natgillin/translations-raw huggingface dataset:
INFORMATION IN BRAILLE Aripiprazole Accord 15 mg 17. 
PODATKI V BRAILLOVI PISAVI Aripiprazol Accord 15 mg
Drug withdrawal syndrome neonatal (see section 4.6) 
Motnje v času nosečnosti, puerperija in perinatalnem obdobju sindrom odtegnitve zdravila pri novorojenčku (glejte poglavje 4.6)
Leukopenia Neutropenia Thrombocytopenia 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva rabdomioliza mialgija togost
Pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain. 
Roza, bikonveksne, neobložene pravokotniku podobne tablete, dolžine približno 8,1 mm in širine 4,6 mm, z vtisnjeno oznako “A10” na eni strani in brez oznake na drugi strani.
In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 56-99 years) of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease, patients treated with aripiprazole were at increased risk of death compared to placebo. 
Večja umrljivost V treh s placebom nadzorovanih preskušanjih (n = 938, povprečna starost: 82,4 leta, razpon: 56-99 let)
Blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain. 
Modre, bikonveksne, neobložene pravokotniku podobne tablete, dolžine približno 8,1 mm in širine 4,6 mm, z vtisnjeno oznako “A5” na eni strani in brez oznake na drugi strani.
The application was withdrawn after ‘day 90'. 
Vloga je bila umaknjena po „90.
This means that the CHMP had eval documentation provided by the company and formulated lists of questions. 
To pomeni, da je CHMP ocenil dokumentacijo, ki mu jo je družba predložila, in oblikoval sezname vprašanj.
a clinical trial and need more information about your treatment, contact the doctor who is 
Če ste vključeni v klinično preskušanje in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
About half of the patients took the capsule, and half were tre for 76 weeks. 
76 tednov je približno polovica bolnikov jemala kapsule, polovica pa jih je bila zdravljenih z obliži.
What was the recommendation of the CHMP at that tim 
Kakšno je bilo takrat priporočilo CHMP?
The Committee therefore considered that the pharmacokinetic data were not sufficient to draw conclusions on the effectiveness of the patch and that additional data would be required. 
Zato je menil, da farmakokinetični podatki niso bili zadostni za sklepanje o učinkovitosti obliža in da so potrebni dodatni podatki.
es this withdrawal have for patients in clinical trials? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih?
indications? 
dnevu“.
uated the er the CHMP had o the questions, there were still some unresolved issues. 
Potem ko je CHMP ocenil odgovore družbe na vprašanja, so nekatera vprašanja še vedno ostala nerešena.
The full European Public Assessment Report for Prometax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Prometax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full European Public Assessment Report for Exelon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Exelon je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
How far into the evaluation was the applicatio 
Kako daleč je bil postopek ocenjevanja vloge ob njenem umiku?
y informed the CHMP that there are no consequences for patients currently included in clinical trials with Exelon or Prometax. 
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Exelon ali Prometax.
Exelon and Prometax are medicines containing the active substance rivastigmine. 
Exelon in Prometax sta zdravili, ki vsebujeta zdravilno učinkovino rivastigmin.
The withdrawal letter can be found here. 
Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo tukaj.
The company had presented pharmacokinetic data showing that, when using the patch, rivastigmine levels in patients with Parkinson's disease were similar to the levels seen in patients with Alzheimer's, but the CHMP noted that the dementia in the two diseases was different and could respond differently to treatment. 
Družba je predložila farmakokinetične podatke, s katerimi je dokazala, da so ob uporabi obliža ravni rivastigmina pri bolnikih s Parkinsonovo boleznijo podobne ravnem, opaženim pri bolnikih z Alzheimerjevo boleznijo, vendar je CHMP opozoril, da se demenca pri teh dveh boleznih razlikuje in da se lahko bolniki različno odzivajo na zdravljenje.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Exelon/Prometax transdermal patch in the treatment of mild to moderately severe dementia associated with Parkinson's disease were uncertain and did not outweigh its risks. 
Zato je CHMP v času umika menil, da so koristi transdermalnega obliža z zdravilom Exelon/Prometax pri zdravljenju blage do zmerno hude demence, povezane s Parkinsonovo boleznijo, negotove in ne odtehtajo z njim povezanih tveganj.
The company presented the results of a study designed to assess the long-t and transdermal patch in 583 patients with mild to moderately severe dementia ass Parkinson's disease. 
Družba je predložila rezultate študije, ki je ocenjevala dolgoročne učinke kapsule in transdermalnega obliža pri 583 bolnikih z blago do zmerno hudo demenco, povezano s Parkinsonovo boleznijo.
The transdermal patches of Exelon and Prometax were also expected to be used to treat mild to moderately severe dementia associated with Parkinson's disease, which can already be treated using the capsules and oral solution. 
Transdermalni obliži z zdraviloma Exelon in Prometax naj bi se uporabljali tudi za zdravljenje blage do zmerno hude demence, povezane s Parkinsonovo boleznijo, ki jo je že mogoče zdraviti s kapsulami in peroralno raztopino.
The capsules and oral solution can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease. 
Kapsule in peroralno raztopino je mogoče uporabljati tudi za zdravljenje blage do zmerno hude demence pri bolnikih s Parkinsonovo boleznijo.
capsules, an oral solution and transdermal patches (patches tha Exelon and Prometax have been authorised in the EU since May 1998. 
Zdravili Exelon in Prometax sta v EU odobreni od meseca maja 1998.
The transdermal patches are expected to work in the same way as the capsules patients with dementia associated with Parkinson's disease, certain nerve cells die i resulting in low levels of the neurotransmitter acetylcholine (a substance that allo communicate with each other). 
Pri bolnikih z demenco, povezano s Parkinsonovo boleznijo, nekatere živčne celice v možganih odmrejo, zaradi česar se znižajo ravni živčnega prenašalca acetilholina (snovi, ki omogoča medsebojno komunikacijo med živčnimi celicami).
s of the medicine can be entia, a progressive lly affects memory, intellectual ability and behaviour. 
Vse oblike zdravila je mogoče uporabljati za zdravljenje bolnikov z blago do zmerno hudo Alzheimerjevo demenco, tj. napredujočo možgansko okvaro, ki postopoma prizadene spomin, intelektualno sposobnost in vedenje.
The active substance in Exelon and Prometax, ri blocking the enzymes that break down acetylcholine: acetylcholin By blocking these enzymes, rivastigmine allows levels of acetyl 
Zdravilna učinkovina v zdravilih Exelon in Prometax, rivastigmin, deluje tako, da zavira encime, ki razgrajujejo acetilholin: acetilholinesterazo in butirilholinesterazo.
choline to be increased in the brain, helping to reduce the symptoms of dementia in patients with Parkinson's disease. 
Rivastigmin z zaviranjem teh encimov omogoči, da se ravni acetilholina v možganih povečajo, zaradi česar se simptomi demence pri bolnikih s Parkinsonovo boleznijo ublažijo.
They are available as t deliver the medicine across the skin). 
Na voljo sta v obliki kapsul, peroralne raztopine in transdermalnih obližev (obližev, ki zdravilo dovajajo skozi kožo).
There are no consequences on the use of Exelon and Prometax in their author 
Umik nima nobenih posledic za uporabo zdravil Exelon in Prometax pri odobrenih indikacijah.
What are Exelon and Prometax? 
Kaj sta zdravili Exelon in Prometax?
What is happening with Exelon and Prometax in their authorised ised indications. 
Kakšne so posledice za zdravili Exelon in Prometax pri odobrenih indikacijah?
Based on the review of the data and the company's response to the CHMP lists time of the withdrawal, the CHMP had some concerns and was of the provisional o transdermal patch could not have been approved for the treatment of mild to 
Odbor CHMP je na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil, ob umiku izrazil določene zadržke ter je začasno menil, da transdermalnega obliža ni mogoče odobriti za zdravljenje blage do zmerno hude demence, povezane s Parkinsonovo boleznijo.
On 14 March 2012, Novartis Europ and Prometax, to add the use of the transdermal patch for the treatment of mild to dementia in patients with Parkinson's disease. 
Družba Novartis Europharm Ltd. je dne 14. marca 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za razširitev indikacij za zdravili Exelon in Prometax, s katero bi dodali uporabo transdermalnega obliža za zdravljenje simptomov blage do zmerno hude demence pri bolnikih s Parkinsonovo boleznijo.
How are Exelon and Prometax expected to work? 
Kako naj bi zdravili Exelon in Prometax delovali?
The Committee was concerned that the new study was not sufficient to conclude on of the patch in patients with dementia associated with Pa e the reasons given by the company for withdrawing the d that it decided to withdraw the application after the CHMP de on a favourable approval additional data was required, which could not be generated within the allowed timeframe. 
Družba je v uradnem dopisu navedla, da se je za umik vloge odločila, ko jo je CHMP obvestil, da za odobritev potrebuje dodatne podatke, ki jih ni bilo mogoče poslati v danem časovnem okviru.
What were Exelon and Prometax expected to be used for? 
Za kaj naj bi se zdravili Exelon in Prometax uporabljali?
The company also presented a ‘pharmacokinetic' analysis of the way rivastigmine from the patch is handled in the body th what is seen n when it was withdrawn? 
Družba je predstavila tudi „farmakokinetično“ analizo za ugotovitev, kakšni so odzivi na zdravilo rivastigmin iz obliža v telesu bolnikov z demenco, povezano s Parkinsonovo boleznijo, v primerjavi z odzivi bolnikov z Alzheimerjevo demenco.
This study was originally designed to assess the long-term safety of t transdermal patch in the treatment of dementia associated with Parkinson's dise when given to patients with dementia associated with Parkinson's disease, compared wi in patients with Alzheimer's dementia. 
Študija je bila prvotno zasnovana za ocenjevanje dolgoročne varnosti kapsul, vendar je družba kasneje razširila njen cilj, tako da je vključevala tudi oceno med koristmi in tveganji transdermalnega obliža pri zdravljenju demence, povezane s Parkinsonovo boleznijo.
of questions, at the pinion that the moderately severe dementia associated with Parkinson's disease. 
Odbor je izrazil zaskrbljenost, da nova študija ne zadošča za sklepanje o učinkovitosti obliža pri bolnikih z demenco, povezano s Parkinsonovo boleznijo.
For all epoetins 
Za vse epoetine
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 
Zdravilo se ne sme mešati z drugimi zdravili, razen s tistimi, ki so navedena v poglavju 6.6.
Adopted at the 3-6 July 2017 PRAC 
Sprejeto na seji odbora PRAC, 3.-6. julija 2017
For all epoetins - 4.4. 
Za vse epoetine - 4.4.
Hyponatraemic encephalopathy** 
Hiponatriemična encefalopatija**
<Product name> tonicity: XXX 
Toničnost zdravila <ime zdravila>: XXX
The wording below should be adapted at an individual product level and therefore, the type of variation to be submitted should be agreed with the relevant National Competent Authority (NCA) prior to the submission. 
Spodnje besedilo je treba prilagoditi na ravni posameznega zdravila, zato se je pred predložitvijo treba o vrsti spremembe, ki bo predložena, dogovoriti s pristojnim nacionalnim organom.
Blood pressure and renal function (s-creatinine) should therefore be routinely checked. 
Zato je treba redno preverjati krvni tlak in delovanje ledvic (s-kreatinin).
When renal crisis is suspected, blood pressure should be carefully controlled. 
Ob sumu na ledvično krizo je treba skrbno nadzirati krvni tlak.
Undesirable effects - subsection ‘Description of selected adverse reactions': 
Neželeni učinki - podpoglavje „Opis izbranih neželenih učinkov“:
The doctor may advise that you have your blood pressure and urine regularly checked. 
Zdravnik vam bo morda svetoval redno preverjanje krvnega tlaka in urina.
The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%) 
O najnižjem tveganju so poročali pri bolnikih z omejeno sistemsko sklerozo (2 %) in sistemsko sklerozo, ki nastopi v mladosti (1 %).
Glucose intravenous infusions are usually isotonic solutions. 
Glukozne intravenske infuzije so običajno izotonične raztopine.
Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. 
Med znaki ledvične krize povezane s sklerodermo sta povišan krvni tlak in zmanjšano izločanje urina.
Amoxicillin + clavulanic acid 
Amoksicilin + klavulanska kislina
Section Warnings and precautions - Take special care with <product name>: 
Poglavje Opozorila in previdnostni ukrepi - Pri uporabi zdravila <ime zdravila> bodite posebej previdni:
The visual signs of incompatibility are e.g. precipitation, clouding, and discoloration. 
Vidni znaki inkompatibilnosti so npr. precipitacija, skaljenost in obarvanost.
The highest risk has been reported in patients with diffuse systemic sclerosis. 
O najvišjem tveganju so poročali pri bolnikih z difuzno sistemsko sklerozo.
Side effects where the frequency is not known 
Neželeni učinki, če pogostnost ni znana
Adverse reaction (MedDRA term) 
Neželeni učinek (izraz MedDRA)
• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions 
• Alergijske (preobčutljivostne) reakcije, vključno z zatekanjem obraza, ustnic, jezika in/ali grla, ki je lahko znak anafilaktične reakcije
Undesirable effects Tabulated list of adverse reactions System Organ Class 
Neželeni učinki Preglednica z neželenimi učinki Organski sistem
Intravenous (IV) fluids containing electrolytes and/or carbohydrates - Hyponatraemia (EPITT no 18631) 
tekočine, ki vsebujejo elektrolite in/ali ogljikove hidrate - hiponatriemija (EPITT št. 18631)
Monitoring of serum sodium is particularly important for physiologically hypotonic fluids. 
Nadziranje serumskega natrija je še posebej pomembno za fiziološko hipotonične tekočine.
Scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder). 
Ledvična kriza povezana s sklerodermo pri bolnikih, ki so že oboleli za sklerodermo (avtoimunsko boleznijo).
Fulvestrant - Anaphylactic reaction (EPITT no 18832) 
Fulvestrant - anafilaktična reakcija (EPITT št. 18832)
Undesirable effects - table of ADRs - both for Chronic renal failure patients and for Cancer patients: 
Neželeni učinki - preglednica neželenih učinkov - za bolnike s kronično odpovedjo ledvic in bolnike z rakom:
You may need immediate medical treatment if you experience any of the following side effects: 
Če se pri vas pojavi kateri koli od naslednjih neželenih učinkov, boste morda potrebovali takojšnje zdravljenje:
• other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. 
• druge hude kožne reakcije lahko vključujejo spremembe barve kože, podkožne bulice, mehurje, pustule, lupljenje, rdečico, bolečino, srbenje, luščenje.
Frequency ‘unknown': Scleroderma renal crisis* *see section c) 
Neznana pogostnost: Ledvična kriza povezana s sklerodermo* *Glejte poglavje c).
If signs and symptoms suggestive of these reactions appear, <product name> should be withdrawn immediately and an alternative treatment considered. 
Če se pojavijo znaki in simptomi, ki kažejo na te reakcije, je treba zdravljenje z zdravilom <ime zdravila> takoj prekiniti in razmisliti o drugi vrsti zdravljenja.
Monitoring of serum sodium is particularly important for hypotonic fluids. 
Nadziranje serumske koncentracije natrija je še posebej pomembno za hipotonične tekočine.
Medicinal products concerned: systemic formulations of prednisolone-containing medicinal products and prednisone-containing medicinal products in doses which provide a systemic concentration equivalent to more than 15 mg prednisolone daily 
Zadevna zdravila: zdravila s prednizolonom za sistemsko uporabo in zdravila s prednizonom v odmerkih, pri katerih je sistemska koncentracija ekvivalentna več kot 15 mg prednizolona na dan.
Ciprofloxacin; meropenem - Incompatibility leading to possible precipitation when co-administered intravenously (EPITT no 18790) 
Ciprofloksacin, meropenem - nezdružljivost, ki ob sočasnem intravenskem dajanju lahko povzroča precipitacijo (EPITT št. 18790)
Immune system disorders Frequency ‘Common': Hypersensitivity reactions Frequency ‘Uncommon': Anaphylactic reactions 
Bolezni imunskega sistema Pogostnost „pogosti“: preobčutljivostne reakcije Pogostnost „občasni“: anafilaktične reakcije
If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of <product name>, treatment with <product name> must not be restarted in this patient at any time. 
Če je pri bolniku zaradi uporabe zdravila <ime zdravila> prišlo do hude kožne reakcije, kot sta SJS ali TEN, zdravljenja z zdravilom <ime zdravila> ni dovoljeno ponovno začeti.
Skin and subcutaneous tissue disorders - (frequency not known) - SJS/TEN, erythema multiforme, blistering, skin ex foliation* 
Bolezni kože in podkožja - (neznana pogostnost) - SJS/TEN, multiformni eritem, mehurji, lupljenje kože*
What you need to know before you take <product name> 
Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila> Opozorila in previdnostni ukrepi
Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solutions (e.g. penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of ciprofloxacin solutions: 3.9 - 4.5). 
Inkompatibilnost se pojavlja pri vseh raztopinah za infundiranje, ki so fizikalno ali kemično nestabilne pri pH vrednosti raztopin (npr. raztopine penicilina, heparina), še posebej v kombinaciji z raztopinami, prilagojenimi alkalnemu pH (pH raztopin ciprofloksacina: 3,9-4,5).
Summary of product characteristics (SmPC) for fluids containing glucose 
Povzetek glavnih značilnosti zdravila za tekočine, ki vsebujejo glukozo
For all epoetins except darbepoetin alfa and methoxy polyethylene glycol-epoetin beta: 4.8. 
Za vse epoetine, razen za darbepoetin alfa in metoksipolietilenglikol epoetin beta:
For topical formulations, no action is required. 
Za zdravila za topikalno uporabo ukrepanje ni potrebno.
Interaction with other medicinal products and other forms of interaction Drugs leading to an increased vasopressin effect 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
• Serious skin reactions: - a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface toxic epidermal necrolysis) - widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis) - a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis) - flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)) 
• Resne kožne reakcije: - razširjen izpuščaj z mehurčki in lupljenjem kože, še posebej okrog ust, nosu, oči in genitalij (Stevens-Johnsonov sindrom), in hujša oblika, ki povzroča obsežno lupljenje kože (več kot 30 % telesne površine toksična epidermalna nekroliza); - razširjen rdeč kožni izpuščaj z gnojnimi mehurčki (bulozni eksfoliativni dermatitis); - rdeč, luskast izpuščaj s podkožnimi bulicami in mehurji (eksantematozna pustuloza); - gripi podobni simptomi z izpuščajem, zvišano telesno temperaturo, otečenimi žlezami in nenormalni izvidi krvnih preiskav (vključno z zvišanjem belih krvnih celic (eozinofilija) in jetrnih encimov) (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)).
Hence, for other glucose containing products in this category (i.e. B05BA03 (carbohydrates) and B05BB02 (electrolytes with carbohydrates)), the SmPC adjustments may need to be adapted and merged into the actual SmPC for the particular product - such that the essence of the required adjustments are preserved. 
Zato je treba za druga zdravila v tej kategoriji, ki vsebujejo glukozo (npr. B05BA03 (ogljikovi hidrati) in B05BB02 (elektroliti z ogljikovimi hidrati)), morda prilagoditi spremembe v povzetku glavnih značilnosti zdravila in jih za določeno zdravilo združiti v aktualni povzetek glavnih značilnosti zdravila, tako da je ohranjeno bistvo zahtevanih sprememb.
Amongst the different subpopulations the occurrence of scleroderma renal crisis varies. 
Pojavnost ledvične krize povezane s sklerodermo je pri različnih skupinah različna.
Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, post-operative stress, infections, burns, and CNS diseases), patients with heart-, liver- and kidney diseases and patients exposed to vasopressin agonists (see section 4.5) are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids. 
Pri bolnikih z neosmotskim sproščanjem vazopresina (npr. pri akutni bolezni, bolečini, pooperativnem stresu, okužbah, opeklinah in boleznih osrednjega živčnega sistema), bolnikih z boleznimi srca, jeter ali ledvic ter bolnikih, izpostavljeni agonistom vazopresina (glejte poglavje 4.5) je tveganje akutne hiponatriemije pri infuziji hipotoničnih tekočin še posebej veliko.
If you develop a serious rash or another of these skin symptoms, stop taking <product name> and contact your doctor or seek medical attention immediately. 
Če se je pri vas pojavil hud izpuščaj ali eden od teh kožnih simptomov, prenehajte z jemanjem zdravila <ime zdravila> in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
Darbepoetin alfa; epoetin alfa; epoetin beta; epoetin theta; epoetin zeta; methoxy polyethylene glycol-epoetin beta - Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (EPITT no 18846) 
Darbepoetin alfa, epoetin alfa, epoetin beta, epoetin theta, epoetin zeta, metoksipolietilenglikol epoetin beta - hudi kožni neželeni učinki (SCAR), vključno s StevensJohnsonovim sindromom (SJS) in toksično epidermalno nekrolizo (TEN) (EPITT št. 18846)
Frequency ‘very rare': Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, and acute generalized exanthematous pustulosis (AGEP) (see section 4.4) and drug reaction with eosinophilia and systemic symptoms (DRESS). 
Pogostnost „zelo redka“: Kožne reakcije, kot so multiformni eritem, Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, bulozni in eksfoliativni dermatitis, inakutna generalizirana eksantemska pustuloza (AGEP) (glejte poglavje 4.4) ter reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS).