natgillin/translations-raw huggingface dataset:
Make sure you tell your doctor if you are taking any medicines which cause sleepiness as thalidomide may increase their effects.
Zdravniku ne smete pozabiti povedati, če jemljete kakršna koli zdravila, ki povzročajo zaspanost, saj lahko talidomid poveča njihov učinek.
Taking Thalidomide Celgene with food and drink:
Jemanje zdravila Thalidomide Celgene skupaj s hrano in pijačo:
Thalidomide Celgene can be taken with or without food (see section 3, “How to take Thalidomide Celgene”).
Zdravilo Thalidomide Celgene se lahko jemlje s hrano ali brez (glejte Poglavje 3 „ Kako jemati zdravilo Thalidomide Celgene “).
Thalidomide causes severe birth defects or death to an unborn baby. • As little as one capsule taken by a pregnant woman can cause a baby to have serious birth defects. • These defects can include shortened arms or legs, malformed hands or feet, eye or ear defects, and problems with internal organs.
Talidomid povzroča resne prirojene okvare ali smrt nerojenega otroka. • Že samo ena kapsula, ki jo vzame nosečnica, lahko povzroči resne prirojene okvare. • Te okvare lahko vključujejo krajše roke ali noge, deformirane roke in stopala, okvare oči in ušes ter težave pri notranjih organih.
You must use one effective method of contraception if you are a woman who is able to become pregnant (see section 2, “Take special care with Thalidomide Celgene”).
Če lahko zanosite, morate uporabljati učinkovito kontracepcijsko metodo (glejte poglavje 2, „ Bodite posebno pozorni pri uporabi zdravila Thalidomide Celgene “).
You must stop treatment and inform your doctor straight away if: • You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant. • You have heterosexual intercourse without using an effective method of contraception.
Takoj morate prekiniti zdravljenje in obvestiti svojega zdravnika, če: • vam je izostala menstruacija ali domnevate, da vam je izostala, ali imate neobičajne menstrualne krvavitve ali sumite, da ste noseči; • imate heteroseksualne spolne odnose brez uporabe učinkovite kontracepcijske metode.
If you do become pregnant during the treatment with thalidomide, you must stop the treatment and inform your doctor immediately.
Če v času zdravljenja s talidomidom zanosite, morate zdravljenje takoj prekiniti in o tem obvestiti svojega zdravnika.
For men taking Thalidomide Celgene who have a female partner who is able to become pregnant, please see section 2 “Take special care with Thalidomide Celgene”.
Za moške, ki jemljejo zdravilo Thalidomide Celgene in imajo partnerico, ki lahko zanosi, glejte poglavje 2 „ Bodite posebno pozorni pri uporabi zdravila Thalidomide Celgene “.
Driving and using machines:
Vpliv na sposobnost vožnje in upravljanje s stroji:
Do not drive or use any tools or machines if you experience side effects, such as dizziness, tiredness, sleepiness or blurred vision.
Ne vozite ali uporabljajte kateregakoli orodja ali stroja, če imate neželene učinke kot so omotica, utrujenost, zaspanost ali zamegljen vid.
Important information about some of the ingredients of Thalidomide Celgene:
Pomembne informacije o nekaterih sestavinah zdravila Thalidomide Celgene:
Thalidomide Celgene contains lactose (a type of sugar).
Thalidomide Celgene vsebuje laktozo (vrsto sladkorja).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik rekel, da ne prenašate nekaterih vrst sladkorja, se pred uporabo zdravila posvetujte s svojim zdravnikom.
HOW TO TAKE THALIDOMIDE CELGENE
KAKO JEMATI ZDRAVILO THALIDOMIDE CELGENE Pri jemanju zdravila Thalidomide Celgene natančno upoštevajte zdravnikova navodila.
30 Thalidomide Celgene is not suitable under the age of 18.
29 Zdravilo Thalidomide Celgene ni primerno za bolnike, stare manj kot 18 let.
How much to take:
Koliko vzeti:
However your doctor will choose the dose for you, monitor your progress and may adjust your dose.
Običajni odmerek je 200 mg (4 kapsule) na dan, vendar lahko vaš zdravnik določi odmerek za vas, nadzira napredek in prilagodi odmerek.
Your doctor will tell you how to take Thalidomide Celgene and for how long you will need to take it.
Zdravnik vam bo povedal, kako vzeti zdravilo Thalidomide Celgene in koliko časa ga je treba jemati.
Thalidomide Celgene is taken in treatment cycles, each cycle lasting 6 weeks, in combination with melphalan and prednisone which are taken on days 1 to 4 of each 6 week cycle.
Zdravilo Thalidomide Celgene se jemlje v ciklih zdravljenja, vsak cikel traja 6 tednov v kombinaciji z melfalanom in prednizonom, ki se jemljeta od 1. do 4. dneva vsakega 6- tedenskega cikla.
Taking this medicine: • Take this medicine by mouth • Swallow the capsules whole with a full glass of water • Do not crush or chew • Take the capsules as a single dose before going to bed.
Jemanje tega zdravila: • Zdravilo se uporablja peroralno. • Pogoltnite cele kapsule s polnim kozarcem vode. • Kapsule ne zdrobite ali žvečite. • Kapsule vzemite kot enkraten odmerek pred spanjem.
If you take more Thalidomide Celgene than you should:
Če ste vzeli večji odmerek zdravila Thalidomide Celgene, kot bi smeli:
If you take more Thalidomide Celgene than you should, talk to a doctor or go to a hospital straightaway.
Če ste vzeli večji odmerek zdravila Thalidomide Celgene, kot bi smeli, to povejte zdravniku ali pojdite takoj v bolnico.
If possible, take the medicine pack and this leaflet with you.
Če je možno, s seboj vzemite ovojnino zdravila in ta navodila za uporabo.
If you forget to take Thalidomide Celgene:
Če ste pozabili vzeti zdravilo Thalidomide Celgene:
If you forget to take Thalidomide Celgene at your regular time and • less than 12 hours have passed: take your capsule immediately. • more than 12 hours have passed: do not take your capsule.
Če ste pozabili vzeti odmerek zdravila Thalidomide Celgene ob običajnem času in • je minilo manj kot 12 ur: nemudoma vzemite kapsulo. • je minilo več kot 12 ur: ne vzemite kapsule.
Take your next capsule at the usual time the next day.
Naslednjo kapsulo vzemite ob običajni uri naslednji dan.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Če imate kakršnakoli dodatna vprašanja glede uporabe tega zdravila, se posvetujte s svojim zdravnikom ali s farmacevtom.
POSSIBLE SIDE EFFECTS Like all medicines, Thalidomide Celgene can cause side effects although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Thalidomide Celgene neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The frequency of side effects is classified into the following categories:
Pogostost neželenih učinkov je razvrščena v naslednje kategorije:
Very common Common Uncommon Rare Very rare
Zelo pogosti Pogosti Občasni Redki Zelo redki
In more than 1 in 10 patients In more than 1 in 100 patients, but less than 1 in 10 In more than 1 in 1,000 patients, but less than 1 in 100 In more than 1 in 10,000 patients but less than 1 in 1000 patients In less than 1 in 10,000 patients
Pri več kot 1 od 10 bolnikov Pri več kot 1 od 100 bolnikov, a manj kot 1 od 10 Pri več kot 1 od 1. 000 bolnikov, a manj kot 1 od 100 Pri več kot 1 od 10. 000 bolnikov vendar manj kot 1 od 1. 000 Pri manj kot 1 od 10. 000 bolnikov
Stop taking Thalidomide Celgene and see a doctor straight away if you notice the following serious side effects – you may need urgent medical treatment: • Severe skin reactions including rashes, which is a common side effect and blistering of the skin and mucosa (Stevens Johnson Syndrome and toxic epidermal necrolysis, which are rare side effects).
Prekinite z jemanjem zdravila Thalidomide Celgene in se takoj napotite k zdravniku, če opazite sledeče resne neželene učinke – morda potrebujete nujno medicinsko pomoč: • Resne kožne reakcije vključno z osipom, ki je pogost neželen učinek, in mehurji kože in sluznice (Stevens Johnsonov sindrom in toksična epidermalna nekroliza, ki sta redka neželena učinka).
Tell your doctor straight away if you notice any of the following serious side effects: • Numbness, tingling, abnormal co-ordination or pain in your hands and feet.
Takoj obvestite zdravnika, če opazite kateregakoli od naslednjih resnih neželenih učinkov: • Otrplost, ščemenje, nenavadna koordinacija ali bolečine v rokah ali nogah.
This may be due to nerve damage (called ‘peripheral neuropathy’), which is a very common side effect.
Vzrok je lahko okvara živcev (imenuje se "periferna nevropatija"), ki je zelo pogost neželeni učinek.
This side effect usually happens after you have been taking this medicine for several months but can happen sooner than this.
Ta neželeni učinek običajno nastopi, ko to zdravilo jemljete več mesecev, vendar lahko nastopi tudi
It can also happen some time after treatment has stopped.
Lahko nastopi tudi nekaj časa po koncu zdravljenja.
It may not go away, or may go away slowly. • Sudden pain in your chest or difficulty in breathing.
Lahko se zgodi, da sploh ne izgine ali izgine počasi. • Nenadna bolečina v prsih ali težko dihanje.
31 This may be due to blood clots in the artery leading to your lungs (called ‘pulmonary embolism’), which is a common side effect.
Vzrok so lahko krvni strdki v arteriji, ki vodi do vaših pljuč (imenuje se "pljučna embolija"), ki je pogost neželeni učinek.
These can happen during treatment, or after treatment has stopped. • Pain or swelling in your legs, especially in your lower leg or calves.
Do tega lahko pride med zdravljenjem ali ko je zdravljenje že končano. • Bolečina ali zatekanje nog, zlasti v nižjem delu nog ali mečih.
Very common • Constipation. • Feeling dizzy. • Sleepiness, feeling tired. • Shaking (tremor). • Swelling of hands and feet. • Numbness and tingling • Low blood cell counts.
Zelo pogosti • zaprtje • omotica • zaspanost, utrujenost • tresavica (tremor) • zatekanje rok in nog • otrplost in ščemenje • Nizka koncentracija krvničk.
This may mean that you are more likely to develop infections.
To lahko pomeni, da pri vas obstaja večja verjetnost razvoja okužb.
Uncommon • Having difficulty seeing or speaking due to bleeding from an artery in the brain. • Feeling dizzy when you stand up. • Inflammation and swelling of the tubes in your lungs (bronchitis). • Inflammation of the cells lining your stomach wall. • A hole in part of your large bowel (colon) which can cause infection.
Pogosti • prebavne težave, slabo počutje (navzea), občutek slabosti (bruhanje), suha usta • izpuščaji, izsušenost kože • slabotnost, omedlevica ali nestanovitnost, pomanjkanje energije ali moči, nizek krvni tlak • povišana telesna temperatura, splošno slabo počutje • vrtoglavica, težave pri stanju pokonci in normalnem premikanju • kratkotrajne težave pri gledanju ali govorjenju, ki so lahko posledica krvnega strdka v arteriji v možganih • zamegljen vid • kratka sapa, težko dihanje • okužbe prsnega koša (pljučnica), bolezni pljuč • počasen srčni utrip, odpoved srca • depresija, zmedenost, spremembe razpoloženja, tesnoba Občasni • težave pri gledanju in govorjenju zaradi krvavitve v arteriji v možganih • vrtoglavica, ko vstanete • vnetje in zatekanje pljučnih žil (bronhitis) • vnetje celic v steni želodca • luknja v delu debelega črevesa (debelo črevo), ki lahko povzroči okužbo
Additional side effects have been reported after this medicine was marketed.
O dodatnih neželenih učinkih so poročali po uvedbi zdravila na trg.
These include • very serious skin reaction (toxic epidermal necrolysis) • underactive thyroid (hypothyroidism) • bowel obstruction • sexual dysfunction, for example impotence.
Slednji vključujejo • zelo resno kožno reakcijo (toksično epidermalno nekrolizo) • zmanjšano aktivnost ščitnice (hipotiroidizem), • obstrukcijo črevesja • spolno disfunkcijo, na primer impotenco
HOW TO STORE THALIDOMIDE CELGENE
SHRANJEVANJE ZDRAVILA THALIDOMIDE CELGENE
Keep out of the reach and sight of children and any other person not directly involved in the treatment.
Zdravilo shranjujte nedosegljivo otrokom in vsem drugim osebam, ki niso neposredno vpletene v zdravljenje.
Do not use after the expiry date stated on the wallet card and the blister after EXP.
31 Zdravila Thalidomide Celgene ne smete uporabljati po datumu izteka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP.
This medicine does not require any special storage conditions.
To zdravilo ne zahteva posebnih navodil za shranjevanje.
32 At the end of your treatment you should return all unused capsules to the pharmacist or doctor.
Na koncu vašega zdravljenja morate vse neuporabljene kapsule vrniti farmacevtu ali zdravniku.
What Thalidomide Celgene contains: • The active substance is thalidomide.
DODATNE INFORMACIJE Kaj vsebuje zdravilo Thalidomide Celgene: • Zdravilna učinkovina je talidomid.
Each capsule contains 50mg of thalidomide. • The other ingredients are anhydrous lactose, microcrystalline cellulose, povidone (K90), stearic acid, colloidal anhydrous silica, and crospovidone (Type A).
Ena kapsula vsebuje 50 mg talidomida. • Pomožne snovi so brezvodna laktoza, mikrokristalna celuloza, povidon 90, stearinska kislina, brezvoden koloidni silicijev dioksid in krospovidon (vrste A).
The capsule shell contains gelatin and titanium dioxide (E171).
Ovoj kapsul vsebuje želatino in titanov dioksid (E171).
The printing ink is composed of shellac, black iron oxide (E172) and propylene glycol.
Črnilo vsebuje šelak, črn železov oksid (E172) in propilenglikol.
What Thalidomide Celgene looks like and contents of the pack:
Izgled zdravila Thalidomide Celgene in vsebina pakiranja:
Thalidomide Celgene are white hard capsules marked “Thalidomide 50 mg Celgene”.
Thalidomide Celgene so bele trde kapsule, označene s „ Thalidomide 50 mg Celgene “.
Celgene Europe Ltd, Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom.
Celgene Europe Ltd, Riverside House, Riverside Walk, Windsor, SL4 1NA, Velika Britanija.
Penn Pharmaceuticals Ltd, Tafarnaubach Industrial Estate, Tredegar, Gwent, NP22 3AA, United Kingdom.
Penn Pharmaceuticals Ltd, Tafarnaubach Industrial Estate, Tredegar, Gwent, NP22 3AA, Velika Britanija.
Thelin are capsule-shaped, yellow-to-orange tablets containing 100 mg of the active substance sitaxentan sodium
Zdravilo Thelin so rumene do oranžne tablete v obliki kapsule, ki vsebujejo 100 mg zdravilne učinkovine natrijev sitaksentanat.
Thelin is used for the treatment of adult patients with class III pulmonary arterial hypertension, to improve exercise capacity.
Thelin se uporablja za zdravljenje odraslih bolnikov s pljučno arterijsko hipertenzijo III. razreda za izboljšanje vadbene zmogljivosti.
Pulmonary arterial hypertension is a disease where the patient has an abnormally high blood pressure in the arteries of the lungs; class III ‘ moderate ’ reflects the seriousness of the disease.
Pljučna arterijska hipertenzija pomeni nenormalno visok krvni tlak v pljučnih arterijah, medtem ko razred III (“ zmerna ”) odraža resnost bolezni.
Thelin has been shown to be effective in primary (no other cause) pulmonary hypertension and pulmonary hypertension caused by connective tissue disease.
Zdravilo Thelin se je izkazalo kot učinkovito pri primarni (brez drugega vzroka) pljučni hipertenziji in pri pljučni hipertenziji, katere vzrok je bolezen vezivnega tkiva.
Because the number of patients with pulmonary arterial hypertension is low, the disease is rare, and Thelin was designated an ‘ orphan medicine’ (a medicine used in rare diseases) on 21 October 2004.
Ker je število bolnikov s primarno pljučno hipertenzijo majhno in je bolezen redka, je bilo zdravilo Thelin dne 21. oktobra 2004 določeno kot ‘ zdravilo sirota ’ (zdravilo za redke bolezni).
Thelin treatment should only be started and monitored by a doctor who has experience in the treatment of pulmonary arterial hypertension.
Zdravljenje z zdravilom Thelin lahko uvede in spremlja le zdravnik, ki ima izkušnje z zdravljenjem pljučne arterijske hipertenzije.
It is taken as 100 mg (one tablet) a day, with or without food, preferably at the same time of the day, and the dose should not be increased to more than one tablet a day.
Odmerka se ne sme povečati na več kot eno tableto dnevno.
It should not be taken by patients who have or have had a serious liver problem.
Zdravila ne smejo jemati bolniki, ki imajo ali so imeli resne težave z jetri.
If after 12 weeks the patient’ s condition is getting worse, then the doctor should review the treatment.
Če se po 12 tednih stanje bolnika poslabša, mora zdravnik preveriti zdravljenje.
Pulmonary arterial hypertension is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs causing very high blood pressure in the vessels taking blood from the right side of the heart to the lungs.
Pljučna arterijska hipertenzija je izčrpavajoča bolezen, pri kateri pride do hude konstrikcije (zoženja) krvnih žil v pljučih, kar povzroči zelo visok krvni tlak v žilah, po katerih se pretaka kri iz desne strani srca v pljuča.
The active substance in Thelin, sitaxentan sodium, opposes the effect of a naturally occurring substance called endothelin-1 (ET-1), which causes a severe constriction of the blood vessels.
Zdravilna učinkovina v zdravilu Thelin, natrijev sitaksentanat, zavira učinek naravno prisotne snovi, imenovane endotelin- 1 (ET- 1), ki povzroča hudo zoževanje krvnih žil.
By blocking the effect of endothelin, it reduces the constriction of the vessels and this helps decrease the blood pressure.
Z blokiranjem učinka endotelina se zmanjša zoževanje žil, kar pomaga pri zniževanju krvnega tlaka.
(44-20) 74 18 84 00, Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Thelin been studied?
(44- 20) 74 18 84 00, Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Thelin raziskano?
The safety and efficacy of Thelin were first tested in experimental models before being studied in humans.
Varnost in učinkovitost zdravila Thelin sta bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so ju raziskali pri ljudeh.
Three main studies were carried out in 523 patients.
Izvedene so bile tri večje študije, v katerih je sodelovalo 523 bolnikov.
Doses of 50 mg, 100 mg and 300 mg of sitaxentan sodium were compared with placebo (dummy treatment).
V njih so primerjali natrijev sitaksentanat v odmerkih 50 mg, 100 mg in 300 mg s placebom (zdravilom brez zdravilne učinkovine).
The effectiveness was studied by measuring the distance the patients could walk in 6 minutes after at least 12 weeks of treatment.
Učinkovitost so merili z razdaljo, ki so jo bolniki lahko prehodili v 6 minutah po najmanj 12 tednih zdravljenja.
What benefit has Thelin shown during the studies?
Kakšne koristi je zdravilo Thelin izkazalo med raziskavami?
Patients could walk significantly further after treatment with Thelin.
Po zdravljenju z zdravilom Thelin so lahko bolniki prehodili bistveno večjo razdaljo.
Before treatment with 100 mg sitaxentan sodium the average walking distance was between 343 and 394 metres, and this increased by about 33 metres after treatment.
Pred zdravljenjem s 100 mg natrijevega sitaksentanata je povprečna prehojena razdalja znašala med 343 in 394 metri, po zdravljenju pa se je povečala za 33 metrov.
This is not a large increase but it is a significant improvement.
Povečanje sicer ni veliko, vendar pomeni znatno izboljšanje.
The studies demonstrated that the 50 mg dose did not have a relevant benefit and the 300 mg dose did not show better efficacy than the 100 mg dose.
Raziskave so pokazale, da 50 mg odmerek ne daje bistvenih koristi in da 300 mg odmerek ni bolj učinkovit od 100 mg odmerka.
The most common side effect (seen in more than 1 patient in 10) is headache.
Najpogostejši stranski učinek (opažen pri več kot 1 od 10 bolnikov) je glavobol.
Other common side effects (between 1 and 10 patients in 100) are peripheral oedema (swelling of arms and legs), and nasal congestion (blocked nose).
Ostala pogosta stranska učinka (opažena pri 1 do 10 bolnikih od 100) sta periferni edem (otekanje rok in nog) in zamašen nos.
For the full list of all side effects reported with Thelin, see the Package Leaflet.
Celovit seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Thelin, najdete v Navodilih za uporabo.
Thelin should not be used in people who may be hypersensitive (allergic) to sitaxentan sodium or any of the other ingredients, who have a serious liver problem or raised levels of some liver enzymes.
Zdravila Thelin ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) natrijev sitaksentanat ali katerokoli drugo sestavino, ki imajo resne težave z jetri ali povišano raven nekaterih jetrnih encimov.
The patient ’ s liver function should be monitored before and during the treatment.
Pred in po zdravljenju je treba pri bolniku spremljati delovanje jeter.
Thelin should not be taken with cyclosporin A (a medicine used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of liver or kidney transplant) and care should be taken when it is taken at the same time as warfarin (a medicine used to thin blood).
Zdravila Thelin se ne sme jemati skupaj s ciklosporinom A (zdravilom za zdravljenje psoriaze in revmatoidnega artritisa in za preprečevanje zavrnitve presadka jeter ali ledvic), previdnost pa je potrebna tudi, če se Thelin jemlje sočasno z varfarinom (zdravilom za redčenje krvi).
Women taking Thelin should take care not to become pregnant, they need to use an effective contraception.
Uporabljati morajo učinkovita kontracepcijska sredstva.
It is unknown whether or not sitaxentan is excreted into human milk or if it could harm a nursing baby.
Ni znano, ali se natrijev sitaksentanat izloča v človeško materino mleko in ali bi utegnil škodovati dojenemu otroku.
Breastfeeding should be avoided while using Thelin.
Ženske med uporabo zdravila Thelin ne smejo dojiti.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Thelin had shown its effectiveness, and that this effectiveness was as expected for this class of medicines.
Odbor za zdravila za uporabo v humani medicini (CHMP) je prišel do zaključka, da je zdravilo Thelin izkazalo svojo učinkovitost in da je bila le- ta v skladu s pričakovano učinkovitostjo tega razreda zdravil.
They decided that Thelin’ s benefits are greater than its risks for the treatment of adult patients with pulmonary primary arterial hypertension to improve exercise capacity and pulmonary hypertension caused by connective tissue disease.
Odbor je zato odločil, da so koristi zdravila Thelin pri zdravljenju odraslih bolnikov s primarno pljučno arterijsko hipertenzijo za izboljšanje vadbene zmogljivosti in zdravljenju pljučne hipertenzije, katere vzrok je bolezen vezivnega tkiva, večji od z njim povezanih tveganj.
They recommended that Thelin be given marketing authorisation.
Zato je za zdravilo Thelin priporočil odobritev dovoljenja za promet z zdravilom.
Which measures are being taken to ensure the safe use of Thelin?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Thelin?
The company that makes Thelin will provide educational information to doctors and patients (patient information card).
Podjetje, ki proizvaja Thelin, bo zdravnikom in bolnikom zagotovilo informacije izobraževalne narave (informativno obvestilo za bolnike).
The company will also set up a system to monitor side effects, suspected interactions with other medicines and outcome of any pregnancy that may happen in women using the medicine.
Poleg tega bo proizvajalec vzpostavil sistem za spremljanje stranskih učinkov, domnevnih interakcij z ostalimi zdravili in izide nosečnosti, do katerih je prišlo pri ženskah, ki jemljejo to zdravilo.
The European Commission granted a marketing authorisation valid throughout the European Union for Thelin to Encysive (UK) Ltd on 10 August 2006.
Evropska komisija je dovoljenje za promet z zdravilom Thelin, veljavno po vsej Evropski uniji, odobrila družbi Encysive (Združeno kraljestvo) Ltd dne 10. avgusta 2006.