FrancophonIA/ELRC3.0 huggingface dataset:
English: Cymbalta must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Slovenian: Zdravila Cymbalta pri bolnikih z obolenjem jeter, ki ima za posledico okvarjeno delovanje jeter, ne smemo uporabljati (glejte poglavji 4.3 in 5.2).
English: Cymbalta 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.
Slovenian: Cymbalta 30 mg je na voljo v pakiranju po 7, 28 in 98 trdih gastrorezistentnih kapsul.
English: The efficacy and safety of Cymbalta 30-120 mg once daily in elderly patients with generalised anxiety disorder was similar to that seen in studies of younger adult patients.
Slovenian: Cymbalta 30-120 mg enkrat na dan pri starejših bolnikih z generalizirano anksiozno motnjo sta bili podobni kot v študijah z mlajšimi odraslimi bolniki.
English: How to take Cymbalta
Slovenian: Kako jemati zdravilo Cymbalta
English: Cymbalta 30 mg Cymbalta 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.
Slovenian: Cymbalta 30 mg Cymbalta 30 mg je na voljo v pakiranju po 7, 28 in 98 trdih gastrorezistentnih kapsul.
English: Cymbalta 60 mg to 120 mg once daily demonstrated statistically significant superiority compared to placebo (p<0.001) on the prevention of relapse, as measured by time to relapse.
Slovenian: Zdravljenje z zdravilom Cymbalta 60 mg do 120 mg enkrat na dan se je izkazalo za statistično značilno boljše v primerjavi s placebom (p < 0,001) pri preprečevanju relapsa, kar so izmerili s časom do relapsa.
English: Cymbalta contains the active substance duloxetine.
Slovenian: Zdravilo Cymbalta vsebuje učinkovino duloksetin.
English: Excipient(s) with known effect Each capsule may contain up to 56 mg sucrose.
Slovenian: Ena kapsula lahko vsebuje do 56 mg saharoze.
English: Response and remission rates were also higher with Cymbalta compared to placebo.
Slovenian: Ob uporabi zdravila Cymbalta v primerjavi s placebom so bile višje tudi stopnje odziva in remisije.
English: The efficacy of Cymbalta at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Slovenian: Učinkovitost zdravila Cymbalta v priporočenem odmerku 60 mg enkrat na dan so pokazali v treh od treh randomiziranih dvojno slepih s placebom kontroliranih akutnih preskušanjih z določenim odmerkom pri odraslih bolnikih z veliko depresivno motnjo, zdravljenih ambulantno.
English: EU/1/04/296/007 (500 hard gastro-resistant capsules) (25 packs of 20) EU/1/04/296/008 (100 hard gastro-resistant capsules) (5 packs of 20)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/296/007 (500 trdih gastrorezistentnih kapsul) (25 pakiranj po 20) EU/1/04/296/008 (100 trdih gastrorezistentnih kapsul) (5 pakiranj po 20)
English: The use of Cymbalta while breastfeeding is not recommended.
Slovenian: Uporabo zdravila Cymbalta v času dojenja odsvetujemo.
English: Also, you need to wait at least 5 days after you stop taking Cymbalta before you take a MAOI.
Slovenian: Tudi po prenehanju jemanja zdravila Cymbalta morate počakati vsaj 5 dni, preden lahko vzamete MAOI.
English: Multipack: 500 (25 packs of 20) hard gastro-resistant capsules Multipack: 100 (5 packs of 20) hard gastro-resistant capsules
Slovenian: Večje pakiranje: 100 (5 pakiranj po 20) trdih gastrorezistentnih kapsul
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of Cymbalta 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Slovenian: 8-tedensko akutno zdravljenje z zdravilom Cymbalta 60 mg enkrat na dan, ohranilo nadaljnjih 6 mesecev (merjeno s spremembo postavke 24-urne povprečne bolečine vprašalnika BPI (Brief Pain Inventory).
English: The effect of Cymbalta 60 mg once a day in elderly depressed patients (≥65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17 score for duloxetine-treated patients compared to placebo.
Slovenian: Pri starejših depresivnih bolnikih (≥ 65 let) so posebej preučevali učinek zdravila Cymbalta 60 mg enkrat na dan v študiji, ki je pokazala statistično pomembno razliko v zmanjšanju HAMD17 rezultata za bolnike, ki so bili zdravljeni z duloksetinom, v primerjavi s tistimi, ki so prejemali placebo.
English: The incidence of relapse during the 6-months double-blind follow-up period was 17% and 29% for duloxetine and placebo, respectively.
Slovenian: Incidenca relapsa v 6-mesečnem obdobju dvojno slepega sledenja je bila 17 % oziroma 29 %
English: Monoamine oxidase inhibitors (MAOIs): You should not take Cymbalta if you are taking, or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
Slovenian: Svojemu zdravniku povejte tudi, če jemljete karkoli od naslednjega: Zaviralci monoaminooksidaze (MAOI): Zdravila Cymbalta ne smete jemati, če jemljete ali ste v zadnjih 14 dneh vzeli drugo antidepresivno zdravilo, imenovano zaviralec monoaminooksidaze
English: Cymbalta with food, drink and alcohol
Slovenian: Zdravilo Cymbalta skupaj s hrano, pijačo in z alkoholom Zdravilo Cymbalta lahko vzamete s hrano ali brez nje.
English: Cymbalta 30 mg Each capsule contains 30 mg of duloxetine (as hydrochloride).
Slovenian: Cymbalta 30 mg Ena kapsula vsebuje 30 mg duloksetina (v obliki klorida).
English: 9 Estimated frequency based on all clinical trial data.
Slovenian: 9 Ocenjena pogostnost temelji na vseh podatkih kliničnih preskušanj.10Ocenjena pogostnost na podlagi kliničnih preskušanj, nadzorovanih s placebom c. Opis izbranih neželenih učinkov
English: Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Cymbalta before starting an MAOI (see section 4.3).
Slovenian: Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila Cymbalta preteči vsaj 5 dni pred začetkom jemanja MAOI
English: Talk to your doctor before you take Cymbalta if you: - are taking other medicines to treat depression (see ‘Other medicines and Cymbalta') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and Cymbalta')
Slovenian: - ste v preteklosti imeli motnje strjevanja krvi (nagnjenost k razvoju podplutb), sploh če ste noseči (glejte ‘Nosečnost in dojenje‘) - imate tveganje za nizek nivo natrija (če na primer jemljete diuretike, sploh če ste starejši) - se trenutno zdravite z drugimi zdravili, ki lahko povzročijo poškodbo jeter
English: Photo-sensitivity reactions Increased tendency to bruise Musculoskeletal and connective tissue disorders Musculo-skeletal pain Muscle spasm
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišično-skeletna bolečina mišični krč napetost mišic trzanje mišic trizem
English: EU/1/04/296/002 (28 hard gastro-resistant capsules) EU/1/04/296/003 (84 hard gastro-resistant capsules) EU/1/04/296/004 (98 hard gastro-resistant capsules) EU/1/04/296/005 (56 hard gastro-resistant capsules)
Slovenian: EU/1/04/296/002 (28 trdih gastrorezistentnih kapsul) EU/1/04/296/003 (84 trdih gastrorezistentnih kapsul) EU/1/04/296/004 (98 trdih gastrorezistentnih kapsul) EU/1/04/296/005 (56 trdih gastrorezistentnih kapsul)
English: The concomitant use of Cymbalta with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Slovenian: Sočasno uporabo zdravila Cymbalta s selektivnimi reverzibilnimi MAOI, kakršen je npr. moklobemid, odsvetujemo (glejte poglavje 4.4).
English: Cymbalta demonstrated statistically significant superiority over placebo as measured by improvement in the Hamilton Anxiety Scale (HAM-A) total score and by the Sheehan Disability Scale (SDS) global functional impairment score.
Slovenian: Cymbalta se je izkazala za statistično značilno boljšo kot placebo, kar so izmerili z izboljšanjem skupnega števila točk po Hamiltonovi lestvici za ocenjevanje anksioznosti (Hamilton Anxiety Scale,
English: In studies of up to 9 months an overall mean decrease of 1% in height percentile (decrease of 2% in children (7-11 years) and increase of 0.3% in adolescents (12-17 years)) was observed in duloxetinetreated paediatric patients (see section 4.4).
Slovenian: V študijah, ki so trajale do 9 mesecev, so pri pediatričnih bolnikih, zdravljenih z duloksetinom, opazili skupno povprečno zmanjšanje za 1 % višinskega percentila (zmanjšanje za 2 % pri otrocih (7-11 let)
English: In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label Cymbalta 60 mg once daily were randomised to either Cymbalta 60 mg once daily or placebo for a further 6-months.
Slovenian: V študiji preprečevanja relapsa so bolnike, ki so se odzvali na 12-tedensko akutno zdravljenje z znanim zdravilom Cymbalta 60 mg enkrat na dan, naključno razporedili v skupini, kjer so nadaljnjih 6
English: Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
Slovenian: denimo, benzodiazepini, močna zdravila proti bolečinam, antipsihotiki, fenobarbital in antihistaminiki.
English: Concomitant use of Cymbalta with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Slovenian: Zdravila Cymbalta ne smemo uporabljati sočasno z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4.5).
English: How to store Cymbalta
Slovenian: Shranjevanje zdravila Cymbalta
English: Cymbalta 30 mg hard gastro-resistant capsules Cymbalta 60 mg hard gastro-resistant capsules
Slovenian: Cymbalta 30 mg trde gastrorezistentne kapsule Cymbalta 60 mg trde gastrorezistentne kapsule
English: 10Estimated frequency based on placebo-controlled clinical trials.
Slovenian: dvojno slepo, s placebom kontrolirano študijo.
English: EU/1/04/296/001 (28 hard gastro-resistant capsules) EU/1/04/296/006 (7 hard gastro-resistant capsules) EU/1/04/296/009 (98 hard gastro-resistant capsules)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/296/001 (28 trdih gastrorezistentnih kapsul) EU/1/04/296/006 (7 trdih gastrorezistentnih kapsul) EU/1/04/296/009 (98 trdih gastrorezistentnih kapsul)
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Slovenian: Cymbalta 60 mg želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132) rumeni železov oksid (E172) užitno belo črnilo
English: Cymbalta 30 mg Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Slovenian: Neprozorno belo telo z vtisnjenim napisom ‘30 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9543'.
English: Cymbalta 60 mg Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Slovenian: Neprozorno zeleno telo z vtisnjenim napisom ‘60 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9542'.
English: Cymbalta 60 mg hard gastro-resistant capsules Duloxetine
Slovenian: Cymbalta 60 mg trde gastrorezistentne kapsule duloksetin
English: Adverse reactions may be more common during concomitant use of Cymbalta and herbal preparations containing St John's wort (Hypericum perforatum).
Slovenian: Ob sočasni uporabi zdravila Cymbalta in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
English: Cymbalta contains sucrose.
Slovenian: Zdravilo Cymbalta vsebuje saharozo.
English: Cymbalta 30 mg hard gastro-resistant capsules Duloxetine
Slovenian: Cymbalta 30 mg trde gastrorezistentne kapsule duloksetin
English: 28 hard gastro-resistant capsules 7 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 28 trdih gastrorezistentnih kapsul 7 trdih gastrorezistentnih kapsul 98 trdih gastrorezistentnih kapsul
English: Medicinal product subject to medical prescription
Slovenian: Zdravljenje z zdravilom
English: Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Slovenian: Motnje reprodukcije in dojk erektilna disfunkcija motnje ejakulacije ginekološka krvavitev motnje menstruacije menopavzalni simptomi galaktoreja hiperprolakti zapoznelaejakulacija spolna disfunkcija bolečina v testisih nemija poporodna krvavitev6
English: Call your doctor or pharmacist immediately if you take more than the amount of Cymbalta prescribed by your doctor.
Slovenian: Če vzamete večjo količino zdravila Cymbalta, kot vam je predpisal vaš zdravnik, nemudoma pokličite svojega zdravnika ali farmacevta.
English: Cymbalta is a hard gastro-resistant capsule.
Slovenian: Izgled zdravila Cymbalta in vsebina pakiranja Cymbalta je trda gastrorezistentna kapsula.
English: Cymbalta is for oral use.
Slovenian: Zdravilo Cymbalta jemljemo peroralno.
English: Cymbalta contains sucrose
Slovenian: Zdravilo Cymbalta vsebuje saharozo
English: Glaucoma
Slovenian: Cymbalta.
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink
Slovenian: Cymbalta 30 mg želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132)
English: Each capsule contains 60 mg of duloxetine (as hydrochloride)
Slovenian: Ena kapsula vsebuje 60 mg duloksetina (v obliki duloksetinijevega klorida).
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take Cymbalta.
Slovenian: Po prenehanju jemanja MAOI morate počakati vsaj 14 dni,
English: Renal and urinary disorders Dysuria
Slovenian: Infekcijske in parazitske bolezni laringitis
English: − are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Cymbalta')
Slovenian: - ste alergični (preobčutljivi) na duloksetin ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju 6) - imate obolenje jeter - imate hudo obolenje ledvic - jemljete ali ste v zadnjih 14 dneh jemali drugo antidepresivno zdravilo, imenovano zaviralec monoaminooksidaze (MAOI) (glejte »Druga zdravila in zdravilo Cymbalta«)
English: Contains sucrose See leaflet for further information
Slovenian: Shranjevanje zdravila Cymbalta Vsebina pakiranja in dodatne informacije
English: Caution is advised if Cymbalta is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Slovenian: (risperidon, triciklični antidepresivi [tricyclic antidepressants, TCAs], kot so nortriptilin, amitriptilin in imipramin) in zlasti če imajo ozek terapevtski indeks (kot na primer s flekainidom, propafenonom in metoprololom), svetujemo previdnost.
English: Overall, Cymbalta's efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Slovenian: 120 mg v skupaj petih od sedmih randomiziranih dvojno slepih s placebom kontroliranih akutnih preskušanjih z določenim odmerkom pri odraslih bolnikih z veliko depresivno motnjo, zdravljenih ambulantno.
English: Cymbalta 30 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Cymbalta 30 mg
English: Cymbalta 30 mg hard gastro-resistant capsules.
Slovenian: 30 mg trde gastrorezistentne kapsule
English: Cymbalta 60 mg hard gastro-resistant capsules.
Slovenian: 60 mg trde gastrorezistentne kapsule
English: Reproductive system and breast disorders Erectile dysfunction
Slovenian: Bolezni imunskega sistema anafilaktična reakcija preobčutljivost
English: Each capsule contains 30 mg of duloxetine (as hydrochloride)
Slovenian: Ena kapsula vsebuje 30 mg duloksetina v obliki duloksetinijevega klorida.
English: Duloxetine (as hydrochloride)
Slovenian: ob uporabi duloksetina oziroma placeba.
English: Sugar spheres
Slovenian: Likertove lestvice.
English: ATC vet code: QI09AB02.
Slovenian: Oznaka ATC vet: QI09AB02.
English: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Germany
Slovenian: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau
English: 4.4 Special warnings for each target species Vaccinate healthy animals only.
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto Cepite samo zdrave živali.
English: Water for injections Glutaraldehyde
Slovenian: Voda za injekcije Glutaraldehid
English: ≥ 3.2 x 106 ELISA units
Slovenian: ≥ 3,2 x 106 enot ELISA
English: Aluminium hydroxide (Al(OH)3) Thiomersal
Slovenian: Aluminijev hidroksid (Al(OH)3) Tiomersal
English: The preferred application site is the neck muscle behind the ear.
Slovenian: Najboljše mesto injiciranja je vratna mišica za ušesom.
English: Prior to administration, shake the vaccine carefully.
Slovenian: Pred uporabo cepivo previdno pretresite.
English: A single intramuscular injection (1 ml) to pigs from the age of 4 days.
Slovenian: Ena intramuskularna injekcija (1 ml) za prašičke, stare več kot 4 dni.
English: PACKAGE SIZE 100 doses
Slovenian: VELIKOST PAKIRANJA 100 odmerkov
English: Only vaccinate healthy animals.
Slovenian: Cepite le zdrave živali.
English: Commonly very small local reactions such as mild swelling at the injection site (maximum of 5 mm) may be observed, but these reactions are transient and subside within a short time (up to seven days) without treatment.
Slovenian: Pogosto so opazili majhne lokalne reakcije, kot je blaga oteklina na mestu injiciranja (največ 5 mm), vendar so te reakcije prehodne in čez kratek čas (do sedem dni) izzvenijo brez zdravljenja.
English: Pharmacotherapeutic group: Immunologicals for suidae, inactivated bacterial vaccines.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za prašiče, inaktivirana bakterijska cepiva.
English: Commonly a slight rise in body temperature (maximum of 1.7 °C) may occur after injection.
Slovenian: Pogosto se lahko po injiciranju cepiva pojavi rahel dvig telesne temperature (največ za 1,7 °C).
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: Pomožne snovi (vključno z dodatki), 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: It is recommended to use a needle appropriate for the age of the piglets (preferred size 21G length 16 mm).
Slovenian: Priporoča se uporaba igle, ustrezne za starost prašičkov (najboljša velikost je 21 G, dolžina 16 mm).
English: Genetically modified recombinant Stx2e antigen:
Slovenian: Gensko modificirani rekombinantni antigen Stx2e:
English: PET bottle containing 50 ml or 100 ml closed with a bromobutyl rubber stopper and sealed with an aluminium tear-off cap.
Slovenian: Plastenka PET, ki vsebuje 50 ml ali 100 ml, zaprta z zamaškom iz bromobutilne gume, zatesnjena z aluminijasto odtržno zaporko.
English: However, these reactions subside within a short time (maximum of two days) without treatment.
Slovenian: Vendar te reakcije čez kratek čas (največ dva dni) izzvenijo brez zdravljenja.
English: The vaccine consisting of genetically modified recombinant Stx2e stimulates an active immunity against Shiga toxin 2e produced by the causative agent of oedema disease in pigs.
Slovenian: Cepivo, sestavljeno iz gensko modificiranega rekombinantnega Stx2e, spodbuja aktivno imunost pred toksinom Shiga 2e, ki ga povzročajo povzročitelji edemske bolezni pri prašičih.
English: Following the administration of a double dose of vaccine no adverse reactions other than those described in section 4.6 have been observed.
Slovenian: Po uporabi dvojnega odmerka cepiva niso opazili drugih neželenih učinkov, kot tistih, opisanih v poglavju 4.6.
English: SPECIAL WARNINGS Special precautions for use in animals:
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih:
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label or carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini ali zunanji ovojnini.
English: Active immunisation of piglets from the age of 4 days, to reduce the mortality and clinical signs of oedema disease caused by Stx2e toxin produced by E. coli (STEC).
Slovenian: Aktivna imunizacija prašičkov od starosti 4 dni za zmanjšanje smrtnosti in kliničnih znakov edemske bolezni, ki jo povzroča toksin Stx2e, ki ga proizvaja bakterija E. coli (STEC).
English: Pregnancy and lactation:
Slovenian: Brejosti in laktacija:
English: MANUFACTURER'S BATCH NUMBER Lot: {number}
Slovenian: PROIZVAJALČEVA ŠTEVILKA SERIJE Lot: {številka}
English: Following the administration of a double dose of vaccine no adverse reactions other than those described in section 6 have been observed.
Slovenian: Po uporabi dvojnega odmerka cepiva niso opazili drugih neželenih učinkov, kot tistih, opisanih v poglavju 6.
English: 21 days after vaccination Duration of immunity: 105 days after vaccination
Slovenian: Nastop imunosti: 21 dni po cepljenju Trajanje imunosti: 105 dni po cepljenju
English: Excipient: Thiomersal max. 0.115 mg For the full list of excipients, see section 6.1.
Slovenian: 0,115 mg Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Appearance after shaking: yellowish to brownish, homogenous suspension.
Slovenian: Videz po stresanju: rumenkasto do rjavkasta, homogena suspenzija.
English: DATE OF REVISION OF THE TEXT
Slovenian: DATUM REVIZIJE BESEDILA {MM/LLLL}
English: Adjuvant: Aluminium (as hydroxide)
Slovenian: Aluminij (v obliki hidroksida) najv.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ecoporc SHIGA suspension for injection for pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ecoporc SHIGA suspenzija za injiciranje za prašiče
English: Between the withdrawals the vaccine should be stored at 2 °C - 8 °C.
Slovenian: Med izvleki cepivo shranjujte pri 2 °C - 8 °C.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/001 PET bottle of 50 ml EU/2/13/149/002 PET bottle of 100 ml
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/13/149/001 plastenko PET s 50 ml EU/2/13/149/002 plastenko PET s 100 ml
English: 21 days after vaccination
Slovenian: Nastop imunosti: 21 dni po cepljenju
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Slovenian: B POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
English: Excipient: Thiomersal max. 0.115 mg Appearance after shaking: yellowish to brownish, homogenous suspension.
Slovenian: 0,115 mg Videz po stresanju: rumenkasto do rjavkasta, homogena suspenzija
English: Do not use in cases of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Slovenian: Ne uporabite v primerih preobčutljivosti na učinkovino ali na katero koli pomožno snov.
English: Duration of immunity: 105 days after vaccination 4.3 Contraindications
Slovenian: Trajanje imunosti: 105 dni po cepljenju
English: PACKAGE SIZE 50 ml (50 doses) 100 ml (100 doses)
Slovenian: VELIKOST PAKIRANJA 50 ml (50 odmerkov) 100 ml (100 odmerkov)
English: Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Slovenian: KONTRAINDIKACIJE Ne uporabite v primerih preobčutljivosti na učinkovino, dodatek ali na katero koli pomožno snov.