FrancophonIA/ELRC3.0 huggingface dataset:
English: The REKOVELLE pre-filled pen is a disposable, dial-a-dose pen that can be used to give more than 1 dose of REKOVELLE.
Croatian: REKOVELLE napunjena brizgalica je jednokratna brizgalica s mogućnošću odabira doze koja se može koristiti za primjenu više od 1 doze lijeka REKOVELLE.
English: • No. Priming must be performed only before giving the first injection with a new pen.
Croatian: Pripremu morate provesti samo prije prvog injiciranja s novom brizgalicom.
English: (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100).
Croatian: (≥1/100 do <1/10) i manje često (≥1/1000 do <1/100).
English: • Sleepiness/drowsiness
Croatian: • Pospanost/omamljenost
English: The apparent clearance for follitropin delta is low, i.e. 0.6 L/h after multiple subcutaneous administration, leading to high exposure.
Croatian: Prividni klirens folitropina delta je nizak, odnosno, 0,6 L/h nakon višekratne supkutane primjene što vodi ka visokoj izloženosti.
English: The trial compared the individualised dosing regimen of REKOVELLE where the daily dose is established for each patient and fixed throughout stimulation with no adjustments (see section 4.2) to follitropin alfa filled-by-mass at a starting dose of 11 micrograms (150 IU) for the first five days followed by dose adjustments from day 6 of stimulation based on follicular development in a GnRH antagonist protocol.
Croatian: Ispitivanjem se uspoređivao individualizirani režim doziranja lijeka REKOVELLE gdje je dnevna doza određena za svaku bolesnicu i bila je stalna tijekom stimulacije bez prilagođavanja (vidjeti dio 4.2) s folitropinom alfa određenim prema masenim jedinicama s početnom dozom od 11 mikrograma (150 IU) tijekom prvih pet dana, nakon čega se od 6. dana stimulacije, doza prilagođavala ovisno o razvoju folikula u protokolu liječenja s GnRH antagonistom.
English: This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen.
Croatian: Ovaj se lijek primjenjuje injekcijom pod kožu (potkožno) obično u donji dio trbuha.
English: Store in refrigerator (2 °C - 8 °C).
Croatian: Čuvajte u hladnjaku (2 °C - 8 °C).
English: In the overall trial population, the mean number of oocytes retrieved was 10.0 ± 5.6 with REKOVELLE (N=636) in the individualised dosing regimen and 10.4 ± 6.5 with follitropin alfa (N=643) at a starting dose of 150 IU followed by dose adjustments.
Croatian: U ukupnoj populaciji sudionika kliničkog ispitivanja, srednji broj dobivenih oocita bio je 10,0 ± 5,6 kod primjene lijeka REKOVELLE (N=636) s individualiziranim režimom doziranja i 10,4 ± 6,5 kod primjene folitropina alfa (N=643) s početnom dozom od 150 IU nakon čega su slijedile prilagodbe doze.
English: Bio-Technology General (Israel) Ltd. Be'er Tuvia Industrial Zone POB 571
Croatian: Be'er Tuvia Industrial Zone POB 571
English: Hormones used in the treatment of infertility such as this medicine may cause a high level of activity in the ovaries (ovarian hyperstimulation syndrome).
Croatian: Hormoni koji se koriste za liječenje neplodnosti, kao što je ovaj lijek, mogu uzrokovati visoku razinu aktivnosti jajnika (sindrom hiperstimulacije jajnika).
English: • Use the pen only for the medical condition it is prescribed for and as directed by your healthcare provider.
Croatian: • Brizalica se primijenjuje isključivo za medicinsko stanje za koje je propisana i prema uputama
English: You will need to give part of your prescribed dose using your current pen and the remainder of the dose using a new pen (split-dose injection) or you may throw away (dispose of) the pen you are using and use a new pen to give your full prescribed dose in 1 injection.
Croatian: Morat ćete primijeniti dio Vaše propisane doze uz korištenje brizgalice koju imate i preostalu dozu uz korištenje nove brizgalice (injiciranje podijeljene doze) ili možete baciti (odložiti) brizgalicu koju imate i koristiti novu brizgalicu za primjenu Vaše pune propisane doze u jednom injiciranju.
English: Before first use, store in the original package in order to protect from light.
Croatian: Prije prve primjene, čuvajte u originalnom pakiranju radi zaštite od svjetlosti.
English: Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Croatian: Prije početka liječenja, treba odgovarajuće ocijeniti neplodnost para, kao i procijeniti moguće kontraindikacije za trudnoću.
English: Instructions For Use
Croatian: 15. UPUTE ZA UPORABU
English: Put your used needles in a puncture-resistant container, such as a sharps disposal container right away after use.
Croatian: Odmah nakon upotrebe odložite Vaše iskorištene igle u neprobojni spremnik za odlaganje, kao što je spremnik za odlaganje oštrih predmeta.
English: • If no droplet appears after 5 tries, remove the needle (See Step 13), attach a new needle
Croatian: • Ukoliko se kapljica ne pojavi ni nakon 5 pokušaja, uklonite iglu (vidjeti Korak 13), postavite novu iglu (vidjeti Korake 3 do 6) i ponovite pripremu (vidjeti Korake 7 do 9).
English: Dose display window for example of prescribed dose
Croatian: Prozorčić za prikaz doze s primjerom propisane doze
English: Patients undergoing stimulation of follicular growth may experience ovarian enlargement and may be at risk of developing OHSS.
Croatian: Kod bolesnica koje su podvrgnute stimulaciji rasta folikula može doći do povećanja jajnika i postoji rizik od razvoja OHSS-a.
English: • Do not store the pen with the needle attached.
Croatian: • Nemojte čuvati brizgalicu sa spojenom iglom.
English: No interaction studies have been performed with REKOVELLE.
Croatian: Nisu provedena ispitivanja interakcija s lijekom REKOVELLE.
English: A single injection of 250 micrograms recombinant human chorionic gonadotropin (hCG) or 5,000 IU hCG is administered to induce final follicular maturation.
Croatian: Pojedinačna injekcija od 250 mikrograma rekombinantnog humanog korionskog gonadotropina (hCG) ili 5,000 IU hCG primjenjuje se u svrhu indukcije završnog sazrijevanja folikula.
English: What if the dose knob cannot be turned to the required dose?
Croatian: Što ako ne mogu okrenuti izbornik za podešavanje doze do potrebne doze?
English: Anti-FSH antibodies were measured pre-dosing and post-dosing in patients undergoing up to three repeated treatment cycles with REKOVELLE (665 patients in cycle 1 in the ESTHER-1 trial as well as 252 patients in cycle 2 and 95 patients in cycle 3 in the ESTHER-2 trial).
Croatian: Anti-FSH antitijela bila su mjerena prije doziranja i poslije doziranja u bolesnica koje su bile podvrgnute do tri ponovljena ciklusa liječenja lijekom REKOVELLE (665 bolesnica u 1. ciklusu kliničkog ispitivanja ESTHER-1, kao i 252 bolesnice u 2. ciklusu i 95 bolesnica u 3. ciklusu kliničkog ispitivanja ESTHER-2).
English: • Check that a droplet of liquid appears at the tip of the needle.
Croatian: • Provjerite je li se pojavila kapljica tekućine na vršku igle.
English: Paediatric population There is no relevant use of REKOVELLE in the paediatric population.
Croatian: Nema relevantne primjene lijeka REKOVELLE u pedijatrijskoj populaciji.
English: Ovarian hyperstimulation syndrome
Croatian: Sindrom hiperstimulacije jajnika
English: Vaginal haemorrhage Breast pain Breast tenderness
Croatian: Vaginalno krvarenje Bol u grudima Osjetljivost grudi
English: Split-dosing:
Croatian: Dijeljenje doze:
English: • Call your healthcare provider or local representative of the marketing authorisation holder (please refer to pa-tient information leaflet for contact details) before giving your REKOVELLE injection if you have questions.
Croatian: • Nazovite Vašeg zdravstvenog djelatnika ili lokalnog predstavnika nositelja odobrenja za stavljanje lijeka u promet (molimo potražite podatke za kontakt u uputi o lijeku) ukoliko imate bilo kakvih pitanja prije primjene injekcije lijeka REKOVELLE.
English: • If you will use a new pen to give your full prescribed dose instead of giving a split-dose injection, throw away (dispose of) your pen when there is not enough medicine in the pen for a full dose.
Croatian: • Ukoliko ćete koristiti novu brizgalicu za primjenu pune propisane doze umjesto da primijenite podijeljenu dozu, bacite (zbrinite) brizgalicu koja ne sadrži dovoljno lijeka za punu dozu.
English: REKOVELLE contains a potent gonadotropic substance capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Croatian: REKOVELLE sadrži potentnu gonadotropnu tvar koja može uzrokovati blage do teške nuspojave pa ga smije primjenjivati samo liječnik detaljno upoznat s problemima neplodnosti i njihovim liječenjem.
English: Read this booklet completely before using your REKOVELLE pre-filled pen and each time you get a new pen.
Croatian: U potpunosti pročitajte ove upute prije nego koristite REKOVELLE napunjenu brizgalicu, kao i svaki put kad dobijete novu brizgalicu jer u njima može biti novih podataka.
English: If you are not able to dial the full prescribed dose in your pen, this means that there is not enough medicine left in the pen to give the full dose.
Croatian: Ukoliko niste u mogućnosti odabrati punu propisanu dozu na Vašoj brizgalici, to znači da nije ostalo dovoljno lijeka za punu dozu u brizgalici.
English: After first use: 28 days when stored at or below 25 °C.
Croatian: Nakon prve primjene: 28 dana kada se čuva na temperaturi od ili ispod 25 °C.
English: • Tap with your finger on the cartridge holder to make any air bubbles in the cartridge rise to the top of the cartridge.
Croatian: • Kucnite prstom po držaču uloška kako bi se mjehurići zraka podigli prema vrhu uloška.
English: Following subcutaneous administration, the apparent clearance of follitropin delta is 0.6 L/h and the clearance after intravenous is 0.3 L/h.
Croatian: Nakon supkutane primjene, prividni klirens folitropina delta je 0,6 L/h,a klirens nakon intravenske primjene je 0,3 L/h.
English: The following symptoms may be observed in severe cases of OHSS: abdominal pain, discomfort and distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Croatian: Sljedeći se simptomi mogu primijetiti u teškim slučajevima OHSS-a: bol, nelagoda i distenzija abdomena, izrazito povećanje jajnika, dobivanje na težini, dispneja, oligurija i gastrointestinalni simptomi uključujući mučninu, povraćanje i dijareju.
English: REKOVELLE is used in the treatment of female infertility and in women undergoing assisted reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI).
Croatian: REKOVELLE se primjenjuje za liječenje neplodnosti u žena koje su podvrgnute postupcima medicinski potpomognute oplodnje kao što su in vitro fertilizacija (IVF) i intracitoplazmatska injekcija spermija (ICSI).
English: The instructions for use of the pen must be followed.
Croatian: Moraju se slijediti upute za primjenu brizgalice.
English: The cartridge may be used for several injections.
Croatian: Uložak se može koristiti za nekoliko injekcija.
English: • 72 micrograms/2.16 mL
Croatian: • 72 mikrograma/2,16 mL
English: REKOVELLE may be removed from the refrigerator, without being refrigerated again, and stored at or below 25 °C for up to 3 months including the period after first use.
Croatian: REKOVELLE se može izvaditi iz hladnjaka, bez ponovnog vraćanja u hladnjak, i čuvati na temperaturi od ili ispod 25 °C tijekom najviše 3 mjeseca, što uključuje period nakon prve primjene.
English: The pre-filled pen may be used for several injections.
Croatian: Napunjena brizgalica se može koristiti za nekoliko injekcija.
English: In case of ovarian hypo-response in the previous cycle, the daily dose in the subsequent cycle should be increased by 25% or 50%, according to the extent of response observed.
Croatian: Ako je odgovor jajnika u prethodnom ciklusu bio preslab, dnevnu je dozu u sljedećem ciklusu potrebno povećati za 25% ili 50%, s obzirom na primijećeni odgovor.
English: Dialing the dose - (Step 10)
Croatian: Odabir doze - (Korak 10)
English: When undergoing assisted reproductive technology treatment the possibility of having a multiple pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the quality of the embryos, and your age.
Croatian: Ukoliko ste podvrgnuti liječenju postupcima potpomognute oplodnje, mogućnost višeplodne trudnoće (blizanci) je većinom vezana uz broj embrija smještenih u Vašu maternicu, kakvoću embrija i Vašu dob.
English: It is not established whether or not treatment with gonadotropins increases the risk of these tumours in infertile women.
Croatian: Nije utvrđeno uzrokuje li liječenje gonadotropinima povećan rizik od ovih tumora u neplodnih žena.
English: • Carefully replace the outer needle cap over the needle with a firm push (A).
Croatian: • Čvrstim pritiskom pažljivo vratite vanjski zatvarač igle na iglu (A)
English: The pharmacokinetic profile of follitropin delta has been investigated in healthy female subjects and in IVF/ICSI patients undergoing COS.
Croatian: Farmakokinetički profil folitropina delta ispitan je u zdravih žena i IVF/ICSI bolesnica podvrgnutih kontroliranoj stimulaciji jajnika.
English: • The pen does not allow you to dial a larger dose than the dose that is left in the cartridge.
Croatian: • Brizgalica ne dozvoljava odabir doze koja je veća od količine preostalog lijeka u ulošku.
English: Multiple pregnancy and birth defects
Croatian: Višeplodna trudnoća i urođene mane
English: When undergoing assisted reproductive technology treatment, you are more likely to have a miscarriage than if you conceive naturally.
Croatian: Kada ste podvrgnuti liječenju postupcima potpomognute oplodnje, veća je vjerojatnost da će doći do pobačaja nego ako ste prirodno zanijeli.
English: Table 2 Adverse reactions in pivotal clinical trials System Organ Class
Croatian: Tablica 2 Nuspojave u pivotalnim kliničkim ispitivanjima Klasifikacija organskih sustava
English: • With the needle still pointing upwards (away from the face) press in the injection button all the way in until you see the number ‘0' lined up with the dose indicator.
Croatian: Korak 9: • S iglom još uvijek usmjerenom prema gore (dalje od lica) pritisnite dugme za ubrizgavanje i držite sve dok ne vidite da se broj “0” poravnao s pokazivačem doze.
English: In case of ovarian hyperresponse in the previous cycle, the daily dose in the subsequent cycle should be decreased by 20% or 33%, according to the extent of response observed.
Croatian: U slučaju prejakog odgovora jajnika u prethodnom ciklusu, dnevnu je dozu u sljedećem ciklusu potrebno sniziti za 20% ili 33%, s obzirom na primijećeni odgovor.
English: • See “Examples of how to dial a dose” at Page 20 to 211 if needed.
Croatian: • Pogledajte pod “Primjeri kako odabrati dozu” na stranicama 20 do 211 ukoliko je potrebno.
English: The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing controlled ovarian stimulation for ART than following natural conception.
Croatian: Incidencija gubitka trudnoće uslijed spontanog pobačaja ili abortusa je veća u bolesnica koje su na kontroliranoj stimulaciji jajnika u sklopu MPO postupaka, nego kod prirodnog začeća.
English: REKOVELLE is not indicated during pregnancy.
Croatian: REKOVELLE nije indiciran za primjenu u trudnoći.
English: • Do not tilt the pen during injection and removal from skin.
Croatian: • Nemojte naginjati brizgalicu tijekom injiciranja ili vađenja igle iz kože.
English: • Tilting the pen can cause the needle to bend or break off.
Croatian: • Naginjanje brizgalice može prouzročiti svijanje ili lom igle.
English: For instructions on the administration with the REKOVELLE injection pen, see the ”Instructions for Use” supplied with the pen.
Croatian: Za upute o primjeni REKOVELLE brizgalice za injekciju vidjeti ''Upute za uporabu'' priložene uz brizgalicu.
English: Instructions for use - REKOVELLE (follitropin delta) pre-filled pen
Croatian: Upute za uporabu - REKOVELLE (folitropin delta) napunjena brizgalica Važni podaci
English: (≥1/1,000 to <1/100)
Croatian: (≥1/1 000 do <1/100)
English: • 36 micrograms/1.08 mL
Croatian: • 36 mikrograma/1,08 mL
English: • 12 micrograms/0.36 mL
Croatian: • 12 mikrograma/0,36 mL
English: The instructions for using the injection pen supplied with the pen including loading the cartridge must be followed carefully.
Croatian: Upute za primjenu brizgalice za injekciju, priložene uz brizgalicu, uključujući upute za umetanje uloška, moraju se pažljivo slijediti.
English: Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, or acute pulmonary distress.
Croatian: Klinička procjena može otkriti hipovolemiju, hemokoncentraciju, poremećaj ravnoteže elektrolita, ascites, hemoperitoneum, pleuralne izljeve, hidrotoraks ili akutni plućni distres.
English: • you have malformations of the sexual organs which make a normal pregnancy impossible
Croatian: • ako imate nepravilnosti spolnih organa koje onemogućuju normalnu trudnoću
English: Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Croatian: Kontrolirana stimulacija jajnika u svrhu razvoja multiplih folikula u žena koje su podvrgnute postupcima medicinski potpomognute oplodnje (MPO) kao što su in vitro oplodnja (IVF, engl. in vitro fertilisation) ili ciklus intracitoplazmatske injekcije spermija (ICSI, engl. intracytoplasmic sperm injection cycle).
English: There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility treatment.
Croatian: Novotvorine reproduktivnog sustava Prijavljeni su slučajevi novotvorina jajnika i drugih organa reproduktivnog sustava, benignih kao i malignih, u žena koje su bile podvrgnute višestrukim režimima liječenja neplodnosti.
English: • you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine
Croatian: • ako ste alergični na folikulostimulirajući hormon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • The dose can be corrected either up or down without loss of medicine by turning the dose knob in either direction until the correct dose lines up with the dose indicator.
Croatian: • Doza se može korigirati prema više ili niže bez gubitka lijeka pomoću okretanja izbornika za podešavanje doze u bilo kojem smjeru sve dok se ispravna doza ne poravna s pokazivačem doze.
English: • Keep the pen cap on the pen when it is not in use.
Croatian: • Držite zatvarač brizgalice na brizgalici dok brizgalica nije u uporabi.
English: When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy outside the uterus (ectopic pregnancy) than if you conceive naturally.
Croatian: Kada ste podvrgnuti liječenju postupcima potpomognute oplodnje, veća je vjerojatnost da ćete imati vanmaterničnu trudnoću (ektopičnu trudnoću) nego ako ste prirodno zanijeli.
English: • If stored outside the refrigerator (at 2 °C to 25 °C), the pen will last up to 3 months including the in-use period.
Croatian: • Ukoliko se čuva izvan hladnjaka (na 2 °C do 25 °C), brizgalica se može koristiti najviše 3
English: In use: 28 days when stored at or below 25 °C.
Croatian: U primjeni: 28 dana kada se čuva na temperaturi od ili ispod 25°C.
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje česte (mogu se javiti u manje od 1 na 100 osoba)
English: REKOVELLE is designed for use in conjunction with the REKOVELLE injection pen provided separately.
Croatian: REKOVELLE je dizajniran za primjenu u kombinaciji s REKOVELLE brizgalicom za injekciju koja se dobiva odvojeno.
English: There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive technology treatment.
Croatian: Postoje podaci o uvrnuću jajnika (torzija jajnika) nakon liječenja postupcima potpomognute oplodnje.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Croatian: 4.2 Doziranje i način primjene Liječenje je potrebno započeti pod nadzorom liječnika s iskustvom u liječnju problema s plodnošću.
English: Renal and hepatic impairment REKOVELLE has not been studied in patients with moderate/severe renal or hepatic impairment.
Croatian: Oštećenje bubrega i jetre REKOVELLE nije ispitan na bolesnicama s umjerenim/teškim oštećenjem bubrega ili jetre.
English: There are no data from the inadvertent exposure to REKOVELLE in pregnant women.
Croatian: Nema podataka o izloženosti trudnih žena u slučaju nehotične primjene lijeka REKOVELLE.
English: REKOVELLE contains sodium
Croatian: REKOVELLE sadrži natrij
English: Known gastrointestinal symptoms associated with OHSS include abdominal pain, discomfort, and distension, nausea, vomiting and diarrhoea.
Croatian: Poznati gastrointestinalni simptomi povezani s OHSS-om uključuju bol, nelagodu i distenziju abdomena, mučninu, povraćanje i dijareju.
English: Split-dose diary
Croatian: Dnevnik podijeljenih doza
English: • If you dial the incorrect priming dose, the priming dose can be corrected either up or down without loss of medicine by turning the dose knob in either direction until the symbol of a droplet lines up with the dose indicator.
Croatian: • Ukoliko odaberete pogrešnu dozu za pripremu, doza za pripremu se može korigirati na više ili niže bez gubitka lijeka pomoću okretanja izbornika za podešavanje doze u bilo kojem smjeru, sve dok se simbol kapljice ne poravna s pokazivačem doze.
English: • you have fibroids of the uterus which make a normal pregnancy impossible.
Croatian: • ako imate fibroide u maternici koji onemogućuju normalnu trudnoću.
English: • you have been told by another doctor that pregnancy would be dangerous for you
Croatian: • Vam je drugi liječnik rekao da bi trudnoća za Vas mogla biti opasna • imate bolest bubrega ili jetre
English: - The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water for injections.
Croatian: - Drugi sastojci su fenol, polisorbat 20, L-metionin, natrijev sulfat dekahidrat, natrijev hidrogenfosfat dodekahidrat, koncentrirana fosfatna kiselina, natrijev hidroksid i voda za injekcije.
English: Ovarian and other reproductive system tumours
Croatian: Tumori jajnika i tumori drugih reproduktivnih organa
English: Injecting the dose - (Step 11 to 12)
Croatian: Injiciranje doze - (Korak 11 do 12) Važno:
English: 18 and 2 lines (Dial to 18 plus 2 clicks)
Croatian: 18 i 2 linije (Okrenite do 18 plus 2 klika)
English: • You can inject the medicine left in the pen and complete the prescribed dose with a new pen (split-dose) or use a new pen to give the full prescribed dose.
Croatian: • Možete injicirati količinu koja je preostala u brizgalici, a ostatak do pune propisane doze iz nove brizgalice (podijeljena doza) ili upotrijebiti novu brizgalicu za injiciranje pune propisane doze.
English: Polycystic ovarian syndrome patients with anovulatory disorders Anovulatory patients with polycystic ovarian syndrome have not been studied.
Croatian: Bolesnice sa sindromom policističnih jajnika i anovulacijskim poremećajem Bolesnice koje nemaju ovulaciju, a imaju sindrom policističnih jajnika nisu bile uključene u ispitivanje.
English: See “Examples of how to dial a dose” at Page 20 to 211.
Croatian: Vidjeti „Primjeri kako podesiti dozu“ na stranicama 20 do 211.
English: • Store the pen in a refrigerator at 2 °C to 8 °C.
Croatian: • Čuvajte brizgalicu u hladnjaku na temperaturi od 2 °C do 8 °C.
English: If you have any questions or problems related to the pen, contact your healthcare provider or local representative of the marketing authorisation holder (please refer to patient information leaflet for contact details).
Croatian: • Ukoliko imate bilo kakvo pitanje ili problem vezan uz brizgalicu, kontaktirajte Vašeg zdravstvenog djelatnika ili lokalnog predstavnika nositelja odobrenja (molimo vidjeti uputu o lijeku za podatke o kontaktu).