FrancophonIA/ELRC3.0 huggingface dataset:
English: Cresemba 200 mg powder for concentrate for solution for infusion Isavuconazole
Slovenian: Cresemba 200 mg prašek za koncentrat za raztopino za infundiranje izavukonazol
English: CRESEMBA 200 mg powder for concentrate for solution for infusion Isavuconazole
Slovenian: CRESEMBA 200 mg prašek za koncentrat za raztopino za infundiranje izavukonazol
English: QT shortening
Slovenian: Skrajšanje intervala QT
English: Dilution and administration
Slovenian: Redčenje in dajanje
English: Indinavir (CYP3A4/5 strong inhibitor and substrate)
Slovenian: Indinavir (močan inhibitor in substrat CYP3A4/5)
English: Medicinal products metabolised by CYP3A4/5
Slovenian: Zdravila, ki se presnavljajo s CYP3A4/5
English: Uncommon: may affect up to 1 in 100 people - reduced white blood cells - can increase your risk of infection and fever, - reduced blood cells called ‘platelets' - can increase your risk for bleeding or bruising, - reduced red blood cells - can make you feel weak or short of breath or make your skin pale, - severe reduction in blood cells - can make you feel weak, cause bruising or make infections more likely, - rash, swelling of your lips, mouth, tongue or throat with difficulty breathing (hypersensitivity), - low blood sugar levels, - low blood levels of magnesium , - low levels in the blood of a protein called ‘albumin', - not getting the right goodness from your diet (malnutrition), - depression, difficulty sleeping, - seizure, fainting or feeling faint, dizziness,
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov - zmanjšano število levkocitov - lahko poveča tveganje za okužbe in zvišano telesno temperaturo, - zmanjšano število trombocitov - lahko poveča tveganje za krvavenje in modrice, - zmanjšano število eritrocitov - lahko povzroči občutek šibkosti, zasoplost ali bledico, - hudo zmanjšanje števila eritrocitov - povzroči občutek šibkosti, modrice in poveča verjetnost okužb, - izpuščaj, otekanje ustnic, ust, jezika ali žrela s težkim dihanjem (preobčutljivost), - nizka raven sladkorja v krvi, - nizka raven magnezija v krvi, - nizka raven beljakovine albumin v krvi, - zmanjšana absorpcija hranil iz vaše prehrane (nedohranjenost),
English: Dextromethorphan:
Slovenian: Dekstrometorfan:
English: Uncommon: may affect up to 1 in 100 people - reduced white blood cells - can increase your risk of infection and fever, - reduced blood cells called ‘platelets' - can increase your risk for bleeding or bruising, - reduced red blood cells - can make you feel weak or short of breath or make your skin pale, - severe reduction in blood cells - can make you feel weak, cause bruising or make infections more likely, - rash, swelling of your lips, mouth, tongue or throat with difficulty breathing (hypersensitivity), - low blood sugar levels, - low blood levels of magnesium , - low levels in the blood of a protein called ‘albumin', - not getting the right goodness from your diet (malnutrition), - depression, difficulty sleeping, - seizure, fainting or feeling faint, dizziness, - sensation of tingling, tickling, or pricking of the skin (paraesthesia),
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov - zmanjšano število levkocitov - lahko poveča tveganje za okužbe in zvišano telesno temperaturo, - zmanjšano število trombocitov - lahko poveča tveganje za krvavenje in modrice, - zmanjšano število eritrocitov - lahko povzroči občutek šibkosti, zasoplost ali bledico, - hudo zmanjšanje števila eritrocitov - povzroči občutek šibkosti, modrice in poveča verjetnost okužb, - izpuščaj, otekanje ustnic, ust, jezika ali žrela s težkim dihanjem (preobčutljivost), - nizka raven sladkorja v krvi, - nizka raven magnezija v krvi, - nizka raven beljakovine albumin v krvi, - zmanjšana absorpcija hranil iz vaše prehrane (nedohranjenost), - depresija, težave s spanjem, - epileptični krči, omedlevica ali občutek, da boste omedleli, omotica, - občutek mravljinčenja, žgečkanja ali zbadanja v koži (parestezije), - spremenjeno duševno stanje (encefalopatija), - spremembe okusa (dizgevzija), - občutek vrtenja ali vrtoglavica, - težave s srčnim utripom - to je lahko prehitro, neenakomerno ali pa zaznate dodatne srčne utripe; razvidno je na vašem elektrokardiogramu (EKG), - težave s krvnim obtokom, - nizek krvni tlak, - piskajoče dihanje, zelo hitro dihanje, izkašljevanje krvi ali krvavkast izmeček, krvavitve iz nosu, - prebavne motnje, - zaprtje, - občutek napihnjenosti (abdominalna distenzija), - povečana jetra, - vnetje jeter.
English: Indinavir:b) AUCinf: ↓ 36% Cmax: ↓ 52%
Slovenian: AUCinf: ↓ 36 % Cmax: ↓ 52 %
English: (CYP3A4/5 induction)
Slovenian: (indukcija CYP3A4/5)
English: Opioids
Slovenian: Antitusiki
English: Carton for vial for 200 mg powder for concentrate for solution for infusion
Slovenian: Škatla za vialo za 200 mg prašek za koncentrat za raztopino za infundiranje
English: CYP3A4/5 inhibitors
Slovenian: Inhibitorji CYP3A4/5
English: (CYP3A4/5 inhibition)
Slovenian: (inhibicija CYP3A4/5)
English: Omeprazole: no dose adjustment required.
Slovenian: Omeprazol: prilagoditev odmerka ni potrebna.
English: The concomitant administration of CRESEMBA and efavirenz is contraindicated.
Slovenian: Sočasna uporaba zdravila CRESEMBA in efavirenza je kontraindicirana.
English: Vascular disorders
Slovenian: Tromboflebitis^
English: (mild CYP3A4/5 inducer)
Slovenian: (blag induktor CYP3A4/5)
English: ISA 400 mg i.v.
Slovenian: IZA 400 mg, peroralno IZA 400 mg, intravensko
English: Elderly
Slovenian: Antacidi
English: Common Elevated liver chemistry tests^ Uncommon Hepatomegaly; Hepatitis Skin and subcutaneous tissue disorders Common Rash^; Pruritus
Slovenian: Hepatomegalija; hepatitis Bolezni kože in podkožja Pogosti
English: Antigout agent Colchicine (P-gp substrate)
Slovenian: Zdravilo za zdravljenje protina Kolhicin (substrat P-gp)
English: Isavuconazole concentrations may increase.
Slovenian: Koncentracije izavukonazola se lahko povečajo.
English: General disorders and administration site conditions Common Chest pain^; Fatigue; Injection site reaction^ Uncommon Oedema peripheral;^ Malaise; Asthenia
Slovenian: Bolečina v prsnem košu^; utrujenost; reakcija na mestu injiciranja^
English: For example:
Slovenian: Na primer:
English: Do not exceed the recommended dose or duration of treatment.
Slovenian: Ne presezite priporočenega odmerka ali trajanja zdravljenja.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Pristojni organi držav članic bodo morda kasneje, v povezavi z referenčno državo članico, posodobili Informacije o zdravilu, kot je primerno, v skladu s postopki, ki jih določa Poglavje 4, Naslov III Direktive 2001/83/ES.
English: The dosage should be adjusted to the severity of the disorder and the complaints of the patient.
Slovenian: Odmerek je treba prilagoditi stopnji bolezni in bolnikovim težavam.
English: For all ibuprofen-containing products
Slovenian: Za vsa zdravila, ki vsebujejo ibuprofen
English: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
Slovenian: Neželene učinke je mogoče zmanjšati z najkrajšo potrebno uporabo najmanjšega učinkovitega odmerka, ki še zadostuje za nadzor simptomov (glejte poglavje 4.4).
English: Severe heart failure (NYHA Class IV)
Slovenian: Hudo srčno popuščanje (stopnje IV po NYHA)
English: B. Package Leaflet Section 2 - What you need to know before you take [Invented name]
Slovenian: B. Navodilo za uporabo Poglavje 2 - Kaj morate vedeti, preden boste vzeli zdravilo [lastniško ime]
English: These amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are the outcome of the referral procedure.
Slovenian: Te spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so rezultat napotitvenega postopka.
English: Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded.
Slovenian: Čeprav je ekstrapolacija teh podatkov na klinične situacije negotova, ni mogoče izključiti možnosti, da redna, dolgotrajna uporaba ibuprofena lahko zmanjša kardioprotektivne učinke majhnih odmerkov acetilsalicilne kisline.
English: Some other medicines may also affect or be affected by the treatment of [Invented name].
Slovenian: Tudi nekatera druga zdravila lahko vplivajo na zdravljenje z zdravilom [lastniško ime], oziroma zdravilo [lastniško ime] vpliva nanje.
English: - have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Slovenian: - imate povišan krvni tlak, sladkorno bolezen, povišan holesterol, srčno bolezen ali možgansko kap v družinski zdravstveni zgodovini ali če ste kadilec.
English: Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg were taken within 8 h before or within 30 min after immediate release acetylsalicylic acid dosing (81 mg), a decreased effect of acetylsalicylic acid on the formation of thromboxane or platelet aggregation occurred.
Slovenian: Nekatere farmakodinamične študije so pokazale, da se je pri jemanju posameznih odmerkov 400 mg ibuprofena 8 h ali manj pred odmerjanjem acetilsalicilne kisline s takojšnjim sproščanjem (81 mg) ali do 30 min po njem, zmanjšal učinek acetilsalicilne kisline na nastanek tromboksana ali agregacijo trombocitov.
English: You should therefore always seek the advice of your doctor or pharmacist before you use [Invented name] with other medicines.
Slovenian: Zato se morate pred uporabo zdravila [lastniško ime] skupaj z drugimi zdravili vedno posvetovati z zdravnikom ali farmacevtom.
English: Section 4.5 - Interactions with other medicinal products and other forms of interaction [The section should be amended to reflect the following wording (if sub-sections exist this wording should be included in the relevant sub-section, e.g. concomitant use not recommended)]
Slovenian: Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij [To poglavje je treba spremeniti, tako da odraža naslednje besedilo (če obstajajo podpoglavja, je treba besedilo vključiti v ustrezna podpoglavja, npr. besedilo o tem, da sočasna uporaba ni priporočljiva)]
English: - medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
Slovenian: - zdravila, ki znižujejo povišan krvni tlak (zaviralci ACE, kot so kaptopril, antagonisti adrenergičnih receptorjev beta, kot je atenolol, antagonisti receptorjev za angiotenzin-II, kot je losartan)
English: Although there are limited data on the arterial thrombotic risk of dexibuprofen, it is reasonable to assume that the risk with high dose dexibuprofen (1200 mg/day) would be similar to that associated with high dose ibuprofen (2400 mg/day).
Slovenian: Čeprav so podatki o tveganju za arterijske trombotične dogodke zaradi deksibuprofena omejeni, je mogoče utemeljeno predpostaviti, da je tveganje pri velikih odmerkih deksibuprofena (1200 mg/dan) podobno kot tveganje, povezano z velikim odmerkom ibuprofena (2400 mg/dan).
English: Whilst there are no data available for dexibuprofen, it is reasonable to assume that a similar interaction may exist between dexibuprofen (= S(+)-ibuprofen) (which is the pharmacologically active enantiomer of ibuprofen) and low-dose acetylsalicylic acid.
Slovenian: Čeprav podatkov za deksibuprofen ni na voljo, je mogoče utemeljeno predpostaviti, da lahko obstaja podobna interakcija med deksibuprofenom (= S(+)-ibuprofen) (ki je farmakološko učinkoviti enantiomer ibuprofena) in majhnimi odmerki acetilsalicilne kisline.
English: Concomitant administration of dexibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.
Slovenian: Sočasna uporaba deksibuprofena in acetilsalicilne kisline na splošno ni priporočljiva zaradi možnosti povečanja neželenih učinkov.
English: You should discuss your treatment with your doctor or pharmacist before taking [Invented name] if you:
Slovenian: Preden vzamete zdravilo [lastniško ime], se morate o zdravljenju posvetovati z zdravnikom ali farmacevtom, če:
English: For all dexibuprofen-containing products
Slovenian: Za vsa zdravila, ki vsebujejo deksibuprofen
English: Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly.
Slovenian: Eksperimentalni podatki kažejo, da lahko ibuprofen pri sočasni uporabi kompetitivno zavira učinek majhnega odmerka acetilsalicilne kisline na agregacijo trombocitov.
English: Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events.
Slovenian: Epidemiološke študije na splošno ne kažejo, da so majhni odmerki ibuprofena (npr. ≤ 1200 mg/dan) povezani s povečanim tveganjem za arterijske trombotične dogodke.
English: Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.
Slovenian: Sočasna uporaba ibuprofena in acetilsalicilne kisline na splošno ni priporočljiva zaradi možnosti povečanja neželenih učinkov.
English: No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
Slovenian: Pri občasni uporabi ibuprofena ni verjetno, da se bodo pojavili klinično pomembni učinki (glejte poglavje 5.1).
English: - have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke' or transient ischaemic attack “TIA”).
Slovenian: - imate težave s srcem, vključno s srčnim popuščanjem, angino pektoris (bolečine v prsnem košu), ali če ste imeli srčno kap, operacijo srčnega obvoda, periferno arterijsko bolezen (slabo prekrvavitev v nogah ali stopalih zaradi zoženih ali zamašenih arterij), ali kakršno koli obliko možganske kapi (vključno z »malo kapjo« ali tranzitorno ishemično atako, »TIA«),
English: No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).
Slovenian: Pri občasni uporabi ibuprofena ni verjetno, da se bodo pojavili klinično pomembni učinki (glejte poglavje 4.5).
English: Anti-inflammatory/pain-killer medicines like dexibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses.
Slovenian: Zdravila proti vnetju/bolečinam, kot je deksibuprofen, so lahko povezana z majhnim povečanjem tveganja za srčno ali možgansko kap, zlasti pri uporabi velikih odmerkov.
English: - medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
Slovenian: - zdravila proti strjevanju krvi (tj. zdravila za redčenje/preprečevanje strjevanja krvi, npr. acetilsalicilna kislina, varfarin, tiklopidin)
English: Section 4.5 - Interactions with other medicinal products and other forms of interaction [The section should be amended to reflect the following wording]
Slovenian: Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij [To poglavje je treba spremeniti, tako da odraža naslednje besedilo]
English: [Invented name] may affect or be affected by some other medicines.
Slovenian: Zdravilo [lastniško ime] lahko vpliva na druga zdravila ali druga zdravila vplivajo na zdravilo [lastniško ime].
English: Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses.
Slovenian: Zdravila proti vnetju/bolečinam, kot je ibuprofen, so lahko povezana z majhnim povečanjem tveganja za srčno ali možgansko kap, zlasti pri uporabi velikih odmerkov.
English: Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of dexibuprofen (1200 mg/day) are required.
Slovenian: Odločitev je treba temeljito pretehtati tudi pred začetkom dolgotrajnega zdravljenja pri bolnikih z dejavniki tveganja za kardiovaskularne dogodke (npr. hipertenzija, hiperlipidemija, sladkorna bolezen in kajenje), zlasti če so potrebni veliki odmerki deksibuprofena (1.200 mg/dan).
English: Warnings and precautions [The section should be amended to reflect the following wording]
Slovenian: Opozorila in previdnostni ukrepi [To poglavje je treba spremeniti, tako da odraža naslednje besedilo]
English: Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.
Slovenian: Odločitev je treba temeljito pretehtati tudi pred začetkom dolgotrajnega zdravljenja pri bolnikih z dejavniki tveganja za kardiovaskularne dogodke (npr. hipertenzija, hiperlipidemija, sladkorna bolezen in kajenje), zlasti če so potrebni veliki odmerki ibuprofena (2400 mg/dan).
English: Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.
Slovenian: Bolniki z nenadzorovano hipertenzijo, kongestivnim srčnim popuščanjem (razred II-III po NYHA), ugotovljeno ishemično srčno boleznijo, periferno arterijsko boleznijo in/ali cerebrovaskularno boleznijo se smejo zdraviti z ibuprofenom samo po temeljitem premisleku, pri tem pa se je treba izogibati velikim odmerkom (2400 mg/dan).
English: Section 4.8 - Undesirable effects [The section should be amended to reflect the following wording]
Slovenian: Poglavje 4.8 - Neželeni učinki [To poglavje je treba spremeniti, tako da odraža naslednje besedilo]
English: Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with dexibuprofen after careful consideration and high doses (1200 mg/day) should be avoided.
Slovenian: Bolniki z nenadzorovano hipertenzijo, kongestivnim srčnim popuščanjem (razred II-III po NYHA), ugotovljeno ishemično srčno boleznijo, periferno arterijsko boleznijo in/ali cerebrovaskularno boleznijo se smejo zdraviti z deksibuprofenom samo po temeljitem premisleku, pri tem pa se je treba izogibati velikim odmerkom (1.200 mg/dan).
English: You should discuss your treatment with your doctor or pharmacist before taking [Invented name] if you: - have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke' or transient ischaemic attack “TIA”).
Slovenian: Preden vzamete zdravilo [lastniško ime], se morate o zdravljenju posvetovati z zdravnikom ali farmacevtom, če: - imate težave s srcem, vključno s srčnim popuščanjem, angino pektoris (bolečine v prsnem košu), ali če ste imeli srčno kap, operacijo srčnega obvoda, periferno arterijsko bolezen (slabo prekrvavitev v nogah ali stopalih zaradi zoženih ali zamašenih arterij), ali kakršno koli obliko možganske kapi (vključno z »malo kapjo« ali tranzitorno ishemično atako, »TIA«), - imate povišan krvni tlak, sladkorno bolezen, povišan holesterol, srčno bolezen ali možgansko kap v družinski zdravstveni zgodovini ali če ste kadilec.
English: Section 5.1 - Pharmacodynamic properties [The section should be amended to reflect the following wording]
Slovenian: Poglavje 5.1 - Farmakodinamične lastnosti [To poglavje je treba spremeniti, tako da odraža naslednje besedilo]
English: A. Summary of Products Characteristics Section 4.2 - Posology and method of administration [The section should be amended to reflect the following wording]
Slovenian: A. Povzetek glavnih značilnosti zdravila Poglavje 4.2 - Odmerjanje in način uporabe [To poglavje je treba spremeniti, tako da odraža naslednje besedilo]
English: Section 4.4 - Special warnings and precautions for use [The section should be amended to reflect the following wording]
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi [To poglavje je treba spremeniti, tako da odraža naslednje besedilo]
English: Section 4.3 - Contraindications [The section should be amended to reflect the following wording]
Slovenian: Poglavje 4.3 - Kontraindikacije [To poglavje je treba spremeniti, tako da odraža naslednje besedilo]
English: Other medicines and [Invented name] [The section should be amended to reflect the following wording]
Slovenian: Druga zdravila in zdravilo [lastniško ime] [To poglavje je treba spremeniti, tako da odraža naslednje besedilo]
English: Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Slovenian: Klinične študije kažejo, da je lahko uporaba ibuprofena, zlasti pri velikih odmerkih (2400 mg/dan), povezana z majhnim povečanim tveganjem za arterijske trombotične dogodke (na primer miokardnim infarkt ali možgansko kap) (glejte poglavje 4.4).
English: Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Slovenian: Klinične študije kažejo, da je lahko uporaba ibuprofena, zlasti pri velikih odmerkih (2400 mg/dan), povezana z majhnim povečanim tveganjem za arterijske trombotične dogodke (na primer miokardn infarkt ali možgansko kap).
English: Further information on Buvidal can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Buvidal.
Slovenian: Nadaljnje informacije o zdravilu Buvidal so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Buvidal.
English: Buvidal is used in adults and adolescents aged over 16 years who are also receiving medical, social and psychological support.
Slovenian: Uporablja se za odrasle in mladostnike, starejše od 16 let, ki so deležni tudi medicinske, socialne in psihološke podpore.
English: Patients cannot take the medicine home or inject it themselves.
Slovenian: Bolniki zdravila ne smejo nesti domov ali ga injicirati sami.
English: What measures are being taken to ensure the safe and effective use of Buvidal?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Buvidal?
English: This means it can be used in a controlled way to help prevent withdrawal symptoms and reduce the urge to misuse other opioids.
Slovenian: To pomeni, da se ga lahko nadzorovano uporablja za preprečevanje odtegnitvenih simptomov in zmanjševanje potrebe po zlorabi drugih opioidov.
English: Buvidal (buprenorphine)
Slovenian: Buvidal (buprenorfin)
English: An overview of Buvidal and why it is authorised in the EU
Slovenian: Pregled zdravila Buvidal in zakaj je odobreno v EU
English: Although information on the long-term safety of the new formulation was lacking, the Agency's view was that the benefit of Buvidal outweighs the identified risk and it can be authorised for use in the EU.
Slovenian: Čeprav informacij o dolgoročni varnosti nove formulacije ni bilo, je agencija menila, da koristi zdravila Buvidal odtehtajo znana tveganja in se zdravilo lahko odobri za uporabo v EU.