FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Guide for healthcare professionals shall contain the following key elements: o To address the risks of meningococcal infection, serious haemolysis after drug discontinuation in PNH patients, immunogenicity, serious infections, malignancies and haematological abnormalities, use in pregnant and breast-feeding women.
Maltese: • Il-Gwida għall-professjonisti fil-qasam tal-kura tas-saħħa għandu jkun fiha l-elementi ewlenin li ġejjin: o Biex jiġu indirizzati r-riskji ta' infezzjoni meningokokkali, emolisi serja wara t-twaqqif tal-mediċina f'pazjenti b'PNH, immunoġeniċità, infezzjonijiet serji, tumuri malinni u anormalitajiet ematoloġiċi, użu f'nisa tqal u li qed ireddgħu.
English: The prepared solution should be administered immediately following preparation.
Maltese: - Is-soluzzjoni ppreparata għandha tingħata immedjatament wara l-preparazzjoni.
English: You should also be aware that vaccination may not always prevent this type of infection.
Maltese: Għandek tkun konxju wkoll li t-tilqima mhux dejjem tippreveni din it-tip ta' infezzjoni.
English: The majority of the complement-inhibitor naïve study population was highly haemolytic at baseline; 86.2 % of enrolled patients presented with elevated LDH ≥ 3 × ULN, which is a direct measurement of intravascular haemolysis, in the setting of PNH.
Maltese: Il-maġġoranza tal-popolazzjoni tal-istudju dwar pazjenti li qatt ma ġew ikkurati fil-passat b'inibitur tal-komplement kienet emolitika ħafna fil-linja bażi; 86.2% tal-pazjenti rreġistrati ppreżentaw LDH elevata ta' ≥ 3 × ULN, li hija kejl dirett ta' emolisi intravaskulari, fil-kuntest ta' PNH.
English: Instructions for proper use Ultomiris is given by infusion (drip) into a vein.
Maltese: Istruzzjonijiet biex tużah kif suppost Ultomiris jingħata bħala infużjoni (dripp) ġo vina.
English: Chest pain, or angina,
Maltese: Għeja kbira,
English: Body weight range (kg)
Maltese: Medda ta' piż tal-ġisem (kg)
English: Nonclinical reproductive toxicology studies conducted in mice with the murine surrogate molecule BB5.1 identified no adverse effect to pups resulting from consuming milk from treated dams.
Maltese: Studji dwar ittossikoloġija riproduttiva mhux kliniċi li twettqu fil-ġrieden bil-molekula murine surrogate BB5.1 ma identifikaw l-ebda effetti avversi lill-frieħ li rriżultaw mill-konsum ta' ħalib minn ommijiet (firien nisa) ittrattati.
English: The safety and efficacy of ravulizumab in patients with PNH were assessed in two open-label, randomised, active-controlled Phase 3 trials: a complement-inhibitor naïve study in adult patients with PNH who were naïve to complement inhibitor treatment, an eculizumab -experienced study in patients with PNH who were clinically stable after having been treated with eculizumab for at least the previous 6 months.
Maltese: Is-sigurtà u l-effikaċja ta' ravulizumab f'pazjenti b'PNH ġew evalwati f'żewġ provi ta' Fażi 3 openlabel, fejn il-pazjenti ntgħażlu b'mod każwali u kkontrollati b'mod attiv: studju dwar pazjenti li qatt ma ġew ikkurati fil-passat b'inibitur tal-komplement f'pazjenti adulti b'PNH li qatt ma rċivew trattament b'inibitur tal-komplement, studju dwar pazjenti li ġew ikkurati fil-passat b'eculizumab f'pazjenti b'PNH li kienu klinikament stabbli wara li ġew ittrattati b'eculizumab għal mill-inqas is-6 xhur preċedenti.
English: Table 6: Loading dose administration reference table Body weight range (kg)a
Maltese: Tabella 6: Tabella ta' referenza għall-għoti ta' doża qawwija tal-bidu Medda ta' piż tal-ġisem (kg)
English: Ravulizumab was non-inferior compared to eculizumab for the primary endpoint, percent change in LDH from baseline to day 183, and for all 4 key secondary endpoints (Figure 2).
Maltese: Ravulizumab ma kienx inferjuri meta mqabbel ma' eculizumab għall-punt tat-tmiem primarju, il-bidla perċentwali fl-LDH mil-linja bażi sa jum 183, u għall-4 punti tat-tmiem sekondarji ewlenin kollha (Figura 2).
English: • The patient guide shall contain the following key messages: o To address the risks of meningococcal infection, serious haemolysis after drug discontinuation in PNH patients, immunogenicity, serious infections, malignancies and haematological abnormalities, use in pregnant and breast-feeding women.
Maltese: • Il-gwida għall-pazjent jkun fiha l-messaġġi ewlenin li ġejjin: o Biex jiġu indirizzati r-riskji ta' infezzjoni meningokokkali, emolisi serja wara t-twaqqif tal-mediċina f'pazjenti b'PNH, immunoġeniċità, infezzjonijiet serji, tumuri malinni u anormalitajiet ematoloġiċi, użu f'nisa tqal u li qed ireddgħu.
English: Cases of serious or fatal meningococcal infections/sepsis have been reported in patients treated with other terminal complement inhibitors.
Maltese: Każijiet ta' infezzjonijiet meningokokkali/sepsi serji jew fatali kienu rrappurtati f'pazjenti ttrattati b'inibituri tal-komplement terminali.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali mhux biżżejjed biex juru xi effetti tossiċi fuq issistema riproduttiva (ara sezzjoni 5.3).
English: o The risk of immunogenicity with ravulizumab, including anaphylaxis, and the need for clinical monitoring post-infusion.
Maltese: o Ir-riskju ta' immunoġeniċità minħabba ravulizumab, li jinkludu anafilassi, u l-ħtieġa għal monitoraġġ kliniku wara l-infużjoni.
English: Figure 1: Analysis of coprimary and secondary endpoints - Full analysis set (complementinhibitor naïve study)
Maltese: Figura 1: Analiżi ta' punti tat-tmiem koprimarji u sekondarji - Sett sħiħ ta' analiżi (studju dwar pazjenti li qatt ma ġew ikkurati fil-passat b'inibitur tal-komplement)
English: NAME OF THE MEDICINAL PRODUCT Ultomiris 300 mg concentrate for solution for infusion
Maltese: Ultomiris 300 mg konċentrat għal soluzzjoni għall-infużjoni
English: If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal infection symptoms), you should immediately inform your doctor.
Maltese: Jekk ikollok xi wieħed mis-sintomi ta' infezzjoni meningokokkali (ara sezzjoni 2 Sintomi ta' infezzjoni meningokokkali), għandek tinforma lit-tabib tiegħek immedjatament.
English: Do not administer Ultomiris as an intravenous push or bolus injection.
Maltese: 3- Għoti - Tagħtix Ultomiris bħala push ġol-vina jew injezzjoni bolus.
English: Ultomiris should be only diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection
Maltese: Ultomiris għandu jiġi dilwit biss bl-użu ta' soluzzjoni għall-injezzjoni tas-sodium chloride 9 mg/mL (0.9%)
English: Serious meningococcal infection
Maltese: Infezzjoni meningokokkali serja
English: No clear treatment-related effects or adverse effects were observed in the murine surrogate reproductive toxicology studies in mice.
Maltese: Ma ġew osservati l-ebda effetti ċari marbuta mat-trattament jew effetti avversi fl-istudji dwar it-tossikoloġija riproduttiva bil-murine surrogate fil-ġrieden.
English: To reduce this risk of infection, all patients must be vaccinated against meningococcal infections at least two weeks prior to initiating ravulizumab unless the risk of delaying ravulizumab therapy outweighs the risk of developing a meningococcal infection.
Maltese: Biex jitnaqqas ir-riskju ta' infezzjoni, il-pazjenti kollha jridu jitlaqqmu għal kontra infezzjonijiet meningokokkali mill-inqas ġimagħtejn qabel ma jinbeda ravulizumab sakemm ir-riskju li tkun imdewma t-terapija b'ravulizumab ma jiżboqx ir-riskju li wieħed jiżviluppa infezzjoni meningokokkali.
English: The 12-month transfusion history was similar between ravulizumab and eculizumab treatment groups and more than 87 % of patients in both treatment groups had not received a transfusion within 12 months of study entry.
Maltese: L-istorja medika ta' trasfużjoni ta' 12-il xahar kienet simili bejn il-gruppi ta' trattatment ta' ravulizumab u eculizumab u aktar minn 87% tal-pazjenti fiż-żewġ gruppi ta' trattament ma kinux irċivew trasfużjoni fi żmien 12-il xahar li daħlu fl-istudju.
English: Secondary endpoints included the proportion of patients with breakthrough haemolysis, quality-of-life (FACITFatigue), transfusion avoidance (TA), and proportion of patients with stabilised haemoglobin.
Maltese: Il-punti tat-tmiem sekondarji kienu jinkludu l-proporzjon ta' pazjenti b'emolisi li sseħħ f'daqqa, ilkwalità tal-ħajja (FACIT-Fatigue), l-evitar ta' trasfużjoni (TA, transfusion avoidance), u l-proporzjon ta' pazjenti b'emoglobina stabbilizzata.
English: Pregnancy/ Breast-feeding
Maltese: Bidla fil-FACIT Fatigue
English: Following ravulizumab treatment in both complement-inhibitor naïve patients and eculizumab-experienced patients with PNH in Phase 3 studies, immediate and complete inhibition of serum free C5 (concentration of < 0.5 µg/mL) was observed by the end of the first infusion and sustained throughout the entire 26-week treatment period in all patients.
Maltese: Wara t-trattament b'ravulizumab kemm fil-pazjenti li qatt ma ġew ikkurati fil-passat b'inibitur talkomplement u kif ukoll fil-pazjenti li ġew ikkurati fil-passat b'eculizumab b'PNH fl-istudji ta' Fażi 3, kienet osservata inibizzjoni immedjata u kompleta ta' C5 ħielsa mis-serum (konċentrazzjoni ta' < 0.5 µg/mL) fit-tmiem tal-ewwel infużjoni u ġiet sostnuta fil-perjodu kollu ta' 26 ġimgħa ta' trattament fil-pazjenti kollha.
English: Table 5 presents the baseline characteristics of the PNH patients enrolled in the eculizumabexperienced study, with no apparent clinically meaningful differences observed between the treatment arms.
Maltese: Tabella 5 turi l-karatteristiċi fil-linja bażi tal-pazjenti b'PNH irreġistrati fl- istudju dwar pazjenti li qatt ma ġew ikkurati fil-passat b'inibitur tal-komplement, mingħajr ebda differenzi klinikament sinifikanti apparenti osservati bejn il-gruppi tat-trattament.
English: If you have meningococcal infection.
Maltese: Sintomi ta' infezzjoni meningokokkali
English: Withdraw the required amount of Ultomiris from the vial(s) using a sterile syringe.
Maltese: - Ittrasferixxi d-doża rakkomandata għal borża tal-infużjoni.
English: o The need to explain to and ensure understanding of by patients: o the risk of treatment with ravulizumab (including potential risks of serious infections and malignancies and haematologic abnormalities) o the signs and symptoms of meningococcal infection and what action to take o the patient's guides and their contents o the need to carry the patient safety card and to tell any healthcare practitioner that he/she is receiving treatment with ravulizumab o the requirement for pre-treatment vaccinations/antibiotic prophylaxis o the enrolment in the PNH registry o Details of the PNH registry and how to enter patients
Maltese: o Il-ħtieġa li tispjega lil pazjenti u li taċċerta ruħek li jkunu qed jifhmu dak li qed tispjagalhom: o ir-riskju tal-kura b'ravulizumab (li jinkludi riskji potenzjali ta' infezzjonijiet serji u tumuri malinni u anormalitajiet ematoloġiċi) o Sinjali u s-sintomi ta' infezzjoni meningokokkali u liema azzjoni għandha tittieħed o il-gwidi għall-pazjent u l-kontenut tagħhom o il-ħtieġa li jżommu fuqhom il-kard tas-sigurtà tal-pazjent u biex jgħidu lil kwalunkwe professjonist fil-qasam tal-kura tas-saħħa li hu/hi qed jirċievu t-trattament b'ravulizumab o il-ħtieġa għal tilqim/profilassi antibijotika qabel it-trattament o ir-reġistrazzjoni fir-reġistri tal-PNH o Dettalji tar-reġistri tal-PNH u kif tirreġistra l-pazjenti
English: Women of childbearing potential should use effective contraception methods during treatment and up to 8 months after treatment.
Maltese: Nisa li jistgħu joħorġu tqal għandhom jużaw metodi ta' kontraċezzjoni effettivi waqt it-trattament u sa 8 xhur wara t-trattament.
English: Pre-treatment LDH levels
Maltese: Normalizzazzjoni ta' LDH
English: o Enrolment in the PNH registry.
Maltese: o Reġistrazzjoni fir-reġistru tal-PNH
English: The calculated volume of medicinal product is withdrawn from the appropriate number of vials and diluted in an infusion bag using sodium chloride 9 mg/mL (0.9 %) solution for injection as diluent.
Maltese: Il-volum ikkalkulat tal-prodott mediċinali jinġibed lura minn numru xieraq ta' kunjetti u jiġi dilwit f'borża tal-infużjoni bl-użu ta' soluzzjoni għall-injezzjoni tas-sodium chloride 9 mg/mL (0.9%) bħala dilwent.
English: One vial of 30 mL contains 300 mg of ravulizumab.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed ta' 30 mL fih 300 mg ta' ravulizumab.
English: PNH is a chronic disease and treatment with ravulizumab is recommended to continue for the patient's lifetime, unless the discontinuation of ravulizumab is clinically indicated (see section 4.4).
Maltese: PNH hija marda kronika u t-trattament b'ravulizumab huwa rakkomandat li jkompli tul il-ħajja kollha tal-pazjent, ħlief jekk it-twaqqif ta' ravulizumab ikun klinikament indikat (ara sezzjoni 4.4).
English: o The risk of immunogenicity and advice on post-infusion monitoring.
Maltese: o Ir-riskju ta' immunoġeniċità u parir dwar il-monitoraġġ wara l-infużjoni.
English: *Meningococcal infection includes preferred terms of meningococcal infection and meningococcal sepsis
Maltese: Astenija *Infezzjoni meningokokkali tinkludi t-termini preferuti ta' infezzjoni meningokokkali u sepsi meningokokkali
English: Ultomiris should only be diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection.
Maltese: Id-dilwizzjoni għandha tuża biss soluzzjoni għall-injezzjoni tas-sodium chloride 9 mg/mL (0.9%) bħala dilwent.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Alexion Europe SAS
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Alexion Europe SAS
English: INFORMATION IN BRAILLE Justification for not including braille accepted.
Maltese: Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata.
English: Vomiting, Nausea, Diarrhoea, Abdominal pain, Dyspepsia
Maltese: Uġigħ addominali, Dispepsija
English: Ravulizumab therapy should be administered with caution to patients with active systemic infections.
Maltese: Terapija b'ravulizumab għandha tingħata b'attenzjoni lil pazjenti b'infezzjonijiet sistemiċi attivi.
English: Upper respiratory tract infection Common cold (nasopharyngitis)
Maltese: Infezzjoni fin-naħa ta' fuq tal-passaġġ respiratorju Riħ normali (nażofarinġite)
English: EXP
Maltese: Sturdament
English: Meningococcal infections in patients treated with ravulizumab presented as meningococcal sepsis.
Maltese: Inti tista' tgħin billi tirrapporta kwalunkwe effett sekondarju li jista' jkollok.
English: Antigenic mass ELISA units.
Maltese: 1 Massa antiġenika ELISA units.
English: - L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
Maltese: L. interrogans serogroup Australis serovar Bratislava strejn As-05-073)
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Maltese: L. kirschneri serogrupp Grippotyphosa serovar Dadas strejn Gr-01-005)
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Maltese: L. interrogans serogrupp Icterohaemorrhagiae serovar openhageni (strejn Ic-02-001)
English: 1 vial
Maltese: Qawwa
English: Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portland-vere
Maltese: L. interrogans serogrupp Canicola serovar Portland-vere strejn Ca-12-000)
English: 120 to 249
Maltese: 120 sa 249
English: - Dermatitis allergic
Maltese: - Dermatite allerġika
English: 2.82 to 5.65
Maltese: 2.82 sa 5.65
English: Serum creatinine μmol/l mg/10 ml
Maltese: Krejatinina fis-serum μmol/l mg/10 ml
English: 250 to 500
Maltese: 250 sa 500
English: Possible side Effects
Maltese: Effetti sekondarji possibbli
English: 1.35 to 2.82
Maltese: 1.35 sa 2.82
English: MedDRA System Organ Class
Maltese: Sistema tal-klassifika talorgani
English: The initial volume of distribution is about 9 to 12 liters.
Maltese: Il-volum inizjali tad-distribuzzjoni huwa ta' madwar 9 sa 12-il litru.
English: Disseminated intravascular coagulation
Maltese: Koagulazzjoni intravaskulari mxerrda
English: • effects on the nervous system: convulsions
Maltese: • effetti fuq is-sistema nervuża: aċċessjonijiet
English: Characteristically, the haematological profile approximates to the following: reduced euglobulin clot lysis time; prolonged prothrombin time; reduced plasma levels of fibrinogen, factors V and VIII, plasminogen fibrinolysin and alpha-2 macroglobulin; normal plasma levels of P and P complex; i.e. factors II (prothrombin), VIII and X; increased plasma levels of fibrinogen degradation products; a normal platelet count.
Maltese: B'mod karatteristiku, il-profil ematoloġiku jiġi viċin dan li ġej: tnaqqis fil-ħin taleuglobulin clot lysis; ħin tal-protrombin imtawwal; livelli mnaqqsa tal-fibrinogen fil-plażma, fatturi V u VIII, plasminogen fibrinolysin u alfa-2 macroglobulin; livelli normali tal-kumplessi P u P filplażma; i.e. fatturi II (protrombin), VIII u X; livelli ogħla tal-prodotti ta' degradazzjoni talfibrinogen fil-plażma; għadd normali tal-plejtlits.
English: Visual disturbances
Maltese: Disturbi Viżwali
English: Renal clearance is equal to plasma clearance (110 to 116 mL/min).
Maltese: It-tneħħija renali hija ugwali għal tneħħija mill-plażma (110 sa 116 ml/min).
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur [Ara Anness I - Biex titkompla fil-pajjiż partikolari] {Isem u indirizz} <{telefon}> <{fax}> <{e-mail}>
English: Intrathecal and intraventricular injection, intracerebral application (risk of cerebral oedema and convulsions)
Maltese: • Injezzjoni intratekali u injezzjoni intraventrikulari, applikazzjoni intraċerebrali (riskju ta' edima ċerebrali u aċċessjonijiet)
English: Most of them were controlled versus placebo.
Maltese: Ħafna minnhom ġew ikkontrollati ma' plaċebo.
English: 5.2 Pharmacokinetic properties
Maltese: .2 Proprjetajiet farmokokinetiċi
English: Standard treatment of local fibrinolysis: 0.5 g (1 ampule of 5 ml) to 1 g (1 ampule of 10 ml or 2 ampules of 5 ml) tranexamic acid by slow intravenous injection (= 1 ml/minute) two to three times daily 2.
Maltese: Kura standard għal fibrinoliżi lokali: 0.5 g (ampulla waħda ta' 5 ml) sa 1 g (ampulla waħda ta' 10 ml jew 2 ampulli ta' 5 ml) tranexamic acid mogħtija b'injezzjoni fil-vina bil-mod (= 1 ml/minuta) darbtejn jew tliet darbiet kuljum 2.
English: Standard treatment of general fibrinolysis: 1 g (1 ampule of 10 ml or 2 ampules of 5 ml) tranexamic acid by slow intravenous injection (= 1 ml/minute) every 6 to 8 hours, equivalent to 15 mg/kg BW
Maltese: Kura standard għal fibrinoliżi ġenerali: 1 g (ampulla waħda ta' 10 ml jew 2 ampulli ta' 5 ml) tranexamic acid mogħtija b'injezzjoni fil-vina bil-mod (= 1 ml/minuta) kull 6 jew 8 sigħat, ekwivalenti għal 15 mg/kg tal-piż talġisem
English: • medicines that prevent blood clotting, called thrombolytic medicines
Maltese: • mediċini li jipprevjenu t-tagħqid fid-demm, magħrufa bħala mediċini trombolitiċi
English: Tabulated list of adverse reactions
Maltese: Lista b'forma tabulari ta' reazzjonijiet avversi
English: Pharmacotherapeutic group: Antihemorrhagics, Antifibrinolytics ATC code: B02AA02
Maltese: Mediċini kontra l-emorraġija, mediċini kontra l-fibrinoliżi Kodiċi ATC:
English: Common (may affect up to 1 in 10 users) • effects on the stomach and intestines: nausea, vomiting, diarrhoea
Maltese: Komuni (jista' jaffettwaw minn 1 sa 10 utenti) • effetti fuq l-istonku u l-intestini: dardir, rimettar, dijarea
English: There is a theoretical risk of increased thrombus-formation potential, such as with oestrogens.
Maltese: Hemm riskju tejoretiku ta' potenzjal ogħla li jifforma trombu, bħal per eżempju ma' estroġeni.
English: 10 mg/kg BW Every 24 hours 5 mg/kg BW
Maltese: 10 mg/kg tal-piż talġisem
English: • have kidney problems.
Maltese: • għandek problemi fil-kliewi
English: Alternatively, the antifibrinolytic action of the drug may be antagonised with thrombolytic drugs.
Maltese: Alternativament, l-effett antifibrinolitiku tal-mediċina jista' jkun antagonizzat b'mediċini trombolitiċi.
English: Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not know (can not be estimated from the available data).
Maltese: Il-frekwenza hija mfissra hekk: komuni ħafna (1/10); komuni (1/100 sa 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: • effects on the immune system : allergic reactions
Maltese: • effetti fuq is-sistema immunitarja: reazzjonijiet allerġiċi
English: A complex involving tranexamic acid, plasminogen is constituted; the tranexamic acid being linked to plasminogen when transformed into plasmin.
Maltese: Jiġi ffurmat kumpless li jinkludi tranexamic acid u plasminogen, it-tranexamic acid ikun marbut mal-plasminogen meta dan jiġi trasformat fi plasmin.
English: In patients with a history of thromboembolic diseases or in those with increased incidence of thromboembolic events in their family history (patients with a high risk of thrombophilia), Tranexamic acid solution for injection should only be administered if there is a strong medical indication after consulting a physician experienced in hemostaseology and under strict medical supervision (see section 4.3).
Maltese: F'pazjenti bi storja ta' mard tromboembolitiku jew f'dawk li għandhom inċidenza akbar li jkollhom avvenimenti tromboembolitiċi fl-istorja tal-familja tagħhom (pazjenti b'riskju kbir ta' trombofilja), Tranexamic acid soluzzjoni għall-injezzjoni għandu jingħata biss jekk hemm indikazzjoni medika qawwija u wara li jiġi kkonsultat tabib li għandu esperjenza fl-emostasijoloġija u taħt sorveljanza medika stretta (ara sezzjoni 4.3).
English: Hypersensitivity to the active substance or to any of its excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: The most adapted dosing schedule appeared to be: - first bolus of 10 mg/kg after induction of anaesthesia and prior to skin incision, - continuous infusion of 10 mg/kg/h or injection into the CPB pump prime at a dose adapted on the CPB procedure, either according to a patient weight with a dose of 10 mg/kg dose, either according to CPB pump prime volume, last injection of 10 mg/kg at the end of CPB.
Maltese: - infużjoni kontinwa ta' 10mg/kg/h jew injezzjoni fil-pompa prima CPB b'doża adattata fuq ilproċedura CPB, jew skont il-piż tal-pazjent b'doża ta' 10 mg/kg, jew skont il-volum tal-pompa prima CPB, u l-aħħar injezzjoni ta' 10 mg/kg fl-aħħar tal-CPB.
English: Excretion of tranexamic acid is about 90% within the first 24 hours after intravenous administration of 10 mg/kg body weight.
Maltese: Eliminazzjoni ta' tranexamic acid hija ta' madwar 90% fl-ewwel 24 siegħa wara infużjoni fil-vina ta' 10 mg/kg tal-piż tal-ġisem.
English: Not know (frequency cannot be estimated from the available data)
Maltese: Mhux magħruf (frekwenza ma tistax tiġi stabbilita mid-dejta disponibbli)
English: Fertility: There are no clinical data on the effects of Tranexamic acid on fertility.
Maltese: M'hemmx dejta klinika fuq l-effetti ta' Tranexamic acid fuq il-fertilità.
English: Urinary excretion via glomerular filtration is the main route of elimination.
Maltese: Il-mod prinċipali ta' eliminazzjoni hu mis-sistema urinarja permezz ta' filtrazzjoni glomerulari.
English: Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis (See section 4.5.
Maltese: Tranexamic acid għandu jiġi amministrat b'attenzjoni f'pazjenti li qed jieħdu kontraċettivi orali għax hemm riskju akbar ta' trombożi (Ara sezzjoni 4.5).