FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product contains 0.8 mmol (18.4 mg) sodium per vial and is administered in sodium chloride 9 mg/ml solution for injection (see section 6.6).
Danish: Dette lægemiddel indeholder 0,8 mmol (18,4 mg) natrium per hætteglas og administreres i natriumklorid 9 mg/ml infusionsopløsning (se pkt.
English: The number of vials to be diluted based on the individual patient's weight must be determined and removed from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature.
Danish: Baseret på den enkelte patients vægt bestemmes det antal hætteglas, der skal fortyndes, og hætteglassene tages ud af køleskabet cirka 20 minutter inden infusionen med henblik på at lade dem komme op i stuetemperatur.
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Danish: ANVENDELSESMÅDE Læs indlægsseddel inden brug
English: What Naglazyme contains
Danish: Naglazyme indeholder:
English: Very common symptoms of these infusion reactions were pyrexia, chills/rigors, rash, urticaria and dyspnoea.
Danish: Meget almindelige symptomer ved disse infusionsreaktioner var pyreksi, kulderystelser/rigor, udslæt, urtikaria og dyspnø.
English: Likewise, antibody development is not predictive of decreased efficacy although subjects with limited response in endurance parameters or urinary glycosaminoglycans (GAGs) tended to have higher peak anti-galsulfase titres than those with good response.
Danish: om end forsøgspersoner med begrænset respons med hensyn til udholdenhedsparametrene eller glykosaminoglykaner (GAG'er) i urin var tilbøjelige til at have højere maksimale anti-galsulfasetitre end personer med god respons.
English: For information on pre-treatment see section 4.4 and for further instructions see section 6.6.
Danish: 4.4, og for yderligere anvisninger se pkt.
English: Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: A volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion is to be withdrawn and discarded from a 250 ml infusion bag equal to the total volume of Naglazyme to be added.
Danish: Et volumen natriumklorid 9 mg/ml (0,9%) infusionsopløsning, lig med det totale volumen Naglazyme der skal tilføres, trækkes ud af en 250 ml infusionspose og kasseres.
English: Before dilution, each vial is to be inspected for particulate matter and discolouration.
Danish: Inden fortyndingen undersøges hvert hætteglas visuelt for partikler og misfarvning.
English: The volume of Naglazyme is to be slowly added to the sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Naglazyme volumenet tilføres langsomt til natriumklorid 9 mg/ml (0,9%) infusionsopløsningen.
English: Talk to your doctor if you have kidney or liver insufficiency.
Danish: Tal med din læge, hvis du har nedsat nyre- eller leverfunktion.
English: Common symptoms of infusion reactions were pruritus, vomiting, abdominal pain, nausea, hypertension, headache, chest pain, erythema, cough, hypotension, angioedema, respiratory distress, tremor, conjunctivitis, malaise, bronchospasm and arthralgia.
Danish: Almindelige symptomer på infusionsreaktioner var pruritus, opkastning, abdominalsmerter, kvalme, hypertension, hovedpine, brystsmerter, erytem, hoste, hypotension, angioødem, respirationsbesvær, tremor, konjunktivitis, ubehag, bronkospasme og artralgi.
English: A clear to slightly opalescent, and colourless to pale yellow solution.
Danish: En klar til let opaliserende og farveløs til bleggul opløsning.
English: Serious adverse reactions included laryngeal edema, apnoea, pyrexia, urticaria, respiratory distress, angioedema, asthma and anaphylactoid reaction.
Danish: Alvorlige bivirkninger inkluderede laryngealt ødem, apnø, pyreksi, urticaria, respirationsbesvær, angioødem, astma og anaylaktoid reaktion.
English: For Naglazyme, no clinical data on exposed pregnancies are available.
Danish: Der findes ingen kliniske data vedrørende gravide kvinder, der har været behandlet med Naglazyme.
English: Spinal or cervical cord compression
Danish: Spinal- eller rygmarvskompression
English: Sodium phosphate monobasic monohydrate Sodium phosphate dibasic heptahydrate Polysorbate 80
Danish: Natriumfosfat monobasisk monohydrat, Natriumfosfat dibasisk heptahydrat, Polysorbat 80,
English: Galsulfase is a recombinant form of human N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Danish: Galsulfase er en rekombinant form af human N-acetylgalactosamine 4-sulfatase og er fremstillet ved rekombinant DNA teknologi ved brug af pattedyrcellekultur fra ovarier fra kinesiske hamstre (Chinese Hamster Ovary - CHO).
English: EXPIRY DATE
Danish: Tidsfrist, dato
English: Conjunctivitis1, corneal opacity1
Danish: Konjunktivitis1, cornea-uklarhed1
English: Ear pain1, hearing impaired1
Danish: Ørepine1, nedsat hørelse1
English: See section 4.8 for how to report adverse reactions.
Danish: 4.8, hvordan bivirkninger indberettes
English: Specification,Pharmacovigilance Plan or risk minimisation activities
Danish: • når der modtages ny information, der kan have indflydelse på den gældende sikkerhedsspecifikation, pharmacovigilance-plan eller på risikominimeringsaktiviteter
English: The clear to slightly opalescent and colourless to pale yellow concentrate must be free of visible particles.
Danish: Det klare til let opaliserende og farveløse til bleggule koncentrat skal være fri for synlige partikler.
English: A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution contains 1 mg galsulfase.
Danish: ANGIVELSE AF AKTIV STOF/AKTIVE STOFFER Hver ml opløsning indeholder 1 mg galsulfase.
English: The most common symptoms of infusion associated reactions include fever, chills, rash, hives and shortness of breath.
Danish: De almindeligste symptomer på infusionsrelaterede reaktioner inkluderer feber, kulderystelser, udslæt, nældefeber og stakåndethed.
English: • Malaise
Danish: • Ubehag
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 infusionsvæsken skal fortyndes med natriumklorid 9 mg/ml (0,9%) infusionsopløsning ved brug af aseptisk teknik.
English: What Naglazyme looks like and contents of the pack
Danish: Naglazymes udseende og pakningsstørrelse
English: Abdominal pain1, umbilical hernia1, vomiting, nausea
Danish: Abdominalsmerter1, navlebrok1, opkastning, kvalme
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of concentrate for solution for infusion 6 vials of concentrate for solution for infusion 5 mg/5 ml
Danish: 1 hætteglas med koncentrat til infusionsvæske, opløsning 6 hætteglas med koncentrat til infusionsvæske, opløsning 5 mg/5 ml
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE Kun til engangsbrug
English: Galsulfase is recombinant human N-acetylgalactosamine 4-sulfatase produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
Danish: Galsulfase er en rekombinant form af human N-acetylgalactosamine 4-sulfatase og er fremstillet af genetisk udviklede celler fra ovarier fra kinesiske hamstre (Chinese Hamster Ovary - CHO).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Naglazyme 1 mg/ml concentrate for solution for infusion Galsulfase
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Naglazyme 1 mg/ml koncentrat til infusionsvæske, opløsning Galsulfase
English: NAME OF THE MEDICINAL PRODUCT Naglazyme 1 mg/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Naglazyme 1 mg/ml koncentrat til infusionsvæske, opløsning
English: EU/1/05/324/001 1 vial EU/1/05/324/002 6 vials
Danish: EU/1/05/324/002 6 hætteglas
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Danish: INFORMATION I BRAILLE-SKRIFT Fritaget fra krav om blindeskrift
English: Patients who present with an acute febrile or respiratory illness may need to have their Naglazyme infusions delayed.
Danish: Det kan være nødvendigt at udsætte Naglazyme-infusioner hos patienter med akut febril eller respiratorisk sygdom.
English: • Gastroenteritis
Danish: • Gastroenteritis (mave-tarmkatar)
English: The clear to slightly opalescent and colourless to pale yellow solution must be free of visible particles.
Danish: Den klare til let opaliserende og farveløse til bleggule opløsning skal være fri for synlige partikler.
English: • Cloudy eyes
Danish: • Uklare øjne
English: The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme afslutte undersøgelser i henhold til nedennævnte oversigt.
English: Pain1, chest pain1, rigors1, malaise1, pyrexia
Danish: Smerter1, brystsmerter1, rigor1, ubehag1, pyreksi
English: Areflexia1, headache
Danish: Arefleksi1, hovedpine
English: The most common adverse reactions were pyrexia, rash, pruritus, urticaria, chills/rigors, nausea, headache, abdominal pain, vomiting and dypsnoea.
Danish: De almindeligste bivirkninger var pyreksi, udslæt, pruritus, urticaria, kulderystelser/rigor, kvalme, hovedpine, abdominalsmerter, opkastning og dyspnø.
English: What you need to know before you are given this medicine
Danish: Det skal du vide, før du fårNaglazyme
English: Overall, one case of sleep apnoea was experienced from all clinical studies.
Danish: Alt i alt oplevedes der i alle de kliniske studier et enkelt tilfælde af søvnapnø.
English: • Rapid breathing
Danish: • Hurtig puls
English: Spinal/cervical cord compression (SCC) with resultant myelopathy is a known and serious complication that can be due to MPS VI.
Danish: Spinal-/rygmarvskompression (SCC, Spinal/cervical Cord Compression) med resulterende myelopati, er en kendt og alvorlig komplikation, som kan skyldes MPS VI. Der er efter markedsføringen rapporteret tilfælde, hvor patienter, som er behandlet med Naglazym, udviklede SCC eller oplevede forværring af deres SCC, som krævede kirurgisk dekompression.
English: • Decreased heart rate
Danish: • Langsom puls
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Clear type 1, 5 ml VIAL
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: The safety and efficacy of Naglazyme in patients with renal or hepatic insufficiency have not been evaluated (see section 5.2) and no alternative dose regimen can be recommended in these patients.
Danish: Sikkerheden og effekten af Naglazyme hos patienter med nyre- eller leverinsufficiens er ikke blevet evalueret (se pkt.
English: Dyspnoea1, nasal congestion1
Danish: Luftveje, thorax og mediastinum Dyspnø1, nasal kongestion1
English: • Low blood-oxygen
Danish: • Lavt indhold af ilt i blodet
English: Sodium phosphate monobasic, monohydrate
Danish: Natriumdihydrogenphosphatmonohydrat,
English: Angioeodema1, rash1, urticaria, pruritus Very Common Erythema
Danish: Angioødem1, udslæt1, urtikaria, pruritus
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: Tal med lægen, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel.
English: • Wheezing • Skin redness
Danish: • Hivende vejrtrækning • Hudrødme
English: What this medicine is and what it is used for What you need to know before you are given this medicine How this medicine is given
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Naglazyme Sådan får du Naglazyme Bivirkninger
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden
English: Pallor
Danish: PSURs
English: NAME OF THE MEDICINAL PRODUCT Naglazyme 1 mg/ml concentrate for solution for infusion Galsulfase
Danish: Naglazyme 1 mg/ml koncentrat til infusionsvæske, opløsning Galsulfase
English: MedDRA
Danish: Bleghed
English: • Skin paleness
Danish: • Bleg hud
English: Sodium phosphate dibasic, heptahydrate
Danish: Dinatriumphosphatheptahydrat,
English: • Tremor
Danish: • Rystelser
English: • breast cancer.
Danish: Brystkræft
English: • non-small-cell lung cancer.
Danish: Ikke-småcellet lungekræft
English: EMA/13030/2016 EMEA/H/C/003925
Danish: EU/1/15/1017/001 EU/1/15/1017/002 EU/1/15/1017/003
English: The active substance docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Danish: Docetaxel hører til gruppen af kræftmedicin, der kaldes taxoider.
English: Taxespira is used with cisplatin and 5-fluorouracil.
Danish: I kombination med cisplatin og 5-fluorouracil
English: The full EPAR and risk management plan summary for Taxespira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: This summary was last updated in 01-2016.
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: Taxespira docetaxel
Danish: Capecitabin
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Danish: Denne indlægsseddel findes på alle EU-/EØS-sprog på Det Europæiske Lægemiddelagenturs hjemmeside.
English: Previously known as Docetaxel Hospira UK Limited.
Danish: Hospira UK Limited Horizon,
English: For more information, see the summary of product characteristics.
Danish: Se produktresuméet for trastuzumab for yderligere oplysninger.
English: What measures are being taken to ensure the safe and effective use of Taxespira?
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Taxespira is available as a concentrate for solution for infusion (drip) into a vein and is given as a onehour infusion every three weeks.
Danish: Docetaxel indgives som en 1-times infusion hver 3. uge.
English: An antiinflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Taxespira infusion.
Danish: Du vil blive bedt om at tage en præmedicinering bestående af oralt kortikosteroid (for eksempel dexamethason) 1 dag før behandlingen med Taxespira.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: Hospira Deutschland GmbH Tel: + 49 (0) 89 43 77 77 0
English: How has Taxespira been studied?
Danish: Dette lægemiddel hedder Taxespira.
English: Taxespira is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Danish: Behandling med docetaxel bør gentages, når neutrofiltallet igen er ≥ 1.500 celler/mm
English: Other information about Taxespira
Danish: Brug af anden medicin sammen med Taxespira
English: It is not intended to provide practical advice on how to use Taxespira.
Danish: Det skal du vide, før du begynder at bruge Taxespira Brug ikke Taxespira
English: Taxespira contains the active substance docetaxel and is a ‘generic medicine'.
Danish: - Aktivt stof: docetaxel (som trihydrat).
English: For practical information about using Taxespira, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Er du i tvivl om anvendelsen af dette lægemiddel, så spørg lægen eller apotekspersonalet på hospitalet.
English: By keeping the skeleton intact the cells cannot divide and they eventually die.
Danish: Hvis der forekommer krystaller, må opløsningen ikke længere anvendes, men skal kasseres.
English: EPAR summary for the public
Danish: Almene symptomer og reaktioner på administrationsstedet
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Danish: Denne information vil give lægen mulighed for at vurdere, om det er nødvendigt at nedsætte din dosis.
English: Taxespira is used with prednisone or prednisolone (anti-inflammatory medicines);
Danish: Taxespira i kombination med prednison eller prednisolon er indiceret til behandling af patienter med hormonrefraktær metastatisk prostatakræft.
English: Taxespira is used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Danish: Anvendelse af docetaxel bør begrænses til afdelinger, der er specialiserede i administration af cytostatika og docetaxel bør kun gives under supervision af en speciallæge i onkologi (se pkt.
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects
Danish: Docetaxel har vist genotoksiske virkninger i ikke-kliniske studier og kan ændre fertiliteten hos hanner (se pkt.
English: Because Taxespira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Taxespira er et antineoplastisk stof, og ligesom andre potentielt toksiske stoffer skal det behandles med forsigtighed ved håndtering og tilberedning af opløsningerne med Taxespira.
English: How is Taxespira used?
Danish: Sådan skal du bruge Taxespira 4.
English: Further information can be found in the summary of the risk management plan.
Danish: Effektresultaterne er opsummeret i nedenstående tabel:
English: It can also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Danish: Der er ingen relevant anvendelse af Taxespira i den pædiatriske population til indikationerne brystkræft, ikke-småcellet lungekræft, prostatakræft, gastrisk karcinom samt hoved- og halskræft med undtagelse af type II og III lavt differentieret nasofaryngealt karcinom.
English: A risk management plan has been developed to ensure that Taxespira is used as safely as possible.
Danish: Profylaktisk G-CSF kan anvendes til at nedsættes risikoen for hæmatologiske toksiciteter.
English: Docetaxel blocks a stage of cell division, whereby the internal ‘skeleton' is dismantled to allow the cell to divide.
Danish: In vitro-studier har vist, at docetaxel ødelægger det mikrotubulære netværk i celler, som er essentielle for mitosen og cellulære funktioner i interfasen.
English: For more information on generic medicines, see the question-and-answer document here.
Danish: For opbevaringsforhold for det fortyndede lægemiddel, se pkt.
English: It can also be used with cisplatin (another cancer medicine) in patients who have not yet received any treatment for their cancer;
Danish: Taxespira i kombination med platinmidler til patienter, der ikke tidligere behandlet med kemoterapi
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Hospira UK Limited on 28 August 2015.
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse Hospira UK Limited
English: For more information about treatment with Taxespira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du får akutte problemer med lungerne (feber, åndenød eller hoste), eller de bliver værre, skal du straks fortælle det til lægen, apotekspersonalet på hospitalet eller sundhedspersonalet.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Taxespira, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: Det skal der tages højde for hos gravide og ammende kvinder, børn og patienter i højrisikogrupper såsom patienter med leversygdom eller epilepsi.
English: Taxespira is used with cisplatin and 5-fluorouracil (other cancer medicines);
Danish: Ved dosismodifikation af cisplatin og 5-fluoruracil henvises der til de tilsvarende produktresuméer.
English: No additional studies in humans were needed as Taxespira is a generic medicine that is given by infusion and contains the same active substance as Taxotere.
Danish: Derimod kræver svære overfølsomhedsreaktioner såsom svær hypotension, bronkospasme eller generaliseret udslæt/erythem, øjeblikkelig afbrydelse af docetaxel-infusion og passende terapi.
English: The Committee recommended that Taxespira be approved for use in the EU.
Danish: Taxespira vil blive indgivet til dig af sundhedspersonalet.
English: The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: • head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread).
Danish: • ardannelse og fortykkelse i lungerne sammen med stakåndethed (lungefibrose)
English: The company provided data from the published literature on docetaxel.
Danish: Tilfælde af cystoidt makulaødem (CMO) er blevet rapporteret hos patienter, der blev behandlet med docetaxel.
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Danish: Taxespira i kombination med cisplatin og 5-fluoruracil er indiceret til behandling af patienter med metastatisk gastrisk adenokarcinom, inklusive adenokarcinom i den gastroøsofageale forbindelse, som ikke tidligere har fået kemoterapi mod metastatisk sygdom.
English: The company also showed that Taxespira solution for infusion has comparable quality to that of Taxotere.
Danish: For docetaxel-/carboplatin-kombinationen kunne der hverken bevises en ækvivalent eller noninferior effekt sammenlignet med referencebehandlingen kombinations-VCis.
English: Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk.
Danish: Overordnet demonstrerer resultaterne fra studierne en positiv benefit/risiko-fordeling for TAC sammenlignet med FAC.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Taxespira has been shown to be comparable to Taxotere.
Danish: Performance status-skalaen (underskalaerne for hoved og hals [PSS-HN]), som blev udformet med henblik på at måle forståeligheden af tale, evnen til at spise offentligt samt kostens normalitet, var signifikant til fordel for TPF sammenlignet med PF.
English: Taxespira can be used on its own after other treatments have failed.
Danish: Bivirkningerne af Taxespira kan blive mere alvorlige, når det gives i kombination med andre kemoterapeutiske midler.
English: Date of first authorisation: 04 December 1998 Date of latest renewal: 21 May 2008
Danish: Dato for første markedsføringstilladelse: 4. december 1998 Dato for seneste fornyelse: 21. maj 2008
English: It is not known if this occurs in humans.
Danish: Det vides ikke om dette sker i mennesker.
English: - if you have ever had an allergic reaction to a similar type of medicine (carbamate derivatives).
Danish: - hvis du nogensinde har haft en allergisk reaktion over for en lignende type medicin (carbamatderivater).
English: • Changes in tests which show how well the liver is working
Danish: • Ændringer i tests, som viser hvor godt leveren fungerer
English: 95% CI p-value
Danish: DLSM 95% CI p-værdi
English: Prometax can be used with food, drink and alcohol.
Danish: Prometax kan anvendes sammen med mad, drikke og alkohol.
English: • The patch can be used in everyday situations, including bathing and during hot weather.
Danish: • Plasteret kan anvendes i hverdagssituationer, herunder badning og varmt vejr.
English: Source: Study D2340-Table 11-6 and Table 11-7
Danish: Kilde: D2340-studiet tabel 11-6 and tabel 11-7