FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Danish: Patienter med en legemsvægt på under 50 kg kan opleve flere bivirkninger og har større risiko for at måtte afbryde behandlingen på grund af bivirkninger.
English: Patients with mild dementia (MMSE 18-24)
Danish: Patienter med mild demens (MMSE 18-24)
English: 1 Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate.
Danish: 1 Baseret på ANCOVA med behandling og land som faktorer og baseline ADAS-Cog som covariat.
English: Allergic contact dermatitis should be suspected if application site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g. increasing erythema, oedema, papules, vesicles) and if symptoms do not significantly improve within 48 hours after patch removal.
Danish: Der skal være mistanke om allergisk kontakteksem, hvis applikationsstedets reaktioner spreder sig ud over plasterstørrelsen, hvis der er tegn på en mere lokal reaktion (f.eks. stigende erytem, ødem, blærer, vesikler), og hvis symptomerne ikke bedres væsentligt inden for 48 timer efter fjernelse af plaster.
English: 3 years Rivastigmine HEXAL oral solution should be used within 1 month of opening the bottle.
Danish: 3 år Rivastigmine HEXAL oral opløsning skal anvendes inden 1 måned efter, at flasken er åbnet.
English: Clinical studies in dementia associated with Parkinson's disease The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Danish: Kliniske studier af demens, der er associeret med Parkinsons sygdom Effekten af rivastigmin ved demens, der er associeret med Parkinsons sygdom, er demonstreret i et 24ugers multicenter, dobbelt-blindt, placebo-kontrolleret hovedstudie og dets 24-ugers open-label forlængelsesfase.
English: Hard gelatine capsules Novartis Farmacéutica S.A. Ronda Santa Maria 158 ES-08210 Barberà del Vallès Barcelona
Danish: Hårde gelatinekapsler Novartis Farmacéutica S.A. Ronda Santa Maria 158 ES-08210 Barberà del Vallès Barcelona
English: Repeated-dose toxicity studies in rats, mice and dogs revealed only effects associated with an exaggerated pharmacological action.
Danish: Kroniske toksicitetsundersøgelser af rotter, mus og hunde viste kun effekter, der var forbundet med en unormal høj farmakologisk aktivitet.
English: Filling the syringe • Pull the plunger upwards until it reaches the right mark for the dose that your doctor has prescribed.
Danish: • Træk stemplet opad, indtil det når målestregen for den dosis, din læge har foreskrevet.
English: Taking the two medicines together could cause problems such as stiff limbs and trembling hands.
Danish: Hvis de to lægemidler tages samtidig, kan det give problemer som f.eks. stive arme og ben og rysten i hænderne.
English: Patients who develop application site reactions suggestive of allergic contact dermatitis to rivastigmine patch and who still require rivastigmine treatment should only be switched to oral rivastigmine after negative allergy testing and under close medical supervision.
Danish: Patienter, der får reaktioner på applikationsstedet, som tyder på allergisk kontakteksem forårsaget af rivastigminplasteret, og som fortsat har behov for rivastigminbehandling, bør kun skifte til oral rivastigmin efter en negativ allergitest og under tæt lægelig supervision.
English: Based on in vitro studies, no pharmacokinetic interaction is expected with medicinal products metabolised by the following cytochromes isoemzymes: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, or CYP2B6.
Danish: Resultater fra in vitro-undersøgelser viser, at der ikke forventes nogen farmakokinetisk interaktion med lægemidler, der metaboliseres af følgende cytokrom-isoenzymer: CYP1A2, CYP2D6, CYP3A4 / 5, CYP2E1, CYP2C9, CYP2C8, CYP2C19 eller CYP2B6.
English: Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose 104 times the maximum clinical exposure.
Danish: Rivastigmin var ikke mutagen i et standardbatteri af in vitro- og in vivo-test, på nær i en kromosonal Abberation Test i humane perifere lymfocytter ved en dosis på 104 gange den maksimale kliniske relevante.
English: - Blister of clear PVC tray with blue lidding foil with 14 capsules.
Danish: - Blister med klar PVC-bund og blåt folielåg med 14 kapsler.
English: A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of rivastigmine by 23% in patients with Alzheimer's disease (n=75 smokers and 549 non-smokers) following rivastigmine oral capsule doses of up to 12 mg/day.
Danish: En farmakokinetisk populationsanalyse viste, at brug af nikotin øger den orale clearance af rivastigmin med 23 % hos patienter med Alzheimers sygdom (n = 75 rygere og 549 ikke-rygere) efter orale kapsler med rivastigmin-doser på op til 12 mg/dag.
English: Rivastigmine oral solution may be swallowed directly from the syringe.
Danish: Rivastigmin oral opløsning kan synkes direkte fra sprøjten.
English: If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day.
Danish: Hvis denne dosis tåles godt efter mindst to ugers behandling, kan dosis øges til 3 mg to gange daglig.
English: An updated RMP should be submitted:
Danish: Der skal indsendes en opdateret risikohåndteringsplan:
English: • The highest dose that should be taken is 6.0 mg (corresponding to 3 ml) twice a day.
Danish: • Den højeste dosis, som bør tages, er 6 mg (svarende til 3 ml) to gange daglig.
English: CARTON FOR GLASS BOTTLE LABEL FOR GLASS BOTTLE
Danish: KARTON TIL GLASFLASKE ETIKET TIL GLASFLASKE
English: Other side effects seen with transdermal patches and which may occur with the hard capsules:
Danish: Andre bivirkninger, der er set med depotplaster, og som kan forekomme ved brug af hårde kapsler:
English: Although a treatment effect was demonstrated in the overall study population, the data suggested that a larger treatment effect relative to placebo was seen in the subgroup of patients with moderate dementia associated with Parkinson's disease.
Danish: Selvom behandlingseffekten blev demonstreret i den samlede studiepopulation, indikerede data, at en større behandlingseffekt i forhold til placebo blev set i subgruppen af patienter med moderat demens, der var associeret med Parkinsons sygdom.
English: • Accidentally falling
Danish: Tilfældige fald
English: They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country.
Danish: De er pakket i blisterkort, som findes i tre forskellige pakningsstørrelser (28, 56 eller 112 kapsler), eller i plastikbeholder med 250 kapsler.
English: 50 ml oral solution 120 ml oral solution
Danish: 50 ml oral opløsning 120 ml oral opløsning
English: Sandoz Farmacéutica, S.A. / BEXAL FARMACÉUTICA, S.A.
Danish: Sandoz Farmacéutica, S.A. / BEXAL PHARACÉUTICA, S.A.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Hvis du har yderligere spørgsmål om brugen af denne medicin, så spørg din læge eller apotekspersonalet.
English: CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER OG BEGRÆNSNINGER FOR SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Important information about some of the ingredients of Rivastigmine HEXAL
Danish: Vigtige oplysninger om visse af indholdsstofferne i Rivastigmine HEXAL
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Danish: Rivastigmine virker ved at blokere de enzymer, der nedbryder acetylkolin: acetylkolinesterase og butyrylkolinesterase.
English: Κηφισίας 18 & Γκύζη GR - 151 25 Μαρούσι
Danish: Λ. Κηφισίας 18 & Γκύζη, Μαρούσι
English: Skin application site reactions may occur with rivastigmine patch and are usually mild or moderate in intensity.
Danish: Reaktioner på hudapplikationsstedet kan forekomme med rivastigminplaster, som sædvanligvis er milde eller moderate af intensitet.
English: • Then, put the syringe back in its protective case.
Danish: • Læg derefter doseringssprøjten tilbage i det beskyttende hylster.
English: The recommended maximum daily dose is 6 mg twice a day.
Danish: Den anbefalede maksimale daglige dosis er 6 mg to gange daglig.
English: The results for clinically relevant responders pooled from two flexible dose studies out of the three pivotal 26-week multicentre studies in patients with mild-to-moderately severe Alzheimer's Dementia, are provided in Table 4 below.
Danish: Resultaterne for patienter med klinisk relevant respons, der var poolet fra to fleksible dosisundersøgelser ud af tre pivotale 26-ugers multicenterundersøgelser hos patienter med mild til moderat svær Alzheimers demens, er vist i Tabel 4 nedenfor.
English: Rivastigmine HEXAL is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Danish: Rivastigmine HEXAL anvendes til behandling af hukommelsesproblemer hos patienter med Alzheimers sygdom og demens, som er en progressiv hjernesygdom, der lidt efter lidt påvirker hukommelse, intelligens og adfærd.
English: Not known (frequency cannot be estimated from the available data)
Danish: ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category.
Danish: Tabuleret liste over bivirkninger Bivirkninger i tabel 1 og tabel 2 er opstillet i henhold til MedDRA organklasse og hyppighed.
English: Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
Danish: Rivastigmine tilhører en medicingruppe, der kaldes kolinesterasehæmmere.
English: - This medicine has been prescribed for you only .
Danish: - Denne medicin er blevet ordineret til dig personligt.
English: Urinary infection
Danish: Urinvejsinfektion
English: Rivastigmine oral solution and rivastigmine capsules may be interchanged at equal doses.
Danish: Rivastigmin oral opløsning og rivastigmin-kapsler kan substitueres ved ens dosis.
English: Rivastigmine might interfere with the activity of anticholinergic medicinal products (e.g. oxybutynin, tolterodine).
Danish: Rivastigmin kan interferere med antikolinerge lægemidlers aktivitet (f.eks. oxybutynin, tolterodin).
English: In view of its pharmacodynamic effects and possible additive effects, rivastigmine should not be given concomitantly with other cholinomimetic substances.
Danish: Som følge af sine farmakodynamiske virkninger og mulige additive virkninger bør rivastigmin ikke gives samtidig med andre kolinomimetika.
English: Only for carton box: 2D barcode carrying the unique identifier included.
Danish: Kun for kartonæske: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin, har brugt det for nylig eller måske vil tage den.
English: Patients with visual hallucinations
Danish: Patienter med visuelle hallucinationer
English: The active substance of Rivastigmine HEXAL is rivastigmine.
Danish: Det aktive stof i Rivastigmine HEXAL er rivastigmin.
English: Rivastigmine HEXAL 1.5 mg hard capsules Rivastigmine HEXAL 3 mg hard capsules Rivastigmine HEXAL 4.5 mg hard capsules Rivastigmine HEXAL 6 mg hard capsules
Danish: Rivastigmine HEXAL 1,5 mg hårde kapsler Rivastigmine HEXAL 3 mg hårde kapsler Rivastigmine HEXAL 4,5 mg hårde kapsler Rivastigmine HEXAL 6 mg hårde kapsler
English: Use Rivastigmine HEXAL oral solution within 1 month of opening the bottle.
Danish: Rivastigmine HEXAL oral opløsning skal anvendes inden for 1 måned efter, at flasken er åbnet.
English: The secondary definition of response required a 4-point or greater improvement on the ADAS-Cog, no worsening on the CIBIC-Plus, and no worsening on the PDS.
Danish: Den sekundære definition af respons krævede en mindst 4-pointsforbedring af ADAS-Cog, ingen forværring af CIBIC-Plus og ingen forværring af PDS.
English: The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.
Danish: Kapsler og miksturen kan også anvendes til behandling af demens hos voksne patienter med Parkinsons sygdom.
English: Benzoic acid is a mild irritant to the skin, eyes and mucous membranes.
Danish: Benzoesyre er mildt irriterende for huden, øjnene og slimhinderne.
English: Uncommon (may affect up to 1 in 100 people) • Hyperactivity (high level of activity, restlessness)
Danish: Ikke almindelig (kan ramme op til 1 patient ud af 100) Hyperaktivitet (højt aktivitetsniveau, rastløshed)
English: Total patients studied Total patients with pre-defined AE(s) Tremor
Danish: Totalt antal patienter i studiet Totalt antal patienter med prædefinerede bivirkninger Tremor
English: Other medicines and Rivastigmine HEXAL
Danish: Anden medicin og Rivastigmine HEXAL
English: • Slow and fast heartbeat
Danish: Langsom og hurtig hjerterytme (puls)
English: • Swallow your medicine straight from the syringe.
Danish: • Indtag din medicin direkte fra doseringssprøjten.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER FOR SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Clinically relevant improvement in these studies was defined a priori as at least 4-point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10% improvement on the PDS.
Danish: Klinisk relevant forbedring var i disse undersøgelser på forhånd defineret som en mindst 4-pointsforbedring af ADAS-Cog, forbedring af CIBIC-Plus eller en forbedring på mindst 10% af PDS.
English: Additionally there have been post-marketing cases of dizziness, tremor, headache, somnolence, confusional state, hypertension, hallucinations and malaise.
Danish: Derudover har der været post-marketing-indberetninger om svimmelhed, tremor, hovedpine, somnolens, forvirringstilstand, hypertension, hallucinationer og utilpashed.
English: If you accidentally take more Rivastigmine HEXAL than you should, inform your doctor.
Danish: Hvis du ved en fejltagelse er kommet til at tage mere Rivastigmine HEXAL, end du har fået besked på, skal du sige det til din læge.
English: Table 2 Metabolism and nutrition disorders
Danish: Tabel 2 Metabolisme og ernæring
English: Therefore, the ability of patients with dementia on rivastigmine to continue driving or operating complex machines should be routinely evaluated by the treating physician.
Danish: Derfor bør rivastigmin-behandlede demenspatienters evne til fortsat at køre bil eller betjene indviklede maskiner løbende vurderes af den behandlende læge.
English: - if you are allergic to rivastigmine (the active substance in Rivastigmine HEXAL) or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er overfølsom over for rivastigmin (det aktive stof i Rivastigmine HEXAL) eller et af de øvrige indholdsstoffer i denne medicin (anført i pkt.
English: If treatment is interrupted for more than three days, it should be re-initiated at 1.5 mg twice daily to reduce the possibility of adverse reactions (e.g. vomiting).
Danish: Hvis behandlingen afbrydes i mere end tre dage, må behandlingen genoptages med 1,5 mg 2 gange daglig for at formindske muligheden for bivirkninger (f.eks. opkastninger).
English: Hyperhydrosis Allergic dermatitis (disseminated)
Danish: Hyperhidrose Allergisk kontakteksem (dissemineret)
English: - if you have, or have ever had, asthma or severe respiratory disease.
Danish: - hvis du har eller har haft astma eller en svær luftvejssygdom.
English: Risk Management Plan (RMP)
Danish: Risikohåndteringsplan
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALU/PVC BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS ALU/PVC-BLISTER
English: In more severe cases nicotinic effects might develop such as muscular weakness, fasciculations, seizures and respiratory arrest with possible fatal outcome.
Danish: I mere alvorlige tilfælde er der blevet observeret nikotinvirkninger, såsom muskelslaphed, muskeltrækninger, krampeanfald og respirationsophør med muligt dødeligt udfald.
English: Talk to your doctor before taking Rivastigmine HEXAL
Danish: Tal med din læge før du tager Rivastigmine HEXAL.
English: The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration.
Danish: De mest almindeligt rapporterede bivirkninger er gastrointestinale, inklusive kvalme (38 %) og opkastning (23 %), særligt under dosistitrering.
English: How to use this medicine
Danish: Brug af denne medicin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR ALU/PVC BLISTER
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL ALU/PVC-BLISTER
English: • Too much saliva and dehydration
Danish: For meget spyt, dehydrering
English: ADAS-Cog Rivastigmine
Danish: ADAS-Cog Rivastigmin
English: • Urinary incontinence (inability to retain adequate urine)
Danish: Urininkontinens (kan ikke holde tilstrækkelig mængde urin tilbage)
English: • Tell your caregiver that you are taking Rivastigmine HEXAL.
Danish: • Fortæl dine nærmeste, at du er i behandling med Rivastigmine HEXAL.
English: • Wipe the outside of the syringe with a clean tissue.
Danish: • Tør sprøjtens yderside af med rent papir.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE BETINGELSER OG KRAV TIL MARKEDSFØRINGSTILLADELSEN
English: Some people who have accidentally taken too much Rivastigmine HEXAL have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Danish: Nogle personer, som er kommet til at tage for meget Rivastigmine HEXAL, har oplevet kvalme, opkastning, diarré, forhøjet blodtryk og hallucinationer.
English: If you have to undergo surgery whilst taking Rivastigmine HEXAL, tell your doctor before you are given any anaesthetics, because Rivastigmine HEXAL may exaggerate the effects of some muscle relaxants during anaesthesia.
Danish: Hvis du skal opereres, mens du er i behandling med Rivastigmine HEXAL, skal du fortælle det til din læge, inden du får nogen form for bedøvende medicin, da Rivastigmine HEXAL kan forstærke effekten af muskelafslappende midler under bedøvelse.
English: One of the excipients in Rivastigmine HEXAL oral solution is sodium benzoate.
Danish: Et af hjælpestofferne i Rivastigmine HEXAL oral opløsning er natriumbenzoat.
English: The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson's disease treated with rivastigmine transdermal patches: agitation (common).
Danish: Følgende yderligere bivirkninger er blevet observeret i et studie af patienter med demens associeret med Parkinsons sygdom, som er blevet behandlet med rivastigmin-depotplaster: uro (almindelig).
English: Content of the pack and other information What Rivastigmine HEXAL contains
Danish: Pakningens indhold og yderligere oplysninger Rivastigmine HEXAL indeholder
English: Other side effects seen with transdermal patches and which may occur with the oral solution:
Danish: Andre bivirkninger, der er set med depotplaster, og som kan forekomme ved brug af oral opløsning:
English: If you forget to take Rivastigmine HEXAL
Danish: Hvis du har glemt at tage Rivastigmine HEXAL
English: ADCS-CGIC Rivastigmine
Danish: ADCS-CGIC Rivastigmin
English: In oral studies with male and female rats, no adverse effects of rivastigmine were observed on fertility or reproductive performance of either the parent generation or the offspring of the parents.
Danish: Ved peroral indgift af rivastigmin på han- og hunrotter blev der ikke observeret bivirkninger hvad angår fertilitet eller forplantningsdygtighed hos hverken forældregenerationen eller afkom af forældrene.
English: Oral studies in pregnant rats and rabbits gave no indication of teratogenic potential on the part of rivastigmine.
Danish: Undersøgelser på gravide rotter og kaniner med peroral indgift af rivastigmin gav ingen indikation af et teratogent potentiale.
English: • Severe confusion
Danish: Svær forvirring
English: Pre-defined adverse events that may reflect worsening of parkinsonian symptoms in patients with dementia associated with Parkinson's disease
Danish: Prædefinerede bivirkninger, der muligvis kan reflektere en forværring af Parkinsons symptomer hos patienter med demens, der er associeret med Parkinsons sygdom
English: Since bradycardia constitutes a risk factor in the occurrence of torsades de pointes, the combination of rivastigmine with torsades de pointes-inducing medicinal products such as antipsychotics i.e. some phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, methadone, pentamidine and moxifloxacine should be observed with caution and clinical monitoring (ECG) may also be required.
Danish: Da bradykardi udgør en risikofaktor ved forekomst af torsades de pointes, bør kombinationen af rivastigmin med torsades de pointes-inducerende lægemidler, såsom antipsykotika, dvs. visse phenothiaziner (chlorpromazin, levomepromazin), benzamider (sulpirid, sultoprid, amisulprid, tiaprid, veraliprid), pimozid, haloperidol, droperidol, cisaprid, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, metadon, pentamidin og moxifloxacin anvendes med forsigtighed, og klinisk monitorering (EKG) kan også være nødvendig.
English: - if you have, or have ever had, irregular or slow heartbeat.
Danish: - hvis du har eller har haft uregelmæssig eller langsom hjerterytme (puls).
English: What Rivastigmine HEXAL is and what it is used for What you need to know before you take Rivastigmine HEXAL How to take Rivastigmine HEXAL Possible side effects
Danish: Hvad er Rivastigmine HEXAL og hvad det bruges til Det du skal vide, før du begynder at tage Rivastigmine HEXAL Sådan skal du tage Rivastigmine HEXAL Bivirkninger
English: - if you have had a previous skin reaction suggestive of allergic contact dermatitis with rivastigmine.
Danish: - hvis du tidligere har haft en hudreaktion, der tyder på allergisk kontakteksem forårsaget af rivastigmin.
English: Fatigue and asthenia Gait disturbance Parkinson gait
Danish: Træthed og asteni Gangforstyrrelse Parkinson gangart
English: Oral solution Novartis Pharma GmbH Roonstrasse 25
Danish: Oral opløsning Novartis Pharma GmbH Roonstrasse 25
English: Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8).
Danish: Der skal udvises forsigtighed ved brug af rivastigmin til patienter med sygt sinussyndrom eller overledningsdefekter (sino-atrialt blok, atrio-ventrikulært blok) (jævnfør pkt.
English: Administration of rivastigmine oral solution with food delays absorption (tmax) by 74 min and lowers Cmax by 43% and increases AUC by approximately 9%.
Danish: Indgift af rivastigmin oral opløsningsammen med føde forsinker optagelsen (tmax) med 74 min, sænker Cmax med 43% og øger AUC med ca. 9%.
English: Not known (frequency cannot be estimated from the available data) • Allergic reaction where the patch was used, such as blisters or skin inflammation
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data) Allergisk reaktion hvor depotplaster blev brugt, som f.eks. blærer, hudinflammation