FrancophonIA/ELRC3.0 huggingface dataset:
English: Tabulated list of adverse reactions
Maltese: Tabella b'lista ta' reazzjonijiet avversi
English: More patients experienced venous and arterial thromboembolic events in the GIAPREZA arm compared to placebo arm in the Phase 3 (ATHOS-3) study (21 [12.9%] vs 8 [5.1%]).
Maltese: meta mqabbla mal-fergħa tal-plaċebo fl-istudju tal-Fażi 3 (ATHOS-3) (21 [12.9%] kontra 8 [5.1%]).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER La Jolla Pharmaceutical II B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq La Jolla Pharmaceutical II B.V.
English: More patients experienced peripheral ischaemia in the GIAPREZA arm compared to the placebo arm (7 [4.3%] vs 4 [2.5%]).
Maltese: Aktar pazjenti esperjenzaw iskemija periferali fil-fergħa ta' GIAPREZA meta mqabbla mal-fergħa tal plaċebo (7 [4.3 %] kontra 4 [2.5 %]).
English: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature and 2-8 °C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ambjentali u 2-8 °C.
English: It is metabolised by end terminal cleavage (at both the amino and carboxy termini) in a variety of tissues including erythrocytes, plasma and many of the major organs (ie, intestine, kidney, liver and lung).
Maltese: f'varjetà ta' tessuti inklużi l-eritroċiti, il-plażma u ħafna mill-organi ewlenin (jiġifieri l-musrana, il kliewi, il-fwied u l-pulmun).
English: The maximum dose after the first 3 hours will be 40 ng per kilogram each minute.
Maltese: Id-doża massima wara lewwel 3 sigħat ser tkun 40 ng għal kull kilogramma kull minuta.
English: Angiotensin II raises blood pressure by vasoconstriction; increased aldosterone release via direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein-coupled angiotensin II receptor type 1 on vascular smooth muscle cells which stimulates Ca2+/calmodulin dependent phosphorylation of myosin and causes smooth muscle contraction.
Maltese: II żżid il-pressjoni tad-demm bil-vażokostrizzjoni; żieda fir-rilaxx tal-aldosterone permezz ta' azzjoni diretta ta' anġjotensina II fuq il-ħajt tal-vażu tiġi medjata mill-irbit mar-riċettur tat-tip 1 ta' anġjotensina II akkopjat mal-proteina G fuq ċelloli tal-muskoli vaskulari lixxi li jistimula l-fosforilazzjoni tal-myosin li tiddependi fuq Ca2+/calmodulin u jikkawża kontrazzjoni tal-muskoli lixxi.
English: Discard prepared solution after 24 hours at room temperature or under refrigeration.
Maltese: Armi ssoluzzjoni ppreparata wara 24 siegħa f'temperatura ambjentali jew taħt refriġerazzjoni.
English: Baseline APACHE II > 30 17/65 patients
Maltese: APACHE II > 30 fil-linja bażi
English: No
Maltese: Tqala
English: GIAPREZA is recommended to be administered via a central venous line.
Maltese: GIAPREZA huwa rrakkomandat li jingħata minn linja venuża ċentrali.
English: The adverse reactions described in this section were identified in the pivotal clinical study (N = 163 treated with GIAPREZA).
Maltese: Ir-reazzjonijiet avversi deskritti f'din is-sezzjoni ġew identifikati fl-istudju kliniku pivotali (N = 163 ikkurati b'GIAPREZA).
English: Of these, 7 cases corresponded to deep vein thrombosis.
Maltese: Minn dawn, 7 każijiet ikkorrispondew għal trombożi profonda fil-vini.
English: For critically ill patients, the usual target mean arterial pressure is 65 - 75 mmHg.
Maltese: Għal pazjenti morda serjament, il-pressjoni arterjali medja fil-mira tas-soltu hija 65 - 75 mmHg.
English: In the ATHOS-3 trial, the median time to increase blood pressure was approximately 5 minutes.
Maltese: Fil-prova ATHOS-3, iż-żmien medjan biex tiżdied il-pressjoni tad-demm kien ta' madwar 5 minuti.
English: Other medicines and GIAPREZA
Maltese: Mediċini oħra u GIAPREZA
English: The median duration of treatment in clinical trials was 48 hours (range: 3.5 to 168 hours).
Maltese: It-tul medju tal-kura fil-provi kliniċi kien ta' 48 siegħa (medda: 3.5 sa 168 siegħa).
English: Pack size of one vial per carton.
Maltese: Daqs tal-pakkett ta' kunjett wieħed għal kull kartuna.
English: Fluid Restricted?
Maltese: Ristrett?
English: The primary endpoint was achieved by 70% of patients randomised to GIAPREZA compared to 23% of placebo subjects; p < 0.0001 (a treatment effect of 47%).
Maltese: Il-punt tat-tmiem primarju nkiseb minn 70 % tal-pazjenti randomizzati għal GIAPREZA meta mqabbla ma' 23 % tal-individwi tal-plaċebo; p < 0.0001 (effett tal-kura ta' 47 %).
English: vasodilatory shock and associated severe acute kidney injury requiring renal replacement therapy to provide: (1) data on the effect of the product on morbidity events and organ perfusion with and adequate representation of European patients, (2) reassurance that there is no detrimental effect on mortality at day 28, (3) additional safety data about ischemic and thromboembolic events associated with the use of the product and to record clinical global impression of the response to treatment.
Maltese: Ewropej, (2) riassigurazzjoni li ma hemm l-ebda effett detrimentali fuq il-mortalità f'jum 28, (3) data addizzjonali tas-sigurtà dwar avvenimenti iskemiċi u tromboemboliċi assoċjati mal-użu tal-prodott u biex tiġi rreġistrata l-impressjoni globali klinika tar rispons għall-kura.
English: Of them, 5 cases (3.1%) in the GIAPREZA arm and 3 (1.9%) cases in the placebo arm were considered serious.
Maltese: Minn dawn, 5 każijiet (3.1 %) fil-fergħa ta' GIAPREZA u 3 (1.9 %) każijiet fil-fergħa tal-plaċebo ġew ikkunsidrati bħala serji.
English: These types of symptoms occur in greater than 1 out of every 10 patients.
Maltese: Dawn it-tipi ta' sintomi jseħħu f'aktar minn 1 minn kull 10 pazjenti.
English: Posology
Maltese: Takkikardija
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq id-dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: Maintenance doses should not exceed 40 ng/kg per minute.
Maltese: Id-dożi ta' manteniment ma għandhomx jaqbżu 40 ng/kg kull minuta.
English: Dilute 1 or 2 ml of GIAPREZA in sodium chloride 9 mg/ml (0.9%) solution for injection to achieve a final concentration of 5,000 ng/ml or 10,000 ng/ml.
Maltese: Iddilwixxi 1 jew 2 ml ta' GIAPREZA f'sodium chloride 9 mg/ml (0.9 %) soluzzjoni għall injezzjoni sabiex tikseb konċentrazzjoni finali ta' 5,000 g/ml jew 10,000 ng/ml.
English: This medicine contains less than 1 mmol sodium (23 mg) per 2.5 mg/1 ml, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) għal kull 2.5 mg/ml, jiġifieri huwa essenzjalment “mingħajr sodium”.
English: For their inclusion in the study, patients had to have clinical features of high-output shock defined as a cardiac index > 2.3 L/min/m2 or the sum of central venous oxygen saturation > 70% with central venous pressure (CVP) > 8 mmHg.
Maltese: Għall-inklużjoni tagħhom fl-istudju, il-pazjenti ried ikollhom karatteristiċi kliniċi ta' xokk ta' output għoli definit bħala indiċi kardijaku > 2.3 L/min/m2 jew is-somma tas-saturazzjoni tal-ossiġenu venuż ċentrali > 70 % bi pressjoni venuża ċentrali (CVP) > 8 mmHg.
English: Use of this medicine during pregnancy should be avoided if possible.
Maltese: L-użu ta' din il-mediċina waqt it-tqala għandu jiġi evitat jekk ikun possibbli.
English: Approximately one in every four patients experienced transient hypertension with the angiotensin II 20 ng/kg per minute starting dose in clinical trials (see section 4.8), thus needing dose down-titration.
Maltese: II 20 ng/kg kull minuta fil-provi kliniċi (ara sezzjoni 4.8), u b'hekk ikunu jeħtieġu titrazzjoni 'l isfel tad-doża.
English: You will only be given this medicine if the possible benefit is greater than the possible risks.
Maltese: Inti ser tingħata din il-mediċina biss jekk ilbenefiċċju possibbli jkun akbar mir-riskji possibbli.
English: No specific studies have been conducted to investigate the distribution of GIAPREZA.
Maltese: Ma sar l-ebda studju speċifiku biex tiġi investigata d-distribuzzjoni ta' GIAPREZA.
English: Cardiac disorders
Maltese: Organi MedDRA
English: Thromboembolic eventsa Transient hypertensionb
Maltese: Ġew irrappurtati avvenimenti tromboemboliċi bl-użu tal-anġjotensina
English: Down-titrate by gradual decrements of up to 15 ng/kg per minute, as needed, based on blood pressure, in order to avoid hypotension due to abrupt withdrawal (see section 4.4).
Maltese: Ittitra d-doża 'l isfel permezz ta' tnaqqis gradwali sa 15 ng/kg kull minuta, kif meħtieġ, abbażi tal-pressjoni tad-demm, sabiex tiġi evitata ipotensjoni minħabba twaqqif f'daqqa (ara sezzjoni 4.4).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu
English: Of the 321 patients, 227 (71%) were receiving a baseline norepinephrine equivalent dose (NED) < 0.5 mcg/kg/min, 73 patients (23%) were receiving baseline NED ≥ 0.5 to
Maltese: norepinephrine (NED) fil-linja bażi ta' < 0.5 mcg/kg/min, 73 pazjent (23 %) kienu qed jirċievu NED
English: Unopened vial
Maltese: Komuni ħafna
English: When you are first given GIAPREZA, it is expected that your blood pressure will increase.
Maltese: Meta tingħata l-ewwel GIAPREZA, huwa mistenni li l-pressjoni tad-demm tiegħek tiżdied.
English: GIAPREZA is supplied in a carton as a 1 x 1 ml or 1 x 2 ml single use vial.
Maltese: GIAPREZA jiġi f'kartuna ta' 1 x 1 ml jew 1 x 2 ml kunjett għal użu ta' darba.
English: One or two millilitres of GIAPREZA must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection to achieve a final concentration of 5,000 ng/mL or 10,000 ng/mL (see Table 1).
Maltese: Millilitru wieħed jew tnejn ta' GIAPREZA għandu jiġi dilwit f'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni biex tinkiseb konċentrazzjoni finali ta' 5,000 ng/mL jew 10,000 ng/mL (ara
English: Patients also had to have catecholamine refractory hypotension (CRH) defined as requiring a total sum vasopressor dose of > 0.2 mcg/kg/min for 6 to 48 hours, to maintain a mean arterial pressure (MAP) between 55-70 mmHg and receiving at least 25 mL/kg of crystalloid or colloid equivalent over the previous 24-hour period and be adequately volume resuscitated in the opinion of the treating investigator.
Maltese: 70 mmHg u li jirċievu tal-inqas 25 mL/kg ta' crystalloid jew colloid ekwivalenti matul il-perjodu preċedenti ta' 24 siegħa u li jkollhom il-volum risuxxitat b'mod adegwat fl-opinjoni tal-investigatur li qed jikkura.
English: GIAPREZA contains the active substance angiotensin II, a compound normally produced by the body.
Maltese: X'inhu GIAPREZA u għal xiex jintuża GIAPREZA fih is-sustanza attiva anġjotensina II, kompost normalment prodott mill-ġisem.
English: At the time of study drug administration, 97% of subjects were receiving norepinephrine, 67% vasopressin, 15% phenylephrine, 13% epinephrine, and 2% dopamine.
Maltese: 67% vasopressin, 15% phenylephrine, 13% epinephrine, u 2 % dopamine. 83 % tal-individwi kienu rċevew żewġ vażopressuri jew aktar u 47 % tliet vażoppressuri jew aktar qabel l-għoti tal-mediċina tal-istudju.
English: How to store GIAPREZA
Maltese: X'fih GIAPREZA
English: The treatment effect was consistent in high risk subsets of patients with low baseline MAP or high APACHE II score, which were stratification variables (Table 3).
Maltese: L-effett tal-kura kien konsistenti f'subsettijiet ta' riskju għoli ta' pazjenti b'MAP fil-linja bażi baxxa jew punteġġ għoli ta' APACHE II, li kienu varjabbli tal-istratifikazzjoni (Tabella 3).
English: There is limited information about the effects of GIAPREZA during pregnancy.
Maltese: Hemm informazzjoni limitata dwar l-effetti ta' GIAPREZA waqt it-tqala.
English: Transient hypertension may be promptly mitigated by dose down-titration (see section 4.2).
Maltese: Ipertensjoni temporanja tista' tiġi mtaffija minnufih b'titrazzjoni 'l isfel tad-doża (ara sezzjoni 4.2).
English: In a 48-hour continuous intravenous administration of angiotensin II in neonatal lambs, the nominal dose rates of 4, 12 and 40 ng/kg/min were well tolerated.
Maltese: II fi ħrief li jkunu għadhom kif twieldu, ir-rati ta' doża nominali ta' 4, 12 u 40 ng/kg/min kienu ttollerati sew.
English: Do not exceed 80 ng/kg per minute during the first 3 hours of treatment.
Maltese: Taqbiżx 80 ng/kg kull minuta matul l-ewwel 3 sigħat ta' kura.
English: The major imbalance corresponded to venous thromboembolism (10 [6.1%] vs 0 [0%] respectively).
Maltese: L-iżbilanċ kbir kien jikkorrispondi għal tromboemboliżmu venuż (10 [6.1 %] kontra 0
English: Concurrent venous thromboembolism prophylaxis (VTE) should be used unless contraindicated during treatment with GIAPREZA.
Maltese: Għandha tintuża profilassi ta' tromboemboliżmu venuż (VTE) konkomitanti sakemm ma tiġix kontraindikata waqt il-kura b'GIAPREZA.
English: Use during pregnancy should be avoided if possible and the potential benefit to the patient weighed against any possible risk to the foetus.
Maltese: Jekk ikun possibbli għandu jiġi evitat l-użu waqt ittqala u l-benefiċċju potenzjali għall-pazjenta għandu jiġi kkonsidrat kontra kull riskju possibbli għall fetu.
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux il pakketti tad-daqsijiet kollha jkunu fis-suq.
English: NAME OF THE MEDICINAL PRODUCT GIAPREZA 2.5 mg/ml concentrate for solution for infusion angiotensin II
Maltese: TAL-PRODOTT MEDIĊINALI GIAPREZA 2.5 mg/ml konċentrat għal soluzzjoni għall-infużjoni anġjotensina II
English: Due to the short half-life of GIAPREZA (less than one minute), an abrupt withdrawal of angiotensin may lead to rebound hypotension (see section 4.4).
Maltese: Minħabba l-half life qasira ta' GIAPREZA (inqas minn minuta), twaqqif f'daqqa tal-anġjotensina jista' jwassal għal ipotensjoni rikorrenti (ara sezzjoni 4.4).
English: Mannitol
Maltese: Anzjani
English: Yes
Maltese: ISEM
English: Concentrate for solution for infusion 1 vial
Maltese: Tabella 1: Preparazzjoni tas-soluzzjoni dilwita Fluwidu
English: The recommended starting rate of GIAPREZA is 20 nanograms (ng) per kilogram of your body weight per minute.
Maltese: 20 nanogramma (ng) għal kull kilogramma tal-piż tal-ġisem tiegħek kull minuta.
English: No specific studies have been conducted to investigate the metabolism and excretion of GIAPREZA.
Maltese: Ma sar l-ebda studju speċifiku biex jiġi investigat il-metaboliżmu u l-eskrezzjoni ta' GIAPREZA.
English: Approximately one in every four patients experienced transient hypertension with the angiotensin II 20 ng/kg/min starting dose in clinical trials (see section 4.8), thus needing dose downtitration.
Maltese: II 20 ng/kg/min fil-provi kliniċi (ara sezzjoni 4.8), u b'hekk ikunu jeħtieġu titrazzjoni 'l isfel tad-doża.
English: Baseline MAP < 65 mmHg 10/50 patients
Maltese: < 65 mmHg
English: In order to minimise the risk of adverse events derived from prolonged vasoconstriction, treatment with GIAPREZA should be withdrawn once underlying shock is sufficiently improved (see section 4.4 and 4.8).
Maltese: Sabiex jitnaqqsu l-avvenimenti avversi derivati mill-vażokostrizzjoni mtawla, il-kura għandha tiġi rtirata hekk kif ix-xokk sottostanti jittejjeb b'mod suffiċjenti (ara sezzjonijiet 4.2 u 4.4).
English: What GIAPREZA looks like and contents of the pack GIAPREZA is presented as a concentrate for solution for infusion (sterile concentrate).
Maltese: GIAPREZA huwa ppreżentat bħala konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili).
English: One vial of 1 ml concentrate for solution for infusion contains 2.5 mg of angiotensin II One vial of 2 ml concentrate for solution for infusion contains 5 mg of angiotensin II - The other ingredients are mannitol and water for injections adjusted with sodium hydroxide and/or hydrochloric acid (see section 2 under ‘Sodium').
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodium (23 mg) għal kull 2.5 mg/1 ml, jiġifieri hija essenzjalment “mingħajr sodium”.
English: - Keep this leaflet.
Maltese: azzjoni ta' GIAPREZA.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Maltese: Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata.
English: A number of medicines may affect the way GIAPREZA works, such as: - Angiotensin converting enzyme (ACE) inhibitors (medicines used to lower blood pressure, with active substances whose name usually end in -pril).
Maltese: Għadd ta' mediċini jistgħu jaffettwaw il-mod kif jaħdem GIAPREZA, bħal: - Inibituri ta' enzima ta' konverżjoni tal-anġjotensina (ACE) (mediċini użati biex ibaxxu l-pressjoni tad-demm, b'sustanzi attivi li l-isem tagħhom normalment jispiċċa b'-pril).
English: In order to minimise the risk of side effects to this medicine, GIAPREZA will be withdrawn as soon as your condition improves.
Maltese: Sabiex jitnaqqas ir-riskju ta' effetti sekondarji għal din il-mediċina, GIAPREZA ser jitwaqqaf hekk kif il-kondizzjoni tiegħek titjieb.
English: There are limited efficacy and safety data of GIAPREZA in patients > 75 years.
Maltese: Anzjani Hemm data limitata dwar l-effikaċja u s-sigurtà ta' GIAPREZA f'pazjenti ta' > 75 sena.
English: Plasma levels of angiotensin II were evaluated at baseline and hour 3 of infusion in the phase 3 pivotal study.
Maltese: II ġew evalwati fil-linja bażi u f'siegħa 3 tal-infużjoni fl-istudju pivotali tal-fażi 3.
English: Patients with active bleeding, mesenteric ischaemia, liver failure and MELD score of ≥ 30, CV SOFA score ≤ 3 and patients with extensive burns were also excluded.
Maltese: Pazjenti bi fsada attiva, bi skemija mesenterika, insuffiċjenza tal-fwied u punteġġ ta' MELD ta' ≥ 30, punteġġ ta' SOFA ta' CV ta' ≤ 3 u pazjenti bi ħruq estensiv ukoll ġew esklużi.
English: GIAPREZA should only be administered by continuous intravenous infusion under close monitoring of haemodynamics and end-organ perfusion.
Maltese: GIAPREZA għandu jingħata biss permezz ta' infużjoni ġol-vina kontinwa taħt monitoraġġ mill-qrib tal-emodinamika u perfużjoni tal-organu finali.
English: NAME OF THE MEDICINAL PRODUCT GIAPREZA 2.5 mg/ml concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI GIAPREZA 2.5 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: No in vitro metabolism studies have been performed with GIAPREZA.
Maltese: Ma twettaq l-ebda studju tal-metaboliżmu in vitro b'GIAPREZA.
English: GIAPREZA 2.5 mg/ml concentrate for solution for infusion angiotensin II
Maltese: Informazzjoni għall-pazjent GIAPREZA 2.5 mg/ml konċentrat għal soluzzjoni għall-infużjoni anġjotensina II
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 2.5 mg of angiotensin II (as acetate)
Maltese: Kull ml fih 2.5 mg ta' anġjotensina II (bħala aċetat) LISTA
English: Patients with cardiogenic shock were excluded (see section 4.4).
Maltese: Il-pazjenti b'xokk kardjoġeniku ġew esklużi (ara sezzjoni 4.4).
English: Two (1.2%) patients in the GIAPREZA arm experienced a fatal thromboembolic event compared with no patients in the placebo arm. Concurrent venous thromboembolism prophylaxis should be used unless contraindicated during treatment with GIAPREZA (see section 4.4).
Maltese: Għandha tintuża profilassi ta' tromboemboliżmu venuż konkomitanti sakemm ma tkunx kontraindikata waqt il-kura b'GIAPREZA (ara sezzjoni 4.4).
English: Placebo response rate
Maltese: Rata ta' rispons tal plaċebo
English: Stopping GIAPREZA treatment
Maltese: Kif jintuża GIAPREZA
English: 5 mg/2 mL 2
Maltese: 2.5 mg/mL 1 5 mg/2 mL 2
English: The plasma half-life of angiotensin II administered intravenously is less than one minute.
Maltese: Millat mikrobijoloġiku, il-prodott għandu jintuża immedjatament.
English: Post-authorisation efficacy study (PAES): In order to further investigate the efficacy and safety of Giapreza in the treatment of refractory hypotension in adults with septic or other distributive shock, the MAH should conduct and submit the results of a randomized, double-blind placebo-controlled multicentre study in adult patients with
Maltese: Sabiex ikomplu jiġu investigati l-effikaċja u s-sigurtà ta' Giapreza fil-kura ta' ipotensjoni refrattorja fl-adulti b'xokk settiku jew distributtiv ieħor, l-MAH għandu jwettaq u jissottometti r-riżultati ta' studju randomizzat, double-blind, ikkontrollat bi plaċebo, multiċentriku f'pazjenti adulti b'xokk vażodilatorju u ħsara tal-kliewi akuta severa assoċjata li tirrikjedi terapija ta'
English: Thromboembolic events have been reported with the use of angiotensin II in clinical trials.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: It is not known whether GIAPREZA can affect fertility.
Maltese: Għadu mhuwiex magħruf jekk GIAPREZA jistax jaffettwa l-fertilità.
English: Concomitant administration of GIAPREZA and other vasopressors may have an additive effect on mean arterial pressure (MAP).
Maltese: L-għoti konkomitanti ta' GIAPREZA u vażopressuri oħrajn jista' jkollu effett addittiv fuq il-pressjoni arterjali medja (MAP).
English: 2 ml solution in a Type I glass vial with an aluminium over-seal, stopper (elastomeric), and plastic cap.
Maltese: Soluzzjoni ta' 2 ml f'kunjett tal-ħġieġ tat-Tip I b'tapp tal-aluminju b'għeluq ieħor (elastomeriku), u għatu tal-plastik.
English: Withdraw amount (mL)
Maltese: (mL)
English: It is important to administer GIAPREZA at the lowest compatible dose to achieve or maintain adequate arterial blood pressure and tissue perfusion (see section 4.4).
Maltese: Huwa importanti li GIAPREZA jingħata bid-doża kompatibbli l-aktar baxxa sabiex tinkiseb jew tinżamm pressjoni arterjali tad-demm adegwata u perfużjoni tat-tessuti (ara sezzjoni 4.4).
English: Vascular disorders
Maltese: vażopressuri oħra.
English: Store in a refrigerator (2 - 8 °C).
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2 - 8 °C).
English: Primary efficacy endpoints: MAP response at hour 3 (mITT population and subgroups)
Maltese: (popolazzjoni mITT u sottogruppi)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: UŻU Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: - Angiotensin II receptor blockers (medicines used to lower blood pressure, with active substances whose names usually end in -sartan) may lessen the effect of GIAPREZA.
Maltese: - Imblokkaturi tar-riċetturi tal-anġjotensina II (mediċini li jintużaw biex ibaxxu l-pressjoni taddemm, b'sustanzi attivi li l-ismijiet tagħhom normalment jispiċċaw b'-sartan) jistgħu jnaqqsu l effett ta' GIAPREZA.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The use of GIAPREZA is not recommended in other types of shock (e.g.: cardiogenic shock, etc) as patients with non-distributive shocks were excluded from clinical trials (see section 5.1).
Maltese: L-użu ta' GIAPREZA mhuwiex rakkomandat f'tipi oħra ta' xokk (eż. xokk kardjoġeniku, eċċ) peress li pazjenti b'xokkijiet mhux distributtivi ġew esklużi mill-provi kliniċi (ara sezzjoni 5.1).
English: GIAPREZA will be given to you in a hospital by a doctor or a nurse.
Maltese: GIAPREZA ser jingħatalek fi sptar minn tabib jew infermier.
English: 1 ml solution in a Type I glass vial with an aluminium over-seal, stopper (elastomeric), and plastic cap.
Maltese: Soluzzjoni ta' 1 ml f'kunjett tal-ħġieġ tat-Tip I b'tapp tal-aluminju b'għeluq ieħor (elastomeriku), u għatu tal-plastik.
English: IMMUNOSUPPRESSANTS Ciclosporin
Maltese: IMMUNOSUPPRESSANTI Ciclosporin
English: 24 weeks n/N % CIa n/N % CIa
Maltese: Ġimgħa n/N % CIa n/N % CIa
English: Norgestimate metabolites:
Maltese: Metaboliti ta' norgestimate:
English: HMG CoA REDUCTASE INHIBITOR Rosuvastatin
Maltese: INIBITUR HMG CoA REDUCTASE Rosuvastatin