FrancophonIA/ELRC3.0 huggingface dataset:
English: aCox proportional hazard bStratified by geographic region, HER2/neu status, and prior capecitabine therapy.
Maltese: Il-majelosoppressjoni tiddependi fuq id-doża u tidher primarjament bħala newtropenija (sezzjoni 4.8).
English: Eribulin is weakly bound to plasma proteins.
Maltese: Eribulin jeħel b'mod dgħajjef mal-proteini tal-plażma.
English: Eribulin is eliminated primarily by biliary excretion.
Maltese: Eribulin jiġi eliminat primarjament permezz ta' tneħħija biljari.
English: The patients in this study (n=452) had locally recurrent, inoperable and/or metastatic soft tissue sarcoma of one of two subtypes - leiomyosarcoma or liposarcoma.
Maltese: Il-pazjenti f'dan l-istudju (n=452) kellhom sarkoma tat-tessut artab, lokalment rikorrenti, inoperabbli u/jew metastatika, ta' wieħed minn żewġ sottotipi - leiomijosarkoma jew liposarkoma.
English: A fertility study was not conducted with eribulin, but based on non-clinical findings in repeated-dose studies where testicular toxicity was observed in both rats (hypocellularity of seminiferous epithelium with hypospermia/aspermia) and dogs, male fertility may be compromised by treatment with eribulin.
Maltese: Ma sarx studju dwar il-fertilità b'eribulin, iżda bbażat fuq riżultati mhux kliniċi fi studji dwar doża ripetuta fejn it-tossiċità testikulari kienet osservata kemm fil-firien (ipoċellularità tal-epitelju seminiferuż b'ipospermja/aspermja) kif ukoll fil-klieb, il-fertilità fl-irġiel tista' tiġi kompromessa millkura b'eribulin.
English: Associated Drug Company Ltd. Tel: + 356 22778000
Maltese: Tel: + 356 22778000
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/678/001 1 vial
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/678/001 1 kunjett
English: HALAVEN is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease (see section 5.1).
Maltese: HALAVEN hu indikat għall-kura tal-pazjenti adulti b'liposarkoma li ma tistax titneħħa b'operazzjoni, li jkunu rċivew terapija li kien fiha anthracycline fil-passat (ħlief jekk ma kinitx adattata) għal mard avvanzat jew metastatiku (ara sezzjoni 5.1).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/678/003 1 vial
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/678/003 1 kunjett
English: The most commonly reported adverse reactions related to HALAVEN, are bone marrow suppression manifested as neutropenia, leucopenia, anaemia, thrombocytopenia with associated infections.
Maltese: Ir-reazzjonijiet avversi li kienu rrappurtati b'mod l-aktar komuni relatati ma' HALAVEN, huma soppressjoni tal-mudullun li tidher bħala newtropenija, lewkopenija, anemija, tromboċitopenija b'infezzjonijiet assoċjati.
English: For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħżin wara d-dilwizzjoni tal-prodott mediċinali miftuħ, ara t-taqsima 6.3.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION HALAVEN 0.44 mg/ml injection
Maltese: U MNEJN GĦANDU JINGĦATA HALAVEN 0.44 mg/ml injezzjoni
English: Liposarcoma
Maltese: Sottogrupp talLiposarkoma
English: Interstitial lung disease (0.2%) (G3/4:
Maltese: Mard interstizjali tal-pulmun (0.2%) (G3/4: 0.1%)
English: Dysgeusia Dizziness (9.0%) (G3/4: 0.4%)d
Maltese: Sturdament (9.0%) (G3/4: 0.4%)
English: Neutropenia resulted in discontinuation in < 1% of patients receiving eribulin.
Maltese: In-newtropenija rriżultat fit-twaqqif tal-kura f'< 1% tal-pazjenti li kienu qed jirċievu eribulin.
English: Rash (4.9%) (G3/4:
Maltese: Infjammazzjoni filMukuża (6.4%) (G3/4:
English: This translated into a 2 month improvement in median OS (13.5 months for eribulin treated patients vs. 11.5 months for dacarbazine treated patients).
Maltese: Dan ġie tradott għal titjib ta' xahrejn fl-OS medjan (13.5 xhur għall-pazjenti kkurati b'eribulin kontra 11.5 xhur għallpazjenti kkurati b'dacarbazine).
English: Although data are limited, patients with bilirubin >1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Maltese: Għalkemm id-dejta hi limitata, pazjenti b'bilirubina ta' >1.5 x ULN ukoll ikollhom inċidenza ogħla ta' newtropenija ta' Grad 4 u newtropenija bid-deni.
English: Dose delays during therapy
Maltese: Tnaqqis fid-doża matul it-terapija
English: The neutropenia observed was reversible and not cumulative; the mean time to nadir was 13 days and the mean time to recovery from severe neutropenia (< 0.5 x 109/l) was 8 days.
Maltese: In-newtropenija osservata kienet riversibbli u mhux kumulattiva; il-medja taż-żmien għal-livell minimu kienet ta' 13-il jum, u l-medja taż-żmien għall-irkuprar minn newtropenija severa (< 0.5 x 109/l) kienet ta' 8 ijiem.
English: Patients had previously received up to three prior chemotherapy regimens, including both an anthracycline and a taxane and a maximum of two for advanced disease, with the percentage who had received 0, 1 or 2 prior chemotherapy treatments for metastatic breast cancer being 20.0%, 52.0% or 27.2% respectively.
Maltese: Il-pazjenti fil-passat kienu rċivew sa tliet korsijiet ta' kimoterapija, li kienu jinkludu kemm anthracycline kif ukoll taxane, u massimu ta' tnejn għal mard avvanzat, b'perċentwali li kienu rċivew 0, 1 jew 2 trattamenti bil-kimoterapija fil-passat għal kanċer metastatiku tas-sider li jkunu ta' 20.
English: Effects of eribulin on the pharmacokinetics of other medicines
Maltese: L-effetti ta' eribulin fuq il-farmakokinetika ta' mediċini oħrajn
English: OTHER
Maltese: PROBABBILTÀ
English: Metabolite concentrations represented <0.6% of parent compound, confirming that there are no major human metabolites of eribulin.
Maltese: 6% tal-kompost prinċipali, li jikkonferma li ma kien hemm l-ebda metaboliti umani maġġuri ta' eribulin.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 1.32 mg eribulin in 3 ml
Maltese: Fih 1.32 mg ta' eribulin fi 3 ml
English: The 762 patients in the pivotal Phase 3 EMBRACE study (Study 305) had locally recurrent or metastatic breast cancer, and had previously received at least two and a maximum of five chemotherapy regimens, including an anthracycline and a taxane (unless contraindicated).
Maltese: Is-762 pazjent fl-istudju importanti ħafna ta' Fażi 3, EMBRACE (Studju 305), kellhom kanċer tassider lokalment rikorrenti jew metastatiku, u fil-passat kienu rċivew mill-inqas żewġ korsijiet ta' kimoterapija u massimu ta' ħames korsijiet ta' kimoterapija, li jinkludu anthracycline u taxane (ħlief jekk kontraindikat).
English: Haematuria Proteinuria Renal failure
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: magnesium or calcium in the blood - Inability to sleep, depression, changed sense of taste - Rash, itching, nail problems, dry or red skin - Excessive sweating (including night sweats) - Ringing in the ears - Blood clots in the lungs - Shingles - Swelling of the skin and numbness of the hands and feet
Maltese: bilirubina, phosphates, potassium, magnesium jew kalċju fid-demm - Ma tkunx kapaċi torqod, dipressjoni, tibdil fis-sens tat-togħma - Raxx, ħakk, problemi fid-dwiefer, ġilda xotta jew ħamra - Għaraq eċċessiv (li jinkludi għaraq matul il-lejl) - Tisfir fil-widnejn - Emboli tad-demm fil-pulmun - Ħruq ta' Sant'Antnin - Nefħa tal-ġilda u tmewwit tal-idejn u tas-saqajn
English: In breast cancer patients with pre-existing Grade 1 or 2 peripheral neuropathy the frequency of treatment-emergent Grade 3 peripheral neuropathy was 14%.
Maltese: F'pazjenti b'kanċer tas-sider b'newropatija periferali ta' Grad 1 jew 2 li kienet teżisti qabel, ilfrekwenza ta' newropatija periferali ta' Grad 3 li żviluppat minħabba l-kura kienet 14%.
English: Severe neutropenia may be managed by the use of granulocyte colony-stimulating factor (G-CSF) or equivalent at the physician's discretion in accordance with relevant guidelines (see section 5.1).
Maltese: Newtropenija severa tista' tiġi mmaniġġjata bl-użu ta' fattur li jistimula l-kolonji tal-granuloċiti (granulocyte colony-stimulating factor, G-CSF) jew ekwivalenti fid-diskrezzjoni tat-tabib b'konformità mal-linji gwida rilevanti (ara sezzjoni 5.1).
English: Overall, the safety profiles in the breast cancer and soft tissue sarcoma patient populations were similar.
Maltese: B'mod ġenerali, il-profili tas-sigurtà fil-popolazzjonijiet ta' pazjenti b'kanċer tas-sider u sarkoma tattessut artab, kienu simili.
English: HALAVEN (n=157)
Maltese: (n=157)
English: Rare side effects (may affect up to 1 in 1000 people) are:
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna) huma:
English: Calculation of the individual dose to be administered to a patient must be based on the strength of the ready to use solution that contains 0.44 mg/ml eribulin and the dose recommendation of 1.23 mg/m2.
Maltese: Il-kalkolu taddoża individwali li għandha tingħata lil pazjent trid tiġi bbażata fuq il-qawwa tas-soluzzjoni lesta biex tintuża li fiha 0.44 mg/ml ta' eribulin u r-rakkomandazzjoni tad-doża ta' 1.23 mg/m2.
English: 18% and 13% of eribulin treated patients received G-CSF in the two phase 3 breast cancer studies (Studies 305 and 301, respectively).
Maltese: Newtropenija severa tista' tiġi mmaniġġjata bl-użu ta' G-CSF jew ekwivalenti fid-diskrezzjoni tattabib b'konformità mal-linji gwida rilevanti. 18% u 13% tal-pazjenti kkurati b'eribulin irċivew G-CSF fiż-żewġ studji ta' fażi 3 dwar il-kanċer tas-sider (Studji 305 u 301, rispettivament).
English: In Study 309, a statistically significant improvement in OS was observed in patients randomized to the eribulin arm compared to the control arm.
Maltese: Fi Studju 309, titjib statistikament sinifikanti fl-OS ġie osservat f'pazjenti magħżula b'mod każwali għall-parti tal-istudju dwar eribulin meta mqabbla mal-parti tal-istudju tal-kontroll.
English: (per protocol population: -0.25 versus -0.12; [95% CI: -0.36; 0.11]).
Maltese: (popolazzjoni skont il-protokoll: -0.25 versus -0.12; [95% CI: -0.36; 0.11]).
English: It may harm them,
Maltese: Insuman Basal tingħata fit-tessut taħt il-ġilda.
English: • alcohol consumption,
Maltese: • konsum tal-alkoħol,
English: MedDRA system organ classes
Maltese: Sistema tal-klassifika tal-organi MedDRA
English: • Device components
Maltese: • Komponenti tal-apparat
English: ATC Code: A10AB01.
Maltese: A10AB01.
English: Diabetic retinopathy; Visual impairment
Maltese: Retinopatija dijabetika; Indeboliment tal-vista
English: 4,000 IU/10 ml
Maltese: 4,000 UI/10 ml
English: Proliferative retinopathy;
Maltese: Retinopatija proliferattiva,
English: • Device programming
Maltese: • Ipprogrammar tal-apparat
English: The pump is not connected to a glucose meter.
Maltese: Il-pompa mhijiex mqabbda ma' glucose meter.
English: • one human insulin preparation to another,
Maltese: • preparazzjoni ta' insulin umana għal oħra,
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst Brüningstraße 50
Maltese: Industriepark Höchst Brüningstraße 50
English: Focal hepatic steatosis (1) (1) Adverse reaction observed with a semi-synthetic human insulin (400 IU/ml)
Maltese: Steatożi epatika fokali (1) (1) Reazzjoni avversa osservata b'Insuplanta insulina semisintetika umana (400
English: After intraperitoneal administration of Insuman Implantable 0.15 IU/kg, the median Tmax was 0.54 hours and Cmax in serum was 210 ± 129 microIU/ml.
Maltese: IU/kg Insuman Implantable minn ġol-peritonew, it-Tmax medjan kien 0.54 sigħat u s-Cmax fis-serum kien 210 ± 129 mikroIU/ml.
English: In patients who have not reached adult size, Insuman Implantable is contraindicated (see section 4.3 and 4.4).
Maltese: F'pazjenti li għandhom ma laħqux id-daqs ta' adulti, Insuman Implantable huwa kontraindikat (ara sezzjoni 4.3 u 4.4).
English: Insuman Infusat").
Maltese: Infusat”).
English: 1 ml contains 40 IU (1.4 mg) insulin human.
Maltese: 1 ml fih 40 IU (1.4 mg) insulina umana.
English: • Additional risk minimisation measures
Maltese: • Miżuri addizzjonali ta' minimizzazzjoni tar-riskju
English: Implant site infection (see section 4.4)
Maltese: Infezzjoni fis-sit tal-impjant (ara sezzjoni 4.4)
English: Reasons for initiation of continuous intra-peritoneal insulin infusion (CIPII) were brittle diabetes in 62.7%, hypoglycaemia in 29.2%, insulin peripheral resistance in 5.0% and hypoglycaemia and brittle diabetes in 3.1%.
Maltese: Ir-raġunijiet għall-bidu ta' infużjoni kontinwa ta' insulina minn ġol-peritonew (CIPII - continuous intra-peritoneal insulin infusion) kienu dijabete fraġli fi 62.7%, ipogliċemija f'29.2%, reżistenza periferali għall-insulina f'5.0% u ipogliċemija u dijabete fraġli fi 3.1%.
English: The mean pharmacokinetic profile is shown in figure 1.
Maltese: Il-medja tal-profil farmakokinetiku hija murija f'figura 1.
English: Problems with the pen?
Maltese: Diffikultajiet bil-pinna?
English: • Implantable Insulin Pump system: Physician Manuals
Maltese: • Sistema ta' Implantable Insulin Pump: Manwali tat-Tabib
English: ► Side effects reported with the implantable pump (including side effects related to implantation of the pump and or pump maintenance)
Maltese: ► Effetti sekondarji rrappurtati bil-pompa għall-impjantar (li jinkludu effetti sekondarji relatati mal-impjantar tal-pompa u l-manteniment tal-pompa)
English: Insuman Basal is an isophane insulin suspension.
Maltese: Insuman Basal hija suspensjoni ta' insulina isophane.
English: The active substance is insulin human.
Maltese: - Is-sustanza attiva hi insulina umana.
English: • Implantable Insulin Pump System: Patient manuals
Maltese: • Sistema ta' Implantable Insulin Pump: Manwali tal-Pazjent
English: Medical imaging technique
Maltese: Teknika ta' immaġini medika
English: Pump refill
Maltese: Fil-pompa
English: • have a tendency to hypoglycaemia,
Maltese: • għandhom tendenza għal ipogliċemija,
English: Intraperitoneal insulin administration was similar to subcutaneous administration as demonstrated by change in HbA1c value from baseline (for continuous intraperitoneal administration: HbA1c value at Day 360 was 7.78 ± 1.04 versus 8.06 ± 0.77 at baseline; for subcutaneous administration: HbA1c value at Day 360 was 8.19 ± 0.87 versus 8.12 ± 0.76 at baseline).
Maltese: L-għoti ta' insulina minn ġol-peritonew kienet tixbah l-għoti taħt ilġilda kif intwera mill-bidla fil-valur ta' HbA1c mil-linja bażi (għal għoti kontinwu mill-peritonew: ilvalur ta' HbA1c f'Jum 360 kien 7.78 ± 1.04 versus 8.06 ± 0.77 fil-linja bażi; għal għoti taħt il-ġilda: ilvalur ta' HbA1c f'Jum 360 kien 8.19 ± 0.87 versus 8.12 ± 0.76 fil-linja bażi).
English: Hypersensitivity to titanium alloy, polysulfone or silicone materials used in the implanted components of the pump.
Maltese: Sensittività għal titanium alloy, polysulfone jew materjali tas-silicone użati fil-komponenti tal-pompa li jiġu impjantati.
English: • Outward bulge in the navel area (Umbilical hernia)
Maltese: • In-naħa taż-żokra tkun mqabbża 'l barra (Umbilical hernia)
English: Insuman Basal").
Maltese: Basal”).
English: 1 ml contains 100 IU (3.5 mg) insulin human.
Maltese: 1 ml fih 100 Unità (3.5 mg) insulina umana.
English: Insuman Rapid").
Maltese: Rapid”).
English: Mean HbA1c value at baseline was 8.1%.
Maltese: Il-valur medju ta' HbA1c fil-linja bażi kien 8.1%.
English: Table 1: Adverse reactions observed in HUBIN_L_05335 study with insulin human 400 IU/ml and clinical experience with insulin human 100 IU/ml and 40 IU/ml.
Maltese: Tabella 1: Reazzjonijiet avversi osservati fl-isudju HUBIN_L_05335 b'400 IU/ml ta' insulina umana u esperjenza klinika b'100
English: SoloStar is a prefilled pen for the injection of insulin.
Maltese: SoloStar, pinna ta' l-insulina.
English: 3 cartridges of 3 ml 4 cartridges of 3 ml 5 cartridges of 3 ml 6 cartridges of 3 ml 9 cartridges of 3 ml 10 cartridges of 3 ml
Maltese: 3 skartoċċita' 3 ml 4 skartoċċi ta' 3 ml 5 skartoċċi ta' 3 ml 6 skartoċċi ta' 3 ml 9 skartoċċi ta' 3 ml 10 skartoċċi ta'3 ml
English: PEN LABEL SOLOSTAR
Maltese: TIKKETTA TAL-PINNA SOLOSTAR
English: Intercurrent illness requires intensified metabolic monitoring.
Maltese: Il-mard interkurrenti jirrikjedi monitoraġġ metaboliku aktar intensiv.
English: The refill procedure should be performed every 40 to 45 days.
Maltese: Il-proċedura ta' mili mill-ġdid għandha ssir kull 40 sa 45 jum.
English: Insuman Infusat is supplied in vials contains 10 ml solution (1000 IU).
Maltese: Insuman Infusat huwa fornut f'kunjetti ta' 10 ml ta' soluzzjoni (1000 IU).
English: Unopened cartridges:
Maltese: nazzjonali xierqa:
English: Pump blockage
Maltese: Pump.
English: ► Side effects reported with the insulin
Maltese: ► Effetti sekondarji rrappurtati bl-insulina
English: Insuman Infusat is supplied in cartridges containing 3.15 ml solution (315 IU).Pack of 5 cartridges of 3.15 ml is available.
Maltese: Insuman Infusat huwa fornut f'skartoċċi li fihom 3.15 ml ta' soluzzjoni (315 IU).
English: The Medtronic MiniMed Implantable Pump is not designed for use at elevations above 2439 meters (8000 feet) or below 7.6 meters (25 feet).
Maltese: 2439 metru (8000 pied) jew taħt 7.6 metru (25 pied).
English: Date of first authorisation: 21 February 1997 Date of latest renewal: 21 February 2007
Maltese: Data tal-aħħar tiġdid: 21 ta' Frar 2007
English: In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes.
Maltese: F'suġġetti b'saħħithom, il-half-life ta' l-insulina fis-serum huwa ta' madwar 4 sa 6 minuti.
English: One 10 ml vial of solution contains 4,000 IU insulin.
Maltese: Kunjett wieħed ta' 10 ml ta' soluzzjoni fih 4,000 IU insulina.
English: Concerning incompatibility with other insulins, see section 6.2.
Maltese: F'dak li għandu x'jaqsam malinkompatibbiltà ma' insulin oħra, ara sezzjoni 6.2.
English: Insuman Implantable is a high-concentrated insulin formulation Insuman Implantable contains 400 international units of insulin in each ml.
Maltese: Insuman Implantable huwa formulazzjoni ta' insulina kkonċentrata ħafna Insuman Implantable fih 400 unità internazzjonali ta' insulina f'kull ml.
English: One ml of Insuman Implantable contains 400 IU (International Units) of the active substance insulin human.
Maltese: Millilitru ta' Insuman Implantable fih 400 UI (Unita Internazzjonali) tas-sustanza attiva insulina umana.
English: Other medicines and Insuman Rapid
Maltese: Mediċini oħra u Insuman Rapid
English: After intraperitoneal administration of 0.15 IU/kg Insuman Implantable, insulin was eliminated from serum with an apparent mean half-life of 2.7 hours.
Maltese: IU/kg Insuman Implantable minn ġol-peritonew, l-insulina tneħħiet mis-serum b'half-life apparenti medja ta' 2.7 sigħat.
English: • suffering from a psychiatric illness,
Maltese: • li qegħdin ibatu minn mard psikjatriku,
English: 1 vial of 5 ml 5 vials of 5 ml 1 vial of 10 ml 5 vials of 10 ml
Maltese: Kunjett 1 ta' 5 ml 5 kunjetti ta' 5 ml Kunjett 1 ta' 10 ml 5 kunjetti ta' 10 ml
English: Insuman Infusat is a neutral insulin solution (regular insulin).
Maltese: Insuman Infusat hija soluzzjoni newtrali ta' insulina (insulina regolari).
English: Tel: +46 (0)8 634 50 00
Maltese: Sanofi AB Tel: +46 (0)8 634 50 00
English: OUTER CARTONS / FOR 100 IU/ml: 5 ml VIAL
Maltese: KARTUN TA' BARRA / GĦAL 100 IU/ml: KUNJETT TA' 5 ml
English: Insuman Rapid is supplied in pre-filled pens, SoloStar, containing 3 ml solution (300 IU).
Maltese: Insuman Rapid huwa fornut f'pinen mimlija għal-lest, SoloStar li fihom 3 ml ta' soluzzjoni (300 IU).
English: Insuman Rapid is a neutral insulin solution (regular insulin).
Maltese: Insuman Rapid hija soluzzjoni newtrali ta' insulina (insulina regolari).
English: You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units.
Maltese: Tista' tissettja d-doża f'qabżiet ta' Unità l-waħda, minn minimu ta' Unità waħda sa massimu ta' 80 Unità.
English: Do not inject insulin.
Maltese: UI t'insulina.
English: Insuman Infusat 100 IU/ml in a vial
Maltese: Insuman Infusat 100 IU/ml f'kunjett
English: Do not use Insuman Infusat in peristaltic pumps with silicone tubing.
Maltese: Tużax Insuman Infusat f'pompi peristaltiċi b'tubi tas-silikown.
English: Units) of the active substance insulin human.
Maltese: Internazzjonali) tas-sustanza attiva insulina umana.
English: Change to Insuman Implantable
Maltese: Mediċini oħra u Insuman Implantable
English: Table 2: Adverse reactions and product technical complaints observed with the delivery system (including adverse reactions related to implantation surgery and or device maintenance).
Maltese: Tabella 2: Reazzjonijiet avversi u lmenti tekniċi dwar il-prodott osservati bis-sistema tal-għoti (inkluż reazzjonijiet avvesi marbuta mal-kirurġija tal-impjantazzjoni u/jew manutenzjoni tal-istrument).
English: It must be remembered that neutral regular insulin precipitates out at a pH of approximately 4.5 to 6.5.
Maltese: Wieħed għandu wkoll jiftakar li l-insulina newtrali u regolari tippreċipita f'pH ta' madwar 4.5 sa 6.5.
English: Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Maltese: remettar, għeja, ngħas, disturbi fl-irqad, nuqqas ta' kwiet, komportament aggressiv, nuqqas ta' attenzjoni, reazzjonijiet imfixklin, depressjoni, konfużjoni mentali, taħwid fid-diskors, (xi drabi it-telf komplet tad-diskors), indeboliment tal-vista, rogħda, paralisi, tnemnim (parasteżija), sensazzjoni mtarrxa u tnemnim fir-reġjun tal-ħalq, sturdament, inabbiltà li trażżan lilek innifsek, inabbiltà li tieħu ħsieb tiegħek innifsek, aċċessjonijiet u t-telf mis-sensi.
English: Insulin administration via the pump can cause a fat infiltration of the liver at single, well-defined locations (called focal hepatic steatosis).
Maltese: L-għoti tal-insulina permezz tal-pompa tista' tikkawża infiltrazzjoni ta' xaħam fil-fwied f'postijiet distinti u definiti sew (imsejħa focal hepatic steatosis).
English: This means that Insuman Implantable is more concentrated than standard insulin.
Maltese: Dan ifisser li Insuman Implantable hija aktar konċentrata minn insulina standard.
English: Following subcutaneous injection, onset of action is within 30 minutes, the phase of maximum action is between 1 and 4 hours after injection and the duration of action is 7 to 9 hours.
Maltese: Wara linjezzjoni fit-tessut ta' taħt il-ġilda, tibda taħdem fi żmien 30 minuta, tilħaq ħidma massima ta' bejn siegħa u 4 sigħat mill-injezzjoni, u ddum taħdem minn 7 sa 9 sigħat.
English: Insuman Implantable is a neutral insulin solution (regular insulin).
Maltese: Insuman Implantable hija soluzzjoni newtrali ta' insulina (insulina regolari).
English: Insuman Implantable administered in continuous intraperitoneal infusion was also similar to semi-synthetic human insulin as demonstrated by the refill accuracy criteria over the 4-refill cycles (per protocol population: mean difference: -3.15 ± 1.34; [95% CI: -5.81; -0.50]).
Maltese: preċiżjoni ta' mili mill-ġdid fuq l-4 ċikli ta' mili mill-ġdid (popolazzjoni skont il-protokoll:differenza medja: -3.15 ± 1.34; [95% CI: -5.
English: Absorption
Maltese: Lipodistrofija
English: • concomitant treatment with certain other medicinal products (see section 4.5).
Maltese: • kura konkomittanti b'ċerti prodotti mediċinali oħra (ara sezzjoni 4.5).
English: Insuman Comb 30 is a biphasic isophane insulin suspension consisting of 30% dissolved insulin and 70% crystalline protamine insulin.
Maltese: Insuman Comb 30 hija suspensjoni ta' insulina isophane f'żewġ fażijiet li tikkonsisti f'30% ta' insulina maħlula u 70% ta' insulina protamine taħt għamla ta' kristalli.