FrancophonIA/ELRC3.0 huggingface dataset:
English: Injection site reactions, including erythema, bruising, pruritus, swelling, inflammation, pain, dermatitis, oedema, urticaria, vesicles very common
Maltese: Reazzjonijiet fis-sit tal-injezzjoni, li jinkludu eritema, tbenġil, ħakk, nefħa, infjammazzjoni, uġigħ, dermatite, edema, urtikarja, infafet.
English: Thus it is expected that for a molecule that binds to IL-1, such as rilonacept, the formation of CYP450 enzymes could be normalized.
Maltese: Għaldaqstant hu mistenni li għal molekula li teħel ma' IL-1, bħal rilonacept, il-formazzjoni ta' enzimi CYP450 tista' tiġi normalizzata.
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).
Maltese: Rilonacept Regeneron jintuża għall-kura ta' adulti u adolexxenti li għandhom 12-il sena jew iżjed, b'sintomi severi ta' Sindromu ta' Riħ Familjali Awtoinfjammatorju (FCAS) u s-Sindromu ta' Muckle-Wells (MWS).
English: • The starting dose is 4.4 milligrams per kilogram of body weight, up to 320 milligrams (mg), given as one or two injections.
Maltese: • Id-doża inizjali hi ta' 4.4 milligrammi għal kull kilogramm ta' piż tal-ġisem, sa 320 milligrammi
English: 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.
Maltese: Fi studji kliniċi, pazjenti bil-CAPS li jkollhom produzzjoni żejda ta' IL-1β li ma tkunx ikkontrollata, juru respons mgħaġġel għat-terapija b'rilonacept, i.e. parametri tal-laboratorju bħal-livelli ta' proteina reattiva-Ċ (CRP) u amyloid A tas-serum (SAA), lewkoċitosi, u għadd għoli tal-plejtlits, malajr reġgħu lura għan-normal.
English: • 8 sterile, 3-ml disposable syringes
Maltese: • 8 siringi sterili ta' 3 ml
English: Rilonacept Regeneron 80 mg/ml powder and solvent for solution for injection rilonacept
Maltese: Rilonacept Regeneron 80 mg/ml trab u solvent għal soluzzjoni għall-injezzjoni rilonacept
English: Each vial of powder contains 220 mg rilonacept.
Maltese: Kull kunjett fih 220 mg ta' rilonacept.
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.
Maltese: Rilonacept Regeneron hu indikat għall-kura ta' Sindromi Perjodiċi Assoċjati ma' Cryopyrin (CAPS) b'sintomi severi, li jinkludu Sindrome Awtoinfjammatorju ta' Riħ Familjali (FCAS) u s-Sindrome ta' Muckle-Wells (MWS), f'adulti u t-tfal li jkollhom 12-il sena jew iżjed.
English: • Medicines called Tumour Necrosis Factor (TNF) inhibitors (such as etanercept, adalimumab, or infliximab) predominantly used in rheumatoid and autoimmune disease.
Maltese: • Mediċini li jissejħu impedituri tal-Fattur tan-Nekrosi tat-Tumur (bħal etanercept, adalimumab, jew infliximab) li jintużaw prinċipalment għal mard awtoimmuni jew rewmatiku.
English: Common side effects (affects 1 to up to 10 users in 100)
Maltese: Effetti sekondarji komuni (jaffettwaw minn utent 1 sa 10 f'kull 100)
English: Tumour necrosis factor (TNF) inhibitors have been associated with an increased risk of reactivation of latent tuberculosis (TB).
Maltese: Inibituri tal-fattur tan-nekrosi tat-tumur (TNF) kienu assoċjati ma' żieda fir-riskju ta' attivazzjoni millġdid ta' tuberkulosi (TB) moħbija.
English: Rilonacept also binds the endogenous IL-1 receptor antagonist (IL-1ra) but with a lower affinity than IL-1β or IL-1α.
Maltese: Rilonacept jeħel ukoll mal-antagonist endoġeniku ta' riċettur IL-1 (IL-1ra) iżda b'affinità iktar baxxa minn IL-1β jew IL-1α.
English: 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.
Maltese: Fi studju f'pazjenti bil-marda ta' Still fl-adulti, pazjent wieħed żviluppa infezzjoni fil-minkeb b'Mycobacterium intracellulare wara injezzjoni intra-artikulari bi glukokortikojde u espożizzjoni lokali sussegwenti għal sors issuspettat ta' mycobacteria.
English: • 2 sterile, disposable needles (27-gauge, ½-inch)
Maltese: • 2 labar sterili li jintremew wara li jintużaw (qies 27, ½ pulzier)
English: In Part B, randomised withdrawal, the incidence of infections were similar in the Rilonacept Regeneron (0%) and the placebo patients (4%).
Maltese: F'Parti B, irtirar b'għażla każwali, l-inċidenza ta' infezzjonijiet kienet simili f'pazjenti li kienu fuq Rilonacept Regeneron (0%) u fil-pazjenti li kienu fuq il-plaċebo (4%).
English: Rilonacept Regeneron should not be used with TNF inhibitors because of increased risk of serious infections (see section 4.5).
Maltese: Rilonacept Regeneron m'għandux jintuża ma' inibituri ta' TNF minħabba żieda fir-riskju ta' infezzjonijiet serji (ara sezzjoni 4.5).
English: • if you have an active, severe infection.
Maltese: • jekk għandek infezzjoni attiva u severa.
English: See also section 3, “How to inject Rilonacept Regeneron.”
Maltese: Ara wkoll sezzjoni 3, “Kif tinjetta Rilonacept Regeneron.
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.
Maltese: Jekk hemm aktar ilma sterili fis-siringa, imbagħad imbotta s-siringa sabiex tisforza l-ilma sterili sakemm l-ilma jilħaq il-linja ta' 2.3 ml.
English: • 8 sterile, disposable needles (27-gauge, ½-inch)
Maltese: • 8 labar sterili li jintremew wara li jintużaw (daqs 27, ½ pulzier)
English: Rilonacept also led to a significant decrease in serum amyloid A (SAA) versus baseline to levels within the normal range.
Maltese: Rilonacept wassal ukoll għal tnaqqis sinifikanti fl-amyloid A tas-serum (SAA) meta mqabbel mal-linja bażi għal livelli fil-medda normali.
English: • Other medicines that block interleukin-1, such as anakinra or canakinumab.
Maltese: • Mediċini oħrajn li jimblukkaw interleukin-1, bħal anakinra jew canakinumab
English: • The starting dose is 2 injections of 2 millilitres (ml) solution each, given on the same day at 2 different areas of the body.
Maltese: • Id-doża tal-bidu hi ta' 2 injezzjonijiet ta' soluzzjoni ta' 2 ml kull waħda, mogħtija fl-istess jum f'2 siti differenti tal-ġisem.
English: Vaccines
Maltese: FARMAĊEWTIKA
English: This is clinically relevant for CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin).
Maltese: Dan hu klinikament rilevanti għal substrati ta' CYP450 b'indiċi terapewtiku żgħir, fejn id-doża tiġi aġġustata individwalment (eż. warfarin).
English: Twelve additional patients enrolled during the open label extension in which efficacy data were collected, 8 adults with a diagnosis of FCAS and 4 adolescents (13-16 years old), 3 with FCAS and 1 with FCAS/MWS overlap.
Maltese: Tnax-il pazjent addizzjonali rreġistraw matul l-istudju ta' estensjoni tat-tip open label li fih dejta dwar l-effikaċja ġiet miġbura, 8 adulti b'dijanjosi ta' FCAS u 4 adolexxenti (13-16-il sena), 3 b'FCAS u 1 b'FCAS/MWS li jseħħu fl-istess ħin.
English: 30 September
Maltese: 30 ta' Settembru 2012
English: The sterile water should be at the 2.3-ml line (see Figure 6).
Maltese: L-ilma sterili għandu jkun fuq il-linja ta' 2.3 ml (ara Figura 6).
English: Iritis
Maltese: Rimi
English: • Reactions at injection site (such as redness, swelling, itching, and bruising at the injection site)
Maltese: • Reazzjonijiet fis-sit tal-injezzjoni (bħal ħmura, nefħa, ħakk, u tbenġil fis-sit tal-injezzjoni).
English: • 3 alcohol wipes
Maltese: • 3 biċċiet bl-alkoħol
English: 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).
Maltese: 9/l) wara li rċieva doża żviluppa newtropenja temporanja (għadd assolut tan-newtrofili ta' < 1 x 10 kbira ħafna (2,000 mg).
English: 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).
Maltese: Il-medja tan-numru ta' jiem sintomatiċi (definiti bħala jum li fih il-medja tal-punteġġ tas-sintomi rrappurtat fid-djarju tal-pazjent kienet aktar minn 3) matul il-Perijodu tal-linja bażi ta' 21 jum qabel ilkura, f'Parti A, naqset minn 8.6 fil-linja bażi għal 0.1 fil-punt aħħari għall-grupp li kien fuq rilonacept, meta mqabbla ma' bidla minn 6.2 għal 5.0 għall-grupp li kien fuq il-plaċebo (p<0.
English: 4 vials of powder containing 220 mg rilonacept 4 vials of 5 ml solvent
Maltese: 4 kunjetti bit-trab li fih 220 mg ta' rilonacept 4 kunjetti b'5 ml ta' solvent
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).
Maltese: ADRs għal Rilonacept Regeneron rrappurtati matul il-programm ta' Fażi 2/3 f'total ta' 109 pazjenti, x'uħud minnhom ikkurati għal iktar minn sentejn, huma elenkati hawn taħt bl-użu tal-kategoriji ta' frekwenza li ġejjin: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10), mhux komuni (≥1/1000 sa
English: Paediatric population (up to 12 years old)
Maltese: Popolazzjoni pedjatrika (tfal sa 12-il sena)
English: The risk for severe hypersensitivity reactions, which is not uncommon for injectable proteins, cannot be excluded (see section 4.3).
Maltese: Ir-riskju għal reazzjonijiet ta' sensittività eċċessiva, li ma tistax tgħid li mhuwiex komuni għal proteini li jistgħu jiġu injettati, ma jistax jiġi eskluż (ara sezzjoni 4.3).
English: The efficacy was not evaluated in patients without a confirmed NLRP3 gene mutation.
Maltese: L-effikaċja ma kinitx evalwata f'pazjenti mingħajr mutazzjoni kkonfermata fil-ġene NLRP3.
English: Cholesterol and lipid levels may be reduced in patients with chronic inflammation.
Maltese: Il-livelli tal-kolesterol u tal-lipidi jistgħu jitnaqqsu f'pazjenti b'infjammazzjoni kronika.
English: One patient in an open-label study of CAPS died after developing sinusitis and bacterial (Streptococcus pneumoniae) meningitis.
Maltese: Pazjent wieħed fi studju tat-tip open-label dwar il-CAPS miet wara li żviluppa sinusite u meninġite batterjali (Streptococcus pneumoniae).
English: Elderly (65 years old or older)
Maltese: Pazjenti anzjani (65 sena jew iżjed)
English: - The other ingredients in the powder are glycine, arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polyethylene glycol 3350 and sucrose.
Maltese: - Is-sustanzi l-oħra fit-trab huma glycine, arginine hydrochloride, histidine, histidine hychloride monohydrate, polyethylene glycol 3350 u sucrose.
English: Also contains: glycine, arginine hydrochloride, histidine, histidine hydrochloride monohydrate polyethylene glycol 3350, sucrose, and water for injections.
Maltese: Fih ukoll: glycine, arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polyethylene glycol 3350, sucrose, u ilma għall-injezzjonijiet.
English: Headache Dizziness
Maltese: Irite mhux komuni
English: Endpoint Period (Weeks 4 to 6)
Maltese: Perijodu tal-Punt aħħari (Ġimgħat 4 sa 6)
English: In patients with CAPS, the body produces excessive amounts of IL-1 beta.
Maltese: F'pazjenti bilCAPS, il-ġisem jipproduċi ammonti eċċessivi ta' IL-1 beta.
English: Rilonacept Regeneron belongs to a group of medicines called interleukin inhibitors.
Maltese: Rilonacept Regeneron jappartjeni għall-grupp ta' mediċini msejħa inibituri ta' interleukin.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini (EMA): http://www.ema.europa.eu
English: • Inflammation of the eye (iritis)
Maltese: • Infjammazzjoni fl-għajnejn (irite)
English: In mice, a murine analogue of rilonacept had no effect on fertility.
Maltese: Fil-ġrieden, analogu ta' murine ta' rilonacept ma kellu l-ebda effett fuq il-fertilità.
English: 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.
Maltese: Parti A kienet perijodu ta' 6 ġimgħat, randomised, double-blind, ikkontrollat bil-plaċebo biex tevalwa rilonacept f'doża ta' 160 mg kull ġimgħa wara doża qawwija tal-bidu ta' 320 mg.
English: Pre-treatment Baseline Period (Weeks -3 to 0)
Maltese: Perijodu tal-Linja Bażi qabel il-kura (Ġimgħat -3 sa 0)
English: Available data indicate that dose modification is not required based on advanced age.
Maltese: Id-dejta disponibbli tindika li tibdil fid-doża mhuwiex meħtieġ ibbażat fuq età avvanzata.
English: However, treatment with immunosuppressants, including Rilonacept Regeneron, may result in an increase in the risk of malignancies.
Maltese: Madankollu, il-kura b'immunosoppressanti, li jinkludu Rilonacept Regeneron, tista' tirriżulta f'żieda fir-riskju ta' tumuri malinni.
English: Changes in lipid parameters
Maltese: Tibdil fil-parametri tal-lipidi
English: This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
Maltese: Dan ifisser li minħabba li l-marda li qed tbati minnha hija rari, kien impossibbli li tinkiseb informazzjoni kompleta dwar din ilmediċina.
English: Rilonacept Regeneron is injected under the skin (subcutaneously).
Maltese: Rilonacept Regeneron jiġi injettat taħt il-ġilda (b'mod subkutaneju).
English: Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal tibdil fil-profil tal-lipidi tagħhom, u jiġu pprovduti b'kura medika jekk ikun hemm bżonn (ara sezzjoni 4.8).
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.
Maltese: Rilonacept jeħel ma' u jimblokka lattività tas-cytokine IL-1 u jeħel kemm ma' IL-1β u IL-1α, li huma cytokines pro-infjammatorji primarji implikati f'ħafna mard infjammatorju.
English: 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.
Maltese: Fi studju dwar l-effett tossiku fuq is-sistema riproduttiva ta' qabel u ta' wara t-twelid li fih il-ġrieden ingħataw doża taħt il-ġilda, b'analogu ta' murine ta' rilonacept f'dożi ta' 20, 100 jew 200 mg/kg tliet darbiet kull ġimgħa (l-ogħla doża hi ta' madwar 6 darbiet ogħla mid-doża ta' manteniment ta' 160 mg ibbażata fuq l-erja tas-superfiċje tal-ġisem), ma kien hemm l-ebda effetti marbuta mal-kura.
English: By blocking the activity of IL-1 beta, Rilonacept Regeneron leads to an improvement in these symptoms.
Maltese: Billi jimblokka l-attività ta' IL-1 beta, Rilonacept Regeneron iwassal għal titjib f'dawn is-sintomi.
English: Four additional adolescents (12-17 years) all with a diagnosis of FCAS subsequently enrolled in the open label extension where efficacy assessments were not collected.
Maltese: Erba' adolexxenti addizzjonali (12-17-il sena) kollha b'dijanjosi ta' FCAS, sussegwentement irreġistraw fl-istudju ta' estensjoni tat-tip open label, fejn evalwazzjonijiet dwar l-effikaċja ma nġabrux.
English: Table 4: Key symptom scores by age and diagnosis following 24-week open label extension Group
Maltese: Tabella 4: Punteġġi ewlenin tas-sintomi skont l-età u d-dijanjosi wara studju ta' estensjoni tattip open-label ta' 24 ġimgħa
English: Upper respiratory tract infection; sinusitis very common
Maltese: Infezzjoni fin-naħa ta' fuq tal-apparat respiratorju; sinusite komuni ħafna
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.
Maltese: Bl-użu ta' teknika asettika, il-volum rakkomandat tad-doża, sa 2 ml (160 mg) tas-soluzzjoni, għandu jinġibed b'labra ġdida tal-injezzjoni ta' qies 27 , u ½ pulzier, imwaħħla ma' siringa ġdida ta' 3 ml għal injezzjoni taħt il-ġilda.
English: 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.
Maltese: Immedjatament wara Parti A, il-pazjenti għaddew għal Parti B li kienet tikkonsisti f'Perijodu meta l-pazjent ma jkunx jaf x'mediċina qed jingħata ta' 9 ġimgħat, li matulu l-pazjenti kollha rċivew rilonacept 160 mg kull ġimgħa, segwit minn Perijodu double- blind u ta' irttirar b'għażla każwali ta' 9 ġimgħat, li matulu lpazjenti kienu assenjati b'mod każwali jew biex jibqgħu fuq rilonacept 160 mg kull ġimgħa jew biex jirċievu l-plaċebo.
English: The safety and efficacy of rilonacept for the treatment of CAPS, including patients with FCAS, also known as familial cold urticaria syndrome (FCUS), and MWS was demonstrated in a randomised, double-blind, placebo-controlled study with two parts (A and B) conducted sequentially in the same patients.
Maltese: Is-sigurtà u l-effikaċja ta' rilonacept għall-kura tal-CAPS, li jinkludu pazjenti b'FCAS, magħrufa wkoll bħala sindrome tal-urtikarja ta' riħ familjali (FCUS), u MWS kienet murija fi studju randomised, double-blind u kkontrollat bil-plaċebo b'żewġ partijiet (A u B), li sar b'sekwenzja fuq listess pazjenti.
English: No pharmacokinetic data are available in patients with hepatic impairment.
Maltese: M'hemmx dejta farmakokinetika disponibbli għal pazjenti b'indeboliment tal-fwied.
English: During the open-label extension, reductions in mean symptom scores, serum CRP, and serum SAA levels were maintained for up to one year.
Maltese: Matul l-estensjoni tat-tip open label, it-tnaqqis fil-medja tal-punteġġi tas-sintomi, fil-livelli ta' CRP tas-serum, u ta' SAA tas-serum, inżamm sa sena.
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Uġigħ ta' ras komuni ħafna
English: Endpoint Period (Weeks 22 to 24)
Maltese: Perijodu tal-Punt aħħari (Ġimgħat 22 sa 24)
English: Uncommon side effects (affects 1 to up to 10 users in 1,000)
Maltese: Effetti sekondarji mhux komuni (li jaffettwaw minn utent 1 sa 10 f'kull 1,000)
English: Figure 13b (Small Children, Thin Patients)
Maltese: Figura 13b (Tfal Żgħar, Pazjenti Irqaq) 6.
English: • Alcohol wipes
Maltese: • Biċċiet bl-alkoħol
English: 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.
Maltese: 9/l) kienet osservata b'mod komuni ma' prodott mediċinali ieħor li jinibixxi IL-1 użat f'popolazzjoni ta' pazjenti (bl-artrite rewmatojde) ħlief il-CAPS.
English: Table 3: Mean Symptom Scores in Adults (age 18 and older)
Maltese: Tabella 3: Medja tal-Punteġġi tas-Sintomi fl-Adulti (ta' 18-il sena jew aktar) Parti A Plaċebo (n=24)
English: USA
Maltese: Grupp
English: 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.
Maltese: Id-doża tal-bidu għall-adulti għandha tingħata bħala żewġ injezzjonijiet ta' 2 ml taħt il-ġilda (b'kollox 320 mg ta' rilonacept) mogħtija fl-istess jum f'siti differenti.
English: • one used for adding the sterile water (solvent) to the Rilonacept Regeneron powder
Maltese: • waħda tintuża biex iżżid l-ilma sterili (solvent) mat-trab ta' Rilonacept Regeneron
English: • Pneumonia
Maltese: • Pnewmonja
English: • After that, the recommended dose is 2.2 milligrams per kilogram, up to 160 mg, once weekly on the same day of the week.
Maltese: • Wara dik, id-doża rakkomandata hi ta' 2.2 milligrammi għal kull kilogramm, sa 160 mg, darba kull ġimgħa fl-istess jum tal-ġimgħa.
English: Powder vial
Maltese: Bidla Medja milLinja
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: 8 disposable 3-ml syringes 8 disposable 27-gauge, ½-inch needles
Maltese: 8 siringi ta' 3 ml li jintremew wara li jintużaw 8 labriet li jintremew wara li jintużaw, ta' qies 27, ta' ½ pulzier
English: 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%).
Maltese: Waqt Parti A tal-istudju pivitali (ara sezzjoni 5.1), l-inċidenza ta' pazjenti li rrappurtaw infezzjonijiet u li kienu kkunsidrati mill-investigatur li kienu relatati mal-kura, kienet akbar b'Rilonacept Regeneron
English: Using aseptic technique, Rilonacept Regeneron powder should be reconstituted with 2.3 ml solvent (water for injections) prior to administration.
Maltese: Bl-użu ta' teknika asettika, it-trab ta' Rilonacept Regeneron għandu jiġi rikostitwit bi 2.3 ml ta' solvent (ilma għall-injezzjonijiet) qabel l-għoti.
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 with 27-gauge, ½-inch needle (to obtain a final reconstitution volume of 2.75 ml).
Maltese: It-2.3 ml ta' solvent għandhom jinġibdu mill-kunjett tas-solvent li jkun imwaħħal direttament ma' siringa ta' 3 ml u mbagħad jiġu injettati ġol-kunjett bit-trab għar-rikostituzzjoni, bl-użu tal-labra tal-qies 27, ta' ½ pulzier (biex jinkiseb volum finali tar-rikostituzzjoni ta' 2.75 ml).
English: Neutropenia was observed commonly in patients with rheumatoid arthritis (not an approved use) who were administered Rilonacept Regeneron subcutaneously in clinical studies.
Maltese: In-newtropenja kienet osservata b'mod komuni f'pazjenti b'artrite rewmatojde (mhux użu approvat) li kienu ngħataw Rilonacept Regeneron taħt il-ġilda fi studji kliniċi.
English: How to store Rilonacept Regeneron Contents of the pack and other information
Maltese: Kif jidher Rilonacept Regeneron u l-kontenut tal-pakkett
English: Risk Management Plan (RMP)
Maltese: Pjan tal-Immaniġġjar tar-Riskju (RMP)
English: STEP 4: Dissolving Rilonacept Regeneron powder with the sterile water for injection (solvent) With one hand, hold the Rilonacept Regeneron powder vial on a firm surface.
Maltese: PASS 4: Kif tħoll it-trab ta' Rilonacept Regeneron bl-ilma sterili għall-injezzjoni (solvent) 1.
English: It is best to move to the next step and inject the medicine immediately after dissolving the Rilonacept Regeneron powder in the sterile water (solvent).
Maltese: Ikun aħjar li tmur għall-pass li jmiss u tinjetta l-mediċina immedjatament, wara li tħoll it-trab ta' Rilonacept Regeneron fl-ilma sterili (solvent).
English: How to store Rilonacept Regeneron
Maltese: X'fih Rilonacept Regeneron