FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH demonstrated the bioequivalence with two types of data: an in vivo BE-study (bioequivalence study) with urine measurement and in vitro studies on BA/BE based on Biopharmaceutics Classification System (BCS).
Slovenian: Imetnik dovoljenja za promet z zdravilom je dokazal biološko enakovrednost z dvema vrstama podatkov: z in vivo študijo biološke enakovrednosti z merjenjem urina in z in vitro študijami biološke uporabnosti/biološke enakovrednosti na podlagi biofarmacevtskega klasifikacijskega sistema.
English: Non-clinical pharmacodynamic, pharmacokinetic and toxicological properties of betahistine dihydrochloride are also well known.
Slovenian: Neklinične farmakodinamične, farmakokinetične in toksikološke lastnosti betahistin dihidroklorida so prav tako dobro znane.
English: Germany HENNIG ARZNEIMITTEL GmbH & Co. KG
Slovenian: HENNIG ARZNEIMITTEL GmbH & Co.
English: The MAH has demonstrated that Betavert N (Hennig Arzneimittel GmbH, Germany) and the originator, Betaserc® 8 (Duphar, UK), are bioequivalent after single administration.
Slovenian: Imetnik dovoljenja za promet z zdravilom je dokazal, da sta po enkratni uporabi zdravili Betavert N (Hennig Arzneimittel GmbH, Nemčija) in izvorno zdravilo Betaserc® 8 (Duphar, VB) biološko enakovredni.
English: The control tests and specifications for drug substance product were adequately drawn up.
Slovenian: Kontrolni preskusi in specifikacije učinkovine zdravila so bile zadostno predstavljeni.
English: The solubility of the drug substance and the fast dissolution rate of the drug product have been proven.
Slovenian: Topnost učinkovine zdravila in velika hitrost raztopitve zdravila sta bili dokazani.
English: The active substance Betahistine hydrochloride is described in Ph.Eur.
Slovenian: Zdravilna učinkovina betahistin hidroklorid je opisana v Evropski farmakopeji.
English: The CHMP concluded that betahistine dihydrochloride can be classified as Class I according to Biopharmaceutics Classification System.
Slovenian: CHMP je sklenil, da se betahistin dihidroklorid lahko uvrsti v razred I po biofarmacevtskem klasifikacijskem sistemu.
English: Only traces of desmethylbetahistine dihydrochloride are recovered in the urine.
Slovenian: Desmetil betahistin dihidroklorid se v urinu nahaja le v sledovih.
English: The CHMP, considered these data, concluded that betahistine dihydrochloride can be assigned to the highly soluble class according to Biopharmaceutics Classification System, Class I.
Slovenian: CHMP je ob upoštevanju teh podatkov sklenil, da se betahistin dihidroklorid po biofarmacevtskem klasifikacijskem sistemu lahko uvrsti v visoko topni razred I.
English: Consequently the drug product is eligible for BCS based biowaiver approach.
Slovenian: Posledično je zdravilo primerno za pristop bio-opustitve po biofarmacevtskem klasifikacijskem sistemu.
English: In conclusuion, considering the absorption correlated with high permeability, the allocation of betahistine dihydrochloride to BCS Class I is considered justified by the CHMP.
Slovenian: Za zaključek je CHMP mnenja, da je ob upoštevanju absorpcije v povezavi z visoko prepustnostjo, uvrstitev betahistin dihidroklorida v razred I po biofarmacevtskem klasifikacijskem sistemu utemeljena.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Slovenian: (Izmišljeno) ime
English: This summary was last updated in August 2016.
Slovenian: Povzetek je bil nazadnje posodobljen avgusta 2016.
English: This does not affect the health or performance of the animal.
Slovenian: To ne vpliva na zdravje in zmogljivost živali.
English: EMA/CVMP/193329/2007 EMEA/V/C/000051
Slovenian: EMEA/CVMP/190433/2007 EMEA/V/C/000051
English: The vaccine is given into the neck at the front of the shoulder.
Slovenian: Cepivo se daje v vrat v sprednjem delu ramena.
English: If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Slovenian: Če bolečina ne izgine po več kot 12 urah po zdravniškem pregledu, se je treba ponovno posvetovati z zdravnikom.
English: The virus in the vaccine has also been modified to allow vaccinated animals to be distinguished from naturally infected animals so allowing better disease management.
Slovenian: Virus v cepivu je bil spremenjen tudi tako, da se cepljene živali ločijo od naravno okuženih živali, kar pripomore k boljšemu obvladovanju bolezni.
English: In the future, if the animals are exposed to the active virus the immune system will be able to respond more quickly.
Slovenian: Če so živali v prihodnje izpostavljene virusu, se lahko njihov imunski sistem hitreje odzove.
English: Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger -this could result in the loss of a finger if prompt medical attention is not given.
Slovenian: Nenamerno injiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst na roki - brez takojšnje zdravniške oskrbe lahko pride do izgube prsta.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bovalto Ibraxion's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Bovalto Ibraxion večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The full EPAR for Bovalto Ibraxion can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Bovalto Ibraxion je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The name of the medicine was changed to Bovalto Ibraxion on 10 August 2016.
Slovenian: Ime zdravila je bilo 10. avgusta 2016 spremenjeno v Bovalto Ibraxion.
English: This is a summary of the European public assessment report (EPAR) for Bovalto Ibraxion.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bovalto Ibraxion.
English: Ibraxion may cause a slight rise in body temperature (less than 1°C) for less than 48 hours after injection.
Slovenian: Cepivo lahko povzroči rahel dvig telesne temperature (manj kot 1 C), ki izzveni v manj kot 48 urah po cepljenju.
English: The injection of Bovalto Ibraxion may cause a temporary tissue reaction at the site of injection, which may last for three weeks and rarely up to five weeks.
Slovenian: Injiciranje cepiva Bovalto Ibraxion lahko povzroči začasno reakcijo tkiva na mestu injiciranja, ki lahko traja do treh tednov in redko do pet tednov.
English: Protection starts 2 weeks after vaccination and lasts for 6 months.
Slovenian: Zaščita se začne dva tedna po cepljenju in traja najmanj šest mesecev.
English: The European Commission granted a marketing authorisation valid throughout the EU for Bovalto Ibraxion on 9 March 2000.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Bovalto Ibraxion, veljavno po vsej Evropski uniji, izdala 9. marca 2000.
English: Field studies were conducted in around 300 cattle of various ages in both an IBR contaminated and an IBR free environment.
Slovenian: Terenske študije so izvedli pri približno 300 glavah goveda različnih starosti v obeh okoljih, okuženem z virusom IBR in neokuženem.
English: The withdrawal period for meat and milk from cattle treated with Bovalto Ibraxion is ‘zero' days, which means there is no mandatory waiting time.
Slovenian: Karenca za meso in mleko goveda, zdravljenega z zdravilom Bovalto Ibraxion, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
English: Cattle vaccinated with Bovalto Ibraxion had protective levels of antibodies to IBR virus at 2 weeks after vaccination and the duration of protection was shown to last 6 months.
Slovenian: Pri govedu, cepljenim s cepivom Bovalto Ibraxion, so se zaščitne ravni protiteles proti virusu IBR pojavile po dveh tednih po cepljenju, zaščita pa je trajala šest mesecev.
English: Two injections are given 3 weeks apart to calves from age 2 weeks provided they have not acquired antibodies against IBR virus from the mother.
Slovenian: Cepijo se teleta starejša od dveh tednov z dvema odmerkoma cepiva v razmiku treh tednov, če od matere niso prejela protiteles proti virusu IBR.
English: When there are antibodies the vaccine should be given to calves from age 3 months.
Slovenian: Če so protitelesa prisotna, je treba cepiti teleta v starosti od treh mesecev.
English: Bovalto Ibraxion is an emulsion containing mineral oil.
Slovenian: Zdravilo Bovalto Ibraxion je emulzija, ki vsebuje mineralno olje.
English: When Bovalto Ibraxion is given to cattle the animals' immune system recognises the inactive virus as ‘foreign' and makes antibodies against it.
Slovenian: Ko goveda prejmejo cepivo Bovalto Ibraxion, imunski sistem živali prepozna neaktivirani virus kot „tujek“ ter začne proti njemu tvoriti protitelesa.
English: A booster injection is given at 6 month intervals.
Slovenian: Poživitveno cepivo se daje v šestmesečnih presledkih.
English: IBR virus infections affect the airways with nasal discharge, conjunctivitis (inflammation of the eye) and coughing.
Slovenian: Okužbe z virusom IBR prizadenejo dihalne poti in povzročijo nastanek nosnega izcedka, konjuktivitisa (vnetja oči) in kašlja.
English: For practical information about using Bovalto Ibraxion, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Bovalto Ibraxion naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: What benefits of Bovalto Ibraxion have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Bovalto Ibraxion izkazalo v študijah?
English: For more information about treatment with Bovalto Ibraxion, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Bovalto Ibraxion naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: Bovalto Ibraxion is available as an emulsion and can only be obtained with a prescription.
Slovenian: Zdravilo Bovalto Ibraxion je na voljo v obliki emulzije, njegovo predpisovanje in izdaja pa sta le na recept.
English: Bovalto Ibraxion is a veterinary vaccine used to protect cattle against infectious bovine rhinotracheitis (IBR) virus.
Slovenian: Bovalto Ibraxion je zdravilo za uporabo v veterinarski medicini, ki se uporablja za zaščito goveda pred virusom infekcioznega bovinega rinotraheitisa (IBR).
English: Bovalto Ibraxion is a vaccine containing a version of the IBR virus that has been made inactive so it cannot cause infection.
Slovenian: Zdravilo Bovalto Ibraxion je cepivo, ki vsebuje neaktivirano različico virusa IBR, ki ne more povzročiti okužbe.
English: Why is Bovalto Ibraxion approved?
Slovenian: Zakaj je bilo zdravilo Bovalto Ibraxion odobreno?
English: Bovine rhinotracheitis vaccine (inactivated)
Slovenian: Bovalto Ibraxion cepivo proti bovinemu rinotraheitisu (neaktivirano)
English: What are the risks associated with Bovalto Ibraxion?
Slovenian: Kakšna tveganja so povezana z zdravilom Bovalto Ibraxion?
English: Other information about Bovalto Ibraxion?
Slovenian: Druge informacije o zdravilu Bovalto Ibraxion:
English: Bovalto Ibraxion contains the adjuvant light paraffin oil to enhance the immune response.
Slovenian: Cepivo Bovalto Ibraxion vsebuje kot adjuvans lahko parafinsko olje, ki spodbuja imunski odziv.
English: Bovalto Ibraxion contains the active substance inactivated gene deleted IBR virus.
Slovenian: Zdravilo Bovalto Ibraxion vsebuje kot zdravilno učinkovino neaktivirani virus z delecijo gena IBR.
English: It is not intended to provide practical advice on how to use Bovalto Ibraxion.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: How does Bovalto Ibraxion work?
Slovenian: Kako zdravilo Bovalto Ibraxion deluje?
English: How is Bovalto Ibraxion used?
Slovenian: Kako se zdravilo Bovalto Ibraxion uporablja?
English: What is Bovalto Ibraxion and what is it used for?
Slovenian: Kaj je zdravilo Bovalto Ibraxion in za kaj se uporablja?
English: This product contains mineral oil.
Slovenian: Ta izdelek vsebuje mineralno olje.
English: An alternative solution could be to retain only one production site.
Slovenian: Druga možna rešitev je ohraniti zgolj eno mesto izdelave.
English: > 1:40 HI Units
Slovenian: > 1:40 HI Enot
English: 4.8 Interactions with other medicinal products and other forms of interaction
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: 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 za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: Revaccinate after 3 weeks.
Slovenian: Ponovno cepljenje po treh tednih.
English: Applicant is asked to commit to take appropriate measures to harmonise the productions and/or to provide the adequate demonstrations/data to solve the issues.
Slovenian: Predlagatelja prosimo, da sprejme ustrezne ukrepe za usklajevanje izdelovanja in/ali da priskrbi primerne predstavitve/podatke za rešitev teh vprašanj.
English: With regard to the differences in production and control, harmonization of the production process and the controls between both manufacturing site is strongly suggested.
Slovenian: Glede na razlike v izdelovanju in kontroli, močno priporočamo uskladitev postopkov izdelave in kontrole med obema proizvodnima mestoma.
English: SPECIAL WARNINGS, IF NECESSARY Accidental injection is dangerous.
Slovenian: POSEBNA OPOZORILA, ČE SO POTREBNA Nenamerno injiciranje je nevarno.
English: MRL required
Slovenian: MRL ni zahtevan
English: The Marketing Authorisation Holder shall complete the following programme of studies, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem obdobju izvesti naslednji program študij, katerih rezultati služijo kot osnova za vsakoletno ponovno oceno razmerja korist/tveganje.
English: For use only as a preservative in multidose vaccines at a concentration not exceeding
Slovenian: Le za uporabo v obliki konzervan sa v večodmer nih cepivih pri koncentra ciji, ki ne presega
English: Water in oil adjuvant
Slovenian: Voda v oljnem dodatku
English: Duration of immunity in chickens has not been established yet.
Slovenian: Čas trajanja imunske zaščite pri piščancih še ni potrjena.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the 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 države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
English: Do not mix with any other medicinal product.
Slovenian: Ne mešajte z drugimi zdravili.
English: Pfizer Animal Health 2000 Rockford Road Charles City, Iowa 50616 USA
Slovenian: Pfizer Animal Health 2000 Rockford Road Charles City, Iowa 50616 ZDA
English: QUALITY ASPECTS
Slovenian: VIDIKI KVALITETE
English: Any person intending to import, sell, supply and/or use Poulvac FluFend H5N3 RG must consult the relevant Member States 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 Poulvac FluFend H5N3 RG, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ali uporabo.
English: All food producing species
Slovenian: Vse vrste za proizvodnj o živil
English: Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom
Slovenian: Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ Združeno kraljestvo
English: In particular, a rationalization of the nature of eggs used (taking into consideration the problem of the possible presence of extraneous agents in conventional eggs and the possibility to inactivate them during the inactivation process of the Influenza virus, supported by a corresponding validation study).
Slovenian: To velja še posebej pri racionalizaciji lastnosti uporabljenih jajc (ob upoštevanju problema morebitne prisotnosti tujih dejavnikov v običajnih jajcih in možnosti inaktivacije le-teh med postopkom inaktivacije virusa influence, kar podpira ustrezna validacijska študija).
English: The vaccination schedule should be completed at least 4 weeks before the start of laying.
Slovenian: Program cepljenja bi se moral zaključiti vsaj 4 tedne pred začetkom obdobja nesnosti.
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.
Slovenian: Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena le pod posebnimi pogoji, ki jih določa zakonodaja Evropske skupnosti o aviarni influenci.
English: The vaccine is presented in boxes of 1 or 10 bottles of 500 ml.
Slovenian: Cepivo je v škatlah z 1 ali 10 plastenkami po 500 ml.
English: PHARMACEUTICAL FORM Emulsion for injection.
Slovenian: FARMACEVTSKA OBLIKA Emulzija za injiciranje.
English: The import, sale, supply and/or use of Poulvac FluFend H5N3 RG 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 Poulvac FluFend H5N3 RG 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: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Slovenian: Imetnik tega dovoljenja za promet mora o načrtih prometa z zdravilom, ki je bilo odobreno s tem odlokom, obvestiti Evropsko Komisijo.
English: The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains.
Slovenian: Nivo dosežene učinkovitosti lahko variira glede na stopnjo antigenske homolognosti med sevom v cepivu in sevi v okolju.
English: Keep in the original container in order to protect from light.
Slovenian: Shranjujte v originalni ovojnini za zaščito pred svetlobo.
English: ADVICE ON CORRECT ADMINISTRATION Do not mix with any other medicinal product.
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Ne mešajte z drugimi zdravili.
English: Excludes aromatic and unsaturated compounds
Slovenian: Izključene aromatičn e in nesaturira ne sestavine
English: Pharmacotherapeutic group: Inactivated recombinant vaccine, ATC vet code: QI01AA23
Slovenian: Farmakoterapevtska skupina: Inaktivirano rekombinantno cepivo, ATCvet oznaka: QI01AA23
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: D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Zdravilna učinkovina biološkega izvora namenjena za vzpodbudo aktivne imunosti ni vključena v Uredbo(ES) št. 470/2009.
English: Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Slovenian: Čeprav je bila injicirana le majhna količina, lahko nenamerno injiciranje tega izdelka povzroči močno oteklino, ki lahko na primer privede do ishemične nekroze ter celo do izgube prsta.
English: The entire content of the bottle should be used within 2 hours after broaching the container.
Slovenian: Vsebino plastenke morate porabiti v dveh urah po predrtju vsebnika.
English: Avoid stress in the birds around the time of vaccination.
Slovenian: V času cepljenja ptice varujte pred stresom.
English: 1) There are important outstanding issues regarding the differences of production and control between the manufacturing sites (including the nature of the eggs used) and the lack of a validation study for the potency test on finished product (it appears that final product tests are only done at Weesp but in-process tests such as titration and HA quantification need to be equivalent too).
Slovenian: 1) Obstajajo pomembna nerešena vprašanja glede razlik med izdelavo in nadzorom v različnih proizvodnih obratih (vključno z lastnostmi uporabljenih jajc) in ni validacijske študije za test moči (potency test) na končnem izdelku (zdi se, da se testi končnega cepiva izvajajo le v
English: PACKAGE SIZE 500 ml
Slovenian: VELIKOST PAKIRANJA 500 ml
English: A transient local site reaction (swelling) may occasionally occur as is normal with oil adjuvanted vaccines.
Slovenian: Občasno se lahko pojavi prehodna lokalna reakcija (otekanje), kot je običajno za cepiva, kjer je dodatek olje.
English: White Oil
Slovenian: Belo olje
English: Mineral hydrocarbons, low to high viscosity including microcrystalline waxes, approximately C10-C60, aliphatic, branched aliphatic and alicyclic compounds
Slovenian: Hidrokarbon, mineralni, nizke do visoke viskoznosti vključuje voske, mikrokristalinične, okoli C10-C60, alifatične, razvejane alifatične in aliciklične sestavine
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POTI IN NAČIN UPORABE ZDRAVILA
English: Name and address of the manufacturer of the biological active substance(s)
Slovenian: Ime in naslov izdelovalca(izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin).
English: Chickens and ducks.
Slovenian: Piščanci in race.
English: Emulsion for injection for chickens and ducks
Slovenian: Emulzija za injiciranje za piščance in race
English: 3 weeks of age or older: 0.5 ml intramuscularly in the breast muscle.
Slovenian: Starost treh tednov ali več: 0,5 ml intramuskularno v prsno mišico.
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes 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 b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Slovenian: a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih izdelkih, pridobljenih iz zdravljenih živali,
English: E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Slovenian: E. POSEBNE ZAHTEVE, KI JIH MORA IZPOLNJEVATI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Onset of immunity: 3 weeks after the second injection.
Slovenian: Nastop imunosti: Tri tedne po drugi injekciji.
English: If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Slovenian: Če vam je bil ta proizvod nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodila za uporabo.
English: 1 year.
Slovenian: Nič dni.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/060/001-002
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/060/001-002
English: SPECIAL STORAGE CONDITIONS
Slovenian: Posebna navodila za shranjevanje