FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal and hepatic impairment No dose adjustment is required in patients with renal or hepatic impairment (see section 5.2).
Slovenian: Okvara ledvic ali jeter Bolnikom z okvaro ledvic ali jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Primary endpoint Percent reduction in OCS from baseline (weeks 20-24)
Slovenian: Odstotno zmanjšanje PKS od izhodišča (20.
English: • Do not shake the syringe.
Slovenian: • Brizge ne stresajte.
English: The solution should be clear to opalescent, and colourless to pale yellow or pale brown, free of visible particles.
Slovenian: Raztopina mora biti bistra do opalescentna in brezbarvna do bledorumena ali svetlorjava, brez vidnih delcev.
English: • Dispose of the used pen and needle cap according to local requirements.
Slovenian: • Uporabljeni peresnik in pokrovček igle zavrzite v skladu z lokalnimi predpisi.
English: Each vial contains 100 mg mepolizumab.
Slovenian: Ena viala vsebuje 100 mg mepolizumaba.
English: • Do not rub your injection site.
Slovenian: • Mesta injiciranja ne drgnite.
English: Step-by-step instructions for use
Slovenian: Podrobna navodila za uporabo
English: No children had detectable anti-mepolizumab antibodies during the long-term phase of the study.
Slovenian: V dolgotrajni fazi študije ni imel noben otrok zaznanih protiteles proti mepolizumabu.
English: Placebo
Slovenian: s placebom)
English: The powder for solution for injection presentation is appropriate for administration to this population.
Slovenian: Za uporabo v tej populaciji je primerna oblika praška za raztopino za injiciranje.
English: Patients continued to receive their existing asthma medicine during the study with the exception of their OCS dose which was reduced every 4 weeks during the OCS reduction phase (Weeks 4-20), as long as asthma control was maintained.
Slovenian: PKS, ki so jim ga med obdobjem zmanjševanja PKS (4. do 20. teden) zmanjšali vsake 4 tedne, če je bila astma še vedno urejena.
English: Comprehensive instructions for subcutaneous administration of Nucala in a pre-filled pen or pre-filled syringe are provided at the end of the package leaflet.
Slovenian: Izčrpna navodila za subkutano injiciranje zdravila Nucala v napolnjenem injekcijskem peresniku ali napolnjeni injekcijski brizgi so navedena na koncu navodila za uporabo zdravila.
English: Solution for injection (injection) A clear to opalescent, colourless to pale yellow to pale brown solution
Slovenian: Raztopina za injiciranje (injekcija) Bistra do opalescentna, brezbarvna do bledo rumena ali bledo rjava raztopina.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v hrbtu pogosti
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (MULTIPACK ONLY WITHOUT BLUE BOX)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (LE ZA VEČKRATNO PAKIRANJE, BREZ MODREGA OKENCA)
English: Nucala is supplied as a 1 mL clear to opalescent, colourless to pale yellow to pale brown solution in a single use pre-filled syringe.
Slovenian: Zdravilo Nucala je na voljo kot 1 ml bistre do opalescentne, brezbarvne do bledo rumene ali bledo rjave raztopine v napolnjeni injekcijski brizgi za enkratno uporabo.
English: Check with your doctor if you think this applies to you.
Slovenian: Če menite, da to velja za vas, se posvetujte z zdravnikom.
English: You should also receive training on how to use the pre-filled pen.
Slovenian: Opraviti morate tudi usposabljanje za uporabo napolnjenega injekcijskega peresnika.
English: The Nucala pre-filled syringe can be removed from the refrigerator and kept in its unopened carton for up to 7 days at room temperature (up to 30°C), when protected from light.
Slovenian: Napolnjeni injekcijski peresnik zdravila Nucala je mogoče vzeti iz hladilnika in ga hraniti v njegovi neodprti škatli do 7 dni pri sobni temperaturi (do 30 °C), če je zaščiten pred svetlobo.
English: Also contains: sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, water for injections.
Slovenian: Pomožne snovi: saharoza, natrijev hidrogenfosfat heptahidrat, citronska kislina, monohidrat, polisorbat 80, dinatrijev edetat dihidrat in voda za injekcije.
English: Exacerbation rate per year Mepolizumab vs. placebo Rate ratio (95% CI)
Slovenian: Delež poslabšanj na leto Mepolizumab v primerjavi s placebom Razmerje deležev (95 % IZ)
English: Solution for injection in pre-filled syringe.
Slovenian: Raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Exacerbation rate per year Percent reduction Rate ratio (95% CI) p-value
Slovenian: Delež poslabšanj na leto Odstotno zmanjšanje Razmerje deležev (95 % IZ) Vrednost p
English: Nucala is available in a pack containing 1 pre-filled pen, or in a multipack comprised of 3 x 1 pre-filled pen.
Slovenian: Zdravilo Nucala je na voljo v pakiranju, ki vsebuje 1 napolnjen injekcijski peresnik, in v skupnem pakiranju, ki vsebuje 3 x 1 napolnjen injekcijski peresnik.
English: The safety profile of mepolizumab in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies was similar to that observed in the placebo-controlled studies.
Slovenian: Varnostne značilnosti mepoluzimaba pri bolnikih s težko trdovratno eozinofilno astmo (n=998) , ki so v odprtih podaljšanih študijah prejemali zdravljenje mediano 2,8 leta (razpon: od 4 tedne do 4,5 leta), so bile podobne tistim, ki so jih opažali v s placebom kontroliranih študijah.
English: Table 3: Combined analysis of the rate of clinically significant exacerbations by baseline blood eosinophil count in patients with severe refractory eosinophilic asthma
Slovenian: Preglednica 3: Kombinirana analiza deleža klinično pomembnih poslabšanj pri bolnikih s težko trdovratno eozinofilno astmo glede na izhodiščno število eozinofilcev v krvi mepolizumab 75 mg i.v./100 mg s.c.
English: Do not rub your injection site.
Slovenian: Mesta injiciranja ne drgnite.
English: Multipack: 3 pre-filled syringes (3 packs of 1 pre-filled syringe).
Slovenian: Večkratno pakiranje: 3 napolnjeni injekcijski peresniki (3 pakiranja po 1 napolnjen injekcijski peresnik)
English: PARTICULARS TO APPEAR ON OUTER PACKAGING MULTIPACK CARTON (3 PACKS OF 1 VIAL - WITH BLUE BOX)
Slovenian: ŠKATLA Z VEČKRATNIM PAKIRANJEM (3 PAKIRANJA Z 1 VIALO - Z MODRIM OKENCEM)
English: A total of 896 adults and 19 adolescent subjects with severe refractory eosinophilic asthma received either a subcutaneous or an intravenous dose of mepolizumab during three placebo-controlled clinical studies of 24 to 52 weeks duration.
Slovenian: 19 mladostnikov s težko trdovratno eozinofilno astmo prejemalo mepolizumab subkutano ali intravensko.
English: Nucala 100 mg solution for injection in pre-filled pen Nucala 100 mg solution for injection in pre-filled syringe
Slovenian: Nucala 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nucala 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: The long-term efficacy profile of Nucala in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies MEA115666, MEA115661 and 201312 was generally consistent with the 3 placebo-controlled studies.
Slovenian: ki so v odprtih podaljšanih študijah MEA115666, MEA115661 in 201312 prejemali zdravljenje mediano 2,8 leta (razpon: od 4 tedne do 4,5 leta), se je na splošno skladal s tistim v 3 s placebom kontroliranih študijah.
English: Nucala is supplied as a 1 mL clear to opalescent, colourless to pale yellow to pale brown solution in a single use pre-filled pen.
Slovenian: Zdravilo Nucala je na voljo kot 1 ml bistre do opalescentne, brezbarvne do bledo rumene ali bledo rjave raztopine v napolnjenem injekcijskem peresniku za enkratno uporabo.
English: GlaxoSmithKline Manufacturing S.P.A. Strada Provinciale Asolana No. 90, Torrile, 43056, Parma, Italy
Slovenian: Strada Provinciale Asolana N. 90, Torrile, 43056,
English: • Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe,
English: 1 pre-filled syringe.
Slovenian: 1 napolnjena injekcijska brizga.
English: Nucala 100 mg solution for injection in pre-filled syringe Each 1 ml pre-filled syringe contains 100 mg of mepolizumab.
Slovenian: Nucala 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 1 ml napolnjena injekcijska brizga vsebuje 100 mg mepolizumaba.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora zamašenost nosu pogosti
English: No dose adjustment is required in patients with renal or hepatic impairment (see section 5.2).
Slovenian: Bolnikom z okvaro ledvic ali jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Seek medical attention immediately if you think you (or your child) may be having a reaction.
Slovenian: Če sumite, da imate (vi ali vaš otrok) takšno reakcijo, nemudoma poiščite zdravniško pomoč.
English: Solution for injection in pre-filled pen Multipack: 3 pre-filled pens (3 packs of 1 pre-filled pen).
Slovenian: Raztopina za injiciranje v napolnjeni injekcijski brizgi Večkratno pakiranje: 3 napolnjene injekcijske brizge (3 pakiranja po 1 napolnjeno injekcijsko brizgo)
English: Anti-mepolizumab antibodies did not discernibly impact the pharmacokinetics and pharmacodynamics of mepolizumab in the majority of patients and there was no evidence of a correlation between antibody titres and change in blood eosinophil level.
Slovenian: Protitelesa proti mepolizumabu pri večini bolnikov niso opazno vplivala na farmakokinetiko in farmakodinamiko mepolizumaba.
English: Headache
Slovenian: Zamašek
English: MEA115588 was a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study which evaluated the efficacy and safety of mepolizumab as add-on therapy in 576 patients with severe refractory eosinophilic asthma defined as peripheral blood eosinophils greater than or equal to 150 cells/μL at initiation of treatment or greater than or equal to 300 cells/μL within the past 12 months.
Slovenian: Študija MEA115588 je bila randomizirana, dvojno slepa, s placebom kontrolirana multicentrična študija vzporednih skupin za oceno učinkovitosti in varnosti mepolizumaba kot dodatnega zdravljenja pri
English: • If someone else gives you the injection, they can also use your upper arm. Do not inject where your skin is bruised, tender, red or hard.
Slovenian: • Če vam zdravilo injicira nekdo drug, lahko uporabi tudi vaš nadlaket.
English: Mepolizumab crosses the placental barrier in monkeys.
Slovenian: Pri opicah mepolizumab prehaja skozi placento.
English: Nucala 100 mg powder for solution for injection
Slovenian: Nucala 100 mg prašek za raztopino za injiciranje
English: Excipients: Sucrose, sodium phosphate dibasic heptahydrate and polysorbate 80
Slovenian: Pomožne snovi: saharoza, natrijev hidrogenfosfat heptahidrat in polisorbat 80.
English: Once reconstituted, Nucala will contain a concentration of 100 mg/mL mepolizumab.
Slovenian: Po rekonstituciji bo koncentracija mepolizumaba v zdravilu Nucala 100 mg/ml.
English: • Peel back the film cover from the tray.
Slovenian: • Odlepite prekrivno folijo z embalaže.
English: Nucala 100 mg powder for solution for injection mepolizumab
Slovenian: Nucala 100 mg prašek za raztopino za injiciranje mepolizumab
English: Multipack comprising 3 (3 packs of 1) pre-filled syringe
Slovenian: Večkratno pakiranje s 3 (3 pakiranja po 1) napolnjenimi injekcijskimi peresniki
English: Pull off the needle cap
Slovenian: Potegnite pokrovček igle
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - NAPOLNJENA INJEKCIJSKA BRIZGA
English: Asthma exacerabations
Slovenian: Poslabšanja astme
English: The recommended dose for adults and adolescents is 100 mg. You will be given 1 injection every four weeks.
Slovenian: Priporočeni odmerek za odrasle in mladostnike je 100 mg.
English: Package leaflet: Information for the user Nucala 100 mg powder for solution for injection mepolizumab This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Nucala 100 mg prašek za raztopino za injiciranje mepolizumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING INTERMEDIATE CARTON - PRE-FILLED SYRINGE MULTIPACK (WITHOUT BLUE BOX)
Slovenian: VMESNA ŠKATLA - VEČKRATNO PAKIRANJE NAPOLNJENE INJEKCIJSKE BRIZGE (BREZ MODREGA OKENCA)
English: If you are not sure what to do, ask your doctor, pharmacist or nurse.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Some people get asthma-related side effects, or their asthma may become worse, during treatment with Nucala.
Slovenian: Nekaterim bolnikom se lahko med zdravljenjem z zdravilom Nucala pojavijo z astmo povezani neželeni učinki ali se jim astma poslabša.
English: Stopper
Slovenian: minut
English: Safely, throw the pre-filled syringe away if it has been kept out of the refrigerator for more than 7 days.
Slovenian: Če je bila napolnjena injekcijska brizga shranjena izven hladilnika več kot 7 dni, jo varno zavrzite.
English: Do not let the needle touch any surface.
Slovenian: Pazite, da se z iglo ničesar ne dotaknete.
English: How to store Nucala
Slovenian: Shranjevanje zdravila Nucala
English: • Nucala pre-filled syringe
Slovenian: • napolnjeno injekcijsko brizgo zdravila Nucala
English: Needle guard
Slovenian: Ščitnik igle
English: Dispose of the remaining solution.
Slovenian: Preostanek raztopine zavrzite.
English: The pack should be discarded if not administered within 8 hours.
Slovenian: Če zdravilo ni uporabljeno v 8 urah, je pakiranje treba zavreči.
English: After reconstitution, each ml of solution contains 100 mg mepolizumab.
Slovenian: Po rekonstituciji vsebuje 1 ml raztopine 100 mg mepolizumaba.
English: Rate ratio (95% CI) p-value
Slovenian: Razmerje obetov (95 % IZ) Vrednost p
English: Step by step instructions for using the pre-filled syringe
Slovenian: Navodila za uporabo napolnjene injekcijske brizge korak za korakom
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL - FOR PRE-FILLED SYRINGE MULTIPACK (WITH BLUE BOX)
Slovenian: NALEPKA ZA NAPOLNJEN INJEKCIJSKI PERESNIK ZA VEČKRATNO PAKIRANJE (Z MODRIM OKENCEM)
English: Package leaflet: Information for the user Nucala 100 mg solution for injection in pre-filled syringe mepolizumab This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Nucala 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku mepolizumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Nucala 100 mg solution for injection in pre-filled syringe
Slovenian: Zdravilo Nucala 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Median % reduction in daily OCS dose from baseline (95% CI) Median difference (95% CI) p-value
Slovenian: Mediani % zmanjšanja dnevnega odmerka PKS od izhodišča (95 % IZ)
English: Take the syringe out of the tray
Slovenian: Vzemite brizgo iz embalaže
English: Discard if left out of the refrigerator for more than 7 days.
Slovenian: Če je bil izven hladilnika več kot 7 dni, ga zavrzite.
English: Nucala pre-filled syringe is for use under the skin only (subcutaneous).
Slovenian: Zdravilo Nucala napolnjena injekcijska brizga je namenjeno le za podkožno (subkutano) uporabo.
English: White plunge
Slovenian: Bel bat
English: Percent reduction Rate ratio (95% CI) p-value
Slovenian: Razmerje deležev (95 % IZ) Vrednost p
English: Nucala 100 mg solution for injection in pre-filled syringe mepolizumab
Slovenian: Nucala 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku mepolizumab
English: Store in the original container to protect from light.
Slovenian: Brizgo shranjujte v originalnem vsebniku za zagotovitev zaščite pred svetlobo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - PRE-FILLED PEN
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - NAPOLNJEN INJEKCIJSKI PERESNIK
English: Take the pen out of the tray
Slovenian: Vzemite peresnik iz embalaže
English: In children aged 6 to 11 years old with severe refractory eosinophilic asthma administered mepolizumab subcutaneously every 4 weeks for 52 weeks, blood eosinophils were reduced from a geometric mean count at baseline to week 52 of 306 (n=16) to 48 (n=15) following 40 mg (for a weight < 40kg) and 331 to
Slovenian: Pri otrocih, starih od 6 do 11 let, s težko trdovratno eozinofilno astmo, ki so prejemali mepolizumab subkutano na 4 tedne 52 tednov, se je število eozinofilcev v krvi z izhodiščne geometrične sredine do
English: Safely, throw the pen away if it has been kept out of the refrigerator for more than 7 days.
Slovenian: Če je bil napolnjen injekcijski peresnik shranjen izven hladilnika več kot 7 dni, ga varno zavrzite.
English: Needle cap (needle inside)
Slovenian: (igla znotraj)
English: Odds ratio (95% CI) p-value
Slovenian: Mediana razlika (95 % IZ) Vrednost p
English: Take out your pre-filled syringe
Slovenian: Vzemite napolnjeno injekcijsko brizgo ven
English: Reduction of exacerbation rate by baseline blood eosinophil count
Slovenian: Zmanjšanje deležev poslabšanj glede na izhodiščno število eozinofilcev
English: Store syringe in the original carton in order to protect from light.
Slovenian: Peresnik shranjujte v originalnem vsebniku za zagotovitev zaščite pred svetlobo.
English: Solution for injection in pre-filled pen.
Slovenian: Raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Each 1 ml pre-filled syringe contains 100 mg mepolizumab.
Slovenian: En 1 ml napolnjen injekcijski peresnik vsebuje 100 mg mepolizumaba.
English: Make sure you have within reach:
Slovenian: Preverite, ali imate pri roki:
English: Nucala pre-filled pen is for use under the skin only (subcutaneous).
Slovenian: Zdravilo Nucala napolnjen injekcijski peresnik je namenjen le za podkožno (subkutano) uporabo.
English: Each 1 mL pre-filled syringe contains 100 mg of mepolizumab.
Slovenian: En 1-ml napolnjene injekcijske brizge vsebuje 100 mg mepolizumaba.
English: Nucala 100 mg solution for injection in pre-filled pen
Slovenian: Zdravilo Nucala 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Store in the original package in order to protect from light.
Slovenian: Shranjujte v originalnem vsebniku za zagotovitev zaščite pred svetlobo.
English: Hepatic impairment
Slovenian: Bolezni živčevja glavobol zelo pogosti
English: Yellow needle guard (needle inside)
Slovenian: Rumeni ščitnik igle
English: Know your pre-filled syringe
Slovenian: Seznanite se s svojo napolnjeno injekcijsko brizgo
English: {text}
Slovenian: {besedilo}
English: Timetable for the implementation of this position
Slovenian: Časovnica za uveljavitev tega stališča
English: <Summary of Product Characteristics>
Slovenian: <Povzetek glavnih značilnosti zdravila>
English: Adoption of CMDh position: {Month Year} CMDh meeting
Slovenian: Sprejetje stališča skupine CMDh: Zasedanje skupine CMDh {mesec leto}
English: <Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through)>
Slovenian: <Spremembe, ki jih je treba vključiti v ustrezna poglavja informacij o zdravilu (novo besedilo je podčrtano in označeno krepko, izbrisano besedilo je prečrtano)>
English: Annex <III> <IV>
Slovenian: Priloga <III> <IV>
English: To the extent that additional medicinal products containing {active substance(s) as EURD list entry} are currently authorised in the EU or are subject to future authorisation procedures in the EU, the CMDh recommends that the concerned Member States and applicant/marketing authorisation holders take due consideration of this CMDh position.
Slovenian: Če so dovoljenje za promet v EU pridobila tudi druga zdravila, ki vsebujejo {učinkovina(-e), kot je (so) zapisana(-e) na seznamu EURD}, ali če bodo taka zdravila v prihodnje predmet postopkov za pridobitev dovoljenja za promet v EU, skupina CMDh priporoča, da zadevne države članice in predlagatelji/imetniki dovoljenja za promet s temi zdravili ustrezno upoštevajo to stališče.
English: Transmission to National Competent Authorities of the translations of the annexes to the position: {DD/MM/YYYY}
Slovenian: Posredovanje prevodov prilog k stališču pristojnim nacionalnim organom: {DD/MM/LLLL}
English: On the basis of the scientific conclusions for {active substance(s) as EURD list entry} the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) containing {active substance(s) as EURD list entry} is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za {učinkovina(-e), kot je (so) zapisana(-e) na seznamu EURD} skupina CMDh meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) {učinkovina(-e), kot je (so) zapisana(-e) na seznamu EURD} nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: The CMDh reaches the position that the marketing authorisation(s) of products in the scope of this single PSUR assessment should be varied.
Slovenian: Skupina CMDh je sprejela stališče, da je potrebna sprememba dovoljenja (dovoljenj) za promet z zdravili, ki so zajeta v to enotno oceno PSUR.
English: Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder): {DD/MM/YYYY}
Slovenian: Uveljavitev stališča v državah članicah (predložitev spremembe s strani imetnika dovoljenja za promet z zdravilom): {DD/MM/LLLL}
English: <Annex III>
Slovenian: <Priloga III>
English: Taking into account the PRAC Assessment Report on the PSUR(s) for {active substance(s) as EURD list entry}, the scientific conclusions are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni redno posodobljenih poročil o varnosti zdravila (PSUR) za {učinkovina(-e), kot je (so) zapisana(-e) na seznamu EURD} so bili sprejeti naslednji znanstveni zaključki:
English: Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: Amendments to the product information of the nationally authorised medicinal product(s)
Slovenian: Spremembe informacij o zdravilu za zdravila, ki so pridobila dovoljenje(-a) za promet po nacionalnem postopku
English: <Conditions to the Marketing Authorisation(s)>
Slovenian: <Pogoji dovoljenja (dovoljenj) za promet z zdravilom>
English: <Package Leaflet>
Slovenian: <Navodilo za uporabo>
English: 8000 units (40 mg)
Slovenian: 8.000 enot (40 mg)
English: 10000 units (50 mg) Powder and solvent for solution for injection
Slovenian: 10.000 enot (50 mg) prašek in vehikel za raztopino za injiciranje
English: These effects were transitory and usually resolved without any treatment within 5 to 15 days, but could persist up to 49 days.
Slovenian: Učinki so bili prehodni in so izveneli brez zdravljenja znotraj 5 do 15 dni, vendar lahko trajajo tudi do 49 dni.
English: Meat and offal: 56 days.
Slovenian: Meso in organi: 56 dni
English: Bovine 200
Slovenian: Govedo 200
English: For the full list of excipients, see section 6.1
Slovenian: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Use only according to the benefit-risk assessment by the responsible veterinarian.
Slovenian: Uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
English: However, a clear antipyretic effect has been demonstrated in the first 48 hours after administration.
Slovenian: Je pa bil ugotovljen očiten antipiretični učinek v prvih 48 urah po dajanju.
English: In the absence of safety data it is not recommended to use the product in calves less than 4 weeks old.
Slovenian: Zaradi pomanjkanja podatkov o varnosti ni priporočljivo uporabiti zdravila pri teletih mlajših od 4 tednov.
English: Otherwise, the use of a multiple-dose syringe is recommended.
Slovenian: Drugače se priporoča uporaba večodmerne brizge.