natgillin/translations-raw huggingface dataset:
Patients should be instructed to seek medical advice if signs/ symptoms (e. g., persistent cough, wasting/ weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after therapy with Humira.
Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem s Humiro ali po njem doživijo znake ali simptome (npr. trdovraten kašelj, hujšanje/ izgubljanje teže, nekoliko zvišano telesno temperaturo), ki nakazujejo tuberkulozno okužbo.
Opportunistic infections, including invasive fungal infections have been observed in patients receiving Humira.
Pri bolnikih, ki so dobivali Humiro, so opažali oportunistične okužbe, vključno z invazivnimi glivičnimi okužbami.
These infections have not consistently been recognised in patients taking TNF-blockers and this resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Takšne okužbe se pri uporabnikih zaviralcev TNF niso pojavljale vedno, zato je v primerih njihovega nastanka prihajalo do zamud pri ustreznem zdravljenju, kar je včasih povzročilo smrt.
For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnea, and/ or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasivie fungal infection should be suspected and administration of Humira should be promptly discontinued and appropriate antifungal therapy should be initiated.
V takšnem primeru je treba uporabo Humire nemudoma prekiniti in uvesti ustrezno antimikotično zdravljenje.
Reactivation of hepatitis B has occurred in patients who are chronic carriers of this virus when receiving a TNF-antagonist including Humira.
Pri bolnikih, ki so bili kronični nosilci virusa hepatitisa B, ko so dobivali antagonist TNF (vključno s Humiro), so opažali reaktivacijo hepatitisa B.
Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating Humira therapy.
Bolnike, ki jih ogroža okužba s HBV, je treba pred začetkom zdravljenja s Humiro oceniti glede znakov okužbe s HBV v preteklosti.
Carriers of HBV who require treatment with Humira should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Nosilce HBV, ki potrebujejo zdravljenje s Humiro, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okužbe s HBV.
Adequate data from the treatment of patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
In patients who develop HBV reactivation, Humira should be stopped and effective anti- viral therapy with appropriate supportive treatment should be initiated.
Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo Humire prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
TNF-antagonists including Humira have been associated in rare instances with new onset or exacerbation of clinical symptoms and/ or radiographic evidence of demyelinating disease including multiple sclerosis.
Antagonisti tumorje nekrotizirajočega faktorja (TNF), s Humiro vred, so bili v redkih primerih povezani s pojavom ali poslabšanjem kliničnih simptomov in/ ali rentgenoloških znakov demielinizirajoče bolezni, vključno z multiplo sklerozo.
Prescribers should exercise caution in considering the use of Humira in patients with pre-existing or recent-onset central nervous system demyelinating disorders.
Pri odločanju za uporabo Humire pri bolnikih z že prej obstoječimi ali nedavno nastalimi demielinizirajočimi boleznimi osrednjega živčevja je potrebna previdnost.
6 Allergic reactions
Alergijske reakcije
Serious allergic adverse reactions have not been reported with subcutaneous administration of Humira during clinical trials.
V kliničnih študijah med subkutano uporabo Humire ni bilo opisanih resnih alergijskih neželenih reakcij.
Non-serious allergic reactions associated with Humira were uncommon during clinical trials.
S Humiro povezane alergijske reakcije, ki niso bile resne, so se v kliničnih študijah pojavljale občasno.
In postmarketing, serious allergic reactions including anaphylaxis have been reported very rarely following Humira administration.
V pomarketinškem obdobju so po uporabi Humire v zelo redkih primerih poročali o resnih alergijskih reakcijah, vključno z anafilaksijo.
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Humira should be discontinued immediately and appropriate therapy initiated.
Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo Humire nemudoma prekiniti in uvesti ustrezno zdravljenje.
The needle cover of the syringe contains natural rubber (latex).
6 Pokrovček igle na brizgi vsebuje naravno gumo (lateks).
In a study of 64 patients with rheumatoid arthritis that were treated with Humira, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B, - NK-cells, monocyte/ macrophages, and neutrophils.
V študiji 64 bolnikov z revmatoidnim artritisom, zdravljenih s Humiro, niso odkrili znakov zavrtja odložene preobčutljivosti, znižanja koncentracije imunoglobulinov ali spremembe števila efektorskih celic T in B, naravnih celic ubijalk, monocitov/ makrofagov ali nevtrofilcev.
With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
S sedanjim znanjem možnega tveganja za razvoj limfomov ali drugih malignomov pri bolnikih, zdravljenih z antagonistom TNF, ni mogoče izključiti.
Rare postmarketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab.
Pri bolnikih, zdravljenih z adalimumabom, je bil v redkih postmarketinških primerih identificiran hepatosplenični limfom celic T.
Some of these hepatosplenic T-cell lymphomas with Humira have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for Crohn’ s disease.
Pri uporabi Humire so se nekateri od hepatospleničnih limfomov celic T pojavili pri mladih odraslih bolnikih, ki so se sočasno zdravili z azatioprinom ali 6- merkaptopurinom, ki se uporabljata pri Crohnovi bolezni.
A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Humira cannot be excluded (see section 4.8).
Tveganja za razvoj hepatospleničnega limfoma celic T pri bolnikih, ki dobivajo Humiro, ni mogoče izključiti (glejte poglavje 4. 8).
No studies have been conducted that include patients with a history of malignancy or in whom treatment with Humira is continued following development of malignancy.
Študij, ki bi vključevale bolnike z anamnezo malignoma ali bolnike, pri katerih bi se zdravljenje s Humiro nadaljevalo po pojavu malignoma, ni bilo.
Thus additional caution should be exercised in considering Humira treatment of these patients (see section 4.8).
Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju s Humiro pri teh bolnikih (glejte poglavje 4. 8).
All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of non- melanoma skin cancer prior to and during treatment with Humira.
Pred zdravljenjem s Humiro in med zdravljenjem z njo je treba za nemelanomskega kožnega raka pregledati vse bolnike, še zlasti pa bolnike z anamnezo intenzivne imunosupresivne terapije in bolnike s psoriazo, ki so kdaj prejemali PUVA.
Rare reports of pancytopenia including aplastic anaemia have been reported with TNF antagonists.
Pri uporabi antagonistov TNF je bila v redkih primerih opisana pancitopenija, vključno z aplastično anemijo.
Adverse events of the haematologic system, including medically significant cytopoenia (e. g. thrombocytopaenia, leucopaenia) have been infrequently reported with Humira.
Med uporabo Humire so redko poročali o neželenih učinkih na hematološki sistem, vključno z medicinsko pomembno citopenijo (npr. trombocitopenijo, levkopenijo).
Discontinuation of
Vsem bolnikom je treba naročiti, naj nemudoma poiščejo zdravniško pomoč, če se jim med uporabo Humire pojavijo znaki ali simptomi krvnih diskrazij (npr. trajno zvišana telesna temperatura, podplutbe, krvavitve, bledica).
7 Humira therapy should be considered in patients with confirmed significant haematologic abnormalities.
Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije s Humiro.
Vaccinations Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
V študiji 226 odraslih preiskovancev z revmatoidnim artritisom, ki so dobivali adalimumab ali placebo, so ugotovili podobne odzive protiteles na standardno 23- valentno pnevmokokno cepivo in trivalentno virusno cepivo proti influenci.
No data are available on the secondary transmission of infection by live vaccines in patients receiving Humira.
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, zdravljenih s Humiro, ni.
It is recommended that polyarticular juvenile idiopathic arthritis patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy.
7 Za bolnike s poliartikularnim juvenilnim idiopatskim artritisom je priporočljivo, da pred začetkom zdravljenja s Humiro opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
Patients on Humira may receive concurrent vaccinations, except for live vaccines.
Bolniki, ki prejemajo Humiro, lahko sočasno dobijo cepiva, razen živih cepiv.
Cases of worsening congestive heart failure have also been reported in patients receiving Humira.
O primerih poslabšanja kongestivnega srčnega popuščanja so poročali tudi pri bolnikih, ki so prejemali Humiro.
Humira should be used with caution in patients with mild heart failure (NYHA class I/ II).
Pri bolnikih z blagim srčnim popuščanjem (razred I/ II po NYHA) je treba Humiro uporabljati previdno.
Humira is contraindicated in moderate to severe heart failure (see section 4.3).
Pri bolnikih z zmernim do hudim srčnim popuščanjem je Humira kontraindicirana (glejte poglavje 4. 3).
Treatment with Humira must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Pri bolnikih, ki se jim na novo pojavijo simptomi kongestivnega srčnega popuščanja ali se jim takšni simptomi poslabšajo, je treba zdravljenje s Humiro prekiniti.
Treatment with Humira may result in the formation of autoimmune antibodies.
Zdravljenje s Humiro lahko povzroči nastanek avtoimunskih protiteles.
The impact of long- term treatment with Humira on the development of autoimmune diseases is unknown.
Vpliv dolgoročnega zdravljenja s Humiro na nastanek avtoimunskih bolezni ni znan.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Humira and is positive for antibodies against double-stranded DNA, further treatment with Humira should not be given (see section 4.8).
Če se bolniku po zdravljenju s Humiro pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja s Humiro ne sme nadaljevati (glejte poglavje 4. 8).
(See section 4.5).
Zato kombinacija adalimumaba in anakinre ni priporočena (glejte poglavje 4. 5).
Concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
Sočasna uporaba antagonistov TNF in abatacepta je povezana s povečanim tveganjem za okužbe, vključno z resnimi okužbami, brez večje klinične prednosti, v primerjavi z uporabo samih antagonistov TNF.
(See Section 4.5).
Kombinacija Humire in abatacepta ni priporočljiva (glejte poglavje 4. 5).
There is limited safety experience of surgical procedures in patients treated with Humira.
Izkušnje z varnostjo operacij pri bolnikih, zdravljenih s Humiro, so omejene.
A patient who requires surgery while on Humira should be closely monitored for infections, and appropriate actions should be taken.
Bolnika, ki med zdravljenjem s Humiro potrebuje operacijo, je treba natančno nadzirati glede okužb in ustrezno ukrepati.
There is limited safety experience in patients undergoing arthroplasty while receiving Humira.
Izkušnje z varnostjo pri bolnikih, ki so jim med zdravljenjem s Humiro opravili artroplastiko, so omejene.
8 Small bowel obstruction
Zapora tankega črevesa
Failure to respond to treatment for Crohn’ s disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment.
Če se bolnik ne odzove na zdravljenje Crohnove bolezni, lahko to pomeni, da ima stalno fibrotično strikturo, zaradi katere utegne biti potrebno kirurško zdravljenje.
Available data suggest that Humira does not worsen or cause strictures.
Razpoložljivi podatki kažejo, da Humira ne poslabša in ne povzroči striktur.
Humira has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking Humira as monotherapy and those taking concomitant methotrexate.
Humiro so raziskali pri bolnikih z revmatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom in psoriatičnim artritisom, ki so Humiro jemali v monoterapiji, kot pri tistih, ki so jo jemali hkrati z metotreksatom.
Antibody formation was lower when Humira was given together with methotrexate in comparison with use as monotherapy.
Če je bila Humira uporabljena skupaj z metotreksatom, je bilo nastajanje
Administration of Humira without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
Uporaba Humire brez metotreksata je zvečala nastajanje protiteles, zvečala očistek in zmanjšala učinkovitost adalimumaba (glejte poglavje 5. 1).
The combination of Humira and anakinra is not recommended (see section 4.4 “ Concurrent administration of TNF-antagonists and anakinra”).
Kombinacija Humire in anakinre ni priporočljiva (glejte poglavje 4. 4 “ Sočasna uporaba antagonistov TNF in anakinre ”).
The combination of Humira and abatacept is not recommended (see section 4.4 “ Concurrent administration of TNF-antagonists and abatacept”).
Kombinacija Humire in abatacepta ni priporočljiva (glejte poglavje 4. 4 “ Sočasna uporaba antagonistov TNF in abatacepta ”).
For Humira, no clinical data on exposed pregnancies are available
Za Humiro ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
Preclinical data on postnatal toxicity and fertility effects of adalimumab are not available (see section 5.3).
Predkliničnih podatkov o poporodni toksičnosti adalimumaba in njegovih učinkih na plodnost ni (glejte poglavje 5. 3).
Women of childbearing potential are strongly recommended to use adequate contraception to prevent pregnancy and continue its use for at least five months after the last Humira treatment.
Ženske v rodni dobi morajo za preprečitev nosečnosti uporabljati ustrezno kontracepcijsko zaščito in z njo nadaljevati vsaj še pet mesecev po zadnjem zdravljenju s Humiro.
However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last Humira treatment.
Ker se človeški imunoglobulini izločajo v mleku, ženske ne smejo dojiti vsaj pet mesecev po zadnjem zdravljenju s Humiro.
Humira may have a minor influence on the ability to drive and use machines.
Humira ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Humira (see Section 4.8)
Po dajanju Humire se lahko pojavi omotica (vključno z vrtoglavico, motnjami vida in utrujenostjo) (glejte poglavje 4. 8).
Humira was studied in 6593 patients in controlled and open label trials for up to 60 months.
Humiro so raziskali pri 6593 bolnikih v kontroliranih in odprtih preskušanjih, ki so trajala do 60 mesecev.
These trials included rheumatoid arthritis patients with short term and long standing disease, polyarticular juvenile idiopathic arthritis as well as psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease and psoriasis patients.
Ta preskušanja so vključila bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), poliartikularnim juvenilnim idiopatskim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom, Crohnovo boleznijo in psoriazo.
The data in Table 1 is based on the pivotal controlled Studies involving 4,355 patients receiving Humira and 2,487 patients receiving placebo or active comparator during the controlled period.
Podatki v tabeli 1 temeljijo na kontroliranih ključnih kliničnih študijah, ki zajemajo 4355 bolnikov, ki so med kontroliranim obdobjem dobivali Humiro, in 2487 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
9 The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 4.5% for patients taking Humira and 4.5% for control treated patients.
Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje med dvojno slepim, kontroliranim delom ključnih študij, je bil 4, 5% v skupini, ki je prejemala Humiro, in 4, 5% v kontrolni skupini.
Undesirable effects in paediatric patients with polyarticular juvenile idiopathic arthritis
Neželeni učinki pri pediatričnih bolnikih s poliartikularnim juvenilnim idiopatskim artritisom
Adverse events at least possibly causally-related to adalimumab for pivotal studies, both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/ 10; common ≥ 1/ 100 to < 1/ 10; uncommon ≥ 1/ 1,000 to < 1/ 100 and rare ≥ 1/ 10,000 to < 1/ 1,000) in Table 1 below.
Klinični in laboratorijski neželeni učinki, ki so vsaj potencialno vzročno povezani z adalimumabom v ključnih študijah, so navedeni po organskih sistemih in pogostnosti: zelo pogosti (≥1/ 10), pogosti (≥1/ 100 do < 1/ 10), občasni (≥1/ 1. 000 do < 1/ 100) in redki (≥1/ 10. 000 do < 1/ 1. 000) v tabeli 1 spodaj.
Table 1 Undesirable Effects in Clinical Studies
9 Tabela 1 Neželeni učinki v kliničnih študijah
System Organ Class Investigations
Organski sistem Preiskave
Frequency Uncommon
Pogostnost občasni
Adverse Reaction blood creatine phosphokinase increased, activated partial thromboplastin time prolonged, autoantibodies present
Neželeni učinki zvišanje kreatin fosfokinaze v krvi, podaljšan aktivirani parcialni tromboplastinski čas, prisotna avtoprotitelesa
arrhythmias, tachycardia
aritmije, tahikardija
cardiac arrest, coronary artery insufficiency, angina pectoris, pericardial effusion, congestive cardiac failure, palpitations
zastoj srca, insuficienca koronarnih arterij, angina pektoris, perikardialna efuzija, kongestivno srčno popuščanje, palpitacije
neutropaenia (including agranulocytosis), leucopaenia, thrombocytopaenia, anaemia, lymphadenopathy, leucocytosis, lymphopaenia
nevtropenija (vključno z agranulocitozo), levkopenija, trombocitopenija, anemija, limfadenopatija, levkocitoza, limfopenija
pancytopaenia, idiopathic thrombocytopaenic purpura
pancitopenija, idiopatska trombocitopenična purpura
syncope, migraine, tremor, sleep disturbances
sinkopa, migrena, tremor, motnje spanja
multiple sclerosis, facial palsy
multipla skleroza, facialna palzija
vision disorder, ocular sensation disorders, infection, irritation or inflammation of the eye
bolezni vida, motnje vidnega zaznavanja, okužba, draženje ali vnetje očesa
panophthalmitis, iritis, glaucoma
panoftalmitis, iritis, glavkom
10 System Organ Class Ear and labyrinth disorders
Ušesne bolezni, vključno z motnjami labirinta
Frequency Uncommon
občasni
Adverse Reaction ear discomfort (including pain and swelling)
neprijetno občutenje v ušesu (vključno z bolečino in otekanjem)
hearing loss, tinnitus
izguba sluha, tinitus
rectal haemorrhage, vomiting, dyspepsia, abdominal bloating, constipation
rektalna krvavitev, bruhanje, dispepsija, napenjanje v trebuhu, zaprtje
pancreatitis, intestinal stenosis, colitis, enteritis, oesophagitis, gastritis
pankreatitis, intestinalna stenoza, kolitis, enteritis, ezofagitis, gastritis
Renal and urinary disorders
10 Organski sistem Bolezni sečil
Uncommon
Pogostnost občasni
haematuria, renal impairment, bladder and urethral symptoms
Neželeni učinki hematurija, ledvična okvara, simptomi sečnega mehurja in sečnice
proteinuria, renal pain
proteinurija, ledvične bolečine
rash, pruritus
izpuščaj, srbenje
urticaria, psoriasis, ecchymosis and increased bruising, purpura, dermatitis and eczema, hair loss
urtikarija, psoriaza, ekhimoze in več podplutb, purpura, dermatitis in ekcem, izpadanje las
Musculoskeletal, connective tissue and
Bolezni mišično- skeletnega sistema in vezivnega tkiva
hypokalaemia, lipids increased, appetite disorders (including anorexia), hyperuricaemia
hipokalemija, zvišanje lipidov, motnje apetita (vključno z anoreksijo), hiperurikemija
hypercalcaemia, hypocalcaemia
hiperkalcemija, hipokalcemija
11 System Organ Class Infections and infestations
Infekcijske in parazitske bolezni
Frequency Common
pogosti
Adverse Reaction lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infections (including urinary tract infections), upper respiratory infection
okužbe spodnjih dihal (vključno s pljučnico in bronhitisom), virusne okužbe (vključno z gripo in okužbami s herpesom), kandidoza, bakterijske okužbe (vključno z okužbami sečil), okužbe zgornjih dihal
opportunistic infections (including tuberculosis, histoplasmosis), sepsis, abscess, joint infection, skin infection (including cellulitis and impetigo), superficial fungal infections (including skin, nail and foot)
oportunistične okužbe (vključno s tuberkulozo in histoplazmozo), sepsa, absces, okužba sklepa, okužba kože (vključno s celulitisom in impetigom), površinske glivične okužbe (vključno s kožo, nohti in stopali)
necrotising fasciitis, viral meningitis, diverticulitis, wound infection
nekrotizirajoči fasciitis, virusni meningitis, divertikulitis, okužba rane
skin papilloma
papilom na koži
(including cysts and polyps)
(vključno s cistami in polipi)
lymphoma, solid organ tumours (including breast, ovarian, testicular), malignant melanoma, squamous cell carcinoma of the skin
limfom, tumorji parenhimskih organov (vključno z dojkami, jajčniki in testisi), maligni melanom, ploščatocelični karcinom kože
General disorders and administration site conditions
11 Organski sistem Splošne težave in spremembe na mestu aplikacije
Very Common
Pogostnost zelo pogosti
injection site reaction (including pain, swelling, redness or pruritus)
Neželeni učinki reakcija na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo ali srbenjem)
chest pain, oedema, influenza like illness
bolečina v prsih, edemi, gripi podobna bolezen
systemic lupus erythematosus, angioedema, drug hypersensitivity
sistemski eritematozni lupus, angioedem, preobčutljivost na zdravila
serum sickness, seasonal allergy
serumska bolezen, sezonska alergija
hepatic enzymes increased
zvišani jetrni encimi
hepatic necrosis, hepatitis, hepatic steatosis, cholelithiasis, blood bilirubin increased
nekroza jeter, hepatitis, jetrna steatoza, holelitiaza, zvišana vrednost bilirubina v krvi
12 Injection site reactions
Spremembe na mestu injiciranja