natgillin/translations-raw huggingface dataset:
At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [p = 0.014]).
V 16. tednu je statistično pomembno večji deleţ bolnikov, ki so prejemali adalimumab, doseglo PGA „„čisto‟‟ ali „„skoraj čisto‟‟ za dlani in/ali stopala, v primerjavi z bolniki, ki so prejemali placebo (30,6 % proti 4,3 %, v tem zaporedju [p = 0,014]).
Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and adalimumab monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Po 52 oz. 104 tednih zdravljenja je bil v skupini s kombinirano terapijo z adalimumabom in metotreksatom odstotek bolnikov brez napredovanja bolezni (sprememba prilagojene Sharpove ocene od izhodišča ≤ 0,5) značilno večji (63,8 % oz. 61,2 %) kot v skupinah, ki sta prejemali monoterapijo z metotreksatom (37,4 % in 33,5 %, p < 0,001) ali monoterapijo z adalimumabom (50,7 %, p < 0,002, oz. 44,5 %, p < 0,001).
At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [P = 0.014]).
V 16. tednu je statistično pomembno večji deleţ bolnikov, ki so prejemali adalimumab, doseglo PGA „‟čisto‟‟ ali „‟skoraj čisto‟‟ za dlani in/ali stopala, v primerjavi z bolniki, ki so prejemali placebo (30,6 % proti 4,3 %, v tem zaporedju [P = 0.014]).
• With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (Figure P).
• S kratkim, hitrim gibom potisnite celo injekcijsko iglo v koţo pod kotom od 45° do 90°
Maintenance of remission and response rates are presented in Table 21.
Stopnje vzdrţevanja remisije in odziva so prikazani v preglednici 21.
CI 95% for HR
IZ 95 % P
If you accidentally inject a smaller amount of Kromeya liquid, or if you inject Kromeya less frequently than told to by your child's doctor or pharmacist, you should call your child's doctor or pharmacist and tell him/her that your child has taken less.
Če pomotoma injicirate manjši odmerek zdravila Kromeya, ali če zdravilo Kromeya injicirate manj pogosto, kot vam je naročil otrokov zdravnik, se morate posvetovati z njim ali s farmacevtom in mu povedati, da je otrok dobil manjši odmerek.
The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD combined.
Prilagojeno razmerje obetov (z ozirom na izhodiščne razlike) je bilo 1.10 (95 % interval zaupanja 0,45-2,73) z RA in CB skupaj.
The pivotal controlled studies involved 6,089 patients receiving adalimumab and 3,801 patients receiving placebo or active comparator during the controlled period.
Kontrolirane študije, ki podpirajo vlogo za pridobitev dovoljenja za promet, so vključevale 6089 bolnikov, ki so med kontroliranim obdobjem dobivali adalimumab, in 3801 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51%) were in remission at week 52.
V študiji UC-II je bilo 21/41 bolnikov (51 %), ki so bili zdravljeni z adalimumabom in so dosegli remisijo 8. teden, v remisiji 52. teden.
The safety and efficacy of adalimumab were assessed in a multicenter, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Varnost in učinkovitost adalimumaba so ocenili v multicentrični, randomizirani, dvojno slepi študiji pri 46 pediatričnih bolnikih (starih od 6 do 17 let) z zmernim artritisom, povezanim z entezitisom.
Week 2
2. teden
Hospitalisation or fatal outcomes associated with infections have been reported.
Opisane so bile hospitalizacije in smrti zaradi okuţb.
Tell your doctor immediately if your child gets symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.
Zdravniku takoj povejte, če je vaš otrok dobil simptome, kot so spremembe vida, šibkost rok ali nog ali pa odrevenelost ali mravljinčenje v katerem koli delu telesa.
Study UV I
Študija UV I
If these medicines do not work well enough, you will be given Kromeya to treat your rheumatoid arthritis.
Če ta zdravila ne delujejo dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili zdravilo Kromeya.
In the post marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Med obdobjem trţenja so bili opisani primeri levkemije pri bolnikih, zdravljenih z antagonistom TNF.
Very Common
Skupno je bilo
If you use more Kromeya than you should
Če ste uporabili večji odmerek zdravila Kromeya, kot bi smeli
If you think your child may be pregnant or is planning to have a baby, ask your doctor or pharmacist for advice before they use this medicine.
Če menite, da bi lahko bil vaš otrok noseč ali načrtuje nosečnost, se glede uporabe tega zdravila posvetujte s svojim zdravnikom ali farmacevtom.
Always take the outer carton or the vial of the medicine with you, even if it is empty.
Vedno vzemite s seboj zunanjo ovojnino ali vialo zdravila, tudi če je prazna.
• psoriatic arthritis,
• psoriatični artritis,
Choose a different injection site (at least 2.5 centimeters away from the previous injection site) each time to reduce redness, irritation or other skin problems.
Vsakič izberite drugo mesto (ki je vsaj 2,5 centimetra oddaljeno od prejšnjega), da bi zmanjšali pordelost, draţenje in druge teţave s koţo.
If you take Kromeya the risk of getting lymphoma, leukaemia, or other cancers may increase.
Če uporabljate zdravilo Kromeya, se vam lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
• Place the pre-filled pen against your skin at a 90° angle (Figure N).
• Napolnjen injekcijski peresnik postavite na koţo pod kotom 90° (Slika N).
Methotrexate should be continued during treatment with Kromeya.
Med zdravljenjem z zdravilom Kromeya je treba še naprej uporabljati metotreksat.
No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab.
Podatkov o sekundarnem prenosu okuţbe z ţivimi cepivi pri bolnikih, zdravljenih z adalimumabom, ni.
In RA studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg/dl) values) improved at 24 or 26 weeks compared to placebo.
V študijah revmatoidnega artritisa I-IV so se v primerjavi s placebom po 24 oz. 26 tednih izboljšali vsi posamezni elementi meril odziva po ACR (število bolečih in oteklih sklepov, zdravnikova in bolnikova ocena aktivnosti bolezni in bolečin, vrednost indeksa invalidnosti (HAQ) in vrednost CRP (mg/dl)).
This will include a thorough medical evaluation including your child's medical history and screening tests (for example chest X-ray and a tuberculin test).
To bo vključevalo natančno zdravniško oceno vključno s poizvedbo o zdravju vašega otroka v preteklosti in preiskave (npr. rentgensko slikanje prsnih organov in tuberkulinski test).
No patients developed lupus nephritis or central nervous system symptoms.
Pri nobenem bolniku se niso pojavili lupusni nefritis ali simptomi s strani osrednjega ţivčevja.
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Age or body weight
Revmatoidni artritis, psoriastični artritis, ankilozirajoči spondilitis ali aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči spondilitis Starost ali telesna masa
The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Varnost in učinkovitost adalimumaba sta bili ocenjeni v randomizirani, dvojno slepi, kontrolirani študiji pri 90 pediatričnih bolnikih, starih od 2 do manj kot 18 let, z aktivnim neinfekcijskim anteriornim uveitisom, povezanim z juvenilnim idiopatskim artritisom, ki se niso odzvali na zdravljenje z metotreksatom, ki je trajalo vsaj 12 tednov.
Warning: Do not touch the needle.
Opozorilo: Ne dotikajte se igle.
Number of patients at Baseline n (%)
Izhodiščno število bolnikov n (%)
If you forget to give yourself an injection, you should inject the next dose of Kromeya as soon as you remember.
Če si pozabite dati injekcijo, si morate naslednji odmerek zdravila Kromeya injicirati, čim se spomnite.
A total of 76.5% (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1%[123/178] and 88.8% [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Od bolnikov, deleţnih ponovnega zdravljenja, jih je skupno 76,5 % (218/285) po 16 tednih ponovnega zdravljenja imelo odziv PGA "čisto" ali "minimalno", ne glede na to, ali je med prenehanjem uporabe prišlo do relapsa (69,1 % [123/178] bolnikov, pri katerih je med prenehanjem uporabe prišlo do relapsa, in 88,8 % [95/107] tistih, pri katerih ni prišlo do relapsa).
In the pivotal controlled trials in adults and children, 12.9% of patients treated with adalimumab developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
V kontroliranih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, pri odraslih in otrocih je reakcije na mestu injiciranja (eritem in/ali srbenje, krvavitve, bolečine ali oteklost) imelo 12,9 % bolnikov, ki so dobivali adalimumab, in 7,2 % bolnikov, ki so dobivali placebo ali kontrolno učinkovino.
Most patients continued on adalimumab after the infection resolved.
Večina bolnikov je po ozdravitvi okuţbe nadaljevala zdravljenje z adalimumabom.
Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table
Rezultati po 12. tednu so pokazali statistično pomembno izboljšanje znakov in simptomov aktivnega nr-axSpA pri bolnikih, ki so bili zdravljeni z adalimumabom v primerjavi s placebom (preglednica 14).
- If you have any further questions, please ask your doctor or pharmacist.
- Če imate dodatna vprašanja, se prosimo posvetujte z zdravnikom ali farmacevtom.
Thirty-three (18%) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 146 (79%) patients with NSAIDs at baseline.
33 (18 %) bolnikov je bilo na začetku sočasno zdravljenih z modifikatorji bolezni ali protirevmatskimi zdravili in 146 (79 %) bolnikov z nesteroidnimi antirevmatiki.
• Hold the syringe firmly without moving it, at the same angle (Figure R).
• Injekcijsko brizgo drţite trdno, ne da bi jo pri tem premikali ali spreminjali kot vboda (Slika R).
Put it on a clean flat surface.
Poloţite ga na čisto, ravno površino.
Warning: Call your healthcare professional if you did not inject the full dose.
Opozorilo: Če niste injicirali celotnega odmerka, pokličite svojega zdravstvenega delavca.
6.4 Remove the needle from the skin, being careful to pull it out at the same angle that it was inserted.
6.4 Injekcijsko iglo izvlecite iz koţe pod istim kotom, kot ste jo vstavili.
In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6% and 55.7%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Opravljena je bila analiza, v kateri so vse bolnike, ki so izpadli iz študije zaradi neţelenih učinkov ali nezadostne učinkovitosti, ali jim je bil povečan odmerek, obravnavali kot neodzivne; pri teh bolnikih sta bila po dodatnih 108 tednih odprtega zdravljenja (skupaj 160 tednov) deleţ odziva PASI 75 69,6 % in deleţ odziva PGA "čisto" ali "minimalno" 55,7 %.
There is insufficient evidence of the efficacy of Kromeya in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.
Zaradi majhnega števila bolnikov ni dovolj dokazov o učinkovitosti zdravila Kromeya pri bolnikih s psoriatično artropatijo, podobno ankilozirajočemu spondilitisu.
Administration of Kromeya 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 okuţba ali sepsa, je treba uporabo zdravila Kromeya prekiniti in uvesti ustrezno protimikrobno ali protimikotično zdravljenje, dokler okuţba ni obvladana.
• In addition cases of non-melanoma skin cancer have been observed in patients taking adalimumab.
• Poleg tega so pri bolnikih, zdravljenih z adalimumabom, opazili primere nemelanomskega koţnega raka.
There is no apparent correlation between the presence of anti-adalimumab antibodies and the occurrence of adverse events.
Med prisotnostjo protiteles proti adalimumabu in pojavnostjo neţelenih učinkov ni očitne korelacije.
If you accidentally inject a larger amount of Kromeya liquid, or if you inject Kromeya more frequently than told to by your doctor, call your doctor and tell him/her that your child has taken more.
Če pomotoma injicirate večjo količino zdravila Kromeya tekočine ali če injicirate zdravilo Kromeya pogosteje, kot vam je naročil zdravnik, se morate posvetovati z njim in mu povedati, da je vaš otrok uporabil večji odmerek.
Week 52 Fistula remission3
52. teden Remisija fistule
4.4 Pull back the pink needle safety cover toward the syringe.
4.4 Potegnite roza varovalo za injekcijsko iglo proti injekcijski brizgi.
Infection
Okužbe
• Do not try to activate the clear needle guard before injecting.
• Prozornega varovala za injekcijsko iglo ne poskušajte aktivirati pred injiciranjem.
Patients receiving MTX who achieved a ≥ PASI 50 response at week 8 and/or 12 did not receive further dose increases.
Bolnikom, ki so dobivali metotreksat in so 8. in/ali 12. teden dosegli odziv PASI ≥ 50, odmerka niso več povečevali.
This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test).
To bo vključevalo natančno zdravniško oceno vključno s poizvedbo o vašem zdravju v preteklosti in preiskave (npr. rentgensko slikanje prsnih organov in tuberkulinski test).
Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity and genotoxicity.
Predklinični podatki na osnovi študij toksičnosti posameznih odmerkov, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kaţejo posebnega tveganja za človeka.
It is important to tell your doctor if your child has had or has a serious heart condition (see “Warnings and precautions”).
Pomembno je, da zdravniku poveste, če je vaš otrok imel ali ima kakšno resno bolezen srca (glejte "Opozorila in previdnostni ukrepi").
PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50% were taking methotrexate.
V njej so zdravili 313 odraslih, ki se niso ustrezno odzvali na terapijo z nesteroidnimi protivnetnimi zdravili; pribliţno 50 % od teh je jemalo metotreksat.
In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
V kontroliranih in odprtih študijah pri odraslih in otrocih z adalimumabom so poročali o resnih okuţbah (vključno s smrtno nevarnimi okuţbami, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in invazivne oportunistične okuţbe (npr. diseminirana ali zunajpljučna histoplazmoza, blastomikoza, kokcidioidomikoza, pnevmocistoza, kandidaza, aspergiloza in listerioza).
• non-infectious uveitis
• neinfekcijski uveitis.
Study UV I evaluated 217 patients with active uveitis despite treatment with corticosteroids (oral prednisone at a dose of 10 to 60 mg/day).
Študija UV I je ovrednotila 217 bolnikov z aktivnim uveitisom kljub zdravljenju s kortikosteroidi (prednizon peroralno v odmerku 10 do 60 mg/dan).
5.4 Hold the syringe like a pencil with the pink needle safety cover pointing up
5.4 Injekcijsko iglo drţite kot svinčnik, pri čemer je roza varovalo za injekcijsko iglo obrnjeno navzgor.
1.6 Place the remaining pre-filled pen(s) in its (their) original box back in the refrigerator (Figure E).
1.6 Drug injekcijski peresnik (druge injekcijske peresnike) poloţite nazaj v hladilnik v originalni ovojnini (Slika E).
Amongst those who responded at week 16 (n=144), the Pediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Med bolniki, ki so se odzvali 16. teden (n = 144), so se odzivi »Pediatric ACR« 30/50/70/90 v odprti podaljšani fazi ohranili do šest let pri tistih, ki so ves čas študije dobivali adalimumab.
The recommended doses for Kromeya in each of the approved uses are shown in the following table.
Priporočen odmerek zdravila Kromeya je enak odobreni uporabi, kot je prikazano v spodnji preglednici.
Table 19 Ps Study IV efficacy results at 16, 26 and 52 weeks
Preglednica 19: Študija pri psoriazi IV Rezultati učinkovitosti po 16, 26 in 52 tednih
Kromeya may have a minor influence on the ability to drive, cycle or use machines.
Zdravilo Kromeya ima lahko blag vpliv na sposobnost voţnje, kolesarjenja ali upravljanja strojev.
• The name on the syringe says Kromeya (Figure K).
• je na injekcijski brizgi ime Kromeya (Slika K).
Figure 1: Kaplan-Meier curves summarizing time to flare in study nr-axSpA II
Slika 1: Kaplan-Meier-jeve krivulje povzemajo čas do ponovnega zagona bolezni v študiji nr-axSpA II
Table 16 Ps study IV efficacy results at 16, 26 and 52 weeks
Preglednica 16: Študija pri psoriazi IV Rezultati učinkovitosti po 16, 26 in 52 tednih
Step 4 Choose the injection Site
4. korak Izberite mesto injiciranja
After Injection
Po injiciranju
Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia pruritus
pogosti poslabšanje ali pojav psoriaze (vključno s palmplantarno pustularno psoriazo) urtikarija, modrice (vključno s purpuro), dermatitis (vključno z ekcemom), oniholiza, čezmerno znojenje,
Kromeya 40 mg/0.8 mL solution for injection for paediatric use in single-use vial 0.8 mL solution in vial (type I glass) with a rubber stopper (synthetic rubber) and aluminium crimp seal.
Kromeya 40 mg /0,8 ml raztopina za injiciranje za pediatrično uporabo v enoodmerni viali 0,8 ml raztopine v viali (steklo tipa I), z gumijastim zamaškom (sintetična guma) in obrobno zaporko iz aluminija.
Statistically and clinically significant improvements from Baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Opazili so tudi statistično in klinično pomembno izboljšanje parametrov kvalitete ţivljenja (vključno z IMPACT III) glede na začetek študije.
If you stop using Kromeya
Če ste prenehali uporabljati zdravilo Kromeya
Table 11 Distribution of patients by age and adalimumab dose received during the OL LI phase
Preglednica 11 Porazdelitev bolnikov po starosti in odmerku adalimumaba, ki so ga dobivali med odprto uvajalno fazo
Your child may first be given other disease-modifying medicines, such as methotrexate.
Morda bo vaš otrok najprej dobil druga imunomodulirajoča zdravila, npr. metotreksat.
The Kromeya pre-filled syringe is supplied in a glass syringe with needleguard and finger flanges.
Napolnjena injekcijska brizga Kromeya je steklena brizga s ščitnikom za iglo in prirobnico za prste.
• Upright and stable during use,
• stoji pokonci in se med uporabo ne prevrača,
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Psoriatični artritis je vnetna bolezen sklepov, povezana s koţno luskavico.
Kromeya 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.
Zdravilo Kromeya je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 µg/mL for patients ≥ 40 kg (160/80 mg) and 10.6±6.1 µg/mL for patients < 40 kg (80/40 mg).
Povprečne (±SD) serumske koncentracije adalimumaba, doseţene v 4. tednu, so bile 15,7 ± 6,6 μg/ml pri bolnikih ≥ 40 kg (160/80 mg) in 10,6 ± 6.1 μg/ml pri bolnikih < 40 kg (80/40 mg).
• Do not use the Kromeya pre-filled syringe if liquid appears cloudy or discolored, or has -particles or flakes in it.
• Zdravilo Kromeya napolnjeno injekcijsko brizgo ne uporabljajte, če je tekočina motna ali obarvana ali če so v njej delci ali kosmiči.
Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in adalimumab-treated patients through week 156 and week 104, respectively.
Statistično izboljšanje znakov vnetja, merjenih s C-reaktivnim proteinom z veliko občutljivostjo (hsCRP) in z magnetno resonanco (MRI) sakroiliakalnih sklepov in hrbtenice, se je ohranilo pri bolnikih, zdravljenih z adalimumabom, do 156. tedna oz. do 104. tedna, v tem zaporedju.
Kromeya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Zdravilo Kromeya je indicirano za zdravljenje neinfekcijskega intermediarnega, posteriornega uveitisa in panuveitisa pri odraslih bolnikih, ki se niso zadostno odzvali na zdravljenje s kortikosteroidi, pri bolnikih s potrebo po zmanjšani uporabi kortikosteroidov ali pri bolnikih, pri katerih je zdravljenje s kortikosteroidi neprimerno.
• signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
• znake ali simptome okuţbe, npr. zvišano telesno temperaturo, splošno slabo počutje, rane, teţave z zobmi, pekoč občutek med uriniranjem; občutek šibkosti ali utrujenosti; ali kašelj;
If you have mild heart failure and you are being treated with Kromeya, your heart failure status must be closely monitored by your doctor.
Če imate blago srčno popuščanje in se zdravite z zdravilom Kromeya, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
For patients who dose escalated from eow to weekly regimen, the mean (±SD) serum concentrations of adalimumab at week 52 were 15.3±11.4 μg/mL (40/20 mg, weekly) and 6.7±3.5 μg/mL (20/10 mg, weekly).
Pri bolnikih, ki so prešli iz reţima vsak drugi teden na reţim vsak teden, so bile povprečne (±SD) serumske koncentracije adalimumaba v 52. tednu 15,3 ± 11,4 μg/ml (40/20 mg, tedensko) in 6,7 ± 3,5 μg/ml (20/10 mg, tedensko).
Each pack contains 2 or 6 pre-filled pens with 2 or 6 alcohol pads.
Vsako pakiranje vsebuje 2 ali 6 napolnjenih injekcijskih peresnikov z 2 ali 6 alkoholnimi zloţenci.