FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee also concluded that the product information should include warnings regarding the potential risk of malignancies and reflect the second line use.
Slovenian: Odbor je poleg tega sklenil, da morajo podatki o zdravilu vključevati opozorila glede možnih tveganj za nastanek malignih obolenj in glede uporabe zdravila kot zdravila druge izbire.
English: Such reactions are generally mild/moderate, occur early in treatment and last only for a short time.
Slovenian: Take reakcije so na splošno blage/zmerne, pojavijo se zgodaj v poteku zdravljenja in trajajo le kratek čas.
English: The systemic exposure at the LOAEL of 15mg/kg/day was 31 times the highest maximum exposure observed in a human (paediatric patient).
Slovenian: Sistemska izpostavljenost koncentraciji LOAEL 15 mg/kg/dan je bila 31 krat večja od najvišje izpostavljenost pri človeku nasploh (pri pediatričnem bolniku).
English: - rare: alcohol intolerance ( in most cases, flushing, rash, burning, itching or swelling occurred shortly after the intake of alcohol), allergic skin reactions (e.g.dermatitis, urticaria).
Slovenian: Redki: alkoholna intoleranca (pri večini primerov so se rdečica, izpuščaj, pečenje, srbenje ali otekanje pojavili v kratkem času po zaužitju alkohola), alergijske kožne reakcije (npr. dermatitis, urtikarija).
English: <Invented Name> should be used for as short period as possible during flares of disease.
Slovenian: Trajanje uporabe {Lastniško ime} v času izbruha bolezni naj bo kar najkrajše.
English: Two double-blind studies of long-term management of atopic dermatitis were undertaken in 713 children and adolescents (2-17 years) and 251 infants (3-23 months).
Slovenian: V dveh dvojno slepih raziskavah dolgotrajnega zdravljenja atopijskega dermatitisa pri 713 otrocih in mladostnikih (2-17 let) in 251 dojenčkih (3-23 mesecev) je bil {Lastniško ime} ocenjen kot utemeljeno zdravljenje.
English: Laboratório Normal - Produtos Farmacêuticos, S.A Rua do Centro Empresarial, Edifício 8
Slovenian: Portugalska Laboratório Normal - Produtos Farmacêuticos, S.A Rua do Centro Empresarial,
English: You can use <Invented Name> on all skin areas, including the head, face and neck and in the folds of the skin.
Slovenian: <Lastniško ime> lahko uporabljate na vseh predelih kože, tudi na glavi, po obrazu in v kožnih pregibih.
English: If you accidentally swallow some <Invented Name> If you or someone else accidentally swallows <Invented Name> , tell your doctor immediately.
Slovenian: Če nehote zaužijete nekaj kreme <Lastniško ime> Če vi ali kdo drug nehote zaužije <Lastniško ime>, takoj obvestite zdravnika.
English: Also speak to your doctor before using <Invented Name> if you have any skin malignancies (tumours) or if you have a weakened immune system (immuno-compromised) whatever the cause.
Slovenian: Prav tako se pred uporabo <Lastniško ime> posvetujte z zdravnikom v primeru, da imate na koži malignom (kožnega raka) ali oslabljen imunski sistem iz kateregakoli razloga (ste imunokompromitirani).
English: Therefore, in patients with extensive disease, it is recommended to administer vaccinations during treatment-free intervals.
Slovenian: Zato je pri bolnikih z obsežno boleznijo priporočeno, da so cepljeni v obdobjih, ko se ne zdravijo z {Lastniško ime}.
English: The MAHs should submit 6-monthly updates to the RMS on the 10-year prospective observational cohort study to assess the risk of systemic cancer in paediatric patients.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo referenčni državi članici vsakih šest mesecev predložiti posodobitve desetletne prospektivne opazovalne kohortne študije za ocenitev tveganja za pojav sistemskega rakavega obolenja pri pediatričnih bolnikih.
English: Very common side-effects, reported in more than 1 in 10 people include: A feeling of warmth and/or burning at the application site.
Slovenian: Zelo pogosti neželeni učinki, o katerih poročajo pri več kot 1 od 10 ljudi, vključujejo: občutek toplote in/ali pečenja na mestu uporabe.
English: Some amendments of study designs have to be undertaken and further time is needed in order for pimecrolimus to be used by more subjects who can be observed for a sufficient length of time.
Slovenian: Sprejeti bi bilo treba nekatera dopolnila v zvezi z načrtovanjem raziskav, potrebno pa je tudi več časa, da začne pimekrolimus uporabljati večje število ljudi, ki bi jih lahko dovolj dolgo opazovali.
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORIZATION
Slovenian: DODATEK IV POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Studies in animals after oral application have shown reproductive toxicity (see Section 5.3 “Preclinical safety data”).
Slovenian: Študije na živalih po peroralnem dajanju zdravila so pokazale vpliv na razmnoževanje (glejte poglavje 5.3 “Predklinični podatki o varnosti”).
English: There was no increase in blood concentration over time in any patient during the 12 months of treatment.
Slovenian: Pri nobenem bolniku ni koncentracija v krvi v 12 mesečnem obdobju zdravljenja sčasoma naraščala.
English: Your doctor may ask you to stop using <Invented Name> until the infection has been adequately controlled.
Slovenian: Zdravnik vam bo morda svetoval, da prekinete z uporabo <Lastniško ime>, dokler se okužba ne pozdravi dovolj.
English: What <Invented Name> cream is and what it is used for Before you use <Invented Name> cream How to apply <Invented Name> cream Possible side effects
Slovenian: Kaj je zdravilo <Lastniško ime> krema in za kaj jo uporabljamo Kaj morate vedeti, preden boste uporabili kremo <Lastniško ime> Kako uporabljati kremo <Lastniško ime> Možni neželeni učinki
English: <Invented Name> Cream is for use only after other prescription medicines or emollients have not worked for you or if your Doctor recommends that other prescription medicines should not be used.
Slovenian: Kremo <Lastniško ime> se uporablja samo, če druga zdravila na recept ali negovalne kreme niso dovolj učinkovite ali če vam zdravnik odsvetuje uporabo drugih krem na recept.
English: If you are outdoors after applying <Invented Name> , wear loose fitting clothing, use appropriate sunscreen products and minimise the amount of time you spend in the sun.
Slovenian: Če boste po nanosu <Lastniško ime> na prostem, si oblecite ohlapna oblačila, uporabite primerno zaščitno kremo za sončenje in se kar najmanj zadržujte na soncu.
English: However, having reviewed the available data, the CHMP concluded that a potential association with the use of pimecrolimus could not be ruled out.
Slovenian: Vendar pa je po pregledu razpoložljivih podatkov zaključil, da možne povezave z uporabo pimekrolimusa ni mogoče izključiti.
English: If you forget an application of the cream, apply it as soon as possible and then continue your normal dosing routine.
Slovenian: Če ste pozabili uporabiti kremo <Lastniško ime> Če se pozabite namazati s kremo, jo nanesite čimprej in nato nadaljujte z običajnim urnikom uporabe.
English: Unlike corticosteroids, pimecrolimus does not cause skin atrophy in pigs and does not affect Langerhans´cells in murine skin.
Slovenian: Za razliko od kortikosteroidov pimekrolimus pri prašičih ne povzroča atrofije kože in ne vpliva na Langerhansove celice v koži miši.
English: Stop <Invented Name> as soon as signs of eczema have disappeared.
Slovenian: <Lastniško ime> prenehajte uporabljati takoj, ko znaki ekcema izginejo.
English: With regard to efficacy, pimecrolimus is less effective than the primary treatment for AD (topical corticosteroids).
Slovenian: Kar se tiče učinkovitosti, je pimekrolimus manj učinkovit od primarnega zdravljenja atopičnega dermatitisa (z lokalno uporabljenimi kortikosteroidi).
English: In the 5 children treated for 1 year, blood concentrations were consistently low (maximum blood concentration was 1.94 ng/ml in 1 patient).
Slovenian: Pri 5 otrocih, zdravljenih 1 leto, so bile koncentracije v krvi stalno nizke (najvišja izmerjena koncentracija v krvi je bila 1,94 ng/ml pri 1 bolniku).
English: Cases of tumours and herpes zoster should be kept under review and regular updates should be provided in the PSURs.
Slovenian: Primere tumorjev in herpesa zostra je treba preverjati, v rednih posodobljenih poročilih o varnosti pa morajo biti navedene redne posodobitve.
English: It works in the cells in the skin that cause the inflammation and characteristic redness and itching of eczema.
Slovenian: Deluje v celicah kože, ki povzročajo vnetje in za ekcem značilno rdečino in srbenje.
English: Failure to derive a NOAEL precludes an assessment of the margin of safety between a non-carcinogenic concentration in the monkey and exposures in patients.
Slovenian: Ker niso mogli ugotoviti NOAEL, niso mogli oceniti varnostne meje med ne-karcinogenimi koncentracijami pri opicah in izpostavljenostjo pri bolnikih.
English: WHAT <INVENTED NAME> CREAM IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO <LASTNIŠKO IME> KREMA IN ZA KAJ JO UPORABLJAMO
English: Istituto Farmaceutico S.p.A Via Umberto Boccioni, 1 21040 Origgio, Varese Italy
Slovenian: Istituto Farmaceutico S.p.A Via Umberto Boccioni, 1 21040 Origgio, Varese Italija
English: Keep the tube tightly closed.
Slovenian: Tuba naj bo ves čas dobro zaprta.
English: More patients treated with <Invented Name> completed 6 months [children (61% <Invented Name> vs 34% control), infants (70% <Invented Name> vs 33% control)] and 12 months with no flare [children (51% <Invented Name> vs 28% control), infants (57% <Invented Name> vs 28% control)].
Slovenian: Značilno več bolnikov, zdravljenih z {Lastniško ime}, je preživelo naslednjih 6 mesecev [(otroci {Lastniško ime} 61%, kontrole 34%); dojenčki ({Lastniško ime} 70%, kontrole 33%)] in 12 mesecev [(otroci: {Lastniško ime}51 %, kontrole 28%), dojenčki ({Lastniško ime} 57%, kontrole 28%)] brez izbruha.
English: Both <Invented Name> and topical corticosteroids were used without restrictions.
Slovenian: Tako {Lastniško ime} kot kortikosteroidi so bili uporabljani brez omejitev.
English: Distribution, Metabolism, and Excretion
Slovenian: Porazdelitev, presnova in izločanje
English: Apply a thin layer of <Invented Name> to the affected skin twice daily and rub in gently and completely.
Slovenian: Nanesite tanko plast {Lastniško ime} na prizadeto kožo dvakrat na dan in jo nežno in popolnoma vtrite vanjo.
English: Topical pimecrolimus penetrates similarly into, but permeates much less through human skin than corticosteroids, indicating a very low potential of pimecrolimus for systemic absorption.
Slovenian: Lokalni pimekrolimus podobno prodira v kožo kot kortikosteroidi, vendar ga mnogo manj preide skozi, kar kaže na zelo majhno verjetnost za sistemsko absorpcijo pimekrolimusa.
English: • A statement that pimecrolimus cream should not be used in children under 2 years.
Slovenian: Opozorilo, da se pimekrolimus v kremi ne sme uporabljati pri otrocih, mlajših od dveh let.
English: Care should be taken to avoid contact with eyes and mucous membranes.
Slovenian: Skrbno je treba paziti, da ne pride do stika zdravila z očmi in sluznicami.
English: If accidentally applied to these areas, the cream should be thoroughly wiped off and/or rinsed with water.
Slovenian: Če kremo nehote nanesete na te predele, jo morate temeljito obrisati in/ali sprati z vodo.
English: Data in animals
Slovenian: Podatki na živalih
English: The MAHs should report on the results of all planned mechanistic studies, as part of the Risk Management Plan.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo kot del načrta za obvladovanje tveganj poročati o rezultatih vseh načrtovanih mehanističnih študij.
English: Use of <Invented Name> may cause mild and transient reactions at the site of application, such as a feeling of warmth and/or burning sensation.
Slovenian: Uporaba {Lastniško ime} lahko povzroči blage in prehodne reakcije na mestu uporabe, na primer občutek toplote in/ali (občutek) pečenja.
English: As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summaries of Product Characteristics and Package Leaflets are set out in Annex III.
Slovenian: V skladu s tem je CHMP priporočil ohranitev dovoljenja za promet z zdravili, ki so navedena v Dodatku I in za katera so v Dodatku III podrobno predstavljene dopolnitve ustreznih točk v Povzetkih glavnih značilnosti zdravila in Navodilih za uporabo.
English: Novartis Finland Oy, Metsänneidonkuja 10, 02130 Espoo, Finland
Slovenian: Novartis Finland Oy, Metsänneidonkuja 10, 02130 Espoo, Finska
English: * Investigators Global Assessment ° Eczema Area Severity Index (EASI): mean % change in clinical signs (erythema, infiltration, excoriation, lichenification) and body surface area involved
Slovenian: ° Indeks prizadetosti ekcemskega predela (Eczema Area Severity Index) (EASI) : pomeni spremembo kliničnih znakov v % (eritem, infiltracija, ekskoriacija, lihenifikacija) in prizadeti predel telesne površine.
English: It is not known whether pimecrolimus is excreted in the milk after topical application.
Slovenian: Ni znano, ali se pimekrolimus po lokalni uporabi izloča v mleko.
English: The MAHs will set up an independent Data Safety Monitoring Board (DSMB) to assess the safety of pimecrolimus every 6 months based on all the available safety information from clinical trials, pharmacoepidemiology and post-marketing surveillance data.
Slovenian: Imetniki dovoljenja za promet z zdravilom bodo osnovali neodvisen odbor za spremljanje podatkov o varnosti (Data Safety Monitoring Board, DSMB) za ocenitev varnosti uporabe pimekrolimusa vsakih šest mesecev na temelju vseh razpoložljivih varnostnih podatkov, pridobljenih v kliničnih preskušanjih, farmakoepidemioloških raziskavah in podatkov, pridobljenih s postmarketinškim spremljanjem.
English: While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi's varicelliform eruption), treatment with <Invented Name> may be associated with an increased risk of skin herpes simplex virus infection, or eczema herpeticum (manifesting as rapid spread of vesicular and erosive lesions).
Slovenian: Ker so bolniki z atopijskim dermatitisom dovzetni za površinske okužbe kože, med drugim za eczema herpeticum (Kaposijeva variceliformna erupcija), utegne biti zdravljenje z {Lastniško ime} povezano s povečanim tveganjem kožne okužbe z virusom herpesa simpleksa ali eczema herpeticum (ki se kaže kot hitro širjenje vezikularnih in erozivnih lezij).
English: Both topical corticosteroids induced a significant reduction in skin thickness measured by echography, as compared to <Invented Name> and vehicle, which did not induce a reduction of skin thickness.
Slovenian: Oba lokalna kortikosteroida sta povzročila značilno stanjšanje kože, merjeno z ehografijo, v primerjavi z {Lastniško ime} in vehiklom, ki nista povzročila tanjšanja kože.
English: The MAHs should re-run the lymphoma study in 2009 and report the results to the RMS.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo limfomsko študijo ponovno opraviti leta 2009, rezultate pa sporočiti referenčni državi članici.
English: If your skin becomes infected during treatment with <Invented Name> , you should inform your doctor.
Slovenian: Če pride do okužbe kože med zdravljenjem z <Lastniško ime>, morate na to opozoriti zdravnika.
English: Due to the potential for increased systemic absorption of pimecrolimus, <Invented Name> is not recommended in patients with Netherton's syndrome.
Slovenian: Zaradi možnosti povečane sistemske absorpcije pimekrolimusa {Lastniško ime} pri bolnikih z Nethertonovim sindromom ni priporočen.
English: In 8 adult atopic dermatitis patients, in which AUC levels could be quantified, the AUC (0-12h) values ranged from 2.5 to 11.4 ng h/ml.
Slovenian: Pri 8 odraslih bolnikih z atopijskim dermatitisom, pri katerih je bilo možno izračunati AUC, so vrednosti AUC(0-12h) segale od 2,5 do 11,4 ng h/ml.
English: Adults: <Invented Name> was less effective than 0.1% betamethasone-17-valerate in the short-term treatment (3 weeks) of adults with moderate to severe atopic dermatitis.
Slovenian: Odrasli: {Lastniško ime} je bil manj učinkovit kot 0,1% betametazon-17-valerat pri kratkotrajnem zdravljenju (3 tedne) odraslih z zmernim do hudim atopičnim dermatitisom.
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: • A statement to highlight that pimecrolimus should not be applied to lesions, which are considered to be potentially malignant or pre-malignant.
Slovenian: Opozorilo, v katerem je poudarjeno, da se pimekrolimusa ne sme nanašati na lezije, za katere se ocenjuje, da bi utegnile biti maligne ali predmaligne.
English: Pimecrolimus is a lipophilic anti-inflammatory ascomycin macrolactam derivative and a cell selective inhibitor of the production and release of pro-inflammatory cytokines.
Slovenian: Pimekrolimus je lipofilni protivnetni makrolaktamski derivat askomicina in celično selektiven zaviralec nastajanja in sproščanja citokinov, ki pospešujejo vnetje.
English: As a consequence, it blocks the synthesis of inflammatory cytokines in T cells.
Slovenian: Zato zavira sintezo vnetnih citokinov v limfocitih T.
English: Novartis Pharma B.V., Arnhem,
Slovenian: Nizozemska Novartis Pharma B.V., Arnhem,
English: Therefore, the CHMP recommended the restriction of the therapeutic indications to these patients where treatment with topical corticosteroids is either inadvisable or not possible.
Slovenian: Zato je CHMP priporočil omejitev terapevtskih indikacij na tiste bolnike, pri katerih zdravljenje z lokalnimi kortikosteroidi bodisi ni priporočljivo bodisi ni mogoče.
English: INSTRUCTIONS ON USE Apply a thin layer of <Invented Name> and completely cover the affected skin.
Slovenian: NAVODILA ZA UPORABO Nanesite tanko plast <Lastniško ime> in popolnoma prekrijte prizadeto kožo.
English: <Invented Name> should be used twice daily.
Slovenian: {Lastniško ime} je treba uporabljati dvakrat na dan.
English: Pimecrolimus neither impairs the primary immune response nor affects lymph nodes in murine allergic contact dermatitis.
Slovenian: Pimekrolimus pri miših ne zavira primarnega imunskega odziva niti ne vpliva na bezgavke pri alergijskem kontaktnem dermatitisu.
English: In the long-term treatment of eczema, begin using <Invented Name> as soon as you notice signs and symptoms (redness and itch).
Slovenian: Pri dolgotrajnem zdravljenju ekcema, začnite uporabljati <Lastniško ime> takoj, ko opazite znake in simptome (rdečino in srbenje).
English: Based on its minimal extent of absorption, interactions of <Invented Name> with systemically administered medicinal products are unlikely to occur (see Section 5.2 “Pharmacokinetic properties”).
Slovenian: Zaradi minimalnega obsega njegove absorpcije medsebojno delovanje med {Lastniško ime} in sistemskimi zdravili ni verjetno (glejte poglavje 5.2 “Farmakokinetične lastnosti”).
English: • Apply a thin layer of <Invented Name> and completely cover the affected skin.
Slovenian: • Nanesite tanko plast <Lastniško ime> in povsem prekrijte prizadeto kožo.
English: <Invented Name> cream should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that causes immunosuppression.
Slovenian: Kreme {Lastniško ime} se ne sme uporabljati pri bolnikih s prirojeno ali pridobljeno imunsko pomanjkljivostjo ali pri bolnikih, ki prejemajo imunosupresivno terapijo.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
English: Conventional studies of repeated dose toxicity, reproductive toxicity and carcinogenicity using oral administration produced effects at exposures sufficiently in excess of those in man to be of negligible clinical significance.
Slovenian: Standardne raziskave toksičnosti ponavljajočih se odmerkov, vpliva na sposobnost razmnoževanja in kancerogenosti peroralno dajanega zdravila so povzročale učinke pri izpostavljenostih, ki so toliko večje od tistih pri človeku, da imajo zanemarljiv klinični pomen.
English: A maximum blood concentration of 0.8 ng/ml was measured in only 2 patients in week 6 of treatment.
Slovenian: Najvišja krvna koncentracija 0,8 ng/ml je bila izmerjena samo pri 2 bolnikih med 6. tednom zdravljenja.
English: Parent compound was not detected in urine and less than 1% of radioactivity in faeces was accounted for by unchanged pimecrolimus.
Slovenian: Izhodne spojine v urinu niso bile zaznane, nespremenjeni pimekrolimus pa je predstavljal manj kot 1% radioaktivnosti v blatu.
English: If you have extensive eczema, treatment with <Invented Name> may have to be stopped before any vaccinations.
Slovenian: Če imate obsežen ekcem, bo morda pred cepljenjem potrebno prekiniti zdravljenje z <Lastniško ime>.
English: The MAH has already put in place a safety-monitoring plan to further evaluate the long-term safety of pimecrolimus, including a registry in paediatric patients.
Slovenian: Imetnik dovoljenja za promet z zdravilom je pripravil načrt spremljanja varnosti uporabe, da bi še dodatno ovrednotil varnost dolgotrajne uporabe pimekrolimusa, vključno z registrom za pediatrične bolnike.
English: Once opened, the tube should be used within 12 months.
Slovenian: Tubo je treba porabiti v 12 mesecih od takrat, ko jo prvič odprete.
English: Patients were treated twice daily with <Invented Name>.
Slovenian: Bolniki so bili zdravljeni z {Lastniško ime} dvakrat na dan.
English: Novartis Finland Oy Metsänneidonkuja 10 FI - 02130 Espoo Finland
Slovenian: Novartis Finland Oy Metsänneidonkuja 10 FI - 02130 Espoo Finska
English: <Invented Name> had a sparing effect on the use of topical corticosteroids: more patients treated with <Invented Name> did not use corticosteroids in 12 months [children (57% <Invented Name> vs 32% control), infants (64% <Invented Name> vs 35% control)].
Slovenian: Ob uporabi {Lastniško ime} je bila potreba po zdravljenju z lokalnimi kortikosteroidi manjša: več bolnikov, zdravljenih z {Lastniško ime}, ni uporabljalo kortikosteroidov v 12 mesecih [otroci (57% {Lastniško ime} proti 32% kontrole), dojenčki (64% {Lastniško ime} proti 35% kontrole)].
English: The MAHs should provide a re-analysis of the data of this case-control study to estimate the risk of non-melanoma skin cancer.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo poskrbeti za ponovno analizo podatkov, pridobljenih v tej kontrolni študiji, da bi ocenili tveganje za pojav nemelanomskega kožnega raka.
English: • Pimecrolimus cream should not be used in immunocompromised adults or children.
Slovenian: Pimekrolimus v kremi se ne sme uporabljati pri odraslih ali otrocih z oslabljenim imunskim sistemom.
English: The atrophogenic potential of <Invented Name> in humans was tested in comparison to medium and highly potent topical steroids (betamethasone-17-valerate 0.1% cream, triamcinolone acetonide 0.1% cream) and vehicle in sixteen healthy volunteers treated for 4 weeks.
Slovenian: Atrofogeni potencial {Lastniško ime} pri ljudeh je bil preizkušen v primerjavi s srednje močnimi in zelo močnimi lokalnimi steroidi (0,1%-na krema betametazon-17-valerata, 0,1%-na krema triamcinolonacetonida) in z vehiklom pri šestnajstih zdravih prostovoljcih, zdravljenih 4 tedne.
English: If you have any questions or are unsure about anything regarding your medicine please ask your doctor or pharmacist.
Slovenian: Če imate kakršnakoli vprašanja ali ste v kakršnemkoli dvomu glede zdravila, se lahko posvetujete s svojim zdravnikom ali farmacevtom.