natgillin/translations-raw huggingface dataset:
Based on this trial and population pharmacokinetic analysis of data derived from clinical trials in various tumour types, it is concluded, that adjustments to the starting dose in patients with mild (eGFR 60-89 mL/min/1.73m²), moderate (eGFR 30-59 mL/min/1.73m²), or severe (eGFR 15-29 mL/min/1.73m²) renal impairment are not necessary, but patients with severe impairment should be monitored (see “Population pharmacokinetic analysis in special populations” below and section 4.2).
Na temelju ovog ispitivanja i populacijske farmakokinetičke analize podataka proizašlih iz kliničkih ispitivanja na različitim vrstama tumora, zaključeno je da nisu potrebne prilagodbe početne doze u bolesnika s blagim (eGFR 60-89 ml/min/1,73 m2), umjerenim (eGFR
Cystitis
Cistitis
One film-coated tablet contains 235 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 235 mg laktoze (u obliku hidrata).
Odds Ratio (OR) (95%CI) p-value
Omjer izgleda (OR) (95%CI) p-vrijednost
Body weight Plasma exposure (AUCτ,ss) was increased by 26% for a 42 kg patient (2.5
Izloženost u plazmi (AUCτ,ss) se povećala za 26% kod bolesnika s 42 kg (2,5 percentila), te smanjila za 22% kod bolesnika od 95 kg (97,5 percentila) u odnosu na bolesnike s 62 kg (medijan tjelesne težine bolesnika u ukupnoj bolesničkoj populaciji).
Subjects with severe renal impairment (n=8; eGFR 15-29 mL/min/1.73m², according to the
Ispitanici s umjerenim oštećenjem bubrega (n=8; eGFR 30-59 ml/min/1,73 m2, sukladno jednadžbi MDRD, od engl.
What GIOTRIF looks like and contents of the pack GIOTRIF 20 mg film-coated tablets are white to yellowish and round shaped.
GIOTRIF 20 mg filmom obložene tablete su bijele do žućkaste boje i okruglog oblika.
Adjustments to the starting dose are not necessary in patients with mild (eGFR 60-89 mL/min/1.73m²), moderate (eGFR 30-59 mL/min/1.73m²) or severe (eGFR 15-29 mL/min/1.73m²) renal impairment.
Prilagodbe početne doze nisu potrebne u bolesnika s blagim (eGFR 60-89 ml/min/1,73 m2), umjerenim
Rhinorrhoea
Rinoreja
GIOTRIF 20 mg film-coated tablets Hypromellose (E464) Macrogol 400
GIOTRIF 20 mg filmom obložene tablete hipromeloza (E464) makrogol 400 titanijev dioksid (E171) talk (E553b)
Dose escalation
Povećanje doze
PFS Months (median)
Preživljenje bez progresije (PFS) Mjeseci (medijan)
Pemetrexed/ Cisplatin (N=57)
Pemetreksed/ cisplatin (N=57)
GIOTRIF 20 mg film-coated tablets One film-coated tablet contains 20 mg afatinib (as dimaleate).
GIOTRIF 20 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 20 mg afatiniba (u obliku afatinibdimaleata).
MedDRA Preferred Term
Preporučeni izrazi po MedDRA-i
• Inflammation of the lining of the bladder with burning sensations during urination and frequent,
• Upala sluznice mjehura s osjećajem pečenja tijekom mokrenja, te česta, hitna potreba za mokrenjem
White to yellowish, round, biconvex and bevel-edged film-coated tablet debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other.
Bijela do žućkasta, okrugla, bikonveksna filmom obložena tableta sa ukošenim rubovima i utisnutom oznakom “T20” na jednoj strani i logom tvrtke Boehringer Ingelheim na drugoj.
Table 2: Summary of ADRs per frequency category
Tablica 2: Pregled nuspojava na lijek po kategoriji učestalosti
Reporting the frequency of patients with all causality AEs Includes Paronychia, Nail infection, Nail bed infection Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Oral mucosa erosion, Mucosal erosion, Mucosal ulceration Includes group of rash preferred terms Includes Acne, Acne pustular, Dermatitis acneiform
*prijavljene su učestalosti za bolesnike s nuspojavama svih kauzalnosti uključuje paronihiju, infekciju nokta, infekciju ležišta nokta uključuje stomatitis, aftozni stomatitis, upalu sluznice, ulceraciju usta, eroziju sluznice usta, eroziju sluznice, ulceraciju sluznice uključuje skupinu preporučenih termina za osip uključuje akne, pustulozne akne, akneiformni dermatitis
Metabolism and nutrition disorders Decreased appetite
Preporučeni izrazi po MedDRA-i Infekcije i infestacije Paronihija Poremećaji metabolizma i prehrane Smanjeni apetit
Hazard Ratio/ Odds Ratio (95%CI)
Omjer hazarda (HR)/ Omjer izgleda (OR) (95% CI)
Skin and subcutaneous tissue disorders Rash
Poremećaji kože i potkožnog tkiva Osip
The efficacy results at the time of the primary analysis of OS including all randomized patients are summarized in Figure 2 and Table 10.
Na slici 2 i u tablici 10 sažeti su rezultati djelotvornosti u trenutku primarne analize ukupnog preživljenja koja je uključivala sve randomizirane bolesnike.
GIOTRIF (40 mg/day) N=160
GIOTRIF (40 mg/dan) N=392
INFORMATION IN BRAILLE GIOTRIF 20 mg
16. PODACI NA BRAILLEOVOM PISMU GIOTRIF 20 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 20 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTER za 20 mg
GIOTRIF 20 mg film-coated tablets
GIOTRIF 20 mg filmom obložene tablete
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 20 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ALUMINIJSKA VREĆICA za 20 mg
Gastrointestinal disorders Diarrhoea Stomatitis
Proljev Stomatitis Mučnina Povraćanje
Hepatic impairment
Poremećaji nokata
- The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400,
- Drugi sastojci su laktoza hidrat, mikrokristalična celuloza (E460), koloidni bezvodni silicijev dioksid (E551), krospovidon vrste A, magnezijev stearat (E470b), hipromeloza (E464), makrogol 400, titanijev dioksid (E171), talk (E553b), polisorbat 80 (E433).
GIOTRIF 30 mg film-coated tablets One film-coated tablet contains 30 mg afatinib (as dimaleate).
GIOTRIF 30 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 30 mg afatiniba (u obliku afatinibdimaleata).
INFORMATION IN BRAILLE GIOTRIF 50 mg
16. PODACI NA BRAILLEOVOM PISMU GIOTRIF 50 mg
GIOTRIF 40 mg film-coated tablets One film-coated tablet contains 40 mg afatinib (as dimaleate).
GIOTRIF 40 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 40 mg afatiniba (u obliku afatinibdimaleata).
What GIOTRIF looks like and contents of the pack GIOTRIF 30 mg film-coated tablets are dark blue and round shaped.
GIOTRIF 30 mg filmom obložene tablete su tamnoplave boje i okruglog oblika.
GIOTRIF 50 mg film-coated tablets One film-coated tablet contains 50 mg afatinib (as dimaleate).
GIOTRIF 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 50 mg afatiniba (u obliku afatinibdimaleata).
Each film-coated tablet contains 20 mg of afatinib (as dimaleate).
Jedna filmom obložena tableta sadrži 20 mg afatiniba (u obliku afatinibdimaleata).
Hazard Ratio (HR) (95%CI) p-value
Omjer hazarda (HR)/ Omjer izgleda (OR) (95%CI) p-vrijednost
Pemetrexed/ Cisplatin (N=47)
Pemetreksed/ cisplatin (N=47)
INFORMATION IN BRAILLE GIOTRIF 30 mg
16. PODACI NA BRAILLEOVOM PISMU GIOTRIF 30 mg
GIOTRIF 20 mg film-coated tablets afatinib
GIOTRIF 20 mg filmom obložene tablete afatinib
MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/010
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/879/010
GIOTRIF 50 mg film-coated tablets EU/1/13/879/010
GIOTRIF 50 mg filmom obložene tablete EU/1/13/879/010
GIOTRIF 30 mg film-coated tablets
GIOTRIF 30 mg filmom obložene tablete
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 30 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ALUMINIJSKA VREĆICA za 30 mg
GIOTRIF 40 mg film-coated tablets
GIOTRIF 40 mg filmom obložene tablete
What GIOTRIF looks like and contents of the pack GIOTRIF 40 mg film-coated tablets are light blue and round shaped.
GIOTRIF 40 mg filmom obložene tablete su svijetloplave boje i okruglog oblika.
• Stomach pain, indigestion, heartburn
• Bol u želucu, probavne tegobe, žgaravica
INFORMATION IN BRAILLE GIOTRIF 40 mg
16. PODACI NA BRAILLEOVOM PISMU GIOTRIF 40 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 50 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTER za 50 mg
NAME OF THE MEDICINAL PRODUCT GIOTRIF 20 mg tablets afatinib
NAZIV LIJEKA GIOTRIF 20 mg tablete afatinib
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 20 mg)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (KUTIJA ZA BLISTER za 20 mg)
Severe hepatic impairment
Teško oštećenje jetre
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 40 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTER za 40 mg
What GIOTRIF looks like and contents of the pack GIOTRIF 50 mg film-coated tablets are dark blue and oval shaped.
GIOTRIF 50 mg filmom obložene tablete su tamnoplave boje i ovalnog oblika.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 40 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ALUMINIJSKA VREĆICA za 40 mg
GIOTRIF 50 mg film-coated tablets
GIOTRIF 50 mg filmom obložene tablete
Each film-coated tablet contains 50 mg of afatinib (as dimaleate).
Jedna filmom obložena tableta sadrži 50 mg afatiniba (u obliku afatinibdimaleata).
Dark blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other.
Tamnoplava, okrugla, bikonveksna filmom obložena tableta s ukošenim rubovima i utisnutom oznakom “T30” na jednoj strani i logom tvrtke Boehringer Ingelheim na drugoj.
NAME OF THE MEDICINAL PRODUCT GIOTRIF 50 mg tablets afatinib
NAZIV LIJEKA GIOTRIF 50 mg tablete afatinib
Each film-coated tablet contains 40 mg of afatinib (as dimaleate).
Jedna filmom obložena tableta sadrži 40 mg afatiniba (u obliku afatinibdimaleata).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 50 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ALUMINIJSKA VREĆICA za 50 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 30 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTER za 30 mg
GIOTRIF 30 mg film-coated tablets afatinib
GIOTRIF 30 mg filmom obložene tablete afatinib
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 50 mg)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (KUTIJA ZA BLISTER za 50 mg)
NAME OF THE MEDICINAL PRODUCT GIOTRIF 30 mg tablets afatinib
NAZIV LIJEKA GIOTRIF 30 mg tablete afatinib
GIOTRIF 30 mg film-coated tablets EU/1/13/879/004
GIOTRIF 30 mg filmom obložene tablete EU/1/13/879/004
They are debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other.
Imaju utisnutu oznaku “T20” na jednoj strani i logo tvrtke Boehringer Ingelheim na drugoj.
GIOTRIF 20 mg film-coated tablets EU/1/13/879/001
GIOTRIF 20 mg filmom obložene tablete EU/1/13/879/001
Each film-coated tablet contains 30 mg of afatinib (as dimaleate).
Jedna filmom obložena tableta sadrži 30 mg afatiniba (u obliku afatinibdimaleata).
NAME OF THE MEDICINAL PRODUCT GIOTRIF 40 mg tablets afatinib
NAZIV LIJEKA GIOTRIF 40 mg tablete afatinib
6.9 vs. 3.4 HR 0.70; p=0.0220 values presented for GIOTRIF vs. chemotherapy, p-value based on logistic regression b p-value for time to deterioration based on stratified log-rank test
vrijednosti predstavljene za GIOTRIF naspram kemoterapije; p-vrijednost temeljena na logističkoj regresiji p-vrijednost za vrijeme do pogoršanja temeljena na stratificiranom log-rank testu
GIOTRIF 40 mg film-coated tablets afatinib
GIOTRIF 40 mg filmom obložene tablete afatinib
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 30 mg)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (KUTIJA ZA BLISTER za 30 mg)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 20 mg film-coated tablets afatinib
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GIOTRIF 20 mg filmom obložene tablete afatinib
Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.
Tamnoplava, ovalna, bikonveksna filmom obložena tableta s ukošenim rubovima i utisnutom oznakom “T50” na jednoj strani i logom tvrtke Boehringer Ingelheim na drugoj.
They are debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.
Imaju utisnutu oznaku “T50” na jednoj strani i logo tvrtke Boehringer Ingelheim na drugoj.
GIOTRIF 40 mg film-coated tablets EU/1/13/879/007
GIOTRIF 40 mg filmom obložene tablete EU/1/13/879/007
Dyspepsia
Dispneja
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg afatinib (as dimaleate).
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 20 mg afatiniba (u obliku afatinibdimaleata).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 40 mg)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (KUTIJA ZA BLISTER za 40 mg)
GIOTRIF 50 mg film-coated tablets afatinib
GIOTRIF 50 mg filmom obložene tablete afatinib
They are debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other.
Imaju utisnutu oznaku “T30” na jednoj strani i logo tvrtke Boehringer Ingelheim na drugoj.
Light blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.
Svijetloplava, okrugla, bikonveksna filmom obložena tableta s ukošenim rubovima i utisnutom oznakom “T40” na jednoj strani i logom tvrtke Boehringer Ingelheim na drugoj.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 30 mg film-coated tablets afatinib
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GIOTRIF 30 mg filmom obložene tablete afatinib
OS Months (median)
Medijan OS-a (mjeseci)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 40 mg film-coated tablets afatinib
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GIOTRIF 40 mg filmom obložene tablete afatinib
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg afatinib (as dimaleate).
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 30 mg afatiniba (u obliku afatinibdimaleata).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 40 mg afatinib (as dimaleate).
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 40 mg afatiniba (u obliku afatinibdimaleata).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 50 mg film-coated tablets afatinib
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GIOTRIF 50 mg filmom obložene tablete afatinib
Conjunctivitis Dry eye
Konjunktivitis Sindrom suhog oka Keratitis
MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/879/001
Liver function test abnormalities
Poremećaji testova jetrene funkcije
They are debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.
Imaju utisnutu oznaku “T40” na jednoj strani i logo tvrtke Boehringer Ingelheim na drugoj.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg afatinib (as dimaleate).
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 50 mg afatiniba (u obliku afatinibdimaleata).
The primary endpoint was PFS as assessed by central independent review; secondary endpoints included OS and ORR.
Primarni ishod je bio PFS na temelju središnje nezavisne procjene; sekundarni ishodi su uključivali ukupno preživljenje (engl. overall survival, OS) i stopu objektivnog odgovora (engl. objective response rate, ORR).
MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/004
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/879/004
titanium dioxide (E171), talc (E553b), polysorbate 80 (E433).
GIOTRIF 30, 40 i 50 mg filmom obložene tablete hipromeloza (E464) makrogol 400 titanijev dioksid (E171) talk (E553b) polisorbat 80 (E433) indigo carmine aluminijev hidroksid (E132)
MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/007
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/879/007
Respiratory, thoracic and mediastinal disorders Rhinorrhoea
Poremećaji dišnog sustava, prsišta i sredoprsja Epistaksa
Cough
Spol
MA (EU)Number
Broj (EU) odobrenja (Zaštićeno) ime
Immediate Packaging
Put primjene Unutarnje pakovanje Veličina pakovanja
For any of the following:
Za bilo što od sljedećeg:
Events (%)
događaji (%)
Do not try to treat yourself with other medicines.
Nemojte pokušavati sami sebe liječiti drugim lijekovima.
30th January 2020
30. siječnja
After opening
Nakon otvaranja
Bavencio can cause harm to your unborn baby.
Bavencio može naštetiti Vašem nerođenom djetetu.
• Do not co-administer other medicinal products through the same intravenous line.
• Nemojte istodobno primjenjivati druge lijekove kroz istu intravensku liniju.
(18, not estimable)
(18, nije se moglo procijeniti)
• give you other medicines in order to prevent complications and reduce your symptoms,
• dati druge lijekove kako bi se spriječile komplikacije i ublažili simptomi
• Brief introduction to avelumab (indication and purpose of this tool)
• Kratak uvod u avelumab (indikacija i svrha ove kartice)
Your doctor will decide how many treatments you need.
Vaš će liječnik odlučiti koliko puta trebate primiti terapiju.
You will receive Bavencio in a hospital or clinic, under the supervision of an experienced doctor.
Bavencio ćete primati u bolnici ili klinici, pod nadzorom iskusnog liječnika.
• Feeling cold
• osjećaj hladnoće
• you have had an organ transplant.
• imate presađen organ.
Bavencio is used in adults to treat:
Bavencio se primjenjuje u odraslih za liječenje:
If you experience any of these symptoms when taking Bavencio do not try to treat them on your own with other medicines.
Ako osjetite bilo koje od ovih simptoma dok uzimate Bavencio, ne pokušavajte ih sami liječiti drugim lijekovima.
Time to response (TTR)
Vrijeme do odgovora (TTR)
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja do primjene odgovornost su korisnika.
You will have blood tests during your treatment and your doctor will monitor your weight before and during treatment.
Obavljat ćete krvne pretrage tijekom liječenja i liječnik će pratiti Vašu tjelesnu težinu prije i tijekom liječenja.
Seek urgent medical attention if you experience inflammation in any part of your body or if you have any of the following signs or symptoms, or if they get worse.
Potražite hitnu medicinsku pomoć ako dobijete upalu u bilo kojem dijelu tijela ili ako imate bilo koji od sljedećih znakova ili simptoma ili ako se oni pogoršavaju.
Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland
Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Švicarska
Do not drive or use machines after you have received Bavencio if you are not feeling well enough.
Nemojte upravljati vozilima ili raditi sa strojevima nakon što ste primili Bavencio ako se ne osjećate dovoljno dobro.
The patient educational material should contain
Edukacijski materijal za bolesnika mora sadržavati
• Inflammatory reaction of the whole body (Systemic inflammatory response syndrome)
• upalna reakcija cijelog tijela (sindrom sistemskog upalnog odgovora)
Total systemic clearance increases with body weight.
Ukupni sistemski klirens povećava se s tjelesnom težinom.
Some side effects may happen weeks or months after your last dose.
Neke nuspojave mogu nastati tjednima ili mjesecima nakon zadnje doze.
Contents of the pack and other information What Bavencio contains
Sadržaj pakiranja i druge informacije Što Bavencio sadrži
(10.2, not estimable)
(10,2; nije se moglo procijeniti)
Suspected pneumonitis should be confirmed with radiographic imaging.
Sumnju na pneumonitis treba potvrditi rendgenskom snimkom.
Blood tests and weight checks:
Krvne pretrage i provjere tjelesne težine:
Any partially used or empty vials have to be discarded.
Sve djelomično upotrijebljene ili prazne bočice treba baciti.
The treatment is directed to the management of symptoms.
Liječenje je usmjereno na zbrinjavanje simptoma.
Bavencio has not been studied in children and adolescents below 18 years of age.
Bavencio nije ispitan u djece i adolescenata mlađih od 18 godina.
Dose escalation or reduction is not recommended.
Ne preporučuje se povisivati ili snižavati dozu.
Your doctor will check your general health before and during treatment with Bavencio.
Liječnik će provjeriti Vaše opće zdravlje prije i tijekom liječenja lijekom Bavencio.
What Bavencio is and what it is used for
Što je Bavencio i za što se koristi
Patients excluded from clinical studies
Bolesnici isključeni iz kliničkih ispitivanja
* 1-sided p-value based on stratified log-rank.
* jednostrana p-vrijednost na temelju stratificiranog log-ranga.
Depending on how your body responds to treatment, your doctor may decide to continue giving you these medicines before all of your Bavencio treatments.
Ovisno o odgovoru Vašeg tijela na liječenje, liječnik može odlučiti da Vam nastavi davati ove lijekove svaki put prije nego što primite Bavencio.
Since it is known that antibodies can be secreted in human milk, a risk to the newborns/infants cannot be excluded.
Budući da je poznato da se protutijela mogu izlučivati u majčino mlijeko, ne može se isključiti rizik za novorođenče/dojenče.
Bavencio is for intravenous infusion only.
Bavencio je samo za intravensku infuziju.
The safety and efficacy of Bavencio in children and adolescents below 18 years of age have not been established.
Sigurnost i djelotvornost lijeka Bavencio u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
Other medicines and Bavencio
Drugi lijekovi i Bavencio
BICR: Blinded Independent Central Review; CI: Confidence interval; NE: Not estimable.
Blinded Independent Central Review); CI: raspon pouzdanosti; NE: ne može se procijeniti.
• you have an autoimmune disease (a condition where the body attacks its own cells);
• imate autoimunu bolest (stanje u kojem tijelo napada vlastite stanice)
Some side effects may not have symptoms and may only be discovered through blood tests.
Neke nuspojave ne moraju imati simptome i mogu se otkriti samo krvnim pretragama.
Avelumab is expected to be distributed in the systemic circulation and to a lesser extent in the extracellular space.
Očekuje se da će se avelumab distribuirati u sistemsku cirkulaciju i u manjoj mjeri u izvanstanični prostor.
Do not freeze or shake the diluted solution.
Ne zamrzavati ili tresti razrijeđenu otopinu.
The volume of distribution at steady state was 4.72 L.
Volumen distribucije u stanju dinamičke ravnoteže iznosio je 4,72 l.
IHC-MCV tumour status
IHC-MCV tumorski status
2.3 months).
13 mjeseci).
• The card should also prompt to enter contact details of the physician and include a warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Bavencio.
• Kartica također treba imati prostor za unos podataka za kontakt liječnika i uključivati poruku s upozorenjem za zdravstvene radnike koji u bilo kojem trenutku liječe bolesnika, uključujući hitne situacije, da bolesnik primjenjuje Bavencio.
If you suffer from any of these you should seek urgent medical attention:
Ako primijetite neki od ovih simptoma, morate potražiti hitnu medicinsku pomoć:
It is not recommended to use avelumab during pregnancy unless the clinical condition of the woman requires treatment with avelumab.
Ne preporučuje se primjenjivati avelumab tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje avelumabom.
Please note that in some cases symptoms may be delayed, and may develop after your last dose.
Imajte na umu da se ovi simptomi ponekad kasno javljaju i mogu se razviti i nakon zadnje doze.
Bavencio acts on your immune system and may cause inflammation in parts of your body (see section 2).
Bavencio djeluje na Vaš imunološki sustav i može uzrokovati upalu u raznim dijelovima tijela (pogledajte dio 2).