FrancophonIA/ELRC3.0 huggingface dataset:
English: After chronic dosing of 80 mg three times a day to patients with systemic hypertension the mean change from baseline in systolic and diastolic blood pressure was a decrease of 9.4 mm Hg and 9.1 mm Hg respectively.
Slovenian: Po kroničnem peroralnem odmerjanju 80 mg trikrat na dan pri bolnikih s sistemsko hipertenzijo je bila povprečna sprememba sistoličnega krvnega tlaka v primerjavi z izhodiščem znižanje za 9,4 mmHg, diastoličnega pa znižanje za 9,1 mmHg.
English: Reproductive system and breast disorders Uncommon penile haemorrhage, haematospermia, gynaecomastia
Slovenian: Motnje reprodukcije in dojk občasni neznana krvavitev iz penisa, hemospermija, ginekomastija priapizem, močnejša erekcija
English: Each ml of reconstituted suspension contains 10 mg of sildenafil (as citrate).
Slovenian: 1 ml rekonstituirane suspenzije vsebuje 10 mg sildenafila v obliki sildenafilijevega citrata.
English: The Marketing Authorisation Holder shall agree the Information for healthcare professionals, and the healthcare professionals to be targeted, with the national competent authority of each Member State prior to the launch of the 20 ml vial of Revatio 0.8 mg/ml solution for injection in that country.
Slovenian: Pred prihodom 20 ml viale zdravila Revatio 0,8 ml/mg raztopina za injiciranje na trg v vsaki državi članici, mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom uskladiti informacije za zdravstvene delavce in ciljne skupine.
English: One 20 ml vial contains 10 mg of sildenafil (as citrate).
Slovenian: Ena 20 ml viala vsebuje 10 mg sildenafila v obliki sildenafilijevega citrata.
English: Placebo corrected increases in 6MWD were 45 metres (p < 0.0001), 46 metres (p < 0.0001) and 50 metres (p < 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively.
Slovenian: Za placebo korigirano povečanje 6MWD je bilo za 20 mg sildenafila trikrat na dan 45 metrov (p < 0,0001), za 40 mg trikrat na dan 46 metrov (p < 0,0001) in za 80 mg trikrat na dan 50
English: The following serious adverse events have been reported commonly (may affect up to 1 in 10 people); pneumonia, heart failure, right heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities.
Slovenian: visok krvni tlak v pljučih, bolečina v prsnem košu, omedlevica, okužba dihal, bronhitis, virusna okužba v želodcu in prebavilih, okužba sečil in zobna gniloba.
English: A greater percentage of patients on each of the sildenafil doses (i.e. 28 %, 36 % and 42 % of subjects who received sildenafil 20 mg, 40 mg and 80 mg TID doses, respectively) showed an improvement by at least one WHO functional class at week 12 compared to placebo (7 %).
Slovenian: Po 12 tednih je v primerjavi s placebom (7 %) v vseh skupinah s sildenafilom večji odstotek bolnikov kazal izboljšanje vsaj enega funkcijskega razreda po SZO (28 % za bolnike, ki so prejemali 20 mg trikrat na dan; 36 % za bolnike, ki so prejemali 40 mg trikrat na dan in 42 % za bolnike, ki so prejemali 80 mg trikrat na dan).
English: Effects of other medicinal products on intravenous sildenafil Predictions based on a pharmacokinetic model suggest that drug-drug interactions with CYP3A4 inhibitors should be less than observed after oral sildenafil administration.
Slovenian: Po napovedih farmakokinetičnega modela bi morala biti medsebojna delovanja z zaviralci CYP3A4 manjša kot po peroralni uporabi sildenafila.
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with oral sildenafil (100 mg single dose) resulted in a 140 % increase in sildenafil Cmax and a 210 % increase in sildenafil AUC.
Slovenian: Sočasna uporaba zaviralca proteaze HIV sakvinavirja, ki zavira CYP3A4, v stanju dinamičnega ravnovesja (1.200 mg trikrat na dan) in peroralnega sildenafila (posamičen odmerek 100 mg) je povzročila 140 % povečanje Cmax sildenafila in 210 % povečanje AUC sildenafila.
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140 % increase in sildenafil Cmax and a 210 % increase in sildenafil AUC.
Slovenian: Sočasna uporaba zaviralca proteaze HIV sakvinavirja, ki zavira CYP3A4, v stanju dinamičnega ravnovesja (1.200 mg trikrat na dan) in sildenafila (posamičen odmerek 100 mg) je povzročila 140 % povečanje Cmax sildenafila in 210 % povečanje AUC sildenafila.
English: Titanium dioxide (E171) Sodium benzoate (E211) Silica, colloidal anhydrous
Slovenian: Prašek za peroralno suspenzijo: sorbitol brezvodna citronska kislina sukraloza natrijev citrat ksantanski gumi titanov dioksid (E171) natrijev benzoat (E211) brezvodni koloidni silicijev dioksid
English: Warnings and precautions Talk to your doctor before taking Revatio if you: - have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
Slovenian: - imate bolezen zaradi zamašene ali zožene vene v pljučih, ne pa zaradi zamašene ali zožene arterije.
English: Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with oral sildenafil (100 mg single dose) resulted in a 300 % (4-fold) increase in sildenafil Cmax and a 1,000 % (11-fold) increase in sildenafil plasma AUC.
Slovenian: Sočasna uporaba zaviralca proteaze HIV ritonavirja (zelo močan zaviralec P450) v stanju dinamičnega ravnovesja (500 mg dvakrat na dan) in peroralnega sildenafila (posamičen odmerek 100 mg) je povzročila 300 %, tj. 4-kratno, povečanje Cmax sildenafila in 1.000 %, tj. 11-kratno, povečanje AUC sildenafila v plazmi.
English: Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300 % (4-fold) increase in sildenafil Cmax and a 1,000 % (11-fold) increase in sildenafil plasma AUC.
Slovenian: Sočasna uporaba zaviralca proteaze HIV ritonavirja (zelo močan zaviralec P450) v stanju dinamičnega ravnovesja (500 mg dvakrat na dan) in sildenafila (posamičen odmerek 100 mg) je povzročila 300 %, tj. 4-kratno, povečanje Cmax sildenafila in 1.000 %, tj. 11-kratno, povečanje AUC sildenafila v plazmi.
English: (p<0.0001) for sildenafil 20 mg, 40 mg and
Slovenian: 5 (p = 0,0051), za 40 mg trikrat na dan
English: What Revatio contains - The active substance is sildenafil (as sildenafil citrate).
Slovenian: - Učinkovina je sildenafil v obliki sildenafilijevega citrata.
English: Vascular disorders Very common flushing
Slovenian: Žilne bolezni zelo pogosti zardevanje neznana hipotenzija
English: Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity.
Slovenian: Zdravljenje odraslih bolnikov s pljučno arterijsko hipertenzijo v II.
English: Patients enrolled into the pivotal oral route study were eligible to enter a long term open label extension study.
Slovenian: Podatki o dolgoročnem preživetju pri populaciji, ki še ni prejemala zdravljenja Bolniki, vključeni v ključno študijo po peroralni poti, so bili primerni za dolgoročno odprto podaljšano študijo.
English: Recent history of stroke or myocardial infarction, Severe hypotension (blood pressure < 90/50 mmHg) at initiation.
Slovenian: Ker varnost sildenafila ni raziskana v naslednjih podskupinah bolnikov, je uporaba sildenafila pri leteh kontraindicirana: - s hudo okvaro jeter, - z anamnezo o nedavni možganski kapi ali miokardnem infarktu, - s hudo hipotenzijo (krvni tlak < 90/50 mmHg) ob uvedbi.
English: In volunteers with severe renal impairment (creatinine clearance < 30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100 % and 88 % respectively compared to age-matched volunteers with no renal impairment.
Slovenian: Zaradi tega se je v primerjavi s prostovoljci brez okvare ledvic enake starosti AUC povečala za 100 % in Cmax za 88 %.
English: Revatio (oral) is indicated for treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity.
Slovenian: Peroralna oblika zdravila Revatio je namenjena za zdravljenje odraslih bolnikov s pljučno arterijsko hipertenzijo v II.
English: Each ml of the reconstituted suspension contains 10 mg of sildenafil (as citrate).
Slovenian: Po rekonstituciji 1 ml suspenzije vsebuje 10 mg sildenafila v obliki sildenafilijevega citrata.
English: Patients enrolled into the pivotal study were eligible to enter a long term open label extension study.
Slovenian: Podatki o dolgoročnem preživetju pri populaciji, ki še ni prejemala zdravljenja Bolniki, vključeni v ključno študijo, so bili primerni za dolgoročno odprto podaljšano študijo.
English: Hypromellose Titanium dioxide (E171) Lactose monohydrate Glycerol triacetate
Slovenian: laktoza monohidrat triacetin
English: Replace the cap on the bottle, leaving the bottle adaptor in place.
Slovenian: Nastavek pustite v steklenici in jo zaprite z zaporko.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: raztopina za injiciranje bistra, brezbarvna raztopina
English: Film-coated tablet.
Slovenian: sildenafila v plazmi.
English: Therefore, doses higher than the recommended doses should not be used in paediatric patients with PAH (see also sections 4.2 and
Slovenian: Pri pediatričnih bolnikih s PAH se ne sme uporabljati odmerkov, večjih od priporočenih (glejte tudi poglavji 4.4 in
English: Turn the bottle upside down while holding the oral dosing syringe in place.
Slovenian: Medtem, ko držite peroralno odmerno brizgo na mestu, obrnite steklenico na glavo.
English: Eye disorders Common retinal haemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia
Slovenian: Očesne bolezni pogosti mrežnična krvavitev, okvara vida, zamegljen vid, fotofobija, kromatopsija, cianopsija, draženje oči, očesna hiperemija občasni neznana zmanjšanje ostrine vida, diplopija, nenormalni občutki v očesu nearteritična anteriorna ishemična optična nevropatija (NAION)*, zapora mrežnične vene*, izpad vidnega polja*
English: Treatment group
Slovenian: Skupina z določenim načinom zdravljenja
English: The European Commission issued a decision on 25 September 2017.
Slovenian: Evropska komisija je sklep izdala 25. septembra 2017.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/116)
Slovenian: Izid napotitvenega postopka v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/116)
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25 September 2017
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25.
English: What is moxidectin?
Slovenian: Kaj je moksidektin?
English: These included data from companies and from the published literature.
Slovenian: Vključeni so bili podatki, ki so jih priskrbele družbe, in podatki iz objavljene literature.
English: Why were veterinary medicines containing moxidectin reviewed?
Slovenian: Zakaj so bila zdravila za uporabo v veterinarski medicini, ki vsebujejo moksidektin, pregledana?
English: The sampling will help generate further data to assess the environmental exposure of moxidectin and will be a condition for maintaining the marketing authorisations of these veterinary medicines in the EU.
Slovenian: Vzorčenje bo v pomoč pri pridobivanju nadaljnjih podatkov za ocenjevanje izpostavljenosti okolja moksidektinu in bo pogoj za ohranitev dovoljenj za promet s temi zdravili za uporabo v veterinarski medicini v EU.
English: The CVMP reviewed available data on PBT properties of moxidectin.
Slovenian: Odbor CVMP je pregledal razpoložljive podatke o lastnostih PBT moksidektina.
English: Questions and answers on the environmental impact of moxidectin-containing veterinary medicines used in cattle, sheep and horses EMA/587529/2017
Slovenian: Vprašanja in odgovori o vplivu zdravil za uporabo v veterinarski medicini, ki vsebujejo moksidektin, pri govedu, ovcah in konjih na okolje EMA/587529/2017
English: The CVMP also noted that veterinary medicines containing moxidectin are an effective and important therapeutic option for treating internal and external parasites in cattle, sheep and horses.
Slovenian: Opozoril je tudi, da so zdravila za uporabo v veterinarski medicini, ki vsebujejo moksidektin, učinkovita in pomembna terapevtska možnost za zdravljenje notranjih in zunanjih parazitov pri govedu, ovcah in konjih.
English: In order to minimise the identified environmental risks, the CVMP recommended risk mitigation measures and warnings, to be included in the product information, including a precaution that treatment should only be given when necessary and should be based on faecal counts or an evaluation risk of infestation at the animal or herd level.
Slovenian: Da bi zmanjšali ugotovljena tveganja za okolje, je odbor CVMP priporočil ukrepe za zmanjšanje tveganja in opozorila, ki jih je treba vključiti v informacije o zdravilu, vključno s previdnostnim ukrepom, da je treba zdravilo dajati le, kadar je nujno potrebno, in na podlagi števila parazitov v blatu ali oceni tveganja za infestacijo na ravni živali ali črede.
English: The CVMP recommended obtaining samples from relevant environmental compartments after use of the 5 mg/ml pour-on solution or 100 mg/ml injectable solution in beef cattle on pasture.
Slovenian: Priporočil je odvzem vzorcev iz ustreznih ekosistemov po uporabi raztopine za kožni poliv v odmerku 5 mg/ml ali raztopine za injiciranje v odmerku 100 mg/ml pri pitanem govedu na pašniku.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that these medicines might have a longterm impact on the environment due to their persistent, bioaccumulative and toxic (PBT) properties.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da bi lahko ta zdravila zaradi svoje obstojnosti, sposobnosti kopičenja v organizmu in strupenosti (PBT) imela dolgoročen vpliv na okolje.
English: Based on the evaluation of the currently-available data from laboratory studies, the CVMP concluded that moxidectin fulfils the criteria to be considered a PBT substance, and that its use poses a risk to the environment.
Slovenian: Na podlagi ovrednotenja trenutno razpoložljivih podatkov iz laboratorijskih študij je odbor CVMP zaključil, da moksidektin izpolnjuje merila za uvrstitev med snovi PBT in da njegova uporaba pomeni tveganje za okolje.
English: Moxidectin is a broad-spectrum antiparasitic medicine widely used to treat and prevent parasitic infections (such as roundworms, fluke and lice) in both food-producing and companion animals.
Slovenian: Moksidektin je širokospektralni antiparazitik, ki se pogosto uporablja za zdravljenje in preprečevanje parazitskih infestacij (kot so gliste, metljaji in uši) pri živalih, namenjenih za proizvodnjo živil in hišnih živalih.
English: The CVMP was requested to consider whether moxidectin meets the criteria to be classified as a PBT substance and, if necessary, to provide recommendations on appropriate measures to prevent environmental exposure.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je bil zaprošen, naj prouči, ali moksidektin izpolnjuje merila za uvrstitev med snovi PBT, in po potrebi izda priporočila o ustreznih ukrepih za preprečevanje izpostavljenosti okolja.
English: On 22 October 2015, the German competent authority triggered a review of veterinary medicines containing moxidectin because of concerns that moxidectin may have PBT properties and could therefore pose a serious risk to the environment.
Slovenian: Nemški pristojni organ je 22. oktobra 2015 sprožil pregled zdravil za uporabo v veterinarski medicini, ki vsebujejo moksidektin, in sicer zaradi pomislekov, da je moksidektin obstojen, se kopiči v organizmu in je strupen ter tako pomeni resno tveganje za okolje.
English: Questions and answers on the environmental impact of moxidectin-containing veterinary medicines used in cattle, sheep and horses
Slovenian: Vprašanja in odgovori o vplivu zdravil za uporabo v veterinarski medicini, ki vsebujejo moksidektin, pri govedu, ovcah in konjih na okolje
English: The CVMP also concluded that the marketing authorisation holders should investigate whether, under relevant environmental conditions of use, moxidectin is detected in the local environment.
Slovenian: Poleg tega je zaključil, da morajo imetniki dovoljenj za promet z zdravilom proučiti, ali je v ustreznih okoljskih pogojih uporabe mogoče moksidektin zaznati v lokalnem okolju.
English: On 11 May 2017, the European Medicines Agency completed a review of oral, topical and injectable moxidectin-containing veterinary medicines used in cattle, sheep and horses.
Slovenian: Evropska agencija za zdravila je 11. maja 2017 zaključila pregled peroralnih in topikalnih zdravil za uporabo v veterinarski medicini ter zdravil za uporabo v veterinarski medicini v obliki injekcije, ki vsebujejo moksidektin, za uporabo pri govedu, ovcah in konjih.
English: Consequently, the CVMP recommended measures to mitigate against the environmental risks, as well as warnings, to be included within the product information.
Slovenian: Zato je priporočil ukrepe za zmanjšanje tveganj za okolje in opozorila, ki jih je treba vključiti v informacije o zdravilu.
English: In addition, a condition was placed on the marketing authorisations with the purpose of obtaining field data to determine whether, under actual conditions of use and relevant environmental conditions, the hazards due to the PBT properties of these products can be prevented.
Slovenian: Poleg tega je bil v dovoljenja za promet z zdravilom dodan pogoj za pridobitev terenskih podatkov, s čimer bi ugotovili, ali je mogoče preprečiti nevarnosti teh zdravil zaradi njihove obstojnosti, sposobnosti kopičenja v organizmu in strupenosti v dejanskih pogojih uporabe in ustreznih okoljskih pogojih.
English: You may also feel confused, particularly if you are elderly.
Slovenian: Morda boste tudi zmedeni, še zlasti če ste starejši.
English: The volume of distribution is approximately 1 l/kg.
Slovenian: Volumen porazdelitve je približno 1 l/kg.
English: This medicine should not be given to children (i.e. anyone below the age of 18 years).
Slovenian: Ne dajajte tega zdravila otrokom (tj. mlajšim od 18 let).
English: − Having trouble sleeping;
Slovenian: − težave s spanjem;
English: This is especially important if you feel depressed or might be thinking about suicide.
Slovenian: To je še posebno pomembno, če ste depresivni ali če razmišljate o samomoru.
English: Symptoms typically emerge within a few days or weeks of starting the treatment.
Slovenian: Simptomi se običajno pojavijo v nekaj dneh ali tednih po začetku zdravljenja.
English: The recommended dose is one tablet each time.
Slovenian: Priporočeni odmerek je vsakič ena tableta.
English: Not known: frequency cannot be estimated from the available data
Slovenian: Neznana pogostnost: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov:
English: Your doctor will monitor you more closely.
Slovenian: Zdravnik vas bo podrobneje spremljal.
English: All were reported to be Grade 3 or 4.
Slovenian: Vsi primeri so bili 3. ali 4. stopnje.
English: Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
Slovenian: Zdravnik se bo z vami pogovoril o njih in vam pojasnil možna tveganja in koristi zdravljenja.
English: If this is not the case, local or international treatment protocols and guidelines should be followed.
Slovenian: Če teh navodil ni, je treba upoštevati lokalne ali mednarodne protokole in smernice za zdravljenje.
English: Vaccinations with inactivated vaccines are usually possible.
Slovenian: Cepljenja z inaktiviranimi cepivi so običajno dopustna.
English: If you stop taking this medicine too quickly, you may have low blood pressure.
Slovenian: Če prehitro prenehate jemati to zdravilo, se lahko pojavi nizek krvni tlak.
English: Risk of infection
Slovenian: Tveganje za okužbe
English: The efficacy of midazolam may be reduced.
Slovenian: Učinkovitost midazolama se lahko zmanjša;
English: You must take this medicine on the appropriate days, exactly as your doctor prescribed.
Slovenian: Zdravilo morate jemati na ustrezne dneve, natančno tako, kot vam je predpisal zdravnik.
English: FN was reported to be serious in 4.0% of patients.
Slovenian: O resni FN so poročali pri 4,0 % bolnikov.
English: No antidote exists and treatment is symptomatic.
Slovenian: Antidota ni, zdravljenje pa je simptomatsko.
English: − Frequent urination;
Slovenian: − pogosto uriniranje;
English: Uncontrolled psychoses.
Slovenian: Nenadzorovane psihoze.
English: Other possible side effects may be:
Slovenian: Drugi možni neželeni učinki so:
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000 including isolated reports), not known (cannot be estimated from the available data).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000, vključujoč posamezne primere), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Sodium intake should be reduced and blood pressure should be monitored.
Slovenian: Zato je treba zmanjšati vnos natrija in spremljati krvni tlak.
English: In order to minimise insomnia, the tablet should preferably be taken in the morning.
Slovenian: Da se zmanjša tveganje za nespečnost, je tableto najbolje vzeti zjutraj.
English: If you are over 65 years old and/or frail, your doctor may prescribe a half tablet each time.
Slovenian: Če ste starejši od 65 let in/ali slabotni, vam lahko zdravnik predpiše polovico tablete.
English: − Infection, inflammation of the whole body due to infection (sepsis);
Slovenian: − okužba, vnetje celega telesa zaradi okužbe (sepsa);
English: Your doctor will arrange appropriate blood tests before and during treatment.
Slovenian: Vaš zdravnik bo pred zdravljenjem in med njim naročil ustrezne krvne preiskave.
English: The treatments with the two medicinal products should be separated by at least one week.
Slovenian: Med uporabo teh dveh zdravil mora preteči najmanj en teden.
English: You and your partner must use appropriate contraception.
Slovenian: S partnerjem morata uporabljati ustrezno kontracepcijo.
English: − if you have an untreated psychiatric illness.
Slovenian: − če imate nezdravljeno duševno bolezen.
English: 17, Parc des Vautes 34980 Saint Gély du Fesc France
Slovenian: 17, Parc des Vautes 34980 Saint Gély du Fesc Francija
English: This should be taken into consideration in the surveillance of the patient.
Slovenian: To lastnost je treba upoštevati pri spremljanju bolnikov.
English: Before the start of treatment, any source of infection, especially tuberculosis, should be removed.
Slovenian: Pred začetkom zdravljenja je treba odpraviti vsa morebitna žarišča okužb, zlasti tuberkuloze.
English: Efficacy of hormone replacement therapy may also be reduced.
Slovenian: Zmanjša se lahko tudi učinkovitost hormonskega nadomestnega zdravljenja;
English: Specific groups of patients
Slovenian: Posebne skupine bolnikov
English: Your doctor will decide the dose and tell you on which days you should take it.
Slovenian: Zdravnik bo določil, kakšen odmerek in katere dneve ga boste jemali.
English: Effective measures to avoid pregnancy must be taken (see section 4.6).
Slovenian: Sprejeti je treba učinkovite ukrepe za preprečitev nosečnosti (glejte poglavje 4.6).
English: Do not use this medicine if you notice any defects, or any signs of deterioration of the tablets or packaging.
Slovenian: Ne uporabljajte tega zdravila, če opazite kakršno koli pomanjkljivost ali znake poslabšanja stanja tablet ali ovojnine.
English: No chronic toxicity and carcinogenicity data are available.
Slovenian: Podatki o kronični toksičnosti in rakotvornosti niso na voljo.