FrancophonIA/ELRC3.0 huggingface dataset:
English: • 4 vials of sterile water (solvent)
Slovenian: • 4 viale sterilne vode (vehikel).
English: Do not use any vial of Rilonacept Regeneron more than one time.
Slovenian: Nobene viale zdravila Rilonacept Regeneron ne uporabite več kot enkrat.
English: 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.
Slovenian: 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.
English: The solution is viscous, clear and colourless to pale yellow.
Slovenian: Raztopina je viskozna, bistra in brezbarvna do bledo rumena.
English: If there is discolouration or particulate matter in the solution, the product must not be used.
Slovenian: Če je raztopina obarvana ali vsebuje delce, je ne smete uporabiti.
English: With your free hand hold the syringe near its base.
Slovenian: S prosto roko primite brizgo blizu spodnjega dela.
English: 4 vials of powder for solution for injection 4 vials of solvent
Slovenian: 4 viale praška za raztopino za injiciranje 4 viale vehikla
English: In an open-label extension study, one patient developed bacterial meningitis and died.
Slovenian: V odprti podaljšani študiji se je pri enem bolniku razvil bakterijski meningitis, bolnik je umrl.
English: Cholesterol and lipid levels may be reduced in patients with chronic inflammation.
Slovenian: Pri bolnikih s kroničnim vnetjem se lahko koncentracija holesterola in lipidov zniža.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Injection site reactions, including erythema, bruising, pruritus, swelling, inflammation, pain, dermatitis, oedema, urticaria, vesicles very common
Slovenian: 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
English: 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).
Slovenian: Z eno roko držite brizgo, z drugo pa privijajte iglo kalibra 27 na vrh brizge, dokler se tesno ne prilega (glejte sliko 4).
English: Do not try to put the needle cover back on the needle.
Slovenian: Ne poskušajte natakniti pokrovčka igle nazaj na iglo.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Use a quick “dart like” motion to insert the needle straight into the skin (90° angle) (see Figure 13a).
Slovenian: S hitrim in kratkim gibom zapičite iglo naravnost v kožo (pod kotom 90°) (glejte sliko 13a).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Če je potrebno, lahko po rekonstituciji zdravilo hranite pri sobni temperaturi, a ga morate porabiti v treh urah po rekonstituciji, ker ne vsebuje konzervansa.
English: Do not throw any medicines via wastewater or household waste.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: Attach the needle securely to the syringe without removing the needle cover.
Slovenian: Iglo pritrdite na injekcijsko brizgo, ne da bi ob tem odstranili pokrovček za iglo.
English: The safety of Rilonacept Regeneron in breast-feeding women is unknown.
Slovenian: Varnost zdravila Rilonacept Regeneron pri doječih ženskah ni znana.
English: The solvent is water for injections.
Slovenian: Vehikel je voda za injekcije.
English: 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.)
Slovenian: Če vam daje injekcijo kdo drug, lahko za injekcijo uporabi tudi nadlaket (glejte sliko 12):
English: Throw away the vials, used syringes and needles in the punctureresistant container.
Slovenian: Zavrzite viale, uporabljene brizge in igle v vsebnik za ostre odpadke.
English: Weight range (kg)
Slovenian: Razpon telesne mase (kg)
English: It is stated on the vial label and carton after “EXP”.
Slovenian: Naveden je na oznaki viale in škatli za »Uporabno do«.
English: • Do not reuse needles or syringes.
Slovenian: • Igel in injekcijskih brizg ne uporabite ponovno.
English: Very common side effects (affects 1 or more users in 10)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se pri 1 ali več bolnikih od 10 bolnikov)
English: In Part B, mean symptom scores increased more in patients withdrawn to placebo compared to patients who remained on rilonacept.
Slovenian: 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.
English: - If you have further questions, ask your doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: • one used for adding the sterile water (solvent) to the Rilonacept Regeneron powder
Slovenian: • ena se uporabi za dodajanje sterilne vode (vehikla) prašku zdravila Rilonacept Regeneron
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Rilonacept Regeneron
Slovenian: IME ZDRAVILA IN POT(I) UPORABE vehikel za zdravilo Rilonacept Regeneron
English: OTHER Water for injections.
Slovenian: DRUGI PODATKI Voda za injekcije.
English: Do not inject Rilonacept Regeneron more frequently than once weekly.
Slovenian: Zdravila Rilonacept Regeneron ne injicirajte pogosteje kot enkrat na teden.
English: - Rilonacept Regeneron is provided as a powder for solution for injection in a glass vial.
Slovenian: Zdravilo Rilonacept Regeneron je na voljo kot prašek za raztopino za injiciranje v stekleni viali.
English: The formation of CYP450 enzymes is suppressed by increased levels of cytokines during chronic inflammation.
Slovenian: Zvišane ravni citokinov med kroničnim vnetjem zavirajo nastajanje encimov s CYP450.
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Rilonacept Regeneron is injected under the skin (subcutaneously).
Slovenian: Zdravilo Rilonacept Regeneron se injicira pod kožo (subkutano).
English: • When new information is received that may impact on the current Safety Specification,
Slovenian: • 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;
English: Set the vial aside.
Slovenian: Odložite vialo.
English: • Upper respiratory infection
Slovenian: • okužbe zgornjih dihal;
English: 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.
Slovenian: 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.
English: Each vial of powder contains 220 mg rilonacept.
Slovenian: Ena viala praška vsebuje 220 mg rilonacepta.
English: • Do not touch the needles or the rubber stopper on the Rilonacept Regeneron vial with your hands.
Slovenian: • Z rokami se ne dotikajte igel in gumijastega zamaška na viali zdravila Rilonacept Regeneron.
English: Hold the syringe upright at eye level.
Slovenian: Brizgo držite pokonci v višini oči.
English: 20 ml clear type I glass vial with rubber stopper and lacquered flip-off aluminium seal containing 220 mg rilonacept.
Slovenian: 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.
English: INSTRUCTIONS FOR USE OF RILONACEPT REGENERON POWDER FOR SOLUTION FOR INJECTION
Slovenian: NAVODILA ZA UPORABO ZDRAVILA RILONACEPT REGENERON PRAŠEK ZA RAZTOPINO ZA INJICIRANJE
English: 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.
Slovenian: Otrokom dajemo odmerek v obliki ene ali dveh (za polnitveni odmerek) subkutanih injekcij, pri čemer največji volumen ene injekcije ne sme preseči 2 ml.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 220 mg of rilonacept.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala praška vsebuje 220 mg rilonacepta.
English: What you need to know before you use Rilonacept Regeneron
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Rilonacept Regeneron
English: 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.
Slovenian: 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.
English: Open the wrapper that contains a 27-gauge needle by pulling apart the tabs.
Slovenian: Odprite ovoj, ki vsebuje iglo kalibra 27, tako da s potegom ločite označena dela.
English: • 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
Slovenian: • 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;
English: 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).
Slovenian: 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).
English: Ask your doctor any questions that you have about rotating injection sites.
Slovenian: Vsa vprašanja, ki jih imate o menjavi mest injiciranja, zastavite zdravniku.
English: Within a month following the notifications of potential risk of foetal defects.
Slovenian: V enem mesecu po priglasitvah odločbe Komisije.
English: Bronchitis; gastroenteritis; viral infections; skin, eye and ear infections; pneumonia Bacterial meningitis
Slovenian: Infekcijske in parazitske bolezni okužba zgornjih dihal; sinuzitis zelo pogosti bronhitis, gastroenteritis, virusne okužbe; okužbe kože, oči in očes; pljučnica pogosti bakterijski meningitis občasen
English: • 2 sterile, 3-ml disposable syringes
Slovenian: • 2 sterilni trimililitrski brizgi za enkratno uporabo
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated-dose toxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
English: What Rilonacept Regeneron is and what it is used for
Slovenian: Kaj je zdravilo Rilonacept Regeneron in za kaj ga uporabljamo
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Navodila za rekonstitucijo
English: ADRs to Rilonacept Regeneron reported during the Phase 2/3 program in a total of 109 patients, some treated for longer than 2 years, are listed below using the following categories of frequency: very common (≥1/10); common (≥ 1/100 to <1/10), uncommon (≥1/1000 to <1/100).
Slovenian: Uporabili smo naslednje kategorije pogostnosti: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100).
English: • Stomach/Intestinal infection
Slovenian: • okužba želodca/črevesa;
English: No data are available on either the effects of live vaccination or the secondary transmission of infection by live vaccines in patients receiving Rilonacept Regeneron.
Slovenian: Pri bolnikih, ki prejemajo zdravilo Rilonacept Regeneron, ni na voljo nikakršnih podatkov niti o učinkih cepljenja z živim cepivom niti o sekundarnem prenosu okužbe z živimi cepivi.
English: Sites for subcutaneous injection, such as the abdomen, thigh, or upper arm, should be rotated.
Slovenian: Mesta za subkutano injekcijo, na primer trebuh, stegno ali nadlaket, morate menjavati.
English: Do not use Rilonacept Regeneron:
Slovenian: Ne uporabljajte zdravila Rilonacept Regeneron:
English: Results of a single-dose study in patients with end-stage renal disease (ESRD) indicate that the rate of elimination of rilonacept was not decreased.
Slovenian: Rezultati študije enkratnih odmerkov pri bolnikih s končno ledvično odpovedjo (ESRD) kažejo, da se hitrost odstranjevanja rilonacepta iz telesa ni zmanjšala, zato velja eliminacija rilonacepta skozi ledvici za manj pomembno pot za očistek.
English: You must tell your doctor right away if any of the following serious side effects occur while you are using Rilonacept Regeneron:
Slovenian: Takoj morate povedati svojemu zdravniku, če se med jemanjem zdravila Rilonacept Regeneron pojavi kateri od naslednjih resnih neželenih učinkov:
English: Uncommon side effects (affects 1 to up to 10 users in 1,000)
Slovenian: Občasni neželeni učinki (pojavijo se pri od 1 do 10 bolnikih od 1.000 bolnikov)
English: Reconstitution and administration instructions
Slovenian: Navodila za rekonstitucijo in uporabo
English: No dose adjustment is needed in patients with renal impairment.
Slovenian: Pri bolnikih z ledvično okvaro ni potrebno prilagajanje odmerjanja.
English: • 8 sterile, 3-ml disposable syringes
Slovenian: • 8 sterilnih 3-mililitrskih injekcijskih brizg za enkratno uporabo;
English: Attach the exposed top of the sterile water vial to the top of a syringe by twisting the syringe onto the vial of sterile water (solvent) (see Figure 2).
Slovenian: Pritrdite razkriti vrh viale s sterilno vodo na vrh brizge, tako da privijete brizgo na vialo s sterilno vodo (vehiklom) (glejte sliko 2).
English: Rilonacept Regeneron is intended for subcutaneous use.
Slovenian: Zdravilo Rilonacept Regeneron je namenjeno za subkutno uporabo.
English: Table 1: Rilonacept Regeneron dose volume (after reconstitution) by body weight for paediatric patients, aged 12-17 years
Slovenian: Preglednica 1: Volumen odmerka (po rekonstituciji) zdravila Rilonacept Regeneron glede na telesno maso pri otrocih, starih 12-17 let
English: You should tell your doctor if you have:
Slovenian: Če imate kaj od naslednjega, povejte zdravniku:
English: • 1 puncture-resistant container for disposal of used needles, syringes and vials
Slovenian: • 1 vsebnik za odstranjevanje rabljenih igel, brizg in vial, odporen proti prebadanju
English: The average trough levels of rilonacept were approximately 24 µg/ml at steady state following weekly subcutaneous doses of 160 mg for up to 48 weeks in patients with CAPS.
Slovenian: V stanju ravnovesja po vsakotedenskih subkutanih odmerkih po 160 mg do 48 tednov so bile pri bolnikih s CAPS povprečne minimalne koncentracije rilonacepta približno 24 µg/ml.
English: Headache Dizziness
Slovenian: Okvare ledvic
English: • 1 vial of sterile water (solvent)
Slovenian: • 1 vialo sterilne vode (vehikla)
English: Prior to injection, the reconstituted solution should be carefully inspected for any discolouration or particulate matter.
Slovenian: Pred injiciranjem morate rekonstituirano raztopino skrbno pregledati, ali ni obarvana in ali niso prisotni delci.
English: • Physician information
Slovenian: • informacije za zdravnike,
English: Clean the area in a circular motion with a new alcohol wipe.
Slovenian: Predel očistite, tako da ga s krožnim gibom obrišete z novim alkoholnim zložencem.
English: No dose adjustment is required in patients with mild, moderate, or severe renal impairment, or end stage renal disease.
Slovenian: Pri bolnikih z blago, zmerno ali težko ledvično okvaro ali končno ledvično odpovedjo ni potrebno prilagajanje odmerka.
English: Carefully turn the vial upside down.
Slovenian: Previdno potegnite bat navzven.
English: Paediatric population (up to 12 years old)
Slovenian: Otroci (stari do 12 let)
English: • Viral infection
Slovenian: • Virusna okužba;
English: • A puncture-resistant container for disposal of used needles, syringes, and vials
Slovenian: • vsebnik, odporen za vbode, za odstranjevanje uporabljenih igel, injekcijskih brizg in vial.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Table 3: Mean Symptom Scores in Adults (age 18 and older)
Slovenian: Preglednica 3: Povprečni izidi simptomov pri odraslih (starih najmanj 18 let) Del A Placebo (n=24)
English: STEP 1: Setting up for an injection
Slovenian: KORAK 1: Priprava na injiciranje
English: If you have questions, contact your doctor, nurse, or pharmacist.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom, z medicinsko sestro ali s farmacevtom.
English: Push the syringe plunger down all the way so that the sterile water (solvent) in the syringe flows into the vial (see Figure 7).
Slovenian: Bat brizge potisnite navzdol, da se sterilna voda (vehikel) pretoči v vialo (glejte sliko 7).
English: The MAH shall provide updates on the recruitment rates and any intermediary results with the PSURs.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v PSUR vključiti posodobitve o deležu vključenih preskušancev in kakršne koli vmesne rezultate.
English: General guidelines when giving a Rilonacept Regeneron injection:
Slovenian: Splošna navodila pri injiciranju zdravila Rilonacept Regeneron:
English: Table 2: Adverse reactions with Rilonacept Regeneron in CAPS patients MedDRA
Slovenian: Preglednica 2: Neželeni učinki pri zdravilu Rilonacept Regeneron pri bolnikih s CAPS Organski sistem po
English: Reduction from Baseline
Slovenian: Zmanjšanje od izhodišča
English: • 2 sterile, disposable needles (27-gauge, ½-inch)
Slovenian: • 2 sterilni igli za enkratno uporabo (27-G, pol palca):
English: With the other hand gently pinch a fold of skin around the site that you cleaned for injection.
Slovenian: Z drugo roko na predelu kože, ki ste ga očistili, nežno naredite kožno gubo za injiciranje.
English: Women should use effective contraceptives during treatment with Rilonacept Regeneron and for up to 6 weeks after the last dose.
Slovenian: Med zdravljenjem z zdravilom Rilonacept Regeneron in še do 6 tednov po zadnjem odmerku morajo ženske uporabljati učinkovita kontracepcijska sredstva.
English: STEP 6: Giving the injection Rilonacept Regeneron is injected into the tissue directly below the layers of skin.
Slovenian: Zdravilo Rilonacept Regeneron se injicira v tkivo neposredno pod plastmi kože.
English: • Patient Alert Card
Slovenian: • opozorilne kartice za bolnike.