FrancophonIA/ELRC3.0 huggingface dataset:
English: The average overall survival for patients treated with Jevtana was 15.1 months compared with 12.7 months for patients given mitoxantrone.
Croatian: Prosječno ukupno preživljenje bolesnika liječenih lijekom Jevtana bilo je 15,1 mjesec, u usporedbi s 12,7 mjeseci u bolesnika koji su primali mitoksantron.
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.
Croatian: Jevtana se ne smije upotrebljavati kod osoba koje su preosjetljive (alergične) na kabazitaksel ili na neki drugi taksan ili bilo koji drugi sastojak.
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.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke za primjenu lijeka Jevtana.
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.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Jevtana nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: What are the risks associated with Jevtana?
Croatian: Koji su rizici povezani s lijekom Jevtana?
English: Jevtana also affects non-cancer cells, such as blood and nerve cells, which can cause side effects.
Croatian: Jevtana također djeluje na ostale stanice, poput krvnih i živčanih stanica, što može prouzročiti nuspojave.
English: Jevtana contains the active substance cabazitaxel.
Croatian: Jevtana sadrži djelatnu tvar kabazitaksel.
English: Both medicines were given in combination with prednisone or prednisolone.
Croatian: Oba lijeka davana su u kombinaciji s prednizonom ili prednizolonom.
English: For more information about treatment with Jevtana, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Jevtana pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: How is Jevtana used?
Croatian: Kako se Jevtana koristi?
English: Why has Jevtana been approved?
Croatian: Zašto je lijek Jevtana odobren?
English: Cabazitaxel works by blocking the ability of cancer cells to break down their internal ‘skeleton' that allows them to divide and multiply.
Croatian: Kabazitaksel djeluje inhibirajući sposobnost stanica raka da razgrađuju svoj unutarnji „kostur”, što im omogućuje diobu i razmnožavanje.
English: Before receiving Jevtana infusions, patients should first be given medicines to prevent allergic reactions and medicines to prevent vomiting.
Croatian: Prije infuzije lijeka Jevtana bolesnicima je potrebno dati lijekove za sprječavanje alergijskih reakcija i lijekove za sprječavanje povraćanja.
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).
Croatian: Jevtana se primjenjuje u slučaju kad se rak proširio (metastazirao) na ostale dijelove tijela unatoč terapijama za sprječavanje stvaranja testosterona ili nakon kirurškog odstranjenja testisa (kastracije).
English: The dose of Jevtana should be reduced or treatment stopped if the patient has certain side effects.
Croatian: Dozu lijeka Jevtana treba smanjiti odnosno liječenje treba prekinuti ako se kod bolesnika pojave određene nuspojave.
English: The effects of Jevtana were compared with another cancer medicine, mitoxantrone.
Croatian: Učinci lijeka Jevtana uspoređeni su s drugim lijekom protiv raka, mitoksantronom.
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.
Croatian: Lijekom Jevtana produženo je ukupno preživljenje (prosječno vrijeme koje su bolesnici preživjeli) u jednom glavnom ispitivanju koje je obuhvatilo 755 muškaraca s metastatskim rakom prostate otpornim na kastraciju koji su prethodno bili liječeni docetakselom.
English: Other information about Jevtana
Croatian: Ostale informacije o lijeku Jevtana
English: This is cancer that affects the prostate gland in men that produces the liquid in semen.
Croatian: Radi se o raku koji zahvaća prostatu i stvara tekućinu u sjemenu.
English: The doses should also be reduced in patients with mildly or moderately reduced liver function.
Croatian: Dozu je također potrebno smanjiti u bolesnika s blago do umjereno smanjenom funkcijom jetre.
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.
Croatian: Jevtana se izdaje samo na recept i smije se primjenjivati samo na odjelima za kemoterapiju (primjenu lijekova protiv raka) pod nadzorom liječnika iskusnog u primjeni kemoterapije.
English: It decided that Jevtana's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Zaključio je da koristi lijeka Jevtana nadmašuju s njim povezane rizike te je preporučio davanje odobrenja za stavljanje lijeka u promet.
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.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji smatrao je kako je sposobnost lijeka Jevtana da produži ukupno preživljenje bolesnika oboljelih od metastatskog tumora prostate otpornog na kastraciju klinički značajna.
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).
Croatian: Jevtana se primjenjuje u kombinaciji s prednizonom ili prednizolonom (protuupalnim lijekovima) u bolesnika koji su prethodno liječeni docetakselom (drugim lijekom protiv raka).
English: Jevtana is available as a concentrate and a solvent to be made up into a solution for infusion (drip) into a vein.
Croatian: Lijek Jevtana dostupan je kao koncentrat i otapalo za pripremu otopine za infuziju (drip) u venu.
English: Jevtana is a cancer medicine used to treat men with metastatic castration-resistant prostate cancer.
Croatian: Jevtana je lijek protiv raka koji se primjenjuje u liječenju muškaraca oboljelih od metastatskog raka prostate otpornog na kastraciju.
English: The active substance in Jevtana, cabazitaxel, belongs to the group of cancer medicines known as ‘taxanes'.
Croatian: Djelatna tvar u lijeku Jevtana jest kabazitaksel, koji pripada skupini lijekova protiv raka pod nazivom taksani.
English: What benefits of Jevtana have been shown in studies?
Croatian: Koje su koristi lijeka Jevtana dokazane u ispitivanjima?
English: How does Jevtana work?
Croatian: Kako djeluje Jevtana?
English: For the full list of all side effects reported with Jevtana, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Jevtana potražite u uputi o lijeku.
English: * PD50- 50% protective dose in cattle as described in Ph. Eur.
Croatian: * PD50 - 50% zaštitne doze (PD) za stoku kao što je propisano u monografiji europske farmakopeje (Ph.
English: monograph 0063.
Croatian: Eur.) 0063.
English: O Taiwan 3/97, A24 Cruzeiro and A Turkey
Croatian: Taiwan 3/97, A24 Cruzeiro i A Turkey
English: O Taiwan 3/97 ≥ 6 PD50*
Croatian: Taiwan 3/97 ≥ 6 PD50*
English: O1 Manisa, O Taiwan 3/97 and A Turkey
Croatian: O1 Manisa, O Taiwan 3/97 i
English: SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: SAT2 Saudi Arabi ≥ 6 PD50*
English: A24 Cruzeiro and A Turkey 14/98 ≥ 6 PD50*
Croatian: A24 Cruzeiro i A Turkey 14/98 ≥ 6 PD50*
English: O1 Manisa, O1 BFS and A 24 Cruzeiro ≥ 6 PD50*
Croatian: O1 Manisa, O1 BFS i A 24 Cruzeiro ≥ 6 PD50*
English: A22 Iraq and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: A22 Iraq & SAT2 Saudi Arabia ≥ 6 PD50*
English: A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
Croatian: A22 Iraq i A24 Cruzeiro ≥ 6 PD50*
English: A Turkey 14/98, Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: A Turkey 14/98, Asia1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, O1 BFS and O Taiwan 3/97 ≥ 6 PD50*
Croatian: O1 Manisa, O1 BFS i O Taiwan 3/97 ≥ 6 PD50*
English: A24 Cruzeiro, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: A24 Cruzeiro, A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa and O1 BFS ≥ 6 PD50*
Croatian: O1 Manisa i O1 BFS ≥ 6 PD50*
English: A22 Iraq, A24 Cruzeiro and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: A22 Iraq, A24 Cruzeiro & SAT2 Saudi Arabia ≥ 6 PD50*
English: A Turkey 14/98 and Asia 1 Shamir ≥ 6 PD50*
Croatian: A Turkey 14/98 i Asia 1 Shamir ≥ 6 PD50*
English: Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: Azija 1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97 and A24 Cruzeiro ≥ 6 PD50*
Croatian: Taiwan 3/97 i A24 Cruzeiro ≥ 6 PD50*
English: A24 Cruzeiro and Asia 1 Shamir ≥ 6 PD50*
Croatian: A24 Cruzeiro i Asia 1 Shamir ≥ 6 PD50*
English: O1 Manisa, O1 BFS and A22 Iraq ≥ 6 PD50*
Croatian: O1 Manisa, O1 BFS i A22 Iraq ≥ 6 PD50*
English: O Taiwan 3/97, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: Taiwan 3/97, A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: A22 Iraq and Asia1 Shamir ≥ 6 PD50*
Croatian: A22 Iraq i Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa, 01 BFS and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: O1 Manisa, 01 BFS & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa and A24 Cruzeiro ≥ 6 PD50*
Croatian: O1 Manisa i A24 Cruzeiro ≥ 6 PD50*
English: A24 Cruzeiro, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Croatian: A24 Cruzeiro, A Turkey 14/98 i Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and Asia1 Shamir ≥ 6 PD50*
Croatian: O1 BFS, O Taiwan 3/97 i Asia1 Shamir ≥ 6 PD50*
English: O1 BFS and A24 Cruzeiro ≥ 6 PD50*
Croatian: O1 BFS i A24 Cruzeiro ≥ 6 PD50*
English: A22 Iraq, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50*
Croatian: A22 Iraq, A24 Cruzeiro i Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa, O1 BFS and A Turkey 14/98 ≥ 6 PD50*
Croatian: O1 Manisa, O1 BFS i A Turkey 14/98 ≥ 6 PD50*
English: O1 Manisa, O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
Croatian: O1 Manisa, O Taiwan 3/97 i A22 Iraq ≥ 6 PD50*
English: O1 Manisa, A24 Cruzeiro and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: O1 Manisa, A24 Cruzeiro & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97, A24 Cruzeiro and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: Taiwan 3/97, A24 Cruzeiro & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and A24 Cruzeiro ≥ 6 PD50*
Croatian: O1 BFS, O Taiwan 3/97 i A24 Cruzeiro ≥ 6 PD50*
English: O1 BFS, A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
Croatian: O1 BFS, A22 Iraq i A24 Cruzeiro ≥ 6 PD50*
English: O1 BFS, A22 Iraq and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: O1 BFS, A22 Iraq & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97, A22 Iraq and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: Taiwan 3/97, A22 Iraq & SAT2 Saudi Arabia ≥ 6 PD50*
English: A22 Iraq, Asai1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: A22 Iraq, Asia1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 BFS and A22 Iraq ≥ 6 PD50*
Croatian: O1 BFS i A22 Iraq ≥ 6 PD50*
English: O Taiwan 3/97, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Croatian: Taiwan 3/97, A Turkey 14/98 i Asia1 Shamir ≥ 6 PD50*
English: O Taiwan 3/97, A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
Croatian: Taiwan 3/97, A22 Iraq i A24 Cruzeiro ≥ 6 PD50*
English: O1 BFS, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: O1 BFS, A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: O1 BFS, O Taiwan 3/97 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, O Taiwan 3/97 and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: O1 Manisa, O Taiwan 3/97 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
Croatian: O1 BFS, O Taiwan 3/97 i A22 Iraq ≥ 6 PD50*
English: O1 Manisa, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: O1 Manisa, A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
Croatian: Taiwan 3/97 i A22 Irak ≥ 6 PD50*
English: O1 BFS, Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: O1 BFS, Asia 1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50*
Croatian: Taiwan 3/97, A24 Cruzeiro i Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa, A24 Cruzeiro and A Turkey 14/98 ≥ 6 PD50*
Croatian: O1 Manisa i A24 Cruzeiro i A Turkey 14/98 ≥ 6 PD50*
English: O1 Manisa, A22 Iraq and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: O1 Manisa, A22 Iraq & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: O1 Manisa, Asia 1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 BFS, A22 Iraq and Asia1 Shamir ≥ 6 PD50*
Croatian: O1 BFS, A22 Iraq i Asia1 Shamir ≥ 6 PD50*
English: O Taiwan 3/97, A22 Iraq and Asia1 Shamir ≥ 6 PD50*
Croatian: Taiwan 3/97, A22 Iraq i Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa and A22 Iraq ≥ 6 PD50*
Croatian: O1 Manisa i A22 Iraq≥ 6 PD50*
English: O1 Manisa, O1 BFS and Asia1 Shamir ≥ 6 PD50*
Croatian: O1 Manisa, O1 BFS i Asia1 Shamir ≥ 6 PD50*
English: O Taiwan 3/97, Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: Taiwan 3/97, Asia 1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: O1 Manisa & SAT2 Saudi Arabia ≥ 6PD50*
English: O1 BFS and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: O1 BFS & SAT2 Saudi Arabia ≥ 6PD50*
English: O1 Manisa, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Croatian: O1 Manisa, A Turkey 14/98 i Asia1 Shamir ≥ 6 PD50*
English: O Taiwan 3/97 and Asia1 Shamir ≥ 6 PD50*
Croatian: Taiwan 3/97 i Asia1 Shamir ≥ 6 PD50*
English: O1 BFS and Asia1 Shamir ≥ 6 PD50*
Croatian: O1 BFS i Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Croatian: O1 BFS, A Turkey 14/98 i Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50*
Croatian: O1 BFS, A24 Cruzeiro i Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa and Asia1 Shamir ≥ 6 PD50*
Croatian: O1 Manisa i Asia1 Shamir ≥ 6 PD50*
English: O Taiwan 3/97 and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: Taiwan 3/97 & SAT2 Saudi Arabia ≥ 6PD50*
English: O1 Manisa, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50*
Croatian: O1 Manisa i A24 Cruzeiro i Asia1 Shamir ≥ 6 PD50*
English: A24 Cruzeiro and SAT2 Saudi Arabia ≥ 6 PD50*
Croatian: A Cruzeiro & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa and A Turkey ≥ 6 PD50*
Croatian: O1 Manisa i A Turkey 14/98 ≥ 6 PD50*
English: O Taiwan 3/97 and A Turkey 14/98 ≥ 6 PD50*
Croatian: OTaiwan 3/97 i A Turkey 14/98 ≥ 6 PD50*
English: O1 Manisa and O Taiwan ≥ 6 PD50*
Croatian: O1 Manisa i O Taiwan 3/97 ≥ 6 PD50*
English: O1 BFS and O Taiwan ≥ 6 PD50*
Croatian: O1 BFS i O Taiwan 3/97 ≥ 6 PD50*
English: O1 BFS and A Turkey ≥ 6 PD50*
Croatian: O1 BFS i A Turkey 14/98 ≥ 6 PD50*
English: The following information is intended for health care professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
English: • At the request of the European Medicines Agency
Croatian: • na zahtjev Europske agencije za lijekove;
English: There is limited evidence of a smaller increased risk following the second dose.
Croatian: Postoje ograničeni dokazi o manje povećanom riziku nakon druge doze.
English: Store in a refrigerator (2 °C to 8 °C).
Croatian: Čuvati u hladnjaku (od 2°C do 8°C).
English: Effectiveness % [95%CI]
Croatian: Učinkovitost % [95%CI]
English: Date of first authorisation: 27 June 2006
Croatian: Datum prvog odobrenja: 27. lipnja 2006.
English: In the general safety analyses, no specific safety concerns were identified.
Croatian: Analize opće sigurnosti nisu pokazale specifična sigurnosna pitanja.
English: Statistically significant
Croatian: Statistički značajno
English: Date of latest renewal: 18 May 2011
Croatian: Datum posljednje obnove odobrenja: 18. svibnja 2011.
English: As always, please take care to wash your hands thoroughly after changing soiled nappies.
Croatian: Molimo pazite da, kao i inače, dobro operete ruke nakon mijenjanja prljavih pelena.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
English: There was an extension of REST conducted in Finland only.
Croatian: Produžetak ispitivanja REST provodio se samo u Finskoj.
English: See sections 4.2 and 5.1.
Croatian: Vidjeti dijelove 4.2 i 5.1.
English: Telephone: Telefax:
Croatian: Tel: Fax:
English: This leaflet was last revised in:
Croatian: Ova uputa je zadnji puta revidirana u
English: Parents/guardians should be advised to promptly report such symptoms to their healthcare provider.
Croatian: Roditelje/staratelje se mora savjetovati da odmah prijave takve simptome svom zdravstvenom radniku.
English: Infectious Units As lower confidence limit (p = 0.95)
Croatian: infektivnih jedinica kao donja granica pouzdanosti (p = 0,95)
English: If the problem recurs, additional replacement doses should not be given.
Croatian: Ako se problem ponovi, ne smije se davati dodatna zamjenska doza.
English: The presence of a minor infection is not a contraindication for immunisation.
Croatian: Prisutnost blage infekcije nije kontraindikacija za imunizaciju.
English: Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines (or other vaccines).
Croatian: Obavijestite svog liječnika ili ljekarnika ako Vaše dijete uzima, nedavno je uzelo ili bi moglo uzeti bilo koje druge lijekove (ili druga cjepiva).
English: RotaTeq with food and drink
Croatian: RotaTeq s hranom i pićem
English: Efficacy in premature infants
Croatian: Djelotvornost u prijevremeno rođene dojenčadi
English: The results of these analyses are presented in the following tables.
Croatian: Rezultati ovih analiza prikazani su u tablicama niže.
English: The dose administered to mice was approximately 2.79 x 10
Croatian: Doza koja je davana miševima bila je oko 2,79 x 10
English: One dose (2 ml) contains:
Croatian: Jedna doza (2 ml) sadrži:
English: 1 dose (2 ml)
Croatian: 1 doza (2 ml)
English: Open the dosing tube in 2 easy motions:
Croatian: Otvorite tubu za doziranje u 2 jednostavna pokreta:
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)
Croatian: Prema učestalosti, nuspojave su razvrstane kao: vrlo često (>1/10); često (>1/100 i <1/10); manje često (>1/1000 i <1/100); rijetko (>1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka)
English: Hospitalization due to RVGE 98% [83,100]
Croatian: Hospitalizacija zbog RVGE 98% [83; 100]
English: Infants who have known or suspected immunodeficiency (see sections 4.4 and 4.8).
Croatian: Dojenčad za koju se zna ili sumnja da su imunodeficijentna (vidjeti dijelove 4.4 i 4.8).
English: Co-administration resulted in an acceptable safety profile.
Croatian: Istodobna primjena imala je prihvatljiv sigurnosni profil.
English: Contact a doctor/health care professional right away if your child experiences one of the following symptoms:
Croatian: Odmah se javite liječniku/zdravstvenom radniku ako Vaše dijete ima neko od sljedećih simptoma:
English: - your child is allergic to any of the components of this vaccine (see section 6 Contents of the pack and other information).
Croatian: - ako je Vaše dijete alergično na bilo koji sastojak cjepiva (pogledajte dio 6. Sadržaj pakiranja i druge informacije).
English: In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovo cjepivo se ne smije miješati s drugim lijekovima.
English: This Finnish Extension Study (FES) included a subset of 20,736 subjects that had been enrolled previously in REST.
Croatian: Finnish Extension Study (FES) ispitivanje uključilo je 20 736 ispitanika koji su bili prethodno uključeni i u REST ispitivanje.
English: • Not known (frequency cannot be estimated from the available data): irritability
Croatian: • Nepoznata učestalost (učestalost se ne može procijeniti iz dostupnih podataka): razdražljivost
English: (A residual drop may remain in the tip of the tube.)
Croatian: (U vršku tube može ostati koja kap.)
English: If necessary, the third (last) dose may be given up to the age of 32 weeks (see section 5.1).
Croatian: Ako je potrebno, treća (posljednja) doza cjepiva može se primijeniti do 32. tjedna starosti djeteta (vidjeti dio 5.1).
English: 33,140 vaccinated 26,167 unvaccinated Aged ≥7 months Received 3 doses
Croatian: 33 140 cijepljenih 26 167 necijepljenih U dobi od ≥7 mjeseci Primilo 3 doze
English: Excipient with known effect: This vaccine contains 1080 mg sucrose (see section 4.4).
Croatian: Pomoćna tvar s poznatim učinkom: Ovo cjepivo sadrži 1080 mg saharoze (vidjeti dio 4.4).
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.
Croatian: Tijekom razdoblja praćenja od 0-30 dana nakon cijepljenja nije bilo statistički značajne razlike u stopi Kawasakijeve bolesti u usporedbi s očekivanom osnovnom stopom.
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.
Croatian: • Alergijske reakcije (učestalost se ne može procijeniti iz dostupnih podataka), koje mogu biti teške (anafilaksa), a mogu uključivati: alergijsko oticanje koje može zahvatiti lice, usne, jezik ili grlo.
English: 402 cases 2,559 controls* Aged <8 years Received 3 doses
Croatian: 402 slučaja 2559 kontrola* U dobi od <8 godina Primilo 3 doze
English: Cohort study (France)
Croatian: Kohortno ispitivanje (Francuska)
English: RotaTeq SHOULD UNDER NO CIRCUMSTANCES BE INJECTED.
Croatian: RotaTeq SE NI U KOJEM SLUČAJU NE SMIJE INJICIRATI.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Croatian: S obzirom na to da je korist cijepljenja značajna u ovoj skupini dojenčadi, cijepljenje ne treba izostaviti ili odgoditi.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: * Severe defined as a score >16/24 using a validated clinical scoring system based on the intensity and duration of symptoms (fever, vomiting, diarrhoea and behavioural changes) Statistically significant
Croatian: * Teški oblik definiran kao rezultat >16/24 primjenom validiranog kliničkog sustava ocjenjivanja koji se temelji na snazi i trajanju simptoma (vrućice, povraćanja, dijareje i promjena u ponašanju) Statistički značajno
English: There are no restrictions on taking food or liquid, including breast milk, either before or after vaccination with RotaTeq.
Croatian: Nema ograničenja za uzimanje hrane ili pića, uključujući majčino mlijeko, prije ili nakon cijepljenja RotaTeq cjepivom.