FrancophonIA/ELRC3.0 huggingface dataset:
English: Relative to the pathology status of lymph node collection from a complete lymph node dissection, technetium Tc 99m tilmanocept correctly localised in sentinel lymph nodes predictive of harbouring metastatic tumour in 38 of 39 patients, for a false negative rate of 2.56%.
Slovenian: Glede na patološko stanje bezgavk, odvzetih s popolno disekcijo bezgavk, se je s tehnecijem Tc99m označen tilmanocept pravilno lokaliziral v varovalnih bezgavkah, napovednih kot povezanih z metastaskim tumorjem, pri 38 bolnikih od 39, pri čemer je bil delež lažno negativnih rezultatov 2,56 %.
English: Assay the syringe for technetium Tc 99m activity in a dose calibrator.
Slovenian: V umerjevalniku odmerka preverite aktivnost tehnecija Tc99m v injekcijski brizgi.
English: Estimated radiation absorbed dose for breast cancer, mGy/MBq Target organ
Slovenian: Ocena odmerka, absorbiranega iz zdravila Lymphoseek, pri bolnicah z rakom dojkea Ocena absorbiranega odmerka sevanja pri raku dojke, mGy/MBq Ciljni organ
English: Alternatively, vital blue dye localised in 63.50% of the excised lymph nodes detected by technetium Tc 99m tilmanocept (reverse concordance).
Slovenian: Nasprotno se je z vitalnim modrim barvilom lokaliziralo 63,50 % odstranjenih bezgavk, zaznanih s tilmanoceptom, označenim s tehnecijem Tc99m (reverzno ujemanje).
English: CLINICAL PARTICULARS
Slovenian: KLINIČNI PODATKI
English: Patients scheduled for surgery on the day of injection will receive 18.5 MBq technetium Tc 99m radiolabelled product.
Slovenian: Bolniki, pri katerih načrtujejo kirurški poseg isti dan, bodo prejeli zdravilo, radiološko označeno s tehnecijem Tc99m, z aktivnostjo 18,5 MBq.
English: Lot:
Slovenian: Serija:
English: In one Phase 3 clinical study in patients with intraoral or cutaneous squamous cell carcinoma, technetium Tc 99m tilmanocept localised sentinel lymph nodes in 97.59% of patients who underwent lymph node evaluation.
Slovenian: V eni klinični študiji 3. faze pri bolnikih z intraoralnim ali kožnim skvamoznim karcinomom je s tehnecijem Tc99m označeni tilmanocept lokaliziral varovalne bezgavke pri 97,59 % bolnikov, pri katerih so opravili oceno bezgavk.
English: In in vitro studies, technetium Tc 99m tilmanocept exhibited specific and tight binding to human CD206 receptors with a primary binding site affinity of Kd = 2.76 x x 10-11 M. In Phase 1 clinical studies,
Slovenian: V študijah in vitro so pokazali, da se s tehnecijem Tc99m označen tilmanocept specifično in močno veže na humane receptorje CD206, pri čemer je primarna afiniteta na mestu vezave Kd = 2,76 x 10-11 M. V kliničnih študijah 1. faze se je s specifično vezavo po 30 minutah približno 0,5 do 1,8 % odmerka nakopičilo v drenažnih bezgavkah.
English: Tilmanocept is a macromolecule consisting of multiple units of diethylenetriaminepentaacetic acid (DTPA) and mannose, each synthetically attached to a 10 kDa dextran backbone.
Slovenian: Tilmanocept je makromolekula, sestavljena iz več enot dietilentriaminpentaocetne kisline (diethylenetriaminepentaacetic acid - DTPA) in manoze, ki so sintetično pripete na glavno verigo iz dekstrana 10 kDa. Manoza deluje kot substrat za receptor, DTPA pa je kelator za označevanje s tehnecijem Tc99m.
English: Table 1.
Slovenian: Preglednica 1.
English: In Phase 3 clinical studies, technetium Tc 99m tilmanocept was detectable in sentinel lymph nodes within 10 minutes.
Slovenian: V kliničnih študijah 3. faze je bilo mogoče s tehnecijem Tc99m označen tilmanocept v varovalnih bezgavkah zaznati v 10 minutah.
English: Cardiac disorders
Slovenian: Srčne bolezni
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk
English: Without withdrawing the needle, remove an equal volume of headspace gas.
Slovenian: Iglo pustite v viali in izvlecite enako prostornino plina nad tekočino.
English: The 20 microgram dose peaked at 2.5 hours with a mean %ID/g of 0.0023%/g ± 0.0005%/g.
Slovenian: Pri odmerku 20 mikrogramov je bila ta vrednost največja po 2,5 ure, pri čemer je bila povprečna vrednost %ID/g 0,0023 %/g ± 0,0005 %/g.
English: For injection
Slovenian: POSTOPEK UPORABE za injiciranje
English: b. For radiolabelling, use sodium pertechnetate (Tc 99m) solution from a technetium Tc 99m generator within 8 hours of its elution.
Slovenian: b. Za radiooznačevanje v 8 urah po eluciji uporabite raztopino natrijevega pertehnetata (Tc99m) iz generatorja tehnecija Tc99m.
English: Posology
Slovenian: Škatla
English: The lymph nodes nearest the tumour are called ‘sentinel' lymph nodes.
Slovenian: Bezgavke, ki so najbližje tumorju, se imenujejo »varovalne« bezgavke.
English: In the Phase 1 study in melanoma patients, Lymphoseek at all three doses tested (20, 100, and 200 micrograms) cleared the injection site with elimination rate constants in the range of 0.227/h to 0.396/h, resulting in drug half-life at the injection site of 1.75 to 3.05 h).
Slovenian: V študiji 1. faze pri bolnikih z melanomom se je zdravilo Lymphoseek v vseh treh preizkušenih odmerkih (20, 100 in 200 mikrogramov) z mesta injiciranja izločilo s konstantami hitrosti izločanja od 0,227/h do 0,396/h, kar je povzročilo razpolovni čas na mestu injiciranja od 1,75 do 3,05 h. Večanje privzema s tehnecijem Tc99m označenega tilmanocepta v primarni varovalni bezgavki je bilo odvisno od odmerka:
English: Lymphoseek 50 micrograms kit for radiopharmaceutical preparation
Slovenian: IME ZDRAVILA Lymphoseek 50 mikrogramov komplet za pripravo radiofarmaka
English: Macrophages are present in high concentrations in lymph nodes.
Slovenian: Koncentracije makrofagov v bezgavkah so velike.
English: • headache
Slovenian: • glavobol,
English: • feeling sick (nausea) or dizzy
Slovenian: • slabost (navzea) ali omotica,
English: Count each half of the strip with a suitable radioactivity counting apparatus (dose calibrator or multichannel analyzer).
Slovenian: Listič odstranite iz komore, počakajte, da se posuši, in ga prerežite na pol. Vsako polovico lističa odčitajte z ustreznim aparatom za merjenje radioaktivnosti (umerjevalnikom odmerka ali večkanalnim analizatorjem).
English: What Lymphoseek contains
Slovenian: Kaj vsebuje zdravilo Lymphoseek
English: PHARMACOLOGICAL PROPERTIES
Slovenian: Farmakokinetične lastnosti
English: Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje
English: Assay the syringe(s) in a dose calibrator.
Slovenian: Injekcijsko(e) brizgo(e) preverite v umerjevalniku odmerka.
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije
English: When the sentinel lymph node is found, the surgeon removes it.
Slovenian: Ko kirurg odkrije varovalno bezgavko, jo odstrani.
English: Renal and hepatic impairment
Slovenian: Ledvična in jetrna okvara
English: Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Slovenian: Radiofarmaki se bodo shranjevali v skladu z nacionalnimi predpisi o radioaktivnih snoveh.
English: Sodium ascorbate (E301) Stannous chloride dihydrate (E512) Sodium hydroxide (E524) Hydrochloric acid, dilute (E507)
Slovenian: Seznam pomožnih snovi trehaloza dihidrat glicin (E 640) natrijev askorbat (E 301) kositrov klorid dihidrat (E 512) natrijev hidroksid (E 524) klorovodikova kislina, razredčena (E 507)
English: Total injection volume should be no greater than 1.0 mL and no less than 0.1 mL.
Slovenian: Posamezne prostornine injiciranja ne smejo preseči 0,5 ml in ne smejo biti manjše od 0,1 ml. Skupna prostornina injiciranja ne sme biti večja od 1,0 ml in ne manjša od 0,1 ml. Redčenje zdravila v prostornini, večji od 1,0 ml, bi lahko vplivalo na porazdelitev zdravila Lymphoseek in vivo.
English: Distribution
Slovenian: Odmerjanje
English: OTHER
Slovenian: SERIJ
English: Tabulated list of adverse reactions
Slovenian: Seznam neželenih učinkov v obliki preglednice
English: 6.5 Nature and contents of container
Slovenian: Vrsta ovojnine in vsebina
English: i. Assay the radiolabelled vial for total radioactivity using a dose calibrator.
Slovenian: i. V umerjevalniku odmerka preverite skupno radioaktivnost v radiooznačeni viali.
English: Before administration of Lymphoseek you should: Follow the instructions of your doctor or nuclear medicine doctor.
Slovenian: Upoštevajte navodila svojega osebnega zdravnika ali zdravnika nuklearne medicine.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lymphoseek 50 micrograms kit for radiopharmaceutical preparation tilmanocept
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Lymphoseek 50 mikrogramov komplet za pripravo radiofarmaka tilmanocept 2.
English: Sodium ascorbate (E301) Stannous chloride, dihydrate Sodium hydroxide (E524) Hydrochloric acid, dilute (E507)
Slovenian: Pomožne snovi: trehaloza, dihidrat glicin (E 640) natrijev askorbat (E 301) kositrov klorid, dihidrat natrijev hidroksid (E 524) klorovodikova kislina, razredčena (E 507)
English: The percent-of-injected dose reaching the primary sentinel node (%IDSN) was 0.05% ± 0.10%, 0.52% ± 0.38%, 0.21% ± 0.17% in the 4, 20, and 100 microgram Lymphoseek dose groups, respectively.
Slovenian: Odstotek injiciranega odmerka, ki je dosegel primarno varovalno bezgavko, (%IDSN) v skupinah z odmerkom zdravila Lymphoseek 4, 20 in 100 mikrogramov je bil 0,05 % ± 0,10 %, 0,52 % ± 0,38 % oziroma 0,21 % ± 0,17 %.
English: Discard unused product.
Slovenian: Neuporabljeno zdravilo zavrzite.
English: The 100 microgram dose peaked at 1 and 2 hours with a mean %ID/g of 0.0018%/g ± 0.001%/g at each timepoint.
Slovenian: Pri odmerku 100 mikrogramov je bila ta vrednost največja med 1 in 2 urama, pri čemer je bila povprečna vrednost %ID/g 0,0018 %/g ± 0,001 %/g.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT OTHER Contains an overfill.
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 6.
English: Skin and subcutaneous tissue disorders Uncommon: Skin irritation Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: Special populations Hepatic or renal impairment
Slovenian: Jetrna ali ledvična okvara
English: PHARMACEUTICAL FORM
Slovenian: NAČIN IZDAJANJA ZDRAVILA
English: Do not store above 25ºC Contains an overfill.
Slovenian: Shranjujte pri temperaturi do 25 C. Uporabite do roka uporabnosti na nalepki.
English: In Phase 3 clinical studies in melanoma patients mapped with both technetium Tc 99m tilmanocept and vital blue dye, technetium Tc 99m tilmanocept localised in 99.89% of patients with a mean 2.30 localised sentinel lymph nodes per patient by fixed effects meta-analyses.
Slovenian: V kliničnih študijah 3. faze pri bolnikih z melanomom, pri katerih so opravili mapiranje s tilmanoceptom, označenim s tehnecijem Tc99m, in vitalnim modrim barvilom, so v metaanalizi fiksnih učinkov pri tilmanoceptu, označenem s tehnecijem Tc99m, pri 99,89 % bolnikov odkrili povprečno 2,30 lokalizirane varovalne bezgavke na bolnika.
English: In Phase 3 clinical studies in breast cancer patients mapped with both technetium Tc 99m tilmanocept and vital blue dye, technetium Tc 99m tilmanocept localised in 99.91% of patients with a mean 2.08 localised sentinel lymph nodes per patient by fixed effects meta-analyses.
Slovenian: V kliničnih študijah 3. faze pri bolnicah z rakom dojke, pri katerih so opravili mapiranje s tilmanoceptom, označenim s tehnecijem Tc99m, in vitalnim modrim barvilom, so v metaanalizi fiksnih učinkov pri tilmanoceptu, označenem s tehnecijem Tc99m, pri 99,91 % bolnicah odkrili povprečno 2,08 lokalizirane varovalne bezgavke na bolnico.
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Slovenian: Radiofarmake je treba shranjevati v skladu z nacionalnimi predpisi o radioaktivnih snoveh.
English: Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Slovenian: Pri teh bolnikih obstaja možnost povečane izpostavljenosti sevanju, zato je treba skrbno pretehtati razmerje med tveganji in koristmi.
English: Careful consideration of the activity to be administered in these patients is required since an increased radiation exposure is possible.
Slovenian: Pri teh bolnikih obstaja možnost povečane izpostavljenosti sevanju, zato je treba skrbno pretehtati količino aktivnosti, ki jo bo prejel tak bolnik.
English: In the second Phase 1 study in breast cancer patients in which patients were injected with 20 micrograms Lymphoseek, the mean elimination rate constant of technetium Tc 99m tilmanocept was 0.299/h and the drug half-life at the injection site was 2.6 h. The %IDSN was 1.68% ± 1.22% in the 3 hour injection-to-surgery group and 1.81% ± 2.19% in the Lymphoseek 16 hour injection-to-surgery group.
Slovenian: razpolovni čas zdravila na mestu injiciranja pa je bil 2,6 h. Vrednost %IDSN v skupini s 3 urami med injiciranjem in kirurškim posegom je bila 1,68 % ± 1,22 %, v skupini s 16 urami med injiciranjem zdravila Lymphoseek in kirurškim posegom pa 1,81 % ± 2,19 %.
English: The surgeon uses the pictures taken to see where the sentinel lymph nodes are located.
Slovenian: Kirurg mesta bezgavk ugotovi na podlagi zajetih slik.
English: Uptake of technetium Tc 99m tilmanocept into the primary sentinel node increased dose-dependently: Lymphoseek injection at 20, 100, and 200 micrograms produced LSN values of 5.01 ± 8.02 pmol, 17.5 ± 13.7 pmol, and 58.2 ± 41.2 pmol of technetium Tc 99m tilmanocept, respectively.
Slovenian: injiciranje zdravila Lymphoseek v odmerkih 20, 100 in 200 mikrogramov je povzročilo ravni LSN s tehnecijem Tc 99m označenega tilmanocepta 5,01 ± 8,02 pmol, 17,5 ± 13,7 pmol oziroma 58,2 ± 41,2 pmol. Privzem %IDSN v primarni bezgavki je bil 0,50 % za odmerek zdravila Lymphoseek 20 mikrogramov, 0,35 % za odmerek 100 mikrogramov in 0,58 % za odmerek 200 mikrogramov.
English: 4.8 Undesirable effects
Slovenian: Neželeni učinek zdravila
English: Driving and using machines
Slovenian: Odmerjanje in način uporabe
English: Please refer to the SmPC [SmPC should be included in the box].
Slovenian: Glejte povzetek glavnih značilnosti zdravila (ki mora biti priložen škatli).
English: Effective dose (E) (females, mSv/MBq) a Calculated from data of 18 melanoma patients who received four intradermal injections of 20, 100,
Slovenian: a Izračunano na podlagi podatkov 18 bolnikov z melanomom, ki so prejeli štiri intradermalna injiciranja odmerkov zdravila Lymphoseek 20, 100 in 200 mikrogramov.
English: • flushing
Slovenian: • zardevanje,
English: 4.9 Overdose
Slovenian: Preveliko odmerjanje
English: How to store Lymphoseek
Slovenian: Shranjevanje zdravila Lymphoseek
English: A handheld gamma counter (represented by any handheld gamma detection probe) was used intraoperatively to identify sentinel lymph nodes localising technetium Tc 99m.
Slovenian: Za odkrivanje varovalnih bezgavk z lokaliziranim tehnecijem Tc99m so med kirurškim posegom uporabili ročni merilnik gama (ki ga predstavlja katera koli ročna sonda za zaznavanje žarkov gama).
English: Read the package leaflet before use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
English: Nervous system disorders
Slovenian: Bolezni živčevja
English: • blurred vision
Slovenian: • zamegljen vid,
English: Effective dose (E) (females, mSv/MBq) a Calculated from data of 18 breast cancer patients who received four peritumoural injections of 4,
Slovenian: a Izračunano na podlagi podatkov 18 bolnic z rakom dojke, ki so prejele štiri peritumorna injiciranja odmerkov zdravila Lymphoseek 4, 20 in 100 mikrogramov.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Slovenian: Shranjujte pri temperaturi do 25 C.
English: The 99mTc shows the surgeon where the sentinel lymph nodes are located.
Slovenian: 99mTc zdravniku kaže, kje so varovalne bezgavke.
English: You must inform the nuclear medicine doctor before the administration of Lymphoseek if there is a possibility you might be pregnant, if you have missed your period, or if you are breast-feeding.
Slovenian: Če obstaja možnost, da ste noseči, vam je izostala menstruacija ali dojite, o tem pred uporabo zdravila Lymphoseek obvestite zdravnika nuklearne medicine.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
English: Method of administration
Slovenian: Način uporabe
English: 5.1 Pharmacodynamic properties
Slovenian: Farmakodinamične lastnosti
English: MARKETING AUTHORISATION HOLDER
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Please ask your nuclear medicine doctor when you can resume breast-feeding.
Slovenian: O tem, kdaj lahko ponovno začnete dojiti, se posvetujte z zdravnikom nuklearne medicine.
English: Lymphoseek is given either the day before or on the day of your procedure.
Slovenian: Zdravilo Lymphoseek se injicira na dan kirurškega posega ali dan pred njim.
English: This is normal.
Slovenian: To je normalno.
English: There were three groups in this study.
Slovenian: V tej študiji so bile tri skupine.
English: Date of first authorisation: 26 July 2018
Slovenian: Datum prve odobritve: 26. julij 2018
English: OTHER SPECIAL WARNING, IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: (see section 4.4).
Slovenian: (glejte poglavje 4.4).
English: However, the occurrence was rare.
Slovenian: Vendar je bilo pojavljanje redko.
English: However, some may be serious and require treatment.
Slovenian: Nekateri pa so lahko resni in zahtevajo zdravljenje.
English: Fewer than half of at-risk subjects had an event.
Slovenian: Manj kot polovica rizičnih preiskovancev je imelo dogodek.
English: Age over 65 years
Slovenian: Starost nad 65 let
English: Alternative Storage:
Slovenian: Alternativno shranjevanje:
English: • Wash your hands well with soap and water.
Slovenian: • Roke si dobro umijte z milom in vodo.
English: The highest frequency seen among the various indications has been included.
Slovenian: Vključena je bila največja pogostnost med različnimi indikacijami.
English: Tell your doctor as soon as possible, if you notice any of the following:
Slovenian: Zdravniku čim prej povejte, če opazite kaj od naslednjega:
English: ACTIVATED.
Slovenian: AKTIVIRAN.
English: Some patients were treated for up to 120 months duration.
Slovenian: Nekatere bolnike so zdravili do 120 mesecev.
English: To help avoid possible infections and to ensure that you use the medicine correctly, it is important that you follow these instructions.
Slovenian: Da ne pride do morebitnih okužb in da zagotovite, da zdravilo pravilno uporabljate, je pomembno, da upoštevate ta navodila.
English: Some of those had a fatal outcome.
Slovenian: Nekateri so imeli smrtni izid.
English: Particular attention regarding the risk for infection should be paid when treating the elderly.
Slovenian: Posebna pozornost glede tveganja okužb je potrebna pri zdravljenju starejših.
English: • This means the medicine has been delivered.
Slovenian: • To pomeni, da je bilo zdravilo aplicirano.
English: Store in a refrigerator.
Slovenian: Shranjujte v hladilniku.
English: What do you need for your injection?
Slovenian: Kaj potrebujete za injiciranje?
English: This evaluation should include colonoscopy and biopsies per local recommendations.
Slovenian: Takšna ocena mora vključevati kolonoskopijo in biopsije v skladu z lokalnimi priporočili.
English: It is important that you:
Slovenian: Pomembno je, da:
English: UNITED STATES
Slovenian: ZDRUŽENE DRŽAVE AMERIKE
English: Clinical efficacy and safety
Slovenian: Klinična učinkovitost in varnost
English: • Listen for the 2nd click.
Slovenian: • Poslušajte, da boste zaslišali 2. klik.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Z namenom, da bi izboljšali sledljivost bioloških zdravil, morata biti ime in številka serije uporabljenega zdravila jasno zabeležena.
English: Summary of the safety profile
Slovenian: Povzetek varnostnega profila
English: Always take the outer carton of medicine with you, even if it is empty.
Slovenian: Vedno vzemite s seboj zunanjo ovojnino zdravila, tudi če je prazna.
English: • Look through the viewing window.
Slovenian: • Poglejte skozi opazovalno okence.
English: Tuberculosis can develop during therapy even if you have had preventative treatment for tuberculosis.
Slovenian: Tuberkuloza se lahko razvije med zdravljenjem, tudi če ste imeli preventivno zdravljenje za tuberkulozo.
English: All patients had a history of heavy smoking.
Slovenian: Vsi bolniki so imeli anamnezo hudega kajenja.
English: NE = not estimable.
Slovenian: NE = ni mogoče oceniti.
English: For single use only.
Slovenian: Samo za enkratno uporabo.
English: joints and other organ systems);
Slovenian: sklepov in drugih organskih sistemov);
English: See Vaccinations above.
Slovenian: Glejte podpoglavje Cepljenja zgoraj.
English: • if you have moderate or severe heart failure.
Slovenian: • če imate zmerno ali hudo srčno popuščanje.
English: This indicates the injection is almost complete.
Slovenian: To pomeni, da je injiciranje skoraj končano.
English: ASDAS inactive disease hs-CRPd,f,g
Slovenian: ASDAS neaktivna bolezen hs-CRPd,f,g
English: Available data suggest that adalimumab does not worsen or cause strictures.
Slovenian: Razpoložljivi podatki kažejo, da adalimumab ne poslabša in ne povzroči striktur.
English: Maintenance dose starting at week 4
Slovenian: Vzdrževalni odmerek z začetkom v 4. tednu
English: • if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na adalimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Most of the cases of tuberculosis occurred within the first eight months after initiation of therapy and may reflect recrudescence of latent disease.
Slovenian: Večina primerov tuberkuloze se je pojavila v prvih osmih mesecih po začetku zdravljenja in mogoče je, da gre za ponoven izbruh latentne bolezni.
English: Contact your doctor if the green indicator is not visible.
Slovenian: Obrnite se na zdravnika, če zeleni kazalnik ni viden.
English: • Insert the needle into your skin as shown.
Slovenian: • Iglo vstavite v kožo, kot je prikazano.
English: Quality of life and physical function
Slovenian: Kakovost življenja in telesna funkcija
English: primary analysis (ITT) placebo adalimumab
Slovenian: primarna analiza (ITT) placebo adalimumab
English: Not known (frequency cannot be estimated from available data)
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: Mean exposure in all adalimumab population was 762 days.
Slovenian: Povprečna izpostavljenost v celotni populaciji z adalimumabom je bila 762 dni.
English: • According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Slovenian: • Glede na študije v nosečnosti ni bilo večjega tveganja za defekte ob rojstvu, če je mati jemala adalimumab med nosečnostjo, v primerjavi z materami z enako boleznijo, ki adalimumaba niso jemale.
English: Most ALT elevations occurred with concomitant methotrexate use.
Slovenian: Večina zvišanj ALT se je pojavila pri sočasni uporabi metotreksata.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: ≥30% reduction in skin painb
Slovenian: ≥ 30 % zmanjšanje bolečine
English: Tuberculosis (TB)
Slovenian: Tuberkuloza (TB)
English: There may be a need for dose interruption, for instance before surgery or if a serious infection occurs.
Slovenian: Potrebna je lahko prekinitev uporabe, npr. pred operacijo ali če se pojavi resna okužba.