FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose is one tablet once a day and it must be taken with food.
Slovenian: Priporočeni odmerek je ena tableta enkrat na dan, ki se mora vzeti s hrano.
English: All three active substances are already available in separate medicines in the EU.
Slovenian: Vse tri zdravilne učinkovine so kot ločena zdravila že na voljo v Evropski uniji.
English: The full EPAR for Eviplera 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 Eviplera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Eviplera?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eviplera have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Eviplera, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: For more information about treatment with Eviplera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Eviplera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a summary of the European public assessment report (EPAR) for Eviplera.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Eviplera.
English: The company also presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets given concurrently under similar conditions.
Slovenian: Družba je predstavila tudi študije, s katerimi je pokazala, da se tableta, ki vsebuje vse tri učinkovine, v telesu absorbira enako kot ločene tablete, ki se dajejo sočasno v podobnih pogojih.
English: Other information about Eviplera
Slovenian: Druge informacije o zdravilu Eviplera
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 Eviplera.
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: • rifampicin, rifapentine (antibiotics);
Slovenian: • rifampicin in rifapentin (antibiotika);
English: It also causes fewer side effects in the early stages of treatment and offers the benefit of being taken as one tablet once per day.
Slovenian: Poleg tega povzroča manj neželenih učinkov v zgodnjih fazah zdravljenja in je priročnejše, saj se jemlje v obliki ene tablete enkrat na dan.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Slovenian: Tenofovir je zaviralec nukleotidne reverzne transkriptaze.
English: What benefit has Eviplera shown during the studies?
Slovenian: Kakšne koristi je zdravilo Eviplera izkazalo med študijami?
English: Eviplera must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Eviplera:
Slovenian: Zdravilo Eviplera se ne sme uporabljati skupaj z naslednjimi zdravili, saj lahko pride do znižanja ravni rilpivirina v krvi in posledično zmanjšanja učinkovitosti zdravila Eviplera:
English: Eviplera does not cure HIV-1 infection or AIDS, but it may slow the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Eviplera ne ozdravi okužbe z virusom HIV-1 ali aidsa, lahko pa upočasni slabšanje imunskega sistema in razvoj okužb in bolezni, povezanih z aidsom.
English: What is the risk associated with Eviplera?
Slovenian: Kakšna tveganja so povezana z zdravilom Eviplera?
English: • systemic dexamethasone (a steroid anti-inflammatory and immunosuppressant medicine) except when used as a single dose treatment;
Slovenian: • sistemski deksametazon (steroidno protivnetno in imunosupresivno zdravilo), razen kadar se uporablja v terapiji z enkratnim odmerkom;
English: Eviplera is a medicine that contains the active substances emtricitabine (200 mg), rilpivirine (25 mg) and tenofovir disoproxil (245 mg).
Slovenian: Eviplera je zdravilo, ki vsebuje zdravilne učinkovine emtricitabin (200 mg), rilpivirin (25 mg) in dizoproksiltenofovirat (245 mg).
English: Patients who have HIV and hepatitis B may see a worsening of their liver problems when stopping Eviplera.
Slovenian: Pri bolnikih, ki so okuženi z virusom HIV in hepatitisom B, se ob prenehanju jemanja zdravila Eviplera lahko poslabša stanje jeter.
English: Patients who attained a viral load of less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Slovenian: Bolniki, pri katerih je bilo virusno breme po 48 tednih zdravljenja manjše od 50 HIV-1 RNK kopij/ml, so bili opredeljeni kot bolniki, ki so se odzvali na zdravljenje.
English: Therefore, the CHMP considered that the benefits of Eviplera outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients.
Slovenian: Zato je zaključil, da so koristi zdravila Eviplera večje od z njim povezanih tveganj pri bolnikih z majhno virusno obremenitvijo HIV-1, in priporočil, da se zanj izda dovoljenje za promet pri tej skupini bolnikov.
English: If Eviplera is given together with rifabutin, the doctor should prescribe an additional 25 mg of rilpivirine per day during rifabutin treatment.
Slovenian: Če se zdravilo Eviplera jemlje skupaj z rifabutinom, mora zdravnik med zdravljenjem z rifabutinom predpisati dodatno 25-miligramsko tableto rilpivirina na dan.
English: However, the CHMP noted that there was some risk of HIV-1 developing resistance to rilpivirine and that this risk appeared to be lower in patients with a lower viral load.
Slovenian: Ugotovil je, da obstaja manjše tveganje za razvoj odpornosti virusa HIV-1 za rilpivirin in da se zdi, da je to tveganje manjše pri bolnikih z manjšim virusnim bremenom.
English: The two studies evaluating the effects of switching patients to Eviplera showed that Eviplera was as effective as the previous treatment and maintained the reduction in viral load.
Slovenian: Obe študiji, v katerih so ocenjevali učinke pri bolnikih, ki so prešli na jemanje zdravila Eviplera, sta pokazali, da je bilo zdravilo Eviplera enako učinkovito kot predhodno zdravljenje in da se je zmanjšanje virusne obremenitve ohranilo.
English: It is only used in patients where the virus has not developed resistance to certain anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs), tenofovir or emtricitabine, and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Slovenian: Uporablja se samo pri bolnikih, pri katerih virus še ni razvil odpornosti proti nekaterim zdravilom za zdravljenje okužbe z virusom HIV, imenovanim nenukleozidni zaviralci reverzne transkriptaze (NNRTI), tenofovir ali emtricitabin, in pri katerih so ravni virusa HIV v krvi (virusna obremenitev) manjše od 100 000 HIV-1 RNK kopij/ml.
English: All three active substances block the activity of reverse transcriptase, a viral enzyme that allows HIV-1 to replicate in the cells it has infected.
Slovenian: Vse tri zdravilne učinkovine zavirajo delovanje reverzne transkriptaze, tj. virusnega encima, ki omogoča, da se HIV-1 razmnožuje v celicah, ki jih je okužil.
English: Eviplera is used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Eviplera se uporablja za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: By blocking this enzyme, Eviplera reduces the amount of HIV-1 in the blood and keeps it at a low level.
Slovenian: Zdravilo Eviplera z zaviranjem tega encima zniža količino virusa HIV v krvi in jo zadržuje na nizki ravni.
English: • omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
Slovenian: • omeprazol, esomeprazol, lansoprazol, pantoprazol, rabeprazol (zaviralci protonske črpalke za zniževanje ravni želodčne kisline);
English: If patients need to stop taking one of the active substances or if they need to modify their dose, patients should be switched to separate medicines containing emtricitabine, rilpivirine or tenofovir disoproxil.
Slovenian: Če mora bolnik prenehati jemati eno od zdravilnih učinkovin ali prilagoditi odmerek, mora preiti na jemanje posameznih zdravil, ki vsebujejo emtricitabin, rilpivirin in dizoproksiltenofovirat.
English: The main measure of effectiveness was based on the reduction in viral load.
Slovenian: Glavno merilo učinkovitosti je bilo zmanjšanje virusne obremenitve.
English: In the first study in previously untreated patients, 83% of the patients taking the Eviplera combination responded to treatment compared with 84% of the patients taking a combination with efavirenz.
Slovenian: V prvi študiji s predhodno nezdravljenimi bolniki se je na zdravljenje odzvalo 83 % bolnikov, ki so jemali kombinacijo zdravila Eviplera, v primerjavi s 84 % bolnikov, ki so jemali kombinacijo z efavirenzom.
English: • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for epilepsy);
Slovenian: • karbamazepin, okskarbazepin, fenobarbital, fenitoin (zdravila za zdravljenje epileptičnih napadov);
English: Treatment with Eviplera should be started by a doctor who has experience in the management of HIV infection.
Slovenian: Zdravljenje z zdravilom Eviplera lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
English: Why has Eviplera been approved?
Slovenian: Zakaj je bilo zdravilo Eviplera odobreno?
English: The most common side effects with Eviplera in patients who had not received previous HIV treatment (seen in more than 5 patients in 100) were nausea (feeling sick), dizziness, abnormal dreams, headache, diarrhoea and insomnia.
Slovenian: Najpogostejši neželeni učinki zdravila Eviplera pri bolnikih, ki se predhodno niso zdravili zaradi okužbe z virusom HIV (opaženi pri več kot 5 bolnikih od 100) so navzeja (slabost), omotičnost, nenavadne sanje, glavobol, driska in nespečnost.
English: For the full list of side effects and restrictions with Eviplera, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Eviplera glejte navodilo za uporabo.
English: Eviplera emtricitabine / rilpivirine / tenofovir disoproxil
Slovenian: Povzetek EPAR za javnost emtricitabin/rilpivirin/dizoproksiltenofovirat
English: Rarely, kidney problems may occur in patients taking tenofovir disoproxil.
Slovenian: Redko se lahko pri bolnikih, ki jemljejo dizoproksiltenofovirat, pojavijo težave z ledvicami.
English: Eviplera has been studied in two main studies in patients with HIV-1 who had not received HIV treatment before.
Slovenian: Zdravilo Eviplera so proučili v dveh glavnih študijah z bolniki, ki so bili okuženi z virusom HIV-1 in ki zaradi te okužbe predhodno še niso bili zdravljeni.
English: Patient's previous treatment consisted either of two nucleotide reverse transcriptase inhibitors and another HIV medicine called a boosted protease inhibitor, or the medicine Atripla.
Slovenian: Bolniki so prej jemali bodisi dva zaviralca nukleotidne reverzne transkriptaze in še eno drugo zdravilo za zdravljenje okužbe z virusom HIV, imenovano okrepljeni zaviralec proteaze, bodisi zdravilo Atripla.
English: In the first main study involving 690 patients, Eviplera was compared with a similar combination that had efavirenz in place of rilpivirine.
Slovenian: V prvi glavni študiji, ki je vključevala 690 bolnikov, so zdravilo Eviplera primerjali s podobno kombinacijo, ki je namesto rilpivirina vsebovala efavirenz.
English: The main measure of effectiveness was based on the maintained reduction in viral load.
Slovenian: Glavno merilo učinkovitosti je bila ohranitev zmanjšanja virusne obremenitve.
English: In the second study, 87% of the patients in the rilpivirine group (which included patients taking the Eviplera combination) responded to treatment.
Slovenian: V drugi študiji se je na zdravljenje odzvalo 87 % bolnikov v skupini, zdravljeni z rilpivirinom (ki je vključevala tudi bolnike, ki so jemali kombinacijo zdravila Eviplera).
English: The second main study involving 678 patients compared rilpivirine with efavirenz, both being taken with emtricitabine and tenofovir disoproxil or two other nucleotide reverse transcriptase inhibitors.
Slovenian: V drugi glavni študiji so pri 678 bolnikih rilpivirin primerjali z efavirenzom, pri čemer sta bila oba vzeta z emtricitabinom in dizoproksiltenofoviratom ali dvema drugima zaviralcema nukleotidne reverzne transkriptaze.
English: Eviplera contains three active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; rilpivirine, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Slovenian: Zdravilo Eviplera vsebuje tri zdravilne učinkovine: emtricitabin, ki je nukleozidni zaviralec reverzne transkriptaze, rilpivirin, ki je nenukleozidni zaviralec reverzne transkriptaze (NNRTI), in dizoproksiltenofovirat, ki je predzdravilo tenofovirja, kar pomeni, da se v zdravilno učinkovino tenofovir pretvori v telesu.
English: The Eviplera combination compared well with combinations containing efavirenz.
Slovenian: Kombinacija učinkovin v zdravilu Eviplera je dobro prestala primerjavo s kombinacijami, ki vsebujejo efavirenz.
English: The CHMP concluded that Eviplera was as effective as combinations containing efavirenz.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je zdravilo Eviplera enako učinkovito kot kombinacija, ki vsebuje efavirenz.
English: Eviplera has also been evaluated in 532 patients who were switched from their current HIV treatment to Eviplera.
Slovenian: Zdravilo Eviplera so ocenjevali tudi pri 532 bolnikih, ki so s predhodnih zdravil za zdravljenje okužbe z virusom HIV prešli na jemanje zdravila Eviplera.
English: How has Eviplera been studied?
Slovenian: Kako je bilo zdravilo Eviplera raziskano?
English: This compared with 83% of patients in the efavirenz group.
Slovenian: V skupini, ki je jemala efavirenz, je bilo takih bolnikov 83 %.
English: • St John's wort (a herbal medicine to treat depression and anxiety).
Slovenian: • šentjanževka (rastlinski pripravek za zdravljenje depresije in tesnobe).
English: What is Eviplera used for?
Slovenian: Za kaj se zdravilo Eviplera uporablja?
English: How is Eviplera used?
Slovenian: Kako se zdravilo Eviplera uporablja?
English: What is Eviplera?
Slovenian: Kaj je zdravilo Eviplera?
English: In patients who had received previous HIV treatment, the most common side effects (seen in more than 2 patients in 100) were tiredness, diarrhoea, nausea and insomnia.
Slovenian: Pri bolnikih, ki so predhodno že bili zdravljeni zaradi okužbe z virusom HIV, so bili med neželenimi učinki (opaženi pri več kot 2 bolnikih od 100) najpogostejši utrujenost, driska, slabost in nespečnost.
English: Respect normal aseptic conditions.
Slovenian: Upoštevajte normalne aseptične pogoje.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
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, ki je v osnovi biološkega izvora namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe(ES) št. 470/2009.
English: ATCvet code: QI02AB.
Slovenian: Oznaka ATC vet: QI02AB.
English: Vaccination of animals already infected at the time of vaccination will have no adverse effect.
Slovenian: Cepljenje živali, ki so v času cepljenja že okužene, ne bo imelo nobenega škodljivega učinka.
English: Onset of immunity: not established.
Slovenian: Začetek imunosti: ni določeno.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali), - pogosti (pri več kot 1, toda manj kot 10 živali 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: There are no benefits of the vaccine (as described in the indications for cattle), when used in infected and/or pregnant cows.
Slovenian: Cepivo nima nobenih koristnih učinkov (kot je opisano v indikacijah za govedo), kadar se uporablja pri okuženih in/ali brejih kravah.
English: Whitish, opalescent, homogeneous suspension.
Slovenian: Belkasta, opalescentna, homogena suspenzija.
English: It is advisable to vaccinate all the animals in the herd at the same time.
Slovenian: Priporočljivo je cepiti vse živali v čredi istočasno.
English: 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.
Slovenian: Če opazite kakršne koli stranske učinke ali druge učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
English: Meat, milk and offal: Zero days.
Slovenian: Meso, mleko in organi: Nič dni.
English: Duration of immunity: one year after completion of the primary vaccination course.
Slovenian: Trajanje imunosti: eno leto po končanem osnovnem cepljenju.
English: Since stress could contribute to this adverse reaction, appropriate precautions should be taken to reduce stress as much as possible during the administration of the product.
Slovenian: Ker lahko stres pripomore k tej neželeni reakciji, je potrebno upoštevati ustrezne varnostne ukrepe za zmanjšanje stresa med dajanjem cepiva.
English: > 72 QF Units/ml
Slovenian: > 72 QF enot*/ml
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) ) (če je potrebno)
English: Re-vaccination: Every 9 months, as described for primary vaccination, based on duration of immunity of 280 days.
Slovenian: Revakcinacija: Vsakih 9 mesecev, kot je opisano za osnovno cepljenje, na osnovi trajanja imunosti 280 dni.
English: Each container is closed with a 20 mm bromobutyl rubber stopper and a central tear-off aluminiumplastic cap.
Slovenian: Vsak vsebnik je zaprt z 20 mm gumijastim zamaškom iz bromobutila in centralno aluminijasto plastično kapico, ki se odtrga.
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 {EXP}..
English: Store and transport refrigerated (2 °C - 8 °C).
Slovenian: Shranjujte in prevažajte v hladilniku (2 °C - 8 °C) .
English: Cattle and goats
Slovenian: Govedo in koze
English: Date of first authorisation: 30/09/2010.
Slovenian: Datum pridobitve dovoljenja za promet: 30/09/2010 Datum zadnjega podaljšanja dovoljenja za promet: 31/07/2015
English: > 72 QF Units* *QF (Q fever) Unit: relative potency of phase I antigen measured by ELISA in comparison with a reference item.
Slovenian: > 72 QF enot* *QF (Q-fever) enota: relativna potenca faze I antigena izmerjenega po ELISA testu v primerjavi z refrenčno enoto.
English: Under normal conditions the timing of vaccination should be planned so that the primary course is completed by 3 weeks before artificial insemination or mating.
Slovenian: V normalnih pogojih je potrebno čas cepljenja načrtovati tako, da je osnovno cepljenje končano 3 tedne pred umetno osemenitvijo ali pripustom.
English: Inactivated Coxiella burnetii, strain Nine Mile
Slovenian: Inaktivirana Coxiella burnetii, sev Nine Mile
English: Re-vaccination: One dose should be given yearly.
Slovenian: Revakcinacija: En odmerek letno.
English: For the active immunisation of cattle to lower the risk for non-infected animals vaccinated when nonpregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of Coxiella burnetii in these animals via milk and vaginal mucus.
Slovenian: Za aktivno zaščito goveda, za zmanjšanje tveganja pri neokuženih nebrejih cepljenih živalih, da bi postale prenašalci (5-krat manjša verjetnost v primerjavi z živalmi, ki prejemajo placebo) ter za zmanjšanje prenosa Coxiella burnetii pri teh živalih preko mleka in nožnične sluzi.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: Ni podatkov o varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: Duration of immunity: 280 days after completion of the primary vaccination course.
Slovenian: Trajanje imunosti: 280 dni po končanem osnovnem cepljenju.
English: The biological significance of the levels of reduction shown in shedding in cattle and goats is not known.
Slovenian: Biološki pomen stopnje znižanja klicenoštva pri govedu in kozah ni znan.
English: Two doses should be given subcutaneously with an interval of 3 weeks.
Slovenian: Dva odmerka subkutano v razmaku 3 tednov.
English: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Water for injections
Slovenian: Seznam pomožnih snovi tiomersal natrijev klorid natrijev hidrogenfosfat kalijev dihidrogenfosfat voda za injekcije
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi ,ki nastanejo pri uporabi teh zdravil
English: Inactivated Coxiella burnetii, strain Nine Mile > 72 QF Units/ml
Slovenian: Inaktivirana Coxiella burnetii, sev Nine Mile > 72 QF Enot / ml
English: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne FRANCE
Slovenian: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne Francija
English: 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.
Slovenian: 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.