natgillin/translations-raw huggingface dataset:
A hypersensitivity reaction (serious allergic reaction) has been reported in about 5 in every 100 patients who have been treated with abacavir.
Pri približno 4- 5 od vsakih 100 bolnikov, ki so se zdravili z abakavirjem, so poročali o pojavu preobčutljivostne reakcije (hude alergijske reakcije).
This is described in section 2 of this leaflet under “ Take special care with Trizivir”.
To je opisano v poglavju 2 tega navodila pod naslovom "Bodite posebno pozorni pri uporabi zdravila Trizivir".
Trizivir contains abacavir, lamivudine and zidovudine.
43 Zdravilo Trizivir vsebuje tri zdravilne učinkovine: abakavir, lamivudin in zidovudin.
The side effects listed below have been reported with one or more of these medicines and therefore may occur also when taking Trizivir Very common side effects (reported in greater than 10 out of 100 patients)
Zelo pogosti neželeni učinki (pri več kot 10 od 100 bolnikov):
− headache, nausea
− Glavobol, siljenje na bruhanje.
Common side effects (reported in 1 to 10 out of 100 patients)
Pogosti neželeni učinki (pri 1 do 10 od 100 bolnikov):
− anaemia (low red blood cell count) and neutropenia / leucopenia (low white blood cell count).
− Anemija (majhno število rdečih krvničk) in nevtropenija/ levkopenija (majhno število belih krvničk).
If the production of red blood cells is reduced you may have symptoms of tiredness or
Če je nastajanje rdečih krvničk zmanjšano, imate lahko simptome utrujenosti in zadihanosti.
A reduction in your white blood cell count can make you more prone to infection.
Znižanje števila belih krvničk lahko poveča vašo dovzetnost za okužbo.
Increase in enzymes produced by the liver. − tiredness, high temperature, dizziness, malaise, general feeling of being unwell, lethargy, difficulty in sleeping, joint pain, muscle disorders. − cough, nasal symptoms, (irritation, runny nose). − loss of appetite, vomiting, stomach pain and cramps, diarrhoea, − abacavir hypersensitivity, skin rash (without any other illness), hair loss.
Povečane vrednosti jetrnih encimov. − Utrujenost, povišana telesna temperatura, omotica, občutek slabosti, splošno slabo počutje, letargija (globokemu spanju podobno stanje), težave s spanjem, bolečine v sklepih, mišične motnje. − Kašelj, težave z nosom (draženje, izcedek). − Pomanjkanje apetita, bruhanje, krči in bolečine v trebuhu, driska. − Preobčutljivost za abakavir, kožni izpuščaj (brez drugih bolezenskih znakov), izpadanje las.
Uncommon side effects (reported in 1 to 10 out of 1000 patients)
Občasni neželeni učinki (pri 1 do 10 od 1000 bolnikov):
− Reduction in platelets (blood cells important for blood clotting) has been reported.
− Poročali so o zmanjšanju števila trombocitov (krvnih celic, pomembnih za strjevanje krvi).
If you have a low platelet count you may notice that you bruise more easily. − Breathlessness, flatulence, itching.
Če imate majhno število krvnih ploščic, boste morda opazili hitrejši nastanek modric. − Zasoplost, napenjanje, srbenje.
Rare side effects (reported in less than 1 in 1000 patients)
Redki neželeni učinki (pri manj kot 1 in 1000 bolnikov):
− anxiety, depression, drowsiness, convulsions (fits). − taste changes, patchy colour changes in the mouth, indigestion, inflammation of the pancreas, liver disorders such as enlarged liver, fatty liver, jaundice and inflammation (hepatitis), increase in an enzyme called amylase. − urinary frequency, enlargement of the breasts in men, chest pain may occur, possibly indicating a heart muscle disease called cardiomyopathy. numbness, tingling sensation or sensation of weakness in the limbs, breakdown of muscle tissue. − nail and skin colour changes, sweating, chills, flu-like symptoms.
− Tesnoba, depresija, zaspanost, konvulzije (krči). − Spremembe okušanja, lisaste spremembe na ustni sluznici, slaba prebava, vnetje trebušne slinavke, bolezni jeter, kot so povečana jetra, zamaščena jetra, zlatenica in vnetje jeter (hepatitis), povišana vrednost amilaze (encima). − Spremenjena pogostnost uriniranja, povečanje dojk pri moških, pojavijo se lahko bolečine v prsnem košu, kar morda kaže na obolenje srčne mišice, imenovano kardiomiopatija, otrplost, občutek zvenenja, občutek oslabelosti okončin, zmanjšnje mišične mase. − Spremembe obarvanja nohtov in kože, znojenje, mrazenje, gripi podobni bolezenski znaki.
Very rare side effects (reported in less than 1 in 10, 000 patients)
Zelo redki neželeni učinki (pri manj kot 1 in 10. 000 bolnikov):
− serious skin reactions, severe anaemia and neutropenia.
- Hude kožne reakcije, huda anemija in nevtropenija.
Cases of a condition called lactic acidosis, which is a build up of lactic acid in the body have been reported in some patients taking NRTIs (see “ Take special care with Trizivir” under section 2 for use for more information).
Pri nekaterih bolnikih, ki so jemali NRTI- je, so poročali o primerih stanja, imenovanega laktatacidoza, kar je nabiranje mlečne kisline v telesu (za več podatkov glejte "Bodite posebno pozorni pri uporabi zdravila Trizivir" v poglavju 2).
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck ('buffalo hump ').
To lahko vključuje izgubo maščevja na nogah, rokah in obrazu, nalaganje maščob v abdomnu (trebuh) in drugih notranjih organih, povečanje prsi in pojav maščobnih izboklin na zadnji strani vratu (bivolja grba).
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
Kombinirano zdravljenje s protiretrovirusnimi zdravili lahko povzroči tudi povišanje mlečne kisline in sladkorja v krvi, hiperlipidemijo (povišana količina maščob v krvi) in odpornost na insulin.
HOW TO STORE TRIZIVIR
SHRANJEVANJE ZDRAVILA TRIZIVIR
Do not use Trizivir after the expiry date which is stated on the packaging.
Shranjujte pri temperaturi do 30 °C.
The expiry date refers to the last day of that month.
Zdravila Trizivir ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
What Trizivir contains The active substances in each Trizivir film-coated tablet are 300 mg of abacavir (as sulfate), 150 mg lamivudine and 300 mg zidovudine.
300 mg abakavirja (v obliki sulfata), 150 mg lamivudina in 300 mg zidovudina.
The other ingredients are microcrystalline cellulose, sodium starch glycollate and magnesium stearate in the core of the tablet.
Pomožne snovi so: mikrokristalna celuloza, natrijev karboksimetilškrob in magnezijev stearat v jedru tablete.
What Trizivir looks like and contents of the pack The capsule-shaped film-coated tablets are blue/ green and engraved with ‘ GX LL1’ on one side.
Izgled zdravila Trizivir in vsebina pakiranja Filmsko obložene tablete imajo obliko kapsule, so modrozelene barve in imajo na eni strani odtisnjeno oznako ‘ GX LL1 ’.
They are provided in blister packs containing 60 tablets or bottles containing 60 tablets with child-resistant tops.
Na voljo so v pretisnih omotih, ki vsebujejo 60 tablet, ali v plastenkah z za otroke varnimi zaporkami, ki vsebujejo 60 tablet.
Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom
Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, Velika Britanija
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, UK
Glaxo Operations UK Ltd (trži Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, Velika Britanija
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
45 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 info. produkt@gsk. com
Sverige GlaxoSmithKline AB Tel: +46 (0) 8 638 93 00 info. produkt@ gsk. com
r of the EPAR).
lje Kaj je zdravilo Trudexa?
What is Trudexa? ge lon Trudexa is a medicine containing the active substance adalimumab.
Trudexa je zdravilo, ki vsebuje zdravilno učinkovino adalimumab.
It is available as a solution for injection in a vial, pre-filled syringe or pre-filled pen, all containing 40 mg of adalimumab.
Na voljo je kot raztopina za injiciranje v viali, napolnjeni injekcijski brizgi ali napolnjenem injekcijskem peresniku, vse oblike pa vo vsebujejo po 40 mg adalimumaba.
What is Trudexa used for? no
Za kaj se zdravilo Trudexa uporablja? do
It is used to treat adults with the following diseases: • rheumatoid arthritis (an immune system disease causing inflammation of the joints).
Uporablja se pri zdravljenju odraslih z naslednjimi boleznimi: • revmatoidnim artritisom (bolezen imunskega sistema, ki povzroča vnetje sklepov).
Trudexa is used in combination with methotrexate (a medicine that acts on the immune system) in patients with moderate or severe disease who have not responded adequately to other t
Zdravilo eā
treatments, or patients with severe disease who have not taken methotrexate before.
Trudexa se uporablja v povezavi z metotreksatom (zdravilom, ki vpliva na imunski sistem) pri bolnikih z zmerno ali hudo boleznijo, ki se ne odzivajo zadostno na druge oblike zdravljenj, ali pri bolnikih s hudo obliko bolezni, ki še niso prejemali metotreksata.
Trudexa uc
Zdravilo Trudexa se av
can be used alone if the patient cannot take methotrexate. • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) in patients who have not responded adequately to other treatments, rod
lahko uporablja samostojno pri bolnikih, ki ne prenašajo metotreksata; • psoriatičnim artritisom (bolezen, ki povzroča nastajanje rdečih in luskinastih zaplat na koži in vnetje sklepov) pri bolnikih, ki se niso ustrezno odzvali na druge oblike zdravljenj; • hudim ankilozirajočim spondilitisom (bolezen, k povzroča vnetje in bolečine sklepov nim
• severe ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine) in patients who have not responded adequately to other treatments.
hrbtenice) pri bolnikih, ki se niso ustrezno odzvali na druge oblike zdravljenj.
The medicine can only be obtained with a prescription. lP
Zdravilo se dobi samo na recept.
How is Trudexa used?
Kako se zdravilo Trudexa uporablja? ilo
treatment of the diseases that Trudexa is used to treat.
Zdravljenje z zdravilom Trudexa mora uvesti in nadzirati zdravnik z izkušnjami pri zdravljenju bolezni, ki se zdravijo s tem zdravilom.
Some patients with rheumatoid arthritis who are taking Trudexa without methotrexate may benefit from taking this dose i dic
Nekaterim bolnikom z revmatoidnim artritisom, ki rav
After training, patients may inject themselves with Trudexa if their doctor agrees.
prejemajo samo zdravilo Trudexa brez metotreksata, lahko koristi isti odmerek, apliciran enkrat na teden.
Me
Bolniki, ki prejemajo zdravilo Trudexa, morajo dobiti posebno opozorilno izkaznico, ki povzema Zd
How does Trudexa work?
varnostne podatke o zdravilu.
The active substance in Trudexa, adalimumab, is a monoclonal antibody.
Kako zdravilo Trudexa deluje?
Adalimumab has been designed to bind to a chemical messenger in the body called tumour necrosis factor (TNF).
Zdravilna učinkovina adalimumab v zdravilu Trudexa je monoklonsko protitelo.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Monoklonsko protitelo je vrsta protitelesa (vrsta beljakovine), ki je bilo zasnovano za prepoznavanje in vezanje na 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged and is found at high levels in patients with the diseases that Trudexa is used to treat.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged določeno strukturo (imenovano antigen), ki jo najdemo na določenih celicah telesa.
By blocking TNF, adalimumab improves the inflammation and other symptoms of the diseases.
Ta obveščevalna molekula sodeluje pri vnetjih in je prisotna v visokih koncentracijah pri bolnikih, ki jih zdravijo z zdravilom Trudexa.
How has Trudexa been studied?
t Kako je bilo zdravilo Trudexa raziskano?
Trudexa has been studied in five studies including almost 2,900 patients with moderate to severe rheumatoid arthritis.
me Zdravilo Trudexa so raziskovali v petih raziskavah, ki so vključevale skoraj 2900 bolnikov z zmernim do hudim revmatoidnim artritisom.
In four of these studies (involving over 2,000 patients), the effectiveness of
V štirih od teh raziskav (vključevale so več kot 2000 bolnikov) so učinkovitost zdravila Trudexa, ki so ga dajali samostojno ali kot dodatek zdravljenju z drugim
ed Trudexa, alone or as an as add-on to other anti-inflammatory medicines, including methotrexate, was compared with that of a placebo (a dummy treatment) in patients who generally had taken anti-arthritis medicines in the past.
pro protivnetnim zdravilom, vključno z metotreksatom, primerjali z učinkom placeba (zdravilom brez zdravilne učinkovine) pri bolnikih, ki so v preteklosti že prejemali zdravilo proti artritisu.
The fifth study included 799 patients, none of whom had taken methotrexate in
Peta raziskava je vključevala 799 bolnikov, ki v preteklosti še niso prejemali metotreksata, v raziskavi pa so primerjali kombinacijo zdravila Trudexa in metotreskata s samostojnim dajanjem metotreksata ali zdravila Trudexa.
ris the past, and compared the combination of Trudexa and methotrexate to methotrexate or Trudexa alone.
za po šestih mesecih do enega leta zdravljenja.
tho For psoriatic arthritis, Trudexa was compared to placebo in two studies including 413 patients.
V dveh raziskavah, ki sta vključevali 413 bolnikov s psoriatičnim artritisom, so zdravilo Trudexa primerjali s placebom.
For ankylosing spondylitis, Trudexa and placebo as an add-on to existing treatment were compared in two studies involving 397 patients.
V dveh raziskavah, ki sta vključevali 397 bolnikov z ankilozirajočim spondilitisom,
For both diseases, the patients had had an
nja so primerjali zdravilo Trudexa in placebo, ki so ju uporabili kot dodatka že obstoječemu zdravljenju.
au inadequate response to previous therapy, and the main measure of effectiveness was the change in symptoms after 12 weeks of treatment.
V primeru obeh bolezni so se bolniki pred tem neustrezno odzvali na prejšnje oblike zdravljenja, glavno merilo učinkovitosti pa je bila sprememba simptomov po 12 tednih zdravljenja. lje Kakšne koristi je zdravilo Trudexa izkazalo med raziskavami?
r What benefit has Trudexa shown during the studies?
V primeru revmatoidnega artritisa je bilo zdravilo Trudexa pri manjšanju jakosti simptomov bolj vo učinkovito kot placebo.
ge In rheumatoid arthritis, Trudexa was more effective than placebo in reducing symptoms.
Največja zmanjšanja so opazili pri raziskavah, v katerih so raziskovali zdravilo Trudexa kot dodatek zdravljenju z metotreksatom: v dveh raziskavah skupaj sta po šestih mesecih približno dve tretjini bolnikov, ki so kot dodatno zdravljenje prejemali 40 mg zdravila do
The greatest reductions were seen in the studies examining Trudexa as an add-on to methotrexate: in the two studies taken together, around two thirds of the patients adding 40 mg Trudexa every 2 weeks had at lon least a 20% reduction in symptoms after 6 months, compared to a quarter of those adding placebo.
Trudexa vsake dva tedna, pokazali 20% zmanjšanje jakosti simptomov, v primerjavi s četrtino tistih bolnikov, ki so kot dodatek prejemali placebo.
In the patients who had not taken methotrexate before, more patients taking Trudexa and methotrexate had a 50% reduction in symptoms than those taking methotrexate alone over a year of treatment (62% and 46%, respectively). no
Pri bolnikih, ki predhodno še niso prejemali metotreksata, je 50% eā
For the other two diseases, Trudexa produced a greater improvement in symptoms than placebo.
zmanjšanje jakosti simptomov po enem letu zdravljenja pokazalo več bolnikov, ki so prejemali zdravili Trudexa in metotrexat, kot tistih, ki so jemali samo metotreksat (62% oziroma 46%).
In studies of Trudexa, the most common side effects (seen in more than 1 patient in 10) were upper t uc
V raziskavah zdravila Trudexa so bili najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) vnetje zgornjih dihal (prehladi) in reakcije na mestu vbrizganja (vključno z bolečino, otekanjem, nim
respiratory infection (colds) and injection site reactions (including pain, swelling, redness or pruritus [itching]).
Zaradi povečanega tveganja okužbe je treba med zdravljenjem z zdravilom Trudexa in do pet mesecev po zaključku le- tega bolnike skrbno opazovati zaradi morebitnih okužb, ki vključujejo tudi tuberkulozo.
Due to an increased risk of infection, patients must be monitored closely for infections, including tuberculosis, during and for up to 5 months after treatment with Trudexa.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Trudexa, glejte Navodilo za uporabo.
For the full list of rod
Zdravila Trudexa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) ilo
Trudexa should not be used in people who may be hypersensitive (allergic) to adalimumab or any of the other ingredients.
adalimumab ali katerokoli drugo sestavino zdravila.
Trudexa should not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure. lP
Zdravila Trudexa se ne sme uporabljati pri bolnikih s tuberkulozo, drugimi hudimi boleznimi ali zmerno do hudim popuščanjem srca. rav
The Committee for Medicinal products for Human Use (CHMP) decided that Trudexa’ s benefits are na
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so koristni učinki zdravila Trudexa večji od z njim povezanih tveganj pri zdravljenju zmernega do hudega revmatoidnega artritisa, psoriatičnega artritisa in ankilozirajočega spondilitisa pri odraslih, če se druge oblike Zd
greater than its risks for treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in adults when other treatments have been inadequate.
zdravljenja niso izkazale za primerne.
The committee recommended that Trudexa i dic
Odbor je zato priporočil odobritev dovoljenja za promet z zdravilom Trudexa.
be given marketing authorisation.
Druge informacije o zdravilu Trudexa:
Other information about Trudexa:
©EMEA 2007
The European Commission granted a marketing authorisation valid throughout the European Union Me
2/ 3
for Trudexa to Abbott Laboratories Ltd. on 1 September 2003.
Evropska komisija je dovoljenje za promet z zdravilom Trudexa, veljavno po vsej Evropski uniji, odobrila družbi Abbott Laboratories Ltd. dne 1. septembra 2003.
This summary was last updated in 03-2007.
pro za nja lje vo do eā av nim ilo rav Zd
d EU Number
t e Številka EU
Invented
Izmišljeno ime Jakost
Package size
Vsebina (koncentracija)
40 mg
40 mg Raztopina za
1 vial + 1 syringe +
1 viala +
ho 2 alcohol pads
1 injekcijska brizga + 2 alkoholna zloženca
t EU/ 1/ 03/ 257/ 002
p EU/ 1/ 03/ 257/ 002
Subcutaneous
Subkutana uporaba
pre-filled
Napolnjena injekcijska brizga (steklo)
1 alcohol pad
1 napolnjena injekcijska brizga +
EU/ 1/ 03/ 257/ 003
za 1 alkoholni zloženec EU/ 1/ 03/ 257/ 003
2 alcohol pads
2 napolnjeni injekcijski brizgi +
r EU/ 1/ 03/ 257/ 004
ja 2 alkoholna zloženca EU/ 1/ 03/ 257/ 004
4 pre-filled syringes +
4 napolnjene injekcijske
ge
en
syringe (glass)
brizga (steklo)
4 alcohol pads
brizge +
EU/ 1/ 03/ 257/ 005
lj 4 alkoholni zloženci EU/ 1/ 03/ 257/ 005
6 pre-filled syringes +
6 napolnjenih injekcijskih
on
vo
6 alcohol pads
brizg + 6 alkoholnih zložencev
l EU/ 1/ 03/ 257/ 006
o EU/ 1/ 03/ 257/ 006
1 pre-filled syringe with needleguard +
1 napolnjena injekcijska brizga s ščitnikom za iglo +
no 1 alcohol pad
d 1 alkoholni zloženec
ct EMEA Number
eā v Številka postopka EMEA
Strength
Izmišljeno ime Jakost
d EMEA/ H/ C/ 000482/ II/ 0030/
a EMEA/ H/ C/ 000482/ II/ 0030/ 007
40 mg
40 mg Raztopina za injiciranje
pre-filled pen
Napolnjen injekcijski peresnik (steklo)
1 pre-filled pen + 1
1 napolnjen injekcijski peresnik +
alcohol pad in a blister
im 1 alkoholni zloženec
EMEA/ H/ C/ 000482/ II/ 0030/
n EMEA/ H/ C/ 000482/ II/ 0030/ 008
2 pre-filled pens + 2
2 napolnjena injekcijska peresnika +
l EMEA/ H/ C/ 000482/ II/ 0030/
ilo 2 alkoholna zloženca EMEA/ H/ C/ 000482/ II/ 0030/ 009
pre-filled pen
Napolnjen injekcijski
4 pre-filled pens + 4
4 napolnjeni injekcijski
na 009
v
(glass)
peresnik (steklo)
alcohol pads in a blister
peresniki +
EMEA/ H/ C/ 000482/ II/ 0030/
ra 4 alkoholni zloženci EMEA/ H/ C/ 000482/ II/ 0030/ 010
6 pre-filled pens + 6
6 napolnjenih injekcijskih
i
d
alcohol pads in a blister
peresnikov + 6 alkoholnih zložencev
ed M 1/ 1
Z 1/ 1
SUMMARY OF PRODUCT CHARACTERISTICS t no uc rod lP nai dic Me
t me pro za nja lje DODATEK I vo POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA do eā av nim ilo rav Zd
ed Each 0.8 ml single dose vial contains 40 mg of adalimumab.
t me Ena 0, 8 ml viala z enim odmerkom vsebuje 40 mg adalimumaba.
Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells.
Adalimumab je rekombinantno humano monoklonsko protitelo, pridobljeno v celicah jajčnika
ris For a full list of excipients, see section 6.1.
pro kitajskega hrčka.
tho 3.
za 3.
au 4.
nja 4.
r 4.1 Therapeutic indications
lje 4. 1 Terapevtske indikacije
ge Rheumatoid arthritis lon Trudexa in combination with methotrexate, is indicated for:
Revmatoidni artritis vo Trudexa je v kombinaciji z metotreksatom indicirana za: do
the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been no
Zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča zdravila, vključno z metotreksatom, ni zadosten.
inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. t
Zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še eā
Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued uc
Trudexo je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljne av
treatment with methotrexate is inappropriate.
zdravljenje z metotreksatom ni primerno.
Trudexa has been shown to reduce the rate of progression of joint damage as measured by X-ray and rod
Dokazano je, da Trudexa upočasni napredovanje rentgenografsko merjene prizadetosti sklepov in nim
to improve physical function, when given in combination with methotrexate.
izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
Psoriatic arthritis lP
Psoriatični artritis
Trudexa is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. na
Trudexa je indicirana za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen. ilo
Ankylosing spondylitis
Ankilozirajoči spondilitis rav
Trudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have i
Zd
Crohn’ s disease Me
Crohnova bolezen
Trudexa is indicated for treatment of severe, active Crohn’ s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/ or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Trudexa je indicirana za zdravljenje hude, aktivne Crohnove bolezni pri bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.