natgillin/translations-raw huggingface dataset:
The marketing authorisation should therefore be suspended in all member states until the companies provide new studies showing therapeutic equivalence and being GCP compliant.
Dovoljenje za promet z zdravilom je zato treba v vseh državah članicah začasno umakniti, dokler družbe ne predložijo novih študij, ki bodo dokazovale terapevtsko enakovrednost in skladnost z načeli dobre klinične prakse.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that these medicines have not be shown to be equivalent to the reference medicine (Zoladex) and therefore the marketing authorisation should be suspended until therapeutic equivalence has been demonstrated.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da ni bilo dokazano, da so ta zdravila enakovredna referenčnemu zdravilu (Zoladex), in da je zato treba dovoljenja za promet z zdravili začasno umakniti, dokler ne bo dokazana terapevtska enakovrednost.
Based on the evaluation of the studies that were submitted in support of the marketing authorisation application and the scientific discussion within the Committee, the CHMP concluded that therapeutic equivalence has not been demonstrated and as such the benefit risk balance for these hybrid products was considered negative.
Na podlagi ocene študij, ki so bile predložene v podporo vlogi za pridobitev dovoljenja za promet z zdravilom, in znanstvene razprave v Odboru, je CHMP zaključil, da terapevtska enakovrednost ni bila dokazana, zato velja, da je razmerje med tveganji in koristmi teh hibridnih zdravil negativno.
The German medicines regulatory agency considered that a suspension of the marketing authorisation of the already authorised medicines was necessary as therapeutic equivalence with the reference medicinal product could not be guaranteed.
Nemška regulativna agencija za zdravila je menila, da je potreben začasni umik dovoljenj za promet z zdravili, ki so že bila odobrena, saj ni mogoče zagotoviti terapevtske enakovrednosti z referenčnim zdravilom.
Goserelin is marketed as a hybrid of Zoladex under the names Novimp, Goserelin Cell Pharma, Novosis Goserelin and associated names.
Goserelin se trži kot hibrid zdravila Zoladex pod tržnimi imeni Novimp, Goserelin Cell Pharma, Novosis Goserelin in povezanimi imeni.
The European Medicines Agency has completed a review of the clinical studies that were submitted as part of the marketing authorisation application of the hybrid (a type of generic) medicinal products Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names (goserelin, 3.6 mg implant).
Evropska agencija za zdravila je zaključila pregled kliničnih študij, ki so bile predložene kot del vloge za pridobitev dovoljenja za promet s hibridnimi (vrsta generičnih) zdravili Novosis Goserelin, Goserelin Cell Pharm, Novimp in povezanih imen (goserelin, 3,6 mg implantat).
Following an inspection, the German medicines regulatory agency found that the clinical studies performed as part of the marketing authorisation applications for some goserelin containing medicines were not conducted in accordance with Good Clinical Practice (GCP) and questioned whether their results could be relied on.
Nemška regulativna agencija za zdravila je po pregledu ugotovila, da klinične študije, ki so bile izvedene kot del vloge za pridobitev dovoljenja za promet z nekaterimi zdravili, ki vsebujejo goserelin, niso bile izvedene v skladu z načeli dobre klinične prakse, in izrazila dvom o zanesljivosti rezultatov teh študij.
whether the marketing authorisations for Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names should be maintained, varied, suspended or withdrawn across the EU.
Nemška agencija je dne 16. marca 2011 zadevo napotila na CHMP, da bi Odbor lahko izdal mnenje o tem, ali je treba dovoljenja za promet z zdravili Novosis Goserelin, Goserelin Cell Pharm, Novimp in povezanimi imeni ohraniti, spremeniti, začasno umakniti ali ukiniti po vsej EU.
The physician information should contain the following key messages:
Informacije za zdravnika morajo vsebovati naslednja ključna sporočila:
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Država članica mora zagotoviti, da bo izpolnjevala vse pogoje ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki so opisani spodaj:
• The need to evaluate patients for both active and inactive tuberculosis prior to starting the treatment, including use of appropriate screening tests,
• Potreba po ovrednotenju bolnikov za tako aktivno kot neaktivno tuberkulozo pred začetkom zdravljenja, vključno z uporabo ustreznih presejalnih testiranj
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Cimzia are provided with a physician information pack containing the following:
Imetnik dovoljenja za promet mora pred lansiranjem zdravila zagotoviti, da vsi zdravniki, ki bodo verjetno predpisovali/uporabljali zdravilo Cimzia, prejmejo paket z informacijami za zdravnike, ki vsebuje:
• The role and use of patient alert card.
• Vloga in uporaba opozorilne kartice za bolnika
• The contraindication of Cimzia in patients with history of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure being worsened by Cimzia,
• Kontraindikacije zdravila Cimzia pri bolnikih z anamnezo zmerne do hude srčne odpovedi (NYAHA III/IV) in možno tveganje za poslabšanje kongestivne odpovedi srca zaradi zdravila Cimzia
• The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Cimzia,
• Tveganje za resne okužbe, vključno z oportunističnimi bakterijskimi, virusnimi in glivičnimi okužbami pri bolnikih, ki se zdravijo z zdravilom Cimzia
• The risk of acute injection-related reactions and delayed serious systemic hypersensitivity reactions, the need for instructing patients on techniques for administration, and guidance for Health Care Professionals on how to report administration errors,
• Tveganje za akutne reakcije, povezane z injiciranjem in zakasnjene resne sistemske preobčutljivostne reakcije, potreba po izobraževanju bolnikov o načinu uporabe in vodenje strokovnjakov z zdravstvenega področja pri poročanju napak pri uporabi
24 August 2011
24. avgust 2011
The mutual recognition procedure (UK/V/0373/001/MR) started on 29 July 2010.
Postopek medsebojnega priznavanja (UK/V/0373/001/MR) se je začel 29. julija 2010.
The final opinion was converted into a Decision by the European Commission on 24 August 2011.
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 24. avgusta 2011.
The referral procedure started on 9 February 2011.
Napotitveni postopek se je začel 9. februarja 2011.
On 28 January 2011, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by two of the Concerned Member States, the Netherlands and Sweden, that the safety and efficacy of the product had not been sufficiently demonstrated.
Dne 28. januarja 2011 je Združeno kraljestvo, kot referenčna država članica, zadevo napotilo na Evropsko agencijo za zdravila v skladu s členom 33(4) Direktive 2001/82/ES zaradi pomislekov o varnosti, ki sta jih izrazili dve zadevni državi članici, Nizozemska in Švedska, da varnost in učinkovitost zdravila nista bili ustrezno dokazani.
names is positive, and therefore adopted an opinion on 6 April 2011 recommending the granting of the marketing authorisation.
povezana imena pozitiven, zato je 6. aprila 2011 sprejel mnenje, v katerem priporoča odobritev dovoljenja za promet z zdravilom.
The Committee appointed Dr Karolina Törneke as rapporteur and Ms Helen Jukes as co-rapporteur.
Odbor je za poročevalko imenoval dr. Karolino Törneke in za so-poročevalko g. Heleno Jukes.
The marketing authorisation holder, Dechra Ltd, submitted an application for Clavudale 50 mg via a mutual recognition procedure in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovak Republic, Spain and Sweden on the basis of the marketing authorisation granted by the United Kingdom.
Imetnik dovoljenja za promet z zdravilom, Dechra Ltd, je predložil vlogo za zdravilo Clavudale 50 mg v okviru postopka medsebojnega priznavanja v Avstriji, Belgiji, na Češkem, Danskem, Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Islandiji, Irskem, v Luksemburgu, na Nizozemskem, Norveškem, Poljskem, Portugalskem, na Slovaškem, v Španiji in na Švedskem na podlagi dovoljenja za promet z zdravilom, odobrenega v Združenem kraljestvu.
International non-proprietary name (inn): amoxicillin, clavulanic acid
Mednarodno nelastniško ime (INN): amoksicilin, klavulanska kislina
There was disagreement between the Reference Member State and these Concerned Member States on the demonstration of bioequivalence in the cat target species.
Referenčna država članica in zadevni državi članici se niso strinjale z dokazovanjem biološke enakovrednosti pri ciljni vrsti živali, tj. mačke.
The list of product names concerned is given in Annex I. The scientific conclusions for the granting of the marketing authorisation are provided in Annex II.
Seznam zadevnih zdravil je naveden v Prilogi I. Priloga II vsebuje znanstvene zaključke za odobritev dovoljenja za promet z zdravilom.
Written explanations were provided by the marketing authorisation holder on 11 April 2011.
Imetnik dovoljenja za promet z zdravilom je 11. aprila 2011 podal pisne obrazložitve.
The summary of product characteristics, labelling and package leaflet are provided in Annex III.
Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Prilogi III.
The application was submitted as a generic of the reference product, Synulox Palatable Tablets 50 mg marketed by Pfizer Ltd.
Vloga je bila predložena za generik referenčnega zdravila, Synulox Palatable Tablets 50 mg, ki ga trži družba Pfizer Ltd.
Clavudale 50 mg tablet for cats and dogs and associated names (Clavudale 50 mg) contains amoxicillin and clavulanic acid.
Zdravilo Clavudale 50 mg tablete za mačke in pse in povezana imena (Clavudale 50 mg) vsebujejo amoksicilin in klavulansko kislino.
Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Clavudale 50 mg tablet for cats and dogs and associated
Na podlagi ovrednotenja poročevalčeve ocene podatkov, ki so trenutno na voljo, je CVMP menil, da je profil razmerja med koristmi in tveganji za zdravilo Clavudale 50 mg tablete za mačke in pse in stran 2/2
Clavudale 50 mg is intended for the treatment of pathogen-specific skin infections, infections of the oral cavity, urinary tract infections, respiratory disease and enteritis.
Zdravilo Clavudale 50 mg se uporablja za zdravljenje kožnih okužb, okužb ustne votline, okužb sečil, bolezni dihal in enteritis, ki jih povzročajo določeni povzročitelji bolezni.
Ref. EMEA/CHMP/384877/2008
: EMEA/CHMP/556329/2008
Risperdal and associated names is as an antipsychotic, indicated for the treatment of schizophrenia, manic episodes associated with bipolar disorders, persistent aggression in patients with moderate to severe Alzheimer's dementia and treatment of persistent aggression in conduct disorder in children.
Zdravilo Risperdal in z njim povezana imena je antipsihotično zdravilo, indicirano za zdravljenje shizofrenije, manične epizode, povezane z bipolarnimi motnjami, persistentne agresivnosti pri bolnikih z zmerno do hudo Alzheimerjevo demenco in zdravljenje persistentne agresivnosti pri otrocih z vedenjskimi motnjami.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Risperdal and associated names International Non-Proprietary Name (INN): risperidone
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA Risperdal in z njim povezana imena Mednarodno nelastniško ime (INN): risperidon
It is available as film coated tablets, oro-dispersible tablets (rapidly disintegrating) and oral solution.
Zdravilo je na voljo v obliki filmsko obloženih orodisperzibilnih (hitro razkrajajočih se) tablet in peroralne raztopine.
On 24 July 2007 the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Risperdal and associated names.
Evropska komisija je dne 24. julija 2007 agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi uskladila nacionalno odobrene povzetke glavnih značilnosti zdravila, označevanje in navodilo za uporabo zdravila Risperdal in z njim povezana imena.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Risperdal and associated names approved across EU Member States, with respect to the indications, the posology and method of administration, the contra-indications, the special warnings and precautions for use and the interaction with other medicinal products and other forms of interaction.
Osnova za napotitev so bile razlike med povzetki glavnih značilnosti zdravila Risperdal in z njim povezanih imen v državah članicah EU pri indikacijah, odmerjanju in načinu uporabe, kontraindikacijah, posebnih opozorilih in previdnostnih ukrepih ter medsebojnem delovanju z drugimi zdravili in drugih vrstah interakcij.
The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Risperdal and associated names.
V CHMP so podali pozitivno mnenje 24. julija 2008, s katerim so priporočili uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo za zdravilo Risperdal in z njim povezana imena.
● At the request of the European Medicines Agency
• na zahtevo Evropske agencije za zdravila;
Date of first authorization: 19 September 2005 Date of latest renewal: 2 July 2010
Datum prve odobritve: 19. september 2005 Datum zadnjega podaljšanja: 2. julij 2010
Caution should be exercised in such situations.
V takih primerih je potrebna previdnost.
Independent Review **
neodvisni pregled **
You should tell your doctor:
Obvestite zdravnika, če:
In some cases dose reduction may be necessary.
V nekaterih primerih bo morda potrebno zmanjšanje odmerka.
- corresponds to percentage below threshold.
- ustreza odstotku pod pragom
Demographic characteristics were well balanced between the two treatment groups.
Demografske značilnosti so bile med obema zdravljenima skupinama dobro uravnotežene.
Talk to your doctor, he will need to regularly monitor you with some blood tests.
Posvetujte se z zdravnikom, ki vas bo moral redno spremljati z nekaterimi krvnimi testi;
Second and Further Line Treatment
Druga in nadaljnje linije zdravljenja
Plasma protein binding is approximately 95%.
Vezava na plazemske proteine znaša približno 95 %.
This disease can also be linked to the natural progression of your medical condition and can have a fatal outcome in some cases.
Ta bolezen je lahko povezana tudi z naravnim poslabšanjem vašega zdravstvenega stanja in se lahko v nekaterih primerih konča s smrtnim izidom.
A study in normal healthy volunteers provided an estimate of the absolute bioavailability of 59%.
Študija pri zdravih prostovoljcih je pokazala oceno absolutne biološke uporabnosti 59 %.
See also section 4 “Possible side effects”.
Glejte tudi poglavje 4 “Možni neželeni učinki”.
Patients in this study were not selected based on EGFR mutation status.
Bolniki v tej študiji niso bili izbrani glede na status mutacij EGFR.
This protein is known to be involved in the growth and spread of cancer cells.
Za to beljakovino je znano, da sodeluje pri rasti in razširjanju rakavih celic.
Red blood cell parameters were decreased and white blood cells, primarily neutrophils, were increased.
Parametri rdečih krvnih celic so bili znižani, parametri belih krvnih celic, v glavnem nevtrofilcev, pa so bili zvišani.
Placebo (months)
Placebo (meseci)
The effect on overall survival was explored across different patient subsets.
Učinek na celokupno preživetje so preiskovali v različnih podskupinah bolnikov.
1 In clinical study PA.3.
1 V kliničnem preskušanju PA.3.
The efficacy results are summarized in Table 3.
Rezultati o učinkovitosti so povzeti v preglednici 3.
** Can lead to dehydration, hypokalemia and renal failure.
** Lahko vodi v dehidracijo, hipokaliemijo in ledvično odpoved.
There was no change to Tmax or half-life.
Spremembe tmax ali razpolovnega časa ni bilo.
Tell your doctor if you have severe pain in your abdomen.
Zdravniku povejte, če imate hude bolečine v trebuhu.
Also, tell your doctor if you had peptic ulcers or diverticular disease in the past, as this may increase this risk.
Prav tako mu povejte, če ste v preteklosti imeli peptično razjedo ali divertikularno bolezen, ker lahko to poveča tveganje.
It is not known whether Tarceva has a different effect if your liver or kidneys are not functioning normally.
Ni znano, ali ima zdravilo Tarceva drugačen učinek, če vaša jetra ali ledvice ne delujejo normalno.
Tarceva has not been studied in patients under the age of 18 years.
Zdravila Tarceva niso proučevali pri bolnikih, mlajših od 18 let.
Symptoms started from a few days to several months after initiating Tarceva therapy.
Simptomi so se pojavili od nekaj dni do več mesecev po začetku zdravljenja z zdravilom Tarceva.
Including fatalities.
6 Vključno s smrtnimi primeri.
The first 330 patients were centrally assessed (response rate 6.2%); 401 patients were investigatorassessed (response rate 11.2%).
Prvih 330 bolnikov so ocenili centralno (odziv na zdravljenje 6,2 %); 401 bolnika pa so ocenili raziskovalci (odziv na zdravljenje 11,2 %).
The median duration of response was 34.3 weeks, ranging from 9.7 to 57.6+ weeks.
Mediana trajanja odgovora je bila 34,3 tedna v razponu od 9,7 do 57,6+ tedna.
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The study did not meet its primary endpoint.
Primarni cilj študije ni bil dosežen.
• Inflammatory reactions around the fingernail
• vnetne reakcije okrog nohtov,
5 Including increased alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin.
Vključno z zvišano alanin-aminotransferazo [ALT], aspartat-aminotransferazo [AST] in bilirubinom.
Cigarette smoking has been shown to reduce erlotinib exposure by 50-60%.
Pokazalo se je, da kajenje zmanjša izpostavljenost erlotinibu za 50 do 60 %.
Infections and infestations Infection*
Infekcijske in parazitske bolezni okužba*
The clinical relevance of this increase has not been established.
Klinični pomen tega povečanja ni znan.
It is important to keep taking Tarceva every day, as long as your doctor prescribes it for you.
Pomembno je, da vzamete zdravilo Tarceva vsak dan, dokler vam ga je zdravnik predpisal.
Erlotinib and smokers
Erlotinib in kadilci
Including fatalities (see section 4.4).
Vključno s smrtnimi primeri (glejte poglavje 4.4).
The treatment with this medicine is not recommended for children and adolescents.
Zdravljenje otrok in mladostnikov s tem zdravilom ni priporočljivo.
Results are shown in the table below (results for the group of metastatic and locally advanced patients are derived from exploratory subgroup analysis).
Izsledki so prikazani v spodnji preglednici (izsledki za skupini bolnikov z metastatsko in lokalno napredovalo boleznijo so iz eksplorativne analize podskupin).
What Tarceva is and what it is used for
Kaj je zdravilo Tarceva in za kaj ga uporabljamo
If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
V primeru, da se postavi diagnoza keratitisa, je treba skrbno razmisliti o koristih in tveganjih nadaljnjega zdravljenja.
EGFR is expressed on the cell surface of normal cells and cancer cells.
EGFR se izraža na celični površini normalnih in rakavih celic.
When dose adjustment is necessary, the dose should be reduced in 50 mg steps (see section 4.4).
Kadar je potrebno odmerek prilagoditi, ga je treba zmanjševati v korakih po 50 mg (glejte poglavje 4.4).
The clinical relevance of these differences is unclear.
Klinični pomen teh razlik ni znan.
The inhibition of glucuronidation may cause interactions with medicinal products which are substrates of UGT1A1 and exclusively cleared by this pathway.
Inhibicija glukuronidacije lahko povzroči interakcije z zdravili, ki so substrati UGT1A1 in se izločajo samo po tej poti.
In clinical practice, there may be other co-factors leading to an increased exposure to carboplatin like renal impairment.
V klinični praksi lahko obstajajo drugi dejavniki, ki vodijo k večji izpostavljenosti karboplatinu, kot je npr. ledvična okvara.
* Severe infections, with or without neutropenia, have included pneumonia, sepsis, and cellulitis.
* Hude okužbe z nevtropenijo ali brez nje so vključevale pljučnico, sepso in celulitis.
Due to the blocking of downstream-signaling, the proliferation of cells is stopped, and cell death is induced through the intrinsic apoptotic pathway.
Zaradi blokade nadaljnjega signaliziranja (downstream-signaling) se proliferacija celic ustavi in preko intrinzične apoptotične poti se sproži celična smrt.
It can also be prescribed if previous chemotherapy has not helped to stop your disease.
Lahko vam ga predpiše tudi, če predhodna kemoterapija ni ustavila bolezni.
-Stevens-Johnson syndrome/Toxic epidermal necrolysis7
- StevensJohnsonov sindrom/ toksična epidermalna nekroliza
Based on population pharmacokinetic analysis, the presence of an opioid appeared to increase exposure by about 11%.
Populacijska farmakokinetična analiza je pokazala, da lahko prisotnost opioida poveča izpostavljenost za približno 11 %.
When prescribing Tarceva, factors associated with prolonged survival should be taken into account.
Pri predpisovanju zdravila Tarceva je treba upoštevati dejavnike, povezane s podaljšanim preživetjem.
PVC blister sealed with aluminium foil containing 30 tablets.
PVC pretisni omot, zavarjen z aluminijevo folijo, ki vsebuje 30 tablet.
The safety and efficacy of erlotinib in the approved indications has not been established in patients under the age of 18 years.
Varnost in učinkovitost erlotiniba za odobrene indikacije pri otrocih, mlajših od 18 let, še nista bili dokazani.
-Keratitis -Conjunctivitis1
- keratitis - konjunktivitis1
A higher incidence has been observed in patients in Japan (see section 4.4).
Pri bolnikih na Japonskem so opazili višjo incidenco (glejte poglavje 4.4).
Psychiatric disorders Depression very common
Psihiatrične motnje depresija zelo pogosti
The consequences of this interaction for e.g. CNS toxicity have not been established.
Posledice tega medsebojnega delovanja na npr. toksičnost za CŽS niso znane.
If necessary the dose of erlotinib should be reduced, particularly if toxicity is observed.
Če je treba, odmerek erlotiniba zmanjšamo, še posebno pri pojavu toksičnosti.
Elderly population There have been no specific studies in elderly patients.
Starejši bolniki Specifičnih študij pri starejših bolnikih niso izvedli.
These were very common in clinical study PA.3 and common in clinical study BR.21.
Zvišanja so bila zelo pogosta v kliničnem preskušanju PA.3 ter pogosta v kliničnem preskušanju BR.21.
Tarceva or placebo was taken orally once daily until disease progression or unacceptable toxicity.
Zdravilo Tarceva ali placebo so bolniki jemali peroralno enkrat na dan do napredovanja bolezni ali nesprejemljive toksičnosti.
Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the foetus.
Pri nosečnicah se lahko zdravljenje nadaljuje le, če korist za mater upravičuje tveganje za plod.
Hypromellose (E464)
makrogol hipromeloza (E464)