natgillin/translations-raw huggingface dataset:
h. Preparing the injection site and injecting the LIFMIOR solution
Priprava mesta injiciranja in injiciranje raztopine zdravila LIFMIOR
24a n = 193 wk 12
teden n = 193
Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): alergijske reakcije; vročina; izpuščaj; srbenje; protitelesa proti normalnemu tkivu (nastanek avtoprotiteles).
Do not use this medicine after the expiry date which is stated on the carton and on the MYCLIC pre-filled pen after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in na napolnjenem injekcijskem peresniku MYCLIC poleg oznake ''EXP''.
By looking though the inspection window, the solution should be clear to slightly opalescent, colourless to pale yellow or pale brown, and may contain small translucent or white particles of protein.
Pri pogledu skozi okence za pregledovanje mora biti raztopina bistra do rahlo opalescentna, brezbarvna do bledo rumena oziroma bledo rjava ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
• With the vial held upside down, unscrew the syringe from the vial adaptor by turning it anti-clockwise (see Diagram 12).
Vialo še vedno držite zasukano na glavo in odvijte brizgo iz adapterja tako, da jo zavrtite v nasprotno smer urnega kazalca (glejte sliko 12).
Each pre-filled syringe contains 1.0 ml of solution, providing 50 mg of etanercept.
Ena napolnjena injekcijska brizga vsebuje 1,0 ml raztopine, ki vsebuje 50 mg etanercepta.
Each vial of LIFMIOR contains 10 mg etanercept.
Ena viala zdravila LIFMIOR vsebuje 10 mg etanercepta.
Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) There have been reports of IBD and uveitis in JIA patients being treated with LIFMIOR (see section
Kronična vnetna črevesna bolezen (KVČB): Pri bolnikih z juvenilnim idiopatskim artritisom (JIA), ki so se zdravili z zdravilom LIFMIOR, so poročali o primerih KVČB.
28b a: p<0.001, LIFMIOR vs. placebo b: p = 0.002, LIFMIOR vs. placebo
ASAS 70 2 tedna 3 meseci 6 mesecev b a: p < 0,001, zdravilo LIFMIOR proti placebu b: p = 0,002, zdravilo LIFMIOR proti placebu
12b
Uvod b.
Do not use this medicine after the expiry date which is stated on the carton and the label after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake ''EXP''.
12 pre-filled syringes 12 alcohol swabs
12 napolnjenih injekcijskih brizg 12 alkoholnih blazinic
LIFMIOR 25 mg solution for injection in pre-filled syringe LIFMIOR 50 mg solution for injection in pre-filled syringe
LIFMIOR 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi LIFMIOR 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using LIFMIOR in patients who have congestive heart failure (CHF).
Zdravniki morajo biti previdni, kadar predpišejo zdravilo LIFMIOR bolnikom s kongestivnim srčnim popuščanjem (KSP).
• Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because LIFMIOR needs to be used with caution under these circumstances.
Kongestivno srčno popuščanje: Povejte zdravniku, če se je pri vas ali otroku kdaj pojavilo kongestivno srčno popuščanje.
Cases of active tuberculosis including miliary tuberculosis and tuberculosis with extra-pulmonary location have been reported in patients treated with LIFMIOR.
Pri bolnikih, zdravljenih z zdravilom LIFMIOR, so poročali o primerih aktivne tuberkuloze, vključno z miliarno tuberkulozo in ekstrapulmonarno tuberkulozo.
• Congestive heart failure: Tell your doctor if the child has a history of congestive heart failure, because LIFMIOR needs to be used with caution under these circumstances.
Kongestivno srčno popuščanje: Povejte zdravniku, če se je pri otroku kdaj pojavilo kongestivno srčno popuščanje.
Placing the needle on the syringe
Namestitev igle na injekcijsko brizgo
Each pack contains 4, 8 or 24 pre-filled syringes and 4, 8 or 24 alcohol swabs.
Eno pakiranje vsebuje 4, 8 ali 24 napolnjenih injekcijskih brizg in 4, 8 ali 24 alkoholnih blazinic.
Each vial of LIFMIOR 25 mg contains 25 mg of etanercept.
Ena viala zdravila LIFMIOR 25 mg vsebuje 25 mg etanercepta.
In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of autoimmune hepatitis in patients receiving etanercept without concomitant methotrexate was 0.02% (frequency rare).
V nadzorovanih kliničnih preskušanjih etanercepta za vse indikacije je bila pogostnost (delež pojavnosti) avtoimunskega hepatitisa pri bolnikih, ki so prejemali etanercept brez sočasnega metotreksata, 0,02 % (pogostnost: redki).
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake ''EXP''.
g. Choosing an injection site
Izbira mesta injiciranja
CARTON TEXT - (25 mg Pre-filled Syringe) - EU/1/16/1165/005-007
BESEDILO NA ŠKATLI - (25 mg napolnjena injekcijska brizga) - EU/1/16/1165/005-007
MRIs of the sacroiliac joint and spine were obtained to assess inflammation at baseline and at weeks 12 and 104.
Za oceno vnetja ob izhodišču in po 12 ter 104 tednih so uporabili magnetnoresonančno slikanje sakroiliakalnega sklepa in hrbtenice.
Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.
Pri nekaterih bolnikih, ki so prejemali zdravilo LIFMIOR, se je pojavil kožni rak. Povejte zdravniku, če se pri vas ali otroku razvije kakšna sprememba videza kože ali rašče na koži.
A biexponential curve is required to describe the concentration time curve of etanercept.
Krivulja koncentracije zdravila v odvisnosti od časa je pri etanerceptu bieksponencialna.
Detailed instructions on how to inject LIFMIOR are provided in section 7, “Using the MYCLIC pre-filled pen to inject LIFMIOR”.
Podrobna navodila o injiciranju zdravila LIFMIOR so v poglavju 7 “Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila LIFMIOR”.
Women using LIFMIOR should not breast-feed, since LIFMIOR passes into human breast milk.
Zdravilo LIFMIOR prehaja v materino mleko, zato bolnice med zdravljenjem z zdravilom LIFMIOR ne smejo dojiti.
Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with LIFMIOR use.
Pri uporabi zdravila LIFMIOR so poročali o redkih primerih demielinizacije centralnega in zelo redkih primerih demielinizacije perifernega živčevja.
Patients aged 4 to 17 years with moderately to severely active polyarticular-course juvenile idiopathic arthritis refractory to, or intolerant of, methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal anti-inflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum).
Bolniki so nadaljevali zdravljenje s stalnim odmerkom enega nesteroidnega protivnetnega zdravila in/ali prednizona (< 0,2 mg/kg/dan ali največ 10 mg).
(frequency rare).
Organski sistem Zelo pogosti
Cartons contain 4, 8 or 24 pre-filled syringes of LIFMIOR and 4, 8 or 24 alcohol swabs.
Škatle vsebujejo 4, 8 ali 24 napolnjenih injekcijskih brizg zdravila LIFMIOR in 4, 8 ali 24 alkoholnih blazinic.
Inspection window will have turned purple
Okence za pregledovanje se obarva vijolično.
Contact your doctor before using LIFMIOR if the needle cover will be handled by, or LIFMIOR will be given to, someone with a known or possible hypersensitivity (allergy) to latex.
Če bo s pokrovčkom igle rokovala ali zdravilo LIFMIOR dobivala oseba z znano ali možno preobčutljivostjo (alergijo) na lateks, se pred uporabo zdravila LIFMIOR posvetujte z zdravnikom.
n = 46 wk 12
teden n = 46
• Chickenpox: Tell your doctor if the child is exposed to chickenpox when using LIFMIOR.
Norice: Povejte zdravniku, če je bil otrok med zdravljenjem z zdravilom LIFMIOR izpostavljen noricam.
Pairwise comparison p-values: * = p < 0.05 for comparisons of LIFMIOR vs. methotrexate, † = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. methotrexate and φ = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. LIFMIOR.
Vrednosti p za primerjavo po parih: * = p < 0,05 za primerjavo zdravila LIFMIOR z metotreksatom, † = p < 0,05 za primerjavo kombinacije zdravilo LIFMIOR + metotreksat z metotreksatom in  = p < 0,05 za primerjavo kombinacije zdravilo LIFMIOR + metotreksat z zdravilom LIFMIOR.
Plaque psoriasis
Psoriaza v plakih
See section 5 for instructions on how to store LIFMIOR.
Za navodila o shranjevanju zdravila LIFMIOR glejte poglavje 5.
The dose should be 25 mg twice weekly or 50 mg once weekly.
Odmerek je 25 mg dvakrat na teden ali 50 mg enkrat na teden.
LIFMIOR is reconstituted with 1 ml water for injections before use, and administered by subcutaneous injection.
Pred uporabo in subkutanim injiciranjem zdravilo LIFMIOR rekonstituirajte v 1 ml vode za injekcije.
n = 96 wk 12
teden n = 96
Serious adverse reactions have also been reported for LIFMIOR.
Pri uporabi zdravila LIFMIOR so poročali tudi o pojavu resnih neželenih učinkov.
In a fourth study, the safety and efficacy of 50 mg LIFMIOR (two 25 mg SC injections) administered once weekly vs 25 mg LIFMIOR administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
V četrti, dvojno slepi in s placebom nadzorovani študiji so pri 356 bolnikih z aktivnim ankilozirajočim spondilitisom vrednotili varnost in učinkovitost dajanja zdravila LIFMIOR v odmerku 50 mg enkrat na teden (dve 25 mg subkutani injekciji) v primerjavi z dajanjem zdravila LIFMIOR v odmerku 25 mg dvakrat na teden.
The 10 mg presentation is for paediatric patients prescribed a dose of 10 mg or less.
10 mg viala je namenjena za uporabo pri otrocih, ki potrebujejo odmerek 10 mg ali manj.
CARTON TEXT - (50 mg Pre-filled Pen) - EU/1/16/1165/011-013
BESEDILO NA ŠKATLI - (50 mg napolnjeni injekcijski peresnik) - EU/1/16/1165/011-013
These include the alcohol swab from the LIFMIOR carton and a cotton ball or gauze.
Pripravite si še druge stvari, ki jih boste potrebovali pri injiciranju, to sta alkoholna blazinica iz škatle z zdravilom LIFMIOR in košček vate ali gaze.
• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, 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 LIFMIOR in nemudoma obvestite zdravnika.
LIFMIOR 25 mg powder and solvent for solution for injection etanercept
LIFMIOR 25 mg prašek in vehikel za raztopino za injiciranje etanercept
CARTON TEXT - (50 mg Pre-filled Syringe) - EU/1/16/1165/008-010
BESEDILO NA ŠKATLI - (50 mg napolnjena injekcijska brizga) - EU/1/16/1165/008-010
The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
Domnevajo, da je mehanizem delovanja etanercepta kompetitivna inhibicija vezave TNF na receptorje za TNF na površini celice.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Using the MYCLIC pre-filled pen to inject LIFMIOR."
Izčrpna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila LIFMIOR".
New onset cardiac failure congestive (see section 4.4)
nastanek kongestivnega srčnega popuščanja (glejte poglavje 4.4)
Remissionc
Odziv
The presence of hepatic impairment should not require a change in dosage.
Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
25 mg LIFMIOR administered twice weekly is the recommended dose.
Priporočeni odmerek je 25 mg zdravila LIFMIOR dvakrat na teden.
• Allergic reactions: If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately.
Alergijske reakcije: Če se pri otroku pojavijo alergijske reakcije, na primer tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo LIFMIOR in nemudoma obvestite zdravnika.
Tell your doctor if the child develops any change in the appearance of the skin or growths on the skin.
Pri nekaterih bolnikih, ki so prejemali zdravilo LIFMIOR, se je pojavil kožni rak. Povejte zdravniku, če se pri otroku razvije kakšna sprememba videza kože ali rašče na koži.
These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on the skin
Znaki lahko vključujejo zmanjšanje telesne mase, vročino, pojav otekline (z bolečino ali brez nje), trdovratnega kašlja, zatrdlin ali izrastkov na koži;
Do not inject into tender, bruised or hard skin.
Ne injicirajte v predelih, kjer je koža občutljiva, poškodovana ali trda.
If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately.
Če se pri vas ali otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo LIFMIOR in nemudoma obvestite zdravnika.
Cardiac disorders
Kongestivno srčno popuščanje
LIFMIOR 25 mg powder and solvent for solution for injection.
LIFMIOR 25 mg prašek in vehikel za raztopino za injiciranje
Each pre-filled syringe of LIFMIOR contains 25 mg etanercept.
Ena napolnjena injekcijska brizga zdravila LIFMIOR vsebuje 25 mg etanercepta.
A 25 mg strength of LIFMIOR is available for doses of 25 mg.
Predpisali so vam zdravilo LIFMIOR v jakosti 50 mg. Za 25 mg odmerek je na voljo zdravilo LIFMIOR jakosti 25 mg.
If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately.
Če se pri otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo LIFMIOR in nemudoma obvestite zdravnika.
• This medicine has been prescribed for you or a child in your care.
Zdravilo je bilo predpisano vam ali otroku, za katerega skrbite, osebno in ga ne smete dajati drugim.
Pairwise comparison p-values: † = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. methotrexate and φ = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. LIFMIOR.
Vrednosti p za primerjavo po parih: † = p < 0,05 za primerjavo kombinacije zdravila LIFMIOR + metotreksat z metotreksatom in  = p < 0,05 za primerjavo kombinacije zdravila LIFMIOR + metotreksat z zdravilom LIFMIOR.
The recommended dose is 25 mg LIFMIOR administered twice weekly, or 50 mg administered once weekly.
Priporočeni odmerek je 25 mg zdravila LIFMIOR dvakrat na teden ali 50 mg enkrat na teden.
LIFMIOR 25 mg solution for injection in pre-filled syringe etanercept
LIFMIOR 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept
The solution should be clear or slightly opalescent, colourless to pale yellow or pale brown, and may contain small white or almost transparent particles of protein.
Raztopina mora biti bistra ali rahlo svetlikajoča, brezbarvna do bledo rumena oziroma bledo rjava in lahko vsebuje majhne bele ali skoraj prozorne delce beljakovine.
Each MYCLIC pre-filled pen contains 50 mg of etanercept.
En napolnjeni injekcijski peresnik MYCLIC vsebuje 50 mg etanercepta.
The needle cover should not be removed while allowing the prefilled syringe to reach room temperature.
Med čakanjem, da se napolnjeni injekcijski peresnik segreje na sobno temperaturo, pokrovčka igle ne smete odstraniti.
Detailed instructions on how to inject LIFMIOR are provided in section 7, “Instructions for preparing and giving an injection of LIFMIOR”.
Podrobna navodila o injiciranju zdravila LIFMIOR so v poglavju 7 “Navodila za pripravo in dajanje injekcije zdravila LIFMIOR”.
Always use this medicine exactly as the doctor has told you.
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika.
Detailed instructions on how to prepare and inject LIFMIOR are provided in section 7, “Instructions for preparing and giving an injection of LIFMIOR”.
Podrobna navodila o pripravi in injiciranju zdravila LIFMIOR so v poglavju 7 “Navodila za pripravo in dajanje injekcije zdravila LIFMIOR”.
In this study most psoriatic arthritis patients receiving LIFMIOR were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower and few patients had two-fold rises in titres compared to patients not receiving LIFMIOR.
Večina bolnikov s psoriatičnim artritisom, ki so dobivali zdravilo LIFMIOR, je v tej študiji zmogla učinkovit imunski odziv celic B na polisaharidno cepivo proti pnevmokokom.
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the postmarketing period (see section 4.8).
Čvrste in hematopoetične maligne bolezni (razen kožnega raka) V obdobju trženja zdravila so prejeli več poročil o raznih malignih boleznih (vključno z rakom dojke in pljuč ter limfomi) (glejte poglavje 4.8).
Each vial of LIFMIOR contains 25 mg etanercept.
Ena viala zdravila LIFMIOR vsebuje 25 mg etanercepta.
If this is the case, start again with another vial.
V tem primeru si pripravite nov podstavek za odmerjanje.
• Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Bolezni krvi: Če se pri vas ali otroku pojavi katerikoli od znakov ali simptomov, kot so trdovratna vročina, vnetje žrela, podplutbe na koži, krvavitve ali bledica, se nemudoma posvetujte z zdravnikom.
Each pack contains 2, 4 or 12 pre-filled syringes and 2, 4 or 12 alcohol swabs.
Eno pakiranje vsebuje 2, 4 ali 12 injekcijskih peresnikov in 2, 4 ali 12 alkoholnih blazinic.
The 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg.
Pri otrocih z juvenilnim idiopatskim artritisom, ki imajo telesno maso manjšo od 25 kg, bo morda primernejša uporaba 10 mg viale.
and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
Etanercept je fuzijska beljakovina receptorja p75 Fc za humani tumorje nekrotizirajoči faktor.
Each pre-filled syringe of LIFMIOR contains 50 mg etanercept.
Ena napolnjena injekcijska brizga zdravila LIFMIOR vsebuje 50 mg etanercepta.
• Blood disorders: Seek medical advice immediately if the child has any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Bolezni krvi: Če se pri otroku pojavi katerikoli od znakov ali simptomov, kot so trdovratna vročina, vnetje žrela, podplutbe na koži, krvavitve ali bledica, se nemudoma posvetujte z zdravnikom.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of LIFMIOR”.
Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA LIFMIOR".
Comprehensive instructions for the preparation and administration of the reconstituted LIFMIOR vial are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of LIFMIOR."
Obsežna navodila za pripravo in aplikacijo rekonstituirane viale zdravila LIFMIOR so navedena v navodilu za uporabo, poglavje 7 "NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA LIFMIOR".
Comprehensive instructions for the preparation and administration of the reconstituted LIFMIOR vial are given in the package leaflet, section 7, “INSTRUCTIONS FOR PREPARATION AND GIVING AN INJECTION OF LIFMIOR”.
Obsežna navodila za pripravo in aplikacijo rekonstituirane viale zdravila LIFMIOR so navedena v navodilu za uporabo, poglavje 7 "Navodila za pripravo in dajanje injekcije zdravila LIFMIOR".
LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use Etanercept
LIFMIOR 10 mg prašek za raztopino za injiciranje etanercept subkutana uporaba
No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients.
V kliničnih preskušanjih pri bolnikih z revmatoidnim artritisom niso opazili take vrste toksičnosti, ki bi omejevala odmerjanje.
LIFMIOR did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
Tudi pri opicah cynomolgus, ki so subkutano prejemale odmerek 15 mg/kg 2-krat tedensko 4 ali 26 tednov zapored, zdravilo LIFMIOR ni povzročilo toksičnosti, ki bi omejevala višino odmerka, niti toksičnosti za tarčne organe.
(If not, don't use the dose tray and consult your pharmacist).
Podstavek z zdravilom mora vsebovati vse spodaj navedene pripomočke (če jih ne, ne uporabite zdravila in se posvetujte s farmacevtom).
How to store LIFMIOR
Shranjevanje zdravila LIFMIOR
It should be clear or slightly opalescent, colourless to pale yellow or pale brown, and may contain small white or almost transparent particles of protein.
Raztopina mora biti bistra ali rahlo svetlikajoča, brezbarvna do bledorumena oziroma bledo rjava in lahko vsebuje majhne bele ali skoraj prozorne delce beljakovine.
The solution should be clear to slightly opalescent, colourless to pale yellow or pale brown, and may contain small translucent or white particles of protein.
Raztopina mora biti bistra do rahlo opalescentna, brezbarvna do bledo rumena oziroma bledo rjava ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
LIFMIOR 50 mg solution for injection in pre-filled syringe.
LIFMIOR 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Cartons contain 2, 4 or 12 pre-filled syringes of LIFMIOR with 2, 4 or 12 alcohol swabs.
Škatle vsebujejo 2, 4 ali 12 napolnjenih injekcijskih brizg zdravila LIFMIOR in 2, 4 ali 12 alkoholnih blazinic.
LIFMIOR 50 mg solution for injection in pre-filled syringe etanercept
LIFMIOR 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku etanercept
Each pre-filled pen contains 50 mg of etanercept.
En napolnjen injekcijski peresnik vsebuje 50 mg etanercepta.
2 pre-filled syringes2 alcohol swabs
2 napolnjeni injekcijski brizgi 2 alkoholni blazinici
Do not use this medicine after the expiry date which is stated on the carton and pre-filled syringe after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in napolnjeni injekcijski brizgi poleg oznake ''EXP''.
The solution should be clear and colourless to pale yellow or pale brown, with no lumps, flakes, or particles.
Raztopina mora biti bistra in brezbarvna do bledo rumena ali bledo rjava in ne sme vsebovati kepic, kosmičev ali delcev.
• Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with LIFMIOR.
Hepatitis B: Če ste vi ali vaš otrok kdaj imeli hepatitis B, o tem obvestite zdravnika.
With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 19).
Nato potisnite bat tako, da počasi in enakomerno injicirate vso raztopino (glejte sliko 19).
With experience, you will find the angle that is most comfortable for you or the child. Be careful not to push the needle into the skin too slowly, or with great force.
Z izkušnjami boste našli kot, ki je za vas ali otroka najustreznejši.
Clear glass syringe (type I glass) with stainless steel needle, rubber needle cover and plastic plunger.
50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Injekcijska brizga iz prozornega stekla (steklo tipa I) z iglo iz nerjavečega jekla, gumijastim pokrovčkom igle in plastičnim batom.