natgillin/translations-raw huggingface dataset:
At least 72 hours must pass between two consecutive doses of Velcade.
Med dvema zaporednima odmerkoma zdravila Velcade mora miniti vsaj 72 ur.
Why has Velcade been approved?
Zakaj je bilo zdravilo Velcade odobreno?
For the full list of all side effects reported with Velcade, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Velcade, glejte navodilo za uporabo.
Velcade 1 mg must only be given by injection into a vein, while Velcade 3.5 mg is only given either by injection into a vein or under the skin.
Zdravilo Velcade v odmerku 1 mg se daje z injekcijo v veno, medtem ko se zdravilo Velcade v odmerku 3,5 mg daje z injiciranjem v veno ali v podkožje.
• Among patients with worsening disease that had come back or failed to respond to at least one other treatment, around 70% responded to treatment with the Velcade-dexamethasone combination.
• med bolniki, katerih bolezen se je poslabšala, ponovila ali se ni odzvala na vsaj eno drugo zdravljenje, je bilo približno 70 % takšnih, ki so se odzvali na zdravljenje s kombinacijo zdravila Velcade in deksametazona.
Velcade is a cancer medicine that contains the active substance bortezomib.
Velcade je zdravilo proti raku, ki vsebuje zdravilno učinkovino bortezomib.
• previously untreated patients who are going to receive high-dose chemotherapy followed by a blood stem-cell transplant.
• predhodno nezdravljenih bolnikih, ki bodo prejeli kemoterapijo v visokih odmerkih, čemur bo sledila presaditev krvnih matičnih celic.
Velcade is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Zdravilo Velcade se uporablja tudi za zdravljenje limfoma plaščnih celic, tj. še ene vrste krvnega raka, pri predhodno nezdravljenih odraslih, pri katerih presaditev krvnih matičnih celic ni mogoča.
In addition, 49% of these patients responded to Velcade plus thalidomide and dexamethasone, compared with about 26% who responded to treatment containing Velcade plus other anticancer drugs, and 17% who responded to thalidomide and dexamethasone alone.
Poleg tega se je 49 % teh bolnikov odzvalo na zdravilo Velcade v kombinaciji s talidomidom in deksametazonom, medtem ko se jih je na zdravljenje s kombinacijami zdravila Velcade in drugih zdravil proti raku odzvalo 26 %, na zdravljenje zgolj s talidomidom in deksametazonom pa 17 %;
Studies in multiple myeloma showed Velcade and combinations containing Velcade to be beneficial in several patient groups.
Študije uporabe pri multiplem mielomu so pokazale, da imajo zdravilo Velcade in kombinacije z zdravilom Velcade koristi pri več skupinah bolnikov.
• patients given Velcade with pegylated liposomal doxorubicin whose disease was getting worse after having failed to respond to at least one other treatment, lived for 9.3 months without their disease getting worse compared to 6.5 months for patients receiving Velcade alone.
• bolniki, ki so prejemali zdravilo Velcade v kombinaciji s pegiliranim liposomalnim doksorubicinom in katerih bolezensko stanje se je poslabšalo, potem ko se niso odzvali na vsaj eno drugo zdravljenje, so živeli 9,3 meseca brez poslabšanja bolezni, bolniki, ki so prejemali samo zdravilo Velcade, pa 6,5 meseca;
In mantle cell lymphoma, patients treated with a combination of Velcade plus rituximab, cyclophosphamide, doxorubicin and prednisone lived longer without their disease getting worse (24.7 months) than those given the same combination but with vincristine in place of Velcade (14.4 months).
Bolniki z limfomom plaščnih celic, ki so jih zdravili s kombinacijo zdravila Velcade in rituksimaba, ciklofosfamida, doksorubicina in prednizona, so živeli dlje časa brez poslabšanja bolezni (24,7 meseca) kot tisti, ki so prejemali enako kombinacijo z vinkristinom namesto zdravila Velcade (14,4 meseca).
• previously untreated adults who cannot have high-dose chemotherapy with a blood stem-cell transplant.
• predhodno nezdravljenih odraslih, ki jih ni mogoče zdraviti s kemoterapijo v visokih odmerkih s sočasno presaditvijo krvnih matičnih celic.
In this study, Velcade together with rituximab, cyclophosphamide, doxorubicin and prednisone was compared with the same combination containing another medicine, vincristine, in place of Velcade.
V tej študiji so zdravilo Velcade v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom primerjali z enako kombinacijo, ki pa je namesto zdravila Velcade vključevala drugo zdravilo vinkristin.
Velcade must not be given by other routes.
Zdravilo Velcade se bolniku ne sme dati na noben drug način.
• Around 15% of patients who were candidates for high-dose chemotherapy and a blood stem-cell transplant responded to treatment with Velcade plus dexamethasone, compared with 6% of those given standard combinations.
• na zdravljenje z zdravilom Velcade v kombinaciji z deksametazonom se je odzvalo okoli 15 % bolnikov, ki so bili primerni za kemoterapijo v visokih odmerkih in presaditev krvnih matičnih celic, v primerjavi s 6 % bolnikov, ki so prejemali standardne kombinacije zdravil.
In these patients, Velcade is used in combination with melphalan and prednisone;
Pri teh bolnikih se zdravilo Velcade uporablja v kombinaciji z melfalanom in prednizonom;
For mantle cell lymphoma, Velcade is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Za zdravljenje limfoma plaščnih celic se zdravilo Velcade uporablja v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom.
How has Velcade been studied?
Kako je bilo zdravilo Velcade raziskano?
What is Velcade used for?
Za kaj se zdravilo Velcade uporablja?
When given into a vein, the solution is given as a three- to five-second injection through a catheter (a thin sterile tube).
Pri injiciranju v veno se raztopina vbrizga skozi kateter (ozko sterilno cevko) v trajanju tri do pet sekund.
Velcade is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone.
Zdravilo Velcade se pri teh bolnikih uporablja bodisi kot samostojno zdravilo bodisi v kombinaciji s pegiliranim liposomalnim doksorubicinom ali deksametazonom.
In this group of patients, Velcade is used in combination with dexamethasone, or with dexamethasone plus thalidomide;
V tej skupini bolnikov se zdravilo Velcade uporablja v kombinaciji z deksametazonom ali pa z deksametazonom in talidomidom;
• Previously untreated patients lived for an average of 20.7 months without their disease getting worse when they received Velcade together with melphalan and prednisone, compared with 15.0 months in the patients receiving only melphalan and prednisone.
• pri predhodno nezdravljenih bolnikih, ki so prejemali zdravilo Velcade v kombinaciji z melfalanom in prednizonom, je do poslabšanja bolezenskega stanja v povprečju prišlo po 20,7 meseca, pri bolnikih, ki so prejemali samo melfalan in prednizon, pa po 15 mesecih;
• Previously patients receiving Velcade lived for an average of 6.2 months without their disease getting worse, compared with 3.5 months in those receiving dexamethasone.
• pri predhodno nezdravljenih bolnikih je do poslabšanja bolezenskega stanja prišlo v povprečju po 6,2 meseca pri tistih, ki so prejemali zdravilo Velcade, in po 3,5 meseca pri tistih, ki so prejemali deksametazon;
What is Velcade?
Kaj je zdravilo Velcade?
How is Velcade used?
Kako se zdravilo Velcade uporablja?
How does Velcade work?
Kako zdravilo Velcade deluje?
The European Commission issued a decision on 19 October 2009.
Evropska komisija je odločbo izdala dne 19. oktobra 2009.
Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by Member States
Člen 30 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev zaradi različnih odločitev, ki so jih sprejele države članice.
21 February 2008
21. februar 2008
Dr. Gonzalo Calvo Rojas (Spain)
dr. Broich (Nemčija) dr. Gonzalo Calvo Rojas (Španija)
Suitability of different types of Augmentin in EU countries
Primernost različnih vrst zdravila Augmentin v državah EU
Company responses provided on: 2 June 2008, 17 November 2008, 19 January 2009, 23 March 2009 and 25 May 2009
2. junija 2008, 17. novembra 2008, 19. januarja 2009, 23. marca 2009 in 25. maja 2009
It can be used in the prevention of some infections.
Uporablja se lahko za preprečevanje določenih okužb.
It is used for the short-term treatment of a number of common infections:
Uporablja se za kratkotrajno zdravljenje številnih pogostih okužb:
The 16:1 ratio is for patients aged at least 16 years.
Razmerje 16:1 je za bolnike, stare vsaj 16 let.
As a result, the antibiotic can work for longer, and is more effective in killing bacteria.
Posledično lahko antibiotik deluje dlje in je učinkovitejši pri uničevanju bakterij.
The review was carried out under an ‘Article 30' referral
Pregled je bil izveden v skladu z napotitvenim postopkom1 iz člena 30.
Co-Rapporteur:
Poročevalec: Soporočevalec:
London, 19 October 2009 Doc.
London, 19. oktobra 2009 Sklic dok.
Augmentin is authorised in the EU via national procedures.
Zdravilo Augmentin je v EU odobreno z nacionalnimi postopki.
Opinion date:
Datum mnenja:
Augmentin is an antibiotic.
Zdravilo Augmentin je antibiotik.
It is also available under other trade names, such as Augmentan, Augmentine, Clavamel, Clavamox, Clavepen, Clavulin, Clavumox, Clavurion, Neoduplamox, Noprilam, Pangamox, Penilan and Spektramox.
Na voljo je tudi pod drugimi trgovskimi imeni, kot so Augmentan, Augmentine, Clavamel, Clavamox, Clavepen, Clavulin, Clavumox, Clavurion, Neoduplamox, Noprilam, Pangamox, Penilan in Spektramox.
• infections of the skin and soft tissues (the structures just below the skin);
• okužb kože in mehkih tkiv (struktur tik pod kožo).
Questions and answers on the referral for Augmentin (amoxicillin and clavulanic acid)
Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Augmentin (amoksicilin in klavulanska kislina)
The European Medicines Agency has completed a review of Augmentin.
Evropska agencija za zdravila je zaključila pregled zdravila Augmentin.
Why was Augmentin reviewed?
Zakaj je bilo zdravilo Augmentin pregledano?
The Committee also harmonised the section listing the types of bacteria against which the medicines is active, and the concentration at which it is effective.
Odbor je uskladil tudi poglavje o vrstah bakterij, proti katerim zdravilo deluje, in pri katerih koncentracijah je učinkovito.
The CHMP recommended that the indication of tonsillitis for Augmentin be removed.
CHMP je priporočil, da se indikacija tonzilitisa za zdravilo Augmentin umakne.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Augmentin in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Augmentin.
The ratio of amoxicillin to clavulanic acid can vary from 16:1 (one gram of amoxicillin to 62.5 mg clavulanic acid) to 2:1 (250 mg of amoxicillin to 125mg of clavulanic acid).
Razmerje med amoksicilinom in klavulansko kislino je lahko različno: od 16:1 (en gram amoksicilina proti 62,5 mg klavulanske kisline) do 2:1 (250 mg amoksicilina proti 125 mg klavulanske kisline).
It can also be used for more serious infections, such as bone or intra-abdominal infections.
Uporablja se lahko tudi za resnejše okužbe, kot so okužbe kosti in okužbe v trebuhu.
The Committee also agreed that the formulations of Augmentin that are made available in each EU country must be tailored to the types of bacteria that are ‘prevalent' in the country, especially their ability to resist the action of certain antibiotics.
Odbor je tudi menil, da je treba formulacije zdravila Augmentin, ki so na voljo v državah EU, prilagoditi vrstam bakterij, ki so pogoste v posamezni državi, zlasti njihovim odpornostim proti delovanju določenih antibiotikov.
The CHMP emphasized that the availability of a medicine containing a certain ratio of amoxicillin:clavulanic acid in one country did not mean that this medicine should also be used in another country.
CHMP je poudaril, da razpoložljivost zdravila z določenim razmerjem med amoksicilinom in klavulansko kislino v eni državi ne pomeni, da se to zdravilo lahko uporablja tudi v drugi državi.
The Committee also recommended that in situations where a higher dose of amoxicillin is required, another preparation of Augmentin should be chosen in order to avoid the patient taking too much clavulanic acid.
Odbor je priporočil tudi, da se v primerih, ko je potreben večji odmerek amoksicilina, izbere drug pripravek zdravila Augmentin, da se prepreči prevelik vnos klavulanske kisline.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SPCs, labelling and package leaflets should be harmonised across the EU.
CHMP je ob upoštevanju predloženih podatkov in znanstvenih razprav v okviru Odbora menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodilo za uporabo uskladiti v celotni EU.
This applies in particular to medicines with a 2:1 or 4:1 ratio, as these, taken at the recommended dose, may not provide a dose of amoxicillin that is sufficient to kill locally prevalent bacteria in areas where there is a high level of resistance to penicillins.
To zlasti velja za zdravila z razmerjem 2:1 ali 4:1, saj ta ob jemanju v priporočenem odmerku morda ne zagotavljajo zadostnega odmerka amoksicilina za uničenje prevladujočih bakterij v področjih z visoko ravnjo odpornosti proti penicilinom.
This has led to divergences in the way the medicine can be used across Member States in which this medicine is approved, as seen in the differences in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the medicines are marketed.
To je v državah članicah, v katerih je zdravilo odobreno, povzročilo razlike glede uporabe zdravila, kakor je razvidno iz povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo v državah, v katerih ima zdravilo dovoljenje za promet.
When Augmentin is absorbed in the body, the amoxicillin component kills the bacteria that are causing the infection, while the clavulanic acid component blocks an enzyme, betalactamase that enable the bacteria to destroy amoxicillin.
Ko se zdravilo Augmentin absorbira v telo, amoksicilinska komponenta uniči bakterije, ki povzročajo okužbo, klavulanska kislina pa zavira encim betalaktamazo, ki bakterijam omogoča uničevanje amoksicilina.
The CHMP harmonised the posology for children, using the patient's weight as the cut-off point to distinguish the dosage for ‘adults and adolescents' (weighing more than 40 kg) from the dosage for children (below 40 kg).
CHMP je uskladil odmerjanje za otroke, pri čemer je bolnikova telesna masa mejna vrednost za ločevanje odmerjanja za „odrasle in mladostnike“ (ki tehtajo več kot 40 kg) in odmerjanja za otroke (manj kot 40 kg).
Previously, Augmentin tablets and suspensions using a 4:1 ratio had been taken twice daily, however the CHMP agreed that a twice-daily dosage was not appropriate as a standard dosage.
Prej so se tablete in suspenzije zdravila Augmentin z razmerjem 4:1 jemale dvakrat na dan, vendar CHMP meni, da takšno odmerjanje ni primerno standardno odmerjanje.
What is Augmentin?
Kaj je zdravilo Augmentin?
On 28 January 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Augmentin in the EU.
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Augmentin v EU, je dne 28. januarja 2008 zadevo napotila na CHMP.
• infections of the urinary tract (the structures that carry urine in the body);
• okužb sečil (strukture v telesu za odvajanje urina);
The CHMP harmonised the information in the SPC on the potential interaction of Augmentin with other medicines, and with some laboratory tests.
CHMP je uskladil podatke v povzetku glavnih značilnosti zdravila o možnem medsebojnem delovanju zdravila Augmentin z drugimi zdravili ter nekaterimi laboratorijskimi preiskavami.
The indications (the diseases the medicine can be used to treat) for the tablets and oral suspensions depend on the ratio of the active substances and have been harmonised to include: acute bacterial sinusitis (adequately diagnosed), acute otitis media, lower respiratory tract infections (such as acute exacerbations of chronic bronchitis and community acquired pneumonia), cystitis, pyelonephritis, and skin and soft tissue infections in particular cellulites, animal bites, severe dental abscess with spreading cellulitis, and bone and joint infections.
Indikacije (bolezni, za zdravljenje katerih se zdravilo lahko uporabi) za tablete in peroralne suspenzije so odvisne od razmerje zdravilnih učinkovin in so bile usklajene, da vključujejo: akutni bakterijski sinuzitis (po ustrezni diagnozi), akutno vnetje srednjega ušesa, okužbe spodnjih dihal (kot so akutna poslabšanja kroničnega bronhitisa in zunajbolnišnično pridobljene pljučnice), cistitis, pielonefritis, okužbe kože in mehkih tkiv, zlasti celulitis, ugrizi živali, resen zobni absces s celulitisom, ki se širi, ter okužbe kosti in sklepov.
Augmentin, also known as ‘coamoxiclav', contains two active substances: amoxicillin, which is an antibiotic belonging to the beta-lactam family (the same family as penicillins), and clavulanic acid, which is a ‘beta-lactamase inhibitor'.
Zdravilo Augmentin, znano tudi pod imenom „koamoksiklav“, vsebuje dve zdravilni učinkovini: amoksicilin, ki je antibiotik iz skupine laktamov beta (iste skupine kot penicilini), in klavulansko kislino, ki je „zaviralec laktamaze beta“.
Augmentin is available as tablets, oral suspensions and solutions for injections or infusion (drip into vein).
Zdravilo Augmentin je na voljo v obliki tablet, peroralne suspenzije in kot raztopina za injiciranje ali infundiranje (kapalne infuzije v veno).
The CHMP harmonised the indications for Augmentin used as an intravenous injection (into a vein) to include certain diseases for which oral treatment is not appropriate: severe infections of the ear, nose and throat, intra-abdominal infections and female genital infections.
CHMP je uskladil indikacije zdravila Augmentin, ki se uporablja kot intravenska injekcija (v veno), z vključitvijo določenih bolezni, pri katerih peroralno zdravljenje ni primerno: hude okužbe ušesa, nosu in žrela, notranje okužbe trebušne votline in okužbe ženskih spolovil.
The Committee harmonised the contra-indications for Augmentin to two contra-indications: in case of hypersensitivity to penicillins, or allergic reaction to other beta-lactam antibiotics, and in case of jaundice or liver problems previously caused by amoxicillin/clavulanic acid.
Odbor je uskladil kontraindikacije zdravila Augmentin in jih oblikoval v dve kontraindikaciji: v primeru preobčutljivosti za peniciline ali alergijske reakcije na druge betalaktamske antibiotike ter v primeru zlatenice ali težav z jetri pri zdravljenju s kombinacijo amoksicilina in klavulanske kisline v preteklosti.
However, the twice-daily dosage can still be used in patients for whom a reduced dose of Augmentin is needed, such as those with problems with their liver or kidneys.
Odbor je sedaj priporočil odmerjanje trikrat na dan. Odmerjanje dvakrat na dan se lahko še vedno uporablja pri bolnikih, ki potrebujejo zmanjšan odmerek zdravila Augmentin, kot so bolniki s težavami z jetri ali ledvicami.
The CHMP also agreed that the injection can be used to prevent infections in major surgeries involving the gut, pelvic cavity, head and neck and the biliary tract.
CHMP je menil tudi, da se lahko injekcija uporabi za preprečevanje okužb pri obsežnejših kirurških posegih, ki obsegajo prebavila, medenično votlino, glavo in vrat ter žolčnik in žolčevod.
Tablets containing amoxicillin and clavulanic acid as a 16:1 ratio should only be used for the treatment of community-acquired pneumonia that is likely to have been caused by penicillin-resistant Streptococcus pneumoniae.
Tablete z amoksicilinom in klavulansko kislino v razmerju 16:1 se lahko uporabljajo le za zdravljenje zunajbolnišnično pridobljene pljučnice, pri kateri je verjetni povzročitelj proti penicilinu odporna bakterija Streptococcus pneumoniae.
The Committee also restricted the use of oral suspensions containing amoxicillin and clavulanic acid as a 14:1 ratio to the treatment of children with acute otitis media and community acquired pneumonia likely to have been caused by penicillin-resistant Streptococcus pneumoniae.
Odbor je tudi omejil uporabo peroralnih suspenzij z amoksicilinom in klavulansko kislino v razmerju 14:1 za zdravljenje otrok z akutnim vnetjem srednjega ušesa ter zunajbolnišnično pridobljeno pljučnico, pri katerih je verjetni povzročitelj proti penicilinu odporna bakterija Streptococcus pneumoniae.
The Committee agreed that the injection can always be used at the start of treatment, before switching to the tablets or oral suspension, for all the disease for which oral treatment is appropriate.
Odbor je menil, da se lahko pri boleznih, za katere je primerno peroralno zdravljenje, na začetku zdravljenja vedno uporabi injekcija, nato pa se preide na tablete ali peroralno suspenzijo.
The Committee harmonised the text of the posology section of the SPC to highlight to prescribers the need to check the appropriateness of the amoxicillin:clavulanic acid ratio to use, looking in particular at the type of bacteria that may be causing infections, the severity and site of infection, and the age, weight and kidney function of the patients.
Odbor je uskladil besedilo poglavja o odmerjanju v povzetku glavnih značilnosti zdravila tako, da bi zdravniki spoznali, da je treba preveriti ustreznost razmerja amoksicilina in klavulanske kisline za želeno uporabo, zlasti z upoštevanjem vrste bakterij, ki verjetno povzroča okužbo, resnosti in mesta okužbe, starosti in telesne mase bolnikov ter njihove ledvične funkcije.
• infections of the respiratory tract (airways and lungs) such as tonsillitis, sinusitis, otitis media
• okužb dihal (dihalnih poti in pljuč), kot so tonzilitis, sinuzitis, vnetje srednjega ušesa, poslabšanje bronhitisa in pljučnica;
The Committee agreed that the tablets and oral suspensions containing amoxicillin and clavulanic acid as a 2:1 ratio should not be used in lower respiratory tract infections or in otitis media.
Odbor se je strinjal, da se tablete in peroralne suspenzije z amoksicilinom in klavulansko kislino v razmerju 2:1 ne smejo uporabljati za okužbe spodnjih dihal ali vnetje srednjega ušesa, ker skupni dnevni odmerek amoksicilina, ki ga zagotavljajo te formulacije ob standardnem odmerjanju, ni zadosten za učinkovito uničenje bakterij, pri velikih odmerkih pa lahko bolnik prejme preveč klavulanske kisline.
It was to be available as 150 mg tablets.
Na voljo naj bi bilo v obliki 150miligramskih tablet.
The company had requested a re-examination of the negative opinion, but withdrew before this re-examination had started.
Družba je zahtevala ponoven pregled negativnega mnenja, vendar je zahtevek umaknila še pred začetkom postopka.
However, the CHMP concluded that the new subgroup of patients proposed for treatment was not well represented in the study (28 patients) and the reliability of the results is questionable.
Vendar pa je CHMP zaključil, da je bila nova podskupina bolnikov, predlagana za zdravljenje, v študiji premajhna (28 bolnikov) in da je zanesljivost rezultatov vprašljiva.
The company informed the CHMP that there are no ongoing clinical trials.
Družba je CHMP obvestila, da trenutno ne potekajo nobena klinična preskušanja.
In its letter notifying the Agency of the withdrawal of application, the company state that it was withdrawing the application for strategic reasons.
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge odločila iz strateških razlogov.
The main measure of effectiveness was the change in vision after six months of treatment measured using a standard eye test with a letter chart.
Glavno merilo učinkovitosti je bila sprememba vida po šestih mesecih zdravljenja, ki so jo ocenili s standardnim očesnim testom s tabelo s črkovnimi znaki.