FrancophonIA/ELRC3.0 huggingface dataset:
English: In rare occasions swelling can reach a diameter up to 15-20 cm, with duration up to 2-3 weeks, that may require symptomatic treatment.
Slovenian: V redkih primerih se lahko pojavi oteklina s premerom do 15-20 cm, ki traja do 2-3 tedne in lahko zahteva simptomatsko zdravljenje.
English: The excipients, including adjuvants, 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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Slovenian: SPC tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
English: Name and address of the manufacturers of the biological active substances
Slovenian: Ime in naslov proizvajalcev biološko aktivnih učinkovine
English: The vaccine stimulates active immunity against equine influenza.
Slovenian: Cepivo spodbuja aktivno imunost proti konjski influenci.
English: A transient swelling which usually regresses within 4 days may appear at the injection site.
Slovenian: Na mestu injiciranja se lahko pojavi prehodna oteklina, ki običajno izgine v 4 dneh.
English: Carbomer ........................................................................................................................................... 4 mg.
Slovenian: Karbomer .............................................................................................................................................. 4 mg
English: Pain, local hyperthermia and muscle stiffness can occur in rare cases.
Slovenian: V redkih primerih se lahko pojavijo bolečina, lokalno povišana temperatura in otrdelost mišic.
English: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous Water for injections
Slovenian: Natrijev dihidrogenfosfat dihidrat Kalijev dihidrogenfosfat, brezvodni Voda za injekcije
English: In very rare occasions, abscessation may be observed.
Slovenian: V zelo redkih primerih se lahko pojavi absediranje.
English: Duration of immunity induced by the vaccination scheme: 5 months after primary vaccination course and 1 year after the third vaccination.
Slovenian: Čas trajanja imunosti, ki ga spodbudi predvideni razpored cepljenja: 5 mesecev po primarnem in eno leto po tretjem cepljenju.
English: Store and transport refrigerated (2 °C - 8 °C).
Slovenian: Shranjujte in prevažajte v hladilniku 2 °C 8 °C.
English: 2nd scheme - vaccination against equine influenza and tetanus:
Slovenian: Shema 2 - cepljenje proti influenci konj in tetanusu:
English: As a consequence, these components induce immunity against equine influenza virus (H3N8).
Slovenian: ampak izražajo zaščitne proteine, ki spodbudijo imunost proti virusu konjske influence (H3N8).
English: - Revaccination: 5 months after primary vaccination course followed by annual booster injections.
Slovenian: - Revakcinacija: 5 mesecev po primarnem cepljenju, sledi letna revakcinacija.
English: After inoculation, the viruses do not multiply in the horse but express the protective proteins.
Slovenian: Po inokulaciji se virusi v konjih ne razmnožujejo,
English: In very rare occasions, abcessation may be observed.
Slovenian: V zelo redkih primerih se lahko pojavi abscediranje.
English: Carbomer ........................................................................................................................................... 4 mg. For the full list of excipients, see section 6.1.
Slovenian: Karbomer .............................................................................................................................................. 4 mg Celoten seznam pomožnih snovi, glej razdelek 6.1.
English: Onset of immunity: 14 days after primary vaccination course.
Slovenian: Nastop imunosti 14. dan po končanem primarnem cepljenju
English: The vaccine strains vCP2242 and vCP3011 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/eq/Ohio/03 (American strain, Florida sublineage clade 1) and A/eq/Richmond/1/07 (American strain, Florida sublineage clade 2), respectively.
Slovenian: Seva cepiva vCP3011 in vCP2242 sta rekombinantna canarypox virusa, ki izražata hemaglutinin HA gen sevov A/eq/Ohio/03 (ameriški sev, podvrsta Florida 1) oziroma A/eq/Richmond/1/07 (ameriški sev, podvrsta Florida 2) virusa konjske influence.
English: Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ............. ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) .. ≥ 5.3 log10 FAID50*
Slovenian: Influenza A/eq/ Ohio/03 [H3N8] rekombinantni canarypox virus (vCP2242) ............. ≥ 5,3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] rekombinantni canarypox virus (vCP1533) .. ≥ 5,3 log10 FAID50*
English: 1st scheme - vaccination against equine influenza:
Slovenian: Shema 1 - cepljenje proti influenci konj:
English: o against equine influenza: injection of 1 dose every year, alternatively with ProteqFlu or ProteqFlu-Te, respecting an interval of maximum 2 years for the tetanus component.
Slovenian: o Proti tetanusu: 1 odmerek Proteqflu TE največ na vsaki dve leti o Proti influenci konj: 1 odmerek vsako leto, izmenjaje Proteqflu in Proteqflu TE, upoštevajoč največ dve leti razmika za tetanus komponento.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK
English: 1 dose
Slovenian: 1 ml
English: Following the administration of overdoses of vaccine, no side-effects other than those described under “Adverse reactions” have been observed.
Slovenian: Po dajanju prevelikih odmerkov niso ugotovili nobenih drugih stranskih učinkov razen tistih,
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: - Zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: ProteqFlu Suspension for injection for horses
Slovenian: ProteqFlu suspenzija za injiciranje za konje
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection of ProteqFlu can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
Slovenian: V primeru povečanega tveganja okužbe ali nezadostnega zaužitja kolostruma se lahko injicira dodaten začetni odmerek Proteqflu v starosti štirih mesecev, ki mu sledi popoln program cepljenja (prvi odmerek v starosti petih do šestih mesecev, drugi odmerek 4 do 6 tednov pozneje, sledi revakcinacija).
English: PACKAGE LEAFLET FOR: ProteqFlu suspension for injection for horses
Slovenian: NAVODILO ZA UPORABO ProteqFlu suspenzija za injiciranje za konje
English: Administer one dose (1 ml), by intramuscular injection, preferably in the neck region, according to the following schedule: - Primary vaccination course with ProteqFlu-Te: first injection from 5-6 months of age, second injection 4-6 weeks later.
Slovenian: Injicirajte 1 odmerek (1 ml Proteqflu) intramuskularno, priporočljivo v predel vratu, po naslednjem razporedu: - Primarno cepljenje: prvi odmerek pri starosti petih do šestih mesecev, drugi odmerek 4 do 6
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer package for 10 doses: 10 vials of 1 dose
Slovenian: Zunanja ovojnina za 10 odmerkov suspenzije
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta Uporabite takoj po prvem odpiranju.
English: ProteqFlu suspension for injection for horses
Slovenian: ProteqFlu Suspenzija za injiciranje za konje.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: DODATEK II A IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIKDOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
English: • Followed by: o against tetanus: injection of 1 dose at an interval of maximum 2 years with ProteqFlu-Te.
Slovenian: o Proti tetanusu: 1 odmerek Proteqflu TE največ na vsaki dve leti o Proti influenci konj: 1 odmerek vsako leto, izmenjaje Proteqflu in Proteqflu TE,
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 1st scheme - vaccination against equine influenza:
Slovenian: DAJANJA ZDRAVILA Shema 1 - cepljenje proti influenci konj:
English: Type I glass vial.
Slovenian: OVOJNINAH Viala
English: Following the administration of overdoses of vaccine, no side-effects other than those described under section 4.6 have been observed.
Slovenian: Pomožne snovi (vključno z dodatki), navedene v poglavju 6.1.
English: This needs point further discussion.
Slovenian: Ta točka zahteva nadaljnjo razpravo.
English: The mechanism of this syndrome is not understood.
Slovenian: Mehanizma tega sindroma ne poznamo.
English: Bioavailability is 65 to 70 %.
Slovenian: Biološka uporabnost znaša od 65 do 70 %.
English: The treatment should be discontinued one day prior to the surgery.
Slovenian: Zdravljenje morate prekiniti en dan pred operacijo.
English: Efficacy and safety of use in children has not been established.
Slovenian: Učinkovitosti in varnosti uporabe zdravila pri otrocih niso ugotavljali.
English: This effect is anticipated and is usually not a reason to discontinue treatment.
Slovenian: Učinek je pričakovan in običajno ni razlog za prekinitev zdravljenja.
English: This indication was endorsed by several CMS.
Slovenian: To indikacijo je odobrilo več zadevnih držav članic.
English: The dose adjustment should be based on the clinical response of the individual patient.
Slovenian: Prilagajanje odmerka mora temeljiti na kliničnem odzivu posameznega bolnika.
English: It is not known whether perindopril is excreted into human breast milk.
Slovenian: Ni znano, ali se perindopril pri ljudeh izloča v materino mleko.
English: • no untoward safety findings related to the extension of the indication have been identified.
Slovenian: • ugotovljene niso bile nikakršne neugodne ugotovitve v zvezi z varnostjo, povezane z razširitvijo indikacije,
English: This may occur at any time during therapy.
Slovenian: Pojavi se lahko kadarkoli med zdravljenjem.
English: The decrease in blood pressure occurs rapidly.
Slovenian: Znižanje krvnega tlaka nastopi hitro.
English: Results in this population are less convincing and further differentiation of risk may be needed before this patient group can be included in the wording of the indication.
Slovenian: Rezultati pri tej populaciji so manj prepričljivi in pred vključitvijo te skupine bolnikov v besedilo indikacije utegne biti potrebna nadaljnja diferenciacija tveganja.
English: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare (<1/10000), including isolated reports.
Slovenian: zelo pogosti (> 1/10), pogosti (> 1/100, < 1/10), občasni (> 1/1.000, < 1/100), redki (> 1/10.000, < 1/1.000), zelo redki (< 1/10.000), vključno s posameznimi primeri.
English: PHARMACEUTICAL FORM Tablets.
Slovenian: FARMACEVTSKA OBLIKA Tableta.
English: ATC code: C09A A04
Slovenian: Oznaka ATC: C09AA04.
English: • the CHMP considered the referral made under article 6.12 of Commission Regulation (EC) No 1084/2003, for Coversyl and associated names (see Annex I),
Slovenian: • je CHMP preučil napotitev v skladu s členom 6.12 Uredbe Komisije (ES) št. 1084/2003 za zdravilo Coversyl in z njim povezana imena (glej Dodatek I),
English: This wording would be in line with the general CHMP policy regarding products using composite endpoints for evaluation of efficacy.
Slovenian: To besedilo bi se skladalo s splošno politiko CHMP v zvezi z izdelki, ki za ovrednotenje učinkovitosti uporabljajo kombinirani izid.
English: <[To be completed nationally]>
Slovenian: <[Izpolniti nacionalno]>
English: The applicant subsequently sent on 23.02.2005 a Position Paper to all MS stating that the indication proposed by the RMS was not acceptable, and that a broader indication reflecting the study population should be approved, namely:
Slovenian: Zatem je vlagatelj 23.02.2005 poslal vsem državam članicam dokument o stališču, v katerem trdi, da indikacija, ki jo je predlagala referenčna država članica, ni sprejemljiva, ter da bi bilo potrebno odobriti širšo indikacijo, ki se je odražala v raziskovani populaciji, in sicer:
English: Overall conclusion on benefit/risk
Slovenian: Celostni sklep glede razmerja med koristmi in tveganji
English: The Company has provided data showing that this population is not so heterogeneous but quite similar to the whole population included in EUROPE study, at least in terms of revascularisation techniques and concomitant treatments.
Slovenian: Podjetje je predložilo podatke, ki kažejo, da ta populacija ni tako heterogena, temveč precej podobna celotni populaciji, vključeni v študijo EUROPA, in sicer vsaj z vidika revaskularizacijskih tehnik in sočasnega zdravljenja.
English: Evaluation of Clinical Efficacy
Slovenian: Ocena klinične učinkovitosti
English: The volume of distribution is approximately 0.2 l/kg for unbound perindoprilat.
Slovenian: Volumen porazdelitve je pri nevezanem perindoprilatu približno 0,2 l/kg.
English: An official referral for arbitration was notified by the Netherlands to the CHMP on 17.03.2005.
Slovenian: 17.03.2005 je Nizozemska CHMP prijavila uradno napotitev na arbitražo.
English: • the CHMP, as a consequence, considered the benefit/risk balance for the above-mentioned extension of indication to be favourable,
Slovenian: • je CHMP posledično menil, da je razmerje med tveganji in koristmi za zgoraj omenjeno razširitev indikacije ugodno.
English: The following LoQ was adopted by the CHMP in April 2005:
Slovenian: CHMP je aprila 2005 sprejel naslednji seznam vprašanj:
English: • Section 5.1 has been updated to include the results of the EUROPA trial as follows: Patients with stable coronary artery disease:
Slovenian: • Poglavje 5.1 je bilo posodobljeno tako, da vključuje rezultate študije EUROPA kot sledi: Bolniki s stabilno koronarno arterijsko boleznijo:
English: Difficulties in making comparisons among the different trials are recognised as they include a different population and use different endpoints.
Slovenian: Težave pri oblikovanju primerjav med različnimi preizkušanji, glede na to, da vključujejo različne populacije in uporabljajo različne izide, so priznane.
English: Renal blood flow increases as a rule, while the glomerular filtration rate (GFR) is usually unchanged.
Slovenian: Ledvični krvni pretok se praviloma poveča, medtem ko stopnja glomerulne filtracije (GFR) običajno ostaja nespremenjena.
English: Some of these patients developed serious infections, which in a few instances did not respond to intensive antibiotic therapy.
Slovenian: Pri nekaterih od njih so se pojavile resne okužbe, ki se v nekaj primerih niso odzivale na intenzivno zdravljenje z antibiotiki.
English: The results showed that treatment with perindopril once daily resulted in a significant absolute reduction in the primary endpoint.
Slovenian: Rezultati so pokazali, da je zdravljenje s perindoprilom enkrat dnevno privedlo do pomembnega zmanjšanja pogostosti primarnega izida.
English: Perindopril is contraindicated during the second and third trimesters of pregnancy.
Slovenian: Perindopril je kontraindiciran v drugem in tretjem trimesečju nosečnosti.
English: Therefore, use in children is not recommended.
Slovenian: Zato uporaba zanje ni priporočljiva.
English: During the randomised period of the EUROPA study, only serious adverse events were collected.
Slovenian: Med randomiziranim obdobjem študije EUROPA so zbirali le poročila o hudih neželenih učinkih.
English: When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.
Slovenian: Pri vožnji ali upravljanju s stroji morate upoštevati, da se včasih lahko pojavljata omotica ali utrujenost.
English: In responding patients, normalisation is achieved within a month and persists without the occurrence of tachyphylaxis.
Slovenian: Bolniki, ki se odzivajo, dosežejo normalizacijo v enem mesecu in jo ohranjajo brez pojava tahifilaksije.
English: Coversyl and associated names contain perindopril, a well-known, potent angiotensin converting enzyme inhibitor (ACE-I), marketed in France as Coversyl 2 and 4 mg since 1988, the entire European Union, and world-wide in more than 10 countries including USA and Japan.
Slovenian: Zdravilo Coversyl in z njim povezana imena vsebujejo perindopril, dobro znan, učinkovit zaviralec angiotenzinske konvertaze (ACE-I), ki ga tržijo v Franciji kot Coversyl 2 in 4 mg od leta 1988, v celotni Evropski uniji ter po vsem svetu v več kot 10 državah, vključno z ZDA in Japonsko.
English: • A warning has been introduced in Section 4.4:
Slovenian: • V poglavju 4.4 je bilo dodano opozorilo:
English: Non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin ≥ 3 g/day:
Slovenian: Nesteroidni antirevmatiki, vključno z Aspirinom ≥ 3 g na dan:
English: About 20 % of the total quantity of perindopril absorbed is converted into perindoprilat, the active metabolite.
Slovenian: Približno 20 % skupne absorbirane količine perindoprila se pretvori v aktivni presnovek perindoprilat.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EMEA
English: A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion.
Slovenian: Prehoden hipotenzivni odziv ni kontraindikacija za nadaljnje odmerjanje, ki običajno poteka brez težav, potem ko se krvni tlak poveča po povečanju volumna.
English: In patients with normal renal function and no other complicating factors, neutropenia occurs rarely.
Slovenian: Pri bolnikih z normalnim ledvičnim delovanjem in brez drugih oteževalnih dejavnikov se nevtropenija pojavlja le redko.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF COVERSYL AND ASSOCIATED NAMES (see Annex I)
Slovenian: SPLOŠEN POVZETEK ZNANSTVENE OCENE ZDRAVILA COVERSYL IN Z NJIM POVEZANIH IMEN (glej Dodatek I)
English: The CHMP believes that the lack of a statistically significant difference for two of the three components of the composite endpoint in the EUROPA study is not a reason to restrict the indication to a single component, given that a positive and fully consistent trend for these two components is observed.
Slovenian: CHMP meni, da odsotnost statistično pomembne razlike pri dveh od treh elementov kombiniranega izida pri študiji EUROPA ni zadosten razlog za omejitev indikacije na en sam element, upoštevaje dejstvo, da je bil za preostala dva elementa opažen pozitiven in docela konsistenten trend.
English: Consistency for secondary variables was also observed and even a significant effect was shown on the occurrence of heart failure in the overall population.
Slovenian: Opažena je bila tudi konsistentnost sekundarnih spremenljivk, dokazan pa je bila celo pomemben vpliv na pojavljanje srčne odpovedi pri celotni populaciji.
English: It is recommended that <COVERSYL and associated names> is taken once daily in the morning before a meal.
Slovenian: <COVERSYL in sorodna imena> je priporočljivo jemati enkrat na dan zjutraj pred obrokom.
English: The antihypertensive activity is maximal between 4 and 6 hours after a single dose and is sustained for at least 24 hours: trough effects are about 87-100 % of peak effects.
Slovenian: Antihipertenzivni učinek je največji 4 do 6 ur po enkratnem odmerku in traja najmanj 24 ur: najmanjši učinek znaša približno 87 do 100 % največjega učinka.
English: As a consequence, peripheral blood flow increases, with no effect on heart rate.
Slovenian: Posledično se poveča periferni krvni pretok, ne da bi to vplivalo na srčno frekvenco.
English: • The posology in Section 4.2 has been updated as follows:
Slovenian: • Odmerjanje v poglavju 4.2 je bilo posodobljeno kot sledi:
English: If hypotension occurs, the patient should be placed in the shock position.
Slovenian: Če se pojavi hipotenzija, bolnika namestite v položaj za šok.
English: Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy.
Slovenian: Zanj je značilno, da je neproduktiven, trdovraten in izgine po prekinitvi zdravljenja.
English: No carcinogenicity has been observed in long term studies in rats and mice.
Slovenian: V dolgoročnih študijah pri podganah in miših niso opažali nikakršne kancerogenosti.
English: Protein binding is slight (binding of perindoprilat to angiotensin converting enzyme is less than 30 %), but is concentration-dependent.
Slovenian: Vezava na beljakovine je majhna (vezava perindoprilata na angiotenzinsko konvertazo je manjša od 30 %), a odvisna od koncentracije.
English: Limited data are available for overdosage in humans.
Slovenian: O prevelikem odmerjanju pri ljudeh so na voljo le omejeni podatki.
English: United Kingdom Les Laboratoires Servier
Slovenian: Velika Britanija Les Laboratoires Servier
English: The patient should be under close medical supervision until complete and sustained resolution of symptoms has occurred.
Slovenian: Bolnik mora ostati pod strogim zdravniškim nadzorom do popolnega in trajnega izginotja simptomov.
English: The recommended starting dose is 4 mg given once daily in the morning.
Slovenian: Priporočeni začetni odmerek je po 4 mg enkrat na dan, in sicer zjutraj.
English: • Second and third trimesters of pregnancy (see 4.6 “Pregnancy and lactation”).
Slovenian: • Drugo in tretje trimesečje nosečnosti (glejte poglavje 4.6 Nosečnost in dojenje).
English: In the initial type II variation dossier submitted by MRP (FR/H/246/01-02/001), the applicant claimed the following indication: “Stable coronary artery disease: Reduction of risk of cardiovascular events in patients with stable coronary artery disease”.
Slovenian: V prvotni dokumentaciji spremembe tipa II, predloženi po postopku medsebojnega priznavanja (FR/H/246/01-02/001), je vlagatelj predložil zahtevo za naslednjo indikacijo: »Stabilna koronarna arterijska bolezen: Zmanjševanje tveganja kardiovaskularnih dogodkov pri bolnikih s stabilno koronarno arterijsko boleznijo«.
English: Routine monitoring of potassium and creatinine are part of normal medical practice for these patients (see 4.8 “Undesirable effects”).
Slovenian: Rutinsko spremljanje ravni kalija in kreatinina je del običajne medicinske prakse pri tovrstnih bolnikih (glejte poglavje 4.8 Neželeni učinki).
English: As it was expected that the subgroup of patients with a history of revascularisation but with no history of MI was heterogeneous in terms of severity of lesions, revascularisation technique and concomitant treatments, the Applicant was asked to address this issue in order to justify the inclusion of this specific group of patients in the proposed indication.
Slovenian: Glede na pričakovanje, da je podskupina bolnikov z v preteklosti izvedeno revaskularizacijo, ki pa v preteklosti niso imeli MI, heterogena z vidika resnosti lezij, revaskularizacijske tehnike in sočasnega zdravljenja, je bilo od vlagatelja zahtevano, da posebej obravnava to vprašanje, da bi tako utemeljil vključitev te specifične skupine bolnikov v predlagano indikacijo.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINA UPORABE, IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH