natgillin/translations-raw huggingface dataset:
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 PedACR50/70/90 so bili 12. teden 90,3 %/61,3 %/38,7 % in 24. teden 83,3 %/73,3 %/36,7 %.
• It is normal to see a drop of liquid at the end of the needle
• Normalno je, da na koncu igle vidite kapljico tekočine.
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Humira, who are chronic carriers of this virus (i.e. surface antigen positive).
Reaktivacijo hepatitisa B so opažali pri bolnikih, ki so dobivali antagonist TNF (vključno z zdravilom Humira) in ki so bili kronični nosilci virusa (tj. pozitivni na površinski antigen).
This may mean there is an infection.
Te spremembe lahko pomenijo okužbo.
Clinical remission Clinical response (CR-100)
Klinični odziv (CR-100)
• If your child has moderate or severe heart failure.
• če ima vaš otrok zmerno ali hudo srčno popuščanje.
If your doctor determines that methotrexate is inappropriate, Humira can be given alone.
Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko zdravilo Humira dobivate samo.
• Your doctor should test you for HBV.
• Zdravnik vas mora testirati na HBV.
Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposureresponse relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Učinkovitost adalimumaba za zdravljenje mladostnikov s HS je napovedana na podlagi dokazane učinkovitosti in razmerja med izpostavljenostjo in odzivom pri odraslih bolnikih s HS ter verjetnosti, da so potek bolezni, patofiziologija in učinek zdravila bistveno podobni kot pri odraslih bolnikih, pri enaki ravni izpostavljenosti.
Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Humira (see section 4.4).
Oftalmologom se svetuje, da se pred začetkom zdravljenja z zdravilom Humira posvetujejo z ustreznim specialistom (glejte poglavje 4.4).
Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by Week 19.
Bolniki so bili kasneje deležni obveznega programa postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 19. tedna.
Phase OL-LI 16 weeks Ped ACR 30 response (n/N)
Faza Odprta uvajalna faza 16 tednov Odziv »Ped ACR« 30 (n/N)
In rare cases, these infections can be life-threatening.
V redkih primerih so lahko te okužbe smrtno nevarne.
In CD Study III, at Week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
V študiji Crohnove bolezni III je bilo v 4. tednu 58 % (499/854) bolnikov klinično odzivnih in so bili ocenjeni v primarni analizi.
The injection is complete when the yellow indicator has stopped moving.
Injiciranje je končano, ko se rumeni kazalnik neha premikati.
Should treatment be interrupted, Humira may be re-introduced as appropriate.
Če je treba zdravljenje prekiniti, je možno zdravljenje z zdravilom Humira znova uvesti, kakor je primerno.
The primary endpoint in RA studies VI and VII was injection site pain immediately after injection as measured by a 0-10 cm VAS.
Primarna končna točka študij revmatoidnega artritisa VI in VII je bila bolečina na mestu injiciranja takoj po injiciranju, merjena z vizualno analogno lestvico od 0 do 10 cm.
One hundred patients (n=100) from the Paediatric CD Study continued in an open-label long-term extension study.
Sto bolnikov (n = 100) iz študije Crohnove bolezni pri pediatričnih bolnikih je nadaljevalo v odprti dolgoročni podaljšani študiji.
Insert the needle all the way into the skin at about a 45degree angle with one quick, short motion.
Iglo v celoti zabodite v kožo pod kotom 45 stopinj s hitrim, kratkim gibom.
Results from the overall UC-II study population are shown in Table 18.
Rezultate celotne populacije v študiji UC-II prikazuje preglednica 18.
• high blood sugar
• visok krvni sladkor
• To reduce the chance of infection, wipe the injection site with the other alcohol pad.
• Za zmanjšanje možnosti okužbe obrišite injekcijsko mesto s priloženim alkoholnim zložencem.
Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at Week 8.
Klinično remisijo (opredeljeno kot ocena Mayo ≤ 2 in nobena podocena > 1) so ocenili 8. teden.
Improvement in quality of life was measured up to Week 156 (36 months) and improvement was maintained through that time.
Do 156. tedna (36. meseca) se je ocenjevalo izboljšanje kvalitete življenja, ki se je v tem času tudi ohranilo.
If active tuberculosis is diagnosed, Humira therapy must not be initiated (see section 4.3).
Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom Humira ne sme začeti (glejte poglavje 4.3).
Of those in clinical response at Week 4, 48% had been previously exposed to other TNFantagonists.
Od teh s kliničnim odzivom v 4. tednu jih je bilo 48 % prej izpostavljenih drugim TNF antagonistom.
Check the liquid in the pre-filled syringe.
Preverite tekočino v napolnjeni injekcijski brizgi.
The white needle sleeve is there to protect you from touching the needle.
Beli tulec je nameščen zato, da prepreči dotikanje igle.
Administration of Humira without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
Humira brez metotreksata je zvečala nastajanje protiteles, zvečala očistek in zmanjšala učinkovitost adalimumaba (glejte poglavje 5.1).
The frequency of serious infections among Humira treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Pri bolnikih nad 65 let, ki so prejemali zdravilo Humira, je bila pogostost resnih okužb večja (3,7 %) kot pri tistih pod 65 let starosti (1,5 %).
An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomologous monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Raziskava embrio-fetalne razvojne toksičnosti/perinatalnega razvoja je bila narejena pri opicah Cynomologous z odmerki 0,30 in 100 mg/kg (od 9 do 17 opic na skupino) in ni pokazala znakov okvare plodov zaradi adalimumaba.
The injection is complete when the yellow indicator stops moving.
Injiciranje je zaključeno, ko se rumeni indikator neha premikati.
Humira works by reducing this inflammation.
Humira deluje tako, da zmanjša tako vnetje.
Change the place that you inject each time so that you do not become sore in one area.
Mesto injiciranja vsakokrat zamenjajte, tako da se en predel ne bo razbolel.
Maintenance of clinical remission was evaluated in CD study III (CHARM).
Vzdrževanje klinične remisije so ovrednotili v študiji Crohnove bolezni III (CHARM).
Your symptoms may return if you stop using Humira.
Vaši simptomi se lahko povrnejo, če prenehate jemati zdravilo Humira.
Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.
Psoriaza v plakih lahko vpliva tudi na nohte, zaradi česar le-ti razpadejo, postanejo debelejši in se dvignejo od svojega ležišča, kar je lahko boleče.
Table 13 Efficacy Responses in Placebo-Controlled AS Study - Study I Reduction of Signs and Symptoms
Preglednica 13 - Odzivi učinkovitosti v študiji pri ankilozirajočem spondilitisu, kontrolirani s placebom - študija I Zmanjšanje znakov in simptomov
• steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
• steroidi in zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili.
The impact of long-term treatment with Humira on the development of autoimmune diseases is unknown.
Vpliv dolgoročnega zdravljenja z zdravilom Humira na nastanek avtoimunskih bolezni ni znan.
This risk may increase if you have problems with your lungs.
Tveganje je lahko večje, če imate težave s pljuči.
Your doctor may decide to stop treatment.
Vaš zdravnik se bo morda odločil, da vaše zdravljenje prekine.
Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated.
Zdravljenje z zdravilom Humira mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Humira indicirano.
The presence of one or more bubbles in the window is normal.
Normalno je, če v okencu opazite enega ali več mehurčkov.
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 zdravilo Humira, ni mogoče izključiti (glejte poglavje 4.8).
• tuberculosis
• tuberkulozo
The Humira pre-filled pen is available in packs containing:
Napolnjeni injekcijski peresnik zdravila Humira je na voljo v pakiranjih, ki vsebujejo:
1 sterile injection syringe 1 sterile needle
1 sterilna injekcijska brizga 1 sterilna igla
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 zdravila Humira prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
Results from the Short Form Health Survey (SF 36) for all doses/schedules of Humira in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Te izsledke podpirajo rezultati SF 36 (Short Form Health Survey) za vse odmerke/sheme zdravila Humira v vseh štirih študijah, s statistično značilnim seštevkom PCS (Physical Component Summary) in statistično značilnima seštevkoma za področje bolečin in vitalnosti za odmerek 40 mg vsak drugi teden.
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 anti-TNF zdravljenje ni bilo uspešno, jih je 52. teden doseglo remisijo 3 % na placebu in 10 % na adalimumabu.
A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid arthritis), was used.
mTSS), ki je vključil distalne interfalangealne sklepe (tj. ni bil enak TSS, ki se uporablja za revmatoidni artritis).
2) Choosing and preparing an injection site
2) Izbira in priprava injekcijskega mesta
Keep pressing and continue to hold the pre-filled pen with steady pressure in place for about 10 seconds to ensure a complete injection.
Napolnjeni injekcijski peresnik še naprej pritiskajte in držite s stalnim pritiskom na mestu približno 10 sekund, da bo injiciranje popolno.
10 Seconds
10 sekund
Turn the pre-filled pen so that the white arrow points toward the injection site.
Napolnjen injekcijski peresnik obrnite tako, da bela puščica kaže proti mestu injiciranja.
Patients treated with Humira had significantly reduced risk of disease flare during the initial 12 weeks of treatment.
Bolniki, zdravljeni z zdravilom Humira, so imeli signifikantno zmanjšanje tveganja novega izbruha bolezni v začetnih 12 tednih zdravljenja.
If your child has active tuberculosis, do not use Humira.
Če ima vaš otrok aktivno tuberkulozo, zdravila Humira ne smete uporabiti.
The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at Week 24 or 26.
Primarna končna točka v študijah revmatoidnega artritisa I, II in III ter sekundarna končna točka v študiji revmatoidnega artritisa IV je bil odstotek bolnikov, ki so po 24 oz. 26 tednih dosegli odziv 20 po ACR.
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 z zdravilom Humira pojavi nova okužba, je treba natančno nadzirati in opraviti morajo popolno diagnostično obravnavo.
Consequently, Humira can be used during breastfeeding.
Posledično se zdravilo Humira lahko uporablja med dojenjem.
Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Čeprav ni statistično značilno, je bilo pri večini bolnikov dokazano klinično izboljšanje sekundarnih opazovanih dogodkov, kot so število mest entezitisa, število občutljivih sklepov, število oteklih sklepov, odziv glede na merila Pediatric ARC 50 in Pediatric ARC
• Hold the syringe package and SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose (For example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).
• Držite ovojnino brizge in POČASI potegnite beli nosilec bata ven, tako da je 0,1 ml preko predpisanega odmerka (Če je npr. predpisani odmerek 0,5 ml, potegnite beli nosilec bata do
Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with Humira.
Študija nr-axSpA II je bila študija prenehanja zdravljenja pri bolnikih z aktivnim nr-axSpA, ki so med zdravljenjem z zdravilom Humira v odprti fazi zdravljenja dosegli remisijo.
Hold the pre-filled syringe in one hand.
Napolnjeno injekcijsko brizgo držite v eni roki.
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 z zdravilom Humira natančno kontrolirati glede okužb, vključno s tuberkulozo.
MTX = methotrexate P=0.027, Humira 0.8 mg/kg versus MTX P=0.083, Humira 0.8 mg/kg versus MTX
PGA: čisto/minimalnoc a MTX = metotreksat b P = 0,027, Humira 0,8 mg/kg v primerjavi z MTX c P = 0,083, Humira 0,8 mg/kg v primerjavi z MTX
There are no clinical trials with Humira in adolescent patients with HS.
Kliničnih študij z zdravilom Humira pri mladostnikih s HS ni.
Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Humira 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 Humira 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.
Alternatively, if a patient has stopped Humira and signs and symptoms of disease recur, Humira may be re-administered.
Če bolnik neha uporabljati zdravilo Humira, pa se znaki in simptomi bolezni ponovijo, je mogoče zdravilo Humira znova uvesti.
Slowly push the plunger in to push the air out through the needle.
Počasi pritiskajte na bat, da iz igle odstranite zrak.
Humira was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in Study UV I, and for general vision and mental health in Study UV II.
Številke so bile v korist zdravila Humira za večino podrezultatov s statistično značilno povprečno razliko za splošni vid, očesno bolečino, vid na blizu, duševno zdravje in skupen rezultat v študiji UV I, ter za splošni vid in duševno zdravje v študiji UV II.
The safety of Humira in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
Varnost zdravila Humira pri pediatričnih bolnikih s psoriazo v plakih je bila ocenjena za povprečno obdobje 13 mesecev.
The potential risk with the combination of azathioprine or 6-mercaptopurine and Humira should be carefully considered.
Potrebno je upoštevati potencialno tveganje pri sočasni uporabi azatioprina ali 6-merkaptopurina in zdravila Humira.
Slowly push the plunger all the way in until all of the liquid is injected and the pre-filled syringe is empty.
Počasi potisnite bat do konca, dokler ne injicirate celotne tekočine in je napolnjena injekcijska brizga prazna.
No clinical data are available on the use of a Humira loading dose in children < 6 years of age (see section 5.2).
Klinični podatki o uporabi polnilnega odmerka zdravila Humira pri otrocih, mlajših od 6 let, niso na voljo (glejte poglavje 5.2).
Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Zdravilo Humira je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
The yellow indicator is part of the plunger of the pre-filled pen.
Rumeni kazalnik je del bata napolnjenega peresnika.
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 zdravilo Humira lahko injicirajo sami, če zdravnik presodi, da je to primerno, in je zagotovljeno ustrezno medicinsko spremljanje.
Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Zdravilo Humira je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno (za učinkovitost monoterapije glejte poglavje 5.1).
Of those patients who had a response at Week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at Week 52.
Od bolnikov, ki so bili odzivni v 8. tednu, jih je bilo v 52. tednu 47 % odzivnih, 29 % v remisiji, 41 % je imelo celjenje sluznice in 20 % jih je bilo v remisiji brez steroidov za ≥ 90 dni.
Vision related effects were not numerically in favour of Humira 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 zdravila Humira v primeru barvnega vida v študiji UV I in v primeru barvnega vida, perifernega vida in vida na blizu v študiji UV II.
• Push plunger to inject solution - it can take from 2 to 5 seconds to empty the syringe
• Potisnite bat, da boste injicirali raztopino - za izpraznitev brizge utegne biti potrebnih od 2 do 5 sekund.
Patients treated with Humira should be given the Patient Reminder Card.
Bolniki, ki se zdravijo z zdravilom Humira, morajo dobiti posebno opozorilno kartico za bolnika.
Disease flare criteria were defined as a worsening of  30% from baseline in  3 of 6 Pediatric ACR core criteria,  2 active joints, and improvement of  30% in no more than 1 of the 6 criteria.
Merila zagona bolezni so bila opredeljena kot poslabšanje ≥ 3 od 6 osnovnih meril Pediatric ACR za ≥ 30 % v primerjavi z izhodiščem, ≥ 2 aktivna sklepa in izboljšanje ne več kot 1 od 6 meril za > 30 %.
No other disease-modifying anti-rheumatic drugs were allowed.
Uporaba drugih imunomodulirajočih antirevmatičnih zdravil ni bila dovoljena.
Safety of the recommended adalimumab dose in the adolescent HS population is based on cross-indication safety profile of adalimumab in both adults and paediatric patients at similar or more frequent doses (see section
Varnost priporočenega odmerka adalimumaba pri populaciji mladostnikov s HS temelji na varnostnem profilu indikacij adalimumaba pri odraslih in pediatričnih bolnikih pri podobnih ali pogostejših odmerkih (glejte poglavje 5.2).
• If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
• če je vaš otrok alergičen na adalimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
19.3% of patients had continued baseline oral antibiotic therapy during the study.
19,3 % bolnikov je nadaljevalo izhodiščno zdravljenje s peroralnimi antibiotiki.
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, povezane s HS, so ocenili s pomočjo numeričme ocenjevalne lestvice pri bolnikih, ki so imeli pri vključitvi v študijo izhodiščni rezultat 3 ali več na 11-stopenjski numerični ocenjevalni lestvici.
• Check that the small black needle cover of the syringe has been removed with the cap
• Preverite, da je bilo majhno, črno pokrivalo za iglo odstranjeno skupaj s pokrovčkom.
• haematoma (collection of blood outside of blood vessels)
• hematom (zbiranje krvi izven krvnih žil)
Antibiotics may be continued during treatment with Humira if necessary.
Humira lahko nadaljujete z antibiotičnim zdravljenjem, če je potrebno.
Do not use the pre-filled syringe and call your doctor or pharmacist if the
Ne uporabite napolnjene injekcijske brizge in pokličite zdravnika ali farmacevta, če
Psoriasis Study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Študija pri psoriazi I (REVEAL) je ocenila 1212 bolnikov v treh obdobjih zdravljenja.
If you have active tuberculosis, do not use Humira.
Če imate aktivno tuberkulozo, ne uporabljajte zdravila
PASI 75 PGA: Clear/minimal a
PGA: čisto/minimalno
Patients participating in all Phase 2 and Phase 3 psoriasis studies were eligible to enrol into an open-label extension trial, where Humira was given for at least an additional 108 weeks.
Bolniki, ki so sodelovali v študijah psoriaze 2. in 3. faze, so bili lahko vključeni v odprto podaljšano preskušanje, v katerem so zdravilo Humira prejemali vsaj še dodatnih 108 tednov.
• Your doctor should test your child for HBV.
• Zdravnik mora vašega otroka testirati na HBV.
Disease-related hospitalisations and surgeries were statistically significantly reduced with adalimumab compared with placebo at Week 56.
Z boleznijo povezane hospitalizacije in kirurški posegi so bili statistično pomembno zmanjšani pri adalimumabu v primerjavi s placebom v 56. tednu.
The corresponding proportions of patients with no radiographic progression were 31.3%, 23.7% and 36.7% respectively.
Ustrezni deleži bolnikov, ki niso imeli radiografskih znakov napredovanja, so bili 31.3 %, 23,7 % oz. 36,7 %.
• Set up the following items on a clean surface, DO NOTtake them out of their individual packaging yet.
• Na čisto površino pripravite sledeče enote zdravila in jih NE JEMLJITE iz njihove posamezne ovojnine:
Humira Δ Censored
Humira Δ anonimizirano
HR a CI 95% for HR
RTa IZ 95 % za RTa
In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through Week 520 (120 months) of open-label treatment.
V študiji revmatoidnega artritisa III se je pri večini bolnikov, ki so dosegli izboljšanje telesne funkcije in so nadaljevali zdravljenje, to izboljšanje ohranilo vseskozi do 520. tedna (120. meseca) odprte faze zdravljenja.
Humira demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA≥10% (60% of patients) and BSA<10% and ≥5% (40% of patients)).
Zdravilo Humira je pokazalo terapevtsko korist pri bolnikih s psoriazo nohtov z različnim obsegom prizadetosti kože (telesna površina ≥ 10 % (60 % bolnikov) in telesna površina < 10 % in ≥ 5 % (40 % bolnikov)).
There is a window on each side of the pen through which you can see the Humira solution inside the syringe.
Na obeh straneh peresnika je okence; skozi okenci lahko vidite raztopino zdravila Humira v notranjosti brizge.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
Throw the needle cover away.
Pokrovček igle zavrzite.