FrancophonIA/ELRC3.0 huggingface dataset:
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Slovenian: Njegov namen je pojasniti, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) ocenil predloženo dokumentacijo, na podlagi česar je oblikoval priporočila glede uporabe zdravila.
English: Information on the prescription status of this product may be found on the label/outer package.
Slovenian: Informacije o predpisovanju tega zdravila lahko najdete na notranji/zunanji ovojnini.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Slovenian: Razmerje med koristmi in tveganji je na voljo v modulu 6 tega Evropskega javnega poročila o oceni zdravila (EPAR).
English: Since milk is routinely checked for bacteria and other signs of infection, early stages of an udder infection in a dairy cow can easily be diagnosed.
Slovenian: Ker se mleko redno preverja za vsebnost bakterij in druge znake okužbe, lahko pri molznih kravah z lahkoto odkrijemo zgodnje stopnje okužbe vimena.
English: What benefit has Pirsue shown during the studies?
Slovenian: Kakšne koristi je zdravilo Pirsue izkazalo med raziskavami?
English: These infections were caused by incorrect administration of the product by the operator who, by inserting the syringe without adequate cleansing procedures, also inserted pathogenic (disease causing) bacteria from the environment into the udder.
Slovenian: Te okužbe so bile posledice nepravilnega dajanja zdravila, pri čemer je oseba, ki je dajala zdravilo, vstavila brizgo brez primernega postopka čiščenja, zato je iz okolja v vime prenesla patogene bakterije (povzročitelje bolezni).
English: Milk samples were checked daily up to 30 days after treatment for bacteria and for other signs of infection.
Slovenian: Vzorce mleka so vsak dan do 30. dne po končanem zdravljenju preverjali za vsebnost bakterij in druge znake okužbe.
English: Pirsue is generally well tolerated in cows.
Slovenian: Krave na splošno dobro prenašajo zdravilo Pirsue.
English: Pirsue is given into each infected teat of the udder for 8 consecutive days.
Slovenian: Zdravilo Pirsue dajemo v vsak okužen sesek 8 dni zapored.
English: What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Slovenian: Koliko časa mora preteči, preden se žival lahko zakolje in meso porabi za prehrano ljudi (obdobje karence)?
English: However, in rare cases, serious bacterial udder infections have occurred after treatment.
Slovenian: Vendar so se v nekaterih redkih primerih po zdravljenju pojavile hude bakterijske okužbe vimena.
English: What is the time to allow before milk can be taken from the animal for human consumption?
Slovenian: Koliko časa mora preteči, preden se lahko mleko uporabi za prehrano ljudi?
English: Why has Pirsue been approved?
Slovenian: Zakaj je bilo zdravilo Pirsue odobreno?
English: In these studies, the effective concentration of pirlimycin required to stop bacterial growth was established.
Slovenian: V teh raziskavah so določili učinkovito koncentracijo pirlimicina, ki je potrebna za zaustavitev rasti bakterij.
English: Pirsue is used in dairy cows to treat subclinical mastitis caused by specific groups of bacteria.
Slovenian: Zdravilo Pirsue se uporablja za zdravljenje subkliničnega mastitisa pri molznih kravah, ki ga povzročajo posebne skupine bakterij.
English: It works by blocking the bacteria's ribosomes; this is the part of the cell where proteins are produced.
Slovenian: Deluje tako, da blokira delovanje bakterijskih ribosomov, ki v celicah tvorijo beljakovine.
English: The field trial showed that treatment with Pirsue at the recommended dose was effective in the treatment of subclinical udder infections.
Slovenian: Preskušanje na terenu je pokazalo, da je zdravljenje s priporočenim odmerkom zdravila Pirsue učinkovito pri zdravljenju subkliničnih okužb vimena.
English: Pirlimycin hydrochloride can cause severe eye and skin irritation.
Slovenian: Pirlimicin hidroklorid močno draži oči in kožo.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Pirsue exceed the risks for the treatment of subclinical mastitis in lactating cows and recommended that Pirsue be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristni učinki zdravila Pirsue za zdravljenje subkliničnega mastitisa pri kravah v obdobju laktacije večji od z njim povezanih tveganj, zato priporoča odobritev dovoljenja za promet z zdravilom Pirsue.
English: Special care must, therefore, be taken by the operator not to introduce pathogens into the teat.
Slovenian: To pomeni, da mora oseba, ki je daje zdravilo, biti posebno pozorna, da v sesek ne vnese patogenih organizmov.
English: The active substance in Pirsue is pirlimycin hydrochloride, an antibiotic of the lincosamide group.
Slovenian: Zdravilna učinkovina zdravila Pirsue je pirlimicin hidroklorid, ki je antibiotik iz skupine linkozamidov.
English: What is Pirsue used for?
Slovenian: Za kaj se zdravilo Pirsue uporablja?
English: It is given to dairy cows by infusion into the udder via the teat canal using a pre-filled syringe.
Slovenian: Daje se molznim kravam v vime preko seskovega kanala z infuzijo s pomočjo napolnjene brizge.
English: How has Pirsue been studied?
Slovenian: Kako je bilo zdravilo Pirsue raziskano?
English: The antimicrobial effectiveness of pirlimycin against different groups of bacteria causing disease in dairy cows was investigated in microbiological laboratories.
Slovenian: V mikrobioloških laboratorijih so raziskali učinkovitost protimikrobnega delovanja pirlimicina proti različnim skupinam bakterij, ki povzročajo bolezen pri molznih kravah.
English: The results of these studies showed that Pirsue is effective at inhibiting the bacterial growth of a range of bacteria.
Slovenian: Rezultati teh raziskav so pokazali, da zdravilo Pirsue učinkovito zavira rast določenih bakterij.
English: Pirsue is an antibiotic that contains pirlimycin hydrochloride as the active substance.
Slovenian: Zdravilo Pirsue je antibiotik, ki vsebuje zdravilno učinkovino pirlimicin hidroklorid.
English: How does Pirsue work?
Slovenian: Kako zdravilo Pirsue deluje?
English: Both, the teat and the udder should be adequately cleansed and the teat end disinfected before using Pirsue.
Slovenian: Pred uporabo zdravila Pirsue je treba sesek in vime primerno očistiti, konec seska pa razkužiti.
English: Skin that has been in contact with Pirsue should be washed and eyes should be flushed with water for 15 minutes immediately after exposure.
Slovenian: Oči je treba takoj po stiku z raztopino začeti spirati z vodo in nadaljevati s tem 15 minut.
English: What is Pirsue?
Slovenian: Kaj je zdravilo Pirsue?
English: After the last day of treatment with Pirsue, treated cows should not be slaughtered for 23 days.
Slovenian: Zdravljena krava se ne sme zaklati 23 dni po zadnjem dnevu zdravljenja z zdravilom Pirsue.
English: After the last day of treatment with Pirsue, milk from treated cows should not be used for 5 days.
Slovenian: Mleko zdravljenih krav se lahko začne uporabljati po 5 dnevih od zadnjega dneva zdravljenja z zdravilom Pirsue.
English: Care should, therefore, be taken by the user of the product to avoid contact with the solution.
Slovenian: Z zdravilom Pirsue je zato treba ravnati previdno, da preprečimo stik z raztopino.
English: Although the two effects actually have the same results, the first is the most important.
Slovenian: Čeprav imata ta dva učinka enake rezultate, je prvi najpomembnejši.
English: Most of its effects are probably due to this structural similarity.
Slovenian: Večina učinkov je verjetno posledica strukturne podobnosti.
English: Undesirable effects a.
Slovenian: Neželeni učinki a.
English: Children (0-17 years):
Slovenian: Otroci (0-17 let):
English: * frequency not known (cannot be estimated from the available data).
Slovenian: * neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: The symptoms of a severe allergic reaction may include:
Slovenian: Simptomi hude alergijske reakcije lahko vključujejo:
English: - Coagulation factors (Factor IX)
Slovenian: - koagulacijski faktorji (faktor IX)
English: • If you need long-term treatment, since muscle alterations may appear.
Slovenian: • če potrebujete dolgoročno zdravljenje, saj lahko pride do sprememb mišic.
English: Please note that these instructions may also apply to medication that you have used before or you can use later.
Slovenian: To navodilo morda velja tudi za zdravila, ki ste jih uporabljali pred tem, ali jih boste uporabljali kasneje.
English: This test is negative in primary fibrinolysis.
Slovenian: Ta test je pri primarni fibrinolizi negativen.
English: All these events have also been described as part of the natural evolution of SAH, as a result of diagnostic procedures such as angiography.
Slovenian: Vsi ti dogodki so bili opisani tudi kot del naravnega razvoja SAH kot rezultat diagnostičnih postopkov, kot je angiografija.
English: If any of these occur while you are taking [Invented name] by mouth, then stop taking [Invented name] and seek immediate medical advice.
Slovenian: • če imate hematurijo (kri v seču) iz zgornjih sečil,
English: - Hormonal medication such as oestrogens
Slovenian: - hormonska zdravila, kot so estrogeni
English: Not known*
Slovenian: Neznana*
English: Do not use a double dose to make up for a forgotten dose but continue to use the vials as usual.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, temveč z uporabo vial nadaljujte, kot običajno.
English: Unknown frequency:
Slovenian: Neznana pogostnost:
English: Elderly patients and patients with renal failure:
Slovenian: Starejši bolniki in bolniki z odpovedjo ledvic:
English: The safety and efficacy of EACA in children aged 0 to 17 years have not been established.
Slovenian: Varnost in učinkovitost aminokaprojske kisline pri otrocih, starih med 0 in 17 let, nista bili dokazani.
English: Fertility There are no clinical data on the effects of [invented name] on fertility.
Slovenian: Plodnost Ni podatkov o vplivu [izmišljeno ime] na plodnost.
English: Take this leaflet with you.
Slovenian: S seboj vzemite to navodilo za uporabo.
English: Therapeutic subgroup: Antihemorrhagics Pharmacotherapeutic group: Antifibrinolytics ATC code: B02AA01.
Slovenian: Terapevtska podskupina: antihemoragiki Farmakoterapevtska skupina: antifibrinolitiki Oznaka ATC: B02AA01.
English: Very rare
Slovenian: Redki zelo redki
English: When skeletal myopathy occurs, the possibility of damage to the cardiac muscle must also be considered.
Slovenian: Pri pojavu skeletne miopatije je treba pomisliti tudi na možnost poškodovane srčne mišice.
English: Plasmin can act on other clotting system components such as factors V and VIII and, in particular, fibrinogen.
Slovenian: Plazmin lahko deluje na druge sestavine strjevalnega sistema, kot sta faktorja V in VIII, in zlasti na fibrinogen.
English: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicine, even those obtained without a prescription, homeopathic, herbal and other healthrelated products, as it may be necessary to stop the treatment or adjust the dose of one of them.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta, homeopatske, zeliščne ali druge zdravilne pripravke, saj bo morda treba zdravljenje prekiniti ali prilagoditi odmerek.
English: • If you are allergic to aminocaproic acid or to any of the other ingredients of this medicine.
Slovenian: • če ste alergični na aminokaprojsko kislino ali katero koli sestavino tega zdravila,
English: The following adverse reactions have been reported from clinical trials, post-authorisation safety studies and from spontaneously-reported cases with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Slovenian: Med kliničnimi preskušanji, študijami varnosti po odobritvi dovoljenja za promet z zdravilom in spontanimi poročili poročajo o naslednjih neželenih učinkih z naslednjimi pogostnostmi: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do < 1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
English: Allergic reactions may occur uncommonly in patients receiving [Invented name] (in fewer than 1 in 100 patients but more than 1 in 1000 patients).
Slovenian: Alergijske reakcije se lahko pri bolnikih, ki uporabljajo zdravilo [Izmišljeno ime] pojavijo občasno (pri manj kot 1 od 100 bolnikov, a več kot 1 od 1.000 bolnikov).
English: This drug must not be administered without a definitive diagnosis and/or laboratory findings indicating hyperfibrinolysis (hyperplasminaemia).
Slovenian: Zdravila se ne sme uporabiti brez jasne diagnoze in/ali laboratorijskih izvidov, ki kažejo na hiperfibrinolizo (hiperplazminemijo).
English: Tell your doctor and stop using [invented name] if you experience:
Slovenian: Obvestite svojega zdravnika in prenehajte uporabljati zdravilo [Izmišljeno ime], če se pojavi kateri koli od naslednjih učinkov:
English: Carcinogenesis, mutagenesis and fertility disorders: No long-term studies have been conducted in animals to evaluate the carcinogenic or mutagenic potential of aminocaproic acid.
Slovenian: Karcinogeneza, mutageneza in motnje plodnosti: Pri živalih niso izvedli dolgoročnih študij, da bi ocenili karcinogeni ali mutageni potencial aminokaprojske kisline.
English: • dizziness, ringing or buzzing in ears,
Slovenian: • omotica, zvonjenje ali brenčanje v ušesih
English: • reduction in blood platelets which increases risk of bleeding or bruising
Slovenian: • zmanjšanje števila krvnih ploščic, kar poveča tveganje za krvavitve ali modrice
English: • increased pressure in the brain that can result in severe headache, visual disturbance,
Slovenian: • povečan tlak v možganih, ki lahko povzroči močne glavobole, motnje vida, bruhanje, omotico,
English: Total dosage should not exceed 18 g/m2 (600 mg/kg) in 24 hours.
Slovenian: Skupni odmerek ne sme preseči 18 g/m2 (600 mg/kg) v 24 urah.
English: • difficult or laboured breathing,
Slovenian: • težko ali oteženo dihanje
English: In case of overdose with <Aminocaproic acid-containing medicinal products>, tell your doctor or pharmacist immediately, go to the nearest hospital.
Slovenian: V primeru prevelikega odmerka zdravila <zdravila, ki vsebujejo aminokaprojsko kislino>, o tem takoj obvestite zdravnika ali farmacevta ali pojdite v najbližjo bolnišnico.
English: The consequences ranged from absence of effects and transient hypotension to acute renal failure resulting in death.
Slovenian: Posledice segajo od odsotnosti učinkov in prehodne hipotenzije do akutne ledvične odpovedi s posledično smrtjo.
English: It has been shown that there are evident relationships between the proteolytic activity of plasmin and the system that forms quinines, polypeptides with different biological effects basically related to inflammation and allergy.
Slovenian: Pokazalo se je, da obstajajo jasna razmerja med proteolitično aktivnostjo plazmina in sistemom, ki tvori kinine, polipeptide z različnimi biološkimi učinki, ki so v osnovi povezani z vnetjem in alergijo.
English: The clinical relevance of these findings is unknown (see section 5.3).
Slovenian: Klinični pomen teh ugotovitev ni znan (glejte poglavje
English: Aminocaproic acid has an inhibitor effect on this system, which takes place on two levels: on the one hand, at relatively low concentrations, it inhibits the action of plasminogen activators by a competitive mechanism; on the other, at higher concentrations it inhibits plasmin activity.
Slovenian: Aminokaprojska kislina ima zaviralni učinek na ta sistem, ki se odvija na dveh ravneh: po eni strani pri relativno nizkih koncentracijah zavira delovanje aktivatorjev plazminogena s kompetitivnim mehanizmom; po drugi strani pa pri višjih koncentracijah zavira aktivnost plazmina.
English: Rapid intravenous administration should be avoided, as it can cause hypotension, bradychardia and/or arrhythmias.
Slovenian: Hitro intravensko infundiranje je treba preprečiti, saj lahko povzroči hipotenzijo, bradikardijo in/ali aritmije.
English: If any of these occur during administration of [Invented name] your doctor/surgeon will stop treatment with the drug.
Slovenian: Če se med uporabo zdravila [Izmišljeno ime] pojavi kar koli od naštetega, bo vaš zdravnik/kirurg prenehal zdravljenje s tem zdravilom.
English: • skin rash with small, flat, red spots;
Slovenian: • kožni izpuščaj z majhnimi, ploskimi, rdečimi pikami
English: Some patients have tolerated doses of up to 100 g, while cases of acute kidney failure have been described after a dose of 12 g.
Slovenian: Nekateri bolniki so prenašali odmerke do 100 g, vendar so primere akutne odpovedi ledvic opisali že po odmerku 12 g.
English: • If bleeding is due to a condition called disseminated intravascular coagulation.
Slovenian: • če je krvavitev posledica bolezni, imenovane diseminirana intravaskularna koagulacija.
English: It is widely distributed (it easily spreads to the tissues, appearing in semen, synovial fluid and foetal tissue) and it is excreted in urine, largely unaltered, with a terminal elimination half life of approximately 2 hours.
Slovenian: Dobro se porazdeli (v tkivu se preprosto širi, pojavi se v spermi, sinovijski tekočini in tkivu zarodka) in se izloči s sečem, v veliki meri nespremenjena, s končnim razpolovnim časom približno 2 uri.
English: The most important affect the fibrinolytic enzyme system, the mechanism responsible for dissolving fibrin meshes and, therefore, clots.
Slovenian: Najpomembnejši vplivajo na fibrinolitični encimski sistem, mehanizem, ki je odgovoren za raztapljanje fibrinskih mrežic in s tem strdkov.
English: Neurological effects
Slovenian: Nevrološki učinki
English: Ask your doctor or pharmacist for advice before taking any medicine.
Slovenian: Posvetujte se s svojim zdravnikom ali s farmacevtom, preden vzamete katero koli zdravilo.
English: • swelling of your eyelids, face, lips and tongue
Slovenian: • otekanje vek, obraza, ustnic in jezika
English: If any of the side effects is serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: In case of dizziness or drowsiness, driving vehicles and using machines is not recommended.
Slovenian: V primeru omotice ali dremavosti ni priporočljivo voziti avtomobila ali upravljati s stroji.
English: Thrombophlebitis, a possibility with all intravenous treatments, should be avoided, paying special attention to appropriate needle insertion and fixation.
Slovenian: Tromboflebitis, do katerega lahko pride pri vseh intravenskih zdravljenjih, je treba preprečiti, ob čemer je treba posebno pozornost nameniti ustrezni vstavitvi in pritrditvi igle.
English: If you are pregnant, thinking about becoming pregnant or are breastfeeding, ask your doctor or pharmacist before starting this treatment.
Slovenian: Če ste noseči, načrtujete zanositev ali dojite, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: • decrease in blood pressure;
Slovenian: • zmanjšanje krvnega tlaka
English: Aminocaproic acid should therefore not be administered in case of haematuria originating in the upper urinary tract unless the expected benefits more than exceed the risks.
Slovenian: Aminokaprojske kisline se zato ne sme uporabiti v primeru hematurije, ki izvira v zgornjih sečilih, razen če so pričakovane koristi večje od tveganj.
English: Effects on ability to drive and use machines No studies have been conducted on the effects on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost vožnje in upravljanja s stroji Študij o vplivu na sposobnost vožnje in upravljanje s stroji niso izvedli.
English: Aminocaproic acid is not very toxic, so intoxication can only occur in very exceptional cases, such as in cases of relative overdose with kidney failure.
Slovenian: Aminokaprojska kislina ni zelo toksična, zato se zastrupitev pojavi le v izjemno redkih primerih, kot na primer v primerih relativnega prevelikega odmerjanja z odpovedjo ledvic.
English: The most commonly reported adverse reactions during treatment are dizziness, hypotension and headache; hypotension is more likely to occur with rapid infusion.
Slovenian: Neželeni učinki, o katerih so med zdravljenjem najpogosteje poročali, so omotica, hipotenzija in glavobol; bolj verjetno je, da se bo hipotenzija pojavila pri hitrem infundiranju zdravila.
English: Rapid infusion
Slovenian: Hitro infundiranje
English: Warnings and precautions .
Slovenian: Opozorila in previdnostni ukrepi
English: The administration of the equivalent to the maximum therapeutic dose in humans in the diet of rats caused fertility disorders in both sexes.
Slovenian: Dajanje odmerka, ki pri ljudeh ustreza največjemu terapevtskemu odmerku, v prehrano podgan, je povzročilo motnje plodnosti pri obeh spolih.
English: Aminocaproic acid should not be used when there is evidence of an active intravascular clotting process (see section 4.4).
Slovenian: Aminokaprojske kisline se ne sme uporabiti ob znakih aktivnega intravaskularnega strjevanja krvi (glejte poglavje 4.4).
English: • sudden shortness of breath or difficulty in breathing, sudden coughing for no apparent reason, chest pain and pain on breathing (as these may suggest a blood clot in the lungs),
Slovenian: • nenadna kratka sapa ali težave z dihanjem, nenaden kašelj brez očitnega vzroka, bolečine v prsih in bolečine pri dihanju (to lahko nakazuje na krvni strdek v pljučih),
English: - Euglobulin clot test: abnormal in primary fibrinolysis and normal in DIC.
Slovenian: - Evglobulinski test strjevanja: nenormalen pri primarni fibrinolizi in normalen pri DIK.
English: The following tests can be performed to distinguish between the two disorders: - Platelet count: it is usually reduced in DIC but not in primary fibrinolysis.
Slovenian: Za razlikovanje med tema dvema motnjama so na voljo naslednji testi: - Število trombocitov: običajno je pri DIK zmanjšano, ne pa tudi pri primarni fibrinolizi.
English: The maximum daily dose should not exceed 24 g.
Slovenian: Največji dnevni odmerek ne sme preseči 24 g.
English: Aminocaproic acid inhibits the effect of plasminogen activators and, to a lesser extent, plasmin activity.
Slovenian: Aminokaprojska kislina zavira učinek aktivatorjev plazminogena in v manjšem obsegu tudi aktivnost plazmina.
English: • problems with bleeding or clotting,
Slovenian: • težave s krvavitvijo ali strjevanjem
English: Serious cases of myopathy and rhabdomyolysis have been reported; these are generally reversible of discontinuation of treatment but CPK must be monitored in patients undergoing prolonged treatment and treatment stopped if any elevation in CPK occurs.
Slovenian: Poročali so o resnih primerih miopatije in rabdomiolize; ti so običajno po prekinitvi zdravljenja reverzibilni, vendar je treba pri bolnikih, ki se zdravijo dalj časa, spremljati CPK in zdravljenje pri zvišanju ravni CPK takoj ustaviti.
English: However, the anti-haemorrhagic effect of aminocaproic acid is not necessarily linked to the presence of fibrinolysis in blood shown by the respective tests.
Slovenian: Vendar pa antihemoragični učinek aminokaprojske kisline ni nujno povezan s prisotnostjo fibrinolize v krvi, kar kažejo zadevni testi.
English: • Talk to your doctor before you are given X:If you have poor kidney function.
Slovenian: • Pred začetkom uporabe zdravila X se posvetujte s svojim zdravnikom: če imate okvarjeno delovanje ledvic,
English: • pain or skin death at the injection site
Slovenian: • bolečina ali odmrla koža na mestu injiciranja