natgillin/translations-raw huggingface dataset:
ris Systemisk tilgængeligt tacrolimus metaboliseres via hepatisk Cytochrom P450 3A4 (CYP3A4).
au Systemically available tacrolimus is metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4).
Den systemiske eksponering fra lokal anvendelse af tacrolimus er lav (< 1, 0 ng/ ml) og påvirkes næppe ved
Systemic exposure from topical application of tacrolimus ointment is low (< 1.0 ng/ ml) and is unlikely to be affected by concomitant use of substances known to be inhibitors of CYP3A4.
to samtidig brug af kendte inhibitorer of CYP3A4.
However, the
au 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 med forsigtighed. e Man har ikke undersøgt den mulige interaktion mellem vaccination og brug af Protopy salve.
er possibility of interactions cannot be ruled out and the concomitant systemic administration of known CYP3A4 inhibitors (e. g. erythromycin, itraconazole, ketoconazole and diltiazem) in patients with ng widespread and/ or erythrodermic disease should be done with caution. lo A potential interaction between vaccination and application of Protopy ointment has not been investigated.
På grund er af risikoen for manglende effekt at vaccinationer, bør man vaccinere før start på behandling eller i ng
Because of the potential risk of vaccination failure, vaccination should be administered no
behandlingsfri intervaller med en periode på 14 dage mellem den sidste påsmøring af Protopy salve og vaccination.
prior to commencement of treatment, or during a treatment-free interval with a period of 14 days between the last application of Protopy and the vaccination.
Ved brug af levende, afsvækkede vacciner bør perioden øges til 28 dage eller man må overveje at bruge anden vaccine. læ
In case of live attenuated vaccination, this period should be extended to 28 days or the use of alternative vaccines should be considered. ct
Graviditet og amning
4.6 Pregnancy and lactation du
Dyreforsøg kk
Studies in animals ro
5. 3).
have shown reproductive toxicity following systemic administration (see section 5.3).
Den potentielle risiko for mennesker er ukendt. i er
The potential risk for humans is unknown. lp
Protopy salve bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
Protopy ointment should not be used during pregnancy unless clearly necessary. a
Efter systemisk administrering udskilles tacrolimus i modermælken.
Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk. in
Selv om den systemiske t le
Although clinical data have shown that systemic exposure from application of tacrolimus ointment is ic
eksponering er lav ved brug af Protopy salve bør kvinder i behandling med Protopy salve ikke amme. id
low, breast-feeding during treatment with Protopy ointment is not recommended. ed
Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines M
Da ge
No studies on the effects on the ability to drive and use machines have been performed.
Læ
Protopy ointment is administered topically and is unlikely to have an effect on the ability to drive or use machines.
Varmefølelse, smerte, paræstesie og udslæt på applikationsstedet er ligeledes almindeligt forekommende.
Sensation of warmth, pain, paraesthesia and rash at the site of
g Almene lidelser og reaktioner på indgivelsesstedet
General disorders and administration site conditions Very common:
Brænden på applikationsstedet, kløe på applikationsstedet
Application site burning, application site pruritus
Almindelig:
ed Common:
s applikationsstedet, irritation på applikationsstedet, paræstesi på applikationsstedet,
Application site warmth, application site erythema, application site pain, application site irritation, application site paraesthesia, application site rash
il udslæt på applikationsstedet
is Infections and infestations
Almindelig:
or Common:
Herpes virus infektioner (herpes simplex dermatitis [eczema herpeticum], herpes
Herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi’ s varicelliform eruption)
ris Sygdomme i hud og subkutane væv
th Skin and subcutaneous tissue disorders
Almindelig:
au Common:
Almindelig:
er Nervous system disorders Common:
Almindelig:
Metabolism and nutrition disorders ng lo Common:
Alkoholintolerance (flushing eller hudirritation efter indtagelse af alkohol) er ng
Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) no
Rosacea læ
Rosacea ct
4. 4). e
Post-marketing: cases of malignancies, including cutaneous and other types of lymphoma, and skin du
4. 9
cancers, have been reported in patients using tacrolimus ointment (see section 4.4). ro
Overdosering
4.9 Overdose lp
Overdosering som følge af lokal applikation er usandsynlig. i
Overdosage following topical administration is unlikely.
Disse kan omfatte er
These may include monitoring of vital signs and observation of clinical status.
På grund af salvegrundlagets sammensætning kan provokation af opkastning eller maveskylning ikke anbefales. t le
vomiting or gastric lavage is not recommended. in ic
FARMAKOLOGISKE EGENSKABER
PHARMACOLOGICAL PROPERTIES ed
Farmakodynamiske egenskaber
5.1 Pharmacodynamic properties M
al Effekt og tolerabilitet er blevet undersøgt i mere end 13. 500 patienter behandlet med tacrolimus salve i fase I til fase III kliniske afprøvninger.
ed Results from clinical studies in patients The efficacy and safety of Protopy was assessed in more than 13,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
s I en seks- måneders multicenter, dobbelt- blind, randomiseret afprøvning blev 0, 1% tacrolimus salve
is In a six-month multicentre double-blind randomised trial, 0.1% tacrolimus ointment was administered
il administreret 2 gange om dagen til voksne med moderat til svær atopisk dermatitis, og blev
or twice-a-day to adults with moderate to severe atopic dermatitis and compared to a topical corticosteroid based regimen (0.1% hydrocortisone butyrate on trunk and extremities, 1%
t sammenlignet med lokal kortikosteroid behandling (0, 1% hydrokortison butyrat på kroppen og ekstremiteter og 1% hydrokortison acetat på ansigt og hals).
th hydrocortisone acetate on face and neck).
et ved måned 3, defineret som delen af patientgruppen med mindst 60% forbedring i mEASI (modified
The primary endpoint was the response rate at month 3 defined as the proportion of patients with at least 60% improvement in the mEASI (modified Eczema
er Eczema Area and Severity Index) fra baseline til måned 3.
au Area and Severity Index) between baseline and month 3.
Respons raten i 0, 1% tacrolimus gruppen (71, 6%) var signifikant højere end den i gruppen med lokal kortikosteroid behandling (50, 8%,
The response rate in the 0.1% tacrolimus group (71.6%) was significantly higher than that in the topical corticosteroid based treatment group (50.8%; p < 0.001; Table 1).
Tabel 1
er Table 1
Tacrolimus 0, 1%
regimen§
kortikosteroidbehandling § (N=485)
Topical corticosteroid lo (N=485)
Respons rate på ≥ 60% bedring
Response rate of ≥ 60%
50,
50.8% no
i mEASI (Primær parameter) §§ er
improvement in mEASI (Primary Endpoint)§§
Forbedring ≥ 90% i lægens samlede vurdering
Improvement ≥ 90% in Physician’ s 28.5% ct
ng
Global Evaluation § Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% du
§ Lokal kortikosteroidbehandling = 0, 1% hydrokortison butyrat på krop og ekstremiteter, 1% hydrokortison acetat på ansigt og hals. §§ højere værdi = større bedring læ
hydrocortisone acetate on face and neck §§ higher values = greater improvement ro
Brændende fornemmelse i huden, e
Skin lp
herpes simplex, alkoholintolerance (facial flushing eller øget hudfølsomhed efter alkoholindtagelse), prikken i huden, hyperæstesi, acne og fungal dermatitis forekom dog hyppigere i tacrolimus gruppen. kk
burning, herpes simplex, alcohol intolerance (facial flushing or skin sensitivity after alcohol intake), skin tingling, hyperaesthesia, acne and fungal dermatitis occurred more often in the tacrolimus a
Der var ingen klinisk relevante ændringer i laboratorieværdier eller i puls og blodtryk i nogen af grupperne i studiets forløb. i er
either treatment group throughout the study. ic
I den anden kliniske afprøvning blev børn i alderen 2 år til 15 år med moderat til svær atopisk dermatitis behandlet 2 gange om dagen i 3 uger med 0, 03% tacrolimus salve 0, 1% tacrolimus salve t
In the second trial, children aged from 2 to 15 years with moderate to severe atopic dermatitis received twice daily treatment for three weeks of 0.03% tacrolimus ointment, 0.1% tacrolimus ointment or 1% ed
eller 1% hydrokortison acetat salve.
hydrocortisone acetate ointment.
Den primære parameter var area- under- the curve (AUC) af le
The primary endpoint was the area-under-the-curve (AUC) of the mEASI as a percentage of baseline averaged over the treatment period.
Resultaterne af denne multicenter, dobbelt- blinde, randomiserede afprøvning viste at tacrolimus salve, 0, 03% og 0, 1% har id
The results of this multicentre, M
signifikant bedre effekt (p < 0, 001 for begge) end 1% hydrokortison acetat salve (Tabel 2). m
double-blind, randomised trial showed that tacrolimus ointment, 0.03% and 0.1%, is significantly more effective (p < 0.001 for both) than 1% hydrocortisone acetate ointment (Table 2).
Hydrokortison acetat 1%
Hydrocortisone acetate 1% (N=185)
(N=185)
Median mEASI
Median mEASI som procent af baseline mean AUC (Primær parameter) §
as Percentage of
Bedring ≥ 90% i lægens samlede 15, 7% vurdering § mindre værdier = større positiv effekt
Baseline mean AUC (Primary Endpoint)§ Improvement ≥ 90% in Physician’ s Global Evaluation § lower values = greater improvement
15 Incidensen af brændende følelse i huden var højere i gruppen der blev behandlet med tacrolimus end i hydrokortison gruppen.
ed The incidence of local skin burning was higher in the tacrolimus treatment groups than in the hydrocortisone group.
Der var ingen klinisk relevante ændringer i laboratorieværdier eller i puls og blodtryk i nogen af behandlingsgrupperne.
is in either treatment group throughout the clinical trial.
Formålet med det tredje multicenter, dobbelt- blind, randomiserede studie var at undersøge effekt og tolerabilitet af 0, 03% tacrolimus salve, når denne blev appliceret 1- 2 gange om dagen sammenlignet med administrering af 1% hydrokortison acetat 2 gange om dagen til børn med moderat til svær
th and safety of 0.03% tacrolimus ointment applied once or twice a day relative to twice daily administration of 1% hydrocortisone acetate ointment in children with moderate to severe atopic
g atopisk dermatitis.
au dermatitis.
1%
er
2 gange om dagen (N = 207)
Hydrocortisone acetate 1% Twice daily (N=207)
et
ng lo Median mEASI Percentage Decrease (Primary Endpoint)§
ris
78.7%
Bedring ≥ 90% i lægens 13, 6% samlede vurdering
Improvement ≥ 90% in Physician’ s Global Evaluation
to § højere værdi = større bedring
§ higher values = greater improvement ct
au Den primære parameter var defineret som den procentvise formindskelse af mEASI fra baseline og indtil afslutning af behandlingen.
The primary endpoint was defined as the percentage decrease in mEASI from the baseline to end of du
En statistisk signifikant øget bedring blev vist for administration en gang om dagen og for administrering af 0, 03% tacrolimus salve to gange om dagen i sammenligning e med administrering af 1% hydrokortison acetat salve (p < 0, 001 for begge).
A statistically significant better improvement was shown for once daily and twice daily 0.03% tacrolimus ointment compared to twice daily hydrocortisone acetate ointment (p < 0.001 for ro
0, 03% tacrolimus salve er appliceret 2 gange om dagen var mere effektivt end applikation en gang om dagen Tabel 3).
Twice daily treatment with 0.03% tacrolimus ointment was more effective than once daily administration (Table 3).
Incidensen af brændende følelse i huden var højere i tacrolimus behandlingsgruppen end i ng
The incidence of local skin burning was higher in the tacrolimus treatment lp
hydrokortison gruppen.
groups than in the hydrocortisone group.
Der var ingen klinisk relevante ændringer i laboratorieværdier eller i puls og blodtryk i nogen af grupperne i løbet af studiets. læ
There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the study. a in
I det fjerde studie blev omkring 800 patienter (≥ 2 år gamle) behandlet intermitterende eller kontinuerligt i op til 4 år med 0, 1% tacrolimus salve i et åbent langtidsstudie af tolerabilitet med 300 e
In the fourth trial, approximately 800 patients (aged ≥ 2 years) received 0.1% tacrolimus ointment intermittently or continuously in an open-label, long-term safety study for up to four years, with 300 ic
patienter der blev behandlet i mindst 3 år og 79 patienter der blev behandlet i mindst 42 måneder.
patients receiving treatment for at least three years and 79 patients receiving treatment for a minimum ed
bedring af den atopiske dermatitis ved alle de følgende målinger.
Based on changes from baseline in EASI score and body surface area affected, patients regardless of age had improvement in their atopic dermatitis at all subsequent time points.
Den samlede incidens af bivirkninger mindskedes i studiets forløb for alle i
The overall M
De tre mest almindelige bivirkninger, der blev rapporteret, var er
incidence of adverse events tended to decrease as the study progressed for all patients independent of age.
Man så i dette langtidsstudie ingen bivirkninger, der ikke var t
The three most common adverse events reported were flu-like symptoms (cold, common cold, influenza, upper respiratory infection, etc.), pruritus and skin burning.
rapporteret ved kortere behandlingstid og/ eller tidligere studier. le
No adverse events previously unreported in shorter duration and/ or previous studies were observed in this long-term study.
Kliniske data har vist, at koncentrationen af tacrolimus i den systemiske cirkulation er lav efter applikation på huden, og i de tilfælde koncentrationen har været målelig, kun målelig i kortere ge
Clinical data have shown that tacrolimus concentrations in systemic circulation after topical administration are low and, when measurable, transient.
Absorption Data fra sunde forsøgspersoner indicerer, at der kun er ringe eller ingen systemisk eksponering af tacrolimus efter en enkelt eller gentagen applikation af tacrolimus salve.
16 Absorption Data from healthy human subjects indicate that there is little or no systemic exposure to tacrolimus following single or repeated topical application of tacrolimus ointment.
16 overflade, er den systemiske eskponering (dvs AUC) af tacrolimus fra Protopy cirka 30- gange mindre end hvad man finder ved orale immunosuppressive doser i nyre - og levertransplanterede patienter.
AUC) of tacrolimus from Protopy is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
Fordeling Da den systemiske eksponering er lav ved behandling med tacrolimus salve, er den kraftige
is or Distribution As systemic exposure is low with tacrolimus ointment, the high binding of tacrolimus (> 98.8%) to
g plasmabinding af tacrolimus (> 98, 8%) næppe klinisk relevant.
th plasma proteins is considered not to be clinically relevant.
al Efter lokal applikation af tacrolimus salve, bliver tacrolimus selektivt optaget i huden med minimal diffusion til den systemiske cirkulation.
au with minimal diffusion into the systemic circulation.
s il Metabolisme
Metabolism
t Der er ikke tegn på, at tacrolimus metaboliseres af human hud.
er Metabolism of tacrolimus by human skin was not detectable.
Den
Elimination ng lo When administered intravenously, tacrolimus has been shown to have a low clearance rate.
ris gennemsnitlige totale clearance fra kroppen er omkring 2, 25 l/ time.
The average total body clearance is approximately 2.25 l/ h.
Den hepatiske clearance af systemisk tilgængeligt tacrolimus kan vær nedsat hos patienter med svær nedsættelse af leverfunktionen, eller ved samtidig behandling med lægemidler, der er potente inhibitorer af CYP3A4.
The hepatic clearance of systemically available no
to Efter gentagen lokal applikation af salven, beregnede man halveringstiden til 75 timer for voksne og
tacrolimus could be reduced in subjects with severe hepatic impairment, or in subjects who are co- treated with drugs that are potent inhibitors of CYP3A4.
au 65 timer for børn.
estimated to be 75 hours for adults and 65 hours for children. du
Prækliniske sikkerhedsdata
5.3 Preclinical safety data ro
Kronisk toksicitet og lokal tolerabilitet er Gentagen lokal administrering af enten tacrolimus salve eller af salvegrundlag til rotter, kaniner og ng
Repeated dose toxicity and local tolerance Repeated topical administration of tacrolimus ointment or the ointment vehicle to rats, rabbits and lp
minigrise medførte lettere dermale ændringer så som erythem, ødem og papler.
micropigs was associated with slight dermal changes such as erythema, oedema and papules.
Forandringerne skyldtes kraftig læ
The changes were caused by high systemic exposure of a
systemisk eksponering i gnavere på grund af udtalt transdermal absorption af tacrolimus.
rodents resulting from high transdermal absorption of tacrolimus.
En noget mindre øgning af kropsvægten i hundyr var eneste tegn på systemisk eksponering i minigrise ved brug af salve med højt indhold af tacrolimus (3%). e
Slightly lower body weight gain in in
Kaniner er specielt følsomme for tacrolimus administreret intravenøst, idet man ser reversibel kk
females was the only systemic change observed in micropigs at high ointment concentrations (3%). ic
kardiotoksicitet. i
Rabbits were shown to be especially sensitive to intravenous administration of tacrolimus, reversible cardiotoxic effects being observed. ed
Mutagenicitet er
Mutagenicity M
Med relevante in vitro og in vitro tests har man ikke kunnet påvise tegn på mutagent potentiale af tacrolimus. t le
In vitro and in vivo tests did not indicate a genotoxic potential of tacrolimus.
Carcinogenicitet Systemiske carcinogenicitets undersøgelser i mus (18 måneder) og rotter (24 måneder) viste ingen id
Carcinogenicity Systemic carcinogenicity studies in mice (18 months) and rats (24 months) revealed no carcinogenic potential of tacrolimus.
I denne undersøgelse fandt man en øget forekomst af lymfomer på grund af ge
In a 24-month dermal carcinogenicity study performed in mice with 0.1% ointment, no skin tumours were observed.
den høje systemiske eksponering.
In the same study an increased incidence of lymphoma was detected in association with high systemic exposure.
Det er uklart om effekten skyldes en systemisk immunosuppression eller en lokal effekt.
Animals treated with tacrolimus ointment showed a statistically significant reduction in time to skin tumour (squamous cell carcinoma) development and an increase in the
17
17 number of tumours.
6.
Reproduction toxicity Embryo/ foetal toxicity was observed in rats and rabbits, but only at doses that caused significant toxicity in maternal animals.
FARMACEUTISKE OPLYSNINGER
Reduced sperm function was noted in male rats at high subcutaneous doses of tacrolimus.
Fortegnelse over hjælpestoffer
ed 6.1 List of excipients
Hvid vaselin Paraffinolie
is White soft paraffin
g Propylenkarbonat
or Liquid paraffin Propylene carbonate
al Hvidt voks Paraffin
th White beeswax Hard paraffin
Uforligeligheder
au 6.2 Incompatibilities
t Ikke relevant.
er Not applicable.
et er
6.3
6. 3
Shelf life
Opbevaringstid
lo
ris 3 år
ng
6. 4
3 years no
to au Må ikke opbevares over 25°C.
Do not store above 25°C. ct
Emballage (art og indhold)
6.5 Nature and contents of container du
Laminat tube med en inderbeklædning af low- density- polyætylen lukket med et hvidt polypropylen er skruelåg. ng
Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene ro
Ikke alle pakningsstørrelser er nødvendigvis markedsført. læ
Not all pack sizes may be marketed. a
Særlige forholdsregler ved bortskaffelse
6.6 Special precautions for disposal in
Ingen særlige forholdsregler. e
No special requirements. ic
Ikke anvendt lægemiddel samt affald heraf bør bortskaffes i overensstemmelse med lokale krav.
Any unused product or waste material should be disposed of in accordance with local requirements. ed
AF MARKEDSFØRINGSTILLADELSEN er
MARKETING AUTHORISATION HOLDER M
61 t le
61 D-81673 München Germany
EU/ 1/ 02/ 202/ 003 EU/ 1/ 02/ 202/ 004 Læ
EU/ 1/ 02/ 202/ 003 EU/ 1/ 02/ 202/ 004 18 EU/ 1/ 02/ 202/ 006
{DD/ MM / ÅÅÅÅ}
ed {DD/ MM/ YYYY}
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu.
is Detailed information on this medicinal product is available on the website of the European Medicines
g
or Agency (EMEA) http: / /www. emea. europa. eu
ris
th au er ng lo no ct du ro
m
a
id
lp
le
ic ed M
19 g als t il et er ris to au BILAG II
19 ed is or th au er ANNEX II
A. e INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE er ng
A. ng MANUFACTURING AUTHORISATION HOLDER lo RESPONSIBLE FOR BATCH RELEASE no
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN læ e kk i
CONDITIONS OF THE MARKETING AUTHORISATION ct du ro
er
lp
id m ge Læ
in ic ed M
20
20 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
ed B CONDITIONS OF THE MARKETING AUTHORISATION
BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
t
is THE MARKETING AUTHORISATION HOLDER
et er Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I:
or Medicinal product subject to restricted medical prescription (See Annex I:
Produktresumé; pkt.
Summary of Product
ris
th Characteristics, section 4.2).
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET
au • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
to Ikke relevant.
er Not applicable.
au e er ng læ e
ng lo no ct du ro ed M
le
ic
21 Læ ge m id le
21 ed is or th au er ANNEX III ng LABELLING AND PACKAGE LEAFLET lo no ct du ro lp a in ic ed M
22 ng BILAG III er e ETIKETTERING OG INDLÆGSSEDDEL au to ris er et
22 M ed ic in alp ro du ct
23 ng A.
23 no
t
lo
il
A.
sal g
ng er au th or is ed PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PROTOPY 0, 03% SALVE (10 g, 30 g, 60 g YDRE EMBALLAGE)
PROTOPY 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
al Tacrolimus monohydrat
Protopy 0.03% Ointment Tacrolimus monohydrate
s il
ed 2.
t et 1 g salve indeholder:
is 1 g ointment contains:
3.
or th 3.
ris hvid vaselin, paraffinolie, propylenkarbonat, hvidt voks, paraffin.
au white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin.
to au
er 4.
Salve 10 g 30 g
Ointment 10 g 30 g
e er ng
ng
60 g læ
60 g
ANVENDELSESMÅDE OG INDGIVELSESVEJ e
METHOD AND ROUTE OF ADMINISTRATION du
Kutan anvendelse kk
Cutaneous use ro
Læs indlægssedlen inden brug. i er
Read the package leaflet before use. lp
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN t le
OF THE REACH AND SIGHT OF CHILDREN in
Opbevares utilgængeligt for børn. id m
Keep out of the reach and sight of children. ic ed
EVENTUELLE ANDRE SÆRLIGE ADVARSLER
OTHER SPECIAL WARNING(S), IF NECESSARY M
opbevares over 25°C.
Do not store above 25°C.
24
24 10.
Astellas Pharma GmbH
Astellas Pharma GmbH Neumarkter Str.
al D- 81673 München Tyskland
ed Germany
s t il
is 12.
et EU/ 1/ 02/ 202/ 005 10 g
or EU/ 1/ 02/ 202/ 005 10 g
er EU/ 1/ 02/ 202/ 001 30 g EU/ 1/ 02/ 202/ 002 60 g
th EU/ 1/ 02/ 202/ 001 30 g EU/ 1/ 02/ 202/ 002 60 g
ris to
au 13.
au Lot:
er Lot:
{nummer}
{number} ng lo 14.
14. e GENEREL KLASSIFIKATION FOR UDLEVERING er Receptpligtigt lægemiddel. ng læ
Medicinal product subject to medical prescription. ct
INSTRUKTIONER VEDRØRENDE ANVENDELSEN e
INSTRUCTIONS ON USE du
INFORMATION I BRAILLE- SKRIFT kk
INFORMATION IN BRAILLE ro lp
Protopy 0. 03% i ge Læ
Protopy 0.03% a in ic ed M
PROTOPY 0, 03% SALVE (10 g TUBE)
PROTOPY 0.03% OINTMENT (10 g TUBE)