natgillin/translations-raw huggingface dataset:
• skin infections (including cellulitis and shingles)
• okužbe kože (vključno s celulitisom in pasovcem)
The double-blind period was followed by an open-label period during which patients receive Humira 40 mg every other week subcutaneously for up to an additional 144 weeks.
Dvojno slepi periodi je sledila odprta perioda, v kateri so bolniki prejemali zdravilo Humira 40 mg vsak drug teden subkutano do dodatnih
Sustained Remission
Avtoimunska dogajanja
• pulmonary embolism (blockage in an artery of the lung)
• pljučni embolizem (zamašitev arterije v pljučih)
• systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)
• sistemski eritematozni lupus (vključno z vnetjem kože, srca, pljuč, sklepov in drugih organskih sistemov)
In Period A, patients received placebo or Humira at an initial dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every week starting at Week 4 to Week 11.
V obdobju A so bolniki prejeli placebo ali zdravilo Humira v začetnem odmerku 160 mg v 0. tednu, nato 80 mg v 2. tednu in 40 mg vsak teden od vključno 4. tedna do 11. tedna.
There is limited safety experience in patients undergoing arthroplasty while receiving Humira.
Izkušnje z varnostjo pri bolnikih, ki so jim med zdravljenjem z zdravilom Humira opravili artroplastiko, so omejene.
Humira is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section
Zdravilo Humira je indicirano za zdravljenje aktivnega artritisa, povezanega z entezitisom pri bolnikih, starih 6 let in več, ki so se neustrezno odzvali ali so intolerantni za običajno zdravljenje
After completing the injection, place a cotton ball or gauze pad on the skin over the injection site.
Po zaključenem injiciranju položite na mesto injiciranja blazinico vate ali zloženec iz gaze.
• Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
• aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis
Humira can reduce the number of nodules and abscesses caused by the disease and the pain that is often associated with the disease.
Zdravilo Humira lahko zmanjša število vozličev in ognojkov, ki jih povzroča ta bolezen.
First dose of 40 mg, followed by 40 mg one week later.
Prvi odmerek je 40 mg, kateremu sledi 40 mg en teden kasneje.
A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with Humira.
Pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, Crohnovo boleznijo, ulceroznem kolitisom in hidradenitis suppurativa so opazili tudi naglo znižanje koncentracij CRP po zdravljenju z zdravilom Humira.
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.
1 sterile vial adapter
1 sterilni adapter za vialo 2 alkoholna zloženca
Humira 80 mg solution for injection in pre-filled pen Humira 80 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe.
Humira 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Zdravilo Humira 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku za enkratno uporabo, ki ga uporabi bolnik, vsebuje napolnjeno injekcijsko brizgo.
• If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive Humira.
• Če imate ali pa se pri vas razvija demielinizirajoča bolezen, kot je multipla skleroza, bo zdravnik presodil, ali lahko dobivate oziroma tudi še nadalje dobivate zdravilo Humira.
In patients with polyarticular JIA who were 2 to < 4 years old or aged 4 and above weighing < 15 kg dosed with adalimumab 24 mg/m2 , the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg/ml (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg/ml (71.2% CV) with concomitant methotrexate.
Pri bolnikih s poliartikularnim JIA, starih od 2 do < 4 leta ali starih 4 leta ali več in s telesno maso < 15 kg, ki so prejemali adalimumab v odmerku 24 mg/m2, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja 6,0 ± 6,1 µg/ml (KV 101 %) med uporabo adalimumaba brez metotreksata in 7,9 ± 5,6 µg/ml (KV 71,2 %) med sočasno uporabo metotreksata.
In adult patients with uveitis, a loading dose of 80 mg adalimumab on Week 0 followed by 40 mg adalimumab every other week starting at Week 1, resulted in mean steady-state concentrations of approximately 8 to 10 g/mL.
Pri odraslih bolnikih z uveitisom je polnilni odmerek 80 mg adalimumaba v 0. tednu, ki mu je sledil odmerek 40 mg adalimumaba vsak drugi teden z začetkom v 1. tednu, povzročil povprečno koncentracijo v stanju dinamičnega ravnovesja približno 8 do 10 µg/ml.
• Polyarticular juvenile idiopathic arthritis,
• poliartikularni juvenilni idiopatski artritis,
• Psoriatic arthritis
• psoriatičnega artritisa
Throw the cap away.
Pokrovček zavrzite.
If these medicines do not work well enough, your child will be given Humira to treat his/her polyarticular juvenile idiopathic arthritis.
Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa prejel zdravilo Humira.
Minimum, median and maximum dose
Izhodiščno število bolnikov n (%) Najmanjši, srednji in največji odmerek
Low Dose 20/10 mg eow N = 95
Majhni odmerek 20/10 mg vsak teden dan N=95
The needle cover, alcohol pad, cotton ball or gauze pad, blister and packaging may be put in your household waste.
V gospodinjske odpadke lahko zavržete pokrovček igle, alkoholni zloženec, blazinico vate ali zložene gaze, omot in embalažo.
• It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
• Zelo je pomembno, da zdravniku poveste, če ste že kdaj imeli tuberkulozo ali ste bili v tesnem stiku s kom, ki je imel tuberkulozo.
In addition cases of non-melanoma skin cancer have been observed in patients taking Humira.
Poleg tega so pri bolnikih, zdravljenih z zdravilom Humira, opazili primere nemelanomskega kožnega raka.
Placebo/MTXHumira/MTX (95% Confidence Interval p-value
Zdravilo Humira/MTX 40 mg vsak drugi teden placebo/MTXzdravilo Humira/MTX (95 % interval zaupanjab)
Humira treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at Week 24) compared with 0.0 ± 1.9; (p< 0.001) in the Humira group (at Week 48).
(povprečje ± standardni odklon) 0,8 ± 2,5 v skupini s placebom (po 24 tednih) in 0,0 ± 1,9; (p < 0,001) v skupini z zdravilom Humira (po 48 tednih).
• Your belly (abdomen) at least 5 cm from your belly button (navel)
• na trebuhu; najmanj 5 cm oddaljeno od popka
Table 19 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission Standard Dose 40/20 mg eow
Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule Standardni odmerek 40/20 mg vsak drugi teden
• Do not hold or pull the plunger when removing the needle cover
• Pri odstranjevanju pokrovčka igle ne držite in ne potegnite bata.
Surgery
Okence
Your child's doctor may increase the dose frequency to 20 mg every week.
Zdravnik vašemu otroku lahko poveča pogostnost odmerjanja na 20 mg vsak teden.
• The following instructions explain how to give your child a subcutaneous injection of Humira using the pre-filled syringe.
• Naslednja navodila pojasnjujejo, kako vašemu otroku subkutano injicirate zdravilo Humira z napolnjeno injekcijsko brizgo.
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 25.
V 4. tednu so bili bolniki glede na njihovo telesno maso v tem času randomizirani v razmerju 1:1 bodisi v vzdrževalni režim z majhnim odmerkom ali vzdrževalni režim s standardnim odmerkom, kot kaže preglednica 25.
Solution for injection 1 pre-filled syringe 1 alcohol pad
raztopina za injiciranje 1 napolnjena injekcijska brizga 1 alkoholni zloženec
Enthesitis-related arthritis Age or body weight
Artritis, povezan z entezitisom Starost ali telesna masa
Worsening or new onset of psoriasis(including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia1),
pogosti poslabšanje ali pojav psoriaze (vključno s palmoplantarno pustularno psoriazo)1), urtikarija,
Humira 40 mg solution for injection in pre-filled pen Humira 40 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe.
Humira 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Zdravilo Humira 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku za enkratno uporabo, ki ga uporabi bolnik, vsebuje napolnjeno injekcijsko brizgo.
There is no relevant use of Humira in patients aged less than 2 years for this indication.
Uporaba zdravila Humira pri bolnikih, starih manj kot 2 leti, za to indikacijo ni primerna.
If you take Humira the risk of getting lymphoma, leukemia, or other cancers may increase.
Če uporabljate zdravilo Humira, se vam lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
• Ulcerative colitis and
• ulcerozni kolitis in
Table 16 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebom
• There have been cases of cancers, other than lymphoma, in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
• Pri bolnikih s posebno boleznijo pljuč, t.i. kronično obstruktivno pljučno boleznijo (KOPB), zdravljenih z nekim drugim zaviralcem TNF, so bili primeri raka, ki niso bili limfomi.
No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during Humira trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis).
Pri 249 pediatričnih bolnikih z juvenilnim idiopatskim artritisom (s poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), ki so bili med preskušanji zdravila Humira zdravilu izpostavljeni 655,6 bolnikov-let, niso ugotovili nobenega malignoma.
Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Preglednica 18: Študija pri psoriazi II (CHAMPION)
• high blood measurements for white blood cells
• visoke krvne vrednosti za bele krvne celice
Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 10).
Ocena psoriaze nohtov je vključevala prilagojeni indeks izrazitosti psoriaze nohtov (mNAPSI - Modified Nail Psoriasis Severity Index), zdravnikovo globalno oceno psoriaze nohtov (PGA-F - Physician's Global Assessment of Fingernail Psoriasis) in indeks izrazitosti psoriaze nohtov (NAPSI - Nail Psoriasis Severity Index) (glejte preglednico 10).
Humira 40 mg solution for injection in pre-filled syringe Humira 40 mg solution for injection in pre-filled pen
Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Humira 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
If you do not respond well enough to these medicines, you will be given Humira to reduce the signs and symptoms of your Crohn's disease.
Če se nanje ne boste odzvali dovolj dobro, boste za zmanjšanje znakov in simptomov Crohnove bolezni dobili zdravilo Humira.
If your child gets any side effects, talk to your doctor or pharmacist.
- Če vaš otrok dobi kateri koli neželeni učinek, se posvetujte z njegovim zdravnikom ali farmacevtom.
Placebo/ MTX n=200
placebo/ MTXc n = 200
For the 2, 4 and 6 pre-filled pen packs, each pre-filled pen comes with 1 alcohol pad.
Pakiranja po 2, 4 in 6 napolnjenih injekcijskih peresnikov imajo k vsakemu napolnjenemu injekcijskemu peresniku priložen 1 alkoholni zloženec.
Opportunistic infections, including invasive fungal infections have been observed in patients receiving Humira.
Pri bolnikih, ki so dobivali zdravilo Humira, so opažali oportunistične okužbe, vključno z invazivnimi glivičnimi okužbami.
P Value
P vrednost1
The recommended dose of Humira for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Priporočeni odmerek zdravila Humira pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 4).
• On the front of your thighs or
• na sprednji strani stegen ali
• If you are about to have surgery or dental procedures please inform your doctor that you are taking Humira.
• Če boste imeli kirurški poseg ali poseg na zobeh, prosimo, povejte svojemu zdravniku, da jemljete zdravilo Humira.
Giving the injection
KORAK Injekcijska brizga
Humira 80 mg solution for injection in pre-filled syringe Humira 80 mg solution for injection in pre-filled pen
Humira 80 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Humira 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Humira is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Zdravilo Humira se uporablja za zdravljenje hudega ankilozirajočega spondilitisa in aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis pri odraslih.
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 g/ml (without concomitant methotrexate) and 8 to 9 g/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 približno 5 μg/ml (brez sočasne uporabe metotreksata) in od 8 do 9 μg/ml (s sočasno uporabo metotreksata).
Never recap a needle.
NIKDAR ne nameščajte pokrovčka nazaj na iglo.
Humira 80 mg solution for injection in pre-filled syringe Humira 80 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).
Humira 80 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zdravilo Humira 80 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) za enkratno uporabo z batno zaporko (bromobutilni kavčuk) in igle z varovalnim pokrovčkom (termoplastični elastomer).
If you accidentally inject a larger amount of Humira liquid, or if you inject Humira more frequently than told to by your doctor, call your doctor and tell him/her that your child has taken more.
Če ste uporabili večji odmerek zdravila Humira, kot bi smeli Če pomotoma injicirate večjo količino zdravila Humira tekočine ali če injicirate zdravilo Humira pogosteje, kot vam je naročil zdravnik, se morate posvetovati z njim in mu povedati, da je vaš otrok uporabil večji odmerek.
Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before your child is given Humira and during treatment with Humira.
Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden vaš otrok prejme zdravilo Humira in med zdravljenjem z njim.
Subjects who flared during the double-blind period were allowed Humira 40 mg eow rescue therapy for at least 12 weeks.
Preiskovanci, pri katerih je v dvojno slepem obdobju prišlo do ponovnega zagona bolezni, so kot rešilno zdravljenje prejemali zdravilo Humira 40 mg vsak drugi teden vsaj 12 tednov.
Hypertension, flushing, haematoma
Žilne bolezni pogosti hipertenzija, zardevanje, hematom
If you forget to give yourself an injection, you should inject the next dose of Humira as soon as you remember.
Če si pozabite dati injekcijo, si morate naslednji odmerek zdravila Humira injicirati, čim se spomnite.
If you accidentally inject a smaller amount of Humira liquid, or if you inject Humira 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 ste uporabili manjši odmerek zdravila Humira, kot bi morali Če pomotoma injicirate manjši odmerek zdravila Humira, ali če zdravilo Humira 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.
Humira is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Zdravilo Humira se uporablja za zdravljenje Crohnove bolezni pri odraslih in otrocih, starih 6 do 17 let.
• If you have mild heart failure and are being treated with Humira, your heart failure status must be closely monitored by your doctor.
• Če imate blago srčno popuščanje in se zdravite z zdravilom Humira, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
• signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
• znake okužbe, npr. zvišano telesno temperaturo, splošno slabo počutje, rane, težave z zobmi,
When the injection is completed, slowly pull the needle out of the skin while keeping the pre-filled syringe at the same angle.
Ko je injiciranje zaključeno, počasi odstranite iglo iz kože,
Humira 40 mg solution for injection in pre-filled syringe with automatic needle guard Humira 40 mg solution for injection in single-use pre-filled syringe with automatic needle guard.
Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi z avtomatskim ščitnikom za iglo Zdravilo Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi z avtomatskim ščitnikom za iglo za enkratno uporabo.
• If your child has a severe infection, including active tuberculosis (see “Warnings and precautions”).
• če ima vaš otrok hudo okužbo, vključno z aktivno tuberkulozo (glejte "Opozorila in previdnostni ukrepi").
Hold the pre-filled pen with the grey cap (1) pointing up.
Primite napolnjeni injekcijski peresnik tako, da bo sivi pokrovček (1) obrnjen navzgor.
Injection site pain
Bolečine na mestu injiciranja
Throw away the used pre-filled syringe in a special disposal container as instructed by your doctor, nurse or pharmacist.
Uporabljeno napolnjeno injekcijsko brizgo zavrzite v poseben zabojnik, kot vam je naročil zdravnik, medicinska sestra ali farmacevt.
• shortness of breath
• hitro zadihanje
• It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Humira.
• Za otroke je priporočljivo, da pred začetkom zdravljenja z zdravilom Humira opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
• In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
• V redkih primerih, zlasti če vaš otrok uporablja druga zdravila, ki zavirajo imunski sistem, je reaktivacija HBV lahko življenjsko ogrožajoča.
In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the Humira treated patients and 1.46 per patient year in the placebo and active control-treated patients.
V kontroliranih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, pri odraslih in otrocih je bil delež okužb 1,51 na bolnikov-let med bolniki, ki so dobivali zdravilo Humira, in 1,46
Humira 20 mg solution for injection in pre-filled syringe for paediatric use is supplied as a sterile solution of 20 mg adalimumab dissolved in 0.2 ml solution.
Zdravilo Humira 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi za uporabo pri pediatrični populaciji je na voljo kot sterilna raztopina 20 mg adalimumaba, raztopljenega v 0,2 ml raztopine.
Your doctor should test you for HBV. Humira can cause reactivation of HBV in people who carry this virus.
Zdravilo Humira lahko pri nosilcih HBV povzroči reaktivacijo tega virusa.
• moderate to severe Crohn's disease in children and adolescents aged 6 to 17 years.
• zmerno do hudo aktivne Crohnove bolezni pri otrocih in mladostnikih, starih od 6 do 17 let.
No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during a Humira trial in paediatric patients with uveitis.
Pri 60 pediatričnih bolnikih z uveitisom, ki so bili med preskušanji zdravila Humira izpostavljeni 58,4 bolnikov-let, niso ugotovili nobenega malignoma.
a Partial Remission ASDAS
ASASa delno izboljšanje
• If your child has active tuberculosis or other severe infections (see “Warnings and precautions”).
• če ima vaš otrok aktivno tuberkulozo ali druge hude okužbe (glejte "Opozorila in previdnostni ukrepi").
Finger Grip
Držalo za prste
What you need to know before your child uses Humira
Kaj morate vedeti, preden bo vaš otrok uporabil zdravilo Humira Ne uporabljajte zdravila Humira
In patients with Crohn's disease, the loading dose of 80 mg Humira on Week 0 followed by 40 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 5.5 g/ml during the induction period.
Pri bolnikih s Crohnovo boleznijo doseže polnilni odmerek 80 mg zdravila Humira na 0. teden, ki mu sledi 40 mg zdravila Humira 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 5,5 μg/ml.
• moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.
• zmernega do hudega hidradenitis suppurativa pri mladostnikih, starih od 12 do 17 let.
Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg
Otroci in mladostniki od 4. do 17. leta starosti, ki tehtajo od 15 kg do manj kot 30 kg
• After proper training, the injection can be given by your child or given by another person, for example, a family member or friend.
• Po ustreznem urjenju si lahko injekcije daje vaš otrok sam ali mu jih daje kdo drug, na primer svojec ali prijatelj.
After two further weeks, continue with a dosage of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
Po nadaljnjih dveh tednih nadaljujte z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden, kot vam je predpisal zdravnik.
First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later.
Prvi odmerek je 80 mg (dve 40 mg injekciji v enem dnevu), čemur sledi 40 mg dva tedna kasneje.
Talk to your doctor or pharmacist before using Humira.
Pred začetkom uporabe zdravila Humira se posvetujte z zdravnikom ali farmacevtom.
2 alcohol pads
• 1 alkoholni zloženec
In controlled Phase 3 trials of Humira in patients with plaque psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8% of Humira-treated patients and 1.8% of control-treated patients.
V kontroliranih preskušanjih faze 3 z zdravilom Humira pri bolnikih s psoriazo v plakih in s trajanjem kontrolnega obdobja od 12 do 24 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 1,8 % bolnikov, zdravljenih z zdravilom Humira, in pri 1,8 % bolnikov v kontrolni skupini.
If a faster response is required, the doctor may prescribe a first dose of 80 mg (one 80 mg injection), followed by 40 mg two weeks later.
Če je potreben hitrejši odziv, lahko zdravnik predpiše začetni odmerek 80 mg (eno 80 mg injekcijo), čemur sledi 40 mg dva tedna kasneje.