natgillin/translations-raw huggingface dataset:
• Sterile techniques, including periocular and ocular disinfection, to minimise risk of infection
• sterilne tehnike, vključno z razkuževanjem očesa in kože okrog njega, za zmanjševanje tveganja za okužbo,
• Key signs and symptoms of serious adverse events
• ključni znaki in simptomi resnih neželenih dogodkov,
• How to prepare for Lucentis treatment
• kako se pripraviti na zdravljenje z zdravilom Lucentis,
The physician information should contain the following key elements:
Podatki za zdravnika morajo vsebovati sledeče ključne vsebine:
• Use of povidone iodine or equivalent
• uporabo povidon jodida ali drugega ustreznega sredstva,
• What are the steps following treatment with Lucentis
• kaj sledi zdravljenju z zdravilom Lucentis,
The patient information pack should be provided in the form of both patient information booklets and audio-CD that contain following key elements:
Komplet podatkov za bolnika mora vsebovati tako brošure kot zvočno zgoščenko, ki vsebujejo sledeče ključne vsebine:
The physician information pack should contain the following:
Komplet podatkov za zdravnika mora vsebovati sledeče:
• Physician information
• podatke za zdravnika
• Intravitreal injection procedure video
• videoposnetek postopka intravitrealnega injiciranja
• Key signs and symptoms of IVT injection related adverse events
• ključne znake in simptome neželenih dogodkov v zvezi z intravitrealnim injiciranjem,
• Patient information leaflet
• komplete podatkov za bolnika
• Techniques for the intravitreal injection
• tehniko intravitrealnega injiciranja,
• Management of IVT injection related adverse events
• ukrepe v primerih neželenih dogodkov v zvezi z intravitrealnim injiciranjem.
A similar difference was seen between the two groups after two years.
Podobna razlika je bila med tema dvema skupinama ugotovljena po dveh letih.
Patients were followed up for at least two years.
Bolnike so spremljali najmanj dve leti.
The European Commission granted a marketing authorisation valid throughout the European Union for PhotoBarr on 25 March 2004.
Evropska komisija je dovoljenje za promet z zdravilom PhotoBarr, veljavno po vsej Evropski uniji, odobrila dne 25. marca 2004.
This will ensure that all doctors and pharmacists who will prescribe or dispense the medicine are provided with information packs for healthcare workers and patients.
Tako bodo vsi zdravniki in farmacevti, ki bodo predpisovali ali izdajali zdravilo, prejeli informativne pakete za zdravstvene delavce in bolnike.
This kills the cells by reacting with and destroying their components, such as their proteins and DNA.
Ta uniči celice tako, da reagira z njihovimi komponentami, na primer z njihovimi beljakovinami in DNK, ter jih uniči.
The company that makes PhotoBarr is preparing educational materials in agreement with medicines regulatory authorities in Member States.
Družba, ki izdeluje zdravilo PhotoBarr, v soglasju z zdravstvenimi regulativnimi organi držav članic pripravlja izobraževalno gradivo.
What measures are being taken to ensure the safe use of PhotoBarr?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila PhotoBarr?
This is a summary of the European public assessment report (EPAR) for PhotoBarr.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo PhotoBarr.
When it is illuminated with laser light of a specific wavelength, it is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen called ‘singlet oxygen'.
Ko ga osvetlimo z lasersko svetlobo določene valovne dolžine, se porfimer aktivira in reagira s kisikom v celicah, pri čemer se tvori zelo reaktivna in strupena oblika kisika, imenovana singletni kisik.
PhotoBarr porfimer sodium
PhotoBarr porfimer-natrij
Patients who receive PhotoBarr must be given a special card that summarises the safety information on the medicine.
Bolniki, ki se zdravijo z zdravilom Photobarr, morajo dobiti posebno opozorilno kartico, na kateri so povzeti podatki o varnosti zdravila.
The main measure of effectiveness was the number of patients who had no high-grade dysplasia left at least six months after the first course of treatment.
Glavno merilo učinkovitosti je bil delež bolnikov, ki vsaj šest mesecev po prvi epizodi zdravljenja niso imeli displazije visoke stopnje.
By restricting the illumination to the area of dysplasia, only cells in this area are damaged, leaving other areas of the body unaffected.
Če osvetlitev omejimo samo na območje displazije, se poškodujejo samo celice v tem predelu, drugi predeli telesa pa ostanejo nepoškodovani.
The type of apparatus used, as well as the duration of the illumination, depends on how large the disease area is.
Vrsta uporabljenega aparata in trajanje osvetljevanja sta odvisna od velikosti obolelega predela.
The summary of the opinion of the Committee for Orphan Medicinal Products for PhotoBarr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu PhotoBarr je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The packs will include information on PhotoBarr and how it should be used safely.
Paketi bodo vsebovali informacije o zdravilu PhotoBarr ter o njegovi varni uporabi.
PhotoBarr has been studied in one main study involving 208 patients who had Barrett's oesophagus with high-grade dysplasia.
Zdravilo PhotoBarr so proučevali v eni glavni študiji, ki je vključevala 208 bolnikov z Barrettovim požiralnikom z visoko stopnjo displazije.
For more information about treatment with PhotoBarr, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom PhotoBarr preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Other information about PhotoBarr
Druge informacije o zdravilu PhotoBarr:
When PhotoBarr is injected, porfimer is absorbed into cells throughout the body.
Ko zdravilo PhotoBarr injiciramo, se porfimer absorbira v celice po vsem telesu.
If necessary, patients may receive a second, shorter laser treatment two to three days later.
Po potrebi se lahko dva do tri dni kasneje pri bolnikih izvede še drugi, krajši laserski poseg.
After six months, 72% of the patients using PhotoBarr in combination with omeprazole had no high-grade dysplasia left, compared with 31% of those taking omeprazole alone.
Po šestih mesecih 72 % bolnikov, ki so uporabljali zdravilo PhotoBarr v kombinaciji z omeprazolom, ni imelo displazije visoke stopnje, v primerjavi z 31 % bolnikov, ki so jemali samo omeprazol.
What benefit has PhotoBarr shown during the studies?
Kakšne koristi je zdravilo PhotoBarr izkazalo med študijami?
Because the number of patients with Barrett's oesophagus is low, the disease is considered ‘rare', and PhotoBarr was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 March 2002.
Ker je število bolnikov z Barrettovim požiralnikom majhno, velja ta bolezen za redko, zato je bilo zdravilo PhotoBarr dne 6. marca 2002 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
As all patients receiving PhotoBarr become more sensitive to light, they should take care to avoid exposure of their skin and eyes to bright light for at least three months after injection.
Ker postanejo vsi bolniki, ki prejmejo zdravilo PhotoBarr, občutljivejši na svetlobo, kože in oči vsaj tri mesece po injekciji ne smejo izpostavljati močni svetlobi.
Up to two additional treatment courses (one injection and one or two laser treatments) can be given, separated by at least three months, as long as the risk of narrowing of the gullet is taken into account.
Možna sta največ dva dodatna cikla zdravljenja (ena injekcija in en do dva laserska posega) v razmaku najmanj treh mesecev, če je bilo upoštevano tveganje za zoženje požiralnika.
Around two days later, the dysplasia, plus small areas of normal tissue above and below it, is illuminated with light from a laser at a specific wavelength using a fibre optic cable through an endoscope.
Približno dva dni pozneje je treba displazijo in majhne dele normalnega tkiva nad in pod njo osvetljevati z lasersko svetlobo z določeno valovno dolžino s pomočjo kabla iz optičnih vlaken, ki je napeljan skozi endoskop.
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 PhotoBarr.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo PhotoBarr, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Because it causes difficulty swallowing, including pain, nausea and vomiting, patients should only take liquid food for a few days after laser treatment, and for up to four weeks in some cases.
Ker zdravljenje povzroča težave pri požiranju, vključno z bolečino, slabostjo in bruhanjem, naj bolniki nekaj dni po laserskem posegu, v nekaterih primerih pa do štiri tedne po laserskem posegu, uživajo samo tekočo hrano.
It contains the active substance porfimer sodium.
Vsebuje zdravilno učinkovino porfimer-natrij.
The full EPAR for PhotoBarr 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 PhotoBarr je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What is the risk associated with PhotoBarr?
Kakšna tveganja so povezana z zdravilom PhotoBarr?
The CHMP decided that PhotoBarr's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila PhotoBarr večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
PhotoBarr should not be used in people who may be hypersensitive (allergic) to porfimer sodium and other porphyrins, or to any of the other ingredients.
Zdravila PhotoBarr ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) porfimer-natrij in druge porfirine ali katero koli drugo sestavino zdravila.
The most common side effects with PhotoBarr (seen in more than 1 patient in 10) are dehydration, oesophageal stenosis (narrowing of the oesophagus), vomiting, dysphagia (difficulty swallowing), constipation, nausea (feeling sick), photosensitivity reactions (sunburn-like reactions) and pyrexia (fever).
Najpogostejši neželeni učinki zdravila PhotoBarr (opaženi pri več kot 1 bolniku od 10) so dehidracija, ezofagealna stenoza (zoženje požiralnika), bruhanje, disfagija (težave pri požiranju), zaprtje, navzeja (slabost), preobčutljivostne reakcije na svetlobo (reakcije, podobne sončnim opeklinam) in pireksija (povišana telesna temperatura).
Photodynamic therapy with PhotoBarr should only be carried out or supervised by a doctor who has experience in laser treatment using an endoscope (a thin tube used to look into the body) and who has been trained in photodynamic therapy.
Fotodinamično zdravljenje z zdravilom PhotoBarr lahko izvaja ali nadzoruje samo zdravnik, ki ima izkušnje z laserskim zdravljenjem z endoskopom (ozko cevko, ki omogoča preiskavo notranjosti telesa) in je bil usposobljen za fotodinamično zdravljenje.
PhotoBarr is a powder that is made up into a solution for injection.
Zdravilo PhotoBarr je prašek za pripravo raztopine za injiciranje.
PhotoBarr should also only be used if experienced staff and material for assessing and treating anaphylaxis (severe allergic reaction) are immediately available.
Zdravilo PhotoBarr se lahko uporablja samo, če je na voljo izkušeno osebje ter oprema za ocenjevanje in zdravljenje anafilakse (hude alergijske reakcije).
Why has PhotoBarr been approved?
Zakaj je bilo zdravilo PhotoBarr odobreno?
PhotoBarr must not be used in patients with porphyria (an inability to break down porphyrins), severe problems with the liver or kidneys, varices (swollen veins) in the oesophagus or stomach, large ulcers in the oesophagus, fistulae (abnormal passageways) between the oesophagus and either the trachea (windpipe) or the bronchi (airways in the lungs), or suspected damage to major blood vessels.
Ne smejo ga uporabljati osebe s porfirijo (nezmožnostjo razgradnje porfirinov), hudimi težavami z jetri ali ledvicami, varicami (razširjenimi žilami) požiralnika ali želodca, velikimi razjedami požiralnika, fistulami (nenormalnimi prehodi) med požiralnikom in trahejo (sapnikom) oziroma med požiralnikom in bronhiji (dihalnimi kanali v pljučih) ali sumom na poškodbo velikih krvnih žil.
PhotoBarr is used in photodynamic therapy (treatment using light) for the ablation (destruction) of high-grade dysplasia (abnormal cells at high risk of turning into cancer) in patients with Barrett's oesophagus.
Zdravilo PhotoBarr se uporablja za fotodinamično zdravljenje (zdravljenje z uporabo svetlobe) za odstranjevanje displazije visoke stopnje (nenormalnih celic z visokim tveganjem, da postanejo rakave) pri bolnikih z Barrettovim požiralnikom.
This is a disease where the lining at the lower end of the oesophagus (gullet) has changed because of damage due to acid from the stomach.
Za to bolezen je značilno, da se sluznica na spodnjem koncu požiralnika spremeni zaradi poškodbe, ki jo povzroči kislina iz želodca.
Adding photodynamic therapy using PhotoBarr to omeprazole treatment increased the number of patients whose dysplasia was destroyed.
S kombiniranjem fotodinamičnega zdravljenja z zdravilom PhotoBarr in terapije z omeprazolom se je povečalo število bolnikov, pri katerih je bila displazija odpravljena.
The effects of photodynamic therapy with PhotoBarr, used in combination with omeprazole (an antacid medicine), were compared with those of omeprazole alone.
Učinke fotodinamičnega zdravljenja z zdravilom PhotoBarr, uporabljenim v kombinaciji z omeprazolom (antacidnim zdravilom), so primerjali z učinki omeprazola kot samostojnega zdravila.
The active substance in PhotoBarr, porfimer sodium, is a photosensitising agent (a substance that changes when exposed to light).
Zdravilna učinkovina zdravila PhotoBarr, porfimer-natrij, je na svetlobo občutljiva snov (snov, ki se spremeni, če jo izpostavimo svetlobi).
For a more complete list of the side effects reported with PhotoBarr, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila PhotoBarr, glejte navodilo za uporabo.
How has PhotoBarr been studied?
Kako je bilo zdravilo PhotoBarr raziskano?
Treatment with PhotoBarr is a two-step process: the medicine is given first before it is activated using a laser. PhotoBarr is given by slow, careful injection into a vein at a dose of 2 mg per kilogram body weight over three to five minutes.
Injicira se počasi in previdno v veno v odmerku 2 mg na kilogram telesne mase v treh do petih minutah.
What is PhotoBarr used for?
Za kaj se zdravilo PhotoBarr uporablja?
How is PhotoBarr used?
Kako se zdravilo PhotoBarr uporablja?
What is PhotoBarr?
Kaj je zdravilo PhotoBarr?
How does PhotoBarr work?
Kako zdravilo PhotoBarr deluje?
Use the following formula:
Uporabite naslednjo formulo:
If the existing advice is not considered sufficient a proposal for revised text should be submitted.
Če obstoječi nasvet ne zadošča, je treba predložiti predlog za revidirano besedilo.
In: Association of Exotic Mammal Veterinarians (AEMV) Sessions, Preceedings, 2006
V: Association of Exotic Mammal Veterinarians (AEMV) Sessions, Preceedings, 2006
The results of those studies should be provided to the relevant authorities for assessment not later than 12 months after the Commission Decision on this referral procedure.
Rezultate teh študij je treba predložiti ustreznim organom v oceno, najpozneje 12 mesecev po odločbi Komisije o tem napotitvenem postopku.
20041 Agrate Brianza (MB) ITALY
20041 Agrate Brianza (MB) ITALIJA
During the previous referral procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/037)
V prejšnjem napotitvenem postopku v skladu s 34. členom Direktive 2001/82/EC (EMEA/V/A/037)
These higher values require further consideration as they would lead to higher than target dose.
Te višje vrednosti zahtevajo nadaljnji razmislek, saj pomenijo višji odmerek od ciljnega.
The Committee was also asked to recommend whether the marketing authorisations should be maintained, varied, suspended or withdrawn.
Komisija je prav tako prosila Odbor, naj predlaga, ali naj se dovoljenja za promet s temi zdravili ohranijo, spremenijo, začasno umaknejo ali prekličejo.
Lilly Portugal - Produtos Farmacêuticos, Lda.
Portugalska Lilly Portugal - Produtos Farmacêuticos, Lda.
The condition of the Marketing Authorisations is described in Annex IV.
Pogoj za pridobitev dovoljenja za promet z zdravilom je opisan v Prilogi IV.
Prevention and treatment of respiratory disease
Preprečevanje in zdravljenje bolezni dihal
According to stability results, after 3 months no significant change was observed for appearance and loss on drying.
Glede na rezultate stabilnosti po 3 mesecih ni bilo opaziti pomembne spremembe v videzu in izgube pri sušenju.
National Competent Authorities, coordinated by the Reference Member State as applicable, should ensure that following conditions are fulfilled by the marketing authorisation holders:
Pristojni nacionalni organi, ki jih koordinira referenčna država članica, kot je ustrezno, morajo zagotoviti, da imetniki dovoljenja za promet z zdravilom izpolnjujejo naslednje pogoje:
The marketing authorisation holders were requested to provide the following:
Imetniki dovoljenja za promet so morali zagotoviti naslednje:
The pharmacokinetic parameters confirm the effective dose of tilmicosin.
Farmakokinetični parametri potrjujejo učinkovit odmerek tilmikozina.
The conditioning and pelleting were described.
Postopka kondicioniranja in peletiranja sta bila opisana.
Sick animals hereby consume less, being acceptable at 100 g per day.
Bolne živali zaužijejo manj, in sicer 100 g na dan.
Even though it was confirmed that no overage was used in the formulation, no justification was found for those results and it was considered that the results do not fall into the normal range observed in other feed studies.
Čeprav je bilo potrjeno, da pri sestavi ni bil uporabljen presežek, ni bilo nobene utemeljitve za te rezultate in se je štelo, da rezultati ne spadajo v običajni obseg, opažen v drugih študijah o krmi.
Thus, one rabbit of 1.5 kg can consume in average 180 g of feed per day.
Tako en kunec, ki tehta 1,5 kg, lahko zaužije v povprečju 180 g krme na dan.
This discussion should be supported with the appropriate data, i.e. data confirming the pelleting conditions suitability and demonstrating that these conditions do not affect the shelf-life granted for the medicated feedingstuff (1 month).
Ta razprava bi morala biti podprta z ustreznimi podatki, npr. s podatki, ki potrjujejo ustreznost pogojev peletiranja in dokazujejo, da ti pogoji ne vplivajo na rok uporabnosti, odobren za medicirano krmo (1 mesec).
Homogeneity was demonstrated as the coefficient of variation was less than 5 % in all the cases tested.
Homogenost je bila dokazana, ko je bil koeficient variacije v vseh testiranih primerih manj kot 5
This was further supported considering further data provided in which no such problems were presented thus far with pilot scale batches.
To je bilo še dodatno potrjeno ob upoštevanju dodatnih posredovanih podatkov, v katerih doslej takšne težave pri serijah manjše velikosti niso bile predstavljene.
ELANCO VALQUÍMICA, S.A. Avda.
Španija ELANCO VALQUÍMICA, S.A. Avda.
List of the names, pharmaceutical forms, active substance, strengths of the veterinary medicinal products, animal species, marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, zdravilnih učinkovin, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst ter imetnikov dovoljenja za promet z zdravilom v državah članicah
4.9 Amounts to be administered and administration route:
4.9 Količine za odmerjanje in način uporabe:
In order to obtain a correct dosage the concentration of tilmicosin has to be adjusted accordingly.
Da bi dosegli pravilno odmerjanje, je treba ustrezno prilagoditi koncentracijo tilmikozina.
Regarding the target species feeding behaviour, it is known that rabbits feed frequently (up to 30 times per day of 2-8 g of feed over 4-6 minute periods
Glede prehranjevalnega vedenja ciljne vrste je znano, da se kunci prehranjujejo pogosto (do 30-krat na dan 2-8 g krme v 4-6-minutnih obdobjih
200 Route de Mayenne Zi des Touches 53000 Laval FRANCE
Francija SOGEVAL 200 Route de Mayenne Zi des Touches 53000 Laval
Confirmation should be provided that this requirement will be fulfilled by all of the pack sizes for all the different strengths.
Potrditev, da bo ta zahteva izpolnjena, mora biti zagotovljena za vse velikosti pakiranja in za različne jakosti.
Richter Pharma AG Feldgasse 19
Avstrija Richter Pharma AG Feldgasse 19
“To ensure through dispersion of the product, it should first be mixed with a suitable quantity of feed ingredients (20 - 50 kg) before incorporation into the finished feed.
„Da bi zagotovili temeljito porazdelitev zdravila, ga je treba najprej zmešati z ustrezno količino krmnih sestavin (20-50 kg) in šele nato dodati v končno krmo.
The uptake of medicated feed depends on the clinical condition of the animals.
Izkoristek medicirane krme je odvisen od zdravstvenega stanja živali.
states that the daily dose of the medicated pre-mix must be contained in at least half the daily ration of the animals under treatment.
1, je navedeno, da je treba dnevni odmerek medicirane predmešanice dodati v vsaj polovico dnevnih obrokov živali, ki se zdravijo.
Germany Lilly Deutschland GmbHAbt.
Nemčija Lilly Deutschland GmbHAbt.
This was considered acceptable, as homogeneity of medicated feedingstuffs is reached with low concentrations of medicated pre-mixes.
To se je zdelo sprejemljivo, saj je bila homogenost medicirane krme dosežena z nizkimi koncentracijami mediciranih predmešanic.
The average size of a feed mixer can vary from 3 to 5 tons and complete medicated rabbit feedingstuff is produced in the same size mixers.
Povprečna velikost mešalnika za krmo je lahko od 3 do 5 ton, popolna medicirana krmna mešanica za kunce pa je proizvedena v enako velikih mešalnikih.
Regarding meal feeds, mean content was not in the range of 90-110% of the nominal content (180220 ppm), since concentration values were higher than the expected nominal concentration of 200 ppm ± 10% (values rate between 198.1 - 243.6 ppm).
Glede krmnih obrokov, povprečna vsebnost ni bila v razponu 90-110 % nominalne vsebnosti (180-220 ppm), saj so bile vrednosti koncentracije višje od pričakovane nominalne koncentracije 200 ppm ± 10% (vrednosti so bile med 198,1-243,6 ppm).
D-61352 Bad Homburg GERMANY
D-61352 Bad Homburg NEMČIJA
As outlined in the CVMP's Note for guidance (EMEA/CVMP/080/95) a description should be provided of how the pre-mix is to be incorporated into the feedingstuff.
Kot je navedeno v navodilu Odbora CVMP (EMEA/CVMP/080/95), je treba predpisati, kako naj se predmešanica doda v krmo.
The testing of only one strength was considered valid because the concentration of tilmicosin in the final medicated feeding stuffs would be 200 ppm in all cases, as the homogenicity of the other medicated premixes was sufficiently justified.
Testiranje ene same jakosti je veljavno, ker bi bila koncentracija tilmikozina v končni medicirani krmi v vseh primerih 200 ppm, saj je bila homogenost drugih mediciranih predmešanic dovolj utemeljena.
The incorporation rate of Tilmicosin 40 g pre-mix in the feed would be 5 kg per ton (the requirement of the European Pharmacopoeia monograph on pre-mixes for medicated feedingstuffs for veterinary use).
Stopnja dodajanja za 40-gramsko predmešanico tilmikozina bi bila 5 kg na tono (zahteva v monografiji Evropske farmakopeje za predmešanice za medicirano krmo za veterinarsko uporabo).