natgillin/translations-raw huggingface dataset:
Since Aerivio Spiromax is only available in one high strength (containing 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate), should a lower strength become appropriate, patients should be switched to an alternative combination of salmeterol and fluticasone propionate containing a lower
Ker je zdravilo Aerivio Spiromax na voljo samo v eni visoki jakosti (ta vsebuje 50 mikrogramov salmeterola in 500 mikrogramov flutikazonpropionata), morajo v primeru, da postane primerna nižja jakost, bolniki preiti na alternativno kombinacijo salmeterola in flutikazonpropionata, ki vsebuje manjši odmerek
What measures are being taken to ensure the safe and effective use of Aerivio Spiromax?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Aerivio Spiromax?
Patients should be regularly assessed by a doctor to ensure that they receive the lowest dose sufficient to control symptoms.
Priporočeni odmerek je ena inhalacija dvakrat na dan. Bolnike mora redno pregledovati zdravnik, ki poskrbi za to, da prejemajo najmanjši zadosten odmerek za nadzor simptomov.
The Committee recommended that Aerivio Spiromax be approved for use in the EU.
Priporočil je, da se zdravilo Aerivio Spiromax odobri za uporabo v EU.
Because Aerivio Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Aerivio Spiromax hibridno zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aerivio Spiromax have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Aerivio Spiromax upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
In asthma, Aerivio Spiromax can be used in patients whose disease is not adequately controlled despite treatment with a combination of a beta-2 agonist and a lower dose of inhaled corticosteroid, or those whose asthma is already controlled with a long-acting beta-2 agonist and a high-dose of inhaled
Pri astmi se lahko zdravilo Aerivio Spiromax uporablja pri bolnikih, pri katerih bolezen ni pod ustreznim nadzorom kljub zdravljenju s kombinacijo agonista adrenergičnih receptorjev beta-2 in manjšega odmerka inhalacijskega kortikosteroida, in pri bolnikih, pri katerih je astma nadzorovana že z dolgodelujočim agonistom adrenergičnih receptorjev beta-2 in velikim odmerkom inhalacijskega
Aerivio Spiromax is a ‘hybrid medicine'.
Zdravilo Aerivio Spiromax je „hibridno zdravilo“.
However, Aerivio Spiromax is available only as a single high strength, whereas the reference medicine is available in three strengths, the same high strength and two lower strengths.
Vendar je zdravilo Aerivio Spiromax na voljo samo v eni visoki jakosti, referenčno zdravilo pa je na voljo v treh jakostih, in sicer enaki visoki jakosti in dveh nižjih jakostih.
Other information about Aerivio Spiromax
Druge informacije o zdravilu Aerivio Spiromax
In COPD, Aerivio Spiromax is used in adults who have had exacerbations (flare-ups) of the disease in the past and have significant symptoms despite regular treatment.
Pri KOPB se zdravilo Aerivio Spiromax uporablja pri odraslih s poslabšanji (izbruhi) bolezni v preteklosti, ki imajo izrazite simptome kljub rednemu zdravljenju.
Aerivio Spiromax is a medicine used for the regular treatment of adults with severe asthma and for the relief of symptoms of chronic obstructive pulmonary disease (COPD, a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing).
Aerivio Spiromax je zdravilo, ki se uporablja za redno zdravljenje odraslih s hudo astmo in za lajšanje simptomov kronične obstruktivne pljučne bolezni (KOPB, dolgotrajna bolezen, pri kateri pride do poškodbe ali zapore dihalnih poti in zračnih mešičkov v pljučih, kar oteži dihanje).
The two active substances in Aerivio Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Zdravilni učinkovini v zdravilu Aerivio Spiromax sta dobro znani in sta prisotni v več zdravilih, ki se samostojno ali v kombinaciji z drugimi zdravili uporabljajo za zdravljenje astme in KOPB.
What are the benefits and risks of Aerivio Spiromax?
Kakšne so koristi in tveganja, povezani z zdravilom Aerivio Spiromax?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Aerivio Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo Aerivio Spiromax primerljivo raven kakovosti kot zdravilo Seretide Diskus ter da mu je biološko enakovredno.
For more information about treatment with Aerivio Spiromax, read the package leaflet (also part of the EPAR) or contact your
Za več informacij o zdravljenju z zdravilom Aerivio Spiromax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Studies in people have been limited to tests to determine that Aerivio Spiromax is bioequivalent to the reference medicine, Seretide Diskus.
Študije pri bolnikih so bile omejene na preskuse za ugotavljanje, ali je zdravilo Aerivio Spiromax biološko enakovredno referenčnemu zdravilu Seretide Diskus.
Aerivio Spiromax is available as an inhalation powder in a portable inhaler device.
Na voljo je v obliki praška za inhaliranje v prenosnem inhalatorju.
What is Aerivio Spiromax and what is it used for?
Kaj je zdravilo Aerivio Spiromax in za kaj se uporablja?
It is not intended to provide practical advice on how to use Aerivio Spiromax.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For practical information about using Aerivio Spiromax, patients should read the package leaflet or
Za praktične informacije o uporabi zdravila Aerivio Spiromax naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
As Aerivio Spiromax is only available in one high strength, its use in asthma has been restricted to
Spiromax na voljo samo v eni visoki jakosti, je njegova uporaba pri astmi omejena na bolnike s hudo obliko bolezni.
How has Aerivio Spiromax been studied?
Kako je bilo zdravilo Aerivio Spiromax raziskano?
Aerivio Spiromax can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Aerivio Spiromax je le na recept.
How is Aerivio Spiromax used?
Kako se zdravilo Aerivio Spiromax uporablja?
The amount of besilesomab injected varies between 0.25 to 1 mg, depending on how much radioactivity is required.
Količina injiciranega besilesomaba se giblje od 0,25 do 1 mg, odvisno od potrebe po radioaktivnosti.
What measures are being taken to ensure the safe and effective use of Scintimun?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Scintimun?
The full EPAR for Scintimun 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 Scintimun je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Scintimun.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Scintimun.
As for all radioactive substances used in medicine, patients should be exposed to the lowest possible dose of Scintimun.
Kot pri vseh radioaktivnih učinkovinah v medicini naj bodo bolniki izpostavljeni najmanjšim možnim odmerkom zdravila Scintimun.
In addition the company that makes Scintimun will make sure that all doctors who are expected to use it are provided with a letter explaining the risks associated with the medicine.
Poleg tega bo družba, ki proizvaja zdravilo Scintimun, poskrbela, da bodo zdravniki, ki naj bi zdravilo uporabljali, prejeli dopis, ki pojasnjuje tveganja, povezana z zdravilom.
Scintimun should only be used in hospitals with a nuclear medicine department and should only be handled by authorised staff.
Zdravilo Scintimun se lahko uporablja le v bolnišnicah z oddelkom nuklearne medicine, z njim pa lahko rokujejo le pooblaščene osebe.
Patients limbs were then scanned and the images obtained using both techniques were compared.
Okončine so nato slikali in slike, dobljene z obema tehnikama primerjali med seboj.
For more information about treatment with Scintimun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Scintimun preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Radiolabelling is a technique where a substance is labelled with a radioactive compound.
Radioaktivno označevanje je tehnika, pri kateri se snov označi z radioaktivno snovjo.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je oblikovana tako, da prepozna specifično strukturo (imenovano antigen), ki se nahaja v telesu, in se veže nanjo.
Scintimun is not used on its own, but must be radiolabelled before use.
Zdravilo Scintimun se ne uporablja samostojno, ampak mora biti pred uporabo radioaktivno označeno.
Scintimun should not be used to diagnose diabetic foot infection (infection that occurs in the feet of patients with diabetes).
Zdravilo Scintimun se ne sme uporabljati za diagnozo okužbe diabetičnega stopala (okužbe, ki nastane v stopalih bolnikov s sladkorno boleznijo).
Other information about Scintimun
Druge informacije o zdravilu Scintimun
Besilesomab has been designed to attach to an antigen called NCA-95, which is found on the surface of granulocytes, a type of white blood cell involved in inflammation and fighting infection.
Besilesomab je zasnovan za vezavo na antigen, imenovan NCA-95, ki se nahaja na površini granulocitov, vrsti belih krvnih celic, ki sodelujejo pri vnetjih in boju proti okužbi.
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 Scintimun.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The most common side effect with Scintimun (seen in more than 1 patient in 10) is the production of anti-mouse antibodies.
Najpogostejši neželeni učinek zdravila Scintimun (opažen pri več kot 1 bolniku od 10) je tvorba protiteles proti mišjim protitelesom.
What benefit has Scintimun shown during the studies?
Kakšne koristi je zdravilo Scintimun izkazalo med študijami?
The CHMP decided that Scintimun's benefits are greater than its risks.
CHMP je zaključil, da so koristi zdravila Scintimun večje od z njim povezanih tveganj.
A risk management plan has been developed to ensure that Scintimun is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Scintimun je bil pripravljen načrt obvladovanja tveganj.
Three to six hours after the injection, the doctor takes a scan of the limbs to locate the areas in the bones affected by osteomyelitis.
Tri do šest ur po injiciranju zdravnik slika okončine, da bi v kosteh določil področja, ki jih je prizadel osteomielitis.
The solution is given to the patient as one injection into a vein.
Raztopina se daje bolniku v obliki enega injiciranja v veno.
What is the risk associated with Scintimun?
Kakšna tveganja so povezana z zdravilom Scintimun?
The European Commission granted a marketing authorisation valid throughout the European Union for Scintimun on 11 January 2010.
Evropska komisija je dovoljenje za promet z zdravilom Scintimun, veljavno po vsej Evropski uniji, izdala11.
In one main study in 130 patients who had or were suspected to have osteomyelitis in their limbs, radiolabelled Scintimun was compared with a standard diagnostic technique using the patients' own white blood cells that were radiolabelled before being injected back into the patient.
V eni glavni študiji so pri 130 bolnikih, ki so imeli ali je obstajal sum, da imajo, osteomielitis v okončinah, radioaktivno označeno zdravilo Scintimun primerjali s standardno diagnostično tehniko, pri kateri se radioaktivno označijo bolnikove lastne bele krvne celice, preden se injicirajo nazaj v telo.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Scintimun, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The Committee recommended that Scintimun be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Scintimun izda dovoljenje za promet.
Scintimun must not be used in people who are hypersensitive (allergic) to besilesomab, to other mouse antibodies or to any of the other ingredients.
Zdravilo Scintimun se ne sme uporabljati pri osebah, ki so preobčutljive za (alergične na) besilesomab, na druga mišja protitelesa ali katero koli drugo sestavino zdravila.
When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target antigen on the granulocytes.
Ob injiciranju radioaktivno označenega zdravila v bolnika monoklonsko protitelo radioaktivnost prenese do ciljnega antigena na granulocitih.
As large numbers of granulocytes gather at the site of an infection, the radioactivity will accumulate in areas affected by osteomyelitis, where it can be detected by scans.
Ker se na mestu okužbe nabere veliko število granulocitov, se bo radioaktivnost kopičila na območjih, ki jih je prizadel osteomielitis, to pa je opazno na slikah.
The active substance in Scintimun, besilesomab, is a monoclonal antibody.
Zdravilna učinkovina zdravila Scintimun, besilesomab, je monoklonsko protitelo.
Why has Scintimun been approved?
Zakaj je bilo zdravilo Scintimun odobreno?
The images will show where besilesomab has accumulated, which the doctor will use to locate the areas of infection or inflammation.
Iz slik bo razvidno, kje se je nakopičil besilesomab, zdravnik pa bo tako določil mesto okužbe ali vnetja.
Scintimun must not be used in patients who have tested positive for human anti-mouse antibody (HAMA) and must not be used in pregnant women.
Zdravila Scintimun ne smejo uporabljati osebe, ki imajo pozitivni test za človeška protitelesa proti mišjim protitelesom (HAMA), in nosečnice.
It contains the active substance besilesomab.
Vsebuje zdravilno učinkovino besilesomab.
Scintimun is a kit for the preparation of a radioactive solution for injection.
Zdravilo Scintimun je komplet za pripravo radioaktivne raztopine za injiciranje.
The main measure of effectiveness for Scintimun was based on how much the assessment of the images obtained with Scintimun agreed with that obtained with the radiolabelled white blood cells.
Glavno merilo učinkovitosti za zdravilo Scintimun je temeljilo na tem, kako so se ocene slik bolnikov, ki so prejemali zdravilo Scintimun, ujemale s tistimi, dobljenimi pri bolnikih, ki so prejemali zdravilo z radioaktivno označenimi belimi krvnimi celicami.
For the full list of all side effects reported with Scintimun, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Scintimun, glejte navodilo za uporabo.
The agreement rate was 83%.
Stopnja ujemanja je bila
A radioactive Scintimun solution is made by mixing the powder and solvent provided in the kit and then radiolabelling it with technetium (99mTc).
Radioaktivna raztopina zdravila Scintimun se pripravi z mešanjem praška in vehikla, priloženih v kompletu, nato se radioaktivno označi s tehnecijem (99mTc).
What is Scintimun used for?
Za kaj se zdravilo Scintimun uporablja?
When Scintimun is radiolabelled, the radioactive compound technetium (99mTc) becomes attached to besilesomab.
Ko je zdravilo Scintimun radioaktivno označeno, se radioaktivna spojina tehnecij (99mTc) veže na besilesomab.
Scintimun is for diagnostic use only.
Zdravilo Scintimun je samo za diagnostične namene.
What is Scintimun?
Kaj je zdravilo Scintimun?
How has Scintimun been studied?
Kako je bilo zdravilo Scintimun raziskano?
It is used to locate areas of infection or inflammation in adults with suspected osteomyelitis (bone infection) in the limbs, in combination with other appropriate imaging methods.
V kombinaciji z drugimi primernimi metodami slikanja se uporablja za odkrivanje mesta okužbe ali vnetja pri odraslih s sumom na osteomielitis (okužbo kosti) v okončinah.
Scintimun is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
Zdravilo Scintimun se radioaktivno označuje z raztopino radioaktivnega tehnecija (99mTc).
How is Scintimun used?
Kako se zdravilo Scintimun uporablja?
Scintimun produced comparable results to the radiolabelled white blood cells when used to diagnose and locate osteomyelitis in limbs.
Rezultati zdravila Scintimun so bili pri diagnosticiranju in lokalizaciji osteomielitisa v okončinah primerljivi z zdravilom z radioaktivno označenimi belimi krvnimi celicami.
How does Scintimun work?
Kako zdravilo Scintimun deluje?
It works by blocking the production of bacterial proteins, thus preventing the growth of the bacteria.
Deluje tako, da zavira nastajanje beljakovin bakterij in tako preprečuje rast bakterij.
The company plans to include these data in a new marketing authorisation application in the EU.
Družba načrtuje, da bo te podatke vključila v novo vlogo za pridobitev dovoljenja za promet z zdravilom v EU.
In its letter notifying the Agency of the withdrawal of the application, the company stated that its decision to withdraw is based on a request from the US FDA to provide additional safety data to support approval in the US.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da njena odločitev o umiku vloge temelji na zahtevi agencije ZDA za zdravila in prehrano (FDA) po predložitvi dodatnih varnostnih podatkov v podporo odobritvi zdravila v ZDA.
No studies in patients with inhaled anthrax or inhaled tularaemia have been carried out and the company presented data from laboratory studies.
Pri bolnikih z inhalacijskim vraničnim prisadom ali inhalacijsko tularemijo ni bilo izvedenih nobenih študij, družba pa je predstavila podatke iz laboratorijskih študij.
There were also concerns that solithromycin could be harmful to the liver.
Obstajali so tudi zadržki, da lahko solitromicin škoduje jetrom.
In addition, it had concerns about the manufacturing process of the active substance, which did not exclude the presence of impurities, and the test for ensuring sterility of the product for infusion was not considered valid.
Poleg tega je izrazil zadržke tudi o proizvodnem postopku zdravilne učinkovine, ki ni izključeval prisotnosti nečistot, preskus zagotavljanja sterilnosti zdravila za infundiranje pa ni bil ocenjen kot veljaven.
• community-acquired pneumonia (an infection of the lungs caught outside of hospital);
• zunajbolnišnične pljučnice (okužbe pljuč, pridobljene zunaj bolnišnice);
The company presented data from three studies in a total of 1,855 patients with community-acquired pneumonia, in which Solithromycin Triskel EU Services was compared with other antibiotics (levofloxacin and moxifloxacin).
Družba je predstavila podatke iz treh študij, ki so skupaj vključevale 1 855 bolnikov z zunajbolnišnično pljučnico, v katerih so zdravilo Solithromycin Triskel EU Services primerjali z drugima antibiotikoma (levofloksacinom in moksifloksacinom).
• inhaled tularaemia (another serious disease caught by inhaling bacteria).
• inhalacijske tularemije (še ene hude bolezni, pridobljene z vdihavanjem bakterij).
The active substance in Solithromycin Triskel EU Services, solithromycin, is a type of antibiotic similar to a group of antibiotics known as ‘macrolides'.
Zdravilna učinkovina v zdravilu Solithromycin Triskel EU Services, solitromicin, je vrsta antibiotika, podobnega skupini antibiotikov, znanih kot „makrolidi“.
Solithromycin Triskel EU Services was expected to be used to treat the following bacterial infections:
Zdravilo Solithromycin Triskel EU Services naj bi se uporabljalo za zdravljenje naslednjih bakterijskih okužb:
It was to be available as capsules to be taken by mouth and as a powder to be made into a solution for infusion (drip) into a vein.
Na voljo naj bi bilo v obliki kapsul za peroralno uporabo in v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Solithromycin Triskel EU Services.
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Solithromycin Triskel EU Services.
On 27 March 2017, Triskel EU Services Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Solithromycin Triskel EU Services, intended for the treatment of community-acquired pneumonia, inhaled anthrax and inhaled tularaemia.
Družba Triskel EU Services Ltd je 27. marca 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Solithromycin Triskel EU Services, namenjenim zdravljenju zunajbolnišnične pljučnice, inhalacijskega vraničnega prisada in inhalacijske tularemije.
The CHMP was concerned that not enough data had been provided to support use in inhaled anthrax and inhaled tularaemia.
Odbor CHMP je izrazil zadržke, da ni bilo dovolj predloženih podatkov v podporo uporabi pri inhalacijskem vraničnem prisadu in inhalacijski tularemiji.
Solithromycin Triskel EU Services is a medicine that contains the active substance solithromycin.
Solithromycin Triskel EU Services je zdravilo, ki vsebuje zdravilno učinkovino solitromicin.
• inhaled anthrax (the most serious form of anthrax caught by inhaling bacterial spores);
• inhalacijskega vraničnega prisada (najresnejše oblike vraničnega prisada, pridobljene z vdihavanjem spor bakterij);
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Solithromycin Triskel EU Services did not outweigh its risks.
Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Solithromycin Triskel EU Services ne odtehtajo z njim povezanih tveganj.
Based on the review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that Solithromycin Triskel EU Services could not have been approved for the treatment of community-acquired pneumonia, inhaled anthrax and inhaled tularaemia.
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Solithromycin Triskel EU Services ni mogoče odobriti za zdravljenje zunajbolnišnične pljučnice, inhalacijskega vraničnega prisada in inhalacijske tularemije.
How does Solithromycin Triskel EU Services work?
Kako zdravilo Solithromycin Triskel EU Services deluje?
What is Solithromycin Triskel EU Services?
Kaj je zdravilo Solithromycin Triskel EU Services?
What was Solithromycin Triskel EU Services expected to be used for?
Za kaj naj bi se zdravilo Solithromycin Triskel EU Services uporabljalo?
• development of 1 or more symptom from at least 2 of the following groups:
• enega ali več simptomov iz vsaj DVEH od naslednjih skupin:
• if they drink alcohol
• če uživajo alkohol