natgillin/translations-raw huggingface dataset:
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, nastale iz tega zdravila, je treba odstraniti v skladu z lokalnimi predpisi.
Recuvyra is a strong and long-lasting painkiller, and should only be used for major surgery that requires opiate analgesia for a duration of at least 4 days. 
Recuvyra je močno protibolečinsko sredstvo z dolgotrajnim delovanjem in se lahko uporablja samo za večje kirurške posege, ki zahtevajo opiatno analgezijo v trajanju najmanj 4 dni.
The use of syringes not supplied with this veterinary medicinal product, or storage of this veterinary medicinal product in a syringe may lead to dosing inaccuracy. 
Uporaba brizg, ki niso priložene temu zdravilu, ali shranjenjevanje tega zdravila v brizgi lahko privede do nenatančnih odmerkov.
Commonly (i.e. in 1 to 10% of treated dogs) 
Pogosto (tj. med 1 in 10 % zdravljenih psov)
Blot up any noticeable solution using an absorbent material such as paper tissues. 
Popivnajte vso vidno raztopino z absorpcijskim materialom kot npr. s papirnatimi brisačami.
To avoid anaesthetic overdose in dogs treated with the veterinary medicinal product, anaesthetic agents should be administered until the desired effect is produced. 
Za preprečevanje prevelikega odmerjanja anestetikov pri psih, ki so bili zdravljeni s tem zdravilom, je treba anestetike odmerjati, dokler ne dosežejo želenih učinkov.
• A 3 ml polypropylene syringe with a silicone O-ring fitted to the plunger. 
• 3- mililitrska polipropilenska brizga s silikonskim tesnilnim obročkom, nameščenim na bat
If symptoms develop following exposure to the veterinary medicinal product such as erythema, confusion, nausea or vomiting, medical advice should be sought immediately. 
Če se po izpostavitvi zdravilu pojavijo simptomi kot rdečina, zmedenost, slabost ali bruhanje, je treba takoj poiskati zdravniško pomoč.
The mean plasma fentanyl concentration from time 0 through 96 hours post-dose administration is approximately 1.32 ng/ml. 
Srednja koncentracija fentanila v plazmi v času od 0 do 96 ur po dajanju odmerka je približno 1,32 ng/ml.
Your veterinarian should use Recuvyra with caution in conjunction with other morphine or other opioid pain relievers, or α-adrenergic agonists because the possible side-effects have not been studied. 
Veterinar mora uporabljati Recuvyro previdno v kombinaciji z drugim morfinom ali drugimi opioidnimi protibolečinskimi sredstvi ali α-adrenergičnimi agonisti, ker možnih stranskih učinkov niso proučevali.
Withdrawing the solution from the vial (see Figure 2): 
Jemanje raztopine iz viale (glejte sliko 2):
Keep this package leaflet in a safe place. 
Hranite to navodilo za uporabo na varnem mestu.
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 
BESEDILO "SAMO ZA ŽIVALI” Samo za živali.
At a high dose, fentanyl is known to cause a potentially fatal respiratory depression. 
Znano je, da lahko fentanil v visokem odmerku eventualno povzroči smrtno depresijo dihanja.
Restrain the dog for approximately 2 minutes and avoid contact with the application site for 5 minutes to allow complete drying of the solution. 
Držite psa pri miru približno 2 minuti in se izogibajte stiku z mestom nanosa 5 minut, da omogočite
Dogs must not be discharged to owners until post-operative sedation is mild or absent and dogs are drinking water and eating voluntarily at an appropriate level for the condition that required surgery. 
Psi se ne smejo odpustiti k lastnikom, dokler ni postoperativna sedacija blaga ali je ni več in psi prostovoljno pijejo vodo in jedo v količinah, primerljivih s stanjem pred kirurško operacijo.
The use of the veterinary medicinal product may result in corneal drying during prolonged sedation. 
Uporaba zdravila lahko med podaljšano sedacijo povzroči sušenje roženice.
Fentanyl is extensively metabolised and excreted into the urine. 
Fentanil se obsežno presnavlja in izloča v urin.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Recuvyra is a clear, colourless to light yellow solution containing 50 mg of fentanyl (the active substance) per ml of solution. 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Recuvyra je bistra, brezbarvna do svetlo rumena raztopina, ki vsebuje 50 mg fentanila (zdravilne učinkovine) na ml raztopine.
Following application to the skin, fentanyl is rapidly absorbed into the skin. 
Po nanosu na kožo se fentanil hitro absorbira v kožo.
Do not administer to skin that does not have an intact stratum corneum due to injury or disease. 
Ne uporabite na koži, pri kateri je zaradi rane ali bolezni poškodovan stratum corneum.
Accumulation of fentanyl following repeated administration could result in severe adverse reactions, including death. 
Kopičenje fentanila po ponovnem dajanju ima lahko za posledico hude neželene učinke, tudi smrt.
Fentanyl is a potent anaesthetic sparing substance. 
Fentanil je močno nadomestno anestezijsko sredstvo.
In case of accidental spillage onto skin, immediately flush the area with water, then wash the area with copious amounts of soap and water and seek prompt medical advice, showing the physician this warning, the package leaflet or the label. 
Ob nenamernem razlitju po koži takoj sperite mesto z vodo, nato ga umijte z veliko količino mila in vode in se takoj posvetujte z zdravnikom ter mu pokažite navodilo za uporabo, ovojnino ali nalepko.
PHARMACEUTICAL FORM Transdermal solution. 
FARMACEVTSKA OBLIKA Transdermalna raztopina.
Following application to dogs, do not touch the site for 5 minutes. 
Po nanosu na psa se mesta nanosa ne dotikajte vsaj 5 minut.
Therefore, dogs should be continuously monitored for rectal temperature, pulse rate, respiratory rate and heart rhythm during surgical anaesthesia. 
Zato je treba psom med kirurško anestezijo neprekinjeno nadzirati rektalno temperaturo, pulz, hitrost dihanja in srčni ritem.
The use of the veterinary medicinal product is intended as a single application administered 2 to 4 hours prior to surgery to provide analgesia for at least 4 days. 
Namen uporabe zdravila je z enim dajanjem 2 do 4 ure pred kirurško operacijo zagotoviti analgezijo v trajanju najmanj 4 dni.
Do not give more than the recommended dose of the veterinary medicinal product. 
Ne dajajte več kot priporočenega odmerka zdravila.
When the vial is broached for the first time, the date on which any product remaining in the vial should be discarded should be written in the space provided on the label, using the in-use shelf-life. 
Ko je viala prvič odprta, je treba v prostor na nalepki zapisati datum, ob katerem je treba zavreči preostanek zdravila v viali, pri čemer se upošteva rok uporabnosti od prve uporabe.
Only up to 0.5 ml can be applied to one area of skin. 
Na eno mesto na koži se lahko nanese največ do 0,5 ml.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Fentanyl 50 mg/ml 
NAVEDBA ZDRAVILNE UČINKOVIN IN DRUGIH SNOVI Fentanil 50 mg/ml
Personal protective equipment consisting of latex or nitrile gloves, eye protection and suitable protective clothing should be worn when handling this veterinary medicinal product. 
Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz lateksnih ali nitrilnih rokavic, zaščite za oči in ustrezne zaščitne obleke.
Application of Recuvyra will not cause your dog any pain and your veterinarian will use a dosing table and a specially designed applicator to carefully apply the product onto the skin surface without using any needles. 
Nanos Recuvyre psu ne bo povzročil bolečin in veterinar bo uporabil tabelo odmerkov ter posebej zasnovan aplikator, s katerim bo skrbno nanesel zdravilo na površino kože brez uporabe igel.
Plasma fentanyl concentrations reach 1.0 ng/ml, (which is generally considered analgesic) in more than 60% of dogs within 4 hours of administration. 
Pri več kot 60 % psov dosežejo koncentracije fentanila v plazmi 1,0 ng/ml (kar se na splošno šteje kot analgetsko) v prvih 4 urah po dajanju.
The maximum plasma fentanyl concentrations of 0.7 to 4.7 ng/ml are reached within 10 to 18 hours of dose administration. 
Maksimalne koncentracije fentanila 0,7 do 4,7 ng/ml v plazmi se dosežejo med 10 do 18 urami po dajanju odmerka.
However, in dogs with thick hair coats, it is advisable to clip the hair prior to application to assure direct contact of the veterinary medicinal product with the skin. 
Pri psih z gosto dlako pa jo je priporočljivo pred nanosom dlako ostriči, da se zagotovineposreden stik zdravila s kožo.
Recuvyra is a solution designed to be carefully applied to your dog's skin only by a veterinarian. 
Recuvyra je raztopina, zasnovana za pazljivo dajanje na pasjo kožo, ki ga opravi samo veterinar.
Do not give a second dose of the veterinary medicinal product within 7 days. 
Drugega odmerka zdravila ne dajajte vsaj 7 dni.
Fentanyl is highly lipid soluble and distributes rapidly into a variety of tissues readily crossing the blood-brain barrier in the dog. 
Fentanil je zelo topen v lipidih in se hitro porazdeli v različna tkiva, pri čemer pri psu hitro prestopi krvno-možgansko pregrado.
To accurately withdraw the correct amount, align the top of the O-ring on the syringe plunger with the appropriate tick mark on the syringe barrel. 
Za točen odvzem pravilne količine poravnajte vrh tesnilnega obročka na batu brizge z ustrezno črtico skale na valju brizge.
Dispose of the used syringe/applicator tip as a unit in an appropriate container. 
Odlagajte uporabljeno brizgo/aplikacijski nastavek v enem kosu v ustrezno zbirno posodo.
Do not administer to areas other than the dorsal scapular region. 
Ne uporabite na drugih območjih, kot je hrbtno skapularno.
Type I amber glass vial containing 10 ml solution, closed with a grey butyl rubber stopper sealed with a two piece aluminium seal with a grey flip-off plastic disc. 
Viala iz rjavega stekla tipa I z 10 ml raztopine, s sivim zamaškom iz butilnega kavčuka, z dvodelno aluminijasto zaporko sivo plastično odmično ploščico.
Isopropyl alcohol 
Oktilsalicilat Izopropilalkohol
SPECIAL WARNING(S), IF NECESSARY Accidental administration is dangerous - see Summary of Product Characteristics before use 
POSEBNO OPOZORILO, ČE JE POTREBNO Nenamerno dajanje je nevarno - pred uporabo preberite Povzet ek glavni h značilnosti zdravila.
In the event that any of the following observations are made following the application/overdose of the veterinary medicinal product, reversal should be initiated: severe sedation, unconsciousness, seizures, laboured or abdominal breathing or severe hypotension. 
Začnite z reverzijo, če po nanosu/prevelikem odmerjanju tega zdravila opazite naslednje pojave: močno sedacijo, nezavest, krče, težavno ali abdominalno dihanje ali močno hipotenzijo.
For the control of post-operative pain associated with major orthopaedic and soft tissue surgery in dogs. 
Za lajšanje postoperativnih bolečin pri večjih kirurških ortopedskih operacijah in operacijah mehkih tkiv pri psih.
• A 2-pronged polycarbonate applicator tip. 
• 2-krak polikarbonaten aplikacijski nastavek
The vial must be placed upright on a firm, stable surface during placement and application of the adaptor. 
Vialo je treba med nameščanjem in uporabo adapterja postaviti navpično na trdno stabilno površino.
Do not re-use syringes. 
Ne uporabljajte jih ponovno.
In case of accidental eye contact with the veterinary medicinal product, rinse with abundant quantities of water and seek medical advice immediately. 
Ob nenamernem stiku z očmi z zdravilom spirajte oči z obilo vode in takoj poiščite zdravniško pomoč.
Place applicator tip at an approximate 45º angle directly onto the skin in the dorsal scapular region. 
Postavite aplikacijski nastavek neposredno na kožo na hrbtnem skapularnem območju pod kotom 45°.
Turn the vial into the upright position, grasp the adaptor, turn the syringe ¼ turn anti-clockwise and remove the syringe. 
Obrnite vialo v pokončen položaj, primite adapter, zavrtite brizgo za ¼ v nasprotni smeri gibanja urinih kazalcev in jo odstranite.
Dose (ml) 
Odmerek (ml)
The application site should be clean and free of any surface matter. 
Mesto nanosa mora biti čisto in brez tujkov na površini.
Laboratory studies conducted in rats have not shown any evidence of teratogenic effect, or any adverse effect on fertility or embryo-foetal development. 
Plodnost: Laboratorijske študije na podganah niso dokazale teratogenih učinkov ali drugih neželenih učinkov na
Dogs weighing 20 kg or more will be kept at the veterinary clinic for at least 48 hours after treatment with Recuvyra. 
Psi s težo 20 kg ali več bodo ostali na veterinarski kliniki najmanj 48 ur po zdravljenju z Recuvyro.
Dogs that are moderately sedated and not drinking water and eating voluntarily should be evaluated for dehydration and administered supplemental fluid and nutrition support as necessary. 
Pri psih, ki so v stanju zmerne sedacije in ne pijejo vode in ne jedo prostovoljno, je treba oceniti dehidracijo in po potrebi dajati dodatno tekočinsko in prehransko podporo.
If your dog is more than mildly sedated, or has decreased appetite or water intake, you should contact your veterinary surgeon for advice. 
Če je pes v stanju, slabšem od blage sedacije, ali ima zmanjšan tek ali pije manj vode, se posvetujte z vašim veterinarjem.
Once applied to the skin, the veterinary medicinal product rapidly dries resulting in percutaneous absorption of fentanyl. 
Po nanosu na kožo se veterinarsko zdravilo hitro suši zaradi absorpcije fentanila skozi kožo.
Dogs that are moderately sedated, and are not drinking water and eating voluntarily at an appropriate level for the condition that required surgery, should be evaluated for dehydration and administered supplemental fluid and nutrition support as necessary. 
Psom, ki so v stanju zmerne sedacije in ne pijejo vode in ne jedo prostovoljno v količinah, primerljivih s stanjem pred kirurško operacijo, je treba oceniti dehidracijo in po potrebi dajati dodatno tekočinsko in prehransko podporo.
• Is lactating, pregnant or a dog used for breeding. 
• Je v obdobju laktacije ali brejosti ali če se uporablja kot vzrejna žival.
If needed, your veterinarian might administer more than one dose of naloxone to your dog. 
Po potrebi lahko veterinar da psu več kot en odmerek naloksona.
The veterinary medicinal product should be administered with caution. 
Pri dajanju zdravila je potrebna previdnost.
Do not use the veterinary medicinal product in lactating or pregnant bitches or breeding animals. 
Ne uporabite zdravila za psice med laktacijo ali brejostjo ali za vzrejne živali.
Do not give a second dose of the veterinary medicinal product. 
Ne dajajte drugega odmerka zdravila.
In rare cases, dysphoria and urinary retention have also been observed. 
V redkih primerih se lahko pojavita disforija in zadrževanje urina.
If the volume to be administered is greater than 0.5 ml, move the applicator tip at least 2.5 cm from the initial site and apply up to 0.5 ml. 
Če je volumen, ki ga je treba dati, večji od 0,5 ml, premaknite aplikacijski nastavek najmanj 2,5 cm vstran od začetnega mesta in nanesite do 0,5 ml. Ponavljajte, dokler pes ni prejel vsega izračunanega volumna.
If needed, re-administer naloxone. 
Po potrebi ponovno dajajte nalokson.
If a child orally contacts the application site within 72 hours of application, medical attention should be sought immediately. 
Če se otrok dotakne mesta nanosa z usti do 72 uro po nanosu,je treba takoj poiskati zdravniško pomoč.
• very rare (less than 1 animal in 10,000 animals, including isolated reports). 
• zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
Priestley Road Basingstoke, Hampshire RG24 9NL United Kingdom 
Hampshire RG24 9NL UK
To withdraw the solution from the vial, press the provided syringe tip into the centre of the adaptor and gently turn the syringe approximately ¼ turn clockwise until fully seated. 
Za jemanje raztopine iz viale pritisnite konico priložene brizge v sredino adapterja in rahlo zavrtite brizgo v smeri gibanja urinih kazalcev za ¼, dokler trdno ne sede.
Attach the applicator tip to the syringe by turning the applicator tip 1/3 turn clockwise 2. 
Pritrdite aplikacijski nastavek na brizgo tako, da ga zavrtiteza 1/3 obrata v smeri gibanja urinih kazalcev.
Site preparation: It is not necessary to clip the hair over the application site. 
Priprava mesta nanosa: Nad mestom nanosa ni treba striči dlake.
Dosing device: 
Dozirna naprava:
The analgesic effects of the veterinary medicinal product are related to the resulting fentanyl blood concentration achieved following application. 
Analgetski učinki tega zdravila so odvisni od koncentracije fentanila v krvi po dajanju.
Store the vial together with the Summary of Product Characteristics (SPC). 
Shranjujte vialo skupaj s Povzetkom glavnih značilnosti zdravila.
If your dog weighs more than 20 kg, then it will remain in hospital for at least 48 hours following application of Recuvyra. 
Če vaš pes tehta več kot 20 kg, potem bo ostal v bolnišnici najmanj 48 ur po nanosu Recuvyre.
It may be necessary to evacuate air from the syringe back into the vial. 
Po potrebi potisnite zrak iz brizge nazaj v vialo.
Unless your dog has thick hair it will not usually be necessary to clip/ shave your dog's hair between the shoulder blades for correct application. 
Za pravieln nanos običajno ni potrebno striženje/britje dlake med lopaticama psa, razen če je dlaka gosta.
The product should only be applied by a veterinarian. 
Zdravilo naj nanese samo veterinar.
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
NAME OF THE VETERINARY MEDICINAL PRODUCT Recuvyra 50 mg/ml transdermal solution for dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Recuvyra 50 mg/ml, transdermalna raztopina za pse
INDICATION(S) Recuvyra controls pain in dogs that have undergone major orthopaedic or soft tissue surgery. 
Recuvyra lajša bolečine pri psih, ki prestajajo večje kirurške ortopedske operacije in operacije mehkih tkiv.
Therefore, treated dogs of more than 20 kg body weight have to be kept at the hospital for 48 hours post-application. 
Zato je treba zdravljene pse s telesno težo nad 20 kg zadržati v bolnišnici 48 ur po nanosu.
In case of accidental ingestion of the veterinary medicinal product, seek medical advice immediately. 
Ob nenamernem zaužitju zdravila takoj poiščite zdravniško pomoč.
Withdrawing the solution from the vial Attaching the applicator tip (see Figure 3): 
Pritrjevanje aplikacijskega nastavka (glejte sliko 3):
• Has heart failure, low or high blood pressure, low blood volume, impaired breathing, has a history of epilepsy, non-aged related corneal pathology or has or might have a partial or completely stationary bowel. 
• Ima srčno napako, nizek ali visok krvni tlak, nizek volumen krvi, prizadeto dihanje, ima
(hrs) 
(ure)
PACKAGE LEAFLET Recuvyra 50 mg/ml transdermal solution for dogs 
NAVODILO ZA UPORABO Recuvyra 50 mg/ml, transdermalna raztopina za pse
Attaching the Applicator Tip 
Pritrjevanje aplikacijskega nastavka
SPECIAL STORAGE CONDITIONS Store the broached vial with the adaptor in an upright position. 
POSEBNA NAVODILA ZA SHRANJEVANJE Prebodeno vialo z adapterjem shranjujte v pokončnem položaju.
• common (more than 1 but less than 10 animals in 100 animals) 
• pogosti (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 100 živali)
Fertility: 
Viala:
The tissues should be discarded immediately following use. 
Takoj po uporabi brisače odstranite.
Manufacturer for batch release: 
Izdelovalec, odgovoren za sproščanje serij:
Applying gentle, even pressure, press the adaptor onto the vial until it is seated. 
Narahlo, z enekomernim pritiskom, potisnite adapter na vialo, da nasede nanjo.
• very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) 
• zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali med enim zdravljenjem)
Recuvyra should only be used for major surgery that requires opiate analgesia for a duration of at least 4 days. 
Posebna opozorila Recuvyra se lahko uporablja samo za večje kirurške operacije, ki zahtevajo trajanje opiatne analgezije
EXPIRY DATE EXP:MM/YYYY Once broached, use by…. 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: MM/LLLL
• rare (more than 1 but less than 10 animals in 10,000 animals) 
• redki (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 10.000 živali)
Should subsequent surgery be intended in a dog previously treated with the veterinary medicinal product, a minimum of a 7 day dosing interval must be observed before administering another dose. 
Če je treba pri psu, ki mu je bilo že dano zdravilo, izvesti naslednjo kirurško operacijo, morate pred dajanjem naslednjega odmerka narediti najmanj 7-dnevni presledek.
• uncommon (more than 1 but less than 10 animals in 1,000 animals) 
• občasni (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 1.000 živali)
Invert vial and pull back on the syringe plunger until the appropriate volume is withdrawn. 
Obrnite vialo na glavo in povlecite bat brizge navzdol, da zajamete potrebni volumen.
Dogs of more than 20 kg bodyweight should remain in the hospital for a minimum of 48 hours following application. 
Psi s telesno težo, večjo od 20 kg, morajo ostati v bolnišnici najmanj 48 ur po dajanju.
Store the broached vial with the adaptor in an upright position. 
Prebodeno vialo z adapterjem shranite v pokončnem položaju.
10 DATE OF REVISION OF THE TEXT {MM/YYYY} 
DATUM REVIZIJE BESEDILA
6.5 Nature and composition of immediate packaging Vial: 
6.5 Vrsta ovojnine in vsebina
Do not re-use syringes or applicator tips. 
Brizge ali aplikacijski nastavki niso za ponovno uporabo.
D. STATEMENT OF THE MRLs Not applicable. 
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
QUANTITY OF THE ACTIVE SUBSTANCE(S) Fentanyl 50 mg/ml 
K O LIČINA ZDRA VILN E UČINKO VINE Fentanil 50 mg/l
Polska (Poland) 
Hrvatska (Croatia)
Terminal half-life (hrs) 
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVI (MRL)
fax: +40-21-4023001 Romania 
Tel. : +33/(0)1 55 49 35 29 France
London, 03 April 2006 EMEA/CHMP/106563/2006 
London, 3. aprila 2006 EMEA/CHMP/106563/2006
A positive opinion was adopted 26 January 2006. 
Pozitivno mnenje je bilo sprejeto 26. januarja 2006.
The Reference Member State was Netherlands and the Concerned Member States were Belgium and the United Kingdom. 
Referenčna država članica je bila Nizozemska, zadevni državi članici pa Belgija in Združeno kraljestvo.
The differences in section 4.3 and 4.6 were considered to be of serious public health concern. 
Ocenjeno je bilo, da razlike v poglavjih 4.3 in 4.6 razlog vzbujajo resne pomisleke v zvezi z javnim zdravjem.
The Rapporteur and Co-Rapporteur appointed were Tomas Salmonson and Eric Abadie, respectively. 
Poročevalec oz. soporočevalec sta bila Tomas Salmonson oz. Eric Abadie.
The final opinion was converted into a Decision by the European Commission on 03 April 2006. 
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 3. aprila 2006.
These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. 
Te države članice niso uspele doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, podeljenega s strani referenčne države članice.
The United Kingdom referred the reasons for disagreement to the EMEA on 23 August 2005. 
Združeno kraljestvo je agenciji EMEA posredovalo razloge za nesoglasje dne 23. avgusta 2005.
The Mutual Recognition Procedure started on 25 May 2005. 
Postopek medsebojnega priznavanja se je pričel 25. maja 2005.
The arbitration procedure started on 15 September 2005. 
Postopek arbitraže se je pričel 15. septembra 2005.
Section 4.3 and 4.6 of the SPC of the reference product in the UK contains the information that the product is contraindicated in pregnancy, for women capable of childbearing or for nursing mothers. 
Poglavji 4.3 in 4.6 SPC referenčnega izdelka v Združenem kraljestvu vsebujeta informacijo, da je izdelek kontraindiciran v nosečnosti, za ženske v rodni dobi ali za doječe matere.