natgillin/translations-raw huggingface dataset:
In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with Cymbalta and 23% of patients taking placebo.
V kliničnih preskušanjih so se neželeni učinki ob nenadni prekinitvi zdravljenja pojavili pri približno 45 % bolnikov, ki so jemali zdravilo Cymbalta in pri 23 % bolnikov, ki so dobivali placebo.
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.
Cymbalta 60 mg enkrat na dan se je izkazalo za statistično značilno boljše v primerjavi s placebom (p = 0,004) pri merilu primarnega izida, preprečevanju relapsa depresije, kot so izmerili s časom do relapsa.
If you miss a dose, take it as soon as you remember.
Če ste pozabili vzeti zdravilo Cymbalta Če pozabite vzeti odmerek, ga zaužijte, kakor hitro se spomnite.
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).
Cymbalta v kombinaciji z drugimi centralno delujočimi zdravili ali snovmi, ki vključujejo alkohol in pomirjevala (denimo benzodiazepini, morfinomimetiki, antipsihotiki, fenobarbital, sedirajoči antihistaminiki), potrebna previdnost.
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.
V povezavi z duloksetinom so poročali o midriazi, zato je pri predpisovanju zdravila Cymbalta bolnikom s povišanim intraokularnim tlakom ali s tveganjem za akutni glavkom z zaprtim zakotjem potrebna previdnost.
Cymbalta is used in adults to treat:
Cymbalta pri odraslih se uporablja za zdravljenje: • depresije
The usual dose of Cymbalta is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Običajen odmerek zdravila Cymbalta je 60 mg enkrat na dan, za vas ustrezen odmerek pa vam bo predpisal vaš zdravnik.
Excipient(s) with known effect Each capsule may contain up to 111 mg sucrose.
Ena kapsula lahko vsebuje do 111 mg saharoze.
Your doctor will tell you if you should be taking Cymbalta.
Vaš zdravnik vam bo povedal, če smete jemati zdravilo Cymbalta.
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).
Cymbalta se je izkazala za statistično boljšo kot placebo, kar so izmerili z izboljšanjem skupnega števila točk po Hamiltonovi lestvici za ocenjevanje depresije s 17 postavkami (Hamilton Depression Rating Scale, HAM-D), ki vključuje čustvene in tudi somatske simptome depresije.
Therefore Cymbalta should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Zato zdravila Cymbalta ne smemo dajati skupaj z močnimi zaviralci CYP1A2, denimo s fluvoksaminom (glejte poglavje 4.3).
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.
Učinkovitost zdravila Cymbalta 30-120 mg (prilagodljivo odmerjanje) enkrat na dan pri starejših bolnikih (> 65 let) z generalizirano anksiozno motnjo je bila ocenjena v študiji, ki je pokazala statistično pomembno izboljšanje skupnega števila točk po lestvici HAM-A za bolnike, zdravljene z duloksetinom, v primerjavi z bolniki, ki so prejemali placebo.
In a relapse prevention study, patients responding to 6 months of acute treatment with open-label Cymbalta were randomised to either Cymbalta or placebo for a further 6-months.
V študiji preprečevanja relapsa so bolnike, ki so se odzvali na 6-tedensko akutno zdravljenje z znanim zdravilom Cymbalta, naključno razporedili v skupini, kjer so nadaljnjih 6 mesecev prejemali ali zdravilo Cymbalta ali placebo.
Patients should be instructed that if they experience sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.
Zato je treba bolnikom naročiti, naj se izogibajo potencialno nevarnim nalogam,
Cymbalta must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Zdravila Cymbalta pri bolnikih z obolenjem jeter, ki ima za posledico okvarjeno delovanje jeter, ne smemo uporabljati (glejte poglavji 4.3 in 5.2).
Cymbalta 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.
Cymbalta 30 mg je na voljo v pakiranju po 7, 28 in 98 trdih gastrorezistentnih kapsul.
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.
Cymbalta 30-120 mg enkrat na dan pri starejših bolnikih z generalizirano anksiozno motnjo sta bili podobni kot v študijah z mlajšimi odraslimi bolniki.
How to take Cymbalta
Kako jemati zdravilo Cymbalta
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 je na voljo v pakiranju po 7, 28 in 98 trdih gastrorezistentnih kapsul.
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.
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.
Cymbalta contains the active substance duloxetine.
Zdravilo Cymbalta vsebuje učinkovino duloksetin.
Excipient(s) with known effect Each capsule may contain up to 56 mg sucrose.
Ena kapsula lahko vsebuje do 56 mg saharoze.
Response and remission rates were also higher with Cymbalta compared to placebo.
Ob uporabi zdravila Cymbalta v primerjavi s placebom so bile višje tudi stopnje odziva in remisije.
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.
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.
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)
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)
The use of Cymbalta while breastfeeding is not recommended.
Uporabo zdravila Cymbalta v času dojenja odsvetujemo.
Also, you need to wait at least 5 days after you stop taking Cymbalta before you take a MAOI.
Tudi po prenehanju jemanja zdravila Cymbalta morate počakati vsaj 5 dni, preden lahko vzamete MAOI.
Multipack: 500 (25 packs of 20) hard gastro-resistant capsules Multipack: 100 (5 packs of 20) hard gastro-resistant capsules
Večje pakiranje: 100 (5 pakiranj po 20) trdih gastrorezistentnih kapsul
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-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).
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.
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.
The incidence of relapse during the 6-months double-blind follow-up period was 17% and 29% for duloxetine and placebo, respectively.
Incidenca relapsa v 6-mesečnem obdobju dvojno slepega sledenja je bila 17 % oziroma 29 %
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).
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
Cymbalta with food, drink and alcohol
Zdravilo Cymbalta skupaj s hrano, pijačo in z alkoholom Zdravilo Cymbalta lahko vzamete s hrano ali brez nje.
Cymbalta 30 mg Each capsule contains 30 mg of duloxetine (as hydrochloride).
Cymbalta 30 mg Ena kapsula vsebuje 30 mg duloksetina (v obliki klorida).
9 Estimated frequency based on all clinical trial data.
9 Ocenjena pogostnost temelji na vseh podatkih kliničnih preskušanj.10Ocenjena pogostnost na podlagi kliničnih preskušanj, nadzorovanih s placebom c. Opis izbranih neželenih učinkov
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).
Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila Cymbalta preteči vsaj 5 dni pred začetkom jemanja MAOI
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')
- 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
Photo-sensitivity reactions Increased tendency to bruise Musculoskeletal and connective tissue disorders Musculo-skeletal pain Muscle spasm
Bolezni mišično-skeletnega sistema in vezivnega tkiva mišično-skeletna bolečina mišični krč napetost mišic trzanje mišic trizem
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 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)
The concomitant use of Cymbalta with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Sočasno uporabo zdravila Cymbalta s selektivnimi reverzibilnimi MAOI, kakršen je npr. moklobemid, odsvetujemo (glejte poglavje 4.4).
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.
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,
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).
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)
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.
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
Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
denimo, benzodiazepini, močna zdravila proti bolečinam, antipsihotiki, fenobarbital in antihistaminiki.
Concomitant use of Cymbalta with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Zdravila Cymbalta ne smemo uporabljati sočasno z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4.5).
How to store Cymbalta
Shranjevanje zdravila Cymbalta
Cymbalta 30 mg hard gastro-resistant capsules Cymbalta 60 mg hard gastro-resistant capsules
Cymbalta 30 mg trde gastrorezistentne kapsule Cymbalta 60 mg trde gastrorezistentne kapsule
10Estimated frequency based on placebo-controlled clinical trials.
dvojno slepo, s placebom kontrolirano študijo.
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)
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)
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Cymbalta 60 mg želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132) rumeni železov oksid (E172) užitno belo črnilo
Cymbalta 30 mg Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Neprozorno belo telo z vtisnjenim napisom ‘30 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9543'.
Cymbalta 60 mg Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Neprozorno zeleno telo z vtisnjenim napisom ‘60 mg' ter neprozoren moder pokrovček z vtisnjeno oznako ‘9542'.
Cymbalta 60 mg hard gastro-resistant capsules Duloxetine
Cymbalta 60 mg trde gastrorezistentne kapsule duloksetin
Adverse reactions may be more common during concomitant use of Cymbalta and herbal preparations containing St John's wort (Hypericum perforatum).
Ob sočasni uporabi zdravila Cymbalta in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
Cymbalta contains sucrose.
Zdravilo Cymbalta vsebuje saharozo.
Cymbalta 30 mg hard gastro-resistant capsules Duloxetine
Cymbalta 30 mg trde gastrorezistentne kapsule duloksetin
28 hard gastro-resistant capsules 7 hard gastro-resistant capsules 98 hard gastro-resistant capsules
FARMACEVTSKA OBLIKA IN VSEBINA 28 trdih gastrorezistentnih kapsul 7 trdih gastrorezistentnih kapsul 98 trdih gastrorezistentnih kapsul
Medicinal product subject to medical prescription
Zdravljenje z zdravilom
Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
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
Call your doctor or pharmacist immediately if you take more than the amount of Cymbalta prescribed by your doctor.
Če vzamete večjo količino zdravila Cymbalta, kot vam je predpisal vaš zdravnik, nemudoma pokličite svojega zdravnika ali farmacevta.
Cymbalta is a hard gastro-resistant capsule.
Izgled zdravila Cymbalta in vsebina pakiranja Cymbalta je trda gastrorezistentna kapsula.
Cymbalta is for oral use.
Zdravilo Cymbalta jemljemo peroralno.
Cymbalta contains sucrose
Zdravilo Cymbalta vsebuje saharozo
Glaucoma
Cymbalta.
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink
Cymbalta 30 mg želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132)
Each capsule contains 60 mg of duloxetine (as hydrochloride)
Ena kapsula vsebuje 60 mg duloksetina (v obliki duloksetinijevega klorida).
You must wait at least 14 days after you have stopped taking an MAOI before you can take Cymbalta.
Po prenehanju jemanja MAOI morate počakati vsaj 14 dni,
Renal and urinary disorders Dysuria
Infekcijske in parazitske bolezni laringitis
− are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Cymbalta')
- 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«)
Contains sucrose See leaflet for further information
Shranjevanje zdravila Cymbalta Vsebina pakiranja in dodatne informacije
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).
(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.
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.
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.
Cymbalta 30 mg
PODATKI V BRAILLOVI PISAVI Cymbalta 30 mg
Cymbalta 30 mg hard gastro-resistant capsules.
30 mg trde gastrorezistentne kapsule
Cymbalta 60 mg hard gastro-resistant capsules.
60 mg trde gastrorezistentne kapsule
Reproductive system and breast disorders Erectile dysfunction
Bolezni imunskega sistema anafilaktična reakcija preobčutljivost
Each capsule contains 30 mg of duloxetine (as hydrochloride)
Ena kapsula vsebuje 30 mg duloksetina v obliki duloksetinijevega klorida.
Duloxetine (as hydrochloride)
ob uporabi duloksetina oziroma placeba.
Sugar spheres
Likertove lestvice.
ATC vet code: QI09AB02.
Oznaka ATC vet: QI09AB02.
4.4 Special warnings for each target species Vaccinate healthy animals only.
4.4 Posebna opozorila za vsako ciljno živalsko vrsto Cepite samo zdrave živali.
≥ 3.2 x 106 ELISA units
≥ 3,2 x 106 enot ELISA
The preferred application site is the neck muscle behind the ear.
Najboljše mesto injiciranja je vratna mišica za ušesom.
Prior to administration, shake the vaccine carefully.
Pred uporabo cepivo previdno pretresite.
A single intramuscular injection (1 ml) to pigs from the age of 4 days.
Ena intramuskularna injekcija (1 ml) za prašičke, stare več kot 4 dni.
PACKAGE SIZE 100 doses
VELIKOST PAKIRANJA 100 odmerkov
Only vaccinate healthy animals.
Cepite le zdrave živali.
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.
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.
Pharmacotherapeutic group: Immunologicals for suidae, inactivated bacterial vaccines.
Farmakoterapevtska skupina: Imunološka zdravila za prašiče, inaktivirana bakterijska cepiva.
Commonly a slight rise in body temperature (maximum of 1.7 °C) may occur after injection.
Pogosto se lahko po injiciranju cepiva pojavi rahel dvig telesne temperature (največ za 1,7 °C).
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.
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.
It is recommended to use a needle appropriate for the age of the piglets (preferred size 21G length 16 mm).
Priporoča se uporaba igle, ustrezne za starost prašičkov (najboljša velikost je 21 G, dolžina 16 mm).
Genetically modified recombinant Stx2e antigen:
Gensko modificirani rekombinantni antigen Stx2e:
PET bottle containing 50 ml or 100 ml closed with a bromobutyl rubber stopper and sealed with an aluminium tear-off cap.
Plastenka PET, ki vsebuje 50 ml ali 100 ml, zaprta z zamaškom iz bromobutilne gume, zatesnjena z aluminijasto odtržno zaporko.
However, these reactions subside within a short time (maximum of two days) without treatment.
Vendar te reakcije čez kratek čas (največ dva dni) izzvenijo brez zdravljenja.
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.
Cepivo, sestavljeno iz gensko modificiranega rekombinantnega Stx2e, spodbuja aktivno imunost pred toksinom Shiga 2e, ki ga povzročajo povzročitelji edemske bolezni pri prašičih.
Following the administration of a double dose of vaccine no adverse reactions other than those described in section 4.6 have been observed.
Po uporabi dvojnega odmerka cepiva niso opazili drugih neželenih učinkov, kot tistih, opisanih v poglavju 4.6.
SPECIAL WARNINGS Special precautions for use in animals:
Posebni previdnostni ukrepi za uporabo pri živalih:
Do not use this veterinary medicinal product after the expiry date which is stated on the label or carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini ali zunanji ovojnini.
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 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).
Pregnancy and lactation:
Brejosti in laktacija:
MANUFACTURER'S BATCH NUMBER Lot: {number}
PROIZVAJALČEVA ŠTEVILKA SERIJE Lot: {številka}
Following the administration of a double dose of vaccine no adverse reactions other than those described in section 6 have been observed.
Po uporabi dvojnega odmerka cepiva niso opazili drugih neželenih učinkov, kot tistih, opisanih v poglavju 6.