FrancophonIA/ELRC3.0 huggingface dataset:
English: More cases have been reported with subcutaneous (SC) route of administration, compared with the IV route.
Slovenian: Pri subkutani uporabi so poročali o več primerih kot pri intravenski uporabi.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj pogosti kongestija dihal občasni
English: Haemoglobin (g/L)
Slovenian: ≤ 12 g/dl
English: 28 patches (7x 2mg/24h, 7x 4mg/24h, 7x 6mg/24h, 7x 8mg/24h)
Slovenian: Transdermalni obliž transdermalnih obližev (7x 2mg/24h, 7x 4mg/24h, 7x 6mg/24h, 7x 8mg/24h)
English: Transdermal patch Transdermal use sachet (paper/LDPE/alu/ET copolymer PE/Alu/ ET copolymer/paper)
Slovenian: Pot uporabe Stična ovojnina
English: 24 October 2011
Slovenian: 24. oktober 2011
English: The European Commission issued a decision on 24 October 2011.
Slovenian: Evropska komisija je sklep izdala dne 24. oktobra 2011.
English: It is available as an oral solution (0.4 mg/ml).
Slovenian: Na voljo je v obliki peroralne raztopine (0,4 mg/ml).
English: EMA/863769/2011 Rev.1 EMEA/H/A-29/1308
Slovenian: EMA/CHMP/582483/2011 rev.1 EMEA/H/A-29/1308
English: However, the Member States were not able to reach an agreement and the Maltese medicines regulatory agency referred the matter to the CHMP for arbitration on 30 May 2011.
Slovenian: Vendar države članice niso mogle doseči soglasja in malteška regulativna agencija za zdravila je dne 30. maja 2011 zadevo napotila na CHMP v arbitražo.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Malta) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Bulgaria, Cyprus, Germany, Greece, Portugal, Romania and the United Kingdom).
Slovenian: To je postopek, ko ena država članica („referenčna država članica“, v tem primeru Malta) presoja zdravilo z vidika odobritve dovoljenja za promet, ki bo veljavno v omenjeni državi in v drugih državah članicah („zadevne države članice“, v tem primeru Belgija, Bolgarija, Ciper, Nemčija, Grčija, Portugalska, Romunija in Združeno Kraljestvo).
English: EMA/863769/2011
Slovenian: EMA/CHMP/582483/2011
English: Dexamethasone Alapis is intended for use principally as an anti-inflammatory or immunosuppressant (a medicine that reduces the activity of the immune system) in a range of specific disorders affecting different parts of the body, including the blood, liver, kidney, stomach and gut, muscles, eye, lungs and skin, as well as in certain cancers and in the management of anaphylaxis (severe allergic reaction).
Slovenian: Zdravilo Dexamethasone Alapis se uporablja predvsem kot protivnetno in imunosupresivno zdravilo (zdravilo, ki zmanjša aktivnost imunskega sistema) pri številnih boleznih, ki prizadenejo različne dele telesa, vključno s krvjo, jetri, ledvicami, želodcem in črevesjem, mišicami, očmi, pljuči in kožo, ter pri določenih vrstah raka in obvladovanju anafilakse (hude alergijske reakcije).
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Dexamethasone Alapis.
Slovenian: Evropska agencija za zdravila je zaključila arbitražni postopek po nestrinjanju držav članic Evropske unije (EU) glede odobritve zdravila Dexamethasone Alapis.
English: It works by entering cells and blocking the production of vascular endothelial growth factor (VEGF) and prostaglandins, substances that are involved in inflammation and swelling.
Slovenian: Deluje tako, da vstopi v celico in zavira nastajanje žilnega endotelnega rastnega faktorja (VEGF) in prostaglandinov, snovi, ki sodelujejo pri vnetju in otekanju.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Dexamethasone Alapis outweigh its risks, and the marketing authorisation can be granted in Malta and in the following Member States of the EU: Belgium, Bulgaria, Cyprus, Germany, Greece, Portugal, Romania and the United Kingdom.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Dexamethasone Alapis odtehtajo z njim povezana tveganja in da se lahko dovoljenje za promet z zdravilom odobri na Malti in v naslednjih državah članicah Evropske unije: Belgiji, Bolgariji, na Cipru, v Nemčiji, Grčiji, na Portugalskem, v Romuniji in Združenem kraljestvu.
English: Why was Dexamethasone Alapis reviewed?
Slovenian: Zakaj je bilo zdravilo Dexamethasone Alapis pregledano?
English: The German medicines regulatory authority was of the opinion that the data submitted to support the application did not provide sufficient evidence to demonstrate the safety and effectiveness of Dexamethasone Alapis.
Slovenian: Nemška regulativna agencija za zdravila je menila, da podatki, predloženi v podporo vlogi, ne dokazujejo varnosti in učinkovitosti zdravila Dexamethasone Alapis v zadostni meri.
English: What is Dexamethasone Alapis?
Slovenian: Kaj je zdravilo Dexamethasone Alapis?
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted was sufficient to show that Dexamethasone Alapis could be used safely and effectively based on the well established use of dexamethasone.
Slovenian: CHMP je po vrednotenju trenutno razpoložljivih podatkov in znanstveni razpravi v Odboru menil, da predloženi podatki zadostujejo za dokaz, da se lahko zdravilo Dexamethasone Alapis uporablja varno in učinkovito na osnovi dobro uveljavljene uporabe deksametazona.
English: The CHMP concluded that the benefits of Dexamethasone Alapis outweigh its risks, and therefore the marketing authorisation for Dexamethasone Alapis should be granted in all concerned Member States.
Slovenian: CHMP je zato zaključil, da koristi zdravila Dexamethasone Alapis odtehtajo z njim povezana tveganja, zato se lahko dovoljenje za promet odobri v vseh zadevnih državah članicah.
English: The active substance in Dexamethasone Alapis, dexamethasone, belongs to a group of anti-inflammatory medicines known as corticosteroids.
Slovenian: Zdravilna učinkovina v zdravilu Dexamethasone Alapis, deksametazon, spada v skupino protivnetnih zdravil, imenovanih kortikosteroidi.
English: Dexamethasone Alapis is a medicine that contains the active substance dexamethasone.
Slovenian: Dexamethasone Alapis je zdravilo, ki vsebuje zdravilno učinkovino deksametazon.
English: The grounds for the referral were that the application, which was supported by published literature rather than studies carried out with Dexamethasone Alapis, because dexamethasone has a history of well-established use in the EU for at least 10 years, was mainly supported by literature demonstrating the safety and efficacy of dexamethasone in tablet form rather than oral solution form and the bridging data provided were not considered adequate to conclude on the benefit-risk profile of the oral solution form.
Slovenian: Deksametazon ima dobro uveljavljeno uporabo v EU že vsaj 10 let, zato je bila vloga podprta z objavljeno literaturo in ne študijami, opravljenimi z zdravilom Dexamethasone Alapis, podlaga za napotitveni postopek pa je bilo zlasti dejstvo, da ji je bila v podporo predložena literatura, ki dokazuje varnost in učinkovitost deksametazona v obliki tablet in ne v obliki peroralne raztopine, pri čemer pa predloženi premostitveni podatki niso bili zadostni za sklep o razmerju med tveganji in koristmi peroralne raztopine.
English: Alapis S.A. submitted Dexamethasone Alapis to Malta for a decentralised procedure.
Slovenian: Družba Alapis S.A. je za zdravilo Dexamethasone Alapis na Malti predložila vlogo za decentraliziran postopek.
English: Further information can be found in the summary of the risk management plan.
Slovenian: Dodatne informacije so na voljo v povzetku načrta obvladovanja tveganj
English: The full EPAR and risk management plan summary for Pemetrexed Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Pemetrexed Sandoz sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Sandoz has been shown to be comparable to Alimta.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Pemetrexed Sandoz primerljivo z zdravilom Alimta.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Sandoz.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pemetrexed Sandoz.
English: This means that Pemetrexed Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Alimta.
English: The Committee recommended that Pemetrexed Sandoz be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Pemetrexed Sandoz odobri za uporabo v EU.
English: Because Pemetrexed Sandoz is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Pemetrexed Sandoz generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Sandoz?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pemetrexed Sandoz?
English: Pemetrexed Sandoz is a cancer medicine used to treat two types of lung cancer:
Slovenian: Pemetrexed Sandoz je zdravilo proti raku, ki se uporablja za zdravljenje dveh vrst pljučnega raka:
English: A risk management plan has been developed to ensure that Pemetrexed Sandoz is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Pemetrexed Sandoz je bil pripravljen načrt obvladovanja tveganj.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Pemetrexed Sandoz in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For more information about treatment with Pemetrexed Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pemetrexed Sandoz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using Pemetrexed Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Pemetrexed Sandoz naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: What are the benefits and risks of Pemetrexed Sandoz?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Pemetrexed Sandoz?
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Sandoz.
Slovenian: Da bi zmanjšali neželene učinke, morajo bolniki med zdravljenjem z zdravilom Pemetrexed Sandoz jemati kortikosteroid (vrsto zdravila, ki ublaži vnetje) in folno kislino (vrsto vitamina) ter prejemati injekcije vitamina B12.
English: When Pemetrexed Sandoz is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Slovenian: Kadar se zdravilo Pemetrexed Sandoz daje v kombinaciji s cisplatinom, je treba pred odmerkom cisplatina ali po njem bolniku dati tudi „antiemetično“ zdravilo (za preprečevanje bruhanja) in tekočino (za preprečevanje dehidracije).
English: Pemetrexed Sandoz is a ‘generic medicine'.
Slovenian: Zdravilo Pemetrexed Sandoz je „generično zdravilo“.
English: The active substance in Pemetrexed Sandoz, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Slovenian: Zdravilna učinkovina v zdravilu Pemetrexed Sandoz, pemetreksed, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot na primer rakave celice) iz skupine „antimetabolitov“.
English: Other information about Pemetrexed Sandoz
Slovenian: Druge informacije o zdravilu Pemetrexed Sandoz
English: What is Pemetrexed Sandoz and what is it used for?
Slovenian: Kaj je zdravilo Pemetrexed Sandoz in za kaj se uporablja?
English: Pemetrexed Sandoz is available as a powder that is made up into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Pemetrexed Sandoz je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalno infuzijo) v veno.
English: Pemetrexed Sandoz pemetrexed
Slovenian: Pemetrexed Sandoz pemetreksed
English: It is not intended to provide practical advice on how to use Pemetrexed Sandoz.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Pemetrexed Sandoz approved?
Slovenian: Zakaj je bilo zdravilo Pemetrexed Sandoz odobreno?
English: Pemetrexed Sandoz contains the active substance pemetrexed.
Slovenian: Zdravilo Pemetrexed Sandoz vsebuje zdravilno učinkovino pemetreksed.
English: How is Pemetrexed Sandoz used?
Slovenian: Kako se zdravilo Pemetrexed Sandoz uporablja?
English: How has Pemetrexed Sandoz been studied?
Slovenian: Kako je bilo zdravilo Pemetrexed Sandoz raziskano?
English: No additional studies were needed as Pemetrexed Sandoz is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Slovenian: Ker je zdravilo Pemetrexed Sandoz generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Alimta, niso bile potrebne nobene dodatne študije.
English: How does Pemetrexed Sandoz work?
Slovenian: Kako zdravilo Pemetrexed Sandoz deluje?
English: Date of last renewal: 16/04/2018
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 16/04/2018
English: ATCvet code: QI05AA10.
Slovenian: Oznaka ATC vet: QI05AA10
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Slovenian: Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove proizvajanje,uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovijo, da:
English: 1 Antigenic units determined by ELISA.
Slovenian: Antigenske enote določene z ELISA testom.
English: Any person intending to manufacture, import, possess, sell, supply and use Equilis West Nile must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: Vsakdo, ki nameravaproizvajati,uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo, se mora najprej posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti lahko prepovedane v državu članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: This swelling normally resolves within 1 to 5 days.
Slovenian: Ta oteklina navadno izgine v 1 do 5 dneh.
English: 42 micrograms
Slovenian: 42 mikrogramov
English: Opalescent suspension.
Slovenian: Opalescentna suspenzija.
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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v pdročje uporabeUredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: In laboratory studies and field trials:
Slovenian: NEŽELENI U ČINKI V laboratorijskih študijah in terenskih študijah:
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 tega cepiva, kadar se uporablja s kakšnim drugim zdravilom za uporabo v veterinarski medicini.
English: Primary vaccination: first injection from 6 months of age onwards, second injection 3 to 5 weeks later.
Slovenian: Osnovno cepljenje: prva injekcija od 6 mesecev starosti dalje, druga injekcija 3 do 5 tednov pozneje.
English: The vaccine stimulates active immunity against West Nile virus in horses.
Slovenian: Cepivo stimulira aktivno imunost proti virusu Zahodnega Nila pri konjih.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Slovenian: Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 2 leta
English: A mild body temperature increase (max. 1.5 °C) may very commonly occur for 1 to 2 days.
Slovenian: Telesna temperatura se lahko zelo pogosto rahlo poviša (največ za 1,5 °C) za 1 do 2 dni.
English: Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines.
Slovenian: Farmakoterapevtska skupina: imunološka zdravila za enoprste kopitarje (Equidae), inaktivirana virusna cepiva
English: Active immunisation of horses against West Nile virus (WNV) to reduce clinical signs of disease and lesions in the brain and to reduce viraemia.
Slovenian: Aktivna imunizacija konj proti virusu Zahodnega Nila (WNV) za zmanjšanje kliničnih znakov bolezni in poškodb v možganih in za zmanjšanje viremije.
English: Revaccination: a yearly booster injection of one dose (1 ml) should be sufficient to achieve a reduction of fever, lesions in the brain and viraemia.
Slovenian: Revakcinacija: Letna revakcinacija z enim odmerkom (1 ml) naj bi zadostovala, da se doseže zmanjšanje vročine, poškodb v možganih in viremije.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/06/2013.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 06/06/2013
English: - common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: - pogosti (pri več kot 1 toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1 toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1 toda manj kot 10 živalih od 10.000 zdravljenih živali)
English: EU/2/13/151/002 (5 pre-filled syringes) EU/2/13/151/003 (10 pre-filled syringes)
Slovenian: EU/2/13/151/001 (10 vial) EU/2/13/151/002 (5 napolnjenih injekcijskih brizg) EU/2/13/151/003 (10 napolnjenih injekcijskih brizg)
English: Inactivated chimeric flavivirus strain YF-WN
Slovenian: Inaktiviran himerični sev flavivirusa YF-WN
English: After vaccination a mild transient swelling may very commonly develop at the injection site (max. 3 cm in diameter).
Slovenian: Po cepljenju se lahko zelo pogosto pojavi rahla prehodna oteklina na mestu vboda (z največ 3 cm premera).
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Slovenian: Zato se za uporabo tega cepiva pred uporabo katerega koli drugega zdravila ali po njej odločamo od primera od primera.
English: 250 micrograms
Slovenian: 250 mikrogramov holesterol
English: 4.6 Adverse reactions (frequency and seriousness)
Slovenian: 4.6 Neželeni učinki (pogostost in resnost) V laboratorijskih študijah in terenskih študijah:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis West Nile [a clear pictogram of a horse]
Slovenian: Equilis West Nile [piktogram konja]
English: Adjuvant:
Slovenian: Dodatki:
English: TARGET SPECIES Horses
Slovenian: CILJNE ŽIVALSKE VRSTE
English: 6.5 Nature and composition of immediate packaging
Slovenian: 6.5 Vrsta in sestava stične ovojnine
English: Antigenic units Opalescent suspension.
Slovenian: Antigenske enote Opalescentna suspenzija
English: PACKAGE SIZE 10 vials x 1 dose 5 pre-filled syringes x 1 dose 10 pre-filled syringes x 1 dose
Slovenian: 5 napolnjenih injekcijskih brizg x 1 odmerek 10 napolnjenih injekcijskih brizg x 1 odmerek
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Slovenian: DATUM REVIZIJE BESEDILA
English: Type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Slovenian: Viale po 1 ml iz stekla tipa I (1 odmerek), zaprte z zamaškom iz halogenobutilne gume in zatesnjene z aluminijasto zaporko.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC(PROIZVAJALCI) BIOLOŠKE(BIOLOŠKIH) UČINKOVINE(UČINKOVIN) IN PROIZVAJALEC(PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: PACKAGE LEAFLET: Equilis West Nile suspension for injection for horses
Slovenian: Equilis West Nile suspenzija za injiciranje za konje
English: Disodium hydrogen phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid kalijev klorid dinatrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
English: Cardboard box or plastic box with 10 vials of 1 ml, or 5 or 10 pre-filled syringes of 1 ml
Slovenian: Kartonska škatla ali plastična škatla z 10 vialami po 1 ml ali s 5 ali 10 napolnjenimi brizgami po 1 ml
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Slovenian: Wim de Körverstraat 35 5831 AN Boxmeer
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/151/001-003
Slovenian: EU/2/13/151/001-003
English: Type I glass pre-filled syringes of 1ml (1 dose), containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Slovenian: Napolnjena injekcijska brizga po 1 ml iz stekla tipa I (1 odmerek), v kateri je bat z nastavkom iz halogenobutila, zaprta z zamaškom iz halogenobutilne gume.
English: Onset of immunity: 2 weeks after primary vaccination course of two injections.
Slovenian: Nastop imunosti: 2 tedna po osnovnem cepljenju (2 injekciji) Trajanje imunosti: 12 mesecev
English: Iscom-Matrix containing: Purified saponin
Slovenian: Iscom-Matrix, ki vsebuje:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis West Nile suspension for injection for horses
Slovenian: NAVODILO ZA UPORABO Equilis West Nile suspenzija za injiciranje za konje
English: Vaccination schedule: Administer one dose (1 ml) by intramuscular injection, according to the following schedule:
Slovenian: En odmerek (1 ml) intramuskularno po naslednji shemi: