FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of Dzuveo was evaluated in two double-blind, placebo-controlled trials involving 221 patients with moderate-to-severe acute postoperative pain (pain intensity of ≥ 4 on a 0-10 scale) after abdominal (studied up to 48-hours) or orthopedic (bunionectomy) surgery (studied up to 12 hours).
Danish: Virkningen af Dzuveo blev vurderet i to dobbeltblindede, placebokontrollerede forsøg med deltagelse af 221 patienter med moderate til svære akutte postoperative smerter (smerteintensitet ≥ 4 på en skala fra 0-10) efter abdominalkirurgi (fulgt i op til 48 timer) eller ortopædkirurgi (knystkirurgi) (fulgt i op til 12 timer).
English: In the case of an excessive dry mouth, patients may be given ice cubes.
Danish: Hvis patienterne får meget tør mund, kan der gives isterninger.
English: Significant respiratory depression or pulmonary compromise.
Danish: Signifikant respirationsdepression eller nedsat lungefunktion.
English: Instruct the patient to not chew or swallow the tablet.
Danish: Patienten bør instrueres i ikke at tygge eller synke resoribletten.
English: Dzuveo should only be prescribed and administered by healthcare professionals who are experienced in the management of opioid therapy; particularly opioid adverse reactions, such as respiratory depression (see section 4.4).
Danish: Dzuveo bør kun ordineres og administreres af sundhedspersonale med erfaring i opioidbehandling, navnlig opioidbivirkninger såsom respirationsdepression (se pkt.
English: Headache Dizziness Somnolence Sedation
Danish: Hovedpine Svimmelhed Somnolens Sedation
English: Analgesia induced by sufentanil is thought to be mediated via activation of μ-opioid receptors primarily within the CNS to alter processes affecting both the perception of and the response to pain.
Danish: Analgesi induceret af sulfatenil menes at være medieret via aktivering af μ-opioidreceptorer, primært i CNS, hvorved processer, der berører smerteopfattelse og smerterespons ændres.
English: Sufentanil may obscure the clinical course of patients with head injury.
Danish: Sufentanil kan tilsløre det kliniske forløb hos patienter med hovedtraume.
English: When considering the use of sufentanil in a patient taking a CNS depressant, the duration of use of the CNS depressant and the patient's response should be assessed, including the degree of tolerance that has developed to CNS depression.
Danish: Når anvendelse af sufentanil overvejes for en patient, der er i behandling med et CNS-depressivum, bør man vurdere varigheden af brugen af det pågældende CNS-depressivum og patientens respons, herunder graden af tolerans for CNS-depression.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from sufentanil therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Dzuveo seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for kvinden.
English: Do Not Use if Pouch Seal is Broken.
Danish: Må ikke bruges, hvis posens forsegling er brudt.
English: ≥1/10,000 to
Danish: ≥ 1/100 til < 1/10
English: After single administration of Dzuveo, mean terminal phase half-live of 13.4 hours (range of 2.5 to 34.4 hours) was observed.
Danish: Efter administration af en enkeltdosis af Dzuveo iagttoges en gennemsnitlig terminal plasmahalveringstid på 13,4 timer (interval: 2,5 til 34,4 timer).
English: Respiratory depression caused by sufentanil can be reversed by opioid antagonists.
Danish: Respirationsdepression forårsaget af sufentanil kan modvirkes med opioidantagonister.
English: - Medicines for the treatment of depression known as Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs).
Danish: - Lægemidler til behandling af depression kaldet serotonin-genoptagelseshæmmere (SSRI'er) og serotonin- noradrenalin -genoptagelseshæmmere (SNRI'er).
English: Onset of analgesia, as measured by pain intensity difference to baseline scores, was greater (p<0.05) for sufentanil versus placebo by 15 minutes after the first dose in the abdominal study and 30 minutes in the bunionectomy study.
Danish: Indsætten af analgesi, målt på forskel i smerteintensitet i forhold til baseline-score, var større (p <0,05) for sufentanil end for placebo 15 minutter efter den første dosis i abdominalstudiet, og 30 minutter i knystkirurgistudiet.
English: - Headache, drowsiness, feeling sleepy.
Danish: - Hovedpine, døsighed, søvnighed.
English: - Low levels of oxygen in your blood, feeling pain in the lower throat, slow shallow breathing.
Danish: - Lavt iltindhold i blodet, smertefornemmelse i nederste del af halsen, langsom, overfladisk vejrtrækning.
English: Sufentanil acts as a full agonist in μ-opioid receptors.
Danish: Sufentanil virker som en fuld agonist i μ-opioidreceptorer.
English: Dzuveo should not be used during pregnancy or in women of childbearing potential not using effective contraception.
Danish: Dzuveo bør ikke anvendes under graviditet eller hos kvinder, der er i den fødedygtige alder og ikke anvender sikker prævention.
English: Patients with a higher pain intensity at one hour after Dzuveo treatment was initiated required more frequent redosing compared to patients with lower pain intensity scores at one hour.
Danish: Patienter med højere smerteintensitet én time efter initiering af behandlingen med Dzuveo havde behov for hyppigere gentagelse af doseringen end patienter med lavere smerteintensitetsscore ved én time.
English: Gastrointestinal effects of sufentanil comprise decreased propulsive motility, reduced secretion and increased muscle tone (up to spasms) of the sphincters of the gastrointestinal tract (see section 4.4).
Danish: De gastrointestinale virkninger af sufentanil er nedsat motilitet, nedsat sekretion og øget muskeltonus (op til spasmer) af mavetarmkanalens sfinktre (se pkt.
English: You can also report side effects directly via the national reporting system listed in
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks
English: Rescue analgesia was allowed in both studies, with a higher proportion of patients in the placebo group requiring rescue medication due to inadequate analgesia (64.8%, 100%; abdominal, bunionectomy) than in the sufentanil group (27.1%, 70.0%;.
Danish: Behovs-analgesi var tilladt i begge studier, og der var en højere andel af patienterne i placebogruppen, som behøvede behovsmedicin på grund af utilstrækkelig analgesi (64,8 % og 100 % ved hhv. abdominalkirurgi og knystkirurgi) end i sufentanilgruppen (27,1 % og 70,0 % ved hhv. abdominalkirurgi og knystkirurgi).
English: Abdominal discomfort Abdominal distension Abdominal Pain upper Epigastric discomfort Gastritis
Danish: Abdominalt ubehag Abdominal distension Øvre abdominalsmerter Epigastrisk ubehag Gastritis
English: A population pharmacokinetic analysis of plasma sufentanil concentrations following usage of Dzuveo did not identify renal function as a significant covariate for clearance.
Danish: En populationsfarmakokinetisk analyse af plasmakoncentrationer af sufentanil efter brug af Dzuveo pegede ikke på nyrefunktion som en betydningsfuld kovariat for clearance.
English: Only limited data are available for the use of sufentanil in such patients.
Danish: For sådanne patienter foreligger der kun begrænsede data om anvendelse af sufentanil.
English: Agitation Apathy Conversion disorder Disorientation Euphoric mood Hallucination Mental status changes Nervousness
Danish: Agitation Apati Dissociativ forstyrrelse Desorientering Eufori Hallucinationer Ændret sindsstemning Nervøsitet
English: Your doctor or nurse will ensure that: - this medicine is not used after the expiry date which is stated on the label and carton after EXP.
Danish: Lægen eller sygeplejersken vil sikre, at: dette lægemiddel ikke anvendes efter den udløbsdato, der står på etiketten og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned dette lægemiddel opbevares i den originale yderpakning for at beskytte mod lys og ilt dette lægemiddel ikke anvendes, hvis der er tegn på nedbrydning
English: The pouch contains one clear plastic SDA with a single blue-coloured tablet housed in the tip, and an oxygen absorber packet.
Danish: Posen indeholder en klar enkeltdosisapplikator af plast med en enkelt blå resoriblet placeret i spidsen og en oxygenabsorberpakke.
English: Analgesia
Danish: Analgesi
English: - Feeling agitated, lack of interest or emotion, lack of energy, disorientation, feeling elated,
Danish: Følelse af uro, manglende interesse eller følelser, mangel på energi, desorientering, opstemthed, hallucinationer eller at se ting, der ikke er der, nervøsitet.
English: Adverse reactions identified either from clinical studies or from post marketing experience with other medicinal products containing sufentanil are summarised in the table below.
Danish: Nedenstående tabel sammenfatter de bivirkninger, der er identificeret enten fra kliniske studier eller fra erfaringer efter markedsføring med andre lægemidler indeholdende sufentanil.
English: However, elderly patients should be observed closely for adverse reactions of sufentanil (see section 5.2).
Danish: Ældre patienter bør dog observeres tæt for bivirkninger af sufentanil (se pkt.
English: Co-administration of sufentanil with a serotonergic agent, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), or Monoamine Oxidase Inhibitors (MAOIs), may increase the risk of serotonin syndrome, a potentially life threatening condition.
Danish: Samtidig administration af sufentanil og et serotonergt middel som f.eks. selektive serotoningenoptagelseshæmmere (SSRI'er), serotonin-noradrenalin-genoptagelseshæmmere (SNRI'er) eller monoaminoxidase-hæmmere (MAOI'er) kan øge risikoen for serotoninsyndrom, som er en potentielt livstruende tilstand.
English: Patients using Dzuveo had a mean SPID12 score that was superior to patients using placebo (25.8 vs. 13.1) in abdominal surgery patients (p<0.001) and (5.93 vs. -6.7) in bunionectomy patients (p=0.005) respectively.
Danish: Patienter, der fik Dzuveo, havde en gennemsnitlig SPID12-score, der var bedre end hos de patienter, der fik placebo (25,8 vs. 13,1) hos hhv. abdominalkirurgipatientern e (p <0,001) og (5,93 vs. -6,7) hos knystkirurgipatienterne (p = 0,005).
English: Dzuveo is to be administered by a healthcare professional in a medically monitored setting only.
Danish: Dzuveo må kun administreres af sundhedspersonale i omgivelser med lægeligt opsyn.
English: Secondary pharmacodynamics effects
Danish: Sekundære farmakodynamiske virkninger
English: Hyperhidrosis Hypoaesthesia facial Pruritus generalized Blister
Danish: Hyperhidrose Facial hypoæstesi Generaliseret pruritus Blærer
English: Therefore, Dzuveo should be used with caution in such patients (see section 4.4).
Danish: Der bør derfor udvises forsigtighed ved anvendelse af Dzuveo hos sådanne patienter (se pkt.
English: Tension headache
Danish: Spændingshovedpine
English: Patients with a higher pain intensity at one hour after sufentanil treatment was initiated required more frequent redosing compared to patients with lower pain intensity scores at one hour.
Danish: Patienter, som havde en højere smerteintensitet én time efter initieringen af behandlingen med sufentanil, behøvede hyppigere gentagelse af doseringen end patienter, der havde lavere smerteintensitetsscore ved én time.
English: Each pouch contains one applicator and one sufentanil 30 micrograms tablet.
Danish: Hver pose indeholder én applikator og én resoriblet med 30 mikrogram sufentanil.
English: 5 x 1 sublingual tablet in a single dose applicator.
Danish: 5 x 1 sublingual resoriblet i en enkeltdosisapplikator.
English: Sufentanil may cause respiratory depression, for which the degree/severity is dose related.
Danish: Sufentanil kan medføre respirationsdepression af dosisafhængig grad/sværhed.
English: Dzuveo is to be administered by a healthcare professional from a disposable single-dose applicator (see section 6.6).
Danish: Dzuveo skal administreres af sundhedspersonale med en enkeltdosisapplikator til engangsbrug (se pkt.
English: - Muscle twitching and spasms.
Danish: - Muskeltrækninger og -spasmer.
English: Maximum concentrations of sufentanil are achieved approximately 60 minutes after a single dose; this is shortened to approximately 40 minutes following repeated hourly dosing.
Danish: Maksimale koncentrationer af sufentanil opnås ca. 60 minutter efter en enkeltdosis.
English: Very common side effects (may affect more than 1 in 10 people): Nausea or feeling sick, vomiting or being sick and generally feeling hot.
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer): Kvalme eller opkastning og generel varmefornemmelse.
English: Common side effects (may affect up to 1 in 10 people): - Inability or difficulty sleeping, feeling anxious or confused, dizziness.
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - Søvnløshed eller søvnbesvær, angst eller forvirring, svimmelhed.
English: Lower pregnancy rates were noted following treatment of males suggesting the potential for an adverse effect on fertility in males.
Danish: Der blev iagttaget færre drægtighedstilfælde efter behandling af hanner som tegn på potentiale for negativ virkning på fertiliteten hos hanner.
English: In the abdominal surgery trial, mean baseline pain intensity was 5.61 (0.13) for sufentanil-treated patients and 5.48 (0.18) for placebo-treated patients.
Danish: I abdominalkirurgiforsøget var den gennemsnitlige smerteintensitet ved baseline 5,61 (0,13) for patienter behandlet med sufentanil, og 5,48 (0,18) for placebobehandlede patienter.
English: Uncommon side effects (may affect up to 1 in 100 people): - Inflammation of the lungs, eye redness and inflammation, inflammation of the throat.
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): Betændelse i lungerne, rødme og betændelse i øjnene, halsbetændelse.
English: Do not use if the Single Dose Applicator (SDA) is damaged Instruct the patient to not chew or swallow the tablet.
Danish: Må ikke bruges, hvis posens forsegling er brudt Må ikke bruges, hvis enkeltdosisapplikatoren er beskadiget Patienten bør instrueres i ikke at tygge eller synke resoribletten.
English: Mean (SEM) baseline intensity in these trials was 6.48 (0.21) for the 12-hour bunionectomy trial in the sufenatil-treated patients and 5.98 (0.30) for placebo-treated patients.
Danish: Gennemsnitsværdien (SEM) af baselineintensiteten i disse forsøg var 6,48 (0,21) for 12-timers knystkirurgiforsøget hos de sufenatilbehandlede patienter, og 5,98 (0,30) for placebobehandlede patienter.
English: Withdrawal syndrome which may include symptoms such as agitation, anxiety, muscle aches, insomnia, sweating and yawning.
Danish: Abstinenssyndrom, der kan bestå i symptomer såsom uro, angst, muskelsmerter, søvnløshed, svedtendens og gaben.
English: NOTE: Avoid direct mucosal contact with the SDA tip.
Danish: BEMÆRK: Undgå at berøre slimhinden direkte med spidsen af applikatoren.
English: - Chest pain and breathing difficulties caused by a blood clot in lung, fluid in the lungs, wheezing.
Danish: Brystsmerter og vejrtrækningsproblemer forårsaget af en blodprop i lungerne, væske i lungerne, hiven efter vejret.
English: Anaphylactic shock
Danish: Anafylaktisk shock
English: Sufentanil is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Det frarådes at anvende sufentanil under graviditet eller til kvinder, der er i den fødedygtige alder og ikke anvender sikker kontraception.
English: 10 x 1sublingual tablet in a single-dose applicator.
Danish: 10 x 1 sublingual resoriblet i en enkeltdosisapplikator.
English: Sufentanil is primarily metabolised by the human cytochrome P450-3A4 enzyme.
Danish: Sufentanil metaboliseres primært af det humane enzym cytokrom P450-3A4.
English: Very common
Danish: Meget almindeli g
English: Sufentanil as a μ-opioid receptor agonist may slow the gastrointestinal motility.
Danish: Sufentanil kan som μ-opioidreceptoragonist nedsætte den gastrointestinale motilitet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sublingual tablet contains 30 micrograms of sufentanil (as citrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver sublingual resoriblet indeholder 30 mikrogram sufentanil (som citrat).
English: C.
Danish: V.
English: Primary pharmacodynamics effects
Danish: Primære farmakodynamiske virkninger
English: Hypomagnesaemia Hypoproteinaemia Hyperkalaemia Diabetes mellitus Hyperglycaemia Hyperlipidaemia Hypophosphataemia Hypovolaemia
Danish: Hypomagnesiæmi Hypoproteinæmi Hyperkaliæmi Diabetes mellitus Hyperglykæmi Hyperlipidæmi Hypofosfatæmi Hypovolæmi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING POUCH
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE POSE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SINGLE-DOSE APPLICATOR
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Insomnia Anxiety Confusional state
Danish: Søvnbesvær Angst Konfusionstilstand
English: Sufentanil is mainly metabolised in humans by the cytochrome P450-3A4 enzyme system (see section 4.5).
Danish: Sufentanil metaboliseres hos mennesker hovedsagelig af cytokrom P450-3A4-enzymsystemet (se pkt.
English: What Dzuveo looks like and contents of the pack Dzuveo is a blue-coloured, flat-faced sublingual tablet with round edges.
Danish: Dzuveo er en blå, sublingual resoriblet med flad overside og runde kanter.
English: Hypoxia
Danish: Hypoxi
English: Tremor Ataxia Dystonia Hyperreflexia Tremor Burning sensation Presyncope Paraesthesia Hypoaesthesia Lethargy Memory impairment Migraine
Danish: Tremor Ataksi Dystoni Hyperrefleksi Brændende fornemmelse Præsynkope Paræstesi Hypoæstesi Letargi Hukommelsesbesvær Migræne
English: Do not use if the Single Dose Applicator (SDA) is damaged.
Danish: Må ikke bruges, hvis enkeltdosisapplikatoren er beskadiget.
English: Instruct the patient to not eat or drink and minimize talking for 10 minutes after receiving the tablet.
Danish: Patienten bør instrueres i at undlade at spise eller drikke og at tale så lidt som muligt i 10 minutter efter at have fået resoribletten.
English: MARKETING AUTHORISATION HOLDER FGK Representative Service GmbH, Heimeranstr.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN FGK Representative Service GmbH Heimeranstr.
English: NAME OF THE MEDICINAL PRODUCT Dzuveo 30 micrograms sublingual tablet
Danish: LÆGEMIDLETS NAVN Dzuveo 30 mikrogram resoribletter, sublinguale
English: Angina pectoris Atrial fibrillation
Danish: Bradykardi Angina pectoris Atrieflimren Ventrikulære ekstrasystoler
English: An opiate antagonist (e.g. naloxone) should be administered in the event of respiratory depression.
Danish: Ved respirationsdepression bør der administreres en opiatantagonist (f.eks. naloxon).
English: Instructions for use of Single Dose Applicator (SDA) Single-Use Product / Do Not Reuse.
Danish: Engangsprodukt/må ikke genbruges.
English: What you need to know before you use Dzuveo Do not use Dzuveo:
Danish: Det skal du vide, før du begynder at bruge Dzuveo Sådan skal du bruge Dzuveo Bivirkninger
English: As Dzuveo may affect your breathing, your doctor or nurse will check your breathing during treatment; - Have a head injury or brain tumour; - Have problems with your heart and circulation, especially slow heart rate, irregular heartbeat,
Danish: Da Dzuveo kan påvirke din vejrtrækning, vil lægen eller sygeplejersken kontrollere din vejrtrækning under behandlingen - har en hovedskade eller en hjernesvulst - har problemer med hjerte og kredsløb, især langsom hjerterytme, uregelmæssig hjerterytme, lavt blodvolumen eller lavt blodtryk - har moderate til svære leverproblemer eller alvorlige nyreproblemer, da disse organer påvirker den måde, hvorpå din krop nedbryder og udskiller lægemidlet - har unormalt langsom tarmbevægelse - har en lidelse i galdeblæren eller bugspytkirtlen - har haft et medicin- eller alkoholmisbrug
English: If these start to develop, tell a doctor or nurse immediately.
Danish: Hvis du begynder at få disse, skal du straks kontakte en læge eller sundhedspersonalet.
English: Impaired hepatic or renal function
Danish: Nedsat lever- eller nyrefunktion
English: Dzuveo passes into breast milk and can cause side effects in the breast-fed child. Breastfeeding is not recommended while you are taking Dzuveo.
Danish: Dzuveo går over i modermælken og kan medføre bivirkninger hos brystbarnet.
English: Rash Dry Skin
Danish: Udslæt Tør hud
English: Patients at higher risk are those with respiratory impairment or reduced respiratory reserve.
Danish: Ved nedsat respiration eller reduceret respiratorisk reserve er risikoen højere.
English: Neoplasm benign, malignant and unspecified (including cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: Sufentanil should be administered with caution to patients with moderate to severe hepatic or severe renal impairment (see section 4.4).
Danish: Der bør udvises forsigtighed ved administration af sufentanil til patienter med moderat til svært nedsat leverfunktion eller svært nedsat nyrefunktion (se pkt.
English: - Difficulty urinating, strong smelling urine, pain urinating, kidney failure.
Danish: Vandladningsbesvær, stærkt lugtende urin, smertefuld vandladning, nyresvigt.
English: 6.6 Special precautions for disposal and other handling Instructions for use of Single Dose Applicator (SDA) Single-Use Product / Do Not Reuse
Danish: 6.6 Regler for bortskaffelse og anden håndtering Brugsanvisning for enkeltdosisapplikator
English: Calcium hydrogen phosphate Hypromellose Croscarmellose sodium Indigo carmine -E132 Stearic acid
Danish: Mannitol (E421) Calciumhydrogenphosphat Hypromellose Croscarmellosenatrium Indigocarmin (E132) Stearinsyre Magnesiumstearat
English: Sufentanil as a μ-opioid receptor agonist may cause spasm of the sphincter of Oddi.
Danish: Sufentanil kan som μ-opioidreceptoragonist forårsage krampe i sphincter oddi.
English: Lock
Danish: Lås
English: Sublingual tablet.
Danish: Resoriblet, sublingual.
English: Bradypnoea Epistaxis Hiccups Apnoea Atelectasis Hypoventilation Pulmonary embolism Pulmonary oedema Respiratory distress Respiratory failure Wheezing
Danish: Bradypnø Epistaxis KløgningApnø Atelektase Hypoventilation Lungeemboli Lungeødem Besværet respiration Respirationssvigt Rhonci
English: Diastolic hypotension Orthostatic hypotension
Danish: Ortostatisk hypertension Rødmen Diastolisk hypotension Ortostatisk hypotension
English: Sufentanil may cause respiratory depression (see section 4.4) and also suppresses the cough reflex.
Danish: Sufentanil kan medføre respirationsdepression (se pkt.
English: Hypocalcaemia Hypoalbuminaemia Hypokalaemia Hyponatraemia
Danish: Hypocalcæmi Hypoalbuminæmi Hypokaliæmi Hyponatriæmi
English: Dzuveo 30 micrograms sublingual tablets sufentanil
Danish: Dzuveo 30 mikrogram resoribletter, sublinguale sufentanil
English: Constipation Dyspepsia Flatulence Dry Mouth
Danish: Konstipation Dyspepsi Flatulens Mundtørhed
English: Depress the green Pusher to deliver the tablet to the patient's sublingual space and confirm tablet placement.
Danish: Tryk på den grønne trykknap for at levere resoribletten under tungen, og kontrollér at resoribletten er på plads.
English: Each sublingual tablet contains 30 micrograms sufentanil (as citrate).
Danish: Hver sublingual resoriblet indeholder 30 mikrogram sufentanil (som citrat).
English: - This medicine may also cause changes in levels of red blood cells, white blood cells, calcium,
Danish: Dette lægemiddel kan også medføre ændringer i blodets indhold af røde blodlegemer, hvide blodlegemer, calcium, albumin, kalium og natrium, som kun kan påvises ved en blodprøve.
English: Contents of the pack and other information What Dzuveo contains - The active substance is sufentanil.
Danish: Pakningsstørrelser og yderligere oplysninger Dzuveo indeholder:
English: General disorders and administration site conditions
Danish: Almene symptomer ogreaktioner på administrationsstedet