natgillin/translations-raw huggingface dataset:
Tell your doctor immediately, or go to the casualty department at your nearest hospital.
Nemudoma se posvetujte z zdravnikom ali pojdite v ambulanto za nujno pomoč najbližje bolnišnice.
If you are self injecting, you should not use the outer area of the upper arms.
Če si zdravilo injicirate sami, ne uporabljajte injekcijskega mesta na zunanjem delu nadlakti.
All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g., persistent cough, wasting/weight loss, low-grade fever) appear during or after LIFMIOR treatment.
Vsem bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če se med zdravljenjem z zdravilom LIFMIOR ali po njem pojavijo znaki/simptomi, ki kažejo na tuberkulozo (npr. trdovraten kašelj, hiranje/hujšanje, nekoliko zvišana telesna temperatura).
The combination LIFMIOR and anakinra has not demonstrated increased clinical benefit, and is therefore not recommended.
Ni dokazano, da bi bila kombinacija zdravila LIFMIOR in anakinre klinično koristnejša, zato ni priporočljiva.
In plaque psoriasis, infiltration by inflammatory cells including T-cells leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Pri psoriazi v plakih se zaradi infiltracije vnetnih celic (vključno s celicami T) v psoriatičnih lezijah v primerjavi z neprizadeto kožo poveča koncentracija TNF.
These mean concentrations were similar to those seen in adult patients with plaque psoriasis treated with 25 mg etanercept twice weekly.
Te povprečne koncentracije so bile podobne koncentracijam, ki so jih opazili pri odraslih bolnikih s psoriazo v plakih, zdravljenih s 25 mg etanercepta dvakrat na teden.
Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Pri bolniku, ki se v tem obdobju ne odziva, je treba skrbno razmisliti o nadaljevanju zdravljenja.
Study 1 was a Phase 2 study in patients with active, but clinically stable, plaque psoriasis involving ≥ 10% of the body surface area who were ≥ 18 years old.
Študija 1 je bila študija 2. faze pri bolnikih, starih ≥ 18 let, z aktivno, a klinično stabilno psoriazo v plakih, ki je zajemala ≥ 10 % površine telesa.
Allergic reactions (see Skin and subcutaneous tissue disorders), autoantibody formation*
Bolezni imunskega sistema alergijske reakcije (glejte Bolezni kože in podkožja), nastanek avtoprotiteles*
Instructions for preparing and giving an injection of LIFMIOR
Navodila za pripravo in dajanje injekcije zdravila LIFMIOR
Study 4
Študija 4
UNIQUE IDENTIFIER-2D BARCODE 2D barcode carrying the unique identifier included.
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
• Once the solvent is added to the LIFMIOR, the plunger may move up by itself.
Ko je vehikel dodan zdravilu LIFMIOR, se lahko zgodi, da se bat brizge sam pomakne navzgor.
Based on current knowledge, a possible risk for the development of lymphomas, leukaemia or other haematopoietic or solid malignancies in patients treated with a TNF-antagonist cannot be excluded.
Na podlagi trenutnih dognanj pri bolnikih, ki se zdravijo z antagonistom TNF, morebitnega tveganja za razvoj limfomov, levkemije ali drugih hematopoetičnih ali čvrstih rakavih obolenj ni mogoče izključiti.
Mean (SE) Annualized Change from Baseline in Total Sharp Score Placebo
Povprečna (SE) sprememba skupne Sharpove ocene od izhodišča na leto Placebo
There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with LIFMIOR from post-marketing sources, including a very small number of cases indicating a positive rechallenge (see section 4.4).
Viri iz obdobja trženja so poročali o kronični vnetni črevesni bolezni in uveitisu pri bolnikih z JIA, ki so se zdravili z zdravilom LIFMIOR, vključno z zelo majhnim številom primerov, ki kažejo na ponoven pojav bolezni ob naslednjem dajanju zdravila (glejte poglavje 4.4).
The LIFMIOR solution should not be mixed with any other medicine before use.
Raztopine zdravila LIFMIOR pred uporabo ne smete mešati z drugimi zdravili.
Serious infections experienced by LIFMIOR-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Med resnimi okužbami pri bolnikih, zdravljenih z zdravilom LIFMIOR, so bile celulitis, gastroenteritis, pljučnica, holecistitis, osteomielitis, gastritis, apendicitis, streptokokni fasciitis, miozitis, septični šok, divertikulitis in absces.
Step 1: Setting up for an injection Step 2: Choosing an injection site Step 3: Injecting the LIFMIOR solution Step 4: Disposing of supplies
Korak 1: Priprava na injiciranje Korak 2: Izbira mesta injiciranja Korak 3: Injiciranje raztopine zdravila LIFMIOR Korak 4: Odstranjevanje odpadkov
LIFMIOR is administered by subcutaneous injection.
Zdravilo LIFMIOR se daje s subkutano injekcijo.
Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
Stevens-Johnsonov sindrom, kožni vaskulitis (vključno s preobčutljivostnim vaskulitisom), multiformni eritem, lihenoidne reakcije toksična epidermalna nekroliza
Chemical and physical in-use stability has been demonstrated for 6 hours at temperatures of up to 25°C after reconstitution.
Dokazali so, da je rekonstituirano zdravilo med uporabo kemijsko in fizikalno stabilno 6 ur pri temperaturi do 25 C.
• Severe psoriasis in patients from the age of 6 years who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
• za zdravljenje hude psoriaze pri bolnikih, starejših od 6 let, ki so se nezadostno odzvali na fototerapije ali druge sistemske terapije (ali jih niso prenašali).
In a polyarticular-course juvenile idiopathic arthritis trial with LIFMIOR, 69 patients (aged 4 to 17 years) were administered 0.4 mg LIFMIOR/kg twice weekly for three months.
V kliničnem preskušanju pri 69 bolnikih s poliartikularnim potekom juvenilnega idiopatskega artritisa, starih od 4 do 17 let, so injicirali 0,4 mg zdravila LIFMIOR/kg 2-krat tedensko v obdobju treh mesecev.
These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
Med temi so bili abscesi (na različnih mestih), bakteriemija, bronhitis, burzitis, celulitis, holecistitis, diareja, divertikulitis, endokarditis (sum nanj), gastroenteritis, hepatitis B, herpes zoster, razjeda na nogi, okužba ustne votline, osteomielitis, otitis, peritonitis, pljučnica, pielonefritis, sepsa, septični artritis, sinuzitis, okužbe kože, kožne razjede, okužbe sečil, vaskulitis in okužbe ran.
Methotrexate (n = 228)
metotreksat (n = 231)
• Signs of cancers: Cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer.
Rak lahko prizadene katerikoli del telesa, vključno s kožo in krvjo.
Adult patients with rheumatoid arthritis
Odrasli bolniki z revmatoidnim artritisom
At week 104, the mean change from baseline in the SPARCC score measured on MRI for all LIFMIOR-treated subjects was 4.64 for the SIJ (n=153) and 1.40 the spine (n=154).
Pri vseh bolnikih, ki so prejemali zdravilo LIFMIOR, je po 104 tednih povprečna sprememba od izhodišča za rezultat SPARCC, merjen z magnetnoresonančnim slikanjem, znašala 4,64 za SIJ (n = 153) in 1,40 za hrbtenico (n = 154).
24 vials of powder 24 pre-filled syringes of 1 ml solvent 24 stainless steel injection needles 24 vial adaptors
24 vial s praškom24 napolnjenih injekcijskih brizg z 1 ml vehikla 24 igel iz nerjavečega jekla 24 adapterjev za viale
• Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces (see Diagram 15).
S potegom naravnost proč od brizge odstranite pokrovček igle z injekcijske brizge in pri tem pazite, da se s prsti ne dotaknete igle in da se z iglo ne dotaknete ničesar (glejte sliko 15).
8 pre-filled syringes of 1 ml solvent 8 stainless steel injection needles 8 vial adaptors
8 napolnjenih injekcijskih brizg z 1 ml vehikla 8 igel iz nerjavečega jekla 8 adapterjev za viale
6 When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted.
Ko je brizga prazna, izvlecite iglo iz kože pod istim kotom, kot ste jo zabodli vanjo.
Pick up the pen, and remove the white needle cap by pulling it straight off (see Diagram 3).
Peresnik vzemite v roke in odstranite beli pokrovček igle, tako da ga potegnete naravnost proč (glejte sliko 3).
Before preparing the LIFMIOR solution, LIFMIOR may be stored outside of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again.
Pred pripravo raztopine zdravila LIFMIOR lahko zdravilo LIFMIOR shranjujete izven hladilnika pri temperaturi do največ 25 °C za enkratno obdobje do štirih tednov, po katerem se ga ne sme več ohladiti.
The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.
Neželeni učinki, o katerih so poročali najpogosteje, so: reakcije na mestu injiciranja (kot so bolečina, oteklina, srbenje, rdečina in krvavitev na mestu vboda), okužbe (kot so okužbe zgornjih dihal, bronhitis, okužbe sečnega mehurja in okužbe kože), alergijske reakcije, razvoj avtoprotiteles, srbenje in povišana telesna temperatura.
There have been postmarketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4).
V obdobju trženja so poročali o pancitopeniji in aplastični anemiji, nekateri od teh primerov so bili tudi smrtni (glejte poglavje 4.4).
Etanercept has been reported to be excreted in human milk following subcutaneous administration.
Etanercept se pri človeku po subkutani uporabi izloča v materino mleko.
Powder: Mannitol (E421), sucrose and trometamol Solvent: Water for injections
Pomožne snovi so: prašek: manitol (E421), saharoza in trometamol; vehikel: voda za injekcije.
At week 12, there was a statistically significant improvement in the SPARCC (Spondyloarthritis Research Consortium of Canada) score for the sacroiliac joint (SIJ) as measured by MRI for patients receiving LIFMIOR.
Pri bolnikih, ki so prejemali zdravilo LIFMIOR, je po 12 tednih prišlo do statistično pomembnega izboljšanja rezultata SPARCC (SPARCC - Spondyloarthritis Research Consortium of Canada; Kanadski konzorcij za raziskovanje spondilartritisa) za sakroiliakalni sklep (SIJ - Sacroiliac Joint), ki so ga merili z magnetnoresonančnim slikanjem.
However, your doctor may determine an alternative frequency at which to inject LIFMIOR.
Zdravnik vam lahko predpiše tudi drugačno pogostnost injiciranja zdravila LIFMIOR.
Uncommon ≥ 1/1,000 to < 1/100
Pogosti ≥ 1/100 do < 1/10
Instructions for preparing and giving an injection of LIFMIOR (See overleaf)
Navodila za pripravo in dajanje injekcije zdravila LIFMIOR (glejte drugo stran navodila)
There is generally no applicable use of LIFMIOR in children aged below 6 years in the indication plaque psoriasis.
Zdravila LIFMIOR se običajno ne uporablja za zdravljenje psoriaze v plakih pri otrocih, mlajših od 6 let.
Autoimmune hepatitis*
avtoimunski hepatitis*
Patients also had plaque psoriasis with a qualifying target lesion ≥ 2 cm in diameter.
Bolniki so imeli tudi psoriazo v plakih, pri čemer so za mejno velikost lezij šteli tiste z ≥ 2 cm premera.
• Infections/surgery: If the child develops a new infection, or is about to have any major surgery, the doctor may wish to monitor the child's treatment with LIFMIOR.
Okužbe/operacije: Če se pri otroku pojavi nova okužba ali če je pri otroku predvidena kakršnakoli večja operacija, bo zdravnik morda želel spremljati zdravljenje z zdravilom LIFMIOR.
Patients with paediatric plaque psoriasis (aged 4 to 17 years) were administered 0.8 mg/kg (up to a maximum dose of 50 mg per week) of etanercept once weekly for up to 48 weeks.
Bolniki z otroško psoriazo v plakih (stari od 4 do 17 let) so prejemali po 0,8 mg/kg (do največjega odmerka 50 mg na teden) etanercepta enkrat na teden do 48 tednov.
The 10 mg vial is for children prescribed a dose of 10 mg or less.
10 mg viala je namenjena za uporabo pri otrocih s predpisanim odmerkom 10 mg ali manj.
A higher rate of major birth defects was observed in one observational study comparing pregnancies exposed to etanercept (n=370) during the first trimester with pregnancies not exposed to etanercept or other TNF-antagonists (n=164) (adjusted odds ratio 2.4, 95% CI: 1.0-5.5).
V 1 opazovalni študiji, kjer so primerjali nosečnosti, izpostavljene etanerceptu (n = 370) v prvem trimesečju, z nosečnostmi, ki niso bile izpostavljene etanerceptu ali drugim antagonistom TNF (n = 164), so opazili večji delež resnih prirojenih napak (prilagojeno razmerje obetov 2,4, 95 % IZ: 1,0-5,5).
Some patients have developed a reaction at an injection site that was used before.
Pri nekaterih bolnikih se je reakcija pojavila na mestu predhodnega injiciranja.
• Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching.
• znaki vnetja krvnih žil, kot so bolečina, vročina, rdečina ali toplina kože ali srbenje.
Concurrent administration of LIFMIOR and anakinra has been associated with an increased risk of serious infections and neutropenia compared to LIFMIOR alone.
Sočasna uporaba zdravila LIFMIOR in anakinre je bila povezana s povečanim tveganjem za pojav resnih okužb in nevtropenije v primerjavi z zdravljenjem samo z zdravilom LIFMIOR.
• Then, slowly pull the plunger back to draw the liquid into the syringe (see Diagram 11).
Nato počasi potegnite bat nazaj, da izvlečete raztopino v brizgo (glejte sliko 11).
Your doctor may decide to continue to monitor the child for the presence of infections after the child stops using LIFMIOR.
Vaš zdravnik se bo morda odločil, da bo otroka tudi po koncu zdravljenja z zdravilom LIFMIOR spremljal glede prisotnosti okužb.
• Infections/diabetes: Tell your doctor if you or the child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
Okužbe/sladkorna bolezen: Povejte zdravniku, če imate vi ali otrok ponavljajoče se okužbe, sladkorno bolezen ali kakšno drugo stanje, pri katerem je tveganje za okužbo večje.
Treatment should be discontinued in patients who show no response after 12 weeks.
Pri bolnikih, ki po 12 tednih ne pokažejo odziva, je treba zdravljenje prekiniti.
48 alcohol swabs
48 alkoholnih blazinic
For psoriasis in patients from the age of 6 years, the usual dose is 0.8 mg of LIFMIOR per kg bodyweight (up to a maximum of 50 mg), and should be given once weekly.
Za psoriazo pri bolnikih od 6. leta starosti naprej je običajni odmerek 0,8 mg zdravila LIFMIOR na kg telesne mase (do največ 50 mg), dajati pa ga je treba enkrat na teden.
Neurological disorders
Nevrološke bolezni
• Infections/diabetes: Tell your doctor if the child has a history of recurrent infections, or suffers from diabetes or other conditions that increase the risk of infection.
Okužbe/sladkorna bolezen: Povejte zdravniku, če ima otrok ponavljajoče se okužbe, sladkorno bolezen ali kako drugo stanje, pri katerem je tveganje za okužbo večje.
• Nervous system and eye disorders: Tell your doctor if the child has multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord).
Bolezni živčevja in očesne bolezni: Povejte zdravniku, če ima otrok multiplo sklerozo, optični nevritis (vnetje očesnega živca) ali transverzni mielitis (vnetje hrbtnega mozga).
In part 1, all patients received 0.4 mg/kg (maximum 25 mg per dose) LIFMIOR subcutaneously twice weekly.
V prvem delu študije so vsi bolniki 2-krat tedensko prejemali po 0,4 mg/kg (največ 25 mg na odmerek) zdravila LIFMIOR subkutano.
Common ≥ 1/100 to
Pogosti ≥ 1/100 do
• While holding the needle and container in one hand, pick up the syringe and insert the syringe tip into the needle opening.
Medtem ko držite iglo z neodstranjenim delom embalaže v eni roki, z drugo roko primite brizgo ter vstavite konico brizge v odprtino igle.
• Nervous system and eye disorders: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord).
Bolezni živčevja in očesne bolezni: Povejte zdravniku, če imate vi ali otrok multiplo sklerozo, optični nevritis (vnetje očesnega živca) ali transverzni mielitis (vnetje hrbtnega mozga).
Adult patients with ankylosing spondylitis
Odrasli bolniki z ankilozirajočim spondilitisom
In an open-label, single-dose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
V odprti, enoodmerni, navzkrižni študiji pri zdravih prostovoljcih z dvema oblikama zdravljenja so ugotovili, da je enkratna injekcija 50 mg/ml etanercepta bioekvivalentna dvema sočasnima injekcijama 25 mg/ml.
Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal failure.
Pri bolnikih in zdravih prostovoljcih se po uporabi z radioaktivnim izotopom označenega etanercepta le-ta izloča z urinom, vendar pa pri bolnikih z akutno odpovedjo ledvic niso zaznali povečanih koncentracij etanercepta.
You can press a cotton ball or gauze over the injection site for 10 seconds.
Na mesto injiciranja lahko za 10 sekund pritisnete kos vate ali gazo.
Overall, infections were more commonly reported in patients treated with etanercept compared to methotrexate alone (3.8 versus 2%), and the infections associated with etanercept use were of a more severe nature.
Na splošno so pri bolnikih, ki so se zdravili z etanerceptom, pogosteje poročali o okužbah kot pri bolnikih, ki so se zdravili samo z metotreksatom (3,8 % v primerjavi z 2 %).
Rare ≥ 1/10,000 to
Redki ≥ 1/10.000 do
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, če je bil odziv na konvencionalno zdravljenje nezadosten.
Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome
Bolezni mišičnoskeletnega sistema in vezivnega tkiva kožni eritematozni lupus, subakutni kožni eritematozni lupus, lupusu podoben sindrom
In an open-label, safety extension study, 58 paediatric patients from the above study (from the age of 4 years at time of enrolment) continued to receive LIFMIOR for up to 10 years.
Varnost uporabe zdravila so spremljali v odprtem podaljšku študije, v katerem se je 58 otrok iz zgoraj omenjene študije (v času vključitve so bili stari 4 leta ali več) z zdravilom LIFMIOR zdravilo do 10 let.
LIFMIOR is supplied as a solution for injection in a pre-filled pen (MYCLIC) (solution for injection).
Zdravilo LIFMIOR je na voljo kot raztopina za injiciranje v napolnjenem injekcijskem peresniku (MYCLIC) (raztopina za injiciranje).
Patients in this study received a dose of 50 mg LIFMIOR or placebo once weekly for 12 weeks and then all patients received open-label 50 mg LIFMIOR once weekly for an additional 12 weeks.
Bolniki v tej študiji so dobivali odmerek 50 mg zdravila LIFMIOR ali placebo enkrat na teden 12 tednov, potem pa so vsi bolniki v odprtem delu dobivali 50 mg zdravila LIFMIOR enkrat na teden dodatnih 12 tednov.
Uveitis, scleritis
Očesne bolezni uveitis, skleritis
Various malignancies have also been reported with use of LIFMIOR, including cancers of the breast, lung, skin and lymph glands (lymphoma).
Pri uporabi zdravila LIFMIOR so poročali tudi o pojavu različnih malignih obolenj, vključno z rakom dojke, pljuč, kože in bezgavk (limfom).
Caution should be exercised in patients being treated with LIFMIOR who have a previous history of blood dyscrasias.
Previdnost je potrebna pri bolnikih, zdravljenih z zdravilom LIFMIOR, ki imajo krvno diskrazijo v anamnezi.
Push the plunger all the way into the syringe (see Diagram 10).
Bat brizge potisnite do konca v brizgo (glejte sliko 10).
Powder and solvent for solution for injection (powder for injection).
prašek in vehikel za raztopino za injiciranje (prašek za injekcijo)
• Anti-diabetic medicines: Tell your doctor if the child has diabetes or is taking medicines to treat diabetes.
Zdravila za zdravljenje sladkorne bolezni: Povejte zdravniku, če ima otrok sladkorno bolezen ali če jemlje zdravila za zdravljenje sladkorne bolezni.
If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.
Če vas skrbi izgled raztopine, se posvetujte s farmacevtom.
Do not attempt to recap the pen.
Na peresnik ne poskušajte znova namestiti pokrovčka.
• Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with LIFMIOR.
• Kronična vnetna črevesna bolezen (KVČB): Pri bolnikih z juvenilnim idiopatskim artritisom (JIA), ki so se zdravili z zdravilom LIFMIOR, so poročali o primerih KVČB.
The possibility exists for TNF-antagonists, including LIFMIOR, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Za antagoniste TNF, vključno z zdravilom LIFMIOR, velja, da lahko vplivajo na naravno odpornost bolnika proti okužbam in malignim obolenjem, saj TNF sodeluje pri vnetju in uravnava celični imunski odziv.
Axial spondyloarthritis
Aksialni spondilartritis
If these signs occur, tell your doctor immediately, or visit the casualty department at your nearest hospital.
Če se ti znaki pojavijo, se nemudoma posvetujte z zdravnikom ali pojdite v ambulanto za nujno pomoč najbližje bolnišnice.
Doses of 25 mg of LIFMIOR (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered SC twice a week for 6 months.
Odmerke zdravila LIFMIOR po 25 mg (na podlagi študij za ugotovitev odmerkov pri bolnikih z revmatoidnim artritisom) ali placebo so dajali subkutano dvakrat na teden 6 mesecev.
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) (see section 5.1).
Zdravljenje zmerne do hude psoriaze v plakih pri odraslih, ki se ne odzovejo na drugo sistemsko zdravljenje, vključno s ciklosporinom, metotreksatom ali psoralenom in ultravijolično svetlobo UV-A (PUVA), oziroma je pri njih le-to kontraindicirano ali ga ne prenašajo (glejte poglavje 5.1).
Histiocytosis haematophagic (macrophage activation
hematofagna histiocitoza (sindrom aktivacije makrofagov)
Other presentations of LIFMIOR are available in strengths of 10 mg, 25 mg and 50 mg.
Druge oblike zdravila LIFMIOR so na voljo v jakostih 10 mg, 25 mg in 50 mg.
• Hepatitis C: Tell your doctor if the child has hepatitis C. Your doctor may wish to monitor the treatment with LIFMIOR in case the infection worsens.
.• Hepatitis C: Povejte zdravniku, če ima vaš otrok hepatitis C. Zdravnik bo morda želel spremljati zdravljenje z zdravilom LIFMIOR za primer, če bi se okužba poslabšala.
There have been postmarketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking LIFMIOR.
Obstajajo poročila iz obdobja trženja o poslabšanju KSP pri bolnikih, ki jemljejo zdravilo LIFMIOR, ob prisotnosti dejavnikov, ki bi lahko sprožili tako poslabšanje, in brez njih.