FrancophonIA/ELRC3.0 huggingface dataset:
English: The antidote in the event of an overdose is calcium folinate.
Maltese: L-antidotu fil-każ ta' doża eċċessiva huwa calcium folinate.
English: Most frequently (very common) observed adverse reactions of methotrexate include gastrointestinal disorders (e.g. stomatitis, dyspepsia, abdominal pain, nausea, loss of appetite) and abnormal liver function tests (e.g. increased alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), bilirubin, alkaline phosphatase).
Maltese: Ir-reazzjonijiet avversi ta' methotrexate osservati bl-aktar mod frekwenti (komuni ħafna) jinkludu disturbi gastrointestinali (eż stomatite, dispepsja, uġigħ addominali, dardir, telf ta' aptit) u testijiet tal funzjoni tal-fwied mhux normali (eż. żieda fl-alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), bilirubin, alkaline phosphatase).
English: Ulceration and bleeding of gastrointestinal tract
Maltese: Ulċerazzjoni u fsada tal-passaġġ gastrointestinali
English: Each pack contains one bottle, an LDPE bottle adaptor and a 10 ml white polypropylene dosing syringe (with major graduations at every 1 ml and minor graduations at every 0.25 ml).
Maltese: Kull pakkett fih flixkun wieħed, adapter tal-flixkun LDPE u siringa tad-dożaġġ tal-polypropylene bajda ta' 10 ml (bi gradwazzjonijiet maġġuri kull 1 ml u gradwazzjoni minuri kull 0.25 ml).
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: 60 ml
Maltese: Soluzzjoni orali. 60 ml
English: Combination therapy with methotrexate and leflunomide may increase the risk for pancytopenia.
Maltese: It-terapija kombinata ta' methotrexate flimkien ma' leflunomide tista' żżid ir-riskju ta' panċitopenja.
English: This medicinal product contains sodium methyl parahydroxybenzoate (E219) and ethyl parahydroxybenzoate (E214).
Maltese: Dan il-prodott mediċinali fih sodium methyl parahydroxybenzoate (E219) u ethyl parahydroxybenzoate (E214).
English: • Hepatic impairment (bilirubin levels are >5 mg/dl [85.5 µmol/l], see section 4.2)
Maltese: • Indeboliment tal-fwied (il-livelli ta' bilirubin huma >5 mg/dl [85.
English: The usual dose is 10 mg-25 mg (5 ml12.5 ml) taken once weekly.
Maltese: Id-doża tas-soltu hi ta' 10 mg-25 mg (5 ml-12.5 ml) li tittieħed darba fil-ġimgħa.
English: Osteonecrosis of jaw (secondary to lymphoprolifer -ative disorders)
Maltese: Osteonekro liżi tax xedaq (sekondarja għal disturbi limfoprolif erattivi)
English: Dysarthria, Unusual cranial sensations, Tinnitus
Maltese: Sensazzjonijiet kranjali mhux tas-soltu, Tinnitus
English: Malignant lymphomas
Maltese: Linfomi malinni
English: Opportunistic infections can occur during treatment with methotrexate, including Pneumocystis jiroveci pneumonia, which can also have a fatal outcome.
Maltese: Waqt il-kura b'methotrexate jistgħu jseħħu infezzjonijiet opportunistiċi, inkluż pulmonite b'pneumocystis jiroveci, li jista' jkollha wkoll riżultat fatali.
English: Methotrexate is a powerful human teratogen, with an increased risk of spontaneous abortions, intrauterine growth restriction and congenital malformations in case of exposure during pregnancy.
Maltese: Methotrexate huwa teratoġen qawwi uman, b'riskju ogħla ta' aborti spontaneji, restrizzjoni fl-iżvilupp ġol-utru u malformazzjonijiet konġenitali f'każ ta' esponiment waqt it-tqala.
English: Cerebral oedema, Acute aseptic meningitis with meningism (paralysis, vomiting), Lethargy,
Maltese: Edema ċerebrali, Meninġite assetika akuta b'meninġiżmu (paraliżi, rimettar), Letarġija,
English: Jylamvo 2 mg/ml oral solution methotrexate
Maltese: Jylamvo 2 mg/ml soluzzjoni orali methotrexate
English: • Immunodeficiency
Maltese: • Immunodefiċjenza
English: When administered in low doses (7.5 mg/m2 to 80 mg/m2 body surface area), the mean bioavailability of methotrexate is approximately 70%, but considerable inter- and intra-individual variations are possible (25-100%).
Maltese: Meta jingħata f'dożi baxxi (7.5 mg/m2 to 80 mg/m2 l-erja tas-superfiċje tal-ġisem), il-bijodisponibbiltà medja ta' methotrexate hija madwar 70 %, iżda huma possibbli varjazzjonijiet inter- u intra-individwali konsiderevoli (25-100%).
English: It is recommended that a test dose of 2.5-5 mg (1.25-2.5 ml) be administered one week prior to initiation of therapy, in order to detect early occurring adverse reactions.
Maltese: Huwa rrakkomandat li tingħata doża bħala test ta' 2.5-5 mg (1.25-2.5 ml) ġimgħa qabel ma tinbeda tterapija, sabiex jiġu rilevati reazzjonijiet avversi li jseħħu kmieni.Jekk ġimgħa wara, it-testijiet fil laboratorju xierqa jkunu normali, tista' tinbeda l-kura.
English: − infections
Maltese: − infezzjonijiet
English: Pharmacokinetic interactions between methotrexate, anticonvulsants (reduced serum methotrexate levels) and 5-fluoruracil (increased half-life of 5-fluoruracil) must be borne in mind.
Maltese: (livelli mnaqqsa ta' methotrexate fis-seru) u 5-fluoruracil (żieda tan-nofs ħajja ta' 5-fluoruracil).
English: Excessive consumption of caffeine- or theophylline-containing beverages (coffee, caffeinated beverages, black tea) should be avoided during methotrexate therapy as the effect of methotrexate may be reduced by the possible interaction between methotrexate and methylxanthines at the adenosine receptors.
Maltese: Il-konsum eċċessiv ta' kafeina jew xorb li fih it-teofillina (kafè, xorb bil-kafeina, te iswed) għandu jiġi evitat waqt it-terapija b'methotrexate peress li l-effett ta' methotrexate jista' jitnaqqas mill-interazzjoni possibbli bejn methotrexate u methylxanthines fir-riċetturi ta' adenosine.
English: Administration of additional haematotoxic medicinal products (e.g. metamizole) increases the likelihood of severe haematotoxic adverse reactions to methotrexate.
Maltese: L-għoti ta' prodotti mediċinali tossiċi għad-demm addizzjonali (eż. metamizole) iżid il-probabbiltà ta' reazzjonijiet tossiċi għad-demm severi għal methotrexate.
English: Symptoms of overdose The symptoms following oral overdose predominantly affect the haematopoietic and gastrointestinal systems.
Maltese: Is-sintomi wara doża eċċessiva orali jaffettwaw b'mod predominanti s-sistemi ematopojetiċi u gastrointestinali.
English: Concomitant therapy with medicinal products that can cause folic acid deficiency (e.g. sulphonamides, trimethoprim/sulphamethoxazole) can result in increased methotrexate toxicity.
Maltese: It-terapija konkomitanti bi prodotti mediċinali li jistgħu jikkawżaw defiċjenza ta' aċidu foliku (eż. sulfonamidi, trimethoprim/sulphamethoxazole) tista' tirriżulta f'tossiċità ta' methotrexate miżjuda.
English: (See renal function monitoring)
Maltese: (ara l-monitoraġġ tal-funzjoni tal-kliewi)
English: Teratogenic effects have been observed in four species (rats, mice, rabbits, cats).
Maltese: L-effetti teratoġeniċi ġew osservati f'erba' speċi (firien, ġrieden, fniek, qtates).
English: Limited clinical evidence does not indicate an increased risk of malformations or miscarriage following paternal exposure to low-dose methotrexate (less than 30 mg [15 ml]/week).
Maltese: Evidenza ristretta ma tindikax riskju ogħla ta' malformazzjonijiet jew korrimenti fit-tqala wara esponiment paternali għal doża baxxa ta' methotrexate (inqas minn 30 mg [15 ml]/ġimgħa).
English: The other ingredients are: macrogol 400, glycerol, orange flavour, sucralose, ethyl parahydroxybenzoate (E214), sodium methyl parahydroxybenzoate (E219), citric acid, tri-sodium citrate, purified water.
Maltese: L-ingredjenti l-oħra huma: macrogol 400, gliċerol, togħma ta' larinġ, sukralożju, ethyl parahydroxybenzoate (E214), sodium methyl parahydroxybenzoate (E219), aċidu ċitriku, ċitrat tat tri-sodju, ilma ppurifikat.
English: There are reports of deaths from sepsis, septic shock, renal failure and aplastic anaemia.
Maltese: Hemm rapporti ta' mwiet minn sepsis, xokk settiku, insuffiċjenza tal-kliewi u anemija aplastika.
English: Severe visual disturbances
Maltese: − disturbi severi fil-vista
English: Erythema, Exanthema,
Maltese: Eritema, Exanthema, Prurite
English: Most serious adverse reactions of methotrexate include bone marrow suppression, pulmonary toxicity, hepatotoxicity, renal toxicity, neurotoxicity, thromboembolic events, anaphylactic shock and StevensJohnson syndrome.
Maltese: Ir- reazzjonijiet avversi l-aktar serji ta' methotrexate jinkludu soppressjoni tal-mudullun, tossiċità pulmonari, epatotossiċità, tossiċità tal-kliewi, newrotossiċità, avvenimenti tromboemboliċi, xokk anafilattiku u s-sindromu ta' Stevens-Johnson.
English: Symptoms include leucocytopenia, thrombocytopenia, anaemia, pancytopenia, neutropenia, myelosuppression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration and bleeding.
Maltese: Is-sintomi jinkludu lewkoċitopenija, tromboċitopenja, anemija, panċitopenija, newtropenja, majelusoppressjoni, mukożite, stomatite, ulċerazzjoni orali, dardir, rimettar, ulċerazzjoni gastrointestinali u fsada.
English: The dose normalized AUC of the metabolite 7-hydroxymethotrexate was not dependent on age.
Maltese: L-AUC normalizzata tal-doża tal-metabolit 7-hydroxymethotrexate ma kinitx dipendenti fuq l-età.
English: Urticaria
Maltese: Diżurja
English: − viral, fungal or bacterial systemic infections,
Maltese: − infezzjonijiet virali, fungali jew sistemiċi batterjali
English: See also section “Pregnancy, breast-feeding and fertility”.
Maltese: Ara wkoll is-sezzjoni “Tqala, treddigħ u fertilità”.
English: • Severe, acute or chronic infections such as tuberculosis and HIV
Maltese: • Infezzjonijiet severi, akuti jew kroniċi bħat-tuberkulożi u l-HIV
English: If creatinine clearance is less than 30 ml/min, treatment with methotrexate should not be given (see sections 4.2 and 4.3).
Maltese: Jekk l-eliminazzjoni tal-kreatinina tkun inqas minn 30 ml/min, m'għandhiex tingħata lkura b'methotrexate (ara s-sezzjonijiet 4.2 u 4.3).
English: Calcium folinate is the specific antidote for neutralising the adverse toxic effects of methotrexate.
Maltese: Il-calcium folinate huwa l-antidotu speċifiċi għan-newtralizzazzjoni tal-effetti tossiċi avversi ta' methotrexate.
English: The recommended initial dose is 7.5 mg (3.75 ml) methotrexate once weekly.
Maltese: Id-doża inizjali rakkomandata hija 7.5 mg (3.75 ml) methotrexate darba fil-ġimgħa.
English: − bleeding from the lungs*
Maltese: − fsada fil-pulmuni*
English: In one case in which methotrexate was combined with pantoprazole, renal elimination of the metabolite 7-hydroxymethotrexate was inhibited and myalgia and shivering occurred.
Maltese: F'każ wieħed, fejn methotrexate ġie kkombinat ma' pantoprazole, leliminazzjoni mill-kliewi tal-metabolit 7-hydroxymethotrexate ġiet inibita u seħħew mijalġja u tertir.
English: Not known (frequency cannot be estimated from the available data)
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-data disponibbli).
English: Jylamvo 2 mg/ml oral solution
Maltese: Jylamvo 2 mg/ml soluzzjoni orali
English: • Information on treatment with Jylamvo, administration and posology.
Maltese: • Informazzjoni dwar kura b'Jylamvo, l-għoti u l-pożoloġija.
English: • Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate.
Maltese: • Għamliet ta' forom ta' poliartrite ta' artrite idjopatika ġovanili (severe juvenile idiopathic arthritis, JIA) attiva, severa fl-adolexxenti u fit-tfal ta' 3 snin u iżjed meta r-rispons għal mediċini antiinfjammatorji mhux sterojdi (non-steroidal anti-inflammatory drugs, NSAIDS) ma jkunx adegwat.
English: − acute hepatitis (inflammation of the liver)
Maltese: − epatite akuta (infjammazzjoni tal-fwied)
English: Put on disposable gloves before handling.
Maltese: M'għandekx tieħu aktar mid-doża preskritta.
English: Jylamvo with food, drink and alcohol
Maltese: Jylamvo ma' ikel, xorb u alkoħol
English: − dizziness, confusion, seizures
Maltese: − sturdament, konfużjoni, aċċessjonijiet
English: - Renal function should be monitored by renal function tests and urinalyses.
Maltese: - Il-funzjoni tal-kliewi għandha tiġi mmonitorjata permezz ta' testijiet tal-funzjoni tal-kliewi u analiżi tal-awrina (urinalyses).
English: Common accepted single doses lie in the range of 20-40 mg (10-20 ml)/m² body surface area.
Maltese: Dożi b'waħdiet komuni aċċettati jaqgħu fil-firxa ta' 20-40 mg (10-20 ml)/m² erja tas-superfiċje talġisem.
English: There is a risk of excessive immunosuppression with risk of lymphoproliferation when the combination is used.
Maltese: Meta tintuża l-kombinazzjoni hemm riskju ta' immunosoppressjoni eċċessiva b'riskju ta' limfoproliferazzjoni.
English: Dose in acute lymphoblastic leukaemia (ALL)
Maltese: Id-doża f'lewkimja limfoblastika akuta (acute lymphoblastic leukaemia, ALL)
English: Combined administration of mercaptopurine and methotrexate can increase the bioavailability of mercaptopurine, possibly as a result of inhibition of the metabolism of mercaptopurine.
Maltese: L-għoti kkombinat ta' mercaptopurine u methotrexate jista' jżid il-bijodisponibbiltà ta' mercaptopurine, possibbilment bħala riżultat ta' inibizzjoni tal-metaboliżmu ta' mercaptopurine.
English: In the event of (prior) treatment with medicinal products that can have adverse reactions on bone marrow (e.g. sulphonamides, trimethoprim/sulphamethoxazole, chloramphenicol, pyrimethamine), the possibility of haematopoietic disorders must be considered.
Maltese: Fil-każ ta' kura (minn qabel) bi prodotti mediċinali li jista' jkollhom reazzjonijiet avversi fuq ilmudullun (eż. sulfonamidi, trimethoprim/sulphamethoxazole, chloramphenicol, pyrimethamine) għandha titqies il-possibbiltà ta' disturbi ematopojetiċi.
English: − blood test showing raised liver enzymes.
Maltese: − test tad-demm li juri żieda fl-enzimi tal-fwied.
English: One ml of solution contains 2 mg methotrexate.
Maltese: Kull ml tas-soluzzjoni fih 2 mg methotrexate.
English: Hepatic impairment
Maltese: Vaskulite allerġika
English: In animal studies, methotrexate has shown reproductive toxicity, especially during the first trimester (see section 5.3).
Maltese: Fi studji fuq lannimali, methotrexate wera tossiċità riproduttiva, speċjalment waqt l-ewwel trimestru (ara sezzjoni 5.3).
English: Pleural effusions or ascites
Maltese: Epatite akuta u epatotossiċità
English: Pain,
Maltese: Uġigħ,
English: Important warning about the dosage of Jylamvo (methotrexate)
Maltese: Twissija importanti dwar id-dożaġġ ta' Jylamvo (methotrexate)
English: In humans, methotrexate has been reported to cause oligospermia, menstrual dysfunction and amenorrhoea.
Maltese: methotrexate ġie rapportat li jikkaġuna oligospermja, diżfunzjoni menstruwali u amenorrea.
English: The consumption of alcohol should be avoided during treatment with methotrexate (see section 4.4).
Maltese: Il-konsum tal-alkoħol għandu jiġi evitat waqt il-kura b'methotrexate (ara ssezzjoni 4.4).
English: Methotrexate is contraindicated during pregnancy in non-oncological indications (see section 4.3).
Maltese: Methotrexate huwa kontraindikat waqt it-tqala f'indikazzjonijiet mhux onkoloġiċi (ara sezzjoni 4.3).
English: Telangiectasis, Hidradenitis
Maltese: Paronikja akuta, Furunculosis, Telangiectasis, Hidradenitis
English: • Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients.
Maltese: • Psorjasi diżabilitanti, refrattarja tal-kura severa li ma tirrispondix b'mod xieraq għal forom oħra ta' kura bħal fototerapija, terapija ta' radjazzjoni ta' psoralen u ultravjola A (psoralen and ultraviolet A radiation , PUVA), u retinojdi, u artrite psorjatika severa f'pazjenti adulti.
English: It is important to determine any increase in active substance levels within 48 hours of therapy, otherwise irreversible methotrexate toxicity may occur.
Maltese: Huwa importanti li tiġi ddeterminata kwalunkwe żieda fil-livelli tas-sustanza attiva fi żmien 48 siegħa ta' terapija, inkella tista' sseħħ tossiċità b'methotrexate irriversibbli.
English: If the oral route is ineffective, a change to a parenteral dosage form is indicated.
Maltese: Jekk ir-rotta orali tkun ineffettiva, tiġi indikata bidla għal forma tad-dożaġġ parenterali.
English: Hepatitis and liver failure4
Maltese: Epatite u insuffiċjen za talfwied4
English: Fever,
Maltese: Infertilità,
English: Regular alcohol consumption and administration of additional hepatotoxic medicinal products increase the likelihood of hepatotoxic adverse reactions to methotrexate.
Maltese: Il-konsum regolari tal-alkoħol u l-għoti ta' prodotti mediċinali epatotossiċi addizzjonali jżidu l-probabbiltà ta' reazzjonijiet avversi epatotossiċi għal methotrexate.
English: Herpes zoster
Maltese: Ħerpes żoster Sepsi
English: − haemorrhages
Maltese: − emorraġiji
English: Posology Rheumatological and dermatological diseases
Maltese: Pożoloġija Mard rewmatoloġiku u dermatoloġiku
English: − inflammation and ulcers of the vagina.
Maltese: − infjammazzjoni u ulċeri tal-vaġina
English: Vitamin preparations or other products containing folic acid, folinic acid or their derivatives may decrease the effectiveness of methotrexate (see sections 4.2 and 4.5).
Maltese: Il-preparazzjonijiet tal-vitamini jew prodotti oħrajn li fihom aċidu foliku, aċidu foliniku jew derivattivi tagħhom jistgħu jnaqqsu l-effettività ta' methotrexate (ara s-sezzjonijiet 4.2 u 4.5).
English: • Recommendation to monitor patients for signs and symptoms of overdose (these predominantly affect the haematopoietic and gastrointestinal systems)
Maltese: • Rakkomandazzjoni biex il-pazjenti jiġu mmonitorjati għal sinjali u sintomi ta' doża eċċessiva (b'mod predominanti, dawn jaffettwaw sistemi ematopojetiċi u gastrointestinali)
English: It acts by competitive inhibition of the enzyme dihydrofolate reductase and thus inhibits DNA synthesis.
Maltese: Dan jaġixxi bl-inibizzjoni kompetittiva tal-enżima dihydrofolate reductase u b'hekk jinibixxi s-sinteżi tad-DNA.
English: Encephalopathy/leukoencephalopathy
Maltese: Enċefalopatija/lewkoenċefalopatija
English: − worsening of psoriasis during treatment with UV therapy
Maltese: − aggravar tal-psorjasi waqt il-kura b'terapija tal-UV
English: Opportunistic infections (sometimes fatal)
Maltese: Infezzjonijiet opportunistiċi
English: In addition, pulmonary alveolar haemorrhage has been reported with methotrexate used in rheumatologic and related indications.
Maltese: Barra minn hekk, ġiet irrapportata emorraġija alveolari pulmonari b'methotrexate użat f'indikazzjonijiet rewmatoloġiċi u dawk relatati.
English: Increase in liver-related enzymes (ALAT [GPT], ASAT [GOT], alkaline phosphatase and bilirubin)
Maltese: [GOT], alkaline phosphatase u bilirubina)
English: Ethyl parahydroxybenzoate (E214) and sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).
Maltese: Ethyl parahydroxybenzoate (E214) u sodium methyl parahydroxybenzoate (E219) jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jittardjaw).
English: If a patient develops pulmonary symptoms, the possibility of Pneumocystis jiroveci pneumonia should be considered.
Maltese: Jekk pazjent jiżviluppa sintomi pulmonari, għandha titqies il-possibbiltà ta' pulmonite b'pneumocystis jiroveci.
English: Because of the possibility of severe or even fatal toxic reactions, patients should be extensively informed by the treating doctor of the risks involved (including early signs and symptoms of toxicity) and the recommended safety measures.
Maltese: Minħabba l-possibbiltà ta' reazzjonijiet tossiċi severi jew saħansitra fatali, il-pazjenti għandhom jiġu infurmati b'mod estensiv mit-tabib kuranti bir-riskji involuti (inklużi sinjali u sintomi bikrija ta' tossiċità) u l-miżuri ta' sigurtà rakkomandati.
English: Oral antibiotics such as tetracyclines, chloramphenicol and non-absorbable broad-spectrum antibiotics may reduce intestinal absorption of methotrexate or interfere with the enterohepatic circulation by inhibiting intestinal flora or suppressing bacterial metabolism.
Maltese: L-antibijotiċi orali bħal tetraċiklini, kloramfenikol u antibijotiċi bi spettru wiesa' mhux assorbibbli jistgħu jnaqqsu l-assorbiment intestinali ta' methotrexate jew jinterferixxu maċ-ċirkolazzjoni enteroepatika billi jinibixxu l-flora intestinali jew irażżnu l-metaboliżmu batterjali.
English: Particular caution is required in patients with impaired pulmonary function.
Maltese: Hija meħtieġa attenzjoni partikolari f'pazjenti b'funzjoni pulmonari indebolita.
English: Dosage in adults with severe forms of psoriasis and adult patients with psoriatic arthritis
Maltese: Id-dożaġġ f'adulti b'forom severi ta' psorjasi u f'pazjenti adulti b'artrite psorjatika.
English: 75 ml amber type III glass bottle with tamper evident child-resistant closure (polypropylene with expanded polyethylene liner) containing 60 ml of oral solution.
Maltese: (polypropylene b'rita ta' expanded polyethylene) li fih 60 ml ta' soluzzjoni orali.
English: Women of childbearing potential/Contraception in females Women must not get pregnant during methotrexate therapy, and effective contraception must be used during treatment with methotrexate and at least 6 months thereafter (see section 4.4).
Maltese: Nisa li jistgħu jinqabdu tqal/Kontraċezzjoni fin-nisa In-nisa m'għandhomx jinqabdu tqal waqt it-terapija b'methotrexate, u kontraċezzjoni effettiva għandha tintuża waqt il-kura b'methotrexate u mill-inqas 6 xhur wara dan (ara s-sezzjoni 4.4).
English: • Alcohol abuse
Maltese: • Abbuż mill-alkoħol
English: In therapy-refractory cases the weekly dosage may be increased to 20 mg (10 ml)/m² BSA/week.
Maltese: F'każijiet refrattarji tat-terapija, id-dożaġġ fil-ġimgħa jista' jiżdied għal 20 mg (10 ml)/m²
English: Other frequently (common) occurring adverse reactions are leukopenia, anaemia, thrombopenia, headache, tiredness, drowsiness, pneumonia, interstitial alveolitis/pneumonitis often associated with eosinophilia, oral ulcers, diarrhoea, exanthema, erythema and pruritus.
Maltese: Reazzjonijiet avversi oħrajn li jseħħu b'mod frekwenti (komuni) huma lewkopenja, anemija, trombopenja, uġigħ ta' ras, għeja, ħedla, pulmonite, alveolite/pulmonite interstizzjali spiss assoċjata ma' eosinofilja, ulċeri orali, dijarea, eksantema, eritema u ħakk.
English: − severe fatigue.
Maltese: − għeja severa.
English: − pathological change of the white matter of the brain (leukoencephalopathy)
Maltese: − bidla patoloġika tal-materja bajda fil-moħħ (lewkoenċefalopatija)
English: Hepatobiliary disorders
Maltese: − antibijotiċi
English: During methotrexate therapy, concurrent vaccination with live vaccines should be avoided (see sections 4.3 and 4.4).
Maltese: Waqt it-terapija b'methotrexate, it-tilqim konkorrenti b'vaċċini ħajjin għandu jiġi evitat (ara s-sezzjonijiet 4.3 u 4.4).
English: - cancer treatments ( such as doxorubicin and procarbazine during high-dose methotrexate therapy)
Maltese: − kuri għall-kanċer (bħal doxorubicin u procarbazine matul terapija ta' dożi għoljin ta'
English: Depending on the individual activity of the disease and tolerability by the patient, the dose may be increased gradually by 2.5 mg (1.25 ml) per week.
Maltese: Skont l-attività individwali tal-marda u t-tollerabilità mill-pazjent, id-doża tista' tiżdied gradwalment b' 2.5 mg (1.25 ml) fil-ġimgħa.
English: Dosage for psoriasis and psoriatic arthritis: The usual initial dose is 7.5 mg (3.75 ml), once a week.
Maltese: Id-doża inizjali tas-soltu hija ta' 7.5 mg (3.75 ml), darba fil-ġimgħa.
English: Mucositis generally appears about 3 to 7 days after methotrexate application, leucopenia and thrombocytopenia follow a few days later.
Maltese: Il-mukożite ġeneralment tidher madwar 3 sa 7 ijiem wara lapplikazzjoni ta' methotrexate, il-lewkopenja u t-tromboċitopenja jsegwu ftit jiem wara.
English: Response to treatment can generally be expected after approximately 4-8 weeks.
Maltese: Ir-rispons għall-kura jista' jkun mistenni wara bejn wieħed u ieħor 4-8 ġimgħat.