natgillin/translations-raw huggingface dataset:
A medicinal product listed in Annex IB may be considered critical by the Member State(s) based on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective Member State(s) and, as appropriate, the nature of the disease to be treated.
Zdravilo, navedeno v Prilogi IB, se lahko šteje za zdravilo kritičnega pomena v eni ali več državah članicah na podlagi ocene morebitnih neizpolnjenih zdravstvenih potreb ter ob upoštevanju razpoložljivosti ustreznih alternativnih zdravil v eni ali več zadevnih državah članicah in, če je primerno, narave zdravljene bolezni.
The CHMP is of the opinion that these studies can not be used to establish bioequivalence with the EU reference medicinal product and therefore to support a generic marketing authorisation.
Meni tudi, da teh študij ni mogoče uporabiti za določitev biološke enakovrednosti z referenčnim zdravilom, odobrenim v EU, s katero bi podprli dovoljenje za promet z generičnim zdravilom.
Should during this period the Member State(s) consider a medicinal product not critical anymore, the suspension of the concerned marketing authorisation shall apply.
Če v tem obdobju ena ali več držav članic zdravila ne šteje več za zdravilo kritičnega pomena, je treba zahtevati začasen umik zadevnega dovoljenja za promet z zdravilom.
Hence, the CHMP cannot rule out beyond reasonable doubt that critical GCP violations at the site have affected the said studies.
Posledično odbor CHMP ne more nedvomno izključiti možnosti, da so na zadevne študije vplivale kritične kršitve dobre klinične prakse na lokaciji.
The category encompasses products for which MAHs have not provided any biowaiver request or bioequivalence study vis-à-vis the EU reference medicinal product generated elsewhere than at GVK Biosciences Pvt. Ltd. facility in Hyderabad, India, or where MAHs have not responded.
V tej kategoriji so zajeta zdravila, za katera imetniki dovoljenj za promet z zdravilom niso predložili zahtevka za izvzetje iz obveznosti izvedbe študije biološke enakovrednosti ali študije biološke enakovrednosti z referenčnim zdravilom, odobrenim v EU, opravljene drugje kot na lokaciji družbe GVK Biosciences Pvt. Ltd. v Hyderabadu oziroma se niso odzvali.
For products of Annex IA containing Levetiracetam, Levocetirizine and Metoclopramide, the CHMP considers that the biowaiver request is acceptable.
Odbor CHMP meni, da je za zdravila iz Priloge IA, ki vsebujejo levetiracetam, levocetirizin in metoklopramid, zahtevek za izvzetje iz obveznosti izvedbe študije biološke enakovrednosti sprejemljiv.
The CHMP therefore concluded that all bioequivalence studies with clinical activities carried out at GVK Bio site in Hyderabad, India, since GVK Bio started these activities in 2004 are considered unreliable to support the benefit risk balance of the medicinal products they relate to.
Tako je zaključil, da se vse študije biološke enakovrednosti, za katere so se klinične dejavnosti izvajale na lokaciji družbe GVK Bio v Hyderabadu štejejo za nezanesljive v smislu podpiranja razmerja med tveganji in koristmi zdravil, na katera se nanašajo, pri čemer to velja od leta 2004, ko je družba GVK Bio začela izvajati te dejavnosti.
Subsequently, for AU generic dossier submission, a bioequivalence study was performed using Alembic's Irbesartan Hydrochlorothiazide Film-coated Tablets 300mg/25 mg against the AU reference product AVAPRO HCT 300mg Film-coated Tablets sourced from Australian market.
Posledično je bila za avstralsko vlogo za generično zdravilo izvedena študija biološke enakovrednosti, v kateri so primerjali zdravilo Irbesartan Hydrochlorothiazide 300/25 mg filmsko obložene tablete družbe Alembic z referenčnim zdravilom, odobrenim v Avstraliji, AVAPRO HCT 300 mg filmsko obložene tablete z avstralskega trga.
The CHMP is of the view that this argument does not substitute the need to establish bioequivalence with an EU reference medicinal product in order to conclude on the positive benefitrisk balance of the concerned medicinal products.
Odbor CHMP meni, da ta utemeljitev ne zadošča, da ne bi bilo treba ugotoviti biološke enakovrednosti z referenčnim zdravilom, odobrenim v EU, s katero bi potrdili pozitivno razmerje med tveganji in koristmi za zadevna zdravila.
• Category 3: New bioequivalence vis-à-vis the EU reference medicinal product study submitted Discussions on the above took place during the December 2014 CHMP plenary meeting during which the CHMP endorsed the above mentioned classification.
Razprave o navedenem so potekale na plenarnem zasedanju odbora CHMP decembra 2014, na katerem je ta potrdil zgoraj navedeno razvrstitev.
The CHMP recommends therefore the suspension of the concerned marketing authorisations.
Odbor CHMP zato priporoča, da se zadevna dovoljenja za promet z zdravilom začasno umaknejo.
Therefore the CHMP is of the opinion that the studies cannot be relied upon to establish bioequivalence vis-àvis the EU reference medicinal product.
Zato meni, da se na študije v smislu ugotavljanja biološke enakovrednosti z referenčnim zdravilom, odobrenim v EU, ni mogoče zanesti.
• Category 2: New biowaiver request submitted
• Kategorija 2: predložen nov zahtevek za izvzetje iz obveznosti izvedbe študije biološke enakovrednosti.
Without prejudice to the above requirement, the CHMP reviewed the MAHs argumentation and considered from a scientific perspective that it is not established with the provided data that both
Brez poseganja v zgornjo zahtevo je odbor CHMP pregledal utemeljitev imetnikov dovoljenj za promet z zdravilom in menil, da z znanstvenega vidika iz predloženih podatkov ni mogoče ugotoviti, ali sta referenčni zdravili, odobreni v Avstraliji in v EU, enaki (npr. proizvodni obrati niso znani, količinska sestava ni znana).
For the remaining medicinal products in category 3 (products of Annex IB containing Clindamycin, Esomeprazole, Phenoxymethylpenicillin, Trimetazidine), the issues precluding the establishment of bioequivalence to an EU Reference Medicinal Product pertain to: The identity of test product in the study with the authorized (marketed) product is not clear.
Za preostala zdravila kategorije 3 (tj. zdravila v Prilogi IB, ki vsebujejo klindamicin, esomeprazol, fenoksimetilpenicilin in trimetazidin) se vprašanja, zaradi katerih ni mogoče ugotoviti biološke enakovrednosti z referenčnim zdravilom, odobrenim v EU, nanašajo na naslednje: identiteta testnega zdravila, ki se je v okviru študije primerjalo z odobrenim (trženim) zdravilom, ni jasna; ni bilo podano celotno poročilo o študiji biološke enakovrednosti, predložen je bil le povzetek študije; referenčno zdravilo ni odobreno za uporabo v EU; za zdravilo s prirejenim sproščanjem manjka študija v stanju dinamičnega ravnovesja; za zdravilo s prirejenim sproščanjem manjka študija z enim odmerkom; predložen je bil le povzetek pilotne študije; testnemu zdravilu je v času izvedbe študije potekel rok uporabe; manjka celotno bioanalitično poročilo; izvzetje iz obveznosti izvedbe študije biološke enakovrednosti za manjšo jakost ni sprejemljivo, saj niso bili predloženi primerjalni profili raztapljanja v skladu s smernicami o študijah biološke enakovrednosti.
The medicine was to be used as an addition to other treatment.
Zdravilo naj bi se uporabljalo kot dodatek k drugim zdravilom.
The application was mainly based on the results of one main study involving 1,161 patients with an episode of acute heart failure.
Vloga je temeljila predvsem na rezultatih ene glavne študije, v katero so vključili 1 161 bolnikov z epizodo akutnega srčnega popuščanja.
The main measure of effectiveness was the extent to which dyspnoea was relieved, measured short-term (after 6, 12 and 24 hours) and over 5 days.
Glavno merilo učinkovitosti je bilo, v kolikšni meri se je dispneja izboljšala v kratkem času (po 6, 12 in 24 urah) ter po petih dneh.
The effects of Reasanz were first tested in experimental models before being studied in humans.
Učinki zdravila Reasanz so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The company that applied for authorisation is Novartis Europharm Ltd.
Vlogo za pridobitev dovoljenja je predložila družba Novartis Europharm Ltd.
Refusal of the marketing authorisation for Reasanz (serelaxin) EMA/299385/2014
Zavrnitev vloge za dovoljenje za promet z zdravilom Reasanz (serelaksin) EMA/299385/2014
The results included assigned values for a number of patients who had died or had required additional treatment for worsening symptoms and whose actual data were not used.
V rezultate so bile vključene pripisane vrednosti za številne bolnike, ki so umrli ali so potrebovali dodatno zdravljenje zaradi poslabšanja simptomov in katerih dejanski podatki niso bili uporabljeni.
Furthermore, the Committee had concerns about the way the effectiveness of the medicine in the study had been analysed.
Poleg tega je imel pomisleke glede načina analize učinkovitosti zdravila v študiji.
On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Reasanz, intended for the treatment of acute heart failure.
Odbor za zdravila za uporabo v humani medicini (CHMP) je 23. januarja 2014 sprejel negativno mnenje, s katerim je priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Reasanz, namenjenim za zdravljenje akutnega srčnega popuščanja.
Refusal of the marketing authorisation for Reasanz (serelaxin)
Zavrnitev vloge za dovoljenje za promet z zdravilom Reasanz (serelaksin)
The active substance in Reasanz, serelaxin, is a recombinant form of relaxin-2, a hormone naturally found in the body.
Zdravilna učinkovina v zdravilu Reasanz, serelaksin, je rekombinantna oblika relaksina-2, ki je naravno prisoten hormon v telesu.
Reasanz is a medicine that contains the active substance serelaxin.
Reasanz je zdravilo, ki vsebuje zdravilno učinkovino serelaksin.
Recombinant means that it is produced by bacteria into which a gene (DNA) has been introduced that makes the bacteria able to produce the hormone.
Rekombinanten pomeni, da ga izdelajo bakterije, v katere so vstavili gen (DNK), s pomočjo katerega lahko tvorijo ta hormon.
At the time of the initial evaluation, the CHMP noted that the study results did not demonstrate a benefit for short-term relief of dyspnoea over up to 24 hours, and although some benefit was shown over 5 days it was not clear how this was of clinical relevance.
V času začetnega vrednotenja je odbor CHMP ugotovil, da rezultati študije niso potrdili koristi pri kratkoročni ublažitvi dispneje v največ 24 urah in da kljub temu, da se je po petih dneh pokazala določena korist, ni jasno, kakšen je njen klinični pomen.
Reasanz was expected to be used to treat the symptoms of acute heart failure (an episode of severe or worsening symptoms in patients in whom the heart cannot pump sufficient blood around the body).
Zdravilo Reasanz naj bi se uporabljalo za zdravljenje simptomov akutnega srčnega popuščanja (epizode hudih simptomov ali poslabšanja simptomov pri bolnikih, pri katerih srce ne more načrpati dovolj krvi za celotno telo).
When serelaxin attaches to receptors for relaxin in the blood vessels, it causes these vessels to relax and widen.
Ko se serelaksin veže na receptorje za relaksin v krvnih žilah, povzroči, da se žile sprostijo in razširijo.
In addition, the CHMP questioned whether the type of the background treatment given to patients in the two study groups might have influenced the results.
Odbor je izrazil tudi pomislek, da je morda vrsta osnovnega zdravljenja, ki so ga prejemali bolniki v obeh proučevanih skupinah, vplivala na rezultate.
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 May 2014.
Po preučitvi podlage za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in dne 22. maja 2014 potrdil zavrnitev vloge za dovoljenje za promet z zdravilom.
Therefore, although the safety of Reasanz seemed acceptable, the CHMP concluded that the benefits of Reasanz did not outweigh its risks and maintained its previous recommendation that the medicine be refused marketing authorisation.
Zato je kljub temu, da je varnost zdravila Reasanz ocenil za sprejemljivo, zaključil, da koristi zdravila Reasanz ne odtehtajo z njim povezanih tveganj, in potrdil svoje prejšnje priporočilo, da se dovoljenje za promet z njim zavrne.
These symptoms include high blood pressure in the vessels leaving the lungs, leading to congestion (fluid build-up) and dyspnoea (shortness of breath).
Simptomi vključujejo visok krvni tlak v žilah, ki izstopajo iz pljuč, kar povzroči zamašitev (nabiranje tekočin) in dispnejo (kratko sapo).
During the re-examination, the CHMP reviewed again the data from the only main study submitted and confirmed its opinion that the effectiveness of Reasanz had not been sufficiently demonstrated.
Med postopkom ponovnega pregleda je odbor CHMP še enkrat pregledal podatke iz edine predložene glavne študije in potrdil mnenje, da učinkovitost zdravila Reasanz ni bila zadostno dokazana.
What is Reasanz?
Kaj je zdravilo Reasanz?
pressure in the blood vessels and makes it easier for the heart to pump blood around the body, which helps to relieve the symptoms of acute heart failure.
S tem se zniža tlak v krvnih žilah, zaradi česar srce lažje črpa kri po telesu, to pa pomaga ublažiti simptome akutnega srčnega popuščanja.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Reasanz.
Družba je odbor CHMP obvestila, da zavrnitev nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Reasanz.
Since only one main study was included in the application, the CHMP concluded that further studies would be needed to confirm the effectiveness of Reasanz in the treatment of acute heart failure.
Glede na to, da je bila v okviru vloge predložena samo ena glavna študija, je odbor CHMP zaključil, da so za potrditev učinkovitosti zdravila Reasanz pri zdravljenju akutnega srčnega popuščanja potrebne dodatne študije.
How is Reasanz expected to work?
Kako naj bi zdravilo Reasanz delovalo?
What was Reasanz expected to be used for?
Za kaj naj bi se zdravilo Reasanz uporabljalo?
Reasanz infusion was compared with placebo (a dummy treatment) as an addition to their other treatment.
V njej so primerjali infuzijo zdravila Reasanz in placebo (zdravilo brez zdravilne učinkovine), ki so ju dodajali drugemu zdravilu.
It was to be available as a concentrate to be diluted and given by infusion (drip) into a vein.
Na voljo naj bi bilo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
Overall summary of the scientific evaluation of Tibolona Aristo and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Tibolona Aristo in povezanih imen (glejte Prilogo I)
• the CHMP considered that the available data confirms that the results of the bioequivalence study are reliable and demonstrate the bioequivalence of the proposed products and the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Tibolona Aristo and associated names (see Annex I).
je odbor CHMP priporočil odobritev dovoljenj za promet z zdravili, za katera povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostajajo enaki kot zadnje različice, pripravljene med postopkom usklajevalne skupine, kot je navedeno v Prilogi III za zdravilo Tibolona Aristo in povezana imena (glejte Prilogo I).
Infants and children
Dojenčki in otroci
• Section 3: How to use X
• Poglavje 3: Kako uporabljati zdravilo X
• third trimester of pregnancy
• tretje trimesečje nosečnosti
Your doctor will tell you how to take <invented name>.
Zdravnik vam bo povedal, kako jemati zdravilo <izmišljeno ime>.
Section 2: What you need to know before you use X This following wording should be reflected in this section.
Poglavje 2: Kaj morate vedeti, preden boste uporabili zdravilo X V tem poglavju mora biti izraženo naslednje besedilo.
Existing wording should be amended as necessary.
Obstoječe besedilo je treba ustrezno popraviti.
The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Obstoječe informacije o zdravilu je treba spremeniti (vstaviti, zamenjati ali izbrisati besedilo, kot je primerno), tako da bodo izražale odobreno besedilo, ki je navedeno spodaj.
• Section 4.3 Contraindications
• Poglavje 4.3 - Kontraindikacije
Text in strikethrough should be deleted from the summary of product characteristics, if present.
Prečrtano besedilo je treba izbrisati iz povzetka glavnih značilnosti zdravila, če je prisotno.
<Invented name> will be given to you as injection into your vein or into muscle.
Zdravilo <izmišljeno ime> boste prejeli v obliki injekcije v veno ali mišico.
575 mg capsules
575 mg kapsule
Especially the repeated use of metamizole during breastfeeding must therefore be avoided.
Zaradi tega se je zlasti ponavljajoči uporabi metamizola med dojenjem treba izogibati.
Adults and adolescents 15 years of age or older
Odrasli in mladostniki, stari 15 let ali več
This following wording should be reflected in this section.
V tem poglavju mora biti izraženo naslednje besedilo.
250 mg tablets
250 mg tablete
There is no experience available with long-term use.
Z dolgotrajno uporabo ni izkušenj.
In order to minimize the risk of a hypotensive reaction, the intravenous injection must be administered very slowly.
Da bi kar se da zmanjšali tveganje za hipotenzivno reakcijo, mora biti intravensko injiciranje zelo počasno.
3-11 months intramuscular only
11 mesecev samo intramuskularno
In animals metamizole induced reproductive toxicity but no teratogenicity (see Section 5.3).
Pri živalih je metamizol povzročil reproduktivno toksičnost, teratogenosti pa ne (glejte poglavje 5.3).
During the last three months of pregnancy you must not take <invented name> because of an increased risk of complications for the mother and child (haemorrhaging, premature closure of an important vessel, the so-called Ductus Botalli, of the unborn, which naturally closes only after birth).
V zadnjih treh mesecih nosečnosti zdravila <izmišljeno ime> ne smete jemati, zaradi povečanega tveganja za zaplete pri materi in otroku (krvavitev, prezgodnje zaprtje pomembne žile, t. i. Botallovega voda, pri nerojenem otroku, ki se praviloma zapre šele po rojstvu).
There are only limited data available on the use of metamizole in pregnant women.
Na voljo je le malo podatkov o uporabi metamizola pri nosečnicah.
To date, there has been insufficient experience with long-term use of metamizole in patients with severe hepatic and renal impairment.
Do zdaj še ni dovolj izkušenj z dolgotrajno uporabo metamizola pri bolnikih s hudo okvaro jeter ali ledvic.
A. Summary of Product Characteristics
Povzetek glavnih značilnosti zdravila
If the effect of a single dose is insufficient or later, when the analgesic effect subsides, your doctor may administer another dose up to a daily maximum dose as detailed below.
Če je učinek posameznega odmerka nezadosten, ali pozneje, ko analgetični učinek izzveni, vam lahko zdravnik da še en odmerek, do največjega dnevnega odmerka, kot je opisano v nadaljevanju.
Maximum daily dose
Največji dnevni odmerek
Based on published data from pregnant women exposed to metamizole during the first trimester (n=568) no evidence for teratogenic or embryotoxic effects was identified.
Na podlagi objavljenih podatkov o nosečnicah, ki so bile metamizolu izpostavljene v prvem trimesečju nosečnosti (n = 568), ni mogoče dokazati teratogenih ali embriotoksičnih učinkov.
Use during the third trimester is associated with fetotoxicity (renal impairment and ductus arteriosus constriction) and thus the use of metamizole is contraindicated during the third trimester of pregnancy (see section 4.3).
Uporaba v tretjem trimesečju je povezana s fetotoksičnostjo (okvara ledvic in konstrikcija arterioznega duktusa), zato je uporaba metamizola v tretjem trimesečju nosečnosti kontraindicirana (glejte poglavje 4.3).
The following dosage scheme for single doses intravenous (except infants below 1 year) or intramuscular should be used as a guide:
Naslednjo shemo odmerjanja posameznih intravenskih (razen pri dojenčkih, mlajših od 1 leta) ali intramuskularnih odmerkov uporabljajte kot vodilo:
Elderly and patients in poor general health/with renal impairment
Starejši in bolniki s šibkim splošnim zdravjem/okvaro ledvic
Metamizole crosses the placental barrier.
Metamizol prehaja skozi posteljico.
The following table shows recommended single doses and maximum daily doses depending on weight or age:
V naslednji preglednici so prikazani priporočeni posamezni odmerki in največji dnevni odmerki glede na telesno maso in starost:
For all formulations including fixed combination medicinal products:
Za vse farmacevtske oblike, vključno z zdravili s fiksno kombinacijo:
The breakdown products of metamizole pass into breast-milk in considerable amounts and a risk to the breastfed infant cannot be excluded.
Razgradni produkti metamizola prehajajo v materino mleko v pomembnih količinah, zato tveganja za dojenega dojenčka ni mogoče izključiti.
In selected cases single doses of metamizole during the first and second trimester might be acceptable when no other treatment options exist.
V določenih primerih so lahko posamezni odmerki metamizola v prvem in drugem trimesečju sprejemljivi, kadar ne obstaja nobena druga možnost zdravljenja.
Available data on the use of metamizole during the first three months of pregnancy is limited but do not indicate harmful effects to the embryo.
Na voljo so omejeni podatki o uporabi metamizola v prvem trimesečju nosečnosti, vendar ne nakazujejo škodljivih učinkov za zarodek.
All formulations including fixed combination medicinal products o Do not use X: - if you are in the last three months of pregnancy - if you are breast-feeding
Za vse farmacevtske oblike, vključno z zdravili s fiksno kombinacijo: o Zdravila X ne uporabljajte: - če ste v zadnjem trimesečju nosečnosti če dojite
Patients with impaired kidney or liver function
Bolniki z okvaro ledvic ali jeter
In case of inadvertent use of metamizole during the third trimester amniotic fluid and the ductus arteriosus should be controlled by ultrasound and echocardiographia.
V primeru nenamerne uporabe metamizola v tretjem trimesečju je treba z ultrazvokom in ehokardiografijo spremljati amnijsko tekočino in arteriozni duktus.
However, in general, the use of metamizole during the first and second trimester is not recommended.
Na splošno pa se uporaba metamizola v prvem in drugem trimesečju ne priporoča.
In case of a single administration of metamizole mothers are advised to collect and discard the breastmilk for 48 hours after the dose.
V primeru posameznega odmerka metamizola materam svetujemo, da 48 ur po odmerku mleko zbirajo in ga zavržejo.
In children under 1 year of age, metamizole should be injected by the intramuscular route only.
Pri otrocih, mlajših od 1 leta, se sme metamizol injicirati samo intramuskularno.
• Section 4.2 Posology and method of administration
• Poglavje 4.2 - Odmerjanje in način uporabe
500 mg/ml oral drops, solution (1 ml = 20 drops)
500 mg/ml peroralne kapljice, raztopina (1 ml = 20 kapljic)
Amendments to relevant sections of the Product Information
Spremembe zadevnih poglavij informacij o zdravilu
In children under 1 year of age, <invented name> should be injected by the intramuscular route only.
Pri otrocih, mlajših od 1 leta, se sme zdravilo <izmišljeno ime> injicirati samo intramuskularno.
Age (body weight)
Starost (telesna masa)
<Invented name> is not recommended for adolescents less than 15 years and children, as formulations containing less active substance are needed.
Zdravilo <izmišljeno ime> se ne priporoča pri mladostnikih, mlajših od 15 let, in pri otrocih, saj ti potrebujejo pripravke, ki vsebujejo manj učinkovine.