FrancophonIA/ELRC3.0 huggingface dataset:
English: On 8 May 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Topamax and associated names in the EU and the EEA.
Maltese: Fit-8 ta' Mejju 2008, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP sabiex tarmonizza l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Topamax u ismijiet assoċjati fl-UE u fiżŻEE.
English: For adjunctive therapy, the Committee endorsed a dose range for adults of 200 to 400 mg a day, divided into two doses.
Maltese: Għal terapija aġġuntiva, il-Kumitat awtorizza firxa ta' dożi għall-adulti ta' 200 sa 400 mg kuljum, diviżi f'żewġ dożi.
English: The main differences concerned the age of children that can be given Topamax, and the medicine's use in monotherapy and conversion to monotherapy.
Maltese: Id-differenzi prinċipali kellhom x'jaqsmu mal-età tat-tfal li jistgħu jingħataw Topamax, u mal-użu tal-mediċina f'monoterpaija u f'konverżjoni għal monoterapija.
English: The exact way in which topiramate, the active substance in Topamax, works is unknown but it is thought to act by interfering with the activity of receptors on nerve cells, which leads to a reduction in electrical transmission.
Maltese: Il-mod preċiż ta' kif jaħdem topiramate, is-sustanza attiva f'Topamax, għadu mhuwiex magħruf, iżda huwa maħsub li jaġixxi billi jinterferixxi mal-attività tar-riċettaturi fuq iċ-ċelloli tan-nervituri, li jwassal għal tnaqqis fit-trasmissjoni tal-elettriku.
English: Why was Topamax reviewed?
Maltese: Għaliex ġie rivedut Topamax?
English: The CHMP harmonised the SPC section on special warnings and included warnings about mood disturbances and depression, suicide and suicidal ideation, and metabolic acidosis (increased acid levels in the body).
Maltese: Is-CHMP armonizza s-sezzjoni tal-SPC dwar it-twissijiet speċjali u nkluda twissijiet dwar id-disturbi fil-burdata u d-depressjoni, suwiċidju u ideat ta' suwiċidju, u aċidożi metabolika (livelli ta' aċidi miżjudin fil-ġisem).
English: Topamax and associated names have been authorised in the EU via national procedures.
Maltese: Topamax u ismijiet assoċjati ġie awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: The new wording highlights the possibility of reduced effectiveness of oral contraceptives in patients taking Topamax.
Maltese: Il-formolazzjoni l-ġdida tenfasizza l-possibbiltà ta' effikaċja mnaqqsa ta' kontraċettivi orali f'pazjenti li jkunu qegħdin jieħdu Topamax.
English: Company responses provided on: 29 Aug 2008, 28 Jan 2009, 19 Mar 2009, 28 May 2009 Opinion date:
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fl-1 ta' Ottubru 2009.
English: It is used as monotherapy (on its own) or as adjunctive therapy (together with other medicines) to prevent seizures (epileptic fits).
Maltese: Tintuża bħala monoterapija (waħidha) jew bħala terapija addizzjonali (flimkien ma' mediċini oħrajn) sabiex timpedixxi puplesija (attakki epilettiċi).
English: The European Medicines Agency has completed a review of Topamax and associated names.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni ta' Topamax u ismijiet assoċjati.
English: The CHMP agreed on a harmonised wording for the indications:
Maltese: Is-CHMP qabel fuq il-formolazzjoni armonizzata għall-indikazzjonijiet:
English: The CHMP removed a restriction that was present in some Member States that Topamax monotherapy be used for only newly diagnosed epilepsy.
Maltese: Is-CHMP neħħa restrizzjoni li kienet preżenti f'xi Stati Membri li monoterapija b'Topamax tintuża biss għal epilessija li tkun għadha kif ġiet dijanjostikata.
English: 4.2 Posology and method of administration
Maltese: .2 Pożoloġija u metodu ta' kif jingħata
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Topamax and associated names in the European Union (EU) and the European Economic Area (EEA).
Maltese: Il-Kumitat talAġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li fl-Unjoni Ewropea (UE) u fiż-Żona Ekonomika Ewropea (ŻEE), jeħtieġ li l-informazzjoni ta' preskrizzjoni tiġi armonizzata għal Topamax u ismijiet assoċjati.
English: The initial dose should be of 25 mg a day for one week followed by weekly increases of 25 mg until a beneficial dose is reached.
Maltese: Id-doża inizjali għandha tkun 25 mg kuljum għal ġimgħa segwita b'żidiet ta' kull ġimgħa ta' 25 mg sakemm tintlaħaq doża benefiċjali.
English: Advice was included in section 4.6 of the SPC about the risks to the mother and the unborn baby of treatment with Topamax.
Maltese: Fis-sezzjoni 4.6 tal-SPC, ġie nkluż parir dwar ir-riskji għall-omm u għat-tarbija mhux imwielda mill-kura b'Topamax.
English: The Committee also harmonised the SPC section on the interactions of Topamax with other medicines.
Maltese: Il-Kumitat armonizza wkoll is-sezzjoni tal-SPC dwar l-interazzjonijiet ta' Topamax ma' mediċini oħrajn.
English: For prevention of migraine in adults, the Committee recommended a total daily dose of 100 mg, divided into two doses.
Maltese: Emigranja Għall-prevenzjoni tal-emigranja fl-adulti, il-Kumitat irrakkomanda doża totali ta' kuljum ta' 100 mg, diviża f'żewġ dożi.
English: Page 2/2©EMEA 2007
Maltese: Paġna 2/2©EMEA 2007
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NOBIVAC BB EPAR summary for the public
Maltese: EMEA/V/C/068 RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEA (EPAR) NOBIVAC BB Sommarju ta' l-EPAR għall-pubbliku
English: What is Nobivac Bb?
Maltese: Kif jaħdem Nobivac Bb?
English: Nobivac Bb is a vaccine that contains a live bacterium Bordetella bronchiseptica strain B-C2.
Maltese: Nobivac Bb hu vaċċin li jkun fiħ il-batterju ħaj Bordetella bronchiseptica tar-razza B-C2.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nobivac Bb to Intervet International B.V. on 10 September 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Nobivac Bb lil Intervet International B.V. fl-10 ta' Settembru 2002. Lawtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fil-25 ta' Settembru 2007.
English: Nobivac Bb contains a type of live B. bronchiseptica called strain B-C2.
Maltese: Nobivac Bb ikun fih tip ta' B. bronchiseptica ħaj magħruf bħala razza B-C2.
English: Why has Nobivac Bb been approved?
Maltese: Għaliex ġie aprovat Nobivac Bb?
English: Although the risk for people with weak immune systems becoming infected with B. bronchiseptica is extremely low, it is advised that cats which are in close contact with such people are not vaccinated with Nobivac Bb, since they can shed the bacteria intermittently for up to a year after vaccination.
Maltese: Għalkemm ir-riskju li nies b'sistemi immunitarji baxxi jinfettaw ruħom b' B. bronchiseptica huwa wieħed baxx ħafna, huwa rakkomandat li l-qtates li jkunu f'kuntatt mill-qrib ma' dawn in-nies ma jitlaqqmux b'Nobivac Bb, għax dawn jistgħu jnixxu l-batterji kull tant ħin sa sena wara t-tilqim.
English: How has Nobivac Bb been studied?
Maltese: Kif ġie studjat Nobivac Bb?
English: The effectiveness of Nobivac Bb was investigated in three main studies involving cats of various breeds.
Maltese: L-effikaċja ta' Nobivac Bb kienet investigata fi tliet studji ewlenin li fihom ħadu qtates ta' diversi razez.
English: Nobivac Bb is used to vaccinate cats aged one month or older against the disease (a flu-like illness) caused by the bacterium B. bronchiseptica.
Maltese: Nobivac Bb jintuża fit-tlaqqim ta' qtates, li jkollhom xahar jew iktar, kontra l-marda (li tixbah lill-influwenza) ikkawżata mill-batterju B. bronchiseptica.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Bb exceed the risks of its use.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċju ta' Nobivac Piro huwa ikbar mir-riskju ta' l-użu tiegħu.
English: Cats are vaccinated by giving a 0.2-ml dose into one nostril.
Maltese: Il-qtates jitlaqqmu billi jingħataw doża ta' 0.2 ml f'toqba waħda ta' l-imnieħer.
English: The main studies showed that Nobivac Bb was effective in reducing the symptoms caused by B. bronchiseptica.
Maltese: L-istudji ewlenin urew li Nobivac Bb kien effettiv fit-tnaqqis tas-sintomi kkawżati millB. bronchiseptica.
English: The cats were vaccinated with Nobivac Bb before being challenged by being exposed to wild-type B. bronchiseptica.
Maltese: Il-qtates li tlaqqmu b'Nobivac Bb qabel ma ġew esposti għal B. bronchiseptica.
English: Vaccines against B. bronchiseptica that are administered through the nose are also used in dogs.
Maltese: Il-vaċċini kontra B. bronchiseptica li jiġu amministrati mill-imnieħer jintużaw ukoll fil-klieb.
English: In case of accidental administration to people seek medical advice immediately and show the Package Leaflet or label to the doctor.
Maltese: Jekk il-persuna tinjetta lilha nfisha bi żball, għandha tikseb parir mediku immedjatament.
English: What is the risk associated with Nobivac Bb?
Maltese: X'inhu r-riskju assoċjat ma' Nobivac Bb?
English: Nobivac Bb is a vaccine.
Maltese: Il-vaċċin għandu jingħata biss minn veterinarji.
English: Nobivac Bb was the first live B. bronchiseptica vaccine licensed for use in cats.
Maltese: Nobivac Bb kien l-ewwel vaċċin b'B. bronchiseptica ħaj liċenzjat għall-użu fil-qtates.
English: Gonazon contains the active substance azagly-nafarelin.
Maltese: Gonazon fih is-sustanza attiva azagly-nafarelin.
English: Gonazon contains azagly-nafarelin, which is an analogue of a natural hormone called gonadotrophinreleasing hormone (GnRH).
Maltese: Gonazon fih azagly-nafarelin, li hu analogu ta' ormon naturali magħruf bħala gonadotrophinreleasing hormone (GnRH).
English: The recommended dose is 32 μg/kg bodyweight.
Maltese: Id-doża rrakkomandata hi 32 μg għal kull kilo toqol.
English: What is Gonazon?
Maltese: X'inhu Gonazon?
English: Why has Gonazon been approved?
Maltese: Għaliex ġie approvat Gonazon?
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn ir-riskju u l-benefiċċju jista' jinstab fil-modulu 6 ta' dan l-EPAR.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Gonazon to Intervet International BV on 22 July 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Gonazon valida fl-Unjoni Ewropea kollha lil Intervet International BV fit-22 ta' Lulju 2003.
English: Gonazon implant is rectangular in shape, off white, with dimensions of 14x3x1 mm.
Maltese: L-impjant ta' Gonazon għandu għamla rettangolari, offwajt, b'dawn il-qisien: 14x3x1 mm.
English: The implant may be administered to bitches from the age of four months (blocking reproductive function for an average of 12 months) to 6 years (blocking reproductive function for an average of 11 months).
Maltese: L-impjant jista' jiġi amministrat fil-klieb nisa mill-età ta' erba' xhur (u dan jimblokka l-funzjoni riproduttiva għal medja ta' 12-il xahar) sa sitt snin (bl-imblokk tal-funzjoni riproduttiva għal medja ta' 11-il xahar).
English: In fish, Gonazon is used to induce and synchronise ovulation (egg production) in female salmonids such as Atlantic salmon, rainbow trout, brown trout and Arctic charr for the production of eyed-eggs and fry.
Maltese: Fil-ħut, Gonazon jintuża biex jinduċi u jissinkronizza l-ovulazzjoni (il-produzzjoni tal-bajd) u fissalmodids femminili, bħas-Salamun ta' l-Atlantiku, it-trota bi lwien il-qawsalla, it-trota kannella u ċcharr Arktiku għall-produzzjoni ta' bajdiet bil-għajn u ħut żgħir.
English: In bitches, Gonazon is also indicated for the prevention of gonadal function via long term blockade of gonadotrophin synthesis.
Maltese: Fil-klieb nisa, Gonazon hu indikat fil-prevenzjoni tal-funzjoni gonadali permezz ta' imblokk fit-tul tas-sintesi tal-gonadotrophin.
English: Gonazon implants are effective in prevention of gonadal function via long term blockade of gonadotrophin synthesis.
Maltese: L-impjanti ta' Gonazon huma effettivi fil-prevenzjoni tal-funzjoni gonadali permezz ta' l-imblukkar tas-sinteżi tal-gonadotrophin.
English: How has Gonazon been studied?
Maltese: Kif ġie studjat Gonazon?
English: In fish, Gonazon has been studied in three studies of rainbow trout, two studies of Altlantic salmon, and one study of Arctic charr.
Maltese: Fil-ħut, Gonazon ġie studjat fi tliet studji tat-trota bi lwien il-qawsalla, żewġ studji tas-salamun ta' lAtlantiku, u studju wieħed taċ-charr Arktiku.
English: Following anaesthesia, the fish are injected intraperitoneally (into the area that contains the abdominal organs) along the central line, 1/2 to 1 fin length in front of the pelvic fin base.
Maltese: Wara l-anestesija, il-ħut jiġi injettat fil-peritonew (fil-wisgħa li jkun fiha l-organi addominali) ma' tul linja ċentrali, bejn nofs tul u tul 'il quddiem mill-bażi tal-garġi pelviku.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Gonazon are greater than any risks for the induction and synchronisation of ovulation for the production of eyed-eggs and fry.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal użu Veterinarju (CVMP) qabel li l-benefiċċji ta' Gonazon u s-sinkronizzazzjoni ta' l-ovulazzjoni għall-produzzjoni ta' bajd bil-għajn u ħut żgħir huma ikbar mirriskji tiegħu.
English: Other information about Gonazon:
Maltese: Tagħrif ieħor dwar Gonazon:
English: Data on the return to oestrus, ovulatory oestrus and subsequent fertility once treatment has ended (i.e. once the implant had been removed) were limited, especially for repeated treatment.
Maltese: It-tagħrif dwar ir-ritorn għan-normal ta' l-utru, ta' l-utru ovulatorju u tal-fertilità sussegwenti ladarba t-trattament ikun twaqqaf (jiġifieri ladarba jkun tneħħa l-impjant) kienet limitata, speċjalment għal trattament ripetut.
English: What is the risk associated with Gonazon?
Maltese: X'inhu r-riskju assoċjat ma' Gonazon?
English: In most cases, an effect was induced within 6-11 days of treatment, and ovulation was generally advanced by 2-3 weeks.
Maltese: F'ħafna mill-każijiet, l-effett kien indott fi żmien 6 u 11-il jum mill-bidu tat-trattament, u l-ovulazzjoni ġeneralment kienet avvanzata b'bejn ġimagħtejn u tliet ġimgħat.
English: In bitches, it has been demonstrated that the insertion of a Gonazon implant will prevent heat and ovulation in adult bitches aged up to 7 years during the one or two years of treatment.
Maltese: It-trattament instab effettiv fil-prevenzjoni tas-saħna u lovulazzjoni f'kelbiet nisa adulti li ma kellhomx iktar minn seba' snin matul is-sena jew sentejn ta' trattament.
English: Docetaxel (N-Debenzoyl-N-tert-butoxycarbonyl-10-deacetyl taxol) is a semi-synthetic taxane with cytotoxic anti-neoplastic activity.
Maltese: Docetaxel (N-Debenzoyl-N-tert-butoxycarbonyl-10-deacetyl taxol) huwa taxane semi-sintetiku b'attività anti-neoplastika ċitotossika.
English: The reference product is Taxotere, concentrate and solvent for solution for infusion (20 mg and 80 mg), by Sanofi-Aventis France.
Maltese: Il-prodott ta' referenza huwa Taxotere, konċentrat u solvent għal soluzzjoni għal infużjoni (20 mg u 80 mg), minn Sanofi-Aventis Franza.
English: Since the pharmaceutical form of the Docetaxel Teva Generics (powder for solution for infusion) differs from the reference product (concentrate for solution for infusion) a hybrid application marketing authorisation application (MAA) for Docetaxel Teva Generics 20 mg / 80 mg, Powder and Solvent for Solution for Infusion, 20 mg and 80 mg was submitted, in accordance with Directive 2001/83/EC, article 10(3).
Maltese: Minħabba li l-forma farmaċewtika ta' Docetaxel Teva Generics (trab għal soluzzjoni għal infużjoni) hija differenti mill-prodott ta' referenza (konċentrat għal soluzzjoni għal infużjoni), ġiet ippreżentata applikazzjoni ibrida għal awtorizzazzjoni għattqegħid fis-suq (MAA) għal Docetaxel Teva Generics 20 mg / 80 mg, Trab u Solvent għal Soluzzjoni għal Infużjoni, 20 mg u 80 mg, skont id-Direttiva 2001/83/KE, Artikolu 10(3).
English: The reference formulation contains polysorbate 80 as an excipient, while the generic formulation contains povidone K12, hydroxypropylbetadex (HP-b-CD) and glucose monohydrate as excipients.
Maltese: Il-formulazzjoni ta' referenza fiha polysorbate 80 bħala sustanza mhux attiva, filwaqt li l-formulazzjoni ġenerika fiha povidone K12, hydroxypropylbetadex (HP-b-CD) u monoidrat tal-glukosju bħala sustanzi mhux attivi.
English: This reference product was approved through the centralised procedure and has been marketed in Europe since November 1995.
Maltese: Dan il-prodott ta' referenza kien approvat permezz ta' proċedura ċentralizzata u ilu jitqiegħed fis-suq fl-Ewropa sa minn Novembru 1995.
English: However taking into account the literature data presented by the applicant, it was noted by some members of the CHMP that according to the data by Wang et al (2010), the CMC of polysorbate 80 in human plasma protein concentration was not substantially greater than the clinically relevant range of post-infusion levels of polysorbate 80 (from Taxotere) reported by Webster et al (1997).
Maltese: Madankollu meta tqieset id-dejta mid-dokumentazzjoni ppreżentata mill-applikant, xi membri tasCHMP innotaw li skont id-dejta minn Wang et al (2010), is-CMC ta' polysorbate 80 fil-konċentrat tal-proteini tal-plażma tal-bniedem ma kienx sostanzjalment akbar mill-firxa klinikament rilevanti ta' livelli wara l-infużjoni ta' polysorbate 80 (minn Taxotere) irrapportat minn Webster et al (1997).
English: • The in vitro protein binding data point at comparable docetaxel exposure obtained from Taxotere and Docetaxel Teva Generics;
Maltese: • Id-dejta dwar ir-rabta mal-proteina in vitro tindika espożizzjoni komparabbli ta' docetaxel miksuba minn Taxotere u Docetaxel Teva Generics;
English: The function of the excipients polysorbate 80 in Taxotere, and of HP-b-CD and povidone K12 in Docetaxel Teva Generics, is to solubilise docetaxel to produce a solution for infusion that is stable on storage, and to protect against the active compound sticking to container walls or precipitating during storing, during the dilution into an infusate, and during the initial infusion procedure.
Maltese: Il-funzjoni tas-sustanzi mhux attivi polysorbate 80 f'Taxotere, u ta' HP-b-CD u ta' povidone K12 f'Docetaxel Teva Generics, hija li jħollu docetaxel u jipproduċu soluzzjoni għal infużjoni li hija stabbli waqt il-ħażna, u li jipproteġu lill-kompost attiv milli jeħel mal-ħitan tal-kontenitur jew milli jippreċipita waqt il-ħażna, waqt id-dilwizzjoni f'infusat, u waqt il-proċedura inizjali ta' infużjoni.
English: Supportive PD and PK data were obtained from animal models, and indicate comparability with respect to docetaxel pharmacokinetics (rat, monkey), pharmacodynamics and toxicological parameters.
Maltese: Dejta PD u PK ta' appoġġ inkisbet minn mudelli ta' annimali, u tindika komparabilità firrigward tal-farmakokinetika ta' docetaxel (far, xadina), farmakodinamiċi u parametri tossikoloġiċi.
English: Further evidence was also presented that the clinical data on free fraction during infusion do not support any transient effects on free fraction (Acharya et al., 2004).
Maltese: Ġiet ippreżentata wkoll aktar evidenza li d-dejta klinika dwar frazzjoni ħielsa waqt l-infużjoni ma tappoġġax kwalunkwe effett li jgħaddi fuq il-frazzjoni ħielsa (Acharya et al., 2004).
English: Concerns were expressed that the formulations (cyclodextrin complexes vs. traditional micelles) are different, and that this generic docetaxel formulation had never been given to man.
Maltese: Kien hemm tħassib li l-formulazzjonijiet (kumplessi ta' cyclodextrin vs. miċelli tradizzjonali) huma differenti, u li din il-formulazzjoni ġenerika ta' docetaxel qatt ma kienet ingħatat lill-bnedmin.
English: Pharmaceutical quality of Docetaxel Teva Generics is comparable to that of Taxotere.
Maltese: Il-kwalità farmaċewtika ta' Docetaxel Teva Generics hija komparabbli ma' dik ta' Taxotere.
English: The micelle forming polysorbate used in the originator is exchanged for a cyclodextrin derivative in Docetaxel Teva Generics, which has a different form of interaction with the drug substance.
Maltese: Il-polysorbate li jifforma l-miċelli wżat fl-oriġinatur huwa skambjat ma' derivattiva ta' cyclodextrin f'Docetaxel Teva Generics, li għandha forma ta' azzjoni differenti mas-sustanza tal-mediċina.
English: Moreover, polysorbate 80 micelles are very unstable and will disappear rapidly due to hydrolyses and metabolism by plasma carboxyesterases.
Maltese: Barra minn hekk, miċelli ta' polysorbate 80 huma instabbli ħafna u jisparixxu malajr minħabba l-idroliżi u l-metaboliżmu minn carboxyesterases tal-plażma.
English: Therefore the risk-benefit balance for Docetaxel Teva Generics is positive.
Maltese: Għalhekk il-bilanċ ta' riskju-benefiċċju għal Docetaxel Teva Generics huwa wieħed pożittiv.
English: Overall summary of the scientific evaluation of Docetaxel Teva Generics (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Docetaxel Teva Generics (ara Anness I)
English: Since the formulation of Docetaxel Teva Generics is different from the originator, different release characteristics and in vivo pharmacokinetic profile cannot be ruled out.
Maltese: Ladarba lformulazzjoni ta' Docetaxel Teva Generics hija differenti minn dik tal-oriġinatur, ma jistgħux jiġu esklużi l-karatteristiċi differenti ta' rilaxx u l-profil farmakokinetiku in vivo.
English: Molecular modelling data describing the relative weak affinity for HP-b-CD, and high binding affinity for plasma proteins, indicate that plasma protein binding will be the driving force for distribution of docetaxel in the bloodstream, with only minor - if at all- effect of HP-b-CD.
Maltese: Id-dejta dwar l-immudellar molekulari li tiddeskrivi l-affinità relattiva dgħajfa għal HP-b-CD, u l-affinità għal rabta għolja mal-proteini tal-plażma, tindika li r-rabta mal-proteini talplażma se tkun il-forza għad-distribuzzjoni ta' docetaxel fid-demm, b'effett minuri bissjekk affattu - ta' HP-b-CD.
English: • With regard to safety related to the excipients, it was considered that the different excipients povidone K-12 and HP-b-CD are used in other medicinal products for intravenous use, and thus have been previously applied in humans.
Maltese: • Fir-rigward tas-sigurtà relatata mas-sustanzi mhux attivi, tqies li s-sustanzi mhux attivi differenti povidone K-12 u HP-b-CD jintużaw fi prodotti mediċinali oħra għall-użu ġol-vina, u għalhekk ġew applikati qabel fil-bnedmin.
English: In this respect it was the RMS's view that, the fact that a different methodology was applied to avoid docetaxel precipitation in the infusion bag (i.e., using HP-b-CD aggregates and povidone K-12 in case of Docetaxel Teva Generics instead of polysorbate micelles in case of Taxotere), does not impair this conclusion of comparable efficacy, since this conclusion is based on the final exposure of the identical active substance -docetaxel, in both formulations.
Maltese: F'dan ir-rigward kienet il-fehma tal-RMS li, l-fatt li kienet applikata metodoloġija differenti biex tiġi evitata l-preċipitazzjoni ta' docetaxel fil-borża talinfużjoni (jiġifieri, l-użu ta' aggregati HP-b-CD u povidone K-12 fil-każ ta' Docetaxel Teva Generics minflok miċelli ta' polysorbate fil-każ ta' Taxotere), ma jfixkilx lil din il-konklużjoni ta' effikaċja komparabbli, minħabba li din il-konklużjoni hija bbażata fuq l-espożizzjoni finali tas-sustanza attiva identika -docetaxel, fiż-żewġ formulazzjonijiet.
English: The Applicant provided compelling arguments that the CMC in plasma is much higher than the often reported CMC in water of 0.012 mM.
Maltese: L-Applikant ipprovda argumenti konvinċenti li s-CMC filplażma huwa ħafna ogħla mis-CMC ġeneralment irrapportat fl-ilma ta' 0.
English: The excipients povidone K-12 and HP-b-CD that are used in Docetaxel Teva Generics, but are not used in Taxotere, are known from other medicinal products, and no safety issues are expected.
Maltese: Is-sustanzi mhux attivi povidone K-12 u HP-b-CD li huma wżati f'Docetaxel Teva Generics, iżda mhumiex użati f'Taxotere, huma magħrufa minn prodotti mediċinali oħra, u ma hija mistennija l-ebda kwistjoni tas-sigurtà.