FrancophonIA/ELRC3.0 huggingface dataset:
English: o all patients should know that UV blocking is not effective in blocking visible light o Patients should be aware of potential risk factors (skin phototype and hepatic o Patients should be instructed to seek medical advice if signs/symptoms suggestive of photosensitivity occur during or after therapy with porfimer.
Maltese: o Pazjenti għandhom jingħataw struzzjonijiet sabiex ifittxu attenzjoni medika jekk ikun hemm sinjali/sintomi ta' fotosensittività waqt u wara t-terapija b'porfimer.
English: o they have trachea or broncho-oesophageal fistulas.
Maltese: o għandhom fistli fit-trakea jew bronki-esofaġeali o ikollhom tmermir suspettat tal-vażi tad-demm ewlenin.
English: Patient alert card − The need to show this card to any doctor treating them photosensitivity are possible o Commercially available sun blocks are not effective in preventing sensitivity due to light o Photosensitivity can only be prevented by avoiding exposure to the sun for 90 days after receiving the PhotoBarr injection
Maltese: − Li PhotoBarr o Jibqa' fil-ġisem għal 60-90 jum wara li tingħata l-injezzjoni o Jiġi attivat bid-dawl viżibbli o Hemm riskju ogħla ta' fotosensittività (sensittività għad dawl) o Il-ġilda esposta ser issir ħamra u tikkawża skonfort f'ħafna każijiet imma każijiet severi ta' fotosensittività huma possibbli o Sun blocks kummerċjalment disponibbli m'humiex effettivi biex o Fotosensittività tista' tiġi evitata billi ma jkunx hemm espożizzjoni għax-xemx għal 90 jum wara li tirċievi injezzjoni ta' PhotoBarr
English: The Member States shall agree the details educational materials with the MAH according to national regulations and healthcare systems and ensure that it is implemented nationally so that all health care professionals who intend to prescribe and/or dispense PhotoBarr are provided with the following:
Maltese: L-Istati Membri għandhom jiftehmu d-dettalji dwar il-materjal edukattiv mad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq skont ir-regolamenti nazzjonali u s-sistemi ta' kura tas-saħħa li għandu jiżgura li dan jiġi implimentat b'mod nazzjonali sabiex il-professjonisti talkura tas-saħħa kollha li jixtiequ jippreskrivu u/jew jagħtu PhotoBarr ikunu fornuti b'dan li ġej:
English: − It is important to have an appropriate light dose and a proper setting for the laser.
Maltese: − Huwa importanti li tingħata d-doża xierqa ta' dawl u kontroll xieraq għal-laser.
English: − Patients should be warned of the possibility of long term side effects, especially photosensitivity, and the need to seek medical assistance if they arise.
Maltese: − Pazjenti għandhom jingħataw twissija dwar il-possibilità ta' effetti kollaterali fuq tul ta' żmien, speċjalment fotosensittività, u l-bżonn ta' assistenza medika jekk ikun hemm bżonn.
English: Prescriber guide and Prescriber slide kit
Maltese: KUNDIZZJONIJIET JEW RESTRIZZJONIJIET LI JRIDU JIĠU IMPLIMENTATI
English: − It is important to follow exactly the correct steps for reconstitution and administration of porfimer.
Maltese: − Huwa importanti li ssegwi eżattament l-istadji korretti għar-rikostituzzjoni u l-għoti ta' porfimer.
English: • Prescriber slide kit
Maltese: • Kitt ta' slides għal min jikteb ir-riċetti
English: • Prescriber guide
Maltese: MILL-ISTATI
English: Baycox Iron is a veterinary medicine.
Maltese: Baycox Iron huwa mediċina veterinarja.
English: Baycox Iron received a marketing authorisation valid throughout the EU on 20 May 2019.
Maltese: Baycox Iron ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-20 ta' Mejju 2019.
English: Further information on Baycox Iron can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/baycox-iron.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/baycox-iron.
English: Other information about Baycox Iron
Maltese: Informazzjoni oħra dwar Baycox Iron
English: In a field study performed in 3 EU countries and involving 968 piglets on farms with a history of coccidiosis, a single intramuscular injection of Baycox Iron given at 3 days of age was effective in preventing iron deficiency anaemia, and reducing oocyst excretion and diarrhoea associated with coccidiosis caused by the coccidia parasite Cystoisospora suis, in comparison with giving iron only (as gleptoferron) at 3 days of age.
Maltese: Fi studju fuq il-post imwettaq fi tliet pajjiżi tal-UE u li involva 968 qażquż fuq irziezet bi storja ta' koċċidjożi, injezzjoni intramuskolari waħda ta' Baycox Iron li ngħatat fit-tielet jum wara t-twelid kienet effettiva fil-prevenzjoni ta' anemija kkawżata minn defiċjenza ta' ħadid, u fit-tnaqqis ta' eskrezzjoni ooċista u ta' dijarea assoċjati mal-koċċidjożi kkawżata mill-parassita koċċidja Cystoisospora suis meta mqabbla mal-għoti tal-ħadid waħdu (bħal gleptoferron) fit-tielet jum wara t-twelid.
English: It is given as a single injection into the muscle behind the ear of piglets between 48 and 72 hours old.
Maltese: Jingħata bħala injezzjoni waħda fil-muskolu wara l-widna ta' qżieqeż li jkollhom bejn 48 u 72 siegħa.
English: Toltrazuril is an antiparastic medicine which interferes with the enzymes needed by coccidia parasites to produce energy.
Maltese: It-toltrażuril hija mediċina antiparassitika li tinterferixxi mal-enzimi meħtieġa mill-parassiti koċċidja biex jipproduċu l-enerġija.
English: What are the risks associated with Baycox Iron?
Maltese: X'inhuma r-riskji assoċjati ma' Baycox Iron?
English: Baycox Iron contains the active substances toltrazuril and gleptoferron (an iron-containing compound).
Maltese: Baycox Iron fih is-sustanzi attivi toltrażuril u gleptoferron (kompost li fih il-ħadid).
English: The other active substance in Baycox Iron, gleptoferron, is an iron-containing compound.
Maltese: Is-sustanza attiva l-oħra f'Baycox Iron, il-gleptoferron, hija kompost li fih il-ħadid.
English: Infected piglets shed disease spores (oocysts) in their faeces that can spread the infection.
Maltese: Qżieqeż infettati jwaqqgħu spori tal-mard (ooċisti) fl-ippurgar tagħhom li jistgħu jferrxu linfezzjoni.
English: Baycox Iron must not be given to piglets suspected to have insufficient levels of vitamin E or selenium.
Maltese: Baycox Iron ma għandux jingħata lill-qżieqeż li huwa ssuspettat li għandhom livelli insuffiċjenti ta' vitamina E jew selenju.
English: For the full list of side effects and restrictions of Baycox Iron, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Baycox Iron, ara l-fuljett ta' tagħrif.
English: Baycox Iron is also used to reduce spread of the infection through passage of oocysts in faeces, and at the same time to prevent iron deficiency anaemia due to the limited iron reserves of new-born piglets, low iron content of milk and high growth rate of suckling piglets.
Maltese: Baycox Iron jintuża wkoll biex jitnaqqas it-tixrid tal-infezzjoni permezz tal-passaġġ talooċisti fil-feċi, u fl-istess ħin biex tiġi evitata l-anemija kkawżata mid-defiċjenza tal-ħadid minħabba rriżervi limitati ta' ħadid tal-qżieqeż tat-twelid, kontenut baxx ta' ħadid tal-ħalib u rata għolja ta' tkabbir ta' qżieqeż mhux miftuma.
English: The withdrawal period for meat from pigs treated with Baycox Iron is 53 days.
Maltese: Il-perjodu ta' tiżmim għal-laħam minn qżieqeż ikkurati b'Baycox Iron huwa ta' 53 jum.
English: People who are hypersensitive (allergic) to iron compounds or toltrazuril should avoid contact with Baycox Iron.
Maltese: Persuni li huma ipersensittivi (allerġiċi) għall-komposti tal-ħadid jew għat-toltrażuril għandhom jevitaw il-kuntatt ma' Baycox Iron.
English: The most common side effects with Baycox Iron (which may affect up to 1 in 10 piglets) are short-lived tissue discolouration and slight swelling at the injection site.
Maltese: L-effetti sekondarji l-aktar komuni b'Baycox Iron (li jistgħu jaffettwaw mhux aktar minn qażquż 1 minn kull 10) huma skulurazzjoni ta' tessuti b'ħajja qasira u nefħa żgħira fis-sit tal-injezzjoni.
English: Baycox Iron (toltrazuril/gleptoferron)
Maltese: Għalfejn Baycox Iron ġie awtorizzat fl-UE?
English: Camino Labiano 45B 31192 Mutilva Alta,
Maltese: Camino Labiano 45B 31192 Mutilva
English: Czech Republic Geiser Pharma, S.L.
Maltese: Geiser Pharma, S.L.
English: Flurbiprofeno Geiser 8,75 mg/dosis solución para pulverización bucal
Maltese: Flurbiprofeno Geiser 8,75 mg/dosis solución para pulverización bucal Flurbiprofeno Geiser 8,75 mg/dosis solución para pulverización bucal
English: Member State EU/EEA
Maltese: Ir-Repubblika Slovakka
English: Flurbiprofen Sejmet 8,75 mg orálna roztoková aerodisperzia
Maltese: Flurbiprofen Sejmet 8,75 mg orálna roztoková aerodisperzia Flurbiprofen Sejmet 8,75 mg orálna roztoková aerodisperzia
English: Flurbiprofen Sejmet 8,75 mg keelspray
Maltese: Flurbiprofen Sejmet 8,75 mg keelspray Flurbiprofen Sejmet 8,75 mg keelspray
English: Mayne Pharma (Deutschland) GmbH D-85540 Haar
Maltese: Mayne Pharma (Deutschland) GmbH D-85540
English: • Persistent diarrhoea
Maltese: • Dijarea persistenti
English: • Severe anaemia
Maltese: • Anemija severa
English: EU/1/99/113/001 for 30 mg/5 ml EU/1/99/113/002 for 150 mg/25 ml EU/1/99/113/003 for 100 mg/16.7 ml EU/1/99/113/004 for 300 mg/50 ml
Maltese: EU/1/99/113/001 għal 30 mg/5 ml EU/1/99/113/002 għal 150 mg/25 ml EU/1/99/113/003 għal 100 mg/16.
English: Each infusion contains up to 21 g of alcohol.
Maltese: Kull infużjoni fiha sa 21 g ta' alkoħol.
English: Very rare*: atrial fibrillation
Maltese: Rari ħafna*: fibrillazzjoni atrijali
English: IVAX Scandinavia AB Tlf.
Maltese: IVAX Scandinavia AB
English: London E16 2QJ United Kingdom
Maltese: London E16 2QJ Ir-Renju Unit
English: The active substance of Paxene is paclitaxel.
Maltese: Is-sustanza attiva ta' Paxene hija paclitaxel.
English: Advanced non-small cell lung carcinoma
Maltese: Karċinoma non-small cell lung avvanzata
English: • Pale skin
Maltese: • Ġilda pallida
English: Paraesthesia was observed in 48 % of patients.
Maltese: Il-parasteżija ġiet osservata fi 48 % tal-pazjenti.
English: Combination therapy
Maltese: Terapija Kombinata
English: Nervous system disorders
Maltese: Disturbi psikjatriċi Disturbi fis-sistema nervuża
English: Clearance was 20.6 l/h/m2 (range 11 - 38) and the volume of distribution was 291 l/m2 (range 121 - 638).
Maltese: Ir-rata tal-eliminazzjoni kienet ta' 20.6 l/h/m2 (medda ta' bejn 11-38) u l-volum ta' distribuzzjoni kien ta' 291 l/m2 (medda 121 - 638).
English: Of the 107 patients, 63 patients were considered resistant to liposomal anthracyclines.
Maltese: Mill-107 pazjenti, 63 pazjent kienu kkonsidrati reżistenti għal anthracyclines liposomali.
English: Paxene contains alcohol.
Maltese: Paxene fih l-alkoħol.
English: Paxene is contraindicated during lactation.
Maltese: Paxene huwa kontraindikat waqt l-irdigħ.
English: Several metabolites have been detected, but only three of them have been identified: 6 alpha-hydroxypaclitaxel, 3'-para-hydroxypaclitaxel and 6 alpha, 3'-para-dihydroxypaclitaxel.
Maltese: 6 alphahydroxypaclitaxel, 3'-para-hydroxypaclitaxel u 6 alpha, 3'-para-dihydroxypaclitaxel.
English: • Balance problems
Maltese: • Problemi fil-bilanċ
English: Pharmacotherapeutic group: taxanes, ATC code: L01CD01.
Maltese: Kategorija farmakoterapewtika: taxanes, Kodiċi ATC:
English: Date of latest renewal: 19th July 2009
Maltese: Data tal-aħħar tiġdid: 19 ta' Lulju 2009.
English: Half to one hour before your infusion you will be given two different types of injection (an antihistamine and an H2 antagonist).
Maltese: Minn nofs siegħa sa siegħa qabel l-infużjoni ser tingħata żewġ tipi differenti ta' injezzjoni (antihistamine u antagonista H2).
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u nutrizzjoni
English: Paxene contains polyoxyl castor oil, which can cause an allergic reaction.
Maltese: Paxene fih polyoxyl castor oil, li jista' jikkaġuna reazzjoni allerġika.
English: Common: tachycardia, palpitation, bradycardia, syncope
Maltese: Komuni: takikardja, palpitazzjoni, bradikardja, sinkope.
English: Anaemia (Hb < 11 g/dL) was observed in 61 % of patients and was severe (Hb < 8 g/dL) in 10 %.
Maltese: L-anemija (Hb <11 g/dl) ġiet osservata f'61 % tal-pazjenti u kienet preżenti b'mod sever (Hb <8 g/dl) f'10 %.
English: Also contains: polyoxyl castor oil, citric acid (anhydrous) and 49.7 % (v/v) ethanol.
Maltese: Fih ukoll: polyoxyl castor oil, citric acid (anidru) u 49.7% (v/v) ethanol.
English: In vitro studies have shown that CYP 2C8 and 3A4 are involved in the formation of 6 alpha-hydroxypaclitaxel and 3'-para-dihydroxypaclitaxel, respectively.
Maltese: Fi studji in vitro ġie muri li CYP 2C8 u 3A4 huma involuti fil-formazzjoni ta' 6 alpha-hydroxypaclitaxel u 3'-para-dihydroxypaclitaxel, rispettivament.
English: 6 alpha-hydroxypaclitaxel is the major component excreted in faeces.
Maltese: 6 alphahydroxypaclitaxel huwa l-komponent ewlieni eliminat fl-ippurgar.
English: Uncommon: congestive heart failure, cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigeminy, AV block and syncope, myocardial infarction
Maltese: Mhux komuni: insuffiċjenza tal-qalb konġestiva, kardjomijopatija, takikardja ventrikulari asimptomatika, takikardja b'biġemini, Blokk AV u sinkope, infart mijokardijaku
English: Neutropenic fever related to Paxene was reported in 14 % of patients.
Maltese: Id-deni newtropeniku relatat ma' Paxene kien rapportat f'14 % tal-pazjenti.
English: Very rare*: bowel obstruction, bowel perforation, pseudomembranous colitis, ischemic colitis, mesenteric thrombosis, necrotising enterocolitis, oesophagitis, ascites, acute pancreatitis
Maltese: Rari ħafna*: sadd tal-imsaren, imsaren ipperforati, kolite psewdomembranja, kolite iskemika, trombosi meżenterika, eneterokolite nekrotizzanti, esofagite, axxite, pankreatite
English: Among patients (> 50 % on protease inhibitors) with normal baseline liver function, 28 %, 43 % and 44 % had elevations in bilirubin, alkaline phosphatase and AST (SGOT), respectively.
Maltese: Fost il-pazjenti (>50 % ta' impedituri ta' protease) li kellhom livell normali ta' referenza bażi għal funzjoni tal-fwied 28 %, 43 % u 44 % kellhom livelli ogħla ta' bilirubin, alkaline phosphatase u AST (SGOT) rispettivament.
English: 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), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1.000 sa <1/100); rari (≥1/10.000 sa <1/1.000); rari ħafna (<1/10.000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Since paclitaxel is metabolised by cytochrome P450 isoenzymes CYP 3A4 and 2C8, caution should be exercised with other medicinal products known to inhibit (e.g. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals) or induce (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine) these enzymes as they may affect the pharmacokinetics of paclitaxel.
Maltese: Billi paclitaxel huwa metabolizzat b'isoenzimi CYP 3A4 u 2C8 tas-cytochrome P450, attenzjoni għandha tingħata għal prodotti mediċinali oħrajn magħrufin li jimpedixxu (eż. erythromycin, fluoxetine, gemfibrozil, u antifungali ta' imidazole) jew li jissensittizzaw (eż. rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine) dawn l-enżimi billi jistgħu jaffetwaw il-farmakokinetika ta' paclitaxel.
English: The efficacy and safety of paclitaxel were evaluated in two major, randomised, controlled trials (vs. ciclophosphamide 750 mg/m2/ cisplatin 75 mg/m2).
Maltese: L-effikaċja u s-sigurtà ta' paclitaxel ġew evalwati f'żewġ provi kliniċi kbar, każwali u kkontrollati (vs ciclophosphamide 750 mg/m2/ cisplatin 75 mg/m2).
English: Very rare*: Stevens-Johnson syndrome, epidermal necrolysis, erythema multiforme, urticaria, onycholysis (patients on therapy should wear sun protection on hands and
Maltese: Rari ħafna: sindromu ta' Stevens-Johnson, nekroliżi epidermali, eritema multiforme, urtikarja, onikolożi (pazjenti fuq it-terapija għandhom jilbsu protezzjoni kontra x-xemx fuq l-idejn u r-riġlejn)
English: • are taking any other medicines prescribed by a physician for any condition (e.g. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals, rifampicin, carbamazepine, phenytoin, phenobarbital);
Maltese: • qed tieħu xi mediċini oħra mogħtija bir-riċetta mit-tabib tiegħek għal kwalunkwe kundizzjoni (eż. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals, rifampicin, carbamazepine, phenyton, phenobarbital);
English: Thrombocytopenia was observed in 50% of patients, and was severe (< 50,000 cells/mm3) in 9 %.
Maltese: It-tromboċitopenja kienet osservata f'50 % tal-pazjenti u kienet serja (<50,000 ċellula/mm3) f'9 % minnhom.
English: The following is a recommended pre-medication regimen: dexamethasone (8 - 20 mg) given orally (12 and 6 hours) or intravenously (30 - 60 mins) prior to Paxene, chlorpheniramine 10 mg intravenously or an equivalent antihistamine 30 to 60 minutes before Paxene and cimetidine (300 mg) or ranitidine (50 mg) intravenously 30 to 60 minutes before Paxene.
Maltese: Reġimen rakkomandat li jista' jingħata huwa: dexamethasone (8-20 mg) mogħti mill-ħalq (12-il siegħa u 6 sigħat) jew minn ġol-vina (30-60 minuta) qabel Paxene, chlorpheniramine 10 mg mogħti ġol-vina jew xi antiistamin ekwivalenti mogħti minn 30 sa 60 minuta qabel Paxene u cimetidine (300 mg) jew rantidine (50 mg) ġol-vina mogħti minn 30 sa 60 minuta qabel Paxene.
English: • Advanced non-small cell lung cancer if potentially curative surgery and/or radiation therapy are not possible, in combination with cisplatin.
Maltese: • Kanċer non-small cell lung (NSCLC) avvanzat jekk il-kura kirurġika u/jew terapija ta' radjazzjoni, mhumiex possibbli, u tingħata flimkien ma' cisplatin.
English: Thrombocytopenia was observed in 6 % of patients.
Maltese: Tromboċitopenija ġiet osservata f'6 % tal-pazjenti.
English: Severe hepatic impairment.
Maltese: Indeboliment epatiku serju.
English: Paxene is indicated for the treatment of patients with: - advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy; - metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy; - advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment; - metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment; - non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin.
Maltese: Paxene huwa intiż għal kura ta' pazjenti b': - sarkoma ta' Kaposi avvanzata, relatata mal-AIDS (KS-AIDS) f'każijiet fejn terapija liposomali b'anthracycline ma tkunx ħadmet fuqhom; - karċinoma fl-istadju metastatiku fis-sider (MBC) li ma tikkwalifikax għal terapija standard li fiha anthracycline jew f'każijiet fejn din il-kura ma tkunx ħadmet; - karċinoma tal-ovarju avvanzata (AOC) jew bi fdal marradi (> 1 ċm) wara laparotomija tal-bidu, flimkien ma' cisplatin bħala l-kura preferuta; - karċinoma fl-istadju metastatiku fl-ovarju (MOC) meta t-terapija kombinata li fiha platinu mingħajr taxanes ma tkunx ħadmet, bħala t-tieni kura preferuta; _ karċinoma non-small cell lung (NSCLC) li ma tikkwalifikawx għal kirurġija li hija potenzjalment kurattiva u/jew terapija ta' radjazzjoni, u tingħata flimkien ma' cisplatin.
English: Grade 2 or 3 peripheral neurotoxicity was observed more commonly with cisplatin/paclitaxel (29 % vs. 6 %).
Maltese: In-newrotossiċità periferali ta' Grad 2 jew 3 kienet osservata b'mod aktar komuni b'cisplatin/paclitaxel (29 % vs 6 %).
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website tal-Aġenzija Ewropea dwar il-Mediċini (EMEA) http://www.emea.europa.eu/
English: Cardiac conduction abnormalities and arrhythmias
Maltese: Abnormalitajiet fit-trasmissjoni kardijaka u arritmiji
English: Neutropenia was present for > 7 days in 41 % and for 30 - 35 days in 8 % of patients.
Maltese: In-newtropenja kienet preżenti għal >7 ijiem f'41 % u għal 30 - 35 jum fi 8 % tal-pazjenti.
English: Baseline neutrophil count < 1,500 cells/mm3 (< 1,000 cells/mm3 for AIDS-KS).
Maltese: Għadd ta' newtrofili fil-linja ta' riferiment bażi < 1,500 ċellula/mm3 (< 1, 000 ċellula/mm3 għal pazjenti b'AIDS-KS) .
English: Very rare*: confusional state
Maltese: Rari*: eritema
English: Paxene is a clear, colourless to slightly yellow, thickish solution that comes in vials containing 5 ml, 16.7 ml, 25 ml and 50 ml of concentrate.
Maltese: Paxene huwa soluzzjoni densa ċara, mingħajr kulur li tkanġi fl-isfar ċar, li tiġi f'kunjetti li fihom 5 ml, 16.7 ml, 25 ml u 50 ml konċentrat.
English: Medis, d.o.o Tel: + 386 1 589 69 00
Maltese: Tel: + 386 1 589 6900
English: Very common: severe neutropenia, severe leucopenia, thrombocytopenia, anaemia, myelosuppression Common: neutropenic fever Uncommon: severe anaemia Very rare*: acute myeloid leukaemia, myelodysplastic syndrome
Maltese: Komuni ħafna: newtropenja severa, lewkopenja severa, tromboċitopenija, anemija, majelosoppressjoni Komuni: deni newtropeniku Mhux komuni: anemija severa Rari ħafna*:lewkimja majelojde akuta, sindromu majelodisplastika
English: Carcinogenesis, mutagenesis, impairment of fertility Paclitaxel has been shown to be genotoxic in vivo (micronucleus test in mice), but it did not induce mutagenicity in the Ames test or the Chinese hamster ovary/hypoxanthine-guanine phosphoribosyl transferase (CHO/HGPRT) gene mutation assay.
Maltese: Paclitaxel intwera li hu ġenotossiku in vivo (test mikronucleju fil-ġrieden), imma ma ssensittizzax mutaġeniċità fit-test ta' Ames jew fl-assaġġ ta' mutazzjoni fil-ġene ta' hypoxanthine-guanine phosphoribosyl transferase fl-ovarju tal-ħamster Ċiniż.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Polyoxyl castor oil
Maltese: 6.1 Lista ta' sustanzi mhux attivi
English: • Vision disturbances
Maltese: • Disturbi fil-vista
English: AIDS-related Kaposi's sarcoma
Maltese: Sarkoma ta Kaposi relatata mal-AIDS
English: • Effects on the nerves controlling your muscles resulting in weakness in the arms and legs
Maltese: • Effetti fuq in-nervi li jikkontrollaw il-muskoli li jikkaġuna debbulizza fid-dirgħajn u r-riġlejn
English: Arthralgia was reported in 32 % of all patients (5 % severe) and myalgia in 47 % (6 % severe).
Maltese: L-artralġja kienet irrappurtata f'32 % tal-pazjenti kollha (5 % severi) u l-majalġja f'47 % (6 % severi).
English: • Severe skin irritation, lesions and rash
Maltese: • Irritazzjoni severa tal-ġilda, ġrieħi u raxx
English: Uncommon: severe infections, septic shock Rare*: pneumonia
Maltese: Mhux komuni: infezzjonijiet severi, xokk settiku Rari*: pnewmonja
English: Anaemia (Hb< 11 g/dl) was observed in approximately 9 % of treated patients but was severe in less than 1 % (Hb< 8 g/dl).
Maltese: L-anemija (Hb<11 g/dl) ġiet osservata f'madwar 9 % tal-pazjenti kkurati imma kienet preżenti b'mod sever f'inqas minn 1 % (Hb<8 g/dl).
English: Stabilisation results in the inhibition of the normal dynamic reorganisation of the microtubular network that is essential for vital interphase and mitotic cellular functions.
Maltese: L-istabilizzazzjoni tirriżulta fl-impediment tar-reorganizzazzjoni dinamika tax-xibka mikrotubulari li hi meħtieġa għal funzjonijiet ta' interfażi vitali u ċellulari mitotiċi.
English: • Acute leukaemia (blood cancer)
Maltese: • Lewkemija akuta (kanċer tad-demm)
English: Formal clinical drug interaction studies have not been performed with Paxene.
Maltese: Studji formali ta' interazzjoni klinika fuq id-droga ma twettqux b'Paxene.
English: Since Paxene contains ethanol, consideration should be given to possible central nervous system and other effects.
Maltese: Peress li Paxene fih l-alkoħol, konsiderazzjoni għandha tingħata għal effetti oħra possibbli fuq is-sistema nervuża ċentrali.