FrancophonIA/ELRC3.0 huggingface dataset:
English: 9/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: 9/L) f'adulti b'infezzjoni avvanzata tal-HIV, sabiex inaqqas ir-riskju ta' infezzjonijiet batterjali meta għażliet oħrajn għall-immaniġġjar tan-newtropenija ma jkunux adattati.
English: If you are donating stem cells for yourself, the usual dose is 0.5 million units (5 micrograms) to 1 million units (10 micrograms) per kilogram bodyweight each day.
Maltese: Jekk qed tagħti ċelluli staminali għalik innifsek, id-doża tas-soltu hi ta' 0.5 miljun unità (5 mikrogrammi) sa 1 miljun unità (10 mikrogrammi) għal kull kilogramm ta' piż tal-ġisem kuljum.
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation with special attention to haematological values and infectious diseases.
Maltese: Il-mobilizzazzjoni tal-PBPC għandha tiġi kkunsidrata biss f'donaturi li jissodisfaw il-kriterji tal eliġibilità normali kliniċi u tal-laboratorju għal donazzjoni ta' ċelluli staminali b'attenzjoni speċjalilill-valuri ematoloġiċi u mard infettiv.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2. tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti tal-RMP.
English: Grastofil and neutropenia (low number of a type of white blood cells) in patients with HIV infection
Maltese: Grastofil u newtropenija (numru baxx ta' tip ta' ċelluli tad-demm bojod) f'pazjenti b'infezzjoni talHIV
English: Leave the syringe at room temperature (15ºC to 25 ºC) for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes.
Maltese: Ħalli s-siringa fit-temperatura tal-kamra (15 ºC sa 25 ºC) għal madwar 30 minuta jew żomm is-siringa mimlija għal-lest b'mod ġentili f'idejk għal ftit minuti.
English: The usual dose is 0.5 million units (5 micrograms) per kilogram of bodyweight each day.
Maltese: Id-doża tas-soltu hi ta' 0.5 miljun unità (5 mikrogrammi) għal kull kilogramm ta' piż tal-ġisem kuljum.
English: Grastofil dose adjustment
Maltese: Għalxiex jintuża Grastofil
English: Cutaneous vasculitis a
Maltese: Vaskulite tal-ġilda a
English: Telephone +39/02-89.421721
Maltese: Tel: +39/02-89.
English: Continuous infusion with filgrastim over a period of up to 28 days, in patients recovering from autologous bone-marrow transplantation, resulted in no evidence of drug accumulation and comparable half-lives.
Maltese: Infużjoni kontinwa b'filgrastim fuq perjodu sa 28 jum, f'pazjenti li jkunu qed jirkupraw minn trapjant awtologu tal-mudullun, ma rriżultat fl-ebda evidenza ta' akkumulazzjoni tal-mediċina u tal-half-lives tal-eliminazzjoni komparabbli.
English: The degree of variation between individual patients and between laboratory assays of CD34
Maltese: Il-grad ta' varjazzjoni bejn pazjenti individwali u bejn l-assaġġi tallaboratorju ta' ċelluli CD34
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: Filgrastim ġie studjat fi studji dwar tossiċità minn dożi ripetuti fi studju li dam sa sena, u dan żvela bidliet attribwibbli għall-azzjonijiet farmakoloġiċi mistennija li jinkludu żidiet fil-lewkoċiti, iperplasija majelojde fil-mudullun, granulopoiesis extramedullari u tkabbir tal-milsa.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Maltese: Ġeneralment, avvenimenti ta' glomerulonefrite fiequ wara tnaqqis fid-doża jew it-twaqqif ta' filgrastim u pegfilgrastim.
English: Grastofil 48 MU/0.5 mL solution for injection/infusion in pre-filled syringe
Maltese: Grastofil 48 MU/0.5 mL soluzzjoni għall-injezzjoni/infużjoni f'siringa mimlija għal-lest
English: If required, Grastofil may be diluted in 5% glucose solution for injection/infusion.
Maltese: Jekk ikun meħtieġ, Grastofil jista' jiġi dilwit f'soluzzjoni għall-injezzjoni/infużjoni ta' 5% ta' glucose.
English: Hypoaesthesia
Maltese: Epatomegalija
English: If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome (MDS)).
Maltese: Jekk int pazjent b'newtropenija kronika severa, int tista' tkun f'riskju li tiżviluppa kanċer tad-demm (lewkimja, sindrome majelodisplastiku (MDS)).
English: Paediatric patients in the SCN and cancer settings
Maltese: Pazjenti pedjatriċi li għandhom SCN u kanċer
English: A common side effect of Grastofil use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics).
Maltese: Effett sekondarju komuni tal-użu ta' Grastofil hu wġigħ fil-muskoli jew fl-għadam (uġigħ muskuloskeletriku), li jista' jittaffa billi tieħu mediċini standard ta' solliev mill-uġigħ (analġesiċi).
English: Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post-marketing experience.
Maltese: Reazzjonijiet ta' senisttività eċċessiva li jinkludu anafilassi, raxx, urtikarja, anġjoedema, dispneja u pressjoni baxxa, li seħħew mal-kura inizjali jew matul kura sussegwenti kienu irrappurtati fi studhi kliniċi u fl-esperjenza wara t-tqegħid.
English: Treatment with filgrastim significantly reduces the duration of febrile neutropenia, antibiotic use and hospitalisation after induction chemotherapy for acute myelogenous leukaemia or myeloablative therapy followed by bone marrow transplantation.
Maltese: Il-kura b'filgrastim tnaqqas b'mod sinifikanti it-tul ta' żmien kemm iddum in-newtropenija bid-deni, l-użu tal-antibijotiċi u ż-żmien li wieħed idum l-isptar wara l-kimoterapija tal-induzzjoni għal lewkimja majeloġena akuta jew terapija majeloablattiva segwita minn trapjant tal-mudullun.
English: Grastofil 30 MU/0.5 mL solution for injection/infusion in pre-filled syringe
Maltese: Grastofil 30 MU/0.5 mL soluzzjoni għall-injezzjoni/infużjoni f'siringa mimlija għal-lest
English: Keep the syringe in the outer carton in order to protect from light.
Maltese: Ematurija kienet komuni u proteinurija seħħet f'numru żgħir ta' pazjenti.
English: Mucosal inflammation a
Maltese: Infjammazzjoni talmukuża a
English: Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe chronic neutropenia receiving chronic treatment with filgrastim.
Maltese: Każijiet ta' tnaqqis fid-densità tal-għadam u osteoporożi ġew irrappurtati f'pazjenti pedjatriċi b'newtropenija kronika severa li kienu qed jirċievu kura kronika b'filgrastim.
English: Grastofil can be used:
Maltese: Grastofil jista' jintuża:
English: For the mobilisation of peripheral blood progenitor cells (PBPC) in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Maltese: Għall-mobilizzazzjoni ta' ċelluli proġenituri tad-demm periferali (PBPC) f'pazjenti li jkunu qed jirċievu terapija majelosoppressiva jew majeloablattiva segwita minn trapjant PBPC awtologu
English: For infusions Grastofil should be diluted in 20 mL of 5% glucose solution (see section 6.6).
Maltese: Għall-infużjonijiet, Grastofil għandu jiġi dilwit f'20 mL ta' soluzzjoni ta'5% ta' glucose (ara sezzjoni 6.6).
English: The recommended dose of Grastofil for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MU/kg/day (5 micrograms/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/jum (5 mikrogrammi/kg/jum) mill-ewwel jum wara t-tlestija talkimoterapija sakemm l-għadd minimu mistenni tan-newtrofili jkun għadda u l-għadd tan-newtrofili jkun irkupra għal medda normali.
English: Grastofil for PBPC mobilisation after myelosuppressive chemotherapy Grastofil should be given by subcutaneous injection.
Maltese: Grastofil għall-mobilizzazzjoni ta' PBPC wara kimoterapija majelosoppressiva Grastofil għandu jingħata bħala injezzjoni taħt il-ġilda.
English: The usual starting dose is 1 million units (10 micrograms) per kilogram of bodyweight each day given as an infusion.
Maltese: Id-doża normali tal-bidu hi ta' 1 miljun unità (10 mikrogrammi) għal kull kilogramm ta' piż tal-ġisem kuljum mogħtija bħala infużjoni.
English: Pulmonary adverse reactions, in particular interstitial lung disease, have been reported after G-CSF administration.
Maltese: Reazzjonijiet avversi pulmonari, b'mod partikulari mard interstizjali tal-pulmun, ġew irrappurtati wara l-għoti ta' G-CSF.
English: The first dose of Grastofil should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
Maltese: Meta tuża mediċini oħra M'għandekx tirċievi Grastofil fl-24 siegħa qabel u fl-24 siegħa wara li tirċievi kimoterapija.
English: Some cases of splenic rupture were fatal (see section 4.4).
Maltese: tad-donaturi (ara sezzjoni 4.4).
English: There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section Description of selected adverse reactions)
Maltese: Kien hemm rapporti ta' GvHD u fatalitajiet f'pazjenti wara trapjant alloġeneiku tal-mudullun (ara sezzjoni Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain d
Maltese: Dawn il-PBPCs awtologi jistgħu jinġabru u jingħataw bħala infużjoni wara terapija ċitotossika b'doża għolja, jew minflok, jew flimkien mat-trapjant tal-mudullun.
English: • in patients with advanced HIV infection which will help reduce the risk of infections;
Maltese: • f'pazjenti b'infezzjoni avvanzata tal-HIV, u dan se jgħin biex inaqqas ir-riskju ta' infezzjonijiet;
English: Oropharyngeal pain a, e
Maltese: Qtugħ ta' nifs Sogħla a
English: Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.
Maltese: Wara t-tmiem tat-terapija b'filgrastim, l-għadd tan-newtrofili li jkunu jiċċirkolaw jonqos b'50% fi żmien minn jum sa jumejn, u jiġi lura għal-livelli normali żmien 1 sa 7 ijiem.
English: Effect of chemotherapy on erythrocytes and thrombocytes Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive chemotherapy.
Maltese: Il-kura b'filgrastim waħdu ma tipprekludix tromboċitopenija u anemija minħabba kimoterapija majelsoppressiva.
English: Urinary tract infection
Maltese: Infezzjoni filpassaġġ urinarju
English: Leukocytosis a
Maltese: Infjammazzjoni tal-mukuża a
English: • rejection of transplanted bone marrow (graft versus host disease)
Maltese: • rifjut tal-mudullun ittrapjantat (marda tat-trapjant kontra l-ospitu)
English: The data in the tables below describe adverse reactions reported from clinical studies and spontaneous reporting.
Maltese: Id-dejta fit-tabelli t'hawn taħt tiddeskrivi reazzjonijiet avversi rrappurtati minn studji kliniċi u rappurtaġġ spontanju.
English: It is unknown whether filgrastim / metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk filgrastim/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: Grastofil therapy should only be given in collaboration with an oncology centre which has experience in granulocyte-colony stimulating factor (G-CSF) treatment and haematology and has the necessary diagnostic facilities.
Maltese: It-terapija b'Grastofil għandha tingħata biss b'kollaborazzjoni ma' ċentru ta' onkoloġija li jkollu lesperjenza fil-kura u l-ematoloġija tal-fattur tal-istimulazzjoni tal-kolonji tal-granuloċiti (G-CSF) u li jkollu l-faċilitajiet dijanjostiċi meħtieġa.
English: Transformation to leukaemia or myelodysplastic syndrome Special care should be taken in the diagnosis of SCNs to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia and myeloid leukaemia.
Maltese: Trasformazzjoni għal lewkimja jew sindrome majelodisplastiku Attenzjoni specjali trid tingħata fid-dijanjosi ta' SCNs biex tiddistingwihom minn disturbi ematopojetiċi oħrajn bħal anemija aplastika, majelodisplasija, u lewkimja majelodje.
English: In view of the possible risk of microbial contamination, Grastofil pre-filled syringes are for single use only.
Maltese: Minħabba r-riskju possibbli ta' kontaminazzjoni mikrobijali, issiringi mimlijin għal-lest ta' Grastofil huma mfasslin sabiex jintużaw darba biss.
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (jista' jaffetwa sa wieħed minn kull 100 persuni):
English: The no observed adverse effect level for embryo-fetal 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 tal-ebda effett osservat għal tossiċità tal-embriju u tal-fetu f'dan l-istudju kien ta' 10 μg/kg/jum, li jikkorrispondi għal esponiment sistemiku ta' madwar 3-5 darbiet tal-esponimenti osservati f'pazjenti kkurati bid-doża klinika.
English: Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported after granulocyte colony-stimulating factor administration, and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration.
Maltese: Sindrome ta' tnixxija kapillari, li jista' jkun ta' periklu għall-ħajja jekk it-trattament ikun ittardjat, ġie rrapportat wara għoti ta' fattur li jistimulta l-kolonja granuloċita, u huwa kkaratterizzat minn pressjoni baxxa, ipoalbuminemija, edema u emokonċentrazzjoni.
English: Chest pain a
Maltese: Għeja kbira a
English: See section 2 “What you need to know before you use Grastofil”.
Maltese: Ara sezzjoni 2 “X'għandek tkun taf qabel ma tuża Grastofil”.
English: • increase in white blood cells (leukocytosis)
Maltese: • żieda fiċ-ċelluli tad-demm bojod (lewkoċitożi)
English: Grastofil for PBPC mobilisation after myelosuppressive chemotherapy
Maltese: Pressjoni għolja Pressjoni baxxa
English: The long-term safety of administration of Grastofil at doses above 2.4 MU/kg/day (24 micrograms/kg/day) in patients with SCN has not been established.
Maltese: MU/kg/jum (24 mikrogramma/kg/jum) f'pazjenti b'SCN ma ġietx stabbilita.
English: In randomised clinical studies, a subcutaneous dose of 230 micrograms/m2/day (4.0 to 8.4 micrograms/kg/day) was used.
Maltese: (4.0 sa 8.4 mikrogramma/kg/jum).
English: • you have any of the following or a combination of the following side effects: o swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Maltese: • għandek kwalunkwe effett sekondarju minn dawn li ġejjin jew kombinazzjoni tagħhom: o nefħa, li tista' tkun assoċjata ma' li tgħaddi l-ilma b'mod inqas frekwenti, diffikultà fitteħid tan-nifs, nefħa addominali u sensazzjoni ta' li tħossok mimli/ja, sensazzjoni ġenerali ta' għeja.
English: • you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Maltese: • ikollok sogħla, deni u diffikultà biex tieħu n-nifs (dispneja) għax dan jista' jkun sinjal ta' Sindrome ta' Problemi Respiratorji
English: Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-Fluorouracil indicates that the severity of neutropenia may be exacerbated.
Maltese: Evidenza preliminari minn numru żgħir ta' pazjenti li ġew ikkurati fl-istess ħin b'filgrastim u b'5-Fluorouracil tindika li s-severità tan-newtropenija tista' tiħrax.
English: It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
Maltese: Hu rakkomandat li ċentru tal-aferesi jwettaq rekord sistematiku u intraċċar tad-donaturi ta' ċelluli staminali għal mill-inqas 10 snin biex jiżgura l-monitoraġġ tas-sigurtà fuq tul ta' żmien.
English: Grastofil is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of medicines called cytokines.
Maltese: Grastofil hu fattur tat-tkabbir ta' ċelluli tad-demm bojod (fattur li jistimula l-kolonji tal-granuloċiti) u jappartjeni għal grupp ta' mediċini msejħa cytokines.
English: During intermittent dosing with 30 MU (300 microgram)/day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Maltese: Matul id-dożaġġ intermittenti bi 30 MU (300 mikrogramma)/jum ta' filgrastim, jista' jkun hemm fluttwazzjonijiet kbar fl-ANC tal-pazjent malmedda taż-żmien.
English: Grastofil dosing should be maintained until the last leukapheresis.
Maltese: Grastofil ma ġiex ittestjat f'nisa tqal jew li jkunu qed ireddgħu.
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Maltese: Fattur li jistimula l-kolonji ta' granuloċiti jista' jippromwovi t-tkabbir ta' ċelluli majelojdi in vitro u effetti simili jistgħu jiġu osservati fuq xi ċelluli mhux majelojdi in vitro.
English: Erythema
Maltese: Ipoestesija
English: Dose reductions of filgrastim have been noted to slow or stop the progression of splenic enlargement in patients with severe chronic neutropenia, and in 3% of patients a splenectomy was required.
Maltese: Tnaqqis fid-doża ta' filgrastim kien innutat li jnaqqas jew iwaqqaf il-progressjoni tat-tkabbir tal-milsa f'pazjenti b'newtropenija kronika severa, u fi 3% tal-pazjenti kienet meħtieġa tneħħija kirurġika tal-milsa.
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical studies.
Maltese: Interazzjonijiet possibbli ma' fatturi tat-tkabbir ematopoietiċi oħrajn u cytokines, s'issa ma ġewx investigati fl-istudji kliniċi.
English: • upper respiratory tract infection
Maltese: • infjammazzjoni fil-passaġġ respiratorju ta' fuq
English: Among these, two cases of platelets < 50 x 10
Maltese: Fost dawn, żewġ każijiet b'għadd tal-plejtlits ta' < 50 x 10
English: The results of flow cytometric analysis of
Maltese: Sensittività eċċessiva Sensittività eċċessiva għall-mediċina a
English: Established cytotoxic chemotherapy
Maltese: Is-sindrome ta' tnixxija kapillari
English: For PBPC mobilisation in normal donors, Grastofil should be administered at 1.0 MU/kg/day (10 micrograms/kg/day) for 4 - 5 consecutive days.
Maltese: MU/kg/jum (10 mikrogrammi/kg/jum) għal 4-5 ijiem konsekuttivi.
English: Grastofil 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: F'pazjenti li jkunu qed jirċievu l-kimoterapija ċitotossika, żieda temporanja fl-għadd tan-newtrofili tipikament tiġi osservata minn jum sa jumejn wara l-bidu tat-terapija bi Grastofil.
English: The full EPAR for Galvus 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: The active substance in Galvus, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Maltese: Is-sustanza attiva f'Galvus, il-vildagliptin, hija inibitur tad-dipeptidil-peptidażi-4 (DPP-4).
English: Galvus is a medicine that contains the active substance vildagliptin.
Maltese: Galvus huwa mediċina li fiha s-sustanza attiva vildagliptin.
English: In adults, the recommended dose of Galvus is:
Maltese: Fl-adulti, id-doża rakkomandata ta' Galvus hija:
English: This is a summary of the European public assessment report (EPAR) for Galvus.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Galvus.
English: Four studies compared the effects of Galvus, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).
Maltese: Erba' studji qabblu l-effetti ta' Galvus, meħud f'dożi ta' 50 jew 100 mg kuljum għal 24 ġimgħa, ma' dawk tal-plaċebo, meta użat bħala trattament aġġuntiv mat-trattament eżistenti bil-metformina (544 pazjent), bil-pijoglitażonu (tijażolidinedjonu, 463 pazjent), bil-glimepiride (sulfonilurea, 515-il pazjent) jew bl-insulina (296 pazjent).
English: Why has Galvus been approved?
Maltese: Għaliex ġie approvat Galvus?
English: The most common side effect with Galvus (seen in between 1 and 10 patients in 100) is dizziness.
Maltese: L-effett sekondarju l-aktar komuni b'Galvus (li deher f'bejn pazjent 1 u 10 minn kull 100) kien sturdament.
English: What is the risk associated with Galvus?
Maltese: X'inhu r-riskju assoċjat ma' Galvus?
English: The CHMP noted that Galvus was effective as an add-on to metformin, a thiazolidinedione or a sulphonylurea (dual therapy), a sulphonylurea and metformin (triple therapy) or insulin with or without metformin, and concluded that the benefits of the add-on treatment outweigh the risks.
Maltese: Is-CHMP innota li Galvus kien effikaċi bħala trattament aġġuntiv mat-trattament bil-metformina, bittijażolidinedjonu jew bis-sulfonilurea (terapija doppja), bis-sulfonilurea u bil-metformina (terapija tripla) jew bl-insulina bil-metformina jew mingħajrha, u kkonkluda li l-benefiċċji tat-trattament aġġuntiv huma akbar mir-riskji.
English: In patients with moderate or severe kidney problems, the recommended dose is 50 mg once daily.
Maltese: Għal pazjenti bi problemi moderati jew gravi fil-kliewi, id-doża rakkomandata hija 50 mg darba kuljum.
English: Five of these studies looked at the effects of Galvus taken alone in a total of 3,644 patients, comparing it with placebo (a dummy treatment), metformin, rosiglitazone (a thiazolidinedione) or gliclazide (a sulphonylurea).
Maltese: Ħamsa minn dawn l-istudji analizzaw l-effetti ta' Galvus meħud waħdu f'total ta' 3,644 pazjent, u qabbluh ma' plaċebo (trattament finta), mal-metformina, mar-rosiglitażonu (tijażolidinedjonu) jew mal-glikażide (sulfonilurea).
English: What is Galvus?
Maltese: X'inhu Galvus?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Galvus on 26 September 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Galvus valida fl-Unjoni Ewropea kollha fis-26 ta' Settembru 2007.
English: In combination with metformin and glimepiride, 50 mg Galvus taken twice a day reduced HbA1c levels by 1 percentage point, compared with a reduction of 0.3 percentage points in patients taking placebo.
Maltese: Flimkien mal-metformina u l-glimepiride, 50 mg Galvus meħud darbtejn kuljum naqqsu l-livelli ta' HbA1c b'punt perċentwali wieħed, meta mqabbel ma' tnaqqis ta' 0.3 punti perċentwali f'pazjenti li kienu qed jieħdu l-plaċebo.
English: Galvus used on its own was effective at reducing levels of HbA1c, but was less effective than the comparator medicines.
Maltese: Galvus użat waħdu kien iżjed effikaċi fit-tnaqqis tal-livelli tal-HbA1c, iżda inqas effikaċi mill-mediċini kumparattivi.