FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dosage of Blitzima for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Slovenian: Priporočeni odmerek zdravila Blitzima za zdravljenje navadnega pemfigusa je 1.000 mg v intravenski infuziji, ki ji čez dva tedna sledi druga intravenska infuzija 1.000 mg; uporablja se v kombinaciji z glukokortikoidi, katerih odmerke postopoma zmanjšujemo.
English: , weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia
Slovenian: Presnovne in prehranske motnje hiperglikemija, zmanjšanje telesne mase, periferni edem, edem obraza, zvišanje LDH, hipokalciemija
English: Musculoskelet al, connective tissue and bone disorders hypertonia, myalgia, arthralgia, back pain, neck pain, pain
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva hipertonija, mialgija, artralgija, bolečina v hrbtu, bolečina v vratu, bolečina
English: Infusion-related reactions in the pemphigus vulgaris clinical study were common (58%).
Slovenian: V klinični študiji pri navadnem pemfigusu so bile z infundiranjem povezane reakcije pogoste (58%).
English: Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes.
Slovenian: Rituksimab se veže specifično na transmembranski antigen, CD20, neglikoziliran fosfoprotein, ki se nahaja na limfocitih pre-B in dozorelih limfocitih B. Antigen je izražen pri > 95 % vseh B-celičnih neHodgkinovih limfomov.
English: Of
Slovenian: a
English: The recommended dose of Blitzima in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
Slovenian: Priporočeni odmerek zdravila Blitzima v kombinaciji s kemoterapijo za indukcijsko zdravljenje bolnikov s folikularnimi limfomi, ki se predhodno še niso zdravili ali se na prejšnje zdravljenje niso odzvali ali se jim je bolezen ponovila, je: 375 mg/m telesne površine na cikel do 8 ciklov.
English: You should also tell them about your Blitzima treatment.
Slovenian: Povejte, da se zdravite z zdravilom Blitzima.
English: Blitzima is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Slovenian: Rituksimab je bistra brezbarvna tekočina v sterilnih vialah za enkratno uporabo, apirogena in brez konzervansov.
English: ORR in patients previously treated with autologous bone marrow transplant (ABMT) was 78% versus 43% in patients with no ABMT.
Slovenian: Celokupen odgovor pri bolnikih s predhodno avtologno presaditvijo kostnega mozga je znašal 78% v primerjavi s 43% pri bolnikih brez avtologne presaditve kostnega mozga.
English: Although rituximab is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited.
Slovenian: Čeprav zdravilo rituksimab pri samostojnem zdravljenju ne deluje mielosupresivno, je potrebna previdnost pri bolnikih, ki imajo število nevtrofilcev < 1,5 x 10
English: Mean Cmax for serum rituximab following first infusion was 170 to 175 μg/mL for 2 × 500 mg dose and 317 to 370 μg/mL for 2 × 1000 mg dose.
Slovenian: Povprečna serumska Cmax rituksimaba po prvi infuziji je bila 170 do 175 μg/ml za 2 x 500 mg odmerek ter 317 do 370 μg/ml za 2 x 1000 mg odmerek.
English: Very rare side effects (may affect up to 1 in 10,000 people):
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri 1 od 10.000 bolnikov): huda stanja z mehurji na koži, ki so lahko življenjsko ogrožujoča.
English: It sticks to the surface of a type of white blood cell called “B-Lymphocyte”.
Slovenian: Veže se na površino vrste belih krvnih celic, limfocitov B. Ko se veže na površino teh celic, rituksimab povzroči njihovo smrt.
English: Binet stage A Binet stage B Binet stage C CI: Confidence Interval In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log-rank test).
Slovenian: V študiji pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, je bila mediana preživetja brez napredovanja bolezni (primarna končna točka) 30,6 meseca v skupini R-FC in 20,6 meseca v skupini FC (p=0,0002, test log rank).
English: Studies in previously untreated and relapsed/refractory CLL have established that in up to 25% of patients treated with R-FC neutropenia was prolonged (defined as neutrophil count remaining below 1x109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1x109/L later than 42 days after last dose in patients with no previous prolonged neutropenia or who recovered prior to day 42) following treatment with rituximab plus FC.
Slovenian: V študijah pri bolnikih s KLL, ki še niso bili zdravljeni in pri bolnikih s KLL, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, so ocenili, da je bila pri do 25% bolnikov zdravljenih z R-FC nevtropenija podaljšana (opredeljena kot število nevtrofilcev, ki med dnevoma 24 in 42 po zadnjem prejetem odmerku ostane pod 1x10
English: How to store Blitzima
Slovenian: Kako se daje zdravilo Blitzima
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following rituximab treatment, as appropriate according to local clinical practice guidelines.
Slovenian: Pri bolnikih z granulomatozo s poliangiitisom, mikroskopskim poliangiitisom ali navadnim pemfigusom je med zdravljenjem z zdravilom Blitzima in po njem priporočljiva profilaksa proti pljučnici, ki jo povzroča Pneumocystis jirovecii, kot je ustrezno glede na lokalne smernice klinične prakse.
English: • heart failure
Slovenian: Srčne bolezni
English: Higher frequencies of infections overall, including grade 3 or 4 infections, were observed during rituximab maintenance treatment up to 2 years when compared to observation.
Slovenian: V primerjavi z opazovano skupino so med največ dveletnim vzdrževalnim zdravljenjem z rituksimabom opazili večjo pogostnost okužb na splošno, vključno z okužbami 3. ali 4. stopnje.
English: In the pivotal trial, 166 patients with relapsed or chemoresistant low-grade or follicular B cell NHL received 375 mg/m2 of rituximab as an intravenous infusion once weekly for four weeks.
Slovenian: V ključnem preskušanju je 166 bolnikov, pri katerih se je nizko maligni ne-Hodgkinov limfom ali folikularni B-celični ne-Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo, 4 tedne prejemalo po 375 mg/m rituksimaba v obliki intravenske infuzije enkrat na teden.
English: What Blitzima is used for
Slovenian: Za kaj uporabljamo zdravilo Blitzima
English: Significant difference from placebo + MTX at the primary time point: ***p ≤ 0.0001
Slovenian: † Odziv po 24 tednih (študija 1 in 2) Značilna razlika v primerjavi s kombinacijo placebo + metotreksat ob času primarnega cilja preskušanja: ***p ≤ 0,0001
English: During rituximab maintenance treatment for up to 2 years, leucopenia (5% vs. 2%, grade 3/4) and neutropenia (10% vs. 4%, grade 3/4) were reported at a higher incidence when compared to observation.
Slovenian: Incidenci levkopenije in nevtropenije 3. ali 4. stopnje sta bili v skupini, ki je prejemala vzdrževalno zdravljenje z rituksimabom do 2 leti, višja (levkopenija: 5%, nevtropenija: 10%) kot v opazovani skupini (levkopenija: 2%, nevtropenija: 4 %).
English: A total of 197 patients aged 15 years or older with severe active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicentre, non-inferiority trial.
Slovenian: V randomiziranem, dvojno slepem, s placebom kontroliranem multicentričnem preskušanju neinferiornosti z aktivnim primerjalnim zdravilom so vključili in v njej zdravili skupno 197 bolnikov, starih 15 let ali več s hudo, aktivno granulomatozo s poliangiitisom (75%) in mikroskopskim poliangiitisom (24 %).
English: Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients from clinical study up to month 24
Slovenian: Neželeni učinki iz klinične študije pri bolnikih z navadnim pemfigusom, zdravljenih z zdravilom Rituksimab do 24. meseca
English: The recommended dose of Blitzima used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total).
Slovenian: • Ponovitev folikularnih limfomov ali neodzivna bolezen Priporočeni odmerek zdravila Blitzima za vzdrževalno zdravljenje bolnikov s ponovitvijo folikularnih limfomov ali neodzivno boleznijo, ki so se odzvali na indukcijsko zdravljenje, je: 375 mg/m telesne površine enkrat na 3 mesece (z začetkom 3 mesece po zadnjem odmerku indukcijskega zdravljenja) do napredovanja bolezni ali največ dve leti (skupaj 8 infuzij).
English: Table 10a First-line treatment of chronic lymphocytic leukaemia Overview of efficacy results for rituximab plus FC vs. FC alone - 48.1 months median observation time Efficacy Parameter
Slovenian: Pregled rezultatov o učinkovitosti za rituksimab v kombinaciji s kemoterapijo FC v primerjavi s samo kemoterapijo FC - mediana opazovanja 48,1 meseca.
English: General disorders and administratio n site conditions fever, chills, asthenia, headache tumour pain, flushing, malaise, cold syndrome, +fatigue, +shivering, +multi-organ failure4
Slovenian: Splošne težave in spremembe na mestu aplikacije zvišana telesna temperatura, mrzlica, astenija, glavobol tumorska bolečina, zardevanje, splošno slabo počutje, prehladni sindrom, +utrujenost, +drgetanje, +
English: Blitzima is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Slovenian: Zdravilo Blitzima se uporablja za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
English: Rituximab was administered as an intravenous infusion at a first-cycle dose of 375 mg/m2 increased to 500 mg/m2 each cycle for 5 doses in combination with fludarabine and cyclophosphamide in CLL patients.
Slovenian: Kronična limfocitna levkemija Rituksimab so bolnikom s KLL dajali v obliki intravenske infuzije v odmerku 375 mg/m telesne površine v prvem ciklu zdravljenja, odmerek pa se je v naslednjih 5 ciklih zdravljenja povečal na 500 mg/m telesne površine (v kombinaciji s fludarabinom in ciklofosfamidom).
English: Blitzima 500 mg concentrate for solution for infusion
Slovenian: Blitzima 500 mg koncentrat za raztopino za infundiranje
English: You must also do this for 12 months after your last treatment with Blitzima.
Slovenian: Učinkovito kontracepcijsko zaščito morate nadaljevati še 12 mesecev po zadnjem odmerku zdravila Blitzima.
English: Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients in the clinical study up to month 24 System Organ Class
Slovenian: Neželeni učinki iz klinične študije pri bolnikih z navadnim pemfigusom, zdravljenih z zdravilom Rituksimab do 24. meseca Organski sistem Neželeni učinek
English: Nervous system disorders
Slovenian: Bolezni živčevja omotica tremor
English: Experience from granulomatosis with polyangiitis and microscopic polyangiitis
Slovenian: Izkušnjeprigranulomatoza s poliangiitisom in mikroskopski poliangiitis
English: Complete response (CR/CRu) rate* 48% 67% 53% 67% chi-squared test p value odds ratio (95% CI)
Slovenian: Delež popolnega odgovora (CR/CRu)* vrednost p v testu hi-kvadrat razmerje obetov (95-% IZ)
English: Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving rituximab for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group
Slovenian: Neželeni učinki, ki so se pojavili pri ≥ 5 % bolnikov, ki so prejeli rituksimab za vzdrževalno zdravljenje GPA in MPA in pogosteje kot v primerjalni skupini
English: Skin and Subcutaneous tissue disorders pruritus, rash, +alopecia urticaria, sweating, night sweats, +skin disorder severe bullous skin reactions, StevensJohnson syndrome toxic epidermal necrolysis (Lyell's syndrome)7
Slovenian: Bolezni kože in podkožja srbenje, izpuščaj, +alopecija urtikarija, znojenje, nočno znojenje, +bolezen kože hude bulozne kožne reakcije, Stevens
English: Influenza-like illness Oedema peripheral
Slovenian: Splošne težave in spremembe na mestu aplikacije periferni edemi
English: At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32%.
Slovenian: Nadaljnja analiza trajanja celokupnega preživetja, ki so jo izvedli po mediani časa sledenja 60 mesecev, je potrdila prednost zdravljenja z R-CHOP pred CHOP (p = 0,0071), kar pomeni zmanjšanje tveganja za dogodke za 32 %.
English: The overall rate of infection was approximately 94 per 100 patient years in rituximab treated patients.
Slovenian: Pri bolnikih, ki so se zdravili z rituksimabom, je bil celokupni delež okužb približno 94 na 100 bolnik-let.
English: Blitzima is a clear, colourless solution, supplied as a concentrate for solution for infusion in a glass vial.
Slovenian: Na voljo je v obliki koncentrata za raztopino za infundiranje v stekleni viali.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: In a multicentre, single-arm trial, 37 patients with relapsed or chemoresistant, low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for eight doses.
Slovenian: V multicentričnem preskušanju brez primerjalne skupine je 37 bolnikov, pri katerih se je nizko maligni ne-Hodgkinov limfom ali folikularni B-celični ne-Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo, prejemalo osem odmerkov po 375 mg/m rituksimaba v obliki intravenske infuzije enkrat na teden.
English: For retreatment with Blitzima monotherapy for patients who have responded to previous treatment with Blitzima monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (see section 5.1).
Slovenian: Priporočeni odmerek zdravila Blitzima za ponovno samostojno zdravljenje bolnikov s folikularnim limfomom, ki so se odzvali na prejšnje samostojno zdravljenje z zdravilom Blitzima po tem, ko se na predhodno zdravljenje niso odzvali ali se je pri njih bolezen ponovila, je: 375 mg/m telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne (glejte poglavje 5.1).
English: Table 9 Maintenance phase: overview of efficacy results rituximab vs. observation (28 months median observation time)
Slovenian: Vzdrževalno zdravljenje: pregled učinkovitosti zdravljenja z rituksimabom v primerjavi z opazovanjem (mediana časa opazovanja 28 mesecev) Parameter učinkovitosti
English: Blitzima 100 mg concentrate for solution for infusion
Slovenian: Blitzima 100 mg koncentrat za raztopino za infundiranje
English: You will always be given Blitzima as a drip (intravenous infusion).
Slovenian: Zdravilo Blitzima boste dobili v intravenski infuziji.
English: For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Blitzima to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Slovenian: 9/l, je za zmanjšanje pogostnosti in resnosti akutnih reakcij, povezanih z infuzijo, in/ali sindroma sproščanja citokinov priporočljivo intravensko dati 100 mg prednizona/prednizolona malo pred infuzijo zdravila Blitzima.
English: Gastrointesti nal disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intestin al perforation7
Slovenian: Bolezni prebavil navzea bruhanje, driska, bolečine v trebuhu, disfagija, stomatitis, zaprtost, dispepsija, neješčnost, draženje žrela povečanje trebuha perforacija prebavil7
English: Treatment with Blitzima uses four separate infusions given at weekly intervals.
Slovenian: c) Če se zdravite zaradi granulomatoze s poliangiitisom ali mikroskopskega poliangiitisa Zdravljenje z zdravilom Blitzima obsega štiri ločene infuzije, ki jih dobite v presledkih enega tedna.
English: Baseline CD19-positive cell counts and size of measurable tumour lesions contributed to some of the variability in CL2 of rituximab in data from 161 patients given 375 mg/m2 as an intravenous infusion for 4 weekly doses.
Slovenian: K variabilnosti Cl2 rituksimaba pri 161 bolnikih, ki so v štirih tednih enkrat na teden dobili 375 mg/m rituksimaba z intravensko infuzijo, je prispevalo začetno število CD19 pozitivnih celic in velikost izmerljivih tumorskih lezij.
English: The MAH must ensure that all physicians who are expected to prescribe Blitzima are provided with the following:
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da zdravniki, ki lahko predpišejo zdravilo Blitzima, prejmejo: povzetek glavnih značilnosti zdravila, gradivo za zdravnika
English: PFS
Slovenian: (DFS)
English: OS
Slovenian: IZ
English: • If you are having Blitzima alone Blitzima will be given to you once a week for 4 weeks.
Slovenian: Koliko zdravila boste dobili in kako pogosto a) Če se zdravite zaradi ne-Hodgkinovega limfoma Če prejemate samo zdravilo Blitzima, ga boste prejeli enkrat na teden 4 tedne.
English: A total of 23/99 (23%) rituximab-treated patients from the induction of remission trial tested positive for ADA by 18 months.
Slovenian: Do 18. meseca je imelo pozitiven izvid ADA skupno 23 od 99 (23 %) bolnikov, ki so bili v preskušanju zdravljeni z rituksimabom.
English: Do not breast-feed while you are being treated with Blitzima.
Slovenian: Med zdravljenjem z zdravilom Blitzima ne smete dojiti.
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Blitzima (Rituximab) Alert Card for patients with non-oncology diseases Why have I been given this card?
Slovenian: Opozorilna kartica za bolnike, ki prejemajo zdravilo Blitzima (rituksimab) za neonkološke bolezni
English: Rituximab + Prednisone N=38
Slovenian: Rituksimab + majhen odmerek prednizona (n = 38)
English: The recommended dose of Blitzima monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks.
Slovenian: • Bolniki, ki se na prejšnje zdravljenje niso odzvali ali se je pri njih bolezen ponovila Priporočeni odmerek zdravila Blitzima za samostojno indukcijsko zdravljenje odraslih bolnikov s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat ponovila, je: 375 mg/m telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne.
English: This medicine may make you more likely to get infections.
Slovenian: Ker prejemate zdravilo Blitzima, je večja verjetnost, da dobite okužbo.
English: Blitzima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Slovenian: Navadni pemfigus (pemphigus vulgaris) Zdravilo Blitzima je indicirano za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
English: • low mood and loss of interest or enjoyment in doing things, feeling nervous
Slovenian: - zmedenost, izgubo spomina ali težave pri mišljenju,
English: Blitzima 500 mg concentrate for solution for infusion Rituximab
Slovenian: Blitzima 500 mg koncentrat za raztopino za infundiranje rituksimab
English: Complete response (CR/CRu) rate* 48% 67% 53% 67% chi-squared test p value odds ratio (95% CI) * at end of maintenance/observation; final analysis results based on median follow-up of 73 months.
Slovenian: vrednost p v testu log-rang razmerje ogroženosti (95-% IZ) zmanjšanje tveganja Delež celokupnega odgovora* vrednost p v testu hi-kvadrat razmerje obetov (95-% IZ) Delež popolnega odgovora (CR/CRu)* vrednost p v testu hi-kvadrat razmerje obetov (95-% IZ)
English: Very rare disorders
Slovenian: Organski sistem Zelo pogosti
English: • heart problems - such as reduced heart rate or chest pain (angina)
Slovenian: težave s srcem - na primer upočasnjen srčni utrip ali bolečina v prsih (angina pektoris), astma, telesne organe doseže premalo kisika, oteklost trebuha.
English: This is because side effects can develop several months after you have had treatment.
Slovenian: Kartico pri sebi hranite še 2 leti po zadnjem odmerku zdravila Blitzima, ker se lahko neželeni učinki pojavijo več mesecev po zdravljenju.
English: Blitzima 100 mg concentrate for solution for infusion Rituximab
Slovenian: Blitzima 100 mg koncentrat za raztopino za infundiranje rituksimab
English: Psychiatric Disorders
Slovenian: Psihiatrične motnje nespečnost
English: Posology
Slovenian: Rituksimab
English: Medicines given before each Blitzima administration
Slovenian: Shranjevanje zdravila Blitzima
English: Pemphigus vulgaris
Slovenian: Deutschland Mundipharma GmbH
English: Physician information
Slovenian: FARMAKOLOŠKE LASTNOSTI
English: Hypertension Flushing
Slovenian: Žilne bolezni hipertenzija napadi rdečice
English: Patient Alert card
Slovenian: BESEDILO OPOZORILNE KARTICE ZA BOLNIKA Z NEONKOLOŠKO INDIKACIJO
English: • blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri do 1 od 100 bolnikov): motnje strjevanja krvi, zmanjšano nastajanje rdečih krvnih celic in povečano propadanje rdečih krvnih celic (aplastična hemolitična anemija), oteklost ali povečanje bezgavk, slabo razpoloženje in izguba zanimanja ali veselja za početje stvari, živčnost, motnje okušanja - na primer spremenjen okus stvari,
English: The Ph. Eur.
Slovenian: Ph. Eur.
English: At the conclusion of the assessment phase of the procedure the concerned Member State Poland was prepared to grant an authorisation.
Slovenian: Ob koncu faze vrednotenja v postopku je bila zadevna država članica Poljska pripravljena odobriti dovoljenje.
English: In addition, reports of the field studies were provided.
Slovenian: Poleg tega so bila predložena poročila o terenskih študijah.
English: The product has been authorised in the reference Member State (Slovak Republic) for 7 years.
Slovenian: Zdravilo je bilo 7 let odobreno v referenčni državi članici (Slovaški).
English: Murgašova 5 949 01 Nitra Slovak
Slovenian: Murgašova 5 949 01 Nitra Slovaška
English: Assessment of Quality and Efficacy issues
Slovenian: Vrednotenje vprašanj glede kakovosti in učinkovitosti
English: Pigs Intramuscularly deep into the neck muscle.
Slovenian: Prašiči Intramuskularno, globoko v vratno mišico.
English: (0062) allows levels residual formaldehyde above 0.5 g/L provided the level has been shown to be safe.
Slovenian: (0062) dovoljuje ravni preostanka formaldehida nad 0,5 g/L pod pogojem, da je ta raven dokazano varna.
English: In addition to these quality points Spain also considered that the permitted level of residual formaldehyde was too high.
Slovenian: Poleg teh vprašanj glede kakovosti je Španija menila, da so dovoljene ravni preostanka formaldehida previsoke.
English: The present referral follows an application for mutual recognition of the product in Poland and Spain.
Slovenian: Ta napotitveni postopek sledi vlogi za medsebojno priznavanje zdravila na Poljskem in v Španiji.
English: The conditions for lifting the suspension are set out in Annex III.
Slovenian: Pogoji za preklic zadržanja so določeni v Dodatku III.