natgillin/translations-raw huggingface dataset:
If you take more Rivastigmine Sandoz than you should 
Če ste vzeli večji odmerek zdravila Rivastigmin Sandoz, kot bi smeli
You should not breast-feed during treatment with Rivastigmine Sandoz. 
Med zdravljenjem z zdravilom Rivastigmin Sandoz ne smete dojiti.
• Take Rivastigmine Sandoz twice a day, in the morning and evening, with food. 
• Zdravilo Rivastigmin Sandoz jemljite s hrano dvakrat na dan, zjutraj in zvečer.
- Capsule fill: - Microcrystalline cellulose - Magnesium stearate - Hypromellose - Silica, colloidal anhydrous 
Polnilo kapsule: - mikrokristalna celuloza - magnezijev stearat - hipromeloza - brezvoden koloidni silicijev dioksid
The European Medicines Agency has waived the obligation to submit the results of studies with rivastigmine in all subsets of the paediatric population in the treatment of Alzheimer's dementia and in the treatment of dementia in patients with idiopathic Parkinson's disease (see section 4.2 for information on paediatric use). 
Rivastigmin Sandoz za vse skupine pediatrične populacije glede zdravljenja Alzheimerjeve demence in zdravljenja demence pri bolnikih z idiopatsko Parkinsonovo boleznijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Oral solution Novartis Pharma GmbH Roonstrasse 25 
Peroralna raztopina Novartis Pharma GmbH Roonstrasse 25
If you accidentally take more Rivastigmine Sandoz than you should, inform your doctor . 
Če nehote vzamete več zdravila Rivastigmin Sandoz, kot bi smeli, obvestite svojega zdravnika.
Therefore, caution should be exercised when rivastigmine is combined with beta-blockers and also other bradycardia agents (e.g.class III antiarrhythmic agents, calcium channel antagonists, digitalis glycoside, pilocarpin). 
Zato je treba previdno ravnati pri uporabi rivastigmina v kombinaciji z zaviralci receptorjev beta in drugimi zdravili proti bradikardiji (npr. antiaritmiki iz skupine III, antagonisti kalcijevih kanalčkov, digitalisovi glikozidi,
Rivastigmine may cause bradycardia which constitutes a risk factor in the occurrence of torsade de pointes, predominantly in patients with risk factors. 
Rivastigmin lahko povzroči bradikardijo, ki predstavlja dejavnik tveganja za pojav torsade de pointes,
What Rivastigmine Sandoz looks like and contents of the pack 
Izgled zdravila Rivastigmin Sandoz in vsebina pakiranja
If you are pregnant, the benefits of using Rivastigmine Sandoz must be assessed against the possible effects on your unborn child. Rivastigmine Sandoz should not be used during pregnancy unless clearly necessary. 
V primeru, da ste noseči, je treba pretehtati koristi uporabe zdravila Rivastigmin Sandoz in možne učinke na nerojenega otroka.
One of the inactive ingredients in Rivastigmine Sandoz oral solution is sodium benzoate. 
Ena od neaktivnih sestavin peroralne raztopine Rivastigmin Sandoz je natrijev benzoat.
The active substance of Rivastigmine Sandoz is rivastigmine. 
Zdravilna učinkovina v zdravilu Rivastigmin Sandoz je rivastigmin.
There is no relevant use of Rivastigmine Sandoz in the paediatric population in the treatment of Alzheimer's disease. 
V pediatrični populaciji ni ustrezne uporabe zdravila Rivastigmin Sandoz za zdravljenje Alzheimerjeve bolezni.
Package leaflet: Information for the patient Rivastigmine Sandoz 2 mg/ml oral solution rivastigmine 
Navodilo za uporabo: Informacije za bolnika Rivastigmin Sandoz 2 mg/ml peroralna raztopina rivastigmin
Since bradycardia constitutes a risk factor in the occurrence of torsades de pointes, the combination of rivastigmine with torsades de pointes-inducing medicinal products such as antipsychotics i.e. some phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, methadone, pentamidine and moxifloxacine should be observed with caution and clinical monitoring (ECG) may also be required. 
nekateri fenotiazini (klorpromazin, levomepromazin), benzamidi (sulpirid, sultoprid, amisulprid, tiaprid, veraliprid), pimozid, haloperidol, droperidol, cisaprid, citalopram, difemanil, eritromicin iv, halofantrin, mizolastin, metadon, pentamidin in moksifloksacin.
Rivastigmine Sandoz 3 mg and 6 mg hard capsules: 
Rivastigmin Sandoz 3 mg in 6 mg trde kapsule:
One of the excipients in Rivastigmine Sandoz oral solution is sodium benzoate. 
Ena od pomožnih snovi peroralne raztopine zdravila Rivastigmin Sandoz je natrijev benzoat.
There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer's disease. 
Pediatrična populacija Zdravilo Rivastigmin ni primerno za uporabo pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
How to take Rivastigmine Sandoz 
Kako jemati zdravilo Rivastigmin Sandoz
Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category. 
V preglednicah 1 in preglednici 2 so neželeni učinki navedeni glede na organski sistem po MedDRA
Each Rivastigmine Sandoz 1.5 mg capsule contains 1.5 mg of rivastigmine. 
Ena kapsula Rivastigmin Sandoz 1,5 mg vsebuje 1,5 mg rivastigmina.
Some people who have accidentally taken too much Rivastigmine Sandoz have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. 
Rivastigmin Sandoz, je prišlo do navzee (slabosti s siljenjem na bruhanje), bruhanja, driske, visokega krvnega tlaka in halucinacij.
Each Rivastigmine Sandoz 6 mg capsule contains 6 mg of rivastigmine. 
Ena kapsula Rivastigmin Sandoz 6 mg vsebuje 6 mg rivastigmina.
Each Rivastigmine Sandoz 4.5 mg capsule contains 4.5 mg of rivastigmine. 
Ena kapsula Rivastigmin Sandoz 4,5 mg vsebuje 4,5 mg rivastigmina.
Each Rivastigmine Sandoz 3 mg capsule contains 3 mg of rivastigmine. 
Ena kapsula Rivastigmin Sandoz 3 mg vsebuje 3 mg rivastigmina.
Cardiac arrhythmia (e.g. bradycardia, atrioventricular block, atrial fibrillation and tachycardia) 
Srčne bolezni redki zelo redki pogostnost neznana angina pektoris srčne aritmije (npr. bradikardija, atrioventrikularni blok, atrijska fibrilacija in tahikardija) bolezen sinusnega vozla
Rivastigmine Sandoz 1.5 mg hard capsules: 
Rivastigmin Sandoz 1,5 mg trde kapsule:
• Fits (seizures) 
• zgaga, • hujšanje
Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine. 
En ml vsebuje rivastigminijev hidrogentartrat, ki ustreza 2 mg rivastigmina.
Rivastigmine Sandoz 2 mg/ml oral solution 
Rivastigmin Sandoz 2 mg/ml peroralna raztopina
Only for carton box: Rivastigmine Sandoz 2 mg/ml 
Samo za kartonsko škatlo: Rivastigmin Sandoz 2 mg/ml
Rivastigmine Sandoz 4.5 mg hard capsules: 
Rivastigmin Sandoz 4,5 mg trde kapsule:
Only for carton box: Rivastigmine Sandoz 1.5 mg 
Samo za kartonsko škatlo: Rivastigmin Sandoz 1,5 mg
Each capsule contains rivastigmine hydrogen tartrate corresponding to 6mg rivastigmine. 
Ena kapsula vsebuje rivastigminijev hidrogentartrat, ki ustreza 6 mg rivastigmina.
• The highest dose that should be taken is 6.0 mg twice a day. 
• Najvišji dovoljeni odmerek je 6 mg dvakrat na dan.
Each capsule contains rivastigmine hydrogen tartrate corresponding to 4,5mg rivastigmine. 
Ena kapsula vsebuje rivastigminijev hidrogentartrat, ki ustreza 4,5 mg rivastigmina.
Only for carton box: Rivastigmine Sandoz 4.5 mg 
Samo za kartonsko škatlo: Rivastigmin Sandoz 4,5 mg
Only for carton box: Rivastigmine Sandoz 6 mg 
Samo za kartonsko škatlo: Rivastigmin Sandoz 6 mg
Rivastigmine Sandoz 2 mg/ml oral solution rivastigmine (as hydrogen tartrate) 
Rivastigmin Sandoz 2 mg/ml peroralna raztopina rivastigmin (v obliki hidrogentartrata)
Only for carton box: Rivastigmine Sandoz 3 mg 
Samo za kartonsko škatlo: Rivastigmin Sandoz 3 mg
Agitation Confusion Anxiety Nightmares Insomnia Depression Hallucinations 
Psihiatrične motnje pogosti pogosti pogosti pogosti občasni občasni zelo redki pogostnost neznana agitiranost zmedenost tesnoba nočne more nespečnost depresija halucinacije agresivnost, nemir
Rivastigmine Sandoz 1.5 mg hard capsules rivastigmine (as hydrogen tartrate) 
Rivastigmin Sandoz 1,5 mg trde kapsule rivastigmin (v obliki hidrogentartrata)
Rivastigmine Sandoz 4.5 mg hard capsules rivastigmine (as hydrogen tartrate) 
Rivastigmin Sandoz 4,5 mg trde kapsule rivastigmin (v obliki hidrogentartrata)
- Rivastigmine Sandoz 3 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “RIV 3 mg” on the body. 
- Rivastigmin Sandoz 3 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo oranžen pokrovček in oranžno telo kapsule z rdečim napisom “RIV 3 mg”.
- Rivastigmine Sandoz 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “RIV 4.5 mg” on the body. 
- Rivastigmin Sandoz 4,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in rdeče telo kapsule z belim napisom “RIV 4,5 mg”.
How to store Rivastigmine Sandoz 
Shranjevanje zdravila Rivastigmin Sandoz
Rivastigmine Sandoz is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour. 
To je napredujoča bolezen možganov, ki postopoma prizadene spomin in intelektualne sposobnosti ter vpliva na vedenje bolnika.
- Rivastigmine Sandoz 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint “RIV 1.5 mg” on the body. 
- Rivastigmin Sandoz 1,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rumen pokrovček in rumeno telo kapsule z rdečim napisom “RIV 1,5 mg”.
Each capsule contains rivastigmine hydrogen tartrate corresponding to 3mg rivastigmine. 
Ena kapsula vsebuje rivastigminijev hidrogentartrat, ki ustreza 3 mg rivastigmina.
blisters. 
PDS.
- Rivastigmine Sandoz 6 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “RIV 6 mg” on the body. 
- Rivastigmin Sandoz 6 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in oranžno telo kapsule z rdečim napisom “RIV 6 mg”.
Rivastigmine Sandoz 6 mg hard capsules rivastigmine (as hydrogen tartrate) 
Rivastigmin Sandoz 6 mg trde kapsule rivastigmin (v obliki hidrogentartrata)
Rivastigmine Sandoz 3 mg hard capsules rivastigmine (as hydrogen tartrate) 
Rivastigmin Sandoz 3 mg trde kapsule rivastigmin (v obliki hidrogentartrata)
Paediatric population 
Vsi proučevani bolniki
Other side effects seen with transdermal patches and which may occur with the hard capsules: 
• nepravilen srčni utrip in motnje koordinacije gibov Drugi neželeni učinki, ki so jih opazili pri transdermalnih obližih in se lahko pojavijo tudi pri trdih kapsulah:
It is available as tablets (1, 3, 5 and 7 mg). 
Na voljo je v obliki tablet (1, 3, 5 in 7 mg).
The European Commission granted a marketing authorisation valid throughout the European Union for Inlyta on 3 September 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Inlyta, veljavno po vsej Evropski uniji, izdala 3. septembra 2012.
Regarding its safety, the side effects of the medicine are similar to other medicines in the same class and are considered to be acceptable and manageable. 
Kar zadeva varnost zdravila, so njegovi neželeni učinki podobni kot pri drugih zdravilih v istem razredu ter se štejejo za sprejemljive in obvladljive.
What measures are being taken to ensure the safe and effective use of Inlyta? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Inlyta?
The full EPAR for Inlyta 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 Inlyta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
In patients taking certain other medicines, the doctor may need to adjust the dose of Inlyta. 
Pri bolnikih, ki jemljejo nekatera druga zdravila, bo moral zdravnik morda prilagoditi odmerek zdravila Inlyta.
The dose can be adjusted according to the patient's response. 
Lahko se ga prilagodi glede na bolnikov odziv.
The main measure of effectiveness was how long the patients lived without their tumour getting worse. 
Glavno merilo učinkovitosti je bilo, kako dolgo so bolniki živeli brez napredovanja tumorja.
The recommended starting dose is 5 mg twice a day, taken approximately 12 hours apart. 
Priporočeni začetni odmerek znaša 5 mg dvakrat dnevno v približno 12-urnih presledkih.
This is a summary of the European public assessment report (EPAR) for Inlyta. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Inlyta.
The most common side effects with Inlyta (seen in more than 20% of patients) are diarrhoea, hypertension (high blood pressure), fatigue (tiredness), dysphonia (speech disturbance), nausea (feeling sick), vomiting, decreased appetite, weight loss, palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms of the hands and soles of the feet), haemorrhage (bleeding), hypothyroidism (an underactive thyroid gland), protein in urine, cough and constipation. 
Najpogostejši neželeni učinki zdravila (opaženi pri več kot 20 % bolnikov) so driska, hipertenzija (visok krvni tlak), utrujenost, disfonija (hripavost), navzeja (slabost), bruhanje, zmanjšanje teka, zmanjšanje telesne mase, sindrom palmarno-plantarne eritrodisestezije (izpuščaj na dlaneh in podplatih ter njihova otrplost), krvavitev, hipotiroidizem (nezadostno delovanje ščitnice), beljakovine v urinu, kašelj in zaprtje.
In patients who tolerate the 5 mg dose well, who do not have high blood pressure and are not taking blood pressure medicines, the dose may be increased first to 7 mg then to a maximum of 10 mg twice a day. 
Pri bolnikih, ki dobro prenašajo 5-miligramski odmerek, nimajo visokega krvnega tlaka in ne jemljejo zdravil za njegovo zdravljenje, se lahko odmerek poveča najprej na 7 mg, nato pa na največ 10 mg dvakrat dnevno.
Other information about Inlyta 
Druge informacije o zdravilu Inlyta
For more information about treatment with Inlyta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Inlyta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Patients taking Inlyta lived for an average of 6.7 months without the disease getting worse, compared with 4.7 months in the patients taking sorafenib. 
Bolniki, ki so jemali zdravilo Inlyta, so živeli povprečno 6,7 meseca brez poslabšanja bolezni, bolniki, ki so jemali sorafenib, pa 4,7 meseca.
A risk management plan has been developed to ensure that Inlyta is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Inlyta je bil pripravljen načrt obvladovanja tveganj.
Patients with moderately reduced liver function should receive a starting dose of 2 mg twice a day. 
Bolniki z zmerno okvaro jeter morajo prejemati začetni odmerek 2 mg dvakrat dnevno.
What benefit has Inlyta shown during the studies? 
Kakšne koristi je zdravilo Inlyta izkazalo med študijami?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Inlyta. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Inlyta, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The CHMP therefore decided that Inlyta's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor CHMP je zato zaključil, da so koristi zdravila Inlyta večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
What is the risk associated with Inlyta? 
Kakšna tveganja so povezana z zdravilom Inlyta?
Why has Inlyta been approved? 
Zakaj je bilo zdravilo Inlyta odobreno?
Effects were better for those patients who were previously treated with cytokines rather than sunitinib. 
Učinki so bili boljši pri bolnikih, ki so se predhodno zdravili s citokini, kot pri tistih, ki so se zdravili s sunitinibom.
Inlyta is a medicine that contains the active substance axitinib. 
Inlyta je zdravilo, ki vsebuje zdravilno učinkovino aksitinib.
For the full list of all side effects and restrictions with Inlyta, see the package leaflet. 
Za seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Inlyta glejte navodilo za uporabo.
Treatment with Inlyta should be started by doctors who have experience in using cancer medicines. 
Zdravljenje z zdravilom Inlyta lahko uvede zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
Inlyta should not be used in patients with severely reduced liver function. 
Zdravilo Inlyta se ne sme uporabljati pri bolnikih s hudo okvaro jeter.
VEGF receptors are involved in the growth and spread of cancer cells and in the development of blood vessels that supply the tumours. 
Ti receptorji sodelujejo pri rasti in širjenju rakavih celic ter pri razvoju krvnih žil, ki oskrbujejo tumorje.
The active substance in Inlyta, axitinib, works by blocking some enzymes known as tyrosine kinases that are found in ‘vascular endothelial growth factor' (VEGF) receptors on the surface of cancer cells. 
Aksitinib, zdravilna učinkovina v zdravilu Inlyta, deluje tako, da zavira nekatere encime, znane kot tirozinske kinaze, ki so prisotni v receptorjih žilnih endotelijskih rastnih faktorjev (vascular endothelial growth factors - VEGF) na površini rakavih celic.
It may be necessary to reduce the dose or interrupt treatment to manage certain side effects. 
Za obvladovanje nekaterih neželenih učinkov bi morda bilo treba zmanjšati odmerek ali prekiniti zdravljenje.
Inlyta has been compared with sorafenib (another cancer medicine) in one main study involving 723 patients with advanced renal cell carcinoma whose previous treatment with other cancer medicines such as sunitinib or cytokines had failed. 
Zdravilo Inlyta so primerjali s sorafenibom (drugim zdravilom za zdravljenje raka) v glavni študiji, v kateri je sodelovalo 723 bolnikov z napredovalim karcinomom ledvičnih celic, ki so se predhodno neuspešno zdravili z drugimi zdravili za zdravljenje rakavih bolezni, kot so sunitinib ali citokini.
Inlyta is used when treatment with Sutent (sunitinib) or ‘cytokines' (other cancer medicines) has failed. 
Zdravilo Inlyta se uporablja, kadar zdravljenje z zdravilom Sutent (sunitinib) ali s citokini (drugimi zdravili za zdravljenje raka) ni bilo uspešno.
Inlyta was more effective than sorafenib in treating advanced renal cell carcinoma. 
Zdravilo Inlyta je bilo učinkovitejše od sorafeniba pri zdravljenju napredovalega karcinoma ledvičnih celic.
The CHMP concluded that the effectiveness of Inlyta in treating patients with advanced renal cell carcinoma for whom treatment with Sutent or a cytokine failed has been demonstrated. 
Odbor CHMP je ugotovil, da je bila dokazana učinkovitost zdravila Inlyta pri zdravljenju bolnikov z napredovalim karcinomom ledvičnih celic, pri katerih zdravljenje z zdravilom Sutent ali citokinom ni bilo uspešno.
Inlyta is used to treat adults with advanced renal cell carcinoma, a type of kidney cancer. 
Zdravilo Inlyta se uporablja pri odraslih za zdravljenje napredovalega karcinoma ledvičnih celic, tj. vrste ledvičnega raka.
By blocking these receptors, Inlyta helps to reduce the growth and spread of the cancer and cut off the blood supply that keeps the cancer cells growing. 
Zdravilo Inlyta z njihovim zaviranjem omogoča upočasnitev rasti in širjenja raka ter prekinitev oskrbe s krvjo, ki omogoča rast rakavih celic.
What is Inlyta used for? 
Za kaj se zdravilo Inlyta uporablja?
What is Inlyta? 
Kaj je zdravilo Inlyta?
How has Inlyta been studied? 
Kako je bilo zdravilo Inlyta raziskano?
How is Inlyta used? 
Kako se zdravilo Inlyta uporablja?
This overview was last updated in 04-2018. 
Povzetek je bil nazadnje posodobljen 04-2018.
It involved 366 adults and children 2 years of age and over. 
Vključevala je 366 odraslih in otrok, starejših od dveh let.
This was switched to a full marketing authorisation on 16 November 2015. 
To je bilo 16. novembra 2015 spremenjeno v običajno dovoljenje za promet.
What measures are being taken to ensure the safe and effective use of Votubia? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Votubia?
Votubia was originally given ‘conditional authorisation' because there was more evidence to come about the medicine, in particular its long-term effects. 
Zdravilo Votubia je prvotno pridobilo „pogojno dovoljenje za promet“, ker je bilo pričakovanih še več dokazov o zdravilu, zlasti o njegovih dolgoročnih učinkih.
It is available as tablets (2.5, 5 and 10 mg) and as dispersible tablets (1, 2, 3 and 5 mg) and is taken by mouth once a day at the same time every day, consistently either with or without food. 
Na voljo je v obliki tablet (2,5 mg, 5 mg in 10 mg) in disperzibilnih tablet (1 mg, 2 mg, 3 mg in 5 mg) ter se jemlje peroralno enkrat na dan, vsak dan ob istem času, vedno s hrano ali vedno brez nje.
Other information about Votubia 
Druge informacije o zdravilu Votubia
As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full authorisation. 
Ker je družba predložila dodatne zahtevane podatke, je bilo dovoljenje za promet spremenjeno iz pogojnega v običajno.
Renal angiomyolipoma 
Ledvični angiomiolipom
Votubia received a conditional marketing authorisation valid throughout the EU on 2 September 2011. 
Za zdravilo Votubia je bilo 2. septembra 2011 izdano dovoljenje za promet, veljavno po vsej EU.
An overview of Votubia and why it is authorised in the EU 
Pregled zdravila Votubia in zakaj je odobreno v EU
If patients experience severe side effects the doctor may need to reduce the dose or interrupt treatment temporarily. 
Če pri bolniku pride do hudih neželenih učinkov, bo zdravnik morda moral odmerek zmanjšati ali zdravljenje začasno prekiniti.
The Agency therefore concluded that the benefits of Votubia outweigh its risks and recommended that it be given marketing authorisation. 
Agencija je zato zaključila, da koristi zdravila Votubia odtehtajo z njim povezana tveganja, in priporočila, da se zanj izda dovoljenje za promet.
What benefits of Votubia have been shown in studies? 
Kakšne koristi je zdravilo Votubia izkazalo v študijah?
What is Votubia and what is it used for? 
Kaj je zdravilo Votubia in za kaj se uporablja?
As for all medicines, data on the use of Votubia are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Votubia stalno spremljajo.
Further information on Votubia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Nadaljnje informacije za zdravilo Votubia so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The summary of the opinion of the Committee for Orphan Medicinal Products for Votubia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Votubia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.