FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Entresto's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Entresto večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Entresto is available as tablets (24 mg sacubitril / 26 mg valsartan, 49 mg sacubitril / 51 mg valsartan, and 97 mg sacubitril / 103 mg valsartan).
Slovenian: Zdravilo Entresto je na voljo v obliki tablet (24 mg sakubitrila/26 mg valsartana, 49 mg sakubitrila/51 mg valsartana in 97 mg sakubitrila/103 mg valsartana).
English: A risk management plan has been developed to ensure that Entresto is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Entresto je bil pripravljen načrt obvladovanja tveganj.
English: What benefits of Entresto have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Entresto izkazalo v študijah?
English: The full EPAR and risk management plan summary for Entresto can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Entresto ste na voljo na spletni strani agencijeema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What are the risks associated with Entresto?
Slovenian: Kakšna tveganja so povezana z zdravilom Entresto?
English: This is a summary of the European public assessment report (EPAR) for Entresto.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Entresto.
English: Why is Entresto approved?
Slovenian: Zakaj je bilo zdravilo Entresto odobreno?
English: What is Entresto and what is it used for?
Slovenian: Kaj je zdravilo Entresto in za kaj se uporablja?
English: The recommended starting dose is one tablet of Entresto 49 mg / 51 mg twice a day and the dose is then doubled after 2 to 4 weeks to 97 mg / 103 mg twice a day.
Slovenian: Tablete zdravila Entresto se jemljejo dvakrat na dan. Priporočeni začetni odmerek je ena tableta zdravila Entresto 49 mg/51 mg dvakrat na dan, po 2 do 4 tednih pa se odmerek podvoji na 97 mg/103 mg dvakrat na dan.
English: Valsartan is an ‘angiotensin-II-receptor antagonist', which means that it blocks the action of a hormone called angiotensin II.
Slovenian: Valsartan je "antagonist receptorjev za angiotenzin II", kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
English: It is used in adults with long-term heart failure who have symptoms of the disease.
Slovenian: Uporablja se pri odraslih z dolgotrajnim srčnim popuščanjem, ki imajo simptome bolezni.
English: For further information, see the summary of product characteristic (also part of the EPAR).
Slovenian: Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Patients in the study had long-term heart failure with symptoms of the disease and reduced ejection fraction (the proportion of blood leaving the heart).
Slovenian: Bolniki v študiji so imeli dolgotrajno srčno popuščanje s simptomi bolezni in zmanjšanim iztisnim deležem (deležem krvi, ki zapušča srce).
English: The effects of angiotensin II can be harmful in patients with heart failure.
Slovenian: Učinki angiotenzina II so pri bolnikih s srčnim popuščanjem škodljivi.
English: Heart failure is the inability of the heart to pump enough blood around the body.
Slovenian: Srčno popuščanje je stanje, pri katerem srce ne more črpati dovolj krvi po telesu.
English: Valsartan, one of the active substances in the medicine, is well established for the treatment of high blood pressure and heart failure; its side effects are well known.
Slovenian: Valsartan, ena izmed zdravilnih učinkovin zdravila, je dobro uveljavljen za zdravljenje visokega krvnega tlaka in srčnega popuščanja; njegovi neželeni učinki so dobro poznani.
English: Sacubitril blocks the breakdown of natriuretic peptides produced in the body.
Slovenian: Sakubitril zavira razgradnjo natriuretičnih peptidov, ki nastajajo v telesu.
English: It must not be taken by patients who have suffered angioedema, those who have severe liver disease or by women who are pregnant.
Slovenian: Bolniki, ki so že imeli angioedem, bolniki s težko jetrno boleznijo ali nosečnice ga ne smejo jemati.
English: Entresto can only be obtained with a prescription.
Slovenian: Izdaja zdravila Entresto je le na recept.
English: Natriuretic peptides cause sodium and water to pass into the urine thereby reducing the strain on the heart.
Slovenian: Natriuretični peptidi povzročijo prehajanje natrija in vode v urin ter tako zmanjšujejo obremenitev srca.
English: Entresto must not be taken with medicines known as ACE inhibitors (which are used to treat heart failure and high blood pressure).
Slovenian: Zdravilo Entresto se ne sme jemati skupaj z zdravili, znanimi kot zaviralci ACE (ki se uporabljajo za zdravljenje srčnega popuščanja in visokega krvnega tlaka).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Entresto, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu z njim so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The two active substances in Entresto, sacubitril and valsartan, work in different ways.
Slovenian: Zdravilni učinkovini v zdravilu Entresto, sakubitril in valsartan, delujeta na različna načina.
English: Entresto is a heart medicine that contains the active substances sacubitril and valsartan.
Slovenian: Entresto je zdravilo za srce, ki vsebuje zdravilni učinkovini sakubitril in valsartan.
English: The most common side effects with Entresto (which may affect more than 1 in 10 people) are high blood potassium levels, low blood pressure and the kidneys working less well.
Slovenian: Najpogostejši neželeni učinki zdravila Entresto (ki lahko prizadenejo več kot 1 osebo od 10) so visoka koncentracija kalija v krvi, nizek krvni tlak in slabše delovanje ledvic.
English: For practical information about using Entresto, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Entresto naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The main study found that Entresto reduced deaths from heart and circulation problems or hospital admissions for heart failure.
Slovenian: V glavni študiji so ugotovili, da zdravilo Entresto zmanjša število smrti, ki so posledica težav s srcem in obtokom, ter število sprejemov v bolnišnico zaradi srčnega popuščanja.
English: By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone's harmful effects on the heart and it also reduces blood pressure by allowing blood vessels to widen.
Slovenian: Z blokado receptorjev, na katere so običajno veže angiotenzin II, valsartan prepreči škodljive učinke hormona na srce in s širjenjem žil zmanjša krvni tlak.
English: For more information about treatment with Entresto, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Entresto preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Entresto's serious side effects in the main study were similar to those of enalapril, which is already authorised for use in heart failure.
Slovenian: Resni neželeni učinki zdravila Entresto v glavni študiji so bili podobni neželenim učinkom enalaprila, ki je že odobren za uporabo pri srčnem popuščanju.
English: For the full list of all side effects reported with Entresto, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Entresto, glejte navodilo za uporabo.
English: In the main study, Entresto was compared to enalapril, another medicine used for heart failure.
Slovenian: V glavni študiji so zdravilo Entresto primerjali z enalaprilom, drugim zdravilom za zdravljenje srčnega popuščanja.
English: The study was stopped early because there was compelling evidence that Entresto was more effective than enalapril.
Slovenian: Študijo so zaradi trdnih dokazov, da je zdravilo Entresto učinkovitejše od enalaprila, predčasno prekinili.
English: A potentially severe side effect, angioedema (rapid swelling of deeper skin tissues as well as the tissues around the throat, causing breathing difficulty), can occur uncommonly (affecting fewer than 1 in 100 people).
Slovenian: Občasno se lahko pojavi potencialno resen neželeni učinek (ki lahko prizadene manj kot 1 osebo od 100), angioedem (hitro otekanje globokih kožnih tkiv in tkiv okrog grla, kar povzroči težave z dihanjem).
English: How is Entresto used?
Slovenian: Kako se zdravilo Entresto uporablja?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom zmanjšajo krvni tlak in srce ščitijo pred razvojem fibroze (nastanka brazgotin), ki se pojavi pri srčnem popuščanju.
English: How does Entresto work?
Slovenian: Kako zdravilo Entresto deluje?
English: All these reactions disappear within 6 days.
Slovenian: Vse te reakcije izginejo v 6 dneh.
English: Do not freeze.
Slovenian: Ne zmrzujte.
English: If such reactions occur, appropriate treatment is recommended.
Slovenian: Če pride do takšnih reakcij, je potrebno ustrezno zdravljenje.
English: In laboratory studies and field trials:
Slovenian: V laboratorijskih študijah in terenskih preskušanjih:
English: ATCvet code: QI09AL08.
Slovenian: Oznaka ATC vet: QI09AL08.
English: Needle length and diameter should be adapted to the age of the animal.
Slovenian: Dolžino in premer igle je treba prilagoditi starosti živali.
English: Homogenous white to nearly white emulsion after shaking.
Slovenian: Homogena bela do skoraj bela emulzija po stresanju.
English: This veterinary medicinal product contains mineral oil.
Slovenian: To zdravilo vsebuje mineralno olje.
English: 30938 Burgwedel GERMANY
Slovenian: 30938 Burgwedel NEMČIJA
English: The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: Učinkovina, ki je v osnovi biološkega izvora, namenjene vzbujanju imunosti, ne spada v področje uporabe Uredbe(ES) št. 470/2009.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - 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).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: 37008 Carbajosa de la Sagrada, Salamanca
Slovenian: 37008 Carbajosa de la Sagrada,
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Podatki niso na voljo.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE IZVEN POGLEDA IN DOSEGA OTROK”
English: Cardboard box
Slovenian: Kartonasta škatla
English: Avoid introduction of contamination.
Slovenian: Pazite, da ne bi prišlo do kontaminacije.
English: To the user:
Slovenian: Namenjeno uporabniku:
English: 2 ml contains:
Slovenian: 2 ml vsebujeta:
English: The excipients (including adjuvants) 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.
Slovenian: SPC, so bodisi dovoljene snovi, za katere tabela 1 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, ne spadajo v področje uporabe Uredbe(ES) št. 470/2009.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki.
English: Milton Keynes Buckinghamshire MK7 7AJ
Slovenian: Milton Keynes Buckinghamshire MK7 7AJ UK
English: Light mineral oil
Slovenian: lahko mineralno olje
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Slovenian: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini razen z zgoraj omenjenim.
English: When PCV2 and/or M. hyopneumoniae infections occur early the two dose vaccination schedule is recommended.
Slovenian: Kadar se okužbe s PCV2 in/ali M. hyopneumoniae pojavijo zgodaj, se priporoča shema cepljenja z dvema odmerkoma.
English: In post marketing experience (with single dose vaccination):
Slovenian: V postmarketinških izkušnjah (po shemi cepljenja z enim odmerkom):
English: Date of first authorisation: 07/11/2014.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 07/11/2014.
English: These reactions disappear within 12 days after the first vaccination of the two dose vaccination schedule and within 3 days after completion of either the single or the two dose vaccination schedule.
Slovenian: Te reakcije izginejo v 12 dneh po prvem cepljenju pri shemi cepljenja z dvema odmerkoma in v 3 dneh po končanju bodisi sheme z enim odmerkom ali sheme z dvema odmerkoma cepljenja.
English: Vaccinate pigs by the intramuscular route in the neck.
Slovenian: Prašiče cepite intramuskularno v vrat.
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated viral and inactivated bacterial vaccines for pigs.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za prašiče (Suidae), inaktivirana virusna in inaktivirana bakterijska cepiva.
English: Safety and efficacy data are available which demonstrate that this vaccine can be given with Porcilis PRRS at the same time at separate sites from 3 weeks of age.
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno dati ob sočasni uporabi cepiva Porcilis PRRS pri različnih mestih dajanja, pri prašičih starejših od 3 tedne.
English: Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Slovenian: Nenamerno injiciranje/samo-injiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst, in lahko v izjemnih primerih, če ni zagotovljena takojšnja zdravniška oskrba, privede do izgube prizadetega prsta.
English: Cardboard box with 1 or 10 vials of 20, 50, 100, 200 or 500 ml.
Slovenian: Kartonasta škatla z 1 ali 10 vialami po 20, 50, 100, 200 ali 500 ml.
English: PET (polyethylene terephthalate) vials of 20, 50, 100, 200 or 500 ml, closed with nitrile rubber stoppers and sealed with aluminium caps.
Slovenian: Viale iz PET (polietilen tereftalat) po 20, 50, 100, 200 ali 500 ml, zaprte z zamaški iz nitrilne gume in aluminijasto zaporko.
English: Accidental injection is dangerous.
Slovenian: Nenamerno injiciranje je nevarno.
English: Special warnings for each target species: Vaccinate only healthy animals.
Slovenian: Posebna opozorila za vsako živalsko vrsto: Cepite samo zdrave živali.
English: Pigs for fattening.
Slovenian: Prašiči pitanci.
English: A transient increase in body temperature very commonly occurs on the day of vaccination (mean ±1 °C, in individual pigs up to 2 °C).
Slovenian: Prehoden dvig telesne temperature se pojavi zelo pogosto na dan cepljenja (povprečno ± 1°C, pri posameznih prašičih do 2°C).
English: Date of last renewal: dd/mm/yyyyy
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: dd/mm/yyyy.
English: Two injections each of 1 ml in pigs starting at 3 days of age with an interval of at least 18 days.
Slovenian: Dve injekciji po 1 ml prašičem pri starosti od 3 dni naprej, v razmiku najmanj 18 dni.
English: Mild systemic reactions may uncommonly be observed up to one day after vaccination and consist of being less active, a tendency of the animal to lie down and minor signs of discomfort.
Slovenian: Blage sistemske reakcije se lahko občasno pojavijo do en dan po cepljenju in se kažejo v zmanjšani aktivnosti živali s tendenco, da bi se ulegle, in z blažjimi znaki nelagodja.
English: Special precautions for use in animals: Not applicable.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih: Ni smiselno.
English: To reduce the loss of daily weight gain during the finishing period in face of infections with Mycoplasma hyopneumoniae and/or PCV2 (as observed in field studies).
Slovenian: Za zmanjšanje izgube dnevnega prirasta v končnem razdobju zaradi okužb z mikoplazmo (Mycoplasma hyopneumoniae) in/ali PCV2 (kot so pokazale terenske študije).
English: Emulsion for injection.
Slovenian: Emulzija za injiciranje.
English: EXP {month/year} Once broached use within 8 hours.
Slovenian: Načeto zdravilo uporabite v 8 urah.
English: The temperature returns to normal from 1 to 2 days after the peak temperature is observed.
Slovenian: Temperatura se normalizira v 1 do 2 dneh po opaženi najvišji temperaturi.
English: Shelf life of the veterinary medical product as packaged for sale: 2 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
English: Shelf life after first opening the container: 8 hours.
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: 8 ur.
English: A hypersensitivity-like reaction may be observed in rare cases after the first vaccination of the two dose vaccination schedule.
Slovenian: V redkih primerih lahko opazimo preobčutljivosti podobne reakcije po prvem cepljenju pri shemi cepljenja z dvema odmerkoma.
English: A single dose of 2 ml in pigs starting at 3 weeks of age.
Slovenian: En odmerek po 2 ml na prašiča pri starosti od 3 tednov naprej.
English: Before using the vaccine allow it to reach room temperature (15 °C - 25 °C) and shake well before use.
Slovenian: Preden cepivo uporabite, naj se ogreje na sobno temperaturo (15 °C do 25 °C).
English: Emulsion for injection
Slovenian: Emulzija za injiciranje
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUG(E)IH SESTAVIN
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
English: PCV2: 18 days after the first vaccination.
Slovenian: PCV2: 18 dni po prvem cepljenju.
English: Transient local injection site reactions, which are restricted to a slight swelling (maximum 2 cm diameter), may commonly occur directly after vaccination, but reactions may not appear until 12 days after vaccination.
Slovenian: Prehodne lokalne reakcije na mestu injiciranja, ki so omejene na rahlo oteklino (s premerom < 2 cm), se občasno pojavijo takoj po dajanju, vendar se reakcija lahko pojavi do 12 dni po cepljenju.
English: Transient local injection site reactions, which are restricted to a slight swelling (< 2 cm diameter), may uncommonly occur.
Slovenian: Prehodne lokalne reakcije na mestu injiciranja, ki so omejene na rahlo oteklino (s premerom < 2 cm), se pojavijo občasno.
English: Intervet International BV 5831 AN Boxmeer The NETHERLANDS
Slovenian: Intervet International BV 5831 AN Boxmeer
English: MSD Animal Health Danube Biotech GmbH Brennaustrasse 1
Slovenian: ŠPANIJA MSD Animal health Danube Biotech GmbH
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALEC ZDRAVILA, ODGOVORENE ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
English: For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection, and severity of lung lesions caused by Mycoplasma hyopneumoniae infection.
Slovenian: Aktivna imunizacija prašičev za zmanjšanje viremije, virusnega bremena v pljučih in limfnih tkivih, izločanja virusov, ki ga povzroča okužba s cirkovirusom prašičev (PCV2), in resnosti pljučnih poškodb, ki jih povzroča okužba z mikoplazmo (Mycoplasma hyopneumoniae).
English: Hypersensitivity reactions after vaccination may occur uncommonly.
Slovenian: Občasno se po cepljenju pojavijo preobčutljivostne reakcije.
English: M. hyopneumoniae inac.
Slovenian: Inaktivirana M. hyopneumoniae
English: Anaphylactic-type reactions, which may be life-threatening, can occur in very rare cases.
Slovenian: Zelo redko se pojavijo reakcije anafilaktičnega tipa, ki so lahko življenjsko ogrožujoče.
English: Porcilis PCV M Hyo emulsion for injection for pigs
Slovenian: Porcilis PCV M Hyo emulzija za injiciranje za prašiče
English: Poligono Industrial EI Montalvo 1 C/Zeppelin 6, Parcela 38
Slovenian: C/Zeppelin 6, Parcela 38
English: Onset of immunity with single dose vaccination: PCV2: 2 weeks after vaccination.
Slovenian: Nastop imunosti po cepljenju z enim odmerkom: PCV2: 2 tedna po cepljenju.
English: M. hyopneumoniae: 21 weeks after (the last) vaccination.
Slovenian: M. hyopneumoniae: 21 tednov po (zadnjem) cepljenju.
English: 1 Antigenic units as determined in the in vitro potency test (ELISA).
Slovenian: 1Enote antigena, določene z in vitro ELISA testom učinkovitosti 2Relativne enote učinkovitost, določene z referenčnim cepivom
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vials of 100, 200 and 500 ml
Slovenian: PODATKI NA STIČNI OVOJNINI Viale po 100, 200 in 500 ml
English: Light mineral oil Aluminium hydroxide Sorbitan oleate Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi lahko mineralno olje aluminijev hidroksid sorbitan oleat polisorbat 80 etilalkohol glicerol natrijev klorid voda za injekcije
English: Aluminium (as hydroxide)
Slovenian: 0,268 ml aluminij (v obliki hidroksida)
English: The product stimulates the development of active immunity against porcine circovirus type 2 and Mycoplasma hyopneumoniae in pigs.
Slovenian: Cepivo vzbuja razvoj aktivne imunosti proti cirkovirusu prašičev tipa 2 in proti Mycoplasma hyopneumoniae pri prašičih.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
English: M. hyopneumoniae: 4 weeks after vaccination.
Slovenian: M. hyopneumoniae: 4 tedne po cepljenju.
English: Per 2 ml: PCV2 ORF2 subunit antigen
Slovenian: PCV2, antigenska podenota ORF2
English: Name and address of the manufacturers of the biological active substances
Slovenian: Ime in naslov proizvajalcev biološke učinkovine Intervet International BV
English: Two dose vaccination schedule:
Slovenian: Shema cepljenja z dvema odmerkoma:
English: Intervet UK Limited Walton Manor Walton,
Slovenian: Intervet UK Limited