FrancophonIA/ELRC3.0 huggingface dataset:
English: The Concerned Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovenian: Zadevne države članice niso mogle doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
English: Portugal and Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Slovenian: Portugalska in Nemčija sta Evropski agenciji za zdravila dne 15. decembra 2004 predložili razloge za nesoglasje.
English: During its September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Lansoprazol-ratiopharm.
Slovenian: Na sestanku v septembru 2005 je CHMP glede na vse predložene podatke ter znanstvene razprave znotraj Odbora menil, da je razmerje med koristmi in tveganji za zdravilo Lansoprazol-ratiopharm ugodno.
English: The final opinion was converted into a Decision by the European Commission on 21 February 2006.
Slovenian: Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 21/02/06.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III.
English: A Marketing Authorisation for Lansoprazol-ratiopharm (15 mg and 30 mg) was previously granted to ratiopharm GmbH in Finland on 7 November 2003.
Slovenian: Dovoljenje za promet z zdravilom Lansoprazol-ratiopharm (15 mg in 30 mg) je bilo predhodno dodeljeno družbi ratiopharm GmbH s Finske 7. novembra 2003.
English: Lansoprazol-ratiopharm (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastro-oesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Slovenian: Lansoprazol-ratiopharm (lansoprazolia) je zaviralec protonske črpalke, ki zavira izločanje želodčne kisline in se uporablja za zdravljenje razjed dvanajstnika in želodca, refluksnega ezofagitisa, gastroezofagealne refluksne bolezni, zdravljenje in preprečevanje razjed želodca in dvanajstnika, povezanih z jemanjem nesteroidnih protivnetnih zdravil (NSAID), zdravljenje Zollinger-Ellisonovega sindroma in v kombinaciji z ustreznim protibakterijskim zdravljenjem za eradikacijo Helicobacter pylori ter preprečevanje ponovitve želodčne razjede pri bolnikih z razjedami, povezanimi s H. pylori.
English: In particular, the data of the bioequivalence of the 2x15 mg capsules and the 30 mg capsules, and the possible need for a reduced dose of lansoprazole in this therapeutic indication.
Slovenian: Še zlasti pa mora predložiti podatke o bioekvivalenci 2x15 mg kapsul in 30 mg kapsul, ter o morebitni potrebi po znižanju odmerka lansoprazola pri tej terapevtski indikaciji.
English: For the 15 mg dosage form the therapeutic indication “Helicobacter pylori eradication” is not approved for the reference medicinal product marketed in Portugal.
Slovenian: Za 15 mg odmerek terapevtska indikacija “eradikacija Helicobacter pylori” ni odobrena za referenčno zdravilo, ki se trži na Portugalskem.
English: The applicant should provide clinical data to support the use of 15 mg capsules for Helicobacter pylori eradication.
Slovenian: Vlagatelj mora predložiti klinične podatke v podporo uporabi 15 mg kapsul za eradikacijo Helicobacter pylori.
English: The Marketing Authorisation Holder provided written explanations on 20 July 2005.
Slovenian: Imetnik dovoljenja za promet z zdravilom je pisna pojasnila predložil 13. aprila 2005.
English: The SPC of the reference product in Germany contains specific doses and dosing schedules for the combinations of lansoprazole and antibiotics recommended for eradication of Helicobacter pylori.
Slovenian: Povzetek glavnih značilnosti zdravila za referenčno zdravilo v Nemčiji vsebuje specifične odmerke in sheme odmerjanja za kombinacije lansoprazola in antibiotikov, priporočenih za eradikacijo Helicobacter pylori.
English: Administration) giving a detailed dosing recommendation for antibiotics, in accordance with “Points to consider on wording of Helicobacter pylori eradication therapy in selected SPC sections”, were agreed by CHMP and a positive opinion was adopted on 15 September 2005.
Slovenian: pisanju besedila za eradikacijsko zdravljenje Helicobacter pylori v izbranih poglavjih Povzetka glavnih značilnosti zdravila”, in 15. septembra 2005 sprejel pozitivno mnenje.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansoprazol-ratiopharm 15 mg and 30 mg International Non-Proprietary Name (INN): Lansoprazole
Slovenian: Lansoprazol-ratiopharm 15 mg in 30 mg Mednarodno nelastniško ime (INN): Lansoprazolia
English: Significant differences in comparison to the reference product have been identified with regard to the indication section of the SPCs.
Slovenian: V primerjavi z referenčnim zdravilom so bile ugotovljene znatne razlike v razdelku o indikacijah v Povzetku glavnih značilnosti zdravila.
English: Significant differences in comparison to the reference product have been identified with regard to the posology section of the SPCs.
Slovenian: V primerjavi z referenčnim zdravilom so bile ugotovljene znatne razlike v razdelku o odmerjanju v Povzetku glavnih značilnosti zdravila.
English: Changes to the SPC section 4.2 (Posology and Methods of
Slovenian: Odbor za zdravila za uporabo v humani medicini je izrazil strinjanje s spremembami v razdelku 4.2 (Odmerjanje in način uporabe) Povzetka glavnih značilnosti zdravila, ki navajajo natančna priporočila glede odmerjanja za antibiotike v skladu s “Točkami, ki jih je treba upoštevati pri
English: The doctor should check the response every four to six weeks and adjust the dose if needed.
Slovenian: Zdravnik mora vsake štiri do šest tednov preveriti bolnikov odziv in po potrebi prilagoditi odmerek.
English: Further information on Somavert can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Somavert.
Slovenian: Nadaljnje informacij o zdravilu Somavert so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Somavert.
English: The maximum dose is 30 mg per day.
Slovenian: Največji dnevni odmerek je 30 mg.
English: The effectiveness was measured by comparing the levels of insulin-like growth factor-I (IGF-I) before and at the end of the study.
Slovenian: Učinkovitost so merili s primerjavo ravni insulinu podobnega rastnega faktorja I (IGF-I) pred začetkom in ob koncu študije.
English: The majority of side effects were mild to moderate and of limited duration.
Slovenian: Neželeni učinki so bili večinoma blagi do zmerni in časovno omejeni.
English: Growth hormone promotes growth during childhood and adolescence.
Slovenian: Ta hormon spodbuja rast v otroštvu in adolescenci.
English: The European Medicines Agency decided that Somavert's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Somavert večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Somavert?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Somavert?
English: The patient first receives a starting dose of 80 mg under medical supervision.
Slovenian: Bolnik najprej prejme začetni 80-miligramski odmerek pod zdravniškim nadzorom.
English: If levels are too high, the doctor may decide not to begin or to stop treatment with Somavert.
Slovenian: Če so ravni previsoke, se zdravnik lahko odloči, da z zdravljenjem z zdravilom Somavert ne začne oziroma da ga prekine.
English: Somavert received a marketing authorisation valid throughout the EU on 13 November 2002.
Slovenian: Za zdravilo Somavert je bilo 13. novembra 2002 izdano dovoljenje za promet, veljavno po vsej EU.
English: IGF-I levels were normal at the end of the study (week 12) in 38.5%, 75% and 82% of patients treated with 10, 15 or 20 mg/day Somavert, respectively, compared with 9.7% of the patients treated with placebo.
Slovenian: Zdravilo Somavert je pri vseh testiranih odmerkih zmanjšalo ravni IGF-I, ki so bile ob koncu študije (12. teden) normalne pri 38,5 %, 75 % oziroma 82 % bolnikov, zdravljenih z 10, 15 oziroma 20 mg zdravila na dan v primerjavi z 9,7 % bolnikov, zdravljenih s placebom.
English: The most common side effects of Somavert (seen in more than 1 in 10 people) were headache, diarrhoea and joint pain.
Slovenian: Najpogostejši neželeni učinki zdravila Somavert (opaženi pri več kot 1 bolniku od 10) so bili glavobol, driska in bolečine v sklepih.
English: As for all medicines, data on the use of Somavert are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Somavert stalno spremljajo.
English: The patient or caregiver can inject Somavert after being trained by a doctor or a nurse.
Slovenian: Bolnik ali negovalec lahko zdravilo injicirata sama, potem ko sta ju za to usposobila zdravnik ali medicinska sestra.
English: Somavert has been studied in 112 patients with acromegaly in a 12-week study.
Slovenian: Zdravilo Somavert so v okviru 12-tedenske študije proučili pri 112 bolnikih z akromegalijo.
English: Other information about Somavert
Slovenian: Druge informacije o zdravilu Somavert
English: Side effects reported with Somavert are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Somavert, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Somavert have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Somavert upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: An overview of Somavert and why it is authorised in the EU
Slovenian: Pregled zdravila Somavert in zakaj je odobreno v EU
English: What benefits of Somavert have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Somavert izkazalo v študijah?
English: Before starting and during treatment with Somavert, the patient should have tests to measure levels of liver enzymes in the blood.
Slovenian: Pred začetkom zdravljenja in med zdravljenjem z zdravilom Somavert je treba pri bolniku opraviti meritve ravni jetrnih encimov v krvi.
English: Afterwards, they received 10, 15 or 20 mg Somavert per day or placebo.
Slovenian: Nato so prejeli 10, 15 ali 20 mg zdravila Somavert na dan ali placebo.
English: Why is Somavert authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Somavert odobreno v EU?
English: For more information about using Somavert, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Somavert glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with Somavert?
Slovenian: Kakšna tveganja so povezana z zdravilom Somavert?
English: Somavert contains the active substance pegvisomant.
Slovenian: Zdravilo Somavert vsebuje učinkovino pegvisomant.
English: Patients received a starting dose of 80 mg Somavert or placebo (a dummy treatment).
Slovenian: Bolniki so prejeli začetni 80-miligramski odmerek zdravila Somavert ali placebo (zdravilo brez zdravilne učinkovine).
English: Somavert is used in patients who did not respond well to surgery and/or radiation therapy, and to treatment with somatostatin analogues (another type of medicine used in acromegaly).
Slovenian: Uporablja se pri bolnikih, ki se niso dobro odzvali na kirurški poseg in/ali obsevanje ali na zdravljenje z analogi somatostatina (druge vrste zdravila, ki se uporablja za zdravljenje akromegalije).
English: The active substance in Somavert, pegvisomant, is very similar to human growth hormone, but it has been designed so that it blocks the receptors to which growth hormone normally attaches itself.
Slovenian: zdravilu Somavert, pegvisomant, je zelo podobna človeškemu rastnemu hormonu, vendar je zasnovana tako, da zavira receptorje, na katere se ta hormon običajno veže.
English: What is Somavert and what is it used for?
Slovenian: Kaj je zdravilo Somavert in za kaj se uporablja?
English: Following this, Somavert is given as an injection of 10 mg once a day.
Slovenian: Zatem se zdravilo Somavert v odmerku 10 mg enkrat dnevno injicira pod kožo.
English: Somavert is available as powder and solvent that are mixed together to make up a solution for injection under the skin.
Slovenian: Zdravilo Somavert je na voljo v obliki praška in vehikla, ki se zmešata v raztopino za injiciranje pod kožo.
English: Somavert can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of acromegaly.
Slovenian: Predpisovanje in izdaja zdravila Somavert je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem akromegalije.
English: For the full list of side effects and restrictions with Somavert, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Somavert glejte navodilo za uporabo.
English: IGF-I is regulated by human growth hormone and causes growth in the body.
Slovenian: Rastni faktor IGF-I, ki povzroča rast v telesu, uravnava človeški rastni hormon.
English: In adults, rather than gaining height, overproduction of growth hormone leads to acromegaly, with overgrowth of bone, swelling of soft tissue (such as the hands and feet),
Slovenian: Prekomerna proizvodnja rastnega hormona pri odraslih povzroča akromegalijo s prekomerno rastjo kosti, otekanjem mehkega tkiva (npr. dlani in stopal), boleznimi srca in drugimi motnjami.
English: Somavert is a medicine used to treat adults with acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults and is caused by the pituitary gland producing excess growth hormone.
Slovenian: Somavert je zdravilo, ki se uporablja za zdravljenje bolnikov z akromegalijo (redko hormonsko motnjo, ki se običajno pojavlja pri odraslih srednjih let, povzroči pa jo hipofiza, ki izloča preveč rastnega hormona).
English: By blocking the receptors, Somavert prevents growth hormone from having an effect, thereby preventing the unwanted growth and other disorders seen in acromegaly.
Slovenian: S tem zdravilo preprečuje delovanje rastnega hormona in posledično tudi nezaželeno rast ter druge motnje, opažene pri akromegaliji.
English: How is Somavert used?
Slovenian: Kako se zdravilo Somavert uporablja?
English: Acromegaly occurs when the pituitary gland at the base of the brain makes too much growth hormone, generally because of a benign (non-cancerous) tumour.
Slovenian: Akromegalija se razvije, če hipofiza, tj. žleza na možganskem dnu, izloča preveč rastnega hormona, običajno zaradi benignega (nerakastega) tumorja.
English: How does Somavert work?
Slovenian: Kako zdravilo Somavert deluje?
English: 2nd injection: after 3 weeks.
Slovenian: 2. injekcija: po 3 tednih.
English: 1st injection: from 1.5 months of age.
Slovenian: 1. injekcija: od 1,5 meseca starosti.
English: a) the administration of the product to animals will interfere with the implementation of 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.
Slovenian: 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.
English: The level of efficacy for other species may differ from that observed in sheep.
Slovenian: Učinkovitost pri drugih vrstah se lahko razlikuje od dokazane učinkovitosti pri ovcah.
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Slovenian: * Relativna potenca pri testu potence pri miših v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri ovcah.
English: Off-white or pink liquid.
Slovenian: Umazano bela ali roza tekočina.
English: Duration of immunity: 12 months after completion of the primary vaccination scheme.
Slovenian: Trajanje imunosti: 12 mesecev po koncu primarne sheme cepljenja.
English: Date of last renewal: 07/01/2016
Slovenian: Datum podaljšanja dovoljenja za promet: 07/01/2016
English: Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Slovenian: Za vsak program ponovnega cepljenja se je potrebno dogovoriti s pristojnimi nacionalnimi organi ali odgovornim veterinarjem, upoštevajoč pri tem lokalno epidemiološko situacijo.
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.
Slovenian: Uporaba tega cepiva je dovoljena le pod posebnimi pogoji zakonodaje EU glede nadzora nad boleznijo modrikastega jezika.
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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Slovenian: 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.
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue virus (BTV).
Slovenian: Pri tej kategoriji živali cepivo uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja in/ali v skladu z veljavnimi smernicami pristojnih nacionalnih organov glede cepljenja proti bolezni modrikastega jezika (BTV).
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po {EXP}.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABEZDRAVILA
English: High density polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer stopper and aluminium seal containing 10, 50 or 120 doses of vaccine.
Slovenian: 20 ml, 100 ml ali 240 ml-viale iz polietilena visoke gostote (HDPE) z zamaškom iz klorobutilnega elastomera in aluminijsko zaporko, ki vsebujejo 10, 50 ali 120 odmerkov cepiva.
English: Vaccination may be followed in most animals by a local reaction at the injection site.
Slovenian: Po cepljenju se lahko pri večini živali pojavi lokalna reakcija na mestu injiciranja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Preprinted carton box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI Vnaprej tiskana kartonska škatla 1 x 20 ml, 1 x 100 ml in 1 x 240 ml
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated .
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku.
English: 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.
Slovenian: Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
English: Shelf life after first opening the immediate packaging: use immediately after broaching.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: Načeto uporabite takoj.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
Slovenian: Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila za uporabo v veterinarski medicini odločamo od primera do primera.
English: Each dose of 2 ml of vaccine contains:
Slovenian: Vsak odmerek (2 ml) cepiva vsebuje:
English: Pregnancy: Can be used during pregnancy.
Slovenian: Brejost: Lahko se uporablja v obdobju brejosti.
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Slovenian: Varnost in učinkovitost cepiva pri plemenskih samcih nista bili ugotovljeni.
English: To stimulate active immunity against Bluetongue virus, serotypes 1 and 8 in sheep.
Slovenian: Za stimulacijo aktivne imunosti proti virusu modrega jezika, serotipa 1 in 8, pri ovcah.
English: Primary vaccination: Administer one dose of 2 ml according to the following vaccination scheme:
Slovenian: Dajte en odmerek (2 ml) v skladu z naslednjim programom cepljenja:
English: Administration of a two-fold overdose may be followed in most animals by a local reaction at the injection site.
Slovenian: Po dajanju dvojnega odmerka se lahko pri večini živali pojavi lokalna reakcija na mestu injiciranja.
English: No data are available on safety in lactating animals.
Slovenian: Podatkov glede varnosti pri živalih v laktaciji ni.
English: PACKAGE LEAFLET: Zulvac 1+8 Ovis suspension for injection for sheep
Slovenian: NAVODILO ZA UPORABO Zulvac 1+8 Ovis suspenzija za injiciranje za ovce
English: These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 9 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 63 days).
Slovenian: Te reakcije so v večini primerov v obliki splošne otekline na mestu injiciranja (ne traja več kot 9 dni) ali kot otipljivi noduli (subkutani granulomi, ki lahko trajajo tudi več kot 63 dni).
English: These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 7 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 48 days).
Slovenian: Te reakcije so v večini primerov v obliki splošne otekline na mestu injiciranja (ne traja več kot 7 dni) ali kot otipljivi noduli (subkutani granulomi, ki lahko trajajo tudi več kot 48 dni).
English: 4.2 Indications for use, specifying the target species Active immunisation of sheep from 1.5 months of age for the prevention* of viraemia caused by Bluetongue virus, serotypes 1 and 8.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija ovac, starejših od 1,5 meseca, za preprečitev* viremije, ki jo povzroča virus bolezni modrikastega jezika, serotipa 1 in 8.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/03/2011.
Slovenian: Datum pridobitve dovoljenja za promet: 14/03/2011
English: Adjuvants: Aluminium hydroxide
Slovenian: aluminijev hidroksid
English: A transient increase in rectal temperature, not exceeding 1.2 °C, may occur commonly during the 24 hours following vaccination.
Slovenian: Do 24 ur po cepljenju se lahko pojavi prehodno povišanje rektalne temperature, ki ne presega 1,2 °C.