FrancophonIA/ELRC3.0 huggingface dataset:
English: Enoxaparin sodium compared to unfractionated heparin significantly decreased the incidence of the primary end point, a composite of death from any cause or myocardial re-infarction in the first 30 days after randomization [9.9 percent in the enoxaparin sodium group, as compared with 12.0 percent in the unfractionated heparin group] with a 17 percent relative risk reduction (p < 0.001).
Danish: Ved sammenligning af enoxaparinnatrium og ufraktioneret heparin reducerede enoxaparinnatrium signifikant forekomsten af det primære effektmål, der var sammensat af død uanset årsag eller nyt myokardieinfarkt inden for de første 30 dage efter randomisering [9,9 % i enoxaparinnatrium-gruppen sammenlignet med 12,0 % i gruppen, der fik ufraktioneret heparin] med 17 % relativ risikoreduktion (p < 0,001).
English: Inhixa 15,000 IU (150 mg)/ mL
Danish: Inhixa 15.000 IE (150 mg)/ml
English: Do not mix with other medicinal products.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler.
English: There have been cases of neuraxial haematomas reported with the concurrent use of enoxaparin sodium and spinal/epidural anaesthesia or spinal puncture procedures resulting in long term or permanent paralysis.
Danish: I forbindelse med samtidig brug af enoxaparinnatrium og spinal/epidural anæstesi eller spinalpunktur er der set tilfælde af neuraksialt hæmatom, som resultererede i langvarig eller permanent paralyse.
English: Each mL contains 150 mg enoxaparin sodium.
Danish: Hver ml indeholder 150 mg enoxaparinnatrium.
English: For patients with creatinine clearance [15-30] mL/min, consider doubling the timing of puncture/catheter placement or removal to at least 24 hours.
Danish: Hos patienter med kreatininclearance 15-30 ml/min bør det overvejes at fordoble tiden til punktur/anlæggelse eller fjernelse af kateter til mindst 24 timer.
English: - Check your abdomen to see if the last injection caused any redness, change in skin colour, swelling,
Danish: - Undersøg huden på din mave for at se, om den sidste indsprøjtning har forårsaget rødme,
English: Inhixa.
Danish: drop.
English: Push hard the plunger.
Danish: Tryk stadig på stemplet!
English: (1 mg/kg) administered subcutaneously every 12 hours (maximum 10,000 IU (100 mg) for each of the first two subcutaneous doses).
Danish: 100 IE/kg (1 mg/kg) subkutant hver 12. time (højst 10.000 IE (100 mg) ved hver af de første to subkutane doser).
English: In a double blind multicentre, parallel group study, enoxaparin sodium 2,000 IU (20 mg) or 4,000 IU (40 mg) once a day subcutaneously was compared to placebo in the prophylaxis of DVT in medical patients with severely restricted mobility during acute illness (defined as walking distance of < 10 meters for ≤ 3 days).
Danish: I et dobbeltblindt multicenterstudie med parallelle grupper blev enoxaparinnatrium 2.000 IE (20 mg) eller 4.000 IE (40 mg) subkutant en gang dagligt sammenlignet med placebo til profylakse mod DVT hos medicinske patienter med svært begrænset mobilitet under akut sygdom (defineret som gådistance <10 meter i ≤3 dage).
English: The complete contents of the 6,000 IU (60 mg) enoxaparin sodium pre-filled syringe should be injected into the 20 mL remaining in the bag.
Danish: Hele indholdet af den fyldte injektionssprøjte med 6.000 IE (60 mg) enoxaparinnatrium injiceres i de 20 ml, der er tilbage i posen.
English: • Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism.
Danish: • Profylakse af venøs tromboembolisk sygdom hos medicinske patienter med akut sygdom (såsom akut hjertesvigt, respirationssvigt, svære infektioner eller reumatiske sygdomme) og nedsat mobilitet med øget risiko for venøs tromboemboli.
English: The mean maximum anti-IIa activity level is observed approximately 3 to 4 hours following subcutaneous injection and reaches 0.13 IU/mL and 0.19 IU/mL following repeated administration of 100 IU/kg (1 mg/kg) twice daily and 150 IU/kg (1.5 mg/kg) once daily, respectively.
Danish: Den gennemsnitlige maksimale anti-IIa-aktivitet i plasma ses ca. 3 til 4 timer efter subkutan injektion og når 0,13 IE/ml og 0,19 IE/ml efter gentagen administration af henholdsvis 100 IE/kg (1 mg/kg) to gange dagligt og 150 IE/kg (1,5 mg/kg) en gang dagligt.
English: • In patients with renal impairment, there is an increase in exposure of enoxaparin sodium which increases the risk of bleeding.
Danish: • Eksponeringen for enoxaparinnatrium er øget hos patienter med nedsat nyrefunktion, hvilket øger risikoen for blødning.
English: Inhixa 50,000 IU (500 mg)/5 mL
Danish: Inhixa 50.000 IE (500 mg)/5 ml
English: The 3,000 IU (30 mg) dose can then be directly injected into the IV line.
Danish: 3.000 IE (30 mg) dosen kan injiceres direkte i i.v.
English: Solution for injection in multidose vial 5 vials
Danish: Injektionsvæske, opløsning i flerdosis hætteglas 5 hætteglas
English: Inhixa 4,000 IU (40 mg)/0.4 mL
Danish: Inhixa 4.000 IE (40 mg)/0,4 ml
English: • Proximal DVT (%) *p value versus placebo =0.008 #p value versus placebo =0.537
Danish: DVT (%) *p-værdi versus placebo =0,008 #p-værdi versus placebo =0,537
English: • Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism (VTE).
Danish: • Profylakse af venøs tromboembolisk sygdom hos medicinske patienter med akut sygdom (såsom akut hjertesvigt, respirationssvigt, svære infektioner eller reumatiske sygdomme) og nedsat mobilitet med øget risiko for venøs tromboemboli (VTE).
English: • you are currently using medicines which affect bleeding (see section “Other medicines”).
Danish: • hvis du bruger medicin, der påvirker blodets evne til at størkne (se nedenstående afsnit ”Brug af anden medicin sammen med Inhixa”).
English: 9) Drop the used syringe into the sharps container.
Danish: 9) Læg den brugte sprøjte ned i en beholder til skarpe genstande.
English: When non-weight adjusted dosing was administered, it was found after a single-subcutaneous 4,000 IU (40 mg) dose, that anti-Xa exposure is 52% higher in low-weight women (< 45 kg) and 27% higher in low-weight men (< 57 kg) when compared to normal weight control subjects (see section 4.4).
Danish: Ved administration af ikke-vægtjusterede doser fandt man, at efter en enkelt subkutan dosis på 4.000 IE (40 mg) var eksponeringen for anti-Xa 52 % højere hos kvinder med lav vægt (<45 kg) og 27 % højere hos mænd med lav vægt (<57 kg) sammenlignet med normalvægtige kontrolpersoner (se pkt.
English: • Spinal/Epidural anaesthesia or lumbar puncture
Danish: • Spinal/epidural anæstesi eller lumbalpunktur
English: For intravenous injection, either the multidose vial or pre-filled syringe can be used.
Danish: Til intravenøs injektion anvendes enten flerdosishætteglas eller fyldt injektionssprøjte.
English: • you have kidney problems
Danish: • hvis du har nyreproblemer
English: How to use Inhixa
Danish: Sådan skal du bruge Inhixa
English: Spinal/Epidural anaesthesia or lumbar puncture
Danish: Spinal/epidural anæstesi eller lumbalpunktur
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE PAKNING, FLERDOSIS HÆTTEGLAS
English: 10) Drop the used syringe into the sharps container.
Danish: 10) Læg den brugte sprøjte ned i en beholder til skarpe genstande.
English: Switch between enoxaparin sodium and oral anticoagulants Switch between enoxaparin sodium and vitamin K antagonists (VKA) Clinical monitoring and laboratory tests [prothrombin time expressed as the International Normalized Ratio (INR)] must be intensified to monitor the effect of VKA.
Danish: Skift mellem enoxaparinnatrium og orale antikoagulantia Skift mellem enoxaparinnatrium og vitamin K-antagonister (VKA) Klinisk monitorering og laboratorieprøver [protrombintid udtrykt som International Normaliseret Ratio (INR)] skal intensiveres for at monitorere virkningen af VKA.
English: Inhixa 6,000 IU (60 mg)/0.6 mL
Danish: Inhixa 6.000 IE (60 mg)/0,6 ml
English: The rate of the 30 day composite endpoint of death, myocardial re-infarction or intracranial haemorrhage (a measure of net clinical benefit) was significantly lower (p < 0.0001) in the enoxaparin sodium group (10.1%) as compared to the heparin group (12.2%), representing a 17% relative risk reduction in favour of treatment with enoxaparin sodium.
Danish: Hyppigheden af det sammensatte effektmål død, nyt myokardieinfarkt eller intrakraniel blødning i løbet af 30 dage (mål for netto klinisk fordel) var signifikant lavere (p < 0,0001) i enoxaparinnatriumgruppen (10,1 %) sammenlignet med heparin-gruppen (12,2 %) (reduktion på 17 % af den relative risiko til fordel for enoxaparinnatrium).
English: If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4).
Danish: Hvis der er planlagt epidural anæstesi, anbefales det at seponere behandlingen med enoxaparinnatrium før anæstesien (se pkt.
English: Caution should be used in patients with hepatic impairment as these patients have an increased potential for bleeding (see section 4.4) and no formal dose finding studies have been performed in cirrhotic patients (Child Pugh class A, B nor C).
Danish: 4.4), og der er ikke udført formelle studier hos patienter med cirrose til at fastlægge dosis (ChildPugh klasse A, B eller C).
English: Administration in spinal/epidural anaesthesia or lumbar puncture
Danish: Administration ved spinal-/epidural anæstesi eller lumbalpunktur
English: 30 pre-filled syringes
Danish: 30 fyldte sprøjter
English: In the in vitro purified system, enoxaparin sodium has a high anti-Xa activity (approximately 100 IU/mg) and low anti-IIa or anti thrombin activity (approximately 28 IU/mg), with a ratio of 3.6.
Danish: I det in vitro-oprensede system har enoxaparinnatrium en høj anti-Xa-aktivitet (cirka 100 IE/mg) og en lav anti-IIa- eller antitrombin-aktivitet (cirka 28 IE/mg) med en ratio på 3,6.
English: Inhixa 8,000 IU (80 mg)/0.8 mL
Danish: Inhixa 8.000 IE (80 mg)/0,8 ml
English: These included 1,776 for prophylaxis of deep vein thrombosis following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of deep vein thrombosis in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI.
Danish: Studierne inkluderede 1.776 patienter med risiko for tromboemboliske komplikationer, der fik enoxaparinnatrium profylaktisk mod dyb venetrombose efter ortopædisk eller abdominal operation, 1.169 akut syge medicinske patienter med svært nedsat mobilitet, der fik enoxaparinnatrium profylaktisk mod dyb venetrombose, 559 patienter, der fik enoxaparinnatrium behandling af DVT med eller uden lungeemboli, 1.578 patienter, der fik enoxaparinnatrium til behandling af ustabil angina pectoris eller myokardieinfarkt uden Q-taksudvikling, og 10.176 patienter, der fik enoxaparinnatrium til behandling af akut STEMI.
English: Enoxaparin sodium can be administered subcutaneously either as a once daily injection of 150 IU/kg (1.5 mg/kg) or as twice daily injections of 100 IU/kg (1 mg/kg).
Danish: Enoxaparinnatrium kan administreres subkutant enten som 150 IE/kg (1,5 mg/kg) en gang dagligt eller 100 IE/kg (1 mg/kg) to gange dagligt.
English: Arterial line injection
Danish: Injektion i arterieslangen
English: België/Belgique/Belgien TD Pharma B.V.
Danish: België/Belgique/Belgien
English: - The other ingredients are benzyl alcohol (see section 2) and water for injections.
Danish: - Øvrige indholdsstoffer: benzylalkohol (se pkt.
English: 50 pre-filled syringes
Danish: 50 fyldte sprøjter
English: • For acute STEMI, treatment is to be initiated with a single intravenous bolus injection immediately followed by a subcutaneous injection.
Danish: • Ved akut STEMI skal behandlingen indledes med en enkelt intravenøs bolus injektion, umiddelbart efterfulgt af en subkutan injektion.
English: For patients being managed with PCI, an additional intravenous bolus of 30 IU/kg (0.3 mg/kg) is to be administered if last subcutaneous administration was given more than 8 hours before balloon inflation.
Danish: Patienter, der får foretaget PCI, skal have en yderligere intravenøs bolus injektion på 30 IE/kg (0,3 mg/kg) enoxaparinnatrium, hvis den sidste subkutane dosis blev givet mere end 8 timer før ballonudvidelsen.
English: Enoxaparin sodium is to be used with extreme caution in patients with a history (> 100 days) of heparin-induced thrombocytopenia without circulating antibodies.
Danish: Enoxaparinnatrium skal anvendes med ekstrem forsigtighed hos patienter med heparininduceret trombocytopeni i anamnesen (>100 dage) uden cirkulerende antistoffer.
English: The safety and efficacy of enoxaparin sodium in children have not been established (see section 4.2).
Danish: Enoxaparinnatriums sikkerhed og virkning hos børn er ikke klarlagt (se pkt.
English: • Percutaneous coronary revascularization procedures
Danish: • Perkutan koronar revaskulasisering
English: The enoxaparin sodium dose was 4,000 IU (40 mg) subcutaneously once daily for prophylaxis of deep vein thrombosis following surgery or in acutely ill medical patients with severely restricted mobility.
Danish: Dosis var 4.000 IE (40 mg) enoxaparinnatrium subkutant en gang dagligt som profylaktisk behandling af DVT efter kirurgi og hos akut syge medicinske patienter med svært nedsat mobilitet.
English: In the clinical studies for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) subcutaneously every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) intravenous bolus followed by 100 IU/kg (1 mg/kg) subcutaneously every 12 hours.
Danish: I det kliniske studie med behandling af ustabil angina pectoris og myokardieinfarkt uden Qtaksudvikling var dosis 100 IE/kg (1 mg/kg) subkutant hver 12. time, og i det kliniske studie til behandling af akut STEMI var doseringsregimet 3.000 IE (30 mg) enoxaparinnatrium som intravenøs bolus efterfulgt af 100 IE/kg (1 mg/kg) subkutant hver 12. time.
English: Inhixa 30,000 IU (300 mg)/3 mL
Danish: Inhixa 30.000 IE (300 mg)/3 ml.
English: Inhixa 100,000 IU (1000 mg)/10 mL
Danish: Inhixa 100.000 IE (1.000 mg)/10 ml
English: Medicinal products increasing potassium levels
Danish: • Lægemidler, der øger kaliumkoncentrationen
English: Intravenous administration of benzyl alcohol has been associated with serious adverse events and death in neonates (“Gasping Syndrome”) (see section 4.3).
Danish: Intravenøs administration af benzylalkohol blevet forbundet med alvorlige bivirkninger og død hos nyfødte (“snappende vejrtrækning”) (se pkt.
English: In moderate risk patients, enoxaparin sodium treatment should be maintained for a minimal period of 7-10 days whatever the recovery status (e.g. mobility).
Danish: Hos patienter med moderat risiko bør behandlingen med enoxaparinnatrium vare i mindst 7-10 dage uanset rekonvalescens-status (f.eks. mobilitet).
English: In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) subcutaneous dose every 12 hours or a 150 IU/kg (1.5 mg/kg) subcutaneous dose once a day.
Danish: Ved behandling af DVT med eller uden lungeemboli fik patienterne enten 100 IE/kg (1 mg/kg) enoxaparinnatrium subkutant hver 12. time eller 150 IE/kg (1,5 mg/kg) subkutant en gang dagligt.
English: 2 pre-filled syringes
Danish: 2 fyldte sprøjter
English: The use of a tuberculin syringe or equivalent is recommended when using ampoules or multiple-dose vials to assure withdrawal of the appropriate volume of drug.
Danish: For at sikre at den korrekte volumen lægemiddel trækkes op, anbefales det at anvende en tuberkulinsprøjte eller tilsvarende injektionssprøjte ved brug af ampul eller flerdosishætteglas.
English: Inhixa 12,000 IU (120 mg)/0.8 mL
Danish: Inhixa 12.000 IE (120 mg)/0,8 ml.
English: : such as haematoma, ecchymosis other than at injection site, wound haematoma, haematuria, epistaxis and gastro-intestinal haemorrhage.
Danish: : såsom hæmatom, ekkymoser andre steder end på injektionsstedet, sårhæmatom, hæmaturi, epistaxis og gastrointestinal blødning.
English: o Additional bolus for PCI when last SC administration was given more than 8 hours before balloon inflation For patients being managed with PCI, an additional IV bolus of 30 IU/kg (0.3 mg/kg) is to be administered if last SC administration was given more than 8 hours before balloon inflation.
Danish: o Yderligere bolus ved PCI, når sidste subkutane administration blev givet mere end 8 timer før ballonudvidelsen Patienter, der får foretaget PCI, skal have en yderligere intravenøs bolus injektion på 30 IE/kg(0,3 mg/kg) enoxaparinnatrium, hvis den sidste subkutane dosis blev givet mere end 8 timer førballonudvidelsen.
English: A puncture-free interval of at least 24 hours shall be kept between the last injection of enoxaparin sodium at curative doses and the needle or catheter placement (see also section 4.3).
Danish: Der skal være et punkturfrit interval på mindst 24 timer mellem den sidste injektion af enoxaparinnatrium i kurative doser og anlæggelse af kanyler eller kateter(se også pkt.
English: Dosage table for patients with severe renal impairment (creatinine clearance [15-30] mL/min):
Danish: Doseringstabel for patienter med svært nedsat nyrefunktion (kreatinclearance 15-30 ml/min):
English: The usual dose is 100 IU (1 mg) for every kilogram of your weight, every 12 hours.
Danish: Den sædvanlige dosis er 100 IE (1 mg) pr. kg legemsvægt hver 12. time.
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).
Danish: I kliniske studier var blødning, trombocytopeni og trombocytose de hyppigst rapporterede bivirkninger (se pkt.
English: Inhixa 2,000 IU (20 mg)/0.2 mL
Danish: Inhixa 2.000 IE (20 mg)/0,2 ml.
English: Inhixa 30,000 IU (300 mg)/3 mL solution for injection in multidose vial Inhixa 50,000 IU (500 mg)/5 mL solution for injection in multidose vial Inhixa 100,000 IU (1000 mg)/10 mL solution for injection in multidose vial enoxaparin sodium
Danish: Indlægsseddel: Information til brugeren Inhixa 30.000 IE (300 mg)/3 ml injektionsvæske, opløsning i flerdosishætteglas Inhixa 50.000 IE (500 mg)/5 ml injektionsvæske, opløsning i flerdosishætteglas Inhixa 100.000 IE (1000 mg)/10 ml injektionsvæske, opløsning i flerdosishætteglas Enoxaparinnatrium
English: Enoxaparin sodium should be administered through an IV line.
Danish: Enoxaparinnatrium bør administreres i et i.v.
English: Should the physician decide to administer anticoagulation in the context of epidural or spinal anaesthesia/analgesia or lumbar puncture, careful neurological monitoring is recommended due to the risk of neuraxial haematomas (see section 4.4).
Danish: - Hvis lægen beslutter at administrere et antikoagulans i forbindelse med epidural eller spinal anæstesi/analegsi eller lumbalpunktur, anbefales tæt neurologisk monitorering på grund af risikoen for neuraksialt hæmatom (se pkt.
English: There have been isolated post-marketing reports of valve thrombosis in pregnant women with mechanical prosthetic heart valves while receiving enoxaparin sodium for thromboprophylaxis.
Danish: Efter markedsføring har der været enkeltstående indberetninger vedrørende hjerteklaptromboser hos gravide kvinder med hjerteklapprotese, der fik enoxaparinnatrium som tromboseprofylakse.
English: Percutaneous coronary revascularization procedures
Danish: Perkutan koronar revaskulasisering
English: Enoxaparin sodium, as with any other anticoagulant therapy, should be used with caution in conditions with increased potential for bleeding, such as: - impaired haemostasis, - history of peptic ulcer, - recent ischemic stroke, - severe arterial hypertension, - recent diabetic retinopathy, - neuro- or ophthalmologic surgery, - concomitant use of medicinal products affecting haemostasis (see section 4.5).
Danish: I lighed med andre antikoagulantia bør enoxaparinnatrium anvendes med forsigtighed ved øget blødningsrisiko som f.eks.: - nedsat hæmostase, - mavesår i anamnesen, - nylig iskæmisk apopleksi, - svær arteriel hypertension, - nylig diabetisk retinopati, - neurokirurgi eller øjenoperation, - samtidig brug af lægemidler, der påvirker hæmostasen (se pkt.
English: Low weight
Danish: Nedsat leverfunktion
English: Volume to inject when diluted to a final concentration of 300 IU (3 mg)/mL
Danish: Volumen, der skal injiceres efter fortynding til en endelig koncentration på 300 IE (3 mg)/ml
English: Blood and lymphati c system disorders
Danish: Blod og lymfesyste m
English: Supplied in packs of 5 vials.
Danish: Fås i pakninger med: 5 hætteglas
English: Administration in spinal/epidural anaesthesia or lumbar puncture Should the physician decide to administer anticoagulation in the context of epidural or spinal anaesthesia/analgesia or lumbar puncture, careful neurological monitoring is recommended due to the risk of neuraxial haematomas (see section 4.4).
Danish: Administration ved spinal/epidural anæstesi eller lumbalpunktur Hvis lægen beslutter at administrere et antikoagulans i forbindelse med epidural eller spinal anæstesi/analgesi eller lumbalpunktur, anbefales tæt neurologisk monitorering på grund af risikoen for neuraksialt hæmatom (se pkt.
English: Because of the content of benzyl alcohol (see section 6.1), enoxaparin sodium multiple dose vial formulation must not be given to newborns or premature neonates (see sections 4.4 and 4.6).
Danish: 6.1) må enoxaparinnatrium i flerdosis hætteglas ikke gives til nyfødte eller for tidligt fødte nyfødte (se pkt.
English: • In moderate risk patients, enoxaparin sodium treatment should be maintained for a minimal period of 7-10 days whatever the recovery status (e.g. mobility).
Danish: • Hos patienter med moderat risiko bør behandlingen med enoxaparinnatrium vare i mindst 710 dage uanset rekonvalescens-status (f.eks. mobilitet).
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger på Det Europæiske Lægemiddelagenturs hjemmeside www.ema.europa.eu
English: Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, careful clinical monitoring is advised.
Danish: Selvom der ikke anbefales dosisjustering for patienter med moderat nedsat nyrefunktion (kreatininclearance 30-50 ml/min) og let nedsat nyrefunktion (kreatininclearance 50-80 ml/min), bør tilrådes omhyggelig klinisk monitorering.
English: Supplied in packs of 1 vial.
Danish: Fås i pakninger med: 1 hætteglas
English: Benzyl alcohol may also cause toxic reactions in infants and children up to 3 years old, due to increased risk of accumulation (see section 4.4).
Danish: Benzylalkohol kan også medføre toksiske reaktioner hos spædbørn og børn op til 3 år på grund af øget risiko for ophobning (se pkt.
English: Benzyl alcohol (75 mg in 5.0 mL)
Danish: Hjælpestof(fer) med kendt virkning Benzylalkohol (75 mg i 5,0 ml)
English: • Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids.
Danish: • Andre lægemidler, der påvirker hæmostasen, såsom: - Trombocytfunktionshæmmere, inklusive acetylsalicylsyre i antiaggregerende dosis (kardiobeskyttelse), clopidogrel, ticlopidin og glykoprotein IIb/IIIa-antagonister indiceret ved akut koronarsyndrom på grund af blødningsrisikoen, - Dextran 40, - Systemiske glukokortikoider.