natgillin/translations-raw huggingface dataset:
The most common side effects with Vantavo include abdominal pain (stomach ache), dyspepsia (heartburn), oesophageal (gullet) ulcers, dysphagia (difficulty swallowing), abdominal distension (swollen tummy) and acid regurgitation.
Najpogostejši neželeni učinki zdravila Vantavo so bolečine v trebuhu, dispepsija (zgaga), razjede požiralnika, disfagija (težave pri požiranju), napihnjen trebuh in refluks kisline.
This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Vantavo 70 mg/2,800 IU on its own or adding 2,800 IU vitamin D3 (equivalent to using Vantavo 70 mg/5,600 IU).
Ta študija je bila pri 652 bolnikih podaljšana za nadaljnjih 24 tednov, da bi učinke nadaljevanja zdravljenja samo z zdravilom Vantavo 70 mg/2800 i.e. primerjali z učinki dodajanja 2800 i.e. vitamina D3 (kar je enakovredno uporabi zdravila Vantavo 70 mg/5600 i.e.).
To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Vantavo's ability to increase vitamin D levels.
V podporo uporabi kombinacije alendronske kisline in vitamina D3 v isti tableti in za pridobitev dokazov, da zdravilo Vantavo lahko poveča ravni vitamina D, je družba izvedla študijo s 717 bolniki z osteoporozo, ki je vključevala 682 žensk, pri katerih se je že pojavila menopavza.
Vantavo is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Vantavo je zdravilo, ki vsebuje dve zdravilni učinkovini: alendronsko kislino in holekalciferol (vitamin D3).
In the extension study, similar numbers of patients taking Vantavo 70 mg/2,800 IU and Vantavo 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Vantavo 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.
V podaljšani študiji je bilo število bolnic z nizkimi ravnmi vitamina D (pod 6 %) v skupini, ki je jemala zdravilo Vantavo 70 mg/2 800 i.e. podobno številu bolnic v skupini, ki je prejemala zdravilo Vantavo 70 mg/5 600 i.e., vendar pa so se pri tistih, ki so jemale zdravilo Vantavo 70 mg/5 600 i.e., v 24 tednih študije ravni vitamina D bolj povečale.
Patients should also take calcium supplements if they are not getting enough calcium from their diet. For more information, see the package leaflet.
Bolnice morajo jemati tudi dodatke kalcija, če njegov vnos s prehrano ni zadosten.
Patients received either Vantavo 70 mg/2,800 IU or alendronic acid only once a week.
Bolnice so enkrat tedensko prejemale bodisi zdravilo Vantavo 70 mg/2 800 i.e. bodisi le alendronsko kislino.
What is Vantavo used for?
Za kaj se zdravilo Vantavo uporablja?
How has Vantavo been studied?
Kako je bilo zdravilo Vantavo raziskano?
Vantavo (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels.
Zdravilo Vantavo (ki vsebuje 2 800 ali 5 600 i.e. holekalciferola) se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, pri katerih obstaja tveganje za pomanjkanje vitamina D. Zdravilo Vantavo 70 mg/5 600 i.e. se uporablja pri bolnikih, ki ne jemljejo dodatkov vitamina D. Zdravilo zmanjšuje tveganje za zlome kosti v hrbtenici in kolkih.
Vantavo contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Zdravilo Vantavo vsebuje dve zdravilni učinkovini: alendronsko kislino in holekalciferol (vitamin D3).
Vantavo alendronic acid and colecalciferol
Vantavo alendronska kislina in holekalciferol
How is Vantavo used?
Kako se zdravilo Vantavo uporablja?
What is Vantavo?
Kaj je zdravilo Vantavo?
How does Vantavo work?
Kako zdravilo Vantavo deluje?
After 15 weeks, fewer patients had low vitamin D levels when they took Vantavo 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%).
Dodatne študije so pokazale, da lahko vključitev vitamina D3 in alendronske kisline v isto tableto poveča ravni vitamina D. Po 15 tednih zdravljenja je bil delež bolnic z nizko ravnjo vitamina D med bolniki, zdravljenih z zdravilom Vantavo 70 mg/2 800 i.e., nižji (11 %) kot pri tistih, ki so prejemale le alendronsko kislino (32 %).
Strength Pharmaceutical
Jakost Farmacevtska
EU Number Invented
EU številka
Packaging
Ciljna
9 July 2001
9. julij 2001
See the Module ”All authorised presentations”
Glej modul »All authorised presentations«
Levviax is indicated for the treatment of the following infections:
Levviax je indiciran za zdravljenje naslednjih okužb:
Date of issue of Marketing Authorisation valid throughout the European Union:
Datum izdaje dovoljenja za promet z zdravilom, veljavnega po vsej Evropski uniji:
For detailed conditions for the use of this product, scientific information or procedural aspects please refer to the relevant modules.
Podrobnosti o pogojih uporabe tega zdravila, informacijah znanstvene narave ter postopkovnih vidikih najdete v ustreznih modulih.
Pharmaco-therapeutic group (ATC Code):
Farmakološko-terapevtska skupina (ATC klasifikacija):
LEVVIAX International Nonproprietary Name (INN): Telithromycin Abstract
Mednarodno nelastniško ime (INN): telitromicin
Currently approved therapeutic indication(s):
Trenutno odobrena(e) terapevtska(e) indikacija(e):
EMEA/H/C/0355 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EUROPEAN PUBLIC ASSESSMENT REPORT - EPAR)
When prescribing Levviax, consideration should be given to official guidance on the appropriate use of antibacterial agents.
Pri predpisovanju zdravila Levviax je potrebno upoštevati uradne smernice za ustrezno uporabo protibakterijskih zdravil.
The initial approval was based on studies, which showed that the potential benefits with telithromycin particularly relate to its use in the treatment of infections caused by penicillin and/or erythromycin resistant S. pneumoniae.
Prvotna odobritev zdravila je temeljila na rezultatih študij, ki so pokazale, da so potencialne prednosti telitromicina povezane zlasti z njegovo uporabo pri zdravljenju okužb, povzročenih s S. pneumoniae, odpornimi proti penicilinu in/ali eritromicinu.
Telithromycin interacts with the translation at the 23S ribosomal RNA level and some data also indicate that assembly of the 30S subunit may be impaired.
Telitromicin ovira ribosomsko translacijo na ravni 23S ribosomske RNA, določeni podatki pa kažejo tudi na to, da zmore zavreti nastanek podenote 30S.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers that the benefit risk ratio for Levviax is favourable in the approved indication
Na podlagi predloženih podatkov o kakovosti, varnosti in učinkovitosti zdravila CHMP meni, da je zdravilo Levviax izkazalo ugodno razmerje med tveganji in koristmi za odobreno indikacijo.
Orphan medicinal product designation date:
Datum določitve zdravila kot zdravila sirote:
The most common side effects are, as for macrolides, mainly reported from the digestive and nervous systems, with diarrhoea, nausea, headache and dizziness.
Najpogostejši stranski učinki so, tako kot pri makrolidih, povezani s prebavnim traktom in živčnim sistemom ter vključujejo drisko, navzeo, glavobol in vrtoglavico.
However, clinical experience is still rather limited in the treatment of these infections, and therefore telithromycin should be used with caution until further experience of emergence of resistance has been gained, especially in areas with a high prevalence of resistant pneumococci.
Toda klinične izkušnje s telitromicinom za zdravljenje teh okužb so še vedno skromne, zato je potrebno telitromicin uporabljati previdno dokler ne pridobimo nadaljnjih izkušenj v povezavi z odpornostjo bakterij, zlasti na področjih z visoko prevalenco odpornih pnevmokokov.
The active substance of Levviax is telithromycin, an antibacterial medicinal product which is a novel semi-synthetic antibacterial agent belonging to a new family of antibiotics, the ketolides, closely related to the well-known macrolide antibiotics.
Učinkovina zdravila Levviax je telitromicin, novo, protibakterijsko zdravilo, ki je dejansko novo polsintetično protibakterijsko zdravilo in spada v novo družino antibiotikov, imenovanih ketolidi, ki so tesno povezani z znanimi makrolidnimi antibiotiki.
Aventis Pharma S.A. 20 avenue Raymond Aron F-92160 Antony France
Imetnik dovoljenja za promet z zdravilom: Aventis Pharma S.A. 20 avenue Raymond Aron
Not applicable
Navedba smiselno ni potrebna
Adverse events assessed as possibly related to study treatment were reported for 35.8% of the telithromycin patients, versus 28.3% of the comparators.
Pri 35,8 % bolnikov, ki so bili zdravljeni s telitromicinom, so poročali o stranskih učinkih, ki bi bili lahko povezani z uporabo telitromicina, medtem ko je ta odstotek pri zdravljenju s primerljivimi učinkovinami znašal 28,3 %.
The frequency and severity of increased hepatic enzyme activity and liver disease appear similar to clarithromycin but justify close post-marketing surveillance, as does the potential prolongation of the QT-interval
Pogostost in resnost povečane aktivnosti jetrnih encimov ter bolezni jeter se zdita podobna kot pri klaritromicinu, toda navkljub temu je potrebno skrbno postmarketinško spremljanje teh stranskih učinkov kot tudi drugega možnega stranskega učinka, podaljšanja intervala QT.
Clinical trials, in general, support similar efficacy of telithromycin and comparators in the indications investigated (CAP not clinically serious enough to warrant parenteral therapy but efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years, AECB, sinusitis, and pharyngotonsillitis caused by S. pyogenes).
Klinične raziskave v splošnem potrjujejo podobno učinkovitost telitromicina in primerjalnih učinkovin za raziskane indikacije (pljučnica, pridobljena v domačem okolju, ki glede na resnost kliničnega stanje ne potrebuje parenteralnega zdravljenja; po drugi strani pa se je telitromicin izkazal kot učinkovit pri določenem številu bolnikov s pljučnico, pridobljeno v domačem okolju, in dejavniki tveganja kot sta pnevmokokna bakteriemija ali starost nad 65 let).
In patients of 18 years and older: - Community-acquired pneumonia, mild or moderate, - Acute exacerbation of chronic bronchitis, - Acute sinusitis, - Tonsillitis/pharyngitis caused by Group A beta streptococci, as an alternative when beta lactam antibiotics are not appropriate.
Pri bolnikih, starejših od 18 let: - plučnica, dobljena v domačem okolju, blaga ali zmerna, - akutno poslabšanje kroničnega bronhitisa, - akutni sinuzitis, - tonzilitis/faringitis, ki ga povzročajo beta streptokoki skupine A, kot alternativno zdravilo,
Antibacterial for systemic use JO1
Zdravila za sistemsko zdravljenje bakterijskih infekcij
Tonsillitis/pharyngitis caused by Group A beta streptococci, as an alternative when beta lactam antibiotics are not appropriate
Pri bolnikih, starih od 12 do 18 let: tonzilitis/faringitis, ki ga povzročajo beta-streptokoki skupine A, kot alternativno zdravilo, kadar betalaktamski antibiotiki niso primerni.
The pharmacological action of telithromycin involves inhibition of bacterial protein synthesis and is similar to that of macrolides, but
Farmakološko delovanje telitromicina temelji na zaviranju sinteze proteinov v bakterijah in je podobno delovanju makrolidov, vendarle naj bi med skupinama na molekularnem nivoju obstajale razlike v delovanju.
Authorised presentations:
Odobrene farmacevtske oblike:
London, 15 November 2007 Doc.
London, 15. november 2007 Sklic dok.
This could have had an impact on the types of treatment chosen by doctors if they had relied on the test's results.
To bi lahko imelo vpliv na tip zdravljenja, ki bi ga izbrali zdravniki, če bi se zanašali na rezultat testa.
These included healthy volunteers and patients with stomach problems.
Študiji sta vključevali zdrave prostovoljce in bolnike z želodčnimi težavami.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v klinično preskušanje ali program sočutne uporabe ter potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
The letter from the company notifying the EMEA of the withdrawal of the application is available here
Dopis podjetja, s katerim je bila EMEA obveščena o umiku vloge, je na voljo tukaj.
This labelled carbon dioxide can be detected in breath samples taken every 15 to 30 minutes in the four hours after the test meal.
Tak označen ogljikov dioksid lahko nato zaznavamo v vzorcih izdihanega zraka, ki jih vzamemo vsakih 15 do 30 minut v štirih urah po testnem obroku.
In both studies, the main measure of effectiveness was how long it took for half of the stomach's solid contents to be emptied.
Glavno merilo učinkovitosti je bil v obeh študijah čas, ki je bil potreben za izpraznitev polovice trdne vsebine želodca.
International non-proprietary name (INN): 1-13C-caprylic acid
Mednarodno nelastniško ime (INN): 1-13C-kaprilna kislina
Gastromotal is a diagnostic test.
Zdravilo Gastromotal je diagnostični test.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for GASTROMOTAL
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo GASTROMOTAL
This means that it contains 13C, a non-radioactive, rare form of the carbon atom, instead of carbon-12 (12C), the form that is the most common in nature.
To pomeni, da vsebuje ogljik 13C, neradioaktivno, redko obliko ogljikovih atomov, namesto v naravi najpogosteje prisotnega ogljika-12 (12C).
The rate of stomach emptying can then be determined by looking at the speed at which labelled carbon dioxide is released in the breath.
Hitrost praznjenja želodca je nato mogoče določiti z ugotavljanjem hitrosti sproščanja označenega ogljikovega dioksida v izdihanem zraku.
In the main studies, the level of agreement between Gastromotal and the standard test was too low to be acceptable, resulting in a considerable risk of false positive and false negative results.
Raven skladnosti med zdravilom Gastromotal in standardnim testom je bila v glavnih študijah prenizka, da bi bilo zdravilo sprejemljivo, saj bi povzročilo znatno tveganje za napačne pozitivne ali negativne rezultate.
When a patient takes a dose of Gastromotal mixed into a test meal, it enters the stomach with the food.
Če bolnik vzame odmerek zdravila Gastromotal, vmešanega v testni obrok, zdravilo vstopi v želodec skupaj s hrano.
On 5 November 2007, INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Gastromotal, for in vivo diagnosis of solidphase gastric half emptying time in gastric motility disorders.
Podjetje INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH je 5. novembra 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za dovoljenje za promet z zdravilom Gastromotal, namenjeno za in vivo diagnozo časa praznjenja polovice vsebine želodca v trdni fazi pri motnjah z gibanjem želodca.
The effects of Gastromotal were first tested in experimental models before being studied in humans.
Učinki zdravila Gastromotal so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Gastromotal?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih/programih sočutne uporabe zdravila Gastromotal?
As the food in the stomach is gradually emptied into the gut, it takes the Gastromotal with it, where it is absorbed into the blood and then broken down, releasing carbon dioxide gas labelled with 13C into the breath.
Ko hrana v želodcu počasi prehaja v črevo, s seboj prenese tudi zdravilo Gastromotal, ki se tam vsrka v kri in nato razgradi, pri tem pa sprošča ogljikov dioksid, označen z ogljikom 13C, v izdihan zrak.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Gastromotal had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Zato je bil v času umika CHMP mnenja, da koristi zdravila Gastromotal niso zadostno dokazane in da morebitne koristi niso večje od znanih tveganj.
The active substance in Gastromotal, 1-13C-caprylic acid, is a natural chemical called caprylic acid that has been labelled with carbon-13 (13C).
Zdravilna učinkovina v zdravilu Gastromotal, 1-13C-kaprilna kislina, je naravna kemikalija, imenovana kaprilna kislina, ki je označena z ogljikom-13 (13C).
It was to be available as a syringe containing a liquid for drinking, containing the active substance 1-13C-caprylic acid (90 mg).
Zdravilo naj bi bilo na voljo v obliki injekcijske brizge, ki vsebuje pitno tekočino z zdravilno učinkovino 1-13C-kaprilno kislino (90 mg).
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Gastromotal.
Podjetje je CHMP obvestilo, da za bolnike, ki so trenutno vključeni v klinična preizkušanja ali sočutno uporabo zdravila Gastromotal, ni nobenih posledic.
Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Gastromotal could not have been approved for the diagnosis of delayed stomach emptying.
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo Gastromotal ni mogoče odobriti dovoljenja za diagnozo upočasnjenega praznjenja želodca.
Gastromotal was expected to be used to diagnose delayed stomach emptying in patients with stomach problems.
Zdravilo Gastromotal naj bi se uporabljalo za diagnozo upočasnjenega praznjenja želodca pri bolnikih z želodčnimi težavami.
The CHMP was concerned that the reliability and usefulness of Gastromotal in diagnosing delayed stomach empting had not been shown.
CHMP je izrazil zadržke, ker zanesljivost in uporabnost zdravila Gastromotal pri diagnostiki upočasnjenega praznjenja želodca nista bili dokazani.
What is Gastromotal?
Kaj je zdravilo Gastromotal?
What was Gastromotal expected to be used for?
Za kaj naj bi se zdravilo Gastromotal uporabljalo?
The effectiveness of Gastromotal has been compared with that of a standard test called 99Tc-scintigraphy (a type of scan using radioactive tracers) in two main studies involving a total of 310
Učinkovitost zdravila Gastromotal so primerjali s standardnim testom, imenovanim 99Tc-scintigrafija
The CHMP was assessing the responses given by the company to a list of questions.
Podjetje je umaknilo vlogo na 200. dan. CHMP je ocenil odgovore podjetja na seznam vprašanj.
How is Gastromotal expected to work?
Kako naj bi zdravilo Gastromotal delovalo?
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe, imetnikov dovoljenja za promet z zdravilom v državah članicah
D-85540 Haar
D-85540 Haar Nemčija
Šmartinska cesta 140, 1000 Ljubljana, Slovenia
Šmartinska cesta 140, 1000 Ljubljana, Slovenija
Powder for suspension for parenteral use (IM)
prašek za suspenzijo za parenterlano uporabo (i.m.)
Bucureşti-Ploieşti Nr.1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti
Bucureşti-Ploieşti Nr.1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti, Romuija
18th Km Athens-Lamia National Road 14671 Nea Erythrea Greece
18th Km Athens-Lamia National Road 14671 Nea Erythrea Grčija
C/ Josefa Valcárcel, 38 28027 Madrid Spain
C/ Josefa Valcárcel, 38 28027 Madrid Španija
Via Vitorchiano, 151 - 00189 Roma
Via Vitorchiano, 15100189 Roma Italija
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Združeno kraljestvo Velike Britanije in Severne Irske
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Herts, EN11 9BU United Kingdom
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Herts, EN11 9BU, Združeno kraljestvo Velike Britanije in Severne Irske
Dry Powder for injection
suhi prašek za injekcije intravenska uporaba
Merck Sharp & Dohme, UAB, Kęstučio 59/27, LT-08124 Vilnius
Kęstučio 59/27, LT-08124 Vilnius,
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A, Viale Shakespeare, 47 00144 Roma
Viale Shakespeare, 47 00144 Roma Italija
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, P.O.Box 581, 2003 PC Haarlem
Waarderweg 39, 2031 BN Haarlem, P.O.Box 581, 2003 PC Haarlem Nizozemska
Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem, P.O.Box 581, 2003 PC Haarlem The Netherlands
Waarderweg 39, Haarlem, P.O.Box 581, 2003 PC Haarlem Nizozemska
250 mg/250 mg Powder for infusion
250 mg/250 mg prašek za infundiranje intravenska uporaba
500 mg powder for solution for infusion 500 mg/500 mg Powder for solution for infusion Intravenous use
500 mg powder for solution for infusion 500 mg/500 mg prašek za raztopino za infundiranje
ZIENAM° 500 mg Pulver zur Herstellung einer Infusionslösung
ZIENAM° 500 mg Pulver zur Herstellung einer Infusionslösung intravenska iuporaba
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, The Netherlands
Waarderweg 39, 2031 BN Haarlem, Nizozemska
500 mg/500 mg
250 mg in 500 mg
PrimaxinIV 500mg Injection 500mg
PrimaxinIV 500mg Injection 500mg prašek za koncentrat za raztopino za infundiranje
Primaxin IV 500mg Injection 500mg
Primaxin IV 500mg Injection 500mg prašek za koncentrat za raztopino za infundiranje
500 mg/500 mg Powder for infusion
500 MG/500 MG 500 mg/500 mg prašek za raztopino za infundiranje
500 mg + 500 mg Powder for solution for injection Intravenous use
500 mg/500 mg prašek za infundiranje intravenska uporaba
Further information on Keytruda can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/keytruda.
Nadaljnje informacije za zdravilo Keytruda so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/keytruda.
The European Medicines Agency decided that Keytruda's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Keytruda večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Keytruda received a marketing authorisation valid throughout the EU on 17 July 2015.
Za zdravilo Keytruda je bilo 17. julija 2015 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Keytruda?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Keytruda?
In addition, the company will provide the final results of studies with Keytruda to confirm the longterm benefits of the medicine.
Poleg tega bo predložilo tudi končne rezultate študij o zdravilu Keytruda, ki naj bi potrdili dolgoročne koristi tega zdravila.
Moreover, the company will carry out analyses to better understand which patients are likely to benefit most from treatment with Keytruda.
Prav tako bo opravilo analize, da bi bolje razumeli, kateri bolniki bi lahko imeli največ koristi od zdravljenja z zdravilom Keytruda.
When it is given with other cancer medicines, the dose is always 200 mg every three weeks.
Kadar se daje v kombinaciji z drugimi zdravili za zdravljenje raka, znaša odmerek vedno 200 mg vsake tri tedne.
The medicine can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in the treatment of cancer.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem rakavih obolenj.
Why is Keytruda authorised in the EU?
Zakaj je bilo zdravilo Keytruda odobreno v EU?