FrancophonIA/ELRC3.0 huggingface dataset:
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 60 mL/min in any individual receiving Truvada for pre-exposure prophylaxis, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Croatian: Ako su u bilo koje osobe koja prima Truvadu za predekspozicijsku profilaksu fosfati u serumu < 1,5 mg/dL (0,48 mmol/L) ili se klirens kreatinina smanji na < 60 mL/min, unutar jednoga tjedna treba ponovno ocijeniti funkciju bubrega, kao i izmjeriti koncentracije glukoze u krvi, kalija u krvi i glukoze u mokraći (vidjeti dio 4.8, proksimalna tubulopatija).
English: AUC: ↑ 143% Cmax:↑ 72% Cmin: ↑ 300%
Croatian: Voksilaprevir: AUC: ↑ 143% Cmax:↑ 72% Cmin: ↑ 300%
English: Protease inhibitors Atazanavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Croatian: Antiretrovirusni lijekovi Inhibitori proteaze Atazanavir/Ritonavir/ Tenofovirdizoproksil (300 mg q.d./100 mg q.d./245 mg q.d.)
English: Darunavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Croatian: Darunavir/Ritonavir/ Tenofovirdizoproksil (300 mg q.d./100 mg q.d./245 mg q.d.)
English: AUC: ↓ 11% (↓ 14 to ↓ 7) Cmax: ↓ 7% (↓ 13 to ↓ 0)
Croatian: AUC: ↓ 11% (od ↓ 14 do ↓ 7) Cmax: ↓ 7% (od ↓ 13 do ↓ 0) Cmin: NI
English: AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14)
Croatian: AUC: ↑ 5% (od ↓ 2 do ↑ 13) Cmax: ↑ 5% (od ↓ 3 do ↑ 14) Cmin: NI
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Croatian: Sigurnost tenofovirdizoproksila pri istovremenoj primjeni sa sofosbuvirom/velpatasvirom/v oksilaprevirom i farmakokinetičkim pojačivačem (npr. ritonavirom ili kobicistatom) nije ustanovljena.
English: AUC: ↑ 4% (↓ 3 to ↑ 11) Cmax: ↑ 3% (↓ 3 to ↑ 9)
Croatian: AUC: ↑ 4% (od ↓ 3 do ↑ 11) Cmax: ↑ 3% (od ↓ 3 do ↑ 9) Cmin: NI
English: AUC: ↓ 5% (↓ 9 to ↓ 1) Cmax: ↓ 11% (↓ 17 to ↓ 5)
Croatian: AUC: ↓ 5% (od ↓ 9 do ↓ 1) Cmax: ↓ 11% (od ↓ 17 do ↓ 5) Cmin: NI
English: If serum phosphate is confirmed to be < 3.0 mg/dL (0.96 mmol/L) in any paediatric patient receiving Truvada, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Croatian: Ako su u bilo kojeg pedijatrijskog bolesnika koji prima Truvadu fosfati u serumu < 3,0 mg/dL (0,96 mmol/L), unutar jednog tjedna treba ponovno procijeniti funkciju bubrega, kao i izmjeriti koncentracije glukoze u krvi, kalija u krvi i glukoze u mokraći (vidjeti dio 4.8, proksimalna tubulopatija).
English: Only samples from subjects randomized to Truvada were evaluated for detectable plasma or intracellular tenofovir disoproxil-DP levels.
Croatian: Mjerljive razine tenofovirdizoproksila-DP-a u plazmi ili unutar stanica bile su procijenjene samo u uzorcima ispitanika randomiziranih na primanje Truvadu.
English: The use of Truvada is not recommended in individuals under the age of 18 years with renal impairment (see section 4.2).
Croatian: Ne preporučuje se primjena Truvade u osoba s oštećenjem bubrega mlađih od 18 godina (vidjeti dio 4.2).
English: AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22)
Croatian: AUC: ↓ 1% (od ↓ 8 do ↑ 6) Cmax: ↑ 7% (od ↓ 6 do ↑ 22) Cmin: NI
English: ORAL CONTRACEPTIVES Norgestimate/Ethinyl oestradiol/Tenofovir disoproxil
Croatian: Norgestimat/Etinilestradiol/ Tenofovirdizoproksil
English: While taking Truvada to reduce the risk of getting HIV:
Croatian: Dok uzimate Truvadu za smanjenje rizika od dobivanja HIV-a:
English: AUC: ↑ 39% Cmax: ↑ 48%
Croatian: AUC: ↑ 39% Cmax: ↑ 48% Cmin: ↑ 47%
English: AUC: ↓ 7% (↓ 13 to ↓ 1) Cmax: ↓ 11% (↓ 20 to ↑ 1)
Croatian: AUC: ↓ 7% (od ↓ 13 do ↓ 1) Cmax: ↓ 11% (od ↓ 20 do ↑ 1) Cmin: NI
English: AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24)
Croatian: AUC: ↓ 4% (od ↓ 32 do ↑ 34) Cmax: ↓ 5% (od ↓ 27 do ↑ 24) Cmin: NI
English: (may affect up to 1 in 10 people)
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba):
English: Antimycobacterials Rifampicin/Tenofovir disoproxil
Croatian: Antimikobakterijski lijekovi Rifampicin/
English: 35 kg, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects.
Croatian: • Također se primjenjuje za liječenje HIV-a u adolescenata u dobi od 12 do manje od 18 godina, tjelesne težine najmanje 35 kg, te su već liječeni drugim lijekovima za HIV koji više nisu učinkoviti ili su izazvali nuspojave.
English: • Know your hepatitis B virus (HBV) infection status before starting Truvada.
Croatian: • Prije nego što počnete uzimati Truvadu, morate znati jeste li zaraženi virusom hepatitisa B (HBV).
English: AUC: ↓ 4% (↓ 7 to ↓ 1) Cmax: ↓ 4% (↓ 9 to ↑ 2)
Croatian: AUC: ↓ 4% (od ↓ 7 do ↓ 1) Cmax: ↓ 4% (od ↓ 9 do ↑ 2) Cmin: NI
English: AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6)
Croatian: AUC: ↓ 2% (od ↓ 5 do ↑ 0) Cmax: ↓ 1% (od ↓ 7 do ↑ 6) Cmin: NI
English: Only Case or Cohort samples from subjects randomised to either tenofovir disoproxil 245 mg or Truvada were evaluated for detectable plasma tenofovir levels.
Croatian: Mjerljive razine tenofovira u plazmi bile su ispitane samo u uzorcima ‚slučajeva' i ‚kohorte' uzetih od ispitanika randomiziranih ili u skupinu koja je primala tenofovirdizoproksil u dozi od 245 mg ili u skupinu koja je primala Truvadu.
English: AUC: ↓ 3% (↓ 8% to ↑ 15) Cmax: ↓ 24% (↓ 44 to ↓ 12)
Croatian: AUC: ↓ 3% (od ↓ 8% do ↑ 15) Cmax: ↓ 24% (od ↓ 44 do ↓ 12) Cmin: NI
English: AUC: ↓ 9% (↓ 16 to ↓ 1) Cmax: ↓ 7% (↓ 22 to ↑ 11)
Croatian: AUC: ↓ 9% (od ↓ 16 do ↓ 1) Cmax: ↓ 7% (od ↓ 22 do ↑ 11) Cmin: NI
English: Truvada [Outer packaging only]
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Truvada [Samo vanjsko pakiranje]
English: Truvada is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents (see sections 4.2, 4.4 and 5.1).
Croatian: NRTIs) ili toksičnošću koja onemogućuje primjenu lijekova prve linije (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Pre-exposure prophylaxis
Croatian: IMUNOSUPRESIVI
English: FTC/tenofovir disoproxil Groupa Tenofovir disoproxil Groupa
Croatian: FTC/tenofovirdizopr oksila
English: • Truvada is used to treat Human Immunodeficiency Virus 1 (HIV-1) infection in adults • It is also used to treat HIV in adolescents aged 12 to less than 18 years who weigh at least
Croatian: • Truvada se primjenjuje za liječenje infekcije virusom humane imunodeficijencije tipa 1 (HIV-1) u odraslih
English: Emtricitabine: AUC: ↔
Croatian: Velpatasvir: AUC: ↔
English: HIV paediatric renal educational brochure:
Croatian: Edukacijska brošura o HIV-u i renalnoj funkciji u djece
English: • You must be HIV negative before you start to take Truvada to reduce the risk of getting
Croatian: • Prije nego što počnete uzimati Truvadu radi smanjenja rizika od dobivanja HIV-a, morate biti HIV-negativni.
English: Efavirenz/Tenofovir disoproxil
Croatian: Efavirenz/ Tenofovirdizoproksil
English: Seroconversions / Na Incidence per 100 person-years (95% CI)
Croatian: Serokonverzije / N Smanjenje relativnog rizika (95% CI)b
English: • muscle weakness
Croatian: • mišićna slabost
English: Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Croatian: Tenofovirdizoproksil (200 mg/245 mg q.d.)1
English: Gilead Sciences Ltd. Tel: + 44 (0) 8000 113 700
Croatian: Gilead Sciences, S.L. Tel: + 34 (0) 91 378 98 30
English: AUC: ↔ Cmax: ↔
Croatian: Emtricitabin: AUC: ↔ Cmax: ↔
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.
Croatian: Sofosbuvir/velpatasvir (400 mg/100 mg q.d.) + raltegravir (400 mg b.i.d) + emtricitabin/ tenofovirdizoproksil (200 mg/245 mg q.d.)
English: • difficulty with movement
Croatian: • otežana pokretljivost.
English: GS-01-934 Treatment for 48 weeks
Croatian: Liječenje u trajanju od 48 tjedana
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Croatian: Povećane koncentracije tenofovira u plazmi uslijed istovremene primjene tenofovirdizoproksila, sofosbuvira/velpatasvira/voksi laprevira i darunavira/ritonavira mogu pojačati nuspojave vezane uz tenofovirdizoproksil, uključujući poremećaje bubrega.
English: BMD Z-scores declined by -0.012 for lumbar spine and by -0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks.
Croatian: U 64 ispitanika koji su primali tenofovirdizoproksil tijekom 96 tjedana z-vrijednosti BMD-a smanjile su se za -0,012 u području lumbalne kralježnice, a z-vrijednosti BMD-a cijelog tijela smanjile su se za -0,338. zvrijednosti BMD-a nisu prilagođene s obzirom na visinu i težinu.
English: + Darunavir/Ritonavir (800 mg q.d./100 mg q.d.)
Croatian: Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.) + Darunavir/Ritonavir (800 mg q.d./100 mg q.d.) + Emtricitabin/
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Croatian: Povećane koncentracije tenofovira u plazmi uslijed istovremene primjene tenofovirdizoproksil, sofosbuvira/velpatasvira i darunavira/ritonavira mogu pojačati nuspojave vezane uz tenofovirdizoproksil, uključujući poremećaje bubrega.
English: + Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
Croatian: Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.) + Emtricitabin/Rilpivirin/ Tenofovirdizoproksil (200 mg/25 mg/245 mg q.d.)
English: + Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Croatian: Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.) + Efavirenz/Emtricitabin/ Tenofovirdizoproksil (600 mg/200 mg/245 mg q.d.)
English: Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Croatian: Sofosbuvir/velpatasvir (400 mg/100 mg q.d.) + efavirenz/emtricitabin/ tenofovirdizoproksil (600 mg/200 mg/245 mg q.d.)
English: AUC: ↔ Cmax: ↓ 30%
Croatian: Sofosbuvir: AUC: ↔ Cmax: ↓ 30% Cmin: NP
English: Children and adolescents (under 18 years of age)
Croatian: Djeca i adolescenti (ispod 18 godina starosti)
English: The absolute bioavailability is about 64%.
Croatian: Apsolutna bioraspoloživost iznosi oko 64%.
English: It must be discarded afterwards.
Croatian: Nakon toga se mora baciti.
English: OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event.
Croatian: OHSS može napredovati brzo (unutar 24 sata do nekoliko dana) do ozbiljnog medicinskog događaja.
English: You will need it to throw away (dispose of) the needle after injecting the medicine.
Croatian: Trebat će Vam za sigurno odbacivanje (zbrinjavanje) igle nakon injiciranja lijeka.
English: How do I know that the injection is complete?
Croatian: Kako znam da je injiciranje završeno?
English: • Read Step 11 and 12 at Page 14 to 151 before giving your injection.
Croatian: • Pročitajte Korak 11 i 12 na stranicama 14 do 151 prije nego si injicirate lijek.
English: The individual daily dose is to be maintained throughout the stimulation period.
Croatian: Individualnu dnevnu dozu je potrebno održavati tijekom perioda stimulacije.
English: Why do I have to count to 5 while holding the injection button?
Croatian: Zašto moram brojiti do 5 dok pritišćem dugme za injiciranje?
English: Multiple pregnancy may lead to medical complications for you and your babies.
Croatian: Višeplodne trudnoće mogu dovesti do medicinskih komplikacija za Vas i Vašu djecu.
English: Your doctor will decide if you can give yourself further doses of this medicine at home, but only after receiving adequate training.
Croatian: Vaš će liječnik odlučiti možete li si daljnje doze ovoga lijeka davati sami kod kuće, ali samo nakon odgovarajuće obuke.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljni informacije o ovome lijek dostupne su na internetskoj stranici Europske Agencije za lijekove: http://www.ema.europa.eu.
English: This medicine is not indicated in children and adolescents.
Croatian: Ovaj se lijek ne primjenjuje u djece i adolescenata.
English: Furthermore, the syndrome may be more severe and more protracted if pregnancy occurs.
Croatian: Nadalje, sindrom može biti teži i dugotrajniji ako dođe do trudnoće.
English: Talk to your doctor if you:
Croatian: Razgovarajte s Vašim liječnikom ako:
English: • See “Disposal” at Page 181.
Croatian: • Pogledajte “Odlaganje” na stranici 181.
English: Follow the instructions carefully even if you have used a similar injection pen before.
Croatian: Pažljivo slijedite upute, čak i ako ste ranije koristili sličnu brizgalicu za injekciju.
English: The pen is available in 3 different strengths:
Croatian: Brizgalica je dostupna u 3 različite jačine:
English: The needles are for single-use only.
Croatian: Igle su samo za jednokratnu uporabu.
English: Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik i u dozi koju Vam je liječnik propisao.
English: • properly labeled to warn of hazardous waste inside the container.
Croatian: • propisno je označen u svrhu upozorenja na opasni otpad koji se unutra nalazi.
English: 0.66 (priming dose)
Croatian: 0,66 (doza pripreme)
English: This will make sure you get your full dose.
Croatian: To će osigurati primanje Vaše pune doze.
English: • If a broken needle remains stuck in the body or remains under the skin, get medical help right away.
Croatian: • Ukoliko slomljena igla ostane zaglavljena u tijelu ili ostane ispod kože, odmah potražite medicinsku pomoć.
English: This is when your follicles develop too much and become large cysts.
Croatian: To je kada se folikuli previše razviju i postanu velike ciste.
English: Therefore the AMH result from a blood sample (taken within the last 12 months) should be available before you start treatment.
Croatian: Stoga vrijednost AMH iz uzorka krvi (uzet unutar zadnjih 12 mjeseci) mora biti dostupna prije početka liječenja.
English: • You will hear or feel a click when the needle is safely on.
Croatian: • Čut ćete ili osjetiti klik kad je igla sigurno spojena.
English: Change the needle.
Croatian: Promijenite iglu.
English: If your body´s response to treatment is too weak or too strong, your doctor may decide to stop treatment with REKOVELLE.
Croatian: Ako je odgovor Vašeg tijela na liječenje preslab ili prejak, Vaš liječnik može odlučiti zaustaviti liječenje lijekom REKOVELLE.
English: How are injections given
Croatian: Kako se daju injekcije
English: (Dial to 11)
Croatian: (Okrenite do 11)
English: The effects of taking too much of this medicine are unknown.
Croatian: Učinak u slučaju uzimanja previše ovoga lijeka nije poznat.
English: It most often occurs after hormonal treatment has been discontinued.
Croatian: Najčešće se pojavi nakon završetka hormonalne terapije.
English: Do not touch the injection button yet.
Croatian: Još uvijek nemojte dirati dugme za ubrizgavanje.
English: • Do not store the pen in extreme temperatures, direct sunlight or very cold conditions, such as in a car or freezer.
Croatian: • Nemojte čuvati brizgalicu nana ekstremnim temperaturama, direktnom sunčevom svjetlu ili u vrlo hladnim uvjetima, kao npr. u automobilu ili zamrzivaču.
English: • Perform Step 7 to 9 even if you do not see air bubbles.
Croatian: • Provedite Korake 7 do 9 iako ne primijećujete mjehuriće zraka.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and local tolerance.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza i lokalne podnošljivosti.
English: The patients were up to 40 years of age and had regular menstrual cycles presumed to be ovulatory.
Croatian: Bolesnice su bile do 40 godina starosti i imale redovite menstrualne cikluse za koje se pretpostavljalo da uključuju ovulaciju.
English: What REKOVELLE is and what it is used for 2.
Croatian: Što je REKOVELLE i za što se koristi 2.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove, uključujući one dobivene bez recepta.
English: • Always use a new needle for each injection.
Croatian: • Uvijek upotrijebite novu iglu za svako injiciranje.
English: What REKOVELLE is and what it is used for
Croatian: Što je REKOVELLE i za što se koristi
English: • Call your healthcare provider if you have questions about how to calculate your split-dose.
Croatian: • Nazovite Vašeg zdravstvenog djelatnika ukoliko imate pitanja o tome kako izračunati Vašu podijeljenu dozu.
English: Tell your doctor if you think this applies to you.
Croatian: Obavijestite Vašeg liječnika ako se ovo odnosi na Vas.
English: Clear and colourless solution with a pH of 6.0-7.0.
Croatian: Bistra i bezbojna otopina s pH 6,0-7,0.
English: 2300 Copenhagen S Denmark
Croatian: 2300 Copenhagen S
English: Page numbers refer to the printed Instructions For Use booklet and not to actual page numbers in this document.
Croatian: Brojevi stranica se odnose na printanu uputu o korištenju i ne odnose se na brojeve stranica u ovom dokumentu.
English: Gonadotropins are involved in reproduction and fertility.
Croatian: Gonadotropini utječu na reprodukciju i plodnost.
English: • You may also screw on the needle.
Croatian: • Također možete zavrnuti iglu.
English: Your doctor may ask you to stop using this medicine (see section 4).
Croatian: Vaš liječnik može zatražiti da prestanete primjenjivati ovaj lijek (vidjeti dio 4).
English: • If the pen has already been used proceed directly to Step 10.
Croatian: • Ako ste već koristili ovu brizgalicu, nastavite izravno na Korak 10.
English: The risk of having a side effect is described by the following categories:
Croatian: Rizik od nuspojava je opisan prema sljedećim kategorijama:
English: The first injection should be performed under direct medical supervision.
Croatian: Prvu je injekciju potrebno primijeniti pod direktnim medicinskim nadzorom.
English: Treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events.
Croatian: Liječenje gonadotropinima može nadalje povećati rizik od pogoršanja ili pojave takvih događaja.
English: Contact
Croatian: Kontakt
English: mcg mcg/kg
Croatian: μg μg/kg
English: D-24109 Kiel Germany
Croatian: D-24109 Kiel
English: Also, as a consequence of the hormonal changes during pregnancy, late development of OHSS can occur.
Croatian: Također, zbog posljedica hormonalnih promjena tijekom trudnoće, može doći do kasnog razvoja
English: At the end of the treatment any unused solution must be discarded.
Croatian: Na kraju liječenja, neiskorištena otopina mora se baciti.
English: There may be state or local laws about how you should throw away used needles.
Croatian: Možda postoje državni ili lokalni propisi o odlaganju iskorištenih igala.
English: • made of a heavy-duty plastic,
Croatian: • je izrađen od čvrste plastike,
English: The dosing regimen is specific for REKOVELLE and the microgram dose cannot be applied to other gonadotropins.
Croatian: Režim doziranja je specifičan za REKOVELLE i doza u mikrogramima se ne može primijeniti na druge gonadotropine.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, ATC code: G03GA10
Croatian: Farmakoterapijska skupina: Spolni hormoni i modulatori spolnog sustava, gonadotopini, ATK oznaka: G03GA10
English: For calculation of the REKOVELLE dose, the body weight is to be measured without shoes and overcoat just prior to start of stimulation.
Croatian: Za računanje doze lijeka REKOVELLE, tjelesnu je težinu potrebno mjeriti bez cipela i ogrtača, prije samog početka stimulacije.
English: Then slowly remove the needle from the injection site by pulling it straight out of the skin.
Croatian: Zatim polako izvucite iglu s mjesta injiciranja tako što ćete ju povući ravno iz kože.
English: Your doctor will monitor the effect of REKOVELLE treatment, and treatment is stopped when an appropriate number of egg sacs are present.
Croatian: Vaš će liječnik pratiti učinak liječenja lijekom REKOVELLE, a liječenje se obustavlja kada se razvije dovoljan broj jajnih vrećica.
English: • Do not try to repair a damaged pen.
Croatian: • Nemojte pokušati popravljati oštećenu brizgalicu.
English: The first injection of this medicine should be given under the supervision of a doctor or a nurse.
Croatian: Prvu injekcije ovog lijeka je potrebno dati pod nadzorom liječnika ili medicinske sestre.
English: Although limited, data did not indicate a need for a different dosing regimen of REKOVELLE in this patient population (see section 4.4).
Croatian: Iako ograničeni, podaci nisu ukazali na potrebu za drugačijim režimom doziranja lijeka REKOVELLE u ovoj populaciji bolesnica (vidjeti dio 4.4).
English: Safety - immunogenicity
Croatian: Sigurnost - imunogenost
English: EXP After first use: Use within 28 days.
Croatian: EXP Nakon prve primjene: Upotrijebiti unutar 28 dana.
English: If the number in column C is 9.67, round your remaining dose to 9.66.
Croatian: Ako je broj u stupcu C 9,67, zaokružite Vašu preostalu dozu na 9,66.
English: Get help from a person with good eyesight who is trained to use the pen.
Croatian: Potražite pomoć osobe s dobrim vidom koja je obučena za rad s brizgalicom.
English: Write down your prescribed dose in column A.
Croatian: Upišite Vašu propisanu dozu u stupac A.
English: If you do not have a sharps disposal container, you may use a household container that is:
Croatian: Ukoliko nemate spremnik za odlaganje oštrih predmeta, možete upotrijebiti kućni spremnik koji:
English: Frequently Asked Questions (FAQ)
Croatian: Često postavljena pitanja
English: It must not be refrigerated again and must be discarded if it has not been used after 3 months.
Croatian: Ne smije ga se ponovno vratiti u hladnjak, te se mora baciti ako se ne iskoristi unutar 3 mjeseca.
English: • The REKOVELLE pre-filled pen and the needles are for use by only one person and should not be shared with others.
Croatian: • REKOVELLE napunjenu brizgalicu i igle smije upotrebljavati samo jedna osoba i ne smiju se dijeliti s drugima.
English: The maximum daily dose is 24 micrograms.
Croatian: Maksimalna dnevna doza je 24 mikrograma.
English: Clinically significant interactions with other medicinal products have neither been reported during REKOVELLE therapy, nor are expected.
Croatian: Klinički značajne interakcije s drugim lijekovima nisu ni prijavljene tijekom terapije lijekom REKOVELLE, niti ih se očekuje.
English: • you have had an early menopause
Croatian: • ako ste u ranoj menopauzi
English: • Each number is separated by two lines, each line is equal to one increment of 0.33 micrograms.
Croatian: • Svaki broj je odvojen dvjema linijama, svaka linija odgovara jednom povećanju od 0,33 mikrograma.
English: If you forget to use REKOVELLE
Croatian: Ako ste zaboravili primijeniti REKOVELLE
English: What you need to know before you use REKOVELLE
Croatian: Što morate znati prije nego počnete primjenjivati REKOVELLE
English: When you feel a light resistance it is safely on.
Croatian: Kad osjetite blagi otpor, ona je sigurno spojena.
English: Is the priming step necessary before each injection?
Croatian: Da li je korak pripreme brizgalice potrebno provesti prije svakog injiciranja?
English: There may be a degree of interpatient variability in response to FSH administration, with poor response to FSH in some patients and exaggerated response in others.
Croatian: Moguće je da postoji stupanj varijabilnosti u odgovoru na primjenu FSH među bolesnicama, sa slabim odgovorom na FSH u nekih bolesnica i pretjeranim u drugih.