FrancophonIA/ELRC3.0 huggingface dataset:
English: Each dose contains 100 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution.
Maltese: Kull doża fiha 100 mikrogramma ta' ormon tal-paratirojde f'soluzzjoni ta' 71.4 mikrolitri wara rrikostituzzjoni.
English: 3 • Pick up the needle and peel the paper tab back from the needle cap (See Figure F).
Maltese: 3 • Aqbad il-labra u neħħi s-siġill tal-karta mill-għatu tal-labra (Ara Figura F).
English: • nausea and vomiting*
Maltese: • uġigħ fil-ġogi*
English: 9 • With the needle cap still pointing straight up, tap the cartridge with the tip of your fingernail 3 to 5 times, or until any large air bubbles move to the top (See Figure J).
Maltese: 9 • Bl-għatu tal-labra għadu jipponta dritt 'il fuq, tektek l-iskartoċċ bit-tarf ta' difrek għal 3 sa 5 darbiet, jew sakemm kwalunkwe bużżieqa kbira talarja titla' fil-wiċċ (Ara Figura J).
English: For any drug that affects serum calcium levels (e.g., lithium, thiazides), patients' serum calcium levels should be monitored.
Maltese: Għal kwalunkwe mediċina li taffettwa l-livelli ta' kalċju fis-serum (eż. litju, tijażidi), għandhom jiġu mmonitorjati l-livelli ta' kalċju fis-serum tal-pazjenti.
English: There are no data in patients with severe hepatic impairment.
Maltese: M'hemm l-ebda data f'pazjenti b'indeboliment epatiku sever.
English: The objective of this trial was to maintain serum calcium with Natpar while reducing or replacing oral calcium and active vitamin D. The study was a 24-week, randomised, double-blind, placebo-controlled, multicentre trial.
Maltese: L-istudju kien prova multiċentrika, ikkontrollata bi plaċebo, bi blindaġġ doppju, randomizzata fuq 24 ġimgħa.
English: Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.
Maltese: Natpar huwa indikat bħala kura aġġuntiva ta' pazjenti adulti b'ipoparatirojdiżmu kroniku li ma jistgħux jiġu kkontrollati b'mod adegwat b'terapija standard waħedha.
English: The goal of treatment with Natpar is to achieve calcaemic control and to reduce symptoms (see also section 4.4).
Maltese: L-għan tal-kura b'Natpar huwa li jintlaħaq kontroll kalċemiku u biex jitnaqqsu s-sintomi (ara wkoll sezzjoni 4.4).
English: In vitro and in vivo studies demonstrated that the clearance of Natpar is primarily a hepatic process with a lesser role played by the kidneys.
Maltese: Studji in vitro u in vivo juru li l-eliminazzjoni ta' Natpar hija prinċipalment proċess epatiku fejn ilkliewi għandhom rwol inqas importanti.
English: How to store Natpar
Maltese: Kif tibda Natpar
English: • You may want to also write down the ”Date Mixed” and “Discard On” date in a place where you will remember, like a personal calendar or mobile device.
Maltese: Nhar” f'post fejn se tiftakar, bħal kalendarju personali jew apparat mobbli.
English: Further information on Pexion can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Pexion tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This overview was last updated in May 2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Mejju 2018.
English: Pexion contains the active substance imepitoin.
Maltese: Pexion fih is-sustanza attiva imepitoin.
English: Other information about Pexion
Maltese: Informazzjoni oħra dwar Pexion
English: This compared with a reduction of 2.4 seizures to 1.1 per month with phenobarbital (another anti-epileptic medicine).
Maltese: Dan tqabbel ma' tnaqqis ta' 2.4 attakki ta' puplesija għal 1.1 fix-xahar b'phenobarbital (mediċina antiepilettika oħra).
English: The active substance in Pexion, imepitoin, is an anti-epileptic and anti-anxiety medicine.
Maltese: Is-sustanza attiva f'Pexion, imepitoin, hija mediċina antiepilettika u kontra l-ansjetà.
English: Pexion received a marketing authorisation valid throughout the EU on 25 February 2013.
Maltese: Pexion ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-25 ta' Frar 2013.
English: What are the risks associated with Pexion?
Maltese: X'inhuma r-riskji assoċjati ma' Pexion?
English: Ingestion of this medicine may cause dizziness, lethargy and nausea.
Maltese: L-inġestjoni ta' din il-mediċina tista' tikkawża sturdament, letarġija u nawsja.
English: In an EU field study looking at effects on epilepsy, Pexion at a dose of 10 to 30 mg/kg bodyweight twice daily reduced the average number of generalised seizures from 2.3 to 1.1 per month after 20 weeks of treatment.
Maltese: Fi studju fuq il-post fl-UE li ħares lejn l-effetti fuq l-epilessija, Pexion b'doża ta' 10 sa 30 mg/kg tal-piż tal-ġisem darbtejn kuljum naqqas in-numru medju ta' attakki ta' puplesija ġeneralizzati minn 2.3 għal 1.1 fix-xahar wara 20 ġimgħa ta' kura.
English: Out of 104 Pexion-treated dogs, 64% showed a good or excellent effect compared to 25% of 122 dogs receiving dummy treatment (placebo) as reported by owners.
Maltese: Minn 104 klieb ikkurati b'Pexion, 64 % urew effett tajjeb jew eċċellenti meta mqabbla ma' 25 % ta' 122 kelb li rċevew kura finta (plaċebo) kif irrappurtat mis-sidien.
English: During the evaluation phase of 12 weeks, 47% (30 out of 64) of Pexion-treated dogs were free from generalised seizures, whilst 58% (51 out of 88) of phenobarbital-treated dogs had no seizures.
Maltese: Matul il-fażi ta' evalwazzjoni ta' 12-il ġimgħa, 47 % (30 minn 64) tal-klieb ikkurati b'Pexion kienu ħielsa minn attakki ta' puplesija ġeneralizzati, filwaqt li 58 % (51 minn 88) tal-klieb ikkurati b'phenobarbital ma kellhom ebda attakk ta' puplesija.
English: In a second US field study looking at effects on epilepsy and involving 151 dogs, Pexion treatment for 12 weeks at a fixed dose of 30 mg/kg bodyweight twice daily resulted in 21% of dogs (21 out of 99) being free of generalised seizures compared to 8% of dogs (4 out of 52) given a dummy treatment.
Maltese: Fit-tieni studju fuq il-post fl-Istati Uniti li ħares lejn l-effetti fuq l-epilessija u li involva 151 kelb, il-kura b'Pexion għal 12-il ġimgħa b'doża fissa ta' 30 mg/kg tal-piż tal-ġisem darbtejn kuljum irriżultat f'21 % tal-klieb (21 minn 99) li kienu ħielsa minn attakki ta' puplesija ġeneralizzati meta mqabbla ma' 8 % talklieb (4 minn 52) li ngħataw kura finta. 25 % tal-klieb ma rrispondewx għal kura b'Pexion u kellhom listess numru jew għadd miżjud ta' attakki ta' puplesija.
English: If seizures are not adequately controlled after one week, the veterinary surgeon may increase the dose by 50 - 100% at a time, to a maximum of 30 mg per kg bodyweight twice a day.
Maltese: Jekk l-attakki ta' puplesija ma jiġux ikkontrollati b'mod adegwat wara ġimgħa, ilkirurgu veterinarju jista' jżid id-doża b'50 - 100 % waħda waħda, sa massimu ta' 30 mg għal kull kg tal-piż tal-ġisem darbtejn kuljum.
English: For epilepsy, the most common side effects with Pexion (which may affect more than 1 in 10 dogs) are ataxia (inability to coordinate muscle movements), vomiting, polyphagia (excessive eating), and somnolence (sleepiness).
Maltese: Għall-epilessija, l-effetti sekondarji l-aktar komuni b'Pexion (li jistgħu jaffettwaw aktar minn kelb 1 minn kull 10) huma atassija (nuqqas ta' ħila li jikkoordinaw movimenti tal-muskoli), rimettar, polifaġija (jieklu b'mod eċċessiv), u sonnolenza (ngħas).
English: Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other.
Maltese: Newrotrażmettituri bħal GABA huma sustanzi kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: Pexion is a veterinary medicine used in dogs to:
Maltese: Pexion huwa mediċina veterinarja li tintuża fil-klieb biex:
English: In an EU field study looking at effects on noise phobia, the effectiveness of 3 days' treatment with Pexion, at a dose of 30 mg/kg bodyweight twice daily, was investigated during New Year's Eve fireworks in dogs diagnosed with noise phobia.
Maltese: Fi studju fuq il-post fl-UE li ħares lejn l-effetti fuq fobija tal-istorbju, l-effikaċja ta' kura ta' 3 ijiem b'Pexion, b'doża ta' 30 mg/kg tal-piż tal-ġisem darbtejn kuljum, ġiet investigata waqt il-logħob tan-nar ta' lejlet l-Ewwel tas-Sena fi klieb iddijanjostikati b'fobija tal-istorbju.
English: For noise phobia, the most common side effects with Pexion (which may affect more than 1 in 10 dogs) are short-lived ataxia, increased appetite, and lethargy (lack of energy).
Maltese: Għall-fobija tal-istorbju, l-effetti sekondarji l-aktar komuni b'Pexion (li jistgħu jaffettwaw aktar minn kelb 1 minn kull 10) huma atassija li ma ddumx, żieda fl-aptit, u letarġija (nuqqas ta' enerġija).
English: Why is Pexion authorised in the EU?
Maltese: Għalfejn Pexion huwa awtorizzat fl-UE?
English: Epilepsy is caused by excessive electrical activity in the brain.
Maltese: L-epilessija tiġi kkawżata minn attività elettrika eċċessiva fil-moħħ.
English: For the full list of side effects and restrictions of Pexion, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Pexion, ara l-fuljett ta' tagħrif.
English: Imepitoin also has a weak blocking effect on calcium channels.
Maltese: Imepitoin għandu wkoll effett ta' mblokk dgħajjef fuq il-kanali tal-kalċju.
English: These are pores which let calcium move into the nerve cells allowing electrical impulses to be transmitted between nerve cells.
Maltese: Dawn huma pori li jħallu l-kalċju jimxi għal ġewwa ċ-ċelloli tan-nervituri u jippermettu lill-impulsi elettriċi biex jiġu trażmessi bejn iċ-ċelloli tan-nervituri.
English: For epilepsy, treatment with Pexion should be started at a dose of 10 mg per kg bodyweight twice a day.
Maltese: Għal epilessija, il-kura b'Pexion għandha tinbeda b'doża ta' 10 mg għal kull kg tal-piż tal-ġisem darbtejn kuljum.
English: Imepitoin partially activates the receptors for the neurotransmitter GABA, a substance that reduces electrical activity in the brain.
Maltese: Imepitoin jattiva parzjalment ir-riċetturi għannewrotrażmettitur GABA, sustanza li tnaqqas l-attività elettrika fil-moħħ.
English: • reduce anxiety and fear associated with noise phobia.
Maltese: • tnaqqas l-ansjetà u biża' assoċjati ma' fobija tal-istorbju.
English: How does Pexion work?
Maltese: Kif jintuża Pexion?
English: Therefore, Pexion should not be used as a primary treatment for dogs with cluster seizures (group of seizures occurring close together) and status epilepticus (continual seizures).
Maltese: Għalhekk, Pexion m'għandux jintuża bħala kura primarja għall-klieb b'attakki ta' puplesija f'daqqa (grupp ta' attakki ta' puplesija li jseħħu qrib xulxin) u b'epileptikus tal-istatus (attakki ta' puplesija kontinwi).
English: Even though the proportion of seizure-free dogs was lower with Pexion than with phenobarbital, some dogs were well-controlled with Pexion.
Maltese: Anki jekk ilproporzjon tal-klieb ħielsa mill-attakki ta' puplesija kien iktar baxx b'Pexion milli b'phenobarbital, xi klieb ġew ikkontrollati sew b'Pexion.
English: • reduce the frequency of generalised seizures (fits affecting most or all of the brain) due to epilepsy of unknown causes (idiopathic).
Maltese: • tnaqqas il-frekwenza ta' attakki ta' puplesija ġeneralizzati (aċċessjonijiet li jaffettwaw il-biċċa l-kbira tal-moħħ jew il-moħħ kollu) minħabba epilessija ta' kawżi mhux magħrufa (idjopatika).
English: For noise phobia, treatment with Pexion is given at a dose of 30 mg per kg bodyweight twice a day, starting 2 days before an expected noise event and continuing through it.
Maltese: Għal fobija tal-istorbju, tingħata kura b'Pexion b'doża ta' 30 mg għal kull kg tal-piż tal-ġisem darbtejn kuljum, li tibda jumejn qabel avveniment mistenni ta' storbju u tkompli matulu.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 January 2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 ta' Jannar 2017 EMA/47326/2017
English: EMA/47326/2017
Maltese: (pegfilgrastim) EMA/47326/2017
English: The active substance in Zioxtenzo, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Maltese: Is-sustanza attiva f'Zioxtenzo, pegfilgrastim, hija magħmula minn filgrastim li jkun ġie ‘pegilat' (imwaħħal ma' sustanza kimika msejħa polyethylene glycol).
English: Zioxtenzo is a medicine that contains the active substance pegfilgrastim.
Maltese: Zioxtenzo huwa mediċina li fiha s-sustanza attiva pegfilgrastim.
English: The reference medicine for Zioxtenzo is Neulasta.
Maltese: Ilmediċina ta' referenza għal Zioxtenzo hija Neulasta.
English: What is Zioxtenzo?
Maltese: Kif jaħdem Zioxtenzo?
English: On 18 January 2017, Sandoz GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zioxtenzo, intended for treating neutropenia in patients taking cancer treatments.
Maltese: Fit-18 ta' Jannar 2017, Sandoz GmbH għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għattqegħid fis-suq għal Zioxtenzo, maħsub għall-kura tan-newtropenija f'pazjenti li jieħdu kuri kontra lkanċer.
English: Zioxtenzo was developed as a ‘biosimilar' medicine.
Maltese: Zioxtenzo ġie żviluppat bħala mediċina "bijosimili".
English: What was Zioxtenzo expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Zioxtenzo?
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara d-dokument mistoqsija u tweġiba hawn.
English: Withdrawal of the marketing authorisation application for Zioxtenzo (pegfilgrastim)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Zioxtenzo (pegfilgrastim)
English: The company presented results of studies designed to show that Zioxtenzo is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Maltese: Il-kumpanija ppreżentat riżultati ta' studji li saru biex juru li Zioxtenzo huwa simili ħafna għallmediċina ta' referenza tiegħu Neulasta f'termini ta' struttura kimika, purità, il-mod kif jaħdem u l-mod kif il-ġisem juża l-mediċina.
English: granulocyte-colony-stimulating factor (G-CSF).
Maltese: Filgrastim huwa simili ħafna għal proteina tal-bniedem imsejħa fattur li jistimula l-kolonji ta' granuloċiti (G-CSF).
English: Zioxtenzo was to be used in cancer patients to treat neutropenia (low levels of neutrophils, a type of white blood cell that helps fight infection).
Maltese: Dan ifisser li kien intiż li jkun simili ħafna għal mediċina bijoloġika li diġà tinsab awtorizzata fl-Unjoni Ewropea (il-"mediċina ta' referenza").
English: The other concern was the lack of a certificate of Good Manufacturing Practice (GMP) for the medicine's manufacturing site.
Maltese: It-tħassib l-ieħor kien in-nuqqas ta' ċertifikat ta' Prassi Tajba ta' Manifattura (PTM) għas-sit ta' manifattura tal-mediċina.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had two main concerns and was of the provisional opinion that Zioxtenzo could not have been approved as a biosimilar of Neulasta.
Maltese: Fuq il-bażi tar-reviżjoni tad-data, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-idea provviżorja li Zioxtenzo ma setax jiġi approvat bħala bijosimili ta' Neulasta.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it would not be able to provide the additional data required by the CHMP within the timeframe allowed for the procedure.
Maltese: Fl-ittra li bagħtet lill-Aġenzija biex tgħarrafha bl-irtirar tal-applikazzjoni, il-kumpanija sostniet li mhux ser tkun kapaċi tipprovdi d-data addizzjonali mitluba mis-CHMP fi ħdan il-limitu ta' żmien permess għall-proċedura.
English: Because filgrastim is pegylated, its removal from the body is slowed down, allowing the medicine to be given less often.
Maltese: Minħabba li filgrastim huwa pegilat, it-tneħħija tiegħu mill-ġisem isseħħ aktar bil-mod, li tippermetti lgħoti inqas frekwenti tal-mediċina.
English: Zioxtenzo was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Maltese: Zioxtenzo kellu jintuża sabiex jitnaqqas it-tul ta' newtropenija u l-okkorrenza ta' newtropenija febbrili (newtropenja bid-deni).
English: pH: 5.0 to 6.0
Maltese: pH: 5.0 sa 6.0
English: EU/1/19/1384/002
Maltese: EU/1/19/1384/001 EU/1/19/1384/002
English: Osmolarity: 130 to 170 mOsm/kg
Maltese: Osmolarità: 130 sa 170 mOsm/kg
English: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath Ireland
Maltese: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath L-Irlanda
English: OTHER La Jolla Pharmaceutical
Maltese: La Jolla Pharmaceutical
English: 37/158 patients
Maltese: 37/158 pazjent
English: Final concentration (ng/mL)
Maltese: Konċentrazzjo ni finali (ng/mL)
English: Subgroup
Maltese: Sottogrupp
English: 114/163 patients
Maltese: 114/163 pazjent
English: 1017 CB, Amsterdam The Netherlands
Maltese: 1017 CB, Amsterdam In-Netherlands
English: Thromboembolic events
Maltese: Avvenimenti tromboemboliċi
English: Peripheral ischaemia
Maltese: Iskemija periferali
English: Median age was 64 years (range: 22-89 years).
Maltese: (medda: 22-89 sena).
English: Sodium content
Maltese: Kontenut tas-sodium
English: 28/52 patients
Maltese: 28/52 pazjent
English: 1017CB Amsterdam, Netherlands
Maltese: 1017 CB, Amsterdam
English: LIST OF EXCIPIENTS Excipients: mannitol, water for injections, sodium hydroxide, hydrochloric acid
Maltese: Eċċipjenti: mannitol, ilma għall-injezzjonijiet, sodium hydroxide, hydrochloric acid
English: Mortality through day 28 was 46% on GIAPREZA and 54% on placebo (hazard ratio 0.78; 95% confidence interval 0.57-1.07).
Maltese: Il-mortalità matul il-jum 28 kienet ta' 46 % b'GIAPREZA u 54 % bil-plaċebo (proporzjon ta' periklu 0.78; intervall ta' kunfidenza ta' 95 % 0.57-1.07).
English: Table 1:
Maltese: Tabella 1).
English: Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/10,000 to < 1/100), rare (≥ 1/10,000
Maltese: Ilkategoriji tal-frekwenza huma definiti bħala: komuni ħafna (≥ 1/10), komuni (> 1/100 sa < 1/10), mhux komuni (> 1/10,000 sa < 1/100), rari (> 1/10,000 sa < 1/1,000), u rari ħafna (< 1/10,000).
English: The median dose of GIAPREZA was 10 ng/kg/min at 30 minutes.
Maltese: Id-doża medjana ta' GIAPREZA kienet ta' 10 ng/kg/min fi 30 minuta.
English: A risk to the suckling child cannot be excluded.
Maltese: Ir-riskju gћat-tarbija li tkun qed titredda' mhux eskluż.
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac stimulants, ATC code: C01CX09
Maltese: Terapija kardijaka, stimulanti kardijaċi oħra, kodiċi ATC: C01CX09 Mekkaniżmu ta' azzjoni u effetti farmakodinamiċi
English: The recommended starting dosage of GIAPREZA is 20 nanograms (ng)/kg per minute via continuous intravenous infusion.
Maltese: Id-dożaġġ inizjali rakkomandat ta' GIAPREZA huwa 20 nanogramma (ng)/kg kull minuta permezz ta' infużjoni ġol-vini kontinwa.
English: Peripheral ischaemia a Grouped term to include arterial and venous thrombotic events b Defined as an increase in mean arterial pressure > 100 mmHg
Maltese: Iskemija periferali a Terminu ggruppat biex jinkludi avvenimenti trombotiċi arterjali u venużi b Definita bħala żieda fil-pressjoni arterjali medja > 100 mmHg
English: Store in a refrigerator (2-8 °C).
Maltese: Aħżen fi friġġ (2-8 °C).
English: Doses as low as 1.25 ng/kg per minute may be used.
Maltese: 1.25 ng/kg kull minuta.
English: Peripheral ischaemia has been reported with the use of angiotensin II (see section 4.8).
Maltese: Ġiet irrappurtata iskemija periferali bl-użu tal-anġjotensina II (ara sezzjoni 4.8).
English: GIAPREZA may be co-administered with norepinephrine, epinephrine, vasopressin, terlipressin, dopamine, and/or phenylephrine.
Maltese: GIAPREZA jista' jingħata flimkien ma' norepinephrine, epinephrine, vasopressin, terlipressin,
English: Water for injections Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Maltese: Sodium hydroxide (għall-aġġustament tal-pH) Hydrochloric acid (għall-aġġustament tal-pH)
English: The most frequent adverse reactions reported more often in the GIAPREZA arm are thromboembolic events (12.9% vs 5.1%) and transient hypertension.
Maltese: L-aktar reazzjonijiet avversi frekwenti rrappurtati aktar ta' spiss fil-fergħa ta' GIAPREZA huma avvenimenti tromboemboliċi (12.9 % kontra 5.1 %) u ipertensjoni temporanja.
English: The Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) was a Phase 3 randomised, placebo-controlled, double-blind, international, multi-centre safety and efficacy study in which 321 adults with septic or other distributive shock who remained hypotensive despite fluid and vasopressor therapy were randomised 1:1 to GIAPREZA or placebo.
Maltese: II għall-Kura ta' Xokk ta' Output Għoli (ATHOS-3) kien studju tas-sigurtà u taleffikaċja ta' Fażi 3, randomizzat, ikkontrollat bi plaċebo, double-blind, internazzjonali, multiċentriku li fih 321 adult b'xokk settiku jew distributtiv ieħor li baqgħu ipotensivi minkejja terapija ta' fluwidu u vażopressur ġew randomizzati 1:1 għal GIAPREZA jew plaċebo.
English: The major imbalance compared to placebo was in venous thromboembolism (6.1% vs 0%) (see section 4.8).
Maltese: L-iżbilanċ kbir meta mqabbel mal-plaċebo kien fit-tromboemboliżmu venuż (6.1 % kontra 0 %) (ara sezzjoni 4.8).
English: Of the 321 patients treated in the Phase 3 study, 195 patients were male (60.7%), 257 (80%) patients were White, 33 (10%) were Black, and 31 (10%) were Other.
Maltese: Mit-321 pazjent ikkurati fl-istudju tal-Fażi 3, 195 pazjent kienu rġiel (60.7%), 257 (80%) pazjent kienu Bojod, 33 (10%) kienu Suwed, u 31 (10%) kienu Oħrajn.
English: A total of 37 patients (23%) experienced transient hypertension with the angiotensin II 20 ng/kg/min starting dose.
Maltese: Total ta' 37 pazjenti (23%) esperjenzaw ipertensjoni temporanja b'doża tal-bidu ta' anġjotensina II 20 ng/kg/min.
English: Table 2 lists the adverse reactions recorded in clinical studies in the total safety population treated with GIAPREZA by MedDRA system organ class and frequency.
Maltese: Tabella 2 telenka r-reazzjonijiet avversi rreġistrati fl-istudji kliniċi fil-popolazzjoni totali tas-sigurtà kkurata b'GIAPREZA skont is-sistema tal-klassifika tal-organi ta' MedDRA u l-frekwenza.
English: Transient hypertension
Maltese: Ipertensjoni temporanja
English: In a cardiovascular safety pharmacology study in normotensive dogs, GIAPREZA elicited increased heart rate, systemic vascular resistance, left ventricular systolic pressure and left ventricular diastolic pressure, and PR interval prolongation.
Maltese: Fi studju tal-farmakoloġija ta' sigurtà kardjovaskulari fi klieb normossivi, GIAPREZA stimula żieda fir-rata ta' taħbit tal-qalb, reżistenza vaskulari sistemika, pressjoni sistolika ventrikulari tax-xellug u pressjoni dijastolika ventrikulari tax-xellug, u titwil tal-intervall PR.
English: GIAPREZA is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies (see section 5.1).
Maltese: GIAPREZA huwa indikat għall-kura ta' ipotensjoni refrattarja f'adulti b'xokk settiku jew xokk distributtiv ieħor li jibqgħu ipotensivi minkejja r-restituzzjoni ta' volum adegwat u l-applikazzjoni tal catecholamines u terapiji oħra disponibbli ta' vażopressur (ara sezzjoni 5.1).
English: < 1 mcg/kg/min and 21 (6%) patients were receiving high doses of vasopressors (NED ≥ 1.0 mcg/kg/min).
Maltese: fil-linja bażi ta'≥ 0.5 sa < 1 mcg/kg/min u 21 (6 %) pazjent kienu qed jirċievu dożi għoljin ta' vażopressuri (NED ≥ 1.0 mcg/kg/min).
English: Non-pharmacologic VTE prophylaxis may be considered where pharmacologic prophylaxis is contraindicated.
Maltese: Profilassi VTE mhux farmaloġika tista' tiġi kkunsidrata meta l-profilassi farmakoloġika tkun kontraindikata.