natgillin/translations-raw huggingface dataset:
SOMAVERT 10 mg powder and solvent for solution for injection One vial contains 10 mg of pegvisomant. 
SOMAVERT 10 mg prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 10 mg pegvisomanta.
Disodium phosphate anhydrous Sodium dihydrogen phosphate monohydrate 
glicin manitol (E421) brezvodni natrijev hidrogenfosfat natrijev dihidrogenfosfat monohidrat
• Constipation, feeling sick, being sick, feeling bloated, indigestion, gas. 
• zaprtje, slabost, bruhanje, napihnjenost, prebavne motnje, vetrovi
After reconstitution, 1 ml of solution contains 30 mg of pegvisomant. 
Po pripravi z 1 ml vehikla vsebuje 1 ml raztopine 30 mg pegvisomanta.
After reconstitution, 1 ml of solution contains 20 mg of pegvisomant. 
Po pripravi z 1 ml vehikla vsebuje 1 ml raztopine 20 mg pegvisomanta.
After reconstitution, 1 ml of solution contains 25 mg of pegvisomant. 
Po pripravi z 1 ml vehikla vsebuje 1 ml raztopine 25 mg pegvisomanta.
Excipient with known effect The 10 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder. 
Ena viala zdravila z jakostjo 10 mg vsebuje 0,4 mg natrija.
Excipient with known effect: The 20 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder. 
Ena viala zdravila z jakostjo 20 mg vsebuje 0,4 mg natrija.
Do not use SOMAVERT: 
Ne uporabljajte zdravila Somavert, če se je spenilo.
SOMAVERT 20 mg powder for injection pegvisomant SC 
SOMAVERT 20 mg prašek za injiciranje pegvisomant s.c.
After reconstitution, 1 ml of solution contains 15 mg of pegvisomant. 
Po pripravi z 1 ml vehikla vsebuje 1 ml raztopine 15 mg pegvisomanta.
After reconstitution, 1 ml of solution contains 10 mg of pegvisomant. 
Po pripravi z 1 ml vehikla vsebuje 1 ml raztopine 10 mg pegvisomanta.
SOMAVERT 25 mg powder for injection pegvisomant SC 
SOMAVERT 25 mg prašek za injiciranje pegvisomant s.c.
SOMAVERT 20 mg powder for solution for injection pegvisomant 
SOMAVERT 20 mg prašek za raztopino za injiciranje pegvisomant
SOMAVERT 25 mg powder for solution for injection pegvisomant 
SOMAVERT 25 mg prašek za raztopino za injiciranje pegvisomant
SOMAVERT 30 mg powder for injection pegvisomant SC 
SOMAVERT 30 mg prašek za injiciranje pegvisomant s.c.
SOMAVERT 30 mg powder for solution for injection pegvisomant 
SOMAVERT 30 mg prašek za raztopino za injiciranje pegvisomant
Remove vial cap 
Zavrzite klik
asthenia, pyrexia a see Description of selected adverse reactions below b ADR related to hypersensitivity reaction 
gripi podobna bolezen, utrujenost, astenija, pireksija nenormalno počutje, slabše celjenje, lakota glejte »Opis izbranih neželenih učinkov«, spodaj neželeni učinki, povezani s preobčutljivostno reakcijo
SOMAVERT 10 mg powder for solution for injection pegvisomant 
SOMAVERT 10 mg prašek za raztopino za injiciranje pegvisomant
Powder and solvent for solution for injection 1 vial of powder 
prašek in vehikel za raztopino za injiciranje
SOMAVERT 10 mg powder for injection pegvisomant SC 
SOMAVERT 10 mg prašek za injiciranje pegvisomant s.c.
SOMAVERT 15 mg powder for solution for injection pegvisomant 
SOMAVERT 15 mg prašek za raztopino za injiciranje pegvisomant
SOMAVERT 15 mg powder for injection pegvisomant SC 
SOMAVERT 15 mg prašek za injiciranje pegvisomant s.c.
1 ml of solvent, 1 ml of the solution contains 25 mg pegvisomant. 
1 ml pripravljene raztopine vsebuje 25 mg pegvisomanta.
You may need to read it again - If you have any further questions, ask your doctor, pharmacist or nurse. 
• Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
1 ml of solvent, 1 ml of the solution contains 20 mg pegvisomant. 
1 ml pripravljene raztopine vsebuje 20 mg pegvisomanta.
1 ml of solvent, 1 ml of the solution contains 30 mg pegvisomant. 
1 ml pripravljene raztopine vsebuje 30 mg pegvisomanta.
1 ml of solvent, 1 ml of the solution contains 15 mg pegvisomant. 
1 ml pripravljene raztopine vsebuje 15 mg pegvisomanta.
Make needle safe 
Zavarujte iglo
SOMAVERT 20 mg powder and solvent for solution for injection pegvisomant 
SOMAVERT 20 mg prašek in vehikel za raztopino za injiciranje pegvisomant
The powder is white to slightly off-white. 
Prašek je bel do belkast.
1 ml of solvent, 1 ml of the solution contains 10 mg pegvisomant. 
1 ml pripravljene raztopine vsebuje 10 mg pegvisomanta.
SOMAVERT 10 mg powder and solvent for solution for injection pegvisomant 
SOMAVERT 10 mg prašek in vehikel za raztopino za injiciranje pegvisomant
SOMAVERT 30 mg powder and solvent for solution for injection pegvisomant 
SOMAVERT 30 mg prašek in vehikel za raztopino za injiciranje pegvisomant
SOMAVERT 25 mg powder and solvent for solution for injection pegvisomant 
SOMAVERT 25 mg prašek in vehikel za raztopino za injiciranje pegvisomant
Note: Make sure you keep the needle in at full depth. 
• Opomba: Igla naj ostane do konca zabodena v kožo.
SOMAVERT 15 mg powder and solvent for solution for injection pegvisomant 
SOMAVERT 15 mg prašek in vehikel za raztopino za injiciranje pegvisomant
Breast-feeding 
urtikarija angioedem
2132NP Hoofddorp Netherlands 
2132 NP Hoofddorp Nizozemska
Response in skin and blood was evaluated every 4 weeks. 
Odziv kože in krvi so ovrednotili vsake 4 tedne.
Disease stage IB/II 
Stadij bolezni IB/II
As with all therapeutic proteins, there is a potential for immunogenicity. 
Kot pri vseh terapevtskih proteinih obstaja možnost imunogenosti.
TLS was observed most frequently during the first month of treatment. 
TLS so najpogosteje opazili v prvem mesecu zdravljenja.
Each arm enrolled 186 patients. 
V vsaki skupini je bilo 186 bolnikov.
The majority of patients recovered from infection. 
Večina bolnikov je po okužbi okrevala.
• Each vial is for single use only. 
• Vsaka viala je samo za enkratno uporabo.
- have heart problems. 
- če imate težave s srcem.
100-1 Hagiwara-machi, Takasaki-shi, Gunma, 370-0013, Japan 
100-1 Hagiwara-machi, Takasaki-shi Gunma, 370-0013, Japonska
This medicine should not be used in children and adolescents below 18 years of age. 
To zdravilo se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Blood (n) 
Kri (n)
However, the medicine can cause tiredness in some people, so take particular care when driving and using machines until you are certain that this medicine does not affect you. 
Vendar lahko to zdravilo pri nekaterih ljudeh povzroča utrujenost, zato bodite posebno previdni pri vožnji in uporabi strojev, dokler niste prepričani, da pri vas nima takšnega učinka.
- have had or plan to have a stem cell transplant, either using your own cells or a donor's. 
- če ste imeli ali načrtujete presaditev matičnih celic, bodisi z uporabo lastnih celic bodisi celic darovalca;
Patients who have risk factors associated with cardiac disease should be monitored and appropriate precautions taken. 
Bolnike, ki imajo dejavnike tveganja, povezane z boleznimi srca, je treba spremljati in uvesti ustrezne previdnostne ukrepe.
a: P-value was obtained from Cochran-Mantel-Haenszel test adjusting for disease type, disease stage, and region. 
a: Vrednost P je bila pridobljena s testom Cochran-Mantel-Haenszel, prilagojenim za tip bolezni, stadij bolezni in območje.
Note: Overall response rate is based on Global Composite Response score. 
Opomba: Skupna stopnja odziva temelji na globalnem sestavljenem odzivu.
The amount of POTELIGEO you will receive is calculated by your doctor based on your body weight. 
Količino zdravila POTELIGEO, ki jo boste prejeli, bo izračunal zdravnik glede na vašo telesno maso.
Although unlikely to be caused by this medicine, these may be signs of a heart disorder. 
Čeprav je maloverjetno, da gre za učinek tega zdravila, so to lahko znaki bolezni srca;
Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period. 
Znano je, da se človeški IgG izločajo z materinim mlekom v prvih nekaj dneh po porodu, čeprav se kmalu zatem koncentracije zelo znižajo; v tem kratkem obdobju ni mogoče izključiti tveganja za dojenega otroka.
United Kingdom allphamed PHARBIL Arzneimittel GmbH Hildebrandstr. 
Združeno kraljestvo allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
Patients should be monitored closely by appropriate laboratory and clinical tests for electrolyte status, hydration and renal function, particularly in the first month of treatment, and managed according to best medical practice. 
Bolnike je treba pozorno spremljati z ustreznimi laboratorijskimi in kliničnimi preiskavami za stanje elektrolitov, hidracije in delovanja ledvic, zlasti v prvem mesecu zdravljenja, in jih obravnavati skladno z najboljšo medicinsko prakso.
If a compartment level response or overall response is not observed after 3 months of treatment, discontinuation of treatment should be considered. 
Če po 3 mesecih zdravljenja ni opaziti odziva na ravni telesnega predela ali skupnega odziva, je treba razmisliti o prekinitvi zdravljenja.
There were no positive neutralising antibody responses. 
Pozitivnih odzivov nevtralizirajočih protiteles ni bilo.
Severe reactions (Grade 3) were experienced by 4% of patients. 
Hude reakcije (3. stopnje) so se pojavile pri 4 % bolnikov.
Do not use this medicine if you notice signs of deterioration, such as particulate matter or discolouration. 
Ne uporabljajte tega zdravila, če opazite znake deterioracije (poslabšanja), kot sta prisotnost delcev ali obarvanost.
If this happens, the infusion may need to be stopped and you may require additional treatment. 
Če se to zgodi, bo morda treba ustaviti prejemanje tega zdravila in morda boste potrebovali dodatno zdravljenje.
Patients should be monitored for signs and symptoms of infection and treated promptly. 
Bolnike je treba spremljati glede znakov in simptomov okužbe ter jih takoj zdraviti.
The safety profile observed in the 90 days following the last dose of mogamulizumab is consistent with the safety profile observed during the study treatment period. 
Varnostni profil, ugotovljen v 90 dneh po zadnjem odmerku mogamulizumaba, je skladen z varnostnim profilom, opaženim med zdravljenjem v okviru študije.
Table 2: Response during randomised treatment period in study 0761-010 (intent-to-treat) 
Preglednica 2: odziv med randomiziranim obdobjem zdravljenja v študiji 0761-010 (namen zdravljenja)
Linearity and accumulation 
Linearnost in kopičenje
On a power model analysis, no deviation from dose proportionality was evident. 
Pri analizi modela moči ni bilo opaziti nikakršnega odstopanja od sorazmernosti z odmerkom.
Serious infections, including sepsis, pneumonia and skin infections, were experienced by 14.3% of subjects receiving mogamulizumab. 
Resne okužbe, vključno s sepso, pljučnico in kožnimi okužbami, so se pojavile pri 14,3 % bolnikov, ki so prejemali mogamulizumab.
Time to compartment level response in Stage IB/II patients was approximately 3 months, which is consistent with time to response for the ITT population overall (approximately 3 months). 
Čas do odziva na ravni telesnega predela pri bolnikih s stadijem IB/II je bil približno 3 mesece, kar se ujema s časom do odziva pri celotni populaciji ITT (približno 3 mesece).
Do not use this medicine after the expiry date which is stated on the carton and the vial after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake »EXP«.
- if you go on to have a stem cell transplant, it is possible that you could then develop complications (graft versus host disease) that are difficult to manage. 
- če imate presaditev matičnih celic, se lahko razvijejo zapleti (bolezen presadka proti gostitelju), ki jih je težko obvladati.
Table 3: Overall and Compartmental Response Rate in Early Disease Stages 
Preglednica 3: splošna stopnja odziva in stopnja odziva po telesnih predelih v zgodnjih stadijih bolezni
If a dose is missed by more than 2 days, the next dose should be administered as soon as possible, after which the dosing schedule should be resumed with doses given based on the new scheduled days. 
Če se z odmerkom zamudi za več kot 2 dni, je treba naslednji odmerek uporabiti čim prej, nato pa je treba časovni načrt odmerjanja nadaljevati na novo določene dneve.
Afterwards POTELIGEO could be used during breast-feeding if clinically needed. 
Pozneje se zdravilo POTELIGEO lahko uporablja med dojenjem, če je to klinično potrebno.
CI=confidence interval; CR=complete response; PR=partial response 
IZ = interval zaupanja; PO = popoln odziv; DO = delni odziv.
No specific studies have been conducted to evaluate potential effects on fertility. 
Specifičnih študij za oceno morebitnih učinkov na plodnost niso izvedli.
Due to the mechanism of action of the medicine, it may harm your baby if it is administered when you are pregnant or breast- feeding. 
Zaradi mehanizma delovanja lahko to zdravilo škoduje otroku, če ga uporabljate, ko ste noseči ali dojite.
Patients should be closely monitored for symptoms or signs that suggest SJS or TEN. 
Bolnike je treba pozorno spremljati zaradi simptomov ali znakov, ki kažejo na SJS ali TEN.
The subjects had a medical history including various risk factors. 
Anamneza preskušancev je vključevala različne dejavnike tveganja.
The median duration of exposure with mogamulizumab was 5.6 months (range: <1 to 45.3 months). 
Mediano trajanje izpostavljenosti mogamulizumabu je bilo 5,6 meseca (razpon: od < 1 do 45,3 meseca).
In case of overdose, the patient, including their vital signs, should be closely monitored (for at least 1 hour) and supportive treatment should be administered if required. 
Če pride do prevelikega odmerjanja, je treba bolnika pozorno spremljati, vključno z vitalnimi znaki (najmanj 1 uro), in po potrebi uvesti podporno zdravljenje.
At study baseline, 38% had stage IB-II disease, 10% stage III, 52% stage IV. 
Ob izhodišču študije je 38 % bolnikov imelo stadij bolezni IB-II, 10 % stadij III in 52 % stadij IV.
Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (at 25°C) under ambient room light. 
Dokazano je, da je raztopina kemijsko in fizikalno stabilna 24 ur, če se hrani pri sobni temperaturi (25 °C) in na sobni svetlobi.
Table 4: Progression Free Survival (PFS) by Treatment Group and Disease Stage (Randomised Treatment Period) 
Preglednica 4: Preživetje brez napredovanja bolezni (PFS) glede na zdravljeno skupino in stadij bolezni (randomizirano obdobje zdravljenja)
This study included patients regardless of their baseline level of CCR4 expression in skin biopsy. 
Ta študija je vključevala bolnike ne glede na izhodiščno raven izraženosti CCR4 pri kožni biopsiji.
These time limits include storage of the infusion solution in the infusion bag through the duration of infusion. 
Ta časovna omejitev vključuje shranjevanje raztopine za infundiranje v infuzijski vrečki med infundiranjem.
• The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags. 
• Razredčena raztopina je združljiva z infuzijskimi vrečkami iz polivinilklorida (PVC) ali poliolefina (PO).
The population PK analysis included 444 patients receiving mogamulizumab in six clinical trials. 
Analiza populacijske FK je vključevala 444 bolnikov, ki so prejemali mogamulizumab v 6 kliničnih preskušanjih.
Discard any unused portion left in the vial in accordance with local requirements. 
Morebitno neporabljeno vsebino viale je treba zavreči skladno z lokalnimi predpisi.
The effects of POTELIGEO in pregnancy and breast-feeding are not known. 
Učinki zdravila POTELIGEO med nosečnostjo in dojenjem niso znani.
Once opened, the medicinal product should be diluted and infused immediately (see section 6.6). 
Po odprtju je treba zdravilo takoj razredčiti in infundirati (glejte poglavje 6.6).
The most frequently reported serious adverse reactions were pneumonia, pyrexia, infusion related reaction and cellulitis. 
Resni neželeni učinki, o katerih so najpogosteje poročali, so bili pljučnica, pireksija, z infuzijo povezana reakcija in celulitis.
- allergic to mogamulizumab or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na mogamulizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Safety post last dose 
Varnost po zadnjem odmerku
The destruction of cancer cells and the body's reaction to it can very occasionally lead to a problem called tumour lysis syndrome. 
Uničenje rakavih celic in reakcija telesa na to lahko v redkejših primerih povzroči težavo, ki se imenuje sindrom tumorske lize;
To start with, the infusions will be given once a week for the first 5 doses, then once every 2 weeks. 
Na začetku boste prvih 5 odmerkov dobili enkrat na teden, pozneje pa boste dobivali infuzije enkrat na 2 tedna.
Infusion-related reactions have been observed in 33% of patients treated with POTELIGEO. 
Reakcije, povezane z infundiranjem, so opazili pri 33 % bolnikov, zdravljenih z zdravilom POTELIGEO.
The medicine is for use in patients who have received at least one medicine given by mouth or by injection. 
Zdravilo je namenjeno uporabi pri bolnikih, ki so predhodno prejeli vsaj eno zdravilo peroralno (skozi usta) ali z injekcijo.
Patients with rapidly proliferating tumour and high tumour burden are at risk of TLS. 
Pri bolnikih, ki imajo tumor s hitro proliferacijo in veliko tumorsko breme, obstaja tveganje za TLS.
The IRRs were mostly mild or moderate in severity, although there have been a few reports of severe reactions (Grade 3). 
Te reakcije so bile večinoma blage ali zmerne, vendar so poročali tudi o nekaj hudih reakcijah (3. stopnja).
A higher risk of transplant complications has been reported if mogamulizumab is given within a short time frame (approximately 50 days) before HSCT. 
Poročali so o večjem tveganju za zaplete pri presaditvi, če je mogamulizumab dan nedolgo (približno 50 dni) pred HSCT.
Mogamulizumab is dosed via intravenous route and therefore is immediately and completely bioavailable. 
Mogamulizumab se daje po intravenski poti, zato je njegova biološka uporabnost takojšnja in popolna.
The final concentration of the diluted solution should be between 0.1 mg/mL to 3.0 mg/mL. 
Končna koncentracija razredčene raztopine mora biti med 0,1 mg/ml in 3,0 mg/ml.
Overall response was reported as a composite score from measures in each compartment, and a response had to be demonstrated at two successive overall disease assessments (at least 8 weeks apart during the first year and 16 weeks apart thereafter) in order to be confirmed. 
Skupni odziv je bil poročan kot sestavljen rezultat po merilih za vsak telesni predel in odziv je moral biti za potrditev dokazan pri dveh zaporednih splošnih ocenah bolezni (s presledkom najmanj 8 tednov v prvem letu in pozneje 16 tednov).
Large cell transformation (LCT) There are limited data available on patients with LCT. 
Transformacija velikih celic (LCT) O bolnikih z LCT je na voljo malo podatkov.
• Administer infusion solution over at least 60 minutes through an intravenous line containing a sterile, low protein binding 0.22 micron (or equivalent) in-line filter. 
• Raztopino za infundiranje je treba dajati najmanj 60 minut skozi intravensko linijo s sterilnim 0,22-mikronskim (ali enakovrednim) linijskim filtrom, ki malo veže proteine.
Treatment should be continued unless you get serious side effects or the cutaneous T-cell lymphoma starts to get worse. 
Zdravljenje je treba nadaljevati, razen če se pojavijo resni neželeni učinki ali se kožni T-celični limfom poslabša.
The study demonstrated statistically significant improvements in ORR and response by compartment in the blood, skin, and lymph nodes as compared to vorinostat. 
Študija je pokazala statistično pomembne izboljšave v SSO in odzivu po telesnih predelih za kri, kožo in bezgavke v primerjavi z vorinostatom.
The safety and efficacy of POTELIGEO in children and adolescents aged below 18 years has not been established. 
Pediatrična populacija Varnost in učinkovitost zdravila POTELIGEO pri otrocih in mladostnikih, mlajših od 18 let, nista dokazani.
Exposure-Response analysis indicated that efficacy was not correlated with mogamulizumab exposure in the pivotal study. 
Analiza izpostavljenost-odziv je pokazala, da učinkovitost ni bila v korelaciji z izpostavljenostjo mogamulizumabu v ključni študiji.
The primary efficacy endpoint was progression-free survival (PFS) based on investigator assessment using a global composite response criteria that took into account all potentially affected disease compartments (skin, blood, lymph nodes and viscera). 
Primarni opazovani dogodek učinkovitosti je bilo preživetje brez napredovanja bolezni (PFS) na podlagi ocene raziskovalca z uporabo globalnih sestavljenih meril odziva, v katerih so upoštevani vsi telesni predeli, ki jih bolezen lahko prizadene (koža, kri, bezgavke in drobovje).
- Lack of energy (fatigue) - Constipation - Swollen legs or ankles - Headache 
- pomanjkanje energije (utrujenost) - zaprtost - otečene noge ali gležnji - glavobol
Efficacy, as measured by improvement in PFS based on investigator assessment, was not associated with increasing mogamulizumab exposure. 
Učinkovitost, merjena z izboljšanjem preživetja brez napredovanja bolezni na podlagi ocene raziskovalca, ni bila povezana s povečano izpostavljenostjo mogamulizumabu.
Reasons for crossover to mogamulizumab were disease progression (109 patients) and treatment intolerance (27 patients). 
Razloga za prehod na mogamulizumab sta bila napredovanje bolezni (109 bolnikov) in nezmožnost prenašanja zdravljenja (27 bolnikov).
• Calculate the required volume of POTELIGEO needed to prepare the infusion solution for the 1 mg/kg dosage based on patient weight (see section 4.2). 
• Izračunajte količino zdravila POTELIGEO, ki je potrebna za pripravo raztopine za infundiranje za odmerek 1 mg/kg, glede na telesno maso bolnika (glejte poglavje 4.2).
56% of patients received mogamulizumab for at least 6 cycles, and 25% of patients received mogamulizumab for at least 12 cycles. 
56 % bolnikov je prejelo najmanj 6 krogov zdravljenja z mogamulizumabom in 25 % bolnikov je prejelo najmanj 12 krogov zdravljenja z mogamulizumabom.
Contents of the pack and other information What POTELIGEO contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo POTELIGEO
The combination of mogamulizumab with systemic immune modulating medicinal products or with other licensed therapies for MF or SS has not been studied and is, therefore, not recommended, especially in consideration of the risk of severe infections in patients treated with mogamulizumab. 
Kombinacij mogamulizumaba s sistemskimi imunomodulirajočimi zdravili ali drugimi odobrenimi zdravili za zdravljenje FM ali SS niso preučili in zato niso priporočljive, zlasti ob upoštevanju tveganja za pojav resnih okužb pri bolnikih, ki se zdravijo z mogamulizumabom.
Figure 1: Plot of Kaplan-Meier curve of progression-free survival by investigator's assessment (ITT) population 
Slika 1: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po oceni raziskovalca - populacija ITT
- Inflammation of the liver (hepatitis) 
- vnetje jeter (hepatitis)
Mogamulizumab is produced in Chinese hamster ovary cells by recombinant DNA technology. 
Mogamulizumab je pridobljen iz ovarijskih celic kitajskega hrčka s tehnologijo rekombinantne DNK.
Patients were included in the analysis for a specific compartment if they had presence of disease in that compartment at baseline, or had any post-baseline response assessment for that compartment. 
Bolniki so bili vključeni v analizo za določen telesni predel, če so ob izhodišču imeli bolezen na tem predelu ali če so imeli po izhodišču kakršno koli oceno odziva na tem predelu.
If reaction recurs, discontinuing the infusion should be considered (see section 4.4). 
Če se reakcija ponovi, je treba razmisliti o opustitvi infundiranja (glejte poglavje 4.4).
There are limited efficacy data in patients with low (<10%) CCR4 expression in the skin. 
Podatki o učinkovitosti pri bolnikih z nizko (< 10 %) izraženostjo CCR4 v koži so omejeni.