FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common: Fatigue, asthenia, pyrexia Common: Peripheral oedema, mucosal inflammation, pain, rigors, oedema, weakness, decreased performance status, chest pain, influenza-like illness, malaise, lethargy, hyperpyrexia
Slovenian: Zelo pogosti: utrujenost, astenija, pireksija Pogosti: periferni edem, vnetje sluznice, bolečine, okorelost, edem, šibkost, manjša zmogljivost, bolečine v prsih, gripi podobna bolezen, slabo počutje, letargija, hiperpireksija
English: Very common: Arthralgia, myalgia Common: Back pain, pain in extremity, musculoskeletal pain
Slovenian: Zelo pogosti: artralgija, mialgija Pogosti: bolečina v hrbtu, bolečina v udih, bolečina v mišicah in kosteh
English: Occurrence Dose of Abraxane (mg/m2)1
Slovenian: Pojavljanje Odmerek zdravila Abraxane (mg/m2)1
English: The recommended dose of Abraxane in combination with gemcitabine is 125 mg/m2 administered intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle.
Slovenian: Priporočeni odmerek zdravila Abraxane v kombinaciji z gemcitabinom je 125 mg/m2, ki se daje intravensko 30 minut 1., 8. in 15. dan vsakega 28-dnevnega cikla.
English: The usual dose is for breast cancer is 260 mg/m2 of body surface area given over a 30 minute period.
Slovenian: Običajni odmerek pri raku dojk je 260 mg/m2 telesne površine.
English: Talk to your doctor or nurse if you experience any of these conditions whilst being treated with Abraxane, your doctor may wish to stop treatment or reduce the dose:
Slovenian: Posvetujte se z zdravnikom ali medicinsko sestro, če se vam pojavijo katere koli od spodaj navedenih težav, medtem ko vas zdravijo z zdravilom Abraxane.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/428/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/28/002
English: Very common: Rash, alopecia Common: Pruritus, nail disorder Uncommon: Skin exfoliation, dermatitis allergic, urticaria
Slovenian: Zelo pogosti: izpuščaj, alopecija Pogosti: pruritus, bolezni nohtov Občasni: luščenje kože, alergijski dermatitis, urtikarija
English: Abraxane Dose (mg/m2)
Slovenian: Odmerek zdravila Abraxane (mg/m2)
English: The concurrent recommended dose of gemcitabine is 1000 mg/m2 administered intravenously over 30 minutes immediately after the completion of Abraxane administration on Days 1, 8 and 15 of each 28-day cycle.
Slovenian: Sočasni priporočeni odmerek gemcitabina je 1.000 mg/m2, ki se daje intravensko 30 minut takoj po končanem dajanju zdravila Abraxane 1., 8. in 15. dan vsakega 28-dnevnega cikla.
English: • Gas, stomach cramps, painful or sore gums, rectal bleeding
Slovenian: • vetrovi, trebušni krči, bolečine ali razjede na dlesnih, krvavenje iz danke
English: The uncommon side effects may affect up to 1 in 100 people:
Slovenian: Občasni neželeni učinki se lahko pojavijo pri največ 1 od 100 bolnikov:
English: Common: Lacrimation increased Uncommon: Cystoid macular oedema
Slovenian: Pogosti: zvečano solzenje Občasni: cistoidni makularni edem
English: There were no clinically relevant pharmacokinetic interactions between Abraxane and carboplatin.
Slovenian: Med zdravilom Abraxane in karboplatinom ni bilo klinično pomembnih farmakokinetičnih interakcij.
English: Erlotinib should not be coadministered with Abraxane plus gemcitabine (see section 4.5).
Slovenian: Erlotiniba ne smete dajati skupaj s kombinacijo zdravila Abraxane in gemcitabina (glejte poglavje
English: • Decreased phosphorus in the blood, fluid retention, low albumin in the blood, increased thirst,
Slovenian: • znižana raven fosforja v krvi, zadrževanje tekočine, znižana raven albumina v krvi, povečana žeja, znižana raven kalcija v krvi, znižana raven krvnega sladkorja, znižana raven natrija v krvi
English: • medicines used to treat HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz,
Slovenian: sakvinavir, indinavir, nelfinavir, efavirenz, nevirapin)
English: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Slovenian: Raztopina humanega albumina (vsebuje natrij, natrijev kaprilat in N-acetil DL triptofanat).
English: Table 3: Dose modifications for other adverse drug reactions in patients with pancreatic adenocarcinoma Adverse Drug Reaction (ADR)
Slovenian: Preglednica 3: Prilagajanje odmerka pri drugih neželenih učinkih zdravila pri bolnikih z adenokarcinomom trebušne slinavke
English: Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Abraxane.
Slovenian: Tako kot pri drugih potencialno toksičnih spojinah je treba tudi z zdravilom Abraxane previdno ravnati.
English: Abraxane was administered to patients (N=521) as an intravenous infusion over 30 minutes at a dose of 100 mg/m2 on Days 1, 8 and
Slovenian: Bolnikom (N=521) so dajali zdravilo Abraxane v obliki intravenske infuzije 30 minut v odmerku 100 mg/m2 1.,
English: Bone marrow suppression (primarily neutropenia) occurs frequently with Abraxane.
Slovenian: Pri zdravilu Abraxane pogosto pride do zavrtja delovanja kostnega mozga (večinoma nevtropenija).
English: This multi-centre trial was conducted in patients with metastatic breast cancer, who were treated every 3 weeks with single-agent paclitaxel, either as solvent-based paclitaxel 175 mg/m2 given as a 3-hour infusion with premedication to prevent hypersensitivity (N = 225), or as Abraxane 260 mg/m2 given as a
Slovenian: To raziskavo so izvedli v več centrih pri bolnikih z metastatskim rakom dojk, ki so vsake 3 tedne prejemali paklitaksel kot samostojno zdravilo, ali kot paklitaksel na bazi topila v odmerku 175 mg/m2
English: What Abraxane is
Slovenian: Kaj je zdravilo Abraxane
English: In general, the frequency and severity of neurotoxicity was dose-dependent in patients receiving Abraxane.
Slovenian: Na splošno je bila pri bolnikih, ki so prejemali zdravilo Abraxane, pogostnost in resnost nevrotoksičnosti odvisna od odmerka.
English: Rare: Cystoid macular oedema2
Slovenian: Redki: cistoidni makularni edem2
English: Some people may feel tired or dizzy after being given Abraxane.
Slovenian: Po uporabi zdravila Abraxane so lahko nekateri ljudje utrujeni ali omotični.
English: Abraxane(125 mg/m2)/
Slovenian: Zdravilo Abraxane (125 mg/m2)/ gemcitabin gemcitabin
English: Uncommon: Productive cough, exertional dyspnoea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing, pulmonary emboli, pulmonary thromboembolism
Slovenian: Občasni: produktiven kašelj, dispneja ob naporu, kongestija sinusov, plitvejši zvok dihanja, plevralni izliv, alergijski rinitis, hripavost, zamašitev nosu, suhost v nosu, piskanje v pljučih, pljučna embolija, pljučna trombembolija
English: Powder for suspension for infusion.
Slovenian: FARMACEVTSKA OBLIKA prašek za suspenzijo za infundiranje
English: Lung Cancer
Slovenian: Pljučni rak
English: Table 5: Dose reductions for non-haematologic toxicities in patients with non-small cell lung cancer Non-haematologic Toxicity
Slovenian: Preglednica 5: Zmanjšanje odmerka zaradi hematoloških toksičnosti pri bolnikih z nedrobnoceličnim pljučnim rakom
English: The rare side effects may affect up to 1 in 1,000 people:
Slovenian: Redki neželeni učinki se lahko pojavijo pri največ 1 od 1.000 bolnikov:
English: A multicenter, randomized, open-label study was conducted in 1052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer.
Slovenian: Pri 1.052 bolnikih z nedrobnoceličnim pljučnim rakom stadija IIIb/IV, ki prej še niso prejeli kemoterapije, so opravili multicentrično, randomizirano, odprto študijo.
English: (PT at Risk)
Slovenian: (navedeno v poglavju 6),
English: Each vial contains 100 mg or 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Slovenian: Ena viala vsebuje 100 mg ali 250 mg paklitaksela, vezanega na albuminske nanodelce.
English: Very common: Alopecia, rash Common: Pruritus, dry skin, nail disorder, flushing
Slovenian: Zelo pogosti: alopecija, izpuščaj Pogosti: pruritus, suha koža, bolezni nohtov, zardevanje
English: Common: Flushing, hot flushes, hypertension, lymphoedema Uncommon: Hypotension, peripheral coldness, orthostatic hypotension Rare: Thrombosis
Slovenian: Pogosti: zardevanje, vročinski oblivi, hipertenzija, limfedem Občasni: hipotenzija, občutek perifernega mrazenja, ortostatska hipotenzija
English: The very rare side effects may affect up to 1 in 10,000 people:
Slovenian: Zelo redki neželeni učinki se lahko pojavijo pri največ 1 od 10.000 bolnikov:
English: Patients received a median treatment duration of 3.9 months in the Abraxane/gemcitabine arm and 2.8 months in the gemcitabine arm. 32% of patients in the Abraxane/gemcitabine arm compared with 15% of patients in the gemcitabine arm received 6 or more months of treatment.
Slovenian: V skupini z zdravilom Abraxane/gemcitabinom je 32 % bolnikov prejelo 6 ali več mesecev zdravljenja, v skupini z gemcitabinom pa 15 %.
English: Hepatobiliary disorders Common: Cholangitis
Slovenian: Občasni: hepatomegalija
English: Solventbased paclitaxel was administered to patients (N=531) at a dose of 200 mg/m2 as an intravenous infusion over 3 hours with standard premedication, immediately followed by carboplatin administered intravenously at AUC = 6 mg•min/mL.
Slovenian: Paklitaksel na bazi topila so bolnikom (N=531) dali v odmerku 200 mg/m2 v obliki intravenske infuzije, ki je tekla 3 ure, s standardno premedikacijo, takoj nato je sledil
English: What Abraxane contains
Slovenian: Kaj vsebuje zdravilo Abraxane
English: Warnings and precautions Talk to your doctor or nurse before using Abraxane
Slovenian: Pred začetkom uporabe zdravila Abraxane se posvetujte z zdravnikom ali medicinsko sestro
English: *Median progression free survival [95% CI] (weeks)
Slovenian: *Mediana preživetja brez napredovanja bolezni [95 % IZ] (tedni)
English: Platelet count (cells/mm3)
Slovenian: Število krvnih ploščic (celice/mm3)
English: • Anxiety
Slovenian: • nemirnost
English: Pneumonitis has been reported at a rate of 4% with the use of Abraxane in combination with gemcitabine.
Slovenian: Pnevmonitis se je pojavil pri 4 % bolnikov, kadar so bolniki prejemali zdravilo Abraxane skupaj z gemcitabinom.
English: Reproductive system and breast disorders
Slovenian: Infekcijske in parazitske bolezni
English: Common: Vertigo Uncommon: Ear pain, tinnitus
Slovenian: Pogosti: vrtoglavica Občasni: bolečine v ušesih, tinitus
English: • Pain in the breast
Slovenian: • bolečine v prsih
English: Each vial contains 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Slovenian: Ena viala vsebuje 250 mg paklitaksela, vezanega na albuminske nanodelce.
English: Thus patients receiving Abraxane should be vigilantly monitored by physicians for the occurrence of cardiac events.
Slovenian: Zaradi pojavljanja težav pri delovanju srca morajo biti bolniki, ki jemljejo zdravilo Abraxane, pod strogim nadzorom zdravnikov.
English: Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of Abraxane.
Slovenian: V obdobju spremljanja zdravila Abraxane po začetku trženja so opazili paralizo kranialnih živcev, parezo glasilk in redke primere reakcij hude preobčutljivosti.
English: There was a statistically significant improvement in PFS for patients treated with Abraxane/gemcitabine versus gemcitabine alone, with 1.8 months increase in median PFS.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Abraxane/gemcitabinom, v primerjavi s tistimi, ki so se zdravili samo z gemcitabinom, se je preživetje brez napredovanja bolezni statistično značilno izboljšalo, mediano preživetje brez napredovanja bolezni se je podaljšalo za 1,8 meseca.
English: Reconstitution and administration of the product
Slovenian: Rekonstitucija in dajanje zdravila
English: Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 250 mg vial of Abraxane over a minimum of 1 minute.
Slovenian: S sterilno brizgo počasi injicirajte 50 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v 250 mg vialo z zdravilom Abraxane najmanj 1 minuto.
English: Rare: Radiation recall phenomenon, radiation pneumonitis
Slovenian: Redki: preobčutljivost predhodno obsevanih predelov, obsevalni pnevmonitis
English: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 100 mg vial of Abraxane over a minimum of 1 minute.
Slovenian: S sterilno brizgo počasi injicirajte 20 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v 100 mg vialo z zdravilom Abraxane najmanj 1 minuto.
English: • Increased weight, increased lactate dehydrogenase in the blood, decreased kidney function,
Slovenian: • zvečana telesna masa, povišana laktat dehidrogenaza v krvi, zmanjšana funkcija ledvic, povišan krvni sladkor, povišana vrednost fosforja v krvi
English: Overall Survival Number of deaths, n (%) Median OS (95% CI) (months) HRA/T (95.1% CI)
Slovenian: Celokupno preživetje število smrti, n (%) mediana celokupnega preživetja (95 % IZ) (meseci)
English: A pharmacokinetic study was conducted with Abraxane and carboplatin in non-small cell lung cancer patients.
Slovenian: Pri bolnikih z nedrobnoceličnim pljučnim rakom so opravili farmakokinetično študijo z zdravilom Abraxane in karboplatinom.
English: If Abraxane contacts mucous membranes, the membranes should be flushed thoroughly with water.
Slovenian: Če zdravilo Abraxane pride v stik s sluznico, jo takoj temeljito sperite z vodo.
English: When Abraxane is used as monotherapy, if Grade 3 sensory neuropathy develops, treatment should be withheld until resolution to Grade 1 or 2 followed by a dose reduction for all subsequent courses of Abraxane is recommended (see section 4.2).
Slovenian: Če se razvije senzorična nevropatija 3. stopnje, ko se zdravilo Abraxane uporablja kot monoterapija, je treba zdravljenje prekiniti, dokler se le-ta ne izboljša do 1. ali 2. stopnje.
English: Death or progression, n (%) Median PFS (95% CI) (months) HRA/T (95% CI)
Slovenian: smrt ali napredovanje bolezni, n (%) mediana preživetja brez napredovanja bolezni (95 % IZ) (meseci)
English: 250 mg vial: Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute.
Slovenian: Viala z 250 mg: S sterilno brizgo počasi injicirajte 50 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v vialo z zdravilom Abraxane najmanj 1 minuto.
English: For treatment of non-small cell lung cancer Abraxane is given once every week (i.e. on days 1, 8 and 15 of a 21 day cycle), with carboplatin being given once every three weeks (i.e. only on day 1 of each 21-day cycle), immediately after the Abraxane dose has been given.
Slovenian: 1., 8. in 15. dan 21-dnevnega cikla), skupaj s karboplatinom, ki se daje enkrat na tri tedne (t.j.
English: 100 mg vial: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute.
Slovenian: Viala s 100 mg: S sterilno brizgo počasi injicirajte 20 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v vialo z zdravilom Abraxane vsaj 1 minuto.
English: Administer Abraxane using an infusion set incorporating a 15 µm filter to avoid administration of these strands.
Slovenian: Da se boste izognili dajanju teh vlaken, dajajte zdravilo Abraxane z infuzijskim sistemom, ki vključuje 15 µm filter.
English: Very common: Nausea, diarrhoea, vomiting, constipation, abdominal pain, abdominal pain upper
Slovenian: Zelo pogosti: navzea, driska, bruhanje, zaprtost, bolečine v trebuhu, bolečina v zgornjem delu trebuha
English: Very common: Diarrhoea, vomiting, nausea, constipation
Slovenian: Zelo pogosti: slabost, driska, bruhanje, zaprtost, stomatitis
English: • Irritated eyes, painful eyes, red eyes, itchy eyes, double vision, reduced vision, or seeing flashing lights, blurred vision due to swelling of the retina (cystoid macular oedema)
Slovenian: • draženje oči, očesna bolečina, rdečina v očeh, srbenje oči, dvojni vid, poslabšanje vida,
English: Gemcitabine
Slovenian: Dojenje
English: How to store Abraxane
Slovenian: Shranjevanje zdravila Abraxane
English: Survival (months) Progression-free Survival Death or progression, n (%) Median Progression-free Survival, months (95% CI) HRA+G/G (95% CI)a P-valueb
Slovenian: Preživetje brez napredovanja bolezni Smrt ali napredovanje bolezni, n (%) Mediana preživetja brez napredovanja bolezni, meseci (95 % IZ)
English: • Abraxane is used together with a medicine called gemcitabine if you have metastatic cancer of the pancreas.
Slovenian: • Če imate metastatskega raka trebušne slinavke (pankreasa), se zdravilo Abraxane uporablja skupaj z zdravilom, ki se imenuje gemcitabin.
English: Population pharmacokinetic analysis for Abraxane included patients with ages ranging from 24 to 85 years old and shows that age does not significantly influence the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel.
Slovenian: Analiza kaže, da starost ne vpliva značilno na največjo hitrost izločanja paklitaksela in sistemsko izpostavljenost paklitakselu (AUC in Cmax).
English: Reduce doses 2 dose levels from Day 1 doses
Slovenian: Zmanjšajte odmerke za eno raven, nato dajte rastne faktorje belih krvnih celic ALI Zmanjšajte odmerke za dve ravni od odmerkov 1. dne
English: Grade 4 cutaneous toxicity, diarrhoea, or mucositis
Slovenian: Ukinite zdravljenje kožna toksičnost, driska ali mukozitis 4. stopnje prvo
English: Table 11: Efficacy results from randomized study in patients with pancreatic adenocarcinoma (Intent-to-treat population)
Slovenian: Preglednica 11: Rezultati učinkovitosti iz randomizirane študije pri bolnikih z adenokarcinomom trebušne slinavke (populacija z namenom zdravljenja) Zdravilo Abraxane (125 mg/m2)/gemcitabin (N=431)
English: • Indigestion, abdominal discomfort
Slovenian: • prebavne motnje, nelagodje v trebuhu
English: • Coughing with phlegm, shortness of breath when walking or climbing stairs, runny nose, or dry nose, decreased breath sounds, water on the lung, loss of voice, blood clot in the lung, dry throat
Slovenian: plitvejši zvok dihanja, voda v pljučih, izguba glasu, krvni strdek v pljučih, suho žrelo
English: patients with metastatic breast cancer.
Slovenian: minutno infuzijo pri 63 bolnikih z metastatskim rakom dojk.
English: Common: Stomatitis, dyspepsia, abdominal pain, dysphagia Hepatobiliary disordesrs Common: Hyperbilirubinaemia Skin and subcutaneous tissue disorders
Slovenian: Pogosti: bolečine v trebuhu, abdominalna distenzija, bolečine v zgornjem predelu trebuha, dispepsija, gastroezofagealna refluksna bolezen, oralna hipoestezija
English: Common: Pneumonia, bronchitis, upper respiratory tract infection, urinary tract infection
Slovenian: Pogosti: pljučnica, bronhitis, okužba zgornjih dihal, okužba sečil Občasni: sepsa, oralna kandidoza
English: Nadir platelets <50,000/mm3
Slovenian: Ukinite zdravljenje najmanjše število trombocitov <50.000/mm3
English: Resume Abraxane at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2).
Slovenian: Ko se periferna nevropatija izboljša na 0. ali 1. stopnjo, nadaljujte zdravljenje z zmanjšanim odmerkom zdravila Abraxane (glejte poglavje 4.2).
English: Very common: Nausea, diarrhoea, vomiting, constipation, stomatitis Common: Abdominal pain, abdominal distension, upper abdominal pain, dyspepsia, gastrooesophageal reflux disease, oral hypoaesthesia Uncommon: Dysphagia, flatulence, glossodynia, dry mouth, gingival pain, loose stools, oesophagitis, lower abdominal pain, mouth ulceration, oral pain, rectal haemorrhage
Slovenian: Občasni: disfagija, flatulenca, glosodinija, suha usta, boleče dlesni, mehko blato, ezofagitis, bolečine v spodnjem delu trebuha, ulceracija ust, bolečine v ustih, rektalno krvavenje
English: Very common: Insomnia, depression Common: Anxiety
Slovenian: Zelo pogosti: dehidracija, zmanjšan apetit, hipokaliemija Psihiatrične motnje Zelo pogosti: nespečnost, depresivnost Pogosti: anksioznost
English: 95% CI
Slovenian: Preživetje % (95 % IZ) pri
English: Celgene Europe B.V. Winthontlaan 6 N 3526 KV Utrecht Netherlands
Slovenian: Celgene Europe B.V.
English: Survival Rate % (95% CI) at 1 Year 2 Year 75th Percentile Overall
Slovenian: 75. percentil celokupnega preživetja (meseci)
English: Return to the Day 1 dose levels and follow with WBC Growth Factors OR Treat with same doses as Day 8 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000 Treat with Day 8 dose levels and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 8 doses
Slovenian: Zdravite z ravnijo odmerka 8. dne, nato dajte rastne faktorje belih krvnih celic ALI Zmanjšajte odmerke za eno raven od odmerkov 8. dne
English: The common side effects may affect up to 1 in 10 people:
Slovenian: Pogosti neželeni učinki se lahko pojavijo pri največ 1 od 10 bolnikov:
English: Common: Haemoptysis, epistaxis, cough
Slovenian: Pogosti: hemoptiza, epistaksa, kašelj Občasni: pnevmonitis3
English: Scleroderma of the skin has been reported.
Slovenian: Poročali so osklerodermiji.
English: Abraxane.
Slovenian: fenitoin)
English: 31 March 2026
Slovenian: 31. marca 2026
English: The clinical study report should be submitted to the relevant National Competent Authorities by:
Slovenian: Poročilo o klinični študiji je treba predložiti ustreznemu pristojnemu nacionalnemu organu do:
English: The study population should be representative for the authorised indication(s).
Slovenian: Študijska populacija mora biti reprezentativna za odobreno(-e) indikacijo(-e).
English: The protocols should be agreed with the relevant NCAs.
Slovenian: O protokolih se je treba dogovoriti s pristojnimi nacionalnimi organi.
English: Each MAH shall conduct and submit for their medicinal product(s) the results of placebo-controlled, double-blind multicentre RCT(s) according to agreed protocols in order to further characterise the efficacy and safety, of their bacterial lysate based product(s) in their authorised indication(s).
Slovenian: Vsak imetnik dovoljenja za promet z zdravilom mora za nadaljnjo opredelitev učinkovitosti in varnosti svojih zdravil na osnovi bakterijskih lizatov pri odobreni(-h) indikaciji(-ah) izvesti s placebom nadzorovana, dvojno slepa, multicentrična randomizirana klinična preskušanja po dogovorjenih protokolih in predložiti njihove rezultate.
English: The marketing authorisation holders shall complete the below condition, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled:
Slovenian: Imetniki dovoljenja za promet z zdravilom izpolnijo spodnji pogoj v navedenem roku, pristojni organi pa zagotovijo, da je izpolnjeno naslednje:
English: The product is currently approved in Sweden, Denmark, Finland, Iceland and Norway.
Slovenian: Zdravilo je trenutno odobreno na Švedskem, Danskem, Finskem, Islandiji in Norveškem.
English: This program is on-going and overall from 01 September 2009 to 30 June 2011, 12,830 women have been exposed.
Slovenian: Ta program še poteka in od 1. septembra 2009 do 30. junija 2011 je bilo zdravljenju izpostavljenih 12 830 žensk.
English: This protocol has been designed to provide further reassurance of the safety and efficacy of the product.
Slovenian: Ta protokol je bil zasnovan tako, da dodatno zagotovi varnost in učinkovitost zdravila.
English: The success rate is of 97.3%, comparable to studies reported in published literature.
Slovenian: Stopnja uspešnosti je bila 97,3 %, kar je primerljivo s študijami, o katerih poročajo v objavljeni literaturi.
English: The results of these trials show a very high success rate and no unexpected adverse events.
Slovenian: Rezultati teh preskušanj so pokazali zelo visoko stopnjo uspešnosti in nič nepričakovanih neželenih dogodkov.
English: • The Committee considered the notification of the referral triggered by France under Article 29(4) of Council Directive 2001/83/EC;
Slovenian: • Odbor je obravnaval obvestilo o napotitvenem postopku, ki jo je sprožila Francija v skladu s členom 29(4) Direktive Sveta 2001/83/ES.