FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore the CHMP concluded that the following information should be included in the Summaries of Product Characteristics and relevant sections of the Package Leaflets:
Slovenian: Poleg tega je CHMP zaključil, da morajo biti v Povzetke glavnih značilnosti zdravila in ustrezne točke Navodil za uporabo zdravila vključeni naslednji podatki:
English: Consistent with its skin selectivity, after topical application, pimecrolimus blood levels are very low.
Slovenian: V skladu s selektivnostjo pimekrolimusa za kožo po lokalni uporabi so njegove koncentracije v krvi zelo nizke.
English: <Invented Name> cream is a white, odourless, non-staining and easily spreadable cream containing 1% by weight pimecrolimus.
Slovenian: <Lastniško ime> je bela krema brez vonja, ki ne pušča madežev, se z lahkoto razmaže in vsebuje 1% pimekrolimusa (masni delež).
English: (N=267)
Slovenian: {Lastnišk o ime} (N=267)
English: In 40 adult patients treated for up to 1 year with <Invented Name>, having 14-62% of their BSA affected at baseline, 98% of pimecrolimus blood concentrations were below 0.5 ng/ml.
Slovenian: Pri 40 odraslih bolnikih, zdravljenih z {Lastniško ime} do 1 leta, ki so imeli v izhodišču prizadetih 1462% BSA, je bilo 98% koncentracij pimekrolimusa v krvi nižjih od 0,5 ng/ml.
English: In the presence of herpes simplex skin infection, <Invented Name> treatment at the site of infection should be discontinued until the viral infection has cleared.
Slovenian: Pri kožni okužbi s herpesom simpleksom je treba zdravljenje z {Lastniško ime} na mestu okužbe prekiniti, dokler se virusna okužba ne pozdravi.
English: <Invented Name> has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Slovenian: Učinkovitost in varnost {Lastniško ime} za zdravljenje klinično okuženega atopijskega dermatitisa nista ocenjeni.
English: In conclusion, pimecrolimus has a skin-selective pharmacological profile different from corticosteroids.
Slovenian: Iz tega je mogoče potegniti sklep, da ima pimekrolimus za kožo selektiven farmakološki profil, ki se razlikuje od farmakološkega profila kortikosteroidov.
English: Treatment with <Invented Name> should be discontinued until the infection has cleared.
Slovenian: Zdravljenje z <Lastniško ime> je treba prekiniti, dokler se okužba ne pozdravi.
English: When corticosteroid therapy was initiated for the treatment of flares, <Invented Name> therapy was discontinued.
Slovenian: Kadar je bila za zdravljenje izbruhov uvedena kortikosteroidna terapija, je bilo zdravljenje z {Lastniško ime} prekinjeno.
English: At the present stage, the CHMP considered that the data produced from reported epidemiological studies do not allow conclusions to be drawn regarding the potential risk of malignacies.
Slovenian: Zaenkrat je ocenil, da podatki, pridobljeni iz objavljenih epidemioloških študij, ne dajejo zadostne podlage za oblikovanje zaključkov glede možnih tveganj za nastanek malignih obolenj.
English: Treatment of patients aged 2 years and over with mild or moderate atopic dermatitis where treatment with topical corticosteroids is either inadvisable or not possible.
Slovenian: Zdravljenje bolnikov, starih 2 leti ali več, z blagim ali zmernim atopijskim dermatitisom, pri katerih zdravljenje z lokalnimi kortikosteroidi ni priporočljivo ali ni mogoče.
English: The DSMB will issue an expert report every 6 months that will be shared with all National Competent Authorities in the EU and attached to the PSUR.
Slovenian: Odbor za spremljanje podatkov o varnosti bo vsakih šest mesecev pripravil izvedensko poročilo, ki ga bo poslal pristojnim nacionalnim organom v EU in ga priložil k rednemu posodobljenemu poročilu o varnosti (PSUR).
English: Pimecrolimus was initially approved for the use in patients with mild to moderate atopic dermatitis (AD) aged 2 years and over for short-term treatment of signs and symptoms and intermittent long-term treatment for prevention of progression to flares.
Slovenian: Pimekrolimus je bil spočetka odobren za uporabo pri bolnikih z blagim do zmernim atopičnim dermatitisom (AD), starih dve leti ali več, za kratkotrajno zdravljenje znakov in simptomov in za dolgotrajno zdravljenje z vmesnimi presledki za preprečevanje širjenja obolenja.
English: 77.5% of pimecrolimus blood concentrations were below 0.5 ng/ml and 99.8% of the total samples were below 1 ng/ml.
Slovenian: 77,5% koncentracij pimekrolimusa v krvi je bilo manjših od 0,5 ng/ml, 99,8% vseh vzorcev pa je bilo manjših od 1 ng/ml.
English: In the pig model of allergic contact dermatitis, topical pimecrolimus is as effective as potent corticosteroids.
Slovenian: Lokalno uporabljeni pimekrolimus je pri prašičjem modelu alergijskega kontaktnega dermatitisa enako učinkovit kot močni kortikosteroidi.
English: The control group received <Invented Name> vehicle in order to maintain blinding.
Slovenian: Kontrolna skupina je prejemala {Lastniško ime} vehikel, da sta raziskavi ostali slepi.
English: If you apply more cream to your skin than you needed to, just wipe it off.
Slovenian: Če ste uporabili večji odmerek kreme <Lastniško ime>, kot bi smeli Če nanesete na kožo več kreme, kot bi bilo treba, jo samo obrišite.
English: Aluminium tube with a phenol-epoxy protective inner lacquer and polypropylene screw cap.
Slovenian: Aluminijasta tuba z notranjim zaščitnim fenol-epoksi lakom in s polipropilenskim pokrovčkom z navojem.
English: <[To be completed nationally]>
Slovenian: [Izpolni država članica]
English: In 8 paediatric patients aged 2-14 years, AUC (0-12h) ranged from 5.4 to 18.8 ng h/ml.
Slovenian: Pri 8 pediatričnih bolnikih, starih 2-14 let, so vrednosti AUC(0-12h) segale od 5,4 do 18,8 ng h/ml.
English: In infants (aged 3 to 23 months), the highest blood concentration measured in one patient was 2.6 ng/ml.
Slovenian: Pri najmlajših bolnikih (starih od 3 do 23 mesecev) je bila najvišja koncentracija v krvi, izmerjena pri enem bolniku, 2,6 ng/ml.
English: When the infection at treatment sites is cleared, treatment with <Invented Name> can be started.
Slovenian: Šele ko se okužba na prizadetih mestih pozdravi, se lahko začne zdravljenje z <Lastniško ime>.
English: <Invented Name> may be used on all skin areas, including the head and face, neck and intertriginous areas, except on mucous membranes.
Slovenian: {Lastniško ime} se sme uporabljati na vseh predelih kože, tudi na glavi in obrazu, vratu in intertriginoznih mestih, razen na sluznicah.
English: Do not use after the expiry date shown on the carton and tube.
Slovenian: Kreme <Lastniško ime> ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in tubi.
English: The highest blood concentrations measured in 2 paediatric patients aged 8 months to 14 years were 2.0 ng/ml.
Slovenian: Najvišja koncentracija v krvi, izmerjena pri 2 pediatričnih bolnikih, starih od 8 mesecev do 14 let, je bila 2,0 ng/ml.
English: Novartis Farma - Produtos Farmacêuticos, S.A Rua do Centro Empresarial, Edifício 8
Slovenian: Portugalska Novartis Farma - Produtos Farmacêuticos, S.A Rua do Centro Empresarial,
English: Elidel, crème 10 mg/g 10 mg per g Cream
Slovenian: Elidel, crème 10 mg/g 10 mg na g krema
English: Measuring off label use in patients without AD The MAHs should measure the use of Elidel in patients without AD and report its findings on an annual basis.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo preverjati uporabo zdravila Elidel pri bolnikih, ki nimajo atopičnega dermatitisa, in svoje ugotovitve sporočati vsako leto.
English: Pimecrolimus binds with high affinity to macrophilin-12 and inhibits the calcium-dependent phosphatase calcineurin.
Slovenian: Pimekrolimus se z veliko afiniteto veže na makrofilin-12 in zavira od kalcija odvisno fosfatazo kalcinevrin.
English: <Invented Name> treatment should begin at the first appearance of signs and symptoms of atopic dermatitis.
Slovenian: Zdravljenje z {Lastniško ime} je treba začeti pri prvem pojavu znakov in simptomov atopijskega dermatitisa.
English: - The Committee acknowledged that cases of malignancy (including skin cancer and lymphoma) have been reported in patients treated with pimecrolimus cream.
Slovenian: je Odbor potrdil, da so bila objavljena poročila o primerih malignih obolenj (vključno s kožnim rakom in limfomom) pri bolnikih, ki so bili zdravljeni s pimekrolimusom v kremi.
English: The MAHs should explain the apparent differences in pimecrolimus use in the US vs the EU.
Slovenian: Uporaba pimekrolimusa v EU v primerjavi z ZDA Imetniki dovoljenja za promet z zdravilom morajo razložiti očitne razlike pri uporabi pimekrolimusa v ZDA v primerjavi z EU.
English: Tell your doctor if you are breast-feeding before using <Invented Name> or any other medicines.
Slovenian: Če dojite, opozorite na to zdravnika preden uporabite <Lastniško ime> ali katerokoli drugo zdravilo.
English: Lymphoma study
Slovenian: Limfomska študija
English: It will meet twice a year and review all clinical trial, pharmacoepidemiology and post marketing safety data obtained with pimecrolimus.
Slovenian: Sestajal se bo dvakrat na leto in pregledal vse podatke o varnosti uporabe pimekrolimusa, ki so bili pridobljeni v kliničnih preskušanjih, farmakoepidemioloških raziskavah ter postmarketinških raziskavah varnosti zdravila.
English: No incidents of accidental ingestion have been reported.
Slovenian: Doslej niso poročali o nobenem primeru nehotenega zaužitja.
English: It is not known whether the active substance in <Invented Name> passes into the milk after application to the skin.
Slovenian: Ni znano, ali zdravilna učinkovina v <Lastniško ime> po nanosu na kožo prehaja v materino mleko.
English: <Invented Name> has no known effect on the ability to drive and use machines.
Slovenian: {Lastniško ime} nima znanega vpliva na sposobnost vožnje in upravljanja s stroji.
English: - The Committee, as a consequence, considered the benefit/risk balance of medicinal products containing pimecrolimus cream to be favourable in the “treatment of patients aged 2 years and over with mild or moderate atopic dermatitis where treatment with topical corticosteroids is either inadvisable or not possible.
Slovenian: V skladu s tem je bil Odbor mnenja, da je razmerje med koristmi in tveganji zdravil, ki vsebujejo pimekrolimus v kremi, ugodno za "zdravljenje bolnikov, starih dve leti ali več, z blagim do zmernim atopičnim dermatitisom, pri katerih zdravljenje z lokalnimi kortikosteroidi bodisi ni priporočljivo bodisi ni mogoče.
English: However, <Invented Name> should not be used during pregnancy.
Slovenian: Vendar zdravila {Lastniško ime} med nosečnostjo ne smete uporabljati.
English: Tolerability studies demonstrated that <Invented Name> has not shown contact sensitising, phototoxic or photosensitising potential, nor did they show any cumulative irritation.
Slovenian: Raziskave varnosti zdravila so pokazale, da {Lastniško ime} ne povzroča kontaktne senzitizacije, fototoksičnosti, fotosenzitizacije ali iritacije zaradi kopičenja.
English: common: application site reactions (irritation, pruritus and erythema), skin infections (folliculitis).
Slovenian: Pogosti: reakcije na mestu uporabe (draženje, srbenje in eritem), kožne okužbe (folikulitis).
English: <Invented Name> Cream is only to be used for atopic dermatitis.
Slovenian: Krema <Lastniško ime> se sme uporabljati samo za atopijski dermatitis.
English: <Invented Name> was used at first signs of itching and redness to prevent progression to flares of atopic dermatitis.
Slovenian: {Lastniško ime} je bil uporabljen ob prvih znakih srbenja in rdečice, da bi se preprečilo napredovanje v izbruh atopijskega dermatitisa.
English: <Invented Name> has not been studied in patients with Netherton's syndrome.
Slovenian: Pri bolnikih z Nethertonovim sindromom {Lastniško ime} niso proučevali.
English: • The treatment with pimecrolimus cream should only be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Slovenian: Zdravljenje s pimekrolimusom v kremi lahko uvede le zdravnik z izkušnjami z diagnosticiranjem in zdravljenjem atopičnega dermatitisa.
English: A one year double-blind study in adults with moderate to severe atopic dermatitis was conducted to compare <Invented Name> to 0,1% triamcinolone acetonide cream (for trunk and extremities) plus 1% hydrocortisone acetate cream (for face, neck and intertriginous areas).
Slovenian: Pri odraslih z zmernim do težkim atopijskim dermatitisom je bila opravljena enoletna dvojna slepa raziskava za primerjavo {Lastniško ime} s kremo z 0,1% triamcinolonacetonidom (za trup in ude) plus kremo z 1% hidrokortizonacetatom (za obraz, vrat in intertriginozne predele).
English: - If you have any further questions, ask your doctor or pharmacist (chemist).
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: (N=123)
Slovenian: {Lastnišk o ime} (N=123)
English: • Rub in gently and fully.
Slovenian: • Kremo nežno in temeljito vtrite v kožo.
English: Around 60% of pimecrolimus blood concentrations were below 0.5 ng/ml and 97% of all samples were below 2 ng/ml.
Slovenian: Okrog 60% koncentracij pimekrolimusa v krvi je bilo nižjih od 0,5 ng/ml, 97% vseh vzorcev pa je bilo pod 2 ng/ml.
English: - The Committee considered that pimecrolimus cream is effective in the treatment of mild or moderate atopic dermatitis; however the CHMP considered that the therapeutic indications should be restricted for patients where treatment with topical corticosteroids is either inadvisable or not possible.
Slovenian: je Odbor ugotovil, da je pimekrolimus v kremi učinkovit za zdravljenje blagega do zmernega atopičnega dermatitisa, vendar pa je menil, da morajo biti terapevtske indikacije omejene na bolnike, pri katerih zdravljenje z lokalnimi kortikosteroidi bodisi ni priporočljivo bodisi ni mogoče.
English: <Invented Name> cream specifically treats an inflammation of the skin called atopic dermatitis (eczema).
Slovenian: Krema <Lastniško ime> je posebej namenjena zdravljenju vnetja kože, ki ga imenujemo atopijski dermatitis (ekcem).
English: Pimecrolimus exhibits high anti-inflammatory activity in animal models of skin inflammation after topical and systemic application.
Slovenian: Pimekrolimus ima izrazito protivnetno delovanje v živalskih modelih kožnega vnetja po lokalni in sistemski uporabi.
English: <Invented Name> should not be used at the same time as ultraviolet light treatments (e.g. UVA, PUVA, UVB) or systemic immunosuppressive medicines (e.g. azathioprine or cyclosporin).
Slovenian: <Lastniško ime> se ne sme uporabljati hkrati z zdravljenjem z ultravijolično svetlobo (npr. UVA, PUVA, UVB) ali sistemskimi zdravili, ki zavirajo imunsko odzivnost (sistemskimi imunosupresivi, kot sta azatioprin ali ciklosporin).
English: Patients with severe atopic dermatitis may have an increased risk of skin bacterial infections (impetigo) during treatment with <Invented Name>.
Slovenian: Pri bolnikih s hudim atopijskim dermatitisom je lahko med zdravljenjem z {Lastniško ime} povečana nevarnost bakterijskih okužb kože (impetigo).
English: Do not apply the cream to areas of the skin affected by active viral infection such as cold sores (herpes simplex) or chicken pox.
Slovenian: Kreme ne nanašajte na tiste predele kože, ki so prizadeti zaradi aktivne virusne okužbe, kot sta herpes (herpes simpleks) ali vodene koze (norice).
English: • Open the tube (the first time you use the tube you will need to break the seal using the spike in the top of the cap).
Slovenian: (Pred prvo uporabo boste morali preluknjati zaščitno zaporko s konico, ki je na vrhu pokrovčka).
English: For excipients, see 6.1.
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: <Invented Name> may cause reactions at the application site such as a feeling of warmth and/or a burning sensation.
Slovenian: <Lastniško ime> lahko na mestu uporabe povzroča reakcije, kot sta občutek toplote in/ali pečenja.
English: <Invented Name> may be associated with an increased risk of a severe herpes simplex skin infection (eczema herpeticum).
Slovenian: <Lastniško ime> je lahko povezan z zvečano nevarnostjo hude okužbe kože z virusom herpes simpleks (herpetični ekcem).
English: The No Observed Adverse Effect Level (NOAEL) for female fertility was 10 mg/kg/day (= 20 times the maximum human exposure after dermal application).
Slovenian: Raven, pri kateri niso bili opaženi nikakršni neugodni učinki (NOAEL) za plodnost pri samicah, je bila 10 mg/kg/dan (= 20 kratna največja izpostavljenost pri človeku po uporabi na koži).
English: Prolonged systemic exposure to intense immunosuppression in transplant patients following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies.
Slovenian: Podaljšana sistemska izpostavljenost intenzivni imunosupresiji pri bolnikih po transplantaciji, ki so sistemsko prejemali inhibitorje kalcinevrina, je bila povezana s povečanim tveganjem za razvoj limfoma in kožnih malignih bolezni.
English: Douglan 1 % Creme 10 mg/ 1g Cream
Slovenian: Douglan 1 % Creme 10 mg/ 1g krema
English: There has been no experience of overdose with <Invented Name>.
Slovenian: Ni poročil o primerih prevelikega odmerjanja{Lastniško ime}.
English: If you use moisturisers, they should be applied immediately after <Invented Name> .
Slovenian: Če uporabljate sredstva za vlaženje kože, jih je treba nanašati takoj po nanosu <Lastniško ime>.
English: uncommon: furuncle, impetigo, herpes simplex, herpes zoster, herpes simplex dermatitis (eczema herpeticum), molluscum contagiosum, skin papilloma, application site disorders such as rash, pain, paraesthesia, desquamation, dryness, oedema, and condition aggravated.
Slovenian: Občasni: furunkel, impetigo, herpes simpleks, herpes zoster, herpes simpleks dermatitis (eczema herpeticum), molluscum contagiosum, kožni papilom, motnje na mestu uporabe, na primer izpuščaj, bolečine, parestezije, luščenje kože, suha koža, edem in poslabšanje bolezni.
English: Each affected region of the skin should be treated with <Invented Name> until clearance occurs and then treatment should be discontinued.
Slovenian: Vsak prizadeti predel kože zdravite z {Lastniško ime}, dokler se ne pozdravi, nato pa zdravljenje prekinite.
English: P.O.Box 241, 6800 LZ
Slovenian: P.O.Box 241,
English: <Invented Name> can be used in the short term for the treatment of the signs and symptoms of atopic eczema and intermittently in the long term for the prevention of progression to flares.
Slovenian: {Lastniško ime} se lahko uporablja kratkotrajno za zdravljenje znakov in simptomov atopijskega dermatitisa in intermitentno v daljšem obdobju za preprečevanje napredovanja do izbruhov bolezni (eksacerbacij).
English: • Apply only on areas affected with eczema
Slovenian: • Nanašajte samo na predele z ekcemom.
English: These reactions generally occurred early in treatment, were mild/moderate and were of short duration.
Slovenian: Te reakcije so se na splošno pojavljale na začetku zdravljenja, bile so blage do zmerne in prehodne.
English: Luxembourg Novartis Pharma GmbH Roonstraße 25
Slovenian: Luksemburg Novartis Pharma GmbH Roonstraße 25
English: Breastfeeding mothers may use <Invented Name> but should not apply <Invented Name> to the breast in order to avoid unintentional oral uptake by the newborn.
Slovenian: Doječe matere smejo uporabljati {Lastniško ime}, z izjemo na dojkah, da ne bi novorojenček nehote peroralno zaužil zdravila.
English: There is no experience with concomitant use of immunosuppressive therapies given for atopic eczema such as UVB, UVA, PUVA, azathioprine and cyclosporin A.
Slovenian: O sočasni uporabi imunosupresivnega zdravljenja atopijskega ekcema, na primer UVB, UVA, PUVA, azatioprina in ciklosporina A, ni na voljo nikakršnih izkušenj.
English: However, based on the minimal extent of pimecrolimus absorption after topical application of <Invented Name>, (see Section 5.2 “Pharmacokinetic properties”), the potential risk for humans is considered limited.
Slovenian: Vendar je zaradi minimalnega obsega absorpcije pimekrolimusa po lokalni uporabi {Lastniško ime} (glejte poglavje 5.2 “Farmakokinetične lastnosti”) mogoče sklepati, da je možno tveganje za ljudi omejeno.
English: The highest pimecrolimus blood concentration was 1.4 ng/ml in one patient.
Slovenian: Najvišja koncentracija pimekrolimusa v krvi, izmerjena pri enem bolniku, je bila 1,4 ng/ml.
English: However, since the relevance to man is unknown excessive exposure of the skin to ultraviolet light including light from a solarium, or therapy with PUVA, UVA or UVB should be avoided during treatment with <Invented Name>.
Slovenian: Kljub temu naj se bolniki med zdravljenjem z {Lastniško ime} izogibajo čezmernemu izpostavljanju kože ultravijolični svetlobi, na primer “sončenju” v solariju, in zdravljenju s PUVA, UVA in UVB, ker njihov vpliv na človeka ni znan.
English: Emollients can be applied together with <Invented Name> (see Section 4.2 “Posology and method of administration”).
Slovenian: 6.6 Navodila za uporabo in ravnanje z zdravilom Emolienti se lahko uporabljajo skupaj z {Lastniško ime} (glejte poglavje 4.2 “Odmerjanje in način uporabe”).
English: This may include intolerance to topical corticosteroids, lack of effect of topical corticosteroids and use on the face and neck where prolonged intermittent treatment with topical corticosteroids may be inappropriate”.
Slovenian: To lahko vključuje neprenašanje lokalnih kortikosteroidov, pomanjkljiv učinek lokalnih kortikosteroidov in uporabo na obrazu in vratu, kjer je dolgotrajno zdravljenje v presledkih z lokalno uporabljenimi kortikosteroidi lahko neprimerno".
English: <Invented Name> contains the active substance pimecrolimus, a calcineurin inhibitor.
Slovenian: {Lastniško ime} vsebuje zdravilno učinkovino pimekrolimus, inhibitor kalcinevrina.
English: NAME OF THE MEDICINAL PRODUCT <{(Invented) name strength pharmaceutical form}> <{(Invented) name and associated names (see Annex I) strength pharmaceutical form}> <[See Annex I - To be completed nationally]> [For referral procedures] Pimecrolimus
Slovenian: IME ZDRAVILA <Lastniško ime> 1% krema <{(Lastniško) ime in povezana imena (glejte Dodatek I) jakost farmacevtska oblika}> <[Glejte Dodatek I - Izpolni država članica]> pimekrolimus
English: Rizan 1 % cream 1 % Cream
Slovenian: Rizan 1 % cream 1 % krema
English: Before commencing treatment with <Invented Name>, clinical infections at treatment sites should be cleared.
Slovenian: Pred začetkom zdravljenja z {Lastniško ime} je treba pozdraviti klinične okužbe na prizadetih predelih.
English: No metabolism of pimecrolimus was observed in human skin in vitro.
Slovenian: In vitro ni bila v človeški koži ugotovljena nikakršna presnova zdravila.
English: In the long-term management of atopic dermatitis (eczema), <Invented Name> treatment should begin at first appearance of signs and symptoms of atopic dermatitis to prevent flares of the disease.
Slovenian: Pri dolgotrajnem zdravljenju atopijskega dermatitisa (ekcema) naj se za preprečitev izbruha bolezni zdravljenje z {Lastniško ime} začne pri prvem pojavu znakov in simptomov atopijskega dermatitisa.
English: Dose-dependent increases in the incidence of lymphomas were observed at all doses in a 39 week monkey oral toxicity study.
Slovenian: V 39-tedenski študiji peroralne toksičnosti pri opicah so opazili od odmerka odvisno povečanje incidence limfomov pri vseh odmerkih.
English: Always use <Invented Name> exactly as your doctor has instructed.
Slovenian: Pri uporabi kreme <Lastniško ime> vedno natančno upoštevajte zdravnikova navodila.
English: Systemic exposure is limited with the topical use of pimecrolimus.
Slovenian: Z lokalno uporabo pimekrolimusa se omeji sistemska izpostavitev.
English: Therefore pimecrolimus metabolism could not be determined after topical administration.
Slovenian: Zato presnove pimekrolimusa po lokalni uporabi ni bilo mogoče določiti.
English: Box 23490 Acropolis 1683 Lefkosia
Slovenian: Demetriades & Papaellinas Ltd 21 Kassou street P.O. Box 23490 Acropolis 1683 Lefkosia
English: NAME OF THE MEDICINAL PRODUCT <<Invented Name>>
Slovenian: Imetnik dovoljenja za promet z zdravilom Izmišljeno ime