FrancophonIA/ELRC3.0 huggingface dataset:
English: In Study GS-US-380-1490, patients were randomised in a 1:1 ratio to receive either B/F/TAF (n = 320) or dolutegravir + emtricitabine/tenofovir alafenamide (50+200/25 mg) (n = 325) once daily.
Slovenian: B/F/TAF (n = 320) ali dolutegravir + emtricitabin/alafenamidtenofovirat (50 + 200/25 mg) (n = 325) enkrat dnevno.
English: Therefore, caution is recommended when bictegravir is combined with medicinal products known to inhibit P-gp and/or BCRP (e.g. macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir) (see also table below).
Slovenian: makrolidi, ciklosporin, verapamil, dronedaron, glekaprevir/pibrentasvir) (glejte tudi spodnjo preglednico), priporoča previdnost.
English: AUC: ↑ 57%
Slovenian: AUC: ↑ 57 % Cmax: ↑ 28 %
English: Each film-coated tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine, and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Slovenian: 200 mg emtricitabina in alafenamidtenofovirijev fumarat v količini, ki ustreza 25 mg alafenamidtenofovirata.
English:  Do not stop taking Biktarvy if you have hepatitis B. Talk to your doctor first.
Slovenian:  Če imate hepatitis B, ne prenehajte jemati zdravila Biktarvy.
English: ANTI-INFECTIVES Antimycobacterials Rifampicin (600 mg once daily), Bictegravir1 (Induction of CYP3A, UGT1A1, and P-gp)
Slovenian: Zdravila za zdravljenje okužb z mikobakterijami rifampicin (600 mg enkrat dnevno), biktegravir1
English: SPECIAL STORAGE CONDITIONS
Slovenian: PRIPRAVKI RASTLINSKEGA IZVORA
English: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill
Slovenian: IDA Business & Technology Park
English: hyperbilirubinaemia Skin and subcutaneous tissue disorders Uncommon:
Slovenian: desfluoro-hidroksi-BIC-cistein-konjugat, in druge manj pomembne oksidativne presnovke.
English: Gastrointestinal disorders Common:
Slovenian: Znaki osteonekroze so:
English: Co-administration of ciclosporin (IV or oral use) is expected to increase plasma concentrations of both bictegravir and tenofovir alafenamide.
Slovenian: ali peroralna uporaba) povečala koncentracije biktegravirja in alafenamidtenofovirata v plazmi.
English: • anticonvulsants used to treat epilepsy, containing: - carbamazepine, oxcarbazepine, phenobarbital or phenytoin
Slovenian: - karbamazepin, okskarbazepin, fenobarbital ali fenitoin
English: • tiredness (fatigue)
Slovenian: • koprivnica (urtikarija)
English: Hepatitis C virus antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide2
Slovenian: (90 mg/400 mg enkrat dnevno), biktegravir/emtricitabin/ alafenamidtenofovirat2
English: Baseline ATVor DRV-based regimen (n = 287)
Slovenian: Izhodiščni režim na podlagi ATV ali DRV
English: AUC: ↓ 54% Cmax: ↓ 57%
Slovenian: alafenamidtenofovirat: AUC: ↓ 54 % Cmax: ↓ 57 %
English: Antifungals
Slovenian: rifapentin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Karvea on 27 August 1997.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Karvea, veljavno po vsej Evropski uniji, odobrila 27. avgusta 1997.
English: Other information about Karvea
Slovenian: Druge informacije o zdravilu Karvea
English: The full EPAR for Karvea 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 Karvea je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What benefit has Karvea shown during the studies?
Slovenian: Kakšne koristi je zdravilo Karvea izkazalo med študijami?
English: This is a summary of the European public assessment report (EPAR) for Karvea.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Karvea.
English: Karvea was used for two years or more.
Slovenian: Bolniki so zdravilo Karvea jemali dve leti ali več.
English: The usual recommended dose of Karvea is 150 mg once a day.
Slovenian: Običajni priporočeni odmerek zdravila Karvea znaša 150 mg enkrat dnevno.
English: What is the risk associated with Karvea?
Slovenian: Kakšna tveganja so povezana z zdravilom Karvea?
English: For more information about treatment with Karvea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Karvea preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For the treatment of kidney disease, Karvea was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Slovenian: Zdravilo Karvea so glede zdravljenja ledvičnega obolenja preučevali v okviru dveh velikih študij, ki sta vključevali skupno 2 326 bolnikov s sladkorno boleznijo tipa 2.
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 Karvea.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Karvea, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The CHMP decided that Karvea's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Karvea večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: In this study, Karvea was compared with placebo and with amlodipine.
Slovenian: V tej študiji so zdravilo Karvea primerjali s placebom in amlodipinom.
English: The active substance in Karvea, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Zdravilna učinkovina v zdravilu Karvea, irbesartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
English: Karvea is a medicine that contains the active substance irbesartan.
Slovenian: Karvea je zdravilo, ki vsebuje zdravilno učinkovino irbesartan.
English: Karvea is used in adults who have essential hypertension (high blood pressure).
Slovenian: Zdravilo Karvea se uporablja pri odraslih, ki imajo esencialno hipertenzijo (visok krvni tlak).
English: Karvea must not be used in people who are hypersensitive (allergic) to irbesartan or any of the other ingredients.
Slovenian: Zdravila Karvea ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) irbesartan ali katero koli drugo sestavino zdravila.
English: The most common side effect with Karvea (seen in more than 1 patient in 10) is hyperkalaemia (high blood potassium levels).
Slovenian: Najpogostejši neželeni učinek zdravila Karvea (opažen pri več kot 1 bolniku od 10) je hiperkaliemija (visoka raven kalija v krvi).
English: Karvea was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Slovenian: Zdravilo Karvea so pri 712 bolnikih primerjali s placebom (zdravilom brez zdravilne učinkovine), pri 823 bolnikih pa z drugimi zdravili za zdravljenje visokega krvnega tlaka (atenololom, enalaprilom ali amlodipinom).
English: Why has Karvea been approved?
Slovenian: Zakaj je bilo zdravilo Karvea odobreno?
English: Karvea in combination with aliskirencontaining medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Slovenian: Zdravilo Karvea se v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), ne sme uporabljati pri bolnikih s sladkorno boleznijo ali zmerno do hudo ledvično okvaro.
English: For the full list of all side effects reported with Karvea, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Karvea, glejte navodilo za uporabo.
English: In patients with hypertension and type 2 diabetes, Karvea is added to some other treatments for hypertension.
Slovenian: Pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 se zdravilo Karvea dodaja nekaterim drugim zdravilom za zdravljenje visokega krvnega tlaka.
English: In the blood pressure studies, Karvea was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Slovenian: V študijah krvnega tlaka je bilo zdravilo Karvea pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in je imelo podobne učinke kot druga zdravila za zdravljenje visokega krvnega tlaka.
English: In the first kidney disease study, Karvea was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Slovenian: V prvi študiji ledvičnega obolenja je bilo zdravilo Karvea učinkovitejše od placeba pri zmanjševanju tveganja za razvoj poškodbe ledvic, merjene na podlagi izločanja beljakovin.
English: The second study looked at whether Karvea increased the time taken until the patients' blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
Slovenian: V drugi študiji so preučevali, ali zdravilo Karvea podaljša čas, v katerem se raven kreatinina (označevalca ledvičnega obolenja) v krvi bolnikov podvoji, čas do pojava potrebe po presaditvi ledvic ali dializi oziroma čas do nastopa smrti.
English: Karvea is also used to treat kidney disease in adults with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Slovenian: Zdravilo Karvea se uporablja tudi za zdravljenje ledvičnega obolenja pri odraslih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 (sladkorno boleznijo, ki je neodvisna od insulina).
English: Karvea was originally studied in 11 trials for its effects on blood pressure.
Slovenian: Učinke zdravila Karvea na krvni tlak so prvotno preučevali v 11 preskušanjih.
English: In the second kidney disease study, Karvea reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant, or death during the study by 20% in comparison with placebo.
Slovenian: V drugi študiji ledvičnega obolenja je zdravilo Karvea v primerjavi s placebom za 20 % zmanjšalo relativno tveganje za podvojitev ravni kreatinina v krvi, za pojav potrebe po presaditvi ledvic ali za nastop smrti med študijo.
English: What is Karvea used for?
Slovenian: Za kaj se zdravilo Karvea uporablja?
English: How has Karvea been studied?
Slovenian: Kako je bilo zdravilo Karvea raziskano?
English: What is Karvea?
Slovenian: Kaj je zdravilo Karvea?
English: How is Karvea used?
Slovenian: Kako se zdravilo Karvea uporablja?
English: How does Karvea work?
Slovenian: Kako zdravilo Karvea deluje?
English: If you suddenly notice:
Slovenian: Če nenadoma opazite:
English: Study protocol within 2 months after Commission Decision
Slovenian: Protokol študije v 2 mesecih po sklepu Komisije
English: Date of first authorisation: 08/01/2013
Slovenian: Datum prve odobritve: 08/01/2013
English: The applicant should submit yearly interim reports.
Slovenian: Predlagatelj mora predložiti letna vmesna poročila.
English: Availability of resuscitation equipment must be ensured.
Slovenian: Treba je zagotoviti, da je na razpolago oprema za oživljanje.
English: 95% Confidence Interval1
Slovenian: 95-odstotni interval zaupanja
English: There are no data from the use in pregnant women.
Slovenian: Podatkov o uporabi pri nosečnicah ni.
English: Others resolved with supportive treatment with i.v.
Slovenian: Druge so izginile po podpornem zdravljenju z i.v.
English: No overall differences in safety or efficacy were observed between older and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Slovenian: Med starejšimi in mlajšimi bolniki niso opazili splošnih razlik glede varnosti ali učinkovitosti, vendar ni mogoče izključiti večje občutljivosti pri nekaterih starejših posameznikih.
English: This should be considered when the decision is made for a therapy longer than 6 months.
Slovenian: To je treba upoštevati, kadar se odločate o zdravljenju, daljšem od 6 mesecev.
English: Israel
Slovenian: Izrael
English: Special attention is recommended for patients with pre-existing cardiopulmonary disease.
Slovenian: Posebna pozornost se priporoča pri bolnikih z obstoječo kardiopulmonalno boleznijo.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali boste začeli jemati katero koli drugo zdravilo.
English: The potential clinical relevance of these findings is currently unknown; however no adverse effects were associated with the presence of vacuoles.
Slovenian: Morebitni klinični pomen teh ugotovitev trenutno ni znan, vendar so bili neželeni učinki povezani s prisotnostjo vakuol.
English: This medicine will be stored in a healthcare facility where it is administered.
Slovenian: To zdravilo se shranjuje v zdravstveni ustanovi, kjer se uporablja.
English: Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co. Dublin Ireland
Slovenian: Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co. Dublin Irska
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Slovenian: Skupina CMDh se strinja z znanstvenimi zaključki odbora PRAC.
English: Although the 4-week regimen also demonstrated efficacy for the primary endpoint, this regimen was associated with increased frequency of infusion reactions.
Slovenian: Čeprav so pri 4-tedenskem režimu pokazali učinkovitost za primarni opazovani dogodek, je bil ta režim povezan s povečano pogostnostjo reakcij na infundiranje.
English: People with gout have too much uric acid in their body.
Slovenian: Osebe s protinom imajo preveč sečne kisline v telesu.
English: The results of the on-going reproductive toxicity studies are not available (see section 5.3).
Slovenian: Rezultati potekajočih študij reproduktivne toksičnosti niso na voljo (glejte poglavje 5.3).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo.
English: Haemolysis and/or Methemoglobinemia
Slovenian: Hemoliza in/ali methemoglobinemija
English: Instructions for preparation:
Slovenian: Navodila za pripravo:
English: The potency of this product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class.
Slovenian: Jakost tega zdravila se ne sme primerjati z jakostjo drugega pegiliranega ali nepegiliranega proteina iz istega terapevtskega razreda.
English: • Appropriate aseptic technique should be used when preparing the infusion.
Slovenian: • Pri pripravi infuzije je treba uporabiti aseptično tehniko.
English: The optimal treatment duration has not been established (see section 4.4).
Slovenian: Optimalnega trajanja zdravljenja niso določili (glejte poglavje 4.4).
English: The data for long-term treatment from controlled clinical studies are limited.
Slovenian: Podatki o dolgotrajnem zdravljenju iz nadzorovanih kliničnih preskušanj so omejeni.
English: It is unknown whether the development of anti-PEG antibodies may reduce the efficacy of other PEGylated medicinal products.
Slovenian: Ni znano, ali lahko razvoj protiteles proti PEG zmanjša učinkovitost drugih PEGiliranih zdravil.
English: PSURs The PSUR cycle for the medicinal product should follow the standard requirements.
Slovenian: PSUR Cikel PSUR za zdravilo mora slediti standardnim zahtevam.
English: Your doctor may also ask you to wait after your treatment to be sure that you do not have an infusion-related reaction.
Slovenian: Zdravnik vas bo morda prav tako prosil, da počakate po zdravljenju, s čimer se bo prepričal, da nimate reakcije, povezane z infundiranjem.
English: You will receive KRYSTEXXA every 2 weeks.
Slovenian: Zdravilo KRYSTEXXA boste prejeli vsaka 2 tedna.
English: Do not use KRYSTEXXA if you are pregnant or breast-feeding, since it is not known how it will affect you or your baby.
Slovenian: Ne uporabljajte zdravila KRYSTEXXA, če ste noseči ali dojite, saj ni znano, kako bo vplivalo na vas ali vašega otroka.
English: Therefore, KRYSTEXXA should not be used during breast-feeding unless the clear benefit to the mother can overcome the unknown risk to the newborn/infant.
Slovenian: Zato se zdravilo KRYSTEXXA ne sme uporabljati med dojenjem, razen če obstaja jasna korist za mater, ki je večja od neznanega tveganja za novorojenčka/dojenčka.
English: 4.6 Fertility, Pregnancy and Lactation
Slovenian: 4.6 Plodnost, nosečnost in dojenje
English: In addition, a further amendment regarding the extension of the time of observation following the end of infusion from 1 hour to 2 hours as a precautionary measure has been included along with a statement that delayed-type hypersensitivity reactions have also been reported.
Slovenian: Poleg tega je bil vključen dodatni popravek glede podaljšanja časa opazovanja po koncu infundiranja z ene ure na dve uri kot previdnostni ukrep, skupaj z izjavo o poročilih zapoznelih preobčutljivostnih reakcij.
English: • a swelling of the throat, tongue or other part of your body
Slovenian: • otekanje grla, jezika ali drugega dela telesa,
English: From a bacteriological point of view, the product should be used immediately.
Slovenian: Z bakteriološkega stališča je treba zdravilo porabiti takoj.
English: If you have a reaction during the infusion, your doctor may stop or adjust the treatment.
Slovenian: Če imate med infundiranjem reakcijo, bo zdravnik morda prekinil ali prilagodil zdravljenje.
English: Take these medicines as directed by your doctor.
Slovenian: Pri jemanju teh zdravil upoštevajte navodila svojega zdravnika.
English: In the pregnant rat study there was no evidence of embryotoxicity or teratogenicity at 46 times the clinical exposure (AUC).
Slovenian: V študiji na brejih podganah ni bilo dokazov o embriotoksičnosti ali teratogenosti pri 46-kratni klinični izpostavljenosti (AUC).
English: Non-clinical studies to evaluate the carcinogenic and mutagenic potential have not been performed.
Slovenian: Predkliničnih študij za ocenjevanje kancerogenega in mutagenega potenciala niso izvedli.
English: The decision to treat with KRYSTEXXA should be based on an on-going assessment of the benefits and risks for the individual patient (see section 4.4).
Slovenian: Odločitev za zdravljenje z zdravilom KRYSTEXXA mora temeljiti na stalni oceni koristi in tveganj pri posameznem bolniku (glejte poglavje 4.4).
English: The average number of gout flares per patient was 10 during the 18 months prior to study entry.
Slovenian: Povprečno število napadov protina na bolnika je bilo 10 v prvih 18 mesecih pred vključitvijo v študijo.
English: • a rash, itching or hives tell your doctor or nurse IMMEDIATELY, since any of these may be signs of a serious allergic reaction.
Slovenian: • izpuščaj, srbenje ali mehurje, se TAKOJ posvetujte z zdravnikom ali medicinsko sestro, saj so to lahko znaki resne alergijske reakcije.
English: The average molecular mass of pegloticase is approximately 545 kDa of which the protein moiety constitutes approximately 137 kDa.
Slovenian: Povprečna molekulska masa peglotikaze je približno 545 kDa, od katere funkcionalna skupina proteinov predstavlja približno 137 kDa.
English: The long-term risk of prophylactic medications to prevent infusion reactions, such as glucocorticoids, should also be taken into consideration.
Slovenian: Treba je upoštevati dolgoročno tveganje profilaktičnih zdravil za preprečevanje reakcij na infundiranje, kot so glukokortikoidi.
English: The following convention has been used for classification of the adverse reactions reported in the Phase 3 clinical trials (see Table 1 below): 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), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki, o katerih so poročali v kliničnih preskušanjih 3. faze, so bili razvrščeni na naslednji način (glejte spodnjo preglednico 1): zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000); zelo redki (< 1/10.000), neznano (ni mogoče oceniti iz razpoložljivih podatkov).
English: However, due to variability in the AUC values, AUC proportionality was not seen which might be a reflection of antibody clearance for some of the subjects.
Slovenian: Zaradi variabilnosti vrednosti AUC niso opazili sorazmernosti AUC, kar je lahko posledica očistka protiteles pri nekaterih preskušancih.
English: If patients experience treatment-related symptoms affecting their ability to concentrate and react (i.e. headache or dizziness), it is recommended that they do not drive or use machines until the effect subsides.
Slovenian: Če se pri bolnikih pojavijo simptomi, povezani z zdravljenjem, ki vplivajo na zmožnost koncentracije in reakcije (tj. glavobol ali omotica), je priporočljivo, da ne vozijo in ne upravljajo strojev, dokler ti učinki ne izginejo.
English: It is especially important to tell your doctor if you are currently taking other urate-lowering medicines (such as allopurinol or Febuxostat) or medicines containing polyethylene glycol (PEG) (such as pegylated interferon or Doxorubicin).
Slovenian: Še zlasti pomembno je, da zdravnika obvestite, če trenutno jemljete druga zdravila za zniževanje ravni urata (kot je alopurinol ali febuksostat) ali zdravila, ki vsebujejo polietilenglikol (PEG) (kot je pegilirani interferon ali doksorubicin).
English: It is recommended that patients suspected of receiving an overdose be monitored, and general supportive measures be initiated as no specific antidote has been identified.
Slovenian: Priporoča se, da se pri bolnikih, pri katerih obstaja sum, da je prišlo do prevelikega odmerjanja, opravlja spremljanje in uvedejo splošni podporni ukrepi, saj ni posebnega antidota.
English: These medicines may put you at higher risk of infusion reaction.
Slovenian: Ta zdravila vam lahko povečajo tveganje za reakcije na infundiranje.
English: All patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) should be screened for G6PD deficiency before starting KRYSTEXXA.
Slovenian: Pri vseh bolnikih s povečanim tveganjem za pomanjkanje G6PD (npr. bolnikih afriškega ali sredozemskega porekla) je treba opraviti presejanje za pomanjkanje G6PD, preden se uvede zdravilo KRYSTEXXA.
English: Allergic reactions usually happen within 2 hours of the infusion, but may also happen at a later time.
Slovenian: Alergijske reakcije se navadno pojavijo v 2 urah infundiranja, včasih pa tudi pozneje.
English: Patients over 100 kg body weight
Slovenian: Bolniki s telesno maso, večjo od 100 kg
English: The degree of vacuolization and the number of tissues affected appeared to be dependent both on the applied pegloticase dose and the duration of exposure.
Slovenian: Stopnja vakuolizacije in število prizadetih tkiv sta bila odvisna od uporabljenega odmerka peglotikaze in trajanja izpostavljenosti.
English: The recommended dose of KRYSTEXXA is 8 mg.
Slovenian: Priporočeni odmerek zdravila KRYSTEXXA je 8 mg.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravilo se ne sme mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6. 6.3 Rok uporabnosti
English: Pharmacotherapeutic group: Anti-gout preparations, other anti-gout preparations, ATC code: M04AX02
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje protina, druga zdravila za zdravljenje protina, oznaka ATC: M04AX02
English: The solution should be used within 4 hours of dilution (see section 6.6).
Slovenian: Raztopino je treba uporabiti v 4 urah po redčenju (glejte poglavje 6.6).