FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, the safety and tolerability of Cinryze are similar in children, adolescents and adults.
Maltese: Kollox ma' kollox, is-sigurtà u t-tollerabilità ta' Cinryze huma simili fit-tfal, fl-adoloxxenti u f'persuni adulti.
English: Cinryze based on body weight (see section 5.1).
Maltese: Cinryze ibbażata fuq il-piż tal-ġisem (ara sezzjoni 5.1).
English: Study 0624-203: Nine subjects (age range: 6 - 11) were enrolled and received a single dose of Cinryze: 3 subjects (10 - 25 kg) received 500 Units(); 3 subjects (>25 kg) 1000 Units(), and 3
Maltese: Disa' persuni (firxa tal-età: minn 6 sa 11) ġew irreġistrati u rċevew doża waħda ta' Cinryze: 3 persuni (10 - 25 kg) irċevew 500
English: [Historically assigned potency values were relative to an in-house reference standard whereby 1 Unit (U) is equal to the mean quantity of C1 inhibitor present in 1 ml of normal human plasma.]
Maltese: [Storikament, valuri ta' potenza assenjati kienu relattivi għal standard ta' referenza “in-house" fejn 1 Unità (U) hi ugwali għall-kwantità medja ta' inibitur ta' C1 preżenti f'1 ml ta' plażma umana normali.] Standard ta' referenza internazzjonali (IU) issa ġie implimentat, fejn IU hu definit ukoll bħala l-ammont ta' inibitur ta'C1 preżenti f'1 ml ta' plażma umana normali.
English: 500 IU of C1 inhibitor in a colourless glass vial (Type I), sealed with a rubber stopper (Type I) and an aluminium seal with a plastic flip-off cap.
Maltese: IU ta' inibitur ta' C1 f'kunjett tal-ħġieġ bla kulur (Tip I), issiġillat b'tapp tal-lastku (Tip I) u siġill tal-aluminju b'għatu flip-off tal-plastik.
English: Uncommon Hyperglycaemia
Maltese: Ilma għall-injezzjonijiet
English: The mean elimination half-life of functional C1 inhibitor after administration of Cinryze was 56 hours for a single dose and 62 hours for the double dose.
Maltese: Il-medja talhalf-life tal-eliminazzjoni tal-inibitur ta' C1 funzjonali wara l-għoti ta' Cinryze kienet ta' 56 siegħa għal doża waħda u 62 siegħa għad-doża doppja.
English: Cinryze 500 IU powder and solvent for solution for injection C1 inhibitor (human)
Maltese: IU ta' trab u solvent għal soluzzjoni għall-injezzjoni Inibitur ta' C1 (uman)
English: Two powder vials.
Maltese: 2 kunjetti bit-trab,
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived C1 inhibitor product.
Maltese: Tilqim adattat (epatite A u B) għandu jiġi kkunsidrat għal pazjenti li jirċievu regolarment jew b'mod ripetut prodott ta' inibitur ta' C1 miksub mill-plażma umana.
English: • If you are allergic to C1 inhibitor or any of the other ingredients of Cinryze (listed in section 6).
Maltese: • Jekk inti allerġiku għal inibitur ta' C1 jew għal xi sustanza oħra ta' Cinryze (elenkati fissezzjoni 6).
English: 1000 IU of Cinryze within 24 hours before a medical, dental, or surgical procedure.
Maltese: IU ta' Cinryze fi żmien 24 siegħa qabel proċedura medika, dentali, jew kirurġika.
English: Mean Pharmacokinetic Parameters for Functional C1 Inhibitor Following Administration of Cinryze
Maltese: Il-medja tal-parametri farmakokinetiċi għall-inibitur ta' C1 funzjonali wara l-għoti ta' Cinryze
English: Thrombotic events have been reported in neonatal and infant subjects undergoing cardiac bypass procedures while receiving off-label high doses of another C1 inhibitor product (up to 500 Units()/kg) to prevent capillary leak syndrome.
Maltese: Avvenimenti trombotiċi ġew irrappurtati fi trabi tat-twelid u tfal żgħar li kienu qed isirulhom proċeduri ta' bypass kardijaku waqt li kienu qed jirċievu dożi għoljin off-label ta' prodott ieħor ta' inibitur ta' C1 (sa 500
English: (), or 1500 Units
Maltese: , u 1500 Unità ta'
English: Low serum C4 levels often correlate with HAE attacks.
Maltese: Livelli baxxi ta' C4 fis-serum ta' spiss jikkorrelaw ma' attakki ta' HAE.
English: Technique of intravenous injection
Maltese: Teknika ta' injezzjoni ġol-vini
English: Cinryze 500 IU powder and solvent for solution for injection
Maltese: IL-PRODOTT MEDIĊINALI Cinryze 500
English: • Cinryze should be injected intravenously (into the vein).
Maltese: • Cinryze għandu jiġi injettat minn ġo vina (ġo vina).
English: Your doctor may recommend that you consider having vaccinations against hepatitis A and B if you regularly or repeatedly receive C1 inhibitor products that have been taken from human plasma.
Maltese: It-tabib tiegħek jista' jirrakkomanda li tikkunsidra li jkollok tilqim kontra epatite A u B jekk regolarment jew b'mod ripetut tirċievi prodotti ta' inibitur ta' C1 li jkunu ttieħdu minn plażma umana.
English: • A dose of 1000 IU (two vials) of Cinryze should be injected every 3 or 4 days for routine prevention of swelling attacks.
Maltese: • Doża ta' 1,000 IU (żewġ kunjetti) ta' Cinryze għandha tiġi injettata kull 3 jew 4 ijiem għal prevenzjoni ta' rutina ta' attakki ta' nefħa.
English: Age-group <6years: For the 3 subjects less than 6 years, administration of Cinryze (500 Units or 1000 Units
Maltese: Għat-3 suġġetti ta' taħt is-6 snin, l-għoti ta' Cinryze (500 Unità jew 1000 Unità
English: • If you are experiencing a severe attack, particularly a swelling of the voice-box (larynx), or if initiation of treatment is delayed, the second 1000 IU dose may be given earlier than 60 minutes after the first dose, depending on your clinical response.
Maltese: • Għal pazjenti li jkollhom attakki larinġeali, jew jekk il-bidu tal-kura jiġi ttardjat, it-tieni doża tista' tingħata qabel ma jgħaddu 60 minuta.
English: For treatment, routine prevention and pre-procedure prevention in elderly patients, 65 years of age or older, the dose is the same as for adults.
Maltese: Għal kura, prevenzjoni ta' rutina u prevenzjoni ta' preproċedura f'pazjenti anzjani, ta' 65 sena jew aktar, id-doża hi l-istess bħal dik ta' persuni adulti.
English: Cinryze 500 IU powder for solution for injection C1 inhibitor (human)
Maltese: IU ta' trab għal soluzzjoni għall-injezzjoni Inibitur ta' C1 (uman)
English: For a dose of 1000 IU: Two powder vials, 2 solvent vials, 2 filter transfer devices, 1 disposable 10 ml syringe, 1 venipuncture set and 1 protective mat are needed.
Maltese: IU għandek bżonn żewġ kunjetti tat-trab, 2 kunjetti tassolvent, 2 tagħmir tat-trasferiment bil-filtru, siringa 1 ta' 10 ml mhux riutilizzabbli, sett 1 għal venipuntura u tvalja protettiva.
English: In addition, fewer open-label Cinryze infusions were required for treatment of HAE attacks during therapy with Cinryze compared to placebo (mean 4.7 infusions vs. 15.4 infusions or 70% reduction, p<0.0001).
Maltese: 4 infużjonijiet jew tnaqqis ta' 70%, p<0.0001).
English: Administer 1000 IU (reconstituted in 10 ml of water for injections) of Cinryze by intravenous injection (into the vein) at a rate of 1 ml per minute over 10 minutes.
Maltese: IU (rikostitwiti f'10 ml ta' ilma għall-injezzjonijiet) ta' Cinryze permezz ta' injezzjoni minn ġol-vini (ġo vina) b'rata ta' 1 ml kull minuta fuq perjodu ta' 10 minuti.
English: In clinical studies, the intravenous administration of Cinryze resulted in a significant increase in systemic levels of antigenic and functional C1 inhibitor within 1 hour after administration.
Maltese: Fi studji kliniċi, l-għoti ġol-vini ta' Cinryze rriżulta f'żieda sinifikanti fil-livelli sistemiċi ta' inibitur ta' C1 antiġeniċi u funzjonali fi żmien siegħa wara l-għoti.
English: Make sure all the powder is completely dissolved.
Maltese: Aċċerta ruħek li t-trab kollu jkun inħall kompletament.
English: Prevention of swelling attacks prior to surgery
Maltese: Prevenzjoni ta' attakki ta' nefħa qabel operazzjoni
English: Adverse reactions reported in clinical studies and in postmarketing reports
Maltese: Reazzjonijiet avversi rrappurtati fl-istudji kliniċi u f'rapporti ta' wara t-tqegħid fis-suq
English: Study LEVP 2006-1: Twenty-two paediatric subjects were treated for 121 acute HAE attacks.
Maltese: Tnejn u għoxrin persuna pedjatrika ġew ikkurati għal 121 attakk akut tal-HAE.
English: The maximum serum concentration (Cmax) and area under the serum concentration-time curve (AUC) appeared to increase from the single to double dose, although the increase was not dose-proportional.
Maltese: Il-massimu tal-konċentrazzjoni fis-serum (Cmax) u ż-żona taħt il-kurva ta' konċentrazzjoni-ħin (AUC) tas-serum dehret li tiżdied middoża waħda għad-doża doppja, għalkemm iż-żieda ma kinitx proporzjonali mad-doża.
English: A second dose of 500 IU may be administered if the patient has not responded adequately after 60 minutes.
Maltese: IU jekk il-pazjent ma jkunx irrisponda b'mod adegwat wara 60 minuta.
English: Two vials of reconstituted Cinryze contain 1000 IU of C1 inhibitor (human) per 10 ml, corresponding to a concentration of 100 IU/ml.
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100);
English: Baseline-corrected Cmax (U/ml)
Maltese: Cmax ikkoreġut għal-linja bażi (U/ml)
English: A post-marketing registry should be set-up with the objective to gain additional information on the safety and the use of Cinryze in the EU.
Maltese: Reġistru ta' wara t-tqegħid fis-suq għandu jiġi stabbilit bil-għan li tinkiseb informazzjoni addizzjonali dwar is-sigurtà u l-użu ta' Cinryze fl-UE.
English: • 1000 IU of Cinryze at the first sign of the onset of an angioedema attack.
Maltese: • Doża ta' 1,000 IU (żewġ kunjetti) ta' Cinryze għandha tiġi injettata mal-ewwel sinjal ta' attakk ta' nefħa.
English: 500 IU of Cinryze at the first sign of the onset of an acute attack.
Maltese: IU ta' Cinryze mal-ewwel sinjal ta' bidu ta' attakk akut.
English: Administer 1000 IU (reconstituted in 10 ml of water for injections) of Cinryze by intravenous injection at a rate of 1 ml per minute over 10 minutes.
Maltese: IU (rikostitwiti f'10 ml ta' ilma għall-injezzjonijiet) ta' Cinryze permezz ta' injezzjoni minn ġol-vini b'rata ta' 1 ml kull minuta fuq perjodu ta' 10 minuti.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Maltese: Il-pazjenti għandhom jiġu infurmati dwar sinjali bikrin ta' reazzjonijiet ta' sensittività eċċessiva li jinkludu ħorriqija, urtikarja ġeneralizzata, tagħfis fis-sider, tħarħir, pressjoni baxxa, u anafilassi.
English: After reconstitution, one vial contains 500 IU of C1 inhibitor (human) per 5 ml corresponding to a concentration of 100 IU/ml.
Maltese: IU ta' inibitur ta' C1 (uman) f'kull 5 ml, li tikkorrispondi għal konċentrazzjoni ta' 100 IU/ml.
English: A second injection of 500 IU may be given if your symptoms do not improve after 60 minutes.
Maltese: IU jekk is-sintomi tiegħek ma jitjibux wara 60 minuta.
English: Release the powder vial label by tearing down the perforated strip indicated by the inverted triangle.
Maltese: Iftaħ it-tikketta tal-kunjett bit-trab billi tiġbed l-istrixxa perforata indikata mit-triangolu maqlub.
English: This can include allergic-type reactions.
Maltese: Dan jista' jinkludi reazzjonijiet tat-tip allerġiku.
English: Injection site rash/erythema, infusion site pain, pyrexia
Maltese: Raxx/eritema fis-sit tal-injezzjoni, uġigħ fis-sit tal-infużjoni, deni
English: How to store Cinryze
Maltese: TIKKETTA TAL-KUNJETT CINRYZE
English: Study 0624-301: Six pediatric subjects (6 to 11 years of age ) were enrolled and randomized to twice weekly dosing for 12 weeks in 2 treatment sequences (500/1000 Units or 1000/500 Units
Maltese: Sitt persuni pedjatriċi (6 sa 11-il sena) ġew irreġistrati u randomizzati għal dożaġġ ta' darbtejn f'ġimgħa għal 12-il ġimgħa f'2 sekwenzi ta' kura (500/1000
English: How to take Cinryze
Maltese: X'fih Cinryze
English: Routine prevention of swelling attacks
Maltese: Prevenzjoni ta' rutina ta' attakki ta' nefħa
English: For 98% of procedures, no HAE attacks were reported within the 72 hours after the Cinryze dose.
Maltese: Għal 98% tal-proċeduri, l-ebda attakk ta' HAE ma ġie rrappurtat fi żmien it-72 siegħa wara d-doża ta' Cinryze.
English: Summary of Product Characteristics and Patient Information Leaflet for Cinryze
Maltese: Informazzjoni għall-utent Cinryze 500
English: The study demonstrated that treatment with Cinryze within 4 hours after the onset of an HAE attack resulted in a greater than 2-fold decrease in the time to beginning of unequivocal relief of the defining symptom of the HAE attack compared to placebo (median 2 hours for Cinryze vs. >4 hours for placebo, p=0.048).
Maltese: Il-perċentwali ta' persuni li kellhom bidu ta' solliev definittiv tas-sintomu li jiddefinixxi fi żmien 4 sigħat wara d-dożaġġ kien ta' 60% għal Cinryze u 42% għall-plaċebo (p=0.062). Fost il-15-il persuna kkurati b'Cinryze open-label għal attakki ta' HAE larinġeali, l-ebda waħda minnhom ma kienet teħtieġ intubazzjoni.
English: • Before you start treatment with Cinryze, it is important that you tell your doctor if you have, or have had, problems with your blood clotting (thrombotic events).
Maltese: • Qabel tibda l-kura b'Cinryze, hu importanti li tgħid lit-tabib tiegħek, jekk għandek jew kellek problemi bit-tagħqid tad-demm tiegħek (avvenimenti trombotiċi).
English: The main function of serpins is to regulate the activity of serine proteases.
Maltese: Ilfunzjoni ewlenija tas-serpins hi li jirregolaw l-attività tas-serine proteases.
English: In adults, adolescents and children (aged 6 years and above), Cinryze can raise the amount of C1 inhibitor in the blood and routinely prevent swelling attacks from occurring.
Maltese: Fl-adulti, fl-adoloxxenti u fit-tfal (li jkollhom sitt snin jew aktar), Cinryze jista' jżid l-ammont ta' inibitur ta' C1 fid-demm u regolarment jipprevjeni milli jseħħu attakki ta' nefħa.
English: Based upon an animal study there is a potential thrombogenic threshold at doses greater than 200 Units
Maltese: Ibbażat fuq studju li sar fuq l-annimali, hemm potenzjal ta' limitu tromboġeniku f'dożi akbar minn 200 Unità
English: One powder vial, 1 solvent vial, 1 filter transfer device, 1 disposable 10 ml syringe, 1 venipuncture set and 1 protective mat is needed to prepare one dose of 500 IU.
Maltese: IU hemm bżonn ta' kunjett tat-trab wieħed, kunjett tassolvent 1, tagħmir tat-trasferiment bil-filtru 1, siringa 1 ta' 10 ml mhux riutilizzabbli, sett 1 għal venipuntura u tvalja protettiva.
English: 2 disposable 10 ml syringes
Maltese: .8 Effetti mhux mixtieqa
English: Place the powder vial on a flat surface.
Maltese: Hemm ukoll links għal siti elettroniċi oħra dwar mard rari u kura.
English: Further information to be collected includes data on drug exposure, adverse drug reactions, frequency of attacks, long-term safety data, use in pregnant patients with outcome of pregnancies, as well as use in the paediatric population.
Maltese: Informazzjoni addizzjonali li trid tinġabar tinkludi dejta dwar l-espożizzjoni għall-mediċina, reazzjonijiet avversi tal-mediċina, frekwenza ta' attakki, dejta dwar is-sigurtà fit-tul, l-użu f'nisa tqal flimkien mar-riżultat tat-tqala, kif ukoll lużu fil-popolazzjoni pedjatrika.
English: Statistic Firazyr
Maltese: Statistika Firazyr
English: ATC code: B06AC02.
Maltese: B06AC02.
English: D02 Y754, Ireland
Maltese: D02 Y754, L-Irlanda
English: System Organ Class (incidence category)
Maltese: Sistema ta' Klassifika tal-Organi (kategorija ta' inċidenza)
English: Date of first authorisation: 11 July 2008 Date of latest renewal: 13 March 2013
Maltese: Data tal-aħħar tiġdid: 13 ta' Marzu 2013
English: 1) General Information
Maltese: 1) Informazzjoni Ġenerali
English: The active substance is icatibant.
Maltese: Is-sustanza attiva hi icatibant.
English: Tel: +44(0)1256 894 959
Maltese: D02 Y754, L-Irlanda Tel: +44(0)1256 894 959
English: (Common, ≥1/100 to <1/10)
Maltese: (Komuni, ≥1/100 sa <1/10)
English: • Adapter (proximal and/or distal female luer lock connector/coupler)
Maltese: • Adapter (konnettur/coupler luer lock tan-nisa prossimali u/jew distali)
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); very rare (<1/10,000).
Maltese: 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).
English: Difference between treatments (95% CI, p-value)
Maltese: Differenza bejn ittrattamenti (95% CI, valur- p)
English: A hypodermic needle (25 G; 16 mm) is included in the pack.
Maltese: Labra ipodermika (25 G; 16 mm) hija inkluża fil-pakkett.
English: A total of 32 paediatric patients (8 children aged 2 to 11 years and 24 adolescents aged 12 to 17 years) with HAE were exposed to treatment with icatibant during clinical studies.
Maltese: Total ta' 32 pazjent pedjatriku (8 itfal minn età ta' sentejn sa 11-il sena u 24 adolexxent minn età ta' 12 sa 17-il sena) bl-HAE ġew esposti għal kura b'icatibant matul l-istudji kliniċi.
English: Firazyr contains the active substance icatibant.
Maltese: Firazyr fih is-sustanza attiva icatibant.
English: Dose (Injection Volume)
Maltese: Doża (Volum tal-Injezzjoni)
English: An attack usually lasts between 2 to 5 days.
Maltese: Attakk ġeneralment idum bejn 2 u 5 tijiem.
English: In vitro studies have confirmed that icatibant is not degraded by oxidative metabolic pathways and is not an inhibitor of major cytochrome P450 (CYP) isoenzymes (CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4) and is not an inducer of CYP 1A2 and 3A4.
Maltese: Studji in vitro kkonfermaw li icatibant ma jiġix degradat minn passaġġi metaboliċi ossidattivi u mhuwiex inibitur ta' isoenzimi (CYP) maġġuri taċ-ċitokromu P450 (CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, u 3A4) u mhuwiex induttur ta' CYP 1A2 u 3A4.
English: Following subcutaneous administration, the absolute bioavailability of icatibant is 97%.
Maltese: Wara għoti taħt il-ġilda, il-bijodisponibilità assoluta ta' icatibant hija 97%.
English: Response rate (%, CI) at 4 hours after start of treatment
Maltese: Rata ta' rispons (%, CI) 4 sigħat wara l-bidu tattrattament
English: Icatibant is a selective competitive antagonist at the bradykinin type 2 (B2) receptor.
Maltese: Icatibant huwa antagonist selettiv kompetittiv fir-riċettur tal-bradykinin ta' tip 2 (B2).
English: A total of 237 patients were treated with 1,386 doses of 30 mg icatibant for 1,278 attacks of acute HAE.
Maltese: Total ta' 237 pazjent ġew ikkurati b'1,386 doża ta' 30 mg icatibant għal 1.278 attakk ta' HAE akuta.
English: The pharmacokinetics of icatibant were characterized in paediatric HAE patients in study HGT-FIR086 (see section 5.1).
Maltese: Il-farmakokinetiċi ta' icatibant ġew ikkaratterizzati f'pazjenti HAE pedjatriċi fi studju HGT-FIR-086 (ara sezzjoni 5.1).
English: Shire Pharmaceuticals Ireland Limited
Maltese: OĦRAJN Shire Pharmaceuticals Ireland Limited
English: Icatibant is extensively metabolized by proteolytic enzymes to inactive metabolites that are primarily excreted in the urine.
Maltese: Icatibant huwa metabolizzat b'mod estensiv minn enzimi proteolitiċi għal metaboliti inattivi li jitneħħew primarjament fl-awrina.
English: Efficacy Results: FAST-3; Controlled Phase -- ITT population
Maltese: FAST-3; Fażi Kkontrollata -- Popolazzjoni ITT
English: FAST-3 was a randomized, placebo-controlled, parallel-group study of 98 adult patients with a median age of 36 years.
Maltese: FAST-3 kien studju ta' grupp parallel randomizzat, ikkontrollat bi plaċebo ta' 98 pazjent adult b'età medjana ta' 36 sena.
English: Available exposure data suggest no difference in the clearance between non-White (n=40) and White (n=132) subjects.
Maltese: Id-dejta disponibbli dwar lesponiment ma turi l-ebda differenza fit-tneħħija bejn individwi mhux-bojod (n=40) u bojod (n=132).
English: This leaflet was last revised in .
Maltese: DATA TA' META ĠIET RIVEDUTA
English: Pharmacokinetic drug interactions involving CYP450 are not expected (see section 5.2).
Maltese: Mhumiex mistennija interazzjonijiet farmakokinetiċi tal-mediċina li jinvolvu CYP450 (ara sezzjoni 5.2).
English: Contains: acetic acid glacial, sodium hydroxide, sodium chloride, water for injections.
Maltese: TA' EĊĊIPJENTI Fih: acetic acid glacial, sodium hydroxide, sodium chloride, ilma għall-injezzjonijiet.
English: It is a synthetic decapeptide with a structure similar to bradykinin, but with 5 non-proteinogenic amino acids.
Maltese: Huwa decapeptide sintetiku bi struttura simili għal bradykinin, iżda b'ħames aċidi amminiċi mhux proteinoġeniċi .
English: All episodes (N = 74)
Maltese: L-episodji kollha (N = 74)
English: The frequency of adverse reactions listed in Table 1 is defined using the following convention:
Maltese: Il-frekwenza tar-reazzjonijiet avversi elenkati f'Tabella 1 hija definita bl-użu tal-konvenzjoni segwenti:
English: 92.4% of these attacks of HAE were treated with a single dose of Firazyr.
Maltese: 92.4% ta' dawn l-attakki ta' HAE ġew ikkurati b'doża waħda ta' Firazyr
English: Subsequent episodes of HAE were treated in an open label extension.
Maltese: Episodji suċċessivi ta' HAE ġew trattati f'estensjoni open label.
English: In healthy young subjects, icatibant administered in doses of 0.8 mg/kg over 4 hours; 1.5 mg/kg/day or 0.15 mg/kg/day for 3 days, development of bradykinin-induced hypotension, vasodilatation and reflex tachycardia was prevented.
Maltese: F'individwi żgħażagħ b'saħħithom, icatibant mogħti f'dożi ta' 0.8 mg/kg fuq 4 sigħat; 1.5 mg/kg/kuljum jew 0.15 mg/kg/kuljum għal 3 ijiem, ġiet evitata pressjoni baxxa, vażodilazzjoni u takikardja ta' rifless indotti minn bradykinin.
English: Data suggest an age-related decline in clearance resulting in about 50-60% higher exposure in older people (75-80 years) compared to patients aged 40 years.
Maltese: Id-dejta turi tnaqqis fit-tneħħija relatata ma' l-età li tirriżulta f'madwar 50-60% iktar esponiment f'persuni akbar fl-età (bejn 75 u 80 sena) meta pparagunat ma' pazjenti ta' 40 sena.
English: Acetic acid, glacial (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Acetic acid, glacial (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH)
English: The relevance of this to the safety of Firazyr is unknown (see section 5.2).
Maltese: Mhix magħrufa r-rilevanza ta' dan għas-sigurtà ta' Firazyr (ara sezzjoni 5.2).
English: Information on individual race effect is limited.
Maltese: L-informazzjoni dwar l-effetti individwali fuq ir-razza hija limitata.
English: Children and adolescents aged 2-17 years
Maltese: Tfal u adolexxenti minn età ta' sentejn sa 17-il sena
English: Controlled Clinical Study of FIRAZYR vs Tranexamic acid or Placebo: Efficacy Results FAST-2
Maltese: Studju Kliniku Ikkontrollat ta' FIRAZYR vs Aċidu traneżamiku/Plaċebo:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTI-PACK (INCLUDING BLUE BOX)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA TA' PAKKETT MULTIPLU (INKLUŻ KAXXA BLU)
English: 3 ml of solution in a 3 ml pre-filled syringe (type I glass) with plunger stopper (bromobutyl coated with fluorocarbon polymer).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 3 ml ta' soluzzjoni f'siringa mimlija għal-lest (ħġieġ tat-tip I) ta' 3 ml b'tapp planġer (bromobutyl miksi b'polimeru tal-fluworokarbonju).
English: Baseline VAS(mm)
Maltese: Linja ta' Bażi VAS (mm)
English: The time to maximum concentration is approximately 30 minutes.
Maltese: Il-ħin għallkonċentrazzjoni massima huwa ta' madwar 30 minuta.
English: Firazyr 30 mg SC has been administered by a healthcare professional to 129 healthy subjects and 236 patients with HAE.
Maltese: Firazyr 30 mg SC ingħata minn professjonista tal-kura tas-saħħa lil 129 suġġett b'saħħtu u lil 236 pazjent b'HAE.
English: In the first 15 Firazyr treated attacks (1,114 doses for 1,030 attacks), the median times to onset of symptom relief were similar across attacks (2.0 to 2.5 hours).
Maltese: Fl-ewwel 15-il attakk trattati b'Firazyr (1,114-il doża għal 1030 attakk), il-ħinijiet medjani għall-bidu tas-solliev tas-sintomi kienu simili fl-attakki (2.0 sa 2.5 sigħat).
English: Firazyr 30 mg Icatibant sc
Maltese: Icatibant sc
English: HAE (an autosomal dominant disease) is caused by an absence or dysfunction of C1-esteraseinhibitor.
Maltese: L-HAE (marda awtosomali dominanti) hija kkawżata minn nuqqas jew disfunzjoni ta' l-inibitur esterase C1.