natgillin/translations-raw huggingface dataset:
b. CRh*was defined as M1 marrow (≤ 5% of blasts in the bone marrow), no evidence of circulating blasts or extramedullary disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre) and no relapse within 28 days.
b. CRh* je bila opredeljena kot kostni mozeg M1 (≤ 5 % blastov v kostnem mozgu), brez znakov blastov v obtoku ali ekstramedularne bolezni, ter delno okrevanje periferne krvne slike (trombociti > 50.000/mikroliter in ANC > 500/mikroliter) ter brez relapsa v roku 28 dni.
Patients with Philadelphia chromosome negative relapsed or refractory B-precursor ALL with ECOG performance status at baseline of 2 experienced a higher incidence of serious infections compared to patients with ECOG performance status of < 2.
Incidenca resnih okužb je bila pri bolnikih z recidivno ali refraktarno ALL predhodniških celic B z negativnim Philadelphia kromosomom z izhodiščnim stanjem zmogljivosti 2 po ECOG večja kot pri bolnikih s stanjem zmogljivosti < 2 po ECOG. Za informacije o kliničnem obvladovanju okužb glejte poglavje 4.4.
POWDER VIAL
VIALA S PRAŠKOM
Capillary leak syndrome was observed in 1 patient in the phase II clinical study in adult patients with relapsed or refractory B-precursor ALL and in 1 patient in the phase 2 clinical study in adult patients with MRD positive B-precursor ALL.
faze pri odraslih bolnikih z recidivno ali refraktarno ALL predhodniških celic B in pri 1 bolniku v klinični študiji II.
- The other ingredients in the powder are citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80, and sodium hydroxide.
- Druge sestavine v prašku so citronska kislina monohidrat (E330), trehaloza dihidrat, lizinijev klorid, polisorbat 80 in natrijev hidroksid.
Efficacy results in patients ≥ 18 years of age with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL)
Rezultati učinkovitosti pri bolnikih, starih ≥ 18 let, ki so imeli recidivno ali refraktarno akutno limfoblastno levkemijo (ALL) predhodniških celic B z negativnim Philadelphia kromosomom n (%) n = 189
Sodium chloride 9 mg/mL (0.9%) solution for injection (starting volume)
Natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje (začetni volumen)
- Do not freeze.
- Ne zamrzujte.
Visually inspect the reconstituted solution for particulate matter and discolouration during reconstitution and prior to infusion.
Med rekonstitucijo in pred infundiranjem preglejte rekonstituirano raztopino glede delcev in spremembe barve.
BLINCYTO 271
zdravilo BLINCYTO 271 Standardna kemoterapija
In BLINCYTO-treated patients in the randomised phase III clinical study (N = 267) and the single arm phase II clinical study (N = 189), serious CRS reactions were reported in 2.4% of patients with a median time to onset of 2 days.
faze z eno samo skupino (N = 189), so pri 2,4 % bolnikov poročali o resnih reakcijah sindroma sproščanja citokinov z mediana časom do njihovega pojava 2 dni.
There were no effects on male or female reproductive organs in toxicity studies with the murine surrogate.
V študijah toksičnosti z mišjim nadomestkom niso ugotovili učinkov na reproduktivne organe samcev ali samic.
(thrombocytopenia), decreased levels of certain white blood cells (leukopenia)
znižano raven nekaterih belih krvnih celic (levkopenijo)
• fever, swelling, chills, decreased or increased blood pressure and fluid in the lungs, which may become severe (cytokine release syndrome)
• zvišana telesna temperatura, oteklost, mrzlica, zvišan ali znižan krvni tlak in tekočina v pljučih, ki lahko postanejo hudi (sindrom sproščanja citokinov)
Diarrhoea Vomiting Constipation Abdominal pain
Žilne bolezni hipotenzija hipertenzija vročinski oblivi sindrom povečane prepustnosti kapilar
Haemophagocytic histiocytosis/macrophage activation syndrome (MAS) has been uncommonly reported in the setting of CRS.
Občasno so v okviru sindroma sproščanja citokinov poročali o sindromu hemofagocitne histiocitoze/aktivacije makrofagov.
Efficacy results in patients ≥ 18 years of age with Philadelphia chromosome negative relapsed or refractory B-cell precursor ALL
Rezultati učinkovitosti pri bolnikih, starih ≥ 18 let, ki so imeli recidivno ali refraktarno ALL predhodniških celic B z negativnim Philadelphia kromosomom
Citric acid monohydrate (E330) Trehalose dihydrate Lysine hydrochloride Polysorbate 80
Prašek citronska kislina monohidrat (E330) trehaloza dihidrat lizinijev klorid polisorbat 80 natrijev hidroksid (za prilagoditev pH)
Cognitive disorder Memory impairment Dizziness
Psihiatrične motnje a nespečnost stanje zmedenosti dezorientiranost
Management of infections may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Obvladovanje okužb lahko zahteva začasno prekinitev ali trajno prenehanje uporabe zdravila BLINCYTO (glejte poglavje 4.2).
Cardiac disorders
Srčne bolezni tahikardija
Leukopenia includes leukopenia and white blood cell count decreased.
4 Levkopenija obsega levkopenijo in zmanjšanje števila belih krvnih celic.
Grade 3 Interrupt BLINCYTO until resolved, then restart BLINCYTO at 9 mcg/day.
3. stopnja Prekinite uporabo zdravila BLINCYTO, dokler učinek ne mine, nato začnite zdravilo znova uporabljati v odmerku 9 µg/dan.
Interrupt BLINCYTO until resolved, then restart BLINCYTO at 5 mcg/m2/day.
Prekinite uporabo zdravila BLINCYTO, dokler učinek ne mine, nato začnite zdravilo znova uporabljati v odmerku 5 µg/m2/dan.
Interrupt BLINCYTO until no more than grade 1 (mild), then restart BLINCYTO at 5 mcg/m2/day.
Prekinite uporabo zdravila BLINCYTO, dokler učinek ni največ 1. stopnje (blag), nato začnite zdravilo znova uporabljati v odmerku 5 µg/m2/dan.
(%) [95% CI] CRh*, n1/n2d (%) [95% CI] Median relapse e-free survival (RFS)
(%) [95 % IZ] CRh*, n1/n2
Management of these events may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Obvladovanje teh dogodkov lahko zahteva začasno prekinitev ali trajno prenehanje uporabe zdravila BLINCYTO (glejte poglavje 4.2).
Store at 2°C - 8°C if not used immediately.
Če zdravilo ni uporabljeno takoj, shranjujte pri temperaturi od 2 °C - 8 °C.
Based on pharmacokinetic analyses, no effect of baseline liver function on blinatumomab exposure is expected and adjustment of the initial dose is not necessary (see section 5.2).
Na podlagi farmakokinetičnih analiz ni pričakovati, da bi izhodiščno delovanje jeter vplivalo na izpostavljenost blinatumomabu.
Somnolence Hypoaesthesia Cranial nerve disorder b
Bolezni živčevja a glavobol tremor encefalopatija afazija parestezije konvulzije kognitivna motnja okvara spomina omotica somnolenca hipestezija motnja v kranialnem živčevju b ataksija motnja govora
One case of fatal encephalopathy has been reported in an earlier phase II clinical single-arm study.
Sindrom povečane prepustnosti kapilar so opazili pri 1 bolniku v klinični študiji II.
c. CRi (complete remission with incomplete haematologic recovery) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and incomplete recovery of peripheral blood counts (platelets > 100,000/microlitre or ANC > 1,000/microlitre).
c CRi (popolna remisija z nepopolnim hematološkim okrevanjem) je bila opredeljena kot ≤ 5 % blastov v kostnem mozgu, brez znakov bolezni in nepopolno okrevanje periferne krvne slike (trombociti > 100.000/mikroliter in absolutno število nevtrofilcev > 1.000/mikroliter).
a. CR was defined as M1 marrow (≤ 5% of blasts in the bone marrow), no evidence of circulating blasts or extramedullary disease, and full recovery of peripheral blood counts (platelets > 100,000/microlitre and absolute neutrophil counts [ANC] > 1,000/microlitre) and no relapse within 28 days.
a CR je bila opredeljena kot kostni mozeg M1 (≤ 5 % blastov v kostnem mozgu), brez znakov blastov v obtoku ali ekstramedularne bolezni, ter popolno okrevanje periferne krvne slike (trombociti > 100.000/mikroliter in absolutno število nevtrofilcev [ANC] > 1.000/mikroliter) ter brez relapsa v roku 28 dni.
Management of pancreatitis may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Obravnava pankreatitisa lahko zahteva začasno prekinitev ali trajno prenehanje uporabe zdravila BLINCYTO (glejte poglavje 4.2).
CRh* (complete remission with partial haematologic recovery) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre).
b CRh* (popolna remisija z delnim hematološkim okrevanjem) je bila opredeljena kot ≤ 5 % blastov v kostnem mozgu, brez znakov bolezni in delno okrevanje periferne krvne slike (trombociti > 50.000/mikroliter in absolutno število nevtrofilcev > 500/mikroliter).
For patients weighing greater than or equal to 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag
Za bolnike s telesno maso 45 kg ali več: volumni natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje, raztopine (stabilizatorja) in rekonstituiranega zdravila BLINCYTO, ki jih je treba dodati v infuzijsko vrečko
Overdoses resulted in adverse reactions which were consistent with the reactions observed at the recommended therapeutic dose and included fever, tremors, and headache.
Prevelika odmerjanja so povzročila neželene učinke, ki so se skladali z učinki, opaženimi med uporabo priporočenega terapevtskega odmerka.
Discontinue BLINCYTO permanently if more than one convulsion occurs.
Če se pojavi več kot en napad konvulzij, trajno prenehajte uporabljati zdravilo BLINCYTO.
Solution (stabiliser): citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injections.
Raztopina (stabilizator): citronska kislina monohidrat (E330), lizinijev klorid, polisorbat 80, natrijev hidroksid in voda za injekcije.
How to store BLINCYTO
Shranjevanje zdravila BLINCYTO
Neutropenia and febrile neutropenia, including life-threatening cases, have been observed in patients receiving BLINCYTO.
Pri bolnikih, ki so dobivali zdravilo BLINCYTO, so opažali nevtropenijo in febrilno nevtropenijo, tudi smrtno nevarne primere.
BLINCYTO has been evaluated in paediatric patients with relapsed or refractory B-precursor ALL in a phase I/II dose escalation/evaluation study, in which 70 paediatric patients, aged 7 months to 17 years, were treated with the recommended dosage regimen.
faze, pri kateri so zdravili 70 pediatričnih bolnikov starih od 7 mesecev do 17 let po priporočeni shemi odmerjanja.
Prednisone 100 mg intravenously or equivalent (e.g. dexamethasone 16 mg) should be administered 1 hour prior to initiation of each cycle of BLINCYTO therapy.
Priporočila za premedikacijo in dodatna zdravila Eno uro pred začetkom vsakega ciklusa zdravljenja z zdravilom BLINCYTO mora bolnik dobiti 100 mg prednizona intravensko ali drugo enakovredno zdravilo (npr. 16 mg deksametazona).
3 Thrombocytopenia includes platelet count decreased and thrombocytopenia.
Trombocitopenija obsega zmanjšanje števila trombocitov in trombocitopenijo.
- The solution (stabiliser) contains citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injections.
- Raztopina (stabilizator) vsebuje citronsko kislino monohidrat (E330), lizinijev klorid, polisorbat 80, natrijev hidroksid in vodo za injekcije.
Blast free hypoplastic or aplastic bone marrow Partial remission
Hipoplastičen ali aplastičen kostni mozeg brez blastov
Neutropenia Thrombocytopenia Leukopenia
Rekonstituirana raztopina
2.5 mL/hour
2,5 ml/uro
For patients weighing less than 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag for 5 mcg/m2/day dose
Za bolnike, ki tehtajo manj kot 45 kg: volumni natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje, raztopina (stabilizator) in rekonstituirano zdravilo BLINCYTO, ki jih je treba dodati infuzijski vrečki za odmerek 5 µg/m2/dan
• complications occurring after cancer treatment leading to increased blood levels of potassium,
• zapleti, ki se pojavijo po zdravljenju raka in povzročijo zvišano koncentracija kalija, sečne kisline in fosfata v krvi ter znižano koncentracijo kalcija v krvi (sindrom lize tumorja)
Yes No
Nihče od
CR was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/microlitre and absolute neutrophil counts [ANC] > 1,000/microlitre).
CR je bila opredeljena kot ≤ 5 % blastov v kostnem mozgu, brez znakov bolezni in popolno okrevanje periferne krvne slike (trombociti > 100.000/mikroliter in absolutno število nevtrofilcev > 1.000/mikroliter).
For patients weighing less than 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag for 15 mcg/m2/day dose
Za bolnike, ki tehtajo manj kot 45 kg: volumni natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje, raztopine (stabilizatorja) in rekonstituiranega zdravila BLINCYTO, ki jih je treba dodati v infuzijsko vrečko za odmerek 15 µg/m2/dan
HR (BLINCYTO/SOC Chemo) (95% CI) p-value (2-sided)
Mediano celokupno preživetje, meseci Razmerje ogroženosti (zdravilo BLINCYTO/standardna kemoterapija) (95 % IZ) p-vrednost (2-stranska)
Tumour lysis syndrome (TLS), which may be life-threatening or fatal (grade ≥ 4) has been observed in patients receiving BLINCYTO.
Med uporabo zdravila BLINCYTO so opažali sindrom lize tumorja, ki je lahko smrtno nevaren ali smrten (≥ 4. stopnje).
Your first cycle
Prvi ciklus zdravljenja
Escalate to 28 mcg/day after 7 days if the toxicity does not recur.
Če se toksični učinek ne ponovi, odmerek po 7 dneh povečajte na 28 µg/dan.
11 Rash includes erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular and rash pruritic.
Izpuščaj obsega eritem, izpuščaj, eritematozen izpuščaj, generaliziran izpuščaj, makularen izpuščaj, makulo-papulozen izpuščaj in pruritičen izpuščaj.
Therefore once the CSF is cleared, treatment with BLINCYTO may be initiated.
Zdravilo BLINCYTO se torej lahko uvede, ko je cerebrospinalna tekočina čista.
Powder: citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80 and sodium hydroxide.
Prašek: citronska kislina monohidrat (E330), trehaloza dihidrat, lizinijev klorid, polisorbat 80, natrijev hidroksid in voda za injekcije.
Relapse
• izpuščaj
BLINCYTO was also evaluated in an open-label, multicentre, single-arm phase II study of 189 patients.
Zdravilo BLINCYTO so ocenili tudi v odprti, multicentrični študiji II.
Grade 3 Interrupt BLINCYTO until no more than grade 1 (mild) and for at least 3 days, then restart BLINCYTO at 9 mcg/day.
3. stopnja Prekinite uporabo zdravila BLINCYTO, dokler učinek ni največ 1. stopnje (blag), nato začnite zdravilo znova uporabljati v odmerku 9 µg/dan.
Toxicity
Toksični učinek
Philadelphia chromosome negative relapsed or refractory B-precursor ALL
Recidivna ali refraktarna ALL predhodniških celic B z negativnim Philadelphia kromosomom
Each pack of BLINCYTO contains:
Eno pakiranje vsebuje:
Immune system disorders
Priprava raztopine za infundiranje
- if you are breast-feeding.
- če dojite.
In addition, reactivations of virus infection (e.g. Polyoma (BK)) have been observed in the phase II clinical study in adults with Philadelphia chromosome negative relapsed or refractory B-precursor ALL.
faze pri odraslih bolnikih z recidivno ali refraktarno ALL predhodniških celic B z negativnim Philadelphia kromosomom opazili reaktivacije virusnih okužb (npr. poliom (BK)).
Insomnia
• nespečnost
Ataxia
Odmerek
Citric acid monohydrate (E330) Lysine hydrochloride Polysorbate 80
citronska kislina monohidrat (E330) lizinijev klorid polisorbat 80 natrijev hidroksid (za prilagoditev pH) voda za injekcije
Leukocytosis Lymphopenia
Zdravilo BLINCYTO
Cytokine release syndrome (CRS)
Sindrom sproščanja citokinov
Lymphadenopathy Histiocytosis haematophagic
Bolezni krvi in limfatičnega sistema febrilna nevtropenija anemija nevtropenija trombocitopenija levkopenija levkocitoza limfopenija limfadenopatija hematofagna histiocitoza
n/N Rate (95% CI)
Delež (95 % IZ)
Immunisations
Cepljenja
Blast free hypoplastic or aplastic bone marrow was defined as bone marrow blasts ≤ 5%, no evidence of disease, insufficient recovery of peripheral blood counts: platelets ≤ 50,000/microlitre and/or ANC ≤ 500/microlitre.
brez znakov bolezni in z nezadostnim okrevanjem periferne krvne slike: trombociti ≤ 50.000/mikroliter in/ali absolutno število nevtrofilcev ≤ 500/mikroliter.
Sepsis Pneumonia
Standardna kemoterapija
• increase in your weight
• povečanje telesne mase
Reconstituted solution
Delna remisija
Musculoskeletal and connective tissue disorders
Presnovne in prehranske motnje sindrom lize tumorja
SOC Chemo (N=134)
Standardna kemoterapija (N = 134)
st
Ob
Preparation of the solution for infusion
Povezavo na navodilo za uporabo
Date of first authorisation: 17 July 2017
Datum prve odobritve: 17. julij 2017
I. When you have finished, release your thumb.
I. Ko končate, sprostite palec.
Q2W = every 2 weeks
Q2W = vsaka 2 tedna
Grade 3 and 4 has been observed occasionally.
Občasno so opazovali stopnjo 3 in 4.
After that, you will need to have an injection every two weeks.
Po tem boste injekcije prejemali vsaka dva tedna.
• any part appears cracked or broken.
• je kateri koli del videti počen ali zlomljen.
• Your doctor will decide how much Kyntheum you need and for how long.
• Zdravnik se bo odločil, koliko zdravila Kyntheum potrebujete in kako dolgo.
Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Vaš zdravnik bo redno spremljal vaše stanje, da se prepriča, ali ima vaše zdravljenje želeni učinek.
• if you have an infection which your doctor thinks is important (for example, active tuberculosis).
• če imate okužbo, za katero vaš zdravnik meni, da je pomembna (na primer aktivno tuberkulozo).
A risk to the newborns/infants cannot be excluded.
Tveganja za dojenega novorojenca/otroka ni mogoče izključiti.
AMAGINE-1 was conducted in 661 patients.
Študija AMAGINE-1 je bila opravljena pri 661 bolnikih.
Suicidal ideation and behaviour
Samomorilske misli in vedenje
• Do not use the syringe if:
• Ne uporabite brizge, če:
• Kyntheum is for long-term treatment.
• Zdravilo Kyntheum je namenjeno za dolgoročno zdravljenje.
Not to be sold separately.
Ni namenjeno izdajanju posamično.
Cover with plaster if needed.
Po potrebi ga prekrijte z obližem.
• if you have tuberculosis (TB), have had a positive TB test, or have been in close contact with someone with TB.
• če imate tuberkulozo (TB), ste bili testirani pozitivno za TB ali ste bili v stiku z nekom, ki ima
Only your caregiver can use:
Samo vaš negovalec lahko uporabi:
Laboratoires LEO 39 route de Chartres 28500 Vernouillet France
Laboratoires LEO 39 route de Chartres 28500 Vernouillet Francija
Quality of life/patient reported outcomes
Kakovost življenja/izidi po navedbah bolnikov
• Do not put the syringe back in the refrigerator once it has reached room temperature.
• Ne postavite brizge nazaj v hladilnik, ko enkrat doseže sobno temperaturo.
On a clean, well-lit work surface, place the:
Na čisto, dobro osvetljeno delovno površino položite:
Immediately tell your doctor or seek medical help if you get any signs of a serious infection.
Takoj obvestite svojega zdravnika ali poiščite zdravniško pomoč, če se vam pojavijo kakršni koli znaki resne okužbe.
If you stop treatment, symptoms of psoriasis may come back.
Če prenehate z zdravljenjem, se lahko simptomi psoriaze znova pojavijo.
• Do not leave the syringe in direct sunlight.
• Ne pustite brizge na neposredni sončni svetlobi.
Put the box with any unused syringes back in the refrigerator.
Škatlo z vsemi neuporabljenimi brizgami dajte nazaj v hladilnik.
Approximately 21% of patients had a history of psoriatic arthritis.
Približno 21 % bolnikov je imelo anamnezo psoriaznega artritisa.
You or your caregiver can use:
Vi ali vaš negovalec lahko uporabita:
*p-value vs. corresponding placebo, adjusted for stratification factors <0.001
*p-vrednost v primerjavi z ustreznim placebom, prilagojeno za faktorje stratifikacije < 0,001
Possible serious infections (may affect up to 1 in 100 people), the signs may include:
Možne resne okužbe (se lahko pojavijo pri več kot 1 od 100 ljudi), znaki lahko vključujejo:
Your doctor, pharmacist or nurse will tell you how often to inject the medicine.
Zdravnik, farmacevt ali medicinska sestra vam bodo povedali, kako pogosto injicirati zdravilo.
• If you want to use the same injection area each time, make sure it is not exactly the same spot that you used for a previous injection.
• Če želite za injiciranje vedno uporabiti isti telesni predel, se prepričajte, da ne gre za povsem isto mesto kot pri prejšnjem injiciranju.
• sharps disposal container (colour and appearance of container may differ depending on national requirements).
• zbiralnik za ostre predmete (barva in videz zbiralnika se lahko razlikujeta glede na nacionalne predpise).
sPGA 0 or 1 Week 12 sPGA 0 or 1 Week 52
sPGA 0 ali 1, 12. teden 1 sPGA 0 ali 1, 52. teden 0
Table 2: Overview of the main efficacy results AMAGINE-1
Preglednica 2: Pregled glavnih rezultatov učinkovitosti AMAGINE-1
Carcinogenicity studies with brodalumab have not been conducted.
Študij karcinogenosti z brodalumabom niso izvedli.
Most of these side effects are mild to moderate.
Večina teh neželenih učinkov je blagih do zmernih.
• flu (influenza)
• gripa (influenca),
The maintenance phase in AMAGINE-2 and -3 did not include placebo.
Faza vzdrževanja v študijah AMAGINE-2 in -3 ni vključevala placeba.
AMAGINE-2 and AMAGINE-3
AMAGINE-2 in AMAGINE-3
Important: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose.
Pomembno: če je po odstranitvi brizge videti, kot da je zdravilo še vedno v njej, niste prejeli celotnega odmerka.
Exposure-response analysis indicates that higher brodalumab concentrations are related to better PASI and sPGA response.
Analiza odziva na izpostavljenost je pokazala, da so višje koncentracije brodalumaba povezane z boljšim odzivom PASI in sPGA.
The pharmacokinetics of brodalumab was similar between Japanese and non-Japanese patients with psoriasis.
Druge skupine bolnikov Farmakokinetika brodalumaba je bila podobna pri japonskih in ne-japonskih bolnikih s psoriazo.
Component of a multipack.
Del skupnega pakiranja.
• Do not try to warm the syringe by using a heat source such as hot water or a microwave.
• Ne uporabljajte virov toplote za segrevanje zdravila, kot sta vroča voda ali mikrovalovna pečica.
• if you have recently had or you or your baby are going to have a vaccination, see "Warnings and precautions" in section "2.
• če ste bili pred kratkim cepljeni ali če boste vi ali vaš dojenček cepljeni, glejte »Opozorila in previdnostni ukrepi« v poglavju »2.
PASI 75 Week 52 (%)
PASI 75, 12. teden (%) PASI 75, 52. teden (%)
Brodalumab clearance decreases with increasing dose and exposure increases in a greater than doseproportional manner.
Očistek brodalumaba se zmanjšuje s povečanjem odmerka in izpostavljenost narašča bolj kot proporcionalno glede na odmerek.
PSI = Psoriasis Symptom Inventory.
PSI = inventar simptomov psoriaze (Psoriasis Symptom Inventory).
Infections Kyntheum may increase the risk of infections.
Zdravilo Kyntheum lahko poveča tveganje za razvoj okužb.
Let your skin dry.
Počakajte, da se koža osuši.
C. Collect all the materials you need
C. Pripravite vse potrebne pripomočke.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil je treba jasno dokumentirati ime in številko serije prejetega zdravila.
Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Pri nekaterih bolnikih z začetnim delnim odzivom se stanje ob nadaljevanju zdravljenja preko 16 tednov lahko izboljša.
• if you are taking, have recently taken or might take any other medicines
• če uporabljate, ste pred kratkim uporabljali ali boste morda začeli uporabljati katero koli drugo zdravilo,