FrancophonIA/ELRC3.0 huggingface dataset:
English: 2 to 11 years, 10-25 kg:
Maltese: 2 sa 11-il sena, 10-25 kg:
English: tmax (hr) [median (range)]
Maltese: tmax (sigħat) [medjan (medda)]
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B and hepatitis C viruses, and for the non-enveloped hepatitis A and parvovirus B19 viruses.
Maltese: Il-miżuri li jittieħdu huma kkunsidrati li huma effettivi għal viruses enveloped bħal virus talimmunodefiċjenza umana (HIV), viruses ta' epatite B u epatite Ċ, u viruses non-enveloped ta' epatite A u parvovirus B19.
English: Store below 25ºC.
Maltese: Aħżen f'temperatura taħt 25ºC.
English: Cinryze for the pre-procedure prevention of HAE attacks Open-label Cinryze was administered within 24 hours prior to a total of 91 medical, dental, or surgical procedures across the clinical programme (40 procedures in children and 51 procedures in adults).
Maltese: Cinryze għal prevenzjoni ta' preproċedura ta' HAE Cinryze open-label ingħata fi żmien 24 siegħa qabel total ta' 91 proċedura medika, dentali, jew kirurġika matul il-programm kliniku (40 proċedura fit-tfal u 51 proċedura fuq persuni adulti).
English: Adults and adolescents (12 years and above)
Maltese: Adulti u adoloxxenti (12-il sena jew aktar)
English: Transmissible agents
Maltese: Aġenti trasmessi
English: Store below 25C.
Maltese: Aħżen f'temperatura taħt 25C.
English: 2 to 11 years, >25 kg:
Maltese: 2 sa 11-il sena, >25 kg:
English: Powder vial: sodium chloride, sucrose, sodium citrate, L-valine, L-alanine, L-threonine Solvent vial: water for injections
Maltese: Kunjett bit-trab: sodium chloride, sucrose, sodium citrate, L-valine, L-alanine, L-threonine Kunjett bis-solvent: ilma għall-injezzjonijiet
English: Uncommon Joint swelling, arthralgia, myalgia
Maltese: Nefħa fil-ġogi, artralġja, mijalġja
English: Each vial of Cinryze contains approximately 11.5 mg of sodium.
Maltese: Kull kunjett ta' Cinryze fih madwar 11.5 mg ta' sodium.
English: Elimination half-life (hr)
Maltese: Half-life (h) tal-eliminazzjoni (sigħat)
English: Shire International Licensing B.V. Strawinskylaan 481
Maltese: Strawinskylaan 481
English: Do not take Cinryze
Maltese: Tiħux Cinryze
English: Adverse reaction frequencies were estimated from 2 pivotal placebo-controlled and 2 open-label studies in 251 unique subjects.
Maltese: Il-frekwenzi tar-reazzjonijiet avversi ġew stmati minn 2 studji pivitali kkontrollati bil-plaċebo u 2 studji open-label f'251 individwu uniku.
English: Across clinical studies, there were 61 unique paediatric subjects enrolled and exposed to over 2,500 infusions of Cinryze (2-5 years, n=3; 6-11 years, n=32; 12-17 years, n=26).
Maltese: Fi studji kliniċi, kien hemm 61 pazjent pedjatriku uniku li ġew irreġistrati fl-istudju u li ġew esposti għal aktar minn 2,500 infużjoni ta' Cinryze (minn sentejn sa 5 snin, n=3; 6-11-il sena, n=32; 12-17il sena, n=26).
English: Adverse reactions to treatment with Cinryze are classified by MedDRA System Organ Class and absolute frequency in Table 1.
Maltese: Ir-reazzjonijiet avversi għal kura b'Cinryze huma kklassifikati skont isl-Sistema tal-Klassifika talOrgani MedDRA u l-frekwenza assoluta f'Tabella 1.
English: There was a statistically significant (p=0.0017) difference in the changes in mean values from baseline between treatment groups at 12 hours, demonstrating the association of Cinryze treatment with an increase in C4 activity (Cinryze + 2.9 mg/dl versus placebo + 0.1 mg/dl).
Maltese: Kien hemm differenza statistikament sinifikanti (p=0.0017) fit-tibdil tal-valuri medji mil-linja bażi bejn il-gruppi tal-kura wara 12-il siegħa, li turi r-rabta tal-kura b'Cinryze ma' żieda fl-attività ta' C4 (Cinryze + 2.9 mg/dl kontra plaċebo + 0.1 mg/dl).
English: AUC(0-t) (U*hr/ml)
Maltese: AUC(0-t) (U*sigħat/ml)
English: Routine prevention of angioedema attacks
Maltese: Prevenzjoni ta' rutina ta' attakki anġjoedema
English: Frequencies are defined as 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), and not known (cannot be estimated from the available data).
Maltese: rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), u mhux magħruf (ma tistax tittieħed stima middata disponibbli).
English: The active substance is C1 inhibitor produced from the plasma of human donors.
Maltese: Is-sustanza attiva hi inibitur ta' C1 magħmul mill-plażma ta' donaturi umani.
English: Uncommon side effects (may affect up to 1 in 100 people): high blood sugar, blood clot, painful veins, hot flush, cough, stomach pain, diarrhoea, skin flaking, joint swelling and pain, muscle pain, and chest discomfort.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna): livell għoli ta' zokkor, emboli tad-demm, uġigħ fil-vini, fwawar, sogħla, uġigħ fl-istonku, dijarea, qxur fil-ġilda, nefħa u wġigħ fil-ġogi, uġigħ fil-muskoli, u skonfort fis-sider.
English: Study LEVP 2005-1/A used a randomised, double-blind, placebo-controlled, parallel group design; 71 subjects with acute HAE attacks were randomised (36 Cinryze, 35 placebo).
Maltese: Studju LEVP 2005-1/A uża metodu li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bi plaċebo, grupp parallel; 71 persuna b'attakki akuti ta' HAE ntgħażlu b'mod każwali (36 Cinryze, 35 plaċebo).
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA(I) BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Pharmacotherapeutic group: Drugs used in hereditary angioedema, C1 inhibitor, plasma derived, ATC code: B06AC01.
Maltese: Mediċini li jintużaw għal anġjoedema ereditarja, inibitur ta' C1, miksub mill-plażma, Kodiċi ATC:
English: Study LEVP 2006-4: Prior to enrollment, 23 children (age range: 3 to 17 years) reported a median monthly HAE attack rate of 3.0 (range: 0.5-28.0).
Maltese: Qabel ir-reġistrazzjoni fl-istudju, 23 tifel u tifla (medda ta' età: minn 3 sa 17il sena) irrappurtaw rata medjana ta' attakki ta' HAE kull xahar ta' 3.0 (medda: 0.5-28.0).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: 2 vials of Cinryze 500 IU powder for solution for injection 2 vials of water for injections (5 ml each) 2 filter transfer devices
Maltese: IU ta' trab għal soluzzjoni għall-injezzjoni 2 kunjetti ta' ilma għall-injezzjonijiet (5 ml kull wieħed) 2 tagħmir tat-trasferiment bil-filtru
English: PSUR Cycle
Maltese: Ċiklu ta' PSUR
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature (15C - 25C).
Maltese: Madankollu, l-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 3 sigħat fit-temperatura tal-kamra (15C - 25C).
English: C1 inhibitor is a naturally occurring protein that is normally present in the blood.
Maltese: Inibitur ta' C1 huwa proteina li teżisti fin-natura li normalment tinsab fid-demm.
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Maltese: Il-miżuri meħuda, huma kkunsidrati li huma effettivi għal viruses enveloped bħal HIV, HBV u HCV, u għal viruses non-enveloped HAV u parvovirus B19.
English: Administration of C1 inhibitor increases serum levels of C1 inhibitor activity and temporarily restores the natural regulation of the contact, complement, and fibrinolytic systems thereby controlling the swelling or the propensity to swell.
Maltese: L-għoti ta' inibitur ta' C1 iżid il-livelli fisserum tal-inibitur ta' C1 u temporanjament ireġġa' lura għan-normal ir-regolazzjoni naturali talkuntatt, u s-sistemi kumplimentari u fibrinolitiċi, u b'hekk jikkontrolla n-nefħa jew il-propensità għal nefħa.
English: Cinryze contains the human protein called “C1 inhibitor” as the active substance.
Maltese: Cinryze fih il-proteina umana msejħa “inibitur ta' C1” bħala s-sustanza attiva.
English: 5 ml of water for injections in a colourless glass vial (Type I), closed with a rubber stopper (Type I) and an aluminium seal with a plastic flip-off cap.
Maltese: 5 ml ta' ilma għall-injezzjonijiet f'kunjett tal-ħġieġ bla kulur (Tip I), magħluq b'tapp tal-lastku (Tip I) u siġill tal-aluminju b'għatu flip-off tal-plastik.
English: Angioedema attacks were also less severe during prophylactic Cinryze therapy compared to placebo (mean severity score 1.3 vs. 1.9 or a 32% reduction, p=0.0008) and of shorter duration (mean 2.1 days vs. 3.4 days or a 38% reduction, p=0.0004).
Maltese: 1.9 jew tnaqqis ta' 32%, p=0.0008) u damu inqas (medja ta' 2.1 jiem vs. 3.4 ijiem jew tnaqqis ta' 38%, p=0.0004).
English: The primary substrate of the activated C1 enzyme is C4; uninhibited C1 results in diminished C4 levels.
Maltese: Is-substrat primarju tal-enzima attivata C1 hu C4; C1 mhux inibit jirriżulta fi tnaqqis tal-livelli ta' C4.
English: Adolescents
Maltese: Adoloxxenti
English: 2 powder vials, 2 solvent vials 2 filter transfer devices 2 disposable 10 ml syringes 2 venipuncture sets 2 protective mats
Maltese: 2 tagħmir tat-trasferiment bil-filtru 2 siringi ta' 10 ml li jintremew wara li jintużaw 2 settijiet għal venipuntura 2 tvalji protettivi
English: Functional C1 inhibitor activity was measured in children in the two open label studies (see section 5.1).
Maltese: L-attività tal-inibitur ta' C1 funzjonali ġiet imkejla fi tfal f'żewġ studji open-label (ara sezzjoni 5.1).
English: Because C1 inhibitor is an endogenous human plasma protein, it is not subject to metabolism by Cytochrome P450 iso-enzymes, excretion, or pharmacokinetic drug-drug interactions exhibited by many low molecular weight compounds.
Maltese: Minħabba li l-inibitur ta' C1 hu proteina endoġena tal-plażma umana, mhuwiex suġġett għal metaboliżmu minn iżoenzimi ta' ċitokrom P450, tneħħija, jew interazzjonijiet farmakokinetiċi bejn mediċina u oħra li jiġu osservati minn ħafna komposti b'piż molekulari baxx.
English: For safety with respect to transmissible agents, see section 4.4.
Maltese: Għas-sigurtà fir-rigward ta' mediċini li jistgħu jiġu trasmessi, ara sezzjoni 4.4.
English: Both Cinryze doses resulted in relevant plasma levels of C1 INH antigen and functional activity.
Maltese: Iż-żewġ dożi ta' Cinryze rriżultaw f'livelli ta' plażma relevanti tal-antiġen ta' C1 INH u tal-attività funzjonali ta' C1 INH.
English: Venous thrombosis, phlebitis, venous burning, hot flush
Maltese: Trombożi fil-vini, flebite, ħruq fil-vini, fwawar
English: In Study 0624-301, plasma C1 INH antigen and functional activity were measured from 6 patients predose and 1h following IV administration of two dose levels of Cinryze (500 Units and 1000
Maltese: Fl-Istudju 0624-301, il-livelli fil-plażma tal-antiġen ta' C1 INH u l-attività funzjonali tiegħu tkejlu minn 6 pazjenti qabel id-doża u siegħa wara l-amministrazzjoni ġol-vini ta' żewġ livelli tad-doża ta' Cinryze (500 Unità u 1000 Unità
English: Cbaseline (U/ml)
Maltese: Clinja bażi (U/ml)
English: Prior to enrollment, subjects reported a median monthly HAE attack rate of 3.0 (range: 0.08-28.0); during therapy with prophylactic Cinryze, this rate was 0.21 (range: 0-4.56), and 86% of subjects experienced an average of ≤1 attack per month.
Maltese: 08-28.0); matul it-terapija b'Cinryze profilattiku, din ir-rata kienet ta' 0.21 (medda: 0-4.56), u 86% tal-persuni kellhom medja ta' ≤1 attakk kull xahar.
English: A doctor or nurse may prepare and inject Cinryze for you.
Maltese: Tabib jew infermiera jistgħu jippreparawlek u jinjettawlek Cinryze.
English: Powder:
Maltese: Kura:
English: Common side effects (may affect up to 1 in 10 people): hypersensitivity, dizziness, vomiting, rash, itching or redness, injection site rash or pain, fever.
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni): sensittività eċċessiva, sturdament, rimettar, raxx, ħakk jew ħmura, raxx jew uġigħ fis-sit tal-injezzjoni, deni.
English: The proportion of HAE attacks achieving unequivocal relief of the defining symptom within 4 hours after Cinryze treatment was comparable between the 22 children enrolled (age range: 2-17) and adults, with 89% and 86% of attacks achieving relief, respectively.
Maltese: Il-proporzjon ta' attakki ta' HAE li kellhom solliev definittiv tas-sintomu li jiddefinixxi fi żmien 4 sigħat wara l-kura b'Cinryze kien komparabbli bejn it-22 tifel u tifla rreġistrati fl-istudju (medda ta' età: 2-17-il sena) u persuni adulti, b'89% u 86% tal-attakki li kellhom solliev, rispettivament.
English: Increases in C1 INH antigen levels and functional activity above the baseline values at 1 hour and 24 hours post-dose were demonstrated.
Maltese: Żieda fil-livelli tal-antiġen C1 INH u l-attività funzjonali 'l fuq mill-valuri ta' riferiment ta'siegħa u 24 siegħa intwerew wara d-doża.
English: CL (ml/min)
Maltese: Tneħħija (ml/min)
English: C1 inhibitor is a single chain glycoprotein found in plasma which, in its mature state, consists of 478 amino acids with an apparent molecular weight of 105 kD.
Maltese: L-inibitur ta' C1 hi glikoproteina b'katina waħda li tinsab fil-plażma li, fl-istat matur tagħha, tkun tikkonsisti minn 478 amino acids b'piż molekulari apparenti ta' 105 kD.
English: Routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.
Maltese: Prevenzjoni ta' rutina ta' attakki ta' anġjoedema f'persuni adulti, adolexxenti u tfal (ta' 6 snin jew aktar) li jkollhom attakki rikorrenti ta' anġjoedema ereditarja (HAE) severa li huma intolleranti għal, jew mhumiex protetti biżżejjed minn kuri orali ta' prevenzjoni, jew pazjenti li jkunu mmaniġġjati b'mod inadegwat b'kura akuta ripetuta.
English: During the study while receiving Cinryze prophylaxis (1000 Units every 3 to 7 days; with the exception of a 3 year old child, receiving 500 Units() every 3 to 7 days), children in the various age subgroups experienced median monthly HAE attack rates of 0.4 (range: 0-3.4), and 87% of children reported an average of ≤1 attack per month; these results were comparable to those observed in adults.
Maltese: Unità kull 3 sa 7 ijiem), it-tfal fis-sottogruppi ta' età differenti kellhom rati medjani ta' attakki ta' HAE kull xahar ta' 0.4 (medda:0-3.4), u 87% tat-tfal irrappurtaw medja ta' ≤1 attakk kull xahar; dawn riżultati kienu komparabbli ma' dawk osservati f'persuni adulti.
English: For treatment, routine prevention and pre-procedure prevention in adolescents 12 to 17 years old, the dose is the same as for adults.
Maltese: Għal kura, prevenzjoni ta' rutina u prevenzjoni ta' preproċedura fl-adolexxenti li jkollhom minn 12 sa 17-il sena, id-doża hi l-istess bħal dik ta' persuni adulti.
English: The total number of days of swelling during prophylactic Cinryze therapy was reduced compared to placebo (mean 10.1 days vs. 29.6 days or a 66% reduction, p<0.0001).
Maltese: 1 jiem vs. 29.6 jiem jew tnaqqis ta' 66%, p<0.0001).
English: to prevent capillary leak syndrome.
Maltese: /kg) biex jiġi evitat is-sindrome ta' tnixxija kapillari.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Maltese: Miżuri standard biex jiġu evitati infezzjonijiet li jirriżultaw mill-użu ta' prodotti mediċinali ppreparati minn demm jew plażma umana jinkludu l-għażla tad-donaturi, screening ta' donazzjonijiet individwali u ta' lotts ta' plażma għal markaturi speċifiċi ta' infezzjoni, u l-inklużjoni ta' miżuri effettivi filproċess tal-manifattura għall-inattivazzjoni/tneħħija ta' viruses.
English: The subjects received either a single intravenous dose of 1000 Units or a 1000 Units dose followed by a second dose of 1000 Units
Maltese: , jew doża ta' 1000 Unità segwita mit-tieni doża ta' 1000 Unità
English: The recommended dose of Cinryze for adults, adolescents, children, the elderly, or patients suffering from kidney or liver problems is as follows:
Maltese: Id-doża rakkomandata ta' Cinryze għal persuni adulti, adolexxenti, tfal, persuni anzjani, jew pazjenti li jbatu minn problemi fil-kliewi jew problemi fil-fwied hija kif ġej:
English: Uncommon Cough
Maltese: Mhux komuni
English: Cinryze is usually injected into a vein (intravenously) by your doctor or nurse.
Maltese: Cinryze normalment jiġi injettat ġo vina mit-tabib jew mill-infermiera tiegħek.
English: Patients with known risk factors for thrombotic events (including indwelling catheters) should be monitored closely.
Maltese: Pazjenti b'fatturi magħrufa ta' riskju għal avvenimenti trombotiċi (li jinkludu kateters indwelling) għandhom jiġu mmonitorjati mill-qrib.
English: Each single-use powder vial contains 500 International Units (IU) of C1 inhibitor (human) produced from the plasma of human donors.
Maltese: Unità Internazzjonali (IU) ta' inibitur ta' C1 (uman) magħmul mill-plażma ta' donaturi umani.
English: Two additional studies evaluated plasma levels in children (6-11 years).
Maltese: Żewġ studji addizzjonali evalwaw il-livelli tal-plażma fit-tfal (611-il sena).
English: Your doctor will regularly review the preparation and administration process with you or a family member or carer.
Maltese: It-tabib tiegħek se jirrevedi regolarment lproċess ta' preparazzjoni u l-għoti miegħek jew ma' membru tal-familja jew persuna li tindokra.
English: Treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (HAE).
Maltese: Kura u prevenzjoni ta' preproċedura ta' attakki ta' anġjoedema f'persuni adulti, adoloexxenti u tfal (ta' sentejn jew aktar) li jkollhom anġjoedema ereditarja (HAE).
English: In clinical studies local reactions (described as pain, bruising, or rash at the injection/catheter site, venous burning or phlebitis) occurred in association with approximately 0.2% of infusions.
Maltese: Fl-istudji kliniċi, reazzjonijiet lokali (deskritti bħala wġigħ, tbenġil, jew raxx fis-sit tal-injezzjoni/kateter, ħruq jew flebite fil-vini) seħħew b'rabta ma' madwar 0.2% tal-infużjonijiet.
English: Mean increases from baseline in functional C1 inhibitor activity measured 1 hour post-dose in children 2 to <18 years of age ranged from 20% to 88% in Study LEVP 2006-1 (treatment) and from 22% to 46% in Study LEVP 2006-4 (prevention) compared with 21% to 66% and 25% to 32% in adults, respectively.
Maltese: Il-medja taż-żidiet mil-linja bażi fl-attività tal-inibitur ta' C1 funzjonali mkejla siegħa wara d-doża fi tfal li kellhom minn sentejn sa <18-il sena varjaw minn 20% sa 88% fi Studju LEVP 2006-1 (kura) u minn 22% sa 46% fi Studju LEVP 2006-4
English: Administration process for a dose of 1000 IU
Maltese: • It-tieni doża ta' 1000
English: CINRYZE VIAL LABEL
Maltese: Kif gћandek tieћu Cinryze
English: • 1000 IU of Cinryze within 24 hours before a medical, dental, or surgical procedure.
Maltese: • Doża ta' 1,000 IU (żewġ kunjetti) ta' Cinryze għandha tiġi injettata sa 24 siegħa qabel proċedura medika, dentali, jew kirurġika.
English: Cinryze therapy should be initiated under supervision of a physician experienced in the care of patients with hereditary angioedema (HAE).
Maltese: It-terapija b'Cinryze għandha tinbeda taħt is-superviżjoni ta' tabib b'esperjenza fil-kura ta' pazjenti b'anġjoedema ereditarja (HAE).
English: Ensure the powder vial and the solvent vial are at room temperature (15ºC - 25ºC).
Maltese: Żgura li l-kunjett bit-trab u l-kunjett bis-solvent ikunu fit-temperatura tal-kamra (15ºC - 25ºC).
English: The continued need for regular prophylaxis with Cinryze should be reviewed on a regular basis.
Maltese: Ilbżonn kontinwat għal profilassi regolari ma' Cinryze għandu jiġi evalwat fuq bażi regolari.
English: C1 inhibitor inhibits the complement system by binding C1r and C1s, two of the active enzyme subunits of the first component of the complement system (C1) in the classical pathway, as well as to mannose-binding lectin-associated serine proteases in the lectin pathway.
Maltese: L-inibitur ta' C1 jinibixxi s-sistema kumplimentari billi jwaħħal lil C1r u C1s, żewġ sottounitajiet attivi tal-enzima tal-ewwel komponent tal-sistema kumplimentari (C1) fil-passaġġ klassiku, kif ukoll billi jwaħħal ma' mannose is-serine proteases assoċjati ma' lectin fil-passaġġ tal-lectin.
English: Within 4 hours after Cinryze dosing, 87% of attacks achieved unequivocal relief of the defining symptom.
Maltese: Fi żmien 4 sigħat wara d-dożaġġ b'Cinryze, 87% tal-attakki kellhom solliev definittiv tas-sintomu li jiddefinixxi.
English: Administer 500 IU (reconstituted in 5 ml of water for injections) of Cinryze by intravenous injection at a rate of 1 ml per minute over 5 minutes.
Maltese: IU (rikostitwiti f'5 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' 5 minuti.
English: Two solvent vials.
Maltese: 2 kunjetti bis-solvent
English: Each pack of Cinryze contains:
Maltese: Kull pakkett ta' Cinryze fih:
English: ) was associated with increases in C1 INH levels and clinical efficacy in acute treatment and prevention of attacks.
Maltese: ) ġie assoċjat ma' żidiet fil-livelli ta' C1 INH u fl-effikaċja klinika fil-kura akuta u l-prevenzjoni tal-attakki.
English: • genitals
Maltese: • partijiet ġenitali
English: No maternal or embryofoetal effects of treatment were observed in reproductive studies in rats at dose levels up to 28-times the recommended human dose (1000 IU) based on an average adult body weight of 70 kg.
Maltese: Ma ġew osservati l-ebda effetti embrijufetali tal-kura fi studji dwar ir-riproduzzjoni fil-firien f'livelli ta' doża sa 28 darba tad-doża rakkomandata fil-bniedem (1000 IU) ibbażat fuq ilmedja tal-piż ta' ġisem ta' persuna adulta ta' 70 kg.
English: For 95% of attacks, clinical relief was observed and/or subjects were discharged to home within 4 hours.
Maltese: Għal 95% tal-attakki, solliev kliniku ġie osservat u/jew il-persuni ntbagħtu d-dar fi żmien 4 sigħat.
English: Baseline-corrected AUC(0-t) (U*hr/ml)
Maltese: AUC ikkoreġut għal-linja bażi (0-t) (U*sigħat/ml)
English: The mean pharmacokinetic parameters for functional C1 inhibitor derived from baseline-corrected concentration data are presented in Table 2.
Maltese: Ilmedja tal-parametri farmakokinetiċi għall-inibitur ta' C1 funzjonali miskuba minn dejta dwar ilkonċentrazzjoni kkoreġuta skont il-linja bażi qed jiġu ppreżentati f'Tabella 2.
English: In study 624-203, plasma C1 INH antigen and functional activity from 9 patients were obtained following a single IV dose of 500 Units
Maltese: Fl-Istudju 0624-203, il-livelli fil-plażma tal-antiġen ta' C1 INH u l-attività funzjonali tiegħu ta' 9 pazjenti tkejlu wara doża waħda ġol-vini ta' 500
English: In open-label study LEVP 2006-4, 146 subjects received Cinryze as HAE prophylaxis for periods ranging from 8 days to approximately 32 months (median 8 months).
Maltese: Fl-istudju open-label LEVP 2006-4, 146 persuna rċivew Cinryze bħala profilassi għal HAE għal perjodi li varjaw minn 8 ijiem għal madwar 32 xahar (medjan ta' 8 xhur).
English: Other medicines and Cinryze
Maltese: Mediċini oħra u Cinryze
English: 2 filter transfer devices, 2 disposable 10 ml syringes, 2 venipuncture sets, and 2 protective mats.
Maltese: 2 tagħmir tat-trasferiment bil-filtru, 2 siringi ta' 10 ml li jintremew wara li jintużaw, 2 settijiet għal venipuntura u 2 tvalji protettivi.