FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease an adjustment in the dose is recommended (see section 4.2).
Croatian: Za bolesnike s rakom dojke i koštanim metastazama koji se liječe radi sprječavanja koštanih poremećaja te s umjerenim (CLcr ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (CLcr <30 ml/min), se preporučuje prilagodba doze (vidjeti dio 4.2).
English: 2 mg 4 mg 6 mg For these patients and dosages, the median time to achieve normocalcaemia was 4 to 7 days.
Croatian: Za ove bolesnike i doziranje, medijan vremena do postizanja normalne razine kalcija u krvi iznosio je 4 do 7 dana.
English: Albumin-corrected serum calcium (mg/dl)
Croatian: kalcij u serumu korigiran albuminom (mmol/l)
English: Uncommon (may affect less than 1 in 100 people)
Croatian: Manje često (mogu se javiti u manje od 1 na 100 osoba )
English: For intravenous use only.
Croatian: Isključivo za primjenu u venu.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed:
Croatian: Za bolesnike s rakom dojke i koštanim metastazama te s umjerenim oštećenjem bubrega (Clcr≥30 i <50 ml/min) ili teškim oštećenjem bubrega (Clcr <30 ml/min) koji se liječe radi sprječavanja koštanih poremećaja, treba slijediti sljedeće preporuke za doziranje:
English: Care must be taken not to administer ibandronic acid injection via intra-arterial or paravenous administration as this could lead to tissue damage.
Croatian: Potreban je oprez pri primjeni kako se injekcija ibandronatne kiseline ne bi primijenila intraarterijski ili paravenozno, što može dovesti do oštećenja tkiva.
English: Relative Risk Reduction New morphometric vertebral fractures
Croatian: Smanjenje relativnog rizika Novi prijelomi kralježaka, utvrđeni morfometrički
English: ibandronic acid 2.5 mg daily (N=575)
Croatian: Ibandronatna kiselina 2,5 mg jedanput dnevno (n=575)
English: * Mean change from baseline to last assessment.
Croatian: p=0,004 * Srednja vrijednost promjene od početne vrijednosti do zadnje procjene.
English: Rare (may affect up to 1 in 1000 people): • hives
Croatian: Rijetko (mogu se javiti u manje od 1 na 1000 osoba) • koprivnjača
English: Ibandronic acid 3 mg intravenous injection, administered every 3 months, was shown to be at least as effective as oral ibandronic acid 2.5 mg daily in a 2-year, randomised, double-blind, multicentre, noninferiority study (BM16550) of postmenopausal women (1386 women aged 55 - 80) with osteoporosis (lumbar spine BMD T-score below -2.5 SD at baseline).
Croatian: Dvogodišnje, randomizirano, dvostruko slijepo, multicentrično, ispitivanje neinferiornosti (BM 16550) u žena s osteoporozom (početna T-vrijednost mineralne gustoće kosti lumbalne kralježnice manja od -2,5 SD) i u postmenopauzi (1386 žena od 55 do 80 godina) pokazalo je da intravenska injekcija ibandronatne kiseline od 3 mg koja se primjenjuje svaka tri mjeseca barem jednako djelotvorna kao peroralno primijenjena ibandronatna kiselina od 2,5 mg koja se uzima jedanput dnevno.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
Croatian: 2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka s 3 ml otopine sadrži 3 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
English: Care must be taken not to administer ibandronic acid concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
Croatian: Potreban je oprez kako se koncentrat ibandronatne kiseline za otopinu za infuziju ne bi primijenio intraarterijski ili paravenski, jer to može dovesti do oštećenja tkiva.
English: In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg is an adequate single dose.
Croatian: U većine bolesnika s teškom hiperkalcijemijom (kalcij u serumu korigiran albuminom* ≥3 mmol/l ili ≥12 mg/dl) prikladna je jednokratna doza od 4 mg.
English: Neoplasms benign, malignant, and unspecified
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine dobroćudne novotvorine kože
English: = serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8 Or
Croatian: = kalcij u serumu (mmol/l) - [0,02 x albumin (g/l)] + 0,8 ili kalcij u serumu korigiran albuminom (mg/dl)
English: In the prevention of skeletal events in patients with breast cancer and bone metastases, treatment is most frequently associated with asthenia followed by rise in body temperature and headache.
Croatian: U većini slučajeva nije potrebno posebno liječenje, a simptomi se povlače nakon nakoliko sati/dana.U sprječavanju koštanih događaja u bolesnika s rakom dojke i koštanim metastazama liječenje je najčešće povezano s astenijom praćenom porastom tjelesne temperature i glavoboljom.
English: EU/1/12/798/005 1 pre-filled syringe EU/1/12/798/006 4 pre-filled syringe
Croatian: EU/1/12/798/005 1 napunjena štrcaljka EU/1/12/798/006 4 napunjene štrcaljke
English: Patients treated with ibandronic acid should be given the package leaflet and the patient reminder card. Ibandronic acid therapy should only be initiated by physicians experienced in the treatment of cancer.
Croatian: Liječenje ibandronatnom kiselinom smiju započeti samo liječnici s iskustvom u liječenju raka.
English: • One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
Croatian: • Jedna napunjena štrcaljka s 3 ml otopine sadrži 3 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
English: For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed (see section 5.2):
Croatian: Za bolesnike s rakom dojke i koštanim metastazama te s umjerenim oštećenjem bubrega (klirens kreatinina ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (klirens kreatinina <30 ml/min) koji se liječe radi sprječavanja koštanih poremećaja, treba slijediti sljedeće preporuke za doziranje (vidjeti dio 5.2):
English: • The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate and water for injections.
Croatian: • Drugi sastojci su natrijev klorid, acetatna kiselina, natrijev acetat trihidrat i voda za injekcije.
English: For patients with mild renal impairment (CLcr ≥50 and <80 ml/min) no dose adjustment is necessary.
Croatian: Za bolesnike s blagim oštećenjem bubrega (klirens kreatinina ≥50 i <80 ml/min) nije potrebna prilagodba doze.
English: Therefore, ibandronic acid should not be used during pregnancy.
Croatian: Stoga se ibandronatna kiselina ne smije koristiti u trudnoći.
English: Ibandronic acid Accord 6 mg concentrate for solution for infusion Each vial contains 6 ml of concentrate.
Croatian: Ibandronic acid Accord 6 mg koncentrat za otopinu za infuziju Jedna bočica sadrži 6 ml koncentrata.
English: Pyrexia,Influenz a-like illness**, oedema peripheral, asthenia, thirst
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija, bolest slična gripi**, edemi okrajina, astenija, žeđ hipotermija
English: Ocular inflammation*†
Croatian: Poremećaji oka upala oka*†
English: The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other active substances.
Croatian: Čini se da put izlučivanja putem bubrega ne obuhvaća poznate kisele ni bazne transportne sustave uključene u izlučivanje drugih djelatnih tvari (vidjeti dio 4.5).
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion Each vial contains 2 ml of concentrate.
Croatian: Ibandronic acid Accord 2 mg koncentrat za otopinu za infuziju Jedna bočica sadrži 2 ml koncentrata.
English: Do not use Ibandronic acid Accord
Croatian: Nemojte primjenjivati lijek Ibandronic acid Accord
English: Renal clearance of ibandronic acid in patients with various degrees of renal impairment is linearly related to creatinine clearance (CLcr).
Croatian: Bubrežni klirens ibandronatne kiseline u bolesnika s različitim stupnjevima oštećenja funkcije bubrega linearno je povezan s klirensom kreatinina.
English: Excipient with known effect Ibandronic acid injection is essentially sodium free.
Croatian: Pomoćna tvar s poznatim učinkom Injekcija ibandronatne kiseline sadrži zanemarive količine natrija.
English: Diarrhoea, vomiting, dyspepsia, gastrointestinal pain, tooth disorder
Croatian: Poremećaji probavnog sustava proljev, povraćanje, dispepsija, gastrointestinalna bol, poremećaji zuba gastroenteritis, gastritis, ulceracija usta, disfagija, heilitis
English: Ibandronic acid Accord concentrate for solution for infusion should be administered as an intravenous infusion.
Croatian: Ibandronic acid Accord koncentrat za otopinu za infuziju treba primijeniti kao intravensku infuziju
English: • The other ingredients are sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.
Croatian: • Drugi sastojci su natrijev klorid, natrijev acetat trihidrat, ledena acetatna kiselina i voda za injekcije.
English: Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Croatian: Ibandronatna kiselina je indicirana u odraslih za sprječavanje koštanih poremećaja (patološki prijelomi, komplikacije na kostima koje zahtijevaju radioterapiju ili operaciju) u bolesnika s rakom dojke i koštanim metastazama liječenje hiperkalcijemije nastale kao posljedica tumora s metastazama ili bez njih 4.2 Doziranje i način primjene
English: ibandronic acid 2.5 mg daily (N=334)
Croatian: Ibandronatna kiselina 2,5 mg jedanput dnevno (N=334)
English: Excipients: sodium chloride, acetic acid, glacial, sodium acetate trihydrate and water for injections.
Croatian: Pomoćne tvari: natrijev klorid, acetatna kiselina, ledena, natrijev acetat trihidrat i voda za injekcije.
English: • flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints.
Croatian: • simptomi nalik gripi, uključujući vrućicu, tresavicu i drhtanje, osjećaj nelagode, bol u kostima,
English: Ibandronic acid concentrate for solution for infusion should be administered as an intravenous infusion.
Croatian: Koncentrat ibandronatne kiseline za otopinu za infuziju treba primijeniti kao intravensku infuziju.
English: One pre-filled syringe of 3 ml solution contains 3 mg of ibandronic acid (as sodium monohydrate).
Croatian: Jedna napunjena štrcaljka s 3 ml otopine sadrži 3 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
English: Ibandronic acid Accord 6 mg concentrate for solution for infusion One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as 6.75 mg ibandronate sodium monohydrate).
Croatian: Ibandronic acid Accord 2 mg koncentrat za otopinu za infuziju Jedna bočica sa 2 ml koncentrata za otopinu za infuziju sadrži 2 mg ibandronatne kiseline (što odgovara 2,25 mg natrijevog ibandronat hidrata) Ibandronic acid Accord 6 mg koncentrat za otopinu za infuziju Jedna bočica sa 6 ml koncentrata za otopinu za infuziju sadrži 6 mg ibandronatne kiseline (što odgovara 6,75 mg natrijevog ibandronat hidrata)
English: ibandronic acid 2.5 mg daily (N=377)
Croatian: Ibandronatna kiselina 2,5 mg jedanput dnevno (N=377)
English: Ibandronic acid should not be used during pregnancy.
Croatian: Ibandronatna kiselina se ne smije koristiti u trudnoći.
English: Each vial contains 6 mg of ibandronic acid (as sodium monohydrate).
Croatian: Jedna bočica sadrži 6 mg ibandronatne kiseline (u obliku natrijevog ibandronat hidrata).
English: Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck
Croatian: potentnost lijeka koji inibira resorpciju kostiju (rizik je veći za jako potentne spojeve), put primjene (rizik je veći za parenteralnu primjenu) i kumulativna doza terapije za resorpciju kostiju rak, komorbidna zdravstvena stanja (npr. anemija, koagulopatije, infekcija), pušenje istovremene terapije: kortikosteroidi, kemoterapija, inhibitori angiogeneze, radioterapija glave i vrata loša zubna higijena, parodontne bolesti, loše podešene proteze, bolesti zuba u anamnezi, invazivni zubarski zahvati, npr. vađenje zuba
English: How to use Ibandronic acid Accord
Croatian: Kako primjenjivati Ibandronic acid Accord
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. sadrži zanemarive količine natrija.
English: Ibandronic acid Accord 6 mg concentrate for solution for infusion ibandronic acid
Croatian: Ibandronic acid Accord 6 mg koncentrat za otopinu za infuziju ibandronatna kiselina
English: Angioedema, Facial swelling/oedema, Urticaria
Croatian: Poremećaji kože i potkožnog tkiva osip angioedem, oticanje lica/edem, urtikarija
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion ibandronic acid
Croatian: Ibandronic acid Accord 2 mg koncentrat za otopinu za infuziju ibandronatna kiselina
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion Ibandronic acid Accord 6 mg concentrate for solution for infusion ibandronic acid
Croatian: Ibandronic acid Accord 2 mg koncentrat za otopinu za infuziju Ibandronic acid Accord 6 mg koncentrat za otopinu za infuziju ibandronatna kiselina
English: How to store Ibandronic acid Accord
Croatian: Kako čuvati Ibandronic acid Accord
English: A flu-like syndrome consisting of fever, chills, bone and/or muscle ache-like pain has occurred.
Croatian: Javljala se bolest slična gripi koja je uključivala vrućicu, zimicu i stalne tupe bolove u kostima/mišićima.
English: 4 mg (4 ml of concentrate for solution for infusion)
Croatian: ≥30 klirens kreatinina <50 4 mg (4 ml koncentrata za otopinu za infuziju)
English: Ocular inflammatio
Croatian: Otopina za injekciju
English: NAME OF THE MEDICINAL PRODUCT Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe
Croatian: NAZIV LIJEKA Ibandronic acid Accord 3 mg otopina za injekciju u napunjenoj štrcaljki
English: An expected decrease in bone turnover, normal quality of bone and absence of defects in mineralization were also seen after two years of treatment with ibandronic acid 3 mg injection.
Croatian: Nakon dvije godine liječenja injekcijom ibandronatne kiseline od 3 mg primijećeno je očekivano smanjenje koštanog metabolizma, normalna kvaliteta kosti bez znakova poremećaja mineralizacije.
English: Sodium chloride Sodium acetate trihydrate Glacial acetic acid Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev klorid natrijev acetat trihidrat acetatna kiselina, ledena voda za injekcije
English: Trochanter BMD
Croatian: BMD cijelog kuka BMD vrata bedrene kosti BMD trohantera
English: Ibandronic acid should not be used during breastfeeding.
Croatian: Ibandronatna kiselina se ne smije koristiti za vrijeme dojenja.
English: Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe ibandronic acid
Croatian: Ibandronic acid Accord 3 mg otopina za injekciju u napunjenoj štrcaljki ibandronatna kiselina
English: Parathyroid disorder
Croatian: Endokrini poremećaji paratireoidni poremećaj
English: Ibandronic acid Accord concentrate for solution for infusion should be administered as an intravenous infusion.Care must be taken not to administer Ibandronic acid Accord concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
Croatian: . Potreban je oprez kako se Ibandronic acid Accord koncentrat za otopinu za infuziju ne bi primijenio intraarterijski ili paravenski, jer to može dovesti do oštećenja tkiva.
English: Prevention of skeletal events in patients with breast cancer and bone metastases
Croatian: Sprječavanje koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama
English: A statistically significant improvement in bone pain score was shown for intravenous ibandronic acid 6 mg compared to placebo.
Croatian: Ibandronatna kiselina 6 mg dana intravenski pokazala je u usporedbi s placebom statistički značajno poboljšanje rezultata kod boli u kostima.
English: NAME OF THE MEDICINAL PRODUCT Ibandronic acid Accord 2 mg concentrate for solution for infusion Ibandronic acid Accord 6 mg concentrate for solution for infusion
Croatian: Ibandronic acid Accord 2 mg koncentrat za otopinu za infuziju Ibandronic acid Accord 6 mg koncentrat za otopinu za infuziju
English: Ibandronic acid concentrate for solution for infusion should not be mixed with calcium containing solutions.
Croatian: Otopine koje sadrže kalcij ne smiju se miješati s Ibandronic acid koncentratom za otopinu za infuziju.
English: Osteonecrosis of jaw
Croatian: egzacerba cija astme
English: EXP 9.
Croatian: PRILOG III.
English: You should arrange an appointment to get the next injection as soon as possible.
Croatian: Ako ste zaboravili primijeniti Ibandronic acid Accord Morate se javiti liječniku i primiti sljedeću injekciju što je prije moguće.
English: Ibandronic acid Accord 3 mg injection Ibandronic acid
Croatian: Ibandronic acid Accord 3 mg injekcija ibandronatna kiselina i.v. primjena
English: • deafness
Croatian: • modrice
English: Cases of ONJ have been reported in the post marketing setting ibandronic acid.
Croatian: Prijavljeni su slučajevi osteonekroze čeljusti kod primjene ibandronatne kiseline nakon stavljanja lijeka u promet.
English: Dosage
Croatian: parosmija
English: Relative risk reduction New morphometric vertebral fractures
Croatian: Incidencija novih prijeloma kralježaka, utvrđeni morfometrički Smanjenje relativnog rizika za kliničke prijelome kralježaka
English: Ibandronic acid Accord 2 mg and 6 mg concentrate for solution for infusion (for oncology indications)
Croatian: Ibandronic acid Accord 2 mg i 6 mg koncentrat za otopinu za infuziju (za onkološke indikacije) Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).
English: In studies with daily i.v.
Croatian: D dnevno.
English: Excipients with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially sodium free.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, odnosno zanemarive količine natrija.
English: Please see the summary of product characteristics for more information.
Croatian: Dodatne informacije potražite u sažetku opisa svojstava lijeka.
English: Skin and subcutaneous tissue disorders
Croatian: Atipični lomovi bedrene kosti
English: EXP: Read the package leaflet for the shelf life after dilution.
Croatian: Rok valjanosti: Za rok valjanosti nakon razrjeđivanja pročitajte uputu o lijeku.
English: • You should take calcium and vitamin-D supplements while receiving Ibandronic acid Accord.
Croatian: • za vrijeme liječenja lijekom Ibandronic acid Accord neophodno je uzimati preparate s kalcijem i vitaminom D. Obavijestite liječnika ako to ne možete učiniti.
English: • skin rash
Croatian: • osip na koži
English: Gardasil should be administered as soon as possible after being removed from the refrigerator.
Croatian: Gardasil se mora primijeniti čim prije nakon što se izvadi iz hladnjaka.
English: Other medicines or vaccines and Gardasil
Croatian: Drugi lijekovi ili cjepiva i Gardasil
English: If you are from 14 years of age
Croatian: Ako ste u dobi od 14 godina i stariji
English: Consequently, the frequency of these adverse events is qualified as "not known".
Croatian: Prema tome, učestalost tih štetnih događaja je kvalificirana kao "nepoznato".
English: 20 micrograms.
Croatian: 20 mikrograma.
English: This leaflet was last revised in: {MM/YYYY}.
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}.
English: What you need to know before you receive Gardasil
Croatian: Što morate znati prije nego primite Gardasil
English: At the end of this period Gardasil should be used or discarded.
Croatian: Na kraju tog razdoblja, Gardasil treba primijeniti ili baciti.
English: Do not receive Gardasil if:
Croatian: Nemojte primiti Gardasil:
English: Therefore, tell the doctor or nurse if you fainted with a previous injection.
Croatian: Stoga, obavijestite liječnika ili medicinsku sestru ako ste se onesvijestili kod prijašnjih injekcija.
English: What Gardasil is and what it is used for
Croatian: Što je Gardasil i za što se koristi
English: N Number of cases
Croatian: N Broj slučajeva
English: Vaccination should be postponed until completion of pregnancy.
Croatian: Cijepljenje je potrebno odgoditi do kraja trudnoće.
English: * Post Marketing adverse events (frequency cannot be estimated from the available data).
Croatian: * štetni događaji nakon stavljanja u promet (učestalost se ne može utvrditi iz dostupnih podataka).
English: Efficacy against PIN grades 1/2/3 was not demonstrated.
Croatian: Djelotvornost protiv PIN-a stupnjeva 1/2/3 nije bila prikazana.
English: • you or your child developed an allergic reaction after receiving a dose of Gardasil.
Croatian: • ako ste Vi ili Vaše dijete razvili alergijsku reakciju nakon primljene doze cjepiva Gardasil
English: Gardasil is intended for adolescents and adults from 9 years of age onwards.
Croatian: Gardasil je namijenjen adolescentima i odraslima od 9 godina starosti nadalje.
English: In this study, a durable protection was statistically demonstrated to approximately 12 years.
Croatian: U tom je ispitivanju statistički pokazano da zaštita traje približno 12 godina.
English: The duration of immunity following a 3-dose series has been observed for up to 14 years post-vaccination.
Croatian: Trajanje imunosti nakon serije od 3 doze opaženo je do 14 godina nakon cijepljenja.
English: *, Guillain-Barré syndrome*, syncope sometimes accompanied by tonic-clonic movements*
Croatian: 1 *, Guillain-Barréov sindrom*, sinkopa ponekad popraćena toničko-kloničkim pokretima*
English: Date of first authorisation: 20 September 2006 Date of latest renewal: 27 July 2011
Croatian: Datum prvog odobrenja: 20. rujna 2006.
English: However, these data are insufficient to recommend use of Gardasil during pregnancy.
Croatian: Ipak, ovi podaci nisu dovoljni da se preporuči primjena cjepiva Gardasil tijekom trudnoće.
English: The safety and efficacy of Gardasil in children below 9 years of age have not been established.
Croatian: Sigurnost i djelotvornost cjepiva Gardasil u djece mlađe od 9 godina nisu ustanovljene.
English: Not all pack sizes are marketed.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja.
English: • you or your child is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Gardasil (listed under “other ingredients”- see section 6).
Croatian: • ako ste Vi ili Vaše dijete alergični (preosjetljivi) na bilo koju djelatnu tvar ili neki drugi sastojak cjepiva Gardasil (naveden pod "drugi sastojci" pogledajte dio 6.).
English: What other important information should you or your child know about Gardasil
Croatian: Što još važno Vi ili Vaše dijete morate znati o cjepivu Gardasil
English: Gardasil may not have an optimal effect if: • used with medicines that suppress the immune system.
Croatian: Djelovanje cjepiva Gardasil možda neće biti optimalno ako: • se daje s lijekovima koji potiskuju djelovanje imunološkog sustava.
English: • has a weakened immune system, for example due to a genetic defect, HIV infection or medicines that affect the immune system.
Croatian: • imate oslabljen imunološki sustav, npr. zbog prirođenog nedostatka, infekcije HIV-om ili lijekova koji utječu na imunološki sustav.