FrancophonIA/ELRC3.0 huggingface dataset:
English: No adverse effects on fertility or general reproductive performance were noted in rats given IV Rienso at doses up to 18 mg Fe/kg/day (Human Equivalent Dose of 2.9 mg Fe/kg/day).
Danish: Der er ikke iagttaget nogen indvirkninger på fertilitet eller general reproduktionsevne hos rotter, der fik IV Rienso i doser på op til 18 mg Fe/kg/dag (Human ækvivalent dosis (HED) på 2,9 mg Fe/kg/dag).
English: The MAH shall conduct a PASS to further characterise the safety concerns on the hypersensitivity reactions.
Danish: Indehaveren af markedsføringstilladelsen skal udfører et PASS (studie) til nærmere karakterisering af sikkerhedsproblemerne ved hypersensitivitetsreaktioner.
English: - The active substance is iron as ferumoxytol 30 mg/ml.
Danish: - Aktivt stof: jern (som ferumoxytol 30 mg/ml).
English: Available pharmacokinetic data in animals have shown excretion of Rienso in milk (see section 5.3).
Danish: De tilgængelige farmakodynamiske data fra dyreforsøg viser, at Rienso udskilles i mælk (se pkt.
English: Injection site discolouration Injection site pruritus
Danish: Misfarvning på injektionsstedet Pruritus på injektionsstedet
English: Overdose • Overdose should be treated, if required with an iron chelating agent.
Danish: Overdosis • Overdosering skal behandles, om nødvendigt, med et jernkeleringsmiddel.
English: This medicinal product contains less than 23 mg sodium per 17 ml vial, i.e., is essentially “sodium free”.
Danish: Lægemidlet indeholder mindre end 23 mg natrium pr. 17 ml hætteglas, dvs. det er stort set ”natriumfrit”.
English: Administration of Rienso may transiently affect the diagnostic ability of MR imaging.
Danish: Administration af Rienso kan forbigående påvirke den diagnostiske evne ved MR-scanning.
English: 2 × 510 mg iron (2 vials)
Danish: 2 × 510 mg jern (2 hætteglas)
English: However, caution should be exercised in interpreting serum iron levels in the 24 hours following administration of Rienso as laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Rienso.
Danish: Dog skal der udvises forsigtighed med fortolkning af serum-jernniveauer i de 24 timer, der følger efter administrationen af Rienso, da laboratorieanalyser kan overvurdere serumjern og transferrinbundet jern ved at måle jernet i Rienso med. Se afsnit om jernoverskud i pkt.
English: In rabbits administration of Rienso during organogenesis induced decreased foetal weights and external and/or soft tissue malformations (malrotated or flexed fore- and malrotated hindlimbs, internal hydrocephaly, absent brains, cleft palate and microglossia) at the high dose of 45.3 mg Fe/kg/day (HED of 14.6 mg Fe/kg/day), a dose which induced only minimal maternal toxicity.
Danish: Hos kaniner medførte administration af Rienso under organogenesen nedsat føtal vægt samt deformering af ekstremiteter og/eller bløddele (fejlroterede eller flekterede for- og fejlroterede baglemmer, intern hydrocefalus, manglende hjerne, ganespalte og mikroglossi) i den høje dosis på 45,3 mg Fe/kg/dag (HED på 14,6 mg Fe/kg/dag).
English: Treatment Course
Danish: Behandlingsforløb
English: • Anaemia not caused by iron deficiency
Danish: • Tegn på jernoverskud • Anæmi, som ikke skyldes jernmangel
English: You must not receive Rienso: - if you are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Rienso: - hvis du er allergisk (overfølsom) over for det aktive stof eller et af de øvrige indholdsstoffer i
English: In a prenatal and postnatal developmental study in rats adverse effects on sexual maturation and on the ability to produce a litter were noted in the F1-generation (see section 5.3).
Danish: I et prænatalt og postnatalt udviklingsstudie på rotter sås utilsigtede bivirkninger på kønsmodning og reproduktionsevne i F1-generationen (se pkt.
English: Shelf-life after first opening and after dilution for infusion:
Danish: Opbevaringsbetingelser efter anbrud og fortynding til infusion:
English: Baseline at Day 35 (mean ± SD, %)
Danish: TSAT-ændring fra baseline på dag 35 (Mean ± SD, %)
English: Blood glucose decreased
Danish: Nedsat blodglucose
English: Tachycardia/Arrhythmia, Cardiac arrest Cardio-respiratory arrest Myocardial infarction Cyanosis
Danish: Takykardi/arytmi, Hjertestop Kardiorespiratorisk stop
English: - if you have severe asthma, eczema or other allergies.
Danish: - hvis du lider af astma, eksem eller andre allergier i alvorlig grad. - hvis du har leverproblemer
English: Rienso should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.
Danish: Rienso bør kun administreres, når et personale, der har erfaring med at vurdere og håndtere anafylaktiske reaktioner, er umiddelbart tilgængeligt og kun i et miljø, hvor der er adgang til komplet genoplivningsudstyr.
English: Other medicines and Rienso
Danish: Brug af anden medicin sammen med Rienso
English: Special population - patients receiving haemodialysis
Danish: Særlig population (patienter i hæmodialyse)
English: Clinical presentation has included anaphylactic type reactions presenting with cardiac arrest/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness (see section 4.8).
Danish: De kliniske manifestationer inkluderede anafylaktiske reaktioner, der viser sig ved hjertestop/kardiorespiratorisk stop, klinisk signifikant hypotension, synkope og manglende respons (se pkt.
English: Rienso should not be administered to patients with iron overload.
Danish: Rienso bør ikke administreres til patienter med jernoverskud.
English: Common side effects (may affect up to 1 in 10 people): - bleeding, swelling, bruising, pain, rash, irritation or warmth at infusion/injection site
Danish: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 patienter): - Blødning, hævelse, misfarvning, smerter, udslæt, irritation eller varme på infusions
English: P: +45 4677 1111 F: +45 4675 6640
Danish: T: +45 4677 1111 F: +45 4675 6640
English: Baseline at Day 35 (mean ± SD, ng/ml) * p≤0.001 for main efficacy endpoint
Danish: Ferritin-ændring fra baseline på dag 35 (Mean ± SD, ng/ml) * p≤0,001 for hovedeffektendepunkt
English: The vials are for single use only.
Danish: Hætteglassene er kun beregnet til engangsbrug.
English: Four case reports have been published describing the supraparamagnetic effects of ferumoxytol on MR imaging and emphasized the importance for the radiologists to be aware if a patient received ferumoxytol recently.
Danish: I denne PSUR er der fremlagt yderligere dokumentation af indehaveren af markedsføringstilladelsen, som identificerer 9 relevante publikationer, der handler om ferumoxytol og MR. Fire rapporter om tilfælde er blevet publiceret, som beskriver de supraparamagnetiske virkninger af ferumoxytol på MRbilleddannelse og understregede vigtigheden af, at radiologerne er opmærksomme på, om en patient nyligt har modtaget ferumoxytol.
English: • Hypersensitivity to the active substance, to Rienso or any of its excipients listed in section 6.1
Danish: • Overfølsomhed over for det aktive stof, over for Rienso eller over for et eller flere af hjælpestofferne anført i pkt.
English: RARE (≥ 1/10,000 to
Danish: SJÆLDEN (>1/10.000 til
English: Oral Iron n = 77
Danish: Oralt jern n = 77
English: Severe adverse reactions of clinically significant hypotension have been reported.
Danish: Klinisk signifikant hypotension er indberettet som alvorlig bivirkning.
English: Oral Iron n = 116
Danish: Oralt jern n = 116
English: If you are breast-feeding, ask your doctor for advice before you are given Rienso.
Danish: Hvis du ammer, skal du tale med lægen, før du får Rienso.
English: P: +45 4677 1111
Danish: T: +45 4677 1111
English: In Study 3, the mean age of patients was 60 years (range, 24 to 87); 43% were female; 34% were Caucasian, 59% were Black, and 7% were other races.
Danish: I Studie 3 var patienternes gennemsnitsalder 60 år (24-87 år); 43 % var kvinder; 34 % var kaukasere, 59 % var negroide, og 7 % var andre racer.
English: Pulse absent Oxygen saturation decreased
Danish: Manglende puls Nedsat iltmætning
English: In Study 2, the mean age of patients was 65 years (range, 31 to 96); 61% were female; 58% were Caucasian, 35% were Black, and 7% were other races.
Danish: I Studie 2 var patienternes gennemsnitsalder 65 år (31-96 år); 61 % var kvinder; 58 % var kaukasere, 35 % var negroide, og 7 % var andre racer.
English: The study will also have to be reflected in the updated RMP submission.
Danish: Dette forsøg skal også fremgå af den opdaterede risikostyringsplan.
English: Rienso should only be administered when staff trained to evaluate and manage anaphylactic reactions are immediately available.
Danish: Rienso må kun administreres, når der er personale trænet til at evaluere og håndtere tilfælde af anafylaktiske reaktioner.
English: The iron is then released intracellularly from the iron-carbohydrate complex within vesicles in macrophages.
Danish: Jernet frigives derefter intracellulært fra jernkulhydratkomplekset i makrofagernes vesikler.
English: Skin & subcutaneous tissue disorders
Danish: Hud og subkutane væv
English: In Study 1, the mean age of patients was 66 years (range, 23 to 95); 60% were female; 65% were Caucasian, 32% were Black, and 2% were other races.
Danish: I Studie 1 var patienternes gennemsnitsalder 66 år (23-95 år); 60 % var kvinder; 65 % var kaukasere, 32 % var negroide, og 2 % var andre racer.
English: 510 mg iron (1 vial)
Danish: 510 mg jern (1 hætteglas)
English: Oral Iron n = 76
Danish: Oralt jern n = 76
English: Study 3 CKD on Haemodialysis
Danish: Studie 3 CKD i hæmodialyse
English: Laryngeal oedema Pharyngeal oedema Respiratory arrest Respiratory failure Throat irritation Throat tightness Wheezing
Danish: Laryngealt ødem Faryngealt ødem Respiratorisk stop Respiratorisk svigt Svælg-irritation Sammensnøring af halsen
English: *Fatal and life-threatening hypersensitivity reactions have been observed with Rienso in the post marketing setting (see sections 4.3 and 4.4).
Danish: * Der er registreret dødelig og livstruende overfølsomhedreaktioner med Rienso efter markedsføring af produktet (se pkt.
English: Rienso should not be given to patients if their haemoglobin is greater than 12 g/dl, serum Transferrin Saturation (TSAT) is greater than 50% or Ferritin is greater than 800 ng/ml (see section 4.4).
Danish: Rienso bør ikke gives til patienter, hvis deres hæmoglobin er højere end 12 g/dl, serum transferrinmætning (TSAT) er højere end 50 % eller ferritin er højere end 800 ng/ml (se pkt.
English: Rienso-treated patients included hypotension, infusion site swelling, increased serum ferritin levels, chest pain, diarrhoea, dizziness, ecchymosis, pruritis, chronic renal failure and urticaria.
Danish: Bivirkninger som førte til behandlingsophør i kliniske forsøg og forekom hos ≥2 Rienso-behandlede patienter inkluderede: hypotension, hævelse på infusionsstedet, forhøjede serum-ferritinniveauer, brystsmerter, diarré, svimmelhed, ekkymose, pruritus, kronisk nyreinsufficiens og urticaria.
English: Rienso must not be given to patients if their haemoglobin is greater than 12 g/dl, serum Transferrin Saturation (TSAT) is greater than 50% or ferritin is greater than 800 ng/ml (see section 4.2).
Danish: Rienso må ikke gives til patienter, hvis deres hæmoglobin er højere end 12 g/dl, serum transferrin-mætning (TSAT) er højere end 50 % eller ferritin er højere end 800 ng/ml (se pkt.
English: Dehydration Gout
Danish: Dehydrering Gigt
English: Rienso is not removed by haemodialysis.
Danish: Rienso fjernes ikke ved hæmodialyse.
English: Therefore the MAH proposed as part of this PSUR to amend the current warning in section 4.4 of the SmPC to reflect that interference with MRI can occur up to 6 months after administration of ferumoxytoll which was agreed by the PRAC.
Danish: 4.4 i produktresuméet, så det afspejler, at interferens med MR kan forekomme i op til 6 måneder efter administration af ferumoxytol, hvilket blev tiltrådt af PRAC.
English: Rienso 30 mg/ml solution for infusion.
Danish: Rienso 30 mg/ml infusionsvæske, opløsning.
English: Bronchospasm Cough
Danish: Bronchospasme Hoste
English: - if you are scheduled for magnetic resonance imaging (an MRI scan), as this medicine may interfere with the interpretation of the scan.
Danish: - hvis du har en planlagt MR-scanning, da Rienso kan påvirke tolkningen af scanningen.
English: Incompatibilities • Rienso must not be mixed with other medicinal products, with the exception of the infusion
Danish: • Rienso må ikke blandes med andre lægemidler end de nedenfor nævnte infusionsvæsker.
English: • Rienso must only be mixed with sterile sodium chloride 9 mg/ml (0.9%) or sterile 5% glucose up to a final concentration of 2-8 mg iron per ml.
Danish: • Rienso må kun blandes med steril natriumchlorid 9 mg/ml (0,9 %) eller steril 5 % glucose op til en endelig koncentration på 2-8 mg jern pr. ml.
English: Rienso is a black to reddish-brown solution for infusion.
Danish: Rienso er en sort til rødbrun infusionsvæske, opløsning.
English: congestive heart failure, palpitations, blood vessel dilation, changes in your pulse rate including weak/absent pulse, heart stops beating, heart and breathing stop, blue discolouration of skin and/or mucous membranes due to lack of oxygen in the blood (cyanosis) - fainting/loss of consciousness/unresponsiveness - sudden swelling up of skin or mucous membranes (angioedema), skin rash - wheezing (bronchospasm), cough, upper airway swelling, difficulty breathing (change to
Danish: hjertebanken, udvidede blodkar, forandringer i puls, herunder svag/manglende puls, hjertet ophører at slå, hjerte- og vejrtrækningsstop, blå misfarvning af huden og/eller slimhinderne på grund af manglende ilt i blodet (cyanose) - Besvimelse/tab af bevidsthed/manglende reaktion - Pludselig hævelse af hud eller slimhinder (angioødem), hududslæt - Hvæsende vejrtrækning (bronkospasme), hoste, hævelser i de øvre luftveje, vejrtrækningsbesvær
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 30 mg of iron as ferumoxytol.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml infusionsvæske, opløsning indeholder 30 mg jern som ferumoxytol.
English: Table 1: Recommended Dosing Table for Rienso Administration Total Amount of Rienso to Administer mg of Iron (Number of vials)
Danish: Total mængde Rienso, der skal administreres mg jern (antal hætteglas)
English: Tell your doctor or nurse immediately if you experience any of the following signs and symptoms indicating serious side effects during or shortly after treatment: rash, itching, (sudden) dizziness, light-headedness, (increasing) swelling, difficulty breathing, wheezing or any other problems you may have.
Danish: Fortæl omgående lægen eller sygeplejersken, hvis du oplever nogen af følgende tegn og symptomer, som er tegn på alvorlige bivirkninger under eller kort efter behandlingen:
English: NAME OF THE MEDICINAL PRODUCT Rienso 30 mg/ml solution for infusion Iron as ferumoxytol
Danish: LÆGEMIDLETS NAVN Rienso 30 mg/ml infusionsvæske, opløsning Jern som ferumoxytol
English: Sodium hydroxide (for pH adjustment) Hydrocholric acid (for pH adjustment)
Danish: Natriumhydroxid (til pH-justering) Saltsyre (til pH-justering)
English: Rienso should be administered as an infusion in 50-250 ml of sterile 0.9% sodium chloride or sterile 5% glucose for at least 15 minutes (see sections 6.3 and 6.6).
Danish: Rienso skal indgives som en infusion i 50-250 ml steril 0,9 % natriumchlorid eller steril 5 % glucose over mindst 15 minutter (se pkt.
English: Rare side effects (may affect up to 1 in 1,000 people): - burning, prickling, numbness or tingling sensation of skin - dehydration - upset stomach/indigestion - nose bleed - dry mouth - burning or tingling sensation of tongue/mouth - increased tearing - blurred vision - gout - abnormal blood tests (decreased glucose, elevated potassium, abnormal liver function, elevated type of white blood cell i.e. eosinophilia)
Danish: Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 patienter): - brændende, stikkende, følelsesløs eller snurrende fornemmelse i huden - dehydrering - mavebesvær / fordøjelsesbesvær - næseblod - mundtørhed - brændende eller snurrende fornemmelse i tungen / munden - øget tåredannelse - uklart syn - gigt - unormale blodprøver (nedsat glucose, forhøjet kalium, unormale leverfunktionsprøver, forhøjet antal hvide blodceller, f.eks. eosinofili)
English: Rienso 30 mg/ml solution for infusion Iron as ferumoxytol
Danish: Rienso 30 mg/ml infusionsvæske, opløsning Jern som ferumoxytol
English: • Store in the original package in order to protect from light.
Danish: • Opbevares i den originale emballage for at beskytte produktet mod lys.
English: Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product.
Danish: Det muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet.
English: Rienso must only be mixed with sterile sodium chloride 9 mg/ml (0.9%) or sterile 5% glucose up to a final concentration of 2-8 mg iron per ml.
Danish: Rienso må kun blandes med steril natriumchlorid 9 mg/ml (0,9 %) eller steril 5 % glucose i en koncentration svarende til 2-8 mg jern pr. ml.
English: Proportion of Hgb
Danish: Baseline Hgb
English: A second vial of the medicine should be administered as an infusion two to eight days later if indicated according to the SmPC.
Danish: Der kan om nødvendigt indgives endnu et hætteglas som en infusion to til otte dage senere hvis det er indiceret ifølge produktresuméet.
English: Please see the iron overload section 4.4 and for dosing guidance, see section 4.2.
Danish: 4.4 og for doseringsvejledning, se pkt.
English: Rash (rash, rash generalised, rash pruritic, urticaria) Pruritus (pruritus generalised) Ecchymosis Sweating (hyperhidrosis, night sweats)
Danish: Udslæt (udslæt, generaliseret udslæt, kløende udslæt, urticaria) Pruritus (pruritus, generaliseret pruritus)
English: - discoloured stools - changes in taste - increased or decreased appetite - muscle/joint pain, weakness or stiffness, muscle spasms - headache - chest pain/discomfort - back pain - changes in blood test results (e.g. iron parameters) - allergic reaction including severe allergic reaction (see paragraph "serious side effects")
Danish: - hovedpine - brystsmerter / ubehag - rygsmerter - ændringer i blodprøveresultater (fx jernparametre) - allergiske reaktioner inklusiv alvorlige allergiske reaktionener (se afsnittet “alvorlige bivirkninger”).
English: Uncommon side effects (may affect up to 1 in 100 people): - dizziness - low blood pressure - feeling weak or tired - feeling drowsy or sleepy - flushing, hot flush - feeling hot, fever - sweating (including night sweats) - chills - high blood pressure (sudden increase in blood pressure) - skin rash, itching, darkening of an area of skin or nails, bruising, hives - burning sensation of skin - shortness of breath - diarrhoea - constipation - stomach pain/discomfort - stomach distension or bloating - nausea, vomiting
Danish: Ikke-almindelige bivirkninger (forekommer hos op til 1 ud af 100 patienter): - svimmelhed - lavt blodtryk - følelse af svaghed eller træthed - følelse af døsighed eller søvnighed - rødmen, hedeture - følelse af varme, feber - sved (inklusiv nattesved) - kulderystelser - forhøjet blodtryk (pludselig forhøjelse af blodtrykket) - hududslæt, kløe, mørkfarvning af et område i huden eller neglene, blå mærker, nældefeber - brændende fornemmelse i huden - kortåndethed - diarré - forstoppelse - mavepine / ubehag - udspilet eller oppustet mave - kvalme, opkastning - misfarvet afføring - smagsforandringer - øget eller nedsat appetit - muskel/ledsmerter, svaghed eller stivhed, muskelspasmer
English: • Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of Rienso.
Danish: • Patienter skal overvåges nøje for tegn og symptomer på overfølsomhedsreaktioner herunder overvågning af blodtryk og puls, under og i mindst 30 minutter efter hver infusion af Rienso.
English: • Administer Rienso as an infusion as follows: o 510 mg (one vial) diluted in 50-250 ml of sterile 0.9% sodium chloride or sterile 5% glucose, administered for at least 15 minutes (concentration of 2-8 mg iron per ml).
Danish: • Indgiv Rienso som en infusion efter følgende vejledning: o 510 mg (ét hætteglas) fortyndet i 50-250 ml af steril 0,9 % natriumchlorid eller steril 5 % glucose administreret over mindst 15 minutter (svarer til en koncentration på 2-8 mg jern
English: In addition, patients should be placed in a reclining or semi-reclining position during infusion and for at least 30 minutes thereafter (see section 4.4).
Danish: Patienter bør desuden placeres i en liggende eller en halvt liggende stilling under infusion og i mindst 30 minutter efter endt infusion (se pkt.
English: If you receive more Rienso than you should
Danish: Hvis du har fået for meget Rienso
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet er receptpligtigt med begrænset udlevering (Se Bilag I Produktresumé pkt.
English: Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of Rienso.
Danish: Patienter bør overvåges nøje for tegn og symptomer på overfølsomhedsreaktioner, herunder overvågning af blodtryk og puls under og i mindst 30 minutter efter hver infusion af Rienso.
English: In addition, patients should be placed in a reclining or semi-reclining position during infusion and for at least 30 minutes thereafter.
Danish: Derudover bør patienten placeres i liggende eller halvt liggende stilling under infusionen og i mindst 30 minutter efter endt infusion.
English: - 17 ml solution for infusion contains 510 mg of iron as ferumoxytol.
Danish: - 17 ml infusionsvæske, opløsning indeholder 510 mg jern som ferumoxytol.
English: Justification for not including Braille is accepted
Danish: Fritaget fra krav om brailleskrift
English: Interference with Serological Testing
Danish: Påvirkning af Laboratorieanalyser
English: In a 4 week repeated dose toxicity study in rats after a recovery of 26 weeks hepatic changes (focal or multifocal haemorrhage, hemorrhagic necrosis, chronic inflammation, and/or bile duct hyperplasia) were seen in the female animals (the cumulative HED of the dose groups compares to a safety multiple of 5.1 and 10.5 to the cumulative human therapeutic dose (2 x 510 mg Fe) in a 60 kg human).
Danish: I et 4 ugers toksicitetsstudie med gentaget dosis i rotter, blev der efter 26 ugers restitution set hepatiske forandringer (fokal eller multifokal blødning, hæmorragisk nekrose, kronisk inflammation, og/eller galdevejshyperplasi) hos hundyr.
English: - 1 ml solution for infusion contains 30 mg of iron as ferumoxytol.
Danish: - 1 ml infsuionsæske, opløsning indeholder 30 mg jern som ferumoxytol.
English: Vasodilation
Danish: Vasodilatation
English: What is in this leaflet What Rienso is and what it is used for What you need to know before you receive Rienso
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, om Rienso Sådan bliver du behandlet med Rienso Bivirkninger
English: Responders (%)
Danish: (Mean ± SD, %)
English: Each vial of 17 ml solution contains 510 mg of iron as ferumoxytol.
Danish: Hvert hætteglas med 17 ml injektionsvæske indeholder 510 mg jern som ferumoxytol.
English: - The other ingredients are mannitol, Polyglucose-sorbitol carboxymethylether (PSC), Sodium hydroxide (for pH adjustment, Hydrochloric acid (for pH adjustment) and water for injections.
Danish: - Øvrige indholdsstoffer: Mannitol, polyglucose-sorbitol carboxymethylether (PSC),
English: Lip swelling Swollen tongue
Danish: Hævelse af læber Hævelse af tunge
English: Dizziness Dysgeusia Headache Somnolence Burning sensation
Danish: Hovedpine Somnolens Brændende følelse