natgillin/translations-raw huggingface dataset:
Some patients who experience decrease in their response to Kromeya 40 mg every other week may benefit from an increase in dosage to 40 mg Kromeya every week or 80 mg every other week.
Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Kromeya 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila Kromeya na 40 mg vsak teden ali na 80 mg vsak drugi teden.
• enthesitis-related arthritis,
• artritis, povezan z entezitisom,
Once removed from the refrigerator for room temperature storage, your vial must be used within 14 days or discarded, even if it is later returned to the refrigerator.
Ko napolnjeno injekcijsko brizgo enkrat, namesto v hladilniku, shranjujete pri sobni temperaturi, morate brizgo porabiti v 14 dneh ali pa zavreči, tudi če jo kasneje vrnete v hladilnik.
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Pri bolnikih, zdravljenih z adalimumabom, je bil v redkih primerih med obdobjem trţenja identificiran hepatosplenični limfom celic T. Ta redka oblika limfoma celic T ima zelo agresiven potek bolezni in je običajno smrtna.
Initial dose of 20 mg, followed by 20 mg one week later.
Začetni odmerek 20 mg, ki mu sledi 20 mg en teden kasneje.
Figure K Warning: Do not use the syringe if:
Opozorilo: Injekcijske brizge ne uporabljajte, če:
In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, 26.4% (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
V odprti podaljšani študiji je odziv PASI 75 v 12. tednu oziroma 24. tednu doseglo 92 od 349 (26,4 %) bolnikov oziroma 132 od 349 (37,8 %) bolnikov, katerim so zaradi odziva PASI pod 50 % odmerek povečali s 40 mg vsak drugi teden na 40 mg vsak teden.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Podatki, ki so na voljo, kaţejo, da je klinični odziv ponavadi doseţen v 12 tednih zdravljenja.
Figure 1: Kaplan-Meier curves summarizing time to treatment failure in the paediatric uveitis study
Slika 1: Kaplan-Meierjeve krivulje povzemajo čas do neuspeha zdravljenja v študiji uveitisa pri pediatričnih bolnikih
Adalimumab was assessed in a multicenter, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Adalimumab je bil ocenjen v multicentrični, randomizirani, dvojno slepi klinični študiji, ki je bila zasnovana za oceno učinkovitosti in varnosti uvodnega in vzdrţevalnega zdravljenja z odmerki, odvisnimi od telesne mase (< 40 mg ali ≥ 40 mg) pri 192 pediatričnih bolnikih med 6. in 17.
* p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a
* p < 0,001 za parne primerjave deleţev med adalimumabom in placebom ** p < 0,02 za parne primerjave deleţev med adalimumabom in placebom a
Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
Zato je treba pri bolnikih s KOPB in bolnikih, ki jih zaradi hudega kajenja bolj ogroţa malignom, vsak antagonist TNF uporabljati previdno.
Kromeya is also used to treat severe plaque psoriasis in children and adolescents adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Zdravilo Kromeya se uporablja tudi za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih zdravila, ki se nanašajo na koţo in zdravljenje z UV svetlobo, nista dovolj dobro delovala ali pa nista primerna.
(up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/mL with concomitant methotrexate.
(do največ 40 mg) subkutano vsak drugi teden bolnikom z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednost merjena v 24. tednu) 8,8 ± 6,6 μg/ml med uporabo adalimumaba brez metotreksata in 11,8 ± 4,3 μg/ml med sočasno uporabo metotreksata.
Storage Information
Navodila za shranjevanje
Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.
Pri teh bolnikih je pri postavitvi diagnoze in izbiri empiričnega antimikotičnega zdravljena potreben posvet z zdravnikom, izkušenim v zdravljenju bolnikov z invazivnimi glivičnimi okuţbami.
• mouth infections (including tooth infections and cold sores);
• okuţbe ust (vključno z okuţbami zob in herpesom);
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see Table 10).
V študiji revmatoidnega artritisa V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija z adalimumabom in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive po ACR kot monoterapija z metotreksatom ali monoterapija z adalimumabom, odzivi pa so se ohranili do 104. tedna (glejte preglednico 10).
It is important that you tell your doctor if your child has symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
Pomembno je, da zdravniku poveste, če ima vaš otrok simptome okuţb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali teţave z zobmi (glejte "Opozorila in previdnostni ukrepi").
5.2 Clean the injection site with an alcohol pad and throw the pad away.
5.2 Koţo na mestu injiciranja obrišite z zloţencem, prepojenim z alkoholom, in ga zavrzite.
In monotherapy, some patients who experience a decrease in their response to Kromeya 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Med monoterapijo lahko nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Kromeya 40 mg vsak drugi teden, koristi povečanje odmerka adalimumaba na 40 mg vsak teden ali na 80 mg vsak drugi teden.
3.3 Turn the vial upside down so it is vertical with the syringe still attached.
3.3 Vialo obrnite na glavo, tako da gleda navzdol skupaj s pritrjeno injekcijsko brizgo.
What Kromeya contains
Kaj vsebuje zdravilo Kromeya
• Push and hold the pre-filled pen firmly against your skin until the safety guard is fully depressed.
• Napolnjen injekcijski peresnik močno pritisnite na koţo in ga drţite, da se varovalo popolnoma spusti.
Adalimumab treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at week 24.
Ob zdravljenju z adalimumabom so v primerjavi s placebom 24. teden ugotovili statistično značilno izboljšanje telesnega delovanja, ocenjeno z vprašalnikoma HAQ in SF 36 (Short Form Health Survey).
The recommended dose of Kromeya for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1).
Priporočeni odmerek zdravila Kromeya pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih 2 leti in več, temelji na telesni masi (preglednica 1).
3.7 Place the syringe on a clean, flat surface.
3.7 Injekcijsko brizgo poloţite na čisto, ravno površino.
You are advised to avoid becoming pregnant and must use adequate contraception while using Kromeya and for at least 5 months after the last Kromeya injection.
Svetujemo vam, da preprečite nosečnost in uporabljate ustrezno kontracepcijsko zaščito, dokler uporabljate zdravilo Kromeya in še 5 mesecev po zadnjem injiciranju zdravila Kromeya.
ACR 20 Week 52 62.6% 54.4% 72.8% Week 104 56.0% 49.3% 69.4% ACR 50 Week 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 Week 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 ACR 70 Week 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 Week 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864 a. p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
52. teden 45,9 % 41,2 % 61,6 % < 0,001 < 0,001 0,317 104. teden 42,8 % 36,9 % 59,0 % < 0,001 < 0,001 0,162 ACR 70
It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
Pomembno je, da zdravniku poveste, če imate simptome okuţb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali teţave z zobmi (glejte "Opozorila in previdnostni ukrepi").
2.2 Check the label on the vial for Kromeya and expiration date.
Preglejte nalepko in preverite, ali je na njej ime Kromeya in če je rok uporabnosti ţe pretekel.
Initial dose of 20 mg, followed by 20 mg given every other week starting one week after the initial dose
Začetni odmerek 20 mg, ki mu sledi odmerek 20 mg vsak drugi teden, z začetkom en teden po začetnem odmerku
• If needed, for example when traveling, the Kromeya Vial Kit can be stored at room temperature for up to 14 days.
• Po potrebi lahko zdravilo Kromeya komplet z vialo shranjujete pri sobni temperaturi do 14 dni,
You should record the date when the pen is first removed from refrigerator, and the date after which it should be discarded.
Zapisati si morate datum, ko je bil peresnik vzet iz hladilnika in datum, po katerem ga je potrebno zavreči.
For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Kromeya should be promptly discontinued.
Če se bolniku pojavijo znaki ali simptomi, kot so npr. zvišana telesna temperatura, splošno slabo počutje, hujšanje, znojenje, kašelj, dispneja in/ali pljučni infiltrati ali druga resna sistemska bolezen (s spremljajočim šokom ali brez njega), je treba posumiti na invazivno glivično okuţbo.
• systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung,
• sistemski eritematozni lupus (imunske motnje vključno z vnetjem koţe, srca, pljuč, sklepov in drugih organskih sistemov);
Adalimumab 40 mg eow N=814 n (%)
Adalimumab 40 mg vsak 2. teden n = 814 n (%)
If you receive Kromeya during your pregnancy, your baby may have a higher risk for getting an infection.
Če prejemate zdravilo Kromeya med nosečnostjo, obstaja večje tveganje, da bo vaš dojenček dobil okuţbo.
A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease and ulcerative colitis after treatment with adalimumab.
Pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, Crohnovo boleznijo in ulceroznim kolitisom so opazili tudi naglo zniţanje koncentracij CRP po zdravljenju z adalimumabom.
• The needle cap is securely attached (Figure H).
• je pokrovček na injekcijski igli trdno pritrjen (Slika H).
Record injection and dispose components
Zabeleţite injiciranje in zavrzite pripomočke
Table 9 ACR responses in placebo-controlled trials (percent of patients)
Preglednica 9: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov)
Warning: Do not try to put the needle cap back on the needle.
Opozorilo: Pokrovčka ne poskušajte ponovno namestiti na injekcijsko iglo.
Table 7 ACR responses in placebo-controlled trials (percent of patients)
Preglednica 7: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov)
Kromeya is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Zdravilo Kromeya je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri odraslih bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
Warning: Do not blow on or touch the injection site after cleaning.
Opozorilo: Na očiščeno mesto injiciranja ne pihajte ali se ga dotikajte.
• pull the syringe straight up and out of the packaging (Figure C).
• injekcijsko brizgo potegnite navzgor iz škatle (Slika C).
One 0.8 mL vial contains 40 mg adalimumab
Ena 0,8 ml viala vsebuje 40 mg adalimumaba.
Ulcerative colitis Age or body weight
Ulcerozni kolitis Starost ali telesna masa
Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Podatki, ki so na voljo, kaţejo, da je klinični odziv po navadi doseţen v 12 tednih zdravljenja.
Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Med 68 bolniki iz skupine namenjene prenehanju zdravljenja, pri katerih je prišlo do ponovnega zagona bolezni, jih je 65 zaključilo 12 tednov trajajoče rešilno zdravljenje z adalimumabom, od tega
Figure Q Warning: Call your healthcare professional or pharmacist if you have any problem.
Opozorilo: V primeru teţav pokličite vašega zdravstvenega delavca ali farmacevta.
Sustained remission
Ohranjena remisija
Kromeya is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Zdravilo Kromeya se uporablja za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih zdravila, ki se nanašajo na koţo in zdravljenje z UV svetlobo nista dovolj dobro delovala ali pa nista primerna.
• erythema multiforme (inflammatory skin rash);
• multiformni eritem (vnetje koţnega izpuščaja);
Myocardial infarction arrhythmia, congestive heart failure
pogosti tahikardija občasni miokardni infarkt aritmija, kongestivno srčno popuščanje
Do not shake the syringe.
Brizge ne stresajte.
Your healthcare provider should show you how to prepare and inject Kromeya properly using the vial kit before you use it for the first time.
Vaš zdravstveni delavec vam mora pokazati kako pravilno pripraviti in injicirati zdravilo Kromeya preden boste komplet z vialo prvič uporabili.
• a sharps disposal container.
• zbiralnik za ostre predmete.
Kromeya is used to treat psoriatic arthritis in adults.
Zdravilo Kromeya se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
Erythema multiforme Stevens-Johnson syndrome angioedema cutaneous vasculitis lichenoid skin reaction
alopecija srbenje občasni nočno potenje, brazgotinjenje redki multiformni eritem sindrom Stevens-Johnson, angioedem koţni vaskulitis lihenoidna reakcija neznana pogostnost poslabšanje simptomov dermatomiozitisa
Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Kromeya.
Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem z zdravilom Kromeya ali po njem doţivijo znake/simptome, ki nakazujejo tuberkulozno okuţbo (npr. trdovraten kašelj, hujšanje/izgubljanje teţe, nekoliko zvišano telesno temperaturo, ravnodušnost).
Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration
Presnovne in prehranske motnje zelo pogosti zvišanje lipidov pogosti hipokalemija, hiperurikemija, nenormalni nivo natrija v krvi, hipokalcemija, hiperglikemija, hipofosfotemija, dehidracija
Your healthcare provider should show you how to prepare and inject Kromeya properly using the pre-filled syringe before you use it for the first time.
Vaš zdravstveni delavec vam mora pokazati kako pravilno pripraviti in injicirati zdravilo Kromeya preden boste napolnjeno injekcijsko brizgo prvič uporabili.
Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide and water for injections.
Pomoţne snovi: natrijev dihidrogenfosfat dihidrat, dinatrijev fosfat dihidrat, manitol, natrijev klorid, monohidrat citronske kisline, natrijev citrat, polisorbat 80, natrijev hidroksid in voda za injekcije.
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 vzeta iz hladilnika in datum, po katerem jo je potrebno zavreči.
Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg/mL (without concomitant methotrexate) and 8 to 9 µg/mL (with concomitant methotrexate), respectively.
Po subkutani uporabi 40 mg zdravila adalimumab vsak drugi teden pri odraslih bolnikih z revmatoidnim artritisom (RA) so bile povprečne najmanjše koncentracije v stanju dinamičnega ravnovesja pribliţno 5 μg/ml (brez sočasne uporabe metotreksata) in od 8 do 9 μg/ml (s sočasno uporabo metotreksata).
In CD study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
V študiji Crohnove bolezni I je bilo 299 bolnikov, ki še niso prejemali TNF-antagonistov, randomiziranih v eno od štirih skupin; placebo v 0. in 2. tednu, 160 mg adalimumaba v 0. tednu in 80 mg v 2. tednu, 80 mg v 0. tednu in 40 mg v 2. tednu in 40 mg v 0. tednu in 20 mg v 2. tednu.
Ped ACR 30 response (n/N)
Faza Odprta uvajalna faza 16 tednov Odziv »Ped ACR« 30 (n/N)
• The expiration date on syringe has not passed (Figure K).
• ali se je rok uporabnosti iztekel (Slika K).
It is recommended that the conduct and results of these tests are recorded in the patient reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Zdravniki se morajo zavedati tveganja za laţno negativne izvide tuberkulinskega koţnega testa, zlasti pri hudo bolnih ali imunsko oslabelih bolnikih.
Kromeya 40 mg solution for injection in pre-filled syringe Kromeya 40 mg solution for injection in pre-filled pen
Kromeya 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Kromeya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
• Do not use an Kromeya pre-filled pen that has been frozen or left in direct sunlight.
• Zdravila Kromeya napolnjen injekcijski peresnik ne uporabljajte, če je bil injekcijski peresnik zamrznjen ali dlje časa izpostavljen neposredni sončni svetlobi.
In adult patients with psoriasis, the mean steady-state trough concentration was 5 µg/mL during adalimumab 40 mg every other week monotherapy treatment.
Pri odraslih bolnikih s psoriazo je bila povprečna koncentracija v stanju dinamičnega ravnovesja med monoterapijo z adalimumabom 40 mg vsak drugi teden 5 μg/ml.
• polyarticular juvenile idiopathic arthritis,
• poliartikularni juvenilni idiopatski artritis,
Kromeya is injected under the skin (subcutaneous use).
Zdravilo Kromeya se injicira pod koţo (subkutana uporaba).
• The name on the pre-filled pen says Kromeya (Figure I).
• je na injekcijskem peresu ime Kromeya (Slika I).
Kromeya is used to treat ulcerative colitis in adults.
Zdravilo Kromeya se uporablja za zdravljenje ulceroznega kolitisa pri odraslih.
Pancreatitis, dysphagia, face oedema
• hud izpuščaj, koprivnico
Keep the pre-filled syringe or pre-filled pen in its outer carton in order to protect from light.
Napolnjeno injekcijsko brizgo ali napolnjen injekcijski peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
The recommended Kromeya dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Priporočeni odmerek zdravila Kromeya pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
Double blind 32 weeks Adalimumab
Rezultati učinkovitosti Dvojno slepa 32 tednov Adalimumab / MTX (N = 38)
Front view
Sprednja stran
In the open-label extension of RA study V, the mean change from baseline at Year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomised to methotrexate monotherapy, adalimumab monotherapy and adalimumab/methotrexate combination therapy, respectively.
V odprtem podaljšanju študije revmatoidnega artritisa V je bila povprečna sprememba celotne Sharpove ocene v 10. letu pri bolnikih, ki so jih na začetku randomizirali na monoterapijo z metotreksatom, monoterapijo z adalimumabom in kombinacijo adalimumaba/metotreksat, glede na izhodišče 10,8, 9,2 oz. 3,9.
Table 9 Radiographic mean changes over 12 months in RA study III
Preglednica 9: Povprečne rentgenografske spremembe v 12 mesecih študije revmatoidnega artritisa III
Table 8 ACR responses in RA study V (percent of patients)
Preglednica 8: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
Muscle spasms (including blood creatine phosphokinase increased)
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti mišičnoskeletne bolečine pogosti mišični spazmi (vključno s povišano kreatin fosfokinazo v krvi)
Your child is advised to avoid becoming pregnant and must use adequate contraception while using Kromeya and for at least 5 months after the last Kromeya injection.
Za vašega otroka je priporočljivo, da ne zanosi in uporablja ustrezno kontracepcijsko zaščito, dokler uporablja zdravilo Kromeya in še 5 mesecev po zadnjem injiciranju zdravila Kromeya.
3.6 Turn over the vial and syringe, firmly hold the vial adapter and unscrew the syringe from the vial adapter.
3.6 Vialo in injekcijsko brizgo obrnite, trdno primite nastavek za vialo in injekcijsko brizgo odvijte iz nastavka.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobnejše informacije o tem zdravilu so na voljo na spletni strani Evropske Agencije za zdravila http://www.ema.europa.eu.
7.1 Throw away your used syringe in a sharps disposal container right away after use (Figure U).
7.1 Uporabljeno injekcijsko brizgo takoj zavrzite v zbiralnik za ostre predmete (Slika U).
• inflammation of the skin (such as eczema);
• vnetje koţe (kot je ekcem);
The double-blind period is followed by an openlabel (OL) period during which patients received 24 mg/m2 BSA of adalimumab up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Obdobju dvojno slepega preskušanja je sledilo obdobje odprtega preskušanja, v katerem so bolniki prejemali 24 mg/m telesne površine adalimumaba do največjega posamičnega odmerka 40 mg vsak drugi teden subkutano do največ 192 tednov.