FrancophonIA/ELRC3.0 huggingface dataset:
English: 2 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 12 pre-filled syringes with needle guard 20 pre-filled syringes with needle guard 24 pre-filled syringes with needle guard 30 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 10 pre-filled syringes with UltraSafe Passive needle guard
Icelandic: 2 áfylltar sprautur með nálarvörn 6 áfylltar sprautur með nálarvörn 10 áfylltar sprautur með nálarvörn 12 áfylltar sprautur með nálarvörn 20 áfylltar sprautur með nálarvörn 24 áfylltar sprautur með nálarvörn 30 áfylltar sprautur með nálarvörn 2 áfylltar sprautur með UltraSafe nálarvörn 10 áfylltar sprautur með UltraSafe nálarvörn
English: Immuno-allergic thrombocytopenia β: Platelet increased >400 G/L
Icelandic: Ofnæmisblóðflagna fæð β Blóðflögur aukning > 400 g/l
English: The syringe can be additionally equipped with needle guard; or - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a white polycarbonate plunger rod equipped with UltraSafe Passive needle guard.
Icelandic: Sprautan getur auk þess verið útbúin með nálarvörn; eða - glærum, litlausum sprautuhólki úr gleri af gerð I með áfastri nál og nálarhlíf sem lokað er með tappa úr klóróbútýlgúmmí og hvítur polycarbonate stimpilstöng.
English: Enoxaparin sodium may be safely administered with sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose in water for injections.
Icelandic: Enoxaparin natríum má með öruggum hætti gefa með natríumklóríð 9 mg/ml (0,9%) innrennslislyfi, lausn eða 5% glúkósa í vatni fyrir stungulyf.
English: Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection enoxaparin sodium
Icelandic: Inhixa 2.000 a.e. (20 mg)/0,2 ml stungulyf, lausn Enoxaparín
English: - 5 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and grey aluminium-plastic cap in a cardboard box.
Icelandic: - 5 ml af lausn í glæru, litlausu hettuglasi úr gleri af gerð I sem innsiglað er með inndælingartappa úr gúmmíi og grárri ál-plasthettu í pappaöskju.
English: Inhixa 12,000 IU (120 mg)/0.8 mL
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Inhixa 12.000 a.e. (120 mg)/0,8 ml
English: Inhixa 6,000 IU (60 mg)/0.6 mL solution for injection enoxaparin sodium
Icelandic: Inhixa 6.000 a.e. (60 mg)/ 0,6 ml stungulyf, lausn enoxaparín
English: Each pre-filled syringe of 1 mL contains 10,000 IU (100 mg) of enoxaparin sodium.
Icelandic: Hver áfyllt sprauta með 1 ml inniheldur 10.000 a.e. (100 mg) af enoxaparín natríum.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Icelandic: Við meðgöngu, brjóstagjöf, grun um þungun eða ef þungun er fyrirhuguð skal leita ráða hjá lækninum eða lyfjafræðingi áður en lyfið er notað.
English: 0.2 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a blue polypropylene plunger rod.
Icelandic: 0,2 ml af lausn í: - glærum, litlausum sprautuhólki úr gleri af gerð I með áfastri nál og nálarhlíf sem lokað er með tappa úr klóróbútýlgúmmí og blárri pólýprópýlen stimpilstöng.
English: CARTON OF (Packs of 2, 6, 10, 12, 24 or 30)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM ASKJA MEÐ (pakkningar með 2, 6, 10, 12, 24 eða 30)
English: Inhixa 12,000 IU (120 mg)/0.8 mL injection enoxaparin sodium
Icelandic: Ein áfyllt sprauta (0,8 ml) inniheldur 12.000 a.e. (120 mg) enoxaparin natríum
English: Inhixa 4,000 IU (40 mg)/0.4 mL solution for injection
Icelandic: Inhixa 4.000 a.e. (40 mg)/0,4 ml stungulyf, lausn
English: The mean maximum plasma anti-Xa activity level is observed 3 to 5 hours after subcutaneous injection and achieves approximately 0.2, 0.4, 1.0 and 1.3 anti-Xa IU/mL following single subcutaneous administration of 2,000 IU, 4,000 IU, 100 IU/kg and 150 IU/kg (20 mg, 40 mg, 1 mg/kg and 1.5 mg/kg) doses, respectively.
Icelandic: eftir inndælingu undir húð og nær um 0,2, 0,4, 1,0 og 1,3 and-Xa a.e./ml eftir gjöf 20 mg, 40 mg, 1 mg/kg og 1,5 mg/kg skammta, talið upp i sömu röð.
English: Thrombocytop enia
Icelandic: B. FYLGISEÐILL
English: Inhixa 12,000 IU (120 mg)/0.8 mL solution for injection enoxaparin sodium
Icelandic: Inhixa 12.000 a.e. (120 mg)/0,8 ml stungulyf, lausn enoxaparín natríum
English: 3 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and white aluminium-plastic cap in a cardboard box.
Icelandic: 3 ml af lausn í glæru, litlausu hettuglasi úr gleri af gerð I sem innsiglað er með inndælingartappa úr gúmmíi og hvítri ál-plasthettu í pappaöskju.
English: - 10 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and white aluminium-plastic cap in a cardboard box.
Icelandic: - 10 ml af lausn í glæru, litlausu hettuglasi úr gleri af gerð I sem innsiglað er með inndælingartappa úr gúmmíi og hvítri ál-plasthettu í pappaöskju.
English: What Inhixa looks like and contents of the pack Inhixa 12,000 IU (120 mg)/0.8 mL is 0.8 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a purple polypropylene plunger rod.
Icelandic: Inhixa 12.000 a.e. (120 ml)/0,8 ml er 0,8 ml af lausn í: glærum, litlausum sprautuhólki úr gleri af gerð I með áfastri nál og nálarhlíf sem lokað er með tappa úr klóróbútýlgúmmí og fjólublárri pólýprópýlen stimpilstöng.
English: 10 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and white aluminium-plastic cap in a cardboard box.
Icelandic: 10 ml ml af lausn í glæru, litlausu hettuglasi úr gleri af gerð I sem innsiglað er með inndælingartappa úr gúmmíi og hvítri ál-plasthettu í pappaöskju.
English: No IV initial bolus, 100 IU/kg (1 mg/kg) body weight SC and then 100 IU/kg (1 mg/kg) body weight SC every 24 hours
Icelandic: Ekki hleðsluskammtur í bláæð, 100 a.e./kg (1 mg/kg) líkamsþyngdar undir húð og síðan 100 a.e./kg (1 mg/kg) líkamsþyngdar undir húð á 24 klst. fresti
English: 5 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and grey aluminium-plastic cap in a cardboard box.
Icelandic: 5 ml af lausn í glæru, litlausu hettuglasi úr gleri af gerð I sem innsiglað er með inndælingartappa úr gúmmíi og grárri ál-plasthettu í pappaöskju.
English: - Changing from Inhixa to treatment with direct oral anticoagulant Stop taking Inhixa.
Icelandic: - Skipt úr Inhixa í meðferð með blóðþynningarlyfjum til inntöku með beina verkun Hætta á töku Inhixa.
English: In clinical studies, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions (see sections 4.4 and “Description of selected adverse reactions” below).
Icelandic: Í klínískum rannsóknum voru algengustu aukaverkanirnar sem greint var frá blæðingar, blóðflagnafæð og blóðflagnafjölgun (sjá kafla 4.4 og „Lýsingu á völdum aukaverkunum“ hér á eftir).
English: Inhixa 8,000 IU (80 mg)/0.8 mL solution for injection enoxaparin sodium
Icelandic: Inhixa 8.000 a.e. (80 mg)/ 0,8 ml stungulyf, lausn enoxaparín
English: Very common: Thrombocytosi s β
Icelandic: Mjög algengar Blóðflagnafjölgun β
English: Enoxaparin sodium may be safely administered with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% dextrose in water (see section 4.2).
Icelandic: Inndæling (á hleðsluskammti) í bláæð (eingöngu fyrir STEMI ábendinguna) Enoxaparin natríum má með öruggum hætti gefa með natríumklóríð 9 mg/ml (0,9%) stungulyfi, lausn eða 5% dextrósa í vatni (sjá kafla 4.2).
English: Illness
Icelandic: Meðferð
English: Additional bolus for PCI when last subcutaneous administration was given more than 8 hours before balloon inflation
Icelandic: Viðbótarhleðsluskammtur fyrir kransæðavíkkun þegar síðasti skammtur undir húð hefur verið gefinn meira en 8 klst.
English: Packs of: - 2, 5, 6, 10, 30 and 50 pre-filled syringes - 2, 5, 6, 10, 20, 30, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard
Icelandic: - 2, 5, 6, 10, 30 eða 50 áfylltum sprautum - 2, 5, 6, 10, 20, 30, 50 eða 90 áfylltum sprautum með nálarvörn - 2 eða 6 áfylltum sprautum með UltraSafe Passive nálarvörn
English: 1 mL of solution in a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a dark blue polypropylene plunger rod.
Icelandic: 1 ml af lausn í glærum, litlausum sprautuhólki úr gleri af gerð I með áfastri nál og nálarhlíf sem lokað er með tappa úr klóróbútýlgúmmí og dökkblárri pólýprópýlen stimpilstöng.
English: EU/1/16/1132/007 EU/1/16/1132/008 EU/1/16/1132/017 EU/1/16/1132/018 EU/1/16/1132/029 EU/1/16/1132/030 EU/1/16/1132/039 EU/1/16/1132/040 EU/1/16/1132/047 EU/1/16/1132/048 EU/1/16/1132/059 EU/1/16/1132/060 EU/1/16/1132/084
Icelandic: EU/1/16/1132/008 EU/1/16/1132/017 EU/1/16/1132/018 EU/1/16/1132/029 EU/1/16/1132/030 EU/1/16/1132/039 EU/1/16/1132/040 EU/1/16/1132/047 EU/1/16/1132/048 EU/1/16/1132/059 EU/1/16/1132/060 EU/1/16/1132/084
English: Before injecting yourself with Inhixa
Icelandic: Áður en byrjað er að nota Inhixa
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Icelandic: Inndæling (á hleðsluskammti) í bláæð (eingöngu fyrir STEMI ábendinguna) Ekki má blanda þessu lyfi saman við önnur lyf en þau sem nefnd eru í kafla 6.6.
English: INSTRUCTIONS FOR USE: PRE-FILLED SYRINGE
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI
English: Inhixa 10,000 IU (100 mg)/1 mL solution for injection enoxaparin sodium
Icelandic: Inhixa 10.000 a.e. (100 mg)/ 1 ml stungulyf, lausn enoxaparín
English: The air bubble should not be expelled from the syringe before the injection to avoid the loss of drug when using pre-filled syringes.
Icelandic: Ekki á að fjarlægja loftbólur úr áfylltu sprautunni fyrir inndælingu þá getur hluti af lyfinu farið forgörðum.
English: Enoxaparin sodium 100 IU/kg (1 mg/kg) twice a day subcutaneously n (%)
Icelandic: Enoxaparin natríum 100 a.e./kg (1 mg/kg) tvisvar á dag undir húð
English: Inhixa 12,000 IU (120 mg)/0.8 mL solution for injection
Icelandic: Inhixa 12.000 a.e. (120 mg)/0,8 ml stungulyf, lausn
English: EU/1/16/1132/005 EU/1/16/1132/006 EU/1/16/1132/015 EU/1/16/1132/016 EU/1/16/1132/026 EU/1/16/1132/027 EU/1/16/1132/028 EU/1/16/1132/037 EU/1/16/1132/038 EU/1/16/1132/045 EU/1/16/1132/046 EU/1/16/1132/057 EU/1/16/1132/058 EU/1/16/1132/083
Icelandic: EU/1/16/1132/006 EU/1/16/1132/015 EU/1/16/1132/016 EU/1/16/1132/026 EU/1/16/1132/027 EU/1/16/1132/028 EU/1/16/1132/037 EU/1/16/1132/038 EU/1/16/1132/045 EU/1/16/1132/046 EU/1/16/1132/057 EU/1/16/1132/058 EU/1/16/1132/083
English: 0.8 mL of solution in: - a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a red polypropylene plunger rod.
Icelandic: 0,8 ml af lausn í : glærum, litlausum, kvörðuðum sprautuhólki úr gleri af gerð I með áfastri nál og nálarhlíf sem lokað er með tappa úr klóróbútýlgúmmí og rauðri pólýprópýlen stimpilstöng.
English: 8 hours before balloon inflation, no additional dosing is needed.
Icelandic: fyrir blástur þarf ekki að gefa viðbótarskammt.
English: EU/1/16/1132/009 EU/1/16/1132/010 EU/1/16/1132/019 EU/1/16/1132/020 EU/1/16/1132/022 EU/1/16/1132/031 EU/1/16/1132/032 EU/1/16/1132/041 EU/1/16/1132/042 EU/1/16/1132/049 EU/1/16/1132/050 EU/1/16/1132/061 EU/1/16/1132/062 EU/1/16/1132/063
Icelandic: EU/1/16/1132/010 EU/1/16/1132/019 EU/1/16/1132/020 EU/1/16/1132/022 EU/1/16/1132/031 EU/1/16/1132/032 EU/1/16/1132/041 EU/1/16/1132/042 EU/1/16/1132/049 EU/1/16/1132/050 EU/1/16/1132/061 EU/1/16/1132/062 EU/1/16/1132/063
English: • An initial dose of 3,000 IU (30 mg) of Inhixa will be given as injection into your vein.
Icelandic: Þú færð 3.000 a.e. (30 mg) af Inhixa sem upphafsskammt í bláæð.
English: 0.6 mL of solution in: - a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and an orange polypropylene plunger rod.
Icelandic: 0,6 ml af lausn í : glærum, litlausum, kvörðuðum sprautuhólki úr gleri af gerð I með áfastri nál og nálarhlíf sem lokað er með tappa úr klóróbútýlgúmmí og appelsínugulri pólýprópýlen stimpilstöng.
English: Pre-filled syringe
Icelandic: Heildartilvik bláæðasega
English: Inhixa 6,000 IU (60 mg)/0.6 mL solution for injection
Icelandic: Inhixa 6.000 a.e. (60 mg)/0,6 ml stungulyf, lausn
English: Packs of: - 1, 2, 6, 10 and 50 pre-filled syringe(s) - 2, 6, 10, 20, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard
Icelandic: - 1, 2, 6, 10 eða 50 áfyllt(um) sprauta(um) - 2, 6, 10, 20, 50 eða 90 áfylltum sprautum með nálarvörn - 2 eða 6 áfylltum sprautum með UltraSafe Passive nálarvörn
English: 1 mL of solution in: - a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a black polypropylene plunger rod.
Icelandic: 1 ml af lausn í : glærum, litlausum, kvörðuðum sprautuhólki úr gleri af gerð I með áfastri nál og nálarhlíf sem lokað er með tappa úr klóróbútýlgúmmí og svartri pólýprópýlen stimpilstöng.
English: Inhixa 15,000 IU (150 mg)/1 mL solution for injection
Icelandic: Inhixa 15.000 a.e. (150 mg)/1 ml stungulyf, lausn
English: Diluted medicinal product with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose
Icelandic: Þynnt lyf með natríumklóríð 9 mg/ml (0,9%) stungulyfi,lausn eða 5% glúkósa í vatni.
English: For the prophylaxis of venous thrombo-embolic disease following surgery, treatment of DVT and PE, treatment of unstable angina and NSTEMI, enoxaparin sodium should be administered by subcutaneous injection.
Icelandic: Til að fyrirbyggja bláæðasegasjúkdóm í kjölfar skurðaðgerðar, við meðferð á djúpbláæðasega og blóðsegareki til lungna, við meðferð á hvikulli hjartaöng og hjartadrepi án ST-hækkunar á að gefa enoxaparin natríum með inndælingu undir húð.
English: Packs of: - 2, 6, 10, 30, 50 and 90 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Icelandic: - 2, 6, 10, 30, 50 eða 90 áfylltum sprautum - 2, 6, 10, 12, 24 eða 30 áfylltum sprautum með nálarvörn - 2 eða 10 áfylltum sprautum með UltraSafe Passive nálarvörn
English: Switch between enoxaparin sodium and direct oral anticoagulants (DOAC) For patients currently receiving enoxaparin sodium, discontinue enoxaparin sodium and start the DOAC 0 to 2 hours before the time that the next scheduled administration of enoxaparin sodium would be due as per DOAC label.
Icelandic: Hjá sjúklingum sem þegar fá enoxaparin natríum á að hætta notkun þessa og hefja notkun segavarnarlyfja til inntöku með beina verkun 0 til 2 klst.
English: Following repeated subcutaneous administration no accumulation takes place.
Icelandic: fyrir aðgerð samræmist ekki mænu/utanbastsdeyfingu.
English: The absolute bioavailability of enoxaparin sodium after subcutaneous injection, based on anti-Xa activity, is close to 100%.
Icelandic: Frásog Nýting enoxaparin natríum eftir inndælingu undir húð þegar mið er tekið af and-Xa virkni er nálægt
English: Packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 20, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Icelandic: - 2, 6, 10, 30 eða 50 áfylltum sprautum - 2, 6, 10, 12, 20, 24 eða 30 áfylltum sprautum með nálarvörn - 2 eða 10 áfylltum sprautum með UltraSafe Passive nálarvörn
English: Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection
Icelandic: Inhixa 2.000 a.e. (20 mg)/0,2 ml stungulyf, lausn
English: Inhixa 10,000 IU (100 mg)/1 mL solution for injection
Icelandic: Inhixa 10.000 a.e. (100 mg)/1 ml stungulyf, lausn
English: Treatment in patients with unstable angina and non-Qwave MI
Icelandic: Sjúklingar með hvikula hjartaöng og ógegndrægt (non Qwave) hjartadrep
English: • Proximal DVT (%)
Icelandic: Nálægur djúpbláæðasegi (%)
English: 30 IU/kg (0.3 mg/kg) enoxaparin sodium should be administered.
Icelandic: Ráðlagður skammtur er 100 a.e./kg (1 mg/kg) af enoxaparin natríum.
English: Inhixa 8,000 IU (80 mg)/0.8 mL solution for injection
Icelandic: Inhixa 8.000 a.e. (80 mg)/0,8 ml stungulyf, lausn
English: Total VTE (%)
Icelandic: Eingöngu djúpbláæðasegi (%)
English: 2) Stopping blood clots forming in your blood.
Icelandic: Kemur í veg fyrir blóðtappamyndun við blóðskilun
English: Thrombocytopenia
Icelandic: Brotthvarf
English: Plasma anti-IIa activity after subcutaneous administration is approximately ten-fold lower than anti-Xa activity.
Icelandic: Virkni and-IIa í plasma eftir gjöf undir húð er u.þ.b. 10 sinnum minni en virkni and-Xa.
English: 0.4 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a yellow polypropylene plunger rod.
Icelandic: 0,4 ml af lausn í: glærum, litlausum sprautuhólki úr gleri af gerð I með áfastri nál og nálarhlíf sem lokað er með tappa úr klóróbútýlgúmmí og gulri pólýprópýlen stimpilstöng.
English: Packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Icelandic: - 2, 6, 10, 30 eða 50 áfylltum sprautum - 2, 6, 10, 12, 24 eða 30 áfylltum sprautum með nálarvörn - 2 eða 10 áfylltum sprautum með UltraSafe Passive nálarvörn
English: Treatment in patients with acute STEMI
Icelandic: Fyrirbyggjandi meðferð hjá skurðsjúklingum
English: Musculoskeletal, connective tissue and bone disorders • Rare: Osteoporosis* following long term therapy (greater than 3 months)
Icelandic: Aukning lifrarensíma (aðallega transamínasa > 3-föld eðlileg efri mörk)
English: • Enoxaparin sodium is not recommended for patients with end stage renal disease (creatinine clearance <15 mL/min) due to lack of data in this population outside the prevention of thrombus formation in extra corporeal circulation during haemodialysis.
Icelandic: (kreatínínúthreinsun <15 ml/mín.) þar sem upplýsingar liggja ekki fyrir hjá þessum hóp fyrir utan fyrirbyggjandi meðferð við segamyndun í hringrás utan líkamans við blóðskilun.
English: Enoxaparin sodium is not recommended for patients with end stage renal disease (creatinine clearance < 15 mL/min) due to lack of data in this population outside the prevention of thrombus formation in extra corporeal circulation during haemodialysis.
Icelandic: Enoxaparin natríum er ekki ráðlagt hjá sjúklingum lokastigsnýrnasjúkdóm (kreatínínúthreinsun <15 ml/mín.)
English: SC injection.
Icelandic: Lyfseðilsskylt lyf.
English: Treatment in patients with unstable angina and non-Q-wave MI
Icelandic: Sjúklingar með hvikula hjartaöng og ógegndrægt (non Q- wave) hjartadrep
English: 2 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 20 pre-filled syringes with needle guard 50 pre-filled syringes with needle guard 90 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 6 pre-filled syringes with UltraSafe Passive needle guard
Icelandic: 2 áfylltar sprautur með nálarvörn 6 áfylltar sprautur með nálarvörn 10 áfylltar sprautur með nálarvörn 20 áfylltar sprautur með nálarvörn 50 áfylltar sprautur með nálarvörn 90 áfylltar sprautur með nálarvörn
English: Common: Thrombocytosisβ
Icelandic: 13. LOTUNÚMER
English: 75236 Uppsala Sweden
Icelandic: Uppsala Svíþjóð
English: • you are going to receive spinal or epidural anesthesia or lumbar puncture (see Operations and
Icelandic: þú munt gangast undir mænu- eða utanbastsdeyfingu eða mænuástungu (sjá kaflann „Aðgerðir og svæfing“): tími skal líða á milli INHIXA og þessarar aðgerðar.
English: Age ≥ 65 years
Icelandic: Aldur ≥ 65 ár
English: Date of first authorisation: 18 January 2017
Icelandic: 18. janúar 2017
English: Activity in vitro and in vivo
Icelandic: Verkun in vitro og in vivo
English: It binds to C. difficile toxin B.
Icelandic: Það binst C. difficile toxíni B.
English: • You and your doctor should decide together if you will use ZINPLAVA.
Icelandic: Þú og læknirinn ákveðið í sameiningu hvort þú ætlir að nota ZINPLAVA.
English: The median age was 65 years, 85 % were white, 57 % were female, and 68 % were inpatients.
Icelandic: Miðgildisaldur var 65 ár, 85 % voru hvítir, 57 % konur og 68 % innlagðir sjúklingar.
English: Industriepark 30 - Zone A 2220 Heist-op-den-Berg Belgium
Icelandic: Industriepark 30 - Zone A 2220 Heist-op-den-Berg Belgía
English: Adjusted Difference (95% CI)
Icelandic: Aðlagaður mismunur (95% CI)
English: Common (may affect up to 1 in 10 people)
Icelandic: Algengar (geta komið fyrir hjá 1 af hverjum 10 einstaklingum)
English: • It is very important that you do not miss the dose of this medicine.
Icelandic: Mjög mikilvægt er að missa ekki úr skammt af lyfinu.
English: The mean volume of distribution of bezlotoxumab was 7.33 L (CV: 16 %).
Icelandic: Meðaldreifingarrúmmál bezlotoxumabs er 7,33 l (CV: 16 %).
English: ATC code: J06BB21
Icelandic: J06BB21
English: Your dose will be calculated using your body weight.
Icelandic: Skammturinn er reiknaður út frá líkamsþyngd þinni.
English: Among the 976/1554 (62 %) patients who had a positive baseline stool culture for C. difficile a hypervirulent strain (ribotypes 027, 078 or 244) was isolated in 22 % (217 of 976 patients), of which the majority (87 %, 189 of 217 strains) were ribotype 027.
Icelandic: Hjá 976/1.554 (62 %) sjúklinga sem voru með jákvæða C. difficile ræktun í hægðum í upphafi var mjög meinvirkur stofn (ribogerðir 027, 078 eða 244) einangraður hjá 22 % (217 af 976 sjúklingum) þar sem meirihlutinn (87 %, 189 af 217 stofnum) var af ribogerð 027.
English: Lonza Biologics Inc. 101 International Drive Portsmouth
Icelandic: 101 International Drive Portsmouth
English: Children and adolescents ZINPLAVA should not be used in children and adolescents below 18 years of age.
Icelandic: ZINPLAVA á ekki að nota hjá börnum og unglingum yngri en 18 ára.
English: • Do not freeze the diluted solution.
Icelandic: Ekki má frysta þynntu lausnina.
English: Immunogenicity of ZINPLAVA was evaluated using an electrochemiluminescence (ECL) assay in MODIFY I and MODIFY II.
Icelandic: Ónæmismyndun ZINPLAVA var metin með rafefnaljómsgreiningu (ECL, electrochemiluminescence) í MODIFY I og MODIFY II.
English: Do not use the vial if the solution is discoloured or contains visible particles.
Icelandic: Ekki á að nota hettuglasið ef lausnin er mislituð eða hún inniheldur sjáanlegar agnir.
English: Of the total 28 % had one or more episodes of CDI within the six months prior to the episode under treatment (18 % of the patients had one, 7 % had two and a few patients had 3 or more prior episodes).
Icelandic: Alls voru 28% með eitt eða fleiri tilvik Clostridium difficile sýkingar á innan við 6 mánuðum fyrir tilvikið sem verið var að meðhöndla (18 % sjúklinga voru með eitt og 7 % voru með tvö og nokkrir sjúklingar höfðu 3 eða fleiri fyrri tilvik).
English: The toxin B epitope to which bezlotoxumab binds is conserved, though not identical, across all known toxin sequences.
Icelandic: Vakaeiningin á toxíni B, sem bezlotoxumab binst við, er varðveitt, þó ekki nákvæmlega eins, í öllum toxínröðum sem þekktar eru.
English: The safety profile of ZINPLAVA was assessed in two Phase 3 clinical studies.
Icelandic: Öryggi ZINPLAVA var metið í tveimur 3. stigs klínískum rannsóknum.
English: You should not be given ZINPLAVA if:
Icelandic: Ekki má nota ZINPLAVA:
English: Overall, 51 % were ≥ 65 years, 29% were ≥ 75 years and 39 % received one or more systemic antibacterial agents during the 12 week follow-up period.
Icelandic: Í heildina var 51 % ≥ 65 ára, 29 % voru ≥ 75 ára og 39 % fengu eitt eða fleiri sýklalyf með altæka verkun meðan á 12 vikna eftirfylgnitímabilinu stóð.
English: In clinical trials, healthy subjects received up to 20 mg/kg, which was generally well tolerated.
Icelandic: Í klínískum rannsóknum fengu heilbrigðir þátttakendur allt að 20 mg/kg sem þoldist yfirleitt vel.