natgillin/translations-raw huggingface dataset:
The effects of Aflunov were first tested in experimental models before being studied in humans.
Učinki zdravila Aflunov so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Then, the outer membranes that contain the ‘surface antigens' (proteins on the outer membrane of the virus that the body recognises as foreign) were extracted and purified before being included in the vaccine.
Nato so bile zunanje membrane, ki vsebujejo površinske antigene (beljakovine na zunanji membrani virusa, ki ga telo prepoznava kot tujek), izločene in prečiščene, preden so bile ponovno dodane v cepivo.
It consists of a suspension for injection that contains some parts (outer membranes) of the influenza (flu) virus strain called A/VietNam/1194/2004.
Sestavljeno je iz suspenzije za injiciranje, ki vsebuje nekatere dele (zunanje membrane) seva virusa influence (gripa), imenovanega A/VietNam/1194/2004.
An inspection of some of the study sites showed that the study had not been conducted in compliance with ‘good clinical practice' (GCP).
Pregled nekaterih točk študije je namreč razkril, da študija ni bila izvedena v skladu z dobro klinično prakso.
The immune system will be able to produce antibodies more quickly when it is exposed to flu virus of the same strain.
Imunski sistem bo tako lahko proizvedel protitelesa hitreje, kadar bo dejansko izpostavljen virusu gripe istega seva.
Health experts are concerned that the next flu pandemic could be caused by the H5N1 strain of the virus.
Zdravstveni strokovnjaki so zaskrbljeni, da bi naslednjo pandemijo gripe lahko povzročil sev virusa H5N1.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Ko družba predloži odgovore na vprašanja, jih CHMP in lahko pred izdajo svojega mnenja na 180. dan postopka zastavi morebitna druga vprašanja.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravni obrambni sistem telesa) „naučijo“, kako se zaščiti pred boleznijo.
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Potem ko je odbor za zdravila za uporabo v humani medicini ocenil odgovore družbe na seznam vprašanj, so nekatera tehtna vprašanja še vedno ostala nerešena.
The comparator vaccine contained different strains of seasonal flu virus, but the rest of the components were the same as in Aflunov.
Primerjalno cepivo je vsebovalo različne seve virusa sezonske gripe, ostale komponente cepiva pa so bile enake kot pri cepivu Aflunov.
Aflunov is a ‘prepandemic' vaccine.
Zdravilo Aflunov je „predpandemično“ cepivo.
The CHMP was concerned over the way the main clinical study was carried out.
Odbor za zdravila za uporabo v humani medicini je izrazil zadržke zaradi načina izvedbe glavne klinične študije.
Aflunov is a vaccine.
Zdravilo Aflunov je cepivo.
Aflunov was expected to provide protection against this strain, so that it could be used before or during a flu pandemic.
Zdravilo Aflunov naj bi zagotovilo zaščito pred tem sevom in bi se lahko uporabljalo pred ali med pandemijo gripe.
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 Aflunov could not have been approved for the prophylaxis of H5N1 avian influenza.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Aflunov ni mogoče odobriti za zaščito pred virusom H5N1 aviarne influence.
It compared Aflunov's safety and its ability to stimulate the production of antibodies (‘immunogenicity') with those of a similar vaccine against seasonal flu.
Študija je primerjala varnost zdravila Aflunov in njegovo zmožnost za spodbujanje proizvodnje protiteles (imunogenost), v primerjavi s podobnimi cepivi proti sezonskim virusom gripe.
Aflunov contains small parts of the H5N1 strain of the flu virus.
Zdravilo Aflunov vsebuje majhne delce H5N1 seva virusa gripe.
The company informed the CHMP that there are no consequences for individuals currently included in clinical trials with Aflunov.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih cepiva Aflunov.
When a person is given the vaccine, the immune system recognises the parts of the flu virus it contains as ‘foreign' and makes antibodies against them.
Kadar posameznik prejme cepivo, imunski sistem prepozna dele virusa, ki ga le-to vsebuje, kot tuje in proti njim pripravi protitelesa.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Pandemija gripe nastopi, kadar se pojavi nov sev virusa gripe, ki se zlahka širi med ljudmi, saj posamezniki pred njim niso imuni (nimajo zaščite).
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for AFLUNOV Common name: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (A/VietNam/1194/2004)
Splošno ime: Cepivo za predpandemično influenco (H5N1) (površinski antigen, inaktiviran, adjuvant) (A/VietNam/1194/2004)
The application was at day 190 when the company withdrew.
Družba je vlogo umaknila na 190. dan postopka.
What is Aflunov?
Kaj je zdravilo Aflunov?
What are the consequences of the withdrawal for patients undergoing clinical trials with Aflunov?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe cepiva Aflunov?
Aflunov was expected to be used in adults and the elderly to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Zdravilo Aflunov naj bi se uporabljalo pri odraslih in starejših za zaščito pred gripo, ki jo povzroča H5N1, sev (vrsta) virusa influence A.
officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aflunov, for the prophylaxis of H5N1 avian influenza in adults and the elderly.
je dne 13. junija 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Aflunov, namenjenemu zaščiti pred virusom aviarne influence H5N1, pri odraslih in starejših.
What was Aflunov expected to be used for?
Za kaj naj bi se zdravilo Aflunov uporabljalo?
How is Aflunov expected to work?
Kako naj bi zdravilo Aflunov delovalo?
Therefore, at the time of the withdrawal, the CHMP could not conclude on the benefit-risk balance of Aflunov.
Odbor za zdravila za uporabo v humani medicini je v času umika menil, da ne more sklepati o razmerju med koristmi in tveganji za cepivo Aflunov.
The European Commission granted a marketing authorisation valid throughout the European Union for Bondronat on 25 June 1996.
Evropska komisija je dovoljenje za promet z zdravilom Bondronat, veljavno po vsej Evropski uniji, izdala 25. junija 1996.
Bondronat is used in adults in the following ways:
Zdravilo Bondronat se uporablja pri odraslih na naslednje načine:
The full EPAR for Bondronat can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Bondronat je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Bondronat?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bondronat?
The main measure of effectiveness was based on the number of new bone complications.
Glavno merilo učinkovitosti je temeljilo na številu novih z okostjem povezanih zapletov.
Other information about Bondronat
Druge informacije o zdravilu Bondronat
The main measure of effectiveness was the change in blood calcium levels.
Glavno merilo učinkovitosti je bila sprememba ravni kalcija v krvi.
This is a summary of the European public assessment report (EPAR) for Bondronat.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bondronat.
Bondronat treatment should only be started by a doctor who has experience in the treatment of cancer.
Zdravljenje z zdravilom Bondronat lahko začne le zdravnik z izkušnjami pri zdravljenju raka.
This leads to less bone loss.
S tem se zmanjša izguba kostnine.
What benefit has Bondronat shown during the studies?
Kakšne koristi je zdravilo Bondronat izkazalo med študijami?
For more information about treatment with Bondronat, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Bondronat preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
About three-quarters responded to a 4-mg dose.
Približno tri četrtine bolnikov se je odzvalo na 4-miligramski odmerek.
A risk management plan has been developed to ensure that Bondronat is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Bondronat je bil pripravljen načrt obvladovanja tveganj.
Bondronat must not be used in people with hypocalcaemia.
Zdravila Bondronat ne smejo uporabljati osebe s hipokalciemijo.
The infusion will normally bring the blood calcium level down to normal levels within a week.
Običajno se bo z infundiranjem raven kalcija v krvi v tednu dni znižala na normalno raven.
Bondronat reduced the risk of having a skeletal event by about 40% compared with placebo.
Zdravilo Bondronat je v primerjavi s placebom zmanjšalo tveganje z okostjem povezanih dogodkov za približno 40 %.
Bondronat was more effective than placebo in preventing bone complications.
Zdravilo Bondronat je bilo učinkovitejše od placeba pri preprečevanju z okostjem povezanih zapletov.
Bondronat was not compared with any other treatments in these studies.
V teh študijah zdravila Bondronat niso primerjali z nobeno drugo vrsto zdravljenja.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Zavira delovanje osteoklastov, tj. celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
Bondronat ibandronic acid
Bondronat ibandronska kislina
The CHMP decided that Bondronat's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Bondronat večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
It is available as a concentrate that is made up into a solution for infusion (drip) into a vein, and as tablets (50 mg).
Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno in tablet (50 mg).
The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit up for at least an hour.
Tablet ne smejo jemati bolniki z nepravilnostmi v požiralniku ali tisti, ki ne morejo stati ali sedeti vzravnano vsaj eno uro.
• as an infusion to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
• kot infuzija za zdravljenje hiperkalciemije (visokih ravni kalcija v krvi), ki jo povzročajo tumorji.
In addition, the company that markets Bondronat will provide a card to inform patients receiving Bondronat infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Poleg tega bo družba, ki trži zdravilo Bondronat, pripravila kartico, s katero bo bolnike, ki prejemajo infuzije tega zdravila, seznanila s tveganjem pojava osteonekroze čeljustne kosti in jih pozvala, naj v primeru pojava simptomov poiščejo zdravniško pomoč.
Bondronat has also been studied in the treatment of hypercalcaemia caused by tumours in three fourweek studies involving a total of 343 patients.
Zdravilo Bondronat je bilo raziskano tudi z vidika zdravljenja tumorsko povzročene hiperkalciemije v treh štiritedenskih študijah, v katere je bilo vključenih skupaj 343 bolnikov.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bondronat, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What is the risk associated with Bondronat?
Kakšna tveganja so povezana z zdravilom Bondronat?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bondronat.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Bondronat, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
About a half to two-thirds of the patients responded to a 2-mg dose of Bondronat, with blood calcium levels returning to within the normal range.
Približno polovica do dve tretjini bolnikov se je odzvalo na 2-miligramski odmerek zdravila Bondronat tako, da so se ravni kalcija v krvi znižale na normalno vrednost.
In the treatment of hypercalcaemia caused by tumours, Bondronat is given over 2 hours as an infusion of either 2 or 4 mg, depending on how severe the hypercalcaemia is.
Pri zdravljenju tumorsko povzročene hiperkalciemije se zdravilo Bondronat daje v obliki dvourne infuzije v odmerku 2 ali 4 mg, odvisno od resnosti hiperkalciemije.
Patients with moderate or severe kidney problems should receive Bondronat infusions at a lower dose over an hour, or the tablet every two days or every week.
Bolniki z zmernimi ali hudimi ledvičnimi težavami morajo infuzije zdravila Bondronat prejemati v nižjem odmerku z infundiranjem, ki traja eno uro, ali vzeti tablete vsaka dva dni ali vsak teden.
Patients with tumours can have high levels of calcium in their blood, released from the bones.
Bolniki s tumorji lahko imajo v krvi visoke ravni kalcija, ki se sprošča iz kosti.
The most serious side effects with Bondronat are anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth), and eye inflammation.
Najresnejši neželeni učinki zdravila Bondronat so anafilaktične reakcije (hude alergijske reakcije), neznačilni zlomi stegnenice (neobičajne vrste zloma kosti v stegnu), osteonekroza čeljusti (poškodbe čeljustne kosti, ki lahko povzroči bolečine, oteklost v ustih ali majanje zob) ter vnetje oči.
It took longer for patients on Bondronat infusions or tablets to develop a new bone complication (50 to 76 weeks) than for patients on placebo (33 to 48 weeks).
Pri bolnikih, ki so prejemali injekcije ali tablete zdravila Bondronat, so se novi z okostjem povezani zapleti pojavili kasneje (po 50 do 76 tednih) kot pri bolnikih, ki so prejemali placebo (po 33 do 48 tednih).
The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Zmanjševanje izgubljanja kostnine vpliva na manjšo lomljivost kosti, kar je koristno pri preprečevanju zlomov pri bolnikih z rakom, ki imajo metastaze v kosteh.
In the prevention of skeletal events in patients with breast cancer and bone metastases, Bondronat has been compared with placebo (a dummy treatment) in three main studies lasting two years: one with the infusions in 466 patients and two with the tablets in a total of 846 patients.
Zdravilo Bondronat so pri preprečevanju z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh primerjali s placebom (zdravilom brez zdravilne učinkovine) v treh glavnih študijah, ki so trajale dve leti: v eni z infuzijami pri 466 bolnikih in v dveh s tabletami pri skupaj 846 bolnikih.
• as an infusion or as a tablet to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);
• kot infuzija ali tableta za preprečevanje z okostjem povezanih dogodkov (zlomov kosti ali zapletov s kostmi, pri katerih je potrebno zdravljenje) pri bolnikih z rakom dojke in metastazami v kosteh
These included spine fractures, fractures outside the spine and any bone complications that needed treatment with radiotherapy or surgery.
Ti so vključevali zlome hrbtenice, zlome na drugih mestih in vse z okostjem povezane zaplete, pri katerih je bilo potrebno obsevanje ali kirurški poseg.
Bondronat is a medicine that contains the active substance ibandronic acid.
Bondronat je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
Why has Bondronat been approved?
Zakaj je bilo zdravilo Bondronat odobreno?
where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used).
Tableto mora vzeti s polnim kozarcem navadne vode (na območjih s trdo vodo, kjer voda iz pipe vsebuje veliko raztopljenega kalcija, se lahko uporabi ustekleničena voda z nizko vsebnostjo mineralov).
For the full list of all side effects and restrictions reported with Bondronat, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bondronat, glejte navodilo za uporabo.
The most common side effects with Bondronat infusions are a rise in body temperature, hypocalcaemia (low blood calcium levels), asthenia (weakness) and headache.
Najpogostejši neželeni učinki pri infuzijah zdravila Bondronat so povišana telesna temperatura, hipokalciemija (nizke ravni kalcija v krvi), astenija (šibkost) in glavobol.
By preventing the breakdown of bones, Bondronat also helps to reduce the amount of calcium released into the blood.
Zdravilo Bondronat s preprečevanjem razgradnje kosti pripomore tudi k znižanju ravni kalcija, ki se sprosti v kri.
The patient should not lie down for one hour after taking the tablet.
Vsaj eno uro po zaužitju tablete ne sme leči.
The active substance in Bondronat, ibandronic acid, is a bisphosphonate.
Zdravilna učinkovina v zdravilu Bondronat, ibandronska kislina, je difosfonat.
Bondronat was also effective in treating hypercalcaemia caused by tumours.
Zdravilo je bilo učinkovito tudi pri zdravljenju tumorsko povzročene hiperkalciemije.
The most common side effects with the tablets are hypocalcaemia and dyspepsia (heartburn).
Najpogostejša neželena učinka pri jemanju tablet sta hipokalciemija in dispepsija (zgaga).
The tablet should be taken after the patient has not eaten anything for at least six hours overnight and at least 30 minutes before the first food or drink of the day.
Pri preprečevanju z okostjem povezanih dogodkov se zdravilo Bondronat daje kot 6-miligramska infuzija v trajanju najmanj 15 minut vsake tri do štiri tedne ali kot ena tableta enkrat na dan. Tableto mora bolnik vedno vzeti zjutraj na tešče, ko ni jedel vsaj šest ur, in vsaj 30 minut pred prvim obrokom ali pijačo.
How has Bondronat been studied?
Kako je bilo zdravilo Bondronat raziskano?
What is Bondronat used for?
Za kaj se zdravilo Bondronat uporablja?
How is Bondronat used?
Kako se zdravilo Bondronat uporablja?
How does Bondronat work?
Kako zdravilo Bondronat deluje?
What is Bondronat?
Kaj je zdravilo Bondronat?
Intravenous use vial (glass) 12 (12x1) vials (multipack)
12 (12 × 1) vial (skupno pakiranje)
(Invented) name Strength Pharmaceutical form
Jakost Farmacevtska oblika
Convincing data to identify a patient population in which the benefits of meprobamate clearly outweigh its identified risks.
prepričljive podatke z opredelitvijo populacije bolnikov, v kateri koristi meprobamata jasno odtehtajo opredeljena tveganja.
Annex III Conditions for lifting the suspension of the marketing authorisations
Dodatek III Pogoji za odpravo začasnega umika dovoljenj za promet z zdravilom
For the suspension to be lifted, the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Za odpravo začasnega umika morajo imetniki dovoljenja za promet z zdravilom pristojnim nacionalnim organom predložiti naslednje:
MA (EU) number (Invented) name
Številka (EU) dovoljenja za promet
2 sets of constituents
Za infundiranje Steklene viale 2 kompleta sestavin
1 set of constituents
Za infundiranje Steklene viale 1 komplet sestavin
However, the following efficacy and safety issues were addressed:
Vendar pa so bili obravnavani naslednji vidiki učinkovitosti in varnosti:
Results continuously improved with increasing experience over the course of 11 years.
Rezultati so se v teku 11 let s povečevanjem izkušenj nenehno izboljševali.
The three studies demonstrated similar survival rates.
Te tri študije so pokazale podobne deleže preživetja.
To date, no other relevant epidemiological data are available.
Doslej ni na voljo drugih pomembnih epidemioloških podatkov.
You should keep in regular contact with your doctor.
Redno morate biti v stiku s svojim zdravnikom.
Approximately 2% of the radioactivity was eliminated in the urine.
Približno 2 % radioaktivnosti sta se izločila v urinu.
Belgium, Luxembourg, The Netherlands.
Belgija, Luksemburg, Nizozemska.
The divergences identified at the start of the referral have been resolved.
Razhajanja, ugotovljena na začetku napotitvenega postopka, so bila odpravljena.
Your doctor will tell you exactly how many capsules to take and how often.
Zdravnik vam bo natančno povedal, koliko kapsul morate jemati in kako pogosto.
Austria, Cyprus, Czech Republic, Denmark, Germany, Greece, Spain, Finland, France, Hungary, Ireland, Italy, Norway, Poland, Portugal, Slovakia, Slovenia, Sweden,United Kingdom.
Avstrija, Ciper, Češka republika, Danska, Nemčija, Grčija, Španija, Finska, Francija, Madžarska, Irska, Italija, Norveška, Poljska, Portugalska, Slovaška, Slovenija, Švedska, Velika Britanija.
The course of preexisting infections may be aggravated.
Potek obstoječih okužb se lahko poslabša.
Efficacy results of the largest studies in each indication are summarised below.
Rezultati o učinkovitosti iz največjih študij za vsako indikacijo so povzeti spodaj.
The use of live attenuated vaccines should be avoided.
Izogniti se je treba uporabi živih oslabljenih cepiv.
The recommended initial dosages presented below are intended to act solely as a guideline.
Spodaj navedeni priporočeni začetni odmerki so namenjeni le kot smernice.
Section on contraindications (4.3) remained unchanged.
Poglavje o kontraindikacijah (4.3) je ostalo nespremenjeno.
Your doctor will advise you on the best course of action.
Zdravnik vam bo svetoval, kako je najbolje ravnati.
28223 Pozuelo de Alarcón (Madrid) Spain
28223 Pozuelo de Alarcón (Madrid) Španija
The capsules should be swallowed whole with a glass of water.
Kapsule morate zaužiti cele, s kozarcem vode.
In addition, synergistic/additive nephrotoxic effects can occur.
Poleg tega se lahko pojavijo sinergistični/aditivni nefrotoksični učinki.
2600 Glostrup Denmark
2600 Glostrup Danska
Box 25676
P.O. Box 25676
Intravenous therapy should not be continued for more than 7 days.
Intravensko zdravljenje ne sme trajati več kot 7 dni.
Your dose depends on your general condition and on which other immunosuppressive medication you are taking.
Vaš odmerek je odvisen od vašega splošnega stanja in od tega, katera druga imunosupresivna zdravila jemljete.
Possible side effects are listed according to the following categories:
Možni neželeni učinki so našteti po naslednjih skupinah:
Do not stop your treatment unless your doctor tells you to do so.
Ne prekinjajte zdravljenja, če vam tega ne naroči zdravnik.
Both generalised and localised infections can occur.
Pojavijo se lahko generalizirane in lokalizirane okužbe.