natgillin/translations-raw huggingface dataset:
In both studies patients' disease had not responded satisfactorily to other treatment.
V nobeni od obeh študij odziv bolnikov na drugo zdravljenje bolezni ni bil zadovoljiv.
Xeljanz received a marketing authorisation valid throughout the EU on 22 March 2017.
Za zdravilo Xeljanz je bilo 22. marca 2017 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency therefore concluded that Xeljanz's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Xeljanz večje od z njim povezanih tveganj in da se odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Xeljanz?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xeljanz?
Other information about Xeljanz
Druge informacije o zdravilu Xeljanz
In general, the risks with Xeljanz were similar to those of other medicines of its class.
Na splošno so tveganja pri zdravilu Xeljanz podobna kot pri drugih zdravilih tega razreda.
Additionally, more patients treated with Xeljanz were able to reduce their use of corticosteroid medicines.
Poleg tega je lahko več bolnikov, zdravljenih z zdravilom Xeljanz, zmanjšalo uporabo kortikosteroidnih zdravil.
As for all medicines, data on the use of Xeljanz are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Xeljanz stalno spremljajo.
The company that markets Xeljanz will provide educational materials to healthcare professionals and patients to increase awareness of the risks with the medicine, particularly the risk of serious infections, and how to manage them.
Družba, ki trži zdravilo Xeljanz, bo priskrbela dodatno izobraževalno gradivo za zdravstvene delavce in bolnike, s katerim bo povečala ozaveščenost o tveganjih zdravila, zlasti o tveganjih za hude okužbe, in podala navodila o tem, kako obvladovati ta tveganja.
The fact that Xeljanz is taken by mouth may be an advantage compared with existing medicines taken as an injection under the skin.
Dejstvo, da se zdravilo Xeljanz jemlje peroralno, je lahko prednost v primerjavi z obstoječimi zdravili, ki se vbrizgavajo pod kožo.
For more information about using Xeljanz, see the package leaflet or contact your doctor or pharmacist.
Za več informacij o uporabi zdravila Xeljanz glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xeljanz have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Xeljanz upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Xeljanz are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Xeljanz, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
Why is Xeljanz authorised in the EU?
Zakaj je bilo zdravilo Xeljanz odobreno v EU?
Xeljanz must not be used in patients with active tuberculosis, serious infections or any opportunistic infection.
Zdravilo Xeljanz se ne sme uporabljati pri bolnikih z aktivno tuberkulozo, hudimi okužbami ali oportunističnimi okužbami.
Most patients in these studies had tried other treatments before and most took Xeljanz with methotrexate.
Večina bolnikov v teh študijah je predhodno že preskusila druga zdravila in večina je jemala zdravilo Xeljanz v kombinaciji z metotreksatom.
An overview of Xeljanz and why it is authorised in the EU
Pregled zdravila Xeljanz in zakaj je odobreno v EU
What benefits of Xeljanz have been shown in studies?
Kakšne koristi zdravila Xeljanz so se pokazale v študijah?
For the treatment of ulcerative colitis, the recommended dose is 10 mg twice a day for the first 8 weeks and then 5 mg twice a day.
Za zdravljenje ulceroznega kolitisa je priporočeni odmerek za prvih osem tednov 10 mg dvakrat na dan, nato pa 5 mg dvakrat na dan.
What are the risks associated with Xeljanz?
Kakšna tveganja so povezana z zdravilom Xeljanz?
For the treatment of rheumatoid arthritis and psoriatic arthritis, the recommended dose is 5 mg taken twice a day.
Za zdravljenje revmatoidnega artritisa in psoriatičnega artritisa je priporočeni odmerek 5 mg dvakrat na dan.
These enzymes play an important role in the process of inflammation that occur in rheumatoid and psoriatic arthritis, and ulcerative colitis.
Ti encimi imajo pomembno vlogo pri procesu vnetja, do katerega pride pri revmatoidnem in psoriatičnem artritisu ter ulceroznem kolitisu.
The active substance in Xeljanz, tofacitinib, works by blocking the action of enzymes known as Janus kinases.
Učinkovina v zdravilu Xeljanz, tofacitinib, deluje tako, da zavira delovanje encimov, znanih kot Janusove kinaze.
Xeljanz can only be obtained with a prescription, and treatment should be started and supervised by a specialist doctor experienced in treating the relevant condition.
Predpisovanje in izdaja zdravila Xeljanz je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem zadevne bolezni.
What is Xeljanz and what is it used for?
Kaj je zdravilo Xeljanz in za kaj se uporablja?
Xeljanz is used together with methotrexate after treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or has led to troublesome side effects.
Zdravilo Xeljanz se uporablja skupaj z metotreksatom, potem ko zdravljenje z enim ali več zdravili, znanimi kot imunomodulirajoča antirevmatična zdravila (DMARD), ni bilo dovolj učinkovito ali je povzročilo problematične neželene učinke.
The most common side effects with Xeljanz (seen in between 1 and 10 patients in 100) are headache, infection and inflammation of the nose and throat, diarrhoea, nausea (feeling sick), joint pain and hypertension (high blood pressure).
Najpogostejši neželeni učinki zdravila Xeljanz (opaženi pri 1 do 10 od 100 bolnikov) so glavobol, okužba, vnetje nosu in grla, driska, navzea (siljenje na bruhanje), bolečine v sklepih in hipertenzija (zvišan krvni tlak).
The most common serious side effects seen with Xeljanz are serious infections such as pneumonia (infection of the lungs), cellulitis (infection of the deep skin tissue), herpes zoster (shingles), urinary tract infection, diverticulitis (infection affecting the intestines) and appendicitis (infection of the appendix) as well as opportunistic infections that can occur in patients with weakened immune systems.
Najpogostejši resni neželeni učinki zdravila Xeljanz so hude okužbe, kot so pljučnica (okužba pljuč), celulitis (okužba globokega kožnega tkiva), herpes zoster (pasovec), okužba sečil, divertikulitis (okužba, ki prizadene črevesje) in apendicitis (okužba slepiča) ter oportunistične okužbe, ki se lahko pojavijo pri bolnikih z oslabljenim imunskim sistemom.
Several studies have shown that Xeljanz is effective at treating rheumatoid arthritis, psoriatic arthritis and ulcerative colitis in patients who had previously tried other treatments.
Več študij je dokazalo, da je zdravilo Xeljanz učinkovito pri zdravljenju revmatoidnega artritisa, psoriatičnega artritisa in ulceroznega kolitisa pri bolnikih, ki so pred tem preskusili druga zdravljenja.
Treatment may be stopped in patients who develop infection, which is a known side effect of the medicine, or in those with abnormal blood tests.
Pri bolnikih, pri katerih se pojavi okužba, kar je znan neželeni učinek zdravila, ali pri bolnikih z nenormalnimi izvidi krvnih preiskav se zdravljenje lahko prekine.
Similarly, in the second study Xeljanz was more effective than placebo at improving symptoms (50% of Xeljanz-treated patients versus 24% of those given placebo) and ability to perform everyday activities.
Podobno je bilo tudi v drugi študiji zdravilo Xeljanz učinkovitejše od placeba pri izboljšanju simptomov (50 % bolnikov, zdravljenih z zdravilom Xeljanz, v primerjavi s 24 % bolnikov, ki so prejemali placebo) in sposobnosti opravljanja vsakodnevnih dejavnosti.
Xeljanz contains the active substance tofacitinib.
Zdravilo Xeljanz vsebuje učinkovino tofacitinib.
Six studies in over 4,200 patients with rheumatoid arthritis have shown that Xeljanz is effective at reducing joint pain and swelling, improving joint movement and slowing down joint damage.
Šest študij pri več kot 4 200 bolnikih z revmatoidnim artritisom pokazalo, da je zdravilo Xeljanz učinkovito pri zmanjševanju bolečin in otekanja sklepov, izboljšanju gibljivosti sklepov in upočasnitvi poškodb sklepov.
Xeljanz must also not be used in patients with severely reduced liver function or in pregnant and breastfeeding women.
Zdravila Xeljanz prav tako ne smejo uporabljati bolniki z močno okrnjenim delovanjem jeter ali nosečnice in doječe matere.
Xeljanz is a medicine for treating adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints, and psoriatic arthritis (red, scaly patches on the skin with inflammation of the joints).
Xeljanz je zdravilo za zdravljenje odraslih z zmernim do hudim revmatoidnim artritisom, boleznijo, ki povzroča vnetje sklepov, in psoriatičnim artritisom (rdeče luskaste lise na koži z vnetjem sklepov).
By blocking the enzymes' action, tofacitinib helps reduce the inflammation and other symptoms of these diseases.
Tofacitinib z zaviranjem njihovega delovanja zmanjša vnetje in druge simptome teh bolezni.
Xeljanz is also used to treat adults with moderate to severe ulcerative colitis, a disease causing inflammation and ulcers in the lining of the gut, after treatment with other medicines has not worked well, has stopped working or has led to troublesome side effects.
Zdravilo Xeljanz se uporablja tudi za zdravljenje odraslih z zmernim do hudim ulceroznim kolitisom, boleznijo, ki povzroča vnetje in razjede v črevesni sluznici, potem ko zdravljenje z drugimi zdravili ni bilo učinkovito, ni bilo več učinkovito ali je povzročilo problematične neželene učinke.
The dose may also be lowered in some patients with reduced kidney or liver function.
Pri nekaterih bolnikih z okrnjenim delovanjem ledvic ali jeter se odmerek lahko zmanjša.
In the first study symptoms improved substantially in 50 and 52% respectively of patients taking Xeljanz and adalimumab for 3 months, compared with 33% of those receiving placebo; patients given Xeljanz or adalimumab also showed a greater improvement in their ability to perform everyday activities.
V prvi študiji so se simptomi pri 50 % oziroma 52 % bolnikov, ki so tri mesece jemali zdravilo Xeljanz oziroma adalimumab, znatno izboljšali, medtem ko je ta delež pri bolnikih, ki so prejemali placebo, znašal 33 %; pri bolnikih, ki so prejemali zdravilo Xeljanz ali adalimumab, se je tudi bolj izboljšala njihova sposobnost opravljanja vsakodnevnih dejavnosti.
The first study compared Xeljanz with adalimumab (an injected medicine for psoriatic arthritis) and placebo in 422 patients.
V prvi študiji se je pri 422 bolnikih zdravilo Xeljanz primerjalo z adalimumabom (vbrizganim zdravilom za psoriatični artritis) in placebom.
Xeljanz is available as tablet (5 and 10 mg) to be taken by mouth.
Zdravilo Xeljanz je na voljo v obliki 5- in 10-miligramskih tablet, ki se jemljejo peroralno.
In patients with rheumatoid arthritis, Xeljanz can also be taken alone by patients who cannot take or are intolerant to methotrexate.
Bolniki z revmatoidnim artritisom, ki metotreksata ne smejo jemati ali ga ne prenašajo, lahko zdravilo Xeljanz jemljejo tudi kot samostojno zdravilo.
The most important side effect seen with the medicine is infection and there are specific recommendations to help healthcare professionals reduce this risk.
Obstajajo posebna priporočila za zdravstvene delavce, kako zmanjšati to tveganje.
In the first study in 614 patients with ulcerative colitis, 18% of patients treated with Xeljanz 10 mg twice a day had mild or no symptoms after 8 weeks of treatment compared with 8% of patients who received placebo.
V prvi študiji, ki je bila opravljena na 614 bolnikih z ulceroznim kolitisom, je imelo po osmih tednih zdravljenja 18 % bolnikov, ki so dvakrat dnevno prejeli 10 mg zdravila Xeljanz, blage simptome ali pa jih niso imeli v primerjavi z 8 % bolnikov, ki so prejemali placebo.
Similarly, in a second study with 547 patients, after 8 weeks of treatment 17% of patients treated with Xeljanz had mild or no symptoms compared with 4% of placebo-treated patients.
Podobno je v drugi študiji, v kateri je sodelovalo 547 bolnikov, po osmih tednih zdravljenja imelo 17 % bolnikov, zdravljenih z zdravilom Xeljanz, blage simptome ali pa jih niso imeli, v primerjavi s 4 % bolnikov, ki so prejemali placebo.
How does Xeljanz work?
Kako zdravilo Xeljanz deluje?
The second study compared Xeljanz with placebo in 395 patients.
V drugi študiji se je pri 395 bolnikih zdravilo Xeljanz primerjalo s placebom.
How is Xeljanz used?
Kako se zdravilo Xeljanz uporablja?
In one of the studies, where Xeljanz was taken alone, Xeljanz was more effective than methotrexate at slowing down joint damage and reducing symptoms.
V eni od študij, v kateri so bolniki zdravilo Xeljanz jemali kot samostojno zdravilo, je bilo zdravilo Xeljanz pri upočasnitvi poškodb sklepov in zmanjševanju simptomov učinkovitejše od metotreksata.
Xeljanz, in combination with methotrexate, was shown to be effective at improving symptoms of psoriatic arthritis in 3 main studies.
V treh glavnih študijah se je zdravilo Xeljanz v kombinaciji z metotreksatom izkazalo kot učinkovito pri izboljšanju simptomov psoriatičnega artritisa.
Xeljanz was more effective than placebo at reducing the symptoms of ulcerative colitis in three main studies.
V treh glavnih študijah je bilo zdravilo Xeljanz učinkovitejše od placeba pri zmanjšanju simptomov ulceroznega kolitisa.
In a third study with 593 patients, 34% of patients treated with Xeljanz 5 mg twice a day had mild or no symptoms after a year of treatment compared with 11% of patients receiving placebo.
V tretji študiji, v kateri je sodelovalo 593 bolnikov, je imelo po enem letu zdravljenja 34 % bolnikov, ki so dvakrat dnevno prejeli 5 mg zdravila Xeljanz, blage simptome ali pa jih niso imeli, kar je veljalo za
In another study, Xeljanz taken alone was more effective than placebo (a dummy treatment) at reducing symptoms, such as pain and swelling.
V drugi študiji je bilo jemanje zdravila Xeljanz kot samostojnega zdravila pri zmanjševanju simptomov, kot sta bolečina in otekanje, učinkovitejše od placeba (zdravilo brez zdravilne učinkovine).
Date of first authorisation: 11 May 2016
Datum prve odobritve: 11. maj 2016
(initial level)
(začetna raven)
Please contact your doctor immediately:
Prosimo, da nemudoma obvestite zdravnika:
The required dose is determined using the following formulae:
Potrebni odmerek določimo z uporabo naslednje formule:
If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Če se pojavijo taki inhibitorji, se bo stanje pokazalo kot nezadosten klinični odziv.
Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Pomembno je omeniti, da ABR ni primerljiv med različnimi koncetrati faktorjev in med različnimi kliničnimi študijami.
Immune tolerance induction
Indukcija imunske tolerance
Frequency of doses (hours) / Duration of therapy (days)
Pogostnost odmerkov (ure) /trajanje zdravljenja (dnevi)
• if you notice symptoms of allergic reactions (see below)
• če opazite simptome alergijskih reakcij (glejte spodaj),
The amount of IDELVION you need to take and the duration of treatment depend on:
Količina zdravila IDELVION, ki ga morate vzeti in trajanje zdravljenja sta odvisna od:
• Inhibitors: the medicine stops working properly (continuous bleeding).
• Inhibitorji: zdravilo preneha delovati pravilno (vztrajna krvavitev).
Therefore, factor IX should be used during pregnancy and lactation only if clearly indicated.
Zato se lahko faktor IX uporablja med nosečnostjo in dojenjem le, če je jasno indicirano.
Your doctor should inform you of the early signs of hypersensitivity reactions.
Vaš zdravnik vas bo poučil o zgodnjih znakih preobčutljivostnih reakcij.
Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Zato je treba bolnike, pri katerih se pojavi alergijska reakcija, pregledati za prisotnost inhibitorja.
After reconstitution the chemical and physical in-use stability has been demonstrated for 8 hours at 2-25 °C).
Po rekonstituciji so kemijsko in fizikalno obstojnost med uporabo dokazali za 8 ur pri temperaturi 2-25 °C.
- Reconstitution and withdrawal must be carried out under aseptic conditions.
- Rekonstitucijo in izsesanje izvajajte pod aseptičnimi pogoji.
All 85 bleeding episodes were successfully treated with 1 or 2 doses of IDELVION.
Vseh 85 epizod krvavitev je bilo uspešno zdravljenih z 1 ali 2 odmerkoma zdravila IDELVION.
Single dose should be sufficient for majority of bleeds.
Enkratni odmerek bi moral zadoščati za večino krvavitev.
The safety and efficacy in the perioperative setting was evaluated in two pivotal Phase 3 studies (Study 3001 and 3002) and the on-going Phase 3 safety extension study (Study 3003).
Varnost in učinkovitost v perioperativnem okolju so ovrednotili v dveh osrednjih študijah faze III (študiji 3001 in 3002) in v podaljšku študije varnosti faze III, ki še poteka (študija 3003).
Frequencies have been evaluated according to the following convention: 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).
Pogostnost je bila ocenjena z naslednjimi dogovorjenimi izrazi: zelo pogosti (≥1/10), pogosti (≥1/100 do < 1/10), občasni (≥1/1000 do <1/100), redki (≥1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Your doctor will calculate the dose of IDELVION you need.
Zdravnik bo izračunal odmerek zdravila IDELVION, ki ga potrebujete.
• If you suffer from liver or cardiac disease or if you have recently had major surgery, please inform your doctor, as there is an increased risk for blood clotting (coagulation) complications.
• Če imate obolenje jeter ali srca ali ste nedavno imeli večji kirurški poseg, obvestite svojega zdravnika, saj obstaja povečano tveganje za zaplete pri strjevanju krvi.
Currently available information support extension of treatment intervals for some patients though potentially associated with an increased risk for bleeding compared to a once weekly regimen.
Trenutno dostopni podatki podpirajo podaljšanje intervala zdravljenja pri nekaterih bolnikih, čeprav so potencialno povezani s povečanim tveganjem za krvavitve v primerjavi s shemo odmerjanja enkrat na teden.
Without opening the vials, warm the IDELVION powder and the liquid to room or body temperature.
Brez da bi odprli viali, segrejte prašek IDELVION in tekočino na sobno ali telesno temperaturo.
IDELVION can be used for all age groups.
Zdravilo IDELVION se lahko uporablja za vse starostne skupine.
Elimination t1/2 (h)
t1/2 izločanja (h)
Repeat PK assessment for up to 30 weeks demonstrated a stable pharmacokinetic profile and incremental recovery was consistent over time.
Ponovitve ocene farmakokinetike v obdobju do 30 tednov so pokazale stabilen farmakokinetičen profil, postopna povrnitev aktivnosti je bila ves čas konsistentna.
Clinical studies investigating safety and efficacy of longer treatment intervals than once weekly are ongoing.
Klinične študije za preučevanje varnosti in učinkovitosti intervalov odmerjanja, daljših od enega tedna, še potekajo.
General Instructions
Splošna navodila
Of the 106 bleeding episodes, the majority (94; 88.7%) was treated with single injection, 103; 97.2% were treated with 1-2 injections.
Od skupno 106 epizod krvavitev je bila večina (94; 88,7 %) zdravljena z enkratno injekcijo, 103; 97,2 % pa z 1-2 injekcijama.
Albumin is a natural, inert carrier protein in plasma with a half-life of approximately 20 days.
Albumin je naravni, inertni nosilec proteinov v plazmi z razpolovno dobo približno 20 dni.
• IDELVION must not be mixed with other medicines or solvents except those mentioned in section 6.
• Zdravila IDELVION ne smemo mešati z drugimi zdravili ali vehikli, razen s tistimi, ki so navedeni v poglavju 6.
If you have any side effects that might be related to the administration of IDELVION, the injection should be stopped (see also sections 2 and 4).
Če se pojavijo neželeni učinki, ki bi lahko bili povezani z dajanjem zdravila IDELVION, je treba injiciranje ustaviti (glejte tudi poglavji 2 in 4).
From a microbiological point of view, the product should be used immediately.
Z mikrobiološkega vidika je treba zdravilo uporabiti takoj po rekonstituciji.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breastfeeding is not available.
Na podlagi redke pojavnosti hemofilije B pri ženskah, podatki o izkušnjah glede uporabe faktorja IX med nosečnostjo in dojenjem niso na voljo.
The product contains traces of hamster proteins (see also “Do not use IDELVION”).
Zdravilo vsebuje sledi proteinov hrčka (glejte tudi podpoglavje "Ne uporabljajte zdravila IDELVION").
Patients with haemophilia B have a lack of this factor which means that their blood does not clot as quickly as it should so there is an increased tendency to bleed.
Bolniki s hemofilijo B imajo pomanjkanje tega faktorja kar pomeni, da se njihova kri ne strjuje tako hitro kot bi se morala in je zato povečana verjetnost za krvavitve.
Haemostatic efficacy at resolution of a bleed was rated excellent or good in 96% of all treated bleeding episodes.
Hemostatska učinkovitost ob prenehanju krvavitve je bila ocenjena kot odlična ali dobra pri 96 % vseh zdravljenih epizod krvavitev.
• if you notice that the medicine stops working properly
• če opazite, da zdravilo ne deluje več pravilno.
Factor IX is involved in blood clotting.
Faktor IX je vključen v proces strjevanja krvi.
Your treatment should be started and monitored by a doctor who is experienced in the treatment of blood clotting disorders.
Vaše zdravljenje mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem krvnih motenj strjevanja.
Care should be taken that no blood enters the syringe filled with product, as there is a risk that the blood could coagulate in the syringe and fibrin clots could therefore be administered to the patient.
Paziti je treba, da kri ne vstopi v brizgo, napolnjeno z zdravilom, saj obstaja tveganje, da kri v brizgi koagulira in bi fibrinski strdek lahko aplicirali bolniku.
• If you are allergic to the active ingredient (albutrepenonacog alfa) or any of the other ingredients
• če ste alergični na učinkovino (albutrepenonakog alfa) ali katero koli sestavino tega zdravila
• If you are allergic to hamster proteins.
• če ste alergični na proteine hrčka.
After a bleeding episode during prophylaxis, patients should maintain their prophylaxis regimen as closely as possible, with 2 doses of IDELVION being administered at least 24 hours apart but longer as deemed suitable for the patient.
Po epizodah krvavitev med profilakso se morajo bolniki čimbolj držati svoje sheme profilakse z 2 odmerkoma zdravila IDELVION, ki sta dana vsaj 24 ur narazen, vendar dlje kot se smatra primerno za bolnika.
IDELVION (50 (IU/kg)) (N=22)
IDELVION (50 (i.e./kg)) (N=22)
In such cases, it is recommended that a specialised haemophilia centre be contacted.
V takih primerih je priporočljivo, da se obrnete na specializirani center za hemofilijo.
• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
Patients < 12 years of age
Bolniki, stari < 12 let
You may develop an inhibitor (neutralising antibody) to factor IX, in which case factor IX will not work properly any more.
Lahko razvijete inhibitorje (nevtralizirajoča protitelesa) proti faktorju IX in v tem primeru faktor IX ne bo več deloval pravilno.