natgillin/translations-raw huggingface dataset:
Hvis De tager midler, der indeholder kalk, bør der gå mindst 2 timer, før De tager PROTELOS.
If you are taking medicines containing calcium, you should leave at least 2 hours before you take PROTELOS.
Hvis De får syredæmpende midler (mod halsbrand), skal De helst tage dem mindst 2 timer efter, at De tager PROTELOS.
If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after PROTELOS.
Hvis De skal have antibiotika såsom tetracykliner og quinoloner til indtagelse gennem munden, bør De holde op med at tage PROTELOS.
You should stop taking PROTELOS if you have to take oral tetracyclines or quinolones (two types of antibiotics).
Graviditet PROTELOS er kun beregnet til kvinder, der ikke længere får menstruation.
PROTELOS is meant for use only in postmenopausal women.
PROTELOS bør derfor ikke anvendes under graviditet.
Therefore, PROTELOS should not be taken during pregnancy.
Amning PROTELOS er kun beregnet til kvinder, der ikke længere har menstruation.
PROTELOS is meant for use only in postmenopausal women.
Kvinder, der ammer, bør derfor ikke tage PROTELOS.
Therefore, breast-feeding women should not take this medicine.
Trafik - og arbejdssikkerhed PROTELOS påvirker så vidt vides ikke evnen til at køre eller betjene maskiner.
PROTELOS is not known to affect your ability to drive or use machines.
Vigtig information om nogle af de øvrige indholdsstoffer i PROTELOS PROTELOS indeholder aspartam.
PROTELOS contains aspartame.
Hvis De lider af phenylketonuri (en sjælden arvelig stofskifte - sygdom), bør De tale med lægen, før De begynder at tage lægemidlet.
If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism) talk to your doctor before you start to take this medicine.
SÅDAN SKAL DE TAGE PROTELOS
HOW TO TAKE PROTELOS
Tag altid PROTELOS nøjagtigt efter lægens anvisning.
Always take PROTELOS exactly as your doctor has told you.
PROTELOS er beregnet til oral anvendelse.
PROTELOS is for oral use.
Det anbefales at tage PROTELOS ved sengetid.
It is recommended that you take PROTELOS at bedtime.
De må gerne lægge Dem umiddelbart efter indtagelse af PROTELOS.
You may lie down immediately after taking PROTELOS if you wish.
Lægen vil måske anbefale, at De ud over PROTELOS får kalk - og D- vitamintilskud.
Your doctor may advise you to take calcium and vitamin D supplements in addition to PROTELOS.
De bør ikke tage kalktilskud ved sengetid samtidig med PROTELOS.
Do not take calcium supplements at bedtime, at the same time as PROTELOS.
Deres læge vil oplyse Dem om, hvor længe De bør fortsætte med PROTELOS.
Your doctor will tell you how long you should continue to take PROTELOS.
Hvis De har taget for meget PROTELOS Hvis De tager for mange breve PROTELOS, bør De oplyse det til Deres læge eller apotek.
If you take too many sachets of PROTELOS, tell your doctor or pharmacist.
Hvis De har glemt at tage PROTELOS De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
Do not take a double dose to make up for forgotten individual doses.
PROTELOS kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, PROTELOS can cause side effects, although not everybody gets them.
Følgende bivirkninger er også indberettet af patienter, der tog PROTELOS: opkastning, mavesmerter, irritation i munden (såsom mundsår og tandkødsbetændelse), smerter i knogler, muskler og/ eller led, muskelkramper, overfølsomhedssyndromer (allergiske reaktioner, der omfatter udslæt og feber), kløe, nældefeber og angioødem (såsom hævelser i ansigt, tunge eller hals, besvær med at trække vejret eller synke), hævede fødder, ankler og/ eller hænder, forvirring.
The following side effects have also been reported by patients taking PROTELOS: vomiting, abdominal pain, oral irritation (such as mouth ulcers and gum inflammation), bone, muscle and/ or joint pain, muscle cramps, hypersensitivity syndromes (allergic reactions including rash and fever), itching, hives, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), swelling in limbs, feeling confused.
Hold omgående op med at tage PROTELOS og kontakt lægen, hvis De får symptomer såsom hævelser i ansigt, tunge eller hals, besvær med at trække vejret eller synke (symptomer på angioødem) eller overfølsomhed.
If you have stopped treatment due to hypersensitivity syndrome, it should be permanent and you should not re-start therapy with PROTELOS.
Hvis De har afbrudt behandlingen på grund af overfølsomhedssyndrom, skal afbrydelselsen være permanent, og De må ikke begynde at tage PROTELOS igen.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
OPBEVARING
HOW TO STORE PROTELOS
Brug ikke PROTELOS efter den udløbsdato, der står på æsken og brevet.
Do not use after the expiry date which is stated on the box and the sachet.
PROTELOS indeholder:
What PROTELOS contains
- Aktivt stof: strontiumranelat.
- The active substance is strontium ranelate.
Udseende og pakningsstørrelser PROTELOS fås som breve, der indeholder et gult granulat til mikstur, suspension.
What PROTELOS looks like and contents of the pack PROTELOS is available in sachets containing yellow granules for oral suspension.
Hvis De vil have yderligere oplysninger om PROTELOS, skal De henvende dig til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Denne indlægsseddel blev senest godkendt
This leaflet was last approved in{date}
De kan finde yderligere information om PROTELOS på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Hvis du ønsker yderligere oplysninger på grundlag af CHMP’ s anbefalinger, kan du læse den faglige drøftelse (der ligeledes er en del af EPAR).
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Protopic er en hvid til let gullig salve, der indeholder enten 0, 1% eller 0, 03% af det aktive stof tacrolimus.
Protopic is a white to slightly yellowish ointment that contains either 0.1% or 0.03% of the active ingredient tacrolimus.
Protopic 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 behandling eller ikke kan tåle denne.
Protopic is used for the treatment of moderate to severe atopic dermatitis (eczema, an itchy red rash of 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 Protopic desuden bruges til behandling af denne sygdom hos børn (fra 2- årsalderen), der ikke responderer på sædvanlig behandling eller ikke kan tåle denne.
The lower strength of Protopic (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.
Protopic bør ikke anvendes i længere tid.
Protopic should not be used continuously.
Hvert af de berørte områder behandles med Protopic, indtil huden er helet, hvorefter behandlingen bør ophøre.
Each affected area is treated with Protopic until the skin is clear and then treatment should be stopped.
Til børn bør Protopic kun anvendes i den lave styrke (0, 03%).
In children, only the lowest strength Protopic 0.03% should be used.
Protopic bør ikke anvendes til børn under 2 år.
Protopic should not be used in children under 2 years of age.
Hos voksne indledes behandlingen ned Protopic 0, 1% to gange dagligt og fortsætter, til huden er helet.
In adults, treatment should be started with Protopic 0.1% twice a day and treatment should be continued until the skin is clear.
Det vides endnu ikke med nøjagtighed, hvordan Protopic virker mod atopisk dermatitis.
The exact way that Protopic works in atopic dermatitis is not yet fully understood.
Tacrolimus, det aktive stof i Protopic, er et immunmodulerende stof, dvs. det har indvirkning på immunsystemet (kroppens naturlige forsvar).
Tacrolimus, the active substance in Protopic, is an immunomodulator, this means that it works on the immune system (the body ’ s natural defences).
Tacrolimus er siden midten af 1990' erne blevet anvendt til at mindske afstødningen hos transplantationspatienter (når immunsystemet angriber det transplanterede organ).
Tacrolimus has been used since the mid-1990’ s to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ).
Atopisk dermatitis er en overreaktion af hudens immunsystem, der fremkalder en betændelsestilstand (kløe, rødt udslæt, tør hud).
In atopic dermatitis, an over-reaction of the skin’ s immune system causes skin inflammation (itchiness, redness, dryness).
(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 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvordan er Protopic 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 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Protopic been studied?
Sikkerheden og virkningen af Protopic er undersøgt hos over 13 500 patienter, der blev behandlet med tacrolimus salve i kliniske undersøgelser.
The safety and effectiveness of Protopic has been studied in more than 13,500 patients treated with tacrolimus ointment in clinical trials.
De seks kliniske hovedundersøgelser omfattede 1 202 voksne (over 16 år) og 1 535 børn (i alderen 2 til 16 år), og Protopic blev enten sammenlignet med placebo (virkningsløs behandling i form af salvegrundlaget) eller med et binyrebarkhormon til lokal brug, der ofte anvendes mod eksem (hydrocortisonbutyrat til voksne, hydrocortisonacetat til børn).
The six main clinical studies involved 1,202 adults (over the age of 16) and 1,535 children (aged 2 to 16 years of age), and Protopic was compared either with placebo (a dummy treatment, the ointment base) or with a topical corticosteroid often used for eczema (hydrocortisone butyrate in adults, hydrocortisone acetate in children).
Til dette formål blev der anvendt et score- system (det såkaldte Modified Eczema Area and Severity Index), hvor alle symptomer på atopisk dermatitis tages i betragtning.
The main measure of effectiveness was the improvement in the eczema seen at the end of the study (3 or 12 weeks) using a scoring system (the modified Eczema Area and Severity Index) that looks at all the symptoms of atopic dermatitis.
800 patienter.
Another study has also looked at the use of Protopic for up to 4 years in about 800 patients.
Protopic var betydeligt mere effektivt end nogen af de to hydrocortisonpræparater til at forbedre resultaterne i score- systemet, men fremkaldte i højere grad en brændende fornemmelse på huden end hydrocortison.
Protopic 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 Protopic anvendes gentagne gange uden at miste sin virkning.
In the longer study, Protopic could be used repeatedly without losing its effectiveness.
Den fuldstændige liste over de indberettede bivirkninger for Protopic fremgår af indlægssedlen.
For the full list of all the side effects reported with Protopic, please see the Package Leaflet.
Protopic bør ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for tacrolimus eller andre af indholdsstofferne.
Protopic should not be used in people who may be hypersensitive (allergic) to tacrolimus or to any of the other ingredients.
Der er ikke påvist nogen sammenhæng med Protopic.
A link to Protopic has not been shown.
Hvorfor er Protopic blevet godkendt?
Why has Protopic been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved Protopic er større end risiciene til behandling af moderat til svær atopisk dermatitis hos voksne og børn over to år, der ikke responderer tilfredsstillende på eller ikke tåler konventionelle behandlingsformer.
The Committee for Medicinal products for Human Use (CHMP) decided that Protopic’ 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.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Protopic.
They recommended that Protopic be given marketing authorisation.
Andre oplysninger om Protopic:
Other information about Protopic:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Protopic til Astellas Pharma GmbH den 28. februar 2002.
The European Commission granted a marketing authorisation valid throughout the European Union, for Protopic to Astellas Pharma GmbH on 28 February 2002.
Denne tilladelse blev fornyet den 11- 2006.
The marketing authorisation was renewed on 11-2006.
Den Europæiske Offentlige Vurderingsrapport (EPAR) for Protopic kan ses i sin helhed her.
The full EPAR for Protopic is available here.
Dette sammendrag blev sidst opdateret i 09 2007.
This summary was last updated in 09-2007
EU/ 1/ 02/ 201/ 001 EU/ 1/ 02/ 201/ 002 EU/ 1/ 02/ 201/ 003 EU/ 1/ 02/ 201/ 004 EU/ 1/ 02/ 201/ 005 EU/ 1/ 02/ 201/ 006
EU/ 1/ 02/ 201/ 001 EU/ 1/ 02/ 201/ 002 EU/ 1/ 02/ 201/ 003 EU/ 1/ 02/ 201/ 004 EU/ 1/ 02/ 201/ 005 EU/ 1/ 02/ 201/ 006
Protopic Protopic Protopic Protopic Protopic Protopic
Protopic Protopic Protopic Protopic Protopic Protopic
0, 03% 0, 03% 0, 1% 0, 1% 0. 03% 0. 1%
0.03% 0.03% 0.1% 0.1% 0.03% 0.1%
Salve Salve Salve Salve Salve Salve
Ointment Ointment Ointment Ointment Ointment Ointment
Kutan anvendelse Kutan anvendelse Kutan anvendelse Kutan anvendelse Kutan anvendelse Kutan anvendelse
Cutaneous use Cutaneous use Cutaneous use Cutaneous use Cutaneous use Cutaneous use
Tube (laminat) Tube (laminat) Tube (laminat) Tube (laminat) Tube (laminat) Tube (laminat)
tube (laminate) tube (laminate) tube (laminate) tube (laminate) tube (laminate) tube (laminate)
30 g 60 g 30 g 60 g 10 g 10 g
30 g 60 g 30 g 60 g 10 g 10 g
1 tube 1 tube 1 tube 1 tube 1 tube 1 tube
1 tube 1 tube 1 tube 1 tube 1 tube 1 tube
Protopic 0, 03% salve
Protopic 0.03% ointment
1 g Protopic 0, 03% salve indeholder 0, 3 mg tacrolimus som tacrolimus monohydrat (0, 03%).
1 g of Protopic 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
Protopic skal initieres af læger med erfaring i diagnosticering og behandling af atopisk dermatitis.
Protopic should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Protopic salve skal påsmøres i et tyndt lag på det afficerede hudområde.
Protopic ointment should be applied as a thin layer to affected areas of the skin.
Protopic salve kan benyttes overalt på kroppen, inklusive ansigt, hals og extremiteternes flexorsider, men ikke på slimhinder.
Protopic ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes.
4. 4).
Protopic ointment should not be applied under occlusion (see section 4.4).
Et afficeret hudområde skal behandles med Protopic indtil læsionen er helet, hvorefter behandlingen bør ophøre.
Each affected region of the skin should be treated with Protopic until clearance occurs and then treatment should be discontinued.
Protopic kan benyttes til korttidsbehandling og intermitterende langtidsbehandling.
Protopic can be used for short term and intermittent long term treatment.
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 børn (2 år gamle og ældre) Behandlingen bør begynde med applikation to gange om dagen i indtil 3 uger.
Use in children (2 years of age and above) Treatment should be started twice a day for up to three weeks.
4. 4).
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) Protopic findes i 2 styrker, Protopic 0, 03% og Protopic 0, 1% salve.
Use in adults (16 years of age and above) Protopic is available in two strengths, Protopic 0.03% and Protopic 0.1% ointment.
Behandlingen bør begynde med Protopic 0, 1% to gange om dagen indtil læsionen er helet.
Treatment should be started with Protopic 0.1% twice a day and treatment should be continued until clearance of the lesion.
Hvis symptomerne vender tilbage skal man genoptage behandling med Protopic 0, 1% to gange om dagen.
If symptoms recur, twice daily treatment with Protopic 0.1% should be restarted.
Hvis den kliniske tilstand tillader det, bør man forsøge at reducere hyppigheden af applikationer eller benytte den svagere Protopic 0, 03% salve.
An attempt should be made to reduce the frequency of application or to use the lower strength Protopic 0.03% ointment if the clinical condition allows.
2 Behandling af ældre (65 år gamle og ældre) Der er ikke blevet foretaget specielle studier med ældre patienter.
2 Use in elderly (65 years of age and above) Specific studies have not been conducted in elderly patients.
Protopic må ikke anvendes til patienter med medfødt eller erhvervet immundefekt eller til patienter i behandling som forårsager immunsuppression.
Protopic should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression.
4. 1).
The effect of treatment with Protopic ointment on the developing immune system of children, especially the young, has not yet been established and this should be taken into account when prescribing to this age group (see section 4.1).
5. 3).
Exposure of the skin to sunlight should be minimised and the use of ultraviolet (UV) light from a solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use of Protopic 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 af huden med passende beklædning.
Physicians should advise patients on appropriate sun protection methods, such as minimisation of the time in the sun, use of a sunscreen product and covering of the skin with appropriate clothing.
Protopic salve må ikke anvendes på læsioner som bedømmes for at være potentielt maligne eller præmaligne.
Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant.
Protopic salve er ikke blevet afprøvet for effekt og tolerabilitet ved behandling af klinisk inficeret atopisk dermatitis.
Protopic ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Før man starter behandling med Protopic salve skal alle områder med klinisk inficeret atopisk dermatitis være helede.
Before commencing treatment with Protopic ointment, clinical infections at treatment sites should be cleared.
Behandling med Protopic kan øge risikoen for infektion med herpes virus (herpes simplex dermatitis [eczema herpeticum], herpes simplex [forkølelsessår], Kaposi' s varicelliforme eruption).
Treatment with Protopic may be associated with an increased risk of herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi’ s varicelliform eruption).
5. 1).
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).
Der er rapporteret tilfælde af maligniteter, inkl. hud og andre typer lymfom hos patienter, som bruger tacrolimus salve (se pkt 4. 8).
In patients using tacrolimus ointment, cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers have been reported (see section 4.8).
Patienter med atopisk dermatit behandlet med Protopic er ikke set at have signifikante systemiske tacrolimus niveauer.
Patients with atopic dermatitis treated with Protopic have not been found to have significant systemic tacrolimus levels.
Lymphadenopati er i sjældne tilfælde (0, 8%) set i kliniske afprøvninger.
Lymphadenopathy was uncommonly (0.8%) reported in clinical trials.
Transplanterede patienter, der får immunosuppressiv behandling (f. eks. systemisk tacrolimus) har en øget risiko for at udvikle lymfomer, hvorfor patienter, der behandles med Protopic 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 Protopic and who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
Hvis man ikke
In
3 kan finde en klar årsag til lymphadenopatien, eller i tilfælde af akut infektiøs mononucleose bør behandlingen med Protopic seponeres.
3 the absence of a clear aetiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Protopic should be considered.
Hvis der alligevel kommer salve på disse områder, skal salven tørres grundigt af og/ eller skylles af med vand.
If accidentally applied to these areas, the ointment should be thoroughly wiped off and/ or rinsed off with water.
Brug af Protopic salve under occlusion er ikke undersøgt på patienter.
The use of Protopic ointment under occlusion has not been studied in patients.
5. 2).
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).
Det kan ikke anbefales at benytte Protopic salve til patienter med genetisk epidermale barrieredefekter som Netherton' s syndrome på grund af potentialet for permanent øget systemisk absorption af tacrolimus.
The use of Protopic ointment in patients with genetic epidermal barrier defects such as Netherton’ s syndrome is not recommended due to the potential for permanently increased systemic absorption of tacrolimus.
Protopics tolerabilitet ved behandling af patienter med generaliseret erythrodermi er ikke undersøgt.
The safety of Protopic ointment has not been established in patients with generalised erythroderma.
4. 2).
Care should be exercised if applying Protopic to patients with extensive skin involvement over an extended period of time, especially in children (see section 4.2).
Der er ikke udført formelle lokale interaktionsstudier med Protopic salve.
Formal topical drug interaction studies with tacrolimus ointment have not been conducted.
Den systemiske eksponering fra lokal anvendelse af tacrolimus er lav (< 1, 0 ng/ ml) og påvirkes næppe ved samtidig brug af kendte inhibitorer of CYP3A4.
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.
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 med forsigtighed.
However, the 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 widespread and/ or erythrodermic disease should be done with caution.
Man har ikke undersøgt den mulige interaktion mellem vaccination og brug af Protopic salve.
A potential interaction between vaccination and application of Protopic ointment has not been investigated.