FrancophonIA/ELRC3.0 huggingface dataset:
English: The purpose of the third multicentre, double-blind, randomised study was the assessment of efficacy and safety of 0.03% tacrolimus ointment applied once or twice a day relative to twice daily administration of 1% hydrocortisone acetate ointment in children with moderate to severe atopic dermatitis.
Croatian: Svrha trećeg multicentričnog, dvostruko slijepog, randomiziranog ispitivanja bila je procjena djelotvornosti i sigurnosti masti sa 0,03% takrolimusa koja se nanosila jedanput ili dvaput na dan u odnosu na primjenu masti sa 1% hidrokortizon acetata dvaput na dan u djece s umjerenim do teškim atopijskim dermatitisom.
English: There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the study.
Croatian: Nije bilo klinički važnih promjena u laboratorijskim vrijednostima ili vitalnim znakovima ni u jedne skupine tijekom cijelog trajanja ispitivanja.
English: The development of any new change different from previous eczema within a treated area should be reviewed by the physician.
Croatian: Liječnik treba pregledati razvoj bilo koje nove promjene koja nastane u liječenom području, a razlikuje se od prethodnog ekcema.
English: 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.
Croatian: U bolesnika s presađenim organom, produljena sistemska izloženost jakoj imunosupresiji nakon sistemske primjene inhibitora kalcineurina povezano je s povećanim rizikom od razvoja limfoma i zloćudnih bolesti kože.
English: Protopic is available in two strengths, Protopic 0.03% and Protopic 0.1% ointment.
Croatian: Protopic je dostupan u dvije jačine, Protopic 0,03% i Protopic 0,1% mast.
English: Mechanism of action and pharmacodynamic effects The mechanism of action of tacrolimus in atopic dermatitis is not fully understood.
Croatian: Mehanizam djelovanja takrolimusa u atopijskom dermatitisu nije potpuno objašnjen.
English: • burning sensation and itching
Croatian: • osjećaj žarenja i svrbež
English: In one arm patients received Protopic 0.03% ointment (n=121) twice a day for 3 weeks and thereafter once a day until clearance.
Croatian: U jednoj se skupini bolesnicima primjenjivao Protopic 0,03% mast (n = 121) dvaput na dan tijekom 3 tjedna, a nakon toga jedanput na dan do nestanka lezija.
English: In both studies, patients with active disease entered an open-label period (OLP) during which they treated affected lesions with tacrolimus ointment twice daily until improvement had reached a predefined score (Investigator's
Croatian: U oba su ispitivanja bolesnici s aktivnom bolešću ušli u razdoblje otvorenog ispitivanja tijekom kojeg su liječili kožu zahvaćenu lezijama takrolimus mašću dvaput na dan sve dok poboljšanje nije postiglo unaprijed definirani rezultat (Opća procjena ispitivača [engl.
English: Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk.
Croatian: Podaci u ljudi pokazuju da se takrolimus nakon sistemske primjene izlučuje u majčino mlijeko.
English: 14 days
Croatian: 14 dana
English: Adverse reactions with suspected relationship to treatment are listed below by system organ class.
Croatian: Nuspojave za koje se čini da su povezane s liječenjem navedene su niže prema klasifikaciji organskih sustava.
English: Mean (SD) percentage of days of DE exacerbation treatment DE: disease exacerbation P<0.001 in favour of tacrolimus ointment 0.1% (adults) and 0.03% (children) for the primary and key secondary endpoints
Croatian: EB: egzacerbacija bolesti P < 0,001 u korist masti sa 0,1% takrolimusa (odrasli) i 0,03% takrolimusa (djeca) za primarne i ključne sekundarne ishode
English: • If you have liver failure.
Croatian: • ako imate zatajenje jetre.
English: In a photocarcinogenicity study, albino hairless mice were chronically treated with tacrolimus ointment and UV radiation.
Croatian: U ispitivanju fotokancerogenosti, albino miševi bez dlake bili su kronično izloženi takrolimus masti i
English: Usually, treatment is started with Protopic 0.1% ointment twice a day, once in the morning and once in the evening, until the eczema has cleared.
Croatian: Obično, liječenje započinje Protopic 0,1% mašću dvaput na dan, jedanput ujutro i jedanput navečer, dok ekcem ne nestane.
English: Protopic ointment contains butylhydroxytoluene (E321) as an excipient, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Croatian: Protopic mast sadrži pomoćnu tvar butilhidroksitoluen (E321), koja može uzrokovati lokalne kožne reakcije (npr. kontaktni dermatitis), ili nadražiti oči i sluznice.
English: Protopic ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Croatian: Djelotvornost i sigurnost Protopic masti u liječenju klinički inficiranog atopijskog dermatitisa nije procijenjena.
English: Erythema was a common skin irritation adverse reaction.
Croatian: Eritem je bila česta nuspojava nadraženosti kože.
English: Protopic ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression to flares.
Croatian: Protopic mast treba nanositi jedanput na dan dvaput tjedno (npr. ponedjeljkom i četvrtkom) na područja koja obično budu zahvaćena atopijskim dermatitisom kako bi se spriječilo napredovanje do rasplamsavanja bolesti.
English: Median number of DEs adjusted for time at risk (% of patients without any DE periods)
Croatian: Medijan broja EB prilagođen za rizično razdoblje (%
English: The primary endpoint was the response rate at month 3 defined as the proportion of patients with at least 60% improvement in the mEASI (modified Eczema Area and Severity Index) between baseline and month 3.
Croatian: Primarni ishod bila je stopa odgovora nakon 3 mjeseca, definirana kao udio bolesnika s najmanje 60% poboljšanja na modificiranom indeksu površine i težine ekcema (mEASI; engl.modified Eczema Area and Severity Index) do 3. mjeseca u odnosu na početno stanje.
English: Oral use of tacrolimus is also not recommended to treat these skin conditions.
Croatian: Za liječenje tih kožnih stanja ne preporučuje se ni peroralna primjena takrolimusa.
English: Adults and adolescents (16 years of age and above) Adult patients (16 years of age and above) should use Protopic 0.1% ointment.
Croatian: Odrasli i adolescenti (u dobi od 16 ili više godina) Odrasli bolesnici (u dobi od 16 ili više godina) trebaju primjenjivati Protopic 0,1% mast.
English: Tacrolimus 0.1% (N=487)
Croatian: Takrolimus 0,1% (N = 487)
English: Post-marketing cases of increased tacrolimus blood level have been reported in these conditions.
Croatian: Nakon stavljanja lijeka u promet kod tih su stanja zabilježeni slučajevi povišene razine takrolimusa u krvi.
English: In the comparator arm patients received 1% hydrocortisone acetate ointment (HA) for head and neck and 0.1% hydrocortisone butyrate ointment for trunk and limbs (n=111) twice a day for 2 weeks and subsequently HA twice a day to all affected areas.
Croatian: U usporednoj skupini bolesnicima se primjenjivala mast sa 1% hidrokortizon acetata (HA) za glavu i vrat i mast sa 0,1% hidrokortizon butirata za trup i udove (n = 111) dvaput na dan tijekom 2 tjedna te nakon toga HA
English: How to store Protopic
Croatian: Kako čuvati Protopic
English: In the second trial, children aged from 2 to 15 years with moderate to severe atopic dermatitis received twice daily treatment for three weeks of 0.03% tacrolimus ointment, 0.1% tacrolimus ointment or 1% hydrocortisone acetate ointment.
Croatian: U drugom ispitivanju, djeca od 2 do 15 godina starosti s umjerenim do teškim atopijskim dermatitisom liječena su dvaput na dan tijekom tri tjedna mašću sa 0,03% takrolimusa, mašću sa 0,1% takrolimusa ili mašću sa 1% hidrokortizon acetata.
English: In a six-month multicentre double-blind randomised trial, 0.1% tacrolimus ointment was administered twice-a-day to adults with moderate to severe atopic dermatitis and compared to a topical corticosteroid based regimen (0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck).
Croatian: U šestomjesečnom, multicentričnom, dvostruko slijepom, randomiziranom ispitivanju, mast sa 0,1% takrolimusa primjenjivana je dvaput na dan odraslima s umjerenim do teškim atopijskim dermatitisom i uspoređena s režimom na temelju topikalnih koritkosteroida (0,1% hidrokortizon butiratom za trup i ekstremitete, 1% hidrokortizon acetatom za lice i vrat).
English: Impetigo, a superficial bacterial skin infection that usually produces blisters or sores on skin, has been reported in children.
Croatian: U djece je zabilježen impetigo, površinska bakterijska kožna infekcija koja obično izaziva stvaranje mjehurića ili ranica na koži.
English: Improvement ≥ 90% in Physician's Global Evaluation
Croatian: Poboljšanje ≥ 90% prema liječničkoj ocjeni općeg stanja
English: In patients with atopic dermatitis, improvement of skin lesions during treatment with tacrolimus ointment was associated with reduced Fc receptor expression on Langerhans cells and a reduction of their hyperstimulatory activity towards T cells.
Croatian: U bolesnika s atopijskim dermatitisom poboljšanje kožnih lezija tijekom liječenja takrolimus mašću bilo je povezano sa smanjenim izražavanjem
English: Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Croatian: Odrasli i adolescenti (u dobi od 16 ili više godina) Liječenje umjerenog do teškog atopijskog dermatitisa u odraslih koji ne podnose ili nemaju prikladan odgovor na konvencionalne terapije, kao što su topikalni kortikosteroidi.
English: Paraesthesias and dysaesthesias (hyperaesthesia, burning sensation)
Croatian: Poremećaji živčanog sustava parestezije i disestezije (hiperestezija, žarenje)
English: Protopic 0.1 % ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas of your body commonly affected by atopic dermatitis.
Croatian: Protopic 0,1% mast treba primijeniti jedanput na dan dvaput tjedno (npr. ponedjeljkom i četvrtkom) na područja na tijelu koja obično budu zahvaćena atopijskim dermatitisom.
English: Protopic ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas of your body commonly affected by atopic dermatitis.
Croatian: Protopic mast treba primijeniti jedanput na dan dvaput tjedno (npr. ponedjeljkom i četvrtkom) na područja na tijelu koja obično budu zahvaćena atopijskim dermatitisom.
English: Median number of DEs requiring substantial intervention adjusted for time at risk (% of patients without DE requiring substantial intervention)
Croatian: Medijan broja EB koje su zahtijevale znatnu intervenciju prilagođeno na rizično razdoblje (%
English: The active substance of Protopic, tacrolimus monohydrate, is an immunomodulating agent.
Croatian: Djelatna tvar lijeka Protopic, takrolimus hidrat, je imunomodulirajuće sredstvo.
English: Protopic 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids.
Croatian: Protopic 0,03% mast se primjenjuje za liječenje umjerenog do teškog atopijskog dermatitisa (ekcema) u odraslih koji nemaju prikladan odgovor ili ne podnose konvencionalne terapije kao što su topikalni kortikosteroidi, i u djece (starosti 2 ili više godina) koja nisu imala prikladan odgovor na konvencionalne terapije kao što su topikalni kortikosteroidi.
English: Adults and adolescents (16 years of age and above) Adult patients should use Protopic 0.1% ointment.
Croatian: Odrasli i adolescenti (u dobi od 16 ili više godina) Odrasli bolesnici trebaju primjenjivati Protopic 0,1% mast.
English: • The active substance is tacrolimus monohydrate.
Croatian: • Djelatna tvar je takrolimus hidrat.
English: Reduced sperm function was noted in male rats at high subcutaneous doses of tacrolimus.
Croatian: Kod visokih supkutanih doza takrolimusa u mužjaka štakora bila je zabilježena smanjena funkcija spermija.
English: Butylhydroxytoluene (E321) All-rac-α-tocopherol
Croatian: (E321), sav-rac-α-tokoferol.
English: Tacrolimus 0.03% (N=189)
Croatian: Takrolimus 0,03% (N = 189)
English: defined as the proportion of patients with at least 60% improvement in the mEASI (modified Eczema Area and Severity Index) between baseline and month 3.
Croatian: 3 mjeseca definirana kao udio bolesnika s najmanje 60% poboljšanja na modificiranom indeksu površine i težine ekcema (mEASI; engl. modified Eczema Area and Severity Index) do 3. mjeseca u odnosu na početno stanje.
English: Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Croatian: Liječenje umjerenog do teškog atopijskog dermatitisa za sprječavanje rasplamsavanja i produljenja razdoblja bez rasplamsavanja u bolesnika s visokom učestalošću egzacerbacije bolesti (tj. nastaje 4 ili više puta godišnje) koji su imali početni odgovor (lezije potpuno nestale, gotovo nestale ili blago zahvaćaju kožu) na liječenje takrolimus mašću dvaput na dan u trajanju do najviše 6 tjedana.
English: Package sizes: 10 g, 30 g and 60 g. Not all pack sizes may be marketed.
Croatian: Veličine pakiranja: 10 g, 30 g i 60 g.
English: Tacrolimus 0.03% Twice daily (N=210)
Croatian: Takrolimus 0,03% dvaput na dan (N = 210)
English: Treatment of moderate to severe atopic dermatitis in children who failed to respond adequately to conventional therapies such as topical corticosteroids.
Croatian: Liječenje umjerenog do teškog atopijskog dermatitisa u djece koja nisu imala prikladan odgovor na konvencionalne terapije, kao što su topikalni kortikosteroidi.
English: In case of persistent lymphadenopathy, the aetiology of the lymphadenopathy should be investigated.
Croatian: U slučaju trajne limfadenopatije, potrebno je ispitati njezin uzrok.
English: Tacrolimus 0.03% Once daily (N=207)
Croatian: Takrolimus 0,03% jedanput na dan (N = 207)
English: Tacrolimus 0.1% Twice weekly (N=80)
Croatian: Takrolimus 0,1% Dvaput tjedno (N = 80)
English: Adults (16 years of age and older)
Croatian: Odrasli (u dobi od 16 ili više godina)
English: Children (2 years of age and above)
Croatian: Djeca (u dobi od 2 ili više godina)
English: LEO Pharma s.r.o.
Croatian: LEO Pharma S.p.A.
English: • skin tingling
Croatian: • trnci u koži • osip
English: In patients using tacrolimus ointment, cases of malignancies, including cutaneous (i.e. cutaneous T Cell lymphomas) and other types of lymphoma, and skin cancers have been reported (see section 4.8).
Croatian: U bolesnika koji primjenjuju takrolimus mast zabilježeni su slučajevi zloćudnih bolesti, uključujući kožne (npr. kožni T-stanični limfomi) i druge vrste limfoma te karcinome kože (vidjeti dio 4.8).
English: Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common.
Croatian: Nepodnošenje alkohola (naleti crvenila u licu ili nadraženost kože nakon konzumiranja alkohola) bilo je često.
English: In a subanalysis of a pooled population of patients with moderate to severe atopic dermatitis these differences remained statistically significant (Table 4).
Croatian: Ove su razlike ostale statistički značajne i u podanalizi objedinjene populacije bolesnika s umjerenim do teškim atopijskim dermatitisom (Tablica 4).
English: Median mEASI Percentage Decrease (Primary Endpoint)§ Improvement ≥ 90% in Physician's Global Evaluation § higher values = greater improvement
Croatian: Medijan mEASI stopa smanjenja (primarni ishod)§ Poboljšanje za ≥ 90% prema liječničkoj ocjeni općeg stanja
English: The response rate in the 0.1% tacrolimus group (71.6%) was significantly higher than that in the topical corticosteroid based treatment group (50.8%; p<0.001; Table 1).
Croatian: Stopa odgovora u skupini koja je primala 0,1% takrolimusa (71,6%) bila je značajno viša od onog u skupini koja je primala liječenje na temelju topikalnih kortikosteroida
English: Ointment 30 g
Croatian: Mast 30 g 60 g
English: Tacrolimus 0.1% (N=186)
Croatian: Takrolimus 0,1% (N = 186)
English: Formal topical drug interaction studies with tacrolimus ointment have not been conducted.
Croatian: Nisu provedena službena ispitivanja interakcija topikalnih lijekova i takrolimus masti.
English: Protopic 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Croatian: Protopic 0,1% mast se primjenjuje za liječenje umjerenog do teškog atopijskog dermatitisa (ekcema) u odraslih koji nemaju prikladan odgovor ili ne podnose konvencionalne terapije kao što su topikalni kortikosteroidi.
English: Package leaflet: Information for the user Protopic 0.03% ointment tacrolimus monohydrate
Croatian: Uputa o lijeku: Informacije za korisnika Protopic 0,03% mast takrolimus hidrat
English: *The adverse reaction has been reported during post-marketing experience
Croatian: *Nuspojava je bila zabilježena nakon stavljanja lijeka u promet
English: Package leaflet: Information for the user Protopic 0.1% ointment tacrolimus monohydrate
Croatian: Uputa o lijeku: Informacije za korisnika Protopic 0,1% mast takrolimus hidrat
English: However, a link to Protopic ointment treatment has not been confirmed or refuted on the available evidence so far.
Croatian: Međutim, dostupni dokazi do sada ne potvrđuju niti ne opovrgavaju njihovu povezanost s liječenjem Protopic mašću.
English: Post-marketing
Croatian: Nakon stavljanja u promet
English: The use of Protopic ointment under occlusion has not been studied in patients.
Croatian: U bolesnika nije ispitana primjena Protopic masti ispod okluzivnih povoja.
English: Rosacea (facial redness), rosacea-like dermatitis, lentigo (presence of flat brown spots on the skin), oedema at the application site and herpes eye infections have been reported during post-marketing experience.
Croatian: Rozacea (crvenilo lica), dermatitis sličan rozacei, lentigo (prisutnost ravnih smeđih pjegica na koži),
English: Tacrolimus Twice weekly (N=78)
Croatian: Takrolimus Dvaput tjedno (N = 78)
English: Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment of a flare, and if you are experiencing frequent flares (i.e. 4 or more per year), it may be possible to prevent flares coming back or prolong the time you are free from flares by using Protopic 0.1% ointment twice weekly.
Croatian: Kad se umjereni do teški atopijski dermatitis jednom potpuno povuče ili gotovo potpuno povuče nakon najviše 6 tjedana liječenja rasplamsane bolesti te ako Vam se bolest često rasplamsa (tj. 4 ili više puta godišnje), primjenom Protopic 0,1% masti dvaput tjedno može biti moguće spriječiti povratak rasplamsane bolesti ili produljiti vrijeme u kojem nemate rasplamsanu bolest.
English: Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment of a flare, and if you are experiencing frequent flares (i.e. 4 or more per year), it may be possible to prevent flares coming back or prolong the time you are free from flares by using Protopic 0.03% ointment twice weekly.
Croatian: Kad se umjereni do teški atopijski dermatitis jednom potpuno povuče ili gotovo potpuno povuče nakon najviše 6 tjedana liječenja rasplamsane bolesti te ako Vam se bolest često rasplamsa (tj. 4 ili više puta godišnje), primjenom Protopic 0,03% masti dvaput tjedno može biti moguće spriječiti povratak rasplamsane bolesti ili produljiti vrijeme u kojem nemate rasplamsanu bolest.
English: Herpes simplex, Herpes virus infection, Kaposi's varicelliform eruption*
Croatian: folikulitis, herpes simpleks, infekcija herpes virusom,
English: Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage)
Croatian: Poremećaji metabolizma i prehrane nepodnošenje alkohola (naleti crvenila u licu ili nadraženost kože nakon konzumiranja alkoholnog pića)
English: The primary endpoint was the area-under-the-curve (AUC) of the mEASI as a percentage of baseline averaged over the treatment period.
Croatian: (AUC) mEASI-a kao stopa početnih vrijednosti uprosječen za razdoblje liječenja.
English: Two strengths of Protopic (Protopic 0.03% and Protopic 0.1% ointment) are available for adult patients (16 years of age and older).
Croatian: Protopic masti (Protopic 0,03% i Protopic 0,1% mast) za odrasle bolesnike
English: An interaction study with protein-conjugated vaccine against Neisseria menigitidis serogroup C has been investigated in children aged 2-11 years.
Croatian: U djece od 2 do 11 godina starosti ispitana je interakcija s protein-konjugiranim cjepivom protiv bakterije
English: Tel:+385 1 3778 770
Croatian: Remedia d.o.o. Tel:+385 1 3778 770
English: Ointment A white to slightly yellowish ointment.
Croatian: Mast Bijela do blago žućkasta mast.
English: The efficacy and safety of tacrolimus ointment in maintenance treatment of mild to severe atopic dermatitis was assessed in 524 patients in two Phase III multicentre clinical trials of similar design,
Croatian: Djelotvornost i sigurnost takrolimus masti u terapiji održavanja kod blagog do teškog atopijskog dermatitisa bila je procijenjena u 524 bolesnika u fazi III dva multicentrična, klinička ispitivanja sličnog ustroja, jednog u odraslih bolesnika (≥ 16 godina) i jednog u pedijatrijskih bolesnika
English: Median number of DEs requiring substantial intervention adjusted for time at risk (% of patients without DE requiring substantial intervention) Median time to first DE requiring substantial intervention
Croatian: prilagođen za rizično razdoblje (% bolesnika bez ijednog razdoblja EB) Medijan vremena do prve EB
English: Skin burning, herpes simplex, alcohol intolerance (facial flushing or skin sensitivity after alcohol intake), skin tingling, hyperaesthesia, acne and fungal dermatitis occurred more often in the tacrolimus treatment group.
Croatian: Žarenje kože, herpes simpleks, nepodnošenje alkohola (naleti crvenila u licu ili osjetljivost kože nakon uzimanja alkohola),
English: Vehicle Twice weekly (N=75)
Croatian: Podloga Dvaput tjedno (N = 75)
English: 1 g ointment contains: 1.0 mg tacrolimus (as monohydrate)
Croatian: 1 g masti sadrži: 1,0 mg takrolimusa (u obliku takrolimus hidrata)
English: 1 g ointment contains: 0.3 mg tacrolimus (as monohydrate)
Croatian: 1 g masti sadrži: 0,3 mg takrolimusa (u obliku takrolimus hidrata)
English: White soft paraffin Liquid paraffin Propylene carbonate White beeswax Hard paraffin
Croatian: POPIS POMOĆNIH TVARI bijeli vazelin, tekući parafin, propilenkarbonat, bijeli pčelinji vosak, tvrdi parafin, butilhidroksitoluen
English: 1 g of Protopic 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
Croatian: 1 g Protopic 0,03% masti sadrži 0,3 mg takrolimusa u obliku takrolimus hidrata (0,03%).
English: Vehicle Twice weekly (N=73)
Croatian: Podloga Dvaput tjedno (N = 73)
English: The use of Protopic at the same time as other preparations to be used on the skin or while taking oral corticosteroids (e.g. cortisone) or medicines which affect the immune system has not been studied.
Croatian: (npr. kortizonom) ili lijekovima koji utječu na imunološki sustav nije ispitana.
English: white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321), all-rac-α-tocopherol.
Croatian: 6.1 Popis pomoćnih tvari bijeli vazelin tekući parafin propilenkarbonat bijeli pčelinji vosak tvrdi parafin butilhidroksitoluen (E321) sav-rac-α-tokoferol