FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with absent to low antibody levels showed a robust reduction in urinary GAG level, whereas patients with high antibody titers showed variable reduction in urinary GAG.
Danish: Patienter, som ikke havde lave antistofniveauer, havde et kraftigt fald i GAG-niveauet i urin, hvorimod patienter med høje antistoftitre udviste et variabelt fald i GAG-niveauet i urin.
English: It is not known whether Aldurazyme appears in breast milk.
Danish: Det vides ikke, om Aldurazyme udskilles i modermælken.
English: If these reactions occur, the Aldurazyme infusion should be stopped immediately and appropriate treatment will be started by your doctor.
Danish: Hvis sådanne reaktioner optræder, skal infusionen af Aldurazyme straks afbrydes, og din læge vil iværksætte en hensigtsmæssig behandling.
English: For instruction on dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om fortynding af lægemidlet før administration, se pkt.
English: Withdraw the required volume from the Aldurazyme vials and combine the withdrawn volumes.
Danish: • Udtag den ønskede mængde fra Aldurazyme-hætteglassene og saml de udtagne mængder.
English: If these reactions occur, immediate discontinuation of Aldurazyme is recommended and appropriate medical treatment should be initiated.
Danish: Hvis sådanne reaktioner forekommer, anbefales øjeblikkelig seponering af Aldurazyme, og der bør iværksættes hensigtsmæssig lægebehandling.
English: Mechanism of action
Danish: Virkningsmekanismer
English: Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis I (MPS I; α-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease (see section 5.1).
Danish: Aldurazyme er indiceret til langvarig enzymerstatningsterapi hos patienter med en bekræftet diagnose på mukopolysakkaridose I (MPS I; α-L-iduronidase-insufficiens) til behandling af sygdommens ikkeneurologiske manifestationer (se pkt.
English: A Phase 2 open-label, 1-year study was conducted that mainly assessed the safety and pharmacokinetics of Aldurazyme in 20 patients less than 5 years of age at the time of enrolment (16 patients with the severe phenotype and 4 with the intermediate phenotype).
Danish: Der blev udført en et-årig open-label, fase 2-studie, som hovedsagligt vurderede sikkerhed og farmakokinetik ved Aldurazyme hos 20 patienter, der var under 5 år ved studiets begyndelse (16 patienter med den alvorlige fænotype og 4 med den intermediære fænotype).
English: If clinically indicated, administration of pre-treatment medications with subsequent infusions of Aldurazyme should be considered.
Danish: Hvis der er klinisk indikation herfor, bør medicinering før behandling ved efterfølgende infusioner med Aldurazyme overvejes.
English: Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAGs).
Danish: Sygdomme i forbindelse med oplagring af mukopolysakkarid skyldes mangel på de specifikke lysosomal-enzymer, der er nødvendige for glykosaminoglykanernes (GAG) katabolisme.
English: When you experience such a reaction, you should immediately contact your doctor.
Danish: Hvis du oplever en sådan reaktion, skal du omgående kontakte din læge.
English: Shoulder flexion Range Of Motion (degrees)
Danish: Bevægelsesinterval, skulderfleksion (grader)
English: A phase 4 study was conducted to evaluate the pharmacodynamic effects on urinary GAGs, liver volume, and 6MWT, of different Aldurazyme dose regimens.
Danish: Der blev gennemført et fase 4-studie for at undersøge de farmakodynamiske effekter på GAGniveauerne i urin, levervolumen og 6MWT ved forskellige dosisregimener med Aldurazyme.
English: You should not be given Aldurazyme during pregnancy unless clearly necessary.
Danish: Aldurazyme bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Body temperature increased, oxygen saturation decreased
Danish: Forhøjet legemstemperatur, nedsat iltmætning
English: Pack sizes: 1, 10 and 25 vials.
Danish: Pakningsstørrelser: 1, 10 og 25 hætteglas.
English: The safety and efficacy of Aldurazyme in patients older than 65 years have not been established and no dosage regimen can be recommended in these patients.
Danish: Aldurazymes sikkerhed og virkning hos patienter, der er mere end 65 år, er ikke klarlagt, og ingen dosering kan anbefales til disse patienter.
English: One clinical study focussed mainly on assessing the effect of Aldurazyme on the systemic manifestations of MPS I such as poor endurance, restrictive lung disease, upper airway obstruction, reduced joint range of motion, hepatomegaly and visual impairment.
Danish: Det ene kliniske studie koncentrerede sig hovedsagelig om at vurdere effekten af Aldurazyme på de systemiske manifestationer af MPS I, f.eks. ringe udholdenhed, restriktiv lungesygdom, obstruktion af de øvre luftveje, nedsat bevægelsesinterval i led, hepatomegali og synsforringelse.
English: People with MPS I disease have either a low level or no level of an enzyme called α-L-iduronidase, which breaks down specific substances (glycosaminoglycans) in the body.
Danish: Personer med MPS I har et lavt niveau af eller mangler helt et enzym, der hedder α-L-iduronidase, som nedbryder bestemte stoffer (glykosaminoglycaner) i kroppen.
English: MPS I is a heterogeneous and multisystemic disorder characterised by the deficiency of α-L-iduronidase, a lysosomal hydrolase which catalyses the hydrolysis of terminal α-L-iduronic residues of dermatan sulfate and heparan sulfate.
Danish: MPS I er en heterogen og multisystemisk sygdom, der er karakteriseret ved mangel på α-L-iduronidase, en lysosomal hydrolase, der katalyserer hydrolysen for terminale α-L-iduroniske rester af dermatansulfat og heparansulfat.
English: In clinical studies IARs were usually manageable by slowing the rate of infusion and by (pre-) treating the patient with antihistamines and/or antipyretics (paracetamol or ibuprofen), thus enabling the patient to continue treatment.
Danish: I kliniske studier kunne IAR normalt styres ved at nedsætte infusionshastigheden og ved at (præ)medicinere patienten med antihistaminer og/eller antipyretika (paracetamol eller ibuprofen), hvorved patienten blev i stand til at fortsætte behandlingen.
English: Marketing Authorisation Holder: Genzyme Europe B.V.
Danish: Indehaver af markedsføringstilladelsen: Genzyme Europe B.V.
English: Post-marketing experience of infusion-associated reactions revealed reporting of cyanosis, hypoxia, tachypnoea, pyrexia, vomiting, chills and erythema, in which some of these reactions were severe.
Danish: Efter markedsføringen er der indberettet infusionsrelaterede reaktioner i form af cyanose, hypoksi, takypnø, pyreksi, opkastning, kulderystelser og erytem, hvoraf nogle var alvorlige.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/253/001-003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/253/001-003
English: The recommended dosage regimen of Aldurazyme is 100 U/kg body weight given once every week as an intravenous infusion.
Danish: Den anbefalede dosering for Aldurazyme er 100 E/kg kropsvægt, der indgives én gang om ugen som intravenøs infusion.
English: With initial administration of Aldurazyme or upon re-administration following interruption of treatment, it is recommended that patients be administered pre-treatment medicines (antihistamines and/or antipyretics) approximately 60 minutes prior to the start of the infusion, to minimise the potential occurrence of IARs.
Danish: Ved første indgivelse af Aldurazyme eller ved genindgivelse efter afbrydelse af behandlingen anbefales det, at patienterne får medicin før behandlingen (antihistaminer og/eller antipyretika) ca. 60 minutter før infusionens start for at minimere den eventuelle forekomst af infusionsrelaterede reaktioner.
English: Very common symptoms (may affect more than 1 in 10 people) which were not serious include headache, nausea, abdominal pain, rash, joint disease, joint pain, back pain, pain in arms or legs, flushing, fever, chills, increased heart rate, increased blood pressure, and reaction at the infusion site.
Danish: Meget almindelige symptomer (kan ramme flere end 1 ud af 10 personer), som ikke var alvorlige, omfatter hovedpine, kvalme, mavesmerter, udslæt, ledsygdom, ledsmerter, rygsmerter, smerter i arme eller ben, ansigtsrødme, feber, kulderystelser, hurtig hjerterytme (puls), forhøjet blodtryk og reaktioner på infusionsstedet.
English: The initial infusion rate of 2 U/kg/h may be gradually increased every fifteen minutes, if tolerated, to a maximum of 43 U/kg/h.
Danish: Den indledende infusionshastighed på 2 E/kg/t kan gradvist øges for hver 15 minutter, hvis det tåles, til maksimalt 43 E/kg/t.
English: The concentrate for solution for infusion has to be diluted before administration and is for intravenous use (see information for health care professionals).
Danish: Instruktioner vedrørende anvendelsen - opløsning og indgivelse Koncentratet til opløsning til infusion skal fortyndes før indgivelse og er beregnet til intravenøs brug (se oplysningerne til sundhedspersonalet).
English: Patients who have developed antibodies or symptoms of IARs should be treated with caution when administering Aldurazyme (see sections 4.3 and 4.8).
Danish: Patienter, der har udviklet antistoffer eller symptomer på IAR, skal behandles med forsigtighed ved indgivelse af Aldurazyme (se pkt.
English: Other medicines and Aldurazyme
Danish: Brug af anden medicin sammen med Aldurazyme
English: There is not enough experience of the use of Aldurazyme in pregnant women.
Danish: Der er ikke tilstrækkelig erfaring med brug af Aldurazyme til gravide.
English: MedDRA Preferred term
Danish: Foretrukken term iht.
English: Patients treated with Aldurazyme may develop infusion-associated reactions (IARs), defined as any related adverse event occurring during the infusion or until the end of the infusion day (see section 4.8).
Danish: Patienter, der behandles med Aldurazyme, kan udvikle infusions-relaterede reaktioner (IAR), der defineres som enhver relateret, negativ begivenhed, der indtræffer under infusionen eller inden infusionsdagens afslutning (se pkt.
English: What Aldurazyme contains - The active substance is laronidase.
Danish: Aldurazyme indeholder: - Aktivt stof: laronidase.
English: Three clinical trials were performed with Aldurazyme to assess its efficacy and safety.
Danish: Der blev udført tre kliniske studier med henblik på at bestemme effekt og sikkerhed ved anvendelsen af Aldurazyme.
English: You should not be given Aldurazyme
Danish: Du må ikke få Aldurazyme:
English: Angioneurotic edema, swelling face, urticaria, pruritus, cold sweat, alopecia, hyperhidrosis
Danish: Angioneurotisk ødem, hævet ansigt, urticaria, pruritus, koldsved, alopeci, hyperhidrose
English: It is recommended that the diluted Aldurazyme solution be administered to patients using an infusion set equipped with an 0.2 µm in-line filter.
Danish: Det anbefales, at den fortyndede Aldurazyme-opløsning indgives til patienterne med et infusionssæt, der er udstyret med et 0,2 µm in-line-filter.
English: Cyanosis, hypoxia, tachypnoea, bronchospasm, respiratory arrest
Danish: Cyanose, hypoksi, takypnø, bronkospasme, respirationsstop
English: Respiratory distress, dyspnoea, cough
Danish: Respirationsbesvær, dyspnø, hoste
English: For information on pre-treatment, see section 4.4.
Danish: 4.4 for oplysninger om præmedicinering.
English: What you need to know before you are given Aldurazyme
Danish: Det skal du vide, før du får Aldurazyme
English: Each vial of Aldurazyme is intended for single use only.
Danish: Hvert hætteglas Aldurazyme er kun beregnet til engangsbrug.
English: The initial infusion rate of 2 U/kg/h may be incrementally increased every fifteen minutes, if tolerated, to a maximum of 43 U/kg/h.
Danish: Den initiale infusionshastighed på 2 E/kg/t kan øges trinvist hvert 15. minut, og hvis det tåles, til maksimalt 43 E/kg/t.
English: No information is available on the effects of Aldurazyme on fertility.
Danish: Der er ingen oplysninger om Aldurazymes indvirkning på frugtbarheden.
English: Hypotension, pallor, peripheral coldness
Danish: Hypotension, bleghed, perifer kuldefølelse
English: Administration of Aldurazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.
Danish: Indgivelse af Aldurazyme skal foregå i hensigtsmæssige, kliniske omgivelser, hvor genoplivningsudstyr til akut opståede situationer er let tilgængeligt.
English: Paraesthesia, dizziness
Danish: Paræstesi, svimmelhed
English: This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Danish: Dette lægemiddel indeholder natrium og indgives i 0,9% natriumchloridinfusionsvæske (se pkt.
English: In case of a recurrent moderate IAR or re-challenge after a single severe IAR, pre-treatment should be considered (antihistamines and paracetamol/ibuprofen and/or corticosteroids) and a reduction of the infusion rate to 1/2 - 1/4 the rate of the infusion at which the previous reaction occurred.
Danish: I tilfælde af en tilbagevendende, moderat IAR eller genudsættelse efter en enkelt, svær IAR skal der overvejes forbehandling (antihistaminer og paracetamol/ibuprofen og/eller kortikosteroider) og en reduktion af infusionshastigheden til 1/2 til 1/4 af den infusionshastighed, hvor den foregående reaktion optrådte.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Aldurazyme på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om Aldurazyme findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: You should not be given this medicine after the expiry date which is stated on the label after the letters EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Da der ikke foreligger studier vedrørende eventuelle uforligeligheder, bør dette præparat ikke blandes med andre præparater end dem, der er anført under pkt.
English: In case of a mild or moderate IAR, treatment with antihistamines and paracetamol/ibuprofen should be considered and/or a reduction in the infusion rate to half the infusion rate at which the reaction occurred.
Danish: I tilfælde af en mild eller moderat infusionsrelateret reaktion (IAR) skal behandling med antihistaminer og paracetamol/ibuprofen overvejes og/eller reduktion af infusionshastigheden til halvdelen af den infusionshastighed, hvor reaktionen optrådte.
English: Driving and using machines The effects on the ability to drive and to use machines have not been studied.
Danish: Trafik- og arbejdssikkerhed Virkningen på evnen til at køre bil eller betjene maskiner er ikke undersøgt.
English: The most frequent adverse drug reactions (ADRs) were: headache, nausea, abdominal pain, rash, arthralgia, backpain, pain at extremity, flushing, pyrexia, infusion site reactions, blood pressure increased, oxygen saturation decreased,
Danish: De hyppigste bivirkninger (ADR'er) var: hovedpine, kvalme, mavesmerter, udslæt, artralgi, rygsmerter, smerter i ekstremiteter, flushing, pyrexi, reaktioner på infusionsstedet, forhøjet blodtryk, nedsat iltmætning, takykardi og kulderystelser.
English: The safety and efficacy of Aldurazyme in patients with renal or hepatic insufficiency have not been evaluated and no dosage regimen can be recommended in these patients.
Danish: Aldurazymes sikkerhed og virkning hos patienter med nedsat nyre- og leverfunktion er ikke klarlagt, og der kan ikke gives nogen anbefalinger vedrørende dosering til disse patienter.
English: The patients were scheduled to receive Aldurazyme 100 U/kg weekly infusions for a total duration of 52 weeks.
Danish: Det var planlagt, at patienterne skulle have ugentlige infusioner af 100 U/kg Aldurazyme i 52 uger.
English: Mix the solution for infusion gently.
Danish: • Bland opløsningen til infusion forsigtigt.
English: MARKETING AUTHORISATION HOLDER Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands.
Danish: Indehaver af markedsføringstilladelsen Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Holland.
English: AUC∞ (h•U/ml) 0.930 ± 0.214 CL (ml/min/kg) 1.96 ± 0.495 Vz (l/kg)
Danish: Cmax (U/ml) AUC∞ (h•E/ml) CL (ml/min/kg) Vz (l/kg) Vss (l/kg) t1/2 (t)
English: Genzyme Europe B.V. - NL
Danish: Nederland Genzyme Europe B.V.
English: Chills, feeling hot, feeling cold, fatigue, influenza like illness
Danish: Kulderystelser, varmefølelse, kuldefølelse, træthed, influenzalignende sygdom
English: • influenza like illness
Danish: • influenzalignende sygdom
English: The recommended dosage regimen of Aldurazyme is 100 U/kg body weight administered once every week.
Danish: Dosering Den anbefalede dosering for Aldurazyme er 100 E/kg kropsvægt, der indgives én gang om ugen.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 100 U of laronidase.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml indeholder 100 E laronidase.
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of concentrate for solution for infusion.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 1 hætteglas koncentrat til infusionsvæske, opløsning.
English: Infusion 1 Mean ± SD
Danish: Infusion 1 Gnsn.
English: Determine the total volume of infusion based on the individual patient's weight, either 100 ml (if body weight is less or equal than 20 kg) or 250 ml (if body weight is more than 20 kg) of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: • Beregn den samlede infusionsmængde på basis af den enkelte patients vægt, enten 100 ml (hvis kropsvægten er under eller lig med 20 kg) eller 250 ml (hvis kropsvægten er over 20 kg) 9 mg/ml (0,9%) natriumchloridopløsning til infusion.
English: A few patients who had a prior history of severe MPS I related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm (airway constriction), respiratory arrest, and swelling of the face.
Danish: Nogle få patienter, som havde tidligere tilfælde af alvorlige angreb på øvre luftveje og lunger, som var MPI I-relateret, oplevede alvorlige reaktioner, herunder bronkospasme (forsnævring af luftvejene), åndedrætsstop og hævelse i ansigtet.
English: Before dilution, visually inspect each vial for particulate matter and discoloration.
Danish: • Før fortynding inspiceres hvert hætteglas visuelt for fremmedlegemer og misfarvning.
English: The clear to slightly opalescent and colourless to pale yellow solution should be free of visible particles.
Danish: Den klare til let opaligerede og farveløse til lysegule opløsning skal være fri for synlige partikler.
English: ADRs were all mild to moderate in severity.
Danish: De uønskede hændelser var alle milde til moderate i styrke.
English: • cold sweat, heavy sweating
Danish: • koldsved, kraftig svedtendens
English: Based on its metabolism, laronidase is an unlikely candidate for Cytochrome P450 mediated interactions.
Danish: På basis af dets metabolisme er det ikke sandsynligt, at laronidase vil medføre CYP-fremkaldte interaktioner.
English: EU/1/03/253/002 10 Vials
Danish: EU/1/03/253/002 10 Hætteglas
English: EU/1/03/253/003 25 Vials
Danish: EU/1/03/253/003 25 Hætteglas
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/253/001 1 Vial
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/03/253/001 1 Hætteglas
English: What Aldurazyme is and what it is used for What you need to know before you are given Aldurazyme How Aldurazyme is given
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Aldurazyme Sådan får du Aldurazyme Bivirkninger
English: Tel +44 (0)845 372 7101
Danish: Sanofi Tel +44 (0)845 372 7101
English: ADRs to Aldurazyme reported during a Phase 2 study in a total of 20 patients, under 5 years of age and mainly of the severe phenotype, treated up to 12 months are listed below.
Danish: Uønskede hændelser, der blev indberettet under fase 2 studiet med i alt 20 patienter i alderen 5 år eller yngre, hovedsagligt af den alvorlige fænotype og behandlet med Aldurazyme i op til 12 måneder, er anført nedenfor.
English: How to store Aldurazyme
Danish: Sådan får du Aldurazyme
English: Very common oxygen saturation decreased Very common
Danish: Undersøgelser forhøjet blodtryk meget almindelig nedsat iltmætning meget almindelig
English: The 200 U/kg IV every 2 weeks regimen may be an acceptable alternative for patients with difficulty receiving weekly infusions; however, there is no evidence that the long term clinical efficacy of these two dose regimens is equivalent.
Danish: hver 2. uge kan være et acceptabelt alternativ for patienter, som har problemer med at få infusioner hver uge.
English: MedDRA System Organ Class
Danish: Systemorganklasse iht.
English: Infusion 26 Mean± SD
Danish: Infusion 26 Gnsn.
English: Prior to use visually inspect the solution for particulate matter.
Danish: • Før brugen efterses opløsningen for partikler.
English: Urinary GAG levels decreased by 77% and 66% in the Placebo/Aldurazyme and Aldurazyme/Aldurazyme groups, respectively; at the end of the study one-third of the patients (15 of 45) had reached normal urinary GAG levels.
Danish: GAG-niveauerne i urin faldt med henholdsvis 77% og 66% i gruppen på placebo/Aldurazyme og i gruppen på Aldurazyme/Aldurazyme.
English: In this 26-week open label study, 33 MPS I patients received 1 of 4 dose regimens of Aldurazyme: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks; or 300 U/kg IV every 2 weeks.
Danish: I dette 26-ugers åbne studie fik 33 MPS I-patienter 1 af 4 dosisregimener med Aldurazyme: 100 E/kg i.v.
English: Severe IARs have been reported in patients with pre-existent severe underlying upper airway involvement and therefore specifically these patients should continue to be closely monitored and only be infused with Aldurazyme in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.
Danish: Disse patienter bør derfor specifikt fortsat overvåges nøje og kun modtage infusion af Aldurazyme i et hensigtsmæssigt klinisk miljø, hvor genoplivningsudstyr til brug i nødstilfælde er umiddelbart tilgængeligt.
English: Infusion 12 Mean ± SD
Danish: Infusion 12 Gnsn.
English: It is a solution that is clear to slightly opalescent, and colourless to pale yellow.
Danish: Det er en opløsning, der er klar til let opaliserende og farveløs til lysegul.
English: Mean change from pre-treatment baseline Percent predicted FVC (%)1
Danish: Procent forventet FVC (%)1
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 June 2003
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: In a phase 4 study 33 MPS I patients received 1 of 4 dose regimens: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks or 300 U/kg IV every 2 weeks.
Danish: I et fase 4-studie fik 33 MPS I-patienter 1 af 4 dosisregimener: 100 E/kg i.v.
English: The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
Danish: Koncentratet til opløsning til infusion skal fortyndes med 9 mg/ml (0,9%) natriumchloridopløsning til infusion med aseptisk teknik.