FrancophonIA/ELRC3.0 huggingface dataset:
English: - Theophylline for asthma - Tizanidine, a muscle relaxant - Oral contraceptives (containing ethinylestradiol and levonorgestrel) - Cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - Indomethacin, ketoprofen for pain or inflammation - Furosemide for heart disease (diuretic, water pill) - Zidovudine for HIV infection - Rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - Sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - Colestyramine (used to lower cholesterol levels and treat itching associated with jaundice) or activated charcoal as these medicines can reduce the amount of Repso absorbed by your body.
Maltese: - Mediċina oħra għall-artrite rewmatojde, bħal mediċini kontra l-malarja (eż. chloroquine u hydroxychloroquine), deheb intramuskolari jew orali, D-penicillamine, azathioprine u mediċini oħrajn li jrażżnu s-sistema immunitarja (eż. methotrexate) għax dawn il-kombinazzjonijiet mhumiex rakkomandati - Warfarin u mediċini orali oħra użati biex iraqqu d-demm, għax ikun hemm bżonn ta'
English: Do not use this medicine after the expiry date that is stated on the outer carton, blister or tablet container after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna ta' barra, folja jew kontenitur tal-pilloli wara EXP.
English: • Each film-coated tablet contains 10 mg of leflunomide.
Maltese: • Kull pillola miksija b'rita fiha 10 mg ta' leflunomide.
English: Read the package leaflet before use.
Maltese: Mhux id-daqsijiet tal-pakkett kollha jistgħu qegħdin fis-suq.
English: - Alosetron for the management of severe diarrhoea - Theophylline for asthma - Tizanidine, a muscle relaxant - Oral contraceptives (containing ethinylestradiol and levonorgestrel) - Cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - Indomethacin, ketoprofen for pain or inflammation - Furosemide for heart disease (diuretic, water pill) - Zidovudine for HIV infection - Rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - Sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - Colestyramine (used to lower cholesterol levels and treat itching associated with jaundice) or activated charcoal as these medicines can reduce the amount of Repso absorbed by your body.
Maltese: monitoraġġ sabiex jitnaqqas ir-riskju ta' effetti sekondarji minn din il-mediċina - Teriflunomide għas-sklerożi multipla - Repaglinide, pioglitazone, nateglinide, jew rosiglitazone għad-dijabete - Daunorubicin, doxorubicin, paclitaxel, jew topotecan għall-kanċer - Duloxetine għad-depressjoni, inkontinenza awrinarja jew għall-mard tal-kliewi fid-dijabetiċi - Alosetron għall-immaniġġar ta' dijarea severa - Theophylline għall-ażma - Tizanidine, rilassant tal-muskoli - Kontraċettivi orali (li fihom ethinylestradiol u levonorgestrel) - Cefaclor, benzylpenicillin (penicillin G), ciprofloxacin għall-infezzjonijiet - Indomethacin, ketoprofen għall-uġigħ jew għall-infjammazzjoni - Furosemide għall-mard tal-qalb (dijuretiku, pillola tal-ilma) - Zidovudine għall-infezzjoni bl-HIV - Rosuvastatin, simvastatin, atorvastatin, pravastatin għall-iperkolesterolimja (kolesterol għoli) - Sulfasalazine għall-mard infjammatorju tal-imsaren jew artrite rewmatojdeja - Colestyramine (użat fil-kura ta' livelli għolja tax-xaħam fid-demm u trattament ta'ħakk assoċjat ma'suffejra) jew charcoal mediċinali attivat billi dawn il-mediċini jistgħu jnaqqsu l ammont ta' Repso li huwa assorbit mill-ġisem.
English: Following concomitant administration of a single dose of leflunomide to subjects receiving multiple doses of rifampicin (non-specific cytochrome P450 inducer) A771726 peak levels were increased by approximately 40 %, whereas the AUC was not significantly changed.
Maltese: Wara t-teħid konkomitanti ta' doża waħda ta' leflunomide, f'pazjenti li kienu qed jieħdu dożi multipli ta' rifampicin (stimulatur mhux speċifiku taċċitokromju P450), il-livelli l-aktar għoljin ta' A771726 żdiedu b'madwar 40%, filwaqt li l-AUC ma nbidlitx b'mod sinifikanti.
English: • Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with leflunomide and thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/l (see section 4.6).
Maltese: • Nisa tqal b'tarbija, jew nisa li jinsabu fl-età li jista' jkollhom it-tfal u mhux qegħdin jużaw kontraċettivi effettivi waqt il-kura b'leflunomide, u wara, sakemm il-livelli fil-plażma talprodott jibqgħu ikunu aktar minn 0.02 mg/l (ara sezzjoni 4.6).
English: Repso 10 mg film-coated tablets leflunomide
Maltese: Repso 10 mg pilloli miksija b'rita leflunomide
English: The duration may be modified depending on clinical or laboratory variables.
Maltese: It-tul ta' żmien jista' jkun modifikat skont il-varjabbli kliniċi u dawk tal-laboratorju.
English: What Repso looks like and contents of the pack Repso 20 mg film-coated tablets are dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Maltese: Il-pilloli miksija b'rita ta' Repso 20 mg huma ta' lewn beġ skuri, f'għamla ta' triangolu u miksija b'rita, u fuqhom hemm intaljat ”20” fuq naħa waħda u “L”fuq in-naħa l-oħra.
English: NAME OF THE MEDICINAL PRODUCT Repso 10 mg film-coated tablets Repso 20 mg film-coated tablets
Maltese: Repso 10 mg pilloli miksija b'rita Repso 20 mg pilloli miksija b'rita
English: Each film-coated tablet contains 10 mg of leflunomide.
Maltese: Kull pillola miksija b'rita fiha 10 mg ta' leflunomide.
English: Repso provided in blisters are available in pack sizes of 28, 30 and 100 film-coated tablets.
Maltese: Il-pilloli ta' Repso pprovduti fil-folji jiġu f'daqsijiet ta' 28 u 30 u 100 pillola miksija b'rita.
English: cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Maltese: nekroliżi tossika tal-ġilda, is-sindrome ta' Stevens-Johnson, eritema multiforme Mhux magħruf lupus eritematożu kutanju, psorijasi pustulari jew il-psorijasi tmur għall-agħar, Reazzjoni għall-Mediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS)
English: Co-administration of teriflunomide with leflunomide is not recommended, as leflunomide is the parent compound of teriflunomide.
Maltese: It-teħid flimkien ta' teriflunomide u leflunomide mhuwiex irrakkomandat peress li leflunomide huwa l-kompost oriġinali ta' teriflunomide.
English: red skin stains, or blisters e.g. Stevens-Johnson syndrome) or any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis).
Maltese: is-sindromu ta' Stevens-Johnson) jew minn xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6) jew jekk inti allerġiku/a għal teriflunomide (użat għall-kura ta' sklerożi multipla).
English: Rheumatoid arthritis
Maltese: Artrite rewmatojdi
English: • Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome.
Maltese: • Pazjenti li għandhom livelli baxxi ħafna tal-proteini fid-demm, eż. is-sindromu nefrotiku.
English: A more than 3-fold increase was seen in another 5 patients.
Maltese: Kien hemm żieda ta' aktar minn 3 darbiet f'5 pazjenti oħra.
English: What Repso looks like and contents of the pack Repso 10 mg film-coated tablets are white, round film-coated tablets, engraved with “10” on one side and “L” on the other.
Maltese: Il-pilloli miksija b'rita ta' Repso 10 mg huma bojod, tondi u fuqhom hemm intaljat “10” fuq naħa waħda u “L” fuq naħa oħra.
English: Repeated oral administration of leflunomide to mice for up to 3 months, to rats and dogs for up to 6 months and to monkeys for up to 1 month's duration revealed that the major target organs for toxicity were bone marrow, blood, gastrointestinal tract, skin, spleen, thymus and lymph nodes.
Maltese: It-teħid orali u repetut ta' leflunomide fil-ġrieden għal perijodu sa 3 xhur, filfirien u l-klieb għal perijodu sa 6 xhur, u fix-xadini għal perijodu ta' xahar, żvela li l-organi maġġuri milquta mit-tossiċità kienu l-mudullun, id-demm, il-passaġġ gastrointestinali, il-ġilda, il-milsa, it-timu u l-glandoli limfatiċi.
English: The concentration may be expected to decrease below 0.02 mg/l about 2 years after stopping the treatment with leflunomide.
Maltese: Il-konċentrazzjoni mistennija li tista' tonqos inqas minn 0.02 mg/l madwar sentejn wara li tintemm il-kura b'leflunomide.
English: EU/1/11/674/001 30 film-coated tablets EU/1/11/674/002 100 film-coated tablets
Maltese: EU/1/11/674/001 30 pilloli miksija b'rita EU/1/11/674/002 100 pilloli miksija b'rita
English: interstitial lung disease (including interstitial pneumonitis), which may be fatal
Maltese: mard interstizzjali tal-pulmun (li jinkludi pnewmonite), li jista' jkun fatali
English: - Ruptured tendons.
Maltese: Mhux applikabbli.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: EU/1/11/674/006 30 film-coated tablets EU/1/11/674/007 100 film-coated tablets
Maltese: EU/1/11/674/006 30 pilloli miksija b'rita EU/1/11/674/007 100 pilloli miksija b'rita
English: Not known side effects (frequency cannot be estimated from the available data) Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility (which is reversible once treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light), psoriasis (new or worsening) and DRESS (see above and section 2) may also occur with an unknown frequency.
Maltese: Effetti sekondarji oħra bħal insuffiċjenza tal-kliewi, tnaqqis fil-livell ta' l-aċidu uriku fid-demm tiegħek, ipertensjoni pulmonari, infertilita' maskili (li hija riversibbli ġaladarba t-trattament b'din ilmediċina titwaqqaf), lupus kutanju (ikkaratterizzat minn raxx/eritema fuq dawk il-partijiet tal-ġilda esposti għax-xemx) psorijasi (tal-ewwel darba jew li tmur għall-agħar) u DRESS (ara hawn fuq u sezzjoni 2) jistgħu jseħħu wkoll b'frekwenza mhux magħrufa.
English: The mechanism is thought to be by interruption of enterohepatic recycling and/or gastrointestinal dialysis of A771726.
Maltese: Il-mekkaniżmu involut huwa maħsub li jinterrompi r-reċiklaġġ enteroepatiku u/jew id-dijaliżi gastrointestinali ta' A771726.
English: Repso 10 mg film-coated tablets
Maltese: Repso 10 mg pilloli miksija b'rita
English: For tablets stored in tablet containers: Do not store above 30°C.
Maltese: Għall-pilloli miżmuma fil-kontenituri tal-pilloli: Taħżinx f'temperatura 'l fuq minn 30°C.
English: agranulocytosis
Maltese: Tfal u adolexxenti
English: - If you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), see section 2.
Maltese: - Jekk tiżviluppa raxx tal-ġilda jew ulċeri f'ħalqek, peress li dawn jistgħu jindikaw reazzjonijiet severi li xi kultant jistgħu jkunu ta' periklu għal ħajja (eż. sindromu ta' Stevens-Johnson, nekrolisi epidermali tossika, eritema multiforme, Reazzjoni għall-Mediċina b'Eosinofilja u Sintomi Sistemiċi [DRESS]), ara sezzjoni 2.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Repso 10 mg film-coated tablets Each film-coated tablet contains 10 mg of leflunomide.
Maltese: Effetti sekondarji komuni (tista' taffettwa sa 1 minn kull 10 persuni) - Żieda ħafifa fil-pressjoni tad-demm.
English: Elimination of A771726 is slow and characterised by an apparent clearance of about 31 ml/hr.
Maltese: L-eliminazzjoni ta' A771726 isir bil-mod u hija karatterizzata bit-tneħħija apparenti ta' madwar 31 ml fis-siegħa.
English: The symptoms include inflammation of joints, swelling, difficulty moving and pain.
Maltese: Is-sintomi jinkludu. infjammazzjoni tal-ġogi, nefħa, diffikultà fil-movimenti u uġigħ.
English: increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin
Maltese: żieda fit-twaqqigħ tax-xagħar, ekżema, raxx (li jinkludi raxx makulopapulari),
English: HDPE tablet container with polypropylene screw cap.
Maltese: Reċipjent tal-HDPE b'għatu tal-kamin tal-polypropylene.
English: Therefore, when warfarin or another coumarin anticoagulant is co-administered, close international normalised ratio (INR) follow-up and monitoring is recommended.
Maltese: Għalhekk, meta jkun hemm ukoll it-teħid ta' warfarin jew ta' antikoagulanti coumarine ieħor, huwa rrakkomandat li l-proporzjon normalizzat internazzjonali (INR) jiġi segwit u mmonitorjat mill-qrib.
English: Binding of A771726 appeared slightly reduced and more variable in plasma from patients with rheumatoid arthritis or chronic renal insufficiency.
Maltese: A771726 għandu volum apparenti ta' distribuzzjoni baxxa (madwar 11-il litru) u dan huwa konsistenti mar-rabta estensiva tiegħu mal-proteina.
English: - Severe liver damage (i.e. liver failure, liver necrosis), which may be fatal.
Maltese: - Ħsara severa fil-fwied (i.e. falliment tal-fwied, nekrosi tal-fwied), li tista' tkun fatali.
English: If both plasma concentrations are below 0.02 mg/l, and after a waiting period of at least 3 months, the risk of foetal toxicity is very low.
Maltese: Jekk illivelli fil-plażma jkunu inqas minn 0.02 mg/l, u wara stennija ta' mhux inqas minn 3 xhur, ir-riskju ta' tossiċità għall-fetu huwa żgħir ħafna.
English: - Dry skin.
Maltese: U LUŻU
English: If used together, the dose of rosuvastatin should not exceed 10 mg once daily.
Maltese: Jekk jintużaw flimkien, id-doża ta' rosuvastatin m'għandhiex taqbeż 10 mg kuljum.
English: Repso provided in tablet containers are available in pack sizes of 30 and 100 film-coated tablets.
Maltese: Il-pilloli ta' Repso pprovduti fil-kontenituri tal-pilloli jiġu f'daqsijiet ta' 30 u 100 pillola miksija b'rita.
English: Cutaneous spray, solution
Maltese: Sprej kutanju, likwidu.
English: (see section 4.4).
Maltese: (ara sezzjoni 4.4),
English: Study ALX0681-C301
Maltese: Studju ALX0681-C301
English: Differences in the different subpopulations were investigated.
Maltese: Id differenzi f'subpopolazzjonijiet differenti kienu investigati.
English: Ablynx NV Technologiepark 21 9052 Zwijnaarde Belgium
Maltese: Ablynx NV Technologiepark 21 9052 Zwijnaarde Il-Belġju
English: Never expose to temperatures above 30 °C.
Maltese: Qatt tesponi għal temperaturi ogħla minn 30°C.
English: N Mean (SE)
Maltese: N Medja (SE)
English: The line can be flushed with 0.9% sodium chloride.
Maltese: Il-linja tista' tiġi mlaħalħa b'0.9% ta' sodium chloride.
English: INFORMATION IN BRAILLE Cablivi
Maltese: INFORMAZZJONI BIL-BRAILLE Cablivi
English: Content :
Maltese: Kontenut:
English: Cablivi is available in
Maltese: Cablivi huwa disponibbli
English: Menorrhagia*, vaginal haemorrhage*
Maltese: Menorraġija*, emorraġija vaġinali*
English: • Multipack containing 7 single packs.
Maltese: • Pakkett multiplu li fih 7 pakketti separati.
English: Total volume of plasma used (liter)
Maltese: Volum totali ta' plażma użat (litru)
English: In case of active clinically significant bleeding, consider actions outlined in sections 4.4 and 4.9.
Maltese: F'każ ta' fsada attiva u klinikament sinifikanti, wieħed għandu jikkunsidra l-azzjonijiet deskritti f'sezzjoni 4.4 u 4.9.
English: Step 1 - Cleaning
Maltese: Pass 1 - Tindif
English: Date removed from refrigerator: ________________________
Maltese: Data meta tneħħa mill-friġġ: ________________________
English: Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti kif ġej: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Treatment with caplacizumab resulted in a 74% reduction in the composite endpoint of the percentage of patients with aTTP-related death (0/72; placebo 3/73), exacerbation of aTTP (3/72; placebo 28/73), or at least one major thromboembolic event during study drug treatment (6/72; placebo 6/73) (p<0.0001).
Maltese: It-trattament b'caplacizumab wassal għal tnaqqis ta' 74% fil-punt finali compost ta' perċentwal ta' pazjenti b'mewt relatata ma' aTTP (0/72; plaċebo 3/73), aTTP tmur għall-agħar (3/72; plaċebo 28/73), jew mill-inqas episodju wieħed tromboemboliku maġġuri matul it-trattament bil-mediċina tal-istudju (6/72; plaċebo 6/73) (p<0.0001).
English: In patients with aTTP the central volume of distribution was estimated at 6.33 L.
Maltese: F'pazjenti b'aTTP, il-volum ċentrali tad-distribuzzjoni kien stmat li hu ta' 6.33 L.
English: 9052 Zwijnaarde, Belgium
Maltese: 9052 Zwijnaarde, Il-Belġju
English: LIST OF EXCIPIENTS Excipients: sucrose, citric acid anhydrous, trisodium citrate dihydrate, polysorbate 80.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: sucrose, citric acid anhydrous, trisodium citrate dihydrate, polysorbate 80.
English: N: number of patients evaluated; SE: Standard Error; ICU: Intensive Care Unit
Maltese: Standard Error; ICU:
English: Haematoma*
Maltese: Ematoma*
English: See section 4.4 for special considerations in patients with severe hepatic impairment.
Maltese: Ara sezzjoni 4.4 għal konsiderazzjonijiet speċjali f'pazjenti b'indeboliment epatiku sever.
English: Unopened vial 4 years.
Maltese: Kunjett mhux miftuħ 4 snin.
English: The efficacy and safety of caplacizumab in adults experiencing an episode of aTTP were established in 2 randomised, controlled studies: Phase III study ALX0681-C301 “HERCULES” and Phase II study ALX-0681-2.1/10 “TITAN”.
Maltese: III ALX0681-C301 “HERCULES” u studju ta' Fażi II ALX-0681-2.1/10 “TITAN”.
English: Date of first authorisation: 31 August 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 31 ta' Awwissu, 2018
English: Haematuria*
Maltese: Ematurija*
English: Gingival bleeding* Haematemesis*, haematochezia*, melaena*, upper gastrointestinal haemorrhage*, haemorrhoidal haemorrhage*, rectal haemorrhage *, abdominal wall haematoma*
Maltese: Ematemesi*, ematokeżija, melaena*, emorraġija gastrointestinali fil-parti ta' fuq*, emorraġija tal-murliti*, emorraġija fir-rektum*, ematoma fil-ħajt addominali*
English: It is used to treat an episode of acquired thrombotic thrombocytopenic purpura in adults.
Maltese: Jintuża biex jittratta episodju ta' purpura tromboċitopenika trombotika akkwistata fl-adulti.
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 4 sigħat f'temperatura ta' 25°C.
English: After subcutaneous administration, caplacizumab is rapidly and almost completely absorbed (estimated F> 0.901) in the systemic circulation.
Maltese: Wara għoti taħt il-ġilda, caplacizumab jiġi assorbit malajr u kważi kompletament (F> 0.901 stmat ) fiċ-ċirkolazzjoni sistemika.
English: Step 12 - Administration
Maltese: Pass 12 - Għoti
English: In the population PK/PD model, renal function (CRCL) had a statistically significant effect resulting in limited increase in predicted exposure (AUCss) in severe renal impairment.
Maltese: Fil-mudell tal-popolazzjoni PK/PD, il-funzjoni renali (CRCL) kellha effett statistikament sinifikanti li wassal għal żieda limitata fl-espożizzjoni mistennija (AUCss) f'indeboliment renali sever.
English: Cablivi 10 mg powder and solvent for solution for injection caplacizumab
Maltese: Cablivi 10 mg trab u solvent għal soluzzjoni għall-injezzjoni caplacizumab
English: Caplacizumab is a humanised bivalent Nanobody that consists of two identical humanised building blocks (PMP12A2hum1), genetically linked by a three-alanine linker, targeting the A1-domain of von Willebrand factor and inhibiting the interaction between von Willebrand factor and platelets.
Maltese: Caplacizumab huwa Nanobody bivalenti umanizzat li jikkonsisti f'żewġ komponenti identiċi umanizzati (PMP12A2hum1), magħquda ġenetikament permezz ta' linker ta' tliet alanines, li jimmira r-reġjun A1 tal-fattur von Willebrand u jinibixxi l-interazzjoni bejn il-fattur von Willebrand u lplejtlits.
English: For instructions on reconstitution of Cablivi before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni ta' Cablivi qabel jingħata, ara sezzjoni 6.6.
English: • Remove the plastic flip-off cap from the vial.
Maltese: • Neħħi l-għatu flip-off tal-plastik mill-kunjett.
English: • Multidose pack containing 7 vials with powder, 7 pre-filled syringes with solvent, 7 vial adapters, 7 hypodermic needles (30 gauge) and 14 alcohol swabs.
Maltese: • Pakkett ta' ħafna dożi li fih 7 kunjetti bit-trab, 7 siringi mimlijin għal-lest bis-solvent, 7 adapters tal-kunjett, 7 labar ipodermiċi (gejġ ta' 30) u 14-il biċċa ta' tajjar imxarrbin bl-alkoħol.
English: Full inhibition of von Willebrand factor-mediated platelet aggregation by caplacizumab is indicated by RIPA and RICO levels dropping below 10% and 20%, respectively.
Maltese: Inibizzjoni sħiħa tal-aggregazzjoni tal-plejtlits permezz tal-fattur von Willebrand b'caplacizumab hija indikata mit-tnaqqis fil-livelli ta' RIPA u RICO li jaqgħu taħt 10% u 20%, rispettivament.
English: Name and address of the manufacturer of the biological active substance Richter-Helm BioLogics GmbH & Co. KG Dengelsberg
Maltese: Richter-Helm BioLogics GmbH & Co.
English: In this study, 145 patients experiencing an episode of aTTP were randomised (72 to caplacizumab and to 73 placebo).
Maltese: F'dan l-istudju, 145 pazjent li kellhom episodju ta' aTTP ġew magħżula b'mod każwali (72 għal caplacizumab u 73 għal plaċebo).
English: Vial (type I glass) with a stopper (butyl rubber), a seal (aluminium) and a cap (polypropylene), containing 10 mg of caplacizumab.
Maltese: Kunjett (ħġieġ tat-tip I) b'tapp (lastku butyl), siġill (polypropylene) u għatu (polypropylene), li jkun fih 10 mg ta' caplacizumab.
English: The plunger may rise up by itself again - this is normal.
Maltese: Il-planġer jista' jerġa' jitla' waħdu - dan huwa normali.
English: A risk to the child cannot be excluded.
Maltese: Ir-riskju gћat-trabi tat-twelid mhux eskluż.
English: Dyspnoea, Haemoptysis*
Maltese: Qtugħ ta' nifs, Eemoptisi*
English: Patient age ranged from 18 to 79 years, with a mean of 46 years.
Maltese: L-età tal-pazjenti kienet tvarja minn 18 sa 79 sena, b'medja ta' 46 sena.
English: • are using anticoagulants such as vitamin K antagonists , rivaroxaban, apixaban (which treat blood clots).
Maltese: • qed tuża antikoagulanti bħal antagonisti tal-vitamina K, rivaroxaban, apixaban (li jittrattaw iċ ċapep fid-demm).
English: The pharmacologic effect of caplacizumab on target inhibition was assessed using two biomarkers for von Willebrand factor activity; ristocetin-induced platelet aggregation (RIPA) and ristocetin cofactor (RICO).
Maltese: L-effett farmakoloġiku ta' caplacizumab dwar l-inibizzjoni mmirata kien evalwat bl-użu ta' żewġ bijomarkaturi għall-attività tal-fattur von Willebrand; aggregazzjoni tal-plejtlits fuq stimulazzjoni minn ristocetin (RIPA- ristocetin-induced platelet aggregation) u l-kofattur ristocetin (RICOristocetin cofactor).
English: • Go to step 8 immediately after these 5 minutes.
Maltese: • Għaddi għal pass 8 immedjatament wara dawn il-5 minuti.
English: • multipacks each containing 7 single packs
Maltese: • f'pakketti multipli li kull wieħed fih 7 pakketti separati