natgillin/translations-raw huggingface dataset:
These effects are normally mild to moderate and often disappear after a few weeks.
- Ebatavalised menstruaaltsüklid, sh vererohked ja pikenenud tsüklid
Very common side effects (these can affect more than 1 in 10 patients treated) Feeling sick (nausea), headache, dry mouth, feeling sleepy, fatigue, dizziness and constipation.
- Kõrgenenud vererõhk, külmatunne sõrmedes ja/ või varvastes, pearinglus (eriti järsul
Common side effects (these can affect from 1 to 10 users in 100 patients treated) • Tiredness, trouble sleeping, anxiety, feeling agitated or having abnormal dreams. • Tremor or numbness, including numbness or tingling of the skin. • Diarrhoea, being sick (vomiting), heartburn, breaking wind, stomach pain. • Tinnitus (perception of sound in the ear when there is no external sound). • Blurred eyesight. • Feeling the heart pumping in the chest, flushing, increased sweating, night sweats • Problems getting an erection, less sex drive. • (Itchy) rash. • Muscle pain, muscle tightness, muscle spasm. • Increased yawning. • Lack of appetite, weight loss.
- Sagedasem urineerimine, öine urineerimisvajadus, raskused urineerimisel, urineerimisvõimatus või
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
- Veetustumine
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).
- Maania (häire, mille sümptomiteks on liigne aktiivsus, mõtete sööst ja unevajaduse vähenemine),
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).
mis võib tekitada eufoorilisi tundeid, uimasust, kohmakust, rahutust, purjusoleku tunnet, palavikku, higistamist või lihasjäikust), krambid
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- Naha kollane värvus (kollatõbi), maksapuudulikkus, Stevensi- Johnsoni sündroom, äkiline naha või
HOW TO STORE CYMBALTA
CYMBALTA SÄILITAMINE
Do not use CYMBALTA after the expiry date which is stated on the carton.
45 Mitte kasutada pärast pakendil märgitud kõlblikkusaja lõppu.
6 Store in the original package.
Hoida originaalpakendis.
What CYMBALTA contains CYMBALTA is available in two strengths:
CYMBALTA on müügil kahe tugevusena:
30 and 60 mg.
30 ja 60 mg.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride)
Iga kapsel sisaldab 30 või 60 mg duloksetiini (vesinikkloriidina).
Capsule shell: gelatin, sodium lauryl sulphate, titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg).
Kapsli kate: želatiin, naatriumlaurüülsulfaat, titaandioksiid (E171), indigokarmiin (E132), kollane raudoksiid (E172) (ainult 60 mg) ja farmatseutiline roheline toidutint (30 mg) või farmatseutiline valge toidutint (60 mg).
Edible green ink: black iron oxide-synthetic (E172), yellow iron oxide- synthetic (E172), propylene glycol, shellac.
Farmatseutiline roheline toidutint: sünteetiline must raudoksiid (E172), sünteetiline kollane raudoksiid (E172), propüleenglükool, šellak.
Edible White Ink: titanium dioxide (E171), propylene glycol, shellac, povidone.
Farmatseutiline valge toidutint: titaandioksiid (E171), propüleenglükool, šellak, povidoon.
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.
Iga CYMBALTA kapsel sisaldab duloksetiinvesinikkloriidi kuulikesi, mis on kaetud maohappe eest kaitsva kattega.
CYMBALTA is available in 2 strenghts:
CYMBALTA on saadaval kahe tugevusena:
30 mg and 60 mg.
30 mg ja 60 mg.
The 30 mg capsules are blue and white and are printed with ‘ 30 mg’ and the code ‘ 9543’.
30 mg kapsel on sinine ja valge ning sellele on trükitud “ 30 mg ” ja kood “ 9543 ”.
The 60 mg capsules are blue and green and are printed with ‘ 60 mg’ and the code ‘ 9542’.
60 mg kapsel on sinine ja roheline ning sellele on trükitud “ 60 mg ” ja kood “ 9542 ”.
CYMBALTA 30 mg is available in packs of 7, 28 and 98 capsules.
CYMBALTA 30 mg on müügil 7, 28 ja 98 kapsliga pakenditena.
CYMBALTA 60 mg is available in packs of 28, 56, 84, 98, 100 and 500 capsules.
CYMBALTA 60 mg on müügil 28, 56, 84, 98, 100 ja 500 kapsliga pakenditena.
7 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
46 Lisaküsimuste tekkimisel selle ravimi kohta pöörduge palun müügiloa hoidja kohaliku esindaja poole.
Tél/ Tel: +32 27 73 33 11 България ТП "Ели Лили Недерланд "Б .В. - България тел. + 359 2 491 41 40 Č eská republika Boehringer Ingelheim spol. s r. o.
Tél/ Tel: +32 27 73 33 11 България ТП "Ели Лили Недерланд" Б. В. - България тел. + 359 2 491 41 40
KG Tel: +49 (0) 69 50 50 83 09 Eesti Boehringer Ingelheim Pharma GmbH Tel: + 37 2 60 80 940 Ελλάδα ΦΑΡΜΑΣΕΡΒ -ΛΙΛΛΥ Α .Ε .Β .Ε.
KG Tel: +49 (0) 69 50 50 83 09 Eesti Boehringer Ingelheim Pharma GmbH Tel: + 37 2 60 80 940 Ελλάδα ΦΑΡΜΑΣΕΡΒ- ΛΙΛΛΥ Α. Ε. Β. Ε.
Τηλ: +30 210 629 4600 España Dista S. A..
Τηλ: +30 210 629 4600 España Dista S. A.
Tel: + 34 91 623 17 32 France Boehringer Ingelheim France S. A. S.
Tel: + 34- 91 623 17 32 France Boehringer Ingelheim France S. A. S.
Tel: + 39- 055 42571 Κύπρος Boehringer Ingelheim Ellas A. E.
Tel: + 39 - 055 42571 Κύπρος Boehringer Ingelheim Ellas A. E.
Boehringer Ingelheim Comm. V.
Malta Boehringer Ingelheim Ltd.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
47 Täpne informatsioon selle ravimi kohta on kättesaadav Euroopa Ravimiameti (EMEA) kodulehel http: // www. emea. europa. eu.
8
48
It is used with other treatments, such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a special diet.
Cystadanet kasutatakse koos muu raviga, nt B6 - vitamiini (püridoksiin), B12- vitamiini (kobalamiin), folaadi ja eridieediga.
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).
Cystadanet kasutatakse kõiki kolme teadaolevat liiki homotsüstinuuriaga patsientidel, kus haigus on põhjustatud metioniini lagundamiseks vajalike ainete vaegusest (tsüstationiini beetasüntaasi (CBS) või 5, 10- metüleentetrahüdrofolaadi reduktaasi (MTHFR) vaegus või kobalamiini kofaktori metabolismi (cbl) puudulikkus).
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.
Et homotsüstinuuriaga patsiente on vähe, on see haigus harvaesinev ja Cystadane nimetati 9. juulil 2001 harva kasutatavaks ravimiks.
(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 Kuidas Cystadane toimib?
In homocystinuria, betaine reduces homocysteine levels in the blood by facilitating a reaction in the body called ‘ methylation’, which converts homocysteine back into methionine.
Homotsüstinuuria korral vähendab betaiin vere homotsüsteiinitaset, soodustades organismi metülatsioonireaktsiooni, mille tulemusena homotsüsteiin muundub tagasi metioniiniks.
This included 202 reports that described the effects of Cystadane, given at a variety of doses, on homocysteine levels in homocystinuria patients of various ages.
Ettevõte esitas Cystadane kohta teaduslikus kirjanduses leiduvaid andmeid, sealhulgas 202 teadet, milles kirjeldati mitmesugustes annustes manustatud Cystadane toimet homotsüsteiinitasemele eri vanuses homotsüstinuuriapatsientidel.
Most patients were also taking vitamins B6 or B12, or folate.
Enamik patsientidest kasutas ka B6 - või B12- vitamiini või folaati.
The most common side effect when taking Cystadane (seen in more than 1 patient in 10) is elevated levels of methionine in the blood.
Kõige sagedam kõrvaltoime Cystadane kasutamisel (mida on esinenud rohkem kui 1 patsiendil 10- st) on metioniinitaseme tõus veres.
The committee decided that Cystadane’ s benefits outweighed its risks in the adjunctive treatment of homocystinuria, when it is used according to its indication.
Komitee leidis, et Cystadane kasulikkus kasutamisel vastavalt selle näidustusele homotsüstinuuria täiendava ravina on suurem kui sellega kaasnevad riskid.
The European Commission granted a marketing authorisation valid throughout the European Union for Cystadane to Orphan Europe SARL on 15 February 2007.
Muu teave Cystadane kohta Euroopa Komisjon väljastas Cystadane müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Orphan Europe SARL 15. veebruaril 2007.
The record of Cystadane’ s designation as an orphan medicine is available here.
Märge Cystadane nimetamise kohta harva kasutatavaks ravimiks on esitatud siin.
bottle (HDPE)
pudel (HDPE)
1 bottle+3 measuring spoons (1g,150mg, 100mg)
1 pudel+3 measuring spoons (1g, 150mg, 100mg)
Three measuring spoons dispense 1 g, 150 mg and 100 mg of betaine anhydrous.
Kolme mõõtelusikaga võib mõõta 1 g, 150 mg ja 100 mg veevaba betaiini.
For full list of excipients, see section 6.1.
Abiainete täielik loetelu vt lõik 6. 1.
Oral powder White free flowing powder.
Suukaudne pulber Valge vabalt voolav pulber.
Adjunctive treatment of homocystinuria, involving deficiencies or defects in: • cystathionine beta-synthase (CBS), • 5,10-methylene-tetrahydrofolate reductase (MTHFR), • cobalamin cofactor metabolism (cbl).
Homotsüstinuuria lisaravi: • tsüstationiini beetasüntaasi, • 5, 10- metüleentetrahüdrofolaadi reduktaasi, • kobalamiini kofaktori metabolismi puudulikkuse korral.
Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.
Cystadane' t kasutatakse lisaks muule ravile, nt B6- vitamiin (püridoksiin), B12- vitamiin (kobalamiin), folaat ja eridieet.
Cystadane treatment should be supervised by a physician experienced in the treatment of patients with homocystinuria.
Ravi Cystadane' ga peaks toimuma homotsüstinuuriaga patsientide ravis kogemusi omava arsti järelevalve all.
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.
Täiskasvanute ja üle 10 aasta vanuste pediaatriliste patsientide soovituslik koguannus on 6 g päevas, mis manustatakse jagatud annustena suukaudselt 3 g kaks korda päevas.
However, dose titration may be preferable in paediatric patients.
Pediaatrilistel patsientidel on siiski soovitatav annust titreerida.
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.
Alla 10 aasta vanuste pediaatriliste patsientide tavaline efektiivne raviskeem on 100 mg kehamassi kg kohta päevas, mis manustatakse 2 annusena päevas; sageduse suurendamine rohkem kui kahele korrale päevas ja/ või annuse suurendamine üle 150 mg kehamassi kg kohta päevas homotsüsteiini vähendavat toimet ei paranda.
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.
Kasutamine maksa - või neerukahjustuse korral Kogemused betaiini kasutamisega neerupuudulikkusega või alkoholist mittepõhjustatud maksasteatoosiga patsientidel on näidanud, et Cystadane annustamisskeemi kohandamine ei ole vajalik.
Three measuring spoons are provided which dispense either 100 mg, 150 mg or 1 g of betaine anhydrous.
Lisatud on kolm mõõtelusikat, millega võib mõõta 1 g, 150 mg või 100 mg veevaba betaiini.
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.
2 tasase pinnaga, näiteks noaseljaga, üle mõõtelusika pealispinna.
Therapeutic monitoring:
Ravi jälgimine:
2 The aim of treatment is to keep plasma levels of total homocysteine below 15 µM or as low as possible.
Ravi eesmärk on hoida üldhomotsüsteiini tase vereplasmas alla 15 µM või võimalikult madal.
Hypersensitivity to betaine.
Ülitundlikkus betaiini suhtes.
Uncommon cases of severe cerebral oedema and hypermethioninemia were reported within 2 weeks to 6 months of starting betaine therapy (see section 4.8).
2 nädala kuni 6 kuu jooksul alates ravi alustamisest betaiiniga esines aeg- ajalt rasket ajuturset ja hüpermetionineemiat (vt lõik 4. 8).
Complete recovery was seen after treatment discontinuation:
Pärast ravi katkestamist need seisundid täielikult taandusid:
- Plasma methionine level should be monitored, at start of treatment and periodically thereafter.
Plasma
The plasma methionine concentrations should be kept below 1000 µM.
metioniinikontsentratsioon tuleb hoida allpool 1000 µM.
- If any symptoms of cerebral oedema like morning headaches with vomiting and/ or visual changes
- kui tekivad ajuturse sümptomid, näiteks hommikused peavalud koos oksendamisega ja/ või
appear, plasma methionine level and compliance to the diet should be checked and treatment with Cystadane interrupted.
nägemishäired, tuleb kontrollida plasma metioniinitaset ja dieedi järgimist ning katkestada ravi Cystadane' ga.
- If symptoms of cerebral oedema recur after re-introduction of treatment then betaine therapy
- kui pärast ravi taasalustamist tekib uuesti ajuturse, tuleb ravi betaiiniga määramatuks ajaks
should be discontinued indefinitely.
lõpetada.
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).
Võimalike koostoimete ohu minimeerimiseks on soovitatav jätta betaiini ja aminohappesegude ja/ või vigabatriini ja GABA analooge sisaldavate ravimite võtmise vahele 30 minutit (vt lõik 4. 5).
Based on in vitro data, betaine might interact with amino acids mixtures and medicinal products containing vigabatrin and GABA analogues.
In vitro andmete põhjal võib betaiinil tekkida koostoimeid aminohappesegudega ja vigabatriini ja GABA analooge sisaldavate ravimitega.
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.
Rasedus Piiratud arvu (7) rasedate kohta saadud andmed ei näita betaiini kahjulikku toimet rasedusele ja loote/ vastsündinu tervisele.
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.
Betaiini manustamine raseduse ajal lisaks püridoksiinile, folaadile, antikoagulandile ja dieedile vereplasma homotsüsteiinitaseme hoolika jälgimisega on ema ja loote tervisele kasulik.
However, Cystadane should not be used during pregnancy unless clearly necessary.
Kuid Cystadane' t ei tohi kasutada raseduse ajal, kui see ei ole hädavajalik.
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).
Imetamine Ei ole teada, kas betaiin imendub inimese rinnapiima (kuigi selle metaboolse eelkäija koliini tase inimese rinnapiimas on kõrge).
3 4.8 Undesirable effects
3 4. 8 Kõrvaltoimed
Experience derived from exposure to betaine in about 1,000 patients.
Kogemusi ravist betaiiniga on omandatud ligikaudu 1000 patsiendiga.
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).
Sagedus on määratletud järgmiselt: väga sage (≥ 1/ 10), sage (≥ 1/ 100, < 1/ 10), aeg- ajalt (≥ 1/ 1000, < 1/ 100), harv (≥ 1/ 10 000, < 1/ 1000), väga harv (< 1/ 10 000).
Metabolism and nutrition disorders Psychiatric disorders
Ainevahetus - ja toitumishäired Psühhiaatrilised häired
Uncommon: anorexia Uncommon: agitation, depression, irritability, personality disorder, sleep disturbed
Aeg- ajalt: anoreksia Aeg- ajalt: rahutus, depressioon, ärrituvus, isiksusehäire, unehäired
Nervous system disorders Gastrointestinal disorders
Närvisüsteemi häired Seedetrakti häired
Uncommon: brain oedema* Uncommon: dental disorders, diarrhoea, glossitis, nausea, stomach discomfort, vomiting
Aeg- ajalt: ajuturse * Aeg- ajalt: hammaste häired, kõhulahtisus, keelepõletik, iiveldus, ebamugavustunne kõhus, oksendamine
Skin and subcutaneous tissue disorders Renal and urinary disorder Investigations
Aeg- ajalt: juuste väljalangemine, lööve, naha ebanormaalne lõhn
Uncommon: hair loss, hives, skin odour abnormal Uncommon: urinary incontinence Very common: blood methionine increased*
Aeg- ajalt: kusepidamatus Väga sage: vere metioniinisisalduse suurenemine *
*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.
* 2 nädala kuni 6 kuu jooksul alates ravi alustamisest betaiiniga esines aeg- ajalt rasket ajuturset ja hüpermetionineemiat, mis pärast ravi katkestamist täielikult taandusid.
High increases in plasma methionine levels in a range from 1,000 to 3,000 µM were noted in these patients.
Neil patsientidel olid metioniinitasemed vereplasmas kõrged, 1000 kuni 3000 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.
Kuna ka hüpermetionineemiaga patsientidel on kirjeldatud ajuturset; siis betaiiniraviga seoses tekkivat sekundaarset hüpermetionineemiat on peetud võimalikuks toimemehhanismiks.
For specific recommendations, refer to section 4.4.
Konkreetseid soovitusi vt lõik 4. 4.
Alimentary tract and metabolism product, ATC code:
Farmakoterapeutiline grupp: seedekulgla ja ainevahetuse ravim, ATC- kood:
CBS deficiency; MTHFR deficiency and cbl defect.
Betaiin on alandanud uuringutes homotsüsteiini taset vereplasmas kolme liiki homotsüstinuuria korral, s. t tsüstationiini beetasüntaasi puudulikkuse, 5, 10- metüleentetrahüdrofolaadi reduktaasi puudulikkuse ja kobalamiini kofaktori metabolismi puudulikkuse korral.
Betaine acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria.
Betaiin toimib homotsüstinuuriaga patsientidel homotsüsteiini remetüleerimisel metioniiniks metüülrühma loovutajana.
As a result, plasma levels of homocysteine should decrease in these patients, to 20-30% of pre-treatment levels.
Selle tulemusena peaks neil patsientidel homotsüsteiini tase vereplasmas vähenema 20- 30% - ni ravieelsest tasemest.
Elevated homocysteine plasma levels are associated with cardiovascular events such as thrombosis, osteoporosis, skeletal abnormalities, and optic lens dislocation.
Homotsüsteiini kõrget taset vereplasmas seostatakse selliste südame ja veresoonkonna nähtudega nagu tromboos, osteoporoos, skeleti häired ja silmaläätse nihked.
In observational studies, clinical improvement (cardiovascular and neurodevelopmental) was reported by the treating physician in about 75% of patients taking betaine.
Vaatlusuuringutes täheldas raviarst (südame ja veresoonkonna seisundi ja neuroloogilise arengu) kliinilist paranemist ligikaudu 75% - l patsientidest, kes kasutasid betaiini.
Most of these patients were also receiving other treatments such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin) and folate with variable biochemical responses.
Enamik neist patsientidest kasutas lisaks muid ravimeid, nt B6 - vitamiini (püridoksiin), B12- vitamiini (kobalamiin) ja folaati, ning neil oli erinevaid biokeemilisi ravivastuseid.
In most cases, adding betaine resulted in a further reduction in plasma homocysteine level.
Enamikul juhtudel vähenes betaiini lisamisel homotsüsteiini tase vereplasmas veelgi.
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.
Haiguse püsimist põhjustab ka
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.
4 homotsüstinuuria hiline avastamine seisundis, kus on tekkinud sümptomid, sest sel juhul on tekkinud (oftalmoloogilised, skeleti) sidekoe pöördumatud kahjustused, mida ei saa edasise raviga korrigeerida.
4 Betaine has also been shown to increase plasma methionine and S-adenosyl methionine (SAM) levels in patients with MTHFR deficiency and cbl defects.
Betaiin on uuringutes 5, 10- metüleentetrahüdrofolaadi reduktaasi puudulikkuse ja kobalamiini kofaktori metabolismi puudulikkusega patsientidel tõstnud ka metioniini ja S- adenosüülmetioniini taset vereplasmas.
In a few cases, increased plasma methionine levels were associated with cerebral oedema (see sections 4.4 and 4.8).
Mõnedel juhtudel seostati plasma metioniinitaseme tõusu ajutursega (vt lõigud 4. 4 ja 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.
Homotsüsteiini plasmatasemete jälgimine on näidanud, et betaiini toime algas mitme päeva jooksul ning et stabiilne ravivastus saavutati ühe kuu jooksul.