natgillin/translations-raw huggingface dataset:
Long-term effect on the local skin immune response and on the incidence of skin malignancies is unknown. < Invented Name > should not be applied to potentially malignant or pre-malignant skin lesions.
{Lastniško ime} se ne sme nanašati na potencialno maligne ali predmaligne spremembe na koži.
< Invented Name > should not be applied to areas affected by acute cutaneous viral infections (herpes simplex, chicken pox).
{Lastniško ime} ne smete nanašati na predele z akutnimi kožnimi virusnimi okužbami (herpes simpleks, norice).
< Invented Name > has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Učinkovitost in varnost {Lastniško ime} za zdravljenje klinično okuženega atopijskega dermatitisa nista ocenjeni.
Before commencing treatment with < Invented Name >, clinical infections at treatment sites should be cleared.
Pred začetkom zdravljenja z {Lastniško ime} je treba pozdraviti klinične okužbe na prizadetih predelih.
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).
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).
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.
Pri kožni okužbi s herpesom simpleksom je treba zdravljenje z {Lastniško ime} na mestu okužbe prekiniti, dokler se virusna okužba ne pozdravi.
Patients with severe atopic dermatitis may have an increased risk of skin bacterial infections (impetigo) during treatment with < Invented Name >.
Pri bolnikih s hudim atopijskim dermatitisom je lahko med zdravljenjem z {Lastniško ime} povečana nevarnost bakterijskih okužb kože (impetigo).
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.
Uporaba {Lastniško ime} lahko povzroči blage in prehodne reakcije na mestu uporabe, na primer občutek toplote in/ ali (občutek) pečenja.
13 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 off with water.
Če bolnik kremo nehote nanese na te predele, jo mora temeljito obrisati in/ ali sprati z vodo.
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”).
13 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 ”).
< Invented Name > contains cetyl alcohol and stearyl alcohol which may cause local skin reactions. < Invented Name > also contains propylene glycol, which may cause skin irritation.
{Lastniško ime} vsebuje tudi propilenglikol, ki lahko povzroča draženje kože.
< Invented Name > contains the active substance pimecrolimus, a calcineurin inhibitor.
{Lastniško ime} vsebuje zdravilno učinkovino pimekrolimus, inhibitor kalcinevrina.
In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies.
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.
Cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers have been reported in patients using pimecrolimus cream (see section 4.8).
Pri bolnikih, ki so uporabljali kremo s pimekrolimusom, so poročali o primerih maligne bolezni, vključno s kožnim in drugimi oblikami limfoma, ter kožnega raka (glejte poglavje 4. 8).
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.
< Invented Name > has not been studied in patients with Netherton’s syndrome.
Pri bolnikih z Nethertonovim sindromom {Lastniško ime} niso proučevali.
Due to the potential for increased systemic absorption of pimecrolimus, < Invented Name > is not recommended in patients with Netherton's syndrome.
Zaradi možnosti povečane sistemske absorpcije pimekrolimusa {Lastniško ime} pri bolnikih z Nethertonovim sindromom ni priporočen.
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.
The use of < Invented Name > under occlusion has not been studied in patients.
Pri bolnikih uporaba {Lastniško ime} pod okluzivnim zavojem ni bila raziskana.
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.
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.
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”).
Zaradi minimalnega obsega njegove absorpcije medsebojno delovanje med {Lastniško ime} in sistemskimi zdravili ni verjetno (glejte poglavje 5. 2 “ Farmakokinetične lastnosti ”).
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).
However, this interaction has not been studied.
Zaradi minimalnega obsega absorpcije ni verjetno, da bi prišlo do morebitnega sistemskega medsebojnega delovanja s cepljenjem, čeprav to medsebojno delovanje ni raziskano.
< Invented Name > has no photocarcinogenic potential in animals (see section 5.3. “Preclinical Safety Data”).
Pri živalih {Lastniško ime} nima fotokancerogenega delovanja (glejte poglavje 5. 3 “ Predklinični podatki o varnosti ”).
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 >.
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.
Pregnancy There are no adequate data from the use of < Invented Name > in pregnant women.
Nosečnost Ni zadostnih podatkov o uporabi {Lastniško ime} pri nosečnicah.
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.
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 ”).
However, < Invented Name > should not be used during pregnancy.
Vendar zdravila {Lastniško ime} med nosečnostjo ne smete uporabljati.
Lactation Animal studies on milk excretion after topical application were not conducted and the use of < Invented Name > in breastfeeding women has not been studied.
Dojenje Študije na živalih o izločanju v mleko po lokalni uporabi niso bile izvedene in uporabe {Lastniško ime} pri doječih materah niso preučevali.
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.
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.
Caution should be exercised when < Invented Name > is administered to breastfeeding women.
Pri zdravljenju doječih mater z {Lastniško ime} je potrebna previdnost.
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.
Doječe matere smejo uporabljati {Lastniško ime}, z izjemo na dojkah, da ne bi novorojenček nehote peroralno zaužil zdravila.
< Invented Name > has no known effect on the ability to drive and use machines.
{Lastniško ime} nima znanega vpliva na sposobnost vožnje in upravljanja s stroji.
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.
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).
- very common: application site burning.
- Zelo pogost: pečenje na mestu uporabe.
- common: application site reactions (irritation, pruritus and erythema), skin infections
- Pogosti: reakcije na mestu uporabe (draženje, srbenje in eritem), kožne okužbe (folikulitis).
- uncommon: furuncle, impetigo, herpes simplex, herpes zoster, herpes simplex dermatitis
- Občasni: furunkel, impetigo, herpes simpleks, herpes zoster, herpes simpleks dermatitis
(eczema herpeticum), molluscum contagiosum, skin papilloma, application site disorders such as rash, pain, paraesthesia, desquamation, dryness, oedema, and condition aggravated.
(eczema herpeticum), molluscum contagiosum, kožni papilom, motnje na mestu uporabe, na primer izpuščaj, bolečine, parestezije, luščenje kože, suha koža, edem in poslabšanje bolezni.
- rare: alcohol intolerance (in most cases, flushing, rash, burning, itching or swelling occurred
- Redki: alkoholna intoleranca (pri večini primerov so se rdečica, izpuščaj, pečenje, srbenje ali
shortly after the intake of alcohol), allergic skin reactions (e.g.dermatitis, urticaria).
otekanje pojavili v kratkem času po zaužitju alkohola), alergijske kožne reakcije (npr. dermatitis, urtikarija).
Post marketing:
Postmarketinške izkušnje:
Cases of malignancy, including cutaneous and other types of lymphoma, and skin cancers, have been reported in patients using pimecrolimus cream (See Section 4.4).
Pri bolnikih, ki so uporabljali kremo s pimekrolimusom, so poročali o primerih maligne bolezni, vključno s kožnim in drugimi oblikami limfoma, ter kožnega raka (glejte poglavje 4. 4).
15 4.9 Overdose
4. 9 Preveliko odmerjanje
There has been no experience of overdose with < Invented Name >.
Ni poročil o primerih prevelikega odmerjanja{ Lastniško ime}.
Other dermatologicals, ATC code:
Farmakoterapevtska skupina: druga dermatološka zdravila, Oznaka ATC:
Non-clinical pharmacology Pimecrolimus is a lipophilic anti-inflammatory ascomycin macrolactam derivative and a cell selective inhibitor of the production and release of pro-inflammatory cytokines.
Neklinična farmakologija Pimekrolimus je lipofilni protivnetni makrolaktamski derivat askomicina in celično selektiven zaviralec nastajanja in sproščanja citokinov, ki pospešujejo vnetje.
Pimecrolimus binds with high affinity to macrophilin-12 and inhibits the calcium-dependent phosphatase calcineurin.
Pimekrolimus se z veliko afiniteto veže na makrofilin- 12 in zavira od kalcija odvisno fosfatazo kalcinevrin.
Clinical data 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.
Klinični podatki 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.
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.
Children and adolescents:
Kratkotrajno (akutno) zdravljenje Otroci in mladostniki:
Two 6-week, vehicle-controlled trials were conducted including a total of 403 paediatric patients aged 2 to 17 years.
Narejeni sta bili dve šesttedenski, z vehiklom kontrolirani raziskavi, ki sta zajeli 403 pediatričnih bolnikov, starih od 2 do 17 let.
Patients were treated twice daily with < Invented Name >.
Bolniki so bili zdravljeni z {Lastniško ime} dvakrat na dan.
Infants:
Dojenčki:
A similar 6-week study was conducted in 186 patients aged 3-23 months.
Podobna šesttedenska raziskava je bila narejena na 186 bolnikih, starih 3- 23 mesecev.
Criteria
Dojenčki
d Name > (N=136) 1% (N=267)
1% Vehikel
d Name > 1% (N=123)
1%
(N=63)
Vehikel
IGA*:
(N=63)
Clear or almost clear 1 Improvement 2
Ozdravljen ozdravljen 1 Izboljšanje 2
Pruritus:
IGA *
Absent or mild Overall (mean% change)3
Ni bila izračuna - na.
56.6% 33.8% -43.6 -0.7
Ni bila izračuna - na.
< 0.001 72.4% < 0.001 -61.8
< 0, 001
Head/Neck (mean% change)3
Na splošno (povprečna - 43, 6 sprememba v%) 3
-61.1
+7, 35
* Investigators Global Assessment ° Eczema Area Severity Index (EASI): mean% change in clinical signs (erythema, infiltration, excoriation, lichenification) and body surface area involved 1: p-value based on CMH test stratified by centre 2 Improvement=lower IGA than at baseline 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:
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.
{Lastniško ime} je bil manj učinkovit kot 0, 1% betametazon- 17- valerat pri kratkotrajnem zdravljenju (3 tedne) odraslih z zmernim do hudim atopičnim dermatitisom.
Long-term treatment 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). < Invented Name > was evaluated as foundation therapy.
Dolgotrajno zdravljenje 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.
< Invented Name > was used at first signs of itching and redness to prevent progression to flares of atopic dermatitis.
{Lastniško ime} je bil uporabljen ob prvih znakih srbenja in rdečice, da bi se preprečilo napredovanje v izbruh atopijskega dermatitisa.
Only in case of a flare of severe disease not controlled by < Invented Name >, treatment with medium potency topical corticosteroids was initiated.
Zdravljenje s srednje močnimi kortikosteroidi je bilo uvedeno samo v primeru izbruha bolezni, ki ga {Lastniško ime} ni obvladal.
When corticosteroid therapy was initiated for the treatment of flares, < Invented Name > therapy was discontinued.
Kadar je bila za zdravljenje izbruhov uvedena kortikosteroidna terapija, je bilo zdravljenje z {Lastniško ime} prekinjeno.
The control group received < Invented Name > vehicle in order to maintain blinding.
Kontrolna skupina je prejemala {Lastniško ime} vehikel, da sta raziskavi ostali slepi.
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.
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)].
{Lastniško ime} 51%, kontrole 28%), dojenčki ({Lastniško ime} 57%, kontrole 28%)] brez izbruha.
< 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)].
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)].
The efficacy of < Invented Name > was maintained over time.
Učinkovitost {Lastniško ime} se je s časom ohranjala.
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.
A total of 50.0% of the patients treated
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).
17 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%.
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).
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).
Both < Invented Name > and topical corticosteroids were used without restrictions.
Polovica bolnikov v kontrolni skupini je dobivala lokalne kortikosteroide več kot 95% dni raziskave.
Half of the patients in the control group received topical corticosteroids for more than 95% of study days. < Invented Name > was less effective than 0,1% triamcinolone acetonide cream (for trunk and extremities) plus 1% hydrocortisone acetate cream (for face, neck and intertriginous areas) in the long-term treatment (52 weeks) of adults with moderate to severe atopic dermatitis.
Pri dolgotrajnem zdravljenju (52 tednov) odraslih z zmernim do težkim atopijskim dermatitisom je bil {Lastniško ime} manj učinkovit od kreme z 0, 1% triamcinolonacetonidom (za trup in ude) plus kreme z 1% hidrokortizonacetatom (za obraz, vrat in intertriginozne predele).
Frequency of application greater than twice daily has not been studied.
17 Pogostnost uporabe, večje od dvakrat na dan, ni bila proučena.
Tolerability studies demonstrated that < Invented Name > has not shown contact sensitising, phototoxic or photosensitising potential, nor did they show any cumulative irritation.
Posebne raziskave Raziskave varnosti zdravila so pokazale, da {Lastniško ime} ne povzroča kontaktne senzitizacije, fototoksičnosti, fotosenzitizacije ali iritacije zaradi kopičenja.
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.
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.
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.
Oba lokalna kortikosteroida sta povzročila značilno stanjšanje kože, merjeno z ehografijo, v primerjavi z {Lastniško ime} in vehiklom, ki nista povzročila tanjšanja kože.
Data in animals The bioavailability of pimecrolimus in mini-pigs following a single dermal dose (applied for 22h under semi-occlusion) was 0.03%.
Podatki na živalih Biološka uporabnost pimekrolimusa pri prašičkih po enem kožnem odmerku (danem za 22 ur pod semi- okluzijo) je bila 0, 03%.
Absorption in adults Systemic exposure to pimecrolimus was investigated in 12 adults with atopic dermatitis who were treated with < Invented Name > twice daily for 3 weeks.
Absorpcija pri odraslih Sistemska izpostavljenost pimekrolimusu je bila raziskana pri 12 odraslih bolnikih z atopijskim dermatitisom, zdravljenih z {Lastniško ime} dvakrat na dan 3 tedne.
The affected body surface area (BSA) ranged from 15-59%.
Telesna površina (BSA) je bila 15- 59%.
77.5% of pimecrolimus blood concentrations were below 0.5 ng/ml and 99.8% of the total samples were below 1 ng/ml.
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.
The highest pimecrolimus blood concentration was 1.4 ng/ml in one patient.
Najvišja koncentracija pimekrolimusa v krvi, izmerjena pri enem bolniku, je bila 1, 4 ng/ ml.
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.
Pri 40 odraslih bolnikih, zdravljenih z {Lastniško ime} do 1 leta, ki so imeli v izhodišču prizadetih 14 - 62% BSA, je bilo 98% koncentracij pimekrolimusa v krvi nižjih od 0, 5 ng/ ml.