FrancophonIA/ELRC3.0 huggingface dataset:
English: At steady-state, the relative bioavailability of doxazosin from prolonged-release tablets compared to that of immediate release form was 54% at the 4 mg dose and 59% at the 8 mg dose.
Slovenian: V stanju dinamičnega ravnovesja je pri odmerku 4 mg relativna biološka uporabnost doksazosina v tabletah s podaljšanim sproščanjem 54 % relativne biološke uporabnosti doksazosina v tabletah s takojšnjim sproščanjem, pri odmerku 8 mg pa 59 %.
English: Data from these studies indicate that patients well controlled on immediate release tablets of doxazosin in doses of 1 mg, 2 mg or 4 mg are equally controlled on doxazosin 4 mg prolonged-release tablets.
Slovenian: Podatki iz teh študij so pokazali, da je nadzor bolezni pri bolnikih, ki prejemajo odmerke 1 mg, 2 mg ali 4 mg v obliki tablet s takojšnjim sproščanjem, enak kot pri bolnikih, ki prejemajo 4-miligramske tablete doksazosina s podaljšanim sproščanjem.
English: Doxastad 4 mg prolonged release tablets and associated names works by relaxing muscle around the bladder exit and prostate gland, making it easier to pass urine.
Slovenian: Zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena deluje tako, da sprošča mišice okoli izvodila mehurja in prostate, kar olajša uriniranje.
English: Polyethylene oxide Microcrystalline cellulose Povidone
Slovenian: Polietilenoksid Celuloza, mikrokristalna Povidon dl-α-tokoferol
English: Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, muscle cramps.
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva: mialgija, artralgija, mišični krči.
English: Symptomatic treatment of benign prostatic hyperplasia.
Slovenian: Simptomatsko zdravljenje benigne hiperplazije prostate.
English: Peak/trough ratio of doxazosin prolonged-release tablets is less than half that of immediate release doxazosin tablets.
Slovenian: Razmerje najvišjih koncentracij in koncentracij pred naslednjim odmerkom pri tabletah doksazosina s podaljšanim sproščanjem je manjše kot polovica razmerja pri tabletah doksazosina s takojšnjim sproščanjem.
English: Further information
Slovenian: DRUGI PODATKI
English: 7 MARKETING AUTHORISATION HOLDER [To be completed nationally]
Slovenian: 7 IMETNIK DOVOLJENJA ZA PROMET [Izpolni država članica]
English: Patients with hepatic impairment:
Slovenian: Bolniki z jetrno okvaro:
English: Do not take Doxastad 4 mg prolonged release tablets and associated names if you are pregnant or breast-feeding.
Slovenian: Zdravila Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena ne jemljite, če ste noseči ali če dojite.
English: Speak to your doctor first.
Slovenian: Preden ga vzamete, se posvetujte z zdravnikom.
English: Respiratory, thoracic and mediastinal disorders: Dyspnoea, cough, bronchial spasms, epistaxis.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora: dispneja, kašelj, spazem bronhusov, epistaksa.
English: Benign Prostatic hyperplasia:
Slovenian: Benigna hiperplazija prostate:
English: Prolonged-release tablet
Slovenian: Tableta s podaljšanim sproščanjem
English: Do not use Doxastad 4 mg prolonged release tablets and associated names after the expiry date which is stated on the carton.
Slovenian: Zdravila Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: Habituation has not been observed during long-term treatment with doxazosin immediate release tablets.
Slovenian: Pri dolgotrajnem zdravljenju s tabletami doksazosina s takojšnjim sproščanjem niso opazili habituacije.
English: General disorders and administration site conditions: Chest pain, agitation, facial flushing.
Slovenian: Splošne težave in spremembe na mestu aplikacije: bolečine v prsnem košu, agitacija, zardevanje obraza.
English: High levels of alpha-1-adrenoreceptors have been observed in the prostatic muscular stroma, the proximal part of the urethra and base of the urinary bladder, which medicates smooth muscle tonus in the prostatic part of the urethra.
Slovenian: V mišični stromi prostate, proksimalnem delu uretre, ki uravnava tonus gladkih mišic v prostatičnem delu uretre, so opazili visoke koncentracije alfa-1 adrenoreceptorjev.
English: [To be completed on finalisation of the procedure]
Slovenian: [Izpolni država članica]
English: GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: PODLAGA ZA DOPOLNILO POVZETKA(OV) GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
English: Rare cases of syncope in association with orthostatic hypotension have been observed.
Slovenian: V povezavi z ortostatsko hipertenzijo so opazili redke primere sinkope.
English: Doxastad 4 mg prolonged release tablets and associated names can be taken with or without food.
Slovenian: Zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena se lahko jemlje s hrano ali brez nje.
English: Symptomatic treatment of Benign prostatic hyperplasia:
Slovenian: Simptomatsko zdravljenje benigne hiperplazije prostate:
English: The following adverse events have been reported in clinical use of immediate release tablets of doxazosin:
Slovenian: V klinični uporabi tablet doksazosina s takojšnjim sproščanjem so poročali o naslednjih neželenih učinkih:
English: Doxazosin may be used in benign prostatic hyperplasia patients who are either hypertensive or normotensive, as the blood pressure reduction in normotensive patients is generally slight.
Slovenian: Znižanje krvnega tlaka pri normotenzivnih bolnikih je na splošno majhno, zato se lahko doksazosin uporablja pri hipertenzivnih in tudi pri normotenzivnih bolnikih z benigno hiperplazijo prostate.
English: • if you have benign prostatic hyperplasia and concomitant congestion of the upper urinary tract,
Slovenian: • če imate benigno hiperplazijo prostate in sočasni zastoj zgornjih sečil, kronično vnetje sečil ali kamne v mehurju;
English: Doxazosin has been shown to inhibit phenylephrine induced contraction in the prostate.
Slovenian: Pokazali so, da doksazosin zavira krčenje prostate, ki ga sproža fenilefrin.
English: Doxastad 4 mg prolonged release tablets and associated names should therefore not be administered to breastfeeding women.
Slovenian: Zato se zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena doječim ženskam ne sme dajati.
English: You must keep taking your Doxastad 4 mg prolonged release tablets and associated names as instructed by your doctor.
Slovenian: Zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena morate jemati po zdravnikovih navodilih.
English: Doxastad 4 mg prolonged release tablets and associated names [See Annex I] Doxazosin
Slovenian: Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena [glejte Dodatek I] doksazosin
English: The following undesirable effects have been reported in controlled clinical trials with doxaszosin prolonged-release tablets.
Slovenian: V nadzorovanih kliničnih preskušanjih s tabletami doksazosina s podaljšanim sproščanjem so poročali o naslednjih neželenih učinkih.
English: The doxazosin arm of ALLHAT was discontinued as a result of these findings.
Slovenian: Zaradi teh ugotovitev so prekinili vejo študije ALLHAT, v kateri so bolniki prejemali doksazosin.
English: What Doxastad 4 mg prolonged release tablets and associated names contains - The active substance is doxazosin (as mesilate).
Slovenian: Kaj vsebuje zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena - Zdravilna učinkovina je doksazosin (v obliki mesilata).
English: the CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxastad 4 mg prolonged release tablets and associated names (see Annex I).
Slovenian: je CHMP za Doxastad 4 mg tablete s podaljšanim sproščanjem in z njim povezana imena (glejte Dodatek I) priporočil odobritev dovoljenj za promet, za katera so Povzetki glavnih značilnosti zdravila, označevanje in Navodila za uporabo opredeljeni v Dodatku III.
English: Syncope occurred in a fasting adult who had taken doxazosin 16 mg. A 13-year-old experienced moderate intoxication following a maximum dose of doxazosin 40 mg.
Slovenian: Pri 13-letnem bolniku je po največjem odmerku 40 mg doksazosina prišlo do zmerne intoksikacije.
English: Each prolonged-release tablet contains 4 mg of doxazosin (as mesilate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta s podaljšanim sproščanjem vsebuje 4 mg doksazosina (v obliki mesilata).
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Peroralna uporaba.
English: If you take more Doxastad 4 mg prolonged release tablets and associated names than you should
Slovenian: Če ste vzeli večji odmerek zdravila Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena, kot bi smeli.
English: Oral
Slovenian: Peroralno
English: DOXAZOSINA NEO STADA 4 mg comprimidos de
Slovenian: DOXAZOSINA NEO STADA 4 mg comprimidos de liberación prolongada EEG
English: Hepatobiliary disorders: Icterus, increased liver transaminases.
Slovenian: Bolezni jeter, žolčnika in žolčevodov: ikterus, zvišane vrednosti jetrnih transaminaz.
English: Doxazosin should be administered with caution in patients with signs of minor to moderate hepatic impairment.
Slovenian: Pri bolnikih z manjšo do zmerno jetrno okvaro je treba doksazosin odmerjati previdno.
English: 10 DATE OF REVISION OF THE TEXT [To be completed nationally]
Slovenian: 10 DATUM ZADNJE REVIZIJE BESEDILA
English: Take special care with Doxastad 4 mg prolonged release tablets and associated names
Slovenian: Bodite posebno pozorni pri jemanju zdravila Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena:
English: Cmin is unaffected by concomitant food intake.
Slovenian: Sočasno uživanje hrane na vrednost Cmin ne vpliva.
English: Metabolism and nutrition disorders: Gout.
Slovenian: Presnovne in prehranske motnje: protin.
English: Doxazosin potentiates the blood pressure lowering effect of other antihypertensives.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Doksazosin okrepi učinek drugih antihipertenzivov na nižanje krvnega tlaka.
English: Do not take Doxastad 4 mg prolonged release tablets and associated names
Slovenian: Ne jemljite zdravila Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena:
English: Marketing Authorisation Holder
Slovenian: Imetnik dovoljenja za promet z zdravilom Vlagatelj
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Doxastad 4 mg prolonged release tablets and associated names [See Annex I] (Doxazosin)
Slovenian: NAVODILO ZA UPORABO Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena [glejte Dodatek I] (doksazosin)
English: No special requirements.
Slovenian: Navedba smiselno ni potrebna.
English: 3 HOW TO TAKE DOXASTAD 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES
Slovenian: 13 KAKO JEMATI ZDRAVILO DOXASTAD 4 MG TABLETE S PODALJŠANIM SPROŠČANJEM IN POVEZANA IMENA
English: Taking Doxastad 4 mg prolonged release tablets and associated names with food and drink Doxastad 4 mg prolonged release tablets and associated names can be taken with or after food.
Slovenian: Zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena se lahko jemlje s hrano ali po njej.
English: What Doxastad 4 mg prolonged release tablets and associated names looks like and contents of the pack
Slovenian: Izgled zdravila Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena in vsebina pakiranja
English: 1 WHAT DOXASTAD 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES IS AND WHAT IT IS USED FOR
Slovenian: Kaj je zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena in za kaj ga uporabljamo
English: Interruption of breast-feed should be considered in cases of required continuation of doxazosin.
Slovenian: Kadar je nadaljevanje zdravljenja z doksazosinom nujno, bo morda treba prekiniti dojenje.
English: 1 NAME OF THE MEDICINAL PRODUCT Doxastad 4 mg prolonged release tablets and associated names [See Annex I] 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-release tablet contains 4 mg doxazosin (as mesilate).
Slovenian: 2 KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta s podaljšanim sproščanjem vsebuje 4 mg doksazosina (v obliki mesilata).
English: 2 BEFORE YOU TAKE DOXASTAD 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES
Slovenian: 12 KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO DOXASTAD 4 MG TABLETE S PODALJŠANIM SPROŠČANJEM IN POVEZANA IMENA
English: If you forget to take use Doxastad 4 mg prolonged release tablets and associated names If you miss a dose, do not worry.
Slovenian: Če ste pozabili vzeti zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena
English: How to store Doxastad 4 mg prolonged release tablets and associated names 6.
Slovenian: Shranjevanje zdravila Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena Dodatne informacije
English: • Drugs indicated for the treatment of erectile dysfunction (PDE-5 inhibitor, e.g. sildenafil, tadalafil, vardenafil)
Slovenian: Povejte zdravniku, če že jemljete katero koli izmed naslednjih zdravil: nesteroidni antirevmatiki; druga zdravila za zdravljenje visokega krvnega tlaka; estrogeni; dopamin, efedrin, adrenalin, metaraminol, metoksamin, fenilefrin (zdravila za zdravljenje bolezni srca); zdravila, indicirana za zdravljenje erektilne disfunkcije (zaviralci PDE-5, npr. sildenafil, tadalafil, vardenafil).
English: Doxastad 4 mg prolonged release tablets and associated names can cause drowsiness.
Slovenian: 12.4 Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena lahko povzroči dremavost.
English: - Benign prostatic hyperplasia and concomitant urinary outflow obstruction, chronic urinary tract infections or bladder stones - Overflow bladder, anuria or progressive renal insufficiency
Slovenian: Preobčutljivost za zdravilno učinkovino, druge kinazoline (npr. prazosin, terazosin) ali katero koli pomožno snov; ezofagealna ali gastrointestinalna obstrukcija v anamnezi ali ocena, da je pri bolniku povečano tveganje za nastanek take obstrukcije; benigna hiperplazija prostate in sočasna obstrukcija sečnih izvodil, kronična okužba sečil ali kamni v mehurju; prelivna inkontinenca, anurija ali progresivna ledvična insufienca.
English: How to take Doxastad 4 mg prolonged release tablets and associated names 4.
Slovenian: Kako jemati zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena Možni neželeni učinki
English: 25 January 2010
Slovenian: 25. januar 2010
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was the United Kingdom and the Concerned Member States were Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Spain, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, the Netherlands, Poland, Portugal, Romania, Slovakia and Slovenia.
Slovenian: Vloga je bila predložena v okviru člena 32 Direktive 2001/82/ES, kakor je bila spremenjena, pri čemer je bila referenčna država članica Združeno kraljestvo, zadevne države članice pa Belgija, Bolgarija, Češka republika, Danska, Estonija, Španija, Nemčija, Grčija, Madžarska, Irska, Italija, Latvija, Litva, Nizozemska, Poljska, Portugalska, Romunija, Slovaška in Slovenija.
English: The final opinion was converted into a Decision by the European Commission on 25 January 2010.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 25. januarja 2010.
English: Opinion following an Article 33 (4)
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 33(4)
English: The Mutual Recognition Procedure UK/V/0335/001/MR started on 29 January 2009.
Slovenian: Postopek medsebojnega priznavanja UK/V/0335/001/MR se je začel dne 29. januarja 2009.
English: 1 Article 33 (4) of Directive 2001/82/EC.
Slovenian: 1 Člen 33(4) Direktive 2001/82/ES.
English: The referral procedure started on 14 July 2009.
Slovenian: Napotitveni postopek se je začel dne 14. julija 2009.
English: The Rapporteur and Co-Rapporteur appointed were Dr. F. Descamps (Belgium) and Dr. A.-M. Brady (the United Kingdom) respectively.
Slovenian: Za poročevalca je bil določen dr. F. Descamps (Belgija), za soporočevalca pa dr. A.-M. Brady (Združeno kraljestvo).
English: On 13 July 2009 the United Kingdom, referred the matter to the Agency under Article 33 (4) of Directive 2001/82/EC due to concerns raised by Belgium regarding an unfavourable benefit and risk balance of the vaccine.
Slovenian: Dne 13. julija 2009 je Združeno kraljestvo v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotilo na Agencijo zaradi zadržkov, ki jih je izpostavila Belgija v zvezi z neugodnim razmerjem med koristmi in tveganji, ki ga je izkazalo cepivo.
English: During its 13-15 October 2009 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by a majority of 25 out of 27 votes an opinion concluding that objections raised by Belgium should not prevent the granting of a Marketing Authorisation.
Slovenian: CVMP je na svojem zasedanju 13.-15. oktobra 2009 ob upoštevanju vseh predloženih podatkov in znanstvene razprave znotraj Odbora z večino glasov (25 od 27) sprejel mnenje, da zadržki, ki jih je izrazila Belgija, ne smejo preprečiti odobritve dovoljenja za promet z zdravilom.
English: Written explanations were provided by the Marketing Authorisation Holder on 17 August 2009.
Slovenian: Imetnik dovoljenja za promet z zdravilom je pisna pojasnila predložil dne 17. avgusta 2009.
English: The Marketing Authorisation Holder (Fort Dodge Animal Health Ltd) submitted an application for Mutual Recognition Procedure of Poulvac Bursa Plus (lyophilisate for suspension in drinking water, 102.2-103.4 EID50/dose), indicated for chickens from 10 days of age for oral administration via the drinking water.
Slovenian: Imetnik dovoljenja za promet z zdravilom (Fort Dodge Animal Health Ltd) je predložil vlogo za postopek za medsebojno priznavanje zdravila Poulvac Bursa Plus (liofilizat za suspenzijo za pitno vodo, 102,2-103,4 EID50/odmerek), indiciranega za piščance od 10 dni starosti za peroralno dajanje s pitno vodo.
English: On the basis of the grounds for referral, the points considered by the CVMP were whether the studies carried out by the Marketing Authorisation Holder were sufficient to address the risks associated with immunosuppression in a comprehensive way and whether the benefit/risk balance was favourable for the vaccine Poulvac Bursa Plus.
Slovenian: Na podlagi razlogov za napotitev je CVMP ugotavljal, ali so bile študije, ki jih je opravil imetnik dovoljenja za promet z zdravilom, zadostne za celovito obravnavo tveganja, povezanega z imunosupresijo, in ali je bilo za cepivo Poulvac Bursa Plus razmerje med koristmi in tveganji ugodno.
English: Poulvac Bursa Plus is a live vaccine against Infectious Bursal Disease Virus (IBDV), also known as Gumboro disease.
Slovenian: Poulvac Bursa Plus je živo cepivo proti virusu Gumborske bolezni (IBDV).
English: Bursa Plus and associated names
Slovenian: za zdravilo Poulvac Bursa Plus in z njim povezana imena
English: Date of first authorisation: 08 January 2018
Slovenian: Datum prve odobritve: 08. januar 2018
English: This is particularly important if you are having major surgery.
Slovenian: To je zlasti pomembno, če boste imeli večji kirurški poseg.
English: Unopened vial 2 years.
Slovenian: Neodprta viala 2 leti.
English: Important note:
Slovenian: Pomembna opomba:
English: Results for the full-analysis population were similar to those for the per-protocol population.
Slovenian: Rezultati analize celotne populacije so bili podobni kot pri populaciji po protokolu.
English: Incremental recovery was comparable with both products.
Slovenian: Prirastno zvečanje aktivnosti (incremental recovery) je bilo primerljivo pri obeh zdravilih.
English: (See section 4 “Possible side effects”).
Slovenian: (Glejte poglavje 4 „Možni neželeni učinki“).
English: The vacuolations did not recover after 2 weeks.
Slovenian: Vakuolizacija po 2 tednih ni bila odpravljena.
English: The osmolality is ≥ 380 mOsmol/kg.
Slovenian: Osmolalnost je ≥ 380 mOsmol/kg.
English: Frequency of doses (hours)/duration of therapy (days)
Slovenian: Pogostnost odmerkov (ure)/trajanje zdravljenja (dnevi)
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Slovenian: Poudariti je treba, da vrednost ABR ni primerljiva med različnimi koncentrati faktorja in med različnimi kliničnimi študijami.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Turn the package over.
Slovenian: Pakiranje obrnite navzdol.
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Repeat injections every 12 to 24 hours.
Slovenian: Injekcije ponavljajte na vsakih 12 do 24 ur.
English: At the end of this period the product shall not be put back in the refrigerator, but shall be used or discarded.
Slovenian: Ob koncu tega obdobja zdravila ne smete vrniti v hladilnik, ampak ga uporabite ali zavrzite.
English: The human coagulation factor VIII has been modified to prolong its duration of action.
Slovenian: Humani koagulacijski faktor VIII je bil spremenjen, da bi se podaljšalo njegovo delovanje.
English: Detailed instructions for self-administration are given at the end of this package leaflet.
Slovenian: Podrobna navodila za samoinjiciranje so navedena na koncu tega navodila za uporabo.
English: The long-term safety of ADYNOVI in children below 12 years has not yet been established.
Slovenian: Dolgoročna varnost zdravila ADYNOVI pri otrocih, mlajših od 12 let, še ni bila dokazana.
English: Uncommon (PTPs)*
Slovenian: občasni (PZB)*
English: • Administer as soon as possible, but no later than 3 hours after reconstitution.
Slovenian: • Raztopino uporabite čim prej oziroma v največ 3 urah po rekonstituciji.
English: Frequencies have been evaluated according to the following convention: 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: Pogostnosti so bile opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do <1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Do not draw air into the syringe.
Slovenian: V brizgo ne povlecite zraka.
English: A higher dose may be required in children less than 12 years of age, see section 4.2.
Slovenian: Pri otrocih, mlajših od 12 let, je morda potreben večji odmerek, glejte poglavje 4.2.
English: Use within 3 hours of reconstitution.
Slovenian: Uporabite v 3 urah po rekonstituciji.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Slovenian: Uporabljena količina zdravila in pogostnost uporabe naj bosta vedno usmerjena v klinično učinkovitost pri vsakem posameznem bolniku.
English: ADYNOVI can be used only in adolescents and adults (12 years and above).
Slovenian: Zdravilo ADYNOVI se sme uporabljati samo pri mladostnikih in odraslih (starih 12 let in več).
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če se zdravila ne uporabi takoj, je za čas in pogoje shranjevanja odgovoren uporabnik.