natgillin/translations-raw huggingface dataset:
Although it is not known if Imlygic could be transmitted through sexual contact, it is known that wildtype HSV-1 can be transmitted through sexual contact.
Ali se zdravilo Imlygic lahko prenaša s spolnim stikom, ni znano, znano pa je, da se s spolnim stikom lahko prenaša divji tip HSV-1.
• If storing thawed Imlygic in the original vial followed by a syringe: o the same temperature range should be maintained throughout the duration of storage until administration.
• Če shranjujete odtajano zdravilo Imlygic v originalni viali in nato v injekcijski brizgi: o med časom shranjevanja do uporabe je treba vzdrževati enako temperaturno območje.
If Imlygic is used during pregnancy, or if the patient becomes pregnant while taking Imlygic, the patient should be apprised of the potential hazards to the foetus and/or neonate.
Če je zdravilo Imlygic uporabljeno med nosečnostjo ali če bolnica zanosi med zdravljenjem z zdravilom Imlygic, jo je treba seznaniti z možno ogroženostjo ploda in/ali novorojenčka.
• Guide for healthcare professionals
• Vodnik za zdravstvene delavce
Other medicines and Imlygic
Druga zdravila in zdravilo Imlygic
§ American Joint Committee on Cancer (AJCC) staging 6th edition.
§ 6. izdaja klasifikacije stadijev Ameriškega združenja za rak (AJCC - American Joint Committee on Cancer).
Healthcare professionals who are immunocompromised or pregnant should not administer Imlygic and should not come into direct contact with the Imlygic injection site(s) or body fluids of treated patients (see sections 4.3 and 4.4).
Zdravstveni delavci, ki so imunokompromitirani, ali noseče zdravstvene delavke ne smejo dajati zdravila Imlygic in ne smejo priti v neposreden stik z mesti injiciranja zdravila Imlygic ali s telesnimi tekočinami zdravljenih bolnikov (glejte poglavji 4.3 in 4.4).
Log-rank p-value = 0.0511 Hazard Ratio [95% CI] = 0.79 [0.62, 1.00]
Log-rank p-vrednost = 0,0511 Razmerje ogroženosti [95 % IZ] = 0,79 [0,62, 1,00]
Plasmacytoma at injection site* Blood and lymphatic system disorders Very common Oedema peripheral Common
Občasni plazmacitom na mestu injiciranja* Bolezni krvi in limfatičnega sistema Zelo pogosti periferni edemi
1: GM-CSF (N = 86) Median (95% CI) 21.5 (17.4, 29.6) months 2: Talimogene Laherparepvec (N = 163) Median (95% CI) 41.1 (30.6, NE) months
1: GM-CSF (N = 86) Mediana (95 % IZ) 21,5 (17,4, 29,6) mesecev 2: Talimogen laherparepvek (N = 163) Mediana (95 % IZ) 41,1 (30,6, NO) mesecev
Talimogene laherparepvec is an oncolytic immunotherapy that is derived from HSV-1.
Talimogen laherparepvek je onkolitičen imunoterapevtik, izpeljan iz HSV-1.
Imlygic has not been studied in immunocompromised patients.
Zdravilo Imlygic pri imunokompromitiranih bolnikih ni raziskano.
At doses up to 4 x 108 PFU/kg or 107 PFU/dose (60-fold over the highest proposed clinical dose), single or repeated doses of talimogene laherparepvec administered by SC, IV, or intratumoural injection were well tolerated in immunocompetent mice, rats, and dogs.
V odmerkih do 4 x 108 PFU/kg ali 107 PFU/odmerek (60-krat več od največjega predlaganega kliničnega odmerka) v enkratnih ali ponavljajočih odmerkih talimogena laherparepveka, uporabljenega subkutano, intravensko ali v intratumorskih injekcijah so imunokompetentne miši, podgane in psi zdravilo dobro prenašali.
Nervous system disorders Very common Headache Common
Bolezni živčevja Zelo pogosti glavobol
Accidental exposure
Nenamerna izpostavljenost
This medicinal product contains 80 mg sorbitol (E420) per 4 mL dose.
To zdravilo vsebuje 80 mg sorbitola (E420) na 4 ml odmerek.
Because talimogene laherparepvec is designed to enter and replicate in the tumour tissue, there could be a risk of foetal exposure to talimogene laherparepvec from tumour tissue that has crossed the placenta.
Ker je talimogen laherparepvek zasnovan tako, da vstopi v tumorsko tkivo in se v njem razmnožuje, bi lahko obstajalo tveganje za izpostavljenost ploda talimogenu laherparepveku iz tumorskega tkiva, ki je prešlo skozi placento.
• 108 (100 million) PFU/mL - For all subsequent doses.
• 108 (100 milijonov) PFU/ml - za vse nadaljnje odmerke.
Name and address of the manufacturers responsible for batch release Amgen Europe B.V.
Ime in naslov izdelovalcev, odgovornih za sproščanje serij Amgen Europe B.V.
To submit the preliminary results from Study 20110266 (a phase 2, multicentre, randomised, open-label trial assessing the efficacy and safety of talimogene laherparepvec neoadjuvant treatment plus surgery vs surgery alone for resectable stage IIIB to IVM1a melanoma)
Predložiti preliminarne rezultate iz študije 20110266 (multicentrične, randomizirane, odprte študije faze II za oceno učinkovitosti in varnosti neoadjuvantnega zdravljenja s talimogenom laherparepvekom skupaj s kirurškim posegom v primerjavi s samim kirurškim posegom pri bolnikih z operabilnim melanomom stopenj IIIB do IVM1a).
Lethal systemic viral infection was observed in up to 20% of nude mice (primarily deficient in T lymphocyte function) and 100% of SCID mice (devoid of both T and B lymphocytes).
Sistemske virusne okužbe s smrtnim izidom so opažali pri do 20 % golih miši (primarno pomanjkanje delovanja limfocitov T) in pri 100 % miši SCID (ki so tako brez limfocitov T kot limfocitov B).
This medicine contains 80 mg sorbitol in each 4 mL dose.
To zdravilo vsebuje 80 mg sorbitola v vsakem 4 ml odmerku.
As with other wild-type HSV-1 infections, a latent pool of talimogene laherparepvec DNA may persist in neuronal cell bodies innervating the injection sites; therefore, the occurrence of latent infection with talimogene laherparepvec cannot be excluded.
Tako kot velja za druge okužbe z divjim tipom HSV-1, lahko ostane DNA talimogena laherparepveka latentno prisotna v telesih nevronskih celic, ki oživčujejo mesta injiciranj, zato pojava latentne okužbe s talimogenom laherparepvekom ni mogoče izključiti.
• After administration, change gloves prior to applying occlusive dressings to injected lesions.
• Po injiciranju zdravila zamenjajte rokavice, preden namestite okluzivni povoj na spremembe, v katere ste injicirali.
Treatment interval
Interval zdravljenja
• When removing the needle, withdraw it from the lesion slowly to avoid leakage or splash back of Imlygic at the insertion point.
• Ko odstranjujete iglo, jo iz spremembe izvlecite počasi, da boste preprečili iztekanje zdravila Imlygic ali da bi to brizgnilo iz mesta vboda.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Imlygic therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Imlygic, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
• Pregnant and lactating women
• Noseče in doječe ženske.
• First inject any new lesions (lesions that may have developed since previous treatment).
• Najprej injicirajte v morebitne nove spremembe (spremembe, ki so se morda pojavile od predhodnega zdravljenja).
It may contain white, visible, variously shaped, virus-containing particles.
V tekočini so lahko vidni beli delci različnih oblik, ki vsebujejo viruse.
Median [95% CI] 23.3 [19.5, 29.6] months Median [95% CI] 18.9 [16.0, 23.7] months
Mediana [95 % IZ] 23,3 [19,5, 29,6] mesecev Mediana [95 % IZ] 18,9 [16,0, 23,7] mesecev
• Dehydration
• dehidracija,
United States
Združene Države Amerike
• Trained HCPs to record batch number information in patient´s charts and on the patient´s alert card for all injections and to provide the batch number when reporting adverse drug reactions.
• Zdravstveni delavci morajo biti poučeni, da zabeležijo številko serije zdravila v bolnikovo dokumentacijo in na opozorilno kartico za bolnika za vse injekcije zdravila in da navedejo številko serije pri poročanju o neželenih učinkov zdravila.
• Patient information pack
• Paket informacij za bolnike
Imlygic is given in a healthcare facility under the supervision of a healthcare professional.
Zdravilo Imlygic boste dobili v zdravstveni ustanovi in pod nadzorstvom zdravstvenega delavca.
This leaflet was last revised in
Navodilo je bilo nazadnje revidirano dne {mesec LLLL}.
• Cancerous white blood cells at or near the injection site (plasmacytoma).
• rakave bele krvne celice na mestu injiciranja ali blizu njega (plazmacitom),
Herpetic infection in Imlygic-treated patients
Herpetična okužba pri bolnikih, zdravljenih z zdravilom Imlygic
Summary of results from exploratory subgroup analysis from Imlygic study 005/05
Preglednica 5: Povzetek rezultatov analize eksplorativnih podskupin iz študije 005/05 zdravila Imlygic
If signs or symptoms of herpetic infection develop, they should contact their healthcare professional.
Če se jim pojavijo znaki ali simptomi okužbe s herpesom, se morajo obrniti na svojega zdravstvenega delavca.
Signs and symptoms related to treatment with Imlygic may be the same as for herpes infections, and include pain, burning or tingling in a blister around the mouth or genitals, or on the fingers or ears, eye pain, light sensitivity, discharge from the eyes, or blurry vision, weakness in arms or legs, extreme drowsiness (feeling sleepy), and mental confusion.
Med zdravljenjem z zdravilom Imlygic se lahko pojavijo enaki znaki in simptomi kot med okužbami s herpesom in vključujejo bolečine, pekoč občutek ali mravljinčenje v mehurčku okrog ust ali spolovil, na prstih ali ušesih, bolečina v očeh, občutljivost za svetlobo, izcedek iz oči ali zamegljen vid, šibkost rok ali nog, izredna zaspanost in duševna zmedenost.
They will then help you decide whether to stop breast-feeding, or whether to stop taking Imlygic, taking into account the benefit of breast-feeding to the baby and the benefit of Imlygic to you.
Pomagali vam bodo pri odločitvi, ali naj nehate dojiti ali naj nehate uporabljati zdravilo Imlygic, tako da bodo upoštevali koristi dojenja za otroka in koristi zdravljenja z zdravilom Imlygic za vas.
HR: 0.79; (95% CI: 0.62, 1.00) p = 0.051
HR: 0,79; (95 % IZ: 0,62, 1,00) p = 0,051
8.2 months (95% CI: 6.5, 9.9)
8,2 mesecev (95 % IZ: 6,5, 9,9)
Injection site, oral mucosa, and anogenital area samples were collected during treatment and for up to 60 days after the end of treatment.
Vzorce mesta injiciranja in ustne sluznice ter anogenitalnega predela so odvzeli med zdravljenjem in do 60 dni po koncu zdravljenja.
Among patients with detectable talimogene laherparepvec DNA in the blood, urine, oral mucosa, and anogenital area, no samples had detectable talimogene laherparepvec DNA 30 days after the end of treatment.
Med bolniki z zaznavno DNA talimogena laherparepveka v krvi, urinu, ustni sluznici in anogenitalnem predelu 30 dni po koncu zdravljenja noben vzorec ni imel zaznavne DNA talimogena laherparepveka.
• Areas of skin without any colour (vitiligo), rash, inflamed skin (dermatitis)
• predeli kože brez barve (vitiligo), izpuščaj, vnetje kože (dermatitis),
Patients should be advised to use a latex condom during sexual contact to prevent possible transmission of Imlygic.
Bolnikom je treba naročiti, naj med spolnimi stiki uporabljajo kondome iz lateksa, da bi preprečili možen prenos zdravila Imlygic.
Immune-mediated events reported in the pivotal clinical study included a case of worsening psoriasis in a patient with a prior history of psoriasis, one case of pneumonitis in a patient with a prior history of autoimmune disease, one case of vasculitis, and two cases of glomerulonephritis of which one presented with acute renal failure.
Med imunsko pogojenimi učinki, poročanimi v ključni klinični študiji, so bili primer poslabšanja psoriaze pri bolniku z anamnezo psoriaze, en primer pnevmonitisa pri bolniku z anamnezo avtoimunske bolezni, en primer vaskulitisa in dva primera glomerulonefritisa, od katerih se je eden izrazil z akutno ledvično odpovedjo.
• Herpetic infection occurring throughout the entire body (disseminated herpetic infection) in immunocompromised individuals (those with any congenital or acquired cellular and/or humoral immune deficiency, i.e. HIV/AIDS, leukaemia, lymphoma, common variable immunodeficiency, or those who require high-dose steroids or other immunosuppressive agents)
• Herpetična okužba, ki se pojavi po celotnem telesu (diseminirana herpetična okužba) pri imunokompromitiranih posameznikih (tistih s kakršno koli kongenitalno ali pridobljeno celično in/ali humoralno imunsko pomanjkljivostjo, npr. HIV/AIDS-om, levkemijo, limfomom, sindromom variabilne imunske pomanjkljivosti, ali tistih, ki potrebujejo velike odmerke steroidov ali drugih imunosupresivnih zdravil).
• Disperse Imlygic evenly and completely within the lesion by pulling the needle back without exiting the lesion.
• Zdravilo Imlygic enakomerno in popolnoma porazdelite znotraj spremembe, tako da iglo potegnete nekoliko nazaj, ne da bi jo izvlekli iz spremembe.
Close contacts who are pregnant or immunocompromised should not change the patient's dressing or clean their injection site.
Osebe, ki so v tesnem stiku z bolnikom in so noseče ali imunokompromitirane, ne smejo menjati bolnikovih povojev ali čistiti njegovih mest injiciranja.
In clinical trials, one case of plasmacytoma at injection site was observed in a patient who was found to have multiple myeloma.
V kliničnih preskušanjih so opazili en primer plazmacitoma na mestu injiciranja pri bolniku, za katerega se je izkazalo, da ima diseminirani plazmacitom.
Imlygic may cause cancerous white blood cells to collect at or near the injection site (plasmacytoma).
Zdravilo Imlygic lahko povzroči kopičenje rakavih belih krvnih celic na mestu injiciranja ali ob njem (plazmacitom).
1.07, (95% CI: 0.75,
1,07, (95 % IZ: 0,75,
In the event of exposure to broken skin or needle stick, clean the affected area thoroughly with soap and water and/or disinfectant.
V primeru izpostavljenosti na poškodovani koži ali z vbodom igle predel temeljito očistite z milom in vodo in/ali razkužilom.
If you miss a dose of Imlygic
Če ste izpustili odmerek zdravila Imlygic
Kaplan-Meier plot -overall survival (ITT population)
Slika 4: Kaplan-Meier prikazi celokupnega preživetja (populacija z-namenom-zdravljenja)
• Tumour pain, infected tumour
• tumorska bolečina, okužen tumor,
These agents may interfere with the effectiveness of Imlygic if administered systemically or topically directly to the injection site.
Ta zdravila lahko ovirajo učinkovitost zdravila Imlygic, če so uporabljena sistemsko ali lokalno neposredno na mestu injiciranja.
All patients should be advised to use a latex condom during sexual contact to prevent possible transmission of Imlygic (see section 4.4).
Vsem bolnikom je treba naročiti, naj med spolnimi stiki uporabljajo kondome iz lateksa, da bi preprečili možen prenos zdravila Imlygic (glejte poglavje 4.4).
• Imlygic must not be refrozen once it has thawed.
• Ko je zdravilo Imlygic odtajano, se ga ne sme ponovno zamrzniti.
16.3% (n = 48) (95% CI: 12.1, 20.5)
16,3 % (n = 48) (95 % IZ: 12,1, 20,5)
Single-use vial permanently inserted into a clear copolyester plastic sleeve
Slika 6: Viala za enkratno uporabo, ki je trajno vstavljena v prozorni kopoliesterski plastični cilinder
Signs and symptoms of infection include pain, redness, warmth, swelling, discharge or a sore (ulcer), fever, and chills.
Med znaki in simptomi okužbe so bolečina, pordelost, toplota, oteklost, izcedek ali razjeda (ulkus), vročina in mrzlica.
Disseminated herpetic infection may also occur in immunocompromised patients (such as those with HIV/AIDS, leukaemia, lymphoma, common variable immunodeficiency, or who require chronic high-dose steroids or other immunosuppressive agents).
Diseminirana herpetična okužba se lahko pojavi tudi imunokompromitiranim bolnikom (npr. bolnikom s HIV/AIDS-om, levkemijo, limfomom, sindromom variabilne imunske pomanjkljivosti (CVID - common variable immunodeficiency) ali bolnikom, ki potrebujejo kronične velike odmerke steroidov ali drugih imunosupresivnih zdravil).
If the qPCR testing for talimogene laherparepvec DNA was positive, then a TCID50 assay was performed to measure viral infectivity.
Če je bilo preizkušanje qPCR za DNA talimogena laherparepveka pozitivno, so opravili preizkus TCID50 (TCID50 - 50% Tissue Culture Infectious Dose), da bi izmerili infektivnost virusa.
Dispose of all materials that have come in contact with Imlygic (e.g. vial, syringe, needle, any cotton or gauze) in accordance with local institutional procedures (see section 6.6).
Vse materiale, ki pridejo v stik z zdravilom Imlygic (npr. vialo, brizgo, iglo, morebitno vato ali gazo), odlagajte v skladu z lokalnimi postopki v ustanovi (glejte poglavje 6.6).
Use a new needle anytime the needle is completely removed from a lesion and each time a different lesion is injected.
Vsakič, ko iglo popolnoma izvlečete iz spremembe, in vsakič, ko injicirate v drugo spremembo, uporabite novo iglo.
Adverse reactions from clinical trials in patients with melanoma and post-marketing experience
Preglednica 3: Neželeni učinki iz kliničnih preskušanj pri bolnikih z melanomom in iz obdobja trženja zdravila
• Pain, redness, bleeding, swelling, inflammation, secretion, discharge, and warmth at the injection site
• bolečina, pordelost, krvavitve, oteklost, vnetje, izloček, izcedek in toplota na mestu injiciranja.
Imlygic GM-CSF
Zdravilo Imlygic GM-CSF
Acyclovir and other anti-viral agents may interfere with the effectiveness of Imlygic if administered systemically or topically directly to the injection site.
Aciklovir in druga protivirusna zdravila lahko ovirajo učinkovitost zdravila Imlygic, če so uporabljena sistemsko ali topikalno neposredno na mestu injiciranja.
• Wear protective gown or laboratory coat, safety glasses, or face shield and gloves while preparing or administering Imlygic.
• Med pripravo in dajanjem zdravila Imlygic nosite zaščitno obleko ali laboratorijsko haljo, zaščitna očala ali ščitnik za obraz in rokavice.
The proportion of samples and subjects with talimogene laherparepvec DNA was highest during cycle 2 of treatment for the blood, urine, injection site, and occlusive dressings; highest in cycle 1 of treatment for the oral mucosa; and highest in cycles 1 and 2 for the anogenital area.
Delež vzorcev in bolnikov z DNA talimogena laherparepveka je bil za kri, mesto injiciranja in okluzivne povoje največji v 2. ciklu zdravljenja, za ustno sluznico v 1. ciklu zdravljenja in za anogenitalni predel v 1. in 2. ciklu zdravljenja.
- The other ingredients are di-sodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, myo-inositol, sorbitol (E420), water for injections (see section 2).
- Druge sestavine so dinatrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat, natrijev klorid, mioinozitol, sorbitol (E420), voda za injekcije (glejte poglavje 2).
Common (may affect up to 1 in 10 people):
Pogosti (pojavijo se lahko pri največ 1 od 10 oseb):
What Imlygic looks like and contents of the pack
Izgled zdravila Imlygic in vsebina pakiranja
0.57, (95% CI: 0.40,
0,57, (95 % IZ: 0,40,
The following activities should be avoided: Sexual intercourse without a latex condom Kissing if either party has an open mouth sore Common usage of cutlery, crockery, and drinking vessels Common usage of injection needles, razorblades and toothbrushes; o Adequate waste disposal and decontamination, following the recommendations for disposal of biohazardous waste.
Izogibati se je treba sledečim aktivnostim: spolnim stikom brez uporabe kondoma iz lateksa, poljubljanju, če ima kateri od partnerjev odprto rano v ustih, skupni uporabi jedilnega pribora, posode in skodelic/kozarcev za pitje, skupni uporabi injekcijskih igel, britvic in zobnih ščetk, o Primerno odlaganje odpadkov in dekontaminacija v skladu s smernicami za odlaganje biološko nevarnih odpadkov.
Of the enrolled patients, 22% had stage IV M1c disease and 53% of patients had received prior therapy for melanoma such as chemotherapy and cytokine-based immunotherapy in addition to surgery, adjuvant therapy or radiation.
Moški so sestavljali 57 % populacije v študiji in 70 % bolnikov je imelo izhodiščno stanje zmogljivosti 0 po ECOG. Od zajetih bolnikov jih je 22 % imelo bolezen v stadiju IV M1c; 53 % bolnikov je predhodno že prejemalo zdravljenje za melanom, kot je kemoterapija in imunoterapija s citokini, poleg kirurškega posega, adjuvantnega zdravljenja ali obsevanja.
The biodistribution and shedding of intralesionally administered talimogene laherparepvec were investigated in a clinical study that measured talimogene laherparepvec DNA in blood, urine, injection site, exterior of the occlusive dressings, oral mucosa, anogenital area, and suspected herpetic lesions.
Biološko porazdelitev in izločanje intralezijsko uporabljenega talimogena laherparepveka so proučevali v klinični študiji, v kateri so merili raven DNA talimogena laherparepveka v krvi, v urinu, na mestu injiciranja, v zunanjosti okluzivnih povojev, v ustni sluznici, v anogenitalnem predelu in na spremembah, pri katerih obstaja sum na herpetični izvor.
Maximum total injection volume
Največja skupna injicirana količina
Adverse reactions were determined based on clinical trials in patients with melanoma treated with Imlygic compared to GM-CSF and post-marketing experience.
Neželene učinke so ugotovili v kliničnih preskušanjih pri bolnikih z melanomom, zdravljenih z zdravilom Imlygic, v primerjavi z GM-CSF, ter v obdobju trženja zdravila.
Traceability of Imlygic
Sledljivost zdravila Imlygic
Doses up to 4 mL at a concentration of 108 PFU/mL every 2 weeks have been administered in clinical trials with no evidence of dose limiting toxicity.
V kliničnih preskušanjih so uporabljali odmerke do 4 ml v koncentraciji 108 PFU/ml vsaka 2 tedna brez znakov toksičnih učinkov, ki bi omejevali odmerek.
This is a weakened form of herpes simplex virus type-1 (HSV-1), which is commonly called the cold sore virus.
To je oslabljena oblika virusa herpes simpleks tipa 1 (HSV-1), ki ga imenujejo tudi labialni herpes (herpes na ustnicah).
• Confusion, anxiety, depression, dizziness, difficulty sleeping (insomnia)
• zmedenost, tesnobnost, potrtost, omotica, težave s spanjem (nespečnost),
The following activities should be avoided: Sexual intercourse without a latex condom Kissing if either party has an open mouth sore Common usage of cutlery, crockery, and drinking vessels Common usage of injection needles, razorblades and toothbrushes;
Izogibati se je treba sledečim aktivnostim: spolnim stikom brez uporabe kondoma iz lateksa, poljubljanju, če ima kateri od partnerjev odprto rano v ustih, skupni uporabi jedilnega pribora, posode in skodelic/kozarcev za pitje, skupni uporabi injekcijskih igel, britvic in zobnih ščetk.
Di-sodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, myo-inositol, sorbitol (E420), water for injections.
Natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat, natrijev klorid, mioinozitol, sorbitol (E420), voda za injekcije.
• Clean the lesion and surrounding areas with an alcohol swab and let dry.
• Spremembo in njeno okolico očistite z alkoholnim zložencem in pustite, da se posuši.
• Before use, thaw frozen Imlygic vials at room temperature (20°C to 25°C) until Imlygic is liquid (approximately 30 minutes).
• Pred uporabo zamrznjene viale zdravila Imlygic odtajajte na sobni temperaturi (20°C do 25°C), dokler zdravilo Imlygic ni tekoče (približno 30 minut).
Cellulitis at the injection site
Celulitis na mestu injiciranja
Discard any thawed Imlygic in the vial or syringe stored longer than the specified times below.
Zavreči je treba odtajano zdravilo Imlygic v viali ali v injekcijski brizgi, ki je bilo shranjeno dlje od spodaj navedenih časov.
It is important for you to keep all your appointments to receive Imlygic.
Pomembno je, da pridete na vse preglede za injiciranje zdravila Imlygic.
Median 23.3 (95% CI: 19.5, 29.6) months
Mediana 23,3 (95 % IZ: 19,5, 29,6) mesecev
Musculoskeletal and connective tissue disorders Very common Myalgia, Arthralgia, Pain in extremity Common
Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti mialgija, artralgija, bolečine v okončini