natgillin/translations-raw huggingface dataset:
Do not use the pen if the date has passed.
Ne uporabite peresnika, če je ta datum že mimo.
Distribution In patients with RA, the apparent volume of distribution at steady state was 8.3 L.
Pri bolnikih z RA je bil navidezni volumen porazdelitve v stanju dinamičnega ravnovesja 8,3 l. Biotransformacija
Kevzara is given as an injection under the skin (called “subcutaneous” injection).
Zdravilo Kevzara se daje v injekcijah pod kožo (subkutanih injekcijah).
• Use your thumb and first (index) finger to pinch a fold of skin at the injection site.
• S palcem in kazalcem stisnite, da boste na mestu injiciranja naredili kožno gubo.
In the placebo-controlled population, the proportion of patients who discontinued treatment due to hypersensitivity reactions was higher among those treated with Kevzara (0.9% in 200 mg group, 0.5% in 150 mg group) than placebo (0.2%).
V populaciji, kontrolirani s placebom, je bil delež bolnikov, ki so zdravljenje prenehali zaradi preobčutljivostnih reakcij, med prejemniki zdravila Kevzara večji (0,9 % v skupini z 200 mg, 0,5 % v skupini s 150 mg) kot med prejemniki placeba (0,2 %).
Anti Drug Antibody (ADA) formation may affect pharmacokinetics of Kevzara.
Nastajanje protiteles proti zdravilu lahko vpliva na farmakokinetiko zdravila Kevzara.
The metabolic pathway of sarilumab has not been characterised.
Presnovna pot sarilumaba ni ugotovljena.
A more than dose-proportional increase in pharmacokinetic exposure was observed in patients with RA.
Pri bolnikih z RA so opažali več kot odmerku sorazmerno povečanje farmakokinetične izpostavljenosti.
Following single-dose sarilumab administration, in patients with RA, ANC decreased to the nadir between 3 to 4 days and thereafter recovered towards baseline (see section 4.4).
Po enkratnem odmerku sarilumaba je AŠN pri bolnikih z RA doseglo najnižjo točko od 3. do 4. dne, potem pa se je vrnilo proti izhodiščnemu (glejte poglavje 4.4).
Keep the remaining syringe in the carton in the refrigerator.
Preostalo brizgo pustite v škatli v hladilniku.
Treatment with Kevzara was associated with a higher incidence of transaminase elevations.
Zdravljenje z zdravilom Kevzara je bilo povezano z večjo pojavnostjo zvišanja transaminaz.
• you have any infection or you get a lot of infections.
• imate kakšno okužbo, ali če imate pogosto okužbe.
In patients who develop elevated ALT greater than 5 x ULN, treatment with Kevzara should be discontinued (see section 4.2).
Bolnikom, ki se jim ALT zviša na več kot 5-kratno ZNM, je treba zdravljenje z zdravilom Kevzara prenehati (glejte poglavje 4.2).
• Pull the needle out at the same angle it was injected.
• Izvlecite iglo pod istim kotom, kot ste jo zabodli.
Do not inject into skin that is tender, damaged or has bruises or scars.
Ne injicirajte v kožo, ki je občutljiva, poškodovana, imate podplutbe ali brazgotine.
No long-term animal studies have been performed to establish the carcinogenicity potential of sarilumab.
Dolgoročnih študij na živalih za ugotavljanje kancerogenosti sarilumaba niso izvedli.
Consider the risks and benefits of treatment prior to initiating Kevzara in patients who have:
Pred uvedbo zdravila Kevzara je treba pretehtati tveganja in koristi zdravljenja pri bolnikih, ki imajo:
• you have had diverticulitis (a condition of the lower bowel) or ulcers in your stomach or intestines, or develop symptoms such as fever and stomach (abdominal) pain that does not go away.
• ste imeli divertikulitis (to je bolezen spodnjega dela črevesa) ali razjede na želodcu ali v črevesju, ali če se vam pojavijo simptomi, kot so zvišana telesna temperatura ali bolečine v trebuhu, ki ne minejo.
Patients had at least 8 tender and 6 swollen joints at baseline.
Bolniki so imeli na začetku študije vsaj 8 občutljivih sklepov in 6 oteklih sklepov.
• Take one syringe out of the packaging by holding the middle of the syringe body.
• Vzemite brizgo iz pakiranja tako, da jo primete na sredi telesa brizge.
Animal studies showed no impairment of male or female fertility (see section 5.3).
Študije na živalih niso pokazale okvare plodnosti samcev ali samic (glejte poglavje 5.3).
Proper training should be provided to patients and/or caregivers on the preparation and administration of Kevzara prior to use.
Bolnikom in/ali negovalcem je treba pred takšno uporabo zagotoviti ustrezno usposabljanje o pripravi in dajanju zdravila.
Kevzara has not been studied in patients with severe renal impairment (see section 5.2).
Zdravilo Kevzara ni raziskano pri bolnikih s hudo okvaro ledvic (glejte poglavje 5.2).
If the window does not turn fully yellow, do not give yourself a second dose without speaking to your healthcare provider.
Če okence ne postane povsem rumeno, si ne dajte še enega odmerka, ne da bi se posvetovali z zdravnikom, farmacevtom ali medicinsko sestro.
Following single-dose subcutaneous (SC) administration of sarilumab 200 mg and 150 mg in patients with RA rapid reduction of CRP levels was observed.
Po enkratni subkutani (s.c.) uporabi 200 mg in 150 mg sarilumaba so pri bolnikih z RA opažali hitro znižanje koncentracije CRP.
For recommended dose modifications based on transaminase elevations see section 4.2.
Za priporočila o prilagoditvi odmerka glede na zvišanje transaminaz glejte poglavje 4.2.
• Take one pen out of the packaging by holding the middle of the pen body.
• Vzemite peresnik iz pakiranja tako, da ga primete na sredi telesa peresnika.
In patients with higher body weight (>100 Kg) both 150 mg and 200 mg doses demonstrated efficacy; however, patients weighing >100 Kg had greater therapeutic benefit with the 200 mg dose.
sta bila oba odmerka - 150 mg in 200 mg - učinkovita, toda bolnikom z maso > 100 kg je terapevtsko bolj koristil odmerek 200 mg.
Store pre-filled syringe/pre-filled pen in the original carton in order to protect from light.
Napolnjeno injekcijsko brizgo/napolnjeni injekcijski peresnik shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
Patients should be closely monitored for the development of signs and symptoms of infection during treatment with Kevzara (see sections 4.2 and 4.8).
Bolnike je treba med zdravljenjem z zdravilom Kevzara skrbno nadzorovati glede pojava znakov ali simptomov okužbe (glejte poglavji 4.2 in 4.8).
ALT > 3 to 5 x ULN Treatment with Kevzara should be withheld until < 3 x ULN.
ALT > 3- do 5-kratna ZNM Zdravljenje z zdravilom Kevzara je treba prekiniti, dokler ni vrednost < 3-kratna ZNM.
Avoid concurrent use of live vaccines as well as live attenuated vaccines during treatment with Kevzara as clinical safety has not been established.
Med zdravljenjem z zdravilom Kevzara se izogibajte sočasni uporabi živih cepiv in živih oslabljenih cepiv, ker klinična varnost ni ugotovljena.
Table 4: Mean reductions from baseline to Week 24 in components of ACR score
Preglednica 4: Povprečna znižanja komponent ocene ACR od izhodišča do 24. tedna
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist.
Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom ali farmacevtom.
Body weight influenced the pharmacokinetics of sarilumab.
Telesna masa je vplivala na farmakokinetiko sarilumaba.
Solution for injection (injection) Clear, colourless to pale yellow sterile solution of approximately pH 6.0.
raztopina za injiciranje (injekcija) Bistra, brezbarvna do bledorumena sterilna raztopina, ki ima pH približno 6,0.
No formal study of the effect of hepatic impairment on the pharmacokinetics of sarilumab was conducted (see section 4.2).
Okvara jeter Formalnih študij vpliva okvare jeter na farmakokinetiko sarilumaba niso izvedli (glejte poglavje 4.2).
The recommended dose of Kevzara is 200 mg once every 2 weeks administered as a subcutaneous injection.
Priporočeni odmerek zdravila Kevzara je 200 mg enkrat na 2 tedna v subkutani injekciji.
In patients experiencing liver enzyme elevation, modification of treatment regimen, such as interruption of Kevzara or reduction in dose, resulted in decrease or normalization of liver enzymes (see section 4.2).
Pri bolnikih, ki so se jim zvišale vrednosti jetrnih encimov, je prilagoditev sheme zdravljenja (npr. prekinitev uporabe zdravila Kevzara ali zmanjšanje odmerka) prinesla znižanje ali normalizacijo jetrnih encimov (glejte poglavje 4.2).
* q2w=every two weeks † p-value <0.001 ††p-value <0.0001 ‡ Primary end point
* na 2t = na 2 tedna † Vrednost p < 0,001 ††Vrednost p < 0,0001 ‡ Primarni opazovani dogodek
A patient may self-inject Kevzara or the patient's caregiver may administer Kevzara if their healthcare professional determines that it is appropriate.
Bolniki si lahko zdravilo Kevzara injicira sam ali mu zdravilo injicira njegov negovalec, če zdravnik presodi, da je to primerno.
• IL-6 plays a major role in the symptoms of rheumatoid arthritis such as pain, swollen joints,
• IL-6 igra pomembno vlogo pri simptomih revmatoidnega artritisa, npr. pri bolečinah, oteklosti sklepov, jutranji okorelosti in utrujenosti.
For the 150 mg every two weeks dose regimen, the estimated mean (± standard deviation, SD) steadystate area under curve (AUC), Cmin, and Cmax of sarilumab were 210 ± 115 mg.day/L, 6.95 ± 7.60 mg/L, and 20.4 ± 8.27 mg/L, respectively.
Z odmerno shemo 150 mg na 2 tedna so bila za sarilumab v stanju dinamičnega ravnovesja ocenjena povprečja (± standardni odklon): površina pod krivuljo (AUC) 210 ± 115 mg.dan/l, Cmin 6,95 ± 7,60 mg/l in Cmax 20,4 ± 8,27 mg/l.
In patients who develop an ANC less than 0.5 x 109/L, treatment with Kevzara should be discontinued.
Pri bolnikih, ki se jim AŠN zmanjša na manj kot 0,5 x 109/l, je treba zdravljenje z zdravilom Kevzara prenehati.
No formal study of the effect of renal impairment on the pharmacokinetics of sarilumab was conducted.
Formalnih študij vpliva okvare ledvic na farmakokinetiko sarilumaba niso izvedli.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Kevzara.
Če kaj od naštetega velja za vas (ali če ste negotovi), se pred začetkom uporabe zdravila Kevzara posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Table 1: ADRs in controlled clinical studies
Preglednica 1: Neželeni učinki zdravila v kontroliranih kliničnih študijah
In both studies, patients treated with either 200 mg or 150 mg of Kevzara + DMARDs every two weeks had higher ACR20, ACR50, and ACR70 response rates versus placebo-treated patients at Week 24.
V obeh študijah so imeli bolniki, zdravljeni z 200 mg ali 150 mg zdravila Kevzara v kombinaciji z DMARD na dva tedna, 24. teden višje deleže odzivov ACR20, ACR50 in ACR70 kot bolniki, ki so prejemali placebo.
Keep the remaining pen in the carton in the refrigerator.
Preostali peresnik pustite v škatli v hladilniku.
• infections in your sinuses or throat, blocked or runny nose and sore throat (upper respiratory tract infection)
• okužba v obnosnih votlinah (sinusih) ali žrelu, zamašen nos ali izcedek iz nosu in vneto žrelo (okužba zgornjih dihal)
If you are unsure when to inject your next dose: ask your doctor, pharmacist or nurse for instructions.
Če ste negotovi glede tega, kdaj injicirati naslednji odmerek, za nasvet prosite zdravnika, farmacevta ali medicinsko sestro.
In patients experiencing a decrease in absolute neutrophil count (ANC), modification of treatment regimen such as interruption of Kevzara or reduction in dose resulted in an increase or normalization of ANC (see section 4.2).
Pri bolnikih, ki se jim je zmanjšalo absolutno število nevtrofilcev (AŠN), je prilagoditev sheme zdravljenja (npr. prekinitev uporabe zdravila Kevzara ali zmanjšanje odmerka) prinesla povečanje ali normalizacijo AŠN (glejte poglavje 4.2).
Kevzara should not be administered to patients with known hypersensitivity to sarilumab (see section 4.3).
Zdravila Kevzara ne smejo dobiti bolniki z znano preobčutljivostjo za sarilumab (glejte poglavje 4.3).
Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating treatment with Kevzara.
Bolnike je treba pred uvedbo zdravila Kevzara oceniti glede dejavnikov tveganja za tuberkulozo in jih testirati za latentno okužbo.
It contains 150 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.
Vsebuje 150 mg zdravila Kevzara za podkožno injiciranje (subkutano injiciranje) enkrat na dva tedna.
Initiating treatment with Kevzara is not recommended in patients with elevated transaminases, ALT or AST greater than 1.5 x ULN.
Uvedba zdravljenja z zdravilom Kevzara ni priporočljiva pri bolnikih z zvišanimi transaminazami, ALT ali AST na 1,5-kratno ZNM.
• Change injection site each time you inject.
• Vsakič, ko zdravilo injicirate, uporabite drugo injekcijsko mesto.
Events of gastrointestinal perforation have been reported in clinical studies, primarily as complications of diverticulitis.
V kliničnih študijah so bili opisani primeri perforacije prebavil, predvsem kot zaplet divertikulitisa.
• If you see any blood, press a cotton ball or gauze on the site.
• Če opazite kri, na mesto injiciranja pritisnite s kosmom vate ali zložencem iz gaze.
Following these instructions, Kevzara can be self-injected or administered by a care-giver.
Ob upoštevanju teh navodil, si lahko zdravilo Kevzara injicirate sami ali vam ga injicira oseba, ki skrbi za vas.
Keep unused syringes in the original carton and store in the refrigerator between 2ºC and 8ºC.
Neuporabljene peresnike shranjujte v originalni škatli in v hladilniku na temperaturi od 2 do 8°C.
Kevzara has not been investigated in combination with Janus kinase (JAK) inhibitors or biological DMARDs such as Tumor Necrosis Factor (TNF) antagonists.
Zdravilo Kevzara ni raziskano v kombinaciji z zaviralci Janus-kinaze (JAK) ali z biološkimi DMARD,
Serious side effect
Resen neželen učinek
Non-clinical data reveal no special hazard for humans based on repeated-dose toxicity studies, carcinogenic risk assessment and reproductive and developmental toxicity studies.
5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi študij toksičnosti pri ponavljajočih odmerkih, kancerogenega potenciala ter vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Kevzara Monotherapy Any Dose N = 467
Monoterapija z zdravilom Kevzara, kateri koli odmerek N = 467
Do not expose the syringe to direct sunlight.
Ne izpostavljajte peresnika neposredni sončni svetlobi.
Table 5: Mean Radiographic Change from Baseline at Week 24 and Week 52 in MOBILITY
Preglednica 5: Povprečna rentgenografska sprememba po 24 tednih in 52 tednih v primerjavi z izhodiščem v študiji MOBILITY
How to use Kevzara
Kako uporabljati zdravilo Kevzara
If confirmed by repeat testing, treatment with Kevzara should be discontinued.
Če je potrjeno s ponovnim testiranjem, je treba zdravljenje z zdravilom
Pull off the needle cap.
Snemite pokrovček igle.
The solution should not be used if it is cloudy, discoloured, or contains particles, or if any part of the device appears to be damaged.
Raztopine se ne sme uporabiti, če je motna, spremenjene barve ali vsebuje delce, ali če je kateri koli del pripomočka videti poškodovan.
The overall rates of infections and serious infections in the Kevzara monotherapy population were consistent with rates in the Kevzara + DMARDs population.
Celotni deleži okužb in resnih okužb so se v populaciji, ki je prejemala monoterapijo z zdravilom Kevzara, skladali z deleži v populaciji, ki je prejemala kombinacije zdravila Kevzara + DMARD.
Talk to your doctor before using Kevzara if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite zdravilo Kevzara.
* q2w = every 2 weeks ‡ Visual analogue scale †p-value <0.01 for difference from placebo ††p-value <0.001 for difference from placebo †††p-value <0.0001 for difference from placebo
* na 2t = na 2 tedna ‡ Vizualna analogna skala †Vrednost p < 0,01 za razliko od placeba.
Kevzara 150 mg + cDMARD
Kevzara 150 mg + kDMARD
After the last steady state dose of 150 mg and 200 mg sarilumab, the median times to non-detectable concentration are 30 and 49 days, respectively.
Po zadnjem odmerku sarilumaba v stanju dinamičnega ravnovesja je mediani čas do nezaznavne koncentracija po 150 mg 30 dni in po 200 mg 49 dni.
Kevzara 200 mg + cDMARD
Kevzara 200 mg + kDMARD
Do not
Česa ne smete
In MOBILITY and TARGET, patients receiving sarilumab 200 mg + DMARDs every two weeks or sarilumab 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline compared to placebo + DMARDs.
V študijah MOBILITY in TARGET so prejemniki 200 mg sarilumaba + DMARD na 2 tedna ali 150 mg sarilumaba + DMARD na 2 tedna dosegli v primerjavi z izhodiščem večje izboljšanje kot prejemniki placeba + DMARD.
For the 200 mg every two weeks dose regimen, the estimated mean (± SD) steady-state AUC, Cmin and Cmax of sarilumab were 396 ± 194 mg.day/L, 16.7 ± 13.5 mg/L, and 35.4 ± 13.9 mg/L, respectively.
Z odmerno shemo 200 mg na 2 tedna so bila za sarilumab v stanju dinamičnega ravnovesja ocenjena povprečja (± standardni odklon): AUC 396 ± 194 mg.dan/l, Cmin 16,7 ± 13,5 mg/l in Cmax 35,4 ± 13,9
Comprehensive instructions for the administration of Kevzara in a pre-filled syringe/pre-filled pen are given in the package leaflet.
Natančna navodila za dajanje zdravila Kevzara v napolnjeni injekcijski brizgi/napolnjenem injekcijskem peresniku so navedena v navodilu za uporabo.
Sarilumab is a human monoclonal antibody (IgG1 subtype) that specifically binds to both soluble and membrane-bound IL-6 receptors (IL-6Rα), and inhibits IL-6-mediated signalling which involves ubiquitous signal-transducing glycoprotein 130 (gp130) and the Signal Transducer and Activator of Transcription-3 (STAT-3).
Sarilumab zavira z IL-6 posredovano signalizacijo, ki vključuje splošni prenašalec signalov glikoprotein 130 (gp 130) in STAT-3 (Signal Transducer and
The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a light-orange polypropylene finger flange.
Napolnjena injekcijska brizga za enkratno uporabo ima pokrovček igle iz stiren-butadienskega elastomera in je opremljena z belim polistirenskim batnim zamaškom ter svetlooranžnim polipropilenskim držalom za prste.
In the placebo-controlled population, malignancies occurred at the same rate in patients receiving either Kevzara + DMARDs or placebo + DMARDs (1.0 events per 100 patient-years).
V populaciji, kontrolirani s placebom, so se maligne bolezni pri prejemnikih zdravila Kevzara + DMARD pojavile v enakem deležu kot pri prejemnikih placeba + DMARD (1,0 dogodek na 100 bolnik-let).
This device is a single-dose pre-filled pen (called “pen” in these instructions).
Ta pripomoček je napolnjeni injekcijski peresnik z enim odmerkom (v teh navodilih jo imenujemo preprosto "peresnik").
The efficacy and safety of Kevzara were assessed in three randomised, double-blind, controlled multicentre studies (MOBILITY and TARGET were placebo-controlled studies and MONARCH was an active comparator-controlled study) in patients older than 18 years with moderately to severely active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria.
Učinkovitost in varnost zdravila Kevzara so raziskali v treh randomiziranih, dvojno slepih, kontroliranih multicentričnih študijah (študiji MOBILITY in TARGET sta bili kontrolirani s placebom, študija MONARCH pa je bila kontrolirana z zdravilno učinkovino).
No dose adjustment is required in patients with mild to moderate renal impairment.
Bolnikom z blago do zmerno okvaro ledvic odmerka ni treba prilagoditi.
The modulation of IL-6 effect on CYP enzymes by sarilumab may be clinically relevant for CYP substrates with a narrow therapeutic index, where the dose is individually adjusted.
Modulacija učinka IL-6 na encime CYP s sarilumabom je lahko klinično pomembna za substrate CYP
It contains 200 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.
Vsebuje 200 mg zdravila Kevzara za podkožno injiciranje (subkutano injiciranje) enkrat na dva tedna.
This device is a single-dose pre-filled syringe (called “syringe” in these instructions).
Ta pripomoček je napolnjena injekcijska brizga z enim odmerkom (v teh navodilih jo imenujemo preprosto "brizga").
Liver Enzyme Abnormalities Lab Value
Nepravilnosti jetrnih encimov Laboratorijska vrednost Priporočilo
In patients who develop a platelet count less than 50 x 103/ µL, treatment with Kevzara should be discontinued.
Pri bolnikih, ki se jim število trombocitov zmanjša pod 50 x 10 3/µl, je treba zdravljenje z zdravilom Kevzara prenehati.
Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving immunosuppressive agents including Kevzara for RA.
Pri bolnikih, ki so prejemali imunosupresivna zdravila, vključno z zdravilom Kevzara za RA, so poročali o resnih in včasih smrtnih okužbah z bakterijami, mikobakterijami, invazivnimi glivami, virusi ali drugimi oportunističnimi patogeni.
ACR50 response, n (%)
Odziv ACR50, n (%)
Hypersensitivity reactions have been reported in association with Kevzara (see section 4.8).
V povezavi z zdravilom Kevzara so bile opisane preobčutljivostne reakcije (glejte poglavje 4.8).
ACR20 response, n (%)
Odziv ACR20, n (%)
Initiating treatment with Kevzara is not recommended in patients with a low neutrophil count, i.e., absolute neutrophil count (ANC) less than 2 x 109/L.
Zdravila Kevzara ni priporočljivo uvesti bolnikom, ki imajo majhno število nevtrofilcev, tj. absolutno število nevtrofilcev (AŠN) manj kot 2 x 109/l.
Learning how to use the pre-filled syringe
Učenje uporabe napolnjene injekcijske brizge
ALT and AST levels should be monitored 4 to 8 weeks after start of therapy and every 3 months thereafter.
Raven ALT in AST je treba kontrolirati od 4 do 8 tednov po začetku zdravljenja, nato pa na 3 mesece.
sanofi-aventis groupe: 54, rue la Boétie 75008 Paris France
sanofi-aventis groupe: 54, rue la Boétie 75008 Paris Francija
Treatment should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of rheumatoid arthritis.
4.2 Odmerjanje in način uporabe Zdravljenje mora začeti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa.
Do not inject if the liquid is cloudy, discoloured or contains particles.
Ne injicirajte zdravila, če je tekočina motna, spremenjene barve ali vsebuje delce.
Do not use the syringe if it has been damaged or the needle cap is missing or not attached.
Ne uporabite brizge, če je poškodovana, če pokrovček igle manjka ali če ni nameščen.
It is available in pack sizes of 1 or 2 or a multipack of 6 pre-filled syringes (3 packs of 2).
Na voljo je v pakiranjih z 1 ali 2 napolnjenima injekcijskima brizgama ali skupnih pakiranjih s 6 napolnjenimi injekcijskimi brizgami (3 pakiranja po 2).
In an enhanced pre-/postnatal developmental toxicity study, pregnant Cynomolgus monkeys were administered sarilumab once-weekly intravenously from early gestation to natural birth (approximately 21 weeks) Maternal exposure up to approximately 83 times the human exposure based on AUC after subcutaneous doses of 200 mg every 2 weeks, did not cause any maternal or embryofetal effects.
V stopnjevani pre-/postnatalni študiji razvojne toksičnosti so brejim opicam Cynomolgus enkrat na teden dajali sarilumab intravensko od zgodnje gestacije do naravnega poroda (približno 21 tednov).
Kevzara 150 mg solution for injection in pre-filled syringe Kevzara 150 mg solution for injection in pre-filled pen Kevzara 200 mg solution for injection in pre-filled syringe Kevzara 200 mg solution for injection in pre-filled pen
Kevzara 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Kevzara 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Kevzara 200 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Kevzara 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
DAS28-CRP remission (< 2.6) ACR20
12. teden Remisija DAS28CRP (< 2,6) ACR20