FrancophonIA/ELRC3.0 huggingface dataset:
English: P-value (vs. placebo)a p<0.0001
Slovenian: p-vrednost (v primerjavi s placebom)a p = 0,0001
English: 75% Responder Rate MHD
Slovenian: 75-odstotni odziv pri MHD
English: − Do not rub the injection site or re-use the pre-filled pen.
Slovenian: − Mesta injiciranja ne smete drgniti, prav tako pa napolnjenega injekcijskega peresnika ne smete ponovno uporabiti.
English: Step 2: How to inject a) Remove the protective cap and do not replace.
Slovenian: 2. korak: Postopek injiciranja a) Odstranite zaščitni pokrovček ter ga zavrzite.
English: − You may see small air bubbles in the pre-filled pen.
Slovenian: − V napolnjenem injekcijskem peresniku lahko opazite majhne zračne mehurčke.
English: AJOVY must be discarded if it has been out of the refrigerator for longer than 24 hours.
Slovenian: Če je zdravilo AJOVY zunaj hladilnika dlje kot 24 ur, ga morate zavreči.
English: AJOVY 225 mg solution for injection in pre-filled syringe AJOVY 225 mg solution for injection in pre-filled pen
Slovenian: AJOVY 225 mg raztopina za injiciranje v napolnjeni injekcijski brizgi AJOVY 225 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Pack sizes of 1 or 3 pre-filled syringes.
Slovenian: Pakiranja, ki vsebujejo 1 ali 3 napolnjene injekcijske brizge.
English: The expiration date has passed.
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: • Do not shake the pre-filled syringe.
Slovenian: • Napolnjene injekcijske brizge ne smete stresati.
English: How AJOVY works
Slovenian: Kako deluje zdravilo AJOVY
English: ANNEX II A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: Each pre-filled syringe contains 1.5 mL solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 1,5 ml raztopine.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - NAPOLNJENA INJEKCIJSKA BRIZGA
English: Teva Nederland B.V. Tel: +31 800 022 8400
Slovenian: Tel: +31 800 022 8400
English: EU/1/19/1358/001 1 pre-filled syringe EU/1/19/1358/002 3 pre-filled syringes
Slovenian: EU/1/19/1358/001 1 napolnjena injekcijska brizga EU/1/19/1358/002 3 napolnjene injekcijske brizge
English: 50% Responder Rate MHD
Slovenian: 50-odstotni odziv pri MHD
English: The pre-filled syringe and the pre-filled pen should not be shaken.
Slovenian: Napolnjene injekcijske brizge in napolnjenega injekcijskega peresnika ne smete stresati.
English: What AJOVY is used for
Slovenian: Za kaj uporabljamo zdravilo AJOVY
English: − 1 gauze pad or cotton ball per injection
Slovenian: − 1 gazo ali kos vate za vsako injiciranje,
English: − Do not put the cap back on the needle at any time to avoid injury and infection.
Slovenian: − Na iglo ne smete nikoli ponovno dati pokrovčka, da preprečite poškodbe in okužbo.
English: − Do not put the needle cap back on the pre-filled syringe, to avoid injury and infection.
Slovenian: − Pokrovčka igle ne smete dati nazaj na napolnjeno injekcijsko brizgo, da preprečite poškodbe in okužbo.
English: For all episodic and chronic migraine patients, efficacy was sustained for up to 12 additional months in the long-term study (Study 3), in which patients received 225 mg fremanezumab monthly or 675 mg quarterly.
Slovenian: V dolgoročni študiji (študiji 3), v kateri so bolniki prejemali 225 mg fremanezumaba mesečno ali 675 mg fremanezumaba četrtletno, se je pri vseh bolnikih z epizodno in kronično migreno učinkovitost ohranila do 12 dodatnih mesecev.
English: Fremanezumab 675 mg quarterly
Slovenian: 675 mg četrtletno
English: Fremanezumab is highly specific for CGRP and does not bind to closely related family members (e.g., amylin, calcitonin, intermedin and adrenomedullin).
Slovenian: Fremanezumab se zelo specifično veže na CGRP in se ne veže na sorodne peptide iz iste družine (npr.
English: Baseline (SD) P-value (vs. placebo)a p<0.0001
Slovenian: p-vrednost (v primerjavi s placebom)a p < 0,0001
English: Disodium ethylenediaminetetraacetic acid (EDTA) dihydrate Polysorbate 80 (E 433)
Slovenian: L-histidinijev klorid monohidrat saharoza dinatrijeva etilendiaminotetraocetna kislina (EDTA) dihidrat polisorbat 80 (E 433) voda za injekcije
English: Read the “Instructions for Use” for the pre-filled syringe carefully before using AJOVY.
Slovenian: Pred uporabo zdravila AJOVY preberite „Navodila za uporabo“ napolnjene injekcijske brizge.
English: Package leaflet: Information for the patient AJOVY 225 mg solution for injection in pre-filled syringe fremanezumab This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo AJOVY 225 mg raztopina za injiciranje v napolnjeni injekcijski brizgi fremanezumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: MIDAS total
Slovenian: Skupen rezultat na vprašalniku MIDAS
English: EU/1/19/1358/003 1 pre-filled pen EU/1/19/1358/004 3 pre-filled pens
Slovenian: EU/1/19/1358/003 1 napolnjeni injekcijski peresnik EU/1/19/1358/004 3 napolnjeni injekcijski peresniki
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED PEN
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - NAPOLNJENI INJEKCIJSKI PERESNIK
English: Fremanezumab 225 mg monthly with 675 mg starting dose
Slovenian: 225 mg mesečno z začetnim odmerkom
English: (see Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: (navedeno v poglavju 6).
English: EU/1/19/1358/001 - 1 pre-filled syringe EU/1/19/1358/002 - 3 pre-filled syringes Pre-filled pen
Slovenian: Napolnjena injekcijska brizga EU/1/19/1358/001 - 1 napolnjena injekcijska brizga EU/1/19/1358/002 - 3 napolnjene injekcijske brizge Napolnjeni injekcijski peresnik EU/1/19/1358/003 - 1 napolnjeni injekcijski peresnik EU/1/19/1358/004 - 3 napolnjeni injekcijski peresniki
English: When initiating treatment with fremanezumab, concomitant migraine preventive treatment may be continued if considered necessary by the prescriber (see section 5.1).
Slovenian: če zdravnik, ki zdravilo predpisuje, to oceni za potrebno (glejte poglavje 5.1).
English: − Do not put the protective cap back on the pre-filled pen, to avoid injury and infection.
Slovenian: Ne zvijajte ga. − Zaščitnega pokrovčka ne smete dati nazaj na napolnjeni injekcijski peresnik, da preprečite poškodbe in okužbo.
English: Treatment difference is based on the MMRM analysis with treatment, gender, region, and baseline preventive medication use (yes/no), month, and treatment month as fixed effects and corresponding baseline value and years since onset of migraine as covariates.
Slovenian: Povprečna sprememba in intervali zaupanja pri vseh opazovanih dogodkih temeljijo na modelu ANCOVA, ki je vključeval zdravljenje, spol, regijo in uporabo zdravil za preprečevanje migrene ob izhodišču (da/ne) kot fiksne učinke ter ustrezno izhodiščno vrednost in število let od prvega pojava migrene kot sospremenljivki.
English: Fremanezumab 225 mg monthly
Slovenian: 225 mg mesečno
English: One pre-filled syringe contains 225 mg fremanezumab.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 225 mg fremanezumaba.
English: Table 1: Adverse reactions in clinical studies MedDRA System Organ Class Frequency
Slovenian: Preglednica 1: Neželeni učinki v kliničnih študijah
English: • 225 mg once monthly (monthly dosing) or
Slovenian: • 225 mg enkrat na mesec (mesečno odmerjanje) ali • 675 mg vsake tri mesece (četrtletno odmerjanje).
English: In patients who had previously used topiramate the treatment difference for the reduction of monthly migraine days (MMD) observed between fremanezumab 675 mg quarterly and placebo was -2.3 days (95% CI: -3.64, -1.00) and between fremanezumab 225 mg monthly and placebo -2.4 days (95% CI: -3.61, -1.13).
Slovenian: Pri bolnikih, ki so predhodno uporabljali topiramat, je razlika zaradi zdravljenja pri zmanjšanju števila migrenskih dni (MMD), ki so jo opazili med fremanezumabom v odmerku 675 mg četrtletno in placebom, znašala -2,3 dneva (95-odstotni IZ: -3,64, -1,00), med fremanezumabom v odmerku 225 mg mesečno in placebom pa -2,4 dneva (95-odstotni IZ: -3,61; -1,13).
English: Mean changea (95% CI) Baseline (SD) P-value (vs. placebo)a p=0.0023
Slovenian: p-vrednost (v primerjavi s placebom)a p = 0,0023
English: The observed treatment difference for the reduction of monthly headache days (MHD) of at least moderate severity between fremanezumab 675 mg quarterly and placebo in these patients was -2.2 days (95% CI: -3.14, -1.22) and between fremanezumab 225 mg monthly with 675 mg starting dose and placebo -2.7 days (95% CI: -3.71, -1.78).
Slovenian: V nadaljevalni analizi je razlika zaradi zdravljenja pri zmanjšanju števila dni vsaj zmerno hudega glavobola (MHD), ki so jo opazili med fremanezumabom v odmerku 675 mg četrtletno in placebom, pri teh bolnikih znašala -2,2 dneva (95-odstotni IZ: -3,14, -1,22), med fremanezumabom v odmerku 225 mg mesečno z začetnim odmerkom 675 mg in placebom pa -2,7 dneva (95-odstotni IZ: -3,71, -1,78).
English: Approximately twice as much exposure is expected in the lowest body weight quartile (43.5 to 60.5 kg) compared to the highest body weight quartile (84.4 to131.8 kg).
Slovenian: do 60,5 kg) je pričakovati približno dvakrat večjo izpostavljenost kot v zgornjem kvartilu telesne mase
English: Instructions for Use AJOVY 225 mg solution for injection in pre-filled syringe fremanezumab
Slovenian: Navodila za uporabo AJOVY 225 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku fremanezumab
English: − Do not put the protective cap back on the pre-filled pen at any time to avoid injury and infection.
Slovenian: − Na napolnjeni injekcijski peresnik ne smete nikoli ponovno dati zaščitnega pokrovčka, da preprečite poškodbe in okužbo.
English: • Each AJOVY pre-filled syringe contains 225 mg of fremanezumab.
Slovenian: • Ena napolnjena injekcijska brizga zdravila AJOVY vsebuje 225 mg fremanezumaba.
English: In patients who had previously used topiramate the treatment difference for the reduction of monthly headache days (MHD) of at least moderate severity observed between fremanezumab 675 mg quarterly and placebo was -2.7 days (95% CI: -3.88, -1.51) and between fremanezumab 225 mg monthly with 675 mg starting dose and placebo -2.9 days (95% CI: -4.10, -1.78).
Slovenian: Pri bolnikih, ki so predhodno uporabljali topiramat, je razlika zaradi zdravljenja pri zmanjšanju števila dni vsaj zmerno hudega glavobola (MHD), ki so jo opazili med fremanezumabom v odmerku 675 mg četrtletno in placebom, znašala -2,7 dneva (95-odstotni IZ: -3,88, -1,51), med fremanezumabom v odmerku 225 mg mesečno z začetnim odmerkom 675 mg in placebom pa -2,9 dneva (95-odstotni IZ: -4,10; -1,78).
English: In patients on one other concomitant, migraine preventive medicinal product, the treatment difference for the reduction of monthly headache days (MHD) of at least moderate severity observed between fremanezumab 675 mg quarterly and placebo was -1.3 days (95% CI: -2.66, 0.03) and between fremanezumab 225 mg monthly with 675 mg starting dose and placebo -2.0 days (95% CI: -3.27, -0.67).
Slovenian: Pri bolnikih, ki so uporabljali eno drugo sočasno zdravilo za preprečevanje migrene, je razlika zaradi zdravljenja pri zmanjšanju števila dni vsaj zmerno hudega glavobola (MHD), ki so jo opazili med fremanezumabom v odmerku 675 mg četrtletno in placebom, znašala -1,3 dneva (95-odstotni IZ:2,66, 0,03), med fremanezumabom v odmerku 225 mg mesečno z začetnim odmerkom 675 mg in placebom pa -2,0 dneva (95-odstotni IZ: -3,27, -0,67).
English: Injection site pain Injection site induration Injection site erythema
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti bolečina na mestu injiciranja induracija na mestu injiciranja eritem na mestu injiciranja pogosti pruritus na mestu injiciranja občasni izpuščaj na mestu injiciranja
English: b) Ask your doctor, pharmacist or nurse how to throw away the container.
Slovenian: Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, če po injiciranju zdravila AJOVY
English: The medicine is cloudy, discoloured, or contains particles.
Slovenian: injekcijska brizga izgleda poškodovana, pretekel je rok uporabnosti, zdravilo je motno, obarvano ali vsebuje delce.
English: AJOVY 225 mg solution for injection in pre-filled syringe fremanezumab
Slovenian: AJOVY 225 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku fremanezumab
English: How to store AJOVY
Slovenian: Shranjevanje zdravila AJOVY
English: In patients on one other concomitant, migraine preventive medicinal product, the treatment difference for the reduction of monthly migraine days (MMD) observed between fremanezumab 675 mg quarterly and placebo was -1.8 days (95% CI: -2.95, -0.55) and between fremanezumab 225 mg monthly and placebo -2.0 days (95% CI: -3.21, -0.86).
Slovenian: Pri bolnikih, ki so uporabljali eno drugo sočasno zdravilo za preprečevanje migrene, je razlika zaradi zdravljenja pri zmanjšanju števila migrenskih dni (MMD), ki so jo opazili med fremanezumabom v odmerku 675 mg četrtletno in placebom, znašala -1,8 dneva (95-odstotni IZ: -2,95, -0,55), med fremanezumabom v odmerku 225 mg mesečno in placebom pa -2,0 dneva (95-odstotni IZ: -3,21;
English: Month 3
Slovenian: 4 dni na mesec.
English: In patients who had previously used onabotulinumtoxin A the treatment difference for the reduction of monthly headache days (MHD) of at least moderate severity observed between fremanezumab 675 mg quarterly and placebo was -1.3 days (95% CI: -3.01, -0.37) and between fremanezumab 225 mg monthly with 675 mg starting dose and placebo -2.0 days (95% CI: -3.84, -0.22).
Slovenian: Pri bolnikih, ki so predhodno uporabljali onabotulinski toksin tipa A, je razlika zaradi zdravljenja pri zmanjšanju števila dni vsaj zmerno hudega glavobola (MHD), ki so jo opazili med fremanezumabom v odmerku 675 mg četrtletno in placebom, znašala -1,3 dneva (95-odstotni IZ:3,01, -0,37), med fremanezumabom v odmerku 225 mg mesečno z začetnim odmerkom 675 mg in placebom pa -2,0 dneva (95-odstotni IZ: -3,84; -0,22).
English: − Do not inject AJOVY into an area that is tender, red, hot, bruised, hardened, tattooed or that has scars or stretch marks.
Slovenian: poškodovan, otrdel, tetoviran ali prekrit z brazgotinami ali strijami.
English: One pre-filled pen contains 225 mg fremanezumab.
Slovenian: En napolnjeni injekcijski peresnik vsebuje 225 mg fremanezumaba.
English: − 1 sharps disposal or puncture-resistant container b) Place the supplies you have gathered on a clean, flat surface.
Slovenian: b) Pripravljene pripomočke postavite na čisto in ravno podlago.
English: • Each AJOVY pre-filled pen contains 225 mg of fremanezumab.
Slovenian: • En napolnjeni injekcijski peresnik zdravila AJOVY vsebuje 225 mg fremanezumaba.
English: Injection site pruritus
Slovenian: srbenje na mestu injiciranja
English: Uncommon (may affect up to 1 in 100 people) Rash at the injection site
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: The efficacy of fremanezumab was evaluated in episodic migraine in a randomised, multicentre, 12-week, placebo-controlled, double-blind study (Study 1).
Slovenian: 12-tedenski, s placebom nadzorovani, dvojno slepi študiji (študija 1).
English: Keep the pre-filled syringe in the outer carton to protect the medicine from light.
Slovenian: Napolnjene injekcijske brizge shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: --1 Live recombinant turkey herpesvirus (strain HVT/ILT-138) expressing the glycoproteins gD and gI of infectious laryngotracheitis virus: 103.1 - 104.1 PFU*.
Slovenian: --1 - živ rekombinanten puranji herpes virus (sev HVT/ILT-138) z izraženima proteinoma gD in gI virusa kužnega laringotraheitisa 103.1 - 104.1 PFU * *PFU - enote, ki tvorijo plak
English: EU (MA) number Invented name
Slovenian: EMEA številka Izmišljeno ime Jakost Farmacevtska oblika
English: 10 % Oral powder
Slovenian: 10 % Peroralni prašek.
English: Packaging Package size
Slovenian: Pakiranje Velikost pakiranja
English: Date of first authorisation: 21 September 2009 Date of latest renewal: 16 May 2014
Slovenian: Datum prve odobritve: 21. september 2009 Datum zadnjega podaljšanja: 16. maj 2014
English: Use in adults:
Slovenian: Uporaba pri odraslih:
English: - If you are taking riociguat.
Slovenian: - Če jemljete riociguat.
English: Swallow the tablet whole with a glass of water.
Slovenian: Celo tableto pogoltnite s kozarcem vode.
English: It is not possible to determine whether these events were directly related to Vizarsin.
Slovenian: Ni mogoče ugotoviti, ali so bili ti dogodki neposredno povezani z zdravilom Vizarsin.
English: Use in patients using other medicines:
Slovenian: Uporaba pri bolnikih, ki jemljejo druga zdravila:
English: You should not take Vizarsin more than once a day.
Slovenian: Zdravila Vizarsin ne smete vzeti več kot enkrat na dan.
English: Further information on clinical trials
Slovenian: Dodatne informacije o kliničnih preizkušanjih
English: - If you have recently had a stroke or a heart attack, or if you have low blood pressure.
Slovenian: - Če ste nedavno doživeli možgansko kap ali srčni infarkt ali če imate nizek krvni tlak.
English: Do not take Vizarsin with other medicines unless your doctor tells you that you can.
Slovenian: Zdravila Vizarsin ne jemljite skupaj z drugimi zdravili, razen če vam zdravnik pove, da ga lahko.
English: These reports included dizziness and light-headedness, but not syncope.
Slovenian: V teh poročilih sta bili navedeni omotica in rahla vrtoglavica, ne pa sinkope.
English: In order for Vizarsin to be effective, sexual stimulation is required.
Slovenian: Da bi bilo zdravilo Vizarsin učinkovito, je potrebna spolna stimulacija.
English: Very common (may affect more than 1 in 10 people): headache.
Slovenian: Zelo pogost (pojavi se lahko pri več kot 1 od 10 bolnikov): glavobol.
English: There are no adequate and well-controlled studies in pregnant or breastfeeding women.
Slovenian: Ni zadostnih in dobro nadzorovanih študij pri nosečnicah in doječih ženskah.
English: In clinical trials sildenafil was administered to more than 8000 patients aged 19-87.
Slovenian: V kliničnih preizkušanjih je sildenafil dobivalo več kot 8000 bolnikov, starih od 19 do 87 let.
English: The amount of time Vizarsin takes to work varies from person to person, but it normally takes between half an hour and one hour.
Slovenian: Čas, ki je potreben za začetek delovanja zdravila Vizarsin, se od posameznika do posameznika razlikuje, ponavadi pa traja od pol ure do ene ure.
English: Doses above 100 mg do not increase the efficacy.
Slovenian: Odmerek, večji od 100 mg, ne poveča učinkovitosti zdravila.
English: - A sudden decrease or loss of vision - this occurs rarely
Slovenian: - Nenadno poslabšanje ali izguba vida - to se zgodi redko
English: Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of sildenafil without sexual activity.
Slovenian: Za številne dogodke je bilo opisano, da so se zgodili med spolnim odnosom ali kmalu po njem, nekateri pa so se pojavili kmalu po uporabi sildenafila, brez spolne dejavnosti.
English: Your doctor may decide on a lower dose for you.
Slovenian: Morda vam bo določil manjši odmerek.
English: In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms.
Slovenian: Poleg tega morajo zdravniki bolnikom svetovati, kaj naj storijo, če se pojavijo simptomi posturalne hipotenzije.
English: The safety and efficacy of sildenafil was maintained in long-term studies.
Slovenian: Varnost in učinkovitost sildenafila sta se ohranili tudi v dolgoročnih preizkušanjih.
English: What Vizarsin is and what it is used for
Slovenian: Kaj je zdravilo Vizarsin in za kaj ga uporabljamo
English: - If you have a deformity of your penis or Peyronie's Disease.
Slovenian: - če imate deformacijo spolnega uda ali Peyroniejevo bolezen;
English: The mean absolute oral bioavailability is 41% (range 25-63%).
Slovenian: Srednja absolutna peroralna biološka uporabnost je 41-% (razpon od 25 do 63 %).
English: In vitro studies:
Slovenian: Raziskave in vitro:
English: Drinking alcohol can temporarily impair your ability to get an erection.
Slovenian: Pitje alkohola lahko začasno ovira zmožnost erekcije.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah po pogostosti so neželeni učinki navedeni po padajoči resnosti.
English: Stevens-Johnson Syndrome (SJS) Toxic Epidermal Necrolysis (TEN)
Slovenian: Stevens-Johnsonov sindrom (SJS),* toksična epidermalna nekroliza (TEN)*
English: Of note, most but not all, of the men who experienced these side effects had heart problems before taking this medicine.
Slovenian: Omeniti je treba, da je večina moških, ne pa vsi, ki so imeli te neželene učinke, imela težave s srcem že pred jemanjem tega zdravila.
English: - Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people)
Slovenian: - Dolgotrajna in včasih boleča erekcija - to se zgodi redko (pojavi se lahko pri največ 1 od 1000 bolnikov)
English: Other medicines and Vizarsin
Slovenian: Druga zdravila in zdravilo Vizarsin
English: Elderly Dosage adjustments are not required in elderly patients (≥ 65 years old).
Slovenian: Starejšim bolnikom odmerka ni treba prilagajati (≥ 65 let).
English: - If you have a severe heart or liver problem.
Slovenian: - Če imate hude težave s srcem ali z jetri.
English: To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking Vizarsin.
Slovenian: Da bo učinek zdravila čim močnejši, vam priporočamo, da ne pijete prevelikih količin alkohola, preden vzamete zdravilo Vizarsin.
English: What you need to know before you take Vizarsin
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Vizarsin
English: - If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Slovenian: - Če imate določene redke dedne očesne bolezni (npr. retinitis pigmentosa).
English: Paediatric population Vizarsin is not indicated for individuals below 18 years of age.
Slovenian: Pediatrična populacija Zdravilo Vizarsin ni indicirano za mlajše od 18 let.
English: This is consistent with ritonavir's marked effects on a broad range of P450 substrates.
Slovenian: To se ujema z izrazitimi učinki ritonavirja na številne substrate P450.
English: The safety profile of sildenafil is based on 9,570 patients in 74 double-blind placebo-controlled clinical studies.
Slovenian: Varnostni profil sildenafila temelji na 9570 bolnikih v 74 dvojno slepih s placebom nadzorovanih kliničnih preizkušanjih.
English: Effects of other medicinal products on sildenafil
Slovenian: Učinki drugih zdravil na sildenafil
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake »EXP«.
English: Dissolve in the mouth.
Slovenian: Raztopite jo v ustih.
English: Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.
Slovenian: Ker imetniku dovoljenja za promet z zdravilom ne poročajo o vseh neželenih učinkih in ker vsi niso zajeti v podatkovni bazi o varnosti, pogostosti neželenih učinkov ne moremo zanesljivo določiti.
English: If Vizarsin does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.
Slovenian: Če vam zdravilo Vizarsin ne pomaga doseči erekcije ali če dosežena erekcija ne traja dovolj dolgo za popoln spolni odnos, morate to povedati zdravniku.