FrancophonIA/ELRC3.0 huggingface dataset:
English: DISPOSAL AND CARE Dispose of the used pre-filled syringe
Croatian: ODLAGANJE I ZBRINJAVANJE Zbrinite upotrijebljenu napunjenu štrcaljku
English: During the first 60 days of pregnancy, both too high and too low vitamin A levels may be associated with an increased risk of foetal malformation.
Croatian: Tijekom prvih 60 dana trudnoće previsoke ili preniske razine vitamina
English: Put the used pre-filled syringe in a sharps disposal container right away after use.
Croatian: Stavite upotrijebljenu napunjenu štrcaljku u spremnik za oštre predmete nakon uporabe.
English: If you miss your dose of Tegsedi, then you should have your next dose as soon as possible, unless the next scheduled dose is within two days, in which case the missed dose should be skipped and the next dose given at the scheduled time.
Croatian: Ako ste propustili dozu lijeka Tegsedi, morate primijeniti sljedeću dozu što prije, osim ako je sljedeća planirana doza unutar dva dana jer u tom slučaju propuštenu dozu treba preskočiti i primijeniti sljedeću dozu u predviđeno vrijeme.
English: Transient increases of CRP and platelet levels may occur in some patients after initiation of inotersen.
Croatian: U nekih bolesnika moguća su prolazna povećanja razine CRP-a i trombocita nakon početka primjene inotersena.
English: Tegsedi may reduce cells in the blood responsible for clotting of the blood (platelets), which may result in a condition called thrombocytopenia (see section 4).
Croatian: Tegsedi može smanjiti broj stanica u krvi koje su odgovorne za zgrušavanje krvi (trombociti), što može rezultirati stanjem koje se naziva trombocitopenija (vidjeti dio 4).
English: In the event of an unplanned pregnancy, inotersen should be discontinued.
Croatian: U slučaju neplanirane trudnoće, potrebno je prekinuti primjenu inotersena.
English: Do not stop using Tegsedi unless your doctor tells you to.
Croatian: Ako prestanete primjenjivati Tegsedi Nemojte prestati primjenjivati Tegsedi osim ako Vam to nije rekao liječnik.
English: Early initiation of immunosuppressive therapy should be considered if a diagnosis of glomerulonephritis is confirmed.
Croatian: Potrebno je uzeti u obzir rani početak imunosupresijske terapije ako je potvrđena dijagnoza glomerulonefritisa.
English: Tegsedi can lower your body's levels of vitamin A (also called retinol).
Croatian: Tegsedi može smanjiti razine vitamina A (poznatog i kao retinol) u Vašem tijelu.
English: It is used to treat adults with hereditary transthyretin amyloidosis.
Croatian: Koristi se u liječenju odraslih s nasljednom transtiretinskom amiloidozom.
English: Do not remove any air bubbles from the pre-filled syringe.
Croatian: Nemojte uklanjati mjehuriće zraka iz napunjene štrcaljke.
English: Treatment should be initiated by and remain under the supervision of a physician experienced in the treatment of patients with hereditary transthyretin amyloidosis.
Croatian: Liječenje treba započeti i nastaviti nadzirati liječnik s iskustvom u liječenju bolesnika s nasljednom transtiretinskom amiloidozom.
English: The solution should be clear and colourless to pale yellow.
Croatian: Otopina mora biti bistra i bezbojna do blijedožuta.
English: Check medicine in the pre-filled syringe
Croatian: Provjerite lijek u napunjenoj štrcaljki
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svakog organskog sustava nuspojave su razvrstane prema učestalosti, a prvo je navedena najčešća nuspojava.
English: Severe platelet declines in association with increased bleeding or bruising were observed in individual monkeys.
Croatian: Veliko smanjenje broja trombocita vezano uz povećano krvarenje ili povećanu pojavu modrica opaženo je u pojedinim majmunima.
English: Extensive and persistent uptake of inotersen was observed by various cell types in multiple organs of all tested animal species including monocytes/macrophages, kidney proximal tubular epithelia, Kupffer cells of the liver, and histiocytic cell infiltrates in lymph nodes and injection sites.
Croatian: Opsežno i perzistirajuće nakupljanje inotersena opaženo je u raznim vrstama stanica raznih organa svih ispitivanih životinjskih vrsta, uključujući monocite/makrofage, epitel proksimalnih bubrežnih kanalića, Kupfferove stanice jetre i histiocitne stanične infiltrate u limfnim čvorovima i na mjestima injekcije.
English: Due to the long half-life of inotersen (see section 5.2), a vitamin A deficit may even develop after cessation of treatment.
Croatian: Zbog dugog poluvijeka inotersena (vidjeti dio 5.2), do nedostatka vitamina
English: If you stop taking Tegsedi then your blood levels should be checked 8 weeks after discontinuation.
Croatian: Ako prestanete uzimati Tegsedi trebate provjeravati razine u krvi 8 tjedana nakon prekida uzimanja lijeka.
English: Symptoms of glomerulonephritis are foaming urine, pink or brown coloured urine, blood in the urine, and passing less urine than usual.
Croatian: Simptomi glomerulonefritisa su pjenjenje mokraće, bojanje mokraće ružičastom ili smeđom bojom, krv u mokraći i mokrenje manje nego obično.
English: Inotersen should not be used in patients with a urine protein to creatinine ratio (UPCR) ≥ 113 mg/mmol (1 g/g) or estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2 (see section 4.3).
Croatian: Inotersen se ne smije primjenjivati u bolesnika s omjerom proteina i kreatinina u urinu (UPCR) ≥113 mg/mmol (1 g/g) ili procijenjenom brzinom glomerularne filtracije (eGFR) <45 ml/min/1,73m
English: Both inotersen and its shorter oligonucleotide metabolites are excreted in human urine.
Croatian: Inotersen i njegovi kraći metaboliti, oligonukleotidi, izlučuju se u urinu ljudi.
English: Subgroup Analysis of mNIS+7 and Norfolk QoL-DN mNIS+7
Croatian: Tablica 5. Analiza mNIS+7 i Norfolk QoL-DN prema podskupinama mNIS+7
English: Twice weekly until 3 successive values above 75 then weekly monitoring.
Croatian: Dvaput tjedno do postizanja 3 puta zaredom vrijednosti iznad 75, zatim tjedno praćenje.
English: 1.5 mL solution in a clear Type 1 glass pre-filled syringe.
Croatian: 1,5 ml otopine u napunjenoj štrcaljki od prozirnog stakla tipa 1
English: Do not move the plunger.
Croatian: Nemojte pomicati klip.
English: A responder was defined as a subject who had a change from baseline that was less than or equal to the threshold value.
Croatian: Bolesnik koji je odgovorio na liječenje definiran je kao ispitanik koji je imao promjenu od početne vrijednosti manju ili jednaku vrijednosti praga.
English: Choose an injection site on your abdomen (belly) or the front of your thigh.
Croatian: Izaberite mjesto injiciranja na trbuhu ili prednjoj strani natkoljenice.
English: Renal function decline has also been observed in a number of subjects without signs of glomerulonephritis (see section 4.8).
Croatian: Također je opaženo smanjenje funkcije bubrega u nekoliko ispitanika bez znakova glomerulonefritisa (vidjeti dio 4.8).
English: Tegsedi may be stored unrefrigerated for up to 6 weeks at a temperature below 30°C.
Croatian: Tegsedi se može čuvati izvan hladnjaka do 6 tjedana na temperaturi ispod 30°C.
English: The changes from baseline in both primary endpoints (mNIS+7 and Norfolk QoL-DN) demonstrated statistically significant benefit in favour of inotersen treatment at Week 66 (Table 4).
Croatian: Promjene u odnosu na početne vrijednosti u objema primarnim mjerama ishoda (mNIS+7 i Norfolk QoL-DN) dokazale su statistički značajne koristi liječenja inotersenom u 66. tjednu (Tablica 4).
English: P-value n (Placebo, Inotersen)
Croatian: p-vrijednost n (placebo, inotersen)
English: Patients should be monitored for signs and symptoms of transplant rejection during treatment with Inotersen.
Croatian: Bolesnike treba nadzirati kako bi se uočili znakovi i simptomi odbacivanja presatka tijekom liječenja inotersenom.
English: Therefore, pregnancy should be excluded before treatment initiation and women of childbearing potential should practise effective contraception (see section 4.6).
Croatian: Stoga je potrebno isključiti trudnoću prije početka liječenja, a žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju (vidjeti dio 4.6).
English: Contact your doctor or pharmacist, or go to a hospital emergency department immediately, even if you have no symptoms.
Croatian: Ako primijenite više lijeka Tegsedi nego što ste trebali Odmah se obratite svom liječniku ili ljekarniku, ili idite na hitni prijem, čak i ako nemate simptoma.
English: Slowly and firmly push the plunger down
Croatian: Polako i čvrsto gurnite klip prema dolje
English: Thus, pharmacokinetics should not be altered in mild to moderate hepatic impairment.
Croatian: Stoga farmakokinetika ne bi smjela biti izmijenjena u blagom do umjerenom oštećenju funkcije jetre.
English: Because of the risk of glomerulonephritis and possible renal function decline, UPCR and eGFR should be monitored during treatment with inotersen (see section 4.4).
Croatian: Zbog rizika od glomerulonefritisa i mogućeg smanjenja funkcije bubrega, potrebno je tijekom liječenja inotersenom pratiti UPCR i eGFR (vidjeti dio 4.4).
English: You should consult your doctor if you should either stop breastfeeding or stop the treatment with Tegsedi.
Croatian: Morate se savjetovati s liječnikom bilo da želite prestati dojiti ili prekinuti uzimati lijek Tegsedi.
English: Change from Baseline Inotersen - Placebo
Croatian: Promjena od početne vrijednosti inotersen - placebo
English: Referral for ophthalmological assessment is recommended if patients develop ocular symptoms consistent with vitamin A deficiency, incuding: reduced night vision or night blindness, persistent dry eyes, eye inflammation, corneal inflammation or ulceration, corneal thickening, corneal perforation.
Croatian: Preporučuje se upućivanje oftalmologu ako bolesnici razviju okularne simptome koji odgovaraju nedostatku vitamina A, uključujući: smanjen noćni vid ili noćnu sljepoću, ustrajno suhe oči, upalu oka, upalu ili ulkus rožnice, zadebljanje rožnice, perforaciju rožnice.
English: Tegsedi may pass into breast milk.
Croatian: Postoji mogućnost da se Tegsedi izlučuje u majčino mlijeko.
English: Inotersen will reduce the plasma levels of vitamin A, which is crucial for normal foetal development.
Croatian: Inotersen će smanjiti razine vitamina A u plazmi, koji je ključan za normalan razvoj ploda.
English: Special caution should be used in elderly patients, in patients taking anithrombotic medicinal products, antiplatelet medicinal products, or medicinal products that may lower platelet count (see section 4.5), and in patients with prior history of major bleeding events.
Croatian: Potreban je poseban oprez u starijih bolesnika, u bolesnika koji uzimaju anitrombotske lijekove, antitrombocitne lijekove ili lijekove koji mogu smanjiti broj trombocita (vidjeti dio 4.5) te u bolesnika s događajima velikog krvarenja u povijesti bolesti.
English: If you are using any medicines that damage the kidney or affect kidney function, for example sulfonamides, aldosterone antagonists, and some types of painkillers, you should tell your doctor.
Croatian: Ako koristite bilo koje lijekove koji oštećuju funkciju bubrega ili utječu na funkciju bubrega, primjerice sulfonamidi, antagonisti aldosterona, određene vrste lijekova protiv bolova, trebate obavijestiti svog liječnika.
English: Slowly lift up on the plunger and let the safety spring push the plunger up automatically.
Croatian: Polako podignite prst kojim pritišćete klip i pustite da sigurnosna opruga automatski gurne klip prema gore.
English: Clean the injection site with an alcohol wipe in a circular motion.
Croatian: Kružnim pokretima očistite mjesto injiciranja alkoholnom maramicom.
English: WARNINGS
Croatian: UPOZORENJA
English: Due to the prolonged activity of Tegsedi, however, your reduced vitamin A levels may persist.
Croatian: Međutim, zbog produžene aktivnosti lijeka Tegsedi, mogu i dalje postojati smanjene razine vitamina A.
English: The kidney accumulation of inotersen was associated with proteinuria in rats at 13.4-fold the human AUC at the recommended therapeutic inotersen dose.
Croatian: Nakupljanje inotersena u bubrezima bilo je povezano s proteinurijom u štakora pri AUC-u koji je iznosio 13,4x AUC-a u ljudi pri preporučenoj terapijskoj dozi inotersena.
English: If acute glomerulonephritis is confirmed, permanent discontinuation of the treatment should be considered.
Croatian: Ako je akutni glomerulonefritis potvrđen, potrebno je uzeti u obzir trajni prekid liječenja.
English: Patients with UPCR more than or equal to twice the upper limit of normal, or eGFR < 60 ml/min, which is confirmed on repeat testing and in the absence of an alternative explanation, should be monitored every 4 weeks.
Croatian: Potrebno je pratiti svaka 4 tjedna bolesnike sa UPCR-om većim ili jednakim dvostrukoj vrijednosti gornje granice normale, ili eGFR-om <60 ml/min koji su potvrđeni ponovljenim testiranjem i ako ne postoji drukčije objašnjenje.
English: If you let go of the plunger too quickly, you may lose some of the medicine.
Croatian: Ako klip prebrzo pustite možda se neće injicirati cijela količina lijeka.
English: In monkeys, perivascular cell infiltration by lymphohistiocytic cells in multiple organs was noted.
Croatian: U majmuna, opažena je perivaskularna stanična infiltracija limfohistiocitnih stanica u raznim organima.
English: The active substance in Tegsedi, inotersen, is a type of medicine called an antisense oligonucleotide inhibitor.
Croatian: Inotersen je aktivna tvar u lijeku Tegsedi i vrsta je lijeka koja se naziva inhibitorom antisens oligonukleotida.
English: Estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m
Croatian: Procijenjena brzina glomerularne filtracije (eGFR) <45 ml/min/1,73m Teško oštećenje funkcije jetre
English: What Tegsedi looks like and contents of the pack
Croatian: Kako Tegsedi izgleda i sadržaj pakiranja
English: If any of the above happens, throw away the pre-filled syringe in a puncture-resistant (sharps) container and use a new pre-filled syringe.
Croatian: Ako se dogodi bilo što od navedenog, bacite napunjenu štrcaljku u spremnik za oštre predmete i upotrijebite novu napunjenu štrcaljku.
English: Patients should be monitored for signs of increased proteinuria and reduction in eGFR during treatment with inotersen (see section 4.4).
Croatian: Bolesnike treba nadzirati kako bi se uočili znakovi povećane proteinurije i smanjenja eGFR-a tijekom liječenja inotersenom (vidjeti dio 4.4).
English: Caution should be used with nephrotoxic medicinal products and other medicinal products that may impair renal function (see section 4.5).
Croatian: Potreban je oprez s nefrotoksičnim lijekovima i drugim lijekovima koji mogu narušiti funkciju bubrega (vidjeti dio 4.5).
English: Tegsedi may be stored unrefrigerated for up to 6 weeks below 30 °C.
Croatian: Tegsedi se može čuvati izvan hladnjaka do 6 tjedana ispod 30 °C.
English: It is unknown whether inotersen/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se inotersen/metaboliti u majčino mlijeko.
English: You should either gently pinch the skin at the injection site or give the injection without pinching the skin.
Croatian: Kožu na mjestu injiciranja nježno uhvatite između palca i kažiprsta ili primijenite injekciju bez da tako uhvatite kožu.
English: Decreased platelet counts were observed in chronic toxicity studies in mice, rats and monkeys at 1.4 to 2-fold the human AUC at the recommended therapeutic inotersen dose.
Croatian: Smanjeni broj trombocita opažen je u ispitivanjima kronične toksičnosti u miševa, štakora i majmuna pri AUC-u koji iznosi 1,4 do 2x AUC-a u ljudi pri preporučenoj terapijskoj dozi inotersena.
English: Do not use this medicine after the expiry date, which is stated on the carton, tray and on the pre-filled syringe after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, plastičnom podlošku i napunjenoj štrcaljki iza oznake „Rok valjanosti” i „EXP”.
English: Stage 2
Croatian: 2. stadij
English: There are no or limited amount of data from the use of inotersen in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni inotersena u trudnica ograničeni.
English: List of adverse reactions in clinical studies
Croatian: Tablica 2. Popis nuspojava u kliničkim ispitivanjima
English: Caution should be exercised with concomitant use of nephrotoxic medicinal products and other medicines that may impair renal function, such as sulfonamides, aldosterone antagonists, anilides, natural opium alkaloids and other opiods (see section 4.4).
Croatian: Potreban je oprez kod istodobne primjene nefrotoksičnih lijekova i drugih lijekova koji mogu narušiti funkciju bubrega, kao što su sulfonamidi, antagonisti aldosterona, anilidi, prirodni alkaloidi opijuma i drugi opioidi (vidjeti dio 4.4).
English: Start the injection
Croatian: Započnite injiciranje
English: The recommended dose is 284 mg inotersen by subcutaneous injection.
Croatian: Preporučena doza je 284 mg inotersena primijenjeno supkutanom injekcijom.
English: Difference in Least Squares Mean (LSM) Change from Baseline Between Treatment Groups in mNIS+7 and Components
Croatian: Razlika u promjeni srednje vrijednosti dobivene metodom najmanjih kvadrata (LSM) u odnosu na početne vrijednosti između terapijskih skupina u mNIS+7 i njegovim sastavnim dijelovima
English: No data are available in patients with severe renal impairment.
Croatian: Nema dostupnih podataka u bolesnika s teškim oštećenjem funkcije bubrega.
English: If you are a woman of child-bearing age, you should practise effective contraception and any pregnancy should be excluded before starting the treatment with Tegsedi.
Croatian: Ako ste žena reproduktivne dobi, morate koristiti učinkovitu kontracepciju i potrebno je isključiti trudnoću prije početka liječenja lijekom Tegsedi.
English: Patients and/or caregivers should be trained in the subcutaneous administration of Tegsedi.
Croatian: Bolesnike i/ili skrbnike potrebno je educirati za supkutanu primjenu lijeka Tegsedi.
English: Tegsedi should not be injected into areas of skin disease or injury.
Croatian: Tegsedi se ne smije injektirati u područja oboljele ili oštećene kože.
English: Three (3%) patients developed platelet counts < 25 x 10
Croatian: U tri (3%) bolesnika zabilježeni broj trombocita bio je <25x10
English: Tegsedi has no or negligible influence on the ability to drive and use machines.
Croatian: Tegsedi ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Inotersen has not been evaluated in patients undergoing liver transplant.
Croatian: Inotersen nije procijenjivan u bolesnika koji se podvrgavaju transplantaciji jetre.
English: Patients should be instructed to report to their physician immediately if they experience any signs of unusual or prolonged bleeding (e.g. petechia, spontaneous bruising, subconjunctival bleeding, nosebleeds), neck stiffness or atypical severe headache.
Croatian: Bolesnike treba upozoriti da odmah prijave liječniku ako primjete znakove neuobičajenog ili produženog krvarenja (npr. petehija, spontanu pojavu modrica, supkonjunktivalno krvarenje, krvarenje iz nosa), ukočen vrat ili atipična jaka glavobolja.
English: It is, therefore, recommended that dosing of inotersen should be discontinued in subjects undergoing liver transplantation.
Croatian: Stoga se preporučuje prekid primjene inotersena u ispitanika koji se podvrgavaju transplantaciji jetre.
English: Your doctor will check your kidney function before treatment and regularly during treatment with Tegsedi.
Croatian: Vaš liječnik će Vam provjeriti funkcije bubrega prije liječenja i redovito tijekom liječenja lijekom Tegsedi.
English: Choose the injection site
Croatian: Izaberite mjesto injiciranja
English: It is unknown if vitamin A supplementation can compensate for the risk of vitamin A deficiency that might affect your unborn child (see “Warnings and precautions” above).
Croatian: A koji može utjecati na Vaše nerođeno dijete (vidjeti “Upozorenja i mjere opreza” iznad).
English: The injection site may also be on the outer area of the upper arm if Tegsedi is administered by a caregiver.
Croatian: Mjesto injiciranja može također biti vanjsko područje nadlaktice ako Vam lijek Tegsedi primjeni njegovatelj.
English: For this reason, pregnancy should be excluded before initiation of inotersen therapy and women of child-bearing potential should practise effective contraception.
Croatian: Zbog tih razloga potrebno je isključiti trudnoću prije početka liječenja inotersenom, a žene reproduktivne dobi trebaju koristiti učinkovitu kontracepciju.
English: Previous use of stabilisers p<0.001
Croatian: Prethodna primjena stabilizatora p<0,001
English: Your doctor will monitor you regularly for this during treatment with Tegsedi.
Croatian: Liječnik će Vas vezano uz to redovito nadzirati tijekom liječenja lijekom Tegsedi.
English: - Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia) - Headache - Vomiting, or nausea (feeling sick) - Increase in body temperature - Feeling cold (chills) or shivering - Injection site pain, redness, itching or bruising - Swelling of the ankles, feet or fingers (peripheral oedema)
Croatian: - smanjeni broj crvenih krvnih stanica, što može izazvati bljedilo kože te dovesti do slabosti ili nedostatak zraka (anemija) - glavobolja - povraćanje, ili mučnina - povišenje tjelesne temperature - osjećaj hladnoće (zimica) ili drhtanje - bol na mjestu injekcije, crvenilo, svrbež ili modrice - oticanje gležnjeva, stopala ili prstiju (periferni edem)
English: Therefore women of child-bearing age should exclude any pregnancy, before treatment initiation with Tegsedi and should practise effective contraception (see section “Pregnancy and breast-feeding” below).
Croatian: Stoga, žene u reproduktivnoj dobi moraju isključiti trudnoću prije početka liječenja lijekom Tegsedi i trebaju koristiti učinkovitu kontracepciju (vidjeti dio „Trudnoća i dojenje“ u nastavku).
English: If you stop taking Tegsedi then your kidney function should be checked 8 weeks after discontinuation.
Croatian: Ako prestanete uzimati Tegsedi trebate provjeravati funkcije bubrega 8 tjedana nakon prekida uzimanja lijeka.
English: Sites for injection include the abdomen, upper thigh region, or outer area of the upper arm.
Croatian: Mjesta za injekciju uključuju abdomen, prednji dio natkoljenice, ili vanjsko područje nadlaktice.
English: Do not hold the pre-filled syringe by the plunger or push against the plunger to insert the needle.
Croatian: Nemojte držati napunjenu štrcaljku za klip ili gurati klip dok uvodite iglu.
English: A population pharmacokinetic analysis suggests that mild and moderate renal impairment has no clinically relevant effect on the systemic exposure of inotersen.
Croatian: Populacijska farmakokinetička analiza ukazuje da blago i umjereno oštećenje funkcije bubrega nema klinički značajnog utjecaja na sistemsku izloženost inotersenu.
English: Clean the injection site
Croatian: Očistite mjesto injiciranja
English: Complete the injection
Croatian: Dovršite injiciranje
English: Do not pull the plunger up by hand.
Croatian: Nemojte povlačiti klip prema gore.
English: Table 2 presents the adverse reactions (ADRs) listed by MedDRA system organ class.
Croatian: Tablica 2 prikazuje nuspojave navedene prema MedDRA klasifikaciji organskih sustava.
English: Your doctor will check your blood for levels of platelets before treatment and regularly during treatment with Tegsedi.
Croatian: Vaš liječnik će Vam provjeriti razine trombocita u krvi prije liječenja i redovito tijekom liječenja lijekom Tegsedi.
English: Baseline demographics
Croatian: Početni demografski podaci
English: • Let the pre-filled syringe reach room temperature (20 °C to 25 °C) for 30 minutes before injecting it. Do not warm the pre-filled syringe in any other way.
Croatian: • Prije injiciranja pričekajte 30 minuta, da napunjena štrcaljka dostigne sobnu temperaturu (od 20 °C do 25 °C).
English: Stage II Disease p<0.001
Croatian: 2. stadij bolesti p<0,001
English: Driving and using machines Use of Tegsedi has not been shown to affect ability to drive or use machinery.
Croatian: Upravljanje vozilima i strojevima Primjena lijeka Tegsedi ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.