FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric Population Safety and effectiveness in the paediatric population have not been established.
Maltese: Is-sigurtà u l-effettività fil-popolazzjoni pedjatrika ma ġewx stabbiliti.
English: Tobacco smoke is an important risk factor for the development and progression of emphysema.
Maltese: Duħħan mit-tabakk huwa fattur ta' riskju importanti għall- iżvilupp u l-progressjoni ta' emfisema.
English: In a subgroup of subjects enrolled in this study (10 Respreeza-treated subjects) broncho-alveolar lavage was performed.
Maltese: F' sottogrupp ta' individwi rreġistrati f'dan l-istudju (10 individwi kkurati b'Respreeza) twettaq ħasil bronko-alveolari.
English: One-hundred forty subjects (76 Respreeza-treated subjects and 64 subjects treated with placebo in the RAPID Study) continued into the RAPID extension study and were treated with a weekly 60 mg / kg bw intravenous dose of Respreeza for up to 24 months.
Maltese: Mija u erbgħin individwu (76 indivdiwu ttrattati b'Respreeza u 64 individwu ttrattati bi plaċebo flIstudju RAPID) komplew bl-istudju ta' estensjoni RAPID u ġew ittrattati b'doża ta' Respreeza ta' 60 mg/kg piż tal-ġisem minn ġol-vina darba fil-ġimgħa sa 24 xahar.
English: Dizziness, headache
Maltese: Uġigħ fissider, sirdat, deni
English: The safety and efficacy of Respreeza in the paediatric population (below 18 years) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Respreeza fil-popolazzjoni pedjatrika (età ta' inqas minn 18-il sena) ma ġewx determinati s'issa.
English: Human alpha1-proteinase inhibitor is understood to be the primary anti-protease in the lower respiratory tract, where it inhibits neutrophil elastase (NE).
Maltese: Inibitur alpha1 ta' proteinase uman huwa mifhum li huwa l-anti-protease primarju fl-apparat respiratorju ta' isfel, fejn jinibixxi elastase tan-newtrofili (NE).
English: Invert the water for injections vial with the Mix2Vial set attached and vertically pierce the Respreeza vial with the clear tip of the Mix2Vial set (Figure 4).
Maltese: Aqleb ilkunjett tal-ilma għall-injezzjonijiet ta' taħt fuq bis-sett Mix2Vial imwaħħal miegħu u taqqab b'mod vertikali l-kunjett ta' Respreeza bil-ponta trasparenti tas-sett Mix2Vial (Figura 4).
English: There are no data concerning the effect on fertility but as alpha1-proteinase inhibitor is a normal component of human blood, no adverse effects on fertility are expected if you use Respreeza at the recommended dose.
Maltese: M'hemmx dejta dwar l-effett fuq il-fertilità iżda peress li inibitur alpha1 ta' proteinase huwa komponent normali tad-demm uman, mhux mistennija effetti avversi fuq il-fertilità jekk tuża Respreeza fid-doża rakkomandata.
English: Following the completion of the RAPID study, an analysis of achieved median alpha1-proteinase inhibitor levels and lung density decline was conducted.
Maltese: Wara li ntemm l-istudju RAPID, twettqet analiżi tal-livelli medjana ta' inibitur alpha1 ta' proteinase miksuba u tat-tnaqqis fid-densità tal-pulmun.
English: Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived proteinase inhibitors.
Maltese: Għandu jiġi kkunsidrat tilqim xieraq (epatite A u B) għall-pazjenti li jieħdu inibituri ta' proteinase derivati minn plażma uman b'mod regolari/ripetut.
English: • 1°solvent vial of 76 ml water for injections
Maltese: • Kunjett wieħed bis-solvent ta' 76 ml ilma għall-injezzjonijiet
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 ta' donaturi, iċċekkjar ta' donazzjonijiet individwali u ġabriet ta' plażma għall-markaturi speċifiċi ta' infezzjoni u l-inklużjoni ta' passi effettivi talmanifattura għall-inattivazzjoni / tneħħija ta' viri.
English: Tel: +385 1 5588297
Maltese: Marti Farm d.o.o. Tel: +385 1 5588297
English: Respreeza 5,000 mg powder and solvent for solution for infusion Respreeza 5,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.
Maltese: Respreeza 5,000 mg trab u solvent għal soluzzjoni għall-infużjoni Respreeza 5,000 mg ta' trab f'kunjett tal-ħġieġ (tip I), magħluq b'tapp tal-lastku (bromobutyl jew chlorobutyl) u siġill tal-aluminju b'għatu flip off tal-plastik.
English: Respreeza-treated subjects demonstrated a consistent pattern of slower lung density decline than those receiving placebo (see Figure 1).
Maltese: Individwi kkurati b'Respreeza wrew tendenza konsistenti ta' tnaqqis aktar bil-mod fid-densità tal-pulmun minn dawk li rċevew plaċebo (ara Figura 1).
English: • if you have been found to have a deficiency of certain blood proteins called immunoglobulin type A (IgA) and have developed antibodies against them.
Maltese: • jekk instab li għandek defiċjenza ta' ċerti proteini tad-demm imsejħa immunoglobulini tip A
English: Since human alpha1-proteinase inhibitor is an endogenous human protein, no adverse effects on fertility are expected when given at recommended doses.
Maltese: Peress li inibitur alpha1 ta' proteinase uman huwa proteina endoġena umana, mhux mistennija effetti avversi fuq il-fertilità meta dan jingħata f'dożi rakkomandati.
English: These include:
Maltese: NOTA:
English: Altered sense of touch like burning, tingling or feeling of numbness in your hands, arms, legs, or feet (paraesthesia), flushing, hives (urticaria), scaly rash and rash all over the body, physical weakness (asthenia), infusion-site reactions (such as burning, stinging, pain, swelling or redness at the infusion site (hematoma)).
Maltese: Sens tal-mess mibdul bħal ħruq, tingiż jew sensazzjoni ta' tnemnim f'idejk, dirgħajk, riġlejk, jew saqajk (parasteżija), fwawar, ħorriqija (urtikarja), raxx bil-qxur u raxx mal-ġisem kollu, dgħjufija fiżika (astenja), reazzjonijiet fis-sit tal-infużjoni (bħal ħruq, tingiż, uġigħ, nefħa jew ħmura fis-sit talinfużjoni (ematoma)).
English: CSL Behring LLC Route 50 North 1201 N. Kinzie Bradley, IL 60915
Maltese: Kinzie Bradley, IL 60915
English: Epithelial lining fluid measurements (ELF) of alpha1-proteinase inhibitor levels showed a consistent increase following treatment.
Maltese: Kejl tal-livelli ta' inibitur alpha1 ta' proteinase fil-fluwidu tal-kisja tal-epitelju (ELF) wera żieda konsistenti wara l-kura.
English: The total protein content is approximately 4,400 mg per vial.
Maltese: Il-kontenut ta' proteina totali huwa madwar 4,400 mg kull kunjett.
English: Respreeza 5,000 mg powder and solvent for solution for infusion:
Maltese: Respreeza 5,000 mg trab u solvent għal soluzzjoni għall-infużjoni:
English: Respreeza 1,000 mg powder and solvent for solution for infusion Respreeza 1,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.
Maltese: Respreeza 1,000 mg trab u solvent għal soluzzjoni għall-infużjoni Respreeza 1,000 mg ta' trab f'kunjett tal-ħġieġ (tip I), magħluq b'tapp tal-lastku (bromobutyl jew chlorobutyl) u siġill tal-aluminju b'għatu flip off tal-plastik.
English: One vial contains approximately 1,000 mg, 4,000 mg or 5,000 mg of alpha1-proteinase inhibitor.
Maltese: Is-sustanza attiva hi inibitur alpha1 ta' proteinase Kunjett wieħed fih madwar 1,000 mg, 4,000 mg jew 5,000 mg ta' inibitur alpha1 ta' proteinase
English: The decision of whether a patient is suitable for home-treatment / self-administration is made by the treating doctor, who should ensure appropriate training is provided (e.g. regarding reconstitution, use of Mix2Vial set, assembly of intravenous tubing, infusion techniques, maintenance of a treatment diary, identification of adverse reactions and measures to be taken in case such reactions occur) and the use is reviewed at regular intervals.
Maltese: Id-deċiżjoni ta' jekk il-pazjent hux adattat għall-kura d-dar / għoti mill-pazjent innifsu ssir mit-tabib li qed jikkura, li għandu jiżgura li jiġi pprovdut taħriġ xieraq (eż. rigward ir-rikostituzzjoni, l-użu tas-sett Mix2Vial, immuntar tat-tubi għall-għoti fil-vini, tekniki ta' infużjoni, żamma ta' djarju dwar il-kura, identifikazzjoni ta' reazzjonijiet avversi u miżuri li għandhom jittieħdu f'każ li jseħħu reazzjonijiet bħal dawn) u li l-użu jiġi evalwat mill-ġdid f'intervalli regolari.
English: Respreeza 4,000 mg powder and solvent for solution for infusion Respreeza 4,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.
Maltese: Respreeza 4,000 mg trab u solvent għal soluzzjoni għall-infużjoni Respreeza 4,000 mg ta' trab f'kunjett tal-ħġieġ (tip I), magħluq b'tapp tal-lastku (bromobutyl jew chlorobutyl) u siġill tal-aluminju b'għatu flip off tal-plastik.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Respreeza in all subsets of the pediatric population in chronic obstructive pulmonary disease (COPD) due to alpha1-proteinase inhibitor deficiency (see section 4.2 for information on pediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jigu ppreżentati r-riżultati tal-istudji b'Respreeza f'kull sett tal-popolazzjoni pedjatrika f'marda ostruttiva kronika tal-pulmun (COPDchronic obstructive pulmonary disease) ikkawżata minn defiċjenza ta' inibitur alpha1 ta' proteinase (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Respreeza 5,000 mg powder and solvent for solution for infusion.
Maltese: Respreeza 5,000 mg trab u solvent għal soluzzjoni għall-infużjoni.
English: Hyperhidrosis, pruritus
Maltese: Iperidrożi, ħakk
English: Respreeza 5,000 mg powder and solvent for solution for infusion 2 years
Maltese: Respreeza 5,000 mg trab u solvent għal soluzzjoni għall-infużjoni 2 snin
English: Very rarely (may affect up to 1 in 10,000 people) Decreased sense of touch like burning, tingling or feeling of numbness in your hands, arms, legs, or feet (hypoaesthesia), excessive sweating (hyperhidrosis), itching, chest pain, chills, fever (pyrexia).
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull10,000) Sens tal-mess imnaqqas bħal ħruq, tingiż jew sensazzjoni ta' tnemnim f'idejk, dirgħajk, riġlejk, jew saqajk (ipoesteżija), għaraq eċċessiv (iperidrożi), ħakk, uġigħ fis-sider, sirdat,deni.
English: Patients should be informed of signs of hypersensitivity reactions.
Maltese: Il-pazjenti għandhom ikunu infurmati dwar sinjali ta' reazzjonijiet ta' sensittività eċċessiva.
English: Respreeza 5,000 mg powder and solvent for solution for infusion One vial contains approximately 5,000 mg of human alpha1-proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase.
Maltese: Respreeza 5,000 mg trab u solvent għal soluzzjoni għall-infużjoni Kunjett wieħed fih madwar 5,000 mg ta' inibitur alpha1 ta' proteinase uman*, kif determinat millkapaċità tiegħu li jinnewtralizza elastase tan-newtrofili uman.
English: 1 solvent vial of 95 ml water for injections 1 transfer set 20/20 (Mix2Vial set) for reconstitution
Maltese: • Kunjett wieħed bis-solvent ta' 95 ml ilma għall-injezzjonijiet • Sett wieħed 20/20 li bih tittrasferixxi (sett Mix2Vial) għar-rikostituzzjoni
English: • how to keep the product sterile (aseptic infusion techniques)
Maltese: • kif iżomm il-prodott sterili (tekniki ta' infużjoni asettika)
English: ELF levels of antigenic alpha1-proteinase inhibitor and alpha1-proteinase inhibitor: NE complexes increased from baseline.
Maltese: Livelli fl-ELF ta' inibitur alpha1 ta' proteinase antiġeniku u ta' inibitur alpha1 ta' proteinase: kumplessi ta' NE żdiedu mil-linja bażi.
English: Respreeza 4,000 mg powder and solvent for solution for infusion One vial contains approximately 4,000 mg of human alpha1-proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase.
Maltese: Respreeza 4,000 mg trab u solvent għal soluzzjoni għall-infużjoni Kunjett wieħed fih madwar 4,000 mg ta' inibitur alpha1 ta' proteinase uman*, kif determinat millkapaċità tiegħu li jinnewtralizza elastase tan-newtrofili uman.
English: Respreeza 4,000 mg powder and solvent for solution for infusion:
Maltese: Respreeza 4,000 mg trab u solvent għal soluzzjoni għall-infużjoni:
English: Respreeza 4,000 mg powder and solvent for solution for infusion 2 years
Maltese: Respreeza 4,000 mg trab u solvent għal soluzzjoni għall-infużjoni 2 snin
English: No animal fertility studies have been conducted with Respreeza and its effect on human fertility has not been established in controlled clinical trials.
Maltese: Ma sarux studji dwar il-fertilità fl-annimali b'Respreeza u l-effett tiegħu fuq il-fertilità umana ma ġiex determinat fi provi kliniċi kkontrollati.
English: This medicine is used in adults with known severe alpha1-proteinase inhibitor deficiency (an inherited condition also called alpha1 antitrypsin deficiency) who have developed a lung condition called emphysema.
Maltese: Din il-mediċina tintuża f'adulti b'defiċjenza severa magħrufa tal-inibitur alpha1 ta' proteinase (kondizzjoni li tintiret imsejħa wkoll defiċjenza ta' alpha1 antitrypsin) li żviluppaw kondizzjoni talpulmun imsejħa emfisema.
English: After reconstitution with 95 ml solvent, the solution contains approximately 50 mg/ml of human alpha1-proteinase inhibitor.
Maltese: Wara r-rikostituzzjoni b'95 ml ta' solvent, is-soluzzjoni fiha madwar 50 mg/ml ta' inibitur alpha1 ta' proteinase uman.
English: Respreeza 4,000 mg powder and solvent for solution for infusion.
Maltese: Respreeza 4,000 mg trab u solvent għal soluzzjoni għall-infużjoni.
English: A total of 13 post-infusion serum samples were taken at various time points up to Day 21.
Maltese: Ittieħdu total ta' 13-il kampjun tas-serum wara l-infużjoni f'diversi punti ta' ħin sa Jum 21.
English: Some side effects may be serious: Uncommonly (may affect up to 1 in 100 people), allergic reactions have been observed.
Maltese: B'mod mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100), ġew osservati reazzjonijiet allerġiċi.
English: The other ingredients are sodium chloride, sodium dihydrogen phosphate monohydrate and mannitol (see last paragraph of section 2).
Maltese: Is-sustanzi l-oħra huma sodium chloride, sodium dihydrogen phosphate monohydrate u mannitol (ara l-aħħar paragrafu ta' sezzjoni 2).
English: Your doctor or healthcare professional will take that into consideration if you are on a controlled sodium diet.
Maltese: Dan għandu jiġi kkunsidrat f'pazjenti fuq dieta ta' sodium ikkontrollat.
English: This analysis revealed an inverse linear relationship between trough serum alpha1-proteinase inhibitor levels and the annual decline in lung density as measured by volume adjusted CT scans for subjects receiving 60 mg / kg bw intravenous dose of Respreeza.
Maltese: Din l-analiżi wriet relazzjoni lineari inversa bejn il-livelli l-aktar baxxi ta' inibitur alpha1 ta' proteinase fis-serum u t-tnaqqis ta' kull sena fid-densità tal-pulmun kif imkejjel permezz ta' skans ta' CT aġġustati għal-volum għall-individwi li rċevew doża fil-vini ta' 60 mg / kg bw ta' Respreeza.
English: Geriatric population
Maltese: Popolazzjoni ġerjatrika
English: 76 ml of water for injections in a glass vial (type I), closed with a rubber (chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.
Maltese: 76 ml ta' ilma għall-injezzjonijiet f'kunjett tal-ħġieġ (tip I), magħluq b'tapp tal-lastku (chlorobutyl) u siġill tal-aluminju b'għatu flip off tal-plastik.
English: 95 ml of water for injections in a glass vial (type I), closed with a rubber (chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.
Maltese: 95 ml ta' ilma għall-injezzjonijiet f'kunjett tal-ħġieġ (tip I), magħluq b'tapp tal-lastku (chlorobutyl) u siġill tal-aluminju b'għatu flip off tal-plastik.
English: Respreeza 1,000 mg powder and solvent for solution for infusion 3 years
Maltese: Respreeza 1,000 mg trab u solvent għal soluzzjoni għall-infużjoni 3 snin
English: Respreeza 1,000 mg powder and solvent for solution for infusion:
Maltese: Respreeza 1,000 mg trab u solvent għal soluzzjoni għall-infużjoni:
English: The recommended infusion rate given under section 4.2 should be adhered.
Maltese: Għandha tiġi segwita r-rata ta' infużjoni rakkomandata mogħtija taħt sezzjoni 4.2.
English: Use aseptic technique to transfer the reconstituted solutions into the administration container (e.g., empty intravenous bag or glass bottle; (not supplied) via a commercially available intravenous fluid tubing transfer set (not supplied)).
Maltese: Uża teknika asettika biex titrasferixxi s-soluzzjonijiet irriskostitwiti fil-kontenitur tal-għoti (eż., borża jew flixkun tal-ħġieġ vojta għall-għoti fil-vini; (mhux fornut) permezz ta' sett tat-trasferiment b'tubu għal fluwidi fil-vini disponibbli b'mod kummerċjali (mhux fornut)).
English: After reconstitution with 76 ml solvent, the solution contains approximately 50 mg/ml of human alpha1-proteinase inhibitor.
Maltese: Wara r-rikostituzzjoni b'76 ml ta' solvent, is-soluzzjoni fiha madwar 50 mg/ml ta' inibitur alpha1 ta' proteinase uman.
English: Use a separate, unused Mix2Vial set, and a water for injections vial for each Respreeza vial.
Maltese: Uża sett separat, mhux użat Mix2Vial, u kunjett tal-ilma għall-injezzjonijiet għal kull kunjett ta' Respreeza.
English: Your doctor will inform you about signs of allergic reactions (for example chills, flushing, faster heartbeat, fall in blood pressure, light-headedness, rash, hives, itching, difficulty in breathing or swallowing as well as swelling of your hands, face, or mouth) (see also section 4).
Maltese: It-tabib tiegħek se jinfurmak dwar sinjali ta' reazzjonijiet allerġiċi (per eżempju tkexkix ta' bard, fwawar, taħbit tal-qalb aktar mgħaġġel, pressjoni tad-demm titbaxxa, sturdament, raxx, ħorriqija, ħakk, diffikultà biex tieħu n-nifs jew biex tibla', kif ukoll nefħa f'idejk, wiċċek, jew ħalqek) (ara wkoll sezzjoni 4).
English: The RAPID extension study demonstrated that the reduced rate in lung density decline was maintained for subjects continuously treated with Respreeza for 4 years (see Figure 1).
Maltese: L-istudju ta' estensjoni RAPID wera li r-rata mnaqqsa ta' telf ta' densità tal-pulmun inżammet għal individwi li kienu trattati b'Respreeza kontinwament għal 4 snin (ara Figura 1).
English: Respreeza 1,000 mg powder and solvent for solution for infusion.
Maltese: Respreeza 1,000 mg trab u solvent għal soluzzjoni għall-infużjoni.
English: If more than 1 vial of Respreeza is needed to achieve the required dose, repeat instructions 1 to 11 above using an additional package containing an unused Mix2Vial set.
Maltese: Jekk ikun meħtieġ aktar minn kunjett wieħed ta' Respreeza biex tinkiseb id-doża meħtieġa, irrepeti l-istruzzjonijiet minnn 1 sa 11 t'hawn fuq bl-użu ta' pakkett addizjonali li jkun fih sett mhux użat Mix2Vial.
English: Respreeza 1,000 mg powder and solvent for solution for infusion One vial contains approximately 1,000 mg of human alpha1-proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase.
Maltese: Respreeza 1,000 mg trab u solvent għal soluzzjoni għall-infużjoni Kunjett wieħed fih madwar 1,000 mg ta' inibitur alpha1 ta' proteinase uman*, kif determinat millkapaċità tiegħu li jinnewtralizza elastase tan-newtrofili uman.
English: • if you are allergic to human alpha1-proteinase inhibitor or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġiku għal inibitur alpha1 ta' proteinase uman jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: POWDER VIAL
Maltese: TAGĦRIF
English: After reconstitution with 20 ml solvent, the solution contains approximately 50 mg/ml of human alpha1-proteinase inhibitor.
Maltese: Wara r-rikostituzzjoni b'20 ml ta' solvent, is-soluzzjoni fiha madwar 50 mg/ml ta' inibitur alpha1 ta' proteinase uman.
English: • 1°solvent vial of 20 ml water for injections
Maltese: • Kunjett wieħed ta' solvent ta' 20 ml ta' ilma għall-injezzjonijiet
English: Respreeza 5,000 mg powder and solvent for solution for infusion Human alpha1-proteinase inhibitor
Maltese: Respreeza 5,000 mg trab u solvent għal soluzzjoni għall-infużjoni Inibitur alpha1 ta' proteinase uman
English: Lymph node pain
Maltese: Kif taħżen Respreeza
English: Dyspnoea
Maltese: Ipoestesija
English: Other medicines and Respreeza
Maltese: Mediċini oħra u Respreeza
English: Follow the steps provided below for the preparation and reconstitution of Respreeza:
Maltese: Segwi l-passi pprovduti taħt għall-preparazzzjoni u r-rikostituzzjoni ta' Respreeza:
English: Hypoaesthesia
Maltese: FARMAĊEWTIKU
English: 20 ml of water for injections in a glass vial (type I), closed with a rubber (chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.
Maltese: 20 ml ta' ilma għall-injezzjonijiet f'kunjett tal-ħġieġ (tip I), magħluq b'tapp tal-lastku (chlorobutyl) u siġill tal-aluminju b'għatu flip off tal-plastik.
English: Respreeza 4,000 mg powder and solvent for solution for infusion Human alpha1-proteinase inhibitor
Maltese: Respreeza 4,000 mg trab u solvent għal soluzzjoni għall-infużjoni Inibitur alpha1 ta' proteinase uman
English: The safety and efficacy of Respreeza in elderly patients (65 years of age or older) have not been established in clinical trials.
Maltese: Is-sigurtà u l-effikaċja ta' Respreeza f'pazjenti anzjani (ta' 65 sena jew aktar) ma ġewx stabbiliti fi provi kliniċi.
English: Respreeza 1,000 mg powder for solution for infusion Human alpha1-proteinase inhibitor
Maltese: Respreeza 1,000 mg trab għal soluzzjoni għall-infużjoni Inibitur alpha1 ta' proteinase uman
English: Respreeza 5,000 mg powder for solution for infusion Human alpha1-proteinase inhibitor
Maltese: Respreeza 5,000 mg trab għal soluzzjoni għall-infużjoni Inibitur alpha1 ta' proteinase uman
English: Respreeza 1,000 mg powder and solvent for solution for infusion Human alpha1-proteinase inhibitor
Maltese: Respreeza 1,000 mg trab u solvent għal soluzzjoni għall-infużjoni Inibitur alpha1 ta' proteinase uman
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva CSL Behring LLC
English: MediSanus d.o.o.
Maltese: TĦAWDUX.
English: Open the Mix2Vial set by peeling off the lid (Figure 1).
Maltese: Iftaħ is-sett Mix2Vial billi tqaxxarlu l-għatu (Figura 1).
English: Respreeza 4,000 mg powder for solution for infusion Human alpha1-proteinase inhibitor
Maltese: Respreeza 4,000 mg trab għal soluzzjoni għall-infużjoni Inibitur alpha1 ta' proteinase uman
English: Uncommonly (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100)
English: The safety and efficacy of Respreeza was evaluated in a randomized, double-blind, placebocontrolled, multi-center study (RAPID) followed by a 2-year open-label extension study (RAPID extension study).
Maltese: Is-sigurtà u l-effikaċja ta' Respreeza kienu evalwati fi studju arbitrarju, fejn la l-individwi u lanqas ilpazjenti ma kienu jafu liema mediċina qed tingħata, ikkontrollat bi plaċebo u b'aktar minn ċentru wieħed (RAPID) segwit minn studju ta' estensjoni ta' sentejn (RAPID extension study) fejn kemm lindividwi kif ukoll il-pazjenti kienu jafu liema mediċina qed tingħata.
English: RAPID studies
Maltese: RAPID
English: • Bend the entire Mix2Vial set to the side until it disconnects from the Respreeza vial (Figure 5).
Maltese: Dawwar bil-mod il-kunjett ta' Respreeza sakemm it-trab jinħall kompletament (Figura 6).
English: 1 solvent vial of 76 ml water for injections 1 transfer set 20/20 (Mix2Vial set) for reconstitution
Maltese: Kunjett wieħed bi trab biex jintuża darba biss Kunjett wieħed bis-solvent ta' 76 ml ilma għall-injezzjonijiet Sett wieħed 20/20 li bih tittrasferixxi (sett Mix2Vial) għar-rikostituzzjoni