natgillin/translations-raw huggingface dataset:
Any psychoactive medicinal product may impair judgment, thinking, and motor skills.
Vsako psihoaktivno zdravilo lahko vpliva na presojo, mišljenje in motorične spretnosti.
This may increase the risk of caries, and patients should be advised upon the importance of dental hygiene.
To lahko poveča nevarnost kariesa, zato je treba bolnike opozoriti na pomen higiene zob.
Antidepressive medicinal products should continue for at least six months following remission.
Zdravljenje z antidepresivnimi zdravili je treba nadaljevati še vsaj šest mesecev po remisiji.
There were also increased reports of hostility and, especially in major depressive disorder, self-harm.
Pogosteje so poročali tudi o sovražnosti in, še posebej pri hudi depresiji, o samopoškodovanju.
Caution is advised, and a dose reduction by more than 50% should be considered.
Priporočljiva je previdnost in treba je razmisliti o zmanjšanju odmerka za več kot 50 %.
Taking Efexor with food and drink
Jemanje zdravila Efexor skupaj s hrano in pijačo
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”.
Uporaba pri otrocih in mladostnikih, mlajših od 18 let: sprejeto je bilo, da „se venlafaksin ne priporoča za uporabo pri otrocih in mladostnikih“.
It is unknown whether a pharmacokinetic and/or pharmacodynamic interaction with other benzodiazepines exists.
Ni znano, ali obstaja farmakokinetična in/ali farmakodinamična interakcija z drugimi benzodiazepini.
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.
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.
The following Sections of the Product Information were addressed during this harmonisation procedure.
V postopku uskladitve so bila obravnavana naslednja poglavja informacij o zdravilu.
They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
Navadno se pojavijo v prvih nekaj dneh po prekinitvi zdravljenja, zelo redko so poročali o takih simptomih pri bolnikih, ki so odmerek izpustili nenamerno.
In the majority of cases, these complications are observed immediately or within 24 hours after partus.
Pri večini primerov so te zaplete opazili takoj ali v 24 urah po porodu.
When there is a risk of aspiration, induction of emesis is not recommended.
Če obstaja tveganje za aspiracijo, sprožitev bruhanja ni priporočljiva.
This group of medicines is used to treat depression and other conditions, such as anxiety disorders.
Ta skupina zdravil se uporablja za zdravljenje depresije in drugih bolezni, kot so na primer anksiozne motnje.
If it is not treated, your condition may not go away and may become more serious and more difficult to treat.
Če se ne zdravi, se vaše stanje morda ne bo izboljšalo, ampak bo postalo bolj resno in težje ozdravljivo.
However, if it is time for your next dose, skip the missed dose and take only a single dose as usual.
Če je že čas za naslednji odmerek, pozabljenega izpustite in vzemite kot ponavadi samo en odmerek.
WHAT EFEXOR IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO EFEXOR IN ZA KAJ GA UPORABLJAMO
It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
Izjemno pomembno je, da svojega zdravnika ali farmacevta obvestite, če jemljete kakterokoli zdravilo, ki vsebuje:
Pharmacotherapeutic group: Other antidepressants - ATC code: NO6A X16.
Farmakoterapevtska skupina: Drugi antidepresivi, Oznaka ATC: NO6A X16.
This risk persists until significant remission occurs.
Takšno tveganje obstaja vse dokler ne pride do znatnega izboljšanja zdravstvenega stanja.
If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself.
Če ste depresivni in/ali imate anksiozno motnjo, se pri vas občasno lahko pojavijo misli na samopoškodovanje ali samomor.
This has most frequently been reported in volume-depleted or dehydrated patients.
O tem so najpogosteje poročali pri hipovolemičnih ali dehidriranih bolnikih.
Reduced fertility was observed in a study in which both male and female rats were exposed to ODV.
Zmanjšanje plodnosti so ugotovili v raziskavi, v kateri so bili podganji samci in samice izpostavljeni ODV.
Abnormal bleeding
Nenormalne krvavitve
Such complications can arise immediately upon delivery.
Tovrstni zapleti se lahko pojavijo neposredno po porodu.
Take Efexor at approximately the same time each day, in the morning and in the evening.
Zdravilo Efexor morate jemati vsak dan ob približno istem času, zjutraj in zvečer.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Ker se prvih nekaj tednov zdravljenja ali dlje zdravstveno stanje morda še ne bo izboljšalo, je treba bolnike skrbno nadzirati vse dokler ne pride do izboljšanja.
Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster Germany
Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster Nemčija
Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Efexor for a long time.
Zato vas bo zdravnik občasno napotil na preiskave krvi, še posebej če jemljete zdravilo Efexor že dolgo časa.
Venlafaxine must only be administered to pregnant women if the expected benefits outweigh any possible risk.
Venlafaksin se sme med nosečnostjo uporabljati le, če pričakovana korist odtehta kakršnokoli možno tveganje.
Suicide/suicidal thoughts or clinical worsening
Samomor/samomorilne misli ali klinično poslabšanje
Very common: dry mouth; headache
Zelo pogosti: suha usta; glavobol
In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during the current episode.
Pri večini bolnikov je priporočeni odmerek za preprečevanje ponovitev MDE enak tistemu, ki se uporablja za zdravljenje že prisotne epizode.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF EFEXOR AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA EFEXOR IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
• If you have previously had thoughts about killing yourself or harming yourself.
• če ste že kdaj razmišljali o samomoru ali o samopoškodovanju;
There are no adequate data from the use of venlafaxine in pregnant women.
Ni zadostnih podatkov o uporabi venlafaksina pri nosečnicah.
• If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• če imate težave z očmi, na primer določene vrste glavkoma (zvišan tlak v očesu);
Cardiac disease and risk of arrhythmia
Bolezni srca in tveganje za pojav aritmije
• If you are allergic to venlafaxine or any of the other ingredients of Efexor.
• če ste alergični na venlafaksin ali katerokoli sestavino zdravila Efexor.
• Heart problems, such as fast or irregular heart rate, increased blood pressure
• težave s srcem, kot sta hiter ali nepravilen srčni utrip, zvišan krvni tlak;
- the Summaries of Products Characteristic, labelling, package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
- da so bili povzetki glavnih značilnosti zdravila, označevanje, navodila za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, ovrednoteni na podlagi predložene dokumentacije in strokovne razprave v Odboru,
The lowest effective dose should always be used, and patients should be carefully monitored when an increase in the dose is required.
Vedno je treba uporabiti najmanjši še učinkovit odmerek in bolnike skrbno spremljati, kadar je treba odmerek zvišati.
QUALITATIVE AND QUANTITATIVE COMPOSITION [To be completed nationally]
KAKOVOSTNA IN KOLIČINSKA SESTAVA [Izpolni država članica.]
• If you have a history of heart problems.
• če ste kdaj imeli težave s srcem;
Important information about some of the ingredients of Efexor
Pomembne informacije o nekaterih sestavinah zdravila Efexor
• 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.
• če jemljete ali ste kadarkoli v zadnjih 14 dneh jemali katerakoli zdravila, ki so znana kot ireverzibilni zaviralci monoaminooksidaze (zaviralci MAOI), ki se uporabljajo za zdravljenje depresije ali Parkinsonove bolezni.
This has been reported under initiation, dose changes and discontinuation of treatment.
O njej so poročali pri uvedbi zdravljenja, spremembah odmerka in prekinitvi zdravljenja.
• Reproductive and sexual disorders
• Motnje reprodukcije in spolnosti
Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE).
Dolgoročnejše zdravljenje je lahko primerno tudi za preprečevanje ponovitev hudih depresivnih epizod (MDE, major depressive episodes).
Sweating (includin g night sweats)
Koža znojenje (vključno z napadi nočnega znojenja)
Dosage increases can be made at intervals of 2 weeks or more.
Odmerek se lahko zvišuje v 2-tedenskih ali daljših presledkih.
Treatment should be reassessed regularly on a case-by-case basis.
Zdravljenje je treba redno ponovno oceniti pri vsakem bolniku posebej.
In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Pri otrocih in mladostnikih tudi ni dolgoročnih podatkov o varnosti, ki zadevajo rast, dozorevanje ter kognitivni in vedenjski razvoj.
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.
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.
• If you have a history of high blood pressure.
• če ste kdaj imeli visok krvni tlak;
Patients not responding to the initial 75 mg/day dose may benefit from dose increases up to a maximum dose of 375 mg/day.
Bolnikom, ki se ne odzovejo na začetni odmerek 75 mg/dan, lahko koristi zvišanje odmerka do največjega odmerka 375 mg/dan.
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• če ste kdaj imeli, če kdo v vaši družini ima ali je imel manijo ali bipolarno motnjo (občutek prekomernega razburjenja ali pretirano dobrega počutja);
You may be more likely to think like this:
Pojav takšnih misli je verjetnejši:
However, as with all CNS-active substances, patients should be advised to avoid alcohol consumption.
Vendar je treba, tako kot pri vseh učinkovinah, ki delujejo na OŽ, bolnikom svetovati, naj se izogibajo uživanju alkoholnih pijač.
Pharmacological activity at these receptors may be related to various side effects seen with other antidepressant medicinal products, such as anticholinergic, sedative and cardiovascular side effects.
Farmakološko delovanje na teh receptorjih je lahko povezano z različnimi neželenimi učinki, ki se pojavljajo pri drugih antidepresivnih zdravilih, npr. z antiholinergičnimi, sedativnimi in srčno-žilnimi neželenimi učinki.
Forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit.
Korist forsirane diureze, dialize, hemoperfuzije in izmenjalne transfuzije je malo verjetna.
If any of these conditions apply to you, please talk with your doctor before taking Efexor.
Če se katera od teh stanj nanašajo za vas, se pogovorite s svojim zdravnikom, preden začnete jemati zdravilo Efexor.
In patients who develop these symptoms, increasing the dose may be detrimental.
Pri bolnikih s temi simptomi, je lahko zvečanje odmerka škodljivo.
It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Ni še popolnoma jasno, kako antidepresivi delujejo, verjetno pa pomagajo zvišati raven serotonina in noradrenalina v možganih.
For prevention of recurrence of major depressive episodes.
Preprečevanje ponovitev hudih depresivnih epizod.
Therefore, any patient receiving venlafaxine should be cautioned about their ability to drive or operate hazardous machinery.
Zato je treba vse bolnike opozoriti, da venlafaksin lahko vpliva na njihove sposobnosti vožnje in upravljanja z nevarnimi stroji.
If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Če se po znižanju odmerka ali po prekinitvi zdravljenja pojavijo neznosni simptomi, je treba pretehtati možnost ponovne uvedbe prej predpisanega odmerka.
• If you have a history of aggressive behaviour.
• če imate agresivno vedenje v anamnezi.
Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission notified the CHMP/EMEA Secretariat of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Zaradi različnih nacionalnih odločitev držav članic o odobritvi dovoljenj za promet z zgoraj navedenim zdravilom (in z njim povezanih imen) je Evropska komisija obvestila tajništvo CHMP/EMEA o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, za razrešitev nesoglasij med nacionalnimi povzetki glavnih značilnosti zdravila in s tem uskladitev različnih povzetkov glavnih značilnosti zdravila v EU.
Given that strong warnings recommending the monitoring of blood pressure for all patients prior to the initiation of treatment were included in Section 4.4, the CHMP agreed that a contraindication in patients with uncontrolled hypertension was not warranted.
Glede na to, da je bilo v poglavje 4.4 vključeno močno opozorilo, ki priporoča spremljanje krvnega tlaka pri vseh bolnikih pred začetkom zdravljenja, se je CHMP strinjal, da kontraindikacija pri bolnikih z nenadzorovano hipertenzijo ni potrebna.
The risk of withdrawal symptoms may be dependent on several factors, including the duration and dose of therapy and the rate of dose reduction.
Tveganje za odtegnitvene učinke je lahko odvisno od mnogih dejavnikov, na primer trajanja zdravljenja, odmerka zdravila in od hitrosti zmanjševanja odmerka.
All patients should be carefully screened for high blood pressure and preexisting hypertension should be controlled before initation of treatment.
Vse bolnike je treba skrbno spremljati glede zvišanega krvnega tlaka, obstoječa hipertenzija pa mora biti pred uvedbo zdravljenja ustrezno zdravljena in nadzorovana.
The usual recommended starting dose is 75 mg per day in divided doses, two or three times a day.
Običajni priporočeni začetni odmerek je 75 mg na dan v razdeljenih odmerkih, dvakrat ali trikrat na dan.
Abrupt discontinuation should be avoided.
Nenadni prekinitvi zdravljenja se je treba izogniti.
If you have liver or kidney problems, talk to your doctor, since your dose of Efexor may need to be different.
Če imate težave z jetri ali ledvicami, se pogovorite z zdravnikom, ker bo morda treba vaš odmerek zdravila Efexor prilagoditi.
If your doctor has prescribed Efexor for a patient under 18, and you want to discuss this, please go back to your doctor.
Če je zdravnik zdravilo Efexor predpisal bolniku, mlajšemu od 18 let, in želite o tem več informacij, se posvetujte s svojim zdravnikom.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Če je takšno zdravljenje kljub temu klinično upravičeno, je treba bolnika skrbno spremljati glede pojava samomorilnih simptomov.
The efficacy and safety of venlafaxine for other indications in children and adolescents under the age of 18 have not been established.
Učinkovitost in varnost venlafaksina za druge indikacije pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
Major depressive episodes
Hude depresivne epizode
Studies with venlafaxine in rats and mice revealed no evidence of carcinogenesis.
Raziskave venlafaksina na podganah in miših niso pokazale nobenih znakov kancerogeneze.
Efexor passes into breast milk.
Zdravilo Efexor prehaja v materino mleko.
In addition, these conditions may be co-morbid with major depressive disorder.
Poleg tega se ta stanja lahko pojavijo sočasno s hudo depresivno motnjo.
It was agreed that “No specific dose adjustments are considered necessary based on patient age alone”.
Dogovorjeno je bilo, da „Samo na podlagi starosti bolnika prilagoditve odmerkov niso potrebne “.
A pharmacokinetic study with indinavir has shown a 28% decrease in AUC and a 36% decrease in Cmax for indinavir.
Farmakokinetična raziskava z indinavirjem je pokazala 28-odstotno zmanjšanje AUC in 36-odstotno znižanje Cmax indinavirja.
If your doctor thinks that you no longer need Efexor, he/she may ask you to reduce your dose slowly, before stopping treatment altogether.
Če vaš zdravnik misli, da zdravila Efexor ne potrebujete več, vam bo počasi zniževal odmerek, preden vam bo zdravljenje popolnoma ukinil.
Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour, and to seek medical advice immediately if these symptoms present.
Bolnike (in skrbnike bolnikov) je treba opozoriti, da morajo biti pozorni na kakršnokoli klinično poslabšanje, pojav samomorilnega vedenja, misli na samomor in pojav neobičajnih vedenjskih sprememb, ter da se morajo v primeru, da se takšni simptomi pojavijo, nemudoma posvetovati z zdravnikom.
In this leaflet:
Ob upoštevanju:
Efexor is a treatment for adults with depression.
Zdravilo Efexor se uporablja za zdravljenje odraslih bolnikov z depresijo.
• If your cholesterol levels get higher.
• če se vam poviša koncentracija holesterola;
For patients that require haemodialysis and in patients with severe renal impairment (GFR < 30 ml/min), the dose should be reduced by 50%.
Pri bolnikih, pri katerih je potrebna hemodializa, in pri bolnikih s hudimi okvarami ledvic (GFR < 30 ml/min), je treba odmerek zmanjšati za 50 %.
These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer.
Po uvedbi zdravljenja z antidepresivi se to lahko še stopnjuje, saj ta zdravila začnejo delovati šele čez nekaj časa, običajno čez dva tedna, včasih tudi kasneje.
Generally, these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Običajno ti simptomi izzvenijo sami v 2 tednih, čeprav lahko pri nekaterih posameznikih trajajo dalj časa (2-3 mesece ali dlje).
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.
Glede varnosti srca in ožilja je bilo sklenjeno, da kontraindikacija ni potrebna ter da zadostuje revidirano besedilo poglavja 4.4.
Medicinal products that inhibit serotonin uptake may lead to reduced platelet function.
Zdravila, ki zavirajo privzem serotonina, lahko zmanjšajo delovanje trombocitov.
Thoughts of suicide and worsening of your depression or anxiety disorder
Misli na samomor in poslabšanje depresije ali anksiozne motnje
[To be completed nationally] 6.6 Special precautions for disposal No special requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
No specific antidotes for venlafaxine are known.
Specifični antidoti za venlafaksin niso poznani.
Major Depressive Episodes: the CHMP considered that the maximum dose of 375mg/day Efexor is safe and effective in a long term perspective and recommended that it is approved without duration limitations in the harmonised SPC.
Hude depresivne epizode: CHMP je menil, da je najvišji odmerek 375 mg/dan zdravila Efexor dolgoročno varen in učinkovit, ter je v usklajenem povzetku glavnih značilnosti zdravila priporočil odobritev brez časovnih omejitev.
If your baby has these symptoms when it is born and you are concerned, contact your doctor and/or midwife who will be able to advise you.
Če se tovrstni učinki pojavijo pri vašem otroku ob rojstvu in vas to skrbi, se obrnite na svojega zdravnika in/ali babico, ki vam bosta lahko svetovala.
Venlafaxine and ODV are minimally bound at therapeutic concentrations to human plasma proteins (27% and 30%, respectively).
Venlafaksin in ODV se v terapevtskih koncentracijah minimalno vežeta na človeške plazemske beljakovine plazme (27 % oziroma 30 %).
It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain.
Menijo, da imajo ljudje, ki so depresivni in/ali anksiozni, nižje vrednosti serotonina in noradrenalina v možganih.
Your doctor should decide whether you can take Efexor with other medicines.
Vaš zdravnik bo presodil, ali lahko jemljete zdravilo Efexor skupaj z drugimi zdravili.
Animal studies regarding reproductive toxicity have found in rats a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation.
V raziskavah toksičnosti za razmnoževanje na živalih so pri podganah ugotovili zmanjšano maso mladičev, povečanje števila mrtvorojenih mladičev in pogostnejšo smrt mladičev v prvih 5 dneh dojenja.
Concomitant administration of venlafaxine and metoprolol to healthy volunteers in a pharmacokinetic interaction study for both medicinal products resulted in an increase of plasma concentrations of metoprolol by approximately 30-40% without altering the plasma concentrations of its active metabolite, α-hydroxymetoprolol.
Pri sočasni uporabi venlafaksina in metoprolola v raziskavi farmakokinetičnih interakcij za obe zdravili pri zdravih prostovoljcih, so se plazemske koncentracije metoprolola povišale za približno 30-40 % brez sprememb plazemskih koncentracij njegovega aktivnega presnovka α-hidroksimetoprolola.
Discontinuation of venlafaxine (particularly when abrupt) commonly leads to withdrawal symptoms.
Ukinitev venlafaksina (še posebej nenadna) pogosto povzroči odtegnitvene simptome.
• If you use other medicines that taken concomitantly with Efexor could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”).
• če jemljete druga zdravila, ki bi lahko pri sočasni uporabi z zdravilom Efexor povečala tveganje za nastanek serotoninskega sindroma (glejte poglavje “Jemanje drugih zdravil”);
Use in children and adolescents under the age of 18 years
Uporaba pri otrocih in mladostnikih, mlajših od 18 let
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Znano je, da pri bolnikih s samomorom povezanimi dogodki v anamnezi, ali bolnikih, ki kažejo znatno stopnjo samomorilne miselnosti pred uvedbo zdravljenja, obstaja večje tveganje za pojav samomorilnih misli ali poskusov samomora in jih je treba med zdravljenjem skrbno spremljati.
The clinical relevance of this finding in hypertensive patients is unknown.
Klinični pomen te ugotovitve pri hipertenzivnih bolnikih ni znan.
• Swelling of the face, throat, hands, or feet
• otekanje obraza, grla, dlani ali stopal;
Not known: swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)
Neznana: otekel obraz ali jezik, kratka sapa ali oteženo dihanje, pogosto s kožnimi izpuščaji (to je lahko resna alergijska reakcija)