FrancophonIA/ELRC3.0 huggingface dataset:
English: Baclofen: fampridine has been administered concomitantly with baclofen and no pharmacokinetic medicinal product interactions were observed.
Croatian: Baklofen: tijekom istodobne primjene fampridina i baklofena nisu opažene farmakokinetičke interakcije lijekova.
English: Adverse reactions identified are mostly neurological and include seizure, insomnia, anxiety, balance disorder, dizziness, paraesthesia, tremor, headache and asthenia.
Croatian: Identificirane nuspojave su uglavnom neurološke naravi i uključuju napadaj, nesanicu, anksioznost, poremećaj ravnoteže, omaglicu, paresteziju, tremor, glavobolju i asteniju.
English: Patients with mild, moderate or severe renal impairment (creatinine clearances <80 ml/min).
Croatian: Bolesnici s blagim, umjerenim ili teškim oštećenjem bubrega (klirensi kreatinina <80 ml/min).
English: Fampyra should be discontinued in patients who experience a seizure while on treatment.
Croatian: Liječenje Fampyrom treba prekinuti u bolesnika koji tijekom liječenja dožive napadaj.
English: Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine).
Croatian: Istodobno uzimanje drugih lijekova koji sadrže fampridin (4-aminopiridin).
English: Fampyra is supplied in either bottles or blister packs.
Croatian: Fampyra je dostupna u bocama ili u blister pakiranjima.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA BOCE
English: Starting and Evaluating Fampyra Treatment
Croatian: Početak liječenja Fampyrom i procjena
English: The primary endpoint was improvement in walking ability, measured as the proportion of patients achieving a mean improvement of ≥ 8 points from baseline MSWS-12 score over 24 weeks.
Croatian: Primarni ishod bio je poboljšanje mogućnosti hodanja mjereno kao udio bolesnika koji je postigao srednju vrijednost poboljšanja ≥ 8 bodova u odnosu na početni rezultat 12-stupanjske ljestvice hodanja kod multiple skleroze (MSWS-12) tijekom 24 tjedna.
English: You must always leave 12 hours between each tablet.
Croatian: Uvijek mora proći 12 sati između uzimanja svake tablete.
English: Balance disorder Paraesthesia
Croatian: Poremećaj ravnoteže
English: Fampyra is supplied in either blister packs or bottles.
Croatian: Fampyra je dostupna u u blister pakiranjima ili bocama.
English: Fampyra is only available by prescription and under the supervision of doctors experienced in MS.
Croatian: Fampyra je dostupna samo na recept i pod nadzorom liječnika iskusnih u liječenju multiple skleroze.
English: If no improvement is observed, Fampyra should be discontinued
Croatian: Ukoliko nije opaženo poboljšanje,
English: • Fampyra should be discontinued if benefit is not reported by patients.
Croatian: • Liječenje Fampyrom treba prekinuti ako bolesnik ne osjeća nikakvo poboljšanje.
English: Acute symptoms of overdose with Fampyra were consistent with central nervous system excitation and included confusion, tremulousness, diaphoresis, seizure, and amnesia.
Croatian: Akutni simptomi predoziranja Fampyrom ukazuju na ekscitaciju središnjeg živčanog sustava i uključuju konfuziju, drhtanje, dijaforezu, napadaje i amneziju.
English: • An assessment of walking ability, e.g. the Timed 25 Foot Walk (T25FW) or Twelve Item Multiple Sclerosis Walking Scale (MSWS-12), is recommended to evaluate improvement within two to four weeks.
Croatian: • Za procjenu poboljšanja mogućnosti hodanja unutar dva do četiri tjedna, preporučuje se procijeniti mogućnost hodanja npr. mjerenjem vremena potrebnog za prijelaz hodne pruge od 7,6 metara (Timed 25 Foot Walk, T25FW) ili 12-stupanjskom ljestvicom hodanja kod multiple skleroze (Multiple Sclerosis Walking Scale, MSWS-12).
English: In a battery of in vitro and in vivo studies fampridine did not show any potential to be mutagenic, clastogenic or carcinogenic.
Croatian: U nizu in vitro i in vivo ispitivanja, fampridin se ni na koji način nije pokazao mutagenim,
English: − Tablet core: hypromellose, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate; film coat: hypromellose, titanium dioxide (E-171), polyethylene glycol 400
Croatian: Jezgra tablete: hipromeloza celuloza, mikrokristalična silicijev dioksid, koloidni, bezvodni magnezijev stearat Film ovojnica: hipromeloza titanijev dioksid (E 171) polietilenglikol 400
English: How to store Fampyra
Croatian: Kako čuvati Fampyru
English: Fampyra comes in foil blisters of 14 tablets each.
Croatian: Fampyra dolazi u blisterima od folije sa 14 tableta.
English: Athlone, Co. Westmeath Ireland
Croatian: Westmeath, Irska
English: Patients with hepatic impairment No dose adjustment is required for patients with hepatic impairment.
Croatian: Za bolesnike s oštećenjem jetre nije potrebno podešavati dozu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S BLISTERIMA
English: − if you have kidney problems
Croatian: − ako imate problema s bubrezima
English: Fampyra is an off-white, film coated, oval biconvex 13 x 8 mm prolonged-release tablet with A10 on one side.
Croatian: Fampyra je gotovo bijela, filmom obložena, ovalna bikonveksna tableta s produljenim oslobađanjem dimenzija 13 x 8 mm s utisnutom oznakom A10 na jednoj strani.
English: You must leave 12 hours between each tablet.
Croatian: Mora proći 12 sati između uzimanja svake tablete.
English: Rash Urticaria
Croatian: Osip Urtikarija
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2)
English: Viral infection1
Croatian: Nazofaringitis1 Virusna infekcija1
English: • Sore throat
Croatian: • Bolno grlo
English: Clinical signs evident after large single doses or repeated lower doses were similar in all species studied and included tremors, convulsions, ataxia, dyspnoea, dilated pupils, prostration, abnormal vocalization, increased respiration, and excess salivation.
Croatian: Klinički znakovi očiti nakon velike pojedinačne doze ili ponavljane niže doze su bili slični u svim ispitivanim vrstama, a uključili su tremor, konvulzije, ataksiju, dispneju,
English: Very Common Common
Croatian: Vrlo česte nuspojave
English: Each pack contains 28 tablets (2 bottles) or 56 tablets (4 bottles).
Croatian: Jedno pakiranje sadrži 28 tableta (2 boce) ili 56 tableta (4 boce).
English: Fampyra is contraindicated in patients with mild, moderate and severe renal impairment (creatinine clearances <80 ml/min) (see section 4.3).
Croatian: Fampyra je kontraindicirana u bolesnika s blagim, umjerenim ili teškim oštećenjem bubrega (klirensi kreatinina <80 ml/min) (vidjeti dio 4.3).
English: Dyspnoea Pharyngolaryngeal pain
Croatian: Faringolaringealna bol
English: Biogen GmbH Tel: +49 (0) 89 99 6170
Croatian: Tel: +49 (0) 89 99 6170
English: • Fast heart rate (tachycardia)
Croatian: • Ubrzan rad srca (tahikardija) Prijavljivanje nuspojava
English: Τηλ: +30 210 8771500
Croatian: Genesis Pharma SA Τηλ: +30 210 8771500
English: Package leaflet: information for the user Fampyra 10mg prolonged-release tablets fampridine
Croatian: Uputa o lijeku: Informacije za korisnika Fampyra 10mg tablete s produljenim oslobađanjem fampridin
English: Caution is required when Fampyra is prescribed concurrently with medicinal products that are substrates of OCT2 for example, carvedilol, propanolol and metformin.
Croatian: Potreban je oprez kad se Fampyra propisuje istodobno s lijekovima koji su supstrat transportera organskih kationa (OCT2), primjerice karvedilolom, propranololom i metforminom.
English: • Common cold (nasopharyngitis)
Croatian: • Obična prehlada (nazofaringitis)
English: Studies MS-F203 and MS-F204
Croatian: Ispitivanja MS-F203 i MS-F204
English: • Feeling weak and tired
Croatian: • Osjećaj slabosti i umora
English: Gait abnormalities and hyper-excitability were also observed.
Croatian: Također su opaženi poremećaji hoda i pretjerana razdražljivost.
English: Fampyra is a potassium channel blocker.
Croatian: Fampyra je blokator ionskih kanala za kalij.
English: Fampyra must not be administered to patients with mild, moderate and severe renal impairment (see section 4.3).
Croatian: Fampyra se ne smije primjenjivati u bolesnika s blagim, umjerenim i teškim oštećenjem bubrežne funkcije (vidjeti dio 4.3).
English: Table 1: Studies MS-F203 and MS-F204 STUDY *
Croatian: Tablica 1: Ispitivanja MS-F203 i MS-F204
English: 28 prolonged-release tablets (2 blisters of 14 tablets each) 56 prolonged-release tablets (4 blisters of 14 tablets each)
Croatian: 28 tableta s produljenim oslobađanjem (2 blistera svaki s 14 tableta) 56 tableta s produljenim oslobađanjem (4 blistera svaki s 14 tableta)
English: Nausea Vomiting Constipation Dyspepsia
Croatian: Poremećaji probavnog sustava Mučnina Povraćanje
English: HDPE (high-density polyethylene) bottle with polypropylene caps, each bottle contains 14 tablets and a silica gel desiccant.
Croatian: Boce Boce od HDPE (polietilen visoke gustoće) s polipropilenskim zatvaračem, svaka boca sadrži
English: The Fampyra dose was 10 mg BID.
Croatian: Doza Fampyre je bila 10 mg dva puta na dan.
English: 28 prolonged-release tablets (2 bottles of 14 tablets each) 56 prolonged-release tablets (4 bottles of 14 tablets each)
Croatian: 28 tableta s produljenim oslobađanjem (2 boce svaka s 14 tableta) 56 tableta s produljenim oslobađanjem (4 boce svaka s 14 tableta)
English: In addition, patients treated with Fampyra demonstrated a statistically significant mean improvement from baseline compared to placebo in the Multiple Sclerosis Impact Scale (MSIS-29) physical score (LSM difference -3.31, p<0.001).
Croatian: Nadalje, bolesnici liječeni Fampyrom pokazali su statistički značajnu srednju vrijednost poboljšanja u odnosu na početnu vrijednost u usporedbi s placebom u fizičkom rezultatu ljestvice za mjerenje utjecaja multiple skleroze (engl.
English: Pack size of 56 (4 bottles of 14) tablets.
Croatian: Veličina pakiranja od 56 (4 boce od 14) tableta.
English: Fampyra is not recommended during breast-feeding.
Croatian: Tijekom dojenja ne preporučuje se uzimanje Fampyre.
English: The 3-hydroxylation of fampridine to 3-hydroxy-4-aminopyridine by human liver microsomes appeared to be catalyzed by Cytochrome P450 2E1 (CYP2E1).
Croatian: Čini se da citokrom P450 2E1 (CYP2E1) mikrosoma ljudske jetre katalizira 3-hidroksilaciju fampridina u 3-hidroksi-4-aminopiridin.
English: Pack size of 28 (2 bottles of 14) tablets.
Croatian: Veličina pakiranja od 28 (2 boce od 14) tableta.
English: EU/1/11/699/003 28 tablets EU/1/11/699/004 56 tablets
Croatian: EU/1/11/699/004 56 tableta
English: Each pack contains 28 tablets (2 blisters) or 56 tablets (4 blisters).
Croatian: Jedno pakiranje sadrži 28 tableta (2 blistera) ili 56 tableta (4 blistera).
English: EU/1/11/699/001 28 tablets EU/1/11/699/002 56 tablets
Croatian: EU/1/11/699/002 56 tableta
English: Seizure risk
Croatian: Rizik pojave napadaja
English: Fampyra 10 mg BID N = 315*
Croatian: N = 315*
English: In patients with renal impairment, accumulation occurs relative to the degree of impairment.
Croatian: U bolesnika s oštećenjem bubrežne funkcije se nakupljanje pojavljuje srazmjerno stupnju oštećenja.
English: Hypromellose Microcrystalline cellulose Silica, colloidal anhydrous Magnesium stearate
Croatian: Jezgra tablete: hipromeloza, mikrokristalična celuloza, silicijev dioksid koloidni, bezvodni,
English: Proportion of patients with mean improvement of ≥ 8
Croatian: Udio bolesnika sa srednjom vrijednošću poboljšanja
English: Pack size of 56 (4 blisters of 14) tablets.
Croatian: Veličina pakiranja od 56 (4 blistera od 14) tableta.
English: This may increase your risk of serious side effects Tell your doctor and do not take Fampyra if any of these apply to you.
Croatian: Obavijestite svog liječnika i ne uzimajte Fampyru ako se bilo što od ovog odnosi na Vas.
English: Pack size of 28 (2 blisters of 14) tablets.
Croatian: Veličina pakiranja od 28 (2 blistera od 14) tableta.
English: Baseline 69.27 (2.22) Average change -0.01 (1.46) Difference p-value LEMMT (mean, sem) (Lower Extremity Manual Muscle Test) Baseline 3.92 (0.070) Average change 0.05 (0.024) Difference p-value Ashworth Score (A test for muscle spasticity)
Croatian: Početno 69,27 (2,22) Prosječna promjena -0,01 (1,46) Razlika p-vrijednost
English: As a precautionary measure it is preferable to avoid the use of Fampyra in pregnancy.
Croatian: Oprez nalaže da se primjena Fampyre tijekom trudnoće izbjegava, ako je to moguće.
English: Treatment with Fampyra is restricted to prescription and supervision by physicians experienced in the management of MS.
Croatian: Fampyra se izdaje samo na ograničeni liječnički recept, a liječenje treba nadzirati liječnik iskusan u liječenju multiple skleroze.
English: Fampyra should not be administered to patients with renal impairment (creatinine clearance <80 ml/min) (see section 4.3).
Croatian: Fampyra se ne smije primjenjivati u bolesnika s oštećenjem bubrega (klirens kreatinina <80 ml/min)
English: − Each prolonged-release tablet contains 10 mg of fampridine
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 10 mg fampridina
English: • Heartbeat that you can feel (palpitations)
Croatian: • Osjećaj lupanja srca (palpitacije)
English: leave 12 hours between each tablet
Croatian: Mora proći 12 sati između uzimanja tableta
English: Biogen Idec Limited Tel: +44 (0) 1628 50 1000
Croatian: Tel: +44 (0) 1628 50 1000
English: Improvement from baseline (sec)
Croatian: Poboljšanje u odnosu na početak (sek)
English: Baseline Endpoint Change Difference p-value Average % Change Difference p-value MSWS-12-score (mean, sem)
Croatian: Prosječni % promjene Razlika p-vrijednost
English: points from baseline MSWS-12 score
Croatian: ≥ 8 bodova u odnosu na početni rezultat MSWS-12
English: Fampyra 10 mg prolonged-release tablets fampridine
Croatian: Fampyra 10 mg tablete s produljenim oslobađanjem fampridin
English: Fampyra 10 mg BID
Croatian: Fampyra 10 mg dva puta na dan
English: • Feeling unsteady
Croatian: • Osjećaj nestabilnosti • Omaglica
English: What Fampyra looks like and contents of the pack
Croatian: Što Fampyra sadrži
English: Three phase III, randomised, double-blind, placebo controlled confirmatory studies, (MS-F203 and MS-F204 and 218MS305) have been performed.
Croatian: (MS-F203, MS-F204 i 218MS305).
English: Patients with renal impairment:
Croatian: Bolesnici s oštećenjem bubrežne funkcije:
English: Fampyra is for oral use.
Croatian: Fampyra se uzima kroz usta.
English: Hypromellose Titanium dioxide (E-171) Polyethylene glycol 400
Croatian: magnezijev stearat; film ovojnica: hipromeloza, titanijev dioksid (E-171), polietilenglikol 400 Kako Fampyra izgleda i sadržaj pakiranja
English: • Anxiety
Croatian: Anksioznost
English: Prolonged-release tablet.
Croatian: OBLIK Tableta s produljenim oslobađanjem.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 14 tableta s produljenim oslobađanjem
English: Each prolonged-release tablet contains 10 mg of fampridine.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 10 mg fampridina.
English: Fampyra 10 mg prolonged-release tablets
Croatian: NAZIV LIJEKA Fampyra 10 mg tablete s produljenim oslobađanjem
English: Monitoring renal function to detect any renal impairment is recommended in older people (see section 4.4).
Croatian: U starijih osoba preporučuje se nadziranje bubrežne funkcije za otkrivanje bilo kojih oštećenja bubrega (vidjeti dio
English: Difference
Croatian: Promjena
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Nasopharyngitis1
Croatian: Influenca1
English: Marketing Authorisation Holder and Manufacturer
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet:
English: Τηλ: +357 22 765740
Croatian: Genesis Pharma (Cyprus) Ltd Τηλ: +357 22 765740
English: Baseline
Croatian: Sri Čet
English: Consistent improvement
Croatian: Poboljšanje u odnosu na početak
English: Biogen Netherlands B.V. Tel: +31 20 542 2000
Croatian: Biogen Poland Sp. z o.o. Tel.: +48 22 351 51 00
English: ANNEX II A. MANUFACTURERS(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET • Periodička izvješća o neškodljivosti lijeka (PSUR-evi)
English: Tremor
Croatian: Konstipacija
English: What Fampyra contains − The active substance is fampridine.
Croatian: Djelatna tvar je fampridin.
English: Genesis Pharma SA
Croatian: Biogen GmbH
English: EXPIRY DATE
Croatian: Početno Na ishodu
English: Immune system disorders
Croatian: • Infekcija mokraćnog sustava
English: • Constipation
Croatian: • Povraćanje
English: The vaccine is given as an injection into the shoulder muscle.
Croatian: Cjepivo se daje kao injekcija u rameni mišić.
English: This compared with 56 of the more than 7,000 women who received the other vaccine.
Croatian: To je uspoređeno s 56 od više od 7 000 žena koje su primile drugo cjepivo.
English: The full EPAR for Cervarix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Cervarix nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The antibodies help to destroy the virus.
Croatian: Protutijela pomažu u uništavanju virusa.
English: Cervarix is given as two or three doses depending on age.
Croatian: Cervarix se daje u dvije ili tri doze, ovisno o dobi.
English: The women were followed up for up to four years after the first dose of the vaccines.
Croatian: Žene su praćene u razdoblju do četiri godine nakon prve doze cjepiva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cervarix on 20 September 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Cervarix na snazi u Europskoj uniji od 20. rujna 2007.
English: This will help to protect against the diseases caused by these viruses.
Croatian: To pomaže u zaštiti od bolesti koje uzrokuju virusi.
English: It is a suspension for injection that contains purified proteins for two types of the human papillomavirus (types 16 and 18).
Croatian: To je suspenzija za injekciju koja sadrži pročišćene proteine za dva tipa humanog papilomavirusa (tipove 16 i 18).
English: Cervarix is used in males and females from the age of 9 years to protect against the following conditions caused by certain types of the human papillomavirus (HPV):
Croatian: Cervarix se koristi u muških i ženskih osoba od 9 i više godina za prevenciju sljedećih stanja uzrokovanih specifičnim tipovima humanog papilomavirusa (HPV):
English: After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses.
Croatian: Nakon cijepljenja imunosni sustav može brže proizvoditi protutijela kada je izložen stvarnim virusima.
English: A similar study was carried out in girls aged 9 to 14 years of age.
Croatian: Slično je ispitivanje provedeno na djevojkama od 9 do 14 godina.
English: If necessary, the second dose can be given between 5 and 13 months after the first dose.
Croatian: Ako je potrebno, druga se doza može dati između 5 i 13 mjeseci nakon prve doze.
English: What measures are being taken to ensure the safe and effective use of Cervarix?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cervarix?
English: Cervarix is given according to official recommendations.
Croatian: Cjepivo Cervarix primjenjuje se u skladu sa službenim preporukama.
English: • precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva, vagina or anus).
Croatian: • premalignih lezija (abnormalnog rasta stanica) na genitalnom području (cerviks, vulva, vagina ili anus).
English: Papillomaviruses are viruses that cause warts and abnormal tissue growth.
Croatian: Papilomavirusi su virusi koji uzrokuju bradavice i abnormalan rast tkiva.
English: It is recommended that individuals who receive the first dose of Cervarix should complete the course of vaccination.
Croatian: Preporučuje se da osobe koje prime prvu dozu lijeka Cervarix završe tijek cijepljenja.
English: Other information about Cervarix
Croatian: Ostale informacije o lijeku Cervarix
English: There are more than 100 types of papillomavirus, some of which are associated with genital and anal cancers.
Croatian: Postoji više od 100 tipova papilomavirusa, od kojih su neki povezani s karcinomima genitalnih organa i anusa.
English: People aged 9 to 14 years can be given two doses, six months apart.
Croatian: Osobe u dobi od 9 do 14 godina mogu primiti dvije doze u razmaku od šest mjeseci.
English: For more information about treatment with Cervarix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Cervarix pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
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 Cervarix.
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 o uvjetima za primjenu lijeka Cervarix.
English: For the prevention of precancerous lesions or cancer of the cervix, Cervarix has been investigated in one main study involving almost 19,000 women aged between 15 and 25 years.
Croatian: U pogledu prevencije premalignih lezija ili raka cerviksa, cjepivo Cervarix ispitano je u jednom glavnom ispitivanju koje je obuhvatilo gotovo 19 000 žena u dobi između 15 i 25 godina.
English: HPV types 16 and 18 cause approximately 70% of cervical cancers and 90% of anal cancers.
Croatian: Tipovi HPV-a 16 i 18 uzrokuju otprilike 70 % rakova grlića maternice te 90 % rakova anusa.
English: Cervarix contains purified L1 proteins for HPV types 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by cells into which a gene (DNA) has been introduced that makes the cells able to produce the L1 proteins.
Croatian: Cjepivo Cervarix sadrži pročišćene L1 proteine za tipove HPV-a 16 i 18, koji su proizvedeni metodom „tehnologije rekombinantne DNK”: proizvode ih stanice u koje je unesen gen (DNK) koji stanicama omogućuje stvaranje L1 proteina.
English: Cervarix is a vaccine.
Croatian: Cervarix je cjepivo.
English: The most common side effects with Cervarix (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection including pain, redness and swelling, and fatigue (tiredness).
Croatian: Najčešće nuspojave lijeka Cervarix (uočene u više od 1 na 10 bolesnika) su glavobolja, mialgija (bol u mišićima), reakcije na mjestu injekcije, uključujući bol, crvenilo i oticanje te iscrpljenost (umor).
English: This document is a summary of the European public assessment report (EPAR) for Cervarix.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni dokumentacije (EPAR) o lijeku Cervarix.
English: People aged 15 and above are given three doses.
Croatian: Osobama u dobi od 15 i više godina daju se tri doze.
English: Cervarix human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Croatian: Cervarix cjepivo protiv humanog papilomavirusa [tipova 16, 18] (rekombinantno, adsorbirano, s adjuvansom)
English: The studies looking at the levels of antibodies in males showed that their levels were similar to those in females.
Croatian: Ispitivanja u kojima su istražene razine protutijela u muškaraca pokazala su da su njihove razine bile slične onima u žena.