FrancophonIA/ELRC3.0 huggingface dataset:
English: Bromocriptine, dihydroergocryptine and lisuride belong to the class of ergot derived dopamine agonists, which also comprises cabergoline and pergolide.
Slovenian: Bromokriptin, dihidroergokriptin in lizurid pripadajo razredu agonistov dopamina, pridobljenih iz rženega rožička, kamor spadata tudi kabergolin in pergolid.
English: • For bromocriptine, dihydroergocryptine and lisuride:
Slovenian: • Za bromokriptin, dihidroergokriptin in lizurid:
English: At its June 2008 meeting, the CHMP concluded that the amount of evidence on the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
Slovenian: Odbor za zdravila za uporabo v humani medicini je na svojem zasedanju junija 2008 menil, da dokazi o tveganju fibroznih dogodkov, vključno z boleznimi zaklopke, kažejo, da tveganje ni enako pri vseh agonistih dopamina, pridobljenih iz rženega rožička.
English: Ergot-derived dopamine agonists have been associated with an increased risk of fibrotic disorders and valvular heart disease.
Slovenian: Dopaminski agonisti, pridobljeni iz rženega rožička, so povezani s povečanim tveganjem fibroznih motenj in obolenj srčnih zaklopk.
English: In view of the above, the CHMP recommended the maintenance of the marketing authorisation for bromocriptine, dihydroergocryptine and lisuride containing medicinal products with amendments to their product information (Summary of product characteristics and Package leaflet), as outlined below.
Slovenian: Zaradi tega je CHMP priporočil ohranitev dovoljenja za promet z zdravili, ki vsebujejo kabergolin in pergolid, s tem da se dopolnijo informacije o teh zdravilih (povzetek glavnih značilnosti zdravila in navodilo za uporabo), kot je navedeno spodaj:
English: - The CHMP considered the referral made under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide.
Slovenian: 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo bromokriptin, kabergolin, dihidroergokriptin, lizurid in pergolid;
English: For bromocriptine, dihydroergocryptine and lisuride, an increased risk of fibrosis, including cardiac valvulopathy, cannot be excluded.
Slovenian: Pri uporabi bromokriptina, dihidroergokriptina in lizurida, ni mogoče izključiti povečanega tveganja fibroze, vključno z boleznijo srčne zaklopke.
English: Overall, data from spontaneous reports indicate that subjects using carbergoline and pergolide are more at risk for fibrotic events and valvulopathy than subjects using bromocriptine, lisuride or dihydroergocryptine.
Slovenian: Podatki iz spontanih poročil tako kažejo, da so uporabniki karbergolina in pergolida izpostavljeni večjemu tveganju fibroznih dogodkov in bolezni srčne zaklopke kot uporabniki bromokriptina, lizurida ali dihidroergokriptina.
English: However, cases of valvulopathy were reported for bromocriptine, cabergoline, dihydroergocryptine and pergolide, but not for lisuride.
Slovenian: O primerih težav s srčnimi zaklopkami pa so poročali pri uporabi bromokriptina, kabergolina, dihidroergokriptina in pergolida, ne pa tudi lizurida.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
Slovenian: PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
English: For bromocriptine, dihydroergotamine and lisuride, no fibrotic events have been reported by MAHs from clinical trials or observational studies.
Slovenian: Imetniki dovoljenj za promet z zdravili pri uporabi bromokriptina, dihidroergotamina in lizurida v kliničnih preskušanjih ali opazovalnih študijah niso poročali o fibroznih dogodkih.
English: 13 days.
Slovenian: 13 dni.
English: This summary was last updated in June 2007.
Slovenian: Ta povzetek je bil nazadnje posodobljen junija 2007.
English: This contributes to the spread of the disease to other animals.
Slovenian: Slednje prispeva k širjenju bolezni na druge živali.
English: The marketing authorisation was renewed on 29 October 2004.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano dne 29. oktobra 2004.
English: Any unused product or waste materials should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadne snovi je treba odstraniti v skladu z nacionalnimi določili.
English: Information on the prescription status of this product may be found on the label of the bottle.
Slovenian: Informacije o predpisovanju tega izdelka najdete na nalepki na steklenički.
English: It was also shown to prevent diarrhoea following 11 days of treatment.
Slovenian: Izkazalo se je tudi, da prepreči drisko po 11 dneh zdravljenja.
English: Such symptoms can include diarrhoea, visible blood in the faeces, a decline in milk consumption, dehydration, apathy (lack of responsiveness), weakness and collapse.
Slovenian: Takšni simptomi lahko vključujejo drisko, vidne sledi krvi v iztrebkih, manjše uživanje mleka, dehidracijo, apatijo (pomanjkanje odzivnosti), šibkost in kolaps.
English: Users should avoid skin and eye contact with the product and if such contact happens, they should wash the exposed area thoroughly with clean water.
Slovenian: Uporabniki se morajo izogibati stiku zdravila s kožo in očmi; v primeru takšnega stika morajo izpostavljen predel temeljito umiti s čisto vodo.
English: The exact way halofuginone works is unknown.
Slovenian: Natančen način delovanja halofuginona ni znan.
English: Other information about Halocur:
Slovenian: Druge informacije o zdravilu Halocur:
English: In one trial, calves were included from 40 farms.
Slovenian: Ena izmed raziskav je vključevala teleta s 40 kmetij.
English: A number of field trials were performed involving calves from different farms.
Slovenian: Izvedenih je bilo več terenskih raziskav s teleti z različnih kmetij.
English: Halocur should not enter watercourses as this may be dangerous for fish and other aquatic organisms.
Slovenian: Zdravilo Halocur ne sme priti v vodotoke, ker je lahko nevarno za ribe in druge vodne organizme.
English: Protective gloves should be worn while handling the product and hands should be washed after use.
Slovenian: Med rokovanjem z zdravilom je treba nositi zaščitne rokavice, po uporabi pa si je treba umiti roke.
English: In all cases, Halocur is given to the calf by mouth after a feed, not on an empty stomach, once a day for seven consecutive days.
Slovenian: V vseh primerih se zdravilo Halocur daje teletu peroralno po krmi, ne na prazen želodec, enkrat dnevno sedem dni zaporedoma.
English: The European Commission granted a marketing authorisation, valid throughout the European Union for Halocur to Intervet International B.V. on 29 October 1999.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Halocur, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
English: What is the time to allow before milk can be taken from the animal for human consumption?
Slovenian: Koliko časa je potrebno počakati pred uporabo mleka živali za prehrano ljudi?
English: If eye irritation persists, medical advice should be sought.
Slovenian: Če draženje oči ne izgine, je treba poiskati pomoč zdravnika.
English: Halocur should not be administered to calves in cases where diarrhoea has been established for more than 24 hours, or to weak animals.
Slovenian: Zdravilo Halocur se ne sme uporabljati pri teletih v primerih, ko driska traja več kot 24 ur, ali pri šibkih živalih.
English: Halocur can be used:
Slovenian: Zdravilo Halocur se lahko uporablja:
English: Not applicable since the product is only to be used in newborn calves.
Slovenian: Navedba smiselno ni potrebna, ker se zdravilo uporablja samo pri novorojenih teletih.
English: What benefit has Halocur shown during the studies?
Slovenian: Kakšne koristi je zdravilo Halocur izkazalo med raziskavami?
English: What is the risk associated with Halocur?
Slovenian: Kakšna tveganja so povezana z zdravilom Halocur?
English: It also prevents it from forming oocysts, which are formed at a certain stage in the lifecycle of the parasite and are excreted (shed) in the faeces.
Slovenian: Preprečuje tudi tvorjenje oocist, ki nastajajo v določeni stopnji življenjskega cikla zajedavca in se izločajo v iztrebke.
English: They recommended that Halocur be given a marketing authorisation.
Slovenian: Zato je priporočil, da se za zdravilo Halocur odobri dovoljenje za promet.
English: People who handle Halocur repeatedly may develop skin allergies.
Slovenian: Pri ljudeh, ki pogosto rokujejo z zdravilom Halocur, se lahko pojavijo kožne alergije.
English: • to reduce diarrhoea, when it is given in the 24 hours after the onset of diarrhoea.
Slovenian: • za blažitev driske, če se daje v 24 urah po nastopu driske.
English: Why has Halocur been approved?
Slovenian: Zakaj je bilo zdravilo Halocur odobreno?
English: Early treatment in the first 24 to 48 hours after birth was shown to be most beneficial.
Slovenian: Kot najučinkovitejše se je izkazalo zgodnje zdravljenje v prvih 24 do 48 urah po skotitvi.
English: Treatment with the recommended dose of Halocur orally during 7 consecutive days, in calves aged from 4 to 10 days was shown to reduce diarrhoea compared to placebo.
Slovenian: Dokazano je bilo, da zdravljenje s priporočenim odmerkom zdravila Halocur peroralno 7 zaporednih dni pri teletih, starih od 4 do 10 dni, v primerjavi s placebom ublaži drisko.
English: These studies compared treatment with Halocur to placebo.
Slovenian: V teh raziskavah so zdravilo Halocur primerjali s placebom.
English: Clinical signs of Cryptosporidium parvum infection are seen mainly as diarrhoea.
Slovenian: Klinični znaki okužbe s Cryptosporidium parvum se kažejo pretežno kot driska.
English: Halocur contains the active substance halofuginone lactate, which is used against parasitic diseases caused by protozoa.
Slovenian: Zdravilo Halocur vsebuje zdravilno učinkovino halofuginon laktat, ki se uporablja proti zajedavskim boleznim, ki jih povzročajo protozoji.
English: Halocur should be given after feeding.
Slovenian: Zdravilo Halocur je treba dajati po krmi.
English: This is a parasite belonging to the ‘protozoa' family that invades the digestive system causing diarrhoea.
Slovenian: To je zajedavec iz družine protozojev, ki vdre v prebavni sistem in povzroči drisko.
English: The active substance in Halocur, halofuginone lactate, prevents the growth of Cryptosporidium parvum.
Slovenian: Zdravilna učinkovina zdravila Halocur, halofuginon laktat, preprečuje rast Cryptosporidium parvum.
English: Another trial of calves aged from 24 to 48 hours demonstrated that Halocur can prevent diarrhoea due to Cryptosporidium parvum compared with placebo.
Slovenian: Druga raziskava s teleti, starimi od 24 do 48 ur, je pokazala, da zdravilo Halocur v primerjavi s placebom lahko prepreči drisko, ki jo povzroča Cryptosporidium parvum.
English: What is Halocur used for?
Slovenian: Za kaj se zdravilo Halocur uporablja?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Halocur outweigh the risks in the prevention and reduction of diarrhoea due to Cryptosporidium parvum in newborn calves.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je odločil, da so koristi zdravila Halocur pri preprečevanju in zmanjševanju driske, ki jo povzroča Cryptosporidium parvum, pri novorojenih teletih večje od z njim povezanih tveganj.
English: How has Halocur been studied?
Slovenian: Kako je bilo zdravilo Halocur raziskano?
English: What is Halocur?
Slovenian: Kaj je zdravilo Halocur?
English: Halocur is used in newborn calves to prevent or reduce diarrhoea due to an organism called Cryptosporidium parvum.
Slovenian: Zdravilo Halocur se uporablja pri novorojenih teletih za preprečevanje ali blaženje driske, ki jo povzroča organizem Cryptosporidium parvum.
English: • to prevent diarrhoea in farms with a history of cryptosporidiosis (infection with
Slovenian: • za preprečevanje driske na kmetijah, na katerih se je že v preteklosti pojavljala kriptosporidioza (okužba s Cryptosporidium), če se daje novorojenim teletom v prvih 24 do 48
English: Halocur is presented as a clear, yellow solution for administration by mouth.
Slovenian: Zdravilo Halocur je na voljo kot bistra rumena raztopina za peroralno uporabo.
English: Halocur treatment was shown to reduce the level of excretion of Cryptosporidium parvum by the calves and to reduce diarrhoea.
Slovenian: Raziskave so pokazale, da zdravilo Halocur pri teletih zmanjša raven izločanja Cryptosporidium parvum in ublaži drisko.
English: How does Halocur work?
Slovenian: Kako zdravilo Halocur deluje?
English: Symptoms of toxicity may occur if Halocur is administered at twice the recommended dose.
Slovenian: Če se zdravilo Halocur daje v odmerku, ki je dvakrat večji od priporočenega, se lahko pojavijo simptomi toksičnosti.
English: 1 pre-filled syringe (singledose)
Slovenian: 1 napolnjen injekcijski peresnik (enoodmerni)
English: (picture 2).
Slovenian: (slika 2).
English: Date of first authorisation: 27 January 1999 Date of latest renewal: 13 January 2009
Slovenian: Datum prve odobritve: 27. januar 1999 Datum zadnjega podaljšanja: 13. januar 2009
English: • Wash your hands.
Slovenian: • Umijte si roke.
English: • Tilt your head back.
Slovenian: • Nagnite glavo nazaj.
English: Do not drive or use machines until your vision is clear.
Slovenian: Ne vozite ali ne uporabljajte strojev, dokler ne boste jasno videli.
English: For single use only; one container is sufficient to treat both eyes.
Slovenian: Samo za enkratno uporabo; en vsebnik zadostuje za zdravljenje obeh očes.
English: Now turn over>
Slovenian: Obrnite stran >
English: Don't put in any more drops until it's time for your next regular dose.
Slovenian: Kapljic ne vkapajte ponovno, dokler ne bo čas za naslednji redni odmerek.
English: If a drop misses your eye, try again.
Slovenian: Če kapljica zgreši oko, poskusite ponovno.
English: There are no adequate data from the use of emedastine in pregnant women.
Slovenian: Ni ustreznih podatkov o uporabi emedastina pri nosečnicah.
English: Not Known (frequency cannot be estimated from the available data) • General side effects: increased heart rate
Slovenian: Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) • Splošni neželeni učinki: povečana srčna frekvenca
English: It works by reducing the intensity of the allergic reaction.
Slovenian: Deluje tako, da zmanjšuje jakost alergijske reakcije.
English: The recommended dose < see side 1
Slovenian: Priporočeni odmerek <glejte 1. stran
English: • Do not use EMADINE in children under the age of 3 years.
Slovenian: • Zdravila EMADINE ne uporabljajte pri otrocih, mlajših od 3 let.
English: They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Slovenian: Razvrščeni so po organskih sistemih in po pogostnosti v skladu z naslednjim dogovorom: 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) ali neznana pogostnost (ni je mogoče oceniti iz razpoložljivih podatkov).
English: The recommended dose is in adults and children over 3 years: One drop in the eye, twice a day.
Slovenian: Priporočeni odmerek je pri odraslih in otrocih, starejših od 3 let: Ena kapljica v oko dvakrat na dan.
English: In 13 clinical studies involving 696 patients, Emadine was administered one to four times daily in both eyes for up to 42 days.
Slovenian: V 13 kliničnih študijah, v katere je bilo vključenih 696 bolnikov, so zdravilo EMADINE aplicirali enkrat do štirikrat na dan v obe očesi v času do 42 dni.
English: • Make sure you have a mirror handy and wash your hands.
Slovenian: • Pripravite si ogledalo in umijte roke.
English: It is not known whether topical administration to humans could result in sufficient systemic absorption to produce detectable quantities in breast milk.
Slovenian: Ni znano, ali lahko topikalna uporaba zdravila pri ljudeh povzroči zadostno sistemsko absorpcijo, da se v materinem mleku pojavijo merljive količine zdravila.
English: You can carry on taking the drops, unless the effects are serious.
Slovenian: Z uporabo zdravila lahko nadaljujete, razen če so neželeni učinki resni.
English: In clinical trials, approximately 7% of patients experienced an adverse drug reaction associated with the use of Emadine; however, less than 1% of these patients discontinued therapy due to these adverse drug reactions.
Slovenian: V kliničnih preskušanjih je imelo približno 7 % bolnikov neželene učinke ob uporabi zdravila Emadine, vendar je manj kot 1 % teh bolnikov prenehalo z zdravljenjem zaradi omenjenih neželenih učinkov.
English: • if you are allergic to emedastine or any of the other ingredients of this medicine listed in section 6.
Slovenian: • če ste alergični na emedastin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Allergic conjunctivitis.
Slovenian: Alergijski konjunktivitis.
English: Approximately 44% of an oral dose is recovered in the urine over 24 hours, with only 3.6% of the dose excreted as parent drug substance.
Slovenian: Približno 44 % peroralnega odmerka se izloči v urin v 24 urah, od tega le 3,6 % v obliki matične zdravilne učinkovine.
English: Belgium.
Slovenian: Belgija.
English: The human oral bioavailability of emedastine is approximately 50% and maximum plasma concentrations were achieved within one-two hours after dosing.
Slovenian: Peroralna biološka uporabnost emedastina pri človeku je približno 50 %, največja plazemska koncentracija pa je dosežena v eni do dveh urah po uporabi.
English: EMADINE should not be used for longer than 4 weeks after first opening.
Slovenian: Zdravila EMADINE ne smete uporabljati dlje kot 4 tedne po prvem odprtju.
English: Studies with emedastine have not shown effects on adrenergic, dopaminergic, and serotonin receptors.
Slovenian: Študije z emedastinom niso pokazale učinkov na adrenergične, dopaminergične in serotoninske receptorje.
English: Two primary metabolites, 5-and 6-hydroxyemedastine, are excreted in the urine as both free and conjugated forms.
Slovenian: Dva primarna presnovka, 5-in 6-hidroksiemedastin, se izločata z urinom tako v prosti kot v konjugirani obliki.
English: No human fertility data are available.
Slovenian: Podatkov o učinkih na plodnost pri človeku ni na razpolago.
English: Pharmacotherapeutic group: decongestants and antiallergics; other antiallergics, ATC code: S01G X
Slovenian: Farmakoterapevtska skupina: dekongestivi in protialergijska zdravila; druga protialergijska zdravila, oznaka ATC: S01G X 06
English: • If you use drops in both eyes, repeat the steps for your other eye.
Slovenian: • Če uporabljate kapljice na obeh očesih, ponovite te korake tudi na drugem očesu.
English: Studies in animals have shown no evidence of impaired fertility (See Section 5.3).
Slovenian: Študije na živalih niso pokazale škodljivih učinkov na plodnost (glejte poglavje 5.3).
English: EMADINE has not been studied in clinical trials beyond six weeks.
Slovenian: Zdravila EMADINE niso raziskovali v kliničnih preskušanjih, daljših od šest tednov.
English: If you are using other eye drops, leave at least 10 minutes between using EMADINE and the other drops.
Slovenian: Če uporabljate tudi druge kapljice za oko, počakajte najmanj 10 minut med uporabo zdravila EMADINE in drugih kapljic.
English: The elimination half-life of topical emedastine is ten hours.
Slovenian: Njegov razpolovni čas izločanja pri topikalni uporabi je deset ur.
English: • If you wear contact lenses please see section ‘EMADINE contains benzalkonium chloride below'.
Slovenian: • Če nosite kontaktne leče, glejte poglavje ‘Zdravilo EMADINE vsebuje benzalkonijev klorid' v nadaljevanju.
English: Emedastine is absorbed systemically, as are other topically administered drug substances.
Slovenian: Emedastin se absorbira sistemsko tako kot tudi druge zdravilne učinkovine, uporabljene topikalno.
English: You must throw away the bottle four weeks after you first opened it, to prevent infections.
Slovenian: Kapalni vsebnik morate zavreči štiri tedne po prvem odprtju, da preprečite okužbe.
English: • EMADINE is not recommended for use in patients with kidney or liver problems.
Slovenian: • Uporabe zdravila EMADINE ne priporočamo bolnikom, ki imajo težave z ledvicami ali jetri.
English: EMADINE is a medicine for the treatment of seasonal allergic conjunctivitis of the eye (allergic conditions of the eye).
Slovenian: EMADINE je zdravilo za zdravljenje sezonskega alergijskega konjunktivitisa oči (alergijska bolezen oči).
English: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain.
Slovenian: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Španija.
English: Some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness as well as swelling of the surface of your eye.
Slovenian: Nekatere snovi (alergeni), kot so cvetni prah, hišni prah ali živalska dlaka, lahko povzročijo alergijske reakcije s srbenjem, pordelostjo in otekanjem površine očesa.
English: • If your doctor has told you to use drops in both eyes, repeat the steps for your other eye-using the same container.
Slovenian: • Če vam je zdravnik naročil, da uporabljajte kapljice na obeh očesih, ponovite te korake tudi na drugem očesu z uporabo istega vsebnika.
English: Symptomatic treatment of seasonal allergic conjunctivitis.
Slovenian: Simptomatsko zdravljenje sezonskega alergijskega konjunktivitisa.
English: Since EMADINE contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
Slovenian: Ker zdravilo EMADINE vsebuje benzalkonijev klorid, je pri njegovi pogosti ali daljši uporabi potrebno skrbno spremljanje bolnika.
English: Do not use a double dose to make up for the one missed.
Slovenian: Ne uporabite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Do not use any sealed containers from a foil wrapper that was opened more than a week ago.
Slovenian: Ne uporabljajte zaprtih vsebnikov iz folijske vrečke, ki ste jo odprli pred več kot enim tednom.
English: Emedastine difumarate demonstrated low acute toxicity in a number of species by various routes of administration.
Slovenian: Emedastinijev difumarat je pokazal majhno akutno toksičnost pri več živalskih vrstah in pri različnih poteh uporabe.
English: You will need to snap it apart where it joins the others (picture 1).
Slovenian: kjer se stika z drugimi (slika 1).
English: Emedastine is a potent selective and topically effective histamine H1 antagonist (Ki = 1.3 nM).
Slovenian: Emedastin je močan, selektiven in topikalno učinkovit antagonist histaminskih receptorjev H1 (Ki = 1,3 nM).
English: This medicine contains 0.5 mg or 1 mg benzalkonium chloride in each 5 or 10 ml, which are equivalent to 0.1 mg/ml.
Slovenian: To zdravilo vsebuje 0,5 mg ali 1 mg benzalkonijevega klorida v 5 ali 10 ml, kar je enako 0,1 mg/ml.
English: The dose is one drop of EMADINE to be applied to the affected eye(s) twice daily.
Slovenian: Odmerek je ena kapljica zdravila EMADINE v prizadeto oko (oči) dvakrat na dan.
English: Turn the page for more advice
Slovenian: Za dodatne informacije obrnite stran
English: Only use the drops in your eyes.
Slovenian: Kapljice uporabljajte le za oko.
English: For ocular use.
Slovenian: Za okularno uporabo.
English: The preservative in EMADINE, benzalkonium chloride, may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Slovenian: Konzervans v zdravilu EMADINE, benzalkonijev klorid, se lahko absorbira v mehke kontaktne leče in lahko spremeni barvo kontaktnih leč.
English: What EMADINE is and what it is used for
Slovenian: Kaj je zdravilo EMADINE in za kaj ga uporabljamo
English: 5.3 Preclinical Safety Data
Slovenian: 5.3 Predklinični podatki o varnosti
English: Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.