natgillin/translations-raw huggingface dataset:
Metalyse should not be used in patients who have or have had recent bleeding problems or major surgery, or have a disease which may cause bleeding (such as a past stroke or severe high blood pressure).
Zdravila Metalyse prav tako ne smejo prejeti bolniki, ki imajo ali so pred nedavnim imeli težave s krvavitvijo ali večjo operacijo, ali imajo bolezenske težave, ki lahko povzročijo krvavitev (kot je nedavna kap ali močno povišan krvni tlak).
Metalyse is given once as a single injection into a vein over around 10 seconds.
Daje se z eno injekcijo v veno v trajanju približno 10 sekund.
Metalyse is used to treat adults suspected of having an acute myocardial infarction (heart attack) within six hours of the first symptoms appearing.
Zdravilo Metalyse se uporablja za zdravljenje odraslih, pri katerih obstaja sum za akutni miokardni infarkt (srčni napad) in se daje v 6 urah po pojavu prvih simptomov.
Metalyse should not be used in people who have had an anaphylactic reaction (a severe, lifethreatening allergic reaction) to tenecteplase, gentamicin (an ingredient found in the medicine) or any of the other ingredients.
Zdravilo Metalyse se ne sme uporabljati pri ljudeh, ki so imeli v preteklosti anafilaktično reakcijo (hudo, življenje ogrožajočo alergijsko reakcijo) na tenekteplazo, gentamicin (sestavino zdravila) ali katero koli drugo sestavino zdravila.
For the full list of all side effects reported with Metalyse, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Metalyse, glejte navodilo za uporabo.
The active substance in Metalyse, tenecteplase, is a modified copy of the human enzyme ‘tissue plasminogen activator', which the body uses to break down clots.
Zdravilna učinkovina v zdravilu Metalyse, tenekteplaza, je spremenjena kopija človeškega encima, in sicer tkivnega plazminogenskega aktivatorja, ki ga telo uporablja za razgradnjo krvnih strdkov.
Why has Metalyse been approved?
Zakaj je bilo zdravilo Metalyse odobreno?
It contains the active substance tenecteplase.
Vsebuje zdravilno učinkovino tenekteplazo.
The most common bleedings (seen in between 1 and 10 patients in 100) are epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), ecchymosis (bleeding beneath the skin), urogenital haemorrhage (bleeding from the structures that carry urine or from the genital area), bleeding at the injection site, and bleeding at puncture site.
Največkrat se je pojavila epistaksa (krvavitev iz nosu), gastrointestinalna hemoragija (krvavitev v želodcu ali črevesju), ekhimoza (podkožna krvavitev), urogenitalna hemoragija (krvavitev v sečilih ali genitalnem predelu) ter krvavitev na mestu injiciranja ali mestu punkcije.
The dose to be given is adjusted according to the patient's weight (see the package leaflet).
Odmerek je treba prilagoditi glede na bolnikovo telesno maso (glejte navodila za uporabo).
Metalyse was compared with alteplase (another medicine used to treat heart attacks) in one main study involving about 17,000 adults who were having a heart attack.
Zdravilo Metalyse so v eni glavni študiji, v katero je bilo vključenih 17 000 odraslih s srčnim napadom, primerjali z alteplazo (drugim zdravilom, ki se uporablja pri srčnem napadu).
The most common side effect with Metalyse was haemorrhage (bleeding).
Najpogostejši neželeni učinek zdravila Metalyse so bile krvavitve.
The patients were given either medicine within six hours of their symptoms appearing in addition to either aspirin or heparin.
Bolniki so poleg aspirina ali heparina prejeli eno ali drugo zdravilo v šestih urah po pojavu simptomov.
What is Metalyse used for?
Za kaj se zdravilo Metalyse uporablja?
How has Metalyse been studied?
Kako je bilo zdravilo Metalyse raziskano?
How does Metalyse work?
Kako zdravilo Metalyse deluje?
What is Metalyse?
Kaj je zdravilo Metalyse?
How is Metalyse used?
Kako se zdravilo Metalyse uporablja?
• The schedule of follow-up of patients
• urnik nadaljnjega spremljanja bolnikov
• The need for screening of donors using patient questionnaire and laboratory tests for hepatitis C,
• potrebo po testiranju darovalcev z uporabo vprašalnikov laboratorijskih preskusov za hepatitis C,
The Marketing Authorisation Holder (MAH) shall ensure that the medicinal product will be distributed only to Healthcare Establishments that meet criteria described in the Risk Management Plan.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da se zdravilo priskrbi le zdravstvenim ustanovam, ki izpolnjujejo merila, opisana v načrtu za obvladovanje tveganj.
• The handling of ChondroCelect and its preparation for the implantation
• ravnanje z zdravilom ChondroCelect in njegova priprava za implantacijo
The educational programme for healthcare professionals contains the following components:
Izobraževalni program za zdravstvene delavce vsebuje:
• The surgical checklist to be completed at the operating theatre immediately prior to the first incision confirming the right patient, the right product, the right side of the implantation, and the type of biological membrane and fibrin sealant to be used in the procedure.
• kirurški kontrolni seznam, ki se izpolni v operacijski dvorani tik pred prvim vrezom, s katerim se potrdi bolnikova identiteta, ustreznost zdravila, ustreznost predela implantacije in vrsta biološke membrane ter fibrinskega sredstva za zapiranje ran, ki se uporabi med posegom.
• Training material for other Healthcare Professionals • Informed consent for the patients to be signed prior to the treatment with ChondroCelect
• gradivo za usposabljanje drugih zdravstvenih delavcev • privolitev bolnikov, ki s podpisom zagotovijo, da se seznanjeni z zdravljenjem z zdravilom
The training material for other Healthcare Professionals shall include the following key messages and components:
Gradivo za usposabljanje drugih zdravstvenih delavcev mora vsebovati naslednje ključne podatke in elemente:
• The implantation procedure by knee-joint arthrotomy
• postopek implantacije z artrotomijo kolenskega sklepa
The Marketing Authorisation Holder (MAH) shall ensure, prior to the distribution of the product to a particular Healthcare Establishment, that all surgeons and other healthcare professionals involved in the handling and administration of ChondroCelect or its components, as well as those involved in follow-up of patients treated with ChondroCelect in the Healthcare Establishment, receive training as per the educational programme described in the Risk Management Plan.
Imetnik dovoljenja za promet z zdravilom mora določeni zdravstveni ustanovi pred dobavo zdravila po izobraževalnem programu, ki je opisan v načrtu za obvladovanje tveganj zagotoviti usposabljanje vseh kirurgov in drugih zdravstvenih delavcev, ki uporabljajo in dajejo zdravilo ChondroCelect ali njegove sestavine, ter vseh, ki sodelujejo pri nadaljnjem spremljanju bolnikov, zdravljenih z zdravilom ChondroCelect v zdravstveni ustanovi.
• The handling of the biopsy harvest
• ravnanje z odvzetim tkivom po biopsiji
The training materials for Surgeons shall include the following key messages and components:
Gradivo za usposabljanje kirurgov mora vsebovati naslednje ključne podatke in elemente: • povzetek glavnih značilnosti zdravila
This summary was last updated in 01-2011.
Povzetek je bil nazadnje posodobljen 01-2011.
The vaccination schedule to be used depends on the age of the child and should be based on official
Shema cepljenja, ki se bo uporabila, je odvisna od starosti otroka in mora temeljiti na uradnih
Prevenar is a vaccine.
Zdravilo Prevenar je cepivo.
The full EPAR for Prevenar 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 Prevenar je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The additional studies showed that Prevenar was safe and effective in children up to the age of five years.
Dodatne študije so pokazale, da je zdravilo Prevenar varno in učinkovito pri otrocih do petega leta starosti.
This is a summary of the European public assessment report (EPAR) for Prevenar.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Prevenar.
What benefit has Prevenar shown during the studies?
Kakšne koristi je zdravilo Prevenar izkazalo med študijami?
For more information about treatment with Prevenar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Prevenar preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
What is the risk associated with Prevenar?
Kakšna tveganja so povezana z zdravilom Prevenar?
The European Commission granted a marketing authorisation valid throughout the European Union for Prevenar to Wyeth Lederle Vaccines S.A. on 2 February 2001.
Evropska komisija je dovoljenje za promet z zdravilom Prevenar, veljavno po vsej Evropski uniji, odobrila družbi Wyeth Lederle Vaccines S.A. dne 2. februarja 2001.
In Europe, it is estimated that these are responsible for about 54% to 84% of invasive infections (infections that have spread into the body) in infants and children under the age of two years, and for about 62% to 83% of invasive infections in children aged between two and five
Po evropskih ocenah so ti serotipi odgovorni za približno 54 % do 84 % invazivnih okužb (okužb, ki so se razširile po telesu) dojenčkov in otrok, ki so mlajši od dveh let, in približno 62 % do 83 % invazivnih okužb otrok, ki so stari med dvema in pet let.
Pneumococcal saccharide conjugated vaccine, adsorbed
konjugirano pnevmokokno saharidno cepivo, adsorbirano
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
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Prevenar, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede
The CHMP decided that Prevenar's benefits are greater than its risks and recommended that Prevenar
CHMP je zaključil, da so koristi zdravila Prevenar večje od z njim povezanih tveganj, in priporočil, da se
The most common side effects with Prevenar (seen in more than 1 patient in 10) are vomiting, diarrhoea, loss of appetite, reactions at the site of the injection (redness, hardening, swelling or pain), fever, irritability, drowsiness and restless sleep.
Najpogostejši neželeni učinki zdravila Prevenar (opaženi pri več kot 1 bolniku od 10) so bruhanje, driska, izguba teka, reakcije na mestu injiciranja (rdečina, zatrdlina, otekanje ali bolečina), povišana telesna temperatura, razdražljivost, zaspanost in nemiren spanec.
Prevenar was given at two, four, six and 12 to 15 months of age.
Cepljenje je bilo izvedeno v 2., 4., 6. in 12.-15. mesecu starosti.
However, the CHMP concluded that this is unlikely to lead to a difference in the rate of protection against infection with S. pneumoniae following a booster injection, when Prevenar is used as part of a routine immunisation programme in which most infants are vaccinated.
Vendar pa je CHMP odločil, da verjetno ne bo povzročilo razlike v stopnji zaščite proti okužbi z bakterijo S. pneumoniae po poživitveni injekciji, kadar se zdravilo Prevenar uporablja kot del rednega imunizacijskega programa, v katerem se je cepljenih večina otrok.
Alternatively, when Prevenar is given as part of a ‘universal infant immunisation programme' (when all infants in an area are vaccinated at around the same time), two doses can be given with an interval of at least two months, followed by a booster at 11 to 15 months of age.
Kadar se zdravilo Prevenar daje kot del „splošnega imunizacijskega programa dojenčkov“ (kadar se vsi dojenčki na določenem območju cepijo ob približno istem času), se lahko izjemoma dasta dva odmerka, med katerima mora biti vsaj dvomesečni presledek, sledi pa jima poživitveni odmerek v 11. do 15. mesecu starosti.
The vaccine is also ‘adsorbed' (fixed) onto an aluminium compound to stimulate a better response.
Cepivo je tudi „adsorbirano“ (vezano) na površino aluminijeve spojine, kar spodbudi boljši odziv.
Prevenar contains the polysaccharides from different types of S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F).
Zdravilo Prevenar vsebuje polisaharide iz različnih tipov bakterije S. pneumoniae (serotipi 4, 6B, 9V, 14, 18C, 19F in 23F).
Additional studies looked at the effectiveness and safety of Prevenar in older infants and children, and at the development of antibodies in infants after the two-dose immunisation schedule followed by a
V dodatnih študijah so raziskovali učinkovitost in varnost zdravila Prevenar pri starejših dojenčkih in otrocih ter razvoj protiteles pri dojenčkih po imunizacijski shemi dveh odmerkov, ki jima je sledila
When a person is given the vaccine, the immune system recognises the bacterium contained in the vaccine as ‘foreign' and makes antibodies against it.
Ko oseba prejme cepivo, imunski sistem prepozna bakterijo v cepivu kot „tujek“ in proti njej razvije protitelesa.
These include sepsis (blood infection), meningitis (infection of the membranes that surround the brain and spine), pneumonia (infection of the lungs), otitis media (infection of the middle ear) and bacteraemia (bacteria detected in the blood).
Med njimi so sepsa (okužba krvi), meningitis (okužba membran, ki obdajajo možgane in hrbtenjačo), pljučnica (okužba pljuč), otitis media (vnetje srednjega ušesa) in bakteriemija (prisotnost bakterij v krvi).
A fourth dose (booster) is recommended in the second year of life.
Četrti (poživitveni) odmerek je priporočljivo dati v drugem letu življenja.
The effectiveness of Prevenar in the prevention of S. pneumoniae invasive disease has been studied in almost 38,000 infants.
Učinkovitost zdravila Prevenar pri preprečevanju invazivne bolezni, ki jih povzroča bakterija S. pneumoniae, so raziskali pri skoraj 38 000 dojenčkih.
Half of the infants received Prevenar, and the remainder received another vaccine that is not active against S. pneumoniae.
Polovica dojenčkov je prejela zdravilo Prevenar, preostali pa so prejeli cepivo, ki ni učinkovito proti bakteriji S. pneumoniae.
During the main study, 49 cases of infection due to the serotypes 4, 6B, 9V, 14, 18C, 19F and 23F of S. pneumoniae were seen among the infants who received the control vaccine, compared with three cases among the infants vaccinated with Prevenar.
Med glavno študijo so pri dojenčkih, ki so prejeli kontrolno cepivo, odkrili 49 primerov okužbe zaradi serotipov S. pneumoniae 4, 6B, 9V, 14, 18C, 19F in 23F, medtem ko so pri dojenčkih, ki so jih cepili z zdravilom Prevenar, odkrili tri primere okužb.
Prevenar contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule' that surrounds the S. pneumoniae bacterium.
Zdravilo Prevenar vsebuje majhne količine polisaharidov (vrste sladkorja), pridobljenih iz „ovojnice“, ki obdaja bakterijo S. pneumoniae.
The vaccine is given by injection into the thigh muscle in infants, or into the upper arm muscle in
Cepivo se daje z injekcijo v stegensko mišico pri dojenčkih ali mišico nadlakti pri majhnih otrocih.
Prevenar should not be used in children who may be hypersensitive (allergic) to the Streptococcus vaccine, to any of the other ingredients or to the diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria).
Zdravila Prevenar ne smejo uporabljati otroci, ki utegnejo biti preobčutljivi za (alergični na) cepivo proti bakteriji Streptococcus, katero od drugih pomožnih sestavin zdravila ali davični toksoid (oslabljeni toksin iz bakterije, ki povzroča davico).
These polysaccharides have been purified, then ‘conjugated' (attached) to a carrier to help them be better recognised by the immune system.
Te polisaharide se prečisti, nato „konjugira“ (veže) na nosilec, zaradi česar jih imunski sistem lahko bolje prepozna.
The first dose is usually given at two months of age with an interval of at least one month between doses.
Prvi odmerek običajno prejmejo v drugem mesecu starosti, pri čemer mora biti med odmerki vsaj enomesečni presledek.
The immune system will then be able to produce antibodies more quickly when it is exposed to the bacterium again.
Ko bo imunski sistem naslednjič izpostavljen bakteriji, bo lahko hitreje izdelal protitelesa.
Prevenar is used to vaccinate infants and children aged between two months and five years against diseases caused by S. pneumoniae.
Zdravilo Prevenar se uporablja za cepljenje otrok od 2. meseca do 5. leta starosti proti boleznim, ki jih povzroča bakterija Streptococcus pneumoniae.
Vaccination should be postponed in children with a severe infection
Cepljenje je treba pri otrocih s hudim vnetjem in zelo povišano
The marketing authorisation is valid for
Dovoljenje za promet z zdravilom
The study measured the number of children who developed an S. pneumoniae invasive disease during the 3.5 years of the study.
V študiji so preverjali število otrok, pri katerih se je v 3,5letnem obdobju te študije pojavila invazivna bolezen zaradi bakterije S. pneumoniae.
Prevenar was effective in preventing S. pneumoniae invasive disease.
Zdravilo Prevenar je bilo učinkovito proti invazivni bolezni, ki jo povzroča bakterija S. pneumoniae.
It is a suspension for injection that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae).
Je suspenzija za injiciranje, ki vsebuje dele bakterije Streptococcus
• Children aged between 24 months and five years need one single dose.
• Otroci, ki so stari od 24 mesecev do pet let, potrebujejo en sam odmerek.
• Infants aged between two and six months need three doses.
• Dojenčki, stari od dva do šest mesecev, potrebujejo tri odmerke.
This helps to
To pomaga pri obrambi pred boleznijo.
• Children aged between 12 and 23 months need two doses, with an interval of at least two months between doses.
• Otroci, ki so stari od 12 do 23 mesecev, potrebujejo dva odmerka, med katerima mora biti vsaj dvomesečni presledek.
• Infants aged between seven and 11 months need two doses, with an interval of at least one month between doses.
• Dojenčki, ki so stari od sedem do 11 mesecev, potrebujejo dva odmerka, med katerima mora biti vsaj enomesečni presledek.
S. pneumoniae, but to a lower level than the three-dose schedule.
Pri dojenčkih je imunizacijska shema dveh odmerkov sicer povzročila razvoj protiteles proti bakteriji S. pneumoniae, a v manjšem obsegu kot shema treh odmerkov.
For the full list of all side effects reported with
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Prevenar, glejte navodilo za uporabo.
This summary was last updated in November 2017.
Povzetek je bil nazadnje posodobljen novembra 2017.
It is given to dogs once daily on an empty stomach at least one hour before the next meal.
Daje se psom enkrat na dan na prazen želodec, vsaj eno uro pred naslednjim obrokom.
The full EPAR for Galliprant can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Galliprant je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Hands should be washed after handling the medicine.
Po ravnanju z zdravilom si je treba umiti roke.
The European Commission granted a marketing authorisation valid throughout the EU for Galliprant on 9 January 2018.
Evropska komisija je dovoljenje za promet z zdravilom Galliprant, veljavno po vsej Evropski uniji, izdala 09/01/2018.
The most common side effect with Galliprant (which may affect more than 1 in 10 animals) is mild and generally short-lived vomiting.
Najpogostejši neželeni učinek zdravila Galliprant (ki lahko prizadene več kot 1 žival od 10) je blago in na splošno kratkotrajno bruhanje.
This is a summary of the European public assessment report (EPAR) for Galliprant.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Galliprant.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Galliprant's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Galliprant večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It is not intended to provide practical advice on how to use Galliprant.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
If the medicine is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
Če človek zdravilo nenamerno zaužije, se mora nemudoma posvetovati z zdravnikom.
The dose is based on the bodyweight of the dog and the length of treatment depends on the response.
Odmerek je odvisen od telesne mase psa, dolžina zdravljenja pa je odvisna od odziva nanj.
By blocking EP4, grapiprant helps relieve the signs of the condition.
zaviranjem EP4 tako pomaga ublažiti znake te bolezni.
Grapiprant works by blocking a specific target receptor called EP4, through which natural substances called prostaglandins act to produce pain in osteoarthritis.
Grapiprant deluje tako, da zavira poseben tarčni receptor EP4, prek katerega naravne snovi, imenovane prostaglandini, pri osteoartritisu povzročajo bolečino.
Galliprant is a veterinary medicine.
Galliprant je zdravilo za uporabo v veterinarski medicini.
What is Galliprant and what is it used for?
Kaj je zdravilo Galliprant in za kaj se uporablja?
What benefits of Galliprant have been shown in studies?
Kakšne koristi je zdravilo Galliprant izkazalo v študijah?
In total, 51% of dogs (120 of 235) were treated successfully with Galliprant at 28 days after the start of the treatment.
Skupno je bilo zdravljenje z zdravilom Galliprant 28 dni po začetku zdravljenja uspešno pri 51 % (120 od 235) psov.
Two field studies were conducted involving dogs mostly with mild to moderate osteoarthritis confirmed by radiography in at least one limb joint.
Izvedeni sta bili dve terenski študiji, v kateri so bili večinoma vključeni psi z blagim do zmernim osteoartritisom, potrjenim z rentgenskim slikanjem vsaj enega sklepa okončine.
If swallowed by a child, mild and reversible gastrointestinal signs and nausea may be seen.
Če ga zaužije otrok, se lahko pojavijo blage in reverzibilne prebavne motnje ter navzeja.
What are the risks associated with Galliprant?
Kakšna tveganja so povezana z zdravilom Galliprant?
For the full list of side effects and restrictions with Galliprant, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Galliprant glejte navodilo za uporabo.
Intermittent treatment may be beneficial in some dogs as signs of osteoarthritis come and go.
Pri nekaterih psih je lahko koristno občasno zdravljenje, saj se znaki osteoartritisa lahko pojavljajo in izginjajo.
Success was assessed by the dog owners and by veterinarians, using scoring systems for pain severity, pain interference and overall life quality.
Uspešnost zdravljenja so ocenjevali lastniki psov in veterinarji, ki so v ta namen uporabljali sisteme točkovanja za jakost bolečine, motnje zaradi bolečine in splošno kakovost življenja.
Why is Galliprant approved?
Zakaj je bilo zdravilo Galliprant odobreno?
Galliprant contains grapiprant, a non-steroidal, non-cyclooxygenase inhibiting anti-inflammatory drug (NSAID), of the piprant class, that works in a different way from other NSAIDs, which block a range of cyclo-oxygenase enzymes.
nesteroidno, neciklooksigenazno zavirajoče protivnetno zdravilo (NSAID) iz skupine piprantov, ki delujejo drugače kot drugi NSAID, ki zavirajo vrsto ciklooksigenaznih encimov.
It contains the active substance grapiprant.
Vsebuje zdravilno učinkovino grapiprant.
Galliprant is available as tablets and can only be obtained with a prescription.
Zdravilo Galliprant je na voljo v obliki tablet, njegovo predpisovanje in izdaja zdravila pa je le na recept.