natgillin/translations-raw huggingface dataset:
Steglatro can only be obtained with a prescription.
Predpisovanje in izdaja zdravila je le na recept.
This summary was last updated in 06-2014.
Povzetek je bil nazadnje posodobljen 6-2014.
Nausea is more common in women than in men.
Slabost je pogostejša pri ženskah kot pri moških.
What measures are being taken to ensure the safe and effective use of Xyrem?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xyrem?
The European Commission granted a marketing authorisation valid throughout the European Union for Xyrem on 13 October 2005.
Evropska komisija je dovoljenje za promet z zdravilom Xyrem, veljavno po vsej Evropski uniji, izdala 13. oktobra 2005.
The precise way in which it works is not known, but it is thought to attach to receptor molecules on the surface of some cells in the brain.
Natančen način njegovega delovanja ni znan, vendar se najverjetneje veže na receptorske molekule na površini nekaterih celic v možganih.
This improves the symptoms of narcolepsy.
To izboljša simptome narkolepsije.
The second dose is taken 2.5 to 4 hours later.
Drugi odmerek se vzame 2,5 do 4 ure pozneje.
Other information about Xyrem:
Druge informacije o zdravilu Xyrem:
The full EPAR for Xyrem can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Xyrem je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This leads to changes in the activity of the brain, bringing about ‘delta' (slow) brain waves and night-time sleep.
To povzroči spremembe aktivnosti možganov ter pospeši „delta“ (počasne) možganske valove in nočni spanec.
Xyrem was more effective than placebo in reducing symptoms.
Zdravilo Xyrem je bilo pri zmanjševanju simptomov učinkovitejše od placeba.
The dose is then adjusted at one- to two-week intervals depending on the patient's response.
Odmerek se nato prilagaja v eno- do dvotedenskih intervalih, odvisno od bolnikovega odziva.
The data obtained in the fibromyalgia studies did not support the use of Xyrem in this condition in the European population.
Podatki, zbrani s študijami fibromialgije, niso podprli uporabe zdravila Xyrem pri tej bolezni evropske populacije.
The medicine can only be obtained with a special prescription.
Izdaja zdravilo je le na poseben recept.
Cataplexy can sometimes cause a patient to collapse.
Katapleksija lahko včasih povzroči, da se bolnik zgrudi.
Xyrem can also cause respiratory depression (inhibition of breathing).
Zdravilo Xyrem lahko povzroči tudi respiratorno depresijo (oteženo dihanje).
The main measure of effectiveness was the change in daytime sleepiness.
Glavno merilo učinkovitosti je bila sprememba dnevne zaspanosti.
This document is a summary of the European Public Assessment Report (EPAR) for Xyrem.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xyrem.
The study measured the number of cataplexy attacks over two weeks.
V študiji so merili število kataplektičnih napadov v obdobju dveh tednov.
What benefit has Xyrem shown during the studies?
Kakšne koristi je zdravilo Xyrem izkazalo med študijami?
The first dose of the day is taken at bedtime, at least two to three hours after food.
Prvi dnevni odmerek se vzame pred spanjem, najmanj dve do tri ure po obroku.
Cataplexy is a symptom of narcolepsy involving sudden muscle weakness in response to an emotional reaction such as anger, fear, joy, laughter or surprise.
Katapleksija je simptom narkolepsije, ki se kaže kot nenadna mišična šibkost kot odgovor na čustveno reakcijo, kot so na primer jeza, strah, veselje, smeh ali presenečenje.
Narcolepsy is a sleep disorder that causes excessive daytime sleepiness.
Narkolepsija je motnja spanja, ki povzroča prekomerno dnevno zaspanost.
A risk management plan has been developed to ensure that Xyrem is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Xyrem je bil pripravljen načrt obvladovanja tveganj.
Patients taking Xyrem should avoid alcohol, as it can increase Xyrem's effects.
Bolniki, ki jemljejo zdravilo Xyrem, se morajo izogibati alkoholu, saj lahko ta poveča učinke zdravila Xyrem.
The effects of Xyrem in narcolepsy and cataplexy have been studied in 707 patients in four studies.
Učinke zdravila Xyrem pri narkolepsiji in katapleksiji so proučevali v štirih študijah s 707 bolniki.
For more information about treatment with Xyrem, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Xyrem preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Both doses should be prepared at the same time before the patient goes to bed.
Oba odmerka je treba pripraviti hkrati, preden bolnik leže zvečer k počitku.
Although the 9-g dose was the most effective, it was linked to high levels of side effects, so the Committee recommended a starting dose of 4.5 g per day.
Čeprav je bil 9-gramski odmerek najbolj učinkovit, je bil povezan z mnogimi neželenimi učinki, zato je odbor priporočil začetni odmerek 4,5 g dnevno.
Xyrem is an oral solution that contains the active substance sodium oxybate (500 mg/ml).
Zdravilo Xyrem je peroralna raztopina, ki vsebuje zdravilno učinkovino natrijev oksibat (500 mg/ml).
Fibromyalgia is a disease of unknown origin causing long-lasting, widespread pain and painful responses to touch.
Fibromialgija je bolezen neznanega izvora, ki povzroča dolgotrajno razširjeno bolečino in bolečino ob dotiku.
The company that makes Xyrem will minimise the risk of abuse of Xyrem by providing educational materials to healthcare workers and patients, strictly controlling the distribution of the medicine, and monitoring its use.
Družba, ki izdeluje zdravilo Xyrem, bo čim bolj zmanjšala tveganje za zlorabo zdravila Xyrem, tako da bo zdravstvenim delavcem in bolnikom priskrbela izobraževalno gradivo, strogo nadzorovala distribucijo zdravila in spremljala njegovo uporabo.
The main measure of effectiveness was based on reduction of pain severity and improvement in function.
Glavno merilo učinkovitosti je bilo ublažitev bolečine in izboljšanje zmogljivosti.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xyrem.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Before taking the medicine, the patient should dissolve the dose in water to make up a drink.
Pred jemanjem zdravila mora bolnik odmerek raztopiti v vodi, da dobi napitek.
The effects of Xyrem have also been studied in fibromyalgia patients with moderate to severe symptoms in two short-term (12-week) studies in 1,121 patients, and one long-term (up to nine months) study in 560 patients.
Učinke zdravila Xyrem so proučevali tudi pri 1 121 bolnikih s fibromialgijo z zmernimi do hudimi simptomi v dveh kratkotrajnih (12-tedenskih) študijah in v eni dolgoročni študiji (do devet mesecev) pri 560 bolnikih.
Xyrem must not be used in patients with major depression, in patients with ‘succinic semialdehyde dehydrogenase deficiency' (a rare metabolic disease), or in patients being treated with opioids (such as some painkillers) or barbiturates (such as some anaesthetics and medicines used to prevent seizures).
Zdravila Xyrem ne smejo uporabljati bolniki s težjo depresijo, „zmanjšanim delovanjem encima sukcinat-semialdehid-dehidrogenaze“ (redko presnovno boleznijo) ali bolniki, ki se zdravijo z opioidi (kot so nekatera zdravila za lajšanje bolečine) ali barbiturati (kot so nekateri anestetiki in zdravila, ki se uporabljajo za preprečevanje napadov).
The maximum daily dose is 9 g. Patients should usually start with two doses of 2.25 g (4.5 ml) per day.
Največji dnevni odmerek je 9 g. Bolniki običajno začnejo z dvema odmerkoma po 2,25 g (4,5 ml) dnevno.
The Committee recommended that Xyrem be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Xyrem izda dovoljenje za promet.
The most common side effects with Xyrem (seen in more than 1 patient in 10) are dizziness, headache and nausea (feeling sick).
Najpogostejši neželeni učinki zdravila Xyrem (opaženi pri več kot 1 od 10 bolnikov) so omotica, glavobol in navzeja (slabost).
What is the risk associated with Xyrem?
Kakšna tveganja so povezana z zdravilom Xyrem?
Xyrem is used to treat adults who have narcolepsy with cataplexy.
Zdravilo Xyrem se uporablja za zdravljenje odraslih, ki imajo narkolepsijo s katapleksijo.
In the first study, a daily dose of 9 g reduced the number of cataplexy attacks by 16.1 (from 23.5 to 8.7) per week, compared with a fall of 4.3 per week in the patients taking placebo.
V prvi študiji je dnevni 9gramski odmerek zmanjšal število kataplektičnih napadov za 16,1 (s 23,5 na 8,7) tedensko, medtem ko je bilo tedensko zmanjšanje pri bolnikih, ki so jemali placebo, za 4,3.
Xyrem treatment should be started and given under the guidance of a doctor who has experience in the treatment of sleep disorders.
Zdravljenje z zdravilom Xyrem je treba uvesti in ga izvajati pod vodstvom zdravnika, ki ima izkušnje z zdravljenjem motenj spanja.
Since the effective dose is close to the dose at which side effects become serious, increases in dose must be carried out strictly and under the supervision of a doctor specialised in the treatment of sleep disorders.
Ker je učinkovit odmerek blizu odmerka, pri katerem postanejo neželeni učinki resni, je treba povečanja odmerka izvajati strogo in pod nadzorom zdravnika, ki je posebej usposobljen za zdravljenje motenj spanja.
When taken at bedtime, Xyrem increases deep sleep and increases the amount of time spent asleep at night, whilst reducing the number of sleeping periods during the day.
Zdravilo Xyrem, vzeto pred spanjem, poveča globoko spanje in količino nočnega spanca, pri tem pa zmanjša pogostost spanja podnevi.
Xyrem is given at a dose of 4.5 to 9 g per day in two equally divided doses.
Zdravilo Xyrem se daje v odmerku od 4,5 do 9 g dnevno v dveh enakih odmerkih.
The first study (136 patients) examined the effects of Xyrem on the number of cataplexy attacks over four weeks of treatment.
V prvi študiji (pri 136 bolnikih) so proučevali učinke zdravila Xyrem na število kataplektičnih napadov v štirih tednih zdravljenja.
The active substance in Xyrem, sodium oxybate, is a central nervous system depressant.
Zdravilna učinkovina zdravila Xyrem, natrijev oksibat, je zaviralec osrednjega živčnega sistema.
Xyrem also reduced excessive daytime sleepiness in patients who continued to take modafinil, as well as in those who took Xyrem alone.
Zdravilo Xyrem je tudi zmanjšalo prekomerno dnevno zaspanost pri bolnikih, ki so nadaljevali jemanje modafinila, kot tudi pri bolnikih, ki so jemali samo zdravilo Xyrem.
Why has Xyrem been approved?
Zakaj je bilo zdravilo Xyrem odobreno?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xyrem, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The other two studies (516 patients) examined the effects of Xyrem on excessive daytime sleepiness and other symptoms of narcolepsy, either taken alone or as an add-on to the patient's existing dose of modafinil (a stimulant medicine used to treat narcolepsy).
V drugih dveh študijah (pri 516 bolnikih) so proučevali učinke zdravila Xyrem na prekomerno dnevno zaspanost in na druge simptome narkolepsije, pri čemer se je zdravilo jemalo samostojno ali kot dodatek k bolnikovemu obstoječemu odmerku modafinila (stimulansa, ki se uporablja za zdravljenje narkolepsije).
The CHMP decided that Xyrem's benefits are greater than its risks.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Xyrem večje od z njim povezanih tveganj.
Because sodium oxybate can be abused, doctors should check for a history of or susceptibility to drug abuse before treatment, and monitor for misuse and abuse during treatment.
Ker je natrijev oksibat mogoče zlorabiti, morajo zdravniki pred zdravljenjem preveriti morebitne zlorabe zdravil v preteklosti ali dovzetnost za zlorabo, med zdravljenjem pa spremljati morebitno napačno uporabo in zlorabo zdravila.
Patients are also advised against taking alcohol while on treatment with Xyrem.
Bolnikom se odsvetuje uporaba alkohola med zdravljenjem z zdravilom Xyrem.
In all of the studies, Xyrem was given at a daily dose between 3 and 9 g and was compared with placebo (a dummy treatment).
V vseh študijah so bolniki zdravilo Xyrem prejemali v dnevnem odmerku med 3 in 9 g, pri čemer so njegov učinek primerjali s placebom (zdravilom brez zdravilne učinkovine).
For the full list of all side effects reported with Xyrem, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Xyrem, glejte navodilo za uporabo.
The dose of Xyrem should also be reduced by a fifth if patients are taking the medicine valproate for another condition at the same time as they are taking Xyrem.
Odmerek zdravila Xyrem je treba zmanjšati za petino, če bolnik sočasno jemlje zdravilo valproat za katero drugo bolezen.
The second study showed that Xyrem continued to prevent cataplexy attacks after long-term treatment: there was no change over two weeks in the number of attacks in the patients continuing to take Xyrem, compared to an increase of 21.0 attacks in those switching to placebo.
Druga študija je pokazala, da je zdravilo Xyrem po dolgoročnem zdravljenju še naprej preprečevalo kataplektične napade: pri bolnikih, ki so nadaljevali jemanje zdravila Xyrem, v dveh tednih ni bilo spremembe v številu napadov, medtem ko se je pri bolnikih, ki so prešli na placebo, število napadov povečalo za 21.
Because sodium oxybate can be abused, doctors must carefully monitor patients using Xyrem.
Ker je natrijev oksibat mogoče zlorabiti, morajo zdravniki bolnike, ki uporabljajo zdravilo Xyrem, skrbno nadzorovati.
Xyrem is supplied with a measuring device and a cup.
Zdravilu Xyrem sta priloženi merilna naprava in merica.
The second study, including 56 patients who had been taking Xyrem for at least six months, compared the effects of continuing to take Xyrem at the same dose as before, with the effects of switching to placebo.
V drugi študiji s 56 bolniki, ki so jemali zdravilo Xyrem najmanj šest mesecev, so primerjali učinke nadaljnjega jemanja zdravila Xyrem v nespremenjenem odmerku z učinki pri prehodu na placebo.
Patients who have problems with their kidneys should consider a low sodium diet.
Za bolnike, ki imajo težave z ledvicami, se priporoča dieta z manj natrija.
How does Xyrem work?
Kako zdravilo Xyrem deluje?
What is Xyrem used for?
Za kaj se zdravilo Xyrem uporablja?
How has Xyrem been studied?
Kako je bilo zdravilo Xyrem raziskano?
What is Xyrem?
Kaj je zdravilo Xyrem?
The starting dose should be halved in patients who have problems with their liver.
Pri bolnikih, ki imajo težave z jetri, je treba začetni odmerek razpoloviti.
How is Xyrem used?
Kako se zdravilo Xyrem uporablja?
EXP After opening: 1 month
EXP Po odprtju: 1 mesec
• You can also mix your medicine with water in a small glass.
• Lahko pa zdravilo zmešate z vodo v majhnem kozarcu.
Stir and drink all of the mixture.
Premešajte in izpijte celotno mešanico.
• Treatment usually starts with a low dose.
• Zdravljenje se običajno začne z nizkim odmerkom.
It is not known if this occurs in humans.
Ni znano, ali do tega prihaja tudi pri ljudeh.
Each bottle contains 250 capsules.
Ena steklenica vsebuje 250 kapsul.
• Difficulty in sleeping
• težave s spanjem,
They may respond to a dose reduction.
Le-ti se utegnejo odzvati na zmanjšanje odmerka.
D-90429 Nuremberg Germany
D-90429 Nuremberg
• A few tiny bubbles are not important and will not affect your dose in any way.
• Prisotnost nekaj manjših mehurčkov ni pomembna in na noben način ne bo vplivala na odmerjanje.
• Seeing things that are not there (hallucinations)
• vidna zaznava nečesa, česar v resnici ni tam (halucinacije)
Contains sodium benzoate (E 211).
Vsebuje natrijev benzoat (E 211).
Do not refrigerate or freeze.
Ne shranjujte v hladilniku ali zamrzujte.
Your doctor will regularly check if the medicine is working for you.
Zdravnik bo redno preverjal, ali je zdravilo pri vas učinkovito.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo.
In addition, a post-hoc definition of response is provided in the same table.
Poleg tega ista preglednica podaja post-hoc opredelitev odziva.
E-08210 Barberà del Vallès, Barcelona Spain
E-08210 Barberà del Vallès, Barcelona Španija
Only for carton box: PC:
Samo za kartonsko škatlo: PC:
Therefore, the clinical benefit of rivastigmine should be reassessed on a regular basis, especially for patients treated at doses less than 3 mg twice a day.
Zato moramo klinično koristnost rivastigmina redno ponovno ocenjevati, posebno pri bolnikih, zdravljenih z odmerki, ki so manjši od 3 mg dvakrat na dan.
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Zdravnik vam bo povedal, ali s svojo boleznijo lahko varno upravljate vozila in stroje.
Discontinuation should also be considered when evidence of a therapeutic effect is no longer present.
Prekinitev tudi pretehtamo, kadar ni več znakov terapevtskega učinka.
Date of first authorisation: 11/12/2009 Date of first renewal: 11/07/2014
Datum prve odobritve: 11.12.2009 Datum prvega podaljšanja: 11.07.2014
Absolute bioavailability after a 3 mg dose is about 36%±13%.
Absolutna biološka uporabnost po odmerku 3 mg je okrog 36 % ± 13 %.
Patients with Clinically Significant Response (%) Intent to Treat
Bolniki s klinično pomembnim odzivom (%)
Peak plasma concentrations are reached in approximately 1 hour.
Največjo koncentracijo v plazmi doseže približno v 1 uri.
Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product by the patient.
Zdravljenje z rivastigminom se sme začeti le, če je na voljo negovalec, ki bo redno spremljal bolnikovo jemanje zdravila.
1 Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate.
1 ANCOVA z zdravljenjem in državo kot faktorjema in izhodiščnim ADAS-Cog kot sospremenljivko.
• Urinary incontinence (inability to retain adequate urine)
• urinska inkontinenca (nezmožnost zadrževanja urina).
50 ml or 120 ml bottle.
50 ali 120-mililitrska steklenica.
Not known (frequency cannot be estimated from the available data) • Allergic reaction where the patch was used, such as blisters or skin inflammation
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) • alergijska reakcija na mestu uporabe obliža, kot je pojav mehurjev ali vnete kože.
In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
V primeru hudega bruhanja v povezavi z zdravljenjem z rivastigminom je treba ustrezno prilagoditi odmerek, kot je priporočeno v poglavju 4.2.
Preparing the bottle and syringe
Pripravljanje steklenice in brizge
Π.T.Χατζηγeωργίου εταιρεία Ltd Γιλντίζ 31-3042 Λεμεσός Τηλέφωνο: 00357 25372425 Φαξ: 00357 25376400
Π.T.Χατζηγεωργίου εταιρεία Ltd Γιλντίζ 31-3042 Λεμεσός Τηλέfφνο: 00357 25372425 Φαξ: 00357 25376400
If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention.
Če ste omotični ali zaspani, ne smete upravljati motornih vozil, strojev ali opravljati nalog, ki zahtevajo pozornost.
Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment 24 hours after the overdose.
Večina primerov nenamernega prevelikega odmerjanja ni bila povezana z nikakršnimi kliničnimi znaki ali simptomi in skoraj vsi ti bolniki so nadaljevali zdravljenje z rivastigminom v 24 urah po prevelikem odmerjanju.
Treatment effect has not been studied in placebo-controlled trials beyond 6 months.
Terapevtskega učinka niso proučevali v preskušanjih, kontroliranih s placebom, daljših od 6 mesecev.
• Then, remove the syringe from the bottle.
• Nato lahko izvlečete brizgo iz steklenice.
Filling the syringe • Pull the plunger upwards until it reaches the right mark for the dose that your doctor has prescribed.
• Bat povlecite navzgor, dokler ne doseže ustrezne oznake za odmerek, ki vam ga je predpisal zdravnik.
Such events appeared to occur particularly after dose increments or high doses of rivastigmine.
Do takih dogodkov je prišlo predvsem po povečevanju odmerka ali visokih odmerkih rivastigmina.
250 hard capsules
250 trdih kapsul
Detailed information of this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
• Feeling tired or weak
• občutek utrujenosti ali šibkosti,
If after 3 months of maintenance dose treatment the patient's rate of decline in dementia symptoms is not altered favourably, the treatment should be discontinued.
Če se po treh mesecih vzdrževalnega odmerka slabšanje simptomov demence ne spremeni v bolnikovo korist, je treba zdravljenje prekiniti.
However, rivastigmine may be used in this patient population and close monitoring is necessary.
Vendar se zdravilo Rivastigmin HEXAL v tej populaciji bolnikov lahko uporabi in potrebno je natančno spremljanje.
• To benefit from your medicine, take it every day.
• Da vam bo zdravilo pomagalo, ga morate jemati en dan.
Allergic contact dermatitis should be suspected if application site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g. increasing erythema, oedema, papules, vesicles) and if symptoms do not significantly improve within 48 hours after patch removal.
Sum na alergijski kontaktni dermatitis je treba postaviti, če se reakcija na mestu apliciranja razširi preko robov obliža, če obstajajo dokazi intenzivnejše lokalne reakcije (npr. povečan eritem, edem, papule, vezikli) in če se simptomi bistveno ne izboljšajo v 48 urah po odstranitvi transdermalnega obliža.
See leaflet for further information.
Za več podatkov glejte navodilo.
Repeated-dose toxicity studies in rats, mice and dogs revealed only effects associated with an exaggerated pharmacological action.
Raziskave toksičnosti ponavljajočih se odmerkov na podganah, miših in psih so razkrile le učinke, povezane s pretiranim farmakološkim delovanjem.
In view of its pharmacodynamic effects and possible additive effects, rivastigmine should not be given concomitantly with other cholinomimetic substances.
Zaradi njegovih farmakodinamičnih učinkov in možnih aditivnih učinkov se rivastigmina ne sme uporabljati skupaj z drugimi holinomimetičnimi snovmi.
- if you suffer from trembling.
- če imate težave s tresenjem,
ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
ITT: namen zdraviti (Intent-To-Treat); RDO: upoštevani izpadli primeri (Retrieved Drop Outs); LOCF: zadnje opazovanje preneseno naprej (Last Observation Carried Forward)
28 hard capsules 56 hard capsules 112 hard capsules
28 trdih kapsul 56 trdih kapsul 112 trdih kapsul
No clinical data on exposed pregnancies are available.
Ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
Your doctor will also monitor your weight whilst you are taking this medicine.
Zdravnik bo med jemanjem tega zdravila prav tako spremljal vašo telesno maso.