natgillin/translations-raw huggingface dataset:
Possible side effects 5 How to store Humira 6.
Možni neželeni učinki 5 Shranjevanje zdravila Humira 6.
WHAT HUMIRA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO HUMIRA IN ZA KAJ GA UPORABLJAMO
Humira is intended for treatment of rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’ s disease, and psoriasis.
Humira je namenjena za zdravljenje revmatoidnega artritisa, poliartikularnega juvenilnega idiopatskega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa, Crohnove bolezni in luskavice (psoriaze).
Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease and psoriasis.
Adalimumab se veže na specifično beljakovino (tumorje nekrotizirajoči faktor ali TNF), ki je pri vnetnih boleznih, kakršne so revmatoidni artritis, poliartikularni juvenilni idiopatski artritis, psoriatični artritis, ankilozirajoči spondilitis, Crohnova bolezen in luskavica (psoriaza), prisoten v večji koncentraciji.
If you do not respond well enough to these medicines, you will be given Humira to treat your rheumatoid arthritis.
Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili Humiro.
Humira can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Humiro je mogoče uporabljati tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa brez predhodnega zdravljenja z metotreksatom.
Humira has been shown to slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Dokazano je, da Humira upočasni okvaro sklepnega hrustanca in kosti, ki jo povzroča ta bolezen in izboljšuje telesno delovanje.
Usually, Humira is used with methotrexate.
Humiro ponavadi uporabljamo z metotreksatom.
If your doctor determines that methotrexate is inappropriate, Humira can be given alone.
Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko Humiro dobivate samo.
Polyarticular juvenile idiopathic arthritis is an inflammatory disease, affecting one or more joints, with diagnosis typically occurring in children under the age of 16 years.
Morda boste najprej dobili druga imunomodulirajoča
You may first be given other 146 disease-modifying medicines, such as methotrexate.
146 zdravila, npr. metotreksat.
If you do not respond well enough to these medicines, you will be given Humira to treat your polyarticular juvenile idiopathic arthritis.
Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa dobili Humiro.
Humira has been shown to slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Humira dokazano upočasni napredovanje prizadetosti sklepnih hrustancev in kosti, ki jo povzroči bolezen, in izboljša telesno delovanje.
If you do not respond well enough to these medicines, you will be given Humira to reduce the signs and symptoms of your disease.
Če se nanje ne boste odzvali dovolj dobro, boste za zmanjšanje znakov in simptomov bolezni dobili Humiro.
Crohn’ s disease is an inflammatory disease of the digestive tract.
Crohnova bolezen je vnetna bolezen prebavil.
If you have Crohn’ s disease you will first be given other medicines.
Če imate Crohnovo bolezen, boste najprej dobili druga zdravila.
If you do not respond well enough to these medicines, you will be given Humira to reduce the signs and symptoms of your disease.
Če se nanje ne boste odzvali dovolj, boste za zmanjšanje znakov in simptomov bolezni dobili zdravilo Humira.
Psoriasis
Luskavica (psoriaza)
Psoriasis is an inflammatory disease of the skin.
Luskavica (psoriaza) je vnetna bolezen kože.
If you have moderate to severe plaque psoriasis, you will first be given other medicines or e. g. phototherapy.
Če imate zmerno do hudo psoriazo v plakih, boste najprej deležni drugačnega zdravljenja, npr. fototerapije.
If you do not respond well enough to these treatments, you will be given Humira to reduce the signs and symptoms of your psoriasis.
Če se na takšno zdravljenje ne boste odzvali dovolj, boste za zmanjšanje znakov in simptomov psoriaze dobili zdravilo Humira.
BEFORE YOU USE HUMIRA
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO HUMIRA
Do not use Humira
Ne uporabljajte zdravila Humira
• If you are allergic (hypersensitive) to adalimumab or any of the other ingredients of Humira.
• če ste alergični na (preobčutljivi za) adalimumab ali katerokoli sestavino zdravila Humira.
• If you have a severe infection, including active tuberculosis (see “ Take special care with Humira”).
• če imate hudo okužbo, vključno z aktivno tuberkulozo (glejte "Bodite posebno pozorni pri uporabi Humire").
It is important that you tell your doctor if you have symptoms of infections, e. g. fever, wounds, feeling tired, dental problems.
Pomembno je, da zdravniku poveste, če imate simptome okužb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali težave z zobmi.
It is important to tell your doctor if you have had or have a serious heart condition (see “ Take special care with Humira”).
Pomembno je, da zdravniku poveste, če ste imeli ali imate kakšno resno bolezen srca (glejte "Bodite posebno pozorni pri uporabi Humire").
Take special care with Humira
Bodite posebno pozorni pri uporabi Humire
• If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and contact your doctor immediately.
• Če doživite alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, Humire ne injicirajte več in se takoj posvetujte s svojim zdravnikom.
• If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Humira.
• Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo Humire posvetujte s svojim zdravnikom.
• You might get infections more easily while you are receiving Humira treatment.
147 • Med zdravljenjem s Humiro se lahko poveča dovzetnost za okužbe.
These infections may be serious and include tuberculosis, infections caused by viruses, fungi or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening.
Te okužbe so lahko resne in vključujejo tuberkulozo, okužbe, ki jih povzročijo virusi, glive ali bakterije ali druge oportunistične okužbe, in sepso, in so lahko v redkih primerih smrtno nevarne.
147 It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems.
Pomembno je, da zdravniku poveste, če doživite simptome, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali težave z zobmi.
• As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check you for signs and symptoms of tuberculosis before starting Humira.
• Ker so bili pri bolnikih, zdravljenih s Humiro, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja s Humiro preiskal glede znakov in simptomov tuberkuloze.
• Advise your doctor if you reside or travel in regions where fungal infections such as histoplasmosis coccidioidomysis or blastomycosis are endemic.
• Zdravniku morate povedati, če živite na območju ali potujete v predele, kjer so endemične glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
Humira can cause reactivation of HBV in people who carry this virus.
Humira lahko pri nosilcih HBV povzroči reaktivacijo tega virusa.
• If you are about to undergo 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 Humiro.
• If you have demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive Humira.
• Če imate demielizirajočo bolezen, kot je multipla skleroza, bo zdravnik presodil, ali lahko dobivate Humiro.
• Some vaccines should not be given while receiving Humira.
• Med zdravljenjem s Humiro se ne sme uporabljati nekaterih cepiv.
• If you have mild heart failure and you are being treated with Humira, your heart failure status must be closely monitored by your doctor.
• Če imate blago srčno popuščanje in se zdravite s Humiro, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
If you develop new or worsening symptoms of heart failure (e. g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. Your doctor will decide if you should receive Humira.
On se bo odločil, ali lahko dobivate Humiro.
• There have been very rare cases of certain kinds of cancer in patients taking Humira or other TNF blockers.
• Med bolniki, ki so jemali Humiro ali druge zaviralce TNF, so se pojavili zelo redki primeri določenih vrst raka.
People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting ymphoma, which is a kind of cancer that affects the lymph system.
Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom, to je rakom limfatičnega sistema.
If you take Humira your risk may increase.
Če jemljete Humiro, se ta verjetnost poveča.
On rare occasions, a specific and severe type of lymphoma, has been observed in patients taking Humira.
V redkih primerih so pri bolnikih, ki dobivajo Humiro, opazili specifično in resno obliko limfoma.
Some of those patients were also treated with azathioprine or 6- mercaptopurine.
Nekateri od teh bolnikov so bili zdravljeni tudi z azatioprinom ali 6- merkaptopurinom.
In addition very rare cases of non-melanoma skin cancer have been observed in patients taking Humira.
Poleg tega so pri bolnikih, zdravljenih s Humiro,
148 blocker.
148 opazili zelo redke primere nemelanomskega kožnega raka.
Humira can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDS).
Humiro se lahko uporablja skupaj z metotreksatom ali nekaterimi imunomodulirajočimi antirevmatičnimi zdravili (sulfasalazinom, hidroksiklorokinom, leflunomidom in pripravki zlata za injiciranje), steroidi in zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili.
You should not take Humira with medicines containing the active substance, anakinra or abatacept.
Humire ne smete jemati z zdravili, ki vsebujejo učinkovini anakinro ali abatacept.
Using Humira with food and drink
Uporaba zdravila Humira skupaj s hrano in pijačo
Since Humira is injected under the skin (subcutaneously), food and drink should not affect Humira.
Ker se Humira injicira pod kožo (subkutano), hrana in pijača naj ne bi vplivali na Humiro.
The effects of Humira in pregnant women are not known and so the use of Humira in pregnant women is not recommended.
Vplivi Humire pri nosečnicah niso znani, zato uporaba tega zdravila pri nosečih ženskah ni priporočljiva.
You are advised to avoid becoming pregnant and must use adequate contraception while using Humira and for at least 5 months after the last Humira treatment.
Priporočljivo je, da ne zanosite, zato morate med zdravljenjem s Humiro in vsaj še 5 mesecev po zadnjem odmerku uporabljati ustrezno kontracepcijsko zaščito.
If you are a breast-feeding mother, you should stop breast-feeding during Humira treatment and for at least 5 months after the last Humira treatment.
Če dojite, morate dojenje med zdravljenjem s Humiro prekiniti in ne smete dojiti vsaj še 5 mesecev po zadnjem odmerku Humire.
Humira may have a minor influence on your ability to drive and use machines.
Humira ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
Dizziness (including room spinning sensation, blurred vision and tiredness) may occur after you take Humira.
Po dajanju Humire se lahko pojavi omotica (vključno z vrtoglavico, motnjami vida in utrujenostjo).
HOW TO USE HUMIRA
KAKO UPORABLJATI ZDRAVILO HUMIRA
Always take Humira exactly as your doctor has told you.
Pri uporabi zdravila Humira natančno upoštevajte zdravnikova navodila.
Humira is injected under the skin (subcutaneous use).
Humira se injicira pod kožo (subkutana uporaba).
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, aged 13 years and above, is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek Humire za bolnike s poliartikularnim juvenilnim idiopatskim artritisom, stare nad 13 let, je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
The usual dose regimen for Crohn’ s disease is 80 mg at Week 0 and followed by 40 mg every other week starting at Week 2.
Običajna shema odmerjanja pri Crohnovi bolezni je 80 mg 0. teden, čemur sledi 40 mg vsak drugi teden od 2. tedna naprej.
In cases where a more rapid response is required your doctor may prescribe a dose of 160 mg at Week 0 (as 4 injections in one day or 2 injections per day for two consecutive days), 80 mg (2 injections) at Week 2, and thereafter as 40 mg (1 injection) every other week.
Kadar je potreben hitrejši odziv, vam zdravnik lahko predpiše odmerek
Depending on your response, your doctor may increase the dose to 40 mg every week.
149 160 mg 0. teden (v 4 injekcijah na en dan ali v 2 injekcijah dva dni zapored), 80 mg (2 injekciji) 2. teden in potem 40 mg (1 injekcija) vsak drugi teden.
The usual dose for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting
Odvisno od vašega odziva lahko zdravnik poveča odmerek na 40 mg vsak drugi teden.
149 one week after the initial dose.
Običajno odmerjanje za odrasle z luskavico (psoriazo) je začetni odmerek 80 mg, ki mu sledi 40 mg čez en teden in nato 40 mg vsak drugi teden.
You should continue to inject Humira for as long as your doctor has told you.
Humiro je treba injicirati toliko časa, kolikor vam je naročil zdravnik.
In rheumatoid arthritis, methotrexate is continued while using Humira.
Pri revmatoidnem artritisu se uporaba metotreksata med uporabo Humire nadaljuje.
If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, your doctor may decide to give 40 mg adalimumab every week.
Če imate revmatoidni artritis in če hkrati s Humiro ne dobivate metotreksata, vam bo zdravnik morda predpisal 40 mg adalimumaba vsak teden.
Instructions for preparing and giving an injection of Humira:
Navodila za pripravo in injiciranje Humire
The following instructions explain how to inject Humira.
Spodnja navodila pojasnjujejo, kako injicirati Humiro.
You will be instructed by your doctor or his/ her assistant on the technique of self-injection.
Zdravnik ali njegovo osebje vas bodo naučili, kako si zdravilo injicirate sami.
• Wash your hands thoroughly • Set up the following items on a clean surface
• Dobro si umijte roke. • Na čisto površino pripravite:
One vial of Humira for injection One syringe with fixed needle Two alcohol pads
eno vialo Humire za injiciranje eno brizgo s fiksno iglo dva alkoholna zloženca
150 2) Choosing and preparing an injection site
150 2) Izbira in priprava injekcijskega mesta
• Choose a site on your thigh or stomach
• Izberite mesto na stegnu ali trebuhu.
3) Injecting Humira
3) Injiciranje Humire
Preparing the Humira dose for injection • Do NOT shake the vial. • Remove the plastic cap from the Humira vial.
Priprava odmerka Humire za injiciranje • Viale NE STRESAJTE. • Z viale Humire odstranite plastični pokrovček.
Do NOT remove the grey stopper or aluminium ring around the top of the vial. • Use a new alcohol pad to clean the grey stopper on the vial.
NE ODSTRANITE sivega zamaška ali aluminijastega obročka na vrhu viale. • Uporabite nov alkoholni zloženec in z njim očistite sivi zamašek viale.
After cleaning, do not touch the stopper with your hands. • Remove cap from needle syringe, being careful not to touch needle or let it touch any surface. • Make sure that the plunger is fully inserted into the syringe.
Po očiščenju se zamaška ne dotikajte več z rokami. • Odstranite pokrovček z igle na brizgi; pazite, da se igle pri tem ne dotaknete in da se z njo česa ne dotaknete. • Prepričajte se, da je bat do konca potisnjen v brizgo.
If the needle is correctly lined up, you should feel a slight resistance and then a “ pop” as the needle goes through the centre of the stopper.
Če je igla pravilno naravnana, boste čutili rahel upor in potem "pok", ko igla predre osrednji del zamaška.
If the needle is not correctly lined up with the centre of the stopper, you will feel constant resistance as it goes through the stopper and no “ pop .” The needle may then enter at an angle and bend, break or prevent proper removal of the vial contents.
V takšnem primeru lahko igla vstopi pod kotom in se zvije, zlomi ali prepreči pravilno odstranitev vsebine viale.
If this happens, do not use the syringe or vial. • With the needle still in the vial, turn the vial upside down at eye level.
Če se to zgodi, brizge ali viale ne uporabite. • Medtem ko je igla še vedno v viali, v višini oči obrnite vialo na glavo.
Slowly pull the plunger back to draw solution into the syringe. • With the needle still inserted in the vial, check the syringe for air bubbles.
Počasi izvlecite bat, da boste raztopino potegnili v brizgo. • Medtem ko je igla še vedno v viali, preverite, ali so v brizgi zračni mehurčki.
When you do this, if you accidentally push some solution back into the vial, pull slowly back in the plunger to draw the entire contents of the vial back into the syringe. • Pull the needle completely out of the vial.
Če pri tem nazaj v vialo potisnete nekaj raztopine, bat počasi potegnite nazaj, da boste celotno vsebino viale dobili nazaj v brizgo. • Iglo popolnoma potegnite iz viale.
151 Injecting Humira • With one hand, gently grasp the cleaned areas of skin and hold firmly • With the other hand, hold syringe at 45-degree angle to skin, with the grooved side up.
Injiciranje Humire • Z eno roko obzirno primite očiščeni predel kože in ga trdno držite. • Z drugo roko držite brizgo pod kotom 45 stopinj na kožo, z užlebljenim delom obrnjenim navzgor.
• With one quick, short motion, push needle all the way into skin • Release the skin with the first hand • Push plunger to inject solution – it can take from 2 to 5 seconds to empty the syringe • When the syringe is empty, remove the needle from skin, being careful to keep it at the same angle as when it was inserted • Using your thumb or a piece of gauze, apply pressure over the injection site for 10 seconds.
Pri tem pazite, da jo boste držali pod enakim kotom, pod katerim ste jo zabodli. • S palcem ali koščkom gaze 10 sekund pritiskajte na injekcijsko mesto.
• The Humira syringe should NEVER be reused.
• Brizge s Humiro NIKDAR ne smete ponovno uporabiti.
NEVER recap a needle • After injecting Humira, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist. • Keep this container out of the reach and sight of children
NIKDAR ne nameščajte pokrovčka nazaj na iglo. • Po injiciranju Humire porabljeno brizgo takoj zavrzite v poseben vsebnik, kot vam je naročil zdravnik, medicinska sestra ali farmacevt. • Ta vsebnik shranjujte nedosegljivo otrokom.
If you use more Humira than you should:
Če ste uporabili večji odmerek Humire, kot bi smeli
If you accidentally inject Humira more frequently than told to by your doctor, you should call your doctor and tell him/ her that you have taken more.
Če pomotoma injicirate Humiro pogosteje, kot vam je naročil zdravnik, se morate posvetovati z njim in mu povedati, da ste uporabili večji odmerek.
If you forget to take Humira:
Če ste pozabili vzeti Humiro
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 Humire injicirati, čim se spomnite.
Like all medicines, Humira can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi Humira neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Side effects may occur at least up to 5 months after the last Humira injection.
Neželeni učinki se lahko pojavijo vsaj še 5 mesecev po zadnji injekciji Humire.
Tell your doctor immediately if you notice any of the following: • Severe rash, hives or other signs of allergic reaction; • Swollen face, hands, feet; • Trouble breathing, swallowing;
Svojemu zdravniku takoj povejte, če opazite kaj od naslednjega: • hud izpuščaj, koprivnico ali druge znake alergijske reakcije; • oteklost obraza, dlani in stopal; • težave pri dihanju, požiranju; • težko dihanje ob naporu ali med ležanjem ali otekanje nog;
152 • Shortness of breath with exertion or upon lying down or swelling of the feet; • Signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.
152 • znaki in simptomi, ki nakazujejo bolezni krvi, npr. trdovratna zvišana telesna temperatura, modrice, krvavitve, bledica.
Tell your doctor as soon as possible if you notice any of the following: • Signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination; • Feeling weak or tired; • Coughing; • Tingling; • Numbness; • Double vision; • Arm or leg weakness; • A bump or open sore that does n't heal.
Zdravniku čim prej povejte, če opazite kaj od naslednjega: • znake okužbe, npr. zvišano telesno temperaturo, splošno slabo počutje, rane, težave z zobmi, pekoč občutek med uriniranjem; • občutek šibkosti ali utrujenosti; • kašelj; • mravljinčenje; • omrtvelost; • dvojni vid; • šibkost rok ali nog; • bula ali odprta rana, ki se ne zaceli.
The symptoms described above can be signs of the below listed side effects, which have been observed with Humira:
Opisani simptomi so lahko znaki naslednjih neželenih učinkov, ugotovljenih med uporabo Humire:
• injection site reactions (including pain, swelling, redness or itching).
Zelo pogosto (pri več kot 1 od 10 bolnikov): • reakcije na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo in srbenjem).
Common (in more than 1 in 100 patients but less than 1 in 10 patients): • lower respiratory tract infections (such as bronchitis, pneumonia); • upper respiratory tract infections (including cold, runny nose, sinus infection); • viral infections (including influenza, cold blisters and shingles); • bacterial infections (including urinary tract infection; • fungal infection • dizziness, vertigo, headache, sensation disorders; • cough, sore throat; • nausea, diarrhoea, abdominal pain, mouth inflammation and ulcers; • elevated liver enzymes; • rash, itching; • musculoskeletal pain; • fever, fatigue.
Pogosto (pri več kot 1 od 100 bolnikov, vendar manj kot pri 1 od 10 bolnikov): • okužbe spodnjih dihal (npr. bronhitis, pljučnica); • okužbe zgornjih dihal (vključno s prehladom, izcedkom iz nosu, okužbo obnosnih votlin); • virusne okužbe (vključno z gripo, ocvirki in pasovcem); • bakterijske okužbe (vključno z okužbami sečil); • glivične okužbe; • omotica, vrtoglavica, glavobol, motnje zaznavanja; • kašelj, vnetje žrela; • občutek siljenja na bruhanje, driska, bolečine v trebuhu, vnetje in razjede v ustih; • zvišanje jetrnih encimov; • izpuščaj, srbenje; • mišičnoskeletna bolečina; • povišana telesna temperatura, utrujenost.