natgillin/translations-raw huggingface dataset:
15 Hvis der er behov for højere doser end 500 mg morphinækvivalent, anbefales det at revurdere opioid - behandlingen.
If higher dosages than 500 mg morphine-equivalent are needed, a reassessment of opioid-therapy is recommended.
4. 8).
Corrective treatment may often be required (see section 4.8).
4. 5).
The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended (see also section 4.5).
Gennembrudssmerter I undersøgelser har det vist sig, at næsten alle patienter til trods for behandling med et fentanylplaster fik behov for supplerende behandling med stærkt virkende lægemidler med konventionel udløsning til at standse gennembrudssmerter.
Breakthrough pain Studies have shown that almost all patients, despite treatment with a fentanyl patch, require supplemental treatment with potent rapid-release medicinal products to arrest breakthrough pain.
Respirationsdepression Som med alle potente opioider kan nogle patienter få respirationsdepression af Fentanyl- ratiopharm, og patienterne skal være under observation for denne virkning.
15 As with all potent opioids some patients may experience respiratory depression with Fentanyl- ratiopharm, and patients must be observed for this effect.
Kronisk lungesygdom Hos patienter med kronisk obstruktiv lungesygdom eller andre sygdomme i lungerne kan fentanyl give mere alvorlige bivirkninger, og denne patientgruppen kan få nedsat respiratorisk drive og øget modstand i luftvejene.
Chronic pulmonary disease In patients with chronic obstructive or other pulmonary diseases fentanyl may have more severe adverse reactions, in such patients opioids may decrease respiratory drive and increase airway resistance.
Afhængighed Tolerance og fysisk og psykologisk afhængighed kan opstå efter gentagen administration af opioider, men forekommer sjældent under behandling af cancersmerter.
Drug dependence Tolerance and physical and psychological dependence may develop upon repeated administration of opioids, but is rare in treatment of cancer related pain.
Øget intrakranielt tryk Fentanyl- ratiopharm bør anvendes med forsigtighed til patienter, som kan være særligt følsomme over for de intrakranielle virkninger af CO2- retention – fx patienter med dokumenteret øget intrakranielt tryk, nedsat bevidsthedsniveau eller koma.
Increased intracranial pressure Fentanyl-ratiopharm should be used with caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure, impaired consciousness or coma.
Kardielle lidelser Opioider kan medføre hypotension, især hos patienter med hypovolæmi, og der bør udvises forsigtighed ved behandling af patienter med hypotension og/ eller hypovolæmi.
Caution should therefore be taken in treatment of patients with hypotension and/ or patients with hypovolemia.
Fentanyl kan give bradykardi, og Fentanyl- ratiopharm bør administreres med forsigtighed til patienter med bradyarytmi.
Fentanyl-ratiopharm should be administered with caution to patients with bradyarrhythmias.
Nedsat leverfunktion Fentanyl metaboliseres til inaktive metabolitter i leveren, og patienter med leversygdom kan derfor have forsinket elimination.
Impaired liver function Fentanyl is metabolised to inactive metabolites in the liver, so patients with hepatic disease might have a delayed elimination.
Nedsat nyrefunktion Under 10% af fentanyl udskilles uomdannet via nyrerne, og til forskel fra morphin udskilles ingen kendte aktive metabolitter via nyrerne.
Renal impairment Less than 10% of fentanyl is excreted unchanged by the kidneys, and unlike morphine, there are no known active metabolites eliminated by the kidneys.
Data vedrørende intravenøst fentanyl hos patienter med nyresvigt tyder på, at fentanyls fordelingsvolumen ændres af dialyse, hvilket kan påvirke serumkoncentrationen.
This may affect serum concentrations.
16 Feber/ ekstern varmepåvirkning I tilfælde af feber bør patienten monitoreres for opioide bivirkninger, da væsentlige stigninger i legemstemperaturen indebærer en risiko for øget absorptionshastighed af fentanyl.
Therefore patients who develop fever should be monitored for opioid adverse reactions.
Plasterets applikationssted må ikke udsættes for varme fra eksterne varmekilder, fx sauna.
The patch application site should not be exposed to heat from external heat sources, e. g. sauna.
Ældre Data fra intravenøse forsøg med fentanyl tyder på, at ældre patienter kan have nedsat clearance og forlænget halveringstid, og at de desuden kan være mere følsomme over for det aktive stof end yngre patienter.
Moreover elderly patients may be more sensitive to the active substance than younger patients.
Pædiatriske patienter Erfaring med behandling af børn under 12 år er begrænset, og Fentanyl- ratiopharm bør kun anvendes til denne patientgruppe efter en nøje afvejning af fordele og risici.
Paediatric patients Due to limited experience in children under 12 years of age, Fentanyl-ratiopharm should be used in this age group only after careful consideration has been given to the benefit versus risk ratio.
4. 6).
16 Lactation As fentanyl is excreted into breast milk, lactation should be discontinued under treatment with Fentanyl-ratiopharm (see also section 4.6).
Patienter med myasthenia gravis Ikke- epileptiske (myo) klone reaktioner kan forekomme.
Patients with myasthenia gravis Non-epileptic (myo)clonic reactions can occur.
4. 5).
Interactions Combination with barbituric acid derivatives, buprenorphine, nalbuphine and pentazocine should in general be avoided (see section 4.5).
4. 4).
They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients (see also section 4.4).
Samtidig brug af andre CNS- deprimerende farmaka kan øge depressionen af centralnervesystemet og føre til hypoventilation, hypotoni samt kraftig sedation eller koma.
The concomitant use of other CNS depressants may produce additive depressant effects and hypoventilation, hypotension as well as profound sedation or coma may occur.
Det drejer sig bl. a. om følgende CNS- deprimerende farmaka:
The CNS depressants mentioned above include:
- opioider
- opioids
- anxiolytika og sedativa
- anxiolytics and tranquilizers
- hypnotika
- hypnotics
- generelle anæstetika
- general anaesthetics
- phenothiaziner
- phenothiazines
- muskelrelaksantia
- skeletal muscle relaxants
- sederende antihistaminer
- sedating antihistamines
- alkoholiske drikke
- alcoholic beverages
Det er rapporteret, at MAO- hæmmere kan øge virkningen af opioidanalgetika hos patienter med hjertesvigt.
MAO-inhibitors have been reported to increase the effect of narcotic analgesics, especially in patients with cardiac failure.
Fentanyl må derfor ikke anvendes inden for 14 dage efter seponering af behandling med MAO- hæmmere.
Therefore, fentanyl should not be used within 14 days after discontinuation of treatment with MAO-inhibitors.
17 Fentanyl er et aktivt stof med høj clearance, som metaboliseres hurtigt og i omfattende grad, hovedsageligt via CYP3A4.
Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.
Peroral administration af itraconazol, som er en stærkt virkende CYP3A4- hæmmer, i døgndoser på 200 mg i fire dage havde ingen signifikant virkning på fentanyls farmakokinetik efter intravenøs brug.
Itraconazole (a potent CYP3A4 inhibitor) at 200 mg/ day given orally for four days had no significant effect on the pharmacokinetics of intravenous fentanyl.
Efter peroral administration af ritonavir, som er en af de stærkest virkende CYP3A4- hæmmere, nedsattes clearance af intravenøst fentanyl med to tredjedele, og halveringstiden fordobledes.
Oral administration of ritonavir (one of the most potent CYP3A4 inhibitors) reduced the clearance of intravenous fentanyl by two thirds and doubled the half- life.
Samtidig brug af stærkt virkende CYP3A4- hæmmere (fx ritonavir) og transdermalt administreret fentanyl kan give øget plasma - koncentration af fentanyl.
Concomitant use of potent CYP3A4-inhibitors (e. g. ritonavir) with transdermally administered fentanyl may result in increased plasma concentrations of fentanyl.
Kombinationsbehandling med ritonavir eller en anden stærkt virkende CYP3A4- hæmmer og transdermalt fentanyl frarådes, med mindre patienten observeres nøje.
Combined use of ritonavir or other potent CYP3A4-inhibitors with transdermal fentanyl is not recommended, unless the patient is carefully observed.
Fentanyls sikkerhed under graviditet er ikke fastlagt.
17 The safety of fentanyl in pregnancy has not been established.
Fentanyl udskilles i modermælk og kan medføre sedation og respirationsdepression hos brystbarnet.
Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breast- fed infant.
Derfor bør amningen indstilles i mindst 72 timer efter fjernelse af Fentanyl- ratiopharm.
Lactation should therefore be discontinued during treatment and for at least 72 hours after the removal of Fentanyl-ratiopharm (see also section 4.4)
Fentanyl- ratiopharm påvirker i væsentlig grad evnen til at føre motorkøretøj eller betjene maskiner.
Fentanyl-ratiopharm has major influence on the ability to drive and use machines.
Eventuelle bivirkninger angives opdelt efter hyppighed:
The following frequencies are used for the description of the occurrence of adverse reactions:
Meget almindelige (> 1/ 10), almindelige (≥1/ 100 til < 1/ 10), ikke almindelige (≥1/ 1. 000 til < 1/ 100), sjældne (≥1/ 10. 000 til < 1/ 1. 000) og meget sjældne (< 1/ 10. 000).
Very common (≥ 1/ 10), Common (≥ 1/ 100, < 1/ 10), Uncommon (≥ 1/ 1000, < 1/ 100), Rare (≥ 1/ 10,000, < 1/ 1000), Very rare (< 1/ 10,000)
Hjerte Ikke almindelige:
Cardiac disorders Uncommon: tachycardia, bradycardia.
Sjældne:
Rare: arrhythmia.
Takykardi, bradykardi.
Nervous system disorders Very common: headache, dizziness.
Arytmi.
Uncommon: tremor, paraesthesia, speech disorder.
Meget almindelige:
ataxia, seizures (including clonic and grand mal seizures).
Ikke almindelige:
Eye disorders
Hovedpine, svimmelhed.
amblyopia.
Tremor, paræstesi, taleforstyrrelser.
Very rare:
Ataksi, epileptiske anfald (inklusive kloniske og tonisk- kloniske krampeanfald).
respiratory depression, apnoea.
Øjne Meget sjældne:
Common:
Amblyopi.
xerostomia, dyspepsia.
Luftveje, thorax og mediastinum Ikke almindelige:
Rare: hiccup.
Dyspnø, hypoventilation.
painful flatulence, ileus.
Respirationsdepression, apnø.
Very rare:
Mave- tarmkanalen
cystalgia, oliguria.
18
18 Common:
Almindelige:
skin reactions on the application site.
Diaré.
Uncommon: exanthema, erythema.
Smertefuld flatulens, ileus.
Rash, erythema and pruritus will usually disappear within one day after the patch has been removed.
Nyrer og urinveje Ikke almindelige:
Vascular disorders Uncommon: hypertension, hypotension.
Meget sjældne:
Rare: vasodilatation.
Smerter i urinblæren, oliguri.
General disorders and administration site conditions Rare: oedema, cold feeling.
Ikke almindelige:
Immune system disorders Very rare:
Eksantem, erytem.
anaphylaxis.
Hypertension, hypotension.
Psychiatric disorders Very common: somnolence.
Sjældne:
Common:
Ødemer, kuldefornemmelse.
sedation, nervousness, loss of appetite.
Ikke almindelige:
Uncommon: euphoria, amnesia, insomnia, hallucinations, agitation.
Ikke kendt (kan ikke estimeres ud fra forhåndenværende data):
Other undesirable effects Not known (cannot be estimated from the available data):
Under langtidsanvendelse af fentanyl kan der udvikles tolerance og fysisk og psykologisk afhængighed.
Long-term use of fentanyl can lead to development of tolerance and physical and psychological dependence.
Symptomer på opioidabstinenser (fx kvalme, opkastning, diaré, angst og kuldegysninger) kan forekomme hos patienter efter skift fra de hidtil anvendte opioidanalgetika til Fentanyl- ratiopharm eller efter brat seponering af lægemidlet.
After switching from previously prescribed opioid analgesics to Fentanyl-ratiopharm or after abrupt discontinuation of therapy patients may show opioid withdrawal symptoms (for instance: nausea, vomiting, diarrhoea, anxiety and shivering).
Symptomer Symptomerne på overdosering af fentanyl er forstærkede farmakologiske virkninger som fx apati, koma, respirationsdepression med Cheyne- Stokes respiration og/ eller cyanose.
Symptoms The symptoms of fentanyl overdose are an extension of its pharmacological actions, e. g. lethargy, coma, respiratory depression with Cheyne-Stokes respiration and/ or cyanosis.
Behandling Til behandling af respirationsdepression skal der omgående træffes forholdsregler, der omfatter fjernelse af plasteret og fysisk eller verbal stimulering af patienten.
Treatment For management of respiratory depression immediate countermeasures should be started, including removing the patch and physically or verbally stimulating the patient.
19 Til voksne anbefales en startdosis på 0, 4- 2 mg naloxonhydrochlorid i. v.
A starting dose of 0.4-2 mg naloxone hydrochloride i. v. is recommended for adults.
Efter behov kan der gives en tilsvarende dosis hvert 2. - 3. minut, eller der kan gives en kontinuerlig infusion af 2 mg i 500 ml isotonisk natriumchlorid injektionsvæske 9 mg/ ml (0, 9%) eller isotonisk glucose 5 mg/ ml (5%).
If needed, a similar dose can be given every 2 or 3 minutes, or be administered as continued infusion as 2 mg in 500 ml sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution.
Det er vigtigt, at intensivafdelingsbehandlingen finder sted, hvis patientens kliniske tilstand kræver det.
Intensive care unit treatment is important, if required by the patient’ s clinical condition.
I tilfælde af alvorlig eller vedvarende hypotension kan der være tale om hypovolæmi, og tilstanden skal behandles med passende parenteral væsketerapi.
If severe or persistent hypotension occurs, hypovolemia should be considered, and the condition should be managed with appropriate parenteral fluid therapy.
ATC- kode:
Pharmacotherapeutic group: opioids; Phenylpiperidine derivatives, ATC code:
Fentanyl er et opioidanalgetikum, der overvejende påvirker µ- receptoren.
Fentanyl is an opioid analgesic which interacts predominantly with the µ-receptor.
En øget bivirkningsincidens kan observeres, hvis niveauet i serum overstiger 2 ng/ ml.
The serum concentrations of fentanyl that cause a minimal analgesic effect in opioid-naive patients fluctuate between 0.3– 1.5 ng/ ml; an increased incidence of adverse reactions is observed if serum levels exceed 2 ng/ ml.
Efter administration af Fentanyl- ratiopharm absorberes fentanyl kontinuerligt gennem huden over 72 timer.
Following administration of Fentanyl-ratiopharm, fentanyl is continuously absorbed through the skin over a period of 72 hours.
Absorption Efter første applikation af Fentanyl- ratiopharm øges serumkoncentrationen gradvist, idet den generelt udjævnes efter 12- 24 timer, hvorefter den holder sig temmelig konstant i resten af den 72 timers applikationsperiode.
Absorption After the first application of Fentanyl-ratiopharm, serum fentanyl concentrations increase gradually, generally levelling off between 12 and 24 hours, and remaining relatively constant for the remainder of the 72-hour application period.
I praksis nås steady- state serumkoncentration ved den anden applikation af et 72- timers plaster og opretholdes under de efterfølgende applikationer af plastre med samme størrelse.
For all practical purposes by the second 72-hour application, a steady state serum concentration is reached and is maintained during subsequent applications of a patch of the same size.
Fordeling Bindingen til plasmaproteiner er 84%.
Distribution The plasma protein binding for fentanyl is 84%.
Biotransformation Fentanyl metaboliseres hovedsageligt i leveren via CYP3A4.
Biotransformation Fentanyl is metabolized primarily in the liver via CYP3A4.
50% i løbet af henholdsvis 13- 22 timer hos voksne og 22- 25 timer hos børn.
Elimination When treatment with Fentanyl-ratiopharm is withdrawn, serum fentanyl concentrations decline gradually, falling approximately 50% in 13-22 hours in adults or 22-25 hours in children, respectively.
Omkring 75% af fentanyl udskilles i urinen hovedsageligt som metabolitter, mens under 10% udskilles som uomdannet aktivt stof.
Around 75% of fentanyl is excreted into the urine, mostly as metabolites, with less than 10% as unchanged active substance.
Omkring 9% af dosis genfindes i fæces hovedsageligt som metabolitter.
About 9% of the dose is recovered in the faeces, primarily as metabolites.
20 Særlige populationer Ældre og svækkede patienter kan have nedsat clearance af fentanyl, hvilket forlænger den terminale halveringstid.
Pharmacokinetics in special groups Elderly and debilitated patients may have reduced clearance of fentanyl leading to prolonged terminal half life.
Hos patienter med nedsat nyre - eller leverfunktion kan der ske forandringer i clearance af fentanyl på grund af ændringer i plasmaproteiner og metabolisk clearance, der fører til forhøjet serumkoncentration.
In patients with renal or hepatic impairment, clearance of fentanyl may be altered because of changes of plasma proteins and metabolic clearance resulting in increased serum concentrations.
Klæbelag Klæbelag af polyacrylat
Adhesive layer Polyacrylate adhesive layer
Bagsidefolie Polypropylenfolie Blåt blæk
Backing film Polypropylene foil Blue printing ink
Beskyttelsesfolie Polyethylenterephthalatfolie (silikonebehandlet)
Release liner Polyethylene terephthalate foil (siliconised)
Depotplastrene er pakket hver for sig i breve.
Each transdermal patch is packed in a separate sachet.
Kompositfolien indeholder følgende lag udefra og ind: overtrukket Kraft- papir, lavdensitets polyethylenfilm, aluminiumsfolie, Surlyn (termoplastisk ethylen - metha- acrylsyre copolymer).
The Composite foil containing the following layers from outside to inside: coated Kraft paper, low density polyethylene foil, aluminium foil, Surlyn (thermoplastic ethylene-methacrylic acid copolymer).
Efter brug vil der stadig være store mængder fentanyl tilbage i plastrene.
High quantities of fentanyl remain in the transdermal patches even after use.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
Any unused medicinal product should be discarded or returned to the pharmacy.
[Udfyldes nationalt]
21 [To be completed nationally]
DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/ FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORIZATION/ RENEWAL OF THE AUTHORIZATION
MM/ ÅR
{MM/ YYYY}
Fentanyl- ratiopharm 50 µg/ h Matrixpflaster og andre berørte navne (se Vedlæg I)
Fentanyl-ratiopharm 50 µg/ h Matrixpflaster and associated names (see Annex I)
1 depotplaster frigiver 50 mikrogram fentanyl i timen.
Each patch releases 50 micrograms fentanyl per hour.
1 plaster på 15 cm2 indeholder 8, 25 mg fentanyl.
Each patch of 15 cm2 contains 8.25 mg fentanyl.
Transparent og farveløst plaster med blåt tryk på bagsidefolien: “ fentanyl 50 µg/ h “.
Transparent and colourless patch with blue imprint on the backing foil: “ fentanyl 50 µg/ h“.
Den tilsvarende fentanyldosis fastsættes som følger: a) Ved hjælp af tabel 2 for patienter, som har behov for opioidrotation (med konvertering fra peroralt morphin til transdermalt fentanyl i forholdet 150: 1) b) Ved hjælp af tabel 3 for patienter på stabil og veltolereret opioidterapi (med konvertering fra peroralt morphin til transdermalt fentanyl i forholdet 100: 1)
The corresponding fentanyl dosage should be determined as follows: a) using Table 2 for patients who have a need for opioid rotation (conversion ratio of oral morphine to transdermal fentanyl equal to150:1) b) using Table 3 for patients on stable and well tolerated opioid therapy (conversion ratio of oral morphine to transdermal fentanyl equal to 100:1)
23 Tabel 1:
23 Table 1:
Peroral morphindosis (mg/ døgn)
dose (mg/ 24 h)
Transdermal frigivelse af fentanyl (mikrogram/ time)
Transdermal fentanyl release (micrograms/ h)
Peroral morphindosis (mg/ døgn) < 60
< 60
Transdermal frigivelse af fentanyl (mikrogram/ time) 12, 5
12.5
Ved at kombinere flere depotplastre kan der opnås en frigivelseshastighed for fentanyl på over 100 mikrogram i timen.
24 By combining several transdermal patches, a fentanyl release rate of over 100 micrograms/ h can be achieved.
25 Umiddelbart efter det er taget ud af pakningen og beskyttelsesfolien er fjernet, anbringes depotplasteret på et hårløst område af huden på overkroppen (bryst, ryg eller overarm).
Method of administration Directly after removal from the pack and the release liner, the patch is applied to a non-hairy area of skin on the upper body (chest, back, upper arm).
Hvis der er spor af plasteret på huden, efter at det er taget af, kan de fjernes med rigeligt vand og sæbe.
25 If traces of the transdermal patch remain on the skin after its removal, these can be cleaned off using copious amounts of soap and water.
26 Hvis der er behov for højere doser end 500 mg morphinækvivalent, anbefales det at revurdere opioid - behandlingen.
If higher dosages than 500 mg morphine-equivalent are needed, a reassessment of opioid-therapy is recommended.
Respirationsdepression Som med alle potente opioider kan nogle patienter få respirationsdepression af Fentanyl- ratiopharm, og patienterne skal være under observation for denne virkning.
26 As with all potent opioids some patients may experience respiratory depression with Fentanyl- ratiopharm, and patients must be observed for this effect.
27 Feber/ ekstern varmepåvirkning I tilfælde af feber bør patienten monitoreres for opioide bivirkninger, da væsentlige stigninger i legemstemperaturen indebærer en risiko for øget absorptionshastighed af fentanyl.
Therefore patients who develop fever should be monitored for opioid adverse reactions.
4. 6).
27 Lactation As fentanyl is excreted into breast milk, lactation should be discontinued under treatment with Fentanyl-ratiopharm (see also section 4.6).
28 Fentanyl er et aktivt stof med høj clearance, som metaboliseres hurtigt og i omfattende grad, hovedsageligt via CYP3A4.
Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.
Fentanyls sikkerhed under graviditet er ikke fastlagt.
28 The safety of fentanyl in pregnancy has not been established.
29
29 Common:
30 Til voksne anbefales en startdosis på 0, 4- 2 mg naloxonhydrochlorid i. v.
A starting dose of 0.4-2 mg naloxone hydrochloride i. v. is recommended for adults.
31 Særlige populationer Ældre og svækkede patienter kan have nedsat clearance af fentanyl, hvilket forlænger den terminale halveringstid.
Pharmacokinetics in special groups Elderly and debilitated patients may have reduced clearance of fentanyl leading to prolonged terminal half life.
[Udfyldes nationalt]
32 [To be completed nationally]
Fentanyl- ratiopharm 75 µg/ h Matrixpflaster og andre berørte navne (se Vedlæg I)
Fentanyl-ratiopharm 75 µg/ h Matrixpflaster and associated names (see Annex I)
1 depotplaster frigiver 75 mikrogram fentanyl i timen.
Each patch releases 75 micrograms fentanyl per hour.
1 plaster på 22, 5 cm2 indeholder 12, 375 mg fentanyl.
Each patch of 22.5 cm2 contains 12.375 mg fentanyl.
Transparent og farveløst plaster med blåt tryk på bagsidefolien: “ fentanyl 75 µg/ h “.
Transparent and colourless patch with blue imprint on the backing foil: “ fentanyl 75 µg/ h“.
34 Tabel 1:
34 Table 1:
35 Tabel 3:
Table 3:
Ved at kombinere flere depotplastre kan der opnås en frigivelseshastighed for fentanyl på over 100 mikrogram i timen.
35 By combining several transdermal patches, a fentanyl release rate of over 100 micrograms/ h can be achieved.
36 Umiddelbart efter det er taget ud af pakningen og beskyttelsesfolien er fjernet, anbringes depotplasteret på et hårløst område af huden på overkroppen (bryst, ryg eller overarm).
Method of administration Directly after removal from the pack and the release liner, the patch is applied to a non-hairy area of skin on the upper body (chest, back, upper arm).
Hvis der er spor af plasteret på huden, efter at det er taget af, kan de fjernes med rigeligt vand og sæbe.
36 If traces of the transdermal patch remain on the skin after its removal, these can be cleaned off using copious amounts of soap and water.