natgillin/translations-raw huggingface dataset:
The recommended dosage is 13.1 mg amoxicillin (equivalent to 18.8 mg veterinary medicinal product) per kg body weight for 3 days or in severe cases for 5 days.
Priporočeni odmerek je 13,1 mg amoksicilina (kar ustreza 18,8 mg zdravila za uporabo v veterinarski medicini) na kg telesne teže za 3 dni ali v hujših primerih za 5 dni.
The recommended dosage for chickens is 13.1 mg amoxicillin (equivalent to 18.8 mg veterinary medicinal product) per kg body weight for 3 days or in severe cases for 5 days.
Priporočeni odmerek za piščance je 13,1 mg amoksicilina (kar ustreza 18,8 mg zdravila za uporabo v veterinarski medicini) na kg telesne mase, uporabljenega tri dni ali v hujših primerih pet dni.
For turkeys the recommended dosage is 13.1-17.4 mg amoxicillin (equivalent to 18.8 to 25 mg veterinary medicinal product) per kg body weight for 3 days or in severe cases for 5 days.
Za purane je priporočeni odmerek 13,1-17,4 mg amoksicilina (kar ustreza od 18,8 do 25 mg zdravila za uporabo v veterinarski medicini) na kg telesne mase, uporabljenega tri dni ali v hujših primerih pet dni.
• The Committee considered the notification of the referral triggered by Germany under Article 29(4) of Directive 2001/83/EC.
• odbor je upošteval obvestilo o napotitvenem postopku, ki ga je sprožila Nemčija skladno s členom 29(4) Direktive 2001/83/ES.
Spain considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Španija je menila, da bi lahko odobritev dovoljenja za promet pomenila resno tveganje za javno zdravje;
Overall summary of the scientific evaluation of Valebo and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Valebo in povezanih imen (glejte Prilogo I)
These results are supported by two other studies published by Ringe and Schacht (2012, 2013).
Te rezultate sta potrdili tudi dve drugi študiji, ki sta ju objavila Ringe in Schacht (2012, 2013).
Studies on physical performance and balance
Študiji o telesni zmogljivosti in ravnotežju
Both active substances are currently authorised either as monotherapy or in association (combination pack).
Obe zdravilni učinkovini sta trenutno odobreni bodisi kot monoterapija ali v kombinaciji (v kombiniranem pakiranju).
The decentralised procedure was closed on day 210, with most of the CMS agreeing with the conclusions of the reference member state except Spain which raised a potential serious risk to public health (PSRPH).
Decentralizirani postopek se je končal na 210. dan, ko je večina zadevnih držav članic soglašala z zaključki referenčne države članice, z izjemo Španije, ki je izrazila zaskrbljenost zaradi možnega resnega tveganja za javno zdravje (PSRPH).
Studies on reduction of falls and fall-related non-vertebral fractures
Študije o zmanjšanju števila padcev in z njimi povezanih nevretenčnih zlomov
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.
Poleg tega so zdravilom v vsaki skupini dodajali še 500 mg kalcija na dan. Eden od parametrov, ki so jih primerjali med tremi skupinami, je bila stopnja padcev.
However, the Committee considered that the statement on the reduction in the fall rate in the elderly should not be included in the indication.
Vendar pa je menil, da se v indikacijo ne sme vključiti trditve o znižanju stopnje padcev pri starejših.
The results showed a consistent odds ratio at around 0.65 in all analyses, suggesting a reliable estimated of treatment effect as compared to placebo.
Rezultati so v vseh analizah pokazali dosledno razmerje obetov, ki je bilo približno 0,65, kar kaže na zanesljivo oceno učinka zdravljenja v primerjavi s placebom.
Bisphosphonates have strong pharmacodynamic action on osteoclast activity.
Bisfosfonati imajo močan farmakodinamični učinek na osteoklastno aktivnost.
The major concern raised by Spain could not be solved during the CMDh referral and the issue was therefore referred to the CHMP.
Ker glavnega zadržka, ki ga je izpostavila Španija, med napotitvenim postopkom skupine CMDh ni bilo mogoče razrešiti, je bila zadeva napotena na odbor CHMP.
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).
je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, za katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostajajo enaki kot zadnje različice, pripravljene med postopkom usklajevalne skupine, z izjemo ene spremembe, kot je navedeno v Prilogi III za zdravilo Valebo in povezana imena (glejte Prilogo I).
Population pharmacokinetic modelling and simulation at steady state
Populacijski farmakokinetični modeli in simulacija v stacionarnem stanju
It is converted rapidly in the liver to 1,25 dihydroxyvitamin D, so called calcitriol.
V jetrih se hitro pretvori v 1,25-dihidroksivitamin D, ki mu pravimo tudi kalcitriol.
In addition, the results of these studies, showing a significant reduction in fall-related non-vertebral fractures, have been confirmed by independent meta-analyses (Bischoff-Ferrari, 2004b6; BischoffFerrari, 20097; O'Donnell, 20088; Richy, 20089).
Poleg tega so rezultate teh študij, ki so pokazali znatno zmanjšanje števila nevretenčnih zlomov, povezanih s padci, potrdile neodvisne metaanalize (Bischoff-Ferrari, 2004b6; Bischoff-Ferrari, 20097; O'Donnell, 20088; Richy, 20089).
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.
Med decentraliziranim postopkom so zadevne države članice izrazile mnenje, da vloga alfakalcidola pri znižanju stopnje padcev ni bila dokazana.
The proposed indication by the applicant for Valebo was the “Treatment of postmenopausal osteoporosis.
Predlagatelj je za zdravilo Valebo predlagal naslednjo indikacijo: „Zdravljenje postmenopavzalne osteoporoze.
Alendronic acid is indicated in the treatment of postmenopausal osteoporosis (PMO).
Alendronska kislina je indicirana za zdravljenje postmenopavzalne osteoporoze (PMO).
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.
Da bi podprli vključitev te indikacije, mora vloga temeljiti na randomiziranih dvojno slepih kliničnih preskušanjih, nadzorovanih s placebom ali primerjalnim zdravilom, z vzporednima skupinama in zadostnim številom bolnikov.
• 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.
• odbor je na podlagi razpoložljivih rezultatov kliničnih preskušanj in metaanaliz menil, da je bila učinkovitost alfakalcidola v kombinaciji z alendronsko kislino zadovoljivo dokazana.
Hence, the treatment effect in a grouped meta-analysis, even with trials where ‘fallers' was not always the primary endpoint, remains significant independent of study design differences.
To pomeni, da so v metaanalizi združenih preskušanj, tudi tistih, v katerih „posamezniki, ki so padli“, niso bili vedno primarna končna točka, ugotovili velik učinek zdravljenja, tudi če so obstajale razlike v zasnovah študij.
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.
Potem ko je proučil podatke, ki jih je predložil predlagatelj, je CHMP menil, da obstajajo zadostni dokazi za zaključek, da je alfakalcidol v nekaterih kliničnih študijah dokazano zmanjšal tveganje za padce pri starejših.
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 zdravilo v kombiniranem pakiranju, ki se sestoji iz tablet, ki vsebujejo 70 mg natrijevega alendronata (alendronske kisline), in mehkih kapsul, ki vsebujejo 1 µg alfakalcidola.
A post hoc analyses by medians of total calcium intake detected statistically significant differences.
Analize post hoc po medianah skupnega vnosa kalcija so razkrile statistično značilne razlike.
• 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.
• odbor je pregledal vse podatke, ki jih je predložil predlagatelj, da bi dokazal, da alfakalcidol ima vlogo pri znižanju stopnje padcev;
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).
V drugih študijah so posebej proučevali učinkovitost in varnost alfakalcidola v monoterapiji in v kombinaciji pri zmanjšanju števila padcev pri starejših in bolnicah s PMO (Dukas, 20043; Gallagher, 20044; Ringe, 20075).
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.
Predlagatelj je trdil, da sta alfakalcidol v odmerku 1 µg na dan in kalcitriol v odmerku 0,25 µg dvakrat na dan terapevtsko enakovredna, zaradi česar naj bi bilo mogoče rezultate tega randomiziranega kliničnega preskušanja neposredno ekstrapolirati na alfakalcidol.
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.
Odprti multicentrični prospektivni študiji (Schacht in Ringe, 20121, Schacht in Ringe, 20112) sta pokazali, da je zdravljenje z alfakalcidolom v odmerku 1 µg povzročilo znatno izboljšanje telesne zmogljivosti in ravnotežja pri starejših ženskah in moških, pri katerih je ali ni obstajalo povečano tveganje za padce in pri katerih so se ali pa se niso pojavljale nezadostne količine/pomanjkanje vitamina D.
The applicant has analysed pharmacokinetics data of alfacalcidol and calcitriol dosed independently from two bioequivalence studies.
Predlagatelj je analiziral farmakokinetične podatke o alfakalcidolu in kalcitriolu, uporabljenih samostojno, iz dveh študij biološke enakovrednosti.
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.
Predlagatelj je izvedel metaanalizo najpomembnejših kliničnih študij (Gallagher, 2004; Dukas, 2004; Ringe, 201310 in Kaya, 201111) z objavljenim številom posameznikov, ki so padli med zdravljenjem z bodisi alfakalcidolom ali kalcitriolom.
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 se je strinjal, da se ustrezne informacije o tem vključijo v poglavje 5.1 povzetka glavnih značilnosti zdravila in v poglavje 1 navodila za uporabo;
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.
Boljši rezultati pri funkcijskih testih so povezani z znatno manjšim številom posameznikov, ki padejo, in z manjšim tveganjem za padce, zato bi bilo treba pozitivne učinke zdravljenja z alfakalcidolom na telesno zmogljivost upoštevati pri oceni rezultatov v zvezi z učinkom alfakalcidola na zmanjšanje števila padcev pri starejših in bolnicah s PMO.
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”.
Alendronska kislina zmanjša tveganje za zlom vretenc in kolkov, alfakalcidol pa dokazano znatno zniža stopnjo padcev pri starejših.“
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.
Prav tako je predlagatelj zagotovil populacijske modele in simulacijo rezultatov, da bi dokazal, da med zdravljenjem z alfakalcidolom in kalcitriolom ob ustreznem in enakovrednem odmerjanju ni nobene razlike.
Ringe et al (2007) presented a randomised trial, where three treatments were compared ‘alfacalcidol alone', ‘alfacalcidol + alendronate' and ‘alendronate + vitamin D + calcium'.
(2007) so opravili randomizirano preskušanje, v katerem so med seboj primerjali tri zdravljenja: „alfakalcidol v monoterapiji“, „alfakalcidol + alendronat“ in „alendronat + vitamin D + kalcij“.
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 menil, da se rezultati preskušanja s kalcitriolom lahko uporabijo kot podporni podatki, ni pa mogoče iz njih podati zaključkov o vlogi alfakalcidola pri znižanju stopnje padcev, saj jih je najprej treba potrditi v študijah z alfakalcidolom.
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 po 36 tednih so pokazali, da je bilo zdravljenje z alfakalcidolom povezano z neznačilno manjšim številom posameznikov, ki so padli, v primerjavi s placebom (RO (razmerje obetov) 0,69, 95-odstotni IZ (interval zaupanja): 0,41-1,16).
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.
Te študije so pokazale, da sta analoga vitamina D, alfakalcidol in kalcitriol, učinkovita pri zmanjšanju števila padcev pri starejših moških in ženskah ter ženskah v postmenopavzalnem obdobju, ki nimajo pomanjkanja vitamina D.
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.
(2004) so opravili randomizirano dvojno slepo s placebom nadzorovano preskušanje s primarno končno točko „število posameznikov, ki so padli“, in zadostnim številom bolnikov.
The CHMP considered that the statement on falls should not be included in the section 4.1 of the SmPC.
CHMP je menil, da trditve o padcih ne bi smeli vključiti v poglavje 4.1 povzetka glavnih značilnosti zdravila.
Alfacalcidol is a vitamin D analogue which acts as a regulator of calcium and phosphate metabolism.
Alfakalcidol je analog vitamina D, ki s svojim delovanjem uravnava presnovo kalcija in fosfatov.
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.
(2004) so raziskali učinke kalcitriola na padce v randomizirani dvojno slepi s placebom nadzorovani študiji pri 489 ženskah v postmenopavzalnem obdobju in s popolno/zadostno zalogo vitamina D, ki so imele osteopenijo.
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.
Zdravljenje s kalcitriolom v odmerku 0,25 µg dvakrat na dan je v tem 3-letnem preskušanju znatno zmanjšalo število posameznikov, ki so padli (RO 0,54 (95-odstotni IZ 0,31-0,94, p < 0,03), in zmanjšalo incidenco padcev v primerjavi s placebom (0,27 v primerjavi z 0,43, p = 0,0015).
Alendronic acid is a bisphosphonate with high affinity for the hydroxylapatite of the bone.
Alendronska kislina je bisfosfonat, ki ima veliko afiniteto do hidroksiapatita v kosteh.
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).
Pomembno zmanjšanje števila padcev so opazili pri osebah, zdravljenih z alfakalcidolom, s skupnih vnosom kalcija več kot 512 mg/dan (mediana vnosa kalcija v študiji) (RO 0,45; 95-odstotni IZ 0,21-0,97, p = 0,042), ne pa tudi pri osebah z vnosom kalcija manj kot 512 mg/dan (RO 1,00, 95-odstotni IZ 0,47-2,11, p = 0,998).
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.
Da bi dokazal, da alfakalcidol ima vlogo pri zmanjšanju števila padcev, je predlagatelj navedel objavljene klinične študije, ki dokazujejo, da alfakalcidol tako v monoterapiji kot v kombinaciji z alendronsko kislino vpliva na izboljšanje telesne zmogljivosti ter zmanjšanje incidence nevretenčnih zlomov in padcev.
The treatment effect was always significant when major reported trials were analysed together.
Ko so skupaj analizirali pomembnejša objavljena preskušanja, so vedno ugotovili, da je bil učinek zdravljenja velik.
The analysis was done using population pharmacokinetic modelling to confirm the exchangeability of alfacalcidol and calcitriol when administrated at appropriately scaled doses.
Analizo je opravil z uporabo populacijskega farmakokinetičnega modela, da bi potrdil, da sta alfakalcidol in kalcitriol enakovredna, kadar se uporabljata v ustrezno velikih odmerkih.
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).
Prav tako so ugotovili, da je sistemska izpostavljenost v stacionarnem stanju pri enakovrednem odmerjanju enaka in da v predvidenih AUC (površina pod krivuljo) po šestih mesecih pri alfakalcidolu v odmerku 1 µg enkrat na dan in kalcitriolu v odmerku 0,25 µg dvakrat na dan ni značilnih razlik.
Alfacalcidol alone was slightly superior to alendronate + plain Vitamin D + calcium after two years (MW = 0.5422; CI-LB = 0.4838; p = 0.0785).
Alfakalcidol v monoterapiji je bil po dveh letih nekoliko učinkovitejši od kombinacije alendronat + navaden vitamin D + kalcij (MW = 0,5422; spodnja meja intervala zaupanja = 0,4838; p = 0,0785).
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'.
Po dveh letih so ugotovili, da je bila kombinacija „alendronat + alfakalcidol“ veliko učinkovitejša pri zmanjšanju števila padcev od kombinacije „alendronat + navaden vitamin D + kalcij“ (Mann-Whitney (MW) = 0,5506; spodnja meja intervala zaupanja = 0,4937; p = 0,0407), ne pa tudi od „alfakalcidola v monoterapiji“.
Alfacalcidol is indicated in various conditions where there is a disturbance of calcium or phosphorus metabolism.
Alfakalcidol pa je indiciran za različna stanja, za katera je značilna motena presnova kalcija ali fosforja.
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
Poleg tega je predlagatelj trdil, da so te ugotovitve o alfakalcidolu v monoterapiji potrdili v preskušanjukombiniranega zdravljenja s 70 mg alendronata na teden in 1 µg alfakalcidola na dan (Tevabone), izvedenem po odobritvi dovoljenja za promet.
7 Bischoff-Ferrari HA, Willett WC, Wong JB, Stuck AE, Staehelin HB, Orav EJ, Thoma A, Kiel DP, Henschkowski J. Prevention of Nonvertebral Fractures with Oral Vitamin D and Dose Dependency.
J Am Med Assoc 2004b;291(16):1999-2006. 7 Bischoff-Ferrari HA, Willett WC, Wong JB, Stuck AE, Staehelin HB, Orav EJ, Thoma A, Kiel DP, Henschkowski J. Prevention of Nonvertebral Fractures with Oral Vitamin D and Dose Dependency.
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.
da dejstvo, da se število padcev v skupinah, ki sta prejemali kombinacijo „alendronat + alfakalcidol“ in „alfakalcidol v monoterapiji“, ni pomembno razlikovalo, dokazuje učinkovitost alfakalcidola pri zmanjšanju števila padcev tako v monoterapiji kot v kombinaciji z alendronatom.
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 po uporabi bodisi alfakalcidola ali kalcitriola v ustreznem in enakovrednem odmerku ni razlik v izpostavljenosti kalcitriolu v stacionarnem stanju.
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. Effects of Alfacalcidol on falls and balance in elderly people with Vitamin D deficiency.
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”.
Vendar pa se je strinjal, da se v poglavje 5.1 povzetka glavnih značilnosti zdravila vključijo naslednje informacije: „Nekatere klinične študije so pokazale, da alfakalcidol zmanjša tveganje za padce pri starejših.“ Navodilo za uporabo je treba ustrezno spremeniti.
The applicant further performed a meta-analysis of trials with alfacalcidol and calcitriol investigating fallers.
Predlagatelj je izvedel tudi metaanalizo preskušanj z alfakalcidolom in kalcitriolom, v katerih so proučevali posameznike, ki so padli.
Meta-analysis of trials on alfacalcidol and calcitriol investigating fallers
Metaanaliza preskušanj alfakalcidola in kalcitriola, v katerih so proučevali posameznike, ki so padli
The prandial state of the dog does not significantly affect the extent of its absorption.
Hranjenje psa ne vpliva občutno na obseg absorpcije.
A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Priporoča se veterinarski pregled 30 dni po zdravljenju, ker je morda pri nekaterih živalih potrebno zdravljenje ponoviti.
A distribution study determined that 14C-sarolaner-related residues were widely distributed to the tissues.
V študiji porazdelitve so ugotovili, da so ostanki, povezani s 14C-sarolanerjem široko porazdeljeni v tkivih.
Tablets can be administered with or without food.
Tablete se lahko daje s hrano ali brez nje.
The bioavailability of sarolaner following oral dosing was high at >85%.
Biološka uporabnost sarolanerja po peroralnem dajanju je visoka, znaša >85%.
To prevent children from accessing the product, only one chewable tablet at a time should be removed from the blister pack and only when required.
Da bi preprečili otrokom dostop do zdravila, se mora iz pretisnega omota vzeti le posamezna tableta naenkrat in samo, kadar je to potrebno.
Sarolaner was determined to have low clearance (0.12 ml/min/kg) and a moderate volume of distribution (2.81 l/kg).
Sarolaner ima nizek ledvični očistek (0,12 ml/min/kg) in zmeren volumen porazdelitve (2,81 l/kg).
EU/2/15/191/001-018
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/15/191/001-018