FrancophonIA/ELRC3.0 huggingface dataset:
English: Riprazo HCT 150 mg/25 mg film-coated tablets
Slovenian: Riprazo HCT 150 mg/25 mg filmsko obložene tablete
English: Riprazo HCT 300 mg/25 mg film-coated tablets
Slovenian: Riprazo HCT 300 mg/25 mg filmsko obložene tablete
English: There is no clinical experience with Riprazo HCT in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter ni kliničnih izkušenj z zdravilom Riprazo HCT.
English: The pharmacokinetics of aliskiren are not significantly affected in patients with mild to moderate liver disease.
Slovenian: Farmakokinetične lastnosti aliskirena pri bolnikih z blago do zmerno hudo boleznijo jeter niso bistveno spremenjene, zato pri bolnikih z blago do zmerno okvaro jeter prilagajanje začetnega odmerka zdravila Riprazo HCT ni potrebno.
English: Riprazo HCT 300 mg /25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 25 mg alone or by Riprazo HCT 300 mg/12.5 mg or Riprazo HCT 150 mg/25 mg.
Slovenian: Zdravilo Riprazo HCT 300 mg/25 mg je mogoče uporabljati pri bolnikih, katerih krvni tlak ni ustrezno urejen, če uporabljajo samo aliskiren v odmerku 300 mg ali samo hidroklorotiazid v odmerku 25 mg ali če uporabljajo zdravilo Riprazo HCT 300 mg/12,5 mg ali Riprazo HCT 150 mg/25 mg.
English: Due to the hydrochlorothiazide component, Riprazo HCT is contraindicated in symptomatic hyperuricaemia (see section 4.3).
Slovenian: Zaradi vsebnosti hidroklorotiazida je pri bolnikih s simptomatsko hiperurikemijo uporaba zdravila Riprazo HCT kontraindicirana (glajte poglavje 4.3).
English: Riprazo HCT 300 mg/12.5 mg film-coated tablets
Slovenian: Riprazo HCT 300 mg/12,5 mg filmsko obložene tablete
English: Dizziness
Slovenian: driska
English: Riprazo HCT 150 mg/12.5 mg film-coated tablets
Slovenian: Riprazo HCT 150 mg/12,5 mg filmsko obložene tablete
English: • Dizziness
Slovenian: • driska.
English: No data are available on patients with severe hepatic impairment treated by Riprazo HCT.
Slovenian: O bolnikih s hudo okvaro jeter, ki jemljejo zdravilo Riprazo HCT, ni podatkov.
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PVC/PCTFE BLISTERS
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA, KI VSEBUJE PRETISNE OMOTE IZ PVC/PCTFE (VKLJUČNO Z “BLUE BOX” PODATKI)
English: FOLDING BOX FOR UNIT PACK CONTAINING PA/ALU/PVC BLISTERS
Slovenian: ŠKATLA ZA POSAMIČNO PAKIRANJE, KI VSEBUJE PRETISNE OMOTE IZ PA/ALU/PVC
English: Common (affecting less than 1 in 10 patients):
Slovenian: Pogosti (pojavijo se pri manj kot 1 od 10 bolnikov):
English: No adjustment of the initial dose is required for patients with mild to moderate hepatic impairment.
Slovenian: Bolnikom z blago do zmerno okvaro jeter ni treba treba prilagajati začetnega odmerka.
English: Riprazo HCT 150 mg /12.5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or hydrochlorothiazide 12.5 mg alone.
Slovenian: Zdravilo Riprazo HCT 150 mg/12,5 mg je mogoče uporabljati pri bolnikih, katerih krvni tlak ni ustrezno urejen, če uporabljajo samo aliskiren v odmerku 150 mg ali samo hidroklorotiazid v odmerku 12,5 mg.
English: INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Slovenian: VMESNA ŠKATLA V SKUPNEM PAKIRANJU, KI VSEBUJE PRETISNE OMOTE IZ PA/ALU/PVC (BREZ “BLUE BOX” PODATKOV)
English: - Each Riprazo HCT 300 mg/25 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide.
Slovenian: - Vsaka filmsko obložena tableta Riprazo HCT 300 mg/25 mg vsebuje 300 mg aliskirena (v obliki hemifumarata) in 25 mg hidroklorotiazida.
English: Riprazo HCT 300 mg/12.5 mg film-coated tablets are violet white, oval film-coated tablets imprinted with “CVI” on one side and “NVR” on the other.
Slovenian: Filmsko obložene tablete Riprazo HCT 300 mg/12,5 mg so vijoličasto bele ovalne filmsko obložene tablete z oznako “CVI” na eni strani in “NVR” na drugi.
English: Riprazo HCT 300 mg/25 mg film-coated tablets are light yellow, oval film-coated tablets imprinted with “CVV” on one side and “NVR” on the other.
Slovenian: Filmsko obložene tablete Riprazo HCT 300 mg/25 mg so svetlo rumene ovalne filmsko obložene tablete z oznako “CVV” na eni strani in “NVR” na drugi.
English: Abdominal discomfort, constipation, diarrhoea
Slovenian: omotičnost, glavobol, parestezija
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA, KI VSEBUJE PRETISNE OMOTE IZ PA/ALU/PVC (VKLJUČNO Z “BLUE BOX” PODATKI)
English: (asthenia)
Slovenian: (vaskulitis),
English: Pale yellow, biconvex, ovaloid film-coated tablet imprinted with “CLL” on one side and “NVR” on the other.
Slovenian: Bledo rumena, bikonveksna ovalna filmsko obložena tableta z vtisnjeno oznako “CLL” na eni strani in “NVR” na drugi.
English: Riprazo HCT 150 mg /25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or hydrochlorothiazide 25 mg alone or by Riprazo HCT 150 mg/12.5 mg.
Slovenian: Zdravilo Riprazo HCT 150 mg/25 mg je mogoče uporabljati pri bolnikih, katerih krvni tlak ni ustrezno urejen, če uporabljajo samo aliskiren v odmerku 150 mg ali samo hidroklorotiazid v odmerku 25 mg ali če uporabljajo zdravilo Riprazo HCT 150 mg/12,5 mg.
English: Uncommon (affecting less than 1 in 100 patients):
Slovenian: Občasni (pojavijo se pri manj kot 1 od 100 bolnikov):
English: Hypromellose Macrogol
Slovenian: hipokloremična alkaloza
English: HOW TO STORE RIPRAZO HCT
Slovenian: SHRANJEVANJE ZDRAVILA RIPRAZO HCT
English: Riprazo HCT 150 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Slovenian: Riprazo HCT 150 mg/25 mg filmsko obložene tablete aliskiren/hidroklorotiazid
English: Riprazo HCT 300 mg /12.5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 12.5 mg alone or by Riprazo HCT 150 mg/12.5 mg.
Slovenian: Zdravilo Riprazo HCT 300 mg/12,5 mg je mogoče uporabljati pri bolnikih, katerih krvni tlak ni ustrezno urejen, če uporabljajo samo aliskiren v odmerku 300 mg ali samo hidroklorotiazid v odmerku 12,5 mg ali če uporabljajo zdravilo Riprazo HCT 150 mg/12,5 mg.
English: Light yellow, biconvex, ovaloid film-coated tablet imprinted with “CVV” on one side and “NVR” on the other.
Slovenian: Svetlo rumena, bikonveksna ovalna filmsko obložena tableta z vtisnjeno oznako “CVV” na eni strani in “NVR” na drugi.
English: Riprazo HCT 300 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Slovenian: Riprazo HCT 300 mg/25 mg filmsko obložene tablete aliskiren/hidroklorotiazid
English: Riprazo HCT 150 mg/12.5 mg film-coated tablets Aliskiren/hydrochlorothiazide
Slovenian: Riprazo HCT 150 mg/12,5 mg filmsko obložene tablete aliskiren/hidroklorotiazid
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg aliskirena (v obliki hemifumarata) in 12,5 mg hidroklorotiazida.
English: White, biconvex, ovaloid film-coated tablet imprinted with “LCI” on one side and “NVR” on the other.
Slovenian: Bela, bikonveksna ovalna filmsko obložena tableta z vtisnjeno oznako “LCI” na eni strani in “NVR” na drugi.
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 300 mg aliskirena (v obliki hemifumarata) in 12,5 mg hidroklorotiazida.
English: Riprazo HCT 300 mg/12.5 mg film-coated tablets Aliskiren/hydrochlorothiazide
Slovenian: Riprazo HCT 300 mg/12,5 mg filmsko obložene tablete aliskiren/hidroklorotiazid
English: Riprazo HCT is contraindicated in patients with anuria or severe renal impairment (GFR < 30 ml/min/1.73 m2) and the concomitant use of Riprazo HCT with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m
Slovenian: Pri bolnikih z okvaro ledvic (GFR < 60 ml/min/1,73 m2) je sočasna uporaba aliskirena in zaviralcev ACE ali zaviralcev angiotenzinskih receptorjev II kontraindicirana.
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg aliskirena (v obliki hemifumarata) in 25 mg hidroklorotiazida.
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 300 mg aliskirena (v obliki hemifumarata) in 25 mg hidroklortoiazida.
English: The use of aliskiren in combination with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Slovenian: Sočasna uporaba zdravila Riprazo HCT in zaviralcev angiotenzinskih receptorjev II ali zaviralcev ACE je kontraindicirana pri bolnikih z okvaro ledvic (GFR < 60 ml/min/1,73 m2) (glejte poglavje 4.3).
English: Violet white, biconvex, ovaloid film-coated tablet imprinted with “CVI” on one side and “NVR” on the other.
Slovenian: Vijoličasto bela, bikonveksna ovalna filmsko obložena tableta z vtisnjeno oznako “CVT” na eni strani in “NVR” na drugi.
English: Side effects reported in clinical studies for patients treated with Riprazo HCT were: Common (affecting less than 1 in 10 patients):
Slovenian: V kliničnih študijah so pri bolnikih, ki so prejemali zdravilo Riprazo HCT, opisali naslednje neželene učinke:
English: - if you suffer from liver problems.
Slovenian: • bolečine v trebuhu,
English: Hypersensitivity reactions Skin and subcutaneous tissue disorders Uncommon:
Slovenian: ortostatska hipotenzija Bolezni dihal, prsnega koša in mediastinalnega prostora zelo redki:
English: Riprazo HCT should be discontinued if hypercalcaemia develops during treatment.
Slovenian: Če pride med zdravljenjem do razvoja hiperkalciemije, je treba uporabo zdravila Riprazo HCT prekiniti.
English: Heart failure
Slovenian: srčne aritmije
English: Concomitant use of Riprazo HCT with ARBs or ACEIs is contraindicated in patients with diabetes mellitus (see section 4.3).
Slovenian: RiprazoRiprazoPri bolnikih s hudo okvaro ledvic in pri bolnikih z anurijo je uporaba zdravila Riprazo HCT kontraindicirana (glejte poglavje 4.3).
English: Skin and subcutaneous tissue disorders Common:
Slovenian: Bolezni koţe in podkoţja pogosti:
English: The concomitant use of aliskiren and ACEIs or ARBs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2).
Slovenian: Zdravilo Riprazo HCT kontraindicirano pri bolnikih z anurijo in pri bolnikih s hudo okvaro ledvic (s GFR < 30 ml/min/1,73 m2).
English: No dosage adjustment is necessary in patients with mild to moderate renal impairment (GFR ≥ 30 ml/min/1.73 m
Slovenian: Bolnikom z blago do zmerno okvaro ledvic (GFR ≥ 30 ml/min/1,73 m 2) ni treba prilagajati odmerkov.RiprazoRiprazo
English: Always take Riprazo HCT exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Riprazo HCT natančno upoštevajte zdravnikova navodila.
English: Severe hepatic impairment.
Slovenian: • zvišana telesna temperatura.
English: Arthralgia Renal and urinary disorders Uncommon:
Slovenian: urtikarija in druge oblike izpuščaja redki: zelo redki:
English: Diarrhoea: Diarrhoea is a dose-related adverse drug reaction for aliskiren.
Slovenian: Driska: Driska je od odmerka odvisen neželeni učinek aliskirena.
English: - anticholinergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia).
Slovenian: (zdravila za zdravljenje težav s srcem) in nekateri antipsihotiki, - zdravila, ki lahko znižajo količino natrija v krvi, kot so antidepresivi, antipsihotiki in antiepileptiki (karbamazepin), - zdravila za lajšanje bolečin, kot so nesteroidna protivnetna zdravila (NSAID), vključno s selektivnimi zaviralci ciklooksigenaze-2 (zaviralci Cox-2), - zdravila za znižanje krvnega tlaka, vključno z metildopo, - zdravila za zvišanje krvnega tlaka, kot sta noradrenalin ali adrenalin, - digoksin ali druge glikozide digitalisa (zdravila za zdravljenje težav s srcem), - vitamin D in kalcijeve soli, - zdravila za zdravljenje sladkorne bolezni (peroralnih zdravil, kot je metformin, ali insulini), - zdravila, ki lahko zvišajo raven sladkorja v krvi (zaviralce adrenergičnih receptorjev beta,
English: Excipients
Slovenian: Riprazo
English: It is important to tell your doctor if you are taking:
Slovenian: Pomembno je, da zdravnika obvestite, če jemljete:
English: Special warnings and precautions for use or 4.5.
Slovenian: Posebna opozorila in previdnostni ukrepi ali 4.5.
English: 2 - What you need to know before you take {product name}
Slovenian: 2 - Kaj morate vedeti, preden boste vzeli zdravilo {ime zdravila}
English: Interaction not studied with any of the components of <product name>.
Slovenian: Medsebojno delovanje ni bilo proučevano z nobeno od sestavin zdravila <ime zdravila>.
English: Moreover, the tables with information on interactions should be modified according to the following instructions:
Slovenian: Poleg tega je treba preglednice s podatki o medsebojnem delovanju posodobiti v skladu z naslednjimi navodili:
English: Adopted at the 30 August-2 September 2016 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 30. avgustom in 2. septembrom 2016
English: N.B: For Evotaz, Section 4.4 warning should be maintained.
Slovenian: OPOMBA: Pri zdravilu Evotaz je treba ohraniti opozorilo v poglavju 4.4.
English: Note: it is acknowledged that the package leaflet for some products may need to be slightly modified in order to incorporate the above message.
Slovenian: Opomba: priznava se, da je za vključitev navedenega sporočila navodilo za uporabo morda treba nekoliko prilagoditi.
English: 2 - What you need to know before you <take> <use> {product name} Other medicines and {product name} <Tell your <doctor> <or> <pharmacist> if you are <taking> <using>, have recently <taken> <used> or might <take> <use> any other medicines.> Warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Slovenian: 2 - Kaj morate vedeti, preden boste <vzeli> <uporabili> zdravilo {ime zdravila} Druga zdravila in zdravilo {ime zdravila} <Obvestite <zdravnika> <ali> <farmacevta>, če <jemljete> <uporabljate>, ste pred kratkim <jemali> <uporabljali> ali pa boste morda začeli <jemati> <uporabljati> katero koli drugo zdravilo.> Varfarin in druga podobna zdravila, imenovana antagonisti vitamina K, ki se uporabljajo za redčenje krvi.
English: Haemolytic anaemia (abnormal breakdown of red blood cells, which may cause fatigue, rapid heart rate and shortness of breath)
Slovenian: Hemolitična anemija (nenormalno razpadanje rdečih krvnih celic, ki lahko povzroči utrujenost, hitro bitje srca in kratko sapo)
English: Frequency “rare”: Inability to completely empty the bladder
Slovenian: Pogostnost: „redki“: nezmožnost popolne izpraznitve sečnega mehurja
English: Blood and lymphatic system disorders (frequency not known): Haemolytic anaemia
Slovenian: Bolezni krvi in limfatičnega sistema (neznana pogostnost): Hemolitična anemija
English: Plasma concentrations of these medicinal products may be increased when coadministered with <product name>, resulting in reduced serum cortisol concentrations.
Slovenian: Plazemske koncentracije teh zdravil se lahko ob sočasnem dajanju zdravila <ime zdravila> povečajo, kar povzroči zmanjšanje serumskih koncentracij kortizola.
English: Summary of product characteristics of corticosteroids (excluding topical formulations)
Slovenian: Povzetek glavnih značilnosti kortikosteroidov (razen formulacij za lokalno uporabo)
English: Agomelatine - Urinary retention (EPITT no 18637)
Slovenian: Agomelatin - zastajanje urina (EPITT-št. 18637)
English: Interaction with other medicinal products and other forms of interaction Patients treated with vitamin K antagonists:
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Bolniki, ki se zdravijo z antagonisti vitamina K:
English: This is due to liver function changes during treatment with {product name}.
Slovenian: Razlog za to so spremembe delovanja jeter pri zdravljenju z zdravilom {ime zdravila}.
English: Interaction with other medicinal products and other forms of interaction, as appropriate
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij, kot je primerno
English: As liver function may change during treatment with {product name}, a close monitoring of International Normalised Ratio (INR) values is recommended.
Slovenian: Ker se delovanje jeter v času zdravljenja z zdravilom {ime zdravila} lahko spremeni, se priporoča natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR).
English: Cases of Cushing's syndrome and adrenal suppression have been reported.
Slovenian: Poročali so o primerih Cushingovega sindroma in supresije nadledvičnih žlez.
English: For Olysio, Viekirax and Exviera (products for which pharmacokinetic studies with warfarin have been performed)
Slovenian: Pri zdravilih Olysio, Viekirax in Exviera (zdravila, pri katerih so bile opravljene farmakokinetične študije z varfarinom)
English: For Victrelis, Sovaldi, Harvoni, Daklinza, Zepatier and Epclusa (products for which pharmacokinetic studies with warfarin have not been performed)
Slovenian: Pri zdravilih Victrelis, Sovaldi, Harvoni, Daklinza, Zepatier in Epclusa (zdravila, pri katerih farmakokinetične študije z varfarinom niso bile opravljene)
English: Boceprevir ; daclatasvir; dasabuvir; elbasvir, grazoprevir; ledipasvir, sofosbuvir; ombitasvir, paritaprevir, ritonavir; simeprevir; sofosbuvir; sofosbuvir, velpatasvir - Drug interaction between direct-acting antivirals (DAAV) and vitamin K antagonists leading to a reduced international normalised ratio (INR) (EPITT no 18654)
Slovenian: Boceprevir ; daklatasvir; dasabuvir; elbasvir, grazoprevir; ledipasvir, sofosbuvir; ombitasvir, paritaprevir, ritonavir; simeprevir; sofosbuvir; sofosbuvir, velpatasvir - medsebojno delovanje neposredno delujočih protivirusnih zdravil in antagonistov vitamina K, ki vodi k zmanjšanju mednarodnega normaliziranega razmerja (INR) (EPITT-št. 18654)
English: Iomeprol - Haemolysis (EPITT no 18625)
Slovenian: Jomeprol - hemoliza (EPITT-št. 18625)
English: Warfarin and other vitamin K antagonists
Slovenian: Varfarin in drugi antagonisti vitamina K
English: Concomitant use of <product name> and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression
Slovenian: Sočasna uporaba zdravila <ime zdravila> in kortikosteroidov, ki se presnavljajo s pomočjo encimov CYP3A (npr flutikazonpropionata in drugih inhaliranih ali nazalnih kortikosteroidov) lahko poveča tveganje za razvoj sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in supresijo nadledvičnih žlez.
English: Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Slovenian: kortikosteroide, vključno z betametazonom, budezonidom, flutikazonom, mometazonom, prednizonom, triamcinolonom.
English: Results of interaction studies with warfarin should be included here as applicable
Slovenian: Tu naj bodo smiselno vključeni rezultati študij medsebojnega delovanja z varfarinom.
English: Cobicistat containing products: cobicistat; cobicistat, atazanavir sulfate; cobicistat, darunavir; cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide; cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil fumarateDrug interaction with corticosteroids leading to adrenal suppression (EPITT no 18647)
Slovenian: Zdravila, ki vsebujejo kobicistat: kobicistat; kobicistat, atazanavirjev sulfat; kobicistat, darunavir; kobicistat, elvitegravir, emtricitabin, alafenamidtenofovirat; kobicistat, elvitegravir, emtricitabin, dizoproksiltenofovirijev fumaratmedsebojno delovanje s kortikosteroidi, ki vodi v supresijo nadledvičnih žlez (EPITT-št. 18647)
English: Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Slovenian: Kortikosteroidi, ki se primarno presnavljajo s pomočjo encimov CYP3A (vključno z betametazonom, budezonidom, flutikazonom, mometazonom, prednizonom, triamcinolonom).
English: The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid effects.
Slovenian: Te kombinacije se je treba izogibati, razen kadar koristi odtehtajo povečano tveganje za sistemske neželene učinke kortikosteroidov.
English: Undesirable effects Renal and urinary disorders Frequency “rare”: Urinary retention
Slovenian: Pogostnost: „redki“: zastajanje urina
English: Summary of product characteristics of cobicistat containing products
Slovenian: Povzetek glavnih značilnosti zdravil , ki vsebujejo kobicistat
English: Package leaflet of cobicistat containing products
Slovenian: Navodilo za uporabo zdravil, ki vsebujejo kobicistat
English: EMA/PRAC/551910/2016
Slovenian: Novo besedilo informacij o zdravilu - izvlečki iz priporočil odbora PRAC o signalih EMA/PRAC/603543/2016
English: Interaction not studied Close monitoring of INR is recommended with all vitamin K antagonists.
Slovenian: Pri vseh antagonistih vitamina K se priporoča natančno spremljanje vrednosti INR.
English: Alternative corticosteroids which are less dependent on CYP3A metabolism e.g.
Slovenian: Zlasti pri dolgotrajni uporabi je treba premisliti o uporabi drugih kortikosteroidov, ki so manj odvisni od presnove s pomočjo encimov CYP3A, npr. beklometazona za intranazalno uporabo ali inhaliranje.
English: Undesirable effects
Slovenian: Bolezni sečil
English: France/ Luxembourg/ Portugal/ Italy/ Sweden/ Finland/ Czech Republic/ Slovakia/ Hongary/ Bulgaria/ Romania/ Croatia/ Slovenia/ Republic of Cyprus/ Denmark/ Estonia/ Latvia/ Lithuania/ Malta:
Slovenian: Francija / Luksemburg / Portugalska / Italija / Švedska / Finska / Češka / Slovaška / Hongary / Bolgarija / Romunija / Hrvaška / Slovenija / Republika Ciper / Danska / Estonija:
English: Do not refrigerate or freeze.
Slovenian: Ne shranjujte v hladilniku ali zamrzovalniku.
English: Ornamental birds, particularly:
Slovenian: Okrasne ptice, zlasti:
English: (See section “Adverse reactions”.)
Slovenian: (Glejte poglavje Neželeni učinki.)
English: United Kingdom Petlife International Ltd.
Slovenian: Združeno kraljestvo Petlife International Ltd.
English: ATCvet code: QJ02AC02.
Slovenian: oznaka ATC vet: QJ02AC02.
English: Dose and treatment schedule:
Slovenian: Razpored odmerjanja in zdravljenja:
English: Detailed information on this veterinary medicine is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
English: Where there is more than one bird in the home/cage, all infected and treated birds should be separated from other birds.
Slovenian: Če je v domu/kletki več ptic, je treba vse okužene in zdravljene ptice ločiti od drugih ptic.
English: Dechra Veterinary Products GmbH-Austria Hintere Achmühlerstraße 1A 6850 Dornbirn
Slovenian: Dechra Veterinary Products GmbH-Avstrija Hintere Achmühlerstraße 1A 6850 Dornbirn
English: For the treatment of aspergillosis.
Slovenian: Za zdravljenje aspergiloze.
English: Frequent and repeated use of antifungals from the same class may increase the risk of development of resistance to that class of antifungals.
Slovenian: Pogosta in ponavljajoča uporaba antimikotikov istega razreda lahko poveča tveganje razvoja odpornosti proti temu razredu antimikotikov.
English: Dechra Veterinary Products/Albrecht GmbH Veterinär-medizinische Erzeugnisse Hauptstr.
Slovenian: Veterinarski izdelki Dechra / Albrecht GmbH Veterinär-medizinische Erzeugnisse Hauptstr.