FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies and the post-marketing setting pulmonary adverse effects including interstitial lung disease, pulmonary oedema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see section
Maltese: Fi studji kliniċi u fl-ambjent ta' wara t-tqegħid fis-suq, effetti avversi pulmonari, fosthom mard talinterstizju tal-pulmun, edima pulmonari, u infiltrazzjoni fil-pulmun ġew irrappurtati fejn ftit minnhom irriżultaw f'falliment respiratorju jew f'sindrome ta' diffikultà respiratorja akuta (ARDS - acute respiratory distress syndrome), li jistgħu jkunu fatali (ara sezzjoni 4.4).
English: In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands or soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.
Maltese: sseħħ il-Marda tat-trapjant kontra l-ospitu (GvHD - Graft versus host disease) - din hija reazzjoni taċ ċelluli donaturi kontra l-pazjent li jirċievi t-trapjant; is-sinjali u s-sintomi jistgħu jinkludu raxx fuq ilpali ta' jdejk jew il-qiegħ ta' saqajk u ulċera u feriti f'ħalqek, fl-imsaren, fil-fwied, fil-ġilda, jew f'għajnejk, fil-pulmun, fil-vaġina u fil-ġogi.
English: Muscle spasms
Maltese: Spażmi tal muskoli
English: Store in a refrigerator.
Maltese: edima u emokonċentrazzjoni.
English: Solution for injection/infusion
Maltese: Soluzzjoni għall-injezzjoni/infużjoni
English: Hepatomeg aly
Maltese: taħt il-ġilda
English: MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
Maltese: MDS u lewkimja huma kumplikazzjonijiet naturali tal-marda u r-relazzjoni tagħhom ma' terapija b'filgrastim mhijiex ċerta.
English: The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Maltese: Minħabba varjazzjoni li hemm bejn pazjenti individwali u d-differenzi li hemm fl-analiżi ta' ċelluli CD34+ fil laboratorju, il-paragun dirett bejn studji varji huwa diffiċli.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: UŻU Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal- Karatteristiċi tal-Prodott, sezzjoni 4.2)
English: Rates of generation of antibodies against filgrastim is generally low.
Maltese: Ir-rata ta' ġenerazzjoni ta' antikorpi kontra filgrastim hija ġeneralment baxxa.
English: Transfusion reactione a See section c (Description of selected adverse reactions) b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or
Maltese: - jekk ikollok reazzjoni allerġika inkluż dgħufija, tnaqqis fil-pressjoni, diffikultà sabiex tieħu nifs, nefħa tal-wiċċ (anafilassi), raxx tal-ġilda, raxx bil-ħakk (urtikarja), nefħa tal-wiċċ, tax-xufftejn, tal-ħalq, tal-ilsien jew tal-gerżuma (anġjoedima) u qtugħ ta' nifs (dispnea). - jekk ikollok sogħla, deni jew diffikultà sabiex tieħu nifs (dispnea) minħabba li dan jista' jkun sinjal ta' Sindrome ta' Diffikultà Respiratorja Akuta (ARDS - Acute Respiratory Distress Syndrome). - jekk ikollok ħsara fil-kliewi (glomerulonefrite).
English: Splenic rupturea Sickle cell anaemia with crisisa
Maltese: • għadd baxx ta' ċelluli ħomor tad-demm (anemija)
English: Daily dosing with filgrastim should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Maltese: Erġa iċċekkja li hemm id-doża preskritta ta'Ratiograstim fis-siringa.
English: There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Maltese: L-effetti ta' doża eċċessiva ta' filgrastim ma ġewx stabbiliti.
English: The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MIU (5 μg)/kg/day from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Maltese: MIU (5 μg)/kg/jum mill-ewwel ġurnata wara t-tmiem tal-kimoterapija sakemm in-nadir mistenni jkun għadda u l-għadd ta' newtrofili jkun reġa' lura għan-normal.
English: Ratiograstim is a clear and colourless solution.
Maltese: Ratiograstim huwa soluzzjoni ċar u mingħajr kulur.
English: In clinical studies, dosing with 30 MIU (300 μg)/day on 1 to 7 days per week was required to maintain the ANC > 2.0 x 109/L, with the median dose frequency being 3 days per week.
Maltese: F'studji kliniċi, dożaġġ ta'30 MIU (300 μg)/jum għal ġurnata sa sebgħat ijiem fil-gimgħa kien meħtieġ biex jinżamm ANC > 2.0 x 109/L, bil-frekwenza medja tad dożaġġ tkun ta' tlett ijiem fil-ġimgħa.
English: Medicinal products (containing sorbitol/fructose) given intravenously may be life-threatening and should not be given in this population unless there is an overwhelming clinical need and no alternatives are available.
Maltese: Prodotti mediċinali (li fihom sorbitol/fructose) mogħtija fil-vini jistgħu jkunu ta' periklu għall-ħajja u m'għandhomx jingħataw lil din il-popolazzjoni sakemm ma jkunx hemm ħtieġa klinika kbira ħafna u ma tkun disponibbli l-ebda alternattiva.
English: Filgrastim was studied in repeated dose toxicity studies up to 1 year in duration which revealed changes attributable to the expected pharmacological actions including increases in leukocytes, myeloid hyperplasia in bone marrow, extramedullary granulopoiesis and splenic enlargement.
Maltese: L-uniku avveniment avvers irrappurtat b'mod konsistenti kien uġigħ muskoluskeletriku, li mhuwiex differenti mill-esperjenza filpopolazzjoni adulta.
English: Each pre-filled syringe contains either 0.5 mL or 0.8 mL of solution.
Maltese: 5 siringi mimlijin għal-lest b'0.8 mL.
English: One retrospective European study evaluating the use of G-CSF after allogeneic bone marrow transplantation in patients with acute leukaemias suggested an increase in the risk of GvHD, treatment related mortality (TRM) and mortality when G-CSF was administered.
Maltese: Studju retrospettiv Ewropew li evalwa l-użu ta' G-CSF wara trapjant alloġeniku tal-mudullun f'pazjenti b'lewkimji akuti, issuġġerixxa żieda fir-riskju ta' GvHD, mortalità marbuta mal-kura
English: Ratiograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Maltese: Ratiograstim hu indikat għat-tnaqqis fid-dewmien ta' newtropenja u fl-inċidenza ta' newtropenja biddeni f'pazjenti kkurati b'kimoterapija ċitotossika stabbilita kontra malinni (bl-eċċezzjoni ta' lewkimja majelojde kronika u sindromi majelodisplastiċi) u għat-tnaqqis fid-dewmien ta' newtropenja f'pazjenti, taħt kura majeloablativa u segwita bit-trapjant tal-mudullun, li huma meqjusa li għandhom riskju għola ta' newtropenja qawwija u mdewma.
English: • increase in white blood cells (leukocytosis)
Maltese: • żieda fiċ-ċelluli bojod tad-demm (lewkoċitosi)
English: • fever (pyrexia)
Maltese: • dgħufija ġeneralizzata (astenija)
English: The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MIU (10 μg)/kg/day for 5 to 7 consecutive days.
Maltese: MIU (10 μg)/kg/jum mogħtija għal 5 sa 7 ijiem konsekuttivi.
English: There is insufficient data to further evaluate filgrastim use in paediatric subjects.
Maltese: M'hemmx biżżejjed data biex jiġi evalwat aktar l-użu ta' filgrastim f'individwi pedjatriċi.
English: Graft versus Host
Maltese: Uġigħ fis sidera
English: Some cytotoxic agents exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Maltese: Għaldaqstant, huwa diffiċli biex jiġi rakkomandat l-aħjar metodu.
English: - sickle cell anaemia, as this medicine may cause sickle cell crisis - osteoporosis (bone disease).
Maltese: Sib post komdu, mdawwal sew u poġġi dak kollu li għandek bżonn fejn tista' tilħaqhom.
English: The recommended starting dose is 0.5 MIU (5 μg)/kg/day as a single dose or in divided doses.
Maltese: MIU (10 μg)/kg/jum għal 4 sa 5 ijiem konsekuttivi.
English: 50 mg/ml Oral suspension
Maltese: 50mg/mL Sospensjoni orali Użu orali
English: 1 bottle + 10 ml dosing syringe
Maltese: 1 flixkun+ 10 mL siringa taddożaġġ
English: Bottle (HDPE)
Maltese: Isem (ivvintat)
English: Bottle (HDPE) 225 ml
Maltese: 225 mL
English: EU number
Maltese: Kontenut
English: 700 mg Film-coated tablets
Maltese: Qawwa Għamla farmaċewtika
English: EMEA Number
Maltese: Numru tal-UE
English: Pharmaceutical Form Route of Administration Packaging Package size l t o r
Maltese: Daqs tal-pakkett t x
English: (Invented) name Strength
Maltese: Isem (inventat) Qawwa Għamla farmaċewtika
English: --1 Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ≥ 5.3 log10 FAID50*/ml Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) ≥ 5.3 log10 FAID50*/ml * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
Maltese: --1 Influenza A/eq Ohio/03 {H3N8}virus rikombinat tal-canarypox (vCP2242) >5.3 log 10 FAID50*/ml Influenza A/eq/Richmond/1/07 {H3N8} virus rikombinat tal-canarypox (vCP3011) >5.3 log 10 FAID50*/ml * Il-kontenut tal-vCP iċċekjat bil-FAID50 globali (doża infettiva florexxenti ta' prova 50 %) u r-ratio qPCR bejn vCP.
English: Suspension for injection
Maltese: Suspensjoni għallinjezzjoni
English: Packaging Content Package Size
Maltese: Ippakkjar Kontenut Daqs talpakkett
English: 10 vials Zero days
Maltese: 10 fjali
English: Target Species
Maltese: Żwiemel
English: Horses Intramuscular use Vial (glass) 1 ml
Maltese: Numru tal-UE Isem kummerċjali
English: Withdrawal period
Maltese: Perijodu ta' tiżmim
English: Further information on Fulphila can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/fulphila.
Maltese: ema.europa.eu/medicines/human/EPAR/fulphila.
English: The active substance in Fulphila, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Maltese: Is-sustanza attiva f'Fulphila, il-pegfilgrastim, hija forma ta' filgrastim, simili ħafna għal proteina talbniedem imsejħa fattur stimulanti tal-kolonja tal-granuloċiti (G-CSF).
English: Fulphila is a ‘biosimilar medicine'.
Maltese: Fulphila huwa "mediċina bijosimili".
English: Other information about Fulphila
Maltese: Informazzjoni oħra dwar Fulphila
English: The reference medicine for Fulphila is Neulasta.
Maltese: Il-mediċina ta' referenza għal Fulphila hija Neulasta.
English: Laboratory studies comparing Fulphila with Neulasta have shown that the active substance in Fulphila is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li qabblu Fulphila ma' Neulasta wrew li s-sustanza attiva f'Fulphila hija simili ħafna għal dik f'Neulasta f'termini ta' struttura, purità u attività bijoloġika.
English: In addition, a study involving 194 patients who had chemotherapy before or after surgery for breast cancer showed that Fulphila was as effective as Neulasta in reducing the duration of neutropenia.
Maltese: Barra minn hekk, studju li involva 194 pazjent li ħadu l-kimoterapija qabel jew wara kirurġija għallkanċer tas-sider wera li Fulphila kien effettiv daqs Neulasta fit-tnaqqis tat-tul ta' newtropenija.
English: What are the risks associated with Fulphila?
Maltese: X'inhuma r-riskji assoċjati ma' Fulphila?
English: Fulphila is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Maltese: Fulphila jingħata bħala doża waħda ta' 6 mg li tiġi injettata taħt il-ġilda mill-inqas 24 siegħa wara t-tmiem ta' kull ċiklu ta' kimoterapija (kura b'mediċini tal-kanċer).
English: In Fulphila, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: F'Fulphila, filgrastim ġie “pegilat” (twaħħal ma' kimika msejħa polietilenglikol).
English: Pain in muscles is also common.
Maltese: Uġigħ fil-muskoli huwa komuni wkoll.
English: Fulphila is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Maltese: Fulphila mhuwiex maħsub biex jintuża f'pazjenti bil-lewkimja majelojde kronika tal-kanċer tad-demm jew b'sindromi majelodisplastiċi (kundizzjonijiet li fihom jiġu prodotti għadd kbir ta' ċelloli tad-demm anormali, li jistgħu jiżviluppaw f'lewkimja).
English: All these data were considered sufficient to conclude that Fulphila will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Fulphila ser jaġixxi bl-istess mod bħal Neulasta f'termini ta' effettività u sigurtà fl-użu approvat tiegħu.
English: For the full list of side effects and restrictions with Fulphila, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet irrappurtati b'Fulphila, ara l-fuljett ta' tagħrif.
English: As for all medicines, data on the use of Fulphila are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Fulphila hija ssorveljata kontinwament.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Fulphila has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Fulphila għandu struttura, purità u attività bijoloġika simili ħafna għal Neulasta u jiġi distribwit bl-istess mod fil-ġisem.
English: This means that Fulphila is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Fulphila huwa simili ħafna għal mediċina bijoloġika oħra (il-"mediċina ta' referenza") li diġà hija awtorizzata fl-UE.
English: Fulphila is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Maltese: Fulphila huwa mediċina li tintuża f'pazjenti bil-kanċer biex tgħin fin-newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), li hija effett sekondarju komuni tal-kura tal-kanċer u tista' twassal biex il-pazjenti jsiru vulnerabbli għall-infezzjonijiet.
English: How does Fulphila work?
Maltese: Kif jintuża Fulphila?
English: What measures are being taken to ensure the safe and effective use of Fulphila?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Fulphila?
English: Side effects reported with Fulphila are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Fulphila huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The safety of Fulphila has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Maltese: Is-sigurtà ta' Fulphila ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji tal-mediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza Neulasta.
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever).
Maltese: Dan jingħata speċifikament biex jitnaqqas it-tul ta' żmien tan-newtropenija u biex tiġi evitata nnewtropenija bid-deni (meta n-newtropenija tkun akkumpanjata minn deni).
English: Why is Fulphila authorised in the EU?
Maltese: Għaliex Fulphila huwa awtorizzat fl-UE?
English: The full EPAR for Clopidogrel Apotex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (75 mg).
Maltese: Jiġi f'pilloli (75 mg).
English: Clopidogrel Apotex clopidogrel
Maltese: Clopidogrel Apotex klopidogrel
English: Previously known as Clopidogrel Mylan Pharma.
Maltese: Qabel magħruf bħala Clopidogrel Mylan Pharma.
English: Clopidogrel Apotex is a ‘generic medicine'.
Maltese: Clopidogrel Apotex huwa ‘mediċina ġenerika'.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Mylan Pharma on 16 October 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Clopidogrel Mylan Pharma fis-16 ta' Ottubru 2009.
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Maltese: • fibrillazzjoni atrijali (kontrazzjonijiet irregolari u mgħaġġla tal-kavitajiet fuqana tal-qalb).
English: The name of the medicine was changed to Clopidogrel Apotex on 20 January 2010.
Maltese: L-isem tal-mediċina nbidel u sar Clopidogrel Apotex fl-20 ta' Jannar 2010.
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel Apotex is used together with aspirin, the dose of which should not be higher than 100 mg.
Maltese: Fil-każi ta' sindromu koronarju akut u ta' fibrillazzjoni atrijali, Clopidogrel Apotex jittieħed ma' aspirina u f'dal-każi d-doża m'għandhiex taqbeż il100 mg.
English: This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel Apotex.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Clopidogrel Apotex.
English: The active substance in Clopidogrel Apotex, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva ta' Clopidogrel Apotex, il-klopidogrel, hija inibitur tal-aggregazzjoni tal-pjastrini.
English: Clopidogrel Apotex is used to prevent problems caused by blood clots in adults who have:
Maltese: Clopidogrel Apotex jintuża biex jipprevjeni problemi kkawżati minn emboli f'adulti li:
English: In acute coronary syndrome, treatment generally starts with a loading dose of four 75-mg tablets.
Maltese: Fis-sindromu koronarju akut, ġeneralment it-trattament jibda b'doża ta' tagħbija ta' erba' pilloli ta' 75-mg.
English: This means that Clopidogrel Apotex is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Dan jfisser li Clopidogrel Apotex huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: The standard dose of Clopidogrel Apotex is one 75-mg tablet once a day.
Maltese: Id-doża rakkomandata ta' Clopidogrel Apotex hija pillola waħda ta' 75-mg kuljum.
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Apotex has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Clopidogrel Apotex wera li għandu kwalità kumparabbli ma' Plavix u li huwa bijoekwivalenti għalih.
English: Because Clopidogrel Apotex is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Billi Clopidogrel Apotex huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet li jiddeterminaw ilbijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: Because Clopidogrel Apotex is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Billi Clopidogrel Apotex huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċju u r-riskju tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: What is Clopidogrel Apotex?
Maltese: X'inhu Clopidogrel Apotex?
English: Clopidogrel Apotex is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Apotex huwa mediċina li fiha s-sustanza attiva klopidogrel.
English: What are the benefits and risks of Clopidogrel Apotex?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Clopidogrel Apotex?
English: Why has Clopidogrel Apotex been approved?
Maltese: Għaliex ġie approvat Clopidogrel Apotex?
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Maltese: Jintuża f'dawk il-pazjenti li jkollhom talinqas riskju wieħed li jiżviluppawlhom problemi vaskulari bħal attakk tal-qalb jew puplesija, li ma jkunux jistgħu jieħdu antagonisti tal-vitamina K (mediċini oħra li jevitaw l-emboli) u li jkunu f'riskju baxx li jkollhom emorraġija.
English: How has Clopidogrel Apotex been studied?
Maltese: Kif ġie studjat Clopidogrel Apotex?
English: Clopidogrel Apotex can be started between a few days and 35 days after the attack;
Maltese: Clopidogrel Apotex jista' jinbeda fl-ewwel ftit jiem wara l-attakk u sa 35 ġurnata wara;
English: Content
Maltese: Qawwa
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Maltese: Kontenut Daqs tal-pakkett skarto 1
English: 1 cartridge
Maltese: Mnejn jingata
English: Xermelo contains the active substance telotristat.
Maltese: Xermelo fih is-sustanza attiva telotristat.
English: The active substance in Xermelo, telotristat, blocks the action of enzymes called L-tryptophan hydroxylases.
Maltese: Is-sustanza attiva fi Xermelo, it-telotristat, timblokka l-azzjoni ta' enzimi bl-isem ta' L-tryptophan hydroxylases.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Xermelo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Xermelo jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR for Xermelo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Xermelo.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Xermelo.
English: Other information about Xermelo
Maltese: Informazzjoni oħra dwar Xermelo
English: Patients taking placebo were having an average of 5.2 bowel movements daily at the start, which fell to an average of 4.6 movements daily, a fall of 0.6 movements.
Maltese: Il-pazjenti li kienu qed jieħdu plaċebo, fil-bidu kien qed ikollhom medja ta' 5.2 movimenti fil-musrana kuljum, li naqset għal medja ta' 4.6 movimenti kuljum, tnaqqis ta' 0.6 movimenti.