FrancophonIA/ELRC3.0 huggingface dataset:
English: How does Ecalta work?
Slovenian: Kako zdravilo Ecalta deluje?
English: How has Ecalta been studied?
Slovenian: Kako je bilo zdravilo Ecalta raziskano?
English: What is Ecalta?
Slovenian: Kaj je zdravilo Ecalta?
English: How is Ecalta used?
Slovenian: Kako se zdravilo Ecalta uporablja?
English: On a regular basis
Slovenian: V rednih časovnih obdobjih
English: At next commercial batch manufacture
Slovenian: Pri izdelavi naslednje komercialne serije
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Ni smiselno.
English: Luxembourg/Luxemburg Zoetis Belgium SA Tél/Tel.
Slovenian: Zoetis Belgium SA Tél/Tel.
English: • OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES The MAH shall complete, within the stated timeframe, the following measures: Description
Slovenian: • OBVEZNOST IZVEDBE UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Imetnik dovoljenja za promet z zdravilom mora v spodaj navedenem časovnem okviru izvesti naslednje ukrepe: Opis
English: Provide stability results for batch 19512 at the end of shelf life
Slovenian: Predložiti rezultate preskušanja stabilnosti za serijo 19512 ob koncu roka uporabnosti
English: Zoetis Polska Sp. z o.o.
Slovenian: Polska Zoetis Polska Sp. z o.o.
English: Inactivated Schmallenberg virus, strain BH80/11-4
Slovenian: Inaktivirani virus Schmallenberg, sev BH80/11-4
English: Intramuscular use (in the neck).
Slovenian: Intramuskularna uporaba (v vrat).
English: Continue to develop a test to quantify saponin in the finished product and provide regular updates on results
Slovenian: Nadaljevati s pripravo testa za kvantitativno določitev saponina v končnem cepivu in redno predložiti podatke o ugotovitvah
English: Provide data to support the effectiveness of the antimicrobial preservative at the end of shelf life
Slovenian: Predložiti podatke o učinkovitosti protimikrobnega konzervansa ob koncu roka uporabnosti
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: - zelo pogosti (pri več kot 1 živali od 10 živali med enim ciklom zdravljenja) - pogosti (pri več kot 1 a manj kot 10 živali od 100 živali) - občasni (pri več kot 1 a manj kot 10 živali od 1.000 živali) - redki (pri več kot 1 a manj kot 10 živali od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: No information is available on the use of the vaccine in seropositive animals including those with maternally-derived antibodies.
Slovenian: Na voljo ni nobenih podatkov o uporabi cepiva pri seropozitivnih živalih vključno z živalmi z maternalnimi protitelesi.
English: Aluminium hydroxide Saponin
Slovenian: Aluminijev hidroksid Saponin
English: Zoetis Portugal, Lda.
Slovenian: Portugal Zoetis Portugal, Lda.
English: Sheep: subcutaneous use.
Slovenian: Ovce: subkutana uporaba.
English: * Below the level of detection by the validated RT-PCR method at 3.6 log10 RNA copies/ml of plasma for cattle and at 3.4 log10 RNA copies/ml of plasma for sheep.
Slovenian: * Pod mejo detekcije z validirano RT-PRC metodo pri 3,6 log10 kopij RNA /ml plazme pri govedu in pri 3,4 log10 kopij RNA /ml plazme pri ovcah.
English: Off-white or pink liquid.
Slovenian: Tekočina umazano bele ali roza barve.
English: To stimulate active immunity against Schmallenberg virus in cattle and sheep.
Slovenian: Za stimulacijo aktivne imunosti proti virusu Schmallenberg pri govedu in ovcah.
English: Zoetis B.V., Podružnica Zagreb za promidžbu
Slovenian: Hrvatska Zoetis B.V., Podružnica Zagreb za promidžbu
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated Schmallenberg virus (RP ≥ 1/dose)
Slovenian: KOLIČINA ZDRAVILNE UČINKOVINE Inaktivirani virus Schmallenberg (RP ≥ 1/odmerek)
English: Zoetis Česká republika, s.r.o.
Slovenian: Česká republika Zoetis Česká republika, s.r.o.
English: Special precautions for use in animals Vaccinate only healthy animals.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Cepite samo zdrave živali.
English: 0.1 mg * Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species
Slovenian: * Relativna potenca (test potence na miših) v primerjavi z referenčnim cepivom, ki je bilo dokazano učinkovito pri ciljnih živalskih vrstah
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/02/2015
Slovenian: Datum pridobitve dovoljenja za promet: 06.02.2015
English: Subcutaneous use (in the axillar region behind the elbow).
Slovenian: Subkutana uporaba (aksilarna regija za komolcem).
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substance:
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Zdravilna učinkovina:
English: Zoetis Italia S.r.l.
Slovenian: Italia Zoetis Italia S.r.l.
English: SC (sheep)
Slovenian: (govedo) s.c. (ovce)
English: Zoetis Spain, S.L.
Slovenian: España Zoetis Spain, S.L.
English: Disposal: read package leaflet.
Slovenian: Odstranjevanje: preberite navodilo za uorabo.
English: Shelf life after first opening the container: use immediately.
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: uporabite takoj.
English: Zoetis Hellas S.A.
Slovenian: Kύπρος Zoetis Hellas S.A.
English: Amount per 1 ml dose (sheep)
Slovenian: Odmerek 1 ml (ovce)
English: ZULVAC SBV is available in a cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine.
Slovenian: ZULVAC SBV je na voljo v kartonski škatli z 1 vialo iz polietilena visoke gostote (HDPE) s klorobutilnim zamaškom in aluminijsko zaporko, ki vsebuje 50 ml cepiva.
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Sodium chloride Water for injections
Slovenian: Kalijev dihidrogenfosfat Natrijev hidrogenfosfat dihidrat Natrijev klorid
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini po
English: Deutschland Zoetis Deutschland GmbH Tel: +49 30 330063 0
Slovenian: Zoetis Deutschland GmbH Tel: +49 30 330063 0
English: Cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine.
Slovenian: Kartonska škatla z 1 vialo iz polietilena visoke gostote (HDPE) s klorobutilnim zamaškom in aluminijsko zaporko, ki vsebuje 50 ml cepiva.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/178/001
Slovenian: EU/2/14/178/001
English: ADVICE ON CORRECT ADMINISTRATION Shake the vial before use.
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Pred uporabo pretresite vialo.
English: Provide batch records for a second batch of finished product manufactured according to the dossier
Slovenian: Predložiti podatke o seriji za naslednjo serijo končnega cepiva, izdelanega v skladu z podatki v dokumentaciji
English: Amount per 2 ml dose (cattle)
Slovenian: Odmerek 2 ml (govedo)
English: Shake the vial before use.
Slovenian: Pred uporabo pretresite vialo.
English: PHARMACEUTICAL FORM Suspension for injection
Slovenian: suspenzija za injiciranje
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Cattle:
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
English: Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 4.9 results in reduction of viraemia* and transplacental infection associated with infection by Schmallenberg virus during the first trimester of pregnancy.
Slovenian: Cepljenju plemenskih ovac pred obrejitvijo v skladu s priporočenim programom cepljenja, opisanem v poglavju 4.9, sledi zmanjšanje viremij* in transplacentarnih okužb, ki so posledica okužbe z virusom Schmallenberg v prvem trimesečju brejosti.
English: Duration of immunity: 6 months after vaccination.
Slovenian: Trajanje imunosti: 6 mesecev po cepljenju.
English: Sheep: Safety data are available to demonstrate the safety of the vaccine when administered to pregnant sheep.
Slovenian: Ovce: Podatki o varnosti ob uporabi cepiva pri brejih ovcah so na voljo.
English: Booster vaccination: administer two doses of 2 ml three weeks apart, every twelve months.
Slovenian: Ponovno cepljenje: dva odmerka po 2 ml v razmiku treh tednov, vsakih 12 mesecev.
English: Onset of immunity: 21 days after vaccination.
Slovenian: Začetek imunosti: 21 dni po cepljenju.
English: Zero days.
Slovenian: Karenca: 0 dni.
English: United Kingdom Zoetis UK Limited Tel: +44 (0) 845 300 8034
Slovenian: Zoetis UK Limited Tel: +44 (0) 845 300 8034
English: In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: Name and address of the manufacturer of the biological active substance and the manufacturer responsible for batch release:
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine in izdelovalca, odgovornega za sproščanje serije:
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: D. DRUGI POGOJI IN ZAHTEVE KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Can be used from 2 months of pregnancy and onwards.
Slovenian: Cepi se lahko od 2. meseca brejosti naprej.
English: Onset of immunity: 14 days after completion of the primary vaccination course.
Slovenian: Začetek imunosti: 14 dni po zaključenem osnovnem programu cepljenja.
English: Camprodon, s/n "la Riba" 17813 Vall de Bianya
Slovenian: 17813 Vall de Bianya Girona
English: Pharmacotherapeutic group: immunologicals for bovidae, inactivated viral vaccines for cattle.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za votloroge (bovidae), inaktivirana virusna cepiva Oznaka ATC vet: QI02AA
English: PACKAGE LEAFLET FOR: ZULVAC SBV suspension for injection for cattle and sheep
Slovenian: NAVODILO ZA UPORABO ZULVAC SBV suspenzija za injiciranje za govedo in ovce
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: Duration of immunity: 12 months after completion of the primary vaccination course.
Slovenian: Trajanje imunosti: 12 mesecev po zaključenem osnovnem programu cepljenja
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZULVAC SBV suspension for injection for cattle and sheep
Slovenian: ZULVAC SBV suspenzija za injiciranje za govedo in ovce
English: Hrvatska
Slovenian: KARENCA
English: For active immunisation of cattle from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus.
Slovenian: Za aktivno imunizacijo goveda, starejšega od 3,5 mesecev, za zmanjšanje viremije* v povezavi z okužbo z virusom Schmallenberg.
English: Booster vaccination: - For non-breeding sheep: administer one dose of 1 ml, every 6 months.
Slovenian: Ponovno cepljenje: - za ovce: - en odmerek po 1 ml, vsakih 6 mesecev.
English: Adjuvants:
Slovenian: Dodatka:
English: Cattle: The safety and efficacy of the vaccine have not been established during pregnancy.
Slovenian: Govedo: Varnosti in učinkovitosti cepiva med brejostjo niso ugotavljali.
English: - For female breeding sheep: administer one dose of 1 ml at least 14 days prior to every breeding.
Slovenian: - za plemenske ovce: en odmerek po 1 ml vsaj 14 dni pred vsakim parjenjem.
English: Shelf life after first opening the immediate packaging: use immediately.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 1 leto Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj
English: For active immunisation of sheep from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus.
Slovenian: Ovce: Za aktivno imunizacijo ovac, starejših od 3,5 mesecev, za zmanjšanje viremije* v povezavi z okužbo z virusom Schmallenberg.
English: België/Belgique/Belgien Zoetis Belgium SA Tél/Tel.
Slovenian: België/Belgique/Belgien
English: Primary vaccination: - For cattle from 3.5 months of age: administer two doses of 2 ml three weeks apart.
Slovenian: - za govedo, starejše od 3,5 mesecev, dva odmerka po 2 ml v razmiku 3 tednov.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: Suomi/Finland Zoetis Finland Oy Puh/Tel: +358 (0)9 4300 40
Slovenian: Zoetis Finland Oy Puh/Tel: +358 (0)9 4300 40
English: Zoetis România S.R.L Tel: +40 21 202 3083
Slovenian: Tel: +40 21 202 3083
English: Local reactions may very commonly appear in the vaccinated animals in the form of small intramuscular granulomas up to 0.7 cm of diameter that resolve in a maximum of 10 days.
Slovenian: Pri govedu se v 48 urah po cepljenju zelo pogosto pojavi prehodno povišanje rektalne temperature, ne več kot za 1,5° C. Zelo pogoste so pri cepljenih živalih lokalne reakcije v obliki majhnih intramuskularnih granulomov, premera do 0,7 cm, ki izginejo v največ 10 dneh.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance:
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Zdravilna učinkovina:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: intramuscular use.
Slovenian: NAČIN IN POT(I) UPORABE
English: Lactation: The safety and the efficacy of the vaccine have not been established during lactation.
Slovenian: Varnosti in učinkovitosti cepiva v obdobju laktacije niso ugotavljali.
English: Pregnancy:
Slovenian: Plodnost:
English: Primary vaccination: - For sheep from 3.5 months of age: administer one dose of 1 ml.
Slovenian: Osnovno cepljenje: - za ovce, starejše od 3,5 mesecev: en odmerek po 1 ml. - za plemenske ovce: en odmerek po 1 ml vsaj 14 dni pred parjenjem.
English: EXPIRY DATE EXP {month/year} Once broached, use immediately.
Slovenian: EXP {mesec/leto}
English: AUTHORISATION
Slovenian: INDIKACIJE
English: Local reactions may very commonly appear in the vaccinated animals in the form of diffuse swellings or subcutaneous granulomas of up to a maximum diameter of 8 cm.
Slovenian: Pri ovcah se v 24 urah po cepljenju zelo pogosto pojavi prehodno povišanje rektalne temperature, ne več kot za 1,5° C. Zelo pogoste so pri cepljenih živalih lokalne reakcije v obliki difuznih oteklin ali subkutanih granulomov, premera do največ 8 cm. Reakcija v obliki difuzne otekline premera manj kot 2 cm lahko traja najmanj 47 dni.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial (50 ml)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Local reactions may very commonly appear in the vaccinated animals in the form of small intramuscular granulomas up to 0.7 cm of diameter, which resolve in a maximum of 10 days.
Slovenian: Pri brejih ovcah se v prvih 4 urah po cepljenju zelo pogosto pojavi prehodno povišanje rektalne temperature, ne več kot za 0,8° C. Zelo pogoste so pri cepljenih živalih lokalne reakcije v obliki difuznih oteklin ali subkutanih granulomov, premera do največ 8 cm. Reakcija v obliki manjšega granuloma, premera manj kot 0,5 cm lahko traja najmanj 97 dni.
English: Cattle: The safety and efficacy of the vaccine has not been established in pregnant cattle.
Slovenian: Varnosti in učinkovitosti cepiva pri plemenskih samcih niso ugotavljali.
English: Further information on Ambrisentan Mylan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ambrisentan-mylan.
Slovenian: Nadaljnje informacije za zdravilo Ambrisentan Mylan so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/ambrisentan-mylan.
English: The ‘class' reflects the severity of the disease: ‘class II' involves slight limitation of physical activity and ‘class III' involves marked limitation of physical activity.
Slovenian: Razred odraža resnost bolezni: razred II pomeni rahlo omejitev telesne zmogljivosti, razred III pa znatno omejitev telesne zmogljivosti.
English: As a result, the amount of oxygen that can get into the blood in the lungs is reduced, making physical activity more difficult.
Slovenian: Posledično se zmanjša količina kisika, ki lahko pride v kri v pljučih, zaradi česar je telesna dejavnost otežena.
English: What measures are being taken to ensure the safe and effective use of Ambrisentan Mylan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ambrisentan Mylan?
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Volibris, and do not need to be repeated for Ambrisentan Mylan.
Slovenian: Študije o koristih in tveganjih učinkovine pri odobrenem načinu uporabe so že bile izvedene z referenčnim zdravilom Volibris, zato jih ni treba ponoviti za zdravilo Ambrisentan Mylan.
English: Ambrisentan Mylan is available as tablets (5 and 10 mg).
Slovenian: Zdravilo Ambrisentan Mylan je na voljo v obliki tablet (5 in 10 mg).
English: Ambrisentan Mylan is used in patients with class II or III disease.
Slovenian: Zdravilo Ambrisentan Mylan se uporablja pri bolnikih z boleznijo razreda II ali III.
English: Because Ambrisentan Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Ambrisentan Mylan generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: As for every medicine, the company provided studies on the quality of Ambrisentan Mylan.
Slovenian: Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Ambrisentan Mylan.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ambrisentan Mylan has been shown to have comparable quality and to be bioequivalent to Volibris.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ambrisentan Mylan primerljivo raven kakovosti in je bioekvivalentno referenčnemu zdravilu Volibris.
English: When taken with ciclosporin (a medicine that reduces the activity of the immune system) the dose of Ambrisentan Mylan should be 5 mg daily and the patient should be closely monitored by their doctor.
Slovenian: Kadar se zdravilo Ambrisentan Mylan jemlje sočasno s ciklosporinom (zdravilom, ki zmanjšuje aktivnost imunskega sistema), mora biti odmerek zdravila 5 mg na dan, bolniki pa morajo biti pod skrbnim nadzorom svojega zdravnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ambrisentan Mylan have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ambrisentan Mylan upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: This means that Ambrisentan Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Volibris.
Slovenian: To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Volibris.
English: The company that markets Ambrisentan Mylan will provide a patient card containing important information on the medicine's side effects and the need to avoid pregnancy during treatment.
Slovenian: Podjetje, ki trži zdravilo Ambrisentan Mylan, bo bolnikom priskrbelo kartico, ki bo vključevala pomembne informacije o neželenih učinkih zdravila in o potrebi po preprečevanju zanositve med zdravljenjem.
English: For more information about using Ambrisentan Mylan, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Ambrisentan Mylan glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: As for all medicines, data on the use of Ambrisentan Mylan are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ambrisentan Mylan stalno spremljajo.
English: Side effects reported with Ambrisentan Mylan are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Ambrisentan Mylan, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: An overview of Ambrisentan Mylan and why it is authorised in the EU
Slovenian: Pregled zdravila Ambrisentan Mylan in zakaj je odobreno v EU
English: What are the benefits and risks of Ambrisentan Mylan?
Slovenian: Kakšne so koristi in tveganja zdravila Ambrisentan Mylan?
English: Other information about Ambrisentan Mylan
Slovenian: Druge informacije o zdravilu Ambrisentan Mylan
English: Why is Ambrisentan Mylan authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Ambrisentan Mylan odobreno v EU?
English: Ambrisentan Mylan is a medicine that is used alone or combined with other medicines to treat adults with pulmonary arterial hypertension (PAH).
Slovenian: Ambrisentan Mylan je zdravilo, ki se uporablja kot samostojno zdravilo ali v kombinaciji z drugimi zdravili za zdravljenje odraslih s pljučno arterijsko hipertenzijo (PAH).
English: Ambrisentan Mylan contains the active substance ambrisentan and is a ‘generic medicine'.
Slovenian: Zdravilo Ambrisentan Mylan vsebuje učinkovino ambrisentan in je „generično zdravilo“.
English: It causes high blood pressure in the vessels taking blood from the heart to the lungs and reduces the
Slovenian: To povzroči zelo visok krvni tlak v žilah, po katerih se kri pretaka iz srca v pljuča, in zmanjšuje pretok krvi v pljuča.
English: What is Ambrisentan Mylan and what is it used for?
Slovenian: Kaj je zdravilo Ambrisentan Mylan in za kaj se uporablja?
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Slovenian: Pljučna arterijska hipertenzija se kaže v neobičajno visokem krvnem tlaku v pljučnih arterijah.
English: By blocking the effect of endothelin, Ambrisentan Mylan prevents the vessels becoming too narrow helping to lower the blood pressure and improving symptoms.
Slovenian: Zdravilo Ambrisentan Mylan z zaviranjem učinka endotelina omogoči širjenje žil, kar prispeva k znižanju krvnega tlaka in olajšanju simptomov.
English: Ambrisentan Mylan can only be obtained with a prescription and treatment must be started by a doctor who has experience in the treatment of PAH.
Slovenian: Predpisovanje in izdaja zdravila Ambrisentan Mylan je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem pljučne arterijske hipertenzije.
English: PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs.
Slovenian: Pljučna arterijska hipertenzija je izčrpavajoča bolezen, pri kateri pride do hude zožitve krvnih žil v pljučih.