natgillin/translations-raw huggingface dataset:
A series of prespecified subgroup PFS analyses showed consistent results across patient subgroups including age (<65 or ≥65 years), race, geographic region, disease site, endocrine therapy resistance, presence of measurable disease, progesterone receptor status, and menopausal status.
≥ 65 let), z rasno pripadnostjo, geografsko regijo, mestom bolezni, odpornostjo proti endokrinemu zdravljenju, prisotnostjo merljive bolezni, statusom progesteronskih receptorjev in z menopavzalnim statusom, pokazale skladne rezultate.
The efficacy and safety of Verzenios in combination with fulvestrant was evaluated in MONARCH 2, a randomised, double-blind, placebo-controlled phase 3 study in women with HR positive, HER2 negative locally advanced or metastatic breast cancer.
Randomizirana študija III. faze MONARCH 2: Zdravilo Verzenios v kombinaciji s fulvestrantom Učinkovitost in varnost zdravila Verzenios v kombinaciji s fulvestrantom so vrednotili v študiji MONARCH 2, randomizirani, dvojno slepi s placebom nadzorovani študiji III. faze pri ženskah s HRpozitivnim, HER2-negativnim lokalno napredovalim ali metastatskim rakom dojk.
Keep the blister card intact
Pretisni omot hranite nepoškodovan.
Increases in ALT and AST were reported in patients receiving abemaciclib.
Pri bolnicah, ki so prejemale abemaciklib, so poročali o povišanih vrednostih ALT in AST.
Treatment with antidiarrhoeal agents, such as loperamide, should be started at the first sign of loose stools.
Priporočila za obvladovanje driske Ob prvih znakih tekočega blata je treba začeti zdravljenje z antidiaroiki, kot je loperamid.
Package leaflet: Information for the patient Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets abemaciclib This medicine is subject to additional monitoring.
Navodilo za uporabo Verzenios 50 mg filmsko obložene tablete Verzenios 100 mg filmsko obložene tablete Verzenios 150 mg filmsko obložene tablete abemaciklib Za to zdravilo se izvaja dodatno spremljanje varnosti.
Each film-coated tablet contains 14 mg of lactose (as monohydrate).
Ena filmsko obložena tableta vsebuje 14 mg laktoze (v obliki monohidrata).
If the CYP3A4 inhibitor is discontinued, the abemaciclib dose should be increased to the dose used prior to the initiation of the CYP3A4 inhibitor (after 3 to 5 half-lives of the CYP3A4 inhibitor).
kakršen je bil pred uvedbo zaviralca CYP3A4 (po 3-5 razpolovnih časih zaviralca CYP3A4).
Neutropenia was reported in patients receiving abemaciclib.
Pri bolnicah, ki so prejemale abemaciklib, so poročali o nevtropeniji.
Patients were randomised in a 2:1 ratio to receive Verzenios 150 mg twice daily plus fulvestrant 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose, versus placebo plus fulvestrant according to the same schedule.
500 mg v enomesečnih razmikih, z dodatnim odmerkom 500 mg dva tedna po prvem odmerku, ali placebo in fulvestrant po enakem urniku.
Figure 1.
Preglednica 1.
- Verzenios 150 mg film-coated tablets are yellow, oval tablets debossed with “Lilly” on one side and “150” on the other.
- Verzenios 150 mg filmsko obložene tablete so rumene ovalne tablete z vtisnjeno oznako „Lilly“ na eni strani in „150“ na drugi.
How to store Verzenios
Shranjevanje zdravila Verzenios
No large change (that is, >20 ms) in the QTcF interval was detected at the mean observed maximal steady state abemaciclib concentration following a therapeutic dosing schedule.
Pri največjih povprečnih opaženih koncentracijah abemacikliba v stanju dinamičnega ravnovesja po terapevtskem urniku odmerjanja niso opazili večjih sprememb (tj. >20 ms) intervala QTcF.
Lilly Hungária Kft. Tel: + 36 1 328 5100
Tel. št.: + 36 1 328 5100
- Verzenios 100 mg film-coated tablets are white, oval tablets debossed with “Lilly” on one side and “100” on the other.
- Verzenios 100 mg filmsko obložene tablete so bele ovalne tablete z vtisnjeno oznako „Lilly“ na eni strani in „100“ na drugi.
Grade 3 or 4 ALT or AST elevations (based on laboratory findings) were reported in 6.1% and 4.2% patients.
Pri 6,1 % in 4,2 % bolnic so poročali o povišanju stopnje 3 ali 4 ALT oz. AST (na podlagi laboratorijskih preiskav).
Eli Lilly Italia S.p.A. Tel: + 39- 055 42571
Tel. št.: + 39- 055 42571
CYP3A4 inhibitors
Zaviralci CYP3A4
• Alteration in sense of taste
• spremenjeno okušanje
- Verzenios 50 mg film-coated tablets are beige, oval tablets debossed with “Lilly” on one side and “50” on the other.
- Verzenios 50 mg filmsko obložene tablete so bež ovalne tablete z vtisnjeno oznako „Lilly“ na eni strani in „50“ na drugi.
b
PRILOGA I
Oral use
za peroralno uporabo
Based on the level of ALT or AST elevation, abemaciclib may require dose modification (see section 4.2).
Glede na povišanje vrednosti ALT ali AST je mogoče potrebna prilagoditev odmerka (glejte poglavje 4.2).
Duration of response [months] (95%CI)
Mediana [meseci] (95 % IZ)
Very common Diarrhoea Vomiting Nausea
Zelo pogosti Nevtropenija Levkopenija Anemija
You must tell your doctor if you become pregnant.
Če zanosite, morate povedati zdravniku.
Verzenios plus aromatase inhibitor
Zdravilo Verzenios in zaviralec aromataze
Abemaciclib plus endocrine therapya All Grades Toxicity
Abemaciklib in endokrino zdravljenjea
No dose adjustment is necessary for patients treated with moderate or weak CYP3A4 inhibitors.
Pri bolnicah, zdravljenih z zmernimi ali šibkimi zaviralci CYP3A4, ni potrebno prilagajanje odmerka, vendar jih je treba skrbno spremljati glede toksičnosti.
How to take Verzenios Recommended dose
Kako jemati zdravilo Verzenios
Very common Infectionsb
Infekcijske in parazitske bolezni Zelo pogosti Okužbeb
Dose adjustments
Prilagajanje odmerkov
0.246, 0.698); in patients who were progesterone receptor negative, the HR was 0.509 (95% CI: 0.325,
Pri bolnicah v pred-/perimenopavzi je bilo razmerje ogroženosti 0,415 (95 % IZ: 0,246, 0,698), pri bolnicah, negativnih za progesteronske receptorje, je HR znašal 0,509 (95 % IZ: 0,325, 0,797).
Contents of the pack and other information What Verzenios contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Verzenios - Učinkovina je abemaciklib.
Verzenios 100 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b)
Verzenios 100 mg filmsko obložene tablete polivinilalkohol (E1203) titanov dioksid (E171) makrogol (E1521) smukec (E553b)
Verzenios contains sodium
Zdravilo Verzenios vsebuje natrij
Abemaciclib is metabolised to several metabolites primarily by cytochrome P450 (CYP) 3A4.
predvsem s citokromom P450 (CYP) 3A4.
Verzenios 100 mg
PODATKI V BRAILLOVI PISAVI Verzenios 100 mg
Figure 2.
Preglednica 2.
Verzenios 150 mg
PODATKI V BRAILLOVI PISAVI Verzenios 150 mg
Verzenios plus fulvestrant
Zdravilo Verzenios in fulvestrant
Progression-free survival (PFS) was significantly prolonged in the Verzenios plus aromatase inhibitor (AI) arm, (Hazard Ratio [HR] of 0.540 [95% CI, 0.418 to 0.698]); median PFS was 28.18 months in the Verzenios plus AI arm and was 14.76 months in the placebo plus AI arm.
Verzenios in zaviralec aromataze (AI), (razmerje ogroženosti [HR] 0,540 [95 % IZ, 0,418-0,698]); mediani PFS je bil 28,18 meseca v skupini, ki je prejemala zdravilo Verzenios in AI, ter 14,76 meseca v skupini, ki je prejemala placebo in AI.
A reduction in the risk of disease progression or death was observed in patients with visceral disease, (HR of 0.567 [95% CI: 0.407, 0.789]), median PFS 21.6 months versus 14.0 months; in patients with bone-only disease (HR 0.565, [95% CI: 0.306, 1.044]); and in patients with measurable disease (HR 0.517, [95% CI: 0.392, 0.681]).
0,407, 0,789], mediani PFS 21,6 meseca v primerjavi s 14,0 meseci), pri bolnicah z boleznijo samo v kosteh (HR 0,565, [95 % IZ: 0,306, 1,044]) in pri bolnicah z merljivo boleznijo (HR 0,517, [95 % IZ:
Dose modification is recommended for patients who develop Grade 3 or 4 neutropenia (see section 4.2).
Pri bolnicah, pri katerih se pojavi nevtropenija stopnje 3 ali 4, je priporočljivo prilagoditi odmerek (glejte poglavje 4.2).
Each film-coated tablet contains 100 mg abemaciclib.
Ena filmsko obložena tableta vsebuje 100 mg abemacikliba.
Each film-coated tablet contains 50 mg abemaciclib.
Ena filmsko obložena tableta vsebuje 50 mg abemacikliba.
Dose modification is recommended for patients who develop Grade 3 or 4 ALT or AST increase (see section 4.2).
Pri bolnicah, pri katerih se pojavi povišanje vrednosti ALT ali AST stopnje 3 ali 4, je priporočljivo prilagoditi odmerek (glejte poglavje 4.2).
Eli Lilly Nederland B.V. Tel: +372 6 817 280
Tel. št.: +372 6 817 280
• Dizziness
• izpuščaj
Each film-coated tablet contains 150 mg abemaciclib.
Ena filmsko obložena tableta vsebuje 150 mg abemacikliba.
• Verzenios 150 mg film-coated tablet: each tablet contains 150 mg abemaciclib.
• Verzenios 150 mg filmsko obložena tableta: ena tableta vsebuje 150 mg abemacikliba.
Verzenios 100 mg film-coated tablets Each film-coated tablet contains 100 mg abemaciclib.
Verzenios 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg abemacikliba.
Contact your doctor immediately for any of the following: - Symptoms such as chills or fever.
Nemudoma se posvetujte z zdravnikom, če opazite katerega koli od naslednjih učinkov:
A series of prespecified subgroup PFS analyses showed consistent results across patient subgroups including age (<65 or ≥65 years), disease site, disease setting (de novo metastatic vs recurrent metastatic vs locally advanced recurrent), presence of measurable disease, progesterone receptor status, and baseline ECOG performance status.
Vnaprej opredeljene analize PFS so v vseh podskupinah bolnic, vključno s starostjo (< 65 ali ≥ 65 let),
Verzenios 150 mg film-coated tablets Each film-coated tablet contains 150 mg abemaciclib.
Verzenios 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg abemacikliba.
• Verzenios 100 mg film-coated tablet: each tablet contains 100 mg abemaciclib.
• Verzenios 100 mg filmsko obložena tableta: ena tableta vsebuje 100 mg abemacikliba.
Verzenios 50 mg film-coated tablets Each film-coated tablet contains 50 mg abemaciclib.
Verzenios 50 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 50 mg abemacikliba.
Verzenios 50 mg
PODATKI V BRAILLOVI PISAVI Verzenios 50 mg
Verzenios 150 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172)
Verzenios 150 mg filmsko obložene tablete polivinilalkohol (E1203) titanov dioksid (E171) makrogol (E1521) smukec (E553b) rumeni železov oksid (E172)
Verzenios 50 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172) iron oxide red (E172)
Verzenios 50 mg filmsko obložene tablete polivinilalkohol (E1203) titanov dioksid (E171) makrogol (E1521) smukec (E553b) rumeni železov oksid (E172)
• Verzenios 50 mg film-coated tablet: each tablet contains 50 mg abemaciclib.
• Verzenios 50 mg filmsko obložena tableta: ena tableta vsebuje 50 mg abemacikliba.
Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
Tel. št.: + 31-(0) 30 60 25 800
EU/1/18/1307/007 (14 film-coated tablets) EU/1/18/1307/008 (168 film-coated tablets) EU/1/18/1307/009 (28 x 1 film-coated tablets) EU/1/18/1307/014 (28 film-coated tablets) EU/1/18/1307/015 (56 film-coated tablets) EU/1/18/1307/020 (42 film-coated tablets) EU/1/18/1307/021 (70 film-coated tablets)
EU/1/18/1307/007 (14 filmsko obloženih tablet) EU/1/18/1307/008 (168 filmsko obloženih tablet) EU/1/18/1307/009 (28 x1 filmsko obložena tableta) EU/1/18/1307/014 (28 filmsko obloženih tablet) EU/1/18/1307/015 (56 filmsko obloženih tablet) EU/1/18/1307/020 (42 filmsko obloženih tablet) EU/1/18/1307/021 (70 filmsko obloženih tablet)
The median time to onset of Grade 3 or 4 neutropenia was 29 to 33 days, and median time to resolution was 11 to 15 days.
Mediani čas do pojava nevtropenije stopnje 3 ali 4 je bil od 29
• Tiredness
• omotica
EU/1/18/1307/001 (14 film-coated tablets) EU/1/18/1307/002 (168 film-coated tablets) EU/1/18/1307/003 (28 x 1 film-coated tablets) EU/1/18/1307/010 (28 film-coated tablets) EU/1/18/1307/011 (56 film-coated tablets) EU/1/18/1307/016 (42 film-coated tablets) EU/1/18/1307/017 (70 film-coated tablets)
EU/1/18/1307/001 (14 filmsko obloženih tablet) EU/1/18/1307/002 (168 filmsko obloženih tablet) EU/1/18/1307/003 (28 x1 filmsko obložena tableta) EU/1/18/1307/010 (28 filmsko obloženih tablet) EU/1/18/1307/011 (56 filmsko obloženih tablet) EU/1/18/1307/016 (42 filmsko obloženih tablet) EU/1/18/1307/017 (70 filmsko obloženih tablet)
EU/1/18/1307/004 (14 film-coated tablets) EU/1/18/1307/005 (168 film-coated tablets) EU/1/18/1307/006 (28 x 1 film-coated tablets) EU/1/18/1307/012 (28 film-coated tablets) EU/1/18/1307/013 (56 film-coated tablets) EU/1/18/1307/018 (42 film-coated tablets) EU/1/18/1307/019 (70 film-coated tablets)
EU/1/18/1307/004 (14 filmsko obloženih tablet) EU/1/18/1307/005 (168 filmsko obloženih tablet) EU/1/18/1307/006 (28 x1 filmsko obložena tableta) EU/1/18/1307/012 (28 filmsko obloženih tablet) EU/1/18/1307/013 (56 filmsko obloženih tablet) EU/1/18/1307/018 (42 filmsko obloženih tablet) EU/1/18/1307/019 (70 filmsko obloženih tablet)
Suspend dose until toxicity resolves to Grade 2 or less.
Prekinite odmerjanje do izboljšanja na stopnjo 2 ali nižjo.
Verzenios 150 mg film-coated tablets abemaciclib
Verzenios 150 mg filmsko obložene tablete abemaciklib
Verzenios 50 mg tablets abemaciclib
IME ZDRAVILA Verzenios 50 mg tablete abemaciklib
Discuss contraception with your doctor if there is any possibility that you may become pregnant.
Če obstaja možnost, da lahko zanosite, se posvetujte z zdravnikom glede kontracepcije.
Verzenios 50 mg film-coated tablets abemaciclib
Verzenios 50 mg filmsko obložene tablete abemaciklib
Always take this medicine exactly as your doctor or pharmacist has told you.
Priporočeni odmerek Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
Verzenios 100 mg film-coated tablets abemaciclib
Verzenios 100 mg filmsko obložene tablete abemaciklib
Verzenios 150 mg tablets abemaciclib
IME ZDRAVILA Verzenios 150 mg tablete abemaciklib
Tabulated list of adverse reactions
Preglednice z neželenimi učinki
de la Industria 30, 28108 Alcobendas, Madrid, Spain For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
o Clarithromycin (antibiotic used to treat bacterial infections)
o klaritromicin (antibiotik, ki se uporablja za zdravljenje bakterijskih okužb), o itrakonazol, ketokonazol, posakonazol, vorikonazol (uporabljajo se za zdravljenje glivičnih okužb),
Verzenios 150 mg abemaciclib
IME ZDRAVILA Verzenios 150 mg abemaciklib
Verzenios 100 mg tablets abemaciclib
IME ZDRAVILA Verzenios 100 mg tablete abemaciklib
Suspend dose until toxicity resolves to Grade 1 or less.
Prekinite odmerjanje do izboljšanja na stopnjo 1 ali manj.
Verzenios 100 mg abemaciclib
IME ZDRAVILA Verzenios 100 mg abemaciklib
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 150 MG FILM-COATED TABLETS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 150 MG FILMSKO OBLOŽENE TABLETE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 100 MG FILM-COATED TABLETS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 100 MG FILMSKO OBLOŽENE TABLETE
Breast-feeding
Limfopenija
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 100 MG FILMCOATED TABLETS
PRETISNI OMOT, KI BO UPORABLJEN V NOTRANJOSTI KOLEDARSKEGA PRETISNEGA OMOTA ZA 100 MG FILMSKO OBLOŽENE TABLETE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 50 MG FILM-COATED TABLETS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 50 MG FILMSKO OBLOŽENE TABLETE
Alanine aminotransferase increased Aspartate aminotransferase increased a
Povečana vrednost aminotransferaz
Very common Decreased appetite
Zelo pogosti Sprememba okusa Omotica
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 50 MG FILMCOATED TABLETS
PRETISNI OMOT, KI BO UPORABLJEN V NOTRANJOSTI KOLEDARSKEGA PRETISNEGA OMOTA ZA 50 MG FILMSKO OBLOŽENE TABLETE
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 150 MG FILMCOATED TABLETS
PRETISNI OMOT, KI BO UPORABLJEN V NOTRANJOSTI KOLEDARSKEGA PRETISNEGA OMOTA ZA 150 MG FILMSKO OBLOŽENE TABLETE
Verzenios 50 mg abemaciclib
IME ZDRAVILA Verzenios 50 mg abemaciklib
Frequency Preferred term
Priporočeni izraz
You should avoid becoming pregnant while taking Verzenios.
Med jemanjem zdravila Verzenios se izogibajte zanositvi.
Verzenios 150 mg film-coated tablets
KOLEDARSKI PRETISNI OMOT ZA 150 MG FILMSKO OBLOŽENE TABLETE
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER FOR 100 MG FILM-COATED TABLETS
PERFORIRANI ENOODMERNI PRETISNI OMOT ZA 100 MG FILMSKO OBLOŽENE TABLETE
Pruritus Rash Common Dry skin
Pogosti Suha koža
Dose modification is recommended for patients who develop ≥ Grade 2 diarrhoea (see section 4.2).
Pri bolnicah, pri katerih se pojavi driska stopnje 2 ali višje, je priporočljivo prilagoditi odmerek (glejte poglavje 4.2).
Very common Neutropenia Leukopenia Anaemia Thrombocytopenia Common Lymphopenia Uncommon Febrile neutropenia
Žilne bolezni Pogosti Venska trombembolijac Bolezni prebavil Zelo pogosti Driska Bruhanje Slabost Bolezni kože in podkožja Zelo pogosti Alopecija Pruritus
Verzenios 50 mg film-coated tablets
KOLEDARSKI PRETISNI OMOT ZA 50 MG FILMSKO OBLOŽENE TABLETE
Gastrointestinal disorders
Trombocitopenija Pogosti
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER FOR 50 MG FILM-COATED TABLETS
PERFORIRANI ENOODMERNI PRETISNI OMOT ZA 50 MG FILMSKO OBLOŽENE TABLETE
Objective response rateb [%] (95% CI)
[%] (95 % IZ)
Investigator assessment, number of events
Neodvisni radiografski pregled, število dogodkov (%)
Sat.
bolnic.
In patients who were pre/perimenopausal, the hazard ratio was 0.415 (95% CI:
Zmanjšanje tveganja za napredovanje bolezni ali smrt so opazili pri bolnicah z visceralno boleznijo (HR 0,567 [95 % IZ:
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER FOR 150 MG FILM-COATED TABLETS
PERFORIRANI ENOODMERNI PRETISNI OMOT ZA 150 MG FILMSKO OBLOŽENE TABLETE
Verzenios 100 mg film-coated tablets
KOLEDARSKI PRETISNI OMOT ZA 100 MG FILMSKO OBLOŽENE TABLETE
These measures should help to protect the environment.
Ti ukrepi pomagajo varovati okolje
Date of first authorisation: 24/07/2009 Date of last renewal: 06/06/2014
Datum pridobitve dovoljenja za promet: 24/07/2009 Datum zadnjega podaljšanja dovoljenja za promet: 06/06/2014
In case of such reactions, appropriate treatment is recommended.
V takih primerih se priporoča ustrezno zdravljenje.
ATC Vet Code: QI09AA07
Oznaka ATC vet: QI09AA07
The benefit of the vaccination of pigs with very high levels of maternally-derived antibodies, e.g. due to vaccination of their mothers, has not been demonstrated.
Korist cepljenja prašičev z zelo visokimi nivoji maternalnih protiteles, npr. zaradi cepljenja njihovih mater, ni bila dokazana.
Use vaccination devices according to the manufacturer's instructions.
Naprave za cepljenje uporabite v skladu s proizvajalčevimi navodili za uporabo.
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.
Učinkovina, ki je v osnovi biološkega izvora namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe (ES) št. 470/2009.
Store and transport refrigerated (2 °C - 8 °C).
Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
The vaccine is to be administered aseptically.
Cepivo je treba aplicirati aseptično.
Interactions with other medicinal products and other forms of interaction:
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij:
Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Vsakdo, ki namerava proizvajati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo, se mora najprej posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti prepovedane v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodnilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove proizvajanje, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovi da:
a) The administration of the veterinary medicinal product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) Bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
These clinical signs normally resolve without treatment.
Običajno ti znaki minejo sami, brez zdravljenja.
One injection from 21 days of age.
Ena injekcija po 21 dnevu starosti.
Lot {number}
Lot {številka}
The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur.
Področje lokalne tkivne reakcije je ponavadi manjše od 5 cm v premeru, vendar se lahko občasno pojavi večja oteklina.
Due to new field strains (PCV genotype), lack of expected efficacy (LEE) events should be submitted electronically on a yearly basis.
Zaradi novih divjih sevov (PCV genotip), pomanjkanja pričakovane učinkovitosti (PPU) je treba dogodke oddati elektronsko in na letni osnovi.
b) The disease to which the product is intended to confer immunity is largely absent from the territory in question.
b) Bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.
Vaccination schedule:
Načrt cepljenja:
Pigs (piglets) from 3 weeks of age.
Prašiči (pujski), starejši od 3 tednov.
It is intended to stimulate active immunity against PCV2 in piglets.
Namenjen je stimulaciji aktivne imunosti proti PCV2 pri pujskih.
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC so bodisi dovoljenje snovi, za katere, tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
Overdose (symptoms, emergency procedures, antidotes):
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi):