natgillin/translations-raw huggingface dataset:
Response and remission rates were also higher with Cymbalta compared to placebo.
Stopa odgovora na liječenje i stopa remisije bile su također više kod primjene lijeka Cymbalta u usporedbi s placebom.
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.
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.
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.
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.
Cymbalta 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.
Cymbalta 30 mg dostupna je u pakiranjima od 7, 28 i 98 tvrdih želučanootpornih kapsula.
Cymbalta 30 mg Cymbalta 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.
Cymbalta 30 mg Cymbalta 30 mg dostupna je u pakiranjima koja sadrže 7, 28 i 98 tvrdih želučanootpornih kapsula.
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).
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,
Response and remission rates were also statistically significantly higher with Cymbalta compared with placebo.
Stope odgovora na liječenje i remisije bile su također statistički značajno veće pri uzimanju lijeka Cymbalta nego pri uzimanju placeba.
Concomitant use of Cymbalta with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Kontraindicirana je istodobna primjena lijeka Cymbalta s neselektivnim, ireverzibilnim inhibitorima monoaminooksidaze (MAOI) (vidjeti dio 4.5).
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.
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.
Cymbalta may be associated with sedation and dizziness.
Uzimanje lijeka Cymbalta može biti povezano s pojavom sedacije i omaglice.
28 hard gastro-resistant capsules 7 hard gastro-resistant capsules 98 hard gastro-resistant capsules
28 tvrdih želučanootpornih kapsula 7 tvrdih želučanootpornih kapsula 98 tvrdih želučanootpornih kapsula
Excipient(s) with known effect Each capsule may contain up to 111 mg sucrose.
Jedna kapsula može sadržavati do 111 mg saharoze.
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).
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).
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.
3158 bolesnika (1285 bolesnik-godina izloženosti) koji su zadovoljavali DSM-IV kriterije za veliki depresivni poremećaj.
How to take Cymbalta
Kako uzimati lijek Cymbalta
The use of Cymbalta while breastfeeding is not recommended.
Ne preporučuje se uzimanje lijeka Cymbalta za vrijeme dojenja.
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.
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.
Also, you need to wait at least 5 days after you stop taking Cymbalta before you take a MAOI.
Također, nakon što ste prestali uzimati lijek Cymbalta, morate pričekati najmanje 5 dana prije nego počnete uzimati inhibitor MAO.
Photo-sensitivity reactions Increased tendency to bruise Musculoskeletal and connective tissue disorders Musculo-skeletal pain Muscle spasm
Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićno-koštana bol spazam mišića stezanje mišića trzanje mišića trizmus
Cymbalta contains sucrose.
Cymbalta sadrži saharozu.
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)
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)
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.
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.
You must wait at least 14 days after you have stopped taking an MAOI before you can take Cymbalta.
Nakon što ste prestali uzimati inhibitor MAO, morate pričekati najmanje 14 dana prije nego počnete uzimati lijek Cymbalta.
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')
- 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)
Data on the use of Cymbalta 120 mg in elderly patients with major depressive disorder and generalised anxiety disorder are limited.
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.
Cymbalta contains sucrose
Cymbalta sadrži saharozu
Excipient(s) with known effect Each capsule may contain up to 56 mg sucrose.
Jedna kapsula može sadržavati do 56 mg saharoze.
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).
Hamilton Depression Rating Scale, HAM-D) zasnovanom na 17 pokazatelja (uključujući emocionalne i somatske simptome depresije).
Taking a MAOI together with many prescription medicines, including Cymbalta, can cause serious or even life-threatening side effects.
uključujući lijek Cymbalta, može izazvati ozbiljne, čak i po život opasne nuspojave.
Adverse reactions may be more common during concomitant use of Cymbalta and herbal preparations containing St John's wort (Hypericum perforatum).
Pri istodobnom uzimanju lijeka Cymbalta i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
How to store Cymbalta
Kako čuvati lijek Cymbalta
What you need to know before you take Cymbalta DO NOT take Cymbalta if you:
Što morate znati prije nego počnete uzimati lijek Cymbalta
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)
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)
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.
posebno kada je udružena s nedavnom anamnezom promjene ravnoteže tekućina ili s predisponirajućim stanjima za razvoj takvog poremećaja.
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)
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)
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.
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.
Cymbalta 30 mg Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Neprozirno tijelo bijele boje s otisnutom oznakom „30 mg“' i neprozirna plava kapica s otisnutom oznakom „9543“'.
The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with Cymbalta (see section 4.4).
inhibitor i ne smije se davati bolesnicima koji se liječe lijekom Cymbalta (vidjeti dio 4.4).
Cymbalta 30 mg hard gastro-resistant capsules Cymbalta 60 mg hard gastro-resistant capsules
Cymbalta 30 mg tvrde želučanootporne kapsule Cymbalta 60 mg tvrde želučanootporne kapsule
Cymbalta 60 mg Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Neprozirno tijelo zelene boje s otisnutom oznakom „60 mg“ i neprozirna plava kapica s otisnutom oznakom „9542“.
What Cymbalta is and what it is used for What you need to know before you take Cymbalta How to take Cymbalta
Što je Cymbalta i za što se koristi Cymbalta sadrži djelatnu tvar duloksetin.
Cymbalta 60 mg hard gastro-resistant capsules Duloxetine
Cymbalta 60 mg tvrde želučanootporne kapsule duloksetin
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink
Cymbalta 30 mg želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) zelena tinta, jestiva
Cymbalta is for oral use.
Cymbalta se uzima kroz usta.
Cymbalta 30 mg hard gastro-resistant capsules Duloxetine
Cymbalta 30 mg tvrde želučanootporne kapsule duloksetin
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Cymbalta 60 mg želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) željezov oksid, žuti (E172) bijela tinta, jestiva
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).
(tj. potentnim inhibitorima CYP1A2) jer se pri toj kombinaciji povećava koncentracija duloksetina u plazmi (vidjeti dio 4.5).
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.
Cymbalta u dozi od 60 do 120 mg jednom dnevno bila je statistički značajno superiornija u odnosu na placebo
Each capsule contains 60 mg of duloxetine (as hydrochloride)
Jedna kapsula sadrži 60 mg duloksetina (u obliku duloksetinklorida).
The usual dose of Cymbalta is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Za depresiju i bol kod dijabetičke neuropatije: Uobičajena doza lijeka Cymbalta je 60 mg jednom na dan, no liječnik će Vam propisati dozu koja
Each capsule contains 30 mg of duloxetine (as hydrochloride)
Jedna kapsula sadrži 30 mg duloksetina (u obliku duloksetinklorida).
Ejaculation delayed
• pojačano zijevanje
Investigations
ispitivanja.
Cymbalta 60 mg Each capsule contains 60 mg of duloxetine (as hydrochloride).
TVARI Jedna kapsula sadrži 60 mg duloksetina (u obliku duloksetinklorida)
Cymbalta 30 mg Each capsule contains 30 mg of duloxetine (as hydrochloride).
TVARI Jedna kapsula sadrži 30 mg duloksetina (u obliku duloksetinklorida)
Cymbalta may make you feel sleepy or dizzy.
Upravljanje vozilima i strojevima Cymbalta može izazvati pospanost ili omaglicu.
ATC vet code: QI09AB02.
ATCvet kod: QI09AB02.
The preferred application site is the neck muscle behind the ear.
Preferirano mjesto primjene je vratni mišić iza uha.
IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Germany
IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau
max. 3.5 mg
3,5 mg
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove (EMA) http://www.ema.europa.eu/.
Water for injections Glutaraldehyde
Voda za injekcije Glutaraldehid
EXP {month/year}
EXP: {mjesec/godina}
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.
Djelatna tvar je biološkog podrijetla namijenjena da potakne aktivni imunitet nije propisana Uredbom (EC) 470/2009.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Pitajte vašeg veterinara kako odlagati veterinarsko medicinske proizvode koji vam više nisu potrebni.
Aluminium hydroxide (Al(OH)3) Thiomersal
Aluminijev hidroksid (Al(OH)3) Tiomersal
Only vaccinate healthy animals.
Cijepiti samo zdrave životinje.
Prior to administration, shake the vaccine carefully.
Prije primjene pažljivo protresite cjepivo.
Clinical signs such as temporary mild behavioural disturbances can uncommonly be observed after application of Ecoporc SHIGA.
Klinički znakovi poput privremenih blagih poremećaja u ponašanju rijetko se primjećuju nakon primjene cjepiva Ecoporc SHIGA.
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).
- 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).
Adjuvant: Aluminium (as hydroxide)
Adjuvans: Aluminij (u obliku hidroksida)
Commonly a slight rise in body temperature (maximum of 1.7 °C) may occur after injection.
Obično se nakon injekcije može javiti blagi porast tjelesne temperature (maksimalno od 1,7 °C).
A single intramuscular injection (1 ml) to pigs from the age of 4 days.
Injicira se jednokratno (1 ml) svinjama u dobi od četiri dana nadalje.
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.
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.
But these reactions subside within a short time (maximum of two days) without treatment.
Ali te reakcije prolaze nakon kratkog vremena (najviše za dva dana) bez liječenja.
≥ 3.2 x 106 ELISA units
≥ 3,2 x 106 ELISA jedinica
21 days after vaccination
21 dan nakon cijepljenja.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijal dobiven primjenom tih veterinarsko-medicinskih proizvoda mora se odlagati u skladu s lokalnim propisima.
NAME OF THE VETERINARY MEDICINAL PRODUCT Ecoporc SHIGA suspension for injection for pigs
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Ecoporc SHIGA suspenzija za injekcije za svinje
Pharmacotherapeutic group: Immunologicals for suidae, inactivated bacterial vaccines.
IMUNOLOŠKA SVOJSTVA Farmakoterapijska grupa: imunološki preparati za svinje, inaktivirana bakterijska cjepiva.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjujes bilo kojim drugim veterinarsko-medicinskim proizvodom.
Genetically modified recombinant Stx2e antigen:
Genetski modificirani rekombinantni antigen Stx2e:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 50 ml
OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA 50 ml
It is recommended to use a needle appropriate for the age of the piglets (preferred size 21G length 16 mm).
Preporučuje se uporaba igle prikladne za dob praščića (preferirana veličina 21G, duljina 16 mm).
PACKAGE SIZE 50 ml (50 doses) 100 ml (100 doses)
50 ml (50 doza) 100 ml (100 doza)
Date of latest renewal:
Datum posljednjeg produljenja odobrenja:
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna doza od 1 ml sadrži:
The use is not recommended during pregnancy and lactation.. Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kad se koristi s bilo kojim drugim veterinarsko-medicinskim proizvodom.
PET bottle containing 50 ml or 100 ml closed with a bromobutyl rubber stopper and sealed with an aluminium tear-off cap.
PET bočica od 50 ili 100 ml zatvorene čepom od bromobutil-gume i zapečaćene aluminijskom tear-off kapicom.
Onset of immunity:
Trajanje imuniteta:
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.
Cjepivo se sastoji od genetski modificiranog rekombinantnog Stx2e koji stimulira aktivni imunitet na toksin Shiga 2e koji proizvodi uzročnik edemske bolesti svinja.
Between the withdrawals the vaccine should be stored at 2 °C - 8 °C.
Između navlačenja cjepivo treba čuvati na temperaturi od 2 °C - 8 °C.
BATCH NUMBER Lot: {number}
BROJ PROIZVODNE SERIJE Lot: {broj}
MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/001 PET bottle of 50 ml EU/2/13/149/002 PET bottle of 100 ml
EU/2/13/149/001 PET bočica od 50 ml EU/2/13/149/002 PET bočica od 100 ml
Disposal: read package leaflet.
Zbrinjavanje: pročitajte Uputu o VMP.
PHARMACEUTICAL FORM Suspension for injection
OBLIK Suspenzija za injekcije
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).
Aktivna imunizacija praščića u dobi od četiri dana radi smanjenja smrtnosti i kliničkih znakova edemske bolesti uzrokovanih toksinom Stx2e koji proizvodi E. coli (STEC).
In case of accidental self-injection or ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
U slučaju samoinjiciranja ili gutanja odmah potražite liječničku pomoć i pokažite mu uputu ili etiketu
PACKAGE SIZE 100 doses
100 doza
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.
Tablica 1 Priloga Uredbe Komisije (EU) broj 37/2010 prikazuje da MRL nije potreban.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Posebne mjere koje treba uzeti u obzir osoba koja primjenjuje veterinarsko medicinski proizvod na životinjama:
MARKETING AUTHORISATION HOLDER
BROJ ODOBRENJA ZA STAVLJANJE U PROMET
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Ne koristiti u slučaju preosjetljivosti na djelatnu tvar, na adjuvans ili na bilo koju pomoćnu tvar.
SPECIAL WARNINGS Special precautions for use in animals:
Posebne mjere opreza za primjenu na životinjama:
Appearance after shaking: yellowish to brownish, homogenous suspension.
Izgled nakon protresanja: žućkasta do smećkasta homogena suspenzija.
Once opened use within 24 hours (store at 2 °C - 8 °C).
Nakon otvaranja primijeniti unutar 24 sata (čuvati na temperaturi od 2 °C - 8 °C).
4.4 Special warnings for each target species Vaccinate healthy animals only.
4.4 Posebna upozorenja za svaku od ciljnih vrsta životinja
STATEMENT OF ACTIVE SUBSTANCES 1 dose (1 ml) contains:
SASTAV DJELATNIH TVARI 1 doza (1 ml) sadrži:
Pack sizes: Cardboard box with 1 PET bottle of 50 doses (50 ml) or 100 doses (100 ml).
Veličine pakovanja: Kartonska kutija s jednom PET bočicom od 50 doza (50 ml) ili 100 doza (100 ml).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 100 ml
OSNOVNI PODACI NAPISANI NA UNUTARNJEM PAKOVANJU 100 ml
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation 10/04/2013
DATUM PRVOG ODOBRENJA/PRODULJENJA ODOBRENJA
Do not use this veterinary medicinal product after the expiry date which is stated on the label or carton.
Ne koristiti poslije isteka roka valjanosti naznačenog na etiketi ili kutiji.
MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/002 PET bottle
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/13/149/002 PET bočica