natgillin/translations-raw huggingface dataset:
The most common side effects of Rapilysin which may affect more than 10% of the treated patients: • Bleeding at the injection site, e. g. blood blister (haematoma) • Chest Pain / angina, low blood pressure and heart failure / shortness of breath may reappear • Burning sensation when Rapilysin is injected
Najpogostejši neželeni učinki zdravila Rapilysin, ki se lahko pojavijo pri več kot 10% zdravljenih bolnikov, so: • krvavitev na mestu injiciranja, npr. modrica (hematom), • bolečina v prsnem košu/ angina pektoris, nizek krvni tlak in srčno popuščanje/ zadihanost, ki se lahko pojavijo ponovno, • pekoči občutek pri injiciranju zdravila Rapilysin.
Common side effects occurring in 1 to 10% of the treated patients are:
Pogosti neželeni učinki, ki se pojavijo pri 1 do 10% zdravljenih bolnikov, so: • krvavitev v prebavilih (npr. krvavi ali črni izbljuvki, ali blato), iz dlesni, ali v sečilih ali spolovilih, • nenormalno utripanje srca (aritmije), srčni zastoj, cirkulatorni kolaps ali ponovitev srčne kapi.
Uncommon side effects occurring in 0,1 to 1% of the treated patients are: • Bleeding around the heart, in the abdomen, the brain or the eyes, under the skin, from the nose or as coughed up blood • Damage to the heart or heart valves, or a blood clot in the lung, brain or other part of body may occur • hypersensitivity (e. g. allergic reactions)
Občasni neželeni učinki, ki se pojavijo pri 0, 1 do 1% zdravljenih bolnikov, so: • krvavitev okrog srca, v trebušno votlino, možgane ali oči, pod kožo, iz nosu, izkašljevanje krvi, • okvare srca ali srčnih zaklopk, krvi strdek v pljučih, možganih ali drugih delih telesa, • preobčutljivost (npr. alergijske reakcije).
Other less common side effects occurring in less than 0.01% of the treated patients are: • Events related to the nervous system (e. g. epileptic seizure, convulsion, speech disorder, delirium, agitation, confusion, depression, psychosis) • severe allergic reaction, causing shock or collapse
Drugi manj pogosti neželeni učinki, ki se pojavijo pri manj kot 0, 01% zdravljenih bolnikov, so: • dogodki, povezani z živčevjem (npr. epileptični napad, krči, motnje govora, delirij, agitacija, zmedenost, depresija, psihoza), • resna alergijska reakcija, ki povzroči šok ali kolaps.
HOW TO STORE RAPILYSIN
SHRANJEVANJE ZDRAVILA RAPILYSIN
• Keep out of the reach and sight of children.
• Zdravilo shranjujte nedosegljivo otrokom.
• Do not use Rapilysin after the expiry date stated on the carton and on the label of the vial.
• Zdravila Rapilysin ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki viale.
• Keep the vial in the outer carton in order to protect from light.
• Vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
• After reconstitution (“ when dissolved”), the solution must be used immediately.
• Po rekonstituciji (ko je raztopljena) je treba raztopino takoj uporabiti.
What Rapilysin contains:
Kaj vsebuje zdravilo Rapilysin
- The active substance of Rapilysin is reteplase 10U/ 10ml after reconstitution.
- Zdravilna učinkovina zdravila Rapilysin je reteplaza 10 enot/ 10 ml po rekonstituciji.
- The other ingredients in the vials are:
- Pomožne snovi
What Rapilysin looks like and content of the pack
Izgled zdravila Rapilysin in vsebina pakiranja
Rapilysin is presented as a powder and a solvent for injection (0.56 g powder in a vial and 10 ml solvent in a pre-filled syringe with a reconstitution spike and a needle-pack of 2)
Zdravilo Rapilysin je na voljo kot prašek in vehikel za injiciranje v pakiranju po 2 (viali z 0, 56 g praška, napolnjeni injekcijski brizgi z 10 ml vehikla, rekonstitucijska pripomočka in igli).
Manufacturer
Ime in naslov izdelovalca, odgovornega za sproščanje serije
25 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
25 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
This leaflet was last approved in
Navodilo je bilo odobreno {MM/ LLLL}
It contains the active substance efalizumab (100 mg/ ml).
Vsebuje zdravilno učinkovino efalizumab (100 mg/ ml).
PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘ psoralen ’ before being exposed to ultraviolet light.
PUVA je vrsta zdravljenja, pri katerem prejme bolnik, preden je izpostavljen ultravijolični svetlobi, zdravilo, ki vsebuje spojino psoralen.
It is given as a 12-week course, with a first dose of 0.7 mg per kilogram body weight followed by weekly injections of 1.0 mg/ kg.
Daje se 12 tednov, začetni odmerek je 0, 7 mg na kilogram telesne mase, čemur sledijo tedenske injekcije v odmerku 1, 0 mg/ kg.
Efalizumab has been designed to bind to part of a protein called LFA-1 on the surface of lymphocytes, a type of white blood cell that is involved in the inflammation process.
Efalizumab je zasnovan tako, da se veže na del beljakovine, imenovane LFA- 1, na površini limfocitov, tj. na vrsto belih krvničk, ki sodeluje pri vnetnem procesu.
As LFA-1 is important in helping the lymphocytes to stick to cells in the skin, efalizumab reduces the inflammation in the skin that causes psoriasis.
Ker LFA- 1 pomembno pomaga limfocitom, da se vežejo na celice v koži, efalizumab zmanjšuje vnetje kože, ki povzroča psoriazo.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V študijah so sodelovali bolniki, ki v preteklosti niso jemali drugih zdravil za 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Raptiva has been studied in five main studies involving over 3,000 patients with moderate to severe plaque psoriasis.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged psoriazo, ter bolniki, ki so jemali druga zdravila.
In the fifth study, 526 of the 793 patients were ‘ high need’, since they had failed to respond to or could not take other systemic treatments.
V peti raziskavi je bilo 526 izmed 793 bolnikov takih z „ visoko potrebo “, saj se niso odzvali na ali niso mogli jemati drugih sistemskih zdravil.
The main measure of effectiveness was the proportion of patients who ‘ responded ’ to treatment after 12 weeks, meaning that symptom scores improved by 75% or more.
Glavno merilo učinkovitosti je bil delež bolnikov, ki so se po 12 tednih odzvali na zdravljenje, kar je pomenilo, da so se ocene simptomov izboljšale za 75% ali več.
Looking at the results of the first four studies taken together, 320 (26%) of the 1,213 patients receiving 1.0 mg/ kg Raptiva per week responded to treatment, compared with 25 (4%) of the 715 receiving placebo.
Če pogledamo rezultate prvih štirih študij skupaj, ugotovimo, da se je na zdravljenje odzvalo 320 (26%) izmed 1213 bolnikov, ki so prejemali 1, 0 mg/ kg zdravila Raptiva tedensko, v primerjavi s 25 (4%) izmed 715 bolnikov, ki so prejemali placebo.
In the fifth study, overall, 166 (31%) of the 529 patients receiving Raptiva responded to treatment, compared with 11 (4%) of the 264 receiving placebo.
V peti študiji se je na zdravljenje odzvalo skupaj 166 (31%) izmed 529 bolnikov, ki so prejemali zdravilo Raptiva, v primerjavi z 11 (4%) izmed 264 bolnikov, ki so prejemali placebo.
Looking only at the ‘ high need’ patients in this study, 30% of those receiving Raptiva responded to treatment, compared with 3% of those receiving placebo.
Če upoštevamo le bolnike z „ visoko potrebo “ iz te študije, se je na zdravljenje odzvalo 30% izmed tistih, ki so prejemali zdravilo Raptiva, v primerjavi s 3% bolnikov, ki so prejemali placebo.
The Committee for Medicinal products for Human Use (CHMP) noted that psoriasis was more severe in ‘ high-need’ patients, and that the effectiveness of Raptiva is relevant for these patients.
Odbor za zdravila za uporabo v humani medicini (CHMP) je upošteval, da je bila psoriaza hujša pri bolnikih z „ visoko potrebo “ in da je učinkovitost zdravila Raptiva pomembna za te bolnike.
Therefore, the Committee decided that Raptiva’ s benefits are greater than its risks for the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contra-indication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA.
Odbor je zato odločil, da so koristi zdravila Raptiva pri zdravljenju odraslih bolnikov z zmerno do hudo kronično psoriazo s plaki, ki se ne odzivajo na druga sistemska zdravljenja, vključno s ciklosporinom, metotreksatom in PUVA, oziroma imajo zanje kontraindikacije ali jih ne prenašajo, večje od z njim povezanih tveganj.
Powder: vial (glass); solvent: prefilled syringe (glass)
Prašek: viala (steklo)
1 vial + 1 pre-filled syringe + 2 needles
1 viala +1 napolnjena brizga + 2
Powder: vial (glass); solvent: pre- filled syringe (glass)
Prašek: viala (steklo)
4 vials + 4 pre-filled syringes + 8 needles
4 viale + 4 napolnjene brizge +8
12 vials + 12 pre-filled syringes + 24 needles
12 viale + 12 napolnjene brizge
Raptiva 100 mg/ ml powder and solvent for solution for injection
Raptiva 100 mg/ ml prašek in vehikel za raztopino za injiciranje
Reconstitution with the solvent yields a solution containing efalizumab at 100 mg/ ml.
Po rekonstituciji z vehiklom nastane raztopina, ki vsebuje 100 mg/ ml efalizumaba.
2.5 mg polysorbate 20, 3.55 mg histidine, 5.70 mg histidine hydrochloride monohydrate, 102.7 mg sucrose.
2, 5 mg polisorbata 20, 3, 55 mg histidina, 5, 70 mg histidinijevega klorida monohidrata, 102, 7 mg saharoze.
The pH of the reconstituted solution is 5.9 – 6.5.
pH rekonstituirane raztopine je 5, 9 do 6, 5.
Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (see section 5.1 – Clinical Efficacy).
Zdravljenje odraslih bolnikov z zmerno do hudo kronično psoriazo s plaki, ki se ne odzivajo na, ali imajo kontraindikacije za, ali ne prenašajo drugega sistemskega zdravljenja, vključno s ciklosporinom, metotreksatom in PUVA (glejte poglavje 5. 1 – Klinična učinkovitost).
An initial single dose of 0.7 mg/ kg body weight is given followed by weekly injections of 1.0 mg/ kg body weight (maximum single dose should not exceed a total of 200 mg).
Enkratni začetni odmerek je 0, 7 mg/ kg telesne mase, nato sledi enkrat tedensko dajanje injekcij po 1, 0 mg/ kg telesne mase (maksimalni enkratni odmerek ne sme preseči skupno 200 mg).
dose:
Enkratni začetni odmerek:
0.7 mg/ kg
0, 7 mg/ kg Nadaljevalni odmerki:
For discontinuation guidance see section 4.4.
Za smernice o prekinitvi zdravljenja glejte poglavje 4. 4.
2 Children and adolescents (< 18 years) Raptiva is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
Otroci in adolescenti (< 18 let) Zaradi pomankanja podatkov o varnosti in učinkovitosti uporaba Raptive pri otrocih pod 18 let ni priporočljiva.
Use in the elderly (≥ 65 years) The dosage and administration schedule in the elderly should be the same as for adults (see also section 4.4).
2 Uporaba pri starejših (≥ 65 let) Odmerjanje in shema dajanja pri starejših morata biti enaka kot za odrasle (glejte tudi poglavje 4. 4).
Patients with renal or hepatic impairment No studies have been conducted in patients with renal or hepatic impairment.
Bolniki z ledvično ali jetrno okvaro Študij z bolniki z ledvično ali jetrno okvaro niso izvedli.
Method of administration Raptiva is for subcutaneous injection.
Način uporabe Raptivo se daje v obliki subkutane injekcije.
For instructions for use see section 6.6.
Za navodila za uporabo glejte poglavje 6. 6.
a) Infections Raptiva is a selective immunosuppressor that alters T-lymphocyte function and may affect host defences against infections.
a) Okužbe Raptiva je selektivni zaviralec imunske odzivnosti, ki spremeni delovanje limfocitov T in lahko prizadene obrambo gostitelja proti okužbam.
JC virus infection.
Poveča lahko tveganje za okužbe ali za resnost okužbe, na primer za tuberkulozno pljučnico in reaktivira latentne, kronične okužbe, na primer JC virusne okužbe.
One case of JC virus infection resulting in PML has been reported in post-marketing surveillance in a patient with psoriasis receiving Raptiva (see section 4.8).
V okviru postmarketinških izkušenj so poročali o enem primeru JC virusne okužbe, ki se je kazala kot PML pri bolniku, ki je imel psoriazo in je prejemal zdravilo Raptiva (glejte poglavje 4. 8).
The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
Če je to potrjeno, je treba preveriti, če simptomi morda kažejo na možnost za pojav PML.
b) Vaccinations Limited data are available on the effects of vaccination.
b) Cepljenje Podatki o vplivu na cepljenje so omejeni.
Neo-vaccinations given during treatment with Raptiva may induce antibody levels lower than those observed in non-treated subjects, but the clinical
Bolniki, ki so imeli novo cepljenje med zdravljenjem z Raptivo, so razvili manj protiteles kot tisti, ki niso uporabljali Raptive, vendar kliničen pomen tega pojava ni znan.
3 significance of this is unknown.
3 cepiv.
(see section 4.5).
Zdravljenje z Raptivo je treba prekiniti 8 tednov pred cepljenjem in se ga lahko nadaljuje 2 tedna po cepljenju (glejte poglavje 4. 5).
c) Malignancies and lymphoproliferative disorders It is not yet known whether or not Raptiva can increase the risk of lymphoproliferative disorders or other malignancies in psoriasis patients.
c) Maligne in limfoproliferativne bolezni Ni še znano ali lahko Raptiva poveča ali ne tveganje za limfoproliferativne bolezni ali druge maligne bolezni pri bolnikih s psoriazo.
Raptiva should be discontinued if a malignancy develops while the patient is on treatment (see sections 4.3 and 4.8).
Dajanje Raptive je treba prekiniti, če se med zdravljenjem razvije maligno obolenje (glejte poglavji 4. 3 in 4. 8).
Therefore, combination therapies with these products are not recommended (see section 4.5).
Zato sočasno zdravljenje s temi zdravili ni priporočljivo (glejte poglavje 4. 5).
Immune-mediated haemolytic anaemia In post-marketing surveillance, isolated cases of severe haemolytic anaemia have been reported during treatment with Raptiva.
Imunsko posredovana hemolitična anemija V času spremljanja zdravila na trgu po pridobitvi dovoljenja za promet so poročali o posamičnih primerih hude hemolitične anemije med zdravljenjem z Raptivo.
Thrombocytopenia Thrombocytopenia may occur during Raptiva treatment and may be associated with clinical signs such as echymoses, spontaneous bruising or bleeding from muco-cutaneous tissues.
Trombocitopenija Med zdravljenjem z Raptivo se lahko pojavi trombocitopenija in je lahko povezana s kliničnimi znaki kot so ehimoze, spontane modrice ali krvavitve sluznic in kože.
If these manifestations occur, efalizumab should be stopped immediately, a platelet count should be performed and appropriate symptomatic treatment should be instituted immediately (see section 4.8).
Če se ti znaki pojavijo, moramo takoj prekiniti z uporabo efalizumaba in določiti število trombocitov v krvi ter takoj uvesti ustrezno simptomatsko zdravljenje (glejte poglavje 4. 8).
It is recommended that assessments be more frequent when initiating therapy (e. g., monthly) and may decrease in frequency with continued treatment (e. g., every 3 months).
Pogostejše določanje je priporočljivo na začetku zdravljenja (npr. enkrat mesečno) in je lahko v nadaljevanju zdravljenja manj pogosto (npr. vsake 3 mesece).
Inflammatory polyradiculoneuropathy Cases of inflammatory polyradiculoneuropathy have been observed in post-marketing surveillance in patients receiving Raptiva (see section 4.8).
Vnetna poliradikulonevropatija Pri bolnikih, ki so prejemali Raptivo, so opazili primere vnetne poliradikulonevropatije (glejte poglavje 4. 8).
Hypersensitivity and allergic reactions As with any recombinant product, Raptiva is potentially immunogenic.
Preobčutljivost in alergijske reakcije Kot vsa rekombinantna zdravila je tudi Raptiva potencialno imunogena.
Consequently, if any serious hypersensitivity or allergic reaction occurs, Raptiva should be discontinued immediately and appropriate therapy initiated (see sections 4.3 and 4.8).
Zato se mora v primeru pojava hude preobčutljivostne ali alergijske reakcije takoj prekiniti z uporabo Raptive in uvesti ustrezno zdravljenje (glejte poglavji 4. 3 in 4. 8).
Arthritis Cases of arthritis have been observed during treatment or after discontinuation of Raptiva.
Artritis Opazili so primere artritisa med zdravljenjem ali po prekinitvi zdravljenja z Raptivo.
Psoriasis During treatment with Raptiva, cases of exacerbation of psoriasis, including pustular, erythrodermic, and guttate subtypes, have been observed (see section 4.8).
Psoriaza Med zdravljenjem z Raptivo so opazili primere izbruhov psoriaze, vključno s pustuloznimi, eritrodermičnimi in gutatnimi podtipi (glejte poglavje 4. 8).
Discontinuation Management of patients discontinuing Raptiva includes close observation.
Prekinitev zdravljenja Vodenje bolnikov ob prekinitvi zdravljenja z Raptivo vključuje skrbno spremljanje bolnikov.
4 Special patient populations No differences in safety or efficacy were observed between elderly (≥ 65 years) patients and younger patients.
Posebne skupine bolnikov Med starejšimi (≥ 65 let) bolniki in mlajšimi bolniki niso opazili nobenih razlik v varnosti in
See section 4.8 regarding the effects on the hepatic function.
Ker je pri starejših bolnikih na splošno večja incidenca okužb, je pri zdravljenju starejših potrebna previdnost.
Antibody response to an experimental neo-antigen (∅ X174) was reduced during Raptiva therapy, but began to normalize 6 weeks after discontinuation of Raptiva therapy and did not demonstrate tolerance induction.
Med zdravljenjem z Raptivo se je zmanjšal odziv protiteles na eksperimentalni neo- antigen (∅X174), vendar se je začel normalizirati 6 tednov po prekinitvi zdravljenja z Raptivo brez znakov razvoja tolerance.
(See section 4.4).
Med zdravljenjem z Raptivo bolniki ne smejo prejemati živih ali živih oslabljenih cepiv (Glejte poglavje 4. 4.).
Given the mechanism of action of efalizumab, its effects on the immune system may be potentiated by systemic immunosuppressives commonly used for the treatment of psoriasis (see section 4.4).
Glede na mehanizem delovanja efalizumaba, lahko njegove učinke na imunski sistem potencirajo sistemski imunosupresivi, ki se običajno uporabljajo za zdravljenje psoriaze (glejte poglavje 4. 4).
Pregnancy In general, immunoglobulins are known to cross the placental barrier.
Nosečnost Na splošno je znano, da imunoglobulini prehajajo skozi placento.
Lactation Excretion of efalizumab in human milk has not been investigated, however immunoglobulins are expected to be excreted in human milk.
Dojenje Izločanja efalizumaba v mleko pri človeku niso proučevali, vendar se izločanje imunoglobulinov v mleko pri človeku pričakuje.
Based on the pharmacological mechanism of action of efalizumab, the use of Raptiva is not expected to affect patient’ s ability to drive and use machines.
Na podlagi farmakološkega mehanizma delovanja efalizumaba, ni pričakovati, da bi uporaba Raptive vplivala na bolnikovo sposobnost vožnje in upravljanja s stroji.
The most frequent symptomatic adverse drug reactions (ADRs) observed during Raptiva therapy were mild to moderate dose-related acute flu-like symptoms including headache, fever, chills, nausea and 5 myalgia.
Najbolj pogosti simptomatski neželeni učinki (ADS – » adverse drug reactions «), ki so jih opazili med zdravljenjem z Raptivo so bili blagi do zmerni od odmerka odvisni akutni gripi podobni simptomi, vključno z glavobolom, zvišano telesno temperaturo, mrzlico, slabostjo in bolečinami v mišicah.
In large placebo-controlled clinical studies, these reactions were observed in approximately 41% of Raptiva-treated patients and 24% in placebo-treated patients over 12 weeks of treatment.
V velikih s placebom kontroliranih kliničnih študijah so opazili te reakcije pri približno 41% bolnikov,
Antibodies to efalizumab were detected in only 6% of patients.
Protitelesa na efalizumab so odkrili samo pri 6% bolnikov.
common (> 1/ 10)
Zelo pogosti (≥1/ 10)
(> 1/ 100 < 1/ 10)
Pogosti (≥1/ 100, < 1/ 10)
(> 1/ 1,000, < 1/ 100)
Občasni (≥1/ 1. 000, < 1/ 100)
(> 1/ 10,000, < 1/ 1,000)
Redki (≥1/ 10. 000, < 1/ 1. 000)
(< 1/ 10,000)
Zelo redki (< 1/ 10. 000)
Aseptic meningitis*, Severe infections*, JC virus infection resulting in progressive multifocal leukoencephalopathy*
Ni znano Aseptični meningitis * Hude okužbe * JC virusna okužba, ki se kaže kot progresivna multifokalna levkoencefalopatija * Imunsko posredovana
Leuko- cytosis and lympho- cytosis
Levkocitoza in
Thrombo- cytopenia
Trombocito -
Immune mediated haemolytic anaemia*
limfatičnega sistema Bolezni imunskega sistema
Immune system disorders
limfocitoza
Nervous system disorders Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora
Facial palsy (Bell’ s palsy)
facialis (Bellova paraliza)
Inflammatory polyradiculo- neuropathy* Interstitial pneumonitis*
Bolezni kože in podkožja Bolezni mišično - skeletnega sistema in vezivnega tkiva
Skin and subcutaneous tissue disorders
Psoriaza Artralgija Artritis / psoriazni artritis (poslabšanje / zagon)
Psoriasis
Urtikarija
Urticaria
Multiformni eritem *
Erythema multiforme*
Splošne težave in
Musculoskeletal and connective tissue disorders
Gripi podobni
Arthralgia Arthritis / Psoriatic arthritis (exacerbation/ flare)
na mestu
General disorders and administration site conditions
mestu aplikacije Preiskave
Flu-like symptoms including fever, headaches, chills, nausea and myalgia
vključno z zvišano telesno temperaturo, glavobolom, mrzlico, slabostjo in bolečinami v mišicah
Back pain, Asthenia
Astenija Zvišanje ravni alkalne fosfataze Zvišanje ravni ALT
Injection site reactions
injiciranja
Investigations
* Dogodki opaženi v času spremljanja zdravila na trgu po pridobitvi dovoljenja za promet.
Elevation of alkaline Phosphatase, Elevation of ALT
Varnostni profil ciljne populacije, kot je opredeljena v poglavju 4. 1, je podoben varnostnemu profilu celotne populacije zdravljene tekom kliničnega razvoja Raptive, kot zgoraj prikazano.
6
6 Dodatni podatki
The safety profile in the target population as defined in section 4.1 is similar to the safety profile in the overall population treated during clinical development of Raptiva as presented above.
Dolgotrajna izpostavljenost Analiza dolgotrajne uporabe v kohortni skupini 339 bolnikov z zmerno do hudo psoriazo, ki so prejemali Raptivo v odmerku 1 mg/ kg/ teden, od katerih se je 166 bolnikov zdravilo najmanj 2 leti in do 3 let, ni pokazala nobenih omembe vrednih razlik v pogostnosti neželenih dogodkov v primerjavi z 12 tedensko izpostavljenostjo Raptivi.
Long-term exposure:
Levkocitoza in limfocitoza:
Leucocytosis and lymphocytosis: in large placebo-controlled and in long-term clinical studies, between 40 and 50% of patients developed sustained asymptomatic lymphocytosis during Raptiva therapy.
V velikih s placebom kontroliranih kliničnih študijah in v dolgotrajnih kliničnih študijah, je med 40 in 50% bolnikov razvilo vztrajno asimptomatsko limfocitozo med zdravljenjem z Raptivo.
All values were between 2.5 fold and 3.5 fold the ULN (Upper Limit of Normal).
Vse vrednosti so bile med 2, 5 kratnimi do 3, 5 kratnimi vrednostmi zgornje normalne meje (ULN – » Upper Limit of Normal «).
In the combined safety database of 3291 Raptiva-treated patients at the time of approval, there were nine occurrences (0.3%) of thrombocytopenia with less than 52,000 cells per μ l reported.
V skupni podatkovni bazi 3. 291 bolnikov zdravljenih z Raptivo, v času odobritve zdravila, so poročali o 9 pojavih (0, 3%) trombocitopenije s številom trombocitov manjšim od 52. 000 v μl.
In the same population two cases of severe thrombocytopenia (0.6%) of rapid onset were observed (See section 4.4).
V isti populaciji so opazili dva primera hude nenadne trombocitopenije (0, 6%) (glejte poglavje 4. 4).