natgillin/translations-raw huggingface dataset:
Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
Na voljo so omejeni podatki o ponovnem zdravljenju z bortezomibom pri bolnikih s ponovitvijo diseminiranega plazmocitoma.
Bortezomib Hospira 3.5 mg powder for solution for injection
Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje
No new safety concerns were observed when bortezomib was added to the standard paediatric pre B cell ALL chemotherapy backbone.
Pri dodatku bortezomiba standardni pediatrični pre-B-celični ALL osnovni kemoterapevtski shemi niso opazili novih vplivov na varnost.
Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Neželeni učinek Bolezni živčevja Zelo pogosti nevropatije*, periferna senzorična nevropatija, disestezija*, nevralgija*
Bortezomib Hospira treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however Bortezomib Hospira may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Zdravljenje z zdravilom Bortezomib Hospira mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem onkoloških bolnikov.
One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib -containing regimen were retreated upon progression.
Za ugotavljanje učinkovitosti in varnosti ponovnega zdravljenja z bortezomibom so izvedli odprto, enoskupinsko preskušanje faze II MMY-2036 (RETRIEVE).Stotrideset bolnikov (starih ≥ 18 let) z diseminiranim plazmocitomom, ki so predhodno imeli vsaj delni odziv na zdravljenje z bortezomibom so ponovno zdravili po napredovanju bolezni.
B=bortezomib; BTDx=bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response;
B = bortezomib; Dx = deksametazon; T = talidomid
Bortezomib Hospira 3 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 3 mg powder for solution for injection must be carefully reconstituted with 3 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Hospira 3 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Hospira 3 mg prašek za raztopino za injiciranje morate previdno rekonstituirati s 3 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
Dysacusis (inc tinnitus)* Uncommon Vertigo*, Hearing impaired (up to and inc deafness)
Občasni vertigo*, okvara sluha (vse do in vključno z gluhostjo)
Common Leukopenia*, Lymphopenia* Uncommon Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*,
Zelo pogosti trombocitopenija*, febrilna nevtropenija, nevtropenija*, levkopenija*, anemija*, limfopenija*
Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Priprava 3,5 mg viale: previdno dodajte 3,5 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
9/l on a Bortezomib Hospira dosing day (other than day 1)
• Če je na dan odmerjanja zdravila Bortezomib Hospira (razen dneva 1) število trombocitov ≤ 30 x 10
Preparation of the 2.5 mg vial: carefully add 2.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Priprava 2,5 mg viale: previdno dodajte 2,5 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
Patients eligible for stem cell transplantation
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
Subcutaneous use: Add 0.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Subkutana uporaba: dodajte 0,4 ml 0,9 % raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
Intravenous use: Add 2.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Intravenska uporaba: dodajte 2,5 ml 0,9 % raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
Bortezomib Hospira 3 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 3 mg powder for solution for injection must be carefully reconstituted with 1.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Hospira 3 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Hospira 3 mg prašek za raztopino za injiciranje morate previdno rekonstituirati z 1,2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
Bortezomib Hospira 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 3.5 mg powder for solution for injection must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje morate previdno rekonstituirati s 1,4 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
Bortezomib Hospira 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 3.5 mg powder for solution for injection must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje morate previdno rekonstituirati s 3,5 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
At least 6 months after prior therapy, bortezomib was started at the last tolerated dose of 1.3 mg/m2 (n=93) or ≤ 1.0 mg/m2 (n=37) and given on days 1, 4, 8 and 11 every 3 weeks for maximum of 8 cycles either as single agent or in combination with dexamethasone in accordance with the standard of care.
Po najmanj 6 mesecih po predhodnem zdravljenju so bortezomib uvedli v odmerku, ki ga je bolnik pri predhodnem zdravljenju še prenašal, 1,3 mg/m (n = 93) ali ≤ 1,0 mg/m2 (n = 37).
Antiviral prophylaxis is recommended in patients being treated with Bortezomib Hospira.
Bolnik prejme šest ciklov zdravljenja z zdravilom Bortezomib Hospira.
Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Priprava 3,5 mg viale: previdno dodajte 1,4 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
Intravenous use: Add 1 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Intravenska uporaba: dodajte 1 ml 0,9 % raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
Preparation of the 3 mg vial: carefully add 1.2 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Priprava 3 mg viale: previdno dodajte 1,2 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
Common Muscle spasms*, Pain in extremity, Muscular weakness Uncommon Muscle twitching, Joint swelling, Arthritis*, Joint stiffness,
Zelo pogosti mišično-skeletna bolečina* Pogosti mišični krči*, bolečine v udih, mišična šibkost
Bortezomib Hospira 2.5 mg powder for solution for injection
Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje
Antiviral prophylaxis was administered to 26% of the patients in the B+M+P arm.
V B+M+P kraku preskušanja je protivirusna zdravila prejelo 26 % bolnikov.
Preparation of the 3 mg vial: carefully add 3 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Priprava 3 mg viale: previdno dodajte 3 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
Bortezomib Hospira 2.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 2.5 mg powder for solution for injection must be carefully reconstituted with 2.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje morate previdno rekonstituirati z 2,5 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
Intravenous use: Add 3.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Intravenska uporaba: dodajte 3,5 ml 0,9% raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
Posology for previously untreated multiple myeloma patients not eligible for haematopoietic stem cell transplantation
Odmerjanje pri bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in niso primerni za presaditev krvotvornih matičnih celic
Table 2: Recommended posology for Bortezomib Hospira in combination with melphalan and prednisone Twice weekly Bortezomib Hospira (cycles 1-4)
Odmerjanje zdravila Bortezomib Hospira dvakrat na teden (cikli 1-4)
Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving bortezomib.
Sindrom reverzibilne posteriorne levkoencefalopatije (PRES - Posterior Reversible Encephalopathy Syndrome)
Pruritus*, Dermatitis*, Rash*
Zelo pogosti bolezni las* Pogosti srbenje*, dermatitis*, izpuščaj*
The benefit/risk ratio should be considered prior to continuing Bortezomib Hospira therapy.
Pred nadaljevanjem zdravljenja z zdravilom Bortezomib Hospira je potrebno oceniti razmerje med koristjo in tveganjem.
Subcutaneous use: Add 1.2 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Subkutana uporaba: dodajte 1,2 ml 0,9 % raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome
Občasni tremor, periferna senzorična in motorična nevropatija, diskinezija*, motnje koordinacije in ravnotežja v malih možganih*, izguba spomina (brez demence)*, encefalopatija*, posteriorni reverzibilni encefalopatični sindrom nevrotoksičnost, motnje s krči*, postherpetična nevralgija, motnje govora*, sindrom nemirnih nog, migrena, išias, motnje pozornosti, nenormalni refleksi*, parozmija
Bortezomib Hospira 2.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 2.5 mg powder for solution for injection must be carefully reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje morate previdno rekonstituirati z 1 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
• different reconstitution requirements for intravenous (IV) or subcutaneous (SC) use
• Različne zahteve za rekonstitucijo zdravila pri i.v.
Subcutaneous use: Add 1 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Subkutana uporaba: dodajte 1 ml 0,9 % raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
Preparation of the 2.5 mg vial: carefully add 1 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Priprava 2,5 mg viale: previdno dodajte 1 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
Intravenous use: Add 3 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Intravenska uporaba: dodajte 3 ml 0,9 % raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
Bortezomib Hospira is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21 day treatment cycle.
Priporočeni odmerek je 1,3 mg/m telesne površine, dvakrat na teden dva tedna, na 1., 4., 8. in 11. dan v 21-dnevnem ciklu zdravljenja.
1.1 Preparation of the 1 mg vial: carefully add 0.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Priprava 1 mg viale: previdno dodajte 0,4 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
Subcutaneous use: Add 1.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Subkutana uporaba: dodajte 1,4 ml 0,9% raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
Day 1 -- -- Day 4 Day 8 Day rest period
4 Dan 8 Dan premor Dan
B=bortezomib; Dx=dexamethasone; T=thalidomide a Thalidomide dose is increased to 100 mg from week 3 of Cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
V 3. tednu 1. cikla se lahko odmerek talidomida poveča na 100 mg samo, če bolnik dobro prenaša odmerek 50 mg, in na 200 mg v 2. ciklu, če bolnik dobro prenaša odmerek 100 mg.
Bortezomib Hospira 1 mg powder for solution for injection Each 5 ml vial of Bortezomib Hospira 1 mg powder for solution for injection must be carefully reconstituted with 0.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Hospira 1 mg prašek za raztopino za injiciranje Vsako 5 ml vialo zdravila Bortezomib Hospira 1 mg prašek za raztopino za injiciranje morate previdno rekonstituirati z 0,4 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
Bortezomib Hospira 1 mg powder for solution for injection Each 5 ml vial of Bortezomib Hospira 1 mg powder for solution for injection must be carefully reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Bortezomib Hospira 1 mg prašek za raztopino za injiciranje Vsako 5 ml vialo zdravila Bortezomib Hospira 1 mg prašek za raztopino za injiciranje morate previdno rekonstituirati z 1 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
Thrombocytopenia*, Neutropenia*, Anaemia*
Občasni angioedem #, preobčutljivost*
There have been fatal cases of inadvertent intrathecal administration of bortezomib.
Nenamerno intratekalno dajanje bortezomiba se je končalo s smrtnimi primeri.
B (1.3 mg/m
B (1,3 mg/m dan 1, 4
Common Hepatic enzyme abnormality* Uncommon Hepatotoxicity (inc liver disorder), Hepatitis*, Cholestasis Rare
Občasni hepatotoksičnost (vključno z boleznimi jeter), hepatitis*, holestaza
Common Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough* Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage
Občasni pancitopenija*, febrilna nevtropenija, koagulopatija*, levkocitoza*, limfadenopatija, hemolitična anemija
Bortezomib Hospira is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8 and 11 in a 21-day treatment cycle.
Priporočeni odmerek je 1,3 mg/m telesne površine, dvakrat na teden dva tedna, na 1., 4., 8. in 11. dan v 28-dnevnem ciklu zdravljenja.
1.1 Preparation of the 1mg vial: carefully add 1mlof sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Priprava 1 mg viale: previdno dodajte 1 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
Table 4: Posology for Bortezomib Hospira combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation B+Dx
Preglednica 4: Odmerjanje zdravila Bortezomib Hospira pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, pri katerih je presaditev krvotvornih matičnih celic primerna.
M (9 mg/m P (60 mg/m
(60 mg/m
222 subjects were enrolled into the study; 221 subjects were treated with bortezomib Hazards ratio estimate is based on a Cox model adjusted for stratification factors: ISS staging and number of prior lines.
b V preskušanje je bilo vključenih 222 preskušancev; 221 preskušancev se je zdravilo z bortezomibom.
Subcutaneous reconstitution:
Rekonstituirana raztopina
Day rest period
Dan premor
HR b (95% CI)=0.63
133 (54,7 %) 165 (67,6 %) HR b (95 % IZ) = 0,63 (0,50; 0,79); vrednost p d < 0,001
• that Bortezomib Hospira is to be given only by IV or SC injections; no other route of administration is allowed
• Zdravilo Bortezomib Hospira se lahko injicira samo i.v.
• Brittle or weak nails
• krhki ali lomljivi nohti
Efficacy results are presented in Table 11:
Podatki o učinkovitosti so navedeni v preglednici 11.
Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ]
b Nanaša se na stopnjo odziva po drugi presaditvi pri posameznikih, pri katerih je bila le-ta izvedena
• Dosing Slide Rule
• odpoved ledvic
The recommended daily dose is 0.34 ml per kilogram body weight.
Priporočeni dnevni odmerek je 0,34 ml na kilogram telesne mase.
The European Commission granted a marketing authorisation valid throughout the European Union for Vedrop on 24 July 2009.
Evropska komisija je dovoljenje za promet z zdravilom Vedrop, veljavno po vsej Evropski uniji, izdala 24. julija 2009.
It has a number of actions in the body, including protecting the nervous system from damage.
Ima številne učinke na telo, vključno z zaščito živčnega sistema pred poškodbami.
What measures are being taken to ensure the safe and effective use of Vedrop?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vedrop?
The full EPAR for Vedrop can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vedrop je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This dose should be adjusted according to the amount of vitamin E in the patient's blood.
Ta odmerek je treba prilagoditi glede na količino vitamina E v bolnikovi krvi.
This is a summary of the European public assessment report (EPAR) for Vedrop.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vedrop.
What is Vedrop and what is it used for?
Kaj je zdravilo Vedrop in za kaj se uporablja?
The most common side effect with Vedrop (which may affect up to 1 in 10 people) is diarrhoea.
Najpogostejši neželeni učinek zdravila Vedrop (ki se lahko pojavi pri največ 1 bolniku od 10) je driska.
Other information about Vedrop
Druge informacije o zdravilu Vedrop
This is because it has not been possible to obtain complete information about Vedrop due to the rarity of the disease.
Do tega je prišlo zato, ker zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o njem.
The company also presented information on the use of Vedrop in patients with cystic fibrosis, but withdrew its application for this disease during the evaluation of the medicine.
Družba je predstavila tudi informacije o uporabi zdravila Vedrop pri bolnikih s cistično fibrozo, vendar je med vrednotenjem zdravila umaknila svojo vlogo za to bolezen.
Vedrop has been authorised under ‘exceptional circumstances'.
Zdravilo Vedrop je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
Vitamin E is a natural substance that cannot be made by the body and is therefore needed in the diet.
Vitamin E je naravna snov, ki je telo ne more tvoriti in jo je zato treba zagotoviti s hrano.
To support the use of Vedrop, the company presented information from the scientific literature, including the results of three studies in a total of 92 children and adolescents with chronic cholestasis who were given tocofersolan for about two years.
Družba je v podporo uporabi zdravila Vedrop predstavila informacije iz znanstvene literature, vključno z izidi treh študij pri skupno 92 otrocih in mladostnikih s kronično holestazo, ki so približno dve leti prejemali tokofersolan.
This should be checked regularly.
Količino vitamina E je treba redno preverjati.
Because vitamin E dissolves in fats but not in water, it can only be absorbed from the gut into the body alongside fat particles.
Ker se vitamin E topi v maščobah, in ne v vodi, se lahko iz črevesja v telo absorbira le skupaj z maščobnimi delci.
What are the risks associated with Vedrop?
Kakšna tveganja so povezana z zdravilom Vedrop?
What benefits of Vedrop have been shown in studies?
Kakšne koristi je zdravilo Vedrop izkazalo v študijah?
It is not intended to provide practical advice on how to use Vedrop.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Vedrop approved?
Zakaj je bilo zdravilo Vedrop odobreno?
The European Medicines Agency decided that Vedrop's benefits are greater than its risks and recommended that Vedrop be given marketing authorisation.
Evropska agencija za zdravila je sklenila, da so koristi zdravila Vedrop večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
The studies showed that Vedrop could correct vitamin E levels in patients with chronic cholestasis and that it might improve or prevent neurological symptoms, especially in patients aged below three years.
Študije so pokazale, da lahko zdravilo Vedrop poveča ravni vitamina E pri bolnikih s kronično holestazo in da bi lahko izboljšalo ali preprečilo nevrološke simptome, zlasti pri bolnikih, mlajših od treh let.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vedrop have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Vedrop upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Vedrop is a medicine used to treat or prevent vitamin E deficiency (low vitamin E levels).
Zdravilo Vedrop se uporablja za zdravljenje ali preprečevanje pomanjkanja vitamina E (nizkih ravni vitamina E).
For more information about treatment with Vedrop, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Vedrop preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For the full list of all side effects and restrictions with Vedrop, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Vedrop glejte navodilo za uporabo.
Vedrop must not be used in premature babies.
Zdravilo Vedrop se ne sme uporabljati pri nedonošenčkih.
Tocofersolan can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet.
Tokofersolan se lahko absorbira iz črevesja otrok, ki imajo težave z absorpcijo maščob in vitamina E iz hrane.
The active substance in Vedrop, tocofersolan, is vitamin E that has been made water soluble by attaching it to a chemical called polyethylene glycol.
Zdravilna učinkovina v zdravilu Vedrop, tokofersolan, je vitamin E, izdelan tako, da se topi v vodi, ker se veže na kemično snov, imenovano polietilen glikol.