natgillin/translations-raw huggingface dataset:
Cartons contain 1, 2 or 4 pre-filled syringes or pre-filled pens of Erelzi.
Škatle vsebujejo 1, 2 ali 4 napolnjene injekcijske brizge ali napolnjene injekcijske peresnike z zdravilom Erelzi.
ACR 20 and 50 responses were higher in patients treated with etanercept at 3 and 6 months than in patients treated with placebo (ACR 20: etanercept 62% and 59%, placebo 23% and 11% at 3 and 6 months, respectively: ACR 50: etanercept 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p < 0.01 etanercept vs. placebo at all timepoints for both ACR 20 and ACR 50 responses).
(ACR 20 po 3 oz. 6 mesecih: etanercept 62 % oz. 59 %, placebo 23 % oz. 11 %; ACR 50 po 3 oz. 6 mesecih: etanercept 41 % oz. 40 %, placebo 8 % oz. 5 %; p < 0,01 za etanercept proti placebu v vseh časovnih točkah, tako za odziv ACR 20 kot za odziv ACR 50).
Disease flare was defined as a ≥ 30% worsening in three of six JRA core set criteria and ≥ 30% improvement in not more than one of the six JRA core set criteria and a minimum of two active joints.
Ponoven izbruh bolezni je bil definiran kot ≥ 30 % poslabšanje treh od šestih osnovnih kazalcev JRA in ≥ 30 % izboljšanje največ enega od šestih glavnih kazalcev
However, your doctor may determine an alternative frequency at which to inject Erelzi.
Zdravnik vam lahko predpiše tudi drugačno pogostnost injiciranja zdravila Erelzi.
In a 2-year active-controlled study where patients were treated with either etanercept alone, methotrexate alone or etanercept in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
V dveletni študiji, nadzorovani z učinkovino, v kateri so bili bolniki zdravljeni z etanerceptom, metotreksatom ali kombinacijo etanercepta in metotreksata, je bila stopnja pogostnosti resnih okužb v treh skupinah podobna.
Etanercept was considered to be non-genotoxic from a battery of in vitro and in vivo studies.
Etanercept se ni izkazal za genotoksičnega v vrsti študij in vivo inin vitro.
Each pack contains 1, 2 or 4 pens, multipacks contain 12 (3 packs of 4) pens.
Eno pakiranje vsebuje 1, 2 ali 4 peresnike, skupno pakiranje vsebuje 12 (3 pakiranja po 4) peresnikov.
*see Description of selected adverse reactions, below.
*glejte Opis izbranih neželenih učinkov v nadaljevanju Opis izbranih neželenih učinkov
In clinical studies, concurrent administration of abatacept and etanercept resulted in increased incidences of serious adverse events.
V kliničnih študijah je sočasna uporaba abatacepta in etanercepta zvečala pojavnost resnih neželenih učinkov.
Malignant melanoma (see section 4.4), lymphoma, leukaemia
maligni melanom (glejte poglavje 4.4), limfom, levkemija karcinom Merklovih celic (glejte poglavje 4.4)
• If a caregiver or healthcare professional is giving you your injection, they may also inject into your outer upper arm.
• Če vam injekcijo daje negovalec ali zdravstveni delavec, lahko zdravilo injicira tudi na zunanji strani nadlakti.
A single 50 mg/ml injection of etanercept was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Enkratna injekcija etanercepta v odmerku 50 mg/ml je bioekvivalentna dvema sočasnima injekcijama po 25 mg/ml.
Both TNFRs exist naturally in membrane-bound and soluble forms.
Oboji receptorjiTNF v naravi obstajajo v dveh oblikah, tj. vezani na membrano in v topni obliki.
Undesirable effects in paediatric patients with plaque psoriasis
Neželeni učinki pri pediatričnih bolnikih s psoriazo v plakih
Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling).
okužbe (vključno s prehladi, sinuzitisom, bronhitisom, okužbami sečil in okužbami kože); reakcije na mestu injiciranja (vključno s krvavitvami, podplutbami, rdečino, srbenjem, bolečino in oteklino).
Additionally, some patients developed recall injection site reactions characterised by a skin reaction at the most recent site of injection, along with the simultaneous appearance of injection site reactions at previous injection sites.
Poleg tega so nekateri bolniki razvili tako imenovano spominsko lokalno reakcijo na mestu injiciranja; ob naslednjem injiciranju se je poleg reakcije na tedanjem mestu injiciranja sočasno pojavila reakcija tudi na prejšnjih mestih injiciranja.
A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
Tveganja za razvoj malignosti pri otrocih in mladostnikih, zdravljenih z antagonisti
In this configuration the needle guard is NOT ACTIVATED and the pre-filled syringe is ready for use
PRIPRAVLJENO NA UPORABO V tej konfiguraciji zapiralo igle NI AKTIVIRANOnapolnjena injekcijska brizga je pripravljena na uporabo
• Using a circular motion, clean the injection site with the alcohol swab.
• Uporabite alkoholni zloženec in s krožnimi gibi očistite mesto injiciranja.
If any of the following happen, do not inject more Erelzi.
Če se pojavi karkoli od naslednjega, zdravila Erelzi ne smete več uporabljati.
The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by an sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Pediatrični bolniki s psoriazo v plakih Učinkovitost etanercepta so ugotavljali v randomizirani, dvojno slepi, s placebom nadzorovani študiji pri 211 pediatričnih bolnikih, starih 4 do 17 let, z zmerno do hudo psoriazo v plakih (definirano z oceno sPGA ≥ 3, ki zajema ≥ 10 % telesne površine (BSA - Body Surface Area), in
If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose.
Če ste na predvideni odmerek zdravila Erelzi pozabili, ga morate injicirati takoj, ko se spomnite, razen če je naslednji odmerek predviden za naslednji dan.
Patients should be evaluated for infections before, during, and after treatment with Erelzi, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Okužbe Pred zdravljenjem z zdravilom Erelzi, med njim in po njem je treba bolnike pregledati glede okužb in pri tem upoštevati, da je povprečni razpolovni čas izločanja etanercepta iz telesa približno 70 ur
70b a: 25 mg etanercept SC twice weekly b: p < 0.001, etanercept vs. placebo c: p < 0.01, etanercept vs. placebo
70b a: 25 mg etanercepta subkutano dvakrat na teden b: p < 0,001, etanercept v primerjavi s placebom c: p < 0,01, etanercept v primerjavi s placebom
One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with etanercept for up to approximately 6 years, including 231 patients treated with etanercept in combination with methotrexate in a 2-year active-controlled study.
Sto devetindvajset (129) novih malignih obolenj različnih tipov so ugotovili pri 4.114 bolnikih z revmatoidnim artritisom, zdravljenih v kliničnih preskušanjih z etanerceptom do približno 6 let,
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in etanercept-treated patients.
V kliničnih študijah z etanerceptom, ki so trajale več kot 2 leti in so vključevale 351 bolnikov z ankilozirajočim spondilitisom, so poročali o 6 primerih malignega obolenja.
• Reminder to record brand name and batch number of the medication
• opomin, da je treba zapisati trgovsko ime in številko serije zdravila;
Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including etanercept, has been reported.
Reaktivacija hepatitisa B Pri bolnikih, ki so kdaj že bili okuženi z virusom hepatitisa B (HBV) in so se zdravili z zaviralci TNF,
The double-blind period was followed by an open-label period during which all patients received etanercept 50 mg weekly for up to an additional 92 weeks.
Dvojno slepemu obdobju je sledilo odprto obdobje, med katerim so vsi bolniki prejemali etanercept v odmerku 50 mg na teden, kar je trajalo do 92 dodatnih tednov.
Compared to placebo, treatment with etanercept resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
V primerjavi s placebom je po dajanju etanercepta prišlo do izboljšanja pri ASAS 20, ASAS 50 in
In studies when adult patients received concurrent treatment with etanercept plus anakinra, a higher rate of serious infections compared to etanercept alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count ˂ 1,000/mm3).
Sočasno zdravljenje z anakinro V študijah, v katerih so odrasli bolniki sočasno prejemali etanercept in anakinro, so opažali večjo stopnjo resnih okužb v primerjavi s samim etanerceptom in pri 2 % bolnikov (3/139) se je pojavila nevtropenija (absolutna koncentracija nevtrofilcev < 1.000/mm3).
Radiographic progression: comparison of etanercept vs. methotrexate in patients with RA of < 3 years duration
Radiografsko napredovanje: primerjava etanercepta z metotreksatom pri bolnikih z RA, ki je trajal < 3 leta
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI)BIOLOŠKE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
74.5% †,ϕ
65,5 % 74,5 % †,φ
A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3 months during the trial.
duševno zdravje, splošno zdravstveno stanje in poddomene zdravstvenega stanja, povezane z artritisom, so med preskušanjem uporabili vsake 3 mesece.
Significant advantages for etanercept in combination with methotrexate compared with etanercept monotherapy and methotrexate monotherapy were also observed after 24 months.
Pomembne prednosti etanercepta v kombinaciji z metotreksatom v primerjavi z monoterapijo z etanerceptom in monoterapijo z metotreksatom so prav tako ugotovili po 24 mesecih.
Uncommon ≥ 1/1,000 to
≥ 1/1.000 do
The active substance is etanercept.
Učinkovina je etanercept.
Vasculitis (including antineutrophilic cytoplasmic antibody positive vasculitis)
(vključno z vaskulitisom s pozitivnimi antinevtrofilnimi citoplazemskimi protitelesi)
Based on the review of the literature and spontaneous reporting presented in this PSUSA, covering the period from 15 July 2018 to 14 January 2019, as well as cumulative data since the European birth date, the PRAC considered that a causal relationship between inflammatory bowel disease and etanercept cannot be excluded and therefore recommends that the product information of medicinal products containing the active substance etanercept should be updated as follows: update of section 4.8 of the SmPC to add inflammatory bowel disease with a frequency uncommon.
14. januarja 2019, ter kumulativnih podatkov od datuma pridobitve dovoljenja za promet z zdravilom v Evropi, odbor PRAC meni, da ni mogoče izključiti vzročne povezanosti med vnetno črevesno boleznijo in etanerceptom, zato priporoča posodobitev informacij o zdravilih, ki vsebujejo učinkovino etanercept, in sicer kot sledi: posodobitev poglavja 4.8 povzetka glavnih značilnosti zdravila tako, da bo vključevalo vnetno črevesno bolezen s pogostnostjo ''občasni''.
Paediatric patients weighing 62.5 kg or more can be dosed 25 mg given twice a week or 50 mg given once a week using a fixed-dose pre-filled syringe or pre-filled pen.
Pediatrični bolniki, ki tehtajo 62,5 kg ali več, lahko odmerek 25 mg dvakrat na teden ali 50 mg enkrat na teden prejmeko kot fiksni odmerek v obliki napolnjene injekcijske brizge ali napolnjenega injekcijskega peresnika.
In a polyarticular-course juvenile idiopathic arthritis trial with etanercept, 69 patients (aged 4 to 17 years) were administered 0.4 mg etanercept/kg twice weekly for three months.
V kliničnem preskušanju pri 69 bolnikih s poliartikularnim potekom juvenilnega idiopatskega artritisa, starih od 4 do 17 let, so injicirali 0,4 mg etanercepta/kg 2-krat tedensko v obdobju treh mesecev.
TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55)
TNF in limfotoksin sta provnetna citokina, ki se vežeta na dva različna tipa receptorjev na površini celice: 55-kilodaltonske (p55) in 75-kilodaltonske (p75) receptorje TNF.
Concurrent administration of etanercept and anakinra has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone.
Sočasno zdravljenje z anakinro Sočasna uporaba etanercepta in anakinre je bila povezana s povečanim tveganjem za pojav resnih okužb in nevtropenije v primerjavi z zdravljenjem samo z etanerceptom.
Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Dokazali so, da etanercept sam ali v kombinaciji z metotreksatom upočasni hitrost napredovanja poškodb sklepov, merjenih z rentgenskim slikanjem, in izboljša telesno funkcijo.
In the post-marketing setting, cases of leukaemia have been reported in patients treated with TNF-antagonists.
V obdobju trženja so pri bolnikih, zdravljenih z antagonisti TNF, poročali o primerih levkemije.
In part 2, 6 of 25 (24%) patients remaining on etanercept experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p = 0.007).
V drugem delu je 6 od 25 (24 %) bolnikov, ki so ostali na etanerceptu, doživelo ponoven izbruh bolezni, v primerjavi z 20 od 26 (77 %) bolnikov, ki so v drugem delu prejemali placebo
Your doctor may decide to continue to monitor you or the child for the presence of infections after you or the child stop using Erelzi.
Vaš zdravnik se bo morda odločil, da bo vas ali vašega otroka tudi po koncu zdravljenja z zdravilom Erelzi spremljal glede prisotnosti okužb.
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the post-marketing period (see section 4.4).
O različnih malignih obolenjih (vključno z rakom dojke in pljuč ter limfomi) so poročali tudi v obdobju trženja zdravila (glejte poglavje 4.4).
Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF.
Etanercept je kompetitivni zaviralec vezave TNF na receptorje na površini celice in torej zavira biološko aktivnost
Erelzi should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years or weighing less than 62.5 kg, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years or weighing less than 62.5 kg, or in children with psoriasis below the age of 6 years or weighing less than 62.5 kg.
Pri otrocih s poliartritisom ali z razširjenim oligoartritisom, mlajših od 2 let ali ki tehtajo manj kot 62,5 kg, otrocih z artritisom, povezanim z entezitisom, ali s psoriatičnim artritisom, mlajših od 12 let ali ki tehtajo manj kot 62,5 kg, in otrocih s psoriazo, mlajših od 6 let ali ki tehtajo manj kot 62,5 kg, se zdravila Erelzi običajno ne sme uporabljati.
• Signs of cancers: cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer.
Rak lahko prizadene katerikoli del telesa, vključno s kožo in krvjo.
EU/1/17/1195/012 12 pre-filled SensoReady pens
EU/1/17/1195/012 12 napolnjenih injekcijskih peresnikov SensoReady
Do not use this medicine if the seal of the blister is broken, as it may not be safe for you to use.
Če sta zunanja škatla ali pretisni omot odprta, ne uporabljajte tega zdravila, saj morda ni varno za uporabo.
Infection (including upper respiratory tract infection, bronchitis, cystitis, skin infection)*
(vključno z okužbo zgornjih dihal, bronhitisom, cistitisom in okužbo kože)*
In this configuration the needle guard is ACTIVATEDDO NOT USE the pre-filled syringe
V tej konfiguraciji je zapiralo igle AKTIVIRANO - NE UPORABLJAJTE napolnjene injekcijske brizge
Do not use if the syringe is broken or the needle guard is activated.
Prav tako zdravila ne uporabljajte, če je injekcijska brizga poškodovana ali če je zapiralo igle aktivirano.
• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Erelzi, and contact your doctor immediately.
• Alergijske reakcije: Če se pri vas ali otroku pojavijo alergijske reakcije, na primer tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo Erelzi in nemudoma obvestite zdravnika.
There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with etanercept from post-marketing sources, including a very small number of cases indicating a positive rechallenge (see section 4.4).
Viri iz obdobja trženja so poročali o vnetni črevesni bolezni in uveitisu pri bolnikih z JIA, ki so se zdravili z etanerceptom, vključno z zelo majhnim številom primerov, ki kažejo na ponoven pojav bolezni ob naslednjem dajanju zdravila (glejte poglavje 4.4).
• Additional risk minimisation measures
• Dodatni ukrepi za zmanjševanje tveganj Opozorilna kartica za bolnika
• Severe psoriasis in patients from the age of 6 years and weighing 62.5 kg or more who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
• za zdravljenje hude psoriaze pri bolnikih, starejših od 6 let, ki tehtajo 62,5 kg ali več, ki so se nezadostno odzvali na fototerapije ali druge sistemske terapije (ali jih niso prenašali).
Pairwise comparison p-values: * = p < 0.05 for comparisons of etanercept vs. methotrexate, † = p < 0.05 for comparisons of etanercept + methotrexate vs. methotrexate and ϕ = p < 0.05 for comparisons of etanercept + methotrexate vs. etanercept.
Vrednosti p za primerjavo po parih: * = p < 0,05 za primerjavo etanercepta z metotreksatom, † = p < 0,05 za primerjavo kombinacije etanercept + metotreksat z metotreksatom in φ = p < 0,05 za primerjavo kombinacije etanercept + metotreksat z etanerceptom.
After the medicine has been injected, the needle guard will be activated to cover the needle.
Po injiciranju zdravila se zapiralo igle aktivira in pokrije iglo.
L-Lysine hydrochloride Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
L-lizinijev klorid natrijev hidroksid (za uravnavanje pH-vrednosti) solna kislina (za uravnavanje pH-vrednosti) voda za injekcije
What you need to know before you use Erelzi
Kaj morate vedeti, preden boste uporabili zdravilo Erelzi Ne uporabljajte zdravila Erelzi
Do not use this medicine after the expiry date which is stated on the carton and the label of the pre-filled syringe after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki napolnjene injekcijske brizge poleg oznake »EXP«.
Erelzi may be stored outside of the refrigerator at temperatures up to a maximum of 25 °C for a single period of up to four weeks; after which, it should not be refrigerated again.
Pred pripravo raztopine zdravila Erelzi lahko zdravilo Erelzi shranjujete izven hladilnika pri temperaturi do največ 25 °C za enkratno obdobje do štirih tednov, po katerem se ga ne sme več ohladiti.
39.8% †, ϕ
22,0 % 39,8 % †,φ
Erelzi contains sodium
Zdravilo Erelzi vsebuje natrij
In another open-label single-arm study, 60 patients with extended oligoarthritis (15 patients aged 2 to 4, 23 patients aged 5 to 11 and 22 patients aged 12 to 17 years old), 38 patients with enthesitis-related arthritis (12 to 17 years old), and 29 patients with psoriatic arthritis (12 to 17 years old) were treated with etanercept at a dose of 0.8 mg/kg (up to a maximum of 50 mg per dose) administered weekly for 12 weeks.
V drugi odprti študiji z eno skupino se je z etanerceptom v odmerku 0,8 mg/kg (do največ 50 mg na odmerek) enkrat na teden zdravilo 60 bolnikov z razširjenim oligoartritisom (15 bolnikov, starih od 2 do 4 leta, 23 bolnikov, starih od 5 do 11 let, in 22 bolnikov, starih od 12 do 17 let), 38 bolnikov z artritisom, povezanim z entezitisom (starih od 12 do 17 let) in 29 bolnikov s psoriatičnim artritisom (starih od 12 do 17 let).
Thus, it is not possible to administer Erelzi to paediatric patients that require less than a full 25 mg or 50 mg dose.
Zato zdravila Erelzi ni mogoče dati pediatričnim bolnikom, ki potrebujejo odmerek manj kot polnih 25 mg ali 50 mg. Pediatrični bolniki, ki potrebujejo odmerek, drugačen kot polnih 25 mg ali 50 mg, ne smejo dobiti zdravila Erelzi.
Do not use the syringe after the expiry date which is stated on the outer box or syringe label after “EXP”.
Injekcijske brizge ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli in na nalepki injekcijske brizge poleg oznake "EXP".
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) (see section 5.1).
Zdravljenje zmerne do hude psoriaze v plakih pri odraslih, ki se ne odzovejo na drugo sistemsko zdravljenje, vključno s ciklosporinom, metotreksatom ali psoralenom in ultravijolično svetlobo UV-A
• if you or the child have, or are at risk of developing a serious blood infection called sepsis.
• če imate vi ali otrok resno okužbo krvi (sepso) ali če pri vas ali otroku obstaja tveganje za njen pojav.
Erelzi is supplied as a solution for injection in a pre-filled pen (SensoReady).
Zdravilo Erelzi je na voljo kot raztopina za injiciranje v napolnjenem injekcijskem peresniku (SensoReady).
This medicinal product contains less than 1 mmol sodium (23 mg) per 50 mg, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 50 mg, kar v bistvu pomeni ‘brez natrija'.
There have been reports of hypoglycaemia following initiation of etanercept in patients receiving medicinal product for diabetes, necessitating a reduction in anti-diabetic medicinal products in some of these patients.
poročali o hipoglikemiji, zaradi katere je bilo treba pri nekaterih od teh bolnikov zmanjšati odmerek zdravila za zdravljenje sladkorne bolezni.
63.2% †, ϕ
43,0 % 63,2 % †,φ
Physicians should exercise caution when considering the use of Erelzi in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes.
Zdravniki morajo biti previdni, kadar se odločajo za zdravljenje z zdravilom Erelzi pri bolnikih s ponavljajočimi se ali kroničnimi okužbami v anamnezi ali z drugimi osnovnimi stanji (kot je na primer napredovala ali neurejena sladkorna bolezen), ki bi lahko povečala dovzetnost bolnikov za okužbe.
With twice-weekly doses, it is anticipated that steady-state concentrations are approximately twice as high as those observed after single doses.
Pričakovati je, da bodo koncentracije v stanju dinamičnega ravnovesja po odmerjanju 2-krat tedensko približno dvakrat večje od tistih, izmerjenih po enkratnem odmerku.
Instructions for use and handling of the Erelzi pre-filled syringe Before injection, Erelzi single-use pre-filled syringe should be allowed to reach room temperature (approximately 15 to 30 minutes).
Navodila za uporabo in ravnanje z zdravilom Erelzi napolnjena injekcijska brizga Pred injiciranjem je treba napolnjeno injekcijsko brizgo zdravila Erelzi za enkratno uporabo segreti na sobno temperaturo (počakati približno 15 do 30 minut).
Key elements of the Erelzi Patient Alert Card
Ključne sestavine opozorilne kartice za bolnika
This medicinal product contains less than 1 mmol sodium (23 mg) per 25 mg or 50 mg, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 25 mg ali 50 mg, kar v bistvu pomeni ‘brez natrija'.