natgillin/translations-raw huggingface dataset:
Granisetron crosses intact skin into the systemic circulation by a passive diffusion process.
Granizetron prolazi kroz neoštećenu kožu u sistemsku cirkulaciju procesom pasivne difuzije.
SANCUSO can affect the way some medicines work.
SANCUSO može utjecati na djelovanje nekih lijekova.
Alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased
Porast alanin-aminotransferaze, porast aspartat- aminotransferaze, porast gama- glutamiltransferaze
Continue to keep the application site covered for a further 10 days after removing the transdermal patch.
Mjesto primjene držite pokrivenim još 10 dana nakon uklanjanja transdermalnog flastera.
This redness should go away over time.
Crvenilo će nestati s vremenom.
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).
Područje koje odaberete ne smije biti masno ili nedavno obrijano ili s bilo kakvim kožnim oštećenjima poput ozljeda (rezova ili ogrebotina) ili nadraženosti (crvenilo ili osip).
External heat
Vanjski izvori topline
Carcinogenicity studies showed no special hazard for humans when used at the recommended dose.
Ispitivanja kancerogenosti nisu pokazala poseban rizik za ljude pri primjeni lijeka u preporučenoj dozi.
Within the system organ class, the adverse reactions are listed by frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Unutar klasifikacije organskih sustava, nuspojave su navedene prema učestalosti na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000);
Press firmly making sure there is good contact with the skin, especially around the edges.
Čvrsto ga pritisnite osiguravajući dobro prianjanje uz kožu, naročito oko rubova.
Granisetron is distributed with a mean volume of distribution of approximately 3 l/kg.
Granizetron se distribuira s aritmetičkom sredinom volumena distribucije od otprilike 3 l/kg.
This variability is similar to the known high variability in granisetron pharmacokinetics after oral or intravenous administration.
Ta varijabilnost je slična poznatoj visokoj varijabilnosti u farmakokinetici granizetrona nakon peroralne ili intravenske primjene.
- However, the transdermal patch may become partially unstuck.
Međutim transdermalni flaster može se djelomično odlijepiti.
Granisetron has been shown to block both sodium and potassium channels, which could affect cardiac depolorisation and repolarisation and therefore PR, QRS, and QT intervals.
Pokazalo se da granizetron blokira natrijeve i kalijeve kanale koji bi mogli utjecati na depolarizaciju i repolarizaciju srca i stoga na intervale PR, QRS i QT.
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).
Iako klinički značaj tog otkrića nije potpuno jasan, bolesnike je potrebno savjetovati da pokriju mjesto primjene transdermalnog flastera ako postoji opasnost od izlaganja sunčevoj svjetlosti tijekom razdoblja nošenja i 10 dana nakon uklanjanja (vidjeti dio 4.4).
However, when administered in higher doses and over a prolonged period of time, the risk of carcinogenicity cannot be ruled out but with the short application period recommended for the transdermal delivery system, a carcinogenic risk for humans is not expected.
Međutim pri primjeni lijeka u većim dozama i tijekom duljeg razdoblja, ne može se isključiti rizik od kancerogenosti, ali kod kratkog razdoblja primjene koje se preporučuje za transdermalni sustav primjene lijeka, ne očekuje se rizik od kancerogenosti za ljude.
Pharbil Waltrop GmbH (a subsidiary of NextPharma) Im Wirrigen 25
Pharbil Waltrop GmbH (podružnica tvrtke NextPharma) Im Wirrigen 25
Use of concomitant corticosteroids
Istovremena primjena kortikosteroida
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).
U ispitivanjima na zdravim osobama nisu utvrđene interakcije između granizetrona i benzodiazepina (lorazepam), neuroleptika (haloperidol) ili antiulkusnih lijekova (cimetidin).
Wash your hands after applying the transdermal patch.
Operite ruke nakon primjene transdermalnog flastera.
Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5HT3 receptors).
Granizetron je potentni antiemetik i vrlo selektivni antagonist 5-hidroksitriptamina (5HT3 receptora).
Radioligand binding studies have demonstrated that granisetron has negligible affinity for other receptor types, including 5HT1, 5HT2, 5HT4 and dopamine D2 binding sites.
Ispitivanja vezivanja redioaktivno označenih liganda pokazala su da granizetron ima zanemariv afinitet za druge vrste receptora, uključujući za 5HT1, 5HT2, 5HT4 i vezivna mjesta D2 za dopamin.
It is not known how activities such as swimming, strenuous exercise or using a sauna or whirlpool, may affect this medicine.
Nije poznato kako aktivnosti poput plivanja, intenzivnog vježbanja ili korištenja saune ili masažnog bazena mogu utjecati na ovaj lijek.
Granisetron was not phototoxic when tested in vitro in a mouse fibroblast cell line.
Granizetron nije bio fototoksičan kada je ispitan in vitro na staničnoj liniji mišjih fibroblasta.
The recommended dose is one single transdermal patch.
Preporučena doza je jedan transdermalni flaster.
It is unknown whether granisetron or its metabolites are excreted in human milk.
Nije poznato izlučuje li se granizetron ili njegovi metaboliti u majčino mlijeko.
The known pharmacokinetic profile of the transdermal patch over the period of wear (7 days) was not affected.
To nije utjecalo na poznati farmakokinetički profil transdermalnog flastera za vrijeme nošenja (7 dana).
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.
Važno je učiniti sljedeće: - dok nosite transdermalni flaster, držite ga pokrivenim odjećom ako ćete se izlagati sunčevoj svjetlosti ili svjetlu UV-lampi, uključujući solarij, - kožu na kojoj je bio zalijepljen ovaj lijek držite pokrivenu još 10 dana nakon uklanjanja transdermalnog flastera kako biste je zaštitili od izravne sunčeve svjetlosti.
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.
Budući da granizetron metaboliziraju enzimi citokroma P450 u jetri (CYP1A1 i CYP3A4) koji metaboliziraju djelatne tvari, induktori ili inhibitori tih enzima mogu promijeniti klirens i, posljedično, poluvijek granizetrona.
Do not re-use the transdermal patch after removal, see below for instructions on transdermal patch removal and disposal (see section 5).
Nakon što uklonite transdermalni flaster nemojte ga ponovno koristiti, pogledajte u nastavku upute kako ga ukloniti i zbrinuti (vidjeti dio 5).
Do not use this medicine if you are pregnant unless your doctor has specifically recommended it. Stop breast-feeding while wearing the patch.
Nemojte koristiti ovaj lijek ako ste trudni, osim ako Vam to liječnik izričito preporuči.
This leaflet was last revised in July 2018
Ova uputa je zadnji puta revidirana u
Also some other medicines can affect the way SANCUSO works.
Isto tako drugi lijekovi mogu utjecati na djelovanje lijeka SANCUSO.
There are no data on the effect of granisetron on human fertility.
Nema podataka o učinku granizetrona na plodnost u ljudi.
Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Preporučuje se odgovarajuće praćenje bolesnika da bi se uočili simptomi nalik serotoninskom sindromu.
The mean plasma half-life in healthy subjects is 4-6 hours and in patients is 9-12 hours.
Aritmetička sredina poluvijeka u plazmi u zdravih ispitanika iznosila je 4-6 sati, a u bolesnika 9-12 sati.
The safety profile of SANCUSO is derived from controlled clinical trials and from post-marketing experience.
Sigurnosni profil lijeka SANCUSO rezultat je kontroliranih kliničkih ispitivanja i iskustva nakon stavljanja lijeka u promet.
Each transdermal patch is packed in a sachet and should be applied directly after the sachet has been opened.
Svaki transdermalni flaster zapakiran je u vrećici i potrebno ga je zalijepiti neposredno nakon otvaranja vrećice.
The Multinational Association of Supportive Care in Cancer (MASCC) guidelines recommend the administration of dexamethasone with 5HT3 antagonist prior to chemotherapy.
Smjernice Multinacionalnog udruženja za potporno liječenje raka (Multinational Association of Supportive Care in Cancer; MASCC) preporučuju primjenu deksametazona s antagonistom 5HT3 receptora prije kemoterapije.
Other ingredients: acrylate-vinylacetate copolymer, polyester, siliconised polyester.
Ostali sastojci: akrilat-vinilacetat kopolimer, poliester, silikonizirani poliester.
Bend the transdermal patch in the middle and remove one half of the rigid plastic film.
Savijte transdermalni flaster u sredini i uklonite jednu polovicu čvrste plastične podloge.
Granisetron is cleared primarily by hepatic metabolism.
Granizetron se uklanja prvenstveno metabolizmom u jetri.
This potentially may have clinical significance in patients with pre-existing arrhythmias or cardiac conduction disorders or patients who are being treated with antiarrhythmics or beta-blockers.
To bi moglo biti klinički značajno u bolesnika s već postojećim aritmijama ili poremećajima provodnog sustava srca ili u bolesnika koji uzimaju antiaritmike ili beta blokatore.
After intravenous dosing, the mean plasma clearance ranged from 33.4 to 75.7 l/h in healthy subjects and from 14.7 to 33.6 l/h in patients with wide inter-subject variability.
Nakon intravenske primjene, aritmetička sredina klirensa iz plazme bila je u rasponu od 33,4 do 75,7 l/h u zdravih ispitanika i od 14,7 do 33,6 l/h u bolesnika sa širokom individualnom varijabilnosti.
Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists, ATC code: A04AA02.
Farmakoterapijska skupina: Antiemetici i sredstva protiv mučnine, antagonisti serotonina (5HT3), ATK oznaka: A04AA02.
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.
Lijek u transdermalnom flasteru postupno prolazi kroz Vašu kožu u tijelo i, stoga se flaster primjenjuje 1 do 2 dana (24 do 48 sati) prije početka liječenja kemoterapijom.
Hypersensitivity to the active substance, to other 5-HT3 receptor antagonists or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatnu tvar, na druge antagoniste 5-HT3 receptora ili neku od pomoćnih tvari navedenih u dijelu 6.1.
The active substance in SANCUSO is granisetron, which belongs to a group of medicines called antiemetics and antinauseants.
Djelatna tvar u lijeku SANCUSO je granizetron, koji pripada skupini lijekova koji se nazivaju antiemetici i sredstva protiv mučnine.
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.
Istovremena intravenska primjena antagonista 5-HT3 receptora i peroralnog paracetamola u ljudskih ispitanika rezultirala je blokiranjem analgetskog učinka putem farmakodinamičkog mehanizma.
If the transdermal patch is lost or becomes damaged go back to your doctor.
Ako transdermalni flaster otpadne ili se ošteti obratite se svom liječniku.
Any increase in corticosteroid use during the study was reported as rescue treatment.
Bilo koje povećanje doze kortikosteroida tijekom ispitivanja karakterizirano je kao simptomatsko liječenje.
Be careful not to stick the transdermal patch to itself and avoid touching the sticky side of the transdermal patch.
Pazite da se transdermalni flaster ne zalijepi sam sa sobom i da ne dotičete ljepljivi dio transdermalnog flastera.
In the event of a transdermal patch becoming completely or partially detached, the original transdermal patch should be reattached in the same position using medical tape (if necessary).
U slučaju potpunog ili djelomičnog odljepljivanja transdermalnog flastera, potrebno ga je zalijepiti na isto mjesto uz pomoć medicinske ljepljive trake (ako je potrebno).
Things to remember when using the transdermal patch - Do not keep or store the transdermal patch outside the sealed sachet.
Što trebate imati na umu za vrijeme primjene transdermalnog flastera - Nemojte držati ili čuvati transdermalni flaster izvan zapečaćene vrećice.
In vitro studies using human liver microsomes indicate that CYP1A1 is the major enzyme responsible for the 7-hydroxylation of granisetron, whereas CYP3A4 contributes to 9'desmethylation.
In vitro ispitivanja na mikrosomima ljudske jetre pokazala su da je CYP1A1 glavni enzim odgovoran za 7hidroksilaciju granizetrona, dok CYP3A4 pridonosi 9'desmetilaciji.
The transdermal patch should not be placed on skin that is red, irritated or damaged.
Transdermalni flaster ne smije se lijepiti na crvenu, nadraženu ili oštećenu kožu.
The population randomised into the trial included 48% males and 52% females aged 16 to 86 years receiving moderately emetogenic (ME) or highly emetogenic (HE) multi-day chemotherapy.
Populacija koja je bila randomizirana u ispitivanje uključivala je 48% muškaraca i 52% žena u dobi od 16 do 86 godina koji su primali umjereno emetogenu ili izrazito emetogenu višednevnu kemoterapiju.
In clinical trials with SANCUSO, there were no treatment-related effects on heart rate or blood pressure.
U kliničkim ispitivanjima s lijekom SANCUSO, nije bilo učinaka povezanih s liječenjem na srčanu frekvenciju ili krvni tlak.
Following SANCUSO application, granisetron is absorbed slowly, with maximal concentrations reached between 24 and 48 hours.
Nakon primjene transdermalnog flastera SANCUSO, granizetron se sporo apsorbira, a maksimalne koncentracije se dosežu nakon 24 do 48 sati.
- Use only one transdermal patch at a time.
- Istovremeno se smije koristiti samo jedan transdermalni flaster.
- 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).
- Kada uklonite transdermalni flaster, pogledajte kako izgleda Vaša koža i obavijestite liječnika ako primijetite ozbiljnu kožnu reakciju (ako Vam je koža jako crvena, svrbi ili uočite mjehuriće).
Given the wide variability in pharmacokinetic parameters of granisetron and the good tolerance well above the recommended dose, dose adjustment in patients with functional hepatic impairment is not necessary.
Zbog velike varijabilnosti u farmakokinetičkim parametrima granizetrona i dobroj podnošljivosti doza znatno iznad preporučene doze, prilagođavanje doze u bolesnika s oštećenjem funkcije jetre nije potrebno.
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.
Učinak lijeka SANCUSO na QTc interval bio je posebno procjenjivan u slijepom, randomiziranom, usporednom ispitivanju QTc intervala, kontroliranom placebom i pozitivnom kontrolom (moksifloksacin), s lijekom SANCUSO u 240 odraslih muškaraca i žena.
A study in cloned human cardiac ion channels has shown that granisetron has the potential to affect cardiac repolarisation via blockade of hERG potassium channels.
Ispitivanje na kloniranim ljudskim srčanim ionskim kanalima pokazalo je da granizetron može utjecati na repolarizaciju srca blokadom kalijevih kanala hERG.
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).
U kliničkom ispitivanju nisu uočene razlike u farmakokinetici lijeka SANCUSO u plazmi u muških i ženskih ispitanika starije dobi (≥ 65 godina) u usporedbi s mlađim ispitanicima (u dobi od 18 do uključivo 45 godina).
A pivotal, randomised, double-blind, double-dummy, multinational Phase III study compared the efficacy, tolerability and safety of SANCUSO with that of 2 mg oral granisetron once daily in the prevention of nausea and vomiting in a total of 641 patients receiving multi-day chemotherapy.
U ključnom randomiziranom, dvostruko slijepom i s dvostrukim placebom multinacionalnom ispitivanju faze III, uspoređena je djelotvornost, podnošljivost i sigurnost lijeka SANCUSO i 2 mg granizetrona primijenjenog peroralno jedanput dnevno u prevenciji mučnine i povraćanja u ukupno 641 bolesnika koji su primali višednevnu kemoterapiju.
Assessment of serial ECGs in patients showed no QT prolongation and no change in ECG morphology.
Pregled uzastopnih EKG-ova u bolesnika nije pokazao produženje QT intervala niti promjenu u morfologiji EKG-a.
Showering or washing normally can be continued while wearing SANCUSO.
Bolesnik se može normalno nastaviti tuširati ili prati dok nosi SANCUSO.
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.
S obzirom na rezidualni sadržaj transdermalnog flastera nakon uklanjanja, apsorbira se otprilike 65% granizetrona, u prosječnoj dozi od 3,1 mg dnevno.
Mean Cmax was 3.9 ng/ml (range 0.7 - 9.5 ng/ml), with a between subject variability of 77%.
Aritmetička sredina Cmax iznosila je 3,9 ng/ml (raspon 0,7 - 9,5 ng/ml), s individualnom varijabilnosti od 77%.
When tested for skin sensitising potential in guinea pigs, SANCUSO showed a low potential for irritancy.
Kada je ispitan potencijal senzibilizacije kože na zamorcima, lijek SANCUSO pokazao je niski potencijal za iritaciju.
- The transdermal patch may be affected by direct sunlight or exposure to sunlamps.
Na transdermalni flaster može utjecati izravna sunčeva svjetlost ili izlaganje UV-lampama.
5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities.
Antagonisti 5-HT3 receptora, kao što je granizetron, mogu biti povezani s aritmijama ili poremećajima EKG-a.
Name and address of the manufacturer responsible for batch release PHARBIL Waltrop GmbH(a subsidiary of NextPharma) Im Wirrigen 25
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet PHARBIL Waltrop GmbH (podružnica tvrtke NextPharma) Im Wirrigen 25
Breast-feeding should be discontinued during treatment with SANCUSO.
Dojenje je potrebno prekinuti za vrijeme liječenja lijekom SANCUSO.
In vitro studies using human microsomes indicate that granisetron neither stimulates nor inhibits the cytochrome P450 enzyme system.
In vitro ispitivanja na ljudskim mikrosomima pokazuju da granizetron ne stimulira niti inhibira enzimski sustav citokroma P450.
If this is not possible, a new transdermal patch should be applied on the opposite arm.
Ako to nije moguće, potrebno je novi transdermalni flaster zalijepiti na suprotnu ruku.
While you are wearing the transdermal patch you must keep it covered, e.g. under clothing, if there is a risk of exposure to sunlight or sunlamps.
Dok nosite transdermalni flaster pazite da bude pokriven, na primjer ispod odjeće, ako postoji opasnost od izlaganja sunčevoj svjetlosti ili UV-lampama.
Wear the transdermal patch all the time during your chemotherapy.
Nosite transdermalni flaster cijelo vrijeme tijekom kemoterapije.
Patients who are being treated with moderately or highly emetogenic chemotherapy may still experience vomiting despite treatment with antiemetic therapy, including SANCUSO.
Bolesnici liječeni umjereno ili izrazito emetogenom kemoterapijom mogu povraćati unatoč primijenjenom antiemetičkom liječenju, uključujući i SANCUSO.
It is important to use this medicine during the whole length of your chemotherapy (up to 7 days) to prevent you feeling sick or being sick following your chemotherapy.
Važno je da primjenjujete lijek tijekom cijelog trajanja kemoterapije (do 7 dana) kako biste spriječili mučninu ili povraćanje uslijed kemoterapije.
If the transdermal patch starts to become unstuck, the same transdermal patch may be secured to the same area of skin.
Ako se transdermalni flaster počinje odljepljivati, isti transdermalni flaster možete pričvrstiti na isto područje kože.
In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of granisetron.
U kliničkim ispitivanjima interakcija, aprepitant nije imao klinički značajne učinke na farmakokinetiku granizetrona.
In the pivotal SANCUSO study, the concomitant use of corticosteroids, e.g. dexamethasone, was permitted provided it was part of the chemotherapy regimen.
U ključnom ispitivanju lijeka SANCUSO bila je dozvoljena istovremena primjena kortikosteroida, npr. deksametazona, ako je bio dio kemoterapijskog protokola.
There are no data on the use of granisetron in pregnant women.
Nema podataka o primjeni granizetrona u trudnica.
Furthermore, no interaction has been observed between granisetron and emetogenic cancer therapies.
Nadalje, nije uočena interakcija između granizetrona i emetogenih terapija za liječenje raka.
In the event of overdose, the transdermal patch should be removed.
U slučaju predoziranja, potrebno je ukloniti transdermalni flaster.
While holding the remaining half of the rigid plastic film, apply the transdermal patch to the skin on the outside part of your upper arm.
Dok držite preostalu polovicu čvrste plastične podloge, zalijepite transdermalni flaster na kožu na vanjskoj strani nadlatkice.
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).
SANCUSO je transdermalni (za primjenu kroz kožu) flaster koji se koristi za sprječavanje mučnine i povraćanja u odraslih osoba koje primaju kemoterapiju (lijekove za liječenje raka) koja traje 3 do 5 dana i koji imaju poteškoća u gutanju tableta (zbog, na primjer, osjetljivosti, suhoće ili upale usne šupljine ili grla).
- 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.
- Nema podataka o utjecaju aktivnosti poput intenzivnog vježbanja, korištenja saune ili masažnih bazena na transdermalni flaster; zato dok nosite transdermalni flaster izbjegavajte te aktivnosti.
If severe reactions, or a generalised skin reaction occur (e.g. allergic rash, including erythematous, macular, papular rash or pruritus), the transdermal patch must be removed.
U slučaju teških reakcija ili generalizirane kožne reakcije (npr. alergijskog osipa, uključujući eritematozni, makularni, papulozni osip ili svrbež), potrebno je ukloniti transdermalni flaster.
Oral granisetron was administered daily for the duration of the chemotherapy regimen, one hour prior to each dose of chemotherapy.
Peroralni granizetron primjenjivan je svakodnevno za vrijeme trajanja kemoterapijskog protokola, jedan sat prije svake doze kemoterapije.