natgillin/translations-raw huggingface dataset:
Cellulose, microcrystalline (E460) Lactose monohydrate Hypromellose (E464) Sodium starch glycolate Magnesium stearate (E470b) Disodium phosphate, anhydrous (E339) Ascorbyl palmitate (E304) Disodium edetate Monobasic sodium phosphate (E339)
Celuloza, mikrokristalna (E460) Laktoza monohidrat
11 Film coat:
11 Hipromeloza (E464) Natrijev karboksimetilškrob Magnezijev stearat (E470b) Natrijev hidrogenfosfat, brezvodni (E339) Askorbilpalmitat (E304) Dinatrijev edetat Natrijev dihidrogenfosfat (E339)
PVC/ ACLAR/ paper-backed aluminium blisters containing 14 tablets.
Pretisni omoti iz aluminija in s podlago iz PVC/ ACLAR/ papirja, ki vsebujejo po 14 tablet.
Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ United Kingdom
Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ Velika Britanija
EU/ 1/ 06/ 353/ 001 EU/ 1/ 06/ 353/ 002 EU/ 1/ 06/ 353/ 003 EU/ 1/ 06/ 353/ 004 EU/ 1/ 06/ 353/ 005
EU/ 1/ 06/ 353/ 001 EU/ 1/ 06/ 353/ 002 EU/ 1/ 06/ 353/ 003 EU/ 1/ 06/ 353/ 004
Encysive (UK) Limited Regus House Highbridge Industrial Estate Oxford Road Uxbridge UB8 1HR United Kingdom
Encysive (UK) Limited Regus House Highbridge Industrial Estate Oxford Road Uxbridge UB8 1HR Velika Britanija
Patheon UK Limited Kingfisher Drive Covingham Swindon, Wilts SN3 5BZ United Kingdom
Patheon UK Limited Kingfisher Drive Covingham Swindon, Wilts SN3 5BZ Velika Britanija
Polar Speed Distribution Ltd Unit 8 Chartmoor Road Leighton Buzzard Bedfordshire LU7 4WG United Kingdom
Polar Speed Distribution Ltd Unit 8 Chartmoor Road Leighton Buzzard Bedfordshire LU7 4WG Velika Britanija
Pfizer Service Company Hog Wei 10-B-1930 Zaventem Belgium
Pfizer Service Company Hog Wei 10- B- 1930 Zaventem Belgija
The MAH must agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all doctors who intend to prescribe Thelin are provided with a physician information pack containing the following: • Product information • Physician information about Thelin
Imetnik dovoljenja za promet se mora o podrobnostih sistema nadzorovane distribucije dogovoriti s pristojnimi nacionalnimi organi in mora program izvajati na nacionalni ravni, da zagotovi, da pred predpisovanjem zdravila, vsi zdravniki, ki nameravajo predpisovati Thelin, dobijo opisno dokumentacijo, ki vsebuje naslednje podatke:
The physician information about Thelin should contain the following key elements: • That Thelin is teratogenic o Use of effective contraception in women of child bearing age o Possible interaction with oral contraceptives and increased risk of thromboembolism o Need to advise female patients about teratogenicity, contraception, if necessary the need for pregnancy testing and what to do if they become pregnant o Referral of patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice
• da je zdraviloThelin teratogeno o Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo. o Obstaja možnost medsebojnega delovanja s peroralnimi kontraceptivi in povečana nevarnost tromboembolizma. o Bolnice morajo biti poučene o teratogenosti ter se z zdravnikom posvetovati o kontracepciji, testu za ugotavljanje nosečnosti in kaj storiti, če zanosijo. o Bolnice, ki zanosijo, je potrebno napotiti k specialistu za teratogenost ali zdravniku, ki ima izkušnje na področju teratogenosti, ter prositi zdravnika za diagnozo, drugo mnenje in nasvet.
• That Thelin is hepatotoxic o Need for liver function tests prior to and during treatment o Contraindication in patients with pre-existing hepatic impairment (Child-Pugh Class A-C). o Need for close monitoring if liver enzymes measure > 3 × upper limit normal (ULN): > 3 and ≤ 5 x ULN:
• da je Thelin hepatotoksičen o Potrebno je preverjati delovanje jeter pred in med zdravljenjem. o Kontraindikacija pri bolnikih z že obstoječo okvaro jeter (stopnja A- C po Child - Pughu). o Če so jetrni encimi ≥ 3 × zgornje meje normalne vrednosti (ZMN), je potrebno bolnika natančno spremljati. > 3 in ≤ 5 × ZMN:
If the aminotransferase levels return to pre-treatment values, return to monthly liver testing. > 5 and ≤ 8 x ULN:
Če se vrednosti aminotransferaz vrnejo na vrednosti pred zdravljenjem, se vrnite na mesečne preiskave jeter. > 5 in ≤ 8 × ZMN:
• Effect of Thelin on bleeding o Interaction with warfarin and vitamin K antagonists leading to an increased INR o Need to decrease established dose of vitamin K antagonist upon starting sitaxentan therapy o Start vitamin K antagonists treatment at a reduced dose if already on sitaxentan sodium o Need for regular monitoring of INR o Be aware of the potential for haemorrhage and investigate as appropriate o Increased risk of epistaxis and gingival bleeding
• da zdravilo Thelin vpliva na krvavitve o Medsebojno delovanje z varfarinom in antagonisti vitamina K, ki lahko pripeljejo do povišane vrednosti INR. o Pred začetkom zdravljenja s sitaksentanat je potrebno zmanjšati uveljavljeni odmerek antagonistov vitamina K. o Če se bolnik že zdravi s natrijev sitaksentanat, je potrebno začeti zdravljenje z antagonisti vitamina K z zmanjšanim odmerkom. o Vrednosti INR je potrebno skrbno spremljati. o Zavedajte se tveganj krvavitev in bolnika primerno preglejte. o Povečano je tveganje krvavitev iz nosu in dlesni.
The information collected should include: o Anonymised patient details – age, sex and aetiology of PAH o Concomitant medications o Reason for discontinuation o ADRs o All serious ADRs o Increase in hepatic enzymes to > 3 × ULN o Anaemia o Haemorrhage 16
16 Zbrani podatki morajo vsebovati: o anonimizirane podatke o bolniku – starost, spol in etiologijo PAH, o hkratna zdravljenja, o razloge za ukinitev, o neželene učinke ○ vsi resni neželeni učinki, ○ povišani jetrni encimi na > 3 x ZMN, ○ anemija, ○ krvavitev, ○ nosečnost in izid, ○ pljučni edem (povezan z vensko- okluzivno boleznijo), ○ možna medsebojna delovanja, ○ neželeni učinki, ki niso navedeni v povzetku glavnih značilnosti zdravila (nepričakovani neželeni učinki).
The Patient information card should include the following information • That Thelin is teratogenic • The need to ensure that women of child bearing age are using effective contraception and that patients should inform their doctors of any possibility of pregnancy before a new prescription is issued • The need for female patients to contact their treating doctor immediately if they suspect that they might be pregnant. • That Thelin is hepatotoxic and they will need to attend for regular blood tests • The need to tell their doctor about any adverse events • The need to tell their doctor that they are taking Thelin
Podatki o zdravilu za bolnika morajo vsebovati naslednje informacije: • da je Thelin teratogen; • da morajo ženske v rodni dobi uporabljati učinkovito kontracepcijsko sredstvo in da morajo bolnice svoje zdravnike obvestiti o možnosti zanositve preden jim zdravnik izda nov recept; • da morajo bolnice svojega zdravnika nemudoma obvestiti o morebitni nosečnosti; • da je Thelin hepatotoksičen in da morajo bolniki redno prihajati na krvne preiskave; • da morajo bolniki obvestiti svojega zdravnika o neželenih učinkih; • da morajo bolniki svojim zdravnikom povedati, da jemljejo zdravilo Thelin.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici 5 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
EU/ 1/ 06/ 353/ 001 (14 film-coated tablets in blisters) EU/ 1/ 06/ 353/ 002 (28 film-coated tablets in blisters) EU/ 1/ 06/ 353/ 003 (56 film-coated tablets in blisters) EU/ 1/ 06/ 353/ 004 (84 film-coated tablets in blisters)
EU/ 1/ 06/ 353/ 001 (14 filmsko obloženih tablet v pretisnih omotih) EU/ 1/ 06/ 353/ 002 (28 filmsko obloženih tablet v pretisnih omotih) EU/ 1/ 06/ 353/ 003 (56 filmsko obloženih tablet v pretisnih omotih) EU/ 1/ 06/ 353/ 004 (84 filmsko obloženih tablet v pretisnih omotih)
21 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
21 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
PVC/ ACLAR/ paper-backed aluminium blisters
Pretisni omoti iz aluminija in s podlago iz PVC/ ACLAR/ papirja
Bottle Label (fix-a form)
Nalepka na plastenki (fix- a form)
It may harm them, even if their symptoms are the same as yours. • If any side effect becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim. • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Thelin is and what it is used for 2.
Kaj je zdravilo Thelin in za kaj ga uporabljamo 2.
Before you take Thelin 3.
Kaj morate vedeti, preden boste vzeli zdravilo Thelin 3.
How to take Thelin 4.
Kako jemati zdravilo Thelin 4.
How to store Thelin 6.
Shranjevanje zdravila Thelin 6.
Do not take Thelin: • If you are allergic (hypersensitive) to sitaxentan sodium or any of the other ingredients in these tablets; • If you have or have had a serious liver problem; • If you have raised levels of some liver enzymes (detected by blood tests); • If you are taking Ciclosporin A (used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of liver or kidney transplants); • If you are breast-feeding (please read the section ‘ Pregnancy and breast-feeding’ below); • If you are a child or adolescent under 18 years old.
Ne jemljite zdravila Thelin: • Če ste alergični na (preobčutljivi za) natrijev sitaksentanat ali katerokoli sestavino zdravila v teh tabletah. • Če imate ali ste imeli resne težave z jetri. • Če imate zvišane ravni določenih jetrnih encimov (ki se določajo s preiskavo krvi). • Če jemljete ciklosporin A (uporablja se za zdravljenje luskavice in revmatoidnega artritisa ter za preprečevanje zavrnitve presajenih jeter ali ledvic). • Če dojite (preberite poglavje „ Nosečnost in dojenje “ v nadaljevanju). • Če ste otrok ali mladostnik, mlajši od 18 let.
Take special care with Thelin: • If you could get pregnant or are pregnant (please read the section “ Pregnancy and breast-feeding” below); • If you develop liver problems or symptoms that might relate to the liver (see ‘ Testing for liver problems’, below); • If you are taking or begin to take anticoagulants (e. g. warfarin, acenocoumarol, fenprocoumon or fluindione) to prevent blood clots.
Bodite posebno pozorni pri jemanju zdravila Thelin: • Če lahko zanosite ali če ste noseči (preberite poglavje „ Nosečnost in dojenje “ v nadaljevanju). • Če se pri vas pojavijo težave z jetri ali simptomi, ki so povezani z jetri (glejte poglavje „ Preiskave za težave z jetri “ v nadaljevanju). • Če jemljete ali ste začeli jemati zdravila proti strjevanju krvi (npr. varfarin, acenokumarol, fenprokumon ali fluindion) za preprečevanje nastajanja krvnih strdkov.
The dose of these medicines may need to be adjusted by your doctor. • If you are taking a statin (e. g. pravastatin or simvastatin). • If you are taking a high dose of nifedipine.
Vaš zdravnik bo morda moral prilagoditi odmerek teh zdravil. • Če jemljete statin (npr. prevastatin ali simvastatin). • Če jemljete visoke odmerke nifedipina.
26 If any of these apply to you, tell your doctor before you start taking Thelin.
26 Obvestite svojega zdravnika, če katerikoli primer velja za vas, preden začnete jemati zdravilo Thelin.
Testing for liver problems Thelin may affect your liver.
Preiskave za težave z jetri Zdravilo Thelin lahko vpliva na jetra.
If you notice any of these signs: • feeling sick (nausea) • being sick (vomiting) • loss of appetite • fever • unusual tiredness • pain in the stomach (abdominal pain) • yellow colouring of the skin and eyes (jaundice) Talk to your doctor immediately.
Če opazite kateregakoli od naslednjih znakov: • slabost (navzeja), • bruhanje, • izguba apetita, • zvišana telesna temperatura, • nenavadna utrujenost, • bolečine v trebuhu (abdominalne bolečine), • rumeno obarvanje kože in oči (zlatenica), nemudoma obvestite svojega zdravnika.
Testing for anaemia This blood test will be done before treatment, then one month and three months after you start taking Thelin tablets.
Preiskave za slabokrvnost Te preiskave boste opravili pred zdravljenjem, nato pa en mesec in tri mesece po začetku jemanja tablet zdravila Thelin.
This includes medicines you bought without a prescription, herbal remedies and vitamins.
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta in vključno z zeliščnimi pripravki ter vitamini.
Thelin should be used with caution if you are taking or begin to take Vitamin K antagonists (e. g. warfarin, acenocoumarol, fenprocoumon or fluindione).
Zdravilo Thelin morate jemati previdno, če jemljete ali ste začeli jemati antagoniste vitamina K (npr. varfarin, acenokumarol, fenprokumon ali fluindion).
Pregnancy and breast-feeding If you are able to get pregnant, you must use effective contraception while taking Thelin.
Nosečnost in dojenje Če lahko zanosite, morate med jemanjem zdravila Thelin uporabljati učinkovito kontracepcijo.
He or she may want you to stop taking Thelin.
Morda bo želel/ a, da prekinete zdravljenje z zdravilom Thelin.
Check with your doctor or pharmacist if you are not sure. • Try to take the tablet at the same time each day to help you remember.
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom. • Tableto vzemite vedno ob isti uri, da si boste lažje zapomnili.
If you take more Thelin than you should If you realise you have taken more Thelin tablets than your doctor has recommended (or if someone else has taken some of your Thelin tablets), contact your doctor straight away.
Če ste vzeli večji odmerek zdravila Thelin, kot bi smeli Če ugotovite, da ste vzeli več tablet zdravila Thelin, kot vam je naročil zdravnik (ali če je vaše tablete zdravila Thelin vzel kdo drug), nemudoma obvestite svojega zdravnika.
If you forget to take Thelin If you miss a dose, take the missed dose as soon as you remember but do not take two tablets in one day.
Vendar ne vzemite dveh tablet v istem dnevu.
Common side effects (likely to affect more than 1 in every 100 people): • swelling in the arms and legs • being unable to sleep • blocked nose and nosebleeds • bleeding from the gums • feeling and/ or being sick, difficulty in passing stools, stomach ache, indigestion and diarrhoea • flushed • cramp in muscles • dizziness • feeling tired • your blood may take longer to clot. • yellowing of the skin or eyes (jaundice) and persistent nausea and/ or vomiting may indicate changes in liver function
Pogosti neželeni učinki (se verjetno pojavijo pri več kot 1 od 100 bolnikov) so: • otekanje rok in nog, • nespečnost, • zamašen nos in krvavitve iz nosu, • krvavitve iz dlesni • občutek slabosti ali slabost, težavno iztrebljanje, bolečine v trebuhu, prebavne motnje in driska, • rdečica, • krči v mišicah, • omotica, • utrujenost, • počasnejše strjevanje krvi. • porumenelost kože ali oči (zlatenica) ter dolgotrajna slabost v želodcu in/ ali bruhanje so lahko znaki spremenjenega delovanja jeter • Redki neželeni učinki (se verjetno pojavijo pri manj kot 1 od 1000 bolnikov) so: • okvara jeter • izpuščaj • anemija (majhno število rdečih krvnih celic) Za več podatkov o težavah z jetri glejte „ Preiskave za težave z jetri “ v poglavju 2.
What Thelin contains • The active substance is sitaxentan sodium.
Kaj vsebuje zdravilo Thelin • Zdravilna učinkovina je natrijev sitaksentanat.
The other ingredients are: • The tablet core contains cellulose, microcrystalline (E460), lactose monohydrate, hypromellose (E464), sodium starch glycolate, magnesium stearate (E470b), anhydrous disodium phosphate (E339), ascorbyl palmitate (E304), disodium edetate and monobasic sodium phosphate (E339). • The film-coat contains stearic acid (E570b), hypromellose (E464), microcrystalline cellulose (E460), titanium dioxide (E171), yellow iron oxide dehydrate (E172), red iron oxide dehydrate (E172) and talc (E553b).
Pomožne snovi so: • Jedro tablete vsebuje mikrokristalno celulozo (E460), laktozo monohidrat, hipromelozo (E464), natrijev škrobni glikolat, magnezijev stearat (E470b), brezvodni natrijev hidrogenfosfat (E339), askorbilpalmitat (E304), dinatrijev edetat in natrijev dihidrogenfosfat (E339). • Filmska obloga vsebuje stearinsko kislino (E570b), hipromelozo (E464), mikrokristalno celulozo (E460), titanov dioksid (E171), rumeni železov oksid dihidrat (E172), rdeči železov oksid dihidrat (E172) in smukec (E553b).
What Thelin tablets look like and contents of the pack Thelin 100 mg film-coated tablets are yellow-to-orange, capsule-shaped tablets, marked with T-100 on one side.
Izgled zdravila Thelin in vsebina pakiranja Thelin 100 mg filmsko obložene tablete so rumene do oranžne barve v obliki kapsule z napisom T- 100 na eni strani.
Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ United Kingdom Tel: +44 (0)208 610 6942
Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ Velika Britanija Tel: +44 (0) 208 610 6942
29 This leaflet was last approved in
29
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH UVELJAVLJAJO DRŽAVE ČLANICE
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH UVELJAVLJAJO DRŽAVE ČLANICE
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all healthcare professionals who are experienced to prescribe/ use Thymanax are provided with educational materials containing the following:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob prihodu zdravila na trg vse osebe, pooblaščene za predpisovanje ali uporabo zdravila Thymanax, dobile izobraževalno gradivo z naslednjo vsebino.
As described in the RMP, additional risk minimisation activity including educational material will be provided to prescribers.
Kot opisuje načrt za obvladovanje tveganja, bodo predpisovalcem na voljo dodatne aktivnosti za zmanjševanje tveganja, vključno z izobraževalnim gradivom.
Objectives of agomelatine Educational Plan:
Cilj izobraževalnega načrta za agomelatin
The prescriber educational material about Valdoxan / Thymanax will be focused on:
Izobraževalno gradivo za predpisovalce zdravila Valdoxan/ Thymanax se bo osredotočalo na naslednje.
- The potential risks of agomelatine
- Morebitna tveganja agomelatina:
- Interactions with potent CYP 1A2 inhibitors (e. g. fluvoxamine, ciprofloxacin).
zvečanje transaminaz; medsebojno delovanje z močnimi zaviralci CYP 1A2 (npr. fluvoksamin in ciprofloksacin).
- Guidance for hepatic function screening (Need to perform liver function tests in all patients: at initiation
- Navodila za pregledovanje delovanja jeter (delovanje jeter morajo zdravniki pregledovati
of treatment, and then periodically after around six weeks (end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated;
pri vseh bolnikih: ob uvedbi zdravljenja in nato redno, po približno 6 tednih (na koncu akutne faze), 12 tednih in 24 tednih (na koncu vzdrževalne faze) ter pozneje, ko je to klinično indicirano).
- Guidance in case of clinical symptoms or liver function tests abnormality;
- Navodila v primeru, da pregled delovanja jeter pokaže nepravilnosti ali imajo bolniki
- Caution to be exercised when therapy is administered to patients who consume substantial quantities of
- Opozorilo o previdnosti pri predpisovanju bolnikom, ki pijejo znatne količine alkohola ali
alcohol or who are treated with medicinal products associated with risk of hepatic injury;
jemljejo zdravila, povezana s tveganjem za poškodbe jeter.
- Contra-indication in patients with hepatic impairment (i. e. cirrhosis or active liver disease);
- Kontraindikacijo pri bolnikih z jetrno okvaro (to je cirozo ali aktivnimi boleznimi jeter).
- Contra-indication in patients receiving concomitantly potent CYP1A2 inhibitors.
- Kontraindikacijo pri bolnikih, ki sočasno jemljejo močne zaviralce CYP1A2.
It is available as orange- yellow, oblong tablets (25 mg).
Na voljo je v obliki oranžno - rumenih, podolgovatih tablet (25 mg).
Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.
Huda depresija je stanje, za katerega so pri bolnikih značilne motnje razpoloženja, ki posegajo v vsakodnevno življenje.
Symptoms often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, a feeling of being slowed down, feelings of anxiety and changes in weight.
Pogosti simptomi so globoka žalost, občutki ničvrednosti, izguba zanimanja za najljubše dejavnosti, motnje spanja, občutek upočasnjenosti, občutki anksioznosti in spremembe telesne mase.
The recommended dose of Thymanax is one tablet once a day, taken at bedtime with or without food.
Priporočeni odmerek zdravila Thymanax je ena tableta dnevno, ki se vzame pred spanjem s hrano ali brez nje.
Patients with depression should be treated for at least six months to make sure that they are free of symptoms.
Bolniki z depresijo naj se zdravijo vsaj šest mesecev, da se zagotovi, da so brez simptomov.
The patient’ s liver should be checked with blood tests when treatment starts, and then after around six, 12 and 24 weeks of treatment The liver should also be checked if the patient develops symptoms that could indicate liver problems.
Ob začetku zdravljenja ter ponovno po približno šestih, 12 in 24 tednih zdravljenja je treba s krvnimi preiskavami preveriti delovanje bolnikovih jeter.
Treatment should be interrupted in patients with abnormal liver enzyme levels in the blood.
Če se pri bolniku razvijejo simptomi, ki bi lahko kazali na jetrne težave, je treba prav tako preveriti delovanje jeter.
Blood tests should then be repeated until the liver enzymes have returned to normal levels.
Pri bolnikih z neobičajno ravnjo jetrnih encimov v krvi je treba zdravljenje prekiniti.
Because a benefit of Thymanax has not been shown clearly in patients aged over 65 years, it should be used with caution in this age group.
Koristi zdravila Thymanax pri bolnikih, starejših od 65 let, niso bile jasno dokazane, zato ga je v tej starostni skupini treba uporabljati previdno.
It should also be used with caution in patients with moderate or severe kidney problems.
Prav tako ga je treba uporabljati previdno pri bolnikih z zmernimi ali hudimi ledvičnimi težavami.
It must not be used in patients who have liver problems.
Ne sme se uporabljati pri bolnikih z jetrnimi težavami.
It works in two ways, both by stimulating the MT1 and MT2 receptors, which are normally activated by melatonin, and also by blocking the 5-HT 2C receptors, which are normally activated by the neurotransmitter 5-hydroxytryptamine (also called serotonin).
Deluje na dva načina; spodbuja receptorje MT1 in MT2, ki jih običajno aktivira melatonin, ter zavira receptorje 5- HT 2C, ki jih običajno aktivira nevrotransmiter 5- hidroksitriptamin (imenovan tudi serotonin).