FrancophonIA/ELRC3.0 huggingface dataset:
English: ALPROLIX (eftrenonacog alfa) is a long-acting, fully recombinant, fusion protein comprising human coagulation factor IX covalently linked to the Fc domain of human immunoglobulin G1, and produced by recombinant DNA technology.
Slovenian: sestavljena iz humanega koagulacijskega faktorja IX, kovalentno vezanega na domeno Fc humanega imunoglobulina G1, in izdelana s pomočjo tehnologije rekombinantne DNA.
English: For subjects in the individualised interval arm, the median dosing interval was 12.53 days (IQR: 10.4-13.4) in Study I. The corresponding median ABR was 1.38 (IQR: 0.00-3.43) and remained similar throughout Study III (1.85 (IQR: 0.76-4.0)).
Slovenian: 12,53 dneva (IQR: 10,4-13,4) v študiji I. Ustrezna mediana ABR je bila 1,38 (IQR: 0,00-3,43) in je v študiji III ostala podobna (1,85 (IQR: 0,76-4,0)).
English: 250 IU 500 IU 1000 IU 2000 IU 3000 IU
Slovenian: 250 i.e. 500 i.e. 1000 i.e. 2000 i.e. 3000 i.e.
English: 1PK parameters derived from noncompartmental analysis are presented in Geometric Mean (95% CI) Abbreviations: CI = confidence interval; IR = incremental recovery; AUC = area under the FIX activity time curve; t1/2 = terminal half-life; MRT = mean residence time; CL = clearance; Vss = volume of distribution at steady-state
Slovenian: IZ = interval zaupanja; AUC = površina pod krivuljo aktivnosti FIX v odvisnosti od časa (area under time curve); t½ = končni razpolovni čas; MRT = povprečni čas zadrževanja (mean residence time); Vss = volumen porazdelitve v stanju dinamičnega ravnovesja (volume of distribution at steady-state)
English: How to use ALPROLIX
Slovenian: Kako uporabljati zdravilo ALPROLIX
English: ALPROLIX 250 IU powder and solvent for solution for injection
Slovenian: ALPROLIX 250 i.e. prašek in vehikel za raztopino za injiciranje
English: It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Slovenian: Treba je omeniti, da so lahko bolniki z zaviralci faktorja IX pri poznejši provokaciji s faktorjem IX izpostavljeni povečanemu tveganju anafilaksije.
English: 1 Pharmacokinetic parameters are presented in Geometric Mean (95% CI) 2 These pharmacokinetic parameters obtained from the compartmental analysis Abbreviations: CI = confidence interval; Cmax= maximum activity; AUC = area under the FIX activity time curve; t1/2 = terminal half-life; t½α = distribution half-life; t½β = elimination half-life; CL = clearance; Vss = volume of distribution at steady-state; MRT = mean residence time.
Slovenian: Okrajšave: IZ =interval zaupanja; Cmax = največja aktivnost; AUC = površina pod krivuljo aktivnosti FIX v odvisnosti od časa (area under time curve); t½ = končni razpolovni čas, t½α = porazdelitveni razpolovni čas; t½β = razpolovni čas izločanja; Vss = volumen porazdelitve v stanju dinamičnega ravnovesja (volume of distribution at steady-state); MRT = povprečni čas zadrževanja (mean residence time).
English: The powder is a white to offwhite powder or cake.
Slovenian: Prašek je bel do belkast prašek ali pogača.
English: Median weekly dose for subjects in the fixed weekly arm was 45.17 IU/kg (interquartile range (IQR) 38.153.7) in Study I. The corresponding median Annualised Bleeding Rates (ABR) in subjects evaluable for efficacy were 2.95 (IQR: 1.01-4.35) and remained similar throughout Study III (1.85 (IQR: 0.76-4.0)).
Slovenian: 45,17 i.e./kg (interkvartilni razpon (IQR - interquartile range) 38,1-53,7) v študiji I. Ustrezna mediana letnega deleža krvavitve (ABR - annualised bleeding rate) pri preizkušancih, pri katerih je bilo mogoče oceniti učinkovitost, je bila 2,95 (IQR: 1,01-4,35) in je ostala podobna tudi v študiji III (1,85 (IQR:
English: ALPROLIX contains sodium
Slovenian: Zdravilo ALPROLIX vsebuje natrij
English: Please see package leaflet, for additional information on reconstitution and administration.
Slovenian: Za dodatne informacije o rekonstituciji in dajanju glejte navodilo za uporabo.
English: Signs of allergic reactions may include, generalised itching, hives, tightness of the chest, difficulty breathing and low blood pressure.
Slovenian: koprivnico, stiskanje v prsnem košu, težave z dihanjem in nizek krvni tlak.
English: Attach the syringe with the prepared ALPROLIX solution to the end of the infusion set tubing by turning clockwise.
Slovenian: Z obračanjem v smeri urnega kazalca pritrdite injekcijsko brizgo s pripravljeno raztopino zdravila ALPROLIX na konec cevke infuzijskega kompleta.
English: Content: 1 powder vial, 5 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol swabs, 2 plasters, 1 gauze
Slovenian: Vsebina: 1 viala s praškom, 5 ml vehikla v napolnjeni injekcijski brizgi, 1 nosilec za bat brizge, 1 nastavek za vialo, 1 infuzijski komplet, 2 alkoholna zloženca, 2 obliža, 1 gaza
English: If you are not sure what to do, ask your doctor, pharmacist or nurse.
Slovenian: Če niste prepričani, kako ravnati, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: With the syringe still connected to the adapter and the plunger rod pressed down, gently swirl the vial until the powder is dissolved.
Slovenian: Z injekcijsko brizgo, pritrjeno na nastavek, in nosilcem za bat brizge, stisnjenim navzdol, vialo nežno obračajte, da se prašek raztopi.
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Slovenian: Po poskusu indukcije imunske tolerance pri bolnikih s hemofilijo B z zaviralci faktorja IX in alergijskimi reakcijami v anamnezi so poročali o nefrotskem sindromu.
English: General disorders and administration site conditions Fatigue Infusion site pain
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost bolečina na mestu infundiranja občasni občasni
English: Place the vial on a flat surface.
Slovenian: Vialo postavite na ravno površino.
English: Solvent for ALPROLIX sodium chloride water for injections
Slovenian: vehikel za zdravilo ALPROLIX natrijev klorid voda za injekcije
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Slovenian: L-histidin manitol polisorbat 20 natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH)
English: Firmly push and turn the syringe clockwise until it is securely connected.
Slovenian: Injekcijsko brizgo čvrsto potiskajte in obračajte v smeri urnega kazalca, dokler ni dobro pritrjena.
English: Attach the plunger rod (C) to the solvent syringe by inserting the tip of the plunger rod into the opening in the syringe plunger.
Slovenian: Nosilec za bat brizge (C) nataknite na injekcijsko brizgo z vehiklom tako, da vstavite konico nosilca v odprtino bata injekcijske brizge.
English: 48h
Slovenian: 18 let.
English: The reconstituted solution should be clear to slightly opalescent and colourless.
Slovenian: Rekonstituirana raztopina mora biti bistra do rahlo opalescentna in brezbarvna.
English: ALPROLIX is given as an injection into a vein.
Slovenian: Zdravilo ALPROLIX se daje v veno s pomočjo injekcije.
English: Solvent: the solution is clear to colourless.
Slovenian: Vehikel: raztopina je bistra do brezbarvna.
English: Solvent: sodium chloride, water for injections
Slovenian: Vehikel: natrijev klorid, voda za injekcije
English: ALPROLIX is provided as a powder and solvent for solution for injection.
Slovenian: Zdravilo ALPROLIX je na voljo v obliki praška in vehikla za raztopino za injiciranje.
English: Each pack of ALPROLIX contains 1 powder vial, 5 mL solvent in pre-filled syringe, 1plunger rod, 1vial adapter, 1 infusion set, 2 alcohol swabs, 2 plasters and 1 gauze pad
Slovenian: Eno pakiranje zdravila ALPROLIX vsebuje 1 vialo s praškom, 5 ml vehikla v napolnjeni injekcijski brizgi, 1 nosilec za bat brizge, 1 nastavek za vialo, 1 infuzijski komplet, 2 alkoholna zloženca, 2 obliža, 1 gazo.
English: After preparation, the solution to inject is clear to slightly opalescent and colourless.
Slovenian: Po pripravi je raztopina, ki se injicira, bistra do blago opalescentna in brezbarvna.
English: Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening.
Slovenian: Injekcijsko brizgo z vehiklom povežite z nastavkom na viali tako, da konico injekcijske brizge vtaknete v odprtino nastavka.
English: Do not use if the product has expired.
Slovenian: Zdravila, ki mu je potekel rok uporabnosti, ne uporabite.
English: Protect the solution from direct sunlight.
Slovenian: Raztopino zaščitite pred neposredno sončno svetlobo.
English: Decreased appetite
Slovenian: Presnovne in prehranske motnje zmanjšan apetit občasni
English: ALPROLIX 250 IU powder for injection ALPROLIX 500 IU powder for injection ALPROLIX 1000 IU powder for injection ALPROLIX 2000 IU powder for injection ALPROLIX 3000 IU powder for injection eftrenonacog alfa recombinant coagulation factor IX IV
Slovenian: ALPROLIX 250 i.e. prašek za injekcijo ALPROLIX 500 i.e. prašek za injekcijo ALPROLIX 1000 i.e. prašek za injekcijo ALPROLIX 2000 i.e. prašek za injekcijo ALPROLIX 3000 i.e. prašek za injekcijo eftrenonacogum alfa rekombinantni koagulacijski faktor IX i.v.
English: ALPROLIX contains the active substance eftrenonacog alfa, recombinant coagulation factor IX, Fc fusion protein.
Slovenian: Zdravilo ALPROLIX vsebuje učinkovino eftrenonakog alfa, rekombinantni koagulacijski faktor IX,
English: ALPROLIX 500 IU powder and solvent for solution for injection ALPROLIX 1000 IU powder and solvent for solution for injection ALPROLIX 2000 IU powder and solvent for solution for injection ALPROLIX 3000 IU powder and solvent for solution for injection eftrenonacog alfa recombinant coagulation factor IX, Fc fusion protein This medicine is subject to additional monitoring.
Slovenian: ALPROLIX 500 i.e. prašek in vehikel za raztopino za injiciranje ALPROLIX 1000 i.e. prašek in vehikel za raztopino za injiciranje ALPROLIX 2000 i.e. prašek in vehikel za raztopino za injiciranje ALPROLIX 3000 i.e. prašek in vehikel za raztopino za injiciranje eftrenonakog alfa (eftrenonacogum alfa), rekombinantni koagulacijski faktor XI, fuzijska beljakovina Fc Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Once you have prepared ALPROLIX it should be used right away.
Slovenian: Pripravljeno zdravilo ALPROLIX takoj uporabite.
English: Animal reproduction studies have not been conducted with ALPROLIX.
Slovenian: Študij o vplivu zdravila ALPROLIX na sposobnost razmnoževanja pri živalih niso izvedli.
English: Alternatively, ALPROLIX may be stored at room temperature (up to 30°C) for a single period not exceeding 6 months.
Slovenian: Zdravilo ALPROLIX lahko shranite tudi pri sobni temperaturi (do 30 °C), in sicer za enkratno obdobje največ 6 mesecev.
English: ALPROLIX 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU eftrenonacog alfa.
Slovenian: ALPROLIX 250 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 250 i.e. eftrenonakoga alfa (eftrenonacogum alfa).
English: The median overall dose to treat a bleeding episode was 51.47 IU/kg (IQR: 35.21-61.73) in the weekly prophylaxis arm, 49.62 IU/kg (IQR: 35.71-94.82) in the individualised interval prophylaxis arm and 46.58 IU/kg (IQR: 33.
Slovenian: 49,62 i.e./kg (IQR: 35,71-94,82) pri profilaktičnem individualiziranem intervalu in 46,58 i.e./kg (IQR:
English: In a placental transfer study, ALPROLIX has been shown to cross the placenta in small amounts in mice.
Slovenian: ALPROLIX v majhnih količinah prehaja skozi posteljico.
English: powder and solvent for solution for injection
Slovenian: prašek in vehikel za raztopino za injiciranje
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Slovenian: pekoč občutek in zbadanje na mestu infundiranja, mrzlico, zardevanje, generalizirano urtikarijo, glavobol, koprivnico, hipotenzijo, letargijo, navzeo, nemirnost, tahikardijo, stiskanje v prsnem košu, mravljinčenje,
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE IN IZDELOVALEC
English: Talk to your doctor, pharmacist or nurse before using ALPROLIX.
Slovenian: Pred začetkom uporabe zdravila ALPROLIX se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: ALPROLIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU eftrenonacog alfa.
Slovenian: ALPROLIX 2000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2000 i.e. eftrenonakoga alfa (eftrenonacogum alfa).
English: How ALPROLIX works
Slovenian: Delovanje zdravila ALPROLIX
English: In children below the age of 12 years, higher doses or more frequent injections may be needed and the usual dose is 50 to 60 IU per kg of body weight, given once every 7 days.
Slovenian: 12 let, bodo morda potrebni večji odmerki ali pogostejše injiciranje, običajni odmerek pa je od 50 do
English: Intravenous use, after reconstitution.
Slovenian: intravenska uporaba po rekonstituciji Pred uporabo preberite priloženo navodilo!
English: Remove the plastic flip-top cap from the ALPROLIX vial
Slovenian: Z viale z zdravilom ALPROLIX snemite plastično zaporko.
English: ALPROLIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU eftrenonacog alfa.
Slovenian: ALPROLIX 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. eftrenonakoga alfa (eftrenonacogum alfa).
English: ALPROLIX 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU eftrenonacog alfa.
Slovenian: ALPROLIX 3000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 3000 i.e. eftrenonakoga alfa (eftrenonacogum alfa).
English: Slowly depress the plunger rod to inject all the solvent into the ALPROLIX vial.
Slovenian: Nosilec za bat brizge počasi potiskajte, da injicirate celotno količino vehikla v vialo z zdravilom
English: How to store ALPROLIX
Slovenian: Shranjevanje zdravila ALPROLIX
English: ALPROLIX is administered by intravenous (IV) injection after dissolving the powder for injection with the solvent supplied in the pre-filled syringe.
Slovenian: injekcije potem, ko se prašek za injiciranje raztopi z vehiklom v napolnjeni injekcijski brizgi.
English: MRT (h) Vss (mL/kg) Time to 1% (days)2
Slovenian: MRT (h) Vss (ml/kg)
English: ALPROLIX 250 IU powder and solvent for solution for injection ALPROLIX 500 IU powder and solvent for solution for injection ALPROLIX 1000 IU powder and solvent for solution for injection ALPROLIX 2000 IU powder and solvent for solution for injection ALPROLIX 3000 IU powder and solvent for solution for injection eftrenonacog alfa recombinant coagulation factor IX, Fc fusion protein
Slovenian: ALPROLIX 250 i.e. prašek in vehikel za raztopino za injiciranje ALPROLIX 500 i.e. prašek in vehikel za raztopino za injiciranje ALPROLIX 1000 i.e. prašek in vehikel za raztopino za injiciranje ALPROLIX 2000 i.e. prašek in vehikel za raztopino za injiciranje ALPROLIX 3000 i.e. prašek in vehikel za raztopino za injiciranje eftrenonacogum alfa rekombinantni koagulacijski faktor IX, fuzijska beljakovina Fc
English: The solution should appear clear to slightly opalescent and colourless.
Slovenian: Videz raztopine mora biti bister do rahlo opalescenten in brezbarven.
English: ALPROLIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU eftrenonacog alfa.
Slovenian: ALPROLIX 1000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1000 i.e. eftrenonakoga alfa (eftrenonacogum alfa).
English: During the shelf-life, the product may be stored at room temperature (up to 30°C) for a single period not exceeding 6 months.
Slovenian: Zdravilo lahko v roku uporabnosti za eno samo obdobje, ki ne sme biti daljše od 6 mesecev, shranjujete pri sobni temperaturi (do 30 °C).
English: Slowly pull on the plunger rod to draw back all the solution through the vial adapter into the syringe.
Slovenian: Počasi vlecite za nosilec za bat brizge, da izvlečete vso raztopino skozi nastavek na viali v injekcijsko brizgo.
English: ALPROLIX 250 IU powder and solvent for solution for injection ALPROLIX 500 IU powder and solvent for solution for injection ALPROLIX 1000 IU powder and solvent for solution for injection ALPROLIX 2000 IU powder and solvent for solution for injection ALPROLIX 3000 IU powder and solvent for solution for injection
Slovenian: ALPROLIX 250 i.e. prašek in vehikel za raztopino za injiciranje ALPROLIX 500 i.e. prašek in vehikel za raztopino za injiciranje ALPROLIX 1000 i.e. prašek in vehikel za raztopino za injiciranje ALPROLIX 2000 i.e. prašek in vehikel za raztopino za injiciranje ALPROLIX 3000 i.e. prašek in vehikel za raztopino za injiciranje
English: Dose and duration of the substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Slovenian: Odmerjanje Odmerek zdravila in trajanje nadomestnega zdravljenja sta odvisna od stopnje pomanjkanja faktorja IX,
English: Repeat injection every 24 to 48 hours until pain and acute disability are resolved.
Slovenian: Injiciranje ponavljajte vsakih 24 do 48 ur ali več,
English: Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding
Slovenian: krvavitev v mišico ali krvavitev v ustni votlini
English: Uncommon side effects (may affect up to 1 in 100 people): dizziness, taste alteration, bad breath, feeling tired, pain at the injection site, rapid heartbeat, blood in the urine (haematuria), pain in your side (renal colic), low blood pressure, and decreased appetite.
Slovenian: slab zadah, občutek utrujenosti, bolečina na mestu injiciranja, hitro utripanje srca, kri v urinu (hematurija),
English: Turn the plunger rod firmly clockwise until it is securely seated in the syringe plunger.
Slovenian: Nosilec čvrsto obračajte v smeri urnega kazalca, da se varno usede v bat injekcijske brizge.
English: After reconstitution, each mL of solution for injection contains approximately 50 IU eftrenonacog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 50 i.e. eftrenonakoga alfa.
English: The median overall dose to treat a bleeding episode was 68.22 IU/kg (interquartile range,
Slovenian: Mediana celokupnega odmerka za zdravljenje epizode krvavitve je bila 68,22 i.e./kg (interkvartilni razpon 50,89-126,19).
English: After reconstitution, each mL of solution for injection contains approximately 400 IU eftrenonacog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 400 i.e. eftrenonakoga alfa.
English: Detach the syringe from the vial adapter by gently pulling and turning the vial counterclockwise.
Slovenian: Injekcijsko brizgo z nežnim vlečenjem in obračanjem viale v nasprotno smer urnega kazalca ločite od nastavka na viali.
English: B) 5 mL Solvent in pre-filled syringe C) 1 Plunger rod
Slovenian: A) 1 vialo s praškom B) 5 ml vehikla v napolnjeni injekcijski brizgi C) 1 nosilec za bat brizge D) 1 nastavek za vialo E) 1 infuzijski komplet F) 2 alkoholna zloženca G) 2 obliža
English: The calculation of the required dose of recombinant factor IX Fc is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 1% of normal activity (IU/dL).
Slovenian: Izračun potrebnega odmerka rekombinantnega faktorja IX Fc temelji na empirični ugotovitvi, da
English: After reconstitution, each mL of solution for injection contains approximately 600 IU eftrenonacog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 600 i.e. eftrenonakoga alfa.
English: After reconstitution, each mL of solution for injection contains approximately 200 IU eftrenonacog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 200 i.e. eftrenonakoga alfa.
English: Hypotension
Slovenian: Krvavitev
English: After reconstitution, each mL of solution for injection contains approximately 100 IU eftrenonacog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 100 i.e. eftrenonakoga alfa.
English: Nervous system disorders
Slovenian: Žilne bolezni hipotenzija občasni
English: Mannitol
Slovenian: ALPROLIX.
English: The prepared solution will be clear to slightly opalescent and colourless.
Slovenian: Pripravljena raztopina mora biti bistra do rahlo opalescentna (bisernata) in brezbarvna.
English: Intravenous use.
Slovenian: Navodilo za uporabo
English: L-histidine
Slovenian: (rFIXFc).
English: Powder: 250 IU eftrenonacog alfa (approx. 50 IU/mL after reconstitution), Powder: 500 IU eftrenonacog alfa (approx. 100 IU/mL after reconstitution) Powder: 1000 IU eftrenonacog alfa (approx. 200 IU/mL after reconstitution) Powder: 2000 IU eftrenonacog alfa (approx. 400 IU/mL after reconstitution) Powder: 3000 IU eftrenonacog alfa (approx. 600 IU/mL after reconstitution)
Slovenian: 200 i.e./ml po rekonstituciji) Prašek: 2000 i.e. eftrenonakoga alfa (pribl.
English: … or onto a small amount of food.
Slovenian: … ali na majhno količino hrane.
English: Avoid eye contact.
Slovenian: Preprečite stik z očmi.
English: No significant gender effect was seen.
Slovenian: Značilnih učinkov spola niso opazili.
English: The terminal elimination half-life (t1/2) ranged from 7.3 hours to 8.6 hours, with mean value 7.7 hours.
Slovenian: Končni eliminacijski razpolovni čas (t1/2) je bil v razponu od 7,3 ure do 8,6 ur, s povprečno vrednostjo 7,7 ur.
English: The CVMP agreed that the periodic safety update report (PSUR) cycle would be re-started at 6 months, 12 months and 24 months following authorisation of the extension, as detailed in the CVMP assessment report.
Slovenian: CVMP se je strinjal, da se cikel rednih posodobljenih poročil o varnosti zdravila (PSUR) ponovno začne izvajati 6 mesecev, 12 mesecev in 24 mesecev po odobritvi razširitve, kot je podrobno navedeno v poročilu o oceni CVMP.
English: The target SBP range is between 120 and 140 mmHg.
Slovenian: Ciljni razpon SBP je med 120 in 140 mm Hg.
English: See section “Contraindications”.
Slovenian: Glejte poglavje "Kontraindikacije".
English: The product is to be administered once daily directly into the mouth or with a small amount of food.
Slovenian: Zdravilo se daje neposredno v usta ali z majhno količino hrane enkrat na dan.
English: If the SBP increases over the course of the disease the daily dose may be increased again up to 2 mg/kg.
Slovenian: Če se SBP med potekom bolezni poveča, se lahko dnevni odmerek ponovno poveča do 2 mg/kg.
English: ATCvet code: QC09CA07
Slovenian: Oznaka ATC vet: QC09CA07.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri)
English: Date of first authorisation: Date of last renewal:
Slovenian: Datum pridobitve dovoljenja: Datum zadnjega podaljšanja dovoljenja:
English: PSURs:
Slovenian: PSUR:
English: Treatment of systemic hypertension in cats.
Slovenian: Zdravljenje sistemske hipertenzije pri mačkah.