FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Granpidam have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Granpidam nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Lower doses of Granpidam may be needed in patients taking some medicines that affect the way Granpidam is broken down in the body.
Croatian: Niže doze lijeka mogu se propisati za liječenje bolesnika koji uzimaju pojedine lijekove koji utječu na način razgradnje lijeka Granpidam u tijelu.
English: It is not intended to provide practical advice on how to use Granpidam.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Granpidam.
English: In patients with PAH, sildenafil widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms.
Croatian: U bolesnika s PAHom sildenafil proširuje krvne žile u plućima čime se smanjuje krvni tlak i poboljšavaju simptomi.
English: In adults, Granpidam is taken at a dose of 20 mg three times a day.
Croatian: U odraslih osoba lijek Granpidam uzima se u dozi od 20 mg tri puta na dan.
English: Why is Granpidam approved?
Croatian: Zašto je lijek Granpidam odobren?
English: What are the benefits and risks of Granpidam?
Croatian: Koje su koristi i rizici od lijeka Granpidam?
English: For more information about treatment with Granpidam, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Granpidam pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Granpidam contains the active substance sildenafil.
Croatian: Lijek Granpidam sadrži djelatnu tvar sildenafil.
English: In children aged 1 to 17 years, the recommended dose is 20 mg three times a day in those over 20 kg. Higher doses should not be used.
Croatian: U djece u dobi od jedne do 17 godina preporučena je doza 20 mg tri puta na dan u djece s tjelesnom težinom većom od 20 kg.
English: In adults, it is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH.
Croatian: U odraslih osoba primjenjuje se u bolesnika s plućnom arterijskom hipertenzijom (PAH) stupnja II. (s blagim ograničenjem tjelesne aktivnosti) i III. (sa značajnim ograničenjem tjelesne aktivnosti).
English: The Committee recommended that Granpidam be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Granpidam u EU-u.
English: For practical information about using Granpidam, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Granpidam bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Therefore, the CHMP's view was that, as for Revatio, the benefit of Granpidam outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da koristi od lijeka Granpidam nadmašuju utvrđeni rizik, kao i za lijek Revatio.
English: How is Granpidam used?
Croatian: Kako se lijek Granpidam koristi?
English: How has Granpidam been studied?
Croatian: Kako je lijek Granpidam ispitivan?
English: • At the request of the European Medicines Agency:
Croatian: • na zahtjev Europske agencije za lijekove;
English: The relevance of these data for humans is unknown.
Croatian: Nije poznat značaj tih podataka za ljude.
English: Special care should be taken in women with signs and symptoms of active allergic conditions.
Croatian: Potreban je poseban oprez u žena sa znacima i simptomima aktivnog alergijskog stanja.
English: No teratogenic effects were observed.
Croatian: Nisu primijećeni teratogeni učinci.
English: Overdose in humans may result in a prolonged duration of action.
Croatian: Predoziranje u ljudi može dovesti do produljenog trajanja djelovanja.
English: 5340 BH Oss, The Netherlands.
Croatian: 5340 BH Oss, Nizozemska.
English: Your doctor will decide, depending on the severity, if additional monitoring is required during treatment.
Croatian: Vaš liječnik će odlučiti, ovisno o težini alergije, treba li Vas dodatno nadzirati tijekom liječenja.
English: Excretion occurs via faeces (approximately 75 %) and urine (approximately 22 %).
Croatian: Izlučivanje se odvija fecesom (oko 75%) i urinom (oko 22%).
English: Gonadotrophins play an important role in human fertility and reproduction.
Croatian: Gonadotropini imaju važnu ulogu u ljudskoj plodnosti i reprodukciji.
English: Do not mix Orgalutran with any other medicines.
Croatian: Nemojte miješati Orgalutran s drugim lijekovima.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenjaza stavljanje lijeka u promet:
English: If you have an active allergic condition, please tell your doctor.
Croatian: Ako imate neko aktivno alergijsko stanje, obavijestite svog liječnika.
English: The major circulating component in plasma is ganirelix.
Croatian: Glavna komponenta koja cirkulira u plazmi je ganireliks.
English: Ask your doctor for further information.
Croatian: Za dodatne informacije upitajte svog liječnika.
English: Do not use Orgalutran during pregnancy and breast-feeding.
Croatian: Nemojte koristiti Orgalutran za vrijeme trudnoće i dojenja.
English: Swab the injection site with a disinfectant (for example alcohol) to remove any surface bacteria.
Croatian: Obrišite mjesto injekcije sredstvom za dezinfekciju (na primjer alkoholom) kako biste uklonili površinske bakterije.
English: Pinch up a large area of skin between finger and thumb.
Croatian: Stisnite veću površinu kože između kažiprsta i palca.
English: The metabolite profile of Orgalutran in humans was similar to that found in animals.
Croatian: Profil metabolita lijeka Orgalutran u ljudi sličan je onome nađenom u životinja.
English: Women weighing less than 50 kg or more than 90 kg
Croatian: Žene tjelesne težine manje od 50 kg ili veće od 90 kg
English: Date of first authorisation: 17 May 2000 Date of last renewal: 10 May 2010
Croatian: Datum posljednje obnove odobrenja: 10. svibnja 2010.
English: However, based on the small number of patients treated so far, an effect cannot be excluded.
Croatian: Međutim, zbog malog broja dosad liječenih bolesnica ne može se isključiti određeni utjecaj tjelesne mase.
English: (See section4.8.
Croatian: (Vidjeti dio 4.8.)
English: Faeces only contain metabolites.
Croatian: U fecesu se nalaze samo metaboliti.
English: Orgalutran and FSH should be administered approximately at the same time.
Croatian: Orgalutran i FSH treba primijeniti približno u isto vrijeme.
English: Do not stop using Orgalutran unless advised to by your doctor, as this may affect the outcome of your treatment.
Croatian: Nemojte prestati primjenjivati Orgalutran, osim po preporuci liječnika, jer to može utjecati na ishod liječenja.
English: Use the pre-filled syringe only once.
Croatian: Napunjenu štrcaljku upotrijebite samo jedanput.
English: Remove needle cover.
Croatian: Skinite poklopac igle.
English: This syndrome is related to the stimulation procedure with gonadotrophins.
Croatian: Ovaj sindrom povezan je s postupkom stimulacije gonadotropinima.
English: The injection site should be varied to prevent lipoatrophy.
Croatian: Mjesto injiciranja treba mijenjati kako bi se spriječila lipoatrofija.
English: Preclinical data reveal no special hazard for humans based on safety pharmacology, repeated dose toxicity and genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza i genotoksičnosti.
English: Do not use this medicine after the expiry date which is stated on the carton and on the label after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake "EXP".
English: As a result a rapid, profound, reversible suppression of endogenous gonadotrophins occurs, without initial stimulation as induced by GnRH agonists.
Croatian: Kao rezultat toga nastupa brza, duboka, reverzibilna supresija endogenog gonadotropina, bez početne stimulacije kakvu potiče agonist GnRH-a.
English: If you are more than 6 hours late (so the time between two injections is longer than 30 hours) administer the dose as soon as possible and contact your doctor for further advice.
Croatian: Ako kasnite više od 6 sati (tako da je razdoblje između dviju injekcija dulje od 30 sati), primijenite dozu čim se sjetite, a zatim se javite liječniku radi daljnjih uputa.
English: For posology and method of administration, see section 4.2.
Croatian: Za doziranje i način primjene, vidjeti dio 4.2.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Orgalutran
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Orgalutran.
English: If this happens, do not inject Orgalutran, but remove the syringe, cover the injection site with a swab containing disinfectant and apply pressure; bleeding should stop in a minute or two.
Croatian: Ako se to dogodi, nemojte injicirati Orgalutran, nego izvadite štrcaljku i pritisnite mjesto uboda vatom s dezinfekcijskim sredstvom; krvarenje će prestati za 1-2 minute.
English: Orgalutran has shown to be safe and effective in women undergoing multiple treatment cycles.
Croatian: Orgalutran se pokazao sigurnim i učinkovitim u žena koje su završile više ciklusa liječenja.
English: The local reaction normally disappears within 4 hours of administration.
Croatian: Lokalna reakcija obično nestaje unutar 4 sata od primjene.
English: Start again with a new syringe.
Croatian: Postupak ponovite s novom štrcaljkom.
English: Insert the needle at the base of the pinched-up skin at an angle of 45° to the skin surface.
Croatian: Ubodite iglu na dnu stisnute kože pod kutom od 45° u odnosu na površinu kože.
English: ]-GnRH with a molecular weight of 1570.4.
Croatian: ]-GnRH, molekularne mase 1570,4.
English: Very rare: may affect up to 1 in 10,000 women Allergic reactions have been observed, as early as with the first dose.
Croatian: Vrlo rijetko: mogu se javiti u do 1 na 10 000 žena - alergijske reakcije zabilježene su već kod primjene prve doze
English: Follicles are small round sacs that contain the egg cells.
Croatian: Folikuli su male okrugle vrećice koje sadrže jajne stanice.
English: The amino acids at positions 1, 2, 3, 6, 8 and 10 of the natural GnRH decapeptide have been substituted resulting in N-Ac-D-Nal(2)
Croatian: Aminokiseline na pozicijama 1, 2, 3, 6, 8 i 10 prirodnog dekapeptida GnRH su zamijenjene, tako da je nastao [N-Ac-D-Nal(2) D-pClPhe
English: • Difficulty breathing (dyspnoea)
Croatian: • otežano disanje (dispneja)
English: Serum hormone levels returned to pre-treatment values within two days after the last injection.
Croatian: Razine hormona u serumu vratile su se na vrijednosti prije liječenja u roku od dva dana nakon posljednje injekcije.
English: If you realise that you forgot a dose, administer it as soon as possible.
Croatian: Ako shvatite da ste propustili dozu, primijenite je čim se sjetite.
English: If you use more Orgalutran than you should Contact your doctor.
Croatian: Ako primijenite više lijeka Orgalutran nego što ste trebali Javite se liječniku.
English: Based on your ovarian response, your doctor may decide to start on another day.
Croatian: Ovisno o odgovoru Vaših jajnika na stimulaciju, liječnik može odlučiti započeti primjenu i neki drugi dan.
English: The bioavailability of Orgalutran following subcutaneous administration is approximately 91 %.
Croatian: Bioraspoloživost lijeka Orgalutran nakon supkutane primjene iznosi približno 91%.
English: If you administer the injections yourself or have it done by your partner, follow the instructions below carefully.
Croatian: Ako si injekcije dajete sami, ili Vam je daje partner, pažljivo slijedite naputke u daljnjem tekstu.
English: Cases of allergic reactions have been reported, as early as with the first dose.
Croatian: Prijavljeni su slučajevi alergijskih reakcija već kod primjene prve doze.
English: In animals, exposure to ganirelix at the time of implantation resulted in litter resorption (see section 5.3).
Croatian: U životinja je izloženost ganireliksu u vrijeme implantacije dovela do resorpcije zametaka (vidjeti dio 5.3).
English: What Orgalutran is and what it is used for
Croatian: Što je Orgalutran i za što se koristi
English: The metabolites are small peptide fragments formed by enzymatic hydrolysis of ganirelix at restricted sites.
Croatian: Metaboliti su mali fragmenti peptida nastali enzimskom hidrolizom ganireliksa na ograničenim područjima.
English: Manufacturer N.V. Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, The Netherlands.
Croatian: Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, Nizozemska.
English: The possibility of interactions with commonly used medicinal products, including histamine liberating medicinal products, cannot be excluded.
Croatian: Ne može se isključiti mogućnost interakcije s uobičajeno primjenjivanim lijekovima, uključujući lijekove koji oslobađaju histamin.
English: Do not use if the solution contains particles or is not clear.
Croatian: Nemojte primijeniti lijek ako otopina sadrži čestice ili nije bistra.
English: However, the preparations should not be mixed and different injection sites are to be used.
Croatian: Međutim, pripravci se ne smiju miješati i treba ih injicirati na različitim mjestima.
English: The adverse reactions are classified according to MedDRA system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Croatian: Nuspojave su kategorizirane prema MedDRA klasifikaciji organskih sustava i učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100).
English: Do not use Orgalutran if you are allergic to ganirelix or any of the other ingredients of this medicine (listed in section6); if you are hypersensitive to gonadotrophin releasing hormone (GnRH) ora GnRH analogue; if you have a moderate or severe kidney or liver disease; if you are pregnant or breast-feeding.
Croatian: Nemojte primjenjivati Orgalutran ako ste alergični na ganireliks ili neki drugi sastojak ovog lijeka (naveden u dijelu6.); ako ste preosjetljivi na gonadotropin-oslobađajući hormon (GnRH) ili neki analog GnRH-a; ako imate umjerenu ili tešku bolest bubrega ili jetre; ako ste trudni ili dojite.
English: In women, FSH is needed for the growth and development of follicles in the ovaries.
Croatian: FSH je potreban u žena za rast i razvoj folikula u jajnicima.
English: Moderate or severe impairment of renal or hepatic function.
Croatian: - Umjereno ili teško oštećenje bubrežne ili jetrene funkcije.
English: The safety and efficacy of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg (see also section 5.1 and 5.2).
Croatian: Nisu ustanovljene sigurnost i djelotvornost lijeka Orgalutran u žena tjelesne težine manje od 50 kg ili veće od 90 kg (vidjeti i dijelove 5.1 i 5.2).
English: During Orgalutran treatment the average incidence of LH rises (> 10 IU/L) with concomitant progesterone rise (> 1 ng/mL) was 0.3 - 1.2 % compared to 0.8 % during GnRH agonist treatment.
Croatian: Tijekom liječenja lijekom Orgalutran prosječna incidencija porasta LH-a (> 10 IU/l) uz istodobni porast progesterona (> 1 ng/ml) iznosila je 0,3-1,2% u usporedbi s 0,8% prilikom liječenja agonistom GnRH-a.
English: Pharmacokinetic parameters after multiple subcutaneous dosing of Orgalutran (once daily injection) were similar to those after a single subcutaneous dose.
Croatian: Farmakokinetički parametri nakon višekratne supkutane primjene Orgalutran injekcija (jedanput na dan) bili su slični onima nakon jednokratne supkutane doze.
English: In the absence of clinical experience, Orgalutran treatment is not advised in women with severe allergic conditions.
Croatian: S obzirom da nema kliničkog iskustva, ne preporučuje se liječenje lijekom Orgalutran u žena s teškim alergijskim stanjima.
English: There are no adequate data from the use of ganirelix in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni ganireliksa u trudnica.
English: In case of overdose, Orgalutran treatment should be (temporarily) discontinued.
Croatian: U slučaju predoziranja treba (privremeno) prekinuti liječenje lijekom Orgalutran.
English: Timing of last injection
Croatian: Vrijeme primjene posljednje injekcije
English: FSH dose adjustments should be based on the number and size of growing follicles, rather than on the amount of circulating oestradiol (see section 5.1).
Croatian: Prilagodbe doze FSH-a trebaju se temeljiti na broju i veličini rastućih folikula prije nego na količini estradiola u cirkulaciji (vidjeti dio 5.1).
English: Latex allergy
Croatian: Alergija na lateks
English: Initiation of Orgalutran treatment on day 5 can prevent these premature LH rises without compromising the clinical outcome.
Croatian: Započinjanjem davanja lijeka Orgalutran 5. dana može se spriječiti te prijevremene poraste LH-a, a da se ne kompromitira klinički ishod.
English: Orgalutran should only be prescribed by a specialist experienced in the treatment of infertility.
Croatian: Orgalutran treba propisati samo liječnik specijalist s iskustvom u liječenju neplodnosti.
English: The other ingredients are acetic acid, mannitol, water for injections.
Croatian: Drugi sastojci su acetatna kiselina, manitol, voda za injekcije.
English: No data on acute toxicity of Orgalutran in humans are available.
Croatian: Nema dostupnih podataka o akutnoj toksičnosti lijeka Orgalutran u ljudi.
English: It is not known whether ganirelix is excreted in breast milk.
Croatian: Nije poznato izlučuje li se ganireliks u majčino mlijeko.
English: Orgalutran is available in packs of 1 or 5 pre-filled syringes.
Croatian: Orgalutran je dostupan u pakiranju od 1 ili 5 napunjenih štrcaljki.
English: Clean about 5 cm (two inches) around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.
Croatian: Očistite otprilike 5 cm oko predviđenog mjesta uboda i pustite da se sredstvo suši najmanje jednu minutu prije nego nastavite.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, anti-gonadotrophin-releasing hormones, ATC code: H01CC01.
Croatian: Farmakoterapijska skupina: hipofizni, hipotalamički hormoni i analozi; inhibitori oslobađanja gonadotropina, ATK oznaka: H01CC01.
English: Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
Croatian: Stoga je važno rano ultrazvučno potvrditi da se radi o materničnoj trudnoći.
English: Hypersensitivity to the active substance 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: Gently draw back the plunger to check if the needle is positioned correctly.
Croatian: Nježno povucite unazad klip štrcaljke kako biste provjerili je li igla ispravno postavljena.
English: The need for luteal phase support in cycles using Orgalutran has not been studied.
Croatian: Nije ispitivana potreba za podrškom lutealnoj fazi u ciklusima u kojima se koristio Orgalutran.
English: • Swelling of face, lips, tongue, and/or throat that may cause difficulty in breathing and/or swallowing (angioedema and/or anaphylaxis)
Croatian: • oticanje lica, usana, jezika i/ili grla koje može uzrokovati otežano disanje i/ili gutanje (angioedem i/ili anafilaksija)
English: In acute toxicity studies in rats and monkeys non-specific toxic symptoms such as hypotension and bradycardia were only observed after intravenous administration of ganirelix over 1 and 3 mg/kg, respectively.
Croatian: U ispitivanjima akutne toksičnosti na štakorima i majmunima, nespecifični simptomi toksičnosti poput hipotenzije i bradikardije opaženi su samo nakon intravenske primjene ganireliksa u dozama većim od 1 mg/kg odnosno 3 mg/kg.
English: Pharmacokinetic analysis indicates an inverse relationship between body weight and serum concentrations of Orgalutran.
Croatian: Farmakokinetička analiza ukazuje na inverzni odnos tjelesne težine i koncentracija lijeka Orgalutran u serumu.
English: What Orgalutran is and what it is used for What you need to know before you use Orgalutran How to use Orgalutran
Croatian: Što je Orgalutran i za što se koristi Što morate znati prije nego počnete primjenjivati Orgalutran Kako primjenjivati Orgalutran Moguće nuspojave
English: In patients undergoing controlled ovarian stimulation the median duration of Orgalutran treatment was 5 days.
Croatian: U bolesnica uključenih u postupak kontrolirane stimulacije jajnika, medijan trajanja liječenja lijekom Orgalutran bio je 5 dana.
English: Paediatric population There is no relevant use of Orgalutran in the paediatric population.
Croatian: Pedijatrijska populacija Nema relevantne primjene lijeka Orgalutran u pedijatrijskoj populaciji.
English: Very common: may affect more than 1 in 10 women Local skin reactions at the site of injection (predominantly redness, with or without swelling).
Croatian: Vrlo često: mogu se javiti u više od 1 na 10 žena - lokalna reakcija kože na mjestu injekcije (pretežno crvenilo sa ili bez otekline).
English: OHSS must be considered an intrinsic risk of gonadotrophin stimulation.
Croatian: OHSS se mora smatrati rizikom svojstvenim stimulaciji gonadotropinom.
English: Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.
Croatian: Štrcaljku izvucite brzo i pritisnite mjesto uboda vatom s dezinfekcijskim sredstvom.
English: The elimination half-life (t½) is approximately 13 hours and clearance is approximately 2.4 L/h.
Croatian: Poluvrijeme eliminacije (t½) iznosi oko 13 sati, a klirens je približno 2,4 l/h.
English: Orgalutran (0.25 mg) should be injected just under the skin once daily, starting on day 5 or day 6 of stimulation.
Croatian: Orgalutran (0,25 mg) treba primijeniti injekcijom pod kožu jedanput na dan, počevši od 5. ili 6. dana stimulacije.
English: Reported in one subject after the first Orgalutran dose.
Croatian: Prijavljeno u jedne ispitanice nakon prve doze lijeka Orgalutran.
English: What Orgalutran contains
Croatian: Što Orgalutran sadrži
English: The time between two Orgalutran injections as well as the time between the last Orgalutran injection and hCG injection should not exceed 30 hours, as otherwise a premature ovulation (i.e. release of egg cells) may occur.
Croatian: Razdoblje između dvije injekcije lijeka Orgalutran kao i razdoblje između posljednje injekcije lijeka Orgalutran i injekcije hCG-a ne smije premašiti 30 sati jer u protivnom može doći do prijevremene ovulacije (tj. oslobađanja jajnih stanica).
English: In clinical studies, one hour after injection, the incidence of at least once a moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12 % in Orgalutran treated patients and 25 % in patients treated subcutaneously with a GnRH agonist.
Croatian: U kliničkim ispitivanjima, prema prijavama bolesnica, incidencija barem jedne umjerene ili teške lokalne reakcije na koži po ciklusu, sat vremena nakon injekcije, iznosila je 12% za bolesnice liječene lijekom Orgalutran i 25% za bolesnice liječene supkutanim injekcijama agonista GnRH-a.
English: Daily treatment with Orgalutran should be continued up to the day that sufficient follicles of adequate size are present.
Croatian: Svakodnevne injekcije lijeka Orgalutran treba primjenjivati sve dok se ne utvrdi postojanje dovoljnog broja folikula odgovarajuće veličine.
English: Acetic acid;
Croatian: Acetatna kiselina
English: OHSS should be treated symptomatically, e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.
Croatian: OHSS se mora liječiti simptomatski, tj. mirovanjem, intravenskim infuzijama otopina elektrolita ili koloida i heparinom.