natgillin/translations-raw huggingface dataset:
For polyarticular juvenile idiopathic arthritis, around 40% of the patients receiving Humira, either alone or in combination with methotrexate, had a flare-up of arthritis, compared with around 69% of those receiving placebo.
Poliartikularni juvenilni idiopatski artritis je ponovno izbruhnil pri približno 40% bolnikov, ki so prejemali zdravilo Humira bodisi samostojno ali v kombinaciji z metotreksatom, med bolniki, ki so prejemali placebo, je bolezen ponovno izbruhnila pri 69%.
However, fewer patients receiving Humira with methotrexate developed antibodies, so the results favoured the use of Humira with methotrexate over Humira used alone.
Manj bolnikov, ki so prejemali zdravilo Humira skupaj z metotreksatom, je razvilo protitelesa, zato so bili rezultati pri jemanju zdravila Humira skupaj z metotreksatom ugodnejši od rezultatov pri samostojnem jemanju zdravila Humira.
The fixed 40-mg dose, which is the only dose of Humira currently available, was considered to be suitable only for patients aged 13 years or above.
Stalni 40- miligramski odmerek, ki je edini odmerek, v katerem je zdravilo Humira trenutno na voljo, je veljal kot primeren za bolnike, stare 13 let ali več.
Humira also produced a greater improvement in symptoms than placebo in studies of psoriatic arthritis, ankylosing spondylitis, induction and maintenance phases of treatment for Crohn’ s disease, and psoriasis.
2/ 3 Pri uporabi zdravila Humira so se v primerjavi z uporabo placeba bolj zmanjšali simptomi pri študijah psoriatičnega artritisa, ankilozirajočega spondilitisa, indukcijske in vzdrževalne faze pri zdravljenju Crohnove bolezni ter psoriaze.
In studies of Humira, the most common side effect (seen in more than 1 patient in 10) was injection site reactions (including pain, swelling, redness or itching).
V študijah zdravila Humira so bili najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) reakcije na mestu vbrizganja (vključno z bolečino, otekanjem, rdečino ali srbenjem).
Due to an increased risk of infection, patients taking Humira must be monitored closely for infections including tuberculosis during and for 2/ 3 up to five months after treatment.
Zaradi povečanega tveganja okužbe je treba med zdravljenjem z zdravilom Humira in do pet mesecev po zaključku le- tega bolnike skrbno opazovati zaradi morebitnih okužb, ki vključujejo tudi tuberkulozo.
For the full list of all side effects reported with Humira, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Humira, glejte navodilo za uporabo.
Humira should not be used in people who may be hypersensitive (allergic) to adalimumab or any of the other ingredients.
Zdravila Humira ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) adalimumab ali katero koli drugo sestavino zdravila.
Humira must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Zdravilo Humira se ne sme uporabljati pri bolnikih s tuberkulozo, drugimi hudimi boleznimi ali zmerno do hudo obliko popuščanja srca (nezmožnost srca, da načrpa dovolj krvi in telesu zagotovi zadosten dotok kisika in hranljivih snovi).
The Committee for Medicinal Products for Human Use (CHMP) decided that Humira’ s benefits are greater than its risks for treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease and psoriasis.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristni učinki zdravila Humira večji od z njim povezanih tveganj pri zdravljenju zmernega do hudega revmatoidnega artritisa, poliartikularnega juvenilnega idiopatskega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa, Crohnove bolezni in psoriaze.
The Committee recommended that Humira be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Humira odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Humira?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Humira?
The company that makes Humira will provide educational packs for doctors who will prescribe Humira.
Družba, ki izdeluje zdravilo Humira, bo priskrbela izobraževalne brošure za zdravnike, ki bodo predpisovali zdravilo Humira.
These packs will include information on the safety of the medicine.
Te brošure bodo vključevale informacije o varnosti zdravila.
Other information about Humira:
Druge informacije o zdravilu Humira:
The European Commission granted a marketing authorisation valid throughout the European Union for Humira to Abbott Laboratories Ltd. on 8 September 2003.
Evropska komisija je dovoljenje za promet z zdravilom Humira, veljavno po vsej Evropski uniji, odobrila družbi Abbott Laboratories Ltd. dne 8. septembra 2003.
The marketing authorisation was renewed on 8 September 2008.
Dovoljenje za promet je bilo obnovljeno 8. septembra 2008.
The full EPAR for Humira can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Humira je na voljo tukaj.
Pharmaceutical Form
oblika
1 vial + 1 syringe + 2 alcohol pads
1 viala + 1 injekcijska brizga + 2 alkoholna zloženca
1 pre-filled syringe + 1 alcohol pad
1 napolnjena injekcijska brizga + 1 alkoholni zloženec
2 pre-filled syringes + 2 alcohol pads
2 napolnjeni injekcijski brizgi + 2 alkoholna zloženca
4 pre-filled syringes + 4 alcohol pads
4 napolnjene injekcijske brizge + 4 alkoholni zloženci
6 pre-filled syringes + 6 alcohol pads
6 napolnjenih injekcijskih brizg + 6 alkoholnih zložencev
EMEA Number
Farmacevtska
Strength
Številka postopka EMEA
Pharmaceutical Form
Izmišljeno ime Jakost
EMEA/ H/ C/ 000481/ II/ 0030/ 007
EMEA/ H/ C/ 000481/ II/ 0030/ 007
40 mg
Humira 40 mg
1 pre-filled pen + 1 alcohol pad in a blister
1 napolnjen injekcijski peresnik + 1 alkoholni zloženec
2 pre-filled pens + 2 alcohol pads in a blister
2 napolnjena injekcijska peresnika + 2 alkoholna zloženca
4 pre-filled pens + 4 alcohol pads in a blister
4 napolnjeni injekcijski peresniki + 4 alkoholni zloženci
6 pre-filled pens + 6 alcohol pads in a blister
6 napolnjenih injekcijskih peresnikov + 6 alkoholnih zložencev
Humira 40 mg solution for injection.
Humira 40 mg raztopina za injiciranje
Each 0.8 ml single dose vial contains 40 mg of adalimumab.
Ena 0, 8 ml viala z enim odmerkom vsebuje 40 mg adalimumaba.
Clear solution for injection.
Bistra raztopina za injiciranje
Humira in combination with methotrexate, is indicated for:
Humira je v kombinaciji z metotreksatom indicirana za:
 the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.  the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še niso dobivali metotreksata.
Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Humiro je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljne zdravljenje z metotreksatom ni primerno.
Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Z rentgenskim slikanjem je bilo dokazano, da Humira upočasni hitrost napredovanja prizadetosti sklepov in izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in adolescents aged 13 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Humira je v kombinaciji z metotreksatom indicirana za zdravljenje aktivnega poliartikularnega juvenilnega idiopatskega artritisa pri mladostnikih, starih od 13 do 17 let, ki se ne odzovejo ustrezno na eno ali več imunomodulirajočih antirevmatičnih zdravil.
Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (see section 5.1).
Humiro je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljne zdravljenje z metotreksatom ni primerno (glejte poglavje 5. 1).
Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Humira je indicirana za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function.
Z rentgenskim slikanjem je bilo dokazano, da Humira upočasni hitrost napredovanja prizadetosti perifernih sklepov pri bolnikih s poliartikularno, simetrično podvrsto bolezni (glejte poglavje 5. 1) in izboljša telesno funkcijo.
2 Ankylosing spondylitis
2 Ankilozirajoči spondilitis
Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Humira je indicirana za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
Crohn’ s disease
Crohnova bolezen
Humira is indicated for treatment of severe, active Crohn’ s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/ or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Humira je indicirana za zdravljenje hude, aktivne Crohnove bolezni pri bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
For induction treatment, Humira should be given in combination with corticosteroids.
Za indukcijsko zdravljenje morate Humiro uporabiti v kombinaciji s kortikosteroidi.
Humira can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).
V primeru intolerance za kortikosteroide ali kadar nadaljnje zdravljenje s kortikosteroidi ni primerno, lahko Humiro uporabite tudi v monoterapiji (glejte poglavje 4. 2).
Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA.
Humira je indicirana za zdravljenje zmerne do hude kronične psoriaze v plakih pri odraslih bolnikih, ki se ne odzovejo na druge sistemske terapije (vključno s ciklosporinom, metotreksatom ali terapijo PUVA (kombinacija zdravila psoralen in obsevanja z UVA žarki)) ali imajo kontraindikacije zanje.
Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease or psoriasis.
Zdravljenje s Humiro mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju revmatoidnega artritisa, poliartikularnega juvenilnega idiopatskega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa, Crohnove bolezni ali psoriaze.
Patients treated with Humira should be given the special alert card.
Bolniki, ki se zdravijo s Humiro, morajo dobiti posebno opozorilno izkaznico.
After proper training in injection technique, patients may self-inject with Humira if their physician determines that it is appropriate and with medical follow-up as necessary.
Bolniki, ki se naučijo pravilnega postopka injiciranja, si Humiro lahko injicirajo sami, če zdravnik presodi, da je to primerno, in je zagotovljeno ustrezno medicinsko spremljanje.
During treatment with Humira, other concomitant therapies (e. g., corticosteroids and/ or immunomodulatory agents) should be optimised.
Med zdravljenjem s Humiro je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ ali imunomodulacijska zdravila).
Dose Interruption
Prekinitev odmerjanja
Available data suggest that re-introduction of Humira after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Če se uporaba zdravila Humira prekine za 70 dni ali več, razpoložljivi podatki kažejo, da ponovna uvedba zdravila Humira privede do kliničnega odziva v enakih obsegih in do podobnega varnostnega profila kot pred prekinitvijo odmerjanja.
The recommended dose of Humira for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek Humire za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
Methotrexate should be continued during treatment with Humira.
Med zdravljenjem s Humiro je treba še naprej uporabljati metotreksat.
Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Humira.
Med zdravljenjem s Humiro je mogoče nadaljevati z uporabo glukokortikoidov, salicilatov, nesteroidnih protivnetnih zdravil ali analgetikov.
Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Za kombinirano uporabo z drugimi imunomodulirajočimi zdravili razen metotreksata glejte poglavji 4. 4 in 5. 1.
3 Psoriatic arthritis and ankylosing spondylitis
3 Psoriatični artritis in ankilozirajoči spondilitis
The recommended dose of Humira for patients with psoriatic arthritis or ankylosing spondylitis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočen odmerek Humire pri bolnikih s psoriatičnim artritisom ali ankilozirajočim spondilitisom je 40 mg adalimumaba, apliciran v enkratni subkutani injekciji vsak drugi teden.
The recommended Humira induction dose regimen for adult patients with severe Crohn’ s disease is 80 mg at Week 0 followed by 40 mg at Week 2.
Priporočena shema odmerjanja Humire med indukcijo je pri odraslih bolnikih s hudo Crohnovo boleznijo 80 mg 0. teden in nato 40 mg 2. teden.
In case there is a need for a more rapid response to therapy, the regimen 160 mg at Week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at Week 2, can be used with the awareness that the risk for adverse events is higher during induction.
Ob tem se morate zavedati, da je tveganje za neželene učinke med indukcijo večje.
Alternatively, if a patient has stopped Humira and signs and symptoms of disease recur, Humira may be re-administered.
Če bolnik neha uporabljati Humiro, pa se znaki in simptomi bolezni ponovijo, je mogoče Humiro znova uvesti.
Some patients who experience decrease in their response may benefit from an increase in dose intensity to 40 mg Humira every week.
Nekaterim bolnikom, ki se jim odziv zmanjša, lahko koristi povečanje odmerka Humire na 40 mg vsak teden.
The recommended dose of Humira for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Priporočeno odmerjanje Humire za odrasle bolnike je začetni odmerek 80 mg subkutano, ki mu sledi 40 mg subkutano čez en teden in nato 40 mg subkutano vsak drugi teden.
Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.
Če se bolnik v obdobju 16 tednov ne odzove, morate dobro pretehtati, preden nadaljujete zdravljenje.
Children and adolescents (aged 13 to 17 years)
Otroci in mladostniki (stari od 13 do 17 let)
Polyarticular Juvenile Idiopathic Arthritis The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, aged 13 years and above is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek Humire za bolnike s poliartikularnim juvenilnim idiopatskim artritisom, stare nad 13 let, je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
4 Impaired renal and/ or hepatic function
Okvarjeno delovanje ledvic in/ ali jeter
No dose recommendations can be made.
Humira pri teh populacijah bolnikov še ni bila preskušena, zato priporočil za odmerjanje ni mogoče dati.
4.3 Contraindications
4 4. 3 Kontraindikacije
Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section 4.4).
Aktivna tuberkuloza ali druge hude okužbe, npr. sepsa, in oportunistične okužbe (glejte poglavje 4. 4).
Moderate to severe heart failure (NYHA class III/ IV) (see section 4.4).
Zmerno do hudo srčno popuščanje (razred III/ IV po NYHA) (glejte poglavje 4. 4).
Patients taking TNF-blockers are more susceptible to serious infections.
Bolniki, ki uporabljajo zaviralce TNF, so bolj dovzetni za resne okužbe.
Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Humira.
Bolnike je zato treba pred, med in po zdravljenju s Humiro natančno kontrolirati glede okužb, vključno s tuberkulozo.
Treatment with Humira should not be initiated in patients with active infections including chronic or localized infections until infections are controlled.
Zdravljenja s Humiro se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Humira should be considered prior to initiating therapy (see Opportunistic infections).
Pred začetkom zdravljenja je treba tveganja in koristi zdravljenja s Humiro pretehtati pri bolnikih, ki so bili izpostavljeni tuberkulozi, in bolnikih, ki so potovali na območja, kjer obstaja veliko tveganje tuberkuloze ali endemičnih mikoz, npr. histoplazmoze, kokcidioidomikoze ali blastomikoze (glejte Oportunistične okužbe).
Patients who develop a new infection while undergoing treatment with Humira should be monitored closely and undergo a complete diagnostic evaluation.
Bolnike, pri katerih se med zdravljenjem s Humiro pojavi nova okužba, je treba natančno nadzirati in opraviti morajo popolno diagnostično obravnavo.
Administration of Humira should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Če se bolniku pojavi nova resna okužba ali sepsa, je treba uporabo Humire prekiniti in uvesti ustrezno protimikrobno ali protimikotično zdravljenje, dokler okužba ni obvladana.
Physicians should exercise caution when considering the use of Humira in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Pri odločanju za uporabo Humire je potrebna previdnost pri bolnikih z anamnezo ponavljajoče se okužbe ali z osnovnimi boleznimi, ki lahko zvečajo nagnjenost k okužbam, vključno s sočasno uporabljenimi imunosupresivnimi zdravili.
Serious infections,, including sepsis, due to bacterial, mycobacterial, invasive fungal viral, or other opportunistic infections such as listeriosis, and pneumocystis have been reported in patients receiving Humira.
Pri bolnikih, ki so dobivali Humiro, so bile opisane resne okužbe, vključno s sepso, zaradi bakterijskih, mikobakterijskih, invazivnih glivičnih, virusnih in drugih oportunističnih okužb, npr. listerioza in pnevmocistična okužba.
Hospitalisation or fatal outcomes associated with infections have been reported.
Med drugimi resnimi okužbami, zabeleženimi v kliničnih preskušanjih, so bile pljučnica, pielonefritis, septični artritis in septikemija. Opisane so bile hospitalizacije in smrti zaradi okužb.
There have been reports of tuberculosis in patients receiving Humira.
Pri bolnikih, zdravljenih s Humiro, so bili opisani primeri tuberkuloze.
It should be noted that in the majority of those reports, tuberculosis was extra-pulmonary, i. e. disseminated.
Opozoriti je treba, da je bila v večini teh primerov tuberkuloza zunajpljučna, tj. diseminirana.
Before initiation of therapy with Humira, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
Pred začetkom zdravljenja s Humiro je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
This evaluation should include a detailed medical history of patients with a personal history of tuberculosis or possible previous exposure to patients with active tuberculosis and previous and/ or current immunosuppressive therapy.
Pregled mora obsegati podrobno zdravstveno anamnezo bolnikov z osebno anamnezo tuberkuloze ali morebitnih predhodnih stikov z bolniki z aktivno tuberkulozo ter predhodnega in/ ali trenutnega imunosupresivnega zdravljenja.
Appropriate screening tests, i. e. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may
Pri vseh bolnikih je treba narediti ustrezne presejalne preiskave, tj. tuberkulinski kožni test in rentgensko slikanje prsnih organov (veljajo lahko lokalna priporočila).
If active tuberculosis is diagnosed, Humira therapy must not be initiated (see section 4.3).
Če se odkrije aktivna tuberkuloza, se zdravljenja s Humiro ne sme začeti (glejte poglavje 4. 3).
If latent tuberculosis issuspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Če sumite na latentno tuberkulozo, se posvetujte z zdravnikom, ki ima izkušnje z zdravljenjem tuberkuloze.
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 s Humiro zelo natančno pretehtati.
If inactive (‘ latent’) tuberculosis is diagnosed, appropriate treatment for latent tuberculosis must be started with anti-tuberculosis prophylaxis therapy before the initiation of Humira, and in accordance with local recommendations.
5 Če ugotovite neaktivno (“ latentno ”) tuberkulozo, morate pred uvedbo Humire začeti zdraviti latentno tuberkulozo s protituberkulozno profilaktično terapijo v skladu z lokalnimi priporočili.
In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, anti-tuberculosis therapy should also be considered before the initiation of Humira.
Protituberkulozna terapija pride pred uvedbo Humire v poštev tudi pri bolnikih, ki imajo več dejavnikov tveganja ali pomembne dejavnike tveganja za tuberkulozo ter negativen test za latentno tuberkulozo.
Use of anti-tuberculosis therapy should also be considered before the initiation of Humira in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
O uporabi protituberkulozne terapije morate pred uvedbo Humire razmisliti tudi pri bolnikih z anamnezo latentne ali aktivne tuberkuloze, pri katerih ni mogoče potrditi ustreznega zdravljenja.
Some patients who have previously received treatment for latent or active tuberculosis have developed active tuberculosis while being treated with Humira.
Nekaterim bolnikom, ki so bili v preteklosti zdravljeni zaradi latentne ali aktivne tuberkuloze, se je med terapijo s Humiro razvila aktivna tuberkuloza.