FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Pramipexole Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Mirapexin.
Maltese: Peress li Pramipexole Accord huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza Mirapexin.
English: The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated.
Maltese: Id-doża għandha tiġi miżjuda kull ħames sa sebat ijiem sakemm is-sintomi jiġu kkontrollati mingħajr ma jiġu kkawżati effetti sekondarji li ma jistgħux jiġu tollerati.
English: What is Pramipexole Accord?
Maltese: Kif jintuża Pramipexole Accord?
English: Therefore, the CHMP's view was that, as for Mirapexin, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Mirapexin, il-benefiċċji huma akbar mir-riskji identifikati.
English: Pramipexole Accord can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective.
Maltese: Pramipexole Accord jista' jintuża jew waħdu jew flimkien mal-levodopa (mediċina oħra kontra l-marda ta' Parkinson) f'kull stadju tal-marda, anke fl-aħħar stadji meta l-levodopa tibda ssir inqas effikaċi;
English: Why has Pramipexole Accord been approved?
Maltese: Għaliex ġie approvat Pramipexole Accord?
English: Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as shaking, stiffness and slowness of movement.
Maltese: Il-pramipexole tistimola l-moħħ bħalma tagħmel id-dopamina, biex b'hekk il-pazjenti jkunu jistgħu jikkontrollaw il-movimenti tagħhom u jkollhom inqas sinjali u sintomi tal-marda ta' Parkinson, bħar-rogħda, l-ebusija u d-dewmien filmovimenti.
English: 1 bottle
Maltese: 7 pilloli
English: 15 ml
Maltese: 20 mg/ml
English: 20 mg/ml Oral drops, solution
Maltese: Għall-użu orali flixkun (ħġieġ) 15 ml flixkun 1
English: Oral use bottle (glass)
Maltese: Qtar orali, soluzzjoni
English: Leptospira vaccine
Maltese: Il-vaċċin Lettospira
English: This summary was last updated on 16 July 2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 16/07/2012.
English: Leptospirosis disease in dogs results in bleeding, hepatitis (infection of the liver) and jaundice (yellowing of the skin and eyes) or nephritis (kidney infection).
Maltese: Il-marda Lettospirosi fil-klieb tirriżulta fi fsad, epatite (infezzjoni tal-fwied) u suffejra (sfura fil-ġilda u fl-għajnejn) jew nefritis (infezzjoni fil-kliewi).
English: When puppies are known to have high levels of maternally derived antibodies (special type of proteins, received from the mother in the milk, that help the body to fight infection), it is recommended that the first vaccination is given at
Maltese: Meta lfrieħ ikun magħruf li jkollhom livelli għoljin ta' antikorpi ta' oriġini materna (tip speċjali ta' proteini, li jkunu ħadu mill-ħalib ta' ommhom, li jgħinu l-ġisem jiġġieled l-infezzjoni), huwa rakkomandat li l
English: What is Nobivac L4?
Maltese: X'inhu Novibac L4?
English: Why has Nobivac L4 been approved?
Maltese: Għaliex ġie approvat Nobivac L4 ?
English: Nobivac L4 is a vaccine.
Maltese: Novibac L4 huwa vaċċin.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobivac L4 on 16 July 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha lil Nobivac L4 fil-16/07/2012.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac L4 exceed the risks and recommended that it be given a marketing authorisation.
Maltese: Il-Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) kkonkluda li l-benefiċċji ta' Nobivac L4 jisbqu r-riskji tiegħu u għaldaqstant irrakkomanda jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: A mild and temporary increase in body temperature ( 1°C) may occur for a few days after vaccination, with some puppies showing less activity and/or a reduced appetite.
Maltese: Jista' jkun hemm żieda ħafifa u temporanja fit-temperatura tal-ġisem ( 1°C) għal ftit jiem wara lvaċċin, b'xi wħud mill-frieħ li juru anqas attività u/jew nuqqas fl-aptit.
English: The vaccine also reduces the excretion (shedding) of the virus into the urine by the infected dogs, thereby reducing the risk of transmission.
Maltese: Il-vaċċin inaqqas ukoll leskrezzjoni (tixrid) tal-vajrus fl-awrina mill-klieb infettati u b'hekk ikun qed inaqqas ir-riskju ta' trażmissjoni.
English: The benefit/risk balance can be found in the scientific discussion module of this EPAR.
Maltese: Ilbilanċ bejn il-benefiċċju u r-riskju jinsab fil-modulu tad-diskussjoni xjentifika ta' dan l-EPAR.
English: Nobivac L4 is used to vaccinate dogs from six weeks of age to reduce the risk of developing an infection with certain Leptospira strains.
Maltese: Dan id-dokument ma jistax jieħu post diskussjoni wiċċ imb wiċċ mal-veterinarju tiegħek.
English: Nobivac L4 is a vaccine available as a suspension for injection.
Maltese: Nobivac L4 huwa vaċċin li jiġi bħala sospensjoni għall-injezzjoni.
English: Other information about Nobivac L4:
Maltese: Tagħrif ieħor dwar Novibac L4:
English: EU/1/09/601/001 Firdapse
Maltese: EU/1/09/601/001
English: 10 mg tablet
Maltese: 10 mg Pillola
English: Perforated unit dose thermoformed blisters
Maltese: Folji perforati ta' dożi uniċi, iffurmati bissħana
English: (invented) name Strength Pharmaceutical form
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: MA (EU)-number
Maltese: Numru ta' l-EU
English: Packsize
Maltese: Firdapse
English: g n d
Maltese: l t o r
English: Zarzio contains sorbitol (E420).
Maltese: Zarzio fih sorbitol (E420).
English: Zarzio contains sorbitol
Maltese: Zarzio fih sorbitol
English: Zarzio can be used:
Maltese: Zarzio jista' jintuża:
English: Zarzio is a biosimilar medicinal product.
Maltese: Zarzio huwa prodott mediċinali bijoloġiku simili.
English: Relative Risk (95% CI) of GvHD and TRM Following treatment with G-CSF after bone marrow transplantation Publication
Maltese: Riskju Relattiv (95% CI) ta' GvHD u TRM Wara l-kura b'G-CSF wara trapjant tal-mudullun
English: Permanently discontinue Zarzio in patients with clinically significant hypersensitivity.
Maltese: Waqqaf b'mod permanenti Zarzio f'pazjenti b'sensittività eċċessiva klinikament sinifikanti.
English: If required, Zarzio may be diluted in glucose 50 mg/ml (5%) solution.
Maltese: Jekk ikun meħtieġ, Zarzio jista' jiġi dilwit f'soluzzjoni ta' 50 mg/ml (5%) ta' glucose.
English: Zarzio is not recommended during pregnancy.
Maltese: Zarzio ma fih ebda preservattiv.
English: Musculoskeletal painc
Maltese: Uġigħ muskolo skeletrikuċ
English: Zarzio must not be diluted with sodium chloride solution.
Maltese: Zarzio m'għandux jiġi dilwit b'soluzzjonijiet ta' sodium chloride.
English: Blood glucose decreased Pseudogouta (Chondrocalcinosis Pyrophosphate) Fluid volume disturbances
Maltese: Tnaqqis ta' glucose fid-demm Psewdogottaa (Pirofosfat kondrokalikinosi) Disturbi fil-volum tal-fluwidi
English: Uncommon (≥ 1/1,000 to
Maltese: (≥1/1,000 sa
English: The most serious adverse reactions that may occur during filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia and ARDS), capillary leak syndrome, severe splenomegaly/splenic rupture, transformation to myelodysplastic syndrome or leukaemia in SCN patients, GvHD in patients receiving allogeneic bone marrow transfer or peripheral blood cell progenitor cell transplant and sickle cell crisis in patients with sickle cell disease.
Maltese: L-iktar reazzjonijiet avversi serji li jistgħu jseħħu waqt kura b'Filgrastim jinkludu: reazzjoni anafilattika, avvenimenti avversi pulmonari serji (inklużi pnewmonja interstizjali u ARDS), sindromu ta' tnixxija tal-kapillari, splenomegalija/qsim tal-milsa severi, trasformazzjoni għal sindrome majelodisplastiku jew lewkemija f'pazjenti b'SCN, GvHD f'pazjenti li qed jirċievu trasferiment talmudullun alloġeniku jew trapjant taċ-ċelluli proġenituri taċ-ċelluli tad-demm periferali u kriżijiet taċċelluli sickle f'pazjenti bil-marda taċ-ċelluli sickle.
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution given over 30 minutes (see section 6.6).
Maltese: Filgrastim jista' jingħata bħala injezzjoni ta' kuljum taħt il-ġilda jew bħala infużjoni ta' kuljum ġol-vini dilwita f'5% ta' soluzzjoni tal-glucose mogħtija fuq perjodu ta' 30 minuta (ara sezzjoni 6.6).
English: In view of the possible risk of microbial contamination, Zarzio syringes are for single use only.
Maltese: Minħabba r-riskju possibbli ta' kontaminazzjoni mikrobjali, is-siringi b'Zarzio jintużaw darba biss.
English: - Treatment of persistent neutropenia (ANC ≤ 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Maltese: - Il-kura ta' newtropenja persistenti (ANC ≤ 1.0 x 109/l) f'pazjenti b'infezzjoni avvanzata tal-HIV, sabiex jitnaqqas ir-riskju ta' infezzjonijiet batterjali meta għażliet oħrajn għall-immaniġġjar tan-newtropenja ma jkunux adattati.
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 48 MU filgrastim in 0.5 ml, corresponding to 96 MU/ml - The other ingredients are glutamic acid, sorbitol (E420), polysorbate 80 and water for injections.
Maltese: Kull siringa mimlija għal-lest fiha 48 MU ta' filgrastim f'0.5 ml li jikkorrispondi għal 96 MU/ml. - Is-sustanzi mhux attivi l-oħra huma glutamic acid, sorbitol (E420), polysorbate 80 u ilma għall-injezzjonijiet.
English: Randomised, double-blind, single and multiple dose, crossover studies in 204 healthy volunteers showed that the pharmacokinetic profile of Zarzio was comparable to that of the reference product after subcutaneous and intravenous administration.
Maltese: .2 Tagħrif farmakokinetiku Studji crossover, randomised, double-blind, dwar dożi waħidhom u dożi multipli li saru fuq 204 voluntiera b'saħħithom, urew li l-profil farmakokinetiku ta' Zarzio kien komparabbli ma' dak tal-prodott tar-referenza wara l-għoti taħt il-ġilda u l-għoti ġol-vini.
English: added.
Maltese: Pubblikazzjoni
English: Chest paina Paina
Maltese: U MNEJN GĦANDU JINGĦATA
English: Do not administer Zarzio to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Maltese: Tagħtix Zarzio lil pazjenti bi storja medika ta' sensittività eċċessiva għal filgrastim jew pegfilgrastim.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Each ml of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) filgrastim*.
Maltese: Kull ml ta' soluzzjoni fih 96 miljun unità (MU) (ekwivalenti għal 960 mikrogramma [μg]) ta' filgrastim*.
English: The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Maltese: Is-sigurtà u l-effikaċja ta' filgrastim ma kinux evalwati f'donaturi normali ta' < 16-il sena jew ta'
English: Pulmonary adverse effects
Maltese: Emorraġija pulmonari
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) filgrastim*.
Maltese: MU/0.5 ml soluzzjoni għall-injezzjoni jew infużjoni f'siringa mimlija għal-lest Kull ml ta' soluzzjoni fih 60 miljun unità (MU) (ekwivalenti għal 600 mikrogramma [μg]) ta'
English: Zarzio is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Maltese: Zarzio normalment jingħata bħala injezzjoni ta' kuljum fit-tessut li jkun immedjatment taħt il-ġilda (magħrufa bħala injezzjoni taħt il-ġilda).
English: Zarzio containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Maltese: Zarzio li fih r-metHuG-CSF (filgrastim) jikkawża żidiet notevoli fl-għadd tan-newtrofili tad-demm periferali fi żmien 24 siegħa, b'żidiet żgħar fil-monoċiti.
English: Zarzio is available in packs containing 1, 3, 5 or 10 pre-filled syringes with injection needle and with or without a needle safety guard.
Maltese: Zarzio hu disponibbli f'pakketti li fihom 1, 3, 5 jew 10 siringi mimlija għal-lest b'labra tal-injezzjoni bi jew mingħajr protezzjoni tas-sigurtà tal-labra.
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
Maltese: Zarzio 30 MU/0.5 ml soluzzjoni għall-injezzjoni jew infużjoni f'siringa mimlija għal-lest Zarzio 48 MU/0.5 ml soluzzjoni għall-injezzjoni jew infużjoni f'siringa mimlija għal-lest
English: • abnormal x-rays of the lungs (lung infiltration)
Maltese: • infjammazzjoni tal-pulmun (mard interstizjali tal-pulmun) • x-rays anormali tal-pulmun (infiltrazzjoni tal-pulmun)
English: Zarzio 48 MU/0.5 ml injection or infusion Filgrastim
Maltese: Zarzio 48 MU/0.5 ml injezzjoni jew infużjoni
English: EU/1/08/495/005 EU/1/08/495/006 EU/1/08/495/007 EU/1/08/495/008
Maltese: EU/1/08/495/006 EU/1/08/495/007 EU/1/08/495/008
English: Splenic rupturea Sickle cell anaemia with crisis
Maltese: Anemija taċċelluli sickle bi kriżijiet
English: Other medicines and Zarzio
Maltese: X'fih Zarzio
English: Zarzio 30 MU/0.5 ml injection or infusion Filgrastim
Maltese: Zarzio 30 MU/0.5 ml injezzjoni jew infużjoni
English: The observed adverse effect level for embryo-foetal toxicity in this study was 10 µg/kg/day, which corresponded to a systemic exposure of approximately 3 - 5 times the exposures observed in patients treated with the clinical dose.
Maltese: Il-livell ta' effett avvers osservat għal tossiċità embrijofetali f''dan l-istudju kienet ta' 10 µg/kg/kuljum, li jikkorrispondi għal esponiment sistemiku ta' madwar 3 - 5 darbiet tal-esponimenti osservati f'pazjenti kkurati bid-doża klinika.
English: Zarzio is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of proteins called cytokines.
Maltese: Zarzio hu fattur tat-tkabbir taċ-ċelluli tad-demm bojod (fattur li jistimula kolonji ta' granuloċiti) u jappartjeni għal grupp ta' proteini msejħa cytokines.
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Zarzio.
Maltese: L-espożizzjoni aċċidentali għal temperaturi taħt iż-żero mhux ser taffettwa b'mod negattiv l-istabbiltà ta' Zarzio.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva/i
English: Rasha Erythema
Maltese: Użu ġerjatriku
English: EU/1/08/495/013 EU/1/08/495/014 EU/1/08/495/015 EU/1/08/495/016
Maltese: EU/1/08/495/013 EU/1/08/495/014
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 30 MU filgrastim in 0.5 ml, corresponding to 60 MU/ml.
Maltese: Zarzio 30 MU/0.5 ml soluzzjoni għall-injezzjoni jew infużjoni f'siringa mimlija għal-lest:
English: During intermittent dosing with 30 MU/day (300 μg/day) of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Maltese: Matul id-dożaġġ intermittenti bi 30 MU/kuljum (300 μg/kuljum) ta' filgrastim, jista' jkun hemm fluttwazzjonijiet kbar fl-ANC tal-pazjent mal-medda taż-żmien.
English: Fatiguea Mucosal inflammationa Pyrexia
Maltese: Reazzjoni fis-sit tal-injezzjoni
English: How to store Zarzio
Maltese: U KWANTITATTIVA Zarzio 30
English: If the ANC decreases to < 1.0 x 109/l during the treatment period, the dose of filgrastim should be re-escalated according to the above steps ANC = absolute neutrophil count
Maltese: Waqqaf filgrastim Jekk l-ANC jonqos għal < 1.0 x 109/l matul il-perjodu tal-kura, id-doża ta' filgrastim għandha tiżdied mill-ġdid skont il-passi t'hawn fuq ANC = għadd assolut ta' newtrofili
English: Muscle spasms Osteoporosis
Maltese: Disturbi muskolu skeletriċi u tat-tessuti konnettivi
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Maltese: Zarzio 48 MU/0.5 ml soluzzjoni għall-injezzjoni jew infużjoni f'siringa mimlija għal-lest
English: Filgrastim may be given as a 30 minute or 24 hour intravenous infusion or given by continuous 24 hour subcutaneous infusion.
Maltese: Filgrastim jingħata bħala infużjoni qasira ġol-vini fuq perjodu ta' 30 minuta jew bħala infużjoni kontinwa taħt il-ġilda jew ġol-vini fuq perjodu ta' 24 siegħa.
English: Each pre-filled syringe contains 30 MU (equivalent to 300 μg) filgrastim in 0.5 ml.
Maltese: Kull siringa mimlija għal-lest fiha 30 MU (ekwivalenti għal 300 μg) ta' filgrastim f'0.5 ml.
English: For maintaining normal neutrophil counts
Maltese: Għall-manteniment tal-għadd normali tan-newtrofili:
English: EU/1/08/495/009 EU/1/08/495/010 EU/1/08/495/011 EU/1/08/495/012
Maltese: EU/1/08/495/006 EU/1/08/495/007 EU/1/08/495/008 EU/1/08/495/013 EU/1/08/495/014
English: - have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be signs of a severe allergic reaction (hypersensitivity).
Maltese: - ikollok sinjali għal għarrieda ta' allerġija bħal raxx, ħakk jew ħorriqija fuq il-ġilda, nefħa tal-wiċċ, xufftejn, ilsien jew partijiet oħrajn tal-ġisem, qtugħ ta' nifs, tħarħir jew problemi biex tieħu n-nifs, għax dawn jistgħu jkunu sinjali ta' reazzjoni allerġija severa (sensittività eċċessiva). - ikollok nefħa f'wiċċek jew fl-għekiesi, demm fl-awrina tiegħek jew awrina ta' lewn kannella jew tinnota li tgħaddi awrina inqas mis-soltu (glomerulonefrite).
English: The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Maltese: • biex iżid in-numru ta' ċelluli tad-demm bojod wara trapjant tal-mudullun biex jgħin fil-prevenzjoni tal-infezzjonijiet;
English: The long-term safety of filgrastim administration above 24 μg/kg/day in patients with SCN has not been established.
Maltese: Is-sigurtà fit-tul tal-għoti ta' filgrastim f'iktar minn 24 μg/kg/kuljum f'pazjenti b'SCN ma kinitx stabbilita.
English: The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MU/kg/day (10 μg/kg/day) for 5 - 7 consecutive days.
Maltese: Id-doża tal-bidu rakkomandata ta' filgrastim hi ta' 0.1 MU/kg/kuljum (1 μg/kg/kuljum), b'titrazzjoni sa massimu ta' 0.4
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medications or undergoing apheresis (see section 4.4).
Maltese: Dawn ġeneralment seħħew f'pazjenti b'mard malinn avvanzat, sepsis, li jieħdu mediċini multipli tal-kimoterapija jew li għaddejjin minn aferesi (ara sezzjoni 4.4).
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Maltese: Zarzio 30 MU/0.5 ml soluzzjoni għall-injezzjoni jew infużjoni f'siringa mimlija għal-lest
English: 84 capsules
Maltese: 84 kapsula
English: 84 x 1 capsules (unit dose)
Maltese: 84x1 kapsula (doża unitarja)
English: EMA procedure number
Maltese: Numru talproċedura ta' lEMA
English: 21 September 2018 EMA/621972/2018 EMEA/H/C/004355
Maltese: 21 ta' Settembru 2018 EMA/621972/2018 EMEA/H/C/004355
English: What is Exondys?
Maltese: X'inhu Exondys?
English: Refusal of the marketing authorisation for Exondys (eteplirsen) EMA/621972/2018
Maltese: Rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq ta' Exondys (eteplirsen) EMA/621972/2018
English: The company that applied for authorisation, AVI Biopharma International Ltd, requested a re-examination of the CHMP's opinion on 1 June 2018.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni, AVI Biopharma International Ltd, talbet li terġa' tiġi eżaminata l-opinjoni talCHMP fl-1 ta' Ġunju 2018.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom mistennija li taġixxi b'mod simili għad-distrofin normali, u tgħin lill-ġisem biex jirrimedja għan-nuqqas ta' distrofin, u b'hekk ittaffi s-sintomi ta' DMD.
English: Exondys is a medicine that contains the active substance eteplirsen.
Maltese: Exondys huwa mediċina li fih is-sustanza attiva eteplirsen.
English: What was Exondys expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Exondys?
English: Exondys was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 3 December 2008 for the treatment of DMD.
Maltese: Exondys kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit3 ta' Diċembru 2008, għall-kura ta' DMD.
English: It was to be available as a concentrate for solution for infusion (drip) into a vein.
Maltese: Kellu jkun disponibbli bħala konċentrat għal soluzzjoni għall-infużjoni (dripp) ġo vina.
English: Patients with DMD do not produce a protein called dystrophin.
Maltese: Pazjenti b'DMD ma jipproduċux proteina msejħa distrofin.
English: Exondys was expected to be used for treating Duchenne muscular dystrophy (DMD) in patients aged from 4 years with mutation (change) in the DMD gene that allows treatment involving ‘exon 51 skipping'.
Maltese: Exondys kien mistenni li jintuża għall-kura tad-distrofija muskolari Duchenne (DMD) f'pazjenti minn 4 snin ‘il fuq b'mutazzjoni (bidla) fil-ġene DMD li tippermetti kura li tinvolvi ‘qbiż ta' exon 51'.
English: On 31 May 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Exondys, intended for the treatment of Duchenne muscular dystrophy.
Maltese: Fil-31 ta' Mejju 2018, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Exondys, maħsub għall-kura tad-distrofija muskolari Duchenne.
English: The company presented the results of two main studies involving 12 boys aged 7 to 13 years with DMD who had a genetic mutation amenable to exon 51 skipping.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' żewġ studji ewlenin li involvew 12-il tifel bejn is-7 u t-13-il sena b'DMD li kellhom mutazzjoni ġenetika suxxettibbli għal qbiż ta' exon 51.
English: The medicine allows exon 51 to be skipped over and so promote the production of a shortened form of dystrophin.
Maltese: Il-mediċina tippermetti li l-exon 51 tinqabeż u b'hekk tippromwovi l-produzzjoni ta' forma mnaqqsa ta' distrofin.
English: The CHMP was concerned that the main study, which involved just 12 patients, did not compare Exondys with placebo beyond 24 weeks, during which there was no meaningful difference between Exondys and placebo in the 6-minute walking distance.
Maltese: Il-CHMP kien imħasseb li l-istudju ewlieni, li involva biss 12-il pazjent, ma qabbilx Exondys ma' plaċebo wara l-24 ġimgħa, li matulhom ma kien hemm l-ebda differenza sinifikanti bejn Exondys u l-plaċebo fid-distanza ta' mixi ta' 6 minuti.