natgillin/translations-raw huggingface dataset:
Specifically, the SAG was asked to clarify the definition of a mood stabiliser and the need for a medicinal product to act on both poles of the disorders.
Skupina SAG je bila posebej pozvana, da bi pojasnila opredelitev stabilizatorja razpoloženja in potrebe po zdravilu, ki bi bilo učinkovito pri obeh polih motnje.
• if you are already taking medicine that contains lamotrigine.
• če že jemljete kakšno zdravilo, ki vsebuje lamotrigin.
Lamictal can also affect the way hormonal contraceptives work, although it's unlikely to make them less effective.
Zdravilo Lamictal lahko tudi vpliva na delovanje hormonske kontracepcije, čeprav ni verjetno, da bi zmanjšalo njeno učinkovitost.
If, based on clinical need, a decision to treat is nevertheless taken, see sections 4.4, 5.1 and 5.2.
Če se glede na klinične potrebe vseeno odločite za takšno zdravljenje, glejte poglavji 5.1 in 5.2.
In some breast-fed infants, the serum concentrations of lamotrigine reached levels at which pharmacological effects may occur.
Pri nekaterih dojenčkih je serumska koncentracija lamotrigina dosegla raven, pri kateri se lahko pojavijo farmakološki učinki.
Nevertheless differences exist with respect to the precise wording of the epilepsy indication, restriction of age-categories, seizure types, dose recommendations and interactions.
Kljub temu pa obstajajo razlike pri besedilu indikacije za epilepsijo, omejitve starostnih skupin, vrst napadov, priporočil za odmerjanje in interakcij.
If you suddenly stop taking Lamictal, your epilepsy may come back or get worse.
Če zdravilo Lamictal nehate jemati nenadoma, se vam lahko epilepsija povrne ali poslabša.
The CHMP was concerned about the suitability of lamotrigine used as mood stabiliser.
CHMP je izrazil pomisleke glede primernosti uporabe lamotrigina kot stabilizatorja razpoloženja.
• a sore throat, or more infections (such as colds) than usual.
• vnetje žrela ali več okužb (npr. prehladov) kot ponavadi.
Children and adolescents below 18 years
Otroci in mladostniki do 18. leta
Important information about some of the ingredients of Lamictal Lamictal tablets contain small amounts of a sugar called lactose.
Pomembne informacije o nekaterih sestavinah zdravila Lamictal Tablete Lamictal vsebujejo majhno količino sladkorja, imenovanega laktoza.
Tell your doctor or pharmacist if you're taking any other medicines, if you've taken any recently, or if you start taking new ones - these include herbal medicines or other medicines you bought without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete, če ste pred kratkim jemali, ali če začnete na novo jemati katerokoli zdravilo - to velja tudi za zeliščne pripravke in zdravila, ki ste jih dobili brez recepta.
- Quality aspects
- Vidiki kakovosti
Also, the current standard treatments for Bipolar disorder and the feasibility of monotherapy were discussed.
Prav tako so obravnavali sedanje standardne načine zdravljenja bipolarne motnje in izvedljivost monoterapije.
If anyone takes too much Lamictal:
Če kdorkoli vzame preveč zdravila Lamictal:
dry mouth
suha usta.
• Put the tablet in a glass with at least enough water to cover the whole tablet.
• Dajte tableto v kozarec, v katerem mora biti vsaj toliko vode, da prekrije celo tableto.
Risk related to lamotrigine
Tveganje, povezano z lamotriginom
The main areas of disharmony of the existing Summary of Product Characteristics concerned the Therapeutic Indications.
Neenotnost obstoječega povzetka glavnih značilnosti zdravila se je nanašala predvsem na terapevtske indikacije.
If therapy with Lamictal is considered necessary during pregnancy, the lowest possible therapeutic dose is recommended.
Če je zdravljenje z Lamictalom med nosečnostjo nujno, je priporočljivo uporabiti najmanjši možni terapevtski odmerek.
* Dose may be increased to 400 mg/day as needed
* Odmerek se lahko zviša na 400 mg/dan, če je potrebno.
• pain in your back or joints, or elsewhere.
• bolečine v hrbtu, sklepih ali drugje
Only about 2% of lamotrigine-related material is excreted in faeces.
Samo okoli 2 % snovi, ki izvirajo iz lamotrigina, se izloči v blatu.
Available data from a number of studies suggest the incidence of rashes associated with hospitalisation in epileptic children is from 1 in 300 to 1 in 100.
Razpoložljivi podatki številnih študij kažejo, da je incidenca izpuščajev, povezanih s sprejemom v bolnišnico, pri otrocih z epilepsijo od 1 na 300 do 1 na 100.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LAMICTAL AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA LAMICTAL IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
• a high temperature (fever)
• zvišana telesna temperatura (vročina)
Caution is also required when treating patients with a history of allergy or rash to other AEDs as the frequency of non-serious rash after treatment with lamotrigine was approximately three times higher in these patients than in those without such history.
Previdnost je potrebna tudi pri zdravljenju bolnikov z anamnezo alergije ali izpuščaja pri uporabi drugih antiepileptikov, kajti pogostnost ne-resnih izpuščajev je bila pri takšnih bolnikih po zdravljenju z lamotriginom približno trikrat večja kot pri bolnikih brez takšne anamneze.
Treatment is initiated as monotherapy, but almost inevitably soon other antiepileptics will be added to control the symptoms.
Zdravljenje se začne kot monoterapija, vendar se za nadzor simptomov skoraj neizogibno kmalu dodajo drugi antiepileptiki.
The maintenance effect on typical absence seizures remains unclear, thus a warning will be included in the SPC stating that “In children taking lamotrigine for the treament of typical absence seizures, efficacy may not be maintained in all patients”.
Učinek vzdrževanja pri tipičnih napadih odsotnosti še vedno ni jasen, zato bo v povzetek glavnih značilnosti zdravila vključeno opozorilo „Pri otrocih, pri katerih se lamotrigin uporablja za zdravljenje tipičnih napadov odsotnosti, učinkovitosti morda ne bo mogoče ohraniti pri vseh bolnikih“.
WHAT LAMICTAL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO LAMICTAL IN ZA KAJ GA UPORABLJAMO
• a disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation)
• motnja strjevanja krvi, ki lahko povzroči nepričakovane krvavitve ali podplutbe (diseminirana intravaskularna koagulacija)
Folic acid deficiency is assumed to be associated with an enhanced risk of congenital malformations in animals as well as in humans.
Pomanjkanje folne kisline je domnevno povezano z večjim tveganjem za nastanek kongenitalnih malformacij pri živalih in pri ljudeh.
If necessary, the dose should be adapted to maintain the lamotrigine serum concentration at the same level as before pregnancy, or adapted according to clinical response.
Če je potrebno, odmerek prilagodite, da bo ostala serumska koncentracija lamotrigina enaka kot pred nosečnostjo, ali ga prilagodite glede na klinični odziv.
Data indicate that lamotrigine passes into breast milk.
Podatki kažejo, da lamotrigin prehaja v materino mleko.
The potential benefits of breast-feeding should be weighed against the potential risk of adverse effects occurring in the infant.
Možne koristi dojenja je treba pretehtati v primerjavi z možnim tveganjem za neželene učinke pri dojenčku.
The age range will be modified considering that patients aged 12 years fall within the definition of adolescents.
Starostni razpon bo spremenjen ob upoštevanju dejstva, da so bolniki, stari 12 let, opredeljeni kot mladostniki.
• confusion or agitation
• zmedenost ali vznemirjenost
Lamictal tablets contain lactose monohydrate.
Lamictal tablete vsebujejo laktozo monohidrat.
The apparent plasma clearance in healthy subjects is approximately 30 mL/min.
Navidezni plazemski očistek pri zdravih preiskovancih je približno 30 ml/min.
The safety profile of lamotrigine in children aged 1 month to 2 years was similar to that in older children except that clinically significant worsening of seizures (>=50%) was reported more often in children under 2 years of age (26%) as compared to older children (14%).
Varnostni profil lamotrigina pri otrocih, starih od 1 meseca do 2 let, je bil podoben kot pri starejših otrocih, le da je bilo klinično pomembno poslabšanje napadov (>= 50 %) pogostejše pri otrocih, mlajših od 2 let (26 %), kot pri starejših otrocih (14 %).
If you chew the tablet:
Če tableto prežvečite:
If you have epilepsy, talk to your doctor about driving and using machines.
Če imate epilepsijo, se morate z zdravnikom posvetovati o upravljanju vozil in strojev.
Norway GlaxoSmithKline AS Forskningsveien 2a Postbox 180 Vinderen N-0319 Oslo
GlaxoSmithKline AS Forskningsveien 2a Postbox 180 Vinderen N-0319 Oslo Norveška
Samples for assessment of lamotrigine levels after permanently stopping the contraceptive pill should not be collected during the first week after stopping the pill.
Vzorci za določitev koncentracije lamotrigina po trajnem prenehanju uporabe kontracepcijskih tablet ne smejo biti odvzeti prvi teden po prenehanju tablet.
The apparent plasma half-life in healthy subjects is estimated to be approximately 33 hours (range 14 to 103 hours).
Ocenjeni navidezni plazemski razpolovni čas pri zdravih preiskovancih je približno 33 ur (razpon: od 14 do 103 ure).
Therefore patients receiving Lamictal for bipolar disorder should be closely monitored for clinical worsening (including development of new symptoms) and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes.
Zato je treba bolnike, ki dobivajo zdravilo Lamictal za bipolarno motnjo, natančno spremljati glede kliničnega poslabšanja (vključno s pojavom novih simptomov) in samomorilnosti, zlasti na začetku zdravljenja in v času spremembe odmerka.
It inhibits sustained repetitive firing of neurones and inhibits release of glutamate (the neurotransmitter which plays a key role in the generation of epileptic seizures).
Zavira nenehno ponavljajoče se proženje nevronov in sproščanje glutamata (nevrotransmiterja, ki ima ključno vlogo pri nastanku epileptičnih napadov).
Doses in the range 100 - 400 mg/day used in clinical trials
Odmerki v razponu od 100 do 400 mg/dan, uporabljeni v kliničnih preskušanjih
Lamotrigine (the active substance of Lamictal) is a well-known anti-epileptic agent approved for the treatment of epileptic seizures in most EU-member states on a National basis.
Lamotrigin (zdravilna učinkovina zdravila Lamictal) je dobro znana antiepileptična učinkovina, ki je odobrena za zdravljenje epileptičnih napadov v večini držav članic EU na nacionalni ravni.
A CNS Scientific Advisory Group (SAG) was also consulted to advise the CHMP on Bipolar disorder and its treatment.
Izveden je bil tudi posvet z Znanstveno svetovalno skupino za klinično nevroznanost (Scientific Advisory Group on Clinical Neuroscience - SAG CNS), da bi ta CHMP svetovala o bipolarni motnji in njenem zdravljenju.
The indication will specify that the target population is “Children and adolescents aged 2 to 12 years“.
V indikaciji bo navedeno, da so ciljna populacija „Otroci in mladostniki, stari od 2 do 12 let“.
If you forget to take Lamictal Don't take extra tablets or a double dose to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo Lamictal Ne vzemite dodatnih tablet ali dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
If you have any unwanted Lamictal tablets, don't dispose of them in your waste water or your household rubbish.
Če vam ostanejo tablete Lamictal, ki jih ne potrebujete več, jih ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
GlaxoSmithKline α.ε.β.ε 266 Kifissias Ave 152 32 Halandri Athens
GlaxoSmithKline α.ε.β.ε 266 Kifissias Ave 152 32 Halandri Atene
In women being treated for epilepsy, sudden discontinuation of AED therapy should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.
Pri ženskah, ki se zdravijo zaradi epilepsije, se je treba izogniti nenadni prekinitvi antiepileptikov: povzroči namreč lahko izbruh napadov, ki imajo lahko resne posledice za žensko in nerojenega otroka.
Current lamotrigine stabilisation dose (prior to addition)
Trenutni stabilizacijski odmerek lamotrigina (pred dodatkom)
The primary endpoint was "Time to Intervention for a Mood Episode (TIME)", where the interventions were additional pharmacotherapy or electroconvulsive therapy (ECT).
Primarna končna točka je bil čas (Time to Intervention for a Mood Episode) TIME, kjer je bilo intervenirano s farmakoterapijo ali elektrokonvulzivno terapijo (ECT).
Then drink some more water to make sure you have swallowed all the medicine.
Potem popijte še nekaj vode, da boste res zaužili vse zdravilo.
General dosing recommendations for Lamictal in special patient populations
Splošna priporočila za odmerjanje Lamictala v posebnih populacijah bolnikov
These effects are likely to contribute to the anticonvulsant properties of lamotrigine.
Ti učinki verjetno pripomorejo k antikonvulzivnemu delovanju lamotrigina.
In a clinical study, there was no clinically significant effect of lamotrigine on QT interval in healthy adult volunteers (see section 5.1).
V klinični študiji niso ugotovili klinično pomembnega vpliva lamotrigina na interval QT pri zdravih odraslih prostovoljcih (glejte poglavje 5.1).
Acute ingestion of doses in excess of 10 to 20 times the maximum therapeutic dose has been reported.
Poročali so o akutnem zaužitja odmerkov, ki so za 10- do 20-krat presegali največji terapevtski odmerek.
In the subset of bipolar disorder trials, the rate of events was numerically, but not statistically significantly, greater for lamotrigine (29/1212 [2.4%]) compared with placebo (19/1054 [1.8%]).
V podskupini preskušanj pri bipolarni motnji je bil delež teh pojavov številsko, ne pa tudi statistično značilno večji pri lamotriginu (29/1212 [2,4 %]) kot pri placebu (19/1054 [1,8 %]).
In addition, a study of bufuralol metabolism using human liver microsome preparations suggested that lamotrigine would not reduce the clearance of medicinal products metabolised predominantly by CYP2D6.
Poleg tega je študija presnove bufuralola z uporabo pripravkov človeških jetrnih mikrosomov pokazala, da lamotrigin ne bi zmanjšal očistka zdravil, ki se presnavljajo predvsem s CYP2D6.
Monotherapy in Lennox-Gastaut Syndrome is rarely achievable, as usually more than one medicinal product is needed to control the symptoms.
Monoterapija je pri Lennox-Gastautovem sindromu redko izvedljiva, saj je običajno za nadzor simptomov potrebno več kot le eno zdravilo.
One registry has reported an increased incidence of facial clefts.
En register je navajal večjo incidenco obraznih shiz.
You should not stop treatment for your epilepsy while you're pregnant.
Zdravljenja epilepsije med nosečnostjo ne smete prekiniti.
The pharmacokinetics of lamotrigine are linear up to 450 mg, the highest single dose tested.
Farmakokinetika lamotrigina je linearna do odmerka 450 mg, ki je največji testirani posamični odmerek.
‘Proportion' of patients being event free at week 76 Study SCAB2003 Bipolar I
"Delež" bolnikov, ki so bili 76. teden brez dogodka Študija SCAB2003 Bipolarna I
The incidence of suicidal ideation and behaviour was evaluated in a pooled analysis of placebo-controlled clinical trials with lamotrigine involving a total of 6467 patients from a number of indications.
Incidenco samomorilnega razmišljanja in vedenja so ocenili v kumulativni analizi s placebom kontroliranih kliničnih preskušanj lamotrigina, ki so skupaj zajela 6.467 bolnikov z več različnimi indikacijami.
However, both sections should be consulted when considering the overall safety profile of lamotrigine.
Vendar morate za celotno oceno varnosti lamotrigina upoštevati obe poglavji.
Laboratoire GlaxoSmithKline 100 Route de Versailles 78163 Marly-le-Roi Cedex France
Laboratoire GlaxoSmithKline 100 Route de Versailles 78163 Marly-le-Roi Cedex Francija
Animal studies have shown developmental toxicity (see section 5.3).
Študije na živalih so pokazale toksične učinke na razvoj (glejte poglavje 5.3).
It can be used on its own to treat a type of epilepsy called typical absence seizures.
Samega ga je mogoče uporabljati za zdravljenje posebne vrste epilepsije, t. i. tipičnih absenčnih napadov.
Do not take Lamictal:
Ne uporabljajte zdravila Lamictal:
The efficacy and safety of adjunctive therapy in partial seizures in patients aged 1 to 24 months has been evaluated in a small double-blind placebo-controlled withdrawal study.
Učinkovitost in varnost dodatne terapije parcialnih napadov pri bolnikih, starih od 1 do 24 mesecev, so ocenili v majhni dvojno slepi, s placebo kontrolirani odtegnitveni študiji.
There is no consensus on which drug should be used as initial treatment; however, the data analysed do not exclude that lamotrigine could be the initial agent.
Ni enotnega mnenja, katero zdravilo naj se uporabi pri začetnem zdravljenju, vendar pa na podlagi analiziranih podatkov lamotrigina ni mogoče izključiti kot začetno učinkovino.
In patients with more than one seizure type, the observed benefit of control for one seizure type should be weighed against any observed worsening in another seizure type.
Pri bolnikih z več kot eno vrsto napadov morate opaženo korist nadzora ene vrste napadov pretehtati v primerjavi z morebitnim poslabšanjem druge vrste napadov.
The risk of serious skin rashes in children is higher than in adults.
Tveganje za resne izpuščaje na koži je pri otrocih večje kot pri odraslih.
Although the Marketing Authorisation Holder has not conducted specific studies with lamotrigine monotherapy solely in patients with primary generalised tonic clonic seizures, data from controlled initial monotherapy studies (studies UK49/89, UK74) reassure on the efficacy of lamotrigine on this seizure types.
Čeprav imetnik dovoljenja za promet z zdravilom ni izvedel specifičnih študij samo z bolniki s primarno generaliziranimi tonično-kloničnimi napadi, v katerih bi bil lamotrigin uporabljen kot monoterapija, podatki iz kontroliranih začetnih študij uporabe v monoterapiji (študije UK49/89, UK74) dokazujejo učinkovitost lamotrigina pri tovrstnih napadih.
Similar cases have occurred in association with the use of lamotrigine.
Podobni primeri so se pojavili med uporabo lamotrigina.
To stop taking Lamictal, it is important that your dose is reduced gradually, over about 2 weeks.
Pri prenehanju jemanja zdravila Lamictal je pomembno, da odmerek zmanjšujete postopoma približno 2 tedna.
The Marketing Authorisation Holder commits to timely submission of MR/national variations to implement labelling changes, which may be agreed following Pharmacovigilance Working Party (PhVWP) recommendation concerning suicidal ideation and behaviour with anti-epileptic drugs.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo pravočasno predložil vloge za spremembe v zvezi s postopkom medsebojnega priznavanja/nacionalnim postopkom zaradi uvedbe spremenjenega označevanja, ki se lahko odobrijo na podlagi priporočila Delovne skupine za farmakovigilanco (PhVWP) glede samomorilnega razmišljanja in vedenja pri zdravilih proti epilepsiji.
The decrease after 48 weeks of treatment was 10% from 41 to 37 mL/min between the young and elderly groups.
Po 48 tednih zdravljenja je bilo zmanjšanje v mlajši in starejši skupini 10 %, iz 41 na 37 ml/min.
There is a suggestion in the data that responses in combination with enzyme inducers is less than in combination with non-enzyme inducing antiepileptic agents.
Podatki kažejo, da je odziv pri kombinaciji z induktorji encimov manjši kot pri kombinaciji z antiepileptiki, ki ne inducirajo encimov.
Manufacturer: <Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, United Kingdom.>
Izdelovalec: <Glaxo Operations UK Limited (posluje kot Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, Velika Britanija.>
Î Tell your doctor if you are taking, or if you start or stop taking, any of these.
Î Zdravniku morate povedati, če jemljete ali če začnete ali nehati jemati katero od teh zdravil.
All patients (adults and children) who develop a rash should be promptly evaluated and Lamictal withdrawn immediately unless the rash is clearly not related to lamotrigine treatment.
Vse bolnike (odrasle in otroke), ki se jim pojavi izpuščaj, morate takoj pregledati in zdravljenje z Lamictalom nemudoma prekiniti, razen če izpuščaj zagotovo ni povezan z uporabo lamotrigina.
The age range will be modified to reflect the ages for which supporting data are available, adults and patients aged 13 years and older (adolescents).
Starostni razpon bo spremenjen tako, da bo izražal starost, za katero so na voljo podporni podatki, tj. odrasle in bolnike, stare 13 let ali več (mladostnike).
• For children aged between 2 and 12 years, Lamictal can be used with other medicines, to treat those conditions.
• Pri otrocih od 2. do 12. leta starosti se lahko Lamictal uporablja za zdravljenje teh bolezni skupaj z drugimi zdravili.
<GlaxoSmithKline EOOD, Gradinarska Street 5, Sofia 1510, Bulgaria.>
<GlaxoSmithKline EOOD, Gradinarska Street 5, Sofia 1510, Bolgarija.>
If you have bipolar disorder, you may be more likely to think like this:
Pri bipolarni motnji je pojav takšnih misli verjetnejši:
The benefit/risk of lamotrigine as add-on treatment in primary generalised tonic clonic seizures in children is also considered favourable.
Tudi razmerje med koristmi in tveganji za lamotrigin kot dopolnilno zdravljenje pri primarno generaliziranih tonično-kloničnih napadih pri otrocih velja za ugodno.
During other clinical experience: Very common:
Druge klinične izkušnje: Zelo pogosti:
Current lamotrigine stabilisation dose (prior to withdrawal)
Trenutni stabilizacijski odmerek lamotrigina (pred opustitvijo)
Potential interactions between levetiracetam and lamotrigine were assessed by evaluating serum concentrations of both agents during placebo-controlled clinical trials.
Možne interakcije med levetiracetamom in lamotriginom so ocenili z merjenjem koncentracij obeh zdravil v serumu med kliničnimi preskušanji, kontroliranimi s placebom.
The prevention of recurrence of both type of episodes has not been shown for lamotrigine.
Za lamotrigin preprečevanje ponovitev obeh vrst epizod ni bilo dokazano.
It is recommended that from the time that the hormonal contraceptive is started, the lamotrigine dose is increased by 50 to 100 mg/day every week, according to the individual clinical response.
Priporočljivo je, da ob začetku uporabe hormonskega kontraceptiva odmerek lamotrigina zvišate za 50 do 100 mg/dan vsak teden, v skladu s kliničnim odzivom posamezne bolnice.
• uncontrollable body movements (tics), uncontrollable muscle spasms affecting the eyes, head and torso (choreoathetosis), or other unusual body movements such as jerking, shaking or stiffness
• neobvladljivi gibi telesa (tiki), neobvladljivi mišični spazmi, ki prizadenejo oči, glavo in trup (horeoatetoza), ali drugi nenavadni gibi telesa, npr. trzanje, tresenje ali togost
After single doses apparent clearance decreased by 12% from 35 mL/min at age 20 to 31 mL/min at 70 years.
Po posamičnih odmerkih se je navidezni očistek zmanjšal za 12 % iz 35 ml/min pri starosti 20 let na 31 ml/min pri starosti 70 let.
Clinical efficacy and safety in Lennox-Gastaut syndrome
Klinična učinkovitost in varnost pri Lennox-Gastautovem sindromu
* Other oral contraceptive and HRT treatments have not been studied, though they may similarly affect lamotrigine pharmacokinetic parameters (see sections 4.2 and 4.4).
* Drugi peroralni kontraceptivi in HNZ niso raziskani, a verjetno lahko na farmakokinetične parametre lamotrigina vplivajo podobno (glejte poglavji 4.2 in 4.4).
You can take Lamictal dispersible/chewable tablets by swallowing them whole with a little water, by chewing them, or by dissolving them in water:
Lamictal disperzibilne/žvečljive tablete lahko vzamete tako, da jih pogoltnete cele z nekaj vode, jih prežvečite, ali jih raztopite v vodi:
Escalation and maintenance doses should be adjusted according to clinical response (see section 5.2).
Zviševanje odmerkov in vzdrževalne odmerke morate prilagoditi kliničnemu odzivu (glejte poglavje 5.2).
Clearance and half-life are independent of dose.
Očistek in razpolovni čas nista odvisna od odmerka.