natgillin/translations-raw huggingface dataset:
The company presented a laboratory study in Beagle dogs comparing treatment with spironolactone and benazepril as single active substances (in the products Prilactone and Fortekor which are already authorised in the EU) to treatment with Cardalis.
Družba je predložila laboratorijsko študijo pri psih pasme beagle, v kateri so primerjali zdravljenje s spironolaktonom in benazeprilom kot edinima zdravilnima učinkovinama (v zdravilih Prilactone oziroma Fortekor, ki že imata dovoljenje za promet z zdravilom v EU) z zdravljenjem z zdravilom Cardalis.
Cardalis is used to treat dogs with congestive heart failure.
Zdravilo Cardalis se uporablja za zdravljenje psov s kongestivnim srčnim popuščanjem.
Cardalis is used for congestive heart failure caused by long-term damage to the heart valves.
Zdravilo Cardalis se uporablja za kongestivno popuščanje srca, ki ga povzroči dolgotrajna poškodba srčnih zaklopk.
Cardalis must not be used in cases of aortic or pulmonary stenosis (narrowing of the aorta or pulmonary blood vessels) affecting the heart's blood output.
Zdravilo Cardalis se ne sme uporabiti v primerih aortne ali pljučne stenoze (zoženja aorte ali pljučnih krvnih žil), ki vpliva na iztis krvi iz srca.
Regular monitoring should continue in dogs with reduced kidney function as they may have an increased risk of hyperkalaemia (raised potassium levels in the blood) during treatment.
Redno nadziranje je treba nadaljevati pri psih z zmanjšanim delovanjem ledvic, saj je pri njih morda tveganje za hiperkaliemijo (zvišano raven kalija v krvi) med zdravljenjem večje.
Cardalis must not be used in dogs with Addison's disease or hypoadrenocorticism (a condition where the adrenal gland does not produce sufficient amounts of hormones), hyperkalaemia (increased blood potassium levels) or hyponatraemia (reduced blood sodium levels).
Zdravilo Cardalis se ne sme uporabljati pri psih z Addisonovo boleznijo ali hipoadrenokorticizmom (stanjem, pri katerem v nadledvični žlezi ne nastaja dovolj hormonov), hiperkaliemijo (zvišano ravnjo kalija v krvi) ali hiponatriemijo (znižano ravnjo natrija v krvi).
These studies demonstrated an increased survival in dogs treated concurrently with spironolactone and benazepril compared to benazepril alone.
Študije so pokazale, da je bilo preživetje psov, ki so bili sočasno zdravljeni s spironolaktonom in benazeprilom, večje v primerjavi s psi, ki so bili zdravljeni samo s benazeprilom.
In case of accidental ingestion, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
V primeru nenamernega zaužitja takoj poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali ovojnino.
Cardalis must not be used in pregnant or lactating (milk producing) bitches as toxic effects for the foetus were seen in studies of benazepril in rats.
Zdravilo Cardalis se ne sme uporabiti pri psicah, ki so breje ali v laktaciji (doječe), saj so v študijah benazeprila pri podganah opazili toksične učinke na zarodke.
Cardalis should be used with caution in dogs with liver damage as this may alter the way spironolactone is metabolised (processed) in the liver.
Zdravilo Cardalis je treba pri psih s poškodovanimi jetri uporabljati previdno, saj lahko spremeni način presnavljanja (obdelave) spironolaktona v jetrih.
Non-castrated male dogs treated with spironolactone may show atrophy (wasting) of the prostrate (a gland of the male reproductive system) that is reversible.
Pri nekastriranih psih, zdravljenih s spironolaktonom, lahko pride do reverzibilne atrofije (izginjanja) prostate (žleze moškega reprodukcijskega sistema).
What is Cardalis used for?
Za kaj se zdravilo Cardalis uporablja?
How has Cardalis been studied?
Kako je bilo zdravilo Cardalis raziskano?
How does Cardalis work?
Kako zdravilo Cardalis deluje?
What is Cardalis?
Kaj je zdravilo Cardalis?
Kidney function and potassium levels in the blood should be monitored before start of treatment in all dogs.
Pred začetkom zdravljenja je treba pri vseh psih nadzirati delovanje ledvic in ravni kalija.
1 See outcome of safety review carried out in 2019.
1Glejte izid varnostnega pregleda, opravljenega v letu 2019.
Further information on Lemtrada can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lemtrada
Nadaljnje informacije o zdravilu Lemtrada so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/lemtrada
What measures are being taken to ensure the safe and effective use of Lemtrada?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lemtrada?
Lemtrada received a marketing authorisation valid throughout the EU on 12 September 2013.
Za zdravilo Lemtrada je bilo 12. septembra 2013 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Lemtrada'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 Lemtrada večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
• disease that is highly active, even though they have been treated with a disease-modifying therapy;
• z zelo aktivno boleznijo, čeprav so bili zdravljeni z zdravilom, ki spreminja potek bolezni;
Other information about Lemtrada
Druge informacije o zdravilu Lemtrada
What benefits of Lemtrada have been shown in studies?
Kakšne koristi zdravila Lemtrada so se pokazale v študijah?
As for all medicines, data on the use of Lemtrada are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Lemtrada stalno spremljajo.
The Agency considered that studies have shown the benefit for patients with highly active disease and rapidly worsening severe disease.
Menila je, da so študije pokazale koristi zdravila za bolnike z zelo aktivno boleznijo in hitro napredujočo hudo obliko bolezni.
The company that markets Lemtrada will carry out studies on the safety of the medicine and to assess whether the medicine is used according to the latest recommendations.
Podjetje, ki trži zdravilo Lemtrada, bo izvedlo študije o varnosti zdravila in ocenilo, ali se zdravilo uporablja v skladu z najnovejšimi priporočili.
‘Relapsing-remitting' means that the patient has attacks (relapses) between periods with few or no symptoms (remissions).
„Recidivnoremitentna“ pomeni, da ima bolnik napade (recidive), ki jim sledijo obdobja z malo ali brez simptomov (remisije).
In both studies, the main measure of effectiveness was based on the number of relapses the patients had each year and the progression of disability after two years of treatment.
V obeh študijah je glavno merilo učinkovitosti temeljilo na številu recidivov, ki jih je bolnik doživel vsako leto, in napredovanju invalidnosti po dveh letih zdravljenja.
Lemtrada is used for patients with:
Zdravilo Lemtrada se uporablja pri bolnikih:
• rapidly worsening, severe disease, who have had 2 or more relapses in one year and whose brain scans show certain brain lesions.
• s hitro napredujočo hudo obliko bolezni, ki se kaže z dvema ali več recidivi v enem letu, pri katerih slikanje možganov pokaže določene lezije na možganih.
CD52 is found on lymphocytes, white blood cells that are part of the immune system.
Beljakovina CD52 je prisotna na limfocitih, belih krvnih celicah, ki so del imunskega sistema.
For more information about using Lemtrada, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Lemtrada glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Lemtrada?
Kakšna tveganja so povezana z zdravilom Lemtrada?
An overview of Lemtrada and why it is authorised in the EU
Pregled zdravila Lemtrada in zakaj je odobreno v EU
Why is Lemtrada authorised in the EU?
Zakaj je zdravilo Lemtrada odobreno v EU?
Over half of patients included in the extension study did not have disease progression and did not need additional Lemtrada infusions.
Pri približno polovici bolnikov, vključenih v podaljšano študijo, bolezen ni napredovala in niso potrebovali dodatnih infuzij zdravila Lemtrada.
The way alemtuzumab acts in multiple sclerosis is not fully understood, but it is believed that its effect on lymphocytes reduces the immune system's damaging activity.
Način delovanja alemtuzumaba pri multipli sklerozi še ni popolnoma pojasnjen, domnevno pa z delovanjem na limfocite zmanjšuje škodljivo delovanje imunskega sistema.
Patients involved in the two main studies were followed-up for at least four years in an extension study, during which they were given up to two additional doses of Lemtrada, at one-year intervals, if their disease progressed.
Bolnike, ki so bili vključeni v obe glavni študiji, so vsaj štiri leta spremljali v podaljšani študiji, med katero so prejeli do dva dodatna odmerka zdravila Lemtrada v enoletnih razmikih, če je bolezen pri njih napredovala.
The company will ensure that doctors expected to prescribe the medicine receive educational materials containing important safety information, and a checklist covering the necessary screening, medicines to reduce side effects, monitoring before, during and after infusion, and long-term monitoring of patients.
Prav tako bo zagotovilo, da bodo zdravniki, ki bodo predpisovali zdravilo, prejeli izobraževalno gradivo, ki bo vsebovalo pomembne informacije o varnosti zdravila, in kontrolni seznam o potrebnih pregledih, zdravilih za zmanjšanje neželenih učinkov, spremljanju pred infuzijo, med njo in po njej ter dolgoročnim spremljanjem bolnikov.
Side effects reported with Lemtrada are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Lemtrada, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Lemtrada is given as an infusion (drip) into a vein over about 4 hours.
Zdravilo Lemtrada se daje z infundiranjem (kapalno infuzijo) v veno, ki traja približno štiri ure.
The active substance in Lemtrada, alemtuzumab, is a type of protein called a monoclonal antibody that has been designed to attach to another protein called CD52.
Učinkovina v zdravilu Lemtrada, alemtuzumab, je vrsta beljakovine, imenovana monoklonsko protitelo, ki je zasnovana tako, da se veže na drugo beljakovino, imenovano CD52.
Lemtrada has been studied in two main studies involving 1,421 patients with relapsing-remitting multiple sclerosis.
Zdravilo Lemtrada so raziskali v dveh glavnih študijah, ki sta vključevali 1 421 bolnikov z recidivno-remitentno multiplo sklerozo.
For those patients who needed one or two additional infusions with Lemtrada, the number of relapses was lower, and disability progression was slower, compared with the previous year.
Pri bolnikih, ki so potrebovali eno ali dve dodatni infuziji zdravila Lemtrada, je bilo število recidivov nižje, bolezen pa je v primerjavi s prejšnjim letom napredovala počasneje.
In both studies, Lemtrada was compared with another medicine for multiple sclerosis, interferon beta-1a.
V obeh študijah so zdravilo Lemtrada primerjali z drugim zdravilom za zdravljenje multiple skleroze, interferonom beta-1a.
The first study involved previously untreated patients, while the second study involved patients whose disease had relapsed despite treatment.
Prva študija je vključevala bolnike, ki še niso bili zdravljeni, druga pa bolnike, pri katerih se je bolezen kljub zdravljenju ponovila.
It is initially given in two courses of treatment: a first course of 12 mg daily for 5 days, followed 12 months later by a second course of 12 mg daily for 3 days.
Na začetku se daje v dveh ciklih zdravljenja: prvemu petdnevnemu ciklu z odmerkom 12 mg dnevno, čemur 12 mesecev pozneje sledi drugi tridnevni cikel z odmerkom 12 mg dnevno.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lemtrada have also 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 Lemtrada upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What is Lemtrada and what is it used for?
Kaj je zdravilo Lemtrada in za kaj se uporablja?
Patients will receive a patient alert card and a guide explaining the risks with the medicine and symptoms of Lemtrada's serious side effects.
Bolniki bodo prejeli opozorilno kartico za bolnika in vodnik, v katerem bodo pojasnjena tveganja, povezana z zdravilom, in simptomi pri resnih neželenih učinkih zdravila Lemtrada.
With regards to safety, Lemtrada has rare but serious side effects, including disorders of the heart, blood vessels and immune system and measures have been put in place to minimise this risk.1
Kar zadeva varnost, ima zdravilo Lemtrada redke, a resne neželene učinke, vključno z boleznimi srca, ožilja in imunskega sistema, vendar so bili uvedeni ukrepi za zmanjšanje tega tveganja.1
Treatment should only be started and supervised by a neurologist experienced in treating MS.
Zdravljenje lahko uvede in nadzoruje le nevrolog, ki ima izkušnje z zdravljenjem multiple skleroze.
When alemtuzumab attaches to the lymphocytes, it causes them to die, and they are replaced by new lymphocytes.
Ko se alemtuzumab veže na limfocite, ti zato odmrejo in zamenjajo jih novi limfociti.
In the first study, the average number of relapses per year in patients given Lemtrada was less than half the number in patients given interferon beta-1a (0.18 versus 0.39), but there was no meaningful effect in terms of progression of disability.
V prvi študiji je bilo pri bolnikih, ki so prejemali zdravilo Lemtrada, v povprečju več kot polovico manj recidivov na leto kot pri bolnikih, ki so prejemali interferon beta-1a (0,18 v primerjavi z 0,39), v smislu napredovanja invalidnosti pa pomembnega učinka ni bilo.
Lemtrada must not be used in patients with HIV and in patients with severe infections.
Zdravilo Lemtrada se ne sme uporabljati pri bolnikih, okuženih z virusom HIV, in tistih s hudimi okužbami.
Lemtrada is a medicine that is used to treat adults with relapsing-remitting multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves as well as the nerves themselves.
Lemtrada je zdravilo, ki se uporablja za zdravljenje odraslih z „recidivno-remitentno“ multiplo sklerozo, tj. boleznijo, pri kateri vnetje poškoduje zaščitno ovojnico okoli živcev in živce same.
Lemtrada must not be used in patients with coagulopathy (problems with blood clotting) or in patients who are taking anti-platelet or anti coagulant therapy.
Zdravilo Lemtrada se ne sme uporabljati pri bolnikih s koagulopatijo (težavami s strjevanjem krvi) ali tistih, ki jemljejo antitrombotike ali antikoagulante.
In the second study, the average number of relapses per year in patients given Lemtrada was half the number in patients given interferon beta-1a (0.26 versus 0.52), and around 13% of patients given Lemtrada had a sustained progression of disability compared with around 21% of patients given interferon beta-1a.
V drugi študiji je bilo pri bolnikih, ki so prejemali zdravilo Lemtrada, v povprečju približno polovico manj recidivov na leto kot pri bolnikih, ki so prejemali interferon beta-1a (0,26 v primerjavi z 0,52), trajnejše napredovanje invalidnosti pa je prizadelo približno 13 % bolnikov, ki so prejemali zdravilo Lemtrada, v primerjavi z 21 % bolnikov, ki so prejemali interferon beta-1a.
It must not be used in patients with uncontrolled hypertension (high blood pressure), patients who have had arterial dissection (tears) of the cervicocephalic arteries (blood vessels in the head and neck), stroke, angina pectoris (pains to the chest, jaw and back, brought on by physical effort and due to problems with the blood flow to the heart) or myocardial infarction (heart attack).
Ne sme se uporabljati pri bolnikih z nenadzorovano hipertenzijo (visokim krvnim tlakom) ter tistih, ki so doživeli arterijsko disekcijo (raztrganje) cervikocefalnih arterij (krvnih žil v glavi in vratu), možgansko kap, angino pektoris (bolečine v prsih, čeljusti in hrbtu zaradi telesnega napora ter težav z dotokom krvi v srce) ali miokardni infarkt (srčni napad).
It should be given in a hospital with access to intensive care, as well as equipment and specialist staff for managing serious reactions and side effects that can occur with Lemtrada.
Zdravilo se lahko daje le v bolnišničnem okolju, kjer je neposreden dostop do intenzivne nege ter so na voljo oprema in specialisti za obvladovanje hudih reakcij ter neželenih učinkov, ki se lahko pojavijo pri prejemanju zdravila Lemtrada.
The most common side effects with Lemtrada (which may affect more than 1 in 5 people) are rash, headache, fever and respiratory tract infections (throat and chest infections).
Najpogostejši neželeni učinki zdravila Lemtrada (ki se lahko pojavijo pri več kot 1 bolniku od 5) so izpuščaj, glavobol, povišana telesna temperatura in okužbe dihal (okužbe žrela in prsnega koša).
The most important side effects with Lemtrada are autoimmune conditions (where the body's defence system attacks normal tissue), including thyroid gland disorders, immune thrombocytopenic purpura (a bleeding disorder caused by low blood platelet counts) and kidney damage, as well as low blood cell counts, reactions to the infusion and infections.
Najpomembnejši neželeni učinki zdravila Lemtrada so avtoimunska stanja (pri katerih obrambni mehanizem telesa napade normalno tkivo), vključno z boleznimi ščitnice, imunsko trombocitopenično purpuro (motnjo strjevanja krvi, ki jo povzroča nizko število rdečih krvnih celic), okvaro ledvic, nizkim številom krvnih celic, z infuzijo povezanimi reakcijami in okužbami.
Patients should receive certain medicines before or during treatment to reduce the side effects.
Za zmanjšanje neželenih učinkov morajo bolniki pred zdravljenjem ali med njim prejemati določena zdravila.
How is Lemtrada used?
Kako se zdravilo Lemtrada uporablja?
In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Pri multipli sklerozi se imunski sistem (naravni obrambni mehanizem telesa) ne odziva normalno in napada dele osrednjega živčevja (možgane, hrbtenjačo in optični živec [živec, ki pošilja signale iz očesa v možgane]) ter povzroča vnetje, ki poškoduje živce in zaščitno ovojnico okrog njih.
Lemtrada can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Lemtrada je le na recept.
Up to two additional courses, each of 12 mg daily for 3 days, can be given at 12-month intervals.
V 12-mesečnih razmikih je mogoče zdravilo dati v še največ dveh dodatnih tridnevnih ciklih z odmerkom 12 mg dnevno.
For the full list of side effects of Lemtrada, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lemtrada, glejte navodilo za uporabo.
The medicine must not be used in patients with autoimmune diseases besides MS. For the full list of restrictions, see the package leaflet.
Prav tako se ne sme uporabljati pri bolnikih z drugimi avtoimunskimi boleznimi poleg multiple skleroze.
How does Lemtrada work?
Kako zdravilo Lemtrada deluje?
Lemtrada contains the active substance alemtuzumab.
Zdravilo Lemtrada vsebuje učinkovino alemtuzumab.
It is available as tablets (100 mg).
Na voljo je v obliki tablet (100 mg).
The full EPAR for Lamivudine Teva 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 Lamivudine Teva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Lamivudine Teva on 23 October 2009.
Evropska komisija je dovoljenje za promet z zdravilom Lamivudine Teva, veljavno po vsej Evropski uniji, odobrila dne 23. oktobra 2009.
This means that Lamivudine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zeffix.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Zeffix.
EPAR summary for the public lamivudine
Povzetek EPAR za javnost lamivudin
What are the benefits and risks of Lamivudine Teva?
Kakšne so koristi in tveganja, povezani z zdravilom Lamivudine Teva?
It is used in patients with compensated liver disease (when the liver is damaged but functions normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised levels of the liver enzyme ‘alanine aminotransferase' [ALT] and signs of damage when liver tissue is examined under a microscope).
Uporablja se pri bolnikih s kompenzirano boleznijo jeter (jetra so poškodovana, a delujejo normalno), ki kažejo tudi znake še vedno potekajočega razmnoževanja virusa in znake okvare jeter (povišane ravni jetrnega encima „alanin-aminotransferaze“ [ALT] in znake poškodb, ki so vidni pod mikroskopom).
For more information about treatment with Lamivudine Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Lamivudine Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
If the hepatitis B virus can still be found in the blood after six months of treatment, the doctor should consider changing treatment to reduce the risk of resistance.
Če je po šestih mesecih zdravljenja virus hepatitisa B v krvi še vedno prisoten, mora zdravnik razmisliti o spremembi zdravljenja, da se zmanjša tveganje za razvoj odpornosti.
This is a summary of the European public assessment report (EPAR) for Lamivudine Teva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lamivudine Teva.
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 Lamivudine Teva.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Lamivudine Teva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Because Lamivudine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Ker je zdravilo Lamivudine Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
Lamivudine Teva is a ‘generic medicine'.
Lamivudine Teva je „generično zdravilo“.
Lamivudine Teva is used to treat adult patients who have chronic (long term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus).
Zdravilo Lamivudine Teva se uporablja za zdravljenje odraslih bolnikov s kroničnim (dolgotrajnim) hepatitisom B (okvaro jeter zaradi okužbe z virusom hepatitisa B).
Patients infected with a virus that has the ‘YMDD mutation' (a change in the virus's DNA that is often found after treatment with lamivudine) should take Lamivudine Teva in combination with another medicine against hepatitis B. For more information, please see the Summary of Product Characteristics (also part of the EPAR).
Bolniki, okuženi z YMDD mutacijo virusa (tj. spremembo v virusni DNK, ki je pogosta po zdravljenju z lamivudinom), morajo zdravilo Lamivudine Teva jemati v kombinaciji z drugim zdravilom proti hepatitisu B. Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Treatment with Lamivudine Teva should be initiated by a doctor who has experience in the management of chronic hepatitis B. The recommended dose of Lamivudine Teva is 100 mg once a day.
Zdravljenje z zdravilom Lamivudine Teva mora uvesti zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa B. Priporočeni odmerek zdravila Lamivudine Teva je 100 mg enkrat na dan.