natgillin/translations-raw huggingface dataset:
For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Pri bolnikih, ki so pozitivni na okuţbo s hepatitisom B, se priporoča posvetovanje z zdravnikom specialistom za zdravljenje okuţb s hepatitisom B.
Clinical response (CR-100) was maintained in 102 and 233 patients, respectively.
Klinični odziv (CR-100) se je ohranil pri 102 oz. 233 bolnikih.
Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Z zdravjem povezano kakovost ţivljenja in telesno funkcijo so ocenjevali s pomočjo vprašalnikov HAQ-S in SF-36.
Solution for injection (injection).
Raztopina za injiciranje (injekcija).
Read all of this leaflet carefully before your child starts using this medicine because it contains important information.
Natančno preberite navodilo, preden vaš otrok začne uporabljati to zdravilo, ker vsebuje pomembne podatke!
The corresponding proportions of patients with no radiographic progression were 31.3%, 23.7% and 36.7% respectively.
Ustrezni deleţi bolnikov, ki niso imeli rentgenografskih znakov napredovanja, so bili 31,3 %, 23,7 % oz. 36,7 %.
Rare (may affect up to 1 in 1,000 people): • low blood measurements for white blood cells, red blood cells and platelet count.
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): • nizke vrednosti za bele krvne celice, rdeče krvne celice in trombocite.
Open your sharps disposal container so it is ready to use.
Zbiralnik za ostre predmete odprite, da je pripravljen za uporabo.
1.3 Remove the box from the refrigerator (Figure B).
1.3 Škatlo vzemite iz hladilnika (Slika B).
Approximately 40% of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Pri pribliţno 40 % bolnikih v študiji UC-II predhodno anti-TNF zdravljenje z infliksimabom ni bilo uspešno.
Study UV II
Študija UV II
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neţelenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).
• poslabšanje stanja, ki se imenuje dermatomiozitis (viden kot koţni izpuščaj, ki ga spremlja mišična šibkost).
In study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.
V študiji UV II so opazili statistično pomembne razlike samo za ostrino vida, toda tudi ostale komponente so bile glede številk v korist adalimumaba.
If retreatment with Kromeya is indicated, the above guidance on dose and treatment duration should be followed.
Če je indicirano vnovično zdravljenje z zdravilom Kromeya, je treba upoštevati zgoraj navedena navodila za odmerjanje in trajanje zdravljena.
After single intravenous doses ranging from 0.25 to 10 mg/kg, concentrations were dose proportional.
Po enem samem intravenskem odmerku od 0,25 do 10 mg/kg so bile koncentracije sorazmerne odmerku.
2-sided p value from log rank test.
2-stranska vrednost p testa log-rank.
Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Delni zagon bolezni je določen kot ASDAS ≥ 1,3 vendar < 2,1 pri dveh zaporednih obiskih.
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 primary non-responders were excluded from the studies and therefore these patients were not further evaluated.
Bolniki, ki se prvič niso odzvali, so bili izključeni iz študij in torej niso bili nadaljnje ovrednoteni.
Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Adalimumab je rekombinantno humano monoklonsko protitelo, pridobljeno v celicah jajčnika kitajskega hrčka.
Warning: Do not use the vial if:
Opozorilo: Vialo ne uporabljajte, če:
The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended dose.
Največji ocenjeni odmerek je obsegal večkratno intravensko aplikacijo 10 mg/kg, kar je pribliţno 15-kraten priporočen odmerek.
Therapy continued beyond 12 weeks did not result in significantly more responses (see section 4.2).
Nadaljevanje zdravljenja po 12. tednu ni pokazalo pomembno več odzivov (glejte poglavje 4.2).
Steroid-free remission for ≥ 90 days a
Remisija brez steroidov za ≥ 90 dni a
Your child's symptoms may return upon stopping treatment.
Simptomi vašega otroka se lahko po prekinitvi zdravljenja povrnejo.
2.3 Check the liquid to make sure that : The liquid is clear, colorless, and free of particles.
2.3 Preglejte tekočino in preverite, ali je : bistra, brezbarvna in brez delcev.
You and your doctor should pay special attention to signs of infection while you are being treated with Kromeya.
Vi sami in vaš zdravnik morata biti posebej pozorna na znake okuţbe, medtem ko ste zdravljeni z zdravilom Kromeya.
After adjustment for weight differences, gender and age appeared to have a minimal effect on adalimumab clearance.
Po korekciji za razlike v teţi se je izkazalo, da spol in starost po vsem sodeč minimalno vplivata na očistek adalimumaba.
Discontinued corticosteroids
Prenehanje s kortikosteroidi
Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, using the NEI VFQ-25.
Izidi poročil bolnikov glede opravil, povezanih z vidom, so bili merjeni v obeh kliničnih študijah z uporabo vprašalnika NEI VFQ -25.
TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer.
TNF-antagonisti, kot je adalimumab, prizadenejo imunski sistem in njihova uporaba lahko vpliva na obrambo telesa proti okuţbi in raku.
Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5% due to insufficient response to adalimumab treatment.
Med bolniki, ki so prekinili študijo pred 78. tednom, jih je 11 % prekinilo študijo zaradi neţelenih učinkov in 5 % zaradi nezadostnega odziva na zdravljenje z adalimumabom.
It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).
Priporočljivo je, da se vsako leto ocenijo koristi in tveganja nadaljnjega dolgotrajnega zdravljenja (glejte poglavje 5.1).
Treatment with Kromeya can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Zdravljenje z zdravilom Kromeya se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
During the study, most subjects used concomitant MTX, with fewer reporting use of corticosteroids or NSAIDs.
Med študijo je večina preiskovancev sočasno uporabljala metotreksat, manj pa jih je navedlo uporabo kortikosteroidov ali NSAIDs.
95% confidence intervals for the differences in change scores between methotrexate and adalimumab.
95 % intervali zaupanja za razlike v spremembi ocen med metotreksatom in adalimumabom na podlagi analize rangov zoţitev sklepne špranje
Your doctor may recommend temporarily stopping Kromeya.
Vaš zdravnik bo morda priporočil začasno prenehanje uporabe zdravila Kromeya.
The European Medicines Agency has deferred the obligation to submit the results of 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 odloţila zahtevo za predloţitev rezultatov študij z referenčnim zdravilom, ki vsebuje adalimumab za eno ali več podskupin pediatrične populacije z ulceroznim kolitisom, za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
Warning: Do not keep any unused medicine.
Opozorilo: Neuporabljenega zdravila ne shranjujte.
In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:
V primeru, ko je potreben hitrejši odgovor na zdravljenje, z teden zavedanjem, da je tveganje za pojav neţelenih učinkov povečano ob uporabi večjega začetnega odmerka, se lahko uporabi odmerek:
Week 26 Week 52 p value for Standard Dose versus Low Dose comparison.
26. teden 52. teden p vrednost za primerjavo standardnega odmerka proti majhnemu odmerku.
Formation of antiadalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Nastanek protiteles proti adalimumabu spremljata večji očistek in manjša učinkovitost adalimumaba.
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.
- if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na adalimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Patients in clinical response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Bolnike s kliničnim odzivom (zmanjšanje CDAI ≥ 70) v 4. tednu so preučili in analizirali ločeno od tistih brez kliničnega odziva v 4. tednu.
• On rare occasions, treatment with Kromeya could result in lupus-like syndrome.
• V redkih primerih lahko zdravljenje z zdravilom Kromeya povzroči lupusu podoben sindrom.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBINA, IZRAŢENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
Drugi primeri so obsegali številne različne malignome, med njimi redke malignome, ki so ponavadi povezani z imunosupresijo.
Your doctor may prescribe another strength of Kromeya if your child needs a different dose.
Zdravnik lahko predpiše vašemu otroku drugo jakost zdravila Kromeya, če vaš otrok potrebuje drugačen odmerek.
Full instructions for use are provided in the package leaflet.
Podrobna navodila za uporabo so navedena v navodilu za uporabo.
It can now be thrown away in the sharps container.
Sedaj jo lahko zavrţete v zbiralnik za ostre predmete.
BCVA was either improved or maintained (< 5 letters deterioration) in 88.4% of the eyes at week 78.
Najboljša korigirana ostrina vida se je ali izboljšala ali pa ohranila (poslabšanje ostrine vida < 5 črk) pri 88,4 % očeh v 78. tednu.
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 pribliţno 5 mesecev.
Percent change in total fingernail NAPSI (%)
Odstotek spremembe v celotnem indeksu NAPSI
• Children are not allowed to inject themselves and injection must be done by a trained adult.
• Otroci si zdravila ne smejo injicirati sami, temveč jim ga mora injicirati usposobljena odrasla oseba.
Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96% of those in serum.
Koncentracije adalimumaba v sinovijski tekočini več bolnikov z revmatoidnim artritisom so bile od 31 do 96 % tistih v serumu.
No dose adjustment is required.
Starejši Prilagoditev odmerka ni potrebna.
Of the 371 remaining patients, 276 evaluable patients reached 78 weeks of open-label adalimumab treatment.
Od preostalih 371 bolnikov je 276 ovrednotenih bolnikov zaključilo 78. tedensko odprto zdravljenje z adalimumabom.
In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients.
Na splošno so bili neţeleni učinki pri pediatričnih bolnikih po pogostnosti in vrsti podobni neţelenim učinkom, opaţenih pri odraslih bolnikih.
Other medicines and Kromeya
Druga zdravila in zdravilo Kromeya
Detailed instructions on how to inject Kromeya are provided in section 7 ‘Instructions for use'.
Podrobnejše informacije kako injicirati zdravilo Kromeya so opisane v poglavju 7 “Navodila za uporabo”.
Refer to package leaflet for alternative storage details.
Za podrobnosti alternativnega shranjevanja glejte navodilo za uporabo.
Exposure-response relationship in paediatric population
Razmerje med izpostavljenostjo in odzivom pri pediatrični populaciji
Corticosteroids or other medicines that influence the immune system may be continued while using Kromeya.
Kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem, se lahko še nadalje uporabljajo ob uporabi zdravila Kromeya.
After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 mL/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Po odmerkih 0,5 mg/kg (~40 mg) je bil očistek od 11 do 15 ml/uro, volumen distribucije (Vss) od 5 do 6 litrov in povprečni razpolovni čas terminalne faze pribliţno dva tedna.
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.
Deleţi preiskovancev s PedACR50/70/90 so bili 12. teden 90,3 %/61,3 %/38,7 % in 24. teden 83,3 %/73,3 %/36,7 %.
Step 2 Wash your hands
2. korak Umijte si roke
Patients on adalimumab may receive concurrent vaccinations, except for live vaccines.
Bolniki, ki prejemajo adalimumab, lahko sočasno dobijo cepiva, razen ţivih cepiv.
• Children under 12 years of age are not allowed to inject themselves and injection must be done by a trained adult.
• Otroci, mlajši od 12 let, si zdravila ne smejo injicirati sami, temveč jim ga mora injicirati usposobljena odrasla oseba.
The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Navidezna koncentracija adalimumaba v plazmi, ki doseţe polovico največje verjetnosti Ped ACR 50 odziva (EC50) je bila 3 μg/ml (95% IZ: 1-6 μg/ml).
Note: Treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as event.
Opomba: Neuspeh zdravljenja v ali po 6. tednu (študija UV I) ali v ali po 2. tednu (študija UV II) je bil štet kot dogodek.
PGA-F clear/minimal and ≥2-grade improvement (%)
PGA-F čisto/minimalno in ≥ izboljšanje za dva razreda (%)
An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomolgus 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.
• unusual infections (which include tuberculosis and other infections) that occur when resistance to disease is lowered;
• neobičajne okuţbe (vključujejo tuberkulozo in druge okuţbe, ki se pojavijo ob slabši telesni odpornosti na bolezen);
In the open-label period of the study, PASI 75 and PGA clear or minimal responses were maintained for up to an additional 52 weeks with no new safety findings.
V odprtem obdobju študije so se odzivi PASI 75 in PGA čisto ali minimalno ohranili še do dodatnih 52 tednov brez novih varnostnih ugotovitev.
HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.
HR adalimumaba v primerjavi s placebom iz regresije proporcionalnih tveganj z zdravljenjem kot faktorjem.
Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Kromeya.
Kortikosteroide, ki se jih daje sočasno, se lahko postopoma ukinja v skladu s klinično prakso, z začetkom dva tedna po začetku zdravljenja z zdravilom Kromeya.
Take a syringe out of the original box:
Injekcijsko brizgo vzemite iz originalne ovojnine:
Healthcare professionals are asked to report any suspected adverse reactions.
Zdravstvene delavce naprošamo, da poročajo o katerem koli domnevnem neţelenem učinku zdravila.
By attaching to TNFα, Kromeya blocks its action and reduces the inflammation in these diseases.
Z vezavo na TNFα zdravilo Kromeya zaustavi to aktivnost in zmanjša vnetje pri teh boleznih.
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 opaţali pri bolnikih, ki so dobivali antagonist TNF (vključno z adalimumabom) in ki so bili kronični nosilci virusa (tj. pozitivni na površinski antigen).
Patients who experience insufficient response may benefit from an increase in dosage:
Pri bolnikih, ki se ne odzovejo zadostno, se odmerek lahko poveča:
Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by week 19.
Bolniki so bili kasneje deleţni obveznega programa postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 19. tedna.
Erosion score JSN
Ocena erozij Seštevek JSN
Kromeya treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Kromeya is indicated.
Zdravljenje z zdravilom Kromeya mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Kromeya indicirano.
Adalimumab may cross the placenta into the serum of infants born to women treated with adalimumab during pregnancy.
Adalimumab lahko prehaja skozi placento v serum dojenčkov, ki so jih rodile ţenske, zdravljene z adalimumabom med nosečnostjo.
The Patient Reminder Cards (adult and paediatric) contain the following key elements: - infections, including tuberculosis - cancer - nervous system problems - vaccinations
Opozorilna kartica za bolnika (za odrasle in otroke) vsebuje naslednje ključne podatke: - okuţbe, vključno s tuberkulozo - rak - teţave ţivčnega sistema - cepljenja
- 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).
In patients with Crohn's disease, a reduction of the number of cells expressing inflammatory markers in the colon including a significant reduction of expression of TNFα was seen.
Pri bolnikih s Crohnovo boleznijo so opazili zmanjšanje števila celic, ki izraţajo vnetne označevalce v kolonu, vključno z bistvenim zmanjšanjem ekspresije TNFα.
• < 40 kg: 20 mg every week
• < 40 kg: 20 mg vsak teden
Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015
Odzivi »Ped ACR« 30/50/70 so bili 48. teden značilno večji kot pri bolnikih, ki so dobivali placebo b p = 0,015
• signs of skin cancer such as a bump or open sore that doesn't heal;
• znaki koţnega raka kot je bula ali odprta rana, ki se ne zaceli;
Population pharmacokinetic analyses with data from over 1300 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 teţe.
Tell your child's doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Obvestite otrokovega zdravnika ali farmacevta, če vaš otrok jemlje, je pred kratkim jemal ali pa bo morda začel jemati katero koli drugo zdravilo.
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 nekontrolirani dolgoročni podaljšek študij UV I in UV II, je bilo 46 bolnikov neprimernih (npr. razvili so se zapleti, sekundarno ob diabetični retinopatiji zaradi kirurškega posega sive mrene ali vitrektomije) in so bili izključeni iz primarne analize učinkovitosti.
Across all indications in clinical trials patients with raised ALT were asymptomatic and in most cases elevations were transient and resolved on continued treatment.
Bolniki z zvišanim ALT, ne glede na indikacijo v kliničnih preskušanjih, so bili asimptomatski in v večini primerov so bila zvišanja prehodna ter so izzvenela med nadaljnjim zdravljenjem.
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.
After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was slow, with peak serum concentrations being reached about 5 days after administration.
Po subkutani uporabi enega samega 40 mg odmerka sta bili absorpcija in distribucija adalimumaba počasni in največja koncentracija v serumu je bila doseţena pribliţno 5 dni po uporabi.
• pain in the muscles.
• bolečine v mišicah.
Kromeya in combination with methotrexate, is indicated for:
Zdravilo Kromeya je v kombinaciji z metotreksatom indicirano za:
Significant improvements at week 16 from baseline compared to placebo (Studies I and II) and MTX (study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Značilno izboljšanje od izhodišča do 16. tedna se je v primerjavi s placebom (študiji I in II) in metotreksatom (študija II) izkazalo v dermatološkem indeksu kakovosti ţivljenja (DLQIDermatology Life Quality Index).
• Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash);
• sindrom Stevens-Johnson (ţivljenjsko ogroţajoča reakcija z gripo podobnimi simptomi in mehurjastimi izpuščaji);
Thus additional caution should be exercised in considering Kromeya treatment of these patients (see section 4.8).
Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju z zdravilom Kromeya pri teh bolnikih (glejte poglavje 4.8).
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).
Before initiation of therapy with Kromeya, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Pred začetkom zdravljenja z zdravilom Kromeya je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okuţbe.
Fever, bruising, bleeding or looking pale
Vročina, podpludbe, krvavitev ali bledica
This will allow the needle to move up into the clear needle guard and cover the entire needle (Figure S).
Tako se bo injekcijska igla pomaknila v prozorno varovalo za iglo, ki jo bo v celoti prekril (Slika S).
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 %.
The frequency of serious infections among adalimumab 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 adalimumab, je bila pogostost resnih okuţb večja (3,7 %) kot pri tistih pod 65 let starosti (1,5 %).
Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Kromeya (see section 4.4).
Oftalmologom se svetuje, da se pred začetkom zdravljenja z zdravilom Kromeya posvetujejo z ustreznim specialistom (glejte poglavje 4.4).