natgillin/translations-raw huggingface dataset:
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER FOR 100 MG FILM-COATED TABLETS 
PERFORIRANI ENOODMERNI PRETISNI OMOT ZA 100 MG FILMSKO OBLOŽENE TABLETE
Pruritus Rash Common Dry skin 
Pogosti Suha koža
Dose modification is recommended for patients who develop ≥ Grade 2 diarrhoea (see section 4.2). 
Pri bolnicah, pri katerih se pojavi driska stopnje 2 ali višje, je priporočljivo prilagoditi odmerek (glejte poglavje 4.2).
Very common Neutropenia Leukopenia Anaemia Thrombocytopenia Common Lymphopenia Uncommon Febrile neutropenia 
Žilne bolezni Pogosti Venska trombembolijac Bolezni prebavil Zelo pogosti Driska Bruhanje Slabost Bolezni kože in podkožja Zelo pogosti Alopecija Pruritus
Verzenios 50 mg film-coated tablets 
KOLEDARSKI PRETISNI OMOT ZA 50 MG FILMSKO OBLOŽENE TABLETE
Gastrointestinal disorders 
Trombocitopenija Pogosti
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER FOR 50 MG FILM-COATED TABLETS 
PERFORIRANI ENOODMERNI PRETISNI OMOT ZA 50 MG FILMSKO OBLOŽENE TABLETE
Objective response rateb [%] (95% CI) 
[%] (95 % IZ)
Investigator assessment, number of events 
Neodvisni radiografski pregled, število dogodkov (%)
Sat. 
bolnic.
In patients who were pre/perimenopausal, the hazard ratio was 0.415 (95% CI: 
Zmanjšanje tveganja za napredovanje bolezni ali smrt so opazili pri bolnicah z visceralno boleznijo (HR 0,567 [95 % IZ:
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER FOR 150 MG FILM-COATED TABLETS 
PERFORIRANI ENOODMERNI PRETISNI OMOT ZA 150 MG FILMSKO OBLOŽENE TABLETE
Verzenios 100 mg film-coated tablets 
KOLEDARSKI PRETISNI OMOT ZA 100 MG FILMSKO OBLOŽENE TABLETE
These measures should help to protect the environment. 
Ti ukrepi pomagajo varovati okolje
Date of first authorisation: 24/07/2009 Date of last renewal: 06/06/2014 
Datum pridobitve dovoljenja za promet: 24/07/2009 Datum zadnjega podaljšanja dovoljenja za promet: 06/06/2014
In case of such reactions, appropriate treatment is recommended. 
V takih primerih se priporoča ustrezno zdravljenje.
ATC Vet Code: QI09AA07 
Oznaka ATC vet: QI09AA07
The benefit of the vaccination of pigs with very high levels of maternally-derived antibodies, e.g. due to vaccination of their mothers, has not been demonstrated. 
Korist cepljenja prašičev z zelo visokimi nivoji maternalnih protiteles, npr. zaradi cepljenja njihovih mater, ni bila dokazana.
Use vaccination devices according to the manufacturer's instructions. 
Naprave za cepljenje uporabite v skladu s proizvajalčevimi navodili za uporabo.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009. 
Učinkovina, ki je v osnovi biološkega izvora namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe (ES) št. 470/2009.
Store and transport refrigerated (2 °C - 8 °C). 
Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
The vaccine is to be administered aseptically. 
Cepivo je treba aplicirati aseptično.
Interactions with other medicinal products and other forms of interaction: 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij:
Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation. 
Vsakdo, ki namerava proizvajati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo, se mora najprej posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti prepovedane v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodnilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that: 
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove proizvajanje, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovi da:
a) The administration of the veterinary medicinal product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals. 
a) Bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
These clinical signs normally resolve without treatment. 
Običajno ti znaki minejo sami, brez zdravljenja.
One injection from 21 days of age. 
Ena injekcija po 21 dnevu starosti.
Lot {number} 
Lot {številka}
The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur. 
Področje lokalne tkivne reakcije je ponavadi manjše od 5 cm v premeru, vendar se lahko občasno pojavi večja oteklina.
Due to new field strains (PCV genotype), lack of expected efficacy (LEE) events should be submitted electronically on a yearly basis. 
Zaradi novih divjih sevov (PCV genotip), pomanjkanja pričakovane učinkovitosti (PPU) je treba dogodke oddati elektronsko in na letni osnovi.
b) The disease to which the product is intended to confer immunity is largely absent from the territory in question. 
b) Bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.
Vaccination schedule: 
Načrt cepljenja:
Pigs (piglets) from 3 weeks of age. 
Prašiči (pujski), starejši od 3 tednov.
It is intended to stimulate active immunity against PCV2 in piglets. 
Namenjen je stimulaciji aktivne imunosti proti PCV2 pri pujskih.
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
SPC so bodisi dovoljenje snovi, za katere, tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
Overdose (symptoms, emergency procedures, antidotes): 
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi):
Shelf life after first opening the immediate packaging: use immediately. 
Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
Single intramuscular injection of one dose (2 ml). 
Ena intramuskularna injekcija enega odmerka (2 ml).
50 doses 125 doses 
50 odmekov 125 odmerkov
Local tissue reactions in the form of swelling at the injection site are very common and may last for up to 26 days. 
Zelo pogosta je lokalna reakcija tkiva v obliki otekline na mestu injiciranja, ki lahko traja do 26 dni.
Special precautions for use in animals: Avoid stress in the animals before and after the time of vaccination. 
Posebni previdnostni ukrepi za uporabo pri živalih: Izogibajte se stresu pri živalih pred in po cepljenju.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the local requirements. 
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami.
0.1 mg * Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine. 
0,1 mg * Relativna Potenca enote določena s količino ELISA antigena (in vitro test potence) v primerjavi z referenčnim cepivom.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in plastenki.
Avoid stress in the animals before and after the time of vaccination. 
Izogibajte se stresu pri živalih pred in po cepljenju.
One dose of 2 ml contains: 
En odmerek po 2 ml vsebuje:
10 doses (20 ml) 
10 odmerkov (20 ml)
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Suspension for injection 
Suspenzija za injiciranje
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Vaccinate only healthy animals. 
Cepite samo zdrave živali.
Duration of immunity: 19 weeks post-vaccination. 
Trajanje imunosti: 19 tednov po cepljenju.
Name and address of the manufacturer of the biological active substance(s) 
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin)
Do not use in breeding boars. 
Ne uporabite pri plemenskih merjascih.
In clinical studies, a post-mortem examination of the injection site, performed 8 weeks after the administration of a single dose of the vaccine, revealed a mild to moderate granulomatous inflammation of the muscular fibres at the injection site. 
V kliničnih študijah je post-mortem pregled mesta injiciranja 8 tednov po aplikaciji enega odmerka cepiva pokazal blago do zmerno granulomatozno vnetje mišičnih vlaken na mestu injiciranja.
Cardboard box containing polyethylene bottles with a chlorobutyl elastomer closure and sealed with an aluminium cap. 
Kartonska škatla s polietilenskimi plastenkami s klorobutilnim elastomernim zamaškom zaščitenim z aluminijasto zaporko.
Shelf life of the veterinary medicinal product as package for sale: 2 years. 
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
CONTENTS BY WEIGHT, VOLUME OR BY NUMBER OF DOSES 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
The use of a multi-dosing syringe is recommended. 
Priporočljiva je uporaba brizge z večimi odmerki.
6 BATCH NUMBER 
6 ŠTEVILKA SERIJE
Immediate mild hypersensitivity-like reactions may occur commonly after vaccination, resulting in transient clinical signs such as vomiting. 
Takoj po cepljenju se lahko pogosto pojavijo blage reakcije, podobne preobčutljivostnim reakcijam, ki se kažejo s prehodnimi kliničnimi znaki kot je bruhanje.
Pharmacotherapeutic group: Immunologicals for suidae, inactivated viral vaccine. 
Farmakoterapevtska skupina: imunološka zdravila za prašiče (Suidae), inaktivirano virusno cepivo.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable 
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, ČE JE SMISELNO
Exceptionally, a large proportion of animals may react in some specific herds after vaccination. 
V izjemnih primerih se lahko v določenih čredah po cepljenju neželeni učinki pojavijo pri večini živali.
A transient increase in body temperature (up to 1.7 °C) is very common during the first 24 hours after vaccination. 
V prvih 24 urah po cepljenju je zelo pogosto prehodno povišanje telesne temperature (do 1,7 °C), ki spontano izgine v 48 urah brez zdravljenja.
Do not mix with any other veterinary medicinal product. 
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 21 days of age. 
Ena intramuskularna injekcija z enim odmerkom (2 ml) v vrat za uho prašičem starejšim od 21 dni.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports) 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
Onset of immunity: from 3 weeks post-vaccination. 
Nastop imunosti: od 3. tedna po cepljenju.
Administer one dose of 2 ml to piglets in the neck behind the ear. 
Odmerek po 2 ml aplicirajte pujsku v vrat za uho.
Intramuscular use 
intramuskularna uporaba
Zero days. 
Nič dni.
Active immunisation of pigs over the age of 3 weeks against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS). 
Aktivna imunizacija prašičev, starejših od 3 tednov, proti prašičjemu cirkovirusu tipa 2 (PCV2) za zmanjšanje kopičenja virusa v krvi in limfoidnem tkivu ter zmanjšanje lezij v limfoidnem tkivu, povezanih z infekcijo z PCV2, kot tudi za zmanjšanje kliničnih znakov - vključno z izgubo dnevnega prirasta in mortalnosti povezane povezane z multisistemskim sindromom hiranja po odstavitvi (PMWS).
A milky white to pink opaque liquid, free from visible particles 
Mlečno bela do rožnata motna tekočina, brez vidnih delcev.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo:
PACKAGE LEAFLET: Suvaxyn PCV suspension for injection for pigs 
NAVODILO ZA UPORABO: Suvaxyn PCV suspenzija za injiciranje za prašiče
Shake well before administration and intermittently during the process of vaccination. 
Pred dajanjem in večkrat med cepljenjem dobro pretresite.
Per dose of 2 ml: 
V 2 ml odmerku:
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE ZDRAVILA
Severe anaphylactic reactions are uncommon but may be lethal. 
Hude anafilaktične reakcije se pojavijo občasno, vendar so lahko smrtne.
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Store and transport refrigerated. 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku.
Adjuvants: 
Dodatki:
Specific pharmacovigilance requirements: 
D. DRUGI POGOJI IN ZAHTEVEDOVOLJENJA ZA PROMET Z ZDRAVILOM Posebne farmakovigilančne zahteve:
Major incompatibilities: Do not mix with any other veterinary medicinal product. 
InkompatibilnostiNe mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
Suvaxyn PCV suspension for injection for pigs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Suvaxyn PCV suspenzija za injiciranje za prašiče
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products, if appropriate 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil
MARKETING AUTHORISATION NUMBERS 
ŠTEVILKA() DOVOLJENJA ZA PROMET
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Boxes of 10 bottles of 10, 50 or 125 doses Boxes of 1 bottle of 10, 50 or 125 doses 
PODATKI NA ZUNANJI OVOJNINI Škatla z 10 plastenkami z 10, 50 ali 125 odmerki Škatla z 1 plastenko z 10, 50 ali 125 odmerki
Minimum Essential Medium without phenol red Sodium bicarbonate 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi tiomersal minimalni esencialni medij brez fenolnega rdečega natrijev bikarbonat hepes kislina voda za injekcije
Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein 1.6 ≤ RP ≤ 5.3 
KOLIČINA) UČINKOVIN(E) Inaktiviran rekombinanten prašičji cirkovirus tipa 1 z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2 1.6 ≤ RP ≤ 5.3
Special precautions to be taken by the person administering the veterinary medicinal product to animals 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo.
The vaccine strain is an inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein. 
Sev v cepivu je inaktiviran rekombinanten prašičji cirkovirus tipa 1 z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2.
MARKETING AUTHORISATION NUMBER(S) 
ŠTEVILKA(E) DOVOLJENJA ZA PROMET
Read the package leaflet before use. 
NAČIN IN POT(I) UPORABE Pred uporabo preberite navodilo za uporabo.
Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein 
Inaktiviran recombinanten prašičji cirkovirus tip 1 z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2
Pigs (piglets) 
CILJNE ŽIVALSKE VRSTE Prašiči (pujski).
Box of 1 bottle of 10 doses Box of 1 bottle of 50 doses Box of 1 bottle of 125 doses 
Škatla z 1 plastenko z 10 odmerki Škatla z 1 plastenko s 50 odmerki Škatla z 1 plastenko s 125 odmerki
Name and address of the manufacturer responsible for batch release 
Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
Cardboard box of 1 bottle of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml). 
Kartonska škatla z 1 plastenko z 10 odmerki (20 ml), 50 odmerki (100 ml) ali 125 odmerki (250 ml).
No adverse reactions except those mentioned in section 6 were observed after the administration of a double dose of vaccine. 
Po dajanju dvojnega odmerka cepiva ni bilo opaziti nobenih drugih neželenih učinkov kot tistih, opisanih v poglavju 6.
Box of 10 bottles of 10 doses Box of 10 bottles of 50 doses Box of 10 bottles of 125 doses 
Škatla z 10 plastenkami z 10 odmerki Škatla z 10 plastenkami s 50 odmerki Škatla z 10 plastenkami s 125 odmerki
Excipients: 
Učinkovina:
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju dvojnega odmerka cepiva ni bilo opaziti nobenih drugih neželenih učinkov kot tistih, opisanih v poglavju 4.6.
EXPIRY DATE 
EXP {mesec/leto}
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Zoetis Belgium SA
Pregnancy and lactation: Do not use during pregnancy and lactation. 
Ne uporabite v obdobju brejosti in laktacije.
EXP {month/year} Once broached use immediately. 
Načeto zdravilo uporabite takoj
Cardboard box of 10 bottles of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml). 
Kartonska škatla z 10 plastenkami z 10 odmerki (20 ml), 50 odmerki (100 ml) ali 125 odmerki
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle label 50 and 125 doses 
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Plastenka s 50 in 125 odmerki
QUANTITY OF THE ACTIVE SUBSTANCES 
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
- občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali).
Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1 
IMETNIK DOVOLJENJA ZA PROMET Zoetis Belgium SA
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label 10 doses 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 
NAVEDBA UČINKOVIN(E)
Outcome of a procedure under Article 13 of Regulation (EC) No 1234/2008 
Izid postopka v skladu s členom 13 Uredbe (ES) št. 1234/2008
1 A procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State. 
Postopek, po katerem odobritev zdravila v eni državi članici Evropske unije prizna druga država članica.
Why was Cardioxane reviewed? 
Zakaj je bilo zdravilo Cardioxane pregledano?
ANSM did not agree to the changes as requested by the company. 
Agencija ANSM se ni strinjala s spremembami, ki jih je vložila družba.
Its Committee for Medicinal Products for Human Use (CHMP) concluded that such a removal is acceptable. 
Njen Odbor za zdravila za uporabo v humani medicini (CHMP) je razsodil, da je odprava sprejemljiva.
Cardioxane is authorised under a ‘mutual recognition' procedure1 based on an initial authorisation granted by France. 
Zdravilo Cardioxane je bilo odobreno za promet po postopku medsebojnega priznavanja1 na podlagi prvotnega dovoljenja, ki ga je izdala Francija.
Cardioxane is authorised in the Czech Republic, Germany, France, Italy, the Netherlands, Poland, Spain and the United Kingdom. 
Zdravilo Cardioxane ima dovoljenje za promet na Češkem, v Nemčiji, Franciji, Italiji, na Nizozemskem, Poljskem, v Španiji in Združenem kraljestvu.
The company wanted the changes to be recognised in Czech Republic, Germany, France, Italy, the Netherlands, Poland, Spain and the United Kingdom (the ‘concerned Member States'). 
Družba je želela, da se spremembe dovoljenja za promet z zdravilom, priznajo na Češkem, v Nemčiji, Franciji, Italiji, na Nizozemskem, Poljskem in v Združenem kraljestvu („zadevne države članice“).
On 18 May 2017, the European Medicines Agency completed an arbitration procedure for Cardioxane (dexrazoxane powder for solution for injection). 
18. maja 2017 je Evropska agencija za zdravila končala postopek arbitraže za zdravilo Cardioxane (deksrazoksan prašek za raztopino za injiciranje).
What is Cardioxane? 
Kaj je zdravilo Cardioxane?
However, as there are a small number of patients under 18 years who require high doses of anthracyclines and who are therefore at greater risk of harmful effects on the heart, the Committee agreed that the contraindication should be lifted for this group. 
Ker pa obstaja majhno število bolnikov, mlajših od 18 let, ki potrebujejo velike odmerke antraciklinov, zaradi česar je tveganje za škodljive učinke na srce pri njih večje, se je odbor strinjal, da se kontraindikacija za to skupino odpravi.