FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended to clean and dry the external ear canal before the first administration of the product.
Slovenian: Priporoča se, da pred prvim dajanjem zdravila sluhovod očistite in osušite.
English: Lecithin
Slovenian: RAZLIČNA
English: After application, the base of the ear may be massaged briefly and gently to facilitate even distribution of the veterinary medicinal product into the ear canal.
Slovenian: Po vnosu lahko nekaj časa nežno masirate koren ušesa, da se zdravilo enakomerno porazdeli po vsem sluhovodu.
English: PHARMACOLOGICAL PROPERTIES
Slovenian: FARMACEVTSKI PODATKI
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 10 mg terbinafine, 10 mg florfenicol, 1 mg betamethasone acetate
Slovenian: 10 mg terbinafina, 10 mg florfenikola, 1 mg betametazonacetata
English: Off-white to slightly yellow translucent gel.
Slovenian: Belkast do rahlo rumen prosojen gel.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT OSURNIA ear gel for dogs terbinafine, florfenicol, betamethasone acetate (EN or Latin)
Slovenian: Terbinafinum, florfenicolum, betamethasoni acetas (Latin)
English: Ask your veterinary surgeon, pharmacist how to dispose of medicines no longer required.
Slovenian: Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem ali farmacevtom.
English: Florfenicol:
Slovenian: 10 mg florfenikol:
English: Oleic acid
Slovenian: OVOJNINAH Tuba
English: ROUTE(S) OF ADMINISTRATION Auricular use
Slovenian: POT(I) UPORABE ZDRAVILA Avrikularna uporaba.
English: Propylene carbonate Glycerol formal
Slovenian: 6.1 Seznam pomožnih snovi butilhidroksitoluen (E321) hipromeloza lecitin oleinska kislina propilen karbonat glicerol formal
English: This observation is attributed to presence of product and is not of clinical concern.
Slovenian: Na notranjem in zunanjem delu uhlja se lahko pojavi prehodna mokrota, ki je posledica prisotnosti zdravila, ni pa klinično pomembna.
English: EU/1/14/987/001 Holoclar cells/cm²
Slovenian: EU/1/14/987/001 Holoclar celic/cm2
English: 1 implant
Slovenian: 1 implantat
English: Living tissue equivalent
Slovenian: Ekvivalent živega tkiva
English: Implantation
Slovenian: Implantiranje
English: Screw cap container (stainless steel)
Slovenian: Vsebnik z navojnim zamaškom (nerjavno jeklo)
English: If symptoms persist, a doctor should be consulted.
Slovenian: Če simptomi ne izzvenijo, se je treba posvetovati z zdravnikom.
English: Walnut leaf EMA/HMPC/432131/2013
Slovenian: List navadnega oreha EMA/HMPC/432131/2013
English: In its assessment the HMPC considered the potential effects of juglone (a toxic component of walnut tree) but noted that it is only present in traces (very small amounts) in dry walnut leaf and therefore does not pose a risk to human health.
Slovenian: Pri svoji oceni je odbor HMPC upošteval možne učinke juglona (strupene sestavine orehovega drevesa), vendar je opozoril, da je ta v suhem listu navadnega oreha prisoten le v sledeh (v zelo majhnih količinah) in tako ne predstavlja tveganja za zdravje ljudi.
English: In its assessment the HMPC took into account the well documented and very longstanding use of walnut leaf for these indications.
Slovenian: Pri svoji oceni je odbor HMPC upošteval dobro dokumentirano in zelo dolgotrajno uporabo lista navadnega oreha za te indikacije.
English: Walnut leaf is the common name for the whole leaf of the tree Juglans regia L. The leaf is gathered from wild or cultivated trees.
Slovenian: List navadnega oreha je slovensko ime za celi list drevesa Juglans regia L. List se pridobiva z divjih ali gojenih dreves.
English: Walnut leaf medicines must not be applied on open wounds and large skin injuries.
Slovenian: Zdravila iz lista navadnega oreha se ne smejo nanašati na odprte rane in večje poškodbe kože.
English: The HMPC conclusions on the use of walnut leaf medicines for minor inflammatory skin conditions and excessive sweating are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC o uporabi zdravil iz lista navadnega oreha za blažja kožna vnetja in čezmerno znojenje temeljijo na njihovi „tradicionalni uporabi“.
English: This summary is not intended to provide practical advice on how to use medicines containing walnut leaf.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo list navadnega oreha.
English: Walnut leaf preparations should only be used in adults, and should not be used for longer than one week.
Slovenian: Pripravke iz lista navadnega oreha lahko uporabljajo le odrasli, in sicer največ en teden.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of walnut leaf.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo lista navadnega oreha.
English: The HMPC concluded that, on the basis of its long-standing use, walnut leaf can be used for the relief of minor inflammatory conditions of the skin and to reduce excessive sweating of the hands and feet.
Slovenian: Odbor HMPC je zaključil, da se list navadnega oreha glede na njegovo dolgotrajno uporabo lahko uporablja za lajšanje blažjih kožnih vnetij ter blaženje čezmernega znojenja dlani in stopal.
English: The HMPC also noted studies in laboratory tests, which showed that walnut leaf has antimicrobial effects.
Slovenian: Odbor HMPC je prav tako proučil študije z laboratorijskimi preiskavami, ki so pokazale, da ima list navadnega oreha protimikrobne učinke.
English: Further information on the risks associated with walnut leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo list navadnega oreha, vključno z ustreznimi previdnostmi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Detailed instruction on how to use walnut leaf medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila glede tega, kako se uporabljajo zdravila iz lista navadnega oreha in kdo jih lahko uporablja, najdete v navodilu za uporabo, ki je priloženo zdravilu.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing walnut leaf.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo list navadnega oreha.
English: Any applications for the licensing of medicines containing walnut leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo list navadnega oreha, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: EMA/HMPC/432131/2013
Slovenian: EMA/HMPC/432131/2013 Odbor za zdravila rastlinskega izvora (HMPC)
English: Further information on the HMPC assessment of walnut leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo list navadnega oreha, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Information on the use and licensing of walnut leaf medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo list navadnega oreha, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: How are walnut leaf medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo list navadnega oreha, odobrena v EU?
English: What evidence supports the use of walnut leaf medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo list navadnega oreha?
English: Herbal medicines containing walnut leaf are usually available as comminuted herbal material to be boiled in water to make a ‘decoction' which is applied to the skin.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo list navadnega oreha, so običajno na voljo v obliki zdrobljenega rastlinskega materiala, ki ga je treba prevreti v vodi, ta prevretek pa nato nanesti na kožo.
English: For practical information about using walnut leaf medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: Other information about walnut leaf medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo list navadnega oreha
English: For more information about treatment with walnut leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo list navadnega oreha, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with walnut leaf medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo list navadnega oreha?
English: Walnut leaf can also be found in combination with other herbal substances in some herbal medicines.
Slovenian: V nekaterih zdravilih rastlinskega izvora se list navadnega oreha uporablja tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: What is walnut leaf?
Slovenian: Kaj je list navadnega oreha?
English: Walnut leaf
Slovenian: List navadnega oreha
English: Walnut leaf preparations are obtained by comminuting (reducing into tiny pieces) the dried leaves.
Slovenian: Pripravki iz lista navadnega oreha se izdelujejo z drobljenjem posušenih listov.
English: ATCvet code: QI09AA03.
Slovenian: Oznaka ATC vet: QI09AA03.
English: Carbomer 971P NF
Slovenian: Karbomer 971P NF
English: Store in a refrigerator (2 ºC−8 ºC).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C).
English: 7 days after primary vaccination.
Slovenian: 7 dni po osnovnem cepljenju.
English: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau GERMANY
Slovenian: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau
English: 0.1 mg For the full list of excipients, see section 6.1.
Slovenian: 0,1 mg Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: The efficacy of revaccination has not been investigated and therefore no revaccination schedule is proposed.
Slovenian: Učinkovitost ponovnega cepljenja ni bila raziskana, zato shema ponovnega cepljenja ni podana.
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: Učinkovina, ki je v osnovi biološkega izvora in namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe (ES) št. 470/2009.
English: Date of first authorisation: 17/05/2017
Slovenian: Datum pridobitve dovoljenja za promet: 17/05/2017
English: Sodium chloride solution (0.9%)
Slovenian: Raztopina natrijevega klorida (0,9-odstotna)
English: EXP {month/year} Once opened, use within 10 hours.
Slovenian: EXP {mesec/leto} Odprto zdravilo porabite v 10 urah.
English: Keep the vial in the outer carton in order to protect from light.
Slovenian: Vialo shranjujte v zunanji ovojnini, da se zaščiti pred svetlobo.
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 veterinary medicinal product.
Slovenian: SPC, so bodisi dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki in škatli po EXP.
English: In such cases the piglets should be vaccinated after the age of 12 weeks.
Slovenian: V takih primerih je treba pujske cepiti po 12. tednu starosti.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - 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: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živalih od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: Pharmacotherapeutic group: Immunologicals, inactivated viral vaccines for pigs, porcine influenza virus.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila, inaktivirana virusna cepiva za prašiče, virus prašičje influence.
English: Vaccination: 2 injections of one dose (1 ml) from the age of 56 days, with an interval of 3 weeks between injections.
Slovenian: Cepljenje: Dve injiciranji po en odmerek (1 ml) od starosti 56 dni naprej, med katerima morajo preteči 3 tedni.
English: 1 HU - haemagglutinating units.
Slovenian: 1 HU - hemaglutinirajoče enote.
English: EU/2/17/209/001 (25 doses) EU/2/17/209/002 (50 doses)
Slovenian: EU/2/17/209/001 (25 odmerkov) EU/2/17/209/002 (50 odmerkov)
English: PET vials:
Slovenian: Viala iz PET:
English: In cases of exposure of the sows to antigens (from either field infections and/or vaccination) the antibodies transmitted to the piglets can interfere with active immunisation at 12 weeks of age.
Slovenian: Če so svinje izpostavljene antigenom (bodisi zaradi okužb na terenu in/ali cepljenja), lahko protitelesa, ki jih prenesejo na pujske, zavirajo aktivno imunizacijo do 12. tedna starosti.
English: Bromobutyl rubber stoppers
Slovenian: zamaški iz bromobutilne gume
English: A transient increase in rectal temperature, not exceeding 2 °C, is common after vaccination and this does not persist for more than one day.
Slovenian: Prehodno zvišanje rektalne temperature za največ 2 °C se pogosto pojavi po cepljenju in ne traja več kot en dan.
English: RESPIPORC FLUpan H1N1 suspension for injection for pigs
Slovenian: RESPIPORC FLUpan H1N1 suspenzija za injiciranje za prašiče
English: A transient swelling up to 2 cm3 may occur at the site of injection: these reactions are common but resolve within 5 days.
Slovenian: Prehodna oteklina velikosti največ 2 cm3 se lahko pojavi na mestu injiciranja: Take reakcije so pogoste vendar izginejo v petih dneh.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov proizvajalca biološke učinkovine:
English: It induces neutralising and haemagglutination-inhibiting antibodies against this subtype.
Slovenian: Cepivo povzroči tvorbo nevtralizirajočih in hemaglutinacijo zavirajočih protiteles proti tej podvrsti.
English: 25 ml (25 doses) 50 ml (50 doses)
Slovenian: 25 ml (25 odmerkov) 50 ml (50 odmerkov)
English: Clear to slightly turbid, reddish to pale-pink coloured suspension.
Slovenian: Bistra do rahlo motna, rdečkasto do bledo roza obarvana suspenzija.
English: Active immunisation of pigs from the age of 8weeks onwards against pandemic H1N1 porcine influenza virus to reduce viral lung load and virus excretion.
Slovenian: Aktivna imunizacija prašičev, starih 8 tednov ali več, proti pandemičnemu virusu prašičje influence H1N1 za zmanjšanje virusnega bremena v pljučih in izločanja virusa.
English: Aluminium flanged caps
Slovenian: aluminijaste prirobljene zaporke
English: The vaccine stimulates an active immunity against pandemic porcine influenza A/Jena/VI5258/2009 (H1N1)pandemic09-like virus.
Slovenian: Cepivo spodbuja aktivno imunost proti virusu, podobnemu pandemičnemu virusu prašičje influence A/Jena/VI5258/2009 (H1N1)pandemic09.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for 25 ml, 50 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonasta škatla za 25 ml, 50 ml
English: Haemagglutination-inhibiting antibodies have been detected in 15100% of the immunised pigs on day 7 after primary immunisation which disappeared in the majority of animals within 1 to 4 weeks thereafter.
Slovenian: Pri 15-100 % imuniziranih prašičev so 7. dan po osnovni imunizaciji opazili hemaglutinacijo zavirajoča protitelesa, ki so nato pri večini živali izginila v 1 do 4 tednih.
English: 4.2 Indication for use, specifying the target species
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah
English: PACKAGE LEAFLET FOR: RESPIPORC FLUpan H1N1 suspension for injection for pigs
Slovenian: NAVODILO ZA UPORABO RESPIPORC FLUpan H1N1 suspenzija za injiciranje za prašiče
English: FLUAV/Hamburg/NY1580/2009(H1N1)pdm09 (human origin), FLUAV/swine/Schallern/IDT19989/2014 (H1N1)pdm09 (swine origin) and FLUAV/sw/Teo(Spain)/AR641/2016 (H1N1)pdm09 (swine origin).
Slovenian: FLUAV/swine/Schallern/IDT19989/2014 (H1N1)pdm09 (prašičjega izvora) in FLUAV/sw/Teo(Spain)/AR641/2016 (H1N1)pdm09 (prašičjega izvora).
English: Neutralising antibodies in serum have been detected in more than 75% of the immunised pigs on day 7 after primary immunisation lasting in more than 75% of the pigs for over 3 months.
Slovenian: Pri več kot 75 % imuniziranih prašičev so 7. dan po osnovni imunizaciji opazili nevtralizirajoča protitelesa v serumu, ki so bila pri več kot 75 % prašičev prisotna več kot 3 mesece.
English: 25 ml polyethylene terephthalate (PET) vials 50 ml PET vials
Slovenian: 25-mililitrske viale iz polietilentereftalata (PET) 50-mililitrske viala iz PET
English: Duration of immunity: 3 months after primary vaccination.
Slovenian: 3 mesece po osnovnem cepljenju.
English: Cardboard box with 1 vial of 25 doses (25 ml) or 50 doses (50 ml) with a rubber stopper and flanged cap.
Slovenian: Kartonasta škatla z 1 vialo s 25 odmerki (25 ml) ali 50 odmerki (50 ml) z gumijastim zamaškom ter prirobljeno zaporko.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ
English: DATE OF FIRST AUTHORISATION
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
English: Cardboard box with 1 polyethylene terephthalate (PET) vial of 25 doses (25 ml) or 50 doses (50 ml) with a rubber stopper and flanged cap.
Slovenian: Kartonasta škatla z 1 vialo iz polietilentereftalata (PET) s 25 odmerki (25 ml) ali 50 odmerki (50 ml) z gumijastim zamaškom ter prirobljeno zaporko.
English: Name and address of the manufacturer responsible for batch release
Slovenian: NEMČIJA Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij
English: Generally, maternally-derived antibodies induced by vaccination last for approximately 5-8 weeks after birth.
Slovenian: 5-8 tednov po rojstvu.
English: Inactivated influenza A virus/human, strain A/Jena/VI5258/2009(H1N1)pdm09: ≥ 16 HU
Slovenian: Inaktivirani virus influence A (humani), sev A/Jena/VI5258/2009(H1N1)pdm09: ≥ 16 HU
English: Inactivated Influenza A virus/human Strain: A/Jena/VI5258/2009(H1N1)pdm09
Slovenian: Inaktivirani virus influence A (humani) Sev: A/Jena/VI5258/2009(H1N1)pdm09
English: Caps:
Slovenian: Zamaški:
English: Maternally-derived antibodies in piglets interfere with the RESPIPORC FLUpan H1N1 mediated immunity.
Slovenian: Maternalna protitelesa pri pujskih negativno vplivajo na imunost, izzvano s cepivom RESPIPORC
English: The antibody responses mentioned in the following have been documented in pigs without maternally-derived immunity.
Slovenian: Pri prašičih brez maternalne imunosti so zabeležili naslednje odzive protiteles.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Slovenian: ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: Stoppers:
Slovenian: Zaporke:
English: MARKETING AUTHORISATION HOLDER
Slovenian: IMETNIK(I) DOVOLJENJA ZA PROMET
English: A transient swelling up to 2 cm3 may occur at the site of injection, these reactions are common but resolve within 5 days.
Slovenian: Prehodna oteklina velikosti največ 2 cm3 se lahko pojavi na mestu injiciranja.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA
English: Inactivated influenza A virus/human Strain: A/Jena/VI5258/2009(H1N1)pdm09
Slovenian: A/Jena/VI5258/2009(H1N1)pdm09
English: Efficacy of the vaccine was examined in laboratory challenge studies in pigs without maternallyderived antibodies and was demonstrated against the following strains;
Slovenian: Učinkovitost cepiva je bila raziskana v laboratorijskih provokacijskih študijah pri prašičih brez maternalnih protiteles in je bila dokazana proti naslednjim sevom: FLUAV/Hamburg/NY1580/2009(H1N1)pdm09 (humanega izvora),
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lantus on 9 June 2000.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Lantus, veljavno po vsej Evropski uniji, odobrila dne 9. junija 2000.
English: Other information about Lantus:
Slovenian: Druge informacije o zdravilu Lantus:
English: The full EPAR for Lantus 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) za zdravilo Lantus je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Lantus is given once a day.
Slovenian: Zdravilo Lantus se daje enkrat na dan.
English: Patients can inject themselves with Lantus if they have been trained appropriately.
Slovenian: Bolniki si lahko zdravilo Lantus vbrizgajo sami, če so bili za to ustrezno usposobljeni.
English: EPAR summary for the public insulin glargine
Slovenian: Povzetek EPAR za javnost insulin glargin