FrancophonIA/ELRC3.0 huggingface dataset:
English: For cats more than 12.5 kg, use a combination of two pipettes that most closely matches the body weight.
Slovenian: Za mačke s telesno maso nad 12,5 kg uporabite kombinacijo dveh kapalk, ki se najbolj približa telesni masi.
English: In case of contact with the eyes, immediately rinse thoroughly with water.
Slovenian: V kolikor pride zdravilo v stik z očmi, ga takoj temeljito sperite z vodo.
English: Therefore prior to application of Bravecto Plus for the concurrent prevention of infection with adult D. immitis, the advice provided in section 4.4 should be considered.
Slovenian: Zato je treba pred uporabo zdravila Bravecto Plus za sočasno preventivo infekcije z odraslimi D. immitis upoštevati nasvet iz poglavja 4.4.
English: Fluralaner is a potent inhibitor of parts of the arthropod nervous system by acting antagonistically on ligand-gated chloride channels (GABA-receptor and glutamate-receptor).
Slovenian: Fluralener je močan inhibitor delov živčnega sistema artropodov s svojim antagonističnim delovanjem na GABA receptor in na receptor glutamata.
English: Rotate cap (cap cannot be removed).
Slovenian: Zavrtite zaporko (zaporke ni mogoče odstraniti).
English: Each ml of solution contains 280 mg fluralaner and 14 mg moxidectin.
Slovenian: 1 ml raztopine vsebuje fluralaner 280 mg in moksidektin 14 mg.
English: Unit dose pipette made of laminated aluminium/polypropylene foil closed with a high-density polyethylene (HDPE) cap and packed in a laminated aluminium foil sachet.
Slovenian: Merilna kapalka iz laminirane aluminijasto/polipropilenske folije zaprta s HDPE zaporko in pakirana v vrečico iz laminirane aluminijaste folije.
English: Oral uptake of the product at the maximum recommended dose of 93 mg fluralaner + 4.65 mg moxidectin/kg body weight induced some self-limiting salivation or single incidences of vomiting immediately after administration.
Slovenian: Peroralno zaužitje zdravila v največjem priporočenem odmerku 93 mg fluralanerja + 4,65 mg moksidektina/kg telesne mase je sprožilo slinjenje, ki je samo po sebi prenehalo, ali posamezne primere bruhanja takoj po dajanju.
English: Each pipette delivers:
Slovenian: Vsaka kapalka vsebuje:
English: For cats with, or at risk from, mixed parasitic infestations by ticks or fleas and ear mites, gastrointestinal nematodes or heartworm.
Slovenian: Za mačke, ki imajo ali so v nevarnosti, da zbolijo zaradi mešanih parazitarnih infestacij s klopi ali bolhami in ušesnimi garjami, ter infekcij z gastrointestinalnimi nematodi ali srčnimi glistami.
English: For the treatment of infestations with ear mites (Otodectes cynotis).
Slovenian: Za zdravljenje infestacij z ušesnimi garjami (Otodectes cynotis).
English: Moxidectin (mg)
Slovenian: Moksidektin (mg)
English: Moxidectin is slowly eliminated from plasma (t1/2 = 26 days) and excreted in faeces and to a very low extent in urine.
Slovenian: Moksidektin se počasi izloča iz plazme (t1/2 = 26 dni) v fecesu in v zelo majhni količini v urin.
English: The product should not be used by persons with a hypersensitivity to the active substance or to any of the excipients (see contraindications, section 5).
Slovenian: Zdravila ne smejo uporabljati osebe s preobčutljivostjo za učinkovino ali katerokoli pomožno snov (glejte Kontraindikacije, poglavje 5).
English: Cats in areas endemic for heartworm (or those which have travelled to endemic areas) may be infected with adult heartworms.
Slovenian: Mačke na področjih, ki so endemična za srčne gliste (ali mačke, ki so potovala na taka področja), so lahko okužene z odraslimi srčnimi glistami.
English: Step 1: Immediately before use, open the sachet and remove the pipette.
Slovenian: Prvi korak: Neposredno pred uporabo odprite vrečko in izvlecite kapalko.
English: Put on gloves.
Slovenian: Nataknite si rokavice.
English: Step 2: The cat should be standing or lying with its back horizontal for easy application.
Slovenian: Drugi korak: Žival naj med dajanjem stoji ali leži, hrbet pa naj bo vodoraven.
English: Seek further veterinary examination (i.e. otoscopy) 28 days after treatment to determine whether there is re-infestation requiring additional treatment.
Slovenian: 28 dni po dajanju zdravila naj veterinar opravi pregled (npr. otoskopijo) in odloči ali je prišlo do ponovne infestacije, ki zahteva dodatno zdravljenje.
English: In in vitro bio-assays, fluralaner is not affected by proven field resistances against amidines (tick), organophosphates (tick), cyclodienes (tick, flea), phenylpyrazoles (tick, flea), benzophenyl ureas (tick), and pyrethroids (tick).
Slovenian: V in vitro biotestih na fluralaner ne vpliva dokazana odpornost na terenu na amidine (klop), organofosfate (klop), ciklodiene (klop, bolha), fenilpirazole (klop, bolha), benzofenil uree (klop) in piretroide (klop).
English: EU/2/18/224/001 (112.5 mg + 5.6 mg, 1 pipette) EU/2/18/224/002 (112.5 mg + 5.6 mg, 2 pipettes) EU/2/18/224/003 (250 mg + 12.5 mg, 1 pipette) EU/2/18/224/004 (250 mg + 12.5 mg, 2 pipettes) EU/2/18/224/005 (500 mg + 25 mg, 1 pipette) EU/2/18/224/006 (500 mg + 25 mg, 2 pipettes)
Slovenian: EU/2/18/224/001 (112,5 mg + 5,6 mg, 1 kapalka) EU/2/18/224/002 (112,5 mg + 5,6 mg, 2 kapalki) EU/2/18/224/003 (250 mg + 12,5 mg, 1 kapalka) EU/2/18/224/004 (250 mg + 12,5 mg, 2 kapalki) EU/2/18/224/005 (500 mg + 25 mg, 1 kapalka) EU/2/18/224/006 (500 mg + 25 mg, 2 kapalki)
English: For the treatment of infections with intestinal roundworm (4th stage larvae, immature adults and adults of Toxocara cati) and hookworm (4th stage larvae, immature adults and adults of Ancylostoma tubaeforme).
Slovenian: Za zdravljenje infekcij s črevesnimi glistami (ličinke 4. stopnje, nezrele odrasle in odrasle oblike Toxocara cati) in trakuljami (ličinke 4. stopnje, nezrele odrasle in odrasle oblike Ancylostoma tubaeforme).
English: The product is highly flammable.
Slovenian: To zdravilo je zelo vnetljivo.
English: Therefore prior to application of Bravecto Plus for the concurrent prevention of infection with adult D. immitis, the advice provided in section 12 should be considered.
Slovenian: Zato je treba pred uporabo zdravila Bravecto Plus za sočasno preventivo okužbe z odraslimi D. immitis upoštevati nasvet iz poglavja 12.
English: In case of accidental ingestion, seek medical advice and show the package leaflet or the label to the physician.
Slovenian: V primeru nenamernega zaužitja poiščite zdravniški nasvet in pokažite zdravniku navodilo za uporabo ali nalepko.
English: Cap does not come off.
Slovenian: Pokrovček se ne odstrani.
English: Bravecto Plus spot-on solution is available in three pipette sizes.
Slovenian: Zdravilo Bravecto Plus solucija za kožni nanos je na voljo v treh velikostih kapalk.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega za sproščanje serij
English: Read package leaflet for full user safety information.
Slovenian: Pri rokovanju in nanašanju zdravila uporabljajte rokavice Za popolne varnostne informacije za uporabnika preberite navodilo za uporabo.
English: The product binds to skin and may also bind to surfaces after spillage of the product.
Slovenian: Zdravilo se veže na kožo in se v primeru razlitja lahko veže na površino, kjer se je zdravilo razlilo.
English: The pharmacokinetic profiles of fluralaner and moxidectin are not affected by co-administration.
Slovenian: Na farmakokinetični profil fluralanerja in moksidektina sočasno dajanje ne vpliva.
English: MANUFACTURER'S BATCH NUMBER
Slovenian: PROIZVAJALČEVA ŠTEVILKA SERIJE Lot:{številka}
English: For the concurrent treatment of infections with ear mites (Otodectes cynotis), a single dose of the product should be applied.
Slovenian: Za sočasno zdravljenje infestacij z ušesnimi garjami (Otodectes cynotis) je potrebno dati en sam odmerek zdravila.
English: For the concurrent treatment of infections with the gastrointestinal nematodes T. cati and A. tubaeforme, a single dose of the product should be applied.
Slovenian: Za sočasno zdravljenje okužb z gastrointestinalnimi nematodi T. cati in A. tubaeforme je treba dati en sam odmerek zdravila.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo za uporabo v veterinarski medicini:
English: for small cats 1.2 - 2.8kg for medium-sized cats >2.8 - 6.25 kg for large cats >6.25 - 12.5 kg
Slovenian: za majhne mačke 1,2 - 2,8 kg za srednje velike mačke >2,8 - 6,25 kg za velike mačke >6,25 - 12,5 kg
English: Fluralaner is readily systemically absorbed from the topical administration site, reaching maximum concentrations in plasma between 3 and 21 days after administration.
Slovenian: Po topikalnem dajanju se fluralaner zlahka absorbira iz mesta nanosa in doseže maksimalno koncentracijo v krvni plazmi med 3 in 21 dnevi po dajanju.
English: Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents, endectocides, milbemycins.
Slovenian: Farmakoterapevtska skupina: antiparazitiki, insekticidi in repelenti, endektocidi, milbemicini Oznaka ATCvet: QP54AB52
English: In order to avoid contact, disposable protective gloves obtained with this product at the point of sale must be worn when handling and administering the product.
Slovenian: Da bi se izognili stiku, je pri rokovanju in dajanju zdravila treba nositi zaščitne rokavice za enkratno uporabo, ki ste jih prejeli skupaj s tem zdravilom na prodajnem mestu.
English: It is efficacious against ticks (Ixodes ricinus), fleas (Ctenocephalides felis) and ear mites (Otodectes cynotis) on the cat.
Slovenian: ), bolham (Ctenocephalides felis) in ušesnim garjam (Otodectes cynotis) pri mačkah.
English: Marketing authorisation holder: Intervet International B. V. Wim de Körverstraat 35
Slovenian: Imetnik dovoljenja za promet z zdravilom: Intervet International B. V.
English: Within each weight band, the content of one whole pipette should be used.
Slovenian: Za vsako stopnjo telesne mase je treba porabiti eno polno kapalko.
English: Do not use this veterinary medicinal product after the expiry date stated on the packaging after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na pretisnem omoti za EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
English: Moxidectin is readily systemically absorbed from the topical administration site, reaching maximum concentrations in plasma between 1 and 5 days after administration.
Slovenian: Moksidektin se po topikalnem dajanju zlahka absorbira iz mesta nanosa in doseže maksimalno koncentracijo v krvni plazmi med 1 in 5 dnevi po dajanju.
English: The following other adverse reactions were uncommonly observed in clinical trials shortly after administration: dyspnoea after licking the application site, hypersalivation, emesis, haematemesis, diarrhoea, lethargy, pyrexia, tachypnoea, mydriasis.
Slovenian: Kratek čas po dajanju zdravila so bili občasno opaženi naslednji neželeni učinki: dispneja po lizanju mesta nanosa, povečano slinjenje, emeza, hematemeza, diareja, letargija, pireksija, tahipneja, midriaza.
English: The pipette should be held by the base or by the upper rigid portion below the cap in an upright position (tip up) for opening it.
Slovenian: Merilno kapalko je treba držati za njeno bazo ali za trdi del pod zaporko v pokončnem položaju za odpiranje.
English: Skin rashes, tingling or numbness have been reported in a small number of individuals after skin contact.
Slovenian: Po stiku s kožo so pri manjšem številu posameznikov poročali o izpuščajih, mravljinčenju ali otrplosti kože.
English: Avoid contact with skin, mouth and/or eye. Do not contact the application site until it is no longer noticeable.
Slovenian: Izogibajte se stiku s kožo, usti in/ali očmi.
English: The pipettes should be kept in the sachets to prevent solvent loss or moisture uptake.
Slovenian: Merilne kapalke hranite v vrečicah, da se prepreči izgubo vehikla in da se ne navzame vlage.
English: Butylhydroxytoluene Dimethylacetamide Glycofurol
Slovenian: 6.1 Seznam pomožnih snovi butilhidroksitoluen dimetilacetamid glikofurol dietiltoluamid (DEET) aceton
English: Place the pipette tip on the base of the skull of the cat.
Slovenian: Nastavite vrh kapalke na kožo na spodnji del lobanje.
English: No adverse reactions were observed following topical administration to kittens aged 9-13 weeks and weighing 0.9-1.9 kg treated with overdoses of up to 5 times the maximum recommended dose (93 mg fluralaner + 4.65 mg moxidectin, 279 mg fluralaner + 13.95 mg moxidectin and 465 mg fluralaner + 23.25 mg moxidectin/kg body weight) on three occasions at shorter intervals than recommended (8week intervals).
Slovenian: Ko so mačkam, starim 9-13 tednov in težkim 0,9-1,9 kg, dajali topikalno do 5 krat večje odmerke od največjega priporočenega odmerka (93 mg fluralanerja + 4,65 mg moksidektina, 279 mg fluralanerja +13,95 mg moksidektina in 465 mg fluralanerja + 23,25 mg moksidektina/ kg telesne mase ) trikrat v krajših razmikih, kot je priporočeno (8-tedenski razmiki), niso opazili nobenih neželenih učinkov.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti 6.4 Posebna navodila za shranjevanje
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pipette
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: 112.5 mg fluralaner / 5.6 mg moxidectin 250 mg fluralaner / 12.5 mg moxidectin 500 mg fluralaner / 25 mg moxidectin
Slovenian: KOLIČINA UČINKOVINE 112,5 fluralaner / 5,6 mg moksidektin 250 mg fluralaner /12,5 mg moksidektin 500 mg fluralaner / 25 mg moksidektin
English: The product should be applied on cats up to 6.25 kg body weight in one spot at the base of the skull and in two spots at the base of the skull on cats greater than 6.25 kg bodyweight.
Slovenian: Zdravilo dajte mačkam, ki tehtajo do 6,25 kg na eno mesto oz. na dve mesti mačkam, ki tehtajo več kot 6,25 kg na spodnji del lobanje.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
English: Pipette content (ml) Fluralaner (mg)
Slovenian: Fluralaner (mg)
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
English: TARGET SPECIES
Slovenian: CILJNE ŽIVALSKE VRSTE Mačke.
English: Butylhydroxytoluene 1.07 mg/ml Clear colourless to yellow solution.
Slovenian: Pomožne snovi: butilhidroksitoluen 1,07 mg/ml
English: Mild and transient skin reactions at the application site (alopecia, flaking skin and pruritus) were commonly observed in clinical trials.
Slovenian: Med kliničnimi testiranji so bile pogosto opažene blage in prehodne kožne reakcije na mestu nanosa (luščenje kože, srbenje in izpadanje dlake) .
English: The twistand-use cap should be rotated clockwise or counter clockwise one full turn.
Slovenian: Zaporko zavrtite v smeri urinega kazalca ali nasprotni smeri urinega kazalca za en cel obrat.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: NAČIN IN POT(I) UPORABE Nanos na kožo.
English: Lot:{number}
Slovenian: ŠTEVILKA SERIJE Lot:{številka}
English: This product is harmful after ingestion.
Slovenian: Zdravilo je škodljivo, če se ga zaužije.
English: BATCH NUMBER
Slovenian: vrečica
English: EXPIRY DATE
Slovenian: Način dajanja
English: Butylhydroxytoluene 1.07 mg/ml For the full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Bravecto Plus 112.5 mg / 5.6 mg spot-on solution for small cats (1.2 - 2.8 kg) Bravecto Plus 250 mg / 12.5 mg spot-on solution for medium-sized cats (>2.8 - 6.25 kg) Bravecto Plus 500 mg / 25 mg spot-on solution for large cats (>6.25 - 12.5 kg)
Slovenian: Bravecto Plus 112,5 mg / 5,6 mg kožni nanos, raztopina za majhne mačke (1,2 - 2,8 kg) Bravecto Plus 250 mg/ 12,5 mg kožni nanos, raztopina za srednje velike mačke (>2,8 - 6,25 kg) Bravecto Plus 500 mg / 25 mg kožni nanos, raztopina za velike mačke (>6,25 - 12,5 kg)
English: PACKAGE LEAFLET: Bravecto Plus 112.5 mg / 5.6 mg spot-on solution for small cats (1.2 - 2.8 kg) Bravecto Plus 250 mg / 12.5 mg spot-on solution for medium-sized cats (>2.8 - 6.25 kg) Bravecto Plus 500 mg / 25 mg spot-on solution for large cats (>6.25 - 12.5 kg)
Slovenian: NAVODILO ZA UPORABO: Bravecto Plus112,5 mg / 5,6 mg kožni nanos, raztopina za majhne mačke (1,2 - 2,8 kg) Bravecto Plus 250 mg / 12,5 mg kožni nanos, raztopina za srednje velike mačke (>2,8 - 6,25 kg) Bravecto Plus 500 mg / 25 mg kožni nanos, raztopina za velike mačke (>6,25 - 12,5 kg)
English: Bravecto Plus 112.5 mg / 5.6 mg spot-on solution for small cats (1.2 - 2.8 kg) Bravecto Plus 250 mg / 12.5 mg spot-on solution for medium-sized cats (>2.8 - 6.25 kg) Bravecto Plus 500 mg / 25 mg spot-on solution for large cats (>6.25 - 12.5 kg) Fluralaner / moxidectin
Slovenian: Bravecto Plus112,5 mg / 5,6 mg kožni nanos, raztopina za majhne mačke (1,2 - 2,8 kg) Bravecto Plus 250 mg / 12,5 mg kožni nanos, raztopina za srednje velike mačke (>2,8 - 6,25 kg) Bravecto Plus 500 mg / 25 mg kožni nanos, raztopina za velike mačke (>6,25 - 12,5 kg) fluralaner / moksidektin
English: Bravecto Plus 112.5 mg + 5.6 mg spot-on solution for small cats Bravecto Plus 250 mg + 12.5 mg spot-on solution for medium-sized cats Bravecto Plus 500 mg + 25 mg spot-on solution for large cats
Slovenian: Velikost merilne kapalke, ki jo je treba dati Bravecto Plus 112,5 mg + 5,6 mg kožni nanos, raztopina za majhne mačke Bravecto Plus 250 mg + 12,5 mg kožni nanos, raztopina za srednje velike mačke
English: To be supplied only on veterinary prescription.
Slovenian: Za shranjevanje zdravila za uporabo v veterinarski medicini ni posebnih temperaturnih omejitev.
English: BRAVECTO PLUS spot-on solution
Slovenian: BRAVECTO PLUS kožni nanos, raztopina
English: • allergy
Slovenian: • alergij
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu lahko ustrezni organi države članice naknadno posodobijo, v sodelovanju z referenčno državo članico, kot je primerno, v skladu s postopki, opisanimi v poglavju 4, naslovu III Direktive 2001/83/ES.
English: Patients should be advised to promptly report any cardiac symptoms.
Slovenian: Bolnikom je treba svetovati, naj o vseh srčnih simptomih takoj poročajo.
English: Treatment with hydroxyzine should be stopped.
Slovenian: Zdravljenje s hidroksizinom je treba ustaviti.
English: Do not take X if you are taking medicine to treat:
Slovenian: Ne jemljite zdravila X, če jemljete zdravila za zdravljenje:
English: Therefore, the combination is contra-indicated (see section 4.3).
Slovenian: Zato so te kombinacije kontraindicirane (glejte poglavje 4.3).
English: Section 4 “Possible side effects”
Slovenian: Poglavje 4 "Možni neželeni učinki"
English: In the event of overdose, symptomatic treatment could be implemented.
Slovenian: V primeru prevelikega odmerjanja je treba uvesti simptomatsko zdravljenje.
English: If you have used or taken too much X, immediately contact [to be completed nationaly], in particular if a child has taken too much.
Slovenian: Če ste uporabili ali vzeli preveč zdravila X, se takoj obrnite na [izpolni država članica], zlasti, če je preveč zdravila vzel otrok.
English: Therefore, tell your doctor if you have any heart problems or are taking any other medicines, including medicines obtained without prescription.
Slovenian: Zato morate zdravniku povedati, če imate kakršne koli težave s srcem ali če jemljete druga zdravila, vključno z zdravili, ki ste jih dobili brez recepta.
English: Treatment with hydroxyzine should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should seek immediate medical attention.
Slovenian: Zdravljenje s hidroksizinom je treba ustaviti, če se pojavijo znaki ali simptomi, ki so morda povezani s srčno aritmijo, bolniki pa morajo takoj poiskati zdravniško pomoč.
English: <Tell your <doctor> <or> <pharmacist> if you are <taking> <using>, have recently <taken> <used> or might <take> <use> any other medicines.> This includes any medicines obtained without prescription.
Slovenian: <Obvestite <zdravnika><ali><farmacevta>, če <jemljete><uporabljate>, ste pred kratkim <jemali><uporabljali> ali pa boste morda začeli <jemati><uporabljati> katero koli drugo zdravilo.> To vključuje zdravila, ki ste jih dobili brez recepta.
English: X may be associated with an increased risk of heart rhythm disorder which may be life threatening.
Slovenian: Zdravilo X je lahko povezano z večjim tveganjem za motnje srčnega ritma, ki so lahko življenjsko nevarne.
English: X can affect or be affected by other medicinal products.
Slovenian: Druga zdravila lahko vplivajo na zdravilo X ali pa le-to vpliva na druga zdravila.
English: Not known (frequency cannot be estimated from the available data) Stop taking the medicine and seek immediate medical attention if you experience any problems with the heart rhythm such as palpitations, trouble breathing or loss of consciousness.
Slovenian: Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) Takoj prenehajte jemati zdravilo in poiščite zdravniško pomoč, če se pojavijo kakršne koli težave s srčnim ritmom, kot so palpitacije, težave z dihanjem ali izguba zavesti.
English: While taking X, seek immediate medical attention if you experience heart problems such as palpitations, trouble breathing, loss of consciousness.
Slovenian: Med jemanjem zdravila X, poiščite takojšnjo zdravniško pomoč, če se pojavijo težave s srcem, kot so palpitacije, težave z dihanjem, izguba zavesti.
English: Patients with a known acquired or congenital QT interval prolongation.
Slovenian: Bolniki z znanim pridobljenim ali prirojenim podaljšanjem intervala QT.
English: Most of these patients had other risk factors, electrolyte abnormalities and concomitant treatment that may have been contributory (see section 4.8).
Slovenian: Večina teh bolnikov je imela druge dejavnike tveganja, nenormalne ravni elektrolitov in sočasna zdravljenja, ki so lahko k temu prispevala (glejte poglavje 4.8).
English: Section 2 “What you need to know before you <take> <use> X”
Slovenian: Poglavje 2 "Kaj morate vedeti, preden <boste vzeli><boste uporabili> zdravilo X"
English: Hydroxyzine has been associated with prolongation of the QT interval on the electrocardiogram.
Slovenian: Hidroksizin povezujejo s podaljšanjem intervala QT na elektrokardiogramu.
English: In the elderly, the maximum daily dose is 50 mg per day (see section 4.4).
Slovenian: Pri starejših je največji dnevni odmerek 50 mg na dan (glejte poglavje 4.4).
English: Hydroxyzine is not recommended in elderly patients because of a decrease of hydroxyzine elimination in this population as compared to adults and the greater risk of adverse reactions (e.g. anticholinergic effects) (see sections 4.2 and 4.8).
Slovenian: Hidroksizin se ne priporoča pri starejših bolnikih, saj je pri tej populaciji v primerjavi z odraslimi izločanje hidroksizina zmanjšano, tveganje neželenih učinkov pa večje (npr. antiholinergični učinki) (glejte poglavji 4.2 in 4.8).
English: • drug abuse or severe pain (methadone)
Slovenian: • zlorabe drog ali hude bolečine (metadon)
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Slovenian: Popravki zadevnih poglavij povzetka glavnih značilnosti zdravila in navodilo za uporabo so rezultat postopka napotitve.
English: The following wording should be present in this section:
Slovenian: To poglavje mora vsebovati naslednje besedilo:
English: The following wording should be included in the specified sections:
Slovenian: Spodnje besedilo je treba vključiti v ustrezna poglavja:
English: • depression (e.g. citalopram, escitalopram)
Slovenian: • depresije (npr. citalopram, escitalopram)