FrancophonIA/ELRC3.0 huggingface dataset:
English: Why has Jevtana been approved?
Slovenian: Zakaj je bilo zdravilo Jevtana odobreno?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jevtana 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 zdravila Jevtana upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
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 Jevtana.
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 doses should also be reduced in patients with mildly or moderately reduced liver function.
Slovenian: Odmerek zdravila je treba zmanjšati tudi pri bolnikih z lažjo ali zmerno okvaro jeter.
English: Both medicines were given in combination with prednisone or prednisolone.
Slovenian: Obe zdravili so dajali v kombinaciji z prednizonom ali prednizolonom.
English: What is Jevtana and what is it used for?
Slovenian: Kaj je zdravilo Jevtana in za kaj se uporablja?
English: Other information about Jevtana
Slovenian: Druge informacije o zdravilu Jevtana
English: Jevtana also affects non-cancer cells, such as blood and nerve cells, which can cause side effects.
Slovenian: Zdravilo učinkuje tudi na nerakave celice, kot so krvne ali živčne celice, kar lahko povzroči neželene učinke.
English: Jevtana is used when the cancer has spread to other parts of the body (metastatic) despite treatments to prevent the production of testosterone or after surgical removal of the testes (castration).
Slovenian: Zdravilo Jevtana se uporablja, kadar se je rak razširil na druge dele telesa (metastaziral) kljub zdravljenjem za zaviranje tvorjenja testosterona ali po kirurški odstranitvi mod (kastraciji).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the ability of Jevtana to prolong overall survival in castration-resistant metastatic prostate cancer patients was clinically important.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je menil, da je učinkovitost zdravila Jevtana pri celokupnem podaljšanju preživetja bolnikov z metastatskim, proti kastraciji odpornim rakom prostate klinično pomembna.
English: Jevtana can only be obtained with a prescription and should only be used in units specialising in chemotherapy (medicines to treat cancer) under the supervision of a doctor experienced in the use of chemotherapy.
Slovenian: Predpisovanje in izdaja zdravila Jevtana je le na recept, uporabljati pa se sme samo v enotah, specializiranih za kemoterapijo (zdravila za zdravljenje raka), pod nadzorom zdravnika, ki ima izkušnje z uporabo tovrstnega zdravljenja.
English: Jevtana must not be used in people who are hypersensitive (allergic) to cabazitaxel, to any other taxane, or to any of the other ingredients.
Slovenian: Zdravila ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) kabazitaksel, na kateri koli drugi taksan ali katero koli drugo sestavino zdravila.
English: Jevtana is used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine).
Slovenian: Uporablja se v kombinaciji s prednizonom ali prednizolonom (protivnetnima zdraviloma) pri bolnikih, ki so se že zdravili z docetakselom (drugim zdravilom za zdravljenje raka).
English: The active substance in Jevtana, cabazitaxel, belongs to the group of cancer medicines known as ‘taxanes'.
Slovenian: Zdravilna učinkovina zdravila Jevtana, kabazitaksel, spada v skupino zdravil proti raku, ki so znana kot taksani.
English: The effects of Jevtana were compared with another cancer medicine, mitoxantrone.
Slovenian: Učinke zdravila Jevtana so primerjali z učinki drugega zdravila za zdravljenje raka, mitoksantrona.
English: How is Jevtana used?
Slovenian: Kako se zdravilo Jevtana uporablja?
English: For the full list of all side effects reported with Jevtana, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Jevtana, glejte navodilo za uporabo.
English: Jevtana is available as a concentrate and a solvent to be made up into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Jevtana je na voljo v obliki koncentrata in vehikla za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: Jevtana is a cancer medicine used to treat men with metastatic castration-resistant prostate cancer.
Slovenian: Jevtana je zdravilo proti raku, ki se uporablja za zdravljenje dveh vrst metastatskega, proti kastraciji odpornega raka prostate.
English: For more information, see the package leaflet.
Slovenian: Več informacij je na voljo v navodilu za uporabo.
English: How does Jevtana work?
Slovenian: Kako zdravilo Jevtana deluje?
English: Jevtana prolonged overall survival (the average length of time the patients lived) in one main study involving 755 men with metastatic castration-resistant prostate cancer who had previously been treated with docetaxel.
Slovenian: V eni glavni študiji pri 755 moških z metastatskim, proti kastraciji odpornim rakom prostate, ki so se prej zdravili z docetakselom, je zdravilo Jevtana podaljšalo celokupno preživetje (povprečen čas, ko je bolnik živel).
English: Jevtana contains the active substance cabazitaxel.
Slovenian: Zdravilo Jevtana vsebuje zdravilno učinkovino kabazitaksel.
English: The dose of Jevtana should be reduced or treatment stopped if the patient has certain side effects.
Slovenian: Če se pri bolniku pojavijo določeni neželeni učinki, je treba odmerek zdravila Jevtana zmanjšati ali zdravljenje prekiniti.
English: monograph 0063.
Slovenian: monografiji 0063.
English: * PD50- 50% protective dose in cattle as described in Ph. Eur.
Slovenian: * ZO50 - 50% zaščitni odmerek za govedo, kot je predpisano v Ph. Eur.
English: A24 Cruzeiro and A Turkey 14/98 ≥ 6 PD50*
Slovenian: A24 Cruzeiro in A Turkey 14/98 ≥ 6 PD50*
English: A22 Iraq, Asai1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: A22 Iraq, Asai1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: A24 Cruzeiro, Asia 1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: A24 Cruzeiro, Asia 1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: A Turkey 14/98, Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: A Turkey 14/98, Asia1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O Taiwan 3/97, A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: A24 Cruzeiro, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: A24 Cruzeiro, A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97 and A Turkey 14/98 ≥ 6 PD50*
Slovenian: O Taiwan 3/97 in A Turkey 14/98 ≥ 6 PD50*
English: SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: Saudi Arabia ≥ 6 PD50*
English: A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
Slovenian: A22 Iraq in A24 Cruzeiro ≥ 6 PD50*
English: A Turkey 14/98 and Asia 1 Shamir ≥ 6 PD50*
Slovenian: A Turkey 14/98 in Asia 1 Shamir ≥ 6 PD50*
English: O Taiwan 3/97, A24 Cruzeiro and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O Taiwan 3/97, A24 Cruzeiro & SAT2 Saudi Arabia ≥ 6 PD50*
English: A22 Iraq, A24 Cruzeiro and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: A22 Iraq, A24 Cruzeiro & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, O1 BFS and O Taiwan 3/97 ≥ 6 PD50*
Slovenian: O1 Manisa and O1 BFS in O Taiwan 3/97 ≥ 6 PD50*
English: A22 Iraq and Asia1 Shamir ≥ 6 PD50*
Slovenian: A22 Iraq in Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa and O1 BFS ≥ 6 PD50*
Slovenian: O1 Manisa in O1 BFS ≥ 6 PD50*
English: O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
Slovenian: O Taiwan 3/97 in A22 Iraq ≥ 6 PD50*
English: O Taiwan 3/97 and A24 Cruzeiro ≥ 6 PD50*
Slovenian: O Taiwan 3/97 in A24 Cruzeiro ≥ 6 PD50*
English: O1 BFS, A22 Iraq and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O1 BFS, A22 Iraq & SAT2 Saudi Arabia ≥ 6 PD50*
English: A24 Cruzeiro and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: A24 Cruzeiro & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97, Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O Taiwan 3/97, Asia1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa and A22 Iraq ≥ 6 PD50*
Slovenian: O1 Manisa in A22 Iraq ≥ 6 PD50*
English: O1 Manisa, A24 Cruzeiro and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O1 Manisa, A24 Cruzeiro & SAT2 Saudi Arabia ≥ 6 PD50*
English: A24 Cruzeiro and Asia 1 Shamir ≥ 6 PD50*
Slovenian: A24 Cruzeiro in Asia 1 Shamir ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and A Turkey 14/98 ≥ 6 PD50*
Slovenian: O1 BFS in O Taiwan 3/97 in A Turkey 14/98 ≥ 6 PD50*
English: O1 BFS, Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O1 BFS, Asia1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O1 Manisa, Asia1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa and A24 Cruzeiro ≥ 6 PD50*
Slovenian: O1 Manisa in A24 Cruzeiro ≥ 6 PD50*
English: O1 Manisa, O1 BFS and A 24 Cruzeiro ≥ 6 PD50*
Slovenian: O1 Manisa and O1 BFS in A 24 Cruzeiro ≥ 6 PD50*
English: A24 Cruzeiro, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Slovenian: A24 Cruzeiro in A Turkey 14/98 in Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O1 Manisa & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O1 BFS, O Taiwan 3/97 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 BFS, A24 Cruzeiro and A Turkey 14/98 ≥ 6 PD50*
Slovenian: O1 BFS in A24 Cruzeiro in A Turkey 14/98 ≥ 6 PD50*
English: O1 BFS and A24 Cruzeiro ≥ 6 PD50*
Slovenian: O1 BFS in A24 Cruzeiro ≥ 6 PD50*
English: O1 Manisa, O Taiwan 3/97 and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O1 Manisa, O Taiwan 3/97 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97 and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O Taiwan 3/97 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O1 Manisa, A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 BFS and A22 Iraq ≥ 6 PD50*
Slovenian: O1 BFS in A22 Iraq ≥ 6 PD50*
English: O1 BFS, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O1 BFS, A Turkey 14/98 & SAT2Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, A24 Cruzeiro and A Turkey 14/98 ≥ 6 PD50*
Slovenian: O1 Manisa in A24 Cruzeiro in A Turkey 14/98 ≥ 6 PD50*
English: O Taiwan 3/97 and Asia1 Shamir ≥ 6 PD50*
Slovenian: O Taiwan 3/97 in Asia1 Shamir ≥ 6 PD50*
English: O Taiwan 3/97, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Slovenian: O Taiwan 3/97 in A Turkey 14/98 in Asia1 Shamir ≥ 6 PD50*
English: O1 BFS and SAT2 Saudi Arabia ≥ 6 PD50*
Slovenian: O1 BFS & SAT2 Saudi Arabia ≥ 6 PD50*
English: A22 Iraq, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50*
Slovenian: A22 Iraq in A24 Cruzeiro in Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa, O Taiwan 3/97 and A24 Cruzeiro ≥ 6 PD50*
Slovenian: O1 Manisa in O Taiwan 3/97 in A24 Cruzeiro ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and A24 Cruzeiro ≥ 6 PD50*
Slovenian: O1 BFS in O Taiwan 3/97 in A24 Cruzeiro ≥ 6 PD50*
English: O Taiwan 3/97, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50*
Slovenian: O Taiwan 3/97 in A24 Cruzeiro in Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa, O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
Slovenian: O1 Manisa in O Taiwan 3/97 in A22 Iraq ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
Slovenian: O1 BFS in O Taiwan 3/97 in A22 Iraq ≥ 6 PD50*
English: O1 Manisa, O Taiwan 3/97 and Asia1 Shamir ≥ 6 PD50*
Slovenian: O1 Manisa in O Taiwan 3/97 in Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and Asia1 Shamir ≥ 6 PD50*
Slovenian: O1 BFS in O Taiwan 3/97 in Asia1 Shamir ≥ 6 PD50*
English: O Taiwan 3/97, A22 Iraq and Asia1 Shamir ≥ 6 PD50*
Slovenian: O Taiwan 3/97 in A22 Iraq in Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, A22 Iraq and Asia1 Shamir ≥ 6 PD50*
Slovenian: O1 BFS in A22 Iraq in Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Slovenian: O1 BFS in A Turkey 14/98 in Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Slovenian: O1 Manisa in A Turkey 14/98 in Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
Slovenian: O1 BFS in A22 Iraq in A24 Cruzeiro ≥ 6 PD50*
English: O1 BFS and Asia1 Shamir ≥ 6 PD50*
Slovenian: O1 BFS in Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50*
Slovenian: O1 Manisa in A24 Cruzeiro in Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa and Asia1 Shamir ≥ 6 PD50*
Slovenian: O1 Manisa in Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50*
Slovenian: O1 BFS in A24 Cruzeiro in Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa, O1 BFS and Asia1 Shamir ≥ 6 PD50*
Slovenian: O1 Manisa and O1 BFS in Asia1 Shamir ≥ 6 PD50*
English: O Taiwan 3/97, A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
Slovenian: O Taiwan 3/97 in A22 Iraq in A24 Cruzeiro ≥ 6 PD50*
English: O1 BFS and O Taiwan ≥ 6 PD50*
Slovenian: O1 BFS in O Taiwan 3/97 ≥ 6 PD50*
English: O1 Manisa and O Taiwan ≥ 6 PD50*
Slovenian: O1 Manisa in O Taiwan 3/97 ≥ 6 PD50*
English: O1 Manisa and A Turkey ≥ 6 PD50*
Slovenian: O1 Manisa in A Turkey 14/98 ≥ 6 PD50*
English: O1 BFS and A Turkey ≥ 6 PD50*
Slovenian: O1 BFS in A Turkey 14/98 ≥ 6 PD50*
English: In the general safety analyses, no specific safety concerns were identified.
Slovenian: V splošnih analizah varnosti niso odkrili nobenih posebnih skrbi glede varnosti.
English: From 6 weeks to 32 weeks
Slovenian: Od 6 do 32 tednov
English: The following information is intended for health care professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju:
English: Date of first authorisation: 27 June 2006
Slovenian: Datum prve odobritve: 27. junij 2006
English: The results of these analyses are presented in the following tables.
Slovenian: Rezultati teh analiz so predstavljeni v tabelah v nadaljevanju.
English: Store in a refrigerator (2 °C to 8 °C).
Slovenian: Shranjujte v hladilniku (2 °C do 8 °C).
English: Effectiveness % [95%CI]
Slovenian: Učinkovitost % [95 % IZ]
English: Date of latest renewal: 18 May 2011
Slovenian: Datum zadnjega podaljšanja: 18. maj 2011
English: 4.8 Undesirable effects a. Summary of the safety profile
Slovenian: 4.8 Neželeni učinki a. Povzetek varnostnega profila cepiva
English: There was an extension of REST conducted in Finland only.
Slovenian: Študija REST je bila podaljšana le na Finskem.
English: Statistically significant
Slovenian: statistično pomembno
English: See sections 4.2 and 5.1.
Slovenian: Glejte poglavji 4.2. in 5.1.
English: Clinical trials of efficacy against rotavirus gastroenteritis were performed in Europe, the United States, Latin America, and Asia.
Slovenian: Klinična preskušanja učinkovitosti proti rotavirusnemu gastroenteritisu so bila izvedena v Evropi, Združenih državah, Latinski Ameriki in Aziji.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Slovenian: Ker je korist cepljenja v tej skupini otrok velika, se cepljenja ne sme odložiti ali opustiti.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Slovenian: Blaga okužba, kot je prehlad, ni ovira, vendar se prej posvetujte z zdravnikom.
English: Parents/guardians should be advised to promptly report such symptoms to their healthcare provider.
Slovenian: Staršem/spremljevalcem je treba svetovati, da o teh simptomih takoj poročajo zdravstvenemu osebju.
English: Study population
Slovenian: Preučevana populacija
English: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data)
Slovenian: Pogostnost je označena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1.000, < 1/100); redki (≥ 1/10.000, < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: The dose administered to mice was approximately 2.79 x 10
Slovenian: Odmerek, ki so ga dali mišim, je bil približno 2,79 x 10
English: The frequency category was estimated based on observational study data.
Slovenian: Kategorija pogostnosti je bila ocenjena na podlagi podatkov iz opazovalnih študij.
English: This may present as wheezing, coughing or difficulty breathing.
Slovenian: To se lahko kaže kot piskanje, kašelj ali težave pri dihanju.
English: The requirements for submission of periodic safety update reports 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: RV seasons
Slovenian: RV sezone
English: *RV-negative acute gastroenteritis controls
Slovenian: *RV-negativne kontrole akutnega gastroenteritisa
English: In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti, tega cepiva ne smemo mešati z drugimi zdravili.
English: • Not known (frequency cannot be estimated from the available data): irritability
Slovenian: • neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): razdražljivost
English: Telephone: Telefax:
Slovenian: Telefon: Faks:
English: The efficacy observed against G2P[4] most likely resulted from the G2 component of the vaccine.
Slovenian: Učinkovitost, ki so jo opazili proti G2P[4], je najverjetneje povzročila G2 komponenta cepiva.
English: - your child has any disease which reduces his/her resistance to infection.
Slovenian: - če ima katero koli bolezen, ki zmanjšuje njegovo odpornost proti okužbam.
English: Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines (or other vaccines).
Slovenian: Obvestite zdravnika ali farmacevta, če vaš otrok jemlje ali je pred kratkim jemal katero koli drugo zdravilo (ali cepivo).
English: 6 Infectious Units
Slovenian: 6 infektivnih enot
English: Cohort study (France)
Slovenian: Kohortna študija (Francija)
English: 8 infectious units per kg (about 14-fold the projected infant dose).
Slovenian: 8 infektivnih enot na kg (približno 14-kratni odmerek, ki je predviden za cepljenje otrok).
English: If necessary, the third (last) dose may be given up to the age of 32 weeks (see section 5.1).
Slovenian: Če je potrebno, se lahko s tretjim (zadnjim) odmerkom cepi do starosti 32 tednov (glejte poglavje 5.1).
English: - your child has a severe infection with a high temperature.
Slovenian: - če ima hudo okužbo z močno zvišano telesno temperaturo.
English: Adverse Reaction/Event
Slovenian: Neželeni učinek/dogodek
English: The background incidence of intussusception in infants less than one year of age in these countries ranged from 25 to 101 per 100,000 infants per year.
Slovenian: Osnovna pojavnost invaginacije v teh državah se je pri dojenčkih, mlajših od enega leta, gibala med 25 in 101 na 100.000 dojenčkov na leto.
English: The frequency category was estimated based on relevant clinical trials.
Slovenian: Kategorija pogostnosti je bila ocenjena na podlagi relevantnih kliničnih preskušanj.
English: Efficacy
Slovenian: Učinkovitost
English: Overall, 31 % and 25 % of the encounters in the respective groups occurred during the FES.
Slovenian: V celoti gledano se je 31 % oz. 25 % obiskov zdravnika v posamezni skupini pojavilo tekom FES.
English: • Allergic reactions (frequency cannot be estimated from the available data), which may be severe (anaphylaxis), and may include: allergic swelling that may affect the face, lips, tongue or throat.
Slovenian: • Alergijske reakcije (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti), ki so lahko hude (anafilaksija), in lahko vključujejo: alergijsko oteklino, ki se lahko pojavi na obrazu, ustnicah, jeziku ali žrelu.
English: Claims database analysis (US)
Slovenian: Analiza baze podatkov (ZDA)
English: 1 dose (2 ml)
Slovenian: 1 odmerek (2 ml)
English: One dose (2 ml) contains:
Slovenian: En odmerek (2 ml) vsebuje:
English: During the 0-30 day follow-up period after vaccination, there were no statistically significant difference in the rate of Kawasaki disease compared with the expected background rate.
Slovenian: V obdobju spremljanja 0-30 dni po cepljenju ni bilo statistično značilne razlike v deležu Kawasakijeve bolezni v primerjavi s pričakovanim deležem za to populacijo.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Study design (Region)
Slovenian: Načrt študije (regija)
English: Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza-izomaltaze ne smejo prejeti tega cepiva.
English: Intussusception α *
Slovenian: Invaginacija α *
English: Effectiveness study data Post marketing studies demonstrating effectiveness to prevent RV gastroenteritis (RVGE)
Slovenian: Rezultati študije učinkovitosti Študije v obdobju trženja, ki prikazujejo učinkovitost za preprečevanje RV gastroenteritisa (RVGE)
English: If the problem recurs, additional replacement doses should not be given.
Slovenian: Če se to še ponovi, mu dodatnega nadomestnega odmerka ne smete dati.
English: Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa cepiva in zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh.
English: These infants should receive the first dose of vaccine between 6 and 12 weeks after birth.
Slovenian: Ti dojenčki morajo prejeti prvi odmerek cepiva med 6. in 12. tednom po rojstvu.
English: Excipient with known effect: This vaccine contains 1080 mg sucrose (see section 4.4).
Slovenian: Pomožna snov z znanim učinkom: Cepivo vsebuje 1080 mg saharoze (glejte poglavje 4.4).
English: There should be intervals of at least 4 weeks between doses.
Slovenian: Med posameznima odmerkoma morajo miniti vsaj 4 tedni.
English: RotaTeq is to be used on the basis of official recommendations.
Slovenian: Cepivo RotaTeq je treba uporabljati na podlagi uradnih priporočil.
English: * See section 4.4.
Slovenian: * Glejte poglavje 4.4.
English: These infants should receive the first dose of RotaTeq at least six weeks after birth (see sections 4.4 and 5.1).
Slovenian: Ti otroci morajo prvi odmerek cepiva RotaTeq prejeti najmanj 6 tednov po rojstvu (glejte poglavji 4.4 in 5.1).
English: When an infant is given the vaccine, the immune system (the body's natural defences) will make antibodies against the most commonly occurring types of rotavirus.
Slovenian: Ko dojenček prejme cepivo, imunski sistem (naravna obramba telesa) proizvede protitelesa proti najpogostejšim tipom rotavirusov.
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine ATC code: J07BH02.
Slovenian: Farmakoterapevtska skupina: Cepiva, virusna cepiva, oznaka ATC: J07BH02
English: Telephone:
Slovenian: Telefon: