natgillin/translations-raw huggingface dataset:
In order to further confirm the safety and efficacy of rucaparib in the treatment of platinum sensitive, relapsed or progressive, BRCA mutated (germline and/ or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, the MAH should submit the results of study CO-338-043 (ARIEL4), a phase 3, multicentre, open-label, randomised study evaluating the efficacy and safety of rucaparib versus chemotherapy for treatment of relapsed ovarian cancer.
Za nadaljnjo potrditev varnosti in učinkovitosti rukapariba za zdravljenje bolnic z na platino občutljivim, recidivnim ali napredujočim epitelijskim rakom jajčnikov, jajcevodov ali primarnim peritonealnim rakom visoke stopnje, nastalim zaradi mutacij na genu BRCA (germinalnih in/ali somatskih), bo imetnik dovoljenja za promet z zdravilom predložil rezultate študije CO-338-043 (ARIEL4), odprte, multicentrične, randomizirane študije 3.
Rubraca 200 mg film-coated tablets Rubraca 250 mg film-coated tablets Rubraca 300 mg film-coated tablets
Rubraca 200 mg filmsko obložene tablete Rubraca 250 mg filmsko obložene tablete Rubraca 300 mg filmsko obložene tablete
Effect of P-gp and BCRP inhibitors on rucaparib PK cannot be ruled out.
Učinkov zaviralcev P-gp in BCRP na farmakokinetiko rukapariba ni mogoče izključiti.
• Rubraca 300 mg film-coated tablets are yellow, oval, film-coated tablets with “C3” marked on one side.
• Rubraca 300 mg filmsko obložene tablete so rumene, ovalne filmsko obložene tablete z oznako "C3" na eni strani.
• Rubraca 200 mg film-coated tablets are blue, round, film-coated tablets with “C2” marked on one side.
• Rubraca 200 mg filmsko obložene tablete so modre, okrogle filmsko obložene tablete z oznako "C2" na eni strani.
Rucaparib induced CYP1A2, and down regulated CYP2B6 and CYP3A4 in human hepatocytes at clinically relevant exposures.
Rukaparib je zaviral CYP1A2, in je pri klinično pomembnih izpostavljenostih v človeških human hepatocitih CYP2B6 in CYP3A4 reguliral navzdol.
• Do not breast-feed during treatment with Rubraca, and for two weeks after taking the last dose.
Dojenje - Med zdravljenjem z zdravilom Rubraca in še dva tedna po zadnjem odmerku ne smete dojiti.
Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinumsensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Zdravilo Rubraca je indicirano kot monoterapija za vzdrževalno zdravljenje odraslih bolnic z na platino občutljivim recidivnim epitelijskim rakom jajčnikov, jajcevodov ali primarnim peritonealnim rakom visoke stopnje, ki se (povsem ali deloma) odziva na kemoterapijo na osnovi platine.
Blood samples for 94% (186/196) of the tBRCA patients were evaluated using a central blood germline BRCA (gBRCA) test. Based on these results, 70% (130/186) of the tBRCA patients had a gBRCA mutation and 30% (56/186) had a somatic BRCA mutation.
Na podlagi teh rezultatov je 70 % (130/186) bolnic s tBRCA imelo mutacijo gBRCA, 30 % (56/186) pa jih je imelo somatsko mutacijo BRCA.
Moreover, according to its mechanism of action, rucaparib may impact human fertility.
Glede na mehanizem delovanja lahko rukaparib zmanjša plodnost pri človeku.
(95% CI)
HR (95-% IZ)
Children unde 18 years of age should not be given Rubraca, This medicine has not beem studied in this age group.
Otroci, mlajši od 18 let, ne smejo uporabljati zdravila Rubraca.
What you need to know before you take Rubraca Do not take Rubraca:
Kaj morate vedeti, preden boste vzeli zdravilo Rubraca
No starting dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Pri bolnicah z blago ali zmerno okvaro ledvic prilagoditev začetnega odmerka ni potrebna (glejte poglavje 5.2).
Patients with mild renal impairment (N=149; CLcr between 60 and 89 mL/min, as estimated by the Cockcroft-Gault method) and those with moderate renal impairment (N=76; CLcr between 30 and 59 mL/min) showed approximately 15% and 33% higher steady-state AUC, respectively, compared to patients with normal renal function (N=147; CLcr greater than or equal to 90 mL/min).
Populacijska farmakokinetična analiza je bila opravljena z namenom ocene učinka okvare ledvic na očistek rukapariba pri bolnicah, ki so prejemale rukaparib v odmerku 600 mg dvakrat na dan. Bolnice z blago okvaro ledvic (N = 149; CLcr med 60 in 89 ml/min, ocenjeno z Cockcroft-Gaultovo metodo) in bolnice z zmerno okvaro ledvic (N = 76; CLcr med 30 in 59 ml/min) so imele približno 15 % in 33% višjo vrednost AUC v stanju dinamičnega ravnovesja v primerjavi z bolnicami z normalnim delovanjem ledvic (N = 147; CLcr večji ali enak 90 ml/min).
Patients could not have received prior rucaparib or other PARP inhibitor therapy.
Bolnice predhodno niso smele prejemati rukapariba ali drugega zdravljenja z zaviralcem PARP.
What Rubraca is used for
Za kaj uporabljamo zdravilo Rubraca
Enzymes responsible for rucaparib metabolism have not been identified.
Encimov, ki so odgovorni za presnavljanje rukapariba, še niso prepoznali.
In vitro, rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
In vitro je rukaparib je močan zaviralec MATE1 in MATE2-K, zmeren zaviralec OCT1 in šibek zaviralec OCT2.
No cardiac effects were observed with oral dosing of rucaparib in repeat-dose toxicology studies at a rucaparib Cmax comparable to that observed in patients.
V študijah toksičnosti s ponavljajočimi peroralnimi odmerki rukapariba niso opazili učinkov na srce pri vrednosti Cmax rukapariba, primerljivi z vrednostjo pri bolnicah.
Rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
Rukaparib je močan zaviralec MATE1 in MATE2-K, zmeren zaviralec OCT1 in šibek zaviralec OCT2.
Myelodysplastic syndrome / Acute myeloid leukaemia
Mielodisplastični sindrom/akutna mieloična levkemija
In the tBRCA population, 31% of patients (40/130) in the rucaparib group and 35% of patients (23/66) in the placebo group had measurable disease at baseline.
V populaciji tBRCA je 31 % bolnic (40/130) v skupini, ki je prejemala rukaparib, in 35 % bolnic
Rash maculo-papular, Palmarplantar erythrodysaesthesia syndrome, Erythema
Pogosti makulopapulozni izpuščaj, sindrom palmarno-plantarne eritrodisestezije, eritem
• Rubraca 250 mg film-coated tablets are white, diamond-shaped, film-coated tablets with “C25” marked on one side.
• Rubraca 250 mg filmsko obložene tablete so bele filmsko obložene tablete v obliki romba z oznako "C25" na eni strani.
There is no specific treatment in the event of Rubraca overdose, and symptoms of overdose are not established.
Specifičnega zdravljenja za preveliko odmerjanje zdravila Rubraca ni.
In patients with moderate renal impairment (CLcr of 30-59 mL/min), frequencies of some adverse reactions increased: Grade 3 or 4 anaemia (31%), Grade 3 or 4 thrombocytopenia (12%), and Grade 3 fatigue/asthenia (15%) were higher than in patients with mild renal impairment (CLcr > 59-80 mL/min) or normal renal function (CLcr > 80 mL/min) (21%, 5%, and 8%).
Pri bolnicah z zmerno ledvično okvaro (vrednost CLcr 30-59 ml/min) so bile pogostnosti nekaterih neželenih učinkov večje: anemija 3. ali 4. stopnje (31 %), trombocitopenija 3. ali 4. stopnje (12 %) in utrujenost/astenija 3. stopnje (15 %) so bile pogostejše kot pri bolnicah z blago ledvično okvaro
No starting dose adjustment is required in patients with mild hepatic impairment (see section 5.2).
Pri bolnicah z blago okvaro jeter prilagoditev začetnega odmerka ni potrebna (glejte poglavje 5.2).
Rucaparib increased midazolam Cmax by 1.13 fold (90% CI: 0.95 to 1.36) and AUCinf by 1.38 fold (90% CI: 1.13 to 1.69).
Rukaparib je povišal Cmax midazolama za 1,13-krat (90-odstotni IZ: 0,95 do 1,36,) AUCinf pa za 1,38krat (90-odstotni IZ: 1,13 do 1,69).
Rucaparib increased S-warfarin Cmax by 1.05 fold (90% CI: 0.99 to 1.12) and AUC0-96h by 1.49 fold (90% CI: 1.40 to 1.58), respectively.
Rukaparib je povišal Cmax S-varfarina za 1,05-krat (90-odstotni IZ: 0,99 do 1,12), AUC0-96 h pa za 1,49-krat (90-odstotni IZ: 1,40 do 1,58).
Rucaparib increased omeprazole Cmax by 1.09 fold (90% CI: 0.93 to 1.27) and AUCinf by 1.55 fold (90% CI: 1.32 to 1.83).
Rukaparib je povišal Cmax omeprazola za 1,09-krat (90-odstotni IZ: 0,93 do 1,27), AUCinf pa za 1,55krat (90-odstotni IZ: 1,32 do 1,83).
Blue, 11 mm, round film-coated tablet, debossed with “C2”.
Modra, okrogla filmsko obložena tableta premera 11 mm z oznako "C2".
There are no animal studies on the excretion of rucaparib in breast milk.
Študij na živalih o izločanju rukapariba v mleko ni. Ni znano, ali se rukaparib in/ali njegovi presnovki izločajo v materino mleko.
Thus, the risk for clinically significant QTcF increase from baseline (i.e. > 20 msec) is low.
Zato je tveganje za klinično pomembno podaljšanje intervala QTcF od izhodišča (t.j.
Dysgeusia, Dizziness
Občasni disgevzija, omotica
No dose adjustment is recommended for co-administered medicinal products that are P-gp substrates.
Za sočasna zdravila, ki so substrati P-gp, prilagajanje odmerka ni priporočeno.
Median overall survival - months (95% CI)
Mediano celokupno preživetje meseci (95-% IZ) Cenzorirano N (%)
No formal studies of rucaparib in patients with renal impairment have been conducted.
Formalnih študij z rukaparibom pri bolnicah z motnjami v delovanju ledvic niso izvedli.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving rucaparib.
Bolnicam v rodni dobi je treba odsvetovati nosečnost v obdobju, ko prejemajo rukaparib.
Hepatobiliary disorders Very common
Zelo pogosti anemijab
Grade 3 without other signs of liver dysfunction Monitor LFTs weekly until resolution to Grade ≤ 2
Stopnja 3 brez drugih znakov nepravilnega delovanja jeter
Missed doses If a dose is missed, the patient should resume taking Rubraca with the next scheduled dose.
Če bolnica izpusti odmerek zdravila Rubraca, mora vzeti naslednji odmerek ob običajnem času.
White, 11 x 15 mm, diamond-shaped film-coated tablet, debossed with “C25”.
Bela filmsko obložena tableta v obliki romba velikosti 11 x 15 mm z oznako "C25".
Hepatic impairment No formal studies of rucaparib in patients with hepatic impairment have been conducted.
Formalnih študij z rukaparibom pri bolnicah z motnjami v delovanju jeter niso izvedli.
Fertility studies have not been conducted with rucaparib.
Študij plodnosti z rukaparibom niso opravili.
• Rubraca is not recommended during pregnancy.
- Uporaba zdravila Rubraca med nosečnostjo ni priporočljiva.
In the ITT population, 38% of patients (141/375) in the rucaparib group and 35% of patients (66/189) in the placebo group had measurable disease at baseline.
V populaciji ITT je 38 % bolnic (141/375) v skupini, ki je prejemala rukaparib, in 35 % bolnic
Description of selected adverse reactions
Opis izbranih neželenih učinkov Hematološka toksičnost
vomiting, anaemia, abdominal pain, dysgeusia, ALT elevations, AST elevations, decreased appetite, diarrhoea, thrombocytopenia and creatinine elevations.
Neželeni učinki, ki so se pojavili pri ≥ 20 % bolnic, ki so prejemale rukaparib, so bili navzea, utrujenost/astenija, bruhanje, anemija, bolečine v trebuhu, disgevzija, zvišanje ravni ALT, zvišanje ravni AST, zmanjšanje teka, driska, trombocitopenija in zvišanje ravni kreatinina.
Always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika, farmacevta ali medicinske sestre.
Rubraca 250 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 250 mg of rucaparib.
Rubraca 250 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje rukaparibijev kamsilat v količini 250 mg rukapariba.
Population PK analysis suggested that concomitant use of PPIs is unlikely to have clinically meaningful impact on rucaparib PK. A firm conclusion cannot be made regarding the effect of co-administration of rucaparib and PPIs because dose level and time of administration have not been documented in detail for the PPIs.
Dokončne ugotovitve o učinku sočasnega dajanja rukapariba in zaviralcev protonske črpalke ni mogoče podati, saj ravni odmerka in časa dajanja zaviralcev protonske črpalke niso podrobno dokumentirali.
There is no requirement for BRCA testing prior to using Rubraca for the maintenance treatment of adult patients with relapsed high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) who are in a complete or partial response to platinum-based chemotherapy.
Pred uporabo zdravila Rubraca za vzdrževalno zdravljenje odraslih bolnic z recidivnim epitelijskim rakom jajčnikov (EOC - epithelial ovarian cancer), jajcevodov (FTC - fallopian tube cancer) ali primarnim peritonealnim rakom (PPC - primary peritoneal cancer) visoke stopnje, ki se povsem ali deloma odzivajo na kemoterapijo na osnovi platine, ni potrebno testiranje za mutacijo BRCA.
Rubraca 300 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 300 mg of rucaparib.
Rubraca 300 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje rukaparibijev kamsilat v količini 300 mg rukapariba.
Prior bevacizumab therapy was reported for 22% of patients who received rucaparib and 23% of patients who received placebo.
in pri 23 % bolnic, ki so prejemale placebo, so poročali o predhodnem zdravljenju z bevacizumabom.
Management
Uravnavanje
• If you get any side effects, talk to your doctor, pharmacist or nurse.
• Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Nausea, Vomiting, Diarrhoea, Dyspepsia, Abdominal pain
Zelo pogosti navzea, bruhanje, driska, dispepsija, bolečine v trebuhu
Photosensitivity reaction, Rash, Rash maculo-papular, Palmarplantar erythrodysaesthesia syndrome
izpuščaj, makulopapulozni izpuščaj, sindrom palmarnoplantarne eritrodisestezije
Rubraca 200 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 200 mg of rucaparib.
Rubraca 200 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje rukaparibijev kamsilat v količini, ki ustreza 200 mg rukapariba.
The clearance ranged from 13.9 to 18.4 L/hour, following a single intravenous dose of rucaparib 12 mg to 40 mg.
MOčistek je po enkratnem intravenskem odmerku rukapariba od 12 mg do 40 mg znašal od 13,9 do 18,4 l/uro.
Dysgeusia, Dizziness,
Zelo pogosti disgevzija, omotica
- Rubraca 300 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), and iron oxide yellow (E172).
Rubraca 300 mg filmsko obložene tablete polivinilalkohol (E1203), titanov dioksid (E171), makrogol 4000 (E1521), smukec (E553b) in rumeni železov oksid (E172).
Tablet coating Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000 (E1521)
Obloga tablete polivinilalkohol (E1203) titanov dioksid (E171) makrogol 4000 (E1521) smukec (E553b)
- Rubraca 250 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), and talc (E553b)
Rubraca 250 mg filmsko obložene tablete polivinilalkohol (E1203), titanov dioksid (E171), makrogol 4000 (E1521) in smukec (E553b).
Rubraca 300 mg film-coated tablets rucaparib This medicine is subject to additional monitoring.
Rubraca 200 mg filmsko obložene tablete Rubraca 250 mg filmsko obložene tablete Rubraca 300 mg filmsko obložene tablete rukaparib Za to zdravilo se izvaja dodatno spremljanje varnosti.
Anaemiab, Thrombocytopeniab, Neutropeniab
Zelo pogosti anemijab, trombocitopenijab, nevtropenijab,
How to take Rubraca
Kako jemati zdravilo Rubraca
You may get sunburn more easily during treatment with Rubraca.
Med zdravljenjem z zdravilom Rubraca lahko hitreje dobite sončne opekline.
• Tablet coating: - Rubraca 200 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), brilliant blue FCF aluminium lake (E133) and indigo carmine aluminium lake (E132).
Rubraca 200 mg filmsko obložene tablete polivinilalkohol (E1203), titanov dioksid (E171), makrogol 4000 (E1521), smukec (E553b), briljantno modro FCF (E133) in indigotin (E132).
500 mg twice daily (two 250 mg tablets twice daily)
600 mg dvakrat na dan (dve 300-miligramski tableti dvakrat na dan) Prvo zmanjšanje odmerka 500 mg dvakrat na dan (dve 250-miligramski tableti dvakrat na dan) Drugo zmanjšanje odmerka 400 mg dvakrat na dan (dve 200-miligramski tableti dvakrat na dan) Tretje zmanjšanje odmerka 300 mg dvakrat na dan (ena 300-miligramska tableta dvakrat na dan)
• red patches on the skin
- rdeče lise na koži Poročanje o neželenih učinkih
Adverse reactions occurring in ≥ 20% of patients receiving rucaparib were nausea, fatigue/asthenia,
Pri 22 % bolnic, ki so prejemale rukaparib,
Each tablet contains rucaparib camsylate corresponding to 250 mg rucaparib.
Ena tableta vsebuje rukaparibijev kamsilat v količini, ki ustreza 250 mg rukapariba.
Each tablet contains rucaparib camsylate corresponding to 300 mg rucaparib.
Ena tableta vsebuje rukaparibijev kamsilat v količini, ki ustreza 300 mg rukapariba.
Contraception
ZDRAVILA
Each tablet contains rucaparib camsylate corresponding to 200 mg rucaparib.
Ena tableta vsebuje rukaparibijev kamsilat v količini, ki ustreza 200 mg rukapariba.
Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube,
Zdravilo Rubraca je indicirano kot monoterapija za zdravljenje odraslih bolnic z na platino občutljivim, recidivnim ali napredujočim epitelijskim rakom jajčnikov, jajcevodov ali primarnim peritonealnim rakom visoke stopnje, nastalim zaradi mutacij na genu BRCA (germinalnih in/ali somatskih), in ki so že prejele dva ali več ciklov kemoterapije na osnovi platine in ki ne morejo prenašati nadaljnjega zdravljenja s kemoterapijo na osnovi platine.
Rubraca 300 mg film-coated tablets
Rubraca 300 mg filmsko obložena tableta
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
NALEPKA NA STEKLENIČKI
ITT populationa
Populacija ITTa
Rubraca 250 mg film-coated tablets
Rubraca 250 mg filmsko obložena tableta
Rubraca 200 mg film-coated tablets
Rubraca 200 mg filmsko obložena tableta
Rubraca 300 mg film-coated tablets rucaparib
Rubraca 300 mg filmsko obložene tablete rukaparib
Nausea, Vomiting, Diarrhoea, Abdominal pain
Pogosti navzea, bruhanje, driska, bolečine v trebuhu
Caution is recommended when rucaparib is co-administered with medicinal products that are strong inhibitors of P-gp.
Pri sočasni uporabi rukapariba in zdravil, ki so močni zaviralci P-gp, je priporočljiva previdnost.
Rubraca 250 mg film-coated tablets rucaparib
Rubraca 250 mg filmsko obložene tablete rukaparib
Rubraca contains the active substance rucaparib.
Zdravilo Rubraca vsebuje učinkovino rukaparib.
Rubraca 200 mg film-coated tablets rucaparib
Rubraca 200 mg filmsko obložene tablete rukaparib
Elderly
- srbečica
General toxicology
Splošna toksičnost
Patients who had been hospitalised for bowel obstruction in the last 3 months were excluded.
bolnic je prejemalo rukaparib v odmerku 600 mg dvakrat na dan. Bolnice, ki so bile hospitalizirane zaradi obstrukcije črevesja v 3 mesecih pred začetkom zdravljenja, so bile izključene.
Median progression-free survival - days (95% CI)
Mediano preživetje brez poslabšanja bolezni v dnevih (95odstotni IZ)
Maintenance treatment of recurrent ovarian cancer
Delež bolnic z rakom,
• diarrhoea
Bolezni živčevja
Dyspnoea
Placebo
Photosensitivity has been observed in patients treated with rucaparib.
Pri bolnicah, zdravljenih z rukaparibom, so opazili preobčutljivost na svetlobo.
In terms of safety, the side effects were considered acceptable and manageable with appropriate measures.
Z vidika varnosti se neželeni učinki štejejo za sprejemljive in jih je mogoče obvladati z ustreznimi ukrepi.
What measures are being taken to ensure the safe and effective use of Cotellic?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cotellic?
This is a summary of the European public assessment report (EPAR) for Cotellic.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cotellic.
The full EPAR and risk management plan summary for Cotellic can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Cotellic sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Cotellic
Druge informacije o zdravilu Cotellic
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cotellic's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Cotellic večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It is given at a recommended dose of 60 mg a day (3 tablets of 20 mg).
Priporočeni odmerek zdravila je 60 mg na dan (tri tablete po 20 mg).
Treatment with Cotellic is given in 28 day cycles: the tablets are taken for 21 consecutive days, followed by a 7-day break.
Zdravljenje z zdravilom Cotellic poteka v ciklusih, ki trajajo 28 dni: tablete se jemljejo 21 zaporednih dni, nato pa sledi sedemdnevni premor.
A risk management plan has been developed to ensure that Cotellic is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Cotellic je bil pripravljen načrt obvladovanja tveganj.
Treatment with Cotellic must be started and supervised by a doctor experienced in the use of cancer medicines.
Zdravljenje z zdravilom Cotellic mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
It is not intended to provide practical advice on how to use Cotellic.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The most common side effects with Cotellic (which may affect more than 1 in 5 people) are diarrhoea, rash, nausea (feeling sick), vomiting, pyrexia (fever), photosensitivity (light sensitivity) reaction, abnormal results for certain liver function tests (increased levels of alanine aminotransferase, aspartate aminotransferase) and abnormal results for an enzyme related to muscle breakdown (creatine phosphokinase).
Najpogostejši neželeni učinki zdravila Cotellic (ki lahko prizadenejo več kot 1 osebo od 5) so driska, izpuščaji, navzeja (slabost), bruhanje, pireksija (povišana telesna temperatura), fotosenzibilnostna reakcija (občutljivost na svetlobo), nenormalni rezultati določenih preiskav delovanja jeter (povečane ravni alanin-aminotransferaze in aspartat-aminotransferaze) ter nenormalni rezultati za encim, ki je povezan z razgradnjo mišic (kreatin-fosfokinazo).
What benefits of Cotellic have been shown in studies?
Kakšne koristi je zdravilo Cotellic izkazalo v študijah?
What are the risks associated with Cotellic?
Kakšna tveganja so povezana z zdravilom Cotellic?
Cotellic is available as tablets (20 mg).
Zdravilo Cotellic je na voljo v obliki tablet (20 mg).
What is Cotellic and what is it used for?
Kaj je zdravilo Cotellic in za kaj se uporablja?
Cotellic is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed.
Cotellic je zdravilo proti raku, ki se uporablja za zdravljenje odraslih z melanomom (vrsto kožnega raka), ki se je razširil na druge dele telesa ali ga ni mogoče kirurško odstraniti.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cotellic, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.