FrancophonIA/ELRC3.0 huggingface dataset:
English: Warnings and precautions Talk to your doctor before taking Karvezide and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems or have a kidney transplant
Croatian: Obratite se svome liječniku prije nego uzmete Karvezide i ako se bilo što od sljedećeg odnosi na Vas:
English: Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 150 mg irbesartana i 12,5 mg hidroklorotiazida.
English: You will also need:
Croatian: Također će Vam biti potrebne:
English: If this happens, your doctor will need to examine you as soon as possible.
Croatian: Ako se to dogodi, Vaš će Vas liječnik morati što prije pregledati.
English: In your body:
Croatian: U Vašem tijelu:
English: • Treatment is continued until you get the desired response.
Croatian: • Liječenje se nastavlja sve dok se ne postigne željeni odgovor.
English: They will supervise your first injection.
Croatian: Oni će nadzirati Vašu prvu injekciju.
English: • This may take up to 5 weeks.
Croatian: • To može trajati do 5 tjedana.
English: • Give yourself the injection at the same time each day.
Croatian: • Injekciju primjenjujte svaki dan u isto vrijeme.
English: ATC code: G03GA30.
Croatian: ATK oznaka: G03GA30.
English: Multiple pregnancy may lead to medical complications for you and your babies.
Croatian: Višeplodne trudnoće mogu uzrokovati medicinske komplikacije za Vas i Vaše bebe.
English: It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
Croatian: Prihvatljivo je trajanje stimulacije u bilo kojem od ciklusa produljiti do 5 tjedana.
English: Please contact your doctor.
Croatian: Obratite se svojem liječniku.
English: This helps the women to become pregnant.
Croatian: To ženama pomaže da ostanu trudne.
English: The first injection should be performed under direct medical supervision.
Croatian: Prvu injekciju treba dati pod neposrednim medicinskim nadzorom.
English: Treatment is directed to symptoms.
Croatian: Liječenje ovisi o simptomima.
English: Date of latest renewal: 8 May 2017
Croatian: Datum posljednje obnove odobrenja: 8. svibnja 2017.
English: Follow the instructions exactly, as it may differ from your past experience.
Croatian: Strogo se pridržavajte uputa, jer se mogu razlikovati od Vašeg prethodnog iskustva.
English: Tres Cantos E-28760 Madrid Spain
Croatian: Tres Cantos E-28760 Madrid Španjolska
English: Children and adolescents Pergoveris is not for use in children and adolescents below 18 years old.
Croatian: Djeca i adolescenti Pergoveris nije namijenjen primjeni u djece i adolescenata mlađih od 18 godina.
English: OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event.
Croatian: OHSS može brzo napredovati (unutar 24 sata) ili čak nekoliko dana te prerasti u ozbiljan neželjeni događaj.
English: Not provided in the pack:
Croatian: Nije sadržano u pakiranju:
English: These women are usually infertile.
Croatian: Obično su te žene neplodne.
English: Pergoveris must not be used when an effective response cannot be obtained, such as:
Croatian: Pergoveris se ne smije koristiti kada se ne može postići učinkovita reakcija, primjerice, u slučaju:
English: • Put it aside for later use.
Croatian: • Odložite ga na stranu za kasniju uporabu.
English: Zone Industrielle de l'Ouriettaz CH-1170 Aubonne Switzerland
Croatian: Zone Industrielle de l'Ouriettaz CH-1170 Aubonne Švicarska
English: It most often occurs after hormonal treatment has been discontinued and reaches its maximum at about seven to ten days following treatment.
Croatian: Najčešće se događa nakon prekida hormonskog liječenja i doseže svoj maksimum otprilike sedam do deset dana nakon liječenja.
English: The mean residence time is approximately 5 hours.
Croatian: Prosječno vrijeme zadržavanja iznosi otprilike 5 sati.
English: The patient should be hospitalised and specific therapy for OHSS started.
Croatian: Pacijenticu je potrebno hospitalizirati i započeti specifičnu terapiju za OHSS.
English: Amount to Be Set for a Second Injection if "0", injection complete ifnot"0",needsecond injection Injectthis amount..........usingnewpen if"0", injectioncomplete if not "0", need second injection Inject this amount ..........using new pen if "0", injection complete ifnot"0",needsecond injection Injectthis amount..........usingnewpen if"0", injectioncomplete if not "0", need second injection Inject this amount ..........using new pen if "0", injection complete ifnot"0",needsecond injection Injectthis amount..........usingnewpen if"0", injectioncomplete if not "0", need second injection Inject this amount ..........using new pen if "0", injection complete ifnot"0",needsecond injection Injectthis amount..........usingnewpen if"0", injectioncomplete if not "0", need second injection Inject this amount ..........using new pen if"0", injectioncomplete ifnot"0",needsecond injection Injectthisamount..........usingnewpen if"0", injectioncomplete ifnot"0",needsecond injection Injectthisamount..........usingnewpen if"0", injectioncomplete ifnot"0",needsecond injection Injectthisamount..........usingnewpen if"0", injectioncomplete ifnot"0",needsecond injection Injectthisamount..........usingnewpen
Croatian: Količina koju treba namjestiti kod druge injekcije ako je "0", Injekcija je potpuna ako nije "0", potrebna je druga injekcija Ubrizgajte ovu količinu ..........iz nove brizgalice ako je "0", Injekcija je potpuna ako nije "0", potrebna je druga injekcija Ubrizgajte ovu količinu ..........iz nove brizgalice ako je "0", Injekcija je potpuna ako nije "0", potrebna je druga injekcija Ubrizgajte ovu količinu ..........iz nove brizgalice ako je "0", Injekcija je potpuna ako nije "0", potrebna je druga injekcija Ubrizgajte ovu količinu ..........iz nove brizgalice ako je "0", Injekcija je potpuna ako nije "0", potrebna je druga injekcija Ubrizgajte ovu količinu ..........iz nove brizgalice ako je "0", Injekcija je potpuna ako nije "0", potrebna je druga injekcija Ubrizgajte ovu količinu ..........iz nove brizgalice ako je "0", Injekcija je potpuna ako nije "0", potrebna je druga injekcija Ubrizgajte ovu količinu ..........iz nove brizgalice ako je "0", Injekcija je potpuna ako nije "0", potrebna je druga injekcija Ubrizgajte ovu količinu ..........iz nove brizgalice ako je "0", Injekcija je potpuna ako nije "0", potrebna je druga injekcija Ubrizgajte ovu količinu ..........iz nove brizgalice ako je "0", Injekcija je potpuna ako nije "0", potrebna je druga injekcija Ubrizgajte ovu količinu ..........iz nove brizgalice ako je "0", Injekcija je potpuna ako nije "0", potrebna je druga injekcija Ubrizgajte ovu količinu ..........iz nove brizgalice ako je "0", Injekcija je potpuna ako nije "0", potrebna je druga injekcija Ubrizgajte ovu količinu ..........iz nove brizgalice
English: The doctor might ask you to stop using Pergoveris.
Croatian: Liječnik će možda od Vas zatražiti da prestanete primjenjivati Pergoveris.
English: Complete a partial injection (only when needed).
Croatian: 8.2. Dovršite djelomičnu injekciju (samo kad je to potrebno).
English: In these patients, Pergoveris may increase the risk of an acute attack.
Croatian: U tih pacijentica Pergoveris može povećati rizik od akutnog napadaja.
English: Get together everything you need and lay them out
Croatian: Pripremite sve što Vam je potrebno i položite na površinu
English: • If no droplet is seen, follow the instructions on the following page.
Croatian: • Ako ne ugledate kapljicu, slijedite upute na sljedećoj stranici.
English: • Inject under the skin, as you were taught.
Croatian: • Injicirajte pod kožu, kao što Vam je objašnjeno.
English: • malformations of sexual organs incompatible with pregnancy
Croatian: • malformacije spolnih organa, nespojive s trudnoćom
English: Very rare (may affect up to 1 in 10,000 people): • Your asthma may get worse.
Croatian: Vrlo rijetko (mogu se pojaviti kod do 1 na 10 000 osoba): • može doći do pogoršanja astme.
English: EXP Shelf life after first use: 28 days
Croatian: EXP Rok valjanosti nakon prvog otvaranja: 28 dana
English: How to prepare and use the Pergoveris powder and solvent Before starting the preparation, please read these instructions the whole way through first: Give yourself the injection at the same time each day.
Croatian: Kako pripremiti i primijeniti Pergoveris prašak i otapalo Prije početka pripreme molimo prvo pročitajte ove upute u cijelosti: Injekciju si dajte svakog dana u isto vrijeme.
English: Verify you select the prescribed pen.
Croatian: Provjerite jeste li odabrali propisanu brizgalicu.
English: The best time to have sex is on the day of the hCG injection and the day after.
Croatian: Najbolje vrijeme za spolni odnos je isti dan kada se primi injekcija hCG i dan nakon toga.
English: Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
Croatian: Terapiju treba ponovo započeti u idućem ciklusu s dozom FSH nižom u odnosu na prvi ciklus.
English: This instructions for use was last revised in:
Croatian: Ove su upute za primjenu zadnji puta revidirane u:
English: Do not share the pen and/or needles with another person, because doing so can cause an infection.
Croatian: Nemojte dijeliti brizgalicu i/ili igle s drugom osobom, jer to može prouzročiti infekciju.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti.
English: If you do not see a tiny drop(s) of fluid at or near the tip the first time you use a new pen:
Croatian: Ako ne ugledate malu(e) kapljicu(e) tekućine na vršku ili blizu vrška kada prvi put koristite novu brizgalicu:
English: Push the plunger until the air bubbles are gone.
Croatian: Gurajte klip sve dok ne nestanu svi mjehurići zraka.
English: • your skin becomes fragile and easily blistered, especially skin that has been frequently exposed to sunlight
Croatian: • koža Vam postaje krhka i lako se stvaraju mjehurići, naročito na mjestima koja su često izložena sunčevoj svjetlosti
English: Warning: Always make sure to use a new needle for each injection.
Croatian: Upozorenje: Pazite na to da za svaku injekciju uvijek koristite novu iglu.
English: Dispose of all used items.
Croatian: Bacite sve korištene predmete.
English: Both belong to the family of hormones called “gonadotropins”, which are involved in reproduction and fertility.
Croatian: Obje pripadaju u skupinu hormona nazvanu „gonadotropini“ koji sudjeluju u reprodukciji i plodnosti.
English: • FSH stimulates the production of eggs
Croatian: • FSH stimulira stvaranje jajnih stanica
English: • After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
Croatian: • Kada se prašak otopi (to se obično događa odmah) provjerite je li dobivena otopina bistra te da ne sadrži nikakve čestice.
English: Never share needles.
Croatian: Nikad nemojte dijeliti igle s drugima.
English: • It comes as a powder and liquid, which you need to mix together and then use straight away.
Croatian: • Lijek dolazi u obliku praška i tekućine koje trebate skupa pomiješati i potom odmah primijeniti.
English: Deterioration or a first appearance of this condition may require cessation of treatment.
Croatian: Pogoršanje ili pojava prvih simptoma te bolesti mogu zahtijevati prekid terapije.
English: Take as much time as you need to inject all the solution.
Croatian: Dajte si vremena koliko god Vam je potrebno da injicirate svu otopinu.
English: Use the treatment diary to record the amount injected.
Croatian: Koristite dnevnik liječenja kako biste zabilježili ubrizganu količinu.
English: This is to help you get pregnant.
Croatian: To će Vam pomoći da ostanete trudni.
English: • 1 needle for preparation
Croatian: • 1 igla za pripremu
English: This medicine is used to stimulate the development of follicles (each containing an egg) in your ovaries.
Croatian: Ovaj se lijek koristi za stimulaciju razvoja folikula (od kojih svaki sadrži jajnu stanicu) u Vašim jajnicima.
English: Pergoveris is contraindicated in patients with:
Croatian: Pergoveris je kontraindiciran za pacijentice koje imaju:
English: Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Croatian: Budući da su ove pacijentice amenoreične te imaju i nisko lučenje endogenog estrogena, terapija može započeti u bilo koje vrijeme.
English: Warning: If the Dose Feedback Window shows a number higher than 0, the Pergoveris pre-filled pen is empty and you have not received your full prescribed dose.
Croatian: Upozorenje: Ako prozorčić za prikaz doze prikazuje broj veći od 0, Pergoveris napunjena brizgalica je prazna i niste primili punu propisanu dozu.
English: The pH of the reconstituted solution is 6.5-7.5.
Croatian: Rekonstitucija pH rekonstituirane otopine iznosi 6,5-7,5.
English: Safety and effectiveness of this medicinal product in elderly patients have not been established.
Croatian: Sigurnost i učinkovitost ovog lijeka u pacijenata starije dobi nije ustanovljena.
English: • Your doctor or nurse will show you how to prepare and inject this medicine.
Croatian: • Vaš liječnik ili medicinska sestra pokazat će Vam kako pripremiti i ubrizgati lijek.
English: Pergoveris is for an immediate and single use following first opening and reconstitution.
Croatian: Pergoveris je namijenjen neposrednoj i jednokratnoj primjeni nakon prvog otvaranja i rekonstitucije.
English: They might ask you to stop using this medicine (see in section 4. under “Most serious side effects”).
Croatian: Možda će Vas savjetovati da prestanete primjenjivati ovaj lijek (pogledajte u dijelu 4 pod „Najozbiljnije nuspojave“).
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancies.
Croatian: Smatra se da je to posljedica razlika u karakteristikama roditelja (npr.: dob majke, karakteristike sperme) i višeplodnih trudnoća.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Pergoveris.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Pergoveris.
English: • Store the pen in its original packaging in a safe place and as indicated in the package leaflet.
Croatian: • Čuvajte brizgalicu u njezinom originalnom pakiranju na sigurnom mjestu i kako je navedeno u uputi o lijeku.
English: Any unused solution must be discarded.
Croatian: Sva neiskorištena otopina mora se baciti.
English: The frequency categories used are: 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), not known (cannot be estimated from the available data).
Croatian: Primjenjene kategorije učestalosti su sljedeće: vrlo često (≥1/10), često (1/100 i <1/10), manje često (1/1000 i <1/100), rijetko (1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: In this case, your doctor will give you a lower follitropin alfa dose in the following cycle.
Croatian: U tom će Vam slučaju liječnik propisati manje doze folitropina alfa u sljedećem ciklusu.
English: Paediatric population There is no relevant use of this medicinal product in the paediatric population.
Croatian: Pedijatrijska populacija Nema relevantne primjene ovog lijeka u pedijatrijskoj populaciji.
English: • Complications of OHSS such as twisting of ovaries or blood clotting occur rarely (may affect up to 1 in 1,000 people).
Croatian: • Komplikacije OHSS-a, poput torzije jajnika (bolno uvrtanje jajnika) ili krvnih ugrušaka rijetke su (mogu se pojaviti kod do 1 na 1000 osoba).
English: Your doctor will tell you how many IUs of follitropin alfa to inject each day.
Croatian: Liječnik će Vam reći koliko IU folitropina alfa trebate ubrizgati svaki dan.
English: • if you are allergic to follicle stimulating hormone (FSH), luteinising hormone (LH) or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na folikul stimulirajući hormon (FSH), luteinizirajući hormon (LH) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Choose an injection site in the area your doctor or nurse has told you to use for the injection.
Croatian: 7.1. Odaberite mjesto za injekciju u području za koje su Vam liječnik ili medicinska sestra rekli da ga koristite za injekciju.
English: • After a minimum of 5 seconds, pull the needle out of the skin while keeping the dose setting knob pressed down (Fig. 11).
Croatian: • Nakon najmanje 5 sekundi, izvucite iglu iz kože dok držite kotačić za namještanje doze pritisnutim (Sl. 11).
English: When you do this, please carefully read and follow the instructions hereafter called “How to prepare and use the Pergoveris powder and solvent”.
Croatian: Kada budete to radili, pažljivo pročitajte upute u daljnjem tekstu pod naslovom „Kako pripremiti i upotrijebiti Pergoveris prašak i otapalo“.
English: • Remove any air bubbles: If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top.
Croatian: • Istisnite sve mjehuriće zraka: Ako primijetite zračne mjehuriće u štrcaljki, držite štrcaljku s iglom uperenom prema gore i lagano kuckajte štrcaljku dok se sav zrak ne skupi na vrhu.
English: • If they are satisfied that you can administer Pergoveris safely, you can then prepare and inject the medicine yourself at home.
Croatian: • Ako oni smatraju da si samostalno možete davati Pergoveris, možete pripremiti i injicirati lijek sami kod kuće.
English: In this case, the follitropin alfa dose is usually increased every 7 or every 14 days by 37.5 to 75 IU.
Croatian: U tom se slučaju doziranje folitropina alfa obično povećava svakih 7 ili 14 dana za 37,5 do 75 IU.
English: This side effect is very rare.
Croatian: Ova nuspojava je vrlo rijetka.
English: In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of Pergoveris.
Croatian: U slučaju primjene za vrijeme trudnoće, ne postoji dovoljno kliničkih podataka kojima bi se isključio teratogeni učinak lijeka Pergoveris.
English: There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and more protracted if pregnancy occurs.
Croatian: Postoje dokazi koji upućuju da hCG ima važnu ulogu u pokretanju OHSS-a te da sindrom može biti težeg oblika i dugotrajniji ako dođe do trudnoće.
English: Usually, OHSS resolves spontaneously with the onset of menses.
Croatian: OHSS obično spontano prestaje s nastupanjem menstruacije.
English: IF
Croatian: AKO
English: In rare cases this can also happen independently of OHSS (see in section 2. under “Blood clotting problems (thromboembolic events)”).
Croatian: U rijetkim se slučajevima to može dogoditi neovisno o OHSS-u (pogledajte dio 2 „Problemi sa zgrušavanjem krvi (tromboembolijski događaji)“).
English: If you are developing OHSS your doctor may not give you any hCG in this treatment cycle and you may be told not to have sex or that you should use a barrier contraceptive method for at least four days.
Croatian: Ako počnete razvijati OHSS, liječnik Vam možda neće dati hCG u tom ciklusu liječenja te će Vas uputiti da se suzdržavate od spolnih odnosa ili koristite barijernu kontracepciju najmanje četiri dana.
English: * The numbers on the Dose Feedback Window and reservoir holder represent the number of International Units (IU) of medication.
Croatian: * Brojevi u Prozorčiću za prikaz doze i na držaču spremnika predstavljaju broj međunarodnih jedinica (IU) lijeka.
English: Monitoring of stimulation cycles by ultrasound scans as well as oestradiol measurements are recommended to early identify risk factors.
Croatian: Praćenje ciklusa stimulacije ultrazvučnim pregledima i mjerenjima estradiola preporučuje se za rano prepoznavanje faktora rizika.
English: Powder: white to off-white lyophilised pellet.
Croatian: Prašak: bijele do bjelkaste liofilizirane pelete.
English: Fig. 4 Caution: If the peel-off seal is damaged or loose, do not use the needle.
Croatian: 4 Oprez: Ako je odvojiva zaštitna folija oštećena ili odvojena, nemojte uporabiti tu iglu.
English: Tumours of sex organs
Croatian: Tumori spolnih organa
English: • hypersensitivity to the active substances or to any of the excipients listed in section 6.1
Croatian: • preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: Pharmacokinetic/pharmacodynamic relationships There is no pharmacokinetic interaction with follitropin alfa when administered simultaneously.
Croatian: Farmakokinetički/farmakodinamički odnosi Nema farmakokinetske interakcije s folitropinom alfa kada se daju istodobno.
English: The majority of multiple conceptions are twins.
Croatian: Većina višeplodnih trudnoća je blizanačka.
English: In these women, the benefits of gonadotrophin administration need to be weighed against the risks.
Croatian: U tih žena treba usporediti koristi davanja gonadotropina s rizicima.
English: Store in refrigerator (2°C- 8°C).
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: Therefore, if signs of OHSS occur such as serum oestradiol level > 5,500 pg/mL or > 20,200 pmol/L and/or ≥ 40 follicles in total, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Croatian: Stoga, ako se pojave simptomi OHSS-a kao što su razina estradiola u serumu > 5500 pg/ml ili > 20 200 pmol/l i/ili ≥ 40 folikula ukupno, preporučuje se prestanak davanja hCG-a, a pacijentica se treba suzdržavati od spolnog odnosa ili upotrebljavati barijerne metode kontracepcije najmanje 4 dana.
English: Remove the needle immediately after each injection.
Croatian: Igle bacite odmah nakon svake injekcije.
English: Caution: Do not attach the needle too tightly; the needle could be difficult to remove after the injection.
Croatian: Oprez: Nemojte prečvrsto spojiti iglu; uklanjanje igle nakon injekcije moglo bi biti otežano.
English: Amount to Be Set for a Second Injection
Croatian: Količina koju treba namjestiti kod druge injekcije
English: This could cause chest pain, breathlessness, stroke or heart attack.
Croatian: To može uzrokovati bol u prsištu, nedostatak daha, moždani ili srčani udar.
English: Setting the dose prescribed by your doctor 6.1.
Croatian: Namještanje doze koju Vam je propisao liječnik 6.1.
English: • Record the treatment day number (column 1), date (column 2), time of your injection (column
Croatian: • Zabilježite redni broj dana liječenja (stupac 1), datum (stupac 2), vrijeme davanja injekcije
English: Pergoveris treatment seldom causes severe OHSS.
Croatian: Terapija lijekom Pergoveris rijetko uzrokuje teški OHSS.
English: What Pergoveris looks like and contents of the pack
Croatian: Kako Pergoveris izgleda i sadržaj pakiranja
English: It is for use in adult women (18 years old or above) who have low levels (severe deficiency) of “follicle stimulating hormone” (FSH) and “luteinising hormone” (LH).
Croatian: Namijenjen je primjeni u odraslih žena (18 godina ili starijima) s niskim razinama (težak nedostatak) „folikul stimulirajućeg hormona“ (FSH) i „luteinizirajućeg hormona“ (LH).
English: Prepare your needle.
Croatian: Pripremite iglu.
English: Prescribed Dose
Croatian: Propisana doza
English: The steady state volume of distribution is 10 L.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže je 10 l.
English: Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure.
Croatian: Često je prijavljen blagi ili umjereni OHSS te se treba smatrati intrinzičnim rizikom postupka stimulacije.