natgillin/translations-raw huggingface dataset:
Treat each affected region of your skin until the eczema has gone away.
et Prizadete predele kože zdravite, dokler ekcem ne izgine.
is within one week.
Izboljšanje je ponavadi vidno v enem tednu.
If you do not see any improvement after two weeks, see your doctor about other
Če po dveh tednih ne opazite izboljšanja, se z zdravnikom posvetujte o drugih možnih načinih zdravljenja.
or possible treatments.
m Če se simptomi znova pojavijo, je mogoče zdravljenje s Protopyom ponoviti.
Treatment with Protopy may be repeated if symptoms reappear.
o Če pomotoma zaužijete nekaj mazila
Do
pr Če pomotoma zaužijete mazilo, se čim prej posvetujte z zdravnikom ali farmacevtom.
au not try to induce vomiting.
Ne poskušajte izzvati bruhanja.
If you forget to use Protopy
za Če ste pozabili uporabiti zdravilo Protopy Če mazilo pozabite nanesti ob predvidenem času, ga nanesite, čim se spomnite, in nato nadaljujte kot
er If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then continue as before. ng If you have any further questions on the use of this product, ask your doctor or pharmacist. lo no
a prej.
4.
nj Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom. lje vo 4.
Like all medicines, Protopy can cause side effects, although not everybody gets them. ct
Kot vsa zdravila ima lahko tudi zdravilo Protopy neželene učinke, ki pa se ne pojavijo pri vseh bolnikih. do
Approximately half of the patients who use Protopy have some type of skin irritation where they have du
Približno polovica bolnikov, ki uporabljajo Protopy, občuti neko vrsto draženja kože na mestu nanosa ā
applied the ointment.
mazila.
Other common ro
Ti simptomi so ponavadi blagi do zmerni in praviloma minejo v enem tednu uporabe Protopya.
(> 1%) side effects are redness, feeling of warmth, pain, increased skin sensitivity (especially to hot and cold), skin tingling, rash, folliculitis (inflamed or infected hair follicles) and herpes viral infections lp
Drugi pogosti (> 1%) neželeni učinki so ve
(e. g. cold sores, generalised herpes simplex infections).
razširjene okužbe s herpes simplex).
Rosacea and rosacea-like dermatitis have a
Opazili so tudi rozaceo in rozaceji podobno vnetje kože. m
Since commercial availability a very small number of people who have used Protopy ointment have in
Odkar je zdravilo dostopno na trgu, so se pri zelo maloštevilnih bolnikih, ki so uporabljali mazilo ni
had malignancies (for example, skin or lymphoma).
Protopy, pojavili malignomi (npr. na koži ali limfom).
However, a link to Protopy ointment treatment has ic
Vendar povezave z uporabo mazila Protopy na podlagi dosedanjih ugotovitev niso niti potrdili niti ovrgli. lo
not been confirmed or refuted on the available evidence so far. ed
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem vi
M
navodilu, obvestite svojega zdravnika ali farmacevta. ra
HOW TO STORE PROTOPY
SHRANJEVANJE ZDRAVILA PROTOPY Zd
ed is or th au er ng lo no ct du ro ed M
37 Zd ra vi lo ni m a ve ā
38 6.
38 do vo lje nj a za pr om et 6.
One gram of Protopy 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
En gram mazila Protopy 0, 03% vsebuje 0, 3 mg takrolimusa (v obliki takrolimus monohidrata).
What Protopy looks like and contents of the pack Protopy is a white to slightly yellowish ointment.
Izgled zdravila Protopy in vsebina pakiranja Protopy je belo do rahlo rumenkasto mazilo.
Protopy is available in two strengths (Protopy 0.03%
Protopy je na voljo v dveh jakostih (Protopy 0, 03% in Protopy 0, 1% mazilo).
Marketing Authorisation Holder:
et Imetnik dovoljenja za promet z zdravilom:
is Germany.
m München, Nemčija.
or Manufacturer:
o Izdelovalec:
th For any information about this medicinal product, please contact the local representative of the
pr Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika
au Marketing Authorisation Holder.
za dovoljenja za promet z zdravilom:
er Astellas Pharma B. V.
a Astellas Pharma B. V.
Branch Erasmus Park/ Parc Erasme Square Marie Curie 50 B-1070 Brüssel/ Bruxelles
nj Erasmus Park/ Parc Erasme Square Marie Curie 50
Branch Erasmus Park/ Parc Erasme ng Square Marie Curie 50 B-1070 Brüssel/ Bruxelles
Erasmus Park/ Parc Erasme Square Marie Curie 50 lje
no
do
България Астелас Фарма Юръп Б .В. /ЕВАГ
България Астелас Фарма Юръп Б. В. / ЕВАГ ул.
ct
ā
Meteor Centre Office Park Sokolovskà 100/ 94 a
Meteor Centre Office Park m
CZ-18600 Praha 8 Tel: +420 236 080300 in ic
CZ- 18600 Praha 8 Tel: +420 236 080300 lo
Danmark Astellas Pharma a/ s ed
Danmark vi
Naverland 4 DK-2600 Glostrup M
Astellas Pharma a/ s Naverland 4 ra
Tlf: +45 43 430355
DK- 2600 Glostrup Tlf: +45 43 430355 Zd
ed Τηλ: + 30 210 2812640
et Τηλ: + 30 210 2812640
is Astellas Pharma S. A.
m España Astellas Pharma S. A.
or Paseo del Club Deportivo n° 1 Bloque 14-2a
o Paseo del Club Deportivo n° 1
Edifício Cinema Rua José Fontana, n. °1, 1°Andar
Rua José Fontana, n. °1, 1°Andar P- 2770- 101 Paço de Arcos
th E-28223 Pozuelo de Alarcón, Madrid Tel: +34 91 4952700
za Tel: +34 91 4952700
P-2770-101 Paço de Arcos Tel: +351 21 4401320
Tel: +351 21 4401320
România Astellas Pharma International
Astellas Pharma International Detalii de contact pentru Romania lje
er 114 rue Victor Hugo F-92300 Levallois Perret Tél: +33 (0)1 55917500
F- 92300 Levallois Perret Tél: +33 (0) 1 55917500
lo
vo do
Astellas Pharma Co.
Ireland Astellas Pharma Co.
Pharmaswiss d. o. o.
Slovenija Pharmaswiss d. o. o.
IRL-Dublin 22 Tel: +353 (0)1 4671555
Kilcarbery Business Park, Clondalkin IRL- Dublin 22 ve
Tel: +386 1 2364700
Tel: +353 (0) 1 4671555 a
lp
ni
Astellas Pharma s. r. o., organizač ná zlož ka Záborského 29
Záborského 29
IS-210 Garðabæ Sími: +354 535 7000 a
IS- 210 Garðabæ Sími: +354 535 7000 lo
Italia
Italia vi
Via delle Industrie 1 I-20061 Carugate (Milano) ed
Via delle Industrie 1 ra
Tel: +39 (0)2 921381 M
I- 20061 Carugate (Milano) Tel: +39 (0) 2 921381 Zd
ed LT-03228 Vilnius Tel. +370 (5) 2394155
et LT- 03228 Vilnius Tel. +370 (5) 2394155
is or This leaflet was last approved in {MM/ YYYY}
m o Navodilo je bilo odobreno {MM/ LLLL}
th Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
pr Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA)
au er ng lo no ct du ro ed M
a nj lje vo do ā ve a m ni lo vi ra Zd
WHAT PROTOPY IS AND WHAT IT IS USED FOR ng The active substance of Protopy, tacrolimus monohydrate, is an immunomodulating agent. lo Protopy 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are no
KAJ JE ZDRAVILO PROTOPY IN ZA KAJ GA UPORABLJAMO lje Zdravilna učinkovina Protopya, takrolimus monohidrat, je imunomodulacijsko sredstvo. vo Protopy 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 do
not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
ustrezno ali jih ne prenašajo.
Protopy alters the abnormal immune response and relieves the skin ct
Protopy spremeni nenormalen imunski odziv in ā
inflammation and the itch. du
odpravi vnetje in srbenje kože. ve
BEFORE YOU USE PROTOPY ro
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PROTOPY a
Do not use Protopy lp
Ne uporabljajte zdravila Protopy m
macrolide antibiotics (e. g. azithromycin, clarithromycin, erythromycin). a
makrolidne antibiotike (npr. azitromicin, klaritromicin, eritromicin).
Take special care with Protopy in
Bodite posebno pozorni pri uporabi zdravila Protopy lo
ic
vi
ed
ra
- Also speak to your doctor before using Protopy if you have any skin malignancies (tumours) or
Pred uporabo Protopya se posvetujte z zdravnikom.
if you have a weakened immune system (immuno-compromised) whatever the cause.
- Prav tako se pred uporabo Protopya posvetujte z zdravnikom, če imate kakšen malignom (tumor)
Talk to your doctor before using Protopy.
na koži ali imate zaradi kakršnegakoli razloga oslabljen imunski sistem (ste imunsko oslabeli).
If you are prescribed light therapy, inform your doctor that you are using Protopy as it is not recommended to use Protopy and light therapy at the same time.
Sočasna uporaba Protopya in fototerapije namreč ni priporočljiva.
Taking or using other medicines and cosmetics Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
Jemanje ali uporaba drugih zdravil in kozmetičnih sredstev
ed including medicines obtained without a prescription.
et Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
You may use moisturising creams and lotions during treatment with Protopy but these products should
m Med zdravljenjem s Protopyom lahko uporabljate vlažilne kreme in losjone, vendar teh izdelkov ne
is not be used within two hours of applying Protopy.
o smete nanesti v razmiku manj kot dve uri od uporabe Protopya.
or The use of Protopy at the same time as other preparations to be used on the skin or while taking oral
pr Hkratna uporaba Protopya z drugimi pripravki, ki se uporabljajo na koži, in med jemanjem peroralnih
th corticosteroids (e. g. cortisone) or medicines which affect the immune system has not been studied.
za kortikosteroidov (npr. kortizona) ali zdravil, ki vplivajo na imunski sistem, ni raziskana.
au Before receiving a vaccination tell your doctor that you are using Protopy (see Section “ Take special care with Protopy”).
Preden dobite kakšno cepivo, zdravniku povejte, da uporabljate Protopy (glejte poglavje "Bodite
er Using Protopy with food and drink While using Protopy, drinking alcohol may cause the skin or face to become flushed or red and feel hot. ng lo Pregnancy and breast-feeding Don’ t use Protopy if you are pregnant or breast-feeding. no
nj Uporaba zdravila Protopy skupaj s hrano in pijačo lje Med uporabo Protopya lahko pitje alkohola povzroči, da koža na obrazu pordi in je vroča na otip. vo Nosečnost in dojenje Ne uporabljajte Protopya, če ste noseči ali če dojite.
Ask your doctor or pharmacist for advice before taking any medicine. ct
Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo. do
HOW TO USE PROTOPY du
KAKO UPORABLJATI ZDRAVILO PROTOPY ā ve
You should check with your doctor or pharmacist if you are not sure. ro
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom. a
Apply Protopy as a thin layer to affected areas of your skin. lp
Protopy na tanko namažite na prizadete predele kože. m
Protopy may be used on most parts of the body, including the face and neck and in the creases of your a
Protopy se lahko uporablja na večini delov telesa, tudi na obrazu, vratu in v komolčnih in kolenskih ni
elbows and knees. in
pregibih. lo
If the ointment gets on any of ic
Če pride mazilo na katerega od teh predelov, ga morate vi
these areas, it should be thoroughly wiped off and/ or rinsed off with water. ed
z njega temeljito obrisati in/ ali splakniti z vodo. ra
Two strengths of Protopy (Protopy 0.03% and Protopy 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 Protopya (Protopy 0, 03% in Protopy 0, 1% mazilo).
Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Protopy 0.03% ointment, can be used.
Glede na odziv ekcema bo zdravnik presodil, ali je mogoče pogostnost uporabe zmanjšati ali uporabiti manjšo jakost, mazilo Protopy 0, 03%.
If you forget to use Protopy If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then continue as before.
Če ste pozabili uporabiti zdravilo Protopy Če mazilo pozabite nanesti ob predvidenem času, ga nanesite, čim se spomnite, in nato nadaljujte kot prej.
ed If you have any further questions on the use of this product, ask your doctor or pharmacist.
et Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
is or 4.
m o 4.
th Like all medicines, Protopy can cause side effects, although not everybody gets them.
pr Kot vsa zdravila ima lahko tudi zdravilo Protopy neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
au Approximately half of the patients who use Protopy have some type of skin irritation where they have applied the ointment.
za Približno polovica bolnikov, ki uporabljajo Protopy, občuti neko vrsto draženja kože na mestu nanosa mazila.
Other common
Ti simptomi so ponavadi blagi do
er (> 1%) side effects are redness, feeling of warmth, pain, increased skin sensitivity (especially to hot and cold), skin tingling, rash, folliculitis (inflamed or infected hair follicles) and herpes viral infections ng (e. g. cold sores, generalised herpes simplex infections).
Drugi pogosti (> 1%) neželeni učinki so
Rosacea and rosacea-like dermatitis have lo also been reported.
Opazili so tudi rozaceo in rozaceji podobno vnetje kože. vo Odkar je zdravilo dostopno na trgu, so se pri zelo maloštevilnih bolnikih, ki so uporabljali mazilo Protopy, pojavili malignomi (npr. na koži ali limfom).
Since commercial availability a very small number of people who have used Protopy ointment have no
Vendar povezave z uporabo mazila Protopy na do
had malignancies (for example, skin or lymphoma).
podlagi dosedanjih ugotovitev niso niti potrdili niti ovrgli.
However, a link to Protopy ointment treatment has not been confirmed or refuted on the available evidence so far. ct
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem ā
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. du ro
navodilu, obvestite svojega zdravnika ali farmacevta. ve
HOW TO STORE PROTOPY lp
SHRANJEVANJE ZDRAVILA PROTOPY a
Keep out of the reach and sight of children. a
Zdravilo shranjujte nedosegljivo otrokom! m ni
Do not use Protopy after the expiry date which is stated on the tube and carton after EXP.
Zdravila Protopy ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na tubi in škatli poleg oznake » Uporabno do: «.
The expiry date refers to the last day of that month. in
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca. lo
Do not store above 25ºC. ic
Shranjujte pri temperaturi do 25 °C. vi
Ask your pharmacist how to ed
O načinu odstranjevanja ra
One gram of Protopy 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
En gram mazila Protopy 0, 1% vsebuje 1, 0 mg takrolimusa (v obliki takrolimus monohidrata).
CZ-18600 Praha 8 Tel: +420 236 080300 in ic
CZ- 18600 Praha 8 Tel: +420 236 080300 lo vi
Danmark Astellas Pharma a/ s ed
Danmark Astellas Pharma a/ s ra
Naverland 4 DK-2600 Glostrup M
Naverland 4 DK- 2600 Glostrup Zd
au France Astellas Pharma S. A. S.
a Astellas Pharma S. A. S.
România Astellas Pharma International
Astellas Pharma International
er 114 rue Victor Hugo F-92300 Levallois Perret Tél: +33 (0)1 55917500
nj 114 rue Victor Hugo F- 92300 Levallois Perret
25, The Courtyard Kilcarbery Business Park, Clondalkin ct
25, The Courtyard Kilcarbery Business Park, Clondalkin ā
du
ve
ro
a
Italia
Italia lo
Astellas Pharma S. p. A. ic
Astellas Pharma S. p. A. vi
Via delle Industrie 1 I-20061 Carugate (Milano) ed
Via delle Industrie 1 I- 20061 Carugate (Milano) ra
PL 13 FIN-02611 Espoo/ Esbo
PL 13 FIN- 02611 Espoo/ Esbo
Tel: +39 (0)2 921381 M
Tel: +39 (0) 2 921381 Zd
Protopy is a dermatological medicinal product that contains the calcineurin inhibitor tacrolimus at a 0.1% and 0.03% concentration.
Protopy je dermatološko zdravilo, ki vsebuje takrolimus, zaviralec kalcineurina, v koncentraciji 0, 1% in 0, 03%.
Protopy 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 Protopy 0.03% is indicated for the treatment of moderate to severe AD in adults or
Zdravilo Protopy 0, 1% je namenjeno zdravljenju zmernega do hudega atopičnega dermatitisa (AD) pri odraslih, ki se na konvencionalne terapije ne odzovejo ustrezno ali jih ne prenesejo, zdravilo Protopy 0, 03% pa je namenjeno zdravljenju zmernega do hudega atopičnega dermatitisa (AD) pri
ed children (2 years of age and above) who failed to respond adequately to conventional therapies.
et odraslih ali otrocih (starih 2 leti ali več), ki se na konvencionalne terapije ne odzovejo ustrezno.
is 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 Protopy.
m Dne 21. aprila 2005 je Evropska komisija zaprosila Odbor za zdravila za uporabo v humani medicini
Following this request, the CHMP
o (CHMP) za mnenje o razmerju med koristmi in tveganji za zdravilo Protopy z vidika potencialnega
or reviewed the available data on this safety issue, including post-marketing reports, data from non-
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.
th clinical studies, clinical trials and epidemiological studies.
za Limfom je splošno poznan in v literaturi naveden neželen učinek sistemsko uporabljenih zdravil, ki
au Lymphoma is a recognised and listed adverse effect for systemically administered calcineurin inhibitor products.
a vsebujejo zaviralce kalcineurina.
This effect is thought to be mediated by the immunosuppression caused as a result of systemic treatment with the product.
Do tega učinka domnevno prihaja zaradi imunosupresije, povzročene s
Systemic exposure is limited with the topical use of tacrolimus,
nj sistemsko uporabo tega zdravila.
er however a local immunosuppressive effect in the skin cannot be excluded. ng 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 lo
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). do
development and post-marketing experience in association with the use of Protopy.
Predloženi podatki niso pokazali nedvoumne povezave z limfomom ali katerim drugim malignim obolenjem.
The data presented did not show a definite association with lymphoma or any malignancy.
Kljub temu pa se zdi, da se bolniki s CTCL pojavljajo v večjem številu, kot bi pričakovali.
However there appeared to be no
CHMP se je strinjal, da je diagnozo teh kožnih malignih obolenj težko postaviti ter da so ta obolenja ā
an increase in numbers of patients with CTCL, relative to what would be expected.
lahko podobna atopičnemu dermatitisu.
However, having ct
Vendar pa je CHMP, na podlagi pregleda razpoložljivih ve
reviewed the available data, the CHMP concluded that not all cases could be considered to be cases of pre-existing malignancy disease, and an association with tacrolimus could not be excluded in some of du
podatkov, ocenil, da vseh primerov ni mogoče obravnavati kot predhodno obstoječa maligna obolenja ter da povezave s takrolimusom v določenih primerih ni mogoče izključiti. a m
However, considering that tacrolimus is effective through its lp
Vendar pa glede na to, da takrolimus učinkuje na podlagi supresije ni
suppression of T cells which are involved in immune surveillance, it is possible that tacrolimus could have an effect on the behaviour of cutaneous lesions which were either pre-malignant or cases of early a
celic T, ki so vključene v delovanje imunskega sistema, obstaja možnost, da bi takrolimus lahko imel učinek na obnašanje kožnih lezij, ki so bodisi predmaligna obolenja ali primeri malignega obolenja v lo
malignancy.
zgodnji fazi.
transduction pathways in T cells which results in prevention of transcription and synthesis of IL-2, IL- ic
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. vi
As tacrolimus is an effective immunosuppressant that acts by suppressing T lymphocytes in the skin, the CHMP was of the opinion that an effect of tacrolimus on ed
Ker je takrolimus učinkovit imunosupresiv, ki deluje preko supresije limfocitov T v koži, je bil CHMP ra
the development or progression of a variety of skin lesions could not be excluded.
mnenja, da učinka takrolimusa na razvoj ali napredovanje različnih kožnih lezij ni mogoče izključiti.
Additionally, the CHMP concluded that Protopy should not be used in immunocompromised adults or children and that Protopy 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 Protopy 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 Protopy 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 Protopy pri otrocih, starih manj kot dve leti (uporaba ni odobrena), pri katerih se imunski sistem šele razvija.
The CHMP also concluded that the potential role of tacrolimus in the pathogenesis of CTCL should be further investigated through mechanistic studies.
Nadalje je CHMP sklenil, da je treba potencialno vlogo takrolimusa
ed is GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
m o PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN
or Whereas
pr NAVODIL ZA UPORABO
th au
Ker
Protopy
a Protopy.
- The Committee acknowledged that cases of malignancy (including skin cancer and lymphoma)
- je Odbor vzel na znanje, da so pri bolnikih, zdravljenih z zdravilom Protopy, poročali o primerih
have been reported in patients treated with Protopy.
lje malignih obolenj (vključujočih kožni rak in limfom).
In view of the available data (including pre- ng clinical, clinical and epidemiological) the CHMP concluded that a potential association with the use of Protopy cannot be ruled out and therefore further data are needed to ensure an acceptable lo
CHMP je na podlagi razpoložljivih podatkov (vključujočih predklinične, klinične in epidemiološke podatke) zaključil, da vo
long-term safety profile. no
potencialne povezave z uporabo zdravila Protopy ni mogoče izključiti in da je zaradi tega potrebno zbrati dodatne podatke, ki bi zagotovili sprejemljiv dolgoročni varnostni profil. do
in the Summary of Product Characteristics and relevant sections of the Package Leaflet of Protopy: ct du
razdelke Navodil za uporabo za zdravilo Protopy vključiti naslednje informacije: ā ve
The treatment with Protopy should only be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. ro
Zdravljenje z zdravilom Protopy sme uvesti le zdravnik, ki ima izkušnje z diagnostiko in z zdravljenjem atopičnega dermatititsa. a
•
• m
The tre atment should be intermittent and not continuous.
Zdravljenje mora potekati z vmesnimi prekinitvami in ne kontinuirano. ni
lp
lo
are considered to be potentially malignant or pre-malignant. in
Opozorilo, ki bo poudarilo, da takrolimusa ni dovoljeno nanašati na lezije, ki so ocenjene kot potencialno maligne ali predmaligne.
Protopy should not be used in immunocompromised adults or children.
Zdravila Protopy se ne sme uporabljati pri odraslih ali otrocih z oslabljenim
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,