natgillin/translations-raw huggingface dataset:
• anaemia, low white blood cell counts; • allergic reactions; • increased lipid values, appetite disorders; • lP
pro • resne okužbe (npr. sepsa [zastrupitev krvi]), okužba sklepa, glivične okužbe; • bradavica na koži; • anemija, zmanjšanje števila belih krvnih celic; • alergijske reakcije; • zvišani lipidi, motnje apetita;
anxiety, depression, feeling sleepy and difficulty sleeping; • nerve disorders (such as multiple sclerosis and eye nerve inflammation), taste disturbances; • vision disturbances; • na
za • tesnobnost, depresija, zaspanost in težave s spanjem; • bolezni živčevja (npr. multipla skleroza in vnetje očesnega živca), motnje okusa, motnje vida; • neprijeten občutek v ušesu;
• skin disorders (such as psoriasis, eczema or infections), itchy rash, slow wound healing; • muscle weakness; • urinary disturbances (such as blood in urine, increased urinary frequency); Me
nja • občutek hitrega bitja srca, visok krvni pritisk; • astma, hitra zadihanost; • trebušni simptomi (npr. bruhanje, prebavne težave, zaprtje), krvavitve v danko; • bolezni kože (npr. luskavica, ekcem ali okužbe), srbeč izpuščaj, počasno celjenje ran; lje • mišična šibkost; • motnje na sečilih (npr. kri v urinu, pogostejše uriniranje); vo • močnejše menstruacijske krvavitve; • simptomi podobni gripi, bolečine v prsih, otekanje stopal. do
• increased menstrual bleeding; • flu like symptoms, chest pain, swelling of the feet.
Redko (≥1/ 10. 000 do < 1/ 1. 000) • gavkom • kožni rak • bolezni ščitnice eā
Rare (< 1/ 1000) • glaucoma; • skin cancer; • thyroid disorders;
• beljakovine v urinu
138 • protein in urine.
Drugi neželeni učinki, zabeleženi pri bolnikih, ki so jemali Trudexo: av
Other side effects that have been observed in patients taking Trudexa: tuberculosis and other opportunistic infections (infections that occur when resistance to disease is lowered); lung disease.
tuberkuloza in druge oportunistične okužbe (okužbe, ki se pojavijo, kadar se zmanjša odpornost proti boleznim); pljučna bolezen. nim
ed If any side effects get serious, if you have any unusual effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželen učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE TRUDEXA
SHRANJEVANJE ZDRAVILA TRUDEXA ilo
tho Keep out of the reach and sight of children.
Zdravilo shranjujte nedosegljivo otrokom! rav
Do not use the Trudexa pre-filled syringe after the expiry date stated on the label/ blister/ carton after
Zdravila Trudexa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/ pretisnem omotu/ škatli za “ Uporabno do: ”.
The expiry date refers to the last day of that month.
Zd
Trudexa 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg lon adalimumab dissolved in 0.8 ml solution.
138 Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi je na voljo kot sterilna raztopina 40 mg adalimumaba, raztopljenega v 0, 8 ml raztopine.
What Trudexa contains no
Kaj vsebuje zdravilo Trudexa
The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections. t uc
t Pomožne snovi so manitol, citronska kislina monohidrat, natrijev citrat, natrijev dihidrogenfosfat
What the Trudexa pre-filled syringe looks like and contents of the pack rod
me dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid, polisorbat 80, natrijev hidroksid in voda za injekcije.
Not all pack sizes may be marketed. lP
Na trgu ni vseh navedenih pakiranj.
Trudexa is also available as a vial or a pre-filled pen.
za Trudexa je na voljo tudi v vialah in kot napolnjen injekcijski peresnik.
Marketing Authorisation Holder: na
Imetnik dovoljenja za promet
Abbott Laboratories Ltd Queenborough Kent ME11 5EL i dic
nja Abbott Laboratories Ltd Queenborough lje Kent ME11 5EL Velika Britanija vo Izdelovalec
Me
Abbott Biotechnology Deutschland GmBH do
Abbott Biotechnology Deutschland GmbH Max-Planck-Ring 2 D - 65205 Wiesbaden Germany
Max- Planck- Ring 2 D- 65205 Wiesbaden Nemčija eā
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom. av
139 België/ Belgique/ Belgien Abbott SA Parc Scientifique Rue du Bosquet, 2 B-1348 Ottignies/ Louvain-la-Neuve
België/ Belgique/ Belgien Abbott SA Parc Scientifique nim
Luxembourg/ Luxemburg Abbott SA Parc Scientifique Rue du Bosquet, 2 B-1348 Ottignies/ Louvain-la-Neuve
Luxembourg/ Luxemburg Abbott SA Parc Scientifique
ed Tél/ Tel: + 32 10 475311
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Belgique/ Belgien Tél/ Tel: + 32 10 475311
Rue du Bosquet, 2 B- 1348 Ottignies/ Louvain- la- Neuve Belgique/ Belgien Tél/ Tel: + 32 10 475311
ris България Т .П.
България ilo
Оборище № 45
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tho София 1504 Teл.: + 359 2 846 8429
София 1504 Teл.: + 359 2 846 8429
Č eská republika
Česká republika Zd
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Avenida de Burgos, 91 E- 28050 Madrid Tel: + 34 9 1 337- 5200 eā
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ed Abbott Laboratories, Ireland, Ltd 4051 Kingswood Drive Citywest Business Campus
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nja Lietuva Abbott LaboratoriesBaltics Vienibas 87h lje LV- 1004 Rīga Latvia Tel: + 371 7605580 vo do
This leaflet was last approved in {MM/YYYY} Me
Navodilo je bilo odobreno {MM/ LLLL} eā av nim ilo rav Zd
Trudexa 40 mg solution for injection in pre-fill ed syringe with needleguard Adalimumab
Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom za iglo adalimumab
ed Read all of this leaflet carefully before you start using this medicine. − Keep this leaflet.
t Pred uporabo natančno preberite navodilo!
ris information that you need to be aware of before you are given Trudexa and during treatment with Trudexa.
informacije, s katerimi morate biti seznanjeni, preden prejmete Trudexo in med zdravljenjem z
Keep this Patient Alert Card with the package leaflet. − If you have any further questions, please ask your doctor or pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Če katerikoli neželen učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
(tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. rod
Adalimumab se veže na specifično beljakovino (tumorje nekrotizirajoči faktor ali TNFα), ki je pri vnetnih boleznih, kakršne so revmatoidni artritis, psoriatični artritis in ankilozirajoči spondilitis, prisoten v večji koncentraciji. av
Rheumatoid arthritis
Revmatoidni artritis nim
If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate. lP
Če imate zmeren do hud aktiven revmatoidni artritis, boste morda najprej dobili druga imunomodulirajoča zdravila, npr. metotreksat.
If your doctor determines that methotrexate is Me
Zd
142 Ankylosing spondylitis
142 Ankilozirajoči spondilitis je vnetna bolezen hrbtenice.
If you do not respond well enough to these m edicines, you will be given Trudexa 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 Trudexo.
ed Crohn’s disease
Crohnova bolezen
ris Crohn’s disease is an inflammatory disease of the digestive tract.
t 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
• If you a re allergic (hypersensitive) to adalimumab or any of the other ingredients of Trudexa.
za • če ste alergični na (preobčutlji za) adalimumab ali katerokoli sestavino zdravila Trudexa.
r • If you have a severe infection, including active tuberculosis (see “Take special care with
• če imate hudo okužbo, vključno z aktivno tuberkulozo (glejte "Bodite posebno pozorni pri uporabi Trudexe").
It is important that you tell your doc tor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems. lon • If you have moderate or severe heart failure.
nja 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 Trudexa”).
Pomembno je, da zdravniku poveste, če ste imeli ali lje imate kakšno resno bolezen srca (glejte "Bodite posebno pozorni pri uporabi Trudexe").
Take special care with Trudexa: no
Bodite posebno pozorni pri uporabi Trudexe vo • Če doživite alergijske reakcije, npr.
• If you experience allergic reactions s uch as chest tightness, wheezing, dizziness, swelling or rash do not inject more Trudexa and contact your doctor immediately. t
Tiščanje v prsih, piskajoče dihanje, omotico, otekanje ali izpuščaj, Trudexe ne injicirajte več in se takoj posvetujte s svojim zdravnikom. do
Patients who have a known sensitivity to latex should be advised to avoid touching the inner shield. rod
Bolnikom z znano občutljivostjo za lateks je treba eā
If you are unsure, please contact your doctor. lP
naročiti, da se ne smejo dotikati notranjega ščitnika.
It is important to tell your doctor if you get symptoms such as fever, wounds, na
• Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se av
feeling tired or dental problems.
Če niste gotovi, se posvetujte s svojim zdravnikom.
• As cases of tuberculosis have been reported in patients treated with Trudexa, your doctor will i
• Med zdravljenjem s Trudexo se lahko poveča dovzetnost za okužbe, vključno z resnimi nim
check you for signs and symptoms of tuberculosis before starting Trudexa.
okužbami, tuberkulozo, oportunističnimi okužbami in sepso, ki so lahko v redkih primerih smrtno nevarne.
This will include a dic
Pomembno je, da zdravniku poveste, če doživite simptome, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali težave z zobmi.
thorough medical history, a chest X-ray and a tuberculin test.
• Ker so bili pri bolnikih, zdravljenih s Trudexo, opisani primeri tuberkuloze, vas bo zdravnik ilo
The conduct of these tests should be recorded on your Patient Alert Card.
pred začetkom zdravljenja s Trudexo preiskal glede znakov in simptomov tuberkuloze.
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 Me
To bo vključevalo natančno poizvedbo o vašem zdravju v preteklosti, rentgensko slikanje prsnih organov in tuberkulinski test.
tuberculosis.
Zelo pomembno je, da zdravniku poveste, če ste kadarkoli imeli tuberkulozo ali ste bili v tesnem stiku s kom, ki jo je imel.
Trudexa can cause reactivation of 143 HBV in people who carry this virus.
143 tega virusa.
• If you are about to undergo surgery or dental proc edures please inform your doctor that you are taking Trudexa.
• Če boste imeli kirurški poseg ali poseg na zobeh, prosimo, povejte svojemu zdravniku, da jemljete Trudexo.
ed • If you have multiple sclerosis, your doctor will decide if you should receive Trudexa
me Če imate multiplo sklerozo, bo zdravnik presodil, ali lahko dobivate Trudexo.
Your
Ta bo
au doctor will decide if you should receive Trudexa.
za presodil, ali lahko dobivate Trudexo.
• In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding.
• Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic, ki pomagajo pri premagovanju okužbe
If you develop a feve r that does not go away,
nja ali ustavitvi krvavitve.
Your doctor may
Če dobite zvišano telesno temperaturo, ki ne mine, če se vam pojavljajo podplutbe, zlahka zakrvavite ali ste zelo bledi, se takoj posvetujte s svojim zdravnikom.
• There have been very rare cases of certain kinds of cancer in patients taking Trudexa or other lon TNF blockers.
Morda se bo odločil, da vaše zdravljenje prekine. lje • Med bolniki, ki so jemali Trudexo ali druge zaviralce TNF, so se pojavili zelo redki primeri določenih vrst raka.
If you take Trudexa your risk may increase.
Če vo jemljete Trudexo, se ta verjetnost poveča.
In addition very rare cases of non-melanoma skin cancer have been observed in patients taking Trudexa. no
Poleg tega so pri bolnikih, zdravljenih s Trudexo, opazili zelo redke primere nemelanomskega kožnega raka. do
• Cancers, other than lymphoma, have been reported 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), zdravljenim z nekim drugim zaviralcem TNF, so poročali o rakih, ki niso bili limfomi.
If you have COPD, or are a heavy smoker, you should discuss with your doctor t
Če imate KOPB ali če veliko kadite, se morate z zdravnikom posvetovati, ali je zdravljenje z zaviralcem eā
whether treatment with a TNF blocker is appropriate for you. uc
TNF za vas primerno.
Using other medicines rod
Uporaba drugih zdravil av
Trudexa 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. lP
Trudexo 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. nim
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. na
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
If you have questions, please ask your doctor. i
Če imate vprašanja, se ilo
Using Trudexa with food and drink dic
Uporaba zdravila Trudexa skupaj s hrano in pijačo rav
Me
Ker se Trudexa uporablja subkutano, hrana in pijača naj ne bi vplivali na Trudexo.
Pregnancy and breast-feeding
Nosečnost in dojenje Zd
144 If you are a breast-feeding mother, advise you should stop breast-feeding during Trudexa treatment, and for at least 5 months after the last Trudexa treatment.
144 Če dojite, morate dojenje med zdravljenjem s Trudexo prekiniti in ne smete dojiti vsaj še 5 mesecev po zadnjem odmerku Trudexe.
Trudexa should not affect your ability to drive or use machinery.
t Trudexa naj ne bi vplivala na vašo sposobnost upravljanja vozil in strojev.
ed Important information about some of the ingredients of Trudexa
me Pomembne informacije o nekaterih sestavinah zdravila Trudexa
ris This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.
pro To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) v odmerku, kar pomeni, da je količina zanemarljiva.
Trudexa is injected under the skin (subcutaneous use).
nja Trudexa se injicira pod kožo (subkutana uporaba).
The usual dose fo r adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab given every other week as
Običajni odmerek za odrasle z revmatoidnim artritisom, psoriatičnim artritisom in ankilozirajočim spondilitisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku.
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, lje 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 lon week.
Kadar je potreben hitrejši odziv, vam zdravnik lahko predpiše odmerek 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.
Depending on your response, your doctor may increase the dose to 40 mg every week.
Odvisno od vašega odziva vo lahko zdravnik poveča odmerek na 40 mg vsak drugi teden.
You should continue to inject Trudexa for as long as your doctor has told you.
Trudexo je treba injicirati toliko časa, kolikor vam je naročil zdravnik. do
If your doctor determines that no
Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko Trudexo dobivate samo.
methotrexate is inappropriate, Trudexa can be given alone.
Če imate revmatoidni artritis in če hkrati s Trudexo ne dobivate metotreksata, vam bo zdravnik morda eā
If you have rheumatoid arthritis and you do not receive methotrexate with your Trudexa therapy, your doctor may decide to give 40 mg adalimumab every week. t uc
predpisal 40 mg adalimumaba vsak teden.
Instructions for preparing and giving an injection of Trudexa:
Navodila za pripravo in injiciranje Trudexe av
follow them step by step.
Navodila natančno preberite in jih upoštevajte korak za korakom.
You will be instructed by your doctor or his/her assistant on the technique of self-injection.
Ne nim
Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
poskušajte si zdravila injicirati, dokler popolnoma ne obvladate priprave in dajanja injekcije.
After proper training, the injection can be self-administered or given by another person, for example a family member or friend. lP
Po ustreznem urjenju si lahko injekcije dajete sami ali vam jih daje kdo drug, npr. svojec ali prijatelj.
This injection should not be mixed in the same syringe or vial with any other medicine.
Raztopine ne smete v isti brizgi ali viali mešati z nobenim drugim zdravilom. ilo
1) Setting up na
1) Priprava
• Wash your hands thoroughly • Set up the following items on a clean surface i dic
• Na čisto površino pripravite naslednje:
145 ed ris tho • Look at the expiry date on the syringe.
145 t me pro • Preverite datum izteka roka uporabnosti na brizgi.
2) Choosing and preparing an injection site
za 2) Izbira in priprava injekcijskega mesta
au • Choose a site on you r thigh or stomach
• Izberite mesto na stegnu ali trebuhu.
r ge lon no
nja lje vo do
• Each new injecti on should be given at least 3 cm from the last injection site.
• Vsako naslednjo injekcijo morate dati vsaj 3 cm od mesta prejšnje injekcije.
This may mean there is an infecti on.
Te spremembe lahko pomenijo eā
Wipe the injection site with the enclosed alcohol pad, using a circular motion. t
gibom obrišite injekcijsko mesto s priloženim alkoholnim zložencem. av
D o not touch the area again before injecting. uc
Predela se pred injiciranjem ne dotikajte več.
3) Injecting Trudexa rod
3) Injiciranje Trudexe nim
• Do NOT shake the syringe. • Remove cap from needle syringe, being careful not to touch the needle or let it touch any surface. lP
• Brizge NE STRESAJTE. • Odstranite pokrovček z igle na brizgi; pazite, da se igle pri tem ne dotaknete in da se z njo česa ne dotaknete. • Z eno roko obzirno primite očiščeni predel kože in ga trdno držite. ilo rav Zd
• With one hand, gently grasp the cleaned areas of skin and hold firmly i na dic Me
146 • Z drugo roko držite brizgo pod kotom 45 stopinj na kožo, z užlebljenim delom obrnjenim navzgor. • S hitrim, kratkim gibom iglo v celoti zabodite v kožo. • Spustite kožo s prvo roko. • Potisnite bat, da boste injicirali raztopino – za izpraznitev brizge utegne biti potrebnih od 2 do 5 sekund.
• With the other hand, hold syringe at 45-degree angle to skin, with the grooved side up. • 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
Pri tem pazite, da jo boste držali pod enakim kotom, pod katerim ste jo zabodli. • Z eno roko držite brizgo, z drugo pa potegnite zunanji ščitnik čez razgaljeno iglo, dokler se ne zaskoči.
146 • When the syringe is empty, remove the needle from skin, being careful to keep it at the same angle as when it was inserted • Hold the syringe in one hand and with the other hand slide the outer protective shield over the exposed needle until it locks in place • Using your thumb or a piece of gauze, apply pressure over the injection site for 10 seconds.
pro • S palcem ali koščkom gaze 10 sekund pritiskajte na injekcijsko mesto.
ed 4) Throwing away supplies
4) Kako zavreči ostanke
ris • The Trudexa syringe should NEVER be reused.
za • Brizge s Trudexo NIKDAR ne smete ponovno uporabiti.
NEVER recap a needle • After injecting Trudexa, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
NIKDAR ne nameščajte pokrovčka nazaj na iglo. • Po injiciranju Trudexe porabljeno brizgo takoj zavrzite v poseben vsebnik, kot vam je naročil
tho • Keep this container out of the reach and sight of children
nja zdravnik, medicinska sestra ali farmacevt. • Ta vsebnik shranjujte nedosegljivo otrokom.