FrancophonIA/ELRC3.0 huggingface dataset:
English: Triangular, peach-coloured, film-coated tablets debossed with “Pfizer” on one side and “OPR 05” on the other side.
Maltese: Pilloli miksija b'rita li huma trijangulari, ta' kulur il-ħawħa, b'“Pfizer” immarkata fuq naħa waħda u “OPR 05” fuq in-naħa l-oħra.
English: Benign breast neoplasm, breast fibroma, chronic lymphocytic leukaemia, endometrial neoplasm, female reproductive neoplasm, haemangioma, hepatic neoplasm malignant, leiomyoma, melanocytic naevus, multiple myeloma, neoplasm, parathyroid tumour
Maltese: Emanġjoma, fibroma fis-sider, lewkimja limfoċitika kronika, lejomajoma, naevus melanoċitiku, neoplażma, neoplażma beninn tas-sider, neoplażma fis-sistema riproduttiva tan-nisa, neoplażma malinn tal-fwied, neoplażma tal-endometriju, tumur beninn filparatirojde, tumur multiplu malinn tal-mudullun tal-għadam Disturbi tad-demm u tas-sistema limfatika
English: A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1).
Maltese: Ġie ppruvat tnaqqis sinifikanti fl-inċidenza ta' ksur vertebrali u dak mhux vertebrali, iżda mhux fl-inċidenza ta' ksur tal-ġenbejn (ara sezzjoni 5.1).
English: Adenomyosis, adnexa uteri cyst, adnexa uteri mass, breast discharge, breast engorgement, breast fibrosis, enlarged clitoris, fallopian tube cyst, nipple disorder, nipple pain, perineal laceration, pruritus genital, uterine cervical squamous metaplasia, uterine haemorrhage, uterine mass, vaginal erosion, vaginal inflammation, vaginal pain, vaginal wall congestion, varicose veins vulval, vulvar disorder Congenital, familial and genetic disorders Rare:
Maltese: Akkumulazzjoni ta' fluwidu fl-utru, colpocele, displasja ċervikali, disturbi fis-sider tan-nisa, disturbi fl-għonq tal-utru, ebusija fis-sider, emorraġija ġenitali, emorraġija ta' wara lmenopawsa, emorraġija vaġinali, erożjoni ċervikali tal-utru, ħakk fil-vulva u l-vaġina, iperplasija tal-endometriju** (skont rapporti tal-investigazzjonijiet), l-utru joħroġ barra minn postu, polipi ċervikali, prolass vaġinali, rectocele, tnixxija anormali tad-demm mill
English: MARKETING AUTHORISATION NUMBER EU/1/08/500/001
Maltese: NUMRU TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/500/001
English: 90 film-coated tablets
Maltese: 90 pillola miksija b'rita
English: Relative to placebo, FABLYN significantly decreased total cholesterol, LDL cholesterol, LDL-associated apolipoprotein B-100, and high sensitivity C-reactive protein (median changes -10.4%, -15.8%, -11.8%, -12.5%, respectively); no significant changes versus placebo were seen for HDL cholesterol or VLDL cholesterol.
Maltese: 4%, -15.8%, -11.8%, -12.5%, rispettivament); ma dehru l-ebda bidliet sinifikanti filkolesterol tat-tip HDL jew kolesterol tat-tip VLDL meta pparagunati mal-plaċebo.
English: FABLYN does not eliminate the risk of breast cancer (see section 5.1).
Maltese: FABLYN ma jeliminax ir-riskju tal-kanċer tas-sider (ara sezzjoni 5.1).
English: Uncommon: Palpitations, tachycardia
Maltese: Komuni: Fwawar tal-menopawsa
English: Placebo-treated women had a 1.9% incidence in cystic change over 3 years, whereas the FABLYNtreated women had a 20.4% incidence.
Maltese: In-nisa li kienu qegħdin jiġu kkurati bil-plaċebo kellhom inċidenza ta' bidla fiċ-ċesti ta' 1.9% matul 3 snin, filwaqt li n-nisa li kienu qegħdin jiġu kkurati bilplaċebo kellhom inċidenza ta' 20.
English: Film-coated tablet.
Maltese: FARMAĊEWTIKA U KONTENUT
English: When determining the choice of FABLYN or other therapies, including estrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Maltese: Meta jkun qiegħed jiġi deċiż li mara li tkun għaddiet mill-menopawsa għandha tingħata FABLYN jew terapiji oħra, inklużi l-estroġeni, wieħed għandu jqis is-sintomi tal-menopawsa, l-effett fuq it-tessuti tal-utru u tas-sider, u riskji u benefiċċji kardjovaskulari (ara sezzjoni 5.1).
English: Aortic aneurysm, arterial occlusive disease, capillary disorder, embolism, haematoma, haemorrhage, intermittent claudication, lymphostasis, thrombosis, vascular stenosis, venous thrombosis, venous thrombosis limb Respiratory, thoracic and mediastinal disorders Uncommon: Cough, pulmonary embolism, rhinitis allergic Rare:
Maltese: Amnesija, dimenzja tat-tip tal-marda Alzheimer, disgewsja, emigranja, emigranja b'sintomi li wieħed iħosshom qabel attakk tal-epilessija, epilessija, idroċefalu, ipogewsja, kompressjoni tan-nervituri, marda tan-nerv tac-caqlieq, paresi, presinkope, sturdament assocjat mal-pożizzjoni tal-ġisem, telf tal-memorja, uġiegħ ta' ras saskulari, xjatika Distrubi fl-għajnejn Mhux komuni: Rari:
English: 5′ nucleotidase increased, blood albumin decreased, blood creatinine abnormal, blood triglycerides increased, blood urine present, bone density decreased, chest X-ray abnormal, electrocardiogram T wave abnormal, gamma-glutamyltransferase increased, hepatitis B surface antigen positive, high density lipoprotein decreased, low density lipoprotein increased, pedal pulse decreased, platelet count decreased, ultrasound breast
Maltese: Krejatinina fid-demm anormali, l-antiġen tal-wiċċ tal-epatite B pożittiv, mewġa T talelettrokardjogramm anormali, preżenza tad-demm fl-awrina, riżultat tal-eżami ultrasoniku tal-ovarji anormali, riżultat tal-eżami ultrasoniku tas-sider anormali, tnaqqis fid-densità talgħadam, tnaqqis fil-lipoproteina ta' densità għolja, tnaqqis fil-pedal pulse, tnaqqis fl-għadd tal-pjastrini fid-demm tnaqqis fl-albumina fid-demm, X-ray anormali tas-sider, żieda fil- 5′ nucleotidase, żieda fil-gamma-glutamyltransferase, żieda fil-lipoproteina ta' densità baxxa żieda fit-trigliċeridi fid-demm
English: Hepatically impaired patients:
Maltese: Infezzjonijiet u infestazzjonijiet Mhux komun:
English: In all women with a uterus at baseline, histologically benign endometrial polyps were reported in 34 of 2,302 (1.5%) FABLYN-treated women versus 18 of 2,309 (0.8%) placebo-treated women.
Maltese: Fin-nisa kollha li kellhom l-utru fil-linja bażi, ġew irrappurtati polipi fl-endometriju li huma istoloġikament beninni f'34 minn 2302 (1.5%) mara li kienu qegħdin jiġu kkurati b'FABLYN meta pparagunat ma' 18 minn 2309 (0.8%) mara li kienu qegħdin jiġu kkurati bil-plaċebo.
English: Similar results for vaginal pH and MI were observed in the PEARL study.
Maltese: Dan it-tnaqqis kien osservat matul l-ewwel sena u nżamm matul il-5 snin.
English: Children and adolescents below 18 years of age:
Maltese: Tfal u adoloxxenti ta' taħt it-18-il sena:
English: Contains lactose See the package leaflet for further information.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għal skop kummerċjali.
English: More FABLYN-treated patients (7.0%) had a diagnostic procedure compared to placebo-treated patients (2.7%).
Maltese: Kien ammont ikbar ta' pazjenti kkurati b'FABLYN (7.0%) li kellhom proċedura dijanjostika meta pparagunati mal-pazjenti kkurati bil-plaċebo (2.7%).
English: Women in this study had a median age of 63 years (range 44 to 79) and a median time since menopause of 13 years.
Maltese: In-nisa li kienu qegħdin jipparteċipaw f'dan l-istudju kellhom età medja ta' 63 sena (medda minn 44 sa 79 sena) u medja ta' 13-il sena minn meta kellhom il-menopawa.
English: • The approaches recommended for mitigation of risk of venous thromboembolism based on the
Maltese: • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL-FORNIMENT U L-UŻU
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon: Fibroma, uterine leiomyoma Rare:
Maltese: Dawn l-effetti sekondarji jistgħu jidhru b'ċerti frekwenzi, li huma definiti kif ġej:
English: What FABLYN looks like and contents of the pack FABLYN tablets are triangular, peach coloured, film-coated tablets marked with “Pfizer” on one side and “OPR 05” on the other.
Maltese: Il-pilloli FABLYN huma trijangulari, kulur il-ħawħa, u miksija b'rita, b'”Pfizer” immarkata fuq naħa waħda u “OPR 05” fuq in-naħa l-oħra.
English: Calculus bladder, hypercalciuria, hypertonic bladder, nephrosclerosis, urethral haemorrhage, urinary bladder polyp, urinary tract disorder Reproductive system and breast disorders
Maltese: Candidiasis fil-vaġina, infezzjoni fil-vaġina, infezzjoni fis-sistema urinarja, infjammazzjoni
English: The efficacy of FABLYN in the treatment of VVA was investigated in two 12-week Phase 3 studies in postmenopausal women with moderate or severe signs and symptoms of VVA, regardless of osteoporosis status (involving 889 patients).
Maltese: L-effikaċja ta' FABLYN fil-kura tal-VVA kienet investigata f'żewġ studji ta' Fażi 3 li damu 12-il ġimgħa u saru fuq nisa li diġà għaddew mill-menopawsa li kellhom sinjali u sintomi ta' VVA moderati jew severi, u dan irrispettivament mill-istat tal-osteoporożi tagħhom (li involvew 889 pazjenta).
English: Placebo-treated women had a 0.7 mm mean decrease from baseline in endometrial thickness over 3 years, whereas the FABLYN-treated women had a 1.4 mm mean increase.
Maltese: In-nisa li kienu kkurati bil-plaċebo kellhom tnaqqis medju fil-ħxuna tal-endometriju ta' 0.7 mm mil-linja bażi matul 3 snin, filwaqt li n-nisa li kienu kkurati b'FABLYN kellhom żieda medja ta' 1.4 mm.
English: Common: Constipation
Maltese: Komuni: Stitikezza
English: • Hot flush
Maltese: • Bidla fl-aptit
English: 28 capsules
Maltese: 28 kapsula
English: EU/1/13/848/001 Erivedge
Maltese: EU/1/13/848/001 Erivedge 150 mg Kapsuli, iebsa Użu orali flixkun (HDPE)
English: Pack size
Maltese: Daqs talpakkett
English: Oral use bottle (HDPE)
Maltese: Isem (ivvintat)
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru tal-MA (EU)
English: 150mg
Maltese: Mnejn għandu jingħata
English: SL-1526 Ljubljana Slovenia
Maltese: SL-1526 Ljubljana Is-Slovenja
English: Opportunistic infections, including PCP
Maltese: Infezzjonijiet opportunistiċi, inkluż PCP
English: V J Salomone Pharma Limited Upper Cross Road, Marsa MRS 1542
Maltese: V J Salomone Pharma Limited Upper Cross Road, Marsa
English: A-6250 Kundl
Maltese: A-6250
English: TMZ + concomitant RT n=288*
Maltese: TMZ + RT konkomittanti n=288*
English: Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben Germany
Maltese: Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben
English: Eesti filiaal Pärnu mnt 105
Maltese: Sandoz d.d. Eesti filiaal Pärnu mnt 105
English: Laboratory parameters
Maltese: Parametri tal-laboratorju
English: Hypersensitivity to dacarbazine (DTIC).
Maltese: Sensittività eċċessiva għal dacarbazine (DTIC).
English: Impotence
Maltese: Impotenza
English: Hard capsule (capsule).
Maltese: Kapsula iebsa (kapsula).
English: • The active substance is temozolomide.
Maltese: • Is-sustanza attiva hija temozolomide.
English: TMZ monotherapy n=224
Maltese: Monoterapija b'TMZ n=224
English: Toxicity
Maltese: Tossiċità
English: Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/m2.
Maltese: Il-livelli taddożi jinkludu 100 mg/m2, 150 mg/m2, u 200 mg/m2.
English: CTC Grade 3
Maltese: CTC Grad 3
English: System organ class
Maltese: Sistema talklassifika tal-organi
English: Polyester/aluminium/polyethylene (PET/alu/PE) sachet.
Maltese: Qartas tal-poliester/aluminju/polietilene (PET/alu/PE).
English: Side effects from clinical studies:
Maltese: Effetti sekondarji minn provi kliniċi:
English: • seizures (convulsions),
Maltese: • aċċessjonijiet (konvulżjonijiet),
English: • confusion
Maltese: • konfużjoni
English: Doses of 500, 750, 1,000, and 1,250 mg/m2 (total dose per cycle over 5 days) have been evaluated clinically in patients.
Maltese: Dożi ta' 500, 750, 1,000, u 1,250 mg/m2 (doża totali kull ċiklu matul 5 tijiem) ġew evalwati klinikament f'pazjenti.
English: 23 %, respectively.
Maltese: kien ta' 46 %.
English: Temozolomide Sandoz may cause permanent infertility.
Maltese: Temozolomide Sandoz jista' jikkawża infertilità permanenti.
English: K.Valdemāra 33 - 30
Maltese: K.Valdemāra 33 - 30 LV-1010
English: Endocrine disorders*
Maltese: Disturbi fis-sistema endokrinarja*
English: Sandoz Polska Sp. z o.o.
Maltese: Sandoz Polska Sp. z o.o. ul.
English: Rash, alopecia
Maltese: Raxx, alopeċja
English: In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
Maltese: In vivo it-t1/2 ta' MTIC kien simili għal dak ta' TMZ, 1.8 siegħa.
English: Sandoz GmbH Biochemiestraße 10 A-6250 Kundl Austria
Maltese: Sandoz GmbH Biochemiestraße 10 A-6250
English: • bronchitis
Maltese: • bronkite
English: Erythema multiforme, erythroderma, urticaria, exanthema
Maltese: Erythema multiforme, eritroderma, urtikarja, eksantema
English: Infection, candidiasis oral
Maltese: Infezzjoni, kandidijażi orali
English: Hallucination, amnesia
Maltese: Alluċinazzjoni, amnesija
English: myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia
Maltese: sindrome majelodisplastiku (MDS - myelodysplastic syndrome), mard sekondarju malinn, inkluż lewkimja majelojde
English: Tolerance to TMZ is similar to adults.
Maltese: It-tolleranza għal TMZ hija simili għal dik tal-adulti.
English: TMZ Dose (mg/m2/day)
Maltese: (mg/m2/jum)
English: • pneumonia
Maltese: • pulmonite
English: Vascular disorders Common:
Maltese: Disturbi vaskulari Komuni:
English: Anorexia
Maltese: Anoressija
English: Frimley Business Park Frimley, Camberley Surrey GU16 7SR - UK Tel: +44 1276 69 8020 uk.regaffairs@sandoz.com
Maltese: Frimley Business Park Frimley, Camberley Surrey GU16 7SR - UK Tel: +44 1276 69 8020
English: • urticaria (hives)
Maltese: • urtikarja (ħorriqija)
English: PC: {number} SN: {number} NN: {number}
Maltese: {numru} NN: {numru}
English: Response rate, based on the central reviewer assessment, was 35 % (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Maltese: Ir-rata ta' rispons, ibbażata fuq il-valutazzjoni tal-reviżur ċentrali, kienet ta' 35 % (13 CR u 43 PR) għall-popolazzjoni b'intenzjoni li tiġi kkurata (ITT) n=162.
English: Allergic reactions, including anaphylaxis, angioedema
Maltese: Reazzjonijiet allerġiċi, inkluż anafilassi, anġjoedema
English: toxic epidermal necrolysis, Stevens-Johnson syndrome
Maltese: nekrolisi tossika tal-ġilda, sindrome ta' StevensJohnson
English: Paediatric population Interaction studies have only been performed in adults.
Maltese: Popolazzjoni pedjatrika Studji ta' interazzjoni twettqu biss f'adulti.
English: 5 capsules 20 capsules
Maltese: 5 kapsuli ibsin 20 kapsula iebsa
English: Infections and infestations Common:
Maltese: Infezzjonijiet u infestazzjonijiet Komuni:
English: Herpes simplex, herpes zoster, influenza-like symptoms
Maltese: Herpes simplex, ħerpes zoster, sintomi bħal tal-influwenza
English: Pancytopenia, anaemia (grade 3-4), leukopenia
Maltese: Panċitopenija, anemija (Grad 3-4), lewkopenja
English: ≥ 0.5 and < 1.5 x 109/l
Maltese: ≥ 0.5 u < 1.5 x 109/l
English: Contains lactose.
Maltese: Fih lactose.
English: Investigations Common:
Maltese: Investigazzjonijiet Komuni:
English: Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Maltese: Nefħa addominali, inkontinenza tal-ippurgar, disturbi gastrointestinali (NOS), gastroenterite, emorrojdi
English: ≥ 10 and < 100 x 109/l
Maltese: ≥ 10 u < 100 x 109/l
English: Remarks
Maltese: Rimarki
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l
Maltese: - għadd assolut tan-newtrofili (ANC) ≥ 1.5 x 109/l
English: • abnormal liver function tests.
Maltese: • testijiet tal-funzjoni tal-fwied mhux normali.
English: Palpitation
Maltese: Palpitazzjonijiet
English: H-1114 Budapest Tel: +36 1 430 2890 registration.hungary@sandoz.com
Maltese: Budapest Tel: +36 1 430 2890 registration.hungary@sandoz.com
English: • anxiety/depression
Maltese: • ansjetà/dipressjoni
English: Sandoz Farmacéutica, S.A Centro Empresarial Parque Norte C/ Serrano Galvache Nº 56, Edificio Roble E-28033 Madrid
Maltese: Sandoz Farmacéutica, S.A Centro Empresarial Parque Norte C/ Serrano Galvache Nº 56, Edificio Roble E-28033 Madrid Tel: +34 91 602 30 62 registros.spain@sandoz.com
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 19 November 2014
Maltese: Data tal-aħħar tiġdid: 19 ta' Novembru 2014
English: In the randomised active-controlled trial, the PFS at 6 months was significantly greater for TMZ than for procarbazine (21 % vs 8 %, respectively - chi-square p = 0.008) with median PFS of 2.89 and 1.88 months respectively (log rank p = 0.0063).
Maltese: Fil-prova randomizzata ikkontrollata b'mod attiv, il-PFS wara 6 xhur kien ferm akbar għal TMZ milli għal procarbazine (21 % vs 8 %, rispettivament - chi-square p = 0.008) bil-PFS medjan ta' 2.89 u 1.88 xhur rispettivament (log rank p = 0.0063).
English: TMZ demonstrates low protein binding (10 % to 20 %), and thus it is not expected to interact with highly protein-bound substances.
Maltese: TMZ juri li jeħel b'mod ħafif mal-proteini (10% sa 20%), u għalhekk mhux mistenni li jinteraġixxi ma' sustanzi li jeħlu ħafna mal-proteini.
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4 % and 23 %, respectively.
Maltese: Fir-rigward tal-AUC ta' TMZ, l-esponiment għal MTIC u AIC huwa 2.4 % u 23 %,
English: TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen-1-yl)imidazole-4-carboxamide (MTIC).
Maltese: TMZ huwa idrolizzat b'mod spontanju fil-pH fiżjoloġika għall-ispeċi attiva, 3-methyl-(triazen-1yl)imidazole-4-carboxamide (MTIC).
English: † Including cases with fatal outcome * Frequencies estimated based on relevant clinical trials.
Maltese: Inkluż każijiet b'riżultat fatali * Frekwenzi stmati abbażi ta' provi kliniċi relevanti.
English: Capsule shell Gelatin
Maltese: Qoxra tal-kapsula Gelatin
English: 1 capsule
Maltese: 1 kapsuli ibsin
English: 5 x 1 hard capsule in sachet 20 x 1 hard capsule in sachet
Maltese: 5 x 1 kapsula iebsa f'qartas 20 x 1 kapsula iebsa f'qartas
English: DK-2300 Kööpenhamina S/Köpenhamn S
Maltese: DK-2300 Kööpenhamina
English: Severe myelosuppression (see section 4.4).
Maltese: Majelosoppressjoni severa (ara sezzjoni 4.4).
English: The median PFS was 5.4 months.
Maltese: Il-PFS medjan kien ta' 5.4 xhur.
English: These reactions were usually Grade 1 or 2 (0 - 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Maltese: Dawn ir-reazzjonijet kienu normalment ta' Grad 1 jew 2 (0 - 5 episodji ta' rimettar f'24 siegħa) u jew waqfu waħidhom jew kienu kkontrollati b'terapija kontra t-tqalligħ standard.
English: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100 Rare
Maltese: Mhux komuni (≥ 1/1,000 sa < 1/100); Rari (≥1/10,000 sa <1/1,000);
English: Temozolomide Sandoz contains lactose (a kind of sugar).
Maltese: Temozolomide Sandoz fih lactose (tip ta' zokkor).
English: P-2740−255 Porto Salvo Tel: +351 21 196 40 42 regaff.portugal@sandoz.com
Maltese: Porto Salvo Tel: +351 21 196 40 42 regaff.portugal@sandoz.com
English: Recurrent anaplastic astrocytoma
Maltese: Astroċitoma anaplastika rikorrenti
English: Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Maltese: Emorraġija vaġinali, menorraġija, amenorreja, vaġinite, uġigħ fis sider
English: Embolism pulmonary, oedema, oedema peripheral
Maltese: Emboliżmu fil-pulmun, edema, edema periferali
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, Sepsis†
Maltese: infezzjoni bħal cytomegalovirus, virus tal-epatite B†, meningoenċefalite erpetika†, sepsis†
English: Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
Maltese: Temozolomide huwa triazene, li fil-pH fiżjoloġiku jinbidel malajr fis-sustanza attiva monomethyl triazenoimidazole carboxamide (MTIC).
English: There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 109/l), 9 % vs 3 %, in women vs men in the first cycle of therapy.
Maltese: Kien hemm rati ogħla ta' newtropenija ta' Grad 4 (ANC < 0.5 x 109/l), 12 % vs 5 %, u tromboċitopenija (< 20 x 109/l), 9 % vs 3 % fin-nisa vs l-irġiel fl ewwel ċiklu tat-terapija.
English: interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure†
Maltese: pulmonite tal-interstizju/pulmonite, fibrożi talpulmuni, insuffiċjenza respiratorja†
English: • impaired coordination
Maltese: • indeboliment fil-koordinazzjoni
English: Table 6.
Maltese: Tabella 6.
English: There is limited information in patients over 3 years of age who have taken Temozolomide Sandoz.
Maltese: Hemm informazzjoni limitata f'pazjenti li għandhom 'l fuq minn 3 snin li ħadu Temozolomide Sandoz.
English: Nervous system disorders Very common:
Maltese: Disturbi fis-sistema nervuża Komuni ħafna:
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Maltese: Tromboċitopenija u newtropenija ta' Grad 3 jew 4 seħħew fi 19 % u fi 17 % , rispettivament, tal pazjenti kkurati għal glijoma malinna.
English: Titanium dioxide (E 171) Water
Maltese: Titanium dioxide (E 171) Ilma
English: Not known drug reaction with eosinophilia and systemic symptoms (DRESS)
Maltese: reazzjoni għall-mediċina b'eosinofilja u sintomi sistemiċi (DRESS - drug reaction with eosinophilia and systemic symptoms)
English: Discontinue TMZ
Maltese: Naqqas TMZ
English: The first dose will be 150 mg/m2.
Maltese: L-ewwel doża se tkun ta' 150 mg/m2.
English: The following additional serious adverse reactions have been identified during post-marketing exposure:
Maltese: Ir-reazzjonijiet avversi serji addizzjonali li ġejjin ġew identifikati waqt esponiment wara t-tqegħid fis suq:
English: Package leaflet: information for the user Temozolomide Sandoz 5 mg hard capsules Temozolomide Sandoz 20 mg hard capsules Temozolomide Sandoz 100 mg hard capsules Temozolomide Sandoz 140 mg hard capsules Temozolomide Sandoz 180 mg hard capsules Temozolomide Sandoz 250 mg hard capsules temozolomide
Maltese: Temozolomide Sandoz 20 mg kapsuli ibsin Temozolomide Sandoz 100 mg kapsuli ibsin Temozolomide Sandoz 140 mg kapsuli ibsin Temozolomide Sandoz 180 mg kapsuli ibsin Temozolomide Sandoz 250 mg kapsuli ibsin temozolomide
English: TMZ is an embryotoxic, teratogenic and genotoxic alkylating agent.
Maltese: TMZ huwa sustanza alkylating embrijotossika, teratoġenika, u ġenotossika.
English: Titanium dioxide (E 171) Indigo carmine (E 132) Water
Maltese: Titanium dioxide (E 171) Indigo carmine (E 132) Ilma
English: • rash
Maltese: • raxx
English: • as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
Maltese: • peress li inti trid tinżamm taħt osservazzjoni stretta għall-iżvilupp ta' forma serja ta' infezzjoni fis-sider imsejħa pulmonite Pneumocystis jirovecii (PCP).
English: LV-1010 Rīga Tel: +371 67892006 balt.regaffairs@sandoz.com
Maltese: Tel: +371 67892006 balt.regaffairs@sandoz.com
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000):
English: Lek Pharmaceuticals d.d.
Maltese: Lek Pharmaceuticals d.d. Verovškova 57
English: diabetes insipidus
Maltese: dijabete insipidus
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Latvia brunch
Maltese: Sandoz d.d. Latvia brunch
English: Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population)
Maltese: Kaplan-Meier għas-sopravivenza ġenerali (popolazzjoni b'intenzjoni li tiġi kkurata)
English: Each one lasts 28 days.
Maltese: Ċiklu ta' kura huwa magħmul minn 28 jum.