FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/98/096/001 (5 hard capsules) EU/1/98/096/002 (20 hard capsules)
Slovenian: EU/1/98/096/001 (5 trdih kapsul) EU/1/98/096/002 (20 trdih kapsul)
English: Male fertility
Slovenian: Raven odmerka
English: The first dose will be 150 mg/m2.
Slovenian: Stopnje odmerka so 100 mg/m 150 mg/m 2 in 200 mg/m 2.
English: Your doctor will help you decide what is best for you and your child.
Slovenian: Vaš zdravnik vam bo pomagal sprejeti odločitev o tem, kaj je najbolje za vas in vašega otroka.
English: After first opening the bottle: 1 month.
Slovenian: Po prvem odprtju steklenice: 1 mesec.
English: Problems with your liver.
Slovenian: Težave z jetri.
English: In case of overdose, a symptomatic treatment should be proposed.
Slovenian: V primeru prevelikega odmerjanja je potrebno predlagati simptomatsko zdravljenje.
English: EXP Discard one month after first opening.
Slovenian: EXP Zavrzite en mesec po prvem odprtju.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Slovenian: Če datumi za predložitev PSUR in posodobitev RMP sovpadata, se ju lahko predloži istočasno.
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).
Slovenian: Pogostost je definirana na naslednji način: zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10), občasno (≥ 1/1,000 do < 1/100), redko (≥ 1/10,000 do < 1/1,000), zelo redko (< 1/10,000), ni znano (ni mogoče oceniti s pomočjo razpoložljivih podatkov).
English: Your doctor will ask you to perform blood tests regularly and may adjust their dose to avoid higher risk of bleeding.
Slovenian: Vaš zdravnik vas bo prosil, da redno hodite na preglede krvi in lahko prilagodi odmerek, da se izognete večji nevarnosti krvavitev.
English: What Vedrop is and what it is used for
Slovenian: Kaj je zdravilo Vedrop in za kaj se uporablja
English: • Discard the bottle one month after first opening, even if some solution remains.
Slovenian: • Steklenico zavrzite en mesec po prvem odprtju, tudi če je ostalo še nekaj raztopine.
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.
Slovenian: Neklinični podatki v literaturi ne razkrivajo posebnih nevarnosti za ljudi na podlagi konvencionalnih študij o toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in toksičnem vplivu na sposobnost razmnoževanja.
English: Talk to your doctor or pharmacist if symptoms persist more than two days.
Slovenian: Posvetujte se s zdravnikom ali farmacevtom, če so simptomi po več kot dveh dneh še vedno prisotni.
English: Vitamin E is the principal lipo-soluble antioxidant in the organism.
Slovenian: E vitamin je osnovni lipo-raztopljiv antioksidant v organizmu.
English: Summary of the safety profile The most commonly reported adverse reaction during treatment is diarrhoea.
Slovenian: Povzetek varnostnega profila Najbolj pogost zabeležen neželen učinek med zdravljenjem je diareja.
English: Not known (frequency cannot be estimated from the available data) • Stomach ache
Slovenian: Neznana (pogostosti iz razpoložljivih podatkov ni mogoče oceniti) • bolečine v trebuhu
English: • Increase of transaminases (liver enzymes)
Slovenian: • povečanje transaminaz (encimi jeter)
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.
Slovenian: Nivo vitamina E v plazmi je treba preverjati mesečno vsaj v prvih nekaj mesecih terapije in nato v rednih intervalih ter odmerek po potrebi primerno prilagoditi.
English: Its critical micellar concentration is low (0.04 to 0.06 mmol/l).
Slovenian: Njegova kritična micelarna koncentracija je nizka (0,04 do 0,06 mmol/l).
English: Do not stop the treatment without consulting your doctor because lack of vitamin E may come back and affect your health.
Slovenian: Ne prenehajte z zdravljenjem brez posveta z zdravnikom, ker se pomanjkanje vitamina E lahko ponovi in vpliva na vaše zdravje.
English: This medicine has been authorised under “exceptional circumstances”.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v »izjemnih okoliščinah«.
English: Date of latest renewal: 23 April 2014
Slovenian: Datum prve odobritve: 24. julij 2009 Datum zadnjega podaljšanja: 23. april 2014
English: As Vedrop may increase their absorption during digestion, your doctor will monitor the treatment effect and adjust the doses if necessary.
Slovenian: Ker zdravilo Vedrop lahko poveča njihovo absorpcijo med prebavo, bo vaš zdravnik nadzoroval učinek zdravljenja in po potrebi prilagodil odmerek.
English: Skip the missed dose and go back to the regular dosing schedule.
Slovenian: Preskočite pozabljeni odmerek in nadaljujte po rednem urniku.
English: 1- Open the bottle.
Slovenian: 1- Odprite steklenico.
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.
Slovenian: Deluje kot razbijajoča molekula s prostim radikalom, zaustavlja peroksidacijo polinenasičenih maščobnih kislin in je vključen v vzdrževanje stabilnosti in celovitosti celičnih membran.
English: 7- Wash the syringe with water.
Slovenian: 7- Operite brizgo z vodo.
English: Bioavailability of vitamin E from Vedrop differs from that of other medicinal products.
Slovenian: Biodostopnost vitamina E iz zdravila Vedrop se razlikuje od drugih zdravil.
English: 6- Close the bottle.
Slovenian: 6- Zaprite steklenico.
English: CONDITIONS OR RESTRICTIONS REGARDING THE SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Pharmacotherapeutic group: Vitamins, Other plain vitamin preparations; ATC code: A11HA08
Slovenian: Farmakoterapevtska skupina: Vitamini, drugi vitaminski preparati; oznaka ATC: A11HA08
English: The usual dose is 0.34 ml/kg/day.
Slovenian: Običajen odmerek je 0,34 ml/kg/dan.
English: You can take Vedrop before or during your meal, with or without water.
Slovenian: Zdravilo Vedrop lahko vzamete pred ali med obrokom, z ali brez vode.
English: Therefore, monitoring should be performed and, when necessary, doses should be adjusted.
Slovenian: Zaradi tega je treba bolnike nadzorovati in po potrebi prilagoditi odmerek.
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.
Slovenian: 3- Brizgo napolnite s tekočino tako, da izvlečete brizgo do označbe, ki se ujema s količino v mililitrih (ml), ki vam jo je predpisal zdravnik.
English: Your doctor will prescribe the dose in ml.
Slovenian: Vaš zdravnik bo predpisal odmerek v ml.
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.
Slovenian: Pri odločitvi za nadaljevanje/prekinitev dojenja ali nadaljevanje/prekinitev terapije z zdravilom Vedrop je treba upoštevati prednosti, ki jih ima dojenje za dojenčke kot tudi prednosti terapije tokofersolana na ženske.
English: Urine represents a minor elimination route of vitamin E (as glucuro-conjugate).
Slovenian: Urin predstavlja minimalno pot izločanja E vitamina (kot glukuro-konjugat).
English: • Asthenia (feeling of weakness)
Slovenian: • astenija (občutek šibkosti)
English: • Do not use this medicine after the expiry date which is stated on the box and the bottle, after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in steklenici, poleg oznake EXP. Rok uporabnosti se izteče na zadnji dan navedenega meseca.
English: What you need to know before you take Vedrop
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Vedrop
English: Vedrop is administered orally with or without water.
Slovenian: Vedrop se uporablja peroralno z ali brez vode.
English: The result is the volume of Vedrop in ml:
Slovenian: Rezultat je volumen zdravila Vedrop v ml:
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:
Slovenian: Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okvirju izvesti naslednje ukrepe:
English: The dose should be prescribed in ml.
Slovenian: Odmerek mora biti predpisan v ml.
English: It is unknown whether tocofersolan is excreted in human breast milk.
Slovenian: Ni znano, ali se tokofersolan izloča v materino mleko.
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.
Slovenian: 5- Izpraznite vsebino brizge tako, da pritisnete na njo in zdravilo izpustite: - neposredno v usta, ali - v kozarec z vode, ki jo v celoti izpijete.
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Slovenian: Zabeleženi neželeni učinki so navedeni po organskih sistemih in po pogostosti.
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).
Slovenian: Ne jemljite zdravila Vedrop - če ste alergični na E vitamin (d-alfa-tokoferol) ali katerokoli sestavino tega zdravila (navedeno v poglavju
English: Vitamin E is mainly eliminated in the bile (75%) and stools, either as free tocopherol or as oxidized forms.
Slovenian: E vitamin se v večini izloča preko žolča (75%) in blata, in sicer kot prosti tokoferol ali v oksidirani obliki.
English: Vedrop has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Vedrop nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: It should be taken into consideration by patients on a controlled sodium diet.
Slovenian: To je potrebno upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija.
English: Inform your doctor if you are pregnant as he/she will decide if the medicine may be used.
Slovenian: Obvestite svojega zdravnika, če ste noseči, saj je zdravnik tisti, ki se odloči ali lahko zdravilo uporabljate.
English: 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).
Slovenian: V podobni študiji je tokofersolan pokazal višjo biološko uporabnost kot referenčni E vitamin, ki ga je mogoče mešati z vodo, in sicer pri pediatričnih bolnikih s kronično holestazo (n=6), absorpcija je bila bistveno višja, tako maksimalno povečanje koncentracije v plazmi (p=0,008) kot tudi AUC (p=0,0026).
English: No clinical data are available on exposure to this medicine during pregnancy.
Slovenian: Na voljo ni kliničnih podatkov o izpostavljenosti zdravilu med nosečnostjo.
English: Uncommon side effects (may affect up to 1 in 100 people)
Slovenian: • driska Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov)
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.
Slovenian: 1 ml ali 2 ml brizge, priložene zdravilu, so narejene za pomoč pri odmerjanju natančnega odmerka v skladu s predpisanim odmerjanjem.
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).
Slovenian: Priporočen dnevni odmerek pri pediatričnih bolnikih, ki bolehajo za kongentialno kronično holestazo ali dedno kronično holestazo je 0,34 ml/kg/dan (17 mg/kg d-alfa-tokopferola v obliki tokoferoslana).
English: At low concentrations, tocofersolan forms micelles which enhance absorption of non-polar lipids such as fat-soluble vitamins.
Slovenian: Tokofersolan pri nizkih koncentracijah tvori micele, ki izboljšajo absorpcijo nepolarnih lipidov, kot so vitamini, ki se topijo v maščobah.
English: • Rash (eruption on the skin)
Slovenian: • osip (izpuščaj na koži)
English: Other medicines and Vedrop Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali morda jemljete katerokoli drugo zdravilo.
English: 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.
Slovenian: Zdravljenje z zdravilom Vedrop mora začet in nadzorovat zdravnik, ki ima izkušnje z zdravljenjem bolnikov, ki trpijo za kongenitalno kronično holestazo ali dedno kronično holestazo.
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.
Slovenian: Absorpcija devteriranega tokofersolana je pokazala običajni vzorec v lipoproteinih: alfa-tokoferol najprej doseže vrh v hilomikronih, nato v lipoproteinih (VLDL) v nizko gosti obliki in na koncu v lipoproteinih z nizko gostoto (LDL) in lipoproteinih z visoko gostoto (HDL) in izginjanje delčkov krivulje je vzporedno pri nadzornih osebkih.
English: Contact your doctor or pharmacist before stopping.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, preden prenehate.
English: A possible adjustment of the dose of oral anticoagulant during and after treatment with Vedrop may be necessary.
Slovenian: Mogoče bo treba prilagoditi odmerek peroralnega antikoauglansa med ali po zdravljenju z zdravilom Vedrop.
English: This medicinal product contains sodium.
Slovenian: Zdravilo prav tako vsebuje natrij.
English: The dose should be adjusted according to plasma vitamin E level.
Slovenian: Odmerek je treba prilagoditi glede na nivoje vitamina E v plazmi.
English: • Abnormal level of potassium in the blood
Slovenian: • nenormalna raven kalija v krvi
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Slovenian: E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
English: Large vitamin E doses may cause diarrhoea, abdominal pain, and other gastrointestinal disturbances.
Slovenian: Velike količine E vitamina lahko povzročijo diarejo, bolečine v trebuhu in druge motnje prebavil.
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.
Slovenian: Pri uporabi zdravila Vedrop je potrebna previdnost in natančno spremljanje delovanja ledvic, saj lahko polietilenglikol, del učinkovine tokofersolan, poškoduje vaše ledvice.
English: Fertility No data is available
Slovenian: Plodnost Nobenih podatkov ni na voljo.
English: Vedrop is a slightly viscous pale yellow oral solution in a brown glass bottle which is closed with a childresistant cap.
Slovenian: Vedrop je rahlo viskozna bledo rumena raztopina za oralno uporabo v rjavi steklenički, ki jo zapira za otroke varen pokrovček.
English: For tocofersolan no clinical data on exposed pregnancies are available.
Slovenian: Za tokofersolan ni na voljo kliničnih podatkov o vplivu na nosečnost.
English: 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).
Slovenian: Zaradi inhibicije prenašalca P-glikoproteina lahko tokofersolan poveča črevesno absorbcijo drugih spremljajočih vitaminov, ki se topijo v maščobah (A, D, E, K) ali tistih v močno lipofilinih zdravilih (kot so na primer steroidi, antibiotiki, antihistamini, ciklosporini, takrolimus).
English: The active substance d-alpha-tocopherol-polyethylene glycol 1000 succinate (tocofersolan) is a pro-drug; the active metabolite is the d-alpha-tocopherol.
Slovenian: Aktivna snov d-alfa-tokoferol-polietilen glikolova 1000 sol jantarjeve kisline (tokofersolan) je prozdravilo; aktiven metabolit je d-alfa-tokoferol.
English: 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).
Slovenian: Uporablja se za zdravljenje pomanjkanja E vitamina zaradi digestivne malabsorpcije (kjer se med prebavo hranilne snovi iz hrane ne absorbirajo dobro) pri bolnikih od rojstva (novorojenčki) do 18. leta starosti, ki trpijo za kronično holestazo (dedna ali prirojena bolezen, kjer žolč ne more prehajati iz jeter v črevesje).
English: 4- Remove the oral syringe from the bottle.
Slovenian: 4- Brizgo odstranite iz steklenice.
English: 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).
Slovenian: Izkušnje s terapijo tokofersolana pri bolnikih z ledvično okvaro ali že obstoječo okvaro jeter so pokazale, da ni potrebno prilagoditi odmerka zdravila Vedrop (glejte poglavje 4.4).
English: Caution should be exercised when prescribing to pregnant women.
Slovenian: Bodite pazljivi, ko zdravilo predpišete nosečnicam.
English: Swallow the solution with or without water.
Slovenian: Raztopino pogoltnite z ali brez vode.
English: The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke o tem zdravilu, ki bodo na voljo, in posodobila navodilo za uporabo, če bo potrebno.
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.
Slovenian: E vitamin, ki se v večini nahaja v celičnih membranah, znotraj mitohondrijev in mikrosomov, se razširi povsod (rdeče krvne celice, možgani, mišice, jetra, krvne ploščice) in se pretežno shranjuje v maščobnih tkivih.
English: 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).
Slovenian: Ker so podatki pri bolnikih z okvaro ledvic omejeni, zdravilo Vedrop uporabljajte pazljivo in z nadzorom renalne funkcije pri bolnikih z okvaro ledvic, npr. dehidriranih bolnikih (glejte poglavje 4.2).
English: Oral solution volume (ml)
Slovenian: Volumen peroralne raztopine (ml)
English: Fat-soluble vitamins (such as vitamin A, D, E or K) or highly fat-soluble medicines (such as corticoids, ciclosporin, tacrolimus, antihistamine).
Slovenian: vitamine, ki se topijo v maščobah (kot so vitamin A, D, E ali K) ali zdravila, ki se hitro topijo v maščobah (kot so kortikoidi, ciklosporin, takrolimus, antihistamin).
English: 10 ml 20 ml 60 ml
Slovenian: peroralna raztopina 10 ml 20 ml 60 ml
English: 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.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo predložil letna posodobljena poročila o novih informacijah glede učinkovitosti in varnosti zdravila pri bolnikih s prirojeno kronično holestazo ali dedno holestazo.
English: If you stop taking Vedrop
Slovenian: Če prenehate jemati zdravilo Vedrop
English: Vedrop contains vitamin E (in the form of tocofersolan).
Slovenian: Zdravilo Vedrop vsebuje E vitamin (v obliki tokofersolana).
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).
Slovenian: Študija na 12 zdravih prostovoljcih je primerjala tokofersolan z referenčnim E vitaminom, ki ga je mogoče mešati z vodo, po enojnem peroralnem odmerku 1200 i.e. Relativna biološka uporabnost tokofersolana je bila višja (Frel 1,01 ± 1,74) z AUC0-t 0,383 ± 0,203µM.h/mg, Cmax 0,013 ± 0,006, tmax 6,0 h (6,0 - 24,0) in t1/2 29,7 h (16,0 - 59,5).
English: There is no data on whether or not this medicine is present in the breast milk.
Slovenian: Ni podatkov o vsebnosti zdravila v materinem mleku.
English: The following table gives the volume of oral solution in function of patients' weights.
Slovenian: Naslednja tabela prikazuje volumen peroralne raztopine v odvisnosti od telesne mase bolnika.
English: 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
Slovenian: EU/1/09/533/001 10 ml steklenica EU/1/09/533/002 20 ml steklenica EU/1/09/533/003 60 ml steklenica
English: Driving and using machines Vedrop is not likely to affect your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Vedrop vplivalo na sposobnost vožnje in upravljanja s stroji.
English: 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).
Slovenian: Ker lahko velike količine vitamine E povečajo možnost krvavitev pri bolnikih s pomanjkanjem vitamina K ali pri bolnikih, ki peroralno jemljejo zdravila proti vitaminu K, je priporočljivo nadzorovati protrombinski čas in mednarodno normalizirano razmerje (INR).
English: Doses for administration should be extracted from the bottle using the oral syringes which are provided in the pack.
Slovenian: Odmerke je iz steklenice treba odvzemati z brizgami, ki so priložene paketu.
English: The excretion of tocofersolan in milk has not been studied in animals.
Slovenian: Študij na živalih, ki bi preučevale izločanje tokofersolana v mleko ni bilo izvedenih.
English: • Abnormal level of sodium in the blood
Slovenian: • nenormalna raven natrija v krvi
English: 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.
Slovenian: Zdravilo Vedrop se uporablja pri pomanjkanju vitamina E zaradi digestivne malabsorbcije pri pediatričnih bolnikih s kongenitalno kronično holestazo ali dedno kronično holestazo, od rojstva (novorojenčki) do 18 leta starosti.
English: Dose of Vedrop (in ml) = dose of d-alpha-tocopherol (in mg)
Slovenian: Odmerek zdravila Vedrop (v ml) = odmerek d-alfa-tokoferola (v mg)
English: Yearly, simultaneously with submission of Periodic Safety Update reports
Slovenian: Letno, sočasno s predložitvijo rednega posodobljenega poročila o varnosti zdravila (PSUR)
English: If you forget to take Vedrop
Slovenian: Če ste pozabili vzeti zdravilo Vedrop
English: Vedrop should be used with caution and liver functions closely monitored.
Slovenian: Pri uporabi zdravila Vedrop je potrebna previdnost in natančno spremljanje delovanja jeter.