natgillin/translations-raw huggingface dataset:
The main measure of effectiveness was the time until the fracture was seen to have healed using an X-ray (time to radiographic fracture healing).
Glavno merilo učinkovitosti je bil čas, v katerem se je zlom zacelil, kar so ocenjevali z uporabo rentgena (čas do radiografsko potrjene zacelitve kosti).
TruScient must not be used in dogs that are hypersensitive (allergic) to dibotermin alfa or any of the other ingredients.
Zdravilo TruScient se ne sme uporabljati pri psih, ki so preobčutljivi za (alergični na) dibotermin alfa ali katero koli drugo sestavino zdravila.
TruScient is a medicine that contains the active substance dibotermin alfa.
TruScient je zdravilo, ki vsebuje zdravilno učinkovino dibotermin alfa.
The kit allows the user to make a solution containing the active substance (0.2 mg/ml) to be applied onto collagen sponges which are implanted during surgery.
Komplet uporabniku omogoča pripravo raztopine, ki vsebuje zdravilno učinkovino (0,2 mg/ml) za nanos na kolagensko gobico, ki se vstavi med operacijo.
The newly formed bone grows into the collagen sponge, which then dissolves away.
Novo nastala kost se zraste s kolagensko gobico, ki se nato razgradi.
Only the amount of prepared sponge needed to cover the affected area of the bone should be used.
Uporabite samo količino pripravljene gobice, ki bo prekrila prizadeti del kosti.
Time to radiographic fracture healing was less when the dogs were treated with TruScient together with standard surgical care.
Čas do radiografsko potrjene zacelitve kosti je bil krajši pri psih, zdravljenih z zdravilom TruScient skupaj s standardno kirurško oskrbo.
The prepared collagen sponges are implanted during surgery by placing them directly onto the bone fracture and leaving them in place when the surgical wound is stitched up.
Pripravljeni kolagenski gobici se vstavita med kirurškim posegom, tako da se namestita neposredno na zlom kosti in se tam pustita tudi po šivanju kirurške rane.
TruScient is used in combination with standard surgical care to treat diaphyseal bone fractures (affecting the diaphysis, the main section of long bone) in dogs.
Zdravilo TruScient se uporablja v kombinaciji s standardno kirurško oskrbo za zdravljenje diafiznih zlomov kosti (prizadenejo diafizo, glavni del dolge kosti) pri psih.
The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Za oceno razmerja med tveganji in koristmi glejte znanstveno razpravo tega evropskega javnega poročila o oceni zdravila (EPAR).
When the collagen sponge is implanted into the bone fracture, dibotermin alfa stimulates the bone tissue around the sponge to make new bone.
Po namestitvi kolagenskih gobic na zlom kosti dibotermin alfa spodbuja kostno tkivo okoli gobice, da tvori novo kost.
The study assessed TruScient used together with standard surgical care, compared with standard surgical care alone.
V študiji so ocenjevali uporabo zdravila TruScient skupaj s standardno kirurško oskrbo v primerjavi s samostojno kirurško oskrbo.
For a full list of all side effects reported with TruScient, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila TruScient, glejte navodilo za uporabo.
What is TruScient used for?
Za kaj se zdravilo TruScient uporablja?
The active substance in TruScient, dibotermin alfa, acts on the bone structure.
Zdravilna učinkovina v zdravilu TruScient, dibotermin alfa, deluje na strukturo kosti.
How has TruScient been studied?
Kako je bilo zdravilo TruScient raziskano?
If TruScient is accidentally spilled onto the skin or eyes, it should be rinsed off immediately.
V primeru nenamernega razlitja zdravila TruScient na kožo ali v oči jih nemudoma sperite.
What is TruScient?
Kaj je zdravilo TruScient?
How does TruScient work?
Kako zdravilo TruScient deluje?
The Reference Member State was Finland and the Concerned Member States were Austria, Denmark, Germany and Sweden.
Referenčna država članica je bila Finska, zadevne države članice pa so bile Avstrija, Danska, Nemčija, in Švedska.
International Non-Proprietary Name (INN): Lansoprazole
Mednarodno nelastniško ime (INN): Lansoprazol
The final opinion was converted into a Decision by the European Commission on 15 September 2005.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 15. septembra 2005.
The Rapporteur and Co-Rapporteur appointed were Sif Ormarsdottir/Tomas Salmonson, Gottfried Kreutz/Julia Dunne respectively.
Za poročevalca in soporočevalca so bili imenovani Sif Ormarsdottir/Tomas Salmonson, Gottfried Kreutz/Julia Dunne.
The arbitration procedure started on 20 January 2005.
Arbitražni postopek se je začel 20. januarja 2005.
The Concerned Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the
Zadevne države članice niso mogle doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je podelila referenčna država članica.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III.
A Mutual Recognition Procedure was started on 16 September 2004.
Postopek za medsebojno priznavanje se je začel 16. septembra 2004.
The Marketing Authorisation Holder provided written explanations on 13 April 2005.
Imetnik dovoljenja za promet z zdravilom je podal pisna pojasnila 13. aprila 2005.
Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Nemčija je 15. decembra 2004 Evropski agenciji za zdravila podala razloge za nesoglasje.
During its June 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for
Na sestanku v juniju 2005, je CHMP glede na vse predložene podatke ter znanstveno razpravo znotraj Odbora menil, da je razmerje med koristmi in tveganji za zdravilo Lansoprazol Hexal ugodno.
Lansoprazol HEXAL (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastro-oesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Lansoprazol Hexal (lansoprazol) je zaviralec protonske črpalke, ki zavira izločanje želodčne kisline in se uporablja za zdravljenje razjed dvanajstnika in želodca, refluksnega vnetja požiralnika, gastroezofagealne refluksne bolezni, zdravljenje in preprečevanje razjed želodca in dvanajstnika, povezanih z jemanjem nesteroidnih protivnetnih zdravil (NSAID), zdravljenje Zollinger-Ellisonovega sindroma in v kombinaciji z ustreznim protibakterijskim zdravljenjem za eradikacijo Helicobacter pylori ter preprečevanje ponovitve peptične razjede pri bolnikih z razjedami, povezanimi s H. pylori.
Significant differences in comparison to the reference product have been identified with regard to the indications' section of the SPCs.
V primerjavi z referenčnim zdravilom so bile ugotovljene znatne razlike v zvezi z razdelkom o indikacijah v Povzetku glavnih značilnosti zdravila.
A Marketing Authorisation for Lansoprazol HEXAL (15 mg and 30 mg) was previously granted to
Lansoprazol Hexal 15 mg in 30 mg
The SPC of the reference product in Germany does not contain the indications related to the concomitant use of NSAIDs and the treatment and prevention of gastric and duodenal ulceration caused by these compounds.
Povzetek glavnih značilnosti zdravila za referenčno zdravilo v Nemčiji ne vsebuje indikacij, povezanih s sočasno uporabo nesteroidnih protivnetnih zdravil (NSAID) ter zdravljenjem in preprečevanjem razjed dvanajstnika in želodca, ki jih povzročajo te snovi.
The indications related to the concomitant use of NSAIDs and the treatment and prevention of gastric and duodenal ulceration caused by these compounds were supported.
Podprl je indikacije, povezane s sočasno uporabo nesteroidnih protivnetnih zdravil (NSAID) in zdravljenjem ter preprečevanjem razjed želodca in dvanajstnika, ki jih povzročajo te snovi.
15 September 2005 EMEA/CHMP/230471/2005
EMEA/CHMP/230471/2005 ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(2)1 ZA
Hexal AG in Finland on 7 November 2003.
Dovoljenje za promet z zdravilom Lansoprazol Hexal (15 mg in 30 mg) je bilo prvotno dodeljeno družbi Hexal AG iz Finske 7. novembra 2003.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
PRILOGA I SEZNAM IMEN, FARMACEVTSKE OBLIKE, JAKOSTI ZDRAVILA, NAČINA UPORABE, PREDLAGATELJA, IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Content (concentration)
Način uporabe Vsebina (koncentracija)
The corresponding decision from the commission was issued on 12 May 2011.
Ustrezna odločba Komisije je bila izdana 12. maja 2011.
Overall, the following should be taken into account:
Ob upoštevanju naslednjega,
The Singaporean manufacturing plant was only used once and no longer considered as an alternative.
Proizvodni obrat v Singapurju je bil uporabljen samo enkrat in se ne šteje več kot nadomestna možnost.
The conditions affecting the marketing authorisations are set out in Annex IV of the opinion.
Pogoji, ki vplivajo na dovoljenja za promet z zdravili, so navedeni v Prilogi IV mnenja.
- The current minimum standards for critical process parameters and limits e.g. for terminal sterilisation should be reviewed and improved, in compliance with process capabilities and best practice.
- Trenutni minimalni standardi za kritične parametre in omejitve postopka, na primer za končno sterilizacijo, morajo biti pregledani in izboljšani v skladu z zmogljivostmi postopka in najboljšo prakso.
Consequently bioburden specifications of the filled containers should also be harmonised.
Posledično je treba uskladiti tudi specifikacije mikrobne obremenitve v napolnjenih vsebnikih.
The CHMP reviewed all the data available for each of the sites concerned.
CHMP je pregledal vse razpoložljive podatke za vsak zadevni proizvodni obrat.
The necessary data packages to support the inclusion of one more additional manufacturing site located in Europe (Poland) which is expected to become fully operational soon, was also expedited.
Potrebni podatkovni paketi v podporo vključitvi enega dodatnega proizvodnega obrata, ki se nahaja v Evropi (Poljska), ki naj bi kmalu postal popolnoma operativno sposoben, so bili prav tako pospešeni.
The sterilisation process should be re-validated using biological indicators as per Ph. Eur..
Postopek sterilizacije se mora ponovno validirati z uporabo bioloških indikatorjev, kot je navedeno v Evropski farmakopeji.
The coordinated review of the conditions by the CHMP will enable the appropriate harmonious adjustments with minimum impact on supply of PD solutions to the EU market.
Usklajen pregled pogojev CHMP bo omogočil ustrezne usklajene prilagoditve s kar najmanjšim vplivom na oskrbo tržišča EU z raztopinami za PD.
The present opinion is the second of a series of entwined opinions, which may result subsequently in additional measures being requested for the site subject of the current opinion.
Trenutno mnenje je drugo v vrsti prepletajočih se mnenj, zaradi katerih bodo posledično morda potrebni dodatni ukrepi, ki jih bodo morali izvesti v obratu, za katerega je izdano to mnenje.
Additional measures may be requested subsequently for these sites, but pending conclusion of the ongoing article 31 these cannot be identified.
Naknadno se lahko za te proizvodne obrate zahtevajo tudi dodatni ukrepi, vendar le teh ni mogoče določiti pred zaključkom postopka v skladu s členom 31.
The available data to support inclusion of sites from which products are currently being imported (Canada, Turkey and USA) into the existing PD solutions marketing authorisations were submitted.
Predloženi so bili razpoložljivi podatki v podporo vključitvi obratov, v katerih se proizvajajo zdravila, ki se trenutno uvažajo (Kanada, Turčija in ZDA), v obstoječa dovoljenja za promet z raztopinami za PD.
The CHMP considers of extreme importance to retain coordination of the review of the conditions presently identified for the site in the USA.
CHMP meni, da je vzdrževanje koordinacije pregleda stanja, trenutno ugotovljenega na proizvodnem obratu v ZDA, zelo pomembno.
The introduction of a more sensitive kinetic turbidimetric limulus amebocyte lysate (LAL) method for endotoxin testing and the re-submission of the full description of the manufacturing processes for all sites together with its critical review should thus be undertaken.
Zato je treba vključiti bolj občutljive kinetične turbidimetrične metode LAL (testi na osnovi lizata, pridobljenega iz krvi podkvastih rakov) za preverjanje endotoksinov in ponovno predložiti celoten opis proizvodnega procesa za vse proizvodne obrate, skupaj s kritičnim pregledom.
Considering the likelihood of prolonged use of large quantities of unlicensed (imported) PD solutions on the EU market, and in order to ensure continued supply of licensed medicinal products to the EU, the necessary data packages to support the inclusion of additional manufacturing sites were expedited within the ongoing article 31 referral procedure.
Ob upoštevanju verjetnosti podaljšane uporabe večjih količin raztopin za PD brez licence (uvoženih) na trgu EU in za zagotovitev nemotene dobave zdravil z licenco v EU so bili v podporo vključitvi dodatnega proizvodnega obrata pospešeno vključeni potrebni podatkovni paketi v potekajoči napotitveni postopek v skladu s členom 31.
- All drug substances should be supported by active substance master files or appropriate data and comply with Ph Eur requirements.
- Vse zdravilne učinkovine morajo biti ustrezno podprte z glavno dokumentacijo ali ustreznimi podatki ter v skladu z zahtevami Evropske farmakopeje.
A harmonised European approach to supply has been in place since identification of the concern at Castlebar and the article 31 procedure remains ongoing pending resolution of the outstanding issues.
Usklajen evropski pristop do oskrbe je vzpostavljen od ugotovitve, da obstajajo težave glede obrata v Castlebaru, postopek po členu 31 pa bo potekal, dokler odprta vprašanja ne bodo rešena.
In particular, the peritoneal dialysis (PD) Dianeal, Extraneal and Nutrineal were affected by this procedure.
Ta postopek zadeva predvsem zdravila Dianeal, Extraneal in Nutrineal, namenjena za peritonealno dializo (PD).
• The review of the issues identified at Castlebar is ongoing, and peritoneal dialysis solutions are not being released from this manufacturing plant which is the main marketing authorisation holder's supplier in Europe.
• Pregled težav, ugotovljenih v Castlebaru, še poteka, raztopine za peritonealno dializo pa se iz tega proizvodnega obrata, ki je glavni dobavitelj imetnika dovoljenja za promet z zdravilom za Evropo, ne dobavljajo.
At this stage of the article 31 procedure, sufficient data is available to recommend the variation to the marketing authorisations consisting in the inclusion of the site located in the USA as additional manufacturing site, as no major quality issues were identified.
V tej fazi postopka v skladu s členom 31 je na voljo dovolj podatkov, da se priporoči sprememba dovoljenj za promet z zdravilom, in sicer vključitev proizvodnega obrata v ZDA kot dodatnega proizvodnega obrata, saj v njem niso ugotovili nobenih večjih težav s kakovostjo.
Overall summary of the scientific evaluation on the inclusion of an additional site into the existing licenses of dialysis solutions (Dianeal PD4 and Extraneal) from Baxter group of companies and associated companies (see Annex I)
Splošni povzetek znanstvenega vrednotenja vključitve dodatnega proizvodnega obrata v obstoječe licence za dializne raztopine (Dianeal PD4 in Extraneal) skupine družb Baxter in povezanih družb (glejte Prilogo I)
Taking into account the crucial nature of these medicinal products, unaffected batches of PD solutions had to be made available to patients across the EU in the shortest possible timeframe, and thus alternatives were sought.
Ob upoštevanju pomena teh zdravil so morale biti enake serije raztopin za PD v najkrajšem možnem času na voljo bolnikom po vsej EU, zaradi česar so se iskala nadomestna zdravila.
In view of severe supply limitations for Dianeal, Extraneal and Nutrineal and the risk of switching patients to alternative PD solutions or therapies, the CHMP considered that the use of comparable products produced by Baxter at alternative manufacturing sites outside the EEA (European Economic Area) should be prioritised.
Zaradi velikih omejitev dobave zdravil Dianeal, Extraneal in Nutrineal ter tveganja pri bolnikih zaradi zamenjave zdravila z nadomestnimi raztopinami ali terapijami za PD je CHMP menil, da je uporaba primerljivih zdravil, ki jih proizvaja družba Baxter v drugih proizvodnih obratih izven EGP (Evropski gospodarski prostor), prednostna.
• The CHMP considers that sufficient quality data is available to recommend the inclusion of the manufacturing site located in the USA into the existing marketing authorisations for the peritoneal dialysis solutions, as applicable.
• CHMP meni, da so na voljo zadostni podatki o kakovosti, da lahko priporoči vključitev proizvodnega obrata v ZDA v obstoječa dovoljenja za promet z zdravilom za raztopine za peritonealno dializo, če je to smiselno.
The opinion on the Castlebar site cannot be finalised at this stage as issues remain for resolution by the marketing authorisation holder.
Mnenje glede proizvodnega obrata v Castlebaru ne more biti dokončno, saj so v tej fazi še vedno odprta nekatera vprašanja, ki jih mora rešiti imetnik dovoljenja za promet z zdravilom.
In April 2011, the Committee considered that sufficient information was available to issue a first opinion for this Article 31 procedure recommending the addition of Canada, Poland and Turkey manufacturing sites to the existing PD solutions' marketing authorisations.
Odbor je aprila 2011 menil, da je na voljo dovolj informacij za izdajo prvega mnenja o postopku v skladu s členom 31, ki priporoča, da se v obstoječa dovoljenja za promet z raztopinami za PD dodajo proizvodni obrati v Kanadi, na Poljskem in v Turčiji.
• The CHMP considered the referral under Article 31 of Directive 2001/83/EC, as amended, for dialysis solutions from Baxter group of companies and associated companies produced at Castlebar.
• CHMP je proučil napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za raztopine za dializo skupine družb Baxter in povezanih družb, proizvedene v Castlebaru.
In light of the current uncertainty over the root cause and the future re-instatement of supply from Castlebar, the addition of manufacturing sites to the marketing authorisations aimed at mitigating future supply problems arising for PD solutions in Europe, ensuring that sufficient PD solutions are available.
Zaradi trenutne negotovosti glede glavnega vzroka in ponovne vzpostavitve dobave iz Castlebara v prihodnje je dodajanje proizvodnih obratov v dovoljenja za promet z zdravilom namenjeno reševanju prihodnjih težav z dobavo raztopin za PD v Evropi ter zagotavljanju razpoložljivosti zadostnih raztopin za PD.
- Water for injections, and other excipients, should fully comply with Ph Eur monograph requirements, where applicable.
- Voda za injekcije in druge pomožne snovi morajo biti popolnoma v skladu z zahtevami Evropske farmakopeje, kjer je primerno.
Pending conclusion of the ongoing Article 31, it is expected that the MAH implements in all its sites the outcome of lessons learned from the findings at Castlebar, to ensure a safe product supply.
Glede na zaključek postopka po členu 31 se pričakuje, da bo imetnik dovoljenja za promet z zdravilom v vseh proizvodnih obratih upošteval pridobljene izkušnje in ugotovitve iz obrata v Castlebaru in tako zagotovil oskrbo z varnim zdravilom.
Standard QP release should apply for all products released under the terms of EU marketing authorisations; in particular the QPs must be satisfied that the active substances are manufactured in accordance with EU GMP requirements.
Standardna usposobljenost za proizvodnjo (QP) se mora uporabljati za vsa zdravila, ki se izdajajo v skladu s pogoji dovoljenj za promet z zdravili v EU; izpolnjeni morajo biti zlasti standardi usposobljenosti za proizvodnjo glede proizvajanja zdravilnih učinkovin v skladu z zahtevami dobre proizvodne prakse (GMP) v EU.
• Unaffected batches of peritoneal dialysis solutions needed to be made available to patients across the EU in the shortest possible timeframe, thus alternative PD solutions produced by Baxter at alternative manufacturing sites outside the EEA (European Economic Area) were prioritised.
• Za bolnike po vsej EU je bilo treba v najkrajšem možnem času zagotoviti enake raztopine za peritonealno dializo, zaradi česar so bile nadomestne raztopine za PD, proizvedene v drugih obratih družbe Baxter izven EGP (Evropski gospodarski prostor), prednostne.
An article 31 referral procedure of Directive 2001/83/EC, as amended was initiated by the European Commission (EC) following reports of out-of-specifications results for endotoxins in dialysis solutions from Baxter group of companies and associated companies produced at Castlebar.
Napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, je sprožila Evropska komisija po poročanju o rezultatih izven specifikacijskih meja za endotoksine v dializnih raztopinah skupine družb in povezanih družb Baxter, proizvedenih v Castlebaru.
Whilst all data to finalise the ongoing article 31 is not available, a stepwise approach is followed for the assessment, resulting in subsequent opinions being adopted by the CHMP.
Dokler ne bodo na voljo vsi podatki za dokončanje postopka po členu 31, bo vrednotenje in posledično izdajanje mnenj CHMP potekalo postopoma.
Therefore, without prejudice to the ongoing article 31 procedure, the CHMP considers that sufficient information is available to issue a second opinion for this Article 31 procedure recommending the addition of the USA manufacturing site to the relevant PD solutions' marketing authorisations, subject to conditions set out in the Annex IV.
Zato CHMP ne glede na potekajoči postopek v skladu s členom 31 meni, da je na voljo dovolj podatkov za izdajo drugega mnenja o tem postopku iz člena 31, ki priporoča dodajanje proizvodnega obrata v ZDA v zadevna dovoljenja za promet z raztopinami za PD v skladu s pogoji, navedenimi v Prilogi IV. Na splošno je treba upoštevati naslednje:
the CHMP recommends the variation to the terms of the marketing authorisations concerning the addition of the manufacturing site in the USA and for which the relevant amendments to sections of the summaries of product characteristics and package leaflets are set out in Annex III for dialysis solutions from Baxter group of companies and associated companies produced at Castlebar (see Annex I).
CHMP priporoča spremembo pogojev za dovoljenja za promet z zdravilom v zvezi z dodajanjem proizvodnega obrata v ZDA, katerih ustrezna dopolnila poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo raztopin za peritonealno dializo skupine družb Baxter in povezanih družb, proizvedenih v Castlebaru (glejte Prilogo I), so navedena v Prilogi III.
The review of the issues identified at Castlebar, with the interruption of supply from this site, led to the need to authorise additional manufacturing sites to ensure supply of PD solutions in Europe.
Pregled težav, odkritih v proizvodnem obratu Castlebar, in motnje z dobavo s tega proizvodnega obrata so vodili do potrebe po odobritvi dodatnega proizvodnega obrata, ki bi zagotovil oskrbo z raztopinami za PD po Evropi.