natgillin/translations-raw huggingface dataset:
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.
The MAHs should provide to the Reference Member State (RMS), as part of the Risk Management Plan, the final copies of the educational materials for the prescribers and patients prior to distribution. 
Kot del načrta za obvladovanje tveganj morajo imetniki dovoljenja za promet z zdravilom referenčni državi članici (RMS) pred začetkom distribucije dostaviti končne izvode izobraževalnih materialov za predpisovalce zdravila in bolnike.
The present data indicate that <Invented Name> can be used simultaneously with antibiotics, antihistamines and corticosteroids (oral/nasal/inhaled). 
Trenutno dostopni podatki kažejo, da se lahko {Lastniško ime} uporablja sočasno z antibiotiki, antihistaminiki in kortikosteroidi (peroralnimi/nazalnimi/za inhalacijo).
Physicians should advise patients on appropriate sun protection measures, such as minimisation of the time in the sun, use of sunscreen product and covering the skin with appropriate clothing (see Section 4.5 “Interaction with other medicinal products and other forms of interaction”). 
Zdravniki morajo bolnikom svetovati glede ustrezne zaščite pred soncem, kot so npr. čim krajši čas sončenja, uporaba kreme za sončenje z ustreznim zaščitnim faktorjem in zaščita kože s primerno obleko (glejte poglavje 4.5 “Medsebojno delovanje z drugimi zdravili in druge oblike interakcij”).
Hypersensitivity to pimecrolimus, other macrolactams or to any of the excipients. 
Preobčutljivost za pimekrolimus, druge makrolaktame ali katerokoli pomožno snov.
DATE OF REVISION OF THE TEXT <<Date of revision>> 
DATUM ZADNJE REVIZIJE BESEDILA {Datum zadnje revizije}
The amount of active substance-related material in the skin at the application site (almost exclusively unchanged pimecrolimus) remained practically constant for 10 days. 
Količina učinkovine in sorodnih snovi, povezanih z zdravilom, v koži na mestu uporabe (praktično samo nespremenjen pimekrolimus) je v časovnem intervalu 10 dni ostala praktično konstantna.
Surrey GU16 7SR, UK 
Surrey GU16 7SR, Velika Britanija
Treatment should be intermittent, short-term and not continuous. 
Zdravljenje naj bo intermitentno, kratkotrajno in ne neprekinjeno.
The risk for humans cannot be completely ruled out as the potential for local immunosuppression with the long-term use of pimecrolimus cream is unknown. 
Tveganja za človeka ni mogogče popolnoma izključiti, ker ni znano, kakšna je možnost lokalne imunosupresije ob dolgotrajni uporabi pimekrolimusa.
Animal studies on milk excretion after topical application were not conducted and the use of <Invented Name> in breastfeeding women has not been studied. 
Študije na živalih o izločanju v mleko po lokalni uporabi niso bile izvedene in uporabe {Lastniško ime} pri doječih materah niso preučevali.
Both studies showed a significant reduction in the incidence of flares (p<0.001) in favour of <Invented Name> treatment; <Invented Name> treatment showed better efficacy in all secondary assessments (Eczema Area Severity Index, Investigators Global Assessment, subject assessment); pruritus was controlled within a week with <Invented Name>. 
Obe raziskavi sta pokazali statistično signifikantno zmanjšanje pogostnosti izbruhov (p<0,001) v korist zdravljenja z {Lastniško ime}; zdravljenje z {Lastniško ime} je pokazalo boljšo učinkovitost pri vseh sekundarnih ocenjevanjih (indeks prizadetosti ekcemskega predela, globalna ocena raziskovalcev, ocena s strani bolnika); {Lastniško ime} je obvladal pruritus znotraj enega tedna.
Based on the minimal extent of absorption, a potential systemic interaction with vaccination is unlikely to occur. 
Zaradi minimalnega obsega absorpcije ni verjetno, da bi prišlo do morebitnega sistemskega medsebojnega delovanja s cepljenjem, čeprav to medsebojno delovanje ni raziskano.
Via Umberto Boccioni, 1 21040 Origgio, Varese Italy 
Via Umberto Boccioni, 1 21040 Origgio, Varese Italija
A total of 50.0% of the patients treated with <Invented Name> did not experience any flare compared with 24.0% of the patients randomized to the control group. 
Vsega skupaj 50,0% bolnikov, zdravljenih z {Lastniško ime}, ni imelo nobenega izbruha, od bolnikov, randomiziranih v kontrolno skupino, pa ni imelo nobenega izbruha 24,0%.
Denmark requested the CHMP to give its opinion on the benefit/risk profile of pimecrolimus considering efficacy and safety concerns with regards to the potential risk of cancer. 
Danska je Odbor za zdravila za uporabo v humani medicini (CHMP) zaprosila, naj poda mnenje o razmerju med koristmi in tveganji učinkovine pimekrolimus, kar zadeva učinkovitost in varnost z ozirom na potencialno tveganje za nastanek rakavega obolenja.
Populations with potentially higher risk of systemic exposure. 
Skupine bolnikov z možnostjo večjega tveganja za sistemsko izpostavljenost
Systemic exposure to pimecrolimus was investigated in 12 adults with atopic dermatitis who were treated with <Invented Name> twice daily for 3 weeks. 
Sistemska izpostavljenost pimekrolimusu je bila raziskana pri 12 odraslih bolnikih z atopijskim dermatitisom, zdravljenih z {Lastniško ime} dvakrat na dan 3 tedne.
The MAHs should implement a comprehensive non-promotional communication plan designed to reach both prescribers and patients in order to highlight the correct use of pimecrolimus according to the approved indication; to provide guidance when to start and to stop and how to administer the cream in relation to the disease extent; and further to discourage off-label use (with regard to age groups and non-approved high risk groups). 
Imetniki dovoljenja za promet z zdravilom morajo poskrbeti za izčrpen nepromocijski načrt sporočanja, ki je zasnovan tako, da doseže tako tiste, ki zdravilo predpisujejo, kot tudi bolnike, da bi na ta način zagotovili pravilno uporabo pimekrolimusa, skladno z odobrenimi indikacijami; da bi zagotovili smernice glede tega, kdaj z uporabo kreme začeti in kdaj končati in kako jo, z ozirom na obseg obolenja, nanašati; in da bi poleg tega skušali preprečiti uporabo zdravila, ki v indikacijah ni navedena (z ozirom na starostne skupine in skupine z velikim tveganjem, pri katerih uporaba ni odobrena).
In view of the available data so far, the CHMP concluded that the long term safety of pimecrolimus needs to be further established. 
Glede na doslej razpoložljive podatke je CHMP zaključil, da je treba dolgotrajno varnost uporabe pimekrolimusa še natančneje raziskati.
<Invented Name> contains cetyl alcohol and stearyl alcohol which may cause local skin reactions. 
{Lastniško ime} vsebuje cetilalkohol in stearilalkohol, ki lahko povzročata lokalne kožne reakcije.
This may include: 
Navodilo vsebuje:
However, patients with atopic dermatitis treated with <Invented Name> have not been found to have significant systemic pimecrolimus levels. 
Vendar pa pri bolnikih z atopijskim dermatitisom, ki so se zdravili z {Lastniško ime}, niso odkrili pomembnih sistemskih koncentracij pimekrolimusa.
Storing <Invented Name> cream Further information 
Shranjevanje kreme <Lastniško ime> Dodatne informacije
After single oral administration of radiolabeled pimecrolimus in healthy subjects, unchanged pimecrolimus was the major active substance-related component in blood and there were numerous minor metabolites of moderate polarity that appeared to be products of O-demethylations and oxygenation. 
Po eni sami peroralni aplikaciji radioaktivno označenega pimekrolimusa zdravim osebam je bil nespremenjeni pimekrolimus poglavitna z učinkovino povezana sestavina v krvi, bili pa so še številni manj pomembni presnovki zmerne polarnosti, za katere se je izkazalo, da so produkti O-demetilacij in oksigenacije.
There is no clinical data beyond 1 year of treatment. 
O zdravljenju, ki bi trajalo dlje kot 1 leto, ni nobenih kliničnih podatkov.
The Committee also concluded that the product information should include warnings regarding the potential risk of malignancies and reflect the second line use. 
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.
Such reactions are generally mild/moderate, occur early in treatment and last only for a short time. 
Take reakcije so na splošno blage/zmerne, pojavijo se zgodaj v poteku zdravljenja in trajajo le kratek čas.
The systemic exposure at the LOAEL of 15mg/kg/day was 31 times the highest maximum exposure observed in a human (paediatric patient). 
Sistemska izpostavljenost koncentraciji LOAEL 15 mg/kg/dan je bila 31 krat večja od najvišje izpostavljenost pri človeku nasploh (pri pediatričnem bolniku).
- 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). 
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).
<Invented Name> should be used for as short period as possible during flares of disease. 
Trajanje uporabe {Lastniško ime} v času izbruha bolezni naj bo kar najkrajše.
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). 
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.
Laboratório Normal - Produtos Farmacêuticos, S.A Rua do Centro Empresarial, Edifício 8 
Portugalska Laboratório Normal - Produtos Farmacêuticos, S.A Rua do Centro Empresarial,
You can use <Invented Name> on all skin areas, including the head, face and neck and in the folds of the skin. 
<Lastniško ime> lahko uporabljate na vseh predelih kože, tudi na glavi, po obrazu in v kožnih pregibih.
If you accidentally swallow some <Invented Name> If you or someone else accidentally swallows <Invented Name> , tell your doctor immediately. 
Če nehote zaužijete nekaj kreme <Lastniško ime> Če vi ali kdo drug nehote zaužije <Lastniško ime>, takoj obvestite zdravnika.
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. 
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).
Therefore, in patients with extensive disease, it is recommended to administer vaccinations during treatment-free intervals. 
Zato je pri bolnikih z obsežno boleznijo priporočeno, da so cepljeni v obdobjih, ko se ne zdravijo z {Lastniško ime}.
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. 
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.
Very common side-effects, reported in more than 1 in 10 people include: A feeling of warmth and/or burning at the application site. 
Zelo pogosti neželeni učinki, o katerih poročajo pri več kot 1 od 10 ljudi, vključujejo: občutek toplote in/ali pečenja na mestu uporabe.
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. 
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.
ANNEX IV CONDITIONS OF THE MARKETING AUTHORIZATION 
DODATEK IV POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
Studies in animals after oral application have shown reproductive toxicity (see Section 5.3 “Preclinical safety data”). 
Študije na živalih po peroralnem dajanju zdravila so pokazale vpliv na razmnoževanje (glejte poglavje 5.3 “Predklinični podatki o varnosti”).
There was no increase in blood concentration over time in any patient during the 12 months of treatment. 
Pri nobenem bolniku ni koncentracija v krvi v 12 mesečnem obdobju zdravljenja sčasoma naraščala.
Your doctor may ask you to stop using <Invented Name> until the infection has been adequately controlled. 
Zdravnik vam bo morda svetoval, da prekinete z uporabo <Lastniško ime>, dokler se okužba ne pozdravi dovolj.
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 
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
<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. 
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.
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. 
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.
However, having reviewed the available data, the CHMP concluded that a potential association with the use of pimecrolimus could not be ruled out. 
Vendar pa je po pregledu razpoložljivih podatkov zaključil, da možne povezave z uporabo pimekrolimusa ni mogoče izključiti.
If you forget an application of the cream, apply it as soon as possible and then continue your normal dosing routine. 
Če ste pozabili uporabiti kremo <Lastniško ime> Če se pozabite namazati s kremo, jo nanesite čimprej in nato nadaljujte z običajnim urnikom uporabe.
Unlike corticosteroids, pimecrolimus does not cause skin atrophy in pigs and does not affect Langerhans´cells in murine skin. 
Za razliko od kortikosteroidov pimekrolimus pri prašičih ne povzroča atrofije kože in ne vpliva na Langerhansove celice v koži miši.
Stop <Invented Name> as soon as signs of eczema have disappeared. 
<Lastniško ime> prenehajte uporabljati takoj, ko znaki ekcema izginejo.
With regard to efficacy, pimecrolimus is less effective than the primary treatment for AD (topical corticosteroids). 
Kar se tiče učinkovitosti, je pimekrolimus manj učinkovit od primarnega zdravljenja atopičnega dermatitisa (z lokalno uporabljenimi kortikosteroidi).
In the 5 children treated for 1 year, blood concentrations were consistently low (maximum blood concentration was 1.94 ng/ml in 1 patient). 
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).
Cases of tumours and herpes zoster should be kept under review and regular updates should be provided in the PSURs. 
Primere tumorjev in herpesa zostra je treba preverjati, v rednih posodobljenih poročilih o varnosti pa morajo biti navedene redne posodobitve.
It works in the cells in the skin that cause the inflammation and characteristic redness and itching of eczema. 
Deluje v celicah kože, ki povzročajo vnetje in za ekcem značilno rdečino in srbenje.
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. 
Ker niso mogli ugotoviti NOAEL, niso mogli oceniti varnostne meje med ne-karcinogenimi koncentracijami pri opicah in izpostavljenostjo pri bolnikih.
WHAT <INVENTED NAME> CREAM IS AND WHAT IT IS USED FOR 
KAJ JE ZDRAVILO <LASTNIŠKO IME> KREMA IN ZA KAJ JO UPORABLJAMO
Istituto Farmaceutico S.p.A Via Umberto Boccioni, 1 21040 Origgio, Varese Italy 
Istituto Farmaceutico S.p.A Via Umberto Boccioni, 1 21040 Origgio, Varese Italija
Keep the tube tightly closed. 
Tuba naj bo ves čas dobro zaprta.
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)]. 
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.
Both <Invented Name> and topical corticosteroids were used without restrictions. 
Tako {Lastniško ime} kot kortikosteroidi so bili uporabljani brez omejitev.
Distribution, Metabolism, and Excretion 
Porazdelitev, presnova in izločanje
Apply a thin layer of <Invented Name> to the affected skin twice daily and rub in gently and completely. 
Nanesite tanko plast {Lastniško ime} na prizadeto kožo dvakrat na dan in jo nežno in popolnoma vtrite vanjo.
Topical pimecrolimus penetrates similarly into, but permeates much less through human skin than corticosteroids, indicating a very low potential of pimecrolimus for systemic absorption. 
Lokalni pimekrolimus podobno prodira v kožo kot kortikosteroidi, vendar ga mnogo manj preide skozi, kar kaže na zelo majhno verjetnost za sistemsko absorpcijo pimekrolimusa.
• A statement that pimecrolimus cream should not be used in children under 2 years. 
Opozorilo, da se pimekrolimus v kremi ne sme uporabljati pri otrocih, mlajših od dveh let.
Care should be taken to avoid contact with eyes and mucous membranes. 
Skrbno je treba paziti, da ne pride do stika zdravila z očmi in sluznicami.
If accidentally applied to these areas, the cream should be thoroughly wiped off and/or rinsed with water. 
Če kremo nehote nanesete na te predele, jo morate temeljito obrisati in/ali sprati z vodo.
Data in animals 
Podatki na živalih