FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/08/496/013 EU/1/08/496/014 EU/1/08/496/015 EU/1/08/496/016
Maltese: EU/1/08/496/013 EU/1/08/496/014
English: Transient cytogenetic abnormalities have been observed in normal donors following G-CSF use.
Maltese: Anormalitajiet ċitoġenetiċi transitorji ġew osservati f'donaturi b'saħħithom wara l-użu ta' G-CSF.
English: Filgrastim HEXAL 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: Għall-infużjonijiet, filgrastim għandu jiġi dilwit f'20 ml ta' 5% ta' soluzzjoni ta' glucose (ara sezzjoni 6.6). Filgrastim għal mobilizzazzjoni tal-PBPC wara kimoterapija majelosoppressiva:
English: Paediatric use in the SCN and cancer settings
Maltese: Użu pedjatriku f'pazjenti li għandhom SCN u kanċer
English: The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Maltese: Id-dejta fit-tabelli t'hawn taħt tiddeskrivi r-reazzjonijiet avversi rrappurtati minn provi kliniċi u minn rappurtaġġ spontanju.
English: Hyperuricaemia Blood uric acid increased
Maltese: Iperuriċemija Żieda ta' uric acid fid-demm
English: Fatiguea Mucosal inflammationa Pyrexia
Maltese: Kif gћandek tuża Filgrastim HEXAL
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: F'pazjenti li jkun qed isirilhom trapjant ta' ċelluli staminali jew tal-mudullun, tista' sseħħ Graft versus Host Disease - din hi reazzjoni taċ-ċelluli tad-donatur kontra l-pazjent li jkun qed jirċievi t-trapjant; sinjali u sintomi jinkludu raxx fuq il-pali ta' jdejk jew fil-qiegħ ta' saqajk u ulċeri u feriti fil-ħalq, fl-imsaren, fil-fwied, fil-ġilda jew fl-għajnejn, fil-pulmun, fil-vaġina u fil-ġogi tiegħek.
English: Thrombocytopenia has been reported in patients receiving filgrastim.
Maltese: Tromboċitopenija ġiet irrappurtata f'pazjenti li jirċievu filgrastim.
English: EU/1/08/496/005 EU/1/08/496/006 EU/1/08/496/007 EU/1/08/496/008
Maltese: EU/1/08/496/007 EU/1/08/496/008
English: Instructions on how to inject yourself
Maltese: L-inċidenza ta'
English: Bone density decreased Exacerbation of rheumatoid arthritis
Maltese: Sensittività eċċessiva għallmediċinaa
English: Mobilisation of PBPC does not provide a direct clinical benefit to normal donors and should only be considered for the purposes of allogeneic stem cell transplantation.
Maltese: Il-mobilizzazzjoni tal-PBPC ma tipprovdix benefiċċju kliniku dirett lil donaturi normali u għandha tiġi kkunsidrata biss għall-iskop ta' trapjant ta' ċelluli staminali alloġeneiċi.
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Maltese: Għandha tingħata attenzjoni partikulari biex wieħed jiddistingwi d-dijanjosi tat-trasformazzjoni tal-blasts ta' lewkemija majelojde kronika minn lewkemija majelojde akuta.
English: Patients with a recent history of lung infiltrates or pneumonia may be at higher risk.
Maltese: Pazjenti bi storja medika riċenti ta' infiltrati tal-pulmun jew pnewmonja jistgħu jkunu f'riskju ogħla.
English: 0.5 MU/kg/day (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: MU/kg/kuljum (5 μg/kg/kuljum) mill-ewwel jum wara t-tlestija tal-kimoterapija sakemm l-għadd minimu mistenni tan-newtrofili jkun għadda u l-għadd tan-newtrofili jkun irkupra għal medda normali.
English: There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
Maltese: M'hemm l-ebda evidenza li pazjenti b'infezzjoni bl-HIV kkurati b'filgrastim juru żieda fir-replikazzjoni tal-HIV.
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.
Maltese: Il-lewkaferesi għandha tinbeda f'jum 5 u titkompla sa jum 6 jekk meħtieġ sabiex tiġbor 4 x 106 CD34+ ċelluli/kg ta' piż tal-ġisem tar-reċipjent.
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Maltese: Bħal ma jiġri fil-każ ta' fatturi tat-tkabbir ematopojetiċi oħrajn, G-CSF wera proprjetajiet li jistimulaw in vitro fuq ċelluli endoteljali umani.
English: Effect of chemotherapy on erythrocytes and thrombocytes
Maltese: Effett ta' kimoterapija fuq eritroċiti u tromboċiti
English: • severe pain in the bones, chest, gut or joints (sickle cell anaemia with crisis)
Maltese: • uġigħ sever fl-għadam, fis-sider, fl-imsaren jew fil-ġogi (kriżi taċ-ċelluli sickle)
English: There is insufficient data to further evaluate filgrastim use in paediatric subjects.
Maltese: M'hemmx dejta biżżejjed biex jiġi evalwat b'mod addizzjonali l-użu ta' filgrastim f'individwi pedjatriċi.
English: Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ml for 8 - 16 hours.
Maltese: Jekk inti donatur ta' ċelluli staminali, inti jrid ikollok bejn 16 u 60 sena.
English: - 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 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: • Dawn jistgħu jkunu sintomi ta' kundizzjoni msejħa “sepsis” (imsejħa wkoll "avvelenament tad demm"), infezzjoni severa b'rispons infjammatorju mal-ġisem kollu li jista' jkun ta' theddida għall-ħajja u jeħtieġ attenzjoni medika urġenti.
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna fuq it-tikketta tas-siringa wara EXP.
English: The full EPAR for Voncento 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: Voncento's effects were rated excellent in around 92% (371 out of 405) of the bleeding episodes and good in around 7% (27 out of 405) of episodes.
Maltese: L-effetti ta' Voncento kienu kklassifikati bħala eċċellenti f'madwar 92% (371 minn 405) talepisodji ta' emorraġija u tajjeb f'madwar 7% (27 minn 405) tal-episodji.
English: Other information about Voncento
Maltese: Informazzjoni oħra dwar Voncento
English: Why is Voncento approved?
Maltese: Għaliex ġie approvat Voncento?
English: This is a summary of the European public assessment report (EPAR) for Voncento.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Voncento.
English: Similar ratings were seen when Voncento was used for prevention.
Maltese: Klassifikazzjonijiet simili dehru meta Voncento ntuża għall-prevenzjoni.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Voncento on 12 August 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Voncento fit-12 ta' Awwissu 2013.
English: In this study, when used to treat bleeding, Voncento was rated excellent in 60% (396 out of 656) of the bleeding events and good in 36% (236 out of 656) of the bleeding events.
Maltese: F'dan l-istudju, meta ntuża għall-kura tal-emorraġija, Voncento kien ikklassifikat bħala eċċellenti f'60% (396 minn 656) tal-avvenimenti ta' emorraġija u tajjeb f'36% (236 minn 656) tal-avvenimenti ta' emorraġija.
English: Voncento has been studied in one main study involving 22 patients (including adolescents) with severe von Willebrand disease to assess its effects in stopping non-surgical bleeding episodes or as preventive treatment.
Maltese: Voncento ġie studjat fi studju ewlieni wieħed li fih ħadu sehem 22 pazjent (inkluż adolexxenti) bilmarda ta' von Willebrand severa biex jiġu vvalutati l-effetti tiegħu fit-twaqqif ta' episodji mhux kirurġiċi ta' emorraġija jew bħala kura preventiva.
English: Voncento human coagulation factor VIII / human von Willebrand factor
Maltese: Sommarju tal-EPAR għall-pubbliku fattur tal-koagulazzjoni VIII tal-bniedem / fattur von Willebrand tal-bniedem
English: Its side effects were generally mild to moderate and were considered typical for this type of medicine.
Maltese: L-effetti sekondarji tiegħu kienu ġeneralment ħfief għal moderati u kienu meqjusa tipiċi għal din it-tip ta' mediċina.
English: What are the risks associated with Voncento?
Maltese: X'inhuma r-riskji assoċjati ma' Voncento?
English: This causes problems with blood clotting, leading to bleeding in the joints, muscles or internal organs.
Maltese: Dan jikkawża problemi bil-koagulazzjoni, li jwassal għal emorraġija fil-ġogi, muskoli jew organi interni.
English: Clotting in blood vessels, taste disturbances and abnormal results in liver function tests are uncommon effects (affecting between 1 and 10 in 1000 people).
Maltese: Koagulazzjoni fil-vażijiet, disturbi fittogħma u riżultati anormali fit-testijiet tal-funzjoni tal-fwied huma effetti mhux komuni (li jaffettwaw bejn persuna 1 u 10 f'kull 1000 persuna).
English: Voncento was also effective for preventing and treating bleeding related to surgery.
Maltese: Voncento kien ukoll effettiv fil-prevenzjoni u l-kura ta' emorraġija relatata ma' kirurġija.
English: This part of the study showed that the average number of bleeding events in patients on preventive treatment was reduced from between 18 and 82 events during the year before the preventive treatment to between 1 and 6 events.
Maltese: Din il-parti tal-istudju wriet li l-medja tan-numru tal-avvenimenti ta' emorraġija f'pazjenti li kienu qed jieħdu kura preventiva tnaqqset minn bejn 18 u 82 avveniment matul is-sena ta' qabel il-kura preventiva għal bejn 1 u 6 avvenimenti.
English: Other common side effects (affecting up to 1 in 10 people) include hypersensitivity (allergic) reactions and fever.
Maltese: Effetti sekondarji komuni oħra (li jaffettwaw persuna 1 minn kull 10) jinkludu reazzjonijiet ta' ipersensittività (reazzjonijiet allerġiċi) u deni.
English: The benefits of Voncento in preventing and treating bleeding episodes in haemophilia A were shown in a study of 81 patients who had previously been treated with human coagulation factor VIII.
Maltese: Il-benefiċċji ta' Voncento fil-prevenzjoni u l-kura ta' episodji ta' emorraġija fl-emofilja A ntwerew fi studju ta' 81 pazjent li kienu rċevew kura preċedenti bil-fattur tal-koagulazzjoni VIII tal-bniedem.
English: There is a risk that some patients will develop inhibitors (antibodies) against factor VIII or von Willebrand factor, causing the medicine to stop working and resulting in a loss of bleeding control.
Maltese: Hemm ukoll riskju li ċerti pazjenti jiżviluppaw inibituri (antikorpi) kontra l-fattur VIII jew il-fattur von Willebrand, li jikkawżaw lill-mediċina li tieqaf tkun effikaċi u dan jirriżulta f'telf tal-kontroll talemorraġija.
English: Voncento is available as a powder and solvent that are mixed together to make a solution for injection or infusion (drip) into a vein.
Maltese: Voncento jiġi bħala trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għal injezzjoni jew infużjoni (dripp) ġo vina.
English: Voncento is a medicine used for treating and preventing bleeding in patients with von Willebrand disease (an inherited bleeding disorder caused by lack of von Willebrand factor) when another medicine called desmopressin is ineffective or cannot be given.
Maltese: Voncento huwa mediċina li tintuża fil-kura u l-prevenzjoni ta' emorraġija f'pazjenti bil-marda ta' von Willebrand (disturb ta' emorraġija li jintiret ikkawżat minn nuqqas tal-fattur von Willebrand) meta mediċina oħra msejħa desmopressin ma tkunx effettiva jew ma tkunx tista' tingħata.
English: Voncento is injected or infused slowly into a vein.
Maltese: Voncento jiġi injettat jew infuż bil-mod fil-vina.
English: The Agency noted that Voncento was shown to be effective in treating and preventing bleeding in patients with haemophilia A as well as in patients with von Willebrand disease.
Maltese: L-Aġenzija nnutat li Voncento intwera li huwa effettiv fil-kura u l-prevenzjoni ta' emorraġija f'pazjenti b'emofilja A kif ukoll fil-pazjenti bil-marda ta' von Willebrand.
English: The Agency decided that Voncento's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: L-Aġenzija ddeċidiet li l-benefiċċji ta' Voncento huma akbar mir-riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: For the full list of all side effects and restrictions with Voncento, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Voncento, ara l-fuljett ta' tagħrif.
English: The dose and duration of treatment depend on whether Voncento is used to treat or prevent bleeding or during surgery and whether it is used in patients with haemophilia A or von Willebrand disease.
Maltese: Id-doża u t-tul tal-kura jiddependu minn jekk Voncento jintużax għall-kura jew għall-prevenzjoni ta' emorraġija jew matul kirurġija u jekk jintużax f'pazjenti bl-emofilja A jew bil-marda ta' von Willebrand.
English: It contains two active substances, human coagulation factor VIII and human von Willebrand factor.
Maltese: Hu fih żewġ sustanzi attivi, il-fattur tal-koagulazzjoni VIII talbniedem u l-fattur von Willebrand tal-bniedem.
English: Five patients in totalall of them undergoing major knee surgery - required blood transfusion.
Maltese: Total ta' ħames pazjenti - li kollha saritilhom operazzjoni maġġuri tal-irkoppa - kienu jeħtieġu trasfużjoni tad-demm.
English: EU (MA) Number
Maltese: UE (MA) Numru
English: EU/1/15/1013/001
Maltese: EU/1/15/1013/001 Lumark
English: Strength Pharmaceutical Form
Maltese: Qawwa Forma Farmaċewtika
English: Radiopharmaceutic al precursor, solution vial (glass)
Maltese: Prekursur radjufarmaċewtiku , soluzzjoni kunjett (ħġieġ)
English: 10 ml
Maltese: 10 ml kunjett 1
English: Lumark
Maltese: Isem (ivvintat)
English: Zyprexa olanzapine
Maltese: Zyprexa olanzapina
English: The full EPAR for Zyprexa 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 (2.5, 5, 7.5, 10, 15 and 20 mg) and as a powder to be made up into a solution for injection.
Maltese: Jiġi bħala pilloli (2.5, 5, 7.5, 10, 15, u 20 mg) u bħala trab għal soluzzjoni għall-injezzjoni.
English: The active substance in Zyprexa, olanzapine, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Zyprexa, l-olanzapina, hija mediċina antipsikotika.
English: In the prevention of manic episodes, Zyprexa tablets were studied in 1,162 adults.
Maltese: Fil-prevenzjoni ta' episodji manijaċi, il-pilloli Zyprexa ġew studjati f'1,162 adult.
English: This is a summary of the European public assessment report (EPAR) for Zyprexa.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zyprexa.
English: Zyprexa is a medicine containing the active substance olanzapine.
Maltese: Zyprexa huwa mediċina li fiha s-sustanza attiva olanzapina.
English: The injection was studied in 581 adults with schizophrenia (compared with placebo or injected haloperidol) and 228 manic adults (compared with placebo or injected lorazepam, another medicine used in manic episodes).
Maltese: L-injezzjoni ġiet studjata f'581 adult bl-iskiżofrenija (imqabbla ma' plaċebo jew haloperidol injettat) u f'228 adult manijaku (imqabbla ma' plaċebo jew ma' lorazepam injettat, mediċina oħra użata fl-episodji manijaċi).
English: What is the risk associated with Zyprexa?
Maltese: X'inhu r-riskju assoċjat ma' Zyprexa?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zyprexa on 27 September 1996.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zyprexa fis-27 ta' Settembru 1996.
English: The recommended starting dose of Zyprexa tablets depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Maltese: Doża ta' 10 mg kuljum tintuża għall-iskiżofrenija u fil-prevenzjoni ta' episodji manijaċi, u 15 mg kuljum fit-trattament ta' episodji manijaċi, sakemm ma tintużax ma' mediċini oħra, f'liema każ id-doża inizjali tista' tkun ta' 10 mg kuljum.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5hydroxytrypamine (also called serotonin) and dopamine.
Maltese: Hu maħsub li l-effett benefiku tal-olanzapina huwa dovut għall-imblokkar tar-riċetturi għan-newrotrażmettituri 5-idrossitripamina (5-hydroxytrypamine, imsejħa wkoll serotonina) u dopamina.
English: In all studies, the effectiveness of Zyprexa was assessed using various symptom-rating scales.
Maltese: Fl-istudji kollha, l-effikaċja ta' Zyprexa ġiet valutata permezz ta' diversi skali tal-valutazzjoni tassintomi.
English: What is Zyprexa?
Maltese: X'inhi Zyprexa?
English: Zyprexa is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Maltese: Zyprexa jintuża wkoll fil-kura ta' episodji manijaċi moderati sa severi (burdata tajba b'mod estrem) f'adulti.
English: In schizophrenia, Zyprexa tablets have been studied in about 3,000 adults, in which their effectiveness was compared with that of placebo (a dummy treatment) or haloperidol (another antipsychotic medicine).
Maltese: Fl-iskiżofrenija, il-pilloli Zyprexa ġew studjati f'madwar 3,000 adult fejn l-effikaċja tagħhom tqabblet ma' dik ta' plaċebo (trattamet finta) jew ma' haloperidol (mediċina antipsikotika oħra).
English: Lower doses may be needed for patients over 65 years of age (5 mg per day for the tablets and 2.5 to 5 mg for the injection) and for patients who have reduced liver or kidney function (5 mg per day for both the tablets and injection).
Maltese: Pazjenti ta' iktar minn 65 sena jista' jkollhom bżonn dożi iktar baxxi (5 mg kuljum għall-pilloli u bejn 2.5 u 5 mg għall-injezzjoni) kif ukoll pazjenti li jkollhom problemi bil-fwied jew bil-kliewi (5 mg kuljum kemm għall-pilloli kif ukoll għall-injezzjoni).
English: Why has Zyprexa been approved?
Maltese: Għaliex ġie approvat Zyprexa?
English: In the treatment of acute manic episodes in adults with bipolar disorder, Zyprexa tablets were compared with placebo, haloperidol or valproate (another medicine used in manic episodes) in five studies, including one where patients were also receiving other medicines.
Maltese: Fit-trattament ta' episodji manijaċi akuti f'adulti b'disturbi bipolari, il-pilloli Zyprexa tqabblu ma' plaċebo, ma' haloperidol jew ma' valproate (mediċina oħra użata fl-episodji manijaċi) f'ħames studji, inkluż wieħed li fih il-pazjenti kienu qed jieħdu wkoll mediċini oħra.
English: How has Zyprexa been studied?
Maltese: Kif ġie studjat Zyprexa?
English: Zyprexa is usually taken by mouth as tablets, but the injection can be used for the rapid control of agitation or disturbed behaviour in adults with schizophrenia or a manic episode, when taking the medicine by mouth is not appropriate.
Maltese: Zyprexa ġeneralment jittieħed oralment bħala pilloli, iżda l-injezzjoni tista' tintuża għall-kontroll rapidu ta' aġitazzjoni jew ta' mġiba disturbata f'adulti bi skiżofrenija jew b'episodji manijaċi, meta t-teħid talmediċina b'mod orali ma jkunx adatt.
English: The most common side effects with Zyprexa (seen in more than 1 patient in 10) are somnolence (sleepiness), weight gain, orthostatic hypotension (sudden drop in blood pressure on standing up) and raised levels of prolactin (a hormone).
Maltese: L-effetti sekondarji l-aktar komuni b'Zyprexa (li dehru f'iktar minn pazjent wieħed minn kull 10) huma somnolenza (ngħas), żieda fil-piż, ipotensjoni ortostatika (il-pressjoni tad-demm titbaxxa f'daqqa malqawmien bil-wieqfa) u żieda fil-livelli tal-prolaktin (ormon).
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Maltese: L-iskiżofrenija hija marda mentali li għandha numru ta' sintomi, inkluż disturbi fil-ħsieb u fid-diskors, alluċinazzjonijiet (id-dehra u s-smigħ ta' affarijiet li jkunu immaġinarji), suspetti u delirji (thewdin żbaljat).
English: In all studies, Zyprexa as tablets and as injections was more effective at improving symptoms than placebo.
Maltese: Fl-istudji kollha, Zyprexa bħala pilloli u injezzjoni kien aktar effettiv mill-plaċebo fit-titjib tas-sintomi.
English: In all cases, the maximum dose of Zyprexa that can be given in a day, using tablets or injection, is 20 mg.
Maltese: Fil-każi kollha, id-doża massima ta' Zyprexa li tista' tingħata f'jum wieħed, kemm bħala pilloli kif ukoll bħala injezzjoni, hi ta' 20 mg.
English: The injection was also shown to be more effective than lorazepam (at a relatively low dose) in manic patients, and as effective as haloperidol in schizophrenia.
Maltese: L-injezzjoni ntweriet ukoll li kienet iktar effettiva minn lorazepam (f'doża relattivament baxxa) f'pazjenti manijaċi, u effettiva daqs haloperidol fl-iskiżofrenija.
English: Their effectiveness was compared with that of placebo or lithium (another medicine used in bipolar disorder).
Maltese: L-effikaċja tagħhom tqabblet ma' dik ta' plaċebo jew tal-litju (mediċina oħra użata fid-disturbi bipolari).
English: For the full list of all side effects reported with Zyprexa, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Zyprexa, ara l-fuljett ta' tagħrif.
English: The full EPAR for Sprimeo HCT 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 (150 mg aliskiren and 12.5 mg hydrochlorothiazide; 150 mg aliskiren and 25 mg hydrochlorothiazide; 300 mg aliskiren and 12.5 mg hydrochlorothiazide; 300 mg aliskiren and 25 mg hydrochlorothiazide).
Maltese: Jiġi bħala pilloli (150 mg aliskiren u 12.5 mg idroklorotijażid; 150 mg aliskiren u 25 mg idroklorotijażide; 300 mg aliskiren u 12.5 mg idroklorotijażid; 300 mg aliskiren u 25 mg idroklorotijażid).
English: This summary was last updated in 04-2012.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'04-2012.
English: This is a summary of the European public assessment report (EPAR) for Sprimeo HCT.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Sprimeo HCT.
English: Aliskiren on its own has been authorised in the European Union (EU) since August 2007 as Rasilez, Sprimeo and Riprazo.
Maltese: Aliskiren meħudha weħidha ilha awtorizzata fl-Unjoni Ewropea (UE) minn Awwissu 2007 bħala Rasilez, Sprimeo u Riprazo.
English: The studies compared the combination of aliskiren and hydrochlorothiazide with placebo (a dummy treatment), with aliskiren or hydrochlorothiazide taken alone, or with other medicines for hypertension (valsartan, irbesartan, lisinopril or amlodipine).
Maltese: L-istudji qabblu t-taħlita talaliskiren mal-idroklorotijażide ma' plaċebo (trattament finta), mal-aliskiren jew mal-idroklorotijażid meħudin waħedhom jew ma' mediċini oħra għall-ipertensjoni (valsartan, irbesartan, lisinopril jew amlodipina).