FrancophonIA/ELRC3.0 huggingface dataset:
English: Unit dose syringe-shaped applicators (clear siliconised cyclic olefin copolymer (COC)) containing 0.3 ml or 0.9 ml of product, closed with a polymer cap and placed in individual plastic blisters.
Slovenian: 0,3 ml ali 0,9 ml tekočine, zaprt s polimernim pokrovčkom, v posamičnih plastičnih omotih.
English: Oral ingestion of the veterinary medicinal product resulted in common to uncommon vomiting, hypersalivation and/or in transient neurological signs such as ataxia, disorientation, apathy and pupil dilation in safety studies.
Slovenian: Zaužitje zdravila je v varnostnih študijah pogosto do občasno povzročilo bruhanje, povečano slinjenje in ali prehodne nevrološke znake kot so ataksija, dezorientacija, apatija in razširjene zenice.
English: Cats <2.5 kg Cats 2.5-7.5 kg
Slovenian: Mačke < 2,5 kg Mačke 2,5-7,5 kg
English: Pull back the plunger slightly, twist and pull off the cap.
Slovenian: Bat potegnite rahlo nazaj, zavrtite in odtrgajte vrh aplikatorja.
English: Digestive tract and/or neurological disorders may result following an accidental oral ingestion of the veterinary medicinal product (see section 4.5).
Slovenian: Kot posledica nenamernega zaužitja zdravila se lahko pojavijo prebavne in nevrološke motnje (glejte poglavje 4.5).
English: For topical application onto the skin (spot-on).
Slovenian: Nanos na kožo (spot on).
English: Do not use in sick or convalescent animals.
Slovenian: Ne uporabite pri bolnih živalih ali živalih med okrevanjem po bolezni.
English: Digestive tract and/or neurological disorders may result following an accidental oral ingestion of the veterinary medicinal product (see section ‘Special precautions for use in animals' under SPECIAL WARNINGS).
Slovenian: Kot posledica nenamernega zaužitja zdravila se lahko pojavijo prebavne in nevrološke motnje (glejte poglavje Posebna opozorila za vsako ciljno živalsko vrsto, pod POSEBNA OPOZORILA).
English: Use a pair of scissors to cut the blister along the dotted line, then pull the lid away.
Slovenian: S škarjami zarežite vzdolž preluknjane črte na pretisnem omotu in odstranite pokrov.
English: - The product can be used as part of a treatment strategy for the control of flea allergy dermatitis
Slovenian: - Zdravilo je del zdravljenja in preprečevanja alergijskih dermatitisov, ki jih povzroča bolhavost
English: Part the hair on the midline of the neck, between the base of the skull and the shoulder blades until the skin is visible.
Slovenian: - Na sredini vratu med zatiljem in lopaticami, razmaknite dlako da postane koža vidna.
English: infestation may nevertheless harbour a high proportion of juvenile worms, which are not susceptible to the product; therefore a post-treatment follow-up is recommended in case of such infestations.
Slovenian: Nekatere mačke, ki so v patentnem obdobju infestacije z Joyeuxiella spp., lahko vseeno imajo velik delež nezrelih oblik, ki niso dovzetne za to zdravilo, zato je v primeru tovrstnih okužb po zdravljenju priporočljivo spremljanje živali.
English: - Treatment of notoedric mange (Notoedres cati).
Slovenian: - Zdravljenje garjavosti (Notoedres cati).
English: Parasite resistance to any particular class of antiparasitic drug may develop following frequent use of a compound of that class.
Slovenian: Pri pogosti uporabi antiparazitikov tega razreda lahko pride do odpornosti parazitov na učinkovino.
English: In vitro metabolism assays and in vivo studies have demonstrated that there are no pharmacodynamic or pharmacokinetic interactions between fipronil, (S)-methoprene, eprinomectin and praziquantel.
Slovenian: In vitro študije metabolizma ter in vivo študije so pokazale, da med fipronilom, (S)-metoprenom,
English: 48 hours.
Slovenian: Odpravi klope v 48 urah.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: Nematodes - Treatment of infestations with gastrointestinal nematodes (L3, L4 larvae and adults of Toxocara cati, adults of Toxascaris leonina , L4 larvae and adults of Ancylostoma tubaeforme and
Slovenian: Nematodi - Zdravljenje infestacij z gastrointestinalnimi nematodi (L3, L4 ličinke in odrasli paraziti Toxocara cati, odrasle oblike Toxascaris leonina, L4 ličinke in odrasli paraziti Ancylosotma tubaeforme in Ancylostoma ceylanicum, in odrasli paraziti Ancylostoma brazilienze).
English: A temporary clumping or spiking of the hair and mild and transient skin reactions at the application site (itching, hair loss) have been commonly observed at the application site after treatment in clinical studies.
Slovenian: NEŽELENI UČINKI Začasna zlepljenost dlake ter blage in prehodne reakcije na koži (srbečica, izpadanje dlake) so se po podatkih iz kliničnih študij pogosto pojavili na mestu nanosa.
English: Unused applicators must be stored in the intact blister package.
Slovenian: Neporabljene aplikatorje shranjujte v nepoškodovanih omotih.
English: - Treatment of infestations with feline lungworms (L3 larvae, L4 larvae and adults of
Slovenian: - Zdravljenje infestacij z mačjimi pljučnimi črvi (L3 ličinke, L4 ličinke in odrasli
English: Select the appropriate applicator size for the weight of the cat.
Slovenian: Izbira primerne velikosti aplikatorja mora temeljiti na telesni masi zdravljene živali.
English: Children should not be allowed to play with treated animals during this period.
Slovenian: Otroci se ne smejo igrati z zdravljeno živaljo, dokler ni mesto nanosa suho.
English: Keep the unused applicator in the intact blister.
Slovenian: Neporabljen aplikator shranjujte v nepoškodovanem omotu.
English: Praziquantel (mg)
Slovenian: prazikvantel (mg)
English: Eprinomectin (mg)
Slovenian: Eprinomektin (mg)
English: Temporary excessive salivation was commonly observed following licking the application site after treatment in clinical trials.
Slovenian: Pogosto se je v kliničnih poskusih pojavilo prehodno povečano slinjenje, če je mačka lizala mesto nanosa zdravila.
English: PACKAGE LEAFLET: BROADLINE spot-on solution for cats < 2.5 kg BROADLINE spot-on solution for cats 2.5-7.5 kg
Slovenian: BROADLINE kožni nanos, raztopina za mačke < 2,5 kg BROADLINE kožni nanos, raztopina za mačke 2,5-7,5 kg
English: 24.9 mg
Slovenian: 24,9 mg fipronil
English: Special precautions for use in animals:
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto:
English: Pull back the plunger slightly, twist and pull off the cap. Part the hair on the midline of the neck, between the base of the skull and the shoulder blades until the skin is visible.
Slovenian: Na sredini vratu med zatiljem in lopaticami, razmaknite dlako, da postane koža vidna.
English: Spot-on use.
Slovenian: NAVODILO ZA UPORABO
English: Muscle tremors have been reported in very rare cases based on post marketing safety experience.
Slovenian: Pri spremljanju varnosti po prihodu zdravila na trg je bil v zelo redkih primerih zaznan mišični tremor.
English: Cardboard box containing 1, 3, 4, 6 or 15 applicator(s) (0.9 ml each).
Slovenian: Kartonska škatla z 1, 3, 4, 6 ali 15 aplikatorji (vsak po 0,9 ml).
English: Ancylostoma ceylanicum, and adults of Ancylostoma brazilienze).
Slovenian: Toxocara cati, odrasle oblike Toxascaris leonina, L4 ličinke in odrasli paraziti Ancylosotma tubaeforme in Ancylostoma ceylanicum, in odrasli paraziti Ancylostoma brazilienze).
English: Use the applicator size adapted to the weight of the cat.
Slovenian: Uporabite aplikator, ki ustreza telesni masi zdravljene živali.
English: Cardboard box containing 1, 3, 4 or 15 applicator(s) (0.3 ml each).
Slovenian: Kartonska škatla z 1, 3, 4 ali 15 aplikatorji (vsak po 0,3 ml).
English: However, as a precaution, it is not recommended to bath animals within 2 days after treatment.
Slovenian: Kot previdnosti ukrep ni priporočljivo kopanje živali do
English: Fipronil
Slovenian: OVOJNINAH
English: Cardboard box containing 1, 3, 4, 6 or 15 unit dose applicator(s) of 0.9 ml each.
Slovenian: Kartonska škatla z 1, 3, 4, 6 ali 15 aplikator(ji), vsak po 0,9 ml.
English: Cat weight
Slovenian: Telesna masa mačke
English: Cestodes - Treatment of infestations with tapeworms (Dipylidium caninum, Taenia taeniaeformis,
Slovenian: Cestodi - Zdravljenje infestacij s trakuljami (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis, Joyeuxiella pasqualei (odrasli), Joyeuxiella fuhrmanni (odrasli)).
English: Cardboard box containing 1, 3, 4 or 15 unit dose applicator(s) of 0.3 ml each.
Slovenian: Kartonska škatla z 1, 3, 4 ali 15 aplikator(ji), vsak po 0,3 ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH
English: Although the product may be safely administered to cats infected with adult heartworms, no therapeutic effect against adult Dirofilaria immitis has been established.
Slovenian: Mačke, infestirane z odraslimi srčnimi glistami, so brez pojava neželenih učinkov prenašale do
English: Special warnings for each target species: Avoid animals licking each other following treatment.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Med dajanjem zdravila je prepovedano kaditi, piti ali jesti.
English: Elimination of ticks within
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: It is available as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).
Slovenian: Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije v veno, 100 mg/ml).
English: The full EPAR for Levetiracetam Sun can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Levetiracetam Sun je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • partial-onset seizures with or without generalisation in patients from four years of age;
Slovenian: • napadov parcialnega izvora z generalizacijo ali brez nje pri bolnikih, starejših od štirih let;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Sun on 14 December 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Levetiracetam Sun , veljavno po vsej Evropski uniji, odobrila dne 14. decembra 2011.
English: This helps Levetiracetam Sun to stabilise electrical activity in the brain and prevent seizures.
Slovenian: To omogoča zdravilu Levetiracetam Sun, da stabilizira električno aktivnost v možganih in prepreči napade.
English: For more information about treatment with Levetiracetam Sun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Levetiracetam Sun preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: EPAR summary for the public levetiracetam
Slovenian: Povzetek EPAR za javnost levetiracetam
English: This means that Levetiracetam Sun is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Keppra.
English: Because Levetiracetam Sun is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Levetiracetam Sun generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Sun.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Levetiracetam Sun.
English: What are the benefits and risks of Levetiracetam Sun?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Levetiracetam Sun?
English: 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 Levetiracetam Sun.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Levetiracetam Sun, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe
English: Other information about Levetiracetam Sun
Slovenian: Druge informacije o zdravilu Levetiracetam Sun
English: Levetiracetam Sun is a ‘generic medicine'.
Slovenian: Levetiracetam Sun je „generično zdravilo“.
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam Sun has been shown to have comparable quality and to be bioequivalent to Keppra.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Levetiracetam Sun primerljivo raven kakovosti kot zdravilo Keppra ter da mu je biološko enakovredno.
English: In patients aged between four and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Slovenian: Pri bolnikih od četrtega do 17. leta starosti, ki tehtajo manj kot 50 kg, je začetni odmerek 10 mg/kg telesne mase dvakrat dnevno, ki ga je mogoče povečati vse do 30 mg/kg telesne mase dvakrat dnevno.
English: The Committee recommended that Levetiracetam Sun be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Levetiracetam Sun odobri dovoljenje za promet.
English: The use of Levetiracetam Sun infusion should be temporary.
Slovenian: Infuzije zdravila Levetiracetam Sun je treba uporabljati le začasno.
English: Levetiracetam Sun is used as an alternative for patients when oral treatment is temporarily not feasible.
Slovenian: Zdravilo Levetiracetam Sun se uporablja kot alternativno zdravilo pri bolnikih, pri katerih peroralno zdravljenje začasno ni možno.
English: Levetiracetam Sun can also be used as an add-on to other anti-epileptic medicines to treat:
Slovenian: Zdravilo Levetiracetam Sun se lahko uporablja kot dopolnilno zdravljenje k drugim zdravilom proti epilepsiji za zdravljenje:
English: When Levetiracetam Sun is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Slovenian: Kadar se zdravilo Levetiracetam Sun dodaja drugemu zdravilu proti epilepsiji, je začetni odmerek pri bolnikih, starejših od 12 let, ki tehtajo več kot 50 kg, 500 mg dvakrat dnevno.
English: Levetiracetam Sun can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Slovenian: Zdravilo Levetiracetam Sun se lahko uporablja kot samostojno zdravilo pri bolnikih, starejših od 16 let, pri katerih so na novo odkrili epilepsijo, za zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje.
English: Levetiracetam Sun is a medicine that contains the active substance levetiracetam.
Slovenian: Levetiracetam Sun je zdravilo, ki vsebuje zdravilno učinkovino levetiracetam.
English: The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1,500 mg twice a day.
Slovenian: Odmerki se lahko glede na bolnikov odziv še naprej povečujejo v dvotedenskih presledkih do največjega odmerka 1 500 mg dvakrat dnevno.
English: When Levetiracetam Sun is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Slovenian: Kadar se zdravilo Levetiracetam Sun uporablja samostojno, znaša začetni odmerek 250 mg dvakrat dnevno, po dveh tednih jemanja pa se poveča na 500 mg dvakrat dnevno.
English: The active substance in Levetiracetam Sun, levetiracetam, is an anti epileptic medicine.
Slovenian: Zdravilna učinkovina zdravila Levetiracetam Sun, levetiracetam, je zdravilo proti epilepsiji.
English: Why has Levetiracetam Sun been approved?
Slovenian: Zakaj je bilo zdravilo Levetiracetam Sun odobreno?
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Keppra,
English: What is Levetiracetam Sun used for?
Slovenian: Za kaj se zdravilo Levetiracetam Sun uporablja?
English: No additional studies in patients were needed as Levetiracetam Sun is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Keppra.
Slovenian: Ker je zdravilo Levetiracetam Sun generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Keppra, niso bile potrebne nobene dodatne študije.
English: What is Levetiracetam Sun?
Slovenian: Kaj je zdravilo Levetiracetam Sun?
English: How has Levetiracetam Sun been studied?
Slovenian: Kako je bilo zdravilo Levetiracetam Sun raziskano?
English: How is Levetiracetam Sun used?
Slovenian: Kako se zdravilo Levetiracetam Sun uporablja?
English: How does Levetiracetam Sun work?
Slovenian: Kako zdravilo Levetiracetam Sun deluje?
English: 1 bottle + 1 oral syringe + 1 bottle adapter
Slovenian: 1 steklenica + 1 odmerna brizga + 1 nastavek za plastenko
English: Oral suspension Oral use bottle (glass)
Slovenian: Peroralna uporaba steklenica (steklo)
English: 50 mg/ml
Slovenian: 50 mg/ml Peroralna suspenzija
English: This is very rare.
Slovenian: To je zelo redko.
English: Some patients have had:
Slovenian: Nekateri bolniki so imeli:
English: Take your next dose the next day at the usual time.
Slovenian: Vzemite naslednji odmerek naslednji dan ob običajnem času.
English: This difference was largely accounted for by weight.
Slovenian: To razliko so pretežno pripisovali teži.
English: In some cases manifestations of toxicity have occurred.
Slovenian: V nekaterih primerih so se pojavile manifestacije toksičnosti.
English: This medicine may affect your judgment or co-ordination.
Slovenian: To zdravilo lahko vpliva na vašo presojo ali koordinacijo.
English: Kölblgasse 8-10 A-1030 Wien Austria
Slovenian: Kölblgasse 8-10 A-1030 Wien Avstrija
English: However, data on maintenance of effect is limited.
Slovenian: Vendarle pa so podatki o vzdrževanju učinka omejeni.
English: It is important that you keep taking your medicine.
Slovenian: Pomembno je, da nadaljujete z jemanjem vašega zdravila.
English: • have suicidal thoughts or want to harm your self.
Slovenian: • imate samomorilne misli ali se želite poškodovati.
English: No specific antidote is known.
Slovenian: Specifični antidot ni znan.
English: It has not been established whether there is an effect on achieving normal adult height.
Slovenian: Niso dokazali, ali obstaja vpliv na doseganje normalne telesne višine odraslega.
English: An interaction could occur with:
Slovenian: Medsebojno delovanje se lahko pojavi z:
English: Adults - All indications: The recommended dose may be increased or decreased.
Slovenian: Odrasli - vse indikacije: Priporočeni odmerek je možno znižati ali zvišati.
English: • have heart problems
Slovenian: • imate težave s srcem,
English: This is usual because an improvement in depressive symptoms may not occur until after the first few weeks.
Slovenian: To je običajno, saj se izboljšanje depresivnih simptomov lahko pojavi šele po prvih nekaj tednih.
English: This risk persists until improvements of your illness occurs.
Slovenian: Tveganje ostaja vse dokler ne pride do izboljšanja vaše bolezni.
English: OTHER (the days of the week will be printed on the foil in abbreviated form).
Slovenian: DRUGI PODATKI (dnevi tedna bodo natiskani na foliji v skrajšani obliki)
English: The usual dose is:
Slovenian: Običajen odmerek je:
English: Two years.
Slovenian: 2 leti.
English: Toxicological Studies:
Slovenian: Toksikološke raziskave:
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Slovenian: Zdravilo je odobreno v državah članicah EEA z naslednjimi imeni:
English: D-61350 Bad Homburg Germany
Slovenian: D-61350 Bad Homburg Nemčija
English: These patients had no prior episodes of hypomania/mania.
Slovenian: Ti bolniki niso imeli predhodnih epizod hipomanije/manije.
English: This medicine may affect the way some other medicines work (interaction).
Slovenian: To zdravilo lahko vpliva na način delovanja drugih zdravil ( medsebojno delovanje).
English: Athens-Lamia, 145 64 Kifissia, GREECE
Slovenian: Athens-Lamia, 145 64 Kifissia, GRČIJA
English: S-16927 Solna, SWEDEN
Slovenian: S-16927 Solna, ŠVEDSKA
English: Clinical monitoring is recommended.
Slovenian: Priporočamo klinično spremljanje.
English: Information collected to date does not indicate a increased risk when used during pregnancy.
Slovenian: Podatki, zbrani do danes, ne kažejo na večje tveganje ob uporabi med nosečnostjo.
English: Cardiac and vital signs monitoring are recommended, along with general symptomatic and supportive measures.
Slovenian: Priporočamo spremljanje srčnega delovanja in vitalnih znakov, skupaj s splošnimi simptomatskimi in podpornimi ukrepi.
English: • Do not stop taking your medicine without asking your doctor first, even when you start to feel better.
Slovenian: • Ne prenehajte jemati zdravila, ne da bi se prej posvetovali s svojim zdravnikom, tudi ko se začnete počutiti bolje.
English: Dyspnoea may be the only preceding symptom.
Slovenian: Dispneja je lahko edini predhodni simptom.
English: Read the leaflet for more information.
Slovenian: Za več informacij preberite tudi navodilo.
English: This medicine is used to treat the following conditions:
Slovenian: To zdravilo se uporablja za zdravljenje naslednjega:
English: This finding would appear to be supported by clinical findings.
Slovenian: Zdi se, da so ta izsledek podprli klinični izsledki.
English: • are taking diuretics (water tablets), especially when you are elderly;
Slovenian: • jemljete diuretike (tablete za odvajanje vode), še zlasti, če ste starejši;
English: Greece: Ladose
Slovenian: Grčija: Ladose
English: This should be borne in mind when starting or stopping treatment.
Slovenian: To je treba ob začetku ali zaključku zdravljenja upoštevati.
English: Three years.
Slovenian: 3 leta.
English: However, for long-term efficacy no conclusion can be drawn.
Slovenian: Vendar pa na dolgoročno učinkovitost še ne moremo sklepati.
English: Excretion is mainly (about 60%) via the kidney.
Slovenian: Izloča se predvsem (približno 60 %) preko ledvic.
English: However, definitive conclusions on efficacy and duration of treatment cannot be drawn from these studies.
Slovenian: Vendar pa o učinkovitosti in trajanju zdravljenja iz teh študij dokončno ne moremo sklepati.
English: • the CHMP considered the referral made under Article 6(12) of Commission Regulation EC No 1084/2003, for Prozac and associated names (see Annex I),
Slovenian: • CHMP je preučil napotitev, pripravljeno po členu 6(12) Uredbe Komisije ES Št. 1084/2003, za zdravilo Prozac in z njim povezanih imen (glejte Dodatek I);
English: 3991 RA Houten The Netherlands
Slovenian: 3991 RA Houten Nizozemska
English: SAFETY ISSUES
Slovenian: VPRAŠANJA GLEDE VARNOSTI
English: In addition, there is a possibility of an increased risk of suicidal behaviour in young adults.
Slovenian: Poleg tega je pri mladih odraslih tveganje za samomorilno vedenje večje.
English: The possibility of a delay in puberty cannot be ruled out (see sections 5.3 and 4.8).
Slovenian: Ne moremo izključiti možnosti zaostanka v puberteti (glejte poglavji 5.3 in 4.8).
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PROZAC AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA PROZAC IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: In long term studies (three short term studies extension phase and a relapse prevention study) efficacy has not been shown.
Slovenian: V dolgotrajnih študijah (podaljšana faza treh kratkotrajnih študij in študija preprečevanja relapsa) učinkovitosti niso pokazali.
English: • Swallow the capsules with a drink of water.
Slovenian: • Kapsule pogoltnite s požirkom vode.
English: The bioavailability is not affected by food intake.
Slovenian: Vnos hrane ne vpliva na biološko uporabnost.