natgillin/translations-raw huggingface dataset:
The following side effects have been observed with Remsima:
Pri uporabi zdravila Remsima so opazili naslednje neželene učinke:
Powder for concentrate for solution for infusion (powder for concentrate) The powder is white.
prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat).
Upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in clinical trials with infliximab, occurring in 25.3% of infliximab-treated patients compared with 16.5% of control patients.
Najpogostejši neželeni učinek zdravila, o katerem so poročali v kliničnih preskušanjih z infliksimabom, je bila okužba zgornjih dihal, ki se je pojavila pri 25,3 % bolnikov, zdravljenih z infliksimabom, in pri 16,5 % bolnikov iz kontrolne skupine.
• Ankylosing spondylitis (Bechterew's disease)
• Psoriatični artritis • Ankilozirajoči sponzilitis (Bechterew sindrom)
• The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to give your dose of Remsima over
• Zdravilo vam bodo dali v obliki infuzije (kapalne) (v času 2 ur) v eno od ven, običajno v roki.
Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Varnost in učinkovitost infliksimaba pri otrocih in mladostnikih, mlajših od 18 let, za indikacije juvenilni idiopatski artritis, psoriatični artritis in ankilozirajoči spondilitis nista bili dokazani.
EU/1/13/853/001 1 vial EU/1/13/853/002 2 vials EU/1/13/853/003 3 vials EU/1/13/853/004 4 vials EU/1/13/853/005 5 vials
EU/1/13/853/0011 viala EU/1/13/853/002 2 viali EU/1/13/853/003 3 viale EU/1/13/853/004 4 viale EU/1/13/853/005 5 vial
• You should avoid getting pregnant when you are being treated with Remsima and for 6 months after you stop being treated with it.
• Če prejemate zdravilo Remsima, je treba preprečiti nosečnost med zdravljenjem in še vsaj 6 mesecev po prenehanju zdravljenja.
About the Remsima syringe Parts of the syringe (see Figure A):
Informacije o peresniku Remsima Sestavni deli injekcijskega peresnika (glejte sliko A):
When starting a new card, please keep this card as a reference for 4 months after your last dose of Remsima.
Ko prejmete novo kartico, imejte to kartico pri sebi še 4 mesece po zadnjem odmerku zdravila Remsima.
Note: When the injection starts you will hear the 1st loud
Opomba: Ob začetku injiciranja boste zaslišali glasen prvi »klik«, nato pa boste skozi okence videli, kako olivno zelen bat brizge napreduje.
Insert the syringe into the injection site (see Figure E).
Injekcijsko brizgo položite na mesto injiciranja (glejte sliko E).
Pulmonary oedema, bronchospasm, pleurisy, pleural effusion
pljučni edem, bronhospazem, plevritis, plevralni izliv redki:
All randomised patients
Število randomiziranih bolnikov
Clinical Remission
KLINIČNI PODATKI
Remsima 120 mg solution for injection in pre-filled syringe or in pre-filled pen are administered by subcutaneous injection only.
Zdravilo Remsima 120 mg raztopina za injiciranje v napolnjeni injekcijski brizgi ali v napolnjenem injekcijskem peresniku se lahko aplicira samo s subkutanim injiciranjem.
• Cotton ball or gauze*
• Kosem vate ali gazo*
Transient visual loss occurring during or within 2 hours of infusion
prehodna izguba vida, ki nastopi med infundiranjem ali v roku 2 ur po infundiranju
• This medicine can also be stored in the original carton outside of refrigerated storage up to a maximum of 25°C for a single period of up to 14 days, but not beyond the original expiry date.
• To zdravilo se lahko shranjuje tudi v originalni škatli izven hladilnika do največ 25 °C za enkratno obdobje do 14 dni, vendar ne dlje od originalnega datuma izteka roka uporabnosti.
2 Number of patients evaluated for ALT. 3 Median follow-up is based on patients treated.
3 Mediana dolžine spremljanja bolnikov je bila določena samo z upoštevanjem zdravljenih bolnikov.
• Do not use the pen if it has been dropped or is visibly damaged.
• Injekcijski peresnika ne smete uporabiti, če je padel na tla ali če ima vidne znake poškodb.
• Signs of a heart problem such as chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea (feeling sick),
• znaki težav s srcem, na primer nelagodje ali bolečina v prsnem košu, bolečina v roki, bolečina v trebuhu, kratka sapa, tesnoba, vrtoglavica, omotica, omedlevica, potenje, siljenje na bruhanje
• Signs of a local injection site reaction such as redness, pain, itching, swelling, hardness, bleeding, bruising, cold sensation, irritation, tingling sensation, ulcer, hives, rash and scab.
• znaki lokalne reakcije na mestu injiciranja, kot so rdečica, bolečina, srbečica, oteklina, otrdelost, krvavitev, modrice, občutek hlada, draženje, občutek ščemenja, ulkus, koprivnica, izpuščaj in krasta.
Remsima is a solution that is clear to opalescent, colourless to pale brown.
Zdravilo Remsima je bistra do opalescentna in brezbarvna do bledo rjava raztopina.
There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation.
močno aktivno vnetno bolezen, je osnovno tveganje za limfom in levkemijo povečano, kar dodatno zaplete oceno tveganja.
At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118 and 277 micrograms/mL, respectively.
Cmaks 77, 118 in 277 mikrogramov/ml.
Paediatric ulcerative colitis patients
Pediatrični bolniki z ulceroznim kolitisom
Table 5 Effects on response and remission rate, data from ACCENT I (Week-2 responders)
Učinki na stopnjo odziva in ponovitev bolezni pri bolnikih; podatki iz študije ACCENT I
Rheumatoid arthritis1 1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
1 Bolniki iz placebo skupine so prejemali metotreksat, medtem ko so bolniki iz skupine infliksimab prejemali tako infliksimab kot metotreksat.
Tell your doctor straight away if you get signs of infection during treatment with Remsima.
Zdravniku takoj povejte, če ste dobili simptome okužbe med zdravljenjem z zdravilom Remsima.
Remsima may be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months, but not exceeding the original expiry date.
Zdravilo Remsima se lahko shranjuje pri temperaturah do največ 25°C za enkratno obdobje do 6 mesecev, vendar ne dlje od originalnega datuma izteka roka uporabnosti.
(anaphylactic shock)
(hepatosplenični limfom T celic)
Remsima 120 mg injection infliximab
Remsima 120 mg injekcija infliksimab s.c.
Do not use if the solution is cloudy, discoloured or contains visible particulate matter.
Raztopine ne smete uporabiti, če je motna, razbarvana ali če so prisotni neprosojni delci.
Clinical Responsea Clinical Remission Steroid-Free Remission
Remisija brez jemanja steroidov
Cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of infliximab.
V obdobju trženja so opazili primere zlatenice in neinfekcijskega hepatitisa in nekateri od njih so imeli značilnosti avtoimunskega hepatitisa.
Remsima is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Ulcerozni kolitis pri pediatričnih bolnikih Zdravilo Remsima je indicirano za zdravljenje močno aktivnega ulceroznega kolitisa pri otrocih in mladostnikih, starih od 6 do 17 let, ki so se nezadostno odzvali na običajno zdravljenje, na primer na kortikosteroide in 6-MP ali AZA, ter pri tistih, ki ne prenašajo takšnega zdravljenja ali imajo medicinske kontraindikacije zanj.
• This medicine can also be stored in the original carton outside of refrigerated storage up to a maximum of 25°C for a single period of up to six months, but not beyond the original expiry date.
• To zdravilo se lahko shranjuje tudi v originalni škatli izven hladilnika do največ 25 °C za enkratno obdobje do 6 mesecev, vendar ne dlje od originalnega datuma izteka roka uporabnosti.
Each pack contains 1 pre-filled syringe with automatic needle guard with 2 alcohol pads, 2 pre-filled syringes with automatic needle guard with 2 alcohol pads or 4 pre-filled syringes with automatic needle guard with 4 alcohol pads.
Eno pakiranje vsebuje 1 napolnjeno injekcijsko brizgo s samodejnim ščitnikom za iglo z 2 alkoholnima zložencema, 2 napolnjeni injekcijski brizgi s samodejnim ščitnikom za iglo z 2 alkoholnima zložencema ali 4 napolnjene injekcijske igle s samodejnim ščitnikom za iglo s 4 alkoholnimi zloženci.
The incidence of localised injection site reactions (e.g. injection site erythema, pain, pruritus and swelling) was 17.6 per 100 patient-years in the Remsima subcutaneous group (from Week 6) and 21.4 per 100 patient-years in those who switched to Remsima subcutaneous administration (from Week 30).
V skupini, ki je prejemala zdravilo Remsima v subkutani obliki (od 6. tedna naprej), je bila pojavnost lokalnih reakcij na mestu injiciranja (npr. eritem na mestu injiciranja, bolečina, pruritus in oteklina) 17,6 na 100 bolnikov-let in 21,4 na 100 bolnikov-let v skupini, ki je prešla na zdravilo
Do not rub the injection site.
Mesta injiciranja ne smete drgniti.
• Alcohol swab
• alkoholni zloženec
• Remsima 120 mg solution for injection is administered by injection under the skin (subcutaneous use) only.
• Zdravilo Remsima 120 mg raztopina za injiciranje se daje izključno z injiciranjem pod kožo
Data to support dose titration in rheumatoid arthritis come from ATTRACT, ASPIRE and the START study.
Podatki, ki govorijo v prid titraciji odmerka pri revmatoidnem artritisu, so bili zbrani v študijah
Note: Rotate the injection site each time you give an injection.
Opomba: Za vsako injiciranje izberite drugo mesto injiciranja.
In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
Sočasna uporaba zaviralcev TNF-alfa in abatacepta V kliničnih študijah je bila sočasna uporaba zaviralcev TNF in abatacepta povezana z večjim tveganjem za okužbe (vključno z resnimi okužbami) kot pa uporaba samih zaviralcev TNF, čeprav ni prišlo do povečanja kliničnega učinka.
Week 50 a p <0.001, for each infliximab treatment group vs. control.
50. teden a p < 0,001 za vsako terapevtsko skupino, ki je prejemala infliksimab, v primerjavi s kontrolno skupino b n = 292
• Side effect due to an injection
• neželeni učinek zaradi injekcije • bolečine.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Remsima.
Če niste prepričani, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom ali farmacevtom, preden boste prejeli zdravilo Remsima.
Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Remsima.
Zdravniku povejte takoj, če se pojavijo simptomi nevrološke bolezni med zdravljenjem z zdravilom Remsima.
Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Remsima.
Zdravniku povejte takoj, če se med zdravljenjem z zdravilom Remsima pojavijo novi znaki srčnega popuščanja ali se obstoječi znaki poslabšajo.
• Tell your doctor if you have an infection even if it is a very minor one.
Zdravniku povejte, če imate kakršno koli, tudi najmanjšo okužbo.
After reconstitution one ml contains 10 mg of infliximab.
Po rekonstituciji en ml vsebuje ml 10 mg infliksimaba.
Remsima 100 mg powder for concentrate for solution for infusion
Remsima 100 mg prašek za koncentrat za raztopino za infundiranje
Remsima is a clear to opalescent, colourless to pale brown solution which is supplied as a single use pre-filled syringe.
Zdravilo Remsima je bistra do opalescentna in brezbarvna do bledo rjava raztopina, ki je na voljo v napolnjeni injekcijski brizgi za enkratno uporabo.
Tachycardia, palpitation
tahikardija, palpitacije občasni:
Note: Keep the pen and sharps disposal container out of the sight and reach of children.
Opomba: Injekcijsko brizgo in vsebnik za ostre odpadke shranite nedosegljiva otrokom.
In rheumatoid arthritis, psoriatic arthritis and Crohn's disease patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies against infliximab and increases the plasma concentrations of infliximab.
psoriatičnim artritisom in Crohnovo boleznijo lahko zmanjša tvorbo protiteles proti infliksimabu in poveča koncentracijo infliksimaba v plazmi.
The primary endpoints were the reduction of signs and symptoms as assessed by the ACR criteria (ACR20 for ATTRACT, landmark ACR-N for ASPIRE), the prevention of structural joint damage, and the improvement in physical function.
ACR) (ACR 20 za ATTRACT, mejna vrednost ACR-N za ASPIRE), preprečevanje strukturne okvare sklepov in izboljšanje njihove funkcije.
Remsima should be visually inspected for particulate matter or discolouration prior to administration.
Zdravilo Remsima morate pred uporabo vizualno pregledati, da ugotovite, ali vsebuje delce in ali je obarvano.
PGA of cleared (0) or minimal (1)
≥ 50 % izboljšanje PGA brez plakov (0) ali minimalni (1)
Remove the cap (see Figure D).
Snemite pokrovček (glejte sliko D).
EU/1/13/853/012 1 pre-filled pen EU/1/13/853/013 2 pre-filled pens EU/1/13/853/014 4 pre-filled pens
EU/1/13/853/012 1 napolnjen injekcijski peresnik EU/1/13/853/013 2 napolnjena injekcijska peresnika EU/1/13/853/014 4 napolnjeni injekcijski peresniki
Do not blow on or touch the injection site again before giving the injection.
Pred injiciranjem na mesto injiciranja ne smete pihati ali se ga dotikati.
Each pack contains 1 pre-filled syringe with 2 alcohol pads, 2 pre-filled syringes with 2 alcohol pads or 4 pre-filled syringes with 4 alcohol pads.
Vsako pakiranje vsebuje 1 napolnjen injekcijski peresnik z 2 alkoholnima zložencema, 2 napolnjena peresnika z 2 alkoholnima zložencema ali 4 napolnjene injekcijske peresnike s 4 alkoholnimi zloženci.
If you are not sure if any of the above applies to you, talk to your doctor before you are given Remsima.
Če niste prepričani, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom, preden boste prejeli zdravilo Remsima.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PRE-FILLED SYRINGE WITH AUTOMATIC NEEDLE GUARD
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA ZA NAPOLNJENO INJEKCIJSKO BRIZGO S SAMODEJNIM
• Rotate the injection site each time you give an injection.
• Za vsako injiciranje izberite drugo mesto injiciranja.
Acute reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following administration of infliximab.
v nekaj sekundah) ali v roku nekaj ur po uporabi infliksimaba.
Remove the syringe from the injection site (see Figure G).
Injekcijsko brizgo izvlecite iz mesta injiciranja (glejte sliko G).
Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis
perforacija črevesja, stenoza črevesja, divertikulitis,
Remsima 120 mg solution for injection in pre-filled syringe Each 1 mL single dose pre-filled syringe contains 120 mg of infliximab*.
Remsima 120 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 1-ml enoodmerna napolnjena injekcijska brizga vsebuje 120 mg infliksimaba*.
Re-administration for rheumatoid arthritis
Ponovna uporaba zdravila pri revmatoidnem artritisu
Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab.
Pri bolnikih, ki so prejemali infliksimab, so opažali tuberkulozo, bakterijske okužbe, vključno s sepso in pljučnico, invazivne glivične, virusne in druge oportunistične okužbe.
• Tell your doctor straight away if you get symptoms of liver problems during treatment with Remsima.
• Takoj obvestite zdravnika, če se med zdravljenjem z zdravilom Remsima pojavijo simptomi težav z jetri.
Remsima 100 mg powder for concentrate infliximab
Remsima 100 mg prašek za koncentrat infliksimab i.v.
New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
novo nastala in poslabšana psoriaza, vključno s pustulozno psoriazo (predvsem na dlaneh in podplatih), urtikarija,
Invasive fungal infections may present as disseminated rather than localised disease, and antigen and antibody testing may be negative in some patients with active infection.
poleg tega pa sta lahko pri nekaterih bolnikih z aktivno okužbo testa na antigen in protitelesa negativna.
Fistulising, active Crohn's disease
Vzdrževalno zdravljenje pri aktivni Crohnovi bolezni s fistulami
Patients should be tested for HBV infection before initiating treatment with infliximab.
Pred začetkom zdravljenja z infliksimabom, morate bolnike testirati na okužbo z virusom hepatitisa B
The mean terminal half-life ranged from 11.3 days to 13.7 days for 120, 180 and 240 mg of subcutaneous infliximab administered to healthy subjects.
Končni razpolovni čas 120-, 180- in 240-mg odmerka subkutanega infliksimaba, ki so bili dani zdravim preiskovancem, se je gibal v razponu od 11,3 dni do 13,7 dni.
Although subcutaneous administration is not indicated for children under age of 18 years, it should be noted that malignancies, some fatal, have been reported among children, adolescents and young adults
Čeprav pri otrocih, mlajših od 18 let, ni indicirana subkutana aplikacija, je treba upoštevati, da so pri otrocih, mladostnikih in mlajših odraslih (do 22 let starosti), ki so se zdravili z zaviralci TNF (začetek zdravljenja je bil pri starosti ≤ 18 let), vključno z infliksimabom, v obdobju trženja poročali o pojavu malignomov, od katerih so bili nekateri smrtni.
The primary endpoint of the study was corticosteroid-free clinical remission at week 26, defined as patients in clinical remission (CDAI of <150) who, for at least 3 weeks, had not taken oral systemic corticosteroids (prednisone or equivalent) or budesonide at a dose >6 mg/day.
< 150), ki najmanj 3 tedne niso jemali peroralnih sistemskih kortikosteroidov (prednizona oziroma njemu enakovrednih kortikosteroidov) ali budezonida v odmerku > 6 mg/dan.
Subcutaneous use
(subkutana uporaba).
Week 22
6. teden 22. teden
Discontinuation of infliximab therapy should be considered in patients with confirmed significant haematologic abnormalities.
Pri bolnikih s potrjenimi bistvenimi hematološkimi anomalijami lahko tudi ukinete zdravljenje z infliksimabom.
EU/1/13/853/006 1 pre-filled syringe EU/1/13/853/009 1 pre-filled syringe with automatic needle guard EU/1/13/853/007 2 pre-filled syringes EU/1/13/853/010 2 pre-filled syringes with automatic needle guard EU/1/13/853/008 4 pre-filled syringes EU/1/13/853/011 4 pre-filled syringes with automatic needle guard
EU/1/13/853/006 1 napolnjena injekcijska brizga EU/1/13/853/009 1 napolnjena injekcijska brizga s samodejnim ščitnikom za iglo EU/1/13/853/007 2 napolnjeni injekcijski brizgi
How to store Remsima
Shranjevanje zdravila Remsima
Remsima 100 mg powder for concentrate for solution for infusion infliximab
Remsima 100 mg prašek za koncentrat za raztopino za infundiranje infliksimab
The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, sarcoidosis/sarcoid-like reaction, and serious infusion reactions (see section 4.4).
TNF povezane neželene učinke zdravila, o katerih so poročali pri uporabi infliksimaba, sodijo reaktivacija HBV, kongestivno srčno popuščanje (CHF - Congestive Heart Failure), resne okužbe (vključno s sepso, oportunističnimi okužbami in TB), serumska bolezen (zapoznele preobčutljivostne reakcije), hematološke reakcije, sistemski eritematozni lupus/lupusu podoben sindrom,
The efficacy of subcutaneous infliximab in rheumatoid arthritis patients was assessed in a randomised, parallel-group pivotal Phase I/III study consisting of two parts: Part 1 to determine the optimal dose of subcutaneous infliximab and Part 2 to demonstrate non-inferiority in terms of efficacy of subcutaneous infliximab compared to intravenous infliximab treatment.
del je bil namenjen ugotavljanju optimalnega odmerka subkutanega infliksimaba, 2. del pa dokazovanju enakovrednosti z vidika učinkovitosti subkutanega infliksimaba v primerjavi z intravenskim infliksimabom.
Localised injection site reactions predominantly of mild to moderate in nature included the following reactions limited to injection site: erythema, pain, pruritus, swelling, induration, haematoma, oedema, bruising, coldness, irritation, paraesthesia, ulcer, urticaria, haemorrhage, rash and scab were reported to be associated with infliximab subcutaneous treatment.
V povezavi s subkutanim zdravljenjem z infliksimabom so poročali o lokalnih reakcijah na mestu injiciranja, ki so pretežno blage do zmerne, vključno z naslednjimi reakcijami, ki so omejene na mesto injiciranja: eritem, bolečina, pruritus, oteklina, zatrdlina, hematom, edem, modrica, občutek hladu,
Remsima 120 mg solution for injection in pre-filled syringe Remsima 120 mg solution for injection in pre-filled pen
Remsima 120 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Remsima 120 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Solution for injection 1 pre-filled pen with 2 alcohol pads 2 pre-filled pens with 2 alcohol pads 4 pre-filled pens with 4 alcohol pads
1 napolnjen injekcijski peresnik z 2 alkoholnima zložencema 2 napolnjena injekcijska peresnika z 2 alkoholnima zložencema 4 napolnjeni injekcijski peresniki s 4 alkoholnimi zloženci
In a 1-year clinical study with repeated infusions in patients with Crohn's disease (ACCENT I study), the incidence of serum sickness-like reactions was 2.4%.
ACCENT I), je bila incidenca reakcij, podobnih serumski bolezni, 2,4 %.
Once you remove the cap, do not recap the syringe.
Ko enkrat odstranite pokrovček z injekcijske brizge, ga ne smete več namestiti.
Fewer subjects underwent colectomy in the 5 mg/kg infliximab group (28/242 or 11.6% [N.S.]) and the 10 mg/kg infliximab group (18/242 or 7.4% [p=0.011]) than in the placebo group
Ugotovili so, da je bilo treba v terapevtskih skupinah, ki sta prejemali po 5 mg/kg infliksimaba (28/242 ali 11,6 % [nesignifikantno]) oziroma po 10 mg/kg infliksimaba
Under aseptic conditions, each Remsima vial should be reconstituted with 10 mL of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle.
Uporabite injekcijsko brizgo z iglo 0,8 mm (21 G) ali tanjšo.
Do not reuse the pen in this case.
tem primeru ga ne vračajte ponovno v hladilnik.
Remsima contains the active substance infliximab.
Zdravilo Remsima vsebuje učinkovino infliksimab.
Each new injection site should be at least
Vsako novo mesto injiciranja mora biti od prejšnjega oddaljeno vsaj 3 cm.
(up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤18 years of age),
Pri otrocih, mladostnikih in mlajših odraslih (do 22 let starosti), ki so se zdravili z zaviralci TNF
In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab intravenous administration (see section 4.4).
V okviru izkušenj v obdobju trženja je bila uporaba intravenskega infliksimaba povezana s primeri anafilaktoidnih reakcij, vključno z edemom grla ali žrela in hudega bronhospazma, ter epileptičnimi napadi (glejte poglavje 4.4).
Figure A
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