FrancophonIA/ELRC3.0 huggingface dataset:
English: CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 140 mg
Croatian: KUTIJA KOJA SADRŽI 1 BOCU SA 5 ILI 20 TVRDIH KAPSULA LIJEKA TEMODAL 140 mg
English: The hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink.
Croatian: Tvrde kapsule imaju bijelo neprozirno tijelo s neprozirnom zelenom kapicom i označene su crnom tintom.
English: The body is imprinted with "100 mg", the Schering-Plough logo and two stripes.
Croatian: Na tijelu su otisnute oznake "100 mg", logo Schering-Plough i dvije pruge.
English: - diabetes insipidus (symptoms include increased urination and feeling thirsty), low potassium level in the blood - mood swings, hallucination - partial paralysis, change in your sense of smell - hearing impairment, infection of the middle ear - palpitations (when you can feel your heart beat), hot flushes - swollen stomach, difficulty controlling your bowel movements, haemorrhoids, dry mouth - hepatitis and injury to the liver (including fatal liver failure), cholestasis, increased bilirubin - blisters on body or in mouth, skin peeling, skin eruption, painful reddening of the skin, severe rash with skin swelling (including palms and soles) - increased sensitivity to sunlight, urticaria (hives), increased sweating, change in skin colour - difficulty in urinating - vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, sexual impotence - shivering, face swelling, discolouration of the tongue, thirst, tooth disorder
Croatian: - sekundarni rak, uključujući leukemiju - smanjen broj krvnih stanica (pancitopenija, anemija, leukopenija) - crvene potkožne mrlje - dijabetes insipidus (simptomi uključuju pojačano mokrenje i žeđ), niska razina kalija u krvi - promjene raspoloženja, halucinacije - djelomična paraliza, promjena osjeta mirisa - oštećenje sluha, infekcija srednjeg uha - palpitacije (osjećaj lupanja srca), navale vrućine - oticanje trbuha, poteškoće s kontroliranjem stolice, hemoroidi, suha usta - hepatitis i oštećenje jetre (uključujući zatajenje jetre sa smrtnim ishodom), kolestaza (otežan protok žuči), povišene vrijednosti bilirubina - mjehurići po tijelu ili u ustima, ljuštenje kože, izbijanje kožnih promjena, bolno crvenilo kože,
English: EU/1/98/096/013 (5 hard capsules) EU/1/98/096/014 (20 hard capsules)
Croatian: EU/1/98/096/013 (5 tvrdih kapsula) EU/1/98/096/014 (20 tvrdih kapsula)
English: CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 180 mg
Croatian: KUTIJA KOJA SADRŽI 1 BOCU SA 5 ILI 20 TVRDIH KAPSULA LIJEKA TEMODAL 180 mg
English: 5 days followed by 23 days without treatment.
Croatian: Temodal jedanput na dan tijekom 5 dana, nakon čega slijede 23 dana bez lijeka Temodal.
English: LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 20 mg
Croatian: NALJEPNICA ZA BOCE KOJE SADRŽE 5 ILI 20 TVRDIH KAPSULA LIJEKA TEMODAL 20 mg
English: CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 100 mg
Croatian: KUTIJA KOJA SADRŽI 1 BOCU SA 5 ILI 20 TVRDIH KAPSULA LIJEKA TEMODAL 100 mg
English: EU/1/98/096/021 (5 hard capsules) EU/1/98/096/022 (20 hard capsules)
Croatian: EU/1/98/096/021 (5 tvrdih kapsula) EU/1/98/096/022 (20 tvrdih kapsula)
English: EU/1/98/096/019 (5 hard capsules) EU/1/98/096/020 (20 hard capsules)
Croatian: EU/1/98/096/019 (5 tvrdih kapsula) EU/1/98/096/020 (20 tvrdih kapsula)
English: CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 5 mg INDIVIDUALLY SEALED IN SACHETS
Croatian: KUTIJA KOJA SADRŽI 5 ILI 20 TVRDIH KAPSULA LIJEKA TEMODAL 5 mg POJEDINAČNO ZATVORENIH
English: The hard capsules have an opaque white body, an opaque orange cap, and are imprinted with black ink.
Croatian: Tvrde kapsule imaju bijelo neprozirno tijelo s neprozirnom narančastom kapicom i označene su crnom tintom.
English: EU/1/98/096/003 (5 hard capsules) EU/1/98/096/004 (20 hard capsules)
Croatian: EU/1/98/096/003 (5 tvrdih kapsula) EU/1/98/096/004 (20 tvrdih kapsula)
English: EU/1/98/096/007 (5 hard capsules) EU/1/98/096/008 (20 hard capsules)
Croatian: EU/1/98/096/007 (5 tvrdih kapsula) EU/1/98/096/008 (20 tvrdih kapsula)
English: CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 5 mg
Croatian: KUTIJA KOJA SADRŽI 1 BOCU SA 5 ILI 20 TVRDIH KAPSULA LIJEKA TEMODAL 5 mg
English: EU/1/98/096/009 (5 hard capsules) EU/1/98/096/010 (20 hard capsules)
Croatian: EU/1/98/096/009 (5 tvrdih kapsula) EU/1/98/096/010 (20 tvrdih kapsula)
English: The major route of
Croatian: Waarderweg 39
English: EU/1/98/096/005 (5 hard capsules) EU/1/98/096/006 (20 hard capsules)
Croatian: EU/1/98/096/005 (5 tvrdih kapsula) EU/1/98/096/006 (20 tvrdih kapsula)
English: CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 100 mg INDIVIDUALLY SEALED IN SACHETS
Croatian: KUTIJA KOJA SADRŽI 5 ILI 20 TVRDIH KAPSULA LIJEKA TEMODAL 100 mg POJEDINAČNO ZATVORENIH
English: CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 20 mg INDIVIDUALLY SEALED IN SACHETS
Croatian: KUTIJA KOJA SADRŽI 5 ILI 20 TVRDIH KAPSULA LIJEKA TEMODAL 20 mg POJEDINAČNO ZATVORENIH
English: How to use Temodal
Croatian: Kako primjenjivati Temodal
English: - loss of weight, weight gain - radiation injury
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU DOZNOJ JEDINICI LIJEKA
English: Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172), red iron oxide (E 172)
Croatian: Ovojnica kapsule: želatina titanijev dioksid (E171) natrijev laurilsulfat željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate , indigo carmine (E 132),
Croatian: Ovojnica kapsule: želatina titanijev dioksid (E171) natrijev laurilsulfat indigo karmin (E132)
English: 9/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia,
Croatian: - nehematološka toksičnost prema općim kriterijima toksičnosti (engl. common toxicity criteria,
English: EU/1/98/096/001 (5 hard capsules) EU/1/98/096/002 (20 hard capsules)
Croatian: EU/1/98/096/001 (5 tvrdih kapsula) EU/1/98/096/002 (20 tvrdih kapsula)
English: Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172)
Croatian: Ovojnica kapsule: želatina titanijev dioksid (E171) natrijev laurilsulfat željezov oksid, žuti (E172)
English: EU/1/98/096/015 (5 hard capsules) EU/1/98/096/016 (20 hard capsules
Croatian: EU/1/98/096/015 (5 tvrdih kapsula) EU/1/98/096/016 (20 tvrdih kapsula)
English: Tel: +351 21 446 57 00 inform_pt@merck.com
Croatian: Merck Sharp & Dohme, Lda Tel: +351 21 446 57 00 inform_pt@merck.com
English: CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 20 mg
Croatian: KUTIJA KOJA SADRŽI 1 BOCU SA 5 ILI 20 TVRDIH KAPSULA LIJEKA TEMODAL 20 mg
English: Adverse reactions in patients treated with temozolomide Ear and labyrinth disorders
Croatian: Nakon peroralne primjene temozolomida označenog radioizotopom
English: Your doctor will help you decide what is best for you and your child.
Croatian: Liječnik će Vam pomoći da odlučite što je najbolje za Vas i Vaše dijete.
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzimajte ovaj lijek točno kako Vam je rekao Vaš liječnik.
English: Date of latest renewal: 23 April 2014
Croatian: Datum posljednje obnove: 23. travnja 2014.
English: After first opening the bottle: 1 month.
Croatian: Nakon prvog otvaranja boce: 1 mjesec.
English: If you take more Vedrop than you should
Croatian: Ako uzmete više Vedropa nego što ste trebali
English: In case of overdose, a symptomatic treatment should be proposed.
Croatian: U slučaju predoziranja, treba predložiti simptomatsku terapiju.
English: • Loss of hair
Croatian: • Gubitak kose
English: What Vedrop is and what it is used for
Croatian: Što je Vedrop i za što se koristi
English: Talk to your doctor or pharmacist if symptoms persist more than two days.
Croatian: Razgovarajte sa svojim liječnikom ili ljekarnikom ako simptomi potraju duže od dva dana.
English: This medicine has been authorised under “exceptional circumstances”.
Croatian: Ovaj lijek je odobren u ‘iznimnim okolnostima'.
English: 1- Open the bottle.
Croatian: 1- Otvorite bocu.
English: Frequencies are defined as: 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: Učestalost je definirana kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Non-clinical data in the literature reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity and toxicity to reproduction.
Croatian: Neklinički podaci iz literature nisu pokazali posebnu opasnost za ljude na temelju konvencionalnih studija toksičnosti ponavljanih doza, genotoksičnosti i reproduktivne toksičnosti.
English: 6- Close the bottle.
Croatian: 6- Zatvorite bocu.
English: Do not stop the treatment without consulting your doctor because lack of vitamin E may come back and affect your health.
Croatian: Nemojte prekinuti liječenje prije nego se posavjetujete sa svojim liječnikom jer se nedostatak vitamina E može vratiti i utjecati na Vaše zdravlje.
English: Vitamin E is the principal lipo-soluble antioxidant in the organism.
Croatian: Vitamin E je glavni liposolubilni antioksidans u organizmu.
English: To measure the dose:
Croatian: Kako biste odmjerili dozu:
English: Your doctor will ask you to perform blood tests regularly and may adjust their dose to avoid higher risk of bleeding.
Croatian: Liječnik će tražiti da redovito obavljate krvne pretrage te može prilagoditi njihovu dozu da bi se izbjegao veći rizik od krvarenja.
English: You can take Vedrop before or during your meal, with or without water.
Croatian: Vedrop možete uzeti prije ili tijekom svog obroka, s vodom ili bez nje.
English: • Increase of transaminases (liver enzymes)
Croatian: • Povišene transaminaze (jetreni enzimi)
English: 5- Empty the contents of the syringe by pushing the plunger to the bottom either: - directly into the mouth, or - into a glass of water and then drink the entire content of the glass.
Croatian: 5- Pritiskom na potisnik do kraja ispraznite sadržaj štrcaljke bilo: - izravno u usta, ili - u čašu vode te zatim popijte čitav sadržaj čaše.
English: • Discard the bottle one month after first opening, even if some solution remains.
Croatian: • Odbacite bocu mjesec dana nakon prvog otvaranja, čak i ako preostane nešto otopine.
English: Problems with your liver.
Croatian: Problema s jetrom.
English: The excretion of tocofersolan in milk has not been studied in animals.
Croatian: Izlučivanje tokofersolana u mlijeko nije proučavano na životinjama.
English: Certain medicines to thin the blood (oral anticoagulants such as warfarin).
Croatian: Određene lijekove za razrjeđenje krvi (oralne antikoagulanse poput varfarina).
English: What Vedrop looks like and contents of the pack
Croatian: Kako Vedrop izgleda i sadržaj pakovanja
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na trudnoću, embrionalni/fetalni razvoj, porod ili postnatalni razvoj (vidjeti dio 5.3).
English: The result is the volume of Vedrop in ml:
Croatian: Rezultat je volumen Vedropa u ml:
English: There is no data on whether or not this medicine is present in the breast milk.
Croatian: Nema podataka o tome je li ovaj lijek prisutan u majčinom mlijeku.
English: Its critical micellar concentration is low (0.04 to 0.06 mmol/l).
Croatian: Njegova kritična micelarna koncentracija je niska (0.04 do 0.06 mmol/l).
English: Summary of the safety profile The most commonly reported adverse reaction during treatment is diarrhoea.
Croatian: Sažetak sigurnosnog profila Najčešće prijavljena nuspojava tijekom liječenja je proljev.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 July 2009
Croatian: Datum prvog odobrenja: 24. srpnja 2009.
English: Bioavailability of vitamin E from Vedrop differs from that of other medicinal products.
Croatian: Bioraspoloživost vitamina E iz Vedropa razlikuje se od one drugih lijekova.
English: No clinical data are available on exposure to this medicine during pregnancy.
Croatian: Nema kliničkih podataka o izloženosti ovom lijeku tijekom trudnoće.
English: What you need to know before you take Vedrop
Croatian: Što morate znati prije nego počnete uzimati Vedrop
English: Problems with your kidney or dehydration.
Croatian: Problema s bubrezima ili dehidracijom.
English: Do not take Vedrop - If you are allergic to vitamin E (d-alpha-tocopherol) or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Vedrop - Ako ste alergični na vitamin E (d-alfa-tokoferol) ili na bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: The usual dose is 0.34 ml/kg/day.
Croatian: Uobičajena doza je 0,34 ml/kg/dan.
English: A possible adjustment of the dose of oral anticoagulant during and after treatment with Vedrop may be necessary.
Croatian: Može biti potrebna prilagodba doze oralnog antikoagulansa tijekom i nakon liječenja Vedropom.
English: 3-Fill the oral syringe with the liquid by pulling the plunger up to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor.
Croatian: 3-Ispunite oralnu štrcaljku tekućinom povlačeći potisnik do mjerne oznake koja odgovara količini u mililitrima (ml) propisanoj od strane Vašeg liječnika.
English: As Vedrop may increase their absorption during digestion, your doctor will monitor the treatment effect and adjust the doses if necessary.
Croatian: S obzirom da Vedrop može povećati njihovu apsorpciju tijekom probave, liječnik će pratiti terapijski učinak i po potrebi prilagoditi dozu.
English: Your doctor will prescribe the dose in ml.
Croatian: Vaš liječnik će propisati dozu u ml.
English: Not known (frequency cannot be estimated from the available data) • Stomach ache
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) • tupa bol u trbuhu
English: 4- Remove the oral syringe from the bottle.
Croatian: 4- Maknite oralnu štrcaljku iz boce.
English: The following side effects were reported:
Croatian: Zabilježene su sljedeće nuspojave:
English: Skip the missed dose and go back to the regular dosing schedule.
Croatian: Preskočite propuštenu dozu te se vratite na redoviti raspored uzimanja lijeka.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Vedrop should be made taking into account the benefit of breast-feeding to the child and the benefit of tocofersolan therapy to the woman.
Croatian: Potrebno je odlučiti da li nastaviti/prekinuti dojenje ili nastaviti/prekinuti liječenje lijekom Vedropom uzimajući u obzir korist dojenja za dijete i korist liječenja tokofersolanom za ženu.
English: Yearly, simultaneously with submission of Periodic Safety Update reports
Croatian: Godišnje, istovremeno s podnošenjem periodičkih izvješća o neškodljivosti
English: It acts as a free radical chain breaking molecule, stopping the peroxidation of polyunsaturated fatty acids and it is involved in maintaining the stability and integrity of cell membranes.
Croatian: Djeluje kao molekula koja razbija lanac slobodnih radikala, zaustavljajući peroksidaciju polinezasićenih masnih kiselina te je uključen u održavanje stabilnosti i cjelovitosti staničnih membrana.
English: Inform your doctor if you are pregnant as he/she will decide if the medicine may be used.
Croatian: Obavijestite svog liječnika ukoliko ste trudni jer će on odlučiti možete li koristiti ovaj lijek.
English: Pharmacotherapeutic group: Vitamins, Other plain vitamin preparations; ATC code: A11HA08
Croatian: Farmakoterapijska skupina: Vitamini, ostali pripravci pojedinačnih vitamina, ATK oznaka: A11HA08
English: Caution should be exercised when prescribing to pregnant women.
Croatian: Treba biti oprezan prilikom primjene kod trudnica.
English: Therefore, monitoring should be performed and, when necessary, doses should be adjusted.
Croatian: Stoga je nužno praćenje te, po potrebi, prilagodba doze.
English: 7- Wash the syringe with water.
Croatian: 7- Isperite štrcaljku vodom.
English: Vedrop is administered orally with or without water.
Croatian: Vedrop se primjenjuje peroralno sa ili bez vode.
English: Vedrop should be used with caution and your kidney function closely monitored, because polyethylene glycol, part of the active substance tocofersolan, may damage your kidneys.
Croatian: Vedrop treba primijeniti s oprezom te pažljivo pratiti Vašu bubrežnu funkciju, jer polietilenglikol, dio djelatne tvari tokofersolana, može oštetiti bubrege.
English: Vitamin E is mainly eliminated in the bile (75%) and stools, either as free tocopherol or as oxidized forms.
Croatian: Vitamin E se većinom eliminira putem žuči (75%) i stolice, kao slobodni tokoferol ili u oksidiranim oblicima.
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Croatian: POSEBNE OBVEZE ZA ISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
English: CONDITIONS OR RESTRICTIONS REGARDING THE SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane redom od ozbiljnije prema manje ozbiljnoj.
English: The dose should be prescribed in ml.
Croatian: Dozu treba propisati u ml.
English: Common side effects (may affect up to 1 in 10 people)
Croatian: Česte nuspojave (mogu zahvatiti do 1 na 10 osoba)
English: Plasma vitamin E level should be monitored monthly for at least the first few months of therapy, thereafter at regular intervals and the dose adjusted accordingly if necessary.
Croatian: Razinu vitamina E u plazmi treba mjeriti jednom mjesečno, barem nekoliko prvih mjeseci liječenja, a nakon toga u pravilnim razmacima te po potrebi prema njoj prilagoditi dozu.
English: Tell your doctor or pharmacist if you are taking:
Croatian: Obavijestite svog liječnika ili ljekarnika ukoliko uzimate:
English: The relative bioavailability of tocofersolan tended to be higher (Frel of 1.01 ± 1.74) with AUC0-t of 0.383 ± 0.203µM.h/mg, Cmax of 0.013 ± 0.006, tmax of 6.0 h (6.0 - 24.0), and t1/2 of 29.7 h (16.0 - 59.5).
Croatian: Relativna bioraspoloživost tokofersolana naginjala je višim vrijednostima (Frel 1.01 ± 1.74) s AUC0-t 0.383 ± 0.203 µM.h/mg, Cmax 0.013 ± 0.006, tmax 6.0 h (6.0 - 24.0), te t1/2 29.7 h (16.0 - 59.5).
English: • Do not use this medicine after the expiry date which is stated on the box and the bottle, after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci, iza „Rok valjanosti“.
English: Doses for administration should be extracted from the bottle using the oral syringes which are provided in the pack.
Croatian: Doze za primjenu treba izvlačiti iz boce koristeći oralne štrcaljke koje su priložene u pakovanju.
English: Speak to your doctor if you are on a controlled sodium diet.
Croatian: Razgovarajte sa svojim liječnikom ako ste na dijeti s ograničenim unosom natrija.
English: • Abnormal level of sodium in the blood
Croatian: • Abnormalna razina natrija u krvi
English: Fertility No data is available
Croatian: Plodnost Nema dostupnih podataka.
English: A study in 12 healthy volunteers compared tocofersolan with a water-miscible reference vitamin E after a single oral loading dose of 1200 IU.
Croatian: Studija na 12 zdravih dobrovoljaca uspoređivala je tokofersolan s referentnim vitaminom E pomiješanim s vodom nakon jedne oralne udarne doze od 1200 IU.
English: The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Croatian: Europska agencija za lijekove će svake godine procjenjivati nove informacije o ovom lijeku te će se ova uputa obnavljati prema potrebi.
English: • Abnormal level of potassium in the blood
Croatian: • Abnormalna razina kalija u krvi
English: The 1-ml or 2-ml oral syringes included in the container are designed to assist in measuring out the exact dose in accordance with the prescribed posology.
Croatian: Oralne štrcaljke od 1 ml ili 2 ml uključene u pakovanje namijenjene su pomoći pri točnom odmjeravanju doze u skladu s propisanim doziranjem.
English: If you stop taking Vedrop
Croatian: Ako prestanete uzimati Vedrop
English: • Asthenia (feeling of weakness)
Croatian: • Astenija (osjećaj slabosti)
English: Other medicines and Vedrop Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Croatian: Budući je ovo odobrenje u iznimnim okolnostima, a temeljem članka 14(8) Uredbe (EZ) br. 726/2004, nositelj odobrenja će, unutar navedenog vremenskog okvira, provoditi sljedeće mjere:
English: Located principally on cell membranes, within mitochondria and microsomes, vitamin E is ubiquitously distributed (red blood cells, brain, muscle, liver, platelets) and fat tissues are its major reservoir.
Croatian: Lokaliziran prvenstveno na staničnim membranama, unutar mitohondrija i mikrosoma, vitamin E je svugdje ravnomjerno raspoređen (u crvenim krvnim stanicama, mozgu, mišićima, jetri, trombocitima), a masno tkivo je njegov glavni rezervoar.
English: At low concentrations, tocofersolan forms micelles which enhance absorption of non-polar lipids such as fat-soluble vitamins.
Croatian: U niskim koncentracijama, tokofersolan formira micele koje poboljšavaju apsorpciju nepolarnih lipida poput vitamina topljivih u mastima.
English: Vedrop has no or negligible influence on the ability to drive and use machines.
Croatian: Vedrop ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Vedrop must not be used in preterm newborn infants.
Croatian: Vedrop se ne smije koristiti kod prijevremeno rođene dojenčadi.
English: The recommended total daily dose in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis is 0.34 ml/kg/day (17 mg/kg of d-alpha-tocopherol in the form of tocofersolan).
Croatian: Preporučena ukupna dnevna doza kod pedijatrijskih bolesnika koji imaju kongenitalnu kroničnu kolestazu ili hereditarnu kroničnu kolestazu je 0,34 ml/kg/dan (17 mg/kg d-alfa-tokoferola u obliku tokofersolana).
English: Absorption of deuterated tocofersolan showed a normal pattern in lipoproteins: alphatocopherol peaked first in chylomicrons, then in very low- density lipoproteins (VLDL) and finally in lowdensity lipoproteins (LDL) and high-density lipoproteins (HDL), and the disappearance portions of the curves paralleled those in control subjects.
Croatian: Apsorpcija tokofersolana obilježenog deuterijem pokazala je normalan obrazac u lipoproteinima: alfa-tokoferol prvo je postigao vršnu koncentraciju u hilomikronima, zatim u lipoproteinima vrlo niske gustoće (VLDL) te konačno u lipoproteinima niske gustoće (LDL) i lipoproteinima visoke gustoće (HDL), a završni dijelovi krivulja bili su paralelni onima kod kontrolnih ispitanika.
English: Uncommon side effects (may affect up to 1 in 100 people)
Croatian: Manje česte nuspojave (mogu zahvatiti do 1 na 100 osoba)