FrancophonIA/ELRC3.0 huggingface dataset:
English: Cymbalta 60 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.004) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
Croatian: Cymbalta u dozi od 60 mg jednom dnevno bila je statistički značajno superiornija u usporedbi s placebom (p=0,004) s obzirom na primarnu mjeru ishoda - prevenciju relapsa depresije, mjereno vremenom do pojave relapsa.
English: Your doctor will tell you if you should be taking Cymbalta.
Croatian: Liječnik će Vam reći smijete li uzimati lijek Cymbalta.
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).
Croatian: Savjetuje se oprez ako se Cymbalta primjenjuje istodobno s lijekovima koji se metaboliziraju prvenstveno pomoću CYP2D6 (risperidon, triciklički antidepresivi poput nortriptilina, amitriptilina i imipramina), naročito ako imaju uzak terapijski indeks (poput flekainida, propafenona i metoprolola).
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.
Croatian: Djelotvornost i sigurnost lijeka Cymbalta u dozi od 30-120 mg jednom dnevno u starijih bolesnika s generaliziranim anksioznim poremećajem bile su slične onima primijećenima u ispitivanjima mlađih odraslih bolesnika.
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).
Croatian: Ne smijete uzimati lijek Cymbalta ako uzimate ili ste nedavno (u posljednjih 14 dana) uzimali drugi antidepresiv koji se naziva inhibitorom monoaminooksidaze (MAOI).
English: Cymbalta showed comparable efficacy results to venlafaxine in terms of improvements on the HAM-A total score.
Croatian: Rezultati djelotvornosti lijeka Cymbalta bili su usporedivi s rezultatima venlafaksina u smislu poboljšanja ukupnog rezultata na HAM-A ljestvici.
English: Paediatric population: Pharmacokinetics of duloxetine in paediatric patients aged 7 to 17 years with major depressive disorder following oral administration of 20 to 120 mg once daily dosing regimen was characterized using population modelling analyses based on data from 3 studies.
Croatian: Pedijatrijska populacija: Farmakokinetika duloksetina nakon peroralne primjene doze od 20-120 mg jedanput na dan u pedijatrijskih bolesnika u dobi od 7 do 17 godina s velikim depresivnim poremećajem okarakterizirana je uz pomoć analiza populacijskih modela na temelju podataka iz 3
English: Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
English: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Cymbalta to patients with increased intraocular pressure, or those at risk of acute narrowangle glaucoma.
Croatian: Prijavljeni su slučajevi midrijaze pri uzimanju duloksetina te se stoga Cymbalta mora s oprezom propisivati bolesnicima s povišenim očnim tlakom i onima s rizikom za pojavu akutnog glaukoma uskog kuta.
English: Cymbalta is used in adults to treat:
Croatian: Cymbalta se primjenjuje u odraslih za liječenje: • depresije
English: No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min).
Croatian: U bolesnika s blagim ili umjerenim poremećajem bubrežne funkcije (klirens kreatinina 30-80 ml/min)
English: Cymbalta hard gastro-resistant capsules contain sucrose.
Croatian: Cymbalta tvrde želučanootporne kapsule sadrže saharozu.
English: Response and remission rates were also higher with Cymbalta compared to placebo.
Croatian: Stopa odgovora na liječenje i stopa remisije bile su također više kod primjene lijeka Cymbalta u usporedbi s placebom.
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.
Croatian: Učinak lijeka Cymbalta u dozi od 60 mg jednom dnevno u starijih depresivnih bolesnika (≥ 65 godina) posebno je ispitivan u ispitivanju koje je pokazalo statistički značajnu razliku u smanjenju broja bodova na HAMD17 ljestvici u bolesnika liječenih duloksetinom u odnosu na one koji su uzimali placebo.
English: The efficacy of Cymbalta 30-120 mg (flexible dosing) once a day in elderly patients (>65 years) with generalised anxiety disorder was evaluated in a study that demonstrated statistically significant improvement in the HAM-A total score for duloxetine treated patients compared to placebo treated patients.
Croatian: Djelotvornost lijeka Cymbalta u dozi od 30-120 mg (fleksibilno doziranje) jednom dnevno u starijih bolesnika (> 65 godina) s generaliziranim anksioznim poremećajem ocijenjena je u ispitivanju koje je pokazalo statistički značajno poboljšanje ukupnog broja bodova na HAM-A ljestvici u bolesnika liječenih duloksetinom u odnosu na one koji su uzimali placebo.
English: Cymbalta 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.
Croatian: Cymbalta 30 mg dostupna je u pakiranjima od 7, 28 i 98 tvrdih želučanootpornih kapsula.
English: Cymbalta 30 mg Cymbalta 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.
Croatian: Cymbalta 30 mg Cymbalta 30 mg dostupna je u pakiranjima koja sadrže 7, 28 i 98 tvrdih želučanootpornih kapsula.
English: Consequently, caution is advised when Cymbalta is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Croatian: Stoga se preporučuje oprez kada se Cymbalta primjenjuje u kombinaciji s drugim lijekovima i tvarima koje djeluju na SŽS, uključujući alkohol i sedative (npr. benzodiazepine, morfinomimetike,
English: Response and remission rates were also statistically significantly higher with Cymbalta compared with placebo.
Croatian: Stope odgovora na liječenje i remisije bile su također statistički značajno veće pri uzimanju lijeka Cymbalta nego pri uzimanju placeba.
English: Concomitant use of Cymbalta with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Croatian: Kontraindicirana je istodobna primjena lijeka Cymbalta s neselektivnim, ireverzibilnim inhibitorima monoaminooksidaze (MAOI) (vidjeti dio 4.5).
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.
Croatian: Djelotvornost lijeka Cymbalta pri preporučenoj dozi od 60 mg jednom dnevno pokazana je u tri od tri randomizirana, dvostruko slijepa, placebom kontrolirana kratkoročna ispitivanja fiksnih doza u odraslih ambulantno liječenih bolesnika s velikim depresivnim poremećajem.
English: Cymbalta may be associated with sedation and dizziness.
Croatian: Uzimanje lijeka Cymbalta može biti povezano s pojavom sedacije i omaglice.
English: 28 hard gastro-resistant capsules 7 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Croatian: 28 tvrdih želučanootpornih kapsula 7 tvrdih želučanootpornih kapsula 98 tvrdih želučanootpornih kapsula
English: Excipient(s) with known effect Each capsule may contain up to 111 mg sucrose.
Croatian: Jedna kapsula može sadržavati do 111 mg saharoze.
English: Caution is advisable if Cymbalta is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Croatian: Preporučuje se oprez ako se Cymbalta primjenjuje istodobno sa serotoninergičkim lijekovima poput SSRI-ja, SNRI-ja, tricikličkih antidepresiva poput klomipramina i amitriptilina, inhibitora MAO poput moklobemida ili linezolida, gospine trave (Hypericum perforatum) ili triptana, tramadola, petidina i triptofana (vidjeti dio 4.4).
English: Major Depressive Disorder: Cymbalta was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Croatian: 3158 bolesnika (1285 bolesnik-godina izloženosti) koji su zadovoljavali DSM-IV kriterije za veliki depresivni poremećaj.
English: How to take Cymbalta
Croatian: Kako uzimati lijek Cymbalta
English: The use of Cymbalta while breastfeeding is not recommended.
Croatian: Ne preporučuje se uzimanje lijeka Cymbalta za vrijeme dojenja.
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.
Croatian: Sveukupno je djelotvornost lijeka Cymbalta u dnevnim dozama od 60 do 120 mg pokazana u ukupno pet od sedam randomiziranih, dvostruko slijepih, placebom kontroliranih kratkoročnih ispitivanja fiksnih doza u odraslih ambulantno liječenih bolesnika s velikim depresivnim poremećajem.
English: Also, you need to wait at least 5 days after you stop taking Cymbalta before you take a MAOI.
Croatian: Također, nakon što ste prestali uzimati lijek Cymbalta, morate pričekati najmanje 5 dana prije nego počnete uzimati inhibitor MAO.
English: Photo-sensitivity reactions Increased tendency to bruise Musculoskeletal and connective tissue disorders Musculo-skeletal pain Muscle spasm
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićno-koštana bol spazam mišića stezanje mišića trzanje mišića trizmus
English: Cymbalta contains sucrose.
Croatian: Cymbalta sadrži saharozu.
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)
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/296/007 (500 tvrdih želučanootpornih kapsula) (25 kutija s 20) EU/1/04/296/008 (100 tvrdih želučanootpornih kapsula) (5 kutija s 20)
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.
Croatian: U ispitivanju prevencije relapsa, bolesnici koji su reagirali na otvoreno akutno liječenje lijekom Cymbalta u dozi od 60 mg jednom dnevno u trajanju od 12 tjedana randomizirani su ili u skupinu koja je sljedećih 6 mjeseci uzimala lijek Cymbalta u dozi od 60 mg jednom dnevno ili u skupinu koja je uzimala placebo.
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take Cymbalta.
Croatian: Nakon što ste prestali uzimati inhibitor MAO, morate pričekati najmanje 14 dana prije nego počnete uzimati lijek Cymbalta.
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')
Croatian: - ako patite od bipolarnog poremećaja - ako imate tegobe s očima poput određenih vrsta glaukoma (povišen očni tlak) - ako u povijesti bolesti imate poremećaje krvarenja (sklonost pojavi modrica), osobito ako ste trudni (pogledajte dio „Trudnoća i dojenje“) - imate rizik od pojave niske razine natrija (primjerice, ako uzimate diuretike, osobito ako ste starija osoba)
English: Data on the use of Cymbalta 120 mg in elderly patients with major depressive disorder and generalised anxiety disorder are limited.
Croatian: Starije osobe Postoje samo ograničeni podaci o primjeni lijeka Cymbalta u dozi od 120 mg u starijih osoba s velikim depresivnim poremećajem i generaliziranim anksioznim poremećajem.
English: Cymbalta contains sucrose
Croatian: Cymbalta sadrži saharozu
English: Excipient(s) with known effect Each capsule may contain up to 56 mg sucrose.
Croatian: Jedna kapsula može sadržavati do 56 mg saharoze.
English: Cymbalta demonstrated statistical superiority over placebo as measured by improvement in the 17item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
Croatian: Hamilton Depression Rating Scale, HAM-D) zasnovanom na 17 pokazatelja (uključujući emocionalne i somatske simptome depresije).
English: Taking a MAOI together with many prescription medicines, including Cymbalta, can cause serious or even life-threatening side effects.
Croatian: uključujući lijek Cymbalta, može izazvati ozbiljne, čak i po život opasne nuspojave.
English: Adverse reactions may be more common during concomitant use of Cymbalta and herbal preparations containing St John's wort (Hypericum perforatum).
Croatian: Pri istodobnom uzimanju lijeka Cymbalta i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
English: How to store Cymbalta
Croatian: Kako čuvati lijek Cymbalta
English: What you need to know before you take Cymbalta DO NOT take Cymbalta if you:
Croatian: Što morate znati prije nego počnete uzimati lijek Cymbalta
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)
Croatian: EU/1/04/296/001 (28 tvrdih želučanootpornih kapsula) EU/1/04/296/006 (7 tvrdih želučanootpornih kapsula) EU/1/04/296/009 (98 tvrdih želučanootpornih kapsula)
English: The majority of cases of hyponatraemia were reported in the elderly, especially when coupled with a recent history of, or condition pre-disposing to, altered fluid balance.
Croatian: posebno kada je udružena s nedavnom anamnezom promjene ravnoteže tekućina ili s predisponirajućim stanjima za razvoj takvog poremećaja.
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)
Croatian: EU/1/04/296/002 (28 tvrdih želučanootpornih kapsula) EU/1/04/296/003 (84 tvrde želučanootporne kapsule) EU/1/04/296/004 (98 tvrdih želučanootpornih kapsula) EU/1/04/296/005 (56 tvrdih želučanootpornih kapsula)
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.
Croatian: 8-tjedno akutno liječenje lijekom Cymbalta u dozi od 60 mg jednom dnevno održalo se tijekom sljedećih 6 mjeseci, mjereno promjenom 24-satnih podataka o prosječnoj boli u kratkom upitniku o boli (eng.
English: Cymbalta 30 mg Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Croatian: Neprozirno tijelo bijele boje s otisnutom oznakom „30 mg“' i neprozirna plava kapica s otisnutom oznakom „9543“'.
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with Cymbalta (see section 4.4).
Croatian: inhibitor i ne smije se davati bolesnicima koji se liječe lijekom Cymbalta (vidjeti dio 4.4).
English: Cymbalta 30 mg hard gastro-resistant capsules Cymbalta 60 mg hard gastro-resistant capsules
Croatian: Cymbalta 30 mg tvrde želučanootporne kapsule Cymbalta 60 mg tvrde želučanootporne kapsule
English: Cymbalta 60 mg Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Croatian: Neprozirno tijelo zelene boje s otisnutom oznakom „60 mg“ i neprozirna plava kapica s otisnutom oznakom „9542“.
English: What Cymbalta is and what it is used for What you need to know before you take Cymbalta How to take Cymbalta
Croatian: Što je Cymbalta i za što se koristi Cymbalta sadrži djelatnu tvar duloksetin.
English: Cymbalta 60 mg hard gastro-resistant capsules Duloxetine
Croatian: Cymbalta 60 mg tvrde želučanootporne kapsule duloksetin
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink
Croatian: Cymbalta 30 mg želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) zelena tinta, jestiva
English: Cymbalta is for oral use.
Croatian: Cymbalta se uzima kroz usta.
English: Cymbalta 30 mg hard gastro-resistant capsules Duloxetine
Croatian: Cymbalta 30 mg tvrde želučanootporne kapsule duloksetin
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Croatian: Cymbalta 60 mg želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) željezov oksid, žuti (E172) bijela tinta, jestiva
English: Cymbalta should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Croatian: (tj. potentnim inhibitorima CYP1A2) jer se pri toj kombinaciji povećava koncentracija duloksetina u plazmi (vidjeti dio 4.5).
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.
Croatian: Cymbalta u dozi od 60 do 120 mg jednom dnevno bila je statistički značajno superiornija u odnosu na placebo
English: Each capsule contains 60 mg of duloxetine (as hydrochloride)
Croatian: Jedna kapsula sadrži 60 mg duloksetina (u obliku duloksetinklorida).
English: The usual dose of Cymbalta is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Croatian: Za depresiju i bol kod dijabetičke neuropatije: Uobičajena doza lijeka Cymbalta je 60 mg jednom na dan, no liječnik će Vam propisati dozu koja
English: Each capsule contains 30 mg of duloxetine (as hydrochloride)
Croatian: Jedna kapsula sadrži 30 mg duloksetina (u obliku duloksetinklorida).
English: Ejaculation delayed
Croatian: • pojačano zijevanje
English: Investigations
Croatian: ispitivanja.
English: Cymbalta 60 mg Each capsule contains 60 mg of duloxetine (as hydrochloride).
Croatian: TVARI Jedna kapsula sadrži 60 mg duloksetina (u obliku duloksetinklorida)
English: Cymbalta 30 mg Each capsule contains 30 mg of duloxetine (as hydrochloride).
Croatian: TVARI Jedna kapsula sadrži 30 mg duloksetina (u obliku duloksetinklorida)
English: Cymbalta may make you feel sleepy or dizzy.
Croatian: Upravljanje vozilima i strojevima Cymbalta može izazvati pospanost ili omaglicu.
English: ATC vet code: QI09AB02.
Croatian: ATCvet kod: QI09AB02.
English: The preferred application site is the neck muscle behind the ear.
Croatian: Preferirano mjesto primjene je vratni mišić iza uha.
English: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Germany
Croatian: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau
English: max. 3.5 mg
Croatian: 3,5 mg
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove (EMA) http://www.ema.europa.eu/.
English: Water for injections Glutaraldehyde
Croatian: Voda za injekcije Glutaraldehid
English: EXP {month/year}
Croatian: EXP: {mjesec/godina}
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.
Croatian: Djelatna tvar je biološkog podrijetla namijenjena da potakne aktivni imunitet nije propisana Uredbom (EC) 470/2009.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara kako odlagati veterinarsko medicinske proizvode koji vam više nisu potrebni.
English: Aluminium hydroxide (Al(OH)3) Thiomersal
Croatian: Aluminijev hidroksid (Al(OH)3) Tiomersal
English: Only vaccinate healthy animals.
Croatian: Cijepiti samo zdrave životinje.
English: Prior to administration, shake the vaccine carefully.
Croatian: Prije primjene pažljivo protresite cjepivo.
English: Clinical signs such as temporary mild behavioural disturbances can uncommonly be observed after application of Ecoporc SHIGA.
Croatian: Klinički znakovi poput privremenih blagih poremećaja u ponašanju rijetko se primjećuju nakon primjene cjepiva Ecoporc SHIGA.
English: EU/2/13/149/002
Croatian: EU/2/13/149/001 EU/2/13/149/002
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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).
Croatian: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - često (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja od 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinja na 10.000 tretiranih životinja, uključujući izolirana slučajeve).
English: Adjuvant: Aluminium (as hydroxide)
Croatian: Adjuvans: Aluminij (u obliku hidroksida)
English: Commonly a slight rise in body temperature (maximum of 1.7 °C) may occur after injection.
Croatian: Obično se nakon injekcije može javiti blagi porast tjelesne temperature (maksimalno od 1,7 °C).
English: A single intramuscular injection (1 ml) to pigs from the age of 4 days.
Croatian: Injicira se jednokratno (1 ml) svinjama u dobi od četiri dana nadalje.
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.
Croatian: Obično se mogu primijetiti neznatne lokalne reakcije poput blagog otoka na mjestu injekcije (maksimalne veličine 5 mm), ali te reakcije su prolazne i prolaze nakon kratkog vremena (do sedam dana) bez liječenja.
English: But these reactions subside within a short time (maximum of two days) without treatment.
Croatian: Ali te reakcije prolaze nakon kratkog vremena (najviše za dva dana) bez liječenja.
English: ≥ 3.2 x 106 ELISA units
Croatian: ≥ 3,2 x 106 ELISA jedinica
English: 21 days after vaccination
Croatian: 21 dan nakon cijepljenja.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijal dobiven primjenom tih veterinarsko-medicinskih proizvoda mora se odlagati u skladu s lokalnim propisima.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ecoporc SHIGA suspension for injection for pigs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Ecoporc SHIGA suspenzija za injekcije za svinje