natgillin/translations-raw huggingface dataset:
Protopy er en hvid til let gullig salve, der indeholder enten 0, 1% eller 0, 03% af det aktive stof tacrolimus. e er
Protopy is a white to slightly yellowish ointment that contains either 0.1% or 0.03% of the active ng ingredient tacrolimus. lo
Hvad anvendes Protopy til? ng
What is Protopy used for?
Protopy anvendes til behandling af moderat til svær atopisk dermatitis (eksem, kløende rødt udslæt på huden – atopisk vil sige, at det er allergisk betinget) hos voksne, der ikke responderer på sædvanlig læ
Protopy is used for the treatment of moderate to severe atopic dermatitis (eczema, an itchy red rash of no
behandling eller ikke kan tåle denne.
the skin- atopic means that is linked to an allergy) in adults who do not respond well or do not tolerate usual treatments.
I den lave styrke (0, 03%) kan Protopy desuden bruges til behandling af denne sygdom hos børn (fra 2- årsalderen), der ikke responderer på sædvanlig e
The lower strength of Protopy (0.03%) may also be used for this condition in children (2 years of age and above) who do not respond well to, or do not tolerate usual treatments. ct
Lægemidlet udleveres kun efter recept. ri
The medicine can only be obtained with a prescription. du
Hvordan anvendes Protopy? te
How is Protopy used?
Protopy bør kun ordineres af læger med erfaring i diagnosticering og behandling af atopisk dermatitis. le
dermatitis. lp
Hvert af de berørte områder behandles med Protopy, indtil huden er helet, hvorefter behandlingen bør id
Each affected area is treated with Protopy until the skin is clear and then treatment a
ophøre.
should be stopped.
Er m
Generally, improvement is seen within one week of starting treatment, and if there is no improvement after 2 weeks, the doctor needs to look at more treatment options. in
der ikke sket nogen forbedring efter to uger, bør lægen overveje andre behandlingsmuligheder. ge
Treatment should be started as ic
Ved indledning af behandlingen gives lægemidlet to gange dagligt i op til tre uger.
twice a day for up to three weeks.
Herefter påføres det kun en gang dagligt, indtil huden er Læ
Afterwards, application should be reduced to once a day until the skin is clear.
Protopy bør ikke anvendes til børn under 2 år.
Protopy should not be used in children under 2 years of age. ed
Hos voksne indledes behandlingen ned Protopy 0, 1% to gange dagligt og fortsætter, til huden er helet.
In adults, treatment should be started with Protopy 0.1% twice a day and treatment should be continued until the skin is clear.
Efterhånden som tilstanden bedres, påføres salven mindre ofte, eller der skiftes til den lave styrke.
strength as their condition improves.
Tacrolimus, det aktive stof i Protopy, er et immunmodulerende stof, dvs. det har indvirkning på immunsystemet (kroppens naturlige forsvar).
Tacrolimus, the active substance in Protopy, is an immunomodulator, this means that it works on the immune system (the body ’ s natural defences).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvordan er Protopy blevet undersøgt?
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Protopy been studied?
800 patienter.
Another study has also looked at the use of Protopy for up to 4 years in about 800 patients.
g resultaterne i score- systemet, men fremkaldte i højere grad en brændende fornemmelse på huden end
ed Protopy was significantly more effective than either of the 2 hydrocortisone preparations at producing improvements in the modified Eczema Area and Severity Index, although it also produced more burning than hydrocortisone.
I den længstvarende undersøgelse kunne Protopy anvendes gentagne gange uden at
In the longer study, Protopy could be used repeatedly without losing its
sa miste sin virkning.
is effectiveness.
Hvilken risiko er der forbundet med Protopy?
or What is the risk associated with Protopy?
et De hyppigste bivirkninger (som ses hos flere end 1 ud af 10 patienter) er en brændende fornemmelse og kløe på påføringsstedet.
th The most common side effects (seen in more than 1 patient in 10) are burning sensation and itching at the application site.
Den fuldstændige liste over de indberettede bivirkninger for Protopy
For the full list of all the side effects reported with Protopy, please see the
er fremgår af indlægssedlen.
au Package Leaflet.
is Protopy bør ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for tacrolimus
Protopy should not be used in people who may be hypersensitive (allergic) to tacrolimus or to any of
or eller andre af indholdsstofferne.
er the other ingredients.
Et meget lille antal patienter har udviklet kræft (hudkræft eller lymfom), mens de fik lægemidlet.
Doctors must be aware that a very small number of patients using the medicine have developed cancer ng (skin cancer, lymphoma).
Der t au er ikke påvist nogen sammenhæng med Protopy.
A link to Protopy has not been shown.
Lægen bør imidlertid have dette for øje og sikre, at lægemidlet anvendes hensigtsmæssigt, og at patienten overvåges under behandlingen. e er
However, doctors must ensure that the medicine is used appropriately. lo
Hvorfor er Protopy blevet godkendt? ng
Why has Protopy been approved? no
Udvalget for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved Protopy er større end risiciene til behandling af moderat til svær atopisk dermatitis hos voksne og børn over to år, læ
The Committee for Medicinal products for Human Use (CHMP) decided that Protopy’ s benefits are greater than its risks for the treatment of moderate to severe atopic dermatitis in adults and children over the age of 2 who are not adequately responsive to or are intolerant of conventional therapies. ct
Udvalget anbefalede udstedelse af markedsføringstilladelse for Protopy. e kk
They recommended that Protopy be given marketing authorisation. du
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske ri
The European Commission granted a marketing authorisation valid throughout the European Union, ro
Union for Protopy til Astellas Pharma GmbH den 28. februar 2002.
for Protopy to Astellas Pharma GmbH on 28 February 2002.
Denne tilladelse blev fornyet den te
The marketing authorisation was renewed on 11-2006.
11- 2006. le
lp
Den Europæiske Offentlige Vurderingsrapport (EPAR) for Protopy kan ses i sin helhed her. id m ge Læ
The full EPAR for Protopy is available here. in ic ed
Dette sammendrag blev sidst opdateret 09- 2007.
This summary was last updated in 09-2007 M
g al s EU- nummer
ed EU-Number
EU/ 1/ 02/ 202/ 001 EU/ 1/ 02/ 202/ 002
Invented name Strength Pharmaceutcal form
Protopy Protopy
Route of administration
0, 03% 0, 03%
Packaging
Salve Salve
Content
1 tube 1 tube
Package size
er EU/ 1/ 02/ 202/ 003
is EU/ 1/ 02/ 202/ 001
0, 1%
0.03%
Tube (laminat)
Tube (laminate)
ris EU/ 1/ 02/ 202/ 004
or EU/ 1/ 02/ 202/ 002
to EU/ 1/ 02/ 202/ 005
th EU/ 1/ 02/ 202/ 003
0, 03%
0.1%
10 g
30 g
au EU/ 1/ 02/ 202/ 006
au EU/ 1/ 02/ 202/ 004 EU/ 1/ 02/ 202/ 005
Protopy
Protopy Protopy
0, 1%
1 tube 1 tube
Salve
0.1%
Tube (laminat)
Tube (laminat)
e er ng læ e kk ri te le id m ge Læ
ng lo o tn uc od pr al in ic ed M
1 BILAG I ng PRODUKTRESUME er e au to ris er et
ed is or th au er ANNEX I ng SUMMARY OF PRODUCT CHARACTERISTICS lo no ct du ro lp a in ic ed M
sal g
1 1.
0, 03% salve
Protopy 0.03% ointment
1 g Protopy 0, 03% salve indeholder 0, 3 mg tacrolimus som tacrolimus monohydrat (0, 03%).
1 g of Protopy 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
s il
ed 3.
t Salve
is Ointment
et er Hvid til svagt gullig salve.
or A white to slightly yellowish ointment.
ris
th au 4.
au Behandling af moderat til svær atopisk dermatitis hos voksne, der ikke responderer tilfredsstillende på eller ikke tåler konventionelle behandlinger såsom topikale kortikosteroider.
er Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or ng are intolerant of conventional therapies such as topical corticosteroids.
Behandling af moderat til e svær atopisk dermatitis hos børn (2 år og ældre), der ikke har responderet tilfredsstillende på konventionelle behandlinger såsom topikale kortikosteroider. er ng
Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to lo conventional therapies such as topical corticosteroids. no
Dosering og indgivelsesmåde
Protopy should be initiated by physicians with experience in the diagnosis and treatment of atopic ct
skal initieres af læger med erfaring i diagnosticering og behandling af atopisk dermatitis. læ
dermatitis. du
Behandling skal være periodisk og ikke vedvarende. e
Treatment should be intermittent and not continuous. ro
Protopy salve kan benyttes kk
Protopy ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. lp
4. 4). i er
Protopy ointment should not be applied under occlusion (see section 4.4). a
Man ser almindeligvis bedring efter 1 uges behandling.
treatment.
Hvis der ikke er tegn på bedring efter 2 ugers behandling, bør anden behandling overvejes.
If no signs of improvement are seen after two weeks of treatment, further treatment options ic
og intermitterende langtidsbehandling.
Protopy can be used for short term and intermittent long term treatment.
Behandling bør genoptages ved de første tegn på tilbagevenden (opblussen) af sygdomssymptomerne. id
At the first signs of recurrence (flares) of the disease symptoms, treatment should be re-initiated. ed
Protopy er ikke anbefalet til brug hos børn under 2 år før yderligere data er tilgængelige. m ge
M
Læ
Afterwards the frequency of application should be reduced to once a day until clearance of the lesion (see section 4.4).
Behandling af voksne (16 år gamle og ældre) Protopy findes i 2 styrker, Protopy 0, 03% og Protopy 0, 1% salve.
Use in adults (16 years of age and above) Protopy is available in two strengths, Protopy 0.03% and Protopy 0.1% ointment.
Behandlingen bør begynde med Protopy 0, 1% to gange om dagen indtil læsionen er helet.
Treatment should be started with Protopy 0.1% twice a day and treatment should be continued until clearance of the lesion.
Hvis symptomerne vender tilbage skal man genoptage behandling med Protopy 0, 1% to gange om dagen.
If symptoms recur, twice daily treatment with Protopy 0.1% should be restarted.
Hvis den kliniske tilstand tillader det, bør man forsøge at reducere hyppigheden af applikationer eller benytte den svagere Protopy 0, 03% salve.
An attempt should be made to reduce the frequency of application or to use the lower strength Protopy 0.03% ointment if the clinical condition allows.
g al Overfølsomhed over for macrolider generelt, over for tacrolimus eller over for et eller flere af hjælpestofferne.
Hypersensitivity to macrolides in general, to tacrolimus or to any of the excipients.
Særlige advarsler og forsigtighedsregler vedrørende brugen
ed 4.4 Special warnings and precautions for use
t Protopy må ikke anvendes til patienter med medfødt eller erhvervet immundefekt eller til patienter i
is Protopy should not be used in patients with congenital or acquired immunodeficiencies or in patients
et behandling som forårsager immunsuppression.
or on therapy that cause immunosuppression.
er Virkningen af behandling med Protopy salve på det ikke færdigudviklede immunsystem hos børn,
th The effect of treatment with Protopy ointment on the developing immune system of children, especially the young, has not yet been established and this should be taken into account when
4. 1).
au prescribing to this age group (see section 4.1).
to Så længe hudområder behandles med Protopy salve skal hudens eksponering for sollys minimeres og
Exposure of the skin to sunlight should be minimised and the use of ultraviolet (UV) light from a
5. 3).
er solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use of Protopy ointment (see section 5.3).
Lægen bør anvise patienterne egnede solbeskyttelsesmetoder, som f. eks. minimering af den tid, der tilbringes i solen, brug af solbeskyttende cremer samt tildækning e af huden med passende beklædning.
Physicians should advise patients on appropriate sun ng protection methods, such as minimisation of the time in the sun, use of a sunscreen product and covering of the skin with appropriate clothing.
Protopy salve må ikke anvendes på læsioner som bedømmes for at være potentielt maligne eller præmaligne. er ng
Protopy ointment should not be applied to lesions that lo are considered to be potentially malignant or pre-malignant. no
Der er ingen erfaring med samtidig behandling med systemiske steroider eller immunosuppressive læ
There is no experience with concomitant use of systemic steroids or immunosuppressive agents. ct
Protopy salve er ikke blevet afprøvet for effekt og tolerabilitet ved behandling af klinisk inficeret e
Protopy ointment has not been evaluated for its efficacy and safety in the treatment of clinically du
atopisk dermatitis.
infected atopic dermatitis.
Før man starter behandling med Protopy salve skal alle områder med klinisk kk
Before commencing treatment with Protopy ointment, clinical infections at treatment sites should be cleared.
Patienter med atopisk dermatitis er prædisponerede for superficielle hud infektioner.
Patients with atopic dermatitis are predisposed to superficial skin ro
(herpes simplex dermatitis [eczema herpeticum], herpes simplex [forkølelsessår], Kaposi' s er
Treatment with Protopy may be associated with an increased risk of herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi’ s varicelliform lp
varicelliforme eruption).
eruption).
Man bør tage disse infektioner i betragtning når man vurderer risici og fordele ved Protopy.
In the presence of these infections, the balance of risks and benefits associated with Protopy use should be evaluated. a
5. 1). id
The potential for local immunosuppression (possibly resulting in infections or cutaneous malignancies) in the long term (i. e. over a period of years) is unknown (see section 5.1). in ic
Hos transplantationspatienter er langvarig systemisk og intens immunosuppression efter systemisk m
In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of ed
administration af calcinurinhæmmere associeret med en øget risiko for udvikling af lymfomer og ge
In patients using tacrolimus ointment, cases of malignancies, including cutaneous and M
Der er rapporteret tilfælde af maligniteter, inkl. hud og andre typer lymfom hos patienter, som bruger tacrolimus salve (se pkt 4. 8).
other types of lymphoma, and skin cancers have been reported (see section 4.8).
Læ
Patients with atopic dermatitis treated with Protopy have not been found to have significant systemic tacrolimus levels.
Transplanterede patienter, der får immunosuppressiv behandling (f. eks. systemisk tacrolimus) har en øget risiko for at udvikle lymfomer, hvorfor patienter, der behandles med Protopy og udvikler lymphadenopati bør følges nøje for at sikre, at lymphadenopatien helbredes.
Transplant patients receiving immunosuppressive regimens (e. g. systemic tacrolimus) are at increased risk for developing lymphoma; therefore patients who receive Protopy and who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
3 kan finde en klar årsag til lymphadenopatien, eller i tilfælde af akut infektiøs mononucleose bør behandlingen med Protopy seponeres.
3 the absence of a clear aetiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Protopy should be considered.
Som ved alle andre hudmidler, bør patienten vaske hænder efter påsmøring, med mindre man også
As with any topical medicinal product, patients should wash their hands after application if the hands are not intended for treatment.
al Tacrolimus er ekstensivt metaboliseret i leveren, og selv om blodkoncentrationerne er lave i
Tacrolimus is extensively metabolised in the liver and although blood concentrations are low
5. 2).
ed following topical therapy, the ointment should be used with caution in patients with hepatic failure (see section 5.2).
t Det kan ikke anbefales at benytte Protopy salve til patienter med genetisk epidermale barrieredefekter
is The use of Protopy ointment in patients with genetic epidermal barrier defects such as Netherton’ s
et som Netherton' s syndrome på grund af potentialet for permanent øget systemisk absorption af
or syndrome is not recommended due to the potential for permanently increased systemic absorption of tacrolimus.
er tacrolimus.
th erythroderma.
4. 2).
au Care should be exercised if applying Protopy to patients with extensive skin involvement over an extended period of time, especially in children (see section 4.2).
Interaktion med andre lægemidler og andre former for interaktion
er 4.5 Interaction with other medicinal products and other forms of interaction
Der er ikke udført formelle lokale interaktionsstudier med Protopy salve. e Da tacrolimus ikke metaboliseres i huden, er der intet potentiale for perkutane interaktioner, der ville er kunne påvirke metabolismen af tacrolimus. ng
ng Formal topical drug interaction studies with tacrolimus ointment have not been conducted. lo Tacrolimus is not metabolised in human skin, indicating that there is no potential for percutaneous interactions that could affect the metabolism of tacrolimus. no
Den systemiske eksponering fra lokal anvendelse af tacrolimus er lav (< 1, 0 ng/ ml) og påvirkes næppe ved læ
Systemic exposure from topical application of tacrolimus ointment is low (< 1.0 ng/ ml) and is unlikely ct
samtidig brug af kendte inhibitorer of CYP3A4.
to be affected by concomitant use of substances known to be inhibitors of CYP3A4.
Da muligheden for interaktioner imidlertid ikke helt kan udelukkes, bør samtidig administrering af kendte CYP3A4 inhibitorer (f. eks. erythromycin, itaconazol, ketoconazol og diltiazem) til patienter med udbredte og/ eller erythrodermiske lidelser ske e
However, the possibility of interactions cannot be ruled out and the concomitant systemic administration of known du
med forsigtighed. kk
CYP3A4 inhibitors (e. g. erythromycin, itraconazole, ketoconazole and diltiazem) in patients with widespread and/ or erythrodermic disease should be done with caution. ro
På grund i
A potential interaction between vaccination and application of Protopy ointment has not been lp
af risikoen for manglende effekt at vaccinationer, bør man vaccinere før start på behandling eller i er
In case of live attenuated vaccination, this a
Ved brug af levende, afsvækkede vacciner bør perioden øges til 28 dage eller man må overveje at bruge anden vaccine. t le
period should be extended to 28 days or the use of alternative vaccines should be considered. in ic
Graviditet og amning
4.6 Pregnancy and lactation ed
Dyreforsøg m
There are no adequate data from the use of tacrolimus ointment in pregnant women.
Den potentielle risiko for ge
The potential M
mennesker er ukendt.
risk for humans is unknown.
Læ
Protopy ointment should not be used during pregnancy unless clearly necessary.
g I kliniske studier oplever omkring 50% af patienter en eller anden form for hudirritation på
In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application.
s almindeligt rapporterede bivirkninger.
Erythema was a common skin irritation adverse reaction.
il applikationsstedet er ligeledes almindeligt forekommende.
Sensation of warmth, pain, paraesthesia and rash at the site of application were also commonly observed.
Alkohol intolerance (flushing eller
Alcohol intolerance (facial flushing or skin irritation after
t hudirritation efter indtagelse af en alkoholisk drik) er også almindelig.
ed consumption of an alcoholic beverage) was common.
et er Bivirkninger, der formodes at være relaterede til behandlingen, er angivet nedenfor efter systemorganklasser.
is Adverse reactions with suspected relationship to treatment are listed below by system organ class.
Hyppigheden er defineret som meget almindelig (> 1/ 10), almindelig (> 1/ 100,
or Frequencies are defined as very common (> 1/ 10), common (> 1/ 100 ,< 1/10) and uncommon (> 1/1 ,000, < 1/100).
Indenfor hver gruppe af bivirkninger med samme frekvens skal bivirkningerne opstilles efter hvor alvorlige bivirkningerne er.
Within each frequency grouping, undesirable effects are presented in order of
De mest alvorlige skal anføres først.
th decreasing seriousness.
to au Almene lidelser og reaktioner på indgivelsesstedet Meget almindelig:
au General disorders and administration site conditions Very common:
Varme på applikationsstedet, erythem på applikationsstedet, smerte på e applikationsstedet, irritation på applikationsstedet, paræstesi på applikationsstedet, udslæt på applikationsstedet er ng
Application site burning, application site pruritus Application site warmth, application site erythema, application site pain,
Infektiøse og parasitære sygdomme
er application site irritation, application site paraesthesia, application site rash
Herpes virus infektioner (herpes simplex dermatitis [eczema herpeticum], herpes simplex [forkølelsessår], Kaposi' s varicelliforme eruption) læ
Infections and infestations Common: ng Herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes lo simplex [cold sores], Kaposi’ s varicelliform eruption) no
pruritus e
Folliculitis, pruritus Acne ct
Sygdomme i nervesystemet i
Nervous system disorders du
Paræstesi og dysæstesi (hyperæsthesi brændende følelse)
Paraesthesias and dysaesthesias (hyperaesthesia, burning sensation) ro
Almindelig: t le
Metabolism and nutrition disorders Common:
Alkoholintolerance (flushing eller hudirritation efter indtagelse af alkohol)
Alcohol intolerance (facial flushing or skin irritation after consumption of an lp
Følgende bivirkninger er blevet rapporteret efter markedsføringen: id
The following adverse reactions have been reported during post-marketing experience: a
Rosacea m
Rosacea in ic
4. 4).
Post-marketing: cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers, have been reported in patients using tacrolimus ointment (see section 4.4). ed
Læ
4.9 Overdose M
5
5 5.
Følgende er observeret,
Mechanism of action and pharmacodynamic effects The mechanism of action of tacrolimus in atopic dermatitis is not fully understood.
g men den kliniske betydning af disse observationer i atopisk dermatitis er ikke kendt.
While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known.
al Via binding til et specifikt cytoplasmisk immunophilin (FKBP12) hæmmer tacrolimus calciumafhængig signal transduktion i T- celler og hindrer på denne måde transkription og syntese af
Via its binding to a specific cytoplasmic immunophilin (FKBP12), tacrolimus inhibits calcium-
s IL- 2, IL- 3, IL- 4, IL- 5 og andre cytokiner som GM- CSF, TNF- α og IFN- γ.
ed dependent signal transduction pathways in T cells, thereby preventing the transcription and synthesis of IL-2, IL-3, IL-4, IL-5 and other cytokines such as GM-CSF, TNF-α and IFN-γ.
il In vitro reducerer tacrolimus den stimulerende effekt på T- celler i Langerhans celler isoleret fra
In vitro, in Langerhans cells isolated from normal human skin, tacrolimus reduced the stimulatory
t normal human hud.
is activity towards T cells.
Tacrolimus er også vist at hæmme frigørelse af inflammations mediatorer fra hudmastceller og fra basofile og eosinofile leukocyter.
Tacrolimus has also been shown to inhibit the release of inflammatory
et I dyr undertrykker tacrolimus salve inflammatoriske reaktioner i eksperimentelle og spontane
In animals, tacrolimus ointment suppressed inflammatory reactions in experimental and spontaneous
er dermatitismodeller, der ligner den humane atopiske dermatitis.
th dermatitis models that resemble human atopic dermatitis.