FrancophonIA/ELRC3.0 huggingface dataset:
English: On the other hand, concomitant administration of folinic acid containing drugs or of vitamin preparations, which contain folic acid or derivatives, may impair methotrexate efficacy.
Icelandic: Hins vegar getur samtímis gjöf annarra lyfja sem innihalda fóliniksýru eða vítamínblöndur sem innihalda fólínsýru eða afleiður hennar dregið úr virkni metótrexats.
English: Common: Exanthema, erythema, pruritus.
Icelandic: Útbrotasótt, roðaþot, kláði.
English: BSA), methotrexate has a mean bioavailability of approximately 70%, although considerable inter- and intra-subject variations are possible (25-100%).
Icelandic: Þegar gefnir eru litlir skammtar (skammtar á bilinu 7,5 mg/m2 til 80 mg/m2 líkamsyfirborð) er meðaltalsaðgengið um það bil 70%, en umtalsverð frávik eru þó hugsanleg bæði milli einstaklinga og hjá sama einstaklingi (25-100%).
English: Incorrect administration of Nordimet can lead to severe side effects that may be fatal.
Icelandic: Nordimet getur leitt til alvarlegra aukaverkana sem geta verið banvænar.
English: Nordimet 25 mg solution for injection methotrexate SC
Icelandic: Nordimet 25 mg stungulyf metótrexat s.c.
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.
Icelandic: Nordimet er fáanlegt í pakkningum sem innihalda 1 eða 4 áfyllta lyfjapenna með 0,3 ml, 0,4 ml, 0,5 ml, 0,6 ml, 0,7 ml, 0,8 ml, 0,9 ml eða 1,0 ml af stungulyfi, lausn, með áfastri nál og 1 eða 4 sprittþurrkum og í fjölpakkningum sem innihalda 4 og 6 öskjur, sem hver inniheldur
English: See also section “Pregnancy, breast-feeding and fertility”.
Icelandic: „Meðganga, brjóstagjöf og frjósemi“.
English: Lymphoma/Lymphoproliferative disorders: there have been reports of individual cases of lymphoma and other lymphoproliferative disorders which subsided in a number of cases once treatment with methotrexate had been discontinued.
Icelandic: Tilkynnt hefur verið um einstaka tilvik eitilæxla og annarrar illkynja eitilfrumufjölgunar sem fækkaði þegar meðferð með metótrexati var hætt.
English: Talk to your doctor before using Nordimet if: - you have diabetes mellitus and are being treated with insulin - you have inactive, prolonged infections (e.g. tuberculosis, hepatitis B or C, shingles [herpes zoster]) - you have/had any liver or kidney disease - you have problems with lung function - you are severely overweight - you have abnormal accumulation of liquid in the abdomen or in the cavity between the lungs and chest wall (ascites, pleural effusions) - you are dehydrated or suffer from conditions leading to dehydration (e.g. dehydration as a result of vomiting, diarrhoea or inflammation of the mouth and lips)
Icelandic: - þú ert með insúlínháða sykursýki og færð insúlín - þú ert með óvirka, langvarandi sýkingu (t.d. berkla, lifrarbólgu B eða C, ristil [herpes zoster]) - þú ert/hefur verið með lifrar- eða nýrnasjúkdóm - vandamál eru með lungnastarfsemi - þú ert í mikilli yfirþyngd - þú ert með óeðlilega uppsöfnun vökva í kvið eða í holrúminu á milli lungna og brjóstveggjar
English: Salicylates, phenylbutazone, phenytoin, barbiturates, tranquillisers, oral contraceptives, tetracyclines, amidopyrine derivatives, sulfonamides and p-aminobenzoic acid displace methotrexate from serum albumin binding and thus increase bioavailability (indirect dose increase).
Icelandic: Salisýlöt, fenýlbútazón, fenýtóín, barbitúröt, róandi lyf, getnaðarvarnarlyf til inntöku, tetrasýklín, amídópýrín afleiður, súlfónamíð og p-amínóbensósýra valda tilfærslu á bindingu metótrexats við albúmín í sermi og auka þannig aðgengi (óbein skammtahækkun).
English: Each pack contains 1 pre-filled pen and one alcohol swab and multipacks containing 4 (4 packs of 1 or 1 pack of 4), 6 (6 packs of 1) and 12 (3 packs of 4) pre-filled pens and alcohol swabs.
Icelandic: 1 áfylltan penna og einn sprittklút og fjölpakkningar sem innihalda 4 (fjórar pakkningar með 1 eða 1 pakkning með 4), 6 (6 pakkningar með 1) og 12 (3 pakkningar með 4) áfyllta lyfjapenna og sprittklúta.
English: Incorrect administration of methotrexate can lead to severe, including potentially lethal adverse reactions.
Icelandic: Röng gjöf metótrexats getur valdið alvarlegum, þ.m.t. hugsanlega banvænum aukaverkunum.
English: Pre-filled syringe
Icelandic: Meðhöndlun ofskömmtunar
English: Any contact of methotrexate with skin and mucosa is to be avoided.
Icelandic: Forðast skal snertingu metótrexats við húð og slímhúð.
English: In case of renal insufficiency, elimination is delayed significantly.
Icelandic: Þegar um skerta nýrnastarfsemi er að ræða, hægist verulega á brotthvarfi.
English: Infections, severe failure of the bone marrow, liver failure, swollen glands, sleeplessness, pain, muscle weakness, pins and needles, changes in sense of taste (metallic taste), inflammation of the lining of the brain causing paralysis or vomiting, red eyes, damage to the retina of the eye, fluid in the lungs, vomiting blood, cold sores, protein in the urine, fever, loss of sex drive, problems having an erection, infection around a fingernail, severe complications of the gastrointestinal tract, boils, small blood vessels in the skin, fungal infections, damage to the blood vessels of the skin, vaginal discharge, infertility, male breast enlargement (gynaecomastia), inflammation of the brain, lymphoproliferative disorders (excessive growth of white blood cells).
Icelandic: Sýkingar, alvarleg beinmergsbilun, lifrarbilun, bólgnir eitlar, svefnleysi, verkir, vöðvaslappleiki, náladofi, breyting á bragðskyni (málmbragð), bólga í himnum heilans sem veldur lömun eða uppköstum, rauð augu, skemmdir á sjónu augans, vökvi í lungum, blóðuppköst, frunsur, prótein í þvagi, hiti, tap á kynhvöt, vandamál með stinningu, sýking í kringum fingurnögl, alvarlegir fylgikvillar í meltingarvegi, graftarkýli, litlar æðar í húðinni, sveppasýkingar, skemmdir á æðum í húð, útferð, ófrjósemi, brjóstastækkun hjá karlmönnum (kvenleg karlbrjóstastækkun), bólga í heila, illkynja eitilfrumufjölgun (óhófleg fjölgun hvítra blóðkorna).
English: Nordimet 22.5 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 22.5 mg methotrexate in 0.9 mL
Icelandic: Nordimet 22,5 mg stungulyf, lausn í áfylltum lyfjapenna Hver áfylltur lyfjapenni inniheldur 22,5 mg af metótrexati í 0,9 ml
English: Nordimet 10 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 10 mg methotrexate in 0.4 mL
Icelandic: Nordimet 10 mg stungulyf, lausn í áfylltum lyfjapenna Hver áfylltur lyfjapenni inniheldur 10 mg af metótrexati í 0,4 ml
English: This can lead to a loss of the medicine.
Icelandic: Það getur valdið tapi á lyfinu.
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.
Icelandic: Nordimet er ætlað til meðferðar á - virkri iktsýki hjá fullorðnum sjúklingum, - fjölliðagigtarformi af alvarlegri, virkri, sjálfvakinni barnaliðagigt (JIA) þegar svörun við bólgueyðandi gigtarlyfjum (NSAID) hefur reynst ófullnægjandi.
English: Chronic toxicity
Icelandic: Langvarandi eiturverkanir
English: Reduced blood cell formation with decrease in white and/or red blood cells and/or platelets (leukopenia, anaemia, thrombocytopenia), headache, tiredness, drowsiness, inflammation of the lungs (pneumonia) with dry, non-productive cough, shortness of breath and fever, diarrhoea, rash, reddening of the skin, itching.
Icelandic: Minnkuð blóðkornamyndun með fækkun hvítra og/eða rauðra blóðkorna og/eða blóðflagna (hvítfrumnafæð, blóðleysi, blóðflagnafæð), höfuðverkur, þreyta, syfja, bólga í lungum (lungnabólga) með þurrum hósta án uppgangs, mæði og hiti, niðurgangur, útbrot, roði í húð, kláði.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Icelandic: Ef þú átt í erfiðleikum með að meðhöndla sprautuna, skaltu spyrja lækninn eða lyfjafræðing.
English: Decrease in the number of blood cells and platelets , dizziness, confusion, depression, fits, inflammation of blood vessels, lung damage, ulcers and bleeding in the digestive tract, liver disorders, diabetes, decreased blood protein, nettle rash, light sensitivity, brown skin, hair loss, increase of rheumatic nodules, shingles, painful psoriasis, joint or muscle pain, osteoporosis (reduction of bone mass), inflammation and ulcers of the bladder (possibly with blood in the urine), painful urination, severe allergic reactions, inflammation and ulcers of the vagina, slow wound healing.
Icelandic: Fækkun blóðfrumna og blóðflagna, sundl, rugl, þunglyndi, flog, bólgur í æðum, lungnaskemmdir, sár og blæðingar í meltingarvegi, lifrarsjúkdómar, sykursýki, minnkuð prótein í blóði, ofsakláði, ljósnæmi, brún húð, hárlos, fjölgun gigtarhnúta, ristill, sársaukafullur sóri, vöðva- eða liðverkir, beinþynning (minnkun á beinþéttni), bólga og sár í þvagblöðru (hugsanlega með blóði í þvagi), sársaukafull þvaglát, alvarleg ofnæmisviðbrögð, bólga og sár í leggöngum, hæg sáragræðsla.
English: Very rare: Hepatic failure.
Icelandic: Ónæmiskerfi Mjög sjaldgæfar:
English: Important warning about the dosage of Nordimet
Icelandic: Mikilvæg varnaðarorð varðandi skömmtun Nordimet:
English: Nordimet 17.5 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 17.5 mg methotrexate in 0.7 mL
Icelandic: Nordimet 17,5 mg stungulyf, lausn í áfylltum lyfjapenna Hver áfylltur lyfjapenni inniheldur 17,5 mg af metótrexati í 0,7 ml
English: Nordimet 12.5 mg solution for injection methotrexate
Icelandic: Nordimet 12,5 mg stungulyf metótrexat
English: Subcutaneous use.
Icelandic: Þróun sykursýki.
English: Nordimet 22.5 mg solution for injection methotrexate
Icelandic: Nordimet 22,5 mg stungulyf metótrexat
English: - Concurrent vaccination with live vaccines.
Icelandic: - Samhliða bólusetning með lifandi bóluefnum.
English: Nordimet 12.5 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 12.5 mg methotrexate in 0.5 mL
Icelandic: Nordimet 12,5 mg stungulyf, lausn í áfylltum lyfjapenna Hver áfylltur lyfjapenni inniheldur 12,5 mg af metótrexati í 0,5 ml
English: Depending on the individual activity of the disease and patient tolerability, the initial dose may be increased.
Icelandic: Auka má við upphafsskammtinn eftir einstaklingsbundinni virkni sjúkdómsins og þoli sjúklingsins.
English: Inflammation of the sac around the heart, fluid in the sac around the heart, severe visual disturbance, mood fluctuations, low blood pressure, blood clots, sore throat, interruption of breathing, asthma, inflammation of the digestive tract, bloody stools, inflamed gums, abnormal digestion, acute hepatitis (inflammation of the liver), changed colour of nails, acne, red or purple spots due to vessel bleeding, bone fracture, kidney failure, decrease or absence of urine, electrolyte disturbances, defective sperm formation, menstruation disorders.
Icelandic: Bólga í pokanum umhverfis hjartað, uppsöfnun vökva inni í pokanum umhverfis hjartað, alvarlegar sjóntruflanir, skapsveiflur, lágur blóðþrýstingur, blóðtappar, særindi í hálsi, truflun á öndun, astmi, bólga í meltingarvegi, blóð í hægðum, bólgnir gómar, óeðlileg melting, bráð lifrarbólga (bólga í lifur), breyttur litur á nöglum, þrymlabólur, rauðir eða fjólubláir blettir vegna blæðinga úr æðum, beinbrot, nýrnabilun, minnkuð eða engin þvagframleiðsla, óeðlileg blóðsölt, galli í sæðismyndun, tíðavandamál.
English: There are reports of death due to sepsis, septic shock, renal failure and aplastic anaemia.
Icelandic: Tilkynnt hefur verið um dauðsföll vegna sýklasóttar, sýklasóttarlosts, nýrnabilunar og vanmyndunarblóðleysis.
English: Therefore, the combination of these may require dose adjustment.
Icelandic: Því gæti þurft að aðlaga skammta við samhliða gjöf þeirra.
English: Pre-filled syringes of 0.3 ml containing 7.5 mg methotrexate.
Icelandic: Áfylltar 0,3 ml sprautur með 7,5 mg af metótrexati Áfylltar 0,4 ml sprautur með 10 mg af metótrexati.
English: Nordimet 25 mg solution for injection methotrexate
Icelandic: Nordimet 25 mg stungulyf metótrexat
English: Nordimet 10 mg solution for injection methotrexate
Icelandic: Nordimet 10 mg stungulyf metótrexat
English: Nordimet 17.5 mg solution for injection methotrexate
Icelandic: Nordimet 17,5 mg stungulyf metótrexat
English: The most relevant adverse reaction is suppression of the haematopoietic system and gastrointestinal disorders.
Icelandic: Mikilvægustu aukaverkanirnar eru bæling á blóðfrumnamyndandi kerfinu og meltingarfæratruflanir.
English: In combination with pantoprazole, inhibited renal elimination of the 7-hydroxymethotrexate metabolite, with myalgia and shivering, was reported in one case.
Icelandic: Við samhliða gjöf pantóprazóls var tilkynnt um skert brotthvarf á umbrotsefninu 7-hýdroxýmetótrexati um nýru ásamt vöðvaþrautum og kuldahrolli hjá einum sjúklingi.
English: Nordimet 20 mg solution for injection methotrexate
Icelandic: Nordimet 20 mg stungulyf metótrexat
English: It acts by the competitive inhibition of the enzyme dihydrofolate reductase and thus inhibits DNA synthesis.
Icelandic: Það verkar samkeppnishamlandi á ensímið díhýdrófólatredúktasa og hamlar þannig DNA-myndun.
English: Nordimet 7.5 mg solution for injection methotrexate
Icelandic: Nordimet 7,5 mg stungulyf metótrexat
English: The average weekly dose is 15-20 mg. Generally, a weekly dose of 25 mg should not be exceeded.
Icelandic: Meðal vikuskammturinn er 15-20 mg.
English: reactivation of inactive chronic infection), sepsis, conjunctivitis.
Icelandic: Sýking (þ.m.t. endurvirkjun á óvirkri langvinnri sýkingu), sýklasótt, tárubólga.
English: Nordimet 7.5 mg solution for injection in pre-filled syringe Nordimet 10 mg solution for injection in pre-filled syringe Nordimet 12.5 mg solution for injection in pre-filled syringe Nordimet 15 mg solution for injection in pre-filled syringe Nordimet 17.5 mg solution for injection in pre-filled syringe Nordimet 20 mg solution for injection in pre-filled syringe Nordimet 22.5 mg solution for injection in pre-filled syringe Nordimet 25 mg solution for injection in pre-filled syringe
Icelandic: Nordimet 7,5 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 10 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 12,5 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 15 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 17,5 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 20 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 22,5 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 25 mg stungulyf, lausn í áfylltum lyfjapenna
English: Nordimet 7.5 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 7.5 mg methotrexate in 0.3 mL
Icelandic: Nordimet 7,5 mg stungulyf, lausn í áfylltum lyfjapenna Hver áfylltur lyfjapenni inniheldur 7,5 mg af metótrexati í 0,3 ml
English: Nordimet 7.5 mg solution for injection in pre-filled syringe Nordimet 10 mg solution for injection in pre-filled syringe Nordimet 12.5 mg solution for injection in pre-filled syringe Nordimet 15 mg solution for injection in pre-filled syringe Nordimet 17.5 mg solution for injection in pre-filled syringe Nordimet 20 mg solution for injection in pre-filled syringe Nordimet 22.5 mg solution for injection in pre-filled syringe Nordimet 25 mg solution for injection in pre-filled syringe methotrexate
Icelandic: Nordimet 7,5 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 10 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 12,5 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 15 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 17,5 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 20 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 22,5 mg stungulyf, lausn í áfylltum lyfjapenna Nordimet 25 mg stungulyf, lausn í áfylltum lyfjapenna metótrexat
English: Very rare: Pain, muscular asthenia or paraesthesia in the extremities, changes in sense of taste (metallic taste), convulsions, meningism, acute aseptic meningitis, paralysis.
Icelandic: Verkur, vöðvaslappleiki eða náladofi í útlimum, breytingar á bragðskyni (málmbragð), krampar, mengiserting, bráð heilahimnubólgu án sýkingar, lömun.
English: It is associated with malformations of the skull, face, heart and blood vessels, brain and limbs.
Icelandic: andliti, hjarta og æðum, heila og útlimum.
English: Rare: Mood alterations.
Icelandic: Æðar Mjög sjaldgæfar:
English: Discard the used pen into the sharps bin provided.
Icelandic: Fargaðu notaða pennanum í meðfylgjandi ílát fyrir oddhvöss áhöld.
English: If you develop any of the following side effects, contact your doctor immediately: - inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness of breath, breathlessness at rest, chest pain, or fever) - spitting or coughing blood - severe peeling or blistering of the skin - unusual bleeding (including vomiting blood) or bruising - severe diarrhoea - ulcers in mouth - black or tarry stools - blood in the urine or stools - tiny red spots on the skin - fever - yellowing of the skin (jaundice) - pain or difficulty in passing urine - thirst and/or frequent urination - fits (convulsions) - loss of consciousness - blurred or decreased vision
Icelandic: brjóstverkur eða hiti) - blóðugur uppgangur eða blóðhósti - alvarleg flögnun eða blöðrumyndun á húð - óvenjulegar blæðingar (þ.m.t. blóðug uppköst) eða marblettir - alvarlegur niðurgangur - sár í munni - svartar eða tjörukenndar hægðir - blóð í þvagi eða hægðum - litlir rauðir blettir á húðinni - hiti - gulnun húðar (gula) - verkur eða erfiðleikar við þvaglát - þorsti og/eða tíð þvaglát - flog (krampar) - meðvitundarleysi - þokusýn eða minnkuð sjón
English: Common: Leukopenia, anaemia, thrombopenia.
Icelandic: Liðverkir, vöðvaverkir, beinþynning.
English: Batch:
Icelandic: ATCflokkur:
English: PRE-FILLED SYRINGE CARTON NO BLUE BOX IS INCLUDED
Icelandic: ASKJA MEÐ ÁFYLLTRI SPRAUTU ÁN „BLUE BOX“
English: Nordimet 15 mg solution for injection methotrexate
Icelandic: Nordimet 15 mg stungulyf metótrexat
English: One pre-filled syringe of 0.9 ml contains 22.5 mg methotrexate (25mg/ml)
Icelandic: Hver 0,9 ml áfyllt sprauta inniheldur 22,5 mg af metótrexati (25 mg/ml)
English: Pronounced enterohepatic blood flow exists.
Icelandic: Áberandi lifrarþarmahringrás er til staðar.
English: For contraception advice for men, see section 4.6.
Icelandic: Samantekt á eiginleikum lyfs, kafla 4.2).
English: One pre-filled pen of 1.0 ml contains 25 mg methotrexate (25mg/ml)
Icelandic: Hver 1,0 ml áfyllt sprauta inniheldur 25 mg af metótrexati (25 mg/ml)
English: Nordimet 25 mg solution for injection in pre-filled pen EU/1/16/1124/008 - 1 pack EU/1/16/1124/023 - 4 pack (4 packs of 1) EU/1/16/1124/024 - 6 pack EU/1/16/1124/071 - 4 pack (1 pack of 4) EU/1/16/1124/072 - 12 pack
Icelandic: Nordimet 25 mg stungulyf, lausn í áfylltum lyfjapenna EU/1/16/1124/008 - 1 pakkning EU/1/16/1124/023 - 4 pakkningar (4 pakkningar með 1) EU/1/16/1124/024 - 6 pakkningar EU/1/16/1124/071 - 4 pakkningar (1 pakkning með 4) EU/1/16/1124/072 - 12 pakkningar
English: One pre-filled syringe of 0.8 ml contains 20 mg methotrexate (25mg/ml)
Icelandic: Hver 0,8 ml áfyllt sprauta inniheldur 20 mg af metótrexati (25 mg/ml)
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other immunosuppressants.
Icelandic: Æxlishemjandi lyf og lyf til ónæmistemprunar, önnur ónæmisbælandi lyf.
English: Methotrexate is contraindicated during pregnancy in non-oncological indications (see section 4.3).
Icelandic: Ekki má nota metótrexat á meðgöngu við ábendingum sem ekki tengjast krabbameini (sjá kafla 4.3).
English: During therapy
Icelandic: Meðan á meðferð stendur
English: - Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease.
Icelandic: - Munnbólga, sár í munnholi og þekkt virk sár í meltingarvegi.
English: Rare: Renal failure, oliguria, anuria, electrolyte disturbances.
Icelandic: Munnbólga, meltingartruflanir, ógleði, lystarleysi, kviðverkur.
English: Nordimet 20 mg solution for injection in pre-filled syringe methotrexate
Icelandic: Nordimet 20 mg stungulyf, lausn í áfylltri sprautu metótrexat
English: 4 pre-filled pens (1 ml) with pre-assembled needle and 4 alcohol swabs.
Icelandic: 4 áfylltir lyfjapennar (1 ml) með forsamsettri nál og 4 sprittþurrkum.
English: Nordimet 10 mg solution for injection in pre-filled syringe methotrexate
Icelandic: Nordimet 10 mg stungulyf, lausn í áfylltri sprautu metótrexat
English: EU/1/16/1124/025 1 pre-filled syringe EU/1/16/1124/026 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/027 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/049 12 pre-filled syringes (12 packs of 1)
Icelandic: EU/1/16/1124/025 1 áfyllt sprauta EU/1/16/1124/026 4 áfylltar sprautur (4 pakkningar með 1) EU/1/16/1124/027 6 áfylltar sprautur (6 pakkningar með 1) EU/1/16/1124/049 12 áfylltar sprautur (12 pakkningar með 1)
English: Uncommon: Dizziness.
Icelandic: - Ónæmisbrestur.
English: EU/1/16/1124/009 4 pre-filled pens (4 packs of 1) EU/1/16/1124/010 6 pre-filled pens (6 packs of 1) EU/1/16/1124/058 12 pre-filled pens (3 packs of 4)
Icelandic: EU/1/16/1124/009 4 áfylltir pennar (4 pakkningar með 1) EU/1/16/1124/010 6 áfylltir pennar (6 pakkningar með 1) EU/1/16/1124/058 12 áfylltir pennar (3 pakkningar með 4)
English: Impaired elimination in presence of hepatic insufficiency is not known.
Icelandic: Ekki er vitað hvort skert lifrarstarfsemi hafi áhrif á brotthvarf.
English: One pre-filled pen of 0.5 ml contains 12.5 mg methotrexate (25mg/ml)
Icelandic: Hver 0,5 ml áfyllt sprauta inniheldur 12,5 mg af metótrexati (25 mg/ml)
English: - Immunodeficiency.
Icelandic: Lifrarbilun.
English: Common (may affect up to 1 in 10 people):
Icelandic: Mjög algengar (geta komið fyrir hjá fleirum en 1 af hverjum 10 einstaklingum):
English: Nordimet 25 mg solution for injection in pre-filled syringe methotrexate
Icelandic: Nordimet 25 mg stungulyf, lausn í áfylltri sprautu metótrexat
English: Nordimet 20 mg solution for injection in pre-filled pen EU/1/16/1124/006 - 1 pack EU/1/16/1124/019 - 4 pack (4 packs of 1) EU/1/16/1124/020 - 6 pack EU/1/16/1124/067 - 4 pack (1 pack of 4) EU/1/16/1124/068 - 12 pack
Icelandic: Nordimet 20 mg stungulyf, lausn í áfylltum lyfjapenna EU/1/16/1124/006 - 1 pakkning EU/1/16/1124/019 - 4 pakkningar (4 pakkningar með 1) EU/1/16/1124/020 - 6 pakkningar EU/1/16/1124/067 - 4 pakkningar (1 pakkning með 4) EU/1/16/1124/068 - 12 pakkningar
English: - Severe renal impairment (creatinine clearance less than 30 ml/min) (see sections 4.2 and 4.4).
Icelandic: - Verulega skert nýrnastarfsemi (kreatínínúthreinsun minni en 30 ml/mín.)
English: EU/1/16/1124/026 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/027 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/049 12 pre-filled syringes (12 packs of 1)
Icelandic: EU/1/16/1124/026 4 áfylltar sprautur (4 pakkningar með 1) EU/1/16/1124/027 6 áfylltar sprautur (6 pakkningar með 1) EU/1/16/1124/049 12 áfylltar sprautur (12 pakkningar með 1)
English: One pre-filled syringe of 0.4 ml contains 10 mg methotrexate (25mg/ml)
Icelandic: Hver 0,4 ml áfyllt sprauta inniheldur 10 mg af metótrexati (25 mg/ml)
English: Any used syringe should be discarded.
Icelandic: Farga skal öllum notuðum sprautum.
English: The following pens are available:
Icelandic: Eftirfarandi sprautur eru fáanlegar:
English: However, doses exceeding 20 mg per week can be associated with significant increase in toxicity, especially bone marrow suppression.
Icelandic: Þó má tengja verulega aukningu eiturverkana, einkum beinmergsbælingu, við skammta sem eru stærri en 20 mg á viku.
English: 1 pre-filled syringe (0.7 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Icelandic: 1 áfyllt sprauta (0,7 ml) með forsamsettri nál með nálarvörn og 2 sprittþurrkum.