FrancophonIA/ELRC3.0 huggingface dataset:
English: In a clinical trial performed in healthy volunteers and adult males with mild erectile dysfunction, the daily administration of avanafil 100 mg oral doses over a period of 26 weeks was not associated with any untoward effects on sperm concentration, count, motility, or morphology .
Maltese: Fi prova klinika li saret f'voluntiera b'saħħithom u irġiel adulti b'disfunzjoni erettili ħafifa, l-għoti ta' dożi orali kuljum ta' avanafil 100 mg fuq perjodu ta' 26 ġimgħa ma kienx assoċjat ma xi effett mhux mistenni u mhux xieraq fuq il-konċentrazzjoni, l-għadd, il-motilità u l-morfoloġija tal-isperma.
English: In a patient who has taken avanafil within 12 hours, where nitrate administration is deemed medically necessary in a lifethreatening situation, the likelihood of a significant and potentially dangerous drop in blood pressure is increased.
Maltese: F'pazjent li jkun ħa avanafil fl-aħħar 12-il siegħa, meta l-għoti ta' nitrat ikun meqjus medikament neċessarju f'sitwazzjoni ta' periklu għall-ħajja, il-probabbiltà ta' tnaqqis sinifikanti u potenzjalment perikoluż fil-pressjoni taddemm tiżdied.
English: No cases were reported during clinical trials of avanafil.
Maltese: Ma kinux irrappurtati każijiet matul il-provi kliniċi b'avanafil.
English: Spedra is a pale yellow oval tablet, marked “200” on one side.
Maltese: Spedra huwa pillola ovali safra ċara, immarkata b'“200” fuq naħa waħda.
English: The tablets are provided in perforated unit dose blister packs containing 2x1, 4x1, 8x1, or 12x1 tablets.
Maltese: Il-pilloli jiġu f'folji b'sarbut toqob biex tinqata' doża waħda f'pakketti li fihom 2 pilloli x1, 4 pilloli x1, 8 pilloli x1, jew 12-il pillola x1.
English: Patients with left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure can be particularly sensitive to the actions of vasodilators including avanafil (see section 4.4).
Maltese: Pazjenti li jkollhom sadda fil--passaġġ 'il barra tal-ventrikolu tax-xellug (eż. stenożi aortika, stenożi subaortika ipertrofika idjopatika) u dawk b'indeboliment sever fil-kontroll awtonomu tal-pressjoni taddemm jistgħu jkunu partikolarment sensittivi għall-azzjonijiet ta' vażodilataturi fosthom avanafil (ara sezzjoni 4.4).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Maltese: Tagħrif mhux kliniku bbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva, ma juri l-ebda periklu speċjali għall-bnedmin.
English: Spedra is a pale yellow oval tablet, marked “50”on one side.
Maltese: Spedra huwa pillola ovali safra ċara, immarkata b'“50” fuq naħa waħda.
English: The repeated oral administration of avanafil 100 mg over a period of 26 weeks to healthy volunteers and adult males with mild erectile dysfunction was not associated with any untoward effects on sperm concentration, count, motility, or morphology.
Maltese: L-għoti ripetut mill-ħalq ta' avanafil 100 mg fuq perjodu ta' 26 ġimgħa lil voluntiera b'saħħithom u rġiel b'disfunzjoni erettili ħafifa ma kienx assoċjat ma xi effett mhux mistenni u mhux xieraq fuq ilkonċentrazzjoni, l-għadd, il-motilità u l-morfoloġija tal-isperma.
English: There were no treatment-related testicular findings in mice or rats treated with doses up to 600 or 1000 mg/kg/day for 2 years, and no testicular findings in dogs treated with avanafil for 9 months at exposures 110 times human exposure at the Maximum Recommended Human Dose (MRHD).
Maltese: Ma kienx hemm sejbiet testikulari relatati mal-kura fil-ġrieden jew fil-firien li rċevew kura b'dożi sa 600 jew 1000 mg/kg/jum għal sentejn, u l-ebda sejbiet testikulari fil-klieb li rċevew kura b'avanafil għal 9 xhur f'espożizzjoni 110 darbiet akbar mill-espożizzjoni umana fid-Doża Massima Rakkomandata fil-Bniedem (MRHD).
English: Patients with left ventricular outflow obstruction, e.g. aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators, including PDE5 inhibitors.
Maltese: Pazjenti li għandhom ostruzzjoni tal-passaġġ 'il barra talventrikolu tax-xellug, eż. stenożi aortika u stenożi subaortika ipertrofika idjopatika, jistgħu jkunu sensittivi għall-azzjoni tal-vażodilataturi, inklużi l-inibituri ta' PDE5.
English: Pharmaprim AB Sími: +46 8355933
Maltese: Sími: +46 8355933
English: • muscle aches or pains
Maltese: • tħossok stramb
English: • If you suffer from priapism, that is a persistent erection lasting 4 hours or more.
Maltese: • Jekk tbati minn prijapiżmu, jiġifieri erezzjoni persistenti li ddum 4 sigħat jew aktar.
English: Avanafil has no effect in the absence of sexual stimulation.
Maltese: Avanafil ma jkollux effett jekk ma jkunx hemm stimulazzjoni sesswali.
English: In particular, tell your doctor and do not take Spedra if you are taking “nitrate” medicines for chest pain (angina) such as amyl nitrite or glyceryl trinitrate.
Maltese: B'mod partikolari, għid lit-tabib tiegħek u tiħux Spedra jekk qed tieħu mediċini “nitrati” għal uġigħ fis-sider (anġina) bħal amyl nitrite jew glyceryl trinitrate.
English: MARKETING AUTHORISATION HOLDER MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. 1, Avenue de la Gare, L-1161, Il-Lussemburgu Il-Lussemburgu
English: Also do not take Spedra if you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir or if you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see beginning of section 2 under ‘Do not take Spedra').
Maltese: Barra minn hekk, ma għandekx tieħu Spedra jekk qed tieħu mediċini għall-HIV jew l-AIDS bħal ritonavir, indinavir, saquinavir, nelfinavir jew atazanavir jew jekk qed tieħu mediċini għal infezzjonijiet fungali bħal ketoconazole, itraconazole jew voriconazole jew ċerti antibijotiċi għal infezzjonijiet batteriċi, bħal clarithromycin jew telithromycin (ara l-bidu ta' sezzjoni 2 taħt ‘Tiħux Spedra').
English: Patients should be advised that concurrent use of avanafil and alcohol may increase the likelihood of hypotension, dizziness, or syncope.
Maltese: Il-pazjenti għandhom jiġu avżati li l-użu ta' avanafil flimkien mal-alkoħol jista' jżid il-probabbiltà ta' ipotensjoni, sturdament, jew sinkope.
English: Although specific interactions have not been studied, other CYP3A4 inhibitors, including grapefruit juice would likely increase avanafil exposure.
Maltese: Għalkemm ma ġewx studjati interazzjonijiet speċifiċi, inibituri oħra ta' CYP3A4, inkluż il-meraq talgrapefruit x'aktarx iżidu l-espożizzjoni għal avanafil.
English: Spedra is a pale yellow oval tablet, marked “100” on one side.
Maltese: Spedra huwa pillola ovali safra ċara, immarkata b'“100” fuq naħa waħda.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP) L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fir-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tar-RMP.
English: PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine.
Maltese: Inibituri ta' PDE5 intwerew li jżidu l-effetti ta' tnaqqis fil-pressjoni ta' din il-mediċina.
English: Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil.
Maltese: Tużax Spedra flimkien ma' kura oħra għad-disfunzjoni erettili bħal sildenafil, tadalafil jew vardenafil.
English: Avanafil is rapidly absorbed after oral administration, with a median Tmax of 30 to 45 minutes.
Maltese: Avanafil jiġi assorbit malajr wara l-għoti orali, b'Tmax medjan ta' nofs siegħa għal 45 minuta.
English: Dizziness Somnolence Sinus headache
Maltese: • uġigħ fl-istonku jew ħruq ta' stonku
English: This is thought to result from the combined effects of nitrates and avanafil on the nitric oxide/cGMP pathway.
Maltese: Dan huwa maħsub li jirriżulta mill-effetti kombinati tan-nitrati u avanafil fuq ir-rotta talossidu nitriku/cGMP. Għalhekk, l-għoti ta' avanafil lil pazjenti li jkunu qed jużaw xi forma ta' nitrat organiku jew donatur tal-ossidu nitriku (bħal amyl nitrite) huwa kontraindikat.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-folja u l-kartuna wara “JIS”.
English: Effects of other substances on avanafil
Maltese: Effetti ta' sustanzi oħra fuq avanafil
English: Rhinorrhoea Upper respiratory tract congestion
Maltese: Kif jidher Spedra u l-kontenut tal-pakkett
English: amiodarone or sotalol
Maltese: Tfal u adolexxenti
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Maltese: Il-frekwenzi għal avanafil mhumiex magħrufa.
English: Abdominal pain lower Diarrhoea
Maltese: Danmark Pharmaprim AB
English: • feeling dizzy
Maltese: • uġigħ fid-dahar
English: These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors.
Maltese: Dawn l-avvenimenti, li jistgħu jkunu akkumpanjati minn żarżir fil-widnejn u sturdament, ġew irrapportati b'rabta temporanja mat-teħid ta' inibituri ta' PDE5.
English: Pharmacotherapeutic group: Urologicals: Drugs used in erectile dysfunction.
Maltese: Ilfarmakokinetika tiegħu hija proporzjonali mad-doża fuq il-medda rakkomandata tad-doża.
English: In a rat pre- and post-natal development study, pups exhibited persistent decreases in body weight at 300 mg/kg/day and higher (approximately 15 times the MRHD on a mg/m basis) and delayed sexual development at 600 mg/kg/day (approximately 29 times the MRHD on a mg/m basis).
Maltese: Fi studju dwar l-iżvilupp qabel u wara t-twelid fuq il-firien, il-frieħ urew tnaqqis persistenti fil-piż talġisem b'doża ta' 300 mg/kg/jum u ogħla (madwar 15-il darba l-MRHD fuq bażi ta' mg/m2) u dewmien fl-iżvilupp sesswali b'doża ta' 600 mg/kg/jum (madwar 29 darba l-MRHD fuq bażi ta' mg/m
English: Dose adjustments are not required in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 mL/min).
Maltese: M'hemm bżonn tal-ebda aġġustament fid-doża f'pazjenti b'indeboliment fil-kliewi minn ħafif sa moderat (tneħħija tal-krejatinina ≥ 30 mL/min).
English: You could have been given the dose of one 200 mg tablet if your doctor has decided that the 100 mg dose was too weak for you, or the dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet was too strong for you.
Maltese: Jista' jkun li ngħatajt id-doża ta' pillola waħda ta' 200 mg jekk it-tabib tiegħek iddeċieda li d-doża ta' 100 mg kienet ħafifa wisq għalik, jew id-doża ta' pillola waħda ta' 50 mg jekk it-tabib tiegħek iddeċieda li l-pillola ta' 100 mg kienet qawwija wisq għalik.
English: There was a statistically significant difference in maximum decrease from baseline in supine diastolic blood pressure with enalapril and avanafil only, which returned to baseline 4 hours after the dose of avanafil.
Maltese: Kien hemm differenza statistikament sinifikanti fit-tnaqqis massimu mil-linja bażi fil-pressjoni dijastolika tad-demm meta l-pazjent kien mimdud fuq dahru b'enalapril u b'avanafil biss, li reġgħet lura għal-linja bażi 4 sigħat wara d-doża ta' avanafil.
English: 12 December 2018 EMA/778491/2018 EMEA/H/V/004291
Maltese: EMA/15583/2019 EMEA/H/V/004291
English: Longrange is a veterinary medicine that contains the active substance eprinomectin.
Maltese: Longrange huwa mediċina veterinarja li fiha s-sustanza attiva eprinomectin.
English: Refusal of the marketing authorisation for Longrange (eprinomectin)
Maltese: Longrange (eprinomectin)
English: Refusal of the marketing authorisation for Longrange (eprinomectin) EMA/778491/2018
Maltese: Rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq ta' Longrange (eprinomectin) EMA/15583/2019
English: Longrange was expected to be used to treat infections with the following parasites: gut roundworms, lungworm, warbles, mange mites, lice and horn flies.
Maltese: Longrange kien mistenni li jintuża biex jikkura infezzjonijiet bil-parasiti li ġejjin: roundworms talimsaren, lungworm, dubbiena tal-ġeneru Hypoderma, mange mites, qamel u horn flies.
English: After considering the grounds for this request, the CVMP re-examined the opinion and confirmed the refusal of the marketing authorisation on 11 October 2018.
Maltese: Wara li kkunsidra r-raġunijet għal din it-talba, is-CVMP reġa' eżamina lopinjoni u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq fil-11 ta' Ottubru 2018.
English: It was also expected to prevent reinfections with gut roundworms and lungworm for 100 to 120 days.
Maltese: Kien mistenni wkoll li jipprevjeni infezzjonijiet mill-ġdid b'roundworms tal-musrana u lungworms għal 100 sa 120 ġurnata.
English: The company presented data from a main field study of 156 young cattle with natural roundworm and/or lungworm infections that were treated with Longrange.
Maltese: Il-kumpanija ppreżentat data minn studju ewlieni fuq il-post ta' 156 baqra żgħira b'infezzjonijiet tarroundworm naturali u/jew b'infezzjonijiet tal-lungworms li ġew ikkurati b'Longrange.
English: The active substance in Longrange, eprinomectin, is a well-known antiparasitic substance that works by attaching to tiny pores on the surface of parasitic nerve or muscle cells called glutamate-gated chloride ion channels.
Maltese: Is-sustanza attiva f'Longrange, eprinomectin, hija sustanza antiparassitika magħrufa sew li taħdem billi titwaħħal ma' pori żgħar fuq il-wiċċ tan-nerv parassitiku jew taċ-ċelloli tal-muskoli msejħa kanali taljoni tal-klorur miksija bil-glutamat.
English: On 21 June 2018, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Longrange, intended for the treatment and prevention of parasitic infections in cattle.
Maltese: Fil-21 ta' Ġunju 2018, il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Longrange, maħsub għall-kura u l-prevenzjoni ta' infezzjonijiet parassitiċi fil-frat.
English: What is Longrange?
Maltese: X'inhu Longrange?
English: What was Longrange expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Longrange?
English: The company that applied for authorisation is Merial.
Maltese: Il-kumpanija li applikat għal awtorizzazzjoni hija Merial.
English: The CVMP was concerned mainly about the possible effects of Longrange on the environment, specifically its effects on organisms in cattle dung.
Maltese: Is-CVMP kien imħasseb prinċipalment dwar l-effetti possibbli ta' Longrange fuq l-ambjent, speċifikament l-effetti tiegħu fuq l-organiżmi fid-demel tal-frat.
English: The company also presented data on the effectiveness of Longrange against ectoparasites - those parasites such as lice and warble flies that live on the outside of the animal's body.
Maltese: Il-kumpanija ppreżentat ukoll data dwar l-effikaċja ta' Longrange kontra l-ektoparassiti - dawk ilparassiti bħall-qamel u d-dubbien tal-ġeneru Hypoderma li jgħixu fuq barra tal-ġisem tal-annimal.
English: This leads to an increase in the amount of chloride ions that enter the cells, resulting in paralysis and death of the parasite.
Maltese: Dan iwassal għal żieda fl-ammont ta' joni tal-klorur li jidħlu fiċċelloli, li jirriżulta fil-paraliżi u l-mewt tal-parassita.
English: This summary was last updated on: 04-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 04-2013.
English: Other information about Naxcel:
Maltese: Informazzjoni oħra dwar Naxcel:
English: This document is a summary of the European Public Assessment report for Naxcel.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropea (EPAR) għal Naxcel.
English: The active substance in Naxcel is ceftiofur, which belongs to a class of antibiotics called “third generation cephalosporins”.
Maltese: Is-sustanza attiva f'Naxcel hija ceftiofur, li tappartjeni għall-grupp ta' antibiotiċi msejħa “cephalosporins tat-tielet ġenerazzjoni”.
English: What is Naxcel?
Maltese: X'inhu Naxcel?
English: Why has Naxcel been approved?
Maltese: Għaliex ġie approvat Naxcel?
English: Naxcel has been investigated in pigs with respiratory diseases caused by various bacteria or in pigs suffering from severe lameness, fever or other clinical signs of septicaemia, polyarthritis (inflammation of the joints) or polyserositis (inflammation of the internal body membranes) associated with Streptococcus suis infection.
Maltese: Naxcel ġie studjat f'majjali b'mard respiratorju kkawżat minn batterji varji jew f'majjali li jbatu minn zappip gravi, deni jew sinjali kliniċi oħrajn ta' septicaemia (infezzjoni fid-demm), poliartrite (infjammazzjoni tal-ġogi) jew poliserositie (infjammazzjoni tal-membrani interni tal-ġisem) assoċjati ma' infezzjonijiet ta' Streptococcus suis.
English: What is the risk associated with Naxcel?
Maltese: X'inhu r-riskju assoċjat ma' Naxcel?
English: Naxcel is an antibiotic suspension that contains ceftiofur (as crystalline free acid) as the active substance.
Maltese: Naxcel huwa suspensjoni antibijotika li fiha ceftiofur (bħala aċidu ħieles mill-kristalli) bħala s-sustanza attiva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Naxcel on 19 May 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Naxcel fid-19 ta' Mejju 2005.
English: If you want more information regarding the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni fuq il-bażi tar-rakkomandazzjonijiet tal-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: In pigs, the withdrawal period in meat and offal is 71 days.
Maltese: Għall-majjali, il-perijodu ta' rtirar għal-laħam u l-ġewwieni huwa ta' 71 jum.
English: Ceftiofur (like other cephalosporins or penicillins) may cause allergic reaction in humans or in animals, which may occasionally be serious.
Maltese: Ceftiofur (bħal cephalosporins oħra jew peniċillini) jista' jikkawża reazzjoni allerġika fil-bniedem jew flannimali, li okkażjonalment tista' tkun serja.
English: In cattle, Naxcel is used to treat foot rot (an infection of the feet) and acute puerperal metritis (an infection of the womb occurring after calving) in cases where treatment with another antimicrobial has failed.
Maltese: Fil-baqar, Naxcel jintuża għall-kura ta' mard fis-saqajn (bħal infezzjonijiet fis-sieq) u puerperal metritr gravi (infezzjoni tal-utru wara t-twelid) f'każijiet fejn il-kura ma' antimikrobidu ieħor tkun falliet.
English: All these cephalosporin antibiotics, including ceftiofur, kill bacteria by disrupting the building of the bacterial cell walls.
Maltese: Dawn l-antibiotiċi cephalosporin kollha, inkluż ceftiofur, joqtlu l-batterji billi jfixklu l-bini tal-ħajt taċ-ċelluli tal-batterji.
English: Data from laboratory studies with different bacteria showed that ceftiofur is effective against bacteria involved in causing the pig and cattle diseases listed above.
Maltese: Dejta minn studji fil-laboratorju b'batterji differenti wrew li ceftiofur huwa effettiv kontra l-batterji involuti fl-ikkawżar tal-mard tal-majjali u tal-baqar elenkati hawn fuq.
English: How has Naxcel been studied?
Maltese: Kif ġie studjat Naxcel?
English: Naxcel should be handled with care and all of the recommended precautions be taken to avoid exposure to the product.
Maltese: Naxcel għandu jiġi mmaniġġjat b'attenzjoni u għandhom jittieħdu l-prekawzjonijiet rakkomandati kollha sabiex tiġi evitata l-espożizzjoni għall-prodott.
English: Italia Zentiva Italia S.r.l.
Maltese: Italia S.r.l.
English: Czech Republic
Maltese: Česká republika
English: Date of last renewal: 20 April 2012
Maltese: Data tal-aħħar tiġdid: 20 ta' April 2012
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD02
Maltese: Taxanes, Kodiċi ATC: L01CD 02
English: Tumour response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Maltese: 95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA:
English: Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Czech Republic
Maltese: Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Ir-Repubblika Ċeka
English: An updated RMP shall be submitted by 31 October 2019.
Maltese: RMP aġġornat għandu jiġi sottomess sal-31 ta 'Ottubru 2019.
English: Cisplatin and 5-fluorouracil
Maltese: cisplatin u 5-fluorouracil.
English: The ORR was 59.3% (95% CI: 52.8 - 65.9) in AT arm versus 46.5% (95% CI: 39.8 - 53.2) in AC arm.
Maltese: Ir-RTTR kienet 59.3% (95% CI: 52.8 - 65.9) fil-fergħa AT versu 46.5% (95% CI: 39.8 - 53.2) fil-fergħa AC.
English: Respiratory disorders
Maltese: Disturbi respiratorji,
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval
Maltese: TAC = docetaxel, doxorubicin u cyclophosphamide FAC = 5-fluorouracil, doxorubicin u cyclophospamide CI = confidence interval; RE = riċettur tal-estroġenu
English: For the full list of excipients, see section 6.1.
Maltese: Għall-lista kompluta ta'eċċipjenti, ara sezzjoni 6.1.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 April 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' April 2007
English: Ethanol anhydrous
Maltese: Ethanol anhydrous Citric Acid
English: Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Maltese: Kull kunjett ta' konċentrat fih 2ml ta ethanol anhydrous (1.58 g).
English: Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Maltese: Kull kunjett ta' konċentrat fih 0.5ml ta ethanol anhydrous (395mg).
English: Docetaxel Zentiva contains ethanol (alcohol)
Maltese: Docetaxel Zentiva fih l-ethanol (l-alkoħol)
English: Acute leukaemia / Myelodysplastic syndrome.
Maltese: Lewkimja akuta/ Sindrome ta' majilodisplastik.
English: • 545 patients (STAMPEDE study) who received docetaxel in combination with prednisone or prednisolone and ADT.
Maltese: • 545 pazjent (studju STAMPEDE) li rċivew docetaxel flimkien ma' prednisone jew prednisolone u ADT.
English: Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Maltese: Insuffiċjenza tal-qalb sintomatika kienet irrapportata f'2.2% tal-pazjenti li ħadu Docetaxel Zentiva flimkien ma' trastuzumab meta mqabbel ma' 0% tal-pazjenti li ngħataw Docetaxel Zentiva wahdu.
English: However, the distribution of OS was not significantly different between the 2 groups.
Maltese: III li huma inqas iddifferenzjati.
English: Grade 2
Maltese: Grad 2 Grad 3
English: The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8).
Maltese: inċidenza ta' newtropenja ta' Grad 4, newtropenja bid-deni u infezzjoni newtropenika naqset filpazjenti li rċevew il-prevenzjoni primarja permezz ta' G-CSF (ara sezzjoni 4.8).