FrancophonIA/ELRC3.0 huggingface dataset:
English: The product has a long duration of action; however, the exact clinical effect duration after a single injection is unknown.
Slovenian: Zdravilo ima dolgotrajno delovanje, vendar pa točno trajanje kliničnega delovanja po enkratnem odmerku ni znano.
English: Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Slovenian: Uporabite le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Slovenian: Ker ni študij kompatibilnosti, tega zdravila za uporabo v veterinarski medicini ne smete mešati z drugimi zdravili za uporabo v veterinarski medicini.
English: Following metaphylactic use, approximately 86% of the healthy animals remained free of clinical signs of disease (as compared to approximately 65% of animals in the untreated control group).
Slovenian: Po metafilaktični uporabi je približno 86 % zdravih živali ostalo brez kliničnih znakov bolezni (v primerjavi s približno 65 % živali v nezdravljeni kontrolni skupini).
English: Three amine substituents at the macrocyclic lactone ring result in a tri-basic character of the molecule.
Slovenian: Zaradi treh substituentov amina na makrocikličnem laktonskem obroču ima molekula tri-bazični značaj.
English: In line with responsible use principles, metaphylactic use of Zuprevo is only indicated in severe outbreaks of SRD caused by the indicated pathogens.
Slovenian: V skladu z načeli za odgovorno uporabo je metafilaktična uporaba zdravila Zuprevo indicirana samo v hudih izbruhih prašičje respiratorne bolezni, ki jo povzročijo indicirani patogeni.
English: 180 mg. For the full list of excipients, see section 6.1.
Slovenian: 180 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: The mean terminal half-life is approximately 9 days.
Slovenian: Povprečna končna razpolovna doba je 9 dni.
English: Special attention should be paid to using the appropriate injection site and to use the appropriate needle size and length (adjusted to the size and weight of animal) according to Good Veterinary Practice.
Slovenian: Posebno je treba paziti, da izberete primerno mesto za injiciranje in da uporabite primerno velikost in dolžino igle (glede na velikost in težo živali) v skladu z dobro veterinarsko prakso.
English: However, there was no evidence for any selective developmental or reproductive effects in any of the laboratory studies.
Slovenian: Z laboratorijskimi študijami niso bili dokazani selektivni razvojni ali reproduktivni učinki.
English: 4.7 Use during pregnancy and lactation or lay
Slovenian: 4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti
English: Tildipirosin
Slovenian: Tildipirozin
English: Minimum inhibitory concentration (MIC) data for the target pathogens (wild type distribution) are presented in the table below.
Slovenian: Podatki o minimalni inhibitorni koncentraciji (MIK) za ciljne patogene (distribucija divjega tipa) so prikazani na spodnji preglednici.
English: Carton Box
Slovenian: Kartonska škatla
English: 5831 AN Boxmeer The NETHERLANDS
Slovenian: 5831 AN Boxmeer NIZOZEMSKA
English: Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Slovenian: Ne uporabite pri brejih živalih, katerih mleko je namenjeno prehrani ljudi, v obdobju 2 mesecev pred pričakovano telitvijo.
English: The recommended injection site is the location just behind the ear at the highest point of the base of the ear, at the transition from bald to hairy skin.
Slovenian: Priporočeno mesto injiciranja je mesto za ušesom na najvišji točki korena ušesa, na prehodu z gole na dlakasto kožo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 6 May 2011.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobritve dovoljenja: 6. maj 2011
English: The rubber stopper of the vial may be safely punctured up to 20 times.
Slovenian: Gumijasti zamašek viale lahko varno prebodete do 20-krat.
English: Generally, cross-resistance between tildipirosin and other macrolides, lincosamides or streptogramins is to be expected.
Slovenian: Na splošno se pričakuje navzkrižna rezistenca med tildipirozinom in drugimi makrolidi, linkozamidi ali streptogramini.
English: The active substance in Zuprevo is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Zdravilna učinkovina v zdravilu Zuprevo je dovoljena učinkovina, kot je navedeno v tabeli 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
English: In very rare cases, anaphylactic reactions, with a potentially fatal outcome, might occur.
Slovenian: V zelo redkih primerih se lahko pojavi anafilaktična reakcija z možnim poginom.
English: In very rare cases, transient lethargy in piglets has been observed.
Slovenian: V zelo redkih primerih so pri pujskih opazili prehodno letargijo.
English: It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection.
Slovenian: Priporočljivo je zdraviti živali v zgodnjih fazah bolezni in ovrednotiti reagiranje na zdravljenje v 48 urah po injekciji.
English: In target animal safety studies, administration of the maximum recommended injection volume (5 ml) very commonly caused slight swellings at the injection site that were not painful on palpation.
Slovenian: V varnostnih študijah na ciljnih živalskih vrstah je dajanje maksimalnega priporočenega odmerka (5 ml) zelo pogosto na mestu injiciranja povzročilo rahle otekline, ki niso bile boleče na otip.
English: The mean total excretion of the total dose administered within 14 days was about 17% in urine and 57% in faeces.
Slovenian: Srednje celokupno izločanje celotnega odmerka, danega v 14 dneh, je bilo okrog 17 % z urinom in 57 % s fecesom.
English: Not for use in animals from which milk is produced for human consumption.
Slovenian: Ni za uporabo pri živalih, katerih mleko se uporablja za prehrano ljudi.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Slovenian: Rok uporabnosti zdravila za uporabo v pakiranju za prodajo: 2 leti
English: Do not use after the expiry date which is stated on the vial after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na viali za EXP.
English: It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 2 to 3 days after injection.
Slovenian: Priporočljivo je zdraviti živali v zgodnjih stopnjah bolezni in ovrednotiti reagiranje na zdravljenje v 2 do 3 dneh po injekciji.
English: If accidental eye exposure occurs, flush eyes immediately with clean water.
Slovenian: Če pride zdravilo v stik z očmi, oči takoj sperite s čisto vodo.
English: In vitro binding of tildipirosin to porcine plasma proteins is limited with approximately 30 %.
Slovenian: In vitro vezava tildipirozina na beljakovine v prašičji plazmi je omejena na približno 30 %.
English: The mean total excretion of the total dose administered within 14 days was about 24% in urine and 40% in faeces.
Slovenian: Srednje celokupno izločanje celotnega odmerka, danega v 14 dneh, je bilo okrog 24 % z urinom in 40 % s fecesom.
English: Tildipirosin is a 16-membered semi-synthetic macrolide antimicrobial agent.
Slovenian: Tildipirozin je 16-členski polsintitetični makrolid z antimikrobnim delovanjem.
English: There is cross resistance with other macrolides.
Slovenian: Obstaja navzkrižna odpornost z drugimi makrolidi.
English: Marketing authorisation holder: Intervet International B. V.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Intervet International B. V.
English: MANUFACTURER'S BATCH NUMBER Batch:
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE Serija:
English: Range (µg/ml) MIC50 (µg/ml) MIC90 (µg/ml)
Slovenian: Razpon(µg/ml) MIK50 (µg/ml) MIK90 (µg/ml)
English: Administer strictly intramuscularly.
Slovenian: Dajajte strogo intramuskularno.
English: Subcutaneous use.
Slovenian: Subkutana uporaba
English: Tildipirosin may cause sensitisation by skin contact.
Slovenian: Tildipirozin pri stiku s kožo lahko povzroči sensibilizacijo.
English: Another animal developed treatment related shock after the first administration and was euthanised on welfare grounds.
Slovenian: Pri drugi živali se je po prvi injekciji pokazal z zdravljenjem povezan šok in so jo evtanazirali zaradi dobrobiti živali.
English: Following the maximum recommended injection site volume of 5 ml, injection site reactions resolved completely within 21 days.
Slovenian: Po dajanju maksimalnega priporočenega odmerka 5 ml so reakcije na mestu injiciranja popolnoma izginile v 21 dneh.
English: Intervet International GmbH Feldstrasse 1 a 85716 Unterschleissheim GERMANY
Slovenian: Feldstrasse 1 a 85716 Unterschleissheim NEMČIJA
English: If clinical signs of respiratory disease persist or increase, treatment should be changed using another antibiotic, and continued until clinical signs have resolved.
Slovenian: Če se klinični znaki respiratorne bolezni še nadaljujejo ali povečajo, je treba zdravljenje spremeniti in uporabiti drug antibiotik in zdravljenje nadaljevati, dokler klinični znaki ne izginejo.
English: Do not use in case of hypersensitivity to macrolide antibiotics or to any of the excipients.
Slovenian: Ne uporabite v primeru preobčutljivosti za makrolidne antibiotike ali za katero koli pomožno snov.
English: Pain on injection and injection site swellings are very common in treated animals.
Slovenian: Bolečina ob injiciranju in otekline na mestu injiciranja so pri zdravljenih živalih zelo pogoste.
English: Special caution should be taken to avoid accidental self-injection, as toxicology studies in laboratory animals showed cardiovascular effects after intramuscular administration of tildipirosin.
Slovenian: Posebno je treba paziti, da ne pride do nenamernega samoinjiciranja, saj so toksikološke študije na laboratorijskih živalih pokazale kardiovaskularne učinke po intramuskularnem dajanju tildipirozina.
English: For E. coli, Campylobacter and Enterococci, both wild type and non-wild type phenotypes were observed (MIC range 1-> 64 µg/ml).
Slovenian: Za E. coli, Campylobacter in Enterococci,so bili ugotovljeni divji in nedivji fenotipi (razpon MIK 1.>64 µg/ml).
English: Following the maximum recommended injection site volume of 10 ml, injection site swellings may be associated with pain on palpation for about one day in individual animals.
Slovenian: Po injiciranju maksimalnega priporočenega odmerka 10 ml je oteklina na mestu injiciranja pri posameznih živalih kakšen dan lahko povezana z bolečino na otip.
English: Do not use in case of hypersensitivity to macrolide antibiotics, citric acid monohydrate or propylene glycol.
Slovenian: Ne uporabite zdravila v primeru preobčutljivosti za makrolidne antibiotike, citronsko kislinomonohidrat ali propilen glikol.
English: EXPIRY DATE EXP:
Slovenian: EXP:
English: If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed using another antibiotic, and continued until clinical signs have resolved.
Slovenian: Če se klinični znaki respiratorne bolezni še nadaljujejo ali povečajo, ali če se bolezen ponovi, je treba zdravljenje spremeniti in uporabiti drug antibiotik in zdravljenje nadaljevati, dokler klinični znaki ne izginejo.
English: The presence of the disease in the herd should be confirmed before preventive treatment.
Slovenian: Pred preventivnim zdravljenjem je treba potrditi prisotnost bolezni v čredi.
English: Once opened, use within 28 days.
Slovenian: Načeto zdravilo uporabite v 28 dneh.
English: B. bronchiseptica
Slovenian: P. multocida B. bronchiseptica
English: Needle length (cm)
Slovenian: Dolžina igle (cm)
English: Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/45 kg body weight) once only.
Slovenian: Dajte 4 mg tildipirozina/kg telesne teže (kar ustreza 1ml/45 kg telesne teže) samo enkrat.
English: Vial (100 ml, 250 ml)
Slovenian: Viala (100 ml, 250 ml)
English: Box
Slovenian: Škatla
English: Resistance to macrolides generally results from three mechanisms: (1) the alteration of the ribosomal target site (methylation), often referred to as MLSB resistance as it affects macrolides, lincosamides and group B streptogramins; (2) the utilisation of active efflux mechanism; (3) the production of inactivating enzymes.
Slovenian: Rezistenca na makrolide je na splošno posledica treh mehanizmov: (1) spremembe ribosomskega ciljnega mesta (metilacija), ki jo pogosto označujejo kot rezistenco na MLSB, ker deluje na makrolide, linkozamide in na skupino B streptograminov, (2) izkoriščanja aktivnega mehanizma iztekanja; (3) proizvodnje inaktivirajočih encimov.
English: In vitro binding of tildipirosin to bovine plasma and bronchial fluid proteins is limited with approximately 30%.
Slovenian: In vitro vezava tildipirozina na beljakovine v goveji plazmi in bronhialni tekočini je omejena na približno 30 %.
English: The efficacy of metaphylactic use of Zuprevo was demonstrated in a placebo controlled multi-centre field study, when outbreak of clinical disease was confirmed (i.e. animals in at least 30% of the pens sharing the same airspace showed clinical signs of SRD, including at least 10% animals per pen within 1 day; or 20% within 2 days or 30% within 3 days).
Slovenian: Učinkovitost metafilaktične uporabe zdravila Zuprevo je bile dokazana v multicenrični s placebom kontrolirani terenski študiji, ko je bil potrjen izbruh klinične bolezni (tj., najmanj 30 % živali v enem boksu v istem prostoru je imelo klinične znake SRD, vključujoč najmanj 10 % živali v 1 dnevu ali 20 % živali v 2 dnevih ali 30 % živali v 3 dnevih).
English: If accidental skin exposure occurs, wash the skin immediately with soap and water.
Slovenian: V primeru nenamernega razlitja po koži kožo takoj operite z milom in vodo.
English: The swellings are transient and will usually resolve within 7 to 16 days; in individual animals swellings may persist for 21 days.
Slovenian: Otekline so prehodne in navadno splahnijo v 7 do 16 dneh.
English: During clinical trials, pain on injection and injection site swellings were seen very commonly in treated pigs.
Slovenian: Med kliničnimi poskusi so bolečino ob injiciranju in otekline na mestu injiciranja na zdravljenih prašičih opazili zelo pogosto.
English: Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/10 kg body weight) once only.
Slovenian: Dajte 4 mg tildipirozina/kg telesne teže (kar ustreza 1ml/10 kg telesne teže) samo enkrat.
English: Metaphylaxis implies that clinically healthy animals in close contact with diseased animals are administered the product at the same time as the treatment of the clinically diseased animals, to reduce the risk for development of clinical signs.
Slovenian: Pri metafilaksi je potrebno, da klinično zdrave živali, ki so v tesnem stiku z obolelimi živalmi, dobijo zdravilo istočasno kot obolele živali, da se zmanjša tveganje razvoja kliničnih znakov.
English: Intramuscular use.
Slovenian: Intramuskularna uporaba
English: Metaphylaxis implies that clinically healthy animals in close contact with diseased animals are administered the veterinary medicinal product at the same time as the treatment of the clinically diseased animals, to reduce the risk for development of clinical signs.
Slovenian: Pri metafilaksi je potrebno, da klinično zdrave živali, ki so v tesnem stiku z obolelimi živalmi, dobijo zdravilo za uporabo v veterinarski medicini istočasno kot obolele živali, da se zmanjša tveganje razvoja kliničnih znakov.
English: In cattle, it is postulated that metabolism of tildipirosin proceeds by cleavage of the mycaminose sugar moiety, by reduction and sulphate conjugation with subsequent hydration (or ring opening), by demethylation, by mono- or dihydroxylation with subsequent dehydration and by S-cysteine and Sglutathione conjugation.
Slovenian: Pri govedu se predpostavlja, da metabolizem tildipirozina poteka z odcepitvijo micaminose dela sladkorja, z zmanjševanjem in konjugacijo sulfata z naknadno hidraciji (ali odprtjem obroča), z demetilacijo, z mono- ali dihidroksilacijo s posledično dehidracijo in s konjugacijo S-cisteina in Sglutationa.
English: Pathomorphological injection site reactions resolved completely within 21 days.
Slovenian: Patomorfološke reakcije na mestu injiciranja so popolnoma izginile v 21 dneh.
English: In pigs, it is postulated that the metabolism of tildipirosin proceeds by reduction and sulphate conjugation with subsequent hydration (or ring opening), by demethylation, by dihydroxylation and by S-cysteine and S-glutathione conjugation.
Slovenian: Pri prašičih se predpostavlja, da metabolizem tildipirozina poteka z redukcijo in konjugacijo sulfata z naknadno hidracijo (ali odprtjem obroča), z demetilacijo, s hidroksilacijo in s konjugacijo S-cisteina in S-glutationa.
English: To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Slovenian: Da bi zagotovili pravilno odmerjanje, je treba čim natančneje določiti telesno težo, da ne bi bil odmerek premajhen.
English: 40 mg. For the full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Resistance to macrolides generally results from three mechanisms: (1) the alteration of the ribosomal target site (methylation), often referred to as MLSB resistance as it affects macrolides, lincosamides and group B streptogramins, (2) the utilisation of active efflux mechanism; (3) the production of inactivating enzymes.
Slovenian: Rezistenca na makrolide je na splošno posledica treh mehanizmov: (1) spremembe ribosomskega ciljnega mesta (metilacija), ki jo pogosto označujejo kot rezistenco na MLSB, ker deluje na makrolide, linkozamide in na skupino B streptograminov, (2) izkoriščanje aktivnega mehanizma iztekanja; (3)
English: To ensure correct dose, body weight should be determined as accurately as possible to avoid underdosing.
Slovenian: Da bi zagotovili pravilen odmerek, je treba čim natančneje določiti telesno težo, da ne bi bil odmerek premajhen.
English: METHOD AND ROUTE OF ADMINISTRATION Subcutaneous injection
Slovenian: NAČIN IN POT(I) UPORABE Subkutana injekcija
English: Therefore, the product should not be administered with antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Slovenian: Zato zdravila ne dajajte skupaj z antimikrobnimi zdravili s podobnim načinom delovanja, kot so drugi makrolidi ali linkozamidi.
English: Injection site reactions will largely resolve within 35 days.
Slovenian: Reakcije na mestu injiciranja v glavnem izginejo v 35 dneh.
English: In vitro, the effect of tildipirosin is bactericidal against M. haemolytica and H. somni, and bacteriostatic against P. multocida.
Slovenian: In vitro je delovanje tildipirozina bakteriocidno za M. haemolytica in H. somni, bakteriostatično pa za P. multocida.
English: Needle diameter (mm)
Slovenian: Premer igle (mm)
English: Tildipirosin Bovine 400 μg/kg
Slovenian: Tildipirozin Tildipirozin Govedo 400
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Slovenian: Varnost zdravila za uporabo v veterinarski medicini ni bila ugotovljena v obdobju brejosti in laktacije.
English: Tildipirosin administered subcutaneously to cattle at a single dose of 4 mg/kg body weight resulted in rapid absorption with average peak plasma concentration of 0.7 µg/ml within 23 minutes (Tmax) and high absolute bioavailability (78.9%).
Slovenian: Tildipirozin, ki so ga dajali subkutano govedom v enkratnem odmerku 4 mg/kg telesne teže, se je hitro absorbiral in dosegel največjo koncentracijo v plazmi 0.7 µg/ml v 23 minutah (Tmax) in visoko absolutno biorazpožljivost (78,9%).
English: Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, the bacterial pathogens most commonly associated with bovine respiratory disease (BRD).
Slovenian: Mannheimia haemolytica, Pasteurella multocida in Histophilus somni, bakterijske patogene, ki so najpogosteje povezani z respiratorno boleznijo goveda (BRD).
English: The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Slovenian: Varnost zdravila za uporabo v veterinarski medicini v obdobju brejosti ali laktacije ni bila ugotovljena.
English: Tildipirosin administered intramuscularly to pigs at a single dose of 4 mg/kg body weight was rapidly absorbed reaching average peak plasma concentration of 0.9 µg/ml within 23 minutes (Tmax).
Slovenian: Tildipirozin, ki so ga dajali prašičem intramuskularno v enkratnem odmerku 4 mg/kg telesne teže, se je hitro absorbiral in dosegel največjo koncentracijo v plazmi 0.9 µg/ml v 23 minutah (Tmax).
English: Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis, which are the bacterial pathogens most commonly associated with swine respiratory disease (SRD).
Slovenian: Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica in Haemophilus parasuis, ki so bakterijski patogeni, najpogosteje povezani s prašičjo respiratorno boleznijo (SRD).
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila
English: MARKETING AUTHORISATION NUMBERS EU/2/11/124/005-008
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/11/124/005-008
English: Overdoses of 10 times the recommended dose as well as repeated subcutaneous administration of the veterinary medicinal product only led to transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in calves.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) Preveliki odmerki 10-kratnega priporočenega odmerka kakor tudi ponovno subkutano dajanje zdravila za uporabo v veterinarski medicine je imelo za posledico le pri nekaterih živalih prehodne klinične znake neugodja in otekline na mestu injiciranja, povezane z bolečino pri teletih.
English: To be supplied only on veterinary prescription.
Slovenian: Samo za živali - na veterinarski recept
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) The veterinary medicinal product is a clear yellowish solution for injection containing 40 mg/ml of tildipirosin
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN Zdravilo za uporabo v veterinarski medicini je bistra rumenkasta raztopina za injiciranje, ki vsebuje 40 mg/ml tildipirozina.
English: Do not administer simultaneously with other macrolides or lincosamides (see section 4.8)
Slovenian: Ne dajajte istočasno z drugimi makrolidi ali linkozamidi (glejte poglavje 4.8)
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) ZUPREVO is a clear yellowish solution for injection containing 180 mg/ml of tildipirosin
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SESTAVIN ZUPREVO je bistra rumenkasta raztopina za injiciranje, ki vsebuje 180 mg/ml tildipirozina.
English: Cattle (meat and offal): 47 days.
Slovenian: Govedo (meso in organi): 47 dni
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: antibacterials for systemic use, macrolides.
Slovenian: FARMAKOLOŠKE LASTNOSTI Farmakoterapevtska skupina: : zdravila za sistemsko zdravljenje bakterijskih infekcij, makrolidni antiobiotiki
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Evropske agencije za zdravila (European Medicines Agency,http://www.ema.europa.eu/.