natgillin/translations-raw huggingface dataset:
The basis for the notification was a suspected adverse reaction report received in The Netherlands after a veterinarian accidentally injected himself with the product Sedivet, which contains romifidine as the active ingredient. 
Podlaga za obvestilo je bilo poročilo o sumu na neželene učinke, ki je bilo prejeto na Nizozemskem po tem, ko si je veterinar po nesreči vbrizgal zdravilo Sedivet, ki kot zdravilno učinkovino vsebuje romifidin.
OPINION FOLLOWING AN ARTICLE 781 PROCEDURE FOR Veterinary medicinal products containing Alpha2-adrenoreceptor agonists2 
MNENJE V ZVEZI S POSTOPKOM V SKLADU S ČLENOM 781 ZA zdravila za uporabo v veterinarski medicini, ki vsebujejo agoniste adrenergičnih receptorjev alfa22
Written responses were received by Marketing Authorisation Holders for 81 of the 108 notified authorisations held by a total of 66 Marketing Authorisation Holders by 16 September 2008. 
Imetniki dovoljenj za promet z zdravilom so do 16. septembra 2008 prejeli pisne odgovore za 81 od 108 priglašenih dovoljenj za promet z zdravilom, ki jih je imelo 66 imetnikov dovoljenj za promet z zdravilom.
In accordance with Article 78(3) of Directive 2001/82/EC, as amended, the Committee for Medicinal Products for Veterinary Use (CVMP) is to give its opinion on the conclusions and intended risk management measures presented by the notifying Authority which in this procedure was the Dutch Medicines Evaluation Board. 
V skladu s členom 78(3) Direktive 2001/82/ES, kakor je bila spremenjena, mora Odbor za zdravila za uporabo v veterinarski medicini (CVMP) podati svoje mnenje o zaključkih in predlaganih ukrepih obvladovanja tveganj, ki jih je predstavil organ priglasitelj, kar je bil v tem postopku nizozemski odbor za ocenjevanje zdravil.
On 13 September 2006 the procedure was initiated by adoption of a list of questions to be put to the concerned Marketing Authorisation Holders. 
Postopek se je začel 13. septembra 2006 s sprejetjem seznama vprašanj za zadevne imetnike dovoljenj za promet z zdravilom.
Member States identified and informed the Agency of the concerned marketing authorisations in their respective territories. 
Države članice so identificirale zadevna dovoljenja za promet z zdravilom na svojih ozemljih in o tem obvestile Agencijo.
The concerned Marketing Authorisation Holders were informed accordingly by a letter dated 13 December 2006. 
Zadevni imetniki dovoljenj za promet z zdravilom so bili ustrezno obveščeni z dopisom z dne 13. decembra 2006.
Following further communication with the European Commission in years 2007 and 2008 on the opinion and the scope of the procedure, the CVMP in the July 2008 plenary meeting agreed to complete the procedure under Article 78 of Directive 2001/82/EC, as amended, for all marketing authorisations held in the EU for the 21 products containing alpha2-adrenoreceptor agonists initially notified and to revise the initial opinion accordingly. 
CVMP se je po nadaljnjem posvetovanju z Evropsko komisijo v letih 2007 in 2008 glede mnenja in obsega postopka na plenarnem zasedanju v juliju 2008 strinjal, da bo zaključil postopek v skladu s členom 78 Direktive 2001/82/ES, kakor je bila spremenjena, za vsa že priglašena dovoljenja za promet z zdravilom v EU za 21 zdravil, ki vsebujejo agoniste adrenergičnih receptorjev alfa2, ter da bo skladno s tem ponovno pregledal prvotno mnenje.
A revised list of questions addressed to the concerned Marketing Authorisation Holders was adopted on 16 July 2008. 
Dne 16. julija 2008 je bil sprejet revidiran seznam vprašanj, naslovljen na zadevne imetnike dovoljenj za promet z zdravilom.
The College Ter Beoordeling van Geneesmiddelen (Medicines Evaluation Board, The Netherlands), in accordance with Article 78(1) of Directive 2001/82/EC, as amended by Directive 2004/28/EC, informed the EMEA by a letter dated 25 August 2006 of its intention to vary the marketing authorisation and to add a new precautionary measure for 21 veterinary medicinal products containing alpha2-adrenoreceptor agonists authorised in The Netherlands. 
Fakulteta Ter Beoordeling van Geneesmiddelen (Odbor za ocenjevanje zdravil, Nizozemska) je z dopisom z dne 25. avgusta 2006 skladno s členom 78(1) Direktive 2001/82/ES, kakor je bila spremenjena z Direktivo 2004/28/ES, obvestila agencijo EMEA o svojem namenu, da bo spremenila dovoljenje za promet z zdravilom in dodala nov previdnostni ukrep za 21 zdravil za uporabo v veterinarski medicini, odobrenih na Nizozemskem, ki vsebujejo agoniste adrenergičnih receptorjev alfa2.
The Committee considered that specific precautionary measures should be reflected in the product literature of concerned products containing alpha2-agonists. 
Odbor je menil, da morajo biti v gradivu zadevnih zdravil, ki vsebujejo agoniste adrenergičnih receptorjev alfa2, navedeni posebni previdnostni ukrepi .
The extrapolation of the proposed warnings for one alpha2-adrenoreceptor agonist to other alpha2adrenoreceptor agonists was considered justified, since the pharmacological mode of action is the same and because several of the substances have shown similar effects in humans. 
Predlagatelj je menil, da je uporaba opozoril, ki so bila predlagana za enega od agonistov adrenergičnih receptorjev alfa2, tudi pri drugih agonistih adrenergičnih receptorjev alfa2 upravičen, ker imajo te snovi enak farmakološki način delovanja in ker je več teh snovi pokazalo podobne učinke pri ljudeh.
1 Article 78 of Directive 2001/82/EC, as amended See Annex I for the complete list of concerned products 
1 Člen 78 Direktive 2001/82/ES, kakor je bila spremenjena.
Written explanations were provided by the Marketing Authorisation Holders on 13 October 2006. 
Imetniki dovoljenj za promet z zdravilom so predložili pisne razlage dne 13. oktobra
1 vial + 1 vial 
1 viala + 1 viala
0.9 mg Powder and solvent for solution for injection 
0,9 mg Prašek in vehikel za raztopino za injiciranje
powder: 3 ml solvent: 5 ml 
prašek: 3 ml vehikel: 5 ml
Intralesional use powder: vial (glass) solvent: vial (glass) 
Intralezijska uporaba prašek: viala (steklena) vehikel: viala (steklena)
Package size 
velikost pakiranja
Content (concentration) 
(Izmišljeno) ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
Outcome of a procedure under Article 33(4) of Directive 2001/82/EC, as amended 
Izid postopka v skladu s členom 33(4) Direktive 2001/82/ES, kakor je bila spremenjena
The European Commission issued a decision on 28 August 2015. 
Evropska komisija je sklep izdala 28. avgusta 2015.
The company wanted the authorisation to be recognised in other EU Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and the United Kingdom). 
Družba je želela, da bi bilo dovoljenje za promet z zdravilom priznano v drugih državah članicah EU (v zadevnih državah članicah, ki so v tem primeru Avstrija, Belgija, Bolgarija, Hrvaška, Ciper, Češka republika, Estonija, Finska, Nemčija, Grčija, Islandija, Irska, Italija, Latvija, Litva, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Švedska in Združeno kraljestvo).
What are the conclusions of the CVMP? 
Kakšni so zaključki odbora CVMP?
Veterinary Medicines Division 
Oddelek za zdravila za uporabo v veterinarski medicini
However, the Member States were not able to reach an agreement and the National Food Chain Safety Office of Hungary referred the matter to the CVMP for arbitration on 24 October 2014. 
Vendar države članice niso mogle doseči soglasja, zato je madžarski nacionalni urad za varnost prehrambne verige 24. oktobra 2014 zadevo napotil na odbor CVMP v arbitražo.
On 3 June 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Coglapix suspension for injection for pigs. 
Evropska agencija za zdravila je 3. junija 2015 zaključila arbitražni postopek, do katerega je prišlo zaradi nesoglasja med državami članicami Evropske unije (EU) glede izdaje dovoljenja za promet z zdravilom Coglapix suspenzija za injiciranje za prašiče.
The grounds for the referral were concerns raised by Italy that the efficacy of Coglapix has not been adequately demonstrated, that the benefit of the vaccine under practical conditions of use has not been demonstrated and that the results obtained from duration of immunity studies were inconsistent. 
Razlog za napotitev so bili pomisleki Italije v zvezi s tem, da učinkovitost zdravila Coglapix ni bila ustrezno dokazana, da korist cepiva v praktičnih pogojih uporabe ni bila dokazana in da so med študijami trajanja imunosti pridobili nasprotujoče si rezultate.
The vaccine is intended for active immunisation of pigs against pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, in order to reduce the clinical signs and lung lesions associated with the disease. 
Namenjeno je aktivni imunizaciji prašičev proti plevropnevmoniji, ki jo povzročata serotipa 1 in 2 A. pleuropneumoniae, s čimer se zmanjšajo klinični znaki in pljučne lezije, povezani s to boleznijo.
The vaccine contains five formaldehyde-inactivated strains of Actinobacillus pleuropneumoniae. 
Cepivo vsebuje pet s formaldehidom inaktiviranih sevov bacila Actinobacillus pleuropneumoniae.
The product information for Coglapix in Hungary should also be amended. 
Spremeniti je treba tudi informacije o zdravilu Coglapix na Madžarskem.
Ceva-Phylaxia Veterinary Biologicals Co. Ltd. submitted an application for Coglapix for mutual recognition on the basis of the initial authorisation granted by Hungary. 
Družba Ceva-Phylaxia Veterinary Biologicals Co. Ltd. je predložila vlogo za medsebojno priznavanje zdravila Coglapix na podlagi prvotnega dovoljenja za promet, izdanega na Madžarskem.
Hence, the relevant sections of the Summary of Product Characteristics and package leaflet should be amended in order to reflect this. 
Zadevna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo je treba zato ustrezno spremeniti.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Coglapix outweigh its risks, and the marketing authorisation granted in Hungary can be recognised in other Member States of the EU (see below). 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Coglapix večje od z njim povezanih tveganj ter da se lahko dovoljenje za promet, izdano na Madžarskem, prizna v drugih državah članicah EU (gl. spodaj).
Therefore, based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the benefits of Coglapix outweigh its risks, and recommended that the marketing authorisation be granted in all concerned Member States. 
Odbor CVMP je glede na oceno trenutno razpoložljivih podatkov in znanstveno razpravo znotraj odbora sklenil, da koristi zdravila Coglapix odtehtajo z njim povezana tveganja, in priporočil, da se dovoljenje za promet izda v vseh zadevnih državah članicah.
Based on the data presented it was concluded that following vaccination of pigs with Coglapix reduction of clinical signs and lung lesions associated with the disease has been demonstrated in laboratory efficacy studies, although some concerns on the statistical significance of the results still remain. 
Na podlagi predloženih rezultatov je odbor zaključil, da so po cepljenju prašičev z zdravilom Coglapix v laboratorijskih študijah učinkovitosti dokazali zmanjšanje kliničnih znakov in pljučnih lezij, povezanih s to boleznijo, čeprav so še vedno prisotni pomisleki glede statistične pomembnosti rezultatov.
The CVMP also recommended that the product information for the medicine in Hungary be amended. 
Priporočil je tudi, da se informacije o tem zdravilu na Madžarskem spremenijo.
Duration of immunity was established for both serotypes (1 and 2) up to 16 weeks after vaccination according to the results of relevant challenge studies. 
Glede na rezultate provokacijskih študij je bilo za oba serotipa (1 in 2) ugotovljeno trajanje imunosti do 16 tednov po cepljenju.
Why was Coglapix suspension for injection for pigs reviewed? 
Zakaj je bilo zdravilo Coglapix suspenzija za injiciranje za prašiče pregledano?
Coglapix is an inactivated bacterial vaccine against porcine actinobacillosis. 
Zdravilo Coglapix je inaktivirano bakterijsko cepivo proti prašičji aktinobacilozi.
What is Coglapix suspension for injection for pigs? 
Kaj je zdravilo Coglapix suspenzija za injiciranje za prašiče?
10 vials (multidose: 10 doses) 
10 vial (večkratni odmerek:
Content (concentration) Pack size 
Vsebina (koncentracija)
10 vials (monodose) 
10 vial (enkratni odmerek)
Route of administration 
Pot uporabe Stična ovojnina
10785 Berlin Germany 
10785 Berlin Nemčija
243 Messoghion Avenue 154 51 Neo Psychico Greece 
243 Messoghion Avenue 154 51 Neo Psychico Grčija
28700 San Sebastián de los Reyes (Madrid), Spain 
28700 San Sebastián de los Reyes (Madrid), Španija
Via Nettunense, 90 Aprilia (LT), 04011, Italy 
Via Nettunense, 90 Aprilia (LT), 04011, Italija
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States 
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
Arquiparque - Miraflores 1495-131 ALGÉS Portugal 
Arquiparque - Miraflores 1495-131 ALGÉS Portugalska
Rivium westlaan 142 2909 LD Capelle a/d IJssel The Netherlands 
Rivium westlaan 142 2909 LD Capelle a/d IJssel Nizozemska
Boulevard de la Plaine 17 1050 Brussels Belgium 
Boulevard de la Plaine 17 1050 Brussels Belgija
Vetenskapsvägen 10 191 90 Sollentuna, Sweden 
Vetenskapsvägen 10 191 90 Sollentuna, Švedska
Berkshire SL6 0PH United Kingdom 
Berkshire SL6 0PH Velika Britanija
John Wyeth & Brother Limited (trading as Wyeth Pharmaceuticals) Huntercombe Lane South Taplow, Maidenhead, Berks, SL6 0PH United Kingdom 
John Wyeth & Brother Limited (trading as Wyeth Pharmaceuticals) Huntercombe Lane South Taplow, Maidenhead, Berks, SL6 0PH Velika Britanija
Stroupežnického 3191/17, 150 00 Praha Smíchov Czech Republic 
Stroupežnického 3191/17, 150 00 Praha Smíchov Češka
Stroupežnického 3191/17, 150 00 Praha Smíchov, Czech Republic 
Stroupežnického 3191/17, 150 00 Praha Smíchov, Češka
4 g piperacillin equivalent to 4.17 g piperacillin sodium 
4 g piperacilina, ki ustreza 4,17 g natrijeve soli piperacilina
0.5 g tazobactam equivalent to 0.5366 g tazobactam sodium 
0.5 g tazobaktama, ki ustreza 0,5366 g natrijeve soli tazobaktama
2,085 g sodium piperacillin + 268,30 mg sodium tazobactam 
2,085 g natrijeve soli piperacilina + 268,30 mg natrijeve soli tazobaktama
TAZOCIN 4g/0.5g contains 2 active ingredients; piperacillin 4g and tazobactam 0.5g both present as sodium salts. 
TAZOCIN 4g/0,5g vsebuje 2 zdravilni učinkovini; piperacilin 4 g in tazobaktam 0,5 g, obe v obliki natrijeve soli.
TAZOCIN 4,5 g prašek za raztopino za injiciranje ali infundiranje 
TAZOCIN 4 g / 0,5 g prašek za raztopino za injiciranje ali infundiranje
TAZOCIN 2g/0.25g contains 2 active ingredients; piperacillin 2g and tazobactam 0.25g both present as sodium salts. 
TAZOCIN 2g/0,25g vsebuje 2 zdravilni učinkovini; piperacilin 2 g in tazobaktam 0,25 g, obe v obliki natrijeve soli.
4,170 g sodium piperacillin + 536,60 mg sodium tazobactam 
4,170 g natrijeve soli piperacilina + 536,60 mg natrijeve soli tazobaktama
4000m g+500mg g 
4000mg +500mg g
1 injection vial contains piperacillin sodium equivalent to 4.0g of piperacillin and tazobactam sodium equivalent to 0.5g of tazobactam. 
1 viala vsebuje natrijevo sol piperacilina, ki ustreza 4,0 g piperacilina in natrijevo sol tazobaktama, ki ustreza 0,5 g tazobaktama
Intravenous use 2 g piperacillinum / 0,25 g tazobactamum 
2 g piperacilina / 0,25 g tazobaktama
0.5366 g tazobactam sodium equivalent to 0.500 g tazobactam and 4.170 g piperacillin sodium equivalent to 4.00 g piperacillin 
0,5366 g natrijeve soli tazobaktama, ki ustreza 0,500 g tazobaktama in 4,170 g natrijeve soli piperacilina, ki ustreza 4,00 g piperacilina
4 g piperacillin (in form of piperacillin sodium) and 0,5 g tazobactam (in form of tazobactam sodium). 
4 g piperacilina (v obliki natrijeve soli piperacilina) in 0,5 g tazobaktama (v obliki natrijeve soli tazobaktama)
2 g piperacillin (in form of piperacillin sodium) and 0,25 g tazobactam (in form of tazobactam sodium). 
2 g piperacilina (v obliki natrijeve soli piperacilina) in 0,25 g tazobaktama (v obliki natrijeve soli tazobaktama)
Piperacillin 2g and tazobactam250mg both present as sodium salts. 
2 g piperacilina in 250 mg tazobaktama, oba v obliki natrijeve soli
Tazocin 2,25 g, liofilizat pentru soluţie injectabilă/ perfuzabilă 
Tazocin 2,25 g, liofilizat pentru soluţie injectabilă/ perfuzabilă liofilizirani prašek za raztopino za injiciranje ali infundiranje
Tazocin 4,5 g, liofilizat pentru soluţie injectabilă/ perfuzabilă 
Tazocin 4,5 g, liofilizat pentru soluţie injectabilă/ perfuzabilă liofilizirani prašek za raztopino za injiciranje ali infundiranje
Intravenous use 4 g piperacillinum / 0,5 g tazobactamum 
4 g piperacilina / 0,5 g tazobaktama
Sodium piperacillin and sodium tazobactam, equivalent to 4 g piperacillin and 500 mg tazobactam 
4 g/500mg prašek za raztopino za injiciranje natrijeva sol piperacilina in natrijeva sol tazobaktama, ki ustrezata 4 g piperacilina in 500 mg tazobaktama
2.085 g sodium piperacillin equivalent to 2 g piperacillin and 0.2683 g sodium tazobactam equivalent to 0.250 g tazobactam. 
2,085 g natrijeve soli piperacilina, ki ustreza 2 g piperacilina in 0,2683 g natrijeve soli tazobaktama, ki ustreza 0,250 g tazobaktama
Sodium piperacillin 2.085 g sodium tazobactam 268.300 mg 
2g/250mg prašek za raztopino za infundiranje infuzija natrijeva sol piperacilina 2,085 g natrijeva sol tazobaktama 268,300 mg
Piperacillin (in the form of piperacillin sodium) 4 g Tazobactam (in the form of tazobactam sodium) 0.50 g 
Tazocel 4/0,5 g Polvo para solución inyectable piperacilin (v obliki natrijeve soli piperacilina) 4 g in tazobaktam (v obliki natrijeve soli tazobaktama) 0,50 g
2g piperacillin and 0.25g tazobactam (both present as sodium salts). 
2 g piperacilina in 0,25 g tazobaktama (oba v obliki natrijeve soli)
2.085 g of piperacillin sodium equivalent to 2 g of piperacillin and 0.2683 g of tazobactam sodium equivalent to 250 mg of tazobactam 
2,085 g natrijeve soli piperacilina, ki ustreza 2 g piperacilina in 0,2683 g natrijeve soli tazobaktama, ki ustreza 250 mg tazobaktama
Piperacillin (in the form of piperacillin sodium) 2 g Tazobactam (in the form of tazobactam sodium) 0.25 g 
2/0,25 g prašek za raztopino za injiciranje piperacilin (v obliki natrijeve soli piperacilina) 2 g in tazobaktam (v obliki natrijeve soli tazobaktama) 0,25 g
Sodium piperacillin 4.170 g sodium tazobactam 536.600 mg 
4g/500mg prašek za raztopino za infundiranje infuzija natrijeva sol piperacilina 4,170 g natrijeva sol tazobaktama 536,600 mg
4g piperacillin and 0.5g tazobactam (both present as sodium salts). 
4 g piperacilina in 0,5 g tazobaktama (oba v obliki natrijeve soli)
Piperacillin 
Ciper
4.17 g sodium piperacillin equivalent to 4 g piperacillin and 0.5366 g sodium tazobactam equivalent to 0.5 g tazobactam. 
4,17 g natrijeve soli piperacilina, ki ustreza 4 g piperacilina in 0,5366 g natrijeve soli tazobaktama, ki ustreza 0,5 g tazobaktama
Trockenstechampullen 4,0 g/0,5 g Lyophilisate for solution for injection or infusion 
Tazonam 4,0 g/0,5 gTrockenstechampullen 4,0 g/0,5 g liofilizat za raztopino za injiciranje ali infundiranje
4,170 g piperacillin sodium equivalent to 4000 mg of piperacillin and 0.5366 g tazobactam sodium equivalent to 500 mg of tazobactam. 
4,170 g natrijeve soli piperacilina, ki ustreza 4000 mg piperacilina in 0,5366 g natrijeve soli tazobaktama, ki ustreza 500 mg tazobaktama
Powder for solution for injection and infusion contains 2.085g piperacillin sodium equivalent to 2g piperacillin and 0.2683 g tazobactam sodium equivalent to 250 milligrams tazobactam 
Tazocin 2,25g vsebuje 2,085 g natrijeve soli piperacilina, ki ustreza 2 g piperacilina in 0,2683 g natrijeve soli tazobaktama, ki ustreza 250 mg tazobaktama
4.170 g piperacillin sodium equivalent to 4 g piperacillin and 0.5366 g tazobactam sodium equivalent to 500 mg tazobactam. 
4,170 g natrijeve soli piperacilina, ki ustreza 4 g piperacilina in 0,5366 g natrijeve soli tazobaktama, ki ustreza 500 mg tazobaktama
Sodium piperacillin and sodium tazobactam, equivalent to 2 g piperacillin and 250 mg tazobactam. 
Tazocin® 2 g/ 250 mg 2g /250 mg prašek za raztopino za injiciranje natrijeva sol piperacilina in natrijeva sol tazobaktama, ki ustrezata 2 g piperacilina in 250 mg tazobaktama
2g/250 mg Powder for Solution for Injection or Infusion 
2g/250 mg prašek za raztopino za injiciranje
Piperacillin sodium corresponding to piperacillin 2 g and tazobactam sodium corresponding to tazobactam 0,25 g 
1324 Lysaker Norveška natrijeva sol piperacilina, ki ustreza 2 g piperacilina, natrijeva sol tazobaktama, ki ustreza 0,25 g tazobaktama
This overview was last updated in 05-2018. 
Pregled je bil nazadnje posodobljen 05-2018.
Further information on Ivemend can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Več informacij o zdravilu Ivemend je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Ivemend? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ivemend?
This means that it is converted to aprepitant in the body. 
To pomeni, da se šele v telesu pretvori v aprepitant.
Aprepitant has been authorised in the European Union (EU) as Emend since 2003. 
Aprepitant je v Evropski uniji (EU) odobren od leta 2003 kot zdravilo Emend.
What benefits of Ivemend have been shown in studies? 
Kakšne koristi zdravila Ivemend so se pokazale v študijah?
The European Medicines Agency therefore decided that Ivemend's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Ivemend večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What is Ivemend and what is it used for? 
Kaj je zdravilo Ivemend in za kaj se uporablja?
Ivemend received a marketing authorisation valid throughout the EU on 11 January 2008. 
Za zdravilo Ivemend je bilo 11. januarja 2008 izdano dovoljenje za promet, veljavno po vsej EU.
Other information about Ivemend 
Druge informacije o zdravilu Ivemend
Why is Ivemend authorised in the EU? 
Zakaj je bilo zdravilo Ivemend odobreno v EU?
An overview of Ivemend and why it is authorised in the EU 
Pregled zdravila Ivemend in zakaj je odobreno v EU
In children it may be given on the first day or on multiple days through a tube inserted into a large vein near the heart. 
Pri otrocih se lahko daje prvi dan ali več dni zapored po cevki, vstavljeni v veliko veno blizu srca.
As for all medicines, data on the use of Ivemend are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ivemend stalno spremljajo.
What are the risks associated with Ivemend? 
Kakšna tveganja so povezana z zdravilom Ivemend?
It contains the active substance fosaprepitant. 
Vsebuje učinkovino fosaprepitant.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivemend have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ivemend upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Aprepitant is a neurokinin 1 (NK1) receptor antagonist. 
Aprepitant je zaviralec receptorjev za nevrokinin 1 (NK1).