FrancophonIA/ELRC3.0 huggingface dataset:
English: In very rare cases, haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.
Maltese: F'każijiet rari ħafna dijarea emorraġika, ematemesi, ulċerazzjoni gastrointestinali u livelli għolja ta' enzimi tal-fwied ġew irrappurtati.
English: Marketing authorisation holder Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate Monaghan
Maltese: Detenturtal-awtorizzazzjoni għat-tqegħid fis-suq Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate Monaghan
English: Avoid introduction of contamination during use.
Maltese: Evita l-introduzzjoni ta' kontaminazzjoni waqt l-użu.
English: Loxicom 5 mg/ml solution for injection for dogs and cats meloxicam2.
Maltese: Loxicom 5 mg/ml soluzzjoni għall-injezzjoni għall-klieb u l-qtates meloxicam2.
English: Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids (oxicams), ATC vet code: QM01AC06
Maltese: Prodotti anti-infjammatorji u anti-rewmatiċi, mhux sterojdi (oxicams)
English: Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.
Maltese: Ittrattament għandu jitkompla darba kuljum bl-għoti orali (f'intervalli ta '24 siegħa) b'doża ta' manteniment ta '0.1 mg ta' meloxicam / kg.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Maltese: Evita l-użu fi kwalunkwe annimal deidratat, ipovolemiku jew ipotensiv għax hemm riskju potenzjali ta' tossiċità tal-kliewi.
English: Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e., 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Maltese: Injezzjoni waħda taħt il-ġilda jew ġol-vina, b'dożaġġ ta' 0.5 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e. 2.5 ml / 100 kg ta' piż tal-ġisem) flimkien ma' terapija antibijotika, jew ma' terapija orali ta' idratazzjoni mill-ġdid, skont kif ikun xieraq.
English: Ulbrokas 23, Rīga, LV-1021, Latvija Tel. +371 6716 0091
Maltese: Magnum Veterinārija SIA Ulbrokas 23, Rīga, LV-1021, Latvija
English: Lietuva UAB "Magnum Veterinarija"
Maltese: Għandu jingħata biss b'riċetta veterinarja.
English: Number of chewable tablets 1 mg
Maltese: Numru ta' pilloli li jintmagħadu 1.0 mg
English: Single administration of 0.2 mg meloxicam/kg bodyweight (i.e. 0.04 ml/kg) when administration of meloxicam is to be continued as an oral follow-up therapy
Maltese: Injezzjoni waħda taħt il-ġilda b'dożaġġ ta' 0.2 mg ta' meloxicam/kg ta' piż tal-ġisem (i.e. 0.04 ml/kg) it-trattament għandu jitkompla bl-għoti orali.
English: Ref.: EMA/758850/2009 EMEA/H/C/391
Maltese: Dok. ta' ref.:EMEA/758850/2009 EMEA/H/C/391
English: Doc.
Maltese: Lumigan
English: Lumigan bimatoprost EPAR summary for the public
Maltese: Bimatoprost Sommarju tal-EPAR għall-pubbliku
English: The active substance in Lumigan, bimatoprost, is a prostaglandin analogue (a man-made copy of a natural substance, prostaglandin).
Maltese: Is-sustanza attiva f'Lumigan, bimatoprost, hija analogu ta' prostaglandin (kopja ta' sustanza naturali, prostaglandin, magħmula mill-bniedem).
English: Eye pressure is measured in ‘millimetres of mercury' (mmHg).
Maltese: Il-pressjoni flgħajn hija mkejla f'‘millimetri ta' merkurju' (mmHg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lumigan to Allergan Pharmaceuticals Ireland on 8 March 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Lumigan lil Allergan Pharmaceuticals Ireland fit-8 ta' Marzu 2002.
English: An additional 12-month study compared Lumigan 0.1 mg/ml with Lumigan 0.3 mg/ml, and with an intermediate strength of 0.125 mg/ml, in 561 patients.
Maltese: Studju ta' 12 -il xahar addizzjonali qabbel Lumigan 0.1 mg/ml ma' Lumigan 0.3 mg/ml u ma' doża intermedjarja ta' 0.125 mg/ml f'561 pazjent.
English: It is available in two strengths, 0.1 and 0.3 mg per millilitre.
Maltese: Huwa disponibbli f'żewġ dożi ta' 0.1 u 0.3 mg għal kull millilitru.
English: Lumigan 0.3 mg/ml was also more effective than latanoprost, with patients using Lumigan achieving a reduction in eye pressure of 6.0 to 8.2 mmHg after six months of treatment compared with 4.9 to 7.2 mmHg with latanoprost.
Maltese: Lumigan 0.3 mg/ml kien ukoll aktar effettiv minn latanoprost, fejn pazjenti li użaw Lumigan kisbu tnaqqis fil-pressjoni ta' l-għajn li jvarja bejn 6.0 sa 8.2 mmHg wara sitt xhur ta' kura meta mqabbla ma' tnaqqis ta' 4.9 sa 7.2 mmHg b'latanoprost.
English: Lumigan contains benzalkonium chloride, which is known to discolour soft contact lenses.
Maltese: Lumigan fih benzalkonium chloride, li huwa magħruf li jtebba' lentijiet tal-kuntatt rotob.
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni abbażi għar-rakkomandazzjonijiet tas-CHMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: Some of these patients carried on receiving the medicines for up to two or three years (379 and 183 patients, respectively).
Maltese: Xi wħud mill-pazjenti baqgħu jirċievu l-mediċini għal sentejn jew tliet snin (379 u 183 pazjent rispettivament).
English: Lumigan was as effective as latanoprost when added to beta-blocker treatment, with reductions in eye pressure of 8.0 and 7.4 mmHg, respectively, after three months.
Maltese: Lumigan kien effikaċi daqs latanoprost meta żdied ma' kura b'imblokkatur tar-riċetturi beta, bi tnaqqis fil-pressjoni ta' l-għajn ta' 8.0 u 7.4 mmHg, rispettivament, wara tliet xhur.
English: Lumigan 0.1 mg/ml brought about slightly smaller decreases in IOP than Lumigan 0.3 mg/ml.
Maltese: Lumigan 0.1 mg/ml ġab bidliet żgħar ta' tnaqqis f'IOP minn Lumigan 0.3 mg/ml.
English: Lumigan 0.3 mg/ml used on its own has been compared with timolol (a beta-blocker used to treat glaucoma) in two 12-month studies involving a total of 1,198 patients.
Maltese: Lumigan 0.3 mg/ml użat waħdu tqabbel ma' timolol (imblokkatur tar-riċetturi beta użat għall-kura ta' glawkoma) f'żewġ studji ta' 12il xahar li kienu jinvolvu total ta' 1,198 pazjent.
English: Lumigan has been studied in adults with glaucoma or ocular hypertension.
Maltese: Lumigan ġie studjat fl-adulti bi glawkoma jew ipertensjoni okulari.
English: What is the risk associated with Lumigan?
Maltese: X'inhu ir-riskju assoċjat ma' Lumigan?
English: This effect was maintained after two or three years of treatment, with an average reduction in eye pressure of between 7.1 and 8.6 mmHg with Lumigan used once a day, compared with 4.6 to 6.4 mmHg with timolol.
Maltese: Dan l-effett inżamm wara sentejn jew tliet snin ta' kura, bi tnaqqis medju fil-pressjoni ta' l-għajnejn li jvarja bejn 7.1 u 8.6 mmHg b'Lumigan użat darba kuljum, meta imqabbel ma' tnaqqis minn 4.6 sa 6.4 mmHg b'timolol.
English: The full EPAR for Lumigan is available here.
Maltese: Għalfejn ġie approvat Lumigan?
English: After three months, eye pressure was lowered by 7.4 mmHg in the group adding Lumigan, compared with 3.6 mmHg in the group adding placebo.
Maltese: Wara tliet xhur, il-pressjoni flgħajn tnaqqset b'7.4 mmHg fil-grupp li żied Lumigan, meta mqabbel ma' 3.6 mmHg fil-grupp li żied plaċebo.
English: Adding Lumigan 0.3 mg/ml to existing treatment with a beta-blocker was more effective than continuing to use the beta-blocker on its own.
Maltese: Iż-żieda ta' Lumigan 0.3 mg/ml ma' kura eżistenti b'imblokkatur tar-riċetturi beta kienet aktar effettiva milli l-użu mkompli ta' imblokkatur tar-riċetturi beta waħdu.
English: How does Lumigan work?
Maltese: X'benefiċċji wera Lumigan waqt l-istudji?
English: Because Lumigan 0.1 mg/ml contains higher levels of benzalkonium chloride than Lumigan 0.3 mg/ml, Lumigan 0.1 mg/ml must not be used in people who have had a reaction to a product containing benzalkonium chloride in the past, and had to stop using the product containing it as a result.
Maltese: Minħabba li Lumigan 0.1 mg/ml fih livelli ogħla ta' benzalkonium chloride minn Lumigan 0.3 mg/ml, Lumigan 0.1 mg/ml ma għandux jintuża f'nies li kellhom reazzjoni għal prodott li fih il-benzalkonium chloride fil-passat, u kellhom iwaqqfu l-użu tal-prodott li kien fih dan bħala riżultat.
English: In a patient with ocular hypertension or glaucoma, the value is generally higher than 21 mmHg.
Maltese: F'pazjent b'ipertensjoni okulari jew bi glawkoma, il-valur ikun ġeneralment aktar minn 21 mmHg.
English: It has also been compared with latanoprost (another prostaglandin analogue used in glaucoma) in a six-month study involving 269 patients.
Maltese: Huwa ġie mqabbel ukoll ma' latanoprost (analogu ieħor ta' prostaglandin użat fi glawkoma) fi studju ta' sitt xhur li kien jinvolvi 269 pazjent.
English: Lumigan's effect when added to beta-blocker treatment has also been compared with that of latanoprost in another study in 437 patients.
Maltese: L-effett ta' Lumigan meta ġie miżjud ma' kura b'beta-blocker tqabbel ukoll ma' latanoprost fi studju ieħor ta' 437 pazjent.
English: Other information about Lumigan:
Maltese: Tagħrif ieħor dwar Lumigan:
English: The effect of adding Lumigan 0.3 mg/ml to existing treatment with a beta-blocker eye drop has been compared with that of adding placebo (a dummy eye drop) in one study involving 285 patients.
Maltese: L-effett taż-żieda ta' Lumigan 0.3 mg/ml ma' kura diġà eżistenti bi qtar għall-għajnejn beta-blocker tqabbel ma' waħda li żżid plaċebo (qtar għall-għajnejn finta) fi studju wieħed li kien jinvolvi 285 pazjent.
English: The medicine can only be obtained with a prescription.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq hija valida għal żmien mhux limitat.
English: Lumigan is a clear eye drop solution that contains the active substance bimatoprost.
Maltese: Lumigan huwa soluzzjoni ta' qtar trasparenti għall-għajnejn li fih is-sustanza attiva bimatoprost.
English: Lumigan 0.3 mg/ml on its own was more effective than timolol at reducing eye pressure.
Maltese: Lumigan ta' 0.3 mg/ml waħdu kien aktar effettiv minn timolol biex inaqqas il-pressjoni fl-għajn.
English: List of the names, pharmaceutical form, strengths of the medicinal product, route of administration, applicants in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwa tal-prodotti mediċinali, mod ta' amministrazzjoni u applikanti fl- Istati Membri
English: Strength Pharmaceutical form Route of administration
Maltese: Għamla Farmaċewtika Mod ta' kif jingħata
English: CTC Grade 3
Maltese: CTC Grad 2
English: Temozolomide Accord may cause permanent infertility.
Maltese: Temozolomide Accord jista' jikkawża infertilità permanenti.
English: Polyester/aluminium/polyethylene (PET/alu/PE) sachet.
Maltese: Qartas tal-polyester/aluminju/polyethylene (PET/alu/PE).
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 ijiem) ġew evalwati klinikament f'pazjenti.
English: Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/m2.
Maltese: Il-livelli tad-doża jinkludu 100 mg/m2, 150 mg/m2, u 200 mg/m2.
English: Lutomierska 50,95-200 Pabianice, Poland
Maltese: Lutomierska 50,95-200
English: TMZ monotherapy n=224
Maltese: TMZ waħdu n=224
English: Hallucination, amnesia
Maltese: Alluċinazzjoni, amneżija
English: This latency period is very short even for an alkylating agent.
Maltese: Il-perijodu ta' latency huwa qasir ħafna, anke għal alkylating agent.
English: A treatment cycle comprises 28 days.
Maltese: Ċiklu ta' trattament idum 28 jum.
English: 20 hard capsules
Maltese: 20 kapsula iebsa
English: Tolerance to TMZ is similar to adults.
Maltese: It-tolleranza għal-TMZ kienet simili għall-adulti.
English: Middlesex, HA1 4HF, United Kingdom
Maltese: Middlesex, HA1 4HF,
English: Elderly patients (> 70 years of age)
Maltese: Pazjenti anzjani (>70 sena)
English: (chi-square p = 0.019).
Maltese: procarbazine (44 %) (chi-square p = 0.019).
English: Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01A X03
Maltese: Sustanzi antineoplastiċi - alkylating agents oħra, Kodiċi ATC L01A X03
English: Opportunistic infections, including PCP
Maltese: Infezzjonijiet opportunistiċi, li jinkludu PCP
English: System organ class TMZ + concomitant RT n=288*
Maltese: TMZ + RT flimkien n=288*
English: Pancytopenia, anaemia (grade 3-4), leukopenia
Maltese: Panċitopenija, anemija (grad 3-4), lewkopenija
English: TMZ dose (mg/m2 /day)
Maltese: Doża (mg/m2/jum)
English: Gelatine
Maltese: Gelatin
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4% and 23%, respectively.
Maltese: L-esponiment għal MTIC u AIC relattiv għall-AUC ta' TMZ huwa ta' ~ 2.4 % u 23 %, rispettivament.
English: There is limited information in patients over 3 years of age who have taken Temozolomide Accord.
Maltese: Hemm informazzjoni limitata f'pazjenti li għandhom 'l fuq minn 3 snin li ħadu Temozolomide Accord.
English: Each carton contains 5 or 20 sachets.
Maltese: Kull kartuna fiha 5 jew 20 qartas.
English: - The other ingredients are: capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Maltese: - Is-sustanzi l-oħrajn: kontenut tal-kapsula: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
English: 5 hard capsules 20 hard capsules
Maltese: 5 kapsuli ibsin 20 kapsula iebsa
English: Frequency groupings are defined according to the following convention: Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Maltese: Mhux komuni (≥ 1/1,000 to < 1/100); Rari (≥1/10,000 sa <1/1,000);
English: TMZ demonstrates low protein binding (10% to 20%), and thus it is not expected to interact with highly protein-bound substances.
Maltese: TMZ jeħel b'mod ħafif mal-proteini (10% sa 20%), u għalhekk mhux mistenni li jinteraġixxi ma' sustanzi li jeħlu ħafna mal-proteini.
English: Temozolomide Accord 5 mg hard capsules Temozolomide Accord 20 mg hard capsules Temozolomide Accord 100 mg hard capsules Temozolomide Accord 140 mg hard capsules Temozolomide Accord 180 mg hard capsules Temozolomide Accord 250 mg hard capsules temozolomide
Maltese: Temozolomide Accord 5 mg kapsuli ibsin Temozolomide Accord 20 mg kapsuli ibsin Temozolomide Accord 100 mg kapsuli ibsin Temozolomide Accord 140 mg kapsuli ibsin Temozolomide Accord 180 mg kapsuli ibsin Temozolomide Accord 250 mg kapsuli ibsin temozolomide
English: In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
Maltese: In vivo t-t1/2 ta' MTIC kien simili għal dak ta' TMZ, 1.8 siegħa.
English: Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
Maltese: Newtropenija jew limfopenija (grad 3- 4), tromboċitopenija (grad 3-4)
English: Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskolu-skeletrali u tat-tessut konnettiv Komuni:
English: Herpes simplex, herpes zoster, influenza-like symptoms
Maltese: Herpes simplex, herpes zoster, sintomi bħal talinfluwenza
English: Discontinue TMZ
Maltese: Waqqaf TMZ
English: Gastrointestinal disorders Very Common:
Maltese: Disturbi gastrointestinali Komuni ħafna:
English: The hazard ratio (HR) for overall survival was 1.59 (95% CI for HR=1.33 -1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
Maltese: Il-proporzjon tal-periklu (HR) għas-sopravivenza ġenerali kienet ta' 1.59 (95 % CI għal HR=1.33 - 1.91) b'log rank p < 0.0001 favur il-fergħa ta' TMZ.
English: Capsule shell Gelatine
Maltese: Qoxra tal-kapsula Gelatin
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 każwali kkontrollata b'mod attiv, il-PFS wara 6 xhur kien akbar b'mod sinifikanti 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: Endocrine disorders* Uncommon:
Maltese: Disturbi fis-sistema endokrinarja* Mhux komuni:
English: TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
Maltese: TMZ ikun idrolizzat b'mod spontanju fil-pH fiżjoloġiku għall-ispeċi attivi, 3-methyl-(triazen-1-yl)imidazole-4-carboxamide (MTIC).
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, Meningoencephalitis herpetic†, sepsis†
Maltese: infezzjoni b'cytomegalovirus, attivazzjoni mill-ġdid ta' infezzjonijiet bħal cytomegalovirus, u virus talepatite B†, Meningoenċefalite ħerpetika†, sepsis†
English: Titanium dioxide (E171) Indigo carmine (E132).
Maltese: Titanium dioxide (E171) Indigo carmin (E132)
English: Temozolomide is an anti-cancer medicine.
Maltese: Temozolomide huwa prodott mediċinali kontra l-kanċer.
English: One was a non-comparative trial in 138 patients (29% received prior chemotherapy), and the other was a randomised active-controlled trial of TMZ vs. procarbazine in a total of 225 patients (67% received prior treatment with nitrosourea based chemotherapy).
Maltese: Waħda kienet prova mhux komparattiva f'138 pazjent (29 % kienu ngħataw ilkemoterapija qabel), u l-oħra kienet prova każwali kkontrollata b'mod attiv ta' TMZ vs procarbazine f'total ta' 225 pazjent (67 % kienu ngħataw kura qabel bil-kemoterapija bbażata fuq nitrosourea).
English: Temozolomide Accord contains lactose
Maltese: Temozolomide Accord fih lactose
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: Recurrent anaplastic astrocytoma
Maltese: Astroċitoma anaplastika rikurrenti
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 għas-sustanza attiva ta' monomethyl triazenoimidazole carboxamide (MTIC).
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 % ta' Cmax u fi tnaqqis ta' 9 % fl-erja taħt ilkurva (AUC).
English: Abdominal distension, faecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Maltese: Nefħa taż-żaqq, inkontinenza talippurgar, disturbi gastrointestinali (NOS), gastroenterite, emorrojdi
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 12 January 2015
Maltese: Data tal-aħħar tiġdid: 12 ta' Jannar 2015
English: A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286).
Maltese: Total ta' 573 pazjent ġew magħżula kif ġie ġie biex jingħataw jew TMZ + RT (n=287) jew RT biss (n=286).
English: PHARMACEUTICAL FORM AND CONTENTS 5 hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 5 kapsuli ibsin
English: Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Maltese: Emoraġija vaġinali, menorraġja, amenorrea, vaġinite, uġigħ fis-sider
English: Medical attention may be required.
Maltese: Għandu mnejn ikun meħtieġ li tingħata attenzjoni medika.
English: TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57%) in the RT alone arm, and 62 patients of the 277 (22%) in the TMZ + RT arm.
Maltese: TMZ kien mogħti bħala terapija tas-salvataġġ fil-fażi ta' follow-up f'161 pazjent mill-282 (57 %) fil-fergħa b'RT waħdu, u f'62 pazjent mill-277 (22 %) fil-fergħa ta' TMZ + RT.
English: Each hard capsule contains 14.6 mg of anhydrous lactose.
Maltese: Kull kapsula iebsa fiha 14.6 mg ta' lattosju anidru.
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 fissuq:
English: In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43%) and vomiting (36%).
Maltese: Fi provi kliniċi, l-aktar effetti mhux mixtieqa relatati mal-kura li seħħew ta' spiss kienu disturbi gastrointestinali, speċifikament dardir (43 %) u rimettar (36 %).
English: Infections and infestations* Uncommon:
Maltese: Infezzjonijiet u infestazzjonijiet* Mhux komuni:
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Maltese: Emipleġija, atassja, koordinament anormali, andatura mhux normali, iperesteżija, disturbi sensorjali
English: Hard capsule.
Maltese: Kapsula iebsa
English: Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population)
Maltese: Kaplan-Meier għas-sopravivenza ġenerali (popolazzjoni maħsuba għal kura)
English: Titanium dioxide (E171)
Maltese: Ilma Titanium dioxide (E171)
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-4carboxamide (AIC) or unidentified polar metabolites.
Maltese: Wara għotja orali, madwar 5 % sa 10 % tad-doża tiġi rkuprata mhux mibdula mill-awrina fuq 24 siegħa, u l-bqija eliminat bħala aċidu ta' TMZ, 5-aminoimidazole-4-carboxamide (AIC) jew metaboli polari li ma ġewx identifikati.
English: Anorexia
Maltese: Anoressja
English: Each hard capsule contains 73 mg of anhydrous lactose.
Maltese: Kull kapsula iebsa fiha 73 mg ta' lattosju anidru.
English: Agitation, apathy, behaviour disorder, depression, hallucination
Maltese: Aġitazzjoni, apatija, disturbi flimġieba, dipressjoni, alluċinazzjoni
English: printing ink: shellac, propylene glycol, black iron oxide (E172) and potassium hydroxide.
Maltese: xellak, propylene glycol, black iron oxide (E172), potassium hydroxide.
English: Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral TMZ.
Maltese: Dejta dwar l-effikaċja klinika f'pazjenti bi glijoblastoma multiforme (Stat tal-prestazzjoni Karnofsky [KPS] ≥ 70), progressiva jew rikurrenti wara operazzjoni u RT, kienet ibbażata fuq żewġ provi kliniċi b'TMZ orali.
English: TMZ is an embryotoxic, teratogenic and genotoxic alkylating agent.
Maltese: TMZ huwa sustanza alkylating embrijotossiku, teratoġeniku, u ġinotossiku.
English: Muscle weakness, arthralgia Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Maltese: Dgħjufija fil-muskoli, artralġja, uġigħ muskolu-skeletriku, mijalġja
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 talH2, jew phenobarbital ma biddlux it-tneħħija ta' TMZ.
English: • palpitations (abnormal heart beats)
Maltese: • palpitazzjonijiet (il-qalb tħabbat b'mod anormali)
English: Temozolomide comes in different strength capsules (shown on the outer label in mg).
Maltese: Temozolomide jiġi f'kapsuli ta' qawwiet differenti (li jidhru fuq it-tikketta ta' barra f'mg).
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-verifikatur ċentrali, kienet ta' 35 % (13 CR u 43 PR) għallpopolazzjoni maħsuba għal kura (ITT) n=162.