natgillin/translations-raw huggingface dataset:
Further information on Vantobra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/vantobra
Dodatne informacije o zdravilu Vantobra so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/vantobra
After a 28-day course of treatment, the patient stops treatment for 28 days, before starting another 28-day course.
Po 28 dneh zdravljenja bolnik to za 28 dni prekine, čemur ponovno sledi 28-dnevno zdravljenje.
The recommended dose is one ampoule twice a day, ideally 12 hours apart.
Priporočeni odmerek je ena ampula dvakrat na dan, najbolje v razmaku 12 ur.
Vantobra is therefore easier to use and might help patients to stick to their treatment.
Zdravilo Vantobra je zato lažje uporabljati in lahko pomaga bolnikom, da se držijo zdravljenja.
The European Medicines Agency decided that Vantobra's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je sklenila, da so koristi zdravila Vantobra večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Treatment courses may be repeated for as long as the doctor considers the patient to be benefiting from treatment.
Cikli zdravljenja se lahko ponavljajo, dokler to bolniku po zdravnikovi presoji koristi.
What measures are being taken to ensure the safe and effective use of Vantobra?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vantobra?
1 Previously known as Tobramycin PARI.
1 Prej znano kot Tobramycin PARI
The Agency noted that safety profile of inhaled tobramycin was well known.
Agencija je ugotovila, da je varnostni profil tobramicina, ki se vdihava, dobro znan.
As for all medicines, data on the use of Vantobra are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Vantobra stalno spremljajo.
However, the following side effects are seen in up to 1 in 100 patients: dyspnoea (difficulty breathing), dysphonia (hoarseness), pharyngitis (sore throat) and cough.
Vendar so bili pri 1 od 100 bolnikov opaženi naslednji neželeni učinki: dispneja (oteženo dihanje), disfonija (hripavost), faringitis (vneto žrelo) in kašelj.
If the patient is also receiving other inhaled treatments or chest physiotherapy, it is recommended that Vantobra is used last.
Če bolnik prejema tudi druga zdravila z inhaliranjem ali fizioterapijo prsnega koša, se priporoča, da se zdravilo Vantobra uporabi nazadnje.
In addition, it takes less time to inhale Vantobra than other tobramycin nebulisers and the time it takes is comparable to the time it takes to inhale the dry powder.
Poleg tega traja manj časa, da se zdravilo Vantobra vdihne, kot pri drugih nebulizatorjih s tobramicinom, čas, ki ga vzame, pa je primerljiv s časom, potrebnim za vdihavanje suhega prahu.
This means that it is similar to a ‘reference medicine' containing the same active substance, tobramycin; however, Vantobra has a higher amount of the active substance.
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isto učinkovino, tobramicin, a vsebuje večjo količino te učinkovine.
Side effects reported with Vantobra are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Vantobra, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
For more information about using Vantobra, see the package leaflet or contact your doctor or pharmacist.
Za več informacij o uporabi zdravila Vantobra glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vantobra have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Vantobra upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Other information about Vantobra
Druge informacije o zdravilu Vantobra
Why is Vantobra authorised in the EU?
Zakaj je bilo zdravilo Vantobra odobreno v EU?
There were no unexpected safety issues with Vantobra.
Pri zdravilu Vantobra ni bilo nepričakovanih varnostnih težav.
In addition, a ‘bioequivalence' study in 58 patients with cystic fibrosis aged 6 years and above determined whether Vantobra produces similar levels of the active substance in the body as the reference medicine, Tobi.
Poleg tega so v študiji bioekvivalence pri 58 bolnikih s cistično fibrozo, starih šest let in več, ugotovljali, ali zdravilo Vantobra proizvede podobne ravni učinkovine v telesu kot referenčno zdravilo Tobi.
What benefits of Vantobra have been shown in studies?
Kakšne koristi je zdravilo Vantobra izkazalo v študijah?
An overview of Vantobra and why it is authorised in the EU
Pregled zdravila Vantobra in zakaj je odobreno v EU
For these patients Vantobra, which is inhaled as a solution from a nebuliser, would be a useful alternative.
Za te bolnike bi bilo zdravilo Vantobra, ki se inhalira kot raztopina iz nebulatorja, koristna druga možnost.
What is Vantobra and what is it used for?
Kaj je zdravilo Vantobra in za kaj se uporablja?
Cystic fibrosis is an inherited disease in which thick mucus builds up in the lungs that allows bacteria to grow more easily, causing infections.
Cistična fibroza je dedna bolezen, pri kateri se v pljučih kopiči gosta sluz, ki omogoča lažjo rast bakterij, kar povzroča okužbe.
The Agency noted that inhaled tobramycin was the ‘gold standard' for treating P. aeruginosa infection in patients with cystic fibrosis and that some patients cannot use the dry powder form because of unacceptable side effects.
Agencija je ugotovila, da je inhaliranje tobramicina „zlati standard“ za zdravljenje okužbe s P. aeruginosa pri bolnikih s cistično fibrozo in da nekateri bolniki zaradi nesprejemljivih neželenih učinkov ne morejo uporabljati suhega prahu.
What are the risks associated with Vantobra?
Kakšna tveganja so povezana z zdravilom Vantobra?
P. aeruginosa is a frequent cause of infections in cystic fibrosis patients.
Bakterija P. aeruginosa je pogosto vzrok za okužbe pri bolnikih s cistično fibrozo.
The active substance in Vantobra, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'.
Zdravilna učinkovina zdravila Vantobra, tobramicin, spada v skupino antibiotikov, imenovano „aminoglikozidi“.
The results of the study showed that Vantobra can be considered comparable to Tobi.
Rezultati študije so pokazali, da je zdravilo Vantobra primerljivo zdravilu Tobi.
Vantobra is a ‘hybrid medicine'.
Zdravilo Vantobra je hibridno zdravilo.
The reference medicine for Vantobra is Tobi.
Referenčno zdravilo za zdravilo Vantobra je zdravilo Tobi.
Vantobra is an antibiotic used for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged six years and older who have cystic fibrosis.
Zdravilo Vantobra je antibiotik, ki se uporablja za zdravljenje dolgotrajne okužbe pljuč z bakterijo Pseudomonas aeruginosa pri bolnikih, starih šest let in več, ki imajo cistično fibrozo.
Tobramycin has been used for several years to treat P. aeruginosa infection in patients with cystic fibrosis and the applicant submitted data from the literature to support the use of Vantobra.
Tobramicin se že več let uporablja za zdravljenje okužbe z bakterijo P. aeruginosa pri bolnikih s cistično fibrozo, zato je vlagatelj predložil podatke iz literature v podporo uporabi zdravila Vantobra.
Vantobra is available as a nebuliser solution in single-dose ‘ampoules'.
Zdravilo Vantobra je na voljo kot raztopina za nebulator v enoodmernih „ampulah“.
Vantobra is inhaled using a device called Tolero nebuliser, which converts the solution in the ampoule into a fine mist.
Zdravilo Vantobra se inhalira s pomočjo nebulatorja Tolero, ki raztopino v ampuli pretvori v fino meglico.
Side effects with Vantobra are not common.
Neželeni učinki zdravila Vantobra niso pogosti.
It works by interfering the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria, which eventually kills them.
Deluje tako, da prekine tvorbo beljakovin, ki jih P. aeruginosa potrebuje za gradnjo celičnih sten.
How does Vantobra work?
Kako zdravilo Vantobra deluje?
How is Vantobra used?
Kako se zdravilo Vantobra uporablja?
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration and marketing authorisation holders in the member states
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
Crossways Business Park Dartford
Crossways Business Park Dartford, Kent
Promixin nasal use
Promixin nazalna uporaba
Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektionsoder Infusionslösung powder for solution for injection/infusion
Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektionsoder Infusionslösung prašek za raztopino za injiciranje/infundiranje
Promixin 1 million international units (IU) powder for solution for infusion powder for solution for injection intramuscular use, intravenous use
Promixin 1 million international units (IU) powder for solution for infusion prašek za raztopino za injiciranje intramuskularna uporaba, intravenska uporaba
Colixin 1 milijun IU prašak za otopinu za injekciju powder for solution for injection
Colixin 1 milijun IU prašak za otopinu za injekciju prašek za raztopino za injiciranje
Tadim 1 Million I.E. Pulver zur Herstellung einer Infusionslösung powder for solution for infusion
Tadim 1 Million I.E. Pulver zur Herstellung einer Infusionslösung prašek za raztopino za infundiranje
COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur powder and solvent for nebuliser solution
COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur prašek in vehikel za inhalacijsko raztopino za nebulator
Powder for solution for injection, infusion or inhalation powder for solution for injection, infusion or inhalation
Powder for solution for injection, infusion or inhalation prašek za raztopino za injiciranje, infundiranje ali inhaliranje
COLIMYCINE 1.000.000 U.I., poudre et solvant pour solution injectable powder and solvent for solution for injection
COLIMYCINE 1.000.000 U.I., poudre et solvant pour solution injectable prašek in vehikel za raztopino za injiciranje
Colistimethate Xellia powder for solution for infusion
Colistimethate Xellia prašek za raztopino za infundiranje
Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador powder for solution for injection, powder for nebuliser solution
Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador prašek za raztopino za injiciranje, prašek za inhalacijsko raztopino za nebulator
Colimycine powder for solution for injection intravenous use, intramuscular use
Colimycine prašek za raztopino za injiciranje intravenska uporaba, intramuskularna uporaba
Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador powder for solution for injection, powder for nebuliser solution
Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador prašek za raztopino za injiciranje, prašek za inhalacijsko raztopino za nebulator
Colistimethate sodium 1 million international units powder for solution for injection or infusion powder for solution for injection/infusion
Colistimethate sodium 1 million international units powder for solution for injection or infusion prašek za raztopino za injiciranje/infundiranje
Pulver zur Herstellung einer Lösung für einer Infusionslösung powder for solution for infusion
Pulver zur Herstellung einer Lösung für einer Infusionslösung prašek za raztopino za infundiranje
Colistin ForestTrockenstechampullen mit Lösungsmittel powder and solvent for suspension for injection, nebuliser solution intramuscular use, intravenous use, inhalation use
Colistin ForestTrockenstechampullen mit Lösungsmittel prašek in vehikel za suspenzijo za injiciranje, inhalacijska raztopina za nebulator intramuskularna uporaba, intravenska uporaba, za inhaliranje
Generis Farmacêutica, S.A. Rua João de Deus 19 2700-487 Amadora Portugal
Portugalska Generis Farmacêutica, S.A. Rua João de Deus 19
Belgium Forest Laboratories UK Ltd. Riverbridge House
Madžarska Forest Laboratories UK Limited Riverbridge House
Pulver zur Herstellung einer Injektions-/Infusionslösung powder for solution for injection/infusion
Pulver zur Herstellung einer Injektions-/Infusionslösung prašek za raztopino za injiciranje/infundiranje
Colomycin Injection 2 million international units powder for soln for inj, infusion or inhalation powder for solution for injection
Colomycin Injection 2 million international units powder for soln for inj, infusion or inhalation prašek za raztopino za injiciranje
powder for solution for injection powder for solution for injection
powder for solution for injection prašek za raztopino za injiciranje
Colomycin Injection 1 million international units powder for soln for inj, infusion or inhalation powder for solution for injection, infusion or inhalation intramuscular use, intravenous use, inhalation use
Colomycin Injection 1 million international units powder for soln for inj, infusion or inhalation prašek za raztopino za injiciranje, infundiranje ali inhaliranje intramuskularna uporaba, intravenska uporaba, za inhaliranje
powder for solution for injection, injection or inhalation intramuscular use, intravenous use, inhalation use
prašek za raztopino za injiciranje, infundiranje ali inhaliranje intramuskularna uporaba, intravenska uporaba, za inhaliranje
Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation powder for solution for injection/infusion/ inhalation
Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation prašek za raztopino za injiciranje/infundiranje /inhaliranje
Colistin Xellia powder for solution for injection/infusion
Colistin Xellia prašek za raztopino za injiciranje/infundiranje
Colistina Generis powder for solution for injection or for nebuliser solution
Colistina Generis prašek za raztopino za injiciranje ali za inhalacijsko raztopino za nebulator
Colistimethate Alvogen powder for solution for injection or infusion
Colistimethate Alvogen prašek za raztopino za injiciranje ali infundiranje
powder for solution for injection intramuscular use
prašek za raztopino za injiciranje intramuskularna uporaba
powder and solvent for solution for injection intramuscular use
prašek in vehikel za raztopino za injiciranje intramuskularna uporaba
Colistin Alvogen powder for solution for injection/infusion
Colistin Alvogen prašek za raztopino za injiciranje/infundiranje
powder for solution for injection/infusion/ inhalation
prašek za raztopino za injiciranje/infundiranje
Colixin powder for solution for injection or for nebuliser solution
Colixin prašek za raztopino za injiciranje ali za inhalacijsko raztopino za nebulator
It is transmitted by mosquitoes and is most common in Asia, particularly in rural areas.
Prenašajo ga komarji, najpogostejši pa je v Aziji, zlasti na podeželskih območjih.
Long-term antibody levels were similar with both schedules.
Dolgoročne ravni protiteles so bile v obeh shemah podobne.
• The third main study involved 1,869 children aged between 2 months and 18 years.
• Tretja glavna študija je vključevala 1 869 otrok, starih od 2 mesecev do 18 let.
This means that the virus is fixed onto aluminium compounds, to stimulate a better response.
To pomeni, da je virus vezan na aluminijeve spojine, kar spodbudi boljši odziv.
They also showed that a booster dose might be needed to maintain high levels of protection, which may be necessary for people at high risk of exposure to the virus.
Pokazale so tudi, da bi obnovitveni odmerek morda bil potreben za ohranitev visoke ravni zaščite, kar je nujno za ljudi, ki bi utegnili biti močno izpostavljeni virusu.
Before vaccination, most of the people in the study had no protective levels of antibodies against the virus.
Pred cepljenjem večina ljudi v študiji ni imela nobenih zaščitnih ravni protiteles proti virusu.
Further information on Ixiaro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ixiaro.
Nadaljnje informacije za cepivo Ixiaro so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Ixiaro.
This was compared with 94% of the people receiving the comparator vaccine (347 out of 370).
To so primerjali s 94 % (347 od 370) oseb, ki so prejele primerjalno cepivo.
Vaccination must be postponed in people with recent severe fever.
Cepljenje je treba pri osebah, ki so nedavno imele močno povišano telesno temperaturo, odložiti.
Ixiaro received a marketing authorisation valid throughout the EU on 31 March 2009.
Za cepivo Ixiaro je bilo 31. marca 2009 izdano dovoljenje za promet, veljavno po vsej EU.
Japanese encephalitis can be fatal or lead to long-term disability.
Japonski encefalitis je lahko smrtno nevaren ali povzroči dolgotrajno invalidnost.
The European Medicines Agency decided that Ixiaro's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi cepiva Ixiaro večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The antibodies will help to protect against the disease.
Ta mu bodo pomagala pri obrambi pred boleznijo.
What measures are being taken to ensure the safe and effective use of Ixiaro?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ixiaro?
When a person is given the vaccine, the immune system identifies the inactivated virus as ‘foreign' and makes antibodies against it.
Ko oseba prejme cepivo, imunski sistem prepozna inaktivirani virus kot „tujek“ in proti njemu začne tvoriti protitelesa.
The Agency noted that the production of the only other vaccine for protection against Japanese encephalitis that was in use outside Asia had been discontinued.
Agencija je upoštevala dejstvo, da je bila proizvodnja edinega drugega cepiva za zaščito pred japonskim encefalitisom, ki se je uporabljalo zunaj Azije, ustavljena.
The 7-day accelerated vaccination course did not produce lower protection than the standard 4-week vaccination course.
Sedemdnevna hitra shema cepljenja ni zagotovila nič kaj manjše zaščite od standardne štiritedenske sheme cepljenja.
The second dose should be given at least one week before potential exposure to the virus.
Cepljenje mora biti zaključeno vsaj en teden pred morebitno izpostavitvijo virusu.
Other information about Ixiaro
Druge informacije o zdravilu Ixiaro
The virus in Ixiaro is grown in mammal cells (‘Vero cells') under laboratory conditions.
Virus v cepivu Ixiaro je vzgojen v celicah sesalcev („celicah Vero“) v laboratorijskih pogojih.
Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed))
Ixiaro (cepivo proti japonskemu encefalitisu (inaktivirano, adsorbirano))
In addition, the company presented the results of studies looking at the level of protection in adults and in children for up to 3 years after vaccination with Ixiaro, and at the response to booster doses.
Poleg tega je podjetje predstavilo rezultate študij, v katerih so proučevali raven zaščite pri odraslih in otrocih do tri leta po cepljenju s cepivom Ixiaro in njihov odziv na obnovitvene odmerke.
Side effects reported with Ixiaro are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri cepivu Ixiaro, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend against a disease.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani pred boleznijo.
A booster dose should also be considered for adults aged above 65 years before any further exposure to the Japanese encephalitis virus.
O obnovitvenem odmerku je treba razmisliti tudi pri odraslih, starejših od 65 let, pred kakršno koli nadaljnjo izpostavljenostjo virusu japonskega encefalitisa.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ixiaro 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 cepiva Ixiaro upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
• The second main study in 660 adults compared a rapid vaccination course (2 doses given 7 days apart) with the standard vaccination course (2 doses given 4 weeks apart).
• V drugi glavni študiji so pri 660 odraslih osebah primerjali hitro shemo cepljenja (dva odmerka v razmiku sedmih dni) z običajno shemo (dva odmerka v razmiku štirih tednov).
Ixiaro must not be used in people who are hypersensitive (allergic) to any residual substances in the vaccine such as protamine sulphate.
Cepivo Ixiaro se ne sme uporabljati pri osebah, ki so preobčutljive za (alergične na) katere koli ostanke v cepivu, kot je npr. protaminijev sulfat.
As for all medicines, data on the use of Ixiaro are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi cepiva Ixiaro stalno spremljajo.
For more information about using Ixiaro, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe cepiva Ixiaro glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Why is Ixiaro authorised in the EU?
Zakaj je zdravilo Ixiaro odobreno v EU?
Children and adolescents may also receive a booster dose one to two years after the initial vaccination.
Tudi otroci in mladostniki lahko prejmejo obnovitveni odmerek eno ali dve leti po osnovnem cepljenju.
Ixiaro is given by injection into a muscle, preferably into the shoulder muscle, or into the thigh muscle in young children.
Cepivo Ixiaro se injicira v mišico, po možnosti v ramensko mišico ali pa v stegensko mišico pri mlajših otrocih.
On average, the levels of antibodies were over 2 times higher in the people receiving Ixiaro than in those receiving the comparator vaccine.
Na splošno so bile ravni protiteles več kot dvakrat višje pri osebah, ki so prejele cepivo Ixiaro, kot pri tistih, ki so prejele primerjalno cepivo.
Vaccination with Ixiaro should be considered for people who are at risk of exposure to the Japanese encephalitis virus through travel or work.
O cepljenju s cepivom Ixiaro je treba razmisliti pri ljudeh, pri katerih obstaja tveganje za izpostavitev virusu japonskega encefalitisa med potovanjem ali opravljanjem službe.
• The first study involved 867 healthy adults and compared Ixiaro with another vaccine for Japanese encephalitis containing viruses grown in mouse brains.
• V prvi študiji, v kateri je sodelovalo 867 zdravih odraslih, so cepivo Ixiaro primerjali z drugim cepivom proti japonskemu encefalitisu, ki je vsebovalo viruse, vzgojene v mišjih možganih.
An overview of Ixiaro and why it is authorised in the EU
Pregled zdravila Ixiaro in zakaj je odobreno v EU
The most common side effects with Ixiaro in adults (which may affect more than 1 in 10 people) are headache, myalgia (muscle pain), pain and tenderness at the injection site and tiredness.
Najpogostejši neželeni učinki cepiva Ixiaro pri odraslih (ki se lahko pojavijo pri več kot 1 osebi od 10) so glavobol, mialgija (bolečine v mišicah), bolečina in občutljivost na mestu injiciranja ter utrujenost.
These additional studies showed that protection against Japanese encephalitis virus lasted for at least 2 to 3 years in most people vaccinated with Ixiaro.
Te dodatne študije so pokazale, da je zaščita proti virusu japonskega encefalitisa pri večini ljudi, cepljenih s cepivom Ixiaro, trajala vsaj dve do tri leta.
What is Ixiaro and what is it used for?
Kaj je zdravilo Ixiaro in za kaj se uporablja?