natgillin/translations-raw huggingface dataset:
Inform your doctor if you are pregnant as he/she will decide if the medicine may be used.
Obavijestite svog liječnika ukoliko ste trudni jer će on odlučiti možete li koristiti ovaj lijek.
Pharmacotherapeutic group: Vitamins, Other plain vitamin preparations; ATC code: A11HA08
Farmakoterapijska skupina: Vitamini, ostali pripravci pojedinačnih vitamina, ATK oznaka: A11HA08
Caution should be exercised when prescribing to pregnant women.
Treba biti oprezan prilikom primjene kod trudnica.
Therefore, monitoring should be performed and, when necessary, doses should be adjusted.
Stoga je nužno praćenje te, po potrebi, prilagodba doze.
7- Wash the syringe with water.
7- Isperite štrcaljku vodom.
Vedrop is administered orally with or without water.
Vedrop se primjenjuje peroralno sa ili bez vode.
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.
Vedrop treba primijeniti s oprezom te pažljivo pratiti Vašu bubrežnu funkciju, jer polietilenglikol, dio djelatne tvari tokofersolana, može oštetiti bubrege.
Vitamin E is mainly eliminated in the bile (75%) and stools, either as free tocopherol or as oxidized forms.
Vitamin E se većinom eliminira putem žuči (75%) i stolice, kao slobodni tokoferol ili u oksidiranim oblicima.
SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
POSEBNE OBVEZE ZA ISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
CONDITIONS OR RESTRICTIONS REGARDING THE SUPPLY AND USE
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Unutar svake skupine učestalosti, nuspojave su prikazane redom od ozbiljnije prema manje ozbiljnoj.
The dose should be prescribed in ml.
Dozu treba propisati u ml.
Common side effects (may affect up to 1 in 10 people)
Česte nuspojave (mogu zahvatiti do 1 na 10 osoba)
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.
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.
Tell your doctor or pharmacist if you are taking:
Obavijestite svog liječnika ili ljekarnika ukoliko uzimate:
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).
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).
• Do not use this medicine after the expiry date which is stated on the box and the bottle, after EXP.
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci, iza „Rok valjanosti“.
Doses for administration should be extracted from the bottle using the oral syringes which are provided in the pack.
Doze za primjenu treba izvlačiti iz boce koristeći oralne štrcaljke koje su priložene u pakovanju.
Speak to your doctor if you are on a controlled sodium diet.
Razgovarajte sa svojim liječnikom ako ste na dijeti s ograničenim unosom natrija.
• Abnormal level of sodium in the blood
• Abnormalna razina natrija u krvi
Fertility No data is available
Plodnost Nema dostupnih podataka.
A study in 12 healthy volunteers compared tocofersolan with a water-miscible reference vitamin E after a single oral loading dose of 1200 IU.
Studija na 12 zdravih dobrovoljaca uspoređivala je tokofersolan s referentnim vitaminom E pomiješanim s vodom nakon jedne oralne udarne doze od 1200 IU.
The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Europska agencija za lijekove će svake godine procjenjivati nove informacije o ovom lijeku te će se ova uputa obnavljati prema potrebi.
• Abnormal level of potassium in the blood
• Abnormalna razina kalija u krvi
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.
Oralne štrcaljke od 1 ml ili 2 ml uključene u pakovanje namijenjene su pomoći pri točnom odmjeravanju doze u skladu s propisanim doziranjem.
If you stop taking Vedrop
Ako prestanete uzimati Vedrop
• Asthenia (feeling of weakness)
• Astenija (osjećaj slabosti)
Other medicines and Vedrop Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
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:
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:
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.
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.
At low concentrations, tocofersolan forms micelles which enhance absorption of non-polar lipids such as fat-soluble vitamins.
U niskim koncentracijama, tokofersolan formira micele koje poboljšavaju apsorpciju nepolarnih lipida poput vitamina topljivih u mastima.
Vedrop has no or negligible influence on the ability to drive and use machines.
Vedrop ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Vedrop must not be used in preterm newborn infants.
Vedrop se ne smije koristiti kod prijevremeno rođene dojenčadi.
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).
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).
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.
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.
Uncommon side effects (may affect up to 1 in 100 people)
Manje česte nuspojave (mogu zahvatiti do 1 na 100 osoba)
Experience with tocofersolan therapy in patients with renal impairment or underlying liver impairment has demonstrated no need to adapt the dose regimen of Vedrop (see section 4.4).
Iskustvo s terapijom tokofersolanom u bolesnika s oštećenjem bubrega ili postojećim oštećenjem jetre ukazalo je da nije potrebno prilagođavati režim doziranja lijeka Vedrop (vidjeti dio 4.4).
What Vedrop is and what it is used for What you need to know before you take Vedrop How to take Vedrop
Što je Vedrop i za što se koristi Što morate znati prije nego počnete uzimati Vedrop Kako uzimati Vedrop
- Vedrop must not be used in newborn premature babies.
- Vedrop se ne smije primjenjivati u prerano rođene novorođenčadi.
In a similar study tocofersolan showed a higher bioavailability than a water-miscible reference vitamin E in paediatric patients with chronic cholestasis (n=6), absorption was significantly higher on both plasma concentration maximum increase (p=0.008) and AUC (p=0.0026).
U sličnoj studiji na pedijatrijskim bolesnicima s kroničnom kolestazom (n=6) tokofersolan je pokazao veću bioraspoloživost od referentnog vitamina E pomiješanog s vodom, apsorpcija je bila značajno viša s porastom maksimalne koncentracije u plazmi (p=0.008) i AUC (p=0.0026).
It is recommended to monitor the coagulation function when administered with anti-vitamins K treatment (see section 4.4).
Preporučuje se praćenje funkcije koagulacije kad se lijek primjenjuje uz terapiju antagonistima vitamina K (vidjeti dio 4.4).
Due to inhibition of P-Glycoprotein transporter, tocofersolan may also enhance intestinal absorption of other concomitant fat-soluble vitamins (A, D, E, K) or that of highly lipophilic medicinal products (such as steroids, antibiotics, antihistamines, cyclosporine, tacrolimus).
Zbog inhibicije P-glikoproteinskog transportera, tokofersolan može također povećati crijevnu apsorpciju drugih vitamina topljivih u mastima (A, D, E, K) ili visoko lipofilnih lijekova (poput steroida, antibiotika, antihistaminika, ciklosporina, takrolimusa).
Talk to your doctor before taking Vedrop if you have:
Obavijestite svog liječnika prije uzimanja lijeka Vedrop ukoliko imate:
The MAH shall provide yearly updates on any new information concerning efficacy and safety of the product in patients with congenital chronic cholestasis or hereditary cholestasis.
Nositelj odobrenja će godišnje priložiti nadopune u vezi s bilo kakvim novim informacijama o učinkovitosti i neškodljivosti lijeka kod pacijenata s kongenitalnom kroničnom kolestazom ili hereditarnom kolestazom.
It is used to treat lack of vitamin E due to digestive malabsorption (where nutrients from the food are not easily absorbed during digestion) in patients from birth (full term newborns) up to 18 years of age suffering from chronic cholestasis (a hereditary or congenital disease where bile cannot flow from the liver to the intestine).
Koristi se za liječenje nedostatka vitamina E uzrokovanog probavnom malapsorpcijom (kada se hranjive tvari iz hrane ne apsorbiraju lako tijekom probave) u bolesnika od rođenja (novorođenčad rođena u terminu) do 18. godine života koji boluju od kronične kolestaze (nasljedne ili prirođene bolesti u kojoj žuč ne može teći iz jetre u crijeva).
• Rash (eruption on the skin)
• Osip (izbijanje promjena na koži)
Inform your doctor if you want to breast-feed.
Obavijestite svog liječnika ukoliko želite dojiti.
The dose should be adjusted according to plasma vitamin E level.
Dozu treba prilagoditi prema razini vitamina E u plazmi.
Urine represents a minor elimination route of vitamin E (as glucuro-conjugate).
Mokraća predstavlja minoran put eliminacije vitamina E (u obliku glukokonjugata).
The hydrolysis of tocofersolan occurs in the gut lumen.
Hidroliza tokofersolana događa se u lumenu crijeva.
Vedrop contains vitamin E (in the form of tocofersolan).
Vedrop sadrži vitamin E (u obliku tokofersolana).
It is unknown whether tocofersolan is excreted in human breast milk.
Nije poznato izlučuje li se tokofersolan izlučuje u majčino mlijeko u ljudi.
Vedrop contains 0.18 mmoles (4.1 mg) sodium per ml.
Vedrop sadrži 0,18 mmol (4,1 mg) natrija po mililitru (ml).
If you take large doses of Vitamin E, you may experience temporary diarrhoea and stomach ache.
Ukoliko uzmete visoke doze vitamina E, možete dobiti prolazni proljev ili tupe bolove u trbuhu.
The active substance d-alpha-tocopherol-polyethylene glycol 1000 succinate (tocofersolan) is a pro-drug; the active metabolite is the d-alpha-tocopherol.
Djelatna tvar d-alfa-tokoferol-polietilenglikol 1000 sukcinat (tokofersolan) je predlijek; aktivni metabolit je d-alfa-tokoferol.
Vedrop is indicated in vitamin E deficiency due to digestive malabsorption in paediatric patients with congenital chronic cholestasis or hereditary chronic cholestasis, from birth (full term newborns) up to 18 years of age.
Vedrop je indiciran kod deficijencije vitamina E zbog probavne malapsorpcije u pedijatrijskih bolesnika s kongenitalnom kroničnom kolestazom ili hereditarnom kroničnom kolestazom, od rođenja (terminska novorođenčad) do 18 godina starosti.
The treatment with Vedrop should be initiated and supervised by a physician experienced in the management of patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis.
Liječenje Vedropom treba započeti i nadgledati liječnik s iskustvom u liječenju bolesnika koji imaju kongenitalnu kroničnu kolestazu ili hereditarnu kroničnu kolestazu.
• Keep this medicine out of the sight and reach of children.
• Ovaj lijek čuvajtepogleda i dohvata djece.
The 1 ml oral syringe is graduated from 0.05 to 1 ml in steps of 0.05 ml.
Oralna štrcaljka od 1 ml je graduirana od 0,05 do 1 ml u razmacima od 0,05 ml.
The 2 ml oral syringe is graduated from 0.1 to 2 ml in steps of 0.1 ml.
Oralna štrcaljka od 2 ml je graduirana od 0,1 do 2 ml u razmacima od 0,1 ml.
Swallow the solution with or without water.
Progutatajte otopinu sa ili bez vode.
BATCH NUMBER EU/1/09/533/001 10 ml bottle EU/1/09/533/00 2 20 ml bottle EU/1/09/533/003 60 ml bottle
EU/1/09/533/001 boca od 10 ml EU/1/09/533/002 boca od 20 ml EU/1/09/533/003 boca od 60 ml
EXP Discard one month after first opening.
Rok valjanosti Lijek odbacite mjesec dana od prvog otvaranja.
Fat-soluble vitamins (such as vitamin A, D, E or K) or highly fat-soluble medicines (such as corticoids, ciclosporin, tacrolimus, antihistamine).
Vitamine topive u mastima (poput vitamina A, D, E ili K) ili lijekove koji su dobro topivi u mastima (poput kortikosteroida, ciklosporina, takrolimusa, antihistaminika).
Use only with the oral syringe provided in the box.
Primjenjujte ju samo uz pomoć oralne štrcaljke koja se nalazi u kutiji.
If you forget to take Vedrop
Ako ste zaboravili uzeti Vedrop
To calculate the dose of Vedrop to be administered, divide the prescribed dose of d-alpha-tocopherol (in mg) by 50.
Da biste izračunali dozu Vedropa koju treba primijeniti, podijelite propisanu dozu d-alfa-tokoferola (u mg) s 50.
Reported adverse reactions are listed below, by system organ class and by frequency.
Zabilježene nuspojave su navedene niže, prema organskom sustavu i učestalosti.
As data on patients with renal impairment are limited, Vedrop should be administered with caution and under close monitoring of the renal function in patients with renal impairment e.g. dehydrated patients (see section 4.2).
S obzirom da su podaci kod bolesnika s oštećenjem bubrega ograničeni, Vedrop treba primjenjivati s oprezom te uz pažljivo praćenje bubrežne funkcije kod bolesnika s poremećajem rada bubrega, npr. dehidriranih bolesnika (vidjeti dio 4.2).
It should be taken into consideration by patients on a controlled sodium diet.
To treba uzeti u obzir kod bolesnika na dijeti s ograničenim unosom natrija.
Each ml contains 6 mg sodium methyl parahydroxybenzoate (E219), 4 mg sodium ethyl parahydroxybenzoate (E215) and 0.18 mmoles (4.1 mg) of sodium.
Svaki ml sadrži 6 mg natrijeva metilparahidroksibenzoata (E219), 4 mg natrijeva etilparahidroksibenzoata (E215) i 0,18 mmol (4,1 mg) natrija.
What Vedrop contains - The active substance is tocofersolan.
Što Vedrop sadrži - Djelatna tvar je tokofersolan.
- The other ingredients are: potassium sorbate, sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) (see end of section 2 for further information on these 2 ingredients), glycerol, disodium phosphate dodecahydrate, concentrated hydrochloric acid, purified water.
- Drugi sastojci su: kalijev sorbat, natrijev metilparahidroksibenzoat (E219), natrijev etilparahidroksibenzoat (E215) (pogledajte kraj dijela 2 za više informacija o ova dva sastojka), glicerol, natrijev hidrogenfosfat dodekahidrat, koncentrirana klorovodična kiselina, pročišćena voda.
The following table gives the volume of oral solution in function of patients' weights.
Sljedeća tablica prikazuje volumen oralne otopine s obzirom na bolesnikovu tjelesnu težinu.
Vedrop should be used with caution and liver functions closely monitored.
Vedrop treba primijeniti s oprezom te pažljivo pratiti jetrenu funkciju.
Oral syringes with housing of LDPE and piston of polystyrol.
Oralne štrcaljke s kućištem od LDPE i klipom od polistirola.
Oral solution volume (ml)
Volumen oralne otopine (ml)
Each box contains one bottle and one oral syringe (a 1 ml syringe with a 10 ml or 20 ml bottle, a 2 ml syringe with a 60 ml bottle).
Svaka kutija sadrži jednu bocu i jednu oralnu štrcaljku (štrcaljku od 1 ml uz boce od 10 ml ili 20 ml, štrcaljku od 2 ml uz bocu od 60 ml).
Type III brown glass bottle with a child-resistant screw cap of HDPE and LDPE seal.
Smeđa staklena boca tipa III sa zaštitnim navojnim poklopcem HDPE za djecu i zatvaračem LDPE.
Dose of Vedrop (in ml) = dose of d-alpha-tocopherol (in mg)
Doza Vedropa (u ml) = doza d-alfa-tokoferola (u mg)
The dose should be prescribed in mg of d-alpha-tocopherol in the form of tocofersolan.
Dozu treba propisati u mg d-alfa-tokoferola u obliku tokofersolana.
See the package leaflet for further information.
Pogledajte Uputu o lijeku za dodatne informacije.
The dose will be adjusted by your doctor according to your vitamin E blood level.
Liječnik će prilagoditi dozu prema razini vitamina E u Vašoj krvi.
Uncommon: asthenia, headache
Manje često: astenija, glavobolja
For tocofersolan no clinical data on exposed pregnancies are available.
Nisu dostupni klinički podaci o utjecaju tokofersolana na trudnoću.
Vedrop 50 mg/ml oral solution Tocofersolan
Vedrop 50 mg/ml oralna otopina tokofersolan
As large doses of vitamin E have been reported to increase bleeding tendency in vitamin-K deficient patients or those taking oral anti-vitamins K treatment, it is therefore recommended to monitor the prothrombin time and international normalised ratio (INR).
K ili onih liječenih oralnim antagonistima vitamina K, preporučuje se praćenje protrombinskog vremena te internacionalnog normaliziranog omjera (INR).
Driving and using machines Vedrop is not likely to affect your ability to drive and use machines.
Nije vjerojatno da će Vedrop utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
Not known: abdominal pain
Često: proljev Nepoznato: bol u trbuhu
2- Put the oral syringe included in the pack in the bottle.
2- Umetnite u bocu oralnu štrcaljku koja se nalazi u pakovanju.
Each bottle contains 10 ml, 20 ml or 60 ml of oral solution.
Svaka boca sadrži 10 ml, 20 ml ili 60 ml otopine za oralnu primjenu.
Uncommon: serum sodium abnormal, serum potassium abnormal, transaminases increase
Manje često: poremećaj natrija u serumu, poremećaj kalija u serumu, povišene transaminaze
Vedrop should be administered with caution in patients with underlying liver impairment and under close monitoring of the hepatic functions in such patients (see section 4.2).
Vedrop treba kod bolesnika s postojećim oštećenjem jetre primjenjivati s oprezom i uz pažljivo praćenje jetrene funkcije (vidjeti dio 4.2).
Large vitamin E doses may cause diarrhoea, abdominal pain, and other gastrointestinal disturbances.
Visoke doze vitamina E mogu dovesti do proljeva, bolova u trbuhu te drugih probavnih tegoba.
Excipients: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215).
Pomoćne tvari: natrijev metilparahidroksibenzoat (E219), natrijev etilparahidroksibenzoat (E215).
How to take Vedrop
Kako uzimati vedrop
Bottle of 60 ml and 2 ml oral syringe.
Boca od 60 ml i oralna štrcaljka od 2 ml.
Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215), which may cause allergic reactions (possibly delayed).
Vedrop sadrži metilparahidroksibenzoat (E219) i natrijev etilparahidroksibenzoat (E215), koji mogu dovesti do alergijskih reakcija (koje mogu biti odgođene).
One graduation of the 1 ml oral syringe corresponds to 2.5 mg of d-alpha-tocopherol in the form of tocofersolan.
Jedan razmak na oralnoj štrcaljki od 1 ml odgovara 2,5 mg d-alfa-tokoferola u obliku tokofersolana.
How to store Vedrop
Kako čuvati Vedrop
Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) which may cause allergic reactions (possibly delayed).
Vedrop sadrži natrijev metilparahidroksibenzoat (E219) te natrijev etilparahidroksibenzoat (E215) koji mogu uzrokovati alergijske reakcije (koje mogu biti odgođene).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle label - 10 ml, 20 ml and 60 ml bottles
Naljepnica na boci - boce od 10 ml, 20 ml i 60 ml
Boxes containing: one 10 ml bottle and one 1 ml oral syringe one 20 ml bottle and one 1 ml oral syringe one 60 ml and one 2 ml oral syringe
jednu bocu od 10 ml te jednu oralnu štrcaljku od 1 ml jednu bocu od 20 ml te jednu oralnu štrcaljku od 1 ml jednu bocu od 60 ml te jednu oralnu štrcaljku od 2 ml
One graduation of the 2-ml oral syringe corresponds to 5 mg of d-alpha-tocopherol in the form of tocofersolan.
Jedan razmak na oralnoj štrcaljki od 2 ml odgovara 5 mg d-alfa-tokoferola u obliku tokofersolana.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na poseban i ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio
Bottle of 20 ml and 1 ml oral syringe.
Boca od 20 ml i oralna štrcaljka od 1 ml.
Bottle of 10 ml and 1 ml oral syringe.
Boca od 10 ml i oralna štrcaljka od 1 ml.
INFORMATION IN BRAILLE Vedrop 50 mg/ml UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton box - 10 ml, 20 ml and 60 ml bottle
Kartonska kutija - boca od 10 ml, 20 ml i 60 ml
Taken up by cells, the alpha-tocopherol moiety appears in chylomicrons in the lymph in a manner identical to vitamin E absorbed from the diet. Cellular uptake does not require receptors, binding proteins or metabolic processes and does not occur by pinocytosis.
Unos u stanicu ne zahtijeva receptore, vezne proteine ili metaboličke procese te se ne događa putem pinocitoze.
Each ml contains 50 mg of d-alpha-tocopherol, in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.
Svaki ml sadrži 50 mg d-alfa-tokoferola, u obliku tokofersolana, što odgovara 74.5 IU tokoferola.
Each ml contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.
Svaki ml sadrži 50 mg d-alfa-tokoferola u obliku tokofersolana, što odgovara 74.5 IU tokoferola.
Each ml of solution contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.
Svaki ml otopine sadrži 50 mg d-alfa-tokoferola u obliku tokofersolana, što odgovara 74,5 IU tokoferola.
Vedrop is a slightly viscous pale yellow oral solution in a brown glass bottle which is closed with a childresistant cap.
Vedrop je blago viskozna blijedožuta oralna otopina u smeđoj staklenoj boci koja je zatvorena zaštitnim poklopcem za djecu.Boce sadrže 10 ml, 20 ml ili 60 ml oralne otopine.
Skin and subcutaneous tissue disorders Uncommon: alopecia, pruritus, rash General disorders and administration site conditions
Manje često: alopecija, svrbež, osip
Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215) Glycerol
6.1 Popis pomoćnih tvari kalijev sorbat natrijev metilparahidroksibenzoat (E219) natrijev etilparahidroksibenzoat (E215) glicerol natrijev hidrogenfosfat dodekahidrat kloridna kiselina, koncentrirana pročišćena voda
If you get any side effects, talk to your doctor or pharmacist.
Prije prekida terapije lijekom Vedrop obratite se svom liječniku ili ljekarniku.
• Itching
• Proljev
Slightly viscous, pale yellow solution.
Blago viskozna, blijedožuta otopina.