natgillin/translations-raw huggingface dataset:
5 Uncommon side effects (these can affect from 1 to 10 users in 1,000 patients treated) • Throat inflammation. • Feeling disorientated, feeling sleepy, lack of motivation. • Tasting things differently than usual, disturbance in attention, stiffness, spasms and involuntary movements of the muscles, muscle twitching, abnormal manner of walking. • Poor sleep quality • Burping, indigestion, gastroenteritis • Vertigo, ear pain. • Inflammation of the liver that may cause abdominal pain • Large pupils (the dark centre of the eye), visual disturbance. • Fast or irregular heart beat • Sexual problems, including changes in ejaculation, orgasm. • Abnormal periods, including heavy or prolonged periods. • Allergic reactions, increased tendency to bruise, blisters or sensitivity to sunlight • Increase in blood pressure, feeling cold in your fingers and/ or toes, feeling dizzy (particularly when standing up too quickly), cold sweats, shivering or fainting. • An increased level of sugar in the blood. • Need to pass more urine than normal, need to pass urine during the night, difficulty or inability to pass urine or having an urine flow decreased. • Grinding of teeth, feeling hot/ cold, thirst, throat tightness, nose bleeds. • Weight gain
Občasni neželeni učinki (se lahko pojavijo pri 1 do 10 bolnikov od 1. 000 zdravljenih bolnikov) • Vnetje grla. • Zmedenost, zaspanost, pomanjkanje motivacije. • Spremenjeno okušanje stvari, motnja pozornosti, okornost, krči in nehoteni gibi mišic, mišično trzanje, nenormalen način hoje. • Slaba kvaliteta spanja. • Riganje, slaba prebava, gastroenteritis. • Vrtoglavica, ušesna bolečina. • Vnetje jeter, ki lahko povzroči bolečine v trebuhu. • Večje zenice (temni osrednji del očesa), motnja vida. • Hitro ali nepravilno bitje srca. • Težave s spolnostjo, vključno s spremembami v ejakulaciji, orgazmu. • Neobičajna menstruacija, vključno z močno ali podaljšano menstruacijo. • Alergične reakcije, povečano nagnjenje k modricam, mehurji ali občutljivost na sončno svetlobo. • Zvišan krvni tlak, občutek mraza v prstih in/ ali prstih na nogah, občutek omotičnosti (zlasti ob prehitrem vstajanju), hladen znoj, drgetanje ali omedlevica. • Zvišan nivo sladkorja v krvi. • Bolj pogosto odvajanje urina, nočno odvajanje urina, težave ali nezmožnost odvajanja urina ali slabši curek urina. • Škrtanje z zobmi, dehidracija, občutek vročine/ mraza, žeja, napeto grlo, krvavitve iz nosu. • Zvečanje telesne mase.
Rare side effects (these can affect from 1 to 10 users in 10,000 patients treated) • Decrease of activity of the thyroid gland. • Dehydration. • Mania (a disorder which symptoms are over activity, racing thoughts and decrease need for sleep), experiencing aggression and anger. • Bad breath. • Increased pressure in the eye. • Menopausal symptoms. • Contraction of the jaw muscle. • Increased level of cholesterol in the blood, low levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused), syndrome of inadequate secretion of anti-diuretic hormone (SIADH).
Redki neželeni učinki (se lahko pojavijo pri 1 do 10 bolnikov od 10. 000 zdravljenih bolnikov) • Zmanjšana aktivnost žleze ščitnice. • Dehidracija. • Manija (motnja s simptomi prevelike aktivnosti, bežečih misli in zmanjšane potrebe po spanju), agresivnost in jeza. • Slab zadah. • Zvišan tlak v očesu. • Menopavzalni simptomi. • Krčenje čeljustne mišice. • Zvišan nivo holesterola v krvi, nizka raven natrija v krvi (simptomi so slabost in slabo počutje z občutkom šibkosti mišic in zmedenostjo), sindom nezadostnenega izločanja antidiuretičnega hormona (SIADH - syndrome of inadequate secretion of anti- diuretic hormone).
Other possible side effects • Hallucinations, suicidal thoughts, behaviour. • A sensation of restlessness or an inability to sit or stand still or “ Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits. • Passing bright red blood in your stools, vomiting blood, or black tarry stools (faeces). • Having abnormal urine odour. • Chest pain. • Yellow colouration of the skin (jaundice), hepatic failure, Stevens-Johnson syndrome, sudden swelling of skin or mucosa (angioedema).
Drugi neželeni učinki • Halucinacije, samomorilne misli, vedenje. • Občutek nemira ali nezmožnosti sedenja ali stanja pri miru ali “ serotoninski sindrom ” (redka reakcija, ki lahko povzroči občutke velike sreče, zaspanost, okornost, nemir, občutek pijanosti, vročino, znojenje ali toge mišice), krči. • Svetlo rdeče krvavo blato pri odvajanju, bruhanje krvi ali črno blato. • Nenormalen vonj urina. • Bolečina v prsnem košu. • Rumeno obarvanje kože (zlatenica), odpoved jeter, Stevens- Johnsonov sindrom, nenadna oteklina mukoze kože (angioedem).
HOW TO STORE CYMBALTA
SHRANJEVNJE ZDRAVILA CYMBALTA
Keep out of the reach and sight of children
47 Zdravilo shranjujte nedosegljivo otrokom!
Do not use CYMBALTA after the expiry date which is stated on the carton.
Zdravila CYMBALTA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
6 Store in the original package.
Shranjujte v originalni ovojnini.
What CYMBALTA contains CYMBALTA is available in two strengths:
Kaj vsebuje zdravilo CYMBALTA CYMBALTA je na voljo v dveh jakostih:
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride)
Ena kapsula vsebuje 30 ali 60 mg duloksetina (v obliki klorida).
What CYMBALTA looks like and contents of the pack CYMBALTA is a hard gastro-resistant capsule Each capsule of CYMBALTA contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Vsaka kapsula CYMBALTE vsebuje pelete duloksetinijevega klorida z oblogo za zaščito pred želodčno kislino.
CYMBALTA is available in 2 strenghts:
CYMBALTA je na voljo v dveh jakostih:
30 mg and 60 mg.
30 mg in 60 mg.
The 30 mg capsules are blue and white and are printed with ‘ 30 mg’ and the code ‘ 9543’.
30 mg kapsule so modre in bele z napisom ‘ 30 mg ’ in oznako ‘ 9543 ’.
The 60 mg capsules are blue and green and are printed with ‘ 60 mg’ and the code ‘ 9542’.
60 mg kapsule so modre in zelene z napisom ‘ 60 mg ’ in oznako ‘ 9542 ’.
CYMBALTA 60 mg is available in packs of 28, 56, 84, 98, 100 and 500 capsules.
CYMBALTA 60 mg je na voljo v pakiranjih po 28, 56, 84, 98, 100 in 500 kapsul.
7 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Tel.: + 42 02 34 65 51 11 Danmark Boehringer Ingelheim Danmark A/ S Tlf: +45 39 15 88 88 Deutschland Boehringer Ingelheim Pharma GmbH & Co.
Tel.: + 42 02 34 65 51 11 Danmark Boehringer Ingelheim Danmark A/ S
Tel: + 34 91 623 17 32 France Boehringer Ingelheim France S. A. S.
Tel: + 34- 91 663 50 00 France Boehringer Ingelheim France S. A. S.
Cystadane is used in patients with all three known types of homocystinuria, caused by a lack of the substances required for the breakdown of methionine (‘ cystathionine beta-synthase’ [CBS] or ‘ 5,10- methylene-tetrahydrofolate reductase’ [MTHFR]), or by defects in ‘ cobalamin cofactor metabolism’ (cbl).
Zdravilo Cystadane se uporablja pri bolnikih z vsemi tremi znanimi tipi homocistinurije, ki so posledica pomanjkanja snovi, potrebnih za razgradnjo metionina (cistationin beta- sintaze [CBS] ali 5, 10- metilentetrahidrofolat reduktaze [MTHFR]), ali napake v presnovi kofaktorjev kobalamina (cbl).
Because the number of patients with homocystinuria is low, the disease is considered ‘ rare’, and Cystadane was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 9 July 2001.
Ker je število bolnikov s homocistinurijo majhno, velja ta bolezen za redko, zato je bilo zdravilo Cystadane 9. julija 2001 določeno kot » zdravilo sirota « (zdravilo, ki se uporablja pri redkih boleznih).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How does Cystadane work?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako zdravilo Cystadane deluje?
In homocystinuria, betaine reduces homocysteine levels in the blood by facilitating a reaction in the body called ‘ methylation’, which converts homocysteine back into methionine.
Pri homocistinuriji betain znižuje raven homocisteina v krvi tako, da v telesu spodbuja reakcijo, imenovano metiliranje, pri kateri se homocistein ponovno pretvarja v metionin.
The committee decided that Cystadane’ s benefits outweighed its risks in the adjunctive treatment of homocystinuria, when it is used according to its indication.
Odbor je sklenil, da so koristi zdravila Cystadane, če se uporablja v skladu z indikacijo, večje od z njim povezanih tveganj pri dopolnilnem zdravljenju homocistinurije.
The record of Cystadane’ s designation as an orphan medicine is available here.
Zapis o določitvi zdravila Cystadane kot zdravila sirote najdete tukaj.
bottle (HDPE)
steklenica (HDPE)
1 bottle+3 measuring spoons (1g,150mg, 100mg)
1 steklenica +3 merilne žličke (1g, 150mg, 100mg)
Three measuring spoons dispense 1 g, 150 mg and 100 mg of betaine anhydrous.
Tri merilne žličke, s katerimi odmerimo 1 g, 150 mg in 100 mg brezvodnega betaina.
For full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Oral powder White free flowing powder.
Peroralni prašek Bel sipek peroralni prašek.
Adjunctive treatment of homocystinuria, involving deficiencies or defects in: • cystathionine beta-synthase (CBS), • 5,10-methylene-tetrahydrofolate reductase (MTHFR), • cobalamin cofactor metabolism (cbl).
Dodatno zdravljenje homocistinurije, ki obsega pomanjkanje ali napake: • cistationin beta- sintaze (CBS), • 5, 10- metilentetrahidrofolat reduktaze (MTHFR), • presnove kofaktorjev kobalamina (cbl).
The recommended total daily dose in adult and paediatric patients over 10 years of age is 6 g per day administered orally in divided doses of 3 g two times per day.
Priporočeni celotni dnevni odmerek pri odraslih in pediatričnih bolnikih, starejših od 10 let, je 6 g na dan, razdeljen v dva 3- gramska odmerka na dan.
However, dose titration may be preferable in paediatric patients.
Pri pediatričnih bolnikih pa je bolje odmerek titrirati.
In paediatric patients less than 10 years of age, the usual effective dose regimen is 100 mg/ kg/ day given in 2 doses daily; increasing the frequency above twice daily and/ or the dose above 150 mg/ kg/ day does not improve the homocysteine-lowering effect.
Pri pediatričnih bolnikih, mlajših od 10 let, je običajna učinkovita shema odmerjanja 100 mg/ kg/ dan, dana v 2 dnevnih odmerkih; če dajemo zdravilo pogosteje kot dvakrat na dan ali če zvečamo odmerek nad 150 mg/ kg/ dan ali oboje, se učinek na znižanje homocisteina ne bo izboljšal.
Use in hepatic or renal impairment Experience with betaine therapy in patients with renal insufficiency or non-alcoholic hepatic steatosis has demonstrated no need to adapt the dose regimen of Cystadane.
Uporaba pri okvarah jeter ali ledvic Izkušnje z zdravljenjem z betainom pri bolnikih z insuficienco ledvic ali nealkoholno steatozo jeter so pokazale, da pri teh bolnikih sheme odmerjanja zdravila Cystadane ni treba prilagajati.
It is recommended that a heaped measuring spoon is removed from the container and a flat surface e. g. base of a knife is drawn across the top of the measure.
Priporočamo, da iz vsebnika vzamete zvrhano merilno žličko praška, nato pa čeznjo potegnite z ravno površino, na primer z noževim rezilom.
Therapeutic monitoring:
2 Terapevtsko spremljanje:
2 The aim of treatment is to keep plasma levels of total homocysteine below 15 µM or as low as possible.
Cilj zdravljenja je obdržati koncentracijo celotnega homocisteina v plazmi pod 15 µM ali tako nizko, kolikor je mogoče.
Hypersensitivity to betaine.
Preobčutljivost za betain.
Uncommon cases of severe cerebral oedema and hypermethioninemia were reported within 2 weeks to 6 months of starting betaine therapy (see section 4.8).
Poročali so o občasnih primerih težkega možganskega edema in hipermetioninemije v 2 tednih do 6 mesecih po začetku zdravljenja z betainom (glejte poglavje 4. 8).
- Plasma methionine level should be monitored, at start of treatment and periodically thereafter.
- Spremljati je treba koncentracijo metionina v plazmi, in sicer v začetku zdravljenja in nato v
The plasma methionine concentrations should be kept below 1000 µM.
Koncentracija metionina v plazmi mora biti nižja od 1000 µM.
- If any symptoms of cerebral oedema like morning headaches with vomiting and/ or visual changes
- Če se pojavijo simptomi možganskega edema, na primer jutranji glavoboli z bruhanjem ali
appear, plasma methionine level and compliance to the diet should be checked and treatment with Cystadane interrupted.
spremembami vida ali oboje, je treba preveriti koncentracijo metionina v plazmi, ugotoviti, ali se bolnik drži diete, in prekiniti zdravljenje z zdravilom Cystadane.
- If symptoms of cerebral oedema recur after re-introduction of treatment then betaine therapy
- Če se po ponovni uvedbi zdravljenja simptomi možganskega edema spet pojavijo, je treba
should be discontinued indefinitely.
zdravljenje z betainom za vedno opustiti.
To minimize the risk of potential drug interactions, it is advisable to leave 30 minutes between the intake of betaine and amino acids mixtures and/ or medicinal products containing vigabatrin and GABA analogues (see section 4.5).
Da se nevarnost možnih interakcij med zdravili čim bolj zmanjša, priporočamo, naj med zaužitjem betaina in mešanic aminokislin ali zdravil, ki vsebujejo vigabatrin in analoge GABA ali obojega, mine 30 minut (glejte poglavje 4. 5).
Based on in vitro data, betaine might interact with amino acids mixtures and medicinal products containing vigabatrin and GABA analogues.
Na podlagi podatkov, pridobljenih in vitro, bi se lahko pojavile interakcije z mešanicami aminokislin in zdravil, ki vsebujejo vigabatrin in analoge GABA.
Pregnancy Data on a limited number (7) of exposed pregnancies indicate no adverse event of betaine on pregnancy or on the health of the foetus/ newborn child.
Nosečnost Podatki, zbrani pri omejenem številu (7) nosečnic, ki so bile izpostavljene zdravilu, ne kažejo na možnost škodljivih vplivov betaina na nosečnost ali zdravje zarodka/ novorojenca.
During pregnancy, administering betaine in addition to pyridoxine, folate, anticoagulant and diet under close monitoring of plasma homosysteine would be compatible with good maternal and foetal outcomes.
V nosečnosti bi bila uporaba betaina kot dodatek piridoksinu, folatu, antikoagulantu in dieti ob pazljivem spremljanju homocisteina v plazmi združljiva z ugodnim izidom za mater in plod.
Breast-feeding It is not known whether betaine is excreted in human milk (although its metabolic precursor, choline, occurs at high levels in human milk).
Dojenje Ni znano, ali se betain izloča v materino mleko (čeprav se njegov presnovni prekurzor, holin, v materinem mleku pojavlja v visokih koncentracijah).
3 4.8 Undesirable effects
3 V nadaljevanju so neželeni učinki, o katerih so poročali, navedeni po organskih sistemih in po pogostnosti.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000).
Pogostnosti so definirane kot: zelo pogoste (≥ 1/ 10), pogoste (≥ 1/ 100, < 1/ 10), občasne (≥ 1/ 1. 000, < 1/ 100), redke (≥ 1/ 10. 000, < 1/ 1. 000), zelo redke (< 1/ 10. 000).
Metabolism and nutrition disorders Psychiatric disorders
Presnovne in prehranske motnje Psihiatrične motnje
Uncommon: anorexia Uncommon: agitation, depression, irritability, personality disorder, sleep disturbed
Občasna: anoreksija Občasne: agitiranost, depresija, razdražljivost, osebnostne motnje, motnje spanja
Nervous system disorders Gastrointestinal disorders
Bolezni živčevja Bolezni prebavil
Uncommon: brain oedema* Uncommon: dental disorders, diarrhoea, glossitis, nausea, stomach discomfort, vomiting
Občasna: možganski edem * Občasne: zobne bolezni, driska, glositis, navzea, želodčne težave, bruhanje
Skin and subcutaneous tissue disorders Renal and urinary disorder Investigations
Občasne: izpadanje las, koprivnica, nenormalen vonj kože
Uncommon: hair loss, hives, skin odour abnormal Uncommon: urinary incontinence Very common: blood methionine increased*
Občasna: inkontinenca urina Zelo pogosta: zvišan metionin v krvi *
*Uncommon cases of severe cerebral oedema and hypermethioninemia were reported within 2 weeks to 6 months of starting betaine therapy, with complete recovery after treatment discontinuation.
* Poročali so o občasnih primerih težkega možganskega edema in hipermetioninemije 2 meseca do 6 mesecev po začetku zdravljenja z betainom, po prekinitvi zdravljenja so bolniki povsem okrevali.
High increases in plasma methionine levels in a range from 1,000 to 3,000 µM were noted in these patients.
Pri teh bolnikih so opazili močno zvišanje koncentracije metionina v plazmi, ki je bila med 1. 000 in 3. 000 µM.
As cerebral oedema has also been reported in patients with hypermethioninemia, secondary hypermethioninemia due to betaine therapy has been postulated as a possible mechanism of action.
Ker so pri bolnikih s hipermetioninemijo poročali tudi o možganskem edemu, so domnevali, da je možni mehanizem delovanja sekundarna hipermetioninemija zaradi zdravljenja z betainom.
For specific recommendations, refer to section 4.4.
Za natančna priporočila glejte poglavje 4. 4.
Alimentary tract and metabolism product, ATC code:
Druga zdravila za zdravljenje bolezni prebavil in presnove, oznaka ATC:
CBS deficiency; MTHFR deficiency and cbl defect.
Pokazali so, da betain znižuje koncentracijo homocisteina v plazmi pri treh vrstah homocistinurije, in sicer pri pomanjkanju CBS, pomanjkanju MTHFR in napaki cbl.
Betaine acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria.
Betain deluje kot donator metilnih skupin pri ponovnem metiliranju homocisteina v metionin pri bolnikih s homocistinurijo.
As a result, plasma levels of homocysteine should decrease in these patients, to 20-30% of pre-treatment levels.
Posledično naj bi se plazemska koncentracija homocisteina pri teh bolnikih znižala na 20- 30% ravni pred zdravljenjem.
Elevated homocysteine plasma levels are associated with cardiovascular events such as thrombosis, osteoporosis, skeletal abnormalities, and optic lens dislocation.
Zvišana koncentracija homocisteina v plazmi je povezana s kardiovaskularnimi dogodki, na primer trombozo, z osteoporozo, nenormalnostmi okostja in izpahom očesne leče.
In observational studies, clinical improvement (cardiovascular and neurodevelopmental) was reported by the treating physician in about 75% of patients taking betaine.
Pri opazovalnih študijah je lečeči zdravnik poročal o kliničnem izboljšanju (tako kardiovaskularnem kot glede razvoja živčevja) pri okrog 75% bolnikov, ki so jemali betain.
In most cases, adding betaine resulted in a further reduction in plasma homocysteine level.
Pri večini primerov je imel dodatek betaina za posledico nadaljnje znižanje ravni homocisteina v plazmi.
It is likely that due to the multiple nature of therapy (dietary, pharmaceutical, supportive) in these patients, there may be an element of overestimation in the clinical effects of betaine treatment.
Pri teh bolnikih zaradi večtirnosti zdravljenja (zdravljenje z dieto, z zdravili, podporno zdravljenje) verjetno obstaja element precenjevanja kliničnih učinkov zdravljenja z betainom.
Late detection of homocystinuria in symptomatic state is responsible for residual morbidity due to irreversible damage to connective tissue (ophtalmological, skeletal) that can not be corrected by further therapy.
Pozno odkritje homocistinurije, ko je bolezen že v simptomatskem stadiju, je odgovorno za rezidualno obolevnost zaradi ireverzibilnih okvar vezivnega tkiva (oftalmoloških, skeletnih), ki jih nadaljnje
4 Betaine has also been shown to increase plasma methionine and S-adenosyl methionine (SAM) levels in patients with MTHFR deficiency and cbl defects.
Ni dokazov, da bi se razvijala toleranca.
In CBS-deficient patients without dietary restriction of methionine, excessive accumulation of methionine has been observed.
Pokazali so tudi, da betain zvišuje koncentracijo metionina in S- adenozilmetionina (SAM) v plazmi pri bolnikih s pomanjkanjem MTHFR in napakami cbl.
In a few cases, increased plasma methionine levels were associated with cerebral oedema (see sections 4.4 and 4.8).
V nekaterih primerih so bile zvišane koncentracije metionina v plazmi povezane z možganskim edemom (glejte poglavji 4. 4 in 4. 8).
Monitoring plasma homocysteine levels has demonstrated that the onset of action of betaine occurred within several days and that a steady-state response was achieved within one month.
S spremljanjem koncentracije homocisteina v plazmi so pokazali, da betain začne delovati čez nekaj dni in da se odziv v stanju dinamičnega ravnovesja doseže v enem mesecu.
In paediatric patients less than 3 years of age, the usual effective dose regimen is 100 mg/ kg/ day given in 2 doses daily; increasing the frequency above twice daily and/ or the dose above 150 mg/ kg/ day does not improve the homocysteine-lowering effect.
Pri pediatričnih bolnikih, mlajših od 3 let, je običajna učinkovita shema odmerjanja 100 mg/ kg/ dan, danih v 2 odmerkih na dan; če zdravilo dajemo pogosteje kot dvakrat na dan in/ ali zvečamo odmerek nad 150 mg/ kg/ dan, se učinkovitost zdravila glede zniževanja homocisteina ne izboljša.
Betaine supplementation was shown to improve the metabolic abnormalities in the cerebrospinal fluid of patients with homocystinuria.
Izkazalo se je, da dodajanje betaina izboljša presnovne nenormalnosti v cerebrospinalni tekočini bolnikov s homocistinurijo.
Monitoring betaine plasma concentrations does not help to define the efficacy of treatment, since these concentrations do not directly correspond to the flux through the cytosolic betaine homocysteine methyl transferase pathway.
Spremljanje koncentracije betaina v plazmi ne pomaga pri opredeljevanju učinkovitosti zdravljenja, ker se te koncentracije ne ujemajo neposredno s tokom skozi citosolno betainsko- homocisteinsko metiltransferazno presnovno pot.
The absolute bioavailability of betaine has not been determined.
Absolutne biološke uporabnosti betaina niso ugotovili.
In healthy adult volunteers (age between 21 to 49 years), after a single oral dose of betaine (50 mg/ kg), absorption was rapid (tmax = 0.9 ± 0.3 hours and a Cmax = 0.9 ± 0.2 mM).
Pri zdravih odraslih prostovoljcih (starih med 21 in 49 leti) je bila po enkratnem peroralnem odmerku betaina (50 mg/ kg) absorpcija hitra (tmax = 0, 9 ± 0, 3 ure in Cmax = 0, 9 ± 0, 2 mM).
Betaine was rapidly distributed into a relatively large volume (V/ F = 1.3 l/ kg), with a slow elimination rate (mean half life = 14 h, mean total body clearance, CL/ F, = 84 ml/ h/ kg), renal clearance being negligible (5% of total body clearance), assuming 100% bioavailability.
Betain se je hitro porazdelil po razmeroma velikem prostoru (V/ F = 1, 3 l/ kg) z majhno hitrostjo izločanja (povprečni razpolovni čas = 14 ur, povprečni celotni telesni očistek, CL/ F = 84 ml/ h/ kg), pri čemer je bil ledvični očistek zanemarljiv (5% celotnega telesnega očistka), če predpostavimo 100- odstotno biološko uporabnost.
After a repeated dose regimen of 100 mg/ kg/ day for 5 days, the absorption kinetics did not change but the distribution half life was prolonged significantly (up to 36 h), indicating saturable transport and redistribution processes.
Po shemi ponavljajočih se odmerkov po 100 mg/ kg/ dan 5 dni se kinetika absorpcije ni spremenila, se je pa razpolovni čas porazdelitve signifikantno podaljšal (do 36 ur), kar kaže na to, da se procesi transporta in ponovne porazdelitve nasitijo.