natgillin/translations-raw huggingface dataset:
This inspection found that corrective measures previously agreed had not been appropriately implemented.
Pri tem inšpekcijskem pregledu so ugotovili, da predhodno dogovorjeni popravni ukrepi niso bili ustrezno izvedeni.
The Committee noted that recommendations on prohibitions of supply have been issued by the national supervisory authority.
Odbor je poudaril, da je priporočila o prepovedi dobave izdal nacionalni nadzorni organ.
* This document was revised on 14 October 2016 in line with an updated CHMP opinion clarifying recommendations concerning prohibition of supply.
* Dokument je bil pregledan 14. oktobra 2016 v skladu s posodobljenim mnenjem odbora CHMP, v katerem je odbor pojasnil priporočila o prepovedi dobave.
The review of medicines manufactured by Pharmaceutics International Inc, US, was initiated on 23 June 2016 at the request of the European Commission under Article 31 of Directive 2001/83/EC.
Pregled zdravil, ki jih izdeluje družba Pharmaceutics International Inc iz ZDA, se je začel 23. junija 2016 na zahtevo Evropske komisije v skladu s členom 31 Direktive 2001/83/ES.
The CHMP's recommendation concerning these medicines were sent to the European Commission, which issued a legally binding decision valid throughout the EU.
Priporočilo odbora CHMP v zvezi s temi zdravili je bilo nato predloženo Evropski komisiji, ki je izdala pravno zavezujoči sklep, veljaven po vsej EU.
• If you have any questions about your treatment with Ammonaps, speak to your doctor or pharmacist.
• Če imate kakršna koli vprašanja o zdravljenju z zdravilom Ammonaps, se posvetujte z zdravnikom ali farmacevtom.
EMA/826770/2016 Corr.*
5. december 2016 EMA/826770/2016 Rev.*
More information on Ammonaps can be found here.
Več informacij o zdravilu Ammonaps je na voljo tukaj.
Ammonaps is a medicine authorised in the EU through the centralised procedure, whereas the other medicines have been authorised through national procedures.
Ammonaps je zdravilo, ki je dovoljenje za promet v EU pridobilo po centraliziranem postopku, druga zdravila pa z nacionalnimi postopki.
• There was no impact on the quality of the medicines produced at this site and corrective measures are currently being taken at the site to address these issues.
• Vpliva na kakovost zdravil, izdelanih v tem obratu, ni bilo, v obratu pa se trenutno izvajajo popravni ukrepi, s katerimi bodo odpravili te težave.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 29/11/2016 (Ammonaps) and 5/12/2016 (Dutasteride Actavis and associated names, Lutinus and associated names and SoliCol D3).
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je izdala končni pravno zavezujoči sklep, ki velja za vse države članice EU, in sicer 29. novembra 2016 (za zdravilo Ammonaps) in 5. decembra 2016 (za zdravilo Dutasteride Actavis in povezana imena, zdravilo Lutinus in povezana imena in zdravilo SoliCol D3).
These related to the risk of cross-contamination (the possible transfer of one medicine to another) and deficiencies in the systems for ensuring medicines' quality (quality assurance).
Te pomanjkljivosti so se nanašale na tveganje za navzkrižno kontaminacijo (možen prenos enega zdravila v drugega) in pomanjkljivosti sistemov, ki zagotavljajo kakovost zdravil (zagotavljanje kakovosti).
For Lutigest/Lutinus, some batches produced at the US site were still available on the EU market and were to be recalled.
Za zdravilo Lutigest/Lutinus so bile nekatere serije, proizvedene v obratu v ZDA, še vedno na voljo na evropskem trgu in jih je bilo treba odpoklicati.
There were also problems with the way data were generated and checked and deficiencies in the systems for ensuring medicines' quality (quality assurance).
Težave so bile tudi pri pridobivanju in preverjanju podatkov, sistemi, ki zagotavljajo kakovost zdravil (zagotavljanje kakovosti), pa so bili pomanjkljivi.
The medicine is only to be marketed once evidence is provided that its manufacturing is compliant with GMP standards.
Zdravilo se bo lahko tržilo šele, ko bodo predloženi dokazi, da je njegova proizvodnja skladna s standardi dobre proizvodne prakse;
The recommendation from EMA's Committee for Medicinal Products for Human Use (CHMP) has the following impact on availability of medicines from Pharmaceutics International Inc:
Priporočilo Odbora za zdravila v uporabo v humani medicini (CHMP) pri agenciji je imelo naslednji učinek na razpoložljivost zdravil iz družbe Pharmaceutics International Inc:
• Failings have been found at a manufacturing site in the United States that produces medicines marketed in the EU.
• V proizvodnem obratu v Združenih državah, v katerem se proizvajajo zdravila, ki se tržijo v EU, so bile najdene napake.
The medicines from these alternative sites therefore remain available in the EU.
Zdravila, proizvedena v drugih obratih, zato v EU ostajajo na voljo.
On 15 September the European Medicines Agency (EMA) recommended that medicines manufactured by Pharmaceutics International Inc, located in the United States, should no longer be available in the EU, except Ammonaps (sodium phenylbutyrate), which is considered critical for public health.
Evropska agencija za zdravila (EMA) je 15. septembra 2016 priporočila, da zdravila, ki jih proizvaja družba Pharmaceutics International Inc. s sedežem v Združenih državah, ne smejo biti več na voljo na trgu EU, z izjemo zdravila Ammonaps (natrijev fenilbutirat), ki je ključnega pomena za javno zdravje.
Although there was no evidence of harm or lack of effectiveness with any of the medicines, as a precaution, non-critical medicines from this site are no longer available in the EU.
Kljub odsotnosti dokazov o škodljivosti ali neučinkovitosti pri katerem koli od teh zdravil je bilo kot previdnostni ukrep sprejeto, da zdravila iz tega obrata, ki niso ključnega pomena, v EU ne bodo več na voljo.
• However, as a precautionary measure, medicines manufactured by Pharmaceutics International Inc that are not considered critical to public health are no longer to be used in the EU.
• Kot previdnostni ukrep pa se zdravila, ki jih izdeluje družba Pharmaceutics International Inc in ki niso ključna za javno zdravje, v EU ne smejo več uporabljati.
The medicines that are produced at the Pharmaceutics International Inc site in the United States are: Ammonaps (sodium phenylbutyrate), Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone) and SoliCol D3 (colecalciferol).
Zdravila, ki jih izdeluje družba Pharmaceutics International Inc v Združenih državah, so: Ammonaps (natrijev fenilbutirat), Dutasteride Actavis (dutasterid), Lutigest/Lutinus (progesteron) in SoliCol D3 (holekalciferol).
Although there was no evidence of a defect in any of the medicines produced at the site or of harm to patients, the site was required to implement corrective measures to ensure compliance with GMP standards.
Čeprav ni bilo dokazov o nobeni napaki pri zdravilih, proizvedenih v tem obratu, ali o škodljivosti za bolnike, so zahtevali, da se v obratu izvedejo popravni ukrepi za zagotavljanje skladnosti s standardi dobre proizvodne prakse.
• The manufacturing site Pharmaceutics International Inc in the United States which makes a number of medicines has been found to have several shortcomings in its good manufacturing practice.
• V proizvodnem obratu družbe Pharmaceutics International Inc v Združenih državah, v katerem proizvajajo več zdravil, je bilo najdenih več pomanjkljivosti pri dobri proizvodni praksi.
In countries where alternatives are available, your doctor will consider putting you on another treatment.
V državah, v katerih so na voljo druge možnosti zdravljenja, bo zdravnik razmislil o zamenjavi zdravila.
• In patients receiving Ammonaps orally (either as tablets or granules), other phenylbutyratecontaining medicines should be considered instead.
• Za bolnike, ki prejemajo zdravilo Ammonaps peroralno (v oblik tablet ali zrnc), je treba namesto njega razmisliti o drugih zdravilih, ki vsebujejo fenilbutirat.
Ammonaps should only be used in patients when no alternative treatment is available.
Zdravilo Ammonaps se sme uporabljati pri bolnikih le, kadar ni na voljo druge možnosti zdravljenja.
• SoliCol D3 (cholecalciferol), a medicine for vitamin D deficiency which is also exclusively produced at Pharmaceutics International Inc but has not yet been marketed in the EU, will not be made available in the EU.
• SoliCol D3 (holekalciferol), zdravilo za zdravljenje pomanjkanja vitamina D, ki ga prav tako proizvaja izključno družba Pharmaceutics International Inc, vendar v EU še ni na trgu, v EU ne bo na voljo.
Ammonaps granules should only be used in patients who have a feeding tube such as a nasogastric tube or gastrostomy and require the medicine.
Zdravilo Ammonaps v obliki zrnc se lahko uporablja samo pri bolnikih s hranilno sondo, kot sta nazogastrična sonda ali gastrostoma, ki to zdravilo potrebujejo.
In EU countries where treatment alternatives exist, Ammonaps will be recalled.
V državah EU, v katerih obstaja druga možnost zdravljenja, bo zdravilo Ammonaps odpoklicano;
• Other Pharmaceutics International Inc medicines have alternative manufacturing sites and therefore their availability is unaffected.
• Druga zdravila družbe Pharmaceutics International Inc se izdelujejo v drugih proizvodnih obratih, zato njihova razpoložljivost ostaja nespremenjena.
• The medicines Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone), and associated names, are registered to be produced at Pharmaceutics International Inc, but are now
• proizvodnja zdravil Dutasteride Actavis (dutasterid) in Lutigest/Lutinus (progesteron) in povezana imena je registrirana v družbi Pharmaceutics International Inc, vendar se zdaj izdelujeta v drugih
Ammonaps has been recalled in countries where alternatives are available.
Zdravilo Ammonaps so v državah, v katerih so na voljo druge možnosti zdravljenja, odpoklicali.
• One of the medicines manufactured at this site is Ammonaps (sodium phenylbutyrate), a medicine to treat urea cycle disorders.
• Eno od zdravil, ki se izdelujejo v tem obratu, je Ammonaps (natrijev fenilbutirat), zdravilo za zdravljenje motenj v ciklusu sečnine.
• One of the medicines affected, Ammonaps (sodium phenylbutyrate), used to treat inherited metabolic disorders, is considered a critical medicine and remains on the market where there are no alternatives.
• Eno od zadevnih zdravil, Ammonaps (natrijev fenilbutirat), ki se uporablja za zdravljenje dednih presnovnih motenj, je zdravilo ključnega pomena in ostaja na trgu tam, kjer ni drugih možnosti zdravljenja.
• Other medicines (Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone), and associated names) produced at the site have alternative manufacturing sites and the availability of these medicines is unaffected.
• Druga zdravila (Dutasteride Actavis (dutasterid), Lutigest/Lutinus (progesteron) in povezana imena), ki se izdelujejo v tem obratu, imajo druga proizvodna mesta, zato njihova razpoložljivost ostaja nespremenjena.
The review was started after a follow-up inspection of the site by the UK medicines regulatory agency (MHRA) and the US FDA.
Priporočilo je bilo rezultat pregleda dobre proizvodne prakse v družbi Pharmaceutics International Inc. Pregled se je začel po nadaljnjem inšpekcijskem pregledu v proizvodnem obratu, ki sta ga opravili regulativna agencija Združenega kraljestva (MHRA) in agencija ZDA za zdravila in prehrano (FDA).
The manufacturing site had insufficient measures in place to reduce the risk that traces of one medicine could be transferred to another (cross-contamination).
Ukrepi za zmanjševanje tveganja za prenos sledov enega zdravila v drugega (navzkrižne kontaminacije) v tem obratu niso bili zadostni.
• Ammonaps, a medicine for treating urea cycle disorders which is exclusively manufactured at Pharmaceutics International Inc, remains available where there are no treatment alternatives.
• Ammonaps, zdravilo za zdravljenje motenj v ciklusu sečnine, ki ga proizvaja izključno družba Pharmaceutics International Inc, ostaja na voljo, kadar ni drugih možnosti zdravljenja.
Ammonaps may still be supplied where no alternatives are available
Zdravilo Ammonaps se lahko še naprej dobavlja, kadar ni na voljo druge možnosti zdravljenja.
manufactured at alternative registered manufacturing sites.
proizvodnih obratih.
This conclusion was accepted.
Ta zaključek je bil sprejet.
In June 2006 a Mutual Recognition Procedure started with The Netherlands as Reference Member State and six Concerned Member States.
Junija 2006 se je pričel postopek medsebojnega priznavanja z Nizozemsko kot referenčno državo članico ter šestimi zadevnimi državami članicami.
The CVMP Opinion was adopted on 18 April 2007 and the subsequent Commission Decision on 10 July 2007.
Mnenje CVMP je bilo sprejeto 18. aprila 2007, s tem povezana odločba Komisije pa 10. julija 2007.
London, June 2008 EMEA/532222/2007 - Rev.1
London, junij 2008 EMEA/532222/2007 - Rev.1
The CVMP during its meeting of December 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended for Enurace 50.
CVMP je med svojim zasedanjem decembra 2006 pričel napotitveni postopkom v skladu s členom 33(4) Direktive 2001/82/ES, kakor je bila spremenjena, za zdravilo Enurace 50.
France and Italy could not agree to the granting of a marketing authorisation as they considered there were potentially serious risks for animal health.
Francija in Italija se nista strinjali z odobritvijo dovoljenja za promet, saj sta menili, da obstajajo možna resna tveganja za zdravje živali.
The CVMP, therefore, concluded that the benefit/risk for this product was favourable.
CVMP je zato zaključil, da je razmerje med koristmi in tveganji za to zdravilo ugodno.
EMEA/532222/2007 - Rev.1
EMEA/532222/2007 - Rev.1-SL
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR ENURACE 50
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33(4) ZA ZDRAVILO ENURACE 50
The Marketing Authorisation Holder was requested to provide all supporting data to justify a positive benefit/risk ratio for the treated animal.
Od imetnika dovoljenja za promet z zdravilom je bilo zahtevano, da predloži vse podporne podatke, da bi upravičil pozitivno razmerje med koristmi in tveganji za zdravljeno žival.
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the Committee for Medicinal Products for Veterinary Use.
Zadeva je bila napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirane postopke za zdravila za uporabo v veterinarski medicini (CMD(v)) in nato na Odbor za zdravila za uporabo v veterinarski medicini.
These results were convincing when compared to the 20 % placebo treated animals that became continent in study ACE129801.
Ti rezultati so bili prepričljivi pri primerjavi z 20 % živali iz študije ACE129801, ki so bile zdravljene s placebom in postale kontinentne.
In response to the questions related to toxicity, the applicant argued that due to the pharmacologic effect of ephedrine and the individual variation in receptor density no safety margin could be determined and increasing doses will be associated to increased intensity and frequency of well known adverse effects.
V odgovoru na vprašanja, povezana s toksičnostjo, je predlagatelj navedel, da zaradi farmakološkega učinka efedrina in individualne variacije gostote receptorjev ni bilo mogoče določiti meje varnosti, višanje odmerka pa bo povezano z intenzivnostjo in pogostostjo dobro poznanih neželenih učinkov.
However, the study where Enurace 50 is compared to Propaline (ACE129802) is convincing although a non-inferiority analysis has not been performed.
Kljub vsemu je študija, v kateri so zdravilo Enurace 50 primerjali z zdravilom Propaline (ACE129802), prepričljiva, čeprav analiza enakovrednosti zdravil ni bila izvedena.
At the recommended dose level, which according to the suggested SPC should be individually adjusted, safety is ensured to a reasonable level.
Pri priporočenem odmerku, ki ga je treba v skladu s predlaganim povzetkom glavnih značilnosti zdravila individualno prilagoditi, je raven varnosti primerna.
Enurace 50 is a tablet formulation containing ephedrine as active ingredient and is indicated for treatment of urinary incontinence caused by urethral sphincter mechanism incompetence in ovariohysterectomised dogs.
Zdravilo Enurace 50 je pripravek v obliki tablet, ki vsebuje zdravilno učinkovino efedrin in je indicirano za zdravljenje urinarne inkontinence, ki je posledica nepravilnega delovanja sfinkterskega mehanizma uretre pri psicah po ovariohisterektomiji.
Efficacy data are connected to several shortcomings and the amount of data available is sparse.
Podatki o učinkovitosti imajo več pomanjkljivosti, poleg tega jih je malo.
Although toxicity data for the target animal may be scarce, the adverse effects connected to ephedrine treatment are well known from human use, and the applicant had provided some post-marketing information regarding the use in dogs.
Čeprav utegnejo biti podatki o toksičnosti za ciljno žival skromni, so neželeni učinki, povezani z zdravljenjem z efedrinom, dobro znani iz uporabe pri ljudeh, predlagatelj pa je predložil nekaj informacij v zvezi z uporabo pri psih po izdaji dovoljenja za promet.
The raw outcome shows good effect in both test and control groups, an effect that might be somewhat higher in treatment naïve animals.
Neobdelani rezultati izkazujejo dober učinek v testni in kontrolni skupini, ta učinek pa utegne biti pri zdravljenju predhodno nezdravljenih živali še nekoliko boljši.
France considered the benefit/risk analysis unfavourable for the animal when the adverse effects were weighed against the potential benefits of effective treatment of incontinence.
Francija je menila, da je analiza koristi in tveganj, če neželene učinke primerjamo z možnimi koristmi učinkovitega zdravljenja inkontinence, za žival neugodna.
With regard to the related to cardiovascular diseases, the SPC is to be modified under section 4.5 to include the sentence “the dog's cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment”.
Glede srčno-žilnih bolezni je treba poglavje 4.5 povzetka glavnih značilnosti zdravila dopolniti s stavkom „Pred začetkom zdravljenja z zdravilom Enurace 60 je treba natančno ugotoviti deloavnje srca in ožilja ter to med zdravljenjem redno spremljati“.
Italy could have accepted the application but with revised wording in the SPC.
Italija bi vlogo sprejela, vendar s popravljenim besedilom povzetka glavnih značilnosti zdravila.
Date of latest renewal: 19 November 2014
Datum prve odobritve: 15. marec 2010 Datum zadnjega podaljšanja: 19. november 2014
Do not stop the treatment unless your doctor tells you so.
Ne prekinite zdravljenja, razen če vam tega ne odredi zdravnik.
Some other medicines may influence the use of DuoPlavin or vice versa.
Nekatera druga zdravila lahko vplivajo na uporabo zdravila DuoPlavin in obratno.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
The safety and efficacy of DuoPlavin in children and adolescents under 18 years old have not been established.
Varnost in učinkovitost zdravila DuoPlavin pri otrocih in mladostnikih mlajših od 18 let nista ugotovljeni.
Refer to local requirements for disposal.
Upoštevajte lokalne zahteve za odlaganje.
Side effects with frequency not known (frequency cannot be estimated from the available data):
Možni neželeni učinki, katerih pogostnost ni znana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
Following toxic doses (10 20 g), the plasma half-life may be increased to over 20 hours.
Po toksičnih odmerkih (10 20 g) se lahko razpolovni čas v plazmi podaljša na več kot 20 ur.
• You should tell your doctor - if a surgery (including dental) is planned.
• morate povedati zdravniku: - če imate predvideno kakšno operacijo (vključno z zobozdravstvenim posegom).
DuoPlavin is not intended for use in children or adolescents less than 18 years of age.
Zdravilo DuoPlavin ni namenjeno uporabi pri otrocih in mladostnikih, mlajših od 18 let.
At low concentrations (<100 micrograms/ml), approximately 90% of salicylic acid is bound to albumin.
Pri nizkih koncentracijah (< 100 g/ml) je približno 90 % salicilne kisline vezane na albumin.
Depending on your condition, your doctor will determine the length of time for which you need to take DuoPlavin.
Zdravnik bo glede na vaše stanje določil, koliko časa morate jemati zdravilo DuoPlavin.
DuoPlavin is not recommended in this population.
Uporaba zdravila DuoPlavin se v tej populaciji ne priporoča.
Interactions with the following medicinal products have been reported with ASA:
Opisane so interakcije med ASA in naslednjimi zdravili:
** Information related to clopidogrel with frequency “not known”.
** Informacije v povezavi s klopidogrelom s pogostnostjo “ni znana”.
The European Medicines Agency has waived the obligation to submit the results of studies with DuoPlavin in all subsets of the paediatric population in the treatment of coronary atherosclerosis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveznosti po predložitvi rezultatov študij zdravila DuoPlavin pri vseh podskupinah pediatrične populacije za zdravljenje koronarne ateroskleroze (glejte poglavje 4.2 za informacije o pediatrični uporabi).
DuoPlavin should not be used during the first two trimesters of pregnancy unless the clinical condition of the woman requires treatment with clopidogrel/ASA.
Zdravilo DuoPlavin se ne sme uporabljati v prvih dveh trimesečjih nosečnosti, razen če klinično stanje nosečnice ne zahteva terapije s klopidogrelom / ASA.
In patients with ST segment elevation acute myocardial infarction: Therapy should be started as early as possible after symptoms start and continued for at least four weeks.
Pri bolnikih z akutnim miokardnim infarktom z elevacijo ST spojnice: zdravljenje je potrebno začeti čim prej po nastopu simptomov in z njim nadaljevati vsaj štiri tedne.
Patients should inform physicians and dentists that they are taking DuoPlavin before any surgery is scheduled and before any new medicinal product is taken.
Bolniki morajo obvestiti zdravnika in zobozdravnika, da jemljejo klopidogrel, pred vsakim načrtovanjem kirurškega posega in preden vzamejo katerokoli novo zdravilo.
Due to the presence of both components of the medicinal product, DuoPlavin is contraindicated in case of:
Zaradi vsebnosti obeh učinkovin v zdravilu, je zdravilo DuoPlavin kontraindicirano v primeru:
If patients must temporarily stop antiplatelet therapy, DuoPlavin should be discontinued 7 days prior to surgery.
Če mora bolnik začasno prekiniti antiagregacijsko terapijo morate zdravilo DuoPlavin ukiniti 7 dni pred kirurškim posegom.
If acetylsalicylic acid is used by a woman attempting to conceive, or until the 24th amenorrhea week (5th month of pregnancy), the dose should be kept as low and duration of treatment as short as possible.
Če acetilsalicilno kislino uporablja ženska, ki poskuša zanositi, ali do 24. tedna amenoreje (5. meseca nosečnosti), mora biti odmerek čim manjši, zdravljenje pa čim kratkotrajnejše.
What DuoPlavin is and what it is used for
Kaj je zdravilo DuoPlavin in za kaj ga uporabljamo
If the use of DuoPlavin is discontinued, patients may benefit with continuation of one antiplatelet medicinal product.
V primeru prenehanja uporabe zdravila DuoPlavin lahko bolniku koristi nadaljevanje uporabe enega antiagregacijskega zdravila.
If you experience prolonged bleeding when taking DuoPlavin If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Če doživite podaljšanje krvavitve v času jemanja zdravila DuoPlavin Če se urežete ali poškodujete, lahko traja dlje kot običajno, da se vam krvavitev ustavi.
A pharmacodynamic interaction between DuoPlavin and heparin is possible, leading to increased risk of bleeding.
Farmakodinamična interakcija med zdravilom DuoPlavin in heparinom je možna in vodi do povečanega tveganja za krvavitev.