natgillin/translations-raw huggingface dataset:
På grund af risikoen for manglende effekt at vaccinationer, bør man vaccinere før start på behandling eller i behandlingsfri intervaller med en periode på 14 dage mellem den sidste påsmøring af Protopic salve og vaccination.
Because of the potential risk of vaccination failure, vaccination should be administered prior to commencement of treatment, or during a treatment-free interval with a period of 14 days between the last application of Protopic and the vaccination.
5. 3).
Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3).
Protopic salve bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
Protopic ointment should not be used during pregnancy unless clearly necessary.
Selv om den systemiske eksponering er lav ved brug af Protopic salve bør kvinder i behandling med Protopic salve ikke amme.
Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Protopic ointment is not recommended.
Der er ikke foretaget undersøgelser af indflydelsen på evnen til at føre bil eller betjene maskiner.
4 No studies on the effects on the ability to drive and use machines have been performed.
Da Protopic salve benyttes lokalt, er det usandsynligt, at det påvirker evnen til at føre bil eller betjene maskiner.
Protopic ointment is administered topically and is unlikely to have an effect on the ability to drive or use machines.
Dette svinder sædvanligvis i løbet af en uge efter behandlingens start.
Burning sensation and pruritus were very common, usually mild to moderate in severity and tended to resolve within one week of starting treatment.
Hyppigheden er defineret som meget almindelig (> 1/ 10), almindelig (> 1/ 100, < 1/ 10) og usædvanlig (> 1/ 1. 000, < 1/ 100).
Frequencies are defined as very common (> 1/ 10), common (> 1/ 100 ,< 1/10) and uncommon (> 1/1 ,000, < 1/100).
Brænden på applikationsstedet, kløe på applikationsstedet Almindelig:
Common:
Varme på applikationsstedet, erythem på applikationsstedet, smerte på applikationsstedet, irritation på applikationsstedet, paræstesi på applikationsstedet, udslæt på applikationsstedet
Application site burning, application site pruritus Application site warmth, application site erythema, application site pain, application site irritation, application site paraesthesia, application site rash
Infektiøse og parasitære sygdomme Almindelig:
Infections and infestations Common:
Herpes virus infektioner (herpes simplex dermatitis [eczema herpeticum], herpes simplex [forkølelsessår], Kaposi' s varicelliforme eruption)
Herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi’ s varicelliform eruption)
Folliculitis, pruritus Acne
Folliculitis, pruritus Acne
Paræstesi og dysæstesi (hyperæsthesi brændende følelse)
Paraesthesias and dysaesthesias (hyperaesthesia, burning sensation)
Stofskiftesygdomme og ernæringsbetingede sygdomme Almindelig:
Metabolism and nutrition disorders Common:
Følgende bivirkninger er blevet rapporteret efter markedsføringen:
The following adverse reactions have been reported during post-marketing experience:
Sygdomme i hud og subkutant væv:
Skin and subcutaneous tissue disorders:
Rosacea
Rosacea
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).
Farmakoterapeutisk klassifikation:
5 Pharmacotherapeutic group:
Dermatologiske midler, andre, ATC- kode:
Other dermatologicals, ATC code:
Virkningsmekanisme og farmakodynamisk effekt Tacrolimus virkningsmekanisme i atopisk dermatitis er ikke fuldt klarlagt.
Mechanism of action and pharmacodynamic effects The mechanism of action of tacrolimus in atopic dermatitis is not fully understood.
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 IL- 2, IL- 3, IL- 4, IL- 5 og andre cytokiner som GM- CSF, TNF- α og IFN- γ.
Via its binding to a specific cytoplasmic immunophilin (FKBP12), tacrolimus inhibits calcium- 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.
In vitro reducerer tacrolimus den stimulerende effekt på T- celler i Langerhans celler isoleret fra normal human hud.
In vitro, in Langerhans cells isolated from normal human skin, tacrolimus reduced the stimulatory activity towards T cells.
Hos patienter med atopisk dermatitis var bedringen af hudlæsioner under salvebehandling med tacrolimus ledsaget at reduceret Fc receptor expression på Langerhanske celler og en reduktion af deres hyperstimulerende effekt på T- celler.
In patients with atopic dermatitis, improvement of skin lesions during treatment with tacrolimus ointment was associated with reduced Fc receptor expression on Langerhans cells and a reduction of their hyperstimulatory activity towards T cells.
Resultater fra kliniske studier med patienter Effekt og tolerabilitet er blevet undersøgt i mere end 13. 500 patienter behandlet med tacrolimus salve i fase I til fase III kliniske afprøvninger.
Results from clinical studies in patients The efficacy and safety of Protopic was assessed in more than 13,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
I en seks- måneders multicenter, dobbelt- blind, randomiseret afprøvning blev 0, 1% tacrolimus salve administreret 2 gange om dagen til voksne med moderat til svær atopisk dermatitis, og blev sammenlignet med lokal kortikosteroid behandling (0, 1% hydrokortison butyrat på kroppen og ekstremiteter og 1% hydrokortison acetat på ansigt og hals).
In a six-month multicentre double-blind randomised trial, 0.1% tacrolimus ointment was administered 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% hydrocortisone acetate on face and neck).
Respons raten i 0, 1% tacrolimus gruppen (71, 6%) var signifikant højere end den i gruppen med lokal kortikosteroid behandling (50, 8%, p < 0, 001; Tabel 1).
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).
Effekt ved måned 3
Efficacy at month 3
Tacrolimus 0, 1% (N=487)
Tacrolimus 0.1% (N=487)
Respons rate på ≥ 60% bedring i mEASI (Primær parameter) §§
Response rate of ≥ 60% improvement in mEASI (Primary Endpoint)§§
Forbedring ≥ 90% i lægens samlede vurdering
Improvement ≥ 90% in Physician’ s 28.5% Global Evaluation
§ Lokal kortikosteroidbehandling = 0, 1% hydrokortison butyrat på krop og ekstremiteter, 1% hydrokortison acetat på ansigt og hals. §§ højere værdi = større bedring
§ Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck §§ higher values = greater improvement
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 eller 1% hydrokortison acetat salve.
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% hydrocortisone acetate ointment.
Resultaterne af denne
The primary endpoint was the area-under-the-curve (AUC) of the mEASI as a percentage of baseline averaged over the treatment period.
6 multicenter, dobbelt- blinde, randomiserede afprøvning viste at tacrolimus salve, 0, 03% og 0, 1% har signifikant bedre effekt (p < 0, 001 for begge) end 1% hydrokortison acetat salve (Tabel 2).
The results of this multicentre, 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).
Tabel 2
6 Table 2
Effekt ved uge 3
Efficacy at week 3
Tacrolimus 0, 03% (N=189)
Tacrolimus 0.03% (N=189)
Tacrolimus 0, 1% (N=186)
Tacrolimus 0.1% (N=186)
som procent af
as Percentage of
baseline mean AUC (Primær parameter) § 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
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 atopisk dermatitis.
The purpose of the third multicentre, double-blind, randomised study was the assessment of efficacy 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 dermatitis.
Hydrokortison acetat 1% 2 gange om dagen (N = 207)
Hydrocortisone acetate 1% Twice daily (N=207)
Tacrolimus 0, 03% En gang om dagen (N=207)
Tacrolimus 0.03% Once daily (N=207)
Tacrolimus 0, 03% To gange om dagen (N=210)
Tacrolimus 0.03% Twice daily (N=210)
Procent fald median mEASI
Median mEASI
i 47, 2%
47.2%
(Primær parameter) § Bedring ≥ 90% i lægens 13, 6% samlede vurdering § højere værdi = større bedring
Decrease (Primary Endpoint)§ Improvement ≥ 90% in Physician’ s Global Evaluation
27, 8%
13.6%
36, 7%
27.8%
Den primære parameter var defineret som den procentvise
36.7%
formindskelse af mEASI fra
§ higher values = greater improvement
indtil afslutning af behandlingen.
The primary endpoint was defined as the percentage decrease in mEASI from the baseline to end of treatment.
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 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 both).
0, 03% tacrolimus salve 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).
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 patienter der blev behandlet i mindst 3 år og 79 patienter der blev behandlet i mindst 42 måneder.
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 patients receiving treatment for at least three years and 79 patients receiving treatment for a minimum of 42 months.
De tre mest almindelige bivirkninger, der blev rapporteret, var influenzalignende symptomer (snue, forkølelse, influenza, infektioner i de øvre luftveje o. s. v.) kløe og en brændende fornemmelse i huden.
The three most common adverse events reported were flu-like symptoms (cold, common cold, influenza, upper respiratory infection, etc.), pruritus and skin burning.
Man så i dette langtidsstudie ingen bivirkninger, der ikke var rapporteret ved kortere behandlingstid og/ eller tidligere studier.
No adverse events previously unreported in shorter duration and/ or previous studies were observed in this long-term study.
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.
7 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.
Flertallet af de patienter med atopisk dermatitis (voksne og børn), der er blevet behandlet med en enkelt eller med gentagen applikation af tacrolimus salve (0, 03 - 0, 1%), og spædbørn fra 5 måneders alderen behandlet med tacrolimus salve (0, 03%), havde blodkoncentrationer < 1, 0 ng/ ml.
Most atopic dermatitis patients (adults and children) treated with single or repeated application of tacrolimus ointment (0.03 - 0.1%), and infants from age of 5 months treated with tacrolimus ointment (0.03%) had blood concentrations < 1.0 ng/ ml.
I de tilfælde man fandt blodkoncentrationer > 1 ng/ ml var disse kun af kort varighed.
When observed, blood concentrations exceeding 1.0 ng/ ml were transient.
Hos både voksne og børn, der får behandlet 50% af kroppens overflade, er den systemiske eskponering (dvs AUC) af tacrolimus fra Protopic cirka 30- gange mindre end hvad man finder ved orale immunosuppressive doser i nyre - og levertransplanterede patienter.
AUC) of tacrolimus from Protopic 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 plasmabinding af tacrolimus (> 98, 8%) næppe klinisk relevant.
Distribution As systemic exposure is low with tacrolimus ointment, the high binding of tacrolimus (> 98.8%) to plasma proteins is considered not to be clinically relevant.
Metabolisme Der er ikke tegn på, at tacrolimus metaboliseres af human hud.
Metabolism Metabolism of tacrolimus by human skin was not detectable.
Eliminering Efter intravenøs administrering er tacrolimus vist at være et stof med lav clearance.
Elimination When administered intravenously, tacrolimus has been shown to have a low clearance rate.
Den gennemsnitlige totale clearance fra kroppen er omkring 2, 25 l/ time.
The average total body clearance is approximately 2.25 l/ h.
Kronisk toksicitet og lokal tolerabilitet Gentagen lokal administrering af enten tacrolimus salve eller af salvegrundlag til rotter, kaniner og minigrise medførte lettere dermale ændringer så som erythem, ødem og papler.
Repeated dose toxicity and local tolerance Repeated topical administration of tacrolimus ointment or the ointment vehicle to rats, rabbits and micropigs was associated with slight dermal changes such as erythema, oedema and papules.
Mutagenicitet Med relevante in vitro og in vitro tests har man ikke kunnet påvise tegn på mutagent potentiale af tacrolimus.
Mutagenicity In vitro and in vivo tests did not indicate a genotoxic potential of tacrolimus.
8 Carcinogenicitet Systemiske carcinogenicitets undersøgelser i mus (18 måneder) og rotter (24 måneder) viste ingen tegn på tumorogent potentiale.
Carcinogenicity Systemic carcinogenicity studies in mice (18 months) and rats (24 months) revealed no carcinogenic potential of tacrolimus.
Man fandt ingen hudtumorer i en 24 måneders undersøgelse af dermal carcinogenicitet på mus hvor man benyttede 0, 1% salve.
In a 24-month dermal carcinogenicity study performed in mice with 0.1% ointment, no skin tumours were observed.
Dyr, der fik behandling med tacrolimus salven viste en signifikant reduceret tid indtil udvikling af hudtumorer (planocellulære carcinomer) samt et øget antal tumorer.
Animals treated with tacrolimus ointment showed a statistically significant reduction in time to skin tumour (squamous cell carcinoma) development and an increase in the
Teratogenicitet I rotter og kaniner ses embryo/ føtal toksisk effekt, men kun i doser der har signifikant toksisk effekt på moderdyret.
Reproduction toxicity Embryo/ foetal toxicity was observed in rats and rabbits, but only at doses that caused significant toxicity in maternal animals.
Laminat tube med en inderbeklædning af low- density- polyætylen lukket med et hvidt polypropylen skruelåg.
Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene screw cap.
10 g, 30 g og 60 g.
10 g, 30 g and 60 g.
61 D- 81673 München Tyskland
61 D-81673 München Germany
28/ 02/ 2002 Dato for fornyelse:
28/ 02/ 2002 Date of renewal:
{DD/ MM/ ÅÅÅÅ}
{DD/ MM/ YYYY}
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Protopic 0, 1% salve
Protopic 0.1% ointment
1 g Protopic 0, 1% salve indeholder 1, 0 mg tacrolimus som tacrolimus monohydrat (0, 1%).
1 g of Protopic 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
Protopic er ikke anbefalet til brug hos børn under 2 år før yderligere data er tilgængelige
Protopic is not recommended for use in children below age of 2 years until further data are available.
Behandling af ældre (65 år gamle og ældre) Der er ikke blevet foretaget specielle studier med ældre patienter.
Use in elderly (65 years of age and above) Specific studies have not been conducted in elderly patients.
11 4. 3 Kontraindikationer
11 As clinical efficacy studies were performed with abrupt cessation of treatment, no information is available on whether tapering of the dosage would reduce recurrence rate.
5. 2).
12 Tacrolimus is extensively metabolised in the liver and although blood concentrations are low following topical therapy, the ointment should be used with caution in patients with hepatic failure (see section 5.2).
Alkohol intolerance (flushing eller hudirritation efter indtagelse af en alkoholisk drik) er også almindelig.
Sensation of warmth, pain, paraesthesia and rash at the site of
13 Patienterne har muligvis en forhøjet risiko for folliculitis, akne og virusinfektioner.
Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common.
In vitro reducerer tacrolimus den stimulerende effekt på T- celler i Langerhans celler isoleret fra normal human hud.
14 In vitro, in Langerhans cells isolated from normal human skin, tacrolimus reduced the stimulatory activity towards T cells.
14 I dyr undertrykker tacrolimus salve inflammatoriske reaktioner i eksperimentelle og spontane dermatitismodeller, der ligner den humane atopiske dermatitis.
In animals, tacrolimus ointment suppressed inflammatory reactions in experimental and spontaneous dermatitis models that resemble human atopic dermatitis.
Den primære parameter var area- under- the curve (AUC) af mEASI som procent af baseline mean værdien i behandlingsperioden.
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 signifikant bedre effekt (p < 0, 001 for begge) end 1% hydrokortison acetat salve (Tabel 2).
The results of this multicentre, 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).
Tabel 2
15 Table 2
15 Incidensen af brændende følelse i huden var højere i gruppen der blev behandlet med tacrolimus end i hydrokortison gruppen.
The incidence of local skin burning was higher in the tacrolimus treatment groups than in the hydrocortisone group.
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.
Absorption Data from healthy human subjects indicate that there is little or no systemic exposure to tacrolimus 16 following single or repeated topical application of tacrolimus ointment.
Hos både voksne og børn, der får behandlet 50% af kroppens
In both adults and children with an average of 50% body surface area treated, systemic exposure (i. e.
16 overflade, er den systemiske eskponering (dvs AUC) af tacrolimus fra Protopic cirka 30- gange mindre end hvad man finder ved orale immunosuppressive doser i nyre - og levertransplanterede patienter.
AUC) of tacrolimus from Protopic is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
Carcinogenicitet Systemiske carcinogenicitets undersøgelser i mus (18 måneder) og rotter (24 måneder) viste ingen tegn på tumorogent potentiale.
Carcinogenicity Systemic carcinogenicity studies in mice (18 months) and rats (24 months) revealed no carcinogenic potential of tacrolimus.
Det er uklart om effekten skyldes en systemisk immunosuppression eller en lokal effekt.
17 immunosuppression or a local effect.
{DD/ MM / ÅÅÅÅ}
{DD/ MM/ YYYY}
INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
20 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Kerry, Irland
Kerry, Ireland
PROTOPIC 0, 03% SALVE (10 g, 30 g, 60 g YDRE EMBALLAGE)
PROTOPIC 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
Protopic 0, 03% Salve Tacrolimus monohydrat
Protopic 0.03% Ointment Tacrolimus monohydrate
1 g salve indeholder:
1 g ointment contains:
0, 3 mg tacrolimus (som monohydrat),
0.3 mg tacrolimus (as monohydrate),
PROTOPIC 0, 03% SALVE (10 g TUBE)
PROTOPIC 0.03% OINTMENT (10 g TUBE)
Protopic 0, 03% Salve Tacrolimus monohydrat Kutan anvendelse
Protopic 0.03% Ointment Tacrolimus monohydrate Cutaneous use
26 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
26 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
PROTOPIC 0, 03% SALVE (30 g, 60 g TUBE)
PROTOPIC 0.03% OINTMENT (30 g, 60 g TUBE)
PROTOPIC 0, 1% SALVE (10 g, 30 g, 60 g YDRE EMBALLAGE)
PROTOPIC 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
Protopic 0, 1% Salve Tacrolimus monohydrat
Protopic 0.1% Ointment Tacrolimus monohydrate
1, 0 mg tacrolimus (som monohydrat),
1.0 mg tacrolimus (as monohydrate),
30 MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
PROTOPIC 0, 1% SALVE (10 g TUBE)
PROTOPIC 0.1% OINTMENT (10 g TUBE)
Protopic 0, 1% Salve Tacrolimus monohydrat Kutan anvendelse
Protopic 0.1% Ointment Tacrolimus monohydrate Cutaneous use
31 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
31 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
PROTOPIC 0, 1% SALVE (30 g, 60 g TUBE)
PROTOPIC 0.1% OINTMENT (30 g, 60 g TUBE)
Protopic 0, 03% salve Tacrolimus monohydrat
Protopic 0.03% Ointment Tacrolimus monohydrate
Hvad Protopic er, og hvad det anvendes til 2.
What Protopic is and what it is used for 2.
Hvad De skal gøre, før De begynder at anvende Protopic 3.
Before you use Protopic 3.
Hvordan De anvender Protopic 4.
How to use Protopic 4.
Hvilke mulige bivirkninger Protopic har 5.
Possible side effects 5.
Hvordan De opbevarer Protopic 6.
How to store Protopic 6.
HVAD PROTOPIC ER, OG HVAD DET ANVENDES TIL
WHAT PROTOPIC IS AND WHAT IT IS USED FOR
Det aktive stof i Protopic, tacrolimus monohydrat, er et immunomodulerende lægemiddel.
The active substance of Protopic, tacrolimus monohydrate, is an immunomodulating agent.
Protopic 0, 03% salve benyttes til at behandle moderat til svær atopisk dermatitis (eksem) hos voksne, der ikke responderer tilfredsstillende på eller ikke tåler konventionelle behandlinger såsom topikale kortikosteroider og til børn (2 år og ældre), der ikke har responderet tilfredsstillende på konventionel behandling såsom topikale kortikosteroider.
Protopic 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids.
Ved atopisk dermatitis ses inflammation af huden (kløe, rødme og tørhed) på grund af en overreaktion af hudens immunsystem.
In atopic dermatitis, an over-reaction of the skin’ s immune system causes skin inflammation (itchiness, redness, dryness).
HVAD DE SKAL GØRE, FØR DE BEGYNDER AT ANVENDE PROTOPIC
BEFORE YOU USE PROTOPIC