natgillin/translations-raw huggingface dataset:
• DO NOT re-cap or touch the needle with your fingers, or let the needle touch anything.
• NE nameščajte pokrovčka nazaj na iglo in se ne dotikajte igle s svojimi prsti ter ne dovolite, da se igla česar koli dotakne.
Time to Treatment Failure At or After week 6 in Study UV I Primary analysis (ITT) Placebo Adalimumab Time to Treatment Failure At or After week 2 in Study UV II Primary analysis (ITT) Placebo Adalimumab
Čas do neuspeha zdravljenja v ali po 6. tednu v študiji UV I Primarna analiza (ITT) placebo adalimumab Čas do neuspeha zdravljenja v ali po 2. tednu v študiji UV II Primarna analiza (ITT) placebo adalimumab
• Certain vaccines contain living but weakened forms of bacteria or viruses that cause diseases and should not be given during treatment with Hulio in case they cause infections.
• Določena cepiva vsebujejo žive, a oslabljene oblike bakterij ali virusov, ki povzročajo bolezni, in se jih med zdravljenjem z zdravilom Hulio ne sme uporabljati, ker lahko povzročijo okužbe.
Concurrent administration of biologic DMARDS or TNF-antagonists
Sočasna uporaba bioloških antirevmatikov DMARD ali antagonistov TNF
After adjustment for weight differences, gender and age appeared to have a minimal effect on adalimumab clearance.
Po korekciji za razlike v masi se je izkazalo, da spol in starost po vsem sodeč minimalno vplivata na očistek adalimumaba.
Your child's doctor, nurse or other healthcare professional will show you how to prepare the injection and give it to your child.
Otrokov zdravnik, medicinska sestra ali drug zdravstveni delavec vam bo pokazal, kako pripraviti injekcijo in jo dati vašemu otroku.
ASAS Partial Remission BASDAIb 50
delna remisija ASAS BASDAIb 50
When you are sure the adapter is attached to the vial, lift off the packaging.
Ko ste prepričani, da je adapter nameščen na vialo, snemite ovojnino.
• 1 vial adapter (2)
• 1 adapter za vialo (2);
If your child has moderate or severe heart failure.
- če ima vaš otrok zmerno ali hudo srčno popuščanje.
Medication Orange Indicator
Oranžni kazalnik
The European Medicines Agency has deferred the obligation to submit the results of the studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij za referenčno zdravilo, ki vsebuje adalimumab, za eno ali več podskupin pediatrične populacije z ulceroznim kolitisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Travel/recurrent infection
Okužbe na potovanju/ponavljajoče se okužbe
This medicinal product contains sorbitol (E420).
To zdravilo vsebuje sorbitol (E420).
• mild allergic reactions (including seasonal allergy);
• blage alergijske reakcije (vključno s sezonskimi alergijami);
• signs of skin cancer such as a bump or open sore that doesn't heal;
• znake kožnega raka, kot so bula ali odprta rana, ki se ne zaceli;
Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Hulio.
Kortikosteroide, ki se jih daje sočasno, se lahko postopoma ukinja v skladu s klinično prakso, z začetkom dva tedna po začetku zdravljenja z zdravilom Hulio.
Tuberculosis can develop during therapy even if your child have had preventative treatment for tuberculosis.
Tuberkuloza se lahko razvije med zdravljenjem, tudi če je vaš otrok prejel preventivno zdravljenje za tuberkulozo.
The primary endpoint was ‘time to treatment failure'.
Primarni opazovani dogodek je bil ''čas do neuspeha zdravljenja''.
• If the plunger is not pressed all the way the safety feature will not activate afterwards to cover the needle.
• Če bata ne potisnete do konca, se po injiciranju ne bo aktiviral varnostni sistem, ki pokrije iglo.
Hypersensitivity, allergies (including seasonal allergy)
pogosti preobčutljivost, alergije (vključno s sezonsko alergijo)
Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN).
Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, študiji Crohnove bolezni I (CLASSIC I) in študiji Crohnove bolezni II (GAIN).
Tuberculosis can develop during therapy even if you have had preventative treatment for tuberculosis.
Tuberkuloza se lahko razvije med zdravljenjem, tudi če ste prejeli preventivno zdravljenje za tuberkulozo.
After proper training, the injection can be self-administered or given by another person, for example a family member or carer.
Po ustreznem urjenju si lahko injekcije dajete sami ali vam jih daje kdo drug, npr. svojec ali skrbnik.
PGA-F clear/minimal and ≥2-grade improvement (%)
PGA-F čisto/minimalno in izboljšanje za ≥ 2 razreda
• dry eyes, dry mouth;
• suhe oči, suha usta;
Efficacy Outcomes Double Blind 32 weeks Adalimumab /MTX (N = 38)
Rezultati učinkovitosti Dvojno slepa 32 tednov Adalimumab/MTX (N = 38)
• new or worsening psoriasis (red, flaky skin);
• pojav ali poslabšanje psoriaze (rdeča, luskava koža);
Adalimumab n=274 confidence interval)
adalimumab n = 274 interval zaupanja)
c Ankylosing Spondylitis Disease Activity Score d Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Score) d delni zagon bolezni je določen kot ASDAS ≥ 1,3, vendar < 2,1 pri 2 zaporednih obiskih.
During the withdrawal period, symptoms of psoriasis returned over time with a median time to relapse (decline to PGA “moderate” or worse) of approximately 5 months.
Med obdobjem prenehanja uporabe so se simptomi psoriaze sčasoma znova pojavili; mediani čas do ponovitve simptomov psoriaze (relapsa) (poslabšanje na PGA »zmerno« ali slabše) je bil približno 5 mesecev.
To help you remember which day(s) of the week Hulio should be injected, it may be helpful to make a note on a calendar or in a diary.
Da si boste lažje zapomnili, na kateri dan (dneve) v tednu morate injicirati zdravilo Hulio, je priporočljivo, da si to zapišete v koledar ali dnevnik.
Before initiation of therapy with Hulio, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Pred začetkom zdravljenja z zdravilom Hulio je treba vse bolnike pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
What Hulio is and what it is used for
Kaj je zdravilo Hulio in za kaj ga uporabljamo
• If the white plunger rod is pulled out of the syringe, discard the syringe and contact your Hulio provider for a replacement.
• Če beli nosilec bata potegnete iz brizge, brizgo zavrzite in se z dobaviteljem zdravila Hulio dogovorite za njeno nadomestitev.
• nerve damage;
• poškodba živcev;
Hulio treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Hulio is indicated.
Zdravljenje z zdravilom Hulio mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Hulio indicirano.
Of the 417 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Od 417 bolnikov, ki so bili vključeni v nekontrolirano podaljšano študijo UV I in UV II, je bilo 46 bolnikov neprimernih (npr. razvili so se zapleti, sekundarno ob diabetični retinopatiji zaradi operacije sive mrene ali vitrektomije) in so bili izključeni iz primarne analize učinkovitosti.
73% of patients enrolled in Psoriasis Studies I and II had received prior systemic therapy or phototherapy.
73 % bolnikov, vključenih v študiji psoriaze I in II, je predhodno dobivalo sistemsko zdravljenje ali fototerapijo.
Wipe the skin at the chosen injection site with a new alcohol swab.
Očistite kožo na izbranem injekcijskem mestu z novim alkoholnim zložencem.
b Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as nonresponders.
b Bolniki, ki izpolnjujejo merila, določena v protokolu, za izgubo odziva ali brez izboljšanja, so bili izključeni iz študij in so jih šteli kot bolnike brez odziva (»nonresponders«).
In the Viewing Window, the Orange Indicator will advance to show the progress of the injection.
V kontrolnem okencu boste videli pomikanje oranžnega kazalnika, ki kaže napredek injiciranja.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Natančno preberite to navodilo, preden vaš otrok začne uporabljati to zdravilo, ker vsebuje pomembne podatke zanj.
Reduction in HS-related skin pain was assessed using a Numeric Rating Scale in patients who entered the study with an initial baseline score of 3 or greater on a 11 point scale.
Zmanjšanje bolečine kože, povezane s HS, so ocenili s pomočjo numerične ocenjevalne lestvice pri bolnikih, ki so imeli pri vključitvi v študijo izhodiščni rezultat 3 ali več na 11-stopenjski numerični ocenjevalni lestvici.
Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Hulio (see section 4.4).
Oftalmologom se svetuje, da se pred začetkom zdravljenja z zdravilom Hulio posvetujejo z ustreznim specialistom (glejte poglavje 4.4).
Seek medical attention urgently if you develop any of the following signs of allergic reaction or heart failure:
Nemudoma poiščite zdravniško pomoč, če se pojavijo kateri koli od naslednjih znakov alergijske reakcije ali srčnega popuščanja:
Patients may first be given other medicines.
Bolniki bodo morda najprej prejeli druga zdravila.
Other medicines and Hulio
Druga zdravila in zdravilo Hulio
Firmly push the body of the pen down against the injection site to engage the Orange Activator and begin the injection.
Injekcijski peresnik čvrsto potisnite navzdol proti injekcijskemu mestu, da aktivirate oranžni aktivator in začnete z injiciranjem.
Find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give yourself or receive the injection.
Poiščite miren kraj z dobro osvetljeno, čisto in ravno delovno površino ter pripravite vse pripomočke, ki jih boste potrebovali, da si daste ali vam dajo injekcijo.
Side effects may occur up to 4 months or more after the last Hulio injection.
Neželeni učinki se lahko pojavijo do 4 mesece po zadnji injekciji zdravila Hulio ali kasneje.
Improvement in health-related quality of life and physical function was maintained during the open-label extension through week 156.
Izboljšanje z zdravjem povezane kakovosti življenja in telesne funkcije se je pri odprtih podaljšanjih študij ohranjalo do 156. tedna.
Solution for injection Multipack: 2 packs of 1 vial each.
raztopina za injiciranje Večkratno pakiranje: 2 pakiranji s po 1 vialo.
Supplies you will need:
Potrebujete naslednje pripomočke:
DO NOT pull the white plunger rod completely out of the syringe.
NE POTEGNITE belega nosilca bata popolnoma iz brizge.
Hulio contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Zdravilo Hulio vsebuje učinkovino adalimumab, zdravilo, ki učinkuje na imunski (obrambni) sistem telesa.
The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
Tarča adalimumaba je beljakovina, ki se imenuje tumorje nekrotizirajoči faktor (TNFα) in je prisotna v povečanih koncentracijah pri zgoraj navedenih vnetnih boleznih.
If active tuberculosis is diagnosed, Hulio therapy must not be initiated (see section 4.3).
Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom Hulio ne sme začeti (glejte poglavje 4.3).
If you do not have all the supplies you need, ask your nurse or pharmacist.
Če nimate vseh pripomočkov, ki jih potrebujete, zanje prosite medicinsko sestro ali farmacevta.
Do not mix any other medicine into the same syringe or vial with the Hulio solution.
Ne mešajte nobenega drugega zdravila v isti injekcijski brizgi ali viali z raztopino zdravila Hulio.
• 2 alcohol pads (4)
• 2 alkoholna zloženca (4);
Treatment with Hulio should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Zdravljenja z zdravilom Hulio se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
• DO NOT recycle your used sharps disposal container.
• Uporabljenega vsebnika za odlaganje ostrih predmetov NE RECIKLIRAJTE.
Adalimumab /MTX n=268 (95% confidence interval)
adalimumab/MTX n = 268 (95-% interval zaupanja)
Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
Nekaterim bolnikom, ki so bili uspešno zdravljeni zaradi aktivne tuberkuloze, se je med zdravljenjem z adalimumabom ponovno razvila tuberkuloza.
Some of those patients were also treated with the medicines azathioprine or mercaptopurine.
Nekateri od teh bolnikov so bili zdravljeni tudi z azatioprinom ali merkaptopurinom.
Study nr-axSpA II was a treatment withdrawal study in nr-axSpA patients who achieved remission during open-label treatment with adalimumab.
Študija nr-axSpA II je bila študija prenehanja zdravljenja pri bolnikih z nr-axSpA, ki so med zdravljenjem z adalimumabom v odprti fazi zdravljenja dosegli remisijo.
Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Hulio in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
O uporabi protituberkuloznega profilaktičnega zdravljenja morate pred uvedbo zdravila Hulio razmisliti tudi pri bolnikih s hudimi ali pomembnimi faktorji tveganja za tuberkulozo kljub negativnemu testu za tuberkulozo in pri bolnikih z anamnezo latentne ali aktivne tuberkuloze, pri katerih ni mogoče potrditi ustreznega zdravljenja.
fungal infections, joint infections);
glivičnimi okužbami, okužbami sklepov);
Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji ankilozirajočega spondilitisa II pri 82 odraslih bolnikih z aktivnim ankilozirajočim spondilitisom.
Of the 371 remaining patients, 276 evaluable patients reached 78 weeks of open-label adalimumab treatment.
Od preostalih 371 bolnikov je 276 za oceno primernih bolnikov zaključilo 78-tedensko odprto zdravljenje z adalimumabom.
Population pharmacokinetic analyses with data from over 1,300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Analize populacijske farmakokinetike s podatki za več kot 1300 bolnikov z revmatoidnim artritisom so pokazale trend k večjemu navideznemu očistku adalimumaba z večanjem telesne mase.
The combination of Hulio and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Kombinacija zdravila Hulio in anakinre ali abatacepta ni priporočljiva zaradi možnega povečanega tveganja za okužbe, vključno z resnimi okužbami, in drugih potencialnih farmakoloških interakcij.
Slowly push the plunger completely down until all the medicine is injected and the syringe is empty.
Počasi potisnite bat do konca, dokler ne injicirate vsega zdravila in je injekcijska brizga prazna.
If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Hulio, and in accordance with local recommendations.
Če ugotovite latentno tuberkulozo, morate pred uvedbo zdravila Hulio začeti s protituberkuloznim profilaktičnim zdravljenjem v skladu z lokalnimi priporočili.
Thus, additional caution should be exercised in considering adalimumab treatment of these patients (see section 4.8).
Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju z adalimumabom pri teh bolnikih (glejte poglavje 4.8).
In patients who develop HBV reactivation, Hulio should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Pri bolnikih, pri katerih se pojavi reaktivacija HBV, je treba uporabo zdravila Hulio prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
Patients treated with Hulio should be given the Patient Reminder Card.
Bolniki, ki se zdravijo z zdravilom Hulio, morajo dobiti opozorilno kartico za bolnike.
The primary efficacy endpoint in both studies was ´time to treatment failure´.
Primarni opazovani dogodek kot merilo učinkovitosti je bil v obeh študijah »čas do neuspeha zdravljenja«.
The decision to stop using Hulio should be discussed with your doctor.
O odločitvi, da bi prenehali uporabljati zdravilo Hulio, se morate posvetovati s svojim zdravnikom.
Find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give the injection.
Poiščite miren kraj z dobro osvetljeno, čisto in ravno delovno površino ter pripravite vse pripomočke, ki jih boste potrebovali za injiciranje.
Also contains: monosodium glutumate, sorbitol (E420), methionine, polysorbate 80, hydrochloric acid and water for injections.
Vsebuje tudi: mononatrijev glutamat, sorbitol (E420), metionin, polisorbat 80, klorovodikovo kislino in vodo za injekcije.
• 1 needle (5)
• 1 iglo (5).
In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
V predvidenem kohortnem registru je bilo vključenih 257 žensk z revmatoidnim artritisom (RA) ali Chronovo boleznijo (CB), zdravljenih z adalimumabom vsaj v prvem trimesečju nosečnosti, in 120 žensk z RA ali CB, ki niso bile zdravljene z adalimumabom.
Hulio contains sodium and sorbitol
Zdravilo Hulio vsebuje natrij in sorbitol.
BCVA was either improved or maintained (< 5 letters deterioration) in 88.4% of the eyes at week 78.
Najbolje korigirana ostrina vida se je ali izboljšala ali pa ohranila (poslabšanje ostrine vida < 5 črk) pri 88,4 % očeh v 78. tednu.
• 1 vial of Hulio solution (3)
• 1 vialo z raztopino zdravila Hulio (3);
Roll back any clothing that may interfere with the injection site.
Umaknite vsa oblačila, ki bi lahko ovirala dostop do injekcijskega mesta.
The active ingredient in Hulio, adalimumab, is a monoclonal antibody.
Učinkovina v zdravilu Hulio, adalimumab, je monoklonsko protitelo.
Chronic non-infectious uveitis affecting the front of the eye
Kronični neinfekcijski uveitis, ki prizadene sprednji del očesa
• acidity/acid reflux;
• hiperacidnost/refluks kisline;
Vision related effects were not numerically in favour of adalimumab for colour vision in Study UVI and for colour vision, peripheral vision and near vision in Study UV II.
Učinki, povezani z vidom, niso bili v korist adalimumaba v primeru barvnega vida v študiji UV I in v primeru barvnega vida, perifernega vida in vida na blizu v študiji UV II.
In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Hulio.
V primeru neinfekcijskega uveitisa se kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem, lahko še nadalje uporabljajo ob uporabi zdravila Hulio.
Among patients who had failed prior anti-TNF treatment, week 52 remission was achieved by 3% on placebo and 10% on adalimumab.
Med bolniki, pri katerih predhodno zdravljenje anti-TNF ni bilo uspešno, jih je 52. teden doseglo remisijo 3 % na placebu in 10 % na adalimumabu.
• worsening skin rash with muscle weakness.
• poslabšanje kožnega izpuščaja, ki ga spremlja mišična šibkost.
Step 2 - Wash hands
2. korak - Umijte si roki.
INFORMATION IN BRAILLE Hulio 40 mg
PODATKI V BRAILLOVI PISAVI Hulio 40 mg
Pull the syringe away from the injection site at the same angle as inserted and release your thumb from the plunger.
Injekcijsko brizgo izvlecite iz injekcijskega mesta pod enakim kotom, kot ste jo vstavili, in umaknite palec z bata.
The proportions of subjects with PedACR50/70/90 at week 12 and week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Deleži preiskovancev s Ped ACR 50/70/90 so bili 12. teden 90,3 %/61,3 %/38,7 % in 24. teden 83,3 %/73,3 %/36,7 %.
A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Hulio cannot be excluded (see section 4.8).
Tveganja za razvoj hepatospleničnega limfoma celic T pri bolnikih, ki prejemajo zdravilo Hulio, ni mogoče izključiti (glejte poglavje 4.8).
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Reaktivacijo hepatitisa B so opažali pri bolnikih, ki so prejemali antagonist TNF, vključno z adalimumabom, in ki so bili kronični nosilci tega virusa (tj. pozitivni na površinski antigen).
All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Vse bolnike z ulceroznim kolitisom, ki imajo večje tveganje za displazijo ali karcinom kolona (npr. bolnike z dolgotrajnim ulceroznim kolitisom ali primarnim sklerozirajočim holangitisom) ali imajo anamnezo displazije ali karcinoma kolona, je treba pred zdravljenjem in redno med potekom bolezni presejalno pregledovati glede displazije.
Improved physical function continued during the open label extension up to week 136.
Izboljšanje telesnega delovanja je trajalo še med odprtim podaljšanjem do 136. tedna.
Check with your healthcare provider for instructions on how to properly dispose of a filled sharps container.
Zdravstvenega delavca prosite za navodila, kako pravilno zavreči poln vsebnik za ostre predmete.
Hold the syringe at eye-level with the needle pointing up to see the amount of solution clearly.
Držite brizgo na ravni oči in z iglo obrnjeno navzgor, da boste jasno videli količino raztopine.
These infections have not consistently been recognised in patients taking TNFantagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Takšne okužbe pri uporabnikih antagonistov TNF niso bile dosledno prepoznane, zato je v primerih njihovega nastanka prihajalo do zamud pri ustreznem zdravljenju, kar je včasih povzročilo smrt.
It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
Zelo pomembno je, da zdravniku poveste, če ste kadar koli imeli tuberkulozo ali ste bili v tesnem stiku s kom, ki jo je imel.
You should record the date when the syringe is first removed from refrigerator, and the date after which it should be discarded.
Zapisati si morate datum, ko je bila brizga prvič vzeta iz hladilnika, in datum, po katerem jo je treba zavreči.
• DO NOT touch the top of the syringe.
• NE DOTIKAJTE se zgornjega dela brizge.
- The other ingredients are monosodium glutumate, sorbitol, methionine, polysorbate 80,
- Druge sestavine zdravila so mononatrijev glutamat, sorbitol, metionin, polisorbat 80,