FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF RENEWAL OF THE AUTHORISATION To be completed nationally
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: • Escherichia coli (including β-lactamase producing strains).
Slovenian: • Escherichia coli (vključno s sevi, ki tvorijo laktamaze beta).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Polyethylene syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: • Escherichia coli (including β-lactamase producing strains) A review of the susceptibility of the mastitis pathogens against amoxicillin-clavulanic acid indicates that the major bacterial causes of bovine mastitis continue to be susceptible to clavulanate potentiated amoxicillin.
Slovenian: Pregled občutljivosti povzročiteljev mastitisa za kombinacijo amoksicilina in klavulanske kisline kaže, da so poglavitni bakterijski povzročitelji bovinega mastitisa še vedno občutljivi za amoksicilin v kombinaciji s klavulanatom.
English: However it was noted that the self-cure effect was not considered regarding
Slovenian: Vendar je bilo ugotovljeno, da v primerih okužb z Escherichia coli ni bil upoštevan učinek samoozdravitve.
English: Amoxicillin (as amoxicillin trihydrate) Clavulanic acid (as potassium clavulanate) Prednisolone
Slovenian: Amoxicillin (as amoxicillin trihydrate) Clavulanic acid (as potassium clavulanate) Prednisolone intramamarna suspenzija govedo Užitna tkiva: 4 dni
English: Meat and offal: 7 days Milk: 84 hours.
Slovenian: Meso in organi: 7 dni Mleko: 84 ur, t.j.
English: Potassium clavulanate equivalent to clavulanic acid
Slovenian: Zdravilne učinkovine amoksicilin trihidrat, ekvivalenten amoksicilinu kalijev klavunalat, ekvivalenten klavulanski kislini prednizolon
English: 4.4 Special warnings
Slovenian: 4.3 Kontraindikacije
English: Consequently the CVMP considered that since the added value of prednisolone in the product has not been demonstrated, the following statement in the SPC under section 5.
Slovenian: Posledično je CVMP menil, da se zaradi nedokazane dodane vrednosti prednizolona v zdravilu naslednja izjava v poglavju 5 povzetka glavnih značilnosti zdravila Farmakološke lastnosti: „Prednizolon je glukokortikoid s protivnetnimi lastnostmi.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT “Product name” (to be completed nationally
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
English: 10 mg
Slovenian: odmerek (3 g)
English: Milk (cows milked twice daily): 60 hours (i.e. at the 5th milking) after the last treatment.
Slovenian: Mleko (2-krat dnevna molža): 60 ur (t.j.
English: OTHER INFORMATION To be completed nationally
Slovenian: Izpolni država članica
English: Staphylococci (including -lactamase producing strains) Streptococci (including S.agalactiae, S.dysgalactiae and S.uberis) Escherichia coli (including -lactamase producing strains)
Slovenian: Za zdravljenje kliničnih primerov mastitisa, vključno s primeri, povezanimi z okužbo z naslednjimi povzročitelji: stafilokoki (vključno s sevi, ki proizvajajo β-laktamazo), streptokoki (vključno s Streptococcus agalactiae, S. dysgalactiae in S. uberis), Escherichia coli (vključno s sevi, ki proizvajajo β-laktamazo)
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
English: Synulox
Slovenian: amoksicilin
English: Swab teat end with appropriate disinfectant before treatment.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Pred zdravljenjem razkužite vrh seska s primernim razkužilom.
English: WITHDRAWAL PERIOD Withdrawal period:
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Amoxicillin was the limiting active substance to determine the withdrawal period in milk.
Slovenian: Omejitvena zdravilna učinkovina za določitev karence za mleko je bil amoksicilin.
English: Staphylococci (including -lactamase producing strains) Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis) Arcanobacteria (including A. pyogenes)
Slovenian: Kombinacija amoksicilina in klavulanske kisline deluje in vitro proti širokemu spektru klinično pomembnih bakterij, vključno z naslednjimi običajnimi povzročitelji mastitisa pri govedu: stafilokoki (vključno s sevi, ki proizvajajo β-laktamazo), streptokoki (vključno s S. agalactiae, S. dysgalactiae in S. uberis), Arcanobacteria (vključno z A. pyogenes)
English: - 2nd injection: after 3-4 weeks.
Slovenian: - Drugi odmerek: po 3-4 tednih.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control and 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.
Slovenian: a) bi uporaba zdravila ovirala izvajanje nacionalnega programa 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.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal product on the whole or part of their territory if it is established that:
Slovenian: Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta, država članica v skladu z nacionalno zakonodajo prepove ali lahko prepove proizvodnjo, uvoz, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
English: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom
Slovenian: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Združeno kraljestvo
English: The import, sale, supply and/or use of BTVPUR AlSap 8 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Slovenian: Uvoz, prodaja, oskrba in/ali uporaba BTVPUR AlSap 8 je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
English: Any person intending to import, sell, supply and/or use BTVPUR AlSap 8 must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Slovenian: Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati BTVPUR AlSap 8, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred vnosom/uvozom, prodajo, oskrbo in/ali uporabo.
English: Each dose of 1 ml of vaccine contains:
Slovenian: Vsak odmerek (1 ml) cepiva vsebuje:
English: Vaccination may be followed by a small local swelling at the injection site (at most 32 cm²) for a short period (at most 14 days).
Slovenian: Po cepljenju se lahko na mestu dajanja pojavi prehodna manjša lokalizirana oteklina (največ 32 cm²), ki hitro izgine (v največ 14 dneh).
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini po EXP.
English: In cattle and sheep - 1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young cattle and sheep born to immune animals).
Slovenian: Govedo in ovce - Prvi odmerek: od 1 meseca starosti pri predhodno necepljenih živalih (ali od 2,5 meseca starosti pri potomcih imunih krav in ovc).
English: 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.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št. 470/2009.
English: BATCH NUMBER Lot{number}
Slovenian: ŠTEVILKA SERIJE Lot {številka}
English: The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.
Slovenian: Trajanje imunosti pri govedu in ovcah je eno leto po osnovnem cepljenju.
English: Aluminium hydroxide Purified saponin Silicon antifoam Phosphate buffer Glycine buffer Water for injection
Slovenian: Aluminijev hidroksid Prečiščen saponin Silikon (proti penjenju) Fosfatni pufer Glicerinski pufer Voda za injiciranje
English: Sheep and cattle
Slovenian: Ovce in govedo.
English: TARGET SPECIES Sheep and cattle.
Slovenian: CILJNE ŽIVALSKE VRSTE Ovce in govedo.
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double- dose of the vaccine.
Slovenian: Drugi učinki, razen tistih ki so navedeni v poglavju 4.6, niso bili opaženi po dajanju dvakratnega odmerka cepiva.
English: A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Slovenian: Do 24 ur po cepljenju je možen pojav prehodnega povišanja telesne temperature, ki navadno ne preseže 1.1 °C.
English: Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle).
Slovenian: Farmakoterapevtska skupina: cepivo proti virusu modrega jezika; oznaka ATCvet QI04AA02 (ovce) in QI02AA08 (govedo).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/094/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/094/001
English: Can be used during pregnancy and lactation in cows.
Slovenian: Lahko se uporablja v obdobju brejosti in laktacije pri kravah.
English: 4.11 Withdrawal period Zero days.
Slovenian: 4.11 Karenca Nič dni.
English: Shelf life after first opening the immediate packaging: immediately after broaching.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: takoj po prvem odpiranju.
English: The safety and the efficacy of the vaccine has not been established in breeding males.
Slovenian: Varnost in učinkovitost cepiva nista bili ugotovljena pri plemenjakih.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: Ni podatkov o varnosti ter učinkovitosti cepiva ob istočasnem dajanju katerega koli drugega zdravila za uporabo v veterinarski medicini.
English: * (below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission)
Slovenian: * (pod stopnjo detekcije z validirano metodo RT-PCR pri 3,14 log10 RNA kopijah/ml, ni prenosavirusa)
English: *below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission
Slovenian: *pod stopnjo detekcije z validirano metodo RT-PCR pri 3,14 log10 RNA kopijah/ml, ni prenosa virusa
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C-8 °C).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku (2 °C-8 °C).
English: Polypropylene bottle of 50 or 100 ml with butyl elastomere closure.
Slovenian: 50 ali 100 ml polipropilenska plastenka z butil elastomerno zaporko.
English: No adverse reactions except those mentioned in section ‘Adverse Reactions' were observed after the administration of a double-dose of vaccine.
Slovenian: Drugi učinki, razen tistih, ki so navedeni v poglavju neželeni učinki, niso bili opaženi po dajanju dvojnega odmerka cepiva.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Slovenian: Za pomožne snovi, navedene v poglavju 6.1 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: 1 bottle of 10 doses (1 x 10 ml) 1 bottle of 50 doses (1 x 50 ml) 10 bottles of 50 doses (10 x 50 ml) 1 bottle of 100 doses (1 x 100 ml) 10 bottles of 100 doses (10 x 100 ml)
Slovenian: 1 steklenička z 10 odmerki (1 x 10 ml) 1 plastenka s 50 odmerki (1 x 50 ml) 10 plastenk s 50 odmerki (1 x 50 ml) 1 plastenka s 100 odmerki (1 x 100 ml) 10 plastenka s 100 odmerki (1 x 100 ml)
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Slovenian: Pri tej kategoriji živali je potrebno cepivo uporabljati glede na presojo razmerja korist/tveganje odgovornega veterinarja oziroma v skladu z veljavnimi smernicami pristojnih nacionalnih organov glede cepljenja proti bolezni modrega jezika (BTV).
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue virus (BTV).
Slovenian: Pri tej kategoriji živali je potrebno cepivo uporabljati glede na presojo razmerja korist/tveganje odgovornega veterinarja oziroma v skladu z veljavnimi smernicami kompetentnih nacionalnih organov glede cepljenja proti bolezni modrega jezika (BTV).
English: Shelf life of the veterinary medicinal product as package for sale (50-ml and 100-ml bottles): 2 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo (50 ml in 100 ml stekleničke): 2 leti.
English: Type I glass bottle of 10 ml with butyl elastomere closure.
Slovenian: 10 ml steklenička (steklo tipa I) z butil elastomerno zaporko.
English: SC. Read the package leaflet before use.
Slovenian: SC. Pred uporabo preberite navodilo za uporabo.
English: Bluetongue virus serotype 8 antigen ........................................................................... ≥ 2.1 log10 pixels* (*) Antigen content (VP2 protein) by immuno-assay Adjuvants:
Slovenian: Virus modrega jezika, serotip 8, antigen .................................................................. ≥ 2,1 log10 pikslov* (*) Vsebnost antigena (VP2 protein) z imunološkim preskusom Dodatki:
English: Box of 1 bottle of 10 ml Box of 1 bottle of 50 ml, Box of 10 bottles of 50 ml, Box of 1 bottle of 100 ml, Box of 10 bottles of 100 ml
Slovenian: Škatla z 1 stekleničko z 10 ml Škatla z 1 plastenko s 100 ml Škatla z 10 plastenkami po 100 ml Škatla z 1 plastenko s 50 ml Škatla z 10 plastenkami 50 ml
English: Shelf life of the veterinary medicinal product as package for sale (10-ml bottle): 18 months.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo (10 ml stekleničke): 18 mesecev.
English: The vaccine contains inactivated bluetongue virus serotype 8 with aluminium hydroxide and saponin adjuvants.
Slovenian: Cepivo vsebuje inaktiviran virus modrega jezika, serotip 8, z aluminijevim hidroksidom in saponini kot adjuvansi.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Aluminium hydroxide .................................................................................................................... 2.7 mg Saponin ........................................................................................................................................ 30 HU** (**) Haemolytic units
Slovenian: Aluminijev hidroksid ...................................................................................................................... 2,7 mg Saponin ........................................................................................................................................ 30 HU** (**) Hemolizne enote
English: NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 8 suspension for injection
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI BTVPUR AlSap 8 suspenzija za injiciranje
English: Bluetongue virus serotype 8 antigen ........................................................................... ≥ 2.1 log10 pixels* Aluminium hydroxide .................................................................................................................... 2.7 mg Saponin ........................................................................................................................................ 30 HU** (*) antigen content (VP2 protein) by immuno-assay (**) Haemolytic units
Slovenian: Virus modrega jezika, serotip 8, antigen .................................................................. ≥ 2,1 log10 pikslov* Aluminijev hidroksid ..................................................................................................................... 2,7 mg Saponin ....................................................................................................................................... 30 HU** (*) Vsebnost antigena (VP2 protein) v imunološkem preskusu (**) Hemolizne enote
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml of vaccine contains Bluetongue virus serotype 8 antigen ................. ≥ 2.1 log10 pixels
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Vsak odmerek (1 ml) cepiva vsebuje: virus modrega jezika, serotip 8, antigen ...................................................................... ≥ 2,1 log10 pikslov
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml of vaccine contains: BTV8 antigen............................................... ≥ 2.1 log10 pixels* Aluminium hydroxide, Saponin, qs 1 dose (*) (*) see package leaflet
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Vsak odmerek (1 ml) cepiva vsebuje: antigen BTV8 ............................................... ≥ 2,1 log10 pikslov* Aluminijev hidroksid, Saponin q.s.
English: PACKAGE LEAFLET FOR: BTVPUR AlSap 8 suspension for injection
Slovenian: NAVODILO ZA UPORABO BTVPUR AlSap 8 suspenzija za injiciranje
English: Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by Bluetongue virus serotype 8 (BTV 8).
Slovenian: Aktivna imunizacija ovac in goveda proti virusu modrega jezika, serotip 8 (BTV8), za preprečitev viremije* in zmanjšanje kliničnih znakov.
English: It induces an active and specific immunity against Bluetongue virus serotype 8 in the vaccinated animal.
Slovenian: Pri cepljeni živali sproži nastanek aktivne in specifične imunosti proti virusu modrega jezika, serotip 8.
English: Box of 1 bottle of 10 doses (1 x 10 ml).
Slovenian: Škatlica z 1 stekleničko z 10 odmerki (1 x 10 ml).
English: It induces an active and specific immunity against bluetongue virus serotype 8 in the vaccinated animal.
Slovenian: Pri cepljeni živali povzroči nastanek aktivne in specifične imunosti proti virusu modrega jezika, serotip 8.
English: 4.2 Indications for use, specifying the target species Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
Slovenian: Aktivna imunizacija ovac in goveda proti virusu modrega jezika, serotip 8, za preprečitev viremije* in zmanjšanje kliničnih znakov.
English: Box of 10 bottles of 50 doses (10 x 50 ml).
Slovenian: Škatla z 10 plastenkami s 50 odmerki (10 x 50 ml).
English: Box of 1 bottle of 50 doses (1 x 50 ml).
Slovenian: Škatla z 1 plastenko s 50 odmerki (1 x 50 ml).
English: Shake gently immediately before use.
Slovenian: Po odprtju uporabite takoj.
English: Box of 10 bottles of 100 doses (10 x 100 ml).
Slovenian: Škatla z 10 plastenkami s 100 odmerki (10 x 100 ml).
English: Box of 1 bottle of 100 doses (1 x 100 ml).
Slovenian: Škatla z 1 plastenko s 100 odmerki (1 x 100 ml).
English: WITHDRAWAL PERIOD Zero days.
Slovenian: KARENCA Nič dni.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) BTV 8 antigen ...................................................................................................... ≥ 2.1 log10 pixels/dose
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Antigen BTV8 ..............................................................................................≥ 2,1 log10 pikslov/odmerek
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml
Slovenian: PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Plastenka s 100 ml
English: The Reference Member States were Portugal, Slovenia, and the United Kingdom.
Slovenian: Zadevne države članice so bile Portugalska, Slovenija in Združeno kraljestvo.
English: During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names, that the objections raised by should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Slovenian: Med svojim zasedanjem junija 2006 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Doxazosin Retard »Arrow« 4 mg tablete s podaljšanim sproščanjem in povezana imena ugodno, ter da podani ugovori ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo referenčne države članice dopolniti.
English: The scope of the referral was to agree whether Doxazosin Retard “Arrow” 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Slovenian: Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Doxazosin Retard »Arrow« 4 mg tablete s podaljšanim sproščanjem, kar se tiče profila sproščanja, pomembno razlikuje od originatorjevega zdravila, in ali je možnost pojavov neželenih učinkov, kot so omotica in hipotenzija, morebiti povečana; nadalje ali so bile razlike v rezultatih iz študij 5208 in 1995 testnih serij pri enkratnem odmerjanju pomembne, ter končno ali se je vlagatelj oddaljil od smernic CHMP o načrtovanju bioekvivalenčnih raziskav, zlasti kar se tiče učinka, ki bi ga lahko imela hrana.
English: Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names (Doxazosin) is is receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Slovenian: Doxazosin Retard »Arrow« 4 mg tablete s podaljšanim sproščanjem in povezana imena (Doxazosin) vsebujejo snov, ki blokira receptor alfa in se uporablja za zdravljenje bolnikov z esencialno hipertenzijo in simptomatično zdravljenje bolnikov z benigno hiperplazijo prostate.
English: Arrow Generics UK Ltd submitted applications for mutual recognition of Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002.
Slovenian: Družba Arrow Generics UK Ltd je podala vloge za medsebojno priznavanje zdravila Doxazosin Retard »Arrow« 4 mg tablete s podaljšanim sproščanjem in povezana imena na podlagi dovoljenja za promet z zdravilom, ki ga je izdala Danska dne 30. septembra 2002.