natgillin/translations-raw huggingface dataset:
If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of extrapyramidal symptoms (e.g. tremor) in patients with dementia associated with Parkinson's disease are observed during treatment, these may respond to omitting one or more doses.
Če se pri bolnikih z demenco, povezano s Parkinsonovo boleznijo med zdravljenjem pojavijo neželeni učinki (npr. navzea, bruhanje, bolečine v trebuhu ali izguba apetita), če se zmanjša telesna masa ali če se poslabšajo ekstrapiramidni simptomi, (npr. tremor), bo morda treba izpustiti en ali več odmerkov.
If the dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day.
Če po najmanj dveh tednih zdravljenja bolniki odmerek dobro prenašajo, se lahko poveča na 3 mg dvakrat na dan. Tudi nadaljnje povečanje odmerka na 4,5 mg in nato na
The use of this medicinal product is contraindicated in patients with - hypersensitivity to the active substance, other carbamate derivatives or to any of the excipients
- s preobčutljivostjo za zdravilno učinkovino, druge derivate karbamata ali katero koli pomožno snov
Always take Rivastigmine Teva exactly as your doctor has told you.
Pri jemanju zdravila Rivastigmine Teva vedno upoštevajte zdravnikova navodila.
No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
varfarinom, diazepamom ali fluoksetinom niso opazili.
Capsule contents Microcrystalline cellulose Hypromellose Colloidal silicon dioxide
Vsebina kapsule: mikrokristalna celuloza hipromeloza koloidni silicijev dioksid magnezijev stearat
- If you are allergic (hypersensitive) to rivastigmine (the active substance in Rivastigmine Teva)
- če ste alergični (preobčutljivi) na rivastigmin (zdravilno učinkovino v zdravilu Rivastigmine Teva) ali katero koli sestavino zdravila Rivastigmin Teva, ki je navedena v poglavju 6 tega navodila za
Fall
Padci
Uncommon • Uneven heartbeat and poor control of movements
Občasni • nepravilen srčni utrip in motnje koordinacije gibov
White cap imprinted with “R” & white body imprinted with “1.5”
Trda kapsula Bela kapa z natisnjenim napisom »R« in belo telo z natisnjenim napisom »1.5«.
• Fainting or accidentally falling
• omedlevica ali nezgodni padci • spremembe v delovanju jeter
Renal and hepatic impairment:
Ledvična in jetrna okvara:
The mean actual daily dose for responders in the 6-12 mg group, corresponding to this definition, was 9.3 mg.
Povprečni dejanski dnevni odmerek med bolniki, ki so se po tej opredelitvi odzvali na zdravljenje, v skupini, ki je prejemala 6-12 mg, je bil 9,3 mg. Pomembno je vedeti, da se lestvice, ki se uporabljajo pri tej indikaciji, razlikujejo, in da neposredno primerjanje rezultatov pri različnih terapevtskih učinkovinah ni primerno.
- if you have, or have ever had, impaired liver function.
- če imate ali ste kadarkoli imeli okvarjeno delovanje ledvic,
HOW TO STORE RIVASTIGMINE TEVA
Kaj vsebuje zdravilo Rivastigmine Teva
The Cmax of rivastigmine was approximately 60 % higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
vrednost AUC rivastigmina pa več kot dvakrat večja, kot pri zdravih osebah.
PSURs
PSURi
Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level.
6 mg dvakrat na dan mora temeljiti na prenašanju trenutnega odmerka, poveča pa se lahko po najmanj dveh tednih zdravljenja s prejšnjim odmerkom.
Ink used for imprinting - Black S-1-17822/S-1-17823
rumeni železov oksid (E 172) titanov dioksid (E 171) želatina črnilo za tisk - črno S-1-17822/S-1-17823
Therefore, the ability of patients with dementia on rivastigmine to continue driving or operating complex machines should be routinely evaluated by the treating physician.
Lečeči zdravnik mora zato rutinsko ocenjevati sposobnost bolnikov z demenco, ki jemljejo rivastigmin za vožnjo in upravljanje s stroji.
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.. Rivastigmine Teva may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.If you feel dizzy or sleepy do not drive, use machines or perform any tasks that require your attention.
Zdravnik vam bo povedal, ali vam vaša bolezen dovoljuje, da varno upravljate vozila in uporabljate stroje.
Skin and subcutaneous tissue disorders Common
Bolezni kože in podkožja Pogosti
Elderly subjects:
Starejše osebe:
- if you have, or have ever had, irregular heartbeat.
- če imate ali ste kadarkoli imeli nereden srčni utrip,
or to any of the other ingredients of Rivastigmine Teva listed in section 6 of this leaflet - If this applies to you, tell your doctor and do not take Rivastigmine Teva.
- Če kaj od navedenega velja za vas, povejte svojemu zdravniku in ne jemljite zdravila Rivastigmine
ITT + RDO population
Populacija ITT + RDO (n = 329)
Cardiac disorders Common
Občasni Srčne bolezni
General disorders and administration site conditions Common
Splošne težave in spremembe na mestu aplikacije Pogosti
please tell your doctor or pharmacist.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
Mean baseline ± SD
Malta Drugsales Ltd
Hard capsule Orange cap imprinted with “R” & flesh color body imprinted with “6”
Trda kapsula Kapa oranžne barve z natisnjenim napisom »R« in telo svetlo rjave barve z natisnjenim napisom »6«.
Rash
ŠS
Repeated-dose toxicity studies in rats, mice and dogs revealed only effects associated with an exaggerated pharmacological action.
5.3 Predklinični podatki o varnosti Študije toksičnosti pri ponavljajočih se odmerkih pri podganah, miših in psih so pokazale samo učinke,
NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 1.5 mg hard capsules
IME ZDRAVILA Rivastigmine Teva 1,5 mg trde kapsule
Rivastigmine Teva 1.5 mg hard capsules
Rivastigmine Teva 1,5 mg trde kapsule rivastigmin
Vascular Disorders Very rare
Infekcijske in parazitske bolezni Zelo redki
Rivastigmine Teva 4.5 mg hard capsules
Rivastigmine Teva 4,5 mg trde kapsule rivastigmin
Table 2 shows the adverse reactions reported in patients with dementia associated with Parkison's disease treated with rivastigmine.
V tabeli 2 so prikazani neželeni učinki, o katerih so poročali pri bolnikih z demenco, povezano s
• Severe confusion
• hujšanje
Fits (seizures)
• napadi krčev (epileptični napadi)
BATCH NUMBER BN
ŠTEVILKA SERIJE ŠS
NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 4.5 mg hard capsules Rivastigmine
IME ZDRAVILA Rivastigmine Teva 4,5 mg trde kapsule
B. CONDITIONS OF THE MARKETING AUTHORISATION
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 6 mg hard capsules Rivastigmine
IME ZDRAVILA Rivastigmine Teva 6 mg trde kapsule
NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 3 mg hard capsules Rivastigmine
IME ZDRAVILA Rivastigmine Teva 3 mg trde kapsule
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 4.5 mg
Vsaka kapsula vsebuje rivastigminhidrogentartrat, kar ustreza 4,5 mg rivastigmina.
- Rivastigmine Teva 4.5 mg hard capsules: Orange colour cap imprinted with “R” & orange
- Rivastigmine Teva 4,5 mg trde kapsule: kapa oranžne barve z natisnjenim napisom »R« in telo oranžne barve z natisnjenim napisom »4,5«.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet container - Self-adhesive, paper label - Rivastigmine Teva 6 mg hard capsules
Vsebnik s tabletami - samolepilna papirna oznaka - Rivastigmine Teva 6 mg trde kapsule
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet Container - Self-adhesive, paper label - Rivastigmine Teva 4.5 mg hard capsules
Vsebnik s tabletami - samolepilna papirna oznaka - Rivastigmine Teva 4,5 mg trde kapsule
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet container - Self-adhesive, paper label - Rivastigmine Teva 1.5 mg hard capsules
Vsebnik s tabletami - samolepilna papirna oznaka - Rivastigmine Teva 1,5 mg trde kapsule
BN
V
Gastrointestinal disorders Very common Very common Very common Common
Žilne bolezni Zelo redki Bolezni prebavil Zelo pogosti Zelo pogosti Zelo pogosti Pogosti
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet container - Self-adhesive, paper label - Rivastigmine Teva 3 mg hard capsules
Vsebnik s tabletami - samolepilna papirna oznaka - Rivastigmine Teva 3 mg trde kapsule
Not known • Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with
• močno bruhanje, ki lahko povzroči raztrganje požiralnika (cevi med usti in želodcem)
Weight loss
Izguba telesne mase
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 1.5 mg
Vsaka kapsula vsebuje rivastigminhidrogentartrat, kar ustreza 1,5 mg rivastigmina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - Rivastigmine Teva 6 mg hard capsules
PODATKI NA ZUNANJI OVOJNINI Škatla - Rivastigmine Teva 6 mg trde kapsule
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - Rivastigmine Teva 1.5 mg hard capsules
PODATKI NA ZUNANJI OVOJNINI Škatla - Rivastigmine Teva 1,5 mg trde kapsule
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - Rivastigmine Teva 3 mg hard capsules
PODATKI NA ZUNANJI OVOJNINI Škatla - Rivastigmine Teva 3 mg trde kapsule
- Rivastigmine Teva 6 mg hard capsules: Orange cap imprinted with “R” & flesh colour body
- Rivastigmine Teva 6 mg trde kapsule: kapa oranžne barve z natisnjenim napisom »R« in telo svetlo rjave barve z natisnjenim napisom »6«.
WHAT RIVASTIGMINE TEVA IS AND WHAT IT IS USED FOR The active substance of Rivastigmine Teva is rivastigmine Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
Rivastigmin sodi v skupino učinkovin, ki jih imenujemo zaviralci holinesteraze.
Tell your doctor if you become pregnant during treatment.
Če zanosite v času zdravljenja, obvestite svojega zdravnika.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 6 mg
Vsaka kapsula vsebuje rivastigminhidrogentartrat, kar ustreza 6 mg rivastigmina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - Rivastigmine Teva 4.5 mg hard capsules
PODATKI NA ZUNANJI OVOJNINI Škatla - Rivastigmine Teva 4,5 mg trde kapsule
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 3 mg
Vsaka kapsula vsebuje rivastigminhidrogentartrat, kar ustreza 3 mg rivastigmina.
To be swallowed whole without crushing or opening Read the package leaflet before use.
Kapsule je treba pogoltniti cele, brez drobljenja ali odpiranja.
Pruritus
Presnova
Magnesium stearate
Prekomerno izločanje sline
Adjusted treatment difference n/a p-value versus placebo ITT - LOCF population (n=287)
Populacija ITT + RDO (n = 87)
- Rivastigmine Teva 3 mg hard capsules: Flesh colour cap imprinted with “R” & flesh colour
- Rivastigmine Teva 3 mg trde kapsule: kapa svetlo rjave barve z natisnjenim napisom »R« in telo svetlo rjave barve z natisnjenim napisom »3«.
Parkinson's disease (worsening) Salivary hypersecretion Dyskinesia
Parkinsonova bolezen (poslabšanje)
Gastrointestinal disorders Very common Very common Common
Pogostnost nezanana Bolezni prebavil Zelo pogosti Zelo pogosti Pogosti
To be swallowed whole without crushing or opening Read the package leaflet before use
Če ste omotični ali zaspani, ne vozite, ne uporabljajte strojev in ne izvajajte opravil, ki zahtevajo zbranost.
This dose may also be adjusted.
Ta odmerek se lahko tudi prilagodi.
It is available as capsules (12.5 mg, 25 mg, 37.5 mg and 50 mg).
Na voljo je v obliki kapsul (12,5 mg, 25 mg, 37,5 mg in 50 mg).
What measures are being taken to ensure the safe and effective use of Sutent?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sutent?
This was switched to a full marketing authorisation on 11 January 2007.
To je bilo 11. januarja 2007 spremenjeno v običajno dovoljenje za promet.
The European Commission granted a conditional marketing authorisation valid throughout the European Union for Sutent on 19 July 2006.
Evropska komisija je pogojno dovoljenje za promet z zdravilom, veljavno po vsej Evropski uniji, izdala 19. julija 2006.
This means that it blocks some specific enzymes known as protein kinases.
To pomeni, da zavira določene encime, imenovane proteinske kinaze.
The full EPAR for Sutent 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 Sutent je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Sutent
Druge informacije o zdravilu Sutent
What benefit has Sutent shown during the studies?
Kakšne koristi je zdravilo Sutent izkazalo med študijami?
This is a summary of the European public assessment report (EPAR) for Sutent.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sutent.
A risk management plan has been developed to ensure that Sutent is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Sutent je bil pripravljen načrt obvladovanja tveganj.
Sutent is used to treat adults with the following types of cancer:
Zdravilo Sutent se uporablja za zdravljenje odraslih z naslednjimi vrstami raka:
For more information about treatment with Sutent, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Sutent preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Sutent's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Sutent večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The main measure of effectiveness in all of the studies was how long the patients lived without their tumours getting worse.
V vseh študijah je bilo glavno merilo učinkovitosti čas, v katerem se stanje bolnikovih tumorjev ni poslabšalo.
Sutent is used if the disease is getting worse and the tumour cells are well-differentiated (similar to normal cells in the pancreas).
Zdravilo Sutent se uporablja, kadar se bolezensko stanje poslabšuje in so tumorske celice dobro diferencirane (podobne normalnim celicam trebušne slinavke).
What is the risk associated with Sutent?
Kakšna tveganja so povezana z zdravilom Sutent?
Sutent was originally given ‘conditional approval' because there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
Zdravilo Sutent je prvotno pridobilo „pogojno dovoljenje za promet“, ker so pričakovali še več dokazov o zdravilu, zlasti o njegovi uporabi pri zdravljenju karcinoma ledvičnih celic.
It is used after treatment with imatinib (another cancer medicine) has failed;
Uporablja se po neuspelem zdravljenju z imatinibom (drugim zdravilom za zdravljenje raka);
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sutent, 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.
For the full list of all side effects and restrictions with Sutent, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Sutent glejte navodilo za uporabo.
Sutent is a medicine that contains the active substance sunitinib.
Sutent je zdravilo, ki vsebuje zdravilno učinkovino sunitinib.
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 Sutent.
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.
The active substance in Sutent, sunitinib, is a protein kinase inhibitor.
Zdravilna učinkovina v zdravilu Sutent, sunitinib, je zaviralec proteinske kinaze.
Sutent is used in patients with GISTs that cannot be removed with surgery or have spread to other parts of the body.
Zdravilo Sutent se uporablja pri bolnikih z gastrointestinalnim stromalnim tumorjem, ki ga ni mogoče odstraniti s kirurškim posegom ali pa se je ta razširil v druge dele telesa.
Why has Sutent been approved?
Zakaj je bilo zdravilo Sutent odobreno?
• metastatic renal cell carcinoma, a type of kidney cancer, that has spread to other parts of the body;
• metastatskega karcinoma ledvičnih celic, tj. vrste ledvičnega raka, ki se je razširil v druge dele telesa;
Sutent was also compared with another cancer medicine, interferon alfa, in 750 patients with metastatic renal cell carcinoma whose cancer had not been treated before.
Zdravilo Sutent so primerjali tudi z drugim zdravilom za zdravljenje raka, interferonom alfa, pri 750 bolnikih z metastatskim karcinomom ledvičnih celic, pri katerih zdravljenje raka še ni bilo izvedeno.
These enzymes can be found in some receptors at the surface of cancer cells, where they are involved in the growth and spread of cancer cells and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels.
Ti encimi se nahajajo na nekaterih receptorjih na površini rakavih celic, kjer sodelujejo pri rasti in širjenju rakavih celic, ter v krvnih žilah, ki oskrbujejo tumor in kjer sodelujejo pri nastanku novih krvnih žil.
By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing.
Zdravilo Sutent lahko z zaviranjem teh encimov zavre rast in širjenje raka ter prekine dotok krvi, ki omogoča rast rakavih celic.
For GIST and metastatic renal cell carcinoma, Sutent is given in six-week cycles, at a dose of 50 mg once a day for four weeks, followed by a two-week ‘rest period'.
Pri gastrointestinalnem stromalnem tumorju in metastatskem karcinomu ledvičnih celic se zdravilo Sutent daje v šesttedenskih ciklih, in sicer štiri tedne v odmerku 50 mg enkrat dnevno, čemur sledi dvotedenski premor.
Treatment with Sutent should be started by doctors who have experience in administering cancer medicines.
Zdravljenje z zdravilom Sutent lahko uvede samo zdravnik, ki ima izkušnje z dajanjem zdravil za zdravljenje raka.
• gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel where there is uncontrolled growth of cells in the supporting tissues of these organs.
• gastrointestinalnega stromalnega tumorja (GIST), tj. vrste raka želodca in črevesja, pri katerem celice v opornem tkivu teh organov nenadzorovano rastejo.
Sutent was compared with placebo (a dummy treatment) in 312 patients with GIST whose previous treatment with imatinib had failed and in 171 patients with worsening pancreatic neuroendocrine tumours that could not be removed with surgery.
Zdravilo Sutent so primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 312 bolnikih z gastrointestinalnim stromalnim tumorjem, pri katerih je bilo predhodno zdravljenje z imatinibom neuspešno, in pri 171 bolnikih z nevroendokrinim tumorjem trebušne slinavke, ki se slabša in ki ga ni bilo mogoče odstraniti s kirurškim posegom.
The most common side effects with Sutent (seen in more than 1 in 10 patients) include fatigue (tiredness), gastrointestinal disorders (such as diarrhoea, feeling sick, inflammation of the lining of the mouth, indigestion and vomiting), respiratory (such as shortness of breath and cough) and skin disorders (such as skin discoloration, dryness of the skin and rash), hair color changes, dysgeusia (taste disturbances), epistaxis (nosebleeds), loss of appetite, hypertension (high blood pressure), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), hypothyroidism (an underactive thyroid gland), insomnia (difficulty falling and staying asleep), dizziness, headache, arthralgia (joint pain), neutropenia (low levels of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), and leucopenia (low white blood cell counts).
pomanjkanje teka, epistaksa (krvavitve iz nosu), izguba teka, hipertenzija (visok krvni tlak), sindrom palmarno-plantarne eritrodisestezije (izpuščaji in odrevenelost na dlaneh in stopalih), hipotiroidizem (nezadostno delovanje ščitnice), nespečnost (težave z uspavanjem in zbujanje), omotica, glavobol, artralgija (bolečine v sklepih), nevtropenija (nizka raven nevtrofilcev, vrste belih krvničk), trombocitopenija (nizka raven trombocitov v krvi), anemija (nizka raven rdečih krvničk) in levkopenija (nizka raven belih krvničk).
The most serious side effects reported with Sutent include heart and kidney failure, pulmonary embolism (clot in a blood vessel supplying the lungs), gastrointestinal perforation (holes in the wall of the gut), and internal haemorrhages (bleeding).
Najresnejši neželeni učinki, o katerih so poročali pri zdravilu Sutent, so srčno in ledvično popuščanje, pljučna embolija (strdki v krvnih žilah, ki oskrbujejo pljuča), gastrointestinalne perforacije (luknje v črevesju) in notranje krvavitve.
• pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) that have spread or cannot be removed with surgery.
• nevroendokrinega tumorja trebušne slinavke (tumorja celic trebušne slinavke, ki proizvajajo hormone), ki se je razširil ali pa ga ni mogoče odstraniti s kirurškim posegom.
Sutent was more effective than placebo in treating GIST and pancreatic neuroendocrine tumours.
Zdravilo Sutent je bilo pri zdravljenju gastrointestinalnega stromalnega tumorja in nevroendokrinega tumorja trebušne slinavke učinkovitejše od placeba.
In metastatic renal cell carcinoma, patients taking Sutent lived for an average of 47.3 weeks without their disease worsening, compared with 22.0 weeks in the patients receiving interferon alfa.
Pri bolnikih z metastatskim karcinomom ledvičnih celic, ki so prejemali zdravilo Sutent, je bilo obdobje brez poslabšanja bolezni v povprečju dolgo 47,3 tedna, pri bolnikih, ki so prejemali interferon alfa, pa 22,0 tedna.
Patients with GIST taking Sutent lived for an average of 26.6 weeks without the disease getting worse, compared with 6.4 weeks in the patients taking placebo.
Pri bolnikih z gastrointestinalnim stromalnim tumorjem, ki so prejemali zdravilo Sutent, se bolezen ni poslabšala v povprečju 26,6 tedna, pri bolnikih, ki so prejemali placebo, pa 6,4 tedna.
What is Sutent used for?
Za kaj se zdravilo Sutent uporablja?
How has Sutent been studied?
Kako je bilo zdravilo Sutent raziskano?
For pancreatic neuroendocrine tumours the figures were 11.4 months in the Sutent group and 5.5 months in the placebo group.
Pri bolnikih z nevroendokrinim tumorjem trebušne slinavke, ki so prejemali zdravilo Sutent, je bilo to obdobje dolgo 11,4 meseca, pri tistih, ki so prejemali placebo, pa 5,5 meseca.
How is Sutent used?
Kako se zdravilo Sutent uporablja?
The dose can be adjusted according to the patient's response to the treatment, but should be kept within the range of 25 to 75 mg. For pancreatic neuroendocrine tumours, Sutent is given at a dose of 37.5 mg once a day without a rest period.
Pri nevroendokrinem tumorju trebušne slinavke se zdravilo Sutent daje v odmerku 37,5 mg enkrat na dan brez obdobja premora.
(Invented) name Strength Pharmaceutical Form
Jakost Farmacevtska oblika Pot uporabe
83607 Holzkirchen Germany
25, 83607 Holzkirchen Nemčija
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SANOHEX AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA SANOHEX IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)