FrancophonIA/ELRC3.0 huggingface dataset:
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with capecitabine
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m2 pri raku dojke v kombinaciji s kapecitabinom
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² in combination with cisplatin
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m2 pri nedrobnoceličnem pljučnem raku v kombinaciji s cisplatinom
English: Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion docetaxel
Slovenian: Docetaksel Teva 20 mg/0,72 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
English: Anaemia (G3/4: 3%); Neutropenia (G3/4:
Slovenian: Bolezni krvi in limfatičnega sistema anemija (S 3/4: 3 %), nevtropenija (S 3/4:
English: • The solvent for Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Slovenian: • Viala z vehiklom zdravila Docetaksel Teva 20 mg/0,72 ml vialo je 6 ml viala iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
English: Myalgia (severe: 0.5%)
Slovenian: zaprtost (huda: 0,2 %),
English: Myalgia (G3/4: 0.7%); Arthralgia (G3/4:
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija (S 3/4: 0,7 %), artralgija (S 3/4: 0,2 %)
English: Hepatobiliary disorders
Slovenian: ezofagitis / disfagija /
English: Vomiting (G3/4:
Slovenian: nevrotoksičnost (S3/4:
English: • The solvent for Docetaxel Teva 80 mg/2.88 ml vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Slovenian: • Viala z vehiklom zdravila Docetaksel Teva 80 mg/2,88 ml vialo je 15 ml viala iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
English: G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
Slovenian: Docetaksel so aplicirali v enourni infuziji, vsa ostala zdravila pa v intravenskem bolusu prvi dan. Bolnice, ki so doživele zapleteno nevtropenijo (febrilna nevtropenija, dolgotrajna nevtropenija ali okužba), so kot sekundarno profilakso dobile G-CSF.
English: Blood and lymphatic Neutropenia (G3/4:
Slovenian: Bolezni krvi in nevtropenija (S 4:
English: min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Slovenian: Druga je na 3 tedne dobivala docetaksel 75 mg/m2 v enourni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ml.min) v 30-60 minutah, tretja pa na 4 tedne vinorelbin (VCis) 25 mg/m2 v 6-10 minutah 1., 8.,
English: Lymphoedema
Slovenian: OVOJNINAH
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² single agent
Slovenian: Tabelarični prikaz neželenih učinkov monoterapije z zdravilom Docetaksel 100 mg/m2 pri raku dojke
English: Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%)
Slovenian: Bolezni prebavil driska (S 3/4: 19,7 %), navzeja (S 3/4: 16 %), stomatitis (S 3/4: 23,7 %), bruhanje (S 3/4: 14,3 %)
English: Hypersensitivity (G3/4: 0.6%)
Slovenian: Bolezni imunskega sistema preobčutljivost (S 3/4: 0,6 %)
English: Docetaxel in combination with platinum agents in chemotherapy-naïve patients
Slovenian: Zdravilo Docetaksel Teva v kombinaciji s platinskimi zdravili pri bolnikih, ki se še niso zdravili s kemoterapijo
English: • haemorrhage
Slovenian: Žilne bolezni
English: Dysgeusia/Parosmia (G3/4: 0.4%);
Slovenian: dispepsija (S 3/4: 0,8 %),
English: Infection (G3/4: 5.7%)
Slovenian: Infekcijske in parazitske bolezni okužba (S 3/4: 5,7 %)
English: Peripheral sensory neuropathy (G3/4: 1.2%);
Slovenian: Bolezni živčevja periferna senzorična nevropatija (S 3: 4,1 %),
English: Infections and infestations
Slovenian: Infekcijske in parazitske bolezni nevtropenična okužba,
English: Posology
Slovenian: PAKIRANJE
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Slovenian: (S 3/4: 1,2 %) disgevzija (S 3/4: 0 %)
English: G3/4 ALT increased
Slovenian: povišanje ravni ALT S
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - CONCENTRATE 20 mg/0.72 ml
Slovenian: NALEPKA NA VIALI - KONCENTRAT 20 mg/0,72 ml
English: What Docetaxel Teva looks like and contents of the pack: Docetaxel Teva concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution.
Slovenian: koncentrat in vehikel za raztopino za infundiranje Koncentrat je bistra, viskozna, rumena do rjavorumena raztopina.
English: p=
Slovenian: ***vrednost p
English: Epistaxis (G3/4: 0%);
Slovenian: (S 3/4: 0 %)
English: Gastrointestinal haemorrhage (severe:
Slovenian: zvečano solzenje (S
English: In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels
Slovenian: Pri bolnikih, ki se zdravijo s 100 mg docetaksela/m2 v monoterapiji, ki imajo serumski transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno ZMRO in hkrati zvišano serumsko alkalno fosfatazo nad
English: • fever or chills
Slovenian: • povišana telesna temperatura ali mrzlica;
English: Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija (S 3/4: 63 %), anemija (S 3/4: 10 %)
English: Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija (S 3/4: 0,3 %), mialgija (S 3/4: 0,3 %)
English: Myalgia
Slovenian: Limfedem
English: In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup period was observed to be ongoing in 49 patients (9.2%) in TAC arm and 35 patients (6.7%) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9%) in TAC arm and 30 patients (5.8%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Slovenian: V študiji GEICAM 9805 so nadaljnjo prisotnost alopecije, ki se je začela med obdobjem zdravljenja in je trajala v obdobje spremljanja zabeležili pri 49 bolnicah (9,2 %) v kraku TAC in pri 35 bolnicah (6,7 %) v kraku FAC.
English: Number of patients Median survival (months) 95% CI
Slovenian: (95-odstotni interval zaupanja) srednji čas preživetja (meseci) (95-odstotni interval zaupanja)
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
English: Lacrimation increased; Conjunctivitis
Slovenian: Očesne bolezni močnejše solzenje, konjunktivitis
English: Constipation (G3/4: 0.4%)
Slovenian: zaprtost (S 3/4: 0,4 %)
English: Fatigue/ weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija (S 3/4: 3 %), pireksija (S 3/4: 1 %), utrujenost/šibkost (S 3/4: 5 %), periferni edem (S 3/4: 1 %)
English: Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion docetaxel
Slovenian: Docetaksel Teva 80 mg/2,88 ml koncentrat in vehikel za raztopino za infundiranje docetaksel
English: Neutropenia (G3/4: 83.5%); Anaemia (G3/4: 12.4%); Thrombocytopenia (G3/4: 4.0%);
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija (S 3/4: anemija (S 3/4: 12,4 %), trombocitopenija (S 3/4:
English: In study TAX316 asthenia that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 236 of 744 TAC patients (31.7%) and 180 of 736 FAC patients (24.5%).
Slovenian: V študiji TAX316 so astenijo, ki se je pojavila med obdobjem zdravljenja in je trajala še med obdobjem spremljanja po koncu kemoterapije, zabeležili pri 236 od 744 bolnicah v kraku TAC (31,7
English: Peripheral sensory neuropathy (G3/4: 8.7%)
Slovenian: Bolezni živčevja periferna senzorična nevropatija (S 3: 3,7 %),
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to
Slovenian: Za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) (neresektabilen, majhna verjetnost kirurške ozdravitve, namen ohranitve organa) je priporočeni odmerek docetaksela 75 mg/m2 v enourni intravenski infuziji prvi dan, ki mu sledi cisplatin 100 mg/m2 v 30-minutni do 3-urni infuziji in nato neprekinjena intravenska infuzija 5-fluorouracila 1000 mg/m2/dan od prvega do četrtega dne.
English: Diarrhoea (G3/4:
Slovenian: Bolezni živčevja disgevzija (S 3/4:
English: G3/4 AST increased G3/4 ALT increased
Slovenian: povišanje ravni AST S povišanje ravni ALT S
English: In a phase III study, 1,218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.
Slovenian: V preskušanju III. faze so 1218 bolnikov z neresektabilnim nedrobnoceličnim pljučnim rakom v stadiju IIIB ali IV, ki so imeli zmogljivost po Karnofskem 70 % ali več in za to bolezen predhodno niso dobivali kemoterapije, naključno razvrstili v tri skupine.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA
English: Myalgia (G3/4: 0.4%)
Slovenian: (S 3/4: 0,4 %)
English: Constipation (G3/4:
Slovenian: povišana telesna temperatura (S 3/4:
English: • blood clots
Slovenian: • krvni strdki;
English: Anaemia (G3/4: 9.4%); Febrile neutropenia; Thrombocytopenia (G4: 0.8%)
Slovenian: Bolezni krvi in limfatičnega sistema anemija (S 3/4: 20,9 %), nevtropenija (S 3/4: 83,2 %), trombocitopenija (S 3/4: 8,8 %), febrilna nevtropenija
English: Anorexia (G3/4: 1.5%)
Slovenian: Presnovne in prehranske motnje anoreksija (S 3/4: 1,5 %)
English: Docetaxel as single agent
Slovenian: Zdravilo Docetaksel Teva kot samostojna učinkovina
English: Alopecia (G3/4: 4.0%).
Slovenian: omotica (S 3/4: 2,0 %),
English: Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija (S 3/4: 2 %), artralgija (S 3/4: 1 %)
English: This vial contains 0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml).
Slovenian: Ta viala vsebuje 0,72 ml raztopine docetaksela 27,73 mg/ml v polisorbatu 80 (polnilni volumen:
English: Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 5.
Slovenian: Bolniki v primerjalnem kraku so prvi dan dobili cisplatin (P) 100 mg/m2 v 30-minutni do 3-urni intravenski infuziji in nato stalno intravensko infuzijo
English: Infection (G3/4: 3.3%)
Slovenian: Infekcijske in parazitske bolezni okužba (S 3/4: 3,3 %)
English: Dysgeusia (G3/4: Peripheral sensory neuropathy (G3/4:
Slovenian: Bolezni živčevja periferna senzorična nevropatija (S 3:
English: • dry mouth
Slovenian: • vnetje požiralnika; • suha usta;
English: • fainting
Slovenian: • omedlevica;
English: Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%); Pain
Slovenian: z 8,5 %); pogostejši so bili tudi hudi kardiotoksični učinki: zastojno srčno popuščanje (3,8 % v prim.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 20 mg/0.72 ml
Slovenian: NALEPKA NA VIALI - VEHIKEL ZA 20 mg/0,72 ml
English: Median TTP (months) (95%CI)
Slovenian: razmerje tveganja (95-odstotni interval zaupanja) *vrednost p srednje PBN (meseci) (95-odstotni interval zaupanja)
English: Further information on Vizimpro can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
Slovenian: Nadaljnje informacije o zdravilu Vizimpro so na voljo na spletni strani agencije: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
English: Vizimpro is available as tablets (15, 30 and 45 mg).
Slovenian: Zdravilo Vizimpro je na voljo v obliki tablet (15, 30 in 45 mg).
English: Before starting treatment, the presence of mutations in the EGFR gene should be confirmed by appropriate tests.
Slovenian: Pred začetkom zdravljenja je treba prisotnost mutacij v genu EGFR potrditi z ustreznimi testi.
English: What measures are being taken to ensure the safe and effective use of Vizimpro?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vizimpro?
English: Vizimpro (dacomitinib)
Slovenian: Vizimpro (dakomitinib)
English: The European Medicines Agency therefore decided that Vizimpro's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Vizimpro večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The patient should normally take a 45-mg tablet once a day, at around the same time every day, for as long as they benefit from it and the side effects are tolerable.
Slovenian: Bolnik mora običajno vzeti 45-miligramsko tableto enkrat na dan, in sicer vsak dan ob približno istem času, dokler mu koristi, neželeni učinki pa so znosni.
English: Other information about Vizimpro
Slovenian: Druge informacije o zdravilu Vizimpro
English: Vizimpro (dacomitinib) EMA/89209/2019
Slovenian: Vizimpro (dakomitinib) EMA/89209/2019
English: As for all medicines, data on the use of Vizimpro are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Vizimpro stalno spremljajo.
English: The most common side effects with Vizimpro (which may affect more than 1 in 5 people) are diarrhoea, rash, stomatitis (inflammation of the lining of the mouth), nail disorder, dry skin, loss of appetite, conjunctivitis (redness and discomfort in the eye), weight and hair loss, itching, elevated levels of transaminases (a sign of liver problems) and nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinki zdravila Vizimpro (ki lahko prizadenejo več kot 1 osebo od 5) so driska, izpuščaj, stomatitis (vnetje ustne sluznice), bolezen nohtov, suha koža, izguba teka, vnetje očesne veznice (pordelost in neugodje v očesu), izguba telesne mase in izpadanje las, srbenje, povišane ravni transaminaze (znak težav z jetri) in navzeja (siljenje na bruhanje).
English: Side effects reported with Vizimpro are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Vizimpro, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Vizimpro is used on its own and only in patients with certain mutations (changes) in the gene for a protein called epidermal growth factor receptor (EGFR).
Slovenian: Zdravilo Vizimpro se uporablja samostojno in samo pri bolnikih z določenimi mutacijami (spremembami) v genu za beljakovino, imenovano receptor za epidermalni rastni dejavnik (EGFR).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vizimpro have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Vizimpro upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What is Vizimpro and what is it used for?
Slovenian: Kaj je zdravilo Vizimpro in za kaj se uporablja?
English: What benefits of Vizimpro have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Vizimpro izkazalo v študijah?
English: What are the risks associated with Vizimpro?
Slovenian: Kakšna tveganja so povezana z zdravilom Vizimpro?
English: Vizimpro can only be obtained with a prescription and treatment must be started and supervised by a doctor with experience in using cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Vizimpro je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: Why is Vizimpro authorised in the EU?
Slovenian: Zakaj je zdravilo Vizimpro odobreno v EU?
English: Although Vizimpro caused more side effects than gefitinib, these were considered manageable.
Slovenian: Čeprav je zdravilo Vizimpro povzročilo več neželenih učinkov kot gefitinib, so bili ti ocenjeni kot obvladljivi.
English: An overview of Vizimpro and why it is authorised in the EU
Slovenian: Pregled zdravila Vizimpro in zakaj je odobreno v EU
English: In lung cancer cells, EGFR is often overactive, causing uncontrolled growth of cancer cells.
Slovenian: V rakavih celicah pljuč je EGFR pogosto čezmerno dejaven in povzroča nenadzorovano rast rakavih celic.
English: By blocking EGFR, dacomitinib helps to reduce the growth and spread of the cancer.
Slovenian: Z zaviranjem EGFR dakomitinib pripomore k manjši rasti in širjenju raka.
English: For more information about using Vizimpro, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Vizimpro glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The most frequent serious side effects are diarrhoea, interstitial lung disease (disorders causing scarring in the lungs), rash and loss of appetite.
Slovenian: Najpogostejši resni neželeni učinki so driska, intersticijska bolezen pljuč (motnje, ki povzročajo brazgotinjenje v pljučih), izpuščaj in izguba teka.
English: The active substance in Vizimpro, dacomitinib, belongs to a group of cancer medicine called tyrosine kinase inhibitor.
Slovenian: Učinkovina v zdravilu Vizimpro, dakomitinib, spada v skupino zdravil za zdravljenje raka, imenovanih zaviralci tirozin-kinaze.
English: Vizimpro is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC) when the disease is advanced or has spread.
Slovenian: Vizimpro je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje odraslih z nedrobnoceličnim pljučnim rakom, kadar je bolezen napredovala ali se je razširila.
English: involving 452 patients with EGFR mutations, patients given Vizimpro lived on average for around 15 months without their disease getting worse, compared with 9 months for those given gefitinib.
Slovenian: V eni glavni študiji, v katero je bilo vključenih 452 bolnikov z mutacijami EGFR, so bolniki, ki so jemali zdravilo Vizimpro, brez poslabšanja bolezni povprečno preživeli 15 mesecev, bolniki, ki so jemali gefitinib, pa devet mesecev.
English: Vizimpro contains the active substance dacomitinib.
Slovenian: Zdravilo Vizimpro vsebuje učinkovino dakomitinib.
English: For the full list of side effects and restrictions of Vizimpro, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Vizimpro glejte navodilo za uporabo.
English: Vizimpro was shown to significantly improve the length of time patients lived without their disease getting worse.
Slovenian: Izkazalo se je, da zdravilo Vizimpro znatno podaljšuje čas, ki ga bolniki preživijo brez poslabšanja bolezni.
English: Patients taking Vizimpro lived for an extra 6 months without their disease getting worse compared with those taking gefitinib.
Slovenian: Bolniki, ki so jemali zdravilo Vizimpro, so brez poslabšanja bolezni živeli šest mesecev več kot bolniki, ki so jemali gefitinib.
English: How is Vizimpro used?
Slovenian: Kako se zdravilo Vizimpro uporablja?
English: Vizimpro has been shown to be more effective than gefitinib (another medicine for non-small cell lung cancer) at prolonging the time patients lived without their disease getting worse.
Slovenian: Zdravilo Vizimpro se je pri podaljšanju časa preživetja bolnikov brez poslabšanja bolezni izkazalo za učinkovitejše od gefitiniba (drugega zdravila za zdravljenje nedrobnoceličnega pljučnega raka).
English: How does Vizimpro work?
Slovenian: Kako zdravilo Vizimpro deluje?
English: The company submitted the results of two main studies.
Slovenian: Družba je predložila rezultate iz dveh glavnih študij.
English: The applicant requested a re-examination of the opinion.
Slovenian: Predlagatelj je zahteval ponovni pregled mnenja.
English: EMA/177547/2013 EMEA/H/C/002429
Slovenian: 21. marec 2013 EMA/275101/2013 EMEA/H/C/002429
English: The company that applied for authorisation is Genzyme Europe B.V.
Slovenian: Vlogo za dovoljenje je predložila družba Genzyme Europe B.V.
English: The effects of Kynamro were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Kynamro so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The CHMP was also concerned by the potential longterm consequences of liver test results showing a build-up of fat in the liver and increased enzyme levels, and was not convinced that the company had proposed sufficient measures to prevent the risk of irreversible liver damage.
Slovenian: Zaskrbljen je bil tudi zaradi morebitnih dolgoročnih posledic rezultatov jetrnih testov, ki so pokazali kopičenje maščob v jetrih in povišanje ravni encimov, poleg tega pa je menil tudi, da družba ni predlagala zadostnih ukrepov za preprečevanje tveganja za trajne okvare jeter.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 21 March 2013.
Slovenian: Po preučitvi podlage za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in 21. marca 2013 potrdil zavrnitev vloge za dovoljenje za promet z zdravilom.
English: This was considered an important limitation because Kynamro is intended for long-term treatment.
Slovenian: Odbor je presodil, da gre za pomembno omejitev, ker je zdravilo Kynamro namenjeno za dolgotrajno zdravljenje.
English: On 13 December 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Kynamro, intended for the treatment of patients with certain forms of familial hypercholesterolaemia.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je 13. decembra 2012 sprejel negativno mnenje in priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Kynamro, namenjenim za zdravljenje bolnikov z nekaterimi oblikami družinske hiperholesterolemije.
English: The main measure of effectiveness was the reduction in the patients' LDL cholesterol levels.
Slovenian: Glavno merilo učinkovitosti je bilo znižanje ravni holesterola LDL pri bolnikih.
English: It was initially expected to be used to treat two closely related forms of the disease called ‘severe heterozygous' and ‘homozygous' familial hypercholesterolaemia.
Slovenian: Prvotno naj bi se uporabljalo za zdravljenje dveh tesno povezanih oblik bolezni, imenovanih „huda heterozigotna‟ in „homozigotna‟ družinska hiperholesterolemija.
English: Therefore, the CHMP refusal was confirmed after re-examination.
Slovenian: Zato je CHMP po ponovnem pregledu potrdil zavrnitev vloge.
English: The company informed the CHMP that patients receiving the medicine in clinical trials will continue to do so as planned.
Slovenian: Družba je CHMP obvestila, da bodo bolniki, ki sodelujejo v kliničnih preskušanjih, še naprej prejemali zdravilo.