FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical data for the cat indicate rapid onset of, and recovery from, sevoflurane anaesthesia.
Slovenian: Klinični podatki za mačko kažejo hiter začetek anestezije in hitro okrevanje po sevofluranski anesteziji.
English: In dogs, the concurrent administration of thiopental, however, may slightly increase sensitivity to adrenaline-induced cardiac arrhythmias.
Slovenian: Vendar lahko sočasna uporaba tiopentala pri psih rahlo zveča občutljivost za srčne aritmije, inducirane z adrenalinom.
English: Due to sevoflurane's low solubility in blood, increasing the concentration may result in rapid haemodynamic changes (dose-dependent decreases in blood pressure) compared to other volatile anaesthetics.
Slovenian: Zaradi majhne topnosti sevoflurana v krvi utegne zviševanje koncentracije povzročiti hitre hemodinamske spremembe (od odmerka odvisno znižanje krvnega tlaka) v primerjavi z drugimi hlapnimi anestetiki.
English: Serum fluoride fell quickly after anaesthesia ended and had returned to baseline by 24 hours post-anaesthesia.
Slovenian: Po končani anesteziji je serumski fluorid hitro padel in se vrnil na izhodiščne vrednosti v 24 urah po anesteziji.
English: The concentration of sevoflurane necessary to maintain anaesthesia is less than that required for induction.
Slovenian: Koncentracija sevoflurana, potrebna za vzdrževanje anestezije, je manjša od tiste, ki je potrebna za njeno uvedbo.
English: Surgical levels of anaesthesia in the healthy dog may be maintained with inhaled concentrations of 3.3 to 3.6% in the presence of premedication.
Slovenian: Kirurške ravni anestezije pri zdravih psih lahko vzdržujemo s koncentracijami 3,3 do 3,6 % v vdihanem zraku ob premedikaciji.
English: Sevoflurane is an inhalational anaesthetic agent, having a light odour, for induction and maintenance of general anaesthesia.
Slovenian: Sevofluran je inhalacijski anestetik blagega vonja za uvod v anestezijo in vzdrževanje splošne anestezije.
English: Halogenated volatile anaesthetics can react with dry carbon dioxide (CO2) absorbents to produce carbon monoxide (CO) that may result in elevated levels of carboxyhaemoglobin in some dogs.
Slovenian: Halogenirani hlapni anestetiki lahko reagirajo s suhimi absorbenti ogljikovega dioksida (CO2), tako da nastane ogljikov monoksid (CO), ki lahko pri nekaterih psih povzroči zvišano raven karboksihemoglobina.
English: If malignant hyperthermia develops, the anaesthetic supply should be interrupted immediately and 100% oxygen administered using fresh anaesthetic hoses and a rebreathing bag.
Slovenian: Če se razvije maligna hipertermija, je treba takoj prekiniti dovajanje anestetika in dati 100-odstotni kisik z uporabo svežih anestezijskih cevi in dihalnega balona.
English: Sevoflurane produces only modest increases in cerebral blood flow and metabolic rate, and has little or no ability to potentiate seizures.
Slovenian: Pri psih sevofluran povzroča le zmerno zvišanje možganskega krvnega pretoka in hitrosti presnove in le malo ali sploh ne krepi napade krčev.
English: The administration of sevoflurane must be individualised based on the dog's or cat's response.
Slovenian: Uporabo sevoflurana je treba prilagoditi posameznemu primeru na podlagi odziva psa ali mačka.
English: Sevoflurane administration adversely affects the autoregulation of renal blood flow in dogs and cats.
Slovenian: Uporaba Sevoflurana neugodno vpliva na avtoregulacijo pretoka krvi skozi ledvice pri psih in mačkah.
English: Intravenous anaesthetics:
Slovenian: Intravenski anestetiki:
English: The administration of general anaesthesia must be individualised based on the dog's or cat's response.
Slovenian: Uporabo splošne anestezije je treba prilagoditi posameznemu primeru na podlagi odziva psa ali mačka.
English: INDICATION(S) For the induction and maintenance of anaesthesia.
Slovenian: INDIKACIJA(E) Za uvedbo in vzdrževanje anestezije.
English: Excessive decreases in blood pressure or respiratory depression may be corrected by decreasing or discontinuing the inspired concentration of sevoflurane.
Slovenian: Čezmerno znižanje krvnega tlaka ali depresijo dihanja lahko popravimo tako, da znižamo vdihano koncentracijo sevoflurana ali ga prenehamo dajati.
English: Hypotension during sevoflurane anaesthesia may result in decreased renal blood flow.
Slovenian: Hipotenzija med sevofluransko anestezijo lahko povzroči zmanjšanje pretoka krvi skozi ledvice.
English: STATEMENT OF ACTIVE SUBSTANCES 100% sevoflurane
Slovenian: NAVEDBA UČINKOVIN(E) 100 % sevofluran
English: Sevoflurane may trigger episodes of malignant hyperthermia in susceptible dogs and cats.
Slovenian: Sevofluran lahko sproži epizode maligne hipertermije pri občutljivih psih in mačkah.
English: Do not use in animals with a known or suspected genetic susceptibility to malignant hyperthermia.
Slovenian: Ne uporabljajte pri živalih z znano genetsko preobčutljivostjo za maligno hipertermijo ali sumom nanjo.
English: Paddling, retching, salivation, cyanosis, premature ventricular contractions and excessive cardiopulmonary depression have been reported very rarely based on post-authorisation spontaneous reporting experience.
Slovenian: Veslanje s tacami, vzdigovanje, slinjenje, cianoza, prezgodnji prekatni utripi in čezmerna kardiopulmonalna depresija so zelo redki neželeni učinki o katerih so poročali po pridobitvi dovoljenja za promet z zdravilom., .
English: Sevoflurane may be used for maintenance anaesthesia following mask induction using sevoflurane or following induction with injectable agents.
Slovenian: Sevofluran lahko uporabljamo za vzdrževalno anestezijo po uvedbi z masko in sevofluranom ali po uvedbi s sredstvi za injiciranje.
English: Dose-dependent respiratory depression is commonly observed while using sevoflurane, therefore respiration should be closely monitored during sevoflurane anaesthesia and the inspired concentration of sevoflurane adjusted accordingly.
Slovenian: Od odmerka odvisna depresija dihanja se pogosto opazi pri uporabi sevoflurana, zato je treba med sevofluransko anestezijo dihanje skrbno spremljati in ustrezno prilagajati koncentracijo sevoflurana v vdihanem zraku.
English: Doses of sevoflurane may need adjustment for geriatric or debilitated animals.
Slovenian: Pri geriatričnih ali izčrpanih živalih bo mogoče treba prilagoditi odmerke sevoflurana.
English: However, there is limited clinical experience of the use of sevoflurane, after propofol induction, in bitches and queens undergoing caesarean section, without any ill effects being detected in either the bitch or queen, or the puppies or kittens.
Slovenian: Vendar so z uporabo sevoflurana po uvodu v anestezijo s propofolom pri psicah in mačkah po carskem rezu na voljo omejene klinične izkušnje, pri tem niso odkrili nikakršnih škodljivih učinkov niti pri psici ali mački niti pri kužkih ali mačjih mladičih.
English: In cases of severe cardiopulmonary depression, discontinue sevoflurane administration, ensure the existence of a patent airway and initiate assisted or controlled ventilation with pure oxygen.
Slovenian: V primerih težke kardiopulmonalne depresije prekinite dovajanje sevoflurana, zagotovite prosto dihalno pot in uvedite asistirano ali kontrolirano ventilacijo s čistim kisikom.
English: In dogs, transient elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), bilirubin and white blood cell counts may occur with sevoflurane, as with the use of other halogenated anaesthetic agents.
Slovenian: Pri psih se tako kot pri uporabi drugih halogeniranih anestetikov, lahko pri sevofluranu pojavi prehodno zvišanje aspartatne aminotransferaze (AST), alaninske aminotransferaze (ALT), laktatne dehidrogenaze (LDH), bilirubina in števila belih krvničk.
English: In common with other inhalational anaesthetics, the MAC of sevoflurane is reduced by the concurrent administration of benzodiazepines and opioids.
Slovenian: Tako kot pri drugih inhalacijskih anestetikih MAC sevoflurana zmanjša sočasna uporaba benzodiazepinov in opioidov.
English: Hypotension, tachypnoea, muscle tenseness, excitation, apnoea, muscle fasciculations and emesis have been reported as very common adverse reactions, based on post-authorisation spontaneous reporting experience.
Slovenian: Hipotenzija, tahipneja, mišična napetost, razdraženost, apneja, mišične fascikulacije in bruhanje so zelo pogosti neželeni učinki, o katerih so poročali po pridobitvi dovoljenja za promet z zdravilom.
English: A minimal amount of sevoflurane is required to be dissolved in the blood before the alveolar partial pressure is in equilibrium with the arterial partial pressure because of the low solubility of sevoflurane in blood (blood/gas partition coefficient at 30°C is 0.63 to 0.69).
Slovenian: Zaradi majhne topnosti sevoflurana v krvi (porazdelitveni koeficient med krvjo in plinom pri 30 °C je 0,63 do 0,69) se mora v krvi raztopiti minimalna količina sevoflurana, preden se alveolarni parcialni tlak uravnovesi z arterijskim parcialnim tlakom.
English: The exothermic reaction that occurs between sevoflurane and CO2 absorbents is increased when the CO2 absorbent becomes desiccated (dried out), such as after an extended period of dry gas flow through the CO2 absorbent canisters.
Slovenian: Eksotermna reakcija, ki nastopi med sevofluranom in absorberji za CO2, postane intenzivnejša, kadar se absorber za CO2 osuši, na primer po daljšem obdobju pretakanja suhega plina skozi posodo z absorberjem za CO2.
English: Anaesthetic-induced bradycardia is commonly observed during sevoflurane anaesthesia.
Slovenian: Z anestezijo inducirana bradikardija se pogosto pojavlja pri sevofluranski anesteziji.
English: In cases of severe cardiopulmonary depression, administration of sevoflurane should be discontinued, the existence of a patent airway ensured, and assisted or controlled ventilation with pure oxygen initiated.
Slovenian: V primerih težke kardiopulmonalne depresije je treba prekiniti dovajanje sevoflurana, zagotoviti prosto dihalno pot in uvesti asistirano ali kontrolirano ventilacijo s čistim kisikom.
English: The use of premedicants does not affect the concentration of sevoflurane required for induction.
Slovenian: Uporaba zdravil za premedikacijo ne vpliva na koncentracijo sevoflurana, ki je potrebna za uvedbo anestezije.
English: In the absence of premedication, inhaled concentrations of sevoflurane in the range of 3.7 to 3.8% will provide surgical levels of anaesthesia in the healthy dog.
Slovenian: Če premedikacije ni, bodo inhalirane koncetracije sevoflurana v mejah 3,7 do 3,8 % pri zdravem psu povzročile kirurške ravni anestezije.
English: Maintenance of anaesthesia:
Slovenian: Vzdrževanje anestezije:
English: The exothermic reaction that occurs between inhalation agents (including sevoflurane) and CO2 absorbents is increased when the CO2 absorbent becomes desiccated, such as after an extended period of dry gas flow through the CO2 absorbent canisters.
Slovenian: Eksotermna reakcija, ki nastopi med inhalacijskimi anestetiki (s sevofluranom vred) in absorberji za CO2, postane intenzivnejša, kadar se absorber za CO2 osuši, na primer po daljšem obdobju pretakanja suhega plina skozi posodo z absorberjem za CO2.
English: Sevoflurane may cause a small increase in intracranial pressure (ICP) under conditions of normocapnia in dogs.
Slovenian: Sevofluran lahko pri psih v normokapniji povzroči majhno zvišanje intrakranialnega tlaka (ICP).
English: • Use a cuffed endotracheal tube when possible for the administration of SevoFlo during maintenance anaesthesia.
Slovenian: • Kadar je možno, uporabljajte za uporabo SevoFlo med vzdrževalno anestezijo endotrahealni tubus z mešičkom.
English: Sevoflurane has a variable effect on heart rate, which tends to increase from baseline at low MAC and fall back with increasing MAC. Sevoflurane causes systemic vasodilation and produces dosedependent decreases in mean arterial pressure, total peripheral resistance, cardiac output and possibly the strength of myocardial contraction and speed of myocardial relaxation.
Slovenian: Sevofluran povzroča sistemsko vazodilatacijo in od odmerka odvisno zmanjšanje srednjega arterijskega tlaka, celotnega perifernega upora, minutnega volumna srca, lahko pa tudi jakosti kontrakcij srčne mišice in hitrosti relaksacije srčne mišice.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT SevoFlo 100% Inhalation vapour, liquid for dogs and cats.
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI SevoFlo 100 % para za inhaliranje, tekočina za pse in mačke.
English: Reaction with barium hydroxide results in a greater production of Compound A than does the reaction with soda lime.
Slovenian: Reakcija z barijevim hidroksidom povzroči nastajanje več spojine A kot reakcija z zmesjo kalcijevega hidroksida z natrijevim ali kalijevim hidroksidom.
English: INDICATION(S) For induction and maintenance of anaesthesia.
Slovenian: INDIKACIJA(E) Za uvod v anestezijo in vzdrževanje anestezije.
English: During the maintenance of anaesthesia, increasing the concentration of sevoflurane produces a dose dependent decrease in blood pressure.
Slovenian: Med vzdrževanjem anestezije povzroči zviševanje koncentracije sevoflurana od odmerka odvisno zniževanje krvnega tlaka.
English: Arterial blood pressure should be monitored at frequent intervals during sevoflurane anaesthesia.
Slovenian: Med sevofluransko anestezijo je treba arterijski krvni tlak spremljati v kratkih presledkih.
English: PHARMACEUTICAL FORM Inhalation vapour, liquid
Slovenian: FARMACEVTSKA OBLIKA Para za inhaliranje, tekočina
English: Medical attention should be sought if irritation persists.
Slovenian: Če draženje trdovratno vztraja, je treba poiskati zdravniško pomoč.
English: In order to maintain renal blood flow, prolonged episodes of hypotension (mean arterial pressure below 60 mmHg) should be avoided in dogs and cats during sevoflurane anaesthesia.
Slovenian: Zaradi vzdrževanja krvnega pretoka skozi ledvice se moramo pri psih in mačkah pod sevofluransko anestezijo izogibati dolgotrajnim epizodam hipotenzije (srednji arterijski tlak pod 60 mmHg).
English: Sevoflurane degradation in soda lime has been shown to increase with temperature.
Slovenian: Dokazali so, da se degradacija sevoflurana v zmesi kalcijevega hidroksida z natrijevim ali kalijevim hidroksidom zvečuje s temperaturo.
English: PHARMACEUTICAL FORM Inhalation vapour, liquid.
Slovenian: FARMACEVTSKA OBLIKA Para za inhaliranje, tekočina.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: inhalation anaesthetic, ATCvet code: QN 01AB08
Slovenian: Oznaka ATCvet: QN 01AB08.
English: PACKAGE LEAFLET: SevoFlo 100% Inhalation vapour, liquid for dogs and cats
Slovenian: NAVODILO ZA UPORABO SevoFlo, 100 % para za inhaliranje, tekočina za pse in mačke
English: Bradycardia can be reversed by the administration of anticholinergics.
Slovenian: Bradikardijo lahko odpravimo z uporabo antiholinergikov.
English: The nephrotoxic potential of certain NSAIDs, when used in the perioperative period, may be exacerbated by hypotensive episodes during sevoflurane anaesthesia.
Slovenian: Epizode hipotenzije med sevofluransko anestezijo lahko poslabšajo nefrotoksični potencial nekaterih nesteroidnih protivnetnih zdravil (NSAID), če jih uporabljamo v perioperativnem obdobju.
English: During maintenance of anaesthesia, increasing the concentration of sevoflurane produces a dosedependent decrease in blood pressure.
Slovenian: Med vzdrževanjem anestezije povzroči zviševanje koncentracije sevoflurana od odmerka odvisno znižanje krvnega tlaka.
English: For operator warnings - read the package leaflet before use.
Slovenian: Pred uporabo preberite navodilo za uporabo.
English: In cats, transient increases in AST and ALT may occur with sevoflurane, however, hepatic enzymes tend to remain within the normal range.
Slovenian: Pri mačkah se lahko pri sevofluranu pojavi prehodno zvišanje aspartatne aminotransferaze (AST), alaninske aminotransferaze (ALT), medtem, ko jetrni encimi ostanejo v normalnem območju.
English: In order to minimise exposure to sevoflurane vapour, the following recommendations are made:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Da bi kar najbolj zmanjšali izpostavitev hlapom sevoflurana, priporočamo naslednje:
English: The possibility of sevoflurane triggering episodes of malignant hyperthermia in susceptible dogs and cats cannot be ruled out.
Slovenian: Čeprav ne poročajo o primerih maligne hipertermije pri psih pod anestezijo s sevofluranom, ni mogoče izključiti možnosti, da bi sevofluran pri dovzetnih psih in mačkah sprožil epizode maligne hipertermije.
English: Induction of anaesthesia:
Slovenian: Uvod v anestezijo:
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil
English: As a result, renal blood flow falls in a linear fashion with increasing hypotension in sevoflurane anaesthetised dogs and cats.
Slovenian: Kot posledica se pri psih in mačkah, anesteziranih s sevofluranom, pretok krvi skozi ledvice zmanjšuje linearno z naraščajočo hipotenzijo.
English: Longduration, low-flow sevoflurane anaesthesia should be avoided due to the risks of Compound A accumulation.
Slovenian: Zaradi nevarnosti kopičenja spojine A se je treba dolgotrajni nizkopretočni sevofluranski anesteziji izogibati.
English: 4.2 Indications for use, specifying the target species
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Za uvod v anestezijo in vzdrževanje anestezije.
English: Symptoms of human overexposure (inhalation) to sevoflurane vapour include respiratory depression, hypotension, bradycardia, shivering, nausea and headache.
Slovenian: Neželeni škodljivi učinki, povezani z uporabo SevoFlo, o katerih najpogosteje poročajo, so bile hipotenzija, nato pa tahipneja, mišična napetost, razdraženost, apneja, mišične fascikulacije in bruhanje.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE BOTTLE
Slovenian: PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI STEKLENICA
English: 22 November 2012 EMA/393905/2006 Rev. 2
Slovenian: 22. novembra 2012 EMA/393905/2006 Rev. 2
English: Regulatory authorities may also perform an inspection of these monitoring systems.
Slovenian: Regulativni organi lahko opravijo pregled teh sistemov spremljanja.
English: However, this can only be done as long as it does not affect the medicine's activity.
Slovenian: Vendar je to dovoljeno le, če ne vpliva na delovanje zdravila.
English: Each company is required to set up systems to monitor the safety of all medicines that it markets.
Slovenian: Vsaka družba mora vzpostaviti sistem spremljanja varnosti vseh zdravil, ki jih trži.
English: Generic medicines are manufactured according to the same quality standards as all other medicines.
Slovenian: Generična zdravila se izdelujejo po enakih standardih kakovosti kot vsa druga zdravila.
English: They may also decide to develop a medicine with a slightly different indication, such as a limited indication that will allow the medicine to be used without a prescription.
Slovenian: Lahko se odločijo tudi za razvoj zdravila z nekoliko drugačno indikacijo, na primer omejeno indikacijo, ki bi omogočala uporabo zdravila brez recepta.
English: This protection applies to new uses of the medicine, such as new indications.
Slovenian: To varstvo se lahko uveljavlja za vse nove uporabe zdravila, na primer za nove indikacije.
English: This type of generic medicine is called a ‘hybrid' medicine, because its authorisation relies in part on the results of tests trials on the reference medicine and in part on new data.
Slovenian: Tovrstna generična zdravila se imenujejo „hibridna“ zdravila, saj je njihova odobritev delno odvisna od rezultatov testnih preskušanj referenčnega zdravila, delno pa od novih podatkov.
English: If the medicine is a hybrid, additional tests may be required, such as the results of clinical trials that test the efficacy of the medicine.
Slovenian: Če je zdravilo hibrid, se lahko zahtevajo dodatni testi, na primer rezultati kliničnih preskušanj, s katerimi se testira učinkovitost zdravila.
English: However, the name of the medicine, its appearance (such as colour or shape) and its packaging can be different from those of the reference medicine.
Slovenian: Vendar pa so lahko ime, videz (npr. barva in oblika) in ovojnina zdravila drugačni kot pri referenčnem zdravilu.
English: Bioequivalence studies are only needed for medicines that are absorbed by the body before being released into the bloodstream, such as medicines that are taken by mouth.
Slovenian: Študije biološke enakovrednosti so potrebne samo za zdravila, ki jih telo absorbira, preden se sprostijo v krvni obtok, na primer peroralna zdravila.
English: A generic manufacturer may choose to use a different form of the active substance, for example the manufacturer can decide to use a ‘hydrochloride' salt of the active substance because this form is more stable.
Slovenian: Izdelovalec generičnega zdravila lahko izbere drugačno obliko zdravilne učinkovine; lahko se na primer odloči, da bo uporabil „hidrokloridno“ sol zdravilne učinkovine, ker je ta oblika obstojnejša.
English: Specifically, a company producing a generic medicine needs to provide information on the quality of the medicine.
Slovenian: Družba, ki proizvaja generično zdravilo, mora predložiti predvsem podatke o kakovosti zdravila.
English: As for all medicines, the safety of generic medicines continues to be monitored after authorisation.
Slovenian: Kot pri vseh zdravilih se varnost generičnih zdravil spremlja tudi po odobritvi.
English: Until the expiry of the use patent, generic medicines can only be marketed for indications that are not patented.
Slovenian: Dokler veljavnost patenta za uporabo ne poteče, se lahko generično zdravilo trži samo za indikacije, ki niso patentirane.
English: Generic medicines that are administered directly into the bloodstream, such as those given directly into a vein by injection or infusion (drip), do not need to be tested for bioequivalence against the reference medicine.
Slovenian: Generičnih zdravil, ki se dajejo neposredno v krvni obtok, na primer zdravil, ki se injicirajo ali infundirajo (kapalno) v veno, ni treba testirati, ali so biološko enakovredna referenčnemu zdravilu.
English: As the reference medicine will have been authorised for several years, information is already available on the efficacy and safety of the active substance(s) it contains.
Slovenian: Ker so referenčna zdravila odobrena že nekaj let, so na voljo podatki o učinkovitosti in varnosti zdravilne(ih) učinkovine (učinkovin), ki jo (jih) zdravilo vsebuje.
English: In most cases, it will also need to supply data from a bioequivalence study to show that the generic medicine produces the same levels of the active substance in the body (whether human or animal) as the reference medicine.
Slovenian: V večini primerov mora predložiti tudi podatke iz študije biološke enakovrednosti, s katero mora dokazati, da se ob jemanju generičnega zdravila v (človekovem ali živalskem) telesu tvori enaka raven zdravilne učinkovine kot pri referenčnem zdravilu.
English: The innovator company benefits from data and market exclusivity under pharmaceutical legislation (typically 10 years from the date of first authorisation).
Slovenian: V skladu s farmacevtsko zakonodajo je družba, ki je razvila inovativno zdravilo, upravičena do podatkovne in tržne zaščite (običajno 10 let od datuma prve odobritve zdravila).
English: When can a generic medicine be developed?
Slovenian: Kdaj se lahko razvije generično zdravilo?
English: A generic medicine is a medicine that is developed to be the same as a medicine that has already been authorised (the ‘reference medicine').
Slovenian: Generično zdravilo je zdravilo, ki je zasnovano tako, da je enako že odobrenemu zdravilu („referenčnemu zdravilu“).