FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: However, no clinically relevant effects on ECG have been observed in clinical studies with SANCUSO, including a through QT study in 240 healthy subjects (section 5.1).
Croatian: Međutim, u kliničkim ispitivanjima s lijekom SANCUSO, uključujući temeljito ispitivanje QT intervala na 240 zdravih ispitanika, nisu zapaženi klinički značajni učinci na EKG (dio 5.1).
English: The transdermal patch should be applied to clean, dry, intact healthy skin on the outer part of the upper arm.
Croatian: Transdermalni flaster treba zalijepiti na čistu, suhu, neoštećenu zdravu kožu na vanjskoj strani nadlaktice.
English: Backing layer Polyester
Croatian: Vanjski potporni sloj poliester
English: After removing the transdermal patch
Croatian: Nakon uklanjanja transdermalnog flastera
English: Each carton contains one transdermal patch.
Croatian: Svaka kutija sadrži jedan transdermalni flaster.
English: Paediatric population No studies have been performed to investigate the pharmacokinetics of SANCUSO in paediatrics.
Croatian: Pedijatrijska populacija Nisu provedena ispitivanja farmakokinetike lijeka SANCUSO u pedijatrijskih bolesnika.
English: The signs may include red, raised itchy bumps
Croatian: Simptomi mogu uključivati crvene, izdignute izbočine koje svrbe.
English: Application site irritation Application site reactions (application site pain, application site pruritus, application site erythema, application site rash, application site irritation) *
Croatian: Reakcije na mjestu primjene (bol na mjestu primjene, svrbež na mjestu primjene, eritem na mjestu primjene, osip na mjestu primjene i iritacija na mjestu primjene) *
English: How to use SANCUSO
Croatian: Kako primjenjivati SANCUSO
English: Concurrent administration of a single intravenous bolus of 0.01 mg/kg (maximum 1 mg) granisetron at the same time a SANCUSO transdermal patch was applied was investigated in healthy subjects.
Croatian: Na zdravim ispitanicima ispitana je istovremena primjena jednog intravenskog bolusa od 0,01 mg/kg granizetrona (najviše 1 mg) i transdermalnog flastera SANCUSO.
English: Patients must be advised to cover the transdermal patch application site, e.g. with clothing, if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal.
Croatian: Potrebno je savjetovati bolesnike da pokriju mjesto primjene transdermalnog flastera, npr. odjećom, cijelo vrijeme tijekom nošenja flastera i još 10 dana nakon njegovog uklanjanja ako postoji opasnost od izlaganja sunčevoj svjetlosti.
English: Each carton contains 1 transdermal patch.
Croatian: Svaka kutija sadrži 1 transdermalni flaster.
English: If reattachment is not possible or the transdermal patch is damaged, a new transdermal patch should be applied in the same position as the original transdermal patch.
Croatian: Ako se flaster ne može ponovno zalijepiti ili je oštećen, potrebno je na isto mjesto zalijepiti novi transdermalni flaster.
English: No clinical studies have been performed specifically to investigate the pharmacokinetics of SANCUSO in patients with renal or hepatic impairment.
Croatian: Nisu provedena posebna klinička ispitivanja farmakokinetike lijeka SANCUSO u bolesnika s oštećenjem funkcije bubrega ili jetre.
English: The transdermal patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen.
Croatian: Transdermalni flaster može se nositi do 7 dana ovisno o trajanju kemoterapijskog protokola.
English: As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration.
Croatian: Granizetron može smanjiti motilitet donjeg dijela crijeva pa je zbog toga nakon primjene potrebno pratiti bolesnike sa znakovima subakutne opstrukcije crijeva.
English: If you are being treated with chemotherapy that is moderately or highly capable of making you feel sick, you may still be sick despite treatment with anti-sickness medicine, including this medicine.
Croatian: Ako primate kemoterapiju koja može izazvati umjerenu ili izrazitu mučninu, može se javiti povraćanje unatoč primjeni lijekova protiv mučnine i povraćanja, uključujući ovaj lijek.
English: Due to a gradual increase in plasma levels of granisetron following application of the transdermal patch, a slower onset of efficacy compared to 2 mg oral granisetron may be observed at the start of chemotherapy; the patch should be applied 24-48 hours before chemotherapy.
Croatian: Zbog postupnog povećanja koncentracije granizetrona u plazmi nakon primjene transdermalnog flastera, djelovanje započinje kasnije nego pri peroralnoj primjeni 2 mg granizetrona pa je flaster potrebno primijeniti 24-48 sati prije kemoterapije.
English: The transdermal patch should not be cut into pieces.
Croatian: Transdermalni flaster ne smije se rezati.
English: What you need to know before you use SANCUSO Do not use SANCUSO:
Croatian: Što morate znati prije nego počnete primjenjivati SANCUSO
English: Adverse reactions reported for SANCUSO System Organ Class
Croatian: Nuspojave prijavljene pri primjeni lijeka SANCUSO
English: How to store SANCUSO
Croatian: Kako čuvati SANCUSO
English: You can continue to shower and wash normally while wearing the transdermal patch.
Croatian: Kada nosite transdermalni flaster možete se nastaviti normalno tuširati i prati.
English: Remove the transdermal patch at least 1 day (24 hours) after completing your chemotherapy.
Croatian: Uklonite transdermalni flaster najranije 1 dan (24 sata) nakon završetka kemoterapije.
English: Anti-emetic activity was assessed from the first administration until 24 hours after the start of the last day's administration of the ME or HE chemotherapy regimen.
Croatian: Antiemetski učinak procjenjivan je od prve primjene do 24 sata nakon zadnjeg dana primjene umjereno ili izrazito emetogene kemoterapije.
English: Although no evidence of an increased incidence of adverse reactions have been observed in patients with renal or hepatic impairment receiving granisetron orally and intravenously, based on granisetron pharmacokinetics, a degree of caution must be exercised in this population.
Croatian: Iako u bolesnika s oštećenjem funkcije bubrega ili jetre, koji su peroralno i intravenski primali granizetron, nije uočen porast incidencije nuspojava, na temelju podataka o farmakokinetici granizetrona, nužan je oprez u ovoj populaciji bolesnika.
English: Apply a transdermal patch at least 1 day (24 hours) before you are scheduled to have chemotherapy treatment.
Croatian: Primijenite transdermalni flaster najmanje 1 dan (24 sata) prije planirane kemoterapije.
English: Package Leaflet: Information for the patient SANCUSO 3.1 mg/24 hours transdermal patch
Croatian: Uputa o lijeku: Informacije za bolesnika SANCUSO 3,1 mg/24 sata transdermalni flaster granizetron
English: Rare side effects (may affect up to 1 in 1,000 people) are: - abnormal muscle movements (such as shaking, muscle rigidity and muscle contractions).
Croatian: - neuobičajeni pokreti mišića (kao što su drhtanje, ukočenost mišića i grčenje mišića).
English: Where to apply the transdermal patch
Croatian: Gdje primijeniti transdermalni flaster
English: Consequently, SANCUSO is indicated for use in patients where oral anti-emetic administration is complicated by factors making swallowing difficult.
Croatian: Zato je transdermalni flaster SANCUSO indiciran za primjenu u bolesnika kod kojih je peroralna primjena antiemetika komplicirana zbog otežanog gutanja.
English: How to apply the transdermal patch
Croatian: Kako primijeniti transdermalni flaster
English: Each 52 cm2 transdermal patch contains 34.3 mg of granisetron, releasing 3.1 mg of granisetron in 24 hours.
Croatian: Jedan transdermalni flaster površine 52 cm2 sadrži 34,3 mg granizetrona i oslobađa 3,1 mg granizetrona u 24 sata.
English: 1 transdermal patch
Croatian: 1 transdermalni flaster
English: - You should avoid external heat (for example hot water bottles or heat pads) on the area of the transdermal patch.
Croatian: - Trebate izbjegavati primjenu vanjskih izvora topline (na primjer vruće termofore ili grijaće jastuke) u predjelu nošenja transdermalnog flastera.
English: Common Dry mouth, nausea, retching Uncommon
Croatian: Suha usta, mučnina, dizanje želuca
English: Class effects Class effects for granisetron seen with other formulations (oral and intravenous) include the following:
Croatian: Učinci skupine lijekova Učinci skupine za granizetron uočeni kod drugih oblika primjene (peroralnog i intravenskog)
English: This medicine is for transdermal use.
Croatian: Lijek se izdaje na recept.
English: This medicine delivers the active substance slowly and constantly through your skin and into your blood stream for the duration that you are wearing the transdermal patch.
Croatian: Cijelo vrijeme dok nosite transdermalni flaster, djelatna tvar sporo i neprekidno prolazi kroz Vašu kožu i ulazi u krvotok.
English: Each sachet contains one transdermal patch stuck onto a rigid plastic film.
Croatian: Jedna vrećica sadrži jedan transdermalni flaster, prilijepljen na čvrstu plastičnu podlogu.
English: Keep the transdermal patch in place for the whole time you are having chemotherapy.
Croatian: Ostavite transdermalni flaster prilijepljen tijekom cijelog trajanja kemoterapije.
English: External heat (for example hot water bottles or heat pads) should be avoided on the area of the transdermal patch.
Croatian: Potrebno je izbjegavati primjenu vanjskih izvora topline (na primjer vruće termofore ili grijaće jastuke) u predjelu gdje je zalijepljen transdermalni flaster.
English: An initial peak in plasma concentrations of granisetron, attributable to the intravenous dose, was reached at 10 minutes post-administration.
Croatian: Deset minuta nakon primjene dostignute su početne vršne koncentracije granizetrona u plazmi, što se može pripisati intravenskoj dozi.
English: No clear relationship between renal function (as measured by creatinine clearance) and granisetron clearance was identified in population PK modelling.
Croatian: Kod modeliranja populacijske farmakokinetike nisu utvrđene jasne poveznice između funkcije bubrega (mjerene klirensom kreatinina) i klirensa granizetrona.
English: Fertility was unaffected following granisetron treatment in rats.
Croatian: Granizetron nije imao nikakvih učinaka na plodnost štakora.
English: Gently wash the area with soap and water to remove it. Alcohol or other dissolving liquids such as nail polish remover may cause skin irritation and should not be used.
Croatian: Nemojte upotrebljavati alkohol ili druga otapala poput odstranjivača laka za nokte jer mogu nadražiti kožu.
English: Adverse reactions are presented in order of decreasing seriousness within each frequency grouping.
Croatian: Unutar svake skupine učestalosti, nuspojave su navedene od najozbiljnije prema manje ozbiljnima.
English: SANCUSO 3.1 mg/24 hours transdermal patch
Croatian: SANCUSO 3,1 mg/24 sata transdermalni flaster
English: External heat, for example from hot water bottles or heat pads, should be avoided on the area of the transdermal patch.
Croatian: Potrebno je izbjegavati primjenu vanjskih izvora topline, na primjer vruće termofore ili grijaće jastuke, u predjelu nošenja transdermalnog flastera.
English: Granisetron
Croatian: Nuspojava
English: The transdermal patch will still contain active substance following use.
Croatian: Transdermalni flaster i nakon primjene sadrži djelatnu tvar.
English: - Allergic reactions including urticaria (itchy, red, raised skin rash) and anaphalaxis (a serious allergic reaction which may include sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching) - Difficulty sleeping/disturbed sleep - Excessive sleepiness - Prolonged QT interval in the ECG (changes to the heart rate trace (ECG) indicating a heart rhythm disorder) - Constipation - Diarrhoea - Lack of energy/weakness /Loss of strength
Croatian: i anafilaksija (ozbiljna alergijska reakcija koja može uključivati iznenadno zviždanje u plućima pri disanju, otežano disanje, oticanje kapaka, lica ili usana, osip ili svrbež)
English: SANCUSO 3.1 mg/24 h transdermal patch Granisetron Transdermal use
Croatian: SANCUSO 3,1 mg/24 h transdermalni flaster granizetron
English: SANCUSO transdermal patches did not show any potential for photoirritation or photosensitivity when tested in vivo in guinea-pigs.
Croatian: Kod in vivo ispitivanja na zamorcima, transdermalni flasteri SANCUSO nisu pokazali potencijal za fotoiritaciju ili fotosenzibilnost.
English: No clinically relevant effects have been observed in clinical studies with SANCUSO.
Croatian: U kliničkim ispitivanjima lijeka SANCUSO nisu uočeni klinički značajni učinci.
English: SANCUSO 3.1 mg/24 hours transdermal patch Granisetron
Croatian: SANCUSO 3,1 mg/24 sata transdermalni flaster granizetron
English: No dose adjustments are necessary for the elderly or patients with renal or hepatic impairment.
Croatian: U starijih bolesnika i u bolesnika s oštećenjem funkcije bubrega ili jetre prilagođavanje doze nije potrebno.
English: - SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
Croatian: Obavezno obavijestite svog liječnika ili medicinsku sestru ako uzimate sljedeće lijekove: - paracetamol, koji se koristi za ublažavanje boli, - fenobarbital, koji se koristi za liječenje epilepsije, - ketokonazol, koji se koristi za liječenje gljivičnih infekcija, - SSRI (selektivni inhibitori ponovne pohrane serotonina), koji se koriste za liječenje depresije i/ili tjeskobe, uključujući fluoksetin, paroksetin, sertralin, fluvoksamin, citalopram,
English: Constipation
Croatian: Vrtoglavica
English: Adults (≥18 years)
Croatian: Odrasli (≥ 18 godina)
English: • improve your physical function.
Croatian: • poboljšala Vaša fizička funkcionalnost.
English: EXP EXP, if not refrigerated _________________________
Croatian: EXP EXP, ako se ne čuva u hladnjaku_________
English: The reconstituted solution should stand for 5 minutes.
Croatian: Rekonstituirana otopina treba odstajati 5 minuta.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: Prolonged or vigorous agitation must be avoided.
Croatian: Dugotrajno ili žustro mućkanje mora se izbjegavati.
English: Patients with no deterioration/patients evaluated (%)
Croatian: Bolesnici bez pogoršanja/evaluirani bolesnici (%)
English: Before reconstitution
Croatian: Prije rekonstitucije
English: • Orencia (which contains abatacept).
Croatian: • lijek Orencia (koji sadrži abatacept).
English: Reconstitute and dilute before use.
Croatian: Rekonstituirati i razrijediti prije uporabe.
English: In addition, bone fracture (6.8%) was reported, however, a causal association has not been established.
Croatian: Osim toga prijavljeni su lomovi kostiju (6,8%), ali nije ustanovljena uzročna veza.
English: 23 Academy-ro, Yeonsu-gu, Incheon, 22014 Republic of Korea
Croatian: 23 Academy-ro, Yeonsu-gu, Incheon, 22014 Republika Koreja
English: Date of first authorisation: 10 September 2013 Date of latest renewal: 21 June 2018
Croatian: Datum posljednje obnove odobrenja: 21. lipanj 2018.
English: Inflectra is indicated for:
Croatian: Inflectra je indicirana za:
English: • Severe allergic reaction that may cause loss of consciousness and could be life-threatening
Croatian: • ozbiljna alergijska reakcija koja uzrokuju gubitak svijesti i može biti opasna po život
English: The patient reminder card shall contain the following key messages:
Croatian: Kartica s podsjetnikom za bolesnika će sadržavati sljedeće ključne poruke:
English: • Your doctor or nurse will prepare the medicine for infusion.
Croatian: • Vaš liječnik ili medicinska sestra će pripremiti lijek za infuziju.
English: What Inflectra is and what it is used for
Croatian: Što je Inflectra i za što se koristi
English: • you are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6),
Croatian: • ako ste alergični na infliksimab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.),
English: Inflectra is also used in adults and children 6 years of age or older for:
Croatian: Inflectra se također koristi u odraslih i djece u dobi od 6 ili više godina za liječenje:
English: Some of these reactions may be serious or life-threatening.
Croatian: Neke od tih reakcija mogu biti ozbiljne ili ugroziti život bolesnika.
English: Pack sizes of 1, 2, 3, 4, 5 vials.
Croatian: Veličine pakiranja od 1, 2, 3, 4, 5 bočica.
English: • Kineret (which contains anakinra).
Croatian: • lijek Kineret (koji sadrži anakinru).
English: Inflectra belongs to a group of medicines called ‘TNF blockers'.
Croatian: Inflectra pripada skupini lijekova koji se nazivaju "TNF-blokatorima".
English: If you forget or miss your Inflectra infusion
Croatian: Ako ste zaboravili ili propustili infuziju lijeka Inflectra
English: placebo inflixim ab placebo inflixim ab placebo inflixim ab placebo inflixim ab
Croatian: placebo infliksimab placebo infliksimab placebo infliksimab placebo infliksimab
English: Children and adolescents The information above also applies to children and adolescents.
Croatian: Gore navedene informacije odnose se i na djecu i adolescente.
English: • reduce the signs and symptoms of your disease,
Croatian: • umanjili znakovi i simptomi bolesti
English: Results from week 54 are shown in Table 4.
Croatian: Rezultati nakon 54 tjedana prikazani su u Tablici 4.
English: Three cases of pneumonia (1 serious) and 2 cases of herpes zoster (both non-serious) were reported.
Croatian: Prijavljena su i 3 slučaja pneumonije (1 ozbiljan) i 2 slučaja herpesa zostera (niti jedan ozbiljan).
English: Inflectra should only be used during pregnancy if your doctor feels it is necessary for you.
Croatian: Inflectra se tijekom trudnoće smije primjenjivati samo ako Vaš liječnik smatra da je to neophodno za Vas.
English: Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
Croatian: Inflectra je u kombinaciji s metotreksatom indicirana za smanjivanje znakova i simptoma te poboljšavanje fizičkih funkcija u:
English: • Blood test result showing ‘antibodies' against your own body.
Croatian: • nalazi pretraga krvi koji pokazuju „protutijela“ koja se bore protiv Vašeg tijela.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: • Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: If there are any changes in your skin or growths on the skin during or after therapy, tell your doctor.
Croatian: Ako se tijekom ili nakon liječenja pojave promjene na koži ili izrasline na koži, obavijestite o tome svog liječnika.
English: • Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „EXP“.
English: Your doctor will advise you what other medicines you must keep using while you are having Inflectra.
Croatian: Liječnik će Vam savjetovati koje lijekove morate nastaviti uzimati dok primate lijek Inflectra.
English: The potential risk with the combination of AZA or 6-MP and infliximab should be carefully considered.
Croatian: Treba pomno razmotriti potencijalni rizik primjene kombinacije AZA odnosno 6-MP i infliksimaba.
English: Other medicines and Inflectra
Croatian: Drugi lijekovi i Inflectra
English: The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Croatian: Relativni nedostatak TNFα prouzročen anti-TNF terapijom može pokrenuti autoimuni proces.
English: THE VIAL MUST NOT BE SHAKEN.
Croatian: BOČICA SE NE SMIJE TRESTI.
English: Granulomatous lesion.
Croatian: granulomatozna lezija
English: Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after infliximab treatment.
Croatian: Budući da se humani imunoglobulini izlučuju u majčino mlijeko, žene ne smiju dojiti najmanje 6 mjeseci nakon liječenja infliksimabom.
English: For women taking Inflectra including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Croatian: Ženama koje uzimaju lijek Inflectra, uključujući i one starije od 60 godina, liječnik može preporučiti redovite preglede za prevenciju raka grlića maternice.
English: EU/1/13/854/001 1 vial EU/1/13/854/002 2 vials EU/1/13/854/003 3 vials EU/1/13/854/004 4 vials EU/1/13/854/005 5 vials
Croatian: EU/1/13/854/001 1 bočica EU/1/13/854/002 2 bočice EU/1/13/854/003 3 bočice EU/1/13/854/004 4 bočice EU/1/13/854/005 5 bočica
English: For volumes greater than 250 mL, either use a larger infusion bag (e.g. 500 mL, 1000 mL) or use multiple 250 mL infusion bags to ensure that the concentration of the infusion solution does not exceed 4 mg/mL.
Croatian: Za volumene veće od 250 ml upotrijebite ili jednu veću infuzijsku vrećicu (npr. od 500 ml, 1000 ml) ili nekoliko infuzijskih vrećica od 250 ml kako biste bili sigurni da koncentracija otopine za infuziju neće biti veća od 4 mg/ml.
English: Inflectra must be given concomitantly with methotrexate.
Croatian: Inflectra se mora davati istodobno s metotreksatom.
English: There are insufficient preclinical data to draw conclusions on the effects of infliximab on fertility and general reproductive function (see section 5.3).
Croatian: Nema dovoljno nekliničkih podataka da bi se donio zaključak o utjecaju infliksimaba na plodnost i opću reproduktivnu funkciju (vidjeti dio 5.3).
English: • It is recommended that when Inflectra is prepared for infusion, it is used as soon as possible (within 3 hours).
Croatian: • Preporučuje se pripremljenu otopinu za infuziju lijeka Inflectra upotrijebiti što prije (u roku od 3 sata).
English: Storage beyond 24 hours at 2 °C - 8 °C applies to preparation of Inflectra in the infusion bag only.
Croatian: Čuvanje dulje od 24 sata na temperaturi od 2°C do 8°C se odnosi samo na pripremu lijeka Inflectra u infuzijskoj vrećici.
English: In this trial, sixty-six percent of the patients (686 out of 1,040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1,040) received at least one shortened infusion of 60 minutes or less.
Croatian: U ovom je ispitivanju 66% bolesnika (686 od 1040) primilo barem jednu infuziju u skraćenom trajanju od 90 minuta ili manje, a 44% bolesnika (454 od 1040) barem jednu infuziju u skraćenom trajanju od 60 minuta ili manje.
English: The flip-top from the vial has to be removed and the top has to be wiped with a 70% alcohol swab.
Croatian: Morate skinuti poklopac s bočice i obrisati vrh vatom natopljenom 70%-tnim alkoholom.
English: Single intravenous infusions of 1, 3, 5, 10 or 20 mg/kg of infliximab yielded dose proportional increases in the maximum serum concentration (Cmax) and area under the concentration-time curve (AUC).
Croatian: Jednokratne intravenske infuzije od 1, 3, 5, 10 ili 20 mg/kg infliksimaba rezultirala su povećanjima proporcionalna dozi maksimalne koncentracije u serumu (Cmax) i površine ispod krivulje koncentracija-vrijeme (AUC).
English: Overall proportions of adverse events and infusion reactions were similar between the 6 to 11 and 12 to 17 year age groups.
Croatian: Ukupni udjeli štetnih događaja i reakcija na infuziju bili su slični u dobnoj skupini od 6 do11 godina i onoj od 12 do17 godina.
English: Patients who did not respond to infliximab at week 8 (n=15) received no further medicinal product and returned for safety follow-up.
Croatian: Bolesnici koji nisu odgovorili na infliksimab u 8. tjednu (n = 15) nisu dalje primali lijek i praćeni su radi ocjene sigurnosti primjene.