FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use any other sort of water.
Croatian: Ne koristite nikakvu drugu vrstu vode.
English: The effect of the medicine will last for longer.
Croatian: Učinak lijeka trajat će dulje.
English: • This medicine is only for you - do not let anyone else use it.
Croatian: • Ovaj lijek je samo za Vas - nemojte dopustiti da ga koristi itko drugi.
English: Lay out everything you need on a clean surface:
Croatian: Pripremite sve što trebate na čistu površinu:
English: Unopened vial: 2 years
Croatian: Neotvorena bočica: 2 godine
English: Wash your hands • It is important that your hands and the things you use are as clean as possible.
Croatian: Operite ruke • Važno je da Vaše ruke i predmeti koje koristite budu što čišći.
English: • Your doctor must supervise your first injection.
Croatian: • Liječnik mora nadzirati Vašu prvu injekciju.
English: • Hold the syringe in one hand - like you would hold a pencil.
Croatian: • Držite štrcaljku u jednoj ruci - kao što biste držali olovku.
English: You can choose to inject every morning or every evening.
Croatian: Možete odabrati injiciranje svako jutro ili svaku večer.
English: DATE OF REVISION OF THE TEXT {DD/MM/YYYY}
Croatian: DATUM REVIZIJE TEKSTA {DD/MM/GGGG}
English: Bad effects are not expected if you accidentally inject more of this medicine than you should.
Croatian: Ne očekuju se loši učinci ako slučajno injicirate više ovog lijeka nego što ste trebali.
English: Your doctor or nurse will show you how to prepare and inject the medicine.
Croatian: Vaš liječnik ili medicinska sestra pokazat će Vam kako pripremiti i injicirati lijek.
English: It is best to use the medicine at the same time each day, leaving 24 hours between each dose.
Croatian: Najbolje je koristiti lijek u isto vrijeme svakog dana, s razmakom od 24 sata između dvije doze.
English: Based on your ovarian response, your doctor may decide to start on another day.
Croatian: Na temelju odgovora Vaših jajnika, liječnik može odlučiti da počnete neki drugi dan.
English: • Do not inject a double dose to make up for a forgotten dose.
Croatian: • Nemojte injicirati dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: After reconstitution: use immediately
Croatian: Nakon rekonstitucije: primijeniti odmah
English: Do not use Cetrotide if any of the above applies to you.
Croatian: Nemojte primjenjivati Cetrotide ako se bilo što od gore navedenog odnosi na Vas.
English: Store in a refrigerator (2°C - 8°C).
Croatian: Čuvati u hladnjaku (2C - 8C).
English: Administration in the morning
Croatian: Primjena ujutro
English: The adverse reactions reported below are classified according to frequency of occurrence as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Croatian: Nuspojave navedene u daljnjem tekstu klasificirane su prema sljedećoj učestalosti pojavljivanja: 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).
English: If you use more Cetrotide than you should
Croatian: Ako primijenite više Cetrotida nego što ste trebali
English: If blood appears, follow Step 5 below.
Croatian: U slučaju pojave krvi, slijedite korak 5 u nastavku.
English: During or after you receive these medicines, you may develop OHSS.
Croatian: Tijekom ili nakon primanja ovih lijekova možete razviti OHSS.
English: Distribution The volume of distribution (Vd) is 1.1 L x kg
Croatian: Distribucija Volumen distribucije (Vd) iznosi 1,1 l x kg
English: Date of latest renewal: 13 April 2009
Croatian: Datum posljednje obnove odobrenja: 13. travnja 2009.
English: This event must be considered as an intrinsic risk of the stimulation procedure with gonadotropins
Croatian: Ovaj se događaj mora uzeti u obzir kao intrinzični rizični čimbenik za postupak stimulacije gonadotropinima.
English: Congenital anomalies
Croatian: Kongenitalne anomalije
English: However, the possibility of interactions with gonadotropins or medicinal products that may induce histamine release in susceptible individuals, cannot be totally excluded.
Croatian: No, mogućnost interakcija s gonadotropinima ili lijekovima koji mogu inducirati oslobađanje histamina u osjetljivih osoba ne može se u potpunosti isključiti.
English: To reduce skin irritation, select a different part of your belly each day.
Croatian: Kako biste umanjili iritaciju kože, odaberite različit dio Vašeg trbuha svaki dan.
English: Do not use this medicine if you notice that the white powder in the vial has changed in appearance.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je bijeli prašak u bočici promijenio izgled.
English: This is because if the eggs are released too early (premature ovulation) it may not be possible for your doctor to collect them.
Croatian: To je bitno jer ako se jajne stanice oslobađaju prerano (prerana ovulacija), možda ih Vaš liječnik neće moći sakupiti.
English: • Please carefully read and follow the instructions at the end of this leaflet called ‘How to mix and inject Cetrotide'.
Croatian: • Pažljivo pročitajte upute na kraju ovog lista pod naslovom „Kako miješati i injicirati Cetrotide“
English: • Do not touch the grey needle and do not let the needle touch any surface.
Croatian: • Ne dirajte sivu iglu i nemojte dozvoliti da igla dotakne površinu.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier code 18.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: • LH stimulates ovulation during your menstrual cycle.
Croatian: • LH stimulira ovulaciju tijekom vašeg menstrualnog ciklusa.
English: No teratogenic effects occurred when the medicinal product was administered during the sensitive phase of gestation.
Croatian: Nije bilo nikakvih teratogenih učinaka kada se lijek primjenjivao za vrijeme osjetljive faze gestacije.
English: • empty your medicine into a sink and follow Step 6 below
Croatian: • ispraznite svoj lijek u slivnik i slijedite korak 6 u nastavku
English: Overdosage in humans may result in a prolonged duration of action but is unlikely to be associated with acute toxic effects.
Croatian: Predoziranje u ljudi može dovesti do produljenog trajanja učinka, ali nije vjerojatno da će uzrokovati akutne toksične učinke.
English: Pregnancy and breast-feeding Cetrotide is not intended to be used during pregnancy and lactation (see section 4.3).
Croatian: Trudnoća i dojenje Cetrotide nije namijenjen primjeni tijekom trudnoće i dojenja (vidjeti dio 4.3).
English: Cetrotide is one of the medicines used during ‘assisted reproductive techniques' to help you get pregnant.
Croatian: Cetrotide je jedan od lijekova koji se koristi tijekom „metoda potpomognute oplodnje“ kako bi Vam se pomoglo zatrudnjeti.
English: Do not freeze or place next to the freezer compartment or a freezer pack.
Croatian: Ne zamrzavati ili stavljati u hladnjak blizu pretinca za zamrzavanje ili uloška za hlađenje.
English: In animals as well as in humans, the antagonistic hormonal effects of cetrorelix were fully reversible after termination of treatment.
Croatian: U životinja, kao i u ljudi, antagonistički su hormonski učinci cetroreliksa bili u potpunosti reverzibilni nakon završetka liječenja.
English: Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo-allergic reaction to the injection.
Croatian: Nakon prve primjene, uputno je pacijenticu zadržati pod liječničkim nadzorom 30 minuta kako bi bili sigurni da nema alergijskih/pseudoalergijskih reakcija na injekciju lijeka.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne toksičnosti.
English: If you look from the side through the gap in the rubber stopper, you can control the movement of the needle and the liquid.
Croatian: Ako pogledate sa strane kroz prorez u čepu, možete kontrolirati kretnje igle i tekućine.
English: • wash your hands and start again with a new vial and pre-filled syringe.
Croatian: • operite ruke i počnite ponovno s novom bočicom i napunjenom štrcaljkom.
English: • Before starting to use this medicine, please read these instructions the whole way through first.
Croatian: • Prije početka primjene ovog lijeka, prvo pažljivo pročitajte cijelu uputu.
English: What Cetrotide is and what it is used for What you need to know before you use Cetrotide How to use Cetrotide
Croatian: Što je Cetrotide i za što se koristi Što morate znati prije nego počnete primjenjivati Cetrotide Kako primjenjivati Cetrotide
English: In clinical trials Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicle-stimulating hormone (FSH) suggested similar efficacy.
Croatian: U kliničkim se istraživanjima Cetrotide koristio s humanim menopauzalnim gonadotropinom (HMG), no ograničeno iskustvo s rekombinantnim folikulostimulirajućim hormonom (FSH) upućivalo je na sličnu djelotvornost.
English: • if you are allergic to cetrorelix or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na cetroreliks ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • if you are allergic to medicines similar to Cetrotide (any other peptide hormones).
Croatian: • ako ste alergični na lijekove slične lijeku Cetrotide (bilo koji drugi peptidni hormoni)
English: • Ask your pharmacist how to safely dispose of used needles, vial and syringe.
Croatian: • Pitajte svog ljekarnika kako na siguran način ukloniti korištene igle, bočicu i štrcaljku.
English: • Choose an injection site on your belly.
Croatian: • Izaberite mjesto injekcije na svom trbuhu.
English: Children and adolescents Cetrotide is not indicated for the use in children and adolescents.
Croatian: Djeca i adolescenti Primjena lijeka Cetrotide nije indicirana u djece i adolescenata.
English: Ovarian Hyperstimulation Syndrome (OHSS) This may occur due to the other medicines that you are using to stimulate your ovaries.
Croatian: Sindrom hiperstimulacije jajnika (OHSS) Ovaj sindrom može nastati zbog drugih lijekova koji se koriste za stimulaciju Vaših jajnika.
English: Cetrorelix showed no mutagenic or clastogenic potential in gene and chromosome mutation assays.
Croatian: Cetroreliks nije pokazao mutageni ili klastogeni potencijal u testovima mutacije gena i kromosoma.
English: Using Cetrotide during more than one cycle
Croatian: Primjena lijeka Cetrotide u više od jednog ciklusa
English: What Cetrotide is and what it is used for
Croatian: Što je Cetrotide i za što se koristi
English: In case you pulled out the plunger with the plunger stopper by mistake, make sure to discard the dose as sterility will be lost, and prepare a new dose (and restart from step 1).
Croatian: U slučaju da greškom izvučete klip s gumenim čepom klipa, obavezno bacite tu dozu jer više nije sterilna i pripremite novu dozu (krenite ispočetka od 1. koraka).
English: Cetrorelix is not to be used in the presence of any of the conditions listed below:
Croatian: Cetroreliks se ne smije primjenjivati u slučaju da je prisutno neko od sljedećih stanja:
English: • If you forget a dose, inject it as soon as you remember and talk to your doctor.
Croatian: • Ako ste zaboravili dozu, injicirajte čim je prije moguće i obratite se svom liječniku.
English: • Use each needle, vial and syringe only once.
Croatian: • Svaku iglu, štrcaljku i bočicu upotrijebite samo jedanput.
English: • This section tells you how to mix the powder and the sterile water (solvent) together and then how to inject your medicine.
Croatian: • Ovaj odjeljak sadrži informacije o tome kako miješati prašak i sterilnu vodu (otapalo) skupa te kako ćete injicirati svoj lijek.
English: Appearance of the powder: white lyophilisate Appearance of the solvent: clear and colourless solution The pH of the reconstituted solution is 4.0-6.0.
Croatian: Izgled praška: bijeli liofilizat Izgled otapala: bistra i bezbojna otopina pH otopine nakon rekonstitucije je 4,0-6,0.
English: • Make sure that you collect all of your medicine from the vial.
Croatian: • Pobrinite se da izvučete sav lijek iz bočice.
English: What you need to know before you use Cetrotide
Croatian: Što morate znati prije nego počnete primjenjivati Cetrotide
English: • To remove air bubbles, gently flick the syringe until all the air collects at the top - then slowly push the plunger in until the air bubbles are gone.
Croatian: • Kako biste uklonili mjehuriće zraka lagano tapkajte štrcaljku dok se sav zrak ne skupi na vrhu - potom nježno pogurajte klip sve dok ne nestanu mjehurići zraka.
English: Allergic reactions - Warm, red skin, itching (often in your groin or armpits), red, itchy, raised areas (hives), runny nose, fast or uneven pulse, swelling of your tongue and throat, sneezing, wheezing or serious difficulty breathing, or dizziness.
Croatian: • Topla, crvena koža sa svrbežom (često u području prepona ili pazuha), crvena, svrbljiva, uzdignuta područja (koprivnjača), curenje iz nosa, brz ili nejednak puls, oticanje jezika i grla, kihanje, otežano disanje ili ozbiljne poteškoće u disanju ili omaglica.
English: Pharmacotherapeutic group: anti-gonadotropin-releasing hormones, ATC code: H01CC02.
Croatian: Farmakoterapijska skupina: hormoni inhibitori oslobađanja gonadotropina, ATK oznaka: H01CC02.
English: Using this medicine This medicine is only for injection just under the skin of your belly (subcutaneous).
Croatian: Ovaj je lijek namijenjen samo za injiciranje pod kožu Vašeg trbuha (potkožno).
English: Powder Mannitol
Croatian: Prašak manitol
English: In vitro investigations have shown that interactions are unlikely with medicinal products that are metabolised by cytochrome P450 or glucuronised or conjugated in some other way.
Croatian: In vitro istraživanja pokazala su da nisu vjerojatne interakcije s lijekovima koji se metaboliziraju putem citokroma P450 ili se glukuronidiraju, ili na bilo koji drugi način konjugiraju.
English: Cetrotide should only be prescribed by a specialist experienced in this field.
Croatian: Cetrotide smije propisivati samo liječnik specijalist s iskustvom u ovom području medicine.
English: Remove from the refrigerator approximately 30 minutes before use.
Croatian: Izvadite ga iz hladnjaka približno 30 minuta prije primjene.
English: It should be removed from the refrigerator approximately 30 minutes before use.
Croatian: Treba ga izvaditi iz hladnjaka približno 30 minuta prije primjene.
English: • During pregnancy and lactation.
Croatian: • Tijekom trudnoće i dojenja.
English: The onset of suppression is virtually immediate and is maintained by continuous treatment, without initial stimulatory effect.
Croatian: Početak supresijskog djelovanja je praktički trenutan te se održava kontinuiranom primjenom, bez početnog stimulacijskog učinka.
English: This medicine stops your body from releasing an egg from your ovary (ovulation) during your menstrual cycle.
Croatian: Ovaj lijek sprječava tijelo u otpuštanju jajne stanice iz jajnika (ovulacija) tijekom Vašeg menstrualnog ciklusa.
English: Cetrotide contains a medicine called ‘cetrorelix'.
Croatian: Cetrotide sadrži lijek zvan „cetroreliks“.
English: An OHSS should be treated symptomatically, e.g. with rest, intravenous electrolytes/colloids and heparin therapy.
Croatian: Liječenje OHSS-a treba biti simptomatsko, na primjer, mirovanje, intravenska primjena elektrolita/koloida i terapija heparinom.
English: Limited data from clinical follow-up studies in 316 newborns of women administered cetrorelix for infertility treatments suggest that cetrorelix does not increase the risk of congenital anomalies in the offsprings.
Croatian: Ograničeni podaci iz kliničkih ispitivanja u kojima se pratilo 316 novorođenčadi žena kojima se primjenjivao cetroreliks zbog liječenja neplodnosti pokazuju da cetroreliks ne povećava rizik od kongenitalnih anomalija u potomaka.
English: EXP After reconstitution, use immediately.
Croatian: EXP Nakon rekonstitucije odmah primijeniti.
English: HOW TO MIX AND INJECT CETROTIDE
Croatian: KAKO MIJEŠATI I INJICIRATI CETROTIDE
English: When your eggs are ready to be collected, another medicine will be given to you that will release them (ovulation induction).
Croatian: Kad su jajne stanice spremne za prikupljanje, dobit ćete drugi lijek koji će potaknuti njihovo otpuštanje (indukcija ovulacije).
English: You may be having a possible serious, life-threatening allergic reaction to the medicine.
Croatian: Možete imati ozbiljne, po život opasne alergijske reakcije na lijek.
English: The starting day of Cetrotide is depending on the ovarian response, i.e. the number and size of growing follicles and/or the amount of circulating oestradiol.
Croatian: Prvi dan primjene lijeka Cetrotide ovisi o odgovoru jajnika, tj. o broju i veličini folikula koji se razvijaju i/ili količini estradiola u cirkulaciji.
English: • If no blood appears, slowly push the plunger in to inject your medicine.
Croatian: • Ako nema krvi, polako pogurajte klip kako biste injicirali lijek.
English: - The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty breathing or fluid in your stomach or chest.
Croatian: • OHSS može postati težak s jasno uvećanim jajnicima, smanjenim stvaranjem mokraće, dobivanjem na težini, poteškoćama pri disanju te nakupljanjem tekućine u trbuhu ili prsnom košu.
English: If you forget to use Cetrotide
Croatian: Ako ste zaboravili primijeniti Cetrotide
English: • Put the cap back on the needles so that they are safe to be thrown away.
Croatian: • Vratite poklopac na igle kako bi se mogle ukloniti na siguran način.
English: The entire contents of the vial should be withdrawn to ensure a delivery to the patient of a dose of at least 0.23 mg cetrorelix.
Croatian: Potrebno je izvući sav sadržaj bočice kako bi se osiguralo da pacijentica primi dozu od najmanje 0,23 mg cetroreliksa.
English: Allergies Tell your doctor before using Cetrotide if you have an active allergy or have had allergies in the past.
Croatian: Obavijestite svog liječnika prije primjene lijeka Cetrotide ako imate aktivnu alergijsku reakciju ili ste u prošlosti bili alergični.
English: Do not use Cetrotide
Croatian: Nemojte primjenjivati Cetrotide
English: Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.
Croatian: Prevencija prerane ovulacije u pacijentica kod kojih se primjenjuje postupak kontrolirane stimulacije jajnika, nakon čega slijede sakupljanje oocita i metode asistirane reprodukcije.
English: At a dose of 0.25 mg per injection repeated injections every 24 hours will maintain the effect of cetrorelix.
Croatian: Pri dozi od 0,25 mg po injekciji, injekcije ponavljane svaka 24 sata održavat će učinak cetroreliksa.
English: The prevalence of congenital anomalies after the use of assisted reproductive technologies (ART) with or without GnRH antagonists may be slightly higher than after spontaneous conceptions although it is unclear whether this is related to factors inherent to the couple's infertility or the ART procedures.
Croatian: Prevalencija kongenitalnih anomalija nakon primjene medicinski potpomognute oplodnje (MPO) s antagonistima GnRH-a ili bez njih može biti nešto viša nego nakon spontanog začeća, iako nije jasno je li to povezano s čimbenicima svojstvenima neplodnosti nekog para ili postupcima MPO.
English: • You start by using another medicine on day 1 of your treatment cycle.
Croatian: • S primjenom drugog lijeka počinjete prvog dana Vašeg ciklusa liječenja.
English: Absorption The absolute bioavailability of cetrorelix after subcutaneous administration is about 85%.
Croatian: Apsorpcija Apsolutna bioraspoloživost cetroreliksa je nakon supkutane primjene oko 85%.
English: Treatment with Cetrotide is not advised in women with severe allergic conditions.
Croatian: Liječenje lijekom Cetrotide ne preporučuje se ženama s teškim alergijskim stanjima.
English: Studies in animals have indicated that cetrorelix exerts a dose related influence on fertility, reproductive performance and pregnancy.
Croatian: Istraživanja na životinjama pokazala su da cetroreliks, ovisno o dozi, utječe na plodnost, izvođenje seksualnog čina i trudnoću.
English: Inject the contents of one vial (0.25 mg Cetrotide) once each day.
Croatian: Injicirajte sadržaj jedne bočice (0,25 mg Cetrotide) jednom svakog dana.
English: The injection site reactions may be minimised by rotating the injection sites, delaying injection at the same site and injecting the medicinal product in a slow rate to facilitate the progressive absorption of the medicinal product.
Croatian: Reakcije na mjestu injiciranja mogu se umanjiti mijenjanjem mjesta injiciranja, odgađanjem injiciranja na istom mjestu i polaganim injiciranjem lijeka kako bi se poboljšala progresivna apsorpcija lijeka.
English: 1 pre-filled syringe contains 1 ml of water for injections.
Croatian: 1 napunjena štrcaljka sadrži 1 ml vode za injekcije.
English: Vigorous shaking with bubble formation should be avoided.
Croatian: Jako protresanje sa stvaranjem mjehurića treba izbjegavati.
English: Due to this mode of action, cetrorelix controls the secretion of gonadotropins (LH and FSH).
Croatian: Zbog ovakvog načina djelovanja, cetroreliks kontrolira lučenje gonadotropina (LH i FSH).
English: The following injections may be self-administered as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention.
Croatian: Iduće injekcije si pacijentica može davati samostalno ukoliko je upoznata sa znakovima i simptomima reakcija preosjetljivosti te svjesna mogućih posljedica i potrebe za hitnom liječničkom intervencijom.
English: INFORMATION IN BRAILLE cetrotide 0.25 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU cetrotide 0,25 mg
English: Repeated ovarian stimulation procedure
Croatian: Ponovljeni postupak stimulacije jajnika
English: Local reactions at the injection site (e.g. erythema, swelling and pruritus).
Croatian: Lokalne reakcije na mjestu injiciranja (npr. eritem, oticanje i pruritus).
English: In women undergoing ovarian stimulation the duration of action of cetrorelix is dose dependent.
Croatian: U žena kod kojih se provodi stimulacija jajnika, trajanje djelovanja cetroreliksa ovisno je o dozi.
English: Administration in the evening
Croatian: Primjena uvečer
English: • If you are injecting every morning: Start your injections on day 5 or 6 of the treatment cycle.
Croatian: • Ako injicirate svako jutro: Počnite s davanjem injekcija 5-og ili 6-og dana ciklusa liječenja.
English: The contents of 1 vial (0.25 mg cetrorelix) are to be administered once daily, at 24 h intervals, either in the morning or in the evening.
Croatian: Sadržaj jedne bočice (0,25 mg cetroreliksa) treba dati jednom dnevno, u intervalima od 24 sata, bilo ujutro ili navečer.
English: • Hypersensitivity to the active substance or any structural analogues of gonadotropin-releasing hormone (GnRH), extrinsic peptide hormones or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar ili neki od strukturalnih analoga hormona koji oslobađa gonadotropine (GnRH - od engl. gonadotropin-releasing hormone), ekstrinzične peptidne hormone ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: • If you are injecting every evening: Start your injections on day 5 of the treatment cycle.
Croatian: • Ako injicirate svaku večer: Počnite s davanjem injekcija 5-og dana ciklusa liječenja.