natgillin/translations-raw huggingface dataset:
In study 4, the LIFMIOR-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p<0.0001).
V študiji 4 je bil v 12. tednu delež bolnikov z odzivom PASI 75 večji v skupini, zdravljeni z zdravilom LIFMIOR (38 %), kot v skupini, ki je dobivala placebo (2 %) (p < 0,0001).
LIFMIOR 25 mg is supplied as a white powder and solvent for solution for injection (powder for injection).
Zdravilo LIFMIOR 25 mg je na voljo v obliki belega praška in vehikla za raztopino za injiciranje (prašek za injekcijo).
Paediatric patients with juvenile idiopathic arthritis
Otroci z juvenilnim idiopatskim artritisom
4 MYCLIC pre-filled pens 4 alcohol swabs
4 napolnjeni injekcijski peresniki MYCLIC 4 alkoholne blazinice
CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including GuillainBarré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Bolezni živčevja demielinizirajoči pojavi v CŽS, ki kažejo na multiplo sklerozo, ali lokalizirana demielinizirajoča stanja, kot sta optični nevritis in transverzni mielitis (glejte poglavje 4.4), demielinizacija perifernega živčevja, vključno z GuillainBarréjevim sindromom, kronično vnetno demielinizirajočo polinevropatijo, demielinizirajočo polinevropatijo in multifokalno motorično nevropatijo (glejte poglavje 4.4), epileptični napad
Cartons contain 4 vials of LIFMIOR, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs.
Ena škatla vsebuje 4 viale zdravila LIFMIOR, 4 napolnjene injekcijske brizge z vodo za injekcije, 4 injekcijske igle, 4 adapterje za vialo in 8 alkoholnih blazinic.
In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving LIFMIOR during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy.
V eni študiji pri otrocih z juvenilnim idiopatskim artritisom, starih od 4 do 17 let, se je pri 43 od 69 otrok (62 %) med trimesečnim zdravljenjem z zdravilom LIFMIOR v času študije (prvi del, odprta) pojavila okužba.
Continued durable responses have been seen for up to 10 years in open-label extension treatment trials when patients received LIFMIOR without interruption.
Dolgotrajna odzivnost na neprekinjeno zdravljenje z zdravilom LIFMIOR je bila v odprtih podaljšanih kliničnih preskušanjih potrjena za obdobja do 10 let.
• Hepatitis B: Tell your doctor if the child has or has ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before the child begins treatment with LIFMIOR.
Hepatitis B: Povejte zdravniku, če ima ali je vaš otrok kdaj imel hepatitis B. Preden se bo vaš otrok začel zdraviti z zdravilom LIFMIOR, mora zdravnik opraviti test prisotnosti okužbe s hepatitisom B. Pri bolnikih, ki so kdaj že bili okuženi z virusom hepatitisa B, lahko zdravljenje z zdravilom LIFMIOR povzroči ponoven zagon hepatitisa B. V takem primeru morate zdravilo LIFMIOR prenehati uporabljati.
Radiographic Progression: Comparison of LIFMIOR vs Methotrexate vs LIFMIOR in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration (12 Month Results)
Radiografsko napredovanje: primerjava med zdravilom LIFMIOR, metotreksatom in kombinacijo zdravila LIFMIOR in metotreksata pri bolnikih z RA, ki je trajal 6 mesecev do 20 let (rezultati pri 12 mesecih)
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the LIFMIOR in combination with methotrexate group compared with the LIFMIOR alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p<0.05).
Odstotek bolnikov brez napredovanja (sprememba TSS ≤ 0,5) je bil po 24 mesecih večji v skupini, ki je dobivala zdravilo LIFMIOR v kombinaciji z metotreksatom, kakor v skupinah, ki sta dobivali zdravilo LIFMIOR ali metotreksat v monoterapiji (62 %, 50 % in 36 %, p < 0,05).
In part 2, patients with a clinical response at day 90 were randomised to remain on LIFMIOR or receive placebo for four months and assessed for disease flare.
V drugem delu študije pa so bolnike s kliničnim odzivom na zdravilo LIFMIOR na 90. dan randomizirali v dve podskupini: ena je nadaljevala zdravljenje z zdravilom LIFMIOR, druga pa je nadaljnje štiri mesece prejemala placebo - pri obeh so ocenjevali ponoven izbruh bolezni.
Autoimmune hepatitis
Avtoimunski hepatitis
A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. LIFMIOR was significantly better than placebo in all components of the ACR criteria as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Rezultati za zdravilo LIFMIOR so bili statistično pomembno boljši od placeba po vseh kriterijih ACR, prav tako pa tudi po tistih merilih aktivnosti revmatoidnega artritisa, ki v kriterije odziva po ACR niso vključeni, na primer jutranja okorelost.
LIFMIOR should be used with caution in patients with a history of hepatitis C.
Pri bolnikih z anamnezo hepatitisa C morate LIFMIOR uporabljati previdno.
Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)*
Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja (vključno s krvavitvijo, podplutbami, eritemom, srbenjem, bolečino in oteklino)*
No treatment was given for the majority of injection site reactions in the LIFMIOR treatment groups, and the majority of patients who were given treatment received topical preparations, such as corticosteroids, or oral antihistamines.
Večina bolnikov, pri katerih je zdravljenje le bilo potrebno, pa je prejela lokalna zdravila, npr. kortikosteroide, ali peroralne antihistaminike.
12 MYCLIC pre-filled pens 12 alcohol swabs
12 napolnjenih injekcijskih peresnikov MYCLIC 12 alkoholnih blazinic
Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes); inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon).
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): resne alergijske reakcije (vključno s hudim lokaliziranim otekanjem kože in piskajočim dihanjem); limfom (vrsta krvnega raka); levkemija (rak, ki prizadene kri in kostni mozeg); melanom (vrsta kožnega raka); kombinacija znižanja števila trombocitov in rdečih ter belih krvnih celic; motnje živčevja (s hudo mišično oslabelostjo ter z znaki in simptomi, podobnimi multipli sklerozi ali vnetje očesnih živcev ali hrbtenjače); tuberkuloza; nastanek kongestivnega srčnega popuščanja; epileptični napadi; lupus ali lupusu podoben sindrom (med simptomi so lahko trdovraten izpuščaj, vročina, bolečine v sklepih in utrujenost); kožni izpuščaj, ki lahko povzroči močno mehurjenje in luščenje kože; lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah); vnetje jeter, ki je posledica delovanja imunskega sistema proti tkivu lastnega telesa (avtoimunski hepatitis; pri bolnikih, ki sočasno prejemajo metotreksat, je občasen); imunska bolezen, ki lahko prizadene pljuča, kožo in bezgavke (sarkoidoza); vnetje ali brazgotinjenje pljuč (pri bolnikih, ki sočasno prejemajo metotreksat, je vnetje ali brazgotinjenje pljuč občasno).
Among patients with ankylosing spondylitis who received LIFMIOR, the clinical responses were apparent at the time of the first visit (2 weeks) and were maintained through 6 months of therapy.
Med bolniki z ankilozirajočim spondilitisom, ki so prejemali zdravilo LIFMIOR, so bili klinični odzivi vidni že pri prvem obisku (po 2 tednih) in so se ohranjali ves čas 6 mesecev zdravljenja.
A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 LIFMIOR-treated psoriatic arthritis patients.
V kliničnih študijah z zdravilom LIFMIOR, ki so trajale približno 2 leti in so vključevale 240 bolnikov s psoriatičnim artritisom, so poročali o 2 primerih malignega obolenja.
Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common).
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): resne okužbe (vključno s pljučnico, globokimi okužbami kože, okužbami sklepov, okužbo krvi in okužbami na različnih mestih); poslabšanje kongestivnega srčnega popuščanja; nizko število rdečih krvnih celic, nizko število belih krvnih celic, nizko število nevtrofilcev (vrste belih krvnih celic); nizko število krvnih ploščic; kožni rak (razen melanoma); lokalizirano otekanje kože (angioedem); koprivnica (rdeče ali blede kožne spremembe nad ravnijo kože, ki pogosto srbijo); očesno vnetje; luskavica (na novo nastala ali poslabšanje obstoječe); vnetje krvnih žil, ki negativno vpliva na več organov; zvečane vrednosti jetrnih encimov pri krvnih preiskavah (pri bolnikih, ki sočasno prejemajo metotreksat, so zvečane vrednosti jetrnih encimov pri krvnih preiskavah pogoste).
If you or the child in your care have Wegener's granulomatosis, talk to your doctor.
Povejte zdravniku, če imate vi ali otrok, za katerega skrbite, Wegenerjevo granulomatozo.
If the doctor has not given this instruction, please contact him/her.
Posvetujte se z zdravnikom, če od njega takih navodil niste dobili.
LIFMIOR to patients with pre-existing or recent onset of demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease.
Pri bolnikih z demielinizirajočimi obolenji, ki so obstajala že prej ali so nastopila pred kratkim, ali pri tistih, ki imajo povečano tveganje za razvoj demielinizirajoče bolezni, je treba pred zdravljenjem z zdravilom LIFMIOR skrbno pretehtati tveganja in koristi, vključno z nevrološko oceno.
• The doctor or his/her assistant should have instructed you on the proper amount of solution to be withdrawn from the vial.
dravnik ali medicinska sestra vam morata natančno pojasniti koliko raztopine morate izvleči iz viale.
Patients received LIFMIOR 0.8 mg/kg (up to 50 mg) or placebo once weekly for 12 weeks.
Bolniki so 12 tednov enkrat na teden prejemali zdravilo LIFMIOR v odmerku 0,8 mg/kg (do 50 mg) ali placebo.
LIFMIORa
zdravilo LIFMIOR
CARTON TEXT (For paediatric use) - EU/1/16/1165/001
BESEDILO NA ŠKATLI - (za uporabo pri otrocih) - EU/1/16/1165/001
Among patients with plaque psoriasis who received LIFMIOR, significant responses relative to placebo were apparent at the time of the first visit (2 weeks) and were maintained through 24 weeks of therapy.
Med bolniki s psoriazo v plakih, ki so dobivali zdravilo LIFMIOR, je bil pomemben odziv v primerjavi s placebom opazen na prvem pregledu (po 2 tednih) in se je ohranil skozi 24 tednov zdravljenja.
Paediatric patients with plaque psoriasis
Pediatrični bolniki s psoriazo v plakih
Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Zdravljenje artritisa, povezanega z entezitisom, pri mladostnikih, starih 12 let ali več, ki so se nezadostno odzvali na konvencionalno zdravljenje ali ga niso prenašali.
Serious and fatal infections have been reported during use of LIFMIOR; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi.
Med povzročitelji, o katerih so poročali, so bile bakterije, mikobakterije (vključno s tuberkulozo), virusi in glivice.
For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Če je bolnik pozitiven na HBV, je pred uvedbo zdravljenja z zdravilom LIFMIOR priporočljivo posvetovanje z zdravnikom specialistom za zdravljenje hepatitisa B. Pri dajanju zdravila LIFMIOR bolnikom, ki so že bili okuženi s HBV, je potrebna previdnost.
Using the MYCLIC pre-filled pen to inject LIFMIOR
Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila LIFMIOR
OTHER MYCLIC Pre-filled pen
Napolnjeni peresnik MYCLIC
• Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using LIFMIOR.
Norice: Povejte zdravniku, če ste bili vi ali otrok med zdravljenjem z zdravilom LIFMIOR izpostavljeni noricam.
At week 12, more patients randomised to LIFMIOR had positive efficacy responses (e.g., PASI 75) than those randomised to placebo.
V 12. tednu je imelo pozitivne odzive glede učinkovitosti (npr. PASI 75) več bolnikov v skupini z zdravilom LIFMIOR kot v skupini s placebom.
Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including LIFMIOR.
Pri bolnikih, zdravljenih z antagonisti TNF, vključno z zdravilom LIFMIOR, so poročali o melanomu in nemelanomskem kožnem raku (NMSC- Non-Melanoma Skin Cancer).
Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist.
Uporabljeno iglo in brizgo odstranjujte v skladu z navodili zdravnika, medicinske sestre ali farmacevta.
No clinically significant pharmacokinetic drug-drug interactions were observed in studies with methotrexate, digoxin or warfarin.
V študijah z metotreksatom, digoksinom ali varfarinom klinično pomembnih farmakokinetičnih interakcij med zdravili niso opazili.
Nervous system disorders
Bolezni živčevja demielinizirajoči pojavi
Dispose of the needles and syringe as instructed by your doctor, nurse or pharmacist.
Uporabljeno iglo in brizgi odstranjujte v skladu z navodili zdravnika, medicinske sestre ali farmacevta.
LIFMIOR should not be used if all the powder in the vial is not dissolved within 10 minutes.
Zdravila LIFMIOR ne smete uporabiti, če se ves prašek v viali ne raztopi v 10 minutah; v tem primeru to vialo zavrzite in vzemite novo.
Each vial contains 10 mg of etanercept.
Ena viala vsebuje 10 mg etanercepta.
The LIFMIOR pre-filled pen is available in a 50 mg strength.
Napolnjeni injekcijski peresnik LIFMIOR je na voljo v jakosti 50 mg.
A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. LIFMIOR was significantly better than placebo in all components of the
Odziv na 10 mg odmerek je bil po vrednosti med odzivoma na placebom in 25 mg odmerek.
If you have any questions about storage, contact your doctor, nurse, or pharmacist for further instructions.
Če imate glede shranjevanja kakršnokoli vprašanje, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
Do not shake the pre-filled syringe of LIFMIOR.
Napolnjenih injekcijskih brizg zdravila LIFMIOR ne smete tresti.
The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of LIFMIOR in adult patients with rheumatoid arthritis, and the majority were mild.
Neželeni učinki pri bolnikih z juvenilnim idiopatskim artritisom so bili po vrstah in deležih podobni tistim, opisanim v preskušanjih zdravila LIFMIOR pri odraslih bolnikih z revmatoidnim artritisom.
In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0.54% (frequency uncommon).
V dvojno slepih obdobjih nadzorovanih kliničnih preskušanj etanercepta za vse indikacije je bila pogostnost (delež pojavnosti) neželenih učinkov zvečanih vrednosti jetrnih encimov pri bolnikih, ki so prejemali etanercept brez sočasnega metotreksata, 0,54 % (pogostnost: občasni).
25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept.
25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta.
LIFMIOR was administered at doses of 25 mg once a week, 25 mg twice a week or 50 mg twice a week for 6 consecutive months.
Zdravilo LIFMIOR so dobivali 6 mesecev zapored v odmerkih 25 mg enkrat na teden, 25 mg dvakrat na teden ali 50 mg dvakrat na teden.
In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of autoimmune hepatitis was 0.24% (frequency uncommon).
V nadzorovanih kliničnih preskušanjih, v katerih je bilo dovoljeno sočasno zdravljenje z etanerceptom in metotreksatom, je bila pogostnost (delež pojavnosti) avtoimunskega hepatitisa 0,24 % (pogostnost: občasni).
Solution for injection in pre-filled syringe
raztopina za injiciranje v napolnjeni injekcijski brizgi
Dispose of the used pen as instructed by your doctor, nurse or pharmacist.
Rabljeni peresnik odstranjujte v skladu z navodili zdravnika, medicinske sestre ali farmacevta.
Increased etanercept concentrations were not observed in patients with acute hepatic failure.
Pri bolnikih z akutno odpovedjo jeter niso opazili povečanih koncentracij etanercepta.
50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept.
50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 50 mg etanercepta.
Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling).
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): okužbe (vključno s prehladi, sinuzitisom, bronhitisom, okužbami sečil in okužbami kože); reakcije na mestu injiciranja (vključno s krvavitvami, podplutbami, rdečino, srbenjem, bolečino in oteklino).
2 MYCLIC pre-filled pens 2 alcohol swabs
2 napolnjena injekcijska peresnika MYCLIC 2 alkoholni blazinici
Refer to package leaflet for alternative storage details.
Za podrobnosti o pogojih shranjevanja glejte navodilo za uporabo.
4 pre-filled syringes 4 alcohol swabs
4 napolnjene injekcijske brizge 4 alkoholne blazinice
Thrombocytopenia, anaemia, leukopenia, neutropenia
Bolezni krvi in limfatičnega sistema trombocitopenija, anemija, levkopenija, nevtropenija pancitopenija*
Treatment with LIFMIOR may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
B, lahko zdravljenje z zdravilom LIFMIOR povzroči ponoven zagon hepatitisa B. V takem primeru morate zdravilo LIFMIOR prenehati uporabljati.
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
Pridobljen je z rekombinantno DNK tehnologijo v sesalskem ekspresijskem sistemu, in sicer v ovarijskih celicah kitajskega hrčka (CHO - Chinese Hamster Ovary).
In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of interstitial lung disease was 0.47% (frequency uncommon).
V nadzorovanih kliničnih preskušanjih, v katerih je bilo dovoljeno sočasno zdravljenje z etanerceptom in metotreksatom, je bila pogostnost (delež pojavnosti) intersticijske bolezni pljuč 0,47 % (pogostnost: občasni).
In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of interstitial lung disease in patients receiving etanercept without concomitant methotrexate was 0.06% (frequency rare).
V nadzorovanih kliničnih preskušanjih etanercepta za vse indikacije je bila pogostnost (delež pojavnosti) intersticijske bolezni pljuč pri bolnikih, ki so prejemali etanercept brez sočasnega metotreksata, 0,06 % (pogostnost: redki).
n = 196 wk 12
teden n = 196
The following instructions explain how to prepare and inject LIFMIOR.
V tem navodilu sta opisana priprava in dajanje injekcij zdravila LIFMIOR.
Then continue to inject the medicine on the usual day(s).
V tem primeru pozabljeni odmerek preskočite, nato pa nadaljujte z injiciranjem zdravila na predvideni dan (dneve).
Each vial of LIFMIOR 10 mg should be used on a single occasion in a single patient, and the remainder of the vial should be discarded.
Ena viala z zdravilom LIFMIOR 10 mg je namenjena za enkratno uporabo pri enem bolniku.
Each vial contains 25 mg of etanercept.
Ena viala vsebuje 25 mg etanercepta.
Cartons contain 4, 8 or 24 vials of LIFMIOR with 4, 8 or 24 pre-filled solvent syringes, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs.
Ena škatla vsebuje 4, 8 ali 24 vial zdravila LIFMIOR, 4, 8 ali 24 z vehiklom napolnjenih injekcijskih brizg, 4, 8 ali 24 igel, 4, 8 ali 24 adapterjev za viale in 8, 16 ali 48 alkoholnih blazinic.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for LIFMIOR
IME ZDRAVILA IN POT(I) UPORABE
Purple needle safety shield
Beli pokrovček igle vijolični varnostni ščit igle
Each pre-filled syringe contains 0.5 ml of solution, providing 25 mg of etanercept.
Ena napolnjena injekcijska brizga vsebuje 0,5 ml raztopine, ki vsebuje 25 mg etanercepta.
If the child in your care has Wegener's granulomatosis, talk to your doctor.
Povejte zdravniku, če ima otrok, za katerega skrbite, Wegenerjevo granulomatozo.
Each vial should be used for just one dose in one patient, and any remaining solution should be discarded.
Ena viala je namenjena samo za aplikacijo enega odmerka enemu bolniku.
• If the child has psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“psoriasis skin lesions”).
Če ima otrok luskavico, se morate izogibati neposrednemu injiciranju v vsa privzdignjena, zadebeljena, rdeča ali luskava območja na koži ('psoriatične kožne spremembe').
Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly.
Če je treba, je zdravilo mogoče uporabljati tudi v odmerku 50 mg dvakrat na teden do 12 tednov, čemur sledi odmerek 25 mg dvakrat na teden ali 50 mg enkrat na teden.
1 LIFMIOR vial
Vehikel za LIFMIOR subkutana uporaba
Adult patients had serum samples tested for autoantibodies at multiple timepoints.
Med zdravljenjem so odraslim bolnikom večkrat odvzeli vzorec seruma in ga pregledali na pojav avtoprotiteles.
Adult patients with plaque psoriasis
Odrasli bolniki s psoriazo v plakih
• Keep this leaflet.
• S podstavka vzemite vso vsebino.
Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
Zdravnik vam lahko predpiše tudi 50 mg dvakrat na teden za največ 12 tednov, čemur sledi odmerek 25 mg dvakrat na teden ali 50 mg enkrat na teden.