FrancophonIA/ELRC3.0 huggingface dataset:
English: There is insufficient clinical information available for Cufence to determine whether there exist differences in responses between the elderly and younger patients.
Maltese: M'hemmx biżżejjed informazzjoni klinika disponibbli għal Cufence biex jiġi ddeterminat jekk jeżistux differenzi fir-risponsi bejn l-anzjani u pazjenti iżgħar fl-età.
English: Due date neurologic or psychiatric symptoms as well as in paediatric patients, the MAH should conduct and submit the results of an open label, prospective study to investigate the clinical course of hepatic, neurological and psychiatric disease from the time of initiation of treatment with trientine dihydrochloride up to 24 months of therapy.
Maltese: newroloġiċi jew psikjatriċi kif ukoll f'pazjenti pedjatriċi, il-MAH għandu jwettaq u jissottometti r-riżultati ta' studju open-label, prospettiv biex jinvestiga l-kors kliniku tal-marda epatika, newroloġika u psikjatrika minn meta tinbeda l-kura bi trientine dihydrochloride sa 24 xahar ta' terapija.
English: The dose should be adjusted according to clinical response; 400 - 1,000 mg have been used at initiation of therapy.
Maltese: Id-doża għandha tiġi aġġustata skont ir-rispons kliniku; intużaw 400 - 1,000 mg fil-bidu tat-terapija (ara sezzjoni 4.4).
English: How to take Cufence
Maltese: Mediċini oħra u Cufence
English: No fertility data are available but estrous cyclicity was unaffected and reproductive organs were not identified as target organs in general repeat dose toxicity studies.
Maltese: Ma hemm ebda dejta disponibbli dwar il-fertilità, iżda ċ-ċikliċità estruża ma kinitx affettwata u lorgani riproduttivi ma ġewx identifikati bħala l-organi fil-mira fi studji ġenerali tat-tossiċità b'doża ripetuta.
English: Pack size: 1 bottle of 100 hard capsules.
Maltese: Daqs tal-pakkett: flixkun wieħed ta' 100 kapsula iebsa.
English: Concomitant oral iron should be administred at a different time than trientine (see section 4.5).
Maltese: Ħadid orali konkomitanti għandu jingħata f'ħin differenti minn trientine (ara sezzjoni 4.5).
English: You and your doctor should fully discuss the potential benefits of treatment whilst considering any possible risks that there may be.
Maltese: Int u t-tabib tiegħek għandkom tiddiskutu bis-sħiħ il-benefiċċji potenzjali tat-trattament waqt li tqisu kwalunkwe riskju possibbli li jista' jkun hemm.
English: Unabsorbed trientine is bound to intestinal copper and eliminated through faecal excretion.
Maltese: Trientine mhux assorbit jintrabat mar-ram intestinali u jiġi eliminat bl-eskrezzjoni tar-rawt.
English: The safety and efficacy of Cufence in children aged 0 to 5 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Cufence fit-tfal minn età ta' 0 sa 5 snin ma ġewx determinati s'issa.
English: Cufence is a medicine used for the treatment of Wilson's disease in adults, adolescents and children aged 5 years or older.
Maltese: Cufence hu mediċina użata għat-trattament tal-marda ta' Wilson fl-adulti, fl-adoloxxenti u fit-tfal ta' 5 snin jew aktar.
English: The usual dose is between 4 and 8 capsules per day, to be taken by mouth.
Maltese: Id-doża normalment hi bejn 4 u 8 kapsuli kull jum, li għandhom jinbelgħu.
English: The use of appropriate copper parameter target ranges is described in clinical practice guidelines related to Wilson's disease.
Maltese: L-użu ta' meded fil-mira tal-parametru ta' ram xierqa huwa deskritt fil-linji gwida tal-prassi klinika relatati mal-marda ta' Wilson.
English: There is limited information in patients with renal impairment.
Maltese: L-informazzjoni hi limitata f'pazjenti b'indeboliment renali.
English: Not known: Lupus-like syndrome
Maltese: Sindrome bħal lupus
English: Non-clinical data reveal no special hazard for humans based on a series of studies investigating cardiovascular safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to embryofoetal development.
Maltese: Tagħrif mhux kliniku ibbażat fuq sensiela ta' studji li jinvestigaw is-sigurtà farmakoloġika kardjovaskulari, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni u effett tossiku fuq liżvilupp embrijofetali.
English: Studies in animals have shown reproductive toxicity, which was probably a result of trientine-induced copper deficiency (see section 5.3).
Maltese: L-istudji fl-annimali wrew tossiċità riproduttiva, li aktarx kienet riżultat ta' insuffiċjenza fir-ram indotta minn trientine (ara sezzjoni 5.3).
English: Each hard capsule is white, oval-shaped size 0 with Cufence 200 printed in grey ink.
Maltese: Kull kapsula iebsa hi bajda, ta' forma ovali u ta' daqs 0 b'Cufence 200 stampati fuqha b'linka griża.
English: Lupus-like reactions (symptoms may include persistent rash, fever, joint pain, and tiredness) have been reported in some patients switched to trientine medicine after penicillamine medicine.
Maltese: Ġew irrappurtati reazzjonijiet bħal tal-lupus (is-sintomi jistgħu jinkludu raxx persistenti, deni, uġigħ fil-ġogi, u għeja) f'xi pazjenti li qalbu għal mediċina ta' trientine wara mediċina ta' penicillamine.
English: Trientine is a copper-selective chelator that enhances systemic elimination of divalent copper by forming a stable complex that is readily excreted by the kidneys.
Maltese: Trientine hu kelatur selettiv tar-ram li jsaħħaħ l-eliminazzjoni sistemika tar-ram divalenti billi jifforma kumpless stabbli li jiġi eskretat minnufih mill-kliewi.
English: Not known: Lupus nephritis
Maltese: F'dan il-fuljett
English: Trientine has low human plasma protein binding and is widely distributed in tissues with relatively high concentrations measured in liver, heart, and kidney in the rat.
Maltese: Trientine hu legant baxx mal-proteina tal-plażma umana u jitqassam komunement f'essuti b'konċentrazzjonijiet relattivament għoljin imkejla fil-fwied, fil-qalb u fil-kliewi fil-firien.
English: In dogs, ataxia, tremors, abnormal gait and underactivity were observed following administration of very high levels of trientine.
Maltese: Fil-klieb ġew osservati atassija, rogħda, mixi anormali u attività mnaqqsa wara l-amministrazzjoni ta' livelli għoljin ħafna ta' trientine.
English: Occasionally (frequency unknown; cannot be estimated from available data), treatment with this medicine can cause inflammation of the small intestine or colon.
Maltese: Kultant (frekwenza mhux magħrufa; ma tistax tiġi stmata mid-data disponibbli), it-trattament b'din ilmediċina jista' jikkawża infjammazzjoni tal-intestin iż-żgħir jew tal-kolon.
English: Concomitant oral iron or other heavy metals should be administred at a different time than trientine to prevent the formation of complexes (see section 4.4).
Maltese: Ħadid orali jew metalli tqal oħra konkomitanti għandhom jingħataw f'ħin differenti minn trientine biex tiġi evitata l-formazzjoni ta' kumplessi (ara sezzjoni 4.4).
English: Germany
Maltese: In-Netherlands
English: Trientine is metabolised by acetylation via spermidine/spermine N-acetyltransferase and not via N-acetyltransferase 2.
Maltese: Trientine jiġi metabolizzat b'aċetilazzjoni permezz ta' N-aċetiltransferażi spermidina/spermina u mhux permezz ta' N-aċetiltransferażi 2.
English: The OECD SIDS triethylenetetramine 2002 classifies the genotoxic profile of trientine as low priority/concern.
Maltese: L-SIDS tal-2002 tal-OECD dwar it-trietilenetetrammina jikklassifika l-profil ġenotossiku ta' trientine bħala ta' prijorità baxxa/ta' livell baxx ta' tħassib.
English: How to store Cufence
Maltese: Tiħux Cufence:
English: Trientine is a chelator with a polyamine-like structure and copper is chelated by forming a stable complex with the four constituent nitrogens in a planar ring.
Maltese: Trientine hu kelatur bi struttura bħall-poliamina u r-ram jiġi kelat billi jiġi fformat kumpless stabbli bl-erba' nitroġeni kostitwenti fiċ-ċirku planari.
English: Trientine should be used in pregnancy only after careful consideration of the benefits compared with the risks of discontinuing treatment in the individual patient.
Maltese: Trientine għandu jintuża fit-tqala biss wara kunsiderazzjoni bir-reqqa tal-benefiċċji meta mqabbla mar-riskji ta' waqfien tat-trattament fil-pazjent individwali.
English: In the event of overdose the patient should be observed, appropriate biochemical analysis performed and symptomatic treatment given.
Maltese: Fil-każ ta 'doża eċċessiva il-pazjent għandu jkun osservat, titwettaq analiżi bijokimika xierqa u jingħata trattament sintomatiku.
English: Dose adjustments in the trientine dose should be considered in case of signs of reduced efficacy such as (persistent) increase in liver enzymes, and worsening of tremor.
Maltese: Aġġustamenti fid-doża ta' trientine għandhom jiġu kkunsidrati f'każ ta' sinjali ta' effikaċja mnaqqsa bħal żieda (persistenti) fl-enzimi tal-fwied, u aggravar tar-rogħda.
English: In patients who were previously treated with D-Penicillamine, lupus-like reactions have been reported during subsequent treatment with trientine, however it is not possible to determine if there is a causal relationship with trientine.
Maltese: F'pazjenti li preċedentement ġew ikkurati b'D-Penicillamine, ġew irrappurtati reazzjonijiet bħal tallupus waqt trattament sussegwenti b'trientine, madankollu mhuwiex possibbli li jiġi determinat jekk hemmx relazzjoni kawżali ma' trientine.
English: The limited information available suggests that Cufence does not pass into breast milk, but it is not certain that there is no risk to the baby.
Maltese: L-informazzjoni limitata disponibbli tissuġġerixxi li Cufence ma jgħaddix mal-ħalib tas-sider, iżda mhuwiex ċert li ma hemm ebda riskju għat-tarbija.
English: Package leaflet: Information for the patient Cufence 200 mg hard capsules trientine
Maltese: Informazzjoni għall-pazjent Cufence 200 mg kapsuli ibsin trientine
English: Patients receiving Cufence should remain under regular medical supervision and be monitored using all available clinical data for appropriate control of clinical symptoms and copper levels in order to optimise treatment.
Maltese: Il-pazjenti li jirċievu Cufence għandhom jibqgħu taħt superviżjoni medika regolari u jiġu ssorveljati bl-użu tad-data klinika disponibbli kollha għall-kontroll xieraq tas-sintomi kliniċi u tal-livelli tar-ram biex jiġi ottimizzat it-trattament.
English: There are insufficient data to support the concomitant use of zinc and trientine.
Maltese: Ma hemmx biżżejjed dejta li ssostni l-użu konkomitanti taż-żingu u ta' trientine.
English: The principal mechanism of action of trientine requires its systemic exposure (see section 5.1) so it is recommended that trientine be taken at least 1 hour before meals or 2 hours after meals and at least one hour apart from any other medicinal product, food, or milk to allow for maximum absorption and reduce the likelihood of the formation of complexes by metal binding in the gastrointestinal tract (see section 4.2).
Maltese: Il-mekkaniżmu prinċipali ta' azzjoni ta' trientine jeħtieġ l-esponiment sistemiku tiegħu (ara sezzjoni 5.1) u għalhekk hu rakkomandat li trientine jittieħed tal-anqas siegħa (1) qabel l-ikliet jew sagħtejn (2) wara l-ikliet u talanqas siegħa (1) qabel jew wara kwalunkwe prodott mediċinali ieħor, ikel, jew ħalib biex jinkiseb lassorbiment massimu u titnaqqas il-probabbiltà tal-formazzjoni ta' kumplessi mil-legatura tal-metall fl-apparat gastrointestinali (ara sezzjoni 4.2).
English: If treatment with trientine is to be continued following a risk-benefit analysis, consideration should be given to reducing the dose of trientine to the lowest effective dose and monitoring compliance with the treatment regimen.
Maltese: Jekk it-trattament bi trientine jkun se jitkompla wara analiżi tar-riskji u tal-benefiċċji, għandha tingħata kunsiderazzjoni lit-tnaqqis tad-doża ta' trientine sal-anqas doża effettiva u lill-monitoraġġ tal konformità mar-reġimen tat-trattament.
English: Moreover, there is evidence to suggest that trientine actually reduces endogenous DNA damage in a strain of rat (Long-Evans Cinnamon) considered to represent an appropriate model of Wilson's disease.
Maltese: Barra minn hekk, hemm evidenza li tissuġġerixxi li trientine fil-fatt inaqqas il-ħsara endoġena fid-DNA f'razza ta' firien (Long-Evans Cinnamon) meqjusa li tirrappreżenta mudell xieraq tal-marda ta' Wilson.
English: Patients with renal and/or hepatic impairment receiving trientine should remain under regular medical supervision for appropriate control of symptoms and copper levels.
Maltese: Pazjenti b'indeboliment renali u/jew epatiku li jirċievu trientine għandhom jibqgħu taħt superviżjoni medika regolari għal kontroll xieraq tas-sintomi u tal-livelli ta' ram.
English: Shellac
Maltese: Lupus
English: There are only limited data on concomitant use available and no specific dose recommendations can be made.
Maltese: Id-data disponibbli dwar l-użu konkomitanti hi limitata u ma tista' ssir ebda rakkomandazzjoni dwar doża speċifika.
English: When switching a patient from another trientine formulation, caution is advised because different trientine salts are available which may have a different trientine content (base) and a different bioavailability.
Maltese: Meta pazjent jinqaleb għal dan it-trattament minn formulazzjoni oħra bi trientine, hu rakkomandat li dan isir bil-galbu għaliex hemm disponibbli mluħ differenti ta' trientine li jista' jkollhom (bażi ta') kontenut differenti ta' trientine u bijodisponibbiltà differenti.
English: Following oral administration, trientine absorption is low and variable in patients with Wilson's disease.
Maltese: Wara l-amministrazzjoni orali, l-assorbiment ta' trientine jkun baxx u varjabbli f'pazjenti bil-marda ta' Wilson.
English: Nervous system problems can occur (for example, shaking, lack of coordination, slurred speech, muscle stiffness and worsening of muscle spasms), especially in patients just starting treatment with Cufence.
Maltese: Jistgħu jseħħu problemi fis-sistema nervuża (pereżempju, rogħda, nuqqas ta' koordinazzjoni, tlissin imħawwad, ebusija tal-muskoli u deterjorament tal-ispażmi tal-muskoli), speċjalment f'pazjenti li jkunu għadhom kif jibdew it-trattament b'Cufence.
English: Uncommon (may affect up to 1 in 100 people) - Skin rashes - Anaemia (you may feel unusually tired)
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna (1) f'100) - Raxxijiet tal-ġilda - Anemija (tista' tħoss aktar għeja mis-soltu)
English: Printing ink:
Maltese: Mhux magħrufa:
English: Pregnancy There is a limited amount of data from the use of trientine in pregnant women.
Maltese: Tqala Hemm ammont limitat ta' data mill-użu ta' trientine f'nisa tqal.
English: Common (may affect up to 1 in 10 people) - Nausea (especially when starting treatment)
Maltese: Komuni (jistgħu jaffettwaw sa persuna (1) f'10) - Nawsja (speċjalment meta tkun għadek tibda t-trattament)
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Amber glass bottle with a polypropylene cap and induction heat seal liner with a sachet of dried silica gel as desiccant.
Maltese: L-istudju ser jinkludi wkoll substudju PK/PD biex jevalwa r-relazzjoni bejn id-doża u r-rispons speċjalment waqt il-fażi tat-titrazzjoni 'l fuq.
English: Effects in non-clinical studies were largely consistent with induced copper deficiency in the plasma and liver of previously copper normative animals and as such could be attributed to the pharmacological action of trientine.
Maltese: L-effetti fi studji mhux kliniċi kienu primarjaemnt konsistenti ma' insuffiċjenza indotta tar-ram filplażma u fil-fwied ta' annimali li qabel kienu normattivi fir-ram u, b'hekk, setgħu jiġu attribwti għallazzjoni farmakoloġika ta' trientine.
English: Trientine is a chelating agent which has been found to reduce serum iron levels.
Maltese: Trientine hu aġent kelanti li nstab li jnaqqas il-livelli ta' ħadid tas-serum.
English: Cufence attaches to the copper, which is then passed from the body.
Maltese: Jekk tieħu aktar mediċina milli suppost, jistgħu jaqbduk nawsja, remettar u sturdament.
English: However, up titration should be done with moderation and consideration, and adapted according to the patient's clinical response such as worsening of tremor as patients could be at risk of neurological deterioration at initiation of treatment (see section 4.4).
Maltese: Madankollu, it-titrazzjoni 'l fuq għandha ssir b'moderazzjoni u b'kunsiderazzjoni, u tiġi adattata skont ir-rispons kliniku talpazjent bħall-aggravar tar-rogħda peress li l-pazjenti jistgħu jkunu f'riskju ta' deterjorament newroloġiku fil-bidu tat-trattament (ara sezzjoni 4.4).
English: The trientine dose may also be reduced in case of side effects of trientine, such as gastrointestinal complaints and haematological changes.
Maltese: Id-doża ta' trientine tista' titnaqqas ukoll f'każ ta' effetti sekondarji ta' trientine, bħal problemi gastrointestinali u tibdiliet ematoloġiċi.
English: *Referral EMEA/H/A-31/1463
Maltese: *Riferiment EMEA/H/A-31/1463
English: Contains E214 and E219.
Maltese: Fih E214 u E219.
English: Date of first authorisation: 29 March 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 29 Marzu 2017
English: Lymphoma1
Maltese: Linfoma1
English: Very common (≥1/10) Common (≥ 1/100 to <1/10) Uncommon (≥1/1,000 to < 1/100) Rare (≥1/10,000 to <1/1,000)
Maltese: Mhux komuni (≥1/1,000 to < 1/100) Rari (≥1/10,000 to <1/1,000)
English: Severe toxic manifestations:
Maltese: Manifestazzjonij iet tossiċi severi:
English: Immune system
Maltese: Is-sistema immuni
English: − seizures (convulsions)
Maltese: − aċċessjonijiet (konvulżjonijiet)
English: Megaloblastic anaemia
Maltese: Anemija megaloblastika
English: Oligospermia, Menstrual dysfunction
Maltese: Oligospermja, Disfunzjoni menstruwali
English: Methotrexate induces gene and chromosomal mutations in vitro and in vivo.
Maltese: Methotrexate jinduċi l-mutazzjonijiet fil-ġeni u kromosomali in vitro u in vivo.
English: • Causes of ME, severity and outcomes.
Maltese: • Kawżi ta' ME, severità u .riżultati.
English: Approximately 5-20% of methotrexate and 1-5% of 7-hydroxymethotrexate is eliminated in the bile.
Maltese: Madwar 5-20% ta' methotrexate u 1-5% ta' 7-hydroxymethotrexate jiġi eliminat fil-bili.
English: See also section 4 “Possible side effects”.
Maltese: Ara wkoll is-sezzjoni 4 “Effetti sekondarji possibbli”.
English: 1 can be reversible - see 4.4
Maltese: 1 tista' tkun riversibbli - ara 4.4
English: Stomatitis, Dyspepsia
Maltese: Stomatite, Dispepsja
English: Vitamin products
Maltese: Prodotti tal-vitamini
English: Nocardiosis, Histoplasma and cryptococcus mycosis, Disseminated herpes simplex
Maltese: Histoplasma u cryptococc us mycosis, Herpes simplex disseminat
English: Tabulated list of adverse reactions Frequencies in the table are defined according to the MedDRA convention:
Maltese: Il-frekwenzi fit-tabella huma definiti skont il-konvenzjoni MedDRA:
English: Methotrexate is approximately 50% bound to serum proteins.
Maltese: Methotrexate jeħel madwar 50 % mal-proteini tas-seru.
English: If bilirubin levels are >5 mg/dl (85.5 µmol/l), methotrexate is contraindicated (see sections 4.3 and 4.4).
Maltese: >5 mg/dl (85.5 µmol/l), methotrexate huwa kontraindikat (ara s-sezzjonijiet 4.3 u 4.4).
English: Creatinine clearance (ml/min)
Maltese: (ml/min)
English: • Active rheumatoid arthritis in adult patients.
Maltese: • Artrite rewmatika attiva f'pazjenti adulti
English: In addition, close monitoring of patients for possible early signs of toxicity is recommended (see sections 4.4, 4.5, 4.8 and 5.2).
Maltese: Barra minn hekk, huwa rrakkomandat monitoraġġ mill-qrib ta' pazjenti għal sinjali possibbli bikrija ta' tossiċità (ara s-sezzjonijiet 4.4, 4.5, 4.8 u 5.2).
English: For contraception advice for men see section 4.6.
Maltese: Għal parir fuq kontraċezzjoni fl-irġiel ara sezzjoni 4.6.
English: Teratogenicity - Reproductive risk
Maltese: Teratoġeniċità - Riskju għar-riproduzzjoni
English: The main metabolite is 7-hydroxymethotrexate.
Maltese: Il-metabolit ewlieni huwa 7-hydroxymethotrexate.
English: Macrogol 400
Maltese: Macrogol 400 Glycerol
English: Cytomegalovirusinduced infections.
Maltese: Infezzjonijiet indotti miċ-ċitomegalovirus.
English: Deeside Industrial Park, Flintshire, CH5 2NS United Kingdom
Maltese: Quay Pharmaceuticals Limited Quay House, 28 Parkway Deeside Industrial Park, Flintshire, CH5 2NS United Kingdom
English: Osteoporosis, Arthralgia, Myalgia,
Maltese: Osteoporożi, Artralġja, Mijalġja,
English: • Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcers
Maltese: • Stomatite, ulċeri tal-kavità orali u ulċeri gastrointestinali attivi magħrufa
English: Jylamvo contains ethyl parahydroxybenzoate and sodium methyl parahydroxybenzoate
Maltese: Jylamvo fih ethyl parahydroxybenzoate u sodium methyl parahydroxybenzoate
English: − insomnia
Maltese: − insomnija
English: In oncology
Maltese: Fl-onkoloġija
English: • Spontaneous abortions have been reported in 42.5% of pregnant women exposed to low-dose methotrexate treatment (less than 30 mg [15 ml]/week), compared to a reported rate of 22.5% in disease-matched patients treated with drugs other than methotrexate.
Maltese: • Aborti spontaneji ġew rapportati fi 42.5% ta' nisa tqal esposti għal doża baxxa ta' trattament b'methotrexate (inqas minn 30 mg [15 ml]/ġimgħa), meta mqabbla ma' rata rapportata ta' 22.5% f'pazjenti mqabbla mal-marda trattati b'mediċini li mhumiex methotrexate.
English: Interstitial alveolitis/ pneumonia (can be fatal)
Maltese: Alveolite interstizjali/ pulmonite (tista' tkun fatali)
English: Pulmonary alveolar haemorrhage3
Maltese: Emorraġija alveolari pulmonari3
English: • Severe renal impairment (creatinine clearance less than 30 ml/min, see section 4.2)
Maltese: • Indeboliment sever tal-kliewi (tneħħija tal-kreatinina inqas minn 30 ml/min ara sezzjoni 4.2)
English: Ethyl parahydroxybenzoate (E214) Sodium methyl parahydroxybenzoate (E219) Citric acid monohydrate
Maltese: Ethyl parahydroxybenzoate (E214) Sodium methyl parahydroxybenzoate (E219) Citric acid monohydrate Tri-sodium citrate
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, antimetabolites, folic acid analogues, ATC code: L01BA01
Maltese: Aġenti antineoplastiċi u immunomodulatorji, antimetaboliti, analogi ta' aċidu foliku, Kodiċi ATC:
English: The recommended dose is 10-15 mg (5-7.5 ml)/m² body surface area (BSA)/week.
Maltese: Id-doża rakkomandata hija 10-15 mg (5-7.5 ml)/m² erja tas-superfiċje tal-ġisem (body surface area:
English: Salicylates, phenylbutazone, diphenylhydantoin (= phenytoin), barbiturates, tranquillisers, oral contraceptives, tetracyclines, amidopyrine derivatives, sulphonamides, thiazide diuretics, oral hypoglycaemics, doxorubicin and p-aminobenzoic acid displace methotrexate from serum albumin binding and thus increase bioavailability and hence toxicity (indirect dose increase).
Maltese: Salicylates, phenylbutazone, diphenylhydantoin (= phenytoin), barbiturati, kalmanti, kontraċettivi orali, tetraċiklini, derivattivi ta' amidopyrine, sulfonamidi, dijuretiċi thiazide, ipoglikemiċi orali, doxorubicin u l-aċidu p-aminobenzoic iċaqalqu methotrexate mill-għaqid tal-albumina tas-seru u għalhekk tiżdied il-bijodisponibilità u b'hekk it-tossiċità (żieda fid-doża indiretta).
English: Testing of serum liver enzymes Transient increases in transaminases to twice or three times normal occur in 13-20% of patients.
Maltese: Ittestjar ta' enzimi tal-fwied tas-seru Żidiet temporanji fi transaminases għal darbtejn jew tliet darbiet iżjed min-normal iseħħu fi 13-20 % tal-pazjenti.
English: Important warning about the dose of Jylamvo (methotrexate):
Maltese: Twissijiet u prekawzjonijiet Twissija importanti dwar id-doża ta' Jylamvo (methotrexate):
English: • Management of overdose (including the use of calcium folinate and dose interruption).
Maltese: • Ġestjoni ta' doża eċċessiva (inkluż l-użu ta' calcium folate u interruzzjoni fid-doża).
English: Oral solution 60 ml bottle Bottle adaptor 10 ml dosing syringe
Maltese: Soluzzjoni orali Flixkun ta' 60 ml Adapter tal-flixkun siringa tad-dożaġġ ta' 10 ml
English: Fertility
Maltese: Il-fertilità
English: Methotrexate causes embryotoxicity, abortion and foetal malformations in humans.
Maltese: Methotrexate jikkawża embrijotossiċità, abort u malformazzjonijiet fetali fil-bniedem.