natgillin/translations-raw huggingface dataset:
Adverse reactions related to renal function can occur after initiating Zurampic (see section 4.8).
Po uvedbi zdravila Zurampic se lahko pojavijo neželeni učinki na delovanje ledvic (glejte poglavje 4.8).
In both studies, significantly more patients treated with Zurampic 200 mg in combination with allopurinol achieved the target serum uric acid level of less than 6 mg/dL by Month 6 and by Month 12 compared with patients receiving placebo in combination with allopurinol (see Table 2).
V obeh študijah je ciljno koncentracijo sečne kisline manj kot 6 mg/dl do 6. in do 12. meseca doseglo značilno več bolnikov, ki so prejemali kombinacijo 200 mg zdravila Zurampic in alopurinola kot bolnikov, ki so prejemali kombinacijo placeba in alopurinola (glejte preglednico 2).
In the pivotal clinical trials, a greater proportion of patients using lipid lowering or antihypertensive medicines that were CYP3A substrates required concomitant medicinal product change when treated with Zurampic 200 mg in combination with a xanthine oxidase inhibitor, compared with patients treated with placebo in combination with a xanthine oxidase inhibitor (35% versus 28%, respectively).
Zamenjavo sočasnih zdravil je potreboval večji delež bolnikov, ki so obenem jemali kombinacijo 200 mg zdravila Zurampic in zaviralca ksantin-oksidaze, kot tistih, ki so jemali kombinacijo placeba in zaviralca ksantin-oksidaze (35 % prvih in 28 % drugih).
EU/1/15/1080/005 100x1 film-coated tablets (unit dose)
EU/1/15/1080/005 100x1 filmsko obložena tableta (enoodmerni pretisni omot)
EU/1/15/1080/004 98 film-coated tablets
EU/1/15/1080/004 98 filmsko obloženih tablet
Pharmacotherapeutic group: Antigout preparations, preparations increasing uric acid excretion ATC code: M04AB05
Oznaka ATC: M04AB05
Taking this medicine - take in the morning with food and water - takeZurampic at the same time as yourmorning dose of‘xanthine oxidase inhibitor' medicine allopurinol or febuxostat.
- Zdravilo Zurampic vzemite ob istem času kot jutranji odmerek zdravila, ki zavira ksantin oksidazo - alopurinola ali febuksostata.
Zurampic must be taken together with allopurinol or febuxostat, which are medicines called ‘xanthine oxidase inhibitors' and are also used to treat gout by lowering the amount of uric acid in your blood.
To sta zdravili, ki zavirata encim ksantin-oksidazo in se prav tako uporabljata za zdravljenje protina, ker zmanjšata količino sečne kisline v krvi.
However, the in vivo activity of OATP1B1, OAT1, OAT3 and OCT1 was not affected by lesinurad.
Toda in vivo lesinurad ni vplival na aktivnost OATP1B1, OAT1, OAT3 in OCT1.
Gout flares may occur after initiation of therapy with Zurampic.
Po uvedbi zdravila Zurampic se lahko pojavijo napadi protina.
EU/1/15/1080/003 30 film-coated tablets
EU/1/15/1080/003 30 filmsko obloženih tablet
A higher incidence of serum creatinine elevations and renal-related adverse reactions including serious adverse reactions was observed with Zurampic 400 mg when given alone or in combination with a xanthine oxidase inhibitor, with the highest incidence when Zurampic was given as monotherapy.
Med uporabo zdravila Zurampic 400 mg samega ali v kombinaciji z zaviralcem ksantin-oksidaze so opažali večjo incidenco porasta kreatinina v serumu in neželenih učinkov na ledvicah (vključno z resnimi neželenimi učinki); incidenca je bila največja, če je bilo zdravilo Zurampic uporabljeno samostojno (v monoterapiji).
EU/1/15/1080/002 28 film-coated tablets
EU/1/15/1080/002 28 filmsko obloženih tablet
Zurampic should be interrupted if serum creatinine is elevated to greater than 2 times the pre-treatment value or in case of an absolute serum creatinine value greater than 4.0 mg/dL.
Uporabo zdravila Zurampic je treba prekiniti, če se kreatinin v serumu zviša na več kot 2-krat tolikšno vrednost, kot je bila pred zdravljenjem, prav tako tudi v primeru absolutne vrednosti kreatinina v serumu nad 4,0 mg/dl. Zdravljenje je treba prekiniti pri bolnikih s simptomi, ki lahko kažejo na akutno urično nefropatijo: npr. z bolečinami v ledvenem predelu, navzeo ali bruhanjem; v tem primeru takoj izmerite kreatinin v serumu.
- each Zurampic 200mg film-coated tablet (tablet) contains 200mg of lesinurad.
Ena filmsko obložena tableta (tableta) zdravila Zurampic 200 mg vsebuje 200 mg lesinurada.
EU/1/15/1080/001 10 film-coated tablets
EU/1/15/1080/001 10 filmsko obloženih tablet
Timepoint
Izhodišče
Zurampic does not need to be discontinued because of a gout flare.
Zaradi napada protina zdravila Zurampic ni treba prenehati uporabljati.
Cmax and AUC exposures of lesinurad increased proportionally with single doses of lesinurad from 5 to 1,200 mg.
Cmax in AUC lesinurada sta se povečevali sorazmerno enkratnemu odmerku lesinurada v razponu od 5 do 1200 mg. Na poln želodec je bila geometrična sredina Cmax lesinurada po enkratnem odmerku 200 mg lesinurada 6 µg/ml in geometrična sredina njegove AUC 29 µg/h/ml.
Consistent serum uric acid lowering was observed in patients who were receiving low dose acetylsalicylic acid in the placebo-controlled clinical studies in combination with allopurinol or febuxostat.
V kliničnih študijah kombinacije z alopurinolom ali febuksostatom, kontroliranih s placebom, so opažali dosledno znižanje sečne kisline pri bolnikih, ki so jemali nizke odmerke acetilsalicilne kisline.
Zurampic 200 mg vs. placebo
200 mg zdravila Zurampic v primerjavi s placebom
A.
Sob.
Lesinurad undergoes oxidative metabolism mainly via cytochrome P450 (CYP) 2C9 to intermediate metabolite M3c (not detected in vivo) and is subsequently metabolised by mEH to metabolite M4; there is minimal contribution from CYP1A1, CYP2C19, and CYP3A to the metabolism of lesinurad.
Lesinurad se presnovi z oksidativno presnovo, predvsem s citokromom P450 (CYP) 2C9, v vmesni presnovek M3c (in vivo ga niso odkrili).
D.
Ned.
Dehydration
Odmerjanje
C.
Čet.
Tell your doctor before taking Zurampic if you have or have had heart failure or other heart problems.
Če imate ali ste kdaj imeli srčno popuščanje ali druge težave s srcem, morate to povedati zdravniku, preden začnete jemati zdravilo Zurampic.
Monitor for decreased efficacy when Zurampic is co-administered with a CYP2C9 inducer.
Če je zdravilo Zurampic uporabljeno sočasno s kakšnim induktorjem CYP2C9, bolnika kontrolirajte glede zmanjšane učinkovitosti.
100 x 1 film-coated tablets
10 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 98 filmsko obloženih tablet 100 x 1 filmsko obložena tableta
Zurampic contains lactose.
- če imate presajeno ledvico.
If you take Zurampic on its own you may be more likely to get kidney problems - drink plenty of water during the day.
Jemanje zdravila Zurampic samega lahko poveča verjetnost za težave z ledvicami.
In three 12-month placebo-controlled trials of Zurampic in combination with a xanthine oxidase inhibitor versus a xanthine oxidase inhibitor alone (placebo), serum creatinine elevations between 1.5fold and 2-fold over baseline occurred in 3.9% of patients on Zurampic 200 mg, 10.0% of patients on Zurampic 400 mg and 2.3% on placebo; serum creatinine elevations 2-fold or greater over baseline occurred in 1.8% of patients on Zurampic 200 mg, 6.7% of patients on Zurampic 400 mg and 0% on placebo.
V teh preskušanjih se je zvišanje kreatinina v serumu, ki je bilo od 1,5- do 2-kratnik izhodiščnega, pojavilo pri 3,9 % bolnikov, ki so prejemali 200 mg zdravila Zurampic, 10,0 % bolnikov, ki so prejemali 400 mg zdravila Zurampic in pri 2,3 % bolnikov, ki so prejemali placebo.
• adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
• odraslih in otrocih, starejših od treh let, z malignim gliomom, kakršna sta multiformni glioblastom ali anaplastični astrocitom, če se je tumor po standardnem zdravljenju ponovil ali poslabšal.
The full EPAR for Temozolomide Hexal 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 Temozolomide Hexal je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Hexal on 15 March 2010.
Evropska komisija je dovoljenje za promet z zdravilom Temozolomide Hexal, veljavno po vsej Evropski uniji, izdala 15. marca 2010.
This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Hexal.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Temozolomide Hexal.
This means that Temozolomide Hexal is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Temodal.
For more information about treatment with Temozolomide Hexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Temozolomide Hexal preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Temozolomide Hexal is used first with radiotherapy and then on its own;
Zdravilo Temozolomide Hexal se najprej uporabi skupaj z radioterapijo, nato pa samostojno;
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 Temozolomide Hexal.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Temozolomide Hexal should be taken without food.
Zdravilo Temozolomide Hexal je treba jemati brez hrane.
Because Temozolomide Hexal 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 Temozolomide Hexal generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
Treatment with Temozolomide Hexal should be prescribed by a doctor with experience in the treatment of brain tumours.
Zdravljenje z zdravilom Temozolomide Hexal mora predpisati zdravnik, ki ima izkušnje z zdravljenjem možganskih tumorjev.
The CHMP concluded that, in accordance with EU requirements, Temozolomide Hexal has been shown to have comparable quality and to be bioequivalent to Temodal.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Temozolomide Hexal primerljivo raven kakovosti kot zdravilo Temodal ter da mu je biološko enakovredno.
What are the benefit and risk of Temozolomide Hexal?
Kakšne so koristi in tveganja, povezani z zdravilom Temozolomide Hexal?
The Committee recommended that Temozolomide Hexal be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Temozolomide Hexal izda dovoljenje za promet.
Temozolomide Hexal is a ‘generic medicine'.
Temozolomide Hexal je „generično zdravilo“.
Because Temozolomide Hexal is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Ker je zdravilo Temozolomide Hexal generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Temodal.
Other information about Temozolomide Hexal
Druge informacije o zdravilu Temozolomide Hexal
The active substance in Temozolomide Hexal, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Zdravilna učinkovina zdravila Temozolomide Hexal, temozolomid, spada v skupino zdravil proti raku, imenovanih alkilirajoči citostatiki.
The dose of Temozolomide Hexal depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Odmerek zdravila Temozolomide Hexal je odvisen od telesne površine (izračunane glede na telesno višino in maso bolnika) in znaša od 75 do 200 mg na kvadratni meter, enkrat na dan. Odmerek in število odmerkov sta odvisna od vrste zdravljenega tumorja ter od tega, ali je bil bolnik že zdravljen, ali se zdravilo Temozolomide Hexal uporablja samostojno ali skupaj z drugimi zdravljenji in kako se bolnik odziva na zdravljenje.
Temozolomide Hexal is an anticancer medicine.
Temozolomide Hexal je zdravilo proti raku.
Why has Temozolomide Hexal been approved?
Zakaj je bilo zdravilo Temozolomide Hexal odobreno?
Temozolomide Hexal is a medicine that contains the active substance temozolomide.
Temozolomide Hexal je zdravilo, ki vsebuje zdravilno učinkovino temozolomid.
Temozolomide Hexal is used on its own in these patients.
Pri teh bolnikih se zdravilo Temozolomide Hexal uporablja samostojno.
Patients may also need to take medicines to prevent vomiting before taking Temozolomide Hexal.
Preden bolnik vzame zdravilo Temozolomide Hexal, bo morda moral vzeti tudi zdravilo za preprečevanje bruhanja.
How has Temozolomide Hexal been studied?
Kako je bilo zdravilo Temozolomide Hexal raziskano?
What is Temozolomide Hexal?
Kaj je zdravilo Temozolomide Hexal?
How does Temozolomide Hexal work?
Kako zdravilo Temozolomide Hexal deluje?
What is Temozolomide Hexal used for?
Za kaj se zdravilo Temozolomide Hexal uporablja?
How is Temozolomide Hexal used?
Kako se zdravilo Temozolomide Hexal uporablja?
1 spray container
1 pršilnik
(meat and milk)
(meso in mleko)
Meat: 7 days Milk: 60 hours
Meso: 7 dni Mleko: 60 ur
The CVMP considered that:
CVMP je upošteval naslednje:
Combisyn was authorised in the United Kingdom on 30 January 2003 under Article 13(1) of Directive 2001/82/EC.
Zdravilo Combisyn je bilo odobreno v Združenem kraljestvu dne 30. januarja 2003 v skladu s členom 13(1) Direktive 2001/82/ES.
The CVMP was unable to conclude positively on this approach.
CVMP ni mogel sprejeti pozitivnega sklepa glede tega pristopa.
Consequently the matter was referred to the CVMP.
Zato je bila zadeva napotena na CVMP.
The application was submitted to the Concerned Member States under the mutual recognition procedure.
Vloga je bila predložena zadevnim državam članicam po postopku z medsebojnim priznavanjem.
The conditions for lifting the suspension are outlined in Annex III.
Pogoji za preklic začasnega umika so navedeni v Dodatku III.
A user risk assessment and a Phase I environmental risk assessment were also provided.
Predloženi sta bili tudi ocena tveganja za uporabnika in ocena tveganja za okolje faze I.
• the efficacy of Combisyn was not confirmed;
• Učinkovitost zdravila Combisyn ni bila potrjena.
Recommended dose, frequency and route of administration
Priporočeni odmerek, pogostnost in pot uporabe zdravila
For applications made under Article 13(1) of Directive 2001/82/EC the applicant is not required to submit results of pharmacological, toxicological and clinical trials.
Za vloge, ki so bile predložene v skladu s členom 13(1) Direktive 2001/82/ES, predlagatelju ni treba predložiti rezultatov farmakoloških, toksikoloških in kliničnih preskušanj.
The Concerned Member States considered that the authorisation of Combisyn may present a potential serious risk to human and animal health since the safety and efficacy of the product had not been sufficiently demonstrated.
Zadevne države članice so menile, da bi odobritev zdravila Combisyn lahko predstavljala možno resno tveganje za zdravje ljudi in živali, saj varnost in učinkovitost zdravila nista bili ustrezno dokazani.
Prior to the lifting of the suspension of the marketing authorisation, the national competent authority of the Reference Member State shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Pred preklicem začasnega umika dovoljenja za promet z zdravilom mora pristojni nacionalni organ v referenčni državi članici zagotoviti, da imetnik dovoljenja za promet z zdravilom izpolnjuje naslednje pogoje:
No conclusions could be reached for clavulanic acid since levels were mostly below the limit of quantification.
Za klavulansko kislino ni bilo mogoče sprejeti nobenih zaključkov, saj so bile ravni večinoma pod mejo kvantifikacije.
List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, withdrawal periods, applicant, marketing authorisation holder in the member states
Seznam imen, farmacevtskih oblik, jakosti veterinarskega zdravila, živalskih vrst, poti uporabe, karenc, predlagateljev, imetnikov dovoljenja za promet z zdravilom v državah članicah
Therefore the CVMP concluded that the particulars submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC and recommended the refusal of granting the Marketing Authorisation in the Concerned Member States and the suspension of the existing Marketing Authorisation in the Reference Member State.
CVMP je zato sklenil, da predloženi podatki v podporo vlogi niso v skladu s členom 13 Direktive 2001/82/ES, ter priporočil zavrnitev odobritve dovoljenja za promet z zdravilom v zadevnih državah članicah in začasni umik obstoječega dovoljenja za promet z zdravilom v referenčni državi članici.
Furthermore, the applicant contended that milk was not excluded from the CVMP guideline for the conduct of bioequivalence studies (reference in section 5.1 to “other biological fluid”).
Predlagatelj je tudi trdil, da mleko ni bilo izključeno iz smernice CVMP za izvajanje študij biološke enakovrednosti (sklicevanje na „druge biološke tekočine“ v poglavju 5.1).
A residue depletion study in milk should be performed in accordance with the ‘Note for guidance for the determination of withdrawal periods for milk' (EMEA/CVMP/473/98-FINAL)
Izvesti se mora študija izločanja ostankov pri mleku v skladu z „Obvestilom o navodilu za določanje karence za mleko“ (EMEA/CVMP/473/98-FINAL).
The applicant presented comparative viscosity data between the ‘old' and ‘new' formulations of Combisyn.
Predlagatelj je predstavil primerjalne podatke o viskoznosti med „staro“ in „novo“ formulacijo zdravila Combisyn.
At the time of initial authorisation, the difficulties of attempting to demonstrate bioequivalence of intramammary preparations were less well known and the general principles applied by the applicant in conducting their package of pharmacokinetic studies were accepted.
V času prvotne odobritve so bile težave v zvezi z dokazovanjem biološke enakovrednosti intramamarnih pripravkov manj znane in sprejeta so bila splošna načela, ki jih je uporabil predlagatelj pri izvajanju farmakokinetičnih študij.
A design of non-inferiority to the reference product should be considered, with particular attention to assay sensitivity (e.g. a three-arm study with placebo).
Preučiti je treba zasnovo enakovrednosti z referenčnim zdravilom, s posebnim poudarkom na občutljivosti metode (na primer študija s tremi skupinami, s placebom).
During the procedure, there was disagreement between the Reference Member State and Concerned Member States on the applicability of demonstrating systemic bioequivalence for a locally-applied, locally-acting product, as well as an additional concern on the adequacy of the proposed withdrawal period.
Med postopkom je prišlo do nesoglasja med referenčno državo članico in zadevnimi državami članicami glede uporabnosti dokazovanja sistemske biološke enakovrednosti za lokalno uporabljeno in lokalno delujoče zdravilo, pojavili pa so se tudi dodatni zadržki glede ustreznosti predlagane karence.
The CVMP was asked to give its opinion on the concerns raised by the Concerned Member States and to conclude on the benefit/risk balance for Combisyn.
CVMP je bil naprošen, da poda mnenje v zvezi z zadržki, ki so jih izrazile zadevne države članice, in sprejme sklep glede razmerja med tveganji in koristmi za zdravilo Combisyn.
Overall summary of the scientific evaluation of Combisyn Lactating Cow Intramammary Suspension
Splošni povzetek znanstvenega vrednotenja zdravila Combisyn Lactating Cow Intramammary Suspension
This study also served to provide data on the residues of this active substance.
S to študijo so dobili tudi podatke o ostankih te zdravilne učinkovine.
The plasma data showed that, overall, the confidence intervals were within the acceptance limits for amoxicillin and prednisolone.
Podatki o plazmi so pokazali, da so bili na splošno intervali zaupanja v mejah sprejemljivosti za amoksicilin in prednizolon.
• it is not possible, on the basis of the data submitted in support of this application, to establish a positive benefit-risk balance for this product.
• Na podlagi predloženih podatkov v podporo vlogi ni mogoče določiti pozitivnega razmerja med tveganji in koristmi za to zdravilo.
Thus the current bioequivalence guidelines were not intended to apply to intramammary products as it is unclear to what extent a certain kinetic profile in milk correlates to behaviour at the site of action.
Veljavne smernice za biološko enakovrednost tako niso bile namenjene uporabi v zvezi z intramamarnimi zdravili, saj ni jasno, v kolikšni meri je določen kinetični profil v mleku soodvisen od odziva na mestu delovanja.
Appropriate clinical data should be provided to confirm the efficacy of Combisyn Lactating Cow Intramammary Suspension.
Predložiti je treba ustrezne klinične podatke za potrditev učinkovitosti zdravila Combisyn Lactating Cow Intramammary Suspension.
• the data submitted in support of this application failed to show that bioequivalence had been demonstrated by appropriate bioavailability studies between the test and reference products;
• Podatki, predloženi v podporo tej vlogi, niso pokazali, da je bila z ustreznimi študijami biološke razpoložljivosti dokazana biološka enakovrednost med preskušanim in referenčnim zdravilom.
It was concluded that the data set and statistical analyses used to extrapolate the proposed withdrawal period to 120 hours were flawed and did not provide an adequate basis upon which to derive a withdrawal period.
Ugotovljeno je bilo, da so bili podatki in statistične analize, ki so jih uporabili za ekstrapolacijo predlagane karence na 120 ur, pomanjkljivi in niso zagotovili ustrezne podlage za določitev karence.
An additional issue reviewed by the CVMP was a change in the formulation of Combisyn during development to increase the stability of the product, which was identified as potentially affecting the release of the active substances from the product into the tissue.
Dodatno vprašanje, ki ga je CVMP preučil, je bila sprememba formulacije zdravila Combisyn med razvojem, s čimer so želeli povečati stabilnost zdravila in za kar je bilo ugotovljeno, da bi lahko vplivalo na sproščanje zdravilne učinkovine iz zdravila v tkivo.
It was concluded that, although Combisyn was shown to be similar to the reference product with respect to formulation, particle size and viscosity, this could only be seen as supportive in this case and could not substitute clinical studies to demonstrate efficacy.
Sklenjeno je bilo, da je bilo sicer dokazano, da je zdravilo Combisyn podobno referenčnemu zdravilu glede formulacije, velikosti delcev in viskoznosti, vendar pa so v tem primeru to lahko le podporni podatki in ne morejo nadomestiti kliničnih študij za dokazovanje učinkovitosti.
The main principle behind bioequivalence is to compare the rate and extent of exposure so sampling cannot be made from the same compartment as administration and excretion.
Glavno načelo biološke enakovrednosti je primerjava stopnje in obsega izpostavljenosti, tako da se vzorčenje ne more izvajati na istem mestu, kot se zdravilo daje in izloča.
Scientific conclusions and grounds for refusal of the granting of the marketing authorisation(s)
Znanstveni zaključki in podlaga za zavrnitev odobritve dovoljenj(a) za promet z zdravilom