natgillin/translations-raw huggingface dataset:
Note: Treatment failure at or after week 6 (Study UV I), or at or after week 2 (Study UV II), was counted as event.
Opomba: Neuspeh zdravljenja v ali po 6. tednu (študija UV I) ali v ali po 2. tednu (študija UV II) je bil štet kot dogodek.
If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Cyltezo, and in accordance with local recommendations.
Če ugotovite latentno tuberkulozo, morate pred uvedbo zdravila Cyltezo začeti s protituberkuloznim profilaktičnim zdravljenjem v skladu z lokalnimi priporočili.
They are displayed by system organ class and frequency in Table 6 below: 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); and not known (cannot be estimated from the available data).
Naslednji seznam neželenih učinkov je osnovan na izkušnjah iz kliničnih preskušanj in iz obdobja trženja zdravila in jih razvršča po organskih sistemih in pogostnosti v preglednici 6 spodaj: 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) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Cyltezo can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Zdravilo Cyltezo je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
Should treatment be interrupted, Cyltezo may be re-introduced as appropriate.
Če je treba zdravljenje prekiniti, je možno zdravljenje z zdravilom Cyltezo znova uvesti, kakor je primerno.
N Failure N (%)
ODSTOTEK NEUSPEHA ZDRAVLJENJA (%)
If you use more Cyltezo than you should
Če ste uporabili večji odmerek zdravila Cyltezo, kot bi smeli
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Cyltezo should be discontinued immediately and appropriate therapy initiated.
Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo zdravila Cyltezo nemudoma prekiniti in uvesti ustrezno zdravljenje.
Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84%) patients in the adalimumab group who remained in the study.
Izboljšanje v številu aktivnih sklepov z artritisom se je ohranilo v obdobju odprtega preskušanja po 156. tednu za 26 od 31 (84 %) bolnikov v skupini bolnikov, ki je prejemala adalimumab, ki so ostali v študiji.
PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 µg/mL (95 % CI 0.4-47.6 and 1.9-10.5, respectively).
PASI 75 in PGA čisto ali minimalno, sta se povečevali z zvečanjem koncentracije adalimumaba, obe s podobno navidezno EC50, za približno 4,5 μg/ml (95% IZ 0,4-47,6 in 1,9-10,5).
Adalimumabcan be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Adalimumab je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno (za učinkovitost monoterapije glejte poglavje 5.1).
In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Cyltezo.
V primeru neinfekcijskega uveitisa se kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem, lahko še nadalje uporabljajo ob uporabi zdravila Cyltezo.
• sensation disorders such as tingling, prickling or numbness; • symptoms of nerve root compression (including low back pain and leg pain);
• motnje v občutenju kot so ščemenje, zbadanje ali omrtvelost; • simptomi stisnenja živčnih korenin (vključno z bolečino v spodnjem delu hrbta in nogah);
What Cyltezo is and what it is used for Cyltezo contains the active substance adalimumab, a medicine that acts on your body's immune (defence)
Kaj je zdravilo Cyltezo in za kaj ga uporabljamo Zdravilo Cyltezo vsebuje učinkovino adalimumab, učinkovino, ki deluje na imunski (obrambni)
Consequently, Cyltezo can be used during breastfeeding.
Posledično se zdravilo Cyltezo lahko uporablja med dojenjem.
Adalimumab was studied in 9,506 patients in pivotal controlled and open-label trials for up to 60 months or more.
Adalimumab so raziskali pri 9.506 bolnikih v ključnih kontroliranih in odprtih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet in so trajala do 60 mesecev ali več.
• nerve disorders (such as inflammation of the optic nerve to the eye and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• bolezni živčevja (kot je vnetje vidnega živca v očesu in sindrom Guillain-Barré, stanje, ki lahko povzroči šibkost mišic, nenormalna občutenja, mravljinčenje v rokah in zgornjem delu telesa);
Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Adalimumab je rekombinantno humano monoklonsko protitelo, pridobljeno v celicah jajčnika
Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10% (60 % of patients) and BSA < 10 % and ≥ 5 % (40 % of patients)).
Adalimumab je pokazal terapevtsko korist pri bolnikih s psoriazo nohtov z različnim obsegom prizadetosti kože (telesna površina ≥ 10 % (60 % bolnikov) in telesna površina < 10 % in ≥ 5 % (40 % bolnikov)).
Similar trends (not all statistically significant) were seen in the smaller randomised, double-blind, placebo-controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri ankilozirajočem spondilitisu II pri 82 odraslih bolnikih z
In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see Tables 17 and 18).
V študijah pri psoriazi I in II je bil primarni opazovani dogodek delež bolnikov, ki so od izhodišča do 16. tedna dosegli PASI 75 (glejte preglednici 17 in 18).
By attaching to TNFα, Cyltezo decreases the process of inflammation in these diseases.
Zdravilo Cyltezo z vezavo na TNFα zmanjša vnetni proces pri teh boleznih.
Some of those patients were also treated with the medicines azathioprine or mercaptopurine.
Nekateri od teh bolnikov so bili zdravljeni tudi z učinkovinama azatioprin ali merkaptopurin.
Cyltezo is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Zdravilo Cyltezo se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa pri otrocih in mladostnikih, starih 2 do 17 let in artritisa, povezanega z entezitisom pri otrocih in mladostnikih starih od 6 do 17 let.
The Cyltezo pre-filled pen is available in packs containing 1, 2, 4 and 6 pre-filled pens.
Napolnjeni injekcijski peresnik z zdravilom Cyltezo je na voljo v pakiranjih po 1, 2, 4 in 6 napolnjenih injekcijskih peresnikov.
• If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Cyltezo and contact your doctor immediately since, in rare cases, these reactions
• Če se pojavijo alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Cyltezo ne injicirajte več in se takoj posvetujte z zdravnikom, saj so v redkih primerih te reakcije lahko življenje ogrožajoče.
• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
• jetrnovranični T-celični limfom (redka oblika krvnega raka, ki je pogosto smrtna);
A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid
Za oceno so uporabili modificirani celotni seštevek po Sharpu (mTSS, modified Total Sharp Score), ki je vključil distalne interfalangealne sklepe (tj. ni bil enak TSS, ki se uporablja za revmatoidni artritis).
The symptoms described above can be signs of the below listed side effects, which have been observed with
Opisani simptomi so lahko znaki naslednjih neželenih učinkov, ugotovljenih med uporabo
If your doctor determines that methotrexate is inappropriate, Cyltezo can be given alone.
Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko zdravilo Cyltezo dobivate samo.
In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years.
V obdobju trženja od januarja 2003 do decembra 2010 je bil pretežno pri bolnikih z revmatoidnim artritisom zabeleženi delež malignomov približno 2,7 na 1.000 bolnikov-let zdravljenja.
Significant improvements at week 16 from baseline compared to placebo (Studies I and II) and MTX (Study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Značilno izboljšanje od izhodišča do 16. tedna se je v primerjavi s placebom (študiji I in II) in metotreksatom (študija II) izkazalo v dermatološkem indeksu kakovosti življenja (DLQI, Dermatology Life Quality Index).
In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
V kliničnem preskušanju z drugim antagonistom TNF so opažali poslabšanje kongestivnega srčnega popuščanja in večjo umrljivost zaradi kongestivnega srčnega popuščanja.
• Hold syringe at about a 45 degree angle to injection site, then insert needle into skin with a quick,
• Iglo držite pod kotom približno 45 stopinj glede na mesto injiciranja, nato jo hitro vbodite v
What you need to know before you use Cyltezo
Kaj morate vedeti, preden boste uporabili zdravilo Cyltezo
Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment.
Bolniki z vsaj delnim odzivom na odmerek 40 mg adalimumaba po 12. tednih zdravljenja.
• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).
• poslabšanje stanja, ki se imenuje dermatomiozitis (viden kot kožni izpuščaj, ki ga spremlja
This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e. essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 0,8 ml odmerek, kar v bistvu pomeni ‘brez
In all situations described below, the benefit/risk balance of therapy should be very carefully considered.
V vseh spodaj opisanih okoliščinah je treba korist in tveganje zdravljenja z zdravilom Cyltezo zelo
Of those patients who had a response at week 8, 47 % were in response, 29 % were in remission, 41 % had mucosal healing, and 20 % were in steroid-free remission for ≥ 90 days at week 52.
Od bolnikov, ki so bili odzivni v 8. tednu, jih je bilo v 52. tednu 47 % odzivnih, 29 % v remisiji, 41 % je imelo celjenje sluznice in 20 % jih je bilo v remisiji brez steroidov za ≥ 90 dni.
Improvement in quality of life was measured up to week 156 (36 months) and improvement was maintained through that time.
Do 156. tedna (36. meseca) se je ocenjevalo izboljšanje kvalitete življenja, ki se je v tem
Efficacy Results at 12 Weeks, HS Studies I and II HS Study I
Preglednica 21: Rezultati učinkovitosti v 12. tednu, HS študiji I in II
Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg/kg/day or 10 mg/day maximum).
Bolniki so ostali na stabilnih odmerkih nesteroidnih protivnetnih zdravil in/ali prednizona (≤ 0,2 mg/kg/dan ali največ 10 mg/dan).
• If needed, press cotton ball or gauze over injection site to stop any bleeding.
• Po potrebi na mesto injiciranja pritisnite tampon ali gazo, da zaustavite morebitno krvavitev.
Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3 % and at week 96 was 65.1 %.
Med bolniki, ki z vsaj delnim odzivom v 12. tednu, in ki so prejemali neprekinjeno tedensko terapijo adalimumaba vsak teden, je bila stopnja kliničnega odziva (HiSCR) v 48. tednu 68,3 % in v 96. tednu 65,1 %.
In patients who develop HBV reactivation, Cyltezo should be stopped and effective anti-viral therapy with appropriate supportive treatment should be
Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo zdravila Cyltezo prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim
Patients who develop a new infection while undergoing treatment with Cyltezo should be monitored closely and undergo a complete diagnostic evaluation.
Bolnike, pri katerih se med zdravljenjem z zdravilom Cyltezo pojavi nova okužba, je treba natančno nadzirati in opraviti morajo popolno diagnostično obravnavo.
In rheumatoid arthritis, methotrexate is continued while using Cyltezo.
Pri revmatoidnem artritisu se uporaba metotreksata med uporabo zdravila Cyltezo nadaljuje.
Kaplan-Meier Curves Summarizing Time to Treatment Failure on or after Week 6 (Study UV I) or Week 2 (Study UV II)
Kaplan-Meierjeve krivulje povzemajo čas do neuspeha zdravljenja v ali po 6. tednu (študija UV I) ali 2. tednu (študija UV II)
Antibiotics may be continued during treatment with Cyltezo if necessary.
Med zdravljenjem z zdravilom Cyltezo lahko nadaljujete z antibiotičnim zdravljenjem, če je potrebno.
You should record the date when the syringe is first removed from refrigerator and the date after which it
Zapisati si morate datum, ko je bila injekcijska brizga vzeta iz hladilnika in datum, po katerem jo je
The combination of Cyltezo and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Kombinacija zdravila Cyltezo in abatacepta ni priporočljiva (glejte poglavje 4.4 "Sočasna uporaba bioloških DMARDS ali antagonistov TNF").
Cyltezo is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Zdravilo Cyltezo se uporablja za zdravljenje hidradenitis suppurativa pri odraslih in mladostnikih, starejših od 12 let.
Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (see Table 29).
Rezultati iz obeh študij kažejo statistično značilno zmanjšanje tveganja za neuspeh zdravljenja pri bolnikih, ki so prejemali adalimumab, v primerjavi z bolniki, ki so prejemali placebo (glejte preglednico 29).
• If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Cyltezo.
• Če imate ali pa se pri vas razvija demielinizirajoča bolezen (bolezen, ki vpliva na izolativno plast okoli živcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko dobivate oziroma tudi še nadalje dobivate zdravilo Cyltezo.
• Use alcohol wipe to clean selected injection site.
• Z alkoholnim zložencem očistite izbrano mesto injiciranja.
Hepato-biliary events
Dogodki povezani s hepatobiliarnim sistemom
What Cyltezo looks like and contents of the pack
Izgled zdravila Cyltezo in vsebina pakiranja
• Relevant information on the safety concerns of serious infections, sepsis, tuberculosis and opportunistic infections; congestive heart failure; demyelinating disorders; malignancies to be addressed by the additional risk minimisation measures (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable).
• Pomembne informacije glede varnostnih vprašanj v povezavi z resnimi okužbami, sepso, tuberkulozo in oportunističnimi okužbami, kongestivnim srčnim popuščanjem, demielinizirajočimi boleznimi, malignostmi, ki jih je treba nasloviti z ukrepi za dodatno zmanjševanje tveganj (npr. resnost, intenzivnost, pogostnost, čas do začetka, reverzibilnost
Treatment failure was defined by a multi-component outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA).
Neuspeh zdravljenja je bil definiran z večkomponentnim izidom, ki je temeljil na vnetnih horioretinalnih in/ali vnetnih retinalnih vaskularnih lezijah, oceni celic sprednje očesne komore, motnosti steklovine in najboljši korigirani ostrini vida (BCVA, best corrected visual acuity).
The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9 % for patients taking adalimumab and 5.4 % for control treated
Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje med dvojno slepim, kontroliranim delom ključnih študij, ki podpirajo vlogo za pridobitev dovoljenja za promet, je bil 5,9 % v skupini, ki je prejemala adalimumab, in 5,4 % v kontrolni skupini.
• inflammation of the pancreas which causes severe pain in the abdomen and back;
• vnetje trebušne slinavke, ki povzroča hujšo bolečino v trebuhu in hrbtu;
Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased
pogosti motnje koagulacije in krvavenja (vključno s podaljšanim aktiviranim parcialnim tromboplastinskim časom), prisotnost avtoprotiteles (vključno s protitelesi proti dvovijačni DNA), zvišanje laktat dehidrogenaze v krvi
A single Cyltezo pre-filled syringe/pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Posamezna napolnjena injekcijska brizga/napolnjeni injekcijski peresnik z zdravilom Cyltezo se lahko shranjuje pri temperaturi največ do 25 ºC za obdobje do 14 dni.
• angioedema (localised swelling of the skin); • lichenoid skin reaction (itchy reddish-purple skin rash).
• angioedem (lokalizirano otekanje kože); • lihenoidna reakcija kože (srbeč rdeče-vijolični kožni izpuščaj).
Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin)
levkemija hepatosplenični T-celični limfom karcinom Merklovih celic (nevroendokrini karcinom kože)
Distribution of patients by age and adalimumab dose received during the OL LI phase
Porazdelitev bolnikov po starosti in odmerku adalimumaba, ki so ga dobivali med odprto uvajalno fazo Starostna skupina
Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0 % vs 11.4 %, respectively) and draining fistulas (30.0 % vs 13.9 %, respectively).
Približno dvakratni delež bolnikov v skupini, ki je prejemala placebo, je v primerjavi s tistimi, ki so bili v skupini z adalimumabom, je v prvih 12. tednih študije HS-I in HS-II, doživelo poslabšanje abscesov (23,0 % v primerjavi z 11,4 %, v tem zaporedju) in fistul z izcedkom (30,0 % v primerjavi s 13,9 %, v tem zaporedju).
Patients should be tested for HBV infection before initiating treatment with Cyltezo.
Bolnike je treba pred začetkom zdravljenja z zdravilom Cyltezo testirati na okužbo s HBV.
Of those in clinical response at week 4, 48 % had been previously exposed to other TNFantagonists.
Od tistih, ki so imeli 4. teden klinični odziv, jih je 48 % predhodno dobilo antagoniste TNF.
Treatment with Cyltezo may result in the formation of autoimmune antibodies.
Zdravljenje z zdravilom Cyltezo lahko povzroči nastanek avtoimunskih protiteles.
When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient-years.
Če vzamemo skupaj kontrolirane dele teh preskušanj in potekajoče in zaključene nadaljevalne študije z mediano trajanja približno 3,3 leta s 6.427 bolniki in prek 26.439 bolnikov-let zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov) približno 8,5 na 1.000 bolnikov-let.
Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Cyltezo.
Bolnike je zato treba pred, med in po zdravljenju z zdravilom Cyltezo natančno kontrolirati glede okužb, vključno s tuberkulozo.
Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Poročali so tudi o melanomu in karcinomu Merklovih celic pri bolnikih, zdravljenih z TNF-antagonisti, vključno z adalimumabom (glejte
Following 3 years of adalimumab therapy, 75 % (301/402) continued to be in clinical remission per partial Mayo score.
Po 3 letih zdravljenja z adalimumabom jih je 75 % (301/402) ostalo v klinični remisiji po
Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 19).
Ocena psoriaze nohtov je vključevala prilagojeni indeks izrazitosti psoriaze nohtov (mNAPSI, Modified Nail Psoriasis Severity Index), zdravnikovo globalno oceno psoriaze nohtov (PGA-F, Physician's Global Assessment of Fingernail Psoriasis) in indeks izrazitosti psoriaze nohtov (NAPSI, Nail Psoriasis Severity Index) (glejte preglednico 19).
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Cyltezo treatment.
Ženske v rodni dobi morajo premisliti o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še pet mesecev po zadnjem zdravljenju z zdravilom Cyltezo.
Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Čeprav ni statistično značilno, je bilo pri večini bolnikov dokazano klinično izboljšanje sekundarnih opazovanih dogodkov, kot so število mest entezitisa, število občutljivih sklepov, število oteklih sklepov, odziv glede na merila Pediatric ARC 50 in
The pivotal controlled studies involved 6,089 patients receiving adalimumab and 3,801 patients receiving placebo or active comparator during the controlled period.
Ključne kontrolirane študije, ki podpirajo vlogo za pridobitev dovoljenja za promet, so vključevale 6.089 bolnikov, ki so med kontroliranim obdobjem dobivali adalimumab, in 3.801 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
• sensation of heart beating irregularly such as skipped beats; • heart problems that can cause shortness of breath or ankle swelling;
• občutek neenakomernega bitja srca kot je preskakovanje utripov; • težave s srcem, ki lahko povzročijo kratko sapo ali otekanje gležnjev;
Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator.
Ko jo enkrat, namesto v hladilniku, shranjujete pri sobni temperaturi, morate injekcijsko brizgo porabiti v 14 dneh ali pa jo zavreči, tudi če jo vrnete v hladilnik.
Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50 % reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Zmanjšanje vnetnih lezij in preprečevanje poslabšanja abscesov in fistul z izcedkom so ocenili z rezultatom kliničnega odziva pri hidradenitis suppurativa (HiSCR, Hidradenitis Suppurativa Clinical Response); najmanj 50 % zmanjšanje skupnega števila abscesov in vnetnih nodulov brez povečanja števila abscesov in fistul z izcedkom glede na izhodiščno število.