natgillin/translations-raw huggingface dataset:
Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Valsartan je „antagonist receptorja za angiotenzin II“, kar pomeni, da zavira delovanje telesnega hormona, imenovanega angiotenzin II.
It is recommended that the patient takes amlodipine and valsartan as separate tablets or capsules before switching to the combination tablet.
Priporočljivo je, da bolnik že jemlje amlodipin in valsartan kot ločene tablete ali kapsule, preden preide na kombinirane tablete.
The full EPAR for Amlodipine/Valsartan Mylan 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 Amlodipin/Valsartan Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The strength of the tablet to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Jakost tablete, ki jo je treba vzeti, je odvisna od odmerkov amlodipina ali valsartana, ki jih je bolnik jemal prej.
This is a summary of the European public assessment report (EPAR) for Amlodipine/Valsartan Mylan.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Amlodipin/Valsartan Mylan.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Amlodipine/Valsartan Mylan has been shown to have comparable quality and to be bioequivalent/be comparable to Exforge.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Amlodipin/Valsartan Mylan primerljivo raven kakovosti kot zdravilo Exforge ter da mu je biološko enakovredno/je z njim primerljivo.
Amlodipine/Valsartan Mylan is a medicine used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Zdravilo Amlodipin/Valsartan Mylan se uporablja pri bolnikih, ki imajo esencialno hipertenzijo (visok krvni tlak), ki je ni mogoče ustrezno uravnati samo z amlodipinom ali valsartanom.
Because Amlodipine/Valsartan 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.
Ker je zdravilo Amlodipin/Valsartan Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The Committee recommended that Amlodipine/Valsartan Mylan be approved for use in the EU.
Priporočil je, da se zdravilo Amlodipin/Valsartan Mylan odobri za uporabo v EU.
They work in similar ways to reduce blood pressure by allowing the blood vessels to relax.
Obe podobno znižujeta krvni tlak, in sicer tako, da spodbujata sprostitev krvnih žil.
For more information about treatment with Amlodipine/Valsartan Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Amlodipin/Valsartan Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What measures are being taken to ensure the safe and effective use of Amlodipine/Valsartan Mylan?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Amlodipin/Valsartan Mylan?
For practical information about using Amlodipine/Valsartan Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Amlodipin/Valsartan Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
When calcium enters the cells in the muscles of blood vessel walls, this causes contraction.
Ko kalcij vstopi v celice mišic v stenah žil, se te začnejo krčiti.
Because Amlodipine/Valsartan Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exforge.
Ker je zdravilo Amlodipin/Valsartan Mylan generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Exforge.
A risk management plan has been developed to ensure that Amlodipine/Valsartan Mylan is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Amlodipin/Valsartan Mylan je bil pripravljen načrt obvladovanja tveganj.
Therefore, the CHMP's view was that, as for Exforge, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Exforge odtehtajo znana tveganja.
By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.
Amlodipin z zmanjšanjem pretoka kalcija v celice prepreči njihovo krčenje in pomaga pri sproščanju sten žil.
Other information about Amlodipine/Valsartan Mylan
Druge informacije o zdravilu Amlodipin/Valsartan Mylan
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Amlodipine/Valsartan Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What are the benefits and risks of Amlodipine/Valsartan Mylan?
Kakšne so koristi in tveganja, povezani z zdravilom Amlodipin/Valsartan Mylan?
This means that Amlodipine/Valsartan Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exforge.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Exforge.
Amlodipine/Valsartan Mylan contains two active substances, amlodipine and valsartan.
Zdravilo Amlodipin/Valsartan Mylan vsebuje dve učinkovini, amlodipin in valsartan.
What is Amlodipine/Valsartan Mylan and what is it used for?
Kaj je zdravilo Amlodipin/Valsartan Mylan in za kaj se uporablja?
Why is Amlodipine/Valsartan Mylan approved?
Zakaj je bilo zdravilo Amlodipin/Valsartan Mylan odobreno?
How is Amlodipine/Valsartan Mylan used?
Kako se zdravilo Amlodipin/Valsartan Mylan uporablja?
How has Amlodipine/Valsartan Mylan been studied?
Kako je bilo zdravilo Amlodipin/Valsartan Mylan raziskano?
How does Amlodipine/Valsartan Mylan work?
Kako zdravilo Amlodipin/Valsartan Mylan deluje?
This overview was last updated in February 2019.
Povzetek je bil nazadnje posodobljen februarja 2019.
Horses were examined at days 14, 35 and 63.
Konje so pregledali na 14., 35. in 63. dan.
Substantial improvement occurs in the next 48 hours with complete resolution in the following two weeks.
V naslednjih 48 urah se je pokazalo pomembno izboljšanje, v naslednjih dveh tednih pa popolna remisija.
Further information on HorStem can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/horstem.
Nadaljnje informacije o zdravilu HorStem so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/horstem.
Stem cells can develop into other types of cells.
Matične celice se lahko razvijejo v druge vrste celic.
Other information about HorStem
Druge informacije o zdravilu HorStem
The European Medicines Agency decided that HorStem'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 zdravila HorStem večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
In case of severe inflammation, treatment with an anti-inflammatory medicine (NSAID) might be necessary.
V primeru hudega vnetja je morda potrebno zdravljenje z nesteroidnimi protivnetnimi zdravili (NSAID).
Hands should be washed after handling the medicine.
Po rokovanju z zdravilom si je treba umiti roke.
Mesenchymal stem cells can have effects on the immune system as well as anti-inflammatory effects and can possess tissue regenerative properties.
Mezenhimske matične celice lahko vplivajo na imunski sistem in imajo protivnetne učinke; poleg tega imajo lahko regenerativne lastnosti na tkiva.
HorStem received a marketing authorisation valid throughout the EU on 19 June 2019.
Zdravilo HorStem je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 19/06/2019.
Why is HorStem authorised in the EU?
Zakaj je zdravilo HorStem odobreno v EU?
What benefits of HorStem have been shown in studies?
Kakšne koristi je zdravilo HorStem izkazalo v študijah?
These are stem cells taken from the umbilical cord of donor horses when a foal is born and grown in a laboratory to increase their numbers.
To so matične celice, ki so bile odvzete iz popkovnice konjev darovalcev in gojene v laboratoriju, da se poveča njihovo število.
Twelve HorStem treated horses were successfully treated (success rate 75%) at day 63 compared to only 4 of the control group (success rate 25%).
Dvanajst konjev, zdravljenih z zdravilom HorStem, je bilo uspešno pozdravljenih (75-odstotna stopnja uspešnosti) na 63. dan v primerjavi s samo štirimi konji v kontrolni skupini (25-odstotna stopnja uspešnosti).
What are the risks associated with HorStem?
Kakšna tveganja so povezana z zdravilom HorStem?
An overview of HorStem and why it is authorised in the EU
Pregled zdravila HorStem in zakaj je odobreno v EU
What is HorStem and what is it used for?
Kaj je zdravilo HorStem in za kaj se uporablja?
These properties are expected to play a role in the effect of HorStem.
Te lastnosti naj bi imele vlogo pri učinkovanju zdravila HorStem.
For more information about using HorStem, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila HorStem glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
Treatment success was a reduction in lameness to a grade of 1 or less, using an accepted scale for equine lameness measurement (scale from 0 to 5, where 0 is nonlame, and 5 is severely lame).
Uspeh zdravljenja je bil zmanjšanje šepavosti do stopnje 1 ali manj po odobreni lestvici za merjenje šepavosti konjev (lestvica od 0 do 5, pri čemer je stopnja 0 pomenila brez šepavosti, stopnja 5 pa huda šepavost).
The withdrawal period for meat from horses treated with HorStem is ‘zero' days, which means that there is no mandatory waiting time.
Karenca za meso konjev, zdravljenih z zdravilom HorStem, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
The most common side effect with HorStem (which may affect more than 1 in 10 horses) is short-lived synovitis (inflammation of the joint lining) with severe lameness, joint effusion (increased fluid in the joint) and pain on palpation 24 hours after injection.
Najpogostejši neželeni učinki zdravila HorStem (ki lahko prizadenejo več kot 1 konja od 10) so akutni sinovitis (vnetje sklepne ovojnice) s hudo šepavostjo, efuzija sklepa (povečana količina tekočine v sklepu) in bolečina ob palpaciji v 24 urah po injiciranju.
It is not clear exactly how HorStem works in horses with osteoarthritis.
Natančen način delovanja zdravila HorStem pri konjih z osteoartritisom ni znan.
HorStem is given only by a veterinarian as a single injection into the affected joint.
Zdravilo HorStem mora dati izključno veterinar v obliki enkratne injekcije v prizadeti sklep.
In a field study of horses with mild to moderate osteoarthritis, 16 horses received an injection of HorStem into the affected joint and 17 horses received a placebo (dummy) injection.
V terenski študiji s konji z blagim do zmernim osteoartritisom je 16 konjev prejelo injekcijo zdravila HorStem v prizadeti sklep, 17 konjev pa je prejelo placebo injekcijo (injekcijo brez učinkovine).
In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
HorStem is a veterinary medicine used to treat lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.
HorStem je zdravilo za uporabo v veterinarski medicini, ki se uporablja za zdravljenje šepavosti, povezane z blago do zmerno degenerativno boleznijo sklepov (osteoartritisom) pri konjih.
Care should be taken to avoid accidental self-injection.
Da bi se izognili samoinjiciranju, je potrebna previdnost.
It contains the active substance equine umbilical cord mesenchymal stem cells.
Vsebuje učinkovino konjskih popkovničnih mezenhimskih matičnih celic.
How does HorStem work?
Kako zdravilo HorStem deluje?
HorStem (equine umbilical cord mesenchymal stem cells)
HorStem (konjske popkovnične mezenhimske matične celice)
How is HorStem used?
Kako se zdravilo HorStem uporablja?
This summary was last updated in 05-2016.
Povzetek je bil nazadnje posodobljen 05-2016.
These materials have been inactivated where necessary so that they do not cause any disease.
Ta material je bil po potrebi inaktiviran, tako da ne povzroča bolezni.
Although no data are available in children older than 2 years, there is no indication that older children would respond differently.
Čeprav za otroke, starejše od dveh let, ni podatkov, prav tako ni znamenj, ki bi kazala, da bi se starejši otroci odzvali drugače.
The European Commission granted a marketing authorisation valid throughout the European Union for Hexacima on 17 April 2013.
Evropska komisija je dovoljenje za promet z zdravilom Hexacima, veljavno po vsej Evropski uniji, izdala 17. aprila 2013.
Vaccination with Hexacima should be carried out according to official recommendations.
Cepljenje s cepivom Hexacima je treba izvajati v skladu z uradnimi priporočili.
Reactions may be more likely after the first dose than later doses.
Reakcije so bolj verjetne po prvem odmerku kot pri naslednjih.
What measures are being taken to ensure the safe and effective use of Hexacima?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hexacima?
Other information about Hexacima
Druge informacije o zdravilu Hexacima
The full EPAR for Hexacima 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 Hexacima je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is used in babies and toddlers aged from six weeks to protect against the following infectious diseases:
Uporablja se pri dojenčkih in otrocih, starejših od šest mesecev, za zaščito proti naslednjim nalezljivim boleznim:
This means that some of the active substances are fixed onto aluminium compounds, to stimulate a better response.
To pomeni, da so nekatere zdravilne učinkovine vezane na aluminijeve spojine, kar spodbudi boljši odziv.
The two-dose vaccination schedule was investigated in an additional main study involving 554 children.
Shema cepljenja z dvema odmerkoma je bila raziskana v dodatni glavni študiji s 554 otroki.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hexacima's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Hexacima večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani proti boleznim.
This is a summary of the European public assessment report (EPAR) for Hexacima.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Hexacima.
The main measure of effectiveness was the production of antibody levels known to be protective against those diseases.
Glavno merilo učinkovitosti je bila tvorba ravni protiteles, za katere je znano, da ščitijo pred temi boleznimi.
The effects were compared with a combination of separate vaccines designed to protect against the diseases included in Hexacima.
Učinke so primerjali s kombinacijo ločenih cepiv, namenjenih za zaščito pred boleznimi, ki so vključene v cepivo Hexacima.
• invasive diseases (such as meningitis) caused by H. influenzae type b bacteria.
• invazivnim boleznim (kot je meningitis), ki jih povzročajo bakterije H. influenzae tipa b.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hexacima have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo cepiva, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
• hepatitis B (a viral liver infection);
• hepatitisu B (virusni okužbi jeter);
It is not intended to provide practical advice on how to use Hexacima.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Hexacima is a vaccine.
Zdravilo Hexacima je cepivo.
It must not be used in children who have an uncontrolled or severe illness affecting the brain or nervous system, such as uncontrolled epilepsy, unless the condition has stabilised with treatment and the benefit clearly outweighs the risk.
Ne sme se uporabljati pri otrocih, ki imajo nenadzorovana ali resna obolenja možganov ali živčnega sistema, kot je nenadzorovana epilepsija, razen če se je stanje z zdravljenjem ustalilo in so koristi cepljenja veliko večje od tveganj.
Regarding safety, the CHMP considered that Hexacima's overall safety profile is similar to other vaccines, although Hexacima is more likely than similar vaccines to cause reactions (mainly at the injection site).
Kar zadeva varnost, je CHMP mnenja, da je celotni varnostni profil cepiva Hexacima podoben drugim cepivom, čeprav je bolj verjetno, da bo cepivo Hexacima povzročilo reakcije (večinoma na mestu injiciranja), kot druga cepiva.
Hexacima contains small amounts of materials derived from the bacteria and viruses it protects against.
Zdravilo Hexacima vsebuje majhne količine materiala, pridobljenega iz bakterij in virusov, proti katerim ščiti.
A booster dose should be given at least six months after the last of these initial doses.
Obnovitveni odmerek je treba dati vsaj šest mesecev po zadnjem od začetnih odmerkov.
What are the risks associated with Hexacima?
Kakšna tveganja so povezana z zdravilom Hexacima?
What benefits of Hexacima have been shown in studies?
Kakšne koristi je zdravilo Hexacima izkazalo v študijah?
The recommended initial vaccination schedule is either two doses, given two months apart or three doses, given at least one month apart.
Priporočeni začetni režim cepljenja je bodisi dva odmerka v razmiku dveh mesecev ali trije odmerki v razmiku vsaj enega meseca.
• diphtheria (a highly contagious disease that affects the throat and skin, and can cause damage to the heart and other organs);
• davici (zelo nalezljivi bolezni, ki prizadene grlo in kožo in lahko poškoduje srce in druge organe);
For more information about treatment with Hexacima, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Hexacima preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is Hexacima and what is it used for?
Kaj je zdravilo Hexacima in za kaj se uporablja?
Five of these studies examined the effect of giving a booster dose at least 6 months after the initial vaccination schedule in 1,511 children.
V petih od teh študij so proučevali učinke obnovitvenega odmerka, ki ga je 1 511 otrok prejelo vsaj šest mesecev po začetni shemi cepljenja.
Hexacima has been studied in several countries worldwide in 12 main studies involving over 3,400 children between six weeks and two years of age who were given three doses of the vaccine during their first six months of life according to different local vaccination schedules.
Cepivo Hexacima je bilo proučevano v različnih državah sveta v 12 glavnih študijah, ki so vključevale več kot 3 400 otrok, starih od šest tednov do dveh let, in ki so v skladu z različnimi lokalnimi shemami cepljenja prejeli tri odmerke cepiva v prvih šestih mesecih življenja.
Hexacima must not be used in children who have ever had an allergic reaction to Hexacima or a vaccine containing the same components, including substances used during the manufacture of the vaccine and which may be found at extremely low levels (such as the antibiotics neomycin or streptomycin).
Cepivo Hexacima se ne sme uporabljati pri otrocih, ki so v preteklosti imeli alergijsko reakcijo nanj ali cepivo, ki vsebuje enake sestavine, vključno s snovmi, ki se uporabljajo med procesom izdelave cepiva in ki so lahko prisotne v zelo majhnih količinah (kot sta antibiotika neomicin ali streptomicin).
Why is Hexacima approved?
Zakaj je bilo zdravilo Hexacima odobreno?
For practical information about using Hexacima, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Hexacima naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The most common side effects with Hexacima include pain and redness at the site of injection, irritability and crying.
Najpogostejši neželeni učinki cepiva Hexacima vključujejo bolečino in rdečico na mestu injiciranja, razdražljivost in jok.
Vaccination with Hexacima should be postponed if a child has a moderate to severe fever.
Cepljenje s cepivom Hexacima je treba odložiti, če ima otrok srednje ali zelo povišano telesno temperaturo.
It must not be used in children who have ever had encephalopathy (a brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components in the past.
Ne sme se uporabljati pri otrocih, ki so v preteklosti preboleli encefalopatijo (obolenje možganov) neznanega vzroka v sedmih dneh po prejemu cepiva, ki je vsebovalo komponente oslovskega kašlja.
Hexacima or an appropriate combination of other vaccines can be used for the booster dose.
Za poživitveni odmerek se lahko uporabi cepivo Hexacima ali ustrezna kombinacija drugih cepiv.
When a child is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them.
Ko otrok prejme cepivo, imunski sistem prepozna dele bakterij in virusov kot tujek in proti njim razvije protitelesa.
• tetanus (lockjaw, usually caused by infection of a wound);
• tetanusu (mrtvičnemu krču, ki ga navadno povzroči okužba rane);
Hexacima is available as a suspension for injection in vials and prefilled syringes.
Cepivo Hexacima je na voljo kot suspenzija za injiciranje v vialah in napolnjenih injekcijskih brizgah.
• poliomyelitis (polio, a disease that affects the nerves and can lead to muscle weakness or paralysis);
• otroški paralizi (bolezni, ki prizadene živce in lahko povzroči oslabelost mišic ali paralizo;
The studies showed that protective antibody levels against the various diseases developed in between 90 and 100% of children after the first three doses of Hexacima; protection was maintained or improved when a booster dose was given.
Študije so pokazale, da so se zaščitne ravni protiteles, ki ščitijo pred različnimi boleznimi, razvile pri 90 do 100 % otrok po prvih treh odmerkih cepiva Hexacima.
For the full list of all side effects reported with Hexacima, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Hexacima, glejte navodilo za uporabo.
These studies showed that Hexacima produces similar antibody profiles over time to comparable vaccines, and that the vaccine can be given at the same time as Prevenar and Rotarix.
Te študije so pokazale, da so po določenem času profili protiteles, ustvarjeni s cepivom Hexacima, podobni tistim, ki jih ustvarijo primerjalna cepiva, in da se sme cepivo uporabljati sočasno s cepivoma Prevenar in Roatrix.