natgillin/translations-raw huggingface dataset:
• Dispose of the pen in a sharps container or as directed by your doctor, pharmacist or nurse.
• Brizgo zavrzite v zbiralnik za ostre predmete oziroma po navodilih zdravnika, farmacevta ali medicinske sestre.
Twist-off base cap
Odstotno izboljšanje PASI od izhodišča
Instructions for use Taltz 80 mg solution for injection in pre-filled pen
Navodila za uporabo Taltz 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku iksekizumab
Grey syringe plunger
Sivi bat sec
1 ml solution in a type I clear glass syringe.
1 ml raztopine v brizgi iz prozornega stekla tipa I. Brizga je vstavljena v enoodmerni peresnik za enkratno uporabo.
Table 4.
Preglednica 4
- hives.
- ekcem,
You may have slight bleeding.
Morda bo iz mesta injiciranja priteklo nekaj kapelj krvi.
Taltz 80 mg injection ixekizumab Subcutaneous use
IME ZDRAVILA IN POT(I) UPORABE Taltz 80 mg raztopina za injiciranje iksekizumab subkutana uporaba
Talk to your doctor, nurse or pharmacist before using Taltz:
Pred začetkom uporabe zdravila Taltz se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom: - če imate trenutno okužbo ali če imate dolgotrajne ali ponavljajoče se okužbe.
97 (49.7)a 127 (57.5)a
97 (49,7)a 127 (57,5)a 48,2 (40,9; Razlaga kratic: N = število bolnikov v populaciji za analizo
The pre-filled pen is for single use only.
Napolnjeni injekcijski peresnik je namenjen samo za enkratno uporabo.
The solution/the syringe must not be shaken.
Raztopine/injekcijske brizge ne smete stresati.
The medicine usually starts to have an effect after four to six weeks.
Zdravilo navadno prične učinkovati po štirih do šestih tednih.
What are the benefits and risks of Repso?
Kakšne so koristi in tveganja, povezani z zdravilom Repso?
The full EPAR for Repso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Repso je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It is available as tablets (white and round: 10 mg; dark beige and triangular: 20 mg).
Na voljo je v obliki okroglih tablet (belih in okroglih: 10 mg; temno bež in trikotnih: 20 mg).
This means that Repso is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Arava.
For more information about treatment with Repso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Repso preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Priporočeni vzdrževalni odmerek je 10 do 20 mg enkrat na dan za bolnike z revmatoidnim artritisom in 20 mg enkrat na dan za bolnike s psoriatičnim artritisom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Repso.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Repso, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Its effect may improve further for up to six months.
Učinki zdravila se lahko nato v nadaljnjih šestih mesecih še izboljšajo.
Repso is a ‘generic medicine'.
Zdravilo Repso je „generično zdravilo“.
Repso treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Zdravljenje z zdravilom Repso se začne z začetnim odmerkom 100 mg enkrat na dan prve tri dni, čemur sledi vzdrževalni odmerek.
Because Repso is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Repso generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
This is a summary of the European public assessment report (EPAR) for Repso.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Repso.
Repso is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Zdravilo Repso se uporablja za zdravljenje odraslih z aktivnim revmatoidnim artritisom (boleznijo imunskega sistema, ki povzroča vnetje sklepov) ali aktivnim psoriatičnim artritisom (boleznijo, ki povzroča rdeče in luskinaste zaplate na koži ter vnetje sklepov).
Repso treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Zdravljenje z zdravilom Repso mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem revmatoidnega artritisa in psoriatičnega artritisa.
With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
Zaradi manjšega števila prisotnih limfocitov je manjše tudi vnetje, kar pomaga pri obvladovanju simptomov artritisa.
Therefore, the CHMP's view was that, as for Arava, the benefit outweighs the identified risk.
Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Arava, odtehtajo znana tveganja.
Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Leflunomid to doseže z zaviranjem encima, imenovanega „dihidroorotatdehidrogenaza“, ki je potreben za razmnoževanje limfocitov.
The European Commission granted a marketing authorisation valid throughout the European Union for Repso to TEVA Pharma B.V. on 14 March 2011.
Evropska komisija je dovoljenje za promet z zdravilom Repso, veljavno po vsej Evropski uniji, odobrila družbi TEVA Pharma B.V.
Because Repso is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Ker je zdravilo Respo generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Arava.
The Committee recommended that Repso be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Repso odobri dovoljenje za promet.
The CHMP concluded that, in accordance with EU requirements, Repso has been shown to have comparable quality and to be bioequivalent to Arava.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Repso primerljivo raven kakovosti kot zdravilo Arava ter da mu je biološko enakovredno.
Repso is a medicine that contains the active substance leflunomide.
Repso je zdravilo, ki vsebuje zdravilno učinkovino leflunomid.
It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Zdravilo zmanjšuje vnetje tako, da zmanjša tvorjenje imunskih celic, imenovanih „limfociti“, ki povzročajo vnetje.
Why has Repso been approved?
Zakaj je bilo zdravilo Repso odobreno?
How has Repso been studied?
Kako je bilo zdravilo Repso raziskano?
The active substance in Repso, leflunomide, is an immunosuppressant.
Zdravilna učinkovina v zdravilu Respo, leflunomid, je sredstvo za zaviranje imunske odzivnosti.
What is Repso used for?
Za kaj se zdravilo Repso uporablja?
How is Repso used?
Kako se zdravilo Repso uporablja?
The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Repso, and regularly during treatment.
Zdravnik mora, preden predpiše zdravilo Repso in nato v rednih intervalih med zdravljenjem, opraviti krvne preiskave, s katerimi preveri delovanje bolnikovih jeter ter število belih krvnih celic in krvnih ploščic, .
What is Repso?
Kaj je zdravilo Repso?
Other information about Repso
Druge informacije o zdravilu Respo:
These studies included nearly 2,500 patients, of whom over 1,400 received valproate.
Te študije so vključevale skoraj 2 500 bolnikov, izmed katerih jih je več kot 1 400 prejemalo valproat.
In addition there is a considerable risk due to the narrow therapeutic window of this substance.
Poleg tega je prisotno precejšnje tveganje zaradi ozkega terapevtskega okna te snovi.
Method and duration of administration:
Način in trajanje uporabe:
4.1 Therapeutic indications
4.1 TERAPEVTSKE INDIKACIJE
1.1 Mania
1.1 Manija
1.2 Prevention of Recurrence of mood episodes
1.2 Preprečevanje ponovitev razpoloženjskih epizod
Anticonvulsants are increasingly becoming an alternative.
Antikonvulzivi se čedalje pogosteje uporabljajo kot nadomestna možnost.
In adults:
Pri odraslih:
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for <active substance>.
Mehanizem tega tveganja ni znan, razpoložljivi podatki pa ne izključujejo možnosti povečanega tveganja pri <zdravilni učinkovini>.
If at any time you have these thoughts, immediately contact your doctor.
Če imate take misli, se takoj posvetujte z zdravnikom.
Post-hoc analyses were done of the large Bowden study.
Naknadne analize so temeljile na obsežni Bowdenovi študiji.
The prolonged-release tablets should preferably be taken 1 hour before meals (on an empty stomach in the morning).
Najbolje je, da se tablete s podaljšanim sproščanjem vzamejo eno uro pred obrokom (zjutraj na prazen želodec).
The two recurrence prevention studies are of sufficient duration and have an active comparator as requested by European guidelines.
Obe študiji preprečevanja ponovitev sta trajali dovolj dolgo in vključujeta aktivno primerjalno zdravilo, kot to zahtevajo evropske smernice.
Patients receiving daily doses higher than 45mg/kg/day body weight should be carefully monitored.
Bolnike, ki prejemajo dnevne odmerke, večje od 45 mg/kg telesne mase/dan, je treba skrbno spremljati.
Please follow his/her instructions, otherwise you will not fully benefit from your medicine.
Upoštevajte zdravnikova navodila, sicer ne boste v celoti uživali prednosti tega zdravila.
2.2 Risk Management Plan
2.2 Načrt za obvladovanje tveganja
Valproic acid passes into the breast milk.
Valprojska kislina prehaja v materino mleko.
Based on the submitted data it cannot be concluded, that efficacy of valproate in the claimed indication is dependent on chemical form or formulation.
Na podlagi predloženih podatkov ni mogoče zaključiti, da je učinkovitost valproata pri predlagani indikaciji odvisna od kemijske oblike ali formulacije.
Although the pathogenesis of bipolar disorder is unclear, it is known that mood stabilizers, such as valproate, can prevent its recurrence.
Čeprav patogeneza bipolarne motnje ni jasna, je znano, da lahko stabilizatorji razpoloženja, kot je valproat, preprečijo njeno ponovitev.
The duration of treatment is determined by the treating doctor.
Trajanje zdravljenja določi lečeči zdravnik.
WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR {Invented name} is a medicine for the treatment of […] and mania.
KAJ JE ZDRAVILO {LASTNIŠKO IME} IN ZA KAJ GA UPORABLJAMO {Lastniško ime} je zdravilo za zdravljenje […] in manije.
Antiepileptic therapy is always a long-term therapy.
Antiepileptično zdravljenje je vedno dolgotrajno.
Your doctor will determine the exact dose required on an individual basis.
Vaš zdravnik bo natančni odmerek ugotovil na individualni podlagi.
However one study is lacking a short placebo arm, which is a deficiency and brings doubts about the validity of the results.
Vendar pa v eni študiji ni bila prisotna kratkoročna skupina s placebom, kar je pomanjkljivost in zbuja dvome v veljavnost rezultatov.
With respect to the formulation, there is some evidence that gastro-resistant tablets might provide some advantages in terms of safety as compared to immediate release formulation.
V zvezi s formulacijo obstajajo dokazi, da bi lahko gastrorezistentne tablete imele določene prednosti z vidika varnosti v primerjavi s formulacijami s takojšnjim sproščanjem.
As only very small amounts are found, however, these do not generally present any risk to the child and weaning is not usually necessary.
Ker pa v mleko prehajajo majhne količine, v splošnem ne predstavljajo tveganja za otroka in dojenja navadno ni treba prekiniti.
Among the mood stabilizers lithium has the longest track record and is therefore a reasonable first choice.
Med stabilizatorji razpoloženja ima litij najdlje dokazano učinkovitost in je zato smiselna prva izbira.
Valproate is a well-known anti-epileptic substance.
Valproat je dobro znan antiepileptik.
Children may be allowed to grow out of the dose per kg body weight instead of making age-related dose adjustments, whereby EEG findings should not deteriorate.
Otroci lahko prerastejo odmerek na kg telesne mase, namesto da se odmerek prilagaja glede na starost, pri čemer pa se rezultati EEG ne smejo poslabšati.
National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Pristojni nacionalni organi, ki jih medsebojno usklajuje referenčna država članica, bodo zagotovili, da bo imetnik dovoljenja za promet z zdravilom izpolnil naslednje pogoje:
The daily dose will be determined according to age and body weight.
Dnevni odmerek se določi glede na starost in telesno maso.
Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Zato je treba bolnike spremljati za znake samomorilnih misli in vedenja ter razmisliti o ustreznem zdravljenju.
The safety profile of valproate is well characterised from forty years of experience in the treatment of epilepsy.
Varnostni profil valproata je dobro znan po zaslugi štiridesetih let izkušenj z zdravljenjem epilepsije.
- acute mania and for the prevention of recurrence in patients with bipolar disorder - Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive.
- akutna manija in za preprečevanje ponovnega pojava pri bolnikih s polarno motnjo - manije, pri kateri ste lahko vzburjeni, vzneseni, nemirni, navdušeni ali hiperaktivni.
The major potentially serious safety concerns relate to liver dysfunction and pancreatitis.
Glavni morebitni resni zadržki glede varnosti so povezani z nepravilnim delovanjem jeter in pankreatitisom.
Chemical forms and formulations of valproate
Kemijske oblike in formulacije valproata
However, it has recently been estimated that up to 40% of the patients with bipolar disorder do not or insufficiently respond to an adequate lithium therapy.
Vendar pa nedavne ocene kažejo, da se do 40 % bolnikov z bipolarno motnjo ne odziva oziroma se nezadostno odziva na ustrezno zdravljenje z litijem.
In addition, valproate has been used as the reference comparator treatment in many Phase III studies of atypical antipsychotic drugs in the treatment and prevention of mania.
Poleg tega se valproat uporablja kot referenčno primerjalno zdravilo v mnogih študijah faze III atipičnih antipsihotikov pri zdravljenju in preprečevanju manije.
They should be swallowed whole or in halves, not chewed, and taken with plenty of fluid (e.g. a glass of water).
Pogoltniti je treba cele ali polovice z veliko tekočine (npr. kozarcem vode).
Dedicated studies have shown that valproate can be used safely in combination with antipsychotic drugs.
Posebne študije so pokazale, da je valproat mogoče varno uporabljati v kombinaciji z antipsihotičnimi zdravili.
The treatment of bipolar disorder includes management of the current mood episode and prevention of recurrence of next mood episodes.
Zdravljenje bipolarne motnje vključuje obvladovanje trenutne razpoloženjske epizode in preprečevanje ponovitev naslednjih razpoloženjskih epizod.
1.3 Chemical forms and formulations of valproate
1.3 Kemijske oblike in formulacije valproata
After 12 months of treatment following a manic index episode, 41% of patients treated with valproate were still in remission compared to 24% of patients in the lithium group and 13% of patients in the placebo group.
Po 12 mesecih zdravljenja po manični indeksni epizodi je bilo 41 % bolnikov, zdravljenih z valproatom, še vedno v remisiji v primerjavi s 24 % bolnikov v skupini z litijem in 13 % bolnikov v skupini s placebom.
As such, this represents one of the largest bodies of clinical trial data relating to the pharmacotherapy of bipolar disorder.
Tako to predstavlja enega največjih naborov podatkov s kliničnih preskušanj v zvezi z zdravljenjem bipolarne motnje z zdravili.
Concerning recurrence prevention of mood episodes, evidence of efficacy of valproate is mainly based on two double-blind studies with a maintenance period of 52 weeks and 20 months duration, respectively (Bowden et al., 2000 and Calabrese et al., 2005).
Z vidika preprečevanja ponovitev razpoloženjskih epizod temeljijo dokazi učinkovitosti valproata predvsem na dveh dvojno slepih študijah z obdobjem vzdrževanja 52 tednov oziroma trajanjem 20 mesecev (Bowden et al., 2000 in Calabrese et al., 2005).
After the Commission Decision the National Competent Authorities will update the product information as required.
Pristojni nacionalni organi bodo po odločbi Komisije posodobili informacije o zdravilu v skladu z zahtevami.
No unexpected signals have been identified from post-marketing surveillance.
Pri nadzoru zdravila v obdobju trženja ni bilo opaziti nepričakovanih znakov.
As conclusion the recurrence prevention of both mania and depression has not been demonstrated.
Iz navedenega sledi, da preprečevanje ponovitev manije in depresije ni bilo dokazano.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Bolnikom (in skrbnikom bolnikov) je treba svetovati, naj se posvetujejo z zdravnikom, če se pojavijo znaki samomorilnih misli ali vedenja.
In other words, the conducted studies demonstrate efficacy of valproate in the treatment of acute mania over 21 days, but evidence for the maintenance of the treatment effect up to 12 weeks of treatment is not considered complete.
Drugače povedano, izvedene študije dokazujejo učinkovitost valproata pri zdravljenju akutne manije nad 21 dni, vendar se dokazi o ohranitvi učinka zdravljenja do 12 tednov zdravljenja ne štejejo za popolne.
Bipolar disorder is a severe mental disorder characterized by recurrent episodes of mania and depression, which as a recurrent affective illness produces significant distress and dysfunction, ranking among the top 30 causes of worldwide disability.
Bipolarna motnja je huda duševna motnja, za katero so značilne ponavljajoče se epizode manije in depresije, ki kot ponavljajoča se afektivna bolezen povzroča hudo stisko in disfunkcijo, ki je med 30 najpogostejšimi vzroki nezmožnosti v svetovnem merilu.
Following the European Commission Decision the Risk Management Plan should be submitted with any new application for extending the indication regarding the treatment of mania in bipolar disorder.
V skladu z odločbo Evropske komisije je treba načrt za obvladovanje tveganja predložiti z vsako novo vlogo za razširitev indikacije v zvezi z zdravljenjem manije pri bipolarni motnji.
In most of the EU Member States valproate is also approved (as valproic acid, sodium valproate, valproate semisodium) for the treatment of patients with bipolar disorder (approved in 25 European countries, in 21 countries with a first-line indication).
V večini držav članic EU je valproat (kot valprojska kislina, natrijev valproat, seminatrijev valproat) odobren tudi za zdravljenje bolnikov z bipolarno motnjo (odobren v 25 evropskih državah, v 21 državah kot zdravilo prve izbire).
4.4 Special warnings and precautions for use
4.4 POSEBNA OPOZORILA IN PREVIDNOSTNI UKREPI
The safety and efficacy of {invented name} for the treatment of manic episodes in bipolar disorder have not been evaluated in patients aged less than 18 years.
Varnosti in učinkovitosti zdravila {lastniško ime} za zdravljenje maničnih epizod pri bipolarni motnji niso ocenili pri bolnikih, mlajših od 18 let.
There is also some evidence for maintenance of effect in treatment of acute mania episode (up to 12 weeks), although the 12 weeks studies lack a placebo arm, which is a deficiency.
Obstaja tudi nekaj dokazov ohranitve učinka pri zdravljenju epizod akutne manije (do 12 tednov), čeprav v 12-tedenski študiji ni bilo skupine s placebom, kar je pomanjkljivost.
The evidence of the efficacy of valproate in the treatment of bipolar disorder comes from sixteen randomised, comparative double-blind or open-label clinical trials.
Dokazi učinkovitosti valproata pri zdravljenju bipolarne motnje izhajajo iz šestnajstih randomiziranih, primerjalnih, dvojno slepih ali odprtih kliničnih preskušanj.
Ratiopharm Nederland B.V. Florapark 4
Nizozemska ratiopharm Nederland bv Florapark 4
Experience with long-term use of Valproinsäure-ratiopharm chrono is limited, particularly in children under 6 years of age.
Izkušnje z dolgotrajno uporabo zdravila [BLAGOVNA ZNAMKA] so omejene, predvsem pri otrocih, mlajših od šest let.
Mania occurs in an illness called “bipolar disorder”.
Manija se pojavi pri bolezni, imenovani »bipolarna motnja«.
Withdrawal must take the form of a gradual dose reduction over a period of one to two years.
Zdravljenje je treba prekiniti s postopnim zmanjševanjem odmerka v enem ali dveh letih.
Note: These amendments to the summary of product characteristics and package leaflet are valid at the time of the Commission Decision.
Opomba: Te spremembe povzetka glavnih značilnosti zdravila in navodila za uporabo so veljavne ob izdaji odločbe Komisije
{Invented name} can be used when lithium can not be used.
Zdravilo {lastniško ime} se lahko uporablja, kadar ni mogoče uporabiti litija.
The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect.
Odmerek je treba povečati čim hitreje, kot je mogoče, da se doseže najmanjši terapevtski odmerek, ki omogoča želeni klinični učinek.
This medicine should not be used during pregnancy and in women of child-bearing potential unless clearly necessary (i.e. in situations where other treatments are ineffective or not tolerated).
To zdravilo se ne sme uporabljati med nosečnostjo in pri ženskah v rodni dobi, razen če je to nujno potrebno (tj. kadar so druge oblike zdravljenja neučinkovite ali jih bolnica ne prenaša).
Therefore the CHMP recommended that valproate in the indication treatment of acute episodes is restricted to modified-release (solid oral) formulations.
Zato je CHMP priporočil, da se valproat pri indikaciji zdravljenja akutnih epizod uporablja le v obliki (trdnih peroralnih) formulacij s prirejenim sproščanjem.
Therefore, in women envisaging a pregnancy, valproate should not be used for the treatment of manic episodes, unless safer alternatives prove to be ineffective or are not tolerated.
Zato se pri ženskah, ki nameravajo zanositi, valproat ne sme uporabljati za zdravljenje maničnih epizod, razen če so varnejše alternative dokazano neučinkovite ali jih bolnica ne prenaša.
A teratogenic risk associated with the use of valproate in pregnant women, including the potential for delayed intellectual development has been identified following in utero exposure to valproate.
Tveganje za teratogenost, povezano z uporabo valproata pri nosečnicah, vključno z morebitnim zakasnjenim intelektualnim razvojem, je bilo opredeljeno glede na izpostavljenost valproatu v maternici (in utero).
The MAHs should look into their respective safety databases and add the appropriate frequency of occurrence to the above additional adverse events.
Imetniki dovoljenja za promet z zdravilom morajo preveriti svoje zbirke podatkov o varnosti in vanje dodati ustrezno pogostnost ponovitev zgoraj navedenih dodatnih neželenih učinkov.
Ask your doctor or pharmacist for advice before taking any medicine.
Dojenje Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.