FrancophonIA/ELRC3.0 huggingface dataset:
English: • While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
Croatian: • Dok držite bočicu okrenutu naopako, lagano lupnite štrcaljku kako bi se mjehurići zraka podigli na vrh.
English: If the plastic cap is loose or missing, do not use the vial.
Croatian: Ako plastična kapica nije dobro pričvršćena ili nedostaje, nemojte koristiti bočicu.
English: What Esperoct is and what it is used for What Esperoct is
Croatian: Što je Esperoct i za što se koristi
English: The reconstituted solution must be clear and colourless.
Croatian: Pripremljena otopina za primjenu mora biti bistra i bezbojna.
English: If you cannot use the reconstituted solution immediately, it should be used within 4 hours when stored at room temperature (up to 30°C) and within 24 hours when stored in a refrigerator (2°C - 8°C).
Croatian: Ako ne možete odmah primijeniti pripremljenu otopinu, morate je upotrijebiti unutar 4 sata ako se čuva na sobnoj temperaturi (do 30°C), odnosno unutar 24 sata ako se čuva u hladnjaku (2°C-8°C).
English: Early haemarthrosis, mild muscle bleeding or mild oral bleeding
Croatian: Početna hemartroza, blago krvarenje u mišiću ili blago krvarenje u usnoj šupljini
English: Record the date when you store Esperoct at room temperature on the carton.
Croatian: Na kutiji lijeka zabilježite datum početka čuvanja lijeka Esperoct na sobnoj temperaturi.
English: Factor VIII level required (%) (IU/dL)a
Croatian: Potrebna razina faktora VIII (IU/dl ili % normalne vrijednosti)a
English: Severe or life-threatening haemorrhages
Croatian: Teška krvarenja ili po život opasna krvarenja
English: • Immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
Croatian: • Odmah spojite potisnik klipa sa štrcaljkom tako da ga navijate u smjeru kazaljke na satu u klip koji se nalazi u napunjenoj štrcaljki, sve dok ne osjetite otpor.
English: Minor surgery
Croatian: Manji kirurški zahvat
English: Allergic-type hypersensitivity reactions are possible with Esperoct.
Croatian: Kod primjene lijeka Esperoct moguća je pojava reakcija preosjetljivosti alergijskog tipa.
English: Maximum factor VIII activity (IU/dL)a t1/2 (hours)
Croatian: (IU/dl)a t1/2 (sati)
English: If you touch the sides or the thread, germs from your fingers can be transferred.
Croatian: Ako dotaknete bočne strane ili navoj, može doći do prijenosa mikroorganizama s Vaših prstiju.
English: • Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
Croatian: • Držite potisnik klipa pritisnut do kraja i nježno vrtite bočicu dok se sav prašak ne otopi.
English: Polysorbate 80
Croatian: L-histidin saharoza polisorbat 80
English: Esperoct contains the active substance turoctocog alfa pegol and is a long-acting recombinant coagulation factor VIII product.
Croatian: Esperoct sadrži djelatnu tvar turoktokog alfa pegol, a to je dugodjelujući rekombinantni koagulacijski faktor VIII.
English: The frequencies of adverse reactions as observed in 270 unique subjects across five prospective, multi-centre clinical studies in previously treated patients (PTPs) with severe haemophilia A (<1% endogenous factor VIII activity) and no history of inhibitors are listed in table 3.
Croatian: Učestalost nuspojava opažena u 270 jedinstvenih ispitanika kroz pet prospektivnih multicentričnih kliničkih ispitivanja u prethodno liječenih bolesnika (engl. previously treated patients, PTP) s teškom hemofilijom A (<1% aktivnosti endogenog faktora VIII) i bez povijesti inhibitora navedena je u tablici 3. Kategorije nuspojava predstavljene su u tablici 3 prema MedDRA klasifikaciji organskih sustava (organski sustav i preporučeni pojam).
English: If the syringe cap is loose or missing, do not use the pre-filled syringe.
Croatian: Ako zatvarač štrcaljke nije dobro pričvršćen ili nedostaje, nemojte koristiti napunjenu štrcaljku.
English: Each pack of Esperoct contains a vial with white to off-white powder, a 4 mL pre-filled syringe with a clear colourless solvent, a plunger rod and a vial adapter.
Croatian: Jedno pakiranje lijeka Esperoct sadrži bočicu s bijelim ili bjelkastim praškom, napunjenu štrcaljku s 4 ml bistrog i bezbojnog otapala, potisnik klipa i nastavak za bočicu.
English: Do not take the vial adapter out of the protective cap with your fingers.
Croatian: Nemojte prstima vaditi nastavak za bočicu iz zaštitnog omota.
English: A maximum single dose of Esperoct at 75 IU/kg and a maximum total dose of 200 IU/kg/24 hours may be administered.
Croatian: Maksimalna jednokratna doza lijeka Esperoct je 75 IU/kg, a maksimalna ukupna doza je 200 IU/kg/24 sata.
English: • If you do not need to use all of the reconstituted medicine from the vial,
Croatian: • Ako ne trebate upotrijebiti cjelokupni lijek pripremljen za primjenu iz bočice, upotrijebite skalu na štrcaljki za izvlačenje
English: The active substance turoctocog alfa pegol is a covalent conjugate of the protein turoctocog alfa* with a 40 kDa polyethylene-glycol (PEG).
Croatian: Djelatna tvar, turoktokog alfa pegol, kovalentni je konjugat proteina turoktokog alfa* s polietilenglikolnim (PEG) dijelom od 40 kDa.
English: Esperoct 500 IU powder and solvent for solution for injection Esperoct 1000 IU powder and solvent for solution for injection Esperoct 1500 IU powder and solvent for solution for injection Esperoct 2000 IU powder and solvent for solution for injection Esperoct 3000 IU powder and solvent for solution for injection turoctocog alfa pegol (pegylated human coagulation factor VIII (rDNA)) This medicine is subject to additional monitoring.
Croatian: Esperoct 500 IU prašak i otapalo za otopinu za injekciju Esperoct 1000 IU prašak i otapalo za otopinu za injekciju Esperoct 1500 IU prašak i otapalo za otopinu za injekciju Esperoct 2000 IU prašak i otapalo za otopinu za injekciju Esperoct 3000 IU prašak i otapalo za otopinu za injekciju turoktokog alfa pegol (pegilirani ljudski koagulacijski faktor VIII (rDNK))
English: Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).
Croatian: Liječenje i profilaksa krvarenja u bolesnika s hemofilijom A (urođeni nedostatak faktora VIII) u dobi od 12 i više godina.
English: Vial adapter Protective cap
Croatian: Nastavak za bočicu Zaštitni omot
English: Do not open the equipment until you are ready to use it. Do not use the equipment if it has been dropped, or if it is damaged.
Croatian: Nemojte koristiti pribor ako je pao ili ako je oštećen.
English: Record the beginning of storage at room temperature on the product carton.
Croatian: Na kutiji lijeka zabilježite datum početka čuvanja lijeka na sobnoj temperaturi.
English: Plasma factor VIII activity levels should be maintained at or above the described plasma levels (in IU per dL or % of normal).
Croatian: Smjernice za doziranje lijeka Esperoct za liječenje po potrebi i liječenje epizoda krvarenja navedene su u tablici 1. Razine aktivnosti faktora VIII u plazmi treba održavati na ili iznad opisanih razina u plazmi (u IU po dl ili % normalne vrijednosti).
English: How to store Esperoct
Croatian: Kako primjenjivati Esperoct
English: Esperoct is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
Croatian: Esperoct se primjenjuje intravenski nakon rekonstitucije praška otapalom koje dolazi u štrcaljki.
English: Do not shake the vial as this will cause foaming.
Croatian: Bočicu nemojte tresti jer će to izazvati pjenjenje.
English: • rash, hives, weals or itching
Croatian: • osip, koprivnjača ili svrbež
English: The solution should be clear and colourless.
Croatian: Otopina mora biti bistra i bezbojna.
English: • Turn the syringe with the vial upside down.
Croatian: • Okrenite štrcaljku s bočicom naopako.
English: The reconstituted solution should be stored in the vial.
Croatian: Rekonstituiranu otopinu čuvati u bočici.
English: • Take the vial, the vial adapter and the pre-filled syringe out of the carton.
Croatian: • Izvadite bočicu, nastavak za bočicu i napunjenu štrcaljku iz kutije.
English: Read the package leaflet before use Intravenous use, after reconstitution
Croatian: Za intravensku primjenu, nakon rekonstitucije
English: 12 to below18 years N=3
Croatian: 12 do mlađi od 18 godina N=3
English: use the scale on the syringe to withdraw
Croatian: Pričvrstite potisnik klipa na štrcaljku
English: pH: 6.9.
Croatian: Otapalo je bistro i bezbojno. pH: 6,9.
English: Powder: 3000 IU turoctocog alfa pegol (approx. 750 IU/mL after reconstitution),
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Prašak: 3000 IU turoktokog alfa pegola (pribl. 750 IU/ml nakon rekonstitucije),
English: The solvent is a sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Otapalo je 0,9%-tna (9 mg/ml) otopina natrijevog klorida za injekciju.
English: See “Development of ‘FVIII inhibitors' (antibodies)” in section 2.
Croatian: Pogledajte u dijelu 2 “Razvoj „inhibitora FVIII“ (antitijela)”.
English: How to use Esperoct
Croatian: Kako čuvati Esperoct
English: Vial with Esperoct powder
Croatian: Bočica s praškom lijeka Esperoct
English: Powder and solvent for solution for injection Pack contains: 1 powder vial, 4 mL solvent in a pre-filled syringe, 1 plunger rod and 1 vial adapter
Croatian: Pakiranje sadrži: 1 bočicu s praškom, 4 ml otapala u napunjenoj štrcaljki, 1 potisnik klipa i 1 nastavak za bočicu
English: Single-dose pharmacokinetic parameters of Esperoct are listed in table 4.
Croatian: Farmakokinetički parametri jednokratne doze lijeka Esperoct navedeni su u tablici 4. Primjena lijeka Esperoct u djece mlađe od 12 godina nije indicirana.
English: The following side effects have been observed with Esperoct
Croatian: Pri primjeni lijeka Esperoct primijećene su sljedeće nuspojave
English: After the injection, safely dispose of the syringe with the infusion set and the vial with the vial adapter.
Croatian: Nakon injiciranja zbrinite štrcaljku s infuzijskim setom te bočicu s nastavkom za bočicu na siguran način.
English: If you touch the syringe tip, germs from your fingers can be transferred.
Croatian: Ako dotaknete vrh štrcaljke, može doći do prijenosa mikroorganizama s Vaših prstiju.
English: If you touch the spike on the vial adapter, germs from your fingers can be transferred.
Croatian: Ako dotaknete šiljak na nastavku za bočicu, može doći do prijenosa mikroorganizama s Vaših prstiju.
English: The reconstituted medicinal product should be inspected visually for particulate matter and discolouration prior to administration.
Croatian: Prije primjene treba vizualno pregledati rekonstituirani lijek kako bi se isključila prisutnost čestica i promjena boje.
English: The required dose is determined using the following formula: Required units (IU) = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL).
Croatian: a Potrebna doza određuje se prema sljedećoj formuli: Potreban broj jedinica (IU) = tjelesna težina (kg) x željeni porast faktora VIII (%) (IU/dl) x 0,5 (IU/kg po IU/dl).
English: If you notice particles or discolouration, do not use it. Use a new package instead.
Croatian: Ako primijetite čestice ili promjenu boje, nemojte koristiti otopinu.
English: AUCinf
Croatian: Osip
English: Posology
Croatian: Sadržaj
English: Until the threat is resolved a The required dose is determined using the following formula: Required units (IU) = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL).
Croatian: Do uklanjanja opasnosti a Potrebna doza određuje se prema sljedećoj formuli: Potreban broj jedinica (IU) = tjelesna težina (kg) x željeni porast faktora VIII (%) (IU/dl) x 0,5 (IU/kg po IU/dl).
English: • Turn over the protective cap, and snap the vial adapter onto the vial.
Croatian: • Preokrenite zaštitni omot i pričvrstite nastavak za bočicu na bočicu.
English: Syringe cap
Croatian: Zatvarač štrcaljke
English: To treat bleeding
Croatian: Za liječenje krvarenja
English: • Push the plunger rod to inject all the solvent into the vial.
Croatian: • Pritisnite potisnik klipa kako biste cjelokupno otapalo ubrizgali u bočicu.
English: Treatment with Esperoct will be started by a doctor who is experienced in the care of people with haemophilia A.
Croatian: Liječenje lijekom Esperoct započet će liječnik koji ima iskustva s liječenjem osoba s hemofilijom A. Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik.
English: • Remove the protective cap from the vial adapter.
Croatian: • Uklonite zaštitni papir s nastavka za bočicu.
English: Leave the plunger rod untouched in the carton.
Croatian: Potisnik klipa ostavite u kutiji.
English: Esperoct 1500
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Esperoct 1500
English: Table 3 Frequency of adverse reactions in clinical trials for PTPs* MedDRA System Organ Class
Croatian: Tablica 3 Učestalost nuspojava u kliničkim ispitivanjima za prethodno liječene bolesnike
English: Do not use the equipment if it has expired.
Croatian: Nemojte koristiti pribor ako mu je istekao rok valjanosti.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII pro-coagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Croatian: Ti su inhibitori obično IgG imunoglobulini koji djeluju protiv prokoagulacijske aktivnosti faktora VIII, a njihova se količina određuje u Bethesda jedinicama (engl.
English: Warnings and precautions Previous use of factor VIII medicine
Croatian: Upozorenja i mjere opreza
English: The expiry date is printed on the outer carton, on the vial, on the vial adapter, and on the pre-filled syringe.
Croatian: Rok valjanosti otisnut je na kutiji, bočici, nastavku za bočicu i napunjenoj štrcaljki.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA
English: Mild
Croatian: Blago
English: a The required dose is determined using the following formula: Required units (IU) = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL).
Croatian: Potreban broj jedinica (IU) = tjelesna težina (kg) x željeni porast faktora VIII (%) (IU/dl) x 0,5 (IU/kg po IU/dl).
English: After reconstitution, 1 mL of solution contains approximately 375 IU turoctocog alfa pegol.
Croatian: Nakon rekonstitucije, 1 ml otopine sadrži približno 375 IU turoktokog alfa pegola.
English: Stop the injection and contact your doctor or an emergency unit immediately if you have early signs of allergic reactions.
Croatian: Ako imate rane znakove alergijske reakcije, zaustavite injiciranje i odmah se obratite liječniku ili hitnoj medicinskoj službi.
English: • Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.
Croatian: • Pričvrstite napunjenu štrcaljku na nastavak za bočicu dok ne osjetite otpor.
English: Number of profiles
Croatian: 13. BROJ SERIJE
English: Guidance for the dosing of Esperoct for the on-demand treatment and treatment of bleeding episodes is provided in table 1.
Croatian: Tablica 1 Smjernice za liječenje epizoda krvarenja lijekom Esperoct Stupanj krvarenja
English: of patients
Croatian: FARMACEUTSKI
English: If you have to significantly increase your usage of Esperoct to stop a bleed, talk to your doctor immediately.
Croatian: Odmah se obratite liječniku ako morate značajno povećati primjenu lijeka Esperoct kako biste zaustavili krvarenje.
English: • Keep the plunger rod pushed completely in.
Croatian: • Držite potisnik klipa pritisnutim do kraja.
English: OTHER
Croatian: Eritem
English: Esperoct 3000 IU powder and solvent for solution for injection Each powder vial contains nominally 3000 IU turoctocog alfa pegol*.
Croatian: Esperoct 3000 IU prašak i otapalo za otopinu za injekciju Jedna bočica s praškom nominalno sadrži 3000 IU turoktokog alfa pegola*.
English: Disposal
Croatian: Doziranje
English: After reconstitution, 1 mL of solution contains approximately 125 IU turoctocog alfa pegol.
Croatian: Nakon rekonstitucije, 1 ml otopine sadrži približno 125 IU turoktokog alfa pegola.
English: • Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
Croatian: • Lagano povucite potisnik klipa prema dolje kako biste u štrcaljku uvukli otopinu pripremljenu za primjenu.
English: Esperoct 2000 IU powder and solvent for solution for injection Each powder vial contains nominally 2000 IU turoctocog alfa pegol*.
Croatian: Esperoct 2000 IU prašak i otapalo za otopinu za injekciju Jedna bočica s praškom nominalno sadrži 2000 IU turoktokog alfa pegola*.
English: Esperoct 500 IU powder and solvent for solution for injection Each powder vial contains nominally 500 IU turoctocog alfa pegol*.
Croatian: Esperoct 500 IU prašak i otapalo za otopinu za injekciju Jedna bočica s praškom nominalno sadrži 500 IU turoktokog alfa pegola*.
English: Esperoct 1500 IU powder and solvent for solution for injection Each powder vial contains nominally 1500 IU turoctocog alfa pegol*.
Croatian: Esperoct 1500 IU prašak i otapalo za otopinu za injekciju Jedna bočica s praškom nominalno sadrži 1500 IU turoktokog alfa pegola*.
English: After reconstitution, 1 mL of solution contains approximately 750 IU turoctocog alfa pegol.
Croatian: Nakon rekonstitucije, 1 ml otopine sadrži približno 750 IU turoktokog alfa pegola.
English: After reconstitution, 1 mL of solution contains approximately 500 IU turoctocog alfa pegol.
Croatian: Nakon rekonstitucije, 1 ml otopine sadrži približno 500 IU turoktokog alfa pegola.
English: After reconstitution, 1 mL of solution contains approximately 250 IU turoctocog alfa pegol.
Croatian: Nakon rekonstitucije, 1 ml otopine sadrži približno 250 IU turoktokog alfa pegola.
English: Esperoct 1000 IU powder and solvent for solution for injection Each powder vial contains nominally 1000 IU turoctocog alfa pegol*.
Croatian: Esperoct 1000 IU prašak i otapalo za otopinu za injekciju Jedna bočica s praškom nominalno sadrži 1000 IU turoktokog alfa pegola*.
English: These may become severe and could be life-threatening, see
Croatian: One mogu postati teške i po život opasne, za više informacija pogledajte „Alergijske reakcije (preosjetljivost)“
English: Pre-filled syringe with solvent Syringe tip (under syringe cap) Scale
Croatian: Vrh štrcaljke (ispod zatvarača štrcaljke) Skala
English: Esperoct 3000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Esperoct 3000
English: How Esperoct is given
Croatian: Kako se daje lijek Esperoct
English: Thread
Croatian: Pruritus
English: General disorders and administration sites conditions
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: Esperoct 3000 IU powder and solvent for solution for injection turoctocog alfa Pegol (recombinant coagulation factor VIII)
Croatian: Esperoct 3000 IU prašak i otapalo za otopinu za injekciju turoktokog alfa Pegol (rekombinantni koagulacijski faktor VIII)
English: Esperoct 1500 IU powder and solvent for solution for injection turoctocog alfa Pegol (recombinant coagulation factor VIII)
Croatian: Esperoct 1500 IU prašak i otapalo za otopinu za injekciju turoktokog alfa Pegol (rekombinantni koagulacijski faktor VIII)
English: Esperoct 500 IU powder and solvent for solution for injection turoctocog alfa Pegol (recombinant coagulation factor VIII)
Croatian: Esperoct 500 IU prašak i otapalo za otopinu za injekciju turoktokog alfa Pegol (rekombinantni koagulacijski faktor VIII)
English: Esperoct 2000 IU powder and solvent for solution for injection turoctocog alfa Pegol (recombinant coagulation factor VIII)
Croatian: Esperoct 2000 IU prašak i otapalo za otopinu za injekciju turoktokog alfa Pegol (rekombinantni koagulacijski faktor VIII)
English: Until the bleeding is resolved
Croatian: Do zaustavljanja krvarenja
English: Powder
Croatian: Prašak:
English: Esperoct 1000 IU powder and solvent for solution for injection turoctocog alfa Pegol (recombinant coagulation factor VIII)
Croatian: Esperoct 1000 IU prašak i otapalo za otopinu za injekciju turoktokog alfa Pegol (rekombinantni koagulacijski faktor VIII)
English: Esperoct 1000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Esperoct 1000
English: Reconstitute the powder with the solvent • Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Croatian: • Držite napunjenu štrcaljku lagano nagnutu, s bočicom prema dolje.
English: Contents
Croatian: Prikaz
English: Esperoct 2000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Esperoct 2000
English: Esperoct 2000 IU powder for solution for injection turoctocog alfa Pegol
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Esperoct 2000 IU prašak za otopinu za injekciju turoktokog alfa Pegol i.v.
English: EU/1/19/1374/001
Croatian: 12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1374/001
English: Esperoct 3000 IU powder for solution for injection turoctocog alfa Pegol
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Esperoct 3000 IU prašak za otopinu za injekciju turoktokog alfa Pegol i.v.
English: Esperoct 500 IU powder for solution for injection turoctocog alfa Pegol
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Esperoct 500 IU prašak za otopinu za injekciju turoktokog alfa Pegol i.v.
English: This summary was last updated in 01-2015.
Croatian: Sažetak je posljednji put ažuriran: 01.2015.
English: Raloxifene Teva EMA/805509/2014
Croatian: Raloksifen Teva EMA/805509/2014
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva lijeka su bioekvivalenti pod uvjetom da stvaraju iste razine djelatne tvari u organizmu.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Croatian: Cjelovito izvješće EPAR za referentni lijek također je dostupan na internetskim stranicama Agencije.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Raloxifene Teva.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Raloksifen Teva.
English: The European Commission granted a marketing authorisation valid throughout the EU for Raloxifene Teva on 29 April 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Raloksifen Teva vrijedi na prostoru Europske unije od 29. travnja 2010.
English: It is available as tablets (60 mg).
Croatian: Raloksifen Teva dostupan je u tabletama (60 mg).
English: Other information about Raloxifene Teva
Croatian: Ostale informacije o Raloksifen Teva
English: Raloxifene Teva is a ‘generic medicine'.
Croatian: Raloksifen Teva je "generički lijek".
English: This means that Raloxifene Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Evista.
Croatian: To znači da je Raloksifen Teva sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Evista.
English: The recommended dose of Raloxifene Teva is one tablet taken once a day.
Croatian: Preporučena doza lijeka Raloksifen Teva je jedna tableta na dan.
English: This is a summary of the European Public Assessment Report (EPAR) for Raloxifene Teva.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Raloksifen Teva.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
Croatian: Osteoporoza je učestalija u žena u postmenopauzi, kada se razine ženskog hormona smanjuju: estrogen usporava razgradnju kostiju i čini kosti podložnijima prijelomima.
English: Gradually, the bones become thin and fragile, and more likely to break (fracture).
Croatian: Postupno kosti postanu tanke i krhke te je izglednije da će doći do prijeloma.