natgillin/translations-raw huggingface dataset:
Almindelige bivirkninger (det forekommer hos mellem 1 og 10 ud af 100 behandlede): • Ændringer i de forskellige laboratorieparametre, herunder øget leverenzymer; nyreparametre såsom kreatinin, kalium, blodsukker, fedtstoffer i blodet, kolesterol, fosfater, magnesium, kalcium og urinsyre. • Nyreproblemer med forhøjet urinstof.
Common side effects likely to affect less than 1 in 10, but more than 1 in 100 people:  Changes in different laboratory parameters, including increase in liver enzymes, renal parameters such as creatinine, potassium, blood sugar, blood lipids, cholesterol, phosphates, magnesium, calcium and uric acid  Kidney problems with increased levels of urea  Disorders of the digestive system such as constipation, indigestion, flatulence, belching, inflammation of the mouth, oesophagus, stomach, intestine, liver or pancreas and gastrointestinal bleeding  Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain
40 • Lidelser i fordøjelsessystemet såsom forstoppelse, fordøjelsesbesvær, luft i maven, bøvsen, betændelse i munden, spiserøret, maven, tarme, lever eller bugspytkirtel og blødning fra mave- tarmkanalen. • Kramper, øget muskelspændinger, rysten og muskelsvaghed, ledsmerter • Søvnløshed, svimmelhed og hovedpine, snurren og følelsesløshed, ændringer i smagssansen, appetitløshed, vægttab. • Betændelse og infektion i luftvejene og i mave- tarmkanalen, ondt i halsen, bihulebetændelse, løbende og kløende næse. • Hudkræft eller godartet vækster på huden og svampeinfektioner på huden og i skeden. • Ændringer i blodtrykket, hurtigere hjerteslag, blodkarudvidelse. • Væskeophobning i kroppen, feber, ubehag, sløvhed og svaghed. • Leverbetændelse, gulfarvning af huden og det hvide i øjnene.
42  Sleeplessness dizziness and headache, tingling or numbness, change of the sense of taste, loss of appetite, weight loss  Inflammation and infections of the respiratory and gastrointestinal tract, sore throat, inflammation of the sinuses, runny and itchy nose  Skin cancer or non cancerous growth of the skin and fungal infections of the skin and vagina  Changes in blood pressure, faster heart beat, dilation of blood vessels  Fluid retention in the body, fever, discomfort, lethargy and weakness  Inflammation of the liver, yellowing of the skin and whites of the eyes
Ikke almindelig bivirkninger (det forekommer hos mellem 1 og 10 ud af 1. 000 behandlede): • Spredning af lymfevæv, herunder kræftsvulster. • Betændelse eller infektion i hjertet og dets klapper samt i den membran der dækker hjernen og rygraden.
Uncommon side effects likely to affect less than 1 in 100 but more than 1 in 1000 people  Proliferation of the lymphatic tissue, including malignant tumours  Inflammation or infections of the heart and its valves and of the membrane that covers the brain and spinal cord
Andre bivirkninger der er rapporteret hvor hyppigheden ikke er fastlagt: • Overfølsomhedsreaktioner (allergiske reaktioner).
Other side effects that have been reported where frequency has not been established  Hypersensitivity (allergic) reactions
SÅDAN OPBEVARER DE MYCOPHENOLATE MOFETIL TEVA
HOW TO STORE MYCOPHENOLATE MOFETIL TEVA
Mycophenolate mofetil Teva indeholder
What Mycophenolate mofetil Teva contains:
- Det aktive stof er mycophenolatmofetil.
- The active substance is mycophenolate mofetil.
Hver kapsel indeholder 250 mg mycophenolatmofetil
Each capsule contains 250 mg mycophenolate
- De øvrige indholdsstoffer er:
The other ingredients are:
Pregelatineret majsstivelse Povidon K- 30 Croscarmellosenatrium Magnesiumstearat
Pregelatinised maize starch Povidone K-30 Croscarmellose sodium Magnesium stearate
Kapselskal:
Capsule shells:
Indigo carmin (E132) Titandioxid (E 171)
Indigo carmine (E132) Titanium dioxide (E171) Gelatin Body:
Sort jernoxid (E172), propylenglycol og kaliumhydroxid
43 Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide
Mycophenolate mofetil Tevas udseende og pakningsstørrelse Kapsler, hårde:
What Mycophenolate mofetil Teva looks like and contents of the pack
Krop: er uigennemsigtig karamelfarvet printet ” 250 ” aksialt med sort blæk.
Body: caramel opaque, printed ‘ 250’ axially in black ink.
Hoved: er uigennemsigtig lyseblå printet ” M ” aksialt med sort blæk.
Cap: light blue opaque printed ‘ M’ axially in black ink.
Mycophenolate mofetil Teva 250 mg kapsler, hårde fås i PVC/ PVdC- aluminium blister i Pakkestørrelser på 100 eller 300 kapsler pr. karton.
Mycophenolate mofetil Teva 250 mg hard capsules are available in PVC/ PVdC -aluminium blisters in pack sizes of 100 or 300 capsules per carton.
Indehaver af markedsførringstilladelse Teva Pharma B. V.
Marketing Authorisation Holder Teva Pharma B. V.
Fremstiller Teva Pharmaceuticals Works Private Limited Company Pallagi út 13 Debrecen H- 4042 Ungarn
Manufacturers Teva Pharmaceutical Works Private Limited Company Pallagi út 13 Debrecen H-4042 Hungary
Teva Pharmaceuticals Works Private Limited Company H- 2100 Gödöllő Táncsics Mihály út 82 Ungarn
TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöllő Táncsics Mihály út 82 Hungary
TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG England
TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
Pharmachemie B. V Swensweg 5 2031 GA Haarlem Holland
Swensweg 5 2031 GA Haarlem The Netherlands
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) hhtp: / /www. emea. europa. eu
43 INDLÆGSSEDDEL:
44 PACKAGE LEAFLET:
Mycophenolate mofetil Teva 500 filmovertrukne tabletter Mycophenolatmofetil
Mycophenolate mofetil Teva 500mg film-coated tablets Mycophenolate mofetil
- Hvis du har eller nogensinde har haft problemer med dit fordøjelsessystem, feks. mavesår.
- if you have or ever have had any problems with your digestive system, e. g. stomach ulcers
Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
Taking other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
44 Hvis du kan svare ja til nogen af de følgende spørgsmål, skal du tale med din læge, før du begynder at tage Mycophenolate mofetil Teva:
45 If you answer yes to any of the following questions talk to your doctor before you start to take Mycophenolate mofetil Teva:
nedsætter immunforsvaret (som undertiden gives til patienter efter en transplantationsoperation), colestyramin (som bruges til behandling af patienter med for højt kolesteroltal), rifampicin (antibiotika), mavesårsmedicin, phosphatbindere (bruges til patienter med kronisk nyresvigt for at reducere absorptionen af phosphat) eller anden medicin (inklusive håndkøbsmedicin), som din læge ikke er bekendt med?
are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high blood cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic kidney failure to reduce the absorption of phosphate), or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
Mycophenolate mofetil Teva kan måske forårsage spontane aborter eller skade dit ufødte barn, herunder give problemer med udviklingen af ørerne.
Your doctor should advise you about using contraception before taking Mycophenolate mofetil Teva, whilst taking Mycophenolate mofetil Teva, and for 6 weeks after you have stopped taking Mycophenolate mofetil Teva. Mycophenolate mofetil Teva may cause spontaneous abortions or damage, including problems with development of the ears, to your unborn baby.
Det er ikke påvist, at Mycophenolate mofetil Teva påvirker evnen til at føre bil eller betjene maskiner
Driving and using machines Mycophenolate mofetil Teva has not been shown to impair your ability to drive or operate machines.
45 Voksne:
46 Adults:
Den første dosis Mycophenolate mofetil Teva til indtagelse gennem munden gives tidligst 4 dage efter transplantationen, og når du er i stand til at indtage medicin gennem munden.
The first dose of oral Mycophenolate mofetil Teva will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.
Den anbefalede daglige dosis er 6 tabletter (3 g aktivt stof) indtaget som to separate doser.
The recommended daily dose is 6 tablets (3 g of the active ingredient) taken as 2 separate doses.
Anvendelsesmåde og indgivelsesvej Synk tabletterne hele med et glas vand.
Method and route of administration Swallow your tablets whole with a glass of water.
Det er vigtigt ikke at indtage for mange tabletter.
If you take more Mycophenolate mofetil Teva than you should It is important not to take too many tablets.
Almindelige bivirkninger (det forekommer hos mellem 1 og 10 ud af 100 behandlede): • Ændringer i de forskellige laboratorieparametre, herunder øget leverenzymer; nyreparametre såsom kreatinin, kalium, blodsukker, fedtstoffer i blodet, kolesterol, fosfater, magnesium, kalcium og urinsyre. • Nyreproblemer med forhøjet urinstof. • Lidelser i fordøjelsessystemet såsom forstoppelse, fordøjelsesbesvær, luft i maven, betændelse i munden, spiserøret, maven, tarme, lever eller bugspytkirtel og blødning fra mave - tarmkanalen. • Kramper, øget muskelspændinger, rysten og muskelsvaghed, ledsmerter. • Søvnløshed, svimmelhed og hovedpine, snurren og følelsesløshed, ændringer i smagssansen, appetitløshed, vægttab.
Common side effects likely to affect less than 1 in 10, but more than 1 in 100 people:  Changes in different laboratory parameters, including increase in liver enzymes, renal parameters such as creatinine, potassium, blood sugar, blood lipids, cholesterol, phosphates, magnesium, calcium and uric acid  Kidney problems with increased levels of urea  Disorders of the digestive system such as constipation, indigestion, flatulence, belching, inflammation of the mouth, oesophagus, stomach, intestine, liver or pancreas and gastrointestinal bleeding  Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain  Sleeplessness dizziness and headache, tingling or numbness, change of the sense of taste, loss of appetite, weight loss 47  Inflammation and infections of the respiratory and gastrointestinal tract, sore throat, inflammation of the sinuses, runny and itchy nose  Skin cancer or non cancerous growth of the skin and fungal infections of the skin and vagina  Changes in blood pressure, faster heart beat, dilation of blood vessels  Fluid retention in the body, fever, discomfort, lethargy and weakness  Inflammation of the liver, yellowing of the skin and whites of the eyes
SÅDAN OPBEVARER DU MYCOPHENOLATE MOFETIL TEVA
HOW TO STORE MYCOPHENOLATE MOFETIL TEVA
Mycophenolate mofetil Teva indeholder Det aktive stof er mycophenolatmofetil.
The active substance is mycophenolate mofetil.
Mikrokrystallinsk cellulose Povidon K- 30 Magnesiumstearat Croscarmellosenatrium
Microcrystalline cellulose Povidone K-30 Magnesium stearate Croscarmellose sodium
Hypromellose (HPMC 2910) Titandioxid (E 171) Macrogol (PEG 400) Talcum Indigocarmin (E132) Sort jernoxid (E172) Rød jernoxid (E172)
Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
47 Mycophenolate mofetil Tevas udseende og pakningstørrelse Filmovertrukne tabletter:
48 What Mycophenolate mofetil Teva looks like and contents of the pack
Mycophenolate mofetil Teva 500 mg filmovertrukt tabletter fås i PVC/ PVdC- aluminium blistre i Pakningstørrelser på 50 og 150 tabletter pr. karton.
Mycophenolate mofetil Teva 500 mg film-coated tablets are available in PVC/ PVdC -aluminium blisters in pack sizes of 50 or 150 tablets per carton.
Computerweg 10 3542 DR Utrecht Holland
Computerweg 10, 3542 DR Utrecht The Netherlands
Fremstiller Teva Pharmaceuticals Works Private Limited Company Pallagi út 13 Debrecen H- 4042 Ungarn
Debrecen H-4042 Hungary
Teva Pharmaceuticals Works Private Limited Company H- 2100 Gödöllő Táncsics Mihály út 82 Ungarn
Teva Pharmaceuticals Works Private Limited Company H-2100 Gödöllő Táncsics Mihály ut 82 Hungary
TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG England
Teva UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG, UK
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.
48
49
Myfenax er et generisk lægemiddel.
Myfenax is a ‘ generic medicine’.
Det betyder, at Myfenax er identisk med et referencelægemiddel, der allerede er tilladt i EU, nemlig CellCept.
This means that Myfenax is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called CellCept.
Yderligere oplysninger om generiske lægemidler med spørgsmål og svar findes her.
For more information on generic medicines, see the question-and-answer document here.
Myfenax anvendes til at forhindre kroppen i at afstøde en transplanteret nyre, hjerte eller lever.
Myfenax is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Det anvendes sammen med ciclosporin og binyrebarkhormoner, der er andre lægemidler til forebyggelse af organafstødning.
It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Behandling med Myfenax bør iværksættes og fortsættes af en læge med speciale i transplantationer.
Myfenax treatment should be initiated and maintained by a qualified transplant specialist.
Det er organtypen og patientens alder og størrelse, der afgør, hvordan Myfenax skal gives, og i hvilken dosis.
The way that Myfenax should be given and the dose depend on the type of organ transplant and the patient ’ s age and size.
Den anbefalede dosis til voksne, der har fået transplanteret en nyre, er 1, 0 g to gange dagligt med start inden for 72 timer efter transplantationen.
For kidney transplants, the recommended dose in adults is 1.0 g twice a day starting within 72 hours after the transplant.
Til børn mellem 2 og 18 år beregnes Myfenax- dosen på grundlag af barnets højde og vægt.
In children aged between two and 18 years, the dose of Myfenax is calculated depending on height and weight.
Den anbefalede dosis til voksne, der har fået transplanteret et hjerte, er 1, 5 g to gange dagligt med start senest fem dage efter transplantationen.
For heart transplants, the recommended adult dose is 1.5 g twice a day, starting within five days following the transplant.
Ved levertransplantation hos voksne skal Myfenax gives som infusion (drop i en vene) i de første fire dage efter transplantationen, og patienten skiftes over til 1, 5 g Myfenax to gange dagligt, så snart han/ hun kan tåle det.
For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to 1.5 g Myfenax twice a day as soon as it can be tolerated.
Det anbefales ikke at anvende Myfenax til børn efter hjerte - eller levertransplantation på grund af manglende oplysninger om lægemidlets virkning hos denne gruppe.
Myfenax is not recommended for use in children after heart or liver transplants because of a lack of information on its effects in this group.
Det kan være nødvendigt at tilpasse dosis hos patienter med lever - eller nyresygdom.
The dose may need to be adjusted in patients with liver or kidney disease.
Det omdannes i kroppen til mycophenolsyre, der blokerer enzymet inosinmonofosfatdehydrogenase.
This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Dette enzym er 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
By 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(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 2008 Reproduction and/ or distribution of this document is authorised for non- commercial or commercial purposes, provided the EMEA is acknowledged vigtigt for dannelsen af dna i cellerne, især i lymfocytterne, der er en type hvide blodlegemer, som deltager i afstødningen af transplanterede organer.
(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 2008 Reproduction and/ or distribution of this document is authorised for non-commercial or commercial purposes, provided the EMEA is acknowledged preventing the production of new DNA, Myfenax reduces the rate at which the lymphocytes multiply.
Dette gør dem mindre effektive til at genkende og angribe det transplanterede organ, og risikoen for organafstødning mindskes derfor.
This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Da Myfenax er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet (dvs. at de producerer samme mængder af det aktive stof i kroppen).
Because Myfenax is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (they produce the same levels of the active substance in the body).
Hvilken fordel og risiko er der forbundet med Myfenax?
What are the benefit and risk of Myfenax?
Da Myfenax er et generisk lægemiddel, der er bioækvivalent med referencelægemidlet, anses benefit/ risk- forholdet for at være det samme som for referencelægemidlet.
Because Myfenax is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Myfenax i overensstemmelse med EU' s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med CellCept.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Myfenax has been shown to have comparable quality and to be bioequivalent to Cellcept.
Det var derfor CHMP' s opfattelse, at fordelene opvejer risiciene som for CellCept.
Therefore, the CHMP’ s view was that, as for CellCept, the benefit outweighs the identified risk.
Andre oplysninger om Myfenax:
Other information about Myfenax:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Myfenax til Teva Pharma B. V. den 21. februar 2008.
The European Commission granted a marketing authorisation valid throughout the EU for Myfenax to Teva Pharma B. V. on 21 February 2008.
Den fuldstændige EPAR for Myfenax findes her.
The full EPAR for Myfenax can be found here.
Den fuldstændige EPAR for referencelægemidlet findes også på EMEA' s websted.
The full EPAR for the reference medicine can also be found on the EMEA’ s website.
EU- nummer EU/ 1/ 07/ 438/ 001 EU/ 1/ 07/ 438/ 002 EU/ 1/ 07/ 438/ 003 EU/ 1/ 07/ 438/ 004
EU/ 1/ 07/ 438/ 001 EU/ 1/ 07/ 438/ 002 EU/ 1/ 07/ 438/ 003 EU/ 1/ 07/ 438/ 004
Særnavn Myfenax Myfenax Myfenax Myfenax
Myfenax Myfenax Myfenax Myfenax
Kapselens ” hoved ” er uigennemsigtig lyseblå printet ” M ” aksialt med sort blæk.
Hard capsule (capsule) The capsule: body is caramel opaque, printed with ‘ 250’ axially in black ink The capsule cap is light blue opaque printed ‘ M’ axially in black ink.
Myfenax er, i kombination med ciclosporin og kortikosteroider, indiceret til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre -, hjerte -, eller levertransplantater.
Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Oralt Myfenax bør gives indenfor 72 timer efter transplantation.
Adults: oral Myfenax should be initiated within 72 hours following transplantation.
Myfenax kapsler må kun ordineres til patienter med en legemsoverflade på mindst 1, 25 m2.
Myfenax capsules should only be prescribed to patients with a body surface area of at least 1.25 m2.
Til patienter med en legemsoverflade på 1, 25- 1, 5 m2 kan der ordineres Myfenax - kapsler i en dosis på 750 mg to gange daglig (daglig dosis:
Patients with a body surface are of 1.25 to 1.5 m2 may be prescribed Myfenax capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Til patienter med en legemsoverflade > 1, 5 m2 kan der ordineres Myfenax- kapsler i en dosis på 1 g to gange daglig (daglig dosis:
Patients with a body surface area greater than 1.5 m2 may be prescribed Myfenax capsules at a dose of 1 g twice daily (2 g daily dose).
De er ikke tilstrækkelige til af komme med dosisrekommendationer, og det anbefales derfor ikke at anvende Myfenax til denne aldersgruppe.
These are insufficient to make dosage recommendations and therefore use in this age group is not recommended.
Oralt Myfenax bør gives indenfor 5 døgn efter transplantation.
Adults: oral Myfenax should be initiated within 5 days following transplantation.
Der er ingen data vedrørende hjertetransplantationer hos børn, bør ikke anvendes til denne gruppe af patienter, før end yderligere data er tilgængelig til at understøtte dette.
2 Children and adolescents: no data are available for paediatric cardiac transplant patients, therefore use in this patients group is not recommended until further data to support this is available.
Voksne: mycophenolatmofetil skal gives intravenøst i de 4 første dage efter en levertransplantation og herefter skal oral administration påbegyndes så snart det tåles.
Adults: intravenous mycophenolate should be administered for the first 4 days following hepatic transplant, with oral Myfenax initiated as soon after this as it can be tolerated.
Den anbefalede orale Myfenax dosis til levertransplantationspatienter er 1, 5 g to gange daglig (en døgndosis på 3 g).
The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Anvendelse til ældre (≥ 65 år)
Use in elderly (≥ 65 years)
Hos nyretransplanterede patienter med svær, kronisk nyreinsufficiens (glomerulær filtration < 25 ml min- 1 1, 73 m- 2), bortset fra den umiddelbare post- transplantionsperiode, bør doser på mere end 1 g administreret to gange dagligt undgås.
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 ml min-1 1.73 m-2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
Nyretransplantatafstødning medfører ingen ændringer af MPA’ s farmakokinetik; dosisreduktion eller afbrydelse af Myfenax er ikke nødvendig.
Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of Myfenax is not required.
Der er ikke grundlag for justering af Myfenax- dosis efter afstødning af hjertetransplantat.
There is no basis for Myfenax dose adjustment following cardiac transplant rejection.
Overfølsomhed over for det aktive stof, over for mycophenolatsyre eller over for et eller flere af hjælpestofferne.
Hypersensitivity reactions to the active substance, to mycophenolic acid or any of the excipients..
4. 6).
Myfenax is contraindicated in women who are breast-feeding (see section 4.6).
4. 8).
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including Myfenax, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8).
For at minimere risikoen for hudkræft må det generelt tilrådes, at udsættelse for sollys og ultraviolet (UV) lys begrænses ved, at der bæres beskyttende beklædning, og ved at der anvendes en solblokker med en høj beskyttelsesfaktor.
As general advice to minimise the risk for skin cancer, exposure to sunlight and ultra violet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.