natgillin/translations-raw huggingface dataset:
What you need to know before you are given ZINPLAVA 3.
Kaj morate vedeti, preden boste prejeli zdravilo ZINPLAVA 3.
Excipients: Citric acid monohydrate, diethylenetriaminepentaacetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, water for injections, sodium hydroxide.
Pomožne snovi: citronska kislina monohidrat, dietilentriaminpentaocetna kislina, polisorbat 80, natrijev klorid, natrijev citrat dihidrat, voda za injekcije, natrijev hidroksid.
The effect of renal impairment on the pharmacokinetics of bezlotoxumab was evaluated in patients with mild (eGFR 60 to < 90 mL/min/1.73 m 2), moderate (eGFR 30 to < 60 mL/min/1.73 m 2), or severe
Vpliv okvare ledvic na farmakokinetiko bezlotoksumaba so ocenili pri bolnikih z blago (eGFR 60 do < 90 ml/min/1,73 m 2), zmerno (eGFR 30 do < 60 ml/min/1,73 m 2) ali hudo
ZINPLAVA is not a treatment for CDI and has no effect on the current CDI episode.
Zdravilo ZINPLAVA ni zdravilo za CDI in nima vpliva na trenutno epizodo CDI.
Solution for infusion: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or 16 hours at room temperature (at or below 25°C).
Raztopina za infundiranje: Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi od 2 °C do 8 °C ali 16 ur pri sobni temperaturi (25 °C ali manj).
ZINPLAVA is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI (see sections 4.2, 4.4 and 5.1).
Zdravilo ZINPLAVA je indicirano za preprečevanje ponovitve okužbe z bakterijo Clostridium difficile (CDI - Clostridium difficile infection) pri odraslih z visokim tveganjem za ponovitev CDI (glejte poglavja 4.2, 4.4 in 5.1).
The following side effects have been reported in clinical trials:
V kliničnih preskušanjih so poročali o naslednjih neželenih učinkih:
Bezlotoxumab-mediated drug-drug interactions are unlikely as the target of bezlotoxumab is an exogenous toxin.
Medsebojno delovanje z zdravili, povzročeno zaradi bezlotoksumaba, je malo verjetno, saj je tarča bezlotoksumaba eksogeni toksin.
What ZINPLAVA is and what it is used for
Kaj je zdravilo ZINPLAVA in za kaj ga uporabljamo
There are limited data from the use of bezlotoxumab in pregnant women.
Podatkov o uporabi bezlotoksumaba pri nosečnicah je malo.
In clinical trials, patients with CDI were only administered a single dose of ZINPLAVA (see section 5.1).
V kliničnih preskušanjih so bolniki s CDI prejeli samo enkraten odmerek zdravila ZINPLAVA (glejte poglavje 5.1).
The day of the infusion of ZINPLAVA or placebo ranged from prior to the start of antibacterial therapy up to day 14 of treatment, with a median on day 3.
Bolniki so zdravilo ZINPLAVA oziroma placebo prejeli v obdobju od dneva pred začetkom protibakterijskega zdravljenja do 14. dneva zdravljenja, z mediano na 3. dan zdravljenja.
Bezlotoxumab is eliminated from the body primarily by protein degradation.
Bezlotoksumab se iz telesa izloči predvsem z beljakovinsko razgradnjo.
Bezlotoxumab prevents CDI recurrence by providing passive immunity against toxin produced by the outgrowth of persistent or newly-acquired C. difficile spores.
Bezlotoksumab prepreči ponovitev CDI tako, da zagotovi pasivno imunost proti toksinu, ki nastaja zaradi razrasta perzistentnih ali novopridobljenih spor bakterije C. difficile.
Bezlotoxumab is catabolized through protein degradation processes; metabolism does not contribute to its clearance.
Katabolizem bezlotoksumaba poteka s procesi razgradnje beljakovin; presnova ne pripomore k njegovemu očistku.
Infusion specific adverse reactions reported in ≥ 0.5 % of subjects receiving ZINPLAVA and at a frequency greater than placebo were nausea (3 %), fatigue (1 %), pyrexia (1 %), dizziness (1 %), headache (2 %), dyspnoea (1 %) and hypertension (1 %).
Neželeni učinki, specifični za infuzijo in poročani pri ≥ 0,5 % preiskovancev, zdravljenih z zdravilom ZINPLAVA, in s pogostnostjo, ki je bila večja kot pri placebu, so bili navzea (3 %), utrujenost (1 %), zvišana telesna temperatura (1 %), omotica (1 %), glavobol (2 %), dispneja (1 %) in hipertenzija (1 %).
Table 1 presents the adverse reactions reported within 4 weeks of infusion in ZINPLAVA-treated patients and listed by System Organ Class.
V preglednici 1 so navedeni neželeni učinki, o katerih so poročali v 4 tednih po infundiranju pri bolnikih, zdravljenih z zdravilom ZINPLAVA; navedeni so po organskih sistemih.
ZINPLAVA should be administered during the course of antibacterial therapy for CDI (see sections 4.4 and 5.1).
Zdravilo ZINPLAVA je treba uporabiti tekom protibakterijskega zdravljenja CDI (glejte poglavji 4.4 in 5.1).
The diluted solution of ZINPLAVA may be stored either at room temperature for up to 16 hours or under refrigeration at 2 °C to 8 °C for up to 24 hours.
Razredčeno raztopino zdravila ZINPLAVA je mogoče shranjevati bodisi pri sobni temperaturi do 16 ur ali v hladilniku (od 2 °C do 8 °C) do 24 ur.
(eGFR < 15 mL/min/1.73 m 2), as compared to patients demonstrating normal (eGFR
(eGFR < 15 ml/min/1,73 m 2) v primerjavi z bolniki z normalnim delovanjem ledvic
The experience with ZINPLAVA in patients is limited to a single CDI episode and single administration (see section 4.4).
Izkušnje z uporabo zdravila ZINPLAVA pri bolnikih so omejene na enkratno epizodo CDI in enkratno uporabo zdravila (glejte poglavje 4.4).
The effect of hepatic impairment on the pharmacokinetics of bezlotoxumab was evaluated in patients with hepatic impairment (defined as having two or more of the following: [1] albumin ≤ 3.1 g/dL; [2] ALT ≥ 2X ULN; [3] total bilirubin ≥ 1.3X ULN; or [4] mild, moderate or severe liver disease as reported by the Charlson Co-morbidity Index), as compared to patients with normal hepatic function.
Vpliv okvare jeter na farmakokinetiko bezlotoksumaba so ocenili pri bolnikih z okvaro jeter (opredeljeni kot tisti, ki so imeli dvoje ali več od naslednjega: [1] albumin ≤ 3,1 g/dl, [2] ALT ≥ 2x ZMN, [3] celokupni bilirubin ≥ 1,3x ZMN ali [4] blago, zmerno ali hudo bolezen jeter po Charlsonovem indeksu sočasnih bolezni) v primerjavi z bolniki z normalnim delovanjem jeter.
You should not be given ZINPLAVA if:
Zdravila ZINPLAVA ne smete prejeti:
A single infusion of ZINPLAVA or placebo was administered prior to completion of antibacterial therapy and patients were followed for 12 weeks following the infusion.
Bolniki so pred zaključkom protibakterijskega zdravljenja prejeli eno infuzijo zdravila ZINPLAVA ali placeba; bolnike so spremljali 12 tednov po infuziji.
Bezlotoxumab is a human monoclonal antitoxin antibody that binds with high affinity to C. difficile toxin B and neutralizes its activity.
Bezlotoksumab je humano monoklonsko protitelo proti toksinom, ki se z veliko afiniteto veže na toksin B bakterije C. difficile in nevtralizira njegovo delovanje.
• Administer the diluted solution for infusion intravenously over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
• Razredčeno raztopino za infundiranje aplicirajte intravensko v 60 minutah; uporabite sterilen, nepirogen 0,2 do 5 µm linijski ali dodatni filter, ki minimalno veže beljakovine.
These adverse reactions were reported at a similar frequency in placebo treated patients compared with ZINPLAVA treated patients.
O teh neželenih učinkih so s podobno pogostnostjo poročali pri bolnikih, ki so prejemali placebo, in pri tistih, ki so bili zdravljeni z zdravilom ZINPLAVA.
What you need to know before you are given ZINPLAVA
Kaj morate vedeti, preden boste prejeli zdravilo ZINPLAVA
The number of patients completing the studies and included in the full analysis set (FAS) was 781 in the ZINPLAVA group versus 773 in the placebo group.
781 bolnikov, ki so zaključili študijo in bili vključeni v celotni nabor za analizo, je bilo v skupini z zdravilom ZINPLAVA in 773 v skupini s placebom.
Bezlotoxumab has no or negligible influence on the ability to drive and use machines.
Bezlotoksumab nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Bezlotoxumab exposures in healthy subjects increased in an approximately dose proportional manner across the 0.3 to 20 mg/kg dose range.
Pri zdravih preiskovancih se je izpostavljenost bezlotoksumabu v razponu odmerkov od 0,3 do 20 mg/kg povečevala približno sorazmerno odmerku.
Immunogenicity of ZINPLAVA was evaluated using an electrochemiluminescence (ECL) assay in MODIFY I and MODIFY II.
Imunogenost zdravila ZINPLAVA so v študijah MODIFY I in MODIFY II ocenili z elektrokemiluminiscenčno (ECL) metodo.
Although ZINPLAVA is intended for single dose administration, the immunogenicity of bezlotoxumab following a second administration of 10 mg/kg, 12 weeks after the first dose, was assessed in 29 healthy subjects.
Čeprav je zdravilo ZINPLAVA namenjeno za uporabo v enkratnem odmerku, so pri 29 zdravih preiskovancih ocenili imunogenost bezlotoksumaba po drugem odmerku 10 mg/kg, uporabljenem 12 tednov po prvem odmerku.
(eGFR 15 to < 30 mL/min/1.73 m 2) renal impairment, or with end stage renal disease
(eGFR 15 do < 30 ml/min/1,73 m 2) okvaro ledvic ali s končno odpovedjo ledvic
• Do not freeze the diluted solution.
• Razredčene raztopine ne smete zamrzniti.
Infected with 027 ribotype n = Number of patients within subgroup that met the criteria for endpoint m = Number of patients within subgroup
Vrednost p n = Število bolnikov v analizni populaciji, ki je izpolnjevala merila za opazovani dogodek N = Število bolnikov, vključenih v analizno populacijo
Driving and using machines ZINPLAVA has no or very little effect on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo ZINPLAVA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
- The other ingredients are citric acid monohydrate (E330), diethylenetriaminepentaacetic acid, polysorbate 80 (E433), sodium chloride, sodium citrate dihydrate (E331), water for injections, and sodium hydroxide (E524) (for pH adjustment).
- Druge sestavine zdravila so citronska kislina monohidrat (E330), dietilentriaminpentaocetna kislina, polisorbat 80 (E433), natrijev klorid, natrijev citrat dihidrat (E331), voda za injekcije in natrijev hidroksid (E524) (za prilagoditev pH).
ZINPLAVA 25 mg/mL concentrate for solution for infusion
ZINPLAVA 25 mg/ml koncentrat za raztopino za infundiranje
There is no clinical experience with overdosage of ZINPLAVA.
Kliničnih izkušenj s prevelikim odmerjanjem zdravila ZINPLAVA ni.
After a single IV dose of 10 mg/kg bezlotoxumab, mean AUC(0-∞) and Cmax were 53,000 mcg.h/mL and 185 mcg/mL, respectively, in patients with CDI.
Po enkratnem intravenskem odmerku 10 mg/kg bezlotoksumaba je bila pri bolnikih s CDI povprečna AUC(0-∞) 53.000 µg.h/ml in povprečna Cmax 185 µg/ml.
ZINPLAVA is given with the antibiotic therapy you are taking for CDI.
Zdravilo ZINPLAVA se daje skupaj z antibiotičnim zdravljenjem, ki ga jemljete za CDI.
Adult patients had a confirmed diagnosis of CDI, which was defined as diarrhoea (passage of 3 or more loose bowel movements as defined in the Bristol stool chart as types 5 through 7 in 24 or fewer hours) and a positive stool test for toxigenic C. difficile from a stool sample collected no more than 7 days before study entry.
Diagnoza CDI je bila opredeljena kot diareja (3 ali več iztrebljanj mehkega blata tipa 5 do 7 po Bristolski lestvici blata v 24 urah ali manj) skupaj s pozitivnim fekalnim testom za toksigeno bakterijo C. difficile v vzorcu blata, odvzetem ne več kot 7 dni pred vključitvijo v študijo.
Overall, 10 % of subjects in the ZINPLAVA group experienced one or more infusion specific adverse reactions on the day of, or the day after, the infusion compared to 8 % in the placebo group.
Skupno je imelo na dan infundiranja zdravila ali dan pozneje enega ali več za infuzijo specifičnih neželenih učinkov 10 % preiskovancev v skupini z zdravilom ZINPLAVA in 8 % preiskovancev v skupini s placebom.
There was no binding of bezlotoxumab to reproductive tissue in tissue cross reactivity studies, and no notable effects in the male and female reproductive organs in repeat dose toxicity studies in mice (see section 5.3).
Študije tkivne navzkrižne reaktivnosti niso pokazale vezave bezlotoksumaba na reproduktivna tkiva, v študijah toksičnosti ponavljajočih odmerkov pri miših pa niso zaznali opaznih učinkov na reproduktivne organe samcev in samic (glejte poglavje 5.3).
Type I glass vial containing 40 mL solution, with a chlorobutyl stopper, and a flip-off cap seal.
Viala iz stekla tipa I, s 40 ml raztopine, s klorbutilnim zamaškom in zaporko s snemljivim pokrovčkom.
What ZINPLAVA looks like and contents of the pack The concentrate for solution for infusion is a clear to moderately opalescent, colourless to pale yellow liquid.
Izgled zdravila ZINPLAVA in vsebina pakiranja Koncentrat za raztopino za infundiranje je bistra do zmerno opalescentna, brezbarvna do bledorumena raztopina.
Bezlotoxumab is dosed via the IV route and therefore is immediately and completely bioavailable.
Bezlotoksumab se uporablja intravensko, zato je njegova biološka uporabnost takojšnja in popolna.
How ZINPLAVA works
Kako deluje zdravilo ZINPLAVA
ZINPLAVA should be administered during the course of antibacterial therapy for CDI.
Zdravilo ZINPLAVA je treba uporabiti tekom protibakterijskega zdravljenja CDI.
Nausea, diarrhoea
Bolezni prebavil pogosti navzea, diareja
There were no notable effects in the male and female reproductive organs in mice based on repeat dose toxicity studies and no binding to reproductive tissues was observed in tissue cross-reactivity studies.
V študijah toksičnosti ponavljajočih se odmerkov niso ugotovili opaznih učinkov na reproduktivne organe samcev in samic, v študijah tkivne navzkrižne reaktivnosti pa niso ugotovili vezave na reproduktivna tkiva.
If refrigerated, allow the IV bag to come to room temperature prior to use.
Če je zdravilo shranjeno v hladilniku, pred uporabo pustite, da se intravenska vrečka ogreje na sobno temperaturo.
It binds to C. difficile toxin B.
Bezlotoksumab se veže na toksin B bakterije C. difficile.
No clinical data are available on the possible effects of bezlotoxumab on fertility.
Kliničnih podatkov o možnih učinkih bezlotoksumaba na plodnost ni na voljo.
There are no data on repeated administration of bezlotoxumab in patients with CDI.
Podatkov o ponavljajoči se uporabi bezlotoksumaba pri bolnikih s CDI ni.
United States
ZDA
• If the diluted solution is refrigerated, allow the IV bag to come to room temperature prior to use.
• Če je razredčena raztopina shranjena v hladilniku, pred uporabo pustite, da se intravenska vrečka ogreje na sobno temperaturo.
Animal reproduction or developmental toxicity studies have not been conducted with bezlotoxumab.
Z bezlotoksumabom niso izvedli študij reproduktivne ali razvojne toksičnosti na živalih.
There is no experience with repeat administration of ZINPLAVA in patients with CDI.
Izkušenj s ponavljajočo uporabo zdravila ZINPLAVA pri bolnikih s CDI ni.
ZINPLAVA 25 mg/mL concentrate for solution for infusion bezlotoxumab
ZINPLAVA 25 mg/ml koncentrat za raztopino za infundiranje bezlotoksumab
Elderly No dose adjustment is necessary in patients ≥ 65 years of age (see section 5.2).
Starejši Pri bolnikih, starih ≥ 65 let, prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
Serious adverse reactions
Resni neželeni učinki
Table 1: Adverse Reactions with ZINPLAVA MedDRA System Organ Class
Preglednica 1: Neželeni učinki zdravila ZINPLAVA
Do not use the vial if the solution is discoloured or contains visible particles.
Če je raztopina spremenjene barve ali vsebuje vidne delce, viale ne uporabite.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
Placebo with SoC Percent (n/N)
Placebo s SoC Odstotek (n/N)
• If you are breast-feeding or are planning to breast-feed, check with your doctor first.
• Če dojite ali nameravate dojiti, se prej posvetujte z zdravnikom.
Infected with a hypervirulent strain
Okužba s hipervirulentnim sevom Okužba z ribotipom 027
ZINPLAVA has no effect on the CDI you have now.
Zdravilo ZINPLAVA nima vpliva na epizodo CDI, ki je trenutno prisotna.
p-value n = Number of patients in the analysis population meeting the criteria for endpoint N = Number of patients included in the analysis population Full Analysis Set = a subset of all randomised patients with exclusions for: (i) did not receive infusion of study medication, (ii) did not have a positive local stool test for toxigenic C. difficile; (iii) did not receive protocol defined standard of care therapy within a 1 day window of the infusion; (iiii) GCP non-compliance SoC = Standard of Care antibacterial (metronidazole or vancomycin or fidaxomicin) One sided p-value based on the Miettinen and Nurminen method stratified by protocol (MODIFY I and MODIFY II), SoC antibacterial (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)
Celotni nabor za analizo = podnabor vseh randomiziranih bolnikov, izključujoč: (i) tiste, ki niso prejeli infuzije raziskovanega zdravila, (ii) tiste, ki niso imeli pozitivnega lokalnega testa za toksigeno bakterijo C. difficile, (iii) tiste, ki niso prejeli v protokolu opredeljenega standardnega zdravljenja v 1-dnevnem časovnem oknu od infuzije, (iiii) tiste, pri katerih je bila ugotovljena neskladnost z dobro klinično prakso SoC = standardno protibakterijsko zdravljenje (metronidazol ali vankomicin ali fidaksomicin) Enostranska vrednost p na podlagi metode po Miettinenu in Nurminenu, stratificirano po protokolu (MODIFY I in MODIFY II), standardnemu protibakterijskem zdravljenju (metronidazol v primerjavi z vankomicinom v primerjavi s fidaksomicinom) in hospitalizacijskem statusu (bolnišnični v primerjavi z ambulantnimi)
No clinically meaningful differences in the exposure of bezlotoxumab were found between elderly patients 65 years and older and patients under 65 years of age.
Med starejšimi bolniki, starimi 65 let ali več, in bolniki, mlajšimi od 65 let, ni bilo klinično pomembnih razlik v izpostavljenosti bezlotoksumabu.
Citric acid monohydrate (E330) Diethylenetriaminepentaacetic acid Polysorbate 80 (E433)
6.1 Seznam pomožnih snovi citronska kislina monohidrat (E330) dietilentriaminpentaocetna kislina polisorbat 80 (E433) natrijev klorid natrijev citrat dihidrat (E331) voda za injekcije natrijev hidroksid (E524) (za prilagoditev pH)
If you miss an appointment to get ZINPLAVA
Če izpustite obisk pri zdravniku, ko bi morali prejeti zdravilo ZINPLAVA
No anti-bezlotoxumab antibodies were detected after the second dose.
Po drugem odmerku protiteles proti bezlotoksumabu niso zaznali.
It is unknown whether bezlotoxumab is secreted in human milk.
Ni znano, ali se bezlotoksumab izloča v materino mleko.
Warnings and precautions ZINPLAVA is not a treatment for CDI.
Zdravilo ZINPLAVA ni zdravilo za CDI.
ZINPLAVA should not be administered as an intravenous push or bolus.
Zdravila ZINPLAVA se ne sme aplicirati s hitro infuzijo ali z bolusno injekcijo.
ZINPLAVA is a clear to moderately opalescent, colourless to pale yellow liquid.
Zdravilo ZINPLAVA je bistra do zmerno opalescentna, brezbarvna do bledorumena raztopina.
What ZINPLAVA contains - The active substance is bezlotoxumab.
Kaj vsebuje zdravilo ZINPLAVA - Učinkovina je bezlotoksumab.
Nervous system disorders
Priprava razredčene raztopine
• Inspect vial contents for discoloration and particulate matter prior to dilution.
• Pred razredčenjem vsebino viale preglejte in se prepričajte, da ni spremenjene barve in ne vsebuje delcev.
How you are given ZINPLAVA
Kako boste prejeli zdravilo ZINPLAVA
Concomitant oral standard of care (SoC) antibacterial therapy for CDI was given together with ZINPLAVA.
Skupaj z zdravilom ZINPLAVA so bolniki prejemali standardno (SoC - standard of care) protibakterijsko zdravljenje za CDI.
Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Okvara ledvic Pri bolnikih z okvaro ledvic prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
No clinically meaningful differences in the exposure of bezlotoxumab were found between patients with hepatic impairment and patients with normal hepatic function.
Med bolniki z okvaro ledvic in bolniki z normalnim delovanjem ledvic ni bilo klinično pomembnih razlik v izpostavljenosti bezlotoksumabu.
Hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Okvara jeter Pri bolnikih z okvaro jeter prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
• shortness of breath
• siljenje na bruhanje
One 40 mL vial contains 1,000 mg of bezlotoxumab.
Ena 40-mililitrska viala vsebuje 1.000 mg bezlotoksumaba.
In the studies, the clinical cure rates of the presenting CDI episode were comparable between the treatment arms.
Med terapevtskima skupinama v študijah ni bilo razlik v deležu bolnikov, pri katerih je bila klinično ozdravljena trenutna epizoda CDI.
Each mL of concentrate contains 25 mg bezlotoxumab.
En mililiter koncentrata vsebuje 25 mg bezlotoksumaba.
Each mL contains 25 mg bezlotoxumab.
En mililiter vsebuje 25 mg bezlotoksumaba.
Hepatic impairment
Bolezni živčevja pogosti glavobol
Each 40 mL vial contains 1,000 mg bezlotoxumab.
Ena 40-ml viala vsebuje 1.000 mg bezlotoksumaba.
Each vial contains 1,000 mg bezlotoxumab.
Ena viala vsebuje 1.000 mg bezlotoksumaba.
Immune-related adverse reactions
Imunsko pogojeni neželeni učinki
ZINPLAVA with SoC Percent (n/m)
Placebo s SoC Odstotek (n/m)
Injury, poisoning and procedural complications
Poškodbe, zastrupitve in zapleti pri posegih pogosti z infundiranjem povezane reakcije†
How to store ZINPLAVA
Shranjevanje zdravila ZINPLAVA
Clear to moderately opalescent, colourless to pale yellow liquid.
koncentrat za raztopino za infundiranje bistra do zmerno opalescentna, brezbarvna do bledorumena raztopina
- Keep this leaflet.
Glejte navodilo.
• diarrhoea
• utrujenost
7 May 2015
7. maj 2015
The applicant requested a re-examination of the opinion.
Vlagatelj je zahteval ponoven pregled mnenja.
In addition, there were concerns that the safety of the medicine had not been fully demonstrated and one unresolved quality issue.
Poleg tega so obstajali pomisleki o tem, da je bila varnost zdravila v celoti dokazana, ter nerešeno vprašanje glede kakovosti.
As part of its application the company presented the results of a field study involving cats with blood pressure of 160 mmHg or above.
Kot del svoje vloge je družba predstavila rezultate terenske študije na mačkah s krvnim tlakom 160 mmHg ali več.
After considering the grounds for this request, the CVMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 7 May 2015.
Po preučitvi razlogov za to zahtevo je odbor CVMP ponovno pregledal prvotno mnenje in 7. maja 2015 potrdil zavrnitev vloge za pridobitev dovoljenja za promet.
Lodipressin was expected to be used to treat cats with systemic arterial hypertension (high blood pressure).
Zdravilo Lodipressin naj bi se uporabljalo za zdravljenje mačk s sistemsko arterijsko hipertenzijo (visokim krvnim tlakom).
On 15 January 2015, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lodipressin, intended for the treatment of systemic arterial hypertension in cats.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je v svojem negativnem mnenju z dne 15. januarja 2015 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Lodipressin, namenjenim zdravljenju sistemske arterijske hipertenzije pri mačkah.
At the time of the initial evaluation, the CVMP considered that there were deficiencies in the way the field study had been designed and conducted and the results had been presented.
V času začetnega vrednotenja je odbor CVMP presodil, da so bile v načrtovanju in izvedbi terenske študije ter predstavitvi njenih rezultatov pomanjkljivosti.
Refusal of the marketing authorisation for Lodipressin (amlodipine besilate) EMA/55773/2016
Zavrnitev vloge za dovoljenje za promet z zdravilom Lodipressin (amlodipin besilat) EMA/55773/2016