FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be transitioned to oral P2Y12 therapy for chronic treatment.
Danish: Ved kronisk behandling skal patienter overføres til oral P2Y12-behandling.
English: Any GUSTO bleeding
Danish: Enhver GUSTO-blødning
English: Reconstitute each 50 mg/vial by adding 5 mL of sterile water for injection.
Danish: Hvert 50 mg/hætteglas rekonstitueres ved tilsætning af 5 ml sterilt vand til injektion.
English: Metabolism of cangrelor is not dependent on CYPs and CYP isoenzymes are not inhibited by therapeutic concentrations of cangrelor or its major metabolites.
Danish: Cangrelors metabolisme afhænger ikke af CYP, og CYP-isoenzymer hæmmes ikke af cangrelors eller dettes vigtigste metabolitters terapeutiske koncentrationer.
English: Patients with coronary atherosclerosis were included who required PCI for stable angina (58%), non-ST-segment elevation acute coronary syndrome (NSTE-ACS) (26%), or ST-elevation myocardial infraction (STEMI) (16%).
Danish: Der inkluderedes patienter med koronar aterosklerose, som krævede PCI mod stabil angina (58 %), akut koronart syndrom uden STelevationer (NSTE-AKS) (26 %) eller myokardieinfarkt med ST-elevation (STEMI) (16 %).
English: Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC25.
Danish: Farmakoterapeutisk klassifikation: Blodplade-aggregationshæmmere excl. heparin, ATC-kode: B01AC25.
English: Dyspnoea (dyspnoea exertional)
Danish: Dyspnø (funktionsdyspnø)
English: Cangrelor did not produce malformations in either the rat or rabbit reproductive studies.
Danish: Cangrelor fremkaldte ingen misdannelser i reproduktionsstudier med hverken rotter eller kaniner.
English: A pharmacodynamic interaction study has also been conducted with cangrelor and ticagrelor.
Danish: Der er også gennemført et farmakodynamisk interaktionsstudie med cangrelor og ticagrelor.
English: Cangrelor produced dose-related foetal growth retardation characterised by increased incidences of incomplete ossification and unossified hind limb metatarsals in rats.
Danish: Cangrelor fremkaldte dosisrelateret væksthæmning hos fostre kendetegnet ved øgede forekomster af ufuldstændig ossifikation og ikke-ossificerede metatarsi i baglemmerne hos rotter.
English: Cangrelor should be used with caution in patients with disease states associated with an increased bleeding risk.
Danish: Cangrelor skal bruges med forsigtighed til patienter med sygdomstilstande associeret med øget blødningsrisiko.
English: During this procedure you may have a stent inserted in your blood vessel to help to keep it open.
Danish: Du kan under denne procedure få indført et lille metalgitter (en stent) i pulsåren, der hjælper med at holde den åben.
English: Kengrexal is administered as a weight-based regimen consisting of an initial intravenous bolus followed by an intravenous infusion.
Danish: Kengrexal administreres som en vægtbaseret behandling, der består af en intravenøs startbolus efterfulgt af en intravenøs infusion.
English: The primary adverse effects of cangrelor in rats and dogs occurred in the upper urinary tract and consisted of injury to renal tubules, renal pelvis, and ureter.
Danish: Cangrelors primære bivirkninger hos rotter og hunde forekom i de øvre urinveje og bestod af skader på tubuli renalis, pelvis renalis og ureter.
English: Anaemia, thrombocytopenia
Danish: Anæmi, trombocytopeni
English: • bleeding in the eye, brain (including stroke), pelvis and lung,
Danish: • blødning i øjet, hjernen (herunder også hjerneblødning), hofterne og lungerne,
English: Allow any foam to settle.
Danish: Lad eventuelt skum forsvinde.
English: The metabolism of cangrelor is independent of organ function and does not interfere with other drugs metabolised by hepatic enzymes.
Danish: Cangrelors mekanisme er ikke afhængig af organfunktion og påvirker ikke andre lægemidler, der metaboliseres af hepatiske enzymer.
English: Kengrexal diminishes the clumping of platelets and so reduces the chance of a blood clot forming.
Danish: Kengrexal reducerer blodpladernes sammenklumpning og reducerer dermed dannelsen af blodpropper.
English: Anatomical changes correlated with increased plasma creatinine and urea, and increased albumin and blood cells in urine.
Danish: Anatomiske forandringer svarede til forhøjet plasmakreatinin og -urea samt forhøjet albumin og erytrocytter/leukocytter i urin.
English: Paediatric population Cangrelor has not been evaluated in a paediatric population (see sections 4.2 and 5.1).
Danish: Cangrelor er ikke blevet vurderet i en pædiatrisk population (se pkt.
English: In clinical studies, cangrelor has been co-administered with bivalirudin, low molecular weight heparin, fondaparinux, and GP IIb/IIIa inhibitors (abciximab, eptifibatide, tirofiban) with no apparent effect upon the pharmacokinetics or pharmacodynamics of cangrelor.
Danish: I kliniske studie er cangrelor blevet administreret samtidig med bivalirudin, lavmolekylært heparin, fondaparinux og GP IIb-/IIIa-hæmmere (abciximab, eptifibatid, tirofiban) uden nogen tilsyneladende virkning på cangrelors farmakokinetik eller farmakodynamik.
English: Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.
Danish: Kengrexal, der administreres samtidig med acetylsalicylsyre (ASA), er indiceret til reduktion af trombotiske kardiovaskulære hændelser hos voksne med koronar hjertesygdom, som får foretaget perkutan koronar intervention (PCI), og som ikke har fået en oral P2Y12-hæmmer før PCIproceduren, og hvor oral behandling med P2Y12-hæmmere ikke er mulig eller ønskelig.
English: Wound haemorrhage, vascular pseudoaneurysm
Danish: Sårblødning, vaskulær pseudoaneurisme
English: Kengrexal is available in packs of 10 vials.
Danish: Kengrexal fås i pakninger med 10 hætteglas.
English: When administered in the PCI setting, cangrelor was associated with a greater incidence of GUSTO mild bleeding compared with clopidogrel.
Danish: Når cangrelor blev administreret på PCI-baggrund, var det forbundet med større forekomst af let GUSTO-blødning sammenlignet med clopidogrel.
English: • Any history of stroke or transient ischaemic attack (TIA).
Danish: • Apopleksi og transitorisk iskæmisk attak (TIA) i anamnesen.
English: Diluted solution: From a microbiological point of view, unless the method of reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.
Danish: Fortyndet opløsning: Ud fra et mikrobiologisk synspunkt skal produktet anvendes straks, medmindre rekonstitutions-/fortyndingsmetoden udelukker risiko for mikrobiologisk kontaminering.
English: You have been prescribed Kengrexal because you have blocked blood vessels in your heart (coronary artery disease) and you need a procedure (called a percutaneous coronary intervention - PCI) to remove the blockage.
Danish: Du har fået ordineret Kengrexal, fordi du har forsnævrede kranspulsårer i hjertet (koronar hjertesygdom), og du skal have udført en procedure (PCI - perkutan koronar intervention) for at fjerne forsnævringen.
English: A reversible effect on fertility was observed in male rats treated with Kengrexal (see section 5.3).
Danish: Der blev observeret en reversibel virkning hos hanrotter, som blev behandlet med Kengrexal (se pkt.
English: A higher rate of serious cases of hypersensitivity were recorded with cangrelor (0.05%) than with control (0.007%).
Danish: Der er registreret en højere forekomst af overfølsomhed med cangrelor (0,05 %) end med kontrolpræparatet (0,007 %).
English: Key Secondary Endpoint
Danish: Vigtigste sekundære endepunkt
English: Kengrexal is for injection, followed by infusion (drip), into a vein.
Danish: Kengrexal er beregnet til injektion efterfulgt af infusion (drop) i en vene.
English: Most dyspnoea events were mild or moderate in severity and the median duration of dyspnoea was two hours in patients receiving cangrelor (see section 4.8).
Danish: De fleste tilfælde af dyspnø var milde eller moderate og varede i gennemsnit 2 timer hos patienter, som fik cangrelor (se pkt.
English: Alternatively, a loading dose of ticagrelor or prasugrel, but not clopidogrel, may be administered up to 30 minutes before the end of the infusion, see section 4.5.
Danish: Alternativt kan der administreres en belastningsdosis ticagrelor eller prasugrel, men ikke clopidogrel, op til 30 minutter, før infusionen er slut, se pkt.
English: Cangrelor should be used with caution in patients taking medicines that may increase the risk of bleeding.
Danish: Cangrelor skal bruges med forsigtighed til patienter, som tager medicin, der øger blødningsrisikoen.
English: Any unexplained fall in blood pressure or haematocrit should lead to the serious consideration of a haemorrhagic event and the cessation of cangrelor administration.
Danish: Ved ethvert uventet blodtryksfald eller fald i hæmatokritværdi bør man alvorligt overveje, om der er sket en blødningshændelse, og om administration af cangrelor bør seponeres.
English: Serious adverse reactions associated with cangrelor in patients with coronary artery disease include severe/life threatening bleeding and hypersensitivity.
Danish: Alvorlige bivirkninger i forbindelse med cangrelor hos patienter med koronar hjertesygdom omfatter alvorlig/livstruende blødning og overfølsomhed.
English: Kengrexal is not recommended during pregnancy.
Danish: Kengrexal bør ikke anvendes under graviditeten.
English: Pharmacokinetic/pharmacodynamic relationship(s)
Danish: Farmakokinetiske/farmakodynamiske forhold
English: Bivalirudin, low molecular weight heparin, fondaparinux, and GP IIb/IIIa inhibitors
Danish: Bivalirudin, lavmolekylært heparin, fondaparinux og GP IIb-/IIIa-hæmmere
English: Retroperitoneal haemorrhage,* peritoneal haematoma, gastrointestinal haemorrhage a
Danish: Retroperitoneal blødning,* peritonealt hæmatom, gastrointestinal blødninga
English: For storage conditions after reconstitution and dilution of the medicinal product see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution og fortynding af lægemidlet, se pkt.
English: In addition, a higher rate of GUSTO moderate bleeding was reported in the cangrelor group (6.7%) compared to clopidogrel (1.4%).
Danish: Desuden blev der rapporteret en højere forekomst af moderat blødning i cangrelorgruppen (6,7 %) end i clopidogrelgruppen (1,4 %).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS
English: Irrespective of dose, following cessation of the infusion, blood levels decrease rapidly and platelet function returns to normal within one hour.
Danish: Uanset dosis falder niveauet i blod hurtigt efter seponering af infusionen, og trombocytfunktionen vender tilbage til normalfunktionen i løbet af en time.
English: • bleeding leading to decreases in blood volume or red blood cell numbers,
Danish: • blødning, der medfører mindre blodvolumen eller færre røde blodlegemer,
English: Other medicines and Kengrexal
Danish: Brug af anden medicin sammen med Kengrexal
English: The bolus and infusion should be administered from the infusion solution.
Danish: Bolus og infusion skal administreres fra infusionsvæsken, opløsning.
English: From a microbiological point of view, unless the method of reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal produktet anvendes straks, medmindre rekonstitutions/fortyndingsmetoden udelukker risikoen for mikrobiologisk kontaminering.
English: In the pooled safety population from the CHAMPION trials, the incidence of fatal bleeding within 30 days of dosing was low and similar in patients who received cangrelor compared to clopidogrel (8 [0.1%] vs. 9 [0.1%]).
Danish: I den sammenlagte sikkerhedspopulation fra CHAMPION-studierne var forekomsten af letal blødning inden for 30 dage efter dosering lav og svarende til forekomsten hos patienter, som fik cangrelor sammenlignet med clopidogrel (8 [0,1 %] vs. 9 [0,1 %]).
English: Each vial contains cangrelor tetrasodium corresponding to 50 mg cangrelor.
Danish: Hvert hætteglas indeholder cangrelor tetranatrium svarende til 50 mg cangrelor.
English: Contents of the pack and other information What Kengrexal contains
Danish: Pakningsstørrelser og yderligere oplysninger Kengrexal indeholder:
English: No dose adjustment is needed in patients with mild, moderate or severe renal insufficiency (see sections 4.4 and 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let, moderat eller svært nedsat nyrefunktion (se pkt.
English: In pivotal studies conducted in patients undergoing PCI, GUSTO (Global Use of Strategies to Open Occluded Arteries), moderate and mild bleeding events were more common in patients treated with cangrelor than in patients treated with clopidogrel, see section 4.8.
Danish: I pivotale studier med patienter, som gennemgik PCI, GUSTO (Global Use of Strategies to Open Occluded Arteries), forekom moderate og milde blødningshændelser hyppigere hos patienter, som blev behandlet med cangrelor, end hos patienter, som blev behandlet med clopidogrel, se pkt.
English: Reconstituted solution: the powder should be reconstituted immediately prior to dilution and use.
Danish: Rekonstitueret opløsning: Pulveret skal rekonstitueres straks inden fortynding og anvendelse.
English: When clopidogrel is administered during infusion of cangrelor, the expected inhibitory effect of clopidogrel on platelets is not achieved.
Danish: Når clopidogrel administreres under infusion af cangrelor, udebliver clopidogrels forventede hæmmende effekt på trombocytter.
English: The recommended dose of Kengrexal for patients undergoing PCI is a 30 micrograms/kg intravenous bolus followed immediately by 4 micrograms/kg/min intravenous infusion.
Danish: Den anbefalede dosis Kengrexal til patienter, som får PCI, er en 30 mikrogram/kg intravenøs bolus straks efterfulgt af 4 mikrogram/kg/min.
English: Impairment of fertility
Danish: Nedsat fertilitet
English: For transition, a loading dose of oral P2Y12 therapy (clopidogrel, ticagrelor or prasugrel) should be administered immediately following discontinuation of cangrelor infusion.
Danish: Der skal gives en belastningsdosis oral P2Y12-behandling (clopidogrel, ticagrelor eller prasugrel) straks efter seponering af cangrelorinfusionen.
English: Kengrexal 50 mg powder for concentrate cangrelor
Danish: Kengrexal 50 mg pulver til koncentrat cangrelor
English: Thrombotic events at 48 hours in CHAMPION PHOENIX (mITT population) Cangrelor vs. Clopidogrel n (%)
Danish: Tabel 3: Trombotiske hændelser efter 48 timer i CHAMPION PHOENIX (mITT-population) Cangrelor vs. Clopidogrel n (%)
English: In patients undergoing PCI, standard procedural adjunctive therapy should be implemented (see section 5.1).
Danish: Anvendelse med andre trombocytfunktionshæmmere Hos patienter, som gennemgår PCI, skal den supplerende standardbehandling før proceduren omfatte aspirin (se pkt 5.1).
English: - If you have any further questions, ask your doctor.
Danish: - Spørg lægen, hvis der er mere, du vil vide.
English: Thrombotic events at 30 days in CHAMPION PHOENIX (mITT population) Cangrelor vs. Clopidogrel n (%)
Danish: Tabel 4: Trombotiske hændelser efter 30 dage i CHAMPION PHOENIX (mITT-population) Cangrelor vs. Clopidogrel n (%)
English: Cangrelor exhibits inhibition of activation and aggregation of platelets as shown by aggregometry (light transmission and impedance), point-of care assays, such as the VerifyNow P2Y12test, VASP-P and flow cytometry.
Danish: Cangrelor udviser hæmning af aktivering og aggregation af trombocytter påvist ved aggregometri (lystransmission og -impedans), point-of-care-analyser, som f.eks. VerifyNow P2Y12-test, VASP-P og flowcytometri.
English: Irrespective of dose, following cessation of the infusion, cangrelor blood levels decrease rapidly and platelet function returns to normal within one hour.
Danish: Uanset dosis falder cangrelorniveauet i blod hurtigt efter seponering af infusionen, og trombocytfunktionen vender tilbage til normalfunktionen i løbet af en time.
English: Death
Danish: Dødsfald
English: Kengrexal contains cangrelor, a direct P2Y12 platelet receptor antagonist that blocks adenosine diphosphate (ADP)-induced platelet activation and aggregation in vitro and ex vivo.
Danish: Kengrexal indeholder cangrelor, en direkte P2Y12-trombocytreceptorantagonist, der blokerer ADPinduceret (adenosindiphosphat) trombocytaktivering og -aggregation in vitro og ex vivo.
English: Upper gastrointestinal haemorrhage, mouth haemorrhage, gingival bleeding, oesophageal haemorrhage, duodenal ulcer haemorrhage, haematemesis, lower gastrointestinal haemorrhage, rectal haemorrhage, haemorrhoidal haemorrhage, haematochezia.
Danish: Øvre gastrointestinal blødning, blødning i mund, blødning i tandkød, oesophagus-blødning, blødning i ulcus duodeni, hæmatemese, nedre gastrointestinal blødning, rektal blødning, hæmorideblødning, nedre gastrointestinal blødning.
English: • heavy menstrual bleeding,
Danish: • kraftig menstruation,
English: Excipient with known effect Each vial contains 52.2 mg sorbitol.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas indeholder 52,2 mg sorbitol.
English: CABG: Coronary Artery Bypass Graft Surgery; GUSTO: Global Use of Strategies to Open Coronary Arteries; w/o: without a In the CHAMPION pooled analysis, GUSTO Mild was defined as other bleed not requiring blood transfusion or causing haemodynamic compromise.
Danish: Enhver GUSTO-blødning Alvorlig/livstruende Moderat Mildb Mild u/ekkymose, udsivning og hæmatom <5 cm Patienter med enhver transfusion CABG: Koronar bypasskirurgi, GUSTO: Global Use of Strategies to Open Coronary Arteries (Global anvendelse af strategier til åbne koronararterier); u/: uden a I den sammenlagte CHAMPION-analyse blev GUSTO Mild defineret som anden blødning, der ikke kræver blodtransfusion eller forårsager hæmodynamisk kompromis.
English: Haematoma <5 cm, haemorrhage
Danish: Hæmatom <5 cm, blødning
English: In pivotal studies conducted in patients undergoing PCI dyspnoea (including exertional dyspnoea) occurred more commonly in patients treated with cangrelor (1.3%) than clopidogrel (0.4%).
Danish: I pivotale studier med patienter, som gennemgik PCI, forekom dyspnø (herunder funktionsdyspnø) hyppigere hos patienter, som blev behandlet med cangrelor (1,3 %) end med clopidogrel (0,4 %).
English: Onset of P2Y12 inhibition occurs rapidly upon cangrelor administration.
Danish: P2Y12-hæmning starter hurtigt efter administration af cangrelor.
English: The mean steady state concentration of cangrelor during a constant intravenous infusion of 4 micrograms/kg/min is 488 ng/mL.
Danish: Cangrelors gennemsnitlige steady state-koncentration under en konstant intravenøs infusion ved 4 mikrogram/kg/min.
English: In pivotal studies conducted in patients undergoing PCI, there were more intracranial bleeds at 30 days with cangrelor (0.07%) than with clopidogrel (0.02%), of which 4 bleeds with cangrelor and 1 bleed with clopidogrel were fatal.
Danish: I centrale studier med patienter, som gennemgik PCI, var der flere intrakranielle blødninger efter 30 dage med cangrelor (0,07 %) end med clopidogrel (0,02 %), hvoraf 4 blødninger ved cangrelor og 1 blødning ved clopidogrel var letale.
English: The powder should be reconstituted immediately prior to dilution and use.
Danish: Pulveret skal rekonstitueres straks inden fortynding og anvendelse.
English: • fluid discharge from injection or catheter sites.
Danish: • væske fra injektions- eller kateterstedet.
English: Hepatic impairment No dose adjustment is needed (see section 5.2).
Danish: Dosisjustering er ikke nødvendig (se pkt.
English: Kengrexal is an anti-platelet medicine that contains the active substance cangrelor.
Danish: Kengrexal er et lægemiddel, der hæmmer blodpladernes funktion (trombocytfunktionshæmmende medicin), og indeholder det aktive stof cangrelor.
English: • Periodic safety update reports (PSURs)
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Intracranial haemorrhage
Danish: Intrakraniel blødning
English: Sodium
Danish: Natrium
English: • reduced clotting of the blood,
Danish: • nedsat blodstørkning,
English: Neoplasms benign, malignant and unspecified (includes cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: For example, if you have a medical condition that affects blood clotting or because of another medical condition that may increase the risk of bleeding such as a recent serious injury, any recent surgery, history of a stroke or a transient ischaemic attack or recent bleeding from your stomach or gut.
Danish: • du har eller kan have en forøget risiko for blødning, hvis du f.eks. har en medicinsk tilstand, der påvirker blodets størkningsevne (koagulation) eller en anden medicinsk tilstand, der kan øge risikoen for blødning, såsom en nylig alvorlig skade, nylig operation, tidligere hjerneblødning eller blodprop i hjernen eller nylig blødning i maven eller tarmene.
English: • Bleeding leading to fluid around the heart, blood in the chest cavity or bleeding from the nose,
Danish: • Blødning, væske omkring hjertet, blod i brysthulen eller næseblod, blødning i mave-tarm kanalen, i maven eller i urinen eller fra injektions- eller kateterstedet,
English: • Bleeding leading to low platelet count or anaemia,
Danish: • Blødning, der medfører færre blodplader eller anæmi,
English: In pivotal studies conducted in patients undergoing PCI, there were more cardiac tamponades at 30 days with cangrelor (0.12%) than with clopidogrel (0.02%), (see section 4.8).
Danish: I pivotale studier med patienter, som gennemgik PCI, var der flere hjertetamponader efter 30 dage med cangrelor (0,12 %) end med clopidogrel (0,02 %)(se pkt.
English: After reconstitution 1 mL of concentrate contains 10 mg cangrelor and after dilution 1 mL of solution contains 200 micrograms cangrelor.
Danish: Efter rekonstitution indeholder 1 ml koncentrat 10 mg cangrelor, og efter fortynding indeholder 1 ml opløsning 200 mikrogram cangrelor.
English: • bleeding from the site of wounds,
Danish: • blødning fra sår,
English: Cangrelor is contraindicated in patients with any history of stroke/TIA, (see sections 4.3 and 4.8).
Danish: Cangrelor er kontraindiceret til patienter med apopleksi/TIA i anamnesen (se pkt.
English: If you use more Kengrexal than you should
Danish: Hvis du har fået for meget Kengrexal
English: In pivotal studies conducted in patients undergoing PCI, events of acute renal failure (0.1%), renal failure (0.1%) and increased serum creatinine (0.2%) were reported to occur after administration of cangrelor in clinical trials (see section 4.8).
Danish: I pivotale studier med patienter, som gennemgik PCI, blev der i kliniske afprøvninger rapporteret om hændelser med akut nyresvigt (0,1 %), nyresvigt (0,1 %) og øget serumkreatinin (0,2 %) efter administration af cangrelor (se pkt.
English: Powder for concentrate for solution for injection/infusion in a glass vial.
Danish: Pulver til koncentrat til injektions-/infusionsvæske, opløsning, i et hætteglas af glas.
English: How to use Kengrexal
Danish: Sådan får du Kengrexal
English: Haemorrhage intracranial d *
Danish: Intrakraniel blødningd *
English: Periorbital haematoma, subcutaneous haematoma
Danish: Periorbitalt hæmatom, subkutant hæmatom
English: Haematuria, blood urine present, urethral haemorrhage.
Danish: Hæmaturi, blod i urin, blødning i urethra.
English: Each vial contains 50 mg cangrelor.
Danish: Hvert hætteglas indeholder 50,0 mg cangrelor.
English: Treatment with Kengrexal may increase the risk of dyspnoea.
Danish: Behandling med Kengrexal kan øge risikoen for dyspnø.
English: White to off-white lyophilised powder.
Danish: Pulver til koncentrat til injektions-/infusionsvæske, opløsning Hvidt til offwhite frysetørret pulver.