FrancophonIA/ELRC3.0 huggingface dataset:
English: The elimination of caspofungin from plasma is slow with a clearance of 10-12 ml/min.
Maltese: L-eliminazzjoni ta' caspofungin mill-plażma sseħħ bil-mod bi tneħħija ta' 10-12 ml/min.
English: INSTRUCTIONS FOR USE IN ADULT PATIENTS (70 mg vial)
Maltese: ADULTI (kunjett ta' 70 mg)
English: Stability data have shown that the product can be used within 24 hours when stored at 25°C or less, or within 48 hours when the intravenous infusion bag (bottle) is stored refrigerated (2 to 8°C) and diluted with sodium chloride solution 9 mg/ml (0.9 %), 4.5 mg/ml (0.45 %), or 2.25 mg/ml (0.225 %) for infusion, or lactated Ringer's solution.
Maltese: Informazzjoni dwar listabilità wriet li l-prodott jista' jintuża fi żmien 24 siegħa meta jinħażen f'temperatura ta' 25°C jew inqas, jew fi żmien 48 siegħa meta l-borża (flixkun) tal-infużjoni fil-vini tinħażen fi friġġ (2 sa 8°C) u tkun dilwita b'soluzzjoni ta' klorur tas-sodju 9 mg/ml (0.9 %), 4.5 mg/ml (0.45 %), jew 2.25 mg/ml (0.225 %) għal infużjoni, jew soluzzjoni lactated ta' Ringer.
English: Cancidas may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Maltese: Serji ta' Taħt il-Ġilda bħas-Sindrome ta' Stevens-Johnson (SJS) u nekrolożi epidermali tossika (TEN).
English: 50 mg VIAL: PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
Maltese: KUNJETT TA' 50 mg: PREPARAZZJONI TAS-SOLUZZJONI GĦAL INFUŻJONI FL
English: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands or
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, L-Olanda jew
English: CANCIDAS 70 mg powder for concentrate for solution for infusion 10 ml Type I glass vial with a grey butyl stopper and a plastic cap with an orange aluminium band.
Maltese: CANCIDAS 70 mg trab għal konċentrat għal soluzzjoni għal infużjoni Kunjett tal-ħġieġ tat-Tip I ta' 10 ml b'tapp griż tal-butyl u għatu tal-plastik b'faxxa oranġjo talaluminju.
English: • The other ingredients are sucrose, mannitol, glacial acetic acid and sodium hydroxide (please see section 2.
Maltese: • Is-sustanzi l-oħra huma: sucrose, mannitol, glacial acetic acid, u sodium hydroxide (jekk jogħġbok ara sezzjoni 2.
English: Similarly, C. parapsilosis isolates intermediate to anidulafungin and micafungin can be regarded intermediate to caspofungin.
Maltese: B'mod simili, iżolati ta' C. parapsilosis intermedji għal anidulafungin u micafungin jistgħu jitqiesu bħala intermedji għal caspofungin.
English: Investigations blood potassium decreased, blood albumin decreased blood creatinine increased, red blood cells urine positive, protein total decreased, protein urine present, prothrombin time prolonged, prothrombin time shortened, blood sodium decreased, blood sodium increased, blood calcium decreased, blood calcium increased, blood chloride decreased, blood glucose increased, blood magnesium decreased, blood phosphorus decreased, blood phosphorus increased, blood urea increased, activated partial thromboplastin time prolonged, blood bicarbonate decreased, blood chloride increased, blood potassium increased, blood pressure increased, blood uric acid decreased, blood urine present, breath sounds abnormal, carbon dioxide decreased, immunosuppressant drug level increased, international normalised ratio increased, urinary casts, white blood cells urine positive, and pH urine increased.
Maltese: Investigazzjonijiet tnaqqis talpotassju fiddemm, tnaqqis tal-albumina fiddemm żieda tal-kreatinina fid-demm, preżenza ta' ċelloli ħomor tad-demm fl-awrina, tnaqqis fit-total ta' proteini, preżenza tal-proteini fl-awrina, żieda fil-ħin ta' prothrombin, tnaqqis fil-ħin ta' prothrombin, tnaqqis tas-sodju fiddemm, żieda tas-sodju fid-demm, tnaqqis tal-kalċju fid-demm, żieda talkalċju fid-demm, tnaqqis tal-chloride fid-demm, żieda tal-glukożju fiddemm, tnaqqis tal-manjeżju fid-demm, tnaqqis tal-fosfru fid-demm, żieda talfosfru fid-demm, żieda tal-urea fiddemm, ħin ta' thromboplastin parzjali attivat imtawwal, tnaqqis tal-bikarbunat tad-demm, żieda tal-chloride fid-demm, żieda tal-potassju fid-demm, żieda filpressjoni tad-demm, tnaqqis tal-uric acid fid-demm, demm fl-awrina preżenti, ħsejjes mhux normali mannifs, tnaqqis fil-carbon dioxide, żieda fil-livell ta' mediċina immunosuppressanti, żieda filproporzjon normalizzat internazzjonali, casts tal-awrina, żieda fiċ-ċelloli bojod tad-demm, u żieda fil-pH tal-awrina.
English: Glacial acetic acid Sodium hydroxide (to adjust the pH)
Maltese: Sodium hydroxide (biex jaġġusta l-pH)
English: INSTRUCTIONS FOR USE IN ADULT PATIENTS (50 mg vial)
Maltese: ADULTI (kunjett ta' 50 mg)
English: CANCIDAS 50 mg powder for concentrate for solution for infusion Each vial contains 50 mg caspofungin (as acetate).
Maltese: U KWANTITATTIVA CANCIDAS 50 mg trab għal konċentrat għal soluzzjoni għal infużjoni Kull kunjett fih 50 mg caspofungin (bħala aċetat).
English: Metabolism and nutrition disorders hypokalemia fluid overload, hypomagnesaemia, anorexia, electrolyte imbalance, hyperglycaemia, hypocalcaemia, metabolic acidosis
Maltese: Disturbi filmetaboliżmu u n nutrizzjoni ipokalemija ammont żejjed ta' fluwidu, ipomanjeżamija, anoreksja, żbilanċ flelettroliti, ipergliċemija, ipokalċemija, aċidożi metabolika
English: When caspofungin is co-administered to paediatric patients (12 months to 17 years of age) with inducers of drug clearance, such as rifampicin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a caspofungin dose of 70-mg/m2 daily (not to exceed an actual daily dose of 70 mg) should be considered.
Maltese: Meta caspofungin jingħata lil pazjenti pedjatriċi (12-il xahar sa 17-il sena) fl-istess ħin ma' indutturi tat-tneħħija tal-mediċina, bħal rifampicin, efavirenz, nevirapine, phenytoin, dexamethasone, jew carbamazepine, għandha tiġi kkunsidrata doża ta' caspofungin ta' 70-mg/m2 kuljum (li m'għandhiex taqbeż doża attwali ta' 70 mg kuljum).
English: The concentrations of the reconstituted vials will be: 7.2 mg/ml.
Maltese: Il-konċentrazzjoni tal-kunjetti rikostitwiti se tkun 7.2 mg/ml.
English: cholestasis, hepatomegaly, hyperbilirubinaemia, jaundice, hepatic function abnormal, hepatotoxicity, liver disorder, gamma-glutamyltransferase increased
Maltese: kolestażi, epatomegalija, iperbilirubinemija, suffejra, funzjoni tal-fwied anormali, tossiċità tal-fwied, disturbi fil-fwied, żieda fil-gammaglutamyltransferase
English: In neonates and infants (<3 months) receiving caspofungin at 25 mg/m2 daily (corresponding mean daily dose of 2.1 mg/kg), caspofungin peak concentration (C1 hr) and caspofungin trough concentration (C24 hr) after multiple doses were comparable to that seen in adults receiving caspofungin at 50 mg daily.
Maltese: Fi trabi għadhom jitwieldu u trabi żgħar (<3 xhur) li rċevew caspofungin f'doża ta' 25 mg/m2 kuljum (doża medja korrispondenti ta' 2.1 mg/kg kuljum), l-akbar konċentrazzjoni ta' caspofungin fil-plażma (C1 hr) u l-inqas konċentrazzjoni ta' caspofungin fil-plażma (C24 hr) wara dożi multipli kienu komparabbli ma' dawk li dehru f'persuni adulti li rċevew caspofungin f'doża ta' 50 mg kuljum.
English: Renal and urinary disorders renal failure, renal failure acute
Maltese: Disturbi fil kliewi u fissistema urinarja indeboliment tal-kliewi, indeboliment akut tal-kliewi
English: This belongs to a group of medicines called antifungals.
Maltese: Din tagħmel parti minn grupp ta' mediċini msejħa antifungali.
English: General disorders and administration site conditions pyrexia, chills, infusion-site pruritus pain, catheter site pain, fatigue, feeling cold, feeling hot, infusion site erythema, infusion site induration, infusion site pain, infusion site swelling, injection site phlebitis, oedema peripheral, tenderness, chest discomfort, chest pain, face oedema, feeling of body temperature change, induration, infusion site extravasation,
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata deni, tkexkix ta' bard, ħakk fis-sit tal-infużjoni uġigħ, uġigħ fis-sit tal-katiter, għeja, bard, sħana, eritema fis-sit ta' infużjoni, twebbis tas-sit ta' infużjoni, uġigħ fissit ta' infużjoni, flebite fis-sit talinjezzjoni, edema periferali, sensittività, skumdità fis-sider, uġigħ fis-sider, edema fil-wiċċ, ħass ta' bidla fittemperatura tal-ġisem, twebbis, ekstravażazzjoni fis-sit ta' infużjoni, irritazzjoni tas-sit ta' infużjoni, flebite tas-sit ta' infużjoni, raxx fis-sit ta' infużjoni, urtikarja fis-sit ta' infużjoni, eritema tas-sit ta' injezzjoni, edema fissit ta' injezzjoni, uġigħ fis-sit ta' injezzjoni, nefħa fis-sit ta' injezzjoni, telqa, edema
English: Two hundred twenty-four patients were included in the primary efficacy analysis (MITT analysis) of response at the end of IV study therapy; favourable response rates for the treatment of invasive candidiasis were comparable for caspofungin (73 % [80/109]) and amphotericin B (62 % [71/115]) [% difference 12.7 (95.6 % CI -0.7, 26.0)].
Maltese: Mitejn u erbgħa u għoxrin pazjent kienu inklużi fl-analiżi primarja tal-effikaċja (analiżi MITT) tar-rispons fit-tmiem tatterapija ta' studju fil-vini; ir-rati ta' rispons favorevoli għat-trattament ta' kandidjasi invażiva kienu komparabbli għal caspofungin (73 % [80/109]) u amphotericin B (62 % [71/115]) [% differenza 12.7
English: Reduced volume infusions in 100 ml may be used, when medically necessary, for 50 mg or 35 mg daily doses.
Maltese: Meta jkun medikament meħtieġ, jistgħu jintużaw infużjonijiet ta' volum imnaqqas f'100 ml, għad-dożi ta' 50 mg jew 35 mg kuljum.
English: c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection.
Maltese: Ittrasferixxi b'mod asettiku dan il-volum (ml)c ta' CANCIDAS rikostitwit għal borża (jew flixkun) IV li fiha 250 ml ta' 0.9%, 0.45 %, jew 0.225 % Injezzjoni ta' Klorur tas-Sodju, jew Injezzjoni Lactated ta' Ringers.
English: Renal impairment No dosage adjustment is necessary based on renal impairment (see section 5.2).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża minħabba indeboliment tal-kliewi (ara sezzjoni 5.2).
English: EU/1/01/196/001 EU/1/01/196/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/01/196/003
English: Due to poor enrolment, the study was terminated early and only 51 patients were randomized.
Maltese: Minħabba reġistrazzjoni batuta, l-istudju ntemm qabel u 51 pazjent biss ġew randomizzati.
English: Pregnancy
Maltese: ADULTI
English: c CANCIDAS is formulated to provide the full labelled vial dose (50 mg) when 10 ml is withdrawn from the vial.
Maltese: ċ CANCIDAS huwa fformulat sabiex jipprovdi d-doża ttikkettjata kollha tal-kunjett (50 mg) meta jinġibdu 10 ml mill-kunjett.
English: Cancidas 50 mg powder for concentrate for solution for infusion Each vial of Cancidas contains 50 mg of caspofungin.
Maltese: Cancidas 50 mg trab għal konċentrat għal soluzzjoni għal infużjoni Kull kunjett ta' Cancidas fih 50 mg ta' caspofungin.
English: To reconstitute the powder bring the vial to room temperature and aseptically add 10.5 ml of water for injection.
Maltese: Ġib il-kunjett imkessaħ ta' CANCIDAS għat-temperatura tal-kamra B'mod asettiku żid 10.5 ml ta' ilma għall-injezzjoni.
English: Cancidas 70 mg powder for concentrate for solution for infusion Each vial of Cancidas contains 70 mg of caspofungin.
Maltese: Cancidas 70 mg trab għal konċentrat għal soluzzjoni għal infużjoni Kull kunjett ta' Cancidas fih 70 mg ta' caspofungin.
English: c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/ml.
Maltese: B'mod alternattiv, il-volum (ml)c ta' CANCIDAS rikostitwit jista' jiġi miżjud ma' volum imnaqqas ta' 0.9 %, 0.45 %, jew 0.225 % Injezzjoni ta' Klorur tasSodju jew Injezzjoni Lactated ta' Ringers, li m'għandhiex taqbeż konċentrazzjoni finali ta' 0.5 mg/ml.
English: There were 1,095 patients included in the primary Modified Intention-To-Treat (MITT) efficacy analysis of overall favourable response; caspofungin (33.9 %) was as effective as liposomal amphotericin B (33.7 %) [% difference 0.2 (95.2 % CI -5.6, 6.0)].
Maltese: Kien hemm 1095 pazjent inklużi fl-analiżi primarja tal-effikaċja Modified Intention-To-Treat (MITT) tar-rispons favorevoli globali; caspofungin (33.9 %) kien effettiv daqs amphotericin B
English: Skin and subcutaneous tissue disorders rash, pruritus, erythema, hyperhidrosis erythema multiforme, rash macular, rash maculo-papular, rash pruritic, urticaria, dermatitis allergic, pruritus generalised, rash erythematous, rash generalised, rash morbilliform, skin lesion
Maltese: Nekrolożi epidermali ġilda iperidrożi urtikarja, dermatite allerġika, ħakk ġeneralizzat, raxx eritematuż, raxx ġeneralizzat, raxx morbilliforme, leżjoni fil-ġilda tossika u syndrome ta' Stevens-Johnson syndrome (ara sezzjoni 4.4)
English: CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion
Maltese: Cancidas 50 mg trab għal konċentrat għal soluzzjoni għal infużjoni Cancidas 70 mg trab għal konċentrat għal soluzzjoni għal infużjoni
English: CANCIDAS 70 mg powder for concentrate for solution for infusion Each vial contains 70 mg caspofungin (as acetate).
Maltese: CANCIDAS 70 mg trab għal konċentrat għal soluzzjoni għal infużjoni Kull kunjett fih 70 mg caspofungin (bħala aċetat).
English: Powder for concentrate for solution for infusion.
Maltese: Trab għal konċentrat għal soluzzjoni għal infużjoni.
English: Paediatric Patients: In adolescents (ages 12 to 17 years) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24 hr was generally comparable to that seen in adults receiving caspofungin at 50 mg daily.
Maltese: Fl-adoloxxenti (etajiet minn 12 sa 17-il sena) li rċevew caspofungin f'doża ta' 50 mg/m2 kuljum (massimu 70 mg kuljum), l-AUC0-24hr ta' caspofungin fil-plażma kienet ġeneralment komparabbli ma' dik li dehret f'persuni adulti li rċevew caspofungin f'doża ta' 50 mg kuljum.
English: Psychiatric disorders anxiety, disorientation, insomnia
Maltese: Disturbi psikjatriċi ansjetà, diżorjentament, diffikultà flirqad
English: 35 mg for moderate hepatic impairment (from one 70 mg vial)
Maltese: 35 mg għal indeboliment moderat tal-fwied (minn kunjett wieħed ta' 70 mg)
English: Uncommon: may affect up to 1 in 100 people:
Maltese: Mhux komuni: jistgħu jaffettwaw sa persuna waħda minn kull 100:
English: CANCIDAS 50 mg powder for concentrate for solution for infusion Caspofungin
Maltese: TAL-PRODOTT MEDIĊINALI CANCIDAS 50 mg trab għal konċentrat għal soluzzjoni għal infużjoni Caspofungin
English: In children (ages 2 to 11 years) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24 hr after multiple doses was comparable to that seen in adults receiving caspofungin at 50 mg/day.
Maltese: Fit-tfal (etajiet minn 2 sa 11-il sena) li rċevew caspofungin f'doża ta' 50 mg/m2 kuljum (massimu 70 mg kuljum), l-AUC0-24hr ta' caspofungin fil-plażma wara dożi multipli kienet komparabbli ma' dik li dehret f'persuni adulti li rċevew caspofungin f'doża ta' 50 mg/kuljum.
English: How to store Cancidas
Maltese: X'inhu Cancidas
English: What you need to know before you are given Cancidas).
Maltese: X'għandek tkun taf qabel ma tingħata Cancidas).
English: Method of administration
Maltese: Preparazzjoni standard
English: CANCIDAS 50 mg powder for concentrate for solution for infusion
Maltese: CANCIDAS 50 mg trab għal konċentrat għal soluzzjoni għal infużjoni
English: Gastrointestinal disorders nausea, diarrhoea, vomiting abdominal pain, abdominal pain upper, dry mouth, dyspepsia, stomach discomfort, abdominal distension, ascites, constipation, dysphagia, flatulence
Maltese: Disturbi gastro intestinali dardir, dijarea, rimettar uġigħ addominali, uġigħ addominali filparti ta' fuq, ħalq xott, dispepsja, skumdità fl-istonku, distensjoni addominali, axxite, stitikezza, disfaġja, gass
English: CANCIDAS 70 mg powder for concentrate for solution for infusion Caspofungin
Maltese: TAL-PRODOTT MEDIĊINALI CANCIDAS 70 mg trab għal konċentrat għal soluzzjoni għal infużjoni Caspofungin
English: For caspofungin, there were no effects on fertility in studies conducted in male and female rats up to 5 mg/kg/day.
Maltese: Għal caspofungin, ma kienx hemm effetti fuq il-fertilità fi studji li saru fuq firien rġiel u nisa sa 5 mg/kg/jum.
English: Calculation of Body Surface Area (BSA) for paediatric dosing Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller3 Formula)
Maltese: Kalkulazzjoni tal-Arja tas-Superfiċje tal-Ġisem (BSA) għal dożaġġ pedjatriku Qabel ma tipprepara l-infużjoni, ikkalkula l-arja tas-superfiċje tal-ġisem (BSA) tal-pazjent billi tuża din il-formula: (Formula Mosteller3)
English: Cancidas is used to treat the following infections in children, adolescents and adults:
Maltese: Asperġillożi Invażiva f'Pazjenti Adulti:
English: infusion site irritation, infusion site phlebitis, infusion site rash, infusion site urticaria, injection site erythema, injection site oedema, injection site pain, injection site swelling, malaise, oedema
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras sturdament, disgweżja, paraesteżija, ħedla ta' rqad, rogħda, ipoestesija
English: Class
Maltese: CANCIDAS
English: In young children and toddlers (ages 12 to 23 months) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24 hr after multiple doses was comparable to that seen in adults receiving caspofungin at 50 mg daily and to that in older children (2 to 11 years of age) receiving the 50 mg/m2 daily dose.
Maltese: Fit-tfal żgħar u t-trabi li għadhom kemm telqu jimxu (etajiet minn 12 sa 23 xahar) li rċevew caspofungin f'doża ta' 50 mg/m2 kuljum (massimu 70 mg kuljum), l-AUC0-24hr ta' caspofungin filplażma wara dożi multipli kienet komparabbli ma' dik li dehret f'persuni adulti li rċevew caspofungin f'doża ta' 50 mg kuljum u ma' dik fi tfal akbar (etajiet minn 2 sa 11-il sena) li rċevew id-doża ta' 50 mg/m2 kuljum.
English: c. CANCIDAS is formulated to provide the full labelled vial dose (70 mg) when 10 ml is withdrawn from the vial.
Maltese: ċ CANCIDAS huwa fformulat sabiex jipprovdi d-doża ttikkettjata kollha tal-kunjett (70 mg) meta jinġibdu 10 ml mill-kunjett.
English: oesophageal candidiasis, and invasive aspergillosis (as salvage therapy).
Maltese: Cancidas jintuża biex jikkura l-infezzjonijiet li ġejjin fit-tfal, fl-adoloxxenti u fl-adulti:
English: The second study was a prospective, open-label, non-comparative study estimating the safety and efficacy of caspofungin in paediatric patients (ages 6 months to 17 years) with invasive candidiasis,
Maltese: It-tieni studju kien studju prospettiv, open-label, mhux komparattiv li kkalkula s-sigurtà u l-effikaċja ta' caspofungin f'pazjenti pedjatriċi (6 xhur sa 17-il sena) b'kandidjasi invażiva, kandidjasi esofagali, u asperġillożi invażiva (bħala terapija ta' salvataġġ).
English: CANCIDAS 50 mg powder for concentrate for solution for infusion 10 ml Type I glass vial with a grey butyl stopper and a plastic cap with a red aluminium band.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih CANCIDAS 50 mg trab għal konċentrat għal soluzzjoni għal infużjoni Kunjett tal-ħġieġ tat-Tip I ta' 10 ml b'tapp griż tal-butyl u għatu tal-plastik b'faxxa ħamra talaluminju.
English: Preparation of the 70 mg/m infusion for paediatric patients >3 months of age (using a 70-mg vial) Determine the actual loading dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation:
Maltese: Preparazzjoni tal-infużjoni ta' 70 mg/m2 għal pazjenti pedjatriċi minn 3 xhur 'il fuq (billi jintuża kunjett ta' 50 mg) Stabbilixxi l-loading dose attwali li għandha tintuża fil-pazjent pedjatriku billi tuża l-BSA talpazjent (kif ikkalkulata hawn fuq) u l-ekwazzjoni segwenti:
English: CANCIDAS 70 mg powder for concentrate for solution for infusion
Maltese: CANCIDAS 70 mg trab għal konċentrat għal soluzzjoni għal infużjoni
English: Oral use blister (alu/alu)
Maltese: Pillola miksija b'rita Użu orali folja (alu/alu)
English: Film-coated tablet
Maltese: Il-pakkett li jmiss malprodott
English: The full EPAR for Imatinib Teva 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 capsules (100 and 400 mg) and tablets (100 and 400 mg) and is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Maltese: Jiġi bħala kapsuli (100 u 400 mg) u pilloli (100 u 400 mg) u jingħata oralment mal-ikel u tazza ilma kbira biex jitnaqqas ir-riskju li jkun hemm irritazzjoni fl-istonku u l-musrana.
English: The active substance in Imatinib Teva, imatinib, is a protein-tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Imatinib Teva, l-imatinib, hija inibitur tal-proteina tirosina kinażi.
English: Imatinib Teva is a cancer medicine.
Maltese: Imatinib Teva hija mediċina tal-kanċer.
English: Imatinib Teva contains the active substance imatinib.
Maltese: Imatinib Teva fih is-sustanza attiva imatinib.
English: This is a summary of the European public assessment report (EPAR) for Imatinib Teva.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Imatinib Teva.
English: Imatinib Teva is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Maltese: Imatinib Teva jintuża fil-kura ta' adulti bil-MD/MPD li kellhom arranġamenti mill-ġdid tal-ġene għar-riċettur tal-fattur tat-tkabbir derivat mill-pjastrini (PDGFR);
English: Imatinib Teva is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Maltese: Imatinib Teva jintuża meta l-pazjenti jkunu ‘pożittivi għall-kromożoma ta' Filadelfja' (Ph+).
English: This means that Imatinib Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
Maltese: Dan ifisser li Imatinib Teva huwa simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fl-Unjoni Ewropea (UE) imsejħa Glivec.
English: Because Imatinib Teva is a generic medicine, studies in patients have been limited to tests to determine that the tablets and capsules are bioequivalent to the reference medicine, Glivec.
Maltese: Peress li Imatinib Teva huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testijiet biex jiġi stabbilit jekk il-pilloli u l-kapsuli humiex bijoekwivalenti għall-mediċina ta' referenza, Glivec.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib Teva on 8 January 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Imatinib Teva valida fl-Unjoni Ewropea kollha fit-8 ta' Jannar 2013.
English: • advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
Maltese: • sindromu avvanzat ipereosinofiliku (HES) jew lewkimja kronika eosinofilika (CEL), mard fejn leosinofili (tip ieħor ta' ċelloli bojod fid-demm) jibdew jikbru mingħajr kontroll.
English: Imatinib Teva is used in combination with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Maltese: Imatinib Teva jintuża flimkien ma' mediċini oħra kontra lkanċer f'adulti u tfal li ġew dijanjostikati riċentement bil-Ph+ ALL.
English: • Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
Maltese: • Ph+ lewkimja limfoblastika akuta (ALL), tip ta' kanċer fejn il-linfoċiti (tip ieħor ta' ċelloli bojod taddemm) jirriproduċu ruħhom malajr ħafna.
English: Why is Imatinib Teva approved?
Maltese: Għal xiex ġie approvat Imatinib Teva?
English: This means that it blocks some specific enzymes known as tyrosine kinases.
Maltese: Dan ifisser li din timblokka xi enzimi speċifiċi magħrufa bħala tirosina kinażi.