natgillin/translations-raw huggingface dataset:
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate)
Z enim vdihom dobite odmerek (odmerek, ki pride iz ustnika) 55 mikrogramov umeklidinija (to ustreza 65 mikrogramom umeklidinijevega bromida) in 22 mikrogramov vilanterola (v obliki trifenatata).
Wait to open the cover until you are ready to inhale your dose.
Pokrovček odprite šele, ko ste pripravljeni, da uporabite odmerek.
In Phase III, 6-month studies umeclidinium/vilanterol provided clinically meaningful improvements over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which were evident at 15 minutes following administration of the first dose (improvement over placebo by 112 ml (p <0.001*).
Šestmesečne študije III. faze so pokazale, da kombinacija umeklidinij/vilanterol v primerjavi s placebom klinično pomembno izboljša pljučno funkcijo (merjeno s forsiranim ekspiracijskim volumnom v 1. sekundi
How to store ANORO ELLIPTA
Shranjevanje zdravila ANORO ELLIPTA
Anaphylaxis, angioedema, and urticaria
slabost, hiperglikemija in hipokaliemija).
What ANORO ELLIPTA is used for
Za kaj uporabljamo zdravilo ANORO ELLIPTA
The ELLIPTA inhaler consists of a light grey body, red mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet.
ELLIPTA Inhalator je sestavljen iz svetlo sivega ohišja, rdečega pokrovčka ustnika in števca odmerkov.
No dose adjustment is required in patients with renal impairment.
Okvara ledvic Bolnikom z okvaro ledvic odmerka ni treba prilagoditi.
In addition, no clinically significant effects on cardiac rhythm were observed on 24-hour Holter monitoring in 53 patients with COPD who were treated with umeclidinium/vilanterol 55/22 micrograms once daily in
Poleg tega niso opazili klinično pomembnih vplivov na srčni ritem s 24-urno holtersko monitorizacijo pri
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj orofaringealna bolečina disfonija pogosti pogosti občasni
Your ANORO ELLIPTA inhaler carton contains
Škatla vašega zdravila ANORO ELLIPTA vsebuje
This leaflet
Na podtipu
• hoarseness.
• tresavica,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 55 micrograms/22 micrograms
VMESNA ZUNANJA OVOJNINA (BREZ MODREGA OKENCA - SAMO PAKIRANJE Z VEČ INHALATORJI)
• tremor
• hripavost.
Renal and urinary disorders Urinary retention Dysuria
Bolezni sečil zastoj urina dizurija obstrukcija iztočnega dela sečnega mehurja redki redki redki
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČ
Least squares mean
Povprečje po metodi najmanjših kvadratov
The total treatment period was 17 weeks.
Celotno obdobje zdravljenja je bilo 17 tednov.
The available data are insufficient to reach any conclusions.
Podatki, ki so na voljo, ne zadostujejo za sprejemanje kakršnihkoli zaključkov.
After first opening: 90 days.
Po prvem odprtju: 90 dni.
Date of first authorisation: 23/07/2012 Date of latest renewal: 6 April 2017
Datum prve odobritve: 23/07/2012 Datum zadnjega podaljšanja: 6. april 2017
Elderly (65 years of age and above)
Starejši bolniki (stari 65 let in več)
- Oral contraceptives (also called “hormonal contraceptives”).
- Peroralni kontraceptivi (imenovani tudi „hormonski kontraceptivi“).
The results in these adolescents were similar to those seen in the adult population.
Rezultati pri teh mladostnikih so bili podobni kot pri odrasli populaciji.
There appears to be an increased risk of falls, particularly in the elderly; the underlying reason is unclear.
Kaže, da je tveganje za padce večja, zlasti pri starejših; osnovni razlog ni jasen.
The safety and effectiveness are not yet known in this age group.
Varnost in učinkovitost v tej starostni skupini še nista znani.
It may also cause you to have unusual or extreme changes in behaviour or mood.
Povzroči lahko tudi neobičajne in izjemne spremembe vedenja ali razpoloženja.
Shake for at least 5 seconds before use.
Pred uporabo vsaj 5 sekund stresajte.
EXP After first opening: use within 90 days.
EXP Po prvem odprtju: uporabite v 90 dneh.
This was not statistically significant (p = 0.96).
To ni bilo statistično značilno (p = 0,96).
<10% decrease
< 10 % zmanjšanje
* See section 4.4
* Glejte poglavje 4.4
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for perampanel.
Mehanizem tveganja ni znan in podatki, ki so na voljo, ne izključujejo povečanega tveganja za perampanel.
You may experience confusion, agitation and aggressive behaviour.
Pojavijo se lahko zmedenost, vznemirjenost in agresivno vedenje.
Levels peaked at one hour and were 3.65 times the levels in plasma.
Najvišja raven je bila dosežena po eni uri in je bila 3,65-krat višja od ravni v plazmi.
It should not be chewed, crushed or split.
Ne sme se je žvečiti, drobiti ali deliti.
Of the 140 subjects who completed the Study 332, 114 subjects (81.4%) had entered the Extension phase.
Od 140 oseb, ki so zaključile študijo 332, je 114 oseb (81,4 %) vstopilo v podaljšano fazo.
If you have any suspension left in the bottle more than 90 days after it was first opened, you should not use it.
Če v plastenki ostane suspenzija dlje kot 90 dni po prvem odprtju, je ne smete uporabiti.
It may be taken with or without food, but preferably always under the same conditions.
Lahko se jemlje s hrano ali brez nje, vendar po možnosti vedno v enakih okoliščinah.
It has been given to you by your doctor to reduce the number of fits that you have.
Dal vam ga je vaš zdravnik, da bi se zmanjšalo število napadov, ki jih imate.
The mean average daily dose was 10.05 mg.
Srednji povprečen dnevni odmerek je bil 10,05 mg.
Study 332 included 22 adolescents between the ages of 12 and 18.
Študija 332 je zajela 22 mladostnikov starosti od 12 do 18 let.
The effect of these interactions on average steady state concentration is summarised in the following table.
Učinki teh interakcij na povprečno koncentracijo v stanju dinamičnega ravnovesja so povzeti v naslednji preglednici.
Of these, 14 patients (27%) reverted to adjunctive therapy in the following months.
Od teh je 14 bolnikov (27 %) v naslednjih mesecih prešlo nazaj na adjuvantno zdravilo.
*The colourants are:
*Barvila so:
It may be taken with or without food (see section 5.2).
Zdravilo se lahko vzame s hrano ali brez nje (glejte poglavje 5.2).
If this happens to you, do not drive or use any tools or machines.
Če opazite te učinke, ne vozite avta in ne uporabljajte orodja ali strojev.
Cognitive function
Kognitivne funkcije
Women of childbearing potential and contraception in males and females
Ženske v rodni dobi in kontracepcija pri moških in ženskah
In view of its long half-life, the effects caused by perampanel could be prolonged.
Ob upoštevanju dolgega razpolovnega časa se lahko učinki, ki jih povzroči perampanel, podaljšajo.
The cap fits properly when the PIBA is in place.
Zaporka se pravilno prilega, ko je PIBA nameščen.
You must talk to your doctor about the effect of your epilepsy on driving and using machines.
Z zdravnikom se morate posvetovati o učinkih vaše epilepsije na vožnjo in upravljanje s stroji.
The majority of these patients had a history of partial onset seizures.
Večina teh bolnikov je imela anamnezo parcialnih napadov.
This includes medicines obtained without a prescription and herbal medicines.
To vključuje tudi zdravila, ki ste jih kupili brez recepta, in zeliščna zdravila.
- Fycompa may make you more likely to fall over, particularly if you are an older person; this might be due to your illness.
- Zaradi zdravila Fycompa se lahko poveča možnost padca, zlasti, če ste starejša oseba; vzrok za to je lahko vaša bolezen.
Oral suspension White to off-white suspension
peroralna suspenzija bela do belkasta suspenzija
The tmax was delayed by approximately 1 hour compared to that under fasted conditions.
Tmax je bil podaljšan za približno 1 uro v primerjavi s tistim na tešče.
Nonclinical data reveal that perampanel was not genotoxic and had no carcinogenic potential.
Predklinični podatki kažejo, da perampanel ni genotoksičen in da nima kancerogenega potenciala.
The excretion into breast milk was measured in rats at 10 days post-partum.
Izločanje v materino mleko so izmerili pri podganah 10 dni po kotitvi.
The tablets cannot be split accurately as there is no break line.
Tablet ni mogoče natančno deliti, saj nimajo razdelilne zareze.
- Fycompa may make you aggressive, angry or violent.
- Zaradi zdravila Fycompa lahko postanete agresivni, jezni ali nasilni.
The precise mechanism by which perampanel exerts its antiepileptic effects in humans remains to be fully elucidated.
Natančen mehanizem, s katerim perampanel izvaja svoj antiepileptični učinek pri ljudeh, bo treba še dokončno razjasniti.
You should continue doing this for one month after stopping treatment.
tem nadaljujte še en mesec po prenehanju zdravljenja.
The following convention has been used for the classification of adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), not known (cannot be estimated from the available data).
Neželeni učinki so razvrščeni po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Decreased appetite Increased appetite
Presnovne in prehranske motnje zmanjšan apetit zvečan apetit
If signs and symptoms suggestive of these reactions appear, perampanel should be withdrawn immediately and an alternative treatment considered (as appropriate).
Če se pojavijo znaki in simptomi, ki nakazujejo te reakcije, je treba dajanje perampanela nemudoma prekiniti in razmisliti o drugačnem zdravljenju (kot je primerno).
Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal overexcitation.
Glutamat je primarni ekscitatoren nevrotransmitor v osrednjem živčnem sistemu, ki je vpleten v številnih nevroloških motnjah, ki jih povzroči prevelika nevronska ekscitacija.
There was no statistically significant difference between the treatment groups (p = 0.145).
Med tretiranima skupinama ni bilo statistično značilne razlike (p = 0,145).
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX22
Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX22
Study drug was given once per day.
Preučevano zdravilo so bolniki prejemali enkrat na dan.
These effects may also be seen when Fycompa is used in combination with other central nervous system (CNS) depressants.
Te učinke je mogoče videti tudi pri uporabi zdravila Fycompa v kombinaciji z drugimi zaviralci osrednjega živčnega sistema (OŽS).
For example, if you decide to take Fycompa with food, always take it that way.
Na primer, če se odločite, da boste jemali zdravilo Fycompa s hrano, ga vedno jemljite tako.
Effect of perampanel on CYP3A substrates
Učinek perampanela na substrate CYP3A
A meta-analysis of randomised placebo-controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Meta-analiza randomiziranih, s placebom kontroliranih preskušanj antiepileptičnih zdravil je pokazala tudi majhno povečanje tveganja za samomorilne misli in vedenje.
Suicidal ideation
Samomorilne misli
Cognitive function was assessed by the Cognitive Drug Research (CDR) System Global Cognition t-Score, which is a composite score derived from 5 domains testing Power of Attention, Continuity of Attention, Quality of Episodic Secondary Memory, Quality of Working Memory, and Speed of Memory.
Kognitivne funkcije so ocenjevali z rezultati vrednosti t globalnih kognitivnih funkcij sistema kognitivnih raziskav zdravil (CDR), ki je sestavljen rezultat, izpeljan iz 5 domen, s katerimi se testirali sposobnost pozornosti, stalnost pozornosti, kvaliteto epizodičnega sekundarnega spomina, kvaliteto delovnega spomina in hitrost spomina.
In these three trials, subjects had a mean duration of epilepsy of approximately 21.06 years.
V teh treh preskušanjih je epilepsija pri osebah povprečno trajala približno 21,06 let.
Subjects had partial-onset seizures with or without secondary generalisation and were not adequately controlled with one to three concomitant AEDs.
Osebe so doživele napade s parcialnim izvorom s sekundarno generalizacijo ali brez nje in niso bile pod ustreznim nadzorom s sočasno uporabo enega do treh AEZ.
The tablet should be swallowed whole with a glass of water.
Tableto je treba pogoltniti celo s kozarcem vode.
Fycompa contains sorbitol (E420); therefore patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Zdravilo Fycompa vsebuje sorbitol (E420); zato bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
Potrebna je splošna podporna nega bolnika, vključno z nadziranjem življenjskih znakov in opazovanjem kliničnega stanja bolnika.
Mood deteriorated following dosing of 12 mg/day only; the changes in mood were small and reflected a general lowering of alertness.
Slabšanje razpoloženja po odmerjanju samo 12 mg/dan; spremembe v razpoloženju so bile majhne in so odražale splošno slabšanje zbranosti.
Tell your doctor if you are taking hormonal contraceptives.
Povejte svojemu zdravniku, če jemljete hormonske kontraceptive.
Fycompa is available in packs of:
Zdravilo Fycompa je na voljo v pakiranjih po:
The population included 164 patients (perampanel N = 82, placebo N = 82).
Populacija je zajemala 164 bolnikov (n = 82 za perampanel in n = 82 za placebo).
In urine and faeces, recovered radioactivity was primarily composed of a mixture of oxidative and conjugated metabolites.
V urinu in blatu je bila rekuperirana radioaktivnost primarno sestavljena iz mešanice oksidativnih in konjugiranih presnovkov.
This effect should be taken into account and managed when adding or withdrawing these anti-epileptic drugs from a patient's treatment regimen.
Ta učinek je treba upoštevati in nadzorovati, kadar za zdravljenja bolnika ta antiepileptična zdravila dodamo ali odvzamemo.
Abuse potential
Možnost zlorabe
Activation of AMPA receptors by glutamate is thought to be responsible for most fast excitatory synaptic transmission in the brain.
Prevladuje mnenje, da je aktiviranje receptorjev AMPA z glutamatom odgovorno za večino hitrih ekscitatornih sinaptičnih prenosov v možganih.
Eisai Manufacturing Ltd. European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN United Kingdom
Eisai Manufacturing Ltd. European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN Velika Britanija
However, thoughts of harming others, physical assault or threatening behaviour were observed in some patients (<1% in perampanel clinical studies).
Vendar pa so pri nekaterih bolnikih opazili razmišljanja o poškodovanju drugih, fizičnemu napadu ali grozečemu vedenju (< 1 % v kliničnih študijah s perampanelom).
Felbamate has been shown to decrease the concentrations of some medicinal products and may also reduce perampanel concentrations.
Pokazalo se je, da felbamat znižuje koncentracije nekaterih zdravil in da lahko zmanjša tudi koncentracije perampanela.
The safety and efficacy of perampanel in children below 12 years of age have not been established yet.
Varnost in učinkovitost perampanela pri otrocih, starih do 12 let, še nista bili dokazani.
Contains sorbitol: see leaflet for further information.
Vsebuje sorbitol: glejte navodilo za uporabo za več informacij.
Patients and caregivers should be counselled to alert a healthcare professional immediately if significant changes in mood or patterns of behaviour are noted.
Bolnikom in negovalcem je treba svetovati, da takoj obvestijo zdravstvenega delavca, če se pojavijo velike spremembe v razpoloženju ali vedenjskih vzorcih.
It belongs to a group of medicines called anti-epileptics.
Spada v skupino zdravil, ki jih imenujemo antiepileptiki.
Behavioural and reproductive development of the offspring was not affected, but some parameters of physical development showed some delay, which is probably secondary to the pharmacology-based CNS effects of perampanel.
Vpliva na vedenjski in reprodukcijski razvoj mladičev ni bilo, vendar so nekateri parametri fizičnega razvoja pokazali rahlo upočasnitev, kar je verjetno posledica farmakoloških učinkov perampanela na OŽS.
A larger decrease in exposure of midazolam (or other sensitive CYP3A substrates) at higher Fycompa doses cannot be excluded.
Večje zmanjšanje izpostavljenosti midazolamu (ali drugih občutljivih substratih CYP3A) pri višjih odmerkih zdravila Fycompa ni mogoče izključiti.
After up to 52 weeks of treatment with perampanel (n = 114), no effect on bone growth was observed.
Po do 52 tednih zdravljenja s perampanelom (n = 114) niso ugotovili nikakršnega vpliva na rast kosti.
Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom
Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Velika Britanija
The cap should be replaced after each use.
Zaporko po vsaki uporabi spet namestite.
Your doctor may reduce your dose slowly to avoid your fits (seizures) coming back or getting worse.
Vaš zdravnik lahko vaš odmerek postopoma zmanjšuje, da prepreči ponovni pojav ali poslabšanje napadov (epileptičnih napadov).
It is not known whether the ingredients of Fycompa can pass into breast milk.
Ni znano, ali sestavine zdravila Fycompa prehajajo v materino mleko.
Between 85.3% and 89.1% of patients were taking two to three concomitant AEDs with or without concurrent vagal nerve stimulation.
Med 85,3 % in 89,1 % bolnikov je sočasno jemalo dve do tri AEZ s sočasno stimulacijo vagalnega živca ali brez nje.
Patients are advised not to drive a vehicle, operate complex machinery or engage in other potentially hazardous activities until it is known whether perampanel affects their ability to perform these tasks (see sections 4.4 and 4.5).
Bolnikom je treba odsvetovati vožnjo avtomobila, upravljanje z zahtevnimi stroji in opravljanje drugih dejavnosti, ki so lahko nevarne, dokler ni znano, ali perampanel vpliva na njihovo sposobnost opravljanja teh nalog (glejte poglavji 4.4 in 4.5).
Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Zato je treba bolnike opazovati za znake samomorilnih misli in vedenja in razmisliti o ustreznem zdravljenju.
Single missed dose: As perampanel has a long half-life, the patient should wait and take their next dose as scheduled.
En izpuščen odmerek: ker ima perampanel dolg razpolovni čas, naj bolnik počaka in vzame naslednji odmerek kot načrtovano.
Wash the oral syringe with clean water and dry thoroughly.
Brizgo izperite s čisto vodo in jo dobro osušite.
The number of perampanel subjects taking enzyme-inducing anti-epileptic medicinal products was small (n = 9).
Število oseb, ki so jemale perampanel in antiepileptična zdravila, ki spodbujajo encime, je bilo majhno (n = 9).
Most of the reported events were either mild or moderate and patients recovered either spontaneously or with dose adjustment.
Večina poročanih primerov je bila blaga ali zmerna in so izzveneli spontano ali s prilagoditvijo odmerka.
Gait disturbance Fatigue
Splošne težave motnje hoje utrujenost
Discuss with your doctor what may be appropriate contraception for you.
Posvetujte se z zdravnikom, katera kontracepcija je za vas najprimernejša.
- It is used to treat fits that affect one part of your brain (called a “partial seizure”).
- Uporablja se za zdravljenje napadov, ki prizadenejo del vaših možganov (imenovanih „parcialni napadi“).
Stop using perampanel if you develop these symptoms and contact your doctor or seek medical attention immediately.
Ne uporabljajte perampanela, če se pri vas pojavijo simptomi, in se posvetujte z zdravnikom ali nemudoma poiščite zdravniško pomoč.
In all three trials, the Titration Phase was followed by a Maintenance Phase that lasted 13 weeks, during which patients were to remain on a stable dose of perampanel.
V vseh treh preskušanjih je fazi titriranja sledila faza vzdrževanja, ki je trajala 13 tednov, v kateri so bolniki prejemali stabilni odmerek perampanela.
Analysis of safety information in 905 perampanel-treated elderly subjects (in double-blind studies conducted in non-epilepsy indications) revealed no age-related differences in the safety profile.
Analiza podatkov o varnosti pri 905 starejših bolnikih, zdravljenih s perampanelom (v dvojno slepih študijah, opravljenih za indikacijo, ki ni epilepsija), ni razkrila nobenih od starosti odvisnih razlik pri varnostnem profilu.
Swallow the tablet whole with a glass of water.
Tableto vzemite celo s kozarcem vode.
You can take Fycompa with or without food.
Zdravilo Fycompa lahko vzamete s hrano ali brez nje.
Before taking this medicine you should tell your doctor if you have a history of alcoholism or drug dependence.
Preden boste vzeli to zdravilo, morate zdravniku povedati, če imate v anamnezi alkoholizem ali odvisnost od drugih snovi.
Patients' response should be monitored when they are switching from concomitant non-inducer anti-epileptic medicinal products to enzyme inducing medicinal products and vice versa.
Odziv bolnikov je treba spremljati, ko preidejo iz sočasne uporabe antiepileptičnih zdravil, ki ne spodbujajo encima, na zdravila, ki spodbujajo encim, in obratno.
Data from in vitro studies indicate that perampanel is approximately 95% bound to plasma proteins.
Podatki iz študij in vitro nakazujejo, da se perampanel veže na beljakovine plazme v približno 95 %.
Clinical studies of Fycompa in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
V klinične študije z zdravilom Fycompa za epilepsijo ni bilo vključenih dovolj oseb, starih 65 let in več, da bi lahko ugotovili, ali se odzivajo drugače kot mlajši bolniki.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fycompa therapy taking into account the benefit of breast--feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Fycompa, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Carbamazepine 2.75 fold decrease
karbamazepin 2,75-kratno zmanjšanje
The effects of perampanel on complex tasks such as driving ability were additive or supra-additive to the impairment effects of alcohol.
Učinki perampanela na zahtevne naloge, denimo sposobnost vožnje, so bili aditivni ali supra-aditivni na učinke alkohola.
There are limited amounts of data (less than 300 pregnancy outcomes) from the use of perampanel in pregnant women.
Podatki o uporabi perampanela pri nosečnicah so omejeni (manj kot 300 izidov nosečnosti).
In a report of an intentional overdose that could have resulted in a dose up to 264 mg, the patient experienced events of altered mental status, agitation and aggressive behaviour and recovered without sequelae.
Pri namernem prevelikem odmerjanju, ki bi ustrezal odmerku do 264 mg, je bolnik doživel dogodke kot so spremenjeno duševno stanje, vznemirjenost in agresivno vedenje, nato pa je brez posledic okreval.
The three pivotal double-blind placebo-controlled phase 3 studies included 143 adolescents between the ages of 12 and 18.
Tri osrednje dvojno slepe, s placebom kontrolirane študije 3. faze so vključevale 143 mladostnikov, starih med 12 in 18 let.
Switching between the tablet and suspension formulation should be done with caution (see section 5.2).
Pri prehodu med tabletami in suspenzijo je potrebna previdnost (glejte poglavje 5.2).