FrancophonIA/ELRC3.0 huggingface dataset:
English: Only syringe needles (for example, non-metallic) with proven resistance to dilute acid should be used to minimise trace metal impurity levels.
Croatian: Kako bi se smanjila razina onečišćenja metalima u tragovima, treba koristiti samo igle za štrcaljke (primjerice nemetalne) koje su dokazano otporne na razrijeđenu kiselinu.
English: EXP {MM/YYYY} (12h CET)
Croatian: ROK VALJANOSTI Rok valjanosti {MM/GGGG} (12h CET)
English: Possible adverse reactions following the intravenous administration of a Yttrium (90Y)-labelled medicinal product prepared by radiolabelling with Yttriga, will be dependent on the specific medicinal product being used.
Croatian: Moguće nuspojave nakon intravenske primjena lijekova radioaktivno označenih itrijem (90Y) pomoću lijeka Yttriga ovisit će o korištenom specifičnom lijeku.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: 9.99 E-01 1.50 E+00 3.50 E+00 5.00 E+00 9.99 E+00 3.00 E+01 Urinary bladder 3.62 E-01 5.44 E-01 1.27 E+00 1.81 E+00 3.62 E+00 1.09 E+01 Uterus
Croatian: 9,99 E-01 1,50 E+00 3,50 E+00 5,00 E+00 9,99 E+00 3,00 E+01 Mokraćni mjehur 3,62 E-01 5,44 E-01 1,27 E+00 1,81 E+00 3,62 E+00 1,09 E+01 Maternica
English: The following preparations must be available in medical institutions, which use Yttriga for labelling of carrier molecules for therapeutic purposes: - Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or - Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
Croatian: - Ca-DTPA (trinatrij kalcij dietilen-triamin-pentaacetat) ili - Ca-EDTA (kalcij dinatrij etilen-diamin-tetraacetat)
English: NAME OF THE MEDICINAL PRODUCT Yttriga radiopharmaceutical precursor, solution.
Croatian: NAZIV GOTOVOG LIJEKA Yttriga radiofarmaceutski prekursor, otopina.
English: Information on radiation dosimetry of each different medicinal product following administration of the radiolabelled preparation will be available in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Croatian: Informacije o radijacijskoj dozimetriji svakog pojedinog lijeka nakon primjene radioaktivno označenog pripravka navedene su u Sažetku opisa svojstava lijeka/uputi priloženoj uz lijek koji se radioaktivno označava.
English: In the liver, 18 % of the injected activity is taken up 5 min after injection.
Croatian: Jetra apsorbira 18% primijenjene aktivnosti
English: For more information, refer to the package leaflet of the particular medicinal product to be radiolabelled.
Croatian: Za više informacija pogledajte uputu priloženu uz lijek koji će biti radioaktivno označen.
English: Such information will be supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Croatian: Takve su informacije navedene u Sažetku opisa svojstava lijeka/uputi priloženoj uz lijek koji se radioaktivno označava.
English: 4.7 Effects on ability to drive and use machines Effects on ability to drive and to use machines following treatment by Yttrium (90Y)-labelled medicinal products will be specified in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Croatian: Informacije o učincima na sposobnost upravljanja vozilima i strojevima nakon liječenja lijekovima radioaktivno označenima itrijem (90Y) navedene su u Sažetku opisa svojstava lijeka/uputi priloženoj uz lijek koji se radioaktivno označava.
English: Further information concerning the use of a Yttrium (90Y)-labelled medicinal products in pregnancy and breast-feeding is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.
Croatian: Daljnje informacije o korištenju lijekova radioaktivno označenih itrijem (90Y) tijekom trudnoće i dojenja navedene su u Sažetku opisu svojstava lijeka koji se radioaktivno označava.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Prije uzimanja bilo kakvog lijeka, posavjetujte se sa svojim liječnikom ili ljekarnikom.
English: Not applicable.
Croatian: PRIMJENU LIJEKA Nije primjenjivo.
English: The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Yttrium (90Y) to the radiation dose following the administration of Yttrium (90Y)-labelled medicinal product or resulting from an accidental intravenous injection of Yttriga.
Croatian: (90Y) radijacijskoj dozi nakon primjene lijeka označenog itrijem (90Y) ili kao rezultat nehotičnog intravenskog injiciranja lijeka Yttriga.
English: Each 10ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time.
Croatian: Svaka bočica od 10ml sadrži 0,1-300 GBq, ekvivalent 0,005-15 mikrograma itrija (90Y), na dan i sat umjeravanja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time (corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride).
Croatian: - 1 ml sterilne otopine sadrži 0,1-300 GBq itrija (90Y) na dan i sat umjeravanja (ekvivalent 0,00515 mikrograma itrija [90Y]) (u obliku itrijeva [90Y] klorida).
English: Each 3ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time.
Croatian: Svaka bočica od 3ml sadrži 0,1-300 GBq, ekvivalent 0,005-15 mikrograma itrija (90Y), na dan i sat umjeravanja.
English: Yttrium (90Y) chloride
Croatian: Yttriga radiofarmaceutski prekursor, otopina. itrijev (90Y) klorid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Yttrium (90Y) chloride
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI itrijev (90Y) klorid
English: For information concerning special warnings and special precautions for use of Yttrium (90Y)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Croatian: Za informacije o posebnim upozorenjima i posebnim mjerama predostrožnosti prilikom primjene lijekova radioaktivno označenih itrijem (90Y) pogledajte Sažetak opisa svojstava lijeka/uputu priloženu uz lijek koji se radioaktivno označava.
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: A PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: The pharmacodynamic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Croatian: Farmakodinamička svojstva lijekova označenih itrijem (90Y), pripremljenih radioaktivnim označavanjem pomoću lijeka Yttriga prije davanja pacijentu, ovise o prirodi lijeka koji se označava.
English: Further information concerning the use of a Yttrium (90Y)-labelled medicinal concerning fertility is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.
Croatian: Daljnje informacije o primjeni lijekova radioaktivno označenih itrijem (90Y) i utjecaja na plodnost navedene su u Sažetku opisu svojstava lijeka koji se radioaktivno označava.
English: Storage should be in accordance with national regulation on radioactive material.
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvanje treba biti u skladu s nacionalnim propisima za radioaktivni materijal.
English: For information on contraindications to particular Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga refer the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Croatian: Za informacije o kontraindikacijama za određeni lijek radioaktivno označen itrijem (90Y) pomoću lijeka Yttriga pogledajte Sažetak opisa svojstava lijeka/uputu priloženu uz lijek koji se radioaktivno označava.
English: For information concerning interactions associated with the use of Yttrium (90Y)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Croatian: Za informacije o interakcijama prilikom primjene lijekova radioaktivno označenih itrijem (90Y) pogledajte Sažetak opisa svojstava lijeka/uputu priloženu uz lijek koji se radioaktivno označava.
English: The toxicological properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Croatian: Toksična svojstva lijekova radioaktivno označenih itrijem (90Y) primjenom lijeka Yttriga prije davanja pacijentu ovise o prirodi lijeka koji se radioaktivno označava.
English: 7.90 E-02 1.18 E-01 2.76 E-01 3.95 E-01 7.90 E-01 2.37 E+00 Skeletal muscle 6.12 E-04 9.17 E-04 2.14 E-03 3.06 E-03 6.12 E-03 1.83 E-02 Skin
Croatian: 5,82 E-01 8,72 E-01 2,04 E+00 2,91 E+00 5,82 E+00 1,75 E+01 Debelo crijevo 2,30 E-02 3,46 E-02 8,06 E-02 1,15 E-01 2,30 E-01 6,91 E-01 Femur
English: België/Belgique/Belgien Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
Croatian: NOSITELJ ODOBRENJA Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Str. 10
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: LIMENKA I OLOVNI SPREMNIK
English: The pharmacokinetic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Croatian: 5.2 Farmakokinetička svojstva Farmakokinetička svojstva lijekova označenih itrijem (90Y) pripremljenih radioaktivnim označavanjem lijekom Yttriga prije davanja pacijentu ovise o prirodi lijeka koji se radioaktivno označava.
English: The radiation dose received by the various organs following intravenous administration of an Yttrium (90
Croatian: Doza zračenja koju primaju različiti organi nakon intravenske primjene lijeka označenog itrijem (90Y) ovisi o specifičnom lijeku koji se radioaktivno označava.
English: 6.6 Special precautions for disposal
Croatian: 6.2 Inkompatibilnosti
English: Pancreas
Croatian: Doza
English: (corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride).
Croatian: mikrograma itrija [90Y]) (u obliku itrijeva [90Y] klorida).
English: Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Croatian: Pogledajte Sažetak opisa svojstava lijeka/uputu priloženu uz lijek koji se radioaktivno označava.
English: 4.2 Posology and method of administration
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada na strojevima
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: EU/1/05/322/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/05/322/001
English: Yttriga.
Croatian: Gušterača
English: Pack size: 1 vial Not all presentations may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve vrste pakovanja.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Yttriga radiopharmaceutical precursor, solution.
Croatian: NAZIV GOTOVOG LIJEKA I PUT(EVI) PRIMJENE LIJEKA Yttriga radiofarmaceutski prekursor, otopina. itrijev (90Y) klorid
English: B. PACKAGE LEAFLET
Croatian: DODATAK III
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Croatian: Veličina pakovanja: 1 bočica
English: Κύπρος
Croatian: DODATAK
English: - 1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time
Croatian: 1 ml sterilne otopine sadrži 0,1-300 GBq itrija (90Y) na dan i sat umjeravanja (ekvivalent 0,005-15
English: 5 years.
Croatian: 5 godina
English: Date of first authorisation: 15 January 2015
Croatian: Datum prvog odobrenja: 15. siječnja 2015.
English: You should therefore speak to your doctor immediately.
Croatian: Morate se odmah obratiti svom liječniku.
English: AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, FR, HR, HU, IE, IS, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK
Croatian: AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, FR, HR, HU, IE, IS, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK Shionogi B.V.
English: The apparent volume of distribution is 448 l.
Croatian: Prividni volumen distribucije iznosi 448 l.
English: Elderly (>65 years old)
Croatian: Starije bolesnice (>65 godina)
English: Do not give this medicine to children or adolescents.
Croatian: Ovaj lijek nemojte davati djeci ili adolescentima.
English: The magnitude of effect was similar in all three trials.
Croatian: Opseg ovog učinka bio je sličan u sva tri ispitivanja.
English: PVC/PVdC-Aluminium blister.
Croatian: PVC/PVdC-aluminij blister.
English: Do not take two tablets in one day to make up for a forgotten tablet.
Croatian: Nemojte uzeti dvije tablete u jednom danu kako biste nadoknadili zaboravljenu tabletu.
English: Risk management plan (RMP)
Croatian: • Plan upravljanja rizikom (RMP)
English: The potential risk in humans is unknown.
Croatian: Mogući rizik za ljude nije poznat.
English: A double dose should not be taken in the same day.
Croatian: Dvostruka se doza ne smije uzeti istog dana.
English: However, all exposures were far below the intended human exposure.
Croatian: Međutim, sve te izloženosti bile su daleko ispod namjeravane izloženosti u ljudi.
English: The most frequently reported adverse reactions are hot flushes (7.5%).
Croatian: Najčešće prijavljene nuspojave su navale vrućine (7,5%).
English: This happens naturally after menopause (post-menopause).
Croatian: To se prirodno događa nakon menopauze (u postmenopauzi).
English: Your doctor will explain the effects of stopping treatment and will also discuss other possibilities for treatment with you.
Croatian: Vaš će Vam liječnik objasniti učinke prekida liječenja i razgovarati s Vama o drugim mogućnostima liječenja.
English: Do not take Senshio with any of these medicines:
Croatian: Nemojte uzimati Senshio niti s jednim od ovih lijekova:
English: Physiological responses (objective measures)
Croatian: Fiziološki odgovori (objektivna mjerenja)
English: The tablets should be swallowed whole with food.
Croatian: Tabletu treba progutati cijelu s hranom.
English: Kingsfordweg 151 1043GR Amsterdam Netherlands
Croatian: Kingsfordweg 151 1043GR Amsterdam Nizozemska
English: This medicine is not recommended if you have severely reduced liver function.
Croatian: Ovaj se lijek ne preporučuje ako imate teško smanjenu funkcije jetre.
English: In the F0 maternal generation, a significant prolonged gestation was observed.
Croatian: U majki F0 generacije primijećeno je značajno produženje gestacije.
English: Once you have started on Senshio you should see your doctor for regular check-ups (at least once a year).
Croatian: Kad jednom započnete uzimati Senshio morate odlaziti liječniku na redovite kontrole (najmanje jedanput godišnje).
English: Unexplained vaginal bleeding.
Croatian: Neobjašnjivo vaginalno krvarenje.
English: Symptoms (subjective measures)
Croatian: Simptomi (subjektivna mjerenja)
English: The relative contribution of the metabolite to the pharmacological effect is estimated to be approximately 40%.
Croatian: Relativni doprinos metebolita farmakološkom učinku lijeka procijenjuje se na oko 40%.
English: It is caused by a lowering in the levels of the female hormone oestrogen in your body.
Croatian: Uzrokovano je sniženjem razine ženskog hormona estrogena u Vašem tijelu.
English: Treatment should be resumed only after the patient is mobilised.
Croatian: Liječenje je potrebno nastaviti tek nakon što se bolesnik mobilizira.
English: Pharmacokinetics in subpopulations
Croatian: Farmakokinetika u subpopulacijama
English: It is recommended that any additional pathology be investigated and treated appropriately before starting ospemifene.
Croatian: Preporučuje se da se svako dodatno patološko stanje ispita i odgovarajuće liječi prije početka terapije ospemifenom.
English: There were no discernible differences in ospemifene plasma concentrations among these groups; however, the influence of race cannot be conclusively determined.
Croatian: Nije bilo zamjetnih razlika u koncentracijama ospemifena u plazmi između ovih skupina; ipak, utjecaj rase ne može se jasno utvrditi.
English: Senshio must be taken every day for as long as your doctor tells you to.
Croatian: Senshio se mora uzimati svaki dan onoliko dugo koliko to odredi Vaš liječnik.
English: If a dose is missed it should be taken with food as soon as the patient remembers.
Croatian: Ako se doza propusti, potrebno ju je uzeti s hranom čim se bolesnica sjeti.
English: “Improvement” was defined as a reduction in the severity score of 1 or more.
Croatian: „Poboljšanje“ je definirano kao smanjenje rezultata bodovanja težine simptoma za 1 ili više bodova.
English: There is no specific antidote for ospemifene.
Croatian: Nema specifičnog antidota za ospemifen.
English: Ospemifene should only be continued as long as the benefit outweighs the risk.
Croatian: Liječenje ospemifenom potrebno je nastaviti samo dok korist od njegove primjene premašuje rizik.
English: Other medicines and Senshio
Croatian: Drugi lijekovi i Senshio
English: Patients with liver disease
Croatian: Bolesnici s bolešću jetre
English: About 1% of subjects discontinued in the Phase 2/3 clinical programme due to hot flushes.
Croatian: Oko 1% ispitanica prekinulo je sudjelovanje tijekom faze 2/3 kliničkog programa zbog navala vrućine.
English: The risk of VTE is temporarily increased with prolonged immobilisation, major trauma or major surgery.
Croatian: Rizik za VTE privremeno je povećan kod produžene imobilizacije, velike traume ili velikog kirurškog zahvata.
English: Patients with signs or symptoms of endometrial hyperplasia; safety in this patient group has not been studied.
Croatian: Bolesnice sa znakovima ili simptomima hiperplazije endometrija; sigurnost primjene u ovoj skupini bolesnica nije ispitana.
English: If you forget to take a tablet you should take the missed tablet (with food) as soon as you remember within the same day.
Croatian: Ako ste zaboravili uzeti tabletu, uzmite propuštenu tabletu (s hranom) čim se sjetite istog dana.
English: At these check-ups, discuss with your doctor the benefits and risks of continuing with Senshio.
Croatian: Prilikom tih kontrola raspravite sa svojim liječnikom o koristima i rizicima nastavka primjene lijeka Senshio.
English: Tell your doctor immediately if you become pregnant while taking Senshio; treatment should be stopped immediately.
Croatian: Odmah se obratite svom liječniku ako zatrudnite dok uzimate Senshio; liječenje se mora smjesta prekinuti.
English: No data are available on its concomitant use with medicinal products used in the treatment of early or advanced breast cancer.
Croatian: Nema dostupnih podataka o njegovoj istodobnoj primjeni s lijekovima koji se koriste u liječenju ranog ili uznapredovalog raka dojke.
English: What Senshio is and what it is used for
Croatian: Što je Senshio i za što se koristi
English: Manufacturing Packaging Farmaca (MPF) B.V. Appelhof 13
Croatian: Manufacturing Packaging Farmaca (MPF) B.V.
English: Your doctor may recommend that you stop treatment at least 4 to 6 weeks prior to major surgery or during a long period of bed rest e.g. injury or illness.
Croatian: Liječnik Vam može preporučiti prekid liječenja najmanje 4 do 6 tjedana prije velikog kirurškog zahvata ili tijekom duljeg razdoblja mirovanja u krevetu, npr. zbog ozljede ili bolesti.
English: Shionogi B.V. Tel/Tel./Te./Tlf/Tél/Puh/Sími/ :
Croatian: Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ:
English: It must not be taken by women who are pregnant, who could still have a baby or are breast-feeding.
Croatian: Ne smiju ga uzimati trudnice, žene koje još uvijek mogu zatrudnjeti ili koje doje.
English: Ospemifene (OSP) improved post-menopausal physiologic changes.
Croatian: Ospemifen (OSP) je poboljšao fiziološke promjene uzrokovane menopauzom.
English: Your doctor may consider stopping treatment with Senshio while you are taking fluconazole.
Croatian: Vaš liječnik može razmotriti prekid liječenja lijekom Senshio dok uzimate flukonazol.
English: In the event of overdose, general supportive measures should be initiated based on the patient's signs and symptoms.
Croatian: U slučaju predoziranja potrebno je započeti s općim suportivnim mjerama na temelju postojećih znakova i simptoma kod bolesnice.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, selective estrogen receptor modulators, ATC code: G03XC05.
Croatian: Farmakoterapijska skupina: spolni hormoni i modulatori genitalnog sustava, selektivni modulatori estrogenskih receptora, ATK oznaka: G03XC05.
English: The apparent total body clearance is 9.16 l/hr using a population approach.
Croatian: Prividni ukupni klirens iz tijela iznosi 9,16 l/h, koristeći se populacijskim pristupom.
English: The fate of remaining fraction is unknown but can probably be explained by formation of glucuronide metabolites.
Croatian: Nije poznato što se događa s preostalim dijelom, ali se vjerojatno može objasniti stvaranjem metabolita glukuronida.
English: This binding results in activation of some oestrogenic pathways (agonism) and blockade of other oestrogenic pathways (antagonism).
Croatian: Posljedica ovog vezivanja je aktivacija nekih estrogenskih puteva (agonizam) i blokada drugih estrogenskih puteva (antagonizam).
English: - If you have excessive thickening of the womb lining such as endometrial hyperplasia.
Croatian: - ako imate prekomjerno zadebljanje sluznice maternice, poput hiperplazije endometrija.
English: Cerebro-vascular events
Croatian: Cerebrovaskularni događaji
English: In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually taking into consideration other menopausal symptoms, effects on uterine and breast tissues, thromboembolic and cerebrovascular risks.
Croatian: U svim slučajevima potrebno je pažljivo procijeniti rizike i koristi od liječenja najmanje jedanput godišnje uzimajući pritom u obzir druge simptome menopauze, učinke na tkivo maternice i dojki, rizike od tromboembolije i cerebrovaskularnih događaja.
English: What Senshio is and what it is used for What you need to know before you take Senshio How to take Senshio
Croatian: Što je Senshio i za što se koristi Što morate znati prije nego počnete uzimati Senshio Kako uzimati Senshio
English: Improvement
Croatian: Poboljšanje
English: Fluconazole (an oral medicine used to treat fungal infections) as this may increase the amount of ospemifene in your blood.
Croatian: • flukonazolom (lijek koji se uzima kroz usta za liječenje gljivičnih infekcija) jer može povisiti količinu ospemifena u Vašoj krvi.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ospemifene in all subsets of the paediatric population in VVA (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja ospemifena u svim podskupinama pedijatrijske populacije u indikaciji VVA (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Due to its lipophilic nature and absorption characteristics, an interaction between ospemifene and medicinal products like orlistat, cannot be ruled out.
Croatian: Zbog njegove lipofilne prirode i karakteristika apsorpcije, interakcija ospemifena s lijekovima poput orlistata, ne može se isključiti.
English: If VTE develops after initiating therapy, the treatment should be discontinued.
Croatian: Nastupi li VTE nakon započinjanja terapije, liječenje se mora prekinuti.
English: In some asymptomatic patients, hot flushes may occur upon beginning therapy.
Croatian: U nekih asimptomatskih bolesnica navale vrućine mogu se pojaviti nakon započinjanja terapije.
English: When this happens, the vaginal walls can become thinner.
Croatian: Kad se to dogodi, stijenke rodnice postaju tanje.
English: You will not benefit from the effects of Senshio if you stop using it without talking to your doctor.
Croatian: Nećete imati koristi od učinaka lijeka Senshio ako ga prestanete uzimati bez da ste se posavjetovali s liječnikom.