FrancophonIA/ELRC3.0 huggingface dataset:
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed:
Maltese: Il-fergħa tal-pazjenti li ħadu TAC, imqassam fi gruppi żgħar, skont fatturi pronostiċi maġġuri, definiti prospettivament, kien analiżżat:
English: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%) patients in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Maltese: Wara 10 snin ta' osservazzjoni fl-istudju GEICAM 9805, lewkimja akuta seħħet f'pazjent 1 minn 532 pazjent (0.2 %) fil-fergħa TAC.
English: Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Maltese: Profilassi primarja b'G-CSF għandu jiġi kkonsidrat f'pazjenti li jirċievu terapija adjuvanti b'TAC għal kanċer tas-sider sabiex jimmitiga r-riskju ta' newtropenija kkumplikata (newtropenija bid-deni, newtropenija prolongata jew infezzjoni newtropenika).
English: Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Maltese: Il-pazjenti trattati b'TCF għandhom jingħataw il-profilassi b'G-CSF biex jonqos ir-riskju tan-newtropenija komplikata (newtropenija bid-deni, newtropenija fit-tul jew in-newtropenija assoċjata ma' infezzjoni).
English: In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m² to 75 mg/m² and/or from 75 to 60 mg/m².
Maltese: <500 ċelluli/mm għal aktar minn ġimgħa, jew reazzjonijiet severi jew kumulattivi fil-ġilda, jew newropatija severa u periferika, waqt it-terapija bid-docetaxel, id-doża ta' docetaxel trid titnaqqas minn 100 mg/m² għal 75 mg/m² u/jew minn 75 għal 60 mg/m².
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m² and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Id-doża medjana kumulattiva għall-waqfien tat-trattament kienet aktar minn 1,000 mg/m², u z-żmien medjan għar-riversibbilità taż-żamma tal-fluwidu kien ta' 16.4 ġimghat (medda 0 sa 42 ġimghat).
English: Psychiatric disorders Nervous system disorders Eye disorders Cardiac disorders
Maltese: Disturbi fis-sistema immuni Sensittivita eċċessiva Disturbi fis-sistema nervuża Newropatija periferika
English: Pain in extremity (G3/4: < 1%); Back pain (G3/4: 1%)
Maltese: Disturbi fis-sistema nervuża Disgewżja (G3/4: < 1%); Parasteżija (G3/4: < 1%)
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² single agent:
Maltese: Lista f'tabella tar-reazzjonijiet avversi fil-kanċer tas-sider għal Docetaxel 100 mg/m² bħala sustanza użata waħedha:
English: 60 mg/m².
Maltese: 100 mg/m² għal 75 mg/m² u/jew minn 75 għal 60 mg/m².
English: Asthenia (G3/4: 3%);
Maltese: Letarġija (G3/4:3.4%).
English: Docetaxel Mylan has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, docetaxel could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Maltese: Docetaxel Mylan huwa sustanza kimika għall-użu kontra t-tumuri u, bħal kull sustanza potenzjalment tossika, trid tkun eżerċitata l-kawtela fl-immaniġġar u fil-preparazzjoni tat-taħlitiet ta' Docetaxel.
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Maltese: L-aħjar rizultat sħiħ bit-trattament studjat [kimoterapija +/- radjuterapija] (%) (95%CI) ***valur p
English: Without primary G-CSF prophylaxis
Maltese: Il-frekwenzi huma kif spjegat:
English: Esophagitis/dysphagia/ odynophagia (G3/4:
Maltese: Uġigħ tal-kanċer (G3/4:
English: Thrombocytopenia (G3/4: 0.6%);
Maltese: Emoraġija gastrointestinali (G3/4:0.6%)
English: - For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
Maltese: − Għat-trattament ta' kanċer metastatiku tal-istonku, docetaxel jingħata flimkien ma' cisplatin u 5fluorouracil.
English: Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis;
Maltese: Parasteżija; Ugigħ ta' ras; Disgewżja;
English: Alopecia; Erythema, Rash; Nail disorders
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: Nail disorders (severe: Skin reaction (no severe)
Maltese: Sensittività eċċessiva (mhux severa)
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion docetaxel
Maltese: TAL-PRODOTT MEDIĊINALI Docetaxel Mylan 20 mg/1 mg ta' konċentrat għal soluzzjoni għall-infużjoni. docetaxel
English: Tabulated list of adverse reactions in head and neck cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Maltese: Lista f'tabella ta' reazzjonijiet avversi f'adenokarċinoma tal-istonku għal Docetaxel 75 mg/m² użat flimkien ma' cisplatin u 5-fluorouracil -Sistema tal-klassifika tal-organi fidDatabase MedDRA
English: Data from one multicenter, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Maltese: III, u li sar b'mod każwali b'kontrolli, ssostni l-użu ta' docetaxel flimkien ma' capecitabine għat-trattament ta' pazjenti b'kanċer tas-sider avvanzat lokalment jew dak metastatiku, wara li falliet il-kimoterapija ċitotossika, inkluża anthracycline.
English: • For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1, and then resume treatment with docetaxel 55 mg/m².
Maltese: • Għal pazjenti li titfaċċalhom għat-tieni darba t-tossiċità ta' Grad 2, jew it-tossiċità ta' Grad 3 għall-ewwel darba, f'kwalunkwe ħin waqt iċ-ċiklu tat-trattament , ittardja t-trattament sakemm ittossiċità tinżel għal Grad 0 sa 1 u mbagħad kompli t-trattament b'docetaxel 55 mg/m².
English: Hazard ratio (95% CI) **p-value
Maltese: Il-proporzjon tar-riskju (95%CI) **valur p
English: The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m²) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m²); however, it has been reported in some patients during the early courses of therapy.
Maltese: Il-bidu taż-żamma moderat u sever ittardja (doża kumulattiva medjana: 818.9 mg/m²) f'pazjenti li ħadu l-premedikazzjoni, meta mqabbel ma' dawk li ma ħadux il-premedikazzjoni (doża kumulattiva medjana: 489.7 mg/m²).
English: The median TTP was 37.3 weeks (95% CI: 33.4-42.1) in AT arm and 31.9 weeks (95% CI: 27.4-36.0) in AC arm.
Maltese: • Iż-żmien tal-progressjoni (ŻTP) kien sinifikament itwal fil-fergħa AT kontra l-fergħa AC, p=0.0138. Iż-ŻTP medjan kien 37.3 ġimgħat (95% CI: 34.4-42.1) fil-fergħa AT u 31.9 ġimgħat (95% CI: 27.4-36.0) fil-fergħa AC.
English: Dizziness (G3/4: 2.0%);
Maltese: Tqalligħ (G3/4: 2.4%);
English: Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m² (see sections 4.4 and 5.2).
Maltese: Ibbażat fuq tagħrif farmakokinetiku b'docetaxel f'doża ta' 100 mg/m² meta mogħti waħdu, il-pazjenti li għandhom livelli għoljin tal-enżimi trasaminażi (ALT u/jew AST) aktar minn 1.5 drabi tal-ogħla livell tal-firxa normali (ULN) u l-livell tal-enzima alkaline phosphatase aktar minn 2.5 drabi tal-ULN, id-doża rakkomandata ta' docetaxel hija ta' 75 mg/m² (ara sezzjonijiet 4.4 u 5.2).
English: PSA** response rate (%) 95% CI p-value*
Maltese: Numru ta' pazjenti PSA** ir-rata tar-rispons (%) 95% CI valur p*
English: Vascular disorders Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%) Phlebitis (G3/4: 0%)
Maltese: Pressjoni baxxa (G3/4: Flebite (G3/4:0%)
English: Hazard ratio (95% CI) *p-value
Maltese: Il-proporzjon tar-riskju (95% CI) *valur p
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m² as a 1 hour infusion followed by cisplatin 75 mg/m² over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m² per day for five days.
Maltese: Fit-trattament induttiv ta' kanċer inoperabbli tat-tip ta'ċellula skwamuża tal-ġilda, li huwa lokalment avvanzat, fir-ras u fl-għonq (SCCHN), id-doża rakkomandata ta' docetaxel hija 75 mg/m² bħala infużjoni fuq tul ta' siegħa, segwita minn cisplatin 75 mg/m² f'tul ta' aktar minn siegħa, fl-ewwel jum, segwit minn 5-fluorouracil bħala infużjoni mingħajr waqfien ta' 750 mg/m² kuljum għal ħamest ijiem.
English: Fatigue/weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Maltese: Stomatite/Farinġite (G3/4: 0.9%); Rimettar (G3/4: 1.2%)
English: At the end of the follow-up period (actual median follow-up time of 96 months), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Maltese: Fit-tmiem tal-perijodu ta' osservazzjoni ta' wara t-trattament (medjan proprju taż-żmien ta' osservazzjoni ta' wara t-trattament ta' 96 xahar), l-alopeċja kienet għadha hemm f'29 pazjent fuq TAC (3.9 %) u f'16-il pazjent fuq FAC (2.2%).
English: The second interim analysis was done after 400 DFS events had been recorded overall, which led to a median follow-up of 55 months.
Maltese: It-tieni analiżi interim sar wara 400 każ DFS ġie reġistrat globalment, li wassal għal follow-up medjan ta' 55 xahar.
English: Thrombocytopenia (G4: 1.7%)
Maltese: Newtropenija (G4: 91.7%);
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, and who previously had not received chemotherapy for metastatic disease.
Maltese: Docetaxel użat flimkien ma' trastuzumab kien studjat fit-trattament ta' pazjenti b'kanċer metastatiku tassider, liema tumuri kienu jipproduċu HER 2, u li precedentement ma rċevewx il-kimoterapija għal mard metastatiku.
English: Alopecia (G3/4:
Maltese: Tqalligħ (G3/4:
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m in combination with cisplatin and 5-fluorouracil
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula f'adenokarċinoma gastrika għal Docetaxel 75 mg/m2
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/001 - 1 vial
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/748/001 - kunjett 1
English: - Keep this leaflet.
Maltese: Sottosett ta' pazjenti
English: Constipation (G3/4: 1%); Abdominal pain (G3/4: 2%); Dyspepsia
Maltese: Dispepsja (G3/4: 0.8%); Ugigħ gastro-intestinali (G3/4: 1.2%); Emoraġija gastrointestinali (G3/4:
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Docetaxel Mylan 20 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni
English: In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
Maltese: Fl-istudji ewlenien SCCHN, il-pazjenti li kellhom newtropenija b'komplikazzjonijiet (li jinkludu newtropenija fit-tul, newtropenija bid-deni, jew infezzjoni), kien rakkomandat l-użu ta' G-CSF biex jipprovdi protezzjoni profilattika (eż. is-6 jum sal-15) fiċ-ċikli sussegwenti kollha.
English: Data from a multicenter open label randomized study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Maltese: Id-data mill-istudju ta' ċentri multipli, fejn kemm il-pazjenti kif ukoll l-investigaturi kienu jafu x'mediċini qed jintużaw, u l-pazjenti tqassmu mingħajr għażla, isaħħu l-użu ta' docetaxel għattrattament miżjud f'pazjenti li għandhom kanċer tas-sider li nfirex fil-glandoli limfatiċi u li huwa operabbli b'KPS ta' ≥80%, minn 18 sa 70 sena fl-età.
English: For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1).
Maltese: Għal pazjenti b'kanċer operabbli negattiv għal glandoli tas-sider, trattament adjuvanti għandu jiġi ristrett għal pazjenti eleġibbli biex jirċievu kimoterapija skont il-kriterji stabbiliti internazzjonalment għal terapija prinċipali għal kanċer tas-sider bikri (ara sezzjoni 5.1).
English: Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m2 in all subsequent cycles (see sections 4.4 and 4.8).
Maltese: Pazjenti li kellhom newtropenja biddeni u/jew infezzjoni newtropenika għandu jkollhom id-doża tagħhom ta' docetaxel imnaqqsa għal 60 mg/m² f'kull ċiklu sussegwenti (ara sezzjonijiet 4.4 u 4.8).
English: Hazard ratio: (95% CI) *p-value
Maltese: Il-proporzjon tar-riskju (95%CI) *valur p
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 9% reduction in the risk of death compared to FAC-treated patients (hazard ratio = 0.91, 95% CI (0.63-1.32)).
Maltese: Fil-medjan taż-żmien ta' ossevazzjoni ta' 10 snin u 5 xhur, pazjenti kkurati b'TAC kellhom tnaqqis ta' 9% fir-riskju ta' mewt meta mqabbla ma' pazjenti kkurati b' FAC (proporzjon ta' periklu = 0.91, 95% CI (0.
English: Oedema
Maltese: jingħata
English: Thrombocytopenia (G4:
Maltese: Uġigh tal-kanċer (G3/4:
English: • fungal infection of the mouth (oral candidiasis)
Maltese: • infezzjoni bil-moffa fil-ħalq (kandidijasi orali)
English: Tell them immediately if you notice any of these effects.
Maltese: Id-data ta' skadenza tirreferi għall-aħħar jum ta' dak ix-xahar.
English: In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m² every three weeks, combined with capecitabine at 1250 mg/m² twice daily (within 30 minutes after a meal) for 2 weeks followed by 1-week rest period.
Maltese: Flimkien ma' capecitabine, id-doża rakkomandata ta' docetaxel hija 75 mg/m² kull tliet ġimgħat, flimkien ma' capecitabine 1250 mg/m² darbtejn kuljum (fi żmien ta' 30 minuta wara l-ikel ) għal ġimagħatejn, segwit b'perijodu ta' waqfien għal ġimgħa.
English: • blurred vision due to swelling of the retina within the eye (cystoid macular oedema) • decrease of the sodium in your blood.
Maltese: • vista mċajpra minħabba nefħa tar-retina ġewwa l-għajn (edima makulari ċistojde)
English: Arrhythmia (G3/4: 0.7%)
Maltese: Infezzjoni (G3/4: 7.8%)
English: Patients in both treatment arms were to receive 7 weeks of CRT following induction chemotherapy with a minimum interval of 3 weeks and no later than 8 weeks after start of the last cycle (day 22 to day 56 of last cycle).
Maltese: Pazjenti fi zewġ friegħi tat-trattament ingħataw CRT għal 7 ġimgħat wara l-kimoterapija induttiva, b'intervall minimu ta' 3 ġimgħat u mhux aktar tard minn 8 ġimgħat mill-bidu tal-aħħar ċiklu (jum 22 sa jum 56 tal-aħħar ċiklu).
English: Dyspnoea (severe: 2.7%)
Maltese: Astenja (severa: 11.2%); Uġigħ
English: • Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Maltese: III magħmul minn ċentri multipli, fejn kemm l-investigatur kif ukoll il-pazjent kienu jafu x'mediċini qed jintużaw, u fejn il-pazjenti tqassmu b'mod każwali (TAX323).
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Docetaxel Mylan 200 mg/10 ml konċentrat għal soluzzjoni għall-infużjoni
English: EU (MA) Number Invented name
Maltese: Numru ta' l-EU (MA)
English: Route of administration
Maltese: Mod ta' Amministraz zjoni
English: The full EPAR for Protaphane is available ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Protaphane huwa disponibbli fuq ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The active substance in Protaphane, human insulin, is produced by a method known as ‘recombinant technology': it is made by yeast cells into which a gene (DNA) has been introduced which makes them able to produce insulin.
Maltese: Is-sustanza attiva f'Protaphane, l-insulina umana, hi prodotta b'metodu magħruf bħala ‘teknoloġija rekombinanti': dan isir minn ċelloli tal-ħmira li fihom tkun ġiet introdotta ġene (DNA) li tagħmilhom kapaċi jipproduċu l-insulina.
English: Protaphane is a suspension for injection that contains the active substance human insulin.
Maltese: Protaphane huwa sospensjoni għall-injezzjoni li fiha s-sustanza attiva insulina umana.
English: Protaphane has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Maltese: Protaphane ġie studjat f'erba' provi kliniċi ewlenin, li inkludew total ta' 557 pazjent bid-dijabete tat-tip 1, li fiha l-frixa ma tkunx tista' tipproduċi insulina (żewġ studji li involvew 81 pazjent), jew dijabete tattip 2, meta l-ġisem ma jkunx jista' juża l-insulina b'mod effikaċi (żewġ studji li involvew 476 pazjent).
English: This is a summary of the European public assessment report (EPAR) for Protaphane.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Protaphane.
English: Protaphane is a long-acting insulin.
Maltese: Protaphane hu insulina li taħdem fit-tul.
English: Protaphane is given by injection under the skin, usually in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Maltese: Protaphane jingħata bħala injezzjoni taħt il-ġilda, normalment fil-koxxa, fil-ħajt tal-addome (fil-parti ta' quddiem tal-qadd), fil-parti tal-glutei (il-warrani), jew fil-parti deltojde (l-ispalla).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Protaphane on 7 October 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Protaphane valida fl-Unjoni Ewropea kollha fis-7 ta' Ottubru 2002.
English: It is available as vials, cartridges (Penfill), or pre-filled pens (InnoLet or FlexPen).
Maltese: Jiġi fi vjali, stoċċijiet (Penfill), jew pinen mimlija minn qabel (InnoLet jew FlexPen).
English: Protaphane is a replacement insulin which is very similar to the insulin made by the pancreas.
Maltese: Protaphane huwa insulina ta' sostituzzjoni simili ħafna għall-insulina prodotta mill-frixa.
English: Protaphane contains insulin mixed with another substance, protamine, in an ‘isophane' form which is absorbed much more slowly during the day.
Maltese: Protaphane fih insulina mħallta ma' sustanza oħra, il-protamina, f'forma ‘isophane' li hija assorbita ħafna aktar bil-mod matul il-jum.
English: How has Protaphane been studied?
Maltese: Kif ġie studjat Protaphane?
English: A risk management plan has been developed to ensure that Protaphane is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Protaphane jintuża bl-aktar mod sigur possibbli.
English: Why has Protaphane been approved?
Maltese: Għaliex ġie approvat Protaphane?
English: The studies measured the level of fasting blood glucose or glycosylated haemoglobin (HbA1c, the haemoglobin in the blood that has glucose attached).
Maltese: L-istudji kejlu l-livell tal-glukożju tad-demm waqt sawm jew l-emoglobina glikosilatata (HbA1c, l-emoglobina fid-demm li għandha l-glukożju magħha).
English: Protaphane led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Maltese: Protaphane wassal għal tnaqqis fil-livell ta' HbA1c, u b'hekk indika li l-livelli taz-zokkor fid-demm kienu ġew ikkontrollati għal livell simili bħal dak b'insulina umana oħra.
English: What is Protaphane?
Maltese: X'inhu Protaphane?
English: In most patients, Protaphane was compared with other types of human insulin or insulin analogues.
Maltese: Fil-biċċa l-kbira tal-pazjenti, Protaphane tqabbel ma' tipi oħrajn ta' insulina umana jew ma' analogi talinsulina.
English: The most common side effect with Protaphane (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Maltese: L-effett sekondarju l-aktar komuni bi Protaphane (li deher f'iktar minn pazjent 1 minn kull 10) huwa ipogliċemija (livelli baxxi ta' glukożju fid-demm).
English: Other information about Protaphane
Maltese: Kif jintuża Protaphane?
English: Protaphane was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pre-filled pens.
Maltese: Protaphane kien effettiv għaddijabete kemm tat-tip 1 kif ukoll tat-tip 2, u meta tintuża injezzjoni standard jew waħda mill-pinen mimlija minn qabel.
English: The CHMP decided that Protaphane's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Protaphane huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Protaphane is used to treat diabetes.
Maltese: Protaphane jintuża fil-kura tad-dijabete.
English: How does Protaphane work?
Maltese: Għal xiex jintuża Protaphane?
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Maltese: L-insulina ta' sostituzzjoni taġixxi bl-istess mod bħall-insulina prodotta b'mod naturali u tgħin lill-glukożju jidħol fiċċelloli mid-demm.
English: Capsules, Soft
Maltese: Kapsuli, Rotob
English: Bristol-Myers Squibb S.A. C/Quintanavides, 15, 28050 Madrid, Spain
Maltese: Bristol-Myers Squibb S.A. C/Quintanavides, 15, 28050
English: Bristol-Myers Squibb GmbH & Co. KGaA
Maltese: Bristol-Myers Squibb GmbH & Co.
English: 300 MBq/ml Solution for injection
Maltese: 300 MBq/ml Soluzzjoni għallinjezzjoni
English: Intravenous use vial (glass)
Maltese: Jingħata ġol-vina Kunjett (ħġieġ)
English: - Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, polysorbate 80, triethyl citrate.
Maltese: - Kisja: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, polysorbate 80, triethyl citrate. - Linka tal-istampar: shellac, red, black and yellow iron oxide (E172), u soluzzjoni tal-ammonja, ikkonċentrata.
English: - The other ingredients are: - Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
Maltese: - Qalba: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
English: SOMAC Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Maltese: SOMAC Control hu disponibbli f'folji Alu/Alu bi jew mingħajr cardboard reinforcement.