FrancophonIA/ELRC3.0 huggingface dataset:
English: • Blood test result showing ‘antibodies' against your own body.
Slovenian: • rezultati krvnih preiskav, ki kažejo "protitelesa" proti lastnemu telesu
English: List of other medicines:
Slovenian: Seznam ostalih zdravil:
English: (% of patients)
Slovenian: (% bolnikov)
English: • Eye problems, including red eyes and infections
Slovenian: • težave z očmi, vključno z rdečimi očmi in okužbami
English: Radiographic changes were assessed in IMPACT 2.
Slovenian: Spremembe na rentgenskih slikah so ocenjevali v študiji IMPACT2.
English: The median duration of response was 12 weeks.
Slovenian: Mediano trajanje odziva je bilo 12 tednov.
English: Fistula Response (%) Complete fistula response (%)
Slovenian: Odziv fistule (%) Popoln odziv fistule (%)
English: No serious infusion reactions were reported.
Slovenian: Resnih infuzijskih reakcij ni bilo.
English: In addition:
Slovenian: Poleg tega še:
English: • Severe allergic reaction that may cause loss of consciousness and could be life-threatening
Slovenian: • huda alergijska reakcija, ki lahko povzroči izgubo zavesti in je lahko življenjsko nevarna
English: Pregnancy and Vaccinations
Slovenian: Nosečnost in cepljenja
English: Telephone number doctor:
Slovenian: Telefonska številka zdravnika:
English: Reduction in CDAI ≥ 25% and ≥ 70 points.
Slovenian: Zmanjšanje CDAI na ≥ 25 % oziroma ≥ 70 točk.
English: In addition, bone fracture (6.8%) was reported, however, a causal association has not been established.
Slovenian: Dodatno so poročali o zlomu kosti (6,8 %), vendar vzročna povezava ni bila dokazana.
English: For more information see section on Pregnancy and breast-feeding.
Slovenian: Za več informacij glejte poglavje o Nosečnosti in dojenju.
English: These infections are caused by specific types of fungi that can affect the lungs or other parts of your body.
Slovenian: Te okužbe povzročajo posebne vrste gliv, ki lahko prizadenejo pljuča ali druge dele telesa.
English: The median terminal half-life at these doses ranged from 8 to 9.5 days.
Slovenian: Mediani končni razpolovni čas po teh odmerkih je znašal od 8 do 9,5 dni.
English: It is important that you and your doctor record the brand name and batch number of your medicine.
Slovenian: Pomembno je, da si vi in zdravnik zabeležita ime in številko serije vašega zdravila.
English: • The table below shows how often you will usually have this medicine after your first dose.
Slovenian: • V spodnji preglednici je prikazano, kako pogosto boste običajno prejemali to zdravilo po prvem odmerku.
English: Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Slovenian: Priporočljivo je periodično pregledovanje kože, predvsem pa za tiste bolnike z dejavniki tveganja za kožnega raka.
English: • In some patients receiving Remicade, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
Slovenian: • Pri nekaterih bolnikih, ki prejemajo zdravilo Remicade, telo morda ne bo tvorilo dovolj krvnih celic, ki pomagajo v boju proti okužbam ali pri zaustavljanju krvavitve.
English: (anaphylactic shock)
Slovenian: (anafilaktični šok)
English: Furthermore, a reduction in corticosteroid use and improvements in quality of life were observed.
Slovenian: Poleg tega so opazili tudi zmanjšanje uporabe kortikosteroidov in izboljšanje kakovosti življenja.
English: • in combination with methotrexate
Slovenian: • v kombinaciji z metotreksatom
English: placebo infliximab placebo infliximab placebo infliximab placebo infliximab
Slovenian: placebo infliksimab placebo infliksimab placebo infliksimab placebo infliksimab
English: Serious infections were reported in 12% (7/60) of all treated patients.
Slovenian: O resnih okužbah so poročali pri 12 % (7/60) vseh zdravljenih bolnikov.
English: If acute infusion reactions occur, the infusion must be interrupted immediately.
Slovenian: Če se pojavi akutna z infuzijo povezana reakcija, morate infuzijo takoj prekiniti.
English: In ASPIRE, more than 90% of patients had at least two evaluable X-rays.
Slovenian: V študiji ASPIRE je imelo več kot 90 % bolnikov najmanj dve uporabni rentgenski sliki.
English: Instructions for use and handling - storage conditions
Slovenian: Navodila za uporabo in ravnanje z zdravilom - pogoji shranjevanja
English: An allergic reaction could happen within 2 hours of your injection or later.
Slovenian: Alergijska reakcija lahko nastopi v času 2 ur po injekciji pa tudi kasneje.
English: * including bovine tuberculosis (disseminated BCG infection), see section 4.4
Slovenian: * vključno z bovino tuberkulozo (razsejano okužbo BCG), glejte poglavje 4.4
English: • Medicines that affect your immune system.
Slovenian: • Zdravila, ki vplivajo na vaš imunski sistem
English: All infusion reactions were mild or moderate in intensity.
Slovenian: Vse infuzijske reakcije so bile blage ali zmerne.
English: This evaluation should include colonoscopy and biopsies per local recommendations.
Slovenian: Med te teste sodijo na primer kolonoskopija in biopsije, v skladu z lokalnimi priporočili.
English: Use of live vaccines can result in clinical infections, including disseminated infections.
Slovenian: Uporaba živih cepiv lahko povzroči klinične okužbe, vključno z razsejanimi okužbami.
English: Patients with a PGA score ≥ 3 were eligible to receive an additional infusion of the same treatment at week 26.
Slovenian: Bolniki z oceno PGA ≥ 3 so lahko prejeli dodatno infuzijo iste terapije v 26. tednu.
English: Talk to your doctor if you are on a low salt diet.
Slovenian: Posvetujte se z zdravnikom, če ste na dieti z zmanjšanim vnosom soli.
English: ACR response (% of patients)
Slovenian: Odziv ACR (% bolnikov)
English: Week 26 All randomised patients
Slovenian: 26. teden vsi randomizirani bolniki
English: Hepatitis B (HBV) reactivation
Slovenian: Reaktivacija hepatitisa B (HBV)
English: Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2 IMPACT
Slovenian: Preglednica 9 Učinki na ACR in PASI v študijah IMPACT in IMPACT 2 IMPACT
English: These medicines may cause side effects.
Slovenian: Ta zdravila lahko povzročijo neželene učinke.
English: • Lack of interest or emotion
Slovenian: • pomanjkanje interesa ali čustev
English: The patient reminder card shall contain the following key messages:
Slovenian: Opozorilna kartica za bolnika mora vsebovati naslednja pomembna sporočila:
English: A low proportion of the infusion reactions was serious allergic reactions.
Slovenian: Majhen odstotek z infuzijo povezanih reakcij so predstavljale hude alergijske reakcije.
English: Write the new expiry date on the carton including day/month/year.
Slovenian: Na škatlo napišite novi rok uporabnosti, ki vključuje dan/mesec/leto.
English: There was no difference between groups in the number of late responders thereafter.
Slovenian: Potem ni bilo več nobene razlike med skupinama glede števila bolnikov s poznim odzivom.
English: Date of latest renewal: 2 July 2009.
Slovenian: Datum prve odobritve: 13. avgust 1999 Datum zadnjega podaljšanja: 2. julij 2009
English: Janssen Biotech Inc., 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, United States of America
Slovenian: Janssen Biotech Inc. 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, Združene države Amerike
English: If you have had a break in your Remicade treatment of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
Slovenian: Če ste prekinili zdravljenje z zdravilom Remicade za več kot 16 tednov, obstaja večje tveganje za pojav alergijskih reakcij ob ponovni uvedbi zdravljenja.
English: Discuss the use of contraception during this time with your doctor.
Slovenian: Glede uporabe kontracepcije med tem časom se posvetujte z zdravnikom.
English: All patients had a history of heavy smoking.
Slovenian: Vsi bolniki so imeli v anamnezi močno kajenje.
English: Result:
Slovenian: Rezultat:
English: The available clinical experience is limited.
Slovenian: Na voljo je malo kliničnih izkušenj.
English: The interval between the last maintenance dose and the first re-induction dose ranged from 35-231 days.
Slovenian: Časovni razmik med zadnjim vzdrževalnim odmerkom zdravila in prvim odmerkom pri ponovni uporabi uvodne sheme je bil od 35 do 231 dni.
English: Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period.
Slovenian: Ker lahko izločanje infliksimaba traja do šest mesecev, morate bolnika spremljati ves ta čas.
English: It is used in adults for the following inflammatory diseases:
Slovenian: Uporablja se za zdravljenje naslednjih vnetnih bolezni pri odraslih:
English: After reconstitution and dilution:
Slovenian: Po rekonstituciji in redčenju:
English: • Cancer in children and adults
Slovenian: • rak pri otrocih in odraslih
English: The concomitant use of infliximab with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.
Slovenian: Sočasne uporabe infliksimaba s temi biološkimi zdravili ne priporočamo zaradi možnosti povečanega tveganja za okužbe in drugih možnih farmakoloških interakcij.
English: Remicade should only be used during pregnancy if your doctor feels it is necessary for you.
Slovenian: Zdravilo Remicade se lahko uporablja med nosečnostjo le, če zdravnik meni, da je to pri vas potrebno.
English: Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy.
Slovenian: Pri približno 3 % bolnikov so terapijo ustavili zaradi z infuzijo povezanih reakcij in vsi bolniki so okrevali, z ali brez medikamentozne terapije.
English: Infliximab should only be used during pregnancy if clearly needed.
Slovenian: Infliksimab se med nosečnostjo lahko uporablja le, če je nujno potrebno.
English: The new expiry date must be written on the carton.
Slovenian: Novi datum izteka roka uporabnosti je treba napisati na škatlo.
English: No further clinically relevant accumulation was observed.
Slovenian: Nadaljnjega klinično pomembnega kopičenja niso opažali.
English: • Tell your doctor if you have had treatment with Remicade in the past and are now starting Remicade treatment again.
Slovenian: • Povejte zdravniku, če ste se v preteklosti že zdravili z zdravilom Remicade in sedaj ponovno začenjate zdravljenje.
English: • Your doctor should test you for hepatitis B virus.
Slovenian: • Zdravnik vas mora testirati za virus hepatitisa B.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: 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); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: V okviru razvrstitve po organskih sistemih so neželeni učinki razvrščeni po naslednjih kategorijah pogostnosti: 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), zelo redki (< 1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: Shortened infusions at doses > 6 mg/kg have not been studied (see section 4.8).
Slovenian: Uporabe skrajšanih infuzij v odmerkih > 6 mg/kg niso proučevali (glejte poglavje 4.8).
English: Data about fistulas were derived from PCDAI scores.
Slovenian: Podatke o fistulah so pridobili iz ocen PCDAI.
English: • Reduce the signs and symptoms of your disease
Slovenian: • zmanjšanje znakov in simptomov vaše bolezni,
English: Specific studies of Remicade in elderly patients have not been conducted.
Slovenian: Specifične študije zdravila Remicade pri starejših bolnikih niso bile izvedene.
English: If you feel tired, dizzy, or unwell after having Remicade, do not drive or use any tools or machines.
Slovenian: Če se po prejemu zdravila Remicade počutite utrujeni ali se ne počutite dobro, ne smete voziti ali upravljati kakršnih koli orodij ali strojev.
English: • The doctor will decide your dose and how often you will be given Remicade.
Slovenian: • Zdravnik bo določil odmerek, ki ga boste prejemali, in kako pogosto ga boste prejemali.
English: Do not use Remicade if any of the above applies to you.
Slovenian: Ne uporabljajte zdravila Remicade, če menite, da se katero od zgoraj navedenih stanj nanaša na vas.
English: In this trial, sixty six percent of the patients (686 out of 1,040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1,040) received at least one shortened infusion of 60 minutes or less.
Slovenian: V tem preskušanju je 66 % bolnikov (686 od 1.040) prejelo najmanj eno skrajšano infuzijo v trajanju 90 minut ali manj, 44 % bolnikov (454 od 1.040) pa je prejelo najmanj eno skrajšano infuzijo v trajanju 60 minut ali manj.
English: Keep this card with you for 4 months after your dose of Remicade, or in case of pregnancy for at least 6 months after the birth of your baby.
Slovenian: To kartico nosite s seboj še 4 mesece po odmerku zdravila Remicade ali v primeru nosečnosti še vsaj 6 mesecev po rojstvu otroka.
English: • Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake "EXP".
English: Adult Crohn's disease Remicade is indicated for:
Slovenian: Crohnova bolezen pri odraslih bolnikih Remicade je indiciran za:
English: Remicade is also used in adults and children 6 years of age or older for:
Slovenian: Zdravilo Remicade se uporablja tudi za zdravljenje odraslih in otrok starih 6 let in več za:
English: Results from week 54 are shown in Table 4.
Slovenian: Rezultati za 54. teden so prikazani v Preglednici 4.
English: Prior therapy with PUVA, methotrexate, ciclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant.
Slovenian: Predhodno terapijo s PUVA, metotreksatom, ciklosporinom ali acitretinom je prejelo 71,4 % bolnikov čeprav ni nujno da so bili odporni na uvodno terapijo.
English: Post-marketing experience
Slovenian: Izkušnje iz obdobja trženja
English: What Remicade is and what it is used for
Slovenian: Kaj je zdravilo Remicade in za kaj ga uporabljamo
English: For women taking Remicade including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Slovenian: Ženskam, ki prejemajo zdravilo Remicade, vključno s starejšimi od 60 let, lahko zdravnik priporoči redne presejalne teste za raka materničnega vratu.
English: Between weeks 6 and 26, symptoms of psoriasis gradually returned with a median time to disease relapse of > 20 weeks.
Slovenian: Med 6. in 26. tednom so se simptomi psoriaze postopoma povrnili, mediana vrednost časa do ponovitve bolezni pa je bila > 20 tednov.
English: Side effects may occur a long time after your last dose.
Slovenian: Neželeni učinki se lahko pojavijo še dolgo časa po zadnjem odmerku zdravila.
English: In this situation, do not return to refrigerated storage again.
Slovenian: V tem primeru ga ne vračajte ponovno v hladilnik.
English: In P01522, improvement in signs and symptoms was also observed as early as week 2.
Slovenian: V študiji P01522 so tudi opazili izboljšanje znakov in simptomov bolezni že v 2. tednu.
English: • Changes in how your liver works, increase in liver enzymes (shown in blood tests)
Slovenian: • spremenjeno delovanje vaših jeter, povečanje vrednosti jetrnih encimov (pokaže se v izvidih krvnih preiskav)
English: Median time to loss of response through week 54
Slovenian: Mediana vrednost časa do izginotja odziva v obdobju do 54. tedna
English: • Remicade will be given to you by your doctor or nurse.
Slovenian: • Zdravilo Remicade vam bo dal zdravnik ali medicinska sestra.
English: • adult patients with active disease when the response to disease-modifying antirheumatic drugs
Slovenian: • pri odraslih bolnikih z aktivno boleznijo, kadar odziv na protirevmatična zdravila
English: The majority of the malignancies developed in the lung or head and neck.
Slovenian: Večina malignomov se je pojavila na pljučih ali na glavi in vratu.
English: After the first year of the study, 78 patients continued into an open-label extension to week 98.
Slovenian: Po prvem letu študije je 78 bolnikov nadaljevalo z odprtim podaljškom študije do 98. tedna.
English: Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Remicade can be re-administered within 16 weeks following the last infusion.
Slovenian: Ponovna uporaba zdravila pri Crohnovi bolezni in revmatoidnem artritisu Če se znaki in simptomi bolezni ponovijo, lahko zdravilo Remicade ponovno uporabite v roku 16 tednov po zadnji infuziji.
English: Failure to respond to treatment for Crohn's disease may indicate the presence of a fixed fibrotic stricture that may require surgical treatment.
Slovenian: Neodzivanje na zdravljenje pri Crohnovi bolezni lahko kaže na prisotnost stalne fibrozne strikture, zaradi katere bo morda potrebno kirurško zdravljenje.
English: All patients administered Remicade are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Slovenian: Vse bolnike, ki prejmejo zdravilo Remicade, je treba opazovati najmanj 1 do 2 uri po infuziji zaradi akutnih z infuzijo povezanih reakcij.
English: Key results are presented in Table 10.
Slovenian: Ključni izsledki so predstavljeni v Preglednici 10.
English: Remove flip-top from the vial and wipe the top with a 70% alcohol swab.
Slovenian: Odstranite ploščico na zaporki viale in njen vrh obrišite z zložencem, prepojenim s 70 % alkoholom.
English: Other paediatric indications
Slovenian: Druge pediatrične indikacije
English: It should be noted that in the majority of these reports tuberculosis was extrapulmonary, presenting as either local or disseminated disease.
Slovenian: Treba pa je poudariti, da so pri večini teh bolnikov tuberkulozo ugotovili zunaj pljuč in je šlo bodisi za lokalno ali razsejano bolezen.
English: Calculate the dose and the number of Remicade vials needed.
Slovenian: Izračunajte odmerek in število potrebnih vial zdravila Remicade.
English: Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Remicade treatment.
Slovenian: Ker pa se človeški imunoglobulini izločajo v materino mleko, matere ne smejo dojiti še najmanj 6 mesecev po zdravljenju z zdravilom Remicade.
English: • Tell your doctor if you have any heart problems, such as mild heart failure.
Slovenian: • Povejte zdravniku, če imate kakršne koli težave s srcem, kot na primer blago srčno popuščanje.
English: • Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
Slovenian: • nenormalne vrednosti beljakovine v krvi, imenovane faktor komplementa, ki je del imunskega sistema
English: Patients who have had their dose interval shortened to less than 8 weeks may be at greater risk for adverse reactions.
Slovenian: Pri bolnikih, ki so imeli razmik med odmerki skrajšan na manj kot 8 tednov, lahko obstaja večje tveganje za pojav neželenih učinkov.
English: If adequate response is achieved, patients should be continued on the selected dose or dose frequency.
Slovenian: Če dosežete zadosten odziv, naj bolnik nadaljuje z zdravljenjem z izbranim odmerkom in pogostnostjo odmerjanja.
English: • Inflammation in the eye that may cause changes in the vision, including blindness
Slovenian: • vnetje očesa, ki lahko povzroči spremembe vida, vključno s slepoto
English: The proportion of patients in clinical response at week 8 was 73.3% (44/60).
Slovenian: Delež bolnikov s kliničnim odzivom 8. teden je bil 73,3 % (44/60).
English: Cases of agranulocytosis have also been reported (see section 4.8).
Slovenian: Poročali so tudi o primerih agranulocitoze (glejte poglavje 4.8).
English: An infusion-related reaction was defined in clinical studies as any adverse event occurring during an infusion or within 1 hour after an infusion.
Slovenian: Z infuzijo povezana reakcija je bila opredeljena v kliničnih študijah kot katerikoli neželeni učinek, ki je nastopil med infuzijo ali 1 uro po infuziji.
English: • Difficult or painful breathing, chest pain
Slovenian: • težko ali boleče dihanje, bolečine v prsih
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Slovenian: Ta redka oblika limfoma celic T ima zelo agresiven potek bolezni, običajno s smrtnim izidom.
English: Concurrent use of stable doses of conventional therapies was permitted, and 83% of patients continued to receive at least one of these therapies.
Slovenian: Sočasna uporaba stalnih odmerkov konvencionalnih zdravil je bila dovoljena in 83 % bolnikov je še naprej prejemalo vsaj eno od teh terapij.
English: For storage conditions up to 25 °C before reconstitution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja do 25 °C pred rekonstitucijo zdravila glejte poglavje 6.3.
English: Overall proportions of adverse events and infusion reactions were similar between the 6 to 11 and 12 to 17 year age groups.
Slovenian: Celotni delež neželenih učinkov in infuzijskih reakcij je bil v starostni skupini od 6 do 11 let podoben kot v starostni skupini od 12 do 17 let.
English: Single doses up to 20 mg/kg have been administered without toxic effects.
Slovenian: Uporabljeni so bili enkratni odmerki infliksimaba do 20 mg/kg in ti niso povzročili toksičnih učinkov.
English: There is no evidence to suggest that infliximab worsens or causes fibrotic strictures.
Slovenian: Ni dokazov, da bi infliksimab poslabšal ali povzročil nastanek fibroznih striktur.
English: ACR 20 response* 5(10%) 34 (65%) 48 (62%) 16 (16%) 54 (54%) 53 (53%) ACR 50 response* 0(0%) 24 (46%) 35 (45%) 4 (4%) 41(41%) 33 (33%) ACR 70 response* 0(0%) 15 (29%) 27 (35%) 2 (2%) 27 (27%) 20 (20%) PASI response
Slovenian: Odziv ACR 20* 5(10 %) 34 (65 %) 48 (62 %) 16 (16 %) 54 (54 %) 53 (53 %) Odziv ACR 50* 0(0 %) 24 (46 %) 35 (45 %) 4 (4 %) 41(41 %) 33 (33 %) Odziv ACR 70* 0(0 %) 15 (29 %) 27 (35 %) 2 (2 %) 27 (27 %) 20 (20 %) Odziv PASI
English: • You are allergic to infliximab or to any of the other ingredients in Remicade (listed in section 6).
Slovenian: • če ste alergični na infliksimab ali katero koli sestavino zdravila Remicade (navedeno v poglavju 6),
English: Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino, druge glodalske beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: • It is recommended that when Remicade is prepared for infusion, it is used as soon as possible (within 3 hours).
Slovenian: • Priporočljivo je, da se pripravljeno raztopino za infuzijo zdravila Remicade uporabi čim prej (v 3 urah).
English: The efficacy of Remicade through week 54 was assessed in the ACT 1 study.
Slovenian: Učinkovitost zdravila Remicade do 54. tedna so ocenjevali v preskušanju ACT 1.
English: In vivo, infliximab rapidly forms stable complexes with human TNF, a process that parallels the loss of TNF bioactivity.
Slovenian: In vivo infliksimab hitro tvori stabilne komplekse s humanim TNF, ta proces pa poteka vzporedno z izgubo biološke aktivnosti TNF.
English: Forty six percent of patients continued on stable doses of methotrexate (≤ 25 mg/week).
Slovenian: 46 % bolnikov je zdravljenje nadaljevalo s stalnimi odmerki metotreksata (≤ 25 mg/teden).
English: • Reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery.
Slovenian: • zmanjšanje števila nenormalnih odprtin (fistul), ki tvorijo povezavo med črevesjem in kožo, in ki jih niso odpravila druga zdravila ali kirurški poseg.