FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 vial: 2000 IU rurioctocog alfa pegol, 400 IU/ml after reconstitution.
Maltese: IU rurioctocog alfa pegol, 400 IU/mL wara r-rikostituzzjoni.
English: ADYNOVI can be used only in adolescents and adults (12 years and above).
Maltese: ADYNOVI jista' jintuża biss fl-adolexxenti u adulti (12-il sena u aktar).
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 5 ml of sterilised water for injections.
Maltese: Kunjett tal-ħġieġ ta' tip I, magħluq b'tapp tal-gomma tal-chlorobutyl, li fih 5 mL ta' ilma sterilizzat għall-injezzjonijiet.
English: One hundred eighteen of 120 (98%) prophylaxis subjects remained on the starting recommended regimen without dose adjustment, and 2 subjects increased their dose to 60 IU/kg during prophylaxis due to bleeding in target joints.
Maltese: Mija u tmintax minn 120 (98%) tal-individwi profilassi baqgħu fuq il-kors rakkomandat talbidu mingħajr aġġustament fid-doża, u 2 individwi għollew id-doża tagħhom għal 60
English: What ADYNOVI contains - The active substance is rurioctocog alfa pegol (pegylated human coagulation factor VIII
Maltese: X'fih ADYNOVI - Is-sustanza attiva hija rurioctocog alfa pegol (fattur VIII pegilat tal-koagulazzjoni tal-bniedem magħmul minn teknoloġija tad-DNA rikombinanti).
English: Thus it was not possible to conclude on the potential risks of PEG accumulation in various tissues/organs relevant for chronic use of ADYNOVI in the paediatric population.
Maltese: Għalhekk, ma kienx possibbli li wieħed jasal għal konklużjoni fuq ir-riskji potenzjali ta' akkumulazzjoni ta' PEG f'diversi tessuti/l-organi rilevanti għall-użu kroniku ta' ADYNOVI fil-popolazzjoni pedjatrika.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r­riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Repeat injections every 12 to 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Maltese: Irrepeti l-injezzjonijiet kull 12 sa 24 siegħa għal 3 - 4 ijiem jew aktar sakemm l-uġigħ u d-diżabilità akuta jgħaddu.
English: Post-authorisation safety study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a post-authorisation safety study according to an agreed protocol.
Maltese: Studju dwar is-sigurtà wara l-awtorizzazzjoni (PASS, Post-authorisation safety study): Sabiex jinvestiga l-effetti potenzjali ta' akkumulazzjoni ta' PEG fil-choroid plexus tal-moħħ u ta' tessuti/organi oħrajn, l-MAH għandu jwettaq u jissottometti rriżultati ta' studju dwar is-sigurtà wara l-awtorizzazzjoni skont protokoll miftiehem.
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 2 ml of sterilised water for injections.
Maltese: Kunjett tal-ħġieġ ta' tip I, magħluq b'tapp tal-gomma tal-chlorobutyl, li fih 2 mL ta' ilma sterilizzat għall-injezzjonijiet.
English: The safety of ADYNOVI was evaluated in 38 subjects < 6 years and 34 subjects 6 to < 12 years of age having accumulated a total of 2880 EDs and 2975 EDs respectively.
Maltese: Is-sigurtà ta ADYNOVI ġiet evalwata fi 38 individwu li kellhom < 6 snin u f'34 individwu li kellhom minn 6 sa < 12-il sena, li akkumulaw total ta' 2880
English: 1 vial: 1000 IU rurioctocog alfa pegol, 200 IU/ml after reconstitution.
Maltese: IU rurioctocog alfa pegol, 200 IU/mL wara r-rikostituzzjoni.
English: Connect the syringe to the BAXJECT II Hi-Flow.
Maltese: Qabbad is-siringa mal-apparat BAXJECT II Hi-Flow.
English: The medicinal product contains traces of mouse and hamster proteins.
Maltese: Il-prodott mediċinali fih traċċi ta' proteini tal-ġurdien u tal-ħamster.
English: Subjects received either prophylactic treatment (n = 120) with ADYNOVI at a dose of 40-50 IU per kg twice weekly or on-demand treatment (n = 17) with ADYNOVI at a dose of 10-60 IU per kg for a 6-month period.
Maltese: Individwi li rċevew jew kura profilattika (n=120) b'ADYNOVI b'doża ta' 40-50 IU għal kull kg darbtejn f'ġimgħa jew kura skont il-bżonn (n=17) b'ADYNOVI b'doża ta' 10-60
English: Do not use ADYNOVI: - if you are allergic to rurioctocog alfa pegol, octocog alfa or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to mouse or hamster proteins
Maltese: Tużax ADYNOVI: - jekk inti allerġiku għal rurioctocog alfa pegol, octocog alfa jew għal xi sustanza oħra ta' din il mediċina (imniżżla fis-sezzjoni 6). - jekk int allerġiku/a għal proteini tal-ġurdien jew tal-ħamster
English: 1 vial: 250 IU rurioctocog alfa pegol, 125 IU/ml after reconstitution.
Maltese: IU rurioctocog alfa pegol, 125
English: ADYNOVI 500 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Maltese: IU / 5 mL trab għall-injezzjoni rurioctocog alfa pegol
English: BLISTER LABEL (BAXJECT III SYSTEM)
Maltese: TIKKETTA FUQ IL-FOLJA (SISTEMA BAXJECT III)
English: 1 powder vial and 1 vial with 5 ml solvent preassembled in BAXJECT III system.
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni 1 kunjett bit-trab u 1 kunjett b'solvent ta' 5 mL immuntat minn qabel f'sistema BAXJECT III.
English: - ADYNOVI in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister, withthe powder vial and the solvent vial preassembled for reconstitution.
Maltese: - ADYNOVI f'sistema BAXJECT III: Kull pakkett fih sistema BAXJECT III lesta għall-użu f'folja ssiġillata, bil-kunjett tat-trab u l-kunjett tas-solvent mmuntati minn qabel għarrikostituzzjoni.
English: Each pack contains one powder vial, one solvent vial and a device for reconstitution (BAXJECT II Hi-Flow).
Maltese: Kull pakkett fih kunjett wieħed bit-trab, kunjett wieħed bis-solvent u apparat għar-rikostituzzjoni (BAXJECT II Hi-Flow).
English: Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Maltese: Il-fattur VIII attivat jaġixxi bħala kofattur għall-fattur IX attivat, u jaċċellera l-bidla tal-fattur X għal fattur X attivat.
English: 1 vial: 500 IU rurioctocog alfa pegol, 250 IU/ml after reconstitution.
Maltese: IU rurioctocog alfa pegol, 250
English: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature not above 30° C. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Maltese: Mil-lat mikrobijoloġiku, il-prodott għandu jintuża immedjatament, ħlief jekk il-metodu ta' rikostituzzjoni jipperkludi r-riskju ta' kontaminazzjoni mikrobjali.
English: ADYNOVI 250 IU / 2 ml powder for injection rurioctocog alfa pegol IV
Maltese: IU / 2 mL trab għall-injezzjoni rurioctocog alfa pegol
English: VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT GĦAS-SOLVENT (SISTEMA BAXJECT III)
English: Connect the syringe to the BAXJECT III device.
Maltese: Qabbad is-siringa mal-apparat BAXJECT III.
English: • Do not use after the expiry date stated on the labels and carton.
Maltese: • Tużax wara d-data tal-iskadenza li tidher fuq it-tikketta u l-kartuna.
English: The median dosing interval was 3.6 days and the mean dose (SD) was 48.7 (4.4) IU/kg.
Maltese: L-intervall ta' dożaġġ medjan kien 3.6 jiem u d-doża medja (SD) kienet 48.7 (4
English: You should be aware of the early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness.
Maltese: Hemm riskju rari li jaf tesperjenza reazzjoni anafilattika (reazzjoni allerġika severa u f'daqqa) għal ADYNOVI. Għandek tkun konxju ta' sinjali bikrija ta' reazzjonijiet allerġiċi bħal raxx, ħorriqija, wheals, ħakk ġeneralizzat, nefħa tax-xufftejn u l-ilsien, diffikultà biex tieħu n-nifs, tħarħir, tagħfis fissider, sensazzjoni ġenerali li ma tħossokx tajjeb, u sturdament.
English: ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 400 IU/ml after reconstitution with 5 ml solvent.
Maltese: IU ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), rurioctocog alfa pegol, li jikkorrispondu għal konċentrazzjoni ta' 400 IU/mL wara r-rikostituzzjoni b'5 mL ta' solvent.
English: ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Maltese: IU / 5 mL trab u solvent għal soluzzjoni għall-injezzjoni rurioctocog alfa pegol
English: The change in PK parameters was similar in both the adult and adolescent populations and between one-stage clotting and chromogenic substrate assays.
Maltese: Il-bidla fil-parametri PK kienet simili kemm fil-popolazzjonijiet tal-adulti kif ukoll f'dik tal-adolexxenti u bejn l-assaġġi ta' koagulazzjoni ta' stadju wieħed u dawk tas-substrat kromoġeniku.
English: ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol
Maltese: IU / 2 mL trab u solvent għal soluzzjoni għall-injezzjoni rurioctocog alfa pegol
English: Remove the BAXJECT III system from the blister.
Maltese: Neħħi is-sistema BAXJECT III mill-folja.
English: Haemophila A occurs only rarely in women.
Maltese: Emofilja A isseħħ biss rarament fin-nisa.
English: Powder: White to off-white friable powder.
Maltese: Tagħmlux fil-friġġ.
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 125 IU/ml after reconstitution with 2 ml solvent.
Maltese: IU ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), rurioctocog alfa pegol, li jikkorrispondu għal konċentrazzjoni ta' 125 IU/mL wara r-rikostituzzjoni b'2 mL ta' solvent.
English: The prophylactic regimen was 40 to 60 IU/kg of ADYNOVI twice a week.
Maltese: L-iskema profilattika kienet 40 sa 60
English: The median annualised bleed rate (ABR) in the on-demand treatment arm was 41.5 compared to 1.9 while on a twice a week prophylaxis regimen.
Maltese: Ir-rata ta' fsada annwali (ABR) medjana fil-fergħa ta' kura skont il-bżonn kienet 41.5 mqabbla ma' 1.9 waqt fuq kors ta' profilassi darbtejn fil-ġimgħa.
English: Octocog alfa is then covalently conjugated with the PEG reagent.
Maltese: Octocog alfa hija mbagħad ikkonjugata b'mod kovalenti mar-reaġent PEG.
English: ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Maltese: IU / 5 mL trab u solvent għal soluzzjoni għall-injezzjoni rurioctocog alfa pegol (Fattur VIII pegilat tal-koagulazzjoni tal-bniedem rikombinanti)
English: The observed event of hypersensitivity was a mild transient non-serious rash, occurring in one 2-year-old patient who had developed a previous rash while on ADYNOVI.
Maltese: L-avveniment osservat ta' sensittività eċċessiva kien raxx ħafif temporanju mhux serju, li seħħ f'pazjent wieħed ta' sentejn li kien żviluppa raxx preċedenti meta kien qed jieħu ADYNOVI.
English: ADYNOVI Paediatric patients (< 6 years) N = 14 Dose: 50 ± 10 IU/kg
Maltese: ADYNOVI Pazjenti pedjatriċi (< 6 snin) N=14
English: ADYNOVI in BAXJECT III system: Keep the sealed blister in the outer carton in order to protect from light.
Maltese: ADYNOVI f'sistema BAXJECT III: Żomm il-folja ssiġillata fil-kartuna ta' barra sabiex tilqa' middawl.
English: ADYNOVI with BAXJECT II Hi-Flow device: Keep the vial in the outer carton in order to protect from light.
Maltese: ADYNOVI b'apparat BAXJECT II HI-FLOW: Żomm il-kunjett fil-kartuna ta' barra sabiex tilqa' middawl.
English: How to store ADYNOVI
Maltese: Jekk tinsa tuża ADYNOVI
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for factor VIII in plasma).
Maltese: L-attività ta' fattur VIII fil-plażma hi espressa jew bħala perċentwali (b'relazzjoni mal-plażma normali tal-bniedem) jew preferibbilment f'Unitajiet Internazzjonali (b'relazzjoni mal-Istandard Internazzjonali għal fattur VIII fil-plażma).
English: Remove the blue cap from the BAXJECT III device.
Maltese: Neħħi t-tapp il-blu mill-apparat BAXJECT III.
English: Remove plastic caps from the powder and solvent vials.
Maltese: Neħħi t-tappijiet tal-plastik mill-kunjetti tat-trab u s-solvent.
English: For long term prophylaxis, the recommended dose is 40 to 50 IU of ADYNOVI per kg bodyweight twice weekly in 3 to 4 day intervals.
Maltese: IU ta' ADYNOVI għal kull kg tal-piż talġisem darbtejn fil-ġimgħa f'intervalli ta' 3 sa 4 ijiem.
English: ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 250 IU/ml after reconstitution with 2 ml solvent.
Maltese: IU ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), rurioctocog alfa pegol, li jikkorrispondu għal konċentrazzjoni ta' 250 IU/mL wara r-rikostituzzjoni b'2 mL ta' solvent.
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Maltese: IU / 2 mL trab u solvent għal soluzzjoni għall-injezzjoni Rurioctocog alfa pegol (fattur VIII pegilat tal-koagulazzjoni tal-bniedem rikombinanti)
English: If you suffer from cardiac disease, please inform your doctor, as there is an increased risk of blood clotting (coagulation) complications.
Maltese: Jekk issofri minn mard tal-qalb, jekk jogħġbok informa lit-tabib tiegħek, peress li hemm riskju akbar ta' kumplikazzjonijiet ta' tagħqid tad-demm (koagulazzjoni).
English: More extensive haemarthrosis, muscle bleeding or haematoma
Maltese: Emartrosi aktar estensiva, fsada fil-muskoli jew ematoma.
English: Individual PK with 12 post-infusion samples.
Maltese: PK individwali bi 12-il kampjun ta' wara l-infużjoni.
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Maltese: IU / 5 mL trab u solvent għal soluzzjoni għall-injezzjoni rurioctocog alfa pegol (fattur VIII pegilat tal-koagulazzjoni tal-bniedem rikombinanti)
English: Twenty-five of the 137 subjects were adolescents (12 to less than 18 years of age).
Maltese: Ħamsa u għoxrin minn 137 individwu kienu adolexxenti (12 sa inqas minn 18-il sena).
English: Perioperative haemostatic efficacy was rated as excellent (blood loss less than or equal to that expected for the same type of procedure performed in a non-haemophilic patient, and required blood components for transfusions less than or similar to that expected in non-haemophilic population) for all 26 (21 major, 5 minor) procedures.
Maltese: L-effikaċja emostatika perioperatorja kienet ikklassifikata bħala eċċellenti (telf tad-demm inqas minn jew ugwali għal dak mistenni għall-istess tip ta' proċedura mwettqa f'pazjent li m'għandux l-emofilja, u komponenti tad-demm meħtieġa għat-trasfużjonijiet inqas minn jew simili għal dawk mistennija f'popolazzjoni mingħajr l-emofilja) għas-26 proċedura (21 maġġuri, 5 minuri) kollha kemm huma.
English: Remove the blue cap from the BAXJECT II Hi-Flow device (Figure E).
Maltese: Hi-Flow (Figura E).
English: Further information on Lenalidomide Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Lenalidomide Accord tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Lenalidomide Accord, lenalidomide, is an immunomodulating agent.
Maltese: Is-sustanza attiva f'Lenalidomide Accord, lenalidomide, hija aġent immunomodulanti.
English: Lenalidomide Accord is used:
Maltese: Lenalidomide Accord jintuża:
English: Lenalidomide Accord contains the active substance lenalidomide and is a ‘generic medicine'.
Maltese: Lenalidomide Accord fih is-sustanza attiva lenalidomide u huwa "mediċina ġenerika".
English: • in combination with melphalan (a cancer medicine) and prednisone (an anti-inflammatory medicine) for the treatment of adults with previously untreated multiple myeloma, who cannot have a stem cell transplant;
Maltese: • flimkien ma' melphalan (mediċina tal-kanċer) u prednisone (mediċina antiinfjammatorja) fil-kura ta' adulti b'majeloma multipla li ma kinitx ġiet ikkurata qabel, li ma jistax ikollhom trapjant taċċelloli staminali;
English: Lenalidomide works in a number of different ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within tumours and also stimulates specialised cells of the immune system to attack the abnormal cells.
Maltese: Lenalidomide taħdem f'numru ta' diversi modi: timblokka l-iżvilupp ta' ċelloli anormali, tipprevjeni li l-vażi jikbru f'tumuri u tistimula wkoll xi ċelloli speċjalizzati tas-sistema immuni biex jattakkaw iċ-ċelloli anormali.
English: Lenalidomide Accord is taken in repeated 28-day cycles: the patient takes the medicine once a day on certain days over 28 days.
Maltese: Lenalidomide Accord jittieħed ripetutament f'ċikli ta' 28 jum: il-pazjent jieħu l-mediċina darba kuljum f'ċerti jiem fuq medda ta' 28 jum.
English: Other information about Lenalidomide Accord
Maltese: Informazzjoni oħra dwar Lenalidomide Accord
English: How is Lenalidomide Accord used?
Maltese: Lenalidomide Accord?
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Revlimid, and do not need to be repeated for Lenalidomide Accord.
Maltese: Studji fuq il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat diġà twettqu bil-mediċina ta' referenza, Revlimid, u m'għandhomx għalfejn jiġu ripetuti għal Lenalidomide Accord.
English: Because Lenalidomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Lenalidomide Accord huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The company that markets Lenalidomide Accord will provide a letter and educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely.
Maltese: Il-kumpanija li tqiegħed Lenalidomide Accord fis-suq ser tipprovdi ittra u pakketti edukattivi għallprofessjonisti fil-qasam tal-kura tas-saħħa, u fuljetti għall-pazjenti, li jispjegaw li l-mediċina tista' tkun ta' ħsara għat-tarbija fil-ġuf u jagħtu dettalji dwar il-passi li jridu jittieħdu biex il-mediċina tintuża b'mod sigur.
English: • in combination with dexamethasone (an anti-inflammatory medicine), for the treatment of adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have a stem cell transplant;
Maltese: • flimkien ma' dexamethasone (mediċina antiinfjammatorja), fil-kura ta' adulti b'majeloma multipla (dijanjostikata riċentement) li ma kinitx ġiet ikkurata qabel, li ma jistax ikollhom trapjant taċ-ċelloli staminali;
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Ilkumpanija wettqet ukoll studju li wera li huwa "bijoekwivalenti" għall-mediċina ta' referenza.
English: • in combination with dexamethasone, in adults whose disease has been treated at least once in the past.
Maltese: • flimkien ma' dexamethasone, f'adulti li l-marda tagħhom ġiet ikkurata minn tal-inqas darba filpassat.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Lenalidomide Accord has been shown to have comparable quality and to be bioequivalent to Revlimid.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Lenalidomide Accord wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Revlimid.
English: What are the benefits and risks of Lenalidomide Accord?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Lenalidomide Accord?
English: Lenalidomide Accord is a medicine used for the treatment of multiple myeloma, a cancer of a type of white blood cells called plasma cells.
Maltese: Informazzjoni dwar il-mediċina ta' referenza tinstab ukoll fis-sit elettroniku tal-Aġenzija.
English: Lenalidomide Accord is available as capsules of various strengths to be taken by mouth.
Maltese: Lenalidomide Accord jiġi bħala kapsuli ta' diversi qawwiet li jittieħdu mill-ħalq.
English: As for all medicines, data on the use of Lenalidomide Accord are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Lenalidomide Accord hija ssorveljata kontinwament.
English: Side effects reported with Lenalidomide Accord are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Lenalidomide Accord huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: This means that Lenalidomide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Revlimid.
Maltese: Dan ifisser li Lenalidomide Accord fih l-istess sustanza attiva u jaħdem bl-istess mod bħal "mediċina ta' referenza" diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Revlimid.
English: Therefore, the Agency's view was that, as for Revlimid, the benefit of Lenalidomide Accord outweighs the identified risk and it can be authorised for use in the EU.
Maltese: Għaldaqstant, lopinjoni tal-Aġenzija kienet li, bħal fil-każ ta' Revlimid, il-benefiċċju ta' Lenalidomide Accord huwa akbar mir-riskju identifikat u jista' jiġi awtorizzat għall-użu fl-UE.
English: This means that it affects the activity of the immune system (the body's natural defences).
Maltese: Dan ifisser li taffettwa l-attività tas-sistema immuni (id-difiżi naturali tal-ġisem).
English: The dose depends on the situation in which Lenalidomide Accord is used.
Maltese: Id-doża tiddependi mis-sitwazzjoni li fiha jintuża Lenalidomide Accord.
English: How has Lenalidomide Accord been studied?
Maltese: Kif ġie studjat Lenalidomide Accord?
English: The dose should be reduced or treatment interrupted depending on whether the disease has worsened, the severity of any side effects and the levels of platelets (components that help the blood to clot) and neutrophils (a type of white blood cell that helps fight infection).
Maltese: Id-doża għandha titnaqqas jew il-kura għandha tiġi interrotta skont jekk il-marda tkunx qalbet għall-agħar, is-severità ta' kwalunkwe effett sekondarju u l-livelli ta' pjastrini (komponenti li jgħinu biex id-demm jagħqad) u ta' newtrofili (tip ta' ċelloli bojod tad-demm li jgħinu jiġġieldu l-infezzjoni).
English: 17813 Vall de Bianya
Maltese: 17813 Vall de Bianya Girona
English: Date of latest renewal: 13/12/2016
Maltese: Data tal-aħħar tiġdid: 13/12/2016