natgillin/translations-raw huggingface dataset:
Refer to the Hemlibra “Instructions for Use” for handling instructions when combining vials in a syringe.
Za navodila za ravnanje v primeru uporabe vsebine več vial v eni brizgi glejte "Navodila za uporabo"
● Followed by a maintenance dose of either 1.5 mg/kg once weekly, 3 mg/kg every two weeks or 6 mg/kg every four weeks, from week 5 on: Patient bodyweight (kg) x dose (1.5; 3 or 6 mg/kg) = total amount (mg) of emicizumab to be administered
● Sledi vzdrževalni odmerek bodisi 1,5 mg/kg enkrat na teden, 3 mg/kg enkrat na dva tedna ali 6 mg/kg enkrat na štiri tedne od 5. tedna naprej:
If you are not sure, talk to your doctor, pharmacist or nurse before using Hemlibra.
Če ste negotovi, se pred začetkom uporabe zdravila Hemlibra posvetujte z zdravnikom,
Stop using Hemlibra and aPCC, and talk to a doctor immediately if you or your caregiver notices any symptoms of thrombotic microangiopathy.
Če vi ali vaš skrbnik opazite kateri koli simptom trombotične mikroangiopatije, nemudoma prenehajte uporabljati zdravilo Hemlibra in aPCC in se nemudoma posvetujte z zdravnikom.
Other objectives of the study included evaluation of the randomized comparison of Arms A or B and Arm C for the efficacy of Hemlibra prophylaxis in reducing the number of all bleeds, spontaneous bleeds, joint bleeds, and target joint bleeds (see Table 4), as well as assessing patient treatment preference using a preference survey.
Hemlibra, kar zadeva zmanjšanje števila vseh krvavitev, spontanih krvavitev, krvavitev v sklepe in krvavitev v tarčne sklepe (glejte preglednico 4), ter ocena bolnikove preference glede zdravljenja na podlagi ankete o preferenci.
● To calculate the volume to be administered divide calculated dose 180 mg by 150 mg/mL: 180 mg of emicizumab ÷ 150 mg/mL = 1.20 mL of 150 mg/mL Hemlibra concentration to be injected.
● Za izračun potrebnega volumna delite izračunani odmerek 180 mg s 150 mg/ml: 180 mg emicizumaba ÷ 150 mg/ml = 1,20 ml je volumen zdravila Hemlibra s koncentracijo 150 mg/ml, ki ga je treba injicirati
● Keep the needle in the vial and turn the vial upside down.
● Medtem ko je igla v viali, obrnite vialo na glavo.
The physician should immediately discontinue aPCC and interrupt Hemlibra therapy if clinical symptoms, imaging, and/or laboratory findings consistent with thrombotic events occur, and manage as clinically indicated.
V primeru pojava kliničnih simptomov, slikovnih preiskav in/ali laboratorijskih izvidov, skladnih s trombotičnimi dogodki, mora zdravnik nemudoma prenehati uporabljati aPCC, prekiniti zdravljenje z zdravilom Hemlibra in stanje obravnavati, kot je klinično ustrezno.
● Push and twist the injection needle clockwise onto the syringe until it is fully attached.
● Potisnite iglo za injiciranje na brizgo in jo zasučite v smeri urnega kazalca, dokler ni povsem nameščena.
The primary objective of the study was to evaluate, among patients previously treated with episodic (“on-demand”) bypassing agents, the treatment effect of weekly Hemlibra prophylaxis compared with no prophylaxis (Arm A vs.
Primarni cilj študije je bil med bolniki, predhodno občasno (po potrebi) zdravljenimi z obvodnimi zdravili, oceniti učinek zdravljenja tedenske profilakse z zdravilom Hemlibra v primerjavi z obravnavo brez profilakse (skupina A v primerjavi s skupino B) na število krvavitev, ki so zahtevale zdravljenje s koagulacijskimi faktorji skozi čas (najmanj 24 tednov ali do datuma prenehanja) (glejte preglednico 6).
● To calculate the volume to be administered divide calculated dose 120 mg by 150 mg/mL: 120 mg of emicizumab ÷ 150 mg/mL = 0.8 mL of 150 mg/mL Hemlibra concentration to be injected every two weeks.
● Za izračun potrebnega volumna delite izračunani odmerek 120 mg s 150 mg/ml: 120 mg emicizumaba ÷ 150 mg/ml = 0,8 ml je volumen zdravila Hemlibra s koncentracijo 150 mg/ml, ki ga je treba injicirati na dva tedna
● 18G Transfer Needle Note: If you need to use more than 1 vial to inject your prescribed dose, you must use a new transfer needle for each vial.
● Alkoholnih lističev Opomba: Če morate za predpisani odmerek uporabiti več kot 1 vialo,
● Inspect the supplies for damage.
● Preglejte material in se prepričajte, da ni poškodovan.
Information on assays and methods not affected by emicizumab that may be used to monitor coagulation parameters during treatment, with specific considerations for FVIII chromogenic activity assays;
Informacije o testih in metodah, na katere emicizumab ne vpliva in se lahko uporabljajo za spremljanje koagulacijskih parametrov med zdravljenjem, s specifičnim upoštevanjem značilnosti kromogenih testov aktivnosti faktorja VIII; Navedba laboratorijskih testov, na katere emicizumab ne vpliva;
Each mL of solution contains 30 mg of emicizumab* Each vial of 1 mL contains 30 mg of emicizumab at a concentration of 30 mg/mL.
Ena 1-ml viala vsebuje 30 mg emicizumaba v koncentraciji 30 mg/ml.
Treated bleeds ABR (95% CI)
bMediani ABR (IQR) % z 0 krvavitvami (95-% IZ)
Hemlibra contains the active substance “emicizumab”.
Zdravilo Hemlibra vsebuje učinkovino emicizumab.
Table 14 Mean (± SD) steady-state emicizumab concentrations
Povprečna (± SD) koncentracija emicizumaba v stanju dinamičnega ravnovesja
● Peel off back to open the blister pack.
● Da odprete pretisni omot, odstranite njegov hrbtni del.
Transfer Needle
OVOJNINAH VIALA
● Keep this leaflet.
● Navodilo shranite.
Storing Hemlibra vials, vial adapters, needles and syringes: ● Keep the vial in the original box to protect the medicine from light.
Shranjevanje vial, adapterjev za viale, igel in brizg zdravila Hemlibra:
Vascular disorders
varnostni ščitnik pokrovček
● Loading dose (3 mg/kg) once weekly for the first 4 weeks: Patient bodyweight (kg) x dose (3 mg/kg) = total amount (mg) of emicizumab to be administered
Bolnikova telesna masa (kg) x odmerek (3 mg/kg) = celotna količina (mg) emicizumaba, ki jo je treba uporabiti
Treated bleeds ABR (95% CI) % reduction (RR), p-value
Zdravljene krvavitve ABR (95-% IZ) % zmanjšanje (RR), vrednost p neaplikabilno
Arm A: 1.5 mg/kg Hemlibra weekly
Skupina A: 1,5 mg/kg zdravila Hemlibra na teden n = 18
Keeping a record
Vodenje evidence
● To calculate the volume to be administered divide calculated dose 120 mg by 150 mg/mL: 120 mg of emicizumab ÷ 150 mg/mL = 0.8 mL of 150 mg/mL Hemlibra concentration to be injected.
● Za izračun potrebnega volumna delite izračunani odmerek 120 mg s 150 mg/ml: 120 mg emicizumaba ÷ 150 mg/ml = 0,8 ml je volumen zdravila Hemlibra s koncentracijo 150 mg/ml, ki ga je treba injicirati
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija zelo pogosti mialgija pogosti
● blood clot in a vein behind your eye (cavernous sinus thrombosis)
● propadanje rdečih krvnih celic (trombotična mikroangiopatija) ● krvni strdek v veni za očesom (tromboza kavernoznega sinusa)
ABR= Annualised Bleed Rate; CI= confidence interval; RR= rate ratio; IQR=interquartile range, 25th percentile to 75
ABR = na leto preračunani delež krvavitev (annualized bleed rate), IZ = interval zaupanja, RR = razmerje deležev (rate ratio), IQR = kvartilni razpon (interquartile range) (od 25. do 75. percentila)
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of 150 mg/mL.
Ena viala z 0,4 ml vsebuje 60 mg emicizumaba v koncentraciji 150 mg/ml.
● With the syringe pointing upwards, slowly pull back the plunger to fill the syringe with more than the amount of medicine needed for your prescribed dose.
● Počasi izvlecite bat, da boste brizgo napolnili s količino zdravila, večjo od potrebne za predpisani odmerek.
Effects of emicizumab on coagulation tests
Testi, na katere emicizumab vpliva
Reminder to report any adverse events associated with the use of emicizumab.
Opomnik za poročanje o vseh neželenih dogodkih, povezanih z uporabo emicizumaba ● Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila:
ABR (95% CI) % reduction (RR), p-value
Mediani ABR (IQR) % zmanjšanja (RR), vrednost p
PREPARATION Step 1.
Preglednica 1.
● Throw away any used caps, vial(s), needles and syringes in a sharps or puncture-proof container.
● Vse uporabljene pokrovčke, viale, igle in injekcijske brizge zavrzite v vsebnik za ostre odpadke oziroma vsebnik, odporen proti prebadanju.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/004
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1271/004
Each vial of Hemlibra contains 30 mg (1 mL at a concentration of 30 mg/mL) of emicizumab.
Ena viala zdravila Hemlibra vsebuje 30 mg (1 ml s koncentracijo
● Push and twist the transfer needle clockwise on to the syringe until it is fully attached.
● Potisnite iglo za prenos na brizgo in jo zasučite v smeri urnega kazalca, dokler ni povsem nameščena.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1271/002
● Once removed from the refrigerator, the unopened vial can be kept at room temperature for up to 7 days After storage at room temperature unopened vials may be returned to the refrigerator.
● Potem, ko vialo vzamete iz hladilnika, je lahko neodprta viala shranjena na sobni temperaturi do
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1271/001
How to store Hemlibra
Shranjevanje zdravila Hemlibra
ABR=Annualized Bleed Rate, CI=confidence interval; IQR=interquartile range; 25th percentile to 75th percentile
ABR = na leto preračunani delež krvavitev (annualized bleed rate), IZ = interval zaupanja, IQR = kvartilni razpon (od 25. do 75. percentila)
- Treating physicians must carefully weigh the risk of TMA and thromboembolism against the risk of bleeding when considering aPCC treatment.
- Uporabi aPCC se je treba izogibati, razen če ni na voljo nobenih drugih možnosti zdravljenja/alternativ, in v primeru, da je aPCC edina možnost, upoštevati priporočila za odmerjanje aPCC; - Pri odločanju za zdravljenje z aPCC mora lečeči zdravnik skrbno pretehtati tveganje za TMA in trombembolijo v primerjavi s tveganjem za krvavitve.
Tabulated list of adverse drug reactions
predhodna profilaksa z obvodnim zdravilom
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1271/003
Stop using Hemlibra and aPCC, and talk to a doctor immediately if you or your caregiver notices any symptoms of blood clots in blood vessels.
Če vi ali vaš skrbnik opazite kateri koli simptom krvnih strdkov v žilah, nemudoma prenehajte uporabljati zdravilo Hemlibra in aPCC in se nemudoma posvetujte z zdravnikom.
Connect syringe to vial adapter
Na adapter za vialo namestite brizgo
Step A. Recap transfer needle
Korak A. Namestite pokrovček nazaj na iglo za prenos
Relevant information (e.g. seriousness, severity, frequency, time to onset, reversibility as applicable) of the following safety concerns associated with the use of Hemlibra: - thromboembolic events associated with the concomitant use of emicizumab and activated prothrombin complex concentrate (aPCC), - thrombotic microangiopathy associated with the concomitant use of emicizumab and aPCC - life-threatening bleeding due to misinterpretation of the standard coagulation tests
Informacije o resnih, življenje ogrožajočih trombemboličnih dogodkih ali dogodkih trombotične mikroangiopatije, ki so jih opazili pri sočasni uporabi emicizumaba s koncentratom aktiviranega protrombinskega kompleksa (aPCC) pri bolnikih, zdravljenih z emicizumabom;
● Do not use the vial if: the medicine is cloudy, hazy or coloured.
če je zdravilo motno, megličasto ali obarvano.
Each mL of solution contains 150 mg of emicizumab* Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of 150 mg/mL.
* Ena 0,4-ml viala vsebuje 60 mg emicizumaba v koncentraciji 150 mg/ml.
240 ml (10 mg/ml) 1 bottle + 1 syringe + 1 adapter
1 steklenica + 1 brizga + 1 adapter
Strength Pharmaceutical form Route of administration
Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina (koncentracija)
Wait 30 minutes for medication to warm.
Počakajte 30 minut, da se zdravilo ogreje.
First read all the instructions carefully and then follow them step by step.
Najprej natančno preberite navodilo v celoti, nato pa ga korak za korakom upoštevajte.
Median Time to Failure (months)
Mediana časa do neuspeha (meseci)
Not known (frequency cannot be estimated from available data):
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
• Wash your hands with soap and water, then dry them completely.
• Roke si umijte z milom in vodo, nato jih popolnoma osušite.
Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
• DO NOT attempt to self-inject until you are sure that you understand how to prepare and give the
• Injekcije si NE poskušajte dati sami, dokler niste prepričani, da razumete, kako je treba injekcijo pripraviti in dati.
• It is normal to see one or more bubbles in the medication.
• Prisotnost enega ali več mehurčkov v zdravilu je normalna.
Tell your doctor as soon as possible, if you notice any of the following:
Čim prej obvestite zdravnika, če opazite kaj od naslednjega:
• If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na adalimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• Physician educational material • Patient information
• izobraževalno gradivo za zdravnike • informacije za bolnike
Tuberculosis can develop during therapy even if you have received preventative treatment for tuberculosis.
Tuberkuloza se lahko razvije med zdravljenjem, tudi če ste bili preventivno zdravljenji za tuberkulozo.
Detailed instructions on how to inject Cyltezo are provided in section 7 ‘Instructions for use'.
Podrobna navodila o injiciranju zdravila Cyltezo so v poglavju 7 ‘Navodila za uporabo'.
This may cause severe allergic reactions in patients sensitive to latex.
Ta lahko povzroča hude alergijske reakcije pri bolnikih, občutljivih na lateks.
Injecting medication that is cold can cause discomfort.
Injiciranje hladnega zdravila lahko povzroči neugodje.
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not
• Glede na študije v nosečnosti ni bilo večjega tveganja za defekte ob rojstvu, če je mati jemala adalimumab med nosečnostjo, v primerjavi z materami z enako boleznijo, ki adalimumaba niso jemale.
• Signs or symptoms of the safety concern and when to seek attention from a HCP
• Znake ali simptome varnostnih pomislekov in kdaj je treba poiskati pomoč zdravstvenega
There may be a need for dose interruption, for instance before surgery or if a serious infection occurs.
Morda bo potrebno uporabo prekiniti, npr. pred operacijo ali če se pojavi resna okužba.
The primary endpoint was the birth prevalence of major birth defects.
Primarni opazovani dogodek je bila prevalenca rojstev z večjmi defekti ob rojstvu.
• A warning message for HCPs treating the patient at any time, including in conditions of emergency,
• Opozorilo za zdravstvene delavce, ki bolnika kadar koli zdravijo, vključno v nujnih primerih,
• DO NOT remove cap until right before injection (step 6).
• Pokrovček odstranite tik pred injiciranjem (6. korak).
Because the elimination of adalimumab may take up to four months, monitoring should be continued throughout this period.
Ker lahko izločanje adalimumaba traja do štiri mesece, je treba bolnike ves ta čas nadzirati.
• If you have a severe infection, including tuberculosis (see “Warnings and precautions”).
• če imate hudo okužbo, vključno s tuberkulozo (glejte "Opozorila in previdnostni ukrepi").
• Select an area on the upper thighs or abdomen/belly (at least 5 centimetres away from navel).
• Izberite območje na zgornjem delu stegen ali na trebuhu (vsaj 5 centimetrov stran od popka).
95 % confidence intervals for the differences in change scores between methotrexate and adalimumab.
95-% intervali zaupanja za razlike v spremembi ocen med metotreksatom in adalimumabom
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli
* further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies
* Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 ** Vključno pri podaljšanih študijah brez placeba
Do not use this medicine after the expiry date which is stated on the label/blister/carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/pretisnem omotu/škatli poleg oznake "EXP".
• Remove needle from skin at the same angle you inserted it (45 degree angle).
• Iglo odstranite iz kože pod enakim kotom, kot ste jo vstavili (45 stopinj).
Scarring may also occur in affected areas.
Na prizadetih področjih se lahko pojavijo tudi
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o
CI 95 % for HR
95-% IZ za RT
It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
Zelo pomembno je, da obvestite zdravnika, če ste kadar koli imeli tuberkulozo ali ste bili v tesnem stiku s kom, ki jo je imel.
• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active HBV infection or if you think you might be at risk of contracting HBV.
• Obvestite zdravnika, če ste nosilec virusa hepatitisa B (HBV), če imate aktivno okužbo s HBV ali če mislite, da bi se lahko nalezli HBV.
• The Summary of Product Characteristics • Guide for healthcare professionals
• povzetek glavnih značilnosti zdravila • vodnik za zdravstvene delavce
Call your healthcare
Pokličite zdravstveno osebje.
If you accidentally inject Cyltezo more frequently than you should, call your doctor or pharmacist and explain that you have taken more.
Če pomotoma injicirate zdravilo Cyltezo pogosteje kot bi morali, se morate posvetovati z zdravnikom ali farmacevtom in mu razložiti, da ste uporabili večji odmerek.
• Certain vaccines contain weakened but live forms of bacteria or viruses that cause diseases, and should not be given while receiving Cyltezo because they may cause infections.
• Določena cepiva vsebujejo oslabljene, a žive oblike bakterij ali virusov, ki povzročijo bolezni, zato se jih med zdravljenjem z zdravilom Cyltezo ne sme uporabljati, ker lahko povzročijo okužbo.
• Select a different site each time you inject at least 2.5 centimetres away from a previous site.
• Vsakič izberite drugo mesto injiciranja vsaj 2,5 centimetra stran od predhodno uporabljenega
Read all of this leaflet carefully before you start using this medicine because it contains important
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne
There is little experience from re-administration after more than 8 weeks since the previous dose.
Izkušenj s ponovno uporabo po več kot 8 tednih od prejšnjega odmerka
• On rare occasions, treatment with Cyltezo could result in lupus-like syndrome.
• V redkih primerih lahko zdravljenje z zdravilom Cyltezo povzroči lupusu podoben sindrom.
The safety and efficacy of adalimumab in children aged 4-17 years have not yet been established.
Varnost in učinkovitost adalimumaba pri otrocih, starih od 4 do 17 let, še nista bili dokazani.
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Ta redka oblika T-celičnega limfoma ima zelo agresiven potek bolezni in je običajno smrtna.
You will inject into this raised area of
Injicirali boste v ta
An asterisk (*) appears in the SOC column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
V stolpcu organski sistem se pojavi znak zvezdica (*), če so v zvezi s tem vključene dodatne informacije v poglavjih 4.3, 4.4 in 4.8.
Side effects may occur up to 4 months or more after the last Cyltezo injection.
Neželeni učinki se lahko pojavijo vsaj še 4 mesece ali več po zadnji injekciji zdravila Cyltezo.
If you forget to give yourself an injection, you should inject the next dose of Cyltezo as soon as you remember.
Če si pozabite dati injekcijo, si morate naslednji odmerek zdravila Cyltezo injicirati, čim se spomnite.
You and your doctor should pay special attention to signs of infection while you are being treated with Cyltezo.
Vi sami in vaš zdravnik morata biti posebej pozorna na znake okužbe, medtem ko ste zdravljeni z zdravilom Cyltezo.
Cyltezo can also be given alone.
Zdravilo Cyltezo se lahko daje tudi samo.
It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).
Pomembno je, da obvestite zdravnika, če ste imeli ali imate kakšno resno bolezen srca (glejte "Opozorila in previdnostni ukrepi").
Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80 % of patients continued to receive at least one of
Dovoljena je bila sočasna uporaba stabilnih odmerkov aminosalicilatov, kortikosteroidov in/ali imunomodulacijskih zdravil; 80 % bolnikov je še naprej prejemalo vsaj eno od takšnih zdravil.
• If you are over 65 years you may be more susceptible to infections while taking Cyltezo.
• Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo Cyltezo.
The patient alert card shall contain the following key messages:
Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila:
• Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of
• Obvestite zdravnika, če ste imeli v preteklosti ponavljajoče se okužbe ali druge bolezni, ki povečujejo tveganje za okužbe.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC - 8ºC).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 °C-8 °C).
No dose recommendations can be made.
Priporočila odmerjanja niso možna.
• In some patients the body may fail to produce enough of the blood cells to fight off infections or help you to stop bleeding.
• Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic za premagovanje okužbe ali zaustavljanje krvavitve.
The predicted exposures indicate that in the absence of methotrexate, a loading dose may lead to an initial increase in systemic
Napovedane izpostavljenosti nakazujejo, da lahko polnilni odmerek v odsotnosti metotreksata povzroči začetno povečanje sistemske izpostavljenosti.
• Gently squeeze skin around cleaned injection site and hold firmly.
• Nežno uščipnite kožo okoli očiščenega mesta injiciranja in močno držite.
In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life
V redkih primerih, zlasti če uporabljate druga zdravila, ki zavirajo imunski sistem, je reaktivacija okužbe s HBV lahko smrtno nevarna.
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for
• Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.