natgillin/translations-raw huggingface dataset:
Usædvanlig sløvhed eller træthed (nedsættende virkning på hjernefunktionen), nervøsitet, manglende appetit, mundtørhed, mavesmerter, hudreaktioner ved applikationsstedet.
Feeling unusually drowsy or tired (depressant effect on brain function), nervousness, loss of appetite, dry mouth, stomach pain, skin reactions at the attachment site.
Svære kroniske smerter, som kun kan lindres tilstrækkeligt med opioidanalgetika.
The product is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
4.6 i det foreslåede produktresumé: "Fentanyl udskilles med modermælk og kan medføre sedation og respirationsdepression hos det ammede barn.
Regarding breast-feeding, section 4.6 of the proposed SPC reads: “Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breastfed infant.
DATO FOR ÆNDRING AF TEKSTEN MM/ÅR [Udfyldes nationalt]
DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
Den serumkoncentration af fentanyl, der giver en minimal analgetisk virkning hos ikke-opioidbehandlede patienter, svinger mellem 0,3-1,5 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.
Fentanyl bør ikke anvendes under veer og fødsel (inklusive kejsersnit), da stoffet passerer placenta og kan medføre respirationsdepression hos nyfødte.
It is advised not to use fentanyl during labour and delivery (including caesarean section) since fentanyl passes the placenta and may cause respiratory depression in the new born infant.
- astma, åndedrætsbesvær eller anden lungesygdom - lavt blodtryk
- asthma, respiratory depression or any lung disease
Transdermal frigivelse af fentanyl (mikrogram/time)
Transdermal fentanyl release (micrograms/h)
Patienter med nedsat nyrefunktion, der får transdermalt fentanyl, skal observeres nøje for tegn på fentanyltoksicitet, og om nødvendigt reduceres dosis.
If patients with renal impairment receive transdermal fentanyl they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
Blåt blæk
Blue printing ink
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 breastfed infant.
Data vedrørende intravenøst fentanyl hos patienter med nyresvigt tyder på, at fentanyls fordelingsvolumen ændres af dialyse, hvilket kan påvirke serumkoncentrationen.
Data obtained with intravenous fentanyl in patients with renal failure suggest that the volume of distribution of fentanyl may be changed by dialysis.
Vrangforestillinger, ekscitation, asteni, depression, angst, konfusion, seksuel dysfunktion, abstinenssymptomer.
delusional ideas, states of excitement, asthenia, depression, anxiety, confusion, sexual dysfunction, withdrawal symptoms.
Derfor skal brugte depotplastre foldes med klæbesiden indad og destrueres eller eventuelt indleveres på apoteket.
Used transdermal patches should be folded with the adhesive surfaces inwards and discarded or whenever possible returned to the pharmacy.
Brug af Fentanyl-ratiopharm under fødslen (inklusive kejsersnit) frarådes, da fentanyl passerer moderkagen og kan medføre åndedrætsbesvær hos det nyfødte barn.
It is advised not to use Fentanyl-ratiopharm during labour and delivery (including caesarean section) because fentanyl may cause breathing problems in the newborn child.
Ludwig-Merkle-Str. 3 D-89143 Blaubeuren Tyskland
Manufacturer Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Germany
Andre symptomer på en overdosis er sløvhed, lav kropstemperatur, langsom hjerterytme, nedsat muskelspænding, dyb bedøvelse, tab af muskelkoordination (problemer med at kontrollere muskelbevægelser), sammentrækning af pupillerne og kramper.
Other signs and symptoms of overdose are drowsiness, low body temperature, slow heart rate, decreased muscle tone, deep sedation, loss of muscle co-ordination, constriction of the pupils and convulsions.
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 bliver udskilt i modermælk og kan give bivirkninger hos brystbarnet såsom sedation og svækket åndedræt.
Fentanyl passes into the breast-milk and may cause side effects in the breast-fed infant as sedation and respiratory depression.
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.
Eksantem, erytem.
Uncommon: exanthema, erythema.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt]
MARKETING AUTHORISATION NUMBERS [To be completed nationally]
Polypropylenfolie
Polypropylene foil
Dosistitrering og vedligeholdelsesbehandling
Dose titration and maintenance therapy
Ældre eller kakektiske patienter bør holdes under nøje observation, og om nødvendigt reduceres dosis.
Elderly or cachectic patients should be observed carefully and the dose reduced if necessary.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt] {Navn og adresse}
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and Address}
Tabel 3: Anbefalet initial dosis af transdermalt fentanyl baseret på daglig peroral morphindosis (for patienter på stabil og veltolereret opioidterapi) Peroral morphindosis (mg/døgn)
Table 3: Recommended initial dose of transdermal fentanyl based on daily oral morphine dose (for patients on stable and well tolerated opioid therapy)
Ændring eller afslutning af behandlingen
Changing or ending therapy
Sådan opbevarer De Fentanyl-ratiopharm Yderligere oplysninger
How to store Fentanyl-ratiopharm Further information
4.4 i produktresuméet: "Ved andre kroniske smerter end cancersmerter kan det være hensigtsmæssigt at indlede behandlingen med stærkt virkende opioider med umiddelbar frigivelse (f.eks. morphin) og først ordinere fentanyl depotplaster, efter at virkning og optimal dosering af stærkt virkende opioder er fastlagt."
The CHMP recommended also adding the following statement in section 4.4 of the SPC: “In chronic non-cancer pain, it might be preferable to initiate the treatment with immediate-release strong opoids (e.g. morphine) and to prescribe fentanyl transdermal patch after determination of the efficacy and the optimal dosage of the strong opioid.”
Generelt bør det undgås at kombinere fentanyl med barbitursyrederivater, buprenorphin, nalbuphin og pentazocin (se pkt.
Combination with barbituric acid derivatives, buprenorphine, nalbuphine and pentazocine should in general be avoided (see section 4.5).
3 depotplastre 5 depotplastre 10 depotplastre 20 depotplastre
3 transdermal patches 5 transdermal patches 10 transdermal patches 20 transdermal patches
Den langsomme reduktion i serumkoncentration i forhold til intravenøs infusion skyldes den fortsatte absorption af fentanyl fra huden.
Continued absorption of fentanyl from the skin accounts for a slower reduction in serum concentration than is seen after an intravenous infusion.
Det er vigtigt, at intensivafdelingsbehandlingen finder sted, hvis patientens kliniske tilstand kræver det. 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.
Usædvanlig opstemthed, hukommelsestab, søvnbesvær, hallucinationer, ophidselse, skælven, føleforstyrrelser, taleforstyrrelser, sænkning eller stigning i blodtryk og hjertefrekvens, åndenød, vandladningsbesvær, diaré, udslæt, rødmen (erytem).
Uncommon: Unnatural feeling of happiness, memory loss, difficulties in sleeping, hallucinations, agitation, tremor, sensitivity disturbances, speech disorders, fall or rise in the blood pressure and heart rate, difficulties in breathing, diarrhoea, difficulty in passing urine, skin rash, skin reddening (erythema).
- Fjern plasteret, når der er gået den tid, lægen har angivet.
How to change the transdermal patch - Remove the patch after the period your doctor has told you.
Ketobemidon Tabel 2: Anbefalet initialdosis af transdermalt fentanyl ud fra daglig peroral morphindosis (for patienter med behov for opioidrotation) Peroral morphindosis (mg/døgn)
Table 2: Recommended initial dose of transdermal fentanyl based on daily oral morphine dose (for patients who have a need for opioid rotation)
Fentanyl-ratiopharm kan have livstruende bivirkninger hos personer, der ikke regelmæssigt får opioider på recept.
Bear in mind that the design of this medicinal product could be tempting to a child. Fentanyl-ratiopharm can have life-threatening side-effects in persons that are not using prescribed opioid medicines on a regular basis.
Smerter i urinblæren, oliguri.
cystalgia, oliguria.
Tremor, paræstesi, taleforstyrrelser.
Uncommon: tremor, paraesthesia, speech disorder.
Opbevares utilgængeligt for børn.
is recommended for adults.
DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION [To be completed nationally]
- hvis De er overfølsom (allergisk) over for fentanyl eller et af de øvrige indholdsstoffer.
Do not use Fentanyl-ratiopharm - if you are hypersensitive (allergic) to fentanyl or any of the other ingredients of the product.
Psykiske forstyrrelser Meget almindelige:
Psychiatric disorders Very common: somnolence.
Håret fjernes med saks og må ikke barberes af.
To remove hair, scissors should be used instead of razors.
Hud og subkutane væv Meget almindelige:
Skin and subcutaneous tissue disorders Very common: sweating, pruritus.
Klæbelag af polyacrylat
Polyacrylate adhesive layer
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.
Data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life.
Diamorphin Pethidin Codein Buprenorphin
Diamorphine Pethidine
Fentanyl bør ikke gives samtidig med buprenorphin, nalbuphin eller pentazocin.
The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended.
Øjne Meget sjældne:
Eye disorders Very rare:
Efter brug foldes plastrene sammen på midten med klæbefladerne mod hinanden.
Used patches should be folded in half with the sticky sides together.
Hvis De holder op med at bruge Fentanyl-ratiopharm
If you stop using Fentanyl-ratiopharm
Hvis De har glemt at bruge Fentanyl-ratiopharm
If you forget to use Fentanyl-ratiopharm
anbefalede CHMP på grundlag af den dokumentation, der er forelagt af indehaveren af markedsføringstilladelsen, og den faglige drøftelse i udvalget udstedelse af de markedsføringstilladelse(r) og ændring af det produktresumé og den etikettering og indlægsseddel, der fremgår af bilag III, for Fentanyl "ratiopharm" og tilknyttede navne - se bilag I.
the CHMP has recommended the granting of the Marketing Authorisation(s) and the amendment of the Summary of Product Characteristics, labelling and package leaflet which are set out in Annex III for Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names (see Annex I).
De brugte plastre lægges tilbage i yderemballagen og bortskaffes eller indleveres om muligt på apoteket.
Put back used patches in the outer package and discard or whenever possible hand in to your pharmacist.
Abstinenssymptomer kan bestå i kvalme, opkastning, diaré og kuldegysninger.
Withdrawal symptoms may be nausea, vomiting, diarrhoea, anxiety and shivering.
Anvendelse til ældre Ældre bør observeres nøje, og doseringen reduceres efter behov (se pkt.
Use in elderly patients Elderly should be observed carefully and the dose reduced if necessary (see sections 4.4 and 5.2).
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 udskilles i modermælk, og amning bør derfor indstilles under behandling med Fentanylratiopharm (se også pkt.
As fentanyl is excreted into breast milk, lactation should be discontinued under treatment with Fentanyl-ratiopharm (see also section 4.6).
1 plaster på 15 cm2 indeholder 8,25 mg fentanyl.
Each patch of 15 cm2 contains 8.25 mg fentanyl.
Uregelmæssig hjerterytme (rytmeforstyrrelser), udvidede blodkar, hikke, vandophobning i væv, kuldefornemmelse.
Irregular heartbeat, dilated blood vessels, hiccup, water retention in the tissues, feeling cold.
Da ydersiden af depotplasteret er beskyttet af vandtæt folie, kan patienten have det på i brusebad.
As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.
1 plaster på 7,5 cm2 indeholder 4,125 mg fentanyl.
Each patch of 7.5 cm2 contains 4.125 mg fentanyl.
Fentanyl bør ikke anvendes samtidig med buprenorphin, nalbuphin eller pentazocin (se også pkt.
The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended (see also section
Kløen går normalt væk i løbet af et døgns tid, når plasteret tages af.
Itching will usually disappear within one day after the patch has been removed.
Aktivt stof
Active substance Parenteral (im) Oral
Nyrer og urinveje Ikke almindelige:
Renal and urinary disorders Uncommon: urinary retention.
- Da ydersiden af depotplasteret er beskyttet af vandtæt folie, kan patienten have det på i brusebad.
- As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.
1 plaster på 30 cm2 indeholder 16,5 mg fentanyl.
Each patch of 30 cm2 contains 16.5 mg fentanyl.
Tal med Deres læge, hvis De bliver gravid under behandlingen med Fentanyl ratiopharm depotplaster.
If you get pregnant during treatment with Fentanyl-ratiopharm, consult your doctor.
Eftersom indbringelsen vedrørte:
In this leaflet:
Derfor vil lægen måske give Dem ekstra smertemedicin, indtil Deres fentanyl depotplaster opnår sin fulde virkning.
Your first patch will start to work slowly, this may take as long as one day, so your doctor may give you extra painkillers until your fentanyl transdermal patch starts working completely.
1 plaster på 22,5 cm2 indeholder 12,375 mg fentanyl.
Each patch of 22.5 cm2 contains 12.375 mg fentanyl.
Udslæt og rødmen går normalt væk i løbet af et døgns tid, når plasteret tages af.
Skin rash and skin reddening will usually disappear within one day after the patch has been removed.
- Find et jævnt, ubestrålet område på overkroppen eller overarmen, hvor huden er fri for hår, småsår, knopper eller andre uregelmæssigheder.
How to apply Fentanyl-ratiopharm - Find a flat part of your upper body (trunk) or upper arm, where the skin is without hair, cuts, spots or other skin blemishes.
Svedudbrud, pruritus.
Very common: sweating, pruritus.
12.375 mg/22.5 cm² som frigiver 75 mikrogram per time
75 µg/h transdermal patch transdermal use 12.375 mg/22.5 cm² which release 75 µg fentanyl per hour
Patienter med nedsat lever- eller nyrefunktion bør observeres nøje, og dosis reduceres efter behov (se pkt.
Patients with hepatic or renal impairment should be observed carefully and the dose reduced if necessary (see section 4.4).
Anafylaksi.
arrhythmia.
Afhængighed
Drug dependence
Det brugte plaster foldes sammen og smides ud eller afleveres på apoteket.
Fold used patches and discard or return to the pharmacy.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 depotplaster
PHARMACEUTICAL FORM AND CONTENTS 1 transdermal patch
Hovedpine, svimmelhed.
Very common: headache, dizziness.
Virkningen vil være længere om at indtræffe efter en intramuskulær eller subkutan injektion end efter intravenøs administration.
Following intramuscular or subcutaneous administration the onset of action will be slower compared with intravenous administration.
Endelig må dosisproportionalitet forventes, da Fentanyl "ratiopharm" er et matrixplaster, fra hvilket afgivelsen er proportional med overfladearealet.
Finally, since Fentanyl ratiopharm is a matrix patch for which the release is proportional to the surface area, dose proportionality is expected and a bioequivalence study with the highest strength is not deemed necessary, nor an additional replicate design study.
Nedsat nyrefunktion
Impaired liver function
Patienter med nedsat leverfunktion bør holdes under nøje observation, og om nødvendigt reduceres dosis.
Patients with hepatic impairment should be observed carefully and the dose reduced if necessary.
[20 depotplastre:] Dato
[20 transdermal patches:] Date
De får Fentanyl-ratiopharm - medicin mod søvnforstyrrelser (hypnotika, sedativa) - medicin til behandling af allergi eller transportsyge (antihistaminer/antiemetika) - andre stærkt virkende smertestillende midler (opioider) - alkohol
This applies, for example, to: - medicines used for treating anxiety (tranquillisers) - medicines used for treating depression (antidepressants) - medicines used for treating psychological disorders (neuroleptics) - anaesthetics, if you think you are going to have an anaesthetic, tell the doctor or dentist that you are using Fentanyl-ratiopharm - medicines used for treating sleep disorders (hypnotics, sedatives) - medicines used for treating allergies or travel sickness (antihistamines/antiemetics) - other strong-acting painkillers (opioids) - alcohol
Bevidsthedssvækkelse, hovedpine, svimmelhed, kvalme, opkastning, forstoppelse, svedudbrud, kløe.
Very common: Somnolence, headache, dizziness, nausea, vomiting, constipation, sweating, itching.
Spørg lægen eller apoteket, hvis der er noget, De er i tvivl om eller følger Dem usikker på.
You should check with your doctor or pharmacist if you are not sure.
16.5 mg/30 cm² som frigiver 100 mikrogram per time
100 µg/h transdermal patch transdermal use 16.5 mg/30 cm² which release 100 µg fentanyl per hour
1 depotplaster frigiver 100 mg fentanyl i timen.
Each patch releases 100 micrograms fentanyl per hour.
[5 depotplastre:] Dato
[5 transdermal patches:] Date
4.125 mg/7.5 cm² som frigiver 25 mikrogram per time
25 µg/h transdermal patch transdermal use 4.125 mg/7.5 cm² which release 25 µg fentanyl per hour
De må ikke anvende disse lægemidler sammen med Fentanylratiopharm, da det kan øge deres giftige virkning (toksicitet).
If these medicines are taken together this may enhance their toxicity.
De kan blive utilpas, hvis De stopper brugen af plastrene.
If you do stop using the patches you may feel unwell.
8.25 mg/15 cm² som frigiver 50 mikrogram per time
50 µg/h transdermal patch transdermal use 8.25 mg/15 cm² which release 50 µg fentanyl per hour
Vær ekstra forsigtig med at bruge Fentanyl-ratiopharm
Take special care with Fentanyl-ratiopharm
4.4 "sideløbende anvendelse anbefales ikke" i stedet for som en kontraindikation.
Therefore, the CHMP recommends that, according to the above mentioned guideline, this aspect should be mentioned in section 4.5 of the SPC with cross reference to section 4.4 “concomitant use not recommended” rather than a contra-indication.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 depotplaster frigiver 100 mikrogram fentanyl i timen.
STATEMENT OF ACTIVE SUBSTANCE(S) Each patch releases 100 micrograms fentanyl per hour.
1 depotplaster frigiver 75 mg fentanyl i timen.
Each patch releases 75 micrograms fentanyl per hour.
Fentanyl-ratiopharm 100 µg/h TTS og andre berørte navne (se Vedlæg I)
Fentanyl-ratiopharm 100 µg/h TTS and associated names (see Annex I)
[3 depotplastre:] Dato
[3 transdermal patches:] Date
Klæbelag: Klæbelag af polyacrylat
Polyacrylate adhesive layer Polypropylene foil
KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 depotplaster frigiver 100 mikrogram fentanyl i timen.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 100 micrograms fentanyl per hour.
Luftveje, thorax og mediastinum Ikke almindelige:
Respiratory, thoracic and mediastinal disorders Uncommon: dyspnoea, hypoventilation.
[10 depotplastre:] Dato
[10 transdermal patches:] Date
Merckle GmbH
Transdermal patch
Urinretention.
anaphylaxis.
SÅDAN SKAL DE BRUGE FENTANYL-RATIOPHARM
HOW TO USE Fentanyl-ratiopharm
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 depotplaster frigiver 25 mikrogram fentanyl i timen.
STATEMENT OF ACTIVE SUBSTANCE(S) Each patch releases 25 micrograms fentanyl per hour.
SÅDAN OPBEVARER DE FENTANYL-RATIOPHARM
HOW TO STORE Fentanyl-ratiopharm
CHMP tilsluttede sig, at stærkt virkende opioider under særlige omstændigheder kan tænkes at være til gavn til denne indikation.
Besides controversial literature results on the efficacy and safety of fentanyl transdermal in chronic non cancer pain, the CHMP recognised that, in special circumstances, strong opioids could be of help for the treatment of this condition.
Nervesystemet Meget almindelige:
Nervous system disorders
KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 depotplaster frigiver 75 mikrogram fentanyl i timen.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 75 micrograms fentanyl per hour.
1 depotplaster frigiver 25 mg fentanyl i timen.
Each patch releases 25 micrograms fentanyl per hour.
Transparent og farveløst plaster med blåt tryk på bagsidefolien: “fentanyl 100 µg/h“.
Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 100 µg/h“.
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).
Fentanilo Matrix ratiomed 100microgramos/h parches transdérmicos EFG Storbritannien Ribofen 100 microgram/hr Transdermal patch Tyskland
Fentanyl-ratio 100µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 100, pleister voor transdermaal gebruik 100 µg/uur United Kingdom Ribofen 100 microgram/hr Transdermal patch
Hvis De glemmer at skifte plasteret, skal De gøre det, så snart De kommer i tanke om det.
If you forget, then change your patch as soon as you remember.
6.7 Emballagetype og pakningsstørrelser Depotplastrene er pakket hver for sig i breve.
Each transdermal patch is packed in a separate sachet.
- Lægen har ordineret Fentanyl-ratiopharm til Dem personligt.
Your doctor will decide which strength of Fentanyl-ratiopharm is most suitable for you.
Fentanyl-ratiopharm 75 µg/h TTS og andre berørte navne (se Vedlæg I)
Fentanyl-ratiopharm 75 µg/h TTS and associated names (see Annex I)
KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 depotplaster frigiver 25 mikrogram fentanyl i timen.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 25 micrograms fentanyl per hour.
1 depotplaster frigiver 50 mg fentanyl i timen.
Each patch releases 50 micrograms fentanyl per hour.
Før De begynder at bruge Fentanyl-ratiopharm, skal De fortælle det til Deres læge, hvis De har en af følgende sygdomme.
Before starting to use Fentanyl-ratiopharm you should inform your doctor if you suffer from any of the below disorders, because the risk of side effects is higher and/or your doctor may need to prescribe a lower dose of 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“.
Ændring eller stop i behandlingen bør kun ske i samråd med lægen.
Do not discontinue treatment without consulting your doctor.
Fentanyl-ratiopharm 100 µg/h TTS og andre berørte navne (se Vedlæg I) [Se bilag I - Udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 100 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally]