natgillin/translations-raw huggingface dataset:
The incidence of local skin burning was higher in the tacrolimus treatment lp
Incidenca lokalnega pekočega občutka na koži je bila v skupinah s takrolimusom večja kot v skupini s hidrokortizonom.
There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the study. a in
a skupini niso pojavile klinično pomembne spremembe laboratorijskih vrednosti ali vitalnih znakov.
In the fourth trial, approximately 800 patients (aged ≥ 2 years) received 0.1% tacrolimus ointment intermittently or continuously in an open-label, long-term safety study for up to four years, with 300 ic
nj V četrti študiji, odprti, dolgoročni raziskavi varnosti, je približno 800 bolnikov (starih ≥ 2 leti) do štiri lje leta intermitentno ali stalno dobivalo 0, 1% mazilo s takrolimusom; 300 bolnikov je bilo zdravljenih vsaj tri leta, 79 bolnikov pa je zdravljenje dobivalo najmanj 42 mesecev.
patients receiving treatment for at least three years and 79 patients receiving treatment for a minimum ed
Poleg tega do
of 42 months.
med klinično raziskavo niso opazili znakov zmanjševanja učinkovitosti.
Based on changes from baseline in EASI score and body surface area affected, patients regardless of age had improvement in their atopic dermatitis at all subsequent time points.
Celotna incidenca neželenih učinkov se je med potekom raziskave zmanjševaal pri vseh bolnikih, ne glede na starost.
The overall M
Trije najpogosteje opisani neželeni učinki so bili gripi podobni simptomi (prehlad, nahod, influenca okužba ā
incidence of adverse events tended to decrease as the study progressed for all patients independent of age.
Med to dolgoročno raziskavo niso zabeležili ve
The three most common adverse events reported were flu-like symptoms (cold, common cold, influenza, upper respiratory infection, etc.), pruritus and skin burning.
neželenih učinkov, ki ne bi bili že pred tem opisani v kratkotrajnejših in/ ali prejšnjih raziskavah.
No adverse events previously unreported in shorter duration and/ or previous studies were observed in this long-term study.
Klinični podatki kažejo, da je koncentracija takrolimusa v sistemskem obtoku po lokalni uporabi majhna m
5.2 Pharmacokinetic properties
in da je v primerih, ko je merljiva, prehodna. ni
Clinical data have shown that tacrolimus concentrations in systemic circulation after topical administration are low and, when measurable, transient.
Absorpcija Podatki iz raziskav zdravih preiskovancev kažejo, da je sistemska izpostavljenost takrolimusu po lo
16 Absorption Data from healthy human subjects indicate that there is little or no systemic exposure to tacrolimus following single or repeated topical application of tacrolimus ointment.
posamični ali ponavljajoči se lokalni uporabi mazila s takrolimusom majhna ali je sploh ni. vi
Most atopic dermatitis patients (adults and children) treated with single or repeated application of tacrolimus ointment (0.03 - 0.1%), and infants from age of 5 months treated with tacrolimus ointment (0.03%) had blood concentrations < 1.0 ng/ ml.
Pri večini bolnikov z atopičnim dermatitisom (odraslih in otrok), zdravljenih s posamično ali ponavljajočo se uporabo mazila s takrolimusom (0, 03 - 0, 1%), in dojenčkih starih 5 mesecev ali več ra
Systemic exposure increases with increasing treatment areas.
Sistemska izpostavljenost narašča z Zd
However, both the extent and the rate of topical absorption of tacrolimus decrease as the skin heals.
velikostjo zdravljenih predelov, vendar se obseg in hitrost lokalne absorpcije takrolimusa zmanjšujeta, ko se stanje kože izboljšuje.
AUC) of tacrolimus from Protopy is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
AUC) takrolimusa iz Protopya približno 30- krat manjša kot po peroralnih imunosupresivnih odmerkih pri bolnikih s presajenimi ledvicami ali jetri.
There was no evidence of systemic accumulation of tacrolimus in patients (adults and children) treated for prolonged periods (up to one year) with tacrolimus ointment.
Najmanjša koncentracija takrolimusa v krvi, pri kateri je mogoče ugotoviti sistemske učinke, ni znana.
is or Distribution As systemic exposure is low with tacrolimus ointment, the high binding of tacrolimus (> 98.8%) to
Pri bolnikih (odraslih in otrocih), ki so se dolgo (do eno leto) zdravili z mazilom s takrolimusom, ni bilo znakov sistemskega kopičenja takrolimusa.
Following topical application of tacrolimus ointment, tacrolimus is selectively delivered to the skin
Distribucija Sistemska izpostavljenost je med uporabo mazila s takrolimusom majhna, zato velika vezava takrolimusa (> 98, 8%) na beljakovine v plazmi ne velja za klinično pomembno.
au with minimal diffusion into the systemic circulation.
16 Po lokalni uporabi mazila s takrolimusom se takrolimus selektivno sprošča v kožo in le minimalno difundira v sistemski obtok.
er Metabolism of tacrolimus by human skin was not detectable.
Presnova V človeški koži ni bilo mogoče odkriti presnove takrolimusa.
Elimination ng lo When administered intravenously, tacrolimus has been shown to have a low clearance rate.
Eliminacija Ugotovljeno je, da je očistek intravensko uporabljenega takrolimusa majhen.
tacrolimus could be reduced in subjects with severe hepatic impairment, or in subjects who are co- treated with drugs that are potent inhibitors of CYP3A4.
Jetrni očistek sistemsko razpoložljivega takrolimusa bi se lahko zmanjšal pri osebah s hudo okvaro jeter ali osebah, ki se sočasno zdravijo z močnimi zaviralci CYP3A4.
estimated to be 75 hours for adults and 65 hours for children. du
et Po večkratni lokalni uporabi mazila je bil ocenjeni povprečni razpolovni čas takrolimusa pri odraslih 75 ur in pri otrocih 65 ur.
5.3 Preclinical safety data ro
m 5. 3 Predklinični podatki o varnosti
Repeated dose toxicity and local tolerance Repeated topical administration of tacrolimus ointment or the ointment vehicle to rats, rabbits and lp
o pr Toksičnost ponavljajočih se odmerkov in lokalno prenašanje Večkratno lokalno aplikacijo mazila s takrolimusom ali vehikla mazila pri podganah, kuncih in
micropigs was associated with slight dermal changes such as erythema, oedema and papules.
za mikroprašičkih so spremljale rahle dermalne spremembe, npr. eritem, edem in papule.
The changes were caused by high systemic exposure of a
Spremembe je povzročila velika
Slightly lower body weight gain in in
a sistemska izpostavljenost glodalcev, ki je bila posledica velike transdermalne absorpcije takrolimusa.
females was the only systemic change observed in micropigs at high ointment concentrations (3%). ic
Edina sistemska sprememba, ki so jo pri velikih koncentracijah mazila (3%) ugotavljali pri
Rabbits were shown to be especially sensitive to intravenous administration of tacrolimus, reversible cardiotoxic effects being observed. ed
nj mikroprašičkih, je bilo nekoliko manjše pridobivanje telesne teže samic. lje Ugotovljeno je, da so kunci posebej občutljivi za intravensko uporabljeni takrolimusa; opažali so reverzibilne toksične učinke na srcu. vo Mutagenost Preizkusi in vitro in in vivo niso pokazali, da bi imel takrolimus genotoksičen potencial. do
Carcinogenicity Systemic carcinogenicity studies in mice (18 months) and rats (24 months) revealed no carcinogenic potential of tacrolimus.
Kancerogenost Raziskave sistemske kancerogenosti pri miših (18 mesecev) in podganah (24 mesecev) niso odkrile ā
In the same study an increased incidence of lymphoma was detected in association with high systemic exposure.
V isti raziskavi so ob veliki sistemski izpostavljenosti zabeležili večjo incidenco limfomov. a
In a photocarcinogenicity study, albino hairless mice were chronically treated with tacrolimus ointment and UV radiation.
V raziskavi fotokancerogenosti so brezdlakave albine miši kronično zdravili z mazilom s takrolimusom m
Animals treated with tacrolimus ointment showed a statistically significant reduction in time to skin tumour (squamous cell carcinoma) development and an increase in the
Pri živalih, ki so jim aplicirali mazilo s takrolimusom, so ugotovili statistično značilno krajši čas do pojava kožnega tumorja (skvamozni celični karcinom) in zvečanje števila ni
17 number of tumours.
tumorjev.
The risk for humans cannot be completely ruled out as the potential for local immunosuppression with the long-term use of tacrolimus ointment is unknown.
Tveganja za človeka ni mogoče povsem izključiti, ker možnost lokalne imunosupresije med dolgotrajno lo
Reproduction toxicity Embryo/ foetal toxicity was observed in rats and rabbits, but only at doses that caused significant toxicity in maternal animals.
Pri podganah in kuncih so opažali toksičnost za zarodek/ plod, vendar le v odmerkih, ki so povzročili pomembne toksične učinke pri samicah- materah.
Reduced sperm function was noted in male rats at high subcutaneous doses of tacrolimus.
odmerkih takrolimusa opazili slabšo funkcijo semenčic.
or Liquid paraffin Propylene carbonate
Beli vazelin Tekoči parafin Propilenkarbonat Beli vosek Trdi parafin
au 6.2 Incompatibilities
6. 2 Inkompatibilnosti
er Not applicable.
et Navedba smiselno ni potrebna.
Shelf life
m 6. 3 Rok uporabnosti
3 years no
o pr 3 leta
6.4 Special precautions for storage
za 6. 4 Posebna navodila za shranjevanje
Do not store above 25°C. ct
Shranjujte pri temperaturi do 25 °C.
6.5 Nature and contents of container du
a nj 6. 5 Vrsta ovojnine in vsebina
Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene ro
lje Laminatna tuba z notranjo prevleko iz polietilena majhne gostote, opremljena z belo polipropilensko navojno zaporko. vo Velikosti pakiranj:
Not all pack sizes may be marketed. a
Na trgu ni vseh navedenih pakiranj. do
6.6 Special precautions for disposal in
6. 6 Posebni varnostni ukrepi za odstranjevanje ā
No special requirements. ic
Ni posebnih zahtev.
Any unused product or waste material should be disposed of in accordance with local requirements. ed
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi. ve a
MARKETING AUTHORISATION HOLDER M
IMETNIK DOVOLJENJA ZA PROMET m
61 D-81673 München Germany
61 D- 81673 München Nemčija lo vi
MARKETING AUTHORISATION NUMBERS
ŠTEVILKE DOVOLJENJ ZA PROMET ra
EU/ 1/ 02/ 202/ 003 EU/ 1/ 02/ 202/ 004 18 EU/ 1/ 02/ 202/ 006
EU/ 1/ 02/ 202/ 004 EU/ 1/ 02/ 202/ 006
ed {DD/ MM/ YYYY}
18 {DD/ MM/ LLLL}
or Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu.
th au er ng lo no ct du ro
et m o pr za a nj lje vo do ā ve a m ni lo vi ra Zd
19 ed is or th au er ANNEX II
19 et m o pr za a nj DODATEK II lje
CONDITIONS OF THE MARKETING AUTHORISATION ct du ro
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, vo ODGOVOREN ZA SPROŠČANJE SERIJE
a
vi ra Zd
lp
B. ni lo
in ic ed M
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM do ā ve a m
ed B CONDITIONS OF THE MARKETING AUTHORISATION
et B.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
is THE MARKETING AUTHORISATION HOLDER
m • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
or Medicinal product subject to restricted medical prescription (See Annex I:
o pr Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I:
th Characteristics, section 4.2).
Povzetek glavnih značilnosti zdravila, poglavje 4. 2).
au • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
za • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
er Not applicable.
a nj Navedba smiselno ni potrebna.
ng lo no ct du ro ed M
lje vo do ā ve a m ni lo vi ra Zd
21 ed is or th au er ANNEX III ng LABELLING AND PACKAGE LEAFLET lo no ct du ro lp a in ic ed M
21 et mo pr za a nj DODATEK III lje OZNAČEVANJE IN NAVODILO ZA UPORABO vo do ā ve a m ni lo vi ra Zd
22 M ed ic in alp ro du ct
22 Zd ra vi lo ni m a ve ā
23 no
23 do A.
ng er au th or is ed PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OZNAČEVANJE vo lje nj a za pr om et PODATKI NA ZUNANJI OVOJNINI
PROTOPY 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
PROTOPY 0, 03% MAZILO (10 g, 30 g, 60 g ŠKATLA)
Protopy 0.03% Ointment Tacrolimus monohydrate
Protopy 0, 03% mazilo Takrolimus monohidrat
ed 2.
et m 2.
is 1 g ointment contains:
o 1 g mazila vsebuje:
or th 3.
pr 3.
au white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin.
za beli vazelin, tekoči parafin, propilenkarbonat, beli vosek, trdi parafin.
er 4.
a nj 4.
Ointment 10 g 30 g
lje Mazilo vo 10 g 30 g do
60 g
60 g ā
METHOD AND ROUTE OF ADMINISTRATION du
POSTOPEK IN POT UPORABE ZDRAVILA ve
Cutaneous use ro
Za dermalno uporabo a
Read the package leaflet before use. lp
Pred uporabo preberite priloženo navodilo. m ni
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT a
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK lo
Keep out of the reach and sight of children. ic ed
Zdravilo shranjujte nedosegljivo otrokom! vi ra
OTHER SPECIAL WARNING(S), IF NECESSARY M
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zd
61 D-81673 München
61 D- 81673 München Nemčija
ed Germany
et m 12.
or EU/ 1/ 02/ 202/ 005 10 g
o EU/ 1/ 02/ 202/ 005 10 g
th EU/ 1/ 02/ 202/ 001 30 g EU/ 1/ 02/ 202/ 002 60 g
pr EU/ 1/ 02/ 202/ 001 30 g EU/ 1/ 02/ 202/ 002 60 g
au 13.
za 13.
er Lot:
a nj Serija:
{number} ng lo 14.
{številka}
Medicinal product subject to medical prescription. ct
NAČIN IZDAJANJA ZDRAVILA vo Izdaja zdravila je le na recept. do
INSTRUCTIONS ON USE du
NAVODILA ZA UPORABO ā ve
INFORMATION IN BRAILLE ro lp
PODATKI V BRAILLOVI PISAVI a
Protopy 0.03% a in ic ed M
Protopy 0. 03% m ni lo vi ra Zd
PROTOPY 0.03% OINTMENT (10 g TUBE)
PROTOPY 0, 03% MAZILO (10 g TUBA)
Protopy 0.03% Ointment Tacrolimus monohydrate Cutaneous use
Protopy 0, 03% mazilo Takrolimus monohidrat Za dermalno uporabo
ed is 2.
et m 2.
or Read the package leaflet before use.
o Pred uporabo preberite priloženo navodilo.
th 3.
pr za 3.
au EXP:
Upor. do:
BATCH NUMBER
ŠTEVILKA SERIJE lje Serija:
{number} ng lo no
{številka} vo do
10 g ct du
10 g ā ve
OTHER ro
DRUGI PODATKI a
Do not store above 25°C. a
Shranjujte pri temperaturi do 25 °C. ni
Astellas Pharma GmbH in
Astellas Pharma GmbH lo
61 D-81673 München ic
61 D- 81673 München vi
Germany ed
Nemčija ra
EU/ 1/ 02/ 202/ 005 M
EU/ 1/ 02/ 202/ 005 Zd
PROTOPY 0.03% OINTMENT (30 g, 60 g TUBE)
PROTOPY 0, 03% MAZILO (30 g, 60 g TUBA)
ed 2.
et 2.
is 1 g ointment contains:
m 1 g mazila vsebuje:
Ointment 30 g 60 g
lje Mazilo vo 30 g 60 g do
METHOD AND ROUTE OF ADMINISTRATION ct du
POSTOPEK IN POT UPORABE ZDRAVILA ā ve
Cutaneous use ro
Za dermalno uporabo
Read the package leaflet before use. lp
Pred uporabo preberite priloženo navodilo. a m
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN a in
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN ni
is 12.
et 12.
th EU/ 1/ 02/ 202/ 002 60 g
o EU/ 1/ 02/ 202/ 002 60 g
au 13.
pr za 13.
er Lot:
Serija:
14.
a nj 14.
GENERAL CLASSIFICATION FOR SUPPLY ng lo Medicinal product subject to medical prescription. no
NAČIN IZDAJANJA ZDRAVILA lje Izdaja zdravila je le na recept. vo do
ic ed M
NAVODILA ZA UPORABO ā ve a m ni lo vi ra Zd
Protopy 0.1% Ointment Tacrolimus monohydrate
Protopy 0, 1% mazilo Takrolimus monohidrat
or EU/ 1/ 02/ 202/ 006 10 g
o EU/ 1/ 02/ 202/ 006 10 g
th EU/ 1/ 02/ 202/ 003 30 g EU/ 1/ 02/ 202/ 004 60 g
pr EU/ 1/ 02/ 202/ 003 30 g EU/ 1/ 02/ 202/ 004 60 g
Protopy 0.1% a in ic ed M
Protopy 0. 1% m ni lo vi ra Zd
Protopy 0.1% Ointment Tacrolimus monohydrate Cutaneous use
Protopy 0, 1% mazilo Takrolimus monohidrat Za dermalno uporabo
EU/ 1/ 02/ 202/ 006 M
EU/ 1/ 02/ 202/ 006 Zd
Read the package leaflet before use. ro lp
Pred uporabo preberite priloženo navodilo. a m
ed is 12.
et 12.
or EU/ 1/ 02/ 202/ 003 30 g EU/ 1/ 02/ 202/ 004 60 g
o EU/ 1/ 02/ 202/ 004 60 g
th au 13.
pr za 13.
ng
a nj 14.
Medicinal product subject to medical prescription. no
NAČIN IZDAJANJA ZDRAVILA lje Izdaja zdravila je le na recept. vo do
33 M ed ic in alp ro du ct
33 Zd ra vi lo ni m a ve ā
34 no
34 do
ng er au th or is ed PACKAGE LEAFLET:
lje nj a za pr om et NAVODILO ZA UPORABO
ed please tell your doctor or pharmacist.
et v tem navodilu, obvestite svojega zdravnika ali farmacevta.
is In this leaflet:
m Navodilo vsebuje:
or 1.
o 1.
What Protopy is and what it is used for 2.
pr 2.
th 3.
Kaj morate vedeti, preden boste uporabili zdravilo Protopy 3.
How to use Protopy 4.
za 4.
au 5.
Možni neželeni učinki 5.
How to store Protopy 6.
Shranjevanje zdravila Protopy 6.
er 1.
a nj 1.
WHAT PROTOPY IS AND WHAT IT IS USED FOR ng The active substance of Protopy, tacrolimus monohydrate, is an immunomodulating agent. lo Protopy 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who no
KAJ JE ZDRAVILO PROTOPY IN ZA KAJ GA UPORABLJAMO lje Zdravilna učinkovina Protopya, takrolimus monohidrat, je imunomodulacijsko sredstvo. vo Protopy 0, 03% 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
are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids.
ustrezno ali jih ne prenašajo, in pri otrocih (starih 2 leti ali več), ki se na konvencionalne načine zdravljenja, kot so lokalni kortikosteroidi, ne odzovejo ustrezno.
In atopic dermatitis, an over-reaction of the ct
Pri atopičnem dermatitisu čezmerna ā
skin’ s immune system causes skin inflammation (itchiness, redness, dryness).
reakcija imunskega sistema v koži povzroči vnetje kože (srbenje, pordelost, suhost).
Protopy alters the abnormal immune response and relieves the skin inflammation and the itch. du ro
Protopy spremeni nenormalen imunski odziv in odpravi vnetje in srbenje kože. ve
BEFORE YOU USE PROTOPY lp
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PROTOPY a m
Do not use Protopy
Ne uporabljajte zdravila Protopy ni
- If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Protopy or to
- Če ste alergični na (preobčutljivi za) takrolimus ali katerokoli sestavino zdravila Protopy ali na
macrolide antibiotics (e. g. azithromycin, clarithromycin, erythromycin). in
makrolidne antibiotike (npr. azitromicin, klaritromicin, eritromicin). lo
Take special care with Protopy ic
Bodite posebno pozorni pri uporabi zdravila Protopy vi
- Protopy ointment is not approved for children younger than 2 years of age.
- Protopy ni odobren za otroke, mlajše od 2 let.
Please consult your doctor. ed
Posvetujte se z zdravnikom. ra
- The effect of treatment with Protopy on the developing immune system in children, especially
- Učinek zdravljenja s Protopyom na razvijajoči se imunski sistem pri otrocih, posebno pri mlajših,
- The safety of using Protopy for a long time is not known.
- Varnost dolgotrajne uporabe Protopya ni znana.
have used Protopy ointment have had malignancies (for example, skin or lymphoma).
mazilo Protopy, so imeli malignome (npr. na koži ali limfom).
- Also speak to your doctor before using Protopy if you have any skin malignancies (tumours) or
- Prav tako se pred uporabo Protopya posvetujte z zdravnikom, če imate kakšen malignom (tumor)
your lymph nodes become swollen during treatment with Protopy, consult your doctor.
zdravljenjem s Protopyom otečejo bezgavke, se posvetujte z zdravnikom.
- Before receiving a vaccination tell your doctor that you are using Protopy.
- Preden dobite kakšno cepivo, zdravniku povejte, da uporabljate Protopy.
not be given during treatment and for a certain time after treatment with Protopy.
Protopyom in določen čas po zdravljenju ne smete dobiti cepiv.
you spend time outdoors after applying Protopy, use a sunscreen and wear loose fitting clothing that protects the skin from the sun.
Če greste po uporabi Protopya na prosto, uporabite sredstvo za sončenje in oblecite ohlapna oblačila, ki kožo varujejo pred soncem.
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
ed
et priporočljiva.
Taking or using other medicines and cosmetics
m Jemanje ali uporaba drugih zdravil in kozmetičnih sredstev
is Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
o Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo,
or including medicines obtained without a prescription.
pr tudi če ste ga dobili brez recepta.
th You may use moisturising creams and lotions during treatment with Protopy but these products should not be used within two hours of applying Protopy.
za Med zdravljenjem s Protopyom lahko uporabljate vlažilne kreme in losjone, vendar teh izdelkov ne smete nanesti v razmiku manj kot dve uri od uporabe Protopya.
au The use of Protopy at the same time as other preparations to be used on the skin or while taking oral corticosteroids (e. g. cortisone) or medicines which affect the immune system has not been studied.
a Hkratna uporaba Protopya z drugimi pripravki, ki se uporabljajo na koži, in med jemanjem peroralnih kortikosteroidov (npr. kortizona) ali zdravil, ki vplivajo na imunski sistem, ni raziskana.
er Before receiving a vaccination tell your doctor that you are using Protopy (see Section “ Take special care with Protopy”). ng lo Using Protopy with food and drink While using Protopy, drinking alcohol may cause the skin or face to become flushed or red and feel no
nj lje Preden dobite kakšno cepivo, zdravniku povejte, da uporabljate Protopy (glejte poglavje "Bodite posebno pozorni pri uporabi zdravila Protopy"). vo Uporaba zdravila Protopy skupaj s hrano in pijačo Med uporabo Protopya lahko pitje alkohola povzroči, da koža na obrazu pordi in je vroča na otip. do
Pregnancy and breast-feeding ct
Nosečnost in dojenje Ne uporabljajte Protopya, če ste noseči ali če dojite. ā
Ask your doctor or pharmacist for advice before taking any medicine. du ro
Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo. ve
HOW TO USE PROTOPY lp
KAKO UPORABLJATI ZDRAVILO PROTOPY a m
You should check with your doctor or pharmacist if you are not sure. a
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom. ni
Apply Protopy as a thin layer to affected areas of your skin. in ic
Protopy na tanko namažite na prizadete predele kože. lo vi
Protopy may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees. ed
Protopy se lahko uporablja na večini delov telesa, tudi na obrazu, vratu in v komolčnih in kolenskih pregibih. ra
If the ointment gets on any of M
Če pride mazilo na katerega od teh predelov, ga morate Zd
these areas, it should be thoroughly wiped off and/ or rinsed off with water.
z njega temeljito obrisati in/ ali splakniti z vodo.
36 Children (2 years of age and older) Apply Protopy twice a day for up to three weeks, once in the morning and once in the evening.
36 Otroci (stari 2 leti in več) Protopy do tri tedne uporabljajte dvakrat na dan, enkrat zjutraj in enkrat zvečer.
Adults (16 years of age and older) Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients.
Odrasli (16 let in starejši) Za odrasle bolnike sta na voljo dve jakosti Protopya (Protopy 0, 03% in Protopy 0, 1% mazilo).
Usually, treatment is started with Protopy 0.1% ointment twice a day, once in the morning and once in the evening, until the eczema has cleared.
Zdravljenje se ponavadi začne z mazilom Protopy 0, 1% dvakrat na dan, enkrat zjutraj in enkrat zvečer, dokler ekcem ne izgine.
If symptoms reappear, treatment with Protopy 0.1% twice a day should be restarted.
Če se simptomi znova pojavijo, je treba ponovno začeti uporabljati Protopy 0, 1% dvakrat na dan.
Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the
Glede na odziv ekcema bo zdravnik presodil, ali je mogoče pogostnost uporabe zmanjšati ali uporabiti manjšo jakost, mazilo Protopy 0, 03%.