natgillin/translations-raw huggingface dataset:
Be sure that you read, understand, and follow these Instructions for Use before injecting Kromeya.
Pred injiciranjem zdravila Kromeya, bodite prepričani, da ste prebrali, razumeli in sledili tem Navodilom za uporabo.
Kromeya is recommended for use in combination with methotrexate.
Priporoča se kombinirana uporaba zdravila Kromeya z metotreksatom.
In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of adalimumab-treated patients and 0.6% of control-treated patients.
V kontroliranih preskušanjih z adalimumabom (v začetnem odmerku 160 mg v tednu 0, ki mu sledi odmerek 80 mg v 2. tednu in potem 40 mg vsak teden z začetkom v 4. tednu) pri bolnikih s hidradenitis suppurativa in s trajanjem kontrolnega obdobja od 12 do 16 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 0,3 % bolnikov, zdravljenih z adalimumabom, in pri 0,6 % bolnikov v kontrolni skupini.
Adult Crohn's disease
Crohnova bolezen pri odraslih
There is no relevant use of Kromeya in children aged less than 2 years in this indication.
Uporaba zdravila Kromeya pri otrocih, mlajših od 2 let, za to indikacijo ni primerna.
Initial dose of 40 mg, followed by 40 mg one week later.
Začetni odmerek 40 mg, ki mu sledi 40 mg en teden kasneje.
Kromeya is used to treat rheumatoid arthritis in adults.
Zdravilo Kromeya se uporablja za zdravljenje revmatoidnega artritisa pri odraslih.
• rheumatoid arthritis,
• revmatoidni artritis,
• If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Kromeya.
• Če imate ali pa se pri vas razvija demielinizirajoča bolezen (bolezen, ki vpliva na izolacijsko plast okoli ţivcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko dobivate oziroma tudi še nadalje dobivate zdravilo Kromeya.
• Tell your doctor if your child has lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
• Zdravniku morate povedati, če je vaš otrok ţivel ali je potoval v predele, kjer so pogoste glivične okuţbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
Adalimumab has not been studied in these patient populations.
Adalimumab pri teh populacijah bolnikov še ni bil preskušen, zato priporočil za odmerjanje ni mogoče dati.
Initial dose of 40 mg, followed by 20 mg two weeks later.
Začetni odmerek je 40 mg, ki mu sledi 20 mg dva tedna kasneje.
The rate (95% confidence interval) of nonmelanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Deleţ (95 % interval zaupanja) nemelanomskih koţnih rakov je bil 8,8 (6,0; 13,0) na 1000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 3,2 (1,3; 7,6) na 1000 bolnikov-let med kontrolnimi bolniki.
- Your doctor will also give you a patient reminder card, which contains important safety information that you need to be aware of before you are given Kromeya and during treatment with Kromeya.
Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete zdravilo Kromeya in med zdravljenjem z njim.
Always use this medicine exactly as your child's doctor or pharmacist has instructed.
Pri uporabi tega zdravila natančno upoštevajte navodila otrokovega zdravnika ali farmacevta .
Warning: Do not warm the syringe any other way, such as in a microwave, hot water, or direct sunlight.
Opozorilo: Injekcijske brizge ne smete ogreti na noben drug način, na primer v mikrovalovni pečici, vroči vodi ali na neposredni sončni svetlobi.
Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to week 12, with a maximum dose of 25 mg or an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
Bolniki so dobivali placebo, začetni odmerek 7,5 mg metotreksata z nadaljnjim povečanjem odmerka do 12. tedna; do največjega odmerka 25 mg, ali začetni odmerek 80 mg adalimumaba in potem 40 mg vsak drugi teden (začenši en teden po začetnem odmerku) 16 tednov.
In CD study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
V študiji Crohnove bolezni II je bilo 325 bolnikov, ki so postali neodzivni ali so imeli intoleranco na infliksimab, randomiziranih, da so prejeli ali 160 mg adalimumaba v 0. tednu in 80 mg v 2. tednu ali placebo v 0. in 2. tednu.
• Store the Kromeya Vial Kit in its original box to protect it from light.
• Zdravilo Kromeya komplet z vialo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
The recommended Kromeya induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Priporočena shema odmerjanja zdravila Kromeya med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivnim ulceroznim kolitisom 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
Warning: Keep your sharps disposal container out of the reach of children.
Opozorilo: Zbiralnik za ostre predmete shranjujte nedosegljiv otrokom.
Adalimumab was evaluated in over 3000 patients in all rheumatoid arthritis clinical trials.
V vseh kliničnih preskušanjih revmatoidnega artritisa (RA) so adalimumab ocenili pri več kot 3000 bolnikih.
The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised double-blind study (Psoriasis study III).
Varnost in učinkovitost adalimumaba so raziskali tudi v randomizirani dvojno slepi študiji pri odraslih bolnikih z zmerno do hudo kronično psoriazo v plakih s sočasno psoriazo na dlaneh in/ali stopalih, ki so bili kandidati za sistemsko zdravljenje (Študija pri psoriazi III).
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Če se med zdravljenjem ali po njem pojavijo simptomi tuberkuloze (trdovraten kašelj, hujšanje, brezvoljnost, rahlo zvišana telesna temperatura) ali kakšne druge okuţbe, to takoj povejte zdravniku.
• The needle guard spring is not extended (Figure I).
• vzmet varovala za injekcijsko iglo ni raztegnjena (Slika I).
Analysis treatment
Analiza
Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
d povprečna sprememba od začetka zdravljenja e n = 91 placebo in n = 87 adalimumab f hs-CRP = C-reaktivni protein z veliko občutljivostjo (high sensitivity C-Reactive Protein) (mg/L)
Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
zelo pogosti okuţbe respiratornega trakta (vključno z okuţbo spodnjega in zgornjega respiratornega trakta, pljučnico, vnetjem sinusa, vnetjem sluznice ţrela, vnetjem nosnega dela ţrela in pljučnim virusnim herpesom)
3.2 Hold the vial adapter, insert the syringe tip into it and screw to connect.
3.2 Primite nastavek za vialo, vanj vstavite konico injekcijske brizge in jo privijte, da se pritrdi.
• vertigo (sensation of room spinning);
• vrtoglavica (občutek vrtenja v prostoru);
If your child received Kromeya during her pregnancy, her baby may have a higher risk for getting an infection.
Če je vaš otrok prejemal zdravilo Kromeya med nosečnostjo, obstaja večje tveganje, da bo njegov dojenček dobil okuţbo.
If a faster response is required, your child's doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg two weeks later.
Če je potreben hitrejši odziv, lahko zdravnik vašega otroka predpiše začetni odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
2.6 Peel off the paper from the vial adapter packaging without taking the vial adaptor out of its packaging.
2.6 Z ovojnine nastavka za vialo odstranite papir, ne da bi nastavek vzeli iz ovojnine.
Warning: Do not rub the injection site.
Opozorilo: Mesta injiciranja ne drgnite.
In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of adalimumab-treated patients and 1.3% of control-treated patients.
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih z juvenilnim idiopatskim artritisom, ki so bili stari od 4 do 17 let in bolnikih z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, so se zvišanja ALT ≥ 3 x ULN pojavila pri 6,1 % bolnikov zdravljenih z adalimumabom, in pri 1,3 % bolnikov v kontrolni skupini.
You should record the date when the vial is first removed from refrigerator, and the date after which it should be discarded.
Zapisati si morate datum, ko je bila viala vzeta iz hladilnika in datum, po katerem jo je potrebno zavreči.
Single use pre-filled syringe (adalimumab) for subcutaneous injection 40mg
Napolnjen injekcijski peresnik (adalimumab) za subkutano injiciranje 40 mg
Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.
Obvestite svojega zdravnika, če se pojavijo simptomi, kot so vztrajen nepojasnjen izpuščaj, zvišana telesna temperatura, bolečine v sklepih ali utrujenost.
Warning: Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have stretch marks.
Opozorilo: Zdravila ne smete injicirati v predel, ki je boleč (občutljiv), podplut, pordel, otrdel ali ki ima brazgotine ali strije.
Clinical response (CR-100) Patients in steroid-free remission for >=90 days a
Klinična remisija Klinični odziv (CR-100) Bolniki v remisiji brez steroidov 5 % (3/66) za ≥ 90 dni a
• Store the Kromeya Vial Kit in a refrigerator between 2°C to 8°C.
• Zdravilo Kromeya komplet z vialo shranjujte v hladilniku pri temperaturi med 2 °C in 8 °C.
Among those, 64 patients (79.0%) had ACR 20 responses; 56 patients (69.1%) had ACR 50 responses; and 43 patients (53.1%) had ACR 70 responses.
Med temi je 64 bolnikov (79,0 %) imelo odziv 20 po ACR; 56 bolnikov (69,1 %) je imelo odziv 50 po ACR; in 43 bolnikov (53,1 %) je imelo odziv 70 po ACR.
• If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Kromeya.
• Če imate kakšno okuţbo, vključno z dolgotrajno ali omejeno okuţbo (npr. razjedo na nogi), se pred uporabo zdravila Kromeya posvetujte s svojim zdravnikom.
Do not use this medicine after the expiry date which is stated on the label/ carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/škatli poleg oznake “EXP”.
At week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 23.
V 4. tednu so bili bolniki glede na njihovo telesno maso v tem času randomizirani v razmerju 1:1 bodisi v vzdrţevalni reţim z majhnim odmerkom ali vzdrţevalni reţim s standardnim odmerkom, kot kaţe preglednica 23.
Table 12 Ped ACR 30 responses in the JIA study
Preglednica 12 Odzivi »Ped ACR« 30 v študiji pri juvenilnem idiopatskem artritisu
A 40 mg pre-filled syringe and a 40 mg prefilled pen are also available for use.
Za uporabo sta na voljo tudi 40 mg napolnjena injekcijska brizga in 40 mg napolnjen injekcijski peresnik.
Figure I Warning: Do not use the syringe if it shows any sign of damage.
Opozorilo: Injekcijske brizge ne uporabljajte, če je kakorkoli poškodovana.
Kromeya dose for paediatric patients with plaque psoriasis
Odmerjanje zdravila Kromeya pri pediatričnih bolnikih s psoriazo v plakih
• If your child has an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Kromeya.
• Če ima vaš otrok kakšno okuţbo, vključno z dolgotrajno ali omejeno okuţbo (npr. razjedo na nogi), se pred uporabo zdravila Kromeya posvetujte s svojim zdravnikom.
Adalimumab n=274
Adalimuma b n = 274
Crohn's disease is an inflammatory disease of the gut.
Crohnova bolezen je vnetna bolezen prebavil.
In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 10).
V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 10).
• Do not use an Kromeya pre-filled syringe that has been frozen or left in direct sunlight.
• Zdravila Kromeya napolnjena injekcijska brizga ne uporabljajte, če je bila brizga zamrznjena ali dlje časa izpostavljena neposredni sončni svetlobi.
Beyond 16 weeks, patients with inadequate response to Kromeya 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Od 16. tedna dalje lahko bolnikom z nezadostnim odzivom na zdravilo Kromeya 40 mg vsak drugi teden koristi povečanje odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
• lichenoid skin reaction (itchy reddish-purple skin rash).
• lihenoidna reakcija koţe (srbeč rdeče-vijolični koţni izpuščaj).
Kromeya dose for patients with enthesitis-related arthritis
Odmerjanje zdravila Kromeya pri bolnikih z artritisom, povezanim z entezitisom
No ALT elevations ≥3 X ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Do nobenih zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z adalimumabom pri pediatričnih bolnikih s psoriazo v plakih.
2 April 2019
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM 2. april 2019
Carriers of HBV who require treatment with Kromeya should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Nosilce HBV, ki potrebujejo zdravljenje z zdravilom Kromeya, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okuţbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
Kromeya 40 mg/0.8 mL solution for injection for paediatric use is supplied in a glass vial.
Kromeya 40 mg/0,8 ml raztopina za injiciranje za pediatrično uporabo je na voljo v stekleni viali.
Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab (see section 4.4).
V redkih primerih med obdobjem trţenja so pri bolnikih, zdravljenih z adalimumabom, poročali o hepatospleničnem limfomu celic T (glejte poglavje 4.4).
When needed (for example when you are travelling), a single Kromeya pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Če je potrebno (na primer kadar potujete), lahko posamezno napolnjeno injekcijsko brizgo Kromeya hranite pri sobni temperaturi (do 25 ºC) za največ 14 dni - zagotovite, da bo zaščitena pred svetlobo.
Figure 3: Kaplan-Meier curves summarizing time to treatment failure in the paediatric uveitis study
Slika 3: Kaplan-Meier-jeve krivulje povzemajo čas do neuspeha zdravljenja v študiji uveitisa pri pediatričnih bolnikih
Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab- treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Med temi koţnimi raki je bil deleţ (95 % interval zaupanja) skvamocelularnega karcinoma 2,7 (1,4; 5,4) na 1000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,6 (0,1; 4,5) na 1000 bolnikov-let v kontrolni skupini bolnikov.
• If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Kromeya.
• Če vaš otrok ima ali pa se pri njem razvija demielinizirajoča bolezen (bolezen, ki vpliva na izolacijsko plast okoli ţivcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko dobiva zdravilo Kromeya.
Patients demonstrating a Pediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Bolniki, ki so 16. teden dosegli odziv »Pediatric ACR« 30, so bili primerni za randomizacijo v dvojno slepo fazo in so nadaljnjih 32 tednov ali do zagona bolezni vsak drugi teden dobili adalimumab 24 mg/m
Of 207 patients who were randomised to adalimumab 40mg every other week, 114 patients continued on adalimumab 40 mg every other week for 5 years.
Od 207 bolnikov, ki so bili randomizirani na adalimumab 40 mg vsak drugi teden, jih je 114 nadaljevalo zdravljenje z adalimumab 40 mg vsak drugi teden še 5 let.
Polyarticular juvenile idiopathic arthritis from 2 years of age
Poliartikularni juvenilni idiopatski artritis od 2. starosti.
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 8).
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 8).
All doses/schedules of adalimumab in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in RA study III the same was seen at week 52.
V vseh štirih študijah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do meseca z vsemi odmerki/shemami adalimumaba izboljšal statistično značilno bolj kot s placebom; v študiji revmatoidnega artritisa III so isto ugotovili po 52 tednih.
Kromeya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Zdravilo Kromeya je indicirano za zdravljenje zmerno do hudo aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki so se ne odzovejo zadostno na običajno zdravljenje, na primer na kortikosteroide in 6-merkaptopurin (6-MP) ali azatioprin (AZA), ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
Pulmonary embolism interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion
pogosti astma, dispneja, kašelj občasni pljučni embolizem intersticijska pljučna bolezen, kronična obstruktivna pljučna bolezen, pnevmonitis, plevralna efuzija redki pljučna fibroza
In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in Adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients.
V kontroliranih preskušanjih z adalimumabom (začetni odmerek 80 mg v 0. tednu, ki mu sledi odmerek 40 mg vsak drugi teden z začetkom v 1. tednu) pri odraslih bolnikih z uveitisom, ki so trajala do 80 tednov, z mediano izpostavljenostjo 166,5 dni pri bolnikih zdravljenih z adalimumabom in 105,0 dni pri bolnikih v kontrolni skupini, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 2,4 % bolnikov zdravljenih z adalimumabom in pri 2,4 % bolnikov v kontrolni skupini.
Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 µg/mL (79% CV).
Po dajanju adalimumaba 0,8 mg/kg (do največ 40 mg) subkutano vsak drugi teden pediatričnim bolnikom s kronično psoriazo v plakih, so bile povprečne koncentracije adalimumaba v stanju dinamičnega ravnovesja pribliţno 7,4 ± 5,8 µg/ml (79 % KV).
Serious adverse reactions have been reported for adalimumab.
Poročali so tudi o resnih neţelenih učinkih v zvezi z adalimumabom.
Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 µg/ml.
Po subkutanem dajanju 40 mg adalimumaba vsak drugi teden odraslim bolnikom z ne-radiografskim aksialnim spondiloartritisom je bila povprečna (±SD) najmanjša koncentracija v stanju dinamičnega ravnovesja (merjena v 68. tednu) 8,0 ± 4,6 µg/ml.
The rate (95% confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Deleţ (95 % interval zaupanja) limfomov je bil 0,7 (0,2; 2,7) na 1000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,6 (0,1; 4,5) na 1000 bolnikov-let v kontrolni skupini bolnikov.
Initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg two weeks later.
Začetni odmerek je 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
6.3 Administer the Injection
6.3 Vstavite injekcijsko iglo
• Tell your doctor if you have lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
• Zdravniku morate povedati, če ste ţiveli ali potovali v predele, kjer so pogoste glivične okuţbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
If your child becomes pregnant, you should see your child's doctor.
Če vaš otrok zanosi, mora obiskati zdravnika.
PGA: Clear/minimal b a
PGA: čisto/minimalno b a
The recommended dose of Kromeya for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Priporočeni odmerek zdravila Kromeya pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 4).
Kromeya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Zdravilo Kromeya je indicirano za zdravljenje kroničnega neinfekcijskega anteriornega uveitisa pri bolnikih, starejših od 2 let, ki se niso ustrezno odzvali ali ne prenašajo konvencionalnega zdravljenja, ali pri katerih konvencionalno zdravljenje ni primerno.
• Continue to HOLD the pre-filled pen firmly.
• Napolnjen injekcijski peresnik močno DRŢITE še naprej.