FrancophonIA/ELRC3.0 huggingface dataset:
English: The 1-year survival rates were 73.1% in the tacrolimus versus 79.2% in the ciclosporin group.
Slovenian: Enoletno preživetje v skupini s takrolimusom je bilo 73,1 % in v skupini s ciklosporinom 79,2 %, Delež bolnikov brez akutne zavrnitve je bil v skupini s takrolimusom večji po 6 mesecih (57,7 % v prim.
English: Lactation
Slovenian: Izločanje
English: 0.01 - 0.10 mg per kg body weight per day depending on the transplanted organ.
Slovenian: Začetni intravenski odmerki tik po presaditvi so na splošno od 0,01 do 0,10 mg na kg telesne mase na dan,
English: This summary was last updated in 09-2016.
Slovenian: Povzetek je bil nazadnje posodobljen 09-2016.
English: It is designed for long-term use.
Slovenian: Namenjeno je dolgotrajni uporabi.
English: The infusion should last three hours.
Slovenian: Infundiranje naj traja tri ure.
English: These measurements were taken at the start of the study and after a year of treatment.
Slovenian: Meritve so izvedli ob začetku študije in po enem letu zdravljenja.
English: Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto pregledala vse razpoložljive nove informacije in posodobila ta povzetek, če bo to potrebno.
English: Without treatment, these symptoms become more severe over time.
Slovenian: Brez zdravljenja postanejo sčasoma ti simptomi vse resnejši.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Elaprase on 8 January 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Elaprase, veljavno po vsej Evropski uniji, izdala 8. januarja 2007.
English: At the start of the study, the patients could walk an average of around 395 metres in six minutes.
Slovenian: Na začetku študije so bolniki v šestih minutah povprečno lahko prehodili 395 metrov.
English: The CHMP concluded that the improvements shown in the study, even if limited, represent a clinical benefit in the treatment of Hunter syndrome.
Slovenian: CHMP je zaključil, da izboljšanja, ki so jih prikazali v študiji, četudi omejena, pomenijo klinično korist pri zdravljenju Hunterjevega sindroma.
English: What measures are being taken to ensure the safe and effective use of Elaprase?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Elaprase?
English: Elaprase is given every week, as an infusion into a vein, at a dose of 0.5 mg per kilogram body weight.
Slovenian: Zdravilo Elaprase se daje vsak teden kot infuzija v veno v odmerku 0,5 mg na kilogram telesne mase.
English: Elaprase has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Elaprase je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
English: After a year, the patients receiving Elaprase could walk a further 43 metres on average, and the patients receiving placebo could walk a further 8 metres.
Slovenian: Po enem letu so bolniki, ki so prejemali zdravilo Elaprase, lahko prehodili dodatnih 43 metrov, bolniki, ki so prejemali placebo pa 8 metrov.
English: For more information about treatment with Elaprase, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Elaprase preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The Committee decided that Elaprase's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je zaključil, da so koristi zdravila Elaprase večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: The company that markets Elaprase will investigate the long-term effects of the medicine, particularly on the lungs, the heart and the blood vessels, and whether the body produces antibodies that could affect the medicine's safety and effectiveness.
Slovenian: Družba, ki trži zdravilo Elaprase, bo proučila njegove dolgoročne učinke, zlasti na pljuča, srce in krvne žile in raziskala, ali telo proizvaja protitelesa, ki bi lahko vplivala na varnost in učinkovitost zdravila.
English: Other information about Elaprase
Slovenian: Druge informacije o zdravilu Elaprase
English: This is a summary of the European public assessment report (EPAR) for Elaprase.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Elaprase.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Elaprase can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Elaprase je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Hunter syndrome, which is also known as mucopolysaccharidosis II, is a rare, inherited disease that primarily affects male patients.
Slovenian: Hunterjev sindrom, znan tudi kot mukopolisaharidoza tipa II, je redka, dedna bolezen, ki večinoma prizadene moške.
English: Because the number of patients with Hunter syndrome is low, the disease is considered ‘rare', and Elaprase was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 December
Slovenian: Ker je bolnikov s Hunterjevim sindromom malo, velja ta bolezen za redko, zato je bilo zdravilo Elaprase 11. decembra 2001 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Elaprase.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The main measures of effectiveness were lung function (‘forced vital capacity', the maximum amount of air the patient could breathe out), and the distance the patients could walk in six minutes, which measures the combined effects of the illness on the heart, lungs, joints and other organs.
Slovenian: Glavno merilo učinkovitosti je bilo delovanje pljuč (forsirana vitalna kapaciteta, tj. največja količina zraka, ki jo bolnik lahko naenkrat izdihne) in razdalja, ki jo bolnik lahko prehodi v šestih minutah, s čimer se merijo skupni učinki bolezni na srce, pljuča, sklepe in druge organe.
English: This means that because Hunter syndrome is rare, it has not been possible to obtain complete information about Elaprase.
Slovenian: To pomeni, da zaradi redkosti Hunterjevega sindroma o zdravilu Elaprase še ni bilo mogoče pridobiti vseh podatkov.
English: Patients with Hunter syndrome do not produce an enzyme called iduronate-2-sulfatase.
Slovenian: Bolniki s Hunterjevim sindromom ne proizvajajo encima, imenovanega iduronat-2-sulfataza.
English: What benefit has Elaprase shown during the studies?
Slovenian: Kakšne koristi je zdravilo Elaprase izkazalo med študijami?
English: The main study of Elaprase involved 96 male patients aged between 5 and 31 years, and compared it with placebo (a dummy treatment).
Slovenian: V glavni študiji je sodelovalo 96 moških bolnikov v starosti od 5 do 31 let, pri katerih so zdravilo Elaprase primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Slovenian: Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: If given to patients who have had severe allergic reactions in the past, Elaprase should be used with caution, and trained staff and equipment for emergency resuscitation should be available during infusion.
Slovenian: Bolnikom, ki so v preteklosti imeli resno alergijsko reakcijo, je treba zdravilo Elaprase dajati previdno, med infundiranjem pa mora biti na voljo usposobljeno osebje in oprema za oživljanje.
English: Elaprase treatment should be supervised by a doctor or other healthcare professional who has experience in the management of patients with Hunter syndrome or other inherited diseases affecting the metabolism.
Slovenian: Zdravljenje z zdravilom Elaprase mora nadzorovati zdravnik ali strokovni zdravstveni delavec, ki ima izkušnje z zdravljenjem bolnikov s Hunterjevim sindromom ali drugimi dednimi presnovnimi boleznimi.
English: Elaprase must not be used in people who have had a severe or life-threatening allergic (anaphylactic) reaction to idursulfase or any of the other ingredients if their allergy is not controllable.
Slovenian: Zdravila Elaprase ne smejo uporabljati osebe, ki so v preteklosti imele resno ali smrtno nevarno alergijsko (anafilaktično) reakcijo na idursulfazo ali katero koli drugo sestavino zdravila, če njihove alergije ni mogoče nadzorovati.
English: What is the risk associated with Elaprase?
Slovenian: Kakšna tveganja so povezana z zdravilom Elaprase?
English: What information is still awaited for Elaprase?
Slovenian: Katere informacije o zdravilu Elaprase še pričakujemo?
English: The full EPAR for Elaprase 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) za zdravilo Elaprase je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elaprase have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: However, as long as the patient does not develop infusion reactions (rash, itching, fever, headache, high blood pressure or flushing), the duration of the infusion can be gradually reduced to one hour.
Slovenian: Če se pri bolniku ne pojavijo reakcije na infundiranje (izpuščaj, srbenje, povišana telesna temperatura, glavobol, visok krvni tlak ali vročinski oblivi), se lahko infundiranje postopoma skrajša na eno uro.
English: Elaprase is used to treat patients with Hunter syndrome.
Slovenian: Zdravilo Elaprase se uporablja za zdravljenje odraslih s Hunterjevim sindromom.
English: Supplying the enzyme will help to break down GAGs and stop them building up in body tissue, thereby helping to improve the symptoms of the disease.
Slovenian: Nadomeščanje encima pomaga pri razgradnji glikozaminoglikanov, ki se nehajo kopičiti v telesnih tkivih, kar pomaga pri izboljšanju simptomov bolezni.
English: This enzyme is needed to break down substances in the body called glycosaminoglycans (GAGs).
Slovenian: Ta encim telo potrebuje za razgradnjo snovi, imenovanih glikozaminoglikani (GAG).
English: Elaprase idursulfase
Slovenian: Elaprase idursulfaza
English: Other side effects seen in more than 1 patient in 10 are wheezing, dyspnoea (difficulty breathing), abdominal pain (stomach ache), nausea (feeling sick), dyspepsia (heartburn), diarrhoea, vomiting, swelling at the site of infusion and chest pain.
Slovenian: Drugi neželeni učinki, opaženi pri več kot 1 bolniku od 10, so sopenje, dispneja (oteženo dihanje), bolečine v trebuhu, navzeja (slabost), dispepsija (zgaga), driska, bruhanje, otekanje na mestu infundiranja in bolečine v prsnem košu.
English: The most common side effects with Elaprase are related to the infusion, including skin reactions (rash or itching), fever, headache, high blood pressure and flushing.
Slovenian: Najpogostejši neželeni učinki zdravila Elaprase so povezani z infundiranjem, vključno s kožnimi reakcijami (izpuščaj ali srbenje), povišano telesno temperaturo, glavobolom, visokim krvnim tlakom in vročinskimi oblivi.
English: Elaprase is a medicine that contains the active substance idursulfase.
Slovenian: Elaprase je zdravilo, ki vsebuje zdravilno učinkovino idursulfazo.
English: Why has Elaprase been approved?
Slovenian: Zakaj je bilo zdravilo Elaprase odobreno?
English: For the full list of all side effects reported with Elaprase, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Elaprase, glejte navodilo za uporabo.
English: The active substance in Elaprase, idursulfase, is a copy of the human enzyme iduronate-2-sulfatase.
Slovenian: Zdravilna učinkovina zdravila Elaprase, idusulfaza, je kopija človeškega encima iduronat-2-sulfataze.
English: Patients who tolerate the infusions well for several months in a clinic may be able to start having them at home. Home infusions should be supervised by a doctor or nurse.
Slovenian: Bolniki, ki infundiranje v bolnišnici dobro prenašajo več mesecev, ga morda lahko nadaljujejo doma.
English: It replaces the enzyme that is missing or defective in patients with Hunter syndrome.
Slovenian: Nadomešča encim, ki ga bolniki s Hunterjevim sindromom nimajo ali je okvarjen.
English: Elaprase improved lung function and the walking ability of the patients.
Slovenian: Zdravilo Elaprase je pri bolnikih izboljšalo delovanje pljuč in zmožnost hoje.
English: The medicine also produced an improvement in lung function, while the patients on placebo showed a slight worsening.
Slovenian: Tudi delovanje pljuč se je ob jemanju zdravila izboljšalo, ob jemanju placeba pa rahlo poslabšalo.
English: Since patients with Hunter syndrome cannot break these substances down, the GAGs gradually build up in most of the organs in the body and damage them.
Slovenian: Bolniki s Hunterjevim sindromom ne morejo razgraditi teh snovi, ki se zato kopičijo v večini telesnih organov in jih poškodujejo, kar vodi do številnih simptomov, zlasti težav z dihanjem in hojo.
English: Severe allergic reactions have occurred in some patients taking Elaprase.
Slovenian: Pri nekaterih bolnikih, ki so je jemali zdravilo Elaprase, so se pojavile resne alergijske reakcije.
English: How has Elaprase been studied?
Slovenian: Kako je bilo zdravilo Elaprase raziskano?
English: What is Elaprase used for?
Slovenian: Za kaj se zdravilo Elaprase uporablja?
English: How is Elaprase used?
Slovenian: Kako se zdravilo Elaprase uporablja?
English: How does Elaprase work?
Slovenian: Kako zdravilo Elaprase deluje?
English: What is Elaprase?
Slovenian: Kaj je zdravilo Elaprase?
English: 7 days after primary vaccination
Slovenian: 7 dni po primarnem cepljenju
English: Adverse reactions (frequency and seriousness)
Slovenian: Neželeni učinki (pogostost in resnost)
English: Primary vaccination: see above
Slovenian: Primarno cepljenje: glejte zgoraj
English: Store in a refrigerator (2 ºC − 8 ºC).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C).
English: After administration of a double dose (4 ml), no adverse reactions other than those described in section 4.6 were observed.
Slovenian: Po dajanju dvakratnega odmerka (4 ml), niso bili opisani nobeni drugi neželeni učinki kot tisti, opisani v poglavju 4.6.
English: 06861 Dessau-Rosslau Germany
Slovenian: 06861 Dessau-Rosslau Nemčija
English: Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
English: Manufacturer responsible for batch release: IDT Biologika GmbH Am Pharmapark
Slovenian: Izdelovalec, odgovoren za sproščanje serij: IDT Biologika GmbH Am Pharmapark
English: DD/MM/YYYY
Slovenian: DD/MM/LLLL
English: Each dose of 2 ml contains:
Slovenian: Vsak odmerek (2ml) vsebuje:
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Slovenian: Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
English: Sodium chloride solution (0.9 %)
Slovenian: Natrijev klorid, raztopina (0,9 %)
English: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Germany
Slovenian: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Nemčija
English: Carbomer 971 P NF
Slovenian: Karbomer 971 P NF
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je smiselno
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
English: In the latter case piglets should be vaccinated after the age of 96 days.
Slovenian: V zadnjem primeru je potrebno pujske cepiti po 96 dneh starosti.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Slovenian: e opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
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 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.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: Keep the vial in the outer carton in order to protect from light.
Slovenian: Shranjujte vialo v originalni zunanji ovojnini za zaščito pred svetlobo.
English: On very rare occasions, a slight transient rectal temperature increase might occur after vaccination.
Slovenian: Zelo redko se lahko po cepljenju prehodno rahlo poviša rektalna temperatura.
English: It induces neutralizing and haemagglutination inhibiting antibodies against each of the three subtypes.
Slovenian: Inducira nastanek neutralizirajočih protiteles in protiteles, ki zavirajo hemaglutinacijo proti vsakemu od treh podtipov.
English: Use during pregnancy,lactation or lay
Slovenian: Uporaba v obdobju brejosti, laktacije ali nesnosti
English: Clear, yellowish orange to pink colored suspension for injection.
Slovenian: Bistra rumeno-oranžna do rožnato obarvana suspenzija za injiciranje.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports)
Slovenian: Najpogostejši neželeni učinek je v skupini naveden prvi, po naslednjem dogovoru: - Zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali) - Pogosti (pojavijo se pri 1 od 10 živali od 100 živali) - Občasni (pojavijo se pri 1 od 10 živali od 1.000 živali) - Redki (pojavijo se pri 1 od 10 živali od 10.000 živali) - Zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: Shelf-life after first opening the container: 10 hours.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 10 ur.
English: Generally, maternallyderived antibodies induced by vaccination last for approx. 5-8 weeks after birth.
Slovenian: V splošnem, maternalna protitelesa inducirana s cepljenjem vztrajajo približno 5-8 tednov po rojstvu.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini, po EXP.
English: On very rare occasions, a slight transient rectal temperature increase might occur after vaccination (“very rare” corresponds to a frequency of adverse reactions less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: Zelo redko se lahko po cepljenju prehodno rahlo poviša rektalna temperatura (»Zelo redko« pri navajanju neželenih učinkov pomeni pogostost pojavljanja neželenih učinkov manj kot 1 žival na 10.000 živali, vključno s posamičnimi primeru).
English: Carbomer 971 P NF Thiomersal
Slovenian: Karbomer 971 P NF Tiomersal
English: Strains of inactivated Influenza A virus/swine (H3N2) ≥ 10.53 log2 GMNU, (H1N1) ≥ 10.22 log2 GMNU, (H1N2) ≥ 12.34 log2 GMNU
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Sevi inaktiviranega virusa Influenca A /prašiči (H3N2) ≥ 10.53 log2 GMNU, (H1N1) ≥ 10.22 log2 GMNU, (H1N2) ≥ 12.34 log2 GMNU
English: Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.
Slovenian: 4 mesece pri prašičih cepljenih v starosti med 56 in 96 dni 6 mesecev pri prašičih, ki so bili prvič cepljeni po 96 dneh starosti
English: Marketing authorisation holder: MERIAL
Slovenian: Imetnik dovoljenja za promet z zdravilom: MERIAL
English: In particular cases of multiple contacts of the sows with antigens (field infections + vaccination) the antibodies transmitted to the piglets may last until week 12 of life.
Slovenian: V posebnih primerih, ko svinje prihajajo v stik z več antigeni (naravne okužbe in cepljenje), lahko protitelesa, ki jih dobijo pujski, vztrajajo do 12 tedna starosti.
English: Onset of immunity:
Slovenian: Trajanje imunosti:
English: Contraindications
Slovenian: KONTRAINDIKACIJE
English: Interaction with other medicinal products and other forms of interaction
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: Glass vials: 20 ml vials, glass type I 50 ml vials, glass type II 100 ml vials, glass type II
Slovenian: Steklene viale: 20 ml viale, steklo tipa I 50 ml viale, steklo tipa II 100 ml viale, steklo tipa II
English: EXP {month/year} Once opened, use within 10 hours.
Slovenian: Odprto zdravilo uporabite v 10 urah.
English: Bromobutyl rubber stoppers
Slovenian: Zamašek: Bromobutlni gumijasti zamaški
English: Primary vaccination: 2 injections of one dose (2 ml) - From the age of 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 6 months.
Slovenian: Primarno cepljenje: 2 injekciji enega odmerka (2ml) - Od 96. dneva starosti v razmiku 3 tednov za zagotovitev trajanja imunosti 6 mesecev.
English: In case of accidental self-injection only a minor injection site reaction is expected.
Slovenian: V primeru nenamernega samo-injiciranja lahko pride do blage reakcije na mestu injiciranja.
English: Package sizes:
Slovenian: Velikosti pakiranja:
English: Special warnings for the target species
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto
English: Maternally-derived immunity in the piglets interacts with antibody induction.
Slovenian: Maternalna imunost pujskov vpliva na indukcijo protiteles.
English: PACKAGE LEAFLET FOR:
Slovenian: NAVODILO ZA UPORABO ZA:
English: Pregnancy and lactation: The vaccine can be used during pregnancy and lactation.
Slovenian: Brejost in laktacija: Lahko se uporablja v obdobju brejosti in laktacije.
English: PROHIBITION OF SALE; SUPPLY AND/OR USE
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno.
English: or - Between the age of 56 and 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 4 months.
Slovenian: Ali - Med 56. in 96. dnem starosti v razmiku 3 tednov za zagotovitev trajanja imunosti 4 mesece.
English: Read the package leaflet before use.
Slovenian: IM Pred uporabo preberite navodilo za uporabo.