natgillin/translations-raw huggingface dataset:
In the first 12 weeks of placebo-controlled studies, the rate of psoriasis adverse events was 3.2% in the Raptiva-treated patients and 1.4% in the placebo-treated patients.
V prvih 12 tednih s placebom kontroliranih kliničnih študij, je bil delež neželenih dogodkov psoriaze 3, 2% v skupini bolnikov, ki so prejemali Raptivo in 1, 4% v skupini bolnikov, ki so prejemali placebo.
Among 3291 patients in the combined safety database, 39 patients presented an erythrodermic or pustular psoriasis (1.2%).
Med 3. 291 bolniki v skupni podatkovni bazi, je 39 bolnikov razvilo eritrodermično ali pustulozno psoriazo (1, 2%).
In the cases occurring during treatment, most of these events (16/ 22) occurred in patients presenting no response to Raptiva.
V primerih pojava med zdravljenjem, je večina teh dogodkov (16/ 22) nastopila pri bolnikih, ki niso pokazali odziva na zdravljenje z Raptivo.
Arthritis / Psoriatic arthritis:
Artritis/ psoriazni artritis:
In the first 12 weeks of placebo-controlled studies, arthritis and exacerbation or flare of arthritis were observed in 1.8% of Raptiva-treated patients and placebo-treated patients.
V prvih 12 tednih s placebom kontroliranih kliničnih študij, so opazili artritis in poslabšanje ali ponovni zagon artritisa pri 1, 8% bolnikov, ki so se zdravili z Raptivo ali so prejemali placebo.
In large placebo-controlled clinical studies, approximately 20% of patients in excess of placebo reported flu-like symptoms including headaches, chills, fever, nausea and myalgia.
V velikih s placebom kontroliranih kliničnih študijah je približno 20% bolnikov več kot pri placebu poročalo o gripi podobnih simptomih, vključno z glavobolom, mrzlico, zvišano telesno temperaturo, slabostjo in bolečinami v mišicah.
The percentage of patients reporting flu-like symptoms was greatest with the first injection and decreased by more than 50% with the second injection.
Delež bolnikov, ki so poročali o gripi podobnih simptomih, je bil največji po prvi injekciji in se je zmanjšal za več kot 50% po drugi injekciji.
None of those events was serious and less than 5% were considered severe.
Nobeden od teh dogodkov ni bil resen in manj kot 5% so ocenili kot hude.
Overall less than 1% of patients discontinued therapy because of acute flu-like symptoms.
Skupno je manj kot 1% bolnikov prekinil zdravljenje zaradi gripi podobnih simptomov.
In large placebo-controlled clinical studies, the percentage of patients experiencing an adverse event suggestive of hypersensitivity, including urticaria, rash and allergic reactions was slightly higher in the Raptiva group (8%) than in the placebo group (7%).
V velikih s placebom kontroliranih kliničnih študijah, je bil delež bolnikov, ki so doživeli neželene dogodke, ki bi lahko kazali na preobčutljivost, vključno z urtikarijo, izpuščajem in alergijskimi reakcijam, rahlo večji v skupini bolnikov, ki so prejemali Raptivo (8%) kot v skupini bolnikov, ki so prejemali placebo (7%).
(See section 4.4).
(Glejte poglavje 4. 4).
7 Elevation of alkaline phosphatase:
7 Dvig ravni alkaline fosfataze:
In large placebo-controlled clinical studies approximately 4.5% of patients developed sustained elevation of alkaline phosphatase throughout Raptiva therapy compared to 1% in placebo patients.
V velikih s placebom kontroliranih kliničnih študijah je približno 4, 5% bolnikov razvilo vztrajno povečano raven alkalne fosfataze tekom celotnega zdravljenja z Raptivo v primerjavi z 1% bolnikov, ki so prejemali placebo.
All values were between 1.5 fold and 3 fold the ULN, and returned to baseline levels after therapy discontinuation.
Vse vrednosti so bile med 1, 5 kratno in 3 kratno vrednostjo ULN in so se povrnile na izhodiščno vrednost po prekinitvi zdravljenja.
About 5.7% of patients developed elevation in ALT during Raptiva therapy compared to 3.5% in placebo.
Približno 5, 7% bolnikov se je zvišala raven ALT med zdravljenjem z Raptivo v primerjavi s 3, 5% bolnikov, ki so prejemali placebo.
All occurrences were asymptomatic and values above 2.5 fold ULN were not more frequent in the Raptiva group than in the placebo group.
Vsi pojavi so bili asimptomatski in vrednosti nad 2, 5 kratno ULN niso bile bolj pogoste v skupini bolnikov z Raptivo kot v skupini bolnikov s placebom.
In placebo controlled clinical trials, infection rates in Raptiva-treated patients was approximately 27.3% versus 24.0% in placebo-treated patients.
V s placebom kontroliranih kliničnih preskušanjih je bil delež okužb bolnikov, ki so prejemali Raptivo približno 27, 3%, v primerjavi z 24, 0% pri bolnikih, ki so prejemali placebo.
In the target population studied in study IMP24011, the infection rate in Raptiva-treated patients was approximately 25.7% versus 22.3% in placebo-treated patients.
V ciljni populaciji, ki so jo proučevali v študiji IMP24011, je bil delež okužb pri bolnikih, ki so prejemali Raptivo približno 25, 7%, v primerjavi z 22, 3% pri bolnikih, ki so prejemali placebo.
As regards serious infections, the overall incidence in both controlled and uncontrolled studies of up to 12 weeks was 2.8 per 100 patient-years for Raptiva-treated patients compared with 1.4 per 100 patient-years for placebo-treated patients.
Kar zadeva resne okužbe, je bila celokupna incidenca, tako v kontroliranih kot v nekontroliranih študijah do 12 tednov, 2, 8 na 100 bolnikov- let za skupino bolnikov, ki so prejemali Raptivo v primerjavi z 1, 4 na 100 bolnikov- let za skupino bolnikov, ki so prejemali placebo.
Over long term treatment, the incidence of serious infection was 1.8 per 100 patient years (see section 4.).
(Glejte poglavje 4).
JC virus infection resulting in PML has been reported in post-marketing surveillance in a patient with psoriasis receiving Raptiva (see section 4.4).
Pri bolniku s psoriazo, ki je prejemal zdravilo Raptiva, so v okviru postmarketinških izkušenj poročali o pojavu JC virusne okužbe, ki se je kazala v obliki PML (glejte poglavje 4. 4).
0.9 per 100 patient-years, short term and long term treatment, respectively) (See section 4.4).
Ni bilo dokazov, da se sčasoma poveča tveganje za katerokoli določeno vrsto malignosti, z izjemo nemelanomskega kožnega raka (0, 3 proti 0, 9 na 100 bolnikov- let, pri kratkotrajnem oziroma dolgotrajnem zdravljenju) (glejte poglavje 4. 4).
In a clinical study, where subjects were exposed to higher doses of efalizumab (up to 10 mg/ kg intravenous), one subject receiving 3 mg/ kg intravenous dose experienced hypertension, chills, and fever on the day of study drug dosing, which required hospitalization.
V klinični študiji, kjer so bili posamezniki izpostavljeni višjim odmerkom efalizumaba (do 10 mg/ kg intravensko), je ena oseba, ki je prejela 3 mg/ kg intravensko, doživela hipertenzijo, mrazenje in vročino na dan odmerjanja preizkušanega zdravila, kar je zahtevalo hospitalizacijo.
Another subject who received 10 mg/ kg intravenous dose experienced severe vomiting following administration of efalizumab, which also required hospitalization.
Druga oseba, ki je prejela odmerek 10 mg/ kg intravensko, je doživela hudo bruhanje po aplikaciji efalizumaba, kar je prav tako zahtevalo hospitalizacijo.
Doses up to 4 mg/ kg/ week subcutaneously for 10 weeks have been administered without any toxic effect.
Odmerke do 4 mg/ kg/ teden subkutano, 10 tednov, so uporabljali brez vsakih toksičnih učinkov.
Pharmacotherapeutic group: selective immunosuppressive agents, ATC code:
Farmakoterapevtska skupina: zdravila za selektivno zaviranje imunske odzivnosti, Oznaka ATC:
Mechanism of action Efalizumab is a recombinant humanized monoclonal antibody that binds specifically to the CD11a subunit of LFA-1 (lymphocyte function-associated antigen-1), a leukocyte cell surface protein.
Mehanizem delovanja Efalizumab je rekombinantno humanizirano monoklonalno protitelo, ki se specifično veže za CD11a podenoto LFA- 1 (limfocitni funkcijski antigen- 1), protein na površini celice levkocita.
By this mechanism, efalizumab inhibits the binding of LFA-1 to ICAM-1, which interferes with T lymphocytes adhesion to other cell types.
S tem mehanizmom efalizumab inhibira vezavo LFA- 1 na ICAM- 1 (medcelična adhezijska molekula - 1), kar moti adhezijo limfocitov T na druge tipe celic.
LFA-1 is present on activated T lymphocytes, and ICAM-1 is up-regulated on endothelial cells and keratinocytes in psoriasis plaques.
LFA- 1 je prisoten na aktiviranih limfocitih T in ICAM- 1 je pozitivno reguliran na endotelijskih celicah in keratinocitih in psoriaznem plaku.
By preventing LFA-1/ ICAM binding, efalizumab may alleviate signs and symptoms of psoriasis by inhibiting several stages in the immunologic cascade.
S preprečevanjem vezave LFA- 1/ ICAM, lahko efalizumab ublaži znake in simptome psoriaze z inhibicijo več stopenj imunološke kaskade.
Pharmacodynamic effects In studies using an initial dose of 0.7 mg/ kg followed by 11 weekly doses of 1.0 mg/ kg, efalizumab maximally reduced expression of CD11a on circulating T lymphocytes to approximately 15-30% of pre-dose baseline values and saturated CD11a to < 5% of baseline available CD11a binding sites.
Farmakodinamični učinki V študijah z začetnim odmerkom 0, 7 mg/ kg, ki mu sledi 11 tedenskih odmerkov 1, 0 mg/ kg, je efalizumab maksimalno zmanjšal ekspresijo CD11a na cirkulirajočih limfocitih T na približno 15- 30% izhodiščne vrednosti pred odmerkom in saturiranega CD11a na < 5% v izhodišču razpoložljivih CD11a vezavnih mest.
Within 5 to 8 weeks following the 12th and final dose of efalizumab administered at 1.0 mg/ kg/ wk, CD11a levels returned to within a range of ±25% of baseline values.
V 5 do 8 tednih po dvanajstem in zadnjem odmerku efalizumaba 1, 0 mg/ kg/ teden, so se CD11a ravni povrnile na ±25% izhodiščnih vrednosti.
In clinical trials, mean lymphocyte counts approximately doubled relative to baseline in subjects receiving 1.0 mg/ kg/ wk of Raptiva.
V kliničnih preskušanjih se je povprečno število limfocitov približno podvojilo glede na izhodiščno vrednost pri bolnikih, ki so prejemali 1, 0 mg/ kg/ teden Raptive.
At a dose of 1.0 mg/ kg/ wk subcutaneous efalizumab, lymphocyte levels returned to within 10% of baseline by 8 weeks post last dose.
Pri odmerku efalizumaba 1, 0 mg/ kg/ teden subkutano, se je raven limfocitov povrnila na 10% izhodiščne vrednosti v 8 tednih po zadnjem odmerku.
Clinical efficacy The efficacy of Raptiva versus other systemic therapies in patients with moderate to severe psoriasis has not been evaluated in studies directly comparing Raptiva with other systemic therapies.
Klinična učinkovitost Učinkovitost Raptive v primerjavi z drugimi sistemskimi zdravili, pri bolnikih z zmerno do hudo psoriazo, ni bila ovrednotena v študijah z direktno primerjavo Raptive z drugimi sistemskimi zdravili.
The present results of Raptiva versus placebo over 12 weeks of treatment with different populations indicate a PASI 75 response to Raptiva in 22% to 39% of patients (see Table 2).
Dosedanji rezultati zdravljenja z Raptivo v primerjavi s placebom v 12 tedenskem zdravljenju različnih populacij, kažejo na PASI 75 odziv na Raptivo, pri 22% do 39% bolnikov (glejte tabelo 2).
Based on the clinical development data generated (see Table 1) and long-term experience, Raptiva is recommended for use in patients as defined in section 4.1.
Na podlagi pridobljenih podatkov v kliničnem razvoju (glejte tabelo 1) in dolgotrajnih izkušenj, je Raptiva priporočena za uporabo pri bolnikih kot je definirano v poglavju 4. 1.
Failure on prior systemic therapies is defined as insufficient response (PASI < 50 or PGA less than good), or worsening of disease in patients while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the 3 major systemic therapies as available.
Neuspeh predhodnih sistemskih terapij je opredeljen kot nezadosten odziv (PASI < 50 ali PGA manj kot dobro), ali poslabšanje bolezni med zdravljenjem pri bolnikih, ki so prejemali zadostne odmerke v zadosti dolgem časovnem obdobju za oceno odziva z najmanj vsakim od 3 glavnih sistemskih zdravil, ki so na voljo.
The largest study IMP24011 (n=793) included patients (n=526) who were not controlled by, contraindicated to, or intolerant to two or more systemic therapies as judged from the patients’ histories of psoriasis treatment.
V vseh študijah je bil primarni cilj študije delež
In all studies, the primary endpoint was the proportion of patients with a ≥ 75% improvement in the Psoriasis Area and Severity Index score (a PASI 75 response) relative to baseline when assessed one week after a 12-week treatment course.
9 bolnikov z relativnim ≥ 75% izboljšanjem psoriaznih predelov in rezultatom indeksa resnosti (PASI 75 odziv) glede na izhodišče, ocenjeno teden dni po zaključku 12 tedenskega zdravljenja.
Secondary endpoints included the proportion of subjects who achieved a rating of Minimal or Clear on a static global assessment by the physician, the Overall Lesion Severity (OLS), the proportion of patients with a ≥ 50% improvement in 9 PASI score (a PASI 50 response) relative to baseline after 12 weeks of treatment, the time-course of mean PASI percentage improvement from baseline, improvement in the Dermatology Life Quality Index (DLQI), Psoriasis Symptom Assessment (PSA), the Physician’ s Global Assessment (PGA) of change, change in the PASI thickness component, and change in the body surface area affected.
Sekundarni cilj študij je vključeval delež oseb, ki so dosegle oceno minimalno ali čisto pri statičnem globalnem pregledu pri zdravniku, celokupno hudost lezij (OLS), delež bolnikov z relativnim ≥ 50% izboljšanjem PASI izvida (PASI 50 odziv) po 12 tednih zdravljenja, čas do dosege povprečnega izboljšanja PASI odziva glede na izhodišče, izboljšanje indeksa dermatološke kvalitete življanja (DLQI), oceno simptomov psoriaze (PSA), spremembo zdravniške globalne ocene (PGA), spremembo debeline komponent PASI in spremembo površine prizadetega predela telesa.
Table 1 Primary Endpoint:
Tabela 1 Primarni cilj študije:
Proportion of Subjects with ≥ 75% improvement in PASI after 12 weeks of Treatment (PASI 75) Efalizumab a
Delež bolnikov s ≥ 75% izboljšanjem PASI po 12 tednih zdravljenja (PASI 75) Efalizumab a Populacija bolnikov IMP24011
Placebo
Placebo 1, 0
Treatment Effect [95% CI]
mg/ kg/ teden Učinek zdravljenja [95% IZ]
27%
31% 27% b
Patients who are not controlled by,
Bolniki, ki niso bili nadzorovani, ki so imeli
27%
(n=529) [22%, 32%] 30% 27% (n=342) b
contraindicated to, or intolerant to two or more systemic therapies *
kontraindikacije za ali niso prenašali dveh ali več sistemskih terapij * a
p-values compared efalizumab with placebo using logistic regression including baseline PASI score, prior treatment for psoriasis and geographical region as covariates. b p < 0.001. * As judged from the patients’ histories of psoriasis treatments
p- vrednosti primerjave efalizumaba s placebom z uporabo logistične regresije vključno z izhodišnim PASI izvidom, predhodnim zdravljenjem psoriaze in geografsko regijo kot kovariablami. b p < 0. 001. * po presoji bolnikovega zdravljenja psoriaze v preteklosti
In all five studies, patients randomized to the Raptiva dose group achieved statistically significantly better responses than placebo on the primary endpoint (PASI 75 response) (see Table 2 below) and on all the secondary efficacy endpoints.
V vseh petih študijah so bolniki naključno zbrani v skupine, ki so prejemale Raptivo dosegli statistično pomembno boljše rezultate za primarni cilj študij (PASI 75 odziv) (glejte spodaj tabelo 2) in sekundarne cilje učinkovitosti, kot bolniki, ki so prejemali placebo.
Table 2 Primary Endpoint:
Tabela 2 Primarni cilj:
Proportion of Subjects with ≥ 75% improvement in PASI after 12 weeks of Treatment (PASI 75)
Delež bolnikov s ≥ 75% izboljšanjem PASI po 12 tednih zdravljenja (PASI 75) Efalizumab a Študija
Efalizumab a
Placebo
Study
1, 0
Placebo
mg/ kg/ teden
1.0 mg/ kg/ wk Treatment Effect [95% CI]
Učinek zdravljenja [95% IZ]
37% [28%, 46%]
%, 46%]
(n=264)
(n=529) b a
10 a IMP24011: p-values compared efalizumab with placebo using logistic regression including baseline PASI score, prior treatment for psoriasis and geographical region as covariates.
IMP24011: p- vrednosti primerjave efalizumaba s placebom z uporabo logistične regresije vključujoč izhodiščni PASI izvid, predhodno zdravljenje psoriaze in geografsko regijo kot kovariable.
Other studies: p-values compared each efalizumab group with placebo using Fisher’ s exact test within each study. b p < 0.001.
Druge študije: p- vrednosti primerjave vsake skupine z efalizumabom s placebom z uporabo Fisherjevega testa natančnosti znotraj vsake študije. b p < 0, 001. * Izdelovalec v študiji uporabljenega efalizumaba je Genentech.
Time to relapse (≥ 50% loss of improvement) was evaluated in Study ACD2058g and IMP 24011 for patients who were classified as responders (≥ 75% improvement on PASI) after 12 weeks of treatment.
10 V študiji ACD2058g in IMP24011 so ovrednotili čas do relapsa (≥50% izguba izboljšanja) za bolnike, ki so jih opredelili kot odzivne (≥75% izboljšanje PASI) po 12 tednih zdravljenja.
In study IMP24011, approximately half of the patients (46.8%) who were partial responders (50% to 74% improvement on PASI, similar to PGA good) after 12 weeks of Raptiva treatment achieved a PASI 75 response at week 24.
Srednji čas do relapsa med PASI odzivnimi bolniki je bil v razponu od 58 do 74 dni po zadnjem odmerku Raptive v začetnem obdobju zdravljenja. V študiji IMP24011, je približno polovica bolnikov (46, 8%), ki so bili delno odzivni (50% do 75% izboljšan PASI, podobno kot PGA - dobro) doseglo po 12 tednih zdravljenja z Raptivo PASI 75 odziv v 24 tednu.
After subcutaneous administration of efalizumab peak plasma concentrations are reached after 1- 2 days.
Po subkutani uporabi doseže efalizumab največjo plazemsko koncentracijo po 1- 2 dneh.
Comparison with intravenous data indicated an average bioavailability of about 50% at the recommended dose level of 1.0 mg/ kg/ wk subcutaneous.
Primerjava z intravenskimi podatki kaže, da je povprečna biološka uporabnost priporočenega subkutanega odmerka 1, 0 mg/ kg/ teden enaka 50%.
At the 1 mg/ kg/ wk dose level (with an initial dose of 0.7 mg/ kg the first week), mean efalizumab plasma trough values were 11.1±7.9 µg/ ml.
Pri odmerku 1 mg/ kg/ teden (z začetnim odmerkom 0, 7 mg/ kg prvi teden), so bile povprečne vrednosti efalizumaba v plazmi 11, 1 ± 7, 9 µg/ ml.
Measurements of volume of distribution of the central compartment after single intravenous doses were 110 ml/ kg at dose 0.03 mg/ kg and 58 ml/ kg at dose 10 mg/ kg.
Izmerjena volumna porazdelitve v centralnem kompartimentu po enkratnem intravenskem odmerku sta bila 110 ml/ kg pri odmerku 0, 03 mg/ kg in 58 ml/ kg pri odmerku 10 mg/ kg.
Mean steady state clearance is 24 ml/ kg/ day (range 5-76 ml/ kg/ day) at 1 mg/ kg/ week subcutaneous.
Povprečni očistek v stanju dinamičnega ravnovesja je 24 ml/ kg/ dan (razpon 5- 76 ml/ kg/ dan) pri odmerku 1 mg/ kg/ teden subkutano.
The elimination half-life was about 5.5-10.5 days at 1 mg/ kg/ week subcutaneous.
Razpolovni čas izločanja je bil približno 5, 5- 10, 5 dni pri odmerku 1 mg/ kg/ teden subkutano.
Tend at steady state is 25 days (range 13-35 days).
Tkon v stanju dinamičnega ravnovesja je 25 dni (razpon 13- 35 dni).
It appeared that the receptor mediated clearance of efalizumab was saturated when plasma efalizumab concentrations were above 1 μ g/ ml.
Pokazalo se je, da se od receptorja odvisni očistek efalizumaba nasiči, ko so plazemske koncentracije efalizumaba večje od 1 μg/ ml.
Antibodies to efalizumab were detected in only 6% of patients evaluated.
Protitelesa na efalizumab so odkrili pri samo 6% proučevanih bolnikov.
Inhibitory effects were observed on the humoral and T-cell dependent immune responses.
Inhibitorne učinke so opazili na humoralni in od T - celic odvisni imunski odziv.
No lymphomas were observed following 6 months treatment with an antibody analogue of efalizumab in a 6 months study with p53 +/ + wild type mice.
V 6 mesecev trajajoči študiji s p53+/ + tipom divjih miši, niso po 6 mesecih terapije z analogom protitelesa efalizumabu, opazili nobenih limfomov.
Polysorbate 20 Histidine Histidine hydrochloride monohydrate Sucrose
Prašek za raztopino za injiciranje: polisorbat 20 histidin histidinijev klorid monohidrat saharoza.
After reconstitution, an immediate use is recommended (see also section 6.4).
Po rekonstituciji priporočamo takojšnjo uporabo (glejte tudi poglavje 6. 4).
Physico-chemical stability of the reconstituted product has been shown for 24 hours at 2°C to 8°C.
Potrjena fizikalno - kemijska stabilnost rekonstituiranega zdravila je 24 ur pri temperaturi med 2°C in 8°C.
12 6.5 Nature and contents of container
12 6. 5 Vrsta ovojnine in vsebina
Reconstitution of the single- use vial with 1.3 ml of the supplied water for injections yields approximately 1.5 ml of solution to deliver 100 mg per 1 ml of Raptiva.
Po rekonstituciji viale za enkratno uporabo z 1, 3 ml priložene vode za injekcije nastane približno 1, 5 ml raztopine, kar zagotavlja odmerek Raptive 100 mg v 1 ml.
The maximum retrievable dose is 125 mg per 1.25 ml of Raptiva.
Maksimalni razpoložljivi odmerek Raptive je 125 mg v 1, 25 ml.
14 ANNEX II
13 DODATEK II
15 A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
1 DNA Way, South San Francisco, CA 94080-4990 USA
1 DNA Way, South San Francisco, CA 94080- 4990 ZDA
Via L.
Industria Farmaceutica Serono S. p. A Via L.
Einaudi 11, 00012 Guidonia Montecelio (Rome) Italy
Einaudi 11, 00012 Guidonia Montecelio (Rome) Italija
Not applicable.
15 DODATEK III
LABELLING
17 PODATKI NA ZUNANJI OVOJNINI
BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE BOX OF 4 VIALS AND 4 PRE-FILLED SYRINGES BOX OF 12 VIALS AND 12 PRE-FILLED SYRINGES
ŠKATLA Z 1 VIALO IN 1 NAPOLNJENO INJEKCIJSKO BRIZGO ŠKATLA S 4 VIALAMI IN 4 NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI ŠKATLA Z 12 VIALAMI IN 12 NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI
Raptiva 100 mg/ ml powder and solvent for solution for injection Efalizumab
Raptiva 100 mg/ ml prašek in vehikel za raztopino za injiciranje efalizumab
1 pre-filled syringe of 1.3 ml solvent.
1 napolnjena injekcijska brizga z 1, 3 ml vehikla.
4 pre-filled syringes of 1.3 ml solvent.
4 napolnjene injekcijske brizge z 1, 3 ml vehikla.
12 pre-filled syringes of 1.3 ml solvent.
12 napolnjenih injekcijskih brizg z 1, 3 ml vehikla.
Use immediately after reconstitution.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
INFORMATION IN BRAILLE
16 PODATKI V BRAILLOVI PISAVI
20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
19 PODATKI, KI OVOJNINAH
RAPTIVA 100 mg/ ml VIAL LABEL
RAPTIVA 100 mg/ ml NALEPKA NA VIALI
Raptiva 100 mg/ ml Powder for solution for injection Efalizumab Subcutaneous use
Raptiva 100 mg/ ml Prašek za raztopino za injiciranje efalizumab Za subkutano uporabo.
21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
20 PODATKI, KI OVOJNINAH
1.3 ml in pre-filled syringe
1, 3 ml v napolnjeni injekcijski brizgi.
What Raptiva is and what it is used for 2.
Kaj je zdravilo Raptiva in za kaj ga uporabljamo 2.
Before you use Raptiva 3.
Kaj morate vedeti, preden boste uporabili zdravilo Raptiva 3.
How to use Raptiva 4.
Kako uporabljati zdravilo Raptiva 4.
Possible side effects 5 How to store Raptiva 6.
Shranjevanje zdravila Raptiva 6.
Therapeutic indications 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.
Terapevtske indikacije Zdravljenje odraslih bolnikov z zmerno do hudo kronično psoriazo s plaki, ki se ne odzivajo na ali imajo kontraindikacije za oziroma ne prenašajo drugega sistemskega zdravljenja, vključno s ciklosporinom, metotreksatom in PUVA (psoraleni in ultravijolični žarki A).
- If you have or have had any cancer.
- Če imate ali ste imeli raka.
Symptoms that might indicate that
Znaki, ki lahko kažejo, da imate okužbo so