natgillin/translations-raw huggingface dataset:
The tablet is a white, biconvex, round, film-coated tablet, with a diameter of 7.1 mm and a thickness of 2.7 mm, imprinted with ‘15' on one side, and ‘102' and '15 mg' on the other side, in grey ink.
Tableta je bijela, bikonveksna, okrugla filmom obložena tableta, promjera 7,1 mm i debljine 2,7 mm, s oznakom ‘15' na jednoj strani, i ‘102' i '15 mg' na drugoj, u sivoj tinti.
Median PFS (months)a [95% CI]b Hazard ratio [95% CI] P-value c
Medijan PFS (mjeseci)a [95% CI]b Omjer hazarda [95% CI] P-vrijednostc
In a dedicated study the PK of trifluridine and tipiracil hydrochloride were evaluated in cancer patients with mild or moderate hepatic impairment (National Cancer Institute [NCI] Criteria Group B and C, respectively) and in patients with normal hepatic function.
U posebnom PK ispitivanju trifluridina i tipiracilklorida ocjenjivani su onkološki bolesnici s blagim ili umjerenim oštećenjem jetrene funkcije (skupina B odnosno C prema kriterijima nacionalnog instituta za rak [engl.
Repeat-dose toxicity
Ispitivanja toksičnosti ponovljenih doza
Lower respiratory tract infection
Infekcija donjih dišnih puteva
In addition, a higher exposure of trifluridine and tipiracil was observed in patients with moderate renal impairment, compared with patients with normal renal function or patients with mild renal impairment (see section 5.2).
Nadalje, kod bolesnika s umjerenim oštećenjem bubrega je primijećena veća izloženost trifluridinu i tipiracilu u usporedbi s bolesnicima s normalnom funkcijom bubrega ili bolesnicima s blagim oštećenjem bubrega (vidjeti dio
• inflammation, swelling or bleeding in your bowel
• upala, oteklina ili krvarenje u crijevima
Whitening, breakage, and malocclusion were observed in teeth of rats treated with trifluridine/tipiracil hydrochloride, which are considered rodent specific and not relevant for human.
Kod zubiju štakora kojima je davan trifluridin/tipiracilklorid je primjećeno izbjeljivanje, lomljivost te malokluzija, no to se smatra specifičnim za glodavce te nevažnim za ljude.
Gastrectomy
Gastrektomija
• runny or bloody nose, sinus problems
• curenje ili krvarenja nosa, poteškoće sa sinusima
C-reactive protein increased
Povišen c-reaktivni protein Snižen hematokrit a.
• reduced white blood cells called leucocytes - can increase your risk for infection
• smanjenje broja bijelih krvnih stanica koje se nazivaju leukociti - može povećati rizik za infekciju
• bone pain, muscle pain, muscle weakness or spasms, pain in tendons, nerves or ligaments
• bol u kostima, bol u mišićima, slabost mišića ili grčevi, bol u tetivama, živcima ili ligamentima
Overall Survival Number of deaths, N (%) Median OS (months)a [95% CI]b Hazard ratio [95% CI] P-valuec
Ukupno preživljenje (OS) Broj smrtnih slučajeva, N (%) Medijan OS (mjeseci)a [95% CI]b Omjer hazarda [95% CI] P-vrijednostc
• painful tongue, polyps inside your mouth, mouth ulcers, retching
• bolnost jezika, polipi u ustima, vrijed u ustima, dizanje želudca
What Lonsurf contains Lonsurf 15 mg/6.14 mg tablet
Što Lonsurf sadrži Lonsurf 15 mg/6,14 mg tablete
Neutrophils
Broj neutrofila
• more noticeable heart-beat, chest pain
• jači osjećaj srčanih otkucaja, bolovi u prsima
- Printing ink: shellac, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine aluminium lake (E132), carnauba wax and talc.
- Tinta za označavanje: šelak, željezov oksid crveni (E172), željezov oksid žuti (E172), titanijev dioksid (E171), boja indigo carmin aluminium lake (E132), karnauba vosak i talk.
The median OS was 5.7 months (95% CI: 4.8, 6.2) for the Lonsurf group versus 3.6 months (95% CI: 3.1, 4.1) for the placebo group; with 1-year survival rates of 21.2% and 13.0%, respectively.
(95% CI: 4,8; 6,2) u usporedbi sa 3,6 mjeseci kod placeba (95% CI: 3,1; 4,1); sa stopom jednogodišnjeg preživljenja od 21,2% u usporedbi sa 13,0% kod placeba.
The signs include unusual bruising or bleeding (see section 2).
Znaci uključuju neobjašnjive modrice ili krvarenja (pogledajte dio
- Film coating: hypromellose, macrogol (8000), titanium dioxide (E171), iron oxide red (E172) and magnesium stearate.
- Film ovojnica: hipromeloza, makrogol (8000), titanijev dioksid (E171), željezov oksid crveni (E172) i magnezijev stearat.
QUALITATIVE AND QUANTITATIVE COMPOSITION Lonsurf 15 mg/6.14 mg film-coated tablets
KVALITATIVNI I KVANTITATIVNI SASTAV Lonsurf 15 mg/6,14 mg filmom obložene tablete
Each tablet contains 20 mg trifluridine and 8.19 mg tipiracil.
Svaka tableta sadrži 20 mg trifluridina i 8,19 mg tipiracila
No correlation was seen for trifluridine nor tipiracil hydrochloride between PK parameters and AST or/and total blood bilirubin.
Nije dokazana povezanost između PK parametara i AST i/ili ukupnog bilirubina u krvi niti za trifluridin niti za tipiracilklorid.
In total, 507 patients were randomised 2:1 to receive Lonsurf (N = 337) plus best supportive care (BSC) or placebo (N = 170) plus BSC. Lonsurf dosing was based on BSA with a starting dose of 35 mg/m2/dose.
Ukupno je 507 bolesnika bilo randomizirano u omjeru 2:1 ili u skupinu koja je primala Lonsurf (N=337) uz najbolju potpornu njegu (eng. best supportive care, BSC) ili u skupinu koja je primala placebo (N = 170) uz BSC.
EU/1/16/1096/006 60 film-coated tablets
EU/1/16/1096/006 60 filmom obloženih tableta
The tablet is a pale red, biconvex, round, film-coated tablet, with a diameter of 7.6 mm and a thickness of 3.2 mm, imprinted with ‘20' on one side, and ‘102' and ‘20 mg' on the other side, in grey ink.
Tableta je blijedo crvena, bikonveksna, okrugla filmom obložena tableta, promjera 7,6 mm i debljine 3,2 mm, s oznakom ‘20' na jednoj strani, i ‘102' i '20 mg' na drugoj, u sivoj tinti.
Lonsurf is for oral use.
Lonsurf se primjenjuje peroralno.
EU/1/16/1096/005 40 film-coated tablets
EU/1/16/1096/005 40 filmom obloženih tableta
No adjustment of the starting dose is recommended in patients with mild or moderate renal impairment (see sections 4.4 and 5.2).
Nije potrebno prilagoditi početnu dozu u bolesnika s blagim i umjerenim oštećenjem bubrega (vidjeti dijelove 4.4 i 5.2).
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1096/004 20 film-coated tablets
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1096/004 20 filmom obloženih tableta
Servier Polska Sp. z o.o.
Servier Italia S.p.A.
Neurotoxicity Dysaesthesia Hyperaesthesia Hypoaesthesia Syncope
Neurotoksičnost Disestezija Hiperestezija Hipoestezija
Gastrooesophageal reflux disease Proctalgia
Dispepsija Gastroezofagealna refluksna bolest
• inflammation and infection in your gut
• upala i infekcija u crijevima
Hyperbilirubinaemia Hepatotoxicity Biliary dilatation
Hiperbilirubinemija Hepatotoksičnost
The clinical efficacy and safety of Lonsurf were evaluated in an international, randomised, doubleblind, placebo-controlled Phase III study (TAGS) in patients with previously treated metastatic gastric cancer (including adenocarcinoma of the gastroesophageal junction), who had been previously treated with at least two prior systemic treatment regimens for advanced disease, including fluoropyrimidine-, platinum-, and either taxane- or irinotecan-based chemotherapy, plus if appropriate human epidermal growth factor receptor 2 (HER2) -targeted therapy.
Klinička djelotvornost i sigurnost Lonsurfa ispitivane su u internacionalnom, randomiziranom, dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju faze III (TAGS) u bolesnika s prethodno liječenim metastatskim karcinomom želuca (uključujući adenokarcinom gastroezofagealnog spoja) koji su prethodno bili liječeni s najmanje dva režima sistemskog liječenja uznapredovale
Metastatic gastric cancer
Metastatski karcinom želuca
Lonsurf plus BSC (N=534)
(N=534)
Administration is not recommended in patients with baseline moderate or severe hepatic impairment (National Cancer Institute [NCI] Criteria Group C and D defined by total bilirubin > 1.5 x ULN) as, a higher incidence of Grade 3 or 4 hyperbilirubinaemia is observed in patients with baseline moderate hepatic impairment, although this is based on very limited data (see sections 4.4 and 5.2).
National Cancer Institute, NCI] definirano ukupnim bilirubinom > 1,5 x gornja granica normale) budući da je zabilježena povećana incidencija hiperbilirubinemije 3. ili 4. stupnja u bolesnika s umjerenim oštećenjem jetre na početku liječenja, iako se ovo temelji na vrlo ograničenim podacima (vidjeti dijelove 4.4 i 5.2).
• reduced number of white blood cells called lymphocytes - can increase your risk for infection
• smanjeni broj bijelih krvnih stanica koje se nazivaju limfociti - može povećati rizik za infekcije
Hazard ratio for progression or death, 0.48 (95% CI, 0.41-0.57) P<0.0001 by log-rank test
Omjer hazarda za progresiju bolesti ili smrt, 0,48 (95% CI, 0,41-0,57) P<0,0001; log-rank test
• problems passing water (urine retention), loss of bladder control (incontinence)
• promjene u nalazu testa mokraće, krv u mokraći • problemi s mokrenjem (zadržavanje mokraće), gubitak kontroliranja mokraćnog mjehura
Approximately half (55.4%) of patients received prior irinotecan, 33.3% received prior ramucirumab, and 16.6% received prior HER2-targeted therapy.
Približno polovica (55,4%) bolesnika primila je ranije irinotekan, 33,3%
Placebo plus BSC (N=266)
(N=266)
The median time to PS ≥ 2 for the Lonsurf group and placebo group was 5.7 months and 4.0 months, respectively, with a hazard ratio of 0.66 (95% CI: [0.56, 0.78]), p < 0.0001.
Medijan vremena do PS ≥ 2 u skupini liječenoj Lonsurfom bio je 5,7 mjeseci, a u placebo skupini 4,0 mjeseci s omjerom hazarda 0,66 (95% CI [0,56; 0,78]), p < 0,0001.
PFS was significantly improved in patients receiving Lonsurf plus BSC compared to placebo plus BSC (HR of 0.57; 95% CI [0.47 to 0.70]; p < 0.0001 (see Table 7, Figure 3 and Figure 4).
Preživljenje bez progresije (PFS) je značajno bolje u bolesnika koji su primali Lonsurf uz BSC u usporedbi sa skupinom koja je primala placebo uz BSC (omjer hazarda 0,57; 95% CI [0,47 do 0,70]; p < 0,0001 (vidjeti Tablicu 7, Sliku 3 i Sliku 4).
Lonsurf 20 mg/8.19 mg tablet
Lonsurf 20 mg/8,19 mg tablete
An OS analysis of the study, carried out as planned at 72% (N = 574) of events, demonstrated a clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.68; 95% confidence interval [CI] [0.58 to 0.81]; p < 0.0001) and a median OS of 7.1 months vs 5.3 months, respectively; with 1-year survival rates of 26.6% and 17.6%, respectively.
Analiza ukupnog preživljenja (OS), provedena kako je planirana, za 72% (N=574) događaja, pokazala je klinički i statistički značajnu korist u smislu preživljenja kod primjene Lonsurfa uz BSC u usporedbi sa primjenom placeba uz BSC (omjer hazarda 0,68%, 95% interval pouzdanosti [CI] [0,58 do 0,81]; p < 0,0001) te medijan OS iznosi 7,1 mjesec u usporedbi sa 5,3 mjeseca kod placeba; sa stopom jednogodišnjeg preživljenja od 26,6% u usporedbi sa 17,6% kod placeba.
PFS was significantly improved in patients receiving Lonsurf plus BSC (hazard ratio: 0.48; 95% CI [0.41 to 0.57]; p < 0.0001 (see Table 6, Figure 1 and Figure 2).
Preživljenje bez progresije (PFS) je značajno bolje u bolesnika koji su primali Lonsurf uz BSC (omjer hazarda 0,48 %; 95% CI [0,41 do 0,57]; p < 0,0001 (vidjeti Tablicu 6, Sliku 1 i Sliku 2).
Pulmonary embolismb
Plućna embolija
Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
Lonsurf 15 mg/6,14 mg filmom obložene tablete Lonsurf 20 mg/8,19 mg filmom obložene tablete trifluridin/tipiracil
An updated OS analysis, carried out at 89% (N = 712) of events, confirmed the clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.69; 95% CI [0.59 to 0.81]; p < 0.0001) and a median OS of 7.2 months vs 5.2 months; with 1-year survival rates of 27.1% and 16.6%, respectively.
Ažurirana analiza OS u ispitivanju provedena je za 89% (N=712) događaja, te je potvrdila kliničku i statistički značajnu korist u smislu preživljenja kod primjene Lonsurfa uz BSC u usporedbi sa primjenom placeba uz BSC (omjer hazarda 0,69%, 95% [CI] [0,59 do 0,81]; p < 0,0001) te medijan OS koji iznosi 7,2 mjeseca u usporedbi sa 5,2 mjeseca kod placeba; sa stopom jednogodišnjeg preživljenja od 27,1% u usporedbi sa 16,6% kod placeba.
Reflux gastritis
Refluksni gastritis Ezofagitis
Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the apparent volume of distribution (Vd/F) for trifluridine and tipiracil hydrochloride was 21 L and 333 L, respectively.
Nakon jedne doze Lonsurfa (35 mg/m2) u bolesnika s uznapredovalim solidnim tumorima, prividni volumen distribucije (Vd/F) za trifluridin iznosio je 21 L, a za tipiracilklorid 333 L.
Angina pectoris Arrhythmia Palpitations
Angina pektoris
Table 5 - Adverse drug reactions reported in clinical trials in patients treated with Lonsurf System Organ Class (MedDRA)a
Tablica 5 - Nuspojave prijavljene u bolesnika liječenih s Lonsurfom u kliničkim ispitivanjima
Visual acuity reduced Vision blurred Diplopia
Slabljenje vidne oštrine Zamućenje vida Dvoslike
In the pharmacokinetic (PK) analyses of the multiple dose administration of Lonsurf (35 mg/m2/dose, twice daily for 5 days a week with 2 days rest for 2 weeks followed by a 14-day rest, repeated every 4 weeks), trifluridine area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) was approximately 3-fold higher and maximum concentration (Cmax) was approximately 2-fold higher after multiple dose administration (Day 12 of Cycle 1) of Lonsurf than after single-dose (Day 1 of Cycle 1).
Ciklus se ponovljao svaka 4 tjedna), površina ispod krivulje koncentracija vrijeme za trifluridin je od vremena 0 do zadnje mjerljive koncentracije (AUC0-zadnje) bila oko 3 puta veća, a maksimalna koncentracija (Cmax) je bila oko 2 puta veća nakon višekratne primjene (12. dan, 1. ciklus) Lonsurfa u usporedbi s vrijednostima nakon jedne doze (1. dan, 1. ciklus).
Lonsurf plus BSC (N=337)
(N=337)
• pain or discomfort in your arms or legs
• bol ili nelagoda u rukama ili nogama
Placebo plus BSC (N=170)
(N=170)
Figure 2 - Kaplan-Meier curves of progression-free survival in patients with metastatic colorectal cancer
Slika 2 - Kaplan-Meierova krivulja preživljenja bez progresije bolesti u bolesnika s metastatskim kolorektalnim karcinomom
Following multiple doses of Lonsurf (35 mg/m2/dose twice daily) in patients with advanced solid tumours, the mean times to peak plasma concentrations (tmax) of trifluridine and tipiracil hydrochloride were around 2 hours and 3 hours, respectively.
Nakon višekratnih doza lijeka Lonsurf (35 mg/m2/dozi, dva puta dnevno) u bolesnika s uznapredovalim solidnim tumorom, srednja vrijednost vremena do postizanja vršne koncentracije u plazmi (tmax) trifluridina je iznosilo oko 2 sata, a tipiracilklorida oko 3 sata.
Resumption criteriaa
Kriterij za nastavak primjenea
Hazard ratio for death, 0.68 (95% CI, 0.58-0.81) P<0.0001
Omjer hazarda za smrt, 0,68 (95% CI, 0,58-0,81) P<0,0001
• feeling dizzy, headache
• osjećaj omaglice, glavobolja
• inflammation or infection of bile ducts, increase in the diameter of the bile duct
• upala ili infekcija žučnih vodova, povećanje promjera žučnog voda
* Common terminology criteria for adverse events Table 4 - Dose reductions according to body surface area (BSA)
Common Terminology Criteria for Adverse Events, CTCAE)
Candida infection Bacterial infection Infection
Bakterijske infekcije
In total, 800 patients were randomised 2:1 to receive Lonsurf (N = 534) plus best supportive care (BSC) or matching placebo (N = 266) plus BSC. Lonsurf dosing was based on BSA with a starting dose of 35 mg/m2/dose.
Ukupno je 800 bolesnika bilo randomizirano u omjeru 2:1 ili u skupinu koja je primala Lonsurf (N=534) uz najbolju potpornu njegu (eng. best supportive care, BSC) ili u skupinu koja je primala placebo uz BSC.
Paraesthesia Burning sensation Lethargy Dizziness Headache
Parestezija Osjećaj pečenja Letargija Omaglica Glavobolja
NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg tablets trifluridine/tipiracil
NAZIV LIJEKA Lonsurf 15 mg/6,14 mg tablete trifluridin/tipiracil
Lonsurf is not recommended for use in patients with baseline moderate or severe hepatic impairment (National Cancer Institute [NCI] Criteria Group C and D defined by total bilirubin > 1.5 x ULN), as a higher incidence of Grade 3 or 4 hyperbilirubinaemia is observed in patients with baseline moderate hepatic impairment, although this is based on very limited data (see section 5.2).
National Cancer Institute, NCI] definirano ukupnim bilirubinom > 1,5 x gornja granica normale) budući da je zabilježena povećana incidencija hiperbilirubinemije 3. ili 4. stupnja u bolesnika s umjerenim oštećenjem jetre na početku liječenja, iako se ovo temelji na vrlo ograničenim podacima (vidjeti dio
This is because it may harm your unborn baby.
Vašem nerođenom djetetu.
Dyspnoea
Disfonija
Figure 4 - Kaplan-Meier curves of progression-free survival in patients with metastatic gastric cancer
Slika 4 - Kaplan-Meierova krivulja preživljenja bez progresije bolesti u bolesnika s metastatskim karcinomom želuca
Titanium dioxide (E171) Iron oxide red (E172) Magnesium stearate
Željezov oksid crveni (E172) Magnezijev stearat
NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg tablets trifluridine/tipiracil
NAZIV LIJEKA Lonsurf 20 mg/8,19 mg tablete trifluridin/tipiracil
Renal failure Cystitis noninfective Micturition disorder Haematuria Leukocyturia
Septički šokb Infektivni enteritis Infekcija pluća Infekcija bilijarnog trakta
No adjustment of the starting dose is recommended in patients with mild hepatic impairment (see section 5.2).
Nije potrebno prilagoditi početnu dozu u bolesnika s blagim oštećenjem jetre (vidjeti dio 5.2).
Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the oral clearance (CL/F) for trifluridine and tipiracil hydrochloride were 10.5 L/hr and 109 L/hr, respectively.
Nakon primjene jedne doze Lonsurfa (35 mg/m2) u bolesnika s uznapredovalim solidnim tumorom, klirens nakon peroralne primjene (CL/F) za trifluridin je bio 10,5 L/h, a za tipiracilklorid 109 L/h.
Lonsurf 15 mg/6.14 mg film-coated tablets
Lonsurf 15 mg/6,14 mg filmom obložene tablete
Lonsurf has been shown to cause embryo-foetal lethality and embryo-foetal toxicity in pregnant rats when given at dose levels lower than the clinical exposure.
Doze Lonsurfa manje od onih koje su propisane su pokazale embrio-fetalnu smrtnost i embrio-fetalnu toksičnost u skotnih ženki štakora.
BATCH NUMBER Lot
13. BROJ SERIJE Lot:
Skin exfoliation Urticaria
Eksfolijacije kože
• feeling of numbness or pins and needles in hands or feet
• osjećaj utrnulosti ili osjećaj trnaca i bockanja u šakama ili stopalima
Сервие Медикал ЕООД Тел.
anti-VEGF lijekove i anti-EGFR lijekove.
Each film-coated tablet contains 15 mg trifluridine and 6.14 mg tipiracil (as hydrochloride).
Svaka filmom obložena tableta sadrži 15 mg trifluridina i 6,14 mg tipiracila (u obliku tipiracilklorida).
a Kaplan-Meier estimates b Methodology of Brookmeyer and Crowley c Stratified log-rank test (strata: KRAS status, time since diagnosis of first metastasis, region)
<0,0001 (1-strano i 2-strano) a Procijenjeno pomoću Kaplan-Meierove metode b Brookmeyerovom i Crowleyjevom metodom c Stratificirani log-rank test (stratifikacija: KRAS status, vrijeme od dijagnoze prve metastaze, regija) Slika 1 - Kaplan-Meierova krivulja ukupnog preživljenja bolesnika s metastatskim kolorektalnim karcinomom
Febrile neutropenia Lymphopenia
Febrilna neutropenija
• you have kidney problems
• ako imate poteškoće s bubrezima
NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets
Lonsurf 15 mg/6,14 mg filmom obložene tablete Lonsurf 20 mg/8,19 mg filmom obložene tablete
Each film-coated tablet contains 20 mg trifluridine and 8.19 mg tipiracil (as hydrochloride).
Svaka filmom obložena tableta sadrži 20 mg trifluridina i 8,19 mg tipiracila (u obliku tipiracilklorida).
Figure 3- Kaplan-Meier curves of overall survival in patients with metastatic gastric cancer
Slika 3 - Kaplan-Meierova krivulja ukupnog preživljenja bolesnika s metastatskim karcinomom želuca
mild (CrCl = 60 to 89 mL/min) or moderate (CrCl = 30 to 59 mL/min) renal impairment subgroups.
Ukupna incidencija štetnih događaja slična je u podskupinama s normalnom funkcijom bubrega (CrCl ≥ 90 mL/min), blagim (CrCl = 60 to 89 mL/min) ili umjerenim (CrCl = 30 to 59 mL/min) oštećenjem funkcije bubrega.
• rash, itchy or flaky skin
• osip, svrbež ili perutanje kože,
The effect was also maintained in regorafenib-naive patients (hazard ratio: 0.69, 95% CI [0.57 to 0.83]).
Učinak je bio također održan i kod bolesnika koji nisu prije primili regorafenib (omjer hazarda 0,69; 95% CI [0,57 do 0,83]).
Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the mean times to peak plasma concentrations (tmax) of trifluridine and tipiracil hydrochloride were around 2 hours and 3 hours, respectively.
Nakon primjene jedne doze Lonsurfa (35 mg/m2) u bolesnika s uznapredovalim solidnim tumorom, srednja vrijednost vremena postizanja vršne koncentracije u plazmi (tmax) trifluridina je iznosila oko 2 sata, a tipiracilklorida oko 3 sata.
Lonsurf 20 mg/8.19 mg film-coated tablets Hypromellose
Lonsurf 20 mg/ 8,19 mg mg filmom obložene tablete Hipromeloza
Hyperkalaemia
Hiperkalijemija Hipokalijemija
• inflammation or infection in your bladder
• upala ili infekcije mokraćnog mjehura
Servier Pharma, d. o. o. Tel.: +385 (0)1 3016 222
Tel.: +385 (0)1 3016 222
Lonsurf 15 mg/6.14 mg film-coated tablets Hypromellose
Lonsurf 15 mg/ 6,14 mg filmom obložene tablete Hipromeloza
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg trifluridine and 6.14 mg of tipiracil (as hydrochloride).
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 15 mg trifluridina i 6,14 mg tipiracila (u obliku tipiracilklorida).
• mouth pain or problems
• bol ili poteškoće u ustima
Pyrexia
Kseroza
NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
NAZIV LIJEKA Lonsurf 20 mg/8,10 mg filmom obložene tablete trifluridin/tipiracil
15 mg/6.14 mg 20 mg/8.19 mg
20 mg/8,19
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg trifluridine and 8.19 mg of tipiracil (as hydrochloride).
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 20 mg trifluridina i 8,19 mg tipiracila (u obliku tipiracilklorida).
Pancytopenia Granulocytopenia Monocytopenia Erythropenia Leukocytosis Monocytosis
Monocitopenija Eritropenija
Abdominal pain Constipation Stomatitis Oral disorder
Bolovi u abdomenu Konstipacija Stomatitis
After oral administration of Lonsurf with [14C]-tipiracil hydrochloride, at least 27% of the administered tipiracil hydrochloride was absorbed and 50% of the total radioactivity dose measured into faeces, suggestive of moderate gastrointestinal absorption of tipiracil hydrochloride.
Nakon peroralne primjene Lonsurfa s [14C]tipiracilkloridom, najmanje je 27% primjenjenog tipiracilklorida apsorbirano i 50% ukupne
Gastric cancer
Karcinom želuca
• bloating, passing gas, indigestion
• nadutost, vjetrovi, probavne smetnje
• swelling or pain in your joints or big toes
• oticanje ili bol u zglobovima ili palcima
Lonsurf 20 mg/8.19 mg film-coated tablets
Lonsurf 20 mg/8,19 filmom obložene tablete
• Severe renal impairment (CrCl below 30 mL/min) or end stage renal disease Administration is not recommended in patients with severe renal impairment or end stage renal disease as there are no data available for these patients (see section 4.4).
Primjena lijeka se ne preporučuje u bolesnika s teškim oštećenjem bubrega ili s terminalnom fazom bubrežne bolesti jer nema dostupnih podataka za ove bolesnike (vidjeti dio 4.4).
Hypokalaemia
Anemija
System Organ Class (MedDRA)a
Servier Danmark A/S
NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg film-coated tablets trifluridine/tipiracil
Lonsurf 15 mg/6,14 mg filmom obložene tablete trifluridin/tipiracil
Servier Laboratories (Ireland) Ltd. Tel: +353 (0)1 663 8110
Tel: +353 (0)1 663 8110