natgillin/translations-raw huggingface dataset:
Nearly 50% of reported deaths have been associated with infection.
Skoraj 50 % poročanih primerov smrtnega izida je bilo povezanih z okužbo.
Check that the solution is colourless to light yellow and opalescent.
Preverite, ali je raztopina brezbarvna do svetlo rumena in opalescentna.
In particular, tell your doctor if you are using any of the following medicines:
Še posebej povejte zdravniku, če uporabljate katero od naslednjih zdravil:
The potential contribution of exposure to infliximab and/or the severity of the underlying disease in these outcomes remains unclear.
Morebitni prispevek izpostavljenosti infliksimabu in/ali resnost obstoječe bolezni pri teh izidih ostajata nejasna.
• Blood test result showing ‘antibodies' against your own body.
• rezultati krvnih preiskav, ki kažejo "protitelesa" proti lastnemu telesu
List of other medicines:
Seznam ostalih zdravil:
(% of patients)
(% bolnikov)
• Eye problems, including red eyes and infections
• težave z očmi, vključno z rdečimi očmi in okužbami
Radiographic changes were assessed in IMPACT 2.
Spremembe na rentgenskih slikah so ocenjevali v študiji IMPACT2.
The median duration of response was 12 weeks.
Mediano trajanje odziva je bilo 12 tednov.
Fistula Response (%) Complete fistula response (%)
Odziv fistule (%) Popoln odziv fistule (%)
No serious infusion reactions were reported.
Resnih infuzijskih reakcij ni bilo.
In addition:
Poleg tega še:
• Severe allergic reaction that may cause loss of consciousness and could be life-threatening
• huda alergijska reakcija, ki lahko povzroči izgubo zavesti in je lahko življenjsko nevarna
Pregnancy and Vaccinations
Nosečnost in cepljenja
Telephone number doctor:
Telefonska številka zdravnika:
Reduction in CDAI ≥ 25% and ≥ 70 points.
Zmanjšanje CDAI na ≥ 25 % oziroma ≥ 70 točk.
In addition, bone fracture (6.8%) was reported, however, a causal association has not been established.
Dodatno so poročali o zlomu kosti (6,8 %), vendar vzročna povezava ni bila dokazana.
For more information see section on Pregnancy and breast-feeding.
Za več informacij glejte poglavje o Nosečnosti in dojenju.
These infections are caused by specific types of fungi that can affect the lungs or other parts of your body.
Te okužbe povzročajo posebne vrste gliv, ki lahko prizadenejo pljuča ali druge dele telesa.
The median terminal half-life at these doses ranged from 8 to 9.5 days.
Mediani končni razpolovni čas po teh odmerkih je znašal od 8 do 9,5 dni.
It is important that you and your doctor record the brand name and batch number of your medicine.
Pomembno je, da si vi in zdravnik zabeležita ime in številko serije vašega zdravila.
• The table below shows how often you will usually have this medicine after your first dose.
• V spodnji preglednici je prikazano, kako pogosto boste običajno prejemali to zdravilo po prvem odmerku.
Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Priporočljivo je periodično pregledovanje kože, predvsem pa za tiste bolnike z dejavniki tveganja za kožnega raka.
• In some patients receiving Remicade, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
• Pri nekaterih bolnikih, ki prejemajo zdravilo Remicade, telo morda ne bo tvorilo dovolj krvnih celic, ki pomagajo v boju proti okužbam ali pri zaustavljanju krvavitve.
(anaphylactic shock)
(anafilaktični šok)
Furthermore, a reduction in corticosteroid use and improvements in quality of life were observed.
Poleg tega so opazili tudi zmanjšanje uporabe kortikosteroidov in izboljšanje kakovosti življenja.
• in combination with methotrexate
• v kombinaciji z metotreksatom
Serious infections were reported in 12% (7/60) of all treated patients.
O resnih okužbah so poročali pri 12 % (7/60) vseh zdravljenih bolnikov.
If acute infusion reactions occur, the infusion must be interrupted immediately.
Če se pojavi akutna z infuzijo povezana reakcija, morate infuzijo takoj prekiniti.
In ASPIRE, more than 90% of patients had at least two evaluable X-rays.
V študiji ASPIRE je imelo več kot 90 % bolnikov najmanj dve uporabni rentgenski sliki.
Instructions for use and handling - storage conditions
Navodila za uporabo in ravnanje z zdravilom - pogoji shranjevanja
An allergic reaction could happen within 2 hours of your injection or later.
Alergijska reakcija lahko nastopi v času 2 ur po injekciji pa tudi kasneje.
* including bovine tuberculosis (disseminated BCG infection), see section 4.4
* vključno z bovino tuberkulozo (razsejano okužbo BCG), glejte poglavje 4.4
• Medicines that affect your immune system.
• Zdravila, ki vplivajo na vaš imunski sistem
All infusion reactions were mild or moderate in intensity.
Vse infuzijske reakcije so bile blage ali zmerne.
This evaluation should include colonoscopy and biopsies per local recommendations.
Med te teste sodijo na primer kolonoskopija in biopsije, v skladu z lokalnimi priporočili.
Use of live vaccines can result in clinical infections, including disseminated infections.
Uporaba živih cepiv lahko povzroči klinične okužbe, vključno z razsejanimi okužbami.
Patients with a PGA score ≥ 3 were eligible to receive an additional infusion of the same treatment at week 26.
Bolniki z oceno PGA ≥ 3 so lahko prejeli dodatno infuzijo iste terapije v 26. tednu.
Talk to your doctor if you are on a low salt diet.
Posvetujte se z zdravnikom, če ste na dieti z zmanjšanim vnosom soli.
ACR response (% of patients)
Odziv ACR (% bolnikov)
Week 26 All randomised patients
26. teden vsi randomizirani bolniki
Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2 IMPACT
Preglednica 9 Učinki na ACR in PASI v študijah IMPACT in IMPACT 2 IMPACT
These medicines may cause side effects.
Ta zdravila lahko povzročijo neželene učinke.
• Lack of interest or emotion
• pomanjkanje interesa ali čustev
The patient reminder card shall contain the following key messages:
Opozorilna kartica za bolnika mora vsebovati naslednja pomembna sporočila:
A low proportion of the infusion reactions was serious allergic reactions.
Majhen odstotek z infuzijo povezanih reakcij so predstavljale hude alergijske reakcije.
Write the new expiry date on the carton including day/month/year.
Na škatlo napišite novi rok uporabnosti, ki vključuje dan/mesec/leto.
There was no difference between groups in the number of late responders thereafter.
Potem ni bilo več nobene razlike med skupinama glede števila bolnikov s poznim odzivom.
Date of latest renewal: 2 July 2009.
Datum prve odobritve: 13. avgust 1999 Datum zadnjega podaljšanja: 2. julij 2009
Janssen Biotech Inc., 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, United States of America
Janssen Biotech Inc. 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, Združene države Amerike
If you have had a break in your Remicade treatment of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
Če ste prekinili zdravljenje z zdravilom Remicade za več kot 16 tednov, obstaja večje tveganje za pojav alergijskih reakcij ob ponovni uvedbi zdravljenja.
Discuss the use of contraception during this time with your doctor.
Glede uporabe kontracepcije med tem časom se posvetujte z zdravnikom.
All patients had a history of heavy smoking.
Vsi bolniki so imeli v anamnezi močno kajenje.
The available clinical experience is limited.
Na voljo je malo kliničnih izkušenj.
The interval between the last maintenance dose and the first re-induction dose ranged from 35-231 days.
Časovni razmik med zadnjim vzdrževalnim odmerkom zdravila in prvim odmerkom pri ponovni uporabi uvodne sheme je bil od 35 do 231 dni.
Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period.
Ker lahko izločanje infliksimaba traja do šest mesecev, morate bolnika spremljati ves ta čas.
It is used in adults for the following inflammatory diseases:
Uporablja se za zdravljenje naslednjih vnetnih bolezni pri odraslih:
After reconstitution and dilution:
Po rekonstituciji in redčenju:
• Cancer in children and adults
• rak pri otrocih in odraslih
The concomitant use of infliximab with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.
Sočasne uporabe infliksimaba s temi biološkimi zdravili ne priporočamo zaradi možnosti povečanega tveganja za okužbe in drugih možnih farmakoloških interakcij.
Remicade should only be used during pregnancy if your doctor feels it is necessary for you.
Zdravilo Remicade se lahko uporablja med nosečnostjo le, če zdravnik meni, da je to pri vas potrebno.
Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy.
Pri približno 3 % bolnikov so terapijo ustavili zaradi z infuzijo povezanih reakcij in vsi bolniki so okrevali, z ali brez medikamentozne terapije.
Infliximab should only be used during pregnancy if clearly needed.
Infliksimab se med nosečnostjo lahko uporablja le, če je nujno potrebno.
The new expiry date must be written on the carton.
Novi datum izteka roka uporabnosti je treba napisati na škatlo.
No further clinically relevant accumulation was observed.
Nadaljnjega klinično pomembnega kopičenja niso opažali.
• Tell your doctor if you have had treatment with Remicade in the past and are now starting Remicade treatment again.
• Povejte zdravniku, če ste se v preteklosti že zdravili z zdravilom Remicade in sedaj ponovno začenjate zdravljenje.
• Your doctor should test you for hepatitis B virus.
• Zdravnik vas mora testirati za virus hepatitisa B.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
V okviru razvrstitve po organskih sistemih so neželeni učinki razvrščeni po naslednjih kategorijah pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Shortened infusions at doses > 6 mg/kg have not been studied (see section 4.8).
Uporabe skrajšanih infuzij v odmerkih > 6 mg/kg niso proučevali (glejte poglavje 4.8).
Data about fistulas were derived from PCDAI scores.
Podatke o fistulah so pridobili iz ocen PCDAI.
• Reduce the signs and symptoms of your disease
• zmanjšanje znakov in simptomov vaše bolezni,
Specific studies of Remicade in elderly patients have not been conducted.
Specifične študije zdravila Remicade pri starejših bolnikih niso bile izvedene.
If you feel tired, dizzy, or unwell after having Remicade, do not drive or use any tools or machines.
Če se po prejemu zdravila Remicade počutite utrujeni ali se ne počutite dobro, ne smete voziti ali upravljati kakršnih koli orodij ali strojev.
• The doctor will decide your dose and how often you will be given Remicade.
• Zdravnik bo določil odmerek, ki ga boste prejemali, in kako pogosto ga boste prejemali.
Do not use Remicade if any of the above applies to you.
Ne uporabljajte zdravila Remicade, če menite, da se katero od zgoraj navedenih stanj nanaša na vas.
In this trial, sixty six percent of the patients (686 out of 1,040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1,040) received at least one shortened infusion of 60 minutes or less.
V tem preskušanju je 66 % bolnikov (686 od 1.040) prejelo najmanj eno skrajšano infuzijo v trajanju 90 minut ali manj, 44 % bolnikov (454 od 1.040) pa je prejelo najmanj eno skrajšano infuzijo v trajanju 60 minut ali manj.
Keep this card with you for 4 months after your dose of Remicade, or in case of pregnancy for at least 6 months after the birth of your baby.
To kartico nosite s seboj še 4 mesece po odmerku zdravila Remicade ali v primeru nosečnosti še vsaj 6 mesecev po rojstvu otroka.
• Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake "EXP".
Adult Crohn's disease Remicade is indicated for:
Crohnova bolezen pri odraslih bolnikih Remicade je indiciran za:
Remicade is also used in adults and children 6 years of age or older for:
Zdravilo Remicade se uporablja tudi za zdravljenje odraslih in otrok starih 6 let in več za:
Results from week 54 are shown in Table 4.
Rezultati za 54. teden so prikazani v Preglednici 4.
Prior therapy with PUVA, methotrexate, ciclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant.
Predhodno terapijo s PUVA, metotreksatom, ciklosporinom ali acitretinom je prejelo 71,4 % bolnikov čeprav ni nujno da so bili odporni na uvodno terapijo.
Post-marketing experience
Izkušnje iz obdobja trženja
What Remicade is and what it is used for
Kaj je zdravilo Remicade in za kaj ga uporabljamo
For women taking Remicade including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Ženskam, ki prejemajo zdravilo Remicade, vključno s starejšimi od 60 let, lahko zdravnik priporoči redne presejalne teste za raka materničnega vratu.
Between weeks 6 and 26, symptoms of psoriasis gradually returned with a median time to disease relapse of > 20 weeks.
Med 6. in 26. tednom so se simptomi psoriaze postopoma povrnili, mediana vrednost časa do ponovitve bolezni pa je bila > 20 tednov.
Side effects may occur a long time after your last dose.
Neželeni učinki se lahko pojavijo še dolgo časa po zadnjem odmerku zdravila.
In this situation, do not return to refrigerated storage again.
V tem primeru ga ne vračajte ponovno v hladilnik.
In P01522, improvement in signs and symptoms was also observed as early as week 2.
V študiji P01522 so tudi opazili izboljšanje znakov in simptomov bolezni že v 2. tednu.
• Changes in how your liver works, increase in liver enzymes (shown in blood tests)
• spremenjeno delovanje vaših jeter, povečanje vrednosti jetrnih encimov (pokaže se v izvidih krvnih preiskav)
Median time to loss of response through week 54
Mediana vrednost časa do izginotja odziva v obdobju do 54. tedna
• Remicade will be given to you by your doctor or nurse.
• Zdravilo Remicade vam bo dal zdravnik ali medicinska sestra.
• adult patients with active disease when the response to disease-modifying antirheumatic drugs
• pri odraslih bolnikih z aktivno boleznijo, kadar odziv na protirevmatična zdravila
The majority of the malignancies developed in the lung or head and neck.
Večina malignomov se je pojavila na pljučih ali na glavi in vratu.
After the first year of the study, 78 patients continued into an open-label extension to week 98.
Po prvem letu študije je 78 bolnikov nadaljevalo z odprtim podaljškom študije do 98. tedna.
Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Remicade can be re-administered within 16 weeks following the last infusion.
Ponovna uporaba zdravila pri Crohnovi bolezni in revmatoidnem artritisu Če se znaki in simptomi bolezni ponovijo, lahko zdravilo Remicade ponovno uporabite v roku 16 tednov po zadnji infuziji.
Failure to respond to treatment for Crohn's disease may indicate the presence of a fixed fibrotic stricture that may require surgical treatment.
Neodzivanje na zdravljenje pri Crohnovi bolezni lahko kaže na prisotnost stalne fibrozne strikture, zaradi katere bo morda potrebno kirurško zdravljenje.
All patients administered Remicade are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Vse bolnike, ki prejmejo zdravilo Remicade, je treba opazovati najmanj 1 do 2 uri po infuziji zaradi akutnih z infuzijo povezanih reakcij.
Key results are presented in Table 10.
Ključni izsledki so predstavljeni v Preglednici 10.
Remove flip-top from the vial and wipe the top with a 70% alcohol swab.
Odstranite ploščico na zaporki viale in njen vrh obrišite z zložencem, prepojenim s 70 % alkoholom.
Other paediatric indications
Druge pediatrične indikacije
It should be noted that in the majority of these reports tuberculosis was extrapulmonary, presenting as either local or disseminated disease.
Treba pa je poudariti, da so pri večini teh bolnikov tuberkulozo ugotovili zunaj pljuč in je šlo bodisi za lokalno ali razsejano bolezen.
Calculate the dose and the number of Remicade vials needed.
Izračunajte odmerek in število potrebnih vial zdravila Remicade.
Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Remicade treatment.
Ker pa se človeški imunoglobulini izločajo v materino mleko, matere ne smejo dojiti še najmanj 6 mesecev po zdravljenju z zdravilom Remicade.
• Tell your doctor if you have any heart problems, such as mild heart failure.
• Povejte zdravniku, če imate kakršne koli težave s srcem, kot na primer blago srčno popuščanje.
• Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
• nenormalne vrednosti beljakovine v krvi, imenovane faktor komplementa, ki je del imunskega sistema
Patients who have had their dose interval shortened to less than 8 weeks may be at greater risk for adverse reactions.
Pri bolnikih, ki so imeli razmik med odmerki skrajšan na manj kot 8 tednov, lahko obstaja večje tveganje za pojav neželenih učinkov.
If adequate response is achieved, patients should be continued on the selected dose or dose frequency.
Če dosežete zadosten odziv, naj bolnik nadaljuje z zdravljenjem z izbranim odmerkom in pogostnostjo odmerjanja.
• Inflammation in the eye that may cause changes in the vision, including blindness
• vnetje očesa, ki lahko povzroči spremembe vida, vključno s slepoto
The proportion of patients in clinical response at week 8 was 73.3% (44/60).
Delež bolnikov s kliničnim odzivom 8. teden je bil 73,3 % (44/60).
Cases of agranulocytosis have also been reported (see section 4.8).
Poročali so tudi o primerih agranulocitoze (glejte poglavje 4.8).
An infusion-related reaction was defined in clinical studies as any adverse event occurring during an infusion or within 1 hour after an infusion.
Z infuzijo povezana reakcija je bila opredeljena v kliničnih študijah kot katerikoli neželeni učinek, ki je nastopil med infuzijo ali 1 uro po infuziji.
• Difficult or painful breathing, chest pain
• težko ali boleče dihanje, bolečine v prsih
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Ta redka oblika limfoma celic T ima zelo agresiven potek bolezni, običajno s smrtnim izidom.
Concurrent use of stable doses of conventional therapies was permitted, and 83% of patients continued to receive at least one of these therapies.
Sočasna uporaba stalnih odmerkov konvencionalnih zdravil je bila dovoljena in 83 % bolnikov je še naprej prejemalo vsaj eno od teh terapij.
For storage conditions up to 25 °C before reconstitution of the medicinal product, see section 6.3.
Za pogoje shranjevanja do 25 °C pred rekonstitucijo zdravila glejte poglavje 6.3.
Overall proportions of adverse events and infusion reactions were similar between the 6 to 11 and 12 to 17 year age groups.
Celotni delež neželenih učinkov in infuzijskih reakcij je bil v starostni skupini od 6 do 11 let podoben kot v starostni skupini od 12 do 17 let.
Single doses up to 20 mg/kg have been administered without toxic effects.
Uporabljeni so bili enkratni odmerki infliksimaba do 20 mg/kg in ti niso povzročili toksičnih učinkov.
There is no evidence to suggest that infliximab worsens or causes fibrotic strictures.
Ni dokazov, da bi infliksimab poslabšal ali povzročil nastanek fibroznih striktur.
ACR 20 response* 5(10%) 34 (65%) 48 (62%) 16 (16%) 54 (54%) 53 (53%) ACR 50 response* 0(0%) 24 (46%) 35 (45%) 4 (4%) 41(41%) 33 (33%) ACR 70 response* 0(0%) 15 (29%) 27 (35%) 2 (2%) 27 (27%) 20 (20%) PASI response
Odziv ACR 20* 5(10 %) 34 (65 %) 48 (62 %) 16 (16 %) 54 (54 %) 53 (53 %) Odziv ACR 50* 0(0 %) 24 (46 %) 35 (45 %) 4 (4 %) 41(41 %) 33 (33 %) Odziv ACR 70* 0(0 %) 15 (29 %) 27 (35 %) 2 (2 %) 27 (27 %) 20 (20 %) Odziv PASI
• You are allergic to infliximab or to any of the other ingredients in Remicade (listed in section 6).
• če ste alergični na infliksimab ali katero koli sestavino zdravila Remicade (navedeno v poglavju 6),
Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino, druge glodalske beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
• It is recommended that when Remicade is prepared for infusion, it is used as soon as possible (within 3 hours).
• Priporočljivo je, da se pripravljeno raztopino za infuzijo zdravila Remicade uporabi čim prej (v 3 urah).
The efficacy of Remicade through week 54 was assessed in the ACT 1 study.
Učinkovitost zdravila Remicade do 54. tedna so ocenjevali v preskušanju ACT 1.
In vivo, infliximab rapidly forms stable complexes with human TNF, a process that parallels the loss of TNF bioactivity.
In vivo infliksimab hitro tvori stabilne komplekse s humanim TNF, ta proces pa poteka vzporedno z izgubo biološke aktivnosti TNF.
Forty six percent of patients continued on stable doses of methotrexate (≤ 25 mg/week).
46 % bolnikov je zdravljenje nadaljevalo s stalnimi odmerki metotreksata (≤ 25 mg/teden).
• Reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery.
• zmanjšanje števila nenormalnih odprtin (fistul), ki tvorijo povezavo med črevesjem in kožo, in ki jih niso odpravila druga zdravila ali kirurški poseg.
It is important that you tell your baby's doctors and other healthcare professionals about your Remicade use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Pomembno je, da zdravnike svojega otroka in druge zdravstvene delavce obvestite, da ste prejemali zdravilo Remicade, da bodo lahko presodili, kdaj sme vaš dojenček prejeti katero koli cepivo, vključno z živimi cepivi, kot je cepivo BCG (uporablja se za preprečevanje tuberkuloze).
After the first year of the study, 53 patients continued into an open-label extension to week 102.
Po prvem letu študije je skupaj 53 bolnikov nadaljevalo z odprtim podaljškom študije do 102. tedna.
Of the 573 patients randomised, 335 (58%) achieved clinical response by week 2.
Od 573 randomiziranih bolnikov jih je 335 (58 %) doseglo klinični odziv že v 2. tednu.
Antibodies to infliximab cannot always be detected in serum samples.
Protiteles na infliksimab ni vedno mogoče odkriti v vzorcih seruma.
Patients who did not respond to infliximab at week 8 (n = 15) received no further medicinal product and returned for safety follow-up.
Bolniki, ki se do 8. tedna niso odzvali na infliksimab (n = 15), niso več prejemali zdravila in so se vrnili na kontrolni pregled glede varnosti.
Key efficacy results for IMPACT and IMPACT 2 are shown in Table 9 below:
Ključni izsledki o učinkovitosti zdravila iz študij IMPACT in IMPACT 2 so prikazani v spodnji Preglednici 9:
The potential risk with the combination of AZA or 6-MP and Remicade should be carefully considered.
Natančno je treba pretehtati potencialno tveganje pri sočasnem dajanju AZA ali 6-MP z zdravilom Remicade.
Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections.
Okužba zgornjih dihal (7/60 [12 %]) in faringitis (5/60 [8 %]) sta bili najpogosteje zabeleženi okužbi dihal.
There are insufficient preclinical data to draw conclusions on the effects of infliximab on fertility and general reproductive function (see section 5.3).
Ni zadostnih predkliničnih podatkov, da bi lahko sklepali o učinkih infliksimaba na plodnost in splošno sposobnost razmnoževanja (glejte poglavje 5.3).
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Podatki, ki so na voljo, kažejo, da klinični odziv običajno dosežemo v 12 tednih zdravljenja.
Before reconstitution: 3 years at 2 °C - 8 °C.
Pred rekonstitucijo: 3 leta pri temperaturi 2 °C - 8 °C