natgillin/translations-raw huggingface dataset:
Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis Studies I − V. In these trials, 11.9% of patients treated with Trudexa and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
V teh preskušanjih so pozitivne titre protijedrnih protiteles po 24 tednih ugotovili pri 11,9% prejemnikov Trudexe in 8,1% prejemnikov placeba in kontrolne učinkovine, ki so imeli izhodiščno negativne titre teh protiteles.
• 2 pre-filled pen, each with 1 alcohol pad, in a blister.
• 2 napolnjena injekcijska peresnika, vsak z 1 alkoholnim zložencem v pretisnem omotu.
• 4 pre-filled pen, each with 1 alcohol pad, in a blister.
• 4 napolnjeni injekcijski peresniki, vsak z 1 alkoholnim zložencem v pretisnem omotu.
Uncommon tinnitus, ear discomfort (including pain and swelling)
Ušesne bolezni, vključno z motnjami labirinta občasni tinitus, neprijetno občutenje v ušesu (vključno z bolečino in otekanjem)
Trudexa is also available as a vial or pre-filled syringe.
Trudexa je na voljo tudi v vialah in napolnjenih injekcijskih brizgah.
Uncommon neutropaenia (including agranulocytosis), leucopaenia, thrombocytopaenia, anaemia, , lymphadenopathy, leucocytosis
Bolezni krvi in limfatičnega sistema pogosti limfopenija občasni nevtropenija (vključno z agranulocitozo), levkopenija, trombocitopenija, anemija, limfadenopatija, levkocitoza redki pancitopenija, idiopatska trombocitopenična purpura
Treatment with Trudexa must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Pri bolnikih, ki se jim na novo pojavijo simptomi kongestivnega srčnega popuščanja ali se jim takšni simptomi poslabšajo, je treba zdravljenje s Trudexo prekiniti.
Uncommon menstrual cycle and uterine bleeding disorders
Motnje reprodukcije in dojk občasni motnje mesečnega cikla in maternične krvavitve
• 6 pre-filled pen, each with 1 alcohol pad, in a blister.
• 6 napolnjenih injekcijskih peresnikov, vsak z 1 alkoholnim zložencem v pretisnem omotu.
NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection Adalimumab
IME ZDRAVILA Trudexa 40 mg raztopina za injiciranje
GAIN: Infliximab Experienced Patients
GAIN: Bolniki, ki so že dobivali infliksimab placebo n = 74
PHARMACEUTICAL FORM Solution for injection in pre-filled pen.
FARMACEVTSKA OBLIKA Raztopina za injiciranje v napolnjenem injekcijskem peresniku.
• ear discomfort;
• neprijeten občutek v ušesu;
Adverse events of the haematologic system, including medically significant cytopoenia (e.g. thrombocytopaenia, leucopaenia) have been infrequently reported with Trudexa.
Med uporabo Trudexe so redko poročali o neželenih učinkih na hematološki sistem, vključno z medicinsko pomembno citopenijo (npr. trombocitopenijo, levkopenijo).
• glaucoma;
• glavkom;
Very Common injection site reaction (including pain, swelling, redness or pruritus)
Splošne težave in spremembe na mestu aplikacije zelo pogosti Reakcija na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo ali srbenjem)
• nausea, diarrhoea, abdominal pain, mouth ulcers;
• slabost v želodcu, driska, bolečine v trebuhu, razjede v ustih;
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena 0,8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba.
Common musculoskeletal pain
Proteinurija, ledvične bolečine
• thyroid disorders;
• bolezni ščitnice;
Uncommon rectal haemorrhage, gastritis, vomiting, dyspepsia, abdominal bloating, constipation,
Bolezni prebavil pogosti diareja, bolečine v trebuhu, stomatitis in razjede v ustih, navzeja občasni rektalna krvavitev, gastritis, bruhanje, dispepsija, napenjanje v trebuhu, zaprtje intestinalna stenoza, kolitis, entreitis, ezofagitis
NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled syringe with needleguard Adalimumab
Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom za iglo adalimumab
STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 ml vial contains 40 mg adalimumab
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 0,8 ml viala vsebuje 40 mg adalimumaba.
NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled syringe with needleguard
IME ZDRAVILA Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom za iglo
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/010
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/010
PHARMACEUTICAL FORM AND CONTENTS 1 pre-filled syringe containing 40 mg adalimumab 1 alcohol pad
FARMACEVTSKA OBLIKA IN VSEBINA 1 napolnjena injekcijska brizga s 40 mg adalimumaba 1 alkoholni zloženec
Trudexa 40 mg solution for injection in vials is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Trudexa 40 mg raztopina za injiciranje v vialah je na voljo kot sterilna raztopina 40 mg adalimumaba, raztopljenega v 0,8 ml raztopine.
STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 ml pre-filled syringe with needleguard contains 40 mg adalimumab
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 0,8 ml napolnjena injekcijska brizga s ščitnikom za iglo vsebuje 40 mg adalimumaba.
PHARMACEUTICAL FORM AND CONTENTS 1 pre-filled pen, containing 40 mg adalimumab 1 alcohol pad
FARMACEVTSKA OBLIKA IN VSEBINA 1 napolnjen injekcijski peresnik s 40 mg adalimumaba 1 alkoholni zloženec
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/008
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/008
Each prefilled pen comes with 1 alcohol pad.
Vsakemu napolnjenemu injekcijskemu peresniku je priložena 1 alkoholna blazinica.
BATCH NUMBER
Pb vrednost
N=170
26. teden n = 170
Mean steady-state trough levels of approximately 7 µg/ml were observed in Crohn's disease patients who received a maintenance dose of 40 mg Trudexa every other week.
Pri bolnikih s Crohnovo boleznijo, ki so dobivali vzdrževalni odmerek 40 mg Trudexe vsak drugi teden, so ugotovili najnižjo koncentracijo v stanju dinamičnega ravnovesja približno 7 µg/ml.
Trudexa 40 mg solution for injection in pre-filled syringe with needleguard is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom za iglo je na voljo kot sterilna raztopina 40 mg adalimumaba, raztopljenega v 0,8 ml raztopine.
Uncommon haematuria, renal impairment, bladder and urethral symptoms,
Bolezni sečil občasni hematurija, okvara ledvične funkcije, simptomi sečnega mehurja in sečnice redki
NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled syringe
IME ZDRAVILA Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
PHARMACEUTICAL FORM AND CONTENTS 6 pre-filled syringes, each containing 40 mg adalimumab 6 alcohol pads
FARMACEVTSKA OBLIKA IN VSEBINA 6 napolnjenih injekcijskih brizg s po 40 mg adalimumaba 6 alkoholnih zložencev
HOW TO STORE TRUDEXA
SHRANJEVANJE ZDRAVILA TRUDEXA
PHARMACEUTICAL FORM AND CONTENTS 4 pre-filled pens, each containing 40 mg adalimumab 4 alcohol pads
FARMACEVTSKA OBLIKA IN VSEBINA 4 napolnjeni injekcijski peresniki s po 40 mg adalimumaba 4 alkoholni zloženci
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/006
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/006
PHARMACEUTICAL FORM AND CONTENTS 2 pre-filled pens, each containing 40 mg adalimumab 2 alcohol pads
FARMACEVTSKA OBLIKA IN VSEBINA 2 napolnjeni injekcijski brizgi s po 40 mg adalimumaba 2 alkoholna zloženca
Rare reports of pancytopenia including aplastic anaemia have been reported with TNF blocking agents.
Pri uporabi zaviralcev TNF je bila v redkih primerih opisana pancitopenija, vključno z aplastično anemijo.
There have been reports of tuberculosis in patients receiving Trudexa.
Pri bolnikih, zdravljenih s Trudexo, so bili opisani primeri tuberkuloze.
Musculoskeletal, connective tissue and bone disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti mišičnoskeletne bolečine redki rabdomioliza
NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled pen
IME ZDRAVILA Trudexa 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/001
Trudexa 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Trudexa 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku je na voljo kot sterilna raztopina 40 mg adalimumaba, raztopljenega v 0,8 ml raztopine.
Week 24 ASAS 70 Week 2
2. teden 12. teden 24. teden ASAS 50 2. teden 12. teden 24. teden ASAS 70 2. teden 12. teden 24. teden
Common lymphopaenia
OZNAČITEV NA BRIZGI
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/009
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/009
• skin wart;
• bradavica na koži;
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/005
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/005
In CLASSIC I and GAIN, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to
Študiji CLASSIC I in GAIN sta pokazali statistično značilno izboljšanje celotnega seštevka po vprašalniku IBDQ (vprašalnik, specifičen za vnetno bolezen črevesa) do 4. tedna pri bolnikih, randomiziranih na shemi s Trudexo 80/40 mg in 160/80 mg, v primerjavi s placebom; razliko 26. in
NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled syringe Adalimumab
Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/004
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/004
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/002
NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled pen Adalimumab
Trudexa 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
PACKAGE LEAFLET: INFORMATION FOR THE USER Trudexa 40 mg solution for injection in pre-filled syringe with needleguard
NAVODILO ZA UPORABO Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom za iglo
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/007
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/007
The treatment should be repeated every two to six weeks.
Zdravljenje je treba ponoviti na dva do šest tednov.
The European Commission granted a marketing authorisation valid throughout the European Union for Evoltra on 29 May 2006.
Evropska komisija je dovoljenje za promet z zdravilom Evoltra, veljavno po vsej Evropski uniji, izdala 29. maja 2006.
The average age of the treated patients was 12 years.
Povprečna starost zdravljenih bolnikov je bila 12 let.
What measures are being taken to ensure the safe and effective use of Evoltra?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Evoltra?
It is given by infusion lasting two hours every day for five days.
Daje se pet dni zapored z infundiranjem, ki vsak dan traja dve uri.
This means that, because the disease is rare, it has not been possible to obtain complete information about Evoltra.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o zdravilu.
Other information about Evoltra
Druge informacije o zdravilu Evoltra
All of the patients had previously received at least two other types of treatment but were not eligible for any other treatment.
Vsi bolniki so pred tem prejeli vsaj dve drugi vrsti zdravljenja, vendar niso bili primerni za nobeno drugo zdravljenje.
In the main study, 20% of the patients went into remission (12 out of 61).
V glavni študiji je do remisije prišlo pri 20 % (12 od 61) bolnikov.
The recommended dose is 52 mg per square metre of body surface area (calculated using the patient's height and weight).
Priporočeni odmerek je 52 mg na kvadratni meter telesne površine (izračunane glede na telesno višino in maso bolnika).
Stem cells are cells that can develop into different types of cell.
Zarodne celice imajo sposobnost, da se lahko razvijejo v različne vrste celic.
A risk management plan has been developed to ensure that Evoltra is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Evoltra je bil pripravljen načrt obvladovanja tveganj.
The study did not compare Evoltra with any other treatments.
V tej študiji zdravila Evoltra niso primerjali z nobenimi drugimi zdravljenji.
The most common side effects with Evoltra (seen in more than 1 patient in 10) were febrile neutropenia (low white blood cell counts with fever), anxiety, headache, flushing (reddening of the face), vomiting, diarrhoea, nausea (feeling sick), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), pruritus (itching), pyrexia (fever), mucosal inflammation (inflammation of the moist body surfaces, such as the lining of the mouth) and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Evoltra (opaženi pri več kot 1 bolniku od 10) so febrilna nevtropenija (nizko število belih krvničk s spremljajočo zvišano telesno temperaturo), tesnoba, glavobol, zardevanje (pordelost obraza), bruhanje, driska, navzeja (slabost), sindrom palmarno-plantarne eritrodisestezije (izpuščaji in odrevenelost v dlaneh in stopalih), pruritus (srbenje), pireksija (zvišana telesna temperatura), mukozno vnetje (vnetje sluznice, kot je ustna sluznica) in utrujenost.
This is a summary of the European public assessment report (EPAR) for Evoltra.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Evoltra.
For more information about treatment with Evoltra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Evoltra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Evoltra has been authorised under ‘exceptional circumstances'.
Zdravilo Evoltra je pridobilo dovoljenje za promet v „izjemnih okoliščinah”.
Most patients who respond to treatment do so after one or two treatment cycles.
Pri večini bolnikov, ki se odzovejo na zdravljenje, do odziva pride po enem ali dveh ciklih zdravljenja.
The summary of opinion of the Committee for Orphan Medicinal Products for Evoltra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare Disease Designations.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Evoltra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
What benefit has Evoltra shown during the studies?
Kakšne koristi je zdravilo Evoltra izkazalo med študijami?
Overall, the patients in the study survived for an average of 66 weeks.
Povprečen čas preživetja bolnikov v študiji je bil 66 tednov.
The company that makes Evoltra will set up a registry to monitor the medicine's side effects.
Družba, ki izdeluje zdravilo Evoltra, bo vzpostavila register za spremljanje neželenih učinkov tega zdravila.
Because the number of patients with ALL is low, the disease is considered ‘rare', and Evoltra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 5 February 2002.
Ker je bolnikov z akutno limfoblastno levkemijo malo, velja ta bolezen za redko, zato je bilo zdravilo Evoltra 5. februarja 2002 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Evoltra, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What is the risk associated with Evoltra?
Kakšna tveganja so povezana z zdravilom Evoltra?
This stops the cells making new DNA and RNA, and slows down the growth of tumour cells.
Zato celice prenehajo izdelovati novo DNK in RNK, rast tumorskih celic pa se upočasni.
The Committee decided that Evoltra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Evoltra večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Clofarabine is an ‘analogue' of adenine, which is part of the fundamental genetic material of cells (DNA and RNA).
Klofarabin je analog adenina, ki je del osnovnega genetskega materiala celic (DNK in RNK).
After treatment with Evoltra, 10 patients were able to go on to have a stem cell transplant.
Po zdravljenju z zdravilom Evoltra je bilo 10 bolnikov sposobnih za presaditev zarodnih celic.
This is a complex procedure where the patient receives stem cells from a matched donor to help restore the bone marrow.
Presaditev je zapleten postopek, v katerem bolnik od ustreznega darovalca prejme zarodne celice, s pomočjo česar se obnovi njegov kostni mozeg.
What information is still awaited for Evoltra?
Katere informacije o zdravilu Evoltra še pričakujemo?
It is used when the disease has not responded to or has come back (relapsed) after at least two other treatments, and when no other treatment is expected to work.
Uporablja se, kadar se bolezen ne odzove na zdravljenje ali se ponovi po vsaj dveh drugih zdravljenjih in kadar se ne pričakuje učinkovitost nobene druge oblike zdravljenja.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Evoltra.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Evoltra is used to treat children and adults up to 21 years of age who have acute lymphoblastic leukaemia (ALL), which is a cancer of the lymphocytes (a type of white blood cell).
Zdravilo Evoltra se uporablja za zdravljenje otrok in odraslih, starih do 21 let, ki imajo akutno limfoblastno levkemijo (ALL), tj. raka limfocitov (vrste belih krvnih celic).
The full EPAR for Evoltra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Evoltra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Evoltra treatment should be started and supervised by a doctor who has experience in the management of patients with acute leukaemias.
Zdravljenje z zdravilom Evoltra lahko začne in nadzoruje le zdravnik, ki ima izkušnje z zdravljenjem bolnikov z akutno levkemijo.
Breast-feeding should be stopped before, during and after treatment with Evoltra.
Pred zdravljenjem z zdravilom Evoltra ter med njim in po njem je treba prenehati z dojenjem.
Evoltra must not be given to patients with severe kidney or liver disease.
Zdravilo Evoltra se ne sme uporabljati pri bolnikih s hudimi obolenji ledvic ali jeter.
For the full list of all side effects reported with Evoltra, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Evoltra, glejte navodilo za uporabo.
Why has Evoltra been approved?
Zakaj je bilo zdravilo Evoltra odobreno?
Patients with ALL who have not responded to or who have relapsed after receiving at least two treatments have a very poor chance of survival.
Bolniki z akutno limfoblastno levkemijo, ki se niso odzvali na zdravljenje ali pri katerih se je bolezen ponovila po vsaj dveh zdravljenjih, imajo zelo malo možnosti za preživetje.
Evoltra is a cancer medicine that contains the active substance clofarabine.
Evoltra je zdravilo proti raku, ki vsebuje zdravilno učinkovino klofarabin.
Evoltra has been examined in one study of 61 patients below 21 years of age with ALL.
Zdravilo Evoltra so proučevali v eni študiji, ki je zajela 61 bolnikov z akutno limfoblastno levkemijo, mlajših od 21 let.
The active substance in Evoltra, clofarabine, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells).
Zdravilna učinkovina zdravila Evoltra, klofarabin, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot so npr. rakaste celice).
This means that clofarabine takes the place of adenine in the body, and interferes with the enzymes involved in making genetic material, called ‘DNA polymerase' and ‘RNA reductase'.
To pomeni, da v telesu prevzame mesto adenina in ovira encima DNK polimerazo in RNK reduktazo, ki sodelujeta pri izgradnji genetskega materiala.
The CHMP concluded that Evoltra treatment may provide a way of obtaining remission, and of facilitating a stem cell transplant.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je z zdravilom Evoltra možno doseči remisijo in olajšati presaditev zarodnih celic.
How has Evoltra been studied?
Kako je bilo zdravilo Evoltra raziskano?
What is Evoltra used for?
Za kaj se zdravilo Evoltra uporablja?
How is Evoltra used?
Kako se zdravilo Evoltra uporablja?
How does Evoltra work?
Kako zdravilo Evoltra deluje?
MA EU Number (Invented) name
Številka EU Izmišljeno ime
30 sachets + 2 syringes + 1 mixing cup
30 vrečk + 2 brizgi + 1 mešalna skodelica
Strength Pharmaceutical Form
Jakost Farmacevtska oblika Pot uporabe Ovojnina
90 (3 x 30) tablets
90 (3 x 30) tablet prašek za peroralno suspenzijo vrečka (PE/alu/PET)
1 vial
Velikost pakiranja viala (steklena) 1 viala
Immediate Packaging
Jakost Farmacevtska oblika
Pack size
Pot uporabe Stična ovojnina
See sections 5.1 and 5.2.
Glejte poglavji 5.1 in 5.2.
Do not use external heat.
Ne uporabljajte zunanjih virov toplote.
This would be checked by your doctor.
To mora preveriti zdravnik.
Wash your hands before opening the pack.
Preden odprete pakiranje, si umijte roke.
Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Izpostaviti velja, da ABR ni primerljiv med različnimi koncentrati faktorjev in med različnimi kliničnimi študijami.
This is of importance particularly when changing the laboratory and/or reagents used in the assay.
To je pomembno zlasti pri menjavi laboratorija in/ali reagenta, uporabljenega za preiskavo.
Patients were less than 12 years of age (15 were <6 years of age and 15 were 6 to <12 years of age).
Bolniki so bili stari manj kot 12 let (15 jih je bilo starih < 6 let, 15 pa od 6 do < 12 let).
Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Zato se lahko faktor IX uporablja med nosečnostjo in dojenjem le, če je jasno indiciran.
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).
Pogostnosti so bile ocenjene v skladu z naslednjim dogovorom: 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 (ni mogoče oceniti iz razpoložljivih podatkov).
How often you need an injection will depend on how well ALPROLIX is working for you.
Kako pogosto boste potrebovali injekcijo bo odvisno od tega, kako dobro zdravilo ALPROLIX deluje pri vas.
Post Marketing Experience
Postmarketinške izkušnje
For extent and age characterisation of the safety database in children see section 5.1.
Za obseg in karakterizacijo starosti v zbirki podatkov o varnosti pri otrocih glejte poglavje 5.1
1 See section 4.2; NA: Not available
1 Glejte poglavje 4.2; n/v: ni na voljo.
Administration (Intravenous Injection):
Dajanje (intravensko injiciranje):
(pre- and post-operative)
(pred operacijo in po njej)
• if you are allergic to eftrenonacog alfa or any other ingredients of this medicine (listed in section 6).
• če ste alergični na eftrenonakog alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6).