FrancophonIA/ELRC3.0 huggingface dataset:
English: Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names are tablets for dogs containing praziquantel, pyrantel embonate and febantel and indicated for various parasitic infections.
Slovenian: Zdravila Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus in z njimi povezana imena so tablete za pse in vsebujejo prazikvantel, pirantel embonat in febantel ter so inducirana za različne okužbe s paraziti.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI
English: 150, 180, 200, 204, 206, 250, 280, 300, 500 or 1000 tablets.
Slovenian: 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 in 1000 tablet
English: Do not exceed the stated dose when treating pregnant bitches.
Slovenian: Pri zdravljenju brejih psic ne prekoračite določenega odmerka.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years Discard any unused divided tablets.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta.
English: In the interests of good hygiene, persons administering the tablets directly to a dog or adding them to the dog's food should wash their hands afterwards.
Slovenian: Oseba, ki daje psu zdravilo direktno ali dodano v hrani, naj poskrbi za higieno in si umije roke.
English: The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus (Bayer Animal Health).
Slovenian: Gre za sedem vzporednih zdravil z enakimi dokumentacijami za vlogo za hibridna zdravila in z referenčnim zdravilom Drontal Plus (Bayer Animal Health).
English: To be completed nationally.
Slovenian: Podatke je treba dopolniti.
English: Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative In this fixed combination, pyrantel and febantel act against all relevant nematodes (ascarids, hookworms, and whipworms) in dogs.
Slovenian: 2. pirantelembonat (pamoat), derivat tetrahidropirimidina 3. prazikvantel, derivat delno hidrogeniziranega pirazinoizokvinolina V navedeni kombinaciji delujeta pirantel in febantel proti vsem pomembnim nematodom (askaridom, ankilostomidom in bičeglavcem) pri psih.
English: Evaluation of the benefit - risk balance
Slovenian: Ocena razmerja med koristmi in tveganji
English: In conclusion, based on the totality of data presented, it is accepted that the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names) will be effective (up to 100%) in the treatment of immature and mature forms of E. granulosus and E. multilocularis in the dog.
Slovenian: Za zaključek je bilo na podlagi celokupnih predstavljenih podatkov sprejeto, da je zadevno zdravilo (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus in Prazitel Plus in z njimi povezana imena) učinkovito (do 100 %) pri zdravljenju nezrelih in zrelih oblik E. granulosus in E. multilocularis pri psih.
English: 50mg (equivalent to 144 mg pyrantel embonate)
Slovenian: 50 mg (ekvivalentno 144 mg pirantelembonata)
English: Appropriate user safety advice is included in the product literature.
Slovenian: Strokovna literatura o zdravilu vključuje ustrezna varnostna navodila.
English: • the CVMP considered the primary scope of the referral regarding efficacy against Echinococcus granulosus and Echinococcus multilocularis;
Slovenian: • obravnaval primarni namen napotitve v zvezi z učinkovitostjo proti Echinococcus granulosus in Echinococcus multilocularis,
English: In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum and Trichuris vulpis.
Slovenian: Spekter delovanja zajame predvsem Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum in Trichuris vulpis.
English: The in vivo data are further supported by the results of the comparative dissolution profiles of the concerned product with the reference product Drontal Plus tablets.
Slovenian: Podatke in vivo so potrdili tudi rezultati primerjalnih profilov raztapljanja zadevnega zdravila in referenčnega zdravila, tablet Drontal Plus.
English: Chanelle Pharmaceuticals Manufacturing Ltd.
Slovenian: Velika Britanija Chanelle Pharmaceuticals Manufacturing Ltd.
English: Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults).
Slovenian: Kavljasti črvi: Uncinaria stenocephala, Ancylostoma caninum (odrasle oblike).
English: Tapeworms: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).
Slovenian: Trakulje: Echinococcus species, (E. granulosus, E. multilocularis), Taenia spp., (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (odrasli in nerazvite oblike).
English: Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms).
Slovenian: Askaridi: Toxocara canis, Toxascaris leonina (odrasle in razvojne oblike).
English: In case of accidental ingestion, seek medical advice and show the package leaflet to the physician.
Slovenian: V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo.
English: Only traces of non-metabolised praziquantel are excreted.
Slovenian: Nemetaboliziran prezikvantel se izloči le v sledeh.
English: Chanelle Pharmaceuticals Manufacturing Ltd.has extrapolated the efficacy data available in the public domain for the Bayer Animal Health products (Droncit and Drontal Plus) to the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names) by presenting a comparative pharmacokinetic study conducted with the concerned product and Drontal Plus (Bayer Aniamal Health).
Slovenian: Družba Chanelle Pharmaceuticals Manufacturing Ltd. je javno dostopne podatke o učinkovitosti za izdelke družbe Bayer Animal Health (Droncit in Drontal Plus) prenesla na zadevno zdravilo (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus in Prazitel Plus in z njimi povezana imena), tako da je predložila primerjalno farmakokinetično študijo o zadevnem zdravilu in zdravilu Drontal Plus (Bayer Animal Health).
English: This is equivalent to 1 tablet per 10 kg (22 lbs) bodyweight.
Slovenian: Navedeno je enako 1 tableti na 10 kg (22 lbs) telesne teže.
English: ANNEX I:
Slovenian: Priloga I
English: The combination of praziquantel, pyrantel embonate and febantel is well tolerated in dogs.
Slovenian: Psi kombinacijo prazikvantela, pirantelembonata in febantela dobro prenašajo.
English: MARKETING AUTHORISATION HOLDER Chanelle Pharmaceuticals Manufacturing Limited, Loughrea,
Slovenian: Chanelle Pharmaceuticals Manufacturing Limited, Loughrea,
English: Overall summary of the scientific evaluation of Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names (see annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus in z njimi povezanih imen (glejte Prilogo I)
English: {CARTON FOR PACK SIZES OF 10 TABLETS, AND UPWARDS}
Slovenian: Škatla za 10 tablet in več
English: The SPCs for these four products does not include indications against Echinococcus granulosus and Echinococcus multilocularis.
Slovenian: Povzetki glavnih značilnosti za ta štiri zdravila ne vsebujejo indikacij proti Echinococcus granulosus in Echinococcus multilocularis.
English: Therefore the CVMP has recommended the variation of the marketing authorisations for which the summaries of product characteristics, labelling and package leaflet are set out in Annex III for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, and associated names, authorised by MRP IE/V/0272-0275/001/MR involving Ireland as reference Member State and France as concerned Member State (see Annex I).
Slovenian: Zato je Odbor CVMP priporočil spremembo dovoljenj za promet z zdravilom, katerih povzetki glavnih značilnosti zdravila, označevanje in navodilo za uporabo so v Prilogi III, in sicer za zdravila Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus in z njimi povezana imena, ki so dobila dovoljenje po postopku z medsebojnim priznavanjem IE/V/0272-0275/001/MR, pri čemer je bila Irska referenčna država članica in Francija zadevna država članica (glejte Prilogo I).
English: {CARTON FOR PACK SIZES OF 2, 4, 6 AND 8 TABLETS}
Slovenian: Škatla za 2, 4, 6 in 8 tablet
English: Milaxyn Plus, Strantel Plus, Prazical Plus and Voxical Plus were authorised subsequently by MRP IE/V/0272-0275/001/MR as hybrid applications under Article 13(3) of Directive 2001/82/EC, as amended involving Ireland as reference Member State and France as concerned Member State.
Slovenian: Zdravila Milaxyn Plus, Strantel Plus, Prazical Plus in Voxical Plus so naknadno dobila dovoljenje po postopku z medsebojnim priznavanjem IE/V/0272-0275/001/MR kot vloge za hibridna zdravila, v skladu s členom 13 (3) Direktive 2001/82/ES z vsemi spremembami, pri čemer je bila Irska referenčna država članica in Francija zadevna država članica.
English: 4.4 Special warnings for each target species
Slovenian: Posebna opozorila <za vsako ciljno živalsko vrsto>
English: The indication for the treatment of immature and mature forms of E. granulosus and E. multilocularis can be accepted for the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names).
Slovenian: Indikacijo za zdravljenje nezrelih in zrelih oblik E. granulosus in E. multilocularis se lahko sprejme za zadevno zdravilo (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus in Prazitel Plus ter z njimi povezana imena).
English: the CVMP, concluded that the overall benefit/risk balance for these products remains positive subject to the recommended changes in the product information for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, and associated names, authorised by MRP IE/V/0272-0275/001/MR involving Ireland as reference Member State and France as concerned Member State.
Slovenian: in zaključil, da je splošno razmerje med koristmi in tveganji za ta zdravila še vedno pozitivno, ob upoštevanju priporočenih sprememb v informacijah o zdravilu za zdravila Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus in z njimi povezana imena, ki so dobila dovoljenje po postopku z medsebojnim priznavanjem IE/V/0272-0275/001/MR, pri čemer je bila Irska referenčna država članica in Francija zadevna država članica.
English: The recommended dose rates are: 15 mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to 14.4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel.
Slovenian: Priporočen odmerek je: 15 mg/kg telesne teže febantela, 5 mg/kg pirantela (ekvivalentno 14,4 mg/kg pirantelembonata) in 5 mg/kg prazikvantela.
English: Please refer to package leaflet for disposal advice.
Slovenian: Navodila o odstranjevanju preberite v navodilu za uporabo.
English: 1 tablet per 10 kg (22 lbs) bodyweight.
Slovenian: 1 tableta na 10 kg (22 lbs) telesne teže.
English: The SPC for these three products includes indications against Echinococcus granulosus and Echinococcus multilocularis.
Slovenian: Povzetek glavnih značilnosti za ta tri zdravila vsebuje indikacije proti Echinococcus granulosus in Echinococcus multilocularis.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
English: The marketing authorisation holder for the concerned product is Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus, Exitel Plus, Cazitel Plus and associated names were authorised in many Member States (EU/EEA) by mutual recognition procedure (MRP) IE/V/0241-0243/001/MR as duplicate hybrid applications under Article 13(3) of Directive 2001/82/EC as amended.
Slovenian: Zdravila Prazitel Plus, Exitel Plus, Cazitel Plus in z njimi povezana imena so v številnih državah članicah (EU/EGP) pridobila dovoljenje za promet po postopku z medsebojnim priznavanjem (MRP) IE/V/02410243/001/MR kot vzporedne vloge za hibridna zdravila v skladu s členom 13 (3) Direktive 2001/82/ES z vsemi spremembami.
English: 1 tablet per 10 kg bodyweight.
Slovenian: 1 tableta na 10 kg telesne teže.
English: For Animal Treatment Only.
Slovenian: Samo za živali.
English: The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus.
Slovenian: Gre za sedem vzporednih zdravil z enako dokumentacijo za vlogo za hibridna zdravila in z referenčnim zdravilom Drontal Plus.
English: In dogs: Treatment of mixed infections by nematodes and cestodes of the following species Nematodes:
Slovenian: Psi: zdravljenje mešanih infekcij z nematodi in cestodi sledečih vrst: Nematodi:
English: These data are adequate as a bridge between the documented efficacy of the reference product (Drontal Plus) and the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names).
Slovenian: Ti podatki so primerni za povezavo med dokumentirano učinkovitostjo referenčnega zdravila (Drontal Plus) in zadevnega zdravila (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus in Prazitel Plus in z njimi povezana imena).
English: This product contains anthelmintics active against gastrointestinal roundworms and tapeworms.
Slovenian: Zdravilo vsebuje zdravilne učinkovine, ki učinkujejo na želodčno črevesne valjaste črve in trakulje.
English: For oral administration.
Slovenian: Peroralna uporaba.
English: 50 mg/tablet Praziquantel, 50 mg/tablet Pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg/tablet Febantel.
Slovenian: 50 mg/tableto prazikvantela, 50 mg/tableto pirantela (ekvivalentno 144 mg pirantelembonata) in 150 mg/ tableto febantela
English: 1 pork flavoured tablet contains 50 mg Praziquantel, 50 mg Pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg Febantel.
Slovenian: 1 tableta z okusom svinjine vsebuje: 50 mg prazikvantela, 50 mg pirantela (ekvivalentno 144 mg pirantelembonata) in 150 mg febantela
English: Pork flavoured tablets.
Slovenian: Tableta z okusom svinjine
English: Dosage table: Bodyweight (kg)
Slovenian: Telesna teža (kg)
English: Each tablet contains: Active substances: Praziquantel
Slovenian: Zdravilne učinkovine: Prazikvantel
English: User Precautions:
Slovenian: Tabela z odmerki:
English: Not Applicable
Slovenian: NEŽELENI UČINKI
English: This veterinary medicinal product does not require any special storage conditions
Slovenian: Za shranjevanje ni posebnih navodil.
English: Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate)
Slovenian: Prazitel Plus Praziquantel 50 mg Pyrantel 50 mg (ekvivalentno 144 mg pyrantel embonate) Febantel 150 mg
English: For animal treatment only.
Slovenian: Samo za živali
English: The product is presented in either:
Slovenian: Zdravilo je pakirano kot:
English: {BLISTER FOIL TEXT}
Slovenian: Serija{številka}
English: The product is well tolerated in the target species.
Slovenian: Ciljna vrsta zdravilo dobro prenaša.
English: Section 3.
Slovenian: Poglavje 3.
English: How to use <Invented Name>?
Slovenian: Kako uporabljati zdravilo <izmišljeno ime>?
English: Annex III Amendments to relevant sections of the product information
Slovenian: Priloga III Spremembe zadevnih poglavij informacij o zdravilu
English: Amendments to relevant sections of the product information of methadone tablets containing low molecular weight povidone (K25 or K30)
Slovenian: Spremembe zadevnih poglavij informacij o zdravilu za tablete, ki vsebujejo metadon in povidon z majhno relativno molekulsko maso (K25 ali K30)
English: Section 6.1 List of excipients [Information about the type of povidone, e.g. K25 or K30, should be included in this section.]
Slovenian: Seznam pomožnih snovi [V to poglavje je treba vključiti informacije o vrsti povidona - npr. K25 ali K30.]
English: [The following text should be included in this section] This product is for oral use only, and must not be injected.
Slovenian: To zdravilo je namenjeno samo za peroralno uporabo in se ne sme injicirati.
English: Section 4.2 Posology and method of administration [The following text should be included in this section] This product is for oral use only, and must not be injected.
Slovenian: A. Povzetek glavnih značilnosti zdravila Poglavje 4.2 Odmerjanje in način uporabe [V to poglavje je treba vključiti besedilo v nadaljevanju.]
English: The potential risk for pregnant women is unknown.
Slovenian: Morebitno tveganje za nosečnice ni znano.
English: May 2017
Slovenian: 24. maj 2017
English: The use of this vaccine should be in accordance with official recommendations.
Slovenian: To cepivo je treba uporabljati v skladu z uradnimi priporočili.
English: Do not use the vaccine if it cannot be re-suspended.
Slovenian: Cepiva ne uporabite, če ga ne morete ponovno suspendirati.
English: Individuals 10 years and older
Slovenian: Posamezniki, stari 10 let in več
English: • have a severe infection with a high fever.
Slovenian: • imate hudo okužbo z visoko vročino.
English: Because this reaction was derived from spontaneous reports, the frequency could not be determined and is thus considered as not known.
Slovenian: Ker ta učinek izvira iz spontanih poročil, pogostnosti ni mogoče določiti in je torej opredeljena kot neznana.
English: Other ingredients:
Slovenian: Druge sestavine:
English: Other paediatric population
Slovenian: Druga pediatrična populacija
English: Store in a refrigerator (2 °C-8 °C).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C).
English: In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo spremljanje življenjskih funkcij in morebitno simptomatsko zdravljenje.
English: Results from Groups 2 and 3 are not presented, as only 2 representative strains were evaluated.
Slovenian: Rezultati iz Skupin 2 in 3 niso predstavljeni, saj so ocenili samo 2 reprezentativna seva.
English: The vaccine contains two important components from the surface of the bacteria.
Slovenian: Cepivo vsebuje dve pomembni sestavini s površine bakterij.
English: The vaccine works by helping the body to make antibodies (the body's natural defences) which protect you or your child against this disease.
Slovenian: Cepivo deluje tako, da telesu pomaga pri tvorbi protiteles (naravna obramba telesa), ki vas ali vašega otroka ščitijo pred boleznijo.
English: However, some of the side effects mentioned under section 4 ‘Possible side effects' may temporarily affect you.
Slovenian: Vendar lahko nekateri neželeni učinki, navedeni v poglavju 4 ''Možni neželeni učinki'', začasno vplivajo na vas.
English: If this is the case, then vaccination will be postponed.
Slovenian: V tem primeru bo treba cepljenje odložiti.
English: Not known (cannot be estimated from available data) - Allergic reactions
Slovenian: Neznani (ni mogoče oceniti iz razpoložljivih podatkov) - alergijske reakcije
English: For instructions on the handling of the vaccine before administration, see section 6.6.
Slovenian: Za navodila glede ravnanja s cepivom pred dajanjem glejte poglavje 6.6.
English: • have had any problems after any dose of Trumenba such as an allergic reaction or problems with breathing.
Slovenian: • ste kdaj imeli kakršnekoli težave po kateremkoli odmerku cepiva Trumenba, na primer alergijsko reakcijo ali težave z dihanjem.
English: Serum was obtained approximately 1 month after vaccination.
Slovenian: Serum so pridobili približno 1 mesec po cepljenju.
English: - This vaccine has been prescribed for you or your child only.
Slovenian: - Cepivo je bilo predpisano vam ali vašemu otroku osebno.
English: The requirements for submission of periodic safety update repots for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Pharmacotherapeutic group: vaccines; ATC code: J07AH09
Slovenian: Farmakoterapevtska skupina: cepiva, oznaka ATC: J07AH09
English: Experience of overdose is limited.
Slovenian: Izkušnje s prevelikim odmerjanjem so omejene.
English: Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection.
Slovenian: Vseeno cepljenja ne smemo odložiti, kadar obstaja jasno tveganje za izpostavljenost meningokokni okužbi.
English: If this occurs, wait until the effects wear off before driving or using machines.
Slovenian: Če se to zgodi, pred vožnjo ali upravljanjem strojev počakajte, da učinki izzvenijo.
English: The expiry date refers to the last day of that month.
Slovenian: Rok uporabnosti cepiva se izteče na zadnji dan navedenega meseca.
English: Vaccination should be postponed in individuals suffering from an acute severe febrile illness.
Slovenian: Cepljenje je treba odložiti pri posameznikih z akutno, hudo febrilno boleznijo.
English: Adverse reactions reported in clinical studies are listed in decreasing order of frequency and seriousness according to the following frequency categories:
Slovenian: Neželeni učinki, o katerih so poročali v kliničnih preskušanjih, so navedeni po padajoči pogostnosti in resnosti skladno z naslednjimi kategorijami pogostnosti:
English: Of the 1,713 subjects randomised, 427 were in Group 1, 430 were in Group 2, 427 were in Group 3, 286 were in Group 4, and 143 were in Group 5.
Slovenian: Od 1.713 preskušancev so jih 427 randomizirali v Skupino 1, 430 v Skupino 2, 427 v Skupino 3, 286 v Skupino 4 in 143 v Skupino 5.
English: However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.
Slovenian: Vendar lahko nekateri učinki, navedeni v poglavju 4.8, začasno vplivajo na sposobnost vožnje in upravljanja strojev.
English: Trumenba should not be given: - if you or your child are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Cepiva Trumenba ne smete prejeti: - če ste vi ali vaš otrok alergični na učinkovino ali katerokoli sestavino tega cepiva (navedeno v poglavju 6).
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility in females (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost samic (glejte poglavje 5.3).
English: Persistence of immunity and response to booster vaccination
Slovenian: Vztrajanje imunosti in odziva na obnovitveno cepljenje
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Trumenba is given.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete cepivo Trumenba.
English: Not known (cannot be estimated from available data)
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
English: Safety and efficacy of Trumenba in children below 10 years of age have not been established.
Slovenian: Varnost in učinkovitost cepiva Trumenba pri otrocih, mlajših od 10 let, nista bili dokazani.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Slovenian: Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake ''EXP''.
English: Time Point
Slovenian: Časovna točka