FrancophonIA/ELRC3.0 huggingface dataset:
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4 % and
Maltese: Fir-rigward tal-AUC ta' TMZ, l-esponiment għal MTIC u AIC huwa 2.4 % u 23 %,
English: There is limited information in patients over 3 years of age who have taken Temozolomide Hexal.
Maltese: Hemm informazzjoni limitata f'pazjenti li għandhom 'l fuq minn 3 snin li ħadu Temozolomide Hexal.
English: Opportunistic infections and reactivation of infections Opportunistic infections (such as Pneumocystis jirovecii pneumonia) and reactivation of infections (such as HBV, CMV) have been observed during the treatment with TMZ (see section 4.8).
Maltese: Infezzjonijiet opportunistiċi (bħal pnewmonja Pneumocystis jirovecii) u riattivazzjoni tal infezzjonijiet (bħall-HBV, CMV) ġew osservati matul il-kura b'TMZ (ara sezzjoni 4.8).
English: (usual dose).
Maltese: (doża tas-soltu).
English: Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5); the frequency of grade 3-4 laboratory findings is presented after each table.
Maltese: Il-biċċa tar-reazzjonijiet ematoloġiċi avversi rrapportati b'mod komuni jew komuni ħafna fiż-żewġ indikazzjonijiet (Tabelli 4 u 5); il frekwenza tas-sejbiet tal-laboratorju ta' grad 3-4 tidher wara kull tabella.
English: Package leaflet: information for the user Temozolomide Hexal 5 mg hard capsules Temozolomide Hexal 20 mg hard capsules Temozolomide Hexal 100 mg hard capsules Temozolomide Hexal 140 mg hard capsules Temozolomide Hexal 180 mg hard capsules Temozolomide Hexal 250 mg hard capsules temozolomide
Maltese: Temozolomide Hexal 20 mg kapsuli ibsin Temozolomide Hexal 100 mg kapsuli ibsin Temozolomide Hexal 140 mg kapsuli ibsin Temozolomide Hexal 180 mg kapsuli ibsin Temozolomide Hexal 250 mg kapsuli ibsin temozolomide
English: Temozolomide Hexal contains lactose (a kind of sugar).
Maltese: Temozolomide Hexal fih lactose (tip ta' zokkor).
English: Temozolomide Hexal contains lactose
Maltese: Temozolomide Hexal fih lactose
English: An overdose of 10,000 mg (total dose in a single cycle, over 5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure and death.
Maltese: Doża eċċessiva ta' 10,000 mg (doża totali f'ċiklu wieħed, matul 5 ijiem) ittieħdet minn pazjent u r-reazzjonijiet avversi rrapportati kienu panċitopenija, deni, kollass ta' diversi organi u mewt.
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l
Maltese: - għadd assolut tan-newtrofili (ANC) ≥ 1.5 x 109/l
English: Multipack containing 20 hard capsules (4 packs of 5 hard capsules in a type III amber glass bottle with polypropylene child-resistant closure.
Maltese: Pakkett multiplu li fih 20 kapsula iebsa (4 pakketti ta' 5 kapsuli ibsin fi flixkun tal-ħġieġ kulur ambra tip III b'tapp tal-polypropylene li ma jinfetaħx mit-tfal.
English: Capsule content Anhydrous lactose Colloidal anhydrous silica Sodium starch glycolate type A Tartaric acid
Maltese: Kontenut tal-kapsula Anhydrous lactose Colloidal anhydrous silica Sodium starch glycolate tip A Tartaric acid
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: Each carton contains 5 or 20 hard capsules.
Maltese: Kull kartuna fiha 5 jew 20 kapsula iebsa.
English: The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS=2, n=70), where overall survival and time to progression were similar in both arms.
Maltese: Ir-riżultati mill-prova ma kinux konsistenti fis-sottogrupp ta' pazjenti bi status baxx ta' prestazzjoni (WHO PS=2, n=70), fejn is-sopravivenza globali u ż-żmien sal-progressjoni kienu simili fiż-żewġ gruppi.
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Maltese: - għadd tat-tromboċiti ≥ 100 x 109/l - tossiċità mhux ematoloġika ta' kriterju komuni tat-tossiċità (CTC)ta' ≤ Grad 1 (ħlief għal alopeċja, tqalligħ u rimettar).
English: 9/l
Maltese: NUMRU(I)
English: MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4-carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Maltese: MTIC huwa idrolizzat b'mod spontanju għal 5-amino imidazole-4-carboxamide (AIC), intermedju magħruf fil-bijosintesi tal-purine u aċidi nuklejiċi u għal methylhydrazine, li huwa maħsub li huwa l-ispeċi attiv li jagħmel l-alkalizzazzjoni.
English: Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1-2 weeks.
Maltese: Majelosuppressjoni kienet prevedibbli (normalment fl-ewwel ftit ċikli, bin-nadir ikun bejn Jum 21 u Jum 28), u l-irkupru kien wieħed mgħaġġel, normalment fi żmien 1-2 ġimgħat.
English: Other medicines and Temozolomide Hexal
Maltese: Mediċini oħra u Temozolomide Hexal
English: This led to hospitalisation and/or discontinuation of TMZ in 8 % and 4 %, respectively.
Maltese: Dan wassal għal rikoveru l-isptar u/jew waqfien ta' TMZ fi 8 % u f'4 %, rispettivament.
English: Paediatric patients had a higher AUC than adult patients; however, the maximum tolerated dose (MTD) was 1,000 mg/m2 per cycle both in children and in adults.
Maltese: Pazjenti pedjatriċi kellhom AUC ogħla minn dak ta' pazjenti adulti; madankollu, id-doza massima ttollerata (MTD) kienet ta' 1,000 mg/m kull ċiklu kemm fit-tfal kif ukoll fl-adulti.
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia,
Maltese: koordinament anormali, mixja mhux normali, iperesteżija,
English: • chills
Maltese: • morliti
English: In patients treated with TMZ, whether used in combination with RT or as monotherapy following RT for newly-diagnosed glioblastoma multiforme, or as monotherapy in patients with recurrent or progressive glioma, the reported very common adverse reactions were similar: nausea, vomiting, constipation, anorexia, headache and fatigue.
Maltese: F'pazjenti ikkurati b'TMZ, kemm ikkombinat ma' RT, kif ukoll bħala monoterapija wara RT għal glioblastoma multiforme li kienet għadha kif ġiet iddijanjostikata, jew bħala monoterapija f'pazjenti bi glijoma rikorrenti jew progressiva, ir-reazzjonijiet avversi komuni ħafna rrapportati kienu simili: tqalligħ, rimettar, stitikezza, anoressija, uġigħ ta' ras u għejja.
English: When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8 % of the patients.
Maltese: Meta l anormalitajiet tal-laboratorju u l-avvenimenti avversikienu kkombinati tul il-fażijiet ta' kura konkomittanti u dik bħala monoterapija, kienu osservati anormalitajiet ta' Grad 3 jew ta' Grad 4 finnewtrofili, inkluż avvenimenti newtropeniċi fi 8% tal-pazjenti.
English: P.T.Hadjigeorgiou Co Ltd 31 Yildiz Street, 3042 Limassol Τηλ: 00357 - 25372425 info.pth@cytanet.com.cy
Maltese: P.T.Hadjigeorgiou Co Ltd 31 Yildiz Street, 3042 Limassol
English: Following oral administration, approximately 5 % to 10 % of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4-carboxamide (AIC) or unidentified polar metabolites.
Maltese: Wara għoti orali, madwar 5 % sa 10 % tad-doża tiġi rkuprata mhux mibdula fl-awrina fuq medda ta' 24 siegħa, u l-bqija tiġi eliminata bħala aċidu temozolomide, 5-aminoimidazole-4
English: EU/1/10/616/017 EU/1/10/616/018 EU/1/10/616/033 EU/1/10/616/034 EU/1/10/616/041
Maltese: EU/1/10/616/017 EU/1/10/616/018 EU/1/10/616/033 EU/1/10/616/034
English: Temozolomide Hexal is indicated for the treatment of: adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment, children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Maltese: tfal b'età minn tliet snin 'il fuq, adoloxxenti u pazjenti adulti bi glijoma malinna, bħal glioblastoma multiforme jew astroċitoma anaplastika, li jerġgħu jirkadu jew li jkollhom avvanz tal-marda wara terapija ta' livell normali.
English: Temozolomide Hexal 5 mg capsules temozolomide
Maltese: Temozolomide Hexal 5 mg kapsuli ibsin temozolomide
English: Blood and lymphatic system disorders
Maltese: Sistema tallassifika tal-organi
English: • followed by treatment with only Temozolomide Hexal (monotherapy phase).
Maltese: • segwita minn kura b'Temozolomide Hexal biss (fażi ta' monoterapija).
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.
Maltese: Grad 4 fit-tromboċiti, inkluż effetti tromboċitopeniċi dehru f'14 % tal-pazjenti li ngħataw TMZ.
English: Temozolomide Hexal 250 mg capsules temozolomide
Maltese: Temozolomide Hexal 250 mg kapsuli ibsin temozolomide
English: Temozolomide Hexal 180 mg hard capsules Each capsule contains 180 mg temozolomide.
Maltese: Temozolomide Hexal 180 mg kapsuli ibsin Kull kapsula fiha 180 mg ta' temozolomide.
English: A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 109/l and platelet count > 100 x 109/l.
Maltese: Għadd komplet tad-demm għandu jinkiseb f'22 jum (21 jum wara l-ewwel doża) jew sa 48 siegħa minn dak il-jum, u kull ġimgħa sakemm l-ANC ikun > 1.5 x 109/l u l-għadd tal-plejtlets ikun > 100 x 109/l.
English: Temozolomide Hexal 140 mg capsules temozolomide
Maltese: Temozolomide Hexal 140 mg kapsuli ibsin temozolomide
English: Temozolomide Hexal 20 mg capsules temozolomide
Maltese: Temozolomide Hexal 20 mg kapsuli ibsin temozolomide
English: Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Maltese: II, l-għoti flimkien ta' dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, antagonisti tar-riċettur ta' H2, jew phenobarbital ma biddilx l-eliminazzjoni ta' TMZ.
English: Temozolomide Hexal 180 mg capsules temozolomide
Maltese: Temozolomide Hexal 180 mg kapsuli ibsin temozolomide
English: Then you will have 23 days without Temozolomide Hexal.
Maltese: Imbagħad ser jkollok 23 jum mingħajr Temozolomide Hexal.
English: Administration of TMZ with food resulted in a 33 % decrease in Cmax and a 9 % decrease in area under the curve (AUC).
Maltese: L-għoti ta' TMZ mal-ikel irriżulta fi tnaqqis ta' 33 % fisCmax u fi tnaqqis ta' 9 % fl-erja taħt il-kurva
English: You will again take Temozolomide Hexal once daily for 5 days followed by 23 days without Temozolomide Hexal.
Maltese: Ser terġa' tieħu Temozolomide Hexal darba kuljum għal 5 ijiem segwit bi 23 jum mingħajr Temozolomide Hexal.
English: Temozolomide Hexal 250 mg hard capsules Each capsule contains 250 mg temozolomide.
Maltese: Temozolomide Hexal 250 mg kapsuli ibsin Kull kapsula fiha 250 mg ta' temozolomide.
English: Temozolomide Hexal 100 mg capsules temozolomide
Maltese: Temozolomide Hexal 100 mg kapsuli ibsin temozolomide
English: Temozolomide Hexal 20 mg hard capsules Each capsule contains 20 mg temozolomide.
Maltese: Temozolomide Hexal 20 mg kapsuli ibsin Kull kapsula fiha 20 mg ta' temozolomide.
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Temozolomide in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Maltese: għandhom riskju akbar li jkollhom newtropenija u tromboċitopenijanewtropenijatromboċitopenija
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 %
Maltese: TMZ tikkettat b'14C, il-medja tal-ammont ta' 14C fl-ippurgar aktar minn 7 ijiem wara d-doża kienet 0.8% li tindika assorbiment komplet.
English: TMZ dosing interruption or discontinuation duringconcomitant radiotherapy and TMZ
Maltese: Dożi waqt Ċikli 2-6 jekk ma jkunx hemm tossiċità
English: • in adults with newly-diagnosed glioblastoma multiforme.
Maltese: • f' adulti li jkunu għadhom kif ġew dijanjostikati bi glioblastoma multiforme.
English: Oral TMZ has been studied in paediatric patients (age 3-18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen administered daily for 5 days every 28 days.
Maltese: TMZ orali kien studjat f'pazjenti pedjatriċi (età 3-18-il sena) bi glijoma rikorrenti taz-zokk ċentrali tal-moħħjew b'astroċitoma rikorrenti ta' grad għoli, f'kors mogħti kuljum għal 5 ijiem kull 28 jum.
English: Temozolomide Hexal 140 mg hard capsules Each capsule contains 140 mg temozolomide.
Maltese: Temozolomide Hexal 140 mg kapsuli ibsin Kull kapsula fiha 140 mg ta' temozolomide.
English: After oral administration to adult patients, TMZ is absorbed rapidly with peak concentrations reached as early as 20 minutes post-administration (mean time between 0.5 and 1.5 hours).
Maltese: Wara l-għoti orali lil pazjenti adulti, TMZ jiġi assorbit malajr, bl-ogħla konċentrazzjonijiet jintlaħqu sa 20 minuta wara li jkun ingħata (ħin medju ta' bejn 0.5 u 1.5 sigħat).
English: Temozolomide Hexal 100 mg hard capsules pink
Maltese: Temozolomide Hexal 100 mg kapsuli ibsin roża
English: Temozolomide Hexal 100 mg hard capsules Each capsule contains 100 mg temozolomide.
Maltese: Temozolomide Hexal 100 mg kapsuli ibsin Kull kapsula fiha 100 mg ta' temozolomide.
English: Temozolomide Hexal 140 mg hard capsules blue
Maltese: Temozolomide Hexal 140 mg kapsuli ibsin blu
English: EU/1/10/616/038 20 (4 packs of 5) hard capsules
Maltese: EU/1/10/616/038 20 (4 pakketti ta' 5) kapsula iebsa
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance peripheral neuropathy
Maltese: Emipleġja, atassja, koordinament anormali, mixja mhux normali,
English: EU/1/10/616/009 EU/1/10/616/010 EU/1/10/616/029 EU/1/10/616/030 EU/1/10/616/039
Maltese: EU/1/10/616/029 EU/1/10/616/030 EU/1/10/616/039
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia,
Maltese: Il-kura b'TMZ mogħti b'mod konkomittanti tista' titkompla meta jintlaħqu dawn il-kondizzjonijiet kollha li ġejjin: għadd assolut tan-newtrofili ≥ 1.5 x 109/l; għadd tat-tromboċiti ≥ 100 x 109/l; tossiċità mhux ematoloġika ta' CTC ta' ≤ Grad 1 (ħlief għal alopeċja, tqalligħ, rimettar).
English: CTC non-haematological toxicity (except for alopecia, nausea, vomiting) CTC Grade 2
Maltese: Tossiċità mhux ematoloġika ta' CTC (ħlief għal alopeċja, tqalligħ,rimettar)
English: EU/1/10/616/041 20 (4 packs of 5) hard capsules
Maltese: EU/1/10/616/041 20 (4 pakketti ta' 5) kapsula iebsa
English: Temozolomide Hexal is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Maltese: Temozolomide Hexal jingħata flimkien ma' radjuterapija fokali (fażi konkomittanti) segwit b'mhux aktar minn 6 cikli ta' monoterapija ta' temozolomide (TMZ) (fażi ta' monoterapija).
English: EU/1/10/616/042 20 (4 packs of 5) hard capsules
Maltese: EU/1/10/616/042 20 (4 pakketti ta' 5) kapsula iebsa
English: Temozolomide Hexal 180 mg hard capsules maroon
Maltese: Temozolomide Hexal 180 mg kapsuli ibsin
English: EU/1/10/616/037 20 (4 packs of 5) hard capsules
Maltese: EU/1/10/616/037 20 (4 pakketti ta' 5) kapsula iebsa
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temozolomide Hexal for 42 days in combination with radiotherapy.
Maltese: Jekk int pazjent li għadek kif ġejt dijanjostikat (glioblastoma multiforme) tista' tingħata Temozolomide Hexal għal 42 jum flimkien ma' radjuterapija.
English: EU/1/10/616/039 20 (4 packs of 5) hard capsules
Maltese: EU/1/10/616/039 20 (4 pakketti ta' 5) kapsula iebsa
English: Temozolomide Hexal 20 mg hard capsules
Maltese: Temozolomide Hexal 20 mg kapsuli ibsin
English: EU/1/10/616/013 EU/1/10/616/014 EU/1/10/616/031 EU/1/10/616/032 EU/1/10/616/040
Maltese: EU/1/10/616/031 EU/1/10/616/032 EU/1/10/616/040
English: EU/1/10/616/001 EU/1/10/616/002 EU/1/10/616/025 EU/1/10/616/026 EU/1/10/616/037
Maltese: EU/1/10/616/001 EU/1/10/616/002 EU/1/10/616/025
English: The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60 % to 100 % of rats and dogs tested, degeneration of the retina occurred.
Maltese: Il-miri primarji tat-tossiċità nkludew il-mudullun, is-sistema limforettikulari, it-testikoli u l-apparat gastro-intestinali u, f'dożi aktar qawwija, li kienu letali għal 60 % sa 100 % tal-firien u l-klieb ittestjati, seħħet deġenerazzjoni tar-retina.
English: • tingling sensation
Maltese: • impotenza sesswali
English: Temozolomide Hexal 5 mg hard capsules
Maltese: Temozolomide Hexal 5 mg kapsuli ibsin
English: Temozolomide Hexal 250 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Maltese: Temozolomide Hexal 250 mg kapsuli ibsin Kontenut tal-kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
English: Temozolomide Hexal 250 mg hard capsules white
Maltese: Temozolomide Hexal 250 mg kapsuli ibsin
English: Temozolomide Hexal 5 mg hard capsules Each capsule contains 5 mg temozolomide.
Maltese: Temozolomide Hexal 5 mg kapsuli ibsin Kull kapsula fiha 5 mg ta' temozolomide.
English: Temozolomide Hexal 140 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Maltese: Temozolomide Hexal 140 mg kapsuli ibsin Kontenut tal-kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
English: • muscle weakness
Maltese: • stonku minfuħ
English: Temozolomide Hexal 100 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Maltese: Temozolomide Hexal 100 mg kapsuli ibsin Kontenut tal-kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
English: Special populations Paediatric population In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma.
Maltese: Pazjenti adulti u pedjatriċi minn 3 snin 'l fuq bi glijoma malinna rikorrenti jew progressiva
English: EU/1/10/616/040 20 (4 packs of 5) hard capsules
Maltese: EU/1/10/616/040 20 (4 pakketti ta' 5) kapsula iebsa
English: Temozolomide Hexal 100 mg hard capsules
Maltese: Temozolomide Hexal 100 mg kapsuli ibsin
English: Temozolomide Hexal 140 mg hard capsules
Maltese: Temozolomide Hexal 140 mg kapsuli ibsin
English: hypoesthesia, neurological disorder (NOS), peripheral neuropathy sensory disturbance
Maltese: indeboliment tal-konċentrazzjoni, disfażja, disturbi newroloġiċi
English: Thus, prophylaxis against PCP is required for all patients receiving concomitant TMZ and RT for the 42-day regimen (with a maximum of 49 days) regardless of lymphocyte count.
Maltese: Għalhekk hija meħtieġa profilassi kontra PCP għall-pazjenti kollha li jkunu qegħdin jirċievu TMZ flimkien ma' RT għall-kors ta' 42 jum (b'massimu ta' 49 jum) ikun xi jkun l-għadd tal-limfoċiti.
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide Hexal only: A treatment cycle with Temozolomide Hexal lasts 28 days.
Maltese: Pazjenti b'tumuri li jkunu rritornaw jew aggravaw (glijoma malinna, bħal glioblastoma multiforme jew astroċitoma anaplastika) li jkunu qegħdin jieħdu Temozolomide Hexal biss:
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS),
Maltese: sturdament, indeboliment talmemorja, indeboliment tal konċentrazzjoni, disfażja, disturbi newroloġiċi (NOS),
English: Then, you will start the monotherapy phase.
Maltese: kura ta' monoterapija.
English: Thrombocyte count
Maltese: • tbati biex tikkonċentra
English: Temozolomide Hexal contains a medicine called temozolomide.
Maltese: Temozolomide Hexal fih mediċina msejħa temozolomide.
English: • a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty),
Maltese: • reazzjoni allerġika serja (sensittività eċċessiva) (ħorriqija, tħarħir jew diffikultà oħra fit-teħid tan-nifs), • fsada mhux ikkontrollata,
English: It can only be
Maltese: Jista'
English: Vantobra is a ‘hybrid medicine'.
Maltese: Vantobra huwa ‘mediċina ibrida'.
English: The full EPAR and risk management plan summary for Vantobra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vantobra on 18 March 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vantobra fit-18 ta' Marzu 2015.
English: This is a summary of the European public assessment report (EPAR) for Vantobra.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vantobra.
English: The active substance in Vantobra, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'.
Maltese: Is-sustanza attiva f'Vantobra, tobramycin, tagħmel parti mill-grupp ta' antibijotiċi magħrufin bħala “aminoglikosidi”.
English: The recommended dose is one ampoule twice a day, ideally 12 hours apart.
Maltese: Id-doża rakkomandata hija ampulla waħda darbtejn kuljum, idealment bi 12-il siegħa bejniethom.
English: However, the following side effects are seen between 1 and 10 patients in 1,000: dyspnoea (difficulty breathing), dysphonia (hoarseness), pharyngitis (sore throat) and cough.
Maltese: Madankollu, l-effetti sekondarji li ġejjin huma osservati f'bejn pazjent 1 u 10 minn kull 1,000: qtugħ ta' nifs (diffikultà fin-nifs), disfonja (ħanqa), farinġite (uġigħ fil-griżmejn) u sogħla.
English: It contains the active substance tobramycin, which is the same active substance as that of the reference medicine, Tobi.
Maltese: Fih is-sustanza attiva tobramycin, li hija l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Tobi.
English: In addition, the applicant conducted a ‘bioequivalence' study in 58 patients with cystic fibrosis aged 6 years and above to determine whether Vantobra produces similar levels of the active substance in the body as the reference medicine, Tobi.
Maltese: Barra minn hekk, l-applikant wettaq studju ta' “bijoekwivalenza” fi 58 pazjent b'fibrożi ċistika li għandhom 6 snin jew aktar biex jiddetermina jekk Ventobra jipproduċix livelli simili tas-sustanza attiva fil-ġisem bħall-mediċina ta' referenza, Tobi.
English: Tobramycin has been used for several years to treat P. aeruginosa infection in patients with cystic fibrosis and the applicant submitted data from the literature to support the use of Vantobra.
Maltese: Tobramycin intuża għal diversi snin biex jikkura l-infezzjoni P. aeruginosa f'pazjenti b'fibrożi ċistika u lapplikant issottometta dejta mid-dokumentazzjoni biex jappoġġja l-użu ta' Vantobra.