natgillin/translations-raw huggingface dataset:
Substances that affect the Hedgehog pathway can result in serious harm to an unborn baby.
Snovi, ki vplivajo na signalno pot Hedgehog, lahko resno poškodujejo nerojenega otroka, zato morajo ženske, ki jemljejo zdravilo Odomzo, med zdravljenjem in 20 mesecev po njegovi prekinitvi upoštevati učinkovite ukrepe za preprečevanje nosečnosti.
Subcutaneos use
Subkutana uporaba
Vial (glass)
Viala (steklo)
Strength Pharmaceutical Form Route of Administration
Izmišljeno ime Jakost farmacevtska oblika pot uporabe
1 bottle + 1 oral syringe + 1 press-in bottle adapter
1 plastenka + 1 brizga za peroralno dajanje + 1 nastavek za plastenko
10 mg/ml
10 mg/ml prašek za peroralno suspenzijo peroralna uporaba plastenka (HDPE)
However, you can still wear normal clothing.
Seveda pa se lahko normalno oblečete.
• Wash and dry your hands.
• Umijte in obrišite si roke.
Your doctor will be able to tell you if this is necessary.
Vaš zdravnik vam po povedal, če bo to potrebno.
The first report will be provided in 2007 and this requirement will be reevaluated on a regular basis.
Prvo poročilo bo pripravljeno leta 2007, ta zahteva pa se bo redno preverjala.
Do not use it in your nose, eyes or mouth.
Ne nanašajte je v nos, oči ali usta.
Whitish and homogeneous.
Belkasta in homogena.
{Name and Address} <{tel}> <{fax}> <{e-mail}>
{Ime in naslov} <{tel.}> <{fax}> <{e-mail}>
It does not contain any steroids.
Ne vsebuje nobenih steroidov.
The cream should be applied twice daily, for instance once in the morning and once in the evening.
Kremo je treba nanašati dvakrat dnevno, na primer enkrat zjutraj in enkrat zvečer.
Improvement 2
Izboljšanje 2
Therefore it should not be used in this age group.
Pri tej starostni skupini se je torej ne sme uporabljati.
Independent DSMB
Neodvisni DSMB
Frequency of application greater than twice daily has not been studied.
Pogostnost uporabe, večje od dvakrat na dan, ni bila proučena.
In general, these data are not conclusive and the studies have weaknesses which limit their interpretation.
V splošnem ti podatki niso prepričljivi, študije pa vsebujejo šibke točke, ki omejujejo interpretacijo teh podatkov.
Risk Management Plan
Načrt za obvladovanje tveganj
Registry Study (C2311)
Registrska študija (C2311)
Study C2308
Študija C2308
Therefore, Annex III may not necessarily represent the current text.
Dodatek III torej ne predstavlja nujno najnovejše različice besedila.
After first opening the container: 12 months.
Po prvem odpiranju tube: 12 mesecev.
Carefully follow all instructions given to you by your doctor.
Skrbno se ravnajte po navodilih, ki vam jih je dal vaš zdravnik.
In these three 6-week studies, the efficacy results at endpoint were as follows:
Pri vseh treh šesttedenskih raziskavah je bila končna učinkovitost sledeča:
The data of both studies were pooled.
Podatki iz obeh raziskav so bili združeni.
Occlusive dressings are not recommended.
Okluzivni zavoji niso priporočeni.
The main reasons include too short lengths of exposure, too short durations of follow-up and methodological shortcomings.
Glavni razlogi zajemajo prekratek čas izpostavitve, prekratko trajanje spremljanja in pa metodološke pomanjkljivosti.
Short-term (acute) treatment:
Kratkotrajno (akutno) zdravljenje
59.9% 33% not done
59,9% 33% Ni bila izračuna -na.
This will be re-evaluated on a regular basis.
To se bo redno preverjalo.
The affected BSA ranged from 10-92%.
Prizadeta BSA je bila od 10-92%.
Sintra Portugal
Sintra Portugalska
Interactions with other medicines that you take are unlikely to occur.
Medsebojno delovanje z drugimi zdravili, ki jih jemljete, je malo verjetno.
Clear or almost clear 1
Ozdravljen ali skoraj ozdravljen 1
A significant improvement in pruritus was observed within the first week of treatment in 44% of children and adolescents and in 70% of infants.
Značilno izboljšanje pruritusa je bilo opaženo v prvem tednu zdravljenja pri 44% otrok in mladostnikov ter pri 70% dojenčkov.
Long-term clinical trials were 1 year in duration.
Dolgotrajna klinična preskušanja so trajala 1 leto.
• Squeeze the cream onto your finger.
• Iztisnite nekaj kreme na prst.
If signs and symptoms return you should start treatment again.
Če se znaki in simptomi ponovijo, ponovno začnite z zdravljenjem.
Do not use for other skin conditions.
Ne uporabljajte je za druge spremembe na koži.
68% 40% Not done
68% 40% Ni bila izračunana.
PHARMACEUTICAL FORM Cream.
FARMACEVTSKA OBLIKA Krema.
After the Commission Decision, the Member State competent authorities will update Annex III as required.
Po odločbi Komisije bodo pristojne oblasti držav članic Dodatek III posodobile v skladu z zahtevami.
Frequency estimates: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000, including isolated reports).
Ocene pogostnosti: zelo pogosti (≥1/10); pogosti(≥1/100, <1/10); občasni (≥1/1,000, <1/100); redki(≥1/10,000, <1/1,000); zelo redki (<1/10.000, vključno s posameznimi poročili).
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING PIMECROLIMUS (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENE OCENE ZDRAVIL, KI VSEBUJEJO PIMEKROLIMUS (glejte Dodatek I)
Total mean recovery of radioactivity was 80.9%.
Celotni povprečni prestrezek radioaktivnosti je bil 80,9%.
Continue using the cream for as long as your doctor advises.
Z uporabo kreme nadaljujte tako dolgo, kot vam svetuje zdravnik.
However a local immunosuppressive effect in the skin cannot be excluded.
Kljub temu pa lokalnega imunosupresivnega učinka v koži ni mogoče izključiti.
Tubes of 15, 30, 60 and 100 grams.
Tube s 15, 30, 60 in 100 grami.
You should take care not to swallow it, or to accidentally transfer it into your mouth when for example it is applied to the hands.
Pazite, da kreme ne bi zaužili ali je nehote prenesli v usta, kadar jo naprimer nanašate na roke.
Half of the patients in the control group received topical corticosteroids for more than 95% of study days.
Polovica bolnikov v kontrolni skupini je dobivala lokalne kortikosteroide več kot 95% dni raziskave.
Pharmacological/Mechanistic Studies
Farmakološke/Mehanistične študije
The malignancies reported were very diverse in their origin and location.
Maligna obolenja, o katerih so poročali, so bila po svojem izvoru in mestu pojavljanja zelo različna.
DK-2100 København Ø, Denmark
DK-2100 København Ø, Danska
This helps to prevent progression to severe flare-ups.
To pomaga preprečevati napredovanje bolezni do hudih izbruhov.
This is reflected by the findings from the fertility study.
To odsevajo rezultati raziskave plodnosti.
This should encompass all age groups including those aged <2 years.
V to morajo biti vključene vse starostne skupine, vključno s tistimi, katerih starost znaša manj kot dve leti.
For children (2-11 years) and adolescents (12-17 years) the posology and method of administration are the same as for adults.
Pri otrocih (2-11 let) in mladostnikih (12-17 let) so priporočila za odmerjanje in način uporabe enaka kot pri odraslih.
This could wash off the cream.
S tem bi kremo lahko sprali s kože.
Pimecrolimus is exclusively metabolised by CYP 450 3A4.
Pimekrolimus presnavlja izključno CYP 450 3A4.
In accordance with the “Guideline on risk management systems for medicinal products for human use (EMEA/CHMP/96268/2005)”, the MAHs should provide a full Risk Management Plan to the RMS.
Skladno s "Smernicami za sisteme obvladovanja tveganj v zvezi z zdravili za uporabo v humani medicini (EMEA/CHMP/96268/2005)", morajo imetniki dovoljenja za promet z zdravilom referenčni državi članici zagotoviti celovit načrt za obvladovanje tveganj.
In patients with severely inflamed and/or damaged skin, the systemic concentrations may be higher.
Pri bolnikih s hudo vneto in/ali poškodovano kožo pride lahko do večjih sistemskih koncentracij.
Apply the cream as follows:
Kremo uporabljajte takole:
Special studies
Posebne raziskave
They were in a range similar to that measured in adult patients.
Po razponu so bile podobne koncentracijam, izmerjenim pri odraslih bolnikih.
A Dear Healthcare professional letter should be sent to relevant Healthcare professionals on 3 April
Pismo z naslovom Spoštovani zdravnik je treba zadevnim zdravnikom poslati 3. aprila 2006.
Overall (mean % change)3
Na splošno (povprečna sprememba v %)3
Pharmacotherapeutic group: Other dermatologicals, ATC code: D11AX15
Farmakoterapevtska skupina: druga dermatološka zdravila, Oznaka ATC: D11AX15
Therefore the CHMP requested that the MAH should take the appropriate measures in order to ensure that Elidel is not used in this age group.
Zato je CHMP zahteval, da mora imetnik dovoljenja za promet z zdravilom sprejeti ustrezne ukrepe, s katerimi bi zagotovil, da se Elidel ne bo uporabljal pri tej starostni skupini.
The timelines will depend on the scope of the re-analysis, which will be clarified with the RMS.
Časovni roki bodo odvisni od obsega ponovne analize, kar bo podrobneje pojasnila referenčna država članica.
1: p-value based on CMH test stratified by centre
1: Vrednost p temelji na testu CMH, stratificiranem po centrih.
Novartis Norge AS Postboks 237 Økern 0510 Oslo Norway
Novartis Norge AS Postboks 237 Økern 0510 Oslo Norveška
Atopic dermatitis (eczema) is rarely observed in patients aged 65 and over.
Atopijski dermatitis (ekcem) je redko opažen pri bolnikih, starih 65 let in več.
Novartis Hungária Kft. Pharma 1114 Budapest, Bartók Béla út 43-47.
Madžarska Novartis Hungária Kft. Pharma 1114 Budapest, Bartók Béla út 43-47.
Pimecrolimus had no genotoxic, antigenic, phototoxic, photoallergenic or photocarcinogenic potential.
Pimekrolimus nima genotoksičnega, antigenskega, fototoksičnega, fotoalergenskega in fotokancerogenega potenciala.
Please consult your doctor.
O tem se posvetujte s svojim zdravnikom.
The efficacy and safety profile of <Invented Name> has been evaluated in more than 2,000 patients including infants (≥3 months), children, adolescents, and adults enrolled in phase II and III studies.
Profil učinkovitosti in varnosti {Lastniško ime} je bil ocenjen na več kot 2000 bolnikih, tudi dojenčkih (≥3 mesece), otrocih, mladostnikih in odraslih, vključenih v raziskave druge in tretje faze.
- The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing topical pimecrolimus.
Ker je Odbor obravnaval napotitev s skladu s členom 31 Direktive 2001/83/ES, s spremembami, za zdravila, ki vsebujejo lokalni pimekrolimus.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed by a doctor.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
The affected body surface area (BSA) ranged from 15-59%.
Telesna površina (BSA) je bila 15-59%.
The use of <Invented Name> in patients under 2 years of age is not recommended until further data become available.
Uporaba {Lastniško ime} pri bolnikih, mlajših od 2 let, ni priporočljiva, dokler ne bodo na voljo nadaljnji podatki.
The maximum body surface area treated was 92% in clinical pharmacology studies and up to 100% in Phase III trials.
Največja zdravljena telesna površina je bila 92% v kliničnofarmakoloških raziskavah in do 100% v preizkusih III faze.
Absorption in adults
Absorpcija pri odraslih
Over 1,500 of these patients were treated with <Invented Name> and over 500 were treated with control treatment i.e. either <Invented Name> vehicle and/or topical corticosteroids.
Več kot 1500 teh bolnikov je bilo zdravljenih z {Lastniško ime} in več kot 500 jih je bilo tretiranih s kontrolnim zdravljenjem, tj. z vehiklom {Lastniško ime} in/ali z lokalnimi kortikosteroidi.
Pimecrolimus blood concentrations were consistently low regardless of the extent of lesions treated or duration of therapy.
Koncentracije pimekrolimusa v krvi so bile stalno nizke, ne glede na obseg zdravljenih lezij ali trajanje zdravljenja.
Novartis Pharma 2-4, rue Lionel Terray 92500 Rueil-Malmaison France
Novartis Pharma 2-4, rue Lionel Terray 92500 Rueil-Malmaison Francija
If you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.
Če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
If you have erythroderma (redness of almost the entire body) or a skin condition called Netherton's syndrome, speak to your doctor before you start using <Invented Name> .
Če imate eritrodermijo (rdečo kožo po skoraj celem telesu) ali kožno bolezen, ki se imenuje Nethertonov sindrom, se posvetujte z zdravnikom preden začnete uporabljati <Lastniško ime>.
Clinical studies with <Invented Name> did not include a sufficient number of patients in this age range to determine whether they respond differently from younger patients.
Klinične raziskave z {Lastniško ime} niso zajele dovolj bolnikov iz te starostne skupine, da bi bilo lahko ugotovljeno, ali se odzivajo drugače od mlajših bolnikov.
The most common adverse events were application site reactions which were reported by approximately 19% of the patients treated with <Invented Name> and 16% of patients in the control groups.
Najpogostejši neželeni učinki so reakcije na mestu uporabe, o katerih je bilo poročano pri približno 19% bolnikov, zdravljenih z {Lastniško ime}, in pri 16% bolnikov v kontrolni skupini.
The diagnosis of atopic dermatitis should be re-evaluated and further therapeutic options considered.
Diagnozo atopijskega dermatitisa je treba ponovno pretehtati in razmisliti o nadaljnjih možnostih zdravljenja.
The CHMP also expressed concerns about the degree of use of topical pimecrolimus in children under the age of 2 (not approved) when the immune system is still developing.
CHMP je tudi izrazil zaskrbljenost glede razširjenosti lokalne uporabe pimekrolimusa pri otrocih, starih manj kot dve leti (uporaba ni odobrena), ko se imunski sistem še vedno razvija.
Note: This Annex III (Summary of Product Characteristics, Labelling and Package Leaflet) is the one that was Annexed to the Commission Decision on this Article 31 referral for pimecrolimus containing medicinal products.
Opomba: Ta Dodatek III (Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo) je bil priložen k odločbi Komisije o napotitvenem postopku iz člena 31 za zdravila, ki vsebujejo pimekrolimus.
Active substance-related radioactivity was excreted principally via the faeces (78.4%) and only a small fraction (2.5%) was recovered in urine.
Z učinkovino povezana radioaktivnost se je izločala predvsem z blatom (78,4%) in le majhen delež (2,5%) je bil prestrežen v urinu.
Novartis (Hellas) AEBE 12km Athens-Lamia Metamorfosi GR-14451 Athens Greece
Novartis (Hellas) AEBE 12km Athens-Lamia Metamorfosi GR-14451 Athens Grčija
AUC ranges observed in patients with <40% BSA affected at baseline were comparable to those in patients with ≥40% BSA.
Razponi AUC pri bolnikih, ki so imeli v izhodišču prizadete <40% BSA, so bili primerljivi s tistimi pri bolnikih z ≥40% BSA.
The CHMP also considered the available data from clinical trials and epidemiological studies.
CHMP je preučil tudi razpoložljive podatke kliničnih preskušanj in epidemioloških študij.
Following this request, the CHMP reviewed data on efficacy and the available data on the mentioned safety issue, including post-marketing reports, data from non-clinical studies, clinical trials and epidemiological studies.
Na podlagi te prošnje je CHMP pregledal podatke o učinkovitosti in razpoložljive podatke, ki se nanašajo na omenjeno vprašanje varnosti, vključno s postmarketinškimi poročili, podatki iz nekliničnih raziskav, kliničnih preskušanj in epidemioloških študij.
In view of the available data (including pre-clinical, clinical and epidemiological) the CHMP concluded that a potential association with the use of pimecrolimus cannot be ruled out and therefore further data are needed to ensure an acceptable long term safety profile.
Glede na razpoložljive podatke (vključno s predkliničnimi, kliničnimi in epidemiološkimi), je CHMP zaključil, da potencialne povezave med temi obolenji in uporabo pimekrolimusa ni mogoče izključiti in da so torej potrebni dodatni podatki, ki bi zagotovili sprejemljiv varnostni profil pri dolgotrajni uporabi zdravila.
On the view of these results, the necessity for further studies should be rediscussed with the RMS.
Glede na dobljene rezultate se je treba o potrebi po dodatnih študijah ponovno pogovoriti z referenčno državo članico.
The efficacy of <Invented Name> was maintained over time.
Učinkovitost {Lastniško ime} se je s časom ohranjala.
Long-term effect on the local skin immune response and on the incidence of skin malignancies is unknown.
Dolgoročni učinek na lokalni kožni imunski odziv in na pogostnost kožnih malignih bolezni ni znan.
Infants: A similar 6-week study was conducted in 186 patients aged 3-23 months.
Dojenčki: Podobna šesttedenska raziskava je bila narejena na 186 bolnikih, starih 3-23 mesecev.
Animal studies using dermal application do not indicate direct or indirect harmful effects with respect to embryonal/fetal development.
Študije na živalih z uporabo na koži ne kažejo na neposredne ali posredne škodljive vplive na razvoj zarodka/plodu.
Data from clinical studies support intermittent treatment with <Invented Name> for up to 12 months.
Podatki iz kliničnih študij podpirajo intermitentno zdravljenje z {Lastniško ime}do 12 mesecev.
If the application site reaction is severe, the risk-benefit of treatment should be re-evaluated.
Če je lokalna reakcija zdravila resna, je treba oceniti razmerje med tveganjem in koristnostjo zdravljenja.
There are no adequate data from the use of <Invented Name> in pregnant women.
Ni zadostnih podatkov o uporabi {Lastniško ime} pri nosečnicah.
Vehicle (N=63)
Vehikel (N=63)
Systemic exposure to pimecrolimus was investigated in 58 paediatric patients aged 3 months to 14 years.
Sistemska izpostavljenost pimekrolimusu je bila raziskana pri 58 pediatričnih bolnikih, starih od 3 mesecev do 14 let.
Dermal application in embryo/fetal developmental studies in rats and rabbits and in carcinogenicity studies in mice and rats were negative.
Rezultati uporabe na koži v razvojnih raziskavah zarodkov in plodov pri podganah in kuncih in v raziskavah kancerogenosti pri miših in podganah so bili negativni.
If no improvement occurs after 6 weeks, or in case of disease exacerbation, <Invented Name> should be stopped.
Če v 6 tednih ne nastopi izboljšanje ali če bolezen eksacerbira, je treba {Lastniško ime} ukiniti.
very common: application site burning.
Zelo pogost: pečenje na mestu uporabe.
Absorption in children
Absorpcija pri otrocih
Vehicle (N=136)
Vehikel (N=136)
Children and adolescents: Two 6-week, vehicle-controlled trials were conducted including a total of 403 paediatric patients aged 2 to 17 years.
Otroci in mladostniki: Narejeni sta bili dve šesttedenski, z vehiklom kontrolirani raziskavi, ki sta zajeli 403 pediatričnih bolnikov, starih od 2 do 17 let.
The most common side effects of <Invented Name> are reactions (e.g. discomfort) at the application site.
Najbolj pogosti neželeni učinki <Lastniško ime> so reakcije (npr. neprijeten občutek) na mestu uporabe.
<Invented Name> should not be applied under occlusion (see Section 4.4 “Special warnings and precautions for use”).
{Lastniško ime} se ne sme uporabljati pod okluzivnim zavojem (glejte poglavje 4.4 “Posebna opozorila in previdnostni ukrepi”).
These reactions are usually mild and last only for a short time.
Te reakcije so običajno blage in trajajo le kratek čas.
Tell your doctor before starting treatment with <Invented Name> if you are pregnant or think that you may be pregnant.
Preden začnete zdravljenje z <Lastniško ime>, povejte zdravniku, če ste noseči ali menite, da bi lahko bili.
As the safety of <Invented Name> has not been established in erythrodermic patients, the use of the product in this patient population cannot be recommended.
Ker varnost {Lastniško ime} pri bolnikih z eritrodermijo ni bila dokazana, uporabe zdravila v tej skupini bolnikov ne moremo priporočati.
Signs of recovery and/or at least partial reversibility of the effects were noted upon cessation of dosages in a few animals.
Pri nekaterih živalih so opazili znake okrevanja in/ali vsaj delne reverzibilnosti učinkov po prenehanju dajanja zdravila.
Topical corticosteroid medication was used on 14.2 ± 24.2% of the days of the 24-week treatment period in <Invented Name> group and on 37.2 ± 34.6% of the days in the control group (p<0.001).
V skupini z {Lastniško ime} je bilo uporabljeno lokalno kortikosteroidno zdravljenje na 14,2 ± 24,2% dni 24-tedenskega zdravljenja, v kontrolni skupini pa na 37,2 ± 34,6% dni (p<0,001).
A 6-month randomized, double-blind, parallel group, vehicle-controlled study of similar design was performed in 192 adults with moderate to severe atopic dermatitis.
Podobno zasnovana 6-mesečna randomizirana, dvojno slepa, z vehiklom kontrolirana raziskava na paralelni skupini je bila opravljena na 192 odraslih z zmernim do težkim atopijskim dermatitisom.
The bioavailability of pimecrolimus in mini-pigs following a single dermal dose (applied for 22h under semi-occlusion) was 0.03%.
Biološka uporabnost pimekrolimusa pri prašičkih po enem kožnem odmerku (danem za 22 ur pod semi-okluzijo) je bila 0,03%.
3: p-value based on ANCOVA model of EASI at Day 43 endpoint, with centre and treatment as factors and baseline (Day 1) EASI a covariate;
3: Vrednost p temelji na modelu ANCOVA EASI(-ja) glede na končno stanje na 43. dan, pri čemer sta center in zdravljenje faktorja, izhodiščni EASI (na 1. dan) pa kovariabla.
If your skin is infected, your doctor may ask you to use an appropriate medicine to treat the infection.
Če imate na koži okužbo, vam bo zdravnik svetoval ustrezno zdravilo za zdravljenje okužbe.
You may find it helpful to write the date you opened the tube in the space provided on the carton.
Morda vam bo prišlo prav, če boste datum prve uporabe zapisali na za to predviden prostor na škatli.
The DSMB will be composed of independent physicians with expertise in Dermatology, Pediatric Medicine, Immunology, Epidemiology and Oncology.
Odbor za spremljanje podatkov o varnosti bodo sestavljali neodvisni zdravniki s specializacijo iz dermatologije, pediatrije, imunologije, epidemiologije in onkologije.
These children were treated with <Invented Name> twice daily for 3 weeks and five out of them were treated for up to 1 year on a “as needed” basis.
Večina otrok je bila zdravljena z {Lastniško ime} dvakrat na dan 3 tedne, pet otrok pa po načelu “po potrebi” do 1 leta.
Surrey GUI6 7SR, United Kingdom
Surrey GUI6 7SR, Velika Britanija
Potential interactions between <Invented Name> and other medicinal products have not been systematically evaluated.
Možno medsebojno delovanje med {Lastniško ime} in drugimi zdravili ni sistematično proučeno.
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of cream contains 10 mg of pimecrolimus.
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 g kreme vsebuje 10 mg pimekrolimusa.
The CHMP agreed that these skin malignancies may mimic AD and that their diagnosis can be difficult.
CHMP se je strinjal s tem, da lahko tovrstna maligna kožna obolenja posnemajo atopični dermatitis in da je njihovo diagnosticiranje težavno.
The duration of the exposure to pimecrolimus cream until the diagnosis of malignancy was also different in all cases, and it was not possible to detect any specific trend.
Tudi trajanje izpostavljenosti kremi s pimekrolimusom do postavitve diagnoze malignega obolenja je bilo od primera do primera različno, razen tega ni bilo mogoče ugotoviti nobenega specifičnega trenda.
Non-clinical pharmacology
Neklinična farmakologija
<Invented Name> cream is for external use only.
Krema <Lastniško ime> je namenjen samo za zunanjo uporabo.
If you are using <Invented Name> , do not cover the treated skin with bandages, dressings or wraps.
Če uporabljate <Lastniško ime>, ne pokrivajte kože z obvezami ali s povoji.
2Improvement=lower IGA than at baseline
2Izboljšanje=manjši IGA od izhodiščnega.
• A statement reflecting the cases of malignancies reported in the post-marketing
Navedba, ki podaja primere malignih obolenj, zabeleženih v postmarketinškem obdobju.