FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Silgard, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek Silgard uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group.
Croatian: Za usporedbu, ukupno 189 slučajeva vanjskih genitalnih lezija zabilježeno je u skupini od gotovo 8 000 žena koje su primile placebo.
English: What is the risk associated with Silgard?
Croatian: Koji su rizici povezani s lijekom Silgard?
English: The study testing Silgard given as 2 doses in girls aged 9 to 13 showed that that the two doses given six months apart were no less effective than the three-dose vaccination: all subjects had developed sufficient amounts of antibodies against HPV one month after their last dose.
Croatian: Ispitivanje kojim je testiran Silgard primijenjen u 2 doze u djevojčica u dobi od 9 do 13 godina pokazalo je da dvije doze primijenjene u razmaku od šest mjeseci nisu bile manje učinkovite od cijepljenja s tri doze: svi su subjekti razvili dovoljne količine protutijela protiv HPV-a mjesec dana nakon posljednje doze.
English: The studies also showed that Silgard provided some protection against lesions in the cervix linked to other cancer-causing types of HPV, including type 31.
Croatian: Ispitivanja su također pokazala da je Silgard pružio određenu zaštitu od lezija na grliću maternice uzrokovanih drugim tipovima HPV-a koji uzrokuju rak, uključujući tip 31.
English: Other information about Silgard:
Croatian: Ostale informacije o lijeku Silgard
English: There were no cases of anal cancer in the study but it is expected that protection against precancerous anal lesions will translate
Croatian: U ispitivanju nisu zabilježeni slučajevi raka anusa, ali očekuje se da prevencija premalignih lezija anusa predstavlja i prevenciju raka.
English: human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Croatian: Silgard cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
English: In addition, the results confirmed the ability of Silgard to protect against lesions and HPV infection in 24- to 45-year-old women.
Croatian: Osim toga, rezultati su potvrdili sposobnost zaštite lijeka Silgard od lezija i infekcija HPV-om u žena u dobi od 24 do 45 godina.
English: In four main studies of Silgard given as three doses, Silgard was compared with placebo (a dummy vaccine) in almost 21,000 women aged between 16 and 26 years.
Croatian: U četiri glavna ispitivanja lijeka Silgard primjenjivanog u tri doze, Silgard je uspoređen s placebom (lažnim cjepivom) u gotovo 21 000 žena u dobi od 16 do 26 godina.
English: For people aged fourteen or above, Silgard is normally given according to a three-dose schedule with the second dose given two months after the first and the third given four months after the second..
Croatian: Za osobe u dobi od četrnaest godina ili starije, Silgard se obično primjenjuje u tri doze, pri čemu se druga doza daje dva mjeseca nakon prve doze, a treća četiri mjeseca nakon druge.
English: A similar effect of Silgard was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
Croatian: Slično djelovanje lijeka Silgard uočeno je prilikom analize koja je uključivala lezije grlića maternice uzrokovane s druga dva tipa HPV-a (tipovi 6 i 11).
English: In the four studies in 21,000 women, out of the more than 8,000 women vaccinated with Silgard who had never been infected by HPV types 6, 11, 16 or 18 before, one woman developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
Croatian: U četiri ispitivanja provedena u 21 000 žena, od preko 8 000 žena cijepljenih lijekom Silgard koje nikad nisu bile zaražene tipovima HPV-a 6, 11, 16 ili 18, jedna je žena razvila premaligne lezije grlića maternice koje su mogle biti uzrokovane tipom HPV-a 16 ili 18.
English: For people aged nine to thirteen years, Silgard can be given as two doses six months apart.
Croatian: Za osobe u dobi od devet do trinaest godina, Silgard se primjenjuje kao dvije doze u razmaku od šest mjeseci.
English: Finally, a main study in around 4,000 boys and men from 16 to 26 years of age compared the vaccine against placebo to test the vaccine's effect in preventing genital warts, precancerous anal lesions and anal cancer.
Croatian: Naposljetku, u glavnom ispitivanju koje je obuhvatilo oko 4 000 mladića i muškaraca u dobi od 16 do 26 godina cjepivo je uspoređeno s placebom kako bi se ispitalo djelovanje cjepiva u sprječavanju genitalnih bradavica, premalignih lezija anusa i raka anusa.
English: Three studies of Silgard given as three doses looked at the ability of Silgard to prevent infection with HPV types 6, 11, 16 and 18 and genital lesions caused by these HPV types in almost 4,000 women aged between 24 and 45 years, and at the development of antibodies against these HPV types in around 1,700 girls and boys aged between nine and 15 years.
Croatian: Tri ispitivanja lijeka Silgard primijenjenog u tri doze istražila su sposobnost lijeka Silgard za sprječavanje infekcija uzrokovanih tipovima HPV-a 6, 11, 16 i 18, te genitalnih lezija uzrokovanih tipovima HPV-a u gotovo 4 000 žena u dobi između 24 i 45 godina, te razvoj protutijela protiv ovih tipova HPV-a u otprilike 1 700 djevojčica i dječaka u dobi od devet do 15 godina.
English: Another study in around 800 girls and women compared the effect of two doses of Silgard in girls aged nine to 13 years with the effect of three doses in girls and young women aged 16 to 24 years.
Croatian: Drugo ispitivanje provedeno na otprilike 800 djevojaka i žena usporedilo je djelovanje dvije doze lijeka Silgard u djevojčica u dobi od devet do 13 godina s djelovanjem tri doze u djevojaka i mladih žena u dobi od 16 do 24 godine.
English: The CHMP decided that Silgard's benefits are greater than its risks and recommended that it be given
Croatian: CHMP je zaključio da koristi od lijeka Silgard nadmašuju s njim povezane rizike i preporučio je izdavanje odobrenja za stavljanje lijeka u promet.
English: What benefit has Silgard shown during the studies?
Croatian: Koje su koristi lijeka Silgard dokazane u ispitivanjima?
English: In the three studies on genital lesions 2 women out of almost 8,000 in the Silgard group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina.
Croatian: U tri studije genitalnih lezija, genitalne bradavice razvile su se u dvije žene od gotovo 8 000 u skupini koja je primala lijek Silgard, te nije bilo slučaja premalignih lezija vulve ili vagine.
English: The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16 and 18
Croatian: Glavna mjera djelotvornosti bio je razvoj protutijela protiv tipova HPV-a 6, 11, 16 i 18 mjesec dana nakon posljednje doze.
English: For the full list of all side effects reported with Silgard, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Silgard potražite u uputi o lijeku.
English: The powder or cake is white.
Croatian: Prašak ili kolačić je bijel.
English: See your doctor immediately if you notice any of these.
Croatian: Odmah posjetite svog liječnika ako primijetite bilo koje od navedenog.
English: 44 micrograms
Croatian: 44 mikrograma
English: If not used within 8 hours, do not administer the vaccine.
Croatian: Ako se ne upotrijebi unutar 8 sati, ne primijenjujte cjepivo.
English: • decreased feeling or sensitivity, especially in the skin
Croatian: • smanjen osjet ili osjetljivost, pogotovo na koži
English: • you have an infection with a high temperature (over 38°C).
Croatian: • imate li infekciju praćenu visokom temperaturom (preko 38°C).
English: Remove the needle protector, which on occasion can be a little stiff.
Croatian: Skinite zaštitu za iglu, koja povremeno može biti malo kruta.
English: Although delay is not recommended, stability has been demonstrated for 8 hours at 30°C after reconstitution.
Croatian: Iako se odgoda ne preporučuje, dokazana je stabilnost pri 30°C unutar razdoblja od 8 sati nakon rekonstitucije.
English: These infections are passed easily from person to person and can cause death if not treated.
Croatian: Ove infekcije se lako prenose s osobe na osobu i ako se ne liječe mogu prouzrokovati smrt.
English: Children (2-17 years) with anatomical or functional asplenia
Croatian: Djeca (2 - 17 godina) s anatomskom ili funkcionalnom asplenijom
English: Nimenrix should be used in accordance with available official recommendations.
Croatian: Nimenrix treba primjenjivati u skladu sa službenim preporukama.
English: If this applies to you, the vaccination will not be given until you are feeling better.
Croatian: Ako se ovo odnosi na Vas, cjepivo ćete primiti tek kada se budete osjećali bolje.
English: A minor infection such as a cold should not be a problem.
Croatian: Manja infekcija poput prehlade ne bi trebala predstavljati problem.
English: • you are allergic to the active substances or any of the other ingredients in this vaccine (listed in section 6).
Croatian: • ste alergični na djelatne tvari ili neki drugi sastojak ovog cjepiva (naveden u dijelu 6.).
English: • septicaemia - an infection of the blood.
Croatian: • sepsa - infekcija krvi.
English: • pain in the arms or legs
Croatian: • bol u rukama ili nogama
English: You will be informed when you or your child should come back for the next injection.
Croatian: Bit ćete obaviješteni kada Vi ili Vaše dijete morate doći na sljedeću injekciju.
English: 1 year CSR Q1 2017 3 year CSR Q1 2019 5 year CSR Q1 2021
Croatian: 1 godina CSR Q1 2017 3 godine CSR Q1 2019 5 godina CSR Q1 2021
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change in 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: Date of first authorisation: 20 April 2012 Date of latest renewal: 16 February 2017
Croatian: Datum posljednje obnove odobrenja: 16. veljače 2017.
English: • you have a bleeding problem or you bruise easily.
Croatian: • imate li problema s krvarenjem ili lako dobivate modrice.
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego primijenite ovo cjepivo jer sadrži Vama važne podatke.
English: If you or your child misses a scheduled injection, it is important that you make another appointment.
Croatian: Ako Vi ili Vaše dijete propustite dogovorenu injekciju, važno je da zakažete novi termin cijepljenja.
English: Pack sizes of 1, 10 and 100
Croatian: Veličine pakiranja od 1, 10 i 100
English: After reconstitution, the vaccine should be used promptly.
Croatian: Nakon rekonstitucije, cjepivo se mora odmah upotrijebiti.
English: However, talk to your doctor or nurse first.
Croatian: Međutim, razgovarajte prvo s liječnikom ili medicinskom sestrom.
English: Myalgia Pain in extremity
Croatian: Mialgija Bol u ekstremitetima
English: These antibodies help protect you against the diseases.
Croatian: Ta protutijela pomažu u zaštiti od bolesti.
English: • meningitis - an infection of the tissue that lines the brain and spinal cord.
Croatian: • meningitis - infekcija tkiva koje obavija mozak i leđnu moždinu
English: If you have a weak immune system (such as due to HIV infection or medicines that affect the immune system) you may not get a full benefit from Nimenrix.
Croatian: Ako imate oslabljen imunološki sustav (kao što je to zbog infekcije HIV-om ili lijekova koji utječu na imunološki sustav), možda od cjepiva Nimenrix nećete dobiti potpunu zaštitu.
English: Non-clinical data reveal no special hazard for humans based on local tolerance, acute toxicity, repeated dose toxicity, developmental/reproductive toxicity and fertility studies.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja lokalne podnošljivosti, akutne toksičnosti, toksičnosti ponovljenih doza, razvojne/reproduktivne toksičnosti, te ispitivanja plodnosti.
English: An additional primary dose of Nimenrix may be considered appropriate for some individuals (see section 4.4).
Croatian: Dodatna primarna doza cjepiva Nimenrix može se smatrati prikladnom u pojedinih osoba (vidjeti dio 4.4).
English: However, do not drive or use any machines if you are feeling unwell.
Croatian: Međutim, ako se ne osjećate dobro, nemojte voziti ili upravljati bilo kakvim strojevima.
English: Similar responses to groups A and C were observed after one or two doses (see section 5.1).
Croatian: Slični odgovori za grupe A i C primijećeni su nakon jedne ili dvije doze (vidjeti dio 5.1).
English: Nimenrix will be given to you by a doctor or nurse.
Croatian: Nimenrix će Vam dati liječnik ili medicinska sestra.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na trudnoću, embrionalni/fetalni razvoj, porod ili postnatalni razvoj (vidjeti dio 5.3).
English: Make sure you or your child finishes the complete vaccination course.
Croatian: Vodite računa da Vi ili Vaše dijete završite cijeli tijek cijepljenja.
English: Adverse reactions reported in subjects aged >55 years were similar to those observed in younger adults.
Croatian: Nuspojave prijavljene u ispitanika u dobi od >55 godina bile su slične onima uočenim u odraslih osoba mlađe dobi.
English: • rash (infants).
Croatian: • osip (dojenčad).
English: However, some of the effects mentioned under section 4.8 “Undesirable effects” may affect the ability to drive or use machines.
Croatian: Međutim, neki od učinaka koji su navedeni u dijelu 4.8 "Nuspojave", mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Local and general adverse reactions
Croatian: Lokalne i opće nuspojave
English: Giving Nimenrix with or one month before a TT-containing vaccine in the second year of life does not impair the response to TT or significantly affect safety.
Croatian: Davanje cjepiva Nimenrix zajedno sa ili mjesec dana prije cjepiva koje sadrži TT u drugoj godini života ne umanjuje odgovor na TT, niti značajno utječe na sigurnost.
English: The safety of Nimenrix presented in the table below is based on two clinical study datasets as follows:
Croatian: Sigurnost cjepiva Nimenrix prikazana u tablici ispod temelji se na dva skupa podataka dobivena u kliničkim ispitivanjima kako je navedeno:
English: Nimenrix may not work as well if you are taking medicines that affect your immune system.
Croatian: Nimenrix može imati slabije djelovanje ako uzimate lijekove koji utječu na imunološki sustav.
English: • Do not use this medicine after the expiry date which is stated on the carton.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Croatian: Uz nju se može javiti nekoliko neuroloških znakova poput prolaznog poremećaja vida, parestezija i toničko-kloničkih pokreta udova tijekom oporavka.
English: Your doctor will tell you if and when you need an additional dose of Nimenrix, especially if you or your child:
Croatian: Vaš će Vam liječnik reći trebate li primiti dodatnu injekciju cjepiva Nimenrix, odnosno kada je trebate primiti, pogotovo ako ste Vi ili Vaše dijete:
English: What Nimenrix looks like and contents of the pack
Croatian: Kako Nimenrix izgleda i sadržaj pakiranja
English: Pharmacotherapeutic group: vaccines, meningococcal vaccines, ATC code: J07AH08
Croatian: Farmakoterapijska skupina: cjepiva, meningokokna cjepiva, ATK oznaka: J07AH08
English: Safety data have also been evaluated in a separate study, in which a single dose of Nimenrix was administered to 274 individuals aged 56 years and older.
Croatian: Podaci o sigurnosti primjene također su bili procijenjeni u zasebnom ispitivanju u kojem je jednokratna doza cjepiva Nimenrix bila primijenjena u 274 pojedinca u dobi od 56 godina i starijih.
English: • A pooled analysis of data from 9,621 subjects administered a single dose of Nimenrix.
Croatian: • Objedinjena analiza podataka za 9621 ispitanika koji su primili jednokratnu dozu Nimenrixa.
English: If you are pregnant, think you may be pregnant, plan to become pregnant or are breast-feeding, you must tell your doctor before receiving Nimenrix.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego što primite Nimenrix.
English: Tell your doctor or nurse if you are taking or have recently taken any other medicines, including other vaccines and medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući druga cjepiva i lijekove koje ste nabavili bez recepta.
English: Other medicines and Nimenrix
Croatian: Drugi lijekovi i Nimenrix
English: Nimenrix is not likely to affect your ability to drive or use machines.
Croatian: Nije vjerojatno da će Nimenrix utjecati na sposobnost vožnje ili upravljanja strojevima.
English: It is unknown whether Nimenrix is excreted in human milk.
Croatian: Nije poznato izlučuje li se Nimenrix u majčino mlijeko.
English: • The other ingredients are: - In the powder: sucrose and trometamol - In the solvent: sodium chloride and water for injections
Croatian: • Drugi sastojci su: - U prašku: saharoza i trometamol - U otapalu: natrijev klorid i voda za injekcije
English: No data are available beyond the age of 2 years.
Croatian: Nema dostupnih podataka u djece nakon 2 godine starosti.
English: It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable effects) and a clinical examination.
Croatian: Dobra klinička praksa je prije cijepljenja pregledati povijest bolesti (osobito obzirom na prethodna cijepljenja i moguće javljanje nuspojava) i obaviti klinički pregled.
English: Similar responses in terms of % with hSBA titre ≥8 were observed with groups A and C (Table 7).
Croatian: Slični odgovori u smislu % s hSBA titrom ≥8 primijećeni su kod grupa A i C (Tablica 7).
English: Check with your doctor or nurse before you receive this vaccine if:
Croatian: Provjerite s liječnikom ili medicinskom sestrom prije nego primite ovo cjepivo:
English: Protection against meningococcal disease
Croatian: Zaštita od meningokokne bolesti
English: Nimenrix is always injected into a muscle, usually in the upper arm or thigh.
Croatian: Nimenrix se uvijek ubrizgava u mišić, obično u nadlakticu ili u bedro.
English: Name and address of the manufacturers of the biological active substance GlaxoSmithKline Biologicals S.A.
Croatian: Nazivi i adrese proizvođača biološke djelatne tvari GlaxoSmithKline Biologicals S.A.
English: In that case, the needle should be attached without screwing.
Croatian: U tom slučaju iglu treba pričvrstiti bez navijanja.
English: Dispose of in accordance with local regulations.
Croatian: Odlagati sukladno nacionalnim propisima.
English: Pack sizes of 1 and 10 with or without needles.
Croatian: Veličine pakiranja od 1 i 10 sa ili bez igala.
English: There was no impact of coadministration on immune responses to the other nine pneumococcal serotypes.
Croatian: Istodobna primjena nije imala utjecaja na imunološki odgovor na preostalih devet pneumokoknih serotipova.
English: Nimenrix may not fully protect everyone who is vaccinated.
Croatian: Nimenrix ne mora u potpunosti zaštititi sve koji su se cijepili.
English: More than 98% of subjects had anti-PT, FHA or PRN concentrations above the assay cut-off thresholds.
Croatian: Više od 98% ispitanika imalo je koncentracije protutijela protiv PT-a, FHA-a ili PRN-a iznad graničnih vrijednosti praga u testovima.
English: To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock (See picture).
Croatian: Pričvrstite iglu na štrcaljku na način da utiskujete iglu okrećući je u smjeru kazaljke na satu dok ne osjetite da je sjela na mjesto (vidjeti sliku).
English: Nimenrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
Croatian: Nimenrix treba primijeniti s oprezom u osoba s trombocitopenijom ili bilo kojim poremećajem zgrušavanja krvi, jer nakon intramuskularne primjene u ovih osoba može doći do krvarenja.
English: Nimenrix helps your body to produce its own protection (antibodies) against the bacteria.
Croatian: Nimenrix pomaže tijelu kako bi ono samo razvilo zaštitu (protutijela) protiv bakterija.
English: See Table 2.
Croatian: Vidjeti Tablicu 2.
English: However, the syringe provided with Nimenrix might be slightly different (without screw thread) than the syringe described in the picture.
Croatian: Doduše, štrcaljka koja je priložena cjepivu Nimenrix može se malo razlikovati (bez vijka) od štrcaljke opisane na slici.
English: A selection bias mainly due to revaccination of subjects with group C rSBA titres <8 and their exclusion from subsequent time-point(s) may have led to an overestimation of the titres.
Croatian: Pristranost pri odabiru, uglavnom zbog docjepljivanja ispitanika s grupa C rSBA titrima <8 i njihovim isključenjem iz sljedeće(ih) vremenske(ih) točke(i), može dovesti do precjenjivanja titara.
English: In infants, the recommended injection site is the anterolateral aspect of the thigh.
Croatian: U dojenčadi preporučeno mjesto injekcije je anterolateralni dio bedra.
English: • crying
Croatian: • plačljivost
English: Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Croatian: Uvijek valja osigurati odgovarajući medicinski tretman i nadzor u slučaju rijetke anafilaktičke reakcije nakon primjene cjepiva.
English: Immunodeficiency
Croatian: Imunodeficijencija
English: Anti-capsular meningococcal antibodies protect against meningococcal diseases via complement mediated bactericidal activity.
Croatian: Antikapsularna meningokokna protutijela pružaju zaštitu od meningokoknih bolesti putem komplementom posredovanog baktericidnog djelovanja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL AND 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 1 VIAL AND 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLE 10 VIALS AND 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU 1 BOČICA I 1 NAPUNJENA ŠTRCALJKA BEZ IGLE 1 BOČICA I 1 NAPUNJENA ŠTRCALJKA S DVIJE IGLE 10 BOČICA I 10 NAPUNJENIH ŠTRCALJKI BEZ IGLE 10 BOČICA
English: Nimenrix should not be mixed with other vaccines.
Croatian: Nimenrix se ne smije miješati s drugim cjepivima.
English: Adverse reactions reported are listed according to the following frequency categories:
Croatian: Prijavljene nuspojave navedene su prema sljedećim kategorijama učestalostima:
English: The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Croatian: Prisutnost blaže infekcije, poput prehlade, ne bi trebala biti razlogom za odgađanje cijepljenja.