natgillin/translations-raw huggingface dataset:
- 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.
Remove the vial from the syringe. 
Odstranite vialo z brizge.
Do not recycle the container. 
Vsebnika ne smete reciklirati ali uporabiti še enkrat.
One patient in a study of osteoarthritis developed transient neutropenia (absolute neutrophil count < 1 x 109/l) after receiving a very large dose (2000 mg). 
Pri enem bolniku v študiji osteoartritisa se je po prejemu zelo velikega odmerka (2.000 mg) razvila prehodna nevtropenija (absolutna koncentracija nevtrofilcev < 1 x 10
Injections should never be made at sites that are bruised, red, tender, or hard. 
Nikoli ne smete dati injekcije v modrico ali predele, ki so rdeči, občutljivi ali trdi.
Keep the puncture-resistant container out of reach of children. 
Vsebnik za ostre odpadke shranjujte nedosegljiv otrokom.
The impact of treatment with Rilonacept Regeneron on the development of malignancies is not known. 
Vpliv zdravljenja z zdravilom Rilonacept Regeneron na razvoj malignih bolezni ni znan.
4 vials of powder containing 220 mg rilonacept 4 vials of 5 ml solvent 
4 viale praška, ki vsebujejo po 220 mg rilonacepta 4 viale po 5 ml vehikla
If you miss a dose of Rilonacept Regeneron and remember within a few days, inject it as soon as you remember. 
Če ste pozabili uporabiti zdravilo Rilonacept Regeneron Če izpustite odmerek zdravila Rilonacept Regeneron in se spomnite čez nekaj dni, si ga injicirajte, takoj ko se spomnite.
The needle and syringe used for reconstitution with solvent should then be discarded and should not be used for subcutaneous injections. 
Nato iglo in brizgo, ki ste ju uporabili za rekonstitucijo z vehiklom, zavrzite in ju ne uporabite za subkutane injekcije.
Neutropenia was observed commonly in patients with rheumatoid arthritis (not an approved use) who were administered Rilonacept Regeneron subcutaneously in clinical studies. 
Nevtropenijo so pogosto opazili pri bolnikih z revmatoidnim artritisom (to ni odobrena raba), ki so v kliničnih študijah prejeli zdravilo Rilonacept Regeneron subkutano.
• Being unable to sleep (insomnia) 
• nespečnost (insomnija).
Tap the syringe until the air bubbles rise to the top of the syringe. 
Potrkajte po brizgi, da se bodo zračni mehurčki dvignili na vrh brizge.
The concomitant administration of Rilonacept Regeneron with other IL-1 inhibitors has not been studied and is therefore not recommended. 
Sočasne uporabe zdravila Rilonacept Regeneron z drugimi zaviralci IL-1 niso raziskovali in je zato ne priporočajo.
Hold the vial at eye level. 
Držite vialo v višini oči.
Because Rilonacept Regeneron dampens an inflammatory response, vigilance in excluding underlying infection in unwell patients is required. 
Ker zdravilo Rilonacept Regeneron zavira vnetni odziv, je pri bolnikih, ki se ne počutijo dobro, potrebna pozornost pri izključevanju okužbe v ozadju.
• 4 vials of sterile water (solvent) 
• 4 viale sterilne vode (vehikel).
Do not use any vial of Rilonacept Regeneron more than one time. 
Nobene viale zdravila Rilonacept Regeneron ne uporabite več kot enkrat.
If there is more sterile water in syringe, then push the syringe plunger to force out sterile water until the water reaches the 2.3-ml line. 
Če je v injekcijski brizgi več sterilne vode, potisnite bat injekcijske brizge, da iztisnete sterilno vodo, dokler ne sega do oznake za 2,3 ml.
The solution is viscous, clear and colourless to pale yellow. 
Raztopina je viskozna, bistra in brezbarvna do bledo rumena.
If there is discolouration or particulate matter in the solution, the product must not be used. 
Če je raztopina obarvana ali vsebuje delce, je ne smete uporabiti.
With your free hand hold the syringe near its base. 
S prosto roko primite brizgo blizu spodnjega dela.
4 vials of powder for solution for injection 4 vials of solvent 
4 viale praška za raztopino za injiciranje 4 viale vehikla
In an open-label extension study, one patient developed bacterial meningitis and died. 
V odprti podaljšani študiji se je pri enem bolniku razvil bakterijski meningitis, bolnik je umrl.
Cholesterol and lipid levels may be reduced in patients with chronic inflammation. 
Pri bolnikih s kroničnim vnetjem se lahko koncentracija holesterola in lipidov zniža.
Patients treated with rilonacept experienced an 84% reduction in the mean symptom score in Part A compared to 13% for placebo-treated patients (p< 0.0001). 
Pri bolnikih, zdravljenih z rilonaceptom, so se povprečni izidi simptomov v delu A zmanjšali za 84 %, pri bolnikih, ki so prejemali placebo, pa za 13 % (p< 0,0001).
Rilonacept binds to and blocks the activity of the cytokine IL-1 and binds both IL-1β and IL-1α, which are the primary pro-inflammatory cytokines implicated in many inflammatory diseases. 
Rilonacept se veže na citokin IL-1 in blokira njegovo aktivnost, veže pa tudi tako IL-1β kot IL-1α, ki sta primarna citokina, ki pospešujeta vnetje in sta vpletena v številne vnetne bolezni.
Patients with CAPS treated with Rilonacept Regeneron experienced mean increases from baseline for total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides of 19 mg/dl, 2 mg/dl, 10 mg/dl, and 57 mg/dl respectively after 6 weeks of open-label therapy. 
Pri bolnikih s CAPS, zdravljenih z zdravilom Rilonacept Regeneron, se je po 6 tednih odprtega zdravljenja celotni holesterol povprečno zvišal od izhodišča za 19 mg/dl, HDL holesterol za 2 mg/dl, LDL holesterol za 10 mg/dl in trigliceridi za 57 mg/dl.
Injection site reactions, including erythema, bruising, pruritus, swelling, inflammation, pain, dermatitis, oedema, urticaria, vesicles very common 
Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja, vključno z eritemom, podplutbami, pruritusom, oteklino, vnetjem, bolečino, dermatitisom, edemi, koprivnico, mehurčki zelo pogosti utrujenost pogosti
Hold the barrel of the syringe with one hand and twist the 27-gauge needle onto the tip of the syringe with the other hand until it fits snugly (see Figure 4). 
Z eno roko držite brizgo, z drugo pa privijajte iglo kalibra 27 na vrh brizge, dokler se tesno ne prilega (glejte sliko 4).
Do not try to put the needle cover back on the needle. 
Ne poskušajte natakniti pokrovčka igle nazaj na iglo.
Keep the tip of the needle in the liquid and slowly pull back on the plunger to the mark on the syringe that matches the amount of medicine prescribed by your doctor (see Figure 11). 
Pazite, da bo konica igle v tekočini, in počasi povlecite bat nazaj do oznake na brizgi, ki je enaka količini zdravila, ki vam ga je predpisal zdravnik (glejte sliko 11).
No data are available on the use of Rilonacept Regeneron in children with CAPS under 12 years of age, therefore it is not recommended in this paediatric age group. 
O uporabi zdravila Rilonacept Regeneron pri otrocih s CAPS, mlajših od 12 let, podatkov ni na voljo, zato ga v tej starostni skupini otrok ne priporočajo.
Although hypersensitivity reactions related to treatment with Rilonacept Regeneron were not seen in the initial clinical program, if a hypersensitivity reaction occurs, administration should be stopped immediately and permanently, and appropriate therapy initiated. 
Čeprav v začetnem kliničnem programu niso opazili preobčutljivostnih reakcij, povezanih z zdravljenjem z zdravilom Rilonacept Regeneron, moramo takoj in za stalno prekiniti uporabo in uvesti ustrezno zdravljenje, če se pojavi preobčutljivostna reakcija.
Maximum weekly doses of up to 320 mg have been administered subcutaneously for up to approximately 2 years or more in a small number of patients with CAPS and up to 6 months in patients with RA in clinical studies without evidence of dose-limiting toxicities. 
V kliničnih študijah so subkutano dajali največje tedenske odmerke do 320 mg majhnemu številu bolnikov s CAPS približno 2 leti ali več in bolnikom z RA do 6 mesecev brez znakov toksičnosti, ki bi omejevali odmerjanje.
Use a quick “dart like” motion to insert the needle straight into the skin (90° angle) (see Figure 13a). 
S hitrim in kratkim gibom zapičite iglo naravnost v kožo (pod kotom 90°) (glejte sliko 13a).
Rilonacept Regeneron is used to treat adults and adolescents aged 12 years and older with severe symptoms of Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS). 
Zdravilo Rilonacept Regeneron se uporablja za zdravljenje odraslih in mladostnikov, starih 12 let in več, s težkimi simptomi familiarnega avtoinflamatornega sindroma zaradi mraza (FCAS) in Muckle-Wellsovega sindroma (MWS).
After reconstitution, if necessary the product may be kept at room temperature, but should be used within three hours of reconstitution because it does not contain a preservative. 
Če je potrebno, lahko po rekonstituciji zdravilo hranite pri sobni temperaturi, a ga morate porabiti v treh urah po rekonstituciji, ker ne vsebuje konzervansa.
Do not throw any medicines via wastewater or household waste. 
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Attach the needle securely to the syringe without removing the needle cover. 
Iglo pritrdite na injekcijsko brizgo, ne da bi ob tem odstranili pokrovček za iglo.
The safety of Rilonacept Regeneron in breast-feeding women is unknown. 
Varnost zdravila Rilonacept Regeneron pri doječih ženskah ni znana.
The solvent is water for injections. 
Vehikel je voda za injekcije.
If someone else is giving you the injection, the upper arms may also be used for injection (see Figure 12): (Do not inject within a 5-cm area around the navel.) 
Če vam daje injekcijo kdo drug, lahko za injekcijo uporabi tudi nadlaket (glejte sliko 12):
Throw away the vials, used syringes and needles in the punctureresistant container. 
Zavrzite viale, uporabljene brizge in igle v vsebnik za ostre odpadke.
Weight range (kg) 
Razpon telesne mase (kg)
It is stated on the vial label and carton after “EXP”. 
Naveden je na oznaki viale in škatli za »Uporabno do«.
• Do not reuse needles or syringes. 
• Igel in injekcijskih brizg ne uporabite ponovno.
Very common side effects (affects 1 or more users in 10) 
Zelo pogosti neželeni učinki (pojavijo se pri 1 ali več bolnikih od 10 bolnikov)
In Part B, mean symptom scores increased more in patients withdrawn to placebo compared to patients who remained on rilonacept. 
V delu B so se povprečni izidi simptomov bolj zvečali pri bolnikih, ki so po odtegnitvi rilonacepta prejemali placebo, kot pri bolnikih, ki so ostali na rilonaceptu.
- If you have further questions, ask your doctor or pharmacist. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
• one used for adding the sterile water (solvent) to the Rilonacept Regeneron powder 
• ena se uporabi za dodajanje sterilne vode (vehikla) prašku zdravila Rilonacept Regeneron
During the initial placebo-controlled portion of the pivotal trial, mean values increased for haemoglobin and decreased for neutrophils and platelets in the patients treated with Rilonacept Regeneron. 
Med začetnim delom ključnega preskušanja, kontroliranim s placebom, so pri bolnikih, zdravljenih z zdravilom Rilonacept Regeneron, narasle srednje vrednosti hemoglobina, zmanjšale pa so se vrednosti nevtrofilcev in trombocitov.
Treatment should be initiated with a loading dose of 4.4 mg/kg, up to a maximum of 320 mg. Dosing should be continued with a once-weekly injection of 2.2 mg/kg, up to a maximum of 160 mg (see Table 1). 
Zdravljenje naj se uvede s polnitvenim odmerkom 4,4 mg/kg, do največ 320 mg. Odmerjanje naj se nadaljuje z injekcijo 2,2 mg/kg enkrat na teden, do največ 160 mg (glejte preglednico 1).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Rilonacept Regeneron 
IME ZDRAVILA IN POT(I) UPORABE vehikel za zdravilo Rilonacept Regeneron
OTHER Water for injections. 
DRUGI PODATKI Voda za injekcije.
Do not inject Rilonacept Regeneron more frequently than once weekly. 
Zdravila Rilonacept Regeneron ne injicirajte pogosteje kot enkrat na teden.
- Rilonacept Regeneron is provided as a powder for solution for injection in a glass vial. 
Zdravilo Rilonacept Regeneron je na voljo kot prašek za raztopino za injiciranje v stekleni viali.
The formation of CYP450 enzymes is suppressed by increased levels of cytokines during chronic inflammation. 
Zvišane ravni citokinov med kroničnim vnetjem zavirajo nastajanje encimov s CYP450.
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonski škatlici in etiketi viale za Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
With the needle cover on, pull back the plunger on the syringe to the mark that is equal to the volume of the solution that your doctor has prescribed for you to inject, filling the syringe with air (see Figure 9). 
Medtem ko je pokrovček še nameščen, bat brizge povlecite nazaj do oznake, ki ustreza prostornini raztopine, ki vam jo je predpisal zdravnik, pri čemer brizgo napolnite z zrakom (glejte sliko 9).
Rilonacept Regeneron is injected under the skin (subcutaneously). 
Zdravilo Rilonacept Regeneron se injicira pod kožo (subkutano).
• When new information is received that may impact on the current Safety Specification, 
• kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja;
Set the vial aside. 
Odložite vialo.
• Upper respiratory infection 
• okužbe zgornjih dihal;
Using aseptic technique, the recommended dose volume, up to 2 ml (160 mg) of the solution, should be withdrawn with a new 27 gauge, ½-inch injection needle attached to a new 3 ml syringe for subcutaneous injection. 
Z aseptično metodo povlecite priporočeni volumen odmerka do 2 ml (160 mg) raztopine z novo polpalčno injekcijsko iglo kalibra 27, pritrjeno na novo trimililitrsko brizgo za subkutano injekcijo.
Each vial of powder contains 220 mg rilonacept. 
Ena viala praška vsebuje 220 mg rilonacepta.
• Do not touch the needles or the rubber stopper on the Rilonacept Regeneron vial with your hands. 
• Z rokami se ne dotikajte igel in gumijastega zamaška na viali zdravila Rilonacept Regeneron.
Hold the syringe upright at eye level. 
Brizgo držite pokonci v višini oči.
20 ml clear type I glass vial with rubber stopper and lacquered flip-off aluminium seal containing 220 mg rilonacept. 
Viala s praškom20-mililitrska viala iz prozornega stekla tipa I z gumijastim zamaškom in lakirano aluminijasto zaporko (tipa “flip-off”), ki vsebuje 220 mg rilonacepta.
INSTRUCTIONS FOR USE OF RILONACEPT REGENERON POWDER FOR SOLUTION FOR INJECTION 
NAVODILA ZA UPORABO ZDRAVILA RILONACEPT REGENERON PRAŠEK ZA RAZTOPINO ZA INJICIRANJE
For paediatric patients, the dose is delivered as one or two (for loading dose) subcutaneous injections with a maximum single-injection volume of 2 ml. 
Otrokom dajemo odmerek v obliki ene ali dveh (za polnitveni odmerek) subkutanih injekcij, pri čemer največji volumen ene injekcije ne sme preseči 2 ml.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 220 mg of rilonacept. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala praška vsebuje 220 mg rilonacepta.
What you need to know before you use Rilonacept Regeneron 
Kaj morate vedeti, preden boste uporabili zdravilo Rilonacept Regeneron
Rilonacept Regeneron is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged 12 years and older. 
Zdravilo Rilonacept Regeneron je indicirano za zdravljenje s kriopirinom povezanih periodičnih sindromov (CAPS - Cryopyrin-Associated Periodic Syndromes) s hudimi simptomi, vključno s familiarnim avtoinflamatornim sindromom zaradi mraza (FCAS - Familial Cold Autoinflammatory Syndrome) in Muckle-Wellsovim sindromom (MWS), pri odraslih in otrocih, starih 12 let ali več.
Open the wrapper that contains a 27-gauge needle by pulling apart the tabs. 
Odprite ovoj, ki vsebuje iglo kalibra 27, tako da s potegom ločite označena dela.
• The need to measure neutrophil counts prior to initiating treatment, after 1 to 2 months and periodically thereafter while receiving Rilonacept Regeneron as treatment with Rilonacept 
• o potrebi, da določijo koncentracijo nevtrofilcev pred uvedbo zdravljenja, po 1 do 2 mesecih in nato v rednih presledkih, vse dokler bolnik prejema zdravilo Rilonacept Regeneron, ker se zdravljenje z zdravilom Rilonacept Regeneron pri bolnikih z nevtropenijo ne sme uvesti;
The 2.3 ml of solvent should be withdrawn from the solvent vial attached directly to a 3 ml syringe and then injected into the powder vial for reconstitution using the 27 gauge, ½-inch needle (to obtain a final reconstitution volume of 2.75 ml). 
2,3 ml vehikla povlecite iz viale z vehiklom, ki je neposredno priložena trimililitrski brizgi, in jo nato s polpalčno iglo kalibra 27 injicirajte v vialo s praškom za rekonstitucijo (da boste dobili končni rekonstituirani volumen 2,75 ml).
Ask your doctor any questions that you have about rotating injection sites. 
Vsa vprašanja, ki jih imate o menjavi mest injiciranja, zastavite zdravniku.
Within a month following the notifications of potential risk of foetal defects. 
V enem mesecu po priglasitvah odločbe Komisije.