FrancophonIA/ELRC3.0 huggingface dataset:
English: Pregnancies have been reported in rather high numbers in the clinical trial program raising concerns with regard to the teratogenic risk of the product when used in a less controlled real life setting.
Maltese: Tqala ġiet irrapportata f'numru pjuttost għoli fil-programm ta' provi kliniċi li qajjem tħassib rigward ir-riskju teratoġeniku tal-prodott meta jintuża f'sitwazzjoni tal-ħajja reali inqas ikkontrollata.
English: Reduction of weight can be assumed as surrogate parameter for a beneficial cardiovascular (CV) outcome and current EMA guidance on medicinal products used in weight control does not require demonstration of a positive effect on CV morbidity and mortality prior to approval.
Maltese: Ittnaqqis tal-piż jista' jitqies bħala parametru ta' sostituzzjoni għal eżitu kardjovaskolari (KV) ta' benefiċċju u l-gwida attwali tal-EMA dwar il-prodotti mediċinali użati għall-kontroll tal-piż ma teħtieġx wirja ta' effett pożittiv fuq il-morbidità KV u l-mortalità qabel tingħata l-approvazzjoni.
English: Therefore, the lack of power, and thus reliability, of the post-hoc analysis of cardiovascular events during the Qsiva clinical development program remains a major concern, since with a total number of 1526 patients of low CV risk treated for one year the expected rate of CV events is extremely low and thus of little significance for the assessment of the CV risk.
Maltese: Għaldaqstant, in-nuqqas ta' saħħa, u b'hekk tal-affidabbiltà, tal-analiżi post-hoc ta' avvenimenti kardjovaskolari matul il-programm ta' żvilupp kliniku ta' Qsiva jibqa' ta' tħassib kbir, billi b'għadd totali ta' 1526 pazjent b'riskju KV baxx ikkurati għal sena r-rata mistennija ta' avvenimenti
English: Topiramate is known as a teratogenic substance causing congenital malformations.
Maltese: Topiramate huwa magħruf bħala sustanza teratoġenika li tikkawża malformazzjonijiet konġenitali.
English: Outcomes using various accepted MACE composite endpoints in the Qsiva programme showed no increase in risk for any of these endpoints compared to placebo (hazard ratios <1.0).
Maltese: Eżiti li jużaw diversi punti ta' tmiem aċċettati b'komposti ta' MACE fil-programm ta' Qsiva ma wrew l-ebda żieda firriskju għal kwalunkwe wieħed minn dawn il-punti ta' tmiem meta mqabbla mal-plaċebo (proporzjonijiet ta' periklu <1.0).
English: Many of these adverse events were also reported with Qsiva as a fixed-dose combination of phentermine/topiramate in four pivotal Phase III studies and two supportive Phase II studies.
Maltese: Ħafna minn dawn l-effetti ħżiena kienu rrapportati wkoll bi Qsiva bħala kombinazzjoni ta' doża fissa ta' phentermine/topiramate f'erba' studji pivotali tal-Fażi III u żewġ studji ta' appoġġ tal-Fażi II.
English: During the re-examination procedure, the applicant proposed a further revised SmPC which forgoes the top dose of Qsiva, associated with the highest rate of psychiatric and cardiovascular adverse events.
Maltese: Matul il-proċedura ta' eżaminazzjoni mill-ġdid, l-applikant ippropona SmPC rivedut ulterjorment li jirrinunzja l-ogħla doża ta' Qsiva, assoċjata mal-ogħla rata ta' avvenimenti ħżiena psikjatriċi u kardjovaskolari.
English: The applicant further cited supportive CV safety data from published results of clinical studies with other sympathomimetic agents in other indications and from historical data with phentermine.
Maltese: L-applikant ikkwota wkoll dejta ta' sigurtà KV ta' appoġġ minn riżultati ppubblikati ta' studji kliniċi b'sustanzi simpatomimetiċi oħrajn f'indikazzjonijiet oħrajn u minn dejta storika dwar phentermine.
English: Cardiovascular safety - According to the applicant, the only concern about a potential increase in CV risk arises from a small (1.6 bpm) dose-related increase in heart rate that differed significantly from placebo only with the top-dose, but not for the mid-dose, whereas blood pressure was consistently and significantly reduced by both the mid- and top-doses of Qsiva.
Maltese: Sigurtà kardjovaskolari - Skont l-applikant, l-uniku tħassib rigward żieda potenzjali fir-riskju KV ġej minn żieda żgħira (1.6 bpm) relatata mad-doża fir-rata tal-qalb li kienet tvarja b'mod sinifikanti millplaċebo bl-ogħla doża biss, iżda mhux bid-doża tan-nofs, filwaqt li l-pressjoni tad-demm kienet imnaqqsa b'mod konsistenti u sinifikanti kemm bid-doża tan-nofs kif ukoll bid-doża għolja ta' Qsiva.
English: The collection of psychiatry data with screening instruments such as QPH-9 and C-SSRS was found by CHMP to be inadequate since diagnostic instruments are more powerful and would be needed to reliably establish the clinical relevance and magnitude of the psychiatry adverse events (AEs) observed with Qsiva.
Maltese: Is-CHMP sab li l-ġbir ta' dejta psikjatrika bi strumenti ta' skrining bħal QPH-9 u C-SSRS ma kienx adegwat biżżejjed peress li l-istrumenti dijanjostiċi għandhom aktar saħħa u jkunu meħtieġa sabiex wieħed jistabbilixxi b'mod affidabbli r-rilevanza klinika u l-kobor talavvenimenti ħżiena (AEs) psikjatriċi osservati bi Qsiva.
English: Obesity, including weight loss and maintenance of weight loss in adults, as an adjunct to reduced calorie diet and physical activity.
Maltese: L-obeżità, inkluż it-tnaqqis fil-piż u ż-żamma tat-tnaqqis fil-piż fl-adulti, bħala żieda ma' dieta ta' kaloriji mnaqqsa u attività fiżika.
English: Estimates of the mean heart rate were considered by CHMP not to be necessarily the most relevant parameter (compared to e.g. increase in heart rate in the highest percentile or increased proportion of subjects with > 10 bpm) The consequence of the sympathomimetic mechanism of action of Qsiva for CV outcome in long-term use remains a principle concern for CHMP in the absence of long-term CV outcome trial data.
Maltese: Is-CHMP qies li l-istimi tar-rata tal-qalb medja mhumiex neċessarjament l-aktar parametru rilevanti (meta mqabbel pereżempju maż-żieda fir-rata tal-qalb fl-ogħla perċentil jew żieda filproporzjon ta' suġġetti b'> 10 bpm)
English: Dropout rates for depression with Qsiva significantly outnumbered those with placebo; thus close surveillance in trials may have stopped progression to more severe symptoms.
Maltese: Ir-rati ta' persuni li waqfu mill-istudju minħabba depressjoni bi Qsiva kienu b'mod sinifikanti aktar numerużi minn dawk bil-plaċebo; b'hekk il-monitoraġġ mill-qrib fil-provi seta' waqqaf il-progress lejn sintomi aktar severi.
English: Another concern was the feasibility to exclude patients with moderate depression from treatment.
Maltese: Tħassib ieħor kien kemm huwa fattibbli li jiġu esklużi mill-kura pazjenti b'depressjoni moderata.
English: The probability of off-label use - A robust SmPC and state-of-the art education-based RMP, further strengthened by the use of comprehensive prescriber checklist and patient education card, was proposed to be put in place by the applicant to be uniformly and easily implementable across all EU countries.
Maltese: Il-probabbiltà ta' użu differenti minn dak fuq it-tikketta - l-applikant ippropona li jistabbilixxi SmPC sod u RMP ibbażat fuq edukazzjoni tal-ogħla livell, imsaħħin aktar bl-użu ta' lista ta' kontroll komprensiva għat-tobba u skeda edukattiva għall-pazjenti, sabiex dawn ikunu jistgħu jiġu implimentati mill-applikant b'mod uniformi u faċli fil-pajjiżi kollha tal-UE.
English: Following a request from the applicant at the time of the re-examination, the CHMP convened a Scientific Advisory Group (SAG) Diabetes Endocrinology with additional experts, inviting the experts to provide their views on the CHMP grounds for refusal, taking into account the applicant's response.
Maltese: Wara talba mill-applikant meta kienet qiegħda ssir l-eżaminazzjoni mill-ġdid, is-CHMP laqqa' Grupp Xjentifiku Konsultattiv (SAG) fl-Endikronoloġija tad-Dijabete flimkien ma' esperti addizzjonali, filwaqt li stieden lill-esperti sabiex jagħtu l-fehma tagħhom dwar ir-raġunijiet għal rifjut tas-CHMP, u filwaqt li jikkunsidraw ir-rispons tal-applikant.
English: Live attenuated Aujeszky's Disease Virus
Maltese: Virus ħaj inattivat tal-Marda Aujeszky
English: An increase in body temperature up to about 40.5°C can occur in a small number of pigs, lasting for up to two days.
Maltese: F'xi ftit mill-ħnieżer jista' jkun hemm żieda fit-temperatura sa madwar 40.5°C, li ddum sa jumejn.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni abbażi tar-rakkomandazzjonijiet tal-CVMP, aqra dDiskussjoni Xjentifika (parti wkoll mill-EPAR).
English: What is the withdrawal period?
Maltese: Il-withdrawal period hu żero jiem.
English: This summary was last updated in: 04-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fl-04-2013.
English: The virus has been genetically modified: it has had one of its gene deleted (the gene that makes it able to produce an enzyme called thymidine kinase) and this is what makes it weaker.
Maltese: Il-vajrus ikun ġie modifikat ġenetikament: tkun tneħħietlu l-ġene li tagħmlu kapaċi jipproduċi enzim magħruf bħala thymidine kinase) u huwa dan li jdgħajfu.
English: This can be up to 2 cm in diameter after first injection and up to 5 cm after the second, but they usually disappear within three weeks.
Maltese: Din jista' jkollha dijametru ta' mhux iktar minn 2 ċm wara l-ewwel injezzjoni u sa 5ċm wara t-tieni waħda, iżda ġeneralment jisparixxu fi żmien tliet ġimgħat.
English: Suvaxyn Aujeszky 783 + O/W was effective at preventing infection with the virus.
Maltese: Suvaxyn Aujeszky 783 + O/W kien effettiv fil-prevenzjoni ta' infezzjoni bil-vajrus.
English: The vaccine also contains ‘adjuvants' (a compound containing aluminium as well as mineral oil, an emulsifier and a detergent) to stimulate a better response.
Maltese: Il-vaċċin ikun fih ukoll ‘adjuvant' (kompost li jkun fih laluminju kif ukoll żejt minerali, emulsifikant u deterġent) biex jistimula rispons aħjar.
English: Suvaxyn Aujeszky 783 + O/W is a powder and solvent that are made up into an emulsion (a mixture of oil- and water-based liquids) for injection.
Maltese: Suvaxyn Aujeszky 783 + O/W hu trab u solvent li jitħalltu biex jifformaw emulsjoni (taħlita ta' likwidi b'bażi ta' ilma u żejt) għall-injezzjoni.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suvaxyn Aujeszky 783 + O/W exceed the risks for the treatment of active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky's Disease and to reduce the excretion of Aujeszky's Disease field virus.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Suvaxyn Aujeszky 783 + O/W jegħelbu r-riskji għall-immunizzazzjoni attiva u passiva tal-ħnieżer sabiex jipprevjeni jew inaqqas il-mortalità u s-sinjali kliniċi tal-marda ta' Aujeszky u biex inaqqas it-tixrid talvajrus tal-marda ta' Aujeszky.
English: Suvaxyn Aujeszky 783 + O/W is a vaccine.
Maltese: Suvaxyn Aujeszky 783 + O/W hu vaċċin.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: Informazzjoni dwar l-istejtus talpreskrizzjoni ta' dan il-prodott tista' tinstab fuq it-tikketta/ pakkett ta' barra.
English: What is Suvaxyn Aujeszky 783 + O/W?
Maltese: X'inhu Suvaxyn Aujeszky 783 + O/W?
English: Suvaxyn Aujeszky 783 + O/W is a vaccine that contains a live attenuated (weakened) form of Aujeszky's disease virus strain NIA3-783.
Maltese: Suvaxyn Aujeszky 783 + O/W huwa vaċċin li fih forma ħajja iżda dgħajfa tar-razza NIA3-783 tal-vajrus li jikkawża l-marda ta' Aujeszky.
English: Suvaxyn Aujeszky 783 + O/W is used to vaccinate pigs from the age of 10 weeks against Aujeszky's disease, an illness similar to rabies that is caused by a herpesvirus.
Maltese: Suvaxyn Aujeszky 783 + O/W jintuża għat-tlaqqim tal-ħnieżer mill-età ta' 10 ġimgħat kontra l-marda ta' Aujeszky, marda li tixbah lir-rabja li tiġi kkawżata minn herpesvirus.
English: Passive immunisation of the progeny of vaccinated gilts and sows to reduce mortality and clinical signs of Aujeszky's Disease and to reduce the excretion of Aujeszky's Disease field virus, and recommended that Suvaxyn Aujeszky 783 + O/W be given a marketing authorisation.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Suvaxyn Aujeszky 783 + O/W fl-7 ta' Awwissu 1998.
English: If pain persists for more than 12 hours after examination, seek medical advice again.
Maltese: Jekk l-uġigħ jippersisti għal iktar minn 12-il siegħa wara l-eżaminazzjoni, erġa' itlob parir mediku.
English: Pregabalin Sandoz GmbH is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Maltese: Pregabalin Sandoz GmbH jiġi bħala kapsuli (25, 50, 75, 100, 150, 200, 225 u 300 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: The full EPAR and risk management plan summary for Pregabalin Sandoz GmbH 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: Pregabalin Sandoz GmbH is a ‘generic medicine'.
Maltese: Pregabalin Sandoz GmbH huwa ‘mediċina ġenerika'.
English: The active substance in Pregabalin Sandoz GmbH, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Maltese: Is-sustanza attiva f'Pregabalin Sandoz GmbH, pregabalin, hija simili fl-istruttura għall-aċidu butriku talgamma-amino (GABA) ‘newrotrażmettitur' tal-ġisem stess, iżda għandu effetti bijoloġiċi differenti ħafna.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Sandoz GmbH.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pregabalin Sandoz GmbH.
English: Other information about Pregabalin Sandoz GmbH
Maltese: Informazzjoni oħra dwar Pregabalin Sandoz GmbH
English: Because Pregabalin Sandoz GmbH is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica.
Maltese: Billi Pregabalin Sandoz GmbH huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Lyrica.
English: Because Pregabalin Sandoz GmbH is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Pregabalin Sandoz GmbH huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: A risk management plan has been developed to ensure that Pregabalin Sandoz GmbH is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Pregabalin Sandoz GmbH jintuża bl-aktar mod sikur possibbli.
English: Why is Pregabalin Sandoz GmbH approved?
Maltese: Għaliex ġie approvat Pregabalin Sandoz GmbH?
English: This means that Pregabalin Sandoz GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Maltese: Dan ifisser li Pregabalin Sandoz GmbH jixbah lill‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Lyrica.
English: Pregabalin Sandoz GmbH
Maltese: Kif jintuża Pregabalin Sandoz GmbH?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Sandoz GmbH has been shown to have comparable quality and to be bioequivalent to Lyrica.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-Aġenzija kkonkluda li, skont irrekwiżiti tal-UE, intwera li Pregabalin Sandoz GmbH għandu kwalità komparabbli u huwa bijoekwivalenti għal Lyrica.
English: Pregabalin Sandoz GmbH is a medicine used to treat adults with the following conditions:
Maltese: Pregabalin Sandoz GmbH huwa mediċina li tintuża għat-trattament ta' adulti bil-kundizzjonijiet li ġejjin:
English: How has Pregabalin Sandoz GmbH been studied?
Maltese: Kif ġie studjat Pregabalin Sandoz GmbH?
English: How is Pregabalin Sandoz GmbH used?
Maltese: Kif jaħdem Pregabalin Sandoz GmbH?
English: What are the benefits and risks of Pregabalin Sandoz GmbH?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Pregabalin Sandoz GmbH?
English: • epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures
Maltese: • epilessija, fejn jintuża bħala ‘żieda' flimkien ma' kura eżistenti f'pazjenti li jbatu minn aċċessjoni parzjali (epilessija severa li tibda f'parti speċifika tal-moħħ) li ma tistax tiġi kkontrollata bil-kura li qed jieħdu fil-preżent;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Sandoz GmbH on 19 June 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Pregabalin Sandoz GmbH valida madwar l-Unjoni Ewropea kollha fid-19 ta' Ġunju 2015.
English: Magyarország Teva Gyógyszergyár Zrt.
Maltese: Magyarország Teva Gyógyszergyár Zrt Tel.:
English: Pliva Ljubljana d.o.o.
Maltese: Slovenija Pliva Ljubljana d.o.o.
English: Concentrate Polysorbate 80
Maltese: Polysorbate 80
English: 2003 RN Haarlem The Netherlands
Maltese: 2003 RN Haarlem l-Olanda
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 21st January 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 21 Jannar 2011
English: Statistical Analysis
Maltese: Analiżi statistika
English: 3542 DR Utrecht The Netherlands
Maltese: 3542 DR Utrecht l-Olanda
English: 99-300 Kutno
Maltese: 99-300 Kutno Il-Polonja
English: 95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
Maltese: 95% CI p-value* †Test ta' grad ta' log isstratifikat *Punt ta' riferiment għal sinifikat statistiku=0.0175 **PSA: Prostate-Specific Antigen - Antiġen speċifiku kontra l-prostata
English: 5.12 ml (Fill: 6.29 ml)
Maltese: 5.12 ml (Mili: 6.29 ml)
English: Hazard ratio 95% CI p-value†*
Maltese: 95% CI p-value*
English: 1.28 ml (Fill: 1.71 ml)
Maltese: 1.28 ml (Mili:1.71 ml)
English: Hazard ratio: 1.032 [95% CI: 0.876; 1.216]
Maltese: Riskju proporzjonali: 1.032 [95% CI: 0.876; 1.216]
English: Ethanol, anhydrous
Maltese: Ethanol, anidru
English: • oral candidiasis
Maltese: • kandidijasi orali
English: Paresthesia; Headache; Dysgeusia;
Maltese: Parasteżija; Ugigħ ta' ras; Disgewżja;
English: With primary G-CSF prophylaxis (n = 421) n (%)
Maltese: Bi profilassi primarja ta' G-CSF (n = 421) n (%)
English: - The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol.
Maltese: - Is-sustanza l-oħra hi polysorbate 80 u 25.1% (w/v) ethanol anidru.
English: Each ml of concentrate contains 27.73 mg docetaxel.
Maltese: Kull ml ta' konċentrat fih 27.73 mg docetaxel.
English: Each carton contains:
Maltese: Kull kartuna fiha:
English: Without primary G-CSF prophylaxis (n = 111) n (%)
Maltese: Mingħajr profilassi primarja ta' G-CSF (n = 111) n (%)
English: Gastrointestinal reactions
Maltese: Reazzjonijiet gastrointestinali
English: Docetaxel concentrate vial: polysorbate 80, anhydrous ethanol.
Maltese: Kunjett tal-konċentrat ta' Docetaxel polysorbate 80, ethanol anidru
English: Docetaxel is more than 95% bound to plasma proteins.
Maltese: Docetaxel huwa iktar minn 95% marbut mal-proteini talplażma.
English: Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal products has not been investigated formally, in vitro interactions with tightly protein-bound drugs such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Maltese: Għalkemm il-possibbiltà t'interazzjoni in vivo ta' docetaxel ma' mediċini oħra li ngħatat konkomittantement ma kinux investigati formalment, l-interazzjonijiet in-vitro b'sustanzi li huma marbuta sew mal-proteina bħal erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole, u sodium valproate, m'effetwawx ir-rabta ta' docetaxel mal-proteina; hekk ukoll dexamethasone m'effetwawx l-effetti fuq ir-rabta ta' docetaxel mal-proteina.
English: • Mitoxantrone 12 mg/m2 every 3 weeks for 10 cycles.
Maltese: • Mitoxantrone 12 mg/m
English: Neutropenic infection Neutropenic infection (Grade 3-4)
Maltese: Infezzjoni newtropenika (Grad 3-4)
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Preparation of the Docetaxel Teva Pharma premix solution (10 mg docetaxel/ml)
Maltese: .1 Preparazzjoni ta' Docetaxel Teva Pharma, soluzzjoni mħallta bil-lest (10 mg docetaxel/ml)
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 flimkien ma' trastuzumab meta mqabbel ma' 0% tal-pazjenti li ngħataw docetaxel wahdu.
English: 4.1.3 Inject the entire contents of the syringe into the corresponding Docetaxel Teva Pharma vial.
Maltese: 4.1.3 Injetta il-kontenut sħiħ tas-siringa fil-kunjett korrispondenti ta' Docetaxel Teva Pharma.
English: Teva Operations Poland Sp. z.o.o.
Maltese: Teva Operations Poland Sp. z.o.o. Sienkiewicza 25
English: Docetaxel increased response rate (33% vs. 12%, p<0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p=0.0004) and prolonged overall survival (11 months vs. 9 months, p=0.01).
Maltese: Docetaxel żied r-rata tar-rispons (33% vs 12%, p < 0.0001), ittardja l-avvanz tat-tumur (19-il ġimgħa vs 11-il ġimgħa, p = 0.0004) u tawwal iż-żmien totali tas-sopravivenza (11-il xahar vs 9 xhur, p = 0.01).
English: Frequency unknown:
Maltese: Doża rrakkomandata:
English: Preparation for the intravenous administration a) Preparation of the Docetaxel Teva Pharma premix solution (10 mg docetaxel/ml)
Maltese: Il-preparazzjoni tal-prodott għall-għoti ġol-vini a) Preparazzjoni ta'Docetaxel Teva Pharma, soluzzjoni mħallta bil-lest (10 mg docetaxel/ml)
English: A total of 1006 patients with KPS≥60 were randomized to the following treatment groups:
Maltese: Total ta' 1006 pazjenti b'KPS ≥ 60 kienu mqassma mingħajr għażla fi gruppi ta' trattament kif deskritt hawn taħt:
English: Headache (G3/4: <1%); Neuropathy peripheral
Maltese: Uġigħ ta' ras (G3/4: < 1%); Newropatija periferika
English: Overall survival (Primary end-point):
Maltese: Sopravivenza globali (L-aħħar stadju primarju tal-proċess):
English: Myelodysplastic syndrome was reported in 2 of 744 TAC patients and in 1 of 736 FAC patients.
Maltese: Is-sindrome majilodisplastik ġie rrappurtat f'2 minn 744 pazjenti fuq TAC u f'1 minn 736 pazjent fuq FAC.
English: Very rare cases of cutaneous lupus erythematous and bullous eruptions such as erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Maltese: Każijiet rari ħafna ta' lupus erythematosus tal-ġilda u nfafet kbar bħal erythema multiforme, issindrome ta' Stevens-Johnson, u toxic epidermal necrolysis, kienu ġew irrapportati b'docetaxel.
English: In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Maltese: Fl-istudju TAX316 26 pazjent (3.5%) fil-fergħa tat-TAC u 17-il pazjent (2.3%) fil-fergħa tal-FAC esperjenzaw insuffiċjenza konġestiva tal-qalb.