natgillin/translations-raw huggingface dataset:
Protopic is available in two strengths (Protopic 0.03% and Protopic 0.1% ointment).
Protopic je na voljo v dveh jakostih (Protopic 0, 03% in Protopic 0, 1% mazilo).
61, D-81673 München, Germany.
61, D- 81673 München, Nemčija.
Ltd., Killorglin, County Kerry, Ireland.
Ltd., Killorglin, County Kerry, Irska.
Protopic 0.1% 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.
Protopic 0, 1% mazilo se uporablja za zdravljenje zmernega do hudega atopičnega dermatitisa (ekcema) pri odraslih, ki se na konvencionalne načine zdravljenja, kot so lokalni kortikosteroidi, ne odzovejo ustrezno ali jih ne prenašajo.
For live
Z živimi atenuiranimi cepivi (npr.
42 attenuated vaccinations (e. g. measles, mumps, rubella or oral polio) the waiting time is 28 days, for inactivated vaccines (e. g. tetanus, diphtheria, pertussis or influenza) 14 days.
42 proti ošpicam, mumpsu, rdečkam in peroralnim proti poliu) je treba počakati 28 dni, z inaktiviranimi cepivi (npr. proti tetanusu, davici, oslovskemu kašlju ali gripi) pa 14 dni.
Two strengths of Protopic (Protopic 0.03% and Protopic 0.1% ointment) are available for adult patients (16 years of age and older).
Za odrasle bolnike (bolnike, stare vsaj 16 let) sta na voljo dve jakosti Protopica (Protopic 0, 03% in Protopic 0, 1% mazilo).
43 Treat each affected region of your skin until the eczema has gone away.
43 Prizadete predele kože zdravite, dokler ekcem ne izgine.
One gram of Protopic 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
En gram mazila Protopic 0, 1% vsebuje 1, 0 mg takrolimusa (v obliki takrolimus monohidrata).
Protopic is a dermatological medicinal product that contains the calcineurin inhibitor tacrolimus at a 0.1% and 0.03% concentration.
Protopic je dermatološko zdravilo, ki vsebuje takrolimus, zaviralec kalcineurina, v koncentraciji 0, 1% in 0, 03%.
Protopic 0.1% is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults who are not adequately responsive to or are intolerant of conventional therapies and Protopic 0.03% is indicated for the treatment of moderate to severe AD in adults or children (2 years of age and above) who failed to respond adequately to conventional therapies.
Protopic 0, 1% je namenjen zdravljenju zmernega do hudega atopičnega dermatitisa (AD) pri odraslih, ki se na konvencionalne terapije ne odzovejo ustrezno ali jih ne prenesejo, Protopic 0, 03% pa je namenjen zdravljenju zmernega do hudega atopičnega dermatitisa (AD) pri odraslih ali otrocih (starih 2 leti ali več), ki se na konvencionalne terapije ne odzovejo ustrezno.
On 21 April 2005 the European Commission in view of the potential risk of malignancies requested the Opinion of the CHMP on the benefit/ risk profile of Protopic.
Dne 21. aprila 2005 je Evropska komisija zaprosila Odbor za zdravila za uporabo v humani medicini (CHMP) za mnenje o razmerju med koristmi in tveganji za zdravilo Protopic z vidika potencialnega tveganja za maligna obolenja.
Following this request, the CHMP reviewed the available data on this safety issue, including post-marketing reports, data from non- clinical studies, clinical trials and epidemiological studies.
Na podlagi te zahteve je CHMP pregledal razpoložljive podatke v zvezi s tem vidikom varnosti, vključno s postmarketinškimi poročili, podatki iz nekliničnih raziskav, kliničnih raziskav in epidemioloških raziskav.
Case reports of malignancies (including skin cancer, cutaneous T-Cell lymphoma (CTCL), Non- Hodking lymphoma (NHL) and systemic malignancies) have been received during the clinical development and post-marketing experience in association with the use of Protopic.
V okviru kliničnega razvoja in postmarketinških izkušenj, povezanih z uporabo zdravila Protopic, so poročali o posameznih primerih malignih obolenj (vključujočih kožni rak, kožni limfom celic T (CTCL, Cutaneous T- Cell Lymphoma), ne- Hodgkinov limfom (NHL) in sistemska maligna obolenja).
The mode of action of tacrolimus is stated to be by inhibition of calcium dependent signal transduction pathways in T cells which results in prevention of transcription and synthesis of IL-2, IL- 3, IL-4, IL-5 and other cytokines.
Način delovanja takrolimusa naj bi bil po navedbah zaviranje od kalcija odvisnih poti prevajanja v celicah T, kar prepreči transkripcijo in sintezo IL- 2, IL- 3, IL- 4, IL- 5 ter drugih citokinov.
In order to reduce the likelihood of mis-diagnosis and in order to better ensure the appropriate use of the medicinal product, the CHMP emphasised that the product information should reflect that the initial diagnosis and initial prescription should be undertaken by physicians with experience in the treatment of AD.
Da bi zmanjšali verjetnost napačno postavljenih diagnoz in v večji meri zagotovili ustrezno uporabo zdravila, je CHMP poudaril, da morajo informacije o zdravilu odražati zahtevo po tem, da začetno diagnozo postavi in zdravilo uvede zdravnik z izkušnjami pri zdravljenju atopičnega dermatitisa.
Additionally, the CHMP concluded that Protopic should not be used in immunocompromised adults or children and that Protopic should not be applied to lesions that are considered to be potentially malignant or pre-malignant and that lymphadenopathy present at initiation of therapy should be investigated and kept under review.
Poleg tega je CHMP sklenil, da se zdravila Protopic ne sme uporabljati pri odraslih ali otrocih z oslabljenim imunskim sistemom ter da se ga ne sme nanašati na lezije, ki so ocenjene kot potencialno maligne ali predmaligne, in da je potrebno limfoadenopatije, prisotne ob začetku zdravljenja, raziskati in nadzorovati.
1 The CHMP also expressed concerns about the degree of use of Protopic in children under the age of 2 (not approved) when the immune system is still developing.
1 CHMP je tudi izrazil zaskrbljenost v zvezi s stopnjo uporabe zdravila Protopic pri otrocih, starih manj kot dve leti (uporaba ni odobrena), pri katerih se imunski sistem šele razvija.
The CHMP endorsed the ongoing registry study presented by the Marketing Authorisation Holder - APPLES study (paediatric registry).
CHMP je odobril potekajočo pripravo registrske študije, ki jo je predstavil imetnik dovoljenja za promet z zdravilom – raziskava APPLES (pediatrični register).
- The Committee considered the procedure under Article 20 of Regulation (EC) No 726/ 2004 for
726/ 2004 za zdravilo
Protopic
Protopic.
- The Committee acknowledged that cases of malignancy (including skin cancer and lymphoma)
- je Odbor vzel na znanje, da so pri bolnikih, zdravljenih z zdravilom Protopic, poročali o
have been reported in patients treated with Protopic.
primerih malignih obolenj (vključujočih kožni rak in limfom).
In view of the available data (including pre-clinical, clinical and epidemiological) the CHMP concluded that a potential association with the use of Protopic cannot be ruled out and therefore further data are needed to ensure an acceptable long-term safety profile.
CHMP je na podlagi razpoložljivih podatkov (vključujočih predklinične, klinične in epidemiološke podatke) zaključil, da potencialne povezave z uporabo zdravila Protopic ni mogoče izključiti in da je zaradi tega potrebno zbrati dodatne podatke, ki bi zagotovili sprejemljiv dolgoročni varnostni profil.
- The Committee, as a consequence, concluded that the following information should be included
- je Odbor posledično sklenil, da je potrebno v Povzetek glavnih značilnosti zdravila in ustrezne
in the Summary of Product Characteristics and relevant sections of the Package Leaflet of Protopic:
razdelke Navodil za uporabo za zdravilo Protopic vključiti naslednje informacije:
The treatment with Protopic should only be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Zdravljenje z zdravilom Protopic sme uvesti le zdravnik, ki ima izkušnje z diagnostiko in z zdravljenjem atopičnega dermatititsa.
The treatment should be intermittent and not continuous.
Zdravljenje mora potekati z vmesnimi prekinitvami in ne kontinuirano.
A statement to highlight that tacrolimus should not be applied to lesions, which are considered to be potentially malignant or pre-malignant.
Opozorilo, ki bo poudarilo, da takrolimusa ni dovoljeno nanašati na lezije, ki so ocenjene kot potencialno maligne ali predmaligne.
Protopic should not be used in immunocompromised adults or children.
Zdravila Protopic se ne sme uporabljati pri odraslih ali otrocih z oslabljenim imunskim sistemom.
A warning to advise that any lymphadenopathy present prior to initiation of therapy should be investigated and kept under assessment.
Opozorilni nasvet, da je potrebno raziskati in nadzorovati limfoadenopatije, prisotne pred začetkom zdravljenja.
A statement that Protopic should not be used in children under 2 years.
Navedbo, da zdravila Protopic ni dovoljeno uporabljati pri otrocih, starih manj kot 2 leti.
A statement reflecting the cases of malignancies reported in the post-marketing
Navedbo, ki odraža primere malignih obolenj, o katerih so poročali v postmarketinškem obdobju.
ed This document is a summary of the European Public Assessment Report (EPAR).
et Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila (EPAR).
is the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
m je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene raziskave, na
or If you need more information about your medical condition or your treatment, read the Package
o podlagi česar je oblikoval priporočila glede uporabe zdravila.
th Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
pr Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodila za uporabo (ki so prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
au of the EPAR).
za prav tako del EPAR).
er What is Protopy?
a nj Kaj je zdravilo Protopy?
Protopy is a white to slightly yellowish ointment that contains either 0.1% or 0.03% of the active ng ingredient tacrolimus. lo
Zdravilo Protopy je belo do rahlo rumenkasto mazilo, ki vsebuje bodisi 0, 1% ali 0, 03% zdravilne lje učinkovine takrolimus. vo
Protopy is used for the treatment of moderate to severe atopic dermatitis (eczema, an itchy red rash of no
Zdravilo Protopy se uporablja za zdravljenje zmernega do hudega atopičnega dermatitisa (ekcema, do
the skin- atopic means that is linked to an allergy) in adults who do not respond well or do not tolerate usual treatments.
srbečega kožnega izpuščaja s pordelostjo; atopičen pomeni, da je povezan z alergijo) pri odraslih, ki se na običajne terapije ne odzovejo ustrezno ali jih ne prenesejo.
The lower strength of Protopy (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. ct
Oblika zdravila Protopy z manjšo jakostjo (0, 03%) se lahko uporablja tudi za zdravljenje tega stanja pri otrocih (starih 2 leti ali več), ki ā
The medicine can only be obtained with a prescription. du
se neustrezno odzivajo na običajne terapije ali pa jih ne prenašajo. ve
How is Protopy used?
Kako se zdravilo Protopy uporablja? a
Protopy should be prescribed by a doctor with experience in the diagnosis and treatment of atopic ro
Zdravilo Protopy lahko predpišejo le zdravniki, ki imajo izkušnje s postavljanjem diagnoze in m
dermatitis. lp
Zdravilo Protopy ni za stalno uporabo.
Protopy should not be used continuously.
Vsak prizadeti predel kože je treba z zdravilom Protopy zdraviti, dokler spremembe ne izginejo.
The ointment should be applied as a thin layer to affected areas of the skin.
Potem je treba zdravljenje prekiniti.
Each affected area is treated with Protopy until the skin is clear and then treatment a
Izboljšanje se praviloma pojavi v enem tednu po začetku lo
should be stopped.
zdravljenja.
Generally, improvement is seen within one week of starting treatment, and if there is no improvement after 2 weeks, the doctor needs to look at more treatment options. in
Če po 2 tednih zdravljenja ni znakov izboljšanja, mora zdravnik pretehtati druge možnosti vi
In children, only the lowest strength Protopy 0.03% should be used.
Pri otrocih je treba uporabiti obliko zdravila Protopy z manjšo jakostjo (0, 03%).
Treatment should be started as ic
Zdravljenje je treba ra
twice a day for up to three weeks.
začeti z uporabo dvakrat dnevno do tri tedne.
Afterwards, application should be reduced to once a day until the skin is clear.
dnevno in zdravilo uporabljati, dokler spremembe ne izginejo.
Protopy should not be used in children under 2 years of age. ed
Zdravila Protopy se ne sme uporabljati za otroke mlajše od 2 let.
In adults, treatment should be started with Protopy 0.1% twice a day and treatment should be continued until the skin is clear.
Pri odraslih je treba zdravljenje začeti z zdravilom Protopy 0, 1% dvakrat dnevno in ga nadaljevati, dokler spremembe ne izginejo.
If possible, patients should use less frequent applications, or the lower M
Ko se stanje izboljša, naj bolniki uporabljajo zdravilo redkeje ali v obliki z manjšo jakostjo, če je možno.
Tacrolimus, the active substance in Protopy, is an immunomodulator, this means that it works on the immune system (the body ’ s natural defences).
Takrolimus, zdravilna učinkovina zdravila Protopy, je imunomodulator, kar pomeni, da deluje na imunski sistem (naravne obrambne mehanizme telesa).
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Protopy been studied?
Takrolimus umiri imunski sistem, kar olajša vnetje kože in srbečico.
The safety and effectiveness of Protopy has been studied in more than 13,500 patients treated with tacrolimus ointment in clinical trials.
Varnost in učinkovitost zdravila Protopy so preučili pri več kot 13. 500 bolnikih, ki so bili v kliničnih preskušanjih zdravljeni z mazilom, ki je vsebovalo takrolimus.
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 Protopy 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).
Zdravilo Protopy so primerjali bodisi s placebom (zdravilom brez zdravilne učinkovine, osnovo mazila) bodisi s topičnim kortikosteroidom, ki se pogosto uporablja za ekceme (hidrokortizon butirat pri odraslih, hidrokortizon acetat pri otrocih).
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.
Glavno merilo učinkovitosti je bilo izboljšanje ekcema na koncu raziskave (3 ali 12 tednov) na podlagi sistema točkovanja, imenovanega modificirani indeks površine in resnosti ekcema (Modified Eczema Area and Severity Index), ki zajema vse simptome atopičnega
What benefit has Protopy shown during the studies?
m Kakšne koristi je zdravilo Protopy izkazalo med raziskavami?
ed Protopy 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.
pr spodbujanju napredka po indeksu površine in resnosti ekcema, čeprav je v več primerih povzročil pekoč občutek kot hidrokortizon.
In the longer study, Protopy could be used repeatedly without losing its
V daljši raziskavi so lahko zdravilo Protopy uporabili v ponovitvah
is effectiveness.
za brez zmanjšanja učinkovitosti.
or What is the risk associated with Protopy?
Kakšna tveganja so povezana z zdravilom Protopy?
th The most common side effects (seen in more than 1 patient in 10) are burning sensation and itching at the application site.
a Najpogostejša neželena učinka (opažena pri več kot 1 bolniku od 10) sta bila pekoč občutek in
au Package Leaflet.
nj srbečica ne mestu uporabe.
Protopy should not be used in people who may be hypersensitive (allergic) to tacrolimus or to any of
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Protopy, najdete v Navodilih za uporabo. lje Zdravila Protopy ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) takrolimus ali katerokoli drugo sestavino zdravila. vo
Doctors must be aware that a very small number of patients using the medicine have developed cancer ng (skin cancer, lymphoma).
Zelo majhno število bolnikov je imelo raka (kožnega raka, limfom) v času uporabe zdravila.
A link to Protopy has not been shown.
Povezava z zdravilom Protopy ni bila dokazana, vendar se morajo zdravniki tega zavedati in zagotoviti, da se do
However, doctors must ensure that the medicine is used appropriately. lo
zdravilo uporablja pravilno ter da bolnika spremljajo med zdravljenjem. ā
Why has Protopy been approved? no
Zakaj je bilo zdravilo Protopy odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that Protopy’ 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. ct
pri zdravljenju zmernega do hudega atopičnega dermatitisa pri odraslih in otrocih, starih 2 leti ali več, ki se neustrezno odzivajo na običajne terapije ali pa jih ne prenašajo, večji od z njim povezanih a
They recommended that Protopy be given marketing authorisation. du
Odbor je za zdravilo Protopy priporočil odobritev dovoljenja za promet z zdravilom. m
Other information about Protopy:
Druge informacije o zdravilu Protopy: ni
for Protopy to Astellas Pharma GmbH on 28 February 2002.
Evropska komisija je dovoljenje za promet z zdravilom Protopy, veljavno po vsej Evropski uniji, odobrila družbi Astellas Pharma GmbH dne 28. februarja 2002.
The marketing authorisation was renewed on 11-2006.
Dovoljenje za promet z zdravilom je lo
a
bilo podaljšano dne 11- 2006. vi
The full EPAR for Protopy is available here. in ic ed
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Protopy je na voljo tukaj. ra Zd
This summary was last updated in 09-2007 M
Ta povzetek je bil nazadnje posodobljen 09- 2007.
is EU/ 1/ 02/ 202/ 001
et Številka EU EU/ 1/ 02/ 202/ 001
Protopy
Zaščiteno ime Protopy
0.03%
Jakost 0, 03%
Ointment
Farmacevtska oblika Mazilo
Cutaneous use
Pot uporabe Za dermalno uporabo
Tube (laminate)
Ovojnina Laminatna tuba
30 g
Vsebina 30 g
1 tube
Velikost pakiranja 1 tuba
Tube (laminate)
Laminatna tuba
th EU/ 1/ 02/ 202/ 003
o pr EU/ 1/ 02/ 202/ 003 EU/ 1/ 02/ 202/ 004
0.1%
0, 1% 0, 1%
Ointment
Mazilo Mazilo
Cutaneous use
Za dermalno uporabo Za dermalno uporabo
Tube (laminate)
Laminatna tuba Laminatna tuba
30 g
30 g 60 g
au EU/ 1/ 02/ 202/ 004 EU/ 1/ 02/ 202/ 005
za EU/ 1/ 02/ 202/ 005 EU/ 1/ 02/ 202/ 006
Ointment Ointment
Mazilo Mazilo
Cutaneous use Cutaneous use
Za dermalno uporabo Za dermalno uporabo
Tube (laminate) Tube (laminate)
Laminatna tuba Laminatna tuba
1 tube 1 tube
1 tuba 1 tuba
ng lo o tn uc od pr al in ic ed M
a nj lje vo do ā ve a m ni lo vi ra Zd
ed is or th au er ANNEX I ng SUMMARY OF PRODUCT CHARACTERISTICS lo no ct du ro lp a in ic ed M
et m o pr za a nj DODATEK I lje POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA vo do ā ve a m ni lo vi ra Zd
Protopy 0.03% ointment
Protopy 0, 03% mazilo
1 g of Protopy 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
1 g mazila Protopy 0, 03% vsebuje 0, 3 mg takrolimusa v obliki takrolimus monohidrata (0, 03%).
ed 3.
et 3.
is Ointment
m Mazilo
or A white to slightly yellowish ointment.
o pr Belo do rahlo rumenkasto mazilo.
er Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or ng are intolerant of conventional therapies such as topical corticosteroids.
nj Zdravljenje zmernega do hudega atopičnega dermatitisa pri odraslih, ki se na konvencionalne terapije, lje kot so lokalni kortikosteroidi, ne odzovejo ustrezno ali jih ne prenesejo.
Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to lo conventional therapies such as topical corticosteroids. no
Zdravljenje zmernega do hudega atopičnega dermatitisa pri otrocih (starih 2 leti ali več), ki se na konvencionalne terapije, kot so lokalni vo kortikosteroidi, ne odzovejo ustrezno.
4.2 Posology and method of administration
4. 2 Odmerjanje in način uporabe do
Protopy should be initiated by physicians with experience in the diagnosis and treatment of atopic ct
Zdravljenje s Protopyom morajo uvesti zdravniki, ki imajo izkušnje z diagnosticiranjem in zdravljenjem ā
dermatitis. du
atopičnega dermatitisa. ve
Treatment should be intermittent and not continuous. ro
Zdravljenje mora biti intermitentno, ne neprekinjeno.
Protopy ointment should be applied as a thin layer to affected areas of the skin.
Protopy mazilo se lahko uporabi a
Protopy ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. lp
Protopy mazilo se ne sme m
Protopy ointment should not be applied under occlusion (see section 4.4). a
uporabiti pod okluzijo (glejte poglavje 4. 4). ni
treatment.
Potem je treba zdravljenje prekiniti.
If no signs of improvement are seen after two weeks of treatment, further treatment options ic
Če po dveh lo
should be considered.
Protopy se lahko vi
Protopy can be used for short term and intermittent long term treatment.
uporablja za kratkoročno in intermitentno dolgoročno zdravljenje.
At the first signs of recurrence (flares) of the disease symptoms, treatment should be re-initiated. ed
Ob prvih znakih recidiva (ponovitve) simptomov bolezni je treba zdravljenje znova začeti. ra
Use in adults (16 years of age and above) Protopy is available in two strengths, Protopy 0.03% and Protopy 0.1% ointment.
Uporaba pri odraslih (16 let in več) Protopy je na voljo v dveh jakostih: kot Protopy 0, 03% in Protopy 0, 1% mazilo.
Treatment should be started with Protopy 0.1% twice a day and treatment should be continued until clearance of the lesion.
Zdravljenje je treba začeti s Protopyom 0, 1% dvakrat na dan in ga nadaljevati, dokler spremembe ne izginejo.
If symptoms recur, twice daily treatment with Protopy 0.1% should be restarted.
Če se simptomi znova pojavijo, je ponovno treba začeti zdravljenje s Protopyom 0, 1% dvakrat na dan.
An attempt should be made to reduce the frequency of application or to use the lower strength Protopy 0.03% ointment if the clinical condition allows.
Protopy 0, 03% mazilo.
ed 4.4 Special warnings and precautions for use
et 4. 4 Posebna opozorila in previdnostni ukrepi
is Protopy should not be used in patients with congenital or acquired immunodeficiencies or in patients
m Protopya ne smete uporabljati pri bolnikih s prirojeno ali pridobljeno imunsko pomanjkljivostjo in
or on therapy that cause immunosuppression.
o bolnikih, ki prejemajo imunosupresivno terapijo.
th The effect of treatment with Protopy ointment on the developing immune system of children, especially the young, has not yet been established and this should be taken into account when
pr Učinek zdravljenja z mazilom Protopy na razvijajoči se imunski sistem otrok, posebno mlajših, ni
au prescribing to this age group (see section 4.1).
za ugotovljen; to je treba upoštevati, kadar se zdravilo predpisuje v tej starostni skupini (glejte poglavje 4. 1).
Exposure of the skin to sunlight should be minimised and the use of ultraviolet (UV) light from a
a Izpostavljenost kože sončni svetlobi je treba omejiti na najmanjšo mero; med zdravljenjem z mazilom Protopy se je treba izogibati uporabi ultravijolične (UV) svetlobe v solarijih in zdravljenju z UVB ali
er solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use of Protopy ointment (see section 5.3).
nj UVA v kombinaciji s psoraleni (PUVA) (glejte poglavje 5. 3).