FrancophonIA/ELRC3.0 huggingface dataset:
English: It is made up into a solution that is given as an intravenous infusion (drip into a vein).
Maltese: Hija magħmula f'soluzzjoni li tingħata bħala infużjoni intravenuża (drip ġol-vina).
English: What is Genasense?
Maltese: X'inhi Genasense?
English: How is Genasense expected to work?
Maltese: Kif inhi mistennija li taħdem Genasense?
English: Genasense was to be used in combination with dacarbazine (another anticancer medicine).
Maltese: Genasense kellha tintuża flimkien ma' dacarbazine (mediċina oħra kontra l-kanċer).
English: Genasense is a medicine containing the active substance oblimersen.
Maltese: Genasense hija mediċina li fiha s-sustanza attiva oblimersen.
English: By blocking the production of Bcl-2, Genasense was expected to make the cancer cells more sensitive to factors that cause cell death, including anticancer medicines such as dacarbazine.
Maltese: Genasense, billi timblokka l-produzzjoni ta' Bcl-2, kienet mistennija li tagħmel iċ-ċelloli tal-kanċer aktar sensittivi għal fatturi li jikkaġunaw mewt taċ-ċelloli, inklużi mediċini kontra l-kanċer bħal ma hija dacarbazine.
English: There were side effects associated with treatment with Genasense.
Maltese: Kien hemm effetti sekondarji assoċjati mal-kura b'Genasense.
English: It attaches to the ‘messenger RNA' (mRNA) that normally instructs the cell how to make Bcl-2.
Maltese: Hija taqbad mal-‘RNA messaġġiera' (mRNA) li normalment tgħallem liċ-ċellola li tagħmel Bcl-2.
English: This protein normally allows skin cancer cells to stay alive by preventing them from committing suicide (apoptosis).
Maltese: Din il-proteina normalment tħalli ċelloli talkanċer jibqgħu ħajjin billi timpedixxihom milli jagħmlu suwiċidju (apoptożi).
English: It is thought to work by preventing cells from producing the protein Bcl-2.
Maltese: Hija maħsuba li taħdem billi timpedixxi ċelloli milli jipproduċu l-proteina Bcl-2.
English: In the main study of patients with melanoma, survival rates were very similar in the patients receiving Genasense with dacarbazine and those receiving dacarbazine alone.
Maltese: Fl-istudju ewlieni ta' pazjenti b'melanoma, ir-rati ta' sopravivenza kienu simili ħafna f'pazjenti li qed jirċievu Genasense ma' dacarbazine u dawk li qed jirċievu dacarbazine waħdu.
English: Therefore, the study did not demonstrate that Genasense was effective in treating melanoma.
Maltese: Għaldaqstant, l-istudju ma weriex li Genasense kienet effettiva biex tikkura l-melanoma.
English: Genasense was to be used to treat patients with melanoma (a type of skin cancer affecting cells called ‘melanocytes') whose disease is advanced (it cannot be removed by surgery alone) or metastatic (has spread to other parts of the body).
Maltese: Genasense kienet mistenni li tintuża biex titratta pazjenti b'melanoma (tip ta' kanċer tal-ġilda li jaffettwa ċelloli msejħa ‘melanoċiti') li l-marda tagħhom hija f'fażi avvanzata (ma tistax titneħħa bilkirurġija biss) jew metastatika (infirxet għal partijiet oħra tal-ġisem).
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Genasense?
Maltese: X'inhuma l-konsegwenzi tar-rifjut għal pazjenti fi provi kliniċi jew fi programm ta' kompassjoni li qed jużaw Genasense?
English: This stimulates the cell to destroy the mRNA, blocking the production of the protein.
Maltese: Din tistimola liċ-ċellola biex teqred l-mRNA, u timblokka l-produzzjoni tal-proteina.
English: The effects of Genasense were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Genasense ġew l-ewwel ittestjati f'mudelli esperimentali qabel ma kienu studjati filbnedmin.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Genasense.
Maltese: Il-kumpanija infurmat lis-CHMP li ma hemmx konsegwenzi għal pazjenti li bħalissa huma inklużi fi provi kliniċi jew fi programm ta' użu ta' kompassjoni b'Genasense.
English: The effects of Genasense in combination with dacarbazine were compared with those of dacarbazine taken alone.
Maltese: L-effetti ta' Genasense f'kumbinazzjoni ma' dacarbazine ġew imqabbla ma' dawk ta' dacarbazine meħud waħdu.
English: Centaury EMA/824095/2015
Maltese: Ċentawrja EMA/824095/2015
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2 ta' Frar 2016
English: Centaury
Maltese: Ċentawrja
English: 2 February 2016 EMA/824095/2015
Maltese: EMA/824095/2015
English: Further information on the risks associated with centaury medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini li fihom iċ-ċentawrja, inklużi l-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab "Id-dokumenti kollha" fil-websajt talAġenzija: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Centaury is the common name for the plant Centaurium erythraea Rafn.
Maltese: Ċentawrja huwa l-isem komuni għall-pjanta Centaurium erythraea Rafn.
English: Studies in laboratory tests indicate an effect as appetite and digestion stimulant, although the data available are very limited.
Maltese: Studji permezz ta' testijiet tal-laboratorju jindikaw effett bħala stimulant tal-aptit u tad-diġestjoni, għalkemm l-informazzjoni disponibbli hija limitata ħafna.
English: What is centaury?
Maltese: X'inhi ċentawrja?
English: What are the risks associated with centaury medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini li fihom iċ-ċentawrja?
English: They are also obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (such as ethanol or water) to form a liquid extract or tincture (an alcoholic extract).
Maltese: Jinkisbu wkoll permezz ta' teknika għall-estrazzjoni talkomponenti minn materjal ta' pjanta billi dawn jinħallu f'solvent (bħal etanol jew ilma) biex jifforma estratt likwidu jew tintura (estratt alkoħoliku).
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, leffikaċja ta' dawn il-mediċini tal-ħxejjex hija plawżibbli u hemm evidenza li ilhom jintużaw b'mod sigur b'dan il-mod għal mill-inqas 30 sena (inkluż mill-inqas 15-il sena fl-UE).
English: Further information on the HMPC assessment of centaury medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini li fihom iċ-ċentawrja, inklużi d-dettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' fil-websajt tal-Aġenzija:
English: Other information about centaury medicines
Maltese: Informazzjoni oħra dwar il-mediċini li fihom iċ-ċentawrja
English: The HMPC conclusions on the use of centaury medicines for indigestion or other stomach and gut disorders, and in temporary loss of appetite are based on their ‘traditional use'.
Maltese: Fiż-żmien tal-valutazzjoni tal-HMPC, ebda effett sekondarju ma kien ġie rrappurtat b'dawn il-mediċini.
English: Any applications for the licensing of medicines containing centaury have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom iċ-ċentawrja għandha titressaq lillawtoritajiet nazzjonali responsabbli mill-prodotti mediċinali, li ser jivvalutaw l-applikazzjoni għallmediċina tal-ħxejjex u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing centaury.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC noted the lack of clinical studies with centaury.
Maltese: Kif jiġu approvati fl-UE l-mediċini li fihom iċ-ċentawrja?
English: (Invented) name
Maltese: Isem (inventat)
English: Content (concentration) Pack size
Maltese: Kontenut (konċentrazzjoni) Daqs tal-pakkett
English: Packaging Package size bottle (HDPE) 168 (4 x 42) tablets bottle (HDPE) 42 tablets
Maltese: Pillola miksija b'rita Għoti mill-ħalq flixkun (HDPE) 168 (4 x 42) pillola
English: Route of Administration
Maltese: Daqs tal-Pakkett
English: Date of latest renewal: 18 November 2016
Maltese: Data tal-aħħar tiġdid: 18 ta' Novembru 2016
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/727/001
Maltese: EU/1/11/727/001
English: Oral suspension.
Maltese: Sospensjoni orali.
English: BSA (m2) Dose (mg)
Maltese: BSA (m2) Doża (mg)
English: See also section 4.
Maltese: Ara wkoll sezzjoni 4.
English: Pancreatitis, oral ulceration
Maltese: Pankreatite, ulċeri orali
English: (≥1/1000 to < 1/100), rare (≥1/10,000 to < 1/1000) and very rare (< 1/10,000).
Maltese: (≥1/100 sa < 1/10), mhux komuni (≥1/1000 sa < 1/100), rari (≥1/10,000 sa < 1/1000) u rari ħafna (< 1/10,000).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 March 2012
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 09 ta' Marzu 2012
English: - anti-epileptic medicines such as phenytoin, carbamazepine.
Maltese: - mediċini anti-epilettiċi bħal phenytoin, carbamazepine.
English: System organ class
Maltese: Klassi tas-sistemi tal-organi
English: Transient oligospermia
Maltese: Oligospermia temporarja
English: Cross-resistance usually exists between 6-mercaptopurine and 6-thioguanine.
Maltese: Normalment teżisti kross-resistenza bejn 6-mercaptopurine u 6-thioguanine.
English: MIAS Pharma Limited Suite 2, Stafford House, Strand Road Postmarnock, Co. Dublin D13H525
Maltese: MIAS Pharma Limited Suite 2, Stafford House, Strand Road Postmarnock, Co.
English: The apparent body clearance is 4832 ± 2562 ml/min/m2.
Maltese: It-tneħħija apparenti mill-ġisem hija ta' 4832 ± 2562 ml/min/m2.
English: 6-mercaptopurine is metabolised by the polymorphic TPMT enzyme.
Maltese: 6-mercaptopurine huwa metabolizzat mill-enzima polimorfika TPMT.
English: Intestinal ulceration
Maltese: Ulċeri intestinali
English: Immunosuppression
Maltese: Immunosuppressjoni
English: The frequency of NUDT15 c.415C>T has an ethnic variability of approximately 10 % in East Asians, 4 % in Hispanics, 0.2 % in Europeans and 0 % in Africans.
Maltese: Il-frekwenza ta' NUDT15 c.415C> għandha varjabbiltà etnika ta' madwar 10 % f'Asjatiċi tal-Lvant, 4 % fl-Ispaniċi, 0.2 % fl-Ewropej u 0 % fl-Afrikani.
English: The active substance is mercaptopurine (as monohydrate).
Maltese: Is-sustanza attiva hija mercaptopurine (bħala monohydrate).
English: D01 W2T2
Maltese: L01BB02
English: Hepatosplenic T-cell lymphoma* (see section 4.4)
Maltese: epatosplenika* (ara sezzjoni 4.4)
English: Safe handling of the suspension
Maltese: Immaniġġar sigur tas-sospensjoni
English: EXPIRY DATE
Maltese: Data miftuħa
English: Nova Laboratories Limited Martin House, Gloucester Crescent Wigston, Leicester LE18 4YL
Maltese: Nova Laboratories Limited Martin House, Gloucester Crescent
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, purine analogues, ATC code: L01BB02
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, antimetaboliti, analogi ta' purine, Kodiċi ATC:
English: Foley Street, Dublin 1
Maltese: Floor, Ulysses House Foley Street, Dublin 1 D01 W2T2
English: Xaluprine contains aspartame (E951) which contains a source of phenylalanine.
Maltese: Xaluprine fih aspartame (E951) li fih sors ta' phenylalanine.
English: When oral anticoagulants are coadministered with 6-mercaptopurine, a reinforced monitoring of INR (International Normalised Ratio) is recommended (see section 4.5).
Maltese: Meta anti-koagulanti orali jingħataw flimkien ma' 6-mercaptopurine, huwa rrakkomandat monitoraġġ imsaħħaħ ta' INR (Proporzjon Normalizzat Internazzjonali) (ara sezzjoni 4.5).
English: Both TIMP and mTIMP are inhibitors of phosphoribosyl pyrophosphate amidotransferase, an enzyme which is important in de novo purine synthesis.
Maltese: Kemm TIMP kif ukoll mTIMP huma inibituri ta' phosphoribosyl pyrophosphate amidotransferase, enzima li hija importanti fis-sinteżi de novo ta' purine.
English: Mutagenicity and carcinogenicity
Maltese: Mutaġeniċità u karċinoġeniċità
English: INFORMATION IN BRAILLE Xaluprine 20 mg/ml
Maltese: Xaluprine 20 mg/ml
English: Xaluprine 20 mg/ml oral suspension mercaptopurine
Maltese: Xaluprine 20 mg/ml sospensjoni orali mercaptopurine
English: Xanthine oxidase is the main catabolic enzyme and it converts the 6-mercaptopurine into the inactive metabolite, 6-thiouric acid.
Maltese: Xanthine oxidase huwa l-enzima katabolika ewlenija u jikkonverti lil 6-mercaptopurine fil-metabolit inattiv, 6-thiouric acid.
English: Stomatitis, diarrhoea, vomiting, nausea
Maltese: Stomatite, dijarea, rimettar, nawżja.
English: This medicinal product contains aspartame (E951), a source of phenylalanine.
Maltese: Dan il-prodott mediċinali fih aspartame (E951), sors ta' phenylalanine.
English: The elimination half-life of 6-mercaptopurine is 90 ± 30 minutes, but the active metabolites have a longer half-life (approximately 5 hours) than the parent compound.
Maltese: Il-half-life ta' eliminazzjoni ta' 6-mercaptopurine hija ta' 90 ± 30 minuta, iżda l-metaboliti attivi għandhom half-life itwal (madwar 5 sigħat) mill-kompost prinċipali.
English: Shake vigorously before use for at least 30 seconds.
Maltese: Ħawwad sew qabel l-użu għal mill-inqas 30 sekonda.
English: The usual starting dose for adults, adolescents and children is between 25-75 mg/m2 body surface area each day.
Maltese: Id-doża normali tal-bidu għalladulti, l-adoloxxenti u t-tfal hija bejn 25-75 mg/m2 tas-superfiċje tal-ġisem kuljum.
English: Macrophage activation syndrome
Maltese: Sindrome tal-attivazzjoni tal-makrofagu
English: Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.
Maltese: Xaluprine huwa indikat fil-kura ta' lewkimja limfoblastika akuta (ALL) fl-adulti, l-adoloxxenti u ttfal.
English: 6-mercaptopurine, in common with other antimetabolites, is mutagenic and causes chromosomal aberrations in vitro and in vivo in mice and rats.
Maltese: 6-mercaptopurine, komuni ma' antimetaboliti oħra, huwa mutaġeniku u jikkawża abnormalitajiet kromosomali in vitro u in vivo fil-ġrieden u l-firien.
English: Xaluprine contains sucrose.
Maltese: Xaluprine fih is-sucrose.
English: Some laboratories offer testing for TPMT deficiency, although these tests have not been shown to identify all patients at risk of severe toxicity.
Maltese: Ċerti laboratorji joffru ttestjar għal defiċjenza ta' TPMT, għalkemm dawn it-testijiet ma ntwerewx li jidentifikaw il-pazjenti kollha li qegħdin f'riskju ta' tossiċità severa.
English: Patients with inherited mutated NUDT15 gene are at increased risk for severe 6-mercaptopurine toxicity, (see 4.4).
Maltese: Il-pazjenti li wirtu ġene NUDT15 mutant jinsabu f'riskju miżjud għal tossiċità b'6-mercaptopurine severa, (ara 4.4).
English: TPMT also catalyses the S-methylation of the principle nucleotide metabolite, TIMP, to form methylthioinosine monophosphate (mTIMP).
Maltese: Madanakollu, TPMT jikkatalizza wkoll isS-methylation tal-metabolit ewlieni tan-nukleotide, TIMP, biex jifforma methylthioinosine monophosphate (mTIMP).
English: • Risk Management Plan (RMP) Not applicable
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Mhux applikabbli.
English: One ml of suspension contains 3 mg aspartame, 1 mg methyl hydroxybenzoate (as the sodium salt), 0.5 mg ethyl hydroxybenzoate (as the sodium salt) and sucrose (trace).
Maltese: Ml wieħed ta' sospensjoni fih 3 mg aspartame, 1 mg methyl hydroxylbenzoate (bħala l-melħ tas-sodju), 0.5 mg ethyl hydroxybenzoate (bħala l-melħ tas-sodju) u sucrose (traċċa).
English: How to store Xaluprine
Maltese: X'fih Xaluprine
English: 4.3 Contraindications
Maltese: Xaluprine. 4.3 Kontraindikazzjonijiet
English: Pancreatitis in off-label treatment of patients with inflammatory bowel disease Pancreatitis has been reported to occur at a frequency of ≥ 1/100 to < 1/10 (“common”) in patients treated for the unlicensed indication inflammatory bowel disease.
Maltese: Il-pankreatite f'kura mhux ittikkettata ta' pazjenti b'mard infjammatorju tal-musrana Pankreatite ġiet irrapportata li sseħħ bi frekwenza ta' ≥ 1/100 sa < 1/10 (“komuni”) f'pazjenti kkurati għall-indikazzjoni mhux liċenzjata mard infjammatorju tal-musrana.
English: The bioavailability of oral 6-mercaptopurine shows considerable inter-individual variability, which probably results from its first-pass metabolism.
Maltese: Assorbiment Il-bijodisponibilità ta' 6-mercaptopurine orali turi varjabilità inter-individwali konsiderevoli, li probabbilment tirriżulta mill-metaboliżmu tal-ewwel mogħdija tiegħu.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Nova Laboratories Ireland Limited
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Nova Laboratories Ireland Limited rd
English: Patients with inherited mutated NUDT15 gene are at increased risk for severe 6-mercaptopurine toxicity, such as early leukopenia and alopecia, from conventional doses of thiopurine therapy.
Maltese: Il-pazjenti li wirtu ġene NUDT15 mutanti jinsabu f'riskju miżjud għal tossiċità b'6-mercaptopurine severa, bħal lewkopenija u alopeċja, minn dożi konvenzjonali ta' terapija b'thiopurine.
English: Other side effects (the frequency is unknown) - a rare type of cancer (hepatosplenic T-cell lymphoma), (see section 2, Warnings and
Maltese: Effetti sekondarji oħrajn (frekwenza mhux magħrufa) - tip rari ta' kanċer (limfoma taċ-ċellola-T epatosplenika), (ara sezzjoni 2, Twissijiet u prekawzjonijiet).
English: The other ingredients are xanthan gum, aspartame (E951), concentrated raspberry juice, sucrose, sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215), potassium sorbate (E202), sodium hydroxide and purified water (see section 2 Xaluprine contains aspartame, sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215) and sucrose).
Maltese: Is-sustanzi l-oħra huma gomma ta' xanthan, aspartame (E951), meraq ikkonċentrat tal-lampun, sukrosju, sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215), potassium sorbate (E202), sodium hydroxide u ilma ppurifikat (ara sezzjoni 2 għal aktar tagħrif dwar aspartame , sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215) u sucrose).
English: The intracellular anabolism of 6-merpactopurine is catalysed by several enzymes to eventually form 6-thioguanine nucleotides (TGNs), but a variety of intermediary TGNs are formed en route to the TGNs.
Maltese: L-anaboliżmu intraċellulari ta' 6-merpactopurine huwa kkatalizzat minn bosta enzimi biex eventwalment jiffurmaw in-nukleotidi ta' 6-thioguanine (TGNs), iżda fil-proċess għat-TGNs jiġu ffurmati varjetà ta' TGNs intermedjarji.
English: Xaluprine contains aspartame, sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215) and sucrose
Maltese: Xaluprine fih aspartame, sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215) u sucrose
English: Combination with xanthine oxidase inhibitors
Maltese: Barra minn hekk inibituri oħra ta' xanthine oxidase,
English: Facial oedema
Maltese: Reazzjoni avversa
English: There are individuals with an inherited deficiency of the TPMT enzyme activity who are very sensitive to the myelosuppresive effect of 6-mercaptopurine and prone to developing rapid bone marrow depression following the initiation of treatment with 6-mercaptopurine.
Maltese: Hemm individwi li wirtu defiċjenza tal-attività tal-enzima TPMT li huma sensittivi ħafna għall-effett majelosuppresiv ta' 6-mercaptopurine u suxxettibbli għall-iżvilupp ta' dipressjoni rapida tal-mudullun wara l-bidu ta' kura bi 6-mercaptopurine.
English: The 6-mercaptopurine metabolites inhibit de novo purine synthesis and purine nucleotide interconversions.
Maltese: Il-metaboliti ta' 6-mercaptopurine jinibixxu s-sinteżi de novo ta' purine u l-interkonverżjonijiet tan-nukleotidi ta' purine.
English: There have also been reports of congenital abnormalities and spontaneous abortion following either maternal or paternal exposure.
Maltese: Kien hemm ukoll rapporti ta' abnormalitajiet konġenitali u abort spontanju wara l-espożizzjoni jew tal-omm jew tal-missier.
English: Also contains: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215), potassium sorbate (E202), sodium hydroxide, aspartame (E951) and sucrose.
Maltese: Fih ukoll: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215), potassium sorbate (E202), sodium hydroxide, aspartame (E951) u sucrose.
English: Hypoglycaemia†
Maltese: Ipogliċemija†
English: In a comparative bioavailability study in healthy adult volunteers (n=60), 50mg of Xaluprine oral suspension was demonstrated to be bioequivalent to the reference 50mg tablet for AUC, but not Cmax.
Maltese: Fi studju komparattiv ta' bijodisponibilità fuq voluntiera adulti b'saħħithom (n=60), 50mg ta'
English: 6-mercaptopurine is an inactive pro-drug which acts as a purine antagonist but requires cellular uptake and intracellular anabolism to thioguanine nucleotides for cytotoxicity.
Maltese: 6-mercaptopurine huwa pro-mediċina inattiva li taġixxi bħala antagonist ta' purine imma teħtieġ it-teħid ċellulari u l-anaboliżmu intraċellulari għan-nukleotidi ta' thioguanine biex issir ċitotossika.
English: Transient profound oligospermia has been reported following exposure to 6-mercaptopurine in combination with corticosteroids.
Maltese: Ġiet irrapportata oligospermia profonda temporanja wara l-espożizzjoni għal 6-mercaptopurine f'kombinazzjoni ma' kortikosterojdi.
English: The adverse reactions are displayed by system organ class and frequency: very common (≥1/10), common (≥1/100 to < 1/10), uncommon
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi u l-frekwenza: komuni ħafna (≥1/10), komuni
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini..
English: Aspartame (E951)
Maltese: 6.1 Lista ta' eċċipjenti Gomma ta' Xanthan Aspartame (E951)
English: Xaluprine contains mercaptopurine.
Maltese: Xaluprine huwa ċitotossiku.
English: Uncommon (affects less than 1 in 100 people) - mouth ulcers - inflamed pancreas - joint pain - skin rash - fever - permanent damage to the liver (hepatic necrosis)
Maltese: Mhux komuni (jaffetwaw anqas minn persuna 1 minn kull 100) - ulċeri fil-ħalq - frixa infjammata - uġigħ fil-ġogi - raxx fuq il-ġilda - deni - ħsara permanenti lill-fwied (nekrożi epatika)
English: Keep the bottle tightly closed (see section 6.6).
Maltese: (ara sezzjoni 6.6).
English: Careful monitoring of the phenytoin serum levels is recommended.
Maltese: Huwa rrakkomandat li jsir monitoraġġ bir-reqqa tal-livelli ta' phenytoin fis-serum.
English: 6-mercaptopurine displays diurnal variation in pharmacokinetics and efficacy.
Maltese: 6-mercaptopurine juri varjazzjoni diurnali fir-rigward tal-farmakokinetika u l-effikaċja.