natgillin/translations-raw huggingface dataset:
By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands.
Cinakalcet s povečanjem občutljivosti teh receptorjev zmanjša tvorbo paratiroidnega hormona v obščitnicah.
How has Parareg been studied?
Kako je bilo zdravilo Parareg raziskano?
What is Parareg used for?
Za kaj se zdravilo Parareg uporablja ?
What is Parareg?
Kaj je zdravilo Parareg?
The full EPAR for Parareg is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Parareg je na voljo tukaj.
How does Parareg work?
Kako zdravilo Parareg deluje?
How is Parareg used?
Kako se zdravilo Parareg uporablja?
In some cases, patients were hospitalised.
V nekaterih primerih so bili bolniki hospitalizirani.
This means that the impact of your condition on daily activities, relationships and other factors should be less than it was before.
To pomeni, da bi moral biti vpliv vašega stanja na vsakodnevne dejavnosti, odnose in druge dejavnike manjši kot prej.
*NRI: None responder imputation.
*NRI: opredeljeni kot neodzivni (None Responder Imputation).
• if you are pregnant or think you may be pregnant.
• če ste noseči ali mislite, da bi lahko bili noseči.
*At least one of these adverse reactions was reported as serious
*O vsaj enem od teh neželenih učinkov so poročali, da je bil resen.
Apremilast is not genotoxic.
Apremilast ni genotoksičen.
Do not take a dose
ne vzemite odmerka
Physical function and health-related quality of life
Telesne funkcije in z zdravjem povezana kakovost življenja
• allergic reaction
• alergična reakcija,
• feeling tired
• občutek utrujenosti,
Take the next dose at your regular time.
Naslednji odmerek vzemite ob rednem času.
Not known side effects (frequency cannot be estimated from the available data):
Neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
• rifampicin - an antibiotic used for tuberculosis
• rifampicin - antibiotik, ki se uporablja za tuberkulozo,
No re-titration is required after initial titration.
Ponovno titriranje po začetnem titriranju ni potrebno.
• The ‘treatment initiation pack' is clearly labelled to make sure you take the correct tablet at the correct time.
• ‘Pakiranje za začetek zdravljenja' je jasno označeno, da boste zagotovo vzeli pravo tableto ob pravem času.
• The ‘treatment initiation pack' will also contain enough tablets for another 8 days at the recommended dose (days 7 to 14).
• ‘Pakiranje za začetek zdravljenja' bo vsebovalo tudi dovolj tablet še za nadaljnjih 8 dni ob priporočenem odmerku (7. do 14. dan).
You will only ever need to go through this stage of gradually increasing your dose once even if you re-start treatment.
Skozi ta stadij postopnega večanja odmerka boste morali iti samo enkrat, tudi če boste ponovno začeli z zdravljenjem.
Apremilast was studied in young and elderly healthy subjects.
Apremilast so proučevali pri mladih in starejših zdravih preskušancih.
• You can take the tablets either with or without food.
• Tablete lahko jemljete s hrano ali brez nje.
• Your treatment will start at a lower dose and will gradually be increased over the first 6 days of treatment.
• Vaše zdravljenje se bo začelo z manjšim odmerkom, ki se bo prvih 6 dni zdravljenja postopoma povečeval.
• Take Otezla at about the same time each day, one tablet in the morning and one tablet in the evening.
• Zdravilo Otezla vzemite vsak dan približno ob istem času, eno tableto zjutraj in eno tableto zvečer.
Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).
Pogostnosti so opredeljene kot: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Please see additional warning in section 4.4 for patients who are underweight at beginning of treatment.
Oglejte si tudi dodatna opozorila v poglavju 4.4 za bolnike, ki imajo v začetku zdravljenja premajhno telesno maso.
Due to the study design the duration of re-treatment was variable, and ranged from 2.6 to 22.1 weeks.
Zaradi zasnove študije je bilo trajanje ponovnega zdravljenja spremenljivo in je trajalo od 2,6 do 22,1 tedna.
The mean apparent volume of distribution (Vd) is 87 L, indicative of extravascular distribution.
Povprečni navidezni volumen porazdelitve (Vd) je 87 l, kar kaže na ekstravaskularno porazdelitev.
Human plasma protein binding of apremilast is approximately 68%.
Na beljakovine humane plazme se veže približno 68 % apremilasta.
• loss of appetite
• izguba apetita,
• The active substance is apremilast.
• Učinkovina je apremilast.
Approximately one-third of patients had not received prior phototherapy, conventional systemic or biologic therapy.
Približno ena tretjina bolnikov ni prejela predhodne fototerapije, konvencionalne sistemske ali biološke terapije.
Most events occurred within the first few weeks of treatment.
Največ dogodkov se je pojavilo v prvih nekaj tednih zdravljenja.
Take the medicine pack and this leaflet with you.
Škatlo z zdravilom in to navodilo vzemite s seboj.
Concomitant treatment with biologic DMARDs, including TNF blockers, was not allowed.
Sočasno zdravljenje z biološkimi DMARDs, vključno z zaviralci TNF, ni bilo dovoljeno.
The safety and efficacy of apremilast in children aged 0 to 17 years have not been established.
Varnost in učinkovitost apremilasta pri otrocih, starih 0 do 17 let, nista bili dokazani.
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOGA II A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
In the event of overdose, symptomatic and supportive care is advised.
V primeru prevelikega odmerjanja se svetuje simptomatska in podporna oskrba.
These studies had a similar design through week 32.
Ti študiji sta bili do 32. tedna podobno oblikovani.
• if you are allergic to apremilast or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na apremilast ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
These GI adverse reactions generally occur within the first 2 weeks of treatment and usually resolve within 4 weeks.
Ti GI neželeni učinki se na splošno pojavljajo v prvih 2 tednih zdravljenja in navadno izzvenijo v 4 tednih.
Your doctor will talk to you about how to increase your dose when you first start taking Otezla.
Zdravnik se bo pogovoril z vami o tem, kako boste večali odmerek, ko boste prvič začeli jemati zdravilo Otezla.
The median duration of PsA disease was 5 years.
Mediana trajanja bolezni PsA je bila 5 let.
• severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing)
• huda alergijska reakcija (lahko vključuje otekanje obraza, ustnic, ust, jezika ali žrela, ki lahko povzroči oteženo dihanje ali požiranje).
Apremilast is associated with an increased risk of psychiatric disorders such as insomnia and depression.
Apremilast je povezan s povečanim tveganjem za psihiatrične motnje, kot sta nespečnost in depresivnost.
These improvements were maintained at week 24.
Ta izboljšanja so po 24 tednih še vedno trajala.
No fertility data is available in humans.
Pri ljudeh podatkov o plodnosti ni na voljo.
A risk to the breastfed infant cannot be excluded, therefore apremilast should not be used during breast-feeding.
Tveganja za dojenega otroka ni mogoče izključiti, zato se apremilasta med dojenjem ne sme uporabljati.
Long-term experience in open-label extension studies with apremilast was generally comparable to the 52-week studies.
Dolgoročne izkušnje v odprtih podaljšanih študijah z apremilastom so bile na splošno primerljive z 52-tedenskimi študijami.
If a patient shows no evidence of therapeutic benefit after 24 weeks, treatment should be reconsidered.
Če bolnik po 24 tednih ne kaže znakov, da mu zdravljenje koristi, je treba ponovno premisliti o zdravljenju.
A total of 18% of patients had a history of psoriatic arthritis.
Vsega skupaj je 18 % bolnikov imelo anamnezo psoriatičnega artritisa.
Placebo 30 mg twice daily APR*
placebo 30 mg dvakrat na dan APR*
What Otezla is and what it is used for
Kaj je zdravilo Otezla in za kaj ga uporabljamo
The film-coated tablets should be swallowed whole, and can be taken either with or without food.
Filmsko obložene tablete je treba pogoltniti cele, lahko se jih jemlje s hrano ali brez nje.
Genotoxicity studies
Študije genotoksičnosti
• You should continue taking Otezla until your doctor tells you to stop.
• Nadaljujte z jemanjem zdravila Otezla, dokler vam zdravnik ne naroči, da ga nehajte jemati.
The exposure in elderly subjects (65 to 85 years of age) is about 13% higher in AUC and about 6% higher in Cmax for apremilast than that in young subjects (18 to 55 years of age).
Izpostavljenost pri starejših osebah (starih 65 do 85 let) je okrog 13 % večja v AUC in okrog 6 % večja v Cmax za apremilast kot pri mladih preskušancih (starih 18 do 55 let).
An initial titration schedule is required as shown below in Table 1.
Potreben je začetni titracijski načrt, kot je prikazan v preglednici 1 v nadaljevanju.
Total Daily Dose
Celotni dnevni odmerek
The patient's response to treatment should be evaluated on a regular basis.
Bolnikov odziv na zdravljenje je treba ocenjevati v rednih presledkih.
Detailed and updated information on this medicine is available by scanning the QR code on the outer packaging with a smartphone.
Podrobne in posodobljene informacije o tem zdravilu so na voljo, če s pametnim telefonom na zunanji ovojnini skenirate kodo QR.
• suicidal ideation or behaviour
• samomorilne misli ali vedenje.
Similar response rates were observed across all weight ranges.
Podobne stopnje odzivnosti so ugotavljali v vseh podskupinah.
• When you first start taking Otezla, you will receive a ‘treatment initiation pack' which contains all the doses as listed in the table below.
• Ko boste prvič začeli jemati zdravilo Otezla, boste prejeli ‘pakiranje za začetek zdravljenja', ki vsebuje vse odmerke, navedene v preglednici v nadaljevanju.
Sun as symbol for morning dose Moon as symbol for evening dose Refer to the wallet card for daily dose
Sonce kot simbol za jutranji odmerek Mesec kot simbol za večerni odmerek Za dnevni odmerek glejte zgibanko.
Apremilast was used as a monotherapy (34.8%) or in combination with stable doses of small molecule DMARDs (65.2%).
Apremilast so uporabljali kot monoterapijo (34,8 %) ali v kombinaciji s stabilnimi odmerki nizkomolekularnih DMARDs (65,2 %).
• Do not stop taking Otezla without talking to your doctor first.
• Ne prenehajte jemati zdravila Otezla, ne da bi se prej posvetovali z zdravnikom.
• Do not use this medicine if you notice any damage or signs of tampering to the medicine packaging.
• Ne uporabljajte tega zdravila, če opazite poškodbe ali znake odpiranja ovojnine zdravila.
Pregnancy should be excluded before treatment can be initiated.
Preden se lahko uvede zdravljenje, je treba izključiti nosečnost.
QR code to be included www.otezla-eu-pil.com
Vsebuje QR kodo www.otezla-eu-pil.com
• If you miss a dose of Otezla, take it as soon as you remember.
• Če pozabite vzeti odmerek zdravila Otezla, ga vzemite, takoj ko se spomnite.
Before starting treatment with Otezla, inform your doctor if you are suffering from symptoms of worsening depression with suicidal thinking or behaviour, especially if you take any additional medicines since some of those could increase the probability of these side effects.
Pred začetkom zdravljenja z zdravilom Otezla povejte zdravniku, če imate simptome slabšajoče se depresivnosti s samomorilnimi mislimi ali vedenjem, zlasti če jemljete dodatna zdravila, saj nekatera med njimi lahko povečajo verjetnost za te neželene učinke.
This includes medicines obtained without a prescription and herbal medicines.
To vključuje zdravila brez recepta in zdravila rastlinskega izvora.
If your condition has not improved after six months of treatment, you should talk to your doctor.
Če se vaša bolezen po šestih mesecih zdravljenja ne izboljša, se posvetujte z zdravnikom.
Carcinogenicity studies in mice and rats showed no evidence of carcinogenicity related to treatment with apremilast.
Študije kancerogenosti pri miših in podganah niso pokazale znakov kancerogenosti, povezane s terapijo z apremilastom.
Day 8 - Day 14
8. dan - 14. dan
During pivotal trials the greatest improvement was observed within the first 24 weeks of treatment.
Med ključnimi preskušanji so opazili največje izboljšanje v prvih 24 tednih zdravljenja.
If patients miss a dose, the next dose should be taken as soon as possible.
Če bolnik izpusti odmerek, mora čimprej vzeti naslednji odmerek.
None of these patients had overt clinical consequences resulting from weight loss.
Nobeden od teh bolnikov ni imel očitnih kliničnih posledic, ki bi jih povzročila izguba telesne mase.
• phenytoin, phenobarbital and carbamazepine - medicines used in the treatment of seizures or epilepsy
• fenitoin, fenobarbital in karbamazepin - zdravila, ki se uporabljajo pri zdravljenju epileptičnih napadov ali epilepsije,
Psoriatic arthritis and psoriasis are usually lifelong conditions and there is currently no cure.
Psoriatični artritis in psoriaza sta običajno vseživljenjski bolezni, za kateri trenutno ni zdravila.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 15. januar 2015 Datum zadnjega podaljšanja: 23. avgust 2019
Psoriasis is an inflammatory disease of the skin, which can cause red, scaly, thick, itchy, painful patches on your skin and can also affect your scalp and nails.
Psoriaza je vnetna bolezen kože, ki lahko povzroča rdeče, luskaste, debele, srbeče, boleče krpe na koži in lahko prizadene tudi lasišče in nohte.
Fertility and early embryonic development
Plodnost in zgodnji razvoj zarodka
The median time to loss of 50% of their week 32 PASI improvement was 12.4 weeks.
Mediani čas do izgube 50 % njihovega izboljšanja PASI po 32 tednih je bil 12,4 tedna.
You may also experience sleeplessness, or depressive mood.
Pojavita se lahko tudi nespečnost ali depresivno razpoloženje.
Otezla has not been studied in children and adolescents, therefore it is not recommended for use in children and adolescents aged 17 years and under.
Pri otrocih in mladostnikih zdravila Otezla niso proučevali, zato njegova uporaba pri otrocih in mladostnikih, starih 17 let ali manj, ni priporočljiva.
Uncommon instances of suicidal thinking and behaviour (including suicide) were reported.
Poročali so o občasnih primerih samomorilnih misli in vedenja (vključno s samomorom).
Women of childbearing potential should use an effective method of contraception to prevent pregnancy during treatment.
Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijsko metodo, da preprečijo morebitno nosečnost med zdravljenjem.
• Swallow the tablets whole, preferably with water.
• Tablete pogoltnite cele, po možnosti z vodo.
• Active psoriatic arthritis - if you cannot use another type of medicine called ‘Disease-Modifying Antirheumatic Drugs' (DMARDs) or when you have tried one of these medicines and it did not work.
• aktivni psoriatični artritis - če ne morete jemati druge vrste zdravil, ki se imenujejo imunomodulirajoča protirevmatična zdravila (DMARDs), ali če ste poskusili z enim od teh zdravil, a ni delovalo;
Summary of adverse reactions in psoriatic arthritis (PsA) and/or psoriasis (PSOR)
Povzetek neželenih učinkov pri psoriatičnem artritisu (PsA) in/ali psoriazi (PSOR)
Also some other medicines can affect the way Otezla works.
Tudi nekatera druga zdravila lahko vplivajo na način delovanja zdravila Otezla.
In the event of unexplained and clinically significant weight loss, these patients should be evaluated by a medical practitioner and discontinuation of treatment should be considered.
V primeru nerazložene in klinično pomembne izgube telesne mase mora te bolnike oceniti zdravnik, v poštev pride prekinitev zdravljenja.
You may also experience sleeplessness (common), or depressive mood (common).
Pojavita se lahko tudi nespečnost (pogosto) ali depresivno razpoloženje (pogosto).
In case of an overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment is instituted.
V primeru prevelikega odmerjanja je priporočljivo, da bolnika spremljamo glede vseh znakov ali simptomov neželenih učinkov in začnemo z ustreznim simptomatskim zdravljenjem.
Apremilast did not induce mutations in an Ames assay or chromosome aberrations in cultured human peripheral blood lymphocytes in the presence or absence of metabolic activation.
Apremilast ni induciral niti mutacij v Amesovem testu niti kromosomskih aberacij v limfocitih človeške periferne krvi v kulturi v prisotnosti ali odsotnosti presnovne aktivacije.
System Organ Class Frequency
Organski sistem Pogostnost
This is because Otezla can affect the way some other medicines work.
To je potrebno, ker zdravilo Otezla lahko vpliva na način delovanja nekaterih drugih zdravil.
In particular, tell your doctor or pharmacist before taking Otezla if you are taking any of the following medicines:
Še posebej obvestite zdravnika ali farmacevta, preden začnete jemati zdravilo Otezla, če jemljete katero od naslednjih zdravil:
If you have severe kidney problems then the recommended dose of Otezla is 30 mg once a day (morning dose).
Če imate hude težave z ledvicami, je priporočeni odmerek zdravila Otezla 30 mg enkrat na dan (jutranji odmerek).
ACR responses were maintained in the long-term open label extension studies for up to 5 years.
Odzivi ACR so v dolgoročnih odprtih podaljšanih študijah trajali do 5 let.
The long-term safety of apremilast 30 mg twice daily in patients with psoriatic arthritis and psoriasis was assessed for a total duration of treatment up to 5 years.
Dolgoročno varnost apremilasta v odmerku 30 mg dvakrat na dan pri bolnikih s psoriatičnim artritisom in psoriazo so ocenili za celotno trajanje zdravljenja do 5 let.
The number of patients with arthritis mutilans and predominant spondylitis subtypes was too small to allow meaningful assessment.
Pri bolnikih z artritisom mutilansom in prevladujočimi podtipi spondilitisa je bilo število premajhno za smiselno oceno.
All developmental effects were observed during the first week of the postnatal period; no apremilast-related effects were seen during the remaining pre- and post-weaning periods, including sexual maturation, behavioural, mating, fertility and uterine parameters.
Vse učinke na razvoj so opazili v prvem tednu postnatalnega obdobja; nobenih z apremilastom povezanih učinkov niso ugotovili med preostalimi obdobji pred odstavljanjem in po odstavljanju, vključno s spolnim dozorevanjem in parametri vedenja, parjenja, plodnosti in maternice.
If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time.
Če je takrat že skoraj čas za naslednji odmerek, naj ne vzame izpuščenega odmerka in naj ob rednem času vzame naslednji odmerek.
Subjects who discontinued early prior to the time point and subjects who did not have sufficient data for a definitive determination of response status at the time point are counted as non-responders.
Preskušance, ki so predčasno prekinili sodelovanje v študiji, in preskušance, ki niso imeli dovolj podatkov za dokončno opredelitev stopnje odziva na zdravljenje v določeni časovni točki, so opredelili kot neodzivne.
The major circulating inactive metabolite is the glucuronide conjugate of O-demethylated apremilast (M12).
Poglavitni neaktivni presnovek je glukuronidni konjugat O-demetiliranega apremilasta (M12).
In clinical studies and post-marketing experience, uncommon cases of suicidal ideation and behaviour, were reported, while completed suicide was reported post-marketing.
V kliničnih študijah in pri izkušnjah v obdobju trženja so poročali o občasnih primerih samomorilnih misli in vedenja, o izvedenem samomoru pa so poročali v obdobju trženja.
Response Rate +/- SE (%)
Stopnja odzivnosti +/- SE
The clinical responses were maintained in the same parameters of peripheral activity and in the skin manifestations of psoriasis in the open-label extension studies for up to 5 years of treatment.
Klinični odzivi so trajali v istih parametrih periferne aktivnosti in v kožnih manifestacijah psoriaze v odprtih podaljšanih študijah do 5 let zdravljenja.
There are limited data about the use of apremilast in pregnant women.
Podatki o uporabi apremilasta pri nosečnicah so omejeni.
Apremilast was detected in milk of lactating mice (see section 5.3).
Apremilast so našli v mleku miši v obdobju laktacije (glejte poglavje 5.3).
Patient weight was measured routinely in clinical studies.
Telesno maso bolnikov so v kliničnih študijah merili rutinsko.
Patients 65 years of age or older may be at a higher risk of complications.
Pri bolnikih, starih 65 let in več, obstaja večje tveganje za pojav zapletov.
A total of 0.1% of patients treated with apremilast discontinued due to adverse reaction of weight decreased.
V celoti je 0,1 % bolnikov, zdravljenih z apremilastom, prekinilo zdravljenje zaradi neželenega učinka zmanjšane telesne mase.
What you need to know before you take Otezla
Kaj morate vedeti, preden boste vzeli zdravilo Otezla
Oxidative metabolism of apremilast is primarily mediated by CYP3A4, with minor contributions from CYP1A2 and CYP2A6.
Oksidativno presnovo apremilasta primarno posreduje CYP3A4, z manjšim prispevkom CYP1A2 in CYP2A6.
The recommended dose of apremilast is 30 mg taken orally twice daily, approximately 12 hours apart (morning and evening), with no food restrictions.
Priporočeni odmerek apremilasta je 30 mg peroralno dvakrat na dan, približno 12 ur narazen (zjutraj in zvečer), brez omejitev glede hrane.
There is limited pharmacokinetic data in subjects over 75 years of age in clinical trials.
V kliničnih preskušanjih je malo farmakokinetičnih podatkov za preskušance, starejše od 75 let.
Similar ACR responses were observed in patients with different PsA subtypes, including DIP.
Podobne odzive po ACR so opazili pri bolnikih z različnimi podtipi PsA, vključno z DIP.
The plasma clearance of apremilast is on average about 10 L/hr in healthy subjects, with a terminal elimination half-life of approximately 9 hours.
Povprečni plazemski očistek apremilasta je pri zdravih preskušancih okrog 10 l/h, končni razpolovni čas izločanja pa približno 9 ur.
This belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation.
Ta pripada skupini zdravil, ki se imenujejo zaviralci fosfodiesteraze 4, ki pomagajo zmanjšati vnetje.
Effects of apremilast on pregnancy included embryofoetal loss in mice and monkeys, and reduced foetal weights and delayed ossification in mice at doses higher than the currently recommended highest human dose.
Učinki apremilasta na nosečnost so vključevali izgubo zarodka in ploda pri miših in opicah in zmanjšano telesno maso ploda ter zapoznelo osifikacijo pri miših pri odmerkih, ki so bili večji od trenutno priporočenega največjega odmerka za človeka.
Responses observed in the apremilast treated group were similar in patients receiving and not receiving concomitant DMARDs, including MTX.
Odzivi, ki so jih opazili v skupini, zdravljeni z apremilastom, so bili podobni pri bolnikih, ki niso in ki so sočasno prejemali DMARDs, vključno z MTX.
There is no evidence of immunotoxic, dermal irritation, or phototoxic potential.
Ni znakov možne imunotoksičnosti, kožnega draženja ali fototoksičnosti.
For pre-clinical fertility data, see section 5.3.
Za predklinične podatke o plodnosti glejte poglavje 5.3.
People with severe kidney problems
Ljudje, ki imajo hude težave z ledvicami