Evaluation (N=23)
Maltese: RIXUBIS Evalwazzjoni Ripetuta (N=23)
English: Patients aged 12 to 17 years of age:
Maltese: Pazjenti minn età ta' 12 sa 17-il sena:
English: One vial contains 19 mg sodium.
Maltese: Kunjett wieħed fih 19 mg ta' sodium.
English: Excipients: sodium chloride, sucrose, calcium chloride, histidine, mannitol, polysorbate 80.
Maltese: Eċċipjenti: sodium chloride, sucrose, calcium chloride, histidine, mannitol, polysorbate 80.
English: Prophylaxis:
Maltese: Profilassi:
English: EU/1/14/970/001 EU/1/14/970/002 EU/1/14/970/003 EU/1/14/970/004 EU/1/14/970/005
Maltese: EU/1/14/970/001 EU/1/14/970/002 EU/1/14/970/003 EU/1/14/970/004
English: Patients undergoing major surgeries had to perform a pharmacokinetic (PK) evaluation.
Maltese: Pazjenti li kellhom operazzjonijiet maġġuri, kellhom iwettqu evalwazzjoni farmakokinetika (PK).
English: x reciprocal of observed recovery (dL/kg)
Maltese: x reciprocal ta' irkuprar osservat (dL/kg)
English: RIXUBIS Initial cross-over study (N=25)
Maltese: RIXUBIS Studju inizjali tat-tip cross-over (N=25)
English: Incremental recovery 30 min after infusion
Maltese: Irkuprar inkrementali 30 minuta wara l-infużjoni
English: Frequencies have been evaluated according to the following convention: 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), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi ġew evalwati skont il-konvenzjoni li ġejja: komuni ħafna (1/10), komuni(1/100 sa <1/10), mhux komuni(1/1,000 sa <1/100), rari (1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Fertility There is no information on the effects of factor IX on fertility.
Maltese: Fertilità M'hemm l-ebda informazzjoni dwar l-effetti tal-fattur IX fuq il-fertilità.
English: Incremental recovery 30 min after infusion (IU/dL: IU/kg)a
Maltese: Irkuprar inkrementali 30 minuta wara l-infużjoni (IU/dL: IU/kg)
English: The RIXUBIS dose range in the repeat pharmacokinetics study was 64.48 to 79.18 IU/kg (n=23).
Maltese: Il-medda tad-doża ta' RIXUBIS fl-istudju ripetut dwar il-farmakokinetika kienet ta' 64.48 sa 79.18 IU/kg (n=23).
English: Adverse Drug Reactions, from clinical trials and spontaneous reports MedDRA Standard System Organ Class
Maltese: Reazzjonijiet Avversi tal-Mediċina, minn provi kliniċi u rapporti spontanji Sistema Standard tal-Klassifika ta' l-Organi fid-database tal-MedDRA
English: Nonacog gamma (recombinant coagulation factor IX) is a single-chain purified glycoprotein that has 415 amino acids.
Maltese: Nonacog gamma (fattur IX tal-koagulazzjoni rikombinanti) hu glikoproteina ppurifikata ta' katina waħda li għandha 415 amino acids.
English: Solvent vial: 5 ml sterilised water for injections.
Maltese: Kunjett bis-solvent: 5 ml ilma sterilizzat għall-injezzjonijiet.
English: Mean±SD
Maltese: Medja±SD
English: Of the 26 bleeding episodes, 15 were minor, 9 moderate, and 2 major.
Maltese: Minn total ta' 26 episodju ta' ħruġ ta' demm, 15 kienu minuri, 9 moderati 2 maġġuri.
English: The safety and efficacy in the perioperative setting was evaluated in a phase 3 prospective, open-label, uncontrolled, multicenter study in male PTPs with severe and moderately severe haemophilia B using RIXUBIS.
Maltese: Is-sigurtà u l-effikaċja fl-isfond perioperattiv ġew evalwati fi studju ta' fażi 3, prospettiv, open-label, mhux ikkontrollat u multiċentriku, f'PTPs irġiel b'emofilija B severa u moderatament severa li jużaw RIXUBIS.
English: RIXUBIS contains sodium
Maltese: RIXUBIS fih is-sodium
English: Median (range) Cmax (IU/dL) Mean±SD
Maltese: Medjan (medda) Cmax (IU/dL) Medja±SD
English: 6 - < 12 years (N=12)
Maltese: 6 - < 12-il sena (N=12)
English: RIXUBIS did not cause any adverse clinical, respiratory, or cardiovascular effects up to 450 IU/kg in cynomolgus monkeys.
Maltese: RIXUBIS ma kkawża l-ebda effetti kliniċi avversi, respiratorji, jew kardjovaskulari f'doża sa 450 IU/kg f'xadini cynomolgus.
English: Each powder vials contains nominally 250, 500, 1000, 2000 or 3000 IU, corresponding to a concentration of 50, 100, 200, 400 or 600 IU/ml after reconstitution with 5 ml solvent.
Maltese: Kull kunjett bit-trab nominalment ikun fih 250, 500, 1000, 2000 jew 3000 IU li jikkorrispondu għal konċentrazzjoni ta' 50, 100, 200, 400 jew 600
English: Week 5 (N=71)
Maltese: Ġimgħa 5 (N=71)
English: The mean treatment duration in the on-demand cohort was 3.5±1.00 months (median 3.4, ranging from 1.2 to 5.1 months), the mean total annualised bleeding rate (ABR) was 33.9±17.37 with a median of 27.0, ranging from 12.9 to 73.1.
Maltese: It-tul medju tal-kura fil-koorti ta' kura fil-pront kie ta' 3.5±1.00 xhur (medjan 3.4, li jvarja minn 1.2 sa 5.1 xhur), ir-rata medja totali ta' ħruġ ta' demm annwalizzat (ABR) kienet ta' 33.9±17.37 b'medjan ta' 27.0, li tvarja minn 12.9 sa 73.1.
English: Of a total of 249 bleeding episodes, 163 were moderate, 71 were minor, and 15 were major.
Maltese: Minn total ta' 249 episodju ta' ħruġ ta' demm, 163 kienu moderati, 71 kienu minuri, u 15 kienu maġġuri.
English: Week 26 (N=55)
Maltese: Ġimgħa 26 (N=55)
English: Treatment was individualised based on the severity, cause and site of bleed The majority (23; 88,5%) were treated with 1-2 infusions.
Maltese: Il-maġġoranza (23; 88.5%) ġew ikkurati b'infużjoni 1 sa 2 infużjonijiet.
English: = body weight (kg) x desired factor IX rise (%) or (IU/dL)
Maltese: = piż tal-ġisem (kg) x żieda mixtieqa ta' fattur IX (%) jew (IU/dL)
English: Attach a butterfly needle to the syringe.
Maltese: Waħħal labra butterfly mas-siringa.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor IX.
Maltese: Kategorija farmakoterapewtika: antiemorraġiċi, fattur IX tal-koagulazzjoni tad-demm.
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Maltese: Hemm riskju potenzjali ta' episodji tromboemboliċi wara l-għoti ta' prodotti li fihom fattur IX, b'riskju ogħla għal preparazzjonijiet b'purità baxxa.
English: The recommended initial loading dose of RIXUBIS was to ensure that during surgery, factor IX activity levels of 80-100% for major surgeries and 30-60% for minor surgeries were maintained.
Maltese: Id-doża qawwija tal-bidu inizjali rakkomandata ta' RIXUBIS kienet biex jiġi żgurat li waqt l-operazzjoni, jinżammu livelli ta' attività ta' fattur IX ta' 80-100% għal operazzjonijiet maġġuri u 30-60% għal operazzjonijiet minuri.
English: Posology is the same in adults and paediatric population from 12 to 17.
Maltese: Il-pożoloġija hija l-istess fl-adulti u fil-popolazzjoni pedjatrika minn 12 sa 17-il sena.
English: One pack contains a powder vial (type I glass) with a stopper (butyl rubber) and a flip-off seal, a vial containing 5 ml solvent (type I glass) with a stopper (chlorobutyl rubber) and a flip-off seal and a needle-less reconstitution device (BAXJECT II).
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih u apparat speċjali għall-użu Pakkett wieħed fih kunjett bit-trab (ħġieġ ta' tip I) b'tapp (tal-lastku butyl) u siġill flip-off, kunjett li fih 5 ml ta' solvent (ħġieġ ta' tip I) b'tapp (tal-lastku chlorobutyl) u siġill flip-off u tagħmir għar-rikostituzzjoni bla labra (BAXJECT II).
English: Median (range) Half-life (hr) Mean±SD
Maltese: Medjan (medda) Half-life (sigħat) Medja±SD
English: The pharmacokinetic evaluation was repeated for RIXUBIS in an open-label, uncontrolled study with RIXUBIS in male subjects who participated in the initial PK crossover study and had received prophylaxis with RIXUBIS for 26±1 weeks (mean ± SD) and accumulated at least 30 exposure days (EDs) to RIXUBIS.
Maltese: L-evalwazzjoni farmakokinetika ġiet ripetuta għal RIXUBIS fi studju open-label u mhux ikkontrollat b'RIXUBIS f'individwi rġiel li pparteċipaw fl-istudju inizjali tat-tip crossover PK u li kienu rċivew profilassi b'RIXUBIS għal 26±1 ġimgħa (medja ± SD) u akkumulaw mill-inqas 30 jum ta' esponiment (EDs) għal RIXUBIS.
English: The efficacy of RIXUBIS has been evaluated in a combined phase 2/3 study, in which a total of 23 male PTPs between 1.8 and 11.8 years (median age 7.10 years) with 11 patients < 6 years, received RIXUBIS for prophylaxis and control of bleeding episodes.
Maltese: L-effikaċja ta RIXUBIS ġiet evalwata fi studju kombinat ta' fażi 2/3, li fih total ta' 23 PTPs irġiel li kellhom bejn 1.8 u 11.8 snin (età medjana ta' 7.10 snin) bi 11-il pazjent li kellhom <6 snin, irċivew RIXUBIS għall-profilassi u l-kontroll ta' episodji ta' ħruġ ta' demm.
English: - The other ingredients in the powder are sucrose, mannitol, sodium chloride, calcium chloride, L-histidine, polysorbate 80.
Maltese: - Is-sustanzi l-oħra fit-trab huma sucrose, mannitol, sodium chloride, calcium chloride, L-histidine, polysorbate 80.