natgillin/translations-raw huggingface dataset:
• The Committee is of the opinion that, based on available results of clinical trials and metaanalyses, the efficacy of alfacalcidol in combination with alendronic acid has been adequately demonstrated.
• je Odbor mišljenja da je, na temelju dostupnih rezultata kliničkih ispitivanja i meta analiza, djelotvornost alfakalcidola u kombinaciji s alendronatnom kiselinom odgovarajuće dokazana.
Valebo is a combination package consisting of tablets containing 70 mg of alendronate sodium (alendronic acid) and soft capsules containing 1µg of alfacalcidol.
Valebo je kombinirani paket koji se sastoji od tableta koje sadrže 70 mg alendronat natrija (alendronatna kiselina) i meke kapsule koje sadrže 1µg alfakalcidola.
The open, multi-centre, prospective studies (Schacht and Ringe, 20121, Schacht and Ringe, 20112) demonstrated that treatment with alfacalcidol 1 μg resulted in significant increases in physical performance and balance in elderly women and men with and without an increased risk of falls as well as with and without Vitamin D insufficiency/deficiency.
Otvorena, prospektivna ispitivanja (Schacht i Ringe, 2012.1, Schacht i Ringe, 2011.2) provedena u više centara dokazala su da je liječenje dozom alfakalcidola od 1 μg rezultiralo značajnim povećanjem u fizičkoj učinkovitosti i ravnoteži u starijih žena i muškaraca s i bez povećanog rizika od padova, kao i s i bez insuficijencije/deficijencije vitamina D.
• The Committee reviewed all the data submitted by the applicant in order to support the role of alfacalcidol in the reduction of the fall rate.
• je Odbor pregledao sve podatke dostavljene od strane podnositelja zahtjeva kako bi podržalo ulogu alfakalcidola u smanjivanju stope padova.
Alfacalcidol is a vitamin D analogue which acts as a regulator of calcium and phosphate metabolism.
Alfakalcidol je analog vitaminu D koji djeluje kao regulator metabolizma kalcija i fosfata.
the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure with the amendment as mentioned in Annex III for Valebo and associated names (see Annex I).
CHMP je preporučio izdavanje odobrenja za stavljanje lijeka u promet za koje sažetak opisa svojstava lijeka, etiketa i uputa o lijeku ostaju jednaki konačnim verzijama usuglašenima tijekom postupka koordinacijske grupe s izmjenama navedenima u Prilogu III. za lijek Valebo i povezane nazive (vidi Prilog I.).
Dukas et al (2004) presented a randomised, double-blind, placebo controlled trial with ‘number of fallers' as primary endpoint and an adequate number of patients.
Dukas et al (2004.) predstavili su randomizirano, dvostruko slijepo ispitivanje kontrolirano placebom s „brojem osoba koje padaju” kao primarnom završnom točkom i primjerenim brojem bolesnika.
The applicant claimed that alfacalcidol 1 μg daily and of calcitriol 0.25 μg twice a day are therapeutically equivalent, and therefore they considered that the results of this randomised clinical trial can be directly extrapolated to alfacalcidol.
Podnositelj zahtjeva tvrdio je da su doza alfakalcidola od 1 μg dnevno i doza kalcitriola od 0,25 μg dva puta dnevno terapijski ekvivalenti, te stoga oni smatraju da se rezultati ovog randomiziranog kliničkog ispitivanja mogu ekstrapolirati na alfakalcidol.
Alfacalcidol is indicated in various conditions where there is a disturbance of calcium or phosphorus metabolism.
Alfakalcidol indiciran je za različita stanja, u kojima postoji poremećaj metabolizma kalcija ili fosfora.
The CHMP was of the opinion that results with calcitriol could be used as supportive data but not to conclude about the role of alfacalcidol in fall rate without confirmatory studies with alfacalcidol.
CHMP je bio mišljenja da se rezultati prikupljeni za kalcitriol mogu iskoristiti kao potporni podaci, no ne pružaju nikakve zaključke o ulozi alfakalcidola u stopi padova bez potvrdnih ispitivanja s alfakalcidolom.
To support the inclusion of this indication the application should be based on parallel-group, randomised, double-blind, placebo or comparator controlled clinical trials with an adequate number of patients.
U prilog uključivanja ove indikacije, zahtjev se mora temeljiti na randomiziranim, dvostruko slijepim kliničkim ispitivanjima kontroliranima paralelnim grupama, placebom ili komparatorom s primjerenim brojem bolesnika.
The applicant performed a meta-analysis of the most relevant clinical studies (Gallagher, 2004; Dukas, 2004; Ringe, 201310 and Kaya, 201111) reporting the number of fallers following either alfacalcidol or calcitriol therapy.
Podnositelj zahtjeva proveo je meta analizu najvažnijih kliničkih ispitivanja (Gallagher, 2004.; Dukas, 2004.; Ringe, 2013.10 i Kaya, 2011.11) koja su prijavila broj osoba koje padaju nakon terapije alfakalcidolom ili kalcitriolom.
Rheumatol Int 2013;33(3):637-43; Epub 2012 Apr 8.
Rheumatol Int 2013;33(3):637-43; Epub 2012 Apr 8. 11 Kaya U et al.
Systemic levels are shown to be equivalent at steady state under scaled dosing and there is no significant difference in predicted AUC's (Area Under the Curve) at six months between alfacalcidol 1 μg once-aday (QD) and calcitriol 0.25 μg twice-daily (BID).
Dokazano je da su sistemske razine ekvivalentne u stabilnom stanju pri skaliranom doziranju te da nema značajne razlike u predviđenom AUC-u (području ispod krivulje) u šest mjeseci između alfakalcidola od 1 μg jednom dnevno (QD) i kalcitriola od 0,25 μg dva puta dnevno (BID).
The major concern raised by Spain could not be solved during the CMDh referral and the issue was therefore referred to the CHMP.
Najvažnije pitanje sigurne primjene, koje je istaknula Španjolska nije uspješno riješeno tijekom postupka upućivanja CMDh-u, te je stoga predmet upućen CHMP-u.
The proposed indication by the applicant for Valebo was the “Treatment of postmenopausal osteoporosis.
Predložena indikacija od strane podnositelja zahtjeva za stavljanje u promet lijeka Valebo glasila je „liječenje postmenopauzane osteoporoze.
A referral was thus triggered at the CMDh.
Stoga je započet postupak upućivanja CMDh-u.
During the decentralised procedure, concerned member states (CMS) expressed the opinion that the role of alfacalcidol in the reduction in the fall rate has not been demonstrated.
Tijekom decentraliziranog postupka, zemlje članice sudionice u postupku (CMS) iznijele su svoja mišljenja da nije dokazana uloga alfakalcidola u stopi pada.
Alendronic acid is indicated in the treatment of postmenopausal osteoporosis (PMO).
Alendronatna kiselina indicirana je za liječenje postmenopauzne osteoporoze (PMO-a).
Having considered that data submitted by the applicant, the CHMP considered that there is sufficient evidence to conclude that in some clinical studies, alfacalcidol has been shown to reduce the risk of falls in the elderly.
Nakon razmatranja podataka koje je dostavio podnositelj zahtjeva, CHMP je zaključio da postoji dovoljno dokaza za donošenje zaključka kako je u pojedinim kliničkim ispitivanjima dokazano da alfakalcidol smanjuje rizik od padova u starijih osoba.
These studies demonstrated the efficacy of the vitamin D analogues alfacalcidol and calcitriol on falls in elderly men and women and in postmenopausal women without diagnosed vitamin D insufficiency.
Ova su ispitivanja pokazala da djelotvornost analoga vitamina D, alfakalcidola i kalcitriola, za padove u starijih muškaraca i žena kao i u postmenopauzanih žena u kojih nije dijagnosticirana insuficijencija vitamina D.
Other studies had been performed to specifically investigate the efficacy and safety of alfacalcidol in monotherapy and combination therapy on the reduction of falls in elderly and patients with PMO (Dukas, 20043; Gallagher, 20044; Ringe, 20075).
Druga su ispitivanja provedena kako bi se posebice istražila djelotvornost i sigurnost alfakalcidola u monoterapiji i kombiniranoj terapiji za smanjenje broja padova u starijih osoba i bolesnika koji boluju od PMO-a (Dukas, 2004.3; Gallagher, 2004.4; Ringe, 2007.5).
Alendronic acid reduces the risk of vertebral and hip fractures, whilst a significant reduction in the fall rate has been demonstrated for alfacalcidol in the elderly”.
Alendronatna kiselina smanjuje rizik od vertebralnih prijeloma i prijeloma kuka, pri čemu je dokazano značajno smanjenje u stopi pada za alfakalcidol u starijih osoba”.
However, the CHMP agreed to provide the respective information in the section 5.1 of the SmPC “In some clinical studies, alfacalcidol has been shown to reduce the risk of falls in the elderly”.
No, CHMP je suglasan da se odgovarajuće informacije navedu u dijelu 5.1 SPC-a „U pojedinim kliničkim ispitivanjima dokazano je da alfakalcidol smanjuje rizik od padova u starijih osoba”.
Gallagher et al (2004) examined the effects of calcitriol on falls in a randomised, double-blind, placebocontrolled study in 489 postmenopausal, Vitamin D replete/sufficient women with osteopenia.
Gallagher et al (2004.) ispitali su djelovanje kalcitriola na padove u randomiziranom, dvostruko slijepom ispitivanju kontroliranom placebom u 489 postmenopauzanih žena s popunjenošću/viškom vitamina D, koje boluju od osteopenije.
The applicant has analysed pharmacokinetics data of alfacalcidol and calcitriol dosed independently from two bioequivalence studies.
Podnositelj zahtjeva analizirao je farmakokinetičke podatke alfakalcidola i kalcitriola koji su dozirani nezavisno od dva ispitivanja bioekvivalentnosti.
Ringe et al (2007) presented a randomised trial, where three treatments were compared ‘alfacalcidol alone', ‘alfacalcidol + alendronate' and ‘alendronate + vitamin D + calcium'.
Ringe et al (2007.) predstavio je randomizirano ispitivanje, u kojem su uspoređena tri liječenja; i to „monoterapija alfakalcidolom”, „alfakalcidol + alendronat” i „alendronat + vitamin D + kalcij”.
The results over 36 weeks showed that alfacalcidol treatment was associated with fewer non-significantly fallers than placebo (OR (Odds ratio) 0.69, 95% CI (confidence interval): 0.41-1.16).
Rezultati prikupljeni tijekom 36 tjedana pokazali su da je liječenje alfakalcidolom povezano s manje osoba s neznačajnim padom u odnosu na placebo (OR (omjer izgleda) 0,69, 95% CI (interval pouzdanosti): 0,41-1,16).
Alendronic acid is a bisphosphonate with high affinity for the hydroxylapatite of the bone.
Alendronatna kiselina je bisfosfonat s visoki afinitetom za hidroksilapatit kosti.
Higher performance in functional tests is associated with a significantlylower number of fallers and risk of falls, therefore the positive effects of alfacalcidol treatment on physical performance should be considered for the assessment of the results of alfacalcidol in the reduction of falls in elderly and in patients with PMO.
Visoka učinkovitost u funkcionalnim testovima povezana je sa značajno manjim brojem osoba koje su pale i rizikom od padova, stoga se pozitivni učinci liječenja alfakalcidolom na fizičku učinkovitost trebaju uzeti u razmatranje pri ocjeni rezultata alfakalcidola u smanjenju padova u starijih osoba i u bolesnika koji boluju od PMO-a.
Treatment with calcitriol 0.25 μg twice daily significantly reduced the number of fallers (OR 0.54 (95% CI 0.31-0.94, p<0.03) and decreased the incidence of falls compared to placebo (0.27 versus 0.43, p=0.0015) in this 3 years trial.
Liječenje dozom kalcitriola od 0,25 μg dva puta dnevno značajno je smanjilo broj osoba koje su padale (OR 0,54 (95% CI 0,31-0,94, p<0,03) te je smanjio incidenciju padova u usporedbi s placebom (0,27 u odnosu na 0,43, p=0,0015) u ovom trogodišnjem ispitivanju.
Furthermore, the applicant claimed that these results on alfacalcidol monotherapy have been confirmed in a post-approval trial of the combination package of 70 mg alendronate weekly and 1 μg
Nadalje, podnositelj zahtjeva tvrdio je da su ovi rezultati monoterapije alfakalcidolom potvrđeni uispitivanjima provedenima nakon izdavanja odobrenja za stavljanje lijeka u promet za kombinirani paket od 70 mg alendronata tjedno i 1 μg alfakalcidola dnevno (Tevabone).
Alfacalcidol alone was slightly superior to alendronate + plain Vitamin D + calcium after two years (MW = 0.5422; CI-LB = 0.4838; p = 0.0785).
Monoterapija alfakalcidolom bila je neznatno superiornija u odnosu na terapiju alendronatom + običnim vitaminom D + kalcijem nakon dvije godine (MW = 0,5422; CI-LB = 0,4838; p = 0,0785).
The applicant also provided a population modelling and simulation of results to demonstrate that there is no difference between alfacalcidol and calcitriol treatments at appropriate and equivalent dosing.
Podnositelj zahtjeva također je dostavio modeliranje populacije i simulaciju rezultata kako bi dokazao da nema razlike između liječenja alfakalcidolom i kalcitriolom u odgovarajućoj i ekvivalentnoj dozi.
The CHMP agreed to provide the respective information in section 5.1 of the Summary of the Product Characteristics and section 1 of the package leaflet.
CHMP je pristao dostaviti odgovarajuću informaciju u dijelu 5.1 Sažetka opisa svojstava lijeka i dijelu 1.
The analysis has demonstrated that there is no difference in calcitriol exposure at steady state after administration of either alfacalcidol or calcitriol at appropriate and equivalent dosing.
Analiza je pokazala da nema razlike u izlaganju kalcitriolu u stabilnom stanju nakon primjene alfakalcidola ili kalcitriola u odgovarajućem i ekvivalentnom doziranju.
In order to demonstrate the role of alfacalcidol in the reduction of falls, the applicant made reference to published clinical studies which support the effect of alfacalcidol alone and in combination with alendronic acid on the improvement of physical performance, the incidence of non-vertebral fractures and on falls.
Kako bi se dokazala uloga alfakalcidola u smanjivanju broja padova, podnositelj zahtjeva referirao je na objavljena klinička ispitivanja koja podržavaju djelovanje alfakalcidola kao monoterapije te u kombinaciji s alendronatnom kiselinom o poboljšanoj fizičkoj učinkovitosti, incidenciji nevertebralnih prijeloma i o padovima.
The combination ‘alendronate + alfacalcidol' showed a significant superiority in reduction of falls compared to ‘alendronate + plain Vitamin D + calcium' after two years (MannWhitney (MW) = 0.5506; Confidence interval Lower bound (CI-LB) = 0.4937; p=0.0407) but not superiority to ‘alfacalcidol alone'.
Kombinacija „alendronat + alfakalcidol” pokazala je značajnu superiornost u smanjenju broja padova u usporedbi s „alendronatom + običnim vitaminom D + kalcijem” nakon dvije godine (Mann-Whitney (MW) = 0,5506; donja granica intervala pouzdanosti(CI-LB) = 0,4937; p=0,0407), no ne i superiornost u odnosu na „monoterapiju alfakalcidolom”.
Significant fall reduction in alfacalcidol-treated subject with a total calcium intake of more than 512 mg/d (median Ca intake in the study) (OR 0.45; 95% CI 0.21-0.97, p=0.042) was observed but not in those with less Ca intake than 512 mg/d (OR 1.00, 95% CI 0.47-2.11, p=0.998).
Uočeno je značajno smanjenje pada u subjekata liječenih alfakalcidolom s ukupnim unosom kalcija većim od 512 mg/d (medijan unosa Ca u ispitivanju) (OR 0,45; 95% CI 0,210,97, p=0,042), no ne u onih osoba s unosom Ca manjim od 512 mg/d (OR 1,00, 95% CI 0,47-2,11, p=0,998).
10 Ringe JD, Farahmand P, Schacht E. Alfacalcidol in men with osteoporosis: a prospective, observational, 2-year trial on
Alfacalcidol in men with osteoporosis: a prospective, observational, 2-year trial on
Richy F, Dukas L, Schacht E. Differential effects of D-hormone analogs and native Vitamin D on the risk of falls: A comparative meta-analysis.
Differential effects of D-hormone analogs and native Vitamin D on the risk of falls: A comparative meta-analysis.
Studies on reduction of falls and fall-related non-vertebral fractures
Ispitivanja smanjenja broja padova i nevertebralnih prijeloma povezanih s padovima
The analysis was done using population pharmacokinetic modelling to confirm the exchangeability of alfacalcidol and calcitriol when administrated at appropriately scaled doses.
Analiza je provedena primjenom populacijskog farmakokinetičkog modeliranja kako bi se potvrdila zamjenjivost alfakalcidola i kalcitriola prilikom primjene u odgovarajućim određenim dozama.
The applicant further performed a meta-analysis of trials with alfacalcidol and calcitriol investigating fallers.
Nadalje, podnositelj zahtjeva proveo je meta analizu ispitivanja s alfakalcidolom i kalcitriolom istražujući osobe koje su padale.
O'Donnell S, Moher D, Thomas K, Hanley D A, Cranney A. Systematic review of the benefits and harms of calcitriol and alfacalcidol for fractures and falls.
O'Donnell S, Moher D, Thomas K, Hanley D A, Cranney A.
In addition, 500 mg of calcium daily was added in each arm. Amongst other parameters the authors compared the rate of falls between the three groups.
Nadalje, 500 mg kalcija dnevno dodano je u svaku ruku.
Alfacalcidol improves muscle power, muscle function and balance in elderly patients with reduced bone mass. Rheumatol Int 2012;32(1):207-15.
Alfacalcidol improves muscle power, muscle function and balance in elderly patients with reduced bone mass.
The applicant claimed that since no significant difference in numbers of falls was found between the groups treated with the combination of ‘alendronate + alfacalcidol' and ‘alfacalcidol alone', this underlines the efficacy of alfacalcidol as monotherapy as well as in combination with alendronate for the reduction of falls.
tvrdio je da nema značajnih razlika u količini padova utvrđenoj za svaku grupu liječenu kombinacijom „alendronata + alfakalcidola” i „monoterapijom alfakalcidola”.
Meta-analysis of trials on alfacalcidol and calcitriol investigating fallers
Meta analiza ispitivanja u osoba koje padaju, a uzimaju alfakalcidolon i kalcitriolon
Dukas L, Bischoff HA, Lindpainter LS, Schacht E, Birkner-Binder D, Damm TN, Thalman B, Stähelin HB. Alfacalcidol reduces the number of fallers in a community-dwelling elderly population with a minimum calcium intake of more than 500 mg daily.
Dukas L, Bischoff HA, Lindpainter LS, Schacht E, Birkner-Binder D, Damm TN, Thalman B, Stähelin HB.
Date of first authorisation: 06/11/2015.
Datum prvog odobrenja: 06/11/2015
One carton contains one blister of 1, 3 or 6 tablets.
Jedna kartonska kutija sadrži jedan blister s 1, 3 ili 6 tableta.
Aluminium foil/foil blister package.
Aluminijska folija/folija blister pakovanje.
The bioavailability of sarolaner following oral dosing was high at >85%.
Biološka raspoloživost sarolanera nakon peroralne primjene visoka je >85%.
The depletion from tissues was consistent with the plasma half-life.
Deplecija iz tkiva je u skladu s polu-životom u plazmi.
Half-life was comparable for the intravenous and oral routes at 12 and 11 days, respectively.
Poluživot je usporediv s intravenoznom i peroralnom primjenom 11. i 12. dan.
Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart.
Liječenje treba nastaviti sve dok testovi strugotina kože nisu negativni, najmanje dva uzastopna puta, u roku od mjesec dana.
The veterinary medicinal product should be administered at a dose of 2-4 mg/kg bodyweight in accordance with the following table:
Veterinarsko-medicinski proizvod treba davati u dozi 2 - 4 mg/kg tjelesne težine u skladu sa sljedećom tablicom:
During clinical field trials, no interactions between Simparica chewable tablets for dogs and routinely used veterinary medicinal products were observed.
Tijekom kliničkih terenskih ispitivanja nisu primijećene interakcije između Simparica tableta za žvakanje za pse i uobičajeno korištenih veterinarsko-medicinskih proizvoda.
For the treatment of demodicosis (caused by Demodex canis) the administration of a single dose once monthly for three consecutive months is efficacious and leads to a marked improvement of clinical signs.
Za liječenje demodikoze (uzrokovane Demodex canis) učinkovita je primjena jedne doze jednom mjesečno, tri uzastopna mjeseca, koja dovodi do značajnog poboljšanja kliničkih znakova.
A distribution study determined that 14C-sarolaner-related residues were widely distributed to the tissues.
Studije distribucije su utvrdile da su ostaci povezani s 14C-sarolanerom široko rasprostranjeni u tkivima.
For each strength, the chewable tablets are available in the following pack sizes: carton with 1 blister of 1, 3 and 6 tablets.
Tablete za žvakanje dostupne su za svaku jačinu u sljedećim veličinama pakovanja: karton s 1 blisterom od 1¸ 3 ili 6 tableta.
EU/2/15/191/001-018
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/15/191/001-018
In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 1.3 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
U nedostatku dostupnih podataka, liječenje štenaca mlađih od 8 tjedana starosti i lakših od 1,3 kg tjelesne težine trebalo bi bazirati na procjeni koristi/rizika od strane odgovornog veterinara.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
U slučaju nehotičnog gutanja, hitno zatražiti savjet liječnika i pokazati mu naljepnicu ili uputu o veterinarsko-medicinskom proizvodu.
The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Veterinarsko-medicinski proizvod može se koristiti kao dio strategije liječenja u kontroli alergijskog dermatitisa uzrokovanih buhama.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in animals intended for breeding.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta, laktacije ili u životinja namijenjenim za parenje.
Use appropriate combination of available strengths to achieve the recommended dose of 2-4 mg/kg.
Upotrijebite odgovarajuću kombinaciju raspoloživih jačina tableta da bi postigli preporučenu dozu od 2-4 mg/kg tjelesne težine.
Hypromellose acetate succinate, medium grade Lactose monohydrate
Hipromeloza acetat sukcinat, srednje kvaliteteLaktoza monohidrat
Sarolaner was dose proportional in Beagle dogs when dosed from the intended use dose of 2-4 mg/kg, to 20 mg/kg.
Sarolaner je bio razmjeran dozi kod pasa pasmine Beagle, kod doziranja propisane doze 2 do 4 mg/kg do doze 20 mg/kg tjelesne težine.
For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis).
Za liječenje infestacije buhama (Ctenocephalides felis i Ctenocephalides canis).
The accidental ingestion of the product may potentially result in adverse effects, such as transient excitatory neurological signs.
Slučajno gutanje proizvoda može dovesti do neželjenih učinaka, kao što su prolazni neurološki simptomi (ekscitacija).
PACKAGE LEAFLET: Simparica chewable tablets for dogs
UPUTA O VMP: Simparica tablete za žvakanje za pse
The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks.
Veterinarsko-medicinski proizvod ima trenutno i postojano djelovanje ubijanja krpelja najmanje 5 tjedana.
In a margin of safety study, the veterinary medicinal product was administered orally to 8 week old Beagle puppies at doses of 0, 1, 3, and 5 times the maximum exposure dose of 4 mg/kg at 28 day intervals for 10 doses.
U granicama istraživanja neškodljivosti, veterinarsko-medicinski proizvod primjenjivao se peroralno štencima starim 8 tjedana pasmine Beagle u dozi 0, 1, 3 i 5 puta većoj od najveće preporučene doze, (4 mg/kg tjelesne težine) kroz 28 dana u 10 doza.
Mottled brown coloured, square shaped chewable tablets with rounded edges.
Tablete za žvakanje obojene šareno smeđom bojom, kvadratnog oblika sa zaobljenim rubovima.
EU/2/15/191/011 (40 mg, 3 tablets) EU/2/15/191/012 (40 mg, 6 tablets) EU/2/15/191/013 (80 mg, 1 tablet) EU/2/15/191/014 (80 mg, 3 tablets) EU/2/15/191/015 (80 mg, 6 tablets) EU/2/15/191/016 (120 mg, 1 tablet) EU/2/15/191/017 (120 mg, 3 tablets) EU/2/15/191/018 (120 mg, 6 tablets)
EU/2/15/191/011 (40 mg, 3 tablete) EU/2/15/191/012 (40 mg, 6 tableta) EU/2/15/191/013 (80 mg, 1 tableta) EU/2/15/191/014 (80 mg, 3 tablete) EU/2/15/191/015 (80 mg, 6 tableta) EU/2/15/191/016 (120 mg, 1 tableta) EU/2/15/191/017 (120 mg, 3 tablete) EU/2/15/191/018 (120 mg, 6 tableta)