FrancophonIA/ELRC3.0 huggingface dataset:
English: When administered in low doses (7.5 mg/m to 80 mg/m
Maltese: Meta jingħata f'dożi baxxi (7.5 mg/m għal 80 mg/m
English: You may also have a chest X-ray.
Maltese: Jista' wkoll ikollok X-ray tas-sider.
English: The pre-filled syringes contain 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml or 1 ml solution for injection.
Maltese: Is-siringi mimlija għal-lest fihom 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml jew 1 ml soluzzjoni għallinjezzjoni.
English: Regular alcohol consumption and administration of additional hepatotoxic medicinal products increase the probability of hepatotoxic effects of methotrexate.
Maltese: Konsum regolari t'alkoħol u l-għoti ta' prodotti mediċinali epatotossiċi addizzjonali jżidu l-probabilità ta' effetti epatotossiċi ta' methotrexate.
English: Instructions on injecting yourself with Nordimet 1) Wash your hands thoroughly with soap and water.
Maltese: Istruzzjonijiet dwar kif tinjetta Nordimet fuqek innifsek 1) Aħsel idejk sew b'ilma u sapun.
English: Most serious adverse reactions of methotrexate include bone marrow suppression, pulmonary toxicity, hepatotoxicity, renal toxicity, neurotoxicity, thromboembolic events, anaphylactic shock and Stevens-Johnson syndrome.
Maltese: L-aktar reazzjonijiet avversi serji ta' methotrexate jinkludu t-trażżin tal-mudullun, tossiċità pulmonari, epatossiċità, tossiċità tal-kliewi, newrotossiċità, każijiet tromboemboliċi, xokk anafilattiku u s-sindrome ta' Stevens-Johnson.
English: Rare: Renal failure, oliguria, anuria, electrolyte disturbances.
Maltese: Falliment tal-kliewi, oligurja, anurja, disturbi fl-elettroliti.
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 spontanji, restrizzjoni fl-iżvilupp fl-utru u malformazzjonijiet konġenitali f'każ ta' esponiment waqt it-tqala.
English: Uncommon: Pharyngitis.
Maltese: Mhux komuni: Sturdament.
English: Uncommon: Inflammation and ulceration of the vagina.
Maltese: Mhux komuni: Infjammazzjoni u ulċerazzjoni tal-vaġina.
English: In combination with pantoprazole, inhibited renal elimination of the 7-hydroxymethotrexate metabolite, with myalgia and shivering, was reported in one case.
Maltese: F'kombinazzjoni ma' pantoprazole, l-eliminazzjoni impeduta mill-kliewi tal-metabolit 7-hydroxymethotrexate, b'mijalġja u tertir, ġiet rapportata f'każ wieħed.
English: Encephalopathy / Leukoencephalopathy have been reported in oncologic patients receiving methotrexate therapy and cannot be excluded for methotrexate therapy in non-oncologic indications.
Maltese: Enċefalopatija / Lewkoenċefalopatija ġiet rapportata f'pazjenti onkoloġiċi li jirċievu terapija b'methotrexate u ma jistgħux jiġu esklużi għal terapija b'methotrexate f'indikazzjonijiet mhux onkoloġiċi.
English: After oral application, methotrexate is absorbed from the gastrointestinal tract.
Maltese: Wara l-applikazzjoni orali, methotrexate jiġi assorbit mill-passaġġ gastrointestinali.
English: Methotrexate causes embryotoxicity, abortion and foetal defects in humans.
Maltese: Methotrexate jikkaġuna embrijotossiċità, abort u difetti fetali fil-bniedem.
English: Alcohol consumption must be avoided during treatment with methotrexate.
Maltese: Il-konsum t'alkoħol għandu jiġi evitat waqt it-trattament b'methotrexate.
English: Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (għall-aġġustament ta' pH)
English: Musculoskeletal and connective tissue disorders Uncommon: Arthralgia, myalgia, osteoporosis.
Maltese: Mhux komuni: Artralġja, mijalġja, osteoporożi.
English: Rare: Increased pigmentation, acne, petechiae, ecchymosis, allergic vasculitis.
Maltese: Żieda fil-pigmentazzjoni, akne, petekije, eċċimosi, vaskulite allerġika.
English: Nordimet 22.5 mg solution for injection methotrexate
Maltese: Nordimet 22.5 mg soluzzjoni għall-injezzjoni methotrexate
English: In patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis or psoriasis vulgaris, administration of folic or folinic acid may reduce methotrexate toxicity (gastrointestinal symptoms, inflammation of oral mucosa, hair loss and increase of liver enzymes) (see section 4.5).
Maltese: F'pazjenti b'artrite rewmatika, artrite idjopatika ġovanili poliartikolari, artrite psorjatika jew psorjati vulgaris, l-għoti ta' folic acid jew folinic acid jista' jnaqqas it-tossiċità ta' methotrexate (sintomi gastrointestinali, infjammazzjoni ta' mukosa orali, telf ta' xagħar u żieda fl-enzimi tal-fwied) (ara sezzjoni 4.5).
English: Not known: Encephalopathy/ Leukoencephalopathy.
Maltese: Mhux magħruf: Enċefalopatija / Lewkoenċefalopatija.
English: Important warning about the dosage of Nordimet
Maltese: Twissija importanti dwar id-doża ta' Nordimet
English: Uncommon: Cirrhosis, fibrosis and fatty degeneration of the liver, decrease in serum albumin.
Maltese: Mhux komuni: Ċirrosi, fibrożi u deġenerazzjoni tal-grass tal-fwied, tnaqqis tal-albumina fis-serum.
English: (a medicine that besides arthritis and psoriasis is also used to treat ulcerative colitis), aspirin,
Maltese: (mediċina li minbarra l-artrite u l-psorjasi tintuża wkoll għal trattament ta' kolite ulċerattiva),
English: Very rare: Haematemesis, haematorrhea, toxic megacolon.
Maltese: Rari ħafna: Ematemesi, ematorrea, megakolon tossiku.
English: Only mild local skin reactions were observed with Nordimet and these decreased during therapy.
Maltese: Reazzjonijiet tal-ġilda ħfief u lokali biss ġew osservati b'Nordimet u dawn naqqsu waqt it-terapija.
English: Nordimet contains the active substance methotrexate which works by: - reducing inflammation or swelling, and - reducing the activity of the immune system (the body's own defense mechanism).
Maltese: Nordimet fih is-sustanza attiva methotrexate li jaħdem billi: - inaqqas l-infjammazzjoni jew in-nefħa, u - inaqqas l-attività tas-sistema immuni (il-mekkaniżmu ta' difiża tal-ġisem stess).
English: phenylbutazone, or amidopyrine - alcohol (drinking alcohol should be avoided while you are taking Nordimet) - azathioprine (used to prevent rejection after an organ transplant) - retinoids (used to treat psoriasis and other skin disorders) - anticonvulsant medicines (used to prevent fits), such as phenytoin, valproate or carbamazepine - cancer treatments - barbiturates (sleeping injection) - tranquillisers - oral contraceptives - probenecid (used to treat gout) - antibiotics - pyrimethamine (which is used to prevent and treat malaria) - vitamin preparations containing folic acid - proton-pump inhibitors (medicines that reduce the production of gastric acid and that are used to treat severe heartburn or ulcers), such as omeprazole - theophylline (used to treat asthma) - any vaccination with a live vaccine (must be avoided), such as measles, mumps, influenza or yellow fever vaccines.
Maltese: aspirina, phenylbutazone, jew amidopyrine - alkoħol (li tixrob l-alkoħol għandu jiġi evitat waqt li qed tieħu Nordimet) - azathioprine (użat biex jipprevjeni r-riġetazzjoni wara trapjant ta' organu) - retinojdi (użati biex jittrattaw il-psorjasi u disturbi oħra tal-ġilda) - mediċini antikonvulsanti (użati biex jipprevjenu l-attakki pupletiċi), bħal phenytoin, valproate jew carbamazepine - trattamenti tal-kanċer - barbiturates (injezzjoni tal-irqad) - sedattivi - kontraċettivi orali - probenecid (użat biex jittratta l-gotta) - antibijotiċi - pyrimethamine (li jintuża għal prevenzjoni u t-trattament ta' malarja) - taħlitiet ta' vitamini li fihom folic acid - impedituri ta' proton-pump (mediċini li jnaqqsu l-produzzjoni ta' aċidu gastriku u li jintużaw sabiex jittrattaw l-uġigħ fl-istonku severi jew ulċeri), bħal omeprazole - theophylline (użat biex jittratta l-ażma) - kull tilqima b'vaċċin ħaj (għandu jiġi evitat), bħal vaċċini tal-ħosba, gattone, influwenza jew tad-deni l-isfar.
English: In humans, methotrexate has been reported to cause oligospermia, menstrual dysfunction and amenorrhoea.
Maltese: Fil-bniedem, methotrexate ġie rapportat li jikkaġuna oligospermja, disfunzjoni menstruwali u amenorrea.
English: Particular caution should be exercised in the presence of inactive, chronic infections (e.g. herpes zoster, tuberculosis, hepatitis B or C) due to possible activation.
Maltese: Attenzjoni partikolari għandha tiġi eżerċitata fil-preżenza ta' infezzjonijiet inattivi u kroniċi (eż. herpes zoster, tuberkolosi, epatite B jew Ċ) minħabba l-attivazzjoni possibbli.
English: Metabolism and nutrition disorders Uncommon: Precipitation of diabetes mellitus.
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni: Preċipitazzjoni ta' dijabete mellitus.
English: The most relevant adverse reaction is suppression of the haematopoietic system and gastrointestinal disorders.
Maltese: L-aktar reazzjoni avversa rilevanti hija t-taffija tas-sistema ematopojetika u disturbi gastrointestinali.
English: Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis vulgaris and psoriatic arthritis with Nordimet is a long-term treatment.
Maltese: It-trattament ta' artrite rewmatika, artrite idjopatika ġovanili, psorjasi vulgaris u artrite psorjatika b'Nordimet huwa trattament fuq terminu ta' żmien twil.
English: Excessive consumption of beverages containing caffeine or theophylline (coffee, soft drinks containing caffeine, black tea) should be avoided during methotrexate therapy since the efficacy of methotrexate may be reduced due to possible interaction between methotrexate and methylxanthines at adenosine receptors.
Maltese: Konsum eċċessiv ta' xorb li jkun fih il-kaffeina jew theophylline (kafe, bevandi mhux alkoħoliċi li jkun fihom il-kaffeina, te iswed) għandu jiġi evitat waqt it-terapija b'methotrexate peress li l-effikaċja ta' methotrexate tista' titnaqqas minħabba l-interazzjoni possibbli bejn methotrexate u methylxanthines fir-riċettaturi ta' adenosine.
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Maltese: 2. GĦAMLA KWALITATTIVA
English: Nordimet is for subcutaneous use (see section 6.6.
Maltese: Nordiment hu għal użu taħt il-ġilda (ara sezzjoni 6.6).
English: Nordimet 20 mg solution for injection methotrexate
Maltese: Nordimet 20 mg soluzzjoni għall-injezzjoni methotrexate
English: Using too much of Nordimet may be fatal.
Maltese: Jekk jintuża iżżejjed, Nordimet jista' jkun fatali.
English: Nordimet is also available in multipacks containing 12 prefilled pens in 3 cartons (4 pens and alcohol swabs per carton).
Maltese: Nordimet hu disponibbli wkoll f'pakketti multipli li fihom 12-il pinna mimlija għal-lest fi 3 kartuni (4 pinen u msieħ tal-alkoħol f'kull kartuna).
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100):
English: Nordimet is indicated for the treatment of - active rheumatoid arthritis in adult patients, - polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate, - severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, and severe psoriatic arthritis in adult patients.
Maltese: Nordimet hu indikat għat-trattament ta' - artrite rewmatika attiva f'pazjenti adulti, - għamliet ta' poliartrite ta' artritè idjopatika ġovanili attiva (JIA - juvenile idiopathic arthritis) severa, meta ir-rispons għal mediċini anti-infjammatorji mhux sterojdi (NSAIDS - nonsteroidal anti-inflammatory drugs) ma tkunx adegwata, - psorjasi diżabilitanti rikalċitranti severa li ma tirrispondix b'mod xieraq għal forom oħra ta' terapija bħal fototerapija, psoralens u ultravjola A (PUVA), u retinojdi, u artrite psorjatika severa f'pazjenti adulti.
English: Oral antibiotics such as tetracyclines, chloramphenicol and non-absorbable broad-spectrum antibiotics may reduce intestinal methotrexate absorption or interfere with the enterohepatic circulation, due to inhibition of the intestinal flora or suppression of bacterial metabolism.
Maltese: Antibijotiċi orali bħal tetracyclines, chloramphenicol u antibijotiċi ta' spettru wiesa' li ma jiġux assorbiti jistgħu jnaqqsu l-assorbiment ta' methotrexate mill-imsaren jew joħolqu tfixkil biċċirkolazzjoni enteroepatika, minħabba l-impediment tal-flora intestinali jew trażżin tal-metaboliżmu batteriku.
English: Antibiotics, like penicillin, glycopeptides, sulfonamides, ciprofloxacin and cefalotin can, in individual cases, reduce the renal clearance of methotrexate, so that increased serum concentrations of methotrexate with simultaneous haematological and gastro-intestinal toxicity may occur.
Maltese: Antibijotiċi, bħal penicillin, glycopeptides, sulfonamides, ciprofloxacin u cefalotin jistgħu, f'każijiet individwali, inaqqsu t-tneħħija mill-kliewi ta' methotrexate, u għalhekk jista' jkun hemm żieda filkonċentrazzjonijiet ta' methotrexate fis-serum b'tossiċità ematoloġika u gastrointestinali fl-istess ħin.
English: Nordimet 12.5 mg solution for injection methotrexate
Maltese: Nordimet 12.5 mg soluzzjoni għall-injezzjoni methotrexate
English: Nordimet 10 mg solution for injection methotrexate
Maltese: Nordimet 10 mg soluzzjoni għall-injezzjoni methotrexate
English: Under (pre-)treatment with substances that may have adverse effects on the bone marrow (e.g. sulphonamides, trimethoprim-sulphamethoxazole, chloramphenicol, pyrimethamine), the possibility of marked haematopoietic disorders should be considered.
Maltese: Taħt trattament (minn qabel) b'sustanzi li jista' jkollhom effetti avversi fuq il-mudullun (eż. sulphonamides, trimethoprim-sulphamethoxazole, chloramphenicol, pyrimethamine), il-possibilità ta' disturbi ematopojetiċi notevoli għandu jiġi kkonsidrat.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu)
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
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 frekwenti (komuni) li jseħħu huma lewkopenija, anemija, trombopenija, uġigħ ta' ras, għeja, ħedla, pnewmonja, alveolite interstizzjali/pnewmonite ta' spiss assoċjati ma' eosinofilja, ulċeri orali, dijarea, eksantema, eritema u ħakk.
English: You should see green plastic.
Maltese: Għandek tara plastik ħadrani.
English: Belgium
Maltese: L-Olanda
English: During methotrexate therapy, opportunistic infection can occur including pneumocystis jiroveci pneumonia, which may take a lethal course.
Maltese: Matul it-terapija b'methotrexate, jista' jkun hemm infezzjoni opportunista li tinkludi pnewmonja b'Pneumocystis jiroveci, li tista' tiżvolġi f'waħda fatali.
English: In animal experiments non-steroidal anti-inflammatory drugs (NSAIDs) including salicylic acid caused reduction of tubular methotrexate secretion and consequently increased its toxic effects.
Maltese: F'esperimenti fuq l-annimali mediċini anti-infjammatorji mhux sterojdi (NSAIDs) li jinkludi salicylic acid ikkaġunaw tnixxija ta' methotrexate tubulari u konsegwentament żdiedu l-effetti tossiċi tiegħu.
English: Nordimet 7.5 mg solution for injection methotrexate
Maltese: Nordimet 7.5 mg soluzzjoni għall-injezzjoni methotrexate
English: - Severe hepatic impairment, if serum if bilirubin is > 5 mg/dl (85.5 µmol/l) (see section 4.2).
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1. - Indeboliment sever tal-fwied, jekk il-bilirubina fis-serum tkun > 5 mg/dl (85.5 µmol/l) (ara sezzjoni 4.2).
English: Nordimet 25 mg solution for injection methotrexate
Maltese: Nordimet 25 mg soluzzjoni għall-injezzjoni methotrexate
English: Nordimet 15 mg solution for injection methotrexate
Maltese: Nordimet 15 mg soluzzjoni għall-injezzjoni methotrexate
English: Teratogenic effects have been identified in four species (rats, mice, rabbits, cats).
Maltese: Effetti teratoġeniċi ġew identifikati f'erba' speċi (firien, ġrieden, fniek u qtates).
English: Nordimet 17.5 mg solution for injection methotrexate
Maltese: Nordimet 17.5 mg soluzzjoni għall-injezzjoni methotrexate
English: Vitamin preparations or other products containing folic acid, folinic acid or their derivatives may decrease the effectiveness of methotrexate.
Maltese: Preparazzjonijiet ta' vitamini u prodotti oħra li fihom folic acid, folinic acid jew id-derivati tagħhom jistgħu jnaqqsu l-effettività ta' methotrexate.
English: Active rheumatoid arthritis is an inflammatory condition that affects the joints; - severe, active juvenile idiopathic arthritis in five or more joints (the condition is therefore called polyarthritic), in patients who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs); - a severe form of treatment resistant psoriasis (also called severe recalcitrant disabling psoriasis), in adult patients who have had an inadequate response to other treatments including phototherapy (light therapy), PUVA (ultraviolet light therapy), and retinoids (group of medicines derived from vitamin A).
Maltese: Artrite rewmatika attiva hija kondizzjoni infjammatorja li taffettwa l-ġogi; - artrite idjopatika ġovanili attiva, severa f'ħames ġogi jew aktar (għalhekk il-kondizzjoni tissejjaħ poliartrite), f'pazjenti li kellhom rispons inadegwat għal mediċini anti-infjammatorji mhux sterojdi (NSAIDs); - għamla severa ta' psorjasi reżistenti għal trattament (tissejjaħ ukoll psojasi inkapaċitanti rikalċitranti) f'pazjenti adulti li kellhom rispons mhux adegwat għal trattamenti oħra li jinkludi l-fototerapija (terapija tad-dawl), PUVA (terapija tad-dawl ultravjola), u retinojdi (grupp ta' mediċini derivati minn vitamina A).
English: Pulmonary diseases induced by methotrexate, like pneumonitis, can occur acutely at any time of therapy, they were not always completely reversible and have been reported already at all doses (inclusive low doses of 7.5 mg/week).
Maltese: Mard pulmonari indott b'methotrexate, bħal pnewmonite, jista' jseħħ b'mod akut fi kwalunkwe ħin ta' terapija, jista' ma jkunx dejjem kompletament riversibbli u diġà ġie rapportat f'kull doża (inkluż dożi baxxi ta' 7.5 mg/ġimgħa).
English: 5) Visually inspect the syringe.
Maltese: 5) Viżwalment spezzjona s-siringa.
English: Methotrexate may be genotoxic.
Maltese: Methotrexate jista'
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (jistgħu jaffettwaw sa persuna 1 f'1,000):
English: Nordimet is available in packs containing 1 or 4 pre-filled pens of 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml or 1.0 ml solution for injection with attached needle and 1 or 4 alcohol swabs and in multipacks of 4 and 6 cartons, each containing 1 pre-filled pen solution for injection with attached needle and one alcohol swab.
Maltese: Nordimet jiġi f'pakketti li fihom pinna 1 jew 4 pinen mimlija għal-lest ta' 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml jew 1.0 ml b'soluzzjoni għall-injezzjoni b'labra mwaħħla u 1 jew 4 msieħ ta' alkoħol u f'pakketti multipli ta' 4 u 6 kartuni, kull wieħed minnhom b'pinna 1 mimlija għal-lest b'soluzzjoni għall-injezzjoni b'labra mwaħħla u msieħ ta'alkoħol.
English: Methotrexate should be used with caution in patients with impaired renal function (see sections 4.3 and 4.4).
Maltese: Methotrexate għandu jintuża b'kawtela f'pazjenti b'funzjoni tal-kliewi indebolita (ara sezzjonijiet 4.3 u 4.4).
English: One ml of solution contains 25 mg of methotrexate.
Maltese: U KWANTITATTIVA Millilitru wieħed fih 25 mg ta' methotrexate.
English: Uncommon: Photosensitisation, loss of hair, increase in rheumatic nodules, skin ulcer, herpes zoster, vasculitis, herpetiform eruptions of the skin, urticaria.
Maltese: Mhux komuni: Fotosensibilizzazzjoni, nuqqas ta' xagħar, żieda fil-għenieqed rewmatiċi, ulċera talġilda, herpes zoster, vaskulite, infafet herpetiformi tal-ġilda, urtikarja.
English: In a few exceptional cases a higher dose than 25 mg might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate as toxicity will markedly increase.
Maltese: Fi ftit każijiet eċċezzjonali doża ogħla minn 25 mg tista' tkun ġustifikata klinikament, imma m'għandhiex taqbeż doża massima fil-ġimgħa ta' 30 mg methotrexate peress li t-tossiċità tiżdied notevolment.
English: Immune system disorders Rare: Allergic reactions, anaphylactic shock, hypogammaglobulinaemia.
Maltese: Disturbi fis-sistema immuni Rari: Reazzjonijiet allerġiċi, xokk anafilatiku, ipogammaglobulinemija.
English: Not known: Eosinophilia
Maltese: TWISSIJA(/IET) SPEĊJALI
English: Before initiating therapy or upon resuming therapy after a rest period Complete blood count with differential blood count and platelets, liver enzymes, bilirubin, serum albumin, chest X-ray and renal function tests must be conducted.
Maltese: Qabel tibda t-terapija jew malli tissokta t-terapija wara perjodu ta' serħan Iridu jsiru testijiet tal-għadd sħiħ tad-demm b'għadd differenzjali tad-demm u l-plejtlits, enzimi talfwied, bilirubina, albumina fis-serum, X-ray tas-sider u tal-funzjoni tal-kliewi.
English: Patients taking potentially hepatotoxic and haematoxic medicinal products during methotrexate therapy (e.g. leflunomide, azathioprine, sulphasalazine, and retinoids) should be closely monitored for possibly increased hepatotoxicity.
Maltese: Pazjenti li jieħdu prodotti mediċinali epatotossiċi u ematossiċi waqt it-terapija b'methotrexate (eż. leflunomide, azathioprine, sulphasalazine u retinojdi) għandhom jiġu monitorati mill-qrib għal epatotossiċità ogħla.
English: Nordimet is available in packs containing 1 pre-filled syringe of 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml or 1.0 ml solution for injection with attached needle with needle guard and two alcohol swabs and in multipacks of 4, 6 and 12 cartons, each containing 1 pre-filled syringe solution for injection with attached needle with needle guard and two alcohol swabs.
Maltese: Nordimet jiġi f'pakketti li fihom siringa waħda mimlija għal-lest ta' 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml jew 1.0 ml b'soluzzjoni għall-injezzjoni b'labra mwaħħla u żewġ imsieħ ta' alkoħol u f'pakketti multipli ta' 4, 6 u 12 kartuni, kull wieħed minnhom b'siringa waħda mimlija għal-lest b'soluzzjoni għall-injezzjoni b'labra mwaħħla b'tarka tal-labra u żewġ imsieħ ta' alkoħol.
English: Nordimet 22.5 mg solution for injection in pre-filled syringe EU/1/16/1124/043 - 1 pack
Maltese: Nordimet 22.5 mg soluzzjoni jew injezzjoni f'siringa mimlija għal-lest EU/1/16/1124/043 - pakkett ta' 1
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, and so is essentially “sodium-free”.
Maltese: Din il-mediċina fiha inqas minn 1 mmol ta' sodium (23 mg) f'kull doża, u għalhekk hija essenzjalment “ħielsa mis-sodju”.
English: There are reports of death due to sepsis, septic shock, renal failure and aplastic anaemia.
Maltese: Kien hemm rapporti ta' mewt minħabba sepsis, xokk settiku, falliment tal-kliewi u anemija aplastika.
English: thrombocytopenia or significant anaemia.
Maltese: tromboċitopenija jew anemija sinjifikanti.
English: Dosage in patients with psoriasis vulgaris and psoriatic arthritis It is recommended that a test dose of 5-10 mg be administered subcutaneously one week prior to initiation of therapy, in order to detect idiosyncratic adverse effects.
Maltese: Huwa rakkomandat li test dożali ta' 5-10 mg jingħata taħt il-ġilda ġimgħa qabel ma tinbeda t-terapija, sabiex jiġu rilevati effetti avversi idjosinkratiċi.
English: Incorrect administration of Nordimet can lead to severe side effects that may be fatal.
Maltese: L-għoti skorret ta' Nordimet jista' jwassal għal effetti sekondarji severi li jistgħu jkunu fatali.
English: Methotrexate can affect sperm production with the potential to cause birth defects.
Maltese: Methotrexate jista' jaffettwa l-produzzjoni tal-sperma bil-potenzjal li tikkaġuna mankamenti.
English: How to use Nordimet
Maltese: Tużax Nordiment jekk