natgillin/translations-raw huggingface dataset:
In the 55 weeks long term studies, the majority of these diarrhoea adverse reactions were transient, occurred early during treatment initiation and led to treatment discontinuation in 3.1% of the patients. 
Pojavili so se kmalu na začetku zdravljenja, pri 3,1 % bolnikov pa je to privedlo do prekinitve zdravljenja.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/003 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/943/003
What Velphoro contains 
Kaj vsebuje zdravilo Velphoro
No dose-dependent trends were observed in the adverse reaction profile of Velphoro. 
V profilu neželenih učinkov zdravila Velphoro ni bilo opaženih učinkov, odvisnih od odmerka.
Serum phosphorus levels must be monitored and the dose of Velphoro up or down titrated in increments of 500 mg iron (1 tablet) per day every 2 - 4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring afterwards. 
Raven fosforja v serumu je treba spremljati in vsake 2 - 4 tedne povečevati oziroma zmanjševati odmerek zdravila Velphoro v korakih po 500 mg železa (1 tableta) na dan.
Neohesperidin-dihydrochalcone Magnesium stearate 
Neohesperidin dihidrokalkon
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - BOTTLE OF 30 AND 90 CHEWABLE TABLETS 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - PLASTENKA S 30 IN 90 ŽVEČLJIVIMI TABLETAMI
Any potential bleeding from your digestive tract (stomach and gut) may be hidden by these black stools. 
Takšno črno blato lahko prikrije morebitne krvavitve v prebavnem traktu (želodcu in črevesju).
Nausea Constipation Vomiting Dyspepsia Abdominal pain Flatulence Tooth discolouration 
Navzea Zaprtje Bruhanje Dispepsija Bolečine v trebuhu Flatulenca Sprememba barve zob
- The active substance is iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches. 
- Učinkovina je železo v obliki železovega(III) oksihidroksid saharoznega kompleksa, ki je znan tudi kot mešanica polinuklearnega železovega(III) oksihidroksida, saharoze in škroba.
The active moiety of Velphoro, pn-FeOOH, is not metabolised. 
Aktivna sestavina zdravila pn­FeOOH se ne presnavlja.
Velphoro can cause discoloured (black) stool. 
Zaradi uporabe zdravila Velphoro lahko blato spremeni barvo (se obarva črno).
One phase 3 clinical study has been performed in patients with CKD on dialysis to investigate the efficacy and safety of Velphoro in this population. 
Da bi preučili učinkovitost in varnost zdravila Velphoro v tej populaciji, so pri bolnikih s KLB na dializi opravili eno klinično študijo v 3 fazah.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACK) - 90 (3 PACKS OF 30) CHEWABLE TABLETS 
ZUNANJOST ŠKATLE (VEČJE PAKIRANJE) - 90 (3 PAKIRANJA PO 30) ŽVEČLJIVIH TABLET
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON -30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE TABLETS) 
ZUNANJA ŠKATLA - 30 ŽVEČLJIVIH TABLET (5 PRETISNIH OMOTOV S PO 6 ŽVEČLJIVIMI TABLETAMI)
NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets iron as sucroferric oxyhydroxide 
Navodilo za uporabo Velphoro 500 mg žvečljive tablete železo v obliki železovega(III) oksihidroksid saharoznega kompleksa (sucroferric oxyhydroxide)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 30 AND 90 CHEWABLE TABLETS 
PODATKI NA PRIMARNI OVOJNINI NALEPKA - PLASTENKA S 30 IN 90 ŽVEČLJIVIMI TABLETAMI
There is no clinical data available with Velphoro in patients with earlier stages of renal impairment. 
Pri bolnikih z zgodnejšo fazo okvare ledvic ni na voljo kliničnih podatkov v zvezi z zdravilom Velphoro.
How to store Velphoro 
Shranjevanje zdravila Velphoro
Colloidal anhydrous silica 6.2 Incompatibilities 
Brezvodni koloidni silicijev dioksid
Diarrhoea* Faeces discoloured 
Diareja* Sprememba barve blata
Tabulated list of adverse reactions 
Povzetek neželenih učinkov v tabeli
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 6 CHEWABLE TABLETS 
PRETISNI OMOT S 6 ŽVEČLJIVIMI TABLETAMI
Information about sucrose and starches (carbohydrates) Velphoro contains sucrose. 
Zdravilo Velphoro vsebuje saharozo in škrob (ogljikovi hidrati)
Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide. 
Ena žvečljiva tableta vsebuje 500 mg železa v obliki železovega(III) oksihidroksid saharoznega kompleksa.
Velphoro contains sucrose and starches (carbohydrates) If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
Discoloured stool 
PODATKI NA ZUNANJI OVOJNINI
27 April 2010 
27. aprila 2010
The final opinion was converted into a Decision by the European Commission on 27 April 2010. 
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 27. aprila 2010.
The referral procedure started on 14 July 2009. 
Napotitveni postopek se je začel 14. julija 2009.
The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the reference Member State was Germany and the concerned Member States were Austria, Belgium, Denmark, Greece, Spain, Finland, Ireland, Italy, Luxemburg, the Netherlands, Norway, Portugal and Sweden. 
Vloga je bila predložena v skladu s členom 6 Uredbe Komisije 1084/2003/ES, pri čemer je bila referenčna država članica Nemčija, zadevne države članice pa Avstrija, Belgija, Danska, Grčija, Španija, Finska, Irska, Italija, Luksemburg, Nizozemska, Norveška, Portugalska in Švedska.
EMA/183104/2010 Veterinary Medicines 
EMA/183104/2010 Veterinarska zdravila
Article 6(12) of Regulation (EC) No 1084/2003. 
Člen 6(12) Uredbe (ES) št. 1084/2003.
International non-proprietary name (INN): ramipril 
Mednarodno nelastniško ime (INN): ramipril
The mutual recognition procedures (DE/V/0103/001/II/007, DE/V/0103/002/II/007 and DE/V/0103/004/II/007) started on 3 December 
Postopki z medsebojnim priznavanjem (DE/V/0103/001/II/007, DE/V/0103/002/II/007 in DE/V/0103/004/II/007) so se začeli 3. decembra 2008.
The rapporteur and co-rapporteur appointed were Dr. R. Breathnach and Dr. M. Holzhauser-Alberti respectively. 
Za poročevalca je bil določen dr. R. Breathnach, za soporočevalca pa dr. M. Holzhauser-Alberti.
The products are currently authorised for use in dogs for the treatment of congestive heart failure (NYHA classification grade II, III and IV) due to chronic degenerative valvular heart disease or cardiomyopathy, with or without adjunct diuretic (furosemide) or cardiac glycoside (digoxin/methyldigoxin) therapy. 
Zdravila so trenutno odobrena za uporabo pri psih za zdravljenje kongestivnega srčnega popuščanja (razreda II, III in IV po klasifikaciji NYHA) zaradi kroničnega obolenja srčnih zaklopk ali kardiomiopatije z dodatnim zdravljenjem z diuretikom (furosemidom) ali srčnim glikozidom (digoksinom/metildigoksinom) ali brez dodatnega zdravljenja.
On 2 July 2009 Belgium referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns whether the marketing authorisation should be varied by adding cats as a new target species by considering if a placebo group is deemed necessary in a clinical field trial to assess the efficacy of ramipril in cats to reduce systolic blood pressure. 
Dne 2. julija 2009 je Belgija v skladu s členom 39 Direktive 2001/82/ES, kakor je bila spremenjena s sklicevanjem na člen 6(12) Uredbe (ES) št. 1084/2003, zadevo napotila na agencijo zaradi zadržkov glede spremembe dovoljenja za promet z dodatkom mačk kot nove ciljne živalske vrste, da bi ugotovila, ali je za vrednotenje učinkovitosti ramiprila za znižanje sistoličnega krvnega tlaka pri mačkah potrebna placebo skupina v kliničnem terenskem preskušanju.
tablet for dogs 
za zdravilo Vasotop P tablete za pse
Written explanations were provided by the marketing authorisation holder on 17 August 2009. 
Imetnik dovoljenja za promet z zdravilom je pisna pojasnila predložil 17. avgusta 2009, razlage v ustni obliki pa 11. novembra 2009.
Further to rapporteurs' assessment of the currently available data, the CVMP adopted on 8 December 2009 an opinion recommending that the variation application for the veterinary medicinal products Vasotop P 0.625 mg tablet for dogs, Vasotop P 1.25 mg tablet for dogs and Vasotop P 2.5 mg tablet for dogs and associated names does not satisfy the criteria for approval in respect of efficacy. 
Na podlagi poročevalčeve ocene trenutno razpoložljivih podatkov je CVMP 8. decembra 2009 sprejel mnenje, v katerem priporoča, da vloga za spremembo zdravil za uporabo v veterinarski medicini Vasotop P 0,625 mg tablete za pse, Vasotop P 1,25 mg tablete za pse in Vasotop P 2,5 mg tablete za pse in z njim povezana imena glede učinkovitosti ne izpolnjuje meril za odobritev.
Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets are veterinary medicinal products that contain the active ingredient ramipril at concentrations of 0.625 mg, 1.25 mg and 2.5 mg respectively. 
Zdravila Vasotop P 0,625 mg, Vasotop P 1,25 mg in Vasotop P 2,5 mg tablete so zdravila za uporabo v veterinarski medicini, ki vsebujejo zdravilno učinkovino ramipril v koncentracijah 0,625 mg, 1,25 mg in 2,5 mg. Ramipril je zaviralec angiotenzinske konvertaze (ACE).
The marketing authorisation holder (Intervet International B.V.) submitted applications for a type II variation subject to mutual recognition procedures for Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets for dogs in order to include a new indication for cats as follows: For the reduction of elevated systolic blood pressure (between 160 and 230 mm Hg) and the control of associated clinical signs. 
je predložil vloge za spremembo tipa II po postopkih z medsebojnim priznavanjem za zdravila Vasotop P 0,625 mg, Vasotop P 1,25 mg in Vasotop P 2,5 mg tablete za pse, da bi vključil novo indikacijo za mačke: Za znižanje povišanega sistoličnega krvnega tlaka (med 160 in 230 mm Hg) in obvladovanje povezanih kliničnih znakov.
Opinion following an Article 6(12) referral for Vasotop P tablet for dogs EMA/183104/2010 
Mnenje v zvezi z napotitvijo v skladu s členom 6(12) za zdravilo Vasotop P tablete za pse
Including fatal outcome. 
Vključno s smrtnimi izidi.
Also tell your doctor if you are taking or have recently taken any other medicines. 
Zdravnika obvestite tudi, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
Very limited data are available. 
Na voljo je zelo malo podatkov.
In Phase 2 studies, this increase was dose-dependent. 
V študijah 2. faze je bilo to povečanje odvisno od odmerka.
Duration of follow-up ranged up to 55 months. 
Obdobje spremljanja je trajalo do 55 mesecev.
Human IgG1 crosses the placental barrier. 
Humani IgG1 prehaja preko placentarne bariere.
Table 9: Overall survival in observational studies 
Preglednica 9: Celokupno preživetje v opazovalnih študijah
Number of Patients (%) 
Število bolnikov (%)
a gp100 peptide vaccine is an experimental control. 
Peptidno cepivo gp100 je eksperimentalna kontrola.
widespread/intense pruritus regardless of etiology 
razširjeno/intenzivno srbenje ne glede na etiologijo
All patients were followed for at least 1 year. 
Vse bolnike so spremljali najmanj 1 leto.
Do not try to treat your symptoms with other medicines. 
Simptomov ne poskušajte zdraviti z drugimi zdravili.
No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years). 
O razlikah v varnosti in učinkovitosti med starostniki (≥ 65 let) in mlajšimi bolniki (< 65 let) niso poročali.
Responses are summarised in Table 11. 
Povzetek odzivov je prikazan v preglednici 11.
The primary efficacy endpoint was 1-year survival rate. 
Primarni opazovani dogodek učinkovitosti je bil delež 1-letnega preživetja.
Age ≥ 12 to 21 years 
Starost ≥12 do 21 let
In CA184178, deaths were reported at least 90 days of the last dose. 
V študiji CA184178 so o smrtnih izidih poročali najmanj 90 dni po zadnjem odmerku.
Age 12 to < 18 years 
Starost 12 do < 18 let
Children younger than 12 years of age 
Otroci, mlajši od 12 let
Tumor assessment was performed at Week 12. 
Vrednotenje tumorja je bilo izvedeno v 12. tednu.
The most common clinical presentation includes headache and fatigue. 
Najpogostejša klinična slika vključuje glavobol in utrujenost.
OTHER SPECIAL WARNING(S), IF NECESSARY For single use only. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA samo za enkratno uporabo
The median age was 57 years. 
Mediana starost je bila 57 let.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe YERVOY are provided with the following: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo YERVOY, prejeli:
Adults and adolescents 12 years of age and older 
Odrasli in mladostniki, stari 12 let in starejši
Treatment must be initiated and supervised by specialist physicians experienced in the treatment of cancer. 
Zdravljenje mora uvesti in nadzirati zdravnik specialist z izkušnjami pri zdravljenju raka.
Permanent discontinuation of treatment or withholding of doses 
Trajna ukinitev zdravljenja ali zadržanje odmerkov
Additional efficacy results are presented in Table 13. 
Dodatni rezultati učinkovitosti so prikazani v preglednici 13.
Age (2-87 years) had no clinically important effect on the CL of ipilimumab. 
Starost (2-87 let) ni imela klinično pomembnega vpliva na očistek ipilimumaba.
Data presented in those sections primarily reflect experience from a Phase 3 study, MDX010-20. 
Podatki v teh poglavjih se v glavnem nanašajo na izkušnje iz študije 3. faze, MDX010-20.
a. Summary of the safety profile 
a. Povzetek profila varnosti
The final concentration should range from 1 to 4 mg/ml. 
Končna koncentracija mora biti v razponu od 1 do 4 mg/ml.
Deaths for pediatric patients are those with on-study events within 30 days of the last dose, except for “All Deaths,” which were >30 days after the last dose. 
Smrtni izidi pri pediatričnih bolnikih so tisti dogodki med trajanjem študije, do katerih je prišlo v 30 dneh po zadnjem odmerku, razen za “Vsi smrtni izidi”, do katerih je prišlo v > 30 dneh po zadnjem odmerku.
- inflammation of the eyes. 
- vnetje oči.
Not reached (5.2, NE) 
Ni dosežena (5,2; NE)
Samsung Biologics Co. Ltd 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987 Korea 
Samsung Biologics Co. Ltd 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987 Koreja
The amount of YERVOY you will be given will be calculated based on your body weight. 
Količina zdravila YERVOY, ki jo boste prejeli, se izračuna na osnovi vaše telesne mase.
if you have recently been prescribed Zelboraf (vemurafenib, another medicine for the treatment of skin cancer). 
če so vam nedavno predpisali zdravilo Zelboraf (vemurafenib, drugo zdravilo za zdravljenje kožnega raka).
For instructions on the preparation and handling of the medicinal product before administration, see section 6.6. 
Za navodila glede priprave in ravnanja z zdravilom pred dajanjem glejte poglavje 6.6.
Disease specific precautions 
Za bolezen specifični previdnostni ukrepi
Table 3C: 
Preglednica 3C:
The study enrolled 13 patients < 12 of age and 20 patients ≥ 12 years of age. 
V študijo je bilo vključenih 13 bolnikov, starih < 12 let, in 20 bolnikov, starih ≥ 12 let.
If there are signs of adrenal insufficiency but the patient is not in adrenal crisis, further investigations should be considered including laboratory and imaging assessment. 
Če so prisotni znaki insuficience nadledvične žleze, vendar pa bolnik ni v adrenalni krizi, je treba razmisliti o nadaljnjih preiskavah, vključno z laboratorijskimi in slikovnimi.
Date of first authorisation: 13 July 2011 Date of latest renewal: 21 April 2016 
Datum zadnjega podaljšanja: 21. april 2016
In clinical trials, patients received up to 20 mg/kg without apparent toxic effects. 
V kliničnih preskušanjih so bolniki zdravilo prejemali v odmerkih do 20 mg/kg brez očitnih toksičnih učinkov.
Median duration of responseg 
Mediana trajanja odzivag
Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis. 
Pripravo raztopine za infundiranje mora izvesti ustrezno usposobljena oseba v skladu s pravili dobre prakse, še posebej glede aseptičnih pogojev.
Appropriate hormone replacement should also be initiated. 
Začeti je treba tudi z ustreznim nadomeščanjem hormonov.
• Obligation to conduct post-authorisation measure 
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
There are no data on the use of ipilimumab in pregnant women. 
Podatkov o uporabi ipilimumaba pri nosečnicah ni.
Tapering should occur over a period of at least 1 month. 
Odmerek je treba zmanjševati v obdobju vsaj enega meseca.
Long-term hormone replacement therapy may be necessary. 
Morda bo potrebno dolgotrajno hormonsko nadomestno zdravljenje.
As the subgroups analysis includes only small numbers of patients, no definitive conclusions can be drawn from these data. 
Ker je analiza po podskupinah vključevala le manjše število bolnikov, iz teh podatkov ni mogoče podati zanesljivih zaključkov.
Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 United States 
Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 Združene države Amerike
14 months 
14 mesecev
The majority had received all 4 doses during induction. 
Večina bolnikov je med indukcijo prejela vse 4 odmerke.
Rare proteinuriad 
Redki proteinurijad
if you are taking any medicines that stop your blood from clotting (anticoagulants). 
če jemljete katero koli zdravilo za preprečevanje nastanka krvnih strdkov (antikoagulanti).
No. at Risk mg/kg 965 429 127 73 41 29 28 12 8 4 0 
Št. ogroženih oseb mg/kg 965 429 127 73 41 29 28 12 8 4 0
The development or maintenance of clinical activity following ipilimumab treatment was similar with or without the use of systemic corticosteroids. 
Razvoj in vzdrževanje klinične aktivnosti po zdravljenju z ipilimumabom je bil podoben ob uporabi sistemskih kortikosteroidov ali brez.
The primary endpoints were safety and pharmacokinetics (PK). 
Primarna opazovana dogodka sta bila varnost in farmakokinetika.
You should not be given YERVOY if you are allergic to ipilimumab or any of the other ingredients of this medicine (listed in Section 6 "Contents of the pack and other information"). 
Zdravila YERVOY ne smete prejeti če ste alergični na ipilimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6 "Vsebina pakiranja in dodatne informacije").
YERVOY should not be frozen. 
Zdravila YERVOY ne smete zamrzovati.
Key elements for the Patient Information Brochure and Alert Card: 
Ključni elementi vodnika z informacijami za bolnike in opozorilne kartice:
Because of the limited number of patients in these analyses, no definitive conclusion regarding the efficacy of ipilimumab re-treatment can be drawn. 
Zaradi majhnega števila bolnikov, vključenih v te analize, dokončnih zaključkov o učinkovitosti ipilimumaba pri ponovnem zdravljenju ni mogoče podati.
Symptomatic treatment (e.g. loperamide, fluid replacement) and close monitoring are advised. 
Priporočljivo je simptomatsko zdravljenje (npr. loperamid, nadomeščanje tekočine) in skrben nadzor.
The effects of ipilimumab on prenatal and postnatal development were investigated in a study in cynomolgus monkeys. 
Vpliv ipilimumaba na prenatalni in postnatalni razvoj so raziskovali v študiji pri opicah cynomolgus.
What you need to know before you use YERVOY 3. 
Kaj morate vedeti, preden boste uporabili zdravilo YERVOY 3.
Additional information about these potentially inflammatory adverse reactions is provided in “Description of selected adverse reactions” and section 4.4. 
Dodatne informacije o teh potencialno vnetnih neželenih učinkih so na voljo v poglavju »Opis izbranih neželenih učinkov« in v poglavju 4.4.
What YERVOY is and what it is used for 2. 
Kaj je zdravilo YERVOY in za kaj ga uporabljamo 2.
However, for women above 50 years of age, the data supporting an OS benefit of ipilimumab treatment were limited. 
Pri ženskah, starejših od 50 let, pa je podatkov, ki podpirajo korist zdravljenja z ipilimumabom na celokupno preživetje, malo.
Severe or life-threatening adverse reactions 
Hudi ali življenjsko nevarni neželeni učinki
Overall Survival (proportion) 
Celokupno preživetje (delež)
loosening of membrane at the back of the eye (serous retinal detachment) 
odstopanje membrane na zadnji strani očesa (serozni odstop mrežnice)
Patients with cardiac or cardio-pulmonary symptoms should be assessed for potential myocarditis. 
Bolnike s srčnimi ali srčno-pljučnimi simptomi je treba ovrednotiti glede možnega miokarditisa.
- Inflammation or problems with your kidneys. 
- vnetje ali težave z ledvicami.
Until administration of all 4 doses or 16 weeks from first dose, whichever occurs earlier. 
Do aplikacije vseh 4 odmerkov ali 16 tednov od prvega odmerka, karkoli nastopi prej.
Advanced Melanoma and NonMelanoma Solid Tumors 
Napredovali melanom in nemelanomski solidni tumorji
How to use YERVOY 4. 
Kako uporabljati zdravilo YERVOY 4.
A summary of adverse events in adolescents 12 years of age and older, as well as adults, is presented in Table 7. 
Povzetek neželenih učinkov pri mladostnikih, starih 12 let in starejših, in odraslih je prikazan v preglednici 7.
Thus, the effect of ipilimumab on male and female fertility is unknown. 
Učinek ipilimumaba na plodnost pri moških in ženskah ni znan.
- Problems with your lungs such as breathing difficulties or cough. 
- težave s pljuči, kot so težave z dihanjem ali kašelj.
Fertility studies have not been performed. 
Študije vplivov na plodnost niso bile izvedene.
Early diagnosis and appropriate management are essential to minimise life-threatening complications. 
Zgodnje odkritje in ustrezno ukrepanje sta nujna za zmanjšanje pojavnosti življenjsko nevarnih zapletov.
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); very rare (< 1/10,000), not known (cannot be estimated from available post-marketing data). 
Pogostnost je opredeljena 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); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Patients were enrolled regardless of their baseline BRAF mutation status. 
Bolniki so bili vključeni ne glede na status mutacije BRAF.
Median time to response Months (range) 
Mediana časa do odziva Meseci (razpon)
Adrenal crisis as a cause of the patient's symptoms must be excluded. 
Pri bolniku je kot vzrok simptomov treba izključiti adrenalno krizo.
CTLA-4 blockade can also reduce T-regulatory cell function, which may contribute to an anti-tumour immune response. 
Z zavrtjem CTLA-4 se lahko zmanjša tudi regulatorna funkcija celic T, kar lahko prispeva k protitumorskemu imunskemu odzivu.
Neutralising antibodies against ipilimumab ranged from 0 to 0.3%. 
Pojavnost nevtralizirajočih protiteles proti ipilimumabu je bila v razponu od 0 % do 0,3 %.
More than one vial may be necessary to obtain the required dose. 
Za potreben odmerek bo morda treba uporabiti več kot eno vialo.
Exposures in adolescents are comparable with those in adults receiving the same mg/kg dose. 
Pri mladostnikih je bila izpostavljenost primerljiva z izpostavljenostjo pri odraslih, ki so prejemali enak odmerek v mg/kg.
- problems with your heart such as a change in the rhythm or rate of the heartbeat or an abnormal heart rythm. 
- težave s srcem, kot so spremembe ritma ali hitrosti utripanja srca ali nenormalen srčni ritem.
No other endocrine abnormalities were reported. 
O drugih endokrinih nepravilnostih niso poročali.
Attribution to ipilimumab reported as Possible, Probable, Definite, or Missing for CA184178 and Adult Safety Pool, and Related or Missing for CA184070. 
Atributi za ipilimumab so navedeni kot možni, verjetni, določni ali manjkajoči za študijo CA184178 in združene podatke o varnosti pri odraslih ter povezani ali manjkajoči za študijo CA184070.