natgillin/translations-raw huggingface dataset:
• If your dose is more than 1 ml (100 mg), you should use the larger 5 ml syringe.
• Če vaš odmerek znaša več kot 1 ml (100 mg), uporabite večjo, 5-mililitrsko brizgo.
There were cases of transaminase elevations associated with hospitalisation in patients taking cannabidiol.
Pri bolnikih, ki so jemali kanabidiol, so bili zabeleženi primeri zvišanja transaminaz, zaradi katerih so bili sprejeti v bolnišnico.
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
Dajanje kanabidiola mladim podganam v obdobju 10 tednov (subkutani odmerki 0 mg/kg ali 15 mg/kg od 4. do 6. dne postnatalno, ki jim je sledilo peroralno dajanje odmerka 0 mg/kg/dan, 100 mg/kg/dan, 150 mg/kg/dan ali 250 mg/kg/dan od 7. do 77. dne postnatalno) je povzročilo povečanje telesne mase, upočasnjeno spolno dozorevanje samčkov, nevro-vedenjske učinke, povečano mineralno gostoto kosti in vakuolizacijo hepatocitov.
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).
V vsakem preskušanju so imeli bolniki, ki so prejemali kanabidiol, večji mediani odstotek zmanjšanja vseh epileptičnih napadov v primerjavi s placebom (53 % 10 mg/kg/dan, 64 % do 66 % 20 mg/kg/dan, 25 % v vsaki skupini s placebom; p = 0,0025 za 10 mg/kg/dan in p < 0,0001 za 20 mg/kg/dan v vsaki skupini v primerjavi s placebom).
NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution cannabidiol
Navodilo za uporabo Epidyolex 100 mg/ml peroralna raztopina kanabidiol
Each ml of oral solution contains 100 mg of cannabidiol.
En ml peroralne raztopine vsebuje 100 mg kanabidiola.
Contact your doctor if you are unsure of your dose or if you think your dose may need to be changed.
Če niste prepričani o pravem odmerku ali če menite, da je treba odmerek spremeniti, se obrnite na zdravnika.
736 mg refined sesame oil
79 mg brezvodnega etanola 736 mg rafiniranega sezamovega olja 0,0003 mg benzilalkohola
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 Pri študiji GWPCARE1 so celokupni podatki predstavljeni kot ocenjena mediana razlika in vrednost p iz Wilcoxonovega testa vsote rangov.
Hepatocellular injury Cannabidiol causes dose-related elevations of ALT and AST (see section 4.4).
Okvara jetrnih celic Kanabidiol povzroča od odmerka odvisno zvišanje vrednosti ALT in AST (glejte poglavje 4.4).
A NOAEL of 15 mg/kg/day was established.
Raven NOAEL je bila pri 15 mg/kg/dan.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Table 4: Primary and ≥ 50% responder key secondary outcome measures and subgroup analysis in DS studies
Preglednica 4: Primarno merila izida in ključno sekundarno merilo, delež odzivnih bolnikov z ≥ 50-% zmanjšanjem, ter analiza podskupin v študijah DS
- The other ingredients are refined sesame oil, anhydrous ethanol, sucralose and strawberry flavour (including benzyl alcohol)
- Druge sestavine zdravila so rafinirano sezamovo olje, brezvodni etanol, sukraloza in aroma jagode (vključno z benzil alkoholom).
When cannabidiol and clobazam are co-administered, bi-directional PK interactions occur.
Pri sočasnem dajanju kanabidiola in klobazama se pojavijo dvosmerne farmakokinetične interakcije.
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).
Z obema odmerkoma kanabidiola so negovalci in bolniki poročali o večjih izboljšavah splošnega stanja, ki so jih izmerili z vprašalnikom o globalnem vtisu o spremembah (Global Impression of Change) pri zadnjem obisku (76 % pri 10 mg/kg/dan, 80 % v obeh skupinah, ki sta prejemali odmerek 20 mg/kg/dan, 31 % do 46 % pri placebu; p = 0,0005 za 10 mg/kg/dan in p < 0,0001 in 0,0003 za 20 mg/kg/dan v primerjavi s placebom).
Because of potential inhibition of enzyme activity, dose reduction of substrates of UGT1A9, UGT2B7, CYP2C8, and CYP2C9 should be considered, as clinically appropriate, if adverse reactions are experienced when administered concomitantly with cannabidiol.
Če se pri sočasni uporabi s kanabidiolom pojavijo neželeni učinki, je treba zaradi možnega zaviranja encimskega delovanja razmisliti o zmanjšanju odmerka substratov UGT1A9, UGT2B7, CYP2C8 in CYP2C9, glede na klinično stanje bolnika.
- High liver enzymes (transaminases elevations) seen in blood tests, which can be a sign of liver injury, have been reported in patients receiving Epidyolex - People taking this medicine can have thoughts of harming or killing themselves.
- Pri bolnikih, ki so prejemali zdravilo Epidyolex, so poročali o zvišanih jetrnih encimih (zvišanje transaminaz), ugotovljenih s krvnimi preiskavami, ki so lahko znak okvare jeter.
Missed doses
Izpuščeni odmerki
Lamotrigine levels may be elevated when it is co-administered with cannabidiol.
Pri sočasni uporabi s kanabidiolom je lahko raven lamotrigina povišana.
DROP SEIZURES PER 28 DAYS Percentage Reduction from Baselinea
KONVULZNI NAPADI V 28 DNEH
Amber glass bottle (type III) with a child-resistant and tamper-evident screw cap (polypropylene).
Steklenica jantarne barve (tipa III) z za otroke varno navojno zaporko (polipropilensko) z zaščito pred poseganjem v zdravilo.
Inhibition of P-gp mediated efflux by cannabidiol in the intestine cannot be ruled out.
Ni mogoče izključiti možnosti, da kanabidiol v črevesju zavira izločanje, ki ga povzroča P-gp.
p<0.0001c ≥ 50% REDUCTION IN DROP SEIZURES (RESPONDER ANALYSIS) Percentage of ≥ 50% Responders, p-valued GWPCARE3 Placebo
Odstotek ≥ 50 % odzivnih bolnikov, p-vrednostd GWPCARE2 Placebo
The adaptor could come off and cause choking if it is not fully inserted.
Če nastavek ni popolnoma vstavljen, se lahko sname in povzroči zadušitev.
Patients with sustained transaminase elevations of greater than 5 times the ULN should also have treatment discontinued.
Zdravljenje je treba prekiniti tudi pri bolnikih, ki imajo vrednosti transaminaz dolgotrajno zvišane nad 5-kratno ZMN.
You may get the following side effects with this medicine.
Pri jemanju tega zdravila se lahko pojavijo spodaj navedeni neželeni učinki.
Dose adjustment or discontinuation of valproate or dose adjustment of clobazam should be considered if transaminase elevations occur.
Če se pojavi zvišanje transaminaz, je treba razmisliti o prilagoditvi odmerka valproata ali o prekinitvi zdravljenja z njim, oziroma o prilagoditvi odmerka klobazama.
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).
Dodatna sekundarna merila izidov v podskupini bolnikov, ki so se sočasno zdravili s klobazamom Kanabidiol je bil povezan s povečanjem odstotka oseb, ki so imele v vsakem od preskušanj v obdobju zdravljenja 75-odstotno ali večje zmanjšanje pogostnosti konvulznih napadov (36 % bolnikov, ki so prejemali 10 mg/kg kanabidiola na dan, 25 % bolnikov za vsako skupino z odmerkom 20 mg/kg kanabidiola na dan, 10 % do 13 % prejemnikov placeba).
1 mg/kg twice daily (2 mg/kg/day)
1 mg/kg dvakrat na dan (2 mg/kg/dan)
Cannabidiol induces CYP1A2 and CYP2B6 mRNA expression at clinically relevant concentrations.
Kanabidiol pri klinično pomembnih koncentracijah izzove ekspresijo mRNA za encima CYP1A2 in CYP2B6.
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).
Dodatna sekundarna merila izidov v podskupini bolnikov, ki so se sočasno zdravili s klobazamom Kanabidiol je bil povezan s povečanjem odstotka oseb, ki so imele v vsakem od preskušanj med zdravljenjem vsaj 75-odstotno zmanjšanje pogostnosti epileptičnih napadov (11 % bolnikov, ki so prejemali 10 mg/kg kanabidiola na dan, 31 % do 36 % bolnikov, ki so prejemali 20 mg/ kg kanabidiola na dan, 3 % do 7 % prejemnikov placeba).
Contains refined sesame oil, ethanol and strawberry flavour components (including benzyl alcohol).
Vsebuje rafinirano sezamovo olje, etanol in sestavine arome jagode (vključno z benzil alkoholom).
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 Celokupni podatki so predstavljeni kot ocenjena mediana razlika in vrednost p iz Wilcoxonovega testa vsote rangov.
Hepatobiliary disorders
Hematološke nepravilnosti
5 mg/kg twice daily (10 mg/kg/day)
5 mg/kg dvakrat na dan (10 mg/kg/dan)
The elevations resolved after discontinuation of cannabidiol.
Po prekinitvi zdravljenja s kanabidiolom so se zvišane vrednosti popravile.
Cough
Kašelj
Placebo 20 mg/kg/day Difference or Percent Reduction Compared with Placebo (95% CI), p-valueb GWPCARE2
Razlika ali odstotek zmanjšanja v primerjavi s placebom (95-% IZ) p-vrednost b GWPCARE2 10 mg/kg/dan p = 0,0095
LIST OF EXCIPIENTS Contains refined sesame oil, ethanol and strawberry flavour components (including benzyl alcohol).
SEZNAM POMOŽNIH SNOVI Vsebuje rafinirano sezamovo olje, etanol in sestavine arome jagode (vključno z benzil alkoholom).
Management of overdose
Ukrepanje v primeru prevelikega odmerjanja
0.5 mg/kg twice daily (1 mg/kg/day)
0,5 mg/kg dvakrat na dan (1 mg/kg/dan)
No effects on cannabidiol or metabolite exposures were observed following administration of a single dose of cannabidiol 200 mg in subjects with mild hepatic impairment.
Po enkratnem 200-miligramskem odmerku kanabidiola pri preiskovancih z blago okvaro jeter niso opazili učinkov na izpostavljenost kanabidiolu ali presnovku.
Gastrointestinal disorders
peroralna raztopina
Dose response
Odziv na odmerek
How to store Epidyolex
Shranjevanje zdravila Epidyolex
Interaction resulting in an increase in exposure of the active metabolite 7-OH-CBD in HV* studies.
V študijah z zdravimi prostovoljci je interakcija povzročila povečano izpostavljenost aktivnemu presnovku 7-OH-CBD.a
a Data for the overall population are presented as median percent reduction from baseline.
IZ = 95-odstotni interval zaupanja a Podatki za celotno populacijo so predstavljeni kot mediana vrednost odstotka zmanjšanja glede na izhodišče.
Each ml of solution contains:
Pomožne snovi z znanim učinkom En ml raztopine vsebuje:
Dose reduction of the substrates may be necessary when cannabidiol is administered concomitantly with substrates of these UGTs.
Pri sočasnem dajanju kanabidiola in substratov teh encimov UGT bo morda treba zmanjšati odmerek substratov.
Additional secondary outcome measures in the subgroup of patients treated with concomitant clobazam
N Podskupina bolnikov s klobazamom
Very common Somnolencea Common
Somnolencaa
Placebo 10 mg/kg/day p=0.0332
10 mg/kg/dan p = 0,0332
Nervous system disorders
Okvara jetrnih celic
PHARMACEUTICAL FORM Oral solution
FARMACEVTSKA OBLIKA Peroralna raztopina
Placebo 20 mg/kg/day p=0.0784
GWPCARE1 Placebo 20 mg/kg/dan p = 0,0784
2.5 mg/kg twice daily (5 mg/kg/day)
2,5 mg/kg dvakrat na dan (5 mg/kg/dan)
Reduction in dose of clobazam should be considered if somnolence or sedation are experienced when clobazam is co-administered with cannabidiol.
Če se pri sočasnem dajanju klobazama in kanabidiola pojavi somnolenca ali sedacija, je treba razmisliti o zmanjšanju odmerka klobazama.
Hepatic impairment
Bolezni prebavil
In the case of one or more missed doses, the missed doses should not be compensated.
Izpuščenega(-ih) odmerka(-ov) se ne sme nadomeščati.
GWPCARE3 10 mg/kg/day p=0.0016
GWPCARE3 Placebo 10 mg/kg/dan p = 0,0030
In LGS and DS patients, the mean decrease in haemoglobin from baseline to end of treatment was −0.37 g/dL in cannabidiol-treated patients.
−0,37 g/dl pri bolnikih, zdravljenih s kanabidiolom.
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of oral solution contains 100 mg cannabidiol
NAVEDBA ENE ALI VEČ UČINKOVIN En ml peroralne raztopine vsebuje 100 mg kanabidiola.
Two 5 ml oral syringes with bottle adaptor
Dve 1-mililitrski brizgi za peroralno dajanje z nastavkoma za steklenico Dve 5-mililitrski brizgi za peroralno dajanje z nastavkoma za steklenico
Placebo 10 mg/kg/day 20 mg/kg/day
20 mg/kg/dan
Decreased weight
Zmanjšana telesna masa
Posology
Presnova
Common
Pogostnost
Maintenance Dose Maximum Recommended Dose
- Navodilo shranite.
1 week (7 days)
1 teden (7 dni)
All subsequent treatment visits (including reinitiation)
Vsi nadaljnji terapevtski obiski (vključno s ponovno uvedbo)
30th June, 2021
30. junij 2021
This medicine contains genetically modified organisms.
To zdravilo vsebuje genetsko spremenjene organizme.
Study 005/05
Študija 005/05
Your second injection will be given 3 weeks after the first injection.
Drugo injekcijo boste dobili 3 tedne po prvi injekciji.
HSV-1 seronegative patients
HSV-1 seronegativni bolniki
Study Month
Mesec študije
All patients
Vsi bolniki
Continue until the full dose is evenly and completely dispersed.
Nadaljujte, dokler ni celotni odmerek porazdeljen enakomerno in popolnoma.
Previous systemic treatment for melanoma was allowed but not required.
Predhodno sistemsko zdravljenje melanoma je bilo dovoljeno, ni pa bilo zahtevano.
• think you may be pregnant
• če menite, da bi lahko bili noseči,
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 December 2015
Datum prve odobritve: 16. december 2015
These symptoms generally resolve within the first 72 hours after treatment.
Ti simptomi po navadi izginejo v prvih 72 urah po zdravljenju.
Reproductive and development toxicity
Reproduktivna in razvojna toksičnost
Overall response rate (% CR, % PR)
Celokupni delež odziva (% CR, % PR)
- If you have any further questions, ask your healthcare professional (doctor or nurse).
- Če imate dodatna vprašanja, se posvetujte z zdravstvenim delavcem (zdravnikom ali medicinsko sestro).
After that, you will receive injections every 2 weeks for as long as you have the tumour(s).
Pozneje boste dobivali injekcije vsaka 2 tedna, dokler boste imeli tumor(je).
Kaplan-Meier Percent Alive
Kaplan-Meier - odstotek živih
• Wear gloves while changing your dressing.
• nosijo rokavice, medtem ko vam menjajo povoje.
QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description
KAKOVOSTNA IN KOLIČINSKA SESTAVA 2.1 Splošen opis
Number of Patients at Risk
Število bolnikov, izpostavljenih tveganju
No overall differences in safety or efficacy were observed between elderly (≥ 65 years old) and younger adult patients.
V celoti niso ugotovili razlik v varnosti in učinkovitosti med starejšimi bolniki (starimi ≥ 65 let) in mlajšimi odraslimi bolniki.
Patients experiencing a response at 12 months of treatment could continue treatment for up to an additional 6 months.
Bolniki, ki so v 12 mesecih dosegli odziv, so lahko zdravljenje nadaljevali do dodatnih 6 mesecev.
Keeping wounds clean and dressed can help prevent these types of infections.
Ohranjanje ran čistih in pokritih pomaga preprečiti takšne okužbe.
Patients with detectable DNA during treatment (n = 60)
Bolniki z zaznavno DNA med zdravljenjem (n = 60)
You should tell your healthcare professional if you notice any of these symptoms.
Zdravstvenemu delavcu morate povedati, če opazite katerega od teh simptomov.
The physician educational material should contain:
Izobraževalno gradivo za zdravnike mora vsebovati:
• Repeat these steps for other lesions that need to be injected.
• Ponovite te korake še na drugih spremembah, v katere morate injicirati.
Influenza-like symptoms
Gripi podobni simptomi
Twenty six (26) patients were exposed to Imlygic for at least one year.
Šestindvajset (26) bolnikov je bilo zdravilu Imlygic izpostavljenih vsaj eno leto.
The controlled distribution programme is aimed to manage the product supply chain to ensure that cold storage requirements are observed and to control the distribution of IMLYGIC to qualified centres and up to the patients.
Program nadzorovane distribucije je namenjen obvladovanju dobavne verige zdravila, da se zagotovi upoštevanje zahtev glede shranjevanja na hladnem, in se nadzoruje distribucijo zdravila IMLYGIC do kvalificiranih centrov in do bolnikov.
Imlygic is not recommended for children and adolescents since the effects of Imlygic in people younger than 18 years old are not known.
Zdravilo Imlygic ni priporočljivo za otroke in mladostnike, ker njegovi učinki pri osebah, mlajših od 18 let, niso znani.
Redirect the needle as many times as necessary while injecting the remainder of the dose of Imlygic.
Preusmerite iglo tolikokrat, kot je treba, in medtem injicirajte preostanek odmerka zdravila Imlygic.
Durable response rate Primary
Delež trajnega odziva Primarni
Exploratory subgroups
Eksplorativne podskupine
This leads to destruction of infected tumour cells.
To povzroči uničenje okuženih tumorskih celic.
The majority of patients, 98%, were caucasian.
Večina bolnikov (98 %) je bila belcev.
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOGA II A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Cellulitis and systemic bacterial infection have been reported.
Poročali so o celulitisu in sistemski bakterijski okužbi.
The median duration of exposure to Imlygic was 23 weeks (5.3 months).
Mediana trajanja izpostavljenosti zdravilu Imlygic je bila 23 tednov (5,3 meseca).
Keep used dressings and cleaning materials away from newborns.
Povoje in material za čiščenje shranjujte proč od novorojenčkov.
Due to the exploratory nature of the analysis and based on the current evidence, it has not been established that Imlygic is associated with an effect on overall survival.
Zaradi raziskovalnega značaja analiz in na podlagi trenutnih dokazov ni bilo ugotovljeno, da je zdravilo Imlygic povezano z učinkom na celokupno preživetje.
Efficacy data for Imlygic in the current second or later line treatment settings are limited.
Podatki o učinkovitosti zdravila Imlygic v trenutni drugi ali nadaljnjih linijah zdravljenja so omejeni.
These events were reported more frequently within the period of the first 6 treatments, particularly in patients who were HSV-1 negative at baseline.
O teh dogodkih so pogosteje poročali v obdobju prvih 6 zdravljenj, zlasti pri bolnikih, ki so bili izhodiščno HSV-1 negativni.
• Allergic reaction (hypersensitivity)
• alergijska reakcija (preobčutljivost).
• Provide specified safety information to patients and communicate to patients the importance for sharing this information with family and caregivers;
• Bolnikom je treba zagotoviti določene varnostne informacije in jim povedati, kako pomembno je, da te informacije delijo z družino in skrbniki.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100).
1 vial.
1 viala.
Imlygic 295 269 230 187 159 145 125 95 66 36 16 2 GM-CSF 141 124 100 83 63 52 46 36 27 15 5 0
Zdravilo Imlygic 295 269 230 187 159 145 125 95 66 36 16 2 GM-CSF 141 124 100 83 63 52 46 36 27 15 5
Overall, ninety eight per cent (98%) of these adverse reactions reported were mild or moderate in severity.
Skupno je bilo osemindevetdeset odstotkov (98 %) teh poročanih neželenih učinkov blagih ali zmernih.
This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
To ustreza 1,5 % največjega priporočenega dnevnega prehranskega vnosa soli za odraslega.
Pregnant women, neonates, and immunocompromised individuals should not be exposed to potentially contaminated materials.
Nosečnice, novorojenčki in imunokompromitirane osebe ne smejo biti izpostavljene potencialno kontaminiranim materialom.
4.1 months
4,1 mesecev
• Low red blood cell numbers (anaemia)
• majhno število rdečih krvnih celic (anemija),
Time to treatment failure (median)
Čas do neuspeha zdravljenja (mediana)
The most common grade 3 or higher adverse reaction was cellulitis (2.1%) (see section 4.4).
Najpogostejši neželeni učinek 3. ali višje stopnje je bil celulitis (2,1 %) (glejte poglavje 4.4).
Talimogene laherparepvec may have a minor influence on the ability to drive and use machines.
Talimogen laherparepvek ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
- if your healthcare professional has told you that you have a severely weakened immune system.
- če vam je zdravstveni delavec povedal, da imate močno oslabel imunski sistem.
In the pivotal clinical trial (study 005/05), events of cellulitis were recorded, some of them being considered as serious adverse events.
V ključnem kliničnem preskušanju (študija 005/05) so zabeležili pojave celulitisa, od teh so nekatere obravnavali kot resne neželene dogodke.
However, none lead to permanent discontinuation of Imlygic treatment.
Vendar noben ni vodil do trajnega prenehanja zdravljenja z zdravilom Imlygic.
Treatment with talimogene laherparepvec should be initiated and supervised by a qualified physician experienced in the treatment of cancer.
Zdravljenje s talimogenom laherparepvekom mora uvesti in nadzorovati usposobljen zdravnik, ki ima izkušnje na področju zdravljenja raka.
Talk to your healthcare professional about suitable methods of contraception.
Z zdravstvenim delavcem se posvetujte o primernih načinih kontracepcije.
The maximum dose of Imlygic that can be safely administered has not been determined.
Največji odmerek zdravila Imlygic, ki ga je mogoče varno uporabiti, ni ugotovljen.
Women of childbearing potential/contraception
Ženske v rodni dobi/kontracepcija
Pharmacokinetics in special populations
Farmakokinetika v posebnih populacijah
Not reached (Range: > 0.0 to > 16.8 months)
Ni dosežen (Razpon: > 0,0 do > 16,8 mesecev)
Proportion Alive
Delež živih
Imlygic also works by helping your immune system to recognise and destroy tumours throughout your body.
Zdravilo Imlygic poleg tega deluje tudi tako, da pomaga imunskemu sistemu prepoznati in uničiti tumorje po vsem telesu.
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Treba je upoštevati aditivni učinek sočasnega dajanja zdravil, ki vsebujejo sorbitol (ali fruktozo), in prehranskega vnosa sorbitola (ali fruktoze).
3.7 months
3,7 mesecev
90% of patients treated with Imlygic experienced influenza-like symptoms.
90 % bolnikov, zdravljenih z zdravilom Imlygic, je imelo gripi podobne simptome.
The safety and efficacy of Imlygic in paediatric patients has not been established.
Varnost in učinkovitost zdravila Imlygic pri pediatričnih bolnikih še nista bili dokazani.
The educational programme is aimed to inform about important risks associated with IMLYGIC:
Izobraževalno gradivo je namenjeno informiranju o pomembnih tveganjih, povezanih z zdravilom IMLYGIC: