natgillin/translations-raw huggingface dataset:
Non-inferiority of SANCUSO versus oral granisetron was confirmed, with complete control (CC) achieved in 60.2% of patients in the SANCUSO arm and 64.8% of patients receiving oral granisetron in the per protocol set (difference -4.89%; 95% confidence interval -12.91% to +3.13%; n=284 transdermal patch, n=298 oral).
Potvrđena je neinferiornost lijeka SANCUSO u usporedbi s peroralnim granizetronom, a potpuna kontrola postignuta je u 60,2% bolesnika u skupini koja je primjenjivala SANCUSO i u 64,8% bolesnika koji su primali peroralni granizetron prema planu ispitivanja (razlika -4,89%; 95%-tni interval pouzdanosti -12,91% do +3,13%; n= 284 transdermalni flaster, n= 298 peroralni granizetron).
After transdermal patch application, the apparent granisetron plasma half-life in healthy subjects was prolonged to approximately 36 hours due to the slow absorption rate of granisetron through the skin.
Nakon primjene transdermalnog flastera, prividni poluvijek granizetrona u plazmi u zdravih ispitanika produžen je na približno 36 sati zbog spore apsorpcije granizetrona kroz kožu.
Pharmacological studies have demonstrated that granisetron is effective against nausea and vomiting as a result of cytostatic therapy.
Farmakološka ispitivanja dokazala su da je granizetron učinkovit protiv mučnine i povraćanja koji su posljedica liječenja citostaticima.
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.
Nema iskustva iz kliničkih ispitivanja s lijekom SANCUSO u bolesnika koji su primali kemoterapiju manje od 3 uzastopna dana ili su primili više ciklusa kemoterapije ili visoke doze kemoterapije prije transplantacije matičnih stanica.
The transdermal patch is contained in a sachet.
Transdermalni flaster nalazi se u vrećici.
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.
U ispitivanju provedenom radi procjenjivanja učinaka topline na transdermalnu primjenu granizetrona putem lijeka SANCUSO u zdravih ispitanika, na transdermalni flaster postavljen je grijaći jastuk koji je proizvodio prosječnu temperaturu od 42°C u trajanju 4 sata svakog dana tijekom 5 dana nošenja.
If required, use surgical bandages or medical adhesive tape to keep the transdermal patch in place.
Ako je potrebno, za pričvršćivanje transdermalnog flastera koristite kirurške zavoje ili medicinsku ljepljivu traku.
Constipation is a common side effect and may affect up to 1 in 10 people.
Zatvor je česta nuspojava i može se javiti u do 1 na 10 osoba.
SANCUSO has no or negligible influence on the ability to drive and use machines.
SANCUSO ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada na strojevima.
Fold the used transdermal patch in half with the sticky side inwards and dispose of it safely, out of the reach of children.
Iskorišteni transdermalni flaster presavijte na pola s ljepljivom stranom prema unutra i bacite ga na siguran način, izvan dohvata djece.
In a clinical study designed to assess granisetron exposure from SANCUSO in subjects with differing levels of body fat, using BMI as a surrogate measure for body fat, no differences were seen in the plasma pharmacokinetics of SANCUSO in male and female subjects with a low BMI [<19.5 kg/m2 (males), <18.5 kg/m2 (females)] and a high BMI (30.0 to 39.9 kg/m2 inclusive) compared to a control group (BMI 20.0 to 24.9 kg/m2inclusive).
U kliničkom ispitivanju provedenom radi procjene izlaganja granizetronu iz lijeka SANCUSO u osoba s različitom količinom tjelesne masnoće, pri čemu je kao nadomjesna mjera za tjelesnu masnoću korišten ITM, nisu uočene razlike u farmakokinetici lijeka SANCUSO u plazmi muških i ženskih ispitanika s niskim ITM [<19,5 kg/m2 (muškarci), <18,5 kg/m2 (žene)] i visokim ITM (30,0 do uključivo 39,9 kg/m2) u usporedbi s kontrolnom skupinom (ITM 20,0 do uključivo 24,9 kg/m2).
If the transdermal patch becomes unstuck
Ako se transdermalni flaster odlijepi
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).
Prijavljeni su slučajevi serotoninskog sindroma s primjenom 5-HT3 antagonista, bilo da je primijenjen sam ili, većinom, u kombinaciji s drugim serotonergičkim lijekovima (uključujući selektivne inhibitore ponovne pohrane serotonina (SSRI) i inhibitore ponovne pohrane serotonina i noradrenalina (SNRI).
Matrix layer Acrylate-vinylacetate copolymer
Matriksni sloj akrilat-vinilacetat kopolimer
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.
Nakon uzastopne primjene dvaju transdermalnih flastera SANCUSO u zdravih ispitanika, pri čemu je svaki nošen 7 dana, koncentracija granizetrona je održana uz minimalnu akumulaciju tijekom ispitivanja.
After removal, the used transdermal patch should be folded firmly in half, adhesive side inwards and then discarded out of the reach of children.
Nakon uklanjanja, iskorišteni transdermalni flaster je potrebno čvrsto presaviti na pola, s ljepljivom stranom prema unutra, i zatim baciti izvan dohvata djece.
Uncommon side effects are: - headache, a feeling of “spinning” even when you are standing still (vertigo) - decreased appetite, weight loss - flushing (or redness) - feeling sick (nausea), retching, dry mouth - pain in your joints - swelling due to water retention (oedema) - changes in liver function tests (if you are having blood tests, tell the doctor or nurse that you have been given SANCUSO).
Manje česte nuspojave su: - glavobolja, osjećaj da Vam se "vrti" i kada stojite mirno (vrtoglavica) - smanjeni apetit, gubitak tjelesne težine - navale crvenila (ili crvenilo) - mučnina, dizanje želuca, suha usta - bol u zglobovima - oticanje zbog zadržavanja vode (oteklina) - promjene u testovima jetrene funkcije (pri obavljanju krvnih pretraga obavijestite liječnika ili medicinsku sestru da ste dobili SANCUSO).
Population PK modelling has confirmed the absence of a gender effect on the pharmacokinetics of SANCUSO.
Modeliranje populacijske farmakokinetike potvrdilo je odsutnost utjecaja spola na farmakokinetiku lijeka SANCUSO.
If your arms are not suitable areas to apply the transdermal patch your doctor may ask you to put it on your abdomen.
Ako nadlaktice nisu prikladne za primjenu transdermalnog flastera, liječnik Vam može predložiti da ga stavite na kožu trbuha.
The newly applied transdermal patch should be removed in line with the timing recommended above.
Novo nalijepljeni transdermalni flaster potrebno je ukloniti u gore preporučenom roku.
- The other ingredients are: - Transdermal patch adhesive: acrylate-vinylacetate copolymer - Backing layer: polyester - Rigid plastic film: siliconised polyester
- Drugi sastojci su: - Ljepilo transdermalnog flastera: akrilat-vinilacetat kopolimer - Vanjski potporni sloj: poliester - Čvrsta plastična podloga: silikonizirani poliester
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).
Za serotonergičke lijekove (npr. SSRI i SNRI) prijavljeni su slučajevi serotoninskog sindroma nakon istovremene primjene 5-HT3 antagonista i drugih serotonergičkih lijekova (uključujući SSRI i SNRI).
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 flaster s granizetronom primijenjen je 24 do 48 sati prije prve doze kemoterapije i ostavljen je na mjestu 7 dana.
- SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
escitalopram, - SNRI (inhibitori ponovne pohrane serotonina i noradrenalina), koji se koriste za liječenje depresije i/ili tjeskobe, uključujući venlafaksin, duloksetin.
In vitro studies have shown that ketoconazole may inhibit the metabolism of granisetron via the cytochrome P450 3A isoenzyme family.
In vitro ispitivanja pokazala su da ketokonazol može inhibirati metabolizam granizetrona putem izoenzimske skupine citokroma P450 3A.
Adverse reactions from clinical studies and spontaneous reports with SANCUSO are listed in the table below.
Tablični popis nuspojava Nuspojave iz kliničkih ispitivanja i spontanih izvješća lijeka SANCUSO navedene su u donjoj tablici.
Following routine haematological monitoring, the transdermal patch should only be applied to patients whose chemotherapy treatment is unlikely to be delayed in order to reduce the possibility of unnecessary exposure to granisetron.
Uzimajući u obzir rezultate rutinskih hematoloških ispitivanja, transdermalni flaster primjenjuje se samo u bolesnika u kojih se ne očekuje odgađanje kemoterapije, čime se smanjuje mogućnost nepotrebne izloženosti granizetronu.
Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after ‘EXP'.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i vrećici iza oznake 'Rok valjanosti'.
In human subjects, hepatic enzyme induction by phenobarbital has led to an increase in total plasma clearance (approximately 25%) following intravenous administration of granisetron.
U ljudskih ispitanika, indukcija jetrenih enzima fenobarbitalom nakon intravenske primjene granizetrona dovela je do porasta ukupnog klirensa iz plazme (za otprilike 25%).
Remove the second half of the rigid plastic film and press the whole transdermal patch firmly in place with your fingers and smooth down.
Uklonite drugu polovicu čvrste plastične podloge i čvrsto pritisnite cijeli transdermalni flaster na odabrano mjesto prstima te ga zagladite.
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 flaster SANCUSO je indiciran u odraslih osoba za prevenciju mučnine i povraćanja povezanih s primjenom umjereno ili izrazito emetogene kemoterapije, s predviđenim trajanjem od 3 do 5 uzastopnih dana, u slučaju kada je peroralna primjena antiemetika otežana zbog problema s gutanjem (vidjeti dio 5.1).
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.
Dok je primjena grijaćeg jastuka bila povezana s manjim i reverzibilnim porastom otpuštanja lijeka iz transdermalnog flastera za vrijeme grijanja, nije zapažen ukupni porast izloženosti granizetronu u usporedbi s kontrolnom skupinom.
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%.
U farmakokinetičkom ispitivanju na zdravim dobrovoljcima, koji su primali lijek SANCUSO tijekom 7 dana, aritmetička sredina ukupnog izlaganja (AUC0-beskonačnost) iznosila je 416 ng h/ml (raspon 551192 ng h/ml), s individualnom varijabilnosti od 89%.
SANCUSO is a thin, clear, rectangular-shaped transdermal patch with rounded corners, stuck onto a rigid plastic film.
SANCUSO je tanak, proziran, pravokutan transdermalni flaster sa zaobljenim uglovima, zalijepljen na čvrstu plastičnu podlogu.
No significant effect on QTc prolongation was observed for SANCUSO.
Nije uočen značajan učinak na produženje QTc intervala pri primjeni lijeka SANCUSO.
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.
Kada je potencijalna fotogenotoksičnost ispitana in vitro na staničnoj liniji jajnika kineskog hrčka, granizetron je povećao postotak stanica s oštećenjem kromosoma nakon fotoiradijacije.
Apply a single transdermal patch 24 to 48 hours before chemotherapy, as appropriate.
Primijenite jedan transdermalni flaster 24 do 48 sati prije kemoterapije, prema potrebi.
Take the transdermal patch out of the sachet.
Izvadite transdermalni flaster iz vrećice.
Tell your doctor immediately if you develop constipation or if your stomach becomes painful or swollen.
Odmah obavijestite svog liječnika ako dobijete zatvor ili primijetite bol ili oticanje trbuha.
Put the transdermal patch on a clean, dry, healthy area of skin on the outside part of your upper arm.
Stavite transdermalni flaster na čisto, suho, zdravo područje kože na vanjskoj strani nadlaktice.
In clinical trials with SANCUSO, application site reactions were reported which were generally mild in intensity and did not lead to discontinuation of use.
U kliničkim ispitivanjima s lijekom SANCUSO, reakcije na mjestu primjene bile su općenito blage i zbog njih nije bilo potrebno prekinuti primjenu.
CC was defined as no vomiting and/or retching, no more than mild nausea and no rescue medicine from the first administration until 24 hours after the start of the last day's administration of multi-day chemotherapy.
Potpuna kontrola definirana je kao nepostojanje povraćanja i/ili nagona na povraćanje, blaga mučnina i izostanak potrebe za simptomatskim liječenjem u razdoblju od prve primjene do 24 sata nakon zadnjeg dana primjene višednevne kemoterapije.
Remove a sachet from the box and tear it open using the slit provided.
Izvadite vrećicu iz kutije i otvorite je po postojećem rezu.
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.
Zbog postupnog porasta koncentracije granizetrona u plazmi nakon primjene transdermalnog flastera, početne koncentracije granizetrona u plazmi na početku kemoterapijskog liječenja mogu biti niže nego pri primjeni peroralnog granizetrona u dozi od 2 mg i stoga može kasnije doći do početka djelovanja.
In agreement with these data, no clinically relevant interactions have been reported in clinical studies with SANCUSO.
U skladu s navedenim podacima, nisu zabilježene klinički značajne interakcije u kliničkim ispitivanjima s lijekom SANCUSO.
If you forget to use SANCUSO
Ako ste zaboravili primijeniti SANCUSO
Release liner Siliconised polyester
Zaštitni sloj silikonizirani poliester
An assessment of transdermal patch adhesion in 621 patients receiving either active or placebo transdermal patches showed that less than 1% of transdermal patches became detached over the course of the 7 day period of transdermal patch application.
Procjena prianjanja transdermalnog flastera u 621 bolesnika koji su primali transdermalne flastere s djelatnom tvari ili placebom, pokazala je da se pri primjeni u trajanju od 7 dana odlijepilo manje od 1% transdermalnih flastera.
In patients with renal failure or hepatic impairment, the pharmacokinetics of granisetron were determined following a single 40 µg/kg intravenous dose of granisetron hydrochloride.
U bolesnika sa zatajenjem bubrega ili oštećenjem funkcije jetre, farmakokinetika granizetrona procjenjivana je nakon jedne intravenske doze od 40 g/kg granizetronklorida.
In clinical studies conducted with SANCUSO, clearance in cancer patients was shown to be approximately half that of healthy subjects.
U kliničkim ispitivanjima provedenima s lijekom SANCUSO, klirens u bolesnika koji boluju od raka bio je otprilike dvaput manji nego u zdravih ispitanika.
No clinically relevant interactions between SANCUSO and emetogenic cancer chemotherapies have been seen.
Nisu uočene klinički značajne interakcije između lijeka SANCUSO i emetogenih kemoterapijskih lijekova za liječenje raka.
The transdermal patch should be removed a minimum of 24 hours after completion of chemotherapy.
Transdermalni flaster potrebno je ukloniti najmanje 24 sata nakon završetka kemoterapije.
SANCUSO has no or negligible effect on your ability to drive or use any machines.
SANCUSO ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
The effects of gender on the pharmacokinetics of SANCUSO have not been specifically studied.
Utjecaj spola na farmakokinetiku lijeka SANCUSO nije posebno ispitivan.
The sticky side of the transdermal patch is covered by a two-piece rigid plastic film.
Ljepljiva strana transdermalnog flastera pokrivena je čvrstom, dvodijelnom, plastičnom podlogom.
When to apply and remove the transdermal patch
Kada primijeniti i ukloniti transdermalni flaster
- Hypersensitivity reactions, e.g. anaphylaxis, urticaria - Insomnia - Headache - Extrapyramidal reactions - Somnolence - Dizziness - QT prolongation - Constipation - Diarrhoea - Elevated hepatic transaminases - Rash - Asthenia
- Reakcije preosjetljivosti, npr. anafilaksija, urtikarija - Nesanica - Glavobolja - Ekstrapiramidne reakcije - Somnolencija - Omaglica
No correlation between creatinine clearance and total clearance was observed in cancer patients, indicating no influence of renal impairment on the pharmacokinetics of granisetron.
Nisu opažene korelacije između klirensa kreatinina i ukupnog klirensa u bolesnika koji boluju od raka, što ukazuje na činjenicu da oštećenje funkcije bubrega ne utječe na farmakokinetiku granizetrona.
The transdermal patch may be applied up to a maximum of 2 days (48 hours) before chemotherapy.
Transdermalni flaster možete primijeniti najviše 2 dana (48 sati) prije kemoterapije.
If it is not possible to apply the transdermal patch to the arm, it can be applied to the abdomen.
Ako nije moguće primijeniti transdermalni flaster na ruku, može se zalijepiti na trbuh.
In patients with hepatic impairment due to neoplastic liver involvement, total plasma clearance was approximately halved compared to patients without hepatic impairment.
U bolesnika s oštećenjem funkcije jetre zbog neoplastičnih promjena na jetri, ukupni klirens iz plazme bio je približno dvaput manji u usporedbi s bolesnicima bez oštećenja funkcije jetre.
If you stop using SANCUSO
Ako prestanete primjenjivati SANCUSO
No consistent gender effects on pharmacokinetics were observed in clinical studies with SANCUSO, with a large inter-individual variability reported in both sexes.
U kliničkim ispitivanjima s lijekom SANCUSO nisu uočeni nikakvi dosljedni učinci na farmakokinetiku, a u oba spola prijavljena je velika individualna varijabilnost.
Metabolism and nutrition disorders Decreased appetite
Poremećaji metabolizma i prehrane
Thin, translucent, matrix-type, rectangular-shaped transdermal patch with rounded corners.
Tanki, prozirni transdermalni flaster matriksnog tipa, pravokutnog oblika i zaobljenih uglova.
It is important to use this medicinal product as instructed by your doctor to prevent you feeling sick or being sick following your chemotherapy.
Važno je da lijek koristite onako kako Vas je uputio liječnik kako Vam nakon kemoterapije ne bi bilo slabo i kako ne biste povraćali.
No differences in the metabolic profiles of granisetron were observed between the oral and transdermal uses.
Biotransformacija Nisu opažene razlike u metaboličkim profilima granizetrona pri peroralnoj i transdermalnoj primjeni.
The transdermal patch can be worn for up to 7 days depending on the duration of your chemotherapy treatment.
Transdermalni flaster može se nositi do 7 dana ovisno o trajanju liječenja kemoterapijom.
Try to avoid wearing the transdermal patch in water for long periods of time.
Izbjegavajte dulje držanje flastera u vodi.
The study was designed to show non-inferiority of SANCUSO to oral granisetron.
Ispitivanje je provedeno radi dokazivanja neinferiornosti lijeka SANCUSO u usporedbi s peroralnim granizetronom.
After removing the transdermal patch you may find some sticky material is left on your skin.
Nakon uklanjanja transdermalnog flastera na koži može ostati ljepljivog materijala.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
However, no clinically relevant effects on ECG have been observed in clinical studies with SANCUSO, including a through QT study in 240 healthy subjects (section 5.1).
Međutim, u kliničkim ispitivanjima s lijekom SANCUSO, uključujući temeljito ispitivanje QT intervala na 240 zdravih ispitanika, nisu zapaženi klinički značajni učinci na EKG (dio 5.1).
The transdermal patch should be applied to clean, dry, intact healthy skin on the outer part of the upper arm.
Transdermalni flaster treba zalijepiti na čistu, suhu, neoštećenu zdravu kožu na vanjskoj strani nadlaktice.
Backing layer Polyester
Vanjski potporni sloj poliester
After removing the transdermal patch
Nakon uklanjanja transdermalnog flastera
Each carton contains one transdermal patch.
Svaka kutija sadrži jedan transdermalni flaster.
Paediatric population No studies have been performed to investigate the pharmacokinetics of SANCUSO in paediatrics.
Pedijatrijska populacija Nisu provedena ispitivanja farmakokinetike lijeka SANCUSO u pedijatrijskih bolesnika.
The signs may include red, raised itchy bumps
Simptomi mogu uključivati crvene, izdignute izbočine koje svrbe.
Application site irritation Application site reactions (application site pain, application site pruritus, application site erythema, application site rash, application site irritation) *
Reakcije na mjestu primjene (bol na mjestu primjene, svrbež na mjestu primjene, eritem na mjestu primjene, osip na mjestu primjene i iritacija na mjestu primjene) *
How to use SANCUSO
Kako primjenjivati SANCUSO
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.
Na zdravim ispitanicima ispitana je istovremena primjena jednog intravenskog bolusa od 0,01 mg/kg granizetrona (najviše 1 mg) i transdermalnog flastera SANCUSO.
Patients must be advised to cover the transdermal patch application site, e.g. with clothing, if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal.
Potrebno je savjetovati bolesnike da pokriju mjesto primjene transdermalnog flastera, npr. odjećom, cijelo vrijeme tijekom nošenja flastera i još 10 dana nakon njegovog uklanjanja ako postoji opasnost od izlaganja sunčevoj svjetlosti.
Each carton contains 1 transdermal patch.
Svaka kutija sadrži 1 transdermalni flaster.
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.
Ako se flaster ne može ponovno zalijepiti ili je oštećen, potrebno je na isto mjesto zalijepiti novi transdermalni flaster.
No clinical studies have been performed specifically to investigate the pharmacokinetics of SANCUSO in patients with renal or hepatic impairment.
Nisu provedena posebna klinička ispitivanja farmakokinetike lijeka SANCUSO u bolesnika s oštećenjem funkcije bubrega ili jetre.
The transdermal patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen.
Transdermalni flaster može se nositi do 7 dana ovisno o trajanju kemoterapijskog protokola.
As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration.
Granizetron može smanjiti motilitet donjeg dijela crijeva pa je zbog toga nakon primjene potrebno pratiti bolesnike sa znakovima subakutne opstrukcije crijeva.