natgillin/translations-raw huggingface dataset:
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
Ask your doctor, nurse or pharmacist for advice before taking any medicine.
Posvetujte se z zdravnikom, medicinsko sestro ali s farmacevtom, preden vzamete katero koli zdravilo.
However, treatment with immunosuppressants, including Rilonacept Regeneron, may result in an increase in the risk of malignancies.
Vendar pa lahko zdravljenje z imunosupresivi, vključno z zdravilom Rilonacept Regeneron, zveča tveganje malignih bolezni.
Intravenous administration of Rilonacept Regeneron at doses of up to 2000 mg monthly in another patient population for up to six months was generally well-tolerated.
Intravensko dajanje zdravila Rilonacept Regeneron v odmerkih do 2.000 mg na mesec do šest mesecev so bolniki v neki drugi populaciji na splošno dobro prenašali.
Please read the section “INSTRUCTIONS FOR USE OF RILONACEPT REGENERON POWDER FOR SOLUTION FOR INJECTION” at the end of this leaflet.
Prosimo vas, da preberete poglavje »NAVODILA ZA UPORABO ZDRAVILA RILONACEPT REGENERON PRAŠEK ZA RAZTOPINO ZA INJICIRANJE« na koncu tega navodila.
• Tell your doctor about any skin reactions including redness, swelling, or hardening of the skin.
• Obvestite zdravnika o morebitnih kožnih reakcijah, vključno z rdečino, oteklino ali zatrdlino kože.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 to 8°C.
Če se zdravilo ne uporabi takoj, je za čas shranjevanja do uporabe, ki normalno ne sme presegati 24 ur pri temperaturi 2 C do 8 C, in pogoje pred uporabo odgovoren uporabnik.
• Skin, eye, or ear infection
• okužbe kože, oči ali ušes;
Due to the small patient population, an ADR reported in 2 or more patients is classified as “common.”
Ker je skupina bolnikov majhna, je neželen učinek, o katerem so poročali pri 2 ali več bolnikih, uvrščen med “pogoste”.
• If you touch a needle or the needle touches any surface, throw away the entire syringe into your puncture-resistant container and start over with a new syringe.
• Če se dotaknete igle ali pa se z iglo dotaknete katere koli druge površine, celotno injekcijsko brizgo zavrzite v vsebnik, odporen na vbode, in postopek ponovno začnite z novo injekcijsko brizgo.
Rilonacept Regeneron blocks the activity of substances including interleukin-1 beta (IL-1 beta).
Zdravilo Rilonacept Regeneron blokira aktivnost na primer interlevkina-1 beta (IL-1 beta).
See also section 3, “How to inject Rilonacept Regeneron.”
Glejte tudi poglavje 3 »Kako injicirati zdravilo Rilonacept Regeneron«.
• Bronchitis
• bronhitis;
• After that, the recommended dose is 1 injection of 2 ml injected once weekly.
• Po tem je priporočeni odmerek 1 injekcija po 2 ml, injicirana enkrat na teden.
This may lead to symptoms such as fever, headache, fatigue, skin rash, or painful joints and muscles.
To lahko povzroči simptome, na primer zvišano telesno temperaturo, glavobol, utrujenost, kožni izpuščaj ali bolečine v sklepih in mišicah.
Rilonacept also binds the endogenous IL-1 receptor antagonist (IL-1ra) but with a lower affinity than IL-1β or IL-1α.
Rilonacept veže tudi endogeni antagonist receptorja IL-1 (IL-1ra), vendar z manjšo afiniteto kot IL-1β ali IL-1α.
Prior to initiation of Rilonacept Regeneron therapy, adult and paediatric patients should receive all recommended vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine.
Pred uvedbo zdravljenja z zdravilom Rilonacept Regeneron naj odrasli bolniki in otroci prejmejo vsa priporočena cepiva, pač glede na primer, vključno s pnevmokoknim cepivom in inaktiviranim cepivom proti gripi.
Nineteen of 55 patients (35%) who had received Rilonacept Regeneron for at least 6 weeks tested positive for treatment-emergent binding antibodies on at least one occasion.
Devetnajst od 55 bolnikov (35 %), ki so vsaj 6 tednov prejemali zdravilo Rilonacept Regeneron, je bilo vsaj enkrat pozitivnih na testu za ugotavljanje prisotnosti med zdravljenjem nastalih vezavnih protiteles.
All cases in the clinical trials had a confirmed mutation in the NLRP3 gene.
Vsi bolniki v kliničnih preskušanjih so imeli potrjeno mutacijo gena NLRP3.
Some symptoms associated with CAPS or with Rilonacept Regeneron treatment, such as a spinning sensation (known as vertigo), may affect your ability to drive or use machines.
Nekateri simptomi, povezani s CAPS ali z zdravljenjem z zdravilom Rilonacept Regeneron, na primer občutek vrtenja (vrtoglavica ali vertigo) lahko poslabšajo sposobnost vožnje ali upravljanja s stroji.
After the needle is completely in the skin, let go of the skin that you are pinching.
Ko je igla do konca v koži, spustite kožno gubo, ki ste jo držali.
In a prenatal and postnatal reproductive toxicology study in which mice were dosed subcutaneously, with a murine analogue of rilonacept at doses of 20, 100 or 200 mg/kg three times per week (the highest dose is approximately 6-fold higher than the 160 mg maintenance dose based on body surface area), there were no treatment-related effects.
V študiji prenatalne in postnatalne reproduktivne toksikologije, v kateri so miši subkutano prejemale mišji analog rilonacepta v odmerkih 20, 100 ali 200 mg/kg trikrat na teden (največji odmerek je približno šestkrat večji od vzdrževalnega odmerka 160 mg na podlagi telesne površine), niso ugotovili nobenih učinkov, povezanih s prejemanjem zdravila.
Rilonacept Regeneron belongs to a group of medicines called interleukin inhibitors.
Zdravilo Rilonacept Regeneron pripada skupini zdravil, ki se imenujejo zaviralci interlevkinov.
The adult loading dose should be administered as two 2 ml subcutaneous injections (320 mg of rilonacept in total) given on the same day at different sites.
Polnitveni odmerek za odrasle je treba dati v obliki dveh 2-mililitrskih subkutanih injekcij (skupaj 320 mg rilonacepta) istega dne na različnih mestih.
A significantly higher proportion of patients in the rilonacept group compared to the placebo group experienced improvement from baseline in the composite score by at least 30% (96% vs. 29% of patients), by at least 50% (87% vs. 8%) and by at least 75% (70% vs. 0%) (p<0.0001).
Signifikantno večjemu deležu bolnikov v skupini z rilonaceptom kot v skupini s placebom se je sestavljeni rezultat izboljšal od izhodišča za vsaj 30 % (96 % proti 29 % bolnikov), za vsaj 50 % (87 % proti 8 %) in za vsaj 75 % (70 % proti 0 %) (p<0,0001).
The first injection of Rilonacept Regeneron should be given under the supervision of a trained healthcare professional.
Prvo injekcijo zdravila Rilonacept Regeneron je treba dati pod nadzorstvom usposobljenega zdravstvenega delavca.
Further PK steady state exposure data (AUC, Cmax, Cmin during steady state) especially for paediatric subjects is required.
Potrebni so dodatni PK podatki o izpostavljenosti v stanju dinamičnega ravnovesja (AUC, Cmax, Cmin v stanju dinamičnega ravnovesja), še posebno za otroke.
In a study in patients with polymyalgia rheumatica, one patient developed bronchitis and sinusitis, which resulted in hospitalization.
V študiji bolnikov z revmatično polimialgijo sta se pri enem bolniku razvila bronhitis in sinuzitis, zaradi katerih je bil bolnik hospitaliziran.
In a study in patients with adult Still's disease, one patient developed an infection in his elbow with Mycobacterium intracellulare after an intraarticular glucocorticoid injection and subsequent local exposure to a suspected source of mycobacteria.
V študiji na bolnikih s Stillovo boleznijo odraslih se je pri enem bolniku po intraartikularni injekciji glukokortikoidov in poznejši lokalni izpostavljenosti sumljivemu viru mikobakterij v komolcu razvila okužba z Mycobacterium intracellulare.
Immediately after Part A patients entered Part B which consisted of a 9-week, patient-blind period during which all patients received rilonacept 160 mg weekly, followed by a 9-week, double-blind, randomised withdrawal period in which patients were randomly assigned to either remain on rilonacept 160 mg weekly or to receive placebo.
Takoj po delu A so bolniki vstopili v del B, ki ga je sestavljalo 9-tedensko, za bolnike slepo obdobje, med katerim so vsi bolniki prejemali rilonacept v odmerku 160 mg na teden, ki mu je sledilo 9-tedensko dvojno slepo, randomizirano obdobje odtegnitve, v katerem so bili bolniki naključno izbrani, da ostanejo na rilonaceptu v odmerku 160 mg na teden ali da prejemajo placebo.
The efficacy was not evaluated in patients without a confirmed NLRP3/CIAS1 gene mutation.
Učinkovitosti niso ugotavljali pri bolnikih brez potrjene mutacije gena NLRP3/CIAS1.
• Serious infections.
• Resne okužbe.
Rilonacept also led to a significant decrease in serum amyloid A (SAA) versus baseline to levels within the normal range.
Rilonacept je privedel tudi do tudi signifikantno znižanja plazemskega amiloid A (SAA) glede na izhodiščno vrednost na ravni v normalnih mejah.
Push the plunger down and inject all the air into the vial (see Figure 10).
Potisnite bat navzdol in injicirajte ves zrak v vialo (glejte sliko 10).
The resulting 80 mg/ml solution is sufficient to allow a withdrawable volume of up to 2 ml for subcutaneous administration.
Nastale raztopine z 80 mg/ml je dovolj, da lahko iz nje povlečete volumen do 2 ml za subkutano aplikacijo.
After proper training in the correct injection technique, patients may self-inject Rilonacept Regeneron if their physician determines that it is appropriate and with medical follow-up as necessary.
Potem ko bolnike ustrezno izobrazijo o pravilni tehniki injiciranja, si lahko zdravilo Rilonacept Regeneron injicirajo sami, če njihov zdravnik ugotovi, da je to primerno in da je na voljo medicinska podpora, če je potrebno.
Upon initiation of Rilonacept Regeneron, in patients being treated with these types of medicinal products, therapeutic monitoring of the effect or plasma levels should be performed and the individual dose of the medicinal product may need to be adjusted as needed.
Po uvedbi zdravila Rilonacept Regeneron je treba pri bolnikih, ki se zdravijo s temi vrstami zdravil, terapevtsko spremljati učinek ali plazemske koncentracije in po potrebi prilagoditi individualni odmerek zdravila.
Part A was a 6-week, randomised, double-blind, placebo-controlled period to evaluate rilonacept at a dose of 160 mg weekly after an initial loading dose of 320 mg.
Del A je bilo 6-tedensko randomizirano, dvojno slepo, s placebom kontrolirano obdobje za oceno rilonacepta v odmerku 160 mg na teden po začetnem polnitvenem odmerku 320 mg.
In clinical studies, CAPS patients who have uncontrolled over-production of IL-1β show a rapid response to therapy with rilonacept, i.e. laboratory parameters such as C-reactive protein (CRP) and serum amyloid A (SAA) levels, leukocytosis, and high platelet count rapidly returned to normal.
V kliničnih študijah se bolniki s CAPS, ki imajo nenadzorovano hiperprodukcijo IL-1βhitro odzovejo na zdravljenje z rilonaceptom, t.j., laboratorijski parameteri, na primer koncentracije C-reaktivnega proteina (CRP) in serumskega amiloida A (SAA), levkocitoza in zvišana koncentracija trombocitov, se hitro vrnejo na normalne vrednosti.
Pull the needle out of the skin, and hold a piece of sterile gauze over the injection site for several seconds.
Povlecite iglo iz kože in nekaj sekund držite kos sterilne gaze na mestu injiciranja.
In placebo-controlled studies across a variety of patient populations encompassing 336 patients treated with rilonacept and 165 treated with placebo, the incidence of infections was 6.8% and 3% (0.44 per patient-exposure year and 0.19 per patient-exposure year), respectively, for rilonacept and placebo.
V študijah, kontroliranih s placebom, pri različnih skupinah bolnikov, ki so zajele 336 bolnikov, zdravljenih z rilonaceptom, in 165 bolnikov, ki so prejemali placebo, je bila incidenca okužb pri rilonaceptu 6,8 %, pri placebu pa 3 % (0,44 na leto bolnikove izpostavljenosti oziroma 0,19 na leto bolnikove izpostavljenosti).
Week 24 Mean KSS
Srednji KSS v 24. tednu
Age group (range)
Starostna skupina (razpon)
In mice, a murine analogue of rilonacept had no effect on fertility.
Pri miših mišji analog rilonacepta ni vplival na plodnost.
Hold the vial with the solution on a firm surface and wipe the top of the vial with a new alcohol wipe.
Držite vialo z raztopino na čvrsti površini in obrišite vrh viale z novim alkoholnim zložencem.
From a microbiological safety point of view, the product should be used as soon as possible but within 3 hours of reconstitution, because it does not contain a preservative.
S stališča mikrobiološke varnosti je treba zdravilo uporabiti takoj, najpozneje pa 3 ure po rekonstituciji, ker ne vsebuje konzervansa.
An increased incidence of serious infections has been associated with administration of another IL-1 inhibitor, in combination with a TNF inhibitor.
Zvečano incidenco resnih okužb povezujejo z dajanjem drugega zaviralca IL-1, v kombinaciji z zaviralcem TNF.
The subsequent doses are administered as a 2 ml (160 mg of rilonacept) subcutaneous injection once a week.
Poznejše odmerke dajemo v obliki 2-mililitrske (160 mg rilonacepta) subkutane injekcije enkrat na teden.
It is recommended that neutrophil counts be assessed prior to initiating treatment, after 1 to 2 months, and periodically thereafter while receiving Rilonacept Regeneron.
Priporočljivo je določiti koncentracijo nevtrofilcev pred uvedbo zdravljenja, po 1 do 2 mesecih in nato v rednih presledkih med prejemanjem zdravila Rilonacept Regeneron.
Neutropenia (absolute neutrophil count [ANC] < 1.5 x 109/l) has been observed commonly with another medicinal product that inhibits IL-1 used in a patient population (rheumatoid arthritis) other than CAPS.
Nevtropenijo (absolutna koncentracija nevtrofilcev [ANC] < 1,5 x 109/l) so pogosto opazili pri drugih zdravilih, ki zavirajo IL-1 in se uporabljajo pri populaciji bolnikov z drugimi boleznimi (revmatoidni artritis), ne s CAPS.
• The starting dose is 2 injections of 2 millilitres (ml) solution each, given on the same day at 2 different areas of the body.
• Začetni odmerek sta 2 injekciji po 2 mililitra (ml) raztopine, ki vam ju dajo istega dne na 2 različnih mestih na telesu;
If an area is tender or feels hardened, choose another site for injection until the tenderness or “hardening” goes away.
Če je predel občutljiv ali je na otip zatrdel, izberite za injekcijo drugo mesto, dokler občutljivost ali zatrdlina ne izgine.
Then slowly and gently, push in the plunger so that all of the air is pushed through the needle.
Potem pa počasi in previdno potisnite bat tako, da zrak potisnete skozi iglo.
LDPE vials containing 5 ml water for injections Each pack contains:
Viala z vehiklom viale iz LPDE, ki vsebujejo po 5 ml vode za injekcije Eno pakiranje vsebuje:
For convenience, the corresponding dose volume for weekly injection in paediatric patients is presented in Table 1 below.
Zaradi prikladnosti so v spodnji preglednici 1 navedeni ustrezni volumni tedenskih injekcij pri pediatričnih bolnikih.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
C. DRUGI POGOJI IN ZAHTEVE V ZVEZI Z DOVOLJENJEM ZA PROMET Z ZDRAVILOM
In Part B, randomised withdrawal, the incidence of infections were similar in the Rilonacept Regeneron (0%) and the placebo patients (4%).
V delu B, randomizirana odtegnitev, je bila incidenca okužb pri bolnikih z zdravilom Rilonacept Regeneron (0 %) in s placebom (4 %) podobna.
For the full list of excipients, see section 6.1.
Za celotni seznam pomožnih snovi glejte poglavje 6.1.
The MAH shall submit an updated risk management plan (RMP) that adequately describes the additional pharmacovigilance activity of performing an embryo-foetal developmental toxicity study in cynomolgus monkeys to further investigate the
Imetnik dovoljenja za promet z zdravilom bo predložil posodobljen načrt za obvladovanje tveganja (RMP), ki zadostno opiše dodatno farmakovigilančno dejavnost pri izvajanju študije toksičnosti za razvoj zarodka/plodu na makakih za nadaljnje preučevanje morebitnega tveganja za okvare pri plodu.
Turn the syringe so that the needle is facing straight up.
Obrnite brizgo, tako da igla gleda naravnost navzgor.
If you use more Rilonacept Regeneron than you should If you accidentally inject more Rilonacept Regeneron than the recommended dose, you should contact your doctor right away.
Če ste uporabili večji odmerek zdravila Rilonacept Regeneron, kot bi smeli Če ste pomotoma injicirali več zdravila Rilonacept Regeneron, kot je priporočeni odmerek, se takoj obrnite na svojega zdravnika.
Dose volume (ml)
Volumen odmerka (ml)
The ISRs included erythema, swelling, pruritus, and bruising.
ISR so vključevale eritem, oteklino, pruritus in modrice.
• Allergic reaction
• alergijska reakcija;
If you do touch the rubber stopper, clean it with a fresh alcohol wipe.
Če se dotaknete gumijastega zamaška, ga očistite z neuporabljenim alkoholnim robčkom.
- Solvent is provided in a 5 ml transparent plastic vial containing 5 ml water for injections.
Vehikel je na voljo v 5-mililitrski viali iz prozorne plastike, ki vsebuje 5 ml vode za injekcije.
Check to make sure that you have the amount of medicine prescribed by your doctor in the syringe.
Prepričajte se, da imate v brizgi toliko zdravila, kot vam ga je predpisal zdravnik.
Do not throw away vials, needles, or syringes in the household rubbish.
Ne zavrzite vial, igel ali brizg skupaj z gospodinjskimi odpadki.
• an infection;
• okužbo;
Decreases in β-estradiol levels were seen in the treated groups, the significance of this finding is unknown.
Pri skupini, ki je prejemala rilonacept, so ugotovili znižanje koncentracije β-estradiola, pomembnost te ugotovitve je neznana.
With the other hand, take the syringe with the sterile water (solvent) and slowly insert the needle straight down through the centre of the rubber stopper of the Rilonacept Regeneron powder vial.
Z drugo roko vzemite brizgo s sterilno vodo (vehiklom) in počasi zabodite iglo naravnost navzdol skozi sredino gumijastega zamaška viale s praškom zdravila Rilonacept Regeneron.
p-value for within group comparison of change from Baseline
Vrednost p za primerjavo spremembe od izhodišča znotraj skupine
• Reactions at injection site (such as redness, swelling, itching, and bruising at the injection site)
• Reakcije na mestu injiciranja (kot so rdečina, oteklina, srbenje in modrica na mestu injekcije);
Rilonacept Regeneron should be discontinued if a patient develops a serious infection.
Zdravilo Rilonacept Regeneron moramo ukiniti, če se pri bolniku razvije resna okužba.
The combination of Rilonacept Regeneron with TNF inhibitors has not been evaluated in clinical studies.
Kombinacije zdravila Rilonacept Regeneron z zaviralci TNF v kliničnih študijah niso proučili.
While holding the syringe at eye level, slowly pull the syringe plunger back to the 2.5-ml line so that the sterile water (solvent) moves from the vial into the syringe (see Figure 3).
Medtem ko držite brizgo v višini oči, počasi povlecite bat brizge nazaj do črte 2,5 ml, tako da se sterilna voda (vehikel) prenese iz viale v injekcijsko brizgo (glejte sliko 3).
Do not use Rilonacept Regeneron after the expiry date.
Zdravila Rilonacept Regeneron ne uporabljajte po datumu izteka roka uporabnosti.
The concomitant administration of Rilonacept Regeneron with any TNF inhibitor is not recommended (see section 4.4), because an increased incidence of serious infections has been associated with administration of another IL-1 blocker in combination with TNF inhibitors.
Sočasna uporaba zdravila Rilonacept Regeneron s katerimkoli zaviralcem TNF ni priporočljiva (glejte poglavje 4.4), ker zvečano incidenco resnih okužb povezujejo z uporabo drugega blokatorja IL-1 v kombinaciji z zaviralci TNF.
The mean number of symptomatic “flare” days (defined as a day in which the mean symptom score reported on the patient diary was greater than 3) during the 21-day pre-treatment baseline period and the on-treatment endpoint period, in Part A, decreased from 8.6 at baseline to 0.1 at endpoint for the group on rilonacept, compared to a change from 6.2 to 5.0 for the placebo group (p<0.0001 vs. placebo).
Povprečno število dni s simptomatskimi “izbruhi” (definiranih kot dnevi, ko je bil povprečni izid simptomov, o katerem je poročal bolnikov dnevnik, večji od 3), se je med 21-dnevnim izhodiščnim obdobjem pred zdravljenjem in obdobjem končnega stanja med zdravljenjem v delu A zmanjšal z 8,6 ob izhodišču na 0,1 ob zaključku pri skupini na rilonaceptu, v primerjavi s spremembo s 6,2 na 5,0 pri skupini s placebom (p<0,0001 proti placebu).
Adolescents (aged 12 to 17 years old)
Mladostniki (stari 12 do 17 let)
Place the capped needle on a clean surface.
Položite iglo s pokrovčkom na čisto površino.
For subsequent self-administration by patients, appropriate instruction in proper injection technique should be provided and ability to apply that technique ascertained.
Da si bodo bolniki pozneje lahko zdravilo samoinjicirali, morajo dobiti ustrezna navodila za pravilno tehniko injiciranja, zdravnik pa mora preveriti njihovo sposobnost za uporabo te tehnike.
AUC (day mg/l)
AUC (dan mg/l)
p-value for within group comparison of change from Baseline p< 0.0001 NS
Vrednost p za primerjavo spremembe od izhodišča znotraj skupine p< 0,0001 NS
Rilonacept is a dimeric fusion protein consisting of the ligand-binding domains of the extracellular portions of the human type I interleukin-1 receptor (IL-1RI) and IL-1 receptor accessory protein (IL-1RAcP) linked in-line to the Fc portion of human IgG1.
Rilonacept je dimerna fuzijska beljakovina, ki jo sestavljajo območja ekstracelularnih delov receptorja za interlevkin-1 (IL-1RI) in pomožne beljakovine receptorja za IL-1 (IL-1RAcP) humanega tipa I, ki vežejo ligande, zaporedno vezanih na Fc del humanega IgG1.
• 1 gauze pad
• 1 kos gaze
• The unknown safety of Rilonacept Regeneron in pregnant and lactating women, thus the need for physicians to discuss this risk with patients if they become or plan to become pregnant;
• o dejstvu, da ni znano, ali je zdravilo Rilonacept Regeneron za nosečnice in doječe ženske varno ali ne, zaradi česar je potrebno, da se zdravniki pogovorijo o tem tveganju z bolnicami,
Mean levels of C reactive protein (CRP) were significantly decreased versus baseline for the rilonacepttreated patients, while there was no change for those on placebo.
Povprečne koncentracije C-reaktivnega proteina (CRP) so se pri bolnikih, zdravljenih z rilonaceptom, signifikantno znižale od izhodišča, medtem ko pri bolnikih na placebu sprememb ni bilo.
Hold the vial in one hand and the syringe in the other hand and carefully turn the vial upside down so that the needle is pointing straight up.
Držite vialo v eni roki, brizgo pa v drugi in jo previdno zasukajte na glavo, tako da igla gleda naravnost navzgor.
Although neutropenia was observed uncommonly in CAPS patients, the numbers studied are small.
Čeprav so pri bolnikih s CAPS občasno opazili nevtropenijo, so proučili malo bolnikov.
During Part A of the pivotal study (see section 5.1), the incidence of patients reporting infections and considered by the investigator as related to treatment was greater with Rilonacept Regeneron (9%) than with placebo (0%).
Med delom A ključne študije (glejte poglavje 5.1) je bila incidenca bolnikov, ki so poročali o okužbah, raziskovalec pa jih je imel za povezane z zdravljenjem, večja pri zdravilu Rilonacept Regeneron (9 %) kot pri placebu (0 %).
The study evaluated the mean symptom score using the change from baseline to the end of treatment.
študiji so ocenjevali povprečni izid simptomov, pri čemer so uporabili spremembo med izhodiščem in koncem zdravljenja.
Keep the vial on a flat surface and slowly insert the needle straight down through the stopper.
Držite vialo na ravni površini in počasi zabodite iglo naravnost navzdol skozi zamašek.