natgillin/translations-raw huggingface dataset:
Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “RIV 1.5 mg” on the body.
Bjelkasti do žućkasti prašak u kapsuli sa žutom kapicom i žutim tijelom s crvenom oznakom „RIV 1,5 mg“ na tijelu.
- 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 tvrde kapsule, koje sadrže bjelkasti do žućkasti prašak, imaju žutu kapicu i žuto tijelo s crvenom oznakom „RIV 1,5 mg“.
DK-2300 Kööpenhamina S/Köpenhamn S E-mail: info.sandoz-dk@sandoz.com
DK-2300 Kööpenhamina S/Köpenhamn S E-pošta: info.sandoz-dk@sandoz.com
Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “RIV 4.5 mg” on the body.
Bjelkasti do žućkasti prašak u kapsuli s crvenom kapicom i crvenim tijelom s bijelom oznakom „RIV 4,5 mg“ na tijelu.
Each capsule contains rivastigmine hydrogen tartrate corresponding to 6mg rivastigmine.
Svaka kapsula sadrži rivastigmin hidrogentartarat koji odgovara 6 mg rivastigmina.
E-mail: info.sandoz-nl@sandoz.com
E-pošta: info.sandoz-nl@sandoz.com
PSURs
Proljev
Only for carton box: Rivastigmine Sandoz 6 mg
Samo za kartonsku kutiju: Rivastigmin Sandoz 6 mg
Only for carton box: Rivastigmine Sandoz 4.5 mg
Samo za kartonsku kutiju: Rivastigmin Sandoz 4,5 mg
Rivastigmine Sandoz 4.5 mg hard capsules rivastigmine (as hydrogen tartrate)
Rivastigmin Sandoz 4,5 mg tvrde kapsule rivastigmin (u obliku rivastigmin hidrogentartarata)
Each capsule contains rivastigmine hydrogen tartrate corresponding to 1,5mg rivastigmine.
Svaka kapsula sadrži rivastigmin hidrogentartarat koji odgovara 1,5 mg rivastigmina.
Each capsule contains 6 mg of rivastigmine (as hydrogen tartrate).
Jedna kapsula sadrži 6 mg rivastigmina (u obliku rivastigmin hidrogentartarata).
Each capsule contains rivastigmine hydrogen tartrate corresponding to 4,5mg rivastigmine.
Svaka kapsula sadrži rivastigmin hidrogentartarat koji odgovara 4,5 mg rivastigmina.
Oral solution Novartis Pharma GmbH Roonstrasse 25
Oralna otopina Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg
- 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 tvrde kapsule, koje sadrže bjelkasti do žućkasti prašak, imaju crvenu kapicu i crveno tijelo s bijelom oznakom „RIV 4,5 mg“.
Each capsule contains 1.5 mg of rivastigmine (as hydrogen tartrate).
Jedna kapsula sadrži 1,5 mg rivastigmina (u obliku rivastigmin hidrogentartarata).
Only for carton box: Rivastigmine Sandoz 3 mg
Samo za kartonsku kutiju: Rivastigmin Sandoz 3 mg
DK-2300 København S E-mail: info.sandoz-dk@sandoz.com
DK-2300 København S E-pošta: info.sandoz-dk@sandoz.com
Abdominal pain and dyspepsia Salivary hypersecretion
Proljev Bol u abdomenu i dispepsija
Agitation Confusion Anxiety Nightmares Insomnia Depression Hallucinations
Omaglica Glavobolja Somnolencija Tremor Sinkopa Napadaji
Balance disorder
Poremećaj kretanja
• Fainting or accidentally falling
• Teškoće sa spavanjem • Nesvjestica ili nehotično padanje
Rivastigmine Sandoz 6 mg hard capsules rivastigmine (as hydrogen tartrate)
Rivastigmin Sandoz 6 mg tvrde kapsule rivastigmin (u obliku rivastigmin hidrogentartarata)
Rivastigmine Sandoz 1.5 mg hard capsules rivastigmine (as hydrogen tartrate)
Rivastigmin Sandoz 1,5 mg tvrde kapsule rivastigmin (u obliku rivastigmin hidrogentartarata)
Each capsule contains 3 mg of rivastigmine (as hydrogen tartrate).
Jedna kapsula sadrži 3 mg rivastigmina (u obliku rivastigmin hidrogentartarata).
Rivastigmine Sandoz 2 mg/ml oral solution rivastigmine (as hydrogen tartrate)
Rivastigmin Sandoz 2 mg/ml oralna otopina rivastigmin (u obliku rivastigmin hidrogentartarata)
- 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 tvrde kapsule, koje sadrže bjelkasti do žućkasti prašak, imaju crvenu kapicu i narančasto tijelo s crvenom oznakom „RIV 6 mg“.
DK-2300 Köpenhamn S E-mail: info.sandoz-dk@sandoz.com
DK-2300 Köpenhamn S E-pošta: info.sandoz-dk@sandoz.com
Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “RIV 6 mg” on the body.
Bjelkasti do žućkasti prašak u kapsuli s crvenom kapicom i narančastim tijelom s crvenom oznakom „RIV 6 mg“ na tijelu.
Rivastigmine Sandoz 3 mg hard capsules rivastigmine (as hydrogen tartrate)
Rivastigmin Sandoz 3 mg tvrde kapsule rivastigmin (u obliku rivastigmin hidrogentartarata)
Abdominal pain and dyspepsia Gastric and duodenal ulcers Gastrointestinal haemorrhage Pancreatitis
Bol u abdomenu i dispepsija Ulkusi želuca i dvanaesnika Gastrointestinalno krvarenje
Each capsule contains rivastigmine hydrogen tartrate corresponding to 3mg rivastigmine.
Svaka kapsula sadrži rivastigmin hidrogentartarat koji odgovara 3 mg rivastigmina.
- 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 tvrde kapsule , koje sadrže bjelkasti do žućkasti prašak, imaju narančastu kapicu i narančasto tijelo s crvenom oznakom „RIV 3 mg“.
Common (may affect up to 1 in 10 people)
Često (pojavljuje se u 1 na 10 osoba)
Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “RIV 3 mg” on the body.
Bjelkasti do žućkasti prašak u kapsuli s narančastom kapicom i narančastim tijelom s crvenom oznakom „RIV 3 mg“ na tijelu.
Hepatic impairment
Poremećaj hoda
Uncommon (may affect up to 1 in 100 people)
Manje često (pojavljuje se u 1 na 100 osoba)
These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance based measure of cognition), the CIBIC-Plus (Clinician's Interview Based Impression of Change-Plus, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (Progressive Deterioration Scale, a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities relating to finances, etc.).
uključujući osobnu higijenu, hranjenje, oblačenje, poslove vezane za domaćinstvo kao što su odlazak u kupovinu, očuvanje sposobnosti orijentiranja u okolini, kao i uključivanje u aktivnosti koje se odnose na financije itd.).
Other side effects seen with transdermal patches and which may occur with the oral solution:
Ostale nuspojave primijećene s flasterima za kožu i koje se mogu javiti kod primjene oralne otopine: Često (pojavljuju se u 1 na 10 osoba)
Patients involved in this study had an MMSE (Mini-Mental State Examination) score of 10-24.
Ispitivani bolesnici imali su broj bodova od 10 - 24 na MMSE ljestvici (engl.
NAME OF THE MARKETING AUTHORISATION HOLDER
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Parkinsonism
Parkinsonizam Hipokinezija
The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson's disease treated with rivastigmine transdermal patches: agitation (common).
Parkinsonovom bolešću liječenih rivastigminskim transdermalnim flasterima: agitacija (često).
Taking this medicine
PRIMJENU LIJEKA
Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg. - The other ingredients are: sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye (E104) and purified water.
- natrijev benzoat - citratna kiselina - natrijev citrat - kinolin žuta boja WS (E104)
Absorption
Agresivnost
Anxiety
Tjeskoba
Common Not known
Rijetko Nije poznato
Renal impairment
Tremor Omaglica
D. CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I
Clinical studies in Alzheimer's dementia
Alzheimerove bolesti.
Hepatobiliary disorders
Diskinezija Parkinsonizam Hipokinezija
It is available as tablets (1, 3, 5 and 7 mg).
Dostupan je u obliku tableta (1, 3, 5 i 7 mg).
Inlyta axitinib
Inlyta aksitinib
‘Advanced' means that the cancer has started to spread.
„Uznapredovano“ znači da se rak počeo širiti.
The European Commission granted a marketing authorisation valid throughout the European Union for Inlyta on 3 September 2012.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Inlyta na snazi u Europskoj uniji od 3. rujna 2012.
The dose can be adjusted according to the patient's response.
Doza se može prilagoditi u skladu s odgovorom bolesnika.
The main measure of effectiveness was how long the patients lived without their tumour getting worse.
Glavna mjera djelotvornosti bilo je koliko su dugo bolesnici živjeli bez pogoršanja tumora.
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.
Vezano uz sigurnost lijeka, nuspojave lijeka slične su kao i u drugih lijekova iste klase i smatraju se prihvatljivima i upravljivima.
The recommended starting dose is 5 mg twice a day, taken approximately 12 hours apart.
Preporučena početna doza iznosi 5 mg dva puta na dan, koja se uzima otprilike u razmaku od 12 sati.
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.
U bolesnika koji dobro podnose dozu od 5 mg, koji nemaju visoki krvni tlak i ne uzimaju lijekove za krvni tlak, doza se smije povećati prvo na 7 mg, a zatim maksimalno na 10 mg dva puta na dan.
It may be necessary to reduce the dose or interrupt treatment to manage certain side effects.
Smanjivanje doze ili prekidanje liječenja može biti potrebno kako bi se moglo upravljati određenim nuspojavama.
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.
Najčešće nuspojave lijeka Inlyta (zabilježene u više od 20% bolesnika) su proljev, hipertenzija (visoki krvni tlak), iscrpljenost (umor), disfonija (poremećaj u govoru), mučnina (osjećaj slabosti), povraćanje, smanjeni apetit, gubitak tjelesne težine, palmarno-plantarna eritrodizestezija (osip i utrnuće dlanova i tabana), hemoragija (krvarenje), hipotireoidizam (smanjena funkcija štitnjače), protein u urinu, kašalj i konstipacija.
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.
Bolesnici koji su uzimali lijek Inlyta živjeli su prosječno 6,7 mjeseca bez da se njihova bolest pogoršavala, u usporedbi s 4,7 mjeseci u bolesnika koji su primali sorafenib.
What measures are being taken to ensure the safe and effective use of Inlyta?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Inlyta?
In patients taking certain other medicines, the doctor may need to adjust the dose of Inlyta.
U slučaju bolesnika koji uzimaju određene druge lijekove, liječnik mora prilagoditi dozu lijeka Inlyta.
Patients with moderately reduced liver function should receive a starting dose of 2 mg twice a day.
Bolesnici s umjereno smanjenom funkcijom jetre trebaju primiti manju početnu dozu od 2 mg dva puta na dan.
This is a summary of the European public assessment report (EPAR) for Inlyta.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Inlyta.
Other information about Inlyta
Ostale informacije o lijeku Inlyta
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.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Inlyta.
A risk management plan has been developed to ensure that Inlyta is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Inlyta.
Inlyta should not be used in patients with severely reduced liver function.
Lijek Inlyta ne smiju uzimati bolesnici s ozbiljno smanjenom funckijom jetre.
Effects were better for those patients who were previously treated with cytokines rather than sunitinib.
Djelovanje je bilo bolje u bolesnika koji su prethodno liječeni citokinima, a ne sunitinibom.
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.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Inlyta nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Inlyta is a medicine that contains the active substance axitinib.
Inlyta je lijek koji sadrži djelatnu tvar aksitinib.
What is the risk associated with Inlyta?
Koji su rizici povezani s lijekom Inlyta?
What is Inlyta?
Što je Inlyta?
Why has Inlyta been approved?
Zašto je Inlyta odobrena?
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.
Djelatna tvar lijeka Inlyta, aksitinib, djeluje inhibirajući određene enzime poznate pod nazivom tirozin kinaze koji su prisutni u receptorima krvožilnog endotelnog faktora rasta (VEGFR) na površini stanica raka.
The CHMP therefore decided that Inlyta's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je odlučio da koristi od lijeka Inlyta nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenje za stavljanje lijeka u promet.
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.
Inhibirajući ove receptore, Inlyta pomaže pri usporavanju rasta i širenju raka, te prekida isporuku krvi koja potiče rast stanica raka.
Treatment with Inlyta should be started by doctors who have experience in using cancer medicines.
Liječenje lijekom Inlyta treba započeti liječnik iskusan u primjeni lijekova protiv raka.
VEGF receptors are involved in the growth and spread of cancer cells and in the development of blood vessels that supply the tumours.
Receptori VEGF-a uključeni su u rast i širenje stanica raka, te u razvoj krvnih žila koje opskrbljuju tumore.
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.
Inlyta je uspoređen sa sorafenibom (drugim lijekom protiv raka) u jednom glavnom ispitivanju koje je obuhvatilo 723 bolesnika s uznapredovalim karcinomom bubrežnih stanica čije prethodno liječenje sunitinibom ili citokinima nije bilo uspješno.
The full EPAR for Inlyta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Inlyta nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Inlyta pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
Inlyta is used when treatment with Sutent (sunitinib) or ‘cytokines' (other cancer medicines) has failed.
Inlyta se koristi nakon prethodnog neuspješnog liječenja lijekom Sutent (sunitinib) ili „citokinima” (drugim lijekovima protiv raka).
Inlyta was more effective than sorafenib in treating advanced renal cell carcinoma.
Inlyta je bio djelotvorniji od sorafeniba u liječenju uznapredovalog karcinoma bubrežnih stanica.
Inlyta is used to treat adults with advanced renal cell carcinoma, a type of kidney cancer.
Inlyta se koristi za liječenje odraslih osoba s uznapredovalim karcinomom bubrežnih stanica, tipom raka bubrega.
What is Inlyta used for?
Za što se Inlyta koristi?
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.
CHMP je zaključio da je dokazana djelotvornost lijeka Inlyta u liječenju bolesnika s uznapredovalim karcinomom bubrežnih stanica nakon neuspješnog liječenja lijekom Sutent ili citokinom.
For the full list of all side effects and restrictions with Inlyta, see the package leaflet.
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Inlyta potražite u uputi o lijeku.
How is Inlyta used?
Kako se Inlyta koristi?
What benefit has Inlyta shown during the studies?
Koje su koristi lijeka Inlyta utvrđene u ispitivanjima?
How has Inlyta been studied?
Kako je Inlyta ispitivana?
Partial onset seizures
Djelomični napadi
Renal angiomyolipoma
Renalni angiomiolipomi
This was switched to a full marketing authorisation on 16 November 2015.
To je odobrenje pretvoreno u potpuno odobrenje za stavljanje u promet 16. studenoga 2015.
As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full authorisation.
Budući da je tvrtka dostavila potrebne dodatne informacije, uvjetno odobrenje pretvoreno je u potpuno odobrenje.
It involved 366 adults and children 2 years of age and over.
Ispitivanjem je bilo obuhvaćeno 366 odraslih osoba i djece u dobi od dvije godine i starijih.
This overview was last updated in 04-2018.
Pregled informacija posljednji je put ažuriran u 4. 2018.
The Agency therefore concluded that the benefits of Votubia outweigh its risks and recommended that it be given marketing authorisation.
Agencija je stoga zaključila da koristi od lijeka Votubia nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenje za stavljanje u promet.
What measures are being taken to ensure the safe and effective use of Votubia?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Votubia?
Other information about Votubia
Ostale informacije o lijeku Votubia
Votubia was originally given ‘conditional authorisation' because there was more evidence to come about the medicine, in particular its long-term effects.
Za lijek Votubia prvotno je izdano „uvjetno odobrenje” jer su se očekivali dodatni podatci o lijeku, pogotovo o njegovim dugotrajnim učincima.
If patients experience severe side effects the doctor may need to reduce the dose or interrupt treatment temporarily.
Ako bolesnik iskusi ozbiljne nuspojave, liječnik će možda trebati smanjiti dozu ili privremeno obustaviti liječenje.
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.
Dostupan je u obliku tableta (od 2,5, 5 i 10 mg) i tableta za oralnu suspenziju (od 1, 2, 3 i 5 mg) koje se uzima jednom dnevno u isto doba dana, uvijek uz jelo ili uvijek između obroka.
Votubia is used for partialonset seizures (seizures that start in one part of the brain), which may or may not spread to affect the whole brain (secondary generalisation).
Votubia se koristi kod djelomičnih napada (napada koji započnu u jednom dijelu mozga) koji se mogu ili ne moraju proširiti na cijeli mozak (sekundarna generalizacija).
What is Votubia and what is it used for?
Što je Votubia i za što se koristi?
Further information on Votubia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Više informacija o lijeku Votubia nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Why is Votubia authorised in the EU?
Zašto je lijek Votubia odobren u EU-u?
In patients with renal angiomyolipoma, the recommended dose is 10 mg once a day.
U bolesnika s renalnim angiomiolipomima preporučena doza je 10 mg jednom dnevno.
Side effects reported with Votubia are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Votubia pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
An overview of Votubia and why it is authorised in the EU
Pregled informacija o lijeku Votubia i zašto je odobren u EU-u
The most common side effects with Votubia (seen in more than 1 in 10 patients) are acne, stomatitis (inflammation of the lining of the mouth), upper respiratory tract infections (colds), nasopharyngitis (inflammation of the nose and throat), sinusitis (inflammation of the sinuses), cough, pneumonia (infection of the lung), urinary tract infection, increased blood levels of cholesterol, irregular menstruation (periods), amenorrhoea (absence of periods), headache, diarrhoea, vomiting, rash, tiredness, fever and decreased appetite.
Najčešće nuspojave lijeka Votubia (zabilježene u više od 1 na 10 bolesnika) su akne, stomatitis (upala sluznice usne šupljine), infekcije gornjih dišnih puteva (prehlade), nazofaringitis (upala nosa i grla), sinusitis (upala sinusa), kašalj, upala pluća (infekcija pluća), upala mokraćovoda, povišene razine kolesterola u krvi, neredovite menstruacije (mjesečna krvarenja), amenoreja (izostanak menstruacije), glavobolja, proljev, povraćanje, osip, umor, vrućica i smanjeni apetit.
Votubia received a conditional marketing authorisation valid throughout the EU on 2 September 2011.
Za lijek Votubia izdano je uvjetno odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 2. rujna 2011.
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.
Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Votubia nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Votubia have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Votubia nalaze se u sažetku opisa svojstava i u uputi o lijeku.
In renal angiomyolipoma caused by tuberous sclerosis, Votubia has been compared with placebo in one study involving 118 adults.
Kod renalnih angiomiolipoma uzrokovanih tuberoznom sklerozom, lijek Votubia uspoređen je s placebom u jednom ispitivanju koje je uključivalo 118 odraslih osoba.
Votubia contains the active substance everolimus.
Votubia sadrži djelatnu tvar everolimus.
Votubia treatment should be started by a doctor experienced in treating tuberous sclerosis and in monitoring levels of medicine in the blood.
Terapiju lijekom Votubia treba započeti liječnik s iskustvom u liječenju tuberozne skleroze i nadziranju razina lijeka u krvi.
Votubia must not be used in people who are hypersensitive (allergic) to everolimus, to related medicines such as sirolimus and temsirolimus or to any of the other ingredients.
Lijek Votubia ne smije se primjenjivati u osoba koje su preosjetljive (alergične) na everolimus, na srodne lijekove kao što su sirolimus i temsirolimus ili na bilo koji drugi sastojak lijeka.
What are the risks associated with Votubia?
Koji su rizici povezani s lijekom Votubia?