FrancophonIA/ELRC3.0 huggingface dataset:
English: To ensure optimal antibody levels against all vaccine serogroups, the primary vaccination schedule with Menveo should be completed one month prior to risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y. Bactericidal antibodies (hSBA≥1:8) were observed in at least 64% of subjects at 1 week post vaccination (see section 5.1 for immunogenicity data per individual serogroups).
Maltese: Biex tiżgura livelli ottimali ta' antikorpi kontra s-serogruppi kollha tat-tilqima, l-iskeda ta' tilqim primarju b'Menveo għandha titlesta xahar qabel ir-riskju ta' esponiment għal Neisseria meningitidis gruppi A, C, W-135 u Y.
English: Musculoskeletal and connective tissue disorders: Common: myalgia, arthralgia General disorders and administration site conditions:
Maltese: Komuni: raxx Disturbi muskolu-skeletriċi u tat-tessuti konnettivi:
English: Table 2: Immunogenicity of one dose of Menveo or ACWY-PS in subjects 2 through 10 years of age, measured at one month and twelve months post-vaccination
Maltese: Tabella 2: Immunoġeniċità ta' doża waħda ta' Menveo jew ta' ACWY-PS f'individwi minn 2 sa 10 snin, imkejla xahar u tnax-il xahar wara l-vaċċinazzjoni
English: Anxiety‐related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see section 4.8 Undesirable effects).
Maltese: Reazzjonijiet relatati mal-ansjetà, li jinkludu reazzjonijiet vasovagali (sinkope), iperventilazzjoni jew reazzjonijiet relatati mal-istress jistgħu jseħħu b'rabta mat-tilqima bħala rispons psikoġeniku għall-injezzjoni bil-labra (ara sezzjoni 4.8 Effetti mhux mixtieqa).
English: Serogr oup
Maltese: Tilqima booster
English: MenA Conjugate
Maltese: Konjugat ta' MenA
English: Very common (may affect more than 1 in 10 people): sleepiness, headache, irritability, generally feeling unwell, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm)
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10): ngħas, uġigħ ta' ras, irritabilità, tħossok ma tiflaħx b'mod ġenerali, uġigħ fis-sit tal-injezzjoni, ħmura fis-sit tal-injezzjoni (≤50 mm),
English: Both groups showed a robust response to the booster dose of Menveo at one month after vaccination (100% of subjects had hSBA ≥ 1:8 across serogroups) and this response largely persisted through 2 years after the booster dose for serogroups C, W-135 and Y (with 87% to 100% of subjects with hSBA ≥ 1:8 across serogroups).
Maltese: Iż-żewġ gruppi urew rispons qawwi għad-doża booster ta' Menveo xahar wara t-tilqima (100% tal-individwi kellhom hSBA ta' ≥ 1:8 fis-serogruppi kollha) u dan ir-rispons ippersista fil-biċċa l-kbira tiegħu sa sentejn wara d-doża booster għal serogruppi C, W-135 u Y (bi 87% sa 100% tal-individwi b'hSBA
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Maltese: Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata.
English: Whereas
Maltese: Tel.
English: Background information
Maltese: Informazzjoni lill-pazjenti
English: The relative risk reduction of proximal femur and hip area fractures with strontium ranelate over 3 years (FAS population from TROPOS) was not statistically significant compared with placebo: 15% (RR=0.85, 95% CI [0.61; 1.19], p=0.333) and 21% (RR=0.79, 95% CI [0.59; 1.06], p=0.112), respectively.
Maltese: Ir-riżultati wrew żieda fir-riskju ta' infart mijokardijaku bi Protelos / Osseor meta mqabbla mal-plaċebo (1.7% kontra 1.1%), b'riskju relattiv ta' 1.6 (95% CI, 1.07-2.38), u żieda fir-riskju ta' episodji trombotiċi fil-vini u avvenimenti emboliċi - 1.9% kontra 1.3% b'riskju relattiv ta' 1.5 (95% CI,
English: • The Committee considered Protelos and Osseor (strontium ranelate) in the procedure under Article 20 of Regulation (EC) No 726/2004, initiated by the European Commission.
Maltese: Ir-reviżjoni ta' Protelos/Osseor inbdiet f'Mejju 2013 fuq talba tal-Kummissjoni Ewropea skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004.
English: Overall summary of the scientific evaluation of Protelos/Osseor by the PRAC
Maltese: Protelos/Osseor jibqa' disponibbli iżda b'aktar restrizzjonijiet
English: Benefits of strontium ranelate in the treatment of osteoporosis
Maltese: Aktar dwar il-mediċina
English: The CHMP agreed with the conclusions of the PRAC that the use of strontium ranelate in a broad osteoporosis population (postmenopausal population) is associated with a number of serious risks; namely serious cardiac disorders (including myocardial infarction), thromboembolic events (including VTE), serious skin reactions (including DRESS syndrome, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis), disturbances in consciousness, seizures, hepatitis and blood cytopenic disorders.
Maltese: Iż-żewġ kumitati ħadmu b'kollaborazzjoni mill-qrib u r-rakkomandazzjoni tal-PRAC kienet strumentali għalina biex nevalwaw b'mod sħiħ il-profil tal-benefiċċju-riskju tal-mediċina ‘, qal Tomas Salmonson, president tasCHMP. ‘Madankollu, is-CHMP ikkunsidra li, għal pazjenti li ma għandhom l-ebda kura alternattiva, skrinjar u monitoraġġ regolari biex jeskludu mard kardjovaskulari se jnaqqas biżżejjed ir-riskju identifikat mill-PRAC sabiex dawn il-pazjenti jista' jibqa' jkollhom aċċess għall-mediċina.'
English: Strontium ranelate dissociates at the gastrointestinal level.
Maltese: Aktar informazzjoni dwar ir-rakkomandazzjoni PRAC u l-isfond għal din l-analiżi jinstabu fuq il-websajt tal-Aġenzija.
English: In order to assess the impact of the restrictions introduced in the product information, namely the restriction to patients with severe osteoporosis and patients without the contraindications (current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism; temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest; established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, or uncontrolled hypertension), post-hoc subgroup analyses of the existing clinical trial data were performed.
Maltese: Dejta disponibbli ma wrietx evidenza ta' riskju kardjovaskulari miżjud f'pazjenti mingħajr storja filpreżent jew fil-passat ta' mard tal-qalb iskemiku, mard arterjali periferali jew mard ċerebrovaskulari stabbilit, jew dawk li ma jbatux minn pressjoni għolja mhux ikkontrollata.
English: The CHMP, having considered the PRAC recommendation dated January 2014 and the totality of the information provided by the MAH, is of the opinion that the benefit-risk balance of strontium ranelate remains positive in the restricted population, taking into account the agreed risk minimisation measures, including changes to the product information and additional pharmacovigilance activities.
Maltese: Biex wasal għall-konklużjonijiet tiegħu, is-CHMP innota li d-dejta ta' studju wriet effett benefiċjali filprevenzjoni ta' ksur, inkluż f'pazjenti b'riskju għoli ta' ksur.
English: The postmenopausal osteoporotic (PMO) population for strontium ranelate comprises data from 7 randomised studies: 2 phase II studies CL2-004 (Meunier, 2002; NP07869) and CL2-005 (Reginster 2002; NP08511) and 5 phase III studies CL3-009 (Meunier, 2004; NP08338/NP22819), CL3-010 (Reginster 2005; NP08340/NP22824), CL3-013 (Hwang 2008; NP22514), CL3-015 (Liu 2009; NP25026), CL3-017 (NP24357).
Maltese: • Protelos/Osseor għandu jintuża biss biex jikkura l-osteoporożi severa fin-nisa wara l-menopawsa u rġiel b'riskju għoli ta' ksur, li għalihom kura bi prodotti mediċinali oħra approvati għall-kura ta' osteoporożi mhix possibbli minħabba, pereżempju, kontraindikazzjonijiet jew intolleranza;
English: Strontium ranelate is associated with a number of serious adverse events including serious cardiac disorders, thromboembolic events, serious skin reactions, disturbances in consciousness, seizures, hepatitis and blood cytopenic disorders.
Maltese: Kif irrakkomandat firreviżjoni preċedenti, il-pazjenti li għandhom storja ta' ċerti problemi tal-qalb jew problemi ċirkolatorji, bħal puplesija u attakk tal-qalb, ma għandhomx jużaw il-mediċina.
English: • The Committee also considered that there are serious concerns on whether the contraindications and warnings implemented to mitigate cardiac and thromboembolic risks could be achievable in clinical practice, considering that Protelos and Osseor are intended for long-term treatment of a population of elderly patients whose cardiovascular status may deteriorate over time.
Maltese: • Protelos/Osseor se jiġi preskritt biss għall-prevenzjoni ta' ksur f'nisa wara l-menopawsa u rġiel b'osteoporożi severa li għandhom riskju għoli ta' ksur u li ma jistgħux jiġu trattati b'mediċini oħrajn approvati għall-osteoporożi.
English: Data submitted as part of the routine benefit-risk assessment within a periodic safety update report (PSUR), covering the period from 22 September 2011 to 21 September 2012, was assessed by the PRAC and raised concerns regarding cardiovascular safety beyond the already recognised risk for venous thromboembolism.
Maltese: Ir-rakkomandazzjonijiet attwali jżidu mar-rakkomandazzjonijiet tal-EMA li saru f'April 2013 biex ma jintużax Protelos/Osseor f'pazjenti bi problemi taċ-ċirkolazzjoni magħrufa.
English: Further information on Bortezomib Fresenius Kabi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
Maltese: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
English: Bortezomib Fresenius Kabi is a ‘generic medicine'.
Maltese: Bortezomib Fresenius Kabi huwa “mediċina ġenerika”.
English: The active substance in Bortezomib Fresenius Kabi, bortezomib, is a proteasome inhibitor.
Maltese: Is-sustanza attiva f'Bortezomib Fresenius Kabi, il-borteżomib, hija inibitur ta' proteasome.
English: For mantle cell lymphoma, Bortezomib Fresenius Kabi is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Maltese: Kabi jintuża flimkien ma' rituximab, cyclophosphamide, doxorubicin u prednisone.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Velcade, and do not need to be repeated for Bortezomib Fresenius Kabi.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu awtorizzat tal-mediċina ta' referenza, Velcade, u m'hemmx għalfejn jiġu ripetuti għal Bortezomib Fresenius Kabi.
English: When given into a vein, the solution is given as a three- to five-second injection through a catheter (a thin sterile tube).
Maltese: Meta tingħata ġol-vina, issoluzzjoni tingħata b'injezzjoni li ddum tingħata bejn tlieta u ħames sekondi, minn ġo kateter (tubu sterili rqiq).
English: For more information on generic medicines, see the question-andanswer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument bil-mistoqsijiet u t-tweġibiet hawnhekk.
English: Bortezomib Fresenius Kabi is a medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Maltese: Bortezomib Fresenius Kabi huwa mediċina li tintuża għall-kura ta' mijeloma multipla, kanċer fid-demm, fil-gruppi ta' pazjenti li ġejjin:
English: How is Bortezomib Fresenius Kabi used?
Maltese: Bortezomib Fresenius Kabi?
English: Bortezomib Fresenius Kabi (bortezomib)
Maltese: Għal-linfoma taċ-ċelloli mantle, Bortezomib Fresenius
English: Bortezomib Fresenius Kabi is available in vials (3.5 mg) as a powder to be made up into a solution for injection.
Maltese: Bortezomib Fresenius Kabi jiġi bħala trab f'kunjetti (3.5 mg) biex jiġi magħmul f'soluzzjoni għallinjezzjoni.
English: In these patients, Bortezomib Fresenius Kabi is used in combination with melphalan and prednisone;
Maltese: F'dawn il-pazjenti, Bortezomib Fresenius Kabi jintuża flimkien ma' melphalan u prednisone;
English: Other information about Bortezomib Fresenius Kabi
Maltese: L-effetti sekondarji rrappurtati b'Bortezomib Fresenius
English: This means that Bortezomib Fresenius Kabi contains the same active substance, bortezomib, and works in the same way as a ‘reference medicine' already authorised in the EU called Velcade.
Maltese: Dan ifisser li Bortezomib Fresenius Kabi fih listess sustanza attiva, il-borteżomib, u jaħdem bl-istess mod bħal “mediċina ta' referenza” diġà awtorizzata fl-UE li jisimha Velcade.
English: There was no need for ‘bioequivalence' studies to investigate whether Bortezomib Fresenius Kabi is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' “bijoekwivalenza” biex jiġi investigat jekk Bortezomib Fresenius Kabi jiġix assorbit b'mod simili għall-mediċina ta' referenza biex jipproduċi l-istess livell tassustanza attiva fid-demm.
English: As for all medicines, data on the use of Bortezomib Fresenius Kabi are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Bortezomib Fresenius Kabi hija ssorveljata kontinwament.
English: • adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, a blood stem-cell transplant.
Maltese: • adulti li l-marda tagħhom qiegħda tmur għall-agħar wara tal-inqas kura waħda u li diġà sarilhom, jew li ma jistax isirilhom, trapjant taċ-ċelloli staminali tad-demm.
English: It blocks the proteasome, which is a system within the cells that breaks down proteins when they are no longer needed.
Maltese: Din timblokka l-proteasome, li hija sistema fiċ-ċelloli li tkisser il-proteini meta dawn ma jkunx għad hemm bżonnhom.
English: How has Bortezomib Fresenius Kabi been studied?
Maltese: Kif ġie studjat Bortezomib Fresenius Kabi?
English: Tachycardia2, bradycardia3,
Maltese: Takikardija2, bradikardija3
English: Flolan is not a conventional anticoagulant.
Maltese: Flolan mhuwiex antikoagulant konvenzjonali.
English: Local infection*
Maltese: Infezzjoni lokali*
English: Anxiety, nervousness
Maltese: Ansjetà, nervożiżmu
English: The active substance is epoprostenol sodium.
Maltese: Is-sustanza attiva hi epoprostenol sodium.
English: 10 mL concentrated solution + 40 mL sodium chloride 0.9% w/v solution.
Maltese: 10 mL ta' soluzzjoni kkonċentrata + 40 mL ta' soluzzjoni ta' sodium chloride 0.9% w/v.
English: 25°C.
Maltese: -40.7 metri).
English: Elevated serum glucose levels have been reported (see section 4.8).
Maltese: Ġew irrappurtati livelli għoljin ta' glucose fis-serum (ara sezzjoni 4.8).
English: Infusion rate (mL/h) = Infusion rate (mL/min) x 60
Maltese: Rata tal-infużjoni (mL/siegħa) = Rata tal-infużjoni (mL/min) x 60
English: Flolan contains Sodium.
Maltese: Flolan fih Sodium.
English: • pale skin
Maltese: • ġilda pallida
English: Store the solvent below 25°C.
Maltese: Aħżen is-solvent f'temperatura taħt 25°C.
English: Improvements from baseline in cardiac index (0.33 vs. -0.12 L/min/m2), stroke volume (6.01 vs. -1.32 mL/beat), arterial oxygen saturation (1.62 vs. -0.85%), mean pulmonary artery pressure (-5.39 vs. 1.45 mm Hg), mean right atrial pressure (-2.26 vs. 0.59 mm Hg), total pulmonary resistance (-4.52 vs. 1.41 Wood U), pulmonary vascular resistance (-3.60 vs. 1.27 Wood U), and systemic vascular resistance (-4.31 vs. 0.18 Wood U) were statistically different between patients who received epoprostenol chronically and those who did not.
Maltese: 12 L/min/m2), fil-volum ta' demm mitfugħ il-barra millventrikulu ma' kull taħbita (6.01 vs. -1.32 mL/taħbita), fis-saturazzjoni tal-ossignu fl-arterji (1.62 vs.0.85%), fil-medja tal-pressjoni tal-arterji tal-pulmun (-5.39 vs. 1.45 mm Hg), fil-medja tal-pressjoni tal-atriju tan-naħa tal-lemin (-2.26 vs. 0.59 mm Hg), fir-reżistenza totali tal-pulmun (-4.52 vs. 1.41 U Wood), firreżistenza vaskulari tal-pulmun (-3.60 vs. 1.27 U Wood), u fir-reżistenza sistemika vaskulari (-4.31 vs. 0.18 U Wood) kienu differenti b'mod statistiku bejn pazjenti li rċivew epoprostenol b'mod kroniku u dawk li ma ħaduhx.
English: Dosage (nanograms/ kg/min)
Maltese: Doża (nanogrammi /kg/min)
English: Mean systemic arterial pressure was not significantly different between the two groups (-4.33 vs. -3.05 mm Hg).
Maltese: Il-medja tal-pressjoni sistemika fl-arterji ma kinetx differenti b'mod sinifikanti bejn iż-żewġ gruppi (-4.33 vs. -3.05 mm Hg).
English: Pharmacotherapeutic group: Antithrombotic Agents; Platelet aggregation inhibitors excl. heparin, ATC code: B01AC09
Maltese: Sustanzi Antitrombotiċi; Impedituri tal-aggregazzjoni tal-plejtlits minbarra heparin, Kodiċi ATC:
English: Epoprostenol potentiates the anticoagulant activity of heparin by approximately 50%, possibly reducing the release of heparin neutralising factor.
Maltese: Epoprostenol iqawwi l-attività antikoagulanti ta' heparin b'madwar 50%, u x'aktarx inaqqas ir-reħi tal-fattur li jinnewtralizza l-heparin.
English: Very rare side effects These may affect up to 1 in 10,000 people:
Maltese: Effetti sekondarji rari ħafna Dawn jistgħu jaffettwaw sa persuna 1 minn kull 10,000:
English: Resultant concentration = 2,000 nanograms/mL Flolan:
Maltese: Il-konċentrazzjoni li tinkiseb = 2,000 nanogrammi/mL Flolan:
English: 4.6 Fertility, pregnancy,and lactation
Maltese: .6 Fertilità, tqala u treddigħ
English: However, the reverse was observed for postdialysis days with epoprostenol (N=1/5) compared to heparin (N=8/16).
Maltese: Madankollu, ġie osservat il-kontra għall-jiem ta' wara d-dijalisi b'epoprostenol (N=1/5) meta mqabbel ma' heparin (N=8/16).
English: dosage (nanogram/kg/min) x bodyweight (kg)
Maltese: doża (nanogramma/kg/min) x piż tal-ġisem (kg)
English: For a full list of excipents, see section 6.1
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: At normal physiological pH and temperature, epoprostenol breaks down spontaneously to 6-oxoprostaglandin F1 alpha, although there is some enzymatic degradation to other products.
Maltese: F'pH fiżjoloġika u temperatura normali, epoprostenol jitkisser b'mod spontanju u jsir 6-oxo-prostaglandin F1 alpha, għalkemm hemm xi degratazzjoni bl-enzimi li jibdluh fi prodotti oħra.
English: a. Using concentrated solution, i.e. 10,000 nanograms/mL Flolan:
Maltese: Użu tas-soluzzjoni kkonċentrata, i.e. 10,000 nanogramma/mL Flolan:
English: Frequencies are defined as follows: very common ≥1/10 (≥10%); common ≥1/100 and <1/10 (≥1% and <10%); uncommon ≥1/1000 and <1/100 (≥0.1% and <1%); rare ≥1/10,000 and <1/1000 ( ≥0.01% and <0.1%); very rare <1/10,000 (< 0.01%) and not known (cannot be estimated from the available data).
Maltese: 1% u <1%); rari ≥1/10,000 u <1/1000 ( ≥0.
English: Solvent for parenteral use:
Maltese: Solvent għal użu parenterali:
English: The combined baseline 6-minute walk test median values for the conventional therapy group and epoprostenol plus conventional therapy group was 266 meters and 301 meters, respectively.
Maltese: Il-valuri medjani kkombinati fil-linja bażi tat-test ta'6 minuti mixi għallgrupp ta' terapija konvenzjonali u l-grupp ta' epoprostenol flimkien ma' terapija konvenzjonali kienu ta' 266 metru u 301 metru, rispettivament.
English: Reconstitution and dilution should be carried out immediately prior to use (see section 4.2, section 6.3 and Section 6.6).
Maltese: Ir-rikostituzzjoni u d-dilwizzjoni għandhom isiru immedjatament qabel l-użu (ara sezzjoni 4.2, sezzjoni 6.3 u sezzjoni 6.6).
English: Infections and Infestations Common
Maltese: Infezzjonijiet u infestazzjonijiet Komuni
English: Nineteen patients received 51 heparin dialyses and 19 received 44 epoprostenol dialyses in major controlled studies.
Maltese: Dsatax-il pazjent irċivew 51 dijalisi b'heparin u 19 irċivew 44 dijalisi b'epoprostenol fi studji prinċipali kkontrollati.
English: However, more patients in both treatment groups (28/51 [55%] with epoprostenol and 35/48 [73%] with conventional therapy alone) showed no change in functional class, and 2/51 (4%) with epoprostenol and 13/48 (27%) with conventional therapy alone worsened.
Maltese: Madankollu, kien hemm aktar pazjenti fiż-żewġ gruppi ta' kura (28/51 [55%] b'epoprostenol u 35/48 [73%] b'terapija konvenzjonali waħedha) li ma wrew l-ebda bidla fil-klassi ta' funzjoni, u 2/51 (4%) b'epoprostenol u13/48 (27%) b'terapija konvenzjonali waħedha marru għall-agħar.
English: Epoprostenol Sodium, the monosodium salt of epoprostenol, a naturally occurring prostaglandin produced by the intima of blood vessels.
Maltese: Epoprostenol Sodium, il-monosodium salt ta' epoprostenol, prostaglandin li jinstab b'mod naturali u tipproduċih ir-rita ta' ġewwanett tal-kanali tad-demm.
English: • redness.
Maltese: • uġigħ
English: Intravenous epoprostenol infusions of up to 15 minutes have been found to produce dose-related increases in cardiac index (CI) and stroke volume (SV), and dose-related decreases in pulmonary vascular resistance (PVR), total pulmonary resistance (TPR) and mean systemic arterial pressure (SAPm).
Maltese: Infużjonijiet ta' epoprostenol fil-vina għal mhux aktar minn 15-il minuta nstabu li jipproduċu żidiet marbuta mad-doża fl-indiċi tal-qalb (CI - cardiac index) u fil-volum ta' demm mitfugħ il-barra mill-ventrikulu ma' kull taħbita (SV - stroke volume), u tnaqqis marbut mad-doża fir-reżistenza vaskulari tal-pulmun (PVRpulmonary vascular resistance), fir-reżistenza totali tal-pulmun (TPR - total pulmonary resistance) u filpressjoni sistemika medja tal-arterji (SAPm - mean systemic arterial pressure).
English: The other ingredients are Mannitol, Glycine, Sodium Chloride, Sodium Hydroxide and Water.
Maltese: Is-sustanzi l-oħra huma Mannitol, Glycine, Sodium Chloride, Sodium Hydroxide u Ilma.
English: The half-life for the spontaneous breakdown to 6-oxo-prostaglandin F1 alpha in man is expected to be no more than 6 minutes, and may be as short as 2 to 3 minutes, as estimated from in vitro rates of degradation of epoprostenol in human whole blood.
Maltese: Il-half-life għad-diżintegrazzjoni spontanja ta' 6-oxo-prostaglandin F1 alpha fil-bniedem hija mistennija li tkun ta' mhux aktar minn 6 minuti, u tista' tkun ta' anke 2 jew 3 minuti biss, kif stmat minn rati ta' degradazzjoni ta' epoprostenol in vitro fid-demm sħiħ uman.
English: Flolan is injected into a vein.
Maltese: Flolan jiġi injettat ġo vina.
English: The effects of epoprostenol on platelet aggregation is dose-related when between 2 and 16 nanograms/kg/min is administered intravenously, and significant inhibition of aggregation induced by adenosine diphosphate is observed at doses of 4 nanograms/kg/min and above.
Maltese: L-effetti ta' epoprostenol fuq l-aggregazzjoni tal-plejtlits huma marbutin mad-doża meta jingħataw bejn 2 u 16-il nanogramma/kg/min mill-vina, u inibizzjoni sinifikanti tal-aggregazzjoni indotta permezz ta' adenosine diphosphate hija osservata b'dożi ta' 4 nanogrammi/kg/min u aktar.
English: Powder for solution for infusion: Mannitol, glycine, sodium chloride, sodium hydroxide( for pH adjustment)
Maltese: Trab għal soluzzjoni għall-infużjoni: Mannitol, glycine, sodium chloride, sodium hydroxide (għallaġġustament tal-pH)
English: Each vial contains epoprostenol sodium equivalent to 1.5 mg epoprostenol One ml of reconstituted concentrate solution contains epoprostenol (as epoprostenol ) 30 000 nanogram.
Maltese: Kull kunjett fih epoprostenol sodium ekwivalenti għal 1.5 mg epoprostenol Millilitru wieħed ta' konċentrat tas-soluzzjoni rikostitwita fih 30,000 nanogramma epoprostenol (bħala epoprostenol ) 30,000 nanogramma.
English: Following the administration of radiolabelled epoprostenol to humans, at least 16 metabolites were found, 10 of which were structurally identified.
Maltese: Wara l-għoti ta' epoprostenol radjutikkettat lill-bnedmin, instabu mill-inqas 16-il metabolit, li 10 minnhom ġew identifikati b'mod strutturali.
English: Sixteen patients received 24 epoprostenol dialyses in emergency studies.
Maltese: Sittax-il pazjent irċivew 24 dijalisi b'epoprostenol fi studji ta' emerġenza.
English: • for a maximum of 8 hours if it was made previously and has been stored at 2-8oC.
Maltese: • għal massimu ta' 8 sigħat jekk din tkun ġiet ippreparata qabel u tkun inħażnet f'temperatura ta' 2-8oC.