natgillin/translations-raw huggingface dataset:
7 Absorption Data from healthy human subjects indicate that there is little or no systemic exposure to tacrolimus following single or repeated topical application of tacrolimus ointment.
7 Absorpcija Podatki iz raziskav zdravih preiskovancev kažejo, da je sistemska izpostavljenost takrolimusu po posamični ali ponavljajoči se lokalni uporabi mazila s takrolimusom majhna ali je sploh ni.
Most atopic dermatitis patients (adults and children) treated with single or repeated application of tacrolimus ointment (0.03 - 0.1%), and infants from age of 5 months treated with tacrolimus ointment (0.03%) had blood concentrations < 1.0 ng/ ml.
Pri večini bolnikov z atopičnim dermatitisom (odraslih in otrok), zdravljenih s posamično ali ponavljajočo se uporabo mazila s takrolimusom (0, 03 - 0, 1%), in dojenčkih starih 5 mesecev ali več zdravljenih z mazilom s takrolimusom (0, 03%), je bila koncentracija v krvi < 1, 0 ng/ ml.
When observed, blood concentrations exceeding 1.0 ng/ ml were transient.
V primerih, ko so zabeležili koncentracijo v krvi prek 1, 0 ng/ ml, je bila prehodna.
In both adults and children with an average of 50% body surface area treated, systemic exposure (i. e.
Tako pri odraslih kot pri otrocih s povprečno 50% zdravljene telesne površine je sistemska izpostavljenost (tj.
AUC) of tacrolimus from Protopic is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
AUC) takrolimusa iz Protopica približno 30- krat manjša kot po peroralnih imunosupresivnih odmerkih pri bolnikih s presajenimi ledvicami ali jetri.
Distribution As systemic exposure is low with tacrolimus ointment, the high binding of tacrolimus (> 98.8%) to plasma proteins is considered not to be clinically relevant.
Distribucija Sistemska izpostavljenost je med uporabo mazila s takrolimusom majhna, zato velika vezava takrolimusa (> 98, 8%) na beljakovine v plazmi ne velja za klinično pomembno.
Metabolism Metabolism of tacrolimus by human skin was not detectable.
Presnova V človeški koži ni bilo mogoče odkriti presnove takrolimusa.
Elimination When administered intravenously, tacrolimus has been shown to have a low clearance rate.
Eliminacija Ugotovljeno je, da je očistek intravensko uporabljenega takrolimusa majhen.
The average total body clearance is approximately 2.25 l/ h.
Povprečni celotni telesni očistek je približno 2, 25 l/ uro.
Repeated dose toxicity and local tolerance Repeated topical administration of tacrolimus ointment or the ointment vehicle to rats, rabbits and micropigs was associated with slight dermal changes such as erythema, oedema and papules.
Toksičnost ponavljajočih se odmerkov in lokalno prenašanje Večkratno lokalno aplikacijo mazila s takrolimusom ali vehikla mazila pri podganah, kuncih in mikroprašičkih so spremljale rahle dermalne spremembe, npr. eritem, edem in papule.
Carcinogenicity Systemic carcinogenicity studies in mice (18 months) and rats (24 months) revealed no carcinogenic potential of tacrolimus.
Kancerogenost Raziskave sistemske kancerogenosti pri miših (18 mesecev) in podganah (24 mesecev) niso odkrile kancerogenega potenciala takrolimusa.
In a 24-month dermal carcinogenicity study performed in mice with 0.1% ointment, no skin tumours were observed.
V 24- mesečni raziskavi dermalne kancerogenosti pri miših, opravljeni z 0, 1% mazilom, niso opazili tumorjev kože.
In a photocarcinogenicity study, albino hairless mice were chronically treated with tacrolimus ointment and UV radiation.
V raziskavi fotokancerogenosti so brezdlakave albine miši kronično zdravili z mazilom s takrolimusom in UV- obsevanjem.
Animals treated with tacrolimus ointment showed a statistically significant reduction in time to skin tumour (squamous cell carcinoma) development and an increase in the
Pri živalih, ki so jim aplicirali mazilo s takrolimusom, so ugotovili statistično značilno krajši čas do pojava kožnega tumorja (skvamozni celični karcinom) in zvečanje števila
8 number of tumours.
8 tumorjev.
Reproduction toxicity Embryo/ foetal toxicity was observed in rats and rabbits, but only at doses that caused significant toxicity in maternal animals.
Reprodukcijska toksičnost Pri podganah in kuncih so opažali toksičnost za zarodek/ plod, vendar le v odmerkih, ki so povzročili pomembne toksične učinke pri samicah- materah.
White soft paraffin Liquid paraffin Propylene carbonate White beeswax Hard paraffin
Beli vazelin Tekoči parafin Propilenkarbonat Beli vosek Trdi parafin
10 g, 30 g and 60 g.
10 g, 30 g in 60 g.
61 D-81673 München Germany
61 D- 81673 München Nemčija
EU/ 1/ 02/ 201/ 001 EU/ 1/ 02/ 201/ 002 EU/ 1/ 02/ 201/ 005
EU/ 1/ 02/ 201/ 001 EU/ 1/ 02/ 201/ 002
28/ 02/ 2002 Date of renewal:
28/ 02/ 2002 Datum podaljšanja dovoljenja za promet:
Protopic 0.1% ointment
Protopic 0, 1% mazilo
1 g of Protopic 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
1 g mazila Protopic 0, 1% vsebuje 1, 0 mg takrolimusa v obliki takrolimus monohidrata (0, 1%).
Use in elderly (65 years of age and above) Specific studies have not been conducted in elderly patients.
Uporaba pri starejših (65 let in več) Specifičnih raziskav pri starejših bolnikih ni bilo.
11 As clinical efficacy studies were performed with abrupt cessation of treatment, no information is available on whether tapering of the dosage would reduce recurrence rate.
11 V raziskavah klinične učinkovitosti so zdravljenje prekinili abruptno, zato ni podatkov, ali bi zmanjševanje odmerka zmanjšalo delež ponovitev.
In the absence of a clear aetiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Protopic should be considered.
V odsotnosti jasne etiologije za limfadenopatijo ali v navzočnosti akutne infekcijske mononukleoze je treba pretehtati opustitev Protopica.
12 Tacrolimus is extensively metabolised in the liver and although blood concentrations are low following topical therapy, the ointment should be used with caution in patients with hepatic failure (see section 5.2).
Po lokalnem zdravljenju je koncentracija v krvi sicer majhna, vednar je treba mazilo pri bolnikih z odpovedjo jeter vseeno uporabljati previdno (glejte poglavje 5. 2).
The use of Protopic ointment in patients with genetic epidermal barrier defects such as Netherton’ s syndrome is not recommended due to the potential for permanently increased systemic absorption of tacrolimus.
12 Mazila Protopic ni priporočljivo uporabljati pri bolnikih z genetskimi okvarami epidermalne pregrade, npr. pri bolnikih z Nethertonovim sindromom, ker obstaja možnost trajno zvečane sistemske absorpcije takrolimusa.
Protopic ointment should not be used during pregnancy unless clearly necessary.
Zdravila Protopic ne smete uporabljati med nosečnostjo, razen če je nujno potrebno..
Erythema was a common skin irritation adverse reaction.
Pogosto so opažali občutek toplote, bolečine, parestezije in izpuščaj na mestu uporabe.
Sensation of warmth, pain, paraesthesia and rash at the site of
Pekoč občutek na mestu uporabe,
13 application were also commonly observed.
13
Application site burning, application site pruritus Application site warmth, application site erythema, application site pain, application site irritation, application site paraesthesia, application site rash
Toplota na mestu uporabe, eritem na mestu uporabe, bolečine na mestu uporabe, draženje na mestu uporabe, parestezije na mestu uporabe, izpuščaj na mestu uporabe
14 In vitro, in Langerhans cells isolated from normal human skin, tacrolimus reduced the stimulatory activity towards T cells.
In vitro je takrolimus v Langerhansovih celicah, izoliranih iz normalne človeške kože, zmanjšal stimulacijsko delovanje na celice T.
Results from clinical studies in patients The efficacy and safety of Protopic was assessed in more than 13,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
14 Učinkovitost in varnost Protopica so ocenili pri več kot 13. 500 bolnikih, zdravljenih z mazilom s takrolimusom v kliničnih raziskavah od I. do III. faze.
15 Table 2
Tabela 2
There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the clinical trial.
Namen tretje multicentrične, dvojno slepe randomizirane raziskave je bila ocena učinkovitosti in varnosti 0, 03% mazila s takrolimusom, uporabljenega enkrat ali dvakrat na dan, v primerjavi z uporabo
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.
15 1% mazila s hidrokortizonacetatom pri otrocih z zmernim do hudim atopičnim dermatitisom.
Absorption Data from healthy human subjects indicate that there is little or no systemic exposure to tacrolimus 16 following single or repeated topical application of tacrolimus ointment.
Absorpcija Podatki iz raziskav zdravih preiskovancev kažejo, da je sistemska izpostavljenost takrolimusu po posamični ali ponavljajoči se lokalni uporabi mazila s takrolimusom majhna ali je sploh ni.
Following topical application of tacrolimus ointment, tacrolimus is selectively delivered to the skin with minimal diffusion into the systemic circulation.
16 Po lokalni uporabi mazila s takrolimusom se takrolimus selektivno sprošča v kožo in le minimalno difundira v sistemski obtok.
It is unclear whether the effect of tacrolimus is due to systemic
Ni jasno, ali je učinek takrolimusa posledica sistemske imunosupresije ali lokalnega učinka.
{DD/ MM/ YYYY}
18 {DD/ MM/ LLLL}
20 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Kerry, Ireland
Ltd., Killorglin, County Kerry, Irska
PROTOPIC 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
PROTOPIC 0, 03% MAZILO (10 g, 30 g, 60 g ŠKATLA)
Protopic 0.03% Ointment Tacrolimus monohydrate
Protopic 0, 03% mazilo Takrolimus monohidrat
1 g ointment contains:
1 g mazila vsebuje:
0.3 mg tacrolimus (as monohydrate),
0, 3 mg takrolimusa (v obliki monohidrata),
PROTOPIC 0.03% OINTMENT (10 g TUBE)
PROTOPIC 0, 03% MAZILO (10 g TUBA)
Protopic 0.03% Ointment Tacrolimus monohydrate Cutaneous use
Protopic 0, 03% mazilo Takrolimus monohidrat Za dermalno uporabo
PROTOPIC 0.03% OINTMENT (30 g, 60 g TUBE)
PROTOPIC 0, 03% MAZILO (30 g, 60 g TUBA)
Protopic 0.1% Ointment Tacrolimus monohydrate
Protopic 0, 1% mazilo Takrolimus monohidrat
1.0 mg tacrolimus (as monohydrate),
1, 0 mg takrolimusa (v obliki monohidrata),
Protopic 0.1% Ointment Tacrolimus monohydrate Cutaneous use
Protopic 0, 1% mazilo Takrolimus monohidrat Za dermalno uporabo
31 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
31 PODATKI NA PRIMARNI OVOJNINI
What Protopic is and what it is used for 2.
Kaj je zdravilo Protopic in za kaj ga uporabljamo 2.
Before you use Protopic 3.
Kaj morate vedeti, preden boste uporabili zdravilo Protopic 3.
How to use Protopic 4.
Kako uporabljati zdravilo Protopic 4.
How to store Protopic 6.
Shranjevanje zdravila Protopic 6.
WHAT PROTOPIC IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO PROTOPIC IN ZA KAJ GA UPORABLJAMO
The active substance of Protopic, tacrolimus monohydrate, is an immunomodulating agent.
Zdravilna učinkovina Protopica, takrolimus monohidrat, je imunomodulacijsko sredstvo.
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.
Protopic 0, 03% mazilo se uporablja za zdravljenje zmernega do hudega atopičnega dermatitisa (ekcema) pri odraslih, ki se na konvencionalne načine zdravljenja, kot so lokalni kortikosteroidi, ne odzovejo ustrezno ali jih ne prenašajo, in pri otrocih (starih 2 leti ali več), ki se na konvencionalne načine zdravljenja, kot so lokalni kortikosteroidi, ne odzovejo ustrezno.
In atopic dermatitis, an over-reaction of the skin’ s immune system causes skin inflammation (itchiness, redness, dryness).
Pri atopičnem dermatitisu čezmerna reakcija imunskega sistema v koži povzroči vnetje kože (srbenje, pordelost, suhost).
Protopic alters the abnormal immune response and relieves the skin inflammation and the itch.
Protopic spremeni nenormalen imunski odziv in odpravi vnetje in srbenje kože.
BEFORE YOU USE PROTOPIC
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PROTOPIC
Do not use Protopic
Ne uporabljajte zdravila Protopic
- If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Protopic or to
- Če ste alergični na (preobčutljivi za) takrolimus ali katerokoli sestavino zdravila Protopic ali na
macrolide antibiotics (e. g. azithromycin, clarithromycin, erythromycin).
makrolidne antibiotike (npr. azitromicin, klaritromicin, eritromicin).
Take special care with Protopic
Bodite posebno pozorni pri uporabi zdravila Protopic
- Protopic ointment is not approved for children younger than 2 years of age.
- Protopic ni odobren za otroke, mlajše od 2 let.
Therefore it should
Zato se ga v tej starostni skupini ne sme uporabljati.
- The effect of treatment with Protopic on the developing immune system in children, especially
- Učinek zdravljenja s Protopicom na razvijajoči se imunski sistem pri otrocih, posebno pri mlajših,
the young, has not been established.
ni ugotovljen.
- The safety of using Protopic for a long time is not known.
- Varnost dolgotrajne uporabe Protopica ni znana.
A very small number of people who
Zelo maloštevilni bolniki, ki so uporabljali
have used Protopic ointment have had malignancies (for example, skin or lymphoma).
mazilo Protopic, so imeli malignome (npr. na koži ali limfom).
However, a link to Protopic ointment treatment has not been shown.
Vendar ni dokazano, da bi bilo to povezano z zdravljenjem z mazilom Protopic.
- If you have infected lesions.
- Če so spremembe na koži okužene.
- If you have liver failure.
- Če imate odpoved jeter.
Talk to your doctor before using Protopic.
Pred uporabo Protopica se posvetujte z zdravnikom.
- Also speak to your doctor before using Protopic if you have any skin malignancies (tumours) or
- Prav tako se pred uporabo Protopica posvetujte z zdravnikom, če imate kakšen malignom (tumor)
if you have a weakened immune system (immuno-compromised) whatever the cause.
na koži ali imate zaradi kakršnegakoli razloga oslabljen imunski sistem (ste imunsko oslabeli).
- If you have an inherited skin barrier disease such as Netherton’ s syndrome or if you suffer from
Nethertonov sindrom, ali generalizirano
generalised erythroderma (inflammatory reddening and scaling of the entire skin).
eritrodermijo (vnetno pordelost in luščenje celotne kože).
- You should inform your doctor if you have swollen lymph nodes at initiation of treatment.
- Zdravniku morate povedati, če imate na začetku zdravljenja otekle bezgavke.
If
Če vam med
your lymph nodes become swollen during treatment with Protopic, consult your doctor.
zdravljenjem s Protopicom otečejo bezgavke, se posvetujte z zdravnikom.
- Before receiving a vaccination tell your doctor that you are using Protopic.
- Preden dobite kakšno cepivo, zdravniku povejte, da uporabljate Protopic.
Vaccinations should
Med zdravljenjem s
not be given during treatment and for a certain time after treatment with Protopic.
Protopicom in določen čas po zdravljenju ne smete dobiti cepiv.
For live attenuated vaccinations (e. g. measles, mumps, rubella or oral polio) the waiting time is 28 days, for inactivated vaccines (e. g. tetanus, diphtheria, pertussis or influenza) 14 days.
Z živimi atenuiranimi cepivi (npr. proti ošpicam, mumpsu, rdečkam in peroralnim proti poliu) je treba počakati 28 dni, z inaktiviranimi cepivi (npr. proti tetanusu, davici, oslovskemu kašlju ali gripi) pa 14 dni.
If
- Kože ne smete dolgo časa izpostavljati sončni svetlobi ali umetni sončni svetlobi, npr. v solarijih.
you spend time outdoors after applying Protopic, use a sunscreen and wear loose fitting clothing that protects the skin from the sun.
Če greste po uporabi Protopica na prosto, uporabite sredstvo za sončenje in oblecite ohlapna oblačila, ki kožo varujejo pred soncem.
In addition, ask your doctor for advice on other appropriate sun protection methods.
Če imate predvideno fototerapijo (zdravljenje s svetlobo), zdravniku povejte, da uporabljate Protopic.
If you are prescribed light therapy, inform your doctor that you are using Protopic as it is not recommended to use Protopic and light therapy at the same time.
Sočasna uporaba Protopica in fototerapije namreč ni priporočljiva.
- Avoid contact with the eyes or mucous membranes (inside of your nose or mouth).
- Pazite, da zdravilo ne pride v oči ali na sluznice (v nosu ali ustih).
Taking or using other medicines and cosmetics Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jemanje ali uporaba drugih zdravil in kozmetičnih sredstev Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
You may use moisturising creams and lotions during treatment with Protopic but these products should not be used within two hours of applying Protopic.
Med zdravljenjem s Protopicom lahko uporabljate vlažilne kreme in losjone, vendar teh izdelkov ne smete nanesti v razmiku manj kot dve uri od uporabe Protopica.
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.
Hkratna uporaba Protopica z drugimi pripravki, ki se uporabljajo na koži, in med jemanjem peroralnih kortikosteroidov (npr. kortizona) ali zdravil, ki vplivajo na imunski sistem, ni raziskana.
Before receiving a vaccination tell your doctor that you are using Protopic (see Section “ Take special care with Protopic”).
Preden dobite kakšno cepivo, zdravniku povejte, da uporabljate Protopic (glejte poglavje "Bodite posebno pozorni pri uporabi zdravila Protopic").
Using Protopic with food and drink While using Protopic, drinking alcohol may cause the skin or face to become flushed or red and feel hot.
Uporaba zdravila Protopic skupaj s hrano in pijačo Med uporabo Protopica lahko pitje alkohola povzroči, da koža na obrazu pordi in je vroča na otip.
Pregnancy and breast-feeding Don’ t use Protopic if you are pregnant or breast-feeding.
Nosečnost in dojenje Ne uporabljajte Protopica, če ste noseči ali če dojite.
HOW TO USE PROTOPIC
KAKO UPORABLJATI ZDRAVILO PROTOPIC
Always use Protopic exactly as your doctor has told you.
Pri uporabi zdravila Protopic natančno upoštevajte zdravnikova navodila.
Apply Protopic as a thin layer to affected areas of your skin.
Protopic na tanko namažite na prizadete predele kože.
Protopic may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees.
Protopic se lahko uporablja na večini delov telesa, tudi na obrazu, vratu in v komolčnih in kolenskih pregibih.
If the ointment gets on any of these areas, it should be thoroughly wiped off and/ or rinsed off with water.
Če pride mazilo na katerega od teh predelov, ga morate z njega temeljito obrisati in/ ali splakniti z vodo.
Wash your hands after applying Protopic unless your hands are also being treated.
Potem, ko ste nanesli Protopic, si umijte roke, razen če si zdravite tudi roke.
Before applying Protopic after a bath or shower, be sure your skin is completely dry.
Preden Protopic nanesete po kopeli ali prhanju, se prepričajte, da je koža popolnoma suha.
36 Children (2 years of age and older) Apply Protopic twice a day for up to three weeks, once in the morning and once in the evening.
36 Otroci (stari 2 leti in več) Protopic do tri tedne uporabljajte dvakrat na dan, enkrat zjutraj in enkrat zvečer.
Adults (16 years of age and older) Two strengths of Protopic (Protopic 0.03% and Protopic 0.1% ointment) are available for adult patients.
Odrasli (16 let in starejši) Za odrasle bolnike sta na voljo dve jakosti Protopica (Protopic 0, 03% in Protopic 0, 1% mazilo).
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.
Zdravljenje se ponavadi začne z mazilom Protopic 0, 1% dvakrat na dan, enkrat zjutraj in enkrat zvečer, dokler ekcem ne izgine.
If symptoms reappear, treatment with Protopic 0.1% twice a day should be restarted.
Če se simptomi znova pojavijo, je treba ponovno začeti uporabljati Protopic 0, 1% dvakrat na dan.
Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Protopic 0.03% ointment, can be used.
Glede na odziv ekcema bo zdravnik presodil, ali je mogoče pogostnost uporabe zmanjšati ali uporabiti manjšo jakost, mazilo Protopic 0, 03%.
Treatment with Protopic may be repeated if symptoms reappear.
Če se simptomi znova pojavijo, je mogoče zdravljenje s Protopicom ponoviti.
If you accidentally swallow some ointment If you accidentally swallow the ointment, consult your doctor or pharmacist as soon as possible.
Če pomotoma zaužijete nekaj mazila Če pomotoma zaužijete mazilo, se čim prej posvetujte z zdravnikom ali farmacevtom.
If you forget to use Protopic If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then continue as before.
Če ste pozabili uporabiti zdravilo Protopic Če mazilo pozabite nanesti ob predvidenem času, ga nanesite, čim se spomnite, in nato nadaljujte kot prej.
Approximately half of the patients who use Protopic have some type of skin irritation where they have applied the ointment.
Približno polovica bolnikov, ki uporabljajo Protopic, občuti neko vrsto draženja kože na mestu nanosa mazila.
These symptoms are usually mild to moderate and generally go away within one week of using Protopic.
Ti simptomi so ponavadi blagi do zmerni in praviloma minejo v enem tednu uporabe Protopica.
Other common (> 1%) side effects are redness, feeling of warmth, pain, increased skin sensitivity (especially to hot and cold), skin tingling, rash, folliculitis (inflamed or infected hair follicles) and herpes viral infections (e. g. cold sores, generalised herpes simplex infections).
Drugi pogosti (> 1%) neželeni učinki so pordelost, občutek toplote, bolečina, zvečana občutljivost kože (zlasti za vročino in mraz), mravljinčenje na koži, izpuščaj, folikulitis (vnetje ali okužbe mešičkov dlak) in herpesvirusne okužbe (npr. ocvirki, razširjene okužbe s herpes simplex).
Since commercial availability a very small number of people who have used Protopic ointment have had malignancies (for example, skin or lymphoma).
Odkar je zdravilo dostopno na trgu, so se pri zelo maloštevilnih bolnikih, ki so uporabljali mazilo Protopic, pojavili malignomi (npr. na koži ali limfom).
However, a link to Protopic ointment treatment has not been confirmed or refuted on the available evidence so far.
Vendar povezave z uporabo mazila Protopic na podlagi dosedanjih ugotovitev niso niti potrdili niti ovrgli.
HOW TO STORE PROTOPIC
SHRANJEVANJE ZDRAVILA PROTOPIC
Do not use Protopic after the expiry date which is stated on the tube and carton after EXP.
Zdravila Protopic ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na tubi in škatli poleg oznake » Uporabno do: «.
37 Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
What Protopic contains
Kaj vsebuje zdravilo Protopic
- The active substance is tacrolimus monohydrate.
- Zdravilna učinkovina je takrolimus monohidrat.
One gram of Protopic 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
En gram mazila Protopic 0, 03% vsebuje 0, 3 mg takrolimusa (v obliki takrolimus monohidrata).
beeswax and hard paraffin.
- Pomožne snovi so beli vazelin, tekoči parafin, propilenkarbonat, beli vosek in trdi parafin.
What Protopic looks like and contents of the pack Protopic is a white to slightly yellowish ointment.
Izgled zdravila Protopic in vsebina pakiranja Protopic je belo do rahlo rumenkasto mazilo.