natgillin/translations-raw huggingface dataset:
5. 2 ” Farmakokinetiske egenskaber ”), vurderes den potentielle risiko for mennesker dog som værende begrænset.
However, based on the minimal extent of pimecrolimus absorption after topical application of < Invented Name >, (see Section 5.2 “Pharmacokinetic properties”), the potential risk for humans is considered limited.
Der bør udvises forsigtighed når {(Sær) navn} bruges af ammende kvinder.
Caution should be exercised when < Invented Name > is administered to breastfeeding women.
Ammende mødre kan anvende {(Sær) navn}, men bør ikke applicere {(Sær) navn} på brystet, for at undgå, at barnet utilsigtet indtager cremen.
Breastfeeding mothers may use < Invented Name > but should not apply < Invented Name > to the breast in order to avoid unintentional oral uptake by the newborn.
{(Sær) navn} har ingen kendt indflydelse på evnen til at føre bil eller betjene maskiner.
< Invented Name > has no known effect on the ability to drive and use machines.
19% af patienterne behandlet med {(Sær) navn} og 16% af patienterne i kontrolgrupperne.
The most common adverse events were application site reactions which were reported by approximately 19% of the patients treated with < Invented Name > and 16% of patients in the control groups.
Disse reaktioner opstod som regel tidligt i behandlingen, var af mild/ moderat sværhedsgrad og kortvarige.
These reactions generally occurred early in treatment, were mild/moderate and were of short duration.
Hyppighedsberegning: meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10); usædvanlig (≥1/ 1000, < 1/ 100); sjælden (≥1/ 10. 000, < 1/ 1000); meget sjælden (< 1/ 10. 000, herunder enkeltstående indberetninger).
Frequency estimates: very common (≥1/10); common (≥1/100, < 1/10); uncommon (≥1/1,000, < 1/100); rare (≥1/10,000, < 1/1,000); very rare (< 1/10,000, including isolated reports).
- Meget almindelig: brænden ved applikationsstedet.
- very common: application site burning.
- Almindelig: reaktioner ved applikationsstedet (irritation, pruritus og erythem), hudinfektioner
- common: application site reactions (irritation, pruritus and erythema), skin infections
(folliculitis).
(folliculitis).
- Usædvanlig: furunkel, impetigo, herpes simplex, herpes zoster, herpes simplex dermatitis
- uncommon: furuncle, impetigo, herpes simplex, herpes zoster, herpes simplex dermatitis
(eczema herpeticum), molluscum contagiosum, hudpapillomer, reaktioner ved applikationsstedet så som udslæt, smerter, paræstesier, desquamatio, tørhed, ødem og forværret tilstand.
(eczema herpeticum), molluscum contagiosum, skin papilloma, application site disorders such as rash, pain, paraesthesia, desquamation, dryness, oedema, and condition aggravated.
Alkoholintolerance (i de fleste tilfælde, Ansigtsrødme, udslæt, brændende
- rare: alcohol intolerance (in most cases, flushing, rash, burning, itching or swelling occurred
fornemmelse, kløe eller hævelse kort efter alkoholindtagelse) og allergiske hudreaktioner (f. eks. eksem og nældefeber).
shortly after the intake of alcohol), allergic skin reactions (e.g.dermatitis, urticaria).
Efter markedsføring:
Post marketing:
4. 4).
Cases of malignancy, including cutaneous and other types of lymphoma, and skin cancers, have been reported in patients using pimecrolimus cream (See Section 4.4).
15
15 4.9 Overdose
5.
There has been no experience of overdose with < Invented Name >.
FARMAKOLOGISKE EGENSKABER
No incidents of accidental ingestion have been reported.
D11AX15
D11AX15
Non- klinisk farmakologi Pimecrolimus er et lipofilt, anti- inflammatorisk ascomycinmacrolactamderivat og en celleselektiv hæmmer af dannelsen og frigørelsen af pro- inflammatoriske cytokiner.
Non-clinical pharmacology Pimecrolimus is a lipophilic anti-inflammatory ascomycin macrolactam derivative and a cell selective inhibitor of the production and release of pro-inflammatory cytokines.
Pimecrolimus bindes med høj affinitet til macrofilin- 12 og hæmmer den calciumafhængige fosfatase calcineurin.
Pimecrolimus binds with high affinity to macrophilin-12 and inhibits the calcium-dependent phosphatase calcineurin.
Derved blokeres syntesen af inflammatoriske cytokiner i T- celler.
As a consequence, it blocks the synthesis of inflammatory cytokines in T cells.
Pimecrolimus udviser efter topikal og systemisk applikation høj anti- inflammatorisk aktivitet i dyremodeller af hudinflammation.
Pimecrolimus exhibits high anti-inflammatory activity in animal models of skin inflammation after topical and systemic application.
Kliniske data {(Sær) navn} s effekt og sikkerhedsprofil er vurderet hos mere end 2000 patienter, omfattende små børn (≥3 måneder), børn, unge og voksne, i fase II og III undersøgelser.
Clinical data The efficacy and safety profile of < Invented Name > has been evaluated in more than 2,000 patients including infants (≥3 months), children, adolescents, and adults enrolled in phase II and III studies.
Mere end 1500 af disse patienter blev behandlet med {(Sær) navn} og mere end 500 blev behandlet med kontrolbehandling, det vil sige enten {(Sær) navn} vehiklet og/ eller topikale kortikosteroider.
Over 1,500 of these patients were treated with < Invented Name > and over 500 were treated with control treatment i.e. either < Invented Name > vehicle and/or topical corticosteroids.
Der er udført to 6- ugers, vehikelkontrollerede undersøgelser, inkluderende ialt 403 pædiatriske patienter i alderen 2- 17 år.
Two 6-week, vehicle-controlled trials were conducted including a total of 403 paediatric patients aged 2 to 17 years.
Patienterne blev behandlet 2 gange daglig med {(Sær) navn}.
Patients were treated twice daily with < Invented Name >.
Små børn:
Infants:
Der er udført lignende 6- ugers undersøgelse med 186 patienter i alderen 3- 23 måneder.
A similar 6-week study was conducted in 186 patients aged 3-23 months.
I disse tre 6- ugers undersøgelser var effektresultaterne ved endpoint som følger:
In these three 6-week studies, the efficacy results at endpoint were as follows:
Små børn
Infants
{(Sær) navn} Vehikel p- værdi
< Invente
{(Sær) navn}
Vehicle p-value < Invente Vehicle
Vehikel
p-value
1% (N=136) (N=267)
d Name > (N=136) 1% (N=267)
1% (N=123)
d Name > 1% (N=123)
(N=63)
(N=63)
IGA *:
IGA*:
IGA *
IGA*
Klar eller næsten klar 1 Forbedring2
Clear or almost clear 1 Improvement 2
34, 8% 18, 4% < 0, 001 59, 9% 33% ikke udført
< 0.001 not done
54, 5% 68%
54.5% 68%
23, 8% 40%
23.8% 40%
< 0, 001 ikke udført
< 0.001 Not done
Pruritus:
Pruritus:
EASI°:
EASI°:
Ingen eller mild Total (gennemsnitlig ændring i%) 3
Absent or mild Overall (mean% change)3
56, 6% 33, 8% < 0, 001 - 43, 6 - 0, 7 < 0, 001
56.6% 33.8% -43.6 -0.7
72, 4% - 61, 8
< 0.001 72.4% < 0.001 -61.8
33, 3% +7, 35
33.3% +7.35
Hoved/ nakke (gennemsnitlig ændring i%) 3
Head/Neck (mean% change)3
< 0, 001 - 74, 0
< 0.001
+31, 48 < 0, 001
< 0.001
* Global Investigator Vurdering (Investigators Global Assessment) ° Indeks vedrørende sværhedsgrad af det eksematøse område (Eczema Area Severity Index): gennemsnitlig ændring i% i kliniske tegn (erythem, infiltration, excoriatio, lichenisatio) samt afficeret legemsoverfladeareal.
* Investigators Global Assessment ° Eczema Area Severity Index (EASI): mean% change in clinical signs (erythema, infiltration, excoriation, lichenification) and body surface area involved 1: p-value based on CMH test stratified by centre 2 Improvement=lower IGA than at baseline 3: p-value based on ANCOVA model of EASI at Day 43 endpoint, with centre and treatment as factors and baseline (Day 1) EASI a covariate;
{(Sær) navn} var mindre effektivt end 0, 1% betamethason- 17- valerat til korttidsbehandling (3 uger) hos voksne med moderat til svær atopisk dermatitis.
Adults: < Invented Name > was less effective than 0.1% betamethasone-17-valerate in the short-term treatment (3 weeks) of adults with moderate to severe atopic dermatitis.
{(Sær) navn} blev undersøgt som basisbehandling.
Long-term treatment Two double-blind studies of long-term management of atopic dermatitis were undertaken in 713 children and adolescents (2-17 years) and 251 infants (3-23 months). < Invented Name > was evaluated as foundation therapy.
{(Sær) navn} blev anvendt ved første tegn på kløe eller rødme med henblik på at forhindre progression til opblussen af atopisk dermatitis.
< Invented Name > was used at first signs of itching and redness to prevent progression to flares of atopic dermatitis.
Kun i tilfælde af manglende kontrol af opblussen til svær sygdom med {(Sær) navn}, initieredes behandling med topikalt kortikosteroid af middel styrke.
Only in case of a flare of severe disease not controlled by < Invented Name >, treatment with medium potency topical corticosteroids was initiated.
Ved initiering af kortikosteroidbehandling ved opblussen, blev behandling med {(Sær) navn} seponeret.
When corticosteroid therapy was initiated for the treatment of flares, < Invented Name > therapy was discontinued.
Kontrolgruppen blev behandlet med {(Sær) navn} vehiklet for at opretholde blindingen.
The control group received < Invented Name > vehicle in order to maintain blinding.
Behandling med {(Sær) navn} viste bedre effekt i alle sekundære målinger (EASI, IGA, patientens egen vurdering); pruritus blev afhjulpet inden for 1 uges behandling med {(Sær) navn}.
Both studies showed a significant reduction in the incidence of flares (p < 0.001) in favour of < Invented Name > treatment; < Invented Name > treatment showed better efficacy in all secondary assessments (Eczema Area Severity Index, Investigators Global Assessment, subject assessment); pruritus was controlled within a week with < Invented Name >.
Flere patienter behandlet med {(Sær) navn} gennemførte 6 måneders (børn [61% {(Sær) navn} vs 34% kontrol]; små børn [70% {(Sær) navn} vs 33% kontrol]) og 12 måneders behandling uden opblussen (børn [51% {(Sær) navn} vs 28% kontrol]; små børn [57% {(Sær) navn} vs 28% kontrol]).
More patients treated with < Invented Name > completed 6 months [children (61% < Invented Name > vs 34% control), infants (70% < Invented Name > vs 33% control)] and 12 months with no flare [children (51% < Invented Name > vs 28% control), infants (57% < Invented Name > vs 28% control)].
35% kontrol)].
< Invented Name > had a sparing effect on the use of topical corticosteroids: more patients treated with < Invented Name > did not use corticosteroids in 12 months [children (57% < Invented Name > vs 32% control), infants (64% < Invented Name > vs 35% control)].
Effekten af {(Sær) navn} blev opretholdt over tid.
The efficacy of < Invented Name > was maintained over time.
En 6- måneders randomiseret, dobbelt- blind, parallel, vehikelkontrolleret undersøgelse af tilsvarende design blev udført med 192 voksne med moderat til svær atopisk dermatitis.
A 6-month randomized, double-blind, parallel group, vehicle-controlled study of similar design was performed in 192 adults with moderate to severe atopic dermatitis.
I den 24- ugers behandlingsperiode anvendte {(Sær) navn} gruppen topikalt kortikosteroid i 14, 2 ± 24, 2% af dagene og kontrolgruppen i 37, 2 ± 34, 6% af dagene (p < 0, 001).
A total of 50.0% of the patients treated
Ialt 50, 0% af patienterne behandlet med {(Sær) navn} oplevede ingen opblussen sammenlignet med 24, 0% af patienterne randomiseret til kontrolgruppen.
17 with < Invented Name > did not experience any flare compared with 24.0% of the patients randomized to the control group.
Der er udført en 1- årig dobbelt- blind undersøgelse hos voksne med moderat til svær atopisk dermatitis med henblik på at sammenligne {(Sær) navn} med 0, 1% triamcinolonacetonidcreme (til krop og ekstremiteter) plus 1% hydrocortisonacetatcreme (til ansigt, hals og intertrigenøse områder).
A one year double-blind study in adults with moderate to severe atopic dermatitis was conducted to compare < Invented Name > to 0,1% triamcinolone acetonide cream (for trunk and extremities) plus 1% hydrocortisone acetate cream (for face, neck and intertriginous areas).
Både {(Sær) navn} og de topikale kortikosteroider blev anvendt uden restriktioner.
Both < Invented Name > and topical corticosteroids were used without restrictions.
{(Sær) navn} var mindre effektivt end 0, 1% triamcinolonacetonidcreme (til krop og ekstremiteter) plus 1% hydrocortisonacetatcreme (til ansigt, hals og intertrigonøse områder) ved langtidsbehandling (52 uger) af voksne med moderat til svær atopisk dermatitis.
Half of the patients in the control group received topical corticosteroids for more than 95% of study days. < Invented Name > was less effective than 0,1% triamcinolone acetonide cream (for trunk and extremities) plus 1% hydrocortisone acetate cream (for face, neck and intertriginous areas) in the long-term treatment (52 weeks) of adults with moderate to severe atopic dermatitis.
17 Applikationshyppighed over 2 gange daglig er ikke undersøgt.
Frequency of application greater than twice daily has not been studied.
Specialundersøgelser {(Sær) navn} har i tolerabilitetsundersøgelser ikke vist kontaktsensitiverende, fototoksisk eller fotosensitiverende potentiale eller nogen kumulativ irritation.
Tolerability studies demonstrated that < Invented Name > has not shown contact sensitising, phototoxic or photosensitising potential, nor did they show any cumulative irritation.
{(Sær) navn} s atrofiinducerende potentiale hos mennesker er sammenlignet med middel - og højpotente topikale steroider (betamethason- 17- valerat 0, 1% creme, triamcinolonacetonid 0, 1% creme) og vehikel hos 16 raske frivillige behandlet i 4 uger.
The atrophogenic potential of < Invented Name > in humans was tested in comparison to medium and highly potent topical steroids (betamethasone-17-valerate 0.1% cream, triamcinolone acetonide 0.1% cream) and vehicle in sixteen healthy volunteers treated for 4 weeks.
Begge topikale kortikosteroider inducerede betydelig reduktion i hudtykkelse målt ved ekkografi, sammenlignet med {(Sær) navn} og vehikel, som ikke inducerede reduktion i hudtykkelsen.
Both topical corticosteroids induced a significant reduction in skin thickness measured by echography, as compared to < Invented Name > and vehicle, which did not induce a reduction of skin thickness.
Dyredata Biotilgængeligheden af pimecrolimus i mini- grise efter en enkelt dermal dosis (administreret i 22 timer under semi- okklusion) var 0, 03%.
Data in animals The bioavailability of pimecrolimus in mini-pigs following a single dermal dose (applied for 22h under semi-occlusion) was 0.03%.
Absorption hos voksne Systemisk optagelse af pimecrolimus er undersøgt hos 12 voksne med atopisk dermatitis behandlet med {(Sær) navn} 2 gange daglig i 3 uger.
Absorption in adults Systemic exposure to pimecrolimus was investigated in 12 adults with atopic dermatitis who were treated with < Invented Name > twice daily for 3 weeks.
BSA (påvirket areal af legemsoverfladen) varierede fra 15 - 59%.
The affected body surface area (BSA) ranged from 15-59%.
77, 5% af pimecrolimus blodkoncentrationerne var under 0, 5 ng/ ml, og 99, 8% af de samlede prøver var under 1 ng/ ml.
77.5% of pimecrolimus blood concentrations were below 0.5 ng/ml and 99.8% of the total samples were below 1 ng/ml.
Den højeste pimecrolimus- blodkoncentration målt hos én patient var 1, 4 ng/ ml.
The highest pimecrolimus blood concentration was 1.4 ng/ml in one patient.
Hos 40 voksne patienter behandlet i op til 1 år med {(Sær) navn} og med 14- 62% afficeret BSA ved baseline, var 98% af blodkoncentrationerne under 0, 5 ng/ ml.
In 40 adult patients treated for up to 1 year with < Invented Name >, having 14-62% of their BSA affected at baseline, 98% of pimecrolimus blood concentrations were below 0.5 ng/ml.
Kun hos 2 patienter sås en maksimal blodkoncentration på 0, 8 ng/ ml i undersøgelsens behandlingsuge 6.
A maximum blood concentration of 0.8 ng/ml was measured in only 2 patients in week 6 of treatment.
Hos 8 voksne patienter med atopisk dermatitis, hvor AUC- niveauerne kunne kvantificeres, varierede AUC( 0- 12 timer) fra 2, 5- 11, 4 ng· t/ ml.
In 8 adult atopic dermatitis patients, in which AUC levels could be quantified, the AUC (0-12h) values ranged from 2.5 to 11.4 ng h/ml.
Absorption hos børn Systemisk optagelse af pimecrolimus blev undersøgt hos 58 pædiatriske patienter i alderen 3 måneder til 14 år.
Absorption in children Systemic exposure to pimecrolimus was investigated in 58 paediatric patients aged 3 months to 14 years.
Det afficerede BSA varierede fra 10- 92%.
The affected BSA ranged from 10-92%.
Børnene blev behandlet med {(Sær) navn} 2 gange daglig i 3 uger, og 5 af dem blev behandlet i op til 1 år på ” efter behov ” basis.
These children were treated with < Invented Name > twice daily for 3 weeks and five out of them were treated for up to 1 year on a “as needed” basis.
Pimecrolimus- blodkoncentrationerne var vedvarende lave, uanset graden af den behandlede læsion og varighed af behandlingen.
18 Pimecrolimus blood concentrations were consistently low regardless of the extent of lesions treated or duration of therapy.
60% af pimecrolimus- blodkoncentrationerne var under 0, 5 ng/ ml, og 97% af alle prøver var under 2 ng/ ml.
Around 60% of pimecrolimus blood concentrations were below 0.5 ng/ml and 97% of all samples were below 2 ng/ml.
De højeste blodkoncentrationer målt hos 2 pædiatriske patienter i alderen 8 måneder til 14 år var 2, 0 ng/ ml.
The highest blood concentrations measured in 2 paediatric patients aged 8 months to 14 years were 2.0 ng/ml.
Hos små børn (i alderen 3- 23 måneder) var den højest målte blodkoncentration, målt hos én patient, 2, 6 ng/ ml.
In infants (aged 3 to 23 months), the highest blood concentration measured in one patient was 2.6 ng/ml.
Hos de 5 børn der blev behandlet i 1 år, var blodkoncentrationerne vedvarende lave (højeste blodkoncentration var 1, 94 ng/ ml hos én patient).
In the 5 children treated for 1 year, blood concentrations were consistently low (maximum blood concentration was 1.94 ng/ml in 1 patient).
Der sås ingen stigning i blodkoncentrationen over tid hos nogen af patienterne igennem de 12 måneders behandling.
There was no increase in blood concentration over time in any patient during the 12 months of treatment.
Hos 8 pædiatriske patienter i alderen 2- 14 år varierede AUC (0- 12 timer) fra 5, 4 til 18, 8 ng· t/ ml.
In 8 paediatric patients aged 2-14 years, AUC (0-12h) ranged from 5.4 to 18.8 ng h/ml.
AUC- værdier hos patienter med < 40% afficeret BSA ved baseline var sammenlignelige med værdier hos patienter med ≥40% BSA.
AUC ranges observed in patients with < 40% BSA affected at baseline were comparable to those in patients with ≥40% BSA.
18 Fordeling, metabolisme og udskillelse Blodkoncentrationer af pimecrolimus efter topikal administration er, i overensstemmelse med hudselektiviteten, meget lave.
Distribution, Metabolism, and Excretion Consistent with its skin selectivity, after topical application, pimecrolimus blood levels are very low.
Pimecrolimus ’ metabolisme efter topikal administration kan derfor ikke fastlægges.
Therefore pimecrolimus metabolism could not be determined after topical administration.
Efter enkelt oral administration af radiomærket pimecrolimus til raske frivillige, udgjorde uomdannet pimecrolimus den største aktiv substansrelaterede bestanddel i blodet, og der var flere mindre metabolitter af moderat polaritet, som synes at være produkter af O- demethyleringer og oxydering.
After single oral administration of radiolabeled pimecrolimus in healthy subjects, unchanged pimecrolimus was the major active substance-related component in blood and there were numerous minor metabolites of moderate polarity that appeared to be products of O-demethylations and oxygenation.
Aktiv substansrelateret radioaktivitet blev primært udskilt via fæces (78, 4%) og kun en lille del (2, 5%) blev genfundet i urinen.
Active substance-related radioactivity was excreted principally via the faeces (78.4%) and only a small fraction (2.5%) was recovered in urine.
Gennemsnitlig genfunden radioaktivitet var totalt 80, 9%.
Total mean recovery of radioactivity was 80.9%.
Embryo/ føtale udviklingsundersøgelser med dermal applikation til rotter og kaniner samt karcinogenicitetsundersøgelser med mus og rotter var negative.
Dermal application in embryo/fetal developmental studies in rats and rabbits and in carcinogenicity studies in mice and rats were negative.
Der er set påvirkning af de reproduktive organer og ændret kønshormonfunktion hos han - og hunrotter i undersøgelser vedrørende gentagen dosistoksicitet efter peroral administration af 10 og 40 mg/ kg/ dag (= 20- 60 gange den maksimale humane optagelse efter dermal applikation).
Effects on reproductive organs and altered sex hormone functions were seen in male and female rats in repeated dose toxicity studies after oral administration of 10 or 40 mg/kg/day (= 20 to 60 times the maximum human exposure after dermal application).
NOAEL (No Observed Adverse Effect Level) for fertiliteten hos hundyr var 10 mg/ kg/ dag (= 20 gange den maksimale humane optagelse efter dermal applikation).
The No Observed Adverse Effect Level (NOAEL) for female fertility was 10 mg/kg/day (= 20 times the maximum human exposure after dermal application).
I orale embryotoksicitetsundersøgelser med kaniner, sås højere resorptionsrate i forbindelse med maternel toksicitet ved 20 mg/ kg/ dag (=7 gange den maksimale humane optagelse efter dermal applikation); det gennemsnitlige antal af levende fostre var uændret.
In the oral embryotoxicity study in rabbits, a higher resorption rate associated with maternal toxicity was observed at 20 mg/kg/day (= 7 times the maximum human exposure after dermal application); the mean number of live fetuses was not affected.
Der blev set tegn på bedring og/ eller i det mindste delvis reversibilitet af effekten ved ophør af indgift hos nogle få dyr.
Signs of recovery and/or at least partial reversibility of the effects were noted upon cessation of dosages in a few animals.
At det ikke lykkedes at opnå et NOAEL udelukker en vurdering af sikkerhedsmargin mellem en ikke- carcinogen koncentration hos aber og eksponering hos patienter.
Failure to derive a NOAEL precludes an assessment of the margin of safety between a non-carcinogenic concentration in the monkey and exposures in patients.
Den systemiske eksponering ved LOAEL på 15 mg/ kg/ dag var 31 gange højere end den højeste maksimale eskponering, som er set hos mennesker (pædiatrisk patient).
The risk for humans cannot be completely ruled
Risiko for mennesker kan ikke udelukkes fuldstændigt, da potentialet for lokal immunsuppression ved langtidsbrug af pimecrolimus ikke er kendt.
19 out as the potential for local immunosuppression with the long-term use of pimecrolimus cream is unknown.
Triglycerider, middelkædelængde Oleylalkohol Propylenglycol Stearylalkohol Cetylalkohol Mono - og diglycerider Natriumcetostearylsulfat
Medium chain triglycerides Oleyl alcohol Propylene glycol Stearyl alcohol Cetyl alcohol Mono-and di-glycerides Sodium cetostearyl sulphate Benzyl alcohol Citric acid anhydrous Sodium hydroxide Purified water
Efter anbrud:
After first opening the container:
Aluminiumstube med beskyttende fenolepoxy- inderlak og polypropylenskruehætte.
Aluminium tube with a phenol-epoxy protective inner lacquer and polypropylene screw cap.
6. 6 Særlige forholdsregler ved bortskaffelse
6.6 Instructions for use and handling
4. 2 ” Dosering og indgivelsesmåde ”).
Emollients can be applied together with < Invented Name > (see Section 4.2 “Posology and method of administration”).
DATO FOR ÆNDRING AF TEKSTEN
MARKETING AUTHORISATION NUMBER(S)
20 ETIKETTERING OG INDLÆGSSEDDEL
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21 ETIKETTERING
21 LABELLING AND PACKAGE LEAFLET
22 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
22 LABELLING
{(Sær) navn} 1% creme
< {(Invented) name strength pharmaceutical form} >
< {(sær) navn og tilhørende navne (Se bilag I) styrke lægemiddelform} > < [Se bilag I - Udfyldes nationalt] >
< {(Invented) name and associated names (see Annex I) strength pharmaceutical form} > < [See Annex I - To be completed nationally] > [For referral procedures]
Pimecrolimus
Pimecrolimus