FrancophonIA/ELRC3.0 huggingface dataset:
English: Importantly, gastrointestinal effects and slightly elevated liver enzymes in dogs were not associated with histopathological changes of gastrointestinal and annexed tissues (pancreas, liver).
Maltese: B'mod importanti, effetti gastrointestinali u livelli kemxejn għolja ta' enzimi tal-fwied fil-klieb ma kinux assoċjati ma' bidliet istopatoloġiċi tat-tessuti gastrointestinali u tessuti annessi (frixa, fwied).
English: • The reconstituted solution must be then diluted in 250mL IV bag (either 0.9% Sodium Chloride Injection or D5W) prior to administration.
Maltese: • Is-soluzzjoni rikostitwita għandha mbagħad tiġi dilwita f'borża ta' 250 mL IV (ta' Injezzjoni ta' 0.9% Sodium Chloride jew inkella D5W) qabel ma tingħata.
English: • Muscle inflammation/pain
Maltese: • Infjammazzjoni/uġigħ fil-muskolu
English: Peak concentrations for the mild and moderate renal impairment patients were similar to that of healthy subjects, whereas peak concentrations were 2.1-fold, 5.9-fold and 6.4-fold higher for patients with severe renal impairment and ESRD on haemodialysis with and without haemodialysis after dosing, respectively.
Maltese: L-ogħla konċentrazzjonijiet għall-pazjent b'indeboliment minn ħafif sa moderat tal-kliewi kienu jixbhu lil dawk ta' individwi f'saħħihom, filwaqt li l-ogħla konċentrazzjonijiet kienu 2.1 drabi, 5.9 drabi u 6.4 drabi aktar għal pazjenti b'indeboliment sever talkliewi u ESRD fuq l-emodijalisi bl-emodijalisi jew mingħajrha wara l-għoti tad-doża, rispettivament.
English: • Reduced kidneys function
Maltese: • Funzjoni mnaqqsa tal-kliewi • Demm fl-awrina
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Maltese: min ikun qed jużah, u s-soltu ma jkunux aktar minn 24 siegħa f'temperatura ta' 2 sa 8°C, ħlief jekk irrikostituzzjoni u d-dilwizzjoni tkun saret f'kundizzjonijiet asettiċi kkontrollati u valutati.
English: Disodium edetate
Maltese: Bijotrasformazzjoni
English: Take the medicine pack with you.
Maltese: Ħu lpakkett tal-pilloli miegħek.
English: Powder for concentrate for solution for infusion (powder for concentrate).
Maltese: Trab għal konċentrat għal soluzzjoni għall-infużjoni (trab għall-konċentrat).
English: • Medical device occlusion
Maltese: • Sadda ta' apparat mediku
English: - Keep this leaflet.
Maltese: Menarini Kft.
English: Dyspnoea Cough Dry throat
Maltese: Jista' jkollok bżonn terġa' taqrah.
English: Blood and lymphatic system disorders
Maltese: Il-medja tal-esponiment sistemiku
English: • High blood glucose levels
Maltese: GĦAMLA KWALITATTIVA
English: Accumulation of the intravenous vehicle sulfobutylbetadex sodiumoccurs in patients with moderate to severe renal impairment; therefore serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to switch to Quofenix 450 mg tablet every 12 hours.
Maltese: Jseħħ akkumulu tas-sustanza sulfobutylbetadex sodiumoccurs li ġġorr fiha l-mediċina għal ġol-vini f'pazjenti b'indeboliment moderat jew sever tal-kliewi; għalhekk il-livelli tal-kreatinina fis-serum għandhom jiġu mmmonitorjati mill-qrib f'dawn il-pazjenti, u, jekk iseħħu żidiet, għandha titqies bidla għall-pillola Quofenix 450 mg kull 12 il-siegħa.
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: • Ħakk Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100):
English: Peak exposure (Cmax) was not statistically significantly different between renal impaired and healthy subjects.
Maltese: L-ogħla esponiment (Cmax) ma kienx differenti sinifikament b'mod statistiku bejn il-persuni b'indeboliment tal kliewi u l-individwi f'saħħithom.
English: Diarrhoea Vomiting Nausea
Maltese: Infezzjoni fl-apparat tal-awrina
English: Some adverse drug reactions (e.g. dizziness, headache, visual disorders) may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situations where the patient operates an automobile or machinery or engages in other activities requiring mental alertness and coordination.
Maltese: Xi reazzjonijiet avversi għallmediċina (eż. sturdament, uġigħ ta' ras, disturbi fil-vista) jistgħu jindebolixxu l-ħila biex il-pazjent jikkonċentra u jirreaġixxi, u għalhekk jista' jkun ta' riskju f'sitwazzjonijiet fejn il-pazjent isuq karozza jew iħaddem magna jew jagħmel attivitajiet oħra li jkunu jeħtieġu attenzjoni mentali u koordinazzjoni.
English: Hypertension Hypotension Flushing Phlebitis
Maltese: Pressjoni baxxa Fwawar Flebite
English: Hallucination, auditory Anxiety
Maltese: Alluċinazzjoni, awditorja
English: There are no data concerning an interaction of intravenous delafloxacin with multivitamins, other supplements or didanosine.
Maltese: Ma hemm l-ebda data dwar interazzjoni ta' delafloxacin mill-vini ma' multivitamini, didanosine, jew katjonji tal-metall.
English: In rats foetal effects occurred at a level of exposure exceeding about 2fold that observed in humans based on the AUC, but in rabbits, a species known to be extremely sensitive to maternal toxicity of antibacterial drugs, the effects on foetuses were recorded at levels of exposure well below that observed in humans.
Maltese: Ma ġie identifikat l-ebda periklu ta' tossiċità fil-ġeni in vitro u kien negattiv in vivo bl-ogħla doża possibbli ta' ≥ 15-il darba l-istima tal-esponiment fil-plasma tal-bniedem abbażi tal-AUC.
English: Based on in vitro data on metabolising enzymes and transporters delafloxacin possesses a low potential to alter the disposition of other medicinal products (see section 5.2).
Maltese: Abbażi ta' data in vitro dwar enzimi li jimmetabolizzaw u trasportaturi, delafloxacin għandu potenzjal baxx li jibdel id-dispożizzjoni ta' prodotti mediċinali oħra (ara sezzjoni 5.2).
English: Description of selected adverse drug reactions
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Quofenix 300 mg powder for concentrate for solution for infusion delafloxacin
Maltese: Quofenix 300 mg trab għal konċentrat għal soluzzjoni għall-infużjoni delafloxacin
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Maltese: Id data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: • Decreased appetite
Maltese: • Tnaqqis fl-aptit
English: Renal impairment Haematuria Crystal urine present
Maltese: Kif għandek tuża Quofenix
English: The highest daily intravenous dose administered in clinical studies was 1200 mg; the patients who receive this dose did not have any adverse drug reactions or notable clinical laboratory test findings during the study.
Maltese: L-ogħla doża mogħtija kuljum fl-istudji kliniċi minn ġol-vini kienet 1,200 mg; il-pazjenti li rċivew din id-doża ma kellhom l-ebda reazzjonijiet avversi għall-mediċina jew sejbiet notevoli minn testijiet kliniċi tal-laboratorju matul l-istudju.
English: No clinically meaningful changes in delafloxacin pharmacokinetics when administered delafloxacin in patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B and C) compared to matched healthy control subjects.
Maltese: Anzjani Il-farmakokinetika ta' delafloxacin ma tinbidilx b'mod sinifikanti mal-età; għalhekk, mhuwiex meħtieġ aġġustament fid-doża abbażi tal-età.
English: Following intravenous use of 300 mg delafloxacin every 12 hours, steady state concentrations are achieved after approximately 3-5 days with about 10% accumulation after multiple administrations.
Maltese: Wara l-użu ta' 300 mg delafloxacin kull 12-il siegħa minn ġol-vini, il-konċentrazzjonijiet fl-istat fiss jinkisbu wara madwar 3-5 ijiem b'akkumulu ta' madwar 10% wara għoti ta' diversi drabi.
English: It is unknown whether delafloxacin/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk delafloxacin/metaboliti jiġux eliminati fil-ħalib tas-sider tal-bniedem.
English: Oral use blister (PVC/Alu) 56 tablets
Maltese: Għall-użu orali folja (PVC/Alu)
English: Film-coated tablet
Maltese: Għamla farmaċewtika
English: Overall conclusion and benefit -risk balance
Maltese: Konklużjoni ġenerali u l-bilanċ tal-benefiċċju -riskju
English: Gastrointestinal intolerance such as nausea also occurs.
Maltese: Intolleranza gastrointestinali bħal dardir isseħħ ukoll.
English: Nicardipine is a calcium channel blocker of the dihydropyridine type which is primarily effective via peripheral vasodilatation in vascular smooth muscle rather than cardiac muscle.
Maltese: Nicardipine huwa imblokkatur tal-kanal tal-kalċju tat-tip dihydropyridine li prinċipalment huwa effettiv permezz ta' vażodilatazzjoni periferali fil-muskolu vaskulari lixx aktar milli l-muskolu tal-qalb.
English: The CHMP considered that there is a role for intravenous nicardipine in aortic dissection based on the information submitted, the evidence of widespread use, the expert statements and the absence of new safety signals in this patient population; however, in line with the available evidence, the CHMP recommended the clinical use as second line treatment, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective.
Maltese: Is-CHMP ikkunsidra li f'dissezzjoni aortika abbażi tal-informazzjoni ppreżentata, l-evidenza ta' użu wiesa', id-dikjarazzjonijiet tal-esperti u n-nuqqas ta' sinjali ġodda dwar is-sigurtà f'din il-popolazzjoni ta' pazjenti, hemm rwol għal nicardipine li jingħata ġol-vini; madankollu, f'konformità mal-evidenza disponibbli, is-CHMP irrakkomanda l-użu kliniku bħala kura tat-tieni linja, meta terapija b'imblokkatur-beta li jaġixxi fuq żmien qasir ma tkunx adegwata, jew f'kombinazzjoni ma' imblokkatur-beta meta imblokkatur-beta waħdu ma jkunx effettiv.
English: Following the submission of a marketing authorisation application under the decentralised procedure (DCP) for a generic nicardipine-containing product for intravenous (IV) use (10 mg/10ml solution for injection) and the assessment of the application dossier, the reference member state (RMS) UK considered the clinical data submitted to be insufficient to determine the efficacy, safety and overall benefit-risk of IV nicardipine in the proposed indications.
Maltese: Wara ssottomissjoni ta' applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq skont il-proċedura deċentralizzata (DCP) għal prodott ġeneriku li fih nicardipine għal użu ġol-vini (IV) (10 mg/10ml soluzzjoni għal injezzjoni) u l-valutazzjoni tad-dossier tal-applikazzjoni, l-Istat Membru ta' referenza (RMS), ir-Renju Unit, ikkunsidra li d-dejta klinika ppreżentata ma kinitx biżżejjed biex jiġu determinati l-effikaċja, is-sigurtà u l-benefiċċju-riskju ġenerali ta' nicardipine li jingħata ġol-vini flindikazzjonijiet proposti.
English: The CHMP considered all data available in its assessment, including published studies, article and guideline reviews, expert statements, user surveys, national guidelines as well as safety data from post-marketing and marketing authorisation holder databases.
Maltese: Is-CHMP ikkunsidra d-dejta kollha disponibbli fil-valutazzjoni tiegħu, inkluż studji ppubblikati, artikoli u reviżjonijiet ta' linji gwida, dikjarazzjonijiet tal-esperti, stħarriġ tal-utenti, linji gwida nazzjonali kif ukoll dejta dwar is-sigurtà wara t-tqegħid fis-suq u databases tad-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: Having reviewed the available safety data, the CHMP noted that most common adverse effects and those that most frequently result in drug discontinuance are cardiovascular and nervous system effects related to the expected vasodilator effects of the drug, in particular headache, hypotension, flushing, oedema and tachycardia.
Maltese: Wara li rreveda d-dejta disponibbli dwar is-sigurtà, isCHMP innota li l-effetti avversi l-aktar komuni u dawk li b'mod l-aktar frekwenti jwasslu għat-twaqqif tal-mediċina huma effetti kardjovaskulari u tas-sistema nervuża relatati mal-effetti vażodilatatorji mistennija tal-mediċina, b'mod partikolari uġigħ ta' ras, ipotensjoni, fwawar, edema u takikardja.
English: The CHMP concluded that data is only available to support the use of nicardipine in the post-operative hypertension indication setting.
Maltese: Is-CHMP ikkonkluda li d-dejta hija disponibbli biss biex tappoġġa l-użu ta' nicardipine fl-indikazzjoni ta' ipertensjoni wara operazzjoni.
English: Overall summary of the scientific evaluation of nicardipine-containing products for intravenous use (see Annex I)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' prodotti li fihom nicardipine għall-użu ġolvini (ara Anness I)
English: The RMS therefore decided to suspend the DCP procedure at day 210 and triggered a procedure under Article 31 of Directive 2001/83/EC, requesting the Committee for Medicinal Products for Human Use (CHMP) to review the benefit-risk of all intravenous nicardipine-containing products for intravenous use and to clarify the data supporting the licensing of these products.
Maltese: Għalhekk l-RMS iddeċieda li jissospendi l-proċedura tad-DCP fil-jum 210 u ta bidu għal proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE, fejn talab lill-Kumitat għall-Prodotti Mediċinali għall-Użu millBniedem (CHMP) jirrevedi l-benefiċċju-riskju tal-prodotti kollha li fihom nicardipine għall-użu ġol-vini u jiċċara d-dejta li tappoġġa l-liċenzjar ta' dawn il-prodotti.
English: These adverse effects are consistent with other dihydropyridine calcium channel blockers and were not considered to impact negatively on the benefit-risk balance of IV nicardipine.
Maltese: Dawn l-effetti avversi huma konsistenti ma' imblokkaturi oħra tal-kanal tal-kalċju ta' dihydropyridine u ma tqisux li għandhom impatt negattiv fuq il-bilanċ tal-benefiċċju-riskju ta' nicardipine li jingħata ġol-vini.
English: The CHMP considered that overall, sufficient evidence is available on the safety and efficacy of nicardipine containing medical products for IV use in the treatment of post-operative hypertension and treatment of acute life-threatening hypertension in specific settings, with appropriate specialist intervention and monitoring and when used by specialists.
Maltese: Is-CHMP ikkunsidra li b'mod ġenerali, hemm biżżejjed evidenza disponibbli dwar is-sigurtà u l-effikaċja ta' prodotti mediċinali li fihom nicardipine għall-użu ġol-vini għall-kura ta' ipertensjoni wara operazzjoni u għall-kura ta' ipertensjoni akuta ta' periklu għall-ħajja f'sitwazzjonijiet speċifiċi, b'interventi u monitoraġġ xierqa minn speċjalisti u meta jintużaw minn speċjalisti.
English: Intravenous nicardipine can also continue to be used in malignant arterial hypertension/hypertensive encephalopathy; however, due to the risk of intracranial pressure elevation, the CHMP recommended the addition of a warning on this risk.
Maltese: Nicardipine li jingħata ġol-vini jista' wkoll jibqa' jintuża f'ipertensjoni/ enċefalopatija ipertensiva arterjali malinna; madankollu, minħabba r-riskju ta' żieda fil-pressjoni intrakranjali, is-CHMP irrakkomanda li tiżdied twissija dwar dan ir-riskju.
English: Regarding the treatment of severe hypertension in pregnancy, the CHMP took into account the limited study data, the lack of long-term study data on morbidity and mortality and the recommendations of current guidelines.
Maltese: Fir-rigward tal-kura ta' ipertensjoni severa waqt ittqala, is-CHMP qies id-dejta limitata mill-istudji, in-nuqqas ta' dejta fit-tul minn studji dwar il-morbidità u l-mortalità u r-rakkomandazzjonijiet tal-linji gwida attwali.
English: Despite being used as a first line treatment in some member states, the CHMP considered a second-line indication to be appropriate for IV nicardipine for pre-eclampsia and agreed on an indication in severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contra-indicated.
Maltese: Minkejja li f'xi Stati Membri jintuża bħala kura tal-ewwel linja, is-CHMP ikkunsidra li għal pre-eklampsja indikazzjoni tat-tieni linja tkun adegwata għal nicardipine li jingħata ġol-vini u qabel dwar indikazzjoni fi pre-eklampsja severa, meta sustanzi oħrajn kontra l-ipertensjoni ġol-vini ma jkunux irrakkomandati jew ikunu kontraindikati.
English: • The Committee considered that in view of the identified serious limitations of the efficacy data and the overall safety profile of nicardipine, the benefits were no longer considered to outweigh the risks for some indications, which should therefore be removed;
Maltese: • Il-Kumitat ikkunsidra li fid-dawl tal-limitazzjonijiet serji identifikati tad-dejta dwar l-effikaċja u l-profil ġenerali tas-sigurtà ta' nicardipine, il-benefiċċji ma kinux għadhom jitqiesu li huma akbar mir-riskji għal xi indikazzjonijiet, u għalhekk għandhom jitneħħew;
English: Additionally, significant concerns were raised regarding the administration of IV nicardipine by bolus dose injection or direct intravenous administration due to a higher potential risk of iatrogenic hypotension, in particular in pre-eclampsia.
Maltese: Minħabba n-natura tal-popolazzjoni tal-pazjenti u s-sitwazzjonijiet possibbli ta' emerġenza fejn jintuża nicardipine ġol-vini, ma ġiet identifikata l-ebda miżura adegwata għall-minimizzazzjoni tar-riskji biex jitnaqqsu r-riskji assoċjati.
English: The Committee, as a consequence, concluded that the benefit-risk balance of intravenous nicardipinecontaining medicinal products remains positive, taking into account the restrictions, warnings and other changes to the product information.
Maltese: Bħala konsegwenza, il-Kumitat ikkonkluda li l-bilanċ tal-benefiċċju-riskju ta' prodotti mediċinali li fihom nicardipine li jingħataw ġol-vini jibqa' pożittiv, filwaqt li jitqiesu r-restrizzjonijiet, it-twissijiet u tibdil ieħor fl-informazzjoni dwar il-prodott.
English: Considering the limited efficacy data and overall safety profile, the CHMP therefore considered that the indications in hypotension should be removed from the product information.
Maltese: Meta titqies id-dejta limitata dwar l-effikaċja u l-profil ġenerali tas-sigurtà, is-CHMP għalhekk ikkunsidra li l-indikazzjonijiet f'ipotensjoni għandhom jitneħħew mill-informazzjoni dwar ilprodott.
English: In addition, significant discrepancies between the information submitted and the posology and safety information in the proposed Summary of product characteristics (SmPC) were also identified by the RMS.
Maltese: Barra minn hekk, ir-RMS identifika wkoll diskrepanzi sinifikanti bejn l-informazzjoni ppreżentata u l-pożoloġija u l-informazzjoni dwar is-sigurtà fisSommarju tal-karatteristiċi tal-prodott (SmPC) propost.
English: In view of the identified divergences in the nationally approved product information, the CHMP also considered it to be of community interest to harmonise the product information across the EU.
Maltese: Fid-dawl tad-diverġenzi identifikati flinformazzjoni dwar il-prodott approvata fuq livell nazzjonali, is-CHMP ikkunsidra li huwa wkoll flinteress tal-komunità li l-informazzjoni dwar il-prodott tiġi armonizzata fl-UE kollha.
English: In view of the available evidence and current medical knowledge on the use of intravenous nicardipine, and considering the potentially serious adverse reactions associated with the use of nicardipine, the CHMP considered that the benefit-risk balance of IV nicardipine is negative in some indications due to serious limitations of the efficacy data.
Maltese: Fid-dawl tal-evidenza disponibbli u l-għarfien mediku attwali dwar l-użu ta' nicardipine li jingħata ġolvini, u meta jitqiesu r-reazzjonijiet avversi potenzjalment serji assoċjati mal-użu ta' nicardipine, isCHMP ikkunsidra li l-bilanċ tal-benefiċċju-riskju ta' nicardipine li jingħata ġol-vini huwa wieħed negattiv f'xi indikazzjonijiet minħabba limitazzjonijiet serji tad-dejta dwar l-effikaċja.
English: EMA/1660/2016 EMEA/H/C/004071
Maltese: EMA/1660/2016 EMA/H/C/004071
English: It is a ‘hybrid medicine'.
Maltese: Dan huwa ‘mediċina ibrida'.
English: The full EPAR and risk management plan summary for Neofordex 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: Neofordex is available as 40 mg tablets.
Maltese: Neofordex jiġi bħala pilloli ta' 40 mg.
English: Other information about Neofordex
Maltese: Informazzjoni oħra dwar Neofordex
English: The reference medicine for Neofordex is Dectancyl.
Maltese: Il-mediċina ta' referenza għal Neofordex hi Dectancyl.
English: This is a summary of the European public assessment report (EPAR) for Neofordex.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Neofordex.
English: Neofordex contains the active substance dexamethasone.
Maltese: Neofordex fih is-sustanza attiva dexamethasone.
English: The usual dose is 40 mg once a day, taken preferably in the morning.
Maltese: Id-doża normali hija 40 mg darba kuljum li tittieħed preferibbilment filgħodu.
English: This means that it is similar to a reference medicine containing the same active substance, but Neofordex is available at a higher strength.
Maltese: Dan ifisser li huwa simili għal mediċina ta' referenza li fiha l-istess sustanza attiva, iżda Neofordex huwa disponibbli f'qawwa ogħla.
English: The active substance in Neofordex, dexamethasone, belongs to a group of medicines known as corticosteroids.
Maltese: Is-sustanza attiva f'Neofordex, dexamethasone, tifforma parti mill-grupp ta' mediċini magħrufin bħala kortikosterojdi.
English: The most common side effects with Neofordex (which may affect more than 1 in 10 people) include hyperglycaemia (high blood sugar levels), insomnia (difficulty sleeping), muscle pain and weakness, asthenia (weakness), tiredness, oedema (swelling) and weight increase.
Maltese: L-aktar effetti sekondarji komuni b'Neofordex (li dehru f'aktar minn pazjent 1 minn kull 10) jinkludu ipergliċemija (livelli għoljin ta' zokkor fid-demm), insomnja (diffikultà fl-irqad), uġigħ u dgħjufija filmuskoli, astenja (dgħjufija), edema (nefħa) u żieda fil-piż.
English: Neofordex is a medicine used together with cancer medicines to treat adults with multiple myeloma who have developed symptoms.
Maltese: Neofordex huwa mediċina użata flimkien ma' mediċini kontra l-kanċer biex tikkura adulti b'majeloma multipla li żviluppaw sintomi.
English: Less common but serious side effects include pneumonia (infection of the lungs) and other infections and psychiatric disorders such as depression.
Maltese: Effetti sekondarji inqas komuni iżda serji jinkludu pulmonite (infezzjoni tal-pulmun) u infezzjonijiet oħrajn u disturbi psikjatriċi bħal dipressjoni.
English: It does this by interacting with different proteins (nuclear factor kB and caspase 9) that regulate cell death.
Maltese: Jagħmel dan billi jitħallat ma' proteini differenti (fattur nukleari kB u caspase 9) li jirregolaw il-mewt taċ-ċelloli.
English: What are the risks associated with Neofordex?
Maltese: X'inhuma r-riskji assoċjati ma' Neofordex?
English: A risk management plan has been developed to ensure that Neofordex is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Neofordex jintuża bl-aktar mod sigur possibbli.
English: In addition, a bioequivalence study was carried out in 24 healthy volunteers which showed that Neofordex has comparable quality to the reference medicine, Dectancyl.
Maltese: Barra minn hekk, sar studju tal-bijoekwivalenza f'24 voluntiera b'saħħithom li wera li Neofordex għandu kwalità komparabbli għall-mediċina ta' referenza, Dectancyl.
English: Why is Neofordex approved?
Maltese: Għaliex ġie approvat Neofordex?
English: What measures are being taken to ensure the safe and effective use of Neofordex?
Maltese: Liema miżuri qed jitteħdu sabiex jiġi assigurat l-użu sigur ta' Neofordex?
English: Neofordex must not be used in patients with active viral disease (especially hepatitis, cold sores, shingles or chicken pox) or with uncontrolled psychoses (altered sense of reality).
Maltese: Neofordex m'għandux jintuża f'pazjenti b'marda virali attiva (speċjalment epatite, selħiet relatati malkesħa, ħruq ta' Sant'Antnin jew ġidri r-riħ) jew bi psikożi mhux ikkontrollata (sens mibdul tar-realtà).