natgillin/translations-raw huggingface dataset:
In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels
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
• fever or chills
• povišana telesna temperatura ali mrzlica;
Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Bolezni krvi in limfatičnega sistema nevtropenija (S 3/4: 63 %), anemija (S 3/4: 10 %)
Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija (S 3/4: 0,3 %), mialgija (S 3/4: 0,3 %)
Myalgia
Limfedem
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.
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.
Number of patients Median survival (months) 95% CI
(95-odstotni interval zaupanja) srednji čas preživetja (meseci) (95-odstotni interval zaupanja)
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
Lacrimation increased; Conjunctivitis
Očesne bolezni močnejše solzenje, konjunktivitis
Constipation (G3/4: 0.4%)
zaprtost (S 3/4: 0,4 %)
Fatigue/ weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
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 %)
Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion docetaxel
Docetaksel Teva 80 mg/2,88 ml koncentrat in vehikel za raztopino za infundiranje docetaksel
Neutropenia (G3/4: 83.5%); Anaemia (G3/4: 12.4%); Thrombocytopenia (G3/4: 4.0%);
Bolezni krvi in limfatičnega sistema nevtropenija (S 3/4: anemija (S 3/4: 12,4 %), trombocitopenija (S 3/4:
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%).
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
Peripheral sensory neuropathy (G3/4: 8.7%)
Bolezni živčevja periferna senzorična nevropatija (S 3: 3,7 %),
• 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
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.
Diarrhoea (G3/4:
Bolezni živčevja disgevzija (S 3/4:
G3/4 AST increased G3/4 ALT increased
povišanje ravni AST S povišanje ravni ALT S
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.
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.
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Myalgia (G3/4: 0.4%)
(S 3/4: 0,4 %)
Constipation (G3/4:
povišana telesna temperatura (S 3/4:
• blood clots
• krvni strdki;
Anaemia (G3/4: 9.4%); Febrile neutropenia; Thrombocytopenia (G4: 0.8%)
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
Anorexia (G3/4: 1.5%)
Presnovne in prehranske motnje anoreksija (S 3/4: 1,5 %)
Docetaxel as single agent
Zdravilo Docetaksel Teva kot samostojna učinkovina
Alopecia (G3/4: 4.0%).
omotica (S 3/4: 2,0 %),
Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija (S 3/4: 2 %), artralgija (S 3/4: 1 %)
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).
Ta viala vsebuje 0,72 ml raztopine docetaksela 27,73 mg/ml v polisorbatu 80 (polnilni volumen:
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.
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
Infection (G3/4: 3.3%)
Infekcijske in parazitske bolezni okužba (S 3/4: 3,3 %)
Dysgeusia (G3/4: Peripheral sensory neuropathy (G3/4:
Bolezni živčevja periferna senzorična nevropatija (S 3:
• dry mouth
• vnetje požiralnika; • suha usta;
• fainting
• omedlevica;
Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%); Pain
z 8,5 %); pogostejši so bili tudi hudi kardiotoksični učinki: zastojno srčno popuščanje (3,8 % v prim.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 20 mg/0.72 ml
NALEPKA NA VIALI - VEHIKEL ZA 20 mg/0,72 ml
Median TTP (months) (95%CI)
razmerje tveganja (95-odstotni interval zaupanja) *vrednost p srednje PBN (meseci) (95-odstotni interval zaupanja)
Further information on Vizimpro can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
Nadaljnje informacije o zdravilu Vizimpro so na voljo na spletni strani agencije: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
Vizimpro is available as tablets (15, 30 and 45 mg).
Zdravilo Vizimpro je na voljo v obliki tablet (15, 30 in 45 mg).
Before starting treatment, the presence of mutations in the EGFR gene should be confirmed by appropriate tests.
Pred začetkom zdravljenja je treba prisotnost mutacij v genu EGFR potrditi z ustreznimi testi.
What measures are being taken to ensure the safe and effective use of Vizimpro?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vizimpro?
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.
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.
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.
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.
Other information about Vizimpro
Druge informacije o zdravilu Vizimpro
As for all medicines, data on the use of Vizimpro are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Vizimpro stalno spremljajo.
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).
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).
Side effects reported with Vizimpro are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Vizimpro, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
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).
Zdravilo Vizimpro se uporablja samostojno in samo pri bolnikih z določenimi mutacijami (spremembami) v genu za beljakovino, imenovano receptor za epidermalni rastni dejavnik (EGFR).
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.
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.
What is Vizimpro and what is it used for?
Kaj je zdravilo Vizimpro in za kaj se uporablja?
What benefits of Vizimpro have been shown in studies?
Kakšne koristi je zdravilo Vizimpro izkazalo v študijah?
What are the risks associated with Vizimpro?
Kakšna tveganja so povezana z zdravilom Vizimpro?
Vizimpro can only be obtained with a prescription and treatment must be started and supervised by a doctor with experience in using cancer medicines.
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.
Why is Vizimpro authorised in the EU?
Zakaj je zdravilo Vizimpro odobreno v EU?
Although Vizimpro caused more side effects than gefitinib, these were considered manageable.
Čeprav je zdravilo Vizimpro povzročilo več neželenih učinkov kot gefitinib, so bili ti ocenjeni kot obvladljivi.
An overview of Vizimpro and why it is authorised in the EU
Pregled zdravila Vizimpro in zakaj je odobreno v EU
In lung cancer cells, EGFR is often overactive, causing uncontrolled growth of cancer cells.
V rakavih celicah pljuč je EGFR pogosto čezmerno dejaven in povzroča nenadzorovano rast rakavih celic.
By blocking EGFR, dacomitinib helps to reduce the growth and spread of the cancer.
Z zaviranjem EGFR dakomitinib pripomore k manjši rasti in širjenju raka.
For more information about using Vizimpro, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Vizimpro glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The most frequent serious side effects are diarrhoea, interstitial lung disease (disorders causing scarring in the lungs), rash and loss of appetite.
Najpogostejši resni neželeni učinki so driska, intersticijska bolezen pljuč (motnje, ki povzročajo brazgotinjenje v pljučih), izpuščaj in izguba teka.
The active substance in Vizimpro, dacomitinib, belongs to a group of cancer medicine called tyrosine kinase inhibitor.
Učinkovina v zdravilu Vizimpro, dakomitinib, spada v skupino zdravil za zdravljenje raka, imenovanih zaviralci tirozin-kinaze.
Vizimpro is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC) when the disease is advanced or has spread.
Vizimpro je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje odraslih z nedrobnoceličnim pljučnim rakom, kadar je bolezen napredovala ali se je razširila.
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.
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.
Vizimpro contains the active substance dacomitinib.
Zdravilo Vizimpro vsebuje učinkovino dakomitinib.
For the full list of side effects and restrictions of Vizimpro, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Vizimpro glejte navodilo za uporabo.
Vizimpro was shown to significantly improve the length of time patients lived without their disease getting worse.
Izkazalo se je, da zdravilo Vizimpro znatno podaljšuje čas, ki ga bolniki preživijo brez poslabšanja bolezni.
Patients taking Vizimpro lived for an extra 6 months without their disease getting worse compared with those taking gefitinib.
Bolniki, ki so jemali zdravilo Vizimpro, so brez poslabšanja bolezni živeli šest mesecev več kot bolniki, ki so jemali gefitinib.
How is Vizimpro used?
Kako se zdravilo Vizimpro uporablja?
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.
Zdravilo Vizimpro se je pri podaljšanju časa preživetja bolnikov brez poslabšanja bolezni izkazalo za učinkovitejše od gefitiniba (drugega zdravila za zdravljenje nedrobnoceličnega pljučnega raka).
How does Vizimpro work?
Kako zdravilo Vizimpro deluje?
The company submitted the results of two main studies.
Družba je predložila rezultate iz dveh glavnih študij.
The applicant requested a re-examination of the opinion.
Predlagatelj je zahteval ponovni pregled mnenja.
EMA/177547/2013 EMEA/H/C/002429
21. marec 2013 EMA/275101/2013 EMEA/H/C/002429
The company that applied for authorisation is Genzyme Europe B.V.
Vlogo za dovoljenje je predložila družba Genzyme Europe B.V.
The effects of Kynamro were first tested in experimental models before being studied in humans.
Učinki zdravila Kynamro so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
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.
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.
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.
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.
This was considered an important limitation because Kynamro is intended for long-term treatment.
Odbor je presodil, da gre za pomembno omejitev, ker je zdravilo Kynamro namenjeno za dolgotrajno zdravljenje.
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.
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.
The main measure of effectiveness was the reduction in the patients' LDL cholesterol levels.
Glavno merilo učinkovitosti je bilo znižanje ravni holesterola LDL pri bolnikih.
It was initially expected to be used to treat two closely related forms of the disease called ‘severe heterozygous' and ‘homozygous' familial hypercholesterolaemia.
Prvotno naj bi se uporabljalo za zdravljenje dveh tesno povezanih oblik bolezni, imenovanih „huda heterozigotna‟ in „homozigotna‟ družinska hiperholesterolemija.
Therefore, the CHMP refusal was confirmed after re-examination.
Zato je CHMP po ponovnem pregledu potrdil zavrnitev vloge.
The company informed the CHMP that patients receiving the medicine in clinical trials will continue to do so as planned.
Družba je CHMP obvestila, da bodo bolniki, ki sodelujejo v kliničnih preskušanjih, še naprej prejemali zdravilo.
One involved 51 patients with homozygous familial hypercholesterolaemia and the other involved 58 patients with severe heterozygous familial hypercholesterolaemia.
V prvo je bilo vključenih 51 bolnikov s homozigotno družinsko hiperholesterolemijo, v drugo pa 58 bolnikov s hudo heterozigotno družinsko hiperholesterolemijo.
What is Kynamro?
Kaj je zdravilo Kynamro?
Moreover, the Committee was concerned that more cardiovascular events (problems with the heart and blood vessels) were reported in patients taking Kynamro than in patients taking placebo.
Prav tako je bil zaskrbljen zaradi dejstva, da je o kardiovaskularnih dogodkih (težavah s srcem in krvnimi žilami) poročalo več bolnikov, ki so prejemali zdravilo Kynamro, kot bolnikov, ki so prejemali placebo.
Refusal of the marketing authorisation for Kynamro (mipomersen)
Zavrnitev vloge za dovoljenje za promet z zdravilom Kynamro (mipomersen)
Kynamro is a medicine that contains the active substance mipomersen.
Kynamro je zdravilo, ki vsebuje zdravilno učinkovino mipomersen.
Patients with homozygous familial hypercholesterolaemia have high blood levels of these types of cholesterol, which increases the risk of coronary heart disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle).
Bolniki s homozigotno družinsko hiperholesterolemijo imajo visoke ravni omenjenih vrst holesterola v krvi, ki povečujejo tveganje za koronarno bolezen srca (bolezen srca, ki jo povzroči zapora krvnih žil, ki oskrbujejo srčno mišico).
During the re-examination in March 2013, the CHMP's concerns remained unresolved and were not fully addressed by measures proposed by the company.
Med ponovnim pregledom marca 2013 so pomisleki, ki jih je izrazil CHMP, ostali enaki, poleg tega pa družba ni predlagala zadovoljivih ukrepov, ki bi jih pomagali odpraviti.
Refusal of the marketing authorisation for Kynamro (mipomersen) EMA/177547/2013
Zavrnitev vloge za dovoljenje za promet z zdravilom Kynamro (mipomersen) EMA/275101/2013
Patients applying for compassionate use programmes will continue to be evaluated and will receive the medicine if eligible.
Bolnike, ki se bodo prijavili v programe sočutne uporabe zdravila, bo družba še naprej ocenjevala in jim v primeru ustreznosti predpisala zdravilo.
During the assessment of Kynamro, the indication was restricted to the most severely affected patients with homozygous and compound heterozygous familial hypercholesterolaemia only.
Med ocenjevanjem zdravila Kynamro so indikacijo omejili samo na najhuje prizadete bolnike s homozigotno in sestavljeno heterozigotno družinsko hiperholesterolemijo.
What was Kynamro expected to be used for?
Za kaj naj bi se zdravilo Kynamro uporabljalo?
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Kynamro did not outweigh its risks and recommended that it be refused marketing authorisation.
Posledično je tedaj menil, da koristi zdravila Kynamro ne odtehtajo z njim povezanih tveganj, zato je priporočil zavrnitev dovoljenja za promet z zdravilom.
By blocking the production of apolipoprotein B, Kynamro was expected to reduce the levels of these types of lipoproteins in the blood of patients.
Zdravilo Kynamro naj bi z zaviranjem tvorjenja apolipoproteina B pomagalo zmanjšati ravni teh vrst lipoproteinov v krvi bolnikov.
It was expected to be used together with other cholesterol-lowering medicines and a low-fat diet.
Zdravilo naj bi se uporabljalo skupaj z drugimi zdravili za zniževanje ravni holesterola in dieto z malo maščobami.
Kynamro was expected to be used to treat patients with an inherited disease causing high blood cholesterol levels, called familial hypercholesterolaemia.
Zdravilo Kynamro naj bi se uporabljalo za zdravljenje bolnikov z dedno boleznijo, ki povzroča visoke ravni holesterola v krvi, imenovano družinska hiperholesterolemija.
In December 2012, the CHMP was concerned that a high proportion of patients stopped taking the medicine within two years, even in the restricted group of patients with homozygous familial hypercholesterolaemia, mainly due to side effects.
Decembra 2012 je CHMP izrazil zadržke zaradi visokega deleža bolnikov, tudi v omejeni skupini bolnikov s homozigotno družinsko hiperholesterolemijo, ki so predvsem zaradi neželenih učinkov v dveh letih prenehali uporabljati zdravilo.
This prevented the CHMP from concluding that Kynamro's intended cardiovascular benefit, in terms of reducing cholesterol levels, outweighed its potential cardiovascular risk.
Zato ni mogel zaključiti, da predvidene koristi zdravila Kynamro pri zniževanju ravni holesterola odtehtajo z njim povezana možna kardiovaskularna tveganja.
The studies compared the effects of Kynamro with placebo when added onto treatment with other cholesterol-lowering medicines and a low-fat diet, for a treatment period of 26 weeks.
V študijah so učinke zdravila Kynamro ob uporabi z drugimi zdravili za zniževanje holesterola in dieti z malo maščobami primerjali s placebom v 26-tedenskem obdobju zdravljenja.
The active substance in Kynamro, mipomersen, is an ‘antisense oligonucleotide', a very short fragment of DNA designed to block the production of a protein called apolipoprotein B, by attaching to the genetic material of cells responsible for producing it. Apolipoprotein B is the main component of ‘low density lipoprotein' (LDL) cholesterol, commonly known as ‘bad cholesterol', and of two closely related types of cholesterol called ‘intermediate density lipoprotein' (IDL) and ‘very low density lipoprotein' (VLDL) cholesterol.
Apolipoprotein B je glavna sestavina holesterola v „lipoproteinih majhne gostote‟ (LDL), ki je splošno znan kot „slabi holesterol‟, in dveh tesno povezanih vrstah holesterola, imenovanih holesterol v „lipoproteinih srednje gostote‟ (IDL) in holesterol v „lipoproteinih zelo majhne gostote‟ (VLDL).
How is Kynamro expected to work?
Kako naj bi zdravilo Kynamro delovalo?
Invented
Ovojnina
• At the request of the European Medicines Agency.
na zahtevo Evropske agencije za zdravila.
Date of first authorisation: 29 November 2010 Date of latest renewal: 19 June 2015
Datum prve pridobitve dovoljenja za promet: 29. november 2010 Datum zadnjega podaljšanja: 19. junija 2015
In addition, an updated RMP should be submitted:
Poleg tega je treba posodobljeni RMP vložiti,
(see section 4.2).
(glejte poglavje 4.4)
3°years
3 leta
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernico CHMP o sistemih upravljanja s tveganji za zdravila za uporabo v humani medicini je treba posodobljeni RMP predložiti hkrati z naslednjim rednim dopolnjenim poročilom o varnosti zdravila (PSUR).