FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy results for FAST-1 and FAST-2
Maltese: Tabella 3. Riżultati tal-effikaċja għal FAST-1 u FAST-2
English: Firazyr is intended for subcutaneous administration preferably in the abdominal area.
Maltese: Firazyr huwa maħsub sabiex jingħata minn taħt il- ġilda preferibbilment fiż-żona addominali.
English: In a study of 39 healthy adult men and women treated with 30 mg every 6 hours for 3 doses every 3 days for a total of 9 doses, there were no clinically significant changes from baseline in basal and GnRH-stimulated concentration of reproductive hormones in either females or males.
Maltese: Fi studju ta' 39 raġel u mara adulti b'saħħithom, ikkurati bi 30 mg kull 6 sigħat għal 3 dożi kull 3 ijiem għal total ta' 9 dożi, ma kien hemm ebda tibdil klinikament sinifikanti mil-linja bażi fil-konċentrazzjoni basali u stimulata b'GnRH ta' ormoni riproduttivi f'nisa jew f'irġiel.
English: • 3 ml (recommended) graduated syringe
Maltese: • Siringa gradwata ta' 3 ml (rakkomandata)
English: Transaminases increased
Maltese: Aċidu traneżamiku
English: An open label, non-randomised single-arm study (HGT-FIR-086) was performed with a total of 32 patients.
Maltese: Sar studju open label, mhux randomizzat ta' fergħa waħda (HGT-FIR-086) b'total ta' 32 pazjent.
English: Where the dose is less than 30 mg (3 ml), the following equipment is required to extract the appropriate dose (see below): a) Firazyr pre-filled syringe (containing icatibant solution) b) Connector (adapter) c) 3 ml graduated syringe
Maltese: Fejn id-doża tkun inqas minn 30 mg (3 ml), huwa meħtieġ l-apparat li ġej sabiex tinġibed id-doża xierqa (ara hawn taħt): a) Firazyr siringa mimlija għal-lest (li jkun fiha s-soluzzjoni ta' icatibant) b) Konnettur (adapter) c) Siringa gradwata ta' 3 ml
English: Maximum daily exposures defined by area under the curve (AUC) at the No Observed Adverse Effect Levels (NOAEL) in the 9-month study in dog were 2.3 times the AUC in adult humans after a subcutaneous dose of 30 mg. A NOAEL was not measurable in the rat study, however, all of the findings from that study showed either completely or partially reversible effects in treated rats.
Maltese: L-esponimenti massimi tal-ġurnata definiti bl-erja taħt il-kurva (AUC) fil-Livelli fejn Ma Kienu Osservati Ebda Effetti Avversi (NOAEL) fl-istudju ta' disa' xhur fil-kelb kienu 2.3 drabi l-AUC filbniedem adult wara doża taħt il-ġilda ta' 30 mg. NOAEL ma kienx miżurabbli fl-istudju tal-far, madankollu, is-sejbiet kollha minn dak l-istudju urew jew effetti riversibbli għal kollox jew parzjalment riversibbli fil-firien ikkurati.
English: This patient was followed for 5 months and further samples were negative for anti-icatibant antibodies.
Maltese: Dan ilpazjent ġie segwit għal 5 xhur u aktar kampjuni kienu negattivi għal antikorpi anti-icatibant.
English: No clinical information on overdose is available.
Maltese: M'hemmx informazzjoni klinika disponibbli dwar doża eċċessiva.
English: Abnormal liver function test
Maltese: Test tal-funzjoni tal-fwied mhux normali
English: Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.
Maltese: Firazyr huwa indikat għat-trattament sintomatiku ta' attakki akuti ta' anġjoedema ereditarja (HAE) fladulti, fl-adolexxenti u fit-tfal minn età ta' sentejn jew aktar, b'defiċjenza fl-inibitur C1 esterażi.
English: Primary Endpoint Time to Onset of Symptom Relief-- Composite VAS (hrs)
Maltese: Endpoint primarju Ħin għall-Bidu tas-Solljiev mis-Sintomi -- VAS kompost (sigħat)
English: 6.9 All episodes (N = 56)
Maltese: 6.9 L-episodji kollha (N = 56)
English: In the clinical trials, not more than 8 injections of Firazyr per month have been administered.
Maltese: Fil-provi kliniċi, ma ngħatawx aktar minn 8 injezzjonijiet ta' Firazyr fix-xahar.
English: Similar effects of icatibant on reproductive tissue were seen in sexually mature rats and dogs.
Maltese: Dehru effetti simili ta' icatibant fuq it-tessut riproduttiv f'firien u klieb sesswalment maturi.
English: The other ingredients are sodium chloride, acetic acid glacial, sodium hydroxide and water for injection.
Maltese: Issustanzi l-oħra huma sodium chloride, acetic acid glacial, sodium hydroxide u ilma għall-injezzjoni.
English: At 1 and 2 hours post treatment, approximately 50% and 90% of patients experienced onset of symptom relief, respectively.
Maltese: Siegħa u sagħtejn wara l-kura, madwar 50 % u 90 % tal-pazjenti esperjenzaw bidu tas-solljev mis-sintomi, rispettivament.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Ipersensittività għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: In a standard battery of in vitro and in vivo tests icatibant was not genotoxic.
Maltese: F'batterija standard ta' testijiet in vitro u in vivo, icatibant ma kellux effett tossiku fuq il-ġeni.
English: Although there is evidence to support a beneficial effect of B2 receptor blockade immediately following a stroke, there is a theoretical possibility that icatibant may attenuate the positive late phase neuroprotective effects of bradykinin.
Maltese: Għalkemm hemm evidenza li ssostni effett benefiku ta' mblokk tar-riċettur B2 immedjatament wara puplesija, hemm possibilità teoretika li icatibant jista' jnaqqas l-effetti newroprotettivi pożittivi fi stadju tardiv ta' bradykinin.
English: Phase III clinical studies (FAST-1 and FAST-2) were randomized, double-blind, controlled trials and had identical designs except for the comparator (one with oral tranexamic acid as the comparator and one placebo controlled).
Maltese: III (FAST-1 u FAST-2) kienu provi randomizzati, double-blind, ikkontrollati u kellhom disinni identiċi għajr għall-komparatur (wieħed b'aċidu traneżamiku orali bħala l-komparatur u wieħed ikkontrollat l-plaċebo).
English: A total of 130 patients were randomized to receive either a 30 mg dose of icatibant (63 patients) or comparator (either tranexamic acid, - 38 or placebo - 29 patients).
Maltese: Total ta' 130 pazjent ġew magħżula b'mod każwali biex jirċievu jew doża ta' 30 mg icatibant (63 pazjent) jew komparatur (jew aċidu traneksamiku, 38 jew plaċebo 29 pazjent).
English: * Injection site bruising, Injection site hematoma, Injection site burning, Injection site erythema, Injection site hypoesthesia, Injection site irritation, Injection site numbness, Injection site edema, Injection site pain, Injection site pressure sensation, Injection site pruritus, Injection site swelling, Injection site urticaria, and Injection site warmth.
Maltese: Żieda fit-transaminases * Tbenġil fis-sit tal-injezzjoni, Ematoma fis-sit tal-injezzjoni, Ħruq fis-sit tal-injezzjoni, Eritema fis-sit talinjezzjoni, Ipoesteżija fis-sit tal-injezzjoni, Irritazzjoni fis-sit tal-injezzjoni, Nuqqas ta' sensazzjoni fis-sit talinjezzjoni, Edima fis-sit tal-injezzjoni, Uġigħ fis-sit tal-injezzjoni, Sensazzjoni ta' pressjoni fis-sit talinjezzjoni, Ħakk fis-sit tal-injezzjoni, Nefħa fis-sit tal-injezzjoni, Urtikarja fis-sit tal-injezzjoni, u Sħana fis-sit tal-injezzjoni.
English: Not known (frequency cannot be estimated from the available data) : Hives (urticaria)
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli): Ħorriqija (urtikarja)
English: Icatibant was not teratogenic when administered by SC injection during early embryonic and fetal development in rat (top dose 25 mg/kg/day) and rabbit (top dose 10 mg/kg/day).
Maltese: Icatibant ma kienx teratoġeniku meta ngħata b'injezzjoni taħt il-ġilda waqt l-iżvilupp bikri ta' lembriju u tal-fetu fil-far (doża massima 25 mg/kg/kuljum) u l-fenek (doża massima 10 mg/kg/kuljum).
English: Icatibant did not elicit any cardiac conduction change in vitro (hERG channel) or in vivo in normal dogs or in various dog models (ventricular pacing, physical exertion and coronary ligation) where no associated hemodynamic changes were observed.
Maltese: Icatibant ma ġab ebda tibdil fil-konduzzjoni kardijaka in vitro (kanal hERG) jew in vivo fi klieb normali jew f'diversi mudelli ta' klieb (pass ventrikolari, sforz fiżiku u rabta koronarja) meta ma ġie osservat l-ebda tibdil ħemodinamiku relatat.
English: Tabulated list of adverse reactions
Maltese: Lista tar-reazzjonijiet avversi ġo tabella
English: Refer to table 1 for dosage information.
Maltese: Irreferi għal tabella 1 għal informazzjoni dwar iddożaġġ.
English: 51 kg to 65 kg
Maltese: 51 kg sa 65 kg
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet ta' farmakoviġilanza meħtieġa u l-interventi dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Icatibant volume of distribution (Vss) is about 20-25 L. Plasma protein binding is 44%.
Maltese: It-twaħħil mal-proteini talplasma huwa ta' 44%.
English: ACE inhibitors are contraindicated in HAE patients due to possible enhancement of bradykinin levels.
Maltese: L-inibituri ACE huma kontraindikati f'pazjenti HAE minħabba żieda possibbli fil-livelli ta' bradykinin.
English: Table 2: Adverse reactions reported with icatibant
Maltese: Tabella 2: Reazzjonijiet avversi rrappurtati b'icatibant fil-provi kliniċi ta' fażi
English: The pharmacokinetic profile of icatibant in patients with HAE is similar to that in healthy volunteers.
Maltese: Il-profil farmakokinetiku ta' icatibant f'pazjenti b'HAE huwa simili għal dak f'voluntiera b'saħħithom.
English: Table 4 shows the efficacy results for FAST-3.
Maltese: It-Tabella 4 turi r-riżultati tal-effikaċja għal FAST-3.
English: 2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less 2b) Preparing the syringe and needle for injection (all patients) 3) Preparing the injection site
Maltese: 2a) Kif tħejji s-siringa għal tfal u adolexxenti (2-17-il sena) li jiżnu 65 kg jew inqas 2b) Kif tħejji s-siringa u l-labra għal injezzjoni (il-pazjenti kollha) 3) Kif tħejji s-sit tal-injezzjoni
English: Results do not indicate a carcinogenic potential for icatibant.
Maltese: Ir-riżultati ma jindikawx li hemm potenzjal karċinoġeniku għal icatibant.
English: Each ml of the solution contains 10 mg of icatibant.
Maltese: Kull 1 ml tas-soluzzjoni fih 10 mg icatibant.
English: 12 kg to 25 kg
Maltese: 12 kg sa 25 kg
English: Each 3 ml pre-filled syringe contains icatibant acetate equivalent to 30 mg icatibant.
Maltese: Kull 3 ml siringa mimlija għal-lest fiha icatibant acetate ekwivalenti għal 30 mg icatibant.
English: Patients with symptoms of laryngeal angioedema received open label treatment with icatibant.
Maltese: Il-pazjenti b'sintomi ta' anġjoedema larinġali rċevew trattament open label b'icatibant.
English: Firazyr blocks the activity of bradykinin and therefore ends the further progression of the symptoms.
Maltese: Firazyr jimblokka l-attività ta' bradykinin u għalhekk iwaqqaf il-progressjoni supplementari tassintomi ta' attakk ta' HAE.
English: Animal studies showed effects on uterine implantation and parturition (see section 5.3), but the potential risk for humans is unknown.
Maltese: Studji fuq bhejjem urew effetti fuq l-uterine implantation u t-twelid (ara sezzjoni 5.3), iżda mhux magħruf ir-riskju potenzjali fuq in-nies.
English: The primary endpoint was time to onset of symptom relief assessed using a 3-item composite visual analog score (VAS-3) consisting of assessments of skin swelling, skin pain, and abdominal pain.
Maltese: L-endpoint primarju kien ilħin sal-bidu tas-solljiev mis-sintomi ivvalutat permezz ta' skor analogu viżiv kompost ta' 3-punti (VAS-3) li kien jikkonsisti minn valutazzjonijiet ta' nefħiet tal-ġilda, uġigħ tal-ġilda u uġigħ addominali.
English: In clinical studies used for registration, a total of 999 HAE attacks have been treated with 30 mg Firazyr administered subcutaneously by a healthcare professional.
Maltese: Fi studji kliniċi użati għar-reġistrazzjoni, b'kollox ġew ikkurati 999 attakk ta' HAE bi 30 mg Firazyr mogħtija taħt il-ġilda minn professjonista tal-kura tas-saħħa.
English: All episodes (N = 56)
Maltese: L-episodji kollha (N = 56)
English: Firazyr was administered by subcutaneous injection at a dose of 0.4 mg/kg based on body weight to a maximum dose of 30 mg.
Maltese: Firazyr ingħata permezz ta' injezzjoni taħt il-ġilda f'doża ta' 0.4 mg/kg abbażi tal-piż tal-ġisem sa doża massima ta' 30 mg.
English: - You should not have more than 3 injections in a 24 hour period and if you require more than 8 injections in a month, you should seek medical advice.
Maltese: - M'għandekx tieħu aktar minn 3 injezzjonijiet f'perjodu ta'24 siegħa u jekk għandek bżonn aktar minn 8 injezzjonijiet addizzjonali f'xahar, għandek tfittex parir mediku.
English: The efficacy population consisted of 22 patients who had been treated with icatibant (11 prepubertal and 11 pubertal/postpubertal) for HAE attack.
Maltese: Il-popolazzjoni tal-effikaċja kkonsistiet minn 22 pazjent li ġew ikkurati b'icatibant (11 fl-età ta' qabel il-pubertà u 11 fl-età ta' pubertà/ta' wara l-pubertà) għall-attakk tal-HAE.
English: 26 kg to 40 kg
Maltese: 26 kg sa 40 kg
English: 41 kg to 50 kg
Maltese: 41 kg sa 50 kg
English: Additional injection site reactions (pressure sensation, bruising, reduced sensation and/or numbness, raised itchy skin rash and warmth).
Maltese: Reazzjonijiet oħra fil-punt ta' l-injezzjoni (sensazzjoni ta' pressjoni, tbenġil, sensazzjoni mnaqqsa u/jew truxija, raxx imqajjem tal-ġilda bil-ħakk u sħana).
English: Injection Volume
Maltese: U KWANTITATTIVA
English: Fatigue, lethargy, tiredness, somnolence, and dizziness have been reported following the use of Firazyr.
Maltese: Għeja, letarġija, ngħas, u sturdament ġew irrappurtati wara l-użu ta' Firazyr.
English: Limited information is available on patients older than 65 years of age.
Maltese: Hemm informazzjoni limitata dwar pazjenti ta' 'l fuq minn 65 sena.
English: The majority of paediatric patients who were treated with subcutaneous icatibant experienced injection site reactions such as erythema, swelling, burning sensation, skin pain and itching/pruritus; these were found to be mild to moderate in severity and consistent with reactions that have been reported in adults.
Maltese: Il-maġġoranza tal-pazjenti pedjatriċi li ġew ikkurati b'icatibant taħt il-ġilda esperjenzaw reazzjonijiet fis-sit tal-injezzjoni bħal eritema, nefħa, sensazzjoni ta' ħruq, uġigħ fil-ġilda u ħakk; dawn instabu li kienu ħfief sa moderati fis-severità u kienu konsistenti mar-reazzjonijiet li ġew irrappurtati fl-adulti.
English: • Hold syringe between 45-90 degrees angle to skin with needle facing the skin.
Maltese: • Żomm is-siringa f'angolu ta' bejn 45-90 grad mal-ġilda bil-labra tħares lejn il-ġilda.
English: (Unknown)
Maltese: (Mhux magħruf)
English: No more than 3 injections of Firazyr should be administered in a 24 hour period.
Maltese: M'għandhomx jingħataw aktar minn 3 injezzjonijiet ta' Firazyr f'perjodu ta' 24 siegħa.
English: Solution for injection One pre-filled syringe One 25G needle
Maltese: U KONTENUT Soluzzjoni għal injezzjoni Siringa waħda mimlija għal-lest Labra waħda ta' 25G
English: What is in this leaflet:
Maltese: Apparti minn hekk:
English: Adrenal gland hypertrophy was observed at all doses tested in rats.
Maltese: Ġiet osservata ipertrofija tal-glandoli adrenali fid-dożi kollha ttestjati fil-firien.
English: The terminal plasma half-life is about 1-2 hours.
Maltese: Il-half-life terminali tal-plasma hija ta' madwar siegħa sa sagħtejn.
English: Avoid touching the ends of the connector and syringe tips, to prevent contamination
Maltese: Evita li tmiss it-truf tal-konnettur u t-truf tas-siringa, sabiex tipprevjeni lkontaminazzjoni
English: How to use Firazyr
Maltese: X'fih Firazyr
English: Hepatic and Renal Impairment Limited data suggest that icatibant exposure is not influenced by hepatic or renal impairment.
Maltese: Id-dejta limitata turi li l-esponiment għal icatibant mhuwiex influwenzat minn indeboliment epatiku jew tal-kliewi.
English: Firazyr 30 mg solution for injection in pre-filled syringe Icatibant
Maltese: Firazyr 30 mg soluzzjoni għal injezzjoni siringa mimlija għal-lest Icatibant
English: Icatibant had no effect on the fertility of male mice (top dose 80.8 mg/kg/day) and rats (top dose 10 mg/kg/day).
Maltese: 8 mg/kg/kuljum) u firien (l-ogħla doża ta' 10 mg/kg/kuljum).
English: Clearance is about 15-20 l/h and independent of dose.
Maltese: It-tneħħija hija madwar 15-20 litru/siegħa u hija indipendenti middoża.
English: If you are taking a medicine known as an Angiotensin Converting Enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril) which is used to lower your blood pressure or for any other reason, you should inform your doctor before receiving Firazyr.
Maltese: Jekk qed tieħu mediċina magħrufa bħala inibitur ta' l-Angiotensin Converting Enzyme (ACE) (per eżempju: captopril, enalapril, ramipril, quinapril, lisinopril) li tintuża biex tbaxxi l-pressjoni tad-demm tiegħek jew għal xi raġuni oħra, inti għandek tinforma lit-tabib tiegħek qabel tirċievi Firazyr.
English: Adrenal gland hypertrophy was seen to reverse after cessation of icatibant treatment.
Maltese: III kkontrollati, f'każijiet rari ġiet osservata pożittività temporanja għal antikorpi anti-icatibant.
English: Following a single subcutaneous administration (0.4 mg/kg up to a maximum of 30 mg), the time to maximum concentration is approximately 30 minutes and the terminal half-life is about 2 hours.
Maltese: Wara għoti taħt il-ġilda waħdieni (0.4 mg/kg sa massimu ta' 30 mg), il-ħin għallkonċentrazzjoni massima huwa madwar 30 minuta u l-half-life terminali hija ta' madwar sagħtejn.
English: Firazyr is used for treating the symptoms of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older.
Maltese: Il-pazjenti kollha (adulti, adolexxenti u tfal)
English: A dose of 3.2 mg/kg intravenously (approximately 8 times the therapeutic dose) caused transient erythema, itching, flushing or hypotension in healthy subjects.
Maltese: Doża ta' 3.2 mg/kg fil-vina (madwar 8 darbiet id-doża terapewtika) kkawżat eritema għaddiena, ħakk, vampati jew pressjoni baxxa f'individwi b'saħħithom.
English: Overall, the median time to minimal symptoms (earliest time post treatment when all symptoms were either mild or absent) was 1.1 hours (95% confidence interval, 1.0-2.0 hours).
Maltese: B'mod globali, il-ħin medjan għas-sintomi minimi (l-aktar ħin bikri wara l-kura meta s-sintomi kollha kienu jew ħfief jew assenti) kien 1.1 sigħat (95 % intervall ta' fiduċja, 1.0-2.0 sigħat).
English: EU/1/08/461/001 EU/1/08/461/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/461/002
English: Icatibant had no effect on the fertility of male mice and rats (see section 5.3).
Maltese: Icatibant ma kellu ebda effett fuq il-fertilità ta' ġrieden u firien irġiel (ara sezzjoni 5.3).
English: Rash Erythema Pruritus
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONI RIGWARD ILPROVVISTA
English: Median
Maltese: Medja
English: - The recommended dose of Firazyr is one injection (3 ml, 30 mg) injected subcutaneously (under the skin) as soon as you notice the attack of angioedema (for example increased skin swelling, particularly affecting the face and neck, or increasing tummy pain).
Maltese: - Id-doża rakkomandata ta' Firazyr hija injezzjoni waħda (3 ml, 30 mg) injettata minn taħt ilġilda malli tinnota l-attakk ta' anġjoedema (per eżempju nefħa akbar fil-ġilda, li taffettwa b'mod partikolari l-wiċċ u l-għonq, jew uġigħ ta' żaqq li jiżdied).
English: • Withdraw the required volume of icatibant solution.
Maltese: • Iġbed il-volum meħtieġ tas-soluzzjoni ta' icatibant.
English: Icatibant was shown to be a competitive antagonist when the bradykinin challenge dose was increased 4-fold.
Maltese: Icatibant intwera li huwa antagonist kompetittiv meta cchallenge dose ta' bradykinin żdiedet b'erba' darbiet.
English: Overall the median time to onset of symptom relief was 1.0 hour (95% confidence interval, 1.0-1.1 hours).
Maltese: B'mod globali, il-ħin medjan għall-bidu tas-solljev mis-sintomi kien ta' 1.0 siegħa (95 % intervall ta' fiduċja, 1.0-1.1 sigħat).
English: No hypersensitivity or anaphylactic reactions were reported with Firazyr.
Maltese: Ebda reazzjoni ta' sensittività eċċessiva jew reazzjoni anafilattika ma ġiet irrapportata b'Firazyr.
English: Co-administration of Firazyr with angiotensin-converting-enzyme (ACE) inhibitors has not been studied.
Maltese: L-għoti fl-istess ħin ta' Firazyr ma' inibituri ta' angiotensin-converting-enzyme (ACE) ma ġiex studjat.
English: Under ischemic conditions, a deterioration of cardiac function and a decrease in coronary blood flow could theoretically arise from antagonism of bradykinin receptor type 2.
Maltese: Taħt kundizzjonijiet iskemiċi, jista' teoretikament ikun hemm deterjorament tal-funzjoni tal-qalb u tnaqqis fil-fluss tad-demm koronarju minn antagoniżmu tar-riċettur tal-bradykinin ta' tip 2.
English: Caution should therefore be observed in the administration of Firazyr to patients with acute ischemic heart disease or unstable angina pectoris (see section 5.3).
Maltese: Għalhekk għandha tiġi osservata kawtela fl-għoti ta' Firazyr lil pazjenti b'mard tal-qalb iskemiku akut jew angina pectoris instabbli (ara sezzjoni 5.3).
English: In HAE increased bradykinin concentrations are the key mediator in the development of the clinical symptoms.
Maltese: F'HAE, konċentrazzjonijiet akbar ta' bradykinin huma l-medjatur prinċipali fliżvilupp tas-sintomi kliniċi.
English: Patients weighing more than 65 kg will use the full contents of the pre-filled syringe (3 ml).
Maltese: Pazjenti li jiżnu aktar minn 65 kg se jużaw il-kontenut kollu tas-siringa mimlija għal-lest (3 ml).
English: The primary efficacy endpoint was the time to onset of symptom relief (TOSR) measured using a composite investigator-reported symptom score.
Maltese: L-endpoint primarju tal-effikaċja kien il-ħin sal-bidu tas-solljev mis-sintomi (TOSR, time to onset of symptom relief) imkejjel bl-użu ta' punteġġ kompost tas-sintomi rrapportat mill-investigatur.
English: When and how often should you use Firazyr?
Maltese: Meta u kull kemm għandek tuża Firazyr?
English: The recommended dose of Firazyr based on body weight in children and adolescents (aged 2 to 17 years) is provided in table 1 below.
Maltese: Id-doża rakkomandata ta' Firazyr abbażi tal-piż tal-ġisem fit-tfal u fl-adolexxenti (minn età ta' sentejn sa 17-il sena) hija pprovduta f'tabella 1 ta' hawn taħt.
English: Description of selected adverse reactions
Maltese: Deskrizzjoni ta' ċertu reazzjonijiet avversi
English: Table 1: Dosage regimen for paediatric patients Body Weight
Maltese: Tabella 1: Reġimen tad-dożaġġ għal pazjenti pedjatriċi
English: Icatibant is mainly eliminated by metabolism with less than 10% of the dose eliminated in the urine as unchanged drug.
Maltese: Icatibant jitneħħa prinċipalment bil-metaboliżmu b'anqas minn 10% tad-doża tiġi mneħħija fl-awrina bħala mediċina mhux mibdula.
English: Itching
Maltese: Treddigħ
English: Eleven patients were of prepubertal status and 21 patients were either pubertal or postpubertal.
Maltese: Ħdax-il pazjent kellhom status ta' qabel il-pubertà u 21 pazjent kienu jew fl-età tal-pubertà jew fl-età ta' wara l-pubertà.
English: In these studies, patients on icatibant had a faster median time to onset of symptom relief (2.0, 2.5 and 2.0 hours, respectively) compared to tranexamic acid (12.0 hours) and placebo (4.6 and 19.8 hours).
Maltese: F'dawn l-istudji, il-pazjenti fuq icatibant kellhom ħin medjan aktar mgħaġġel għall-bidu tas-solljiev mis-sintomi (sagħtejn u sagħtejn u nofs u sagħtejn rispettivament) meta mqabbel ma l-aċidu traneksamiku (12.0-il siegħa) u l-plaċebo (4.6 u 19.8 sigħat).
English: These reactions were generally mild to moderate in severity, transient, and resolved without further intervention.
Maltese: Ġeneralment dawn ir-reazzjonijiet kienu ħfief għal moderati, għaddiena, u marru mingħajr aktar intervent.