natgillin/translations-raw huggingface dataset:
In vitro data suggest that cannabidiol is an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, UGT1A9 and UGT2B7-mediated activity at clinically relevant concentrations.
In vitro podaci sugeriraju da je kanabidiol inhibitor aktivnosti posredovane putem CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, UGT1A9 i UGT2B7 u klinički značajnim koncentracijama.
10 mg/kg/day, 62% to 77% on 20 mg/kg/day, 30% to 41% on placebo; p=0.0009 for 10 mg/kg/day and p=0.0018 and 0.0136 for 20 mg/kg/day vs. placebo).
62% do 77% na 20 mg/kg/dan, 30% do 41% na placebu; p = 0,0009 za 10 mg/kg/dan i p = 0,0018 i 0,0136 za 20 mg/kg/dan u usporedbi s placebom).
Table 5: Drug interactions between cannabidiol and concomitant antiepileptic drugs Concomitant AED Influence of AED on cannabidiol Influence of cannabidiol on AED Clobazam
Tablica 5: Interakcije između kanabidiola i istovremeno primijenjenih antiepileptika
The metabolite 7-carboxy-cannabidiol (7-COOH-CBD) is also an inhibitor of UGT1A1, UGT1A4 and UGT1A6-mediated activity in vitro.
Metabolit 7-karboksikanabidiol (7-COOH-CBD) je također inhibitor aktivnosti posredovane putem UGT1A1, UGT1A4 i UGT1A6 in vitro.
Table 3: Primary and ≥ 50% responder key secondary outcome measures and subgroup analysis in LGS studies
Tablica 3: Primarne i ključne sekundarne mjere ishoda za bolesnike s ≥ 50% odgovorom i analize podskupina u LGS ispitivanjima
What Epidyolex looks like and contents of the pack Epidyolex is a clear, colourless to yellow oral solution.
Epidyolex je prozirna, bezbojna do žuta oralna otopina.
Table 4 summarises the primary endpoint of percent reduction from baseline in convulsive seizures, and the key secondary measure of proportion of patients with at least a 50% reduction in convulsive seizure frequency, as well as results of the subgroup analysis for these outcome measures in patients treated with concomitant clobazam.
Tablica 4 prikazuje sažetak primarne mjere ishoda postotnog smanjenja konvulzivnih napadaja u odnosu na početnu vrijednost i ključnu sekundarnu mjeru ishoda, udio bolesnika s najmanje 50% smanjenja učestalosti konvulzivnih napadaja, kao i rezultate analize podskupina za ove mjere ishoda u bolesnika istovremeno liječenih klobazamom.
Baseline transaminase elevations
Povišenja početnih vrijednosti transaminaza
- Two 1 ml syringes graduated in 0.05 ml increments (each 0.05 ml increment corresponds to 5 mg cannabidiol) - Two 5 ml syringes graduated in 0.1 ml increments (each 0.1 ml increment corresponds to 10 mg cannabidiol)
- dvjema štrcaljkama od 5 ml s oznakama na svakih 0,1 ml (svakih 0,1 ml odgovara količini od 10 mg kanabidiola)
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release GW Pharma (International) B.V., Databankweg 26
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet GW Pharma (International) B.V., Databankweg 26
Discard unused portion 8 weeks after first opening Date of first opening:
Preostali sadržaj baciti 8 tjedana nakon prvog otvaranja.
Refined sesame oil
Rafinirano sezamovo ulje Bezvodni etanol
INFORMATION IN BRAILLE epidyolex
16. PODACI NA BRAILLEOVOM PISMU epidyolex
Compared with placebo, cannabidiol was associated with an increase in the number of drop seizure-free days during the treatment period in each trial, equivalent to 3.3 days per 28 days (10 mg/kg/day) and 5.5 to 7.6 days per 28 days (20 mg/kg/day).
U usporedbi s placebom, kanabidiol je povezan s povećanjem broja dana bez astatskih napadaja tijekom razdoblja liječenja u svakom od ispitivanja; ekvivalentno 3,3 dana na 28 dana (10 mg/kg/dan) odnosno 5,5 do 7,6 na 28 dana (20 mg/kg/dan).
Patients with sustained transaminase elevations of greater than 5 times the ULN should also have treatment discontinued.
Bolesnici s neprekidno povišenim transaminazama većim od 5 puta GGN također trebaju prestati s uzimanjem kanabidiola.
Data for study GWPCARE2 and the with clobazam subgroup are presented as percent reduction from baseline estimated from a negative binomial regression analysis.
Podaci za ispitivanje GWPCARE2 i podskupine sa klobazamom predstavljeni su kao postotno smanjenje u odnosu na početak procijenjeno analizom negativne binomne regresije.
Interaction resulting in an increase in exposure of the active metabolite 7-OH-CBD in HV* studies.
Interakcija koja dovodi do porasta izloženosti aktivnom metabolitu 7-OH-CBD u ispitivanjima na zdravim dobrovoljcima.a
Table 4: Primary and ≥ 50% responder key secondary outcome measures and subgroup analysis in DS studies
Tablica 4: Primarne i ključne sekundarne mjere ishoda za bolesnike s ≥ 50% odgovorom i analize podskupina u DS ispitivanjima
LIST OF EXCIPIENTS Contains refined sesame oil, ethanol and strawberry flavour components (including benzyl alcohol).
POPIS POMOĆNIH TVARI Sadrži rafinirano sezamovo ulje, etanol i komponente za okus jagode (uključujući benzilni alkohol).
• If your dose is 1 ml (100 mg) or less, you should use the smaller 1 ml syringe.
• Ako je Vaša doza 1 ml (100 mg) ili manja, trebali biste upotrebljavati manju štrcaljku od
Table 3 summarises the primary endpoint of percent reduction from baseline in drop seizures, and the key secondary measure of proportion of patients with at least a 50% reduction in drop seizure frequency, as well as results of the subgroup analysis for these outcome measures in patients treated with concomitant clobazam.
Tablica 3 prikazuje sažetak primarne mjere ishoda postotnog smanjenja astatskih napadaja u odnosu na početak i ključnu sekundarnu mjeru ishoda, udio bolesnika s najmanje 50% smanjenja učestalosti astatskih napadaja, kao i rezultate analize podskupina za ove mjere ishoda u bolesnika istovremeno liječenih klobazamom.
Each ml of oral solution contains 100 mg of cannabidiol.
Jedan ml oralne otopine sadrži 100 mg kanabidiola.
GWPCARE4 Placebo 20 mg/kg/day p=0.0043
GWPCARE4 Placebo 20 mg/kg/dan p = 0,0043
Key secondary endpoints were the proportion of patients with at least a 50% reduction in drop seizure frequency, the percentage change from baseline in total seizure frequency, and Subject/Caregiver Global Impression of Change at the last visit.
Ključne sekundarne mjere ishoda su bile udio bolesnika s barem 50%-nim smanjenjem učestalosti astatskih napadaja, postotna promjena u odnosu na početak u ukupnoj učestalosti napadaja, te globalni dojam promjene ispitanika/njegovatelja na zadnjem posjetu.
Risk Factors for Hepatocellular injury Concomitant Valproate and Clobazam, Dose of cannabidiol and Baseline Transaminase Elevations
Istovremeno uzimanje valproata i klobazama, doza kanabidiola i povišenja početnih vrijednosti transaminaza
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
Placebo 10 mg/kg/day p=0.0332
Placebo 10 mg/kg/dan p = 0,0332
In juvenile rats, administration of cannabidiol for 10 weeks (subcutaneous doses of 0 or 15 mg/kg on postnatal days [PNDs] 4-6 followed by oral administration of 0, 100, 150, or 250 mg/kg on PNDs 7-77
U mladih štakora, primjena kanabidiola tijekom 10 tjedana (supkutana doza od 0 ili 15 mg/kg u dane nakon poroda [engl. postnatal days, PND] 4-6 praćena oralnom primjenom 0, 100, 150 ili 250 mg/kg na dane nakon poroda 7-77, dovela je do porasta tjelesne težine, kasnijeg spolnog dozrijevanja mužjaka, neurološko-bihevioralnih učinaka, smanjene mineralne gustoće kostiju i vakuolizacije jetrenih hepatocita.
Greater improvements in overall condition, as measured by Global Impression of Change scores at the last visit, were reported by caregivers and patients with both doses of cannabidiol (76% on 10 mg/kg/day, 80% for each group on 20 mg/kg/day, 31% to 46% on placebo; p=0.0005 for 10 mg/kg/day and p<0.0001 and 0.0003 for 20 mg/kg/day vs. placebo).
Veća poboljšanja u ukupnom stanju, mjereno rezultatima Globalnog dojma promjene na zadnjem posjetu, prijavljena su i od njegovatelja i bolesnika s obje doze kanabidiola (76% na 10 mg/kg/dan, 80% za svaku skupinu na 20 mg/kg/dan, 31% do 46% na placebu; p = 0,0005 za 10 mg/kg/dan i p< 0,0001 i 0,0003 za 20 mg/kg/dan u usporedbi s placebom).
In rats, the EFD study evaluated doses of 75, 150, or 250 mg/kg/day.
Kod štakora je ispitivanje embriofetalnog razvoja procjenjivalo doze od 75, 150 ili 250 mg/kg/dan.
GWPCARE3 10 mg/kg/day p=0.0016
GWPCARE3 10 mg/kg/dan p = 0,0016
Data for the with clobazam subgroup are presented as percent reduction from baseline estimated from a negative binomial regression analysis.
Podaci za podskupine s klobazamom predstavljeni su kao postotno smanjenje u odnosu na početnu vrijednost procijenjeno analizom negativne binomne regresije.
GWPCARE4 20 mg/kg/day p=0.0135
GWPCARE4 20 mg/kg/dan p = 0,0135
Placebo 20 mg/kg/day p=0.0784
Placebo 20 mg/kg/dan p = 0,0784
• If your dose is more than 1 ml (100 mg), you should use the larger 5 ml syringe.
• Ako je Vaša doza veća od 1 ml (100 mg), trebali biste upotrebljavati veću štrcaljku od 5 ml.
Increased seizure frequency
Povećana učestalost napadaja
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).
Dose response
Odgovor na dozu
In vitro assessment of interaction with UGT enzymes In vitro data suggest that cannabidiol is a reversible inhibitor of UGT1A9 and UGT2B7-mediated activity at clinically relevant concentrations.
In vitro podaci sugeriraju kako je kanabidiol reverzibilni inhibitor aktivnosti posredovane putem UGT1A9 i UGT2B7 u klinički značajnim koncentracijama.
Cannabidiol is a substrate for CYP3A4, CYP2C19, UGT1A7, UGT1A9 and UGT2B7.
Kanabidiol je supstrat za CYP3A4, CYP2C19, UGT1A7, UGT1A9 i UGT2B7.
Cannabidiol is a substrate for UGT1A7, UGT1A9 and UGT2B7.
Kanabidiol je supstrat za UGT1A7, UGT1A9 i UGT2B7.
The UGT isoforms responsible for the phase II conjugation of cannabidiol are UGT1A7, UGT1A9 and UGT2B7.
Izoforme UGT odgovorne za metabolizam kanabidiola faze II su UGT1A7, UGT1A9 i UGT2B7.
DROP SEIZURES PER 28 DAYS Percentage Reduction from Baselinea
KONVULZIVNI NAPADAJI NA 28 DANA
Drug interaction studies
Ispitivanja interakcija lijekova
In each trial, patients receiving cannabidiol experienced a greater median percentage reduction in total seizures compared with placebo (53% 10 mg/kg/day, 64% to 66% 20 mg/kg/day, 25% for each placebo group; p=0.0025 for 10 mg/kg/day and p<0.0001 for each 20 mg/kg/day group vs. placebo).
U svakom od ispitivanja, bolesnici koji su dobivali kanabidiol imali su veći medijan postotka smanjenja ukupnih napadaja u usporedbi s placebom (53% 10 mg/kg/dan, 64% do 66% 20 mg/kg/dan, 25% za svaku skupinu na placebu; p = 0,0025 za 10 mg/kg/dan i p < 0,0001 za svaku skupinu od 20 mg/kg/dan u usporedbi s placebom).
If the calculated dose is 100 mg (1 ml) or less, the smaller 1 ml oral syringe should be used.
Ako je izračunata doza 100 mg (1 ml) ili manje, treba upotrebljavati manju štrcaljku za usta od 1 ml.
How to take Epidyolex
Kako uzimati Epidyolex
In each trial, patients receiving cannabidiol experienced a greater percentage reduction in total seizures compared with placebo (66% 10 mg/kg/day, 54% to 58% 20 mg/kg/day, 27% to 41% placebo; p=0.0003 for 10 mg/kg/day and p=0.0341 and 0.0211 for 20 mg/kg/day vs. placebo).
U svakom od ispitivanja, bolesnici koji su dobivali kanabidiol imali su veće postotno smanjenje ukupnih napadaja u usporedbi s placebom (66% 10 mg/kg/dan, 54% do 58% 20 mg/kg/dan, 27% do 41% na placebu; p = 0,0003 za 10 mg/kg/dan i p = 0,0341 i 0,0211 za 20 mg/kg/dan u usporedbi s placebom).
p<0.0001c ≥ 50% REDUCTION IN DROP SEIZURES (RESPONDER ANALYSIS) Percentage of ≥ 50% Responders, p-valued GWPCARE3 Placebo
Postotak bolesnika s ≥ 50% odgovorom, p-vrijednostd GWPCARE3 Placebo
b For study GWPCARE1, overall data are presented as estimated median difference and p-value from a Wilcoxon rank-sum test. Data for study GWPCARE2 and the with clobazam subgroup are estimated from a negative binomial regression analysis.
b Za ispitivanje GWPCARE1 ukupni podaci prikazani su kao procijenjeni medijan razlike i p-vrijednost iz Wilcoxonovog testa sume rangova.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children
POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
• A plastic bag containing two 5 ml oral syringes and a bottle adaptor A spare syringe of each size is provided in the pack in case the first one is damaged or lost.
U pakiranju se nalazi rezervna štrcaljka od svake veličine, za slučaj da se prva ošteti ili izgubi.
Haematologic abnormalities
Hematološke abnormalnosti
If the calculated dose is more than 100 mg (1 ml), the larger 5 ml oral syringe should be used.
Ako je izračunata doza veća od 100 mg (1 ml), treba upotrebljavati veću štrcaljku za usta od 5 ml.
- The other ingredients are refined sesame oil, anhydrous ethanol, sucralose and strawberry flavour (including benzyl alcohol)
- Ostali sastojci su rafinirano sezamovo ulje, bezvodni etanol, sukraloza i okus jagode
CONVULSIVE SEIZURES PER 28 DAYS Percentage Reduction from Baselinea GWPCARE2
Postotno smanjenje u odnosu na Početaka GWPCARE2
Dose adjustment or discontinuation of valproate or dose adjustment of clobazam should be considered if transaminase elevations occur.
U slučaju povišenja transaminaza, treba razmisliti o prilagodbi doze ili prekidu uzimanja valproata ili prilagodbi doze klobazama.
A NOAEL of 15 mg/kg/day was established.
Utvrđena je razina bez uočenih štetnih učinaka (NOAEL) od 15 mg/kg/dan.
Moderate 1.25 mg/kg twice daily (2.5 mg/kg/day)
Umjereno 1,25 mg/kg dvaput dnevno (2,5 mg/kg/dan)
Very common Decreased appetite Common
Smanjeni apetit
Very common Pyrexia, Fatigue
Pireksija, umor
Based on a healthy volunteer study, elevated levels (3- to 4-fold) of N-desmethylclobazam (an active metabolite of clobazam) can occur when combined with cannabidiol, likely mediated by CYP2C19 inhibition.
N-desmetilklobazama (aktivni metabolit klobazama) kad se kombinira s kanabidiolom, što je vjerojatno posredovano inhibicijom CYP2C19.
Cannabidiol was associated with an increase in the percentage of subjects experiencing a greater than or equal to 75% reduction in convulsive seizure frequency during the treatment period in each trial (36% 10 mg/kg/day cannabidiol, 25% for each 20 mg/kg/day cannabidiol group, 10% to 13% placebo).
Dodatne sekundarne mjere ishoda u podskupinama bolesnika istovremeno liječenih klobazamom Kanabidiol je povezan s povećanjem postotka ispitanika koji su doživjeli smanjenje učestalosti konvulzivnih napadaja do 75% ili više u razdoblju liječenja tijekom oba ispitivanja (36% 10 mg/kg/dan kanabidiola, 25% za svaku skupinu na kanabidiolu od 20 mg/kg/dan, 10% do 13% na placebu).
b Overall data are presented as estimated median difference and p-value from a Wilcoxon rank-sum test. Data for the with clobazam subgroup are estimated from a negative binomial regression analysis.
b Ukupni podaci su prikazani kao procijenjeni medijan razlike i p-vrijednost iz Wilcoxonovog testa sume rangova.
Cannabidiol was associated with an increase in the percentage of subjects experiencing a greater than or equal to 75% reduction in drop seizure frequency during the treatment period in each trial (11% 10 mg/kg/day cannabidiol, 31% to 36% 20 mg/kg/day cannabidiol, 3% to 7% placebo).
Dodatne sekundarne mjere ishoda u podskupinama bolesnika istovremeno liječenih klobazamom Kanabidiol je povezan s povećanjem postotka ispitanika koji su doživjeli smanjenje učestalosti astatskih napadaja do 75% ili više u razdoblju liječenja tijekom oba ispitivanja (11% 10 mg/kg/dan kanabidiola, 31% do 36% 20 mg/kg/dan kanabidiola, 3% do 7% na placebu).
1 mg/kg twice daily (2 mg/kg/day)
1 mg/kg dvaput dnevno (2 mg/kg/dan)
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of oral solution contains 100 mg cannabidiol
NAVOĐENJE DJELATNE(IH) TVARI Jedan ml oralne otopine sadrži 100 mg kanabidiola.
Remove the child-resistant cap on the bottle by pushing the cap down whilst turning the cap anti-clockwise.
Skinite zatvarač siguran za djecu s bočice tako da pritisnete zatvarač dok ga okrećete u smjeru suprotnom od kretanja kazaljki na satu.
20 mg/kg/day p=0.0123
20 mg/kg/dan p = 0,0123
20 mg/kg/day p=0.0299
20 mg/kg/dan p = 0,0299
5 mg/kg twice daily (10 mg/kg/day)
5 mg/kg dvaput dnevno (10 mg/kg/dan)
Each ml of solution contains:
Pomoćne tvari s poznatim učinkom Jedan ml otopine sadrži:
Excretion
Izlučivanje
10 mg/kg/day p=0.0030
10 mg/kg/dan p = 0,0030
10 mg/kg/day p=0.0095
10 mg/kg/dan p = 0,0095
p=0.0032c ≥ 50% REDUCTION IN CONVULSIVE SEIZURES (RESPONDER ANALYSIS) Percentage of ≥ 50% Responders, p-valued GWPCARE2
p = 0,0032c ≥ 50% SMANJENJE KONVULZIVNIH
How to store Epidyolex
Kako čuvati Epidyolex
a For study GWPCARE1, overall data are presented as median percent reduction from baseline.
CI = 95% interval pouzdanosti a Za ispitivanje GWPCARE1 ukupni podaci prikazani su kao medijan postotnog smanjenja u odnosu na početak.
0.5 mg/kg twice daily (1 mg/kg/day)
0,5 mg/kg dvaput dnevno (1 mg/kg/dan)
CI=95% confidence interval.
CI = 95% interval pouzdanosti a Podaci za ukupnu populaciju prikazani su kao medijan postotnog smanjenja u odnosu na početnu vrijednost.
NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution cannabidiol
Epidyolex 100 mg/ml oralna otopina kanabidiol
20 mg/kg/day p=0.0069
20 mg/kg/dan p = 0,0069
Cough
Kašalj
20 mg/kg/day p=0.0047
20 mg/kg/dan p = 0,0047
Concomitant AED treatments
Istovremeno primijenjeni antiepileptik
20 mg/kg/day p=0.0006
20 mg/kg/dan p = 0,0006
Very common Diarrhoea, Vomiting
Proljev, povraćanje
PHARMACEUTICAL FORM Oral solution
OBLIK Oralna otopina
Abuse
Zlouporaba
PHARMACEUTICAL FORM AND CONTENTS Oral solution
OBLIK I SADRŽAJ
Two 5 ml oral syringes with bottle adaptor
Dvije štrcaljke za usta od 1 ml s adapterom za bočicu Dvije štrcaljke za usta od 5 ml s adapterom za bočicu
listed in Appendix V.
PRILOG III.
2.5 mg/kg twice daily (5 mg/kg/day)
2,5 mg/kg dvaput dnevno (5 mg/kg/dan)
Severe
Teško
Instructions for the oral use of Epidyolex
Upute za primjenu Epidyolexa kroz usta
Drug interaction studies with AEDs
In vitro procjena interakcije s UGT enzimima
If you or your patient stop taking Epidyolex
Ako Vi ili bolesnik uzmete više Epidyolexa nego što ste trebali
Renal impairment
Oralna otopina
Discontinuation
Prekid primjene
2 mg/kg twice daily (4 mg/kg/day)* *Higher doses of cannabidiol may be considered in patients with severe hepatic impairment where the potential benefits outweigh the risks.
* Veće se doze kanabidiola mogu razmotriti u bolesnika s teškim oštećenjem funkcije jetre kad moguće koristi nadilaze rizike.
Open-label data
Podaci iz ispitivanja otvorenog tipa
What Epidyolex contains - The active substance is cannabidiol.
- Djelatna tvar je kanabidiol.
• or are planning to have a baby.
• ili planirate imati dijete.
• think you may be pregnant
• mislite da biste mogli biti trudni
1 week (7 days)
1 tjedan (7 dana)
30th June, 2021
30. lipnja 2021.
Continue until the full dose is evenly and completely dispersed.
Nastavite dok se cijela doza ravnomjerno i potpuno ne raspodijeli.
Your second injection will be given 3 weeks after the first injection.
Druga injekcija bit će Vam primijenjena 3 tjedna nakon prve injekcije.
Lesion size (longest dimension)
Veličina lezije (najduža dimenzija)
o Instruction on how to behave after accidental transmission.
o Upute o tome kako se ponašati nakon slučajnog izlaganja.
Previous systemic treatment for melanoma was allowed but not required.
Prethodno sustavno liječenje melanoma je bilo dozvoljeno, ali ne neophodno.
Study 005/05
Ispitivanje 005/05
Reproductive and development toxicity
Reproduktivna i razvojna toksičnost
Overall response rate (% CR, % PR)
Učestalost sveukupnog odgovora (% CR, % PR)
Time to response (median)
Vrijeme do odgovora (medijan)
Overall, ninety eight per cent (98%) of these adverse reactions reported were mild or moderate in severity.
Sveukupno, devedeset osam posto (98%) od tih prijavljenih nuspojava bile su blage ili umjerene po ozbiljnosti.
Imlygic also works by helping your immune system to recognise and destroy tumours throughout your body.
Imlygic također djeluje tako da pomaže Vašem imunološkom sustavu prepoznati i uništiti tumore u cijelom Vašem tijelu.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
U nedostatku ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
• Imlygic must not be refrozen once it has thawed.
• Imlygic se ne smije ponovo zamrzavati jednom kada se odmrzne.
All subsequent treatment visits (including reinitiation)
Svi sljedeći posjeti (uključujući ponovno uvođenje liječenja)
Autoimmune reactions
Autoimune reakcije
No overall differences in safety or efficacy were observed between elderly (≥ 65 years old) and younger adult patients.
Nije opažena razlika u sigurnosti ili djelotvornosti između starijih (u dobi od ≥ 65 godina) i mlađih odraslih bolesnika.
Cover any exposed wounds before administering.
Pokrijte sve izložene rane prije primjene.
This medicine contains genetically modified organisms.
Ovaj lijek sadrži genetski modificirane organizme.
2 weeks after previous treatment
2 tjedna nakon prethodnog liječenja
Talk to your healthcare professional about suitable methods of contraception.
Razgovarajte sa svojim zdravstvenim radnikom o odgovarajućim metodama kontracepcije.
Number of Patients at Risk
Broj bolesnika pod rizikom
Women of childbearing potential/contraception
Žene reproduktivnog potencijala/kontracepcija
- If you have any further questions, ask your healthcare professional (doctor or nurse).
- Ako imate dodatnih pitanja, obratite se svom zdravstvenom radniku (liječniku ili medicinskoj sestri).
All patients
Svi bolesnici
Granulomatous dermatitis
Granulomatozni dermatitis
These symptoms generally resolve within the first 72 hours after treatment.
Ovi simptomi obično nestaju unutar prvih 72 sata nakon primjene lijeka.
Number of Subjects at Risk:
Broj ispitanika izloženih riziku:
Do NOT shake.
NE tresite.
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC
JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC
Imlygic may harm your unborn baby.
Imlygic može naštetiti Vašem nerođenom djetetu.
The educational programme is aimed to inform about important risks associated with IMLYGIC:
Cilj edukacijskog programa je informirati o važnim rizicima povezanima s lijekom IMLYGIC:
Imlygic may cause autoimmune reactions (an over-reaction of the body's immune system).
Imlygic može uzrokovati autoimune reakcije (pretjerana reakcija imunološkog sustava tijela).
It may contain white, visible, variously shaped, virus-containing particles.
Može sadržavati bijele, vidljive, različito oblikovane čestice koje sadrže virus.
What Imlygic is and what it is used for
Što je Imlygic i za što se koristi
Cellulitis and systemic bacterial infection have been reported.
Prijavljeni su celulitis i sustavna bakterijska infekcija.
Avoid contact with skin, eyes or mucous membranes.
Izbjegavajte kontakt s kožom, očima ili membranama sluznice.
Metabolism/elimination
Metabolizam/eliminacija
• Low red blood cell numbers (anaemia)
• Nizak broj crvenih krvnih stanica (anemija)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 December 2015
Datum prvog odobrenja: 16. prosinca 2015.
Keeping wounds clean and dressed can help prevent these types of infections.
Održavanje rana čistima i pokrivenima zavojima može spriječiti ovakve vrste infekcija.
The median duration of exposure to Imlygic was 23 weeks (5.3 months).
Medijan trajanja izloženosti lijeku Imlygic bio je 23 tjedna (5,3 mjeseca).
Previously treated patients
Prethodno liječeni bolesnici
Exploratory subgroups
Eksploratorne podskupine
Twenty six (26) patients were exposed to Imlygic for at least one year.
Dvadeset šest (26) bolesnika bilo je izloženo lijeku Imlygic najmanje jednu godinu.
Time to treatment failure (median)
Vrijeme do neuspjeha liječenja (medijan)