FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that markets Zynquista will provide information on measures to reduce the risk of diabetic ketoacidosis, including a patient alert card and guide for patients and their carers, as well as a guide for healthcare professionals, including a prescriber's checklist.
Maltese: Il-kumpanija li tqiegħed Zynquista fis-suq se tipprovdi informazzjoni dwar il-miżuri għat-tnaqqis ta' riskju ta' ketoaċidożi dijabetika, inklużi kard tat-twissija tal-pazjent u gwida għall-pazjenti u għal dawk li jieħdu ħsiebhom, kif ukoll gwida għall-professjonisti fil-qasam tal-kura tas-saħħa, inkluża lista ta' kontroll għal min jikteb ir-riċetta.
English: In the kidneys, sotagliflozin blocks SGLT2 involved in stopping glucose in the bloodstream from being passed out into the urine.
Maltese: Fil-kliewi, is-sotagliflożina timblokka l-SGLT2 involut biex iwaqqaf lill-glukożju fiċ-ċirkolazzjoni taddemm milli jingħadda fl-awrina.
English: How is Zynquista used?
Maltese: Zynquista?
English: Other common side effects (which may affect up to 1 in 10 people) include diabetic ketoacidosis, diarrhoea and genital infection in men.
Maltese: Effetti sekondarji komuni oħrajn (li jistgħu jaffettwaw sa persuna 1 minn kull 10) jinkludu ketoaċidożi dijabetika, dijarea u infezzjoni ġenitali fl-irġiel.
English: For the full list of side effects and restrictions with Zynquista, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Zynquista, ara l-fuljett ta' tagħrif.
English: Side effects reported with Zynquista are carefully evaluated and any necessary action taken to protect patients.
Maltese: Leffetti sekondarji rrappurtati b'Zynquista huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: It is used in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control blood sugar well enough.
Maltese: Jintuża f'pazjenti b'piż żejjed (indiċi tal-massa tal-ġisem ta' mill-inqas 27 kg/m2) meta l-insulina waħedha ma tikkontrollax iz-zokkor fid-demm tajjeb biżżejjed.
English: How does Zynquista work?
Maltese: Kif jintuża Zynquista?
English: The medicine should be used with precautions to reduce the risk of diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood).
Maltese: Il-mediċina għandha tintuża bi prekawzjonijiet biex jitnaqqas ir-riskju ta' ketoaċidożi dijabetika (kumplikazzjoni serja tad-dijabete b'livelli għoljin ta' ketoni fid-demm).
English: By blocking SGLT1 in the intestine, sotagliflozin delays the absorption of glucose into the blood after a meal.
Maltese: Billi timblokka SGLT1 flintestin, is-sotagliflożina iddewwem l-assorbiment ta' glukożju fid-demm wara ikla.
English: The main measure of effectiveness was the proportion of patients who had HbA1c levels less than 7.0% and no episodes of severe hypoglycaemia (low blood glucose levels) or diabetic ketoacidosis.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-proporzjon ta' pazjenti li kellhom livelli ta' HbA1c inqas minn 7.0 % u l-ebda episodju ta' ipogliċemija severa (livelli baxxi ta' glukożju fid-demm) jew ketoaċidożi dijabetika.
English: Zynquista, taken together with insulin, is effective in lowering blood glucose levels in patients with type 1 diabetes whose blood sugar is not controlled well enough with insulin alone.
Maltese: Zynquista, meħud flimkien mal-insulina, huwa effettiv fit-tnaqqis tal-livelli ta' glukożju fid-demm f'pazjenti bid-dijabete tat-tip 1 li z-zokkor fid-demm tagħhom ma jkunx ikkontrollat tajjeb biżżejjed blinsulina waħedha.
English: Zynquista was found effective at controlling blood glucose levels in 3 main studies in patients with type 1 diabetes.
Maltese: Zynquista nstab li kien effettiv fil-kontroll tal-livelli tal-glukożju fid-demm fi 3 studji ewlenin f'pazjenti bid-dijabete tat-tip 1.
English: Zynquista (sotagliflozin)
Maltese: Għaliex Zynquista ġie awtorizzat fl-UE?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1021/001 Pregabalin Zentiva 25 mg Capsule, hard
Maltese: Daqs talpakkett folja (PVC/alu) 14-il kapsula
English: Terminal half-life (t1/2ß)
Maltese: Half-life terminali (t1/2ß)
English: Maximum concentration (Cmax)
Maltese: Konċentrazzjoni massima (Cmax)
English: System Organ Class (SOC)
Maltese: Klassifika tasSistemi u talOrgani (SOC)
English: * n=18 subjects.
Maltese: * n=18-il individwu.
English: 603 (±129) mL/day
Maltese: 603 (±129) mL/jum
English: 144 (±27) µM x day
Maltese: 144 (±27) µM x jum
English: Submission of final clinical study report by 31 March 2025
Maltese: Sottomissjoni tarrapport finali talistudju kliniku sal-31 ta' Marzu 2025
English: 5.1 (±2.4) days
Maltese: 5.1 (±2.4) jum
English: Urticaria, rash (including exfoliative and generalized)
Maltese: Urtikarja, raxx (inkluż bil-qxur u ġeneralizzat)
English: Date of first authorisation: 20 August 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Awwissu 2015
English: Respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null,null), PiSZ).
Maltese: Respreeza huwa indikat bħala kura ta' manteniment, biex inaqqas il-progressjoni tal-emfisema f'adulti b'defiċjenza severa dokumentata ta' inibitur alpha1 ta' proteinase (eż. ġenotipi PiZZ, PiZ (null), Pi (null, null), PiSZ).
English: *Produced from the plasma of human donors.
Maltese: *Magħmul mill-plażma ta' donaturi umani.
English: Respreeza contains sodium
Maltese: Respreeza fih sodium
English: CSL Behring GmbH, 35041 Marburg, Germany
Maltese: CSL Behring GmbH, 35041 Marburg, il-Ġermanja
English: The subjects ranged in age from 29 to 68 years (median age 49 years).
Maltese: L-individwi varjaw fl-età minn 29 sa 68 sena (età medjana ta' 49 sena).
English: Frequency per patient (based on six months of exposure during clinical trials) has been evaluated according to the following convention: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Maltese: Il-frekwenza għal kull pazjent (ibbażata fuq sitt xhur ta' espożizzjoni waqt provi kliniċi) ġiet evalwata skont il-konvenzjoni li ġejja: komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000) u rari ħafna (<1/10,000).
English: Volume of distribution at steady state
Maltese: Volum ta' distribuzzjoni fi stat fiss
English: Table 1 shows the mean results for the Respreeza pharmacokinetic parameters.
Maltese: Tabella 1 turi r-riżultati medji għall-parametri farmakokinetiċi ta' Respreeza.
English: Uncommon (≥1/1,000 to
Maltese: Mhux komuni (≥1/1,000 sa <1/100)
English: The reconstituted solution has an approximate osmolality of 279 mOsmol / kg and a pH of 7.0.
Maltese: Is-soluzzjoni rikostitwita għandha osmolalità ta' madwar 279 mOsmol / kg u pH ta' 7.0.
English: België/Belgique/Belgien CSL Behring NV
Maltese: België/Belgique/Belgien CSL Behring NV Tél/Tel:
English: Frequency of ARs
Maltese: Frekwenza ta' ARs
English: The total protein content is approximately 5,500 mg per vial.
Maltese: Il-kontenut ta' proteina totali huwa madwar 5,500 mg kull kunjett.
English: Excipients with known effect Respreeza contains approximately 1.9 mg sodium per ml of reconstituted solution (81 mmol/l).
Maltese: Eċċipjenti b'effett magħruf Respreeza fih madwar 1.9 mg ta' sodium f'kull ml ta' soluzzjoni rikostitwita (81 mmol/l).
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.4).
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 (ara wkoll sezzjoni 4.4).
English: The population estimate of mean half-life was 6.8 days.
Maltese: L-istima tal-popolazzjoni tal-half-life medja kienet ta' 6.8 ijiem.
English: A double-blind, randomized, active-controlled, crossover pharmacokinetic study was conducted in 13 males and 5 females with alpha1-proteinase inhibitor deficiency, ranging in age from 36 to 66 years.
Maltese: Twettaq studju pharmakokinetiku crossover, double-blind, randomised u kkontrollat b'attiv fi 13-il raġel u 5 nisa b'defiċjenza ta' inibitur alpha1 ta' proteinase, li varjaw fl-età minn 36 sa 66 sena.
English: In case of shock, emergency medical treatment should be administered.
Maltese: F'każ ta' xokk, għandha tingħata kura medika ta' emerġenza.
English: • Total reconstitution of the powder should be obtained within 5 minutes (1 g presentation) or 10 minutes (4 g and 5 g presentation).
Maltese: • Ir-rikostituzzjoni totali tat-trab għandha tinkiseb fi żmien 5 minuti (preżentazzjoni ta' 1 g) jew 10 minuti (preżentazzjoni ta' 4 g u 5 g).
English: Table 1: Pharmacokinetic parameters for alpha1-proteinase inhibitor following a single 60 mg / kg bw dose of Respreeza Pharmacokinetic Parameter
Maltese: Tabella 1: Parametri farmakokinetiċi għall-inibitur alpha1 ta' proteinase wara doża waħda ta' 60 mg / kg bw ta' Respreeza Parametru Farmakokinetiku Medja (devjazzjoni standard)* Erja taħt il-kurva (AUC0-∞)
English: A total of 180 subjects with alpha1-proteinase inhibitor deficiency characterized by a serum alpha1-proteinase inhibitor level < 11 μM (i.e. < 50 mg/dL as determined by nephelometry) and clinical evidence of emphysema, were randomized to receive a weekly 60 mg / kg bw intravenous dose of either Respreeza (93 subjects) or placebo (87 subjects) for up to 24 months.
Maltese: Total ta' 180 individwu b'defiċjenza ta' inibitur alpha1 ta' proteinase karatterizzata minn livell ta' inibitur alpha1 ta' proteinase fis-serum ta' < 1 μM (jiġifieri < 50 mg/dL kif determinat permezz ta' nefelometrija) u b'evidenza klinika ta' emfisema, kienu randomised biex jirċievu doża fil-vini kull ġimgħa ta' 60 mg / kg bw ta' Respreeza (93 individwu) jew plaċebo (87 individwu) sa 24 xahar.
English: The annual rate of lung density decline, as measured by CT scan at total lung capacity (TLC) over 2 years was lower with Respreeza (-1.45 g/L) as compared with placebo (-2.19 g/L), reflecting a 34% reduction (p = 0.017, 1-sided).
Maltese: Ir-rata annwali ta' tnaqqis fid-densità tal-pulmun, kif imkejjel minn skan ta' CT fuq il-kapaċità totali tal-pulmun (TLC - total lung capacity) fuq sentejn kienet inqas b'Respreeza (-1.45 g/L) meta mqabbel ma' plaċebo (-2.19 g/L), li juri tnaqqis ta' 34% (p = 0.017, naħa waħda).
English: • 1°transfer set 20/20 (Mix2Vial set) for reconstitution
Maltese: • Sett wieħed 20/20 li bih tittrasferixxi (sett Mix2Vial) għar-rikostituzzjoni
English: Pharmacotherapeutic group: Antihemorrhagics, proteinase inhibitor, ATC code: B02AB02
Maltese: Sustanzi kontra l-emorraġija, inibitur ta' proteinase, Kodiċi ATC:
English: The adverse reactions (ARs) collected from six clinical studies in 221 patients and post-marketing experience are presented in the table below according to the MedDRA System organ classification (SOC and Preferred Term (PT) Level).
Maltese: Ir-reazzjonijiet avversi (ARs - adverse reactions) miġbura minn sitt studji kliniċi f'221 pazjenti u minn esperjenza ta' wara t-tqegħid fis-suq huma ppreżentati fit-tabella taħt skont il-Klassifika tas-sistemi u tal-organi MedDRA (SOC - System organ classification, u Livell ta' Terminu Ippreferut (PTPreferred Term)).
English: Respreeza contains approximately 1.9 mg (<1 mmol) sodium per ml of reconstituted solution.
Maltese: Respreeza fih madwar 1.9 mg (<1 mmol) ta' sodium f'kull ml ta' soluzzjoni rikostitwita.
English: Hypersensitivity reactions (including tachycardia, hypotension, confusion, syncope, oxygen consumption decreased and pharyngeal oedema)
Maltese: Reazzjonijiet ta' sensittività eċċessiva (li jinkludu takikardija, pressjoni baxxa, konfużjoni, sinkope, konsum ta' ossiġnu imnaqqas u edima fil-farinġi)
English: Excipients : Sodium chloride, sodium dihydrogen phosphate monohydrate, mannitol.
Maltese: Eċċipjenti: sodium chloride, sodium dihydrogen phosphate monohydrate, mannitol.
English: Frequency of Adverse Reactions (ARs) in clinical studies and post-marketing experience with Respreeza
Maltese: Frekwenza ta' Reazzjonijiet Avversi (ARs) fi studji kliniċi u waqt esperjenza ta' wara t-tqegħid fis-suqb'Respreeza
English: The reconstituted solution should be infused intravenously using a separate dedicated infusion line at an infusion rate of about 0.08 ml / kg bw/ min.
Maltese: Is-soluzzjoni rikostitwita għandha tiġi infuża fil-vini bl-użu ta' linja ta' infużjoni separata u dedikata b'rata ta' infużjoni ta' madwar 0.08 ml / kg bw/ min.
English: Solvent for Respreeza
Maltese: Solvent għal Respreeza
English: Asthenia, infusion-site reactions (including infusion site hematoma)
Maltese: Astenja, reazzjonijiet fis-sit talinfużjoni (inkluż ematoma fissit tal-infużjoni)
English: This medicine contains 1.9mg sodium perml of reconstituted solution.
Maltese: Din il-mediċina fiha 1.9mg sodium f'kullml ta' soluzzjoni rikostitwita.
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 web-portal.
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 il-portal elettroniku Ewropew tal-mediċini.
English: Respreeza 1,000 mg powder and solvent for solution for infusion Respreeza 4,000 mg powder and solvent for solution for infusion Respreeza 5,000 mg powder and solvent for solution for infusion
Maltese: Respreeza 1,000 mg trab u solvent għal soluzzjoni għall-infużjoni Respreeza 4,000 mg trab u solvent għal soluzzjoni għall-infużjoni Respreeza 5,000 mg trab u solvent għal soluzzjoni għall-infużjoni
English: Human alpha1-proteinase inhibitor
Maltese: Inibitur alpha1 ta' proteinase uman
English: The frequency of ARs during post marketing only is considered as “not known (cannot be estimated from the available data)”.
Maltese: Il-frekwenza ta' ARs wara t-tqegħid fis-suq biss hija kkunsidrata bħala “mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli)”.
English: Human alpha1-proteinase inhibitor has a molecular weight of 51 kDa and belongs to the family of serine protease inhibitors.
Maltese: Inibitur alpha1 ta' proteinase uman għandu piż molekulari ta' 51 kDa u jagħmel parti mill-familja ta' inibituri ta' serine protease.
English: How to store Respreeza 6.
Maltese: Kif taħżen Respreeza 6.
English: Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
Maltese: Il-pazjenti għandhom ikunu taħt l-aħjar kura farmakoloġika u mhux farmakoloġika u juru evidenza ta' marda progressiva tal-pulmun (eż. tbassir ta' volum ta' espirazzjoni sfurzata kull sekonda (FEV1 - forced expiratory volume per second) imnaqqas, kapaċità ta' mixi indebolita jew żieda fin-numru ta' episodji ta' rkadar) kif evalwat minn professjonist fil-kura tas-saħħa b'esperjenza fil-kura ta' defiċjenza ta' inibitur alpha1 ta' proteinase.
English: The subjects ranged in age from 31 to 67 years (median age 54 years) with average baseline alpha1-proteinase inhibitor levels of approximately 6.15 µM, and average volume-adjusted CT lung density of 47 g/L / 50 g/L for Respreeza and placebo subjects, respectively.
Maltese: L-individwi varjaw fl-età minn 31 sa 67 sena (età medjana ta' 54 sena) b'livelli medji tal-inibitur alpha1 ta' proteinase fil-linja bażi ta' madwar 6.15 μM, u medja tal-volum aġġustat tad-densità tal-pulmun permezz ta' CT ta' 47 g/L / 50 g/L għall-individwi fuq Respreeza u plaċebo, rispettivament.
English: The total protein content is approximately 1,100 mg per vial.
Maltese: Il-kontenut ta' proteina totali huwa madwar 1,100 mg kull kunjett.
English: One pack contains:
Maltese: Kull pakkett fih:
English: Dizziness may occur following the administration of Respreeza (see section 4.8).
Maltese: Wara l-għoti ta' Respreeza jista' jseħħ sturdament (ara sezzjoni 4.8).
English: Single doses of 120 mg / kg bw have been administered to 137 subjects treated with Respreeza.
Maltese: Dożi singoli ta' 120 mg / kg bw ingħataw lil 137 individwu kkurati b'Respreeza.
English: The infusion solution is normally given over about 15 minutes (about 0.08 ml of solution per kg body weight each min).
Maltese: Is-soluzzjoni għallinfużjoni normalment tingħata fuq madwar 15-il minuta (madwar 0.08 ml ta' soluzzjoni kull kg ta' piż tal-ġisem kull minuta).
English: Human alpha1-proteinase inhibitor 5,000 mg
Maltese: Inibitur alpha1 ta' proteinase uman 5,000 mg
English: Human alpha1-proteinase inhibitor 1,000 mg
Maltese: Inibitur alpha1 ta' proteinase uman 1,000 mg
English: The population pharmacokinetic analysis did not indicate that there were any significant effects of age, gender, weight, or baseline serum antigenic alpha1-proteinase inhibitor concentrations on the clearance of Respreeza.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni ma indikatx effetti sinifikanti ta' età, sess, piż, jew konċentrazzjonijiet ta' inibitur alpha1 ta' proteinase antiġeniku fis-serum fil-linja bażi fuq it-tneħħija ta' Respreeza.
English: At screening, serum alpha1-proteinase inhibitor levels were between 3.2 and 10.1 M (mean of 5.6 M).
Maltese: Waqt l-ittestjar, il-livelli ta' inibitur alpha1 ta' proteinase fis-serum kienu bejn 3.2 u 10.
English: The mean trough serum alpha1-proteinase inhibitor levels at steady state (Weeks 7-11) were maintained above 11 M.
Maltese: Il-medja tal-livelli l-aktar baxxi ta' inibitur alpha1 ta' proteinase fi stat fiss fis-serum (Ġimgħat 7-11) inżammet 'il fuq minn 11 M.
English: The mean (Standard Deviation) of the steady state trough serum alpha1-proteinase inhibitor level for Respreeza-treated subjects was 17.7 M (2.5).
Maltese: Il-medja (Devjazzjoni Standard) tal-livell l-aktar baxx ta' inibitur alpha1 ta' proteinase fi stat fiss fis-serum għall-individwi kkurati b'Respreeza kienet ta' 17.7 M (2.5).
English: Human alpha1-proteinase inhibitor is a normal constituent of human blood.
Maltese: Inibitur alpha1 ta' proteinase uman huwa kostitwenti normali tad-demm uman.
English: Human alpha1-proteinase inhibitor 4,000 mg
Maltese: Inibitur alpha1 ta' proteinase uman 4,000 mg
English: A population pharmacokinetic analysis was conducted using data from 90 Respreeza-treated subjects from the RAPID trial.
Maltese: Twettqet analiżi tal-farmakokinetika tal-popolazzjoni bl-użu ta' dejta minn 90 individwu kkurati b'Respreeza mill-prova RAPID.
English: The recommended dose of 60 mg / kg bw will take approximately 15 minutes to infuse.
Maltese: Id-doża rakkomandata ta' 60 mg / kg bw tieħu madwar 15-il minuta biex tiġi infuża.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) and for the non-enveloped hepatitis A (HAV) and parvovirus B19 virus.
Maltese: Il-miżuri meħuda huma meqjusa effettivi għall-viri li għandhom kisja fuq barra bħall-virus tal-immunodefiċjenza uman (HIV - human immunodeficiency virus), il-virus tal-epatite B (HBVhepatitis B virus) u l-virus tal-epatite Ċ (HCV - hepatitis C virus) u għall-viri li m'għandhomx kisja fuq barra bħall-virus tal-epatite A (HAV - hepatitis A virus) u l-virus parvovirus B19.
English: Do NOT take Respreeza
Maltese: TIĦUX Respreeza
English: Nine subjects received a single 60 mg / kg bw dose of Respreeza followed by a comparator product, and 9 subjects received comparator product followed by a single 60 mg / kg bw dose of Respreeza, with a wash-out period of 35 days between doses.
Maltese: Disa' individwi irċevew doża waħda ta' 60 mg / kg bw ta' Respreeza segwit minn prodott ta' paragun, u 9 individwi irċevew prodott ta' paragun segwit minn doża waħda ta' 60 mg / kg bw ta' Respreeza, b'perjodu bla mediċina ta' 35 ġurnata bejn id-dożi.
English: The measures taken are considered effective for viruses such as human immunodeficiency virus (HIV), hepatitis A virus, hepatitis B virus, hepatitis C virus, and parvovirus B19 virus.
Maltese: Il-miżuri meħuda huma meqjusa effettivi għal viri bħall-virus tal-immunodefiċjenza uman (HIVhuman immunodeficiency virus), virus tal-epatite A, virus tal-epatite B, virus tal-epatite Ċ, u virus parvovirus B19.
English: The studies investigated the effect of Respreeza on the progression of emphysema, assessed by the decline of lung density, measured by computer tomography (CT).
Maltese: L-istudji investigaw l-effett ta' Respreeza fuq il-progressjoni tal-emfisema, evalwata mit-tnaqqis fid-densità tal-pulmun, imkejjel permezz ta' tomografija kompjuterizzata (CT - computer tomography).
English: Pediatric population
Maltese: Popolazzjoni Pedjatrika
English: For detailed information regarding the administration of the reconstituted solution, see the instructions at the end of section 6.6.
Maltese: Għall-informazzjoni dettaljata dwar l-għoti tas-soluzzjoni rikostitwita, ara l-istruzzjonijiet fl-aħħar ta' sezzjoni 6.6.
English: CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Germany
Maltese: CSL Behring GmbH Emil-von-Behring-Strasse 76
English: The model predicted mean steady-state concentration was 21.8 µM after a 60 mg /kg bw / week dose.
Maltese: Il-konċentrazzjoni medja fi stat fiss ideali imbassra kienet ta' 21.8 μM wara doża ta' 60 mg /kg bw / ġimgħa.
English: If this is not possible, solutions can be stored up to 3 hours at room temperature (up to 25 °C).
Maltese: Jekk dan ma jkunx possibbli, soluzzjonijiet jistgħu jinħażnu sa 3 sigħat f'temperatura tal-kamra (sa 25°C).
English: This medicine contains the active substance human alpha1-proteinase inhibitor, which is a normal component of the blood and is found in the lung.
Maltese: Din il-mediċina fiha s-sustanza attiva inibitur alpha1 ta' proteinase uman, li huwa komponent normali tad-demm u jinstab fil-pulmun.
English: Posology The recommended dose of Respreeza is 60 mg / kg body weight (bw) administered once weekly.
Maltese: Id-doża rakkomandata ta' Respreeza hija ta' 60 mg / kg ta' piż tal-ġisem (bw - body weight) mogħtija darba fil-ġimgħa.
English: Figure 1: Changes in Lung Density (TLC) from baseline in the RAPID and RAPID Extension studies
Maltese: Figura 1: Bidliet fid-Densità tal-Pulmun (TLC) mil-linja bażi fl-istudju RAPID u l-istudju ta' Estensjoni RAPID
English: In a double-blind, controlled clinical study to evaluate the safety and biochemical efficacy of Respreeza 44 subjects were randomized to receive 60 mg / kg bw intravenous dose of Respreeza once weekly for 24 weeks.
Maltese: Fi studju kliniku double-blind u kkontrollat biex jiġu evalwati s-sigurtà u l-effikaċja bijokimika ta' Respreeza 44 individwu kienu randomised biex jirċievu doża fil-vini ta' 60 mg / kg bw ta' Respreeza darba fil-ġimgħa għal 24 ġimgħa.
English: Take the Mix2Vial set together with the blister package and vertically pierce the water for injections vial with the blue tip of the Mix2Vial set (Figure 2).
Maltese: Ħu s-sett Mix2Vial bil-pakkett b'kollox u b'mod vertikali taqqab il-kunjett tal-ilma għall-injezzjonijiet bil-ponta l-blu tassett Mix2Vial (Figura 2).
English: Four clinical studies were conducted with Respreeza in 89 subjects (59 males and 30 females) to evaluate the effect of Respreeza on serum levels of alpha1-proteinase inhibitor.
Maltese: Twettqu erba' studji kliniċi b'Respreeza f'89 individwu (59 raġel u 30 mara) biex jiġi evalwat l-effett ta' Respreeza fuq il-livelli fis-serum ta' inibitur alpha1 ta' proteinase.
English: The safety and efficacy of Respreeza in elderly patients (65 years of age or older) have not been established in specific clinical trials.
Maltese: Is-sigurtà u l-effikaċja ta' Respreeza f'pazjenti anzjani (età ta' 65 sena jew aktar) ma ġewx determinati fi provi kliniċi speċifiċi.