FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee concluded however that its concerns had still not been adequately addressed and confirmed its initial negative opinion recommending the refusal of a change to the marketing authorisations.
Slovenian: Kljub temu je odbor sklenil, da njegovi zadržki še vedno niso zadovoljivo odpravljeni ter potrdil svoje prvotno negativno mnenje, s katerim priporoča zavrnitev spremembe dovoljenj za promet z zdravili.
English: Somatic pain is from the body surfaces (such as skin) or musculoskeletal tissues (such as skeletal muscles, bone and joints).
Slovenian: Somatska bolečina izvira s telesnih površin (na primer s kože) ali iz mišično-skeletnih tkiv (kot so skeletne mišice, kosti in sklepi).
English: The CHMP noted that the studies had not proven that duloxetine would provide a relevant benefit in the indication applied for.
Slovenian: Odbor CHMP je ugotovil, da študije niso dokazale, da duloksetin omogoča bistvene koristi pri indikaciji, za katero je bilo vloga vložena.
English: On 21 July 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisations for the duloxetinecontaining medicines Ariclaim, Cymbalta and Xeristar.
Slovenian: Dne 21. julija 2011 je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel negativno mnenje, s katerim priporoča zavrnitev spremembe dovoljenj za promet z zdravili Ariclaim, Cymbalta in Xeristar, ki vsebujejo duloksetin.
English: Since these neurotransmitters are involved in reducing the sensation of pain, blocking their re-uptake into nerve cells may improve the symptoms of pain.
Slovenian: Ker ti nevrotransmitorji sodelujejo pri zmanjševanju občutka bolečine, se lahko z zaviranjem njihovega ponovnega privzema v živčne celice izboljšajo tudi simptomi bolečine.
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Slovenian: Duloksetin z zaviranjem njihovega ponovnega privzema poveča količino teh nevrotrasmitorjev v prostorih med živčnimi celicami, s čimer se poveča stopnja komunikacije med celicami.
English: After considering the grounds for this request, the CHMP re examined the initial opinion, and confirmed the refusal of the change to the marketing authorisations on 17 November 2011.
Slovenian: Po proučitvi utemeljitve za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in 17. novembra 2011 potrdil zavrnitev spremembe za dovoljenja za promet z zdravili.
English: The company presented results of five main studies in 839 patients with chronic somatic pain: two studies in patients with knee pain caused by osteoarthritis (swelling and pain in the joints) and three in patients with chronic low back pain.
Slovenian: Družba je predstavila rezultate petih glavnih študij pri 839 bolnikih s kronično somatsko bolečino: dve študiji pri bolnikih z bolečino v kolenu, ki jo je povzročil osteoartritis (otekanje in bolečina v sklepih) in tri študije pri bolnikih s kronično bolečino v križu.
English: In addition to pain due to diabetic peripheral neuropathy, Cymbalta and Xeristar are also used in major depression and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Slovenian: Poleg zdravljenja bolečin zaradi diabetične periferne nevropatije se zdravili Cymbalta in Xeristar uporabljata tudi pri močni depresiji in generalizirani anksiozni motnji (dolgotrajna tesnoba ali živčnost zaradi vsakodnevnih stvari).
English: It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Slovenian: Deluje tako, da preprečuje ponovni privzem nevrotransmitorjev 5-hidroksitripamina (imenovanega tudi serotonin) in noradrenalina v živčne celice v možganih in hrbtenjači.
English: The company informed the CHMP that there are currently no ongoing clinical trials with Ariclaim, Cymbalta and Xeristar in chronic somatic pain patients in Europe.
Slovenian: Družba je obvestila odbor CHMP, da trenutno v Evropi ne poteka nobeno klinično preskušanje zdravil Ariclaim, Cymbalta in Xeristar pri bolnikih s kronično somatsko bolečino.
English: Ariclaim, Cymbalta and Xeristar are medicines containing the active substance duloxetine.
Slovenian: Ariclaim, Cymbalta in Xeristar so zdravila, ki vsebujejo zdravilno učinkovino duloksetin.
English: What are Ariclaim, Cymbalta and Xeristar?
Slovenian: Kaj so zdravila Ariclaim, Cymbalta in Xeristar?
English: The active substance duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Slovenian: Zdravilna učinkovina duloksetin je zaviralec ponovnega privzema serotonina in noradrenalina.
English: Ariclaim is used to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Slovenian: Zdravilo Ariclaim se uporablja za zdravljenje bolečin zaradi diabetične periferne nevropatije (poškodbe živcev v okončinah, ki se pojavljajo pri bolnikih s sladkorno boleznijo).
English: What did the company present to support its application?
Slovenian: Katero dokumentacijo je družba predložila odboru CHMP v podporo svoji vlogi?
English: During the re-examination, the Committee considered the use of duloxetine in a smaller group of patients: patients with chronic low back pain or osteoarthritis (swelling and pain in the joints) of at least moderate severity who cannot use NSAIDS.
Slovenian: V času ponovnega pregleda je odbor proučeval uporabo duloksetina pri manjši skupini bolnikov: bolnikov s kronično bolečino v križu ali osteoartritisom (otekanjem in bolečinami v sklepih) vsaj zmerne resnosti, ki ne jemljejo redno nesteroidnih antirevmatikov.
English: There are no consequences on the use of these medicines in their approved indications, for which the balance of benefits and risks remains unchanged.
Slovenian: Zavrnitev nima nobenih posledic za uporabo zdravil Ariclaim, Cymbalta in Xeristar za odobrene indikacije, pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
English: Patients in the studies were treated with duloxetine or placebo (a dummy treatment) with some patients taking them in combination with NSAIDs.
Slovenian: Bolniki v študijah so bili zdravljeni z duloksetinom ali placebom (zdravilom brez zdravilne učinkovine), nekateri bolniki pa so ju jemali v kombinaciji z nesteroidnimi antirevmatiki.
English: In addition to their approved uses, the three medicines were expected to be used to treat moderate to severe chronic (long-term) somatic pain in patients not regularly taking NSAID pain killers (non steroidal anti-inflammatory drugs).
Slovenian: Poleg odobrenih načinov uporabe so nameravali vsa tri zdravila uporabljati za zdravljenje zmerne do hude kronične (dolgotrajne) somatske bolečine pri bolnikih, ki ne jemljejo protibolečinskih zdravil NSAID (nesteroidnih antirevmatikov).
English: The change concerned the addition of a new indication, the treatment of moderate to severe chronic somatic pain in patients not taking NSAIDs regularly.
Slovenian: Sprememba se je nanašala na dodatek nove indikacije, zdravljenja zmerne do hude kronične somatske bolečine pri bolnikih, ki ne jemljejo redno nesteroidnih antirevmatikov.
English: The CHMP therefore concluded that the benefits of duloxetine in the treatment of moderate to severe chronic somatic pain in patients not regularly taking NSAIDs had not been shown to outweigh its risks.
Slovenian: Odbor CHMP je zato sklenil, da dokazane koristi duloksetina pri zdravljenju zmerne do hude kronične somatske bolečine pri bolnikih, ki ne jemljejo redno nesteroidnih antirevmatikov, večje od z njim povezanih tveganj.
English: What is happening with Ariclaim, Cymbalta and Xeristar for in their approved indications?
Slovenian: Kaj to pomeni za nadaljnjo uporabo zdravil Ariclaim, Cymbalta in Xeristar za njihove odobrene indikacije?
English: MA (EU) number (Invented) name
Slovenian: Številka EU Zaščiteno ime
English: Immediate Packaging
Slovenian: Pot uporabe ovojnina vsebina Velikost pakiranja
English: Content (concentration)
Slovenian: 360 (3 x 120) tablet
English: The trials and programmes will continue as planned.
Slovenian: Raziskave in programi se bodo nadaljevali v skladu z načrti.
English: International Non-proprietary Name (INN): agomelatine
Slovenian: Mednarodno nelastniško ime (INN): agomelatin
English: They looked at the short- and long-term effectiveness of the medicine (short-term studies lasting 6-8 weeks and the longterm studies lasting up to a year).
Slovenian: Preučevali so kratkoročno in dolgoročno učinkovitost zdravila (kratkoročne raziskave so trajale 6 do 8 tednov, dolgoročne pa do enega leta).
English: • The long-term study did not show that the medicine was effective.
Slovenian: • dolgoročna raziskava ni dokazala učinkovitosti zdravila;
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če ste vključeni v klinično raziskavo ali program sočutne uporabe ter potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: In major depressive disorder, patients have disturbances of mood that interfere with their everyday life.
Slovenian: Pri hudi depresivni motnji imajo bolniki motnje razpoloženja, ki vplivajo na njihovo vsakodnevno življenje.
English: The effectiveness was measured by looking at the score in the HAM-D rating scale before and at the end of the study.
Slovenian: Učinkovitost so merili z določanjem rezultata na ocenitveni lestvici HAM-D pred in ob koncu raziskave.
English: The applicant requested a reexamination of the opinion, but withdrew this request before the CHMP completed the re-examination.
Slovenian: Vlagatelj je zahteval ponovno presojo mnenja, vendar je, še preden je CHMP zaključil ponovno presojo, svojo zahtevo umaknil.
English: The company that applied is Les Laboratoires Servier.
Slovenian: Vlagatelj je podjetje Les Laboratoires Servier.
English: The key symptoms are depressed mood and loss/diminished interest or pleasure.
Slovenian: Glavni simptomi so slabo razpoloženje in izguba/zmanjšanje zanimanja ali veselja.
English: The effects of agomelatine were first tested in experimental models before being studied in humans.
Slovenian: Učinki agomelatina so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
English: EMEA/37021/2007 - update
Slovenian: EMEA/522446/2006 - posodobitev
English: London, 18 November 2006 Doc.Ref.
Slovenian: London, 16/01/2007 Ref. dok.
English: What were the major concerns that led to the CHMP to recommend a refusal of the marketing authorisation?
Slovenian: Kateri so bili glavni zadržki, zaradi katerih je CHMP predlagal zavrnitev dovoljenja za promet?
English: Patients often suffer relapses (when the disease comes back after it has been treated).
Slovenian: Pogoste so ponovitve (ko se bolezen po zdravljenju ponovi).
English: All patients treated suffered from a major depressive disorder, the severity of which was assessed using a standard rating scale (the Hamilton Rating Scale for Depression, HAM-D).
Slovenian: Vsi zdravljeni bolniki so bolehali za hudo depresivno motnjo, katere resnost so ocenili na podlagi standardne ocenitvene lestvice (Hamiltonove lestvice za ocenjevanje depresije, HAM-D).
English: See here for information on the outcome of the resubmission
Slovenian: Za informacije o zaključku postopka za ponovno predloženo vlogo glejte tukaj.
English: They may suffer from deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, changes in weight.
Slovenian: Trpeti utegnejo za globoko žalostjo, občutkom ničvrednosti, izgubo zanimanja za stvari, ki so jih prej veselile, motnjami spanja, občutkom splošne upočasnjenosti, občutkom anksioznosti, spremembami telesne mase.
English: Some studies included a control group where patients were treated with fluoxetine or paroxetine (other medicines used in depression).
Slovenian: Nekatere raziskave so vključevale kontrolno skupino, v kateri so bili bolniki zdravljeni s fluoksetinom ali paroksetinom (drugimi zdravili za zdravljenje depresije).
English: What documentation has been presented by the company to support the application to the CHMP?
Slovenian: Katero dokumentacijo je podjetje predložilo CHMP v podporo svoji vlogi ?
English: This means that agomelatine stimulates the melatonin receptors MT1 and MT2 (these receptors are normally activated by a natural hormone, melatonin) and it blocks the 5-HT2C receptors (these receptors are normally activated by a chemical messenger, serotonin).
Slovenian: To pomeni, da agomelatin stimulira melatoninske receptorje MT1 in MT2 (te receptorje normalno aktivira naravni hormon melatonin) ter zavira receptorje 5-HT2C (te receptorje normalno aktivira kemični prenašalec serotonin).
English: The main studies involved more than 2,400 patients that took Valdoxan/Thymanax.
Slovenian: Glavne raziskave so vključevale več kot 2400 bolnikov, ki so prejeli zdravilo Valdoxan/Thymanax.
English: On 27 July 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a marketing authorisation for the medicinal product Valdoxan/Thymanax, 25 mg film-coated tablets intended for the treatment of major depressive disorder.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v negativnem mnenju z dne 27. julija 2006 priporočil zavrnitev dovoljenja za promet z zdravilom Valdoxan/Thymanax, 25 mg filmsko obloženih tablet, namenjenih za zdravljenje hude depresivne motnje.
English: QUESTIONS AND ANSWERS ON RECOMMENDATION FOR REFUSAL OF MARKETING AUTHORISATION for VALDOXAN/THYMANAX
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE PRIPOROČILA ZA ZAVRNITEV VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo VALDOXAN/THYMANAX
English: Valdoxan/Thymanax was expected to be used in adult patients to treat major depressive disorder.
Slovenian: Zdravilo Valdoxan/Thymanax bi se naj uporabljalo za zdravljenje hude depresivne motnje pri odraslih bolnikih.
English: The major concern of the CHMP was that the effectiveness of Valdoxan/Thymanax had not been sufficiently shown:
Slovenian: Glavni zadržek CHMP je bilo dejstvo, da učinkovitost zdravila Valdoxan/Thymanax ni bila dokazana v zadostni meri:
English: What is Valdoxan/Thymanax?
Slovenian: Kaj je Valdoxan/Thymanax?
English: Valdoxan/Thymanax was compared with a placebo (a dummy treatment).
Slovenian: Zdravilo Valdoxan/Thymanax so primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: Valdoxan/Thymanax are orange-yellow tablets containing 25 mg of the active substance agomelatine.
Slovenian: Zdravilo Valdoxan/Thymanax so oranžno-rumene tablete, ki vsebujejo 25 mg zdravilne učinkovine agomelatin.
English: The active substance in Valdoxan/Thymanax, agomelatine, is a ‘melatonergic agonist' and a ‘5-HT2C antagonist'.
Slovenian: Zdravilna učinkovina v zdravilu Valdoxan/Thymanax, agomelatin, je melatoninski agonist in antagonist avtoreceptorjov 5-HT2C.
English: At this point in time, the CHMP was of the opinion that the benefits of Valdoxan/Thymanax did not outweigh its risks.
Slovenian: Ob tem času je bil CHMP mnenja, da koristi zdravila Valdoxan/Thymanax ne presegajo z njim povezanih tveganj.
English: The Company has informed the CHMP that there are no consequences on patients currently included in clinical trials or compassionate use programmes with Valdoxan/Thymanax.
Slovenian: Podjetje je CHMP obvestilo, da za bolnike, ki so vključeni v klinične raziskave ali programe sočutne uporabe zdravila Valdoxan/Thymanax, posledic ni.
English: What are the consequences of the refusal for patients undergoing clinical trials/compassionate use programmes with Valdoxan/Thymanax?
Slovenian: Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih raziskavah zdravila Valdoxan/Thymanax?
English: Hence, the CHMP recommended that Valdoxan/Thymanax be refused marketing authorisation.
Slovenian: Iz tega razloga je CHMP priporočil zavrnitev dovoljenja za promet z zdravilom Valdoxan/Thymanax.
English: • The short-term studies showed that the medicine has an effect, but the extent of this did not allow the Committee to draw a firm conclusion on the medicine's effectiveness The CHMP had no special concerns regarding the side effects associated with Valdoxan/Thymanax, as these could have been managed using the standard risk management tools.
Slovenian: • kratkoročne raziskave sicer so pokazale, da zdravilo ima učinek, vendar obseg tega učinka ni bil zadosten, da bi Odbor lahko prišel do trdnega sklepa glede učinkovitosti zdravila.
English: What was Valdoxan/Thymanax expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Valdoxan/Thymanax uporabljalo?
English: How is Valdoxan/Thymanax expected to work?
Slovenian: Kako naj bi zdravilo Valdoxan/Thymanax delovalo?
English: The maximum recommended dosing frequency is one tablet per day.
Slovenian: Največja priporočena pogostnost odmerjanja je ena tableta na dan.
English: It is available as film-coated tablets (25, 50 and 100 mg) and as orodispersible tablets (25, 50 and 100 mg).
Slovenian: Na voljo je v obliki filmsko obloženih (25, 50 in 100 mg) in orodisperzibilnih tablet (25, 50 in 100 mg).
English: The recommended dose of Vizarsin is 50 mg taken as needed about one hour before sexual activity.
Slovenian: Priporočeni odmerek zdravila Vizarsin je 50 mg, ki se vzame po potrebi eno uro pred spolnim odnosom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vizarsin on 21 September 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vizarsin, veljavno po vsej Evropski uniji, odobrila dne 21. septembra 2009.
English: The full EPAR for Vizarsin 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 Vizarsin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What are the benefits and risks of Vizarsin?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Vizarsin?
English: This means that Vizarsin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Viagra.
English: For more information about treatment with Vizarsin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vizarsin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a summary of the European public assessment report (EPAR) for Vizarsin.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vizarsin.
English: Vizarsin is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Slovenian: Zdravilo Vizarsin se uporablja za zdravljenje erektilne disfunkcije (imenovane tudi impotenca) pri odraslih moških, kadar ne zmorejo doseči ali ohraniti take erekcije penisa, ki omogoča zadovoljivo spolno dejavnost.
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 Vizarsin.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Vizarsin, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The Committee recommended that Vizarsin be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Vizarsin odobri dovoljenje za promet.
English: Other information about Vizarsin
Slovenian: Druge informacije o zdravilu Vizarsin
English: Because Vizarsin is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Slovenian: Ker je zdravilo Vizarsin generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Orodispersible means that the tablet dissolves in the mouth.
Slovenian: Orodisperzibilne tablete so tablete, ki se raztopijo v ustih.
English: By blocking the breakdown of cGMP, Vizarsin restores erectile function.
Slovenian: Z zaviranjem razgradnje cGMP zdravilo Vizarsin ponovno vzpostavi erektilno funkcijo.
English: The active ingredient in Vizarsin, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Slovenian: Zdravilna učinkovina v zdravilu Vizarsin, sildenafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5).
English: The CHMP concluded that, in accordance with EU requirements, Vizarsin has been shown to have comparable quality and to be bioequivalent to Viagra.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Vizarsin primerljivo raven kakovosti kot zdravilo Viagra ter da mu je biološko enakovredno.
English: Vizarsin is a ‘generic medicine'.
Slovenian: Zdravilo Vizarsin je „generično zdravilo“.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
Slovenian: Med normalnim spolnim vzburjenjem se cGMP tvori v penisu, kjer povzroča, da se gobasto tkivo penisa (corpora cavernosa) sprosti.
English: This allows blood to flow into the corpora, producing the erection.
Slovenian: To omogoči večji dotok krvi v gobasto tkivo, kar povzroči erekcijo.
English: Vizarsin is a medicine that contains the active substance sildenafil.
Slovenian: Vizarsin je zdravilo, ki vsebuje zdravilno učinkovino sildenafil.
English: Because Vizarsin is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Slovenian: Ker je zdravilo Vizarsin generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Viagra.
English: Why has Vizarsin been approved?
Slovenian: Zakaj je bilo zdravilo Vizarsin odobreno?
English: If Vizarsin is taken with food, the onset of activity may be delayed compared with taking Vizarsin without food.
Slovenian: Če se zdravilo Vizarsin zaužije s hrano, lahko začne delovati pozneje, kot če se zaužije brez nje.
English: The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects.
Slovenian: Odmerek zdravila se lahko glede na učinkovitost in neželene učinke poveča na največ 100 mg ali zmanjša na 25 mg. Bolniki z zmanjšanim delovanjem jeter ali močno zmanjšanim delovanjem ledvic morajo zdravljenje začeti s 25-miligramskim odmerkom.
English: Therefore, the CHMP's view was that, as for Viagra, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da koristi zdravila, tako kot pri zdravilu Viagra, odtehtajo znana tveganja.
English: What is Vizarsin used for?
Slovenian: Za kaj se zdravilo Vizarsin uporablja?
English: How has Vizarsin been studied?
Slovenian: Kako je bilo zdravilo Vizarsin raziskano?
English: For Vizarsin to be effective, sexual stimulation is required.
Slovenian: Zdravilo Vizarsin je učinkovito le ob spolnem vzburjenju.
English: How does Vizarsin work?
Slovenian: Kako zdravilo Vizarsin deluje?
English: What is Vizarsin?
Slovenian: Kaj je zdravilo Vizarsin?
English: How is Vizarsin used?
Slovenian: Kako se zdravilo Vizarsin uporablja?
English: One death occurred in each group.
Slovenian: V vsaki skupini je prišlo do ene smrti.
English: Alcohol may modify or increase the effect of other medicines.
Slovenian: Alkohol lahko spremeni ali okrepi učinke drugih zdravil.