FrancophonIA/ELRC3.0 huggingface dataset:
English: While acknowledging the absence of commingling of the animals which is a worst-case-scenario according to the CVMP guideline on specific efficacy requirements for ectoparasiticides in cattle (EMEA/CVMP/625/03)1, as a limitation in the study, the CVMP considered the study well conducted.
Slovenian: Čeprav je priznan omejitev pri študiji, ker se živali niso mešale, kar je v skladu s smernico odbora za zdravila za uporabo v veterinarski medicini (CVMP) o posebni učinkovitosti zahtev za zatiranje zunanjih zajedavcev pri govedu najslabši mogoči scenarij (EMEA/CVMP/625/03)1, pa je odbor CVMP menil, da je bila študija dobro izvedena.
English: The comparable efficacy of the moxidectin/triclabendazole pour-on combination product (Cydectin TriclaMox) compared to moxidectin alone in the same vehicle was studied in a pharmacokinetics trial.
Slovenian: Primerljiva učinkovitost kombiniranega zdravila moksidektina/triklabendazola (Cydectin TriclaMox), ki se uporablja kot kožno poliv, v primerjavi z moksidektimom samim v isti nosilni raztopini se je preučila s farmakokinetičnim preskusom.
English: • the CVMP reviewed all available data submitted by the marketing authorisation holder, to support the indication for treatment of lice infestations caused by Linognatus vituli, Bovicola bovis and Solenopotes capillatus;
Slovenian: • pregledal vse razpoložljive podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom v podporo indikaciji za zdravljenje napadov uši, ki jih povzročijo vrste Linognatus vituli, Bovicola bovis in Solenopotes capillatus;
English: Grounds for the variation to the terms of the marketing authorisations
Slovenian: Razlogi za spremembo pogojev za dovoljenja za promet z zdravili
English: Pfizer Animal Health submitted an application for a type II variation to add a new indication against lice species (Linognatus vituli, Bovicola bovis and Solenopotes capillatus) and reference was made to the monoproduct, Cydectin pour-on containing moxidectin alone and for which the claim against lice was already granted.
Slovenian: Proizvajalec Pfizer Animal Health je predložil vlogo za spremembo tipa II, da bi dodal novo indikacijo proti vrstam uši (Linognatus vituli, Bovicola bovis in Solenopotes capillatus), skliceval pa se je le na eno učinkovino zdravila, kožni poliv Cydectin, ki vsebuje le moksidektin in za katerega je bila zahteva za delovanje proti ušem že odobrena.
English: • the CVMP on the basis of the available data considered that a satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus can be expected in the field;
Slovenian: • na podlagi razpoložljivih podatkov menil, da je v praksi mogoče pričakovati zadovoljivo učinkovitost v zvezi z vrstami Linognatus vituli, Bovicola bovis in Solenopotes capillatus;
English: The CVMP based the extrapolation of the efficacy of the product on Linognatus vituli to the two other lice species proposed (Bovicola bovis and Solenopotes capillatus) on the results of a dose determination study with the monoproduct containing moxidectin as active substance where the three proposed claimed lice species were shown to be controlled (>95 % except for Solenopotes capillatus adult before day 21) at half dose for the monoproduct (0.25 mg/kg bw instead of 0.5 mg/kg bw), supported by the pharmacokinetics finding giving no strong signal of interaction between the two active substances in Cydectin TriclaMox.
Slovenian: Odbor CVMP je ekstrapolacijo učinkovitosti proizvoda na vrsto Linognatus vituli oprl na dve drugi predlagani vrsti uši (Bovicola bovis in Solenopotes capillatus) na podlagi rezultatov raziskave o določanju odmerka v zdravilu s samo eno učinkovino, ki kot aktivno snov vsebuje moksidektin, pri kateri je bilo dokazano, da so tri predlagane zahtevane vrste uši pod nadzorom (več kot 95 %, razen za odrasle primerke vrste Solenopotes capillatuspred 21. dnevom) pri polovičnem odmerku v zdravilu s samo eno učinkovino (0,25 mg/kg telesne mase namesto 0,5 mg/kg telesne mase), podprto s farmakokinetično ugotovitvijo, ki ni kazala bistvenih znakov navzkrižnega delovanja med aktivnima snovema v proizvodu Cydectin TriclaMox.
English: In order to address the concerns raised by Belgium the MAH provided data to support the noninterference between triclabendazole and moxidectin, a clinical study regarding the efficacy against Linognatus vituli and Bovicola bovis and literature on the efficacy of moxidectin against lice species.
Slovenian: Da bi imetnik dovoljenja za promet z zdravilom odpravil pomisleke Belgije, je predložil podatke v podporo trditvi, da ni navzkrižnega delovanja med triklabendazolom in moksidektinom, klinično študijo o učinkovitosti proti vrstama Linognatus vituli in Bovicola bovis ter literaturo o učinkovitosti moksidektina proti vrstam uši.
English: Treatment of mixed trematode (fluke) and nematode infections and certain arthropod infestations caused by moxidectin and triclabendazole sensitive strains of:
Slovenian: Zdravljenje mešanih infestacij s trematodi (metljaj) in nematodi ter določenimi vrstami artropodov, z vrstami, ki so občutljive na kombinacijo moksidektina in triklabendazola:
English: Parasite
Slovenian: Paraziti
English: The benefit-risk evaluation is deemed to be positive for granting of the variation to the terms of the marketing authorisations for Cydectin TriclaMox concerning treatment of Linognatus vituli, Bovicola bovis and Solenopotes capillatus infestations caused by moxidectin sensitive strains.
Slovenian: Šteje se, da je ocena razmerja med koristjo in tveganjem za odobritev spremembe pogojev dovoljenj za promet z zdravilom Cydectin ZtriclaMox v zvezi z zdravljenjem napadov uši vrst Linognatus vituli, Bovicola bovis in Solenopotes capillatus, ki jih povzročijo za moksidektin občutljivi sevi uši, ugodna.
English: Based on (i) the comparable pharmacokinetic profiles for moxidectin when administered as the combination product compared with moxidectin alone in the same vehicle, (ii) the findings of the confirmatory study with Linognatus vituli and (iii) the data from the original moxidectin 0.5% pour-on dossier showing that Linognatus vituli, Bovicola bovis and Solenopotes capillatus were sensitive to moxidectin at half the recommended dose rate (0.25 mg/kg), the CVMP considered that a satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus can be expected in the field for Cydectin TriclaMox.
Slovenian: Odbor CVMP je na podlagi (i) primerljivih farmakokinetičnih profilov za moksidektin, če se daje kot kombinirano zdravilo, v primerjavi z moksidektinom kot edino učinkovino v nosilni raztopini, (ii) ugotovitev potrditvene študije z vrsto Linognatus vituli in (iii) podatkov iz prvotne dokumentacije o 0,5-odstotnem kožnem polivu moksidektina, ki kažejo, da so vrste Linognatus vituli, Bovicola bovis in Solenopotes capillatus občutljive za polovični priporočeni odmerek moksidektina (0,25 mg/kg), menil, da je mogoče za zdravilo Cydectin TriclaMox v praksi pričakovati zadovoljivo učinkovitost v zvezi z vrstami Linognatus vituli, Bovicola bovis in Solenopotes capillatus.
English: A confirmatory trial was provided where the efficacy of moxidectin/triclabendazole pour-on combination in cattle was studied at the recommended dose rate of Cydectin TriclaMox (0.5 mg moxidectin/20 mg triclabendazole/kg body weight) against natural infestations of sucking and/or biting lice, with emphasis primarily on Linognatus vituli and secondarily on Bovicola bovis by comparison with a placebo-treated control group.
Slovenian: Kjer se je učinkovitost kombinacije moksidektina/triklabendazola v kožnem polivu za govedo iz moksidektina/triklabendazola preučevala v priporočenem odmerku zdravila Cydectin TriclaMox (0,5 mg moksidektina/20 mg triklabendazola/kg telesne mase) kot sredstvo proti naravnim napadom uši, ki pikajo ali grizejo, s poudarkom zlasti na vrsti Linognatus vituli in podredno na vrsti Bovicola bovis, s primerjavo s kontrolno skupino, ki je prejemala placebo, je bil opravljen potrditveni preskus.
English: Cydectin TriclaMox pour-on solution is a veterinary medicinal product containing 5 mg moxidectin per ml and 200 mg triclabendazole per ml.
Slovenian: Cydectin TriclaMox je raztopina za kožni poliv za uporabo v veterinarski medicini, ki vsebuje 5 mg moksidektina na ml in 200 mg triklabendazola na ml.
English: The CVMP concluded that a second dose confirmatory study for Linognatus vituli or the other lice species was deemed not to be necessary based on the data from the confirmatory study and moxidectin's efficacy demonstrated on all other lice species as well as in the literature, even if Linognatus vituli is not considered as being the dose-limiting species.
Slovenian: Ta odbor je sklenil, da se na podlagi podatkov iz potrditvene študije in učinkovitosti moksidektina, dokazane na vseh drugih vrstah uši in tudi v literaturi, potrditvena študija z drugim odmerkom za vrsto Linognatus vituli ali druge vrste uši ni štela za potrebno, čeprav se Linognatus vituli ne šteje kot vrsta, ki potrebuje največji odmerek, če naj bi bil ta učinkovit.
English: Overall summary of the scientific evaluation of Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle (see Annex I)
Slovenian: Splošni povzetek znanstvene ocene zdravila Cydectin TriclaMox (5 mg/ml in 200 mg/ml), raztopine za kožni poliv za govedo (glej Prilogo I)
English: Cydectin TriclaMox
Slovenian: Cydectin TriclaMox Moxidectin Triclabendazo le
English: Laboratórios Pfizer, Lda Lagoas Park - Edíficio 10 2740-271 Porto Salvo Portugal
Slovenian: Portugalska Laboratórios Pfizer, Lda Lagoas Park - Edíficio 10
English: Belgium Pfizer Animal Health s.a. Rue Laid Burniat 1
Slovenian: Pfizer Animal Health s.a. Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgija
English: Adjuvant MF59C.1 containing squalene (9.75 milligrams), polysorbate 80 (1.175 milligrams), sorbitan trioleate (1.175 milligrams)
Slovenian: Adjuvans MF59C.1 vsebuje skvalen (9,75 miligramov), polisorbat 80 (1,175 miligramov), sorbitantrioleat (1,175 miligramov)
English: Packagin
Slovenian: Ovojnina
English: Strength Pharmaceutica l Form
Slovenian: Farmacevtska oblika Pot uporabe
English: 7.5 micrograms** per 0.5 ml dose
Slovenian: 5,0 ml (1 odmerek = 0,5 ml)
English: Content (concentration)
Slovenian: Viala (steklo)
English: 1 Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/7/2009 (H1N1)v like strain used (X-179A)
Slovenian: X-179A (podoben sevu A/California/7/2009 (H1N1)v) 7,5 mikrogramov** na odmerek 0,5 ml * razmnožen v jajcih ** izraženo v mikrogramih hemaglutinina
English: 10 multidose vials
Slovenian: 10 napolnjenih injekcijskih brizg
English: * propagated in eggs ** expressed in microgram haemagglutinin.
Slovenian: 1 Površinski antigeni (hemaglutinin in nevraminidaza) seva virusa influence*:
English: 3 syringes in a carton box
Slovenian: 3 brizge v zloženki
English: 1 syringe in a carton box
Slovenian: 1 brizga v zloženki
English: San Sebastian de los Reyes, Spain
Slovenian: San Sebastian de los Reyes, Španija
English: {Name and address} {tel} {fax} {e-mail}
Slovenian: {Ime in naslov} {tel.} {faks} {e-mail}
English: Frequency cannot be estimated from the available data
Slovenian: Pogostnosti iz razpoložljivih podatkov ni mogoče oceniti.
English: 2130 AG HOOFDDORP The Netherlands
Slovenian: 2130 AG HOOFDDORP Nizozemska
English: Belgium, Luxembourg
Slovenian: Belgija, Luksemburg
English: *[Please note that not all listed products and strengths may be available.]
Slovenian: *[Vsa navedena pakiranja in jakosti morda niso na voljo.]
English: Ireland, Malta, United Kingdom
Slovenian: Irska, Malta, Velika Britanija
English: It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
Slovenian: Izjemno pomembno je, da svojega zdravnika ali farmacevta obvestite, če jemljete katerokoli zdravilo, ki vsebuje:
English: 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens Greece
Slovenian: 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Atene Grčija
English: If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then increase the dose gradually.
Slovenian: Če se zdravite zaradi panične motnje, bo zdravnik začel z nižjim odmerkom (37,5 mg) in bo nato odmerek zviševal postopoma.
English: Take Efexor depot at approximately the same time each day, either in the morning or in the evening.
Slovenian: Zdravilo Efexor depot morate jemati vsak dan ob približno istem času, lahko zjutraj ali zvečer.
English: Do not drive or use any tools or machines until you know how Efexor depot affects you.
Slovenian: Ne vozite in ne uporabljajte orodja ali strojev, dokler ne ugotovite, kako zdravilo Efexor depot vpliva na vas.
English: Use in children and adolescents under the age of 18 years: it was agreed that “Venlafaxine is not recommended for use in children and adolescents”.
Slovenian: Uporaba pri otrocih in mladostnikih, mlajših od 18 let: sprejeto je bilo, da „se Venlafaksin ne priporoča za uporabo pri otrocih in mladostnikih“.
English: If it is not treated, your condition may not go away and may become more serious and more difficult to treat.
Slovenian: Če se jih ne zdravi, se vaše stanje morda ne bo izboljšalo, ampak bo postalo bolj resno in težje ozdravljivo.
English: You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Slovenian: Prosite ga lahko tudi, da naj vas opozori, če meni, da se je vaša depresija ali anksioznost poslabšala in ali ga skrbijo spremembe v vašem vedenju.
English: This group of medicines is used to treat depression and other conditions such as anxiety disorders.
Slovenian: Ta skupina zdravil se uporablja za zdravljenje depresije in drugih bolezni, kot so na primer anksiozne motnje.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF EFEXOR DEPOT AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA EFEXOR DEPOT IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: Treatment of panic disorder, with or without agoraphobia.
Slovenian: Zdravljenje panične motnje, z agorafobijo ali brez nje.
English: Cyprus, Greece, Estonia, Lithuania, Portugal Efexor XR
Slovenian: Ciper, Grčija, Estonija, Litva, Portugalska Efexor XR
English: • If you are allergic to venlafaxine or any of the other ingredients of Efexor depot.
Slovenian: • če ste alergični na venlafaksin ali katerokoli sestavino zdravila Efexor depot.
English: Denmark, Finland, Iceland, Norway, Sweden Efexor Depot France
Slovenian: Danska, Finska, Islandija, Norveška, Švedska Efexor Depot Francija
English: Czech Republic, Romania
Slovenian: Češka republika, Romunija
English: • If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease.
Slovenian: • če jemljete ali ste kadarkoli v zadnjih 14 dneh jemali katerakoli zdravila, ki so znana kot ireverzibilni zaviralci monoaminooksidaze (zaviralci MAO), ki se uporabljajo za zdravljenje depresije ali Parkinsonove bolezni.
English: Germany Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster
Slovenian: Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster Nemčija
English: Treating depression or anxiety disorders properly is important to help you get better.
Slovenian: Ustrezno zdravljenje depresije in anksioznih motenj je pomembno, ker pripomore k vašemu okrevanju.
English: The initial dose in panic disorder studies was 37.5 mg/day for 7 days.
Slovenian: Začetni odmerek v raziskavah panične motnje je bil 37,5 mg/dan 7 dni.
English: A minority of CHMP members were of the opinion that this indication should be deleted from section 4.1, and a statement should be included in section 4.2, to indicate that longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes.
Slovenian: Manjšina članov Odbora za zdravila za uporabo v humani medicini (CHMP) je menila, da je to indikacijo treba izbrisati iz poglavja 4.1 ter da je v poglavje 4.2 treba vključiti izjavo, da je za preprečevanje ponovnega pojavljanja hudih depresivnih epizod lahko ustrezno tudi dolgoročno zdravljenje;
English: Taking Efexor depot with food and drink
Slovenian: Jemanje zdravila Efexor depot skupaj s hrano in pijačo
English: Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Efexor depot for a long time.
Slovenian: Zato vas bo zdravnik občasno napotil na preiskave krvi, še posebej če jemljete zdravilo Efexor depot že dolgo časa.
English: Box 255
Slovenian: P.O. Box 255
English: With regards to cardiovascular safety, it was agreed that a contraindication was not warranted and that a revised wording for Section 4.4 was sufficient.
Slovenian: Glede varnosti srca in ožilja je bilo dogovorjeno, da kontraindikacija ni potrebna ter da revidirano besedilo poglavja 4.4 zadostuje.
English: If your doctor thinks that you no longer need Efexor depot, he/she may ask you to reduce your dose slowly before stopping treatment altogether.
Slovenian: Če vaš zdravnik misli, da zdravila Efexor depot ne potrebujete več, vam bo počasi zniževal odmerek, preden vam bo zdravljenje popolnoma ukinil.
English: 171 42 Solna, Sweden
Slovenian: 171 42 Solna, Švedska
English: The Netherlands Wyeth Pharmaceuticals B.V. P.O.
Slovenian: Nizozemska Wyeth Pharmaceuticals B.V.
English: Efexor depot is a treatment for adults with depression.
Slovenian: Zdravilo Efexor depot se uporablja za zdravljenje odraslih bolnikov z depresijo.
English: If any of these conditions apply to you, please talk with your doctor before taking Efexor depot.
Slovenian: Če se katera od teh stanj nanašajo za vas, se pogovorite s svojim zdravnikom, preden začnete jemati zdravilo Efexor depot.
English: It was agreed that “No specific dose adjustments are considered necessary based on patient age alone”.
Slovenian: Sprejeto je bilo, da „Samo na podlagi starosti bolnika prilagoditve odmerkov niso potrebne“.
English: Major Depressive Episodes: the CHMP considered that the maximum dose of 375mg/day Efexor depot is safe and effective in a long term perspective and recommended that it is approved without duration limitations in the harmonized SPC.
Slovenian: Hude depresivne episode: CHMP je menil, da je najvišji odmerek 375 mg/dan zdravila Efexor depot dolgoročno varen in učinkovit, ter je v usklajenem povzetku glavnih značilnosti zdravila priporočil odobritev brez časovnih omejitev.
English: Patients continued to receive the same dose of venlafaxine prolonged-release that they had taken at the end of the open-label phase (75, 150, or 225 mg).
Slovenian: Bolniki so še naprej prejemali enak odmerek venlafaksina s podaljšanim sproščanjem, kot so ga prejemali na koncu odprte faze (75, 150 ali 225 mg).
English: Venlafaxine and ODV are minimally bound at therapeutic concentrations to human plasma proteins (27% and 30%, respectively).
Slovenian: Venlafaksin in ODV se v terapevtskih koncentracijah minimalno vežeta na človeške plazemske beljakovine (27 % oziroma 30 %).
English: • If you use other medicines that taken concomitantly with Efexor depot could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”).
Slovenian: • če jemljete druga zdravila, ki bi lahko pri sočasni uporabi z zdravilom Efexor depot povečala tveganje za nastanek serotoninskega sindroma (glejte poglavje “Jemanje drugih zdravil”);
English: - “treatment of social anxiety disorder” (former social phobia), given that the studies presented adequately supported the clinical efficacy of Efexor depot in this indication;
Slovenian: - „zdravljenje socialne anksiozne motnje“ (prej socialna fobija), glede na to, da so predložene študije ustrezno potrdile klinično učinkovitost zdravila Efexor depot pri tej indikaciji;
English: Dosage increases can be made at intervals of 2 weeks or more.
Slovenian: Odmerjanje se lahko zvišuje v 2-tedenskih ali daljših presledkih.
English: If you are taking Efexor depot during pregnancy, let your midwife and/or doctor know, as your baby might have some symptoms when it is born.
Slovenian: Če jemljete zdravilo Efexor depot med nosečnostjo, o tem obvestite babico in/ali zdravnika, ker se lahko tudi pri vašem otroku po rojstvu pojavijo odtegnitveni simptomi.
English: More rarely, Efexor depot may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding.
Slovenian: Redkeje lahko zdravilo Efexor depot zmanjša delovanje krvnih ploščic v vaši krvi, kar lahko poveča tveganje za nastanek modric ali krvavitev.
English: Efexor depot is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks).
Slovenian: Zdravilo Efexor depot se uporablja tudi za zdravljenje odraslih bolnikov z naslednjimi anksioznimi motnjami: generalizirana anksiozna motnja, socialna anksiozna motnja (strah ali izogibanje družabnim situacijam) in panična motnja (napadi panike).
English: While there was also evidence for superiority over placebo for the 37.5 mg/day dose, this dose was not as consistently effective as the higher doses.
Slovenian: Čeprav je bil tudi odmerek 37,5 mg/dan učinkovitejši od placeba, pa ta odmerek ni bil tako učinkovit kot višji odmerki.
English: Like all medicines, Efexor depot can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Efexor depot neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Taking an irreversible MAOI together with other medicines, including Efexor depot, can cause serious or even life-threatening side effects.
Slovenian: Uporaba ireverzibilnega zaviralca MAO skupaj z drugimi zdravili, vključno z zdravilom Efexor depot, lahko povzroči resne ali celo življenjsko nevarne neželene učinke.
English: WHAT EFEXOR DEPOT IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO EFEXOR DEPOT IN ZA KAJ GA UPORABLJAMO
English: If your doctor has prescribed Efexor depot for a patient under 18, and you want to discuss this, please go back to your doctor.
Slovenian: Če je zdravnik zdravilo Efexor depot predpisal bolniku, mlajšemu od 18 let, in želite o tem več informacij, se posvetujte s svojim zdravnikom.
English: No specific antidotes for venlafaxine are known.
Slovenian: Specifični antidoti za venlafaksin niso znani.
English: The dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375 mg daily for depression.
Slovenian: Po potrebi lahko zdravnik odmerek postopoma zvišuje, tudi do največjega odmerka 375 mg na dan pri zdravljenju depresije.
English: The maximum dose for generalised anxiety disorder, social anxiety disorder and panic disorder is 225 mg/day.
Slovenian: Največji odmerek pri generalizirani anksiozni motnji, socialni anksiozni motnji in panični motnji je 225 mg/dan.
English: If you have liver or kidney problems, talk to your doctor, since your dose of Efexor depot may need to be different.
Slovenian: Če imate težave z jetri ali ledvicami, se pogovorite z zdravnikom, ker bo morda treba vaš odmerek zdravila Efexor depot prilagoditi.
English: Do not use Efexor depot after the expiry date, which is stated on the packaging.
Slovenian: Zdravila Efexor depot ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Use in elderly patients: based on published data raising the possibility of renal impairment and the potential for changes in neurotransmitter sensitivity and affinity with aging, a new wording for use in elderly patients was agreed in the SPC.
Slovenian: Uporaba pri starejših bolnikih: na podlagi objavljenih podatkov, na podlagi katerih se s staranjem poveča možnost za okvare ledvic ter za spremembe občutljivosti in afinitete živčnih prenašalcev, je bilo v povzetku glavnih značilnosti zdravila sprejeto novo besedilo za uporabo pri starejših bolnikih.