natgillin/translations-raw huggingface dataset:
As granisetron is metabolised by hepatic cytochrome P450 active substance-metabolising enzymes (CYP1A1 and CYP3A4), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of granisetron.
Ker granisetron presnavljajo encimi citokroma P450 v jetrih, ki presnavljajo učinkovine (CYP1A1 in CYP3A4), lahko spodbujevalci ali zaviralci teh encimov spremenijo očistek in s tem razpolovni čas granisetrona.
Bend the transdermal patch in the middle and remove one half of the rigid plastic film.
Upognite transdermalni obliž v sredini in odstranite eno polovico čvrste plastične podloge.
- However, the transdermal patch may become partially unstuck.
Se pa transdermalni obliž lahko deloma odlepi.
It is not known how activities such as swimming, strenuous exercise or using a sauna or whirlpool, may affect this medicine.
Ni znano, kako bi nekatere dejavnosti, na primer plavanje, naporna vadba ali uporaba savne ali masažnih bazenov, utegnile vplivati na to zdravilo.
Based on the measure of residual content of the transdermal patch after removal, approximately 65% of granisetron is delivered resulting in an average daily dose of 3.1 mg per day.
Če za merilo uporabimo rezidualno vsebnost transdermalnega obliža po odstranitvi, se v telo absorbira okrog 65 % granisetrona, kar pomeni povprečni odmerek 3,1 mg na dan.
In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron and benzodiazepines (lorazepam), neuroleptics (haloperidol) or anti-ulcer medicinal products (cimetidine).
V študijah na zdravih preiskovancih niso našli znakov medsebojnega delovanja med granisetronom in benzodiazepini (lorazepam), nevroleptiki (haloperidol) ali zdravili proti želodčni razjedi (cimetidin).
The active substance in SANCUSO is granisetron, which belongs to a group of medicines called antiemetics and antinauseants.
Učinkovina v zdravilu SANCUSO je granisetron, ki pripada skupini zdravil, ki se imenujejo antiemetiki in zdravila proti slabosti.
Following consecutive application of two SANCUSO transdermal patches in healthy subjects, each for seven days, granisetron levels were maintained over the study period with evidence of minimal accumulation.
Po zaporedni uporabi dveh transdermalnih obližev zdravila SANCUSO pri zdravih osebah, vsakega za sedem dni, se je koncentracija granisetrona v času opazovanja vzdrževala z znaki minimalnega kopičenja.
Skin reactions at the site of application, such as irritation, itching or redness are uncommon and may affect up to 1 in 100 people.
Kožne reakcije na mestu aplikacije, na primer draženje, srbenje ali rdečina, se pojavljajo občasno, pri 1 od 100 ljudi.
The effect of SANCUSO on QTc interval was specifically evaluated in a blinded, randomised, parallel, placebo and positive (moxifloxacin) controlled thorough QTc trial with SANCUSO in 240 adult male and female subjects.
Učinek zdravila SANCUSO na interval QTc so posebej ocenili v slepem, randomiziranem, vzporednem, temeljitem preskušanju QTc, kontroliranim s placebom in pozitivno kontrolo (moksifloksacin), z zdravilom SANCUSO pri 240 odraslih preiskovankah in preiskovancih.
Although, the clinical relevance of this finding is not completely clear, patients should be advised to cover the transdermal patch application site if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal (see section 4.4).
Čeprav klinični pomen te ugotovitve ni popolnoma jasen, je treba bolnikom svetovati, naj mesto uporabe transdermalnega obliža pokrivajo, če obstaja nevarnost izpostavljanja sončni svetlobi, in sicer ves čas obdobja nošenja obliža in še 10 dni po njegovi odstranitvi (glejte poglavje
Do not use this medicine if you are pregnant unless your doctor has specifically recommended it. Stop breast-feeding while wearing the patch.
Ne uporabljajte tega zdravila, če ste noseči, razen če vam ga je vaš zdravnik posebej priporočil.
Assessment of serial ECGs in patients showed no QT prolongation and no change in ECG morphology.
Pregled zaporednih EKG-jev pri bolnikih ni pokazal niti podaljšanja intervala QT niti sprememb morfologije EKG.
There are no data on the use of granisetron in pregnant women.
O uporabi granisetrona pri nosečnicah ni podatkov.
While application of the heat pad was associated with a minor and transient increase in the transdermal patch flux during the period of heat pad application, no overall increase in granisetron exposure was observed when compared to a control group.
Medtem ko je bila uporaba ogrevalne blazine povezana z manjšim prehodnim zvečanjem toka zdravila iz transdermalnega obliža v obdobju uporabe ogrevalne blazine, niso opazili nikakršnega celotnega zvečanja izpostavljenosti granisetronu v primerjavi s kontrolno skupino.
Oral granisetron was administered daily for the duration of the chemotherapy regimen, one hour prior to each dose of chemotherapy.
Peroralni granisetron so dajali vsak dan v času trajanja kemoterapevtske sheme, eno uro pred vsakim odmerkom kemoterapije.
Backing layer Polyester
Podloga poliester
What you need to know before you use SANCUSO Do not use SANCUSO:
Kaj morate vedeti, preden boste uporabili zdravilo SANCUSO Ne uporabljajte zdravila SANCUSO
If required, use surgical bandages or medical adhesive tape to keep the transdermal patch in place.
Če je potrebno, za pritrditev transdermalnega obliža uporabite kirurško obvezo ali medicinski lepilni trak.
Patients who are being treated with moderately or highly emetogenic chemotherapy may still experience vomiting despite treatment with antiemetic therapy, including SANCUSO.
Pri bolnikih, ki se zdravijo z zmerno ali močno emetogeno kemoterapijo, se lahko še vedno pojavlja bruhanje kljub zdravljenju z antiemetiki, med drugim tudi z zdravilom SANCUSO.
Try to avoid wearing the transdermal patch in water for long periods of time.
Ne nosite transdermalnega obliža v vodi dalj časa.
There is no clinical trial experience with SANCUSO and patients on chemotherapy for less than 3 consecutive days, or over multiple cycles of chemotherapy, or with high-dose chemotherapy prior to stem-cell transplantation.
Ni izkušenj iz kliničnih preskušanj z zdravilom SANCUSO pri bolnikih, ki so prejemali kemoterapijo manj kot 3 zaporedne dni ali so prejeli več ciklov kemoterapije oziroma visoke odmerke kemoterapije pred presaditvijo matičnih celic.
When tested for potential photogenotoxicity in vitro in a Chinese hamster ovary (CHO) cell line, granisetron increased the percentage of cells with chromosome damage following photoirradiation.
Pri testiranju glede možne fotogenotoksičnosti in vitro na celični liniji ovarija kitajskega hrčka (CHO) je granisetron zvečal odstotni delež celic z okvarami kromosomov po fotoiradiaciji.
In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of granisetron.
V kliničnih študijah medsebojnega delovanja aprepitant ni imel klinično pomembnih učinkov na farmakokinetiko granisetrona.
In particular, tell your doctor or nurse if you are taking the following medicines: - Paracetamol, used to treat pain.
Še posebno povejte svojemu zdravniku ali farmacevtu, če jemljete naslednja zdravila: - paracetamol, ki se uporablja za blaženje bolečine, - fenobarbital, ki se uporablja za zdravljenje epilepsije, - ketokonazol, ki se uporablja za zdravljenje glivičnih okužb.
After removing the transdermal patch
Po odstranitvi transdermalnega obliža
If this is not possible, a new transdermal patch should be applied on the opposite arm.
Če to ni mogoče, je treba nov transdermalni obliž namestiti na drugo nadlaket.
Fold the used transdermal patch in half with the sticky side inwards and dispose of it safely, out of the reach of children.
Prepognite rabljeni transdermalni obliž na pol z lepljivo stranjo navznoter in ga varno zavrzite, zunaj dosega otrok.
If reattachment is not possible or the transdermal patch is damaged, a new transdermal patch should be applied in the same position as the original transdermal patch.
Če obliža ni mogoče spet pritrditi ali če je poškodovan, je treba na isto mesto kot originalni transdermalni obliž nalepiti nov transdermalni obliž.
After removing the transdermal patch you may find some sticky material is left on your skin.
Po odstranitvi transdermalnega obliža lahko opazite, da je na koži ostalo nekaj lepljive snovi.
Population PK modelling has confirmed the absence of a gender effect on the pharmacokinetics of SANCUSO.
Modeliranje populacijske farmakokinetike je potrdilo odsotnost vpliva spola na farmakokinetiko zdravila SANCUSO.
In a clinical study no differences were seen in the plasma pharmacokinetics of SANCUSO in male and female elderly subjects (≥ 65 years) compared with younger subjects (aged 18-45 years inclusive).
V klinični študiji niso našli nobenih razlik v plazemski farmakokinetiki zdravila SANCUSO pri starejših osebah (≥ 65 let) obeh spolov v primerjavi z mlajšimi preiskovanci (starimi 18 do vključno 45 let).
Pharmacological studies have demonstrated that granisetron is effective against nausea and vomiting as a result of cytostatic therapy.
Farmakološke študije so pokazale, da granisetron učinkuje proti navzei in bruhanju, ki sta posledica citostatične terapije.
The transdermal patch is contained in a sachet.
Transdermalni obliž je pakiran v vrečici.
Due to the gradual increase in plasma levels of granisetron following application of the transdermal patch, initial plasma levels at the start of chemotherapy may be lower than 2 mg oral granisetron and a slower onset of efficacy may therefore be observed.
Zaradi postopnega naraščanja plazemske koncentracije granisetrona po namestitvi transdermalnega obliža so lahko začetne koncentracije granisetrona v plazmi v začetku kemoterapije nižje kot pri 2miligramskem peroralnem granisetronu in zato lahko opažamo počasnejši nastop učinkovitosti.
Breast-feeding should be discontinued during treatment with SANCUSO.
Med zdravljenjem z zdravilom SANCUSO je treba prenehati z dojenjem.
What SANCUSO is and what it is used for What you need to know before you use SANCUSO How to use SANCUSO
Kaj je zdravilo SANCUSO in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo SANCUSO Kako uporabljati zdravilo SANCUSO Možni neželeni učinki
Side effects with a frequency not known (cannot be estimated from available data): - allergic skin reactions.
Neželeni učinki z neznano pogostnostjo (ni je mogoče oceniti iz razpoložljivih podatkov) so:
Anti-emetic activity was assessed from the first administration until 24 hours after the start of the last day's administration of the ME or HE chemotherapy regimen.
Antiemetično učinkovitost so ocenjevali od prvega odmerka do 24 ur po začetku dajanja ME ali HE kemoterapevtske sheme zadnjega dne.
It is unknown whether granisetron or its metabolites are excreted in human milk.
Ni znano, ali se granisetron/presnovki izločajo v materino mleko.
In a study designed to assess the effect of heat on the transdermal delivery of granisetron from SANCUSO in healthy subjects, a heat pad generating an average temperature of 42°C was applied over the transdermal patch for 4 hours each day over the 5 day period of wear.
V študiji, zasnovani za ocenjevanje vpliva toplote na transdermalno prejeti odmerek granisterona iz zdravila SANCUSO pri zdravih preiskovancih, so na transdermalni obliž namestili ogrevalno blazino, ki je generirala povprečno temperaturo 42 °C za 4 ure na vsakega od 5 dni, toliko dolgo so preiskovanci nosili obliž.
There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone, but mostly in combination with other serotonergic medicinal products (including selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitors (SNRIs).
O serotoninskem sindromu so poročali pri uporabi antagonistov 5-HT3 samih, predvsem pa v kombinaciji z drugimi serotoninergičnimi zdravili (vključno s selektivnimi zaviralci ponovnega privzema serotonina (SSRI) ter zaviralci ponovnega privzema serotonina in noradrenalina (SNRI)).
Remove the transdermal patch and tell your doctor if you notice a serious skin reaction (if your skin is very red, itchy or you notice any blisters).
Odstranite transdermalni obliž in obvestite svojega zdravnika, če opazite resno kožno reakcijo (če koža postane močno rdeča, srbeča ali opazite kakšne mehurje).
In clinical studies conducted with SANCUSO, clearance in cancer patients was shown to be approximately half that of healthy subjects.
V kliničnih študijah, opravljenih z zdravilom SANCUSO, je bil očistek pri bolnikih z rakom približno dvakrat manjši kot pri zdravih preiskovancih.
- There is no information on the effect on the transdermal patch of activities such as strenuous exercise or the use of sauna or whirlpools; therefore, you should avoid these activities while wearing this transdermal patch.
- Ni podatkov o vplivu (fizičnih) aktivnosti, kot so na primer naporna vadba ali uporabe savne ali masažnih bazenov, na transdermalni obliž; zato se takrat, ko nosite obliž, izogibajte tem dejavnostim.
Alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased
Bolezni jeter, žolčnika in žolčevodov zvišana alanin-aminotransferaza, zvišana aspartat-aminotransferaza, zvišana gama-glutamiltransferaza občasni
In patients with hepatic impairment due to neoplastic liver involvement, total plasma clearance was approximately halved compared to patients without hepatic impairment.
Pri bolnikih z okvaro jeter zaradi neoplastične prizadetosti jeter je bil celoten plazemski očistek v primerjavi z bolniki brez okvare jeter približno dvakrat manjši.
Co-administration of intravenous 5-HT3 receptor antagonists with oral paracetamol in human subjects has been reported to result in a block in the analgesic effect via a pharmacodynamic mechanism.
Poročali so, da pri preiskovancih sočasno intravensko dajanje antagonistov 5-HT3 s peroralnim paracetamolom povzroči blokiranje analgetičnega učinka preko farmakodinamskega mehanizma.
SANCUSO is a transdermal (skin) patch used to prevent nausea (feeling sick) and vomiting (being sick) in adults receiving chemotherapy treatments (medicines to treat cancer) lasting 3 to 5 days and who have difficulty swallowing tablets (for example due to soreness, dryness or inflammation of the mouth or throat).
Zdravilo SANCUSO je transdermalni (kožni) obliž in se uporablja za preprečevanje navzee (siljenja na bruhanje) in bruhanja pri odraslih, ki prejemajo terapijo s kemoterapevtiki (zdravil za zdravljenje raka), v trajanju od 3 do 5 dni, in le stežka požirajo tablete (ker imajo usta ali žrelo na primer občutljivo, suho ali vneto).
- The other ingredients are: - Transdermal patch adhesive: acrylate-vinylacetate copolymer - Backing layer: polyester - Rigid plastic film: siliconised polyester
- Druge sestavine zdravila so: - Lepilo transdermalnega obliža: akrilno-vinilacetatni kopolimer - Podloga: poliester - Čvrsta plastična podloga: silikonizirani poliester
Remove the second half of the rigid plastic film and press the whole transdermal patch firmly in place with your fingers and smooth down.
Odstranite drugo polovico čvrste plastične podloge in čvrsto pritisnite ves transdermalni obliž na izbrano mesto s prsti in ga zgladite.
- if you are allergic to granisetron or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to any other anti-sickness medicines whose name ends in “setron” e.g. ondansetron.
- če ste alergični na granisetron ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če ste alergični na katera koli druga zdravila za preprečevanje siljenju na bruhanje in bruhanja,
In a pharmacokinetic study in healthy volunteers, where SANCUSO was applied for a period of 7 days, mean total exposure (AUC0-infinity) was 416 ng h/ml (range 55 - 1192 ng h/ml), with a between subject variability of 89%.
V farmakokinetični študiji pri zdravih prostovoljcih, ki so jim dajali zdravilo SANCUSO v obdobju 7 dni, je bila srednja celotna izpostavljenost (AUC0-∞) 416 ng h/ml (razpon 55 - 1192 ng h/ml), variabilnost med preiskovanci je bila 89 %.
The medicine in the transdermal patch passes gradually through your skin into your body and, therefore, the patch is applied 1 to 2 days (24 to 48 hours) before the start of chemotherapy treatment.
Učinkovina iz transdermalnega obliža prehaja skozi kožo v telo postopoma, zato je treba namestiti obliž 1 do 2 dni (24 do 48 ur) pred začetkom zdravljenja s kemoterapevtiki.
The area you choose should not be oily, recently shaved or have any skin problems such as being injured (cut or scraped) or irritated (redness or a rash).
Predel, ki ga izberete, naj ne bo masten ali pred nedavnim obrit, na njem naj ne bo kožnih sprememb, na primer poškodb (vreznin ali prask) ali vnetja (rdečina ali izpuščaj).
The effects of gender on the pharmacokinetics of SANCUSO have not been specifically studied.
Vpliva spola na farmakokinetiko zdravila SANCUSO niso posebej proučevali.
It is important to do the following: - while you wear the transdermal patch, keep it covered with clothing if you will be in sunlight or near a sunlamp, including tanning beds - keep the skin where this medicine was applied covered for another 10 days after the transdermal patch is taken off to protect from exposure to direct sunlight.
Pomembno je, da naredite tole: - tačas, ko nosite transdermalni obliž, ga pokrijte z obleko, če boste na soncu, v solariju ali ležečem solariju; - koža, kjer je bil prilepljen obliž s tem zdravilom, naj bo pokrita še 10 dni po odstranitvi obliža,
Showering or washing normally can be continued while wearing SANCUSO.
Bolnik lahko normalno nadaljuje s tuširanjem in z umivanjem, ko uporablja obliž SANCUSO.
It is important to use this medicinal product as instructed by your doctor to prevent you feeling sick or being sick following your chemotherapy.
Pomembno je, da uporabljate to zdravilo tako, kot vam je naročil zdravnik, da vam po kemoterapiji ne bo slabo in ne boste bruhali.
If you forget to use SANCUSO
Če ste pozabili uporabiti zdravilo SANCUSO
SANCUSO transdermal patch is indicated in adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult (see section 5.1).
Transdermalni obliž SANCUSO je indiciran pri odraslih za preprečevanje navzee in bruhanja, ki sta povezana z zmerno ali močno emetogeno kemoterapijo, za katero je predvideno, da traja 3 do 5 zaporednih dni, pri bolnikih, pri katerih je uporaba antiemetikov otežena zaradi dejavnikov, ki otežujejo požiranje (glejte poglavje 5.1).
- When you remove the transdermal patch, check your skin and tell your doctor if you notice a serious skin reaction (if your skin is very red, itchy or you notice any blisters).
- Ko transdermalni obliž odstranite, preglejte kožo in povejte zdravniku, če opazite resno kožno reakcijo (če je koža zelo rdeča, srbeča ali so na njej mehurji).
Things to remember when using the transdermal patch - Do not keep or store the transdermal patch outside the sealed sachet.
Kaj morate vedeti, ko uporabljate transdermalni obliž - Ne hranite transdermalnega obliža zunaj zataljene vrečice.
For serotonergic medicinal products (e.g. SSRIs and SNRIs), there have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicinal products (including SSRIs and SNRIs).
V zvezi s serotoninergičnimi zdravili (npr. zaviralci SSRI in SNRI) so poročali o serotoninskem sindromu po sočasni uporabi antagonistov 5-HT3 z drugimi serotoninergičnimi zdravili (vključno z zaviralci SSRI in SNRI).
Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Zaradi simptomov, podobnih serotoninskemu sindromu, se priporoča ustrezno opazovanje bolnikov.
The granisetron transdermal patch was applied 24 to 48 hours prior to the first dose of chemotherapy, and kept in place for 7 days.
Transdermalni obliž z granisetronom so namestili 24 do 48 ur pred prvim odmerkom kemoterapije in ga pustili na mestu 7 dni.
If you stop using SANCUSO
Če ste prenehali uporabljati zdravilo SANCUSO
Not known
občasni neznana
The study was designed to show non-inferiority of SANCUSO to oral granisetron.
Študija je bila zasnovana tako, da bi pokazala neinferiornost zdravila SANCUSO v primerjavi s peroralnim granisetronom.
No correlation between creatinine clearance and total clearance was observed in cancer patients, indicating no influence of renal impairment on the pharmacokinetics of granisetron.
Med očistkom kreatinina in celotnim očistkom pri bolnikih z rakom niso opazili korelacije, kar kaže, da ledvična okvara ne vpliva na farmakokinetiko granisetrona.
- SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
- Zaviralci SNRI (zaviralci ponovnega privzema serotonina in noradrenalina) se uporabljajo za zdravljenje depresije in/ali anksioznosti ter vključujejo venlafaksin in duloksetin.
Granisetron is cleared primarily by hepatic metabolism.
Granisetron se odstranjuje predvsem s presnovo v jetrih.
The sticky side of the transdermal patch is covered by a two-piece rigid plastic film.
Lepljiva stran transdermalnega obliža je pokrita s čvrsto plastično podlogo iz dveh delov.
If you are being treated with chemotherapy that is moderately or highly capable of making you feel sick, you may still be sick despite treatment with anti-sickness medicine, including this medicine.
Če se zdravite s kemoterapevtiki, ki zmerno ali močno prožijo siljenje na bruhanje in bruhanje, se lahko še vedno pojavlja bruhanje kljub zdravljenju z ustreznimi zdravili, vključno s tem zdravilom.
If the transdermal patch becomes unstuck
Če se transdermalni obliž odlepi
If your arms are not suitable areas to apply the transdermal patch your doctor may ask you to put it on your abdomen.
Če ni primerno, da bi si nalepili transdermalni obliž na zgornji ud, vam bo zdravnik mogoče predlagal, da si ga nalepite na trebuh.
Remove a sachet from the box and tear it open using the slit provided.
Vzemite vrečico iz škatlice in jo raztrgajte po že pripravljeni zarezi.
Application site irritation Application site reactions (application site pain, application site pruritus, application site erythema, application site rash, application site irritation) *
Bolezni kože in podkožja draženje na mestu aplikacije reakcije na mestu aplikacije (bolečina na mestu aplikacije, srbenje na mestu aplikacije, eritem na mestu aplikacije, izpuščaj na mestu aplikacije, draženje na mestu aplikacije)*
No clinically relevant interactions between SANCUSO and emetogenic cancer chemotherapies have been seen.
Klinično pomembnih interakcij med zdravilom SANCUSO in emetogenimi kemoterapevtiki za zdravljenje raka niso ugotovili.
Apply a single transdermal patch 24 to 48 hours before chemotherapy, as appropriate.
Namestite en transdermalni obliž 24 do 48 ur pred kemoterapijo, kot je pač potrebno.
As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration.
Granisetron lahko zmanjša motiliteto spodnjega dela črevesa, zato moramo spremljati bolnike z znaki subakutne obstrukcije črevesa po uporabi granisetrona.
The transdermal patch may be applied up to a maximum of 2 days (48 hours) before chemotherapy.
Transdermalni obliž si lahko nalepite do največ 2 dni (48 ur) pred kemoterapijo.
Transdermal use.
transdermalna uporaba
Concurrent administration of a single intravenous bolus of 0.01 mg/kg (maximum 1 mg) granisetron at the same time a SANCUSO transdermal patch was applied was investigated in healthy subjects.
Pri zdravih preiskovancih so raziskali dajanje enega intravenskega bolusa po 0,01 mg/kg (največji odmerek 1 mg) granisetrona sočasno z aplikacijo transdermalnega obliža zdravila SANCUSO.
Adverse reactions from clinical studies and spontaneous reports with SANCUSO are listed in the table below.
Neželeni učinki iz kliničnih študij in spontana poročila o neželenih učinkih zdravila SANCUSO so navedeni v spodnji preglednici.