FrancophonIA/ELRC3.0 huggingface dataset:
English: In a main study that included 40 adults with multi-drug resistant HIV whose HIV treatment was failing, levels of HIV virus in the blood were undetectable (fewer than 50 copies/ml) in 43% of patients after 25 weeks of combining standard treatment with Trogarzo.
Croatian: U glavnom ispitivanju na 40 odraslih osoba s multirezistentnim virusom HIV-a kod kojih liječenje infekcije HIV-om nije bilo uspješno, razine virusa HIV-a u krvi bile su nemjerljive (manje od 50 kopija/ml) u 43 % bolesnika nakon 25 tjedana kombiniranog standardnog liječenja lijekom Trogarzo.
English: The active substance in Trogarzo, ibalizumab, is a monoclonal antibody (a type of protein) designed to attach to CD4, a receptor (target) found on the surface of immune cells called T cells.
Croatian: Djelatna tvar lijeka Trogarzo, ibalizumab, monoklonsko je protutijelo (vrsta bjelančevine) namijenjena vezivanju na CD4, receptor (ciljno mjesto) koji se nalazi na površini imunosnih stanica zvanih Tstanice.
English: Trogarzo is available as a solution for infusion (drip) into a vein.
Croatian: Lijek Trogarzo dostupan je kao otopina za infuziju (ukapavanje) u venu.
English: How does Trogarzo work?
Croatian: Kako djeluje Trogarzo?
English: What benefits of Trogarzo have been shown in studies?
Croatian: Koje su koristi od lijeka Trogarzo utvrđene u ispitivanjima?
English: Trogarzo taken with other HIV medicines was shown to be effective at reducing viral load (blood levels of HIV virus) in patients with multi-drug resistant HIV, that is, where standard HIV combination treatments have failed to suppress levels of HIV in the blood sufficiently.
Croatian: Kada se uzima s drugim lijekovima za liječenje infekcije HIV-om, Trogarzo se pokazao učinkovitim u smanjenju virusnog opterećenja (razine virusa HIV-a u krvi) u bolesnika s multirezistentnim virusom HIV-a, u kojih standardna kombinirana liječenja HIV-a nisu uspjela u dovoljnoj mjeri smanjiti razinu HIV-a u krvi.
English: For the full list of side effects and restrictions with Trogarzo, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s lijekom Trogarzo potražite u uputi o lijeku.
English: How is Trogarzo used?
Croatian: Kako se Trogarzo primjenjuje?
English: • Improve your physical function.
Croatian: • poboljšala Vaša fizička funkcionalnost.
English: Adults (≥ 18 years)
Croatian: Odrasli (≥ 18 godina)
English: • Your doctor will want to closely monitor your heart.
Croatian: • Vaš liječnik će htjeti pažljivo nadzirati Vaše srce.
English: Date of first authorisation: 13 August 1999.
Croatian: Datum prvog odobrenja: 13. kolovoza 1999.
English: Every 6 to 8 weeks depending on your disease
Croatian: Svakih 6 do 8 tjedana, ovisno o bolesti
English: EXP EXP, if not refrigerated ___________________
Croatian: EXP EXP, ako se ne čuva u hladnjaku_________
English: These children must be 6 years of age or older.
Croatian: Ta djeca moraju imati 6 ili više godina.
English: Some of these reactions may be serious or life-threatening.
Croatian: Neke od tih reakcija mogu biti ozbiljne ili opasne po život.
English: Date of latest renewal: 2 July 2009.
Croatian: Datum posljednje obnove odobrenja: 2. srpnja 2009.
English: Some of these patients have been under 50 years of age.
Croatian: Neki od tih bolesnika bili su mlađi od 50 godina.
English: Nearly 50% of reported deaths have been associated with infection.
Croatian: Gotovo 50% prijavljenih smrtnih slučajeva bilo je povezano s infekcijom.
English: Approximately 50% of patients were in functional Class III.
Croatian: Približno 50% bolesnika pripadalo je funkcionalnoj klasi III.
English: The available clinical experience is limited.
Croatian: Kliničko iskustvo je ograničeno.
English: PASI 75 response**
Croatian: Odgovor PASI 75**
English: Write the new expiry date on the carton including day/month/year.
Croatian: Zapišite novi rok valjanosti na kutiju uključujući dan/mjesec/godinu.
English: The median duration of response was 12 weeks.
Croatian: Medijan trajanja odgovora bio je 12 tjedana.
English: Patients with no deterioration/patients evaluated
Croatian: Bolesnici bez pogoršanja/evaluirani bolesnici
English: Allow the reconstituted solution to stand for 5 minutes.
Croatian: Ostavite rekonstituiranu otopinu da odstoji 5 minuta.
English: It is used in adults for the following inflammatory diseases:
Croatian: Koristi se u odraslih osoba za sljedeće upalne bolesti:
English: Total score d (van der
Croatian: Ukupan broj bodova d (van der
English: It is not known whether this finding was due to effects on the males and/or the females.
Croatian: Nije poznato je li ovaj učinak bio posljedica djelovanja na mužjake i/ili ženke.
English: • Depression, problems sleeping
Croatian: • depresija, poteškoće sa spavanjem
English: List of other medicines:
Croatian: Popis drugih lijekova:
English: • Eye problems, including red eyes and infections
Croatian: • problemi s očima, uključujući crvene oči i infekcije
English: • Your doctor or nurse will prepare the medicine for infusion.
Croatian: • Vaš liječnik ili medicinska sestra pripremit će lijek za infuziju.
English: What Remicade is and what it is used for
Croatian: Što je Remicade i za što se koristi
English: List of allergies:
Croatian: Popis alergija:
English: The information above also applies to children and adolescents.
Croatian: Gore navedene informacije odnose se i na djecu i adolescente.
English: Avoid prolonged or vigorous agitation.
Croatian: Izbjegavajte dugotrajno ili žustro mućkanje.
English: Fistula Response (%) Complete fistula response (%)
Croatian: Odgovor fistula (%) Potpuni odgovor fistula (%)
English: • Remicade will be given to you by your doctor or nurse.
Croatian: • Remicade će Vam dati Vaš liječnik ili medicinska sestra.
English: Median time to loss of response through week 54
Croatian: Medijan vremena do gubitka odgovora u razdoblju do 54. tjedna
English: In addition:
Croatian: Osim toga:
English: Telephone number doctor:
Croatian: Telefonski broj liječnika:
English: • Reduce the signs and symptoms of your disease
Croatian: • umanjili znakovi i simptomi bolesti
English: Remicade is also used in adults and children 6 years of age or older for:
Croatian: Remicade se također koristi u odraslih i djece u dobi od 6 ili više godina za liječenje:
English: placebo infliximab placebo infliximab placebo infliximab placebo infliximab
Croatian: placebo infliksimab placebo infliksimab placebo infliksimab placebo infliksimab
English: Remicade will generally be stored by the health professionals.
Croatian: Remicade će općenito čuvati zdravstveni radnici.
English: The effects observed at 54 weeks were maintained through 102 weeks.
Croatian: Učinci opaženi nakon 54 tjedna održali su se tijekom 102 tjedna.
English: After reconstitution and dilution:
Croatian: Nakon rekonstitucije i razrjeđivanja:
English: (anaphylactic shock)
Croatian: (anafilaktički šok)
English: The storage details should you need them are as follows:
Croatian: Uvjeti čuvanja, ako Vam zatrebaju, su sljedeći:
English: Combined data from ACT 1 & 2
Croatian: Zbirni podaci iz ACT 1 i ACT 2
English: Reduction in CDAI ≥ 25% and ≥ 70 points.
Croatian: Smanjenje CDAI ≥ 25% i ≥ 70 bodova.
English: The majority of serious infusion reactions occurred during the second infusion at week 2.
Croatian: Većina ozbiljnih reakcija na infuziju pojavila se tijekom druge infuzije u 2. tjednu.
English: For more information see section on Pregnancy and breast-feeding.
Croatian: Za više informacija pogledajte dio o trudnoći i dojenju.
English: • Severe allergic reaction that may cause loss of consciousness and could be life-threatening
Croatian: • teška alergijska reakcija koja može uzrokovati gubitak svijesti i može biti opasna po život
English: Week 26 All randomised patients
Croatian: 26. tjedan Svi randomizirani bolesnici
English: In addition, bone fracture (6.8%) was reported, however, a causal association has not been established.
Croatian: Osim toga, prijavljeni su i prijelomi kostiju (6,8%), ali nije utvrđena uzročna povezanost.
English: Other special considerations are discussed below.
Croatian: O ostalim posebnostima raspravlja se u daljnjem tekstu.
English: The majority (67%) of these patients did not require any dose titration.
Croatian: U većine bolesnika (67%) nije bila potrebna titracija doze.
English: Remicade must be given concomitantly with methotrexate.
Croatian: Remicade se mora davati istodobno s metotreksatom.
English: The median terminal half-life at these doses ranged from 8 to 9.5 days.
Croatian: Medijan konačnog poluvijeka pri ovim se dozama kretao u rasponu od 8 do 9,5 dana.
English: Do not use Remicade if any of the above applies to you.
Croatian: Nemojte primijeniti Remicade ako se nešto od navedenog odnosi na Vas.
English: • Fever, increased sweating
Croatian: • vrućica, pojačano znojenje
English: Approximately 93% of the patients had previously received antibiotic or immunosuppressive therapy.
Croatian: Približno 93% bolesnika prethodno je primalo antibiotsku ili imunosupresivnu terapiju.
English: All patients had experienced an inadequate response to prior conventional therapies.
Croatian: Svi su bolesnici imali neodgovarajući odgovor na prethodno konvencionalno liječenje.
English: Median follow-up is based on patients treated.
Croatian: Medijan praćenja temelji se na broju liječenih bolesnika.
English: • Hepatitis B infection when you have had hepatitis B in the past
Croatian: • infekcija hepatitisom B ako ste u prošlosti već imali hepatitis B
English: All infusion reactions were mild or moderate in intensity.
Croatian: Sve su reakcije na infuziju bile blagog ili umjerenog intenziteta.
English: Hepatitis B (HBV) reactivation
Croatian: Reaktivacija hepatitisa B (HBV)
English: Remicade belongs to a group of medicines called ‘TNF blockers'.
Croatian: Remicade pripada skupini lijekova koji se nazivaju "TNF-blokatorima".
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Croatian: Ovaj lijek primjenjuje liječnik ili medicinska sestra, stoga je mala vjerojatnost da ćete dobiti previše lijeka.
English: Remicade has not been studied in these patient populations.
Croatian: Remicade nije ispitivan u ovim populacijama bolesnika.
English: The new expiry date must be written on the carton.
Croatian: Novi rok valjanosti se mora napisati na kutiji.
English: For women taking Remicade including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Croatian: Ženama koje uzimaju Remicade, uključujući i one starije od 60 godina, liječnik može preporučiti redovite preglede za prevenciju raka grlića maternice.
English: The patient reminder card shall contain the following key messages:
Croatian: Kartica s podsjetnikom za bolesnika sadržavati će sljedeće ključne poruke:
English: Patients with ACR20 response/ Patients evaluated (%)
Croatian: Bolesnici s odgovorom ACR20/ evaluirani bolesnici (%)
English: • In some patients receiving Remicade, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
Croatian: • U nekih bolesnika koji primaju Remicade tijelo možda neće proizvoditi dovoljno krvnih stanica koje pomažu u borbi protiv infekcije ili pomažu zaustaviti krvarenje.
English: It is important that you and your doctor record the brand name and batch number of your medicine.
Croatian: Važno je da Vi i Vaš liječnik zabilježite zaštićeni naziv i broj serije Vašeg lijeka.
English: Results from week 54 are shown in Table 4.
Croatian: Rezultati nakon 54 tjedna prikazani su u Tablici 4.
English: This evaluation should include colonoscopy and biopsies per local recommendations.
Croatian: Kontrolni pregledi moraju obuhvatiti kolonoskopiju i biopsiju sukladno lokalnim preporukama.
English: Janssen Biotech Inc., 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, United States of America
Croatian: Janssen Biotech Inc., 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, Sjedinjene Američke Države
English: Cases of agranulocytosis have also been reported (see section 4.8).
Croatian: Također su prijavljeni i slučajevi agranulocitoze (vidjeti dio 4.8).
English: • Circulation problems such as low or high blood pressure
Croatian: • problemi s cirkulacijom kao što su nizak ili visok krvni tlak
English: Talk to your doctor if you are on a low salt diet.
Croatian: Obratite se svom liječniku ako ste na dijeti s ograničenim unosom soli.
English: Patients who have inflammatory diseases already take medicines to treat their problem.
Croatian: Bolesnici koji boluju od upalnih bolesti već uzimaju lijekove za liječenje svojih tegoba.
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 zoster (niti jedan ozbiljan).
English: These skin reactions can be accompanied by fever.
Croatian: Navedene kožne reakcije mogu biti praćene vrućicom.
English: ACR response (% of patients)
Croatian: ACR odgovor (% bolesnika)
English: • You will be monitored while you are given Remicade and also for 1 to 2 hours afterwards.
Croatian: • Bit ćete pod nadzorom dok primate Remicade, te 1 do 2 sata nakon toga.
English: What Remicade is and what it is used for What you need to know before you use Remicade How Remicade will be given Possible side effects
Croatian: Što je Remicade i za što se koristi Što morate znati prije nego počnete primati Remicade Kako primjenjivati Remicade Moguće nuspojave
English: Other medicines and Remicade
Croatian: Drugi lijekovi i Remicade
English: There is no evidence to suggest that infliximab worsens or causes fibrotic strictures.
Croatian: Nema dokaza koji bi ukazivali da infliksimab pogoršava ili uzrokuje fibrozne strikture.
English: No serious infusion reactions were reported.
Croatian: Nisu prijavljene ozbiljne reakcije na infuziju.
English: Between weeks 6 and 26, symptoms of psoriasis gradually returned with a median time to disease relapse of > 20 weeks.
Croatian: Između 6. i 26. tjedna simptomi psorijaze postupno su se vratili, uz medijan od > 20 tjedana do povratka bolesti.
English: Check that the solution is colourless to light yellow and opalescent.
Croatian: Provjerite je li otopina bezbojna do svijetložuta i opalescentna.
English: In particular, tell your doctor if you are using any of the following medicines:
Croatian: Posebice recite svom liječniku ako uzimate neki od sljedećih lijekova:
English: Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period.
Croatian: Budući da eliminacija infliksimaba može potrajati i do 6 mjeseci, bolesnik mora biti pod nadzorom i tijekom tog razdoblja.
English: In responding patients, the alternative strategies for continued treatment are:
Croatian: U bolesnika koji su odgovorili na terapiju, alternativne strategije za nastavak liječenja su sljedeće:
English: • You are allergic to infliximab or to any of the other ingredients in Remicade (listed in section 6).
Croatian: • Ako ste alergični na infliksimab ili neki drugi sastojak lijeka Remicade (naveden u dijelu 6).
English: Result:
Croatian: Rezultat:
English: Long-term studies have not been performed to evaluate the carcinogenic potential of infliximab.
Croatian: Nisu provedena dugotrajna istraživanja radi procjene kancerogenog potencijala infliksimaba.
English: It should be noted that suppression of TNF may mask symptoms of infection such as fever.
Croatian: Treba napomenuti da supresija TNFα može prikriti simptome infekcije poput vrućice.
English: The interval between the last maintenance dose and the first re-induction dose ranged from 35-231 days.
Croatian: Interval između zadnje doze održavanja i prve doze ponovljenog uvodnog režima liječenja kretao se od 35 do 231 dana.
English: No further clinically relevant accumulation was observed.
Croatian: Nije opažena daljnja klinički značajna akumulacija lijeka.
English: The median CDAI score was 180.
Croatian: Medijan aktivnosti mjeren na CDAI skali iznosio je 180.
English: Remicade has been studied only in combination with conventional immunosuppressive therapy.
Croatian: Remicade je ispitivan samo u kombinaciji s konvencionalnom imunosupresivnom terapijom.
English: Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
Croatian: Infliksimab prolazi kroz placentu i pronađen je u serumu dojenčadi do 6 mjeseci nakon rođenja.
English: Single doses up to 20 mg/kg have been administered without toxic effects.
Croatian: Primjena jednokratnih doza do 20 mg/kg nije izazvala toksične učinke.
English: An allergic reaction could happen within 2 hours of your injection or later.
Croatian: Alergijska reakcija može nastupiti u roku od 2 sata od primanja infuzije ili kasnije.
English: Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy.
Croatian: U oko 3% bolesnika liječenje je prekinuto zbog reakcija vezanih uz infuziju i svi su se bolesnici oporavili s ili bez medicinskog liječenja.
English: Acute infusion reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following infusion.
Croatian: Akutne reakcije vezane uz infuziju, uključujući anafilaktičke reakcije, mogu se razviti tijekom (u roku od nekoliko sekundi) ili unutar nekoliko sati nakon infuzije.
English: Side effects may occur a long time after your last dose.
Croatian: Nuspojave se mogu javiti dugo vremena nakon zadnje doze lijeka.
English: • Psoriasis, skin problems such as eczema and hair loss
Croatian: • psorijaza, problemi s kožom kao što su ekcemi i gubitak kose
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 bilo kakve 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: No specific ophthalmologic examinations have been performed in patients to investigate the relevance of this finding for humans.
Croatian: Nisu provedeni specifični oftalmološki pregledi u bolesnika kako bi se ispitala značajnost tog nalaza za ljude.
English: If acute infusion reactions occur, the infusion must be interrupted immediately.
Croatian: Ako se pojave akutne reakcije vezane uz infuziju, infuzija se mora odmah prekinuti.
English: N/A 6.7% N/A 1.7%
Croatian: N/P 6,7% N/P 1,7%
English: Antibodies to infliximab cannot always be detected in serum samples.
Croatian: Protutijela na infliksimab ne mogu se uvijek otkriti u uzorcima seruma.
English: • in combination with methotrexate
Croatian: • u kombinaciji 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 pretkliničkih podataka da bi se donio zaključak o utjecaju infliksimaba na plodnost i opću reproduktivnu funkciju (vidjeti dio 5.3).
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Remicade treatment.
Croatian: Žene reproduktivne dobi moraju razmotriti uporabu odgovarajuće kontracepcije kako bi se spriječila trudnoća i nastaviti je koristiti najmanje 6 mjeseci nakon primjene posljednje doze lijeka Remicade.
English: The powder is a freeze-dried white pellet.
Croatian: Prašak je liofilizirani bijeli pelet.
English: What you need to know before you use Remicade
Croatian: Što morate znati prije nego počnete primati Remicade
English: Key efficacy results for IMPACT and IMPACT 2 are shown in Table 9 below:
Croatian: Najvažniji rezultati za djelotvornost u ispitivanjima IMPACT i IMPACT 2 prikazani su u Tablici 9:
English: Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2 IMPACT
Croatian: Tablica 9 Učinci na ACR i PASI u ispitivanjima IMPACT i IMPACT 2
English: • Your doctor should test you for hepatitis B virus.
Croatian: • Liječnik Vas treba testirati na virus hepatitisa B.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Unutar klasifikacije organskih sustava, nuspojave su navedene prema sljedećim kategorijama učestalosti pojavljivanja: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko( ≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: * including bovine tuberculosis (disseminated BCG infection), see section 4.4
Croatian: * uključujući goveđu tuberkulozu (diseminiranu BCG infekciju), vidjeti dio 4.4.
English: 6 weeks after your 1
Croatian: 6 tjedana nakon 1. doze
English: These infections are caused by specific types of fungi that can affect the lungs or other parts of your body.
Croatian: Ove infekcije uzrokuje posebna vrsta gljivica koja može zahvatiti pluća ili druge dijelove tijela.
English: A low proportion of the infusion reactions was serious allergic reactions.
Croatian: Mali udio reakcija vezanih uz infuziju činile su teške alergijske reakcije.
English: Remicade is available in packs of 1, 2, 3, 4 or 5 vials.
Croatian: Remicade je dostupan u pakiranjima od 1, 2, 3, 4 ili 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: Instructions for use and handling - storage conditions
Croatian: Upute za uporabu i rukovanje - uvjeti čuvanja
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 do 11 godina i onoj od 12 do 17 godina.
English: • Reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery.
Croatian: • smanjio broj neprirodnih otvora (fistula) između crijeva i kože koji nisu bili zbrinuti drugim lijekovima ili kirurškim putem.
English: • It is recommended that when Remicade is prepared for infusion, it is used as soon as possible (within 3 hours).
Croatian: • Preporučuje se pripremljenu otopinu za infuziju lijeka Remicade upotrijebiti što prije (u roku od 3 sata).
English: Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
Croatian: Remicade je u kombinaciji s metotreksatom indiciran za smanjivanje znakova i simptoma te poboljšavanje fizičkih funkcija u:
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Croatian: Dostupni podaci pokazuju da se klinički odgovor obično postiže u roku od 12 tjedana liječenja.
English: The relative deficiency of TNF caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Croatian: Relativno pomanjkanje TNFα prouzročeno anti-TNF terapijom može pokrenuti autoimuni proces.
English: The potential risk with the combination of AZA or 6-MP and Remicade should be carefully considered.
Croatian: Treba pomno razmotriti potencijalni rizik primjene kombinacije AZA odnosno 6-MP i lijeka Remicade.
English: Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
Croatian: Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, Nizozemska