FrancophonIA/ELRC3.0 huggingface dataset:
English: What Xyrem looks like and contents of the pack Xyrem is supplied in a 240 mL amber plastic bottle containing 180 mL of oral solution and closed with a child-resistant cap.
Maltese: Il-flixkun tal-plastik ta' kulur ambra fiħ 180 mL ta' soluzzjoni orali.
English: The safety and efficacy of sodium oxybate in children and adolescents aged 0-18 years has not been established.
Maltese: Ma ġietx stabbilita is-sigurtà u l-effikaċja ta' sodium oxybate f'tfal u addoloxxenti ta' bejn 0-18 -il sena'.
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate (single dose of 2.25 g) and the antidepressants protriptyline hydrochloride (single dose of 10 mg) and duloxetine (60 mg at steady state).
Maltese: Studji fuq l-interazzjoni bejn il-mediċini b'sodium oxybate f'adulti f'saħħithom (doża singola ta' 2.25 g) u l-mediċina ta' kontra d-depressjoni protriptyline hydrochloride; doża singola ta' 10 mg) u duloxetine (60 mg fi stat li ma jitbiddlilx) ma wrew ebda interazzjoni farmakokinetiċi.
English: General disorders and administration site conditions Common: asthenia, fatigue, feeling drunk, oedema peripheral
Maltese: Komuni: astenja, għajja, sensazzjoni ta' sakra, edima periferali
English: The recommended starting dose is 4.5 g/day sodium oxybate divided into two equal doses of 2.25 g/dose.
Maltese: Id-doża rikkmandata tal-bidu hija ta' 4.5 g ta' sodium oxybate kuljum maqsuma f' żewġt dożi ugwali ta' 2.25 g/doża.
English: Ю СИ БИ България ЕООД Teл.
Maltese: - Din il-mediċina ġiet mogħtija lilek biss.
English: Seizures have been observed in patients treated with sodium oxybate.
Maltese: Kienu osservati aċċessjonijiet f' pazjenti fuq sodium oxybate.
English: Dose Group
Maltese: Grupp tatTrattament
English: Change from Baseline Compared to Placebo (p-value)
Maltese: Bidla mill-Linja Bażi mqabbla mall-Plaċebo (p-valur)
English: The combined use of alcohol with sodium oxybate may result in potentiation of the central nervous system-depressant effects of sodium oxybate.
Maltese: It-teħid ta' flumazenil mhux mistenni li jneħħi l-effetti fuq is-sistema nervuża ċentrali ta' sodium oxybate.
English: The dose should be titrated to effect based on efficacy and tolerability (see section 4.4) up to a maximum of 9 g/day divided into two equal doses of 4.5 g/dose by adjusting up or down in dose increments of 1.5 g/day (i.e. 0.75 g/dose).
Maltese: Għandha issir it-titrazzjoni tad-doża sakemm jintlaħqu l-effikaċja u t-tolerabilta` mixtieqa (ara sezzjoni 4.4), billi titnaqqas jew tiżdied id-doża b' 1.5 g kuljum (i.e. 0.75 g/doża) sa mhux iżjed mid-doża massima ta' 9 g/ ġurnata maqsuma f'żewġt dozi ndaqs ta' 4.5 g/doża.
English: If you take two 2.25 g doses of sodium oxybate each night you will take 0.82 g of sodium, or if you take two 4.5 g doses of sodium oxybate each night you will take in 1.6 g sodium.
Maltese: sodium, jew jekk tieħu żewġ dożi ta' 4.5 g ta' sodium oxybate kull lejl qiegħed tieħu 1.6 g ta' sodium.
English: To date no other relevant epidemiological data are available.
Maltese: S'issa m'hemmx aktar tagħrif epidemjoloġiku relevanti disponibbli.
English: Pharmacokinetics is nonlinear with the area under the plasma concentration curve (AUC) versus time curve increasing 3.8-fold as dose is doubled from 4.5 g to 9 g. The pharmacokinetics is not altered with repeat dosing.
Maltese: Il-farmakokinetika mhix linejari, b'erja taħt il-kurva talkonċentrazzjoni tal-plażma (AUC) versus il-kurva tal-ħin li tiżdied 3.8 l-darba waqt li tirdopplja ddoża minn 4.5 g to 9 g.
English: Race The effect of race on metabolism of sodium oxybate has not been evaluated.
Maltese: Razza L'effett ta' razza fuq il-metaboliżmu ta' sodium oxybate ma ġiex stimat.
English: When higher doses up to 9 g/day of sodium oxybate are combined with higher doses of opioids (within the recommended dose range) pharmacodynamic interactions associated with symptoms of CNS depression and/or respiratory depression cannot be excluded (see sections 4.3).
Maltese: Meta dożi ogħla sa 9 g/d ta' sodium oxybate jittieħdu flimkien ma' dożi ogħla ta'mediċini bħal oppju (fil-medda tad-dożi rrikkmandati) interazzjoni farmakodinamiċi assoċjati ma' sintomi ta' depressjoni tas-CNS u/jew depressjoni respiratorja ma jistgħux jiġu esklużi (ara sezzjoni 4.3).
English: Psychosis (a mental disorder that may involve hallucinations, incoherent speech, or disorganized and agitated behaviour), paranoia, abnormal thinking, hallucination, agitation, suicide attempt, difficulty in falling asleep, restless legs, forgetfulness, myoclonus (involuntary contractions of muscles), involuntary passage of faeces, hypersensitivity
Maltese: Psikożi (marda mentali li jista' jinvolvi alluċinazzjonijiet, diskors li ma jinftehimx, jew imġieba diżorganizzata u aġitata), paranojja, ħsieb abnormali, alluċinazzjonijiet, aġitazzjoni, attentat ta' suwiċidju, diffikulta' biex wieħed jorqod, restless legs, nisi, myoclonus (kontrazzjoni involontarja talmuskoli), inkontinenza tal-ħmieġ, ipersensittivita`
English: Bradycardia has been responsive to atropine intravenous administration.
Maltese: Il-bradikardja tirrispondi għal atropine meta jingħata mill-vina.
English: Sodium oxybate is rapidly and almost completely absorbed after oral administration; absorption is delayed and decreased by a high fat meal.
Maltese: Sodium oxybate huuwa assorbit rapidament u kważi kompletament wara li jittieħed mill-ħalq; lassorbiment idum iżjed u jittnaqqas ma' ikla għolja fix-xaħam.
English: Treatmentrelated clinical signs were mainly related to sedation, reduced food consumption and secondary changes in body weight, body weight gain and organ weights.
Maltese: Sinjali kliniċi li kienu marbuta mat-trattament kienu relatati ma' sedazzjoni, konsum imnaqqas ta' l-ikel u tibil sekondarju fil-piz, żieda fil-piz tal-ġisem u tal-organi.
English: ANNEX I
Maltese: 4 ġimgħat
English: Sodium oxybate is a central nervous system depressant which reduces excessive daytime sleepiness and cataplexy in patients with narcolepsy and modifies sleep architecture reducing fragmented nighttime sleep.
Maltese: Sodium oxybate huwa depressant tas-sistema nervuża ċentrali li jnaqqas nagħas eċċessiv ta' bi nhar u u kataplessija f'pazjenti b'narkolessija u jbiddel l-istruttura ta' l-irqad billi jnaqqas l-irqad mkisser waqt il-lejl.
English: Then add about 60 ml of water to each dosing cup (60 mL is about 4 tablespoons).
Maltese: Imbagħad żid madwar 60 ml ta' ilma f' kull tazza ta' dożaġġ (60 mL huwa madwar 4 imgħaref)
English: Skin and subcutaneous tissue disorders Common: hyperhidrosis, rash Not known: urticaria, angioedema, seborrhoea
Maltese: Komuni: paraliżi ta' l-irqad, nagħas, rogħda, mard tal-bilanċ, disturbi fl-attenzjoni, ipo-estesija, paraestesija, sedazzjoni, dysġewsja
English: Trial 1 enrolled 246 patients with narcolepsy and incorporated a 1 week up-titration period.
Maltese: F' Prova 1, li inkudiet ġimgħa fejn hemm żiediet fid-doża, ħadu sehem 246 pazjent b'narkolessija.
English: Median Change from Baseline
Maltese: Bidla Medja millLinja
English: Apnoea and respiratory depression have been observed in a fasting healthy subject after a single intake of 4.5 g (twice the recommended starting dose).
Maltese: Apnea u depressjoni respiratorja kienu osservati f'persuni sajma f'saħħithom wara li ħadu 4.5 g f'daqqa (d-doppju tad-doża rikkmandata tal-bidu).
English: Patients should be routinely monitored and in the case of suspected abuse, treatment with sodium oxybate should be discontinued.
Maltese: Fi provi kliniċi, ġiet rappurtata sonnambulanza f'pazjenti trattati b'sodium oxybate.
English: Co-administration of sodium oxybate and diclofenac in healthy volunteers reduced the attention deficit caused by the administration of Xyrem alone as measured by psychometric tests.
Maltese: It-teħid flimkien ta' sodium oxybate u diclofenac f'voluntiera b'saħħithom, naqsu ddefiċit fl-attenzjoni ikkawzat b' Xyrem biss kif mkejla fit-testijiet psikometriċi.
English: Information about signs and symptoms associated with overdose with sodium oxybate is limited.
Maltese: L-informazzjoni dwar is-sinjali u s-sintomi marbuta ma' doża eċċessiva b'sodium oxybate hija limitata.
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jistgħu jafftewaw sa 1 minn 10 persuni):
English: A recommendation to reduce sodium intake should be carefully considered in the management of patients with heart failure, hypertension or compromised renal function (see sections 4.2 and 4.9).
Maltese: F'pazjenti b'insuffiċjenza tal-qalb, pressjoni għolja jew funzjoni renali kompromett, għandha tiġi kunsidrata b'attenzjoni rrikkmandazzjoni li jitnaqqas is-sodium (ara sezzjonijiet 4.2 u 4.9).
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: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The safety and efficacy of sodium oxybate for the treatment of narcolepsy symptoms was established in four multicentre, randomised, double-blind, placebo-controlled, parallel-group trials in patients with narcolepsy with cataplexy except for one trial where cataplexy was not required for enrolment.
Maltese: Is-sigurta` u l-effikaċja ta' sodium oxybate ghat-trattament tas-sintomi ta' narkolessija kienu stabbiliti f' erba' provi multi-ċentrali, randomizzati, double-blind, ikkontrollati mil plaċebo, fi grupp paralleli b'pazjenti b'narkolessija b'kataplessija ħlief ghal prova waħda fejn ma kienx hemm bżonn kataplessija sabiex tintagħżel.
English: Symptoms of Xyrem overdose may include agitation, confusion, impaired movement, impaired breathing, blurred vision, profuse sweating, headache, vomiting, decreased consciousness leading to coma and seizures excessive thirst, muscle cramps and weakness.
Maltese: Is-sintomi meta jittieħed aktar Xyrem milli suppost jistgħu jinkudu aġitazzjoni, konfużjoni, moviment indebolit, nifs indebolit, viżjoni mċajpra, ħafna għaraq, uġigħ ta' ras, rimettar, koxjenza mnaqqsa li tista' twassal għal koma u attakk ta' puplesija, għatx eċċessiv, bugħawwieġ fil-muskoli u dgħufija.
English: Xyrem is used to treat narcolepsy with cataplexy in adults.
Maltese: Xyrem jintuża fit-trattament ta' narkolessija b'katalessija fl' adulti.
English: Talk to your doctor or pharmacist before taking Xyrem: - if you have breathing or lung problems (and especially if you are obese), because Xyrem has the potential to cause difficulty in breathing; - if you have or have previously had depressive illness; - if you have heart failure, hypertension (high blood pressure), liver or kidney problems as your dose may need to be adjusted; - if you have previously abused drugs; - if you suffer from epilepsy as the use of Xyrem is not recommended in this condition; - if you have porphyria (an uncommon metabolic disorder).
Maltese: Xyrem għandu l-potenzjal li jikkawża diffikulta` biex tieħu n-nifs; - jekk għandek jew kellek qabel xi mard depressiv; - jekk għandek insuffiċjenza tal-qalb, ipertensjoni (pressjoni għolja), problemi fil-fwied jew fil kliewi għaliex id-doża tiegħek jista' jkun li trid tiġi aġġustata; - jekk qatt qabel abbużajt bid-droġa - jekk tbati minn epilessija l-użu ta' Xyrem mhux rikkmandat f'din il-kondizzjoni - jekk għandek porfirja (mard metabolika mhux komuni)
English: Patients taking sodium oxybate will have an additional daily intake of sodium that ranges from 0.82 g (for a 4.5 g/day Xyrem dose) to 1.6 g (for a 9 g/day Xyrem dose).
Maltese: Pazjenti fuq sodium oxybate jkunu qegħdin jieħdu bejn 0.75g (għal doża ta' 4.5g kuljum Xyrem) sa 1.6g (għal doża ta' 9g kuljum Xyrem) ta' sodium iżjed kuljum.
English: Abuse potential and dependence
Maltese: Il-potenzjal ta' abbuż u d-dipendenza
English: If you stop taking Xyrem
Maltese: Struzzjonijiet ta' kif tiddilwa Xyrem
English: Not known (cannot be estimated from the available data):
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-dejta disponibli):
English: Table 6 Summary of outcome in Trial 4
Maltese: Skeda 6 Ġabra fil-Qosor tar-Riżultati f'Prova 4
English: Sodium oxybate and/or its metabolites are excreted into breast milk.
Maltese: Sodium Oxybate u/jew il-metaboliti tiegħu jispiċċaw fil-ħalib tas-sider.
English: No effect on the pharmacokinetics of valproate was observed.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni orali.
English: How to store Xyrem
Maltese: STRUZZJONIJIET DWAR L-UŻU
English: Injury, poisoning and procedural complications Common: fall
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura:
English: There have been very few women who have taken Xyrem sometime during their pregnancy and a few of them had spontaneous abortions.
Maltese: Kien hemm ftit ħafna nisa li ħadu Xyrem f'xi żmien waqt it-tqala u xi ftit minnhom kellhom abort spontanju.
English: Single doses greater than 4.5 g have not been studied.
Maltese: Dożi singoli ta' iżjed minn 4.5g ma kienux studjati.
English: Therefore, patients should be warned against the use of topiramate in conjunction with sodium oxybate (section 4.5).
Maltese: Għalhekk, il-pazjenti għandhom jitwissew kontra l'użu ta' topiramate flimkien ma' sodium oxybate (section 4.5).
English: There have been clinical observation(s) of coma and increased plasma GHB concentration after co-administration of sodium oxybate with topiramate.
Maltese: Pazjenti jistgħu jsiru konfużi meta jkunu fuq trattament b'sodium oxybate.
English: 4 weeks
Maltese: 40 ġurnata
English: Do not take Xyrem - if you are allergic to sodium oxybate or any of the other ingredients of this medicine (listed in section 6); - if you have succinic semialdehyde dehydrogenase deficiency (a rare metabolic disorder); - if you suffer from major depression; - if you are being treated with opioid or barbiturate medicines.
Maltese: Tieħux Xyrem - jekk inti allerġiku/a għal sodium oxybate jew għal xi sustanza oħra f'din il-mediċina (elenkati f'sezzjoni 6). - jekk tbati minn defiċjenza ta' succinic semialdehyde dehydrogenase ( marda metabolika rari) - jekk tbati minn depressjoni maġġuri - jekk qiegħed fuq trattament b' opoids jew mediċini barbiturati.
English: Cataplexy Attacks
Maltese: Indeboliment tal-kliewi
English: Neuropsychiatric events
Maltese: TWISSIJA(IET) SPEĊJALI
English: The primary measures of efficacy were changes in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS), and the change in the overall severity of the patient's narcolepsy symptoms as assessed by the investigator using the Clinical Global Impressions of Change (CGI-c) measure.
Maltese: Effetti li jiggravaw mal-waqfien u sindromu ta' waqfien mill-mediċina L-effetti ta' meta jitwaqqaf sodium oxybate ma ġewx evalwati sistematikament f'provi kliniċi kontrollati.
English: A drug interaction study in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate (single dose of 4.5 g) and modafinil (single dose of 200 mg).
Maltese: Studju fuq l-interazzjoni bejn il-mediċini b'sodium oxybate f'adulti f'saħħithom (doża singola ta' 4.5 g) u modafinil (doża singola ta' 200 mg) u zolpidem tartrate ( ipnotiku [mhux benzodiazepine]; doża singola ta' 5mg) ma wrew ebda interazzjoni farmakokinetiċi.
English: Because of the higher risk of sleep apnoea, patients with a BMI ≥40 kg/m should be monitored closely when taking sodium oxybate.
Maltese: Minħabba r-riskju akbar ta'waqfien tan-nifs għal ftit ħin waqt l-irqad, pazjenti b' BMI ≥40 kg/m2 għandhom jiġu segwiti mill-qrib waqt li jkunu qed jieħdu sodium oxybate.
English: Although the clinical trial experience with sodium oxybate in narcolepsy/cataplexy patients at therapeutic doses does not show clear evidence of a withdrawal syndrome, in rare cases, adverse reactions such as insomnia, headache, anxiety, dizziness, sleep disorder, somnolence, hallucination, and psychotic disorders were observed after GHB discontinuation.
Maltese: Għalkemm l-esperjenza minn provi kliniċi b' sodium oxybate f'dożi terapewtiċi f'pazjenti b' narkolessija/ kataplessija ma jurux evidenza ċara ta' sindromu ta' waqfien mill-mediċina, f'każi rari, effetti mhux mixtieqa bħal insomnja, uġigħ ta' ras, anzjeta`, sturdament, mard ta' l-irqad, nagħas, alluċinazzjoni, u mard psikotiku kienu osservati wara il-waqfien ta' GHB.
English: Changes in sleep patterns have been observed in breastfed infants from exposed mothers, which may be consistent with the effects of sodium oxybate on the nervous system.
Maltese: Bidliet fl-irqad ġew osservati fi tfal żgħar li ġew mreddgħin minn ommijiet esposti, li tista' tkun konsistenti mal-effetti ta sodium oxybate fis-sistema nervuża.
English: Each mL of solution contains 500 mg sodium oxybate
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull mL ta' soluzzjoni fih 500 mg sodium oxybate
English: Hepatic impairment
Maltese: Immaniġġar
English: ANNEX II
Maltese: Skeda 5
English: The average peak plasma concentrations (1st and 2nd peak) following administration of a 9 g daily dose divided into two equivalent doses given four hours apart were 78 and 142 µg/mL, respectively.
Maltese: Il-medja ta' l-ogħla konċentrazzjonijiet tal-plażma ( l-ewwel u t-tieni l-ogħla) wara amministrazzjoni ta' doża kuljum ta' 9g maqsuma f'żewġt dożi ekwivalenti li jingħataw erbgħa siegħat l-bogħod minn xulxin kienu ta' 78 u 142 g/mL, rispettivament.
English: Purified water
Maltese: Ilma purifikat
English: Do not use this medicine after the expiry date stated on the bottle after (EXP).
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-flixkun wara (EXP).
English: The pharmacodynamic interaction with zolpidem has not been assessed.
Maltese: L-interazzjoni farmakodinamiċi ma' zolpidem ma ġewx imkejla.
English: Musculoskeletal and connective tissue disorders Common: arthralgia, muscle, spasms, back pain
Maltese: Komuni: artralġia, spażmi fil-muskoli, uġigħ fid-dahar
English: All patients with impaired renal function should consider a recommendation to reduce sodium intake (see section 4.4).
Maltese: Il- pazjenti kollha b' indeboliment tal-kliewi għandhom jikkunsidraw ir-rikkomandazzjoni li jieħdu inqas sodium (ara sezzjoni 4.4).
English: Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (Ara Anness I : Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: For storage conditions after first opening of the medicinal product, see section 6.3 For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-ewwel ftuħ tal-prodott mediċinali, ara sezzjoni 6.3. Għall-kundizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: Further information on Pemetrexed Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Pemetrexed Krka tinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Pemetrexed Krka contains the active substance pemetrexed.
Maltese: Pemetrexed Krka fih is-sustanza attiva pemetrexed.
English: How is Permetrexed Krka used?
Maltese: Kif jintuża Permetrexed Krka?
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes involved in producing nucleotides (the building blocks of DNA and RNA, the genetic material of cells).
Maltese: Fil-ġisem, il-pemetrexed tinbidel f'forma attiva li timblokka l-attività tal-enzimi li huma involuti fil-produzzjoni ta' nukleotidi (blokki li fuqhom jinbnew id-DNA u l-RNA, il-materjal ġenetiku taċċelloli).
English: The recommended dose of Permetrexed Krka is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Maltese: Id-doża rakkomandata ta' Permetrexed Krka hija ta' 500 mg għal kull metru kwadru ta' superfiċje (ikkalkolata bit-tul u bil-piż tal-pazjent).
English: Pemetrexed Krka is a cancer medicine used to treat two types of lung cancer:
Maltese: Pemetrexed Krka huwa mediċina kontra l-kanċer li tintuża biex tikkura żewġ tipi ta' kanċers talpulmun:
English: The active substance in Pemetrexed Krka, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Maltese: Is-sustanza attiva f'Pemetrexed Krka, il-pemetrexed, hija mediċina ċitotossika (mediċina li toqtol iċċelloli li jkunu qed jiddividu ruħhom, bħaċ-ċelloli tal-kanċer) li jagħmlu parti mill-grupp tal”antimetaboliti”.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument mistoqsijiet u tweġibiet hawn.
English: As for all medicines, data on the use of Pemetrexed Krka are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Pemetrexed Krka tiġi ssorveljata kontinwament.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Alimta, and do not need to be repeated for Pemetrexed Krka.
Maltese: Studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użi awtorizzati diġà twettqu bil-mediċina ta' referenza, Alimta, u ma għandhomx għalfejn jiġu ripetuti għal Pemetrexed Krka.
English: Other information about Pemetrexed Krka
Maltese: Aktar tagħrif dwar Pemetrexed Krka
English: What are the benefits and risks of Pemetrexed Krka?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Pemetrexed Krka?
English: Pemetrexed is converted into its active form more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Maltese: Il-konverżjoni tal-pemetrexed fil-forma attiva tagħha ssir iktar malajr fiċ-ċelloli tal-kanċer milli f'ċelloli normali, u dan iwassal għal livelli ogħla talforma attiva tal-mediċina u l-azzjoni ddum iktar fiċ-ċelloli tal-kanċer.
English: Because Pemetrexed Krka 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: Peress li Pemetrexed Krka 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: There was no need for ‘bioequivalence' studies to investigate whether Pemetrexed Krka is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' “bijoekwivalenza” biex jiġi investigat jekk Pemetrexed Krka jiġix assorbit b'mod simili bħall-mediċina ta' referenza biex jipproduċi l-istess livell tas-sustanza attiva fiddemm.
English: How does Pemetrexed Krka work?
Maltese: Pemetrexed Krka?
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Krka.
Maltese: Biex jitnaqqsu l-effetti sekondarji, il-pazjenti għandhom jieħdu kortikosterojde (tip ta' mediċina li tnaqqas l-infjammazzjoni) u aċidu foliku (tip ta' vitamina), u għandhom jingħataw injezzjonijiet ta' vitamina
English: This means that Pemetrexed Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Alimta.
Maltese: Dan ifisser li Pemetrexed Krka fih l-istess sustanza attiva u jaħdem bl-istess mod bħal “mediċina ta' referenza” diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Alimta.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Pemetrexed Krka has been shown to be comparable to Alimta.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, f'konformità mar-rekwiżiti tal-UE, Pemetrexed Krka ntwera li huwa komparabbli ma' Alimta.