FrancophonIA/ELRC3.0 huggingface dataset:
English: † Immune mediated events include: uncommon terms of vasculitis, pneumonitis, worsening psoriasis and glomerulonephritis.
Slovenian: † Imunsko pogojeni učinki vključujejo: občasne izraze vaskulitis, pnevmonitis, poslabšanje psoriaze in glomerulonefritis.
English: • Inject Imlygic intralesionally into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable or detectable by ultrasound guidance.
Slovenian: • Injicirajte zdravilo Imlygic intralezijsko v kožne, podkožne in/ali nodalne spremembe, ki so vidne, otipljive ali jih je mogoče odkriti ultrazvočno.
English: • Faster heart rate at rest (tachycardia)
Slovenian: • hitrejše bitje srca v mirovanju (tahikardija),
English: Autoimmune reactions
Slovenian: Avtoimunske reakcije
English: 26.4% (n = 78) (95% CI: 21.4%, 31.5%) (10.8% CR, 15.6% PR)
Slovenian: 26,4 % (n = 78) (95 % IZ: 21,4 %, 31,5 %) (10,8 % CR, 15,6 % PR)
English: o Information of the sign and symptoms of the risk of herpetic infection; o Information on IMLYGIC use in pregnancy; o Recommendation regarding the accidental transmission of IMLYGIC from patient to close contacts or HCPs: o Instructions to minimise the risk of exposure of blood and body fluids to close contacts for the duration of IMLYGIC treatment through 30 days after the last administration of IMLYGIC.
Slovenian: o Informacije o znakih in simptomih tveganja za herpetično okužbo; o Informacije o uporabi zdravila IMLYGIC med nosečnostjo; o Priporočilo glede nenamernega prenosa zdravila IMLYGIC z bolnika na osebe, ki so v tesnem stiku z bolnikom, ali zdravstvene delavce; o Navodila za osebe, ki so v tesnem stiku z bolnikom glede zmanjšanja tveganja za izpostavljenost krvi in telesnim tekočinam bolnika, za čas trajanja zdravljenja z zdravilom IMLYGIC in še 30 dni po zadnjem dajanju zdravila IMLYGIC.
English: 24 hours
Slovenian: 24 ur
English: Obstructive airway disorder
Slovenian: Obstruktivna motnja dihalnih poti
English: 5.7% (n = 8) (95% CI: 1.9%, 9.5%) (0.7% CR, 5% PR)
Slovenian: 5,7 % (n = 8) (95 % IZ: 1,9 %, 9,5 %) (0,7 % CR, 5 % PR)
English: In the event of an accidental exposure to Imlygic, exposed individuals should be advised to clean the affected area thoroughly with soap and water and/or a disinfectant.
Slovenian: V primeru nenamerne izpostavljenosti zdravilu Imlygic je treba izpostavljenim osebam naročiti, naj prizadeti predel temeljito očistijo z milom in vodo in/ali razkužilom.
English: • Side effects related to the immune system such as narrowing or blockage of blood vessels
Slovenian: • neželeni učinki, ki so povezani z imunskim sistemom, kot so zožitev ali zamašitev žil
English: Stage§ IVM1B/ IVM1C (Imlygic, n = 131;
Slovenian: Stadij§ IVM1B/ IVM1C (Imlygic, n = 131; GM-CSF, n = 55)
English: o Information on IMLYGIC use in pregnancy o Instructions how to handle possible adverse events including providing of batch number when reporting adverse drug reactions
Slovenian: o Navodila, kako obravnavati možne neželene učinke, vključno z navedbo številke serije zdravila pri poročanju neželenih učinkov zdravila.
English: • Keep injection sites covered with airtight and watertight dressings at all times.
Slovenian: • Mesta injiciranj naj bodo ves čas pokrita z neprodušnim in nepremočljivim povojem.
English: • Draw the desired amount of Imlygic from the vial into a syringe using aseptic technique.
Slovenian: • Z aseptičnim postopkom izvlecite želeno količino zdravila Imlygic iz viale v brizgo.
English: Hypersensitivity
Slovenian: Občasni preobčutljivost
English: Figure 2.
Slovenian: Slika 2:
English: o the maximum cumulative storage time (storage time in vial plus storage time in syringe) cannot exceed the durations in table 8.
Slovenian: o najdaljši kumulativni čas shranjevanja (čas shranjevanja v viali in čas shranjevanja v injekcijski brizgi) ne sme preseči časov, navedenih v preglednici 8.
English: to 26-gauge needle is recommended.
Slovenian: Priporočljive so igle od številke 22 do 26.
English: GRH0116v1
Slovenian: GRH0211SLv2
English: 2.9 months (95% CI: 2.8, 4.0) HR: 0.42; (95% CI: 0.32, 0.54)
Slovenian: 2,9 meseca (95 % IZ: 2,8, 4,0) HR: 0,42; (95 % IZ: 0,32, 0,54)
English: > 5 cm up to 4 mL
Slovenian: > 5 cm do 4 ml
English: • Swab the injection site and surrounding area with alcohol, and cover the injected lesion with an absorbent pad and dry occlusive dressing.
Slovenian: • Mesto injiciranja in okolico očistite z alkoholom, spremembo, v katero ste injicirali, pa pokrijte z vpojno blazinico in suhim okluzivnim povojem.
English: (1 million) PFU/mL
Slovenian: (1 milijon) PFU/ml
English: Figure 1.
Slovenian: Slika 1:
English: Up to 4 mL
Slovenian: Začetni do 4 ml
English: Confusional state, Anxiety, Depression, Dizziness, Insomnia
Slovenian: Pogosti stanje zmedenosti, anksioznost, depresija, omotica, nespečnost
English: Figure 3.
Slovenian: Slika 3:
English: Imlygic is provided in single use vials of 1 mL each in two different concentrations:
Slovenian: Zdravilo Imlygic je na voljo v 1 ml vialah za enkratno uporabo, ki vsebujejo eno od naštetih dveh koncentracij:
English: For patients with detectable DNA in injected lesions, no samples had detectable talimogene laherparepvec DNA 60 days after end of treatment.
Slovenian: Pri bolnikih z zaznavno DNA v spremembah, v katere je bilo injicirano zdravilo, 60 dni po koncu zdravljenja noben vzorec ni imel zaznavne DNA talimogena laherparepveka.
English: o the storage time in the syringe at ambient temperature up to 25°C cannot exceed 2 hours for 106 (1 million) PFU/mL and 4 hours for 108 (100 million) PFU/mL (see table 7).
Slovenian: o čas shranjevanja v injekcijski brizgi pri sobni temperaturi do 25°C ne sme preseči 2 ur za 106 (1 milijon) PFU/ml in 4 ur za 108 (100 milijonov) PFU/ml (glejte preglednico 7).
English: • Flu-like illness, fever (pyrexia), chills, fatigue, pain
Slovenian: • gripi podobna bolezen, zvišana telesna temperatura (pireksija), mrzlica, utrujenost, bolečina,
English: Urine
Slovenian: Urin
English: Plasmacytoma at injection site
Slovenian: Plazmacitom na mestu injiciranja
English: 4 hours
Slovenian: 4 ure
English: Patients with active brain metastases, bone metastases, extensive visceral disease, primary ocular or mucosal melanoma, evidence of immunosuppression, or receiving treatment with a systemic anti-herpetic agent were excluded from the study.
Slovenian: V študijo niso bili vključeni bolniki z aktivnimi zasevki v možganih, kostnimi zasevki, obširno visceralno boleznijo, primarnim očesnim ali sluzničnim melanomom, znaki imunosupresije ali bolniki, ki so prejemali sistemsko zdravljenje z antiherpetičnimi zdravili.
English: • 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.
Slovenian: • 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.
English: Imlygic is to be administered by intralesional injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable or detectable by ultrasound guidance.
Slovenian: Zdravilo Imlygic je treba injicirati intralezijsko v kožne, podkožne in/ali nodalne spremembe, ki so vidne, otipljive ali jih je mogoče odkriti ultrazvočno.
English: • Shortness of breath (dyspnoea), upper respiratory infection
Slovenian: • težko dihanje (dispneja), okužba zgornjih dihal,
English: Inform your healthcare professional if you have a history of blood cancer including multiple myeloma.
Slovenian: Obvestite zdravstvenega delavca, če ste kdaj imeli krvnega raka, vključno z diseminiranim plazmacitomom.
English: SPECIAL STORAGE CONDITIONS Store and transport frozen at -90° to -70°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte zamrznjeno pri temperaturi od -90 °C do -70 °C.
English: In case suspected herpetic lesions occur, patients, close contacts or healthcare providers have the option of follow-up testing by the Marketing Authorisation Holder for further characterisation of the infection.
Slovenian: Ob pojavu suma na herpetične spremembe imajo bolniki, osebe, ki so v tesnem stiku z bolnikom, ali zdravstveni delavci možnost kontrolnega testiranja za natančnejšo opredelitev okužbe pri imetniku dovoljenja za promet z zdravilom.
English: Imlygic is provided as a one ml preservative-free solution in a single-use vial (cyclic olefin polymer plastic resin) with stopper (chlorobutyl elastomer) and seal (aluminium) with flip-off cap (polypropylene) in two different presentations:
Slovenian: Zdravilo Imlygic je na voljo kot 1 ml raztopine brez konzervansov v viali za enkratno uporabo (ciklična olefinska polimerna plastična smola) z zamaškom (klorobutilni elastomer), zaporo (aluminij) in snemno zaporko (polipropilen) V dveh različnih pakiranjih:
English: - If you get any side effects, talk to your healthcare professional.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravstvenim delavcem.
English: Store and transport frozen at -90°C to -70°C.
Slovenian: Shranjujte in prevažajte zamrznjeno pri temperaturi od -90 °C do -70 °C.
English: o the maximum cumulative storage time (storage time in vial plus storage time in syringe) cannot exceed the durations in table 2.
Slovenian: o najdaljši kumulativni čas shranjevanja (čas shranjevanja v viali in čas shranjevanja v injekcijski brizgi) ne sme preseči časov, navedenih v preglednici 2.
English: • Eye infection caused by herpes (keratitis herpetic)
Slovenian: • okužba očesa s herpesom (herpetični keratitis),
English: o the storage time in the syringe at ambient temperature up to 25°C cannot exceed 2 hours for 106 (1 million) PFU/mL and 4 hours for 108 (100 million) PFU/mL (see table 1).
Slovenian: o čas shranjevanja v injekcijski brizgi pri sobni temperaturi do 25°C ne sme preseči 2 ur za 106 (1 milijon) PFU/ml in 4 ur za 108 (100 milijonov) PFU/ml (glejte preglednico 1).
English: The vial cap is colour coded: 106 PFU/mL is light green and 108 PFU/mL is royal blue.
Slovenian: Pokrovček viale je barvno kodiran: 106 PFU/ml je svetlo zelen in 108 PFU/ml je kraljevsko moder.
English: It is supplied as a 1 mL preservative free solution in a single -use vial (cyclic olefin polymer plastic resin) with stopper (chlorobutyl elastomer) and seal (aluminium) with flip-off cap (polypropylene).
Slovenian: Na voljo je kot 1 ml raztopine brez konzervansov v viali za enkratno uporabo (ciklična olefinska polimerna plastična smola) z zamaškom (klorobutilni elastomer), zaporo (aluminij) in snemno zaporko (polipropilen).
English: • Wound complication, secretion, bruising (contusion), pain after procedure
Slovenian: • zapleti na rani, izloček, podplutba (kontuzija), bolečine po postopku.
English: The vial cap is colour coded: 106 (1 million) PFU/mL is light green and 108 (100 million) PFU/mL is royal blue.
Slovenian: Pokrovček viale je barvno kodiran: 106 (1 milijon) PFU/ml je svetlo zelen in 108 (100 milijonov) PFU/ml je kraljevsko moder.
English: 2.1% (n = 3) (95% CI: 0.0, 4.5) Odds ratio 8.9; (95% CI: 2.7, 29.2) P < 0.0001
Slovenian: 2,1 % (n = 3) (95 % IZ: 0,0, 4,5) Razmerje obetov 8,9; (95 % IZ: 2,7, 29,2) p < 0,0001
English: • The patient information pack should contain: o Patient information leaflet o A patient/carer and close contacts guide
Slovenian: • Paket informacij za bolnike mora vsebovati: o Navodilo za uporabo.
English: In clinical studies, impaired healing at the injection site has been reported.
Slovenian: V kliničnih študijah so poročali o slabšem celjenju na mestu injiciranja.
English: (100 million) PFU/mL
Slovenian: (100 milijonov) PFU/ml
English: Deep vein thrombosis, Hypertension, Flushing Respiratory, thoracic and mediastinal disorders Very common Cough Common
Slovenian: Žilne bolezni Pogosti globoka venska tromboza, hipertenzija, zardevanje Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti kašelj
English: Treatment visit
Slovenian: Terapevtski obisk
English: However, available data for talimogene laherparepvec and wild-type HSV-1 do not indicate a carcinogenic risk in humans.
Slovenian: Kancerogenosti talimogena laherparepveka niso ocenili v dolgoročnih študijah na živalih ali pri človeku, vendar pa dostopni podatki za talimogen laherparepvek in divji tip HSV-1 ne kažejo kancerogenega tveganja pri človeku.
English: Single-use vial without a clear plastic sleeve
Slovenian: ALI Slika 7: Viala za enkratno uporabo brez prozornega plastičnega cilindra
English: Talimogene laherparepvec was injected into various xenograft tumours at doses up to 2 x 108 PFU/kg (30-fold over the highest proposed clinical dose) in immunodeficient mice (nude and SCID).
Slovenian: Talimogen laherparepvek so v odmerkih do 2 x 108 PFU/kg (30-krat več od največjega predlaganega kliničnega odmerka) injicirali v različne tumorske ksenotransplantate pri miših z imunsko pomanjkljivostjo (golih in SCID).
English: If herpetic lesions (blisters or sores) are suspected, patients or close contacts have the option of follow-up testing by the Marketing Authorisation Holder for further characterisation of the infection.
Slovenian: Ob sumu na herpetične spremembe (mehurje ali rane) imate bolniki ali osebe, s katerimi ste v tesnem stiku, možnost kontrolnega testiranja za natančnejšo opredelitev okužbe pri imetniku dovoljenja za promet z zdravilom.
English: It is recommended to keep injection sites covered with airtight and watertight dressings at all times, if possible.
Slovenian: Če je mogoče, je priporočljivo, da so mesta injiciranja ves čas pokrita z neprodušnim in nepremočljivim povojem.
English: • The injection site may be treated with a topical anaesthetic agent.
Slovenian: • Mesto injiciranja lahko omrtvičite z lokalnim anestetikom.
English: • Infection caused by bacteria (cellulitis), cold sores (oral herpes)
Slovenian: • bakterijska okužba (celulitis), labialni herpes (herpes na ustnicah),
English: Some people taking Imlygic have developed inflammation in the kidneys (glomerulonephritis), narrowing or blockage of blood vessels (vasculitis), swelling of the lungs (pneumonitis), worsening skin scaling (psoriasis), and areas of skin without any colour (vitiligo).
Slovenian: Pri nekaterih osebah, zdravljenih z zdravilom Imlygic, se je med zdravljenjem razvilo vnetje ledvic (glomerulonefritis), zožitev ali zapora žil (vaskulitis), vnetje pljuč (pnevmonitis), poslabšanje luščenja kože (luskavice) in predeli kože brez barve (vitiligo).
English: Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment with Imlygic (see section 4.6).
Slovenian: Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom Imlygic uporabljajo učinkovito kontracepcijsko zaščito za preprečitev nosečnosti (glejte poglavje 4.6).
English: Anogenital area
Slovenian: Anogenitalni predel
English: - The active substance is talimogene laherparepvec.
Slovenian: - Učinkovina je talimogen laherparepvek.
English: In clinical studies, herpetic infections (including cold sores and herpes keratitis) have been reported in patients treated with Imlygic.
Slovenian: V kliničnih študijah so pri bolnikih, zdravljenih z zdravilom Imlygic, poročali o herpetičnih okužbah (vključno z labialnim herpesom in herpetičnim keratitisom).
English: Wound complication, Wound secretion, Contusion, Procedural pain § Injection site reactions include: very common term of injection site pain, common terms of injection site erythema, injection site haemorrhage, injection site swelling, injection site reaction, injection site inflammation, secretion discharge, injection site discharge, uncommon term of injection site warmth.
Slovenian: Preiskave Pogosti zmanjšanje telesne mase Poškodbe, zastrupitve in zapleti postopkov Pogosti zapleti na rani, sekrecija iz rane, kontuzija, bolečina, povezana s postopkom § Učinki na mestu injiciranja vključujejo: zelo pogost izraz bolečina na mestu injiciranja, pogosti izrazi eritem na mestu injiciranja, krvavitev na mestu injiciranja, oteklina na mestu injiciranja, reakcija na mestu injiciranja, vnetje na mestu injiciranja, sekrecijski izcedek, izcedek na mestu injiciranja, občasen izraz toplota na mestu injiciranja.
English: Viral activity was measured in samples that were positive for talimogene laherparepvec DNA from the injection site, occlusive dressings, oral mucosa, anogenital area, and suspected herpetic lesions.
Slovenian: Virusno aktivnost so merili v vzorcih, ki so bili pozitivni na DNA talimogena laherparepveka, z mesta injiciranja, okluzivnih povojev, ustne sluznice, anogenitalnega predela in sprememb, pri katerih obstaja sum na herpetični izvor.
English: Censor indicated by vertical bar ׀ NE = not estimable
Slovenian: Krnjenje je označeno z navpičnimi črticami | NO = ni ocenljivo
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Common
Slovenian: Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi) Pogosti tumorska bolečina, okužba novotvorbe
English: • Accidental exposure of Healthcare Professionals (HCPs) to IMLYGIC
Slovenian: • Nenamerna izpostavljenost zdravstvenih delavcev zdravilu IMLYGIC.
English: Talimogene laherparepvec is cleared through general host-defence mechanisms (e.g. autophagy, adaptive immune responses).
Slovenian: Talimogen laherparepvek se odstrani s splošnimi obrambnimi mehanizmi gostitelja (npr. z avtofagijo, adaptivnim imunskim odzivom) in se razgradi po značilnih endogenih kataboličnih poteh beljakovin in DNA.
English: • Spread of IMLYGIC to close contacts or healthcare providers after direct contact with injected lesions or body fluids
Slovenian: • Prenos zdravila IMLYGIC na osebe, ki so v tesnem stiku z bolnikom, ali zdravstvene delavce po neposrednem stiku s spremembo, v katero je bilo injicirano zdravilo, in telesnim tekočinam zdravljenega bolnika.
English: Imlygic was administered by intralesional injection at an initial concentration of 106 (1 million) PFU/mL on day 1, followed by a concentration of 108 (100 million) PFU/mL on day 21 and every 2 weeks thereafter at a dose of up to 4 mL.
Slovenian: Zdravilo Imlygic so dajali z intralezijsko injekcijo z začetno koncentracijo 106 (1 milijon) PFU/ml 1. dan in nato s koncentracijo 108 (100 milijonov) PFU/ml 21. dan ter potem na 2 tedna v odmerku do 4 ml. GM-CSF so dajali subkutano v odmerku 125 µg/m2 vsak dan 14 dni, ki jim je sledilo 14-dnevno obdobje premora, v ponavljajočih se intervalih.
English: The active ingredient of Imlygic is talimogene laherparepvec.
Slovenian: Učinkovina v zdravilu Imlygic je talimogen laherparepvek.
English: Women who are able to become pregnant should use effective contraception to avoid pregnancy during treatment with Imlygic.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo, da preprečijo zanositev med zdravljenjem z zdravilom Imlygic.
English: Plasmacytoma has been reported in proximity to the injection site after administration of Imlygic.
Slovenian: Po uporabi zdravila Imlygic so poročali o plazmacitomu v bližini mesta injiciranja.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intralesional use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA intralezijska uporaba
English: Summary of results for the ITT population from Imlygic study 005/05 Study endpoint
Slovenian: Preglednica 4: Povzetek rezultatov za populacijo z-namenom-zdravljenja v študiji 005/05 zdravila Imlygic
English: Cellular uptake of talimogene laherparepvec occurs through HSV-1 receptors on tumours and nontumour cells following local injection into tumours.
Slovenian: Po lokalnem injiciranju v tumorje poteka celični privzem talimogena laherparepveka preko receptorjev HSV-1 na tumorskih in netumorskih celicah.
English: Follow the instructions below to prepare and administer Imlygic to patients:
Slovenian: Za pripravo in dajanje zdravila Imlygic bolnikom sledite spodnjim navodilom: Pred injiciranjem
English: Imlygic N = 295
Slovenian: Zdravilo Imlygic n = 295 GM-CSF n = 141
English: Overall survival
Slovenian: Celokupno preživetje Sekundarni
English: Cold sores or a more serious herpes infection may occur during or after treatment with Imlygic.
Slovenian: Med zdravljenjem z zdravilom Imlygic ali po njem se lahko pojavijo herpesi na ustnicah ali resnejše okužbe s herpesom.
English: GRH0149v1
Slovenian: GRH0275SLv1
English: (vasculitis), inflammation of the lungs (pneumonitis), worsening scaling of the skin (worsening psoriasis), and inflammation of kidneys (glomerulonephritis)
Slovenian: (vaskulitis), vnetje pljuč (pneumonitis), poslabšanje luščenja kože (poslabšanje luskavice),
English: Obstructive airway disorder has been reported following Imlygic treatment.
Slovenian: Po zdravljenju z zdravilom Imlygic so poročali o obstruktivni motnji dihalnih poti.
English: Thawed Imlygic may be stored prior to administration (see section 6.3).
Slovenian: Odtajano zdravilo Imlygic lahko shranite do uporabe (glejte poglavje 6.3).
English: Each vial contains 1 extractable mL of solution at a nominal concentration of 1 x 106 (1 million) plaque forming units (PFU)/mL or 1 x 108 (100 million) PFU/mL.
Slovenian: Iz ene viale je mogoče izvleči 1 mililiter raztopine z nominalno koncentracijo 1 x 106 (1 milijon) plakotvornih enot (PFU)/ml ali 1 x 108 (100 milijonov) PFU/ml.
English: HIV/AIDS, blood or bone marrow cancer, or if you are taking steroids or other medicines that suppress your immune system.
Slovenian: Obvestite zdravstvenega delavca, če imate ali ste kdaj imeli oslabljen imunski sistem, če imate HIV/AIDS, krvnega raka ali raka kostnega mozga, ali če jemljete steroide ali druga zdravila, ki zavirajo imunski sistem.
English: If your close contacts are accidentally exposed to Imlygic, they should clean the affected area on their body with soap and water and/or a disinfectant.
Slovenian: Če osebe, s katerimi ste v tesnem stiku, po nesreči pridejo v stik z zdravilom Imlygic, morajo prizadeti predel telesa očistiti z milom in vodo in/ali razkužilom.
English: The initial recommended dose is up to 4 mL of Imlygic at a concentration of 106 (1 million) PFU/mL.
Slovenian: Začetni priporočeni odmerek je do 4 ml zdravila Imlygic v koncentraciji 106 (1 milijon) PFU/ml.
English: Dyspnoea, Oropharyngeal pain, Upper respiratory tract infection
Slovenian: Pogosti dispneja, orofaringealna bolečina, okužba zgornjih dihal
English: ≤ 0.5 cm up to 0.1 mL
Slovenian: ≤ 0,5 cm do 0,1 ml
English: Selection of Imlygic injection volume based on lesion size
Slovenian: Preglednica 2: Izbira količine zdravila Imlygic za injiciranje glede na velikost spremembe
English: Intralesional use
Slovenian: Način uporabe
English: Exterior of the occlusive dressing Oral mucosa
Slovenian: Mesto injiciranja Zunanjost okluzivnega povoja Ustna sluznica
English: Cellulitis*, Oral herpes
Slovenian: Infekcijske in parazitske bolezni Pogosti celulitis*, oralni herpes
English: • Muscle pain (myalgia), painful/swollen joints (arthralgia), limb pain
Slovenian: • mišične bolečine (mialgija), boleči/otekli sklepi (artralgija), bolečine v okončini,
English: • Incision site infection
Slovenian: • okužba na mestu vboda,
English: If you get any side effects, talk to your healthcare professional.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravstvenim delavcem.
English: Infection caused by bacteria (cellulitis) at the injection site has been commonly seen in patients receiving Imlygic.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Imlygic, so pogosto opažali bakterijsko okužbo (celulitis) na mestu injiciranja.
English: • Using a single insertion point, inject Imlygic along multiple tracks as far as the radial reach of the needle allows within the lesion to achieve even and complete dispersion.
Slovenian: kolikor daleč dovoljuje radialni doseg igle znotraj spremembe, da boste dosegli enakomerno in popolno disperzijo.
English: Occlusive dressings samples were collected during treatment.
Slovenian: Med zdravljenjem so odvzeli vzorce okluzivnih povojev.
English: Multiple insertion points may be used if a lesion is larger than the radial reach of the needle.
Slovenian: Če je sprememba večja od radialnega dosega igle, lahko uporabite več mest vboda.
English: > 2.5 cm to 5 cm up to 2 mL
Slovenian: > 2,5 cm do 5 cm do 2 ml